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Objectives We systematic ally assessed r and omized controlled trials comparing direct pulp capping material s. Methods Trials comparing material s for direct capping and evaluating clinical ly and /or radiographically determined success after minimum 3 months were included . Two review ers independently screened electronic data bases ( Medline , Central , Embase ) and performed h and search es . Risk of bias was assessed and meta-analyses were performed , separated for dentition . Trial sequential analysis was used to assess risk of r and om errors . Strength of evidence was grade d using the GRADE approach . Results From a total of 453 identified studies , 11 ( all with high risk of bias ) investigating 1094 teeth ( 922 patients ) were included . Six studies were on primary teeth ( all with carious exposures ) and five on permanent teeth ( carious and artificial exposures ) . Mean follow-up was 14 months ( range 3–24 ) . Most studies used calcium hydroxide as control , comparing it to mineral trioxide aggregate ( MTA ) ( three studies ) , bonding without prior etching/conditioning ( two ) , or bonding with prior etching/conditioning , enamel matrix proteins , resin-modified glass ionomer cement , calcium sulfate , zinc oxide eugenol , corticosteroids , antibiotics , or formocresol ( each in only one study ) . One study compared MTA and calcium-enriched cement . In permanent teeth , risk of failure was significantly decreased if MTA instead of calcium hydroxide was used ( risk ratio ( RR ) [ 95 % confidence intervals ( CI ) ] 0.59 [ 0.39/0.90 ] ) ; no difference was found for primary teeth . Other comparisons did not find significant differences or were supported by only one study . No firm evidence was reached according to trial sequential analysis . Conclusion There is insufficient data to recommend or refute the use of a specific material . More long-term practice -based studies with real-life exposures are required . Clinical relevance To reduce risk of failure , dentists might consider using MTA instead of calcium hydroxide ( CH ) for direct capping . Current evidence is insufficient for definitive recommendations
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"INTRODUCTION The aim of this trial was to compare clinical and radiographic success rates of direct pulp capping ( DPC ) using a novel bio material called Calcium Enriched Mixture ( CEM ) cement versus Mineral Trioxide Aggregate ( MTA ) in primary molar teeth . MATERIAL S AND METHODS In this r and omized clinical trial 42 deciduous molars in 21 patients who had at least two teeth requiring DPC , were treated . The enrolled patients were between 5 - 8 years . The molar teeth were r and omly divided into two experimental groups . Patients and operators were blinded . The teeth were anaesthetized , caries were removed and after pinpoint exposure of dental pulp , haemostasis was achieved . The exposure points were capped with MTA or CEM cement . All teeth were restored with amalgam . Patients were recalled for the 6-month follow up . Statistical analysis was carried out using McNemar test . RESULTS Thirty-eight teeth were available for follow up ( 19 in each group ) . The radiographic evaluations did not show failure in experimental groups ; however , in clinical examinations one sinus tract was found in CEM cement group . Clinical success rates in CEM cement and MTA groups were 94.8 % and 100 % , respectively . Dentinal bridge formation was not observed in the two experimental groups . CONCLUSION There is no significant difference between treatment outcomes of direct pulp capping with either CEM cement or MTA ; therefore , both bio material s can be used successfully for DPC in primary molar teeth",
"Introduction The aim of this r and omized controlled trial was to compare the radiographic and clinical success rates of direct pulp capping ( DPC ) using ProRoot mineral trioxide aggregate ( MTA ) or calcium enriched mixture ( CEM ) . Methods and Material s A total of 42 symptom-free carious vital primary molars ( 21 pairs ) were selected in this split mouth trial and r and omly pulpotomized in two experimental groups . Pinpoint pulp exposures were covered by the same blinded operator with MTA or CEM , and then restored by amalgam . Radiographic and clinical successes were evaluated at 20 month follow-up . Data were statistically analyzed using McNemar test . Results Nineteen patients were available for 20-month follow-up ; only one failed tooth was extracted in the CEM group . All available teeth were symptom-free , however , the final evaluated success rate was 89 % in CEM ( CI 95 % : 0.82 - 0.96 ) and 95 % in MTA ( CI 95 % : 0.85 - 1 ) groups without statistical difference ( P=0.360 ) . Worst case scenario was applied for missing value analysis ; assuming that the 2 lost cases in CEM group had failed and the only lost case in MTA group was due to treatment success , as a result the success of CEM and MTA were 81 % ( CI 95 % : 0.72 - 0.90 ) and 95 % ( CI 95%:0.85 - 1 ) , respectively , with no statistical difference ( P=0.078 ) . In the reverse scenario , the success of MTA and CEM were 86 % ( CI 95 % : 0.78 - 0.94 ) and 90 % ( CI 95 % : 0.82 - 0.98 ) , respectively ; again with no statistical difference ( P=0.479 ) . Conclusion Effectiveness of MTA and CEM bio material s for primary molars ’ DPC was similar ; CEM can be a suitable alternative for MTA",
"AIM To evaluate the clinical and radiological response of primary molars to direct pulp capping with calcium sulfate hemihydrate . MATERIAL S AND METHODS Forty primary molar teeth in 40 healthy children aged 5 - 9 years were treated by direct pulp capping . Teeth were r and omly assigned to two groups ( n=20 ) according to material used for capping , as follows : Group 1 : calcium hydroxide cement ( Dycal ) ; Group 2 : calcium sulfate hemihydrate ( Dentogen ) . All teeth were restored with a conventional glass ionomer base ( Fuji IX ) and amalgam . RESULTS After 12 months , the overall success rate of direct pulp capping was approximately 75 % ( 24/32 teeth , excluding exfoliations ) . The success rate did not differ significantly between calcium hydroxide and calcium sulfate hemihydrate treatment . CONCLUSION Calcium sulfate hemihydrate was found to be as successful as calcium hydroxide for direct pulp capping of primary molars with Class I cavities . Further histological studies are needed to support these findings",
"Blinding embodies a rich history spanning over two centuries . Most research ers worldwide underst and blinding terminology , but confusion lurks beyond a general comprehension . Terms such as single blind , double blind , and triple blind mean different things to different people . Moreover , many medical research ers confuse blinding with allocation concealment . Such confusion indicates misunderst and ings of both . The term blinding refers to keeping trial participants , investigators ( usually health-care providers ) , or assessors ( those collecting outcome data ) unaware of the assigned intervention , so that they will not be influenced by that knowledge . Blinding usually reduces differential assessment of outcomes ( information bias ) , but can also improve compliance and retention of trial participants while reducing biased supplemental care or treatment ( sometimes called co-intervention ) . Many investigators and readers naïvely consider a r and omised trial as high quality simply because it is double blind , as if double-blinding is the sine qua non of a r and omised controlled trial . Although double blinding ( blinding investigators , participants , and outcome assessors ) indicates a strong design , trials that are not double blinded should not automatically be deemed inferior . Rather than solely relying on terminology like double blinding , research ers should explicitly state who was blinded , and how . We recommend placing greater credence in results when investigators at least blind outcome assessment s , except with objective outcomes , such as death , which leave little room for bias . If investigators properly report their blinding efforts , readers can judge them . Unfortunately , many articles do not contain proper reporting . If an article cl aims blinding without any accompanying clarification , readers should remain sceptical about its effect on bias reduction",
"In r and omised controlled trials , allocation concealment ( separating the process of r and omisation from the recruitment of participants ) is important for rigorously design ed trials.1–4 In 1996 many major medical journals adopted the CONSORT statement ( whereby research ers have to include a short checklist of essential items and a flow diagram when reporting trials),5 and this move encouraged the reporting of allocation concealment . We review ed the prevalence of adequate allocation concealment and its association with the statistical significance of trial results . We search ed by h and four general medical journals ( the BMJ , JAMA , the Lancet , and the New Engl and Journal of Medicine ) to identify r and omised controlled trials published from January 2002 to December 2002 . We included articles if the authors reported that participants were r and omised and if the trial was published as a full report with the results of the main analyses . We categorised articles according to whether allocation concealment was adequate ( the person who executed the allocation sequence was different from the person who recruited",
"PURPOSE To evaluate the clinical , radiographical and histological findings in human third molars in which mechanical pulp exposures were capped with white ProRoot mineral trioxide aggregate ( WMTA ) . METHODS Forty-eight human third molars , caries-free or with incipient caries , scheduled to be extracted , were used and r and omly divided into two groups : Group A : ( n= 24 ) received WMTA and control Group B : ( n= 24 ) received chemical set calcium hydroxide ( Dycal ) . The teeth were isolated with rubber dam and Class I cavities prepared . Pulp exposure was performed using a sterile diamond bur and confirmed by frank bleeding . A sterile cotton pellet dipped in saline solution was placed over the exposure for 60 seconds . The preparation was then lightly rinsed with water and gently air-dried . WMTA or CH was placed over the exposure site followed by a small amount of a light-cured compomer . After etching with 35 % phosphoric acid gel for 15 seconds , rinsing and blot drying , Prime and Bond NT adhesive was applied and light-cured . The cavity was then restored with a resin composite and light-cured . Evaluations were performed by phone after 7 days and clinical ly at 30 + /- 5 and 136 + /- 24 days , using st and ardized tests and radiographs . The teeth were extracted after 136 + /- 24 days ; the roots were cut + /- 4 - 5 mm from the apex to allow for rapid fixation in 10 % neutral buffered formalin . They were then processed for routine histological evaluation , embedded in paraffin , sectioned and stained with hematoxylin and eosin and Brown and Brenn for recognition of bacteria . Statistical analyses were performed using a Mann-Whitney U-test , a Chi-square test , a Fisher 's exact test and an ANOVA . RESULTS No significant differences in post-operative sensitivity were reported after 7 days between the two material s ( P > 0.05 ) . Clinical examination demonstrated no significant differences at 30 + /- 5 days ( P > 0.05 ) and at 136 + /- 24 days ( P > 0.05 ) . Histological findings : 45 of 48 teeth were suitable for microscopic evaluation ( 22 with WMTA and 23 with CH ) . Twenty from the WMTA and 18 from the CH group had developed a bridge . No statistically significant differences were found for superficial and deep inflammatory cell response ( P > 0.05 ) , presence of a dentin bridge ( P > 0.01 ) , and pulp vitality ( P > 0.01 ) , between WMTA and calcium hydroxide . A statistically significant difference was found for the diameter of exposure ( P clinical and histological findings could be established for either material",
"PURPOSE To evaluate , prospect ively , the clinical and radiological response of primary molars , pulp-capped with calcium hydroxide and different adhesive systems after hemorrhage control with 1.25 % sodium hypochlorite ( NaOCl ) . METHODS 100 primary molar teeth were pulp-capped in 67 children who met inclusion criteria . Hemorrhage at the exposure site was controlled with 60 seconds application of 1.25 % NaOCl . Teeth were r and omly assigned into five groups ( n=20 each ) with respect to the material /technique used for capping : ( 1 ) calcium hydroxide cement ( Dycal ) ; ( 2 ) acetone-based total-etch adhesive ( Prime&Bond NT ) ; ( 3 ) a non-rinse conditioner ( NRC ) and Prime&Bond NT ; ( 4 ) total-etching with 36 % phosphoric acid followed by Prime&Bond NT ; and ( 5 ) a self-etch adhesive system ( Xeno III ) . Teeth in Group 1 were restored with amalgam and Groups 2 - 5 with polyacid-modified resin-based composite ( Dyract AP ) . The teeth were evaluated clinical ly and radiographically for 24 months . Marginal integrity of the restorations was also recorded at recall periods using modified USPHS/Ryge criteria . RESULTS After 2 years , the overall success rate of direct pulp capping was approximately 93 % ( 78/84 teeth , excluding exfoliations ) . The Dycal and Prime&Bond NT groups did not exhibit any clinical or radiographic failure . A majority of failures were observed in teeth that received NRC and phosphoric acid pretreatments ( Groups 3 and 4 ) . Clinical symptoms were seldom associated with failed teeth . Only one tooth failed in the Xeno III group . Marginal integrity scores were not compatible with the clinical / radiographic outcome",
"This practice -based , r and omized clinical trial evaluated and compared the success of direct pulp capping in permanent teeth with MTA ( mineral trioxide aggregate ) or CaOH ( calcium hydroxide ) . Thirty-five practice s in Northwest PRECEDENT were r and omized to perform direct pulp caps with either CaOH ( 16 practice s ) or MTA ( 19 practice s ) . Three hundred seventy-six individuals received a direct pulp cap with CaOH ( n = 181 ) or MTA ( n = 195 ) . They were followed for up to 2 yrs at regular recall appointments , or as dictated by tooth symptoms . The primary outcomes were the need for extraction or root canal therapy . Teeth were also evaluated for pulp vitality , and radiographs were taken at the dentist ’s discretion . The probability of failure at 24 mos was 31.5 % for CaOH vs. 19.7 % for MTA ( permutation log-rank test , p = .046 ) . This large r and omized clinical trial provided confirmatory evidence for a superior performance with MTA as a direct pulp-capping agent as compared with CaOH when evaluated in a practice -based research network for up to 2 yrs ( Clinical Trials.gov NCT00812887 )",
"The purpose of this study was to evaluate polymicrobial coronal leakage of mineral trioxide aggregate ( MTA ) and amalgam . There were 108 single-rooted teeth r and omly divided into 3 groups of 32 teeth each and positive and negative control groups of 6 teeth and obturated with gutta percha and either Diaket ( 3M/ESPE , Seefeld , Germany ) , AH Plus ( Dentsply , De Trey , Konstanz , Germany ) , or Ketac Endo ( 3M/ESPE ) . These groups were further divided into 2 subgroups of 16 teeth in which root ends were resected and obturated with either MTA or zinc-free amalgam . The sample s have been incorporated in a dual-chamber leakage model with a polymicrobial marker of five facultative anaerobes on the coronal part . Leakage was observing during a period of 90 days . The least leakage was found in a combination of Diaket and MTA ( 76.9 + /-14.8 days ) followed by AH Plus and MTA ( 66.1 + /- 18.7 ) , Diaket and amalgam ( 60.0 + /- 23.1 ) , AH Plus and amalgam ( 56.9 + /- 22.1 ) , and Ketac Endo and MTA ( 42.1 + /- 17.8 ) , whereas the greatest leakage was observed in the Ketac Endo and amalgam group ( 40.0 + /- 17.24 ) . Sample s filled with MTA showed significantly better sealing than sample s filled with amalgam ( p < 0.05 )",
"OBJECTIVE The aim was to compare the clinical and radiographic efficacy of enamel matrix derivative and self-hardening calcium hydroxide as direct pulp capping material s on decayed primary molars , with observation periods of 1 , 6 , and 12 months . STUDY DESIGN A clinical , r and omized , controlled trial was performed , following the \" split-mouth \" design . A total of 90 primary molars were treated . Assignation of material s and operative initial side were selected in a r and omized manner . Five outcome variables were considered : internal dentin resorption , pain , gingival sinus tract , root external resorption , and pathologic mobility . The appearance of any of these signs or symptoms was considered to be a failure of treatment . RESULTS Significant statistical or clinical differences were not found between the study groups . Two treatments were judged as failures , 1 per study group ; both occurred during the first postoperative month . CONCLUSIONS The technique used for direct pulp capping on primary molars in this study is recommended on the basis of the obtained clinical and radiographic results",
"The recent use of sham surgery in r and omized , controlled trials raises three critical questions about research involving human subjects . The first question concerns the tension between the highest st and ard of research design and the highest st and ard of ethics.1 When these two st and ards come into conflict and research ers can not simultaneously meet both , which should prevail , and how should a balance be struck ? The second question points to ongoing uncertainties and disagreements in assessing the risks and benefits of research protocol s. When reasonable people — the members of well-established institutional review boards or the sponsors of research — disagree in their risk – benefit . .",
"Objectives To assess whether structured abstract s improved the sensitivity , precision and yield of retrieving clinical trials , using electronic search es , for example , MEDLINE , from dental journals . Design Retrospective , observational study . Sample Clinical trials , published in six dental journals . Three that adopted structured abstract s ( BDJ , CPJ , JO ) and three that remained unchanged ( JDR , EJO , AJODO ) between January 1995 and December 1998 ( extended to December 2002 for the JO ) . Intervention Adoption of a structured abstract format . Control Continued use of a non-structured abstract format . Method A combination of h and search ing and the Cochrane Collaboration Oral H1ealth Group 's Trials Register and /or CENTRAL were used to identify r and omised controlled trials ( RCTs ) and controlled clinical trials ( CCTs ) over the selected time period . MEDLINE was used to identify clinical trials in the selected journals over the same time period . Results There was no significant difference in the sensitivity or yield of clinical trial retrieval in journals with either abstract format over time . However , there was a significant increase in precision in journals that did not change their format ( OR=4.96 ( 95 % CI 1.18 , 20.86 ) but not those that did . There was no significant difference in the sensitivity or yield of clinical trial retrieval either before or after the change in format or precision of retrieval before the change . However , in the later period , the precision of retrieval was significantly better in journals with unstructured abstract s compared to those with structured abstract s ( OR=0.17 ( 95 % CI 0.04 , 0.7 ) . Conclusion The use of a structured abstract format does not improve the sensitivity , precision or yield of retrieval of clinical trials from MEDLINE"
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BACKGROUND Glass-ionomers are traditionally regarded to be inferior to resin as fissure sealants in protecting teeth from dental caries , due to their comparatively lower retention rate . Unlike low-viscosity glass-ionomers , high-viscosity glass-ionomer cements ( HVGIC ) are placed as sealants by pressing the material into pits and fissures with a petroleum-jelly-coated index finger . Hence , HVGIC sealants are assumed to penetrate pits and fissures deeper , result ing in a higher material retention rate , which may increase its caries-preventive effect . METHODS The aim of this review was to answer the question as to whether , in patients with fully erupted permanent molar teeth , HVGIC based fissure sealants are less effective to protect against dental carious lesions in occlusal pits and fissures than resin-based fissure sealants ? A systematic literature search in eight data bases was conducted . Heterogeneity of accepted trials and imprecision of the established evidence were assessed . Extracted sufficiently homogenous data sets were pooled by use of a r and om-effects meta- analysis . Internal trial validity was evaluated . The protocol of this systematic review was registered with the International Prospect i ve Register of Systematic Review s ( PROSPERO / Nr . : CRD42015016007 ) . RESULTS Seven clinical trials were provisionally included for further review . Of these , one was excluded . Seven trial reports reporting on six trials were accepted . From these , 11 data sets were extracted and pooled in four meta-analyses . The results suggest no statistically significant differences after up to 48 months and borderline significant differences in favour of HVGIC sealants after 60 months ( RR 0.29 ; 95 % CI : 0.09 - 0.95 ; p = 0.04 / RD -0.07 ; 95 % CI : -0.14 , -0.01 ) . The point estimates and upper confidence levels after 24 , 36 , 48 and 60 months of RR 1.36 ; RR 0.90 ; RR 0.62 ; RR 0.29 and 2.78 ; 1.67 ; 1.21 ; 0.95 , respectively , further suggest a chronological trend in favour of HVGIC above resin-based sealants . The internal trial validity was judged to be low and the bias risk high for all trials . Imprecision of results was considered too high for clinical guidance . CONCLUSION It can be concluded that : ( i ) Inferiority cl aims against HVGIC in comparison to resin-based sealants as current gold-st and ard are not supported by the clinical evidence ; ( ii ) The clinical evidence suggests similar caries-preventive efficacy of HVGIC and resin-based sealants after a period of 48 months in permanent molar teeth but remains challenged by high bias risk ; ( iii ) Evidence concerning a possible superiority of HVGIC above resin-based sealants after 60 months is poor ( even if the high bias risk is disregarded ) due to imprecision and requires corroboration through future research
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"Background This article constitutes a partial up date of the original systematic review evidence by Yengopal et al. from 15 January 2008 ( published in the Journal of Oral Science in 2009 ) with primary focus on research quality in regard to bias risk in trials . Its aim is to up date the existing systematic review evidence from the English literature as to whether caries occurrence on pits and fissures of teeth sealed with either GIC or resin is the same . Methods In addition to the 12 trials included during the original systematic review , 5 new trials were identified during the data base search ( up to 26 August 2010 ) and 2 further trials were included from a h and search and reference check . Of these , 3 trials were excluded and 16 were accepted for data extraction and quality assessment . The quality of accepted trials was assessed , using up date d quality criteria , and the risk of bias was investigated in more depth than previously reported . In addition , the focus of quantitative synthesis was shifted to single data sets that were extracted from the accepted trials . Results Twenty-six dichotomous and 4 continuous data sets were extracted . Meta- analysis and cumulative meta- analysis were used in combining clinical ly homogenous data sets . The overall outcome of the computed data sets suggest no difference between the caries-preventive effects of GIC- and resin-based fissure sealants . Conclusions This overall outcome is in agreement with the conclusions of the original systematic review . Although the findings of the trials identified in this up date may be considered to be less affected by attrition- and publication bias , their risk of selection - and detection-/performance bias is high . Thus , verification of the currently available results requires further high quality r and omised control trials",
"OBJECTIVES The aim of the present study was to investigate the caries-preventive effect of sealants produced with a high-viscosity glass-ionomer with an elevated powder-liquid ratio ( ART ) , of having energy added to this glass-ionomer , and that of glass-carbomer , in comparison to that of resin composite sealants . METHODS The r and omized controlled trial covered 407 children , with a mean age of 8 years . At a school compound three dentists placed sealants in pits and fissures of high caries-risk children . Evaluation by two independent evaluators was conducted after 0.5 , 1 and 2 years . The Kaplan-Meier survival method , ANOVA and t-test were used in analyzing the data . RESULTS 1352 first permanent molars were sealed . 6.6 % of children and 6.8 % of sealants dropped out within 2 years . 27 re-exposed pits and fissures , 20 in occlusal and 7 in smooth surfaces , in 25 children , developed a dentin carious lesion . The cumulative survival of dentin carious lesion-free pits and fissures in the glass-carbomer sealant group was statistically significantly lower ( 97.4 % ) than those in the high-viscosity glass-ionomer with energy supplied ( 99 % ) and the resin-composite ( 98.9 % ) sealant groups . There was no statistically significant difference in the cumulative survival of dentin carious lesion-free pits and fissures , between the high-viscosity glass-ionomer with ( 99 % ) and without ( 98.3 % ) energy supplied sealant groups , after 2 years . SIGNIFICANCE The survival of dentin carious lesion-free pits and fissures was high in all sealant types . More dentin carious lesions were observed in the glass-carbomer sealant group",
"Background R and omised controlled trials ( RCT ) are highly influential upon medical decisions . Thus RCTs must not distort the truth . One threat to internal trial validity is the correct prediction of future allocations ( selection bias ) . The Berger-Exner test detects such bias but has not been widely utilized in practice . One reason for this non-utilisation may be a lack of information regarding its test accuracy . The objective of this study is to assess the accuracy of the Berger-Exner test on the basis of relevant simulations for RCTs with dichotomous outcomes . Methods Simulated RCTs with various parameter setting s were generated , using R software , and subjected to bias-free and selection bias scenarios . The effect size inflation due to bias was quantified . The test was applied in both scenarios and the pooled sensitivity and specificity , with 95 % confidence intervals for alpha levels of 1 % , 5 % , and 20 % , were computed . Summary ROC curves were generated and the relationships of parameters with test accuracy were explored . Results An effect size inflation of 71 % - 99 % was established . Test sensitivity was 1.00 ( 95 % CI : 0.99 – 1.00 ) for alpha level 1 % , 5 % , and 20 % ; test specificity was 0.94 ( 95 % CI : 0.93 – 0.96 ) ; 0.82 ( 95 % CI : 0.80 – 0.84 ) , and 0.56 ( 95 % CI : 0.54 – 0.58 ) for alpha 1 % , 5 % , and 20 % , respectively . Test accuracy was best with the maximal procedure used with a maximum tolerated imbalance ( MTI ) = 2 as the r and omisation method at alpha 1 % . Conclusions The results of this simulation study suggest that the Berger-Exner test is generally accurate for identifying third-order selection bias",
"Background This article aims to up date the existing systematic review evidence elicited by Mickenautsch et al. up to 18 January 2008 ( published in the European Journal of Paediatric Dentistry in 2009 ) and addressing the review question of whether , in the same dentition and same cavity class , glass-ionomer cement ( GIC ) restored cavities show less recurrent carious lesions on cavity margins than cavities restored with amalgam . Methods The systematic literature search was extended beyond the original search date and a further h and - search and reference check was done . The quality of accepted trials was assessed , using up date d quality criteria , and the risk of bias was investigated in more depth than previously reported . In addition , the focus of quantitative synthesis was shifted to single data sets extracted from the accepted trials . Results The data base search ( up to 10 August 2010 ) identified 1 new trial , in addition to the 9 included in the original systematic review , and 11 further trials were included after a h and - search and reference check . Of these 21 trials , 11 were excluded and 10 were accepted for data extraction and quality assessment . Thirteen dichotomous data sets of primary outcomes and 4 data sets with secondary outcomes were extracted . Meta- analysis and cumulative meta- analysis were used in combining clinical ly homogenous data sets . The overall results of the computed data sets suggest that GIC has a higher caries-preventive effect than amalgam for restorations in permanent teeth . No difference was found for restorations in the primary dentition . Conclusion This outcome is in agreement with the conclusions of the original systematic review . Although the findings of the trials identified in this up date may be considered to be less affected by attrition- and publication bias , their risk of selection - and detection/performance bias is high . Thus , verification of the currently available results requires further high- quality r and omised control trials",
"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",
"Background The relative performance of ART sealant and fluoride-releasing resin sealant in preventing fissure caries in permanent molars was compared in a r and omized clinical trial conducted in southern China ( Clinical Trials.gov NCT01829334 ) . Methods After obtaining ethical approval , healthy schoolchildren who had permanent first molars with occlusal fissures which were sound but deep or presented with only incipient caries were recruited for the study . Included molars were r and omly allocated into one of four parallel study groups in units of left/right teeth per mouth . Two of the four groups adopted the methods of ART or fluoride-releasing resin sealant placement while the other two groups adopted the topical fluoride application methods . Fissure status of the molars in each group was evaluated every 6 months . Development of dentine caries and sealant retention over 24 months in the molars in the two sealant-using groups was compared in this report . Outcome on cost-effectiveness of all four groups over 36 months will be reported elsewhere . Results At baseline , a total of 280 children ( 383 molars ) with mean age 7.8 years were involved for the two sealant groups . After 24 months , 261 children ( 357 molars ) were followed . Proportions of molars with dentine caries were 7.3 % and 3.9 % in the ART sealant and fluoride-releasing resin sealant groups , respectively ( chi-square test , p = 0.171 ) . Life-table survival analysis showed that sealant retention ( full and partial ) rate over 24 months for the resin sealant ( 73 % ) was significantly higher than that ( 50 % ) for the ART sealant ( p Molar survival ( no development of dentine caries ) rates in the ART sealant ( 93 % ) and fluoride-releasing resin sealant ( 96 % ) groups were not significantly different ( p = 0.169 ) . Multilevel logistic regression ( GEE modeling ) accounting for the effects of data clustering and confounding factors confirmed this finding . Conclusions Though the retention of fluoride-releasing resin sealant was better than that of the ART sealant , their effectiveness in preventing fissure caries in permanent molars did not differ significantly over 24 months . ART sealants could be a good alternative when and where re sources for resin sealant placement are not readily available",
"Background Naïve-indirect comparisons are comparisons between competing clinical interventions ’ evidence from separate ( uncontrolled ) trials . Direct comparisons are comparisons within r and omised control trials ( RCTs ) . The objective of this empirical study is to test the None-hypothesis that trends and performance differences inferred from naïve-indirect comparisons and from direct comparisons/ RCTs regarding the failure rates of amalgam and direct high-viscosity glass-ionomer cement ( HVGIC ) restorations in permanent posterior teeth have similar direction and magnitude . Methods A total of 896 citations were identified through systematic literature search . From these , ten and two uncontrolled clinical longitudinal studies for HVGIC and amalgam , respectively , were included for naïve-indirect comparison and could be matched with three out twenty RCTs . Summary effects sizes were computed as Odds ratios ( OR ; 95 % Confidence intervals ) and compared with those from RCTs . Trend directions were inferred from 95 % Confidence interval overlaps and direction of point estimates ; magnitudes of performance differences were inferred from the median point estimates ( OR ) with 25 % and 75 % percentile range , for both types of comparison . Mann-Whitney U test was applied to test for statistically significant differences between point estimates of both comparison types . Results Trends and performance differences inferred from naïve-indirect comparison based on evidence from uncontrolled clinical longitudinal studies and from direct comparisons based on RCT evidence are not the same . The distributions of the point estimates differed significantly for both comparison types ( Mann – Whitney U = 25 , nindirect = 26 ; ndirect = 8 ; p = 0.0013 , two-tailed ) . Conclusion The None-hypothesis was rejected . Trends and performance differences inferred from either comparison between HVGIC and amalgam restorations failure rates in permanent posterior teeth are not the same . It is recommended that clinical practice guidance regarding HVGICs should rest on direct comparisons via RCTs and not on naïve-indirect comparisons based on uncontrolled longitudinal studies in order to avoid inflation of effect estimates",
"A double-blind r and omized clinical trial was performed in 6- to 7-yr-old schoolchildren to evaluate , in a 30-mo period , whether the caries increment on the distal surface of the second primary molars adjacent to permanent first molars sealed with fluoride release compounds would be lower with respect to those adjacent to permanent first molars sealed with a nonfluori date d sealant . In sum , 2,776 subjects were enrolled and r and omly divided into 3 groups receiving sealants on sound first molars : high-viscosity glass ionomer cement ( GIC group ) ; resin-based sealant with fluoride ( fluoride-RB group ) ; and a resin-based sealant without fluoride ( RB group ) . Caries ( D1 – D3 level ) was recorded on the distal surface of the second primary molar , considered the unit of analysis including only sound surfaces at the baseline . At baseline , no differences in caries prevalence were recorded in the 3 groups regarding the considered surfaces . At follow-up , the prevalence of an affected unit of analysis was statistically lower ( p = .03 ) in the GIC and fluoride-RB groups ( p = .04 ) . In the GIC group , fewer new caries were observed in the unit of analysis respect to the other 2 groups . Incidence rate ratios ( IRRs ) were 0.70 ( 95 % confidence interval : 0.50 , 0.68 ; p Caries incidence was significantly associated with low socioeconomic status ( IRR = 1.18 ; 95 % confidence interval : 1.10 , 1.42 ; p = .05 ) . Dental sealant high-viscosity GIC and fluoride-RB demonstrated protection against dental caries , and there was evidence that these material s afforded additional protection for the tooth nearest to the sealed tooth ( clinical trial registration NCT01588210 )",
"To investigate the effectiveness of 3 caries-preventive measures on high– and low – caries risk occlusal surfaces of first permanent molars over 3 y. This cluster-r and omized controlled clinical trial covered 242 schoolchildren , 6 to 7 y old , from low socioeconomic areas . At baseline , caries risk was assessed at the tooth surface level , through a combination of ICDAS II ( International Caries Detection and Assessment System ) and fissure depth codes . High – caries risk occlusal surfaces were treated according to daily supervised toothbrushing ( STB ) at school and 2 sealants : composite resin ( CR ) and atraumatic restorative treatment – high-viscosity glass-ionomer cement ( ART-GIC ) . Low – caries risk occlusal surfaces received STB or no intervention . Evaluations were performed after 0.5 , 1 , 2 , and 3 y. A cavitated dentine carious lesion was considered a failure . Data were analyzed according to the proportional hazard rate regression model with frailty correction , Wald test , analysis of variance , and t test , according to the jackknife procedure for calculating st and ard errors . The cumulative survival rates of cavitated dentine carious lesion – free , high – caries risk occlusal surfaces were 95.6 % , 91.4 % , and 90.2 % for STB , CR , and ART-GIC , respectively , over 3 y , which were not statistically significantly different . For low – caries risk occlusal surfaces , no statistically significant difference was observed between the cumulative survival rate of the STB group ( 94.8 % ) and the no-intervention group ( 92.1 % ) over 3 y. There was neither a difference among STB , CR , and ART-GIC on school premises in preventing cavitated dentine carious lesions in high – caries risk occlusal surfaces of first permanent molars nor a difference between STB and no intervention for low – caries risk occlusal surfaces of first permanent molars over 3",
"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 This study 's purpose was to evaluate the caries-preventive effect of a glass ionomer cement ( GIC ) used as an occlusal sealant on recently erupted permanent first molars . METHODS A double-blind , r and omized , controlled , clinical trial was undertaken that included 36 5- to 8-year-olds ( and 92 permanent first molars ) who were r and omly allocated to the test group ( GIC ) or the control group ( auto-polymerized resin-based sealant [ RBS ] ) . The Mann-Whitney test was used to compare the number of new carious or filled occlusal surfaces in the 2 groups . RESULTS After 6 months , 1 occlusal surface in the test group and 2 occlusal surfaces in the control group showed carious lesions ( P=.15 ) . In the fifth year of follow-up , 2 occlusal surfaces in the test group and 7 occlusal surfaces in the control group were filled or carious ( P=.42 ) , and the mean number of sealed surfaces that became carious or filled was 0.2 ( 95 % confidence interval [CI]=0.02 - 0.70 ) for the GIC-sealed teeth and 0.6 ( 95 % CI=0.20 - 1.30 ) for the RBS-sealed teeth ( P=.30 ) . CONCLUSION High-viscosity glass ionomer cement can provide some level of protection against dental caries when used as a dental sealant in newly erupted permanent first molars",
"OBJECTIVE The hypotheses tested were : the cumulative survival rates of dentin caries lesion-free pits and fissures of ART conventional high-viscosity glass-ionomer sealants with light-curing ( high-intensity LED ) and glass-carbomer sealants are higher than those of conventional ART sealants and resin-composite sealants after 4 years . METHODS The r and omized controlled clinical trial covered 405 children ( mean age 8-years ) . Three dentists placed sealants in pits and fissures of high caries-risk children . Evaluation by two independent evaluators was conducted after 0.5 , 1 , 2 , 3 and 4 years . The Kaplan-Meier survival method , ANOVA and t-test were used in data analyses . RESULTS 1304 first permanent molars were sealed . 12.3 % of children and 15.4 % of sealants dropped out . 46 re-exposed pits and fissures , 39 ( occlusal ) 7 ( free smooth surfaces ) , in 42 children developed a dentin carious lesion . The cumulative survival of dentin caries lesion-free occlusal pits and fissures in ART plus LED group ( 98 % ) was statistically significantly higher than in the resin-composite group ( 96.4 % ) and in the glass-carbomer group ( 94.5 % ) . The cumulative survival of dentin caries lesion-free occlusal pits and fissures in the glass-carbomer group was statistically significantly lower than that in the conventional ART group ( 97.3 % ) . For the free smooth surfaces , there was no statistically significantly difference among the four sealant groups . SIGNIFICANCE Light-cured ART conventional high-viscosity glass-ionomer sealants prevented the occurrence of dentin cavities best"
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Chronic pain complaints after thoracic surgery represent a significant clinical problem in 25 - 60 % of patients . Results from thoracic and other surgical procedures suggest multiple pathogenic mechanisms that include pre- , intra- , and postoperative factors . This review attempts to analyse the methodology and systematic s of the studies on the post-thoracotomy pain syndrome ( PTPS ) after lung cancer surgery in adults , in order to clarify the relative role of possible pathogenic factors and to define future strategies for prevention . Literature published from 2000 to 2008 together with studies included in previous systematic review s was search ed recursively using PubMed and OVID by combining three categories of search terms . The available data have major inconsistencies in collection of pre- , intra- and postoperative data that may influence PTPS , thereby hindering precise conclusions as well as preventive and treatment strategies . However , intercostal nerve injury seems to be the most important pathogenic factor . Since there is a general agreement on the clinical relevance of PTPS , a proposal for design of future trials is presented
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"Fifty patients undergoing thoracotomy was studied to compare the effects of cryoanalgesia combined with intravenous continuous analgesia ( IVCA ) . Patients were r and omized into two groups : IVCA group and IVCA-cryo group . Subjective pain intensity was assessed on a visual analogue scale at rest ( VAS-R ) and during movement ( VAS-M ) . Analgesic requirements were evaluated over the 7 days following surgery . Forced vital capacity ( FVC ) and forced expiratory volume in 1 sec ( FEV1 ) were measured before operation , on the 2nd and 7th postoperative days ( POD ) . We interviewed patients by telephone to evaluate the prevalence of post-thoracotomy pain at the 1st , 3rd , and 6th months postoperatively . No significant differences were observed between the two groups with respect to postoperative pain , analgesic requirements , side effects , respiratory complications , or prevalence of post-thoracotomy pain . However , a significant increase in FVC and FEV1 was observed on the 7th POD in IVCAc-ryo group . The incidence of the post-thoracotomy pain at the 1st , 3rd , and 6th months postoperatively was 68 , 60 , and 44 % in IVCA group , and 88 , 68 , and 28 % in IVCA-cryo group , respectively . Our study showed that cryoanalgesia combined with IVCA effectively restore respiratory function on 7th POD , but that it was not effective at reducing the incidence of post-thoracotomy pain",
"Background Despite major advances in the underst and ing of the neurobiologic mechanisms of pain , the wide variation in acute pain experience has not been well explained . Therefore , the authors investigated the potential of a preoperatively induced heat injury to predict subsequent postoperative pain ratings in patients undergoing knee surgery . Methods Twenty patients were studied . The burn injury was induced 6 days before surgery with a contact thermode ( 12.5 cm2 , 47 ° C for 7 min ) . The sensory testing , before and 1 h after the injury , included pain score during induction of the burn , secondary hyperalgesia area , thermal and mechanical pain perception , and pain thresholds . Postoperative analgesia consisted of ibuprofen and acetaminophen . Pain ratings ( visual analog scale ) at rest and during limb movement were followed for 10 days after surgery . Results The burn injury was associated with development of significant hyperalgesia . There was a significant correlation between preoperative pain ratings during the burn injury and early ( 0–2 days , area under the curve ) and late ( 3–10 days , area under the curve ) postoperative dynamic pain ratings during limb movement . Conclusion The results of this study suggest that the pain response to a preoperative heat injury may be useful in research in predicting the intensity of postoperative pain . These findings may have important implication s to identify patients at risk for development of chronic pain and to stratify individuals for investigations of new analgesics",
"Background : Ketamine potentiates intravenous or epidural morphine analgesia . The authors hypothesized that very-low-dose ketamine infusion reduces acute and long-term postthoracotomy pain . Methods : Forty-nine patients scheduled to undergo open thoracotomy were r and omly assigned to receive one of two anesthesia regimens : continuous epidural infusion of ropivacaine and morphine , along with intravenous infusion of ketamine ( 0.05 mg · kg−1 · h−1 [ approximately 3 mg/h ] , ketamine group , n = 24 ) or placebo ( saline , control group , n = 25 ) . Epidural analgesia was continued for 2 days after surgery , and infusion of ketamine or placebo was continued for 3 days . Pain was assessed at 6 , 12 , 24 , and 48 h after surgery . Patients were asked about their pain , abnormal sensation on the wound , and inconvenience in daily life at 7 days and 1 , 3 , and 6 months after surgery . Results : The visual analog scale scores for pain at rest and on coughing 24 and 48 h after thoracotomy were lower in the ketamine group than in the control group ( pain at rest , 9 ± 11 vs. 25 ± 20 and 9 ± 11 vs. 18 ± 13 ; pain on coughing , 26 ± 16 vs. 50 ± 17 and 30 ± 18 vs. 43 ± 18 , mean ± SD ; P = 0.002 and P = 0.01 , P . The numerical rating scale scores for baseline pain 1 and 3 months after thoracotomy were significantly lower in the ketamine group ( 0.5 [ 0–4 ] vs. 2 [ 0–5 ] and 0 [ 0–5 ] vs. 1.5 [ 0–6 ] , median [ range ] , respectively ; P = 0.02 ) . Three months after surgery , a higher number of control patients were taking pain medication ( 2 vs. 9 ; P = 0.03 ) . Conclusions : Very-low-dose ketamine ( 0.05 mg · kg−1 · h−1 ) potentiated morphine-ropivacaine analgesia and reduced postthoracotomy pain ",
"Background : Women scheduled to undergo hysterectomy for benign indications frequently have preoperative pelvic pain , but it is largely unknown why pain in some cases persists or even develops after surgery . This nationwide question naire and data base study describes pain and identifies risk factors for chronic postsurgical pain 1 yr after hysterectomy for benign indications . Methods : A pain question naire was mailed to 1,299 women 1 yr after hysterectomy . The response rate was 90.3 % , and the presence of persistent pain was correlated to indication for surgery , surgical procedure , type of anesthesia , and other perioperative data . Results : Pain was reported by 31.9 % 1 yr after hysterectomy ( chronic pain ) , and 13.7 % had pain more than 2 days a week . Pain was not present before surgery in 14.9 % of women with chronic postsurgical pain . Risk factors for chronic pain were preoperative pelvic pain ( odds ratio [ OR ] , 3.25 ; 95 % confidence interval [ CI ] , 2.40–4.41 ) , previous cesarean delivery ( OR , 1.54 ; CI , 1.06–2.26 ) , pain as the main indication for surgery ( OR , 2.98 ; CI , 1.54–5.77 ) , and pain problems elsewhere ( OR , 3.19 ; CI , 2.29–4.44 ) . Vaginal hysterectomy versus total abdominal hysterectomy was not significantly associated with a lower risk of chronic pain ( OR , 0.70 ; CI , 0.46–1.06 ) . Importantly , spinal versus general anesthesia was associated with less chronic pain ( OR , 0.42 ; CI , 0.21–0.85 ) . Conclusions : Thirty-two percent had chronic pain after hysterectomy , and risk factors were comparable to those seen in other operations . Interestingly , spinal anesthesia was associated with a lower frequency of chronic pain , justifying prospect i ve study of spinal anesthesia for patients with a high risk for development of chronic postsurgical pain",
"In this clinical , r and omized , prospect i ve study , we compared the effects of three different analgesia techniques ( thoracic epidural analgesia [ TEA ] with and without preoperative initiation and IV patient-controlled analgesia [ IV-PCA ] ) on postthoracotomy pain in 69 patients . In two groups , a thoracic epidural catheter was inserted preoperatively . Group Pre-TEA had bupivacaine and morphine solution preoperatively and intraoperatively . Postoperative analgesia was maintained with epidural PCA with a similar solution . Group Post-TEA , with no intraoperative medication , had the same postoperative analgesia as Group Pre-TEA plus the bolus dose . Group IV-PCA received only IV-PCA with morphine for postoperative analgesia . Pain was evaluated every 4 h during the first 48 h at rest , cough , and movement . Pre-TEA was associated with decreased pain compared with the other groups . Six months later , the patients were asked about their pain . The incidence and the intensity of pain were most frequent in Group IV-PCA ( 78 % ) and were the least in Group Pre-TEA ( 45 % ) ( Group Pre-TEA versus Group IV-PCA , P = 0.0233 ; Group Pre-TEA versus Group IV-PCA , P = 0.014 ) . Patients having pain on the second postoperative day had 83 % chronic pain . TEA with preoperative initiation is a preferable method in preventing acute and long-term thoracotomy pain",
"BACKGROUND Thoracotomy is associated with significant pain and morbidity . METHODS We performed a prospect i ve r and omized trial over 4 months . Patients were r and omized to a st and ard posterior-lateral thoracotomy or an identical procedure , except an intercostal muscle was harvested from the lower rib ( to protect the intercostal nerve ) before chest retraction . To ensure an equal distribution among both groups , patients were stratified by race , sex , and type of pulmonary resection . All patients received similar pain management . Pain was assessed by using multiple pain scores during hospitalization and after discharge . Outcomes assessed were pain scores , spirometric values , analgesic use , and activity level . RESULTS There were 114 patients . The median time for intercostal muscle harvesting was 3.7 minutes . The numeric pain scores were lower for the intercostal muscle group on postoperative days 1 and 2 and at weeks 1 , 2 , 3 , 4 , 8 , and 12 ( P spirometric values , were less likely to be using analgesics , and were more likely to have returned to normal activity . CONCLUSIONS The harvesting of an intercostal muscle flap before chest retraction decreases the pain of thoracotomy and leads to a lower decrease in spirometry . In addition , patients have less pain at 1 , 2 , 3 , 4 , 8 , and 12 weeks postoperatively and are less likely to be using narcotics . Finally , it offers a pedicled muscle flap that takes little time to harvest and is able to buttress all bronchi after lobectomy",
"OBJECTIVE Long-term pain is a common sequela of thoracotomy , occurring in approximately 50 % of patients 2 years after thoracic surgery . Despite this alarming statistic , little is known about the factors responsible for the transition of acute to chronic pain . The aim of the present study is to identify predictors of long-term post-thoracotomy pain . DESIGN Follow-up was for 1.5 years for patients who had participated in a prospect i ve , r and omized , controlled trial of preemptive , multimodal analgesia . SETTING Subjects were recruited from a tertiary care center . PATIENTS Thirty patients who had undergone lateral thoracotomy were followed up by telephone , administered a structured interview , and classified according to long-term pain status . MAIN OUTCOME MEASURES Present pain status was measured by a verbal rating scale ( VAS ) . Measures obtained within the first 48 h after surgery were compared between patients with and without pain 1.5 years later . These include VAS pain scores at rest and after movement , McGill Pain Question naire data , patient-controlled morphine consumption ( mg ) , and pain thresholds to pressure applied to a rib contralateral to the thoracotomy incision . RESULTS Fifty-two percent of patients reported long-term pain . Early postoperative pain was the only factor that significantly predicted long-term pain . Pain intensity 24 h after surgery , at rest , and after movement was significantly greater among patients who developed long-term pain compared with pain-free patients . A significant predictive relationship was also found at 24 and 48 h using the McGill Pain Question naire . Cumulative morphine was comparable for the two groups . Pain thresholds to pressure applied to a rib contralateral to the incision did not differ significantly between the groups . CONCLUSION Aggressive management of early postoperative pain may reduce the likelihood of long-term post-thoracotomy pain",
"Thoracotomy causes severe postoperative pain , which is difficult to manage since the use of systemic analgesics often causes respiratory depression . Cryoanalgesia of the intercostal nerves has been advocated as an effective means of local analgesia without serious side effects . A prospect i ve r and omised blind trial to investigate the efficacy of the technique was carried out . A total of 53 patients undergoing thoracotomy were allocated to either the trial or a control group . At thoracotomy the surgeon was informed of the patient 's trial allocation . The trial group received one minute of direct cryotherapy to at least five intercostal nerves related to the incision . All patients received methadone via the lumbar epidural route in a dose calculated according to their weight . A linear analogue assessment of postoperative pain was made by the patients as soon as they were sufficiently awake . An independent record of all postoperative analgesia was kept . After discharge from hospital further assessment s were made at least six weeks after operation . Statistical analysis of the scores of postoperative pain and analgesic consumption showed that there was no significant difference between the trial and the control group . There was , however , a suggestion of an increase in the long term morbidity , although these figures were not amenable to statistical analysis . Thus is has not been possible to demonstrate a role for cryoanalgesia in the control of post thoracotomy pain",
"Epidural analgesia is regarded as the gold method for controlling post‐thoracotomy pain . Intercostal nerve cryoanalgesia can also produce satisfactory analgesic effects , but is suspected to increase the incidence of chronic pain . However , r and omized controlled trials comparing these two methods for post‐thoracotomy acute pain analgesic effects and chronic pain incidents have not been conducted previously . We studied 107 adult patients , allocated r and omly to thoracic epidural bupivacaine and morphine or intercostal nerve cryoanalgesia . Acute pain scores and opioid‐related side effects were evaluated for three postoperative days . Chronic pain information , including the incidence , severity , and allodynia‐like pain , was acquired on the first , third , sixth and twelfth months postoperatively . There was no significant difference on numeral rating scales ( NRS ) at rest or on motion between the two groups during the three postoperative days . The patient satisfaction results were also similar between the groups . The side effects , especially mild pruritus , were reported more often in the epidural group . Both groups showed high incidence of chronic pain ( 42.1–72.1 % ) , and no significance between the groups . The incidence of allodynia‐like pain reported in cryo group was higher than that in Epidural group on any postoperative month , with significance on the sixth and the twelfth months postoperatively ( P their chronic pain intensity on moderate and severe in cryo group and interfered with daily life ( P satisfactory analgesia for post‐thoracotomy acute pain . The incidence of post‐thoracotomy chronic pain is high . Cryoanalgesia may be a factor that increases the incidence of neuropathic pain",
"Purpose To examine the effect of continuous epidural block initiated before thoracic surgery upon early and long-term postoperative pain . Methods In a double-blind study , 70 patients scheduled for thoracic surgery under general anesthesia were assigned r and omly to receive continuous epidural block with mepivacaine 1.5 % initiated either 20 min before surgical incision ( Pre group ) or at completion of surgery ( Post group ) . In both groups the initial dose was 4 ml , followed by a continuous infusion at 4 ml·hr−1 until 72 hr after operation . Indomethadn suppositories , 50 mg , were administered on request as supplementary analgesics . Visual analogue scale at rest was assessed four hours after operation , and then every 24 hr after operation on postoperative days 1 through 7 , and also days 14 and 30 . At three and six months after operation , all patients were interviewed by telephone with respect to postoperative pain . The most severe pain was assessed using modified numerical rating scale . Results By a visual analogue scale , postoperative pain was less in the Pre group than in the Post group at four hours , two and three days after operation ( P numerical rating scale six months after operation , pain was less in the Pre group than in the Post group ( P = 0.015 ) . The percentage of pain-free patients was higher in the Pre group than in the Post group at three ( P = 0.035 ) and six ( P = 0.0086 ) months after operation . Conclusion Continuous epidural block initiated prior to surgery may reduce long-term post-thoracotomy pain . RésuméObjectifExaminer l’effet d’un blocage épidural continu , amorcé avant une intervention chirurgicale thoracique , sur la douleur postopératoire précoce et de long terme . MéthodeLétude à double insu a porté sur 70 patients qui devaient subir une opération thoracique sous anesthésie générale . Répartis au hasard , ils ont reçu un blocage épidural continu avec de la mépivacaïne à 1,5 % , administrée soit 20 min avant l’incision chirurgicale ( groupe Pré ) , soit à la fin de l’intervention ( groupe Post ) . Pour tous , la dose initiale a été de 4 ml suivie d’une perfusion continue à 4 ml·hr−1 jusqu’à 72 h après l’opération . Des suppositoires de 50 mg d’indométhacine ont été administrés sur dem and e pour compléter l’analgésie . La douleur a été évaluée au repos selon l’échelle visuelle analogique , 4 h après l’opération et puis à toutes les 24 h des jours 1 à 7 et aussi les jours 14 et 30 . Trois mois et six mois après l’opération , tous les patients ont été interrogés par téléphone au sujet de la douleur postopératoire . La douleur la plus sévère a été évaluée en utilisant une échelle d’estimation numérique modifiée . RésultatsSelon l’échelle visuelle analogique , la douleur postopératoire était plus faible chez les patients du groupe Pré que chez ceux du groupe Post à 4 h , deux et trois jours après l’opération ( P pourcentage de patients sans douleur était plus élevé dans le groupe Pré que dans le groupe Post à trois mois ( P = 0,035 ) et à six mois ( P = 0,0086 ) après l’opération . Conclusion Le blocage épidural continu amorcé avant l’intervention chirurgicale peut réduire la douleur qui se prolonge après une thoracotomie",
"BACKGROUND In this study we have evaluated the efficacy of ketamine via i.m . and epidural routes for the control of post-thoracotomy pain . METHODS The study was r and omized , double blinded and placebo controlled . With the approval of the Faculty Ethics Committee , 60 patients undergoing elective thoracotomy were r and omized into three equal groups . Group IM had i.m . ketamine 1 mg kg(-1 ) in 2 ml plus epidural normal saline ; Group EPI had epidural ketamine 1 mg kg(-1 ) in 10 ml plus i.m . normal saline ; Group C had epidural normal saline 10 ml plus i.m . normal saline 10 ml . Anaesthesia was st and ardized . Postoperative analgesia was maintained with epidural patient-controlled analgesia using bupivacaine and morphine . Visual analogue scale values and analgesic consumption were evaluated at 2 , 4 , 6 , 8 , 10 , 12 , 24 and 48 h after surgery . The areas of allodynia , pin-prick hyperalgesia and pressure hyperalgesia were measured at 48 h , and days 15 and 30 in all groups . RESULTS Intraoperative fentanyl requirement was significantly lower in Group EPI than Group C. The morphine and bupivacaine requirements were significantly lower in Group EPI than the other two groups in the postoperative period . There was reduced pin-prick hyperalgesia and touch allodynia in the EPI group . There were no side-effects attributable to ketamine . CONCLUSION The results of the present study demonstrate that pre-emptive epidural ketamine is effective in reducing intra- and postoperative analgesic requirements , hyperalgesia and touch allodynia",
"OBJECTIVE Our aim was to investigate the prevalence of intra-operative nerve damage and its association with chronic pain . METHODS Our prospect i ve study of 33 patients used nerve conduction studies to assess intercostal nerve function during elective thoracic surgical procedures . We used two methods to study nerve conduction : pre-operative magnetic stimulation ( in 10 patients ) and intra-operative nerve conduction studies ( in all patients ) We correlated these findings with specific intra-operative parameters , pain and psychological question naires pre-op and 3 month post-op and altered cutaneous sensation . RESULTS Magstim ( magnetic stimulation ) assessment s were not reliable and were therefore ab and oned . Intraoperative intercostal nerve studies revealed two distinct patterns of nerve injury and also that nerve injury was less in those cases where a rib was not resected . However , intercostal nerve damage detected at the time of operation is not associated with chronic pain or altered cutaneous sensation at 3 months post-op . CONCLUSIONS The study findings suggest that either the amount of intra-operative intercostal nerve damage is not indicative of long-term nerve damage or that there is a more significant cause for chronic pain other than intercostal nerve injury",
"Background Pain following thoracotomy can persist for years with an undetermined impact on quality of life . Factors hypothesized to modulate this painful experience include analgesic regimen , gender , and type of incision . Methods A total of 157 generally healthy patients of both genders scheduled for segmentectomy , lobectomy , or bilobectomy through a posterolateral or muscle-sparing incision were r and omly assigned to receive thoracic epidural analgesia initiated prior to incision or at the time of rib approximation . Pain and activity scores were obtained 4 , 8 , 12 , 24 , 36 , and 48 weeks after surgery . Results Overall , there were no differences in pain scores between the control and intervention groups during hospitalization ( P ≥ 0.165 ) or after discharge ( P ≥ 0.098 ) . The number of patients reporting pain 1 yr following surgery ( 18 of 85 ; 21.2 % ) was not significantly different ( P = 0.122 ) from the number reporting preoperative pain ( 15 of 120 ; 12.5 % ) . During hospitalization , women reported greater pain than men ( worst pain , P = 0.007 ; average pain , P = 0.016 ) . Women experienced fewer supraventricular tachydysrhythmias ( P = 0.013 ) and were thus discharged earlier ( P = 0.002 ) . After discharge women continued to report greater discomfort than men ( P ≤ 0.016 ) , but did not differ from men in their level of physical activity ( P = 0.241 ) . Conclusions Initiation of thoracic epidural analgesia prior to incision or the use of a muscle-sparing incision did not significantly impact pain or physical activity . Although women reported significantly greater pain during hospitalization and after discharge , they experienced fewer complications , were more likely to be discharged from the hospital sooner , and were just as active after discharge as men",
"STUDY OBJECTIVES We set out to determine whether there is a difference in postoperative pain and recovery after the patient undergoes the axillary muscle-sparing incision ( ie , muscle-sparing thoracotomy [ MT ] ) vs the modified posterolateral incision ( ie , posterolateral thoracotomy [ PT ] ) . DESIGN Analysis of a data base originally collected to determine the effect of the timing of epidural analgesia on long-term outcome after thoracotomy . SETTING The Hospital of the University of Pennsylvania . PATIENTS Patients presenting for lobectomy , segmentectomy , or bilobectomy . MEASUREMENTS Pain , physical activity , and the extent that pain interfered with activities following major thoracotomy were prospect ively assessed with st and ard question naires ( ie , the brief pain inventory and the Medical Outcomes Study 36-item short form ) on postoperative days 1 to 5 , and at postoperative weeks 4 , 8 , 12 , 24 , 36 , and 48 by a blinded research assistant . Perioperative care was st and ardized and included patient-controlled thoracic epidural analgesia until thoracostomy tube removal . RESULTS Eighty-two subjects underwent MT and 38 subjects underwent PT during the 16-month accrual period . There were no significant differences in demographics . Pain reported during hospitalization and after hospital discharge did not differ with respect to incision type ( p > or = 0.17 ) . Postoperative physical activity levels were significantly less than those reported preoperatively , with a trend toward better functioning in the MT groups after 8 weeks . Incision type did not predict complications , morbidity , or mortality . CONCLUSIONS When comparing patients who had undergone vertical , axillary , wholly MT to those who had undergone modified serratus muscle-sparing PT , postoperative differences in pain were not apparent . One should not anticipate reduced pain or more rapid overall recovery following MT , at least when epidural analgesia is used aggressively for perioperative pain control",
"Background : Treatment of post‐operative pain is still a significant problem . Recently , interest has focused on pre‐operative identification of patients who may experience severe post‐operative pain in order to offer a more aggressive analgesic treatment . The nociceptive stimulation methods have included heat injury and pressure algometry . A simple method , Pain Matcher ® ( PM ) , using electrical stimulation , is vali date d for pain assessment , but has not been evaluated as a tool for prediction of post‐operative pain . Our aim was to assess the predictive value of pre‐caesarean section pain threshold on intensity of post‐caesarean section pain using the PM",
"Our objective was to evaluate the usefulness , safety , validity and benefits of video-assisted thoracoscopic surgery ( VATS ) for performing pulmonary lobectomy in 24 patients with clinical NO stage I primary non-small-cell lung cancer compared with 30 patients who underwent a conventional thoracotomy . There were no significant differences in the intra-operative blood loss , duration of operation , or duration of chest tube drainage between the VATS group and the st and ard lobectomy group , but in this VATS ' experience , patients had less postoperative pain . Numbers and distributions of dissected lymph-nodes were similar in patients whether undergoing st and ard thoracotomy or VATS lobectomy . We can confirm that the safety and validity of VATS are virtually identical to those of the st and ard thoracotomy approach in the lobectomy . However , the former technique causes less discomfort to patients and requires a shorter recovery period of laboratory data and IL-6 concentrations in thoracic drainage fluid . We conclude that VATS major lung resection is technically feasible . Stringent patient selection is important and special training is needed",
"Recent evidence suggests that surgical trauma induces a process of central nervous system sensitisation that contributes to and enhances postoperative pain . These changes are also thought to be the underlying cause of much chronic pain . Central sensitisation is generated not only during surgery , but also postoperatively as a result of the inflammatory response to the damaged tissue . This knowledge provides a rational basis for pro-active , pre-emptive and postoperative analgesic strategies to reduce the neuronal barrage associated with tissue damage . Reduction or elimination of postoperative pain is therefore possible . We advocate the use of continuous extrapleural intercostal nerve block for postoperative analgesia in patients undergoing thoracotomy . When this is begun pre-emptively ( by precutaneous , pre-incisional paravertebral block ) it is combined with an opiate and a non-steroidal anti-inflammatory drug premedication . In a r and omised study of 56 patients , pain scores of less than 0.5 cm on a 10 cm scale were produced , postoperative lung function was preserved and glucose and cortisol responses were significantly unchanged from preoperative values . Evidence that effective perioperative analgesia reduces the incidence of chronic post-thoracotomy chest wall pain was found in a retrospective study of 1000 consecutive thoracotomies . The endpoints of a zero pain score , complete preservation of preoperative lung function and prevention of the stress response to trauma are currently achievable and should be provided for virtually all patients undergoing chest surgery . Pre-empting pain must be the goal for all those involved in the postoperative care of patients",
"OBJECTIVE Although the thoracotomy incision is guided in part by the exposure required , both cosmesis and the potential for improved recovery are important factors to be taken into account . We conducted a prospect i ve r and omized study in order to compare muscle sparing thoracotomy ( MST ) and st and ard posterolateral thoracotomy ( PLT ) for postoperative pain and physical function during and after hospitalization . MATERIAL AND METHOD One hundred patients operated from June through December 2004 were recruited in this study . Fifty patients underwent MST of 6 - 8 cm and 50 had a PLT of more than 8 cm with division of latissimus dorsi and serratus anterior muscles . Operations performed were atypical resections and lobectomies . Pneumonectomies and operations on tumors invading the chest wall or brachial plexus were excluded . Perioperative care was st and ardized concerning analgetics and physiotherapy . Postoperative pain ( quantitated by the visual analogue scale ) , preoperative and postoperative pulmonary function , shoulder strength , and range of motion were evaluated . RESULTS There was no difference in demographics , tumor stage , and type of lung resection . Patients were also matched for the number of chest tubes , length of chest tube duration , and length of hospital stay . Pain reported during hospitalization and after hospital discharge within 1 and 2 months did not differ within the two groups ( p>0.05 ) . Shoulder function was shown to decrease less in cases of MST , but physical function was not found statistically significant in comparison of the two groups ( p>0.05 ) within 1 month . Rehabilitation was also similar . CONCLUSION The rates of occurrence of acute or chronic pain and morbidity were equivalent after MST and PLT . It appears that the single advantage of MST over PLT involves the preservation of chest wall musculature in case rotational muscle flaps should be needed along with a better cosmetic result",
"Background : Pain after amputation is common but difficult to treat . Therefore , the authors examined whether postoperative treatment with gabapentin could reduce postamputation stump and phantom pain . Methods : Forty-six patients scheduled to undergo lower limb amputation were r and omly assigned to receive oral gabapentin or placebo . Treatment was started on the first postoperative day and continued for 30 days . The daily dose of gabapentin or placebo was gradually increased to 2,400 mg/day . The intensity of stump and phantom pain was recorded every day on a numeric rating scale ( 0–10 ) during the 30-day treatment period . Five interviews were performed after 7 , 14 , and 30 days and after 3 and 6 months . Results : Results from 41 patients were included in the data analysis . The risk of phantom pain ( gabapentin vs. placebo ) was 55.0 % versus 52.6 % ( risk difference , 2.4 % ; 95 % confidence interval , −28.9 to 33.7 % ; P = 0.88 ; 30 days ) and 58.8 % versus 50.0 % ( risk difference , 8.8 % ; 95 % confidence interval , −23.3 to 40.9 % ; P = 0.59 ; 6 months ) . The median intensity of phantom pain ( gabapentin vs. placebo ) was 1.5 ( range , 0–9.0 ) versus 1.2 ( range , 0–6.6 ) ( P = 0.60 ; 30 days ) and 1.0 ( range , 0–6.0 ) versus 0.5 ( range , 0–5.0 ) ( P = 0.77 ; 6 months ) . The median intensity of stump pain was 0.85 ( range , 0–8.2 ) versus 1.0 ( range , 0–5.4 ) ( P = 0.68 ; 30 days ) and 0 ( range , 0–8.0 ) versus 0 ( range , 0–5.0 ) ( P = 0.58 ; 6 months ) . Conclusion : Gabapentin administered in the first 30 postoperative days after amputation does not reduce the incidence or intensity of postamputation pain",
"Abstract The significance of preamputation pain for the development of postamputation stump and phantom pain has been discussed over the years and is still a matter of dispute . It has been argued that preamputation pain increases the risk of phantom pain and that phantom pain is a revivification of pain experienced before the amputation . The purpose of this prospect i ve study was to clarify the relation between preamputation pain and phantom pain . Fifty‐six patients scheduled for amputation of a lower limb were interviewed the day before the amputation about preamputation pain and about stump and phantom pain 1 week , 3 and 6 months after the amputation . Pain was quantitated and described using a visual analogue scale ( VAS ) , 10 different word descriptors , the McGill Pain Question naire ( MPQ ) and the patients ' own words . If phantom pain was present patients were asked if the pain was similar to any pain experienced before the amputation . At each postoperative interview patients were asked to recall preamputation pain intensity . Location of pain and analgesic requirements were registered . Preamputation pain significantly increased the incidence of stump pain ( P=0.04 ) and phantom pain ( P=0.04 ) after 1 week and the incidence of phantom pain after 3 months ( P=0.03 ) . About 42 % of the patients reported that their phantom pain resembled the pain they had experienced at the time of the amputation . However , there was no relation between the patients ' own opinion about similarity between preamputation pain and phantom pain and the actual similarity found when comparing pre‐ and postoperative recordings of pain . Patients significantly overestimated preamputation pain intensity after 6 months",
"Thirty subjects undergoing posterolateral thoracotomy were allocated r and omly to receive one of two analgesic regimens : group Pre received i.v . morphine , i.m . diclofenac and intercostal nerve blocks from T2 to T11 , 20 min before operation and placebo injections after operation . Group Post received placebo injections before operation , and i.v . morphine , i.m . diclofenac and intercostal nerve blocks from T2 to T11 at the end of surgery , before discontinuation of anaesthesia . Visual analogue pain scores , extent and duration of intercostal nerve block , analgesic consumption and complications were assessed during the postoperative period by a single blinded observer . Subjects were followed-up for a minimum of 12 months to determine the incidence of post-thoracotomy pain syndrome . During the first 48 h after operation there were lower pain scores in group Pre when taking a vital capacity breath but there were no significant differences between the groups in any other measure . The effects of pre-emptive analgesia given before surgery appeared to be relatively modest in terms of analgesia , analgesic consumption and long-term outcome and were of limited clinical significance",
"BACKGROUND The pain of thoracotomy may be related to trauma to the intercostal nerves . METHODS This was a prospect i ve r and omized study of 160 patients . All patients had a functioning epidural , similar type and size thoracotomy , an intercostal muscle flap ( ICM ) harvested before rib spreading , inferior rib drilling , and postoperative pain management . In one group , the ICM was left intact distally and it dangled ( D group ) ; the ICM in the other was cut distally ( C group ) . Pain was assessed using multiple pain scores . Outcomes assessed were qualitative and quantitative pain scores , number of ribs broken , spirometric values , analgesic use , and return to baseline activity for postoperative days 1 to 5 and weeks 2 , 3 , 4 , 8 , and 12 . RESULTS The D group had 85 patients and the C group , 75 . The groups had similar demographics , types of procedures , and histology . Intrahospital pain scores were similar ; however , at postoperative weeks 3 , 4 , 8 , and 12 , the D group had significantly lower mean numeric pain scores and was using fewer analgesics ( p to baseline activity ( p = 0.002 ) . CONCLUSIONS An ICM flap reduces pain . Harvesting and then leaving the ICM flap intact instead of cutting it before rib spreading further reduced thoracotomy pain . This technique , when added to rib drilling , leads to reduced pain on postoperative weeks 3 to 12 , to quicker return to baseline activity , and lessens the need for analgesics",
"Forty-five patients who underwent anterolateral and posterolateral thoracotomy were studied to compare the relative efficacy of cryoanalgesia , epidural morphine , intrapleural analgesia , and intravenous morphine for relief of postoperative pain and prevention of deterioration in pulmonary function . Spirometry ( FEV1 , FVC ) was performed preoperatively and postoperatively . Patients ' pain was assessed using the 0 to 100 mm visual analog scale . Because intravenous morphine was used to supplement pain relief in the patients who received intrapleural analgesia and cryoanalgesia , total morphine use was compared to that administered to patients in the intravenous morphine group . Epidural morphine was found to offer better pain relief than the other treatment modalities . There were no differences in spirometric testing between the groups at any time during the study . Although the number of evaluable patients was insufficient to draw definitive conclusions , 12-week follow-up suggested a difference in the incidence of post-thoracotomy pain syndrome in patients who received cryoanalgesia . It is concluded that post-thoracotomy pain is best relieved with epidural morphine , compared to intrapleural analgesia , cryoanalgesia , and parenteral morphine . There was no change in the deterioration in spirometric tests after thoracotomy , nor was there any advantage offered by cryoanalgesia or intrapleural analgesia over intravenous morphine , with respect to pain relief",
"This study was performed to evaluate the effects of cryoanalgesia combined with thoracic epidural analgesia on pain and respiratory complications in patients undergoing thoracotomy . Ninety patients were prospect ively r and omised to epidural analgesia alone ( n = 45 ) or epidural analgesia and cryoanalgesia combined ( n = 45 ) . We monitored the use of rescue pain medication and changes in forced vital capacity and forced expired volume in 1 s , and recorded pain and opioid‐related side‐effects during the immediate postoperative period . The incidence of post‐thoracotomy pain and numbness were also assessed up to the sixth month after surgery . Cryoanalgesia combined with thoracic epidural analgesia was associated with earlier recovery in pulmonary function , less pain during movement and a lower daily requirement for rescue analgesia one week after surgery . However , the combination of cryoanalgesia and epidural analgesia failed to decrease the incidence of long‐term pain and numbness . In view of its associated long‐term morbidity , cryoanalgesia combined with thoracic epidural analgesia is not recommended for patients undergoing thoracotomy",
"OBJECTIVE Two different surgical accesses combined with st and ard pain management procedures are compared regarding early and intermediate pulmonary function and pain relief . METHODS In a prospect i ve study , 15 consecutive patients undergoing video-thoracoscopy for pulmonary wedge resection ( group 1 ) were matched to 15 patients undergoing st and ard postero-lateral thoracotomy for lobectomy ( group 2 ) according to age , gender and preoperative pulmonary function . Postoperative pain control consisted of patient controlled analgesia in group 1 and epidural analgesia in group 2 . Pain intensity was scored from 0 - 4 . The predicted postoperative pulmonary function ( FVC and FEV 1 ) after lobectomies was calculated from the preoperative value according to the extent of resection . A clinical measurement was obtained after a mean follow-up time of 4.2 months . RESULTS The ratios of postoperative measured to predicted values of FVC and FEV1 for group 1 compared with group 2 were 0.64 + /- 0.15 and 0.65 + /- 0.14 compared with 0.60 + /- 0.19 and 0.59 + /- 0.13 , resp . ( both n.s . ) at the first day postoperative ; 0.92 + /- 0.18 and 0.95 /- 0.17 compared with 0.76 + /- 0.20 ( P Pain intensity score one day after surgery ranged from 0.4 ( resting position ) to 1.6 ( coughing ) for group 1 , and from 0.3 to 1.2 for group 2 . Thirty-six percent of the thoracoscopy patients and 33 % of the thoracotomy group complained of persistent pain or discomfort on the site of the operation after 3 - 18 months . CONCLUSION Post-thoracotomy pain can be effectively controlled with epidural analgesia and pain intensity is no higher than in patients after thoracoscopy who are managed with patient controlled analgesia . FVC is slightly more decreased after thoracotomy during the early postoperative period . FVC and FEV 1 approach the predicted values after four months in both groups . The rate of persistent pain is similar after thoracoscopy and thoracotomy",
"Background : Pain becomes chronic in 22–67 % of patients who undergo a thoracotomy . Thoracic epidural analgesia ( TEA ) has replaced less invasive methods to manage postoperative pain . We wanted to find out if active use of TEA , combined with extended pain management at home , reduces the incidence of chronic post‐thoracotomy pain ",
"Video-assisted thoracic surgery has been adopted by some thoracic surgeons as the preferred approach over thoracotomy for many benign and malignant diseases of the chest . However , little concrete evidence exists to support this technique as the superior approach . This r and omized study was carried out to define the advantages of video-assisted lobectomy over muscle-sparing thoracotomy and lobectomy . Sixty-one patients with presumed clinical stage I non-small-cell lung cancer were entered into the study . Each patient was r and omized to muscle-sparing thoracotomy and lobectomy or video-assisted lobectomy . Six patients were excluded from the study either because final pathologic results revealed nonmalignant disease ( 3 patients ) or because an attempted video-assisted lobectomy was converted to a thoracotomy . This left 30 patients in the thoracotomy group and 25 patients in the video-assisted group . No significant differences existed between the two groups in operating time , intraoperative blood loss , duration of chest tube drainage , or length of hospital stay . Significantly more postoperative complications occurred in the thoracotomy group ( p prolonged air leaks . Return to work time was not an issue because the majority of the patients were either retired or not working at the time of the operation . Only three patients had persistent postthoracotomy pain ( thoracotomy , n = 2 ; video-assisted lobectomy , n = 1 ) . We conclude that video-assisted lobectomy was not associated with a significant decrease in duration of chest tube drainage , length of hospital stay , postthoracotomy pain , or , in this group of patients , a faster recovery time and return to work . Video-assisted lobectomy continues to expose the patient to the risk of a major pulmonary resection being done in an essentially closed chest . These results illustrate the need for critical evaluation of video-assisted thoracic surgery before the procedure is accepted as a superior approach based on presumed and thus far unproved advantages",
"OBJECTIVE Our question naire study set out to assess the prevalence of chronic pain after thoracic surgery , the contribution of the neuropathic component of chronic pain and the impact of chronic pain on patients ' lives . METHODS A question naire was sent to 1152 patients who had undergone thoracic surgery in our department between 7 months and 7 years ago . The question naire was design ed specifically for the study and included questions on neuropathic symptoms . Responses were correlated with data from our prospect ively entered data base for analysis . RESULTS Nine hundred and forty-eight people were included in the study , of which 600 responded ( 63 % ) . Prevalence of chronic pain is 57 % at 7 - 12 months , 36 % at 4 - 5 years and 21 % at 6 - 7 years . Patient age , consultant and time since the operation all have significant effects . Surgical approach ( video-assisted thoracoscopic surgery , thoracotomy ) and diagnosis are not significant . Thirty-nine percent of those with pain take analgesia , 46 % felt their pain is their worst medical problem and 40 % reported it limits their daily activities . The prevalence of each neuropathic symptom is between 35 and 83 % . The presence of a neuropathic symptom is associated with significantly more severe pain , more analgesia use and pain more likely to limit daily activity . CONCLUSIONS Chronic pain has a significant prevalence and impact on patients ' lives for several years after thoracic surgery . Nerve dysfunction is associated with more severe pain , a greater impact and tends to persist . The reason for the individual consultant being an important factor in post-thoracotomy pain needs further investigation",
"Objectives Prolonged activation of pain centers is a proposed cause of chronic pain syndromes . Women are at particular risk for chronic pain as they tend to more readily detect pain and to attenuate it less than men . We set out to determine whether sex affected pain and recovery after major surgery by analyzing data originally collected to determine the effect of the timing of epidural analgesia on long-term outcome after thoracotomy . Methods Patients presenting for lobectomy , segmentectomy , or bilobectomy , but not pneumonectomy or chest wall resection , were enrolled . Pain , physical activity , and the extent that pain interfered with activities after surgery were prospect ively assessed with st and ard question naires ( Brief Pain Inventory and physical component score of SF-36 ) on postoperative days 1 to 5 , and at postoperative weeks 4 , 8 , 12 , 24 , 36 , and 48 by a blinded research assistant . Perioperative care was st and ardized and included patient-controlled thoracic epidural analgesia until thoracostomy tube removal . Results Fifty eight men and 62 women were enrolled . Women reported more pain than men throughout the entire study period , and they had a higher rate of nonsteroidal anti-inflammatory drug use , but not opioid use . This increased pain was not explained by incision type , surgeon , tumor type , or tumor stage . Older patients reported less pain after discharge than younger patients . Postoperative physical activity levels were significantly less than those reported preoperatively , but did not differ by sex . Discussion Women have a distinctly different pain experience than men after thoracic surgery and probably require novel and /or multimodal analgesic regimens to improve their comfort",
"Objective To compare laparoscopic with open hernia repair in a r and omized clinical trial at a median follow-up of 5 years . Summary Background Data Follow-up of patients in clinical trials evaluating laparoscopic hernia repair has been short . Methods Of 379 consecutive patients admitted for surgery under the care of one surgeon , 300 were r and omized to totally extraperitoneal hernia repair or open repair , with the open operation individualized to the patient ’s age and hernia type . All patients , both r and omized and nonr and omized , were followed up by clinical examination annually by an independent observer . Results Recurrence rates were similar for both r and omized groups . In 1 of the 79 nonr and omized patients , a recurrent hernia developed . Groin or testicular pain was the most common symptom on follow-up of r and omized patients . The most common reason for reoperation was development of a contralateral hernia , which was noted in 9 % of patients ; 11 % of all patients died on follow-up , mainly as a result of cardiovascular disease or cancer . Conclusions These data show a similar outcome for laparoscopic and open hernia repair , and both procedures have a place in managing this common problem",
"BACKGROUND Thoracic surgeons spend a lot of time treating the pain of thoracotomy . METHODS A total of 119 consecutive patients underwent elective thoracotomy . They were prospect ively r and omized into two groups . One group received an injection of 1 % lidocaine with epinephrine in the planned skin incision just before thoracotomy , and the other group received an equal amount of saline and epinephrine . All patients had a functioning preoperative epidural ; a skin incision the width of their latissimus dorsi muscle , which was cut ; sparing of the serratus anterior muscle ; undercutting of the sixth rib ; intercostal nerve blocks before rib spreading ; a similar number of chest tubes and pulmonary resections ; and comparable postoperative pain management . Pain was objectified by a numeric pain score , a visual pain score , and by the Modified McGill pain question naire each day in the hospital , and at 3 , 6 , and 12 months postoperatively . RESULTS There were 66 patients in the lidocaine group ( L group ) and 53 patients in the saline group ( S group ) . Although a trend was noted toward less pain in the L group during the first 3 postoperative days ( on the numeric pain scale only ) the difference was not statistically significant in overall pain in the hospital or at 3 , 6 , and 12 months after the operation . Other pain scores and descriptors were similar throughout . CONCLUSIONS The injection of lidocaine and epinephrine in the skin just before thoracotomy does not decrease the amount or type of pain during the hospital stay or at 3 , 6 , and 12 months after surgery",
"Objective : To examine incision and breast pain and discomfort , and their predictors in women 12 months following sternotomy . Design : Extension survey following participation in a clinical trial . Setting : 10 Canadian centres . Patients : Women ( n = 326 ) who completed the Women ’s Recovery from Sternotomy Trial . Interventions : None . Main outcome measures : Pain and discomfort data ( numeric rating scales ) collected by st and ardised interview at 5 days , 12 weeks and 12 months following sternotomy . Results : More patients reported having incision or breast discomfort ( 46.6 % ) than pain ( 18.1 % ) at 12 months postoperatively . No symptoms at 5 days postoperatively were significantly associated with symptom presence at 12 postoperative months . However , having incision pain and discomfort as well as breast pain and discomfort at 12 postoperative weeks was associated with incision pain ( odds ratio ( OR ) = 3.26 , 95 % confidence interval ( CI ) 1.51 to 7.07 ) , incision discomfort ( OR = 4.87 , 95 % CI 3.01 to 7.88 ) , breast pain ( OR = 9.36 , 95 % CI 3.91 to 22.38 ) and breast discomfort ( OR = 6.42 , 95 % CI 3.62 to 11.37 ) , respectively , at 12 postoperative months . Increasing chest circumference was associated with having ongoing incision pain ( OR = 1.12 , 95 % CI 1.03 to 1.21 ) and breast pain ( OR = 1.10 , 95 % CI 1.00 to 1.22 ) . Harvesting of bilateral internal mammary arteries ( IMAs ) was associated with having ongoing incision pain ( OR = 4.71 , 95 % CI 1.54 to 14.3 ) , while harvesting only the left IMA was associated with having ongoing breast pain ( OR = 2.78 , 95 % CI 1.06 to 7.32 ) and breast discomfort ( OR 1.80 , 95 % CI 1.02 to 3.19 ) . Conclusions : Patients reported incision and breast pain and discomfort as long as 12 months post-sternotomy . Improved management of postoperative pain and discomfort up to at least 12 weeks following surgery may render reduced long-term pain and discomfort symptoms"
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Since after 2006 when the first edition of practice guidelines for gynecologic oncologic cancer treatment was released , the Korean Society of Gynecologic Oncology ( KSGO ) has published the following editions on a regular basis to suggest the best possible st and ard care considering up date d scientific evidence as well as medical environment including insurance coverage . The Guidelines Revision Committee was summoned to revise the second edition of KSGO practice guidelines , which was published in July 2010 , and develop the third edition . The current guidelines cover strategies for diagnosis and treatment of primary and recurrent ovarian cancer . In this edition , we introduced an advanced format based on evidence -based medicine , collecting up-to- date data mainly from MEDLINE , EMBASE , and Cochrane Library CENTRAL , and conducting a meta- analysis with systematic review . Eight key questions were raised by the committee members . For every key question , recommendations were developed by the consensus meetings and provided with evidence level and strength of the recommendation
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[
"PURPOSE A phase II trial was conducted to determine the activity of prolonged oral etoposide in platinum-resistant and platinum-sensitive ovarian carcinoma . PATIENTS AND METHODS Platinum-resistant disease was defined as progression on platinum-based chemotherapy or recurrence within 6 months of completing therapy . The starting dose was 50 mg/m2/d ( 30 mg/m2/d for prior radiotherapy ) for 21 days , every 28 days . A dose escalation to a maximum dose of 60 mg/m2/d was prescribed . RESULTS Of 99 patients entered , 97 were assessable for toxicity and 82 were assessable for response . Among 41 platinum-resistant patients a 26.8 % response rate ( 7.3 % complete response [ CR ] and 19.5 % partial response [ PR ] rate ) occurred . The median response duration was 4.3 months ( range , 1.3 to 8.7 ) , median progression-free interval ( PFI ) was 5.7 months ( range , 0.8 to 30.8 + ) , and median survival time was 10.8 months ( range , 1.9 to 45.8 ) . Twenty-five of 41 platinum-resistant patients had also previously received paclitaxel ; of which eight ( 32 % ) responded . Among 41 platinum-sensitive patients , a 34.1 % response rate ( 14.6 % CR and 19.5 % PR rate ) occurred . The median response duration was 7.5 months ( range , 1.9 to 15.2 + ) , median PFI was 6.3 + months ( range , 0.9 to 20.4 ) , and median survival time was 16.5 + months ( range , 0.9 to 34.8 ) . Of 97 patients assessable for toxicity , grade 3 or 4 hematologic toxicity was common , with leukopenia occurring in 41.2 % ( grade 3 , 29 % ; grade 4 , 12 % ) , neutropenia in 45.4 % ( grade 3 , 20 % ; grade 4 , 25 % ) , thrombocytopenia in 9 % ( grade 3 , 5 % ; grade 4 , 4 % ) , and anemia in 13.4 % . Three treatment-related deaths occurred : two from neutropenic sepsis and one from thrombocytopenic bleeding after an overdose . One patient developed leukemia . CONCLUSION This regimen is active in platinum-resistant and platinum-sensitive ovarian carcinoma . Additionally , the regimen is active in paclitaxel-resistant ovarian carcinoma",
"BACKGROUND Platinum-based chemotherapy doublets are a st and ard of care for women with ovarian cancer recurring 6 months after completion of initial therapy . In this study , we aim ed to explore the roles of secondary surgical cytoreduction and bevacizumab in this population , and report the results of the bevacizumab component here . METHODS The multicentre , open-label , r and omised phase 3 GOG-0213 trial was done in 67 predominantly academic centres in the USA ( 65 centres ) , Japan ( one centre ) , and South Korea ( one centre ) . Eligible patients were adult women ( aged ≥18 years ) with recurrent measurable or evaluable epithelial ovarian , primary peritoneal , or fallopian tube cancer , and a clinical complete response to primary platinum-based chemotherapy , who had been disease-free for at least 6 months following last infused cycle of platinum . Patients were r and omly assigned ( 1:1 ) to st and ard chemotherapy ( six 3-weekly cycles of paclitaxel [ 175 mg/m2 of body surface area ] and carboplatin [ area under the curve 5 ] ) or the same chemotherapy regimen plus bevacizumab ( 15 mg/kg of bodyweight ) every 3 weeks and continued as maintenance every 3 weeks until disease progression or unacceptable toxicity . Individuals who participated in both the bevacizumab objective and surgical objective ( which is ongoing ) were r and omly assigned ( 1:1:1:1 ) to receive either of these two chemotherapy regimens with or without prior secondary cytoreductive surgery . R and omisation for the bevacizumab objective was stratified by treatment-free interval and participation in the surgical objective . The primary endpoint was overall survival , analysed by intention to treat . This study is registered with Clinical Trials.gov , number NCT00565851 . FINDINGS Between Dec 10 , 2007 , and Aug 26 , 2011 , 674 women were enrolled and r and omly assigned to st and ard chemotherapy ( n=337 ) or chemotherapy plus bevacizumab ( n=377 ) . Median follow-up at the end of the trial on Nov 5 , 2014 , was 49·6 months in each treatment group ( IQR 41·5 - 62·2 for chemotherapy plus bevacizumab ; IQR 40·8 - 59·3 for chemotherapy ) , at which point 415 patients had died ( 214 in the chemotherapy group and 201 in the chemotherapy plus bevacizumab group ) . Based on pretreatment stratification data , median overall survival in the chemotherapy plus bevacizumab group was 42·2 months ( 95 % CI 37·7 - 46·2 ) versus 37·3 months ( 32·6 - 39·7 ) in the chemotherapy group ( hazard ratio [ HR ] 0·829 ; 95 % CI 0·683 - 1·005 ; p=0·056 ) . We identified incorrect treatment-free interval stratification data for 45 ( 7 % ) patients ( equally balanced between treatment groups ) ; a sensitivity analysis of overall survival based on the audited treatment-free interval stratification data gave an adjusted HR of 0·823 ( 95 % CI 0·680 - 0·996 ; p=0·0447 ) . In the safety population ( all patients who initiated treatment ) , 317 ( 96 % ) of 325 patients in the chemotherapy plus bevacizumab group had at least one grade 3 or worse adverse event compared with 282 ( 86 % ) of 332 in the chemotherapy group ; the most frequently reported of these in the chemotherapy plus bevacizumab group compared with the chemotherapy group were hypertension ( 39 [ 12 % ] vs two [ 1 % ] ) , fatigue ( 27 [ 8 % ] vs eight [ 2 % ] ) , and proteinuria ( 27 [ 8 % ] vs none ) . Two ( 1 % ) treatment-related deaths occurred in the chemotherapy group ( infection [ n=1 ] and myelodysplastic syndrome [ n=1 ] ) compared with nine ( 3 % ) in the chemotherapy plus bevacizumab group ( infection [ n=1 ] , febrile neutropenia [ n=1 ] , myelodysplastic syndrome [ n=1 ] , secondary malignancy [ n=1 ] ; deaths not classified with CTCAE terms : disease progression [ n=3 ] , sudden death [ n=1 ] , and not specified [ n=1 ] ) . INTERPRETATION The addition of bevacizumab to st and ard chemotherapy , followed by maintenance therapy until progression , improved the median overall survival in patients with platinum-sensitive recurrent ovarian cancer . Although the intention-to-treat analysis for overall survival was not significant , our sensitivity analysis based on corrected treatment-free interval stratification indicates that this strategy might be an important addition to the therapeutic armamentarium in these patients . FUNDING National Cancer Institute and Genentech",
"PURPOSE This r and omized , multicenter , blinded , placebo-controlled phase III trial tested the efficacy and safety of bevacizumab ( BV ) with gemcitabine and carboplatin ( GC ) compared with GC in platinum-sensitive recurrent ovarian , primary peritoneal , or fallopian tube cancer ( ROC ) . PATIENTS AND METHODS Patients with platinum-sensitive ROC ( recurrence ≥ 6 months after front-line platinum-based therapy ) and measurable disease were r and omly assigned to GC plus either BV or placebo ( PL ) for six to 10 cycles . BV or PL , respectively , was then continued until disease progression . The primary end point was progression-free survival ( PFS ) by RECIST ; secondary end points were objective response rate , duration of response ( DOR ) , overall survival , and safety . RESULTS Overall , 484 patients were r and omly assigned . PFS for the BV arm was superior to that for the PL arm ( hazard ratio [ HR ] , 0.484 ; 95 % CI , 0.388 to 0.605 ; log-rank P was 12.4 v 8.4 months , respectively . The objective response rate ( 78.5 % v 57.4 % ; P ) and DOR ( 10.4 v 7.4 months ; HR , 0.534 ; 95 % CI , 0.408 to 0.698 ) were significantly improved with the addition of BV . No new safety concerns were noted . Grade 3 or higher hypertension ( 17.4 % v and proteinuria ( 8.5 % v . The rates of neutropenia and febrile neutropenia were similar in both arms . Two patients in the BV arm experienced GI perforation after study treatment discontinuation . CONCLUSION GC plus BV followed by BV until progression result ed in a statistically significant improvement in PFS compared with GC plus PL in platinum-sensitive ROC",
"BACKGROUND The international st and ard of care for women with suspected advanced ovarian cancer is surgical debulking followed by platinum-based chemotherapy . We aim ed to establish whether use of platinum-based primary chemotherapy followed by delayed surgery was an effective and safe alternative treatment regimen . METHODS In this phase 3 , non-inferiority , r and omised , controlled trial ( CHORUS ) undertaken in 87 hospitals in the UK and New Zeal and , we enrolled women with suspected stage III or IV ovarian cancer . We r and omly assigned women ( 1:1 ) either to undergo primary surgery followed by six cycles of chemotherapy , or to three cycles of primary chemotherapy , then surgery , followed by three more cycles of completion chemotherapy . Each 3-week cycle consisted of carboplatin AUC5 or AUC6 plus paclitaxel 175 mg/m(2 ) , or an alternative carboplatin combination regimen , or carboplatin monotherapy . We did the r and om assignment by use of a minimisation method with a r and om element , and stratified participants according to the r and omising centre , largest radiological tumour size , clinical stage , and prespecified chemotherapy regimen . Patients and investigators were not masked to group assignment . The primary outcome measure was overall survival . Primary analyses were done in the intention-to-treat population . To establish non-inferiority , the upper bound of a one-sided 90 % CI for the hazard ratio ( HR ) had to be less than 1.18 . This trial is registered , number IS RCT N74802813 , and is closed to new participants . FINDINGS Between March 1 , 2004 , and Aug 30 , 2010 , we r and omly assigned 552 women to treatment . Of the 550 women who were eligible , 276 were assigned to primary surgery and 274 to primary chemotherapy . All were included in the intention-to-treat analysis ; 251 assigned to primary surgery and 253 to primary chemotherapy were included in the per- protocol analysis . As of May 31 , 2014 , 451 deaths had occurred : 231 in the primary -surgery group versus 220 in the primary -chemotherapy group . Median overall survival was 22.6 months in the primary -surgery group versus 24.1 months in primary chemotherapy . The HR for death was 0.87 in favour of primary chemotherapy , with the upper bound of the one-sided 90 % CI 0.98 ( 95 % CI 0.72 - 1.05 ) . Grade 3 or 4 postoperative adverse events and deaths within 28 days after surgery were more common in the primary -surgery group than in the primary -chemotherapy group ( 60 [ 24 % ] of 252 women vs 30 [ 14 % ] of 209 , p=0.0007 , and 14 women [ 6 % ] vs 1 woman [ grade 3 or 4 postoperative adverse event was haemorrhage in both groups ( 8 women [ 3 % ] in the primary -surgery group vs 14 [ 6 % ] in the primary -chemotherapy group ) . 110 ( 49 % ) of 225 women receiving primary surgery and 102 ( 40 % ) of 253 receiving primary chemotherapy had a grade 3 or 4 chemotherapy related toxic effect ( p=0.0654 ) , mostly uncomplicated neutropenia ( 20 % and 16 % , respectively ) . One fatal toxic effect , neutropenic sepsis , occurred in the primary -chemotherapy group . INTERPRETATION In women with stage III or IV ovarian cancer , survival with primary chemotherapy is non-inferior to primary surgery . In this study population , giving primary chemotherapy before surgery is an acceptable st and ard of care for women with advanced ovarian cancer . FUNDING Cancer Research UK and the Royal College of Obstetricians and Gynaecologists",
"BACKGROUND This multicentre phase II open-label study evaluated safety and antitumour activity of oxaliplatin in cisplatin or carboplatin ( cis/carboplatin ) + /- taxane-pretreated advanced ovarian cancer ( AOC ) patients . PATIENTS AND METHODS Forty-eight patients received oxaliplatin 130 mg/M2 intravenously every 3 weeks , 94 % having a performance status ( PS ) 0 - 1 . All were pretreated with cis/carboplatin and 21 ( 44 % ) with paclitaxel . The median number of involved organs was two , 18 ( 38 % ) had liver metastasis , 23 ( 48 % ) were platinum-resistant and 14 ( 29 % ) were taxane-resistant . Forty-two patients were evaluable for a response , 18 ( 43 % ) were platinum-resistant and 11 ( 26 % ) were taxane-resistant . RESULTS A total of 253 cycles was administered ( median : 5.5/patient ) . Median cumulative oxaliplatin dose was 666 mg/m2 . National Cancer Institute-Common Toxicity Criteria toxicity analysis showed that seven patients ( 15 % ) had grade 3/4 thrombocytopenia , two patients ( 4 % ) had grade 3 neutropenia , and one patient had grade 3 anaemia . Eleven patients ( 23 % ) experienced grade 3 neurosensory toxicity . Of the 29 patients with peripheral neuropathy at the end of treatment , 55 % had recovered or improved 1 month later . Eleven objective responses ( two complete ) were obtained in the 42 evaluable patients [ ORR 26 % , 95 % confidence interval ( CI ) 14 % to 42 % ] , with 10/24 ( 42 % , 95 % CI 22 % to 63 % ) in platinum-sensitive , and 1 of 18 ( 5.6 % , 95 % CI 0 % to 27 % ) in platinum-resistant patients . Median response duration was 9.2 months ( 95 % CI 6.6 % to 11.8 % ) , and median progression-free and overall survival in all treated patients were 4.3 months ( 95 % CI 3.0 % to 5.7 % ) and 15.0 months ( 95 % CI 11.1 % to 18.8 % ) , respectively . CONCLUSION Oxaliplatin has a good safety profile and is active in cis/carboplatin + /- paclitaxel-pretreated AOC patients",
"PURPOSE We aim ed at investigating the efficacy , tolerability , and quality of life ( QOL ) of gemcitabine ( GEM ) compared with pegylated liposomal doxorubicin ( PLD ) in the salvage treatment of recurrent ovarian cancer . PATIENTS AND METHODS A phase III r and omized multicenter trial was planned to compare GEM ( 1,000 mg/m(2 ) on days 1 , 8 , and 15 every 28 days ) with PLD ( 40 mg/m(2 ) every 28 days ) in ovarian cancer patients who experienced treatment failure with only one platinum/paclitaxel regimen and who experienced recurrence or progression within 12 months after completion of primary treatment . RESULTS One hundred fifty-three patients were r and omly assigned to PLD ( n = 76 ) or GEM ( n = 77 ) . Treatment arms were well balanced for clinicopathologic characteristics . Grade 3 or 4 neutropenia was more frequent in GEM-treated patients versus PLD-treated patients ( P = .007 ) . Grade 3 or 4 palmar-plantar erythrodysesthesia was documented in a higher proportion of PLD patients ( 6 % ) versus GEM patients ( 0 % ; P = .061 ) . The overall response rate was 16 % in the PLD arm compared with 29 % in the GEM arm ( P = .056 ) . No statistically significant difference in time to progression ( TTP ) curves according to treatment allocation was documented ( P = .411 ) . However , a trend for more favorable overall survival was documented in the PLD arm compared with the GEM arm , although the P value was of borderline statistical significance ( P = .048 ) . Statistically significantly higher global QOL scores were found in PLD-treated patients at the first and second postbaseline QOL assessment s. CONCLUSION GEM does not provide an advantage compared with PLD in terms of TTP in ovarian cancer patients who experience recurrence within 12 months after primary treatment but should be considered in the spectrum of drugs to be possibly used in the salvage setting",
"PURPOSE The aim of this study was to perform an evaluation of outcome and the role of surgical staging components in malignant germ cell tumors ( GCT ) of the ovary in children and adolescents . METHODS From 1990 to 1996 , 2 intergroup trials for malignant GCT were undertaken by Pediatric Oncology Group ( POG ) and Children 's Cancer Study Group ( CCG ) . Stage I-II patients were treated with surgical resection and 4 cycles of st and ard dose cisplatin ( 100 mg/m2/cycle ) , etoposide , and bleomycin ( PEB ) chemotherapy . Stage III-IV patients were treated with surgical resection and r and omly assigned to chemotherapy with PEB or high-dose cisplatin ( 200 mg/m2/cycle ) with etoposide and bleomycin ( HDPEB ) . Patients unresectable at diagnosis had second-look operation after 4 cycles of chemotherapy if residual tumor was seen on imaging studies . IRB approval of the protocol s was obtained at each participating institution . An analysis of outcome data , operative notes , and pathology reports in girls with ovarian primary site was done for this report . RESULTS There were 131 patients with ovarian primary tumors of 515 entered on these studies . Mean age was 11.9 years ( range , 1.4 to 20 years ) . Six-year survival rate was stage , I 95.1 % ; stage II , 93.8 % ; stage III , 98.3 % ; stage IV , 93.3 % . In only 3 of 131 patients were surgical guidelines followed completely . Surgical omissions result ing in protocol noncompliance result ed from failure to biopsy bilateral nodes ( 97 % ) , no omentectomy ( 36 % ) , no peritoneal cytology ( 21 % ) , no contralateral ovary biopsy ( 59 % ) . More aggressive procedure than recommended by guidelines included total hysterectomy and bilateral salpingo-oophorectomy in 6 patients and retroperitoneal node dissection in 10 patients . Correlation of gross operative findings with pathology results was carried out for ascites , lymph nodes , implants , omentum , and contralateral ovary . CONCLUSIONS Pediatric ovarian malignant GCT ( stages I-IV ) have excellent survival with conservative surgical resection and platinum-based chemotherapy . Survival appears to have been unaffected by deviations from surgical guidelines . New surgical guidelines are proposed based on correlation of gross findings , histology , and outcome in these intergroup trials",
"PURPOSE To estimate the antitumor activity of pemetrexed in patients with persistent or recurrent platinum-resistant epithelial ovarian or primary peritoneal cancer and to determine the nature and degree of toxicities . PATIENTS AND METHODS A phase II trial was conducted by the Gynecologic Oncology Group . Patients must have had cancer that had progressed on platinum-based primary chemotherapy or recurred within 6 months . Pemetrexed at a dose of 900 mg/m(2 ) was to be administered as an intravenous infusion over 10 minutes every 21 days . Dose delay and adjustment was permitted for toxicity . Treatment was continued until disease progression or unacceptable adverse effects . RESULTS From July 6 , 2004 , to August 23 , 2006 , 51 patients were entered . A total of 259 cycles ( median , four ; range one to 19 cycles ) of pemetrexed were administered , with 40 % of patients receiving six or more cycles . Overall , the treatment was well tolerated . More serious toxicities ( grade 3 and 4 ) included neutropenia in 42 % , leukopenia in 25 % , anemia in 15 % , and constitutional in 15 % of patients . No treatment-related deaths were reported . One patient ( 2 % ) had a complete and nine patients ( 19 % ) had partial responses , with a median duration response of 8.4 months . Seventeen patients ( 35 % ) had stable disease for a median of 4.1 months . Eighteen patients ( 38 % ) had increasing disease . Three patients ( 6 % ) were not assessable . Median progression-free survival was 2.9 months , and overall survival was 11.4 months . CONCLUSION Pemetrexed has sufficient activity in the treatment of recurrent platinum-resistant ovarian cancer at the dose and schedule tested to warrant further investigation",
"PURPOSE There is a critical need to find new antineoplastic drugs that are active in platinum-refractory ovarian cancer . We conducted a phase II trial of single-agent ifosfamide with mesna uroprotection in patients with ovarian cancer previously treated with an organoplatinum compound to assess its activity in this clinical setting . PATIENTS AND METHODS Ifosfamide ( 1.0 or 1.2 g/m2/d for 5 days , delivered on a monthly schedule ) was administered to the 57 patients entered onto this trial . Dose reductions were permitted for unacceptable toxicities . RESULTS Toxicity included severe bone marrow suppression ( WBC count less than 1,000/microL and /or platelet count less than 50,000/microL ) , renal dysfunction ( serum creatinine level greater than 2.0 mg/dL ) , and reversible CNS dysfunction ( disorientation , hallucinations , somnolence , and agitation ) , which occurred in 20 % , 14 % , and 12 % of patients , respectively . Of 41 patients with strictly defined platinum-refractory ovarian cancer , five ( 12 % ) demonstrated a partial ( four ) or complete ( one ) response to this treatment program . CONCLUSION Single-agent ifosfamide has modest but unequivocal activity in platinum-resistant ovarian cancer . Further studies of this drug used as a front-line agent along with an organoplatinum compound or as part of a dose-intensification program with bone marrow , peripheral stem cell , or colony-stimulating factor support are indicated . In addition , single-agent ifosfamide is a reasonable st and ard second-line treatment strategy in appropriately selected patients with platinum-refractory ovarian cancer",
"PURPOSE Ovarian cancer ( OC ) patients experiencing progressive disease ( PD ) within 6 months of platinum-based therapy in the primary setting are considered platinum resistant ( Pt-R ) . Currently , pegylated liposomal doxorubicin ( PLD ) is a st and ard of care for treatment of recurrent Pt-R disease . On the basis of promising phase II results , gemcitabine was compared with PLD for efficacy and safety in taxane-pretreated Pt-R OC patients . PATIENTS AND METHODS Patients ( n = 195 ) with Pt-R OC were r and omly assigned to either gemcitabine 1,000 mg/m2 ( days 1 and 8 ; every 21 days ) or PLD 50 mg/m2 ( day 1 ; every 28 days ) until PD or undue toxicity . Optional cross-over therapy was allowed at PD or at withdrawal because of toxicity . Primary end point was progression-free survival ( PFS ) . Additional end points included tumor response , time to treatment failure , survival , and quality of life . RESULTS In the gemcitabine and PLD groups , median PFS was 3.6 v 3.1 months ; median overall survival was 12.7 v 13.5 months ; overall response rate ( ORR ) was 6.1 % v 8.3 % ; and in the subset of patients with measurable disease , ORR was 9.2 % v 11.7 % , respectively . None of the efficacy end points showed a statistically significant difference between treatment groups . The PLD group experienced significantly more h and -foot syndrome and mucositis ; the gemcitabine group experienced significantly more constipation , nausea/vomiting , fatigue , and neutropenia but not febrile neutropenia . CONCLUSION Although this was not design ed as an equivalency study , gemcitabine and PLD seem to have a comparable therapeutic index in this population of Pt-R taxane-pretreated OC patients . Single-agent gemcitabine may be an acceptable alternative to PLD for patients with Pt-R OC",
"OBJECTIVES Pegylated liposomal doxorubicin is one of the preferred alternatives for ovarian cancer patients with early relapse ( taxane/carboplatin for late relapse ( > 12 months ) , but the optimal therapy for the partially platinum-sensitive ( 6 - 12 months ) population has not been defined . This single-arm phase II trial was design ed to assess the efficacy of pegylated liposomal doxorubicin (PLD)/carboplatin in ovarian cancer patients who relapse between 6 and 12 months after initial treatment with platinum-based chemotherapy . METHODS Ovarian cancer patients who previously completed a course of therapy with paclitaxel/carboplatin were administered PLD 30 mg/m(2 ) followed by carboplatin AUC 5 mg/mL/minute every 4 weeks . RESULTS Fifty-eight patients were enrolled in the study and 54 were eligible for the efficacy analysis , of whom most ( 75 % ) received at least 6 cycles of PLD/carboplatin . The objective response rate was 46 % ( 4 % CR and 42 % PR ) , with an additional 33 % experiencing disease stabilization > 6 months . For those patients with measurable CA-125 , the response rate was 66 % ( 28 % CR and 38 % PR ) , with an additional 18 % experiencing disease stabilization > 6 months . Median time-to-progression was 10 months ( 1.5 - 25 ) . Median overall survival was 19.1 months ( 2.2 - 38.9 ) . The most frequent adverse effects were neutropenia , thrombocytopenia , and constipation . CONCLUSIONS The combination of PLD/carboplatin is efficacious and well tolerated in women with partially platinum-sensitive ovarian cancer and represents a valuable alternative for patients who relapse within 6 - 12 months of completing paclitaxel/carboplatin chemotherapy",
"BACKGROUND Olaparib , a poly(ADP-ribose ) polymerase ( PARP ) inhibitor , has previously shown efficacy in a phase 2 study when given in capsule formulation to all-comer patients with platinum-sensitive , relapsed high- grade serous ovarian cancer . We aim ed to confirm these findings in patients with a BRCA1 or BRCA2 ( BRCA1/2 ) mutation using a tablet formulation of olaparib . METHODS This international , multicentre , double-blind , r and omised , placebo-controlled , phase 3 trial evaluated olaparib tablet maintenance treatment in platinum-sensitive , relapsed ovarian cancer patients with a BRCA1/2 mutation who had received at least two lines of previous chemotherapy . Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status at baseline of 0 - 1 and histologically confirmed , relapsed , high- grade serous ovarian cancer or high- grade endometrioid cancer , including primary peritoneal or fallopian tube cancer . Patients were r and omly assigned 2:1 to olaparib ( 300 mg in two 150 mg tablets , twice daily ) or matching placebo tablets using an interactive voice and web response system . R and omisation was stratified by response to previous platinum chemotherapy ( complete vs partial ) and length of platinum-free interval ( 6 - 12 months vs ≥12 months ) and treatment assignment was masked for patients , those giving the interventions , data collectors , and data analysers . The primary endpoint was investigator-assessed progression-free survival and we report the primary analysis from this ongoing study . The efficacy analyses were done on the intention-to-treat population ; safety analyses included patients who received at least one dose of study treatment . This trial is registered with Clinical Trials.gov , number NCT01874353 , and is ongoing and no longer recruiting patients . FINDINGS Between Sept 3 , 2013 , and Nov 21 , 2014 , we enrolled 295 eligible patients who were r and omly assigned to receive olaparib ( n=196 ) or placebo ( n=99 ) . One patient in the olaparib group was r and omised in error and did not receive study treatment . Investigator-assessed median progression-free survival was significantly longer with olaparib ( 19·1 months [ 95 % CI 16·3 - 25·7 ] ) than with placebo ( 5·5 months [ 5·2 - 5·8 ] ; hazard ratio [ HR ] 0·30 [ 95 % CI 0·22 - 0·41 ] , p anaemia ( 38 [ 19 % ] of 195 patients in the olaparib group vs two [ 2 % ] of 99 patients in the placebo group ) , fatigue or asthenia ( eight [ 4 % ] vs two [ 2 % ] ) , and neutropenia ( ten [ 5 % ] vs four [ 4 % ] ) . Serious adverse events were experienced by 35 ( 18 % ) patients in the olaparib group and eight ( 8 % ) patients in the placebo group . The most common in the olaparib group were anaemia ( seven [ 4 % ] patients ) , abdominal pain ( three [ 2 % ] patients ) , and intestinal obstruction ( three [ 2 % ] patients ) . The most common in the placebo group were constipation ( two [ 2 % ] patients ) and intestinal obstruction ( two [ 2 % ] patients ) . One ( 1 % ) patient in the olaparib group had a treatment-related adverse event ( acute myeloid leukaemia ) with an outcome of death . INTERPRETATION Olaparib tablet maintenance treatment provided a significant progression-free survival improvement with no detrimental effect on quality of life in patients with platinum-sensitive , relapsed ovarian cancer and a BRCA1/2 mutation . Apart from anaemia , toxicities with olaparib were low grade and manageable . FUNDING AstraZeneca",
"PURPOSE A Gynecologic Oncology Group ( GOG ) r and omized phase III trial ( GOG 172 ) in optimal stage III epithelial ovarian cancer showed that intravenous ( IV ) paclitaxel plus intraperitoneal ( IP ) cisplatin and paclitaxel significantly lengthened progression-free survival and overall survival compared with IV paclitaxel and cisplatin . The purpose of this report is to comprehensively evaluate the patient-reported outcomes associated with IP versus IV therapy . PATIENTS AND METHODS Four hundred fifteen eligible women were enrolled onto GOG 172 at member institutions . The Functional Assessment of Cancer Therapy-Trial Outcome Index ( FACT-TOI ; which includes physical , functional , and ovarian subscales ) and neurotoxicity ( Ntx ) and abdominal discomfort ( AD ) subscales were used to assess patient-reported outcomes . Assessment s were completed before r and om assignment , before cycle 4 , and 3 to 6 weeks and 12 months after treatment . RESULTS Physical and functional well-being and ovarian cancer symptoms were significantly worse in the IP arm before cycle 4 ( P AD before cycle 4 ( P Ntx 3 to 6 weeks ( P = .001 ) and 12 months ( P = .003 ) after completing IP treatment . In general , however , the quality of life of both groups improved over time . CONCLUSION During active treatment , patients on the IP arm experienced more health-related quality -of-life disruption , AD , and Ntx compared with patients receiving conventional IV therapy . However , only Ntx remained significantly greater for IP patients 12 months after treatment . This trade-off should be included when discussing treatment options with patients . Future studies to mitigate the added burden associated with IP therapy are planned",
"OBJECTIVE Docetaxel and carboplatin are active in relapsed ovarian , peritoneal and tubal cancer . Recently , two prospect ive-r and omized trials showed an advantage of carboplatin combination regimen with paclitaxel or gemcitabine over carboplatinum alone in platinum-sensitive cases . The question on the most effective combination with the best tolerable side effects still needs to be answered . METHODS Eligible patients had recurrent ovarian , peritoneal or tubal cancer ( platinum-free interval > 6 months ) , performance status 0 - 2 and normal bone marrow , renal and hepatic function . 25 patients ( age 18 - 75 years ) were enrolled into this phase II trial . Patients with debulking operation of recurrence were excluded from this study . Docetaxel 75 mg/m(2 ) via 30-min infusion was given on day 1 followed by carboplatin ( area under curve [ AUC ] 5 ) on day 1 . The administration was repeated every 3 weeks over 6 courses . Primary endpoint of this trial was the response rate ; secondary endpoints were progression-free survival , overall survival and toxicity . RESULTS In the intent-to-treat population , there were 16 ( 64.0 % ) complete and 2 ( 8.0 % ) partial responses result ing in an overall response rate of 72.0 % . Three patients ( 12.0 % ) showed a stable disease and other 2 patients ( 8.0 % ) a progression of cancer . Two patients ( 8.0 % ) were not evaluable for response . Neutropenia was the most frequent G3/G4 hematologic toxicity in 15/25 patients ( 60.0 % ) ; but no neutropenic fever occurred in this trial . Diarrhea G3 was the most frequent G3/G4 non-hematologic toxicity in only 3/25 patients ( 12.0 % ) . Dose-limiting toxicities were hypersensitivity reaction in one and depressive mood alteration requiring therapy in another case . CONCLUSION Carboplatin in combination with docetaxel is highly active and well tolerated in patients with recurrent platinum-sensitive ovarian , peritoneal and tubal cancer . Prospect ive-r and omized trials comparing this with other carboplatin therapeutic doublets in patients with recurrent ovarian cancer are a possible option for the future to answer the question on the best combination regimen",
"BACKGROUND To evaluate the toxicity and efficacy of a newly developed topoisomerase I inhibitor , CKD-602 in second-line therapy of ovarian cancer . METHODS We enrolled 24 patients with recurrent ovarian cancer , of median age 54 years ( range , 39 - 64 ) . Eleven patients had measurable lesions on CT scan , and the other 13 had increased serum CA-125 levels . Eighteen patients had platinum-sensitive disease ( minimum treatment free interval > or = 6 months ) and 6 had platinum-resistant disease ( minimum treatment free interval CKD-602 ( 0.5 mg/m(2)/day ) was administered intravenously for 5 days every 3 weeks . The median number of courses per patient was 6 ( range , 1 to 12 ) . Response was evaluated by the evaluation of the size of the mass by CT scan and CA-125 response . RESULTS The overall response rate was 45.0 % ( 9/20 ) , with 4 patients exhibiting partial responses and 5 patients exhibiting 75 % CA-125 responses in 20 evaluable patients . Of the 9 responsive patients , 8 were platinum-sensitive ( 8/15 , 53.3 % ) and 1 was platinum-resistant ( 1/5 , 20.0 % ) . An additional 5 patients showed stable disease , whereas 6 patients exhibited progressive lesions . Of 24 patients , the most common toxicity was hematological , with grade s 3 or 4 neutropenia developing in all 24 patients ( 100 % ) and in 94 cycles ( 71.7 % ) . Grade 3 thrombocytopenia developed in 4 patients ( 16.7 % ) and 6 cycles ( 4.6 % ) . None of the patients experienced grade s 3 and 4 gastrointestinal toxicities , including nausea , vomiting , and anorexia . CONCLUSIONS The newly developed topoisomerase I inhibitor , CKD-602 , showed activity against both platinum-sensitive and -resistant ovarian cancer , with acceptable toxicity",
"BACKGROUND Paclitaxel and carboplatin given every 3 weeks is st and ard treatment for advanced ovarian carcinoma . Attempts to improve patient survival by including other drugs have yielded disappointing results . We compared a conventional regimen of paclitaxel and carboplatin with a dose-dense weekly regimen in women with advanced ovarian cancer . METHODS Patients with stage II to IV epithelial ovarian cancer , fallopian tube cancer , or primary peritoneal cancer were eligible for enrolment in this phase 3 , open-label , r and omised controlled trial at 85 centres in Japan . Patients were r and omly assigned by computer-generated r and omisation sequence to receive six cycles of either paclitaxel ( 180 mg/m(2 ) ; 3-h intravenous infusion ) plus carboplatin ( area under the curve [ AUC ] 6 mg/mL per min ) , given on day 1 of a 21-day cycle ( conventional regimen ; n=320 ) , or dose-dense paclitaxel ( 80 mg/m(2 ) ; 1-h intravenous infusion ) given on days 1 , 8 , and 15 plus carboplatin given on day 1 of a 21-day cycle ( dose-dense regimen ; n=317 ) . The primary endpoint was progression-free survival . Analysis was by intention to treat ( ITT ) . This trial is registered with Clinical Trials.gov , number NCT00226915 . FINDINGS 631 of the 637 enrolled patients were eligible for treatment and were included in the ITT population ( dose-dense regimen , n=312 ; conventional regimen , n=319 ) . Median progression-free survival was longer in the dose-dense treatment group ( 28.0 months , 95 % CI 22.3 - 35.4 ) than in the conventional treatment group ( 17.2 months , 15.7 - 21.1 ; hazard ratio [ HR ] 0.71 ; 95 % CI 0.58 - 0.88 ; p=0.0015 ) . Overall survival at 3 years was higher in the dose-dense regimen group ( 72.1 % ) than in the conventional treatment group ( 65.1 % ; HR 0.75 , 0.57 - 0.98 ; p=0.03 ) . 165 patients assigned to the dose-dense regimen and 117 assigned to the conventional regimen discontinued treatment early . Reasons for participant dropout were balanced between the groups , apart from withdrawal because of toxicity , which was higher in the dose-dense regimen group than in the conventional regimen group ( n=113 vs n=69 ) . The most common adverse event was neutropenia ( dose-dense regimen , 286 [ 92 % ] of 312 ; conventional regimen , 276 [ 88 % ] of 314 ) . The frequency of grade 3 and 4 anaemia was higher in the dose-dense treatment group ( 214 [ 69 % ] ) than in the conventional treatment group ( 137 [ 44 % ] ; p frequencies of other toxic effects were similar between groups . INTERPRETATION Dose-dense weekly paclitaxel plus carboplatin improved survival compared with the conventional regimen and represents a new treatment option in women with advanced epithelial ovarian cancer . FUNDING Bristol-Myers Squibb",
"PURPOSE Vascular endothelial growth factor ( VEGF ) seems to be a promoter of tumor progression for epithelial ovarian cancer ( EOC ) and primary peritoneal cancer ( PPC ) . We conducted a phase II trial to assess the efficacy and tolerability of single-agent bevacizumab , an anti-VEGF monoclonal antibody . PATIENTS AND METHODS Eligible patients had persistent or recurrent EOC/PPC after one to two prior cytotoxic regimens , measurable disease , and Gynecologic Oncology Group performance status of at least 2 . Treatment consisted of bevacizumab 15 mg/kg intravenously every 21 days until disease progression or prohibitive toxicity . Primary end points were progression-free survival ( PFS ) at 6 months and clinical response . RESULTS The study consisted of 62 eligible and assessable patients , median age 57 years , 41 ( 66.1 % ) having received two prior regimens and 36 ( 58.1 % ) [ CORRECTED ] considered platinum resistant . Grade 3 adverse events at least possibly related to bevacizumab were hematologic ( 1 ) , GI ( 3 ) , hypertension ( 6 ) , thromboembolism ( 1 ) , allergy ( 2 ) , hepatic ( 1 ) , pain ( 3 ) , coagulation ( 1 ) , constitutional ( 1 ) , and dyspnea ( 1 ) . Grade 4 adverse events included pulmonary embolus ( 1 ) , vomiting and constipation ( 1 ) , and proteinuria ( 1 ) . Thirteen patients ( 21.0 % ) experienced clinical responses ( two complete , 11 partial ; median response duration , 10 months ) , and 25 ( 40.3 % ) survived progression free for at least 6 months . Median PFS and overall survival were 4.7 and 17 months , respectively . There was no significant association of prior platinum sensitivity , age , number of prior chemotherapeutic regimens , or performance status with the hazard of progression or death . CONCLUSION Bevacizumab seems to be well tolerated and active in the second- and third-line treatment of patients with EOC/PPC and merits phase III investigation",
"OBJECTIVE Provide long-term follow-up data for women treated in a r and omized multicenter study of pegylated liposomal doxorubicin compared with topotecan . METHODS Patients with epithelial ovarian cancer that recurred after or failed to respond to first-line platinum-based chemotherapy were r and omized to receive pegylated liposomal doxorubicin 50 mg/m(2 ) every 28 days ( n = 239 ) or topotecan 1.5 mg/m(2 ) per day for 5 days every 21 days ( n = 235 ) . Patients were stratified prospect ively based on response to initial platinum-based chemotherapy as well as the presence or absence of bulky disease . Most patients had been previously treated with platinum and taxanes ( 74 % in the pegylated liposomal doxorubicin group and 72 % in the topotecan group ) . Survival data are mature : 87 % of patients have died ( n = 413 ) . RESULTS There was an 18 % reduction in the risk of death for patients treated with pegylated liposomal doxorubicin ( median survival 62.7 weeks for pegylated liposomal doxorubicin and 59.7 weeks for topotecan-treated patients ; HR = 1.216 ; 95 % confidence interval ( CI ) 1.000 - 1.478 ; P = 0.050 ) . The hazard ratio for all r and omized subjects ( includes those r and omized , but never treated ; n = 481 ) was 1.23 ( median survival 63.6 weeks for pegylated liposomal doxorubicin and 57.0 weeks for topotecan-treated patients ; 95 % CI 1.01 - 1.50 ; P = 0.038 ) . For patients with platinum-sensitive disease , there was a 30 % reduction in the risk of death for the pegylated liposomal doxorubicin-treated group ( median survival 107.9 weeks for pegylated liposomal doxorubicin and 70.1 weeks for topotecan-treated patients ; HR = 1.432 ; 95 % CI 1.066 - 1.923 ; P = 0.017 ) . In patients with platinum-refractory disease , survival was similar between treatment groups . CONCLUSION Long-term follow-up demonstrates that treatment with pegylated liposomal doxorubicin significantly prolongs survival compared with topotecan in patients with recurrent and refractory epithelial ovarian cancer . The survival benefit is pronounced in patients with platinum-sensitive disease",
"PURPOSE Olaparib is an oral poly ( ADP-ribose ) polymerase inhibitor with activity in germline BRCA1 and BRCA2 ( BRCA1/2 ) -associated breast and ovarian cancers . We evaluated the efficacy and safety of olaparib in a spectrum of BRCA1/2-associated cancers . PATIENTS AND METHODS This multicenter phase II study enrolled individuals with a germline BRCA1/2 mutation and recurrent cancer . Eligibility included ovarian cancer resistant to prior platinum ; breast cancer with ≥ three chemotherapy regimens for metastatic disease ; pancreatic cancer with prior gemcitabine treatment ; or prostate cancer with progression on hormonal and one systemic therapy . Olaparib was administered at 400 mg twice per day . The primary efficacy end point was tumor response rate . RESULTS A total of 298 patients received treatment and were evaluable . The tumor response rate was 26.2 % ( 78 of 298 ; 95 % CI , 21.3 to 31.6 ) overall and 31.1 % ( 60 of 193 ; 95 % CI , 24.6 to 38.1 ) , 12.9 % ( eight of 62 ; 95 % CI , 5.7 to 23.9 ) , 21.7 % ( five of 23 ; 95 % CI , 7.5 to 43.7 ) , and 50.0 % ( four of eight ; 95 % CI , 15.7 to 84.3 ) in ovarian , breast , pancreatic , and prostate cancers , respectively . Stable disease ≥ 8 weeks was observed in 42 % of patients ( 95 % CI , 36.0 to 47.4 ) , including 40 % ( 95 % CI , 33.4 to 47.7 ) , 47 % ( 95 % CI , 34.0 to 59.9 ) , 35 % ( 95 % CI , 16.4 to 57.3 ) , and 25 % ( 95 % CI , 3.2 to 65.1 ) of those with ovarian , breast , pancreatic , or prostate cancer , respectively . The most common adverse events ( AEs ) were fatigue , nausea , and vomiting . Grade ≥ 3 AEs were reported for 54 % of patients ; anemia was the most common ( 17 % ) . CONCLUSION Responses to olaparib were observed across different tumor types associated with germline BRCA1/2 mutations . Olaparib warrants further investigation in confirmatory studies",
"PURPOSE Most patients with advanced ovarian cancer develop recurrent disease . For those patients who recur at least 6 months after initial therapy , paclitaxel platinum has shown a modest survival advantage over platinum without paclitaxel ; however , many patients develop clinical ly relevant neurotoxicity , frequently result ing in treatment discontinuation . Thus , an alternative regimen without significant neurotoxicity was evaluated by comparing gemcitabine plus carboplatin with single-agent carboplatin in platinum-sensitive recurrent ovarian cancer patients . METHODS Patients with platinum-sensitive recurrent ovarian cancer were r and omly assigned to receive either gemcitabine plus carboplatin or carboplatin alone , every 21 days . The primary objective was to compare progression-free survival ( PFS ) . RESULTS Three hundred fifty-six patients ( 178 gemcitabine plus carboplatin ; 178 carboplatin ) were r and omly assigned . Patients received a median of six cycles in both arms . With a median follow-up of 17 months , median PFS was 8.6 months ( 95 % CI , 7.9 to 9.7 months ) for gemcitabine plus carboplatin and 5.8 months ( 95 % CI , 5.2 to 7.1 months ) for carboplatin . The hazard ration ( HR ) for PFS was 0.72 ( 95 % CI , 0.58 to 0.90 ; P = .0031 ) . Response rate was 47.2 % ( 95 % CI , 39.9 % to 54.5 % ) for gemcitabine plus carboplatin and 30.9 % ( 95 % CI , 24.1 % to 37.7 % ) for carboplatin ( P = .0016 ) . The HR for overall survival was 0.96 ( 95 % CI , 0.75 to1.23 ; P = .7349 ) . While myelosuppression was significantly more common in the combination , sequelae such as febrile neutropenia or infections were uncommon . No statistically significant differences in quality of life scores between arms were noted . CONCLUSION Gemcitabine plus carboplatin significantly improves PFS and response rate without worsening quality of life for patients with platinum-sensitive recurrent ovarian cancer",
"BACKGROUND A dose-dense weekly schedule of paclitaxel ( result ing in a greater frequency of drug delivery ) plus carboplatin every 3 weeks or the addition of bevacizumab to paclitaxel and carboplatin administered every 3 weeks has shown efficacy in ovarian cancer . We proposed to determine whether dose-dense weekly paclitaxel and carboplatin would prolong progression-free survival as compared with paclitaxel and carboplatin administered every 3 weeks among patients receiving and those not receiving bevacizumab . METHODS We prospect ively stratified patients according to whether they elected to receive bevacizumab and then r and omly assigned them to receive either paclitaxel , administered intravenously at a dose of 175 mg per square meter of body-surface area every 3 weeks , plus carboplatin ( dose equivalent to an area under the curve [ AUC ] of 6 ) for six cycles or paclitaxel , administered weekly at a dose of 80 mg per square meter , plus carboplatin ( AUC , 6 ) for six cycles . The primary end point was progression-free survival . RESULTS A total of 692 patients were enrolled , 84 % of whom opted to receive bevacizumab . In the intention-to-treat analysis , weekly paclitaxel was not associated with longer progression-free survival than paclitaxel administered every 3 weeks ( 14.7 months and 14.0 months , respectively ; hazard ratio for disease progression or death , 0.89 ; 95 % confidence interval [ CI ] , 0.74 to 1.06 ; P=0.18 ) . Among patients who did not receive bevacizumab , weekly paclitaxel was associated with progression-free survival that was 3.9 months longer than that observed with paclitaxel administered every 3 weeks ( 14.2 vs. 10.3 months ; hazard ratio , 0.62 ; 95 % CI , 0.40 to 0.95 ; P=0.03 ) . However , among patients who received bevacizumab , weekly paclitaxel did not significantly prolong progression-free survival , as compared with paclitaxel administered every 3 weeks ( 14.9 months and 14.7 months , respectively ; hazard ratio , 0.99 ; 95 % CI , 0.83 to 1.20 ; P=0.60 ) . A test for interaction that assessed homogeneity of the treatment effect showed a significant difference between treatment with bevacizumab and without bevacizumab ( P=0.047 ) . Patients who received weekly paclitaxel had a higher rate of grade 3 or 4 anemia than did those who received paclitaxel every 3 weeks ( 36 % vs. 16 % ) , as well as a higher rate of grade 2 to 4 sensory neuropathy ( 26 % vs. 18 % ) ; however , they had a lower rate of grade 3 or 4 neutropenia ( 72 % vs. 83 % ) . CONCLUSIONS Overall , weekly paclitaxel , as compared with paclitaxel administered every 3 weeks , did not prolong progression-free survival among patients with ovarian cancer . ( Funded by the National Cancer Institute and Genentech ; GOG-0262 Clinical Trials.gov number , NCT01167712 . )"
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Decreasing levels of estrogens during menopause are associated with reduced bone density and an increased risk of osteoporosis . Many women also experience bothersome vasomotor and vaginal symptoms during the menopausal transition . Results of systematic review s and meta-analyses of r and omized controlled trials have shown that both systemic estrogen therapy or hormone therapy ( estrogen combined with a progestin ) are useful to prevent bone loss , and they are the most effective treatment for such climacteric symptoms as hot flushes , sweating , vaginal dryness , and dyspareunia . Unfortunately , estrogen therapy and hormone therapy increase the risk of endometrial and breast cancer , respectively . The selective estrogen receptor modulators ( SERMs ) result in positive estrogenic effects on bone , with no negative effects on the endometrium and breast but do not provide relief from postmenopausal symptoms . The combination of a SERM with estrogen as a tissue selective estrogen complex ( TSEC ) is a new strategy for the prevention of bone loss and the treatment of climacteric symptoms . This combination is particularly interesting from a clinical point of view , taking into account that estrogen alone did not increase breast cancer risk by the Women 's Health Initiative . TSEC is hypothesized to provide the benefits of estrogen-alone therapy , with an improved tolerability profile because the SERM component can make possible the elimination of progestin . The objective of this review was to critically evaluate the evidence from the reports published to date on the use of bazedoxifene ( a third-generation SERM ) in combination with conjugated estrogens in postmenopausal women . The conclusion is that effectively , the combination of bazedoxifene and conjugated estrogens may be a promising alternative to hormone therapy for the prevention of osteoporosis and the treatment of postmenopausal symptoms in non-hysterectomized postmenopausal women
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"Objective To describe the prevalence and treatment of hot flushes in premenopausal and postmenopausal women from the 1960s to the 1990s . Design This prospect i ve study , based on a r and om sample of the total female population of 430,000 in Gothenburg , Sweden , was started in 1968 , with follow-ups in 1974 , 1980 , and 1992 . The participants were 1,462 women born in 1930 , 1922 , 1918 , 1914 , and 1908 ( participation rate 90.1 % ) who were representative of women of the same age in the general population . For the purpose of analyzing secular trends , we included 122 participants who were 38 years old and 47 who were 50 years old in 1980–1981 . Results The prevalence of hot flushes increased from ∼11 % at 38 years to a maximal prevalence of ∼60 % at 52 to 54 years of age , then declined successively from ∼30 % at 60 years of age to ∼15 % at 66 years of age , and then to ∼9 % at 72 years of age . The predominant type of medication being prescribed changed during the observation period from sedatives/anticholinergic drugs in the 1960s to hormone replacement therapy in the 1980s . Hormone replacement therapy was considered to be an effective form of treatment for hot flushes by 70 % to 87 % of the women . Conclusions Hot flushes were a common symptom , with a maximal prevalence of 64 % at 54 years of age . Medical consultation and treatment did not increase in 50-year-old women from 1968–1969 to 1980–1981 . Treatment changed and became more effective during the observation period",
"Changes in the level of biochemical markers of bone resorption with risedronate treatment for osteoporosis were examined as a surrogate for the decrease in fracture risk . Greater decreases in bone resorption markers were associated with greater decreases in vertebral ( and nonvertebral ) fractures . Antifracture efficacy of antiresorptive therapies is only partially explained by increases in bone mineral density . Early decreases in bone resorption may also play a role . We tested this hypothesis by measuring two bone resorption markers , the C-telopeptide of type I collagen ( CTX ) and the N-telopeptide of type I collagen ( NTX ) , in osteoporotic patients in risedronate vertebral fracture trials . We studied 693 women with at least one vertebral deformity ( mean age , 69 + /- 7 years ) who received calcium ( and vitamin D if required ) and placebo or risedronate 5 mg daily for 3 years . The reductions in urinary CTX ( median , 60 % ) and NTX ( 51 % ) at 3 - 6 months with risedronate therapy were significantly associated ( p vertebral fracture risk ( 75 % over 1 year and 50 % over 3 years ) . The changes in both CTX and NTX accounted for approximately one-half ( CTX , 55 % ; NTX , 49 % ) of risedronate 's effect in reducing the risk of vertebral fractures in the first year and approximately two-thirds ( CTX , 67 % ; NTX , 66 % ) over 3 years compared with placebo . The changes in CTX and NTX accounted for 77 % and 54 % , respectively , of risedronate 's effect in reducing the risk of nonvertebral fractures over 3 years compared with placebo . The relationships between vertebral fracture risk and changes from baseline in CTX and NTX were not linear ( p fracture benefit below a decrease of 55 - 60 % for CTX and 35 - 40 % for NTX . The decrease in bone resorption in patients taking risedronate accounts for a large proportion of the reduction in fracture risk . There may be a level of bone resorption reduction below which there is no further fracture benefit",
" A telephone survey of a r and om sample of 594 perimenopausal women was done to study the prevalence of hot flashes , use of estrogen , age of menopause onset , and , among those subjects experiencing hot flashes , the frequency of occurrence and number of years of hot flashes . The prevalence of hot flashes was 88 % . Surgical menopause women had a prevalence rate of 92 % and had the highest estrogen utilization rate . The median age of onset for natural menopause women was 49 years . The frequency of occurrence and number of years of hot flash experience was variable across all groups",
"The transdermal and oral administration of estrogens for one year were compared with respect to the effects on lipid metabolism . Eighty-one postmenopausal women ( 1.5 - 3 years after menopause ) were r and omly divided into three groups . The first two groups received sequential estrogen treatment with either transdermal estradiol ( Estraderm TTS , Ciba Geigy ; 50 micrograms/day ; 24 women ) or 0.625 mg/day conjugated estrogens ( Premarin , Wyeth ; 20 subjects ) , respectively . In both groups medroxyprogesterone ( 10 mg/day per os ) was added for 12 days of each cycle . Thirty-five subjects served as control group without therapy . No significant changes in the lipid profile was observed in control subjects after 1 year of follow-up . Serum triglycerides decreased significantly ( -10.9 + /- 26 % S.D. ; P transdermal treated women , whereas it slightly rose in oral estrogen group . Comparable significant decreases in total and low density lipoprotein ( LDL ) cholesterol ( mean range -6.5/-18.0 % ) were observed in women on estrogen replacement therapy . High density lipoprotein ( HDL ) cholesterol significantly diminished in transdermal estradiol group , but it rose slightly in the oral estrogen group . Thus the fraction of HDL cholesterol over LDL cholesterol did not change in the transdermal group whereas it significantly rose in subjects treated with oral estrogens . It remains to be established to what extent these differences on lipid metabolism are relevant for the prevention of cardiovascular diseases",
"UNLABELLED We used data from the Fracture Intervention Trial to assess the relationship change in bone turnover after 1 year of alendronate or placebo treatment and subsequent hip , non-spine , and spine fracture risk among 6186 postmenopausal women . In the alendronate group ( n = 3105 ) , greater reductions in one or more biochemical marker were associated with a lower risk of fracture . INTRODUCTION There are few data on the relationship between short-term change in biochemical markers of bone turnover and non-spine fracture risk among bisphosphonate-treated women , and the clinical use of such measurements is unknown . MATERIAL S AND METHODS We measured biochemical markers of bone turnover ( bone-specific alkaline phosphatase [ bone ALP ] , intact N-terminal propeptide of type I collagen , and C-terminal crosslinked telopeptide of type 1 collagen ) and BMD of the spine and hip at baseline and after 1 year of alendronate or placebo . During a mean follow-up of 3.6 years , 72 hip , 786 non-spine , and 336 vertebral fractures were documented . RESULTS AND CONCLUSIONS Each 1 SD reduction in 1-year change in bone ALP was associated with fewer spine ( odds ratio = 0.74 ; CI : 0.63 , 0.87 ) , non-spine ( relative hazard [ RH ] = 0.89 ; CI : 0.78 , 1.00 ; p hip fractures ( RH = 0.61 ; CI : 0.46 , 0.78 ) . Alendronate-treated women with at least a 30 % reduction in bone ALP had a lower risk of non-spine ( RH = 0.72 ; CI : 0.55 , 0.92 ) and hip fractures ( RH = 0.26 ; CI : 0.08 , 0.83 ) relative to those with reductions alendronate therapy are associated with fewer hip , non-spine , and vertebral fractures , and the effect is at least as strong as that observed with 1-year change in BMD",
"OBJECTIVE To survey the prevalence of 18 menopausal symptoms in nine ethnic groups of Asian women . To evaluate responsiveness of symptoms to three estrogen/progestin doses in Asian women . DESIGN A prospect i ve , r and omized , double-blind multinational clinical trial in 1028 healthy postmenopausal women from 11 Asian countries/regions . Following 2 weeks of baseline observations , the women received one of three conjugated estrogens (CE)/medroxyprogesterone acetate ( MPA ) doses ( in mg ) daily for 24 weeks : 0.625/2.5 ; 0.45/1.5 ; or 0.3/1.5 . At baseline and throughout the study period , the women were asked to record each symptom daily on diary cards translated into 10 language s. RESULTS The number of women in the different ethnic groups ranged from 24 ( Malay ) to 248 ( Chinese ) . The overall prevalence of symptoms differed among the groups , with Vietnamese women generally reporting the highest rates . Within each ethnic group , the prevalence of individual symptoms varied substantially . Only 5 % of Indonesian women , for example , reported hot flushes but 93 % complained of body or joint aches/pains . Overall , body or joint aches/pains was the most prevalent symptom , ranging from 76 % in Korean women to 96 % in Vietnamese women . Therapy result ed in a significant decline in all symptoms . The decline was observed with all three doses after 4 weeks of treatment and continued throughout the 6-month study period . CONCLUSION The prevalence of individual menopausal symptoms differed among ethnic groups of Asian women . Within each ethnic group the percentage of women reporting each symptom varied substantially . Symptoms declined after 4 weeks of hormone therapy and thereafter throughout the study . The effect of the lowest dose of CE/MPA ( 0.3/1.5 mg/day ) was comparable to that of the higher doses",
"Objective To evaluate the effects of the tissue selective estrogen complex ( TSEC ) pairing bazedoxifene ( BZA ) with conjugated estrogens ( CE ) on sexual function and quality of life in postmenopausal women . Methods In this 12-week , double-blind , placebo-controlled study , postmenopausal , non-hysterectomized women ( n = 652 ) with symptoms of moderate to severe vulvar/vaginal atrophy were r and omized to once-daily treatment with BZA 20 mg/CE 0.45 or 0.625 mg , BZA 20 mg , or placebo . The Arizona Sexual Experiences ( ASEX ) Scale , Menopause-Specific Quality of Life ( MENQOL ) question naire , and Menopause Symptoms Treatment Satisfaction Question naire ( MS-TSQ ) were secondary measures used to assess the effects of BZA/CE on sexual function , menopausal symptoms , and satisfaction with treatment , respectively . Results At week 12 , both BZA/CE doses were associated with significant improvement in ease of lubrication score from baseline compared with placebo ( p MENQOL question naire results at week 12 showed significant improvements in vasomotor function , sexual function and total scores with both BZA/CE doses vs. placebo or BZA 20 mg ( p overall satisfaction with treatment , as well as satisfaction with control of hot flushes during the day and night , effect on quality of sleep , and effect on mood or emotions , compared with subjects treated with placebo or BZA 20 mg ( all p BZA/CE for 12 weeks was shown to significantly improve sexual function and quality -of-life measures in symptomatic postmenopausal women",
"OBJECTIVE To determine the relation between estrogen replacement therapy and fractures . DESIGN Prospect i ve cohort study . SETTING Four clinical centers in Baltimore County , Maryl and ; Minneapolis , Minnesota ; Portl and , Oregon ; and the Monongahela Valley , Pennsylvania . PARTICIPANTS 9704 ambulatory , nonblack women 65 years of age or older . MEASUREMENTS Estrogen use , medical history , and anthropometric data were obtained by question naire , interview , and examination . Appendicular bone mass was measured by single-photon absorptiometry . Incident fractures were vali date d by radiographic report . RESULTS After adjustment for potential confounders , current estrogen use was associated with a decrease in the risk for wrist fractures ( relative risk [ RR ] , 0.39 ; 95 % CI , 0.24 to 0.64 ) and for all nonspinal fractures ( RR , 0.66 ; CI , 0.54 to 0.80 ) when compared with no estrogen use . Results were similar for women using unopposed estrogen or estrogen plus progestin , for women younger or older than 75 years of age , and for current smokers or nonsmokers . The effect of estrogen remained after adjustment was made for appendicular bone mass . The relative risk for hip fracture tended to be lower among current users ( RR , 0.60 ; CI , 0.36 to 1.02 ) than among never-users . Estrogen was most effective in preventing hip fracture among those older than 75 years . Current users who started estrogen within 5 years of menopause had a decreased risk for hip fractures ( RR , 0.29 ; CI , 0.09 to 0.92 ) , wrist fractures ( RR , 0.29 ; CI , 0.13 to 0.68 ) , and all nonspinal fractures ( RR , 0.50 ; CI , 0.36 to 0.70 ) when compared with women who had never used estrogen . Previous use of estrogen for more than 10 years or use begun soon after menopause had no substantial effect on the risk for fractures . CONCLUSIONS Current use of estrogen appears to decrease the risk for fracture in older women . These results suggest that for protection against fractures , estrogen should be initiated soon after menopause and continued indefinitely",
"CONTEXT Despite decades of accumulated observational evidence , the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain . OBJECTIVE To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States . DESIGN Estrogen plus progestin component of the Women 's Health Initiative , a r and omized controlled primary prevention trial ( planned duration , 8.5 years ) in which 16608 postmenopausal women aged 50 - 79 years with an intact uterus at baseline were recruited by 40 US clinical centers in 1993 - 1998 . INTERVENTIONS Participants received conjugated equine estrogens , 0.625 mg/d , plus medroxyprogesterone acetate , 2.5 mg/d , in 1 tablet ( n = 8506 ) or placebo ( n = 8102 ) . MAIN OUTCOMES MEASURES The primary outcome was coronary heart disease ( CHD ) ( nonfatal myocardial infa rct ion and CHD death ) , with invasive breast cancer as the primary adverse outcome . A global index summarizing the balance of risks and benefits included the 2 primary outcomes plus stroke , pulmonary embolism ( PE ) , endometrial cancer , colorectal cancer , hip fracture , and death due to other causes . RESULTS On May 31 , 2002 , after a mean of 5.2 years of follow-up , the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits . This report includes data on the major clinical outcomes through April 30 , 2002 . Estimated hazard ratios ( HRs ) ( nominal 95 % confidence intervals [ CIs ] ) were as follows : CHD , 1.29 ( 1.02 - 1.63 ) with 286 cases ; breast cancer , 1.26 ( 1.00 - 1.59 ) with 290 cases ; stroke , 1.41 ( 1.07 - 1.85 ) with 212 cases ; PE , 2.13 ( 1.39 - 3.25 ) with 101 cases ; colorectal cancer , 0.63 ( 0.43 - 0.92 ) with 112 cases ; endometrial cancer , 0.83 ( 0.47 - 1.47 ) with 47 cases ; hip fracture , 0.66 ( 0.45 - 0.98 ) with 106 cases ; and death due to other causes , 0.92 ( 0.74 - 1.14 ) with 331 cases . Corresponding HRs ( nominal 95 % CIs ) for composite outcomes were 1.22 ( 1.09 - 1.36 ) for total cardiovascular disease ( arterial and venous disease ) , 1.03 ( 0.90 - 1.17 ) for total cancer , 0.76 ( 0.69 - 0.85 ) for combined fractures , 0.98 ( 0.82 - 1.18 ) for total mortality , and 1.15 ( 1.03 - 1.28 ) for the global index . Absolute excess risks per 10 000 person-years attributable to estrogen plus progestin were 7 more CHD events , 8 more strokes , 8 more PEs , and 8 more invasive breast cancers , while absolute risk reductions per 10 000 person-years were 6 fewer colorectal cancers and 5 fewer hip fractures . The absolute excess risk of events included in the global index was 19 per 10 000 person-years . CONCLUSIONS Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy postmenopausal US women . All-cause mortality was not affected during the trial . The risk-benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases , and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD",
"ABSTRACT Objectives Bazedoxifene/conjugated estrogens ( BZA/CE ) has demonstrated efficacy in improving vasomotor and vulvar/vaginal atrophy symptoms in postmenopausal women . This study evaluated the endometrial safety of BZA/CE and effects on bone mineral density ( BMD ) compared with CE/medroxyprogesterone acetate ( MPA ) and placebo . Methods The Selective estrogens , Menopause , And Response to Therapy (SMART)-4 trial was a 1-year , multicenter , double-blind , r and omized , placebo– and active-controlled , phase-3 study in non-hysterectomized , postmenopausal women ( n = 1061 ; aged 40 − Subjects received BZA 20 mg/CE 0.45 or 0.625 mg , CE 0.45 mg/MPA 1.5 mg , or placebo daily . Primary endpoints were the incidence of endometrial hyperplasia and the change in lumbar spine BMD at 1 year . Secondary endpoints included the change in total hip BMD and rates of amenorrhea and breast pain . Results At 1 year , no cases of endometrial hyperplasia were identified in the BZA 20-mg/CE 0.45-mg group , while three cases ( 1.1 % ) were confirmed for the BZA 20-mg/CE 0.625-mg group ( 95 % one-sided confidence interval upper limit BZA/CE doses significantly increased lumbar spine and total hip BMD versus placebo ( p ≤ 0.001 ) and showed low incidences of bleeding and breast tenderness , similar to placebo and significantly lower than for CE 0.45 mg/MPA 1.5 mg ( p . BZA/CE treatment was generally safe and well tolerated . Conclusions BZA 20 mg/CE 0.45 and 0.625 mg significantly improved BMD while maintaining endometrial safety and showed a favorable safety/tolerability profile over 1 year . BZA/CE may be a promising therapy for treating menopausal symptoms and preventing osteoporosis in non-hysterectomized , postmenopausal women",
"OBJECTIVE To evaluate the efficacy of lower doses of conjugated equine estrogens ( CEE ) plus medroxyprogesterone acetate ( MPA ) for relieving vasomotor symptoms and vaginal atrophy . DESIGN A r and omized , double-blind , placebo-controlled trial ( the Women 's Health , Osteoporosis , Progestin , Estrogen study ) . SETTING Study centers across the United States . PATIENT(S ) Two thous and , six hundred , seventy-three healthy , postmenopausal women with an intact uterus , including an efficacy-evaluable population ( n = 241 at baseline ) . INTERVENTION(S ) Patients received for 1 year ( 13 cycles ; in milligrams per day ) CEE , 0.625 ; CEE , 0.625 and MPA , 2.5 ; CEE , 0.45 ; CEE , 0.45 and MPA , 2.5 ; CEE , 0.45 and MPA , 1.5 ; CEE , 0.3 ; CEE , 0.3 and MPA , 1.5 ; or placebo . MAIN OUTCOME MEASURE(S ) Number and severity of hot flushes and Papanicolaou smear with vaginal maturation index ( VMI ) to assess vaginal atrophy . RESULT ( S ) In the efficacy-evaluable population , reduction in vasomotor symptoms was similar with CEE of 0.625 mg/d and MPA of 2.5 mg/d ( the most commonly prescribed doses ) and all lower combination doses . CEE of 0.625 mg/d alleviated hot flushes more effectively than the lower doses of CEE alone . VMI improved in all active treatment groups . CONCLUSION ( S ) Lower doses of CEE plus MPA relieve vasomotor symptoms and vaginal atrophy as effectively as commonly prescribed doses",
"In this 3-yr , r and omized , double-blind , placebo- and active-controlled study , healthy postmenopausal women with osteoporosis ( 55 - 85 yr of age ) were treated with bazedoxifene 20 or 40 mg/d , raloxifene 60 mg/d , or placebo . The primary endpoint was incidence of new vertebral fractures after 36 mo ; secondary endpoints included nonvertebral fractures , BMD , and bone turnover markers . Among 6847 subjects in the intent-to-treat population , the incidence of new vertebral fractures was significantly lower ( p bazedoxifene 20 mg ( 2.3 % ) , bazedoxifene 40 mg ( 2.5 % ) , and raloxifene 60 mg ( 2.3 % ) compared with placebo ( 4.1 % ) , with relative risk reductions of 42 % , 37 % , and 42 % , respectively . The treatment effect was similar among subjects with or without prevalent vertebral fracture ( p = 0.89 for treatment by baseline fracture status interaction ) . The incidence of nonvertebral fractures with bazedoxifene or raloxifene was not significantly different from placebo . In a posthoc analysis of a subgroup of women at higher fracture risk ( femoral neck T-score or=1 moderate or severe vertebral fracture or multiple mild vertebral fractures ; n = 1772 ) , bazedoxifene 20 mg showed a 50 % and 44 % reduction in nonvertebral fracture risk relative to placebo ( p = 0.02 ) and raloxifene 60 mg ( p = 0.05 ) , respectively . Bazedoxifene significantly improved BMD and reduced bone marker levels ( p incidence of vasodilatation , leg cramps , and venous thromboembolic events was higher with bazedoxifene and raloxifene compared with placebo . In conclusion , bazedoxifene significantly reduced the risk of new vertebral fracture in postmenopausal women with osteoporosis and decreased the risk of nonvertebral fracture in subjects at higher fracture risk",
"Summary In this 2-year extension of a 3-year study , bazedoxifene showed sustained efficacy in preventing new vertebral fractures in postmenopausal women with osteoporosis and in preventing non-vertebral fractures in higher-risk women . Bazedoxifene significantly increased bone mineral density and reduced bone turnover versus placebo and was generally safe and well tolerated . Introduction This study evaluated the efficacy and safety of bazedoxifene for the treatment of postmenopausal osteoporosis over 5 years . Methods A total of 4,216 postmenopausal women with osteoporosis were enrolled in this 2-year extension of a 3-year , r and omized , double-blind , placebo-controlled , phase 3 trial . In the core study ( N = 7,492 ) , subjects received bazedoxifene 20 or 40 mg/day , raloxifene 60 mg/day , or placebo . The raloxifene arm was discontinued after 3 years ; subjects receiving bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg after 4 years . Five-year findings are reported for bazedoxifene 20 and 40/20 mg and placebo . Endpoints included incidence of new vertebral fractures ( primary ) and non-vertebral fractures , and changes in bone mineral density ( BMD ) and bone turnover markers . Results At 5 years , the incidence of new vertebral fractures in the intent-to-treat population was significantly lower with bazedoxifene 20 mg ( 4.5 % ) and 40/20 mg ( 3.9 % ) versus placebo ( 6.8 % ; P respectively . Non-vertebral fracture incidence was similar among groups . In a subgroup of higher-risk women ( n = 1,324 ; femoral neck T-score ≤−3.0 and /or ≥1 moderate or severe or ≥2 mild vertebral fracture[s ] ) , bazedoxifene 20 mg reduced non-vertebral fracture risk versus placebo ( 37 % ; P = 0.06 ) ; combined data for bazedoxifene 20 and 40/20 mg reached statistical significance ( 34 % reduction ; P 0.05 ) . Bazedoxifene significantly increased BMD and reduced bone turnover versus placebo ( P safe and well tolerated . Conclusions The findings support a sustained anti-fracture effect of bazedoxifene on new vertebral fractures in postmenopausal osteoporotic women and on non-vertebral fractures in the higher-risk subgroup of women",
"UNLABELLED Osteoporosis is an increasingly common health concern in postmenopausal women . In a 2-yr phase III study , bazedoxifene prevented bone loss , reduced bone turnover , and was well tolerated in early postmenopausal women with normal or low BMD . INTRODUCTION Bazedoxifene is a novel selective estrogen receptor modulator that has increased BMD and bone strength in experimental models , without stimulating breast or uterus . This 24-mo , r and omized , double-blind study assessed the efficacy and safety of three doses of bazedoxifene compared with placebo and raloxifene in the prevention of postmenopausal osteoporosis . MATERIAL S AND METHODS Healthy postmenopausal women with a BMD T-score at the lumbar spine or femoral neck between -1.0 and -2.5 or clinical risk factors for osteoporosis were r and omly assigned to one of five groups : bazedoxifene 10 , 20 , or 40 mg/d , placebo , or raloxifene 60 mg/d . All women received elemental calcium . Efficacy outcomes included changes from baseline through 24 mo in BMD of the lumbar spine , hip , femoral neck , and femoral trochanter and biomarkers of bone metabolism . RESULTS The intent-to-treat population included 1434 women ( mean age , 58 yr ; mean time from last menstrual period , 11 yr ) . All doses of bazedoxifene and raloxifene prevented bone loss , whereas in the placebo group , there was significant loss of BMD at all skeletal sites . Mean differences in percent change in lumbar spine BMD from baseline to 24 mo relative to placebo were 1.08 + /- 0.28 % , 1.41 + /- 0.28 % , 1.49 + /- 0.28 % , and 1.49 + /- 0.28 % for 10 , 20 , and 40 mg bazedoxifene and 60 mg raloxifene , respectively ( p BMD responses were observed at other body sites . Significant and comparable decreases in serum osteocalcin and C-telopeptide levels from baseline and relative to placebo with active treatment were observed as early as 3 mo and were sustained through study conclusion ( p incidences of adverse events , serious adverse events , and discontinuations caused by adverse events were similar between groups . The most common adverse events included headache , infection , arthralgia , pain , hot flush , and back pain . CONCLUSIONS Treatment with bazedoxifene prevented bone loss and reduced bone turnover equally as well as raloxifene and was generally well tolerated in postmenopausal women with normal/low BMD",
"OBJECTIVE To evaluate the effect of bazedoxifene/conjugated estrogens ( BZA/CE ) , a tissue selective estrogen complex , on uterine bleeding in postmenopausal women . DESIGN International , multicenter , r and omized , double-blind , placebo- and active-controlled , phase III study ( Selective estrogen Menopause And Response to Therapy [SMART]-1 ) . SETTING Outpatient clinical . PATIENT(S ) Healthy , postmenopausal women ( N = 3,397 ) aged 40 to 75 years with an intact uterus . INTERVENTION(S ) Daily oral therapy with BZA 10 , 20 , or 40 mg , each with CE 0.625 or 0.45 mg , raloxifene 60 mg , or placebo . MAIN OUTCOME MEASURE(S ) Cumulative amenorrhea profiles and the incidence of bleeding or spotting over 2 years . RESULT ( S ) Treatment with BZA 20 or 40 mg with CE 0.625 or 0.45 mg was associated with rates of cumulative amenorrhea ( > 83 % during cycles 1 - 13 and > 93 % during cycles 10 - 13 ) and bleeding or spotting that were comparable to those with placebo . Subjects who received BZA 10 mg/CE 0.625 mg experienced slightly lower cumulative amenorrhea rates throughout the study compared with placebo-treated subjects . CONCLUSION ( S ) Postmenopausal women treated with BZA 20 or 40 mg with CE 0.625 or 0.45 mg had high rates of cumulative amenorrhea that were similar to those reported with placebo . This new menopausal therapy may offer a favorable bleeding and tolerability profile",
"Abstract : For 285 subjects referred to a menopause clinic data were prospect ively collected on the time elapsed since the onset of menopause ( menopausal age ) , sexual activity , dyspareunia , smoking , chronic cough and constipation . Prolapse and atrophy were sought on examination . FSH assay confirmed menopausal status . We found an anterior wall prolapse in 51 % of the subjects , of which 6 % were protruding beyond the introitus . Posterior wall prolapse was present in 27 % and apical prolapse in 20 % ; none was protruding beyond the introitus . No trend was noted between prolapse and menopausal age . Atrophy was evident in 34 % of the women , and this was related to menopausal age ( P dyspareunia , of which 2/3 were superficial . This correlated with advancing menopausal age ( P genital prolapse was frequent in the population of postmenopausal women , predominantly cystocele , but the prevalence did not correlate with menopausal age",
"CONTEXT Lower-than-commonly-prescribed doses of conjugated equine estrogens ( CEEs ) with medroxyprogesterone acetate ( MPA ) improve vasomotor symptoms and vaginal atrophy , provide acceptable bleeding and lipid profiles , and afford endometrial protection . This lower-dose therapy 's protection against loss of bone mineral density ( BMD ) associated with menopause has not been thoroughly investigated . OBJECTIVE To determine the effects of lower doses of CEEs only or CEEs-MPA on spine and hip BMD , total body bone mineral content ( BMC ) , and biochemical markers of bone turnover in postmenopausal women . DESIGN AND SETTING Two-year r and omized , double-blind , placebo-controlled sub study of the Women 's Health , Osteoporosis , Progestin , Estrogen trial , conducted at 19 US centers between August 1995 and October 2000 . PARTICIPANTS Eight hundred twenty-two healthy postmenopausal women aged 40 to 65 years who were within 4 years of their last menstrual period . INTERVENTIONS Patients were r and omly assigned to receive CEEs , 0.625 ; CEEs , 0.625 and MPA , 2.5 ; CEEs , 0.45 ; CEEs , 0.45 and MPA , 2.5 ; CEEs , 0.45 and MPA , 1.5 ; CEEs , 0.3 ; CEEs 0.3 and MPA , 1.5 ( all doses in mg/d ) ; or placebo for 2 years . All participants also received elemental calcium at 600 mg/d . MAIN OUTCOME MEASURES Changes from baseline in spine and total hip BMD , total body BMC , and biochemical markers of bone turnover ( serum osteocalcin and urinary cross-linked N-telopeptides of type I collagen ) , assessed at 6-month intervals and compared among treatment groups with a modified intention-to-treat approach . RESULTS At 24 months , women assigned to all of the active treatment groups had significant gains from baseline ( P spine and hip BMD and total body BMC ( except total body BMC in the group receiving CEEs , 0.3 mg/d ) . These changes were significantly different from those in the placebo group , in which losses of bone mass in spine and total body were evident over the course of the study ( P loss in hip BMD from baseline in the placebo group was significant at 18 ( P = .02 ) but not at 24 months ( P = .06 ) . Osteocalcin and N-telopeptides of type I collagen were significantly reduced from baseline ( P placebo group . For women treated with CEEs alone , the gains in spine BMD for the group taking CEEs , 0.625 mg/d , were significantly higher than those of the group taking CEEs , 0.3 mg/d ( P = .02 ) , but not the group treated with CEEs , 0.45 mg/d ( P = .48 ) . CONCLUSIONS Doses of CEEs or CEEs-MPA lower than 0.625 mg/d effectively increase BMD and BMC in early postmenopausal women",
"Objective : Phase 3 studies of postmenopausal women with or at risk for osteoporosis reported that , compared with placebo , bazedoxifene increased the incidence of hot flushes . The current study evaluated the vasomotor effects of bazedoxifene in healthy nonflushing postmenopausal women . Methods : In this phase 2 study , nonflushing postmenopausal women ( n = 494 ) were r and omized to daily treatment with bazedoxifene 5 , 10 , or 20 mg ; raloxifene 60 mg ; or placebo for 12 weeks . The primary endpoint was the percentage of women reporting hot flushes at any time during the study ; secondary endpoints included the mean number and severity of hot flushes and the mean number of days with hot flushes . Effects on bone turnover markers and lipid parameters were also evaluated . Results : Over the 12-week study , 25.5 % of placebo-treated women reported hot flushes . The incidence of hot flushes with bazedoxifene 5 , 10 , and 20 mg and raloxifene 60 mg was 26.0 % , 33.7 % , 27.6 % , and 21.4 % , respectively , with no significant differences from that with placebo . The active treatment groups showed no significant differences from placebo in the mean number or severity of hot flushes during week 12 or any 4-week period . Bazedoxifene and raloxifene showed beneficial effects on lipid parameters and markers of bone turnover . All doses of bazedoxifene were generally well tolerated and did not increase endometrial thickness , vaginal bleeding , or breast pain compared with placebo over 12 weeks of therapy . Conclusions : Data from this phase 2 clinical trial suggest that bazedoxifene does not increase the incidence of hot flushes relative to placebo in nonflushing postmenopausal women",
"CONTEXT Despite decades of use and considerable research , the role of estrogen alone in preventing chronic diseases in postmenopausal women remains uncertain . OBJECTIVE To assess the effects on major disease incidence rates of the most commonly used postmenopausal hormone therapy in the United States . DESIGN , SETTING , AND PARTICIPANTS A r and omized , double-blind , placebo-controlled disease prevention trial ( the estrogen-alone component of the Women 's Health Initiative [ WHI ] ) conducted in 40 US clinical centers beginning in 1993 . Enrolled were 10 739 postmenopausal women , aged 50 - 79 years , with prior hysterectomy , including 23 % of minority race/ethnicity . INTERVENTION Women were r and omly assigned to receive either 0.625 mg/d of conjugated equine estrogen ( CEE ) or placebo . MAIN OUTCOME MEASURES The primary outcome was coronary heart disease ( CHD ) incidence ( nonfatal myocardial infa rct ion or CHD death ) . Invasive breast cancer incidence was the primary safety outcome . A global index of risks and benefits , including these primary outcomes plus stroke , pulmonary embolism ( PE ) , colorectal cancer , hip fracture , and deaths from other causes , was used for summarizing overall effects . RESULTS In February 2004 , after review ing data through November 30 , 2003 , the National Institutes of Health ( NIH ) decided to end the intervention phase of the trial early . Estimated hazard ratios ( HRs ) ( 95 % confidence intervals [ CIs ] ) for CEE vs placebo for the major clinical outcomes available through February 29 , 2004 ( average follow-up 6.8 years ) , were : CHD , 0.91 ( 0.75 - 1.12 ) with 376 cases ; breast cancer , 0.77 ( 0.59 - 1.01 ) with 218 cases ; stroke , 1.39 ( 1.10 - 1.77 ) with 276 cases ; PE , 1.34 ( 0.87 - 2.06 ) with 85 cases ; colorectal cancer , 1.08 ( 0.75 - 1.55 ) with 119 cases ; and hip fracture , 0.61 ( 0.41 - 0.91 ) with 102 cases . Corresponding results for composite outcomes were : total cardiovascular disease , 1.12 ( 1.01 - 1.24 ) ; total cancer , 0.93 ( 0.81 - 1.07 ) ; total fractures , 0.70 ( 0.63 - 0.79 ) ; total mortality , 1.04 ( 0.88 - 1.22 ) , and the global index , 1.01 ( 0.91 - 1.12 ) . For the outcomes significantly affected by CEE , there was an absolute excess risk of 12 additional strokes per 10 000 person-years and an absolute risk reduction of 6 fewer hip fractures per 10 000 person-years . The estimated excess risk for all monitored events in the global index was a nonsignificant 2 events per 10 000 person-years . CONCLUSIONS The use of CEE increases the risk of stroke , decreases the risk of hip fracture , and does not affect CHD incidence in postmenopausal women with prior hysterectomy over an average of 6.8 years . A possible reduction in breast cancer risk requires further investigation . The burden of incident disease events was equivalent in the CEE and placebo groups , indicating no overall benefit . Thus , CEE should not be recommended for chronic disease prevention in postmenopausal women",
"Objectives : The primary objective of the Selective estrogen Menopause And Response to Therapy 3 ( SMART-3 ) trial was to compare the efficacy and safety of two doses of bazedoxifene (BZA)/conjugated estrogens ( CE ) versus placebo for the treatment of moderate to severe vulvar/vaginal atrophy ( VVA ) associated with menopause . Methods : This was a phase 3 , multicenter , double-blind , r and omized , placebo-controlled , and active comparator-controlled study . Healthy postmenopausal women ( n = 664 ; aged 40 - 65 y ) were r and omized to BZA 20 mg/CE 0.625 mg , BZA 20 mg/CE 0.45 mg , BZA 20 mg , or placebo once daily for 12 weeks . Changes in vaginal maturation , vaginal pH , and severity of the most bothersome symptom of VVA from baseline were assessed at screening and at weeks 4 and 12 . Adverse events were recorded throughout the study . Results : BZA 20 mg/CE 0.625 or CE 0.45 mg significantly ( P superficial cells and decreased parabasal cells compared with placebo . Vaginal pH and most bothersome symptom significantly improved with BZA 20 mg/CE 0.625 mg compared with placebo ( P vaginal dryness were also observed with both BZA/CE doses ( P adverse events were similar across treatment groups . Conclusions : BZA/CE is effective in treating moderate to severe VVA and vaginal symptoms . These data further support the use of a tissue-selective estrogen complex containing BZA/CE as a new menopausal therapy for postmenopausal women",
"OBJECTIVE To assess the effects of bazedoxifene/conjugated estrogens ( BZA/CE ) on sleep parameters and health-related quality of life ( HR-QOL ) . METHODS This was a 12-week , multicenter , double-blind , placebo-controlled phase 3 study . Postmenopausal women with an intact uterus and experiencing > or=7 moderate-to-severe hot flushes daily were r and omized to BZA 20 mg/CE 0.45 mg , BZA 20 mg/CE 0.625 mg , or placebo . In these secondary efficacy analyses , the Medical Outcomes Study ( MOS ) sleep scale and Menopause-Specific Quality of Life ( MENQOL ) question naires and the Menopause Symptoms Treatment Satisfaction Question naire ( MS-TSQ ) evaluated measures of sleep , menopausal symptoms , and satisfaction with treatment , respectively . RESULTS A total of 318 subjects ( mean age , 53.4 years ) received > or=1 dose of study drug . At Week 12 , BZA 20 mg/CE 0.45 and 0.625 mg showed significant improvements over placebo in the MOS sleep scale for time to fall asleep , sleep adequacy , sleep disturbance , and sleep problems indexes I and II ( P hot flush frequency was significantly associated with improvement in sleep parameters ( P vasomotor function and total MENQOL score ( P satisfaction with treatment ( P satisfaction with sleep quality , ability to control hot flushes during the day and night , effect on mood/emotions , and tolerability . CONCLUSION Symptomatic postmenopausal women treated with BZA/CE experienced significant improvements in sleep parameters and overall HR-QOL",
"OBJECTIVE To evaluate the efficacy of the tissue-selective estrogen complex , bazedoxifene/conjugated estrogens ( BZA/CE ) , for postmenopausal osteoporosis prevention . DESIGN Multicenter , r and omized , double-blind , placebo- and active-controlled , phase 3 trial ( Selective estrogen Menopause And Response to Therapy [SMART]-1 ) . SETTING Outpatient clinical study . PATIENT(S ) Women ( n = 3,397 ) more than 5 years and 1 - 5 years postmenopause were enrolled in the Osteoporosis Prevention I and II Sub studies , respectively . INTERVENTION(S ) Single tablets of BZA ( 10 , 20 , or 40 mg ) each with CE ( 0.625 or 0.45 mg ) , raloxifene ( 60 mg ) , or a placebo taken daily for 2 years . MAIN OUTCOME MEASURE(S ) The primary outcome for both sub studies was change in bone mineral density of the lumbar spine ; bone mineral density was also measured at the hip . RESULT ( S ) In both sub studies , bone mineral density increased significantly more with all BZA/CE doses compared with placebo at the lumbar spine and total hip , and for most BZA/CE doses compared with raloxifene at the lumbar spine . Osteocalcin and N-telopeptide significantly decreased with all BZA/CE doses vs. placebo and most BZA/CE doses vs. raloxifene . CONCLUSION ( S ) BZA/CE combinations decreased bone turnover and bone loss in postmenopausal women at increased risk for osteoporosis",
"In this study we examine the influence of number of years since menopause on spontaneous bone loss and response to hormone replacement therapy ( HRT ) in 274 women ( 56.1 + /- 4.2 years ) completing two placebo-controlled HRT studies of 2 or 3 year duration . Both cross sectionally and longitudinally , bone loss in untreated women was greatest closest to menopause and declined thereafter ( r = 0.34 , p bone loss when correlated with number of years since menopause ) , such that the loss was eliminated in the femoral neck and bone mass increased in the spine in women > 10 years after menopause . In contrast , bone turnover was consistently elevated throughout postmenopause , both cross-sectionally and longitudinally . The association with number of years since menopause was counteracted by both 1 and 2 mg estradiol combined with gestodene , piperazine , estrone sulfate in combination with norethisterone , and a combination of 2 mg estradiol and 1 mg norethisterone acetate . In addition , the response to various HRT regimens was independent of baseline bone mass . Whereas bone loss was significantly related to number of years since menopause , all HRT regimens applied arrested bone loss in healthy postmenopausal women , regardless of number of years since menopause",
"Objective : The aim of this study was to examine the endometrial , ovarian , and breast safety of bazedoxifene , a novel selective estrogen-receptor modulator , in postmenopausal women at risk for osteoporosis . Methods : Healthy postmenopausal women ( N = 1,583 ; mean age , 57.6 y ) with lumbar spine or femoral neck bone mineral density T scores between −1 and −2.5 and /or other clinical risk factors for osteoporosis were enrolled in a 24-month , phase 3 , r and omized , double-blind , placebo- and active-controlled trial . They received daily treatment with bazedoxifene 10 , 20 , or 40 mg ; placebo ; or raloxifene 60 mg . Reproductive safety assessment s included periodic transvaginal ultrasound measurements of endometrial thickness , ovarian volume , and presence of ovarian cysts ; periodic endometrial biopsies ; and adverse event reporting . Results : Bazedoxifene was not associated with a significant change from baseline in mean endometrial thickness at month 24 . The percentage of participants with a change from baseline in endometrial thickness or endometrial thickness greater than 5 mm at month 24 was similar among groups . There was no consensus diagnosis of endometrial hyperplasia or malignancy in the bazedoxifene or raloxifene groups ; the rates of other histologic findings , including endometrial polyps , were low ( in ovarian volume , number or size of ovarian cysts , or incidence of ovarian cancer . Reports of breast pain ( and breast cancer ( bazedoxifene in healthy , recently postmenopausal women at risk for osteoporosis",
"OBJECTIVES To assess the extent to which prior hormone therapy modifies the breast cancer risk found with estrogen plus progestin ( E+P ) in the Women 's Health Initiative ( WHI ) r and omized trial . METHODS Subgroup analyses of prior hormone use on invasive breast cancer incidence in 16,608 postmenopausal women in the WHI r and omized trial of E+P over an average 5.6 years of follow-up . RESULTS Small but statistically significant differences were found between prior HT users and non-users for most breast cancer risk factors but Gail risk scores were similar . Duration of E+P use within the trial ( mean 4.4 years , S.D. 2.0 ) did not vary by prior use . Among 4311 prior users , the adjusted hazard ratio ( HR ) for E+P versus placebo was 1.96 ( 95 % confidence interval [ CI ] : 1.17 - 3.27 ) , significantly different ( p=0.03 ) from that among 12,297 never users ( HR 1.02 ; 95 % CI : 0.77 - 1.36 ) . The interaction between study arm and follow-up time was significant overall ( p=0.01 ) and among never users ( p=0.02 ) but not among prior users ( p=0.10 ) . The cumulative incidence over time for the E+P and placebo groups appeared to cross after about 3 years in prior users , and after about 5 years in women with no prior use . No interaction was found with duration ( p=0.08 ) or recency of prior use ( p=0.17 ) . Prior hormone use significantly increased the E+P hazard ratio for larger , more advanced tumors . CONCLUSION A safe interval for combined hormone use could not be reliably defined with these data . However , the significant increase in breast cancer risk in the trial overall after only 5.6 years of follow-up , initially concentrated in women with prior hormone exposure , but with increasing risk over time in women without prior exposure , suggests that duration s only slightly longer than those in the WHI trial are associated with increased risk of breast cancer . Longer-term exposure and follow-up data are needed",
"Objective : The aim of this study was to assess the safety and efficacy of bazedoxifene (BZA)/conjugated estrogens ( CE ) treating moderate to severe vasomotor symptoms in the Selective Estrogen Menopause and Response to Therapy 2 trial . Methods : This was an outpatient , multicenter , double-blind , r and omized , placebo-controlled , phase 3 study conducted in the United States . Healthy postmenopausal women ( N = 332 ; aged 40 - 65 y ) with moderate to severe hot flushes ( ≥7/d or 50/wk ) were r and omized to BZA 20 mg/CE 0.45 mg , BZA 20 mg/CE 0.625 mg , or placebo once daily for 12 weeks . Changes from baseline in the average daily number of moderate and severe hot flushes and daily severity score were assessed at weeks 4 and 12 ; adverse events were recorded . Results : BZA/CE significantly reduced the number and severity of hot flushes at weeks 4 and 12 ( P reduced hot flushes from baseline by 74 % ( 10.3 hot flushes [ baseline ] vs 2.8 [ week 12 ] ) and 80 % ( 10.4 vs 2.4 ) , respectively , compared with 51 % ( 10.5 vs 5.4 ) for placebo . More participants at week 12 had at least a 75 % decrease in hot flushes with BZA 20 mg/CE 0.45 mg ( 61 % ) and BZA 20 mg/CE 0.625 mg ( 73 % ) versus placebo ( 27 % ; P The safety profile was similar between BZA/CE and placebo , and no unexpected safety findings were reported . Conclusions : BZA 20 mg paired with CE 0.45 or 0.625 mg is effective , with short-term safety , for treating vasomotor symptoms in postmenopausal women",
"OBJECTIVE To evaluate the endometrial safety of a tissue selective estrogen complex ( TSEC ; pairing of a selective estrogen receptor modulator [ SERM ] with estrogens ) composed of bazedoxifene/conjugated estrogens ( BZA/CE ) in postmenopausal women . DESIGN R and omized , double-blind , multicenter , placebo- and active-controlled , phase 3 study ( Selective estrogen Menopause And Response to Therapy [SMART]-1 ) . SETTING Outpatient clinical . PATIENT(S ) Healthy , postmenopausal women ( n = 3,397 ) age 40 - 75 with an intact uterus . INTERVENTION(S ) Single tablets of BZA ( 10 , 20 , or 40 mg ) combined with CE ( 0.625 or 0.45 mg ) ; raloxifene ( 60 mg ) ; or placebo daily for 2 years . MAIN OUTCOME MEASURE(S ) Incidence of endometrial hyperplasia at 12 months in the efficacy evaluable population . RESULT ( S ) Treatment with BZA ( 20 or 40 mg)/CE ( 0.625 or 0.45 mg ) was associated with low rates ( endometrial hyperplasia that were not significantly different from those reported with placebo over 24 months . Endometrial thickness with BZA ( 20 or 40 mg)/CE ( 0.625 or 0.45 mg ) was not significantly different from that with placebo . CONCLUSION ( S ) When combined with CE ( 0.625 mg or 0.45 mg ) , BZA ( 20 mg ) was the lowest effective dose that prevented endometrial hyperplasia over 2 years of study , creating the possibility for a new , progestin-free menopausal therapy"
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BACKGROUND Results of r and omised controlled trials ( RCTs ) of vitamin D supplementation to improve bone density in children are inconsistent . OBJECTIVES To determine the effectiveness of vitamin D supplementation for improving bone mineral density in children , whether any effect varies by sex , age or pubertal stage , the type or dose of vitamin D given or baseline vitamin D status , and if effects persist after cessation of supplementation . SEARCH STRATEGY We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL Issue 3 , 2009 ) , MEDLINE ( 1966 to present ) , EMBASE ( 1980 to present ) , CINAHL ( 1982 to present ) , AMED ( 1985 to present ) and ISI Web of Science ( 1945 to present ) on 9 August 2009 , and we h and search ed key journal conference abstract s. SELECTION CRITERIA Placebo-controlled RCTs of vitamin D supplementation for at least three months in healthy children and adolescents ( aged from one month to . DATA COLLECTION AND ANALYSIS Two authors screened references for inclusion , assessed risk of bias , and extracted data . We conducted meta-analyses and calculated st and ardised mean differences ( SMD ) of the percent change from baseline in outcomes in treatment and control groups . We performed subgroup analyses by sex , pubertal stage , dose of vitamin D and baseline serum vitamin D and considered these as well as compliance and allocation concealment as possible sources of heterogeneity . MAIN RESULTS We included six RCTs ( 343 participants receiving placebo and 541 receiving vitamin D ) for meta-analyses . Vitamin D supplementation had no statistically significant effects on total body bone mineral content ( BMC ) , hip bone mineral density ( BMD ) or forearm BMD . There was a trend to a small effect on lumbar spine BMD ( SMD 0.15 , 95 % CI -0.01 to 0.31 , P = 0.07 ) . There were no differences in effects between high and low serum vitamin D studies at any site though there was a trend towards a larger effect with low vitamin D for total body BMC ( P = 0.09 for difference ) . In low serum vitamin D studies , significant effects on total body BMC and lumbar spine BMD were approximately equivalent to a 2.6 % and 1.7 % percentage point greater change from baseline in the supplemented group . AUTHORS ' CONCLUSIONS These results do not support vitamin D supplementation to improve bone density in healthy children with normal vitamin D levels , but suggest that supplementation of deficient children may be clinical ly useful . Further RCTs in deficient children are needed to confirm this
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"The hypothesis that breastfed infants in Beijing , China , have low vitamin D status and that sunshine exposure increases serum 25-hydroxyvitamin D ( 25-OHD ) concentrations was tested in a r and omized prospect i ve study involving 42 healthy infants 1 - 8 months of age . 24 controls were exposed to the usual amount of sunshine , while the 18 cases were provided with 2 hours of sunshine/day . All infants were being breastfed without vitamin D supplementation . Serum 25-OHD concentrations at entry into the study ranged from 3 - 61 ng/ml and increased with age . 3 infants in each group were diagnosed as having rickets . Serum 25-OHD concentrations did not change significantly during the 2-month study period among controls , while serum 25-OHD values increased significantly in the experimental group . Final infant serum 25-OHD concentrations correlated with ultraviolet exposure scores ( p.001 ) . The estimate of ultraviolet score needed to maintain a serum 25-OHD of 11 ng/ml was 2.4 ( 24 minutes/day with only the face uncovered ) . Rickets has been reported in as many as 18 % of Chinese infants and seems to especially affect those 2 - 4 months of age . The fact that not all infants with rickets in this study had low 25-OHD concentrations suggests 2 possibilities : 1 ) not all rickets is necessarily related to a vitamin D deficiency , or 2 ) serum 25-OHD concentrations are not the best indicator of vitamin D status . The low serum 25-OHD concentrations in many Chinese infants may be related to low maternal milk vitamin D content result ing from the lack of vitamin D food fortification . Overall , these results suggest that the diet of breastfed Chinese infants should be supplemented with orally administered vitamin",
"BACKGROUND Little is known about the effect of vitamin D status on bone gain in adolescents . OBJECTIVE The objective was to examine whether vitamin D status is associated with accrual of bone mineral density ( BMD ) and bone mineral apparent density ( BMAD ) . DESIGN This 3-y prospect i ve study examined the association between changes in BMD or BMAD and serum 25-hydroxyvitamin D [ 25(OH)D ] in 171 healthy Finnish girls aged 9 - 15 y. Lumbar spine and femoral neck BMDs were measured by dual-energy X-ray absorptiometry . RESULTS Baseline 25(OH)D correlated significantly with the unadjusted 3-y change in BMD at the lumbar spine ( r = 0.35 , P femoral neck ( r = 0.32 , P 3-y BMD accumulation between those with severe hypovitaminosis D [ 25(OH)D or = 37.5 nmol/L ] was 4 % ( 12.7 % , 13.1 % , and 16.7 % for the lowest , middle , and highest tertiles of 25(OH)D , respectively ; P for trend = 0.01 ) at the lumbar spine in the girls with advanced sexual maturation at baseline ( n = 129 ) . Moreover , the adjusted change in lumbar spine BMD was 27 % greater in the highest vitamin D intake tertile than in the lowest tertile in the same girls ( P for trend = 0.016 ) . CONCLUSIONS Pubertal girls with hypovitaminosis D seem to be at risk of not reaching maximum peak bone mass , particularly at the lumbar spine . Dietary enrichment or supplementation with vitamin D should be considered to ensure an adequate vitamin D status",
"A 14-y follow-up of 581 children who took part in a r and omized controlled trial of the effect of a milk supplement on growth of children was conducted to investigate the supplement 's effect on adult bone mineral content ( BMC ) and density ( BMD ) . BMC and BMD of the nondominant forearm were measured by single-photon absorptiometry in 371 subjects ( 64 % ) aged 20 - 23 y , at a proximal site ( shaft of radius and ulna ) and at a distal site near the wrist . BMC s and BMDs tended to be higher in the intervention group ( NS ) . Cross-sectionally , BMD was positively associated with body weight ( P less than 0.01 ) in both sexes ; inversely associated with alcohol consumption ( P less than 0.05 ) , and positively with manual occupation ( NS ) in men ; positively associated with current intakes of calcium ( P less than 0.05 ) , vitamin D ( P less than 0.01 ) , and sports activity during adolescence ( P less than 0.01 ) , and inversely with parity ( NS ) in women . In multiple linear-regression analysis body weight and sports activity during adolescence were stronger determinants of female BMD than was diet",
"New Zeal and children , particularly those of Māori and Pacific ethnicity , may be at risk for low vitamin D status because of low vitamin D intakes , the country 's latitude ( 35 - 46 degrees S ) , and skin color . The aim of this study was to determine 25-hydroxyvitamin D concentrations and their determinants in a national sample of New Zeal and children aged 5 - 14 y. The 2002 National Children 's Nutrition Survey was design ed to survey New Zeal and children , including oversampling of Māori and Pacific children to allow ethnic-specific analyses . A 2-stage recruitment process occurred using a r and om selection of schools , and children within each school . Serum 25-hydroxyvitamin D concentration [ mean ( 99 % CI ) nmol/L ] in Māori children ( n = 456 ) was 43 ( 38,49 ) , in Pacific ( n = 646 ) 36 ( 31,42 ) , and in New Zeal and European and Others ( NZEO ) ( n = 483 ) 53 ( 47,59 ) . Among Māori , Pacific , and NZEO , the prevalence ( % , 99 % CI ) of serum 25-hydroxyvitamin D deficiency ( insufficiency ( 25-hydroxyvitamin D concentrations were lower in winter than summer [ adjusted mean difference ( 99 % CI ) nmol/L ; 15 ( 8,22 ) ] , lower in girls than boys [ 5 ( 1,10 ) ] , and lower in obese children than in those of \" normal \" weight [ 6 ( 1,11 ) ] . Relative to NZEO , 25-hydroxyvitamin D concentrations were lower in Māori [ 9 ( 3,15 ) ] and Pacific children [ 16 ( 10,22 ) ] . Ethnicity and season are major determinants of serum 25-hydroxyvitamin D. There is a high prevalence of vitamin D insufficiency in New Zeal and children , which may or may not contribute to increased risk of osteoporosis and other chronic disease . There is a pressing need for more convincing evidence concerning the health risks associated with the low vitamin D status in New Zeal and children",
"BACKGROUND Little is known about the relative effectiveness of calcium supplementation from food or pills with or without vitamin D supplementation for bone mass accrual during the rapid growth period . OBJECTIVE The purpose was to examine the effects of both food-based and pill supplements of calcium and vitamin D on bone mass and body composition in girls aged 10 - 12 y. DESIGN This placebo-controlled intervention trial r and omly assigned 195 healthy girls at Tanner stage I-II , aged 10 - 12 y , with dietary calcium intakes 1 of 4 groups : calcium ( 1000 mg ) + vitamin D3 ( 200 IU ) , calcium ( 1000 mg ) , cheese ( 1000 mg calcium ) , and placebo . Primary outcomes were bone indexes of the hip , spine , and whole body by dual-energy X-ray absorptiometry and of the radius and tibia by peripheral quantitative computed tomography . RESULTS With the use of intention-to-treat or efficacy analysis , calcium supplementation with cheese result ed in a higher percentage change in cortical thickness of the tibia than did placebo , calcium , or calcium + vitamin D treatment ( P = 0.01 , 0.038 , and 0.004 , respectively ) and in higher whole-body bone mineral density than did placebo treatment ( P = 0.044 ) when compliance was > 50 % . With the use of a hierarchical linear model with r and om effects to control for growth velocity , these differences disappeared . CONCLUSIONS Increasing calcium intake by consuming cheese appears to be more beneficial for cortical bone mass accrual than the consumption of tablets containing a similar amount of calcium . Diverse patterns of growth velocity may mask the efficacy of supplementation in a short-term trial of children transiting through puberty",
"Background A two-year , community-based , group-r and omized trial to promote bone mass gains among 9–11 year-old girls through increased intake of calcium-rich foods and weight-bearing physical activity was evaluated . Methods Following baseline data collection , 30 5th- grade Girl Scout troops were r and omized to a two-year behavioral intervention program or to a no-treatment control group . Evaluations were conducted at baseline , one year , and two years . Measures included bone mineral content , density , and area ( measured by DXA ) , dietary calcium intake ( 24-hour recall ) , and weight-bearing physical activity ( physical activity checklist interview ) . Mixed-model regression was used to evaluate treatment-related changes in bone mineral content ( g ) for the total body , lumbar spine ( L1-L4 ) , proximal femur , one-third distal radius , and femoral neck . Changes in eating and physical activity behavioral outcomes were examined . Results Although the intervention was implemented with high fidelity , no significant intervention effects were observed for total bone mineral content or any specific bone sites . Significant intervention effects were observed for increases in dietary calcium . No significant intervention effects were observed for increases in weight-bearing physical activity . Conclusion Future research needs to identify the optimal dosage of weight-bearing physical activity and calcium-rich dietary behavior change required to maximize bone mass gains in pre-adolescent and adolescent girls",
"ABSTRACT . Fifty‐one healthy prepubertal schoolchildren were followed for 13 months in a double blind study . Twenty‐four of them were supplemented with 400 IU of vitamin D2 5–7 times weekly , while 27 received a placebo . The children were examined in winter both at the beginning and at the end of the study , and in the middle of the study in autumn . Mean 25‐hydroxyvitamin D levels in the supplemented group were significantly higher than those in the placebo group both in autumn and in winter , when the study ended . The vitamin D supplementation did not , however , affect other vitamin D metabolites , serum calcium , albumin , inorganic phosphorus , parathyroid hormone concentrations or alkaline phosphatase activity . Moreover , the supplementation caused no alterations in the weight or height gain or bone mineral content of the distal radius of the children , and thus sub clinical rickets could not be shown",
"The objective of this study was to determine whether vitamin D supplementation of breast-fed infants during the first year of life is associated with greater bone mineral content and /or areal bone mineral density ( aBMD ) in later childhood . The design was a retrospective cohort study . One hundred and six healthy prepubertal Caucasian girls ( median age , 8 yr ; range , 7 - 9 yr ) were classified as vitamin D supplemented or unsupplemented during the first year of life on the basis of a question naire sent to participating families and their pediatricians . Bone area ( square centimeters ) and bone mineral content ( grams ) were determined by dual energy x-ray absorptiometry at six skeletal sites . Vitamin D receptor ( VDR ) 3'-gene polymorphisms ( BsmI ) were also determined . The supplemented ( n = 91 ) and unsupplemented ( n = 15 ) groups were similar in terms of season of birth , growth in the first year of life , age , anthropometric parameters , and calcium intake at time of dual energy x-ray absorptiometry . The supplemented group had higher aBMD at the level of radial metaphysis ( mean + /- SEM , 0.301+/-0.003 vs. 0.283+/-0.008 ; P = 0.03 ) , femoral neck ( 0.638+/-0.007 vs. 0.584+/-0.021 ; P = 0.01 ) , and femoral trochanter ( 0.508+/-0.006 vs. 0.474+/-0.016 ; P = 0.04 ) . At the lumbar spine level aBMD values were similar ( 0.626+/-0.006 vs. 0.598+/-0.019 ; P = 0.1 ) . In a multiple regression model taking into account the effects of vitamin D supplementation , height , and VDR genotype on aBMD ( dependent variable ) , femoral neck aBMD remained higher by 0.045 g/cm2 in the supplemented group ( P = 0.02 ) . Vitamin D supplementation in infancy was found to be associated with increased aBMD at specific skeletal sites later in childhood in prepubertal Caucasian girls",
"Severe vitamin D deficiency is common among Muslim immigrants . The dose necessary to correct the deficiency and its consequence for bone health are not known for immigrants . The aim was to assess the effect of relatively low dosages of supplemental vitamin D on vitamin D and bone status in Pakistani immigrants . This 1-year-long r and omised double-blinded placebo-controlled intervention with vitamin D3 ( 10 and 20 microg/d ) included girls ( 10.1 - 14.7 years ) , women ( 18.1 - 52.7 years ) and men ( 17.9 - 63.5 years ) of Pakistani origin living in Denmark . The main endpoints were serum 25-hydroxyvitamin D ( S-25OHD ) , parathyroid hormone , bone turnover markers and bone mass . The study showed that supplementation with 10 and 20 microg vitamin D3 per d increased S-25OHD concentrations similarly in vitamin D-deficient Pakistani women ( 4-fold ) , and that 10 microg increased S-25OHD concentrations 2-fold and 20 microg 3-fold in Pakistani men . S-25OHD concentrations increased at 6 months and were stable thereafter . Baseline S-25OHD concentrations tended to be lower in girls and women than in men ; females achieved about 46 nmol/l and men 55 nmol/l after supplementation . Serum intact parathyroid hormone concentrations decreased at 6 months , but there was no significant effect of the intervention on bone turnover markers and dual-energy X-ray absorptiometry measurements of the whole body and lumbar spine",
"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 study was to estimate the hospital cost of vertebral fractures in the EU using national data sets to explore some of the method ologic limitations associated with such an approach . Hospital costs for vertebral fractures across the EU were compared with the hospital costs associated with hip fractures . Additionally , these costs were placed into the health care context by making comparisons with national health care expenditure . All EU Ministries of Health were contacted to identify national data sets to estimate the average length of stay , cost per diem and the number of patients discharged with vertebral fractures . Where national information was not available expert opinion and data from the relevant literature were used instead . Countries show a marked difference in the length of stay between men and women , with differences ranging from 0.32 days in Austria to 20.2 days in Spain . The average hospitalization rate was found to be 8 % across the EU , with higher rates found for men than for women . Interestingly a positive correlation between health expenditure per capita and hospitalization rates was found . The total cost of vertebral fractures in the EU was estimated at € 377 million per year . Across the EU the hospital cost of a vertebral fracture was on average 63 % that of a hip fracture . National data sets allow us to estimate the cost of vertebral fractures in the EU but show limitations . In the absence of largescale prospect i ve studies , national data sets need to be further refined to ensure more accurate estimations of the cost of vertebral fractures in the EU",
"Much existing data on the effects of calcium or milk products on bone mineral accretion are based on bone mineral content ( BMC ) or areal bone mineral density ( aBMD ) , neither of which accounts for changing bone size during the growing period . The aim of this study was to investigate the effects of 2-year milk supplementation on total body size-corrected BMD in Chinese girls with low habitual dietary calcium intake . Chinese girls aged 10 years were r and omised , according to their school , to receive calcium fortified milk ( Ca milk ) , or calcium and vitamin D fortified milk ( CaD milk ) for two years or act as unsupplemented controls . Dual-energy X-ray absorptiometry total body bone measures were obtained from 345 girls at baseline and 2 years . Size-corrected total body and regional BMD was calculated as : BMDsc = BMC /BApc , where pc was the regression coefficient of the natural logarithm transformed total body BMC and bone area . After 2 years , both supplemented groups had significantly greater gain in BMDsc of total body ( 3.5 - 5.8 % , p legs ( 3.0 - 5.9 % , p Milk supplementation showed positive effects on bone mineral accretion when accounting for the changing skeletal size during growth . The effects were mainly on the lower limbs",
"In theory , sunshine exposure is sufficient to maintain normal vitamin D concentrations for the optimal growth of newborn infants . To determine whether season of birth , latitude ( north v. south ) and increasing dosages of vitamin D supplements would influence the growth rate for the first 6 months of life , 255 healthy fall- and spring-born infants from two northern and two southern cities in China were r and omly assigned to receive either 100 , 200 , or 400 IU of vitamin D a day . The study showed that season of birth and dose of vitamin D did not affect the growth rate of infants born in the same latitude , but a significant difference was found in the gain in length over the 6-month period between infants from the north and infants from the south ( P = 0.0001 ) . Regional differences among the Chinese people , other than sunshine exposure , may have influenced the difference in length gain",
"A previous r and omized placebo-controlled double-blinded clinical trial revealed that treatment of osteoporotic subjects supplemented with 200 or 400IU/day vitamin D3 with 0.75 microg/day ED-71 for 12 months increased lumbar and hip bone mineral density ( BMD ) by 3.4 and 1.5 % , respectively , compared to placebo group ( JCE&M 90:5031,2005 ) . These effects on BMD were stronger than any previous results using 1alpha(OH)D3 or 1,25(OH)2D3 . However , there still was a concern that the effect of ED-71 could be observed because serum 25(OH)D in many of these subjects were below its optimal level . In order to address this issue , we performed post hoc analysis to compare the effect of ED-71 on lumbar and hip BMD between subjects with upper ( > 29 ng/mL ) and lower tertiles ( Lumbar BMD after 12-month treatment with 0.5 , 0.75 and 1.0 microg/day ED-71 increased similarly in both lower and upper tertile groups of serum 25(OH)D. In addition , hip BMD also showed a tendency to increase when 0.75 and 1.0 microg/day ED-71 groups were combined together in both upper and lower serum 25(OH)D tertile groups , although the increase was not statistically significant . These results demonstrate that the effect of ED-71 on bone is independent of supplementary effect for nutritional vitamin D insufficiency , and suggest that ED-71 may exert its effect as a unique VDR lig and with stronger effect on bone compared to the natural lig and , 1,25(OH)2D3",
"UNLABELLED The effect of vitamin D supplementation on bone mineral augmentation in 212 adolescent girls with adequate calcium intake was studied in a r and omized placebo-controlled setting . Bone mineral augmentation determined by DXA increased with supplementation both in the femur and the lumbar vertebrae in a dose-responsive manner . Supplementation decreased the urinary excretion of resorption markers , but had no impact on formation markers . INTRODUCTION Adequate vitamin D intake protects the elderly against osteoporosis , but there exists no indisputable evidence that vitamin D supplementation would benefit bone mineral augmentation . The aim of this 1-year study was to determine in a r and omized double-blinded trial the effect of 5 and 10 microg vitamin D3 supplementation on bone mineral augmentation in adolescent girls with adequate dietary calcium intake . MATERIAL S AND METHODS Altogether , 228 girls ( mean age , 11.4 + /- 0.4 years ) participated . Their BMC was measured by DXA from the femur and lumbar spine . Serum 25-hydroxyvitamin D [ S-25(OH)D ] , intact PTH ( S-iPTH ) , osteocalcin ( S-OC ) , and urinary pyridinoline ( U-Pyr ) and deoxypyridinoline ( U-Dpyr ) were measured . Statistical analysis was performed both with the intention-to-treat ( IT ) and compliance-based ( CB ) method . RESULTS In the CB analysis , vitamin D supplementation increased femoral BMC augmentation by 14.3 % with 5 microg and by 17.2 % with 10 microg compared with the placebo group ( ANCOVA , p = 0.012 ) . A dose-response effect was observed in the vertebrae ( ANCOVA , p = 0.039 ) , although only with the highest dose . The mean concentration of S-25(OH)D increased ( p S-iPTH or S-OC , but it decreased U-DPyr ( p = 0.042 ) . CONCLUSIONS Bone mineral augmentation in the femur was 14.3 % and 17.2 % higher in the groups receiving 5 and 10 microg of vitamin D , respectively , compared with the placebo group , but only 10 mug increased lumbar spine BMC augmentation significantly . Vitamin D supplementation decreased the concentration of bone resorption markers , but had no impact on bone formation markers , thus explaining increased bone mineral augmentation . However , the positive effects were noted with the CB method but not with IT",
"A 2-year milk intervention trial was carried out with 757 girls , aged 10 years , from nine primary schools in Beijing ( April 1999 - March 2001 ) . Schools were r and omised into three groups : group 1 , 238 girls consumed a carton of 330 ml milk fortified with Ca on school days over the study period ; group 2 , 260 girls received the same quantity of milk additionally fortified with 5 or 8 microg cholecalciferol ; group 3 , 259 control girls . Anthropometric and bone mineralisation measurements , as well as dietary , health and physical-activity data , were collected at baseline and after 12 and 24 months of the trial . Over the 2-year period the consumption of this milk , with or without added cholecalciferol , led to significant increases in the changes in height ( > or = 0.6 % ) , sitting height ( > or = 0.8 % ) , body weight ( > or 2.9 % ) , and ( size-adjusted ) total-body bone mineral content ( > or = 1.2 % ) and bone mineral density ( > or = 3.2 % ) . Those subjects receiving additional cholecalciferol compared with those receiving the milk without added 25-hydoxycholecalciferol had significantly greater increases in the change in ( size-adjusted ) total-body bone mineral content ( 2.4 v. 1.2 % ) and bone mineral density ( 5.5 v. 3.2 % ) . The milk fortified with cholecalciferol significantly improved vitamin D status at the end of the trial compared with the milk alone or control groups . It is concluded that an increase in milk consumption , e.g. by means of school milk programmes , would improve bone growth during adolescence , particularly when Ca intake and vitamin D status are low",
"BACKGROUND Despite the high prevalence of hypovitaminosis D in children and adolescents worldwide , the impact of vitamin D deficiency on skeletal health is unclear . METHODS One hundred seventy-nine girls , ages 10 - 17 yr , were r and omly assigned to receive weekly oral vitamin D doses of 1,400 IU ( equivalent to 200 IU/d ) or 14,000 IU ( equivalent to 2,000 IU/d ) in a double-blind , placebo-controlled , 1-yr protocol . Areal bone mineral density ( BMD ) and bone mineral content ( BMC ) at the lumbar spine , hip , forearm , total body , and body composition were measured at baseline and 1 yr . Serum calcium , phosphorus , alkaline phosphatase , and vitamin D metabolites were measured during the study . RESULTS In the overall group of girls , lean mass increased significantly in both treatment groups ( P bone area and total hip BMC increased in the high-dose group ( P lean mass increased significantly in both treatment groups , and there were consistent trends for increments in BMD and /or BMC at several skeletal sites , reaching significance at lumbar spine BMD in the low-dose group and at the trochanter BMC in both treatment groups . There was no significant change in lean mass , BMD , or BMC in postmenarcheal girls . CONCLUSIONS Vitamin D replacement had a positive impact on musculoskeletal parameters in girls , especially during the premenarcheal period",
"Women with low bone density in the radius or calcaneus are at increased risk of hip fracture . To see whether bone density of the hip measured by dual X-ray absorptiometry is a better predictor of hip fracture than measurements of other bones , we assessed bone density at several sites in 8134 women aged 65 years or more . 65 women had hip fractures during a mean follow-up of 1.8 years . Each SD decrease in femoral neck bone density increased the age-adjusted risk of hip fracture 2.6 times ( 95 % CL 1.9 , 3.6 ) . Women with bone density in the lowest quartile had an 8.5-fold greater risk of hip fracture than those in the highest quartile . Bone density of the femoral neck was a better predictor than measurements of the spine ( p radius ( p Low hip bone density is a stronger predictor of hip fracture than bone density at other sites . Efforts to prevent hip fractures should focus on women with low hip bone density",
"UNLABELLED Recent studies have shown a high prevalence of calcium and vitamin D deficiencies in adolescents . The aim of this present study was to follow the changes in calcium status and 25 hydroxyvitamin D ( 25[OH]D ) and parathyroid hormone ( iPTH ) levels during winter in preadolescents and adolescents from four university hospitals in northern France . SUBJECTS AND METHODS Two groups of teenagers and adolescents ( range : 10 - 15 years ) were followed from October 1996 to June 1997 . They were given either 100,000 IU of vitamin D ( treated group n = 33 ) or a placebo ( control group n = 35 ) in October , January and April . Serum calcium , phosphate , 25(OH)D and iPTH levels were measured at inclusion and every three months thereafter . RESULTS At inclusion , plasma or serum 25(OH)D levels were 25(OH)D occurred during the study , while plasma or serum iPTH levels increased to 34 + /- 11 pg/mL. In the treated groups , 25(OH)D levels remained > 20 ng/mL in every subject ; no hypercalcemia was observed ; and the mean plasma or serum iPTH level was 25 + /- 14 pg/mL at the end of the study . CONCLUSION Teenagers presented with a high prevalence of biological vitamin D deficiency at the end of summer . The increase of iPTH during winter in the unsupplemented group suggests that this has secondary consequences on their calcium homeostasis unless they are supplemented with vitamin D. We advocate a sufficient calcium supply and a 100,000 IU vitamin D supplement given two or three times during winter to preadolescents and adolescents living in northern France"
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QUESTION Does motor imagery training improve measures of balance , mobility and falls in older adults without a neurological condition ? DESIGN Systematic review and meta- analysis of r and omised controlled trials . PARTICIPANTS Adults aged at least 60 years and without a neurological condition . INTERVENTION Three or more sessions of motor imagery training . OUTCOME MEASURES The primary outcomes were balance measures ( such as single leg stance and Berg Balance scale ) and mobility measures ( such as gait speed and the Timed Up and Go test ) . Falls were a secondary outcome measure . Risk of bias was evaluated using the PEDro Scale , and overall quality of evidence was assessed using the Grade s of Research , Assessment , Development and Evaluation ( GRADE ) approach . RESULTS Twelve trials including 356 participants were included in the systematic review and 10 trials ( 316 participants ) were included in the meta-analyses . All trials included either apparently healthy participants or older adults after orthopaedic surgery . There was evidence that motor imagery training can significantly improve balance ( SMD 1.03 , 95 % CI 0.25 to 1.82 ) , gait speed ( MD 0.13 m/s , 95 % CI 0.04 to 0.22 ) and Timed Up and Go ( MD 1.64 seconds , 95 % CI 0.79 to 2.49 ) in older adults ; however , the quality of evidence was very low to low . No data regarding falls were identified . CONCLUSION Motor imagery training improves balance and mobility in older adults who do not have a neurological condition . These results suggest that motor imagery training could be an adjunct to st and ard physiotherapy care in older adults , although it is unclear whether or not the effects are clinical ly worthwhile . TRIAL REGISTRATION PROSPERO CRD42017069954
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[
"This study was design ed to evaluate the effects of whole body vibration ( WBV ) exercise , mental training ( MT ) , and the concurrent effect of WBV and MT on lower body balance , neuromuscular performance , and leg muscle strength in elderly men . In a r and omized control trial study with parallel group design , 42 older men ( mean±st and ard deviation age , 68±5.78 years ) were r and omly divided into four groups : WBV ( n=11 ) , MT ( n=12 ) , WBV+MT ( n=10 ) , and control ( n=9 ) groups . The protocol of training consisted of three sessions per week for 8 weeks and about 30 min for each session . The WBV exercise was performed on a vibration machine . In MT group , participants were asked to mentally visualize to do the Timed Up and Go and relaxation technics . postural stability , the Timed Up and Go test , 5-repetition chair-rising test , 6-m t and em gait test , 10-m walking , and leg isometric strength were measured in baseline and after 8-week intervention . Repeated measures - analysis of variance followed by post hoc was used to analyses the data . The results of this study showed that there were significant improvements ( P in postural stability , Timed Up and Go , 5-repetition chair-rising , 6-m t and em gait test , 10-m walking , and leg isometric strength in WBV , MT , and WBV+MT in comparison with baseline and in comparison with control group . It seems that older adults can take benefit from WBV and MT and WBV+MT exercise as a cost-effective and practical way without side effects to improve postural control , mobility , and functional performance",
"& NA ; Physical therapists seeking to use evidence to guide their practice may have limited time to read research reports . One way to reduce the time required to identify and read about the research that is relevant to a particular clinical question is to read a systematic review that summarizes multiple studies . This paper explains the process that is used to conduct systematic review s , which includes the establishment of a protocol , comprehensive search ing , appraisal of the quality of the included studies , data extraction and meta analysis , and consideration of the clinical and research implication s of the findings . We also consider how the reader of a systematic review can determine whether the review is likely to provide an unbiased ( believable ) estimate of the treatment effect . A systematic review of r and omized trials of a cardiopulmonary physical therapy intervention is used as an example . The issue of appraisal of quality is then discussed further , with a demonstration of how one vali date d tool for quality appraisal ‐‐the PEDro scale‐‐can be used to evaluate a r and omized trial in cardiopulmonary physical therapy",
"For consciously performed motor tasks executed in a defined and constant way , both motor imagery ( MI ) and action observation ( AO ) have been shown to promote motor learning . It is not known whether these forms of non-physical training also improve motor actions when these actions have to be variably applied in an unstable and unpredictable environment . The present study therefore investigated the influence of MI balance training ( MI_BT ) and a balance training combining AO and MI ( AO+MI_BT ) on postural control of undisturbed and disturbed upright stance on unstable ground . As spinal reflex excitability after classical ( i.e. , physical ) balance training ( BT ) is generally decreased , we tested whether non-physical BT also has an impact on spinal reflex circuits . Thirty-six participants were r and omly allocated into an MI_BT group , in which participants imagined postural exercises , an AO+MI_BT group , in which participants observed videos of other people performing balance exercises and imagined being the person in the video , and a non-active control group ( CON ) . Before and after 4 weeks of non-physical training , balance performance was assessed on a free-moving platform during stance without perturbation and during perturbed stance . Soleus H-reflexes were recorded during stable and unstable stance . The post-measurement revealed significantly decreased postural sway during undisturbed and disturbed stance after both MI_BT and AO+MI_BT . Spinal reflex excitability remained unchanged . This is the first study showing that non-physical training ( MI_BT and AO+MI_BT ) not only promotes motor learning of “ rigid ” postural tasks but also improves performance of highly variable and unpredictable balance actions . These findings may be relevant to improve postural control and thus reduce the risk of falls in temporarily immobilized patients",
"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",
"Abstract Purpose : The aim of this study was to measure physical and functional outcomes during the acute postoperative recovery in patients who underwent total knee arthroplasty . Motor imagery has been shown to decrease pain and promote functional recovery after both neurological and peripheral injuries . Yet , whether motor imagery can be included as an adjunct effective method into physical therapy programs following total knee arthroplasty remains a working hypothesis that we aim to test in a pilot study . Method : Twenty volunteers were r and omly assigned to either a motor imagery or a control group . Pain , range of motion , knee girth as well as quadriceps strength and Timed Up and Go Test time were the dependent variables during pre-test and post-test . Results : The motor imagery group exhibited larger decrease of ipsilateral pain and knee girth , a slightly different evolution of range of motion and an increase of ipsilateral quadriceps strength compared to the control group . No effects of motor imagery on Timed Up and Go Test scores were observed . Conclusion : Implementing motor imagery practice into the course of physical therapy enhanced various physical outcomes during acute postoperative recovery after total knee arthroplasty . According to this pilot study , motor imagery might be relevant to promote motor relearning and recovery after total knee arthroplasty . Partial effect-sizes should be conducted in the future . Implication s for rehabilitation Adding motor imagery to physical therapy sessions during the acute period following total knee arthroplasty : • Enhances quadriceps strength . • Alleviates pain . • Enhances range of motion . • Does not have any effect on basic functional mobility . • Does not have any effect on knee girth",
"Background and purpose . Mental practice ( MP ) , which involves cognitive rehearsal of physical movements , is a noninvasive , inexpensive method of enabling repetitive , task-specific practice ( RTP ) . Recent , r and omized controlled data suggest that MP , when combined with an RTP therapy program , increases affected arm use and function significantly more than RTP only . As a next step , this 10-subject case series examined the possibility that cortical plasticity is a mechanism underlying the treatment effect of MP when combined with RTP . Method . Ten chronic stroke patients ( mean = 36.7 months ) exhibiting stable , moderate motor deficits received 30-minute therapy sessions for their affected arms , occurring 3 days/week for 10 weeks , and emphasizing valued activities of daily living ( ADLs ) . Directly after therapy , subjects received 30-minute MP sessions , which required MP of the ADLs performed during therapy . Behavioral outcomes were blindly evaluated using the Action Research Arm Test ( ARAT ) and the Fugl-Meyer Assessment ( FM ) . Functional magnetic resonance imaging ( fMRI ) was administered before and after intervention to assess cortical changes . Results . Before intervention , subjects exhibited stable motor deficits . After intervention , subjects exhibited ARAT and FM score increases ( + 5.3 and + 4.2 , respectively ) and clinical ly significant gains in ADLs . Postintervention fMRI revealed significant increases in activation to wrist flexion and extension of the affected h and in the premotor area and primary motor cortex ipsilateral and contralateral to the affected h and , as well as in superior parietal cortex ipsilateral to the affected h and . Decreased activation was noted in parietal cortex of the hemisphere ipsilateral to the affected h and . These changes correlated with anatomical regions in which behavioral changes were observed in the ARAT and FM . Conclusions . MP is an easy to use , cost-effective strategy that was again shown to improve affected arm outcomes after stroke . This is the first study to demonstrate alteration in the cortical map in response to MP training ",
"Purpose To investigate the influence of a single session of locomotor-based motor imagery training on motor learning and physical performance . Patients and methods Thirty independent adults aged > 65 years took part in the r and omized controlled trial . The study was conducted within an exercise science laboratory . Participants were r and omly divided into three groups following baseline locomotor testing : motor imagery training , physical training , and control groups . The motor imagery training group completed 20 imagined repetitions of a locomotor task , the physical training group completed 20 physical repetitions of a locomotor task , and the control group spent 25 minutes playing mentally stimulating games on an iPad . Imagined and physical performance times were measured for each training repetition . Gait speed ( preferred and fast ) , timed-up- and -go , gait variability and the time to complete an obstacle course were completed before and after the single training session . Results Motor learning occurred in both the motor imagery training and physical training groups . Motor imagery training led to refinements in motor planning result ing in imagined movements better matching the physically performed movement at the end of training . Motor imagery and physical training also promoted improvements in some locomotion outcomes as demonstrated by medium to large effect size improvements after training for fast gait speed and timed-up- and -go . There were no training effects on gait variability . Conclusion A single session of motor imagery training promoted motor learning of locomotion in independent older adults . Motor imagery training of a specific locomotor task also had a positive transfer effect on related physical locomotor performance outcomes",
"This study aim ed at determining whether the combination of action observation and motor imagery ( AO + MI ) of locomotor tasks could positively affect rehabilitation outcome after hip replacement surgery . Of initially 405 screened participants , 21 were r and omly split into intervention group ( N = 10 ; mean age = 64 y ; AO + MI of locomotor tasks : 30 min/day in the hospital , then 3 × /week in their homes for two months ) and control group ( N = 11 , mean age = 63 y , active controls ) . The functional outcomes ( Timed Up and Go , TUG ; Four Step Square Test , FSST ; and single- and dual-task gait and postural control ) were measured before ( PRE ) and 2 months after surgery ( POST ) . Significant interactions indicated better rehabilitation outcome for the intervention group as compared to the control group : at POST , the intervention group revealed faster TUG ( p = 0.042 ) , FSST ( p = 0.004 ) , and dual-task fast-paced gait speed ( p = 0.022 ) , reduced swing-time variability ( p = 0.005 ) , and enhanced cognitive performance during dual tasks while walking or balancing ( p observed for body sway parameters ( p ≥ 0.229 ) . These results demonstrate that AO + MI is efficient to improve motor-cognitive performance after hip surgery . Moreover , only parameters associated with locomotor activities improved whereas balance skills that were not part of the AO + MI intervention were not affected , demonstrating the specificity of training intervention . Overall , utilizing AO + MI during rehabilitation is advised , especially when physical practice is limited",
"OBJECTIVES To determine the effect of guided imagery ( GI ) on functional outcomes of total knee replacement ( TKR ) , explore psychological and neuroimmune mediators , and assess feasibility of study implementation . DESIGN Investigator-blinded , r and omized , placebo-controlled pilot study . SETTING S Hospital , surgeon 's office , participant 's home . PARTICIPANTS 82 persons undergoing TKR . INTERVENTIONS Audiorecordings of TKR-specific GI scripts or placebo-control audiorecordings of audiobook segments . OUTCOME MEASURES Gait velocity and Western Ontario and McMaster Universities Arthritis Index ( WOMAC ) Function scale . RESULTS Outcomes for 58 participants ( 29 receiving GI and 29 controls ) were analyzed at 6 months after surgery . The most frequent reason for noncompletion was protocol -driven exclusion at 6 months for having the contralateral knee replaced before the study endpoint ( n = 15 ) . With imaging ability as a moderator , gait velocity , but not WOMAC Function score , was significantly improved at 6 months in the GI group . Participants in the GI group , but not the control group , had lower WOMAC Pain scores at 3 weeks after surgery than at baseline . Hair cortisol concentration was significantly lower at 6 months after surgery than at baseline in the GI group but not the control group . GI group participants had lower treatment adherence but greater treatment credibility than the control group . CONCLUSION R and omized controlled trials of GI in the TKR population are feasible , but inclusion /exclusion criteria influence attrition . Further studies are needed to elaborate this study 's findings , which suggest that guided imagery improves objective , but not patient-reported , outcomes of TKR . Hair cortisol concentration results suggest that engagement in a time-limited guided imagery intervention may contribute to stress reduction even after the intervention is terminated . Further investigation into optimal content and dosing of GI is needed",
"QUESTION What is the effect of a multifactorial intervention on frailty and mobility in frail older people who comply with their allocated treatment ? DESIGN Secondary analysis of a r and omised , controlled trial to derive an estimate of complier average causal effect ( CACE ) of treatment . PARTICIPANTS A total of 241 frail community-dwelling people aged ≥ 70 years . INTERVENTION Intervention participants received a 12-month multidisciplinary intervention targeting frailty , with home exercise as an important component . Control participants received usual care . OUTCOME MEASURES Primary outcomes were frailty , assessed using the Cardiovascular Health Study criteria ( range 0 to 5 criteria ) , and mobility measured using the 12-point Short Physical Performance Battery . Outcomes were assessed 12 months after r and omisation . The treating physiotherapist evaluated the amount of treatment received on a 5-point scale . RESULTS 216 participants ( 90 % ) completed the study . The median amount of treatment received was 25 to 50 % ( range 0 to 100 ) . The CACE ( ie , the effect of treatment in participants compliant with allocation ) was to reduce frailty by 1.0 frailty criterion ( 95 % CI 0.4 to 1.5 ) and increase mobility by 3.2 points ( 95 % CI 1.8 to 4.6 ) at 12 months . The mean CACE was substantially larger than the intention-to-treat effect , which was to reduce frailty by 0.4 frailty criteria ( 95 % CI 0.1 to 0.7 ) and increase mobility by 1.4 points ( 95 % CI 0.8 to 2.1 ) at 12 months . CONCLUSION Overall , compliance was low in this group of frail people . The effect of the treatment on participants who comply with allocated treatment was substantially greater than the effect of allocation on all trial participants . TRIAL REGISTRATION Australian and New Zeal and Trial Registry ANZCTRN12608000250336 . [ Fairhall N , Sherrington C , Cameron ID , Kurrle SE , Lord SR , Lockwood K , Herbert RD ( 2016 ) A multifactorial intervention for frail older people is more than twice as effective among those who are compliant : complier average causal effect analysis of a r and omised trial . Journal of Physiotherapy63 : 40 - 44 ]",
"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 .",
"OBJECTIVES To examine the effects of guided relaxation and imagery ( GRI ) on improvement in falls self-efficacy in older adults who report having a fear of falling . DESIGN R and omized , controlled trial with allocation to GRI or guided relaxation with music of choice . SETTING General community . PARTICIPANTS Ninety-one men and women aged 60 to 92 . INTERVENTION Participants were r and omized to listen to a GRI audio compact disk ( intervention group ) or a guided relaxation audio compact disk and music of choice ( control group ) twice a week for 6 weeks for 10 minutes per session . MEASUREMENTS Primary outcome measure was the Short Falls Efficacy Scale-International ( FES-I ) . Secondary outcome measures were the Leisure Time Exercise Question naire ( LTEQ ) and the Timed Up and Go ( TUG ) mobility test . RESULTS GRI participants reported greater improvements on the Short FES-I ( P = .002 ) and LTEQ ( P = .001 ) scores and shorter time on the TUG ( P = .002 ) than the guided relaxation and music-of-choice group . CONCLUSION GRI was more effective at increasing falls self-efficacy and self-reported leisure time exercise and reducing times on a simple mobility test than was guided relaxation with music of choice . GRI is an effective , simple , low-cost tool for older adults to improve falls self-efficacy and leisure time exercise behaviors",
"OBJECTIVES To evaluate the effect of an exercise-based model of hospital and in-home follow-up care for older people at risk of hospital readmission on emergency health service utilization and quality of life . DESIGN R and omized controlled trial . SETTING Tertiary metropolitan hospital in Australia . PARTICIPANTS One hundred twenty-eight patients ( 64 intervention , 64 control ) with an acute medical admission , aged 65 and older and with at least one risk factor for readmission ( multiple comorbidities , impaired functionality , aged > or=75 , recent multiple admissions , poor social support , history of depression ) . INTERVENTION Comprehensive nursing and physiotherapy assessment and individualized program of exercise strategies and nurse-conducted home visit and telephone follow-up commencing in the hospital and continuing for 24 weeks after discharge . MEASUREMENTS Emergency health service utilization ( emergency hospital readmissions and visits to emergency department , general practitioner ( GP ) , or allied health professional ) and health-related quality of life ( Medical Outcomes Study 12-item Short Form Survey ( SF-12v2 ) collected at baseline and 4 , 12 , and 24 weeks after discharge . RESULTS The intervention group required significantly fewer emergency hospital readmissions ( 22 % of intervention group , 47 % of control group , P=.007 ) and emergency GP visits ( 25 % of intervention group , 67 % of control group , P improvements in quality of life than the control group as measured using SF-12v2 Physical Component Summary scores ( F ( 3 , 279)=30.43 , P Mental Component Summary scores ( F ( 3 , 279)=7.20 , P individualized exercise program and long-term telephone follow-up may reduce emergency health service utilization and improve quality of life of older adults at risk of hospital readmission",
"Objective : Falls , loss of health-related quality of life and physical capacity , reduced participation in activities of daily living , and increased fear of falling are all potential outcomes for older adults discharged from hospital . A low-cost video based exercise programme may address this . Design : This study was a r and omized controlled trial with blinded outcomes assessment and a six-month follow-up . Subjects and setting : Participants were older adults ( > 65 years ) using a mobility aid discharged from a tertiary hospital in Brisbane , Australia , without referral for community-based rehabilitation services . Intervention : A digital video disk-based programme encompassing six exercise types each with six levels of difficulty . A home visit from a project physiotherapist was conducted to ensure patient safety . Control group patients received usual care . Main measures : Falls , health-related quality of life , participation in activities of daily living , physical capacity and fear of falling . Results : Study participants ( n = 53 , 19 intervention , 34 control ) experienced decreasing health-related quality of life , several falls ( 72 ) , and lower levels of participation in activities of daily living over the six-month follow-up . The intervention group did not differ significantly from the control group in terms of the outcomes examined , though a non-significant reduction in the rate of falls was observed . Intervention group participants complied with the exercise programme well during the first two weeks following discharge from hospital but then reduced their compliance levels thereafter . Conclusions : The intervention may be beneficial for reducing the rate of falls in this patient population though further research with a larger sample size is indicated",
"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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Rituximab is the first antibody-based therapy approved in cancer . The role of this treatment for non-Hodgkin 's lymphoma has evolved significantly since its introduction . We aim ed to systematic ally review the literature on rituximab in non-Hodgkin 's lymphoma and provide consensus guidelines as to the rational use of this agent . Vali date d methodology from the Cancer Care Ontario Program in Evidence -Based Care was applied . A comprehensive literature search was completed by review ers from the Hematology Disease Site Group of Cancer Care Ontario . Data were abstract ed from r and omized controlled trials of rituximab-containing regimens for patients with non-Hodgkin 's lymphoma . Twenty-three r and omized controlled trials ( RCTs ) of rituximab-based therapy were analyzed . Consistent and clinical ly important benefits in progression-free and overall survival and were seen in the following setting s : ( 1 ) addition of rituximab to combination chemotherapy for initial treatment of diffuse large B-cell lymphoma and other aggressive B-cell lymphomas ; ( 2 ) addition of rituximab to combination chemotherapy for initial and subsequent treatment of follicular lymphoma and other indolent B-cell lymphomas ; and ( 3 ) use of rituximab alone as extended maintenance therapy in patients with indolent B-cell lymphomas who have responded to initial treatment . The consensus opinion of the Hematology Disease Site Group is that rituximab is recommended for these indications
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[
"BACKGROUND The role of rituximab in combination with different CHOP ( cyclophosphamide , doxorubicin , vincristine , and prednisone)-like chemotherapy regimens in young patients with good-prognosis diffuse large-B-cell lymphoma remains to be defined . We aim ed to compare CHOP-like chemotherapy and rituximab with CHOP-like chemotherapy alone in these patients . METHODS 824 patients who were from 18 countries ; aged 18 - 60 years ; and who had no risk factors or one risk factor according to age-adjusted International Prognostic Index ( IPI ) , stage II-IV disease , or stage I disease with bulk were enrolled . These patients were r and omly assigned to six cycles of CHOP-like chemotherapy and rituximab ( n=413 ) or to six cycles of CHOP-like chemotherapy alone ( n=411 ) . Bulky and extranodal sites received additional radiotherapy . The primary endpoint was event-free survival ; secondary endpoints were response , progression under therapy , progression-free survival , overall survival , and frequency of toxic effects . Analyses were done by intention to treat and per protocol . This trial is registered at http://www . clinical trials.gov , NCT 00064116 . FINDINGS After a median follow-up of 34 months ( range 0.03 - 61 ) , patients assigned chemotherapy and rituximab had increased 3-year event-free survival compared with those assigned chemotherapy alone ( 79 % [ 95 % CI 75 - 83 ] vs 59 % [ 54 - 64 ] ; difference between groups 20 % [ 13 - 27 ] , log-rank p 3-year overall survival ( 93 % [ 90 - 95 ] vs 84 % [ 80 - 88 ] ; difference between groups 9 % [ 3 - 13 ] , log-rank p=0.0001 ) . Event-free survival was affected by treatment group , presence of bulky disease , and age-adjusted IPI : after chemotherapy and rituximab , a favourable subgroup ( ie , IPI=0 , no bulk ) could be defined from a less-favourable subgroup ( ie , IPI=1 or bulk , or both ) . Groups did not differ in the frequency of adverse events . INTERPRETATION Rituximab added to six cycles of CHOP is an effective treatment for young patients with good-prognosis diffuse large-B-cell lymphoma . The definition of two prognostic subgroups allows for a more refined therapeutic approach for these patients",
"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 addition of rituximab to cyclophosphamide , doxorubicin , vincristine , and prednisone ( CHOP ) chemotherapy results in significant improvement in clinical outcome for individuals with non-HIV-associated aggressive B-cell lymphoma . To assess the potential risks and benefits of the addition of rituximab to CHOP for HIV-associated non-Hodgkin lymphoma ( HIV-NHL ) 150 patients receiving CHOP for HIV-NHL were r and omized ( 2:1 ) to receive 375 mg/m(2 ) rituximab with each chemotherapy cycle ( n = 99 ) or no immunotherapy ( n = 50 ) in a multicenter phase 3 trial . The complete response rate ( CR + CRu ) was 57.6 % for R-CHOP and 47 % for CHOP ( P = .147 ) . With a median follow-up of 137 weeks , time to progression , progression-free survival , and overall survival times were 125 , 45 , and 139 weeks , respectively , for R-CHOP and 85 , 38 , and 110 weeks , respectively , for CHOP ( P = not significant , all comparisons ) . Treatment-related infectious deaths occurred in 14 % of patients receiving R-CHOP compared with 2 % in the chemotherapy-alone group ( P = .035 ) . Of these deaths , 60 % occurred in patients with CD4 counts less than 50/mm(3 ) . Progression-free survival was significantly influenced by CD4(+ ) count ( P International Prognostic Index score ( P = .022 ) , but not bcl-2 status . The addition of rituximab to CHOP in patients with HIV-NHL may be associated with improved tumor responses . However , these benefits may be offset by an increase in infectious deaths , particularly in those individuals with CD4(+ ) lymphocyte counts less than 50/mm(3 )",
"PURPOSE This phase II trial investigated the safety and efficacy of re-treatment with rituximab , a chimeric anti-CD20 monoclonal antibody , in patients with low- grade or follicular non-Hodgkin 's lymphoma who relapsed after a response to rituximab therapy . PATIENTS AND METHODS Fifty-eight patients were enrolled onto this study , and two were re-treated within the study . Patients received an intravenous infusion of 375 mg/m(2 ) of rituximab weekly for 4 weeks . All patients had at least two prior therapies and had received at least one prior course of rituximab , with a median interval of 14.5 months between rituximab courses . RESULTS Most adverse experiences ( AEs ) were transient grade 1 or 2 events occurring during the treatment period . Clinical ly significant myelosuppression was not observed ; hematologic toxicity was generally mild and reversible . No patient developed human antichimeric antibodies after treatment . The type , frequency , and severity of AEs in this study were not apparently different from those reported in the phase III trial of rituximab . The overall response rate in 57 assessable patients was 40 % ( 11 % complete response and 30 % partial responses ) . Median time to progression ( TTP ) in responders and median duration of response ( DR ) have not been reached , but Kaplan-Meier estimated medians are 17.8 months ( range , 5.4 + to 26.6 months ) and 16.3 months ( range , 3.7 + to 25.1 months ) , respectively . These estimated medians are longer than the medians achieved in the patients ' prior course of rituximab ( TTP and DR of 12.4 and 9.8 months , respectively , P : > .1 ) and in a previously reported phase III trial ( TTP in responders and DR of 13.2 and 11.6 months , respectively ) . Responses are ongoing in seven of 23 responders . CONCLUSION In this re-treatment population , safety and efficacy were not apparently different from those after initial rituximab exposure",
"PURPOSE Radioimmunotherapy combines biologic and radiolytic mechanisms to target and destroy tumor cells , thus offering a needed therapeutic alternative for refractory non-Hodgkin 's lymphoma ( NHL ) patients . This phase III r and omized study compares the novel radioimmunotherapy yttrium-90 ( (90)Y ) ibritumomab tiuxetan with a control immunotherapy , rituximab , in 143 patients with relapsed or refractory low- grade , follicular , or transformed CD20(+ ) transformed NHL . PATIENTS AND METHODS Patients received either a single intravenous ( IV ) dose of (90)Y ibritumomab tiuxetan 0.4 mCi/kg ( n = 73 ) or rituximab 375 mg/m(2 ) IV weekly for four doses ( n = 70 ) . The radioimmunotherapy group was pretreated with two rituximab doses ( 250 mg/m(2 ) ) to improve biodistribution and one dose of indium-111 ibritumomab tiuxetan for imaging and dosimetry . The primary end point , overall response rate ( ORR ) , was assessed by an independent , blinded , lymphoma expert panel . RESULTS ORR was 80 % for the (90)Y ibritumomab tiuxetan group versus 56 % for the rituximab group ( P = .002 ) . Complete response ( CR ) rates were 30 % and 16 % in the (90)Y ibritumomab tiuxetan and rituximab groups , respectively ( P = .04 ) . An additional 4 % achieved an unconfirmed CR in each group . Kaplan-Meier estimated median duration of response was 14.2 months in the (90)Y ibritumomab tiuxetan group versus 12.1 months in the control group ( P = .6 ) , and time to progression was 11.2 versus 10.1 months ( P = .173 ) in all patients . Durable responses of > or = 6 months were 64 % versus 47 % ( P = .030 ) . Reversible myelosuppression was the primary toxicity noted with (90)Y ibritumomab tiuxetan . CONCLUSION Radioimmunotherapy with (90)Y ibritumomab tiuxetan is well tolerated and produces statistically and clinical ly significant higher ORR and CR compared with rituximab alone",
"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",
"We investigated the feasibility , safety and efficacy of two B‐cell purging methods in patients with CD20 + non‐Hodgkin lymphoma ( NHL ) receiving autologous stsem cell transplantation . Myeloid and immune recoveries between the methods were compared . Twenty‐seven patients were r and omised to either in vivo purging with rituximab or ex vivo purging by CD34 + cell selection . Both purging methods were efficient at eliminating B‐cells in infusates . When compared with in vivo purging , ex vivo purging was associated with CD34 + cell loss and delayed median neutrophil ( 10 d vs. 11 d ) and platelet ( 12·5 d vs. 17 d ) count recoveries . Lymphocyte recovery was similar in both groups , but immunoglobulin recovery was delayed after in vivo purging . Late‐infectious complications were few in both arms . At a median follow‐up of 27 months , 2‐year probabilities of event‐free survival ( EFS ) rates were 81 % for in vivo purging and 76 % for ex vivo purging ( P = 0·66 ) . When compared with 53 unpurged patients , all 27 purged patients had improved 3‐year probabilities of overall survival ( 89 % vs. 70 % , P = 0·014 ) and a trend for improved EFS ( 78 % vs. 57 % , P = 0·075 ) . In conclusion , although both purging methods were feasible and safe , rituximab purging was superior as it did not impair CD34 + cell mobilisation and was associated with faster myeloid recovery . Further studies are needed to determine whether rituximab purging is more effective than the use of unpurged autografts",
"PURPOSE To compare the benefit of maintenance rituximab therapy versus rituximab re-treatment at progression in patients with previously treated indolent non-Hodgkin 's lymphoma . PATIENTS AND METHODS Between June 1998 and August 2002 , 114 patients who had received previous chemotherapy for indolent non-Hodgkin 's lymphoma were treated with a st and ard 4-week course of rituximab . Patients with objective response or stable disease were r and omly assigned to receive either maintenance rituximab therapy ( st and ard 4-week courses administered at 6-month intervals ) or rituximab re-treatment at the time of lymphoma progression . The duration of rituximab benefit was measured from the date of first rituximab treatment until the date other treatment was required . RESULTS Ninety ( 79 % ) of 114 patients had objective response or stable disease after initial rituximab treatment , and were r and omly assigned to treatment . Progression-free survival was prolonged in the maintenance group ( 31.3 v 7.4 months ; P = .007 ) . Final overall and complete response rates were higher in the maintenance group . Duration of rituximab benefit was similar in the maintenance and re-treatment groups ( 31.3 v 27.4 months , respectively ) . More maintenance patients remain in continuous remission , and more are currently in complete remission . Both treatment approaches were well tolerated . CONCLUSION In patients who have objective response or stable disease with single-agent rituximab therapy , duration of rituximab benefit is substantially prolonged with either scheduled maintenance treatment or rituximab re-treatment at the time of progression . At present , the magnitude of benefit with either approach appears similar . However , additional follow-up of this trial is required , and completion of phase III r and omized trials is necessary to definitively answer this question",
"PURPOSE Mantle cell lymphoma ( MCL ) is characterized by a poor prognosis with a low to moderate sensitivity to chemotherapy and a median survival of only 3 to 4 years . In an attempt to improve outcome , the German Low Grade Lymphoma Study Group ( GLSG ) initiated a r and omized trial comparing the combination of cyclophosphamide , doxorubicin , vincristine , and prednisone ( CHOP ) and rituximab ( R-CHOP ) with CHOP alone as first-line therapy for advanced-stage MCL . PATIENTS AND METHODS One hundred twenty-two previously untreated patients with advanced-stage MCL were r and omly assigned to six cycles of CHOP ( n = 60 ) or R-CHOP ( n = 62 ) . Patients up to 65 years of age achieving a partial or complete remission underwent a second r and omization to either myeloablative radiochemotherapy followed by autologous stem-cell transplantation or interferon alfa maintenance ( IFNalpha ) . All patients older than 65 years received IFNalpha maintenance . RESULTS R-CHOP was significantly superior to CHOP in terms of overall response rate ( 94 % v 75 % ; P = .0054 ) , complete remission rate ( 34 % v 7 % ; P = .00024 ) , and time to treatment failure ( TTF ; median , 21 v 14 months ; P = .0131 ) . No differences were observed for progression-free survival . Toxicity was acceptable , with no major differences between the two therapeutic groups . CONCLUSION The combined immunochemotherapy with R-CHOP result ed in a significantly higher response rate and a prolongation of the TTF as compared with chemotherapy alone . Hence , R-CHOP may serve as a new baseline regimen for advanced stage MCL , but needs to be further improved by novel strategies in remission",
"PURPOSE To address early and late treatment failures in older patients with diffuse large B-cell lymphoma ( DLBCL ) , we design ed a two-stage r and omized trial of cyclophosphamide , doxorubicin , vincristine , and prednisone ( CHOP ) versus rituximab plus CHOP ( R-CHOP ) , with a second r and om assignment to maintenance rituximab ( MR ) or observation in responding patients . PATIENTS AND METHODS Untreated DLBCL patients who were 60 years or older were r and omly assigned to R-CHOP ( n = 318 ) or CHOP ( n = 314 ) ; 415 responders were r and omly assigned to MR ( n = 207 ) or observation ( n = 208 ) . The primary end point was failure-free survival ( FFS ) . All P values were two sided . RESULTS Three-year FFS rate was 53 % for R-CHOP patients and 46 % for CHOP patients ( P = .04 ) at a median follow-up time of 3.5 years . Two-year FFS rate from second r and om assignment was 76 % for MR compared with 61 % for observation ( P = .009 ) . No significant differences in survival were seen according to induction or maintenance therapy . FFS was prolonged with MR after CHOP ( P = .0004 ) but not after R-CHOP ( P = .81 ) with 2-year FFS rates from second r and om assignment of 77 % , 79 % , 74 % , and 45 % for R-CHOP , R-CHOP + MR , CHOP + MR , and CHOP , respectively . In a secondary analysis excluding MR patients , R-CHOP alone reduced the risks of treatment failure ( P = .003 ) and death ( P = .05 ) compared with CHOP alone . CONCLUSION Rituximab administered as induction or maintenance with CHOP chemotherapy significantly prolonged FFS in older DLBCL patients . After R-CHOP , no benefit was provided by MR . These results , which are consistent with an additive effect of rituximab , suggest that future studies could focus on maintenance strategies with novel agents as well as new induction therapies",
"BACKGROUND Although many patients with intermediate- grade or high- grade ( aggressive ) non-Hodgkin 's lymphoma are cured by combination chemotherapy , the remainder are not cured and ultimately die of their disease . The Ann Arbor classification , used to determine the stage of this disease , does not consistently distinguish between patients with different long-term prognoses . This project was undertaken to develop a model for predicting outcome in patients with aggressive non-Hodgkin 's lymphoma on the basis of the patients ' clinical characteristics before treatment . METHODS Adults with aggressive non-Hodgkin 's lymphoma from 16 institutions and cooperative groups in the United States , Europe , and Canada who were treated between 1982 and 1987 with combination-chemotherapy regimens containing doxorubicin were evaluated for clinical features predictive of overall survival and relapse-free survival . Features that remained independently significant in step-down regression analyses of survival were incorporated into models that identified groups of patients of all ages and groups of patients no more than 60 years old with different risks of death . RESULTS In 2031 patients of all ages , our model , based on age , tumor stage , serum lactate dehydrogenase concentration , performance status , and number of extranodal disease sites , identified four risk groups with predicted five-year survival rates of 73 percent , 51 percent , 43 percent , and 26 percent . In 1274 patients 60 or younger , an age-adjusted model based on tumor stage , lactate dehydrogenase level , and performance status identified four risk groups with predicted five-year survival rates of 83 percent , 69 percent , 46 percent , and 32 percent . In both models , the increased risk of death was due to both a lower rate of complete responses and a higher rate of relapse from complete response . These two indexes , called the international index and the age-adjusted international index , were significantly more accurate than the Ann Arbor classification in predicting long-term survival . CONCLUSIONS The international index and the age-adjusted international index should be used in the design of future therapeutic trials in patients with aggressive non-Hodgkin 's lymphoma and in the selection of appropriate therapeutic approaches for individual patients",
"7502 Background : Rituximab ( R ) prolongs the progression-free survival ( PFS ) in patients with follicular lymphoma ( FL ) when given either simultaneously with or as maintenance after chemotherapy only . METHODS In the current study the impact of R maintenance after remission induction with an R-containing combined immuno-chemotherapy ( R-FCM ) was evaluated . Patients with advanced stage relapsed or refractory FL and mantle cell lymphoma ( MCL ) were eligible . The study design comprized 4 courses of chemotherapy with Fludarabine ( 25 mg/m2/d days 1 - 3 ) , Cyclophosphamide ( 200 mg/m2/d days 1 - 3 ) and Mitoxantrone ( 8 mg/m2/d day 1 ) ( FCM ) ± Rituximab ( 375 mg/m2/d day 0 ) . Patients entering a complete ( CR ) or partial remission ( PR ) underwent a second r and omization for R maintenance ( 4 weekly doses ( 375 mg/m2/d ) at three and nine months after end of induction ) or observation only . R and omization was stratified for histology , prior therapies ( up to 2 lines vs. > 2 ) , induction ( ±R ) , and response ( CR vs. PR ) . After improved outcome of the R-FCM arm had been observed in the initial 147 r and omized patients , all subsequent patients received a combined immuno-chemotherapy induction . RESULTS 176 of 195 r and omized cases are evaluable , 138 of whom had received an R-containing induction . In these patients ( as well as the total group ) the median PFS after end of induction has not been reached in the R-maintenance arm in contrast to 17 months in patients with no further treatment ( p = 0.001 ) . This improvement was seen both in FL ( n = 81 ; p = 0,035 ) and MCL ( n = 47 ; p = 0,049 ) . More importantly , overall survival rate was also improved after R maintenance with borderline significance ( 3 y rate 82 % vs. 55 % ; p = 0,056 ) . No major sided effects of R maintenance have been observed and the rate of serious infections was similar in both study arms ( p = 0.72 ) . CONCLUSIONS The final analysis of this study confirms that R maintenance after combined immuno-chemotherapy ( R-FCM ) is highly effective and improves the progression-free survival-with a strong trend towards improved overall survival-of patients with relapsed FL and MCL . [ Table : see text ]",
"Clinical study phase III B , prospect i ve r and omized trial . This phase III trial is a prospect i ve r and omized comparison of a combined immunochemotherapy [ mitoxantrone , chlorambucil , and prednisolone ( MCP ) plus rituximab ] versus chemotherapy ( MCP ) alone for previously untreated , advanced , treatment-dem and ing CD20positive indolent non-Hodgkin ’s lymphoma ( NHL ) and mantle cell lymphoma ( MCL ) . Open-label , two-arm study . Central r and omization by a clinical research organization ( CRO ) via fax . Inclusion",
"PURPOSE To evaluate the effect of single-agent rituximab given at the st and ard or a prolonged schedule in patients with newly diagnosed , or refractory or relapsed mantle cell lymphoma ( MCL ) . PATIENTS AND METHODS After induction treatment with the st and ard schedule ( 375 mg/m2 weekly x 4 ) , patients who were responding or who had stable disease at week 12 from the start of treatment were r and omly assigned to no further treatment ( arm A ) or prolonged rituximab administration ( 375 mg/m2 ) every 8 weeks for four times ( arm B ) . RESULTS The trial enrolled 104 patients . After induction , clinical response was 27 % with 2 % complete responses . Among patients with detectable t(11;14)-positive cells in blood and bone marrow at baseline , four of 20 , and one of 14 , respectively , became polymerase chain-reaction-negative after induction . Anemia was the only adverse predictor of response in the multivariate analysis . After a median follow-up of 29 months , response rate and duration of response were not significantly different between the two schedules in 61 r and omly assigned patients . Median event-free survival ( EFS ) was 6 months in arm A versus 12 months in arm B ; the difference was not significant ( P = .1 ) . Prolonged treatment seemed to improve EFS in the subgroup of pretreated patients ( 5 months in arm A v 11 months in arm B ; P = .04 ) . Thirteen percent of patients in arm A and 9 % in arm B presented with grade 3 to 4 hematologic toxicity . CONCLUSION Single-agent rituximab is active in MCL , but the addition of four single doses at 8-week intervals does not seem to significantly improve response rate , duration of response , or EFS after treatment with the st and ard schedule"
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BACKGROUND Attention deficit hyperactivity disorder ( ADHD ) is one of the most commonly diagnosed psychiatric disorders in childhood . A wide variety of treatments have been used for the management of ADHD . We aim ed to compare the efficacy and safety of pharmacological , psychological and complementary and alternative medicine interventions for the treatment of ADHD in children and adolescents . METHODS AND FINDINGS We performed a systematic review with network meta-analyses . R and omised controlled trials ( ≥ 3 weeks follow-up ) were identified from published and unpublished sources through search es in PubMed and the Cochrane Library ( up to April 7 , 2016 ) . Interventions of interest were pharmacological ( stimulants , non-stimulants , antidepressants , antipsychotics , and other unlicensed drugs ) , psychological ( behavioural , cognitive training and neurofeedback ) and complementary and alternative medicine ( dietary therapy , fatty acids , amino acids , minerals , herbal therapy , homeopathy , and physical activity ) . The primary outcomes were efficacy ( treatment response ) and acceptability ( all-cause discontinuation ) . Secondary outcomes included discontinuation due to adverse events ( tolerability ) , as well as serious adverse events and specific adverse events . R and om-effects Bayesian network meta-analyses were conducted to obtain estimates as odds ratios ( ORs ) with 95 % credibility intervals . We analysed interventions by class and individually . 190 r and omised trials ( 52 different interventions grouped in 32 therapeutic classes ) that enrolled 26114 participants with ADHD were included in complex networks . At the class level , behavioural therapy ( alone or in combination with stimulants ) , stimulants , and non-stimulant seemed significantly more efficacious than placebo . Behavioural therapy in combination with stimulants seemed superior to stimulants or non-stimulants . Stimulants seemed superior to behavioural therapy , cognitive training and non-stimulants . Behavioural therapy , stimulants and their combination showed the best profile of acceptability . Stimulants and non-stimulants seemed well tolerated . Among medications , methylpheni date , amphetamine , atomoxetine , guanfacine and clonidine seemed significantly more efficacious than placebo . Methylpheni date and amphetamine seemed more efficacious than atomoxetine and guanfacine . Methylpheni date and clonidine seemed better accepted than placebo and atomoxetine . Most of the efficacious pharmacological treatments were associated with harms ( anorexia , weight loss and insomnia ) , but an increased risk of serious adverse events was not observed . There is lack of evidence for cognitive training , neurofeedback , antidepressants , antipsychotics , dietary therapy , fatty acids , and other complementary and alternative medicine . Overall findings were limited by the clinical and method ological heterogeneity , small sample sizes of trials , short-term follow-up , and the absence of high- quality evidence ; consequently , results should be interpreted with caution . CONCLUSIONS Clinical differences may exist between the pharmacological and non-pharmacological treatment used for the management of ADHD . Uncertainties about therapies and the balance between benefits , costs and potential harms should be considered before starting treatment . There is an urgent need for high- quality r and omised trials of the multiple treatments for ADHD in children and adolescents . PROSPERO , number CRD42014015008
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"Background The treatment of children with attention deficit hyperactivity disorder ( ADHD ) and Tourette syndrome ( TS ) has been problematic because methylpheni date (MPH)—the most commonly used drug to treat ADHD — has been reported to worsen tics and because clonidine (CLON)—the most commonly prescribed alternative — has unproven efficacy . Methods The authors conducted a multicenter , r and omized , double-blind clinical trial in which 136 children with ADHD and a chronic tic disorder were r and omly administered CLON alone , MPH alone , combined CLON + MPH , or placebo ( 2 × 2 factorial design ) . Each subject participated for 16 weeks ( weeks 1–4 CLON/placebo dose titration , weeks 5–8 added MPH/placebo dose titration , weeks 9–16 maintenance therapy ) . Results Thirty-seven children were administered MPH alone , 34 were administered CLON alone , 33 were administered CLON + MPH , and 32 were administered placebo . For our primary outcome measure of ADHD ( Conners Abbreviated Symptom Question naire – Teacher ) , significant improvement occurred for subjects assigned to CLON ( p placebo , the greatest benefit occurred with combined CLON + MPH ( p for impulsivity and hyperactivity ; MPH appeared to be most helpful for inattention . The proportion of individual subjects reporting a worsening of tics as an adverse effect was no higher in those treated with MPH ( 20 % ) than those being administered CLON alone ( 26 % ) or placebo ( 22 % ) . Compared with placebo , measured tic severity lessened in all active treatment groups in the following order : CLON + MPH , CLON alone , MPH alone . Sedation was common with CLON treatment ( 28 % reported moderate or severe sedation ) , but otherwise the drugs were tolerated well , including absence of any evident cardiac toxicity . Conclusions Methylpheni date and clonidine ( particularly in combination ) are effective for ADHD in children with comorbid tics . Prior recommendations to avoid methylpheni date in these children because of concerns of worsening tics are unsupported by this trial",
"Correctable weaknesses in the design , conduct , and analysis of biomedical and public health research studies can produce misleading results and waste valuable re sources . Small effects can be difficult to distinguish from bias introduced by study design and analyses . An absence of detailed written protocol s and poor documentation of research is common . Information obtained might not be useful or important , and statistical precision or power is often too low or used in a misleading way . Insufficient consideration might be given to both previous and continuing studies . Arbitrary choice of analyses and an overemphasis on r and om extremes might affect the reported findings . Several problems relate to the research workforce , including failure to involve experienced statisticians and method ologists , failure to train clinical research ers and laboratory scientists in research methods and design , and the involvement of stakeholders with conflicts of interest . Inadequate emphasis is placed on recording of research decisions and on reproducibility of research . Finally , reward systems incentivise quantity more than quality , and novelty more than reliability . We propose potential solutions for these problems , including improvements in protocol s and documentation , consideration of evidence from studies in progress , st and ardisation of research efforts , optimisation and training of an experienced and non-conflicted scientific workforce , and reconsideration of scientific reward systems",
"BACKGROUND The effectiveness of a combined methylpheni date /behavioural treatment ( BT ) versus methylpheni date -only for Chinese children with Attention-Deficit/Hyperactivity Disorder ( ADHD ) was tested in routine clinical practice in Hong Kong . METHODS A r and omized group comparison design was adopted with two treatment conditions ( methylpheni date -only ; methylpheni date /BT ) , which lasted for 6 months . There were four assessment time points ( pre-treatment , post-treatment , and 6-month and 12-month follow-ups ) , using the Strengths and Weaknesses of ADHD Symptoms and Normal Behaviours ( SWAN ) Rating Scale . Parental attitude toward different treatment options of ADHD was also assessed at pre-treatment and post-treatment . Participants included 90 Chinese ADHD children ( mean age=8 years , SD=.95 ) . RESULTS The combination of BT and a low-dose methylpheni date was significantly more effective than methylpheni date -only in reducing ADHD and ODD symptoms at post-treatment . At follow-ups , the benefits of the combined treatment were maintained , while the methylpheni date -only group caught up in improvement in ADHD symptoms . Parents in both treatment conditions showed improved attitude toward medication after the 6-month treatment phase , while their attitude toward BT was positive all along . CONCLUSIONS This study supported the added benefits of BT , on top of medication , for Chinese ADHD children in routine practice with treatments conducted by regular medical and paramedical staffs",
"OBJECTIVE To test the hypotheses that in children with attention-deficit/hyperactivity disorder ( ADHD ) ( 1 ) symptoms of ADHD , oppositional defiant disorder , and overall functioning are significantly improved by methylpheni date combined with intensive multimodal psychosocial treatment compared with methylpheni date alone and with methylpheni date plus attention control and ( 2 ) more children receiving combined treatment can be taken off methylpheni date . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to short-term methylpheni date were r and omized for 2 years to ( 1 ) methylpheni date alone ; ( 2 ) methylpheni date plus psychosocial treatment that included parent training and counseling , social skills training , psychotherapy , and academic assistance , or ( 3 ) methylpheni date plus attention psychosocial control treatment . Assessment s included parent , teacher , and psychiatrist ratings , and observations in academic and gym classes . RESULTS Combination treatment did not lead to superior functioning and did not facilitate methylpheni date discontinuation . Significant improvement occurred across all treatments and continued over 2 years . CONCLUSIONS In stimulant-responsive children with ADHD , there is no support for adding ambitious long-term psychosocial intervention to improve ADHD and oppositional defiant disorder symptoms . Significant benefits from methylpheni date were stable over 2 years",
"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 ",
"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",
"Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field",
"BACKGROUND Previous studies have demonstrated the short-term efficacy of pharmacotherapy and behavior therapy for attention-deficit/hyperactivity disorder ( ADHD ) , but no longer-term ( i.e. , > 4 months ) investigations have compared these 2 treatments or their combination . METHODS A group of 579 children with ADHD Combined Type , aged 7 to 9.9 years , were assigned to 14 months of medication management ( titration followed by monthly visits ) ; intensive behavioral treatment ( parent , school , and child components , with therapist involvement gradually reduced over time ) ; the two combined ; or st and ard community care ( treatments by community providers ) . Outcomes were assessed in multiple domains before and during treatment and at treatment end point ( with the combined treatment and medication management groups continuing medication at all assessment points ) . Data were analyzed through intent-to-treat r and om-effects regression procedures . RESULTS All 4 groups showed sizable reductions in symptoms over time , with significant differences among them in degrees of change . For most ADHD symptoms , children in the combined treatment and medication management groups showed significantly greater improvement than those given intensive behavioral treatment and community care . Combined and medication management treatments did not differ significantly on any direct comparisons , but in several instances ( oppositional/aggressive symptoms , internalizing symptoms , teacher-rated social skills , parent-child relations , and reading achievement ) combined treatment proved superior to intensive behavioral treatment and /or community care while medication management did not . Study medication strategies were superior to community care treatments , despite the fact that two thirds of community-treated subjects received medication during the study period . CONCLUSIONS For ADHD symptoms , our carefully crafted medication management was superior to behavioral treatment and to routine community care that included medication . Our combined treatment did not yield significantly greater benefits than medication management for core ADHD symptoms , but may have provided modest advantages for non-ADHD symptom and positive functioning outcomes",
"Abstract Background The meaning of different components within a multimodal treatment of ADHD remains to be further clarified . Objective To evaluate the effectiveness of behaviour therapy and drug treatment within an adaptive and individually tailored multimodal treatment for children with ADHD . Method After an initial psychoeducation n = 75 school-children aged 6–10 years with a diagnosis of ADHD/HKD were assigned to either behaviour therapy ( including continued psychoeducation ) or medical management with methylpheni date plus psychoeducation . Depending on the effectiveness , the treatment was either terminated ( if totally effective ) with long – term aftercare and continuation of medication if needed , or ( if partially effective ) the other treatment component was added ( combined treatment ) , or ( if ineffective ) the treatment components were replaced . Thus a treatment rationale was applied which result ed in an adaptive and individually tailored therapy – similar to a strategy that may be useful in clinical practice . Results Of the children who started with behaviour therapy after initial psychoeducation 26 % received a combined treatment in later treatment stages . In most of the cases ( 82 % ) with initial medical management , behaviour therapy was added . ADHD symptoms , individually defined behaviour problems and comorbid symptoms were significantly reduced during the course of treatment . On core measures large pre – post effect sizes were found . On teacher ratings combined treatment was more effective than behaviour therapy . Conclusions Both , behaviour therapy and combined treatment are effective interventions within an adaptive and individually tailored multimodal treatment strategy",
"BACKGROUND : Although many efforts have been made to improve the quality of care delivered to children with attention-deficit/hyperactivity disorder ( ADHD ) in community-based pediatric setting s , little is known about typical ADHD care in these setting s other than rates garnered through pediatrician self-report . METHODS : Rates of evidence -based ADHD care and sources of variability ( practice -level , pediatrician-level , patient-level ) were determined by chart review s of a r and om sample of 1594 patient charts across 188 pediatricians at 50 different practice s. In addition , the associations of Medicaid-status and practice setting ( ie , urban , suburban , and rural ) with the quality of ADHD care were examined . RESULTS : Parent- and teacher-rating scales were used during ADHD assessment with approximately half of patients . The use of Diagnostic and Statistical Manual of Mental Disorders criteria was documented in 70.4 % of patients . The vast majority ( 93.4 % ) of patients with ADHD were receiving medication and only 13.0 % were receiving psychosocial treatment . Parent- and teacher-ratings were rarely collected to monitor treatment response or side effects . Further , fewer than half ( 47.4 % ) of children prescribed medication had contact with their pediatrician within the first month of prescribing . Most variability in pediatrician-delivered ADHD care was accounted for at the patient level ; however , pediatricians and practice s also accounted for significant variability on specific ADHD care behaviors . CONCLUSIONS : There is great need to improve the quality of ADHD care received by children in community-based pediatric setting s. Improvements will likely require systematic interventions at the practice and policy levels to promote change",
"Reporting harms may cause more trouble and discredit than the fame and glory associated with successful reporting of benefits ( 1 ) . The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement , a checklist ( Table 1 ) flow diagram first published in 1996 and revised 5 years later ( 2 , 3 ) , is an effort to st and ardize , and thereby improve , published reports of r and omized , controlled trials ( RCTs ) . One of the additions to the 2001 revision was an item about reporting adverse events . This single item did not do full justice to the importance of harms-related issues . The CONSORT Group met in September 2001 to discuss how to correct this deficiency . We aim ed to provide evidence -based guidance on the reporting of harms in RCTs . First , we search ed MEDLINE , EMBASE , Web of Science , and the Cochrane Library using a wide array of terms related to harms and identified pertinent evidence . We also communicated with experts and review ed bibliographies of identified articles to find additional studies . At a meeting in Montebello , Quebec , Canada , in May 2003 , CONSORT Group members , including several journal editors and additional experts in related fields , held a structured discussion of recommendations about reporting of harms-related issues in RCTs . The discussion s led to a written document that we circulated among the team members for comment . The present manuscript describes our recommendations on the appropriate reporting of harms in RCTs . Table 1 . Original CONSORT Checklist The terminology of harms-related issues in RCTs is confusing and often misleading or misused ( see Glossary ) ( 4 , 5 ) . Safety is a reassuring term that may obscure the real and potentially major harms that drugs and other interventions may cause . We encourage authors to use the term harms instead of safety . In addition to misused terminology , reporting of harms in RCTs has received less attention than reporting of efficacy and effectiveness and is often inadequate ( 6 - 14 ) . In short , both scientific evidence and ethical necessity call for action to improve the quality of reporting of harms in RCTs ( 15 , 16 ) . Here , we present a set of recommendations and accompanying explanations for the proper reporting of harms in RCTs . These recommendations should complement the existing CONSORT statement ( Table 2 ) . Examples are presented on the Annals and CONSORT ( www.consort-statement.org ) Web sites . Table 2 . Checklist of Items To Include When Reporting Harms in R and omized , Controlled Trials Recommendations Title and Abstract Recommendation 1 . If the study collected data on harms and benefits , the title or abstract should so state . The title should mention harms if the study of harms was a key trial objective . Many phase I and phase II trials , some phase II/III trials , and most phase IV trials ( 17 , 18 ) target harms as primary outcomes . Yet , the title and abstract seldom contain the word harm . Among 375143 entries in the Cochrane Central Register of Controlled Trials ( Cochrane Library , issue 3 , 2003 ) , search ing titles with the search terms harm or harms yielded 337 references ( compared with 55374 for efficacy and 23415 for safety ) . Of the 337 , excluding several irrelevant articles on self-harm or harm reduction , only 3 trial reports and 2 abstract s contained the word harm in their titles . Authors should present information on harms in the abstract . If no important harms occurred , authors should so state . Explicit reference to the reporting of adverse events in the title or abstract is also important for appropriate data base indexing and information retrieval ( 19 ) . Introduction Background Recommendation 2 . If the trial addresses both harms and benefits , the introduction should so state . The introduction states the scientific background and rationale of an RCT . This requires a balanced presentation whereby the possible benefits of the intervention under investigation are outlined along with the possible harms associated with the treatment . R and omized , controlled trials that focus primarily on harms should clearly state this interest when describing the study objectives in the Introduction and in defining these objectives in the Methods . Methods Outcomes Recommendation 3 . List addressed adverse events with definitions for each ( with attention , when relevant , to grading , expected vs. unexpected events , reference to st and ardized and vali date d definitions , and description of new definitions ) . The Methods section should succinctly define the recorded adverse events ( clinical and laboratory ) . Authors should clarify whether the reported adverse events encompass all the recorded adverse events or a selected sample . They should explain how , why , and who selected adverse events for reporting . In trials that do not mention harms-related data , the Methods section should briefly explain the reason for the omission ( for example , the design did not include the collection of any information on harms ) . Authors should also be explicit about separately reporting anticipated and unexpected adverse events . Expectation may influence the incidence of reported or ascertained adverse events . Making participants aware in the consent form of the possibility of a specific adverse event ( priming ) may increase the reporting rate of the event ( 20 ) . Another example of priming is the finding that the rates of withdrawals due to adverse events and the rates of specific adverse events were significantly higher in trials of aspirin , diclofenac , or indomethacin with comparator drugs compared with placebo-controlled trials ( 21 ) . Presumably , participants were more eager to come forth and report an adverse event or to withdraw from treatment when they knew they could not be receiving inactive placebo . Authors should report whether they used st and ardized and vali date d measurement instruments for adverse events . Several medical fields have developed st and ardized scales ( 22 - 32 ) . Use of nonvali date d scales is common . The source document for well-established definitions and scales should be referenced . New definitions for adverse events should be explicit and clear . Authors should describe how they developed and vali date d new scales . For interventions that target healthy individuals ( for example , many preventive interventions ) , any harm , however minor , may be important to capture and report because the balance of harms and benefits may easily lean toward harms in a low-risk population . For other population s and for interventions that improve major outcomes ( for example , survival ) , severe and life-threatening adverse events may be the only ones that are important in the balance of benefits and harms . Recommendation 4 . Clarify how harms-related information was collected ( mode of data collection , timing , attribution methods , intensity of ascertainment , and harms-related monitoring and stopping rules , if pertinent ) . It is important to describe the question naires , interviews , and tests used to collect information on harms , as well as their timing during follow-up . Passive surveillance of harms leads to fewer recorded adverse events than active surveillance ( 4 ) . Open-ended questions may yield different information , both quantitatively and qualitatively , than structured question naires ( 33 ) . Studies of nonsteroidal , anti-inflammatory drugs ( NSAIDs ) exemplify how data collection methods can affect the detection and reporting of harms . When selective NSAIDs with fewer gastrointestinal adverse events became available , trials reported more than 10 times as many ulcers when comparing these drugs with older NSAIDs as when older NSAIDs were compared with placebo . In the newer trials , more ulcers were detected because participants had regular endoscopy , and the case definition of ulcers was more sensitive ( 34 ) . Authors should specify the time frame of surveillance for adverse events . Some investigators stop recording adverse events at the end of the intervention period or a certain number of days afterward ( for example , 30 days after discontinuation of drug therapy ) and miss events with long latency ( 35 ) . Surgical trials often capture only the adverse events that occur intraoperatively . Several important surgical complications are likely to occur later . Finally , in crossover trials , delayed events might occur while the patient is taking a subsequent assigned treatment . Attribution is the process of deciding whether an adverse event is related to the intervention . Whenever authors filter events through an attribution process , they should state who makes the attribution ( investigators , participants , sponsors , or combinations ) , whether the process is blinded to assigned treatment , and what definitions of adverse events they use ( 4 ) . Discontinuations and withdrawals due to adverse events are especially important because they reflect the ultimate decision of the participant and /or physician to discontinue treatment . Although treatment may occasionally be discontinued for mild or moderate adverse events , attributing discontinuation to a specific reason ( to toxicity , lack of efficacy , other reasons , or combinations of reasons ) may be difficult . For example , in psychopharmacology , dropouts may reflect treatment ineffectiveness as much as toxicity-related intolerance ( 36 ) . Trial reports should specify who gave the reasons for discontinuation ( participants or physicians ) and whether attribution was blinded to the assigned treatment . For example , even in blinded trials , participants and their clinicians are often unblinded before they decide whether to discontinue the intervention . It is important to report participants who are nonadherent or lost to follow-up because their actions may reflect their inability to tolerate the intervention . Moreover , authors should specify how they h and led withdrawals in the analyses of the data . R and omized , controlled trials should report any plan for monitoring for harms and rules for stopping the trial because of harms ( 37 ) . They should clarify whether stopping guidelines examine benefits and harms",
"BACKGROUND The effects of a restricted elimination diet in children with attention-deficit hyperactivity disorder ( ADHD ) have mainly been investigated in selected subgroups of patients . We aim ed to investigate whether there is a connection between diet and behaviour in an unselected group of children . METHODS The Impact of Nutrition on Children with ADHD ( INCA ) study was a r and omised controlled trial that consisted of an open-label phase with masked measurements followed by a double-blind crossover phase . Patients in the Netherl and s and Belgium were enrolled via announcements in medical health centres and through media announcements . R and omisation in both phases was individually done by r and om sampling . In the open-label phase ( first phase ) , children aged 4 - 8 years who were diagnosed with ADHD were r and omly assigned to 5 weeks of a restricted elimination diet ( diet group ) or to instructions for a healthy diet ( control group ) . Thereafter , the clinical responders ( those with an improvement of at least 40 % on the ADHD rating scale [ ARS ] ) from the diet group proceeded with a 4-week double-blind crossover food challenge phase ( second phase ) , in which high-IgG or low-IgG foods ( classified on the basis of every child 's individual IgG blood test results ) were added to the diet . During the first phase , only the assessing paediatrician was masked to group allocation . During the second phase ( challenge phase ) , all persons involved were masked to challenge allocation . Primary endpoints were the change in ARS score between baseline and the end of the first phase ( masked paediatrician ) and between the end of the first phase and the second phase ( double-blind ) , and the abbreviated Conners ' scale ( ACS ) score ( unmasked ) between the same timepoints . Secondary endpoints included food-specific IgG levels at baseline related to the behaviour of the diet group responders after IgG-based food challenges . The primary analyses were intention to treat for the first phase and per protocol for the second phase . INCA is registered as an International St and ard R and omised Controlled Trial , number IS RCT N 76063113 . FINDINGS Between Nov 4 , 2008 , and Sept 29 , 2009 , 100 children were enrolled and r and omly assigned to the control group ( n=50 ) or the diet group ( n=50 ) . Between baseline and the end of the first phase , the difference between the diet group and the control group in the mean ARS total score was 23·7 ( 95 % CI 18·6 - 28·8 ; p the mean ACS score between the same timepoints was 11·8 ( 95 % CI 9·2 - 14·5 ; p score increased in clinical responders after the challenge by 20·8 ( 95 % CI 14·3 - 27·3 ; p ACS score increased by 11·6 ( 7·7 - 15·4 ; p foods , relapse of ADHD symptoms occurred in 19 of 30 ( 63 % ) children , independent of the IgG blood levels . There were no harms or adverse events reported in both phases . INTERPRETATION A strictly supervised restricted elimination diet is a valuable instrument to assess whether ADHD is induced by food . The prescription of diets on the basis of IgG blood tests should be discouraged . FUNDING Foundation of Child and Behaviour , Foundation Nuts Ohra , Foundation for Children 's Welfare Stamps Netherl and s , and the KF Hein Foundation",
"Objective The additional value of a short-term , clinical ly based , intensive multimodal behavior therapy to optimally titrated methylpheni date in children with attention-deficit hyperactivity disorder ( ADHD ) was investigated . Method Fifty children with ADHD ( ages 8–12 ) were r and omized to treatment of methylpheni date or treatment with methylpheni date combined with 10 weeks of multimodal behavior therapy . The multimodal behavior therapy consisted of a child and parent behavioral therapy and a teacher behavioral training . Assessment s included parent , teacher and child ratings of ADHD symptoms , oppositional and conduct behavior , social skills , parenting stress , anxiety and self-worth . Results Both treatment conditions yielded significant improvements on all outcome domains . No significant differences were found between both treatments . Conclusions No evidence was found for the additive effect of multimodal behavior therapy next to optimally titrated methylpheni date . Clinical implication sThis study does not support the expectation that optimally dosed stimulant treated children with ADHD should routinely receive psychosocial treatment to further reduce ADHD- and related symptoms",
"A pilot comparison of the safety and efficacy of methylpheni date ( MPH ) combined with clonidine , clonidine monotherapy , or MPH monotherapy in 6to 16-year-old children diagnosed with attention deficit hyperactivity disorder ( ADHD ) and comorbid aggressive oppositional defiant disorder or conduct disorder was completed . Study design was a 3-month , r and omized , blinded , group comparison with eight subjects per group . No placebo comparison was used . All three treatment groups showed significant improvements in attention deficits , impulsivity , oppositional , and conduct disordered symptoms as assessed by parent and teacher rating scales and laboratory measures . Significant differences among treatment groups were found only on a few measures . Only the clonidine monotherapy group showed significantly decreased fine motor speed . These results suggest the safety and efficacy of clonidine alone or in combination with MPH for the treatment of ADHD and aggressive oppositional and conduct disorders",
"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",
"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",
"OBJECTIVE To examine efficacy , tolerability , and safety of guanfacine extended release ( GXR ; ≤4 mg/d ) adjunctive to a long-acting psychostimulant for the treatment of attention-deficit/hyperactivity disorder ( ADHD ) in children and adolescents 6 to 17 years of age with suboptimal , but partial , response to psychostimulant alone . METHOD In this multicenter , 9-week , double-blind , placebo-controlled , dose-optimization study , subjects ( N = 461 ) continued their stable dose of psychostimulant given in the morning and were r and omized to receive GXR in the morning ( GXR AM ) , GXR in the evening ( GXR PM ) , or placebo . Efficacy measures included ADHD Rating Scale IV ( ADHD-RS-IV ) and Clinical Global Impressions of Severity of Illness ( CGI-S ) and Improvement ( CGI-I ) scales . Safety measures included adverse events ( AEs ) , vital signs , electrocardiograms , and laboratory evaluations . RESULTS At endpoint , GXR treatment groups showed significantly greater improvement from baseline ADHD-RS-IV total scores compared with placebo plus psychostimulant ( GXR AM , p = .002 ; GXR PM , p versus placebo plus psychostimulant were observed on the CGI-S ( GXR AM , p = .013 ; GXR PM , p and CGI-I ( GXR AM , p = .024 ; GXR PM , p = .003 ) . At endpoint , small mean decreases in pulse , systolic , and diastolic blood pressure were observed in GXR treatment groups versus placebo plus psychostimulant . No new safety signals emerged following administration of GXR with psychostimulants versus psychostimulants alone . Most AEs were mild to moderate in severity . CONCLUSIONS Morning or evening GXR administered adjunctively to a psychostimulant showed significantly greater improvement over placebo plus psychostimulant in ADHD symptoms and generated no new safety signals . Clinical trial registration information-Efficacy and Safety of SPD503 in Combination With Psychostimulants ; http://www . clinical trials.gov ; NCT00734578",
"OBJECTIVE : To assess the efficacy and safety of clonidine hydrochloride extended-release tablets ( CLON-XR ) combined with stimulants ( ie , methylpheni date or amphetamine ) for attention-deficit/hyperactivity disorder ( ADHD ) . PATIENTS AND METHODS : In this phase 3 , double-blind , placebo-controlled trial , children and adolescents with hyperactive- or combined-subtype ADHD who had an inadequate response to their stable stimulant regimen were r and omized to receive CLON-XR or placebo in combination with their baseline stimulant medication . Predefined efficacy measures evaluated change from baseline to week 5 . Safety was assessed by spontaneously reported adverse events , vital signs , electrocardiogram recordings , and clinical laboratory values . Improvement from baseline for all efficacy measures was evaluated using analysis of covariance . RESULTS : Of 198 patients r and omized , 102 received CLON-XR plus stimulant and 96 received placebo plus stimulant . At week 5 , greater improvement from baseline in ADHD Rating Scale IV ( ADHD-RS-IV ) total score ( 95 % confidence interval : −7.83 to −1.13 ; P = .009 ) , ADHD-RS-IV hyperactivity and inattention subscale scores ( P = .014 and P = .017 , respectively ) , Conners ' Parent Rating Scale scores ( P Clinical Global Impression of Severity ( P = .021 ) , Clinical Global Impression of Improvement ( P = .006 ) , and Parent Global Assessment ( P = .001 ) was observed in the CLON-XR plus stimulant group versus the placebo plus stimulant group . Adverse events and changes in vital signs in the CLON-XR group were generally mild . CONCLUSIONS : The results of this study suggest that CLON-XR in combination with stimulants is useful in reducing ADHD in children and adolescents with partial response to stimulants",
"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"
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BACKGROUND Cerebral injury and long-term neurodevelopmental impairment is common in extremely preterm infants . Cerebral near-infrared spectroscopy ( NIRS ) enables continuous estimation of cerebral oxygenation . This diagnostic method coupled with appropriate interventions if NIRS is out of normal range ( that is cerebral oxygenation within the 55 % to 85 % range ) may offer benefits without causing more harms . Therefore , NIRS coupled with appropriate responses to abnormal findings on NIRS needs assessment in a systematic review of r and omised clinical trials and quasi-r and omised studies . OBJECTIVES To evaluate the benefits and harms of interventions that attempt to alter cerebral oxygenation guided by cerebral NIRS monitoring in order to prevent cerebral injury , improve neurological outcome , and increase survival in preterm infants born more than 8 weeks preterm . SEARCH METHODS We used the st and ard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials ( CENTRAL 2016 , Issue 8) , MEDLINE via PubMed ( 1966 to 10 September 2016 ) , Embase ( 1980 to 10 September 2016 ) , and CINAHL ( 1982 to 10 September 2016 ) . We also search ed clinical trial data bases , conference proceedings , and the reference lists of retrieved articles for r and omised clinical trials and quasi-r and omised studies . SELECTION CRITERIA R and omised clinical trials and quasi-r and omised clinical studies comparing continuous cerebral NIRS monitoring for at least 24 hours versus blinded NIRS or versus no NIRS monitoring . DATA COLLECTION AND ANALYSIS Two review authors independently selected , assessed the quality of , and extracted data from the included trials and studies . If necessary , we contacted authors for further information . We conducted assessment s of risks of bias ; risks of design errors ; and controlled the risks of r and om errors with Trial Sequential Analysis . We assessed the quality of the evidence with GRADE . MAIN RESULTS One r and omised clinical trial met inclusion criteria , including infants born more than 12 weeks preterm . The trial employed adequate method ologies and was assessed at low risk of bias . One hundred and sixty-six infants were r and omised to start continuous cerebral NIRS monitoring less than 3 hours after birth until 72 hours after birth plus appropriate interventions if NIRS was out of normal range according to a guideline versus conventional monitoring with blinded NIRS . There was no effect of NIRS plus guideline of mortality until term-equivalent age ( RR 0.50 , 95 % CI 0.29 to 1.00 ; one trial ; 166 participants ) . There were no effects of NIRS plus guideline on intraventricular haemorrhages : all grade s ( RR 0.93 , 95 % CI 0.65 to 1.34 ; one trial ; 166 participants ) ; grade III/IV ( RR 0.57 , 95 % CI 0.25 to 1.31 ; one trial ; 166 participants ) ; and cystic periventricular leukomalacia ( which did not occur in either group ) . Likewise , there was no effect of NIRS plus guideline on the occurrence of a patent ductus arteriosus ( RR 1.96 , 95 % CI 0.94 to 4.08 ; one trial ; 166 participants ) ; chronic lung disease ( RR 1.27 , 95 % CI 0.94 to 1.50 ; one trial ; 166 participants ) ; necrotising enterocolitis ( RR 0.83 , 95 % CI 0.33 to 1.94 ; one trial ; 166 participants ) ; and retinopathy of prematurity ( RR 1.64 , 95 % CI 0.75 to 3.00 ; one trial ; 166 participants ) . There were no serious adverse events in any of the intervention groups . NIRS plus guideline caused more skin marks from the NIRS sensor in the control group than in the experimental group ( unadjusted RR 0.31 , 95 % CI 0.10 to 0.92 ; one trial ; 166 participants ) . There are no data regarding neurodevelopmental outcome , renal impairment or air leaks . The quality of evidence for all comparisons discussed above was assessed as very low apart from all-cause mortality and adverse events : these were assessed as low and moderate , respectively . The validity of all comparisons is hampered by a small sample of r and omised infants , risk of bias due to lack of blinding , and indirectness of outcomes . AUTHORS ' CONCLUSIONS The only eligible r and omised clinical trial did not demonstrate any consistent effects of NIRS plus a guideline on the assessed clinical outcomes . The trial was , however , only powered to detect difference in cerebral oxygenation , not morbidities or mortality . Our systematic review did not reach sufficient power to prove or disprove effects on clinical outcomes . Further r and omised clinical trials with low risks of bias and low risks of r and om errors are needed
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"OBJECTIVE The aim of this study was to evaluate the predictive value of cerebral regional oxygen saturation ( rSO(2 ) ) in the occurrence of postoperative cognitive dysfunction ( POCD ) in elderly patients undergoing coronary artery bypass graft ( CABG ) surgery . DESIGN A prospect i ve study . SETTING University hospital . PARTICIPANTS A total of 61 patients ( 84 % male ) with a mean age of 70.39 ± 4.69 on a waiting list for CABG surgery were enrolled in the study . INTERVENTION A complete neurocognitive evaluation was performed 1 day before surgery as well as 4 to 7 days and 1 month after surgery . During surgery , rSO(2 ) was monitored continuously . MEASUREMENTS AND MAIN RESULTS POCD was defined as a reduction of 1 st and ard deviation on 2 or more neuropsychologic indices . Forty-six patients ( 80.7 % ) developed early POCD , and 23 ( 38.3 % ) showed late POCD . Patients whose rSO(2 ) decreased to less than 50 % during the surgery experienced more POCD 4 to 7 days after surgery ( p = 0.04 ) . In addition , a decrease of more than 30 % from the patient 's baseline rSO(2 ) was associated with POCD 1 month after surgery ( p = 0.03 ) . CONCLUSION Intraoperative cerebral oxygen desaturation is associated with early and late POCD in elderly patients . Cerebral oximetry is a promising tool in the prediction of subtle neuropsychologic deficits and further studies are needed",
"Objective To determine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants monitored by cerebral near infrared spectroscopy ( NIRS ) oximetry . Design Phase II r and omised , single blinded , parallel clinical trial . Setting Eight tertiary neonatal intensive care units in eight European countries . Participants 166 extremely preterm infants born before 28 weeks of gestation : 86 were r and omised to cerebral NIRS monitoring and 80 to blinded NIRS monitoring . The only exclusion criterion was a decision not to provide life support . Interventions Monitoring of cerebral oxygenation using NIRS in combination with a dedicated treatment guideline during the first 72 hours of life ( experimental ) compared with blinded NIRS oxygenation monitoring with st and ard care ( control ) . Main outcome measures The primary outcome measure was the time spent outside the target range of 55 - 85 % for cerebral oxygenation multiplied by the mean absolute deviation , expressed in % hours ( burden of hypoxia and hyperoxia ) . One hour with an oxygenation of 50 % gives 5%hours of hypoxia . Secondary outcomes were all cause mortality at term equivalent age and a brain injury score assessed by cerebral ultrasonography . R and omisation Allocation sequence 1:1 with block sizes 4 and 6 in r and om order concealed for the investigators . The allocation was stratified for gestational age ( had a median burden of hypoxia and hyperoxia of 36.1%hours ( interquartile range 9.2 - 79.5%hours ) compared with 81.3 ( 38.5 - 181.3 ) % hours in the control group , a reduction of 58 % ( 95 % confidence interval 35 % to 73 % , P group the median burden of hypoxia was 16.6 ( interquartile range 5.4 - 68.1 ) % hours , compared with 53.6 ( 17.4 - 171.3 ) % hours in the control group ( P=0.0012 ) . The median burden of hyperoxia was similar between the groups : 1.2 ( interquartile range 0.3 - 9.6 ) % hours in the experimental group compared with 1.1 ( 0.1 - 23.4 ) % hours in the control group ( P=0.98 ) . We found no statistically significant differences between the two groups at term corrected age . No severe adverse reactions were associated with the device . Conclusions Cerebral oxygenation was stabilised in extremely preterm infants using a dedicated treatment guideline in combination with cerebral NIRS monitoring . Trial registration Clinical Trial.gov NCT01590316",
"BACKGROUND There are limited data to inform the choice between early treatment with continuous positive airway pressure ( CPAP ) and early surfactant treatment as the initial support for extremely-low-birth-weight infants . METHODS We performed a r and omized , multicenter trial , with a 2-by-2 factorial design , involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation . Infants were r and omly assigned to intubation and surfactant treatment ( within 1 hour after birth ) or to CPAP treatment initiated in the delivery room , with subsequent use of a protocol -driven limited ventilation strategy . Infants were also r and omly assigned to one of two target ranges of oxygen saturation . The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks ( with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30 % oxygen ) . RESULTS A total of 1316 infants were enrolled in the study . The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group ( 47.8 % and 51.0 % , respectively ; relative risk with CPAP , 0.95 ; 95 % confidence interval [ CI ] , 0.85 to 1.05 ) after adjustment for gestational age , center , and familial clustering . The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks ( rates of primary outcome , 48.7 % and 54.1 % , respectively ; relative risk with CPAP , 0.91 ; 95 % CI , 0.83 to 1.01 ) . Infants who received CPAP treatment , as compared with infants who received surfactant treatment , less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia ( P fewer days of mechanical ventilation ( P=0.03 ) , and were more likely to be alive and free from the need for mechanical ventilation by day 7 ( P=0.01 ) . The rates of other adverse neonatal outcomes did not differ significantly between the two groups . CONCLUSIONS The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants . ( Clinical Trials.gov number , NCT00233324 .",
"Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field",
"Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin ( rStO2 ) reflects venous oxygen saturation . If cerebral metabolism is stable , rStO2 can be used as an estimate of cerebral oxygen delivery . The SafeBoosC phase II r and omised clinical trial hypothesises that the burden of hypo- and hyperoxia can be reduced by the combined use of close monitoring of the cerebral rStO2 and a treatment guideline to correct deviations in rStO2 outside a predefined target range . Aims : To describe the rationale for and content of this treatment guideline . Methods : Review of the literature and assessment of the quality of evidence and the grade of recommendation for each of the interventions . Results and Conclusions : A clinical intervention algorithm based on the main determinants of cerebral perfusion-oxygenation changes during the first hours after birth was generated . The treatment guideline is presented to assist neonatologists in making decisions in relation to cerebral oximetry readings in preterm infants within the SafeBoosC phase II r and omised clinical trial . The evidence grade s were relatively low and the guideline can not be recommended outside a research setting",
"One cause of cerebral damage in comatose patients resuscitated from a cardiac arrest is cerebral ischaemia occurring during the postresuscitation period . Near‐infrared spectroscopy has been advocated as a useful monitor of brain oxygenation , but data on clinical use in comatose postarrest patients are not available . Therefore , we compared regional oxygen saturation measured with the INVOS 3100 with global oxygen saturation measured using jugular bulb oximetry in 10 comatose patients successfully resuscitated from an out‐of‐hospital cardiac arrest . Our data show that , in most patients , there is a significant difference between the two methods . The INVOS 3100 over‐read at low jugular bulb saturations ( in regional oxygen saturation . This increase was significantly correlated with the rise in cerebral blood flow and cardiac index , indicating that regional oxygen saturation is influenced by both cerebral and extracerebral components . We conclude that regional cerebral oxygen saturation measured with the INVOS 3100 can not be compared with global cerebral oxygen saturation measured with jugular bulb oximetry in comatose patients resuscitated from a cardiac arrest . This may be due to characteristics of the INVOS 3100 or to the distribution of cerebral blood flow after cardiac arrest",
"R and omized clinical trials ( RCTs ) have revolutionized medicine by providing evidence on the efficacy and safety of drugs , devices , and procedures . Today , more than 40 000 RCTs are reported annually , their quality continues to increase , and oversight mechanisms ensure adequate protection of participants . However , RCTs have at least 4 related problems : ( 1 ) they are too expensive and difficult ; ( 2 ) their findings are too broad ( average treatment effect not representative of benefit for any given individual ) and too narrow ( trial population and setting not representative of general practice ) ; ( 3 ) r and omizing patients can make patients and physicians uncomfortable , especially when comparing different types of existing care ; and ( 4 ) there are often long delays before RCT results diffuse into practice . The new alternative is “ big data . ” Because medical care is increasingly digitized in electronic health record ( EHR ) data sets and linked biological and genetic data banks , proponents suggest that health care systems are at the dawn of an era in which a patient ’s prognosis and optimal therapy will be generated from rapid analysis of these data sets using sophisticated machinelearning strategies . The information is relatively inexpensive , generated as a by-product of patient care ( overcoming the cost problem ) , and both specific to individuals ( ie , adequately narrow ) and , en masse , descriptive of the entire delivery system ( ie , adequately broad ) . No individuals are r and omized , so the ethical issues appear less complex . The richness and immediacy of these new data could allow tailored treatment decisions in real time , overcoming delays in knowledge translation . As such , although the RCT remains the gold st and ard for evaluation of experimental therapies , big data is proposed as a better approach for the broad swath of comparative effectiveness questions that arise in clinical practice . Indeed , the Institute of Medicine envisions big data as the engine for so-called learning health care systems.1 Yet big data is not a replacement for the RCT . The singular beauty of the RCT is the strength of causal inference that arises from r and om assignment . All known and unknown factors that can influence outcome , other than the treatment assignment , are distributed r and omly— and , if r and omization is effective , evenly — among the groups . Thus , any statistical difference in outcome between groups can be attributed to the assigned interventions . In contrast , big data exploits variation that may appear r and om but is not in fact r and omized . For example , big data may compare patients who did or did not receive a particular drug and then attempt to determine the extent to which any difference in patient outcome may be related to receiving the drug . However , for all the allure of inexpensive access to massive amounts of data , the Achilles ’ heel is lack of causal inference . No matter how detailed the measurement and how sophisticated the adjustment for all known variables , big data can not eliminate unmeasured factors coincident with a particular treatment assignment that could explain an apparent change in outcome .2 Thus , each approach has complementary strengths : RCTs offer causal inference , and big data offers the potential for low-cost , high-volume , nuanced answers with immediate feedback . Rather than debate which is better , the greatest promise may come from fusing them",
"Objective To compare the cerebral tissue oxygenation index ( TOI ) measured by near-infrared spectroscopy ( NIRS ) with venous oxygen saturation in the jugular bulb ( SjO2 ) during elective cardiac catheterization in children . Design and setting Prospect i ve observational clinical study in a catheterization laboratory for pediatric cardiology . Patients Sixty children with congenital heart defects admitted to the catheterization laboratory . Measurements and results TOI measured noninvasively by NIRS was compared to SjO2 measured in the jugular bulb during cardiac catheterization . Patients were divided into two groups regarding body weight : below ( n=29 ) and above 10 kg ( n=31 ) . Linear regression analysis and Pearson ’s correlation coefficient were calculated . Bl and -Altman analysis , sensitivity , and specificity calculation for spatially resolved near-infrared spectroscopy with a cutoff level of 60 % were performed . Simultaneously measured values for SjO2 ( 67.3±9.8 % , 40–84.1 % ) and TOI ( 65.7±7.2 % , 39–80 % ) showed a significant correlation ; the correlation in children weighing under 10 kg was stronger in children weighing over 10 kg . Bl and -Altman analysis showed a mean bias of −1.8 % with limits of agreement between 11.7 % and −15.3 % for all children . Sensitivity and specificity of the SRS method were 46 % and 91 % , respectively , for all children and 53 % and 83 % respectively in infants weighing under 10 kg . Conclusions The results demonstrate that despite a significant correlation , sensitivity of spatially resolved spectroscopy is poor , and it is question able whether TOI can be used reliably to detect low SjO2 ",
"OBJECTIVE To determine the optimal timing of cranial ultrasound scans ( USs ) for identifying preterm neonates weighing less than 1500 g at birth who develop intracranial complications of prematurity . DESIGN / SETTING Observational study at an urban county hospital . METHODS Serial USs from neonates with less than 1500-g birth weight ( BW ) admitted to the neonatal intensive care unit between January 1995 and December 1996 were review ed by a pediatric neuroradiologist in a blinded r and om manner . RESULTS Two hundred forty-eight neonates ( 78 % ) underwent at least 3 USs , 32 ( 10 % ) had 2 USs and 37 ( 12 % ) only 1 US . The initial US was normal in 156 neonates ( 49 % ) and abnormal in 161 ( 57 % ) . The principal abnormalities included intraventricular hemorrhage ( IVH ) ( n = 74 ) , periventricular echogenicity ( PVE ) ( n = 68 ) , ventriculomegaly ( n = 7 ) , and solitary cysts ( n = 9 ) . Severe IVH ( n = 17 ) occurred in 13 ( 11.4 % ) of 114 neonates at less than 1000-g BW and 4 ( 5 % ) of 79 neonates of BW 1000 to 1250 g. In 11 cases ( 65 % ) , the severe IVH was clinical ly unsuspected . For neonates weighing less than 1000 g , IVH was diagnosed by days 3 to 5 in 10 ( 77 % ) of 13 , by days 10 to 14 in 11 ( 84 % ) of 13 , and by day 28 in all neonates ; for neonates 1001 to 1250 g , IVH was diagnosed in 1 ( 24 % ) of 4 by days 3 to 5 , 2 ( 50 % ) of 4 by days 10 to 14 , and 3 ( 75 % ) of 4 by day 28 . One infant 's condition was diagnosed on routine US before discharge from the hospital . Cystic periventricular leukomalacia ( PVL ) was noted in 9 neonates ; in 4 of the 9 cases , increased PVE was present on the initial US and cyst formation was obvious by the second US . For 4 neonates ( 3 with BW cystic PVL was noted on the predischarge US in these cases . Nonobstructive ventriculomegaly in the absence of IVH or cystic PVL was observed in 14 neonates . In 6 , it was noted on the initial screening US ; in 4 of the cases , it evolved after the third screening US . Two hundred fifty-six neonates had a US before discharge from the hospital ; 181 ( 72 % ) were normal and 75 ( 28 % ) abnormal . Nine significant lesions were identified by the US before discharge from the hospital ( ie , severe IVH [ n = 1 ] , cystic PVL [ n = 4 ] , and ventriculomegaly [ n = 4 ] ) . CONCLUSIONS The following screening protocol is recommended : ( 1 ) Neonates of less than 1000-g BW : initial US on days 3 to 5 ( should identify at least 75 % of cases of IVH and some PVE abnormalities ) ; second US on days 10 to 14 ( should detect at least 84 % of IVH and identify early hydrocephalus and early cyst formation ) ; third scan on day 28 ( should detect all cases of IVH , as well as assess PVE and ventricular size ) ; and final scan before discharge from the hospital ( should detect approximately 20 % of significant late-onset lesions ) . ( 2 ) Neonates of 1000- to 1250-g BW : initial US at days 3 to 5 ( should detect at least 40 % of significant abnormalities ) ; a second scan at day 28 ( should detect at least 70 % of significant abnormalities ) ; and a predischarge scan ( should detect all late-onset significant lesions ) . ( 3 ) Neonates of 1251- to 1500-g BW : an initial scan at days 3 to 5 ; and a second scan before discharge from the hospital if the clinical course is complicated . Arch Pediatr Adolesc Med . 2000;154:822 -",
"Background : The SafeBoosC phase II multicentre r and omized clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy ( NIRS ) combined with an evidence -based treatment guideline vs. no NIRS data and treatment as usual in the control group during the first 72 h of life . The trial demonstrated a significant reduction in the burden of cerebral hypoxia in the experimental group . We now report the blindly assessed and analyzed treatment effects on electroencephalographic ( EEG ) outcomes ( burst rate and spectral edge frequency 95 % ( SEF95 ) ) and blood biomarkers of brain injury ( S100β , brain fatty acid-binding protein , and neuroketal ) . Methods : One hundred and sixty-six extremely preterm infants were r and omized to either experimental or control group . EEG was recorded at 64 h of age and blood sample s were collected at 6 and 64 h of age . Results : One hundred and thirty-three EEGs were evaluated . The two groups did not differ regarding burst rates ( experimental 7.2 vs. control 7.7 burst/min ) or SEF95 ( experimental 18.1 vs. control 18.0 Hz ) . The two groups did not differ regarding blood S100β , brain fatty acid-binding protein , and neuroketal concentrations at 6 and 64 h ( n = 123 participants ) . Conclusion : Treatment guided by NIRS reduced the cerebral burden of hypoxia without affecting EEG or the selected blood biomarkers",
"INTRODUCTION The research programme Safeguarding the Brains of our smallest Children ( SafeBoosC ) aims to test the benefits and harms of cerebral near-infrared spectroscopy ( NIRS ) oximetry in infants born before 28 weeks of gestation . In a phase II trial , infants will be r and omised to visible cerebral NIRS oximetry with pre-specified treatment guidelines compared to st and ard care with blinded NIRS-monitoring . The primary outcome is duration multiplied with the extent outside the normal range of regional tissue oxygen saturation of haemoglobin ( rStO2 ) of 55 to 85 % in percentage hours ( burden ) . This study was a pilot of the Visible -Oximetry Group . MATERIAL AND METHODS This was an observational study including ten infants . RESULTS The median gestational age was 26 weeks+three days , and the median start-up time was 133 minutes after delivery . The median recording time was 69.7 hours , mean rStO2 was 64.2±4.5 % , median burden of hyper- and hypoxia was 30.3 % hours ( range 2.8 - 112.3 ) . Clinical staff responded to an out of range value 29 times -- only once to values above 85 % . In comparison , there were 83 periods of more than ten minutes with an rStO2 below 55 % and four episodes with an rStO2 above 85 % . These periods accounted for 72 % of the total hypoxia burden . A total of 18 of the 29 interventions were adjustments of FiO2 which in 13 of the 18 times result ed in an out-of-range SpO2 . Two infants suffered second-degree burns from the sensor . Five infants died . In all cases , this was unrelated to NIRS monitoring and treatment . CONCLUSION The intervention of early cerebral NIRS monitoring proved feasible , but prolonged periods of hypoxia went untreated . Thus , a revision of the treatment guideline and an alarm system is required . FUNDING The Elsass Foundation funded the present study . TRIAL REGISTRATION Clinical trials.gov : NCT01530360",
"Background Every year in Europe about 25,000 infants are born extremely preterm . These infants have a 20 % mortality rate , and 25 % of survivors have severe long-term cerebral impairment . Preventative measures are key to reduce mortality and morbidity in an extremely preterm population . The primary objective of the SafeBoosC phase II trial is to examine if it is possible to stabilize the cerebral oxygenation of extremely preterm infants during the first 72 hours of life through the application of cerebral near-infrared spectroscopy ( NIRS ) oximetry and implementation of an clinical treatment guideline based on intervention thresholds of cerebral regional tissue saturation rStO2 . Methods / Design SafeBoosC is a r and omized , blinded , multinational , phase II clinical trial . The inclusion criteria are : neonates born more than 12 weeks preterm ; decision to conduct full life support ; parental informed consent ; and possibility to place the cerebral NIRS oximeter within 3 hours after birth . The infants will be r and omized into one of two groups . Both groups will have a cerebral oximeter monitoring device placed within three hours of birth . In the experimental group , the cerebral oxygenation reading will supplement the st and ard treatment using a predefined treatment guideline . In the control group , the cerebral oxygenation reading will not be visible and the infant will be treated according to the local st and ards . The primary outcome is the multiplication of the duration and magnitude of rStO2 values outside the target ranges of 55 % to 85 % , that is , the ‘ burden of hypoxia and hyperoxia ’ expressed in ‘ % hours ’ . To detect a 50 % difference between the experimental and control group in % hours , 166 infants in total must be r and omized . Secondary outcomes are mortality at term date , cerebral ultrasound score , and interburst intervals on an amplitude-integrated electroencephalogram at 64 hours of life and explorative outcomes include neurodevelopmental outcome at 2 years corrected age , magnetic resonance imaging at term , blood biomarkers at 6 and 64 hours after birth , and adverse events . Discussion Cerebral oximetry guided interventions have the potential to improve neurodevelopmental outcome in extremely preterm infants . It is a logical first step to test if it is possible to reduce the burden of hypoxia and hyperoxia . Trial registration Clinical Trial.gov ,",
"CONTEXT Controversy and uncertainty ensue when the results of clinical research on the effectiveness of interventions are subsequently contradicted . Controversies are most prominent when high-impact research is involved . OBJECTIVES To underst and how frequently highly cited studies are contradicted or find effects that are stronger than in other similar studies and to discern whether specific characteristics are associated with such refutation over time . DESIGN All original clinical research studies published in 3 major general clinical journals or high-impact-factor specialty journals in 1990 - 2003 and cited more than 1000 times in the literature were examined . MAIN OUTCOME MEASURE The results of highly cited articles were compared against subsequent studies of comparable or larger sample size and similar or better controlled design s. The same analysis was also performed comparatively for matched studies that were not so highly cited . RESULTS Of 49 highly cited original clinical research studies , 45 cl aim ed that the intervention was effective . Of these , 7 ( 16 % ) were contradicted by subsequent studies , 7 others ( 16 % ) had found effects that were stronger than those of subsequent studies , 20 ( 44 % ) were replicated , and 11 ( 24 % ) remained largely unchallenged . Five of 6 highly-cited nonr and omized studies had been contradicted or had found stronger effects vs 9 of 39 r and omized controlled trials ( P = .008 ) . Among r and omized trials , studies with contradicted or stronger effects were smaller ( P = .009 ) than replicated or unchallenged studies although there was no statistically significant difference in their early or overall citation impact . Matched control studies did not have a significantly different share of refuted results than highly cited studies , but they included more studies with \" negative \" results . CONCLUSIONS Contradiction and initially stronger effects are not unusual in highly cited research of clinical interventions and their outcomes . The extent to which high citations may provoke contradictions and vice versa needs more study . Controversies are most common with highly cited nonr and omized studies , but even the most highly cited r and omized trials may be challenged and refuted over time , especially small ones",
"Background : The current study was design ed to determine the relation between preoperative cerebral oxygen saturation ( Sco2 ) , variables of cardiopulmonary function , mortality , and morbidity in a heterogeneous cohort of cardiac surgery patients . Methods : In this study , 1,178 consecutive patients scheduled for on-pump surgery were prospect ively studied . Preoperative Sco2 , demographics , N-terminal pro-B-type natriuretic peptide , high-sensitive troponin T , clinical outcomes , and 30-day and 1-yr mortality were recorded . Results : Median additive EuroSCORE was 5 ( range : 0–19 ) . Thirty-day and 1-yr mortality and major morbidity ( at least two major complications and /or a high-dependency unit stay of at least 10 days ) were 3.5 % , 7.7 % , and 13.3 % , respectively . Median minimal preoperative oxygen supplemented Sco2 ( Sco2min-ox ) was 64 % ( range : 15–92 % ) . Sco2min-ox was correlated ( all : P value N-terminal pro-B-type natriuretic peptide ( & rgr ; : −0.35 ) , high-sensitive troponin T ( & rgr ; : −0.28 ) , hematocrit ( & rgr ; : 0.34 ) , glomerular filtration rate ( & rgr ; : 0.19 ) , EuroSCORE ( & tgr ; : 0.20 ) , and left ventricular ejection fraction class ( & tgr ; : 0.12 ) . Thirty-day nonsurvivors had a lower Sco2min-ox than survivors ( median 58 % [ 95 % CI , 50.7–62 % ] vs. 64 % [ 95 % CI , 64–65 % ] ; P of Sco2min-ox and 30-day mortality revealed an area-under-the-curve of 0.71 ( 95 % CI , 0.68–0.73 % ; P patients with a EuroSCORE more than 10 . Logistic regression based on different EuroSCORE categories ( 0–2 ; 3–5 , 6–10 , > 10 ) , Sco2min-ox , and duration of cardiopulmonary bypass showed that a Sco2min-ox equal or less than 50 % is an independent risk factor for 30-day and 1-yr mortality . Conclusions : Preoperative Sco2 levels are reflective of the severity of cardiopulmonary dysfunction , associated with short- and long-term mortality and morbidity , and may add to preoperative risk stratification in patients undergoing cardiac surgery",
"BACKGROUND : Cerebral deoxygenation is associated with various adverse systemic outcomes . We hypothesized , by using the brain as an index organ , that interventions to improve cerebral oxygenation would have systemic benefits in cardiac surgical patients . METHODS : Two-hundred coronary artery bypass patients were r and omized to either intraoperative cerebral regional oxygen saturation ( rSO2 ) monitoring with active display and treatment intervention protocol ( intervention , n = 100 ) , or underwent blinded rSO2 monitoring ( control , n = 100 ) . Predefined clinical outcomes were assessed by a blinded observer . RESULTS : Significantly more patients in the control group demonstrated prolonged cerebral desaturation ( P = 0.014 ) and longer duration in the intensive care unit ( P = 0.029 ) versus intervention patients . There was no difference in overall incidence of adverse complications , but significantly more control patients had major organ morbidity or mortality ( death , ventilation > 48 h , stroke , myocardial infa rct ion , return for re-exploration ) versus intervention group patients ( P = 0.048 ) . Patients experiencing major organ morbidity or mortality had lower baseline and mean rSO2 , more cerebral desaturations and longer lengths of stay in the intensive care unit and postoperative hospitalization , than patients without such complications . There was a significant ( r2 = 0.29 ) inverse correlation between intraoperative rSO2 and duration of postoperative hospitalization in patients requiring ≥10 days postoperative length of stay . CONCLUSION : Monitoring cerebral rSO2 in coronary artery bypass patients avoids profound cerebral desaturation and is associated with significantly fewer incidences of major organ dysfunction",
"Objective : To determine the rate and severity of short- and long-term morbidity in very low birth weight infants treated before and after the implementation of a change in clinical practice design ed to avoid hyperoxia . Methods : Analysis of a prospect ively collected data base of all infants ⩽1250 g admitted to two Emory University NICU 's from January 2000 to December 2004 . A change in practice was instituted in January 2003 with the objective of avoiding hyperoxia in preterm infants with target O2 saturation ( SpO2 ) at 93 to 85 % ( Period II ) . Before the change in practice , SpO2 high alarms were set at 100 % and low alarms at 92 % ( Period I ) . Statistical analysis included bivariate analyses and multivariate logistic regression comparing outcomes between the two periods . Results : From January 2000 to December 2004 , 502 infants met enrollment criteria and 202 ( 40 % ) were born in period II , after change in SpO2 targets . Birth weight , gestational age and survival were similar between both periods . The rates for any retinopathy of prematurity , supplemental oxygen at 36 weeks post-conceptional age and the use of steroids for chronic lung disease were significantly lower in the infants born in Period II . There was no difference in the rates of necrotizing enterocolitis , intraventricular hemorrhage and periventricular leukomalacia . At 18 months corrected age ( CA ) , the infants treated during Period II had a higher Mental Developmental Index ( MDI ) scores ( 80.2±18.3 vs 89.2±18.5 ; P 0.02 ) and similar Psychomotor Developmental Index ( PDI ) scores ( 83.9±18.6 vs 89.4±17.2 ; P 0.08 ) than those treated during Period I. The proportion of infants with an MDI or a PDI less than 70 was similar between the periods . Conclusions : The change in practice to avoid hyperoxia is associated with a significant decrease in neonatal morbidity and does not have a detrimental effect on developmental outcomes at 18 months CA",
"BACKGROUND Previous studies have reported an 11 % to 75 % incidence of postoperative cognitive decline among cardiac surgery patients . The INVOS Cerebral Oximeter ( Somanetics Corp , Troy , MI ) is a Food and Drug Administration approved device that measures regional cerebral oxygen ( rSo(2 ) ) saturation . The purpose of this study is to examine whether decreased rSo(2 ) predicts cognitive decline and prolonged hospital stay after coronary artery bypass grafting ( CABG ) . METHODS The rSo(2 ) was monitored intraoperatively in a cohort of primary CABG patients . Patients were prospect ively r and omized to a blinded control group or an unblinded intervention group . Cognitive function was assessed preoperatively , postoperatively , and at 3 months using a battery of st and ardized neurocognitive tests . Cognitive decline was defined as a decrease of one st and ard deviation or more in performance on at least one neurocognitive measure . The rSo(2 ) desaturation score was calculated by multiplying rSo(2 ) below 50 % by time ( seconds ) . Multivariate logistic regression models were used to assess cognitive decline and hospital stay . The change in cognitive performance was also assessed using a multivariate linear regression model . RESULTS Patients with rSo(2 ) desaturation score greater than 3,000%-second had a significantly higher risk of early postoperative cognitive decline [ p = 0.024 ] . Patients with rSo(2 ) desaturation score greater than 3,000%-second also had a near threefold increased risk of prolonged hospital stay ( > 6 days ) [ p = 0.007 ] . CONCLUSIONS Intraoperative cerebral oxygen desaturation is significantly associated with an increased risk of cognitive decline and prolonged hospital stay after CABG",
"Elderly patients are more prone than younger patients to develop cerebral desaturation because of the reduced physiologic reserve that accompanies aging . To evaluate whether monitoring cerebral oxygen saturation ( rSO2 ) minimizes intraoperative cerebral desaturation , we prospect ively monitored rSO2 in 122 elderly patients undergoing major abdominal surgery with general anesthesia . Patients were r and omly allocated to an intervention group ( the monitor was visible and rSO2 was maintained at ≥75 % of preinduction values ; n = 56 ) or a control group ( the monitor was blinded and anesthesia was managed routinely ; n = 66 ) . Cerebral desaturation ( rSO2 reduction P = 0.82 ) . Mean ( 95 % confidence intervals ) values of mean rSO2 were higher ( 66 % [ 64%–68 % ] ) and the area under the curve below 75 % of baseline ( AUCrSO22 developing intraoperative cerebral desaturation , a lower Mini Mental State Elimination ( MMSE ) score was observed at the seventh postoperative day in the control group ( 26 [ 25–30 ] ) than in the treatment group ( 28 [ 26–30 ] ) ( P = 0.02 ) , with a significant correlation between the AUCrSO2 % of baseline and postoperative decrease in MMSE score from preoperative values ( r2= 0.25 , P = 0.01 ) . Patients of the control group with intraoperative cerebral desaturation also experienced a longer time to postanesthesia care unit ( PACU ) discharge ( 47 min [ 13–56 min ] ) and longer hospital stay ( 24 days [ 7–53 ] days ) compared with patients of the treatment group ( 25 min [ 15–35 min ] and 10 days [ 7–23 days ] , respectively ; P = 0.01 and P = 0.007 ) . Using rSO2 monitoring to manage anesthesia in elderly patients undergoing major abdominal surgery reduces the potential exposure of the brain to hypoxia ; this might be associated with decreased effects on cognitive function and shorter PACU and hospital stay",
"Background : Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes . Before a large multicenter r and omized controlled trial ( RCT ) on the impact of preventing desaturations on perioperative outcomes , the authors undertook a r and omized prospect i ve , parallel-arm , multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations . Methods : Eight Canadian sites r and omized 201 patients between April 2012 and October 2013 . The primary outcome was the success rate of reversing cerebral desaturations below 10 % relative to baseline in the intervention group . Anesthesiologists were blinded to the cerebral saturation values in the control group . Intensive care unit personnel were blinded to cerebral saturation values for both groups . Secondary outcomes included the area under the curve of cerebral desaturation load , enrolment rates , and a 30-day follow-up for adverse events . Results : Cerebral desaturations occurred in 71 ( 70 % ) of the 102 intervention group patients and 56 ( 57 % ) of the 99 control group patients ( P = 0.04 ) . Reversal was successful in 69 ( 97 % ) of the intervention group patients . The mean cerebral desaturation load ( SD ) in the operating room was smaller for intervention group patients compared with control group patients ( 104 [ 217 ] % .min vs. 398 [ 869 ] % .min , mean difference , −294 ; 95 % CI , −562 to −26 ; P = 0.03 ) . This was also true in the intensive care unit ( P = 0.02 ) . There were no differences in adverse events between the groups . Conclusions : Study sites were successful in reversal of desaturation , patient recruitment , r and omization , and follow-up in cardiac surgery , supporting the feasibility of conducting a large multicenter RCT",
"OBJECTIVE To assess if monitoring of cerebral regional tissue oxygen saturation ( crSO2 ) using near-infrared spectroscopy ( NIRS ) to guide respiratory and supplemental oxygen support reduces burden of cerebral hypoxia and hyperoxia in preterm neonates during resuscitation after birth . STUDY DESIGN Preterm neonates were included in a prospect i ve r and omized controlled pilot feasibility study at 2 tertiary level neonatal intensive care units . In a NIRS-visible group , crSO2 monitoring in addition to pulse oximetry was used to guide respiratory and supplemental oxygen support during the first 15 minutes after birth . In a NIRS-not-visible group , only pulse oximetry was used . The primary outcomes were burden of cerebral hypoxia ( 90th percentile ) measured in % minutes crSO2 during the first 15 minutes after birth . Secondary outcomes were all cause of mortality and /or cerebral injury and neurologic outcome at term age . Allocation sequence was 1:1 with block-r and omization of 30 preterm neonates at each site . RESULTS In the NIRS-visible group burden of cerebral hypoxia in % minutes , crSO2 was halved , and the relative reduction was 55.4 % ( 95 % CI 37.6 - 73.2 % ; P = .028 ) . Cerebral hyperoxia was observed in NIRS-visible group in 3 neonates with supplemental oxygen and in NIRS-not-visible group in 2 . Cerebral injury rate and neurologic outcome at term age was similar in both groups . Two neonates died in the NIRS-not-visible group and none in the NIRS-visible group . No severe adverse reactions were observed . CONCLUSIONS Reduction of burden of cerebral hypoxia during immediate transition and resuscitation after birth is feasible by crSO2 monitoring to guide respiratory and supplemental oxygen support . TRIAL REGISTRATION Clinical Trials.gov : NCT02017691",
"BACKGROUND Near-infrared spectroscopy is a developing technique for monitoring cerebral oxygenation during anaesthesia . The aim of this study was to evaluate absolute values of cerebral oxygenation during stable anaesthesia conditions in otherwise healthy children using the recently introduced INVOS 5100 cerebral oximeter with a paediatric and adult sensor and to compare them with values obtained from the NIRO 300 oximeter . METHODS Thirty paediatric surgical patients ( aged 0.23 - 15.97 years ) were studied during general anaesthesia with tracheal intubation and controlled ventilation . Comparative measurements of cerebral oxygenation were performed on the forehead with two probes within 10 min under stable cardiorespiratory and anaesthesia conditions . Cerebral oxygenation values ( rSO2 ) obtained from the paediatric and adult INVOS 5100 sensors were compared with the tissue oxygenation index ( TOI ) obtained from the NIRO 300 cerebral oximeter using 4- and 5-cm emitter-detector separation . RESULTS Cerebral rSO2 values and the TOI values both showed a large range of cerebral oxygenation in the children studied ( rSO2 : 59 - 95 % , TOI : 48 - 85 % ) . Cerebral rSO2 values measured by the INVOS 5100 , particularly with the paediatric sensor , were significantly higher than the TOI values obtained from the NIRO 300 ( P INVOS and NIRO oximeter was poor . CONCLUSION The large range and the poor agreement of cerebral oxygenation values between the two oximeters makes it difficult to define a normal value . Cerebral oxygenation readings by these monitors , based on one single point measurement during anaesthesia , should be viewed with caution . Actually , there may be little indication for routine use of such monitoring during general anaesthesia",
"Persistent patency of the ductus arteriosus in the preterm infant is associated with numerous morbidities , including higher rates of bronchopulmonary dysplasia and increased mortality . These strong associations have led to widespread use of cyclooxygenase inhibitors and surgical ligation to achieve ductal closure in the expectation that closing the ductus will reduce these complications . Each of these interventions has its own associated adverse effects . Neither individual r and omised controlled trials nor meta-analyses of those trials have been able to demonstrate long-term benefits of these treatments despite their efficacy in inducing ductal closure and reducing the need for ductal ligation . Despite the potential shortcomings of those trials , they provide substantial cumulative evidence that early , routine treatment to close a persistently patent ductus arteriosus in preterm infants does not improve outcomes and should therefore be ab and oned . Future trials of these interventions for patent ductus management should address different questions . Persistence of ductal patency should be considered a sign of rather than a direct cause of the several morbidities with which it is clearly associated . Practitioners should tolerate ductal patency and learn to manage its causes and consequences rather than focusing on achievement of ductal closure",
"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"
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This article proposes a number of recommendations for the treatment of generalized social phobia , based on a systematic literature review and meta- analysis . An optimal treatment regimen would include a combination of medication and psychotherapy , along with an assertive clinical management program . For medications , selective serotonin reuptake inhibitors and dual serotonin-norepinephrine reuptake inhibitors are first-line choices based on their efficacy and tolerability profiles . The nonselective monoamine oxidase inhibitor , phenelzine , may be more potent than these two drug classes , but because of its food and drug interaction liabilities , its use should be restricted to patients not responding to selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors . There are other medication classes with demonstrated efficacy in social phobia ( benzodiazepines , antipsychotics , alpha-2-delta lig and s ) , but due to limited published clinical trial data and the potential for dependence and withdrawal issues with benzodiazepines , it is unclear how best to incorporate these drugs into treatment regimens . There are very few clinical trials on the use of combined medications . Cognitive behavior therapy appears to be more effective than other evidence -based psychological techniques , and its effects appear to be more enduring than those of pharmacotherapy . There is some evidence , albeit limited to certain drug classes , that the combination of medication and cognitive behavior therapy may be more effective than either strategy used alone . Generalized social phobia is a chronic disorder , and many patients will require long-term support and treatment
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"Sixty patients meeting Diagnostic and Statistical Manual of Mental Disorders ( 4th ed . : American Psychiatric Association , 1994 ) criteria for generalized social phobia were assigned to cognitive therapy ( CT ) , fluoxetine plus self-exposure ( FLU + SE ) , or placebo plus self-exposure ( PLA + SE ) . At posttreatment ( 16 weeks ) , the medication blind was broken . CT and FLU + SE patients then entered a 3-month booster phase . Assessment s were at pretreatment , midtreatment , posttreatment , end of booster phase , and 12-month follow-up . Significant improvements were observed on most measures in all 3 treatments . On measures of social phobia , CT was superior to FLU + SE and PLA + SE at midtreatment and at posttreatment . FLU + SE and PLA + SE did not differ . CT remained superior to FLU + SE at the end of the booster period and at 12-month follow-up . On general mood measures , there were few differences between the",
"BACKGROUND This double-blind , placebo-controlled , flexible-dose study was conducted to investigate the efficacy and tolerability of the controlled-release ( CR ) formulation of paroxetine in adults with social anxiety disorder . METHOD Out patients with a primary diagnosis of social anxiety disorder according to DSM-IV criteria entered a 1-week , single-blind , placebo run-in period . Eligible patients were r and omly assigned to receive paroxetine CR ( flexible dose of 12.5 - 37.5 mg/day ) or placebo for 12 weeks of treatment . The primary efficacy measures were the change from baseline in Liebowitz Social Anxiety Scale ( LSAS ) score and the proportion of responders based on Clinical Global Impressions (CGI)-Global Improvement scale score . Data were gathered from September 2001 to July 2002 . RESULTS The intent-to-treat population consisted of 186 patients r and omly assigned to paroxetine CR and 184 patients r and omly assigned to placebo . Statistically significant differences in favor of paroxetine CR compared with placebo were observed in the change from baseline to week 12 last-observation-carried-forward ( LOCF ) data set in LSAS total score ( difference = -13.33 , 95 % confidence interval [ CI ] = -18.25 to -8.41 , p CGI-Global Improvement responder analysis , 57.0 % of patients treated with paroxetine CR achieved response ( very much improved or much improved ) , compared with 30.4 % of patients treated with placebo at week 12 LOCF ( odds ratio = 3.12 , 95 % CI = 2.01 to 4.83 , p Dropout rates due to adverse events were low and comparable in both treatment groups . CONCLUSION Paroxetine CR effectively treated the symptoms associated with social anxiety disorder and was well tolerated , with few patients stopping treatment due to adverse events . This favorable tolerability profile may enable more patients to experience the benefits of effective therapy",
"Allgul and er C. Paroxetine in social anxiety disorder : a r and omized placebo‐controlled study . Acta Psychiatr Sc and 1999 : 100 : 193–198 . © Munksgaard 1999",
"CONTEXT The generalized type of social phobia ( social anxiety disorder ) is a severe and often disabling form of social anxiety that affects approximately 5 % of the general population . Earlier research has shown monoamine oxidase inhibitors or benzodiazepines to be effective in treating this condition , but neither has achieved widespread use . OBJECTIVE To compare the efficacy of paroxetine , a selective serotonin reuptake inhibitor , with placebo in adults with generalized social phobia . DESIGN Twelve-week , multicenter , r and omized , double-blind trial . SETTING Thirteen centers across the United States and 1 in Canada . PARTICIPANTS Between April 13 , 1995 , and February 28 , 1996 , 187 persons meeting Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria for generalized social phobia were r and omized ( and 183 returned for at least 1 efficacy assessment ) to treatment . INTERVENTION After a 1-week , single-blind , placebo , run-in period , patients received a double-blind , 11-week course of either paroxetine or matching-image placebo . The initial daily dosage of paroxetine ( or placebo ) was 20 mg with increases of 10 mg/d weekly ( flexible dosing to a maximum of 50 mg/d ) permitted after the second week of treatment . MAIN OUTCOME MEASURES Number of responders based on the Clinical Global Impression Global Improvement Item ( \" much improved \" or \" very much improved \" ) ; mean change from baseline on the Liebowitz Social Anxiety Scale total score . RESULTS Fifty ( 55.0 % ) of 91 persons taking paroxetine and 22 ( 23.9 % ) of 92 persons taking placebo were much improved or very much improved at the end of treatment ( odds ratio [ OR ] , 3.88 ; 95 % confidence interval [ CI ] , 2.81 - 5.36 ) . Mean Liebowitz Social Anxiety Scale total scores were reduced by 39.1 % ( the mean baseline score of 78.0 declined by a mean of 30.5 points at follow-up ) in the paroxetine group compared with 17.4 % ( the mean baseline score of 83.5 declined 14.5 points at follow-up ) in the placebo group , a difference of 21.7 % ( 95 % CI , 8.7%-34.7 % ) favoring paroxetine . CONCLUSIONS Paroxetine is an effective treatment for patients with generalized social phobia . Short-term ( ie , 11-week ) treatment results in substantial and clinical ly meaningful reductions in symptoms and disability . Future research should test whether these may be further reduced by extended treatment or supplementation with specific educational-cognitive-behavioral techniques",
"BACKGROUND Evidence indicates that venlafaxine hydrochloride extended release ( ER ) effectively ameliorates anxiety symptoms . OBJECTIVES To evaluate the efficacy , safety , and tolerability of flexible-dose venlafaxine ER compared with placebo in the short-term treatment of generalized social anxiety disorder and , secondarily , to compare paroxetine with venlafaxine ER and paroxetine with placebo . DESIGN Adult out patients with DSM-IV generalized social anxiety disorder for 6 months or longer were r and omly assigned to receive venlafaxine hydrochloride ER ( 75 - 225 mg/d ) , paroxetine ( 20 - 50 mg/d ) , or placebo for 12 weeks or less at 26 centers in the United States . The primary outcome measure was the total Liebowitz Social Anxiety Scale score . Secondary measures included response ( Clinical Global Impression-Improvement score , 1 or 2 ) rates and Clinical Global Impression-Severity of Illness and Social Phobia Inventory scores . RESULTS Of 440 patients treated , 413 ( 93.9 % ) were included in the last-observation-carried-forward efficacy analysis ; of the 429 patients in the safety population , 318 ( 74.1 % ) completed the study . Mean daily doses were 201.7 mg ( SD , 38.1 mg ) of venlafaxine hydrochloride ER and 46.0 mg ( SD , 7.9 mg ) of paroxetine . Venlafaxine ER treatment was significantly superior to placebo at weeks 1 through 12 on the Liebowitz Social Anxiety Scale and Social Phobia Inventory and at week 2 and weeks 6 through 12 for Clinical Global Impression-Severity of Illness and responder status , and was significantly superior to paroxetine treatment at weeks 1 and 2 for the Social Phobia Inventory ( P Paroxetine treatment was significantly superior to placebo at weeks 3 through 12 on the Liebowitz Social Anxiety Scale , the Clinical Global Impression-Severity of Illness scale , and the Social Phobia Inventory , and at weeks 4 through 12 for response ( P response rates were significantly greater for the venlafaxine ER and paroxetine groups ( 58.6 % and 62.5 % , respectively ) vs the placebo group ( 36.1 % ) ( P Venlafaxine ER is effective in the short-term treatment of generalized social anxiety disorder , with efficacy and tolerability comparable to paroxetine",
"Background and Aims Cognitive behavioral group therapy ( CBGT ) is an effective , well-established , but not widely available treatment for social anxiety disorder ( SAD ) . Internet-based cognitive behavior therapy ( ICBT ) has the potential to increase availability and facilitate dissemination of therapeutic services for SAD . However , ICBT for SAD has not been directly compared with in-person treatments such as CBGT and few studies investigating ICBT have been conducted in clinical setting s. Our aim was to investigate if ICBT is at least as effective as CBGT for SAD when treatments are delivered in a psychiatric setting . Methods We conducted a r and omized controlled non-inferiority trial with allocation to ICBT ( n = 64 ) or CBGT ( n = 62 ) with blinded assessment immediately following treatment and six months post-treatment . Participants were 126 individuals with SAD who received CBGT or ICBT for a duration of 15 weeks . The Liebowitz Social Anxiety Scale ( LSAS ) was the main outcome measure . The following non-inferiority margin was set : following treatment , the lower bound of the 95 % confidence interval ( CI ) of the mean difference between groups should be less than 10 LSAS-points . Results Both groups made large improvements . At follow-up , 41 ( 64 % ) participants in the ICBT group were classified as responders ( 95 % CI , 52%–76 % ) . In the CBGT group , 28 participants ( 45 % ) responded to the treatment ( 95 % CI , 33%–58 % ) . At post-treatment and follow-up respectively , the 95 % CI of the LSAS mean difference was 0.68–17.66 ( Cohen ’s d between group = 0.41 ) and −2.51–15.69 ( Cohen ’s d between group = 0.36 ) favoring ICBT , which was well within the non-inferiority margin . Mixed effects models analyses showed no significant interaction effect for LSAS , indicating similar improvement across treatments ( F = 1.58 ; df = 2 , 219 ; p = .21 ) . Conclusions ICBT delivered in a psychiatric setting can be as effective as CBGT in the treatment of SAD and could be used to increase availability to CBT . Trial Registration Clinical Trials.gov",
"Selective serotonin reuptake inhibitors are the pharmacological treatment of choice for the treatment of social anxiety disorder ( SAD ) . The efficacy and tolerability of fixed doses of escitalopram were compared to those of placebo in the long‐term treatment of generalised SAD , using paroxetine as an active reference . Patients with a DSM‐IV diagnosis of SAD between 18–65 years of age were r and omised to 24 weeks of double‐blind treatment with placebo ( n = 166 ) , 5 mg escitalopram ( n = 167 ) , 10 mg escitalopram ( n = 167 ) , 20 mg escitalopram ( n = 170 ) , or 20 mg paroxetine ( n = 169 ) . Based on the primary efficacy parameter , Liebowitz Social Anxiety Scale ( LSAS ) total score at Week 12 ( LOCF ) , a significantly superior therapeutic effect compared to placebo was seen for 5 and 20 mg escitalopram and for all doses for the OC analyses . Further improvement in LSAS scores was seen at Week 24 ( OC and LOCF ) , with significant superiority over placebo for all doses of escitalopram , and 20 mg escitalopram was significantly superior to 20 mg paroxetine . Response to treatment ( assessed by a Clinical Global Impression‐Improvement score ≤2 ) was significantly higher for all active treatments than for placebo at Week 12 . Clinical relevance was supported by a significant decrease in all the Sheehan disability scores , and the good tolerability of escitalopram treatment . It is concluded that doses of 5–20 mg escitalopram are effective and well tolerated in the short‐ and long‐term treatment of generalised SAD . Depression and Anxiety 00:000–000 , 2004 . © 2004 Wiley‐Liss ,",
"Background : Generalized social anxiety disorder is a highly prevalent anxiety disorder with deleterious effects on social and family relationships , as well as work performance . We report the results of a multicenter , r and omized , placebo-controlled trial comparing the efficacy , safety , and tolerability of fluvoxamine controlled release ( CR ) to placebo in patients with generalized social anxiety disorder . Methods : A total of 279 adult patients meeting all inclusion /exclusion criteria was recruited at 23 United States sites and r and omly assigned to receive either fluvoxamine CR ( 100 - 200 mg/d ) or placebo for 12 weeks . The dose could be increased , based on efficacy and tolerability , in increments of 50 mg/d at weekly intervals . The dosage remained constant during weeks 6 to 12 . Results : Treatment with fluvoxamine CR result ed in statistically and clinical ly significant improvements in symptoms associated with generalized social anxiety disorder as early as week 4 on the Liebowitz Social Anxiety Scale and the Clinical Global Impression Scale Global Improvement , and at week 6 on the Sheehan Disability Scale , Clinical Global Impression Scale Severity of Illness and the Patient Global Impression of Improvement Scale . The most frequent adverse events reported by patients on fluvoxamine CR were headache , nausea , somnolence , and insomnia . No weight gain was observed for either treatment group , and at end point , there were no differences between treatments on overall sexual function , as measured by the Arizona Sexual Experience Scale . Conclusions : Both physician and patient-rated scales indicate that fluvoxamine CR is effective and safe for the treatment of generalized social anxiety disorder",
"Although the monoamine oxidase inhibitor phenelzine has proven efficacious in social phobia , the risk of hypertensive crises has reduced its acceptability . The reversible monoamine oxidase inhibitor moclobemide has less potential for such reactions , but its efficacy in this disorder remains unproven . A double-blind , placebo-controlled study was undertaken to assess the efficacy and safety of fixed doses of moclobemide . After a 1-week placebo run-in , subjects with social phobia were r and omly assigned to placebo or one of five doses ( 75 mg , 150 mg , 300 mg , 600 mg , or 900 mg daily ) of moclobemide for 12 weeks . Although a trend toward greater efficacy of higher doses of moclobemide was observed at 8 weeks , no differences in response to various doses of the drug and placebo were observed at 12 weeks . At 12 weeks , 35 % of subjects on 900 mg of moclobemide and 33 % of those on placebo were at least much improved . Moclobemide was well tolerated , insomnia being the only dose-related adverse event observed with the drug . In this dose-response trial , moclobemide did not demonstrate efficacy at 12 weeks . Some other controlled studies have found moclobemide and brofaromine , another reversible monoamine oxidase inhibitor , efficacious in social phobia . Possible reasons for inconsistent findings are discussed",
"BACKGROUND Generalized social phobia is common , persistent , and disabling and is often treated with selective serotonin reuptake inhibitor drugs or cognitive behavioral therapy . OBJECTIVE We compared fluoxetine ( FLU ) , comprehensive cognitive behavioral group therapy ( CCBT ) , placebo ( PBO ) , and the combinations of CCBT/FLU and CCBT/PBO . DESIGN R and omized , double-blind , placebo-controlled trial . SETTING Two academic outpatient psychiatric centers . PATIENTS Subjects meeting a primary diagnosis of generalized social phobia were recruited via advertisement . Seven hundred twenty-two were screened , and 295 were r and omized and available for inclusion in an intention-to-treat efficacy analysis ; 156 ( 52.9 % ) were male , 226 ( 76.3 % ) were white , and mean age was 37.1 years . INTERVENTIONS Treatment lasted for 14 weeks . Fluoxetine and PBO were administered at doses from 10 mg/d to 60 mg/d ( or equivalent ) . Group comprehensive cognitive behavioral therapy was administered weekly for 14 sessions . MAIN OUTCOME MEASURES An independent blinded evaluator assessed response with the Brief Social Phobia Scale and Clinical Global Impressions scales as primary outcomes . A videotaped behavioral assessment served as a secondary outcome , using the Subjective Units of Distress Scale . Adverse effects were measured by self-rating . Each treatment was compared by means of chi2 tests and piecewise linear mixed-effects models . RESULTS Clinical Global Impressions scales response rates in the intention-to-treat sample were 29 ( 50.9 % ) ( FLU ) , 31 ( 51.7 % ) ( CCBT ) , 32 ( 54.2 % ) ( CCBT/FLU ) , 30 ( 50.8 % ) ( CCBT/PBO ) , and 19 ( 31.7 % ) ( PBO ) , with all treatments being significantly better than PBO . On the Brief Social Phobia Scale , all active treatments were superior to PBO . In the linear mixed-effects models analysis , FLU was more effective than CCBT/FLU , CCBT/PBO , and PBO at week 4 ; CCBT was also more effective than CCBT/FLU and CCBT/PBO . By the final visit , all active treatments were superior to PBO but did not differ from each other . Site effects were found for the Subjective Units of Distress Scale assessment , with FLU and CCBT/FLU superior to PBO at Duke University Medical Center , Durham , NC . Treatments were well tolerated . CONCLUSIONS All active treatments were superior to PBO on primary outcomes . Combined treatment did not yield any further advantage . Notwithst and ing the benefits of treatment , many patients remained symptomatic after 14 weeks",
"BACKGROUND Maintenance of treatment effect is important for the choice of treatment for social phobia . AIMS To examine the effect of exposure therapy and sertraline 28 weeks after cessation of medical treatment . METHOD In this study 375 patients with social phobia were r and omised to treatment with sertraline or placebo for 24 weeks , with or without the addition of exposure therapy . Fifty-two weeks after inclusion , 328 patients were evaluated by the same psychometric tests as at baseline and the end of treatment ( 24 weeks ) . RESULTS The exposure therapy group and the placebo group had a further improvement in scores on social phobia during follow-up : mean change in the Clinical Global Impression - Social Phobia overall severity score was 0.45 ( 95 % CI 0.16 - 0.65 , P placebo group . At week 52 the sertraline plus exposure group and the sertraline-alone group had a significant deterioration on the 36-item Short Form Health Survey compared with exposure alone . CONCLUSIONS Exposure therapy alone yielded a further improvement during follow-up , whereas exposure therapy combined with sertraline and sertraline alone showed a tendency towards deterioration after the completion of treatment",
" Sixty-five patients with social phobia were treated in a study that compared a cognitive-behavioral group treatment program with pharmacotherapy with alprazolam , phenelzine sulfate , or pill-placebo plus instructions for self-directed exposure to phobic stimuli . Statistically significant repeated- measures effects were shown on all measures , indicating that the treatments studied were associated with substantial improvements in patients with severe and chronic social phobia . Patients who were treated with phenelzine were rated by clinicians as more improved on a measure of work and social disability than patients who were treated with alprazolam or placebo ( patients in the cognitive-behavior therapy group were not rated on this measure ) . Subjects showed positive cognitive changes from before to after treatment , and there were no differences between treatment groups on the cognitive measure . We discuss the implication s of these findings within the context of demographic and clinical predictors of response",
"BACKGROUND Moclobemide , a reversible inhibitor of monoamine oxidase A , previously has been reported to have efficacy in the treatment of social phobia . METHOD Seventy-seven non-responders to one week of single-blind placebo were r and omly assigned to moclobemide or placebo for eight weeks of double-blind treatment . Outcome was assessed by independent evaluator , treating psychiatrist and self-ratings . After eight weeks , patients who were at least minimally improved continued treatment for a further eight weeks . RESULTS Intention-to-treat sample response rates at week 8 were 7/40 ( 17.5 % ) for the moclobemide group and 5/37 ( 13.5 % ) for placebo ( NS ) . Moclobemide was significantly superior to placebo on 2 of 10 primary outcome measures . Moclobemide was well tolerated . CONCLUSIONS Moclobemide may have efficacy in the treatment of social phobia , but absence of significant differences on most primary outcome measures and small effect sizes for all outcome measures suggest that the magnitude of its clinical effect is small",
"The past decade has brought major new developments in the psychopharmacologic management of generalized anxiety disorder and social phobia . We examined medication-prescribing patterns for the treatment of these anxiety disorders for 12 years to assess changes in patients ' anti-anxiety psychotropic medication usage during that period of evolving practice guidelines . We examined psychotropic medication use in 305 patients with generalized anxiety disorder and 232 with social phobia enrolled in the Harvard/Brown Anxiety Disorders Research Project ( HARP ) , a prospect i ve , longitudinal study of anxiety disorders . Psychotropic treatment patterns seem to have remained relatively stable over 12 years with benzodiazepines the medications most commonly used for both generalized anxiety disorder and social phobia . Comparatively , selective serotonin reuptake inhibitor ( SSRI ) and venlafaxine usage as st and -alone medications for these disorders remained low throughout the follow-up period . At the 12-year follow-up , 24 % of patients with generalized anxiety disorder and 30 % of patients with social phobia were utilizing neither an SSRI/selective norepinephrine reuptake inhibitor ( SNRI ) nor a benzodiazepine . Treatment recommendations for use of SSRIs and venlafaxine in the management of generalized anxiety disorder and social phobia initially promulgated in 1998 had a modest impact on changes in psychopharmacologic practice 4 - 5 years later . Difficulties in the implementation of treatment guidelines are discussed",
"Clonazepam and placebo were administered in a double-blind pilot study to 75 out patients with social phobia . The mean maximum dose of clonazepam was 2.4 mg/day at endpoint ( range , 0.5 to 3 mg ) . Treatment was continued for up to 10 weeks . The results of an intent-to-treat analysis indicated superior effects of clonazepam on most measures . Response rates for clonazepam and placebo were 78.3 and 20.0 % . Drug effects were apparent on performance and generalized social anxiety , on fear and phobic avoidance , on interpersonal sensitivity , on fears of negative evaluation , and on disability measures . Significant differences were evident by week 1 , 2 , or 6 , depending upon the rating scale used . Clonazepam was well tolerated in general , although unsteadiness and dizziness were more severe and persistent than was the case for placebo subjects",
"Eighty patients meeting DSM-IV criteria for social phobia were r and omly assigned to 10 weeks of residential cognitive therapy ( RCT ) or residential interpersonal therapy ( RIPT ) . Subjects were assessed at pretreatment , midtreatment , posttreatment , and 1 year after end of treatment . The patients reported chronic , highly comorbid social phobia . Most had tried other treatments without success . Existing individual treatment protocol s for cognitive therapy and interpersonal therapy were extensively modified for an integrated group , individual , and residential format . The RCT and RIPT patients improved significantly on the primary outcome measures from pre- to posttreatment . No significant differences were observed between treatments . Patients also completed three weekly secondary outcome measures ; on one , social role security , RCT was superior to RIPT . The entire sample reported continued improvement from posttreatment to 1-year follow-up , indicating that improvements were robust . RCT in the present trial was associated with less improvement compared to individual CT in other recent trials",
"BACKGROUND Generalized social anxiety disorder is an early onset , highly chronic , frequently disabling disorder with a lifetime prevalence of approximately 13 % . The goal of the current study was to evaluate the efficacy and tolerability of sertraline for the treatment of severe generalized social anxiety disorder in adults . METHOD After a 1-week single-blind placebo lead-in period , patients with DSM-IV generalized social phobia were r and omly assigned to 12 weeks of double-blind treatment with flexible doses of sertraline ( 50 - 200 mg/day ) or placebo . Primary efficacy outcomes were the mean change in the Liebowitz Social Anxiety Scale ( LSAS ) total score and the responder rate for the Clinical Global Impressions-Improvement scale ( CGI-I ) , defined as a CGI-I score 211 patients were r and omly assigned to sertraline ( intent-to-treat [ ITT ] sample , 205 ) , and 204 patients , to placebo ( ITT sample , 196 ) . At week 12 , sertraline produced a significantly greater reduction in LSAS total score compared with placebo ( mean last-observation-carried-forward [ LOCF ] change from baseline : -31.0 vs. -21.7 ; p = .001 ) and a greater proportion of responders ( CGI-I score Sertraline was well tolerated , with 7.6 % of patients discontinuing due to adverse events versus 2.9 % of placebo-treated patients . CONCLUSION The results of the current study confirm the efficacy of sertraline in the treatment of severe social anxiety disorder",
"This study is aim ed at investigating the efficacy and tolerability of mirtazapine in a generalized social anxiety disorder . Sixty patients with generalized social anxiety disorder were r and omly allocated to receive mirtazapine ( 30–45 mg/day ) ( n=30 ) or placebo ( n=30 ) for 12 weeks in a double-blind study design . Primary efficacy was assessed by the Liebowitz Social Anxiety Scale ( LSAS ) and response to treatment was defined as a reduction of 40 % on the LSAS and an improvement on the Clinical Global Impression scale of ‘ much or very much improved ’ . An intent-to-treat analysis showed no difference between mirtazapine and placebo on the absolute LSAS scores with a mean decrease of 13.5±16.9 and 11.2±17.8 respectively , and on the number of responders , 13 and 13 % , respectively . In conclusion , mirtazapine ( 30–45 mg/day ) failed to be effective in the generalized social anxiety disorder ",
"The aim of the study was to assess the 6-months treatment efficacy and 24-month follow up of three different therapeutic programs ( A. moclobemide and supportive guidance , B. group cognitive-behavioral therapy and pill placebo , and C. combination of moclobemide and group cognitive-behavioral therapy ) in patients with a generalized form of social phobia . Eighty one patients ( 38 males and 43 females ) were r and omly assigned to three different therapeutic programs . Patients were regularly assessed on a monthly basis by an independent rater on the LSAS ( Liebowitz Social Anxiety scale ) , CGI ( Clinical Global Impression ) for severity and change and BAI ( Beck Anxiety Inventory ) . Altogether , sixty-six patients completed the six month treatment period and 15 patients dropped out . All therapeutic groups showed significant improvement . A combination of CBT and pharmacotherapy yielded the most rapid effect . Moclobemide was superior for the reduction of the subjective general anxiety ( BAI ) during the first 3 months of treatment , but its influence on avoidant behavior ( LSAS avoidance subscale ) was less pronounced . Conversely , CBT was the best choice for reduction of avoidant behavior while a reduction of subjective general anxiety appeared later than in moclobemide . After 6 months of treatment there were best results reached in groups treated with CBT and there was no advantage of the combined treatment . The relapse rate during the 24-month follow up was significantly lower in the group treated with CBT in comparison with the group A. formerly treated with moclobemide alone",
"OBJECTIVE The purpose of this study was to determine the efficacy of fluvoxamine for the treatment of social phobia ( social anxiety disorder ) . METHOD In a 12-week multicenter , double-blind , r and omized , placebo-controlled trial , 92 patients with social phobia were treated with the selective serotonin reuptake inhibitor fluvoxamine ; 91.3 % of the patients had the generalized subtype of the disorder . The primary criterion for response was a rating of \" much improved \" or \" very much improved \" on the Clinical Global Impression of Improvement scale . Secondary response criteria were changes on three specialized rating scales for social phobia symptoms : the Brief Social Phobia Scale , the Social Phobia Inventory , and the Liebowitz Social Anxiety Scale . Psychosocial impairment was assessed in three domains ( disruption of work , social life , and home/family life ) by using the Sheehan Disability Scale . RESULTS The mean daily dose of fluvoxamine was 202 mg ( SD = 86 ) . At study end or with the last observation carried forward , within the evaluable subjects ( N = 86 ) there was a significantly higher proportion of responders in the fluvoxamine group ( 42.9 % , N = 18 ) than in the placebo group ( 22.7 % , N = 10 ) . Similarly , fluvoxamine was superior to placebo on all social phobia rating scales at week 8 and beyond . Fluvoxamine also result ed in significantly greater decreases in measures of psychosocial disability than did placebo . Overall , fluvoxamine was well tolerated and safe . CONCLUSIONS These findings indicate that fluvoxamine is efficacious in the pharmacologic management of serious forms of social phobia",
"CONTEXT Cognitive therapy ( CT ) focuses on the modification of biased information processing and dysfunctional beliefs of social anxiety disorder ( SAD ) . Interpersonal psychotherapy ( IPT ) aims to change problematic interpersonal behavior patterns that may have an important role in the maintenance of SAD . No direct comparisons of the treatments for SAD in an outpatient setting exist . OBJECTIVE To compare the efficacy of CT , IPT , and a waiting-list control ( WLC ) condition . DESIGN R and omized controlled trial . SETTING Two academic outpatient treatment sites . Patients Of 254 potential participants screened , 117 had a primary diagnosis of SAD and were eligible for r and omization ; 106 participants completed the treatment or waiting phase . INTERVENTIONS Treatment comprised 16 individual sessions of either CT or IPT and 1 booster session . Twenty weeks after r and omization , posttreatment assessment was conducted and participants in the WLC received 1 of the treatments . MAIN OUTCOME MEASURES The primary outcome was treatment response on the Clinical Global Impression Improvement Scale as assessed by independent masked evaluators . The secondary outcome measures were independent assessor ratings using the Liebowitz Social Anxiety Scale , the Hamilton Rating Scale for Depression , and patient self-ratings of SAD symptoms . RESULTS At the posttreatment assessment , response rates were 65.8 % for CT , 42.1 % for IPT , and 7.3 % for WLC . Regarding response rates and Liebowitz Social Anxiety Scale scores , CT performed significantly better than did IPT , and both treatments were superior to WLC . At 1-year follow-up , the differences between CT and IPT were largely maintained , with significantly higher response rates in the CT vs the IPT group ( 68.4 % vs 31.6 % ) and better outcomes on the Liebowitz Social Anxiety Scale . No significant treatment × site interactions were noted . CONCLUSIONS Cognitive therapy and IPT led to considerable improvements that were maintained 1 year after treatment ; CT was more efficacious than was IPT in reducing social phobia symptoms ",
"While serotonergic antidepressants are now established as first-line pharamcotherapy for generalized social anxiety disorder ( SAD ) , other agents with different mechanisms have shown promise in treating SAD . The aim of this pilot study is to examine the efficacy and safety of levetiracetam ( LEV ) , an anticonvulsant with calcium channel modulating properties , in treating SAD . Adult out patients meeting DSM-IV criteria for SAD were r and omly assigned ( 2:1 ) to double-blind treatment with either LEV ( 500 - 3000mg/day ) or placebo ( PBO ) for 7 weeks . The primary outcome measures were the change from baseline in the Brief Social Phobia Scale ( BSPS ) and response using the Clinical Global Impression of Improvement scale ( CGI-I ) . The mean ( SD ) BSPS scores at baseline and endpoint were 45.4 ( 9.7 ) and 31.2 ( 19.7 ) for LEV ( n 9 ) , compared to 43.5 ( 8.4 ) and 37.8 ( 19.9 ) for PBO ( n 7 ) ( ITT ; ns ) . Rates of response were 22 % for LEV and 14 % for PBO using the CGI-I. Using a BSPS response criterion ( > 30 % reduction ) , response rates were 44 % for LEV and 14 % for PBO . The effect sizes of LEV relative to PBO were 0.33 for the BSPS and 0.50 for the LSAS . In summary , the results of this study , while negative on the pre-defined measures , suggest promise for LEV as a new treatment of SAD . Further work should be carried out with larger sample sizes and optimal dosing strategies of the drug",
"Previous studies have shown selective and non-selective monoamine oxidase inhibitors ( MAOIs ) to be effective in the treatment of social phobia . In this study we investigated the efficacy of selective serotonin reuptake inhibitors ( SSRIs ) in social phobia . Thirty patients with social phobia ( DSM-IIIR ) were treated with the SSRI fluvoxamine ( 150 mg daily ) using a 12-week double-blind placebo controlled design . A substantial improvement was observed in seven ( 46 % ) patients on fluvoxamine and in one ( 7 % ) on placebo . Statistically significant effects were seen on measures of social anxiety and general ( or anticipatory ) anxiety in patients treated with fluvoxamine compared with placebo . The level of phobic avoidance decreased also but the difference at endpoint between fluvoxamine and placebo failed to reach statistical significance . It is concluded that treatment with the SSRI fluvoxamine has beneficial effects in patients suffering from social phobia , suggesting that serotonergic mechanisms might be implicated in social anxiety",
"OBJECTIVE The authors evaluated the efficacy , safety , and tolerability of sertraline , a selective serotonin reuptake inhibitor , in the treatment of generalized social phobia . METHOD Adult out patients with generalized social phobia ( N=204 ) from 10 Canadian centers were r and omly assigned to receive sertraline or placebo in a 2:1 ratio for a 20-week double-blind study following a 1-week , single-blind , placebo run-in . The initial dose of sertraline was 50 mg/day with increases of 50 mg/day every 3 weeks permitted after the fourth week of treatment ( dosing was flexible up to a maximum of 200 mg/day ) . Primary efficacy assessment s were the percentage of patients rated much or very much improved on the Clinical Global Impression ( CGI ) improvement item and the mean changes from baseline to study endpoint in total score on the social phobia subscale of the Marks Fear Question naire and total score on the Brief Social Phobia Scale . RESULTS In intent-to-treat endpoint analyses of 203 of the patients , significantly more of the 134 patients given sertraline ( N=71 [ 53 % ] ) than of the 69 patients receiving placebo ( N=20 [ 29 % ] ) were considered responders according to their CGI improvement scores at the end of treatment . The mean reductions in the social phobia subscale of the Marks Fear Question naire and in the total score on the Brief Social Phobia Scale were 32.6 % and 34.3 % in the sertraline group and 10.8 % and 18.6 % in the placebo group , respectively . Analysis of covariance showed superiority of sertraline over placebo on all primary and secondary efficacy measures . Sertraline was well tolerated : 103 ( 76 % ) of the 135 sertraline-treated patients and 54 ( 78 % ) of the 69 placebo-treated patients completed the study . CONCLUSIONS Sertraline is an effective treatment for patients with generalized social phobia",
"Seventy‐seven patients with a primary diagnosis of social phobia ( DSM‐III‐R ) were r and omized to treatment with the reversible and selective monoamine oxidase type A inhibitor brofaromine ( n= 37 ) or placebo ( n= 40 ) for 12 weeks in a double‐blind trial . A fixed dose of 150 mg/day or a matching placebo was given after a 2‐week dose titration phase . Patients with additional diagnoses of simple phobia , generalized anxiety disorder , dysthymia or major depressive disorder currently in remission were accepted . Patients with other Axis I mental disorders were excluded . In the brofaromine group , 78 % of the patients scored much or very much improved on the Clinical Global Impression scale compared with 23 % in the placebo group . The anxiety and avoidance scores on the Liebowitz Social Anxiety Scale ( LSAS ) were significantly reduced in favor of brofaromine . The clinical effects were not significantly correlated with the plasma concentration of brofaromine . After 12 weeks the brofaromine group scored significantly Jower than the placebo group on a core depression part of the Montgomery‐Åsberg Depressid Rating Scale . After 12 weeks of treatment the brofaromine group had significantly higher total scores on the LSAS than an age‐ and gender‐matched group of healthy controls . The brofaromine group improved further during 9‐month follow‐up treatment period , whereas 60 % of the placebo responders who continued long‐term treatment relapsed . The most common side effects in the brofaromine group were sleep disturbances , dry mouth and nausea",
"A r and omized , double-blind , placebo-controlled , parallel-group study was conducted to evaluate the efficacy and safety of gabapentin in relieving the symptoms of social phobia . Sixty-nine patients were r and omly assigned to receive double-blind treatment with either gabapentin ( dosed flexibly between 900 and 3,600 mg daily in three divided doses ) or placebo for 14 weeks . A significant reduction ( p symptoms of social phobia was observed among patients on gabapentin compared with those on placebo as evaluated by clinician- and patient-rated scales . Results were similar for the intent-to-treat and week-2 completer population s. Adverse events were consistent with the known side effect profile of gabapentin . Dizziness ( p = 0.05 ) , dry mouth ( p = 0.05 ) , somnolence , nausea , flatulence , and decreased libido occurred at a higher frequency among patients receiving gabapentin than among those receiving placebo . No serious adverse events or deaths were reported . On the basis of these limited data , it seems that gabapentin offers a favorable risk-benefit ratio for the treatment of patients with social phobia . Further studies are required to confirm this effect and to determine whether a dose-response relationship exists",
"BACKGROUND The efficacy of selective serotonin reuptake inhibitors in the acute treatment of social anxiety disorder ( social phobia ) is well established . OBJECTIVE To evaluate whether the efficacy of paroxetine hydrochloride in this disorder is maintained in the long term . METHODS This was a placebo-controlled multicenter study comprising a single-blind acute treatment phase ( 12 weeks ) and a r and omized , double-blind maintenance treatment phase ( 24 weeks ) for patients who had responded to paroxetine during the acute phase . Four hundred thirty-seven adult patients with social anxiety disorder ( according to Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , criteria , code 300.23 ) entered the acute phase , and 323 continued into the maintenance phase ( 162 paroxetine and 161 placebo ) . The principal outcome measure was the proportion of patients relapsing during the maintenance phase . RESULTS Two hundred fifty-seven patients completed the study ( 136 paroxetine-treated and 121 placebo-treated patients ) . Significantly fewer patients relapsed in the paroxetine group than in the placebo group ( 14 % vs 39 % ; odds ratio , 0.24 ; 95 % confidence interval , 0.14 - 0.43 ; P paroxetine group showed improvement as shown on the Clinical Global Impression global improvement rating compared with the placebo group ( 78 % vs 51 % ; odds ratio , 3.66 ; 95 % confidence interval , 2.22 - 6.04 ; P placebo , paroxetine treatment significantly ( P symptoms of social anxiety as shown on the Liebowitz Social Anxiety Scale , Social Phobia Inventory , Sheehan Disability Scale , Symptom Checklist-90 score , and EuroQol visual analogue scale , indicating decreased disability and increased well-being . Paroxetine was well tolerated . CONCLUSION Paroxetine is an effective long-term treatment for social anxiety disorder",
"We conducted an 11-week forced-escalation open-label study of paroxetine in the treatment of 36 patients with generalized social phobia . At the mean dosage of 47.9 + /- 6.2 mg/day , 23 of 30 completers ( 77 % ) were deemed responders on the basis of a clinician rating of either \" very much improved \" or \" much improved \" on the Clinical Global Impressions scale . Duke Social Phobia Scale ratings declined from 35.5 + /- 13.1 at baseline to 19.7 + /- 17.4 at week 11 ( p Liebowitz Social Anxiety Scale ratings declined from 75.1 + /- 25.4 at baseline to 37.2 + /- 32.5 at week 11 ( p paroxetine ( with no dosage change ) or placebo ( after a taper period ) on a double-blind basis . To the best of our knowledge , this is the first controlled medication-discontinuation study in social phobia . One of eight patients r and omized to continue paroxetine relapsed versus five of eight patients r and omized to placebo . These findings call for a double-blind , placebo-controlled treatment study of paroxetine in generalized social phobia . They also suggest that relapse rates are high if medication is discontinued early and that further study is needed to determine ( 1 ) the optimal duration of maintenance pharmacotherapy for social phobia and ( 2 ) if specific psychotherapeutic interventions before medication discontinuation may prevent relapse",
"Social anxiety disorder ( SAD ) is one of the most common anxiety disorders . Reports have suggested an effect of the atypical antipsychotic quetiapine in anxiety disorders . Given these considerations , we conducted a controlled trial of quetiapine monotherapy in SAD . Fifteen patients were r and omized to quetiapine ( up to 400 mg/day ) or placebo for 8 weeks . The Brief Social Phobia Scale ( BSPS ) and the Clinical Global Impression of Improvement Scale ( CGI-I ) were the primary outcome measures , while the Social Phobia Inventory ( SPIN ) and the Sheehan Disability Inventory ( SDI ) were secondary measures . There was no significant difference on the BSPS score at endpoint between the quetiapine and placebo groups . There was a significant time effect but not a significant time x treatment group interaction , indicating that both the quetiapine and placebo patients did better over the course of the trial . 20 % of the quetiapine patients had a 50 % or greater drop in BSPS score at the end of the trial compared to baseline , while 0 % had such a drop in the placebo group . There was no significant difference in responders ( CGI-I score of 1 or 2 ) versus non-responder ( CGI-I score of 3 or more ) across the groups . However , 40 % of quetiapine patients and 0 % of the placebo patients showed much or very much improvement on the CGI-I. The Number Needed to Treat ( NNT ) to be a responder on the CGI-I was 3 . Significant time effects were noted for the SPIN and SDI , as well as a significant time x treatment effect in favor of quetiapine on the SPIN . Additionally , quetiapine showed a large effect size on the SPIN",
"BACKGROUND Selective serotonin reuptake inhibitors ( SSRIs ) are the current gold st and ard in the pharmacologic treatment of generalized social phobia . SSRIs are only effective in approximately 50 % of individuals with generalized social phobia and can be associated with significant side effects . Based on the successful use of the anticonvulsants gabapentin and pregabalin in treating generalized social phobia , we conducted an open trial examining the efficacy of the glutamatergic and GABAergic anticonvulsant topiramate in the treatment of generalized social phobia . METHOD Twenty-three adult out patients with DSM-IV social phobia , generalized type , were entered into a 16-week open trial of topiramate , starting at 25 mg/day , and gradually titrated up to a maximum dose of 400 mg/day . RESULTS Twelve of 23 patients completed the trial . In the intent-to-treat ( ITT ) analysis , 11 ( 47.8 % ) of 23 were responders by a Clinical Global Impressions Improvement ( CGI-I ) scale rating of \" much \" or \" very much \" improved . The mean drop in the Liebowitz Social Anxiety Scale ( LSAS ) score for the ITT group was 29.4 % . The change in LSAS score from baseline to endpoint was significant for the ITT group ( F = 3.44 , df = 4,110 ; p = .01 ) . In the completers group , 9 ( 75.0 % ) of 12 were responders by CGI-I at 16 weeks , with a mean drop in LSAS score of 45.1 % . The rate of remission in the ITT sample , using a definition of an LSAS score of remission rate of 26.1 % ( 6/23 ) . CONCLUSION This study suggests that topiramate may be effective in the treatment of generalized social phobia . These results also suggest the possibility that the neurotransmitters glutamate and GABA may be involved in the neurobiology of generalized social phobia",
"The current mainstays of social anxiety disorder pharmacotherapy are serotonergic agents , with less known about the efficacy of more noradrenergic drugs . Atomoxetine ( ATM ) , a highly selective norepinephrine reuptake inhibitor , is currently approved for the treatment of attention-deficit/hyperactivity disorder ( ADHD ) . We describe the first controlled trial of ATM with respect to efficacy and tolerability in adults with the generalized subtype of social anxiety disorder ( GSAD ) without comorbid ADHD . Twenty-seven out patients with clinical ly prevailing diagnoses of GSAD by the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition were r and omized in a 1:1 ratio to 10 weeks of double-blind flexible-dose treatment with either ATM 40 - 100 mg per day ( n = 14 ) or placebo ( n = 13 ) . Primary efficacy outcome was score at end point on the Liebowitz Social Anxiety Scale in the intention-to-treat sample . There were no significant group differences in patients completing the study ( ATM , 79 % ; placebo , 77 % ) . Whereas ATM was well tolerated , there were no significant differences in clinical efficacy between ATM and placebo for GSAD . There were few responders overall ( ATM , 21 % ; placebo , 33 % ) , but proportions were similar in each group ( & khgr;2 [ 1 , 26 ] = 0.47 ; P = 0.67 ) . Analysis of variance with repeated measures on the Liebowitz Social Anxiety Scale was performed to detect any differential change in social anxiety symptoms between groups . A significant time effect was found ( F = 8.71 ; P = 0.007 ) , but the time-by-treatment interaction was nonsignificant ( F = 0.013 ; P = 0.91 ) . Although the small sample size limits confidence in the reported results , the comparable , and low , response rates for ATM and placebo suggest that in the absence of comorbid ADHD , ATM is unlikely to be an effective agent for the treatment of GSAD",
"Mindfulness-based stress reduction ( MBSR ) has been reported to reduce anxiety in a broad range of clinical population s. However , its efficacy in alleviating core symptoms of specific anxiety disorders is not well established . We conducted a r and omized trial to evaluate how well MBSR compared to a first-line psychological intervention for social anxiety disorder ( SAD ) . Fifty-three patients with DSM-IV generalized SAD were r and omized to an 8-week course of MBSR or 12 weekly sessions of cognitive-behavioral group therapy ( CBGT ) . Although patients in both treatment groups improved , patients receiving CBGT had significantly lower scores on clinician- and patient-rated measures of social anxiety . Response and remission rates were also significantly greater with CBGT . Both interventions were comparable in improving mood , functionality and quality of life . The results confirm that CBGT is the treatment of choice of generalized SAD and suggest that MBSR may have some benefit in the treatment of generalized SAD",
"Rationale There is a need for new pharmacological treatments for generalized social anxiety disorder ( GSAD ) , which is a common , often disabling condition . Objective To compare the efficacy and safety over 6 months duration of two dose ranges of venlafaxine extended-release ( ER ) with placebo in patients with GSAD . Method Twenty-eight-week , double-blind , multi-center study in 386 adult out patients with DSM-IV GSAD . Patients were r and omized to placebo , venlafaxine ER fixed low dose ( 75 mg/day ) , or venlafaxine ER flexible higher dose ( 150–225 mg/day ) . Primary efficacy variable was change on the Liebowitz Social Anxiety Scale ( LSAS ) . Secondary efficacy variables included , among others , the proportion of responders on the CGI Global Improvement Item ( score 1 or 2 ) , and the proportion of remitters ( defined as an LSAS score of ≤30 ) . Results Improvement on the LSAS was greater with venlafaxine ER ( at 75 mg/day or 150–225 mg/day ) than placebo , and was sustained throughout the 6-month trial . Of patients receiving venlafaxine ER ( at any dose ) , 58 % responded to treatment compared to 33 % of those receiving placebo ( P ; corresponding remission rates were 31 % and 16 % ( P according to venlafaxine ER dosage . Conclusions Venlafaxine ER was effective in the treatment of GSAD . The comparable efficacy at low and higher doses may indicate that norepinephrine reuptake blockade does not contribute to therapeutic effect in GSAD . This hypothesis should be tested using agents with specific actions on norepinephrine reuptake blockade",
"Abstract : Social phobia is an anxiety disorder characterized by extreme fear and phobic avoidance of social and performance situations and by a relatively poor health-related quality of life . The goal of this study was to compare the efficacy of mirtazapine versus placebo in the treatment of patients with social phobia . In 2004 , we conducted a r and omized , double-blind , placebo-controlled study of mirtazapine in 66 female subjects from the general population meeting the criteria for social phobia . The subjects were r and omly assigned in a 1:1 manner to mirtazapine ( n = 33 ) or placebo ( n = 33 ) . The treatment lasted 10 weeks . Seven patients dropped out . Primary outcome measures were self-reported changes on the Social Phobia Inventory , Liebowitz Social Anxiety Scale , and Health Survey ( SF-36 ) . In comparison with the placebo group and according to the intent-to-treat principle , significant differences on the Social Phobia Inventory and Liebowitz Social Anxiety Scale scales ( all P SF-36 ( all P mirtazapine-treated subjects . All patients tolerated mirtazapine relatively well . Mirtazapine appears to be an effective agent in the treatment of social phobia in women and in the improvement of their health-related quality of life",
"BACKGROUND Both psychodynamic group therapy ( PGT ) and clonazepam are used as treatment strategies in reducing symptoms of generalized social anxiety disorder ( GSAD ) . However , many individuals remain symptomatic after treatment with PGT or clonazepam . METHOD Fifty-eight adult out patients with a diagnosis of GSAD according to DSM-IV were r and omized to 12 weeks PGT plus clonazepam or clonazepam . The Clinical Global Impression-Improvement ( CGI-I ) Scale was the primary efficacy measure . Secondary efficacy measures included the Liebowitz Social Anxiety Scale ( LSAS ) total score , the World Health Organization Instrument to Assess Quality of Life-Brief ( WHOQOL-Bref ) Scale and the Beck Depression Inventory ( BDI ) . RESULTS CGI-I data from 57 patients ( intent-to-treat population ) showed that patients who received PGT plus clonazepam presented significantly greater improvement than those who received clonazepam ( P=0.033 ) . There were no significant differences between the two groups in the secondary efficacy measures . CONCLUSIONS Our study suggests that the combination of PGT with clonazepam may be a promising strategy for the treatment of GSAD , regarding gains in the global functioning . However the present study failed to detect more specific changes in social anxiety symptomatology between the two groups",
"The aim of this study was to evaluate the efficacy , tolerability , and effects on quality of life of sertraline , a selective serotonin reuptake inhibitor , in the prevention of relapse of generalized social phobia . Fifty adult out patients with generalized social phobia who were rated much or very much improved on the Clinical Global Impression Scale of Improvement ( CGI-I ) after 20 weeks of sertraline treatment ( 50 - 200 mg/day ) were r and omly assigned in a one-to-one ratio to either continue double-blind treatment with sertraline or immediately switch to placebo for another 24 weeks . The initial 20-week study was placebo-controlled , and 15 responders to placebo also continued to receive double-blind placebo treatment in the continuation study . Eighty-eight percent of patients in the sertraline-continuation group and only 40 % of patients in the placebo-switch and placebo-responder groups completed the study . In intent-to-treat endpoint analyses , 1 ( 4 % ) of 25 patients in the sertraline-continuation group and 9 ( 36 % ) of 25 patients in the placebo-switch group had relapsed at study endpoint ( chi2 = 8.0 , Fisher exact test , p = 0.01 ) . The relative risk ( hazards ratio ) for relapse associated with placebo-switch relative to sertraline-continuation treatment was 10.2 ( 95 % confidence interval , 1.3 - 80.7 ) . Mean CGI-Severity , Marks Fear Question naire ( MFQ ) Social Phobia subscale , and Duke Brief Social Phobia Scale ( BSPS ) total scores were reduced by 0.07 , 0.34 , and 1.86 in the Sertraline-Continuation group and increased by 0.88 , 4.09 , and 5.99 in the Placebo-Switch group ( all F > 5.3 , p CGI-Severity , MFQ Social Phobia subscale , and BSPS scores also increased in the Placebo-Responder group . Discontinuations because of lack of efficacy were 4 % in the sertraline-continuation group , 28 % in the placebo-switch group ( chi2 = 5.36 , Fisher exact test , p = 0.049 ) , relative to sertraline , and 27 % in the placebo-responder group . Sertraline was effective in preventing relapse of generalized social phobia . Future research should assess whether improvements may be maintained or further increased by longer periods of treatment or through the addition of cognitive-behavioral techniques",
"BACKGROUND This article presents results of the acute treatment phase of a 2-site study comparing cognitive behavioral group therapy ( CBGT ) and treatment with the monoamine oxidase inhibitor phenelzine sulfate for social phobia . METHODS One hundred thirty-three patients from 2 sites received 12 weeks of CBGT , phenelzine therapy , pill placebo administration , or educational-supportive group therapy ( an attention-placebo treatment of equal credibility to CBGT ) . The \" allegiance effect , \" ie , the tendency for treatments to seem most efficacious in setting s of similar theoretical orientation and less efficacious in theoretically divergent setting s , was also examined by comparing responses to the treatment conditions at both sites : 1 known for pharmacological treatment of anxiety disorders and the other for cognitive behavioral treatment . RESULTS After 12 weeks , phenelzine therapy and CBGT led to superior response rates and greater change on dimensional measures than did either control condition . However , response to phenelzine therapy was more evident after 6 weeks , and phenelzine therapy was also superior to CBGT after 12 weeks on some measures . There were few differences between sites , suggesting that these treatments can be efficacious at facilities with differing theoretical allegiances . CONCLUSIONS After 12 weeks , both phenelzine therapy and CBGT were associated with marked positive response . Although phenelzine therapy was superior to CBGT on some measures , both were more efficacious than the control conditions . More extended cognitive behavioral treatment and the combination of modalities may enhance treatment effect",
"The objective of this study was to evaluate the efficacy and tolerability of pregabalin for the treatment of generalized social anxiety disorder ( SAD ) . Patients with generalized SAD , who met the Diagnostic and Statistical Manual of Mental Disorders ( fourth edition ) criteria ( total N=329 ) , were r and omly assigned to 11 weeks of double-blind treatment with fixed daily doses of either pregabalin ( 300 , 450 , and 600(mg ) or placebo . The treatment with pregabalin ( 600(mg ) was associated with a significantly greater mean reduction in the Liebowitz Social Anxiety Scale total score , from baseline to endpoint , compared with placebo ( -29.8 vs. -19.7 ; P= 0.0099 ) , whereas reduction on pregabalin ( 300(mg , -20.2 ) and pregabalin ( 450(mg , -25.5 ) was not significant Treatment with pregabalin ( 600(mg ) was also associated with a significantly greater improvement than placebo on the fear and avoidance subscales of the Liebowitz Social Anxiety Scale , as well as the majority of other secondary measures . Onset of improvement occurred by week 1 in the pregabalin 600-mg dose group . The most common adverse events on all three doses of pregabalin were somnolence and dizziness . Consistent with a previous study , the results of this study suggest that the 600-mg dose of pregabalin per day may be efficacious in the treatment of SAD",
"OBJECTIVE This is the first trial examining duloxetine for generalized social anxiety disorder ( GSAD ) and the effect of increased dose for those without early remission . METHODS Individuals ( n=39 ) with GSAD received 6 weeks of open-label duloxetine 60 mg/day ; those with a Liebowitz Social Anxiety Disorder Scale ( LSAS ) score > 30 at week 6 were r and omized in double-blind fashion to an additional 18 weeks of continued duloxetine 60 mg/day or to duloxetine 120 mg/day . RESULTS Duloxetine was associated with a significant LSAS reduction at week 6 ( 91.3 [ 17.7 ] to 69.8 [ 28.5 ] , paired t [df]=5.2 [ 38 ] , P LSAS reduction ( 20.5 [ 26.0 ] versus 7.3 [ 17.2 ] , t [df]=1.6 [ 26 ] , P=.13 ) nor remission ( 33 % versus 8 % ) for duloxetine with dose increased to 120 mg/day compared to duloxetine continued at 60 mg/day . Overall , 44 % ( 17/39 ) discontinued prior to week 24 . CONCLUSIONS Though with limited power , these data provide preliminary support for the efficacy of duloxetine for GSAD , and suggest continued improvement but limited remission overall at 24 weeks for individuals remaining symptomatic at week 6 . These observations warrant further controlled study",
"BACKGROUND No controlled trial of treatment of generalised social phobia has been conducted in general practice . AIMS To examine the efficacy of sertraline or exposure therapy , administered alone or in combination in this setting . METHOD Study was of a r and omised , double-blind design . Patients ( n = 387 ) received sertraline 50 - 150 mg or placebo for 24 weeks . Patients were additionally r and omised to exposure therapy or general medical care . RESULTS Sertraline-treated patients were significantly more improved than non-sertraline-treated patients ( chi(2)=12.53 , P No significant difference was observed between exposure- and non-exposure-treated patients ( chi(2)=2.18 , P=0.140 ; odds ratio=0.732 ; 95 % Cl 0.475 - 1.134 ) . In the pairwise comparisons , combined sertraline and exposure ( chi(2)=12.32 ; P sertraline ( chi(2)=10.13 ; P=0.002 ) were significantly superior to placebo . CONCLUSIONS Sertraline is an effective treatment for generalised social phobia . Combined treatment with sertraline and exposure therapy , conducted by the general practitioner , may enhance the treatment efficacy in primary care",
"The objective of the study was to examine the efficacy of fluoxetine in social phobia . Sixty subjects were r and omly assigned to 14 weeks of double-blind therapy with either fluoxetine or placebo . Dose was fixed at 20 mg for fluoxetine during the first 8 weeks of double-blind treatment ; during the final 6 weeks , the dose could be increased every two weeks by 20 mg to a maximum of 60 mg/day . An intentto-treat analysis was used . A significant change from baseline to endpoint was found for both fluoxetine and placebo on the Liebowitz Social Anxiety Scale . However , no significant difference was found between fluoxetine and placebo . The change for fluoxetine was somewhat lower than that found with other selective serotonin reuptake inhibitors , whereas the placebo response was greater . Fluoxetine failed to separate from placebo in this trial . It is unknown whether a larger dose for longer duration would have yielded separation from placebo . A higher than usual placebo response rate was found",
"Escitalopram has demonstrated efficacy for the acute treatment of social anxiety disorder ( SAD ) in two placebo-controlled trials and for long-term treatment in a relapse-prevention study . Social anxiety disorder is a heterogeneous disorder . This study questions whether this new selective serotonin reuptake inhibitor is effective across different subgroups of patients . Data from two r and omised , placebo-controlled , 12-week escitalopram SAD trials were pooled . General linear models were used to determine the efficacy of escitalopram in different patient subgroups . Furthermore , a factor analysis of the primary efficacy scale , the Liebowitz Social Anxiety Scale ( LSAS ) , was undertaken , and a determination made of whether treatment effects were similar for the different symptom dimensions . Escitalopram was effective in both younger and older patients , in male and female patients , and in patients with more and less severe social anxiety symptoms . The LSAS factor analysis showed six factors , which were differentially associated with different areas of disability . Escitalopram was significantly superior to placebo for all six symptom dimensions . The treatment effects of escitalopram were independent of gender , symptom severity and chronicity , and comorbid depressive symptoms . A six-factor model of social anxiety symptoms is supported by the distinctive association between these symptom dimensions and different areas of disability , but did not predict differential response to escitalopram",
"Social phobia ( social anxiety disorder ) is a highly prevalent and chronic disorder that is associated with significant comorbidity and disability . Despite recent advances in the pharmacotherapy of the disorder , there is a paucity of r and omized controlled trials on patients with comorbid disorders and on maintenance treatment . A r and omized placebo-controlled , double-blind multi-site trial of moclobemide , a reversible inhibitor of monoamine oxidase A , was undertaken with 390 subjects . After an initial 12 weeks , there was the option of continuing for an additional 6 months of treatment . The primary efficacy parameter chosen was responder status as defined by the Clinical Global Impression scale change item . From week 4 onwards , there was a significantly higher response rate on moclobemide than on placebo . Superiority of medication over placebo was similar in patients with comorbid anxiety disorders ( 33 % of subjects ) and without , as well as in patients with different subtypes of social anxiety disorder ; indeed , treatment with moclobemide rather than placebo was the strongest predictor of response . Adverse events were similar across treatment groups , and were typically mild and transient . In the extension phase , response rates remained higher in the moclobemide group , and ratings of tolerability were equally high in both groups . Thus , in a large sample of social anxiety disorder patients with and without comorbid anxiety disorders , moclobemide was both effective and well-tolerated in the short as well as long-term . These data confirm and extend previous findings on the value of moclobemide in the treatment of social anxiety disorder , and strengthen the range of therapeutic options for managing this important disorder",
"Patients with social phobia who responded well to 6 months of open-label treatment with clonazepam were assigned to receive either continuation treatment ( CT ) with clonazepam for another 5 months , or to undergo discontinuation treatment ( DT ) using a clonazepam taper at the rate of 0.25 mg every 2 weeks , with double-blind placebo substitution . Clinical efficacy was compared between the CT and DT groups using three different social phobia scales . Benzodiazepine withdrawal symptoms were also measured . Relapse rates were 0 and 21.1 % in the CT and DT groups , respectively . Subjects in the CT group generally showed a more favorable clinical response at midpoint and /or endpoint , although even in the DT group clinical response remained good . With respect to withdrawal symptoms , the rates were low in both groups ( 12.5 % for CT and 27.7 % for DT ) with no real evidence suggesting significant withdrawal difficulties . At the end of 11 months of treatment with clonazepam , however , a more rapid withdrawal rate was associated with greater distress . This study offers preliminary evidence to suggest that continuation therapy with clonazepam in the treatment of social phobia is safe and effective , producing a somewhat greater clinical benefit than a slow-taper discontinuation regime . However , even in the DT group , withdrawal symptoms were not found to be a major problem . The study can be taken as supportive of benefit for longterm clonazepam treatment in social phobia , as well as being compatible with a reasonably good outcome after short-term treatment and slow taper",
"We report the results of an 8-week open trial of imipramine in 15 patients with social phobia . Nine patients completed the trial ; six dropped out early because of adverse effects . The mean reduction in the Liebowitz Social Anxiety Scale was 15 % and 18 % for the intent-to-treat and completer groups , respectively ; the overall response rate ( based on the Clinical Global Impression Scale of 1 or 2 , very much or much improved ) was 20 % ( 3/15 ) and 22 % ( 2/9 ) , respectively . The results from this open trial do not support the efficacy of imipramine as a treatment for social phobia",
"We summarise a series of studies using a MAOI to help establish the validity of a subgroup of depressives referred to as atypical depressives . Patients with reactive mood meeting DSM-III criteria for depressive illness who had associated atypical features ( which include hyperphagia , hypersomnolence , leaden paralysis , and rejection sensitivity ) were r and omised to imipramine , phenelzine and placebo . Non-responders were crossed over , and in all there were over 400 patient trials . Phenelzine consistently was found to be superior to imipramine . Only in trials which included patients lacking atypical , vegetative symptoms was imipramine found to equal phenelzine . We conclude that the research er and the clinician should consider the relevance of the atypical depressive syndrome",
"BACKGROUND Generalized social anxiety disorder is a debilitating psychiatric illness characterized by maladaptive thoughts about social situations . This double-blind study evaluated the anxiolytic efficacy , safety , and tolerability of venlafaxine extended release ( ER ) in adult out- patients with generalized social anxiety disorder . METHOD Patients were r and omly assigned to receive 12 weeks of treatment with a flexible dose of venlafaxine ER ( 75 to 225 mg/day ) or placebo . The Liebowitz Social Anxiety Scale ( LSAS ) total score was the primary efficacy variable . Secondary efficacy variables included scores on the Clinical Global Impressions-Severity of Illness ( CGI-S ) and -Improvement ( CGI-I ) scales , Social Phobia Inventory ( SPIN ) , and LSAS subscales . Response was defined as a CGI-I score of 1 or 2 . Two definitions of remission were used : LSAS total score CGI-I score of 1 . RESULTS Data from 271 patients ( intent-to-treat population ) were analyzed for efficacy ; 279 patients were analyzed for safety . Overall , 173 patients completed the study . Improvement on the LSAS was significantly greater with venlafaxine ER treatment than with placebo at weeks 6 through 12 ( p CGI-S and SPIN scores . Week 12 response and remission ( LSAS score were significantly greater in the venlafaxine ER group than in the placebo group ( response : 44 % vs. 30 % , respectively , p = .018 ; remission : 20 % vs. 7 % , respectively , p unexpected or serious adverse events . CONCLUSION Venlafaxine ER is safe , well tolerated , and efficacious in the short-term treatment of generalized social anxiety disorder",
"OBJECTIVE Numerous studies have demonstrated the efficacy of serotonergic antidepres-sants , particularly the selective serotonin reuptake inhibitors ( SSRIs ) , in the treatment of social phobia . We evaluated the efficacy , safety , and tolerability of nefazodone , a 5-HT(2 ) antagonist , in patients with generalized social phobia ( GSP ) . METHOD One hundred five patients with GSP ( confirmed using the Structured Clinical Interview for DSM-IV ) from 4 Canadian outpatient anxiety clinics were assigned r and omly to nefazodone ( 300 - 600 mg/day , flexible dose ) or placebo for 14 weeks of double-blind treatment . Data were collected from October 12 , 1999 , through December 8 , 2001 . Primary efficacy outcomes were the Clinical Global Impressions-Improvement scale ( CGI-I ) score and the Liebowitz Social Anxiety Scale score . RESULTS In the intent-to-treat sample , 16 ( 31.4 % ) of 51 subjects taking nefazodone and 12 ( 23.5 % ) of 51 subjects taking placebo were rated as much or very much improved on the CGI-I at endpoint ( chi(2 ) = 0.79 , p = .38 ) . With the exception of the Social Phobia Scale , no significant differences were found in measures of social phobia when comparing the nefazodone and placebo groups . CONCLUSION These findings suggest that nefazodone is not an effective agent in the treatment of GSP . These data parallel some recent findings with the use of the SSRI fluoxetine in GSP . The lack of efficacy of 2 serotonergic antidepressants in GSP suggests that serotonin reuptake inhibition may not be the only mechanism of action required for efficacy to occur in the treatment of GSP",
"The safety and efficacy of brofaromine , a reversible and selective monoamine oxidase inhibitor , were examined in a multicenter trial of 102 out patients with social phobia . After a 1-week placebo washout , subjects were r and omly assigned to 10 weeks of treatment with either brofaromine ( N = 52 ) or placebo ( N = 50 ) . Brofaromine dosage began at 50 mg/day and was titrated to a maximum of 150 mg/day , depending on treatment response . Brofaromine produced a significantly greater change from baseline in Liebowitz Social Anxiety Scale ( LSAS ) scores compared with placebo , F(1 ) = 6.01 , p Mean LSAS scores decreased from 81.8 at baseline to 62.6 at endpoint for brofaromine , t = 5.41,p placebo , t = 3.66 , p 14 brofaromine early terminators discontinued because of adverse experiences , as did 4 of the 17 placebo early terminators . Side effects more common with brofaromine than placebo included insomnia , dizziness , dry mouth , anorexia , tinnitus , and tremor . No clinical ly significant variations in vital signs or laboratory values were found . The findings are consistent with the clinical efficacy for the treatment of social phobia",
"CONTEXT Medication and cognitive behavioral treatment are the best-established treatments for social anxiety disorder , yet many individuals remain symptomatic after treatment . OBJECTIVE To determine whether combined medication and cognitive behavioral treatment is superior to either monotherapy or pill placebo . DESIGN R and omized , double-blind , placebo-controlled trial . SETTING Research clinics at Columbia University and Temple University . PARTICIPANTS One hundred twenty-eight individuals with a primary DSM-IV diagnosis of social anxiety disorder . INTERVENTIONS Cognitive behavioral group therapy ( CBGT ) , phenelzine sulfate , pill placebo , and combined CBGT plus phenelzine . MAIN OUTCOME MEASURES Liebowitz Social Anxiety Scale and Clinical Global Impression ( CGI ) scale scores at weeks 12 and 24 . RESULTS Linear mixed-effects models showed a specific order of effects , with steepest reductions in Liebowitz Social Anxiety Scale scores for the combined group , followed by the monotherapies , and the least reduction in the placebo group ( Williams test = 4.97 , P CGI response rates in the intention-to-treat sample at week 12 were 9 of 27 ( 33.3 % ) ( placebo ) , 16 of 34 ( 47.1 % ) ( CBGT ) , 19 of 35 ( 54.3 % ) ( phenelzine ) , and 23 of 32 ( 71.9 % ) ( combined treatment ) ( chi(2)(1 ) = 8.76 , P Corresponding remission rates ( CGI = 1 ) were 2 of 27 ( 7.4 % ) , 3 of 34 ( 8.8 % ) , 8 of 35 ( 22.9 % ) , and 15 of 32 ( 46.9 % ) ( chi(2)(1 ) = 15.92 , P response rates were 9 of 27 ( 33.3 % ) , 18 of 34 ( 52.9 % ) , 17 of 35 ( 48.6 % ) , and 25 of 32 ( 78.1 % ) ( chi(2)(1 ) = 12.02 , P = .001 ) . Remission rates were 4 of 27 ( 14.8 % ) , 8 of 34 ( 23.5 % ) , 9 of 35 ( 25.7 % ) , and 17 of 32 ( 53.1 % ) ( chi(2)(1 ) = 10.72 , P = .001 ) . CONCLUSION Combined phenelzine and CBGT treatment is superior to either treatment alone and to placebo on dimensional measures and on rates of response and remission",
"Objective : To compare the effectiveness of Internet cognitive behaviour therapy ( CBT ) with face-to-face CBT in social phobia . Methods : R and omized controlled trial of 75 patients with social phobia referred to an anxiety disorders clinic . A total of 37 patients participated , and post-treatment data was obtained from 25 Subjects ( Ss ) . An intention to treat analysis was used . The same therapist ( M.D. ) treated both groups . Results : Both groups made significant progress on symptoms and disability measures . There were no significant differences in outcome between the Internet and face-to-face groups . The total amount of therapist time required was 18 min per patient for the Internet group and 240 min per patient for the face-to-face group . Conclusions : Both forms of treatment were equally effective and this is consistent with previous findings in depression and panic disorder . The difference in clinician time required was substantial . If Internet CBT was offered as ‘ st and ard of care ’ the staff time saved would permit a stepped care model in which in-depth therapy for the difficult to recover patients could be provided without an increase in staff",
"OBJECTIVE This multicenter , double-blind , placebo-controlled , 2-arm , parallel-group study was carried out to determine the effectiveness and safety of the novel anticonvulsant levetiracetam for the treatment of generalized social anxiety disorder ( GSAD ) . METHOD After a 1-week , single-blind , placebo run-in period , 217 adult out patients meeting DSM-IV criteria for social anxiety disorder , generalized type , were r and omly assigned ( 1:1 ) to 12 weeks of double-blind treatment with either levetiracetam ( n = 111 ) or placebo ( n = 106 ) . Participants were required to have scores of > or= 60 on the Liebowitz Social Anxiety Scale ( LSAS ) and a total score of Hamilton Depression Rating Scale ( HDRS ) . The primary outcome measure was mean change from baseline on LSAS total score . Levetiracetam was initiated at 250 mg/d and flexibly titrated up to a maximum dose of 3,000 mg/d ( 1,500 mg bid ) . Dosage was held stable for the last 6 weeks of treatment . The study was conducted from September 2003 to June 2004 . RESULTS No statistically significant difference was found between the adjusted mean changes in LSAS score for levetiracetam ( -24.4 ) and placebo ( -28.7 ) using an efficacy intent-to-treat , last- observation-carried-forward analysis . Rates of response ( > or= 30 % reduction in LSAS score ) were similar with 41.3 % ( levetiracetam ) and 46.6 % ( placebo ) . No significant between-group differences were found on secondary outcome measures , which included changes in Sheehan Disability Scale , Clinical Global Impression of Change , and HDRS scores . CONCLUSIONS Although well-tolerated , levetiracetam failed to separate from placebo in this trial for the treatment of moderate to severe GSAD",
"BACKGROUND Preliminary studies have suggested that paroxetine may be effective in social phobia/social anxiety disorder . AIMS To assess the efficacy and tolerability of paroxetine in the acute ( 12-week ) treatment of social phobia . METHOD Two-hundred and ninety patients with social phobia were assigned r and omly to paroxetine ( 20 - 50 mg/day flexible dose ) or placebo for 12 weeks of double-blind treatment . Primary efficacy outcomes were the Liebowitz Social Anxiety Scale ( LSAS ) total score ( patient-rated ) and the Clinical Global Impression ( CGI ) scale global improvement item . The secondary efficacy variables included CGI scale severity of illness score and the patient-rated Social Avoidance and Distress Scale . RESULTS Paroxetine produced a significantly greater reduction in LSAS total score ( mean change from baseline : -29.4 v. -15.6 ; P ) ( 65.7 % v. 32.4 % ; P placebo from week 4 onwards . Paroxetine was generally well tolerated . CONCLUSIONS Paroxetine is an effective , well-tolerated treatment for patients with social phobia",
"BACKGROUND Generalized social anxiety disorder ( GSAD ) is a pervasive form of social anxiety that affects approximately 5 % of persons in the community . Among evidence -based pharmacologic treatments for the disorder , selective serotonin reuptake inhibitors ( SSRIs ) have become widely used and are known to be efficacious . Monotherapy with the benzodiazepine clonazepam is also efficacious for GSAD , but the adjunctive use of clonazepam with an SSRI to potentially improve outcomes has not been studied to date . METHOD Twenty-eight patients ( 22 men and 6 women ) with DSM-IV-defined GSAD were r and omly assigned to receive double-blind clonazepam ( or placebo ) , 1.0 to 2.0 mg/day ( divided b.i.d . ) along with open-label paroxetine , 20 to 40 mg/day , for 10 weeks . A 2-week taper of double-blind medication was followed by an additional 8 weeks of open-label paroxetine treatment ( during which the dose of paroxetine could be increased to a maximum of 50 mg/day ) . Twenty-three patients ( 82 % ) met DSM-IV criteria for avoidant personality disorder . The patients ' mean + /- SD age was 31.2 + /- 7.7 years , and their mean duration of illness was 12.1 + /- 5.8 years . Data were gathered from August 2001 to April 2002 . RESULTS Nineteen ( 68 % ) of 28 patients completed treatment . At the end of the 10-week double-blind treatment , there was a trend ( p paroxetine/clonazepam group , who had a 79 % response rate ( Clinical Global Impressions-Global Improvement scale [ CGI-I ] score of 1 or 2 ) compared with a 43 % response rate for the paroxetine/placebo group . However , no significant differences on other outcome measures were noted between the 2 groups in an intent-to-treat analysis , in terms of either very early ( 2 - 4 weeks ) or not as early ( 5 - 10 weeks ) responses during treatment . Dropout rates due to adverse events were rare ( 1 patient in each group ) , indicating that the paroxetine/clonazepam combination was well tolerated . CONCLUSION Coadministration of clonazepam with an SSRI , in contrast to findings in panic disorder , did not lead to more rapid resolution of symptoms in GSAD . On the other h and , there is some evidence that the clonazepam-added group had superior global outcomes ( e.g. , as measured on the CGI-I ) , although power to detect such differences in this study was small . These observations suggest that a role for adjunctive benzodiazepines in patients with GSAD ( e.g. , for augmenting SSRI partial response or nonresponse ) is deserving of further controlled investigation",
"There is circumstantial evidence that antidepressants , particularly monoamine oxidase inhibitors ( MAOIs ) and beta-blockers , may have some beneficial effects in social phobia . In this study 30 patients with social phobia ( DSM-IIIR ) were treated with the selective and reversible MAO-A inhibitor brofaromine , using a 12-week double-blind placebo controlled design . A clinical relevant improvement was seen in 80 % of the patients treated with brofaromine ( 150 mg daily ) . A significant improvement was found on measures of social anxiety , phobic avoidance , general ( or anticipatory ) anxiety and interpersonal sensitivity in patients on brofaromine , but not on placebo . Biochemical measurements revealed a decrease in turnover of noradrenaline , serotonin and dopamine as assessed by the plasma metabolite levels , and an increase in nocturnal release of melatonin . Most prominent side-effect was middle sleep disturbance . No changes in blood pressure were observed . During a follow-up period of 12 weeks a further improvement was found in patients treated with brofaromine",
"Abstract : Pregabalin is a novel compound in the development for the treatment of anxiety disorders . The safety and efficacy of pregabalin for the treatment of social anxiety disorder was evaluated in a double-blind , multicenter clinical trial in which 135 patients were r and omized to 10 weeks of double-blind treatment with either pregabalin 150 mg/d , pregabalin 600 mg/d , or placebo . The primary efficacy parameter was change from baseline to end point in the Liebowitz Social Anxiety Scale ( LSAS ) total score . Safety was assessed through clinical and laboratory monitoring , and recording spontaneously reported adverse events . Ninety-four patients ( 70 % ) completed the 11-week double-blind treatment phase . LSAS total score was significantly decreased by pregabalin 600 mg/d treatment compared with placebo ( P = 0.024 , analysis of covariance ) . Significant differences ( P ≤ 0.05 ) between pregabalin 600 mg/d and placebo were seen on several secondary measures including the LSAS subscales of total fear , total avoidance , social fear , and social avoidance , and the Brief Social Phobia Scale fear subscale . Pregabalin 150 mg/d was not significantly better than placebo on any measures . Somnolence and dizziness were the most frequently occurring adverse events among patients receiving pregabalin 600 mg/d . In conclusion , pregabalin 600 mg/d was an effective and well-tolerated treatment of social anxiety disorder",
"& NA ; The aim of the study was to examine the efficacy of valproic acid in participants with social anxiety disorder . Following a 2‐week single‐blind , placebo run‐in period , 17 participants were enrolled in a 12‐week open flexible‐dose trial of valproic acid ( 500‐2500 mg ) . The primary outcome measures were the mean change from baseline in the Liebowitz Social Anxiety Scale ( LSAS ) total score and responder status [ defined as a Clinical Global Impression of Improvement score ( CGI‐I ) ≤ 2 ] . Social anxiety symptoms as measured by the LSAS and CGI‐I scores significantly improved with treatment . The mean reduction in the LSAS was 21.3 points in the last visit carried forward analysis and 19.1 points for the completer analysis , with 41.1 % and 46.6 % participants , respectively , achieving responder status . The results from this open‐label trial suggest the potential efficacy of valproic acid for the treatment of social anxiety disorder . Placebo‐controlled trials are indicated to confirm these findings",
"OBJECTIVE Escitalopram has proven efficacy in the short-term treatment of generalized social anxiety disorder ( SAD ) . The present relapse prevention study investigated relapse rates during a 24-week , r and omized , double-blind , placebo-controlled period in patients with generalized SAD who had responded to 12-week open-label treatment with escitalopram . METHOD A total of 517 patients with a primary diagnosis of generalized SAD ( per DSM-IV criteria ) and a Liebowitz Social Anxiety Scale ( LSAS ) total score of > or = 70 received 12 weeks of open-label treatment with flexible doses ( 10 - 20 mg/day ) of escitalopram . Of these patients , 371 responded ( Clinical Global Impressions-Improvement scale [ CGI-I ] score of 1 or 2 ) and were r and omly assigned to 24 weeks of double-blind treatment with escitalo-pram ( 10 or 20 mg/day ) ( N = 190 ) or placebo ( N = 181 ) , continuing with the dose level administered at the end of the open-label period . Relapse was defined as either an increase in LSAS total score of > or = 10 or withdrawal due to lack of efficacy , as judged by the investigator . The study was conducted from January 2001 to June 2002 . RESULTS Survival analysis of relapse and time to relapse showed a significant advantage for escitalopram compared to placebo ( log-rank test : p risk of relapse was 2.8 times higher for placebo-treated patients than for escitalopram-treated patients ( p escitalopram-treated patients relapsing ( 22 % vs. 50 % ) , at both doses . Escitalopram was well tolerated during double-blind treatment of generalized SAD , and only 2.6 % of the escitalopram-treated patients withdrew because of adverse events . The overall discontinuation rate , excluding relapses , was 13.2 % for patients treated with escitalopram and 8.3 % for patients treated with placebo . CONCLUSION Escitalopram was effective and well tolerated in the long-term treatment of generalized SAD",
"Abstract : Venlafaxine extended release ( ER ) is a dual serotonin-norepinephrine reuptake inhibitor previously shown to be effective in the treatment of major depressive disorder and generalized anxiety disorder . This placebo-controlled , multicenter , r and omized , double-blind trial examined the efficacy and safety of venlafaxine ER in out patients with generalized social anxiety disorder . Two hundred seventy-two out patients were r and omly assigned to receive either a flexible dose of venlafaxine ER ( 75 to 225 mg/d ) or placebo for 12 weeks . Venlafaxine ER was statistically significantly more effective than placebo as demonstrated by the Liebowitz Social Anxiety Scale total scores at weeks 4 to 12 . Scores of both the Clinical Global Impression-Severity and Clinical Global Impression-Improvement scales showed that venlafaxine ER was significantly more effective than placebo at weeks 4 to 12 . In addition , more venlafaxine ER-treated patients achieved CGI-Improvement scores of 1 or 2 than placebo-treated patients at weeks 4 to 12 , demonstrating a greater percentage of responders to venlafaxine ER treatment . Assessment using the fear/anxiety and avoidance subscales of the Liebowitz Social Anxiety Scale and the Social Phobia Inventory Scale also showed venlafaxine ER to be more effective than placebo at weeks 4 to 12 and 6 to 12 , respectively . The Sheehan Disability Inventory showed that patients in the venlafaxine ER-treated group had significantly better outcomes in social life at weeks 4 and 12 , and in work at week 12 . Adverse events were similar to those reported in studies of venlafaxine ER in depression and generalized anxiety disorder . Venlafaxine ER was safe , well tolerated , and efficacious in the short-term treatment of generalized social anxiety disorder",
"This study evaluated the anxiolytic efficacy , safety and tolerability of a flexible dose of venlafaxine extended release ( ER ) compared with placebo and paroxetine in the short‐term treatment of generalized social anxiety disorder ( SAD ) . Adult out patients with generalized SAD ( n = 434 ) were r and omized to receive capsules of venlafaxine ER 75 mg to 225 mg/day , paroxetine 20 mg to 50 mg/day , or placebo for 12 weeks . The primary efficacy variable was the Liebowitz social anxiety scale total score . Secondary efficacy variables included the patient‐rated social phobia inventory and the proportion of responders in each group ( a responder was defined as having a clinical global impression‐improvement score of 1 or 2 ) . Treatment with venlafaxine ER was associated with significantly greater improvement than treatment with placebo for all primary and secondary efficacy variables ( p in primary or secondary efficacy variables were observed between the venlafaxine ER and paroxetine groups . The week 12 response rates were 69 % , 66 % and 36 % for the venlafaxine ER , paroxetine and placebo groups , respectively . Both active treatments were generally well tolerated and were associated with a similar incidence of adverse events . This study shows that venlafaxine ER is an effective , safe and well‐tolerated drug treatment for SAD . Copyright © 2004 John Wiley & Sons ,",
"Seventy-four patients who met DSM-III criteria for social phobia completed 8 weeks of double-blind , r and omly assigned treatment with the monoamine oxidase inhibitor phenelzine sulfate , the cardioselective beta-adrenergic blocker atenolol , or placebo . The overall response rates were 64 % for phenelzine , 30 % for atenolol , and 23 % for placebo . Phenelzine was widely superior to both atenolol and placebo on independent rater analyses and , to a lesser extent , on self-report , with no significant differences between atenolol and placebo . At the end of 16 weeks , phenelzine was still significantly superior to placebo , while atenolol showed an intermediate response that did not differ significantly from either of the other treatments . Patients with generalized social phobia constituted 76 % of the sample , and they were preferentially responsive to phenelzine . The small size of the discrete social phobic sample precluded separate outcome analyses for this subtype . Overall , the findings support the responsivity of social phobia to monoamine oxidase inhibitors",
"BACKGROUND This multicenter , double-blind , placebo-controlled study was carried out to determine the effectiveness and safety of various daily dosages of paroxetine for the treatment of generalized social anxiety disorder . METHOD A 1-week , single-blind , placebo run-in was followed by 12 weeks of double-blind treatment . 384 eligible patients meeting DSM-IV criteria for social anxiety disorder were r and omly assigned to receive paroxetine , 20 ( N = 97 ) , 40 ( N = 95 ) , or 60 mg ( N = 97 ) , or placebo ( N = 95 ) once daily in a 1:1:1:1 ratio . Primary efficacy variables included mean change from baseline in the Liebowitz Social Anxiety Scale ( LSAS ) total score and proportion of patients exhibiting a therapeutic response ( defined as a Clinical Global Impressions-Global Improvement scale [ CGI-1 ] score of 1 or 2 ) . RESULTS In the last-observation-carried-forward analyses , patients treated with paroxetine , 20 mg/day , had significantly greater improvement on mean LSAS total scores compared with those receiving placebo ( p CGI-I rating , was significantly greater with paroxetine , 40 mg/day , than with placebo ( p = .012 ) . Patients treated with paroxetine , 20 and 60 mg , also had significantly better responses on the social item of the Sheehan Disability Scale than did patients treated with placebo ( p placebo group and the 20-mg and 40-mg paroxetine groups on LSAS total score and rate of response ( p adverse experiences attributed to paroxetine treatment . CONCLUSION Paroxetine , 20 mg/day , is an effective and safe treatment for patients with generalized social anxiety disorder and significantly improves social anxiety , avoidance of social interactions , social disability , and overall clinical condition . Further data analyses are needed to determine whether more specific guidelines for paroxetine dosage escalation in social anxiety disorder can be drawn",
"In a double-blind , parallel group trial , 78 subjects with social phobia received moclobemide ( a new reversible inhibitor of monoamine oxidase A ) phenelzine , or placebo . After eight weeks , both active drugs-phenelzine somewhat more than moclobemide -- were clinical ly and statistically significantly more effective than placebo , as assessed by rating scales . There was some further improvement between weeks 8 and 16 , particularly in the moclobemide group ; at week 16 , 82 % of the moclobemide and 91 % of the phenelzine-treated patients were almost asymptomatic . Moclobemide was , however , much better tolerated than phenelzine . Patients withdrawn from active drugs had relapsed by week 24 , providing additional support for the efficacy of the active drugs",
"Based on evidence suggesting anxiolytic properties of the atypical antipsychotic olanzapine , this study was conducted to evaluate whether olanzapine may be efficacious in treating social anxiety disorder ( SAD ) . This study was an 8-week , double-blind , placebo-controlled evaluation of olanzapine as monotherapy in which 12 patients with the DSM-IV diagnosis of SAD were r and omized to either olanzapine ( n= 7 ) or placebo ( n= 5 ) . An initial dose of 5 mg/day was titrated to a maximum of 20 mg/day . Baseline to endpoint scores from the Brief Social Phobia Scale ( BSPS ) , Social Phobia Inventory ( SPIN ) , Liebowitz Social Anxiety Scale and Sheehan Disability Scale , as well as Clinical Global Impression-Improvement ratings , were compared for olanzapine versus placebo . Seven subjects completed all 8 weeks of the study , four in the olanzapine group and three in the placebo group . In the intent-to-treat analysis , olanzapine yielded greater improvement than placebo on the primary measures : BSPS ( p= 0.02 ) and SPIN ( p= 0.01 ) . Both treatments were well tolerated , although the olanzapine group had more drowsiness and dry mouth . Olanzapine and placebo were both associated with negligible weight gain . Olanzapine was superior to placebo on the primary outcome measures in this preliminary study of SAD . Additional studies of olanzapine as a treatment for SAD are warranted",
"OBJECTIVE The purpose of this study was to examine the use of benzodiazepines ( BZs ) and selective serotonin reuptake inhibitors/selective norepinephrine reuptake inhibitors ( SSRIs/SNRIs ) over nine years of follow-up in middle-aged and older adults with diagnoses of panic disorder with or without agoraphobia , social phobia , or generalized anxiety disorder . SETTING AND PARTICIPANTS Participants in this study were enrolled in the Harvard/Brown Anxiety Research Project ( HARP ) . HARP is a naturalistic , longitudinal , multisite study of adults with anxiety disorders who are recruited from psychiatric setting s. The analytic sample consisted of 51 participants with anxiety disorders who were 55 to 70 years old at baseline and a younger cohort of 211 participants added for comparative analysis . DESIGN The authors examined patterns of medication use ( BZs and SSRIs/SNRIs ) in participants with anxiety disorders as they aged , by assessing the proportion of participants taking these medications using generalized estimating equation modeling . MEASUREMENTS The present data were derived from the structured diagnostic interview administered at enrollment using a combination of the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders , Third Edition-R Non-Affective Disorder , Patient Version , Research Diagnostic Criteria Schedule for Affective Disorders-Lifetime , and subsequent follow-up interviews over a nine-year period using the Longitudinal Interval Follow-up Evaluation-Pharmacia & Upjohn to assess the weekly course of disorders to indicate syndrome severity and document medication use by specific type and dose on a weekly basis . RESULTS Findings showed that rates of BZ use were high among both the older ( 53 % at baseline ) and the younger ( 57.4 % ) age groups and did not significantly decrease over time , after controlling for time in episode of their anxiety disorders . There was a statistically significant increase in SSRI/SNRI use over time in both groups . At the beginning of the study , 18 % of the older group and 21 % of the younger group were using SSRIs/SNRIs ; however , at the end of the study , the rates increased to 35 % and 43 % , respectively . CONCLUSIONS Although there was an increase in SSRI/SNRI use in older participants with anxiety disorders over the course of study , at nine years of follow-up , only 35 % of participants were utilizing SSRI/SNRI medication , while more than one-half of the same participants were continuing to use BZs . To the authors ' knowledge , there are no r and omized clinical trials that have addressed comparative efficacy and safety of BZs and SSRIs/SNRIs in this population . However , there is documented evidence of adverse effects of chronic BZ use and the risk of developing dependency in older population "
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4117f474-06ff-11f0-808a-c43d1ab1c353
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Composite resin is used extensively for restoration of teeth with vital pulps . Although cell culture studies have disclosed harmful effects on pulpal cells , any untoward clinical effects , manifest as adverse pulpal responses , have yet to be determined . This study comprises a systematic review , design ed to address the question of whether the risk of endodontic complications is greater with composite resin restorations than with other restorative material s , such as amalgam . The study methodology involved ( i ) formulation of the research question , ( ii ) construction and conduct of an extensive literature search with ( iii ) interpretation and assessment of the retrieved literature . A search of the medical data base PubMed was complemented with a search of the Controlled Trials Register ( CENTRAL ) . The initial search yielded 1043 publications , the abstract s of which were read independently by the authors . After additional search es , 10 studies were included in the review . In all the included studies , the level of evidence was assessed as low . No conclusions could therefore be drawn . The included studies reported few , if any , endodontic complications . Little or no differences emerged between teeth restored with composite resins and those restored with amalgam . To determine whether composite resin restorations of teeth with vital pulps are associated with an increased risk for development of endodontic complications such as apical periodontitis , further evidence is needed , from well-constructed studies with a large number of participants
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"The purpose of this r and omized , clinical study was to evaluate the clinical performance of composite resin material s used for fillings and indirect inlays . Twenty-eight sets of five class II restorations ( two fillings , three inlays ) were placed in 88 premolars and 52 molars in 28 adults . Brilliant Dentin and Estilux Posterior were used for both fillings and inlays , and SR-Isosit for inlays only . After 11 years , 27 sets of restorations ( 96 % ) were evaluated clinical ly using modified United States Public Health Service criteria . Replaced or repaired restorations were observed in 16 % of the fillings and 17 % of the inlays , and a further 5 % of the restorations were replaced for reasons not related to the restoration . The remaining 107 restorations exhibited optimal ratings in 30 % of the fillings and 12 % of the inlays ( P acceptable ratings in 70 % and 88 % , respectively . The reasons for failure were fracture of restoration ( four fillings , five inlays ) , secondary caries ( two fillings , four inlays ) , fracture of tooth ( two inlays ) , loss of proximal contact ( two fillings ) , and loss of restoration ( one inlay ) . Failures were seen more frequently in molar than premolar restorations ( P0.05 )",
"OBJECTIVE The aim of this investigation was to evaluate the clinical performance of a new compomer restorative system , Dyract AP , placed in combination with Non-Rinse Conditioner and Prime & Bond NT in permanent posterior teeth . METHOD AND MATERIAL S Fifty Class II and 41 Class I restorations were placed in 39 patients by 1 dentist . The restorations were evaluated directly , with modified US Public Health Service criteria , and indirectly , with color slides and polyvinyl siloxane impressions , at baseline and 6 months and 1 year after placement . Preoperative and 1-year postoperative bitewing radiographs were also taken . RESULTS All 82 restorations available for 1-year evaluation were in situ . No postoperative sensitivity or pulpal problems were reported . Four Class II restorations ( 4.9 % ) failed because of partial fracture or recurrent caries . The percentages of Alfa score for each criterion were color match , 95.1 % ; marginal discoloration , 57.3 % ; marginal integrity , 35.4 % ; anatomic form , 98.8 % ; and surface texture , 91.5 % . The average wear rate of Dyract AP was low ( 18.5 + /- 11.7 microns at 6 months and 35.7 + /- 13.6 microns at 12 months ) . CONCLUSION The excellent h and ling characteristics , the good clinical performance , and the improved wear resistance suggest that this compomer will provide reliable direct tooth-colored restorations in stress-bearing areas",
"PURPOSE To report the 4-year clinical performance of posterior resin-based composite restorations placed using the total-etch technique . MATERIAL S AND METHODS Over a period of 1 year , 726 restorations ( 248 molars , 478 premolars ; 260 Class I , 466 Class II ; 540 replacements , 186 primary decay ) were placed on conservative preparations , using the incremental placement technique in a clinical environment . Baseline data were collected , and the restorations were evaluated after 4 years . Z100 and Scotchbond Multi- Purpose ( SBMP ) ( 3 M Dental Products , St. Paul , Minnesota ) were used as the restorative system . The criteria evaluated were color match , marginal adaptation , anatomic form , cavosurface marginal discoloration , axial contour , interproximal contact , secondary caries , postoperative sensitivity , and tooth vitality . RESULTS At baseline , 24 % of the teeth restored presented postoperative sensitivity ; 86 % of the sensitive teeth were from the replacement group . At 4 years , all teeth were vital to cold test . Eighteen restorations ( 2.5 % ) presented clinical ly detectable marginal fracture . The shade was acceptable in all restorations . Cavosurface marginal discoloration was observed in 47 restorations ( 6.5 % bravo scores ) . Axial contour , interproximal contact , and marginal adaptation received 100 % alfa scores . No secondary caries was diagnosed in any of the teeth examined . None of the examined restorations required replacement . CLINICAL SIGNIFICANCE Under controlled clinical conditions , posterior resin-based composite restorations placed with the total-etch technique and restorative Z100/SBMP have the potential to present a high success rate at 4 years . None of the examined restorations required replacement , and there was no clinical ly detectable wear in any of the restorations . Simultaneous etching of enamel and dentin followed by the application of a resin adhesive can be considered an adequate modality of pulp protection in nonexposed tooth preparations",
"PURPOSE This study evaluated the clinical efficacy of the \" open s and wich \" restoration for pediatric dental practice . METHODS Three pediatric dentists used a st and ardized preparation and restorative technique to place the restorations . The prepared tooth was etched with a phosphoric acid semigel and rinsed . A resin modified glass ionomer ( Fuji II LCor Photac-Fil ) was placed short of the margins and then light cured . The resin modified glass ionomer was covered with an occlusal layer of a microhybrid flowable composite ( Aeliteflo or Flow-it ) . The same preparation for the experimental restorations was used for the control conventional amalgam ( Tytin ) restorations . The restorations were evaluated at 6-month intervals and ranked with a modified United States Public Heath Survey ( USPHS ) scale as follows : Alfa : No discernible marginal opening or stain ; Beta : Slight opening of margin discernible with dental explorer , but without stain ; Charlie : Open margin and stain ; Delta : Recurrent caries or restoration failure . Restoration failures were categorized according to etiology , pulpal necrosis , bruxism , marginal leakage , isthmus fracture , or adhesive failure . RESULTS All recalled experimental restorations , except 8 , were rated as either Alpha or Beta . Six failed due to isthmus fracture and 2 due to pulpal necrosis . Fifteen restorations had delaminating of the flowable composite from the resin modified glass ionomer . The use of the \" open s and wich \" technique compared favorably with a similar study using adhesive amalgam restorations . CONCLUSIONS The \" open s and wich \" technique can be successfully used in a pediatric dental practice",
"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",
"OBJECTIVES The purpose of this study was to investigate the durability of extensive dentin-enamel-bonded posterior ceramic coverages in a 15 years follow-up . METHODS All extensive dentin-enamel-bonded posterior partial and complete all-ceramic coverages placed during the period November 1992-December 1998 were included . In 121 patients , 252 coverages ( IPS Empress ) were placed . The adhesive bonding to dentin and enamel was performed with three 3-step and one 2-step etch and rinse bonding . In 106 restorations the classic Syntac was used in combination with the dual-cured resin composite Variolink . The other restorations were luted with the chemically cured resin composite Bisfil 2B and bonded with 3-step etch and rinse systems , classic Gluma ( 37 ) , Allbond 2 ( 57 ) , Syntac ( 32 ) or the 2-step etch and rinse system , One step ( 20 ) . The ceramics were evaluated yearly by modified USPHS criteria during 15 years . RESULTS Postoperative sensitivity was registered in 4 patients during bite forces lasting for 2 - 4 weeks . Fifty-five of 228 coverages ( 24.1 % ) failed . The mean observation period of the acceptable coverages was 12.6 years ( range 11 - 15 years ) . The main reasons for failure were lost restorations ( 18 ) , ceramic fracture ( 16 ) , and secondary caries ( 11 ) . Significant differences in failure rate were observed between the dentin bonding agents but not between the two luting agents . Ceramic coverages placed on non-vital teeth failed in 39 % and on vital teeth in 20.9 % ( p=0.014 ) . Logistic regression indicated three significant predictors for failure of the coverages : gender and parafunctional habits of the patient and non-vitality of the tooth . SIGNIFICANCE The technique investigated showed advantages like less destruction of healthy tissue , and avoiding of endodontic treatment and /or deep cervical placement of restoration margins to obtain retention",
"Biocompatibility of dentin bonding agents ( DBA ) and composite resin may affect the treatment outcome ( e.g. , healthy pulp , pulpal inflammation , pulp necrosis ) after operative restoration . Bisphenol-glycidyl methacrylate ( BisGMA ) is one of the major monomers present in DBA and resin . Prior studies focused on salivary esterase for metabolism and degradation of resin monomers clinical ly . This study found that human dental pulp cells expressed mainly carboxylesterase-2 ( CES2 ) and smaller amounts of CES1A1 and CES3 isoforms . Exposure to BisGMA stimulated CES isoforms expression of pulp cells , and this event was inhibited by catalase . Exogenous addition of porcine esterase prevented BisGMA- and DBA-induced cytotoxicity . Interestingly , inhibition of CES by bis(p-nitrophenyl ) phosphate ( BNPP ) and CES2 by loperamide enhanced the cytotoxicity of BisGMA and DBA . Addition of porcine esterase or N-acetyl-l-cysteine prevented BisGMA-induced prostagl and in E(2 ) ( PGE(2 ) ) and PGF(2α ) production . In contrast , addition of BNPP and loperamide , but not mevastatin , enhanced BisGMA-induced PGE(2 ) and PGF(2α ) production in dental pulp cells . These results suggest that BisGMA may induce the cytotoxicity and prostanoid production of pulp cells , leading to pulpal inflammation or necrosis via reactive oxygen species production . Expression of CES , especially CES2 , in dental pulp cells can be an adaptive response to protect dental pulp against BisGMA-induced cytotoxicity and prostanoid release . Resin monomers are the main toxic components in DBA , and the ester group is crucial for monomer toxicity",
"Apical periodontitis ( AP ) are frequent findings in contemporary dental practice in association with dental pathology or dental care . They have also been studied from an anthropological background . The purpose of this study was to compare the prevalence of apical and dental lesions in an archeological Middle Ages sample and a modern population , and to evaluate the influence of environmental factors . Both the archaeological sample group and dental practice subjects were from southern France . The study included full mouth surveys of 252 individuals ( 2,780 teeth ) from a historic necropolis and 223 subjects ( 5,678 teeth ) r and omly selected from the Gard area . Tooth wear , caries , and AP were accounted for clinical ly and radiographically according to specific indexes . Significant differences were found between period and age in the archeological sample as regards the main risk factors for AP . Antemortem teeth loss and dental wear had been reduced , whereas caries rates and AP had increased between archaeological and modern population . The AP ratio was associated with the level of dental care in the modern population . Although significant variations could be observed between archaeological periods , the rupture in E3 ( sixteenth and seventeenth centuries ) leads to consider the associated population as a premodern . However , it was found that although cultural and alimentary factors seemed to be the main risk factors in an archeological population , dental care seemed to have a strong influence on AP ratio in modern ones",
"AIM To identify and describe individual and tooth-specific factors associated with the incidence or the persistence of apical periodontitis ( AP ) in a general population . METHODOLOGY In 1997 , 616 r and omly selected individuals had a full-mouth radiographic survey . In 2003 , 77 % of the participants returned for a new full-mouth radiographic examination . All teeth were assessed individually and data recorded for caries , marginal bone level , and tooth restorations . Multiple logistic regression analyses were performed to identify predictors of AP in the individual . Conditional logistic regression analyses were used to identify risk factors for development of AP in a tooth . Independent variables included a number of individual and tooth-specific variables . RESULTS Root fillings , coronal restorations , primary carious lesions , and reduced marginal bone level were associated with the incidence of AP in the individual . In teeth , the quality and presence of a coronal restoration was associated with the incidence of AP , and presence of a root filling also increased the risk of developing AP . Furthermore , an increased risk of developing AP was seen in relation to primary carious lesions , reduced marginal bone level , and molar teeth . The quality of the root filling was not associated with the incidence of AP , but the results suggest an association between the quality of the root filling and the healing of AP . CONCLUSIONS Results from the present study demonstrate that it is important to provide high quality dental restorations to minimize the risk of pulpal infection . The clinical focus , in relation to the incidence of AP , should be on improving the quality of the coronal restoration . The quality of a root filling was not associated with the incidence of AP , but may be of importance in relation to healing of AP",
"The aim of this epidemiological study was to analyse various clinical and radiographic data on oral health and compare the results to those of two cross-sectional studies carried out in 1973 and 1983 . In 1973 , 1983 , and 1993 a r and om sample of 1000 , 1104 , and 1078 individuals , respectively were studied . The individuals were evenly distributed in the age groups 3 , 5 , 10 , 15 , 20 , 30 , 40 , 50 , 60 , and 70 years . In 1983 and 1993 80-year-olds were also included . All subjects were inhabitants of the community of Jönköping , Sweden . The clinical and radiographic examination assessed edentulousness , removable dentures , implants , number of teeth , caries , restorations and overhangs , oral hygiene , calculus , periodontal status , endodontic treatment , and periapical status . The number of edentulous individuals was reduced by half from 1973 to 1993 and is now 8 % in the age groups 40 - 70 years . The mean number of teeth has increased and up to the age of 50 years the individuals had more or less complete dentitions . During the 20-year period there was generally decreasing number of carious lesions and restorations . In the 15- and 20-year-olds , however , there was an increasing number of decayed/filled tooth surfaces in 1993 compared to 1983 . Furthermore , after the age of 50 there was an increase in number of restored tooth surfaces . As regards secondary caries there was an increase for the 10- and 15-year-olds between 1983 and 1993 . For all other age groups there were only minor differences . Generally restorations exhibited a high quality and 85 - 90 % had no proximal overhangs . In 1973 this figure was about 60 % . Concerning the frequency of tooth surfaces exhibiting plaque and gingival inflammation there was a considerable decrease from 1973 to 1983 , but during the period from 1983 to 1993 there seems to be no improvement . In some age groups there was even a significant increase in plaque ( 15-year-olds ) and gingivitis ( 3- , 5- , 15- , 20- , and 60-year-olds ) . The frequency of individuals with one or more periodontal pockets ( > 4 mm ) increased with age . In 1993 the bone level at the age of 40 years corresponded to the bone level at the age of 20 years in 1973 . The percentage of endodontically treated teeth was lower in 1993 in all age groups than in 1973 and 1983 . The percentage of endodontically treated teeth with periapical or juxtaradicular destructions was unchanged in all three studies . The comparison of the three studies from 1973 , 1983 , and 1993 shows that there has been a great improvement in oral health over this 20-year period . In 1993 , however , the increasing number of decayed/filled tooth surfaces in the 15- and 20-year-olds and an increase in plaque and gingivitis in some younger age groups calls for special attention",
"OBJECTIVE The aim of this study was to evaluate the morphology of the resin-dentin interface formed in vivo with two posterior resin composite placement techniques ( incremental and bulk ) . METHOD AND MATERIAL S After approval from the patients , 12 Class II cavities with margins in enamel ( 2.5 x 2.5 x 4.5 mm ) were prepared in caries-free premolars scheduled to be extracted for orthodontic reasons ( n = 6 ) . The cavities were restored with Single Bond + Filtek P60 as a bulk condensable technique or Single Bond + Filtek Z250 as an oblique incremental technique . After 1 week , the teeth were extracted with minimal trauma to the restored area . After the teeth were sectioned , a polyvinyl siloxane impression was taken from the resin-dentin interface to control for artifacts created during preparation for scanning electron microscopy . The specimens were subsequently processed for and observed under a scanning electron microscope to assess gap formation . RESULTS The mean percentage of gap formation was 6.1 % for teeth restored with the incremental placement technique and 18.7 % for teeth restored with the bulk placement technique . The difference was statistically significant . CONCLUSION The incremental placement of posterior resin composites may still provide better seal than the new bulk condensable technique",
"AIM To test the hypothesis that dentine and pulp protection by conditioning- and -sealing is no less effective than using a conventional calcium hydroxide lining . METHODOLOGY A cohort of healthy adults requiring a new or replacement restoration in a posterior tooth was recruited in six general practice s. All procedures received local Ethics Committee approval . Exclusion criteria included signs and symptoms of pulp necrosis or inflammation , and patients unable to commit to a long-term trial . Cavity preparations were r and omized to receive a calcium hydroxide lining or conditioning- and -sealing with a smear-removing bonding system . Choice of bulk restorative material ( composite resin or amalgam ) was at the discretion of the dentist . The key outcome measure was evidence of pulpal breakdown identified at unscheduled ( emergency ) or scheduled recall examinations . Postoperative sensitivity was recorded on 100 mm VAS at 24 h , 4 days and 7 days . Pulp status was assessed at 6 , 12 , 24 and 36 month recall , and at any emergency recall appointment . The relationship between pre-treatment and treatment variables and pulp breakdown was assessed by logistic regression ( P = 0.05 ) . RESULTS A total of 602 teeth were recruited , with comparable numbers of cavities lined ( 288 , 47.8 % ) or conditioned and sealed ( 314 , 52.2 % ) . The majority ( 492 , 81.7 % ) were replacement restorations , and amalgam was the most common bulk restorative material ( 377 , 62.6 % ) . A total of 390 ( 64.8 % ) restored teeth were review ed at 6 months , 307 ( 51 % ) at 12 months , 363 ( 60.3 % ) at 24 months , and 279 ( 46.3 % ) at 36 months post-restoration . Sixteen cases of pulp breakdown were identified within 36 months of restoration placement , 11 presenting as emergencies and five detected at routine recall examination . Logistic regression showed that preoperative pain , cavity treatment by lining or conditioning- and -sealing and the use of rubber dam isolation had no association with pulp breakdown . Pulp breakdown was associated with deep or pulpally exposed cavities ( P pulpal exposure was the key determinant of adverse pulp outcomes ( P composite resin restorations were again more likely to be associated with pulp breakdown than amalgam ( P = 0.017 , odds ratio 3.92 ) . CONCLUSIONS Considered within the context of routine primary dental care : Dentists can be confident that pulps will be equally well protected from post-restorative breakdown up to 36 months by calcium hydroxide lining and conditioning- and -sealing with adhesive resins . Residual dentine thickness appears to be a key determinant of pulp responses after restorative dental treatment . In deep and pulpally exposed cavities in posterior teeth , composites were associated with more pulpal breakdown than amalgams",
"Using modified USPHS criteria , we evaluated annually for ten years 91 cases restored with visible light cured posterior composite resin LFP ( Base resin : UDMA ; filler : micro crushed type , alumino-silicate , barium glass and silica , 85 wt% , 74 vol% ) . The 91 cases restored with LFP decreased to 68 in ten years . Of the 23 cases that were lost , one result ed from a pulpal reaction immediately following restoration , four were extracted owing to periodontal disease or extrusion of third molars , two became abutments owing to loss of an adjacent tooth , eight had recurrent caries , and eight were lost owing to caries on a surface having no relationship to the composite resin restoration . Because we observed comparatively little wear , good marginal adaptability , and no discoloration , we concluded that the ten-year clinical success of LFP was on the whole very good , and that this resin has adequate clinical merit as a restorative material for posterior teeth when restricted to restorations covering comparatively small areas",
"PURPOSE The aim of this clinical study was to observe the service duration of porcelain laminate veneers ( PLVs ) and to estimate the influence of the categorical covariates such as location , tooth vitality , preparation depth , incisal , gingival and proximal finishing lines , and peripheral tissue type on the survival rates of event-free and overall service duration . MATERIAL S AND METHODS A total of forty patients ( 26 women , 14 men ; age range : 16 to 50 ) who had received 200 PLVs were evaluated in this study . Median follow-up time was 67.25 weeks with a range of 12 to 72 weeks . Fifteen of the restored teeth were nonvital , while the remaining 185 were vital . Categorical covariates related to the restoration design ( localization , vitality , preparation depth , incisal , proximal , and gingival finishings , and surrounding tissue type ) were recorded in order to estimate their influence on the survival rates . Survival rates of the event-free and overall service duration were calculated with the Kaplan-Meier analysis and Mantel log rank test . RESULTS Twelve failures were observed . The most frequent failure type ( 11 units ) was debonding of the restoration from the abutment tooth . Nine of them were rebonded and the remaining 2 were remade with a different preparation design . The last failure was observed as a coronal fracture at the cervical level . The overall survival rates were 99.5 % , 99 % , 97.5 % , 94.9 % , 94.4 % and 93.8 % at weeks 8 , 9 , 11 , 15 , 16 , and 34 , respectively , with a mean estimate of 68.45 weeks . CONCLUSION PLVs exhibited good clinical results with their conservative specifications and high survival rates . The preparation and design specifications affect the service duration of PLVs",
"This case-control study sought to identify variables predictive of subsequent root canal therapy ( RCT ) in teeth receiving full coverage restorations . The University of North Carolina School of Dentistry 's computerized treatment data base was used to identify all patients receiving a single-unit crown on a nonendodontically treated permanent tooth from January 1 , 1998 through December 31 , 2002 . These patients then were classified either as cases ( those whose crowned teeth received RCT before July 1 , 2004 ) or controls ( those whose crowned teeth did not ) . Computerized data , chart entries , and dental radiographs were examined to determine pre- , intra- , and postoperative factors of interest . In the final multivariable logistic regression model that included 66 cases and 71 controls , younger age ( p = 0.005 ) and greater extent of coronal and root destruction ( p = 0.020 ) remained statistically significant predictors of case status , though many potentially important predictors were unavailable through chart review . Patients could benefit if prospect i ve studies were conducted to identify factors predictive of subsequent endodontic involvement in newly crowned teeth",
"STATEMENT OF PROBLEM There are only a few studies available that deal with the clinical behavior of composite and ceramic inlay systems as potential substitutes for amalgam restorations . PURPOSE This prospect i ve clinical trial evaluated composite and ceramic inlay systems for clinical acceptability as restorative material s in single or multisurface cavities of posterior teeth and provided 1-year results . MATERIAL AND METHODS Forty-seven composite inlays ( Tetric , Blend-a-lux , Pertac ) and 24 heat-pressed ceramic inlays ( IPS Empress ) were placed in 45 patients by 7 student operators under the supervision of an experienced dentist . The first clinical evaluation was performed 11 to 13 months after placement of the restorations and used modified United States Public Health Services criteria . RESULTS Satisfactory results over this period were found , as 100 % of ceramic inlays and 94 % of composite inlays were assessed to be clinical ly excellent and acceptable . Only 3 composite inlay restorations were scored delta ( unacceptable ) . Two inlays exhibited secondary caries and 1 demonstrated loss of pulp vitality . For the criteria \" anatomic form of the surface \" and \" marginal integrity , \" ceramic inlays were significantly better than composite inlays . CONCLUSION Posterior tooth-colored inlays provided acceptable and excellent clinical service , even if they are placed by relatively inexperienced student operators"
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4117f4b0-06ff-11f0-808a-c43d1ab1c353
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Purpose The aim of the current meta- analysis was to investigate the effect of increasing dietary ALA intake on the blood concentration of inflammatory markers including tumor necrosis factor ( TNF ) , interleukin 6 ( IL-6 ) , C-reactive protein ( CRP ) , soluble intercellular adhesion molecule-1 ( sICAM-1 ) , and soluble vascular cell adhesion molecule-1 ( sVCAM-1 ) in adults . Methods After a systemic search on PubMed , Embase , and Cochrane library and bibliographies of relevant articles , 25 r and omized controlled trials that met the inclusion criteria were identified . Results No significant effect of dietary ALA supplementation was observed on TNF ( SMD : −0.03 , 95 % CI −0.36 to 0.29 ) , IL-6 ( SMD : −0.17 , 95 % CI −0.46 to 0.12 ) , CRP ( SMD : −0.06 , 95 % CI −0.24 to 0.12 ) , sICAM-1 ( SMD : −0.06 , 95 % CI −0.26 to 0.13 ) , and sVCAM-1 ( SMD : −0.24 , 95 % CI −0.56 to 0.09 ) . Subgroup analysis revealed that increasing dietary ALA tends to elevate CRP concentration in healthy subjects . However , the None effect of ALA supplementation on other inflammatory markers was not changed in various subgroups , indicating that the results are stable . Meta-regression results revealed a negative relationship between the effect size on CRP and its baseline concentration . No significant publication bias was observed for all inflammatory markers as suggested by funnel plot and Begg ’s test . Conclusion Our meta- analysis did not find any beneficial effect of ALA supplementation on reducing inflammatory markers including TNF , IL-6 , CRP , sICAM-1 , and sVCAM-1 . However , in healthy subjects , ALA supplementation might increase CRP concentration
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"Recently , novel dietary oils with modified fatty acid profiles have been manufactured to improve fatty acid intakes and reduce CVD risk . Our objective was to evaluate the efficacy of novel high-oleic rapeseed ( canola ) oil ( HOCO ) , alone or blended with flaxseed oil ( FXCO ) , on circulating lipids and inflammatory biomarkers v. a typical Western diet ( WD ) . Using a r and omised , controlled , crossover trial , thirty-six hypercholesterolaemic subjects consumed three isoenergetic diets for 28 d each containing approximately 36 % energy from fat , of which 70 % was provided by HOCO , FXCO or WD . Dietary fat content of SFA , MUFA , PUFA n-6 and n-3 was 6 , 23 , 5 , 1 % energy for HOCO ; 6 , 16 , 5 , 7·5 % energy for FXCO ; 11·5 , 16 , 6 , 0·5 % energy for WD . After 28 d , compared with WD , LDL-cholesterol was reduced 15·1 % ( P ) with FXCO and 7·4 % ( P with HOCO . Total cholesterol ( TC ) was reduced 11 % ( P with FXCO and 3·5 % ( P = 0·002 ) with HOCO compared with WD . Endpoint TC differed between FXCO and HOCO ( P 0·05 ) . FXCO consumption reduced HDL-cholesterol by 8·5 % ( P 0·001 ) and LDL : HDL ratio by 7·5 % ( P = 0·008 ) v. WD . FXCO significantly decreased E-selectin concentration compared with WD ( P = 0·02 ) . No differences were observed in inflammatory markers after the consumption of HOCO compared with WD . In conclusion , consumption of novel HOCO alone or when blended with flaxseed oil is cardioprotective through lipid-lowering effects . The incorporation of flaxseed oil may also target inflammation by reducing plasma E-selectin ",
"BACKGROUND There is conflicting evidence on the benefits of foods rich in vitamin E ( alpha-tocopherol ) , n-3 polyunsaturated fatty acids ( PUFA ) , and their pharmacological substitutes . We investigated the effects of these substances as supplements in patients who had myocardial infa rct ion . METHODS From October , 1993 , to September , 1995 , 11,324 patients surviving recent ( were r and omly assigned supplements of n-3 PUFA ( 1 g daily , n=2836 ) , vitamin E ( 300 mg daily , n=2830 ) , both ( n=2830 ) , or none ( control , n=2828 ) for 3.5 years . The primary combined efficacy endpoint was death , non-fatal myocardial infa rct ion , and stroke . Intention-to-treat analyses were done according to a factorial design ( two-way ) and by treatment group ( four-way ) . FINDINGS Treatment with n-3 PUFA , but not vitamin E , significantly lowered the risk of the primary endpoint ( relative-risk decrease 10 % [ 95 % CI 1 - 18 ] by two-way analysis , 15 % [ 2 - 26 ] by four-way analysis ) . Benefit was attributable to a decrease in the risk of death ( 14 % [ 3 - 24 ] two-way , 20 % [ 6 - 33 ] four-way ) and cardiovascular death ( 17 % [ 3 - 29 ] two-way , 30 % [ 13 - 44 ] four-way ) . The effect of the combined treatment was similar to that for n-3 PUFA for the primary endpoint ( 14 % [ 1 - 26 ] ) and for fatal events ( 20 % [ 5 - 33 ] ) . INTERPRETATION Dietary supplementation with n-3 PUFA led to a clinical ly important and statistically significant benefit . Vitamin E had no benefit . Its effects on fatal cardiovascular events require further exploration",
"BACKGROUND Since inflammation is believed to have a role in the pathogenesis of cardiovascular events , measurement of markers of inflammation has been proposed as a method to improve the prediction of the risk of these events . METHODS We conducted a prospect i ve , nested case-control study among 28,263 apparently healthy postmenopausal women over a mean follow-up period of three years to assess the risk of cardiovascular events associated with base-line levels of markers of inflammation . The markers included high-sensitivity C-reactive protein ( hs-CRP ) , serum amyloid A , interleukin-6 , and soluble intercellular adhesion molecule type 1 ( sICAM-1 ) . We also studied homocysteine and a variety of lipid and lipoprotein measurements . Cardiovascular events were defined as death from coronary heart disease , nonfatal myocardial infa rct ion or stroke , or the need for coronary-revascularization procedures . RESULTS Of the 12 markers measured , hs-CRP was the strongest univariate predictor of the risk of cardiovascular events ; the relative risk of events for women in the highest as compared with the lowest quartile for this marker was 4.4 ( 95 percent confidence interval , 2.2 to 8.9 ) . Other markers significantly associated with the risk of cardiovascular events were serum amyloid A ( relative risk for the highest as compared with the lowest quartile , 3.0 ) , sICAM-1 ( 2.6 ) , interleukin-6 ( 2.2 ) , homocysteine ( 2.0 ) , total cholesterol ( 2.4 ) , LDL cholesterol ( 2.4 ) , apolipoprotein B-100 ( 3.4 ) , HDL cholesterol ( 0.3 ) , and the ratio of total cholesterol to HDL cholesterol ( 3.4 ) . Prediction models that incorporated markers of inflammation in addition to lipids were significantly better at predicting risk than models based on lipid levels alone ( P levels of hs-CRP and serum amyloid A were significant predictors of risk even in the subgroup of women with LDL cholesterol levels below 130 mg per deciliter ( 3.4 mmol per liter ) , the target for primary prevention established by the National Cholesterol Education Program . In multivariate analyses , the only plasma markers that independently predicted risk were hs-CRP ( relative risk for the highest as compared with the lowest quartile , 1.5 ; 95 percent confidence interval , 1.1 to 2.1 ) and the ratio of total cholesterol to HDL cholesterol ( relative risk , 1.4 ; 95 percent confidence interval , 1.1 to 1.9 ) . CONCLUSIONS The addition of the measurement of C-reactive protein to screening based on lipid levels may provide an improved method of identifying persons at risk for cardiovascular events",
"Malnutrition and chronic inflammation in dialysis patients negatively impact their survival prognosis , and nutrients , such as omega-3 oils , are postulated to reduce proinflammatory response . In this r and omized , double-blind , multicenter , placebo-controlled trial , we investigated the effects of flaxseed oil ( FO ) on the inflammatory state of patients with chronic renal failure undergoing renal replacement therapy with hemodialysis ( HD ) . We hypothesized that FO supplementation lowers C-reactive protein ( CRP ) levels . One hundred sixty patients with chronic renal failure who received HD therapy of 3 dialysis units over a 3-month period in South Brazil were included . The patients received blind doses of FO ( 1 g twice a day ) and placebo ( mineral oil , 1 g twice a day ) for a period of 120 days . Inflammation was observed in 89 patients ( 61 % ) at the beginning of the study . There was a correlation between CRP and the body mass index ( R(s ) = 0.22 ; P = .022 ) and high-density lipoprotein cholesterol ( R(s ) = -0.23 ; P = .032 ) , and the CRP levels decreased significantly over time in the group that received FO compared with the control group ( P inflamed to a not-inflamed category , whereas only 16.9 % changed in the mineral oil group ( P = .04 ) . We conclude that the administration of FO decreases the CRP levels and that inflammation in HD patients appears to be correlated to their body mass index and reduced high-density lipoprotein cholesterol levels . Studies with a larger number of patients and over a longer duration are necessary to corroborate these findings",
"Greatly increasing the amounts of flaxseed oil [ rich in α-linolenic acid ( ALNA ) ] or fish oil ( FO ) ; [ rich in eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) ] in the diet can decrease inflammatory cell functions and so might impair host defense . The objective of this study was to determine the effect of dietary supplementation with moderate levels of ALNA , γ-linolenic acid ( GLA ) , arachidonic acid ( ARA ) , DHA , or FO on inflammatory cell numbers and functions and on circulating levels of soluble adhesion molecules . Healthy subjects aged 55 to 75 yr consumed nine capsules per day for 12 wk . The capsules contained placebo oil ( an 80∶20 mix of palm and sunflowerseed oils ) or blends of placebo oil with oils rich in ALNA , GLA , ARA , or DHA or FO . Subjects in these groups consumed 2 g ALNA ; approximately 700 mg GLA , ARA , or DHA ; or 1 g EPA plus DHA ( 720 mg EPA+280 mg DHA ) daily from the capsules . Total fat intake from the capsules was 4 g per day . None of the treatments affected inflammatory cell numbers in the bloodstream ; neutrophil and monocyte phagocytosis or respiratory burst in response to E. coli ; production of tumor necrosis factor-α , interleukin-1β , and interleukin-6 in response to bacterial lipopolysaccharide ; or plasma concentrations of soluble intercellular adhesion molecule-1 . In contrast , the ALNA and FO treatments decreased the plasma concentrations of soluble vascular cell adhesion molecule-1 ( 16 and 28 % decrease , respectively ) and soluble E-selectin ( 23 and 17 % decrease , respectively ) . It is concluded that , in contrast to previous reports using higher amounts of these fatty acids , a moderate increase in consumption of long-chain n−6 or n−3 polyunsaturated fatty acids does not significantly affect inflammatory cell numbers or neutrophil and monocyte responses in humans and so would not be expected to cause immune impairment . Furthermore , we conclude that moderate levels of ALNA and FO , which could be incorporated into the diet , can decrease some markers of endothelial activation and that this mechanism of action may contribute to the reported health benefits of n−3 fatty acids",
"BACKGROUND Greatly increasing dietary flaxseed oil [ rich in the n-3 polyunsaturated fatty acid ( PUFA ) alpha-linolenic acid ( ALA ) ] or fish oil [ rich in the long-chain n-3 PUFAs eicosapentaenoic ( EPA ) and docosahexaenoic ( DHA ) acids ] can reduce markers of immune cell function . The effects of more modest doses are unclear , and it is not known whether ALA has the same effects as its long-chain derivatives . OBJECTIVE The objective was to determine the effects of enriching the diet with ALA or EPA+DHA on immune outcomes representing key functions of human neutrophils , monocytes , and lymphocytes . DESIGN In a placebo-controlled , double-blind , parallel study , 150 healthy men and women aged 25 - 72 y were r and omly assigned to 1 of 5 interventions : placebo ( no additional n-3 PUFAs ) , 4.5 or 9.5 g ALA/d , and 0.77 or 1.7 g EPA+DHA/d for 6 mo . The n-3 PUFAs were provided in 25 g fat spread plus 3 oil capsules . Blood sample s were taken at 0 , 3 , and 6 mo . RESULTS The fatty acid composition of peripheral blood mononuclear cell phospholipids was significantly different in the groups with higher intakes of ALA or EPA+DHA . The interventions did not alter the percentages of neutrophils or monocytes engaged in phagocytosis of Escherichia coli or in phagocytic activity , the percentages of neutrophils or monocytes undergoing oxidative burst in response to E. coli or phorbol ester , the proliferation of lymphocytes in response to a T cell mitogen , the production of numerous cytokines by monocytes and lymphocytes , or the in vivo delayed-type hypersensitivity response . CONCLUSION An intake of ALA/d or EPA+DHA/d does not alter the functional activity of neutrophils , monocytes , or lymphocytes , but it changes the fatty acid composition of mononuclear cells",
"BACKGROUND Atherosclerosis is a chronic inflammatory disease . We previously reported that a diet high in alpha-linolenic acid ( ALA ) reduces lipid and inflammatory cardiovascular disease risk factors in hypercholesterolemic subjects . OBJECTIVE The objective was to evaluate the effects of a diet high in ALA on serum proinflammatory cytokine concentrations and cytokine production by cultured peripheral blood mononuclear cells ( P BMC s ) from subjects fed the experimental diets . DESIGN A r and omized , controlled , 3-diet , 3-period crossover study design was used . Hypercholesterolemic subjects ( n = 23 ) were assigned to 3 experimental diets : a diet high in ALA ( ALA diet ; 6.5 % of energy ) , a diet high in linoleic acid ( LA diet ; 12.6 % of energy ) , and an average American diet ( AAD ) for 6 wk . Serum interleukin (IL)-6 , IL-1beta , and tumor necrosis factor-alpha ( TNF-alpha ) concentrations and the production of IL-6 , IL-1beta , and TNF-alpha by P BMC s were measured . RESULTS IL-6 , IL-1beta , and TNF-alpha production by P BMC s and serum TNF-alpha concentrations were lower ( P ALA diet than with the LA diet or AAD . P BMC production of TNF-alpha was inversely correlated with ALA ( r = -0.402 , P = 0.07 ) and with eicosapentaenoic acid ( r = -0.476 , P = 0.03 ) concentrations in P BMC lipids with the ALA diet . Changes in serum ALA were inversely correlated with changes in TNF-alpha produced by P BMC s ( r = -0.423 , P antiinflammatory effects by inhibiting IL-6 , IL-1beta , and TNF-alpha production in cultured P BMC s. Changes in P BMC ALA and eicosapentaenoic acid ( derived from dietary ALA ) are associated with beneficial changes in TNF-alpha release . Thus , the cardioprotective effects of ALA are mediated in part by a reduction in the production of inflammatory cytokines",
"Background Recent evidence has demonstrated that the G0/G1 switch gene 2 ( G0S2 ) is an important negative regulator of the rate-limiting lipolytic enzyme adipose triglyceride lipase-mediated lipolysis . It has been revealed that α-linolenic acid ( ALA ) , a plant-based essential omega-3 polyunsaturated fatty acids , reduces adipose tissue lipolysis . However , it is not known whether G0S2 is implicated in ALA-induced inhibition of lipolysis . The purpose of this pilot study is to investigate the effect of ALA on G0S2 gene expression in peripheral blood mononuclear cells ( P BMC ) of obese patients and the potential influence of G0S2 gene expression in ALA-induced inhibition of lipolysis . Methods A total of 26 obese patients were r and omly assigned to be treated with or without ALA treatment ( ~4.0 g daily ) for 12 weeks : the ALA-treated group ( n = 14 ) or the untreated control group ( n = 12 ) . Plasma triglyceride ( TG ) , free fatty acids ( FFA ) , glycerol , interleukin-6 ( IL-6 ) and tumor necrosis factor-α ( TNF-α ) , as well as the mRNA expression levels of proliferator-activated receptor gamma ( PPAR-γ ) , G0S2 , and G protein-coupled receptor 120 ( GPR120 ) in P BMC were repeatedly examined from fasting obese patients before and after ALA treatment . Results ALA significantly decreased plasma TG , FFA , glycerol , IL-6 , and TNF-α levels and increased the mRNA expression levels of PPAR-γ , G0S2 , and GPR120 in P BMC , compared with the untreated control group . In obese patients from the ALA-treated group , decreased plasma FFA ( a biomarker for lipolysis ) level was significantly correlated with increased PPAR-γ ( a functional omega-3 fatty acids receptor ) and G0S2 ( a direct target gene of PPAR-γ ) mRNA expression in P BMC , while decreased plasma FFA level was not correlated with increased GPR120 ( another functional omega-3 fatty acids receptor ) mRNA expression in P BMC . Conclusion This study shows that ALA increases G0S2 gene expression in P BMC in parallel with the decrease of plasma FFA level in obese patients . Increased G0S2 gene expression might contribute to the beneficial anti-lipolytic effect of ALA in obese patients",
"Purpose The aim of this study was to investigate the effects of flaxseed oil consumption on serum systemic and vascular inflammation markers , and oxidative stress in hemodialysis ( HD ) patients . Methods In this r and omized , double-blind , clinical trial , 34 HD patients were r and omly assigned to either the flaxseed oil or the control group . The patients in the flaxseed oil group received 6 g/day flaxseed oil for 8 week , whereas the control group received 6 g/day medium-chain triglycerides ( MCT ) oil . At baseline and the end of week 8 , serum concentrations of high-sensitive C-reactive protein ( hs-CRP ) , soluble intercellular adhesion molecule type 1 ( sICAM-1 ) , soluble vascular cell adhesion molecule type 1 ( sVCAM-1 ) , sE-selectin , and malondialdehyde ( MDA ) were measured after a 12- to 14-h fast . Results Serum hs-CRP , a systemic inflammation marker , and sVCAM-1 , a vascular inflammation marker , reduced significantly in the flaxseed oil group at the end of week 8 compared to baseline ( P MCT oil group ( P changes in serum sICAM-1 , sE-selectin , and MDA . Conclusion This study indicates that daily consumption of 6 g flaxseed oil reduces serum hs-CRP and sVCAM-1 , which are two risk factors for CVD . Therefore , the inclusion of flaxseed oil in the usual diet of HD patients can be considered as a strategy for reducing CVD risk factors",
" Abstract Grape seed oil ( GSO ) is reported to improve oxidative stress and lipid profile . However , the ameliorating effect of GSO on inflammation and insulin resistance has not being noticed so far . We aim ed to examine the effects of GSO consumption on inflammation and insulin resistance in overweight or obese females . The subjects ( n = 44 ) were r and omly assigned into intervention group as “ GSO ” ( consuming 15 % of energy from GSO ) and control group as sunflower oil “ SFO ” ( consuming 15 % of energy from SFO ) through a weight loss diet for 8 weeks . Anthropometric measurements , dietary recall and fasting serum glucose , insulin , high sensitive C-reactive protein ( hs-CRP ) and tumor necrosis factor-alpha ( TNF-α ) were assessed before and after the intervention . Homeostatic model assessment of insulin resistance ( HOMA-IR ) scores , hs-CRP and TNF-α decreased in the GSO group . The hs-CRP was lower in GSO than the SFO group ( p ) . GSO consumption seems to improve inflammatory condition and insulin resistance in overweight/obese women",
"We investigated the antihypertensive effect and safety of alpha-linolenic acid ( ALA ) in human subjects . In Experiment 1 , subjects with high-normal blood pressure and mild hypertension ingested bread containing 14 g of common blended oil ( control oil ) or ALA-enriched oil for 12 weeks . The test oil contained 2.6g/14 g of ALA . The subjects ingested strictly controlled meals during the study period . Systolic blood pressure was significantly lower in the ALA group than in the control group after ingestion of the test diet for 4 , 8 and 12 weeks . Diastolic blood pressure was significantly lower in the ALA group than in the control group after ingestion of the test diet for 12 weeks . In Experiment 2 , we evaluated the safety of high intake of ALA ( 7.8 g/d ) , particularly its effects on oxidation in the body and blood coagulation . Normotensive , high-normotensive and mildly hypertensive subjects ate bread that contained 42 g of the control oil or the test oil for 4 weeks . No significant difference was noted in the lipid peroxide level , high-sensitive C-reactive protein level , plasma prothrombin time or activated partial thromboplastin time between the two groups . No abnormal changes were noted after test diet ingestion on blood test or urinalysis , and no adverse event considered to have been induced by the test oil was observed in Experiment 1 and 2 . These results suggest that ALA have an antihypertensive effect with no adverse effect in subjects with high-normal blood pressure and mild hypertension",
"Background —Visceral fat is a key regulator site for the process of inflammation , and atherosclerotic lesions are essentially an inflammatory response . Methods and Results —Fifty-six healthy premenopausal obese women ( age range 25 to 44 years , body mass index 37.2±2.2 , waist to hip ratio range 0.78 to 0.92 ) and 40 age-matched normal weight women were studied . Compared with nonobese women , obese women had increased basal concentrations of tumor necrosis factor-&agr ; ( TNF-&agr ; , P interleukin-6 ( IL-6 , P P-selectin ( P intercellular adhesion molecule-1 ( ICAM-1 , P vascular adhesion molecule-1 ( VCAM-1 , P ) . Vascular responses to l-arginine ( 3 g IV ) , the natural precursor of nitric oxide , were impaired in obese women : reductions in mean blood pressure ( P , platelet aggregation to adenosine diphosphate ( P , and blood viscosity ( P . Concentrations of TNF-&agr ; and IL-6 were related ( P multidisciplinary program of weight reduction ( diet , exercise , behavioral counseling ) , all obese women lost at least 10 % of their original weight ( 9.8±1.5 kg , range 7.5 to 13 kg ) . Compared with baseline , sustained weight loss was associated with reduction of cytokine ( P obese women , endothelial activation correlates with visceral body fat , possibly through inappropriate secretion of cytokines . Weight loss represents a safe method for downregulating the inflammatory state and ameliorating endothelial dysfunction in obese women",
"Dietary and endogenous fatty acids could play a role in low- grade inflammation . In this cross-sectional study the proportions of erythrocyte membrane fatty acids ( EMFA ) and the concentrations of C-reactive protein ( CRP ) , interleukin-1 receptor antagonist ( IL-1Ra ) and adiponectin were measured and their confounder-adjusted associations examined in 1373 r and omly selected Finnish men aged 45 - 70 years participating in the population based Metsim study in Eastern Finl and . The sum of n-6 EMFAs , without linoleic acid ( LA ) , was positively associated with concentrations of CRP and IL-1Ra ( r partial=0.139 and r partial=0.115 , P lean men ( waist circumference Total n-3 EMFAs correlated inversely with concentrations of CRP ( r partial=-0.098 , P CRP ( r partial=0.096 , P high concentrations of adiponectin ( r partial=0.139 , P inflammatory markers . Palmitoleic acid was associated with CRP , whereas , interestingly , its elongation product , cis-vaccenic acid , associated with anti-inflammatory adiponectin",
"Background Dietary alpha-linolenic acid ( ALA ) has been associated with reduced risk of development of atherosclerosis . Adiponectin is a hormone specifically secreted by adipocytes and considered to have anti-atherogenic properties . Aim of the study We examined the effect of increased dietary intake of ALA on plasma concentration of adiponectin . Methods Thirty-five non-diabetic , dyslipidemic men , 38–71 years old , were r and omly allocated to take either 15 ml of flaxseed oil rich in ALA ( 8.1 g/day ; n = 18 ) , or 15 ml of safflower oil per day , containing the equivalent n-6 fatty acid ( 11.2 g/day linoleic acid , LA ; n = 17 ) ( control group ) . The intervention period lasted for 12 weeks . Results Plasma levels of adiponectin did not change after the increase in dietary intake of ALA in the flaxseed oil supplementation group , compared to the control group . No changes in body mass index , serum lipid concentrations , LDL density , or plasma TNF-α were found in the flaxseed oil versus the control group . Conclusions Dietary ALA has no effect on plasma adiponectin concentration in dyslipidemic men",
"BACKGROUND Inflammation plays an important role in the pathogenesis of coronary artery disease . We examined whether dietary supplementation with alpha-linolenic acid ( ALA , 18:3n-3 ) affects the levels of inflammatory markers in dyslipidaemic patients . METHODS We recruited 76 male dyslipidaemic patients ( mean age=51+/-8 years ) following a typical Greek diet . They were r and omly assigned either to 15 ml of linseed oil ( rich in ALA ) per day ( n=50 ) or to 15 ml of safflower oil ( rich in linoleic acid ( LA , 18:2n-6 ) ) per day ( n=26 ) . The ratio of n-6:n-3 in linseed oil supplemented group was 1.3:1 and in safflower oil supplemented group 13.2:1 . Dietary intervention lasted for 3 months . Blood lipids and C-reactive protein ( CRP ) , serum amyloid A ( SAA ) , and interleukin-6 ( IL-6 ) levels were determined prior and after intervention . CRP and SAA were measured by nephelometry and IL-6 by immunoassay . RESULTS Dietary supplementation with ALA decreased significantly CRP , SAA and IL-6 levels . The median decrease of CRP was 38 % ( 1.24 vs. 0.93 mg/l , P=0.0008 ) , of SAA 23.1 % ( 3.24 vs. 2.39 mg/l , P=0.0001 ) and of IL-6 10.5 % ( 2.18 vs. 1.7 pg/ml , P=0.01 ) . The decrease of inflammatory markers was independent of lipid changes . Dietary supplementation with LA did not affect significantly CRP , SAA and IL-6 concentrations but decreased cholesterol levels . CONCLUSIONS Dietary supplementation with ALA for 3 months decreases significantly CRP , SAA and IL-6 levels in dyslipidaemic patients . This anti-inflammatory effect may provide a possible additional mechanism for the beneficial effect of plant n-3 polyunsaturated fatty acids in primary and secondary prevention of coronary artery disease",
"Objective : To investigate the effects of increased alpha-linolenic acid (ALA)-intake on intima – media thickness ( IMT ) , oxidized low-density lipoprotein ( LDL ) antibodies , soluble intercellular adhesion molecule-1 ( sICAM-1 ) , C-reactive protein ( CRP ) , and interleukins 6 and 10 . Design : R and omized double-blind placebo-controlled trial . Subjects : Moderately hypercholesterolaemic men and women ( 55±10 y ) with two other cardiovascular risk factors (n=103).Intervention : Participants were assigned to a margarine enriched with ALA ( fatty acid composition 46 % LA , 15 % ALA ) or linoleic acid ( LA ) ( 58 % LA , 0.3 % ALA ) for 2 y. Results : Dietary ALA intake was 2.3 en% among ALA users , and 0.4 en% among LA users . The 2-y progression rate of the mean carotid IMT ( ALA and LA : + 0.05 mm ) and femoral IMT ( ALA:+0.05 mm ; LA:+0.04 mm ) was similar , when adjusted for confounding variables . After 1 and 2 y , ALA users had a lower CRP level than LA users ( net differences −0.53 and −0.56 mg/l , respectively , P in oxidized LDL antibodies , and levels of sICAM-1 , interleukins 6 and 10 . Conclusions : A six-fold increased ALA intake lowers CRP , when compared to a control diet high in LA . The present study found no effects on markers for atherosclerosis . Sponsorship : The Dutch ‘ Praeventiefonds ’",
"BACKGROUND Leukocyte adhesion and transendothelial migration , the critical pathogenic components in the development of atherosclerotic lesions , are largely mediated by cellular adhesion molecules ( CAMs ) . We examined whether dietary supplementation with alpha-linolenic acid ( ALA , 18:3n-3 ) affects the levels of soluble forms of CAMs in dyslipidaemic patients . METHODS We recruited 90 male dyslipidaemic patients ( mean age=51+/-8 years ) following a typical Greek diet . They were r and omly assigned either to 15 ml of linseed oil ( rich in ALA ) per day ( n=60 ) or to 15 ml of safflower oil ( rich in linoleic acid [ LA , 18:2n-6 ] ) per day ( n=30 ) . The ratio of n-6:n-3 in linseed oil supplemented group was 1.3:1 and in safflower oil supplemented group 13.2:1 . Dietary intervention lasted for 12 weeks . Blood lipids , soluble intercellular adhesion molecule-1 ( sICAM-1 ) , soluble vascular cell adhesion molecule-1 ( sVCAM-1 ) and soluble E-selectin ( sE-selectin ) were measured . RESULTS Dietary supplementation with ALA significantly decreased sVCAM-1 levels ( median decrease 18.7 % [ 577.5 ng/ml versus 487 ng/ml , P=0.0001 ] ) . In the LA supplemented group , sVCAM-1 was also significantly decreased but to a lesser extent ( median decrease 10.6 % [ 550.5 ng/ml versus 496 ng/ml , P=0.0001 ] ) . After controlling for smoking habits , no significant difference was observed in the reduction of sVCAM-1 levels between the two treatment arms ( P=0.205 ) . The decrease of sVCAM-1 was independent of lipid changes in both groups . CONCLUSIONS Dietary supplementation with ALA for 12 weeks significantly decreases sVCAM-1 levels in dyslipidaemic patients . This effect presents a potential mechanism for the beneficial effect of plant n-3 polyunsaturated fatty acids in the prevention of coronary artery disease . In addition , dietary supplementation with LA significantly decreases sVCAM-1 levels , an effect which requires further investigation",
"Increased inflammation with aging has been linked to sarcopenia . The purpose of this study was to evaluate the effects of supplementing older adults with alpha-linolenic acid ( ALA ) during a resistance training program , based on the hypothesis that ALA decreases the plasma concentration of the inflammatory cytokine tumor necrosis factor (TNF)-alpha and interleukin (IL)-6 , which in turn would improve muscle size and strength . Fifty-one older adults ( 65.4 + /- 0.8 years ) were r and omized to receive ALA in flax oil ( ~14 g.day-1 ) or placebo for 12 weeks while completing a resistance training program ( 3 days a week ) . Subjects were evaluated at baseline and after 12 weeks for muscle thickness of knee and elbow flexors and extensors ( B-mode ultrasound ) , muscle strength ( 1 repetition maximum ) , body composition ( dual energy X-ray absorptiometry ) , and concentrations of TNF-alpha and IL-6 . Males supplementing with ALA decreased IL-6 concentration over the 12 weeks ( 62 + /- 36 % decrease ; p = 0.003 ) , with no other changes in inflammatory cytokines . Chest and leg press strength , lean tissue mass , muscle thickness , hip bone mineral content and density , and total bone mineral content significantly increased , and percent fat and total body mass decreased with training ( p ALA being a significantly greater increase in knee flexor muscle thickness in males ( p Total-body bone mineral density improved in the placebo group , with no change in the ALA group ( p = 0.05 ) . ALA supplementation lowers the IL-6 concentration in older men but not women , but had minimal effect on muscle mass and strength during resistance training",
"Background heart failure is a major risk factor for cardiovascular mortality , for which n-3 fatty acids may have beneficial effects . We examined the effect of marine eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) , and plant-derived alpha-linolenic acid ( ALA ) on N-Terminal-pro Brain Natriuretic Peptide ( NT-proBNP ) , a biomarker of heart failure . Methods we r and omly assigned 4837 post-myocardial infa rct ion patients , aged 60–80 years ( 82 % men ) , to margarines supplemented with a targeted additional intake of 400 mg/day EPA and DHA , 2 g/day ALA , EPA-DHA plus ALA , or placebo for 40 months . In a r and om selection of 639 patients , NT-proBNP was determined both at baseline and at the end of follow-up . NT-proBNP was loge-transformed and analysed by type of treatment using analysis of covariance adjusting for baseline NT-proNBP . Results patients consumed on average 19.8 g margarine/day , providing an additional amount of 238 mg/day EPA with 158 mg/day DHA , 1.98 g/day ALA , or both , in the active-treatment groups . In the placebo group , the geometric mean level NT-proBNP increased from 245 ng/l ( 95%-confidence interval [ CI ] : 207–290 ) to 294 ng/l ( 95%-CI : 244–352 ) after 40 months ( p = 0.001 ) . NT-proBNP levels were not affected by ALA ( + 8 % versus placebo ; 95%-CI : −8 % to + 25 % ; p = 0.34 ) , EPA-DHA ( + 2 % versus placebo ; 95%-CI : −14 % to + 18 % ; p = 0.78 ) , nor EPA-DHA plus ALA ( + 9 % versus placebo ; 95%-CI : −8 % to + 25 % ; p = 0.31 ) treatment . Conclusions supplementation with modest amounts of EPA-DHA , with or without ALA , did not have a significant effect on NT-proBNP levels in patients with a history of myocardial infa rct ion",
"Various studies have already shown that the fatty acid composition of dietary fat has different effects on hemostasis and platelet function . However , knowledge on this topic is incomplete . In the present study , fifty-eight healthy students received either a 4-week rapeseed oil [ high content of monounsaturated fatty acids ( MUFA ) and high n-3/n-6 PUFA ratio ] , an olive oil ( high content of MUFA , low n-3/n-6 PUFA ratio ) or a sunflower oil ( low content of MUFA , low n-3/n-6 PUFA ratio ) diet . In each group , effects on hemostatic parameters were compared with a wash-in diet rich in saturated fatty acids with respect to intermediate-time effects on the hemostatic system and platelet function . With the olive oil diet , a reduction of coagulation factors VIIc , XIIc , XIIa , and Xc was found , whereas sunflower oil led to lower values of coagulation factors XIIc , XIIa , and IXc . In all study groups levels of plasmin-alpha2-antiplasmin were lower in week 4 than at baseline . Lower fibrinogen binding on platelets was found after the sunflower oil diet , whereas expression of CD62 and spontaneous platelet aggregation were slightly higher after the olive oil diet . However , given the major differences in the fatty acid compositions of the diets , the differences between the groups with respect to hemostasis tended to be small . Therefore , the clinical significance of the present findings remains to be evaluated",
"OBJECTIVE ω-3 Polyunsaturated α-linolenic acid ( ALA ) supplementation has not been studied in the setting of adiponectin levels and insulin sensitivity ( IS ) improvements in patients with type 2 diabetes mellitus ( T2DM ) by hyperinsulinemic-euglycemic clamp ( HEC ) . The aim of this study was to examine the influence of ω-3 ALA on IS and adiponectin . METHODS We conducted a r and omized study in patients with T2DM and assessed IS using HEC . Twenty patients with T2DM were included and r and omly assigned to receive 3 g/d of ALA or placebo for 60 d , in a double-blind design . The assessment of IS by HEC was performed at baseline and after 60 d in all patients ; blood sample s were taken for the measurement of serum lipids , glucose , insulin , adiponectin , and cytokines . The primary outcome variables were an increase of both glucose infusion rate ( GIR ) in steady state and glucose metabolization ( M ) by HEC . The secondary outcomes were an increase in adiponectin levels and a decrease in fasting plasma glucose , glycated hemoglobin , homeostasis model assessment -estimated insulin resistance ( HOMA-IR ) index , lipids and cytokines . The study was conducted at an academic medical center . RESULTS The ALA group improved IS corrected for fat-free mass ( M/FFM ; P = 0.04 ) . Both groups showed increased adiponectin after 60 d ( P = 0.01 ) , however , the increase for the ALA group was greater ( P = 0.04 ) . In the ALA group , adiponectin was positively correlated with GIR ( r = 0.76 ; P = 0.01 ) and M/FFM ( r = 0.62 ; P = 0.06 ) , and negatively correlated with HOMA-IR ( r = -0.61 ; P = 0.03 ) . CONCLUSION ω-3 ALA supplementation improved glucose homeostasis and was associated with an increase in adiponectin . Improvement in the overall metabolic profile with ω-3 ALA suggests a potential clinical utility for this agent and requires further investigation",
"OBJECTIVE Olive oil ( OO ) is a rich source of monounsaturated fat and bioactive components that exert strong anti-oxidant and anti-inflammatory properties . Flaxseed oil ( FO ) is rich in α-linolenic n-3 fatty acid ( ALA ) , which also exhibits anti-inflammatory effects . This r and omized , cross-over study aim ed at exploring whether diet 's enrichment with FO could beneficially alter inflammatory markers and lipid profile , compared to OO , in a sample of normal weight , apparently healthy young adults . MATERIAL S AND METHODS Participants were supplied with 15 mL/day of either FO or OO . Each intervention and the wash-out period lasted 6 weeks . Dietary , anthropometric and physical activity variables were recorded at the beginning and the end of each intervention . Serum biochemical and inflammatory markers were measured . Compliance to the intervention was evaluated by fatty acid analysis in erythrocytes . Repeated Measures ANOVA was used to assess the effect of the treatment . RESULTS Thirty seven participants completed the study . No difference between the two interventions was observed in adiponectin , TNF-α , high sensitivity-CRP or glucose levels and lipid profile . At the end of the FO period , participants exhibited significant reductions in total ( -5.0 % ) and LDL-cholesterol ( -6.7 % ) levels ( all P period serum adiponectin changes were significantly correlated with changes in erythrocyte % ALA ( rs=0.34 , P=0.007 ) and in erythrocyte % EPA ( r(s)=0.47 , P=0.01 ) , respectively . CONCLUSIONS Daily consumption of FO did not confer any benefit in inflammatory or biochemical markers in normal weight young adults , who traditionally use olive oil as the main edible oil",
"Objective : The impact of dietary polyunsaturated fatty acids ( PUFAs ) of the n-6 and n-3 series on the cardiovascular system is well documented . To directly compare the effects of three dietary oils ( fish , flaxseed and hempseed ) given in concentrations expected to be self-administered in the general population on specific cardiovascular parameters in healthy volunteers . Design : 86 healthy male and female volunteers completed a 12 week double blinded , placebo controlled , clinical trial . They were r and omly assigned to one of the four groups . Subjects were orally supplemented with two 1 gm capsules of placebo , fish oil , flaxseed oil or hempseed oil per day for 12 weeks . Results : Plasma levels of the n-3 fatty acids docosahexanoic acid and eicosapentanoic acid increased after 3 months supplementation with fish oil . Alpha linolenic acid concentrations increased transiently after flaxseed supplementation . However , supplementation with hempseed oil did not significantly alter the concentration of any plasma fatty acid . The lipid parameters ( TC , HDL-C , LDL-C and TG ) did not show any significant differences among the four groups . Oxidative modification of LDL showed no increase in lag time over the 12 wk period . None of the dietary interventions induced any significant change in collagen or thrombin stimulated platelet aggregation and no increase in the level of inflammatory markers was observed . Conclusion : From a consumer 's perspective , ingesting 2 capsules of any of these oils in an attempt to achieve cardiovascular health benefits may not provide the desired or expected result over a 3 month period",
"The pathology of type 2 diabetes mellitus ( DM ) often is associated with underlying states of conditioned zinc deficiency and chronic inflammation . Zinc and omega-3 polyunsaturated fatty acids each exhibit anti-inflammatory effects and may be of therapeutic benefit in the disease . The present r and omized , double-blind , placebo-controlled , 12-week trial was design ed to investigate the effects of zinc ( 40 mg/day ) and α-linolenic acid ( ALA ; 2 g/day flaxseed oil ) supplementation on markers of inflammation [ interleukin (IL)-1β , IL-6 , tumor necrosis factor (TNF)-α , C-reactive protein ( CRP ) ] and zinc transporter and metallothionein gene expression in 48 postmenopausal women with type 2 DM . No significant effects of zinc or ALA supplementation were observed on inflammatory marker concentrations or fold change in zinc transporter and metallothionein gene expression . Significant increases in plasma zinc concentrations were observed over time in the groups supplemented with zinc alone or combined with ALA ( P=.007 and P=.009 , respectively ) . An impact of zinc treatment on zinc transporter gene expression was found ; ZnT5 was positively correlated with Zip3 mRNA ( P the expression levels and CRP predicted the fold change of the ZnT5 , ZnT7 , Zip1 , Zip7 and Zip10 mRNA cluster ( P respectively ) . Fold change in the expression of metallothionein mRNA was predicted by TNF-α ( P=.022 ) . Associations among inflammatory cytokines and zinc transporter and metallothionein gene expression support an interrelationship between zinc homeostasis and inflammation in type 2 DM",
"Long-chain n-3 PUFA from fish oils are known to have anti-inflammatory effects . We evaluated the effect of alpha-linolenic acid ( ALA ) , precursor of n-3 fatty acids , on serum inflammatory markers and soluble cellular adhesion molecules ( sCAM ) of dyslipidaemic males , relative to their background diet . Participants were assigned to two groups , based upon food intake patterns : ( a ) twenty-one dyslipidaemic subjects who habitually ate a Mediterranean-Cretan-type diet ; ( b ) nineteen dyslipidaemic subjects who normally ate a Westernised Greek diet . All were supplemented with 8.1 g ALA/d for 12 weeks . We determined serum amyloid A ( SAA ) , C-reactive protein ( CRP ) , macrophage colony-stimulating factor ( MCSF ) , IL-6 , soluble vascular cell adhesion molecule-1 ( sVCAM-1 ) , soluble intercellular adhesion molecule-1 and soluble E-selectin concentrations at the beginning and the end of the ALA supplementation period . Serum baseline concentrations of inflammatory markers and sCAM were similar across the diet groups . Type of diet had a significant impact on the response of inflammatory markers to ALA supplementation . The Westernised Greek diet group showed a reduction in SAA ( P CRP ( P=0.002 ) , MCSF ( P=0.005 ) and IL-6 ( P=0.04 ) concentrations . The Mediterranean-Cretan-type background diet group showed a significant reduction only in MCSF concentrations ( P=0.003 ) . The sVCAM-1 concentrations were significantly reduced in both the Westernised Greek diet group ( P=0.001 ) and the Mediterranean-Cretan-type diet group ( P ALA supplementation lowered the serum concentrations of inflammatory markers more profoundly when the background diet was rich in saturated fatty acids and poor in MUFA"
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4117f4ec-06ff-11f0-808a-c43d1ab1c353
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Pioglitazone is one of thiazolidinedione derivatives , which stimulates nuclear peroxisome proliferator-activated receptor gamma and improves glucose and lipid metabolism and insulin sensitivity . A recent systematic review and meta- analysis showed that pioglitazone therapy was associated with a lower risk of major adverse cardiovascular events in patients with pre-diabetes and diabetes . Further , in a cohort study of patients with type 2 diabetes , pioglitazone therapy was associated with a statistically significant decrease in the risk of all-cause mortality . Despite these beneficial effects , the meta- analysis showed that pioglitazone therapy had higher risks of heart failure , bone fractures , edema and weight gain . To find out the efficacy and safety of the low-dose ( 7.5 mg/day ) pioglitazone therapy , we review ed the dose-response of pioglitazone on favorable effects and adverse effects due to pioglitazone , by search ing the reports on effects of daily dose of 7.5 mg and /or 15 mg and /or 30 mg of pioglitazone . The low-dose pioglitazone therapy may show the same degree of improvements in glucose and lipid metabolism , fatty liver , insulin resistance , and adiponectin as the st and ard- and high-dose pioglitazone therapy . Furthermore , the low-dose pioglitazone therapy may also show less adverse effects on weight gain , edema and heart failure as compared with the st and ard- and high-dose pioglitazone therapy
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[
"We monitored the change in plasma ANP and BNP levels ( as markers for left ventricular dysfunction ( LVD ) ) in DM2 patients treated with pioglitazone ( Pio ) for 4 weeks . Thirty DM2 patients with no sign of heart failure were treated with Pio ( 15 mg/day ) , and their plasma ANP ( normal levels BNP levels ( normal levels no drug-treatment group ( n = 10 ) as well as buformine treatment group ( n = 10 ) . Among these groups , there were no significant differences in clinical profiles related to DM control . Pio treatment was terminated when BNP ( above 100 pg/ml ) and ANP levels ( above 50 pg/ml ) suggested the left ventricular dysfunction ( LVD ) . The patients ( n = 12 ) whose BNP levels reached to the LVD-positive levels showed the basal BNP levels above the normal upper limit ( 18 pg/ml ) , while the rest of subjects ( n = 18 ) whose basal BNP levels within normal limits did not showed the LVD-positive levels in the Pio-treatment . On the other h and basal ANP levels did not predict the development to LVD . In conclusion , BNP levels are suggested to be a good marker of Pio-induced LVD , and the Pio treatment of DM2 patients with BNP levels above the normal limit should be carefully carried out by monitoring BNP levels",
"BACKGROUND No pharmacologic therapy has conclusively proved to be effective for the treatment of nonalcoholic steatohepatitis , which is characterized by insulin resistance , steatosis , and necroinflammation with or without centrilobular fibrosis . Pioglitazone is a thiazolidinedione that ameliorates insulin resistance and improves glucose and lipid metabolism in type 2 diabetes mellitus . METHODS We r and omly assigned 55 patients with impaired glucose tolerance or type 2 diabetes and liver biopsy-confirmed nonalcoholic steatohepatitis to 6 months of treatment with a hypocaloric diet ( a reduction of 500 kcal per day in relation to the calculated daily intake required to maintain body weight ) plus pioglitazone ( 45 mg daily ) or a hypocaloric diet plus placebo . Before and after treatment , we assessed hepatic histologic features , hepatic fat content by means of magnetic resonance spectroscopy , and glucose turnover during an oral glucose tolerance test ( [14C]glucose given with the oral glucose load and [3H]glucose given by intravenous infusion ) . RESULTS Diet plus pioglitazone , as compared with diet plus placebo , improved glycemic control and glucose tolerance ( P normalized liver aminotransferase levels as it decreased plasma aspartate aminotransferase levels ( by 40 % vs. 21 % , P=0.04 ) , decreased alanine aminotransferase levels ( by 58 % vs. 34 % , P hepatic fat content ( by 54 % vs. 0 % , P hepatic insulin sensitivity ( by 48 % vs. 14 % , P=0.008 ) . Administration of pioglitazone , as compared with placebo , was associated with improvement in histologic findings with regard to steatosis ( P=0.003 ) , ballooning necrosis ( P=0.02 ) , and inflammation ( P=0.008 ) . Subjects in the pioglitazone group had a greater reduction in necroinflammation ( 85 % vs. 38 % , P=0.001 ) , but the reduction in fibrosis did not differ significantly from that in the placebo group ( P=0.08 ) . Fatigue and mild lower-extremity edema developed in one subject who received pioglitazone ; no other adverse events were observed . CONCLUSIONS In this proof-of-concept study , the administration of pioglitazone led to metabolic and histologic improvement in subjects with nonalcoholic steatohepatitis . Larger controlled trials of longer duration are warranted to assess the long-term clinical benefit of pioglitazone . ( Clinical Trials.gov number , NCT00227110 [ Clinical Trials.gov ] . )",
"OBJECTIVE Published reports suggest that pioglitazone and rosiglitazone have different effects on lipids in patients with type 2 diabetes . However , these previous studies were either retrospective chart review s or clinical trials not rigorously controlled for concomitant glucose- and lipid-lowering therapies . This study examines the lipid and glycemic effects of pioglitazone and rosiglitazone . RESEARCH DESIGN AND METHODS We enrolled subjects with a diagnosis of type 2 diabetes ( treated with diet alone or oral monotherapy ) and dyslipidemia ( not treated with any lipid-lowering agents ) . After a 4-week placebo washout period , subjects r and omly assigned to the pioglitazone arm ( n = 400 ) were treated with 30 mg once daily for 12 weeks followed by 45 mg once daily for an additional 12 weeks , whereas subjects r and omly assigned to rosiglitazone ( n = 402 ) were treated with 4 mg once daily followed by 4 mg twice daily for the same intervals . RESULTS Triglyceride levels were reduced by 51.9 + /- 7.8 mg/dl with pioglitazone , but were increased by 13.1 + /- 7.8 mg/dl with rosiglitazone ( P HDL cholesterol was greater ( 5.2 + /- 0.5 vs. 2.4 + /- 0.5 mg/dl ; P LDL cholesterol was less ( 12.3 + /- 1.6 vs. 21.3 + /- 1.6 mg/dl ; P pioglitazone compared with rosiglitazone , respectively . LDL particle concentration was reduced with pioglitazone and increased with rosiglitazone ( P LDL particle size increased more with pioglitazone ( P = 0.005 ) . CONCLUSIONS Pioglitazone and rosiglitazone have significantly different effects on plasma lipids independent of glycemic control or concomitant lipid-lowering or other antihyperglycemic therapy . Pioglitazone compared with rosiglitazone is associated with significant improvements in triglycerides , HDL cholesterol , LDL particle concentration , and LDL particle size",
"It is well known that pioglitazone , a potent thiazolidinedione , improves metabolic control . However , weight gain or peripheral edema may be of major clinical concern when using this agent . The purpose of our study was to prospect ively evaluate the effects of low-dose pioglitazone ( 7.5 mg/day ) on metabolic control , weight gain and the incidence of edema compared with a st and ard dose of pioglitazone ( 15.0 mg/day ) in patients with type 2 diabetes mellitus ( T2DM ) . Ninety-five Japanese female patients ( mean age 58.4 + /- 10.4 years ) with newly diagnosed T2DM were selected for this study . They were r and omly divided into the following 2 groups according to therapy regimens , and examined every month for 6 months after diagnosis . Group A consisted of 54 patients treated with low-dose pioglitazone orally ; Group B , the control-group , consisted of 41 patients treated with st and ard-dose pioglitazone orally . The incidence of peripheral edema was significantly much lower in group A ( 2/54 ) than in group B ( 11/41 ) ( p = 0.0014 ) . In addition , % change of body weight during the 6-month treatment in group A was significantly less than that in group B ( p % change of biochemical parameters including HbA1c did not differ significantly between group A and group B , although glucose and lipid control significantly improved from baseline in both groups . Our results demonstrate the safety and efficacy of low-dose pioglitazone , suggesting that it could be another good choice of treatment for Japanese women with T2DM",
"AIMS This study compared the effects of pioglitazone and gliclazide on metabolic control in drug-naive patients with Type 2 diabetes mellitus . METHODS A total of 1270 patients with Type 2 diabetes were r and omized in a parallel-group , double-dummy , double-blind study . Patients with poorly controlled Type 2 diabetes ( HbA1c 7.5 - 11 % ) , despite dietary advice , received either pioglitazone up to 45 mg once daily or gliclazide up to 160 mg two times daily . Primary efficacy endpoint was change in HbA1c from baseline to the end of the study . Secondary efficacy endpoints included change in fasting plasma glucose , fasting plasma insulin and plasma lipids . At selected centres , oral glucose tolerance tests were performed and C-peptide and pro-insulin levels were measured . RESULTS Mean HbA1c values decreased by the same amount in the two treatment groups from baseline to week 52 [ pioglitazone : -1.4 % ; gliclazide : -1.4 % ; ( 90 % CI : -0.18 to 0.02 ) ] . A significantly greater mean reduction in fasting plasma glucose was observed in the pioglitazone group ( 2.4 mmol/l ) than in the gliclazide group [ 2.0 mmol/l ; treatment difference -0.4 mmol/l in favour of pioglitazone ; P = 0.002 ; ( 95 % CI : -0.7 to -0.1 ) ] . Improvements in high-density lipoprotein cholesterol ( HDL-C ) and total cholesterol/HDL-C were greater with pioglitazone than with gliclazide ( P frequencies of adverse events were comparable between the two treatment groups , but more hypoglycaemic events were reported for gliclazide , whereas twice as many patients reported oedema with pioglitazone than with gliclazide . CONCLUSIONS Pioglitazone monotherapy was equivalent to gliclazide in reducing HbA1c , with specific differences between treatments in terms of mechanism of action , plasma lipids and adverse events"
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4117f528-06ff-11f0-808a-c43d1ab1c353
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This systematic review examined the characteristics of published cost-effectiveness analyses of inpatient smoking cessation programs and assessed the method ological quality of the selected studies , to provide policymakers with economic evidence for this type of program . A literature search was undertaken using a relevant data base by three investigators . Only full economic evaluations with results in the form of the incremental cost-effectiveness ratio ( ICER ) were included . Costs were adjusted to 2016 US dollars using the Gross Domestic Product deflator and purchasing power parities . The British Medical Journal checklist was utilized to appraise the method ological quality of the included studies . Nine articles were ultimately selected . The inpatient smoking cessation programs appeared to be a highly cost-effective intervention according to the recommended cost-effectiveness thresholds by the World Health Organization or individual studies . The highest ICERs among the selected studies were $ 5593 per additional quit , $ 10,550 per life year gained , and $ 5680 per quality -adjusted life year gained . This study provides robust evidence supporting the cost-effectiveness of smoking cessation programs for hospitalized patients . In addition , the results indicated that the degree of cost-effectiveness of the inpatient smoking cessation program might not be related to either the components of the program or method ological variations in the cost-effectiveness analysis . Policymakers should provide hospitals with re sources and strong incentives to promote wider implementation of the smoking cessation program
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"Purpose .To provide a practical quantitative tool for appraising the quality of cost-effectiveness ( CE ) studies . Methods .A committee comprised of health economists selected a set of criteria for the instrument from an item pool . Data collected with a conjoint analysis survey on 120 international health economists were used to estimate weights for each criterion with a r and om effects regression model . To vali date the grading system , a survey was sent to 60 individuals with health economics expertise . Participants first rated the quality of three CE studies on a visual analogue scale , and then evaluated each study using the grading system . Spearman rho and Wilcoxon tests were used to detect convergent validity and analysis of covariance ( ANCOVA ) for discriminant validity . Agreement between the global rating by experts and the grading system was also examined . Results .Sixteen criteria were selected . Their coefficient estimates ranged from 1.2 to 8.9 , with a sum of 93.5 on a 100-point scale . The only insignificant criterion was “ use of subgroup analyses . ” Both convergent validity and discriminant validity of the grading system were shown by the results of the Spearman rho ( correlation coefficient = 0.78 , P grading system had good agreement with global rating by experts . Conclusions . The instrument appears to be simple , internally consistent , and valid for measuring the perceived quality of CE studies . Applicability for use in clinical and re source allocation decision-making deserves further study",
"Many patients attempt to stop smoking during hospitalization , but most relapse after discharge . This study developed and evaluated a brief smoking-cessation and relapse-prevention program for hospitalized smokers . All hospitalized smokers ( n=1,119 ) were identified by question naire at hospital admission and then received either usual care or usual care plus a hospital-based smoking- cessation intervention regardless of interest in stopping smoking . Intervention components included a 20-minute bedside counseling session , a 12-minute videotape , a variety of self-help material s , and a follow-up telephone call . Special attention was given to techniques for preventing relapse after hospital discharge . Defining ex-smokers as those who reported no tobacco use at both 3- and 12-month follow-up assessment s , and counting those lost to follow-up as smokers , the intervention increased the proportion of patients who quit smoking by one half ( 9.2%vs 13.5 % , P cessation during hospitalization into longterm abstinence",
"BACKGROUND As many as 70 % of smokers with acute myocardial infa rct ion ( AMI ) continue to smoke after hospital discharge despite high rates of inpatient smoking cessation counseling . Supportive contact after discharge improves quit rates but is rarely used . METHODS Using data from a meta- analysis of r and omized trials of smoking cessation interventions and other published sources , we developed a Monte Carlo model to project health and economic outcomes for a hypothetical US cohort of 327,600 smokers hospitalized with AMI . We compared routine care , consisting of advice to quit smoking , with counseling with supportive follow-up , consisting of routine care and follow-up telephone calls from a nurse after discharge . Primary outcomes were number of smokers , AMIs , and deaths averted ; health care and productivity costs ; cost per quitter ; and cost per quality -adjusted life-year . RESULTS Implementation of smoking cessation counseling with follow-up contact for the 2010 cohort of hospitalized smokers would create 50,230 new quitters , cost $ 27.3 million in nurse wages and material s , and prevent 1380 nonfatal AMIs and 7860 deaths . During a 10-year period , it would save $ 22.1 million in reduced hospitalizations but increase health care costs by $ 166.4 million , primarily through increased longevity . Productivity costs from premature death would fall by $ 1.99 billion and nonmedical expenditures would increase by $ 928 million , for a net positive value to society of $ 894 million . The program would cost $ 540 per quitter considering only intervention costs . Cost-effectiveness would be $ 5050 per quality -adjusted life-year . Results were sensitive to the utility and incidence of nonfatal AMI and the potential effect of pharmacotherapies . CONCLUSION Smoking cessation counseling with supportive contact after discharge is potentially cost-effective and may reduce the incidence of smoking and its associated adverse health events and social costs",
"Objective This study examined the cost-effectiveness and cost-utility of two smoking cessation counseling interventions differing in their modality for patients diagnosed with coronary heart disease from a societal perspective . Methods In a r and omized controlled trial conducted in Dutch hospital wards , cardiac patients who smoked prior to admission were allocated to usual care ( n = 245 ) , telephone counseling ( n = 223 ) or face-to-face counseling ( n = 157 ) . The counseling interventions lasted for 3 months and were complemented by nicotine patches . Baseline histories were obtained , and interviews took place 6 months after hospitalization to assess self-reported smoking status and quality adjusted life years ( QALYs ) . Incremental cost-effectiveness ratios per quitter and cost-utility ratios per QALY were calculated and presented in acceptability curves . Uncertainty was accounted for by sensitivity analysis . Results Using continued abstinence as the outcome measure showed that telephone counseling had the highest probability of being cost-effective . Face-to-to-face counseling was also more cost-effective than usual care . No significant improvements and differences in QALYs between the three conditions were found . Varying costs and effect estimations revealed that the results of the primary analyses were robust . Conclusions Assuming a willingness-to-pay of € 20,000 per abstinent patient , telephone counseling would be a highly cost-effective smoking cessation intervention assisting cardiac patients to quit . However , the lack of consensus concerning the willingness-to-pay per quitter impedes drawing firm conclusions . Moreover , studies with extended follow-up periods are needed to capture late relapses and possible differences in QALYs",
"OBJECTIVE We examined the cost-effectiveness of smoking cessation treatment for psychiatric in patients . METHOD Smokers , regardless of intention to quit , were recruited during psychiatric hospitalization and r and omized to receive stage-based smoking cessation services or usual aftercare . Smoking cessation services , quality of life , and biochemically verified abstinence from cigarettes were assessed during 18 months of follow-up . A Markov model of cost-effectiveness over a lifetime horizon was constructed using trial findings and parameters obtained in a review of the literature on quit and relapse rates and the effect of smoking on health care cost , quality of life , and mortality . RESULTS Among 223 smokers r and omized between 2006 and 2008 , the mean cost of smoking cessation services was $ 189 in the experimental treatment group and $ 37 in the usual care condition ( P abstinent from cigarettes , compared to 6.80 % abstinence in the usual care group ( P lifetime cost and generated 0.101 additional quality -adjusted life-years ( QALYs ) , an incremental cost-effectiveness ratio of $ 428 per QALY . Probabilistic sensitivity analysis found the experimental intervention was cost-effective against the acceptance criteria of $ 50,000/QALY in 99.0 % of the replicates . CONCLUSIONS A cessation intervention for smokers identified in psychiatric hospitalization did not result in higher mental health care costs in the short-run and was highly cost-effective over the long-term . The stage-based intervention was a feasible and cost-effective way of addressing the high smoking prevalence in persons with serious mental illness . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00136812",
"OBJECTIVES This study evaluated the cost-effectiveness of a smoking cessation and relapse-prevention program for hospitalized adult smokers from the perspective of an implementing hospital . It is an economic analysis of a two-group , controlled clinical trial in two acute care hospitals owned by a large group-model health maintenance organization . The intervention included a 20-minute bedside counseling session with an experienced health counselor , a 12-minute video , self-help material s , and one or two follow-up calls . METHODS Outcome measures were incremental cost ( above usual care ) per quit attributable to the intervention and incremental cost per discounted life-year saved attributable to the intervention . RESULTS Cost of the research intervention was $ 159 per smoker , and incremental cost per incremental quit was $ 3,697 . Incremental cost per incremental discounted life-year saved ranged between $ 1,691 and $ 7,444 , much less than most other routine medical procedures . Replication scenarios suggest that , with realistic implementation assumptions , total intervention costs would decline significantly and incremental cost per incremental discounted life-year saved would be reduced by more than 90 % , to approximately $ 380 . CONCLUSIONS Providing brief smoking cessation advice to hospitalized smokers is relatively inexpensive , cost-effective , and should become a part of the st and ard of inpatient care",
"OBJECTIVE To determine the efficacy of a 22-mg nicotine patch combined with the National Cancer Institute program for physician advice and nurse follow-up in providing withdrawal symptom relief , 1-year smoking cessation outcome , and percentage of nicotine replacement . DESIGN R and omized , double-blind , placebo-controlled trial . SUBJECTS Two-hundred forty healthy volunteers who were smoking at least 20 cigarettes per day . INTERVENTIONS Based on the National Cancer Institute program , subjects received smoking cessation advice from a physician . Follow-up and relapse prevention were provided by a study nurse during individual counseling sessions . Subjects were r and omly assigned to 8 weeks of a 22-mg nicotine or placebo patch . MAIN OUTCOME MEASURES Abstinence from smoking was verified by expired air carbon monoxide levels . Withdrawal symptoms were recorded during patch therapy , and the percentage of nicotine replacement was calculated by dividing serum nicotine and cotinine levels at week 8 of patch therapy by levels obtained while smoking . RESULTS Higher smoking cessation rates were observed in the active nicotine patch group at 8 weeks ( 46.7 % vs 20 % ) ( P smoking cessation rates were also observed in subjects assigned to the active patch who had lower serum levels of nicotine and cotinine at baseline , and withdrawal symptom relief was better in the active patch group compared with placebo . CONCLUSIONS Clinical ly significant smoking cessation can be achieved using nicotine patch therapy combined with physician intervention , nurse counseling , follow-up , and relapse prevention . Smokers with lower baseline nicotine and cotinine levels had better cessation rates , which provides indirect evidence that they had more adequate nicotine replacement with this fixed dose of transdermal nicotine than those smokers with higher baseline levels",
"The effects of various smoking cessation strategies were studied in two multicentre trials with new patients attending hospital or a chest clinic because of a smoking related disease . In the first trial ( study A , 1462 patients ) the effect of the physician 's usual advice to stop smoking was compared with the effect of the same advice reinforced by a signed agreement to stop smoking by a target date within the next week , two visits by a health visitor in the first six weeks , and a series of letters of encouragement from the physician . The second trial ( study B , 1392 patients ) compared ( 1 ) advice only , ( 2 ) advice supplemented by a signed agreement , ( 3 ) advice supplemented by a series of letters of encouragement , and ( 4 ) advice supplemented by a signed agreement and a series of letters of encouragement . Patients were review ed at six months and those cl aim ing to have stopped smoking were seen again at 12 months . Cl aims of abstinence were checked by carboxyhaemoglobin measurement . In study A 9 % of the intervention group had succeeded in stopping smoking at six months compared with 7 % of the \" advice only \" patients ( p = 0.17 ) . In study B success rates were 5.2 % , 4.9 % , 8.5 % , and 8.8 % respectively . The signed agreement did not influence outcome , whereas postal encouragement increased the effect of the physician 's advice . In both studies patients review ed clinical ly between the initial and the six month visit were more likely to stop smoking than those not review ed . Success rates increased with age and men tended to do better than women . The studies suggest that physician 's advice alone will persuade 5 % of out patients with a smoking related disease to stop smoking . Subsequent postal encouragement will increase the cessation rate by more than half as much again . Such small improvements in success rates are worth while , especially if they can be achieved cheaply and on a wide scale",
"Background Smoking cessation is probably the most important action to reduce mortality after a coronary event . Smoking cessation programs are not widely implemented in patients with coronary heart disease , however , possibly because they are thought not to be worth their costs . Our objectives were to estimate the cost effectiveness of a smoking cessation program , and to compare it with other treatment modalities in cardiovascular medicine . Methods A cost-effectiveness analysis was performed on the basis of a recently conducted r and omized smoking cessation intervention trial in patients admitted for coronary heart disease . The cost per life year gained by the smoking cessation program was derived from the re sources necessary to implement the program , the number needed to treat to get one additional quitter from the program , and the years of life gained if quitting smoking . The cost effectiveness was estimated in a low-risk group ( i.e. patients with stable coronary heart disease ) and a high-risk group ( i.e. patients after myocardial infa rct ion or unstable angina ) , using survival data from previously published investigations , and with life-time extrapolation of the survival curves by survival function modeling . Results In a lifetime perspective , the incremental cost per year of life gained by the smoking cessation program was ∊280 and ∊110 in the low and high-risk group , respectively ( 2000 prices ) . These costs compare favorably to other treatment modalities in patients with coronary heart disease , being approximately 1/25 the cost of both statins in the low-risk group and angiotensin-converting enzyme inhibitors in the high-risk group . In a sensitivity analysis , the costs remained low in a wide range of assumptions . Conclusions A nurse-led smoking cessation program with several months of intervention is very cost-effective compared with other treatment modalities in patients with coronary heart disease",
"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",
"INTRODUCTION Interventions for hospitalized smokers can increase long-term smoking cessation rates . The Ottawa Model for Smoking Cessation ( the \" Ottawa Model \" ) is an application of the \" 5 A 's \" approach to cessation , customized to the hospital setting . This study evaluated the impact of implementing the Ottawa Model in 9 hospitals in eastern Ontario . METHODS The RE- AIM ( Reach , Efficacy , Adoption , Implementation , and Maintenance ) framework was used to evaluate the intervention . Trained outreach facilitators assisted 9 hospitals to implement the Ottawa Model ; program delivery was then monitored over a 1-year period using administrative data and data from a follow-up data base . A before- and -after study was conducted to gauge the effect of the Ottawa Model program on cessation rates 6 months after hospitalization . Self-reports of smoking cessation were biochemically confirmed in a r and om sample of patients , and all cessation rates were corrected for potential misreporting . RESULTS Sixty-nine percent of the expected number of smokers received the Ottawa Model intervention . Controlling for hospital , the confirmed 6-month continuous abstinence rate was higher after , than before , introduction of the Ottawa Model ( 29.4 % vs. 18.3 % ; odds ratio = 1.71 , 95 % CI = 1.11 - 2.64 ; Z = 2.43 ; I(2 ) = 0 % ; p = .02 ) . The intervention was more likely to accomplish counseling for smokers than delivery of medications or postdischarge follow-up . Attitudinal , managerial , and environmental challenges to program implementation were identified . DISCUSSION Trained outreach facilitators successfully implemented the Ottawa Model in 9 hospitals leading to significantly higher long-term cessation rates . The public health implication s of systematic cessation programs for hospitalized smokers are profound"
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CONTEXT The European Association of Urology Renal Cell Carcinoma Guideline Panel recently conducted a systematic review of treatment options for patients with advanced non-clear-cell renal cell carcinomas ( RCCs ) , which showed a substantial lack of evidence for management recommendations . OBJECTIVE To improve the outcomes of patients with rare kidney cancers ( RKCs ) , we performed a subsequent unstructured review to determine current treatment strategies and druggable pathways , involving key stakeholders with a global perspective to generate recommendations . EVIDENCE ACQUISITION Based on the systematic review , literature was queried in Pubmed , Medline , and abstract s from proceedings of European Society for Medical Oncology and American Society of Clinical Oncology , in addition to consulting key opinion leaders and stakeholders . A conventional narrative review strategy was adopted to summarize the data . EVIDENCE SYNTHESIS The systematic review showed an absence of evidence for treating RKCs , with data only supporting sunitinib or MET inhibitors for some specific subtypes . However , a growing body of evidence implicates druggable pathways in specific RKC subtypes . To test hypotheses , the small patient numbers in each subtype require coordinated multicenter efforts . Many RKC patients are currently excluded from studies or are not analyzed using subtype-specific parameters , despite their unmet medical need . CONCLUSIONS We recognize the need for additional multicenter studies and subtype-specific analyses ; however , we present management recommendations based on the data available . Web-based tools facilitating subtype-specific global registries and shared translational research re sources will help generate sufficient data to formulate evidence -based recommendations for guidelines . PATIENT SUMMARY Patients confronted with rare kidney cancers are often treated the same way as clear-cell renal cell carcinoma patients , despite little evidence from r and omized trials . Molecular characterization of tumors to stratify patients may improve outcomes . Availability of potential agents and trials remain a problem . Collaboration among medical centers is important to pool scarce data
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"PURPOSE Foretinib is an oral multikinase inhibitor targeting MET , VEGF , RON , AXL , and TIE-2 receptors . Activating mutations or amplifications in MET have been described in patients with papillary renal cell carcinoma ( PRCC ) . We aim ed to evaluate the efficacy and safety of foretinib in patients with PRCC . PATIENTS AND METHODS Patients were enrolled onto the study in two cohorts with different dosing schedules of foretinib : cohort A , 240 mg once per day on days 1 through 5 every 14 days ( intermittent arm ) ; cohort B , 80 mg daily ( daily dosing arm ) . Patients were stratified on the basis of MET pathway activation ( germline or somatic MET mutation , MET [ 7q31 ] amplification , or gain of chromosome 7 ) . The primary end point was overall response rate ( ORR ) . RESULTS Overall , 74 patients were enrolled , with 37 in each dosing cohort . ORR by Response Evaluation Criteria in Solid Tumors ( RECIST ) 1.0 was 13.5 % , median progression-free survival was 9.3 months , and median overall survival was not reached . The presence of a germline MET mutation was highly predictive of a response ( five of 10 v five of 57 patients with and without germline MET mutations , respectively ) . The most frequent adverse events of any grade associated with foretinib were fatigue , hypertension , gastrointestinal toxicities , and nonfatal pulmonary emboli . CONCLUSION Foretinib demonstrated activity in patients with advanced PRCC with a manageable toxicity profile and a high response rate in patients with germline MET mutations",
"Purpose The decreased effectiveness of single-agent targeted therapies in advanced non-clear cell renal cell carcinoma ( ncRCC ) compared with clear cell renal cell carcinoma ( RCC ) supports the study of combination regimens . We evaluated the efficacy of everolimus plus bevacizumab in patients with metastatic ncRCC . Patients and Methods In this single-center phase II trial , treatment-naive patients received everolimus 10 mg oral once per day plus bevacizumab 10 mg/kg intravenously every 2 weeks . The primary end point was progression-free survival ( PFS ) at 6 months . Correlative analyses explored c and i date tissue biomarkers through next-generation sequencing . Results Thirty-five patients were enrolled with the following histologic subtypes : chromophobe ( n = 5 ) , papillary ( n = 5 ) , and medullary ( n = 2 ) RCC and unclassified RCC ( uRCC , n = 23 ) . The majority of patients had papillary growth as a major component ( n = 14 ) . For 34 evaluable patients , median PFS , overall survival , and objective response rate ( ORR ) were 11.0 months , 18.5 months , and 29 % , respectively . PFS varied by histology ( P ORR was higher in patients with significant papillary ( seven of 18 ) or chromophobe ( two of five ) elements than for others ( one of 11 ) . Presence of papillary features were associated with benefit , including uRCC , where it correlated with ORR ( 43 % v 11 % ) , median PFS ( 12.9 v 1.9 months ) , and overall survival ( 28.2 v 9.3 months ; P somatic mutations in ARID1A were seen in five of 14 patients with papillary features but not in other RCC variants . All five patients achieved treatment benefit . Conclusion The study suggests efficacy for this combination in patients with ncRCC characterized by papillary features . Distinct mutational profiles among ncRCCs vary according to specific histology",
"Treatment options for metastatic clear cell renal cell carcinoma ( ccRCC ) have evolved markedly over the past decade , with multiple targeted therapies approved for the disease . In contrast , little improvement has been made in the management of metastatic non-clear cell RCC ( nccRCC ) . Non-clear cell disease is an umbrella term that encompasses multiple biologically distinct entities , including but not limited to papillary , chromophobe , and sarcomatoid RCC . To date , prospect i ve studies have largely explored treatments for ccRCC ( e.g. , VEGF- and mTOR-directed therapies ) in trials that aggregate non-clear cell histologies . However , the studies do not acknowledge the varying biology of each non-clear cell subtype . Emerging studies in nccRCC should examine individual histologies and apply biologically relevant therapies . An example of this is SWOG 1500 , a r and omized phase II study that will compare a VEGF-inhibitor to one of three MET-directed therapies in patients with metastatic papillary RCC . Until the biologic diversity of nccRCC is appreciated , outcomes are likely to remain dismal",
"Lessons Learned Our results highlight additional toxicities of dual PI3K/mTOR inhibition in the clinical setting that were unforeseen from pre clinical models . Because of toxicity and lack of efficacy , BEZ235 should not be further developed in the current formulation for patients with renal cell carcinoma . Background . Allosteric inhibitors of the mammalian target of rapamycin complex 1 ( mTORC1 ) are approved for advanced renal cell carcinoma ( RCC ) . Pre clinical models have suggested that dual inhibition of phosphatidylinositol 3-kinase ( PI3 K ) and mTOR kinase may establish superior anticancer effect . We aim ed to establish safety for BEZ235 , a potent inhibitor of both PI3 K and mTOR , in advanced RCC . Methods . Patients with advanced RCC who had previously failed st and ard therapy received escalating doses of BEZ235 in sachet formulation twice daily until progression or unacceptable toxicity . Primary endpoints were to identify the maximally tolerated dose ( MTD ) and to determine the recommended dose for the phase II study . Results . The study was terminated early because of high incidence of dose-limiting toxicities ( DLTs ) across all dose levels tested . Ten patients were treated with BEZ235—six with clear cell and four with non-clear cell subtypes . Five of these patients suffered DLTs : 2 of 2 patients in the original 400 mg b.i.d . cohort , 1 of 6 in the 200 mg b.i.d . cohort , and 2 of 2 in the 300 mg b.i.d . cohort . DLTs included fatigue , rash , nausea and vomiting , diarrhea , mucositis , anorexia , and dysgeusia . Five patients were evaluable for response : Two had stable disease as best response , and three had progressive disease . Conclusion . BEZ235 twice daily result ed in significant toxicity without objective responses ; further development of this compound will not be pursued in this disease"
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In the report Crossing the Quality Chasm ( 1 ) , the Institute of Medicine called attention to the poor quality of health care in the United States . The Institute identified numerous factors contributing to poor quality , including the structure of the present health care payment system . The Institute found that , for certain clinical situations , health care payment arrangements may actually produce disincentives for quality . The largely untapped potential of the health care payment system to change physician and health care system behavior has stimulated interest in both the scientific literature ( 2 , 3 ) and the popular press ( 4 - 6 ) for linking payments to performance on quality measures . Several health plans ( 3 , 7 ) and the Centers for Medicare & Medicaid Services are using explicit financial incentives for quality ( 8 , 9 ) . The effectiveness of these programs has not been systematic ally evaluated , and despite enthusiasm about the potential for aligning financial incentives with high- quality health care , many fundamental questions about their optimal design , effectiveness , and implementation remain unanswered . For example , what types of clinical conditions or health care services should be the target of financial incentives to improve quality : chronic diseases , acute care , or preventive care services ? How effective ( and cost-effective ) are financial incentives for quality ? What are the optimum magnitude , frequency , and duration of financial incentives for quality ? Should we reward achievement of an absolute threshold of performance , improvement over baseline performance , payment for each instance of a service regardless of the overall performance , or some combination of these ? To whom should such incentives be directed : the patient ( 10 ) , the health care provider , the provider group or hospital , or all of these parties ? What types of quality measures should be rewarded : processes of care , outcomes , or both ( 11 ) ? Are financial incentives for not providing inappropriate care ( such as antibiotics for uncomplicated acute upper respiratory illnesses ) effective ? What is the optimum package of nonfinancial interventions ( if any ) to include with financial incentives for quality , for example , audit and feedback , recognition , clinical reminders , academic detailing , or information technology support ( 12 , 13 ) ? Can we expect the effect of financial incentives to persist after they are stopped ? Because any effective intervention will have some unanticipated effects , will important patient care activities that are not rewarded financially be neglected ? The purpose of this paper is to assess the relationship between explicit financial incentives and the provision of high- quality health care by systematic ally review ing empirical studies . Because the evidence regarding the relationship between the financial incentives embedded in fee-for-service and capitation arrangements and the quality of health care has been thoroughly review ed in previous work ( 14 ) , we focused our review on literature that addresses explicit financial rewards for improving health care quality . Methods Study Identification and Selection We conducted a systematic search of the English- language literature in PubMed to find articles published between 1 January 1980 and 14 November 2005 whose main objective was to assess the use of explicit financial incentives to improve health care quality . Our search algorithms combined Medical Subject Heading ( MeSH ) terms and text words . We used the following MeSH terms : quality of health care ; insurance , health , reimbursement ; physician incentive plans ; and reimbursement , incentive . We design ated words and word phrases as text word terms in our search algorithms to ensure that all words in the title , abstract , MeSH terms , and MeSH subheadings that matched our words were extracted from the electronic data base ( 15 ) . We indicated the following words and phrases as text word terms in our search : quality , quality of care , payment , payment system , reimbursement , risk adjustment , physicians , financial incentives , financing , incentive , health care , bonus , insurance , performance-based , and fees . We review ed additional publications found in bibliographies of retrieved articles , and we contacted experts about missing or unpublished studies . We included only English- language studies that reported original data . We were interested in identifying studies of explicit financial incentives directed at individual physicians and provider groups , as well as incentives at the level of the payment system , such as performance-based contracting . Eligible studies assessed the use of financial incentives as the independent variable and a measure of quality ( such as immunization or cancer screening ) as the dependent variable . Quality of care was defined as the degree to which health care services for individuals and population s increase the likelihood of desired health outcomes and are consistent with current professional knowledge ( 16 ) . The domains of quality were defined as access to care , structure of care , process of care , outcomes of care , and patient experience of care . Access to care is the patient 's attainment of timely and appropriate health care . Structure of care is a feature of a health care organization or clinician relevant to the provision of health care . Process of care is a health care service provided to or on behalf of a patient . Outcome of care is a health state of a patient result ing from health care . Experience of care is the individual 's or population 's report concerning health care ( 17 ) . Study Inclusion Criteria Studies were eligible for review if they were original reports providing empirical results and assessed the relationship between the explicit financial incentive and a quantitative measure of health care quality ( 17 ) . Review ers assessed articles in an unblinded , st and ardized manner ( 18 , 19 ) . At least 2 authors review ed the title and keywords of articles ' PubMed citations to identify empirical studies . At least 2 authors then review ed the abstract s of those studies to determine eligibility . All authors then abstract ed and review ed the full articles that addressed the objective of the review . When there were discrepancies , all authors met to discuss and reach consensus about article inclusion . There were no instances of disagreement in which consensus could not be reached . We excluded eligible studies if there was no concurrent comparison group or if there was no baseline , preintervention analysis of the groups on the quality measure . Concurrent comparison groups are important because some studies of quality may show dramatic improvement over time but no statistically significant differences between intervention and comparison groups . We included r and omized , controlled trials and controlled before- and -after studies . Because of the paucity of literature on this topic , we also included observational studies that , although not study ing a specific intervention , nevertheless examined the relationship between financial incentives and quality in a cross-sectional analysis . We categorized the results of each study according to the effect of the financial incentive on the measure or measures of quality . Positive studies were those for which all measures of quality demonstrated a statistically significant improvement with the financial incentive . Studies with partial effects showed improved performance on some measures of quality but not others . Negative studies were those for which all measures of quality demonstrated a statistically significant decrease in quality with the financial incentive . The final category was for studies demonstrating no effect . We used a checklist for method ologic quality published by Downs and Black ( 20 ) . After we assessed the checklist for each article , a grade of 1 ( poor ) to 4 ( excellent ) was assigned to each included article . We did not use formal meta-analytic techniques because the included studies used many different measures of effect . Role of the Funding Sources The Veterans Health Administration , the Robert Wood Johnson Foundation , the American Heart Association , and the National Institutes of Health supported this study but had no role in design , conduct , or reporting or in the decision to su bmi t the paper for publication . Results Search Results Our search for eligible studies is summarized in the Figure . Most of the articles were descriptions and not evaluations . Sixteen articles ( 21 - 36 ) that met the eligibility criteria were subsequently excluded because a concurrent comparison group was not analyzed or groups were not compared at baseline on the quality indicator ( Table 1 ) . The Appendix Table summarizes the 17 included studies . Two studies reported the effect of payment-system level financial incentives ( 37 , 38 ) . The remaining 15 studies evaluated financial incentives directed to the provider group ( 39 - 47 ) or individual physician ( 48 - 53 ) . Appendix Table . Articles Identified as Assessing Explicit Financial Incentives and Health Care Quality from a Systematic Review of the Literature after Applying Study Inclusion and Exclusion Criteria Figure . Studies published between 1 January 1980 and 14 November 2005 and evaluated for inclusion in the systematic review of explicit financial incentives for health care quality . Table 1 . Excluded Articles and Reason for Exclusion Financial Incentives at the Payment System Level We found 2 studies of financial incentives provided at the payment system level ( 37 , 38 ) . For example , Norton ( 37 ) studied the effectiveness of an incentive to improve access to health care for nursing home patients with debilitating acute and chronic conditions . The program included incentives to admit severely dependent patients , incentives for attainment of health status goals , and an incentive to discharge clinical ly appropriate patients . The intervention sites admitted statistically significantly more severely ill patients than nursing homes in the control group . Despite the
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"Objective . Immunizations and other cost-effective preventive services remain underused by many children , especially those living in poverty . Given the effectiveness of provider-based tracking systems and the widespread use by managed care organizations of financial incentives to influence physician practice patterns , we design ed and tested an intervention combining these strategies . We studied whether a system of semiannual assessment and feedback , coupled with financial incentives , could improve pediatric preventive care in a Medicaid health maintenance organization ( HMO ) . Methodology . We r and omly assigned primary care sites serving children in a Medicaid HMO to one of three groups : a feedback group ( where physicians received written feedback about compliance scores ) , a feedback and incentive group ( where physicians received feedback and a financial bonus when compliance criteria were met ) , and a control group . We evaluated compliance with pediatric preventive care guidelines through semiannual chart audits during the years 1993 to 1995 . Results . Compliance with pediatric preventive care improved dramatically in the study period . Repeated measures ANOVA demonstrated a significant increase in all three study groups throughout the time in total compliance scores ( from 56%–73 % ) , as well as scores for immunizations ( from 62%–79 % ) and other preventive care ( from 54%–71 % ) . However , no significant differences were observed between either intervention group and the control group , nor were there any interaction ( group-by-time ) effects . Conclusions . Feedback to physicians , with or without financial incentives , did not improve pediatric preventive care in this Medicaid HMO during a time of rapid , secular improvements in care . Possible explanations include the context and timing of the intervention , the magnitude of the financial incentives , and lack of physician awareness of the intervention",
"OBJECTIVE To determine the effects of a financial incentive on the number and types of cognitive services ( CS ) provided by community pharmacies to Medicaid recipients in the State of Washington . DESIGN Prospect i ve r and omized trial . CS were reported using a problem-intervention- result coding system over a 20-month period . SETTING AND SUBJECTS Pharmacists practicing in 110 study ( financial incentive ) and 90 control community pharmacies . RESULTS Study pharmacists documented an average of 1.59 CS interventions per 100 prescriptions over a 20-month period , significantly more than controls , who documented an average of 0.67 interventions ( P change in drug therapy occurred as a result of 28 % of all CS documented in this demonstration . Changes were rarely ( 2.4 % ) due to generic or therapeutic substitution and almost always ( 90 % ) followed communication with the prescriber . The average self-reported time to perform CS was 7.5 minutes ; 75 % of interventions were types of problems identified , intervention activities performed , and results of interventions . CONCLUSION A financial incentive was associated with significantly more , and different types of , CS performed by pharmacists",
"OBJECTIVE This study determined the effect of 2 financial incentives --- bonus and enhanced fee-for-service --- on documented immunization rates during a second period of observation . METHODS Incentives were given to 57 r and omly selected inner-city physicians 4 times at 4-month intervals based on the performance of 50 r and omly selected children . Coverage from linked records from all sources was determined for a sub sample of children within physician offices . RESULTS Up-to- date coverage rates documented in the charts increased significantly for children in the bonus group ( 49.7 % to 55.6 % ; P enhanced fee-for-service group ( 50.8 % to 58.2 % ; P control group . The number of immunizations given by these physicians did not change significantly , although the number of immunizations given by others and documented by physicians in the bonus group did increase ( P Up-to- date coverage for all groups increased from 20 to 40 percentage points when immunizations from physician charts were combined with other sources . CONCLUSIONS Both financial incentives produced a significant increase in coverage levels . Increases were primarily due to better documentation not to better immunizing practice s. The financial incentives appeared to provide motivation to physicians but were not sufficient to overcome entrenched behavior patterns . However , true immunization coverage was substantially higher than that documented in the charts",
"OBJECTIVE To determine the probable effect of the Vaccines for Children ( VFC ) program on immunization coverage . DESIGN Preintervention and postintervention study design , with data collected before and after enrollment in the VFC program . SETTING Twenty-three inner-city neighborhood physicians ' offices in New York City . PARTICIPANTS In 1993 , 30 physicians were r and omly selected from 8 neighborhoods with the highest proportions of Medicaid-eligible individuals in New York City . In 1995 - 1996 , the 30 physicians were contacted again . Twenty-three agreed to an interview and medical record review . Within each office , the medical records of children aged 3 to 35 months , with at least 3 visits in a 3-month or longer period , were r and omly selected . Medical record review s were conducted for 173 eligible children in 1993 and 528 in 1995 - 1996 . INTERVENTIONS The VFC program was implemented in October 1994 . The administration fee increased from $ 2 to $ 17.85 ; physicians received vaccines free . MAIN OUTCOME MEASURES Up-to- date status for immunizations and lead and tuberculosis screening ; percentage of visits that are missed opportunities to immunize ; and percentage of visits that were well-child visits . Up-to- date status , missed opportunities to immunize , and well-child visits were compared across time using chi 2 analysis , corrected for the use of cluster sampling . RESULTS Up-to- date status changed significantly before and alter enrollment in the VFC program ( P diphtheria toxoid , tetanus toxoid , and pertussis vaccine , oral poliovirus vaccine , and measles , mumps , and rubella vaccine combined , coverage increased from 17.9 % to 42.2 % , up by 24.3 percentage points ( P Missed opportunities to immunize did not change , but well-child visits increased from 15.0 % to 21.6 % ( P performance improvements to the VFC program and not to other competing hypotheses . CONCLUSIONS The VFC program seems to be responsible for an increase in immunization rates among these physicians",
"BACKGROUND This study tested the effects of two organizational support processes , the provision of financial incentives for superior clinical performance and the availability of a patient ( smoker ) registry and proactive telephone support system for smoking cessation , on provider adherence to accepted practice guidelines and associated patient outcomes . METHODS Forty clinics of a large multispecialty medical group practice providing primary care services were r and omly allocated to study conditions . Fifteen clinics each were assigned to the experimental conditions \" control \" ( distribution of printed versions of smoking cessation guidelines ) and \" incentive \" ( financial incentive pay-out for reaching preset clinical performance targets ) . Ten clinics were r and omized to receive financial incentives combined with access to a central ized patient registry and intervention system ( \" registry \" ) . Main outcome measures were adherence to smoking cessation clinical practice guidelines and patients ' smoking cessation behaviors . RESULTS Patients ' tobacco use status was statistically significant ( P accessed counseling programs statistically significantly more often ( P financial incentives and a patient registry/intervention system in improving smoking cessation clinical practice s and patient behaviors was mixed . Additional research is needed to identify conditions under which such organizational support processes result in significant health care quality improvement and warrant the investment",
"OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity",
"OBJECTIVES A r and omized controlled trial evaluated the impact of feedback and financial incentives on physician compliance with cancer screening guidelines for women 50 years of age and older in a Medicaid health maintenance organization ( HMO ) . METHODS Half of 52 primary care sites received the intervention , which included written feedback and a financial bonus . Mammography , breast exam , colorectal screening , and Pap testing compliance rates were evaluated . RESULTS From 1993 to 1995 , screening rates doubled overall ( from 24 % to 50 % ) , with no significant differences between intervention and control group sites . CONCLUSIONS Financial incentives and feedback did not improve physician compliance with cancer screening guidelines in a Medicaid HMO",
"Serving people with mental and other chronic illnesses in community setting s may improve compliance and satisfaction with treatment , but existing payment mechanisms often favor office-based treatment . This study examines the effect of a change in Medicaid payment on the location and amount of service provided by case managers . Amounts of service given by treatment providers to 185 of their clients in community setting s and in mental health centers were compared before and after reimbursement changed from an all-inclusive prospect i ve rate to a mixed prospect ive/retrospective payment . Clients were enrolled in two different treatment programs : continuous treatment teams with extensive training in in vivo treatment , and a case management program that emphasized office-based treatment . In-community service increased , and the amount of office-based treatment decreased . Continuous treatment teams increased in-community services more than case managers did ; case managers decreased office-based treatment more . There was no change in total amount of services provided . It was concluded that mixed prospect i ve and retrospective reimbursement can remove financial barriers to in-community treatment , but it works best in combination with a training program . Additional research is needed to determine the precise financial impact of such changes",
"BACKGROUND This 1-year r and omized trial tested the efficacy of behavioral techniques for increasing mammography referrals by primary care physicians in small , community practice s. METHODS Sixty-one practice s were r and omly assigned to one of three conditions : ( 1 ) education-only control , ( 2 ) education plus cue enhancement using mammography chart stickers , and ( 3 ) education plus cue enhancement plus feedback and token rewards . Quarterly chart audits of a defined sample ( N = 11,716 ) of women patients 50 years of age or older were conducted to document mammography referrals , completions , and compliance . RESULTS Referral and completion rates increased from baseline to first quarter and gradually declined thereafter . Overall , these rates were higher in the cuing conditions than in the control condition . In contrast , compliance rates in both experimental conditions increased over the year while remaining static in the control condition , demonstrating a strong and continuing effect for cue enhancement . Compliance increases were greatest for physicians who were older , nonwhite , with a second speciality , in solo practice , not members of the AMA , not residency trained , and not board certified . CONCLUSIONS Chart stickers can significantly increase mammography utilization in small , community practice s. These practice s are an efficient route to reaching large numbers of older women in need of mammography screening",
"OBJECTIVES The purpose of this study was to examine the effects on immunization coverage of 3 incentives for physicians -- a cash bonus for practice --wide increases , enhanced fee for service , and feedback . METHODS Incentives were applied at 4-month intervals over 1 year among 60 inner-city office-based pediatricians . At each interval , charts of 50 r and omly selected children between 3 and 35 months of age were review ed per physician . RESULTS The percentage of children who were up to date for diphtheria , tetanus , and pertussis and Haemophilus influenzae type b ; polio ; and measles-mumps-rubella immunization in the study 's bonus group improved by 25.3 percentage points ( P percentage of immunizations received outside the participating practice also increased significantly in the bonus group ( P Levels of missed opportunities to immunize were high in all groups and did not change over time . Physicians ' knowledge of contraindications was low . CONCLUSIONS Bonuses sharply and rapidly increased immunization cover-age in medical records . However , much of the increase was the result of better documentation . A bonus is a powerful incentive , but more structure or education may be necessary to achieve the desired results",
"OBJECTIVE To determine the effectiveness of different types of interventions in improving health professional performance and health outcomes . DATA SOURCES MEDLINE , SCI SEARCH , CINAHL and the Research and Development Re source Base in CME were search ed for trials of educational interventions in the health care professions published between 1970 and 1993 inclusive . STUDY SELECTION Studies were selected if they provided objective measurements of health professional performance or health outcomes and employed r and om or quasi-r and om allocation methods in their study design s to assign individual subjects or groups . Interventions included such activities as conferences , outreach visits , the use of local opinion leaders , audit and feedback , and reminder systems . DATA EXTRACTION Details extracted from the studies included the study design ; the unit of allocation ( e.g. , patient , provider , practice , hospital ) ; the characteristics of the targeted health care professionals , educational interventions and patients ( when appropriate ) ; and the main outcome measure . DATA SYNTHESIS The inclusion criteria were met by 102 trials . Areas of behaviour change included general patient management , preventive services , prescribing practice s , treatment of specific conditions such as hypertension or diabetes , and diagnostic service or hospital utilization . Dissemination-only strategies , such as conferences or the mailing of unsolicited material s , demonstrated little or no changes in health professional behaviour or health outcome when used alone . More complex interventions , such as the use of outreach visits or local opinion leaders , ranged from ineffective to highly effective but were most often moderately effective ( result ing in reductions of 20 % to 50 % in the incidence of inappropriate performance ) . CONCLUSION There are no \" magic bullets \" for improving the quality of health care , but there are a wide range of interventions available that , if used appropriately , could lead to important improvements in professional practice and patient outcomes"
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4117f636-06ff-11f0-808a-c43d1ab1c353
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Background Fatigue is the most frequent symptom reported by patients with chronic illnesses . As a subjective experience , fatigue is commonly assessed with patient-reported outcome measures ( PROMs ) . Currently , there are more than 40 generic and disease-specific PROMs for assessing fatigue in use today . The interpretation of changes in PROM scores may be enhanced by estimates of the so-called minimal important difference ( MID ) . MIDs are not fixed attributes of PROMs but rather vary in relation to estimation method , clinical and demographic characteristics of the study group , etc . The purpose of this paper is to compile published MIDs for fatigue PROMs , spanning diagnostic/patient groups and estimation methods , and to provide information relevant for appraising their appropriateness for use in specific clinical trials and in monitoring fatigue in defined patient groups in routine clinical practice . Methods A systematic search of three data bases ( Scopus , CINAHL and Cochrane ) for studies published between January 2000 to April 2015 using fatigue and variations of the term MID , e.g. MCID , MIC , etc . Two authors screened search hits and extracted data independently . Data regarding MIDs , anchors used and study design s were compiled in tables . Results Included studies ( n = 41 ) reported 60 studies or sub studies estimating MID for 28 fatigue scales , subscales or single item measures in a variety of diagnostic groups and study design s. All studies used anchor-based methods , 21/60 measures also included distribution-based methods and 17/60 used triangulation of methods . Both similarities and dissimilarities were seen within the MIDs . Conclusions Magnitudes of published MIDs for fatigue PROMs vary considerably . Information about the derivation of fatigue MIDs is needed to evaluate their applicability and suitability for use in clinical practice and research
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"Abstract Objectives : Chronic insomnia and depression are often associated . Measuring the impact on quality of life associated with changes in sleep in co-treatment of insomnia and depression requires a valid and reliable patient reported outcome ( PRO ) instrument . This study aim ed to assess the validity of the Sleep Impact Scale ( SIS ) , a sleep-specific PRO instrument , in a population comorbid with Major Depressive Disorder ( MDD ) and insomnia to support its use in clinical or clinical trial applications . Research design and methods : Data from 379 subjects enrolled in a 27 week US , multi-center , phase IV , r and omized , double-blind , parallel group , placebo-controlled trial of zolpidem tartrate extended-release taken in combination with escitalopram vs. placebo combined with escitalopram were pooled across treatment groups . Results from multi-trait analyses , tests of internal consistency and test – retest reliability , concurrent validity , known-groups validity , responsiveness , and thresholds for minimal important difference ( MID ) were examined . Results : Mean baseline scores on the SIS ranged from 22.85 ( ±13.41 ) on Satisfaction with Sleep to 43.49 ( ±21.12 ) on Mental Fatigue , reflecting impairments due to sleep problems . The SIS was found to be internally consistent ( α ≥ 0.70 for all domains ) and have good construct validity . The item – domain correlations were ≥0.52 with no instance of an item correlating more highly with a domain other than its own . There were some floor and no ceiling effects . The test – retest reliability of the SIS domains ranged between 0.68 and 0.83 . Clinical validity assessed through known groups methods was supported . The SIS was responsive to changes on all domains . Preliminary estimates of minimum important difference ( MID ) were obtained to interpret changes in SIS domains . Limitations : Limitations include the need for further qualitative research on content validity and the lack of a patient global assessment of change . Conclusions : This study yielded adequate evidence of the validity of the SIS for use in clinical trials and research on MDD patients with comorbid insomnia",
"Health-related quality of life ( HrQOL ) assessment s are gaining importance as outcome measures in cancer clinical trials . A recently published clinical trial reported statistically significant ( P HrQOL scores following the administration of recombinant human erythropoietin ( r-HuEPO , epoetin alfa ) versus placebo to anaemic cancer patients who received non-platinum chemotherapy . This study employed five cancer-specific HrQOL instruments . Hb and HrQOL data from this trial were analysed to estimate the minimally important difference ( MID ) in HrQOL measures that could be interpreted as clinical ly meaningful , with Hb level selected as the best external st and ard . Patients were assigned to two groups : improved ( Hb increases of > /=1 g/dL ) or stable ( change in Hb of-1 g/dL to HrQOL in the improved group versus the stable group . By this analysis , the differences in HrQOL scores between the epoetin alfa group and the placebo group were clinical ly important for all Hb-sensitive , cancer-specific HrQOL evaluations . Linear regression analyses performed to provide estimates of the MID for specific values of Hb change confirmed that the differences in HrQOL scores between patient groups were clinical ly significant . These analyses were repeated using a data set from a separate clinical trial , which further supported the conclusion that observed HrQOL changes demonstrated in the multicentre , double-blind study were clinical ly important . These methods provide one means for interpreting the clinical relevance of changes in HrQOL evaluated in clinical trials",
"In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials",
"Modern clinical trials provide the evidence for most therapeutic advances , and that evidence , expressed in a statistical format , is used to draw inferences about a population from the study 's results . Clinician judgment translates these inferences for best individual patient care , but many clinicians struggle with the statistical interpretation of trial results . This review provides a clinical and non-Bayesian perspective on some key elements in the statistical design , analysis , and interpretation of r and omized , comparative , phase III clinical trials intended to demonstrate a better outcome ( superiority ) than with a control treatment",
"Purpose The Multidimensional Fatigue Inventory ( MFI ) is a commonly used cancer-related fatigue assessment tool . Unlike other fatigue assessment s , there are no published minimal clinical ly important difference ( MCID ) criteria for the MFI in cancer population s. MCID criteria determine the smallest change in scores that can be regarded as important , allowing clinicians and research ers to interpret the meaning of changes in patient ’s fatigue scores . This research aims to improve the clinical utility of the MFI by establishing MCID criteria for the MFI sub-scales in a radiotherapy population . Material s and methods Two hundred ten patients undergoing radiotherapy were recruited to a single-centre prospect i ve cohort study . Patients were assessed at three time points , at the start of radiotherapy , the end of radiotherapy and 6 weeks after radiotherapy completion . Assessment consisted of four clinical ly relevant constructs : ( 1 ) treatment impact on fatigue , ( 2 ) health-related quality of life , ( 3 ) performance status and ( 4 ) occupational productivity . These constructs were used as external or anchor-based measures to determine MCIDs for each sub-scale of the MFI . Results Multiple MCIDs were identified , each from a different perspective based on the constructs cited . Research ers seeking to use a generic MCID may wish to use a two-point reference for each MFI sub-scale as it was consistent across the pre- and post-radiotherapy comparison and occupational productivity anchors . Conclusions MCIDs vali date d in this study allow better interpretation of changes in MFI sub-scale scores and allow effect size calculations for determining sample size in future studies",
"OBJECTIVE This study vali date d a brief measure of fatigue in rheumatoid arthritis ( RA ) , the Functional Assessment of Chronic Illness Therapy ( FACIT ) Fatigue Scale . METHODS The FACIT Fatigue was tested along with measures previously vali date d in RA : the Multidimensional Assessment of Fatigue ( MAF ) and Medical Outcomes Study Short-Form 36 ( SF-36 ) Vitality . The sample included 636 patients with RA enrolled in a 24 week double blind , r and omized clinical trial ( RCT ) of adalimumab versus placebo . RESULTS The FACIT Fatigue showed good internal consistency ( alpha = 0.86 to 0.87 ) , strong association with SF-36 Vitality ( r = 0.73 to 0.84 ) and MAF ( r = -0.84 to -0.88 ) , and the ability to differentiate patients according to clinical change using the American College of Rheumatology ( ACR ) response criteria ( ACR 20/50/70 ) . Psychometric performance of the FACIT Fatigue scale was comparable to that of the other 2 fatigue measures . A minimally important difference in FACIT Fatigue change score of 3 - 4 points was confirmed in a separate sample of 271 patients with RA enrolled in a second double blind RCT of adalimumab versus placebo . CONCLUSION The FACIT Fatigue is a brief , valid measure for monitoring this important symptom and its effects on patients with RA",
"OBJECTIVE To define clinical ly meaningful changes in 2 widely used health-related quality of life ( HQL ) instruments in studies of patients with rheumatoid arthritis ( RA ) . METHODS Patients with RA ( n = 693 ) who were enrolled in 2 double-blind , placebo-controlled clinical trials completed the Short Form 36 ( SF-36 ) modified health survey and the Health Assessment Question naire ( HAQ ) disability index at baseline and 6-week followup assessment s. Data on 5 RA severity measures were also collected at baseline and at 6 weeks ( patient and physician global assessment s , joint swelling and tenderness counts , and global pain assessment ) . Comparison of changes in the SF-36 scales and HAQ scores was made between groups of patients known to differ in the level of change on each RA severity measure . RESULTS With few exceptions , changes in the SF-36 and HAQ scores were different between patients who differed in the level of change on each RA severity measure . Changes in the SF-36 and HAQ scores were more strongly related to changes in the patient and physician global assessment s and patient pain assessment than to changes in the joint swelling and tenderness counts . CONCLUSION Based on these results , minimally important changes in the SF-36 scales and HAQ disability scores were determined , which will be useful in interpreting HQL results in clinical trials",
"OBJECTIVES Estimates of minimal clinical ly important differences in health measures may be affected by the anchor used . We examined if domain-specific transition questions had higher construct validity than global health transition questions as anchors for measures in a given domain . STUDY DESIGN AND SETTING In a prospect i ve study of 249 patients with rheumatoid arthritis , we examined changes in pain , physical function , joint swelling , stiffness , fatigue , and depression with treatment . We related these changes to a domain-specific transition question , global arthritis transition question , and the Short Form-36 ( SF-36 ) health transition item . RESULTS Changes in all six clinical measures were more highly correlated with the domain-specific transition questions than with the global arthritis question and SF-36 transition question . Discrimination between patients who improved or not was also better using domain-specific questions . Estimates of minimal clinical ly important improvement ( MCII ) differed with the anchor when these were based on mean changes . MCII estimates from receiver operating characteristic curve analysis were not influenced by the choice of anchor when anchors had high agreement . CONCLUSION Domain-specific transition questions had higher construct validity as anchors for determining clinical ly important differences in health measures focused on a single domain than either global disease or general health transition questions",
"OBJECTIVE To determine the minimal clinical ly important differences ( MCID ) in the patient-reported outcomes of activity ( 0 - 30 , number of days of limitation ) , fatigue ( 0 = none , 100 = complete ) , and sleep quality ( 0 = no problems , 100 = worst case ) for patients with rheumatoid arthritis ( RA ) . METHODS Two r and omized controlled trials comparing abatacept to placebo in RA patients were considered : ATTAIN ( n = 391 ) and AIM ( n = 652 ) . An internal anchor-based approach was used to derive the MCID using the Health Assessment Question naire , patient global assessment , and pain as anchors . Minimal important change in activity , fatigue , and sleep were determined by estimating mean changes in these outcomes in patients showing change in a narrow range about the MCID of the internal anchor . Correlation analysis was used to determine the consistency of the changes in the outcomes and anchors , and a Delphi process was used to determine the final MCID values . RESULTS For the 2 trials , consistent patterns of change for activity , fatigue , and sleep and the internal anchors were found with correlations in the range of 0.5 , 0.7 , and 0.4 , respectively . The mean changes for activity , fatigue , and sleep in a narrow range about the MCID of the 3 internal anchors corresponding to the 2 trials were : 3.4 to 4.3 for activity ; 6.7 to 17.0 for fatigue ; and 4.1 to 7.3 for sleep . Following the Delphi process the MCID determined were 4 for activity , 10 for fatigue , and 6 for sleep . CONCLUSION These MCID for activity limitation , fatigue , and sleep problems can be used in design ing clinical trials and providing benchmarks in assessing patient improvement",
"OBJECTIVE The usefulness of any question naire in clinical management and research trials depends on its ability to indicate a likelihood of treatment success during follow-up . The Minimal Clinical ly Important Difference ( MCID ) reflects a clinical ly relevant change score . The aim of this study was to estimate the MCID for the Fatigue Assessment Scale ( FAS ) in patients with sarcoidosis . METHODS Out patients ( n = 321 ) of the ild care team of the Department of Respiratory Medicine of the Maastricht University Medical Centre , The Netherl and s , participated in this prospect i ve follow-up study . Anchor-based and distribution-based methods were used to estimate the MCID . Based on the anchor Physical Quality of Life , a Receiver Operating Characteristic ( ROC ) was obtained . The distribution-based methods consisted of the Effect Size and St and ard Error Measurement ( SEM ) . RESULTS The anchor-based MCID found with ROC was 3.5 . The distribution-based methods showed that the corresponding change scores in the FAS for a small effect was 4.2 . The SEM criterion was 3.6 points change in the FAS . CONCLUSIONS Based on the anchor-based and distribution-based methods , the MCID is a 4-point difference on the FAS . This MCID can be used in the follow-up of fatigue ( FAS ) in clinical trials and in the management of individual sarcoidosis cases",
"CONTEXT Longitudinal symptom monitoring is important in the setting of patients with advanced cancer . Scores over time may naturally fluctuate , although a patient may feel the same . OBJECTIVES The purpose of this study was to determine the minimal levels of change required to be clinical ly relevant ( minimal clinical ly important difference [ MCID ] ) using the Edmonton Symptom Assessment System ( ESAS ) . METHODS Between 1999 and 2009 , patients completed the ESAS before palliative radiotherapy and at follow-up . MCIDs were calculated using both the anchor- and distribution-based methods for improvement and deterioration ; 95 % confidence intervals for the differences in mean change scores between adjacent categories also were calculated . RESULTS A total of 276 patients completed the ESAS at baseline and during at least one follow-up visit . At the four-week follow-up , decrease of 1.2 and 1.1 units in pain and depression scales , respectively , constituted clinical ly relevant improvement , whereas increase of at least 1.4 , 1.8 , 1.1 , 1.1 , and 1.4 units , respectively , in pain , tiredness , depression , anxiety , and appetite loss items were required for deterioration . At the subsequent follow-ups , these values were similar . Overall , the MCID for improvement tended to be smaller than that for deterioration . The distribution-based method estimates tended to be larger than the 0.3 SD estimates , but closer to the 0.5 SD estimates . CONCLUSION MCIDs allow health care professionals to determine the success of treatment in improving the patient 's quality of life . MCIDs may prompt health care professionals to intervene with new treatment . Future studies should confirm our findings with a variety of anchors",
"The purpose was to determine the minimally important clinical difference ( MICD ) in fatigue as measured by the Profile of Mood States , Schwartz Cancer Fatigue Scale ( SCFS ) , General Fatigue Scale , and a 10-point single-item fatigue measure . The MICD is the smallest amount of change in a symptom ( e.g. , fatigue ) measure that signifies an important change in that symptom . Subjects rated the degree of change in their fatigue over 2 days on a Global Rating Scale . 103 patients were enrolled on this multisite prospect i ve repeated measures design . MICD was determined following established procedures at two time points . Statistically significant changes were observed for moderate and large changes in fatigue , but not for small changes . The scales were sensitive to increases in fatigue over time . The MICD , presented as mean change , for each scale and per item on each scale is : POMS = 5.6 , per item = 1.1 , SCFS = 5.0 , per item = 0.8 , GFS = 9.7 , per item = 1.0 , and the single item measure of fatigue was 2.4 points . This information may be useful in interpreting scale scores and planning studies using these measures",
"OBJECTIVE Baseline clinical and health-related quality of life ( HRQoL ) data from a phase 2 , multi-site , international , r and omized , controlled trial were analyzed to : ( 1 ) characterize the health status of patients with relapsing-remitting multiple sclerosis ( RRMS ) , ( 2 ) explore cross-sectional relationships between HRQoL and clinical measures , and ( 3 ) evaluate differences in HRQoL scores for subsequent validation as minimally important differences ( MID ) . CLINICAL TRIAL REGISTRATION www . clinical trials.gov , NCT00207727 . RESEARCH DESIGN AND METHODS Baseline clinical and HRQoL data were selected and analyzed . HRQoL question naires included the Short Form-36 ( SF-36 ) , Fatigue Severity Scale ( FSS ) , a Patient Assessment of multiple sclerosis ( MS ) Impact ( PAMSI ) , and MS-specific symptom scales for Bladder and Bowel Control , Cognition , and Sexual Satisfaction . St and ard summary statistics described the population while Pearson and Spearman correlations evaluated the baseline association between HRQoL and clinical measures . Cross-sectional estimates of MID in HRQoL scores were derived using several clinical anchors , the PAMSI , and two tests : Tukey multiple comparisons and adjacent mean difference . RESULTS Patients ( n = 249 ) had a mean age of 39.0 ( St and ard deviation , SD = 10.5 ) , 70 % were female , 63 % resided in Europe , and 96 % were Caucasian . Baseline median Exp and ed Disability Severity Scale ( EDSS ) was 2.5 ( range = 0.0 - 6.5 ) ; median disease duration was 1.9 years ( range = 0.1 - 33.6 ) . The worst baseline mean ( normalized ) SF-36 scores were for General Health ( 39.9 ) , Role Physical ( 40.4 ) , Physical Functioning ( 41.0 ) , and Vitality ( 42.7 ) . The worst MS symptom mean scores were for Cognition ( 6.3 ) and FSS ( 4.4 ) . Fatigue scores indicated substantial burden and were consistent with SF-36 Vitality results . Baseline HRQoL scores ( SF-36 , FSS , MS symptom scales ) correlated most with EDSS , Multiple Sclerosis Functional Composite ( MSFC ) , age and disease duration . Lesion count and pre-baseline relapse rate had no meaningful association with HRQoL or other clinical measures . The MID for several HRQoL measures are proposed for confirmation in longitudinal patient data sets . CONCLUSION Clinical and HRQoL assessment s documented health impairments in physical functioning , fatigue , and cognition among these RRMS patients with relatively short disease duration . HRQoL data varied with clinical measures and contributed new information regarding disease burden . The association between clinical and HRQoL measures was limited to cross-sectional analysis and requires confirmation in longitudinal data sets . These findings reflect an ambulatory , early-stage RRMS population that was mostly European in location or descent . The PAMSI also requires further validation as a measure of patient health status",
"OBJECTIVE Interpretation of data from health-related quality of life ( HRQoL ) question naires can be enhanced with the availability of minimally important difference ( MID ) estimates . This information will aid clinicians in interpreting HRQoL differences within patients over time and between treatment groups . The Immune Thrombocytopenic Purpura (ITP)-Patient Assessment Question naire ( PAQ ) is the only comprehensive HRQoL question naire available for adults with ITP . RESEARCH DESIGN AND METHODS Forty centers from within the US and Europe enrolled ITP patients into one of two multicenter , r and omized , placebo-controlled , double-blind , 6-month , phase III clinical trials of romiplostim . Patients enrolled in these studies self-administered the ITP-PAQ and two items assessing global change ( anchors ) at baseline and weeks 4 , 12 , and 24 . Using data from the ITP-PAQ and these two anchors , an anchor-based estimate was computed and combined with the st and ard error of measurement and st and ard deviation to compute a distribution-based estimate in order to provide an MID range for each of the 11 scales of the ITP-PAQ . RESULTS A total of 125 patients participated in these clinical trials and provided data for use in these analyses . Combining results from anchor- and distribution-based approaches , MID values were computed for 9 of the 11 scales . MIDs ranged from 8 to 12 points for Symptoms , Bother , Psychological , Overall QOL , Social Activity , Menstrual Symptoms , and Fertility , while the range was 10 to 15 points for the Fatigue and Activity scales of the ITP-PAQ . These estimates , while slightly higher than other published MID estimates , were consistent with moderate effect sizes . CONCLUSIONS These MID estimates will serve as a useful tool to research ers and clinicians using the ITP-PAQ , providing guidance for interpretation of baseline scores as well as changes in ITP-PAQ scores over time . Additional work should be done to finalize these initial estimates using more appropriate anchors that correlate more highly with the ITP-PAQ scales"
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4117f6ae-06ff-11f0-808a-c43d1ab1c353
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This article is a systematic review of the literature on divided attention assessment inclusive of a cognitive and motor task ( balance or gait ) for use in concussion management . The systematic review drew from published papers listed in PubMed , MEDLINE , EMBASE and CINAHL data bases . The search identified 19 empirical research papers meeting the inclusion criteria . Study results were considered for the psychometric properties of the paradigms , the influence of divided attention on measures of cognition and postural control and the comparison of divided attention task outcomes between individuals with concussion and healthy controls ( all sample s were age 17 years or older ) . The review highlights that the reliability of the tasks under a divided attention paradigm presented ranges from low to high ( ICC : 0.1–0.9 ) ; however , only 3/19 articles included psychometric information . Response times are greater , gait strategies are less efficient , and postural control deficits are greater in concussed participants compared with healthy controls both immediately and for some period following concussive injury , specifically under divided attention conditions . Dual task assessment s in some cases were more reliable than single task assessment s and may be better able to detect lingering effects following concussion . Few of the studies have been replicated and applied across various age groups . A key limitation of these studies is that many include laboratory and time-intensive measures . Future research is needed to refine a time and cost efficient divided attention assessment paradigm , and more work is needed in younger ( pre-teens ) population s where the application may be of greatest utility
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"Purpose : The main objectives of this study were to describe long-term self-reported balance problems and to explore their associations with post-concussion symptoms and performance-based tests . Method : Prospect i ve study of patients with mild traumatic brain injury ( MTBI ) . Self-reported balance problems and post-concussion symptoms were measured with the Rivermead Post-concussion Symptoms Question naire at 1 and 4 years after injury . Performance-based tests were performed 4 years after injury and included posturography , the Dynamic Gait Index ( DGI ) , walking speed tests , and the six-minute walk test . Results : Self-reported balance problems were reported in 31 % of patients 4 years after injury and correlated significantly with post-concussion symptoms . The correlations with performance-based tests varied from ρ = 0.18 to ρ = 0.70 and were strongest for the maximum walking speed test ( ρ = 0.70 ) and a dual-task test ( ρ = 0.43 ) . The DGI had a considerable ceiling effect . Conclusions : Balance problems were long-term consequences of MTBI in one third of this study sample . Self-reported balance problems correlated with post-concussion symptoms and some of the performance-based tests . Future research needs to develop and evaluate appropriate rehabilitation strategies that also address the balance problems . Implication s for Rehabilitation Balance problems may persist several years after a mild traumatic brain injury . We need to develop and evaluate appropriate rehabilitation strategies that also address the balance problems",
"Background Biomechanical measures of postural stability , while generally useful in neuroscience and physical rehabilitation research , may be limited in their ability to detect more subtle influences of attention on postural control . Approximate entropy ( ApEn ) , a regularity statistic from nonlinear dynamics , recently has demonstrated relatively good measurement precision and shown promise for detecting subtle change in postural control after cerebral concussion . Our purpose was to further explore the responsiveness of ApEn by using it to evaluate the immediate , short-term effect of secondary cognitive task performance on postural control in healthy , young adults . Methods Thirty healthy , young adults performed a modified version of the Sensory Organization Test featuring single ( posture only ) and dual ( posture plus cognitive ) task trials . ApEn values , root mean square ( RMS ) displacement , and equilibrium scores ( ES ) were calculated from anterior-posterior ( AP ) and medial-lateral ( ML ) center of pressure ( COP ) component time series . For each sensory condition , we compared the ability of the postural control parameters to detect an effect of cognitive task performance . Results COP AP time series generally became more r and om ( higher ApEn value ) during dual task performance , result ing in a main effect of cognitive task ( p = 0.004 ) . In contrast , there was no significant effect of cognitive task for ApEn values of COP ML time series , RMS displacement ( AP or ML ) or ES . Conclusion During dual task performance , ApEn revealed a change in the r and omness of COP oscillations that occurred in a variety of sensory conditions , independent of changes in the amplitude of COP oscillations . The finding exp and s current support for the potential of ApEn to detect subtle changes in postural control . Implication s for future studies of attention in neuroscience and physical rehabilitation are discussed",
"PURPOSE Athletic performance dem and s simultaneous use of cognitive and postural control capabilities . Decrements to both systems have been observed following concussion . This study evaluated a dual-task methodology to establish the tenability of using this testing model in concussed athletes . METHODS Nonconcussed subjects were assessed over 2 d. Subjects were introduced to the task-switching cognitive assessment test and a NeuroCom Smart Balance Master postural control assessment protocol on day 1 . In the following session , subjects were evaluated on postural control and cognitive function tests independently ( single task ) , and then concurrently ( dual task ) . RESULTS Significant improvements were seen in three of the four balance conditions and in three of the four reaction times when the cognitive and balance task were performed simultaneously ( P balance by cognitive task interaction was revealed ( P>0.05 ) ; however , significant differences existed in reaction time based on stimulus position and increasing balance dem and s ( P healthy subjects showing improved performance when compared with individual task performance . The dual-task methodology brought about systematic changes to reaction time in relation to increasing balance dem and s. The ability of this protocol to detect changes in postural control or cognitive function following concussive injury requires further study",
"Objective : To determine if serial administration of the St and ardized Assessment of Concussion ( SAC ) and Balance Error Scoring System ( BESS ) would elicit a learning effect in young athletes and to determine the intratester reliability of scoring the BESS . Design : A prospect i ve study of 50 healthy young athletes who were assigned to either the control or practice group . All subjects were administered the assessment s on 2 occasions , 60 days apart . In addition , subjects in the practice group received serial administration of the assessment s on 3 occasions in the week following the initial assessment . Setting : University Sports Medicine/Athletic Training Research Laboratory . Subjects : Fifty uninjured young athletes between 9 and 14 years of age . Main Outcome Measured : Scores on 2 clinical concussion assessment s , the SAC and the BESS . Results : We found a significant learning effect upon serial BESS testing in the practice group . BESS error scores were significantly lower than baseline ( 15.0 ± 4.6 ) on days 5 ( 11.3 ± 5.33 ) , 7 ( 12.4 ± 6.2 ) , and 60 ( 12.6 ± 6.2 ) . We also found a significant learning effect upon the day 60 BESS administration across all subjects . We did not find a practice or learning effect with serial SAC test administration . The intratester reliability of the investigator ’s ability to score repeated observations of the same BESS test ranged from 0.87 to 0.98 . Conclusions : Our results demonstrated that serial administration of the BESS elicited a learning effect , which was more prominent during the t and em conditions . Clinicians utilizing the BESS as a measure of postural stability should be aware of the potential for improvement with repeated testing . Clinicians should not expect improvement with the SAC , as scores remained relatively stable across all trials",
"PURPOSE The objective of this study is to determine the stability and sensitivity of a dual-task ( DT ) methodology that can be used to assess the effects of concussion in athletes . METHODS Fifty-nine healthy young adults ( Mage = 20.32 ± 1.84 yr , 19 males ) who volunteered to participate completed auditory switch tasks that varied in length ( 30 , 40 , and 60 items ) at baseline , 1 wk later , and approximately 7 months later . During sessions 2 and 3 , the participants completed one of three switch tasks while concurrently performing a modified Harvard Step Test . Global switch cost indices and percentage error were calculated for each switch task . The stability reliability of the global switch cost indices was assessed under single-task conditions , and the sensitivity of the global switch costs to interference effects was assessed under DT conditions . RESULTS The stability reliability was 0.64 , 0.84 , and 0.83 for the 30- , 40- , and 60-item tests , respectively . ANOVA revealed a main effect for condition ( single task vs DT ) for both global switch costs ( F(1,55 ) = 44.53 , P and percentage error ( F(1,56 ) = 64.69 , P magnitude of the global switch cost interference effects was nearly identical across the three DT conditions . CONCLUSIONS The current concussion testing models test athletes ' cognitive and physical function in isolation . The stability reliability of the global switch cost index obtained under DT conditions suggests that it may be a useful measure for clinicians . The DT paradigm presents another test methodology that may be useful for making return-to-play decisions as part of a comprehensive concussion management plan",
"OBJECTIVE The purpose of this study was to determine the intrarater and interrater reliability of the Balance Error Scoring System ( BESS ) . DESIGN A prospect i ve observational study . SETTING Academic sports medicine center . PARTICIPANTS Three scorers participated in this study . METHODS Three scorers experienced in using the BESS viewed a videotape depicting 30 consecutive individuals performing the BESS stance positions . The 3 scorers independently scored each of the 30 videotaped individuals using the BESS scoring criteria . A week later , the same 3 subjects viewed and scored the videotape again . MAIN OUTCOME MEASUREMENTS The interrater and intrarater reliability of the BESS was determined using intraclass correlation coefficients ( ICC ) , reported with 95 % confidence intervals . The minimum detectible change was also determined . RESULTS The interrater and intrarater reliability ICCs for the total BESS scores were 0.57 and 0.74 , respectively . The interrater reliability ICCs for the 6 different stance positions were between 0.44 and 0.83 , while the intrarater reliability ICCs were between 0.50 and 0.88 . The interrater and intrarater minimum detectible change for the total BESS score were 9.4 and 7.3 points , respectively . CONCLUSION This study suggests that certain subcategories of the BESS have sufficient reliability to be used in the evaluation of postural stability but that the total BESS score is not reliable . In addition , a change in score of greater than 9.4 ( interrater ) or 7.3 ( intrarater ) points is required before the change in postural stability can be attributed to the balancer rather than to the scorer",
"OBJECTIVES To determine the reliability and effects of a dual-task paradigm on balance and cognitive function compared to a single-task paradigm . DESIGN Repeated measures . METHODS Healthy participants ( n=23 ) completed a variation of the Sensory Organization Test and the incongruent Stroop test individually ( single-task ) and concurrently ( dual-task ) during two testing sessions . RESULTS The Sensory Organization Test and incongruent Stroop test had moderate to high reliability ( 1.00>ICC2,k>0.60 ) under the dual-task conditions . Reaction time was significantly longer ( t21=-2.54 , p=0.019 ) under the dual-task conditions , while balance scores under one of the four conditions of the Sensory Organization Test ( sway floor/fixed wall ) were statistically better ( t22=-3.03 , p=0.006 ) under the dual-task conditions . However , this difference in balance scores may not be clinical ly meaningful . CONCLUSIONS These findings illustrate that the Sensory Organization Test and incongruent Stroop task can be reliably incorporated into a dual-task assessment paradigm . The slowed reaction time under the dual-task paradigm indicates that the dual-task provided an additional cost to cognitive function . Dual-task concussion assessment paradigms involving these two tasks are psychometrically appropriate as well as more representative of actual sporting situations . However , more research should be conducted in a concussed population to further vali date this cl aim",
"BACKGROUND The need to identify functional impairment following a brain injury is critical to prevent re-injury during the period of recovery . While many neuropsychological tests have been developed to assess cognitive performance , relatively little information on gait and dynamic stability is available on motor task performance for young adults following concussion . This study was performed to investigate the effect of divided attention following concussion on various gait variables . It was hypothesized that , when compared to uninjured controls , concussed subjects would demonstrate deficits in maintenance of dynamic stability . METHODS Ten subjects with Grade 2 concussion completed testing within 48 h of injury as well as 10 age- , height- , weight- , and activity-matched controls . The gait protocol consisted of level walking under two conditions : ( 1 ) undivided attention ( single-task ) and ( 2 ) while simultaneously completing simple mental tasks ( dual-task ) . Whole-body motion data were collected using a six-camera motion analysis system . A 13-segment biomechanical model was used to compute whole body center of mass motion and velocity . FINDINGS Walking with a concurrent cognitive task result ed in significant changes in gait and center of mass measurements for both groups . Concussed subjects were found to be able to conservatively adjust their whole body center of mass motion to maintain dynamic stability while walking without divided attention . However , while walking with divided attention , subjects with concussion demonstrated a significantly greater medio-lateral center of mass sway . INTERPRETATION These data suggest that the ability to control and maintain stability in the frontal plane during walking is diminished under divided attention in individuals following a concussion"
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Purpose To clarify the efficacy of phosphodiesterase-5 inhibitors ( PDE5Is ) and selective serotonin reuptake inhibitors ( SSRIs ) in men with premature ejaculation ( PE ) . Methods We search ed the PubMed , Embase , and Cochrane Library data bases to identify all r and omized , controlled trials ( RCTs ) and compared the results , including intravaginal ejaculation latency time , satisfaction , intercourse per-week and side effects after treatment with PDE5I or SSRIs versus placebo , combined use of PDE5I with SSRIs versus PDE5I or SSRIs alone , and PDE5I versus SSRIs for treating PE . Results The study inclusion criteria were met by 23 studies ( ten RCTs with five crossover studies ) involving 6145 patients . The data synthesized from these studies indicated that the efficacy of PDE5Is and SSRIs was better than that of placebo ( p side effects while taking PDE5Is and SSRIs ( p efficacy of the combined treatment was significantly better than that of PDE5Is or SSRIs alone ( p side effects from the combined treatment than from SSRIs ( p = 0.0002 ) , with no significant difference in PDE5Is ( p = 0.5 ) . The efficacy of PDE5Is was better than that of SSRIs ( p = 0.006 ) , and no significant difference was observed in the frequency of side effects ( p = 0.93 ) . Conclusions PDE5Is were significantly more effective than placebo or SSRIs for treating PE , while SSRIs were better than placebo . The combined treatment had better efficacy than PDE5Is or SSRIs alone
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"Abstract Objectives : To compare the clinical efficacy of the on-dem and use of four drugs in the management of patients with premature ejaculation ( PE ) , as the off-label use of selective serotonin-reuptake inhibitors and topical penile anaesthetics is frequently indicated for the management of patients with PE , and tramadol HCl and sildenafil citrate were also tried for managing this disorder , but with recommendations based on weak evidence . Patients and methods : This was a single-centre , single-blind , placebo-controlled clinical trial conducted on 150 patients who had PE for > 1 year . Patients were r and omised equally into five groups . On-dem and tramadol , sildenafil , paroxetine , local lidocaine gel or placebo was given for patients in groups 1–5 , respectively . During the month before treatment , the intravaginal ejaculation latency time ( IELT ) and sexual satisfaction scores ( on a 0–5-point scale ) were measured and compared to the mean IELT and sexual satisfaction scores recorded during 4 weeks of on-dem and drug administration , with monitoring of any possible side-effects . Results : Tramadol-treated patients had a significantly longer mean ( SD ) IELT , of 351 ( 119 ) s , than the other groups . Local anaesthetic was significantly better than paroxetine in prolonging the IELT , at 278 ( 111 ) vs. 186 ( 65 ) s , respectively . The improvement in sexual satisfaction was significantly better in the sildenafil group , with a mean ( SD ) improvement of 2.9 ( 1 ) points , than in the paroxetine and local anaesthetic groups , at 2.2 ( 0.9 ) and 1.9 ( 0.9 ) points , respectively . Conclusions : The four drugs significantly improved IELT values over placebo . Tramadol was associated with significantly longer IELT values , whilst sildenafil induced significantly better sexual satisfaction than the other drugs . The four drugs had tolerable side-effects",
"BACKGROUND No drugs are approved for treatment of premature ejaculation . Our aim was to determine the efficacy and tolerability of on-dem and dapoxetine in patients with severe premature ejaculation . METHODS We determined the efficacy of dapoxetine in a prospect ively predefined integrated analysis of two 12-week r and omised , double-blind , placebo-controlled , phase III trials of identical design done independently , in parallel , at 121 sites in the USA . Men with moderate-to-severe premature ejaculation in stable , heterosexual relationships took placebo ( n=870 ) , 30 mg dapoxetine ( 874 ) , or 60 mg dapoxetine ( 870 ) on-dem and ( as needed , 1 - 3 h before anticipated sexual activity ) . The primary endpoint was intravaginal ejaculatory latency time ( IELT ) measured by stopwatch . Safety and tolerability were assessed . All analyses were done on an intention-to-treat basis . The trials are registered at Clinical Trials.gov , numbers NCT00211107 and NCT00211094 . FINDINGS 672 , 676 , and 610 patients completed in the placebo , 30 mg dapoxetine , and 60 mg dapoxetine groups , respectively . Dapoxetine significantly prolonged IELT ( p Mean IELT at baseline was 0.90 ( SD 0.47 ) minute , 0.92 ( 0.50 ) minute , and 0.91 ( 0.48 ) minute , and at study endpoint ( week 12 or final visit ) was 1.75 ( 2.21 ) minutes for placebo , 2.78 ( 3.48 ) minutes for 30 mg dapoxetine , and 3.32 ( 3.68 ) minutes for 60 mg dapoxetine . Both dapoxetine doses were effective on the first dose . Common adverse events ( 30 mg and 60 mg dapoxetine , respectively ) were nausea ( 8.7 % , 20.1 % ) , diarrhoea ( 3.9 % , 6.8 % ) , headache ( 5.9 % , 6.8 % ) , and dizziness ( 3.0 % , 6.2 % ) . INTERPRETATION On-dem and dapoxetine is an effective and generally well tolerated treatment for men with moderate-to-severe premature ejaculation",
"PURPOSE Fluoxetine , a selective serotonin re-uptake inhibitor , has been shown to increase the intravaginal latency of patients with premature ejaculation . We demonstrated the effects of fluoxetine on intravaginal latency , penile sensory threshold , and variables of sacral evoked response and cortical somatosensorial evoked potential in patients with premature ejaculation . MATERIAL S AND METHODS Of 48 patients 40 who presented to our clinic with premature ejaculation met the study criteria , gave written or oral consent , and were divided r and omly in a double-blind fashion into 2 groups of 20 patients . The study group received 20 mg . fluoxetine daily and the control group received placebo for 1 month . The patients were evaluated during visits before and after treatment for intravaginal latency , penile sensory threshold values , and the variables of sacral evoked response and cortical somatosensory evoked potential tests . RESULTS Patient ages , intravaginal latencies , penile sensory threshold values , and amplitudes and latencies of sacral evoked response and cortical somatosensory evoked potential tests in both groups were not significantly different at the beginning of treatment ( p > 0.05 ) . At the end of treatment intravaginal latencies and penile sensory threshold values were increased in the study group compared to before treatment and the control group ( p amplitudes and latencies of sacral evoked response and cortical somatosensory evoked potential tests ( p > 0.05 ) . CONCLUSIONS These findings suggest that fluoxetine is effective treatment for premature ejaculation probably due to its effect of increasing the penile sensory threshold , without changing the amplitudes and latencies of sacral evoked response and cortical somatosensory evoked potential",
"BACKGROUND Dapoxetine is being developed for the on-dem and treatment of premature ejaculation ( PE ) . Previous clinical trials have demonstrated its safety and efficacy . OBJECTIVE To evaluate the long-term efficacy and safety of dapoxetine in men with PE . DESIGN , SETTING , AND PARTICIPANTS This r and omized , double-blind , parallel-group , placebo-controlled , phase 3 trial , conducted in 22 countries , enrolled men ( N=1162 ) > or = 18 yr of age who met the Diagnostic and Statistical Manual of Mental Disorders , fourth edition , text revision criteria for PE for > or = 6 mo , with an intravaginal ejaculatory latency time ( IELT ) or = 75 % of intercourse episodes at baseline . INTERVENTION Dapoxetine 30 mg or dapoxetine 60 mg or placebo on dem and ( 1 - 3 h before intercourse ) for 24 wk . MEASUREMENTS Stopwatch-measured IELT , Premature Ejaculation Profile ( PEP ) , Clinical Global Impression ( CGI ) of change , adverse events ( AEs ) . RESULTS AND LIMITATIONS The study was completed by 618 men . Mean average IELT increased from 0.9 min at baseline ( all groups ) to 1.9 min , 3.2 min , and 3.5 min with placebo and dapoxetine 30 mg and dapoxetine 60 mg , respectively , at study end point ; geometric mean IELT increased from 0.7 min at baseline to 1.1 min , 1.8 min , and 2.3 min , respectively , at study end point . All PEP measures and IELTs improved significantly with dapoxetine versus placebo at week 12 and week 24 ( p nausea , dizziness , diarrhea , and headache . AEs led to discontinuation in 1.3 % , 3.9 % , and 8.2 % of subjects with placebo and dapoxetine 30 mg and dapoxetine 60 mg , respectively . Limitations of this study included the exclusion of men who were not in long-term monogamous relationships . CONCLUSIONS Dapoxetine significantly improved all aspects of PE and was generally well tolerated in this broad population",
"Background : Several recent studies have investigated the therapeutic role of phosphodiesterase type 5 ( PDE5 ) inhibitors in premature ejaculation ( PE ) used in the treatment of erectile dysfunction . Objectives : In the present research , the efficacy of paroxetine alone and paroxetine plus tadalafil was compared in patients referred because of premature ejaculation . Patients and Methods : This quasi-experimental study was performed on 100 consecutive 17 to 49-year-old potent men with premature ejaculation and without any clear organic disease . All patients had lifelong PE with an intravaginal ejaculation latency time ( IELT ) shorter than 1.5 minutes . Informed consent was obtained from all patients who were r and omly divided into two groups using a computer-generated r and om tabulation list . In group A , patients received 10 mg paroxetine daily , in addition to four hours before planned sexual activity . In group B , 10 mg paroxetine was taken daily , plus 10 mg tadalafil one hour before planned sexual activity . The duration of the intervention was six months and patients were evaluated for IELT three and six months after the beginning of therapy . Results : The mean age of patients in groups A and B were 33 ± 9.6 and 31.2 ± 9.3 years , respectively ( P = 0.368 ) . The mean number of intercourses were 1.08 ± 0.6 and 1.12 ± 0.6 per week in groups A and B , respectively ( P = 0.791 ) . Mean IELT at the 3-month follow up in groups A and B was 4.5 ± 1.5 and 5 ± 2.4 minutes , respectively ( P = 0.285 ) and at the 6-month follow up was 4.8 ± 1 and 5.3 ± 2 minutes , respectively ( P = 0.278 ) . Conclusions : The results of the study show that tadalafil can increase the mean IELT and can be used for treatment of premature ejaculation in combination with paroxetine",
"Depression is a common cause of sexual dysfunction , but also antidepressant medication is often associated with sexual side effects . This article includes two related studies . The first double-blind , placebo-controlled study was conducted in men with lifelong rapid ejaculation and aim ed to assess putative differences between the major selective serotonin reuptake inhibitors ( SSRIs ) ( fluoxetine , fluvoxamine , paroxetine , and sertraline ) with regard to their ejaculation-delaying effect . Sixty men with an intravaginal ejaculation latency time ( IELT ) of 1 minute or less were r and omly assigned to receive fluoxetine 20 mg/day , fluvoxamine 100 mg/day , paroxetine 20 mg/day , sertraline 50 mg/day , or placebo for 6 weeks . During the 1-month baseline and 6-week treatment periods , the men measured their IELT at home using a stopwatch . The trial was completed by 51 men . During the 6-week treatment period , the geometric mean IELT in the placebo group was constant at approximately 20 seconds . Analysis of variance revealed a between-groups difference in the evolution of IELT delay ( p = 0.0004 ) ; in the paroxetine , fluoxetine , and sertraline groups there was a gradual increase to about 110 seconds , whereas in the fluvoxamine group , IELT was increased to only approximately 40 seconds . The paroxetine , fluoxetine , and sertraline groups differed significantly ( p placebo but the fluvoxamine group did not ( p = 0.38 ) . Compared with baseline , paroxetine exerted the strongest delay in ejaculation , followed by fluoxetine and sertraline . There was no clinical ly relevant delay in ejaculation with fluvoxamine . In men with lifelong rapid ejaculation , paroxetine delayed ejaculation most strongly , whereas fluvoxamine delayed ejaculation the least . The second double-blind , placebo-controlled study was carried out in men with lifelong rapid ejaculation ( IELT 1 minute ) to investigate whether data about SSRI-induced delayed ejaculation in men with rapid ejaculation may be extrapolated to men with less-rapid ejaculation . After measurement of IELT at home ( using a stopwatch ) during a 1-month baseline assessment , 32 men with an IELT of 1 minute or less ( group 1 ) or more than 1 minute ( group 2 ) were r and omly assigned to receive paroxetine 20 mg/day or placebo for 6 weeks in a double-blind manner . Patients continued to measure their IELTs at home during the 6 weeks of the study . At baseline , 24 patients consistently had IELTs of one minute or less ( group 1 ) , and eight patients had IELTs of more than 1 minute ( group 2 ) . The geometric mean IELT was 14 seconds in group 1 and 83 seconds in group 2 . Twelve patients in group 1 and five in group 2 were r and omized to the paroxetine 20 mg/day . The percentage increase in the geometric mean IELT compared with baseline in patients treated with paroxetine was 420 % ( 95 % confidence interval [ CI ] , 216 - 758 % ) in group 1 and 480 % ( 95 % CI , 177 - 1,118 % ) in group 2 ( p = 0.81 ) . After 6 weeks of treatment with paroxetine , the geometric mean IELT was 92 seconds in group 1 and 602 seconds in group 2 ( p paroxetine-induced percentage increase in IELT seems to be independent of the baseline IELT . This suggests that ejaculation-delaying side effects of some SSRIs investigated in men with lifelong rapid ejaculation may be generalized to men with less-rapid ejaculation",
"PURPOSE We evaluate the efficacy of paroxetine hydrochloride as needed for the treatment of premature ejaculation . MATERIAL S AND METHOD Study 1 comprised 26 potent men with a mean age of 39.5 years with premature ejaculation who were r and omized to receive 20 mg . oral paroxetine ( group A ) or placebo ( group B ) as needed 3 to 4 hours before planned intercourse in a controlled single-blind crossover trial . Study 2 comprised 42 potent men with a mean age of 40.5 years with premature ejaculation who were r and omized to receive 10 mg . paroxetine daily for 3 weeks and then 20 mg . paroxetine as needed ( group C ) for 4 weeks or placebo daily for 3 weeks and then placebo as needed ( group D ) for 4 weeks . RESULTS Mean pretreatment ejaculatory latency time was 0.3 minute for study 1 . At 4 weeks mean ejaculatory latency time was 3.2 minutes in the paroxetine as needed and 0.45 in the placebo as needed phase for group A ( p placebo as needed and 3.5 in the paroxetine as needed phase for group B ( p adverse effects with paroxetine or placebo in study 1 . Mean pretreatment ejaculatory latency time was 0.5 minute for study 2 . At 3 weeks mean ejaculatory latency time was 4.3 minutes in the paroxetine daily and 5.8 in the paroxetine as needed phase , and 0.9 in the placebo daily and 0.6 in the placebo as needed phase for group C ( p ejaculatory latency time was 0.8 minutes in the placebo daily and 1.1 in the placebo as needed phase , and 3.3 in the paroxetine daily and 6.1 in the paroxetine as needed phase for group D ( p Adverse effects in 7 of 42 men ( 17 % ) given paroxetine daily included an ejaculation in 3 , anorexia in 1 , gastrointestinal upset in 3 and reduced libido in 2 . Mean ejaculatory latency time was greater in the paroxetine as needed phase of study 2 than that of study 1 ( p paroxetine as needed is significantly better if patients are initially treated with the drug daily . CONCLUSIONS Paroxetine appears to be superior to placebo in the pharmacological treatment of premature ejaculation when administered on a chronic or as needed basis",
"To evaluate the overall treatment benefit of dapoxetine for premature ejaculation ( PE ) , with specific emphasis on improvements in personal distress and interpersonal difficulty related to ejaculation . Although these factors are key elements of numerous sets of diagnostic criteria for PE , they have rarely been evaluated as outcome measures in clinical trials",
"We investigated safety and efficacy of vardenafil and sertraline in premature ejaculation ( PE ) . Seventy‐two men grade d their primary PE on a scale of 0–8 ( 0 = almost never , 8 = almost always ) . Intravaginal ejaculatory latency time ( IELT ) was measured . Patients were included if they scored their PE as 4 or greater and their IELTs were less than 1.30 min . After 6 weeks of behavioural psychosexual therapy , 49 patients still had a PE of 4 or greater and an IELT less than 1.30 min and they were r and omised : 6 weeks vardenafil ( 10 mg ) or sertraline ( 50 mg ) . After a wash‐out phase for 1 week , medication was changed in a cross‐over design . Initially , all 72 men with PE received behavioural therapy . Twenty‐three men were satisfied with treatment and excluded . The remaining 49 men grade d their PE as 5.94 ± 1.6 and IELT was 0.59 min and patients were r and omised . Four men discontinued the study . Vardenafil improved PE grading : 2.7 ± 2.1 ( P increased to 5.01 ± 3.69 ( P grading improved 1.92 ± 1.32 , ( P IELT 3.12 ± 1.89 ( P 0.001 ) with sertraline . It is concluded that vardenafil and sertraline are useful agents in the pharmacological treatment of PE ",
"INTRODUCTION There is partial evidence to support the use of phophodiesterase-5 inhibitor ( PDE5-I ) for the treatment of premature ejaculation ( PE ) . AIM We compared on-dem and dosing of dapoxetine alone and combined with mirodenafil in subjects with lifelong PE and without erectile dysfunction ( ED ) . METHODS Our prospect i ve , r and omized , double-blind , placebo-controlled , multicenter trial enrolled 118 subjects with lifelong PE without ED . PE was diagnosed using Diagnostic and Statistical Manual of Mental Disorders , fourth edition , text revision . Patients were divided into two groups : dapoxetine 30 mg plus placebo ( group A , n=56 ) and dapoxetine 30 mg plus mirodenafil 50 mg ( group B , n=62 ) . MAIN OUTCOME MEASURES During 12 weeks , intravaginal ejaculatory latency time ( IELT ) and the time from foreplay to beginning intercourse ( FTIT ) with a stopwatch , and Premature Ejaculation Profile ( PEP ) were measured . Overall sexual act time ( OSAT ; sum of FTIT and IELT ) was calculated . Any treatment-emergent adverse events ( TEAEs ) were also recorded . RESULTS Over 12 weeks , IELT , OSAT , and PEP index score significantly improved in group B compared with group A ( increased geometric mean IELT in group A and B=3.6 and 6.1 minutes , P=0.026 ; increased geometric mean OSAT in group A and B=5.5 and 9.9 minutes , P=0.012 ; increased median PEP index score in group A and B=1.0 and 1.3 , P=0.046 ) . However , there was no significant difference between two groups with respect to improvement of FTIT ( P=0.147 ) . TEAEs did not differ between groups ( all P>0.05 ) , and there was no serious adverse event in any subjects . CONCLUSIONS Low dose of dapoxetine combined with mirodenafil showed better results in terms of IELT , OSAT , and PEP index score , and similar TEAEs , compared with that of dapoxetine only . Our results support the suggestion that the PDE5-Is have a potential role in the treatment of PE without ED",
"Antidepressant medication is often associated with sexual side effects . A double-blind , placebo-controlled study in men with lifelong rapid ejaculation was performed to assess the effects of two selective serotonin ( 5-HT ) reuptake inhibitors — paroxetine and sertraline— and the 5-HT 2 antagonist and 5-HT/noradrenaline reuptake inhibitor nefazodone on the latency to ejaculate . Forty-eight men with an intravaginal ejaculation latency time ( IELT ) of a maximum of 1 minute were r and omly assigned to receive paroxetine ( 20 mg/day ) , sertraline ( 50 mg/day ) , nefazodone ( 400 mg/day ) , or placebo for 6 weeks . During the 1-month baseline and 6-week treatment period , IELTs were measured at home with a stopwatch . The trial was completed by 40 men . During the 6-week treatment period , the geometric mean IELT in the placebo group was stable at approximately 20 seconds . Analysis of variance revealed a between-group difference in the evolution of IELT delay over time ( p = 0.002 ) ; the IELT after paroxetine and sertraline gradually increased to approximately 146 and 58 seconds , respectively , compared with 28 seconds in the nefazodone group . The paroxetine and sertraline groups differed significantly ( p placebo , but the nefazodone group did not ( p = 0.85 ) . Compared with baseline , paroxetine exerted the strongest delay in ejaculation , whereas sertraline delayed it only moderately . There was no clinical ly relevant delay in ejaculation with nefazodone",
"INTRODUCTION Men with comorbid erectile dysfunction ( ED ) and premature ejaculation ( PE ) may be concomitantly prescribed a phosphodiesterase type 5 ( PDE5 ) inhibitor and dapoxetine . AIM Evaluate efficacy and safety of dapoxetine 30 mg and 60 mg on dem and ( prn ) in men with PE and ED who were being treated with PDE5 inhibitors . METHODS This r and omized , double-blind , placebo-controlled , flexible-dose , multicenter study enrolled men ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time ( IELT ) of ≤2 minutes in ≥75 % of sexual intercourse episodes ; were on stable regimen of a PDE5 inhibitor ; and had International Index of Erectile Function-erectile function domain score ≥21 . Subjects received placebo , dapoxetine 30 mg , or dapoxetine 60 mg prn ( 1 - 3 hours before intercourse ) for 12 weeks . MAIN OUTCOME MEASURE Stopwatch-measured average IELT , Clinical Global Impression of Change ( CGIC ) in PE , Premature Ejaculation Profile ( PEP ) , and treatment-emergent adverse events ( TEAEs ) . RESULTS Of 495 subjects r and omized , 429 completed the study . Arithmetic mean average IELT significantly increased with dapoxetine vs. placebo at end point ( 5.2 vs. 3.4 minutes ) and weeks 4 , 8 , and 12 ( P ≤ 0.002 for all ) . Men who described their PE at least \" better \" using the CGIC were significantly greater with dapoxetine vs. placebo at end point ( 56.5 % vs. 35.4 % ) and weeks 4 , 8 , and 12 ( P ≤ 0.001 for all ) . Significantly better outcomes were also reported with dapoxetine vs. placebo on PEP measures . Incidence of TEAEs was 20.0 % and 29.6 % in placebo- and dapoxetine-treated subjects , respectively ( P = 0.0135 ) . TEAEs led to discontinuation in 1.6 % of subjects in both groups . Most frequent TEAEs were known adverse drug reactions of dapoxetine treatment including nausea ( 9.2 % ) , headache ( 4.4 % ) , diarrhea ( 3.6 % ) , dizziness ( 2.4 % ) , and dizziness postural ( 2.4 % ) . CONCLUSIONS In men with PE and comorbid ED on a stable regimen of PDE5 inhibitor , dapoxetine provided meaningful treatment benefit and was generally well tolerated",
"OBJECTIVES To compare the efficacy of sildenafil ( Viagra ) only , sildenafil plus topical anesthetic cream ( EMLA ) , and topical EMLA-cream-only to that of placebo in treating premature ejaculation . METHODS A total of 84 patients were enrolled in this study . The duration of premature ejaculation in the patients ranged from 9 to 60 months ( mean 32.5 + /- 14.6 ) . Patients were r and omized into four groups . Group 1 consisted of 20 patients who took placebo for 2 months . Groups 2 and 3 consisted of 20 and 22 patients , respectively , and they received 50 mg sildenafil 45 minutes before coitus for 2 months . In addition , patients in group 3 applied topical EMLA cream to the glans penis 15 minutes before coitus . The 22 patients in group 4 used topical EMLA-cream-only . After at least eight sexual attempts , the patients ' clinical responses were assessed using the patient self-description method . Effectiveness was described as improvement plus cure . RESULTS The effectiveness was 40 % in group 1 , 55 % in group 2 , 86.4 % in group 3 , and 77.3 % in group 4 . Of the groups , a significant difference was found in the effectiveness of the treatments ( Pearson chi-square= 0.00 ) . No significant difference was found between groups 1 and 2 ( P = 0.26 ) . Efficacy was more successful in groups 3 and 4 than in the others ( P = 0.00 ) . The difference between groups 3 and 4 was not significant ( Pearson chi-square = 0.42 ) . CONCLUSIONS Sildenafil-only was not superior to placebo or combination treatment . Topical EMLA-cream-only had equal effectiveness to that of sildenafil plus topical EMLA treatment . The use of topical EMLA-cream-only seems to be an effective treatment of premature ejaculation",
"This study investigated the efficacy and the adverse effects of sertraline in the treatment of premature ejaculation ( PE ) . Thirty-seven patients with PE were r and omly assigned to receive either sertraline or a placebo . Of them 22 were given 50 mg of sertraline per day and the other 15 patients were given an identical placebo one per day . After 4 weeks , the latency to ejaculation in the sertraline group was found to be significantly longer than that of the placebo group ( p adverse effects . These results indicate that sertraline is an effective therapy for PE ",
"We aim ed to evaluate the effectiveness of paroxetine and tadalafil combination in the treatment of premature ejaculation ( PE ) . A total of 150 primary (lifelong)PE patients were r and omly distributed into three groups of 50 patients each . Group 1 received 20 mg paroxetine every day for 1 month , Group 2 received 20 mg tadalafil on dem and 2 h before intercourse , and Group 3 received paroxetine and tadalafil on dem and 2 h before intercourse . Intravaginal ejaculatory latency times ( IELT ) scores were evaluated at baseline , at the end of the first month of therapy and 1 month after discontinuation of the treatment , while International Index of Erectile Function ( IIEF ) question naire scores were evaluated both prior to and after the treatment . At the end of the first month of therapy , IELT scores were compared with the basal values and statistically significant changes were detected ( 60.6 ± 30.2–117.3 ± 67.3 , 68.5 ± 21.4–110.2 ± 37.3 , 71.56 ± 40.23–175.2 ± 60.2)(P discontinuation of treatment were found to be close to the baseline IELT scores ( P > 0.05 ) . IIEF scores were evaluated both prior to and after the treatment , and no statistically significant difference was detected ( P > 0.05 ) . It is concluded that utilisation of selective serotonin reuptake inhibitors ( SSRI ) and phosphodiesterase‐5 inhibitors ( PDE5i ) combination before intercourse seems to provide significantly longer ejaculatory latency times as compared with SSRI alone for a long time in patients with PE",
"Objective The aim of this study is to measure the ejaculation latency time ( ELT ) and to evaluate the effects of vardenafil on ELT and rigidity parameters of patients with lifelong premature ejaculation ( PE ) in a laboratory setting . Material s and methods Double-blind , placebo-controlled , cross-over laboratory study was performed with 40 males with lifelong PE . As the subject ingested the placebo or vardenafil , real-time penile tumescence and rigidity monitoring began . Audiovisual sexual stimulation ( AVSS ) was performed 45 min later . The patient began vibratory stimulation to the frenular area at 8th minute of AVSS till ejaculation . A button has been placed under the cover where the patient presses to operate the vibrator . ELT was calculated in seconds with a chronometer . Following ejaculation , AVSS was stopped . The test was repeated with second medication in 7–15 days . Results Among 40 patients , the results of 17 could be evaluated . When the patient took placebo and vardenafil , mean ELTs were 62.7 and 189.5 s , respectively . When compared with placebo , vardenafil improved ELT significantly ( P = 0.04 ) . After the beginning of AVSS , time to first recorded base or tip rigidities was shorter and time to last recorded tip or base rigidities following ejaculation was longer than placebo ; however , these differences were not significant ( P > 0.05 for each ) . Conclusions This laboratory design might be used to evaluate the effects of drugs on patients with ejaculation disorders . In this laboratory setting study , vardenafil exerted a threefold increase in ejaculation delay outside the vagina in patients with lifelong PE ",
"Introduction : Premature ejaculation ( PE ) is a common male sexual disorder . An ideal , reliable and effective treatment is desired by many men and couples affected by this condition . Aim : Evaluate if the association of a phosphodiesterase-5 inhibitor , tadalafil , and a selective serotonin reuptake inhibitor , fluoxetine , can prolong the intravaginal ejaculatory latency time ( IELT ) in men with lifelong premature ejaculation . Methods : Sixty patients with lifelong premature ejaculation and without erectile dysfunction ( ED ) with IELT less than 90 s were enrolled in the protocol and r and omized into 4 groups to use a combination of medications : ( 1 ) tadalafil 20 mg plus fluoxetine 90 mg , ( 2 ) fluoxetine 90 mg plus placebo , ( 3 ) tadalafil 20 mg plus placebo , and ( 4 ) two different placebo capsules ( control ) . Before starting the medications , each man timed his IELT with a stopwatch , and likewise during the treatment period . Fluoxetine 90 mg or placebo was taken once a week plus tadalafil 20 mg or placebo within a 36-hour frame of intended sexual intercourse with a steady partner . Patients were prospect ively followed for 12 weeks . One-way ANOVA was used for statistical comparisons of IELT results in each group . Results : Mean IELT before starting treatment was 51.3 ± 23 s. Withone-way ANOVA , a statistically significant difference in post-treatment IELT was seen with combination treatment compared to placebo ( p increases in IELT from baseline in patients using fluoxetine plus tadalafil ( 49.57 ± 25.87 to 336.13 ± 224.77 ) ( p tadalafil ( 49.26 ± 19.43 to 186.53 ± 159.05 ) ( p = 0.001 ) . The increases in each group were statistically significant compared to the placebo ( 49.86 ± 19.43 to 67.82 ± 46.18 ) ( p = 0.042 ) . Conclusion : Fluoxetine plus tadalafil significantly increased the IELT from baseline in men with lifelong premature ejaculation when compared to placebo , tadalafil or fluoxetine",
"Introduction : The aim of this study was to compare the efficacy of fluoxetine alone and combined with sildenafil in patients complaining of premature ejaculation . Patients and Methods : Ninety-one married potent men , 21–43 years old , with premature ejaculation but without any obvious organic cause were enrolled . Pretreatment evaluation included history , physical examination , and self-administration of the International Index of Erectile Function question naire . The patients were r and omly divided into two groups : group A patients ( n = 48 ) received 20 mg fluoxetine daily for 4 weeks and then 20 mg as needed 2–3 h before sexual activity for 4 months , and group B patients ( n = 43 ) received group A regimen plus 50 mg sildenafil as needed 1 h before sexual activity for 4 months . Results : Ejaculatory latency time and intercourse satisfaction significantly improved in group B as compared with group A ( p Fluoxetine combined with sildenafil seems to provide significantly better ejaculatory latency time and intercourse satisfaction as compared with fluoxetine alone in patients with premature ejaculation",
"BACKGROUND Recently , sildenafil has been demonstrated to be effective in treating premature ejaculation ( PE ) . However , these studies ignored female factors and could not exclude the probability of drug interaction when combined with paroxetine . Therefore , the aim of this study was to evaluate the efficacy and safety of sildenafil alone in the treatment of primary PE , taking female factors into consideration . METHODS One hundred and eighty potent men with primary PE were r and omly divided into three groups and followed up for 6 months . Group A were treated with 50 mg sildenafil as needed , group B with 20 mg paroxetine daily and group C with squeeze technique daily . Intravaginal ejaculatory latency time ( IELT ) , PE grade , intercourse satisfactory score ( ISS ) , frequency of intercourse , and adverse effects of drugs were recorded before treatment , and 3 and 6 months after treatment . RESULTS Compared with pretreatment , the three groups had significant differences in all the parameters after 3 or 6 months treatment , except the frequency of intercourse in Group C ( all P = 0.00 ) . However , there were no significant differences between 3 and 6 months . Compared with paroxetine and squeeze technique , after 3 or 6 months , sildenafil had significant differences in all the parameters ( all P = 0.00 ) . After 6 months , 1.7 % , 18.3 % and 36.7 % patients in groups A , B and C , respectively , withdrew from the study and 86.7 % , 60.0 % and 45.0 % patients , respectively , wanted to be treated further with the original administration , and this was statistically significant ( both P = 0.00 ) . CONCLUSION Sildenafil is very effective and safe to treat PE , and has much higher efficacy than paroxetine and squeeze technique",
"OBJECTIVE To compare the efficacy and safety of sildenafil plus sertraline with those of sertraline alone in the treatment of premature ejaculation ( PE ) . METHODS Seventy-two patients with PE but without any obvious organic cause were enrolled in this study . They were r and omly divided into Groups A and B of equal number . Group A received 50 mg sertraline daily 4 to 6 hours before planned sexual activity for 12 weeks , and Group B were given 50 mg sertraline daily plus 50 mg sildenafil as needed , 1 hour before planned sexual activity , for 12 weeks . Before and after the treatment , the mean intravaginal ejaculation latency time , the intercourse satisfaction , the mean number of coituses per week and the drug-related side effects were evaluated . RESULTS The mean intravaginal ejaculatory latency time was ( 0.59 + /- 0.12 ) , ( 3.9 + /- 0.15 ) minutes ( P mean intercourse satisfaction domain values of the IIEF were ( 8.9 + /- 1.2 ) , ( 10.8 + /- 1.1 ) ( P mean numbers of coituses per week in Groups A and B were ( 0.9 + /- 0.2 ) , ( 1.9 + /- 0.3 ) ( P headaches ( P flushing episodes ( P Sertraline combined with sildenafil can produce significantly better results than sertraline alone in patients with premature ejaculation . However , the combined treatment is associated with a slight increase in the drug-related side effects",
"INTRODUCTION Intravaginal ejaculation latency time ( IELT ) , defined as the time between the start of vaginal intromission and the start of intravaginal ejaculation , is increasingly used in clinical trials to assess the amount of selective serotonin reuptake inhibitor-induced ejaculation delay in men with premature ejaculation . Prospect ively , stopwatch assessment of IELTs has superior accuracy compared with retrospective question naire and spontaneous reported latency . However , the IELT distribution in the general male population has not been previously assessed . AIM To determine the stopwatch assessed-IELT distribution in large r and om male cohorts of different countries . METHODS A total of 500 couples were recruited from five countries : the Netherl and s , United Kingdom , Spain , Turkey , and the United States . Enrolled men were aged 18 years or older , had a stable heterosexual relationship for at least 6 months , with regular sexual intercourse . The surveyed population were not included or excluded by their ejaculatory status and comorbidities . This survey was performed on a \" normal \" general population . Sexual events and stopwatch-timed IELTs during a 4-week period were recorded , as well as circumcision status and condom use . MAIN OUTCOME MEASURES The IELT , circumcision status , and condom use . RESULTS The distribution of the IELT in all the five countries was positively skewed , with a median IELT of 5.4 minutes ( range , 0.55 - 44.1 minutes ) . The median IELT decreased significantly with age , from 6.5 minutes in the 18 - 30 years group , to 4.3 minutes in the group older than 51 years ( P median IELT varied between countries , with the median value for Turkey being the lowest , i.e. , 3.7 minutes ( 0.9 - 30.4 minutes ) , which was significantly different from each of the other countries . Comparison of circumcised ( N=98 ) and not-circumcised ( N=261 ) men in countries excluding Turkey result ed in median IELT values of 6.7 minutes ( 0.7 - 44.1 minutes ) in circumcised compared with 6.0 minutes ( 0.5 - 37.4 minutes ) in not-circumcised men ( not significant ) . The median IELT value was not affected by condom use . CONCLUSION The IELT distribution is positively skewed . The overall median value was 5.4 minutes but with differences between countries . For all five countries , median IELT values were independent of condom usage . In countries excluding Turkey , the median IELT values were independent of circumcision status"
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OBJECTIVE Advanced practice physiotherapists ( APPs ) , also known as extended scope physiotherapists , provide a new model of service delivery for musculoskeletal ( MSK ) disorders . Research to date has largely focused on health service efficiencies , with less emphasis on patient outcomes . The present systematic review aim ed to identify the patient-reported outcome measures ( PROMs ) being utilized by APPs . METHOD A wide search strategy was employed , including the PubMed , Embase , CINAHL , CENTRAL and PEDro data bases , to identify studies relating to PROMs utilized by APPs in MSK healthcare setting s. PROMs identified were classified into predetermined outcome domains , with additional context ual data extracted . RESULTS Of the initial 12,302 studies , 38 met the inclusion criteria . These involved APPs across different setting s , utilizing 72 different PROMs and most commonly capturing : Patient Satisfaction , Quality of Life ( QoL ) , Functional Status , and Pain ; and , less frequently : Global Status ( i.e. overall improvement ) , Psychological Well-Being , Work ability , and Healthcare Consumption and Costs . The quality of the PROMs varied greatly , with Satisfaction most commonly measured utilizing non-st and ardized locally-devised tools ; the EuroQol five-dimensions question naire ( EuroQoL-5D ) and 36-Item Short-Form ( SF-36 ) cited most frequently to capture QoL ; and the Visual Analogue Scale ( VAS ) to capture Pain . No key measure was identified to capture Functional Status , with 15 different tools utilized . CONCLUSION APPs utilized a multiplicity of PROMs across a range of MSK disorders . The present review will act as an important re source , informing the selection of outcomes for MSK disorders , with a view to greater st and ardization of outcome measurement in MSK clinical practice , service evaluation and research
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"Different methods of obtaining information in medical and social research present problems of interpretation for the research er . However , there are few systematic studies on the extent of the lack of concordance yielded by different methods . This paper uses data from a r and omized controlled trial of social support in pregnancy to examine this issue in relation to three methods of data collection --medical records , home interviews and a postal question naire -- on the following topics : obstetric history ; smoking , alcohol use , number of antenatal hospital visits , bleeding and depression in pregnancy ; length of labour ; baby 's sex , birthweight and neonatal health problems ; and ethnicity . Considerable discrepancies are found comparing the different data sources . These suggest that mothers may be more reliable sources of information than medical records , and that the anonymity of a postal question naire may provide higher estimates than home interviews on some sensitive topics , such as smoking in pregnancy",
"Background The Knee injury and Osteoarthritis Outcome Score ( KOOS ) is an extension of the Western Ontario and McMaster Universities Osteoarthrtis Index ( WOMAC ) , the most commonly used outcome instrument for assessment of patient-relevant treatment effects in osteoarthritis . KOOS was developed for younger and /or more active patients with knee injury and knee osteoarthritis and has in previous studies on these groups been the more responsive instrument compared to the WOMAC . Some patients eligible for total knee replacement have expectations of more dem and ing physical functions than required for daily living . This encouraged us to study the use of the Knee injury and Osteoarthritis Outcome Score ( KOOS ) to assess the outcome of total knee replacement . Methods We studied the test-retest reliability , validity and responsiveness of the Swedish version LK 1.0 of the KOOS when used to prospect ively evaluate the outcome of 105 patients ( mean age 71.3 , 66 women ) after total knee replacement . The follow-up rates at 6 and 12 months were 92 % and 86 % , respectively . Results The intraclass correlation coefficients were over 0.75 for all subscales indicating sufficient test-retest reliability . Bl and -Altman plots confirmed this finding . Over 90 % of the patients regarded improvement in the subscales Pain , Symptoms , Activities of Daily Living , and knee-related Quality of Life to be extremely or very important when deciding to have their knee operated on indicating good content validity . The correlations found in comparison to the SF-36 indicated the KOOS measured expected constructs . The most responsive subscale was knee-related Quality of Life . The effect sizes of the five KOOS subscales at 12 months ranged from 1.08 to 3.54 and for the WOMAC from 1.65 to 2.56 . Conclusion The Knee injury and Osteoarthritis Outcome Score ( KOOS ) is a valid , reliable , and responsive outcome measure in total joint replacement . In comparison to the WOMAC , the KOOS improved validity and may be at least as responsive as the WOMAC",
"Background Specially trained physiotherapists ( advanced practice physiotherapists ( APP ) ) are working in orthopaedic clinics to improve access to orthopaedic services and support chronic disease management . Little attention has been paid to the impact APPs may have on non-surgical patients . In non-surgical patients with hip or knee arthritis consulting an APP in an orthopaedic clinic , the objectives were to : 1 ) describe patients ’ recall of APP recommendations , use of self-management strategies , and barriers to management six weeks following consultation ; and , 2 ) compare exercise behaviour and self-efficacy at baseline and six weeks . Findings This was a single group pre- and post-intervention study of patients who saw an APP when consulting the orthopaedic departments of two hospitals . At baseline and six weeks participants completed the adapted Stanford Exercise Behaviour Scale ( response options : none , 3 hours/week ) , and the Chronic Disease Self-efficacy Scale ( range 1–10 ; higher scores indicate higher self-efficacy ) . At follow-up participants completed questions on recall of APP recommendations , use of self-management strategies and barriers to management . Seventy three non-surgical patients with hip or knee arthritis participated , a response rate of 89 % at follow-up . Seventy one percent of patients reported that the APP recommended exercise , of whom 83 % reported exercising to manage their arthritis since the visit . Almost 50 % reported an increase in time spent stretching ; over 40 % reported an increase in time spent walking or doing strengthening exercises at follow-up . Common barriers to arthritis management were time , cost and other health problems . Mean chronic disease self-efficacy scores significantly improved from 6.3 to 7.2 ( p APP intervention for non-surgical patients referred for orthopaedic consultation showed promising results , particularly for enhancing use of conservative management strategies such as exercise",
"PURPOSE To investigate the effectiveness of a physiotherapy triage service for orthopaedic surgery referrals from primary -care physicians . METHODS A prospect i ve , observational design was used with patients referred to an orthopaedic surgeon based out of two small urban centres in British Columbia . The level of agreement between the physiotherapist and surgeon was determined using a weighted kappa statistic ( κw ) with 95 % CI . A patient satisfaction question naire was administered , and the surgical conversion rate ( SCR ) was calculated to assess the level of appropriate referrals . RESULTS The analysis found substantial agreement ( κw=0.77 ; 95 % CI , 0.60 - 0.94 ) between surgeon and physiotherapist for surgical management decisions . All patients reported being \" satisfied \" or \" very satisfied \" with the overall care they received from the physiotherapist . The SCR of patients referred by the physiotherapist to the surgeon was 91 % , versus 22 % among patients referred by a general practitioner or emergency physician . CONCLUSION More than three-fourths of patients referred by primary -care physicians did not need to see a surgeon and were able to be managed by an experienced orthopaedic physiotherapist . This triage model could have considerable impact on orthopaedic wait times in Canada by minimizing unnecessary referrals ; the model could also promote timely and conservative management of non-surgical conditions by physiotherapists",
"Background Role substitution is a strategy employed to assist health services manage the growing dem and for musculoskeletal care . Corticosteroid injection is a common treatment in this population but the efficacy of its prescription and delivery by physiotherapists has not been established against orthopaedic st and ards . This paper investigates whether corticosteroid injection given by a physiotherapist for shoulder pain is as clinical ly and cost effective as that from an orthopaedic surgeon . Methods A double blind non-inferiority r and omized controlled trial was conducted in an Australian public hospital orthopaedic outpatient service , from January 2013 to June 2014 . Adults with a General Practitioner referral to Orthopaedics for shoulder pain received subacromial corticosteroid and local anaesthetic injection prescribed and delivered independently by a physiotherapist or a consultant orthopaedic surgeon . The main outcome measure was total Shoulder Pain and Disability Index ( SPADI ) score at baseline , six and 12 weeks , applying a non-inferiority margin of 15 points . Secondary outcomes tested for superiority included pain , shoulder movement , perceived improvement , adverse events , satisfaction , quality of life and costs . Results 278 participants were independently assessed by the physiotherapist and the orthopaedic surgeon , with 64 r and omised ( physiotherapist 33 , orthopaedic surgeon 31 ) . There were no significant differences in baseline characteristics between groups . Non-inferiority of injection by the physiotherapist was declared from total SPADI scores at 6 and 12 weeks ( upper limit of the 95 % one-sided confidence interval 13.34 and 7.17 at 6 and 12 weeks , respectively ) . There were no statistically significant differences between groups on any outcome measures at 6 or 12 weeks . From the perspective of the health funder , the physiotherapist was less expensive . Conclusions Corticosteroid injection for shoulder pain , provided by a suitably qualified physiotherapist is at least as clinical ly effective , and less expensive , compared with similar care delivered by an orthopaedic surgeon . Policy makers and service providers should consider implementing this model of care . Trial Registration Australia and New Zeal and Clinical Trials Registry",
"BACKGROUND CONTEXT Clinimetric properties of the EuroQol-5D ( EQ-5D ) in patients with nonspecific chronic low back pain ( CLBP ) are largely unknown . PURPOSE To study the criterion validity , responsiveness , and minimal clinical ly important change ( MCIC ) of EQ-5D in patients with CLBP . STUDY DESIGN Prospect i ve study design carried out in a multispecialist Spine Center in The Netherl and s. PATIENT SAMPLE One hundred fifty-one patients with CLBP . OUTCOME MEASURES Quality of life ( QOL ) was measured with EQ-5D , consisting of two scales : one scale measuring QOL with five categorical questions and the other measuring health state on a visual analog scale ( 0 - 100 ) . Criterion measures were disability , measured with the Pain Disability Index ( PDI ) and the Rol and Morris Disability Question naire ( RMDQ ) , and pain intensity , measured with a numeric rating scale ( NRS ) . METHODS Pearson correlation coefficients between the EQ-5D and RMDQ , PDI , and NRS were calculated to test the criterion validity . Correlations were interpreted based on predefined criteria . Responsiveness of the EQ-5D was calculated with area under the receiver operating characteristics ( ROC ) curve . Minimal clinical ly important change was calculated with the optimal cutoff point under the ROC curve , and sensitivity and specificity were also calculated . RESULTS Correlations between EQ-5D and criterion measures ranged between 0.39 and 0.59 and were considered moderate to good . Areas under the ROC curve ranged from 0.59 to 0.72 depending on the external criterion and EQ-5D subscale . The MCIC was 0.03 points for the categorical scales of the EQ-5D and 10.5 points for the EQ-5D visual analog scale . CONCLUSIONS The EQ-5D is a valid and responsive QOL scale in patients with CLBP ",
"Abstract . When measuring treatment effect in chronic low back pain with multi-item outcome instruments , it is necessary , both for clinical decision-making and research purpose s , to underst and the clinical importance of the outcome scores . The aims of the present study were three-fold . Firstly , it aim ed to estimate the minimal clinical ly important difference of three multi-item outcome instruments ( the Oswestry Disability Index , the General Function Score and the Zung Depression Scale ) and of the visual analogue scale ( VAS ) of back pain . Secondly , it aim ed to estimate the error of measurement of these instruments ; and its third aim was to describe the clinical meaning of score change . The study population consisted of 289 patients treated surgically or non-surgically in a r and omised controlled trial . The minimal clinical ly important difference was estimated with patient global assessment as the external criterion . It was compared with the st and ard error of measurement of the instruments . The individual items of the instruments were compared for score changes related to improvement and deterioration . The st and ard error of measurement of the Oswestry Disability Index , the General Function Score and the Zung Depression Scale was 4 , 6 and 3 units , respectively . The 95 % tolerance interval was 10 , 16 and 8 units , respectively . The minimal clinical ly important difference was 10 , 12 and 8–9 units , respectively , thus not significantly exceeding the tolerance interval . The minimal clinical ly important difference of VAS back pain was 18–19 units , well exceeding the 95 % tolerance interval , which was 15 units . Improvement after treatment for chronic low back pain tends to occur to a greater extent in sleep disturbance , ability to do usual things and psychological irritability , but to a lesser extent in the ability to sit , st and and lift . We conclude that the VAS of back pain is responsive enough to detect the minimal clinical ly important difference , whereas the smallest acceptable score changes of the Oswestry Disability Index , the General Function Score and the Zung Depression Scale may require an increase to exceed the 95 % tolerance interval when used for clinical decision making and for power calculation . Despite improvement after treatment , the ability to sit , st and and lift , remain notable problems",
"OBJECTIVE : To evaluate the effectiveness and cost effectiveness of specially trained physiotherapists in the assessment and management of defined referrals to hospital orthopaedic departments . DESIGN : R and omised controlled trial . SETTING : Orthopaedic outpatient departments in two hospitals . SUBJECTS : 481 patients with musculoskeletal problems referred for specialist orthopaedic opinion . INTERVENTIONS : Initial assessment and management undertaken by post-Fellowship junior orthopaedic surgeons , or by specially trained physiotherapists working in an extended role ( orthopaedic physiotherapy specialists ) . MAIN OUTCOME MEASURES : Patient centred measures of pain , functional disability and perceived h and icap . RESULTS : A total of 654 patients were eligible to join the trial , 481 ( 73.6 % ) gave their consent to be r and omised . The two arms ( doctor n = 244 , physiotherapist n = 237 ) were similar at baseline . Baseline and follow up question naires were completed by 383 patients ( 79.6 % ) . The mean time to follow up was 5.6 months after r and omisation , with similar distributions of intervals to follow up in both arms . The only outcome for which there was a statistically or clinical ly important difference between arms was in a measure of patient satisfaction , which favoured the physiotherapist arm . A cost minimisation analysis showed no significant differences in direct costs to the patient or NHS primary care costs . Direct hospital costs were lower ( p < 0.00001 ) in the physiotherapist arm ( mean cost per patient = 256 Pounds , n = 232 ) , as they were less likely to order radiographs and to refer patients for orthopaedic surgery than were the junior doctors ( mean cost per patient in arm = 498 Pounds , n = 238 ) . CONCLUSIONS : On the basis of the patient centred outcomes measured in this r and omised trial , orthopaedic physiotherapy specialists are as effective as post-Fellowship junior staff and clinical assistant orthopaedic surgeons in the initial assessment and management of new referrals to outpatient orthopaedic departments , and generate lower initial direct hospital costs",
"BACKGROUND CONTEXT A variety of self-report and physical performance-based outcome measures are commonly used to assess progress and recovery in the lower leg , ankle , and foot . A requisite attribute of any outcome measure is its ability to detect change in a condition , a construct known as \" responsiveness \" . There is a lack of consistency in how responsiveness is defined in all outcome measures . PURPOSE The purpose of this study was to review the currently used recovery outcome measures for lower leg , ankle and foot conditions in order to determine and report recommended responsiveness values . METHODS A systematic literature search that included electronic search es of PubMed , CINAHL and SportD iscus as well extensive cross-referencing was performed in January , 2013 . Studies were included if each involved : 1 ) a prospect i ve , longitudinal study of any design ; 2 ) any condition associated with the lower leg , ankle or foot ; 3 ) a measure of responsiveness ; and 4 ) was an acceptable type of outcome measure ( eg . self-report , physical performance , or clinician report ) . The quality of the included articles was assessed by two independent authors using the responsiveness sub-component of the Consensus-based St and ards for the selection of health Measurement Instruments ( COSMIN ) . RESULTS Sixteen different studies met the inclusion criteria for this systematic review . The most commonly used outcome measures were the Foot and Ankle Ability Measure and the Lower Extremity Functional Scale . Responsiveness was calculated in a variety of methods including effect size , st and ardized response mean , minimal clinical ly important difference/ importance , minimal detectable change , and minimal important change . CONCLUSION Based on the findings of this systematic review there is a lack of consistency for reporting responsiveness among recovery measures used in the lower leg , ankle or foot studies . It is possible that the variability of conditions that involve the lower leg , ankle and foot contribute to the discrepancies found in reporting responsiveness values . Further research must be conducted in order to st and ardize reporting measures for responsiveness . LEVEL OF EVIDENCE 2a",
"A large proportion of patients who consult primary healthcare for musculoskeletal pain are referred for orthopaedic consultation , but only a small number of these patients are appropriate for orthopaedic intervention . Experienced physiotherapists have the appropriate knowledge to manage musculoskeletal disorders . The primary aim of this r and omised study was therefore to evaluate a screening by a physiotherapist of patients referred for orthopaedic consultation compared to st and ard practice in primary care . Patients referred for orthopaedic consultation ( n=203 ) were r and omised to physiotherapy screening or st and ard practice . Selection accuracy for orthopaedic intervention and other referrals were analysed with proportion analysis . Patient views of the quality of care were analysed with Mann-Whitney U-test , waiting time with Independent t-test . There was higher selection accuracy for orthopaedic intervention in the physiotherapy screening group ( p=0.002 ) . A smaller proportion of patients in the screening group were referred back to their general practitioner ( GP ) ( p physiotherapy clinic ( p proportion of patients referred for further investigations was significantly lower in the physiotherapy screening group ( p Waiting time was shorter in the screening group ( p attend the clinic for future care , no difference between the groups ( p<0.95 ) . The findings in this study suggest that an experienced physiotherapist effectively can screen patients referred for orthopaedic consultation in primary healthcare",
"INTRODUCTION The literature indicates that physiotherapy triage assessment can be efficient for patients referred for orthopaedic consultation , however long-term follow up of patient reported outcome measures are not available . AIM To report a long-term evaluation of patient-reported health-related quality of life , pain-related disability , and sick leave after a physiotherapy triage assessment of patients referred for orthopaedic consultation compared with st and ard practice . METHODS Patients referred for orthopaedic consultation ( n = 208 ) were r and omised to physiotherapy triage assessment or st and ard practice . The r and omised cohort was analysed on an intention-to-treat ( ITT ) basis . The patient reported outcome measures EuroQol VAS ( self-reported health-state ) , EuroQol 5D-3L ( EQ-5D ) and Pain Disability Index ( PDI ) were assessed at baseline and after 3 , 6 and 12 months . EQ VAS was analysed using a repeated measure ANOVA . PDI and EQ-5D were analysed using a marginal logistic regression model . Sick leave was analysed for the 12 months following consultation using a Mann-Whitney U-test . RESULTS The patients rated a significantly better health-state at 3 after physiotherapy triage assessment [ mean difference -5.7 ( 95 % CI -11.1 ; -0.2 ) ; p = 0.04 ] . There were no other statistically significant differences in perceived health-related quality of life or pain related disability between the groups at any of the follow-ups , or sick leave . CONCLUSION This study reports that the long-term follow up of the patient related outcome measures health-related quality of life , pain-related disability and sick leave after physiotherapy triage assessment did not differ from st and ard practice , indicating the possible benefits of implementation of this model of care",
"OBJECTIVES To evaluate primary physiotherapist assessment and management of patients with musculoskeletal disorders in primary care , and to compare patient satisfaction with primary assessment by a physiotherapist or a general practitioner ( GP ) . DESIGN An observational , retrospective cohort study review ing medical records , and a separate consecutive non-r and omised study of patient satisfaction . SETTING Primary healthcare centre . PARTICIPANTS Four hundred and thirty-two patients with musculoskeletal disorders , primarily assessed by a physiotherapist . Fifty-one of these patients primarily assessed by a physiotherapist and 42 patients assessed by a GP answered a patient satisfaction question naire . INTERVENTIONS Primary assessment and management of patients with musculoskeletal disorders . MAIN OUTCOME MEASURES Data from medical records within 3-month after the visit , and patient satisfaction question naire . RESULTS Eighty-five percent ( 367/432 ) of patients did not need to see a GP . Serious pathologies were found among the 6 % ( 26/432 ) of patients who were referred to a GP by a physiotherapist , but no serious pathologies were found among the 9 % ( 39/432 ) of patients who subsequently returned for a GP appointment for the same disorder . Patients assessed by a physiotherapist were more satisfied with the information received about their disorder and self-care than patients assessed by a GP . Patients also had higher confidence in the ability of physiotherapists to assess their disorder ( P patients with musculoskeletal disorders in primary care as few patients needed additional assessment by a GP , patients with confirmed serious pathologies were identified by the physiotherapists , and patients were satisfied with assessment by a physiotherapist",
"Objective : The Department of Health is review ing the effectiveness of accident and emergency ( A&E ) departments . This study aim ed to compare health and economic effects of physiotherapy initial assessment and management with routine practice in an A&E department . Methods : R and omised controlled trial and cost and consequences study . Patients presenting at A&E were eligible if suspected at triage to have soft tissue injury without fracture . The efficacy end point was “ days to return to usual activities ” . Secondary end points included patient satisfaction with their care and further health outcomes and cost data . Results : 766 of 844 ( 915 ) patients were r and omised . The median days before return to usual activities ( available for 73 % of those r and omised ) was greater in the physiotherapist group ( 41 days compared with 28.5 days ; hazard ratio 0.85 p = 0.071 ) . The physiotherapy group expressed greater satisfaction with their A&E care ( on a scale of 1 to 5 , median was 4.2 compared with 4.0 , p Costs were the same between the two arms . Conclusion : There is evidence that physiotherapy leads to a prolonged time before patients return to usual activities . This study shows no clear danger from physiotherapy intervention and long term outcomes may be different but given these findings , a best estimate is that introducing physiotherapist assessment will increase costs to the health service and society . Routine care should continue be provided unless there is some reason why it is not feasible to do so and an alternative must be found",
"OBJECTIVES To describe the clinical course of knee osteoarthritis following a single course of intra-articular hyaluronic acid ( HA ) injection clinic , and specifically to explore treatment withdrawal . DESIGN Prospect i ve consecutive case series with follow-up , set in an innovative physiotherapist-led clinic , based in a hospital orthopaedic surgery department . PARTICIPANTS A total of 100 patients with knee osteoarthritis referred to the clinic received a single course of five injections of Hyalgan . Patients were followed up in clinic at five , 13 , 26 and 52 weeks . The primary outcome measures were Western Ontario McMaster Universities Osteoarthritis Index ( WOMAC ) Likert 3.0 pain ( 0 - 20 ) and physical function ( 0 - 68 ) scores . In addition , at 13 and 26 weeks , patients were review ed independently by an orthopaedic surgeon , with the option of withdrawing for alternative management those patients who had not responded . RESULTS Ninety ( 90 % ) patients were successfully followed to study endpoint . Improvements were seen at five weeks and , to a lesser extent , at 13 weeks ( mean reduction in WOMAC pain at 13 weeks = 1.3 ; 95 % confidence interval [ CI ] 0.5 , 2.0 ; mean reduction in WOMAC Physical Function at 13 weeks = 5.6 ; 95 % CI 3.0 , 8.1 ) . Of 34 treatment withdrawals , most had returned to baseline levels by 13 weeks . The remaining 56 patients maintained improvements up to 52 weeks , although the pattern of outcome was highly variable between individuals . Withdrawals and non-responders had higher initial pain severity . CONCLUSIONS Physiotherapist-led intra-articular HA clinics are feasible . Clinical outcomes for individual patients are highly heterogeneous up to one year after injections . Patients with initially high levels of pain may be less likely to benefit",
"BACKGROUND AND PURPOSE The purpose of this study was to assess the reliability , construct validity , and sensitivity to change of the Lower Extremity Functional Scale ( LEFS ) . SUBJECTS AND METHODS The LEFS was administered to 107 patients with lower-extremity musculoskeletal dysfunction referred to 12 outpatient physical therapy clinics . METHODS The LEFS was administered during the initial assessment , 24 to 48 hours following the initial assessment , and then at weekly intervals for 4 weeks . The SF-36 ( acute version ) was administered during the initial assessment and at weekly intervals . A type 2,1 intraclass correlation coefficient was used to estimate test-retest reliability . Pearson correlations and one-way analyses of variance were used to examine construct validity . Spearman rank-order correlation coefficients were used to examine the relationship between an independent prognostic rating of change for each patient and change in the LEFS and SF-36 scores . RESULTS Test-retest reliability of the LEFS scores was excellent ( R = .94 [ 95 % lower limit confidence interval ( CI ) = .89 ] ) . Correlations between the LEFS and the SF-36 physical function subscale and physical component score were r=.80 ( 95 % lower limit CI = .73 ) and r = .64 ( 95 % lower limit CI = .54 ) , respectively . There was a higher correlation between the prognostic rating of change and the LEFS than between the prognostic rating of change and the SF-36 physical function score . The potential error associated with a score on the LEFS at a given point in time is + /-5.3 scale points ( 90 % CI ) , the minimal detectable change is 9 scale points ( 90 % CI ) , and the minimal clinical ly important difference is 9 scale points ( 90 % CI ) . CONCLUSION AND DISCUSSION The LEFS is reliable , and construct validity was supported by comparison with the SF-36 . The sensitivity to change of the LEFS was superior to that of the SF-36 in this population . The LEFS is efficient to administer and score and is applicable for research purpose s and clinical decision making for individual patients",
"Abstract This study examined the relations between disability , as measured by the Pain Disability Index ( PDI ) and self‐efficacy , fear avoidance variables ( kinesiophobia and catastrophizing ) , and pain intensity , using a prospect i ve design . Two primary health care sample s ( n1=210 ; n2=161 ) of patients with subacute , chronic or recurring musculoskeletal pain completed sets of question naires at the beginning of a physiotherapy treatment period . Multiple hierarchial regression analyses showed that self‐efficacy explained a considerably larger proportion of the variance in disability scores than the fear avoidance variables in the first sample . This finding was replicated in the second sample . Pain intensity explained a small , but significant proportion of the variance in disability scores in one sample only . Gender , age , and pain duration were not related to disability . These findings suggest that self‐efficacy beliefs are more important determinants of disability than fear avoidance beliefs in primary health care patients with musculoskeletal pain . The findings also suggest that pain‐related beliefs , such as self‐efficacy and fear avoidance , in turn , are more important determinants of disability than pain intensity and pain duration in these patients",
"This paper describes constructing the Assessment of Quality of Life ( AQoL ) instrument ; design ed to measure health-related quality of life ( HRQoL ) , and to be the descriptive system for a multi-attribute utility instrument . Unlike previous utility instruments ' descriptive systems , the AQoL 's has been developed using state-of-the-art psychometric procedures . The result is a descriptive system which emphasizes five different facets of HRQoL and which can cl aim to have construct validity . Based on the WHO 's definition of health a model of HRQoL was developed . Items were written by focus groups of doctors and the research ers . These were administered to a construction sample , comprising hospital patients , and community members chosen at r and om . Final construction was through an iterative process of factor and reliability analyses . The AQoL measures 5 dimensions : illness , independent living , social relationships , physical senses and psychological wellbeing . Each has three items . Exploratory factor analysis showed the dimensions were orthogonal , and each was unidimensional . Internal consistency was α = 0.81 . Structural equation modeling explored its internal structure ; the comparative fit index was 0.90 . These preliminary results indicate the AQoL has the prerequisite qualities for a psychometric HRQoL instrument for evaluation ; replication with a larger sample is needed to verify these findings . Scaling it for economic evaluation using utilities is being undertaken . Respondents have indicated the AQoL is easy to underst and and is quickly completed . Its initial properties suggest it may be widely applicable",
"OBJECTIVE To investigate the impact , quality and acceptability of a musculoskeletal screening clinic provided by physiotherapists for patients referred to the outpatient orthopaedic department at a major metropolitan hospital . DESIGN , SETTING AND PARTICIPANTS Prospect i ve observational trial undertaken between 29 November 2005 and 6 June 2006 at the Northern Hospital ( a tertiary teaching hospital in outer Melbourne ) of 52 patients with non-urgent musculoskeletal conditions who were assessed by one of two physiotherapists with postgraduate qualifications and subsequently by an orthopaedic surgeon . MAIN OUTCOME MEASURES Proportion of new patients referred who could have been managed without needing to see a surgeon ; level of agreement between physiotherapists and orthopaedic surgeon on diagnoses and management decisions ; and levels of satisfaction of patients , referring general practitioners and the orthopaedic surgeon with the physiotherapist-led screening initiative . RESULTS 45 of 52 selected patients ( 31 women and 21 men ; mean age , 53.3 years ) attended their appointment with the physiotherapist ; of these , 38 also attended a later appointment with the orthopaedic surgeon . Seven of the 38 patients were listed for surgery , and seven others needed management by the surgeon ( injection for three , imaging for four ) . Almost two-thirds ( 63 % ) were appropriate for non-surgical management . The physiotherapists identified the same patient management plans as the surgeon for 74 % of the group . Patients and doctors reported high levels of satisfaction with the physiotherapist-led service . CONCLUSIONS Nearly two-thirds of patients with non-urgent musculoskeletal conditions referred by their GPs to one public outpatient orthopaedic department did not need to see a surgeon at the time of referral , and were appropriately assessed and managed by experienced , qualified physiotherapists",
"Abstract Objectives : ( 1 ) To attain a quantitative estimate of patient satisfaction with physiotherapy care for musculoskeletal conditions in Australia ; ( 2 ) to compare the observed level of patient satisfaction with care in Australia with those from other countries ; and ( 3 ) to compare factors contributing to patient satisfaction between Australia and the United States ( US ) . Methods : We conducted a prospect i ve study of 274 patients presenting for physiotherapy treatment of a musculoskeletal disorder in Australian clinics . Patient satisfaction was measured using the 20-item MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care ( MRPS ) and satisfaction scores were compared with those from Northern Europe , North America , the United Kingdom , and Irel and . To investigate factors contributing to patient satisfaction between Australia and the US , we compared 20-item MRPS data from Australian and Spanish-speaking US cohorts . Results : Mean Australian MRPS satisfaction score was 4·55 ( 95 % confidence interval : 4·51–4·59 ) on a scale of 1 to 5 , where 1 indicates high dissatisfaction and 5 indicates high satisfaction . This high level of patient satisfaction is consistent with international data . Australian respondents specifically valued interpersonal aspects of care , including advice and information about their condition and an explanation about self-management . The correlation between treatment outcomes and global patient satisfaction was low ( r = −0·22 ) . A comparison of data collected from Australia and the US showed that MRPS items regarding interpersonal aspects of care , such as the therapists ’ communication skills , correlated strongly with global satisfaction in both countries . However , there were other question naire items for which the correlation with global satisfaction was significantly different between Australia and the US . Conclusions : Patient satisfaction with musculoskeletal physiotherapy care in Australia is high and comparable with Northern Europe , North America , the United Kingdom and Irel and . Comparison of data between Australia and the US indicates that while some determinants of patient satisfaction are common , country-specific differences also exist",
"OBJECTIVES To evaluate the clinical effectiveness of a primary care musculoskeletal clinical assessment service ( MCAS ) . The MCAS is a triage and treatment service for the management of patients with musculoskeletal conditions . DESIGN Prospect i ve observational cohort study . PARTICIPANTS Consecutive patients with musculoskeletal disorders referred to the MCAS from primary care over a 6-month period . INTERVENTIONS Patients were managed within the service in accordance with usual MCAS management/treatment pathways . MAIN OUTCOME MEASURES Previously vali date d self-administered question naires were selected as outcome measures in order to facilitate the use of postal responses . These comprised two generic health status question naires ( Short Form 36 , EuroQol EQ-5D ) , a pain assessment using a visual analogue scale and two measures of patient satisfaction ( Perceived Improvement Evaluation , Deyo and Diehl satisfaction question naire ) . Outcome measures were taken at baseline , and 3 and 12 months after recruitment . RESULTS In total , 217 patients were recruited into the study . Significant improvement was demonstrated with EuroQol at 3 and 12 months ( P=0.043 and 0.035 , respectively ) and the pain visual analogue scale at 3 and 12 months ( P=0.001 and 0.002 , respectively ) . No significant differences were demonstrated with Short Form 36 ( P=0.73 and 0.87 ) . The mean patient-perceived improvement was 33 % at 3 months and 46 % at 12 months . Results showed high levels of patient satisfaction , with 72 % of patients indicating total satisfaction with all aspects of the MCAS . CONCLUSIONS Nationally , models similar to the MCAS have been developed to help improve care for patients and achieve the 18-week access target . This preliminary study shows the possible benefits of adopting this model of care , and identifies the need for further research",
"PURPOSE To examine the role of an advanced- practice physiotherapist ( APP ) with respect to ( 1 ) agreement with an orthopaedic surgeon on diagnosis and management of patients with shoulder problems ; ( 2 ) wait times ; and ( 3 ) satisfaction with care . METHODS This prospect i ve study involved patients with shoulder complaints who were referred to a shoulder specialist in a tertiary care centre . Agreement was examined on seven major diagnostic categories , need for further examination and surgery , and type of surgical procedure . Wait times were compared between the APP- and surgeon-led clinics from referral date to date of initial consultation , date of final diagnostic test , and date of confirmed diagnosis and planned treatment . A modified and vali date d version of the Visit-Specific Satisfaction Instrument assessed satisfaction in seven domains . Kappa ( κ ) coefficients and bias- and prevalence-adjusted kappa ( PABAK ) values were calculated , and strength of agreement was categorized . Wait time and satisfaction data were examined using non-parametric statistics . RESULTS Agreement on major diagnostic categories varied from 0.68 ( good ) to 0.96 ( excellent ) . Agreement with respect to indication for surgery was κ=0.75 , p good ) . Wait time for APP assessment was significantly shorter than wait time for surgeon consultation at all time points ( p ) ; the surgeon 's wait time was significantly reduced over 3 years . High satisfaction was reported in all components of care received from both health care providers . CONCLUSIONS Using experienced physiotherapists in an extended role reduces wait times without compromising patient clinical management and overall satisfaction",
"The assessment of a measure of chronic pain , should be reliable , valid and sensitive to change . Our study evaluated the reliability of 3 pain scales , visual analogue scale ( VAS ) , numerical rating scale ( NRS ) and verbal rating scale ( VRS ) in literate and illiterate patients with rheumatoid arthritis ( RA ) . Patients with RA attending an outpatient rheumatology clinic were interviewed and asked to score their pain levels on the 3 pain scales . The scales were presented in r and om order , twice , before and just after a regular medical consultation . Ninety-one patients were studied ( 25 illiterate and 66 literate ) . The Pearson product moment correlation between first and second assessment was 0.937 for VAS , 0.963 for NRS and 0.901 for VRS in the literate patient group and 0.712 for VAS , 0.947 for NRS and 0.820 for VRS in the illiterate patient group . These results indicate that the NRS has the higher reliability in both groups of patients",
"A shoulder pain and disability index ( SPADI ) was developed to measure the pain and disability associated with shoulder pathology . The SPADI is a self-administered index consisting of 13 items divided into two subscales : pain and disability . Thirty-seven male patients with shoulder pain were used in a study to examine the measurement characteristics of the SPADI . Test-retest reliability of the SPADI total and subscale scores ranged from 0.6377 to 0.6552 . Internal consistency ranged from 0.8604 to 0.9507 . SPADI total and subscale scores were highly negatively correlated with shoulder range of motion ( ROM ) supporting the criterion validity of the index . Principal components factor analysis with and without varimax rotation supported the construct validity of the total SPADI and its subscales . High negative correlations between changes in SPADI scores and changes in shoulder ROM indicated the SPADI detected changes in clinical status over short time intervals . The SPADI should prove useful for both clinical and research purpose",
"Objectives To evaluate the clinical effectiveness of soft tissue injury management by emergency nurse practitioners ( ENPs ) and extended scope physiotherapists ( ESPs ) compared to the routine care provided by doctors in a UK emergency department ( ED ) . Design R and omised , pragmatic trial of equivalence . Setting One adult ED in Engl and . Participants 372 patients were r and omised ; 126 to the ESP group , 123 to the ENP group and 123 to the doctor group . Participants were adults ( older than 16 years ) presenting to the ED with a peripheral soft tissue injury eligible for management by any of the three professional groups . Patients were excluded if they had any of the following : injury greater than 72 hours old ; systemic disease ; dislocated joints ; recent surgery ; unable to give informed consent ( eg , dementia ) , open wounds ; major deformities ; opiate analgesia required ; concurrent chest/rib injury ; neurovascular deficits and associated fracture . Interventions Patients were r and omised to treatment by ESPs , ENPs or routine care provided by doctors ( of all grade s ) . Main outcome measures Upper-limb and lower-limb functional scores , quality of life , physical well-being , preference-based health measures and the number of days off work . Results The clinical outcomes of soft tissue injury treated by ESPs and ENPs in the ED were equivalent to routine care provided by doctors . Conclusions As all groups were clinical ly equivalent it is other factors such as cost , workforce sustainability , service provision and skill mix that become important . This result vali date s the role of the ENP , which is becoming established as an integral part of minor injuries care , and demonstrates that the ESP should be considered as part of the clinical skill mix without detriment to outcomes . IS RCT N-IS RCT N trials register number 70891354"
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The aim of this systematic review was to investigate the task specificity of strength training programs for walking in neurologic rehabilitation . Nine electronic data bases were search ed from conception to October 2012 for r and omized controlled trials that used strength training to improve walking in adult neurologic population s. The search identified 25 r and omized controlled trials that investigated the efficacy of strength training to improve walking in people with a variety of neurologic conditions . The results revealed that despite significant strength gains , many studies failed to show a significant improvement in walking capacity . Most studies did not include exercises relating to all three main power events important for walking . Strength testing and strengthening exercises were prioritized for the knee extensors and flexors , despite their relatively minor role in human walking . Strengthening exercises performed in the neurologic population are not specific to the main muscle groups responsible for the power generation required for walking . There is a predisposition for strength testing and strengthening exercises to focus on the knee flexors and extensors despite their relatively minor role during walking . Further consideration of the specificity of strength training may provide greater translation of strength gains to improved walking outcomes
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"Background . Resistance training research has demonstrated positive effects for persons with Parkinson 's disease ( PD ) , but the number of acute training variables that can be manipulated makes it difficult to determine the optimal resistance training program . Objective . The purpose of this investigation was to examine the effects of an 8-week resistance training intervention on strength and function in persons with PD . Methods . Eighteen men and women were r and omized to training or st and ard care for the 8-week intervention . The training group performed 3 sets of 5–8 repetitions of the leg press , leg curl , and calf press twice weekly . Tests included leg press strength relative to body mass , timed up- and -go , six-minute walk , and Activities-specific Balance Confidence question naire . Results . There was a significant group-by-time effect for maximum leg press strength relative to body mass , with the training group significantly increasing their maximum relative strength ( P .05 ) . Conclusions . Moderate volume , high-load weight training is effective for increasing lower-body strength in persons with PD",
"OBJECTIVES To determine whether changes in strength or cardiorespiratory fitness after exercise training improve walking ability in individuals who have had a stroke . DESIGN A sham exercise-controlled , r and omized two-by-two factorial design , in which the two factors investigated were cycle training ( AEROBIC ) and resistance training ( STRENGTH ) . SETTING University exercise laboratory . PARTICIPANTS Fifty-two individuals with a history of stroke ( aged 63+/-9 ; time since stroke , 57+/-54 months ) . INTERVENTION Participants undertook 30 exercise sessions over 10 to 12 weeks . Depending on group allocation , individuals underwent aerobic cycling plus sham progressive resistance training ( PRT ) ( n=13 ) , sham cycling plus PRT ( n=13 ) , aerobic cycling plus PRT ( n=14 ) , or sham cycling plus sham PRT ( n=12 ) . MEASUREMENTS Primary outcomes were 6-minute walk distance , habitual and fast gait velocities , and stair climbing power . Secondary outcomes included measures of cardiorespiratory fitness ; muscle strength , power , and endurance ; and psychosocial attributes . RESULTS Neither AEROBIC nor STRENGTH improved walking distance or gait velocity significantly more than sham exercise , although STRENGTH significantly improved participants ' stair climbing power by 17 % ( P=.009 ) , as well as their muscle strength , power , and endurance ; cycling peak power output ; and self-efficacy . Conversely , AEROBIC improved indicators of cardiorespiratory fitness only . Cycling plus PRT produced larger effects than either single modality for mobility and impairment outcomes . CONCLUSION Single-modality exercises targeted at existing impairments do not optimally address the functional deficits of walking but do ameliorate the underlying impairments . The underlying cardiovascular and musculoskeletal impairments are significantly modifiable years after stroke with targeted robust exercise",
"OBJECTIVE To determine whether progressive resistance training improves muscle strength , muscle endurance , and physical function in adults with Down syndrome . DESIGN Single-blind r and omized controlled trial . SETTING General community . PARTICIPANTS Adults ( N=20 ) with Down syndrome ( 13 men , 7 women ; mean age , 26.8+/-7.8 y ) were r and omly assigned through a concealed allocation block r and omized method to either an intervention group ( n=9 ) or a control group ( n=11 ) . INTERVENTION The intervention was a supervised , group progressive resistance training program , consisting of 6 exercises using weight machines performed twice a week for 10 weeks . Participants completed 2 to 3 sets of between 10 to 12 repetitions of each exercise until they reached fatigue . The control group continued with their usual activities . MAIN OUTCOME MEASURES The outcomes measured by blinded assessors were muscle strength ( 1-repetition maximum [ 1-RM ] ) , muscle endurance ( number of repetitions at 50 % of 1-RM ) for chest press and leg press , timed stairs test , and the grocery shelving task . RESULTS The intervention group showed significant improvement in upper-limb muscle endurance compared with the control group ( mean difference in the number of repetitions of the chest press at 50 % of 1-RM was 16.7 , 95 % confidence interval , [ CI ] 7.1 - 26.2 ) ; and a trend toward an improvement in upper-limb muscle strength ( mean difference in chest press 1-RM , 8.6 kg ; 95 % CI , -1.3 to 18.5 kg ) and in upper-limb function ( mean difference in grocery shelving task , -20.3s ; 95 % CI , -45.7 to 5.2s ) . There were no significant differences between the groups for lower-limb muscle performance or physical function measures . No major adverse events for the intervention were noted . CONCLUSIONS Progressive resistance training is a safe and feasible fitness option that can improve upper-limb muscle endurance in adults with Down syndrome ( ACTR identifier ACTRN 012606000515594 . )",
"Background : Resistance training studies in multiple sclerosis ( MS ) often use short intervention periods . Furthermore , training efficiency could be optimized by unilateral training and /or electrical stimulation . Objective : To examine the effect(s ) of unilateral long-term ( 20 weeks ) st and ardized resistance training with and without simultaneous electro-stimulation on leg muscle strength and overall functional mobility . Methods : A r and omized controlled trial involving 36 persons with MS . At baseline ( PRE ) and after 10 ( MID ) and 20 ( POST ) weeks of st and ardized ( ACSM ) light to moderately intense unilateral leg resistance training ( RESO , n = 11 ) only or resistance training with simultaneous electro-stimulation ( RESE , n = 11 , 100 Hz , biphasic symmetrical wave , 400 µs ) , maximal isometric strength of the knee extensors and flexors ( 45 ° , 90 ° knee angle ) and dynamic ( 60–180 ° /s ) knee-extensor strength was measured and compared with a control group ( CON , n = 14 ) . Functional mobility was evaluated using the Timed Get Up and Go , Timed 25 Foot Walk , Two-Minute Walk Test , Functional Reach and Rivermead Mobility Index . Results : Maximal isometric knee extensor ( 90 ° , MID : + 10 ± 3 % , POST : + 10 ± 4 % ) in RESO and knee flexor ( 45 ° , POST : + 7 ± 4 % ; 90 ° , POST : + 9 ± 5 % ) in RESE strength increased ( p resistance training ( unilateral leg strength analysis ) and functional reaching increased significantly in RESO ( + 18 % ) compared with CON . Dynamic muscle strength and the remaining functional mobility tests did not change . Conclusion : Long-term light to moderately intense resistance training improves muscle strength in persons with MS but simultaneous electro-stimulation does not further improve training outcome",
"BACKGROUND AND PURPOSE Rehabilitation care after stroke is highly variable and increasingly shorter in duration . The effect of therapeutic exercise on impairments and functional limitations after stroke is not clear . The objective of this study was to determine whether a structured , progressive , physiologically based exercise program for subacute stroke produces gains greater than those attributable to spontaneous recovery and usual care . METHODS This r and omized , controlled , single-blind clinical trial was conducted in a metropolitan area and 17 participating healthcare institutions . We included persons with stroke who were living in the community . One hundred patients ( mean age , 70 years ; mean Orpington score , 3.4 ) consented and were r and omized from a screened sample of 582 . Ninety-two subjects completed the trial . Intervention was a structured , progressive , physiologically based , therapist-supervised , in-home program of thirty-six 90-minute sessions over 12 weeks targeting flexibility , strength , balance , endurance , and upper-extremity function . Main outcome measures were postintervention strength ( ankle and knee isometric peak torque , grip strength ) , upper- and lower-extremity motor control ( Fugl Meyer ) , balance ( Berg and functional reach ) , endurance ( peak aerobic capacity and exercise duration ) , upper-extremity function ( Wolf Motor Function Test ) , and mobility ( timed 10-m walk and 6-minute walk distance ) . RESULTS In the intention-to-treat multivariate analysis of variance testing the overall effect , the intervention produced greater gains than usual care ( Wilk 's lambda=0.64 , P=0.0056 ) . Both intervention and usual care groups improved in strength , balance , upper- and lower-extremity motor control , upper-extremity function , and gait velocity . Gains for the intervention group exceeded those in the usual care group in balance , endurance , peak aerobic capacity , and mobility . Upper-extremity gains exceeded those in the usual care group only in patients with higher baseline function . CONCLUSIONS This structured , progressive program of therapeutic exercise in persons who had completed acute rehabilitation services produced gains in endurance , balance , and mobility beyond those attributable to spontaneous recovery and usual care",
"Background and Purpose : Resistance exercise via negative , eccentrically induced work ( RENEW ) has been shown to be associated with improvements in strength , mobility , and balance in multiple clinical population s. However , RENEW has not been reported for individuals with multiple sclerosis ( MS ) . Methods : Nineteen individuals with MS ( 8 men , 11 women ; age mean = 49 ± 11 years ; Exp and ed Disability Status Scale [ EDSS ] mean = 5.2 ± 0.9 ) were r and omized into either st and ard exercise ( ST AND ) or st and ard exercise and RENEW training ( RENEW ) for 3 × /week for 12 weeks . Outcome measures were lower extremity strength ( hip/knee flexion and extension , ankle plantar and dorsiflexion , and the sum of these individual values [ sum strength ] ) ; Timed Up and Go ( TUG ) , 10-m walk , self-selected pace ( TMWSS ) and maximal-pace ( TMWMP ) , stair ascent ( S-A ) and descent ( S-D ) and 6-Minute Walk Test ( 6MWT ) , Berg Balance Scale ( BBS ) , Fatigue Severity Scale ( FSS ) . Results : No significant time effects or interactions were observed for strength , TUG , TMWSS , TMWMP , or 6MWT . However , the mean difference in sum strength in the RENEW group was 38.60 ( representing a 15 % increase ) compared to the sum strength observed in the ST AND group with a mean difference of 5.58 ( a 2 % increase ) . A significant interaction was observed for S-A , S-D , and BBS as the ST AND group improved whereas the RENEW group did not improve in these measures . Discussion and Conclusions : Contrary to results in other population s , the addition of eccentric training to st and ard exercises did not result in significantly greater lower extremity strength gains in this group of individuals with MS . Further this training was not as effective as st and ard exercise alone in improving balance or the ability to ascend and descend stairs . Following data collection , re assessment of required sample size indicates we were likely underpowered to detect strength differences between groups",
"BACKGROUND Patients with Parkinson 's disease have substantially impaired balance , leading to diminished functional ability and an increased risk of falling . Although exercise is routinely encouraged by health care providers , few programs have been proven effective . METHODS We conducted a r and omized , controlled trial to determine whether a tailored tai chi program could improve postural control in patients with idiopathic Parkinson 's disease . We r and omly assigned 195 patients with stage 1 to 4 disease on the Hoehn and Yahr staging scale ( which ranges from 1 to 5 , with higher stages indicating more severe disease ) to one of three groups : tai chi , resistance training , or stretching . The patients participated in 60-minute exercise sessions twice weekly for 24 weeks . The primary outcomes were changes from baseline in the limits-of-stability test ( maximum excursion and directional control ; range , 0 to 100 % ) . Secondary outcomes included measures of gait and strength , scores on functional-reach and timed up- and -go tests , motor scores on the Unified Parkinson 's Disease Rating Scale , and number of falls . RESULTS The tai chi group performed consistently better than the resistance-training and stretching groups in maximum excursion ( between-group difference in the change from baseline , 5.55 percentage points ; 95 % confidence interval [ CI ] , 1.12 to 9.97 ; and 11.98 percentage points ; 95 % CI , 7.21 to 16.74 , respectively ) and in directional control ( 10.45 percentage points ; 95 % CI , 3.89 to 17.00 ; and 11.38 percentage points ; 95 % CI , 5.50 to 17.27 , respectively ) . The tai chi group also performed better than the stretching group in all secondary outcomes and outperformed the resistance-training group in stride length and functional reach . Tai chi lowered the incidence of falls as compared with stretching but not as compared with resistance training . The effects of tai chi training were maintained at 3 months after the intervention . No serious adverse events were observed . CONCLUSIONS Tai chi training appears to reduce balance impairments in patients with mild-to-moderate Parkinson 's disease , with additional benefits of improved functional capacity and reduced falls . ( Funded by the National Institute of Neurological Disorders and Stroke ; Clinical Trials.gov number , NCT00611481 . )",
"Background and Purpose — To evaluate the efficacy of supervised high-intensity progressive resistance training ( PRT ) on lower extremity strength , function , and disability in older , long-term stroke survivors . Methods — Forty-two volunteers aged 50 years and above , 6 months to 6 years after a single mild to moderate stroke , were r and omized into either a control group of upper extremity stretching or a PRT group that received a 12-week supervised high-intensity resistance training program consisting of bilateral leg press ( LP ) , unilateral paretic and nonparetic knee extension ( KE ) , ankle dorsiflexion ( DF ) , and plantarflexion ( PF ) exercises . Functional performance was assessed using the 6-minute walk , stair-climb time , repeated chair-rise time , and habitual and maximal gait velocities . Self-reported changes in function and disability were evaluated using the Late Life Function and Disability Instrument ( LLFDI ) . Results — Single-repetition maximum strength significantly improved in the PRT group for LP ( 16.2 % ) , paretic KE ( 31.4 % ) , and nonparetic KE ( 38.2 % ) with no change in the control group . Paretic ankle DF ( 66.7 % versus −24.0 % ) , paretic ankle PF ( 35.5 % versus −20.3 % ) , and nonparetic ankle PF ( 14.7 % versus −13.8 % ) significantly improved in the PRT group compared with the control . The PRT group showed significant improvement in self-reported function and disability with no change in the control . There was no significant difference between groups for any performance-based measure of function . Conclusions — High-intensity PRT improves both paretic and nonparetic lower extremity strength after stroke , and results in reductions in functional limitations and disability",
"OBJECTIVE To evaluate the impact of a program of muscle strengthening and physical conditioning on impairment and disability in chronic stroke subjects . DESIGN A r and omized pretest and posttest control group , followed by a single-group pretest and posttest design . SUBJECTS Thirteen community-dwelling stroke survivors of at least 9 months . INTERVENTION A 10-week ( 3 days/week ) program consisting of a warm-up , aerobic exercises , lower extremity muscle strengthening , and a cool-down . MAIN OUTCOME MEASURES Peak isokinetic torque of the major muscle groups of the affected lower limb , quadriceps and ankle plantarflexor spasticity , gait speed , rate of stair climbing , the Human Activity Profile ( HAP ) , and the Nottingham Health Profile ( NHP ) were recorded twice for the treatment group and three times for the control group . RESULTS Significant improvements were found for all the selected outcome measures ( HAP , NHP , and gait speed ) for the treatment group ( p strength of the affected major muscle groups , in HAP and NHP profiles , and in gait speed and rate of stair climbing without concomitant increases in either quadriceps or ankle plantarflexor spasticity . CONCLUSIONS The 10-week combined program of muscle strengthening and physical conditioning result ed in gains in all measures of impairment and disability . These gains were not associated with measurable changes of spasticity in either quadriceps or ankle plantarflexors",
"OBJECTIVE The aim of this study was to evaluate the effect on spasticity , muscle strength and motor performance after 8 weeks of whole-body vibration training compared with resistance training in adults with cerebral palsy . METHODS Fourteen persons with spastic diplegia ( 21 - 41 years ) were r and omized to intervention with either whole-body vibration training ( n=7 ) or resistance training ( n=7 ) . Pre- and post-training measures of spasticity using the modified Ashworth scale , muscle strength using isokinetic dynamometry , walking ability using Six-Minute Walk Test , balance using Timed Up and Go test and gross motor performance using Gross Motor Function Measure were performed . RESULTS Spasticity decreased in knee extensors in the whole-body vibration group . Muscle strength increased in the resistance training group at the velocity 30 degrees /s and in both groups at 90 degrees /s . Six-Minute Walk Test and Timed Up and Go test did not change significantly . Gross Motor Function Measure increased in the whole-body vibration group . CONCLUSION These data suggest that an 8-week intervention of whole-body vibration training or resistance training can increase muscle strength , without negative effect on spasticity , in adults with cerebral palsy",
"BACKGROUND AND PURPOSE Little is known about the relative efficacy of supervised versus unsupervised community exercise programs for stroke survivors . This study compared the effectiveness of a 10-week supervised strengthening and conditioning program ( supervised ) with a 1-week supervised instruction program followed by a 9-week unsupervised home program ( unsupervised ) and evaluated retention of changes at 6 months and 1 year after program completion . METHODS Seventy-two subjects retained at baseline ( 27 women , 45 men ; mean+/-SD age , 64.6+/-11.8 years ) were r and omly allocated to receive the supervised or unsupervised program . The primary outcome was walking speed over 6 minutes , and secondary outcome measures were Human Activity Profile , Medical Outcome Study 36-Item Short-Form survey ( SF-36 ) , Physiological Cost Index , and lower extremity muscle strength . RESULTS The 6-minute walking speed increased significantly in both groups and remained significantly improved by 1 year . The Human Activity Profile demonstrated an increasing trend only in the supervised group that was significant by 1 year . The SF-36 Physical Component summary score increased significantly in the supervised group and remained improved by 1 year ; the unsupervised group showed significant improvement at 1 year . Women made greater gains in supervised programs , but men made greater gains in unsupervised programs . CONCLUSIONS Supervised exercise programs and unsupervised programs after initial supervised instruction were both associated with physical benefits that were retained for 1 year , although supervised programs showed trends to greater improvements in self-reported gains . Gender differences require further research",
"BACKGROUND / PURPOSE Improvement in mobility function has been the primary goal in the rehabilitation of children with cerebral palsy . Few studies have examined the effectiveness of task-oriented strength training for children with cerebral palsy . The purpose of this study was to examine the effects of task-oriented strength training on mobility function in children with cerebral palsy . STUDY DESIGN A single-blind , r and omized controlled trial with pre-training and post-training evaluations . MATERIAL S AND METHODS Ten children with cerebral palsy ( GMFCS levels I-III ) were r and omly assigned to an experimental group ( N = 5 ) or control group ( N = 5 ) . Mobility function was assessed using the Gross Motor Function Measure ( GMFM ) and the Timed \" Up and Go \" ( TUG ) test . Participants in the control group received conventional physical therapy focused on improving walking and balance through facilitation and normalization of movement patterns . Participants in the experiment group received task-oriented strength training focused on strengthening the lower extremities and practicing functional tasks similar to those the child performs during daily activities . RESULTS After the 5-week training period there were significant improvements in the experimental group for dimension D ( p = 0.009 ) , and dimension E ( p = 0.009 ) of the GMFM . The experimental group significantly reduced the time taken to complete the TUG ( p = 0.017 ) . CONCLUSION / SIGNIFICANCE This study supports the efficacy of task-oriented strength training for improving mobility function in children with cerebral palsy . The findings demonstrate that the application of a task-oriented strength training program is linked to positive functional outcomes . The results suggest that children with cerebral palsy may benefit from a task-oriented strength training program . Further studies with a larger r and omized sample and longer post-intervention follow-up are necessary to document the long-term effects of participation in task-oriented strength training programs in the cerebral palsy population",
"This r and omized controlled trial with blinded assessment aim ed to determine the effect of a 6-month minimally supervised exercise program on fall risk factors in people with Parkinson 's disease ( PD ) . Forty-eight participants with PD who had fallen or were at risk of falling were r and omized into exercise or control groups . The exercise group attended a monthly exercise class and exercised at home three times weekly . The intervention targeted leg muscle strength , balance , and freezing . The primary outcome measure was a PD falls risk score . The exercise group had no major adverse events and showed a greater improvement than the control group in the falls risk score , which was not statistically significant ( between group mean difference = -7 % , 95 % CI -20 to 5 , P = 0.26 ) . There were statistically significant improvements in the exercise group compared with the control group for two secondary outcomes : Freezing of Gait Question naire ( P = 0.03 ) and timed sit-to-st and ( P = 0.03 ) . There were statistically nonsignificant trends toward greater improvements in the exercise group for measures of muscle strength , walking , and fear of falling , but not for the measures of st and ing balance . Further investigation of the impact of exercise on falls in people with PD is warranted",
"OBJECTIVE To evaluate the effects of progressive resistance training on muscle strength , muscle tone , gait performance and perceived participation after stroke . DESIGN A r and omized controlled trial . SUBJECTS Twenty-four subjects ( mean age 61 years ( st and ard deviation 5 ) ) 6 - 48 months post-stroke . METHODS The training group ( n = 15 ) participated in supervised progressive resistance training of the knee muscles ( 80 % of maximum ) twice weekly for 10 weeks , and the control group ( n = 9 ) continued their usual daily activities . Both groups were assessed before and after the intervention and at follow-up after 5 months . Muscle strength was evaluated dynamically and isokinetically ( 60 degrees /sec ) and muscle tone by the Modified Ashworth Scale . Gait performance was evaluated by Timed \" Up & Go \" , Fast Gait Speed and 6-Minute Walk tests , and perceived participation by Stroke Impact Scale . RESULTS Muscle strength increased significantly after progressive resistance training with no increase in muscle tone and improvements were maintained at follow-up . Both groups improved in gait performance , but at follow-up only Timed \" Up & Go \" and perceived participation were significantly better for the training group . CONCLUSIONS Progressive resistance training is an effective intervention to improve muscle strength in chronic stroke . There appear to be long-term benefits , but further studies are needed to clarify the effects , specifically of progressive resistance training on gait performance and participation",
"OBJECTIVE To examine the effects of an 8-week home-based resistance exercise program on balance , power , and mobility in adults with multiple sclerosis . DESIGN Experimental group design . SETTING General community . PARTICIPANTS Twenty-nine women ( age , 50.3+/-8.5 y ) and 8 men ( age , 51.1+/-7.1 y ) were stratified by disability level and age and were r and omized into exercise ( n=19 ) and control ( n=17 ) groups . INTERVENTION The exercise group had lower-extremity resistance training 3 times a week . The control group maintained current level of physical activity . Main outcome measures Primary outcome measures included balance , as measured by anteroposterior sway , mediolateral sway , and sway velocity using the AccuSway(PLUS ) force platform ; mobility as assessed with the Up and Go test ; and leg power as assessed with the Leg Extensor Power Rig . RESULTS Leg extensor power improved significantly in the exercise group ( pretest , 3.19+/-1.36 W/kg ; posttest , 3.95+/-1.23 W/kg ; P=.004 ) , although measures of balance and mobility did not change . CONCLUSIONS The home-based resistance program was well tolerated by participants and offered a practical means to improve leg extensor power in a short period of time",
"Objective : To establish the effects of a 12-week , community-based group exercise intervention for people moderately affected with multiple sclerosis . Design : R and omized controlled pilot trial . Setting : Two community leisure centres . Participants : Thirty-two participants with multiple sclerosis r and omized into intervention or control groups . Intervention : The intervention group received 12 weeks of twice weekly , 60-minute group exercise sessions , including mobility , balance and resistance exercises . The control group received usual care . Main outcome measures : An assessor blinded to group allocation assessed participants at baseline , after eight weeks and after 12 weeks . The primary outcome measure was 25-foot ( 7.6 m ) walk time , secondary outcomes assessed walking endurance , balance , physical function , leg strength , body mass index , activity levels , fatigue , anxiety and depression , quality of life and goal attainment . Results : The intervention made no statistically significant difference to the results of participants ’ 25-foot walk time . However the intervention led to many improvements . In the intervention group levels of physical activity improved statistically between baseline and week 8 ( P Balance confidence results showed a significant difference between baseline and week 12 ( P = 0.013 ) . Good effect sizes were found for dynamic balance ( d = 0.80 ) , leg strength ( d = 1.33 ) , activity levels ( d = 1.05 ) and perceived balance ( d = 0.94 ) . Conclusion : The results of the study suggest that community-based group exercise classes are a feasible option for people moderately affected with multiple sclerosis , and offer benefits such as improved physical activity levels , balance and leg strength",
"After stroke , physiotherapy can promote brain reorganization and motor recovery . Combining muscle strength and functional training ( functional strength training , FST ) may be beneficial . The aim of the authors was to compare FST with conventional physiotherapy ( CPT ) while controlling for the potential confounder of therapy intensity in a multicenter , r and omized controlled observer-blind trial . The mean age of the participants was 68.3 ( st and ard deviation [ SD ] = 12.03 ) years at a mean of 34 ( SD = 20 ) days after stroke , with mean peak paretic knee extension torque ( torque ) of 22 ( SD = 25 ) Nm . The estimated sample size was 102 to detect a between-group difference of 0.2 m/s in walking speed . After baseline measures , participants were allocated r and omly to CPT or CPT + CPT or CPT + FST for 6 weeks . Additional experimental therapy was provided for up to 1 hour a day , 4 times each week . Outcomes were measured 6 weeks after baseline and at follow-up 12 weeks thereafter . Measures included walking speed , knee extensor torque , and functional mobility ( Rivermead ) . At outcome , both extraintensity groups showed greater increases in walking speed than the CPT group , but this reached significance only for the CPT + CPT group ( P = .031 ) . The CPT + CPT group also had a greater number of participants who walked at 0.8 m/s or above . No significant differences were observed for torque about the knee or for the Rivermead score . At follow-up , no significant differences were observed . These phase I results justify a subsequent trial of CPT + CPT versus CPT + FST",
"Resistance training of the lower limbs is now commonly used in clinical practice in children and adolescents with spastic cerebral palsy ( CP ) . However , the effectiveness of this type of training is still disputed . The most recently published systematic review with meta- analysis included interventions such as electrical stimulation and resistance training and found insufficient evidence to support or refute the efficacy of these exercises in children with CP . Thus , the aim of this article is to evaluate the extent to which training protocol s from the most recent r and omized controlled trials are in keeping with the evidence for effective resistance training in children who are developing typically , as reflected in the training guidelines of the National Strength and Conditioning Association . Recommendations for resistance training protocol s , based on this evidence and appropriate to children with CP , are provided to help guide both future research and clinical practice for resistance training in children with CP",
"A r and omized clinical trial on the effects of strength training was performed in myotonic dystrophy ( MyD ) patients and patients with hereditary motor and sensory neuropathy ( HMSN ) . Training and most measurement tools involved the proximal lower extremity muscles . The participants trained 3 times a week for 24 weeks with weights adapted to their force . Strength was evaluated by isokinetically measured knee torque . Fatiguability was assessed by the time an isometric contraction could be sustained . Functional performance was measured by timed motor performance and by question naires on functional performance . Serum myoglobin ( Mb ) levels were determined to detect changes in muscle fiber membrane permeability . The MyD group included 33 participants , and the HMSN group included 29 participants . Within each diagnostic group , patients were individually matched and subsequently r and omized for treatment allocation . In the MyD patients , none of the measurement techniques showed any training effect . Neither were there signs of deterioration caused by the training . In the HMSN group , knee torques increased . Timed motor performance did not change , although the question naires showed an improvement on items related to upper-leg function . Mb levels did not change significantly as a result of the training . In conclusion , the MyD group showed neither positive nor negative effects of the training protocol , whereas the training produced a moderate increase in strength and leg-related functional performance in the HMSN group",
"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",
"The plantarflexor , hip extensor and hip flexor muscle groups contribute by their concentric action to generate most of the energy during level gait in healthy subjects . The goal of the present study was to determine , during the main energy generation phases , the relative dem and of these three groups in 14 healthy subjects walking at four cadences ( self-selected , 60 , 80 and 120 steps/min ) . The muscular utilization ratio ( MUR ) , that compares the net joint moment obtained during gait to the maximal potential moment ( MPM ) at each percentage of the gait cycle , was used to estimate the mechanical relative dem and . The MPM values were obtained by regression equations developed from torque data measured with a Biodex dynamometric system . The results showed that the peak MURs increased with gait cadence . The peak values were not significantly different between sides for all cadences despite mean absolute lateral differences ranging from 7 % to 10 % . The mean peak MURs of both sides ranged from 51.3 % to 62.6 % , from 20.7 % to 49.9 % and from 14.9 % to 42.5 % , for the plantarflexors , hip flexors and hip extensors , respectively . Highly significant associations were found between the MURs and net moments ( numerator of the MUR ratio ) , with Pearson coefficients ( r ) superior to 0.80 for all muscles groups . The association between the MURs and the maximal potential moments ( denominator of MUR ratio ) was lower ( 0.01 mechanical relative dem and during gait increased with gait cadence . The plantarflexor MUR values were always the highest . However , when gait cadence increased , the MURs at the hip reached similar values of those of the ankle , which suggests that these muscles also work significantly at elevated gait cadences . The changes in the MUR values were mainly explained by changes in the net joint moments",
"Persons with Parkinson disease ( PD ) often demonstrate bradykinesia during mobility tasks . Bradykinesia combined with other PD-related movement deficits may contribute to self-reported reductions in quality of life . At this time , no studies have examined the effects of resistance exercise as an intervention to reduce bradykinesia and improve self-reported quality of life . Therefore , we examined changes in muscle force production , clinical measures of bradykinesia , and quality of life following 12 weeks of a high intensity eccentric resistance exercise program in persons with mild to moderate PD . Twenty individuals with idiopathic PD were matched into an experimental or an active control group . All participants were tested prior to and following a 12-week intervention period . The experimental group performed high intensity quadriceps contractions on an eccentric ergometer 3 days a week for 12 weeks . The active control group participated in an evidence based exercise program of PD . The outcome variables were quadriceps muscle force , clinical bradykinesia measures ( gait speed , timed up and go ) and disease specific quality of life ( Parkinson 's disease question naire-39 [ PDQ-39 ] ) . Data was analyzed using separate 2 ( group ) x 2 ( time period ) ANOVAs . Results demonstrated significant time by group interaction effects for gait speed , timed up and go , and the composite PDQ-39 score ( p Muscle force , bradykinesia , and QOL were improved to a greater degree in those that performed high intensity eccentric resistance training compared to an active control group . Additional research is needed to determine if this type of training has long-term impact and if it results in an alteration of the natural history of mobility and QOL decline in persons with PD",
"Background : Few high- quality trials have examined the effects of progressive resistance training ( PRT ) on people with multiple sclerosis ( MS ) . Objective : To determine the effectiveness of PRT for people with MS , focusing on improving the gait deficits common in this population . Methods : Using a single blind r and omized controlled trial , people with relapsing – remitting MS were r and omly allocated to either a PRT program targeting the lower limb muscles twice a week for 10 weeks ( n = 36 ) , or usual care plus an attention and social program conducted once a week for 10 weeks ( n = 35 ) . Outcomes were recorded at baseline , week 10 and week 22 . Results : Participants attended 92 % of training sessions , with no serious adverse events . At 10 weeks , no differences were detected in walking performance . However , compared with the comparison group PRT demonstrated increased leg press strength ( 16.8 % , SD 4.5 ) , increased reverse leg press strength ( 29.8 % , SD 12.7 ) , and increased muscle endurance of the reverse leg press ( 38.7 % , SD 32.8 ) . Improvements in favor of PRT were also found for physical fatigue ( Mean difference −3.9 units , 95%CI −6.6 to −1.3 ) , and the physical health domain of quality of life ( Mean difference 1.5 units , 95%CI 0.1 to 2.9 ) . At week 22 almost no between-group differences remained . Conclusion : PRT is a relatively safe intervention that can have short-term effects on reducing physical fatigue , increasing muscle endurance and can lead to small improvements in muscle strength and quality of life in people with relapsing – remitting MS . However , no improvements in walking performance were observed and benefits do not appear to persist if training is completely stopped",
"OBJECTIVE To determine , using the Muscular Utilization Ratio ( MUR ) method , whether plantarflexor weakness is among the factors preventing stroke subjects from walking at faster speeds . Potential compensations by the hip flexors were also examined . DESIGN A convenience sample of 17 chronic stroke subjects in a context of a descriptive study . BACKGROUND Gait speed is correlated with the residual strength of the muscles involved in gait in stroke subjects . However , it has not been established if this residual strength limits gait speed . METHODS Kinetic and kinematic data for comfortable and maximal gait speeds were collected on the paretic side , and were used to determine the moments in plantarflexion ( mechanical dem and : MUR numerator ) during the push-off phase . The maximal potential moment ( MUR denominator ) of the plantarflexors during gait was predicted using an equation derived from dynamometric data collected with a Biodex system . The MURs of the plantarflexors were then calculated at every 1 % interval of the push-off phase . The pull-off phase of gait and the hip flexor strength were also examined . RESULTS Ten subjects of the sample had a MUR value between 80 and 150 % at maximal gait speed . These subjects produced the lowest peak torques in plantarflexion . Each of the four fastest subjects of this group had a large hip flexion moment during the pull-off phase of gait and produced high hip flexion torque values on the dynamometer . Each of the seven remaining subjects had a MUR value under 70 % when they walked at maximal speed . CONCLUSIONS Weakness of the plantarflexors should be considered as one factor limiting gait speed in 10 hemiparetic subjects . Some subjects with weak plantarflexors could walk rapidly because they compensated with the hip flexors . For the remaining stroke subjects , factors other than weakness of the plantarflexors have to be considered in order to explain the reduction in their gait speed",
"OBJECTIVES The goal most often stated by persons with stroke is improved walking function . The purpose of this study was to determine the effects of isokinetic strength training on walking performance , muscle strength , and health-related quality of life in survivors of chronic stroke . METHODS Twenty participants ( age , 61.2 + /- 8.4 years ) with chronic stroke were r and omized into 2 groups . The experimental group undertook maximal concentric isokinetic strength training , whereas the control group received passive range of motion of the paretic lower extremity 3 times a week for 6 weeks . The Kin-Com Isokinetic Dynamometer ( Chattanooga Group Inc. , TN ) was used for both the strengthening and passive range of motion exercises . The Mann-Whitney U test was used to compare the changes in scores ( postintervention minus baseline ) between the control and experimental groups for a composite lower extremity strength score , walking speed ( level-walking and stair-walking ) and health-related quality of life measure ( 36-Item Short Form Health Survey [ SF-36 ] ) . RESULTS Both the experimental and control groups increased their strength and walking speed postintervention ; however , there were no differences in the changes in walking speed between the groups . There was a trend ( P = .06 ) toward greater strength improvement in the experimental group compared with the control group . No changes in SF-36 scores were found in either group . CONCLUSIONS Intervention aim ed at increasing strength did not result in improvements in walking . The results of this study stress the importance of controlled clinical trials in determining the effect of specific treatment approaches . Strength training in conjunction with other task-related training may be indicated",
"Objective : To examine the effectiveness of task-oriented progressive resistance strength training on lower extremity strength and functional performance in chronic stroke subjects . Design : Single-blind , r and omized controlled trial . Setting : Medical centre and district hospital . Subjects : Forty-eight subjects at least one year post stroke . Interventions : Participants r and omly allocated to two groups , control ( n-/24 ) and experimental ( n-/24 ) . Subjects in the control group did not receive any rehabilitation training . Subjects in the experimental group were put on a four-week task-oriented progressive resistance strength training . Main measures : Lower extremity muscle strength , gait velocity , cadence , stride length , six-minute walk test , step test , and timed up and go test . Results : Muscle strength significantly improved in the experimental group for strong side muscle groups ( ranged from 23.9 % to 36.5 % ) and paretic side muscle groups ( ranged from 10.1 % to 77.9 % ) . In the control group muscle strength changes ranged from 6.7 % gain to 11.2 % decline . The experimental group showed significant improvement in all selected measures of functional performance except for the step test . In the control group , the number of repetitions of the step test significantly decreased ( -20.3 % ) with no change in other functional tests . There was a significant difference between groups for muscle strength and all functional measures . The strength gain was significantly associated with gain in the functional tests . Conclusions : The task-oriented progressive resistance strength training programme could improve lower extremity muscle strength in individuals with chronic stroke and could carry over into improvement in functional abilities"
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OBJECTIVE To systematic ally review whether the provision of information on cardiovascular disease ( CVD ) risk to healthcare professionals and patients impacts their decision-making , behaviour and ultimately patient health . DESIGN A systematic review . DATA SOURCES An electronic literature search of MEDLINE and PubMed from 01/01/2004 to 01/06/2013 with no language restriction and manual screening of reference lists of systematic review s on similar topics and all included papers . ELIGIBILITY CRITERIA FOR SELECTING STUDIES ( 1 ) Primary research published in a peer- review ed journal ; ( 2 ) inclusion of participants with no history of CVD ; ( 3 ) intervention strategy consisted of provision of a CVD risk model estimate to either professionals or patients ; and ( 4 ) the only difference between the intervention group and control group ( or the only intervention in the case of before-after studies ) was the provision of a CVD risk model estimate . RESULTS After duplicates were removed , the initial electronic search identified 9671 papers . We screened 196 papers at title and abstract level and included 17 studies . The heterogeneity of the studies limited the analysis , but together they showed that provision of risk information to patients improved the accuracy of risk perception without decreasing quality of life or increasing anxiety , but had little effect on lifestyle . Providing risk information to physicians increased prescribing of lipid-lowering and blood pressure medication , with greatest effects in those with CVD risk > 20 % ( relative risk for change in prescribing 2.13 ( 1.02 to 4.63 ) and 2.38 ( 1.11 to 5.10 ) respectively ) . Overall , there was a trend towards reductions in cholesterol and blood pressure and a statistically significant reduction in modelled CVD risk ( -0.39 % ( -0.71 to -0.07 ) ) after , on average , 12 months . CONCLUSIONS There seems evidence that providing CVD risk model estimates to professionals and patients improves perceived CVD risk and medical prescribing , with little evidence of harm on psychological well-being
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"Objective To derive a new cardiovascular disease risk score ( QRISK ) for the United Kingdom and to vali date its performance against the established Framingham cardiovascular disease algorithm and a newly developed Scottish score ( ASSIGN ) . Design Prospect i ve open cohort study using routinely collected data from general practice . Setting UK practice s contributing to the Q RESEARCH data base . Participants The derivation cohort consisted of 1.28 million patients , aged 35 - 74 years , registered at 318 practice s between 1 January 1995 and 1 April 2007 and who were free of diabetes and existing cardiovascular disease . The validation cohort consisted of 0.61 million patients from 160 practice s. Main outcome measures First recorded diagnosis of cardiovascular disease ( incident diagnosis between 1 January 1995 and 1 April 2007 ) : myocardial infa rct ion , coronary heart disease , stroke , and transient ischaemic attacks . Risk factors were age , sex , smoking status , systolic blood pressure , ratio of total serum cholesterol to high density lipoprotein , body mass index , family history of coronary heart disease in first degree relative aged less than 60 , area measure of deprivation , and existing treatment with antihypertensive agent . Results A cardiovascular disease risk algorithm ( QRISK ) was developed in the derivation cohort . In the validation cohort the observed 10 year risk of a cardiovascular event was 6.60 % ( 95 % confidence interval 6.48 % to 6.72 % ) in women and 9.28 % ( 9.14 % to 9.43 % ) in men . Overall the Framingham algorithm over-predicted cardiovascular disease risk at 10 years by 35 % , ASSIGN by 36 % , and QRISK by 0.4 % . Measures of discrimination tended to be higher for QRISK than for the Framingham algorithm and it was better calibrated to the UK population than either the Framingham or ASSIGN models . Using QRISK 8.5 % of patients aged 35 - 74 are at high risk ( 20 % risk or higher over 10 years ) compared with 13 % when using the Framingham algorithm and 14 % when using ASSIGN . Using QRISK 34 % of women and 73 % of men aged 64 - 75 would be at high risk compared with 24 % and 86 % according to the Framingham algorithm . UK estimates for 2005 based on QRISK give 3.2 million patients aged 35 - 74 at high risk , with the Framingham algorithm predicting 4.7 million and ASSIGN 5.1 million . Overall , 53 668 patients in the validation data set ( 9 % of the total ) would be reclassified from high to low risk or vice versa using QRISK compared with the Framingham algorithm . Conclusion QRISK performed at least as well as the Framingham model for discrimination and was better calibrated to the UK population than either the Framingham model or ASSIGN . QRISK is likely to provide more appropriate risk estimates to help identify high risk patients on the basis of age , sex , and social deprivation . It is therefore likely to be a more equitable tool to inform management decisions and help ensure treatments are directed towards those most likely to benefit . It includes additional variables which improve risk estimates for patients with a positive family history or those on antihypertensive treatment . However , since the validation was performed in a similar population to the population from which the algorithm was derived , it potentially has a “ home advantage . ” Further validation in other population s is therefore required",
"Objectives Hypertension is common among patients with dyslipidemia but is often poorly treated . The objective of this analysis was to evaluate how a decision aid , used by primary care physicians to improve lipid therapy , impacted on the treatment of hypertension . Study Design Data were analyzed from patients enrolled in a r and omized trial focusing primarily on the treatment of dyslipidemia . Patients received usual care or a coronary risk profile every three months to monitor the risk reduction following lifestyle changes and /or pharmacotherapy to treat dyslipidemia . Hypertension management was assessed based on a post hoc analysis of individuals whose blood pressure exceeded current national hypertension guidelines . Results There were 2,631 subjects who completed the study . Among 1,352 patients without diagnosed hypertension , 30 % were above target on at least three consecutive visits . Among 1,279 individuals with known hypertension , 69 % were above target on at least two consecutive visits . Overall , patients receiving risk profiles were more likely to receive appropriate antihypertensive therapy ( OR = 1.40 , 95 % CI 1.11 – 1.78 ) compared to those receiving usual care . After adjustment for inter-physician variability and potential confounders , the use of the risk profile was associated with an increased likelihood of starting therapy ( OR = 1.78 , 95 % CI 1.06 – 3.00 ) or modifying therapy ( OR = 1.40 , 95 % CI 1.03 – 1.91 ) . Conclusions In this clinical trial of dyslipidemia management , inadequately controlled hypertension was common , occurring in nearly 50 % of individuals . Ongoing coronary risk assessment was associated with more appropriate blood pressure management . Cardiovascular risk assessment decision aids should be further evaluated in a r and omized trial of hypertension therapy",
"Cardiovascular disease causes the death of around 80 % of patients with type 2 diabetes.1 However , risk factors for cardiovascular disease in such patients are often untreated2 despite the proved benefits of intervention . 3 4 One way to help clinicians identify patients at high risk of cardiovascular disease is to use cardiovascular primary prevention risk tables . These tables integrate the multiple risk factors into a single score . We did a pilot study to test the hypothesis that documentation of a cardiovascular risk score in the case notes would improve the management of cardiovascular risk factors . We recruited patients with type 2 diabetes who had no history of cardiovascular disease or renal disease . All patients were aged 35–75 years and attending a hospital",
"OBJECTIVES Based on the data of the Prospect i ve Cardiovascular Münster ( PROCAM ) study , a prospect i ve study of men and women at work in the north-west of Germany , we aim ed ( i ) to develop a refined scoring scheme for calculating the risk of acute coronary events among adult and elderly men and women ; and ( ii ) to generate a new scoring scheme for calculating the risk of ischaemic stroke or transient ischaemic attack ( TIA ) . METHODS The coronary risk score was derived from a Weibull function using data from 18 460 men and 8515 women who were recruited before 1996 and had a mean follow-up period of 12+/-6 years . The stroke score was derived using a Cox proportional hazards model using data of 5905 men and 2225 women aged 35 - 65 years with at least 10 years of unbroken follow-up . RESULTS The coronary risk score was based on 511 major coronary events , 462 ( 168 fatal , 294 non-fatal ) in men and 49 ( 18 fatal , 31 non-fatal ) in women and included the risk factors LDL cholesterol , HDL cholesterol , systolic blood pressure , smoking status , triglycerides and diabetes mellitus status . It was accurate in both sexes over an age range from 20 to 75 years with an area under the receiver-operating characteristics ( ROC ) curve of 0.82 . The stroke score was based on 85 cerebral ischaemic events ( 21 TIAs , 64 ischaemic strokes ) and included the risk factors age , sex , diabetes mellitus status , smoking status and systolic blood pressure . It had an area under the ROC curve of 0.78 and identified a high-risk group comprising only 4 % of the study population that contained 31 % of all cerebral ischaemic events . CONCLUSION Both new PROCAM risk scores provide simple and effective ways to assess the risk of acute coronary events and ischaemic stroke in the general population and will improve the ability of physicians to target measures in an effort to prevent these potentially devastating conditions",
"BACKGROUND The Coronary Health Assessment Study ( CHAS ) was developed to determine the feasibility of using patient-specific , multifactorial computerized coronary risk profiles as a clinical decision aid to support primary prevention of CHD . METHODS Study participants included 253 community based physicians , r and omized into profile and control groups , and 958 of their patients . The profile group physicians received coronary risk profiles for their patients within 10 working days after the baseline patient assessment providing early feedback . The control group received their profiles only if the patient was clinical ly reevaluated during a 3-month follow-up visit . Patients ' coronary risk factors were evaluated at baseline and at follow-up . RESULTS The profile group had a significantly higher ( P ratio of high-risk/low-risk patients who returned for a follow-up visit compared to the control group ( 1.23 vs 0.77 ) . The patients in the profile group also had significantly ( P reductions in total cholesterol ( -0.5 vs -0.1 mmol/L ) , LDL cholesterol ( -0.4 vs 0.0 mmol/L ) , the total cholesterol/ HDL ratio ( -0.6 vs -0.2 ) , and the predicted 8-year coronary risk ( -1.8 vs -0.3 % ) . CONCLUSIONS Computer-generated coronary risk profiles can be effective in assisting physicians to identify high-risk patients . Their use is also associated with significantly greater improvements in the serum lipid profiles and the overall coronary risk of these patients",
"Objective : To improve equity in cardiovascular disease prevention by developing a cardiovascular risk score including social deprivation and family history . Design : The ASSIGN score was derived from cardiovascular outcomes in the Scottish Heart Health Extended Cohort ( SHHEC ) . It was tested against the Framingham cardiovascular risk score in the same data base . Setting : R and om- sample , risk-factor population surveys across Scotl and 1984–87 and North Glasgow 1989 , 1992 and 1995 . Participants : 6540 men and 6757 women aged 30–74 , initially free of cardiovascular disease , ranked for social deprivation by residence postcode using the Scottish Index of Multiple Deprivation ( SIMD ) and followed for cardiovascular mortality and morbidity through 2005 . Results : Classic risk factors , including cigarette dosage , plus deprivation and family history but not obesity , were significant factors in constructing ASSIGN scores for each sex . ASSIGN scores , lower on average , correlated closely with Framingham values for 10-year cardiovascular risk . Discrimination of risk in the SHHEC population was significantly , but marginally , improved overall by ASSIGN . However , the social gradient in cardiovascular event rates was inadequately reflected by the Framingham score , leaving a large social disparity in future victims not identified as high risk . ASSIGN classified more people with social deprivation and positive family history as high risk , anticipated more of their events , and abolished this gradient . Conclusion : Conventional cardiovascular scores fail to target social gradients in disease . By including unattributed risk from deprivation , ASSIGN shifts preventive treatment towards the socially deprived . Family history is valuable not least as an approach to ethnic susceptibility . ASSIGN merits further evaluation for clinical use",
"AIMS To estimate the potential effectiveness of different \" high-risk \" and \" population \" approaches to the primary prevention of cardiovascular disease ( CVD ) in middle-aged British men , after correction for regression dilution bias . METHODS AND RESULTS We used a combination of cohort and r and omised controlled trial evidence to estimate the effectiveness of high-risk strategies , based on the identification of high-risk factors or high absolute risk , and strategies based on population -wide reductions in cholesterol and blood pressure . High-risk strategies were potentially effective but would need to be used widely to have a substantial effect on CVD in the population . Aggressive pharmacological treatment ( using statins , beta-blockers , ACE-inhibitors and aspirin ) in individuals with a 10-year Framingham event risk of > or=30 % ( 6 % of population ) would have reduced major CVD by at most 11 % . This figure increased to 34 % at a > or=20 % treatment threshold ( 26 % of population ) . In contrast , modest downwards shifts in the population distributions of serum total cholesterol and systolic blood pressure led to marked expected reductions in major CVD . Taking regression dilution bias into account , 10 % reductions in long-term mean blood cholesterol and blood pressure could have reduced major CVD by 45 % . CONCLUSIONS If high-risk strategies are to have a major impact on CVD in the population , they need to be more widely used than previously envisaged . Population -wide reduction of major risk factors is needed if CVD is to be substantially reduced",
"CONTEXT Despite improved underst and ing of atherothrombosis , cardiovascular prediction algorithms for women have largely relied on traditional risk factors . OBJECTIVE To develop and vali date cardiovascular risk algorithms for women based on a large panel of traditional and novel risk factors . DESIGN , SETTING , AND PARTICIPANTS Thirty-five factors were assessed among 24 558 initially healthy US women 45 years or older who were followed up for a median of 10.2 years ( through March 2004 ) for incident cardiovascular events ( an adjudicated composite of myocardial infa rct ion , ischemic stroke , coronary revascularization , and cardiovascular death ) . We used data among a r and om two thirds ( derivation cohort , n = 16 400 ) to develop new risk algorithms that were then tested to compare observed and predicted outcomes in the remaining one third of women ( validation cohort , n = 8158 ) . MAIN OUTCOME MEASURE Minimization of the Bayes Information Criterion was used in the derivation cohort to develop the best-fitting parsimonious prediction models . In the validation cohort , we compared predicted vs actual 10-year cardiovascular event rates when the new algorithms were compared with models based on covariates included in the Adult Treatment Panel III risk score . RESULTS In the derivation cohort , a best-fitting model ( model A ) and a clinical ly simplified model ( model B , the Reynolds Risk Score ) had lower Bayes Information Criterion scores than models based on covariates used in Adult Treatment Panel III . In the validation cohort , all measures of fit , discrimination , and calibration were improved when either model A or B was used . For example , among participants without diabetes with estimated 10-year risks according to the Adult Treatment Panel III of 5 % to less than 10 % ( n = 603 ) or 10 % to less than 20 % ( n = 156 ) , model A reclassified 379 ( 50 % ) into higher- or lower-risk categories that in each instance more accurately matched actual event rates . Similar effects were achieved for clinical ly simplified model B limited to age , systolic blood pressure , hemoglobin A(1c ) if diabetic , smoking , total and high-density lipoprotein cholesterol , high-sensitivity C-reactive protein , and parental history of myocardial infa rct ion before age 60 years . Neither new algorithm provided substantive information about women at very low risk based on the published Adult Treatment Panel III score . CONCLUSION We developed , vali date d , and demonstrated highly improved accuracy of 2 clinical algorithms for global cardiovascular risk prediction that reclassified 40 % to 50 % of women at intermediate risk into higher- or lower-risk categories",
"Aims A prospect i ve study was conducted to identify the psychological impact of labelling middle-aged men as having above average risk for coronary heart disease . A second aim was to find out the psychological effect of participation in a subsequent clinical trial . Methods 5813 men attended nine special screening clinics in Engl and and Scotl and for baseline measurement of psychological symptoms and coronary disease risk factors . Each man was later informed of his risk status by letter as either above average risk ( high-risk ) or no special risk ( low-risk ) . In three clinics some men also received an intermediate risk ( moderate-risk ) between high-risk and low-risk . Follow-up psychological measurements were made after labelling and 3 months later . Results Men who received either the high-risk label ( n = 838 ) or the low-risk label ( n = 3114 ) showed a decrease in reported psychological symptoms after labelling . Men receiving the unexpected intermediate risk ( moderate-risk ) label , which communicated specific test abnormalities , increased their psychological symptoms to ‘ case ’ levels on the General Health Question naire ; relative risk ( compared with low-risk ) was 1.80 ( 95 % confidence interval 1.19 - 2,71 ) after adjustment for confounding factors . Compliers with a subsequent clinical trial decreased their risk of becoming cases and , if ill at trial entry , increased their case remission rate . Conclusions The ascription of an ‘ above average risk ’ label for coronary disease to middle-aged men does not adversely affect the psychological state of those who receive it if they have received preparation for risk labelling . However , communicating abnormal coronary disease test results without adequate preparation confers short-term psychological harm . Non-specific support from familiar general practice professionals received by participants in a clinical trial reduces the risk of psychological ill-health . All coronary disease screening programmes should include adequate pre-labelling preparation for all risk labels and abnormal results",
"BACKGROUND Evidence of the value of systematic ally collecting family history in primary care is limited . OBJECTIVE To evaluate the feasibility of systematic ally collecting family history of coronary heart disease in primary care and the effect of incorporating these data into cardiovascular risk assessment . DESIGN Pragmatic , matched-pair , cluster r and omized , controlled trial . ( International St and ardized R and omized Controlled Trial Number Register : IS RCT N 17943542 ) . SETTING 24 family practice s in the United Kingdom . PARTICIPANTS 748 persons aged 30 to 65 years with no previously diagnosed cardiovascular risk , seen between July 2007 and March 2009 . INTERVENTION Participants in control practice s had the usual Framingham-based cardiovascular risk assessment with and without use of existing family history information in their medical records . Participants in intervention practice s also completed a question naire to systematic ally collect their family history . All participants were informed of their risk status . Participants with high cardiovascular risk were invited for a consultation . MEASUREMENTS The primary outcome was the proportion of participants with high cardiovascular risk ( 10-year risk ≥ 20 % ) . Other measures included question naire completion rate and anxiety score . RESULTS 98 % of participants completed the family history question naire . The mean increase in proportion of participants classified as having high cardiovascular risk was 4.8 percentage points in the intervention practice s , compared with 0.3 percentage point in control practice s when family history from patient records was incorporated . The 4.5-percentage point difference between groups ( 95 % CI , 1.7 to 7.2 percentage points ) remained significant after adjustment for participant and practice characteristics ( P = 0.007 ) . Anxiety scores were similar between groups . LIMITATIONS Relatively few participants were from ethnic minority or less-educated groups . The potential to explore behavioral change and clinical outcomes was limited . Many data were missing for anxiety scores . CONCLUSION Systematic ally collecting family history increases the proportion of persons identified as having high cardiovascular risk for further targeted prevention and seems to have little or no effect on anxiety . PRIMARY FUNDING SOURCE Genetics Health Services Research program of the United Kingdom Department of Health",
"OBJECTIVES To compare antihypertensive therapeutic strategies and efficacy whether the physicians were aware or not of the calculated cardiovascular risk at 10 years obtained from the Framingham equation . It was also possible to evaluate the concordance of the general physicians estimation of the cardiovascular risk with the calculated percentage . METHODS The participation of 953 general physicians to the study allowed to achieve an estimation of the absolute cardiovascular risk for 1,243 hypertensives . Patients were r and omised in 2 groups according to the knowledge or not by the physicians of the calculated risk . The therapeutic strategy included a monotherapy ( Fosinopril 20 mg/days ) for a follow up of 8 weeks , with the possibility to increase the treatment after 4 weeks ( Fosinopril + hydrochlorotiazide ) . To be included , patients had to be more than 18 and less than 75 years , and a blood pressure above 140/90 mmHg . Estimated and calculated cardiovascular risk at 10 years , were classified according to the 1999 WHO-ISH guidelines : low risk 30 % . RESULTS In this population , aged 60 + /- 10 years , with 54 % of men , the concordance between estimated risk and calculated risk was of 35 % . This concordance was better for the \" low risk \" and \" very high risk \" , but remains inferior to 50 % . The determinants of concordance were : gender ( male ) , smoking and a low HDL cholesterol . After 8 weeks of treatment , no difference was observed between the 2 groups concerning final blood pressure level , percentage of normalised patients and number of patients with bi-therapy . CONCLUSIONS General physicians estimation of cardiovascular risk at 10 years of hypertensive subjects has a bad concordance with the calculated risk according to Framingham equation . The results of this study indicate that the estimation of cardiovascular risk of hypertensive subjects does not modify the management of hypertension",
"BACKGROUND Despite increasing evidence that treating dyslipidemia reduces cardiovascular events , many patients do not achieve recommended lipid targets . METHODS To determine whether showing physicians and patients the patient 's calculated coronary risk can improve the effectiveness of treating dyslipidemia in a primary care setting , patients were r and omized to receive usual care or ongoing feedback regarding their calculated coronary risk and the change in this risk after lifestyle changes , pharmacotherapy , or both to treat dyslipidemia . Outcomes , based on intention-to-treat analysis , included changes in blood lipid levels , coronary risk , and the frequency of reaching lipid targets . RESULTS Two hundred thirty primary care physicians enrolled 3,053 patients . After 12 months of follow-up , 2,687 patients ( 88.0 % ) remained in the study . After adjustment for baseline lipid values , significantly greater mean reductions in low-density lipoprotein cholesterol levels and the total cholesterol to high-density lipoprotein cholesterol ratio were observed in patients receiving risk profiles ( 51.2 mg/dL [ to convert to millimoles per liter , multiply by 0.0259 ] and 1.5 , respectively ) vs usual care ( 48.0 mg/dL and 1.3 , respectively ) , but the differences were small ( -3.3 mg/dL ; 95 % confidence interval [ CI ] , -5.4 to -1.1 mg/dL ; and -0.1 ; 95 % CI , -0.2 to -0.1 , respectively ) . Patients in the risk profile group were also more likely to reach lipid targets ( odds ratio , 1.26 ; 95 % CI , 1.07 to 1.48 ) . A significant dose-response effect was also noted when the impact of the risk profile was stronger in those with worse profiles . CONCLUSIONS Discussing coronary risk with the patient is associated with a small but measurable improvement in the efficacy of lipid therapy . The value of incorporating risk assessment in preventive care should be further evaluated",
"Abstract Objectives : To determine the effectiveness of a health check and assess any particular benefits result ing from feedback of plasma cholesterol concentration or coronary risk score , or both Design : R and omised controlled trial in two Glasgow work sites Subjects:1632 employees ( 89 % male ) aged 20 to 65 years . Interventions : At the larger work site , ( a ) health education ; ( b ) health education and feedback on cholesterol concentration ; ( c ) health education and feedback on risk score ; ( d ) health education with feedback on cholesterol concentration and risk score ( full health check ) ; ( e ) no health intervention ( internal control ) . At the other work site there was no health intervention ( external control ) . Main outcome measures Changes in Dundee risk score , plasma cholesterol concentration , diastolic blood pressure , body mass index , and self reported behaviours ( smoking , exercise , alcohol intake , and diet ) in comparison with internal and external control groups Results : Comparisons between the full health check and the internal control groups showed a small difference ( 0.13 mmol/l ) in the change in mean cholesterol concentration ( 95 % confidence interval 0.02 to 0.22 , P=0.02 ) but no significant differences for changes in Dundee risk score ( P=0.21 ) , diastolic blood pressure ( P=0.71 ) , body mass index ( P=0.16 ) , smoking ( P=1.00 ) , or exercise ( P=0.41 ) . Significant differences between the two groups were detected for changes in self reported consumption of alcohol ( 41 % in group with full health check v 17 % in internal control group , P=0.001 ) , fruit and vegetables ( 24 % v 12 % , P fat ( 30 % v 9 % , P cholesterol concentration or risk score , or both . Conclusions : The health check only had a small effect on reversible coronary risk . It was effective in influencing self reported alcohol consumption and diet . Feedback on cholesterol concentration and on risk score did not provide additional motivation for a change in behaviour",
"Using perceived risk of a heart attack , we examined the relative importance of perceived risk factors and sociodemographic variables on subjects ' perception of heart attack risk , the relationship between perceived and objective ly measured heart attack risk , and the effect of health risk appraisal ( HRA ) feedback on risk perceptions . Data derive from a r and om sample of 732 Greater Boston , Massachusetts area men and women ages 25 - 65 years , who participated in a field trial of health risk appraisal instruments . At baseline and approximately two months later , all respondents completed a question naire assessing their own health-related behavior , risk factors , and perception of heart attack risk . At baseline , respondents also completed one of four HRA instruments . Physiologic measures of cholesterol , blood pressure , and weight were taken at either baseline or follow-up visit . Results showed that respondents used established risk factors in estimating overall risk ; that compared to objective measures of risk , a high percentage of respondents displayed an optimistic bias ; and that HRA feedback had some effect on perception of heart attack risk for those at high risk . Implication s of these results for health promotion are discussed",
"BACKGROUND Exposure to combination antiretroviral therapy ( cART ) can lead to important metabolic changes and increased risk of coronary heart disease ( CHD ) . Computerized clinical decision support systems have been advocated to improve the management of patients at risk for CHD but it is unclear whether such systems reduce patients ' risk for CHD . METHODS We conducted a cluster trial within the Swiss HIV Cohort Study ( SHCS ) of HIV-infected patients , aged 18 years or older , not pregnant and receiving cART for > 3 months . We r and omized 165 physicians to either guidelines for CHD risk factor management alone or guidelines plus CHD risk profiles . Risk profiles included the Framingham risk score , CHD drug prescriptions and CHD events based on biannual assessment s , and were continuously up date d by the SHCS data centre and integrated into patient charts by study nurses . Outcome measures were total cholesterol , systolic and diastolic blood pressure and Framingham risk score . RESULTS A total of 3,266 patients ( 80 % of those eligible ) had a final assessment of the primary outcome at least 12 months after the start of the trial . Mean ( 95 % confidence interval ) patient differences where physicians received CHD risk profiles and guidelines , rather than guidelines alone , were total cholesterol -0.02 mmol/l ( -0.09 - 0.06 ) , systolic blood pressure -0.4 mmHg ( -1.6 - 0.8 ) , diastolic blood pressure -0.4 mmHg ( -1.5 - 0.7 ) and Framingham 10-year risk score -0.2 % ( -0.5 - 0.1 ) . CONCLUSIONS Systemic computerized routine provision of CHD risk profiles in addition to guidelines does not significantly improve risk factors for CHD in patients on cART",
"Background R and omised , controlled trials focusing on long-term psychological reactions to information about increased risk of coronary heart disease are scarce . Design A population -based r and omised , controlled , 5-year follow-up trial was conducted in general practice . Methods In 1991 , invitations were sent to 2,000 middle-aged people registered in the general practice s in the district of Ebeltoft , Denmark . A total of 1,507 ( 75.4 % ) agreed to participate and were r and omised into a control group and two intervention groups : one included health screening , a written feedback and an optional follow-up visit with the general practitioner ; the other included health screening , written feedback and a planned 45-min follow-up visit with the general practitioner . The participants were informed at screening about their risk of developing coronary heart disease . Psychological distress was measured by the GHQ-12 before screening and at the 1 and the 5-year follow-up . Results Before the screening ( 0 year ) , 1 and 5 years after there were no significant differences in the GHQ-12 score between the control group and the two intervention groups . Nor were there any differences related to information about increased risk of coronary heart disease between scores obtained at the 1 and the 5-year follow-up . Conclusion Middle-aged persons had no long-term psychological reaction after information about increased risk of developing coronary heart disease following a health screening in general practice evaluated by the GHQ-12,1 year and 5 years after the examinations",
"AIM Informing a person of their individual risk of developing a disease in the future may be sufficient to provide the person with the impetus to adopt risk reducing behaviours . The aim of this study was to determine if a personalised 10-year cardiovascular disease ( CVD ) risk estimate can increase physical activity and other risk reduction behaviours in adults at high risk of CVD . METHODS Pilot 2 × 2 factorial r and omised controlled trial conducted in Oxfordshire , UK including 194 adults at increased CVD risk ( 10-year CVD risk ≥ 20 % ) recruited from four general practice s. Main outcome measure at one month was physical activity measured by accelerometer . RESULTS Median ( IQR ) age was 62.3 ( 54.9 , 66.1 ) years , 67 % were men and 19 % had known diabetes . Mean ( SD ) total accelerometer counts per day was 297 × 10(-3 ) ( 110 × 10(-3 ) ) and activity of moderate or greater intensity was undertaken for 53 ( 22 ) minutes per day . In the 185 ( 95 % ) participants attending follow-up an increase in physical activity was not seen . There was a non-significant 0.5 % ( p = 0.56 ) greater increase in accelerometer counts in those receiving personalised CVD risk estimates . No significant within or between group changes were seen at one month in estimated 10-year CVD risk . A net 7 % decrease in mean LDL cholesterol ( p = 0.004 ) was seen in the intervention group despite similar increases in new prescriptions for lipid lowering therapies . CONCLUSION In adults at increased risk of CVD provision of personalised 10-year CVD risk estimates did not appear to increase physical activity or estimated CVD risk over a one-month period",
"Background — Primary prevention guidelines focus on risk , often assuming negligible aversion to medication , yet most patients discontinue primary prevention statins within 3 years . We quantify real-world distribution of medication disutility and separately calculate the average utilities for a range of risk strata . Method and Results — We r and omly sample d 360 members of the general public in London . Medication aversion was quantified as the gain in lifespan required by each individual to offset the inconvenience ( disutility ) of taking an idealized daily preventative tablet . In parallel , we constructed tables of expected gain in lifespan ( utility ) from initiating statin therapy for each age group , sex , and cardiovascular risk profile in the population . This allowed comparison of the widths of the distributions of medication disutility and of group-average expectation of longevity gain . Observed medication disutility ranged from 1 day to > 10 years of life being required by subjects ( median , 6 months ; interquartile range , 1–36 months ) to make daily preventative therapy worthwhile . Average expected longevity benefit from statins at ages ≥50 years ranges from 3.6 months ( low-risk women ) to 24.3 months ( high-risk men ) . Conclusion — We can no longer assume that medication disutility is almost zero . Over one-quarter of subjects had disutility exceeding the group-average longevity gain from statins expected even for the highest-risk ( ie , highest-gain ) group . Future primary prevention studies might explore medication disutility in larger population s. Patients may differ more in disutility than in prospect ively definable utility ( which provides only group-average estimates ) . Consultations could be enriched by assessing disutility and exploring its reasons"
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BACKGROUND People with stroke or transient ischaemic attack ( TIA ) are at increased risk of future stroke and other cardiovascular events . Evidence -based strategies for secondary stroke prevention have been established . However , the implementation of prevention strategies could be improved . OBJECTIVES To assess the effects of stroke service interventions for implementing secondary stroke prevention strategies on modifiable risk factor control , including patient adherence to prescribed medications , and the occurrence of secondary cardiovascular events . SEARCH METHODS We search ed the Cochrane Stroke Group Trials Register ( April 2013 ) , the Cochrane Effective Practice and Organisation of Care Group Trials Register ( April 2013 ) , CENTRAL ( The Cochrane Library 2013 , issue 3 ) , MEDLINE ( 1950 to April 2013 ) , EMBASE ( 1981 to April 2013 ) and 10 additional data bases . We located further studies by search ing reference lists of articles and contacting authors of included studies . SELECTION CRITERIA We included r and omised controlled trials ( RCTs ) that evaluated the effects of organisational or educational and behavioural interventions ( compared with usual care ) on modifiable risk factor control for secondary stroke prevention . DATA COLLECTION AND ANALYSIS Two review authors selected studies for inclusion and independently extracted data . One review author assessed the risk of bias for the included studies . We sought missing data from trialists . MAIN RESULTS This review included 26 studies involving 8021 participants . Overall the studies were of reasonable quality , but one study was considered at high risk of bias . Fifteen studies evaluated predominantly organisational interventions and 11 studies evaluated educational and behavioural interventions for patients . Results were pooled where appropriate , although some clinical and method ological heterogeneity was present . The estimated effects of organisational interventions were compatible with improvements and no differences in the modifiable risk factors mean systolic blood pressure ( mean difference ( MD ) -2.57 mmHg ; 95 % confidence interval ( CI ) -5.46 to 0.31 ) , mean diastolic blood pressure ( MD -0.90 mmHg ; 95 % CI -2.49 to 0.68 ) , blood pressure target achievement ( OR 1.24 ; 95 % CI 0.94 to 1.64 ) and mean body mass index ( MD -0.68 kg/m(2 ) ; 95 % CI -1.46 to 0.11 ) . There were no significant effects of organisational interventions on lipid profile , HbA1c , medication adherence or recurrent cardiovascular events . Educational and behavioural interventions were not generally associated with clear differences in any of the review outcomes , with only two exceptions . AUTHORS ' CONCLUSIONS Pooled results indicated that educational interventions were not associated with clear differences in any of the review outcomes . The estimated effects of organisational interventions were compatible with improvements and no differences in several modifiable risk factors . We identified a large number of ongoing studies , suggesting that research in this area is increasing . The use of st and ardised outcome measures would facilitate the synthesis of future research findings
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"INTRODUCTION A high level of physical activity is associated with a decreased risk of first stroke and physical activity modifies recognized stroke risk factors and is recommended for stroke survivors . Available research shows that stroke patients can increase their level of physical performance over a short period . When the intervention period is over , physical performance often declines towards baseline level . Currently , there is no evidence on the association between physical activity and the risk of recurrent stroke . The ExStroke Pilot Trial is a r and omized clinical trial with the aim of increasing stroke patients ' level of physical activity and secondarily to associate the level of physical activity to the risk of recurrent stroke , myocardial infa rct ion , and all-cause mortality in the two groups . We describe the rationale , design , and baseline data of the ExStroke Pilot Trial . METHODS Patients with ischemic stroke above 39 years were r and omized to intervention or control group . The intervention group will , over a 2-year period , receive information on and verbal instruction to exercise by a physiotherapist or a physician . The control group will receive the department 's usual care . Physical activity is assessed in both groups seven times during follow-up using the Physical Activity Scale for the Elderly ( PASE ) question naire , which quantifies the amount of physical activity done in the last seven days prior to interview . The PASE score constitutes the primary outcome measure . The secondary outcome is the time from r and omization to recurrent stroke , myocardial infa rct ion , or all-cause mortality . Further outcome measures include : time from r and omization to recurrent stroke , myocardial infa rct ion , and vascular death ; recurrent stroke ; modified Rankin Scale ; quality of life ; occurrence of falls and fractures . TRIAL STATUS From 9 centers in 4 countries , 314 patients were included and follow-up is ongoing . Mean age and st and ard deviation ( SD ) of the study participants was 68.4 ( 11.9 ) years and 56.4 % were male . Mean ( SD ) PASE score was 84.1 ( 55.9 ) and median ( interquartile range ) Sc and inavian Stroke Scale score was 54 ( 51 - 58 )",
"Background and Purpose — High rates of ischemic stroke and poor adherence to secondary prevention measures are observed in the Chinese population . Methods — We used a national , multicenter , cluster-r and omized controlled trial in which 47 hospitals were r and omized to either a structured care program group ( n=23 ) or a usual care group ( n=24 ) . The structured care program consisted of a specialist-administered , guideline -recommended pharmaceutical treatment and a lifestyle modification algorithm associated with written and Internet-accessed educational material for patients for the secondary prevention of ischemic stroke . The primary efficacy outcome was the proportion of patients who adhered to the recommended measures at 12-month postdischarge . This trial is registered with Clinical Trial.gov ( NCT00664846 ) . Results — At 12 months , 1287 ( 72.1 % ) patients in the St and ard Medical Management in Secondary Prevention of Ischemic Stroke in China ( SMART ) group and 1430 ( 72 % ) patients in the usual care group had completed the 12-month follow-up ( P=0.342 ) . Compared with the usual care group , those in the SMART group showed higher adherence to statins ( 56 % versus 33 % ; P=0.006 ) but no difference in adherence to antiplatelet ( 81 % versus 75 % ; P=0.088 ) , antihypertensive ( 67 % versus 69 % ; P=0.661 ) , or diabetes mellitus drugs ( 73 % versus 67 % ; P=0.297 ) . No significant difference in the composite end point ( new-onset ischemic stroke , hemorrhagic stroke , acute coronary syndrome , and all-cause death ) was observed ( 3.56 % versus 3.59 % ; P=0.921 ) . Conclusions — The implementation of a program to improve adherence to secondary ischemic stroke prevention efforts in China is feasible , but these programs had only a limited impact on adherence and no impact on 1-year outcomes . Further development of a structured program to reduce vascular events after stroke is needed . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00664846",
"Background Over 65 % of stroke survivors are either overweight or obese and have multiple cardiovascular risk factors . However , few studies have examined the effects of comprehensive lifestyle behavior interventions to promote weight loss and control cardiovascular risk factors in stroke survivors . Thus , the purpose of this study is to examine a novel behavior change approach - SystemCHANGE ™ - to promote weight loss and improve health and function in stroke survivors . SystemCHANGE ™ focuses on re design ing the social environment to achieve a specific goal . Methods We will conduct a r and omized controlled pilot study to examine the efficacy , feasibility , and safety of the SystemCHANGE ™ weight management program in overweight and obese stroke survivors . The central hypothesis of the study is that the SystemCHANGE ™ intervention will help overweight and obese stroke survivors lose 5 % of their body weight , thereby improving health and function . Thirty-five stroke survivors will be r and omized into either the 6-month SystemCHANGE ™ intervention or a contact-control intervention . Outcome measures will be assessed at baseline and again at 3 and 6 months after the interventions . Body composition will be assessed using a Bod Pod . Patient-reported outcomes will be the Stroke Impact Scale and Reintegration to Normal Living Index . Objective outcomes will include the 6-Minute Walking Test and Rivermead Motor Assessment . Discussion This study will be the first r and omized controlled trial to evaluate the efficacy and safety of a weight management intervention in stroke survivors using the SystemCHANGE ™ approach . Furthermore , it will be the first empirically-examined comprehensive lifestyle intervention design ed to target physical activity , nutrition , and sleep to promote weight loss in stroke survivors . Trial registration Clinical Trials.gov Identifier :",
"Objective : Despite evidence demonstrating that risk-factor management is effective in reducing recurrent cerebrovascular disease , there are very few structured care programmes for stroke survivors . The aim was to implement and evaluate an integrated care programme in stroke . Methods : 186 patients with stroke were r and omised to either the treatment ( integrated care ) or control ( usual care ) group and were followed up over 12 months . The Integrated Care for the Reduction of Secondary Stroke ( ICARUSS ) model of integrated care involved collaboration between a specialist stroke service , a hospital coordinator and a patient ’s general practitioner . The primary aim was to promote the management of vascular risk factors through ongoing patient contact and education . Results : In the 12 months poststroke , systolic blood pressure ( sBP ) decreased in the treatment group but increased in controls . The group difference was significant , and remained so when age , sex , disability and sBP at discharge were accounted for ( p = 0.04 ) . Treatment patients also exhibited better modification of body mass index ( p = 0.007 ) and number of walks taken ( p controls . Rankin scores indicated significantly reduced disability in treatment patients relative to controls in the year poststroke ( p = 0.003 ) . Conclusions : Through an integrated system of education , advice and support to both patient and GP , the ICARUSS model was effective in modifying a variety of vascular risk factors and therefore should decrease the likelihood or recurrent stroke or vascular event",
"Background Case management has emerged as a promising alternative approach to supplement traditional one-on-one sessions between patients and doctors for improving the quality of care in chronic diseases such as coronary heart disease ( CHD ) . However , data are lacking in terms of its efficacy and cost-effectiveness when implemented in ethnic and low-income population s. Methods The Stanford and San Mateo Heart to Heart ( HTH ) project is a r and omized controlled clinical trial design ed to rigorously evaluate the efficacy and cost-effectiveness of a multi-risk cardiovascular case management program in low-income , primarily ethnic minority patients served by a local county health care system in California . R and omization occurred at the patient level . The primary outcome measure is the absolute CHD risk over 10 years . Secondary outcome measures include adherence to guidelines on CHD prevention practice . We documented the study design , methodology , and baseline sociodemographic , clinical and lifestyle characteristics of 419 participants . Results We achieved equal distributions of the sociodemographic , biophysical and lifestyle characteristics between the two r and omization groups . HTH participants had a mean age of 56 years , 63 % were Latinos/Hispanics , 65 % female , 61 % less educated , and 62 % were not employed . Twenty percent of participants reported having a prior cardiovascular event . 10-year CHD risk averaged 18 % in men and 13 % in women despite a modest low-density lipoprotein cholesterol level and a high on-treatment percentage at baseline . Sixty-three percent of participants were diagnosed with diabetes and an additional 22 % had metabolic syndrome . In addition , many participants had depressed high-density lipoprotein ( HDL ) cholesterol levels and elevated values of total cholesterol-to-HDL ratio , triglycerides , triglyceride-to-HDL ratio , and blood pressure . Furthermore , nearly 70 % of participants were obese , 45 % had a family history of CHD or stroke , and 16 % were current smokers . Conclusion We have recruited an ethnically diverse , low-income cohort in which to implement a case management approach and test its efficacy and cost-effectiveness . HTH will advance the scientific underst and ing of better strategies for CHD prevention among these priority sub population s and aid in guiding future practice that will reduce health disparities",
"Objective To investigate whether an internet based , nurse led vascular risk factor management programme promoting self management on top of usual care is more effective than usual care alone in reducing vascular risk factors in patients with clinical ly manifest vascular disease . Design Prospect i ve r and omised controlled trial . Setting Multicentre trial in secondary and tertiary healthcare setting . Participants 330 patients with a recent clinical manifestation of atherosclerosis in the coronary , cerebral , or peripheral arteries and with at least two treatable risk factors not at goal . Intervention Personalised website with an overview and actual status of patients ’ risk factors and mail communication via the website with a nurse practitioner for 12 months ; the intervention combined self management support , monitoring of disease control , and drug treatment . Main outcome measures The primary endpoint was the relative change in Framingham heart risk score after 1 year . Secondary endpoints were absolute changes in the levels of risk factors and the differences between groups in the change in proportion of patients reaching treatment goals for each risk factor . Results Participants ’ mean age was 59.9 ( SD 8.4 ) years , and most patients ( n=246 ; 75 % ) were male . After 1 year , the relative change in Framingham heart risk score of the intervention group compared with the usual care group was −14 % ( 95 % confidence interval −25 % to −2 % ) . At baseline , the Framingham heart risk score was higher in the intervention group than in the usual care group ( 16.1 ( SD 10.6 ) v 14.0 ( 10.5 ) ) , so the outcome was adjusted for the separate variables of the Framingham heart risk score and for the baseline Framingham heart risk score . This produced a relative change of −12 % ( −22 % to −3 % ) in Framingham heart risk score for the intervention group compared with the usual care group adjusted for the separate variables of the score and −8 % ( −18 % to 2 % ) adjusted for the baseline score . Of the individual risk factors , a difference between groups was observed in low density lipoprotein cholesterol ( −0.3 , −0.5 to −0.1 , mmol/L ) and smoking ( −7.7 % , −14.9 % to −0.4 % ) . Some other risk factors tended to improve ( body mass index , triglycerides , systolic blood pressure , renal function ) or tended to worsen ( glucose concentration , albuminuria ) . Conclusion An internet based , nurse led treatment programme on top of usual care for vascular risk factors had a small effect on lowering vascular risk and on lowering of some vascular risk factors in patients with vascular disease . Trial registration Clinical trials NCT00785031",
"Objectives To investigate if repeated verbal instructions about physical activity to patients with ischaemic stroke could increase long term physical activity . Design Multicentre , multinational , r and omised clinical trial with masked outcome assessment . Setting Stroke units in Denmark , China , Pol and , and Estonia . Participants 314 patients with ischaemic stroke aged ≥40 years who were able to walk—157 ( mean age 69.7 years ) r and omised to the intervention , 157 ( mean age 69.4 years ) in the control group . Interventions Patients r and omised to the intervention were instructed in a detailed training programme before discharge and at five follow-up visits during 24 months . Control patients had follow-up visits with the same frequency but without instructions in physical activity . Main outcome measures Physical activity assessed with the Physical Activity Scale for the Elderly ( PASE ) at each visit . Secondary outcomes were clinical events . Results The estimated mean PASE scores were 69.1 in the intervention group and 64.0 in the control group ( difference 5.0 ( 95 % confidence interval −5.8 to 15.9 ) , P=0.36 . The intervention had no significant effect on mortality , recurrent stroke , myocardial infa rct ion , or falls and fractures . Conclusion Repeated encouragement and verbal instruction in being physically active did not lead to a significant increase in physical activity measured by the PASE score . More intensive strategies seem to be needed to promote physical activity after ischaemic stroke . Trial registration Clinical Trials",
"Background Self-monitoring of hypertension with self-titration of antihypertensives ( self-management ) results in lower systolic blood pressure for at least one year . However , few people in high risk groups have been evaluated to date and previous work suggests a smaller effect size in these groups . This trial therefore aims to assess the added value of self-management in high risk groups over and above usual care . Methods / Design The targets and self-management for the control of blood pressure in stroke and at risk groups ( TASMIN-SR ) trial will be a pragmatic primary care based , unblinded , r and omised controlled trial of self-management of blood pressure ( BP ) compared to usual care . Eligible patients will have a history of stroke , coronary heart disease , diabetes or chronic kidney disease and will be recruited from primary care . Participants will be individually r and omised to either usual care or self-management . The primary outcome of the trial will be difference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP and covariates . 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of 5 mmHg with 90 % power . Secondary outcomes will include self-efficacy , lifestyle behaviours , health-related quality of life and adverse events . An economic analysis will consider both within trial costs and a model extrapolating the results thereafter . A qualitative analysis will gain insights into patients ’ views , experiences and decision making processes . Discussion The results of the trial will be directly applicable to primary care in the UK . If successful , self-management of blood pressure in people with stroke and other high risk conditions would be applicable to many hundreds of thous and s of individuals in the UK and beyond . Trial Registration IS RCT",
"Background Enhanced secondary preventive follow-up after stroke or transient ischemic attack ( TIA ) is necessary for improved adherence to recommendations regarding blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) levels . We investigated whether nurse-led , telephone-based follow-up was more efficient than usual care at improving BP and LDL-C levels at 12 months after hospital discharge . Methods We r and omized 537 patients to either nurse-led , telephone-based follow-up ( intervention ) or usual care ( control ) . BP and LDL-C measurements were performed at 1 month ( baseline ) and 12 months post-discharge . Intervention group patients who did not meet target values at baseline received additional follow-up , including titration of medication and lifestyle counselling , to reach treatment goals ( BP , LDL-C 2.5 mmol/L ) . Results At 12 months , mean systolic BP , diastolic BP and LDL-C was 3.3 ( 95 % CI 0.3 to 6.3 ) mmHg , 2.3 mmHg ( 95 % CI 0.5 to 4.2 ) and 0.3 mmol/L ( 95 % CI 0.1 to 0.4 ) lower in the intervention group compared to controls . Among participants with values above the treatment goal at baseline , the difference in systolic BP and LDL-C was more pronounced ( 8.0 mmHg , 95 % CI 4.0 to 12.1 , and 0.6 mmol/L , 95 % CI 0.4 to 0.9 ) . A larger proportion of the intervention group reached the treatment goal for systolic BP ( 68.5 vs. 56.8 % , p = 0.008 ) and LDL-C ( 69.7 % vs. 50.4 % , p Nurse-led , telephone-based secondary preventive follow-up , including medication adjustment , was significantly more efficient than usual care at improving BP and LDL-C levels by 12 months post-discharge . Trial Registration IS RCT N Registry IS RCT",
"Background Adherence to preventive medication is often poor , and current interventions have had limited success . Purpose This study was conducted to pilot a r and omised controlled trial aim ed at increasing adherence to preventive medication in stroke survivors using a brief , personalised intervention . Methods Sixty-two stroke survivors were r and omly allocated to either a two-session intervention aim ed at increasing adherence via ( a ) introducing a plan linked to environmental cues ( implementation intentions ) to help establish a better medication-taking routine ( habit ) and ( b ) eliciting and modifying any mistaken patient beliefs regarding medication/stroke or a control group . Primary outcome was adherence to antihypertensive medication measured objective ly over 3 months using an electronic pill bottle . Results Fifty-eight people used the pill bottle and were analysed as allocated ; 54 completed treatment . The intervention result ed in 10 % more doses taken on schedule ( intervention , 97 % ; control , 87 % ; 95 % CI for difference ( 0.2 , 16.2 ) ; p = 0.048 ) . Conclusions A simple , brief intervention increased medication adherence in stroke survivors , over and above any effect of increased patient contact or mere measurement . ( http://controlled-trials.com , number IS RCT N38274953 .",
"Objective The purpose of this study is to identify factors which predict adherence in stroke survivors . Design This is a longitudinal study where 180 stroke survivors were assessed 1 year after their first ischaemic stroke . The relationship between adherence and illness and medication beliefs was tested at baseline ( time 1 ) and again 5–6 weeks later ( time 2).Main Outcome Measures The main outcome measures used in this study are Medication Adherence Report Scale and urinary salicylate levels . Results Four variables predicted time 1 poor adherence : ( 1 ) younger age , ( 2 ) increased specific concerns about medications , ( 3 ) reduced cognitive functioning and ( 4 ) low perceived benefit of medication . Three out of these four variables were again predictive of time 2 adherence and accounted for 24 % of the variance : ( 1 ) younger age , ( 2 ) increased specific concerns about medications and ( 3 ) low perceived benefit of medication . The urinary salicylate assay failed to differentiate between patients taking and not taking aspirin . Conclusion Interventions to improve adherence should target patients ’ beliefs about their medication",
"The effectiveness of methods to prevent stroke recurrence and of education focusing on learners ' needs has not been fully explored . The aims of this study were to assess the effects of such interventions among stroke patients and their primary caregivers and to evaluate the feasibility of a web-based stroke education program . The participants were 36 patients with a clinical diagnosis of ischemic stroke within 12 months post-stroke and their primary caregivers . The participants were r and omly assigned to either an experimental or a control group . The primary measures included blood chemistry , self-reported health behaviors , sense of control , and health motivation for stroke patients , and caregiver mastery for caregivers . To test the feasibility of the intervention program , the rates of participation and occurrence of technical problems were calculated . The experimental group tended to improve significantly more than the control group in terms of exercise , diet , sense of control and health motivation for the stroke patients and in terms of caregiver mastery for the primary caregivers . The rate of participation in the web-based program was 63.1 % . This program , which focuses on recurrence prevention in stroke patients and caregivers , has the potential to improve health behaviors for stroke patients",
"BACKGROUND The objective of this study was to examine the association of Joint National Committee ( JNC-V ) blood pressure and National Cholesterol Education Program ( NCEP ) cholesterol categories with coronary heart disease ( CHD ) risk , to incorporate them into coronary prediction algorithms , and to compare the discrimination properties of this approach with other noncategorical prediction functions . METHODS AND RESULTS This work was design ed as a prospect i ve , single-center study in the setting of a community-based cohort . The patients were 2489 men and 2856 women 30 to 74 years old at baseline with 12 years of follow-up . During the 12 years of follow-up , a total of 383 men and 227 women developed CHD , which was significantly associated with categories of blood pressure , total cholesterol , LDL cholesterol , and HDL cholesterol ( all P accuracy of this categorical approach was found to be comparable to CHD prediction when the continuous variables themselves were used . After adjustment for other factors , approximately 28 % of CHD events in men and 29 % in women were attributable to blood pressure levels that exceeded high normal ( > or = 130/85 ) . The corresponding multivariable-adjusted attributable risk percent associated with elevated total cholesterol ( > or = 200 mg/dL ) was 27 % in men and 34 % in women . CONCLUSIONS Recommended guidelines of blood pressure , total cholesterol , and LDL cholesterol effectively predict CHD risk in a middle-aged white population sample . A simple coronary disease prediction algorithm was developed using categorical variables , which allows physicians to predict multivariate CHD risk in patients without overt CHD",
"Background More than 60 % of new strokes each year are \" mild \" in severity and this proportion is expected to rise in the years to come . Within our current health care system those with \" mild \" stroke are typically discharged home within days , without further referral to health or rehabilitation services other than advice to see their family physician . Those with mild stroke often have limited access to support from health professionals with stroke-specific knowledge who would typically provide critical information on topics such as secondary stroke prevention , community reintegration , medication counselling and problem solving with regard to specific concerns that arise . Isolation and lack of knowledge may lead to a worsening of health problems including stroke recurrence and unnecessary and costly health care utilization . The purpose of this study is to assess the effectiveness , for individuals who experience a first \" mild \" stroke , of a sustainable , low cost , multimodal support intervention ( comprising information , education and telephone support ) - \" WE CALL \" compared to a passive intervention ( providing the name and phone number of a re source person available if they feel the need to ) - \" YOU CALL \" , on two primary outcomes : unplanned-use of health services for negative events and quality of life . Method / Design We will recruit 384 adults who meet inclusion criteria for a first mild stroke across six Canadian sites . Baseline measures will be taken within the first month after stroke onset . Participants will be stratified according to comorbidity level and r and omised to one of two groups : YOU CALL or WE CALL . Both interventions will be offered over a six months period . Primary outcomes include unplanned use of heath services for negative event ( frequency calendar ) and quality of life ( EQ-5D and Quality of Life Index ) . Secondary outcomes include participation level ( LIFE-H ) , depression ( Beck Depression Inventory II ) and use of health services for health promotion or prevention ( frequency calendar ) . Blind assessors will gather data at mid-intervention , end of intervention and one year follow up . Discussion If effective , this multimodal intervention could be delivered in both urban and rural environments . For example , existing infrastructure such as regional stroke centers and existing secondary stroke prevention clinics , make this intervention , if effective , deliverable and sustainable . Trial Registration IS RCT",
"OBJECTIVE Given the large number of patients at high risk of vascular events , new strategies are needed to reduce vascular risk . We investigated whether self-efficacy promotion could change self-efficacy levels in patients with vascular diseases and whether baseline self-efficacy and changes in self-efficacy were related to changes in vascular risk factors . METHODS One hundred fifty-three recently referred patients with symptomatic vascular diseases ( cerebrovascular , abdominal , or peripheral arterial ) participated in a r and omized trial investigating the effect of nursing care , as compared with usual care , on vascular risk factors . Nursing care consisted of self-efficacy promotion and medical treatment of vascular risk factors . Self-efficacy and vascular risk factors ( smoking , BMI , waist , blood pressure , lipid , and glucose levels ) were measured at baseline and after 1 year . RESULTS While total self-efficacy did not change over the 1-year intervention period in either treatment group , self-efficacy in choosing healthy food ( mean + 0.4+/-1.4 , p-value 0.01 ) and in doing extra exercise ( mean + 0.3+/-1.3 , p-value 0.03 ) increased in the intervention group . No relation was seen between baseline total self-efficacy or change in composite self-efficacy and change in vascular risk factors . CONCLUSION The nursing intervention did not influence total self-efficacy but did improve self-efficacy in choosing healthy food and doing extra exercise . Change in composite self-efficacy was not related to change in vascular risk factors in patients at high risk of developing ( new ) cardiovascular diseases . PRACTICE IMPLICATION S Influencing self-efficacy in choosing healthy food and doing extra exercise could be incorporated in vascular risk reduction programs in addition to medical treatment of vascular risk factors",
"Abstract Background High blood pressure in patients with stroke increases the risk of recurrence but management in the community is often inadequate . Home blood pressure monitoring may increase patients ' involvement in their care , increase compliance , and reduce the need for patients to attend their General Practitioner if blood pressure is adequately controlled . However the value of home monitoring to improve blood pressure control is unclear . In particular its use has not been evaluated in stroke patients in whom neurological and cognitive ability may present unique challenges . Design Community based r and omised trial with follow up after 12 months . Participants : 360 patients admitted to three South London Stroke units with stroke or transient ischaemic attack within the past 9 months will be recruited from the wards or out patients and r and omly allocated into two groups . All patients will be visited by the specialist nurse at home at baseline when she will measure their blood pressure and administer a question naire . These procedures will be repeated at 12 months follow up by another research er blind as to whether the patient is in intervention or control group . Intervention : Intervention patients will be given a vali date d home blood pressure monitor and support from the specialist nurse . Control patients will continue with usual care ( blood pressure monitoring by their practice ) . Main outcome measures in both groups after 12 months : 1 . Change in systolic blood pressure.2 . Cost effectiveness : Incremental cost of the intervention to the National Health Service and incremental cost per quality adjusted life year gained . Trial registration Clinical Trials.gov registration",
"Background and Purpose — Stroke prevention clinics ( SPCs ) are not usually involved with the active management of hypertension , hyperlipidemia , diabetes , and smoking . The effect of consultations generated at SPCs on the adequacy of the management of these risk factors for stroke has not been well described , and few studies have long-term follow-up . Methods — We performed a prospect i ve study of 119 consecutive patients referred to an SPC for secondary prevention . One year after their baseline visit , patients were re-evaluated for the adequacy of the management of the above risk factors , and the proportion of improvement was assessed . Results — One-hundred twelve patients returned for their 1-year follow-up visit . Sixty-six were male , and the average age was 65 years . Hypertension was present in 83 patients , hyperlipidemia in 92 , diabetes in 26 , and smoking in 38 , and 80 had multiple risk factors . At baseline , 66 % of patients with hypertension , 17 % of patients with hyperlipidemia , and 23 % of diabetics had adequate management of their respective risk factors . During 1 year of follow-up , hypertension management improved 20 % ( P lipid management improved 32 % ( P improvement in diabetes management or smoking cessation . Conclusions — Although our underst and ing of the benefit of addressing hypertension , hyperlipidemia , diabetes , and smoking for secondary prevention of stroke is evolving , we found marked room for improvement in the management of these four risk factors . SPCs may need to be more actively involved in the management of these modifiable risk factors , if we are to significantly impact the risk of recurrent stroke",
"Objective Tailoring stroke information and providing reinforcement opportunities are two strategies proposed to enhance the effectiveness of education . This study aim ed to evaluate the effects of an education package which utilised both strategies on the knowledge , health and psychosocial outcomes of stroke patients and carers . Design Multisite , r and omised trial comparing usual care with an education and support package . Setting Two acute stroke units . Participants Patients and their carers ( N=138 ) were r and omised ( control n=67 , intervention n=71 ) of which data for 119 participants ( control n=59 , intervention n=60 ) were analysed . Intervention The package consisted of a computer-generated , tailored written information booklet and verbal reinforcement provided prior to , and for 3 months following , discharge . Outcome measures Outcome measures were administered prior to hospital discharge and at 3-month follow-up by blinded assessors . The primary outcome was stroke knowledge ( score range : 0–25 ) . Secondary outcomes were : self-efficacy ( 1–10 ) , anxiety and depression ( 0–21 ) , ratings of importance of information ( 1–10 ) , feelings of being informed ( 1–10 ) , satisfaction with information ( 1–10 ) , caregiver burden ( carers ) ( 0–13 ) and quality of life ( patients ) ( 1–5 ) . Results Intervention group participants reported better : self-efficacy for accessing stroke information ( adjusted mean difference ( MD ) of 1.0 , 95 % CI 0.3 to 1.7 , p=0.004 ) ; feeling informed ( MD 0.9 , 95 % CI 0.2 to 1.6 , p=0.008 ) ; and satisfaction with medical ( MD 2.0 , 95 % CI 1.1 to 2.8 , p practical ( MD 1.1 , 95 % CI 0.3 to 1.9 , p=0.008 ) , services and benefits ( MD 0.9 , 95 % CI 0.1 to 1.8 , p=0.036 ) and secondary prevention information ( MD 1.7 , 95 % CI 0.9 to 2.5 , p Conclusions Intervention group participants had improved self-efficacy for accessing stroke information and satisfaction with information , but other outcomes were not significantly affected . Evaluation of a more intensive intervention in a trial with a larger sample size is required to establish the value of an educational intervention that uses tailoring and reinforcement strategies .",
"Background Survivors of transient ischemic attack ( TIA ) or stroke are at high risk for recurrent vascular events and aggressive treatment of vascular risk factors can reduce this risk . However , vascular risk factors , especially hypertension and high cholesterol , are not managed optimally even in those patients seen in specialized clinics . This gap between the evidence for secondary prevention of stroke and the clinical reality leads to suboptimal patient outcomes . In this study , we will be testing a pharmacist case manager for delivery of stroke prevention services . We hypothesize this new structure will improve processes of care which in turn should lead to improved outcomes . Methods We will conduct a prospect i ve , r and omized , controlled open-label with blinded ascertainment of outcomes ( PROBE ) trial . Treatment allocation will be concealed from the study personnel , and all outcomes will be collected in an independent and blinded manner by observers who have not been involved in the patient 's clinical care or trial participation and who are masked to baseline measurements . Patients will be r and omized to control or a pharmacist case manager treating vascular risk factors to guideline -recommended target levels . Eligible patients will include all adult patients seen at stroke prevention clinics in Edmonton , Alberta after an ischemic stroke or TIA who have uncontrolled hypertension ( defined as systolic blood pressure ( BP ) > 140 mm Hg ) or dyslipidemia ( fasting LDL-cholesterol > 2.00 mmol/L ) and who are not cognitively impaired or institutionalized . The primary outcome will be the proportion of subjects who attain ' optimal BP and lipid control'(defined as systolic BP vascular risk and health-related quality of life will also be collected . Conclusions Nearly one-quarter of those who survive a TIA or minor stroke suffer another vascular event within a year . If our intervention improves the provision of secondary prevention therapies in these patients , the clinical ( and financial ) implication s will be enormous",
"Background There is growing interest in conducting clinical and cluster r and omized trials through electronic health records . This paper reports on the method ological issues identified during the implementation of two cluster r and omized trials using the electronic health records of the Clinical Practice Research Data link ( CPRD ) . Methods Two trials were completed in primary care : one aim ed to reduce inappropriate antibiotic prescribing for acute respiratory infection ; the other aim ed to increase physician adherence with secondary prevention interventions after first stroke . The paper draws on documentary records and trial data sets to report on the method ological experience with respect to research ethics and research governance approval , general practice recruitment and allocation , sample size calculation and power , intervention implementation , and trial analysis . Results We obtained research governance approvals from more than 150 primary care organizations in Engl and , Wales , and Scotl and . There were 104 CPRD general practice s recruited to the antibiotic trial and 106 to the stroke trial , with the target number of practice s being recruited within six months . Interventions were installed into practice information systems remotely over the internet . The mean number of participants per practice was 5,588 in the antibiotic trial and 110 in the stroke trial , with the coefficient of variation of practice sizes being 0.53 and 0.56 respectively . Outcome measures showed substantial correlations between the 12 months before , and after intervention , with coefficients ranging from 0.42 for diastolic blood pressure to 0.91 for proportion of consultations with antibiotics prescribed , defining practice and participant eligibility for analysis requires careful consideration . Conclusions Cluster r and omized trials may be performed efficiently in large sample s from UK general practice s using the electronic health records of a primary care data base . The geographical dispersal of trial sites presents a difficulty for research governance approval and intervention implementation . Pretrial data analyses should inform trial design and analysis plans . Trial registration Current Controlled Trials IS RCT N47558792 and IS RCT N35701810 ( both registered on 17 March 2010 )",
"Background Black and Hispanic stroke survivors experience higher rates of recurrent stroke than whites . This disparity is partly explained by disproportionately higher rates of uncontrolled hypertension in these population s. Home blood pressure telemonitoring ( HBPTM ) and nurse case management ( NCM ) have proven efficacy in addressing the multilevel barriers to blood pressure ( BP ) control and reducing BP . However , the effectiveness of these interventions has not been evaluated in stroke patients . This study is design ed to evaluate the comparative effectiveness , cost-effectiveness and sustainability of these two telehealth interventions in reducing BP and recurrent stroke among high-risk Black and Hispanic stroke survivors with uncontrolled hypertension . Methods / Design A total of 450 Black and Hispanic patients with recent nondisabling stroke and uncontrolled hypertension are r and omly assigned to one of two 12-month interventions : 1 ) HBPTM with wireless feedback to primary care providers or 2 ) HBPTM plus individualized , culturally-tailored , telephone-based NCM . Patients are recruited from stroke centers and primary care practice s within the Health and Hospital Corporations ( HHC ) Network in New York City . Study visits occur at baseline , 6 , 12 and 24 months . The primary outcomes are within-patient change in systolic BP at 12 months , and the rate of stroke recurrence at 24 months . The secondary outcome is the comparative cost-effectiveness of the interventions at 12 and 24 months ; and exploratory outcomes include changes in stroke risk factors , health behaviors and treatment intensification . Recruitment for the stroke telemonitoring hypertension trial is currently ongoing . Discussion The combination of two established and effective interventions along with the utilization of health information technology supports the sustainability of the HBPTM + NCM intervention and feasibility of its widespread implementation . Results of this trial will provide strong empirical evidence to inform clinical guidelines for management of stroke in minority stroke survivors with uncontrolled hypertension . If effective among Black and Hispanic stroke survivors , these interventions have the potential to substantially mitigate racial and ethnic disparities in stroke recurrence . Trial registration Clinical Trials.gov NCT02011685 . Registered 10 December 2013",
"Background This study aim ed to inform the design of a pragmatic trial of stroke prevention in primary care by evaluating data recorded in electronic patient records ( EPRs ) as potential outcome measures . The study also evaluated achievement of recommended st and ards of care ; variation between family practice s ; and changes in risk factor values from before to after stroke . Methods Data from the UK General Practice Research Data base ( GPRD ) were analysed for 22,730 participants with an index first stroke between 2003 and 2006 from 414 family practice s. For each subject , the EPR was evaluated for the 12 months before and after stroke . Measures relevant to stroke secondary prevention were analysed including blood pressure ( BP ) , cholesterol , smoking , alcohol use , body mass index ( BMI ) , atrial fibrillation , utilisation of antihypertensive , antiplatelet and cholesterol lowering drugs . Intraclass correlation coefficients ( ICC ) were estimated by family practice . R and om effects models were fitted to evaluate changes in risk factor values over time . Results In the 12 months following stroke , BP was recorded for 90 % , cholesterol for 70 % and body mass index ( BMI ) for 47 % . ICCs by family practice ranged from 0.02 for BP and BMI to 0.05 for LDL and HDL cholesterol . For subjects with records available both before and after stroke , the mean reductions from before to after stroke were : mean systolic BP , 6.02 mm Hg ; diastolic BP , 2.78 mm Hg ; total cholesterol , 0.60 mmol/l ; BMI , 0.34 Kg/m2 . There was an absolute reduction in smokers of 5 % and heavy drinkers of 4 % . The proportion of stroke patients within the recommended guidelines varied from less than a third ( 29 % ) for systolic BP , just over half for BMI ( 54 % ) , and over 90 % ( 92 % ) on alcohol consumption . Conclusions Electronic patient records have potential for evaluation of outcomes in pragmatic trials of stroke secondary prevention . Stroke prevention interventions in primary care remain suboptimal but important reductions in vascular risk factor values were observed following stroke . Better recording of lifestyle factors in the GPRD has the potential to exp and the scope of the GPRD for health care research and practice",
"Rationale Recurrent stroke is prevalent in both developed and developing countries , contributing significantly to disability and death . Recurrent stroke rates can be reduced by adequate risk factor management . However , adherence to prescribed medications and lifestyle changes recommended by physicians at discharge after stroke is poor , leading to a large number of preventable recurrent strokes . Using behavior change methods such as Motivational Interviewing early after stroke occurrence has the potential to prevent recurrent stroke . Aims and /or hypothesis The overall aim of the study is to determine the effectiveness of motivational interviewing in improving adherence to medication and lifestyle changes recommended by treating physicians at and after hospital discharge in stroke patients 12 months poststroke to reduce risk factors for recurrent stroke . Design Recruitment of 430 first-ever stroke participants will occur in the Auckl and and Waikato regions . R and omization will be to intervention or usual care groups . Participants r and omized to intervention will receive four motivational interviews and five follow-up assessment s over 12 months . Nonintervention participants will be assessed at the same time points . Study outcomes Primary outcome measures are changes in systolic blood pressure and low-density lipoprotein levels 12 months poststroke . Secondary outcomes include self-reported adherence and barriers to prescribed medications , new cardiovascular events ( including stroke ) , changes in quality of life , and mood . Discussion The results of the motivational interviewing in stroke trial will add to our underst and ing of whether motivational interviewing may be potentially beneficial in the management of stroke and other diseases where similar lifestyle factors or medication adherence are relevant",
"Background Secondary prevention after stroke and transient ischemic attack ( TIA ) is essential in order to reduce morbidity and mortality . Secondary stroke prevention studies have , however , been fairly small , or performed as clinical trials with non-representative patient selection . Long-term follow-up data is also limited . A nurse-led follow-up for risk factor improvement may be effective but the evidence is limited . The aims of this study are to perform an adequately sized , nurse-led , long-term secondary preventive follow-up with a population -based inclusion of stroke and TIA patients . The focus will be on blood pressure and lipid control as well as tobacco use and physical activity . Methods A r and omized , controlled , long-term , population -based trial with two parallel groups . The patients will be included during the initial hospital stay . Important outcome variables are sitting systolic and diastolic blood pressure , LDL cholesterol and total cholesterol . Outcomes will be measured after 12 , 24 and 36 months of follow-up . Trained nurses will manage the intervention group with a focus on reaching set treatment goals as soon as possible . The control group will receive usual care . At least 200 patients will be included in each group , in order to reliably detect a difference in mean systolic blood pressure of 5 mmHg . This sample size is also adequate for detection of clinical ly meaningful group differences in the other outcomes . Discussion This study will test the hypothesis that a nurse-led , long-term follow-up after stroke with a focus on reaching set treatment goals as soon as possible , is an effective secondary preventive method . If proven effective , this method could be implemented in general practice at a low cost . Trial registration Current Controlled Trials IS RCT",
"CONTEXT Level of acuity and number of referrals for home health care have been escalating exponentially . As referrals continue to increase , health care organizations are encouraged to find more effective methods for providing high- quality patient care with cost savings . OBJECTIVE To evaluate the use of remote video technology in the home health care setting as well as the quality , use , patient satisfaction , and cost savings from this technology . DESIGN Quasi-experimental study conducted from May 1996 to October 1997 . SETTING Home health department in the Sacramento , Calif , facility of a large health maintenance organization . PARTICIPANTS Newly referred patients diagnosed as having congestive heart failure , chronic obstructive pulmonary disease , cerebral vascular accident , cancer , diabetes , anxiety , or need for wound care were eligible for r and om assignment to intervention ( n = 102 ) or control ( n = 110 ) groups . INTERVENTION The control and intervention groups received routine home health care ( home visits and telephone contact ) . The intervention group also had access to a remote video system that allowed nurses and patients to interact in real time . The video system included peripheral equipment for assessing cardiopulmonary status . MAIN OUTCOME MEASURES Three quality indicators ( medication compliance , knowledge of disease , and ability for self-care ) ; extent of use of services ; degree of patient satisfaction as reported on a 3-part scale ; and direct and indirect costs of using the remote video technology . RESULTS No differences in the quality indicators , patient satisfaction , or use were seen . Although the average direct cost for home health services was $ 1830 in the intervention group and $ 1167 in the control group , the total mean costs of care , excluding home health care costs , were $ 1948 in the intervention group and $ 2674 in the control group . CONCLUSIONS Remote video technology in the home health care setting was shown to be effective , well received by patients , capable of maintaining quality of care , and to have the potential for cost savings . Patients seemed pleased with the equipment and the ability to access a home health care provider 24 hours a day . Remote technology has the potential to effect cost savings when used to substitute some in-person visits and can also improve access to home health care staff for patients and caregivers . This technology can thus be an asset for patients and providers",
"BACKGROUND Comprehensive and long-term patient education programs design ed to improve self-management can help patients better manage their medical condition . Using disease management programs ( DMPs ) that were created for each of the risk factor according to clinical practice guidelines , we evaluate their influence on the prevention of stroke recurrence . METHODS This is a r and omized study conducted with ischemic stroke patients within 1 year from their onset . Subjects in the intervention group received a 6-month DMPs that included self-management education provided by a nurse along with support in collaboration with the primary care physician . Those in the usual care group received ordinary outpatient care . The primary end point is a difference of the Framingham risk score-general cardiovascular disease 10-year risk [ corrected ] . Patients were enrolled for 2 years with plans for a 2-year follow-up after the 6-month education period ( total of 30 months ) . RESULTS A total of 321 eligible subjects ( average age , 67.3 years ; females , 96 [ 29.9 % ] ) , including 21 subjects ( 6.5 % ) with transient ischemic attack , were enrolled in this study . Regarding risk factors for stroke , 260 subjects ( 81.0 % ) had hypertension , 249 subjects ( 77.6 % ) had dyslipidemia , 102 subjects ( 31.8 % ) had diabetes mellitus , 47 subjects ( 14.6 % ) had atrial fibrillation , and 98 subjects ( 30.5 % ) had chronic kidney disease . There were no significant differences between the 2 groups with respect to subject characteristics . CONCLUSIONS This article describes the rationale , design , and baseline features of a r and omized controlled trial that aim ed to assess the effects of DMPs for the secondary prevention of stroke . Subject follow-up is in progress and will end in 2015",
"Background The purpose of this research is to develop and evaluate methods for conducting pragmatic cluster r and omized trials in a primary care electronic data base . The proposal describes one application , in a less frequent chronic condition of public health importance , secondary prevention of stroke . A related protocol in antibiotic prescribing was reported previously . Methods / Design The study aims to implement a cluster r and omized trial ( CRT ) using the electronic patient records of the General Practice Research Data base ( GPRD ) as a sampling frame and data source . The specific objective of the trial is to evaluate the effectiveness of a computer-delivered intervention at enhancing the delivery of stroke secondary prevention in primary care . GPRD family practice s will be allocated to the intervention or usual care . The intervention promotes the use of electronic prompts to support adherence with the recommendations of the UK Intercollegiate Stroke Working Party and NICE guidelines for the secondary prevention of stroke in primary care . Primary outcome measure will be the difference in systolic blood pressure between intervention and control trial arms at 12-month follow-up . Secondary outcomes will be differences in serum cholesterol , prescribing of antihypertensive drugs , statins , and antiplatelet therapy . The intervention will continue for 12 months . Information on the utilization of the decision-support tools will also be analyzed . Discussion The CRT will investigate the effectiveness of using a computer-delivered intervention to reduce the risk of stroke recurrence following a first stroke event . The study will provide method ological guidance on the implementation of CRTs in electronic data bases in primary care . Trial registration Current Controlled Trials IS RCT",
"Background There is a need to find innovative approaches for translating best practice s for chronic disease care into daily primary care practice routines . Primary care plays a crucial role in the prevention and management of cardiovascular disease . There is , however , a substantive care gap , and many challenges exist in implementing evidence -based care . The Improved Delivery of Cardiovascular Care ( IDOCC ) project is a pragmatic trial design ed to improve the delivery of evidence -based care for the prevention and management of cardiovascular disease in primary care practice s using practice outreach facilitation . Methods The IDOCC project is a stepped-wedge cluster r and omized control trial in which Practice Outreach Facilitators work with primary care practice s to improve cardiovascular disease prevention and management for patients at highest risk . Primary care practice s in a large health region in Eastern Ontario , Canada , were eligible to participate . The intervention consists of regular monthly meetings with the Practice Outreach Facilitator over a one- to two-year period . Starting with audit and feedback , consensus building , and goal setting , the practice s are supported in changing practice behavior by incorporating chronic care model elements . These elements include ( a ) evidence -based decision support for providers , ( b ) delivery system re design for practice s , ( c ) enhanced self-management support tools provided to practice s to help them engage patients , and ( d ) increased community re source linkages for practice s to enhance referral of patients . The primary outcome is a composite score measured at the level of the patient to represent each practice 's adherence to evidence -based guidelines for cardiovascular care . Qualitative analysis of the Practice Outreach Facilitators ' written narratives of their ongoing practice interactions will be done . These textual analyses will add further insight into underst and ing critical factors impacting project implementation . Discussion This pragmatic , stepped-wedge r and omized controlled trial with both quantitative and process evaluations demonstrates innovative methods of implementing large-scale quality improvement and evidence -based approaches to care delivery . This is the first Canadian study to examine the impact of a large-scale multifaceted cardiovascular quality -improvement program in primary care . It is anticipated that through the evaluation of IDOCC , we will demonstrate an effective , practical , and sustainable means of improving the cardiovascular health of patients across Canada . Trial Registration Clinical Trials.gov :",
"Background and Purpose — Efforts to reduce disparities in recurrent stroke among Black and Latino stroke survivors have met with limited success . We aim ed to determine the effect of peer education on secondary stroke prevention among predominantly minority stroke survivors . Methods — Between 2009 and 2012 , we enrolled 600 stroke or transient ischemic attack survivors from diverse , low-income communities in New York City into a 2-arm r and omized clinical trial that compared a 6 week ( 1 session/week ) , peer-led , community-based , stroke prevention self-management group workshop ( N=301 ) to a wait-list control group ( N=299 ) . The primary outcome was the proportion with a composite of controlled blood pressure ( 140/90 mm Hg ) , low-density lipoprotein cholesterol 100 mg/dL , and use of antithrombotic medications at 6 months . Secondary outcomes included control of the individual stroke risk factors . All analyses were by intent-to-treat . Results — There was no difference in the proportion of intervention and control group participants achieving the composite outcome ( 34 % versus 34 % ; P=0.98 ) . The proportion with controlled blood pressure at 6 months was greater in the intervention group than in the control group ( 76 % versus 67 % ; P=0.02 ) . This corresponded to a greater change in systolic blood pressure in the intervention versus control group ( −3.63 SD , 19.81 mm Hg versus + 0.34 SD , 23.76 mm Hg ; P=0.04 ) . There were no group differences in the control of cholesterol or use of antithrombotics . Conclusions — A low-cost peer education self-management workshop modestly improved blood pressure , but not low-density lipoprotein cholesterol or antithrombotic use , among stroke and transient ischemic attack survivors from vulnerable , predominantly minority urban communities . Clinical Trial Registration — URL : http://www . clinical trials.gov/show/NCT0102727 . Unique identifier : NCT01027273",
"Background Patients with manifest vascular disease are at high risk of a new vascular event or death . Modification of classical risk factors is often not successful . We determined whether the extra care of a nurse practitioner could be beneficial to the cardiovascular risk profile of high-risk patients . Design We conducted a r and omized , controlled trial based on the Zelen design . Methods Two hundred and thirty-six patients with manifestations of a vascular disease and who had two or more modifiable vascular risk factors were pre-r and omized to receive treatment by a nurse practitioner plus usual care or usual care alone . After 1 year , risk factors were remeasured . The primary endpoint was achievement of treatment goals for blood pressure , lipid , glucose and homocysteine levels , body mass index , and smoking . Results Of the pre-r and omized patients , 95 of 119 ( 80 % ) in the intervention group and 80 of 117 ( 68 % ) in the control group participated in the study . After a mean follow-up of 14 months , the patients in the intervention group achieved significantly more treatment goals than did the patients in the control group ( systolic blood pressure 63 versus 37 % , total cholesterol 79 versus 61 % , low density lipoprotein-cholesterol 88 versus 67 % , and body mass index 38 versus 24 % ) . Medication use was increased in both groups and no differences were found in patients ' quality of life ( SF-36 ) at follow-up . Conclusion Treatment delivered by nurse practitioners , in addition to a vascular risk factor screening and prevention program , result ed in a better management of vascular risk factors than usual care alone in vascular patients after 1-year follow-up",
"Background — Stroke is the leading cause of adult disability . Inpatient programs optimize secondary stroke prevention care at the time of hospital discharge , but such care may not be continued after hospital discharge . Methods — To improve the delivery of secondary stroke preventive services after hospital discharge , we have design ed a chronic care model – based program called SUSTAIN ( Systemic Use of STroke Averting INterventions ) . This care intervention includes group clinics , self-management support , report cards , decision support through care guides and protocol s , and coordination of ongoing care . The first specific aim is to test , in a r and omized , controlled trial , whether SUSTAIN improves blood pressure control among an analytic sample of 268 patients with a recent stroke or transient ischemic attack discharged from 4 Los Angeles County public hospitals . Secondary outcomes consist of control of other stroke risk factors , lifestyle habits , medication adherence , patient perceptions of care quality , functional status , and quality of life . A second specific aim is to conduct a cost analysis of SUSTAIN from the perspective of the Los Angeles County Department of Health Services by using direct costs of the intervention , cost equivalents of associated utilization of county system re sources , and cost equivalents of the observed and predicted averted vascular events . Conclusions — If SUSTAIN is effective , we will have the expertise and findings to advocate for its continued support at Los Angeles County hospitals and to disseminate the SUSTAIN program to other setting s serving indigent , minority population s. Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00861081",
"Objective : To test if TIA/stroke electronic decision support in primary care improves management . Methods : Multicenter , single-blind , parallel-group , cluster r and omized , controlled trial comparing TIA/stroke electronic decision support guided management with usual care . Main outcomes were guideline adherence and 90-day stroke risk . Secondary outcomes were cerebrovascular/vascular/death/adverse events , cost , and user feedback . Main analysis was logistic regression with a normal r and om effect for clusters using a generalized linear mixed model . Results : Twenty-nine clinics were r and omized to intervention , 27 to control , recruiting 172 and 119 eligible patients . More intervention patients received guideline -adherent care ( 131/172 ; 76.2 % ) than control patients ( 49/119 ; 41.2 % ) ( adjusted odds ratio [ OR ] 4.57 ; 95 % confidence interval [ CI ] 2.39–8.71 ; p Ninety-day stroke occurred in 2/172 ( 1.2 % ) intervention and 5/119 ( 4.2 % ) control patients ( OR 0.27 ; 95 % CI 0.05–1.41 ; p = 0.098 ) . Ninety-day TIA or stroke occurrence was lower in the intervention group , 4/172 ( 2.3 % ) compared to 10/119 ( 8.5 % ) control ( adjusted OR 0.26 ; 95 % CI 0.70–0.97 ; p = 0.045 ) . Fewer vascular events/deaths occurred in intervention , 6/172 ( 3.5 % ) , than in control patients , 14/119 ( 11.9 % ) ( adjusted OR 0.27 ; 95 % CI 0.09–0.78 ; p = 0.016 ) . Treatment cost ratio of 0.65 ( 95 % CI 0.47–0.91 ; p = 0.013 ) favored the intervention without increased adverse events . Clinician feedback was positive . Conclusion : Primary care use of the TIA/stroke electronic decision support tool improves guideline adherence , safely reduces treatment cost , achieves positive user feedback , and may reduce cerebrovascular and vascular event risk following TIA/stroke . Classification of evidence : This study provides Class II evidence that a primary care electronic decision support tool improves guideline adherence and might reduce 90-day stroke risk ",
"Background and Purpose — Numerous effective strategies for the secondary prevention of cardiovascular events in high-risk patients have now been established . We sought to calculate the cumulative benefit of combining multiple strategies for preventing recurrent events in patients with a history of ischemic stroke or transient ischemic attack . Methods — A comprehensive literature search was undertaken to identify meta-analyses of r and omized controlled trials reporting on the efficacy of secondary prevention strategies . The baseline incidence of vascular events was modeled from the Life Long After Cerebral Ischemia study . Strategies were combined on a multiplicative scale and cumulative risk reductions were computed over a 5-year interval . Results — The combination of 5 proven strategies applied to survivors of an initial stroke or transient ischemic attack — dietary modification , exercise , aspirin , a statin , and an antihypertensive agent — could result in a cumulative relative risk reduction of 80 % . Given a 5-year major cardiovascular event rate of 24 % , this translates to a number needed to treat of about 5 . Further gains would result from applying multimodality therapy over longer intervals and enriching the base strategy with dual antiplatelet therapy , high-dose statins , and more intensive blood pressure – lowering . Even more benefit would be present in high-risk subgroups with the addition , where appropriate , of carotid endarterectomy , moderate intensity oral anticoagulants , glycemic control , and smoking cessation . Conclusions — At least four-fifths of recurrent vascular events in patients with cerebrovascular disease might be prevented by application of a comprehensive , multifactorial approach",
"BACKGROUND Current guidelines recommend global risk assessment to guide vascular risk factor management ; however , most provider-patient communication focuses on individual risk factors in isolation . We sought to evaluate the impact of personalized coronary heart disease and stroke risk communication on patients ' knowledge , beliefs , and health behavior . METHODS We conducted a r and omized controlled trial testing personalized risk communication based on Framingham stroke and coronary heart disease risk scores compared with a st and ard risk factor education . A total of 89 patients were recruited from primary care clinics and followed up for 3 months . Outcomes included the following : risk perception and worry , risk factor knowledge , risk reduction preferences and decision conflict , medication adherence , health behaviors , and blood pressure . RESULTS Participants had a very low underst and ing of numeric information , high perceived risk for stroke or myocardial infa rct ion , and high proportion of medication nonadherence . Patients ' ability to identify vascular risk factors increased with personalized risk communication ( mean 1.8 additional risk factors , 95 % CI 1.3 - 2.2 ) and st and ard risk factor education ( mean 1.6 additional risk factors , 95 % CI 1.1 - 2.1 ) immediately after the intervention but was not sustained at 3 months . Patients in the personalized group had less decision conflict than the st and ard risk factor education group over intended risk reduction strategies ( 5.9 vs 10.1 , P = .003 ) . There was no appreciable impact of either communication strategy on medication adherence , exercise , smoking cessation , or blood pressure . CONCLUSIONS Personalized risk communication was preferred by patients and had a small impact on risk reduction preferences and decision conflict but had no impact on patient beliefs or behavior compared with st and ard risk factor education",
"AIMS The effectiveness of multifactorial cardiovascular disease prevention in patients aged 75 years or older is uncertain , because these patients have often been excluded from trials . The aim of this pre-planned , first-year analysis of the Drugs and Evidence -Based Medicine in the Elderly ( DEBATE ) Study was to determine the feasibility of prevention efforts in elderly cardiovascular patients . METHODS AND RESULTS For DEBATE , home-dwelling individuals aged 75 years and over with cardiovascular diseases ( n=400 , mean age 80 years , 65 % women ) were recruited from the community . These high-risk participants were r and omly assigned to the intervention group ( n=199 ) where both lifestyle modification and pharmacological cardiovascular treatments are individualized by a geriatrician according to current European guidelines . The control group ( n=201 ) receives the usual care . Interim analysis of the study groups at one year shows that intervention has succeeded in increasing the use of statins , aspirin , beta-blockers , and ACE inhibitors , and decreasing serum cholesterol ( p LDL-cholesterol ( p hsCRP ( p=0.04 ) . Body mass index , blood pressure , and blood glucose were similar at one year in both groups . No safety problems or adverse effects on health-related quality of life were observed and compliance was good . CONCLUSIONS It is possible and safe to institute evidence -based cardiovascular treatments in the 75 + cardiovascular patients in a real life setting , but only serum cholesterol and hsCRP are significantly decreased",
"Background Strokes are a common cause of adult disability and mortality worldwide . Transient ischaemic attacks ( TIA ) are associated with a high risk of subsequent stroke , and rapid intervention has the potential to reduce stroke burden . This study will assess a novel electronic decision support ( EDS ) tool to allow general practitioners ( GPs ) to implement evidence -based care rapidly without full reliance on specialists . Methods / design This is a cluster r and omized controlled trial comparing TIA/stroke management of GPs with access to the EDS tool versus usual care . The intervention period is 12 months with a 3-month follow-up period for individual patients . Primary outcomes consist of stroke within 90 days of presenting event and adherence to the New Zeal and national TIA guideline . Discussion A positive study will provide strong evidence for widespread implementation of this tool in practice and has the potential to improve key outcomes for patients and reduce the burden of stroke . Trial registration Australia New Zeal and Clinical Trials Registry",
"Abstract Background The effectiveness of medication is influenced by treatment adherence . After TIA or minor disabling stroke patients usually are advised to take antithrombotic medication . Stroke patients are an interesting group of patients with respect to adherence , since cardiovascular risk factors and stroke may ( indirectly ) negatively influence brain function , which can affect adherence . We investigated determinants of non – adherence in patients who used aspirin or oral anticoagulation after cerebral ischaemia of arterial origin . Methods Data of patients prospect ively followed in two clinical trials ( the Dutch TIA Trial and the Stroke Prevention In Reversible Ischaemia Trial ) were analysed with Cox proportional hazards modelling . Results In the two trials 3796 patients were treated with aspirin . During a mean follow – up of 2.1 years , 689 patients ( 18 % ) prematurely stopped treatment , 305 ( 8 % ) did so without a clear medical reason ( non – adherence ) . Age ≥ 65 years and the use of 300 instead of 30 mg of aspirin were independently associated with non – adherence . Diastolic blood pressure of ≥ 90 mmHg and dizziness were associated with better adherence . Of 651 patients on oral anticoagulation , 143 patients ( 22 % ) stopped after a mean follow – up of 1.0 year , 66 ( 10 % ) did so because of nonadherence . No statistically significant determinants for non – adherence were identified . Conclusion As found in the literature on nonadherence in general , age of ≥ 65 years and a higher dose of aspirin ( 300 mg versus 30 mg ) were independently associated with non – adherence with aspirin treatment that was prescribed for secondary prevention after cerebral ischaemia of arterial origin . Older patients may require extra encouragement to continue antithrombotic treatment . Lower doses of aspirin may improve treatment adherence",
"BACKGROUND The highest risk for stroke is among survivors of strokes or transient ischemic attacks ( TIA ) . However , use of proven-effective cardiovascular medications to control stroke risk is suboptimal , particularly among the Black and Latino population s disproportionately impacted by stroke . METHODS A partnership of Harlem and Bronx community representatives , stroke survivors , research ers , clinicians , outreach workers and patient educators used community-based participatory research to conceive and develop the Prevent Recurrence of All Inner-city Strokes through Education ( PRAISE ) trial . Using data from focus groups with stroke survivors , they tailored a peer-led , community-based chronic disease self-management program to address stroke risk factors . PRAISE will test , in a r and omized controlled trial , whether this stroke education intervention improves blood pressure control and a composite outcome of blood pressure control , lipid control , and use of antithrombotic medications . RESULTS Of the 582 survivors of stroke and TIA enrolled thus far , 81 % are Black or Latino and 56 % have an annual income less than $ 15,000 . Many ( 33 % ) do not have blood pressures in the target range , and most ( 66 % ) do not have control of all three major stroke risk factors . CONCLUSIONS Rates of stroke recurrence risk factors remain suboptimal in the high risk , urban , predominantly minority communities studied . With a community-partnered approach , PRAISE has recruited a large number of stroke and TIA survivors to date , and may prove successful in engaging those at highest risk for stroke and reducing disparities in stroke outcomes in inner-city communities",
"Background Effective methods of secondary prevention after stroke or TIA are available but adherence to recommended evidence -based treatments is often poor . The study aim ed to determine the quality of secondary prevention in usual care and to develop a stepwise modeled support program . Methods Two consecutive cohorts of patients with acute minor stroke or TIA undergoing usual outpatient care versus a secondary prevention program were compared . Risk factor control and medication adherence were assessed in 6-month follow-ups ( 6M-FU ) . Usual care consisted of detailed information concerning vascular risk factor targets given at discharge and regular outpatient care by primary care physicians . The stepwise modeled support program additionally employed up to four outpatient appointments . A combination of educational and behavioral strategies was employed . Results 168 patients in the observational cohort who stated their openness to participate in a prevention program ( mean age 64.7 y , admission blood pressure ( BP ) : 155/84 mmHg ) and 173 patients participating in the support program ( mean age 67.6 y , BP : 161/84 mmHg ) were assessed at 6 months . Proportions of patients with BP according to guidelines were 50 % in usual-care and 77 % in the support program ( p LDL mg/dl was measured in 62 versus 71 % ( p = 0.12 ) . Proportions of patients who stopped smoking were 50 versus 79 % ( p patients with atrial fibrillation were on oral anticoagulation ( p = 0.09 ) . Conclusions Risk factor control remains unsatisfactory in usual care . Targets of secondary prevention were met more often within the supported cohort . Effects on (cerebro-)vascular recurrence rates are going to be assessed in a multicenter r and omized trial",
"Background and Purpose — The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practice s improves risk factor control after first stroke . This study also aim ed to develop methods to implement cluster r and omized trials in stroke using electronic health records . Methods — Family practice s were recruited from the UK Clinical Practice Research Data link and allocated to intervention and control trial arms by minimization . Remotely installed , electronic decision support tools promoted intensified secondary prevention for 12 months with last measure of systolic blood pressure as the primary outcome . Outcome data from electronic health records were analyzed using marginal models . Results — There were 106 Clinical Practice Research Data link family practice s allocated ( intervention , 53 ; control , 53 ) , with 11 391 ( control , 5516 ; intervention , 5875 ) participants with acute stroke ever diagnosed . Participants at trial practice s had similar characteristics as 47 887 patients with stroke at nontrial practice s. During the intervention period , blood pressure values were recorded in the electronic health records for 90 % and cholesterol values for 84 % of participants . After intervention , the latest mean systolic blood pressure was 131.7 ( SD , 16.8 ) mm Hg in the control trial arm and 131.4 ( 16.7 ) mm Hg in the intervention trial arm , and adjusted mean difference was −0.56 mm Hg ( 95 % confidence interval , −1.38 to 0.26 ; P=0.183 ) . The financial cost of the trial was approximately US $ 22 per participant , or US $ 2400 per family practice allocated . Conclusions — Large pragmatic intervention studies may be implemented at low cost by using electronic health records . The intervention used in this trial was not found to be effective , and further research is needed to develop more effective intervention strategies . Clinical Trial Registration — URL : http://www.controlled-trials.com . Current Controlled Trials identifier : IS RCT N35701810",
"Background and Purpose : Adherence to medication is often suboptimal after stroke and transient ischemic attack ( TIA ) , which increases the risk of recurrent stroke and death . Complex interventions and motivational interviewing ( MI ) have been proven effective in other areas of medicine . The objective of this study was to investigate the effectiveness of a multifaceted intervention including MI in improving medication adherence for secondary stroke prevention . Methods : In this r and omized controlled trial , TIA and stroke patients receiving a pharmacist intervention in a hospital setting were compared with patients receiving usual care . The intervention consisted of a focused medication review , an MI-approached consultation and 3 follow-up telephone calls and lasted for 6 months . The primary outcome was a composite medication possession ratio ( MPR ) for antiplatelets , anticoagulants and statins in the year after hospitalization , assessed by analyzing pharmacy records and reported as both a continuous rate and a binary outcome . Secondary outcomes included composite MPRs at 3 , 6 and 9 months as well as adherence and persistence to specific thrombopreventive medications at 12 months . Clinical outcomes included a combined end point of cardiovascular death , stroke or acute myocardial infa rct ion . Patient satisfaction with the service was assessed for the intervention patients . Results : The analyses included 102 intervention patients and 101 controls . At 12 months , the median MPRs ( IQR ) were 0.95 ( 0.77 - 1 ) in the intervention group and 0.91 ( 0.83 - 0.99 ) in the control group , and 28 and 21 % of the patients , respectively , were nonadherent ( MPR median MPR decreased over time . From 3 to 12 months , the MPR fell by 5 % ( p adherence and persistence to specific thrombopreventive agents or for the clinical outcome . The intervention patients were satisfied with the service ; about half of them reported increased knowledge about medication , and one third reported increased confidence with medication use . Pharmacists identified drug-related problems in one third of the patients . Conclusions : A multifaceted pharmacist intervention including MI did not improve adherence or persistence to secondary stroke prevention therapy and had no impact on clinical outcomes . However , due to the high adherence rates , only little room for improvement existed . Future studies should focus on patients at high risk of nonadherence and include outcomes more sensitive to the impact of behavioral interventions",
"Background and Purpose — Many stroke patients and informal carers experience a decreased quality of life after discharge home and are dissatisfied with the care received . We assessed the effectiveness of an outreach nursing care program . Methods — In a multicenter trial , 536 stroke patients were r and omized at discharge to st and ard care ( n=273 ) or st and ard care plus outreach care ( n=263 ) . The outreach care consisted of 3 telephone calls and 1 home visit within 5 months after discharge by 1 of 13 stroke nurses . Patients were masked for the trial objectives . Six months after discharge , they assessed the 2 primary outcomes : quality of life ( Short Form 36 [ SF-36 ] ) and dissatisfaction with care . Secondary measures of outcome were disability , h and icap , depression , anxiety , and use of health care services and secondary prevention drugs . Informal carers assessed strain , and social support . Analysis was by intention to treat . Results — Twelve patients died before follow-up , 38 declined outcome assessment , and 486 completed the primary outcome assessment s. Outreach care patients had better scores on the SF-36 domain “ Role Emotional ” than controls ( mean difference 7.9 [ 95 % confidence limit , 0.1 to 15.7 ] ) . No statistically significant differences were found on the other primary outcome measures . For secondary outcomes , no statistically significant differences were found , except that intervention patients used fewer rehabilitation services ( relative risk , 0.66 [ 0.44 to 1.00 ] ) and had lower anxiety scores ( median difference 1 [ 0.19 to 2.79 ] ) . Conclusions — This outreach nursing stroke care was not effective in improving quality of life and dissatisfaction with care of recently discharged patients",
"Background Racial and ethnic disparities persist in stroke occurrence , recurrence , morbidity and mortality . Uncontrolled hypertension ( HTN ) is the most important modifiable risk factor for stroke risk . Home health care organizations care for many patients with uncontrolled HTN and history of stroke ; however , recurrent stroke prevention has not been a home care priority . We are conducting a r and omized controlled trial ( RCT ) to compare the effectiveness , relative to usual home care ( UHC ) , of two Community Transitions Interventions ( CTIs ) . The CTIs aim to reduce recurrent stroke risk among post-stroke patients via home-based transitional care focused on better HTN management . Methods / Design This 3-arm trial will r and omly assign 495 black and Hispanic post-stroke home care patients with uncontrolled systolic blood pressure ( SBP ) to one of three arms : UHC , UHC complemented by nurse practitioner-delivered transitional care ( UHC + NP ) or UHC complemented by an NP plus health coach ( UHC + NP + HC ) . Both intervention arms emphasize : 1 ) linking patients to continuous , responsive preventive and primary care , 2 ) increasing patients ’ /caregivers ’ ability to manage a culturally and individually tailored BP reduction plan , and 3 ) facilitating the patient ’s reintegration into the community after home health care discharge . The primary hypothesis is that both NP-only and NP + HC transitional care will be more effective than UHC alone in achieving a SBP reduction . The primary outcome is change in SPB at 3 and 12 months . The study also will examine cost-effectiveness , quality of life and moderators ( for example , race/ethnicity ) and mediators ( for example , changes in health behaviors ) that may affect treatment outcomes . All outcome data are collected by staff blinded to group assignment . Discussion This study targets care gaps affecting a particularly vulnerable black/Hispanic population characterized by persistent stroke disparities . It focuses on care transitions , a juncture when patients are particularly susceptible to adverse events . The CTI is innovative in adapting for stroke patients an established transitional care model shown to be effective for HF patients , pairing the professional NP with a HC , implementing a culturally tailored intervention , and placing primary emphasis on longer-term risk factor reduction and community reintegration rather than shorter-term transitional care outcomes .Trial registration Clinical Trials.gov NCT01918891 ; Registered 5 August 2013",
"Background Blood pressure ( BP ) lowering in people who have had a stroke or transient ischaemic attack ( TIA ) leads to reduced risk of further stroke . However , it is not clear what the target BP should be , since intensification of therapy may lead to additional adverse effects . PAST BP will determine whether more intensive BP targets can be achieved in a primary care setting , and whether more intensive therapy is associated with adverse effects on quality of life . Methods / Design This is a r and omised controlled trial ( RCT ) in patients with a past history of stroke or TIA . Patients will be r and omised to two groups and will either have their blood pressure ( BP ) lowered intensively to a target of 130 mmHg systolic , ( or by 10 mmHg if the baseline systolic pressure is between 125 and 140 mmHg ) compared to a st and ard group where the BP will be reduced to a target of 140 mmHg systolic . Patients will be managed by their practice at 1 - 3 month intervals depending on level of BP and followed-up by the research team at six monthly intervals for 12 months.610 patients will be recruited from approximately 50 general practice s. The following exclusion criteria will be applied : systolic BP , 3 or more anti-hypertensive agents , orthostatic hypotension , diabetes mellitus with microalbuminuria or other condition requiring a lower treatment target or terminal illness . The primary outcome will be change in systolic BP over twelve months . Secondary outcomes include quality of life , adverse events and cardiovascular events . In-depth interviews with 30 patients and 20 health care practitioners will be undertaken to investigate patient and healthcare professionals underst and ing and views of BP management . Discussion The results of this trial will inform whether intensive blood pressure targets can be achieved in people who have had a stroke or TIA in primary care , and help determine whether or not further research is required before recommending such targets for this population .Trial Registration IS RCT",
"BACKGROUND hypertension is a common risk factor for stroke/transient ischaemic attack ( TIA ) and there is good evidence that blood pressure ( BP ) control prevents recurrent stroke . We investigated whether telephone follow-up ( TFU ) improved risk factor management in hypertensive patients after stroke/TIA . METHODS we conducted a r and omised controlled trial and assigned hypertensive patients within 1 month of stroke or TIA to receive usual care ( n = 27 ) or usual care plus regular TFU ( n = 29 ) . Primary outcome was the difference in 12 h ambulatory systolic BP change from baseline to 6 months ( DeltaSBP ) in both groups . TFU at 7 days , 1 , 2 and 4 months included patient-focussed education and goal setting . RESULTS mean baseline BP was 145/83 mm Hg ( st and ard deviation ( SD ) 21/14 ) . There was no significant difference in DeltaSBP over 6 months with TFU . Median DeltaSBP was 0 mm Hg ( interquartile range 19.5 ) in the TFU group and 3.0 mm Hg ( 20 ) fall in the usual care group ( P = 0.29 ) . Post hoc analysis showed that statin use increased from baseline to 6 months ( P = 0.02 ) and cholesterol was significantly lower at 6 months in all patients ( mean reduction 0.95 mmol/l ; P BP control over 6-month follow-up in primary care after stroke/TIA",
"Background : Optimization of systolic blood pressure and lipid levels are essential for secondary prevention after ischemic stroke , but there are substantial gaps in care , which could be addressed by nurse- or pharmacist-led care . We compared 2 types of case management ( active prescribing by pharmacists or nurse-led screening and feedback to primary care physicians ) in addition to usual care . Methods : We performed a prospect i ve r and omized controlled trial involving adults with recent minor ischemic stroke or transient ischemic attack whose systolic blood pressure or lipid levels were above guideline targets . Participants in both groups had a monthly visit for 6 months with either a nurse or pharmacist . Nurses measured cardiovascular risk factors , counselled patients and faxed results to primary care physicians ( active control ) . Pharmacists did all of the above as well as prescribed according to treatment algorithms ( intervention ) . Results : Most of the 279 study participants ( mean age 67.6 yr , mean systolic blood pressure 134 mm Hg , mean low-density lipoprotein [ LDL ] cholesterol 3.23 mmol/L ) were already receiving treatment at baseline ( antihypertensives : 78.1 % ; statins : 84.6 % ) , but none met guideline targets ( systolic blood pressure ≤ 140 mm Hg , fasting LDL cholesterol ≤ 2.0 mmol/L ) . Substantial improvements were observed in both groups after 6 months : 43.4 % of participants in the pharmacist case manager group met both systolic blood pressure and LDL guideline targets compared with 30.9 % in the nurse-led group ( 12.5 % absolute difference ; number needed to treat = 8 , p = 0.03 ) . Interpretation : Compared with nurse-led case management ( risk factor evaluation , counselling and feedback to primary care providers ) , active case management by pharmacists substantially improved risk factor control at 6 months among patients who had experienced a stroke . Trial registration : Clinical Trials.gov , no.",
"Background Good blood pressure ( BP ) control reduces the risk of recurrence of stroke/transient ischaemic attack ( TIA ) . Although there is strong evidence that BP telemonitoring helps achieve good control , none of the major trials have considered the effectiveness in stroke/TIA survivors . We therefore conducted a feasibility study for a trial of BP telemonitoring for stroke/TIA survivors with uncontrolled BP in primary care . Method Phase 1 was a pilot trial involving 55 patients stratified by stroke/TIA r and omised 3:1 to BP telemonitoring for 6 months or usual care . Phase 2 was a qualitative evaluation and comprised semi-structured interviews with 16 trial participants who received telemonitoring and 3 focus groups with 23 members of stroke support groups and 7 carers . Results Overall , 125 patients ( 60 stroke patients , 65 TIA patients ) were approached and 55 ( 44 % ) patients were r and omised including 27 stroke patients and 28 TIA patients . Fifty-two participants ( 95 % ) attended the 6-month follow-up appointment , but one declined the second daytime ambulatory blood pressure monitoring ( ABPM ) measurement result ing in a 93 % completion rate for ABPM − the proposed primary outcome measure for a full trial . Adherence to telemonitoring was good ; of the 40 participants who were telemonitoring , 38 continued to provide readings throughout the 6 months . There was a mean reduction of 10.1 mmHg in systolic ABPM in the telemonitoring group compared with 3.8 mmHg in the control group , which suggested the potential for a substantial effect from telemonitoring . Our qualitative analysis found that many stroke patients were concerned about their BP and telemonitoring increased their engagement , was easy , convenient and reassuring . Conclusions A full-scale trial is feasible , likely to recruit well and have good rates of compliance and follow-up . Trial Registration IS RCT N61528726 15/12/2011",
"This study examined the baseline characteristics , racial/ethnic differences , and geographic differences among participants in the Secondary Prevention of Small Subcortical Strokes ( SPS3 ) study . The SPS3 trial enrolled patients who experienced a symptomatic small subcortical stroke ( lacunar stroke ) within the previous 6 months and an eligible lesion on detected on magnetic resonance imaging . The patients were r and omized , in a factorial design , to antiplatelet therapy ( aspirin 325 mg daily plus clopidogrel 75 mg daily vs aspirin 325 mg daily plus placebo ) and to one of two levels of systolic blood pressure targets ( \" intensive \" [ A total of 3020 participants were recruited from 81 clinical sites in 8 countries . In this cohort , the mean age was 63 years , 63 % were men , 75 % had a history of hypertension , and 37 % had diabetes . The racial distribution was 51 % white , 30 % Hispanic , and 16 % black . Compared with white subjects , black subjects were younger ( mean age , 58 years vs 64 years ; P hypertension ( 87 % vs 70 % ; P prevalence of diabetes was higher in the Hispanic and black subjects compared with the white subjects ( 42 % and 40 % vs 32 % ; both P Tobacco smoking at the time of qualifying stroke was much more frequent in the Spanish participants than in subjects from North America and from Latin America ( 32 % , 22 % , and 9 % , respectively ; P Mean systolic blood pressure at study entry was 4 mmHg lower in the Spanish subjects compared with the North American subjects ( P SPS3 cohort is the largest magnetic resonance imaging-defined series of patients with S3 . Among the racially/ethnically diverse SPS3 participants , important differences in patient features and vascular risk factors could influence prognosis for recurrent stroke and response to interventions",
"Background Patients with recent stroke or TIA are at high risk for new vascular events . Several evidence based strategies in secondary prevention of stroke are available but frequently underused . Support programs with multifactorial risk factor modifications after stroke or TIA have not been investigated in large-scale prospect i ve controlled trials so far . INSPiRE-TMS is a prospect i ve , multi-center , r and omized open intervention trial for intensified secondary prevention after minor stroke and TIA . Methods / design Patients with acute TIA or minor stroke admitted to the participating stroke centers are screened and recruited during in-hospital stay . Patients are r and omised in a 1:1 ratio to intervention ( support program ) and control ( usual care ) arms . Inclusion of 2.082 patients is planned . The support program includes cardiovascular risk factor measurement and feedback , monitoring of medication adherence , coaching in lifestyle modifications , and active involvement of relatives . St and ardized motivational interviewing is used to assess and enhance patients ’ motivation . Primary objective is a reduction of new major vascular events defined as nonfatal stroke and myocardial infa rct ion or vascular death . Recruitment time is planned for 3.5 years , follow up time is at least 2 years for every patient result ing in a total study time of 5 years ( first patient in to last patient out ) . Discussion Given the high risk for vascular re-events in acute stroke and the available effective strategies in secondary prevention , the INSPIRE-TMS support program has the potential to lead to a relevant reduction of recurrent events and a prolongation of the event-free survival time . The trial will provide the basis for the decision whether an intensified secondary prevention program after stroke should be implemented into regular care . A cost-effectiveness evaluation will be performed . Trial registration clinical trials.gov :",
"BACKGROUND AND OBJECTIVE In spite of publication of many guidelines , management of patients on secondary prevention of cardiovascular disease is still not appropriated . We design a r and omized trial , in usual clinical practice conditions , to compare the results in cardiovascular morbimortality of intensive and integral management of cardiovascular risk factors ( CVRF ) management versus conventional care . PATIENTS AND METHOD We selected patients discharged between October 2002 and January 2004 who suffered an acute coronary syndrome with or without ST-segment elevation or a stroke , 247 patients that met inclusion s criteria were r and omized to intensive care of CVRF in a specific Internal Medicine outpatient clinic ( n = 121 ) or usual care according to National Health Service recommendations ( n = 126 ) . A year after r and omization , the percentage of patients who met CVRF control , treatment received and the number of cardiovascular events ( cardiovascular death , acute coronary syndrome with or without ST-segment elevation , stroke , transient ischemic attack , revascularization , lower limb amputation , heart failure admission and sudden death ) were revised . RESULTS CVRF control was greater in patients assigned to intensive care . 74.1 % of hypertensive patients assigned to this treatment were controlled vs 41.7 % in the usual care group ( relative risk [ RR ] = 1.78 ; 95 % confidence interval [ CI ] , 1.27 - 2 - 49 ) ; 70.2 % of patients had low-densi-tiy lipoprotein cholesterol lower than 100 mg/dl vs 55.8 % ( RR = 1.26 ; 95 % CI , 1.00 - 1.58 ) of patients in usual care group ; 93.1 % of diabetic patients had glycosylated haemoglobin lower than 7 % vs. 57.1 % ( RR = 1.63 ; 95 % CI , 1.11 - 2.39 ) in the usual care group . There were 12 cardiovascular events in the intensive care group vs 35 in the usual care group . CONCLUSIONS Intensive management of CVRF leads to a better control of them and a reduction of the morbimortality one year after an acute cardiovascular event",
"IMPORTANCE Self-monitoring of blood pressure with self-titration of antihypertensives ( self-management ) results in lower blood pressure in patients with hypertension , but there are no data about patients in high-risk groups . OBJECTIVE To determine the effect of self-monitoring with self-titration of antihypertensive medication compared with usual care on systolic blood pressure among patients with cardiovascular disease , diabetes , or chronic kidney disease . DESIGN , SETTING , AND PATIENTS A primary care , unblinded , r and omized clinical trial involving 552 patients who were aged at least 35 years with a history of stroke , coronary heart disease , diabetes , or chronic kidney disease and with baseline blood pressure of at least 130/80 mm Hg being treated at 59 UK primary care practice s was conducted between March 2011 and January 2013 . INTERVENTIONS Self-monitoring of blood pressure combined with an individualized self-titration algorithm . During the study period , the office visit blood pressure measurement target was 130/80 mm Hg and the home measurement target was 120/75 mm Hg . Control patients received usual care consisting of seeing their health care clinician for routine blood pressure measurement and adjustment of medication if necessary . MAIN OUTCOMES AND MEASURES The primary outcome was the difference in systolic blood pressure between intervention and control groups at the 12-month office visit . RESULTS Primary outcome data were available from 450 patients ( 81 % ) . The mean baseline blood pressure was 143.1/80.5 mm Hg in the intervention group and 143.6/79.5 mm Hg in the control group . After 12 months , the mean blood pressure had decreased to 128.2/73.8 mm Hg in the intervention group and to 137.8/76.3 mm Hg in the control group , a difference of 9.2 mm Hg ( 95 % CI , 5.7 - 12.7 ) in systolic and 3.4 mm Hg ( 95 % CI , 1.8 - 5.0 ) in diastolic blood pressure following correction for baseline blood pressure . Multiple imputation for missing values gave similar results : the mean baseline was 143.5/80.2 mm Hg in the intervention group vs 144.2/79.9 mm Hg in the control group , and at 12 months , the mean was 128.6/73.6 mm Hg in the intervention group vs 138.2/76.4 mm Hg in the control group , with a difference of 8.8 mm Hg ( 95 % CI , 4.9 - 12.7 ) for systolic and 3.1 mm Hg ( 95 % CI , 0.7 - 5.5 ) for diastolic blood pressure between groups . These results were comparable in all subgroups , without excessive adverse events . CONCLUSIONS AND RELEVANCE Among patients with hypertension at high risk of cardiovascular disease , self-monitoring with self-titration of antihypertensive medication compared with usual care result ed in lower systolic blood pressure at 12 months . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N87171227",
"BACKGROUND Developing countries are experiencing increasing levels of cardiovascular disease ( CVD ) . Although there is a good underst and ing of how to deliver CVD prevention programs in developed countries , there are few data regarding strategies for CVD prevention in re source -poor setting s. This study aim ed to implement and evaluate a CVD prevention program in a rural area of India . METHODS The 2 strategies of CVD prevention to be investigated are an algorithm-based care approach and a health-promotion campaign . A factorial , cluster-r and omized trial design will be used to evaluate these , in which villages will be exposed to one , both , or neither of the interventions for a period of about 12 months . Surveys of households in every village will be used to assess outcomes in all high-risk individuals and a sample of the general adult population . RESULTS The primary outcome of the algorithm-based component of this study will be the percentage of high-risk individuals that have been \" identified\"-defined as having received a cardiovascular-risk assessment in the last 12 months . The primary outcome for the health-promotion component will be the percentage of the adult population with correct knowledge about the effects of 6 behavioral determinants of cardiovascular risk ( green-leafy vegetables , fruits , oily foods , salt , smoking , physical activity ) . Secondary outcomes include a range of measures defining uptake of different preventive strategies . CONCLUSIONS This study will provide evidence about the effectiveness of a simple practical mechanism of CVD preventive care specifically design ed for delivery in a re source -poor area in India",
"BACKGROUND The study examined the effects of a 12-week health promotion intervention for a predominantly urban African-American population of stroke survivors . DESIGN A pre-test/post-test lag control group design was employed . PARTICIPANTS / SETTING Participants were 35 stroke survivors ( 9 male , 26 female ) recruited from local area hospitals and clinics . MAIN OUTCOME MEASURES Biomedical , fitness , nutritional , and psychosocial measures were employed to assess program outcomes . RESULTS Treatment group made significant gains over lag controls in the following areas : ( 1 ) reduced total cholesterol , ( 2 ) reduced weight , ( 3 ) increased cardiovascular fitness , ( 4 ) increased strength , ( 5 ) increased flexibility , ( 6 ) increased life satisfaction and ability to manage self-care needs , and ( 7 ) decreased social isolation . CONCLUSION A short-term health promotion intervention for predominantly African-American stroke survivors was effective in improving several physiological and psychological health outcomes",
"The aim was to study if health outcome and secondary prevention were satisfactory 1 year after stroke and if nurse-led interventions 3 months after stroke could have impact . Design was a r and omized controlled open trial in a 1-year population . Primary outcome was health status 1 year after stroke . One month after stroke , survivors were r and omized into intervention group ( IG ) with follow-up by a specialist nurse ( SN ) after 3 months ( n = 232 ) , and control group ( CG ) with st and ard care ( n = 227 ) , all to be followed up 1 year after stroke . At the first follow-up , patients grade d their health , replied to the EuroQol-5 Dimensions ( EQ-5D ) health outcome questions , health problems were assessed , and supportive counseling was provided in the IG . Health problems requiring medical interventions were primarily referred to a general practitioner ( GP ) . One year after stroke , 391 survivors were followed up . Systolic blood pressure ( BP ) had decreased in IG ( n = 194 ) from median 140 to 135 ( P = .05 ) , but about half were above the limit 139 in both groups . A larger proportion ( 22 % ) had systolic BP > 155 in the CG ( n = 197 ) than in the IG ( 14 % ; P = .05 ) . In the IG , 62 % needed referrals compared with the 75 % in the CG ( P = .009 ) . Forty percent in the IG and 52.5 % in the CG ( P = .04 ) reported anxiety/depression . In the IG , 75 % and 67 % in the CG rated their general health as fairly good or very good ( P = .05 ) . Although nurse-led interventions could have some effect , the results were not optimal . A more powerful strategy could be closer collaboration between the SN and a stroke clinician , before referring to primary care",
"BACKGROUND Lowering blood pressure ( BP ) after stroke remains a challenge , even in the context of clinical trials . The Secondary Prevention of Small Subcortical Strokes ( SPS3 ) BP protocol , BP management during the study , and achieved BPs are described here . METHODS Patients with recent symptomatic lacunar stroke were r and omized to 1 of 2 levels of systolic BP ( SBP ) targets : lower : . SBP management over the course of the trial was examined by race/ethnicity and other baseline conditions . RESULTS Mean SBP decreased for both groups from baseline to the last follow-up , from 142.4 to 126.7 mm Hg for the lower SBP target group and from 143.6 to 137.4 mm Hg for the higher SBP target group . At baseline , participants in both groups used an average of 1.7±1.2 antihypertensive medications , which increased to a mean of 2.4±1.4 ( lower group ) and 1.8±1.4 ( higher group ) by the end- study visit . It took an average of 6 months for patients to reach their SBP target , sustained to the last follow-up . Black participants had the highest proportion of SBP ≥150 mm Hg at both study entry ( 40 % ) and end- study visit ( 17 % ) , as compared with whites ( 9 % ) and Hispanics ( 11 % ) . CONCLUSIONS These results show that it is possible to safely lower BP even to a SBP goal lowering BP and consequently reducing the burden of stroke",
"BACKGROUND AND PURPOSE There have been few community-based studies of long-term prognosis after acute stroke . This study aims to provide precise estimates of the absolute and relative risks of stroke recurrence in an unselected cohort of patients with a first-ever stroke . METHODS Six hundred seventy-five patients were registered in a community-based stroke register ( the Oxfordshire Community Stroke Project ) and prospect ively followed for up to 6.5 years . Their relative risk of recurrent stroke was calculated using age- and sex-specific incidence rates for first stroke in Oxfordshire . RESULTS One hundred eighty recurrent episodes of stroke were identified , of which 135 were first recurrences . Given survival , the actuarial risk of suffering a recurrence was 30 % ( 95 % confidence interval , 20 % to 39 % ) by 5 years , about nine times the risk of stroke in the general population . The risk was highest early after the first stroke : 13 % ( 95 % confidence interval , 10 % to 16 % ) by 1 year , 15 times the risk in the general population . After the first year the average annual risk was about 4 % . The risk of stroke recurrence did not appear to be related to age or pathological type of stroke . CONCLUSIONS The absolute and relative risks of recurrent stroke are highest early after the first stroke but remain elevated for several years thereafter . Efforts at secondary prevention should be initiated as soon as possible and continued for several years to gain greatest benefit",
"Objective : To describe the number and types of problems mentioned by successfully contacted home-dwelling stroke patients and their carers , and nursing interventions applied . Design : In this multicentre quantitative study in the Netherl and s , stroke patients and carers received outreach nurse support consisting of three telephone contacts and one home visit within six months after discharge . St and ardized checklists describing a wide range of potential problems were used to record problems and interventions . Subjects : A sample of 173 patients admitted for a stroke and discharged home , and 148 carers . Results : Of 173 patients , 166 ( 96 % ) were contacted and 162 mentioned in total 1419 problems . Physical problems were mentioned most frequently ( 92 % ; 153/166 ) , followed by emotional problems ( 60 % ; 99/166 ) . The proportion of patients with problems decreased from 94 % ( 142/151 ) at the first contact to 74 % ( 108/145 ) at the last contact . Of 148 carers , 118 ( 80 % ) were contacted and 84 mentioned 266 problems . ‘ Psychosocial burden ’ was mentioned most frequently ( 45 % ; 53/118 ) . Proportions of carers with problems were 56 % ( 54/96 ) at the first contact and 37 % ( 26/70 ) at the last contact . Of 864 interventions to patients , stroke nurses most frequently applied ‘ supportive listening ’ ( 55 % ; 471/864 ) and ‘ reassuring or encouraging ’ ( 12 % ; 107/864 ) , and of 258 interventions to carers 45 % ( 115/258 ) were ‘ supportive listening ’ and 17 % ( 43/258 ) ‘ informing ’ . Conclusions : Almost all patients and most carers were contacted . Though the number of needs decreased during the consecutive contacts , many patients and carers still raised problems during the last contact . Nurses most frequently applied the intervention ‘ supportive listening ’",
"OBJECTIVE To compare a specialized interprofessional team approach to community-based stroke rehabilitation with usual home care for stroke survivors using home care services . METHODS R and omized controlled trial of 101 community-living stroke survivors ( The intervention was a 12-month specialized , evidence -based rehabilitation strategy involving an interprofessional team . The primary outcome was change in health-related quality of life and functioning ( SF-36 ) from baseline to 12 months . Secondary outcomes were number of strokes during the 12-month follow-up , and changes in community reintegration ( RNLI ) , perceived social support ( PRQ85-Part 2 ) , anxiety and depressive symptoms ( Kessler-10 ) , cognitive function ( SPMSQ ) , and costs of use of health services from baseline to 12 months . RESULTS A total of 82 subjects completed the 12-month follow-up . Compared with the usual care group , stroke survivors in the intervention group showed clinical ly important ( although not statistically significant ) greater improvements from baseline in mean SF-36 physical functioning score ( 5.87 , 95 % CI -3.98 to 15.7 ; p=0.24 ) and social functioning score ( 9.03 , CI-7.50 to 25.6 ; p=0.28 ) . The groups did not differ for any of the secondary effectiveness outcomes . There was a higher total per-person costs of use of health services in the intervention group compared to usual home care although the difference was not statistically significant ( p=0.76 ) . CONCLUSIONS A 12-month specialized , interprofessional team is a feasible and acceptable approach to community-based stroke rehabilitation that produced greater improvements in quality of life compared to usual home care . Clinical trials.gov identifier : NCT00463229",
"Nir Z , Weisel-Eichler A : Improving knowledge and skills for use of medication by patients after stroke : Evaluation of a nursing intervention . Am J Phys Med Rehabil 2006;85:582–592 . Objective : The objective of this study was to determine if a tailored nursing intervention , as opposed to usual rehabilitation care , can improve knowledge and behavioral skills for correct use of medication use in aged stroke patients . Design : Stratified r and om sampling created two homogenous groups : 73 intervention patients , who were provided with the nursing intervention program along with usual rehabilitation care , and 82 controls , who underwent usual rehabilitation care alone . Participants were assessed within the first week of admission to the rehabilitation ward , 3 mos after stroke ( at the end of the intervention ) , and 6 mos after stroke . An assessment instrument measuring correct knowledge and skills concerning medications was used . Results : After 3 and 6 mos , intervention subjects were significantly better than controls in knowledge of shape and dosage of their medications , in knowledge of side effects and correct response to side effects , and in adherence to their dietary regimen . However , for knowledge of color and daily schedule of medications , there were differences at 3 mos , but differences were diminished after 6 mos . Conclusions : This nursing intervention , tailored to the specific needs of the aged stroke patient , increased the patients ’ knowledge and skills concerning medication therapy , but to a limited extent and for a limited time",
"Objective : Little is known about the long-term effectiveness after stroke of interventions for behaviour modification and ensuring concordance with therapies . We describe a follow-up study of a previous r and omized controlled trial of a brief period of behaviour modification . The aim of this study was to determine outcomes three years after the initial intervention . Design : Survivors of the original cohort were contacted and asked to attend for follow-up interview , within a geriatric day hospital . This study was carried out in the Geriatric Day Hospital at Stobhill Hospital , Balornock Road , Glasgow . Interventions : Details of risk factor control , including blood pressure , cholesterol levels and diabetic control , were assessed . Question naires used in the initial study were repeated including the Geriatric Depression Scale score , Euroqol Perceived Health Status and Stroke Services Satisfaction Question naire . Main measures : Primary outcome was collective risk factor control . Clinical outcomes including recurrent cerebrovascular events , medication persistence and perceived health status were also recorded . Results : Mean length of follow-up was 3.6 years ( SD 0.43 ) . Of the 205 patients enrolled in the initial study , 102 patients attended for repeat interview ( 49 intervention/53 control ) . There were no significant differences in the percentage of controlled risk factors between groups ( intervention 51.7 % versus control 55.9 % , P = 0.53 ) . Similarities were observed in the number of recurrent clinical events and medication persistence between groups . No overall difference was observed in perceived health status , satisfaction with care or depression scores . Conclusions : Brief intervention with respect to behaviour modification and risk factor control does not appear to have any long-term benefit . These results must be cautiously interpreted in light of the small study number and further research is required",
"Rationale Stroke and vascular risk factors disproportionately affect minority population s , with Blacks and Hispanics experiencing a 2.5- and 2.0-fold greater risk compared with whites , respectively . Patients with transient ischemic attacks and mild , nondisabling strokes tend to have short hospital stays , rapid discharges , and inaccurate perceptions of vascular risk . Aim The primary aim of the Discharge Educational Strategies for Reduction of Vascular Events ( DESERVE ) trial is to evaluate the efficacy of a novel community health worker-based multilevel discharge intervention vs. st and ard discharge care on vascular risk reduction among racially/ethnically diverse transient ischemic attack/mild stroke patients at one-year postdischarge . We hypothesize that those r and omized to the discharge intervention will have reduced modifiable vascular risk factors as determined by systolic blood pressure compared with those receiving usual care . Sample size estimates Given 300 subjects per group and alpha of 0.05 , the power to detect a 6 mmHg reduction in systolic blood pressure is 89 % . Design DESERVE trial is a prospect i ve , r and omized , multicenter clinical trial of a novel discharge behavioral intervention . Patients with transient ischemic attack/mild stroke are r and omized during hospitalization or emergency room visit to intervention or usual care . Intervention begins prior to discharge and continues postdischarge . Study outcomes The primary outcome is difference in systolic blood pressure reduction between groups at 12 months . Secondary outcomes include between-group differences in change in glycated hemoglobin , smoking rates , medication adherence , and recurrent stroke/transient ischemic attack at 12 months . Discussion DESERVE will evaluate whether a novel discharge education strategy leads to improved risk factor control in a racially diverse population",
"Rationale PROTECT DC examines whether stroke navigators can improve cardiovascular risk factors in urban underserved individuals newly hospitalized for stroke or ischemic attack . Within one-year of hospital discharge , up to one-third of patients no longer adhere to secondary prevention behaviors . Adherence rates are lower in minority-underserved groups , contributing to health disparities . In-hospital programs increase use of stroke prevention therapies but may not be as successful in underserved individuals . In these groups , low literacy , limited healthcare access , and sparse community re sources may reduce adherence . Lay community health workers ( navigators ) improve adherence in other illnesses through education and assisting in overcoming barriers to achieving desired health behaviors and obtaining needed healthcare services . Aims and design PROTECT DC is a Phase II , single-blind , r and omized , controlled trial comparing in-hospital education plus stroke navigators to usual care . Atherogenic ischemic stroke and transient ischemic attack survivors are recruited from Washington , DC hospitals . Navigators meet with participants during the index hospitalization , perform home visits , and meet by phone . They focus on stroke education , medication compliance , and overcoming practical barriers to adherence . The interventions are driven by the theories of reasoned action and planned behavior . Study outcomes The primary dependent measure is a summary score of four objective measures of stroke risk factor control : systolic blood pressure , low-density lipoprotein , hemoglobin Hb A1C , and antiplatelet agent pill counts . Secondary outcomes include stroke knowledge , exercise , dietary modification , and smoking cessation . Conclusion PROTECT DC will determine whether a Phase III trial of stroke navigation for urban underserved individuals to improve adherence to secondary stroke prevention behaviors is warranted",
"BACKGROUND This r and omized controlled trial tested the effectiveness of comprehensive , interdisciplinary postdischarge care management in improving a profile of indicators of health recovery and secondary prevention ( profile of health and prevention ) in stroke and transient ischemic attack ( TIA ) patients . METHODS Ninety-six stroke/TIA patients were r and omized to usual care or intervention at discharge from our acute stroke unit . The intervention group received an in-home biopsychosocial assessment by an advanced practice nurse at 1 month . A care plan was developed by an interdisciplinary team and implemented in collaboration with the patient 's primary care physician . The profile of health and prevention , measured at 3 months , was comprised of 5 domains : ( 1 ) Neuromotor Function , ( 2 ) Severe Complications , ( 3 ) Quality of Life , ( 4 ) Management of Risk for common poststroke complications and recurrent stroke , and ( 5 ) Stroke Knowledge . A single global hypothesis test across multiple end points was used to compare the 2 groups . RESULTS The intervention significantly improved the profile of health and prevention ( P Effect sizes ( in st and ard deviation units ) of the intervention on domains were .1 for Neuromotor Function ( 90 % confidence interval [ CI ] = -.3 to .5 ) ; .4 for Severe Complications ( 90 % CI = .1 to .8 ) ; .5 for Quality of Life ( 90 % CI = .1 to .9 ) ; .6 for Management of Risk for common poststroke complications and recurrent stroke ( 90 % CI = .3 to 1 . ) ; and 1.0 for Stroke Knowledge ( 90 % CI = .6 to 1.4 ) . CONCLUSIONS This model of care management result ed in a significantly better profile of health and prevention for stroke/TIA patients 3 months postdischarge",
"Background Although guidelines for secondary ischemic stroke have been developed , there is a gap between guidelines and clinic practice . Aims This study will investigate the current status of secondary ischemic stroke prevention in China , and implement a st and ard medical program in ischemic stroke and /or transient ischemic attack patients , and to examine the feasibility and efficacy of the program . Design This is a multicentre , parallel , r and omized , open label , controlled trial to evaluate the feasibility and efficacy of a recommended guideline based program ( SMART ) in secondary stroke prevention . Forty-eight sites across Mainl and China will participate in the trial . The number of enrolled patients in the study will be 4074 . Primary outcome includes the proportion of patients adherent to eligible measures recommend by the SMART program , which is derived from current prevention guidelines for ischemic stroke , and the proportion of the patients achieving the treatment target . Secondary outcomes include new onset ischemic stroke , hemorrhagic stroke , acute coronary syndrome and all causes of death . The study has been registered on Clinical trials.gov ( NCT00664846 ) ; to date , 3380 patients have been enrolled",
"Objective : To evaluate whether enhanced secondary prevention more significantly influences readiness to change health behaviour after minor stroke/transient ischaemic attack , compared with conventional stroke secondary prevention . Design : Single-blind r and omized control trial . Setting : Rural district general hospital outpatient clinic . Subjects : Fifteen women and 37 men with a mean age of 68.3 years with first minor stroke or transient ischaemic attack . Interventions : The intervention group received ‘ enhanced secondary prevention ’ ( additional advice , motivational interviewing and telephone support ) to change health behaviour . Both groups received ‘ conventional care ’ which included advice given during routine care . Main measures : The primary outcome was ‘ readiness to change behaviour ’ measured using a vali date d stroke specific score based on the transtheoretical model . Secondary outcomes were the Hospital Anxiety and Depression Scale , and self-reported alcohol consumption , smoking behaviour , exercise frequency , and fruit and vegetable consumption . Results : Analysis of the data for the 52 participants showed no statistical difference in the groups for the primary outcome of readiness to change behaviour . Statistically significant improvements for change in self-reported exercise were demonstrated ( P = 0.007 ) ; to 2—3 times per week in the intervention group compared to 0—1 times per week in the control group , and in fruit and vegetable consumption ( P = 0.033 ) ; to 10 portions of fruit and vegetables consumed per week in the intervention group compared to 1 or 2 portions a week for the control group . No evidence of a difference between groups was seen for alcohol consumption or Hospital Anxiety and Depression Scale . Conclusions : While no difference was demonstrated between the groups for readiness to change behaviour , a clinical ly significant effect in reported exercise behaviour and diet were demonstrated in the intervention group . This interesting finding indicates a dissonance between the behaviour scale and actual behaviour change , potentially indicating a lack of sensitivity of the scale to detect a change in this patient group",
"Lowering blood pressure ( BP ) in stroke survivors reduces the risk of recurrent stroke . We tested the hypothesis that a nurse-led nonpharmacologic intervention would lower the BP of participants in an intervention group compared with a control group . A total of 349 patients who had sustained acute stroke or transient ischemic attack were r and omly assigned to either usual care or to 4 home visits by a nurse . During the visits , the nurse measured and recorded BP and provided individually tailored counseling on a healthy lifestyle . A total of 303 patients completed the 1-year follow up . No change in systolic BP was noted in either the intervention group or the control group . Because of an increase in diastolic BP in the control group ( P = .03 ) , a difference in mean diastolic BP between the 2 groups was found at follow-up ( P = .007 ) . Mean BP at follow-up was 139/82 mm Hg in the intervention group and 142/86 mm Hg in the control group . Linear regression analysis demonstrated that BP at the point of discharge was the strongest predictor of BP 1 year later ( P proportion of patients on antihypertensive medication increased in the intervention group ( P = .002 ) . Patients were compliant with antihypertensive therapy , and 92 % of the hypertensive patients in the intervention group followed the advice to see a general practitioner ( GP ) for BP checkups . At follow-up , 187 patients ( 62 % ) were hypertensive , with no difference in the rate of hypertension seen between the groups . Our data indicate that home visits by nurses did not result in a lowering of BP . Patients complied with antihypertensive therapy and GP visits in the case of hypertension . Nonetheless , the majority of patients were hypertensive at the 1-year follow up",
"Background : Lifestyle modification is associated with a substantially decreased risk of cardiovascular events . However , the role of lifestyle intervention for secondary prevention in patients with noncardioembolic ischemic stroke is inadequately defined . We assessed the hypothesis that lifestyle intervention can reduce the onset of new vascular events in patients with noncardioembolic mild ischemic stroke . Methods : We conducted an observer-blind r and omized controlled trial that enrolled 70 patients ( 48 men , mean age 63.5 years ) with acute noncardioembolic mild ischemic stroke . The patients were allocated in equal numbers to a lifestyle intervention group or a control group . We performed lifestyle interventions , which comprised exercise training , salt restriction and nutrition advice for 24 weeks . Then all patients were prospect ively followed up for occurrence of the primary endpoints , including hospitalization due to stroke recurrence and the onset of other vascular events . We also evaluated systolic blood pressure ( SBP ) at the clinic and at home , low-density lipoprotein cholesterol ( LDL-C ) , high-density lipoprotein cholesterol ( HDL-C ) , hemoglobin A1c ( HbA1c ) and high-sensitivity C-reactive protein ( hs-CRP ) to compare the efficacy of the lifestyle interventions . Results : This trial was terminated earlier than expected because of the prespecified early stopping rule for efficacy . After the 24-week intervention period , the intervention group showed a significant increase in daily physical activity and a significant decrease in salt intake ( physical activity , p = 0.012 ; salt intake , p blood pressure was decreased and the HDL-C levels were increased in the intervention group ( SBP , p LDL-C , HbA1c and hs-CRP tended to decrease in the intervention group , but this decrease did not achieve significance . After a median follow-up period of 2.9 years , 12 patients allocated to the control group and 1 patient in the lifestyle intervention group experienced at least 1 vascular event . A sequential plans analysis indicated the superiority of the lifestyle intervention in interim analysis . Kaplan-Meier survival curves after the log-rank test showed a significant prognostic difference between the r and omized groups ( p = 0.005 ) . Conclusions : Lifestyle intervention with appropriate medication is beneficial for reducing the incidence of new vascular events and improving vascular risk factors in patients with noncardioembolic mild ischemic stroke",
"Background Comprehensive community care has the potential to improve risk factor management of patients with stroke or transient ischaemic attack . Aim The primary aim is to determine the effectiveness of an individualized management program on risk factor management for patients discharged from hospital after stroke . Design Multicentre , cluster-r and omized , controlled trial , with clusters by general practice . Participants are r and omized to receive intervention or control after a baseline assessment undertaken after discharge from hospital . The general practice they attend is marked as an intervention or control accordingly . All subsequent participants attending those practice s are automatically assigned as intervention or control . Baseline and all outcome assessment s , including an analysis of risk factors , are undertaken by assessors blinded to patient r and omization . Intervention Details Based on the results of blinded assessment s , the individualized management program group will receive targeted advice on how to manage their risk factors using a st and ardized , evidence -based template to communicate ‘ ideal ’ management with their general practitioner . In addition , patients r and omized to the individualized management program group will receive counselling and education about stroke risk factor management by an intervention study nurse . Individualized management programs will be review ed at three-months , six-months , 12 months , and 18 months after stroke , at which times they will be modified if appropriate . Stroke risk management will be evaluated using changes in the Framingham cardiovascular risk score . Analysis will be on an intention-to-treat basis using analysis of covariance or generalized linear model to adjust for baseline risk score and other relevant confounding factors",
"OBJECTIVE Stroke survivors are at high risk of stroke recurrence yet current strategies to reduce recurrence risk are sub-optimal . The UK Medical Research Council ( MRC ) have proposed a framework for developing and evaluating complex interventions , such as community management of stroke secondary prevention . The Framework outlines a five-phased approach from theory through to implementation of effective interventions . This paper reports Phases I-III of the development of a novel intervention to improve risk factor management after stroke . METHODS The pre- clinical /theoretical phase entailed review ing the literature and undertaking quantitative and qualitative studies to identify current practice s and barriers to secondary prevention . In Phase I ( modelling ) , findings were used to design an intervention with the potential to overcome barriers to effective stroke secondary prevention management . The feasibility of delivering the intervention and its acceptability were tested in the Phase II exploratory trial involving 25 stroke survivors and their general practitioners . RESULTS This led to the development of the definitive risk factor management intervention . This comprises multiple components and involves using an on-going population stroke register to target patients , carers and health care professionals with tailored secondary prevention advice . Clinical , socio-demographic and service use data collected by the stroke register are transformed to provide an individualised secondary prevention package for patients , carers and health care professionals at three time points : within 10 weeks , 3 and 6 months post-stroke . CONCLUSION The intervention is currently being evaluated in a r and omised controlled trial . Further research is needed to test generalisability to other aspects of stroke management and for other chronic diseases . PRACTICE IMPLICATION S The MRC Framework for complex interventions provides a structured approach to guide the development of novel interventions in public health . Implication s for practice in stroke secondary prevention will emerge when the results of our r and omised controlled trial are published",
"BACKGROUND AND PURPOSE Shared care initiatives , albeit commonly utilised in managing other chronic conditions have not been implemented in the area of stroke in Australia . The aims of this project were to adopt a shared care approach for stroke survivors comparing an experimental \" shared-care \" group with a \" treatment-as-usual \" control group in reference to the normalization or reversal of vascular risk factors and the detection and management of post-stroke depression . METHODS A r and omised controlled experimental research design was implemented with participants r and omized to an intervention or control group and followed over a 12-month period . The treatment group consisted of a r and omly selected group of patients , discharged from an acute stroke unit and transferred into the shared care model . Risk factors for stroke and depression were compared between the two groups . RESULTS Of 97 patients originally included in the study , 17 dropped out . At 12 months , 80 patients remained for analysis ( 35 in the intervention group and 45 in the control group ) . The findings demonstrated positive trends for patients within the intervention group that were not found within the control group . The percentage of intervention patients reaching target systolic blood pressure ( sBP ) of 140 mmHg after 12 months tended to be greater than in the control group ( p=0.11 , NS ) . In the intervention group , at 12 months , the total cholesterol greater than 5.18 mmol/L was 12.5 % compared to 58.8 % at discharge . In contrast this trend was not so distinct in the control group ( 57.7 % to 42.9 % ) . The percentage of patients reaching target ( recommended ) total cholesterol of 5.18 mmol/L was significantly greater in the shared care patients intervention group relative to the control group ( p=0.02 ) . The average number of walks per week was also significantly greater in intervention group compared to the control group ( p=0.048 ) . Moreover , 45 % of the control group screened as depressed compared with 20 % of the intervention group at 12 months ( p=0.06 ) . CONCLUSIONS This study demonstrates that major risk factors for recurrent stroke and vascular disease in general are better managed with the shared care model than with usual post-discharge care . The significantly reduced depression as found on the screening PHQ9 at 12 months indicated that the intervention was beneficial not only in the detection of depression but also treatment",
"ABSTRACT Secondary stroke prevention is championed as guideline care ; yet there are no systematic programs offered . We developed a stroke self-management program to address this gap and pilot test the program . We conducted a r and omized controlled trial at two Veterans Administration ( VA ) hospital sites where we recruited patients with an acute stroke to receive either the stroke program or an attention-control protocol over a 12-week period following hospital discharge . The stroke program included six sessions that facilitated stroke self management focusing on increasing self-efficacy to recover from stroke and engage in secondary stroke risk factor management . We surveyed outcomes at baseline , 3 and 6 months . We conducted an intention to treat analysis comparing the intervention to the control group on changes of outcomes between baseline and follow-up modeled by a linear model with fixed effects for treatment , visit , and the treatment by visit interaction adjusting for baseline . We recruited 63 participants ( 33 control and 30 intervention ) who were hospitalized with a primary diagnosis of ischemic stroke . We found trends in differences between groups on self-efficacy to communicate with physicians , weekly minutes spent in aerobic exercise , and on dimensions of stroke-specific quality of life . This pilot study demonstrated the feasibility of delivering a stroke self-management program to recent stroke survivors in a healthcare organization . The program also demonstrated improvements in patient self-efficacy , self-management behaviors , specific dimensions of stroke-specific quality of life compared to a group that received an attention placebo program",
"INTRODUCTION patients have reported a lack of knowledge and underst and ing of stroke and its risk factors . Uncertainty remains about the most appropriate and effective method of educating patients after stroke . OBJECTIVE to assess the impact of the CareFile , an individualized information booklet , on patients ' knowledge and satisfaction level after stroke . DESIGN r and omised pilot study for a controlled trial . SETTING a large teaching hospital in Liverpool , UK . METHODS consecutive stroke patients admitted over a 9-month period , who met the inclusion criteria and consented to participate , were r and omised into this study . All patients received the usual stroke information leaflets provided by the stroke unit . In addition , the intervention group received the ; CareFile ' , a booklet containing general information and patient-specific information on stroke . Patients in both groups completed a stroke knowledge question naire at baseline , and at three and six months post-stroke . RESULTS of the 259 admissions , 100 were eligible to participate , and 50 were r and omised to each group . There was no significant difference in patient knowledge between the groups at baseline ( P>0.05 ) . However , at three ( P knowledge of stroke . There were no differences between the groups regarding satisfaction with the information received . CONCLUSIONS a simple education package , in the form of an individualized information booklet , result ed in a significant improvement in knowledge and recognition of risk factors for stroke . The CareFile should make a valuable contribution in meeting the requirements of the National Sentinel Audit and National Service Framework regarding provision of information to patients after stroke",
"OBJECTIVE We sought to evaluate whether comprehensive postdischarge care management for stroke survivors is superior to organized acute stroke department care with enhanced discharge planning in improving a profile of health and well-being . METHODS This was a r and omized trial of a comprehensive postdischarge care management intervention for patients with ischemic stroke and National Institutes of Health Stroke Scale scores greater than or equal to 1 discharged from an acute stroke department . An advanced practice nurse performed an in-home assessment for the intervention group from which an interdisciplinary team developed patient-specific care plans . The advanced practice nurse worked with the primary care physician and patient to implement the plan during the next 6 months . The intervention and usual care groups were compared using a global and closed hypothesis testing strategy . Outcomes fell into 5 domains : ( 1 ) neuromotor function , ( 2 ) institution time or death , ( 3 ) quality of life , ( 4 ) management of risk , and ( 5 ) stroke knowledge and lifestyle . RESULTS Treatment effect was near 0 SD for all except the stroke knowledge and lifestyle domain , which showed a significant effect of the intervention ( P = .0003 ) . CONCLUSIONS Postdischarge care management was not more effective than organized stroke department care with enhanced discharge planning in most domains in this population . The intervention did , however , fill a postdischarge knowledge gap",
"We targeted stroke/transient ischemic attack ( TIA ) survivors to engage in self-management practice s to manage secondary stroke risk factors . We conducted a r and omized , regional pilot trial of a locally adapted , secondary stroke prevention program . We implemented the program at two Veterans Administration Medical Centers . Program sessions targeted stroke risk factor self-management . Specifically , we evaluated the effect of the program on the reach , implementation , and effectiveness on patient self-efficacy ; stroke-specific , health-related quality of life ; and medication adherence for the prevalent stroke risk factors : ( 1 ) diabetes , ( 2 ) hypertension , and ( 3 ) hyperlipidemia . Medication possession ratios were calculated to evaluate medication adherence using VA pharmacy benefits data pre ( 6 months prior ) and post ( 6 months after ) the stroke/TIA event . Based upon the literature st and ard of 80 % compliance rate , we dichotomized compliance and modeled the data using logistical regression . Final sample included 174 veterans with an acute stroke or TIA who were r and omized to receive either the intervention ( n = 87 ) or attention control program ( n = 87 ) . Patient self-efficacy and stroke-specific , health-related quality of life at 6 months did not significantly differ between groups . We found improvements in medication adherence within the intervention group . In the intervention group , the odds of compliance with diabetes medications post-stroke were significantly larger than the odds of compliance prior to the stroke ( odds ratio = 3.45 ( 95 % CI = 1.08–10.96 ) . For compliance to hypertension medications , the intervention group showed significantly greater odds of compliance post intervention than pre intervention ( odds ratio = 3 . 68 ( 95 % CI = 1.81–7.48 ) . The control group showed no difference in compliance rates from baseline to follow-up . For adherence to hypercholesterolemia medications , both the intervention ( odds ratio = 5.98 ( 95 % CI = 2.81–12.76 ) and control groups ( odds ratio = 3.83 ( 95 % CI = 1.83–8.01 ) , had significant increases in the odds of compliance to statin medications ; however , the comparison of changes in log odds of compliance between these two groups showed that the increases were not significantly different . We observed within group improvements in medication adherence among those receiving a post-stroke risk factor self-management program suggesting that a self-management format may be feasible to enable adherence to prescribed medications to reduce secondary stroke risk after stroke in concordance with guideline care . Additional research is needed to enhance intervention components to improve effectiveness outcomes",
"Rationale Stroke is the second-leading cause of death in low- and middle-income countries , but use of evidence -based therapies for stroke prevention in such countries , especially those in Africa , is extremely poor . This study is design ed to enhance the implementation and sustainability of secondary stroke-preventive services following hospital discharge . Aim /Hypothesis The primary study aim is to test whether a Chronic Care Model-based initiative entitled the Tailored Hospital-based Risk reduction to Impede Vascular Events after Stroke ( THRIVES ) significantly improves blood pressure control after stroke . Design This prospect i ve triple-blind r and omized controlled trial will include a cohort of 400 patients with a recent stroke discharged from four medical care facilities in Nigeria . The culturally sensitive , system-appropriate intervention comprises patient report cards , phone text messaging , an educational video , and coordination of posthospitalization care . Study Outcomes The primary outcome is improvement of blood pressure control . Secondary endpoints include control of other stroke risk factors , medication adherence , functional status , and quality of life . We will also perform a cost analysis of THRIVES from the viewpoint of government policy-makers . Discussion We anticipate that a successful intervention will serve as a scalable model of effective postdischarge chronic blood pressure management for stroke in sub-Saharan Africa and possibly for other symptomatic cardiovascular disease entities in the region",
"BACKGROUND Statins reduce the risk of vascular events , however statin prescribing is often sub optimal and better evidence is needed to inform quality improvements . The Statin Outreach Support ( SOS ) trial was design ed to test the efficacy of pharmacist led educational outreach directed at General Practice s , aim ing to improve statin prescribing for community dwelling patients with vascular disease . This paper describes the study rationale , design , methods and baseline characteristics of participants . DESIGN The SOS trial was design ed to investigate whether practice s receiving SOS improve their statin prescribing and patients achieve reduced cholesterol levels . It was a prospect i ve , single blind , cluster r and omised controlled trial with a follow-up period of 5months minimum post SOS intervention delivery . RESULTS Thirty one practice s were recruited from the UK 's largest Health Board area . At r and omisation , 16 practice s were allocated to SOS and 15 to usual care with 4040 patients included at baseline . Participating practice s showed few differences compared with non-participating practice s ; practice s and patients r and omised to each arm of the study had similar distributions with respect to age , complications , cholesterol levels and statin prescribing . Baseline data compared favourably with l and mark , placebo-controlled statin trials . CONCLUSIONS Compared with existing implementation research , SOS trial has more participants , a detailed description of baseline characteristics and over 90 % power ( at 5 % significance ) to detect a difference of 12 % in the proportion of patients with controlled cholesterol after SOS",
"Context Interventions to promote guideline -recommended care have met with limited success . Quality improvement experts believe that multicomponent interventions are more effective than simpler strategies , but this belief rests on limited evidence . Contribution In this r and omized trial of 20 primary care practice s , intervention practice s received quarterly site visits and 2 network meetings about quality improvement in addition to copies of practice guidelines and quarterly performance reports . Intervention practice s had greater improvement in providing guideline -recommended care for cardiovascular disease prevention and treatment than practice s that received only the guidelines and performance reports . Caution s The study involved a small number of practice s. The Editors Widespread evidence reveals inadequate implementation of evidence -based clinical practice guidelines for prevention and management of cardiovascular disease and stroke in primary care setting s ( 1 - 3 ) . Primary prevention deficiencies exist in the screening and management of dyslipidemia ( 4 ) and hypertension ( 5 ) . Secondary prevention deficiencies include inadequate treatment of dyslipidemia in patients with coronary heart disease ( CHD ) ( 6 ) and inadequate use of antiplatelet therapy in patients with CHD or cerebrovascular disease ( 7 ) , inadequate use of -blockers after myocardial infa rct ion ( 8) , inadequate use of angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers in patients with heart failure ( 9 ) , and inadequate use of oral anticoagulant therapy in patients with atrial fibrillation ( 10 ) . Finally , patients with diabetes mellitus who are at high risk for cardiovascular disease as well as microvascular disease infrequently receive recommended screening and adequate treatment for elevated glycosylated hemoglobin levels , hypertension , and dyslipidemia ( 11 ) . Published systematic review s point to the importance of multifaceted interventions in increasing adherence to practice guidelines and improving disease control ( 12 , 13 ) . Little is known , however , about the relative effectiveness of different implementation strategies . More research is needed to develop and vali date effective , theoretically sound , and practical strategies for improving the provision of evidence -based medicine in primary care . Particularly important are studies that address multiple common , chronic conditions , which together reflect a large proportion of the work of primary care providers ( 14 ) . This study was design ed as a pragmatic clinical trial ( 15 ) , intended to assess whether a multi method quality improvement intervention was more effective than a less intensive intervention for improving adherence to 21 quality indicators relevant to the primary and secondary prevention of cardiovascular disease and stroke . The multi method quality improvement intervention added practice site visits ( for academic detailing and quality improvement facilitation ) and network meetings ( for sharing best practice s ) to the approach of guideline dissemination and audit and feedback used in the less intensive intervention . The study was conducted in a practice -based research network ( PPRNet ) among users of a common electronic medical record ( Practice Partner Patient Records , Seattle , Washington ) , which historically provided audit and feedback to its practice members . Audit and feedback have already been shown to improve the practice of health care professionals , particularly in prescribing and test ordering ( 16 ) . Additional research is needed to assess the effect of audit and feedback in combination with other interventions . Methods Design The design was a cluster r and omized , controlled clinical trial , with the practice as the unit of r and omization . Twenty-three office-based primary care practice s in 15 states agreed to participate . The institutional review board at the Medical University of South Carolina approved the study . Study Indicators We derived the study indicators ( Table 1 ) from published sources ( 17 - 22 ) . Fourteen were process measures , which reflected whether recommended tests were done , appropriate diagnoses made , or appropriate medication prescribed . Seven were outcome measures , which reflected whether patients achieved recommended treatment goals . Some of the measures represented primary prevention , for example , screening for hypertension or dyslipidemia . Others represented secondary prevention , for example , reaching treatment goals for glycosylated hemoglobin levels , low-density lipoprotein ( LDL ) cholesterol levels , and blood pressure in patients with diabetes . An additional indicator , hormone replacement therapy for postmenopausal women , was included at the beginning of the study but was withdrawn in July 2002 when the results from the Women 's Health Initiative trial were published ( 23 ) . Table 1 . Study Indicators We determined practice performance for each study indicator at baseline and quarterly throughout the study . To determine performance , participating practice s ran a computer program to extract patient activity during the previous quarter from their electronic medical record . To protect patient confidentiality , the extract program assigned a unique , anonymous numerical identifier to each patient . The extract program obtained demographic information , such as age , race , and sex ; diagnoses ; medications ; laboratory data ; and vital signs . Text of progress notes , consultation reports , and discharge summaries were not extracted . The data were copied to a diskette and mailed to PPRNet or sent electronically via a secure server . In the PPRNet offices , the data were bridged to st and ard data dictionaries and converted to SAS data sets ( SAS Institute , Inc. , Cary , North Carolina ) on st and ard microcomputers for analyses . Interventions The intervention began on 1 January 2001 and was completed on 1 January 2003 . During the first quarter of 2001 , the medical director of each practice was sent printed copies of each practice guideline referenced in the study . Beginning in the first quarter of 2001 , the medical director was sent quarterly performance reports documenting the practice 's adherence to each of the 21 study indicators . Each report contained the practice 's current performance , calculated as the percentage of eligible patients who had received the recommended service , the number of patients who were receiving the recommended medication , or the number of patients who had achieved the treatment goal . The report also presented data on the practice s ' previous performance since the beginning of the study and the performance target , calculated as the 90th percentile at baseline among all practice s. In practice s with more than 1 clinician , individual provider data were not given because the study emphasized improvement at the practice level . The medical director was encouraged to share the reports with others in the practice in order to stimulate motivation for improvement . The 90th percentile was selected as the performance target because it reflected a bold but achievable goal ( at least 2 practice s were at this level of performance at baseline ) . Practice s in the control group received no other interventions during the study . An example of 1 page of a practice report is available in the Appendix Figure . Appendix Figure . Sample practice report for blood pressure in coronary heart disease . Practice s in the intervention group also participated in practice site visits and network meetings . Six or seven 1- or 2-day site visits were held at each practice approximately every 3 months during 2001 and 2002 . The practice site visit was led by 1 of the physician co authors , assisted during the first few visits in 2001 by a clinical pharmacist with expertise in academic detailing ( 24 ) , and at later visits by other co authors with expertise in quality improvement . Initial site visits focused on engaging clinicians and staff members in the project , through a formal presentation by the site visitors and group discussion with all members of the practice team , including providers , nurses , medical assistants , and reception and administrative personnel . Because of vacation or hospital coverage responsibilities , 1 or 2 providers were occasionally absent in the multiprovider practice s , and 1 practice involved only a few members of their staff . We placed detailed attention on the scientific justification for the chosen study indicators and on published frameworks for clinician behavior change ( 25 , 26 ) . Baseline practice performance on each study indicator was discussed , and previous evidence of the ability of PPRNet practice s to improve care was presented ( 27 ) . Practice s were encouraged to increase the use of quality improvement tools available in the electronic medical record , such as note templates with embedded practice guidelines , query functions , prompts , reminders , and messaging . At each visit , a participatory planning session was held in which practice members identified specific clinical indicators they wished to work on and improvement activities to conduct before the next site visit . Lessons from complexity theory were used in this exercisethe influence of each practice member on the system , the importance of replicating successful approaches and focusing on motivators for patients and staff , and the notion that simple changes are easiest to adopt and can have profound effects . In subsequent site visits , we focused on discussing the practice 's success in adopting its planned improvement activities , presenting up date d performance data , and planning additional practice -level interventions . The site visitors presented results from recently published studies relevant to the study indicators . Successful and unsuccessful approaches to improvement by other intervention sites were also presented . Two-day network meetings were held in Charleston , South Carolina , in May 2001 and May 2002 . The lead clinician from each intervention practice and the research team attended the first meeting . At this",
"Fundamental bias can be introduced in r and omised trials if patients can not be masked for the allocated strategy and assess subjective outcomes . In such a trial , on the effectiveness of outreach stroke care in addition to st and ard care , we masked patients by modifying the informed consent procedure . Before discharge home we informed patients that we were study ing their needs six months after discharge ; we could not inform about an additional research question because that would affect the results ; this question entailed no risk and would be clarified after follow up ; and the ethics committee approved this study .1 After we got consent we r and omised patients . We informed patients in the intervention group about the outreach care programme and asked them to participate , but we kept them ignorant that we were study ing the programme for effectiveness . Controls received no further information . After follow up , we sent all participants a",
"Background – Transient ischemic attack ( TIA ) and stroke patients often show a striking lack of knowledge about their disease . We developed a computer program that provided health education fitting the educational level , risk profile and symptoms of patients and evaluated it in a r and omized controlled trial",
"BACKGROUND Reduction of blood pressure ( BP ) after stroke or TIA decreases stroke recurrence and is a major goal of secondary Stroke Prevention Clinics ( SPCs ) . Health care providers need effective screening processes to identify those clients at highest risk of not achieving BP targets and those clients at highest risk ofnon-adherence to medication . METHODS This multicentred , r and omized controlled study used a screening process to identify SPC patients with psychosocial/cognitive deficits ( e.g. , lack of confidence in the utility of medications , poor memory , mild cognitive impairment ) who were experiencing difficulty managing their BP to target values and evaluated whether a model of nurse-led case management program ( monthly telephone calls , motivational interviewingfor lifestyle change , plus home BP monitoring and use ofdosettes for medication administration ) would improve BP measures and adherence to medications . RESULTS Both intervention ( n=29 ) and usual care groups ( n=27 ) showed a trend-for'reduced BP at six months ( Median ql-q3 , Systolic BR p=0.46 ; Diastolic BR p=0.37 ) . Diabetic patients , irrespective of the group to which they were r and omized , were less likely to meet Best Practice Guideline targets than those without diabetes ( Chi Square test , p=0.0001 ) . CONCLUSION Stroke and TIA patients with diabetes may require additional re sources and support in order to reach BP target values",
"OBJECTIVES To assess the efficacy of a comprehensive secondary prevention programme to reduce morbidity and mortality in patients who have suffered a cardiovascular ( CV ) event ; to control CV risk factors and prophylactic treatment in order to prevent recurrence ; and to improve the quality of life of patients with cardiovascular disease . DESIGN R and omised , pragmatic , open clinical trial in primary care . SETTING A total of 42 primary care centres of 8 different areas in Spain . PARTICIPANTS Men and women below 86 years old , diagnosed with coronary disease and /or stroke and /or peripheral vascular disease in the preceding year , and who have no serious or terminal disease . INTERVENTION Primary care centres will be r and omised to following usual care ( control group ) , or to following a comprehensive programme of secondary prevention ( intervention group ) . MAIN MEASUREMENTS Cardiovascular fatal events , cardiovascular non-fatal events , total mortality and health-related quality of life ( SF-36 )",
"AIM This paper reports a study evaluating the short-term impact of nursing-led , co-ordinated care after discharge following carotid endarterectomy . BACKGROUND Patient education about stroke risk factors , combined systematic ally with carotid endarterectomy , holds unrealized potential to improve patient outcomes . Nurses are well-placed in the healthcare system to co-ordinate this type of education . METHODS A r and omized controlled trial was conducted between October 2001 and October 2002 . Patients having carotid endarterectomy ( n = 133 ) were r and omized to either the intervention ( n = 66 ) or control group ( n = 67 ) . The intervention consisted of telephone liaison with the patient by a Registered Nurse at 2 , 6 and 12 weeks following carotid endarterectomy , combined with education about stroke risk factor management and structured liaison with the patient 's surgeon and referring general practitioner . While patients allocated to the control group did not receive any postoperative telephone contact directly from the Registered Nurse during the study , their general practitioners received structured postoperative liaison . RESULTS The co-ordinated care postdischarge intervention had a statistically significant positive effect on patient knowledge of stroke warning signs ( P = 0.002 ) , patient self-reported changes to improve lifestyle ( P = 0.006 ) and diet modification ( P vascular surgery patients is needed",
"BACKGROUND Determinants of survival and of risk of vascular events after transient ischaemic attack ( TIA ) or minor ischaemic stroke are not well defined in the long term . We aim ed to re study these risks in a prospect i ve cohort of patients after TIA or minor ischaemic stroke ( Rankin grade METHODS We assessed the survival status and occurrence of vascular events in 2473 participants of the Dutch TIA Trial ( recruitment in 1986 - 89 ; arterial cause of cerebral ischaemia ) . We included 24 hospitals in the Netherl and s that recruited at least 50 patients . Primary outcomes were all-cause mortality and the composite event of death from all vascular causes , non-fatal stroke , and non-fatal myocardial infa rct ion . We assessed cumulative risks by Kaplan-Meier analysis and prognostic factors with Cox univariate and multivariate analysis . FINDINGS Follow-up was complete in 2447 ( 99 % ) patients . After a mean follow-up of 10.1 years , 1489 ( 60 % ) patients had died and 1336 ( 54 % ) had had at least one vascular event . 10-year risk of death was 42.7 % ( 95 % CI 40.8 - 44.7 ) . Age and sex-adjusted hazard ratios were 3.33 ( 2.97 - 3.73 ) for age over 65 years , 2.10 ( 1.79 - 2.48 ) for diabetes , 1.77 ( 1.45 - 2.15 ) for claudication , 1.94 ( 1.42 - 2.65 ) for previous peripheral vascular surgery , and 1.50 ( 1.31 - 1.71 ) for pathological Q waves on baseline electrocardiogram . 10-year risk of a vascular event was 44.1 % ( 42.0 - 46.1 ) . After falling in the first 3 years , yearly risk of a vascular event increased over time . Predictive factors for risk of vascular events were similar to those for risk of death . INTERPRETATION Long-term secondary prevention in patients with cerebral ischaemia still has room for further improvement",
"BACKGROUND The number of patients aged 75 + years with cardiovascular diseases ( CVD ) is increasing , but few studies of secondary prevention in this age group exist . The aim of the Drug and Evidence Based Medicine in the Elderly ( DEBATE ) study is to test the applicability and effectiveness of established CVD treatments in elderly patients . METHODS From 1998 to 2000 , population -based postal surveys were performed in Helsinki , Finl and , including the age groups 75 , 80 , 85 , 90 , and 95 years ( n = 4821 ) . Of the 812 individuals reporting any atherosclerotic disease , 400 patients ( 66 % of those eligible ) were included in a r and omized trial . In the intervention group , CVD treatments will be individualized according to current guidelines . A control group will receive the usual care . The trial period will last 2 years with a 3-year extension . The primary end point will be a composite of major CVD . In addition , a number of secondary end points will be recorded , including permanent institutionalization , decline in cognitive and physical function , and quality of life . RESULTS During 2000 , 400 home-dwelling patients were r and omized to the intervention ( n = 199 ) and control ( n = 201 ) groups . The mean age is 80.2 years and 65.3 % are women . Of the participants , 82 % have coronary heart disease ( 41 % with history of myocardial infa rct ion ) , 37 % history of stroke , 19 % non-insulin-dependent diabetes mellitus , and 45 % hypertension , and 6 % are current smokers . Before r and omization , 67 % used aspirin , 40 % b-blockers , 14 % angiotensin-converting enzyme inhibitors , 36 % nitrates , and 20 % lipid-lowering drugs . The groups were well balanced at baseline . CONCLUSION We have successfully r and omized elderly patients with a high degree of comorbidity into a multifactorial CVD prevention trial",
"This paper describes the background and methods of an Agency for Healthcare Research and Quality -funded study design ed to evaluate the impact of a quality improvement model using academic detailing and electronic medical records ( EMRs ) on adherence with 22 clinical practice guidelines for prevention of cardiovascular disease and stroke . The study is being conducted in 23 primary care practice s in 14 states that use a common EMR and pool data for research . Control practice s receive copies of the clinical practice guidelines and quarterly up date s of their adherence with them . Intervention practice s receive similar information and participate in regular site visits and investigator meetings design ed to catalyze their quality improvement efforts . The intervention began January 1 , 2001 and will be completed on June 30 , 2003",
"Abstract Goal : Evidence -based guidelines exist for the prevention and treatment of patients with cerebral ischemia . Despite these guidelines , there are gaps in clinical practice . Our study aim ed to determine if a physician-directed , nurse-case-management program could reduce individual patient vascular risk factors . Methods : Patients hospitalized with atherosclerotic cerebral ischemia with ≥ 1 major uncontrolled risk factor for stroke ( hypertension , tobacco use , dyslipidemia , diabetes ) were eligible to enroll in our study . Patients were r and omized to management by the nurse-prevention program or usual care . Patients in the usual-care group received their initial risk-factor assessment and a scheduled follow-up at 1 year . Patients in the usual-care group underwent further follow-up by primary care and /or neurology as recommended during their hospitalization or outpatient visit . Patients assigned to the prevention group received individualized education , motivational interviewing , and were aided in setting up their risk-factor modification goal plan . Additional education was tailored to each patient based on individualized risk factors . Prevention-group patients also underwent consultation with a registered dietitian and an exercise physiologist . The primary endpoint of the study was improvement of ≥ 1 major patient risk factor for occurrence of stroke to goal at 1 year . Results : At 1-year post-hospitalization , patients in the nurse-care-management group were 42 % more likely to have met the primary endpoint ( n = 18 ; 61 % nurse-managed patients ) compared with 33 % ( n = 18 ) of patients undergoing usual care ( P = 0.09 ) . There was no significant reduction in minor risk factors for either patient group . Patients in the prevention group had greater reductions in low-density lipoprotein cholesterol levels ( −38 vs −4 ; P = 0.0083 ) , changes in cardiovascular risk score ( −5.2 vs 1.3 ; P = 0.0033 ) , and had a greater reductions in systolic blood pressure ( −12.2 vs −0.105 ; P = 0.07 ) than their usual-care counterparts ( changes shown respectively ) . Patients in the prevention group were more likely to follow a prescribed diet than those in the usual-care group ( 50 % ) vs 7 % , respectively ; P = 0.0070 ) and maintain an exercise program ( 83 % vs 33 % , respectively ; P = 0.0018 ) . Summary : A physician-directed , nurse case-management system for patients post-hospitalization for cerebral ischemia is feasible and may help improve long-term control of major patient risk factors for stroke . A larger trial is needed to verify trends noted in our study",
"BACKGROUND Although some studies have demonstrated that pharmacist intervention can improve drug therapy among patients with cardiovascular disease ( CVD ) , more evidence derived from r and omized controlled trials ( RCTs ) is needed , including assessment of the effect of community pharmacist interventions in patients with CVD . OBJECTIVE To assess the effectiveness of the Dader Method for pharmaceutical care on achieving therapeutic goals for blood pressure ( BP ) , total cholesterol ( TC ) , and both BP and TC ( BP/TC ) in patients with CVD and /or high or intermediate cardiovascular ( CV ) risk attending community pharmacies in Spain . METHODS Patients aged 25 to 74 years attending community pharmacies with a prescription for at least 1 drug indicated for CVD or CV risk factors were r and omized to 2 groups : an intervention group that received pharmaceutical care , which was provided by specially trained pharmacists working in collaboration with physicians , and a control group that received usual care ( routine dispensing counseling ) and verbal and written counseling regarding CVD prevention . Patients were recruited from December 2005 to September 2006 , and both groups were followed for 8 months . Study outcomes were assessed at baseline and at 16 and 32 weeks after r and omization . The primary outcome measures were the proportions of patients achieving BP , TC , and BP/TC therapeutic goals ( BP lower than 140/90 mm Hg for patients with uncomplicated hypertension and lower than 130/80 mm Hg for patients with diabetes , chronic kidney disease , or history of myocardial infa rct ion or stroke ; TC lower than 200 mg per dL for patients without CVD and lower than 175 mg per dL for patients with CVD ) . Secondary outcomes were mean BP and TC values . BP was assessed manually by the pharmacist after a 10-minute rest in the supine position . This measurement was performed twice for every participant , and the average of the 2 measurements was calculated . TC was measured by the pharmacist during the study visit using the enzymatic dry method . Statistical analyses were performed using 2-tailed McNemar tests , Pearson chi-square tests , and Student 's t-tests ; P RESULTS 714 patients were included in the study ( 356 intervention , 358 control ) , and the mean [ SD ] age was 62.8 [ 8.1 ] years . The 2 groups were similar at baseline in clinical and demographic characteristics , including the proportion of patients at therapeutic goals for BP , TC , and BP/TC . After 8 months of follow-up , there were statistically significant differences in favor of pharmaceutical care in the proportions of patients who achieved therapeutic goals for BP ( 52.5 % vs. 43.0 % , P=0.017 ) , TC ( 56.5 % vs. 44.1 % , P=0.001 ) , and BP/TC ( 37.1 % vs. 21.8 % , P with usual care plus written education , pharmaceutical care focused on patient evaluation and follow-up in collaboration with physicians improved the achievement of BP , TC , and BP/TC treatment goals in patients with CVD and /or high or intermediate CV risk attending community pharmacies in Spain",
"OBJECTIVE To evaluate the adequacy of management of modifiable risk factors ( MRF ) in a group of ischemic stroke out patients and the value of pharmacist intervention in a r and omized controlled study in a tertiary referral hospital . METHODS 160 ischemic stroke out patients from the same catchment area and with the same financial arrangements for healthcare , went through a 6-month equal allocation stratified r and omized study . Routine practice was not altered except for a monthly 1-hour pharmacist-intervention education programme . We evaluated the differences in blood pressure ( BP ) , blood glucose and lipid profiles before and after study . The proportion of patients with adequate management of MRF was studied . RESULTS There were no differences in the demographic characteristics , MRF and medications prescribed throughout the study . Before the study , the proportions of adequate control of BP in the control and intervention groups were 43 % vs. 40 % ( P = 0.64 ) , lipid 27 % vs. 13 % ( P = 0.09 ) and glucose 36 % vs. 21 % ( P = 0.15 ) . At the end of the study , the corresponding proportions were for BP 43 % vs. 83 % ( P = 0.00 ) , lipid 27 % vs. 40 % ( P = 0.16 ) and glucose 46 % vs. 35 % ( P = 0.40 ) . CONCLUSION Pharmacist intervention was associated with improved BP control but not with the other MRF . Earlier initiation and longer duration of intervention may improve the outcome further , and whether targeting of high-risk subjects may be particularly rewarding is worthy of investigation",
"STUDY OBJECTIVE To evaluate whether a simple pharmacist protocol , consisting of patient screening and cardiovascular risk stratification , identification and reminders about uncontrolled risk factors , and drug adherence support , can significantly reduce cardiovascular risk . DESIGN Prospect i ve , r and omized , controlled pilot study . SETTING Large primary care medical clinic in Saskatoon , Saskatchewan , Canada . PATIENTS One hundred seventy-six adult patients ( mean age 60 yrs ) who exhibited a 10-year Framingham risk score of 15 % or greater , or a coronary artery disease risk equivalent ( coronary artery disease , peripheral artery disease , cerebrovascular disease , or diabetes mellitus ) . INTERVENTION Eligible patients initially met with the pharmacist to receive general counselling about cardiovascular disease and were then r and omly assigned to receive ongoing follow-up by the pharmacist ( follow-up group [ 88 patients ] ) or to return to usual care ( single-contact group [ 88 patients ] ) for a minimum of 6 months . MEASUREMENTS AND MAIN RESULTS The primary end point was mean reduction in the 10-year Framingham risk score . Secondary end points included individual modifiable risk factors ( systolic and diastolic blood pressures ; total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol [ HDL ] , and triglyceride levels ; total cholesterol : HDL ratio ; and hemoglobin A(1c ) value ) , as well as statin utilization , initiation , and adherence rates . Baseline characteristics were similar across both groups . Neither the mean reduction in 10-year risk ( -2.68 for the follow-up group and -1.25 for the single-contact group , one-tailed p=0.098 ) nor individual risk factors were significantly different between groups . The proportion of patients exhibiting statin adherence of 80 % or greater did not significantly differ between groups at study end ( 73.1 % [ 57/78 ] and 80.0 % [ 52/65 ] , respectively , p=0.333 ) . However , 85.2 % ( 75/88 ) in the follow-up group continued with statin therapy at the end of the study compared with 67.0 % ( 59/88 ) in the single-contact group ( p=0.005 ) . Statin initiations were more frequent in the follow-up group than in the single-contact group ( 75.0 % [ 30/40 ) vs 48.9 % [ 22/45 ] , p=0.013 ) . CONCLUSION This simple cardiovascular care protocol for nonspecialist pharmacists did not result in a clear improvement to cardiovascular risk reduction success among patients in a primary care medical clinic . The intervention did , however , appear to improve statin utilization",
"Background and Purpose — Stroke recurrence rates are high ( 20%–25 % ) and have not declined over past 3 decades . This study tested effectiveness of motivational interviewing ( MI ) for reducing stroke recurrence , measured by improving adherence to recommended medication and lifestyle changes compared with usual care . Methods — Single-blind , prospect i ve phase III r and omized controlled trial of 386 people with stroke assigned to either MI treatment ( 4 sessions at 28 days , 3 , 6 , and 9 months post stroke ) or usual care ; with outcomes assessed at 28 days , 3 , 6 , 9 , and 12 months post stroke . Primary outcomes were change in systolic blood pressure and low-density lipoprotein cholesterol levels as indicators of adherence at 12 months . Secondary outcomes included self-reported adherence , new stroke , or coronary heart disease events ( both fatal and nonfatal ) ; quality of life ( Short Form-36 ) ; and mood ( Hospital Anxiety and Depression Scale ) . Results — MI did not significantly change measures of blood pressure ( mean difference in change , −0.2.35 [ 95 % confidence interval , −6.16 to 1.47 ] ) or cholesterol ( mean difference in change , −0.0.12 [ 95 % confidence interval , −0.30 to 0.06 ] ) . However , it had positive effects on self-reported medication adherence at 6 months ( 1.979 ; 95 % confidence interval , 0.98–3.98 ; P=0.0557 ) and 9 months ( 4.295 ; 95 % confidence interval , 1.56–11.84 ; P=0.0049 ) post stroke . Improvement across other measures was also observed , but the differences between MI and usual care groups were not statistically significant . Conclusions — MI improved self-reported medication adherence . All other effects were nonsignificant , though in the direction of a treatment effect . Further study is required to determine whether MI leads to improvement in other important areas of functioning ( eg , caregiver burden ) . Clinical Trial Registration — URL : http://www.anzctr.org.au . Unique identifier : ACTRN-12610000715077",
"How do you obtain a valid assessment of subjective outcomes in a trial in which the participants can not be blinded to the intervention ? Bias is inevitable from unblinded patients , but trials that have not told patients about treatment in all arms have been heavily criticised . Asking participants to consent to postponed information could be a solution The most powerful tool for study ing the effectiveness of a medical treatment is a r and omised controlled clinical trial with blinded assessment of outcomes . However , blinding is not always possible — for example , in a trial comparing a surgical intervention with non-surgical treatment or the effectiveness of supplemental care compared with conventional care . Blinding needs special attention in such studies in order to prevent bias . When outcomes are assessed by doctors , it is often easy for the assessment to be done by doctors other than those who performed the procedure . However , when studies measure patients ' assessment of outcomes , blinding is much more complicated or even impossible . ! [ ] [ 1 ] Credit : PETER GRAY Unblinded patients who assess outcomes after being informed about the different treatment options during recruitment might bias the results of a study . The likelihood of bias increases when patients have a preference for one of the treatment options . For example , patients may have been told during recruitment that the new or supplemental strategy has been developed because the current strategy has disadvantages . The best way to obtain valid assessment s in such studies remains unclear . Intense debate was generated when research ers tried to mask patients … [ 1 ] :",
"SIR— Interventions with an educational or counselling component have been reported to be effective in a variety of patient groups to encourage smoking cessation [ 1 ] , lower blood pressure ( BP ) [ 2 , 3 ] , achieve modest reductions in cholesterol [ 4 ] , and promote weight loss [ 5 ] . Evaluation of the impact of education on physical outcomes is lacking in stroke disease , despite evidence that inadequate provision of information may adversely affect compliance with secondary prevention and psychosocial outcomes [ 6 ] . We describe a single-blind r and omised controlled trial of health education and counselling for patients with stroke or transient ischaemic attack ( TIA ) , and its effects on risk factors , satisfaction , mood and perceived health status",
"Background Small subcortical strokes , also known as lacunar strokes , comprise more than 25 % of brain infa rcts , and the underlying vasculopathy is the most common cause of vascular cognitive impairment . How to optimally prevent stroke recurrence and cognitive decline in S3 patients is unclear . The aim of the Secondary Prevention of Small Subcortical Strokes study ( Trial registration : NCT00059306 ) is to define strategies for reducing stroke recurrence , cognitive decline , and major vascular events . Methods Secondary Prevention of Small Subcortical Strokes is a r and omised , multicentre clinical trial ( n=3000 ) being conducted in seven countries , and sponsored by the US NINDS/NIH . Patients with symptomatic small subcortical strokes in the six-months before and an eligible lesion on magnetic resonance imaging are simultaneously r and omised , in a 2 × 2 factorial design , to antiplatelet therapy – 325 mg aspirin daily plus 75 mg clopidogrel daily , vs. 325 mg aspirin daily plus placebo , double-blind – and to one of two levels of systolic blood pressure targets –‘intensive ’ ( Participants are followed for an average of four-years . Time to recurrent stroke ( ischaemic or haemorrhagic ) is the primary outcome and will be analysed separately for each intervention . The secondary outcomes are the rate of cognitive decline and major vascular events . The primary and most secondary outcomes are adjudicated central ly by those unaware of treatment assignment . Conclusions Secondary Prevention of Small Subcortical Strokes will address several important clinical and scientific questions by testing two interventions in patients with recent magnetic resonance imaging-defined lacunar infa rcts , which are likely due to small vessel disease . The results will inform the management of millions of patients with this common vascular disorder",
"OBJECTIVE We aim ed to examine whether better use of preventive methods and treatments of cardiovascular disease would reduce recurrent events in home-dwelling patients 75 years or older . METHODS This was a r and omized , controlled trial ( a practical clinical trial , the DEBATE ) , conducted in 2000 to 2003 in Helsinki , Finl and . We recruited 400 vascular patients with mean age of 80 years from the community , and they were r and omly assigned to the intervention group ( n = 199 ) where both nonpharmacological and pharmacological cardiovascular treatments were optimized by a geriatrician according to current guidelines . The control group ( n = 201 ) received the usual care . Main outcome measures were major cardiovascular disease events and total mortality and changes in risk factors and medications . RESULTS The groups were balanced at baseline . Mean duration of follow-up was 3.4 years . At 3 years , drug treatments had become more evidence -based in the intervention group . Consequently , total and low-density lipoprotein cholesterol levels ( P systolic ( P = .005 ) and diastolic ( P = .009 ) blood pressure were significantly improved in the intervention group . However , neither primary end points ( 52 and 53 events in the intervention and control groups , respectively ) nor total mortality ( 36 and 35 deaths ) were significantly different between the two groups . No special adverse effects were encountered . CONCLUSION It was possible and safe to institute evidence -based cardiovascular treatments and improve risk factors in patients 75 years or older in a pragmatic setting . During 3.4 years , however , this was not converted to clinical benefits",
"Objectives . Ethnic minority groups are at a higher risk of stroke and heart disease . However , design ing effective prevention strategies requires responding to the needs of different ethnic groups . The aims of this study were to estimate the prevalence of four behavioural risk factors ( smoking , drinking , exercise and weight ) for stroke among Black Caribbeans , Black Africans and Whites , and also to examined reported willingness to change these behaviours . Design . A r and om sample of 311 Black Caribbean , 300 White , and 105 Black Africans aged 45 - 74 registered with 16 practice s in south London were surveyed in 1995 . Information was obtained on smoking , drinking and exercise patterns , body mass index and perceptions of being at risk of stroke , and willingness to change risk behaviour . Results . White respondents ( 31 % age and sex st and ardised prevalence ) were more likely to smoke than Black Caribbeans ( 23 % ) and Black Africans ( 10 % ) ( p Self-reported rates of drinking were higher than the government 's ' sensible drinking levels ' for 19 % of Whites , 11 % of Black Caribbeans and 4 % Black Africans ( p overweight ( BMI > 27 ) than Black Caribbeans ( 60 % ) and Black Africans ( 68 % ) ( p = 0.001 ) . A high proportion of smokers wished to give up ( 89 % Black African ; 83 % Black Caribbean ; 74 % White ) . A higher proportion of Black Caribbeans ( 35 % ) reported a willingness to reduce their alcohol intake compared to only 15 % of Whites ( p = 0.040 ) . There was a difference between groups in attitudes to weight reduction with 69 % Black Caribbean women expressing a desire to be thinner compared to 86 % Whites and 82 % Black Africans ( p = 0.051 ) . Conclusion . Strategies to reduce behavioural risk factors for heart attack and stroke need to emphasise different risk factors among ethnic groups , especially in relation to alcohol use in the White population and weight in the Black Caribbean population . Influencing the change of these behaviours requires working in partnership with local community groups",
"BACKGROUND Approximately one third of the 780,000 people in the United States who have a stroke each year have recurrent events . Although efficacious secondary prevention measures are available , levels of adherence to these strategies in patients who have had stroke are largely unknown . Underst and ing medication-taking behavior in this population is an important step to optimizing the appropriate use of proven secondary preventive therapies and reducing the risk of recurrent stroke . METHODS The Adherence eValuation After Ischemic Stroke Longitudinal ( AVAIL ) registry is a prospect i ve study of adherence to stroke prevention medications from hospital discharge to 1 year in patients admitted with stroke or transient ischemic attack . The primary outcomes are medication usage as determined by patient interviews after 3 and 12 months . Potential patient- , provider- , and system-level barriers to persistence of medication use are also collected . Secondary outcomes include the rates of recurrent stroke or transient ischemic attack , vascular events , and rehospitalization and functional status as measured by the modified Rankin score . RESULTS The AVAIL enrolled about 2,900 subjects from 106 hospitals from July 2006 through July 2008 . The 12-month follow-up will be completed in August 2009 . CONCLUSIONS The AVAIL registry will document the current state of adherence and persistence to stroke prevention medications among a nationwide sample of patients . These data will be used to design interventions to improve the quality of care post acute hospitalization and reduce the risks of future stroke and cardiovascular events",
"BACKGROUND Survivors of ischemic stroke/transient ischemic attack ( TIA ) are at high risk for other vascular events . We evaluated the impact of 2 types of case management ( hard touch with pharmacist or soft touch with nurse ) added to usual care on global vascular risk . METHODS This is a prespecified secondary analysis of a 6-month trial conducted in out patients with recent stroke/TIA who received usual care and were r and omized to additional monthly visits with either nurse case managers ( who counseled patients , monitored risk factors , and communicated results to primary care physicians ) or pharmacist case managers ( who were also able to independently prescribe according to treatment algorithms ) . The Framingham Risk Score [ FRS ] ) and the Cardiovascular Disease Life Expectancy Model ( CDLEM ) were used to estimate 10-year risk of any vascular event at baseline , 6 months ( trial conclusion ) , and 12 months ( 6 months after last trial visit ) . RESULTS Mean age of the 275 evaluable patients was 67.6 years . Both study arms were well balanced at baseline and exhibited reductions in absolute global vascular risk estimates at 6 months : median 4.8 % ( Interquartile range ( IQR ) 0.3%-11.3 % ) for the pharmacist arm versus 5.1 % ( IQR 1.9%-12.5 % ) for the nurse arm on the FRS ( P = .44 between arms ) and median 10.0 % ( 0.1%-31.6 % ) versus 12.5 % ( 2.1%-30.5 % ) on the CDLEM ( P = .37 ) . These reductions persisted at 12 months : median 6.4 % ( 1.2%-11.6 % ) versus 5.5 % ( 2.0%-12.0 % ) for the FRS ( P = .83 ) and median 8.4 % ( 0.1%-28.3 % ) versus 13.1 % ( 1.6%-31.6 % ) on the CDLEM ( P = .20 ) . CONCLUSIONS Case management by nonphysician providers is associated with improved global vascular risk in patients with recent stroke/TIA . Reductions achieved during the active phase of the trial persisted after trial conclusion",
"Proven strategies to reduce risk of stroke recurrence are under‐utilized . We sought to evaluate the impact of st and ardized stroke discharge orders on treatment practice s in a cluster‐r and omized trial"
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Cognitive dysfunction is of clinical significance and exerts longst and ing implication on patients ׳ function . Pharmacological and non-pharmacological treatments of cognitive dysfunction are emerging . This review evaluates pharmacological and non-pharmacological treatments of cognitive impairment primarily in the domains of memory , attention , processing speed and executive function in clinical depression . A total of 35 studies were retrieved from Pubmed , PsycInfo and Scopus after applying inclusion and exclusion criteria . Results show that various classes of antidepressants exert improving effects on cognitive function across several cognitive domains . Specifically , studies suggest that SSRIs , the SSRE tianeptine , the SNRI duloxetine , vortioxetine and other antidepressants such as bupropion and moclobemide may exert certain improving effects on cognitive function in depression , such as in learning and memory and executive function . Class-specific cognitive domains or specific dose-response relationships were not identified yet . The few non-pharmacological studies conducted employing cognitive orientated treatments and cognitive remediation therapy show promising results for the improvement of cognitive impairment in depression . However , several method ological constraints of studies limit generalizability of the results and caution the interpretation . Future direction should consider the development of a neuropsychological consensus cognitive battery to support the discovery , clinical assessment , comparison of studies and registration of new agents in clinical depression
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[
"ObjectiveS uicidal ideation has been related to cognitive rigidity whereas suicidal behaviour itself was associated with specific executive deficits . Yet it remains unclear if a distinct cognitive suicidal phenotype does exist . The aim of the present study was to further investigate the role of suicidal thinking for the neuropsychological performance in depressive suicide attempters . Method Depressive in patients after a recent suicide attempt , who either had present suicidal ideation ( n = 14 ) or not ( n = 15 ) and healthy controls ( n = 29 ) were recruited . The groups were assessed by means of executive tasks design ed to capture impulsive decision-making , and with verbal memory and attention tests . Self-rating measures of impulsivity and aggression were further applied . Results Only patients with current suicidal ideation showed executive dysfunctions with impaired decision-making being the most salient . Verbal memory and attention were reasonably intact in all patients . All patients reported increased aggression . ConclusionS uicidal ideation is clearly associated with impaired cognitive performance . Our results suggest that executive deficits seen in depressive suicide attempters have a state-dependent component",
"PURPOSE Dysfunctions of auditory-verbal declarative and working memory are observed in patients with depressive disorders ( DD ) . The authors wanted to see , whether antidepressive therapy improved the efficiency of cognitive processes among patients suffering from DD and determine possible associations between auditory-verbal declarative and working memory performance , evaluated before treatment vs. remission degree after treatment . MATERIAL AND METHODS The study was carried out in 87 subjects , patients with depressive disorders ( n=30 , DD ) and healthy subjects ( n=57 , CG , control group ) . The AVLT ( Auditory Verbal Learning Test ) and the Stroop Test were used . RESULTS CG obtained higher results vs. DD-I ( the evaluation started on the therapy onset ) in the Stroop Test-RCNb ( Reading Colour Names in Black)/time , NCWd ( Naming Colour of Word - Different)/time , NCWd/errors , AVLT : the number of words after 30 minutes . CG demonstrated higher results than DD-II ( following eight weeks of pharmacological treatment ) in RCNb/time , NCWd/time , AVLT : the number of words in the first trial , the number of words after 30 minutes . Compared to DD-I , DD-II achieved better results in NCWd/errors . No statistically significant differences were observed in both tests between the patients with remission and without remission . Statistical analysis revealed the lack of significant dependences among HDRS after treatment and cognitive functions before treatment . CONCLUSIONS Depressive disorders are associated with deteriorated efficiency of auditory-verbal declarative and working memory . No improvement was observed in the efficiency of auditory-verbal declarative or working memory after 8-week therapy . The performance level of cognitive processes before pharmacotherapy has no effect on the intensity of depression symptoms after therapy",
"The respective effects of three antidepressant drugs ( moclobemide , 450 mg/j ; viloxazine , 300 mg/j ; maprotiline , 150 mg/j ) on vigilance , attention , and memory were compared . Young depressed out patients ( n=46 ) entered a double-blind , r and omised , monocentre clinical trial lasting for 6 weeks . Drug actions were assessed through the regular determination of critical flicker fusion point ( CFF ) , reaction times ( SRT ) , and a battery to measure memory components . None of the three drugs caused deterioration in cognitive functions . On the other h and , moclobemide improved both vigilance and attention ( CFF , SRT ) and some crucial components of memory ( general memory scores , delayed word recall , recognition of familiar faces ) . This effect was rapid , stable , and superior to those of viloxazine and maprotiline . It may be explained by moclobemide 's selective and reversible inhibition of monoamine oxidase A , as well as by the lack of any anticholinergic action",
"Depression is a common disorder in the elderly h and icapping patients with affective and cognitive symptoms . Because of their good tolerability relative to the older tricyclic compounds , selective serotonin reuptake inhibitors ( SSRIs ) are increasingly used for the treatment of depression in the elderly . Little is known about their effects on cognition in elderly patients . In the present 4-wk , single-centre , r and omized , open-label trial we investigated the antidepressive effects of escitalopram , an SSRI , in 18 elderly depressed patients [ mean age ( + /-s.e.m . ) 76.2+/-1.8 yr ] compared to 22 healthy age-matched controls ( mean age 76.9+/-1.8 yr ) . Affective and cognitive symptoms were assessed using the Geriatric Depression Scale ( GDS ) , Mini-Mental State Examination ( MMSE ) , and a face portrait recognition test to assess memory for happy and angry faces . Depressed patients prior to treatment had markedly reduced memory performance . Treatment with escitalopram improved affective and cognitive symptoms significantly . Furthermore , escitalopram treatment improved memory for negative facial stimuli . Control subjects confirmed the well- established memory bias favouring recognition of identities acquired with happy expressions . Importantly , this bias was absent in depressed patients prior to , but also after treatment . In conclusion , escitalopram , even after a relatively short treatment period , was effective in treating depression in the elderly and may help improve cognitive performance for social stimuli",
"Cognitive functions are impaired in Major Depression . Studies on the effects of Yoga on cognitive functions have shown improvement in memory , vigilance and anxiety levels . 30 patients suffering from Major depression ( age 18 to 45 years ) were r and omly divided into two groups : Group 1 : ( 10 males and 5 Females ) Patients who practised Sahaj Yoga meditation and also received conventional anti-depressant medication . Group 2 : ( 9 males and 6 Females ) Patients who only received conventional antidepressant medication . Group 1 patients were administered Sahaj Yoga practice for 8 weeks . Neuro-cognitive test battery consisting of Letter cancellation test ( LCT ) , Trail making test ' A ' ( TTA ) , Trail making test ' B ' ( TTB ) , Ruff figural fluency test ( RFFT ) , Forward digit span ( FDS ) & Reverse digit span test ( RDS ) was used to assess following cognitive domains : Attention span , visuo-motor speed , short-term memory , working memory and executive functions . After 8 weeks , both Group 1 and Group 2 subjects showed significant improvement in LCT , TTA & TTB but improvement in LCT was more marked in Group 1 subjects . Also , there was significant improvement in RDS scores in only Group 1 subjects ( P Sahaj Yoga practice in addition to the improvement in various other cognitive domains seen with conventional anti-depressants , can lead to additional improvement in executive functions like manipulation of information in the verbal working memory and added improvement in attention span and visuo-motor speed of the depressives",
"Patients with schizophrenia have consistently been found to exhibit cognitive deficits , particularly in memory , which have been suggested to mediate functional outcomes . Several recent review s of cognitive retraining have concluded that these deficits respond to training , although the sustainability of cognitive improvement following completion of training has not been adequately evaluated . Most studies had small sample s and very short follow-up periods . As part of a larger study , we examined performance on two memory tasks in two groups of participants : those who received computerized cognitive remediation training in addition to work therapy ( n=45 ) , vs. those who only received work therapy ( n=49 ) . Computerized cognitive remediation included hierarchical training on a computerized digit span task and a computerized words serial position task . Assessment s using the same computerized tasks were made at three time points : baseline , end of active intervention , and 6-month follow-up . Compared to the active control condition ( work therapy only ) , the group receiving computerized cognitive remediation in addition to work therapy showed significantly greater improvements on the trained digit span task following training . These improvements were maintained at the 6-month follow-up . There were no significant group differences on the word serial position task at any time point . Results indicate that computerized training can lead to sustained improvements on some , but not all , training tasks",
"BACKGROUND Tricyclic antidepressants and serotonin reuptake inhibitors are considered to be equally effective , but differences may have been obscured by internally inconsistent measurement scales and inefficient statistical analyses . AIMS To test the hypothesis that escitalopram and nortriptyline differ in their effects on observed mood , cognitive and neurovegetative symptoms of depression . METHOD In a multicentre part-r and omised open-label design ( the Genome Based Therapeutic Drugs for Depression ( GENDEP ) study ) 811 adults with moderate to severe unipolar depression were allocated to flexible dosage escitalopram or nortriptyline for 12 weeks . The weekly Montgomery-Asberg Depression Rating Scale , Hamilton Rating Scale for Depression , and Beck Depression Inventory were scored both conventionally and in a more novel way according to dimensions of observed mood , cognitive symptoms and neurovegetative symptoms . RESULTS Mixed-effect linear regression showed no difference between escitalopram and nortriptyline on the three original scales , but symptom dimensions revealed drug-specific advantages . Observed mood and cognitive symptoms improved more with escitalopram than with nortriptyline . Neurovegetative symptoms improved more with nortriptyline than with escitalopram . CONCLUSIONS The three symptom dimensions provided sensitive descriptors of differential antidepressant response and enabled identification of drug-specific effects",
"Background Selective serotonin reuptake inhibitors ( SSRIs ) are popular medications for anxiety and depression , but their effectiveness , particularly in patients with prominent symptoms of loss of motivation and pleasure , has been question ed . There are few studies of the effect of SSRIs on neural reward mechanisms in humans . Methods We studied 45 healthy participants who were r and omly allocated to receive the SSRI citalopram , the noradrenaline reuptake inhibitor reboxetine , or placebo for 7 days in a double-blind , parallel group design . We used functional magnetic resonance imaging to measure the neural response to rewarding ( sight and /or flavor of chocolate ) and aversive stimuli ( sight of moldy strawberries and /or an unpleasant strawberry taste ) on the final day of drug treatment . Results Citalopram reduced activation to the chocolate stimuli in the ventral striatum and the ventral medial/orbitofrontal cortex . In contrast , reboxetine did not suppress ventral striatal activity and in fact increased neural responses within medial orbitofrontal cortex to reward . Citalopram also decreased neural responses to the aversive stimuli conditions in key “ punishment ” areas such as the lateral orbitofrontal cortex . Reboxetine produced a similar , although weaker effect . Conclusions Our findings are the first to show that treatment with SSRIs can diminish the neural processing of both rewarding and aversive stimuli . The ability of SSRIs to decrease neural responses to reward might underlie the question ed efficacy of SSRIs in depressive conditions characterized by decreased motivation and anhedonia and could also account for the experience of emotional blunting described by some patients during SSRI treatment",
"Selective serotonin reuptake inhibitors ( SSRIs ) are widely used as effective pharmacological agents to treat depressive disorders . In contrast to the SSRIs , which block the presynaptic serotonin ( 5-HT ) transporter and by this route increase the concentration of serotonin in the synaptic cleft , the antidepressant tianeptine enhances the presynaptic neuronal reuptake of 5-HT and thus decreases serotonergic neurotransmission . Both SSRIs and tianeptine are clinical ly effective ; however , their opposite modes of action challenge the prevailing concepts on the need of enhancement of serotonergic neurotransmission . To better underst and the differences between these two opposite pharmacological modes of action , we compared the changes induced by tianeptine and paroxetine on psychopathology , the hypothalamic-pituitary-adrenocortical ( HPA ) system , and cognitive functions in a double-blind , r and omized , controlled trial including 44 depressed in patients over a period of 42 days . Depressive symptomatology significantly improved in all efficacy measures , with no significant differences between tianeptine and paroxetine . There was a trend toward better response to the SSRI among women . Assessment of the HPA system showed marked hyperactivity before the beginning of treatment , which then normalized in most of the patients , without significant differences between the two antidepressants . Cognitive assessment s showed no significant differences between the two drugs investigated . The results of the current study suggest that the initial effect , i.e. , enhancement or decrease of 5-HT release , is only indirectly responsible for antidepressant efficacy , and they support the notion that downstream adaptations within and between nerve cells are crucial . The normalization of the HPA system as a common mode of action of different antidepressants seems to be of special interest",
"Accumulating evidence suggests that noradrenergic and serotonergic drugs are equally effective in ameliorating the depressive symptoms of major depression . Major depression is associated also with memory impairments , but the comparative effects of the antidepressant drugs on memory are not clear . We previously found that serotonergic neurotransmission is of particular importance for some aspects of episodic memory . We set out to test whether treatment with the selective serotonergic drug Fluoxetine ( Prozac ) would be advantageous in this respect over treatment with the selective noradrenergic tricyclic antidepressant drug Desipramine ( Deprexan ) . Seventeen patients with major depressive episode , r and omly assigned for treatment with either Fluoxetine ( n = 8) or Desipramine ( n = 9 ) , were assessed for their clinical situation and for memory performance at the beginning of treatment , after 3 weeks , and after 6 weeks of pharmacological treatment . We found that although clinical ly both drugs were equally effective , the improvement of memory performance in the Fluoxetine-treated patients was significantly greater compared with that of the Desipramine-treated patients . The results support the role of serotonin in memory . More studies in larger sample s of patients are required , but it may be that in cases where memory impairment is a major symptom , it would be beneficial to consider serotonergic antidepressant drugs for treatment . Furthermore , in cases where , for various reasons , the treatment of choice is noradrenergic , it may be worthwhile to consider a supplementary serotonergic drug to improve memory deficits",
"BACKGROUND Cognitive deficits are a major determinant of social and occupational dysfunction in schizophrenia . In this study , we determined whether neurocognitive enhancement therapy ( NET ) in combination with work therapy ( WT ) would improve performance on neuropsychological tests related to but different from the training tasks . METHODS Sixty-five patients with schizophrenia or schizoaffective disorder were r and omly assigned to NET plus WT or WT alone . Neurocognitive enhancement therapy included computer-based training on attention , memory , and executive function tasks ; an information processing group ; and feedback on cognitive performance in the workplace . Work therapy included paid work activity in job placements at the medical center ( eg , mail room , grounds , library ) with accompanying supports . Neuropsychological testing was performed at intake and 5 months later . RESULTS Prior to enrollment , both groups did poorly on neuropsychological testing . Patients receiving NET + WT showed greater improvements on pretest-posttest variables of executive function , working memory , and affect recognition . As many as 60 % in the NET + WT group improved on some measures and were 4 to 5 times more likely to show large effect-size improvements . The number of patients with normal working memory performance increased significantly with NET + WT , from 45 % to 77 % , compared with a decrease from 56 % to 45 % for those receiving WT . CONCLUSIONS Computer training for cognitive dysfunction in patients with schizophrenia can have benefits that generalize to independent outcome measures . Efficacy may result from a synergy between NET , which encourages mental activity , and WT , which allows a natural context for mental activity to be exercised , generalized , and reinforced",
"Cognitive dysfunction is common in older persons suffering from a major depression . However , the degree to which this dysfunction is reversible with successful treatment of the depression remains uncertain . The present study examined the effects that treatment ( r and omized double-blind design ) with either an SSRI ( paroxetine ) or a tricyclic antidepressant ( nortriptyline ) had on cognition in older depressed patients . The patients ' performance was compared to that of a group of normal controls of similar age and education . Patients and controls were administered measures of working memory , information-processing speed , episodic memory and attention five times over the course of a 12 week trial . At baseline , the patients performed more poorly than the elderly controls on all cognitive measures . While the patients ' performance did improve over the course of their treatment , the magnitude of this improvement did not exceed that produced in the elderly controls by practice alone . The same pattern of results was evident in both intent-to-treat and responder analyses . Thus , there was no evidence that the depressed patients ' cognitive performance normalized after response to antidepressant therapy . Neither the patients ' age at onset nor their baseline level of cognitive functioning influenced the amount by which their performance improved over the 12 week trial . There was no difference between paroxetine and nortriptyline in the amount of cognitive change associated with treatment . The present results suggest that cognitive dysfunction persists in older depressed patients even after their mood disorder has responded to antidepressant medications",
"In a previous study , we found that cognitive adaptation training (CAT)--a manual-driven program of environmental supports design ed to bypass cognitive deficits -- improved multiple domains of outcome in schizophrenia patients recently discharged from a State psychiatric facility . The present study examined the efficacy of CAT in a sample of patients who had been in the community at least 3 months . Forty-five medicated schizophrenia patients were r and omly assigned for 9 months to one of three conditions : ( 1 ) CAT , ( 2 ) a condition that controlled for therapist time and provided environmental changes unrelated to cognitive deficits , or ( 3 ) follow-up only . Comprehensive assessment s were conducted every 3 months by blinded raters . Results of repeated measures analyses of covariance for mixed models indicated that patients participating in CAT had better adaptive function and quality of life , and fewer positive symptoms than those in the two non-CAT conditions . Results indicate that compensatory strategies may improve various outcomes in schizophrenia out patients",
"OBJECTIVE The aim of this study was to compare over 1 year the effect of sertraline and citalopram on depressive symptoms and cognitive functions of nondemented elderly patients with minor depressive disorder and subsyndromal depressive symptomatology . METHOD We recruited 138 consecutive non-demented out patients of either sex , aged > or = 65 years , who were classified as meeting research criteria for minor depressive disorder or sub-syndromal depressive symptomatology using the Structured Clinical Interview for DSM-IV . Subjects were assigned to receive citalopram 20 mg/day ( 66 patients ) or sertraline 50 mg/day ( 72 patients ) orally for 1 year . Patients were assessed at baseline and after 1 , 2 , 3 , and 6 months and at 1 year by raters masked with regard to patients ' treatment assignments . The Hamilton Rating Scale for Depression , the Geriatric Depression Scale , and the Global Assessment of Functioning were administered to assess the course of depressive symptoms and social functioning during the study . Cognitive measures included Trail Making Test-Parts A and B , Wechsler Memory Scale , Mini-Mental State Examination , and a verbal fluency test . Data were collected from March 2000 to March 2003 . RESULTS The overall completion rate was 72 % . Both treatments induced a significant , sustained , and comparable improvement in depressive symptoms and in social functioning . Nearly half of the subjects in the 2 groups achieved remitter status at study endpoint . Significant within-group improvements also were observed in all cognitive measures . Both drugs were well tolerated during the whole study period . CONCLUSION Our results suggest that sertraline and citalopram can improve depressive symptoms and cognitive functions of minor depressive disorder and subsyndromal depressive symptomatology in elderly nondemented patients",
"OBJECTIVE Acute administration of an antidepressant increases positive affective processing in healthy volunteers , an effect that may be relevant to the therapeutic actions of these medications . The authors investigated whether this effect is apparent in depressed patients early in treatment , prior to changes in mood and symptoms . METHOD In a double-blind , placebo-controlled , between-groups r and omized design , the authors examined the effect of a single 4-mg dose of the norepinephrine reuptake inhibitor reboxetine on emotional processing . Thirty-three depressed patients were recruited through primary care clinics and the community and matched to 31 healthy comparison subjects . Three hours after dosing , participants were given a battery of emotional processing tasks comprising facial expression recognition , emotional categorization , and memory . Ratings of mood , anxiety , and side effects were also obtained before and after treatment . RESULTS Depressed patients who received placebo showed reduced recognition of positive facial expressions , decreased speed in responding to positive self-relevant personality adjectives , and reduced memory for this positive information compared to healthy volunteers receiving placebo . However , this effect was reversed in patients who received a single dose of reboxetine , despite the absence of changes in subjective ratings of mood or anxiety . CONCLUSIONS Antidepressant drug administration modulates emotional processing in depressed patients very early in treatment , before changes occur in mood and symptoms . This effect may ameliorate the negative biases in information processing that characterize mood and anxiety disorders . It also suggests a mechanism of action compatible with cognitive theories of depression",
"CONTEXT Adjunctive restorative therapies administered during the first few months after stroke , the period with the greatest degree of spontaneous recovery , reduce the number of stroke patients with significant disability . OBJECTIVE To examine the effect of escitalopram on cognitive outcome . We hypothesized that patients who received escitalopram would show improved performance in neuropsychological tests assessing memory and executive functions than patients who received placebo or underwent Problem Solving Therapy . DESIGN R and omized trial . SETTING Stroke center . PARTICIPANTS One hundred twenty-nine patients were treated within 3 months following stroke . The 12-month trial included 3 arms : a double-blind placebo-controlled comparison of escitalopram ( n = 43 ) with placebo ( n = 45 ) , and a nonblinded arm of Problem Solving Therapy ( n = 41 ) . OUTCOME MEASURES Change in scores from baseline to the end of treatment for the Repeatable Battery for the Assessment of Neuropsychological Status ( RBANS ) and Trail-Making , Controlled Oral Word Association , Wechsler Adult Intelligence Scale-III Similarities , and Stroop tests . RESULTS We found a difference among the 3 treatment groups in change in RBANS total score ( P RBANS delayed memory score ( P escitalopram treatment on the change in RBANS total score ( P in RBANS delayed memory score ( P neuropsychological measures . CONCLUSIONS When compared with patients who received placebo or underwent Problem Solving Therapy , stroke patients who received escitalopram showed improvement in global cognitive functioning , specifically in verbal and visual memory functions . This beneficial effect of escitalopram was independent of its effect on depression . The utility of antidepressants in the process of poststroke recovery should be further investigated . Trial Registration clinical trials.gov Identifier : NCT00071643",
"OBJECTIVES To analyze the effects of antidepressants on cognitive functioning in elderly depression . METHODS Data were pooled for elderly participants with major depression from two double-blind 12-week studies ( n = 444 ) comparing sertraline to fluoxetine and to nortriptyline . A cognitive battery was performed pre-treatment and post-treatment that included the Shopping List Task ( SLT ) , which quantifies short-term and long-term memory storage and retrieval , and the Digit Symbol Substitution Test ( DSST ) , which measures visual tracking , motor performance , and coding . RESULTS Older age , male gender , higher systolic blood pressure , and higher illness severity were associated with lower performance on specific cognitive measures at baseline . For the entire group , improved depression and a lower anticholinergic side effect ( dry mouth and constipation ) severity were associated with statistically significant improvement in the SLT and DSST . The correlations between improvements in depression and improvement in tested cognitive function were highest for sertraline followed by nortriptyline and then fluoxetine . CONCLUSIONS Acute improvement in depression is associated with cognitive improvement as measured by the SLT and DSST . Prospect i ve studies are warranted to study the effects of potential differences among antidepressant therapies on long-term cognitive outcomes in geriatric depression",
"Previous research demonstrated that depression is associated with hyperactivity of the hypothalamus-pituitary-adrenocortical ( HPA ) system after stimulation . There is also strong evidence that the modulation of corticosteroids in the brain induces memory dysfunction which represents core features of depression . Antidepressant treatment with serotonin reuptake inhibitors ( SSRIs ) alleviates both dysfunctions . Thus , these previous observations propose a correlation between treatment induced changes of the endocrinological response of the HPA system to challenge with dexamethasone and CRH and changes of memory functions during antidepressant treatment . This study explores the relationship between depression , memory functions and the responsiveness of the HPA system as assessed by the combined DEX/CRH test during antidepressant treatment in n = 64 patients with major depression during a four weeks treatment with citalopram . We found that treatment induced changes of the cortisol response pattern in the DEX/CRH test were correlated with improvement of working memory but not so with episodic memory , sustained attention or global severity of depression . We suggest that improvement of working memory is more sensitive to the changes of hormones of the HPA system ( e.g. cortisol ) than other cognitive functions and the global severity of depression",
"BACKGROUND AND OBJECTIVES Cognitive and Behavioural Therapy ( CBT ) is widely used in bipolar disorder , but recent meta-analyses showed that its impact is either of limited effect or not significant for important aspects such as recurrence rate . A possible benefit of CBT could concern cognitive functions , known to be frequently impaired in patients with bipolar disorder . We analysed if the positive impact of 6 months group-CBT was associated with the improvement of a specific cognitive function , namely explicit memory , trying to disentangle if memory bias ( i.e. different capacity according to the emotional valence of words to be recalled ) was more improved than memory performance ( i.e. , total number of recalled words ) . METHODS Depressive , manic , anxiety symptoms and explicit memory for emotional words were initially assessed in 68 remitted bipolar I patients . Six months later , with an attrition rate of 16.2 % , patients were re-assessed after CBT ( N = 42 ) or as control condition ( waiting list , N = 15 ) . The expected impact of CBT was assessed through the improvement in the Dysfunctional Attitudes Scale . RESULTS After CBT , an increase was observed for the number of neutral , positive and total words recalled , whereas the number of negative words recalled decreased . This increase was still significant when the improvement of dysfunctional attitudes and mood symptoms are taken into account . LIMITATIONS The small sample of control patients . CONCLUSIONS CBT was effective , as it improved dysfunctional attitudes and reduced remaining symptoms , but also , and independently , it improved explicit memory performance while reducing memory bias in favour of negative words",
"Bipolar disorder is characterized by recurrent episodes of depression and /or mania along with interepisodic mood symptoms that interfere with psychosocial functioning . Despite periods of symptomatic recovery , individuals with bipolar disorder often continue to experience impairments in psychosocial functioning , particularly occupational functioning . Two determinants of psychosocial functioning of euthymic ( neither fully depressed nor manic ) individuals with bipolar disorder are residual depressive symptoms and cognitive impairment ( i.e. , difficulties with executive functioning , attention , and memory ) . The present study explored whether a new cognitive remediation ( CR ) treatment design ed to treat residual depressive symptoms and , for the first time to the best of our knowledge , address cognitive impairment would be associated with improvement in psychosocial functioning in individuals with bipolar disorder . Following a neuropsychological and clinical assessment 18 individuals with DSM‐IV bipolar disorder were treated with 14 individual sessions of CR . Results indicated that at the end of treatment , as well as at the 3‐months follow‐up , patients showed lower residual depressive symptoms , and increased occupational , as well as overall psychosocial functioning . Pretreatment neuropsychological impairment predicted treatment response . Improvements in executive functioning were associated with improvements in occupational functioning . These findings suggest that treating residual depressive symptoms and cognitive impairment may be an avenue to improving occupational and overall functioning in individuals with bipolar disorder",
"OBJECTIVE To compare the efficacy of duloxetine with placebo on depression in elderly patients with major depressive disorder . DESIGN Multicenter , 24-week ( 12-week short-term and 12-week continuation ) , r and omized , placebo-controlled , double-blind trial . SETTING United States , France , Mexico , Puerto Rico . PARTICIPANTS Age 65 years or more with major depressive disorder diagnosis ( one or more previous episode ) ; Mini-Mental State Examination score ≥20 ; Montgomery-Asberg Depression Rating Scale total score ≥20 . INTERVENTION Duloxetine 60 or 120 mg/day or placebo ; placebo rescue possible . MEASUREMENTS Primary -Maier subscale of the 17-item Hamilton Depression Rating Scale ( HAMD-17 ) at week 12 . Secondary -Geriatric Depression Scale , HAMD-17 total score , cognitive measures , Brief Pain Inventory ( BPI ) , Numeric Rating Scales ( NRS ) for pain , Clinical Global Impression-Severity scale , Patient Global Impression of Improvement in acute phase and acute plus continuation phase of treatment . RESULTS Compared with placebo , duloxetine did not show significantly greater improvement from baseline on Maier subscale at 12 weeks , but did show significantly greater improvement at weeks 4 , 8 , 16 , and 20 . Similar patterns for Geriatric Depression Scale and Clinical Global Impression-Severity scale emerged , with significance also seen at week 24 . There was a significant treatment effect for all BPI items and 4 of 6 NRS pain measures in the acute phase , most BPI items and half of the NRS measures in the continuation phase . More duloxetine-treated patients completed the study ( 63 % versus 55 % ) . A significantly higher percentage of duloxetine-treated patients versus placebo discontinued due to adverse event ( 15.3 % versus 5.8 % ) . CONCLUSIONS Although the antidepressant efficacy of duloxetine was not confirmed by the primary outcome , several secondary measures at multiple time points suggested efficacy . Duloxetine had significant and meaningful beneficial effects on pain",
"Patients with major depressive disorder ( MDD ) usually suffer from altered cognitive functions of episodic memory , working memory , mental processing speed and motor response . Diverse studies suggest that different antidepressant agents may improve cognitive functions in patients with MDD . The aim of this work is to study the effects of serotonergic reuptake inhibitors ( SSRIs ) and serotonergic-noradrenergic reuptake inhibitors ( SNRIs ) treatments to improve the performance on memory tasks and mental processing speed in MDD . Seventy-three subjects meeting criteria for major depressive disorder were assessed with the Hamilton depression rating scale and a neuropsychological battery . The subjects were medicated with escitalopram ( n=36 ) or duloxetine ( n=37 ) for 24 weeks . At the end of the trial , the subjects were assessed again with the same neuropsychological battery used prior to the treatment . Both treatments improved importantly the episodic memory and to a lesser extent , working memory , mental processing speed and motor performance . Our results suggest that cognition is partially independent from improvement in clinical symptoms . Both groups achieved remission rates in the HAM-D-17 after 24 weeks of treatment , but SNRI was superior to SSRI at improving episodic and working memory . Our work indicates that the superiority of SNRI over the SSRI at episodic memory improvement is clinical ly relevant",
"BACKGROUND Despite increasing awareness of the extent and severity of cognitive deficits in major depressive disorder ( MDD ) , trials of cognitive remediation have not been conducted . We conducted a 10-week course of cognitive remediation in patients with long-term MDD to probe whether deficits in four targeted cognitive domains , ( i ) memory , ( ii ) attention , ( iii ) executive functioning and ( iv ) psychomotor speed , could be improved by this intervention . METHOD We administered a computerized cognitive retraining package ( PSSCogReHab ) with demonstrated efficacy to 12 stable patients with recurrent MDD . Twelve matched patients with MDD and a group of healthy control participants were included for comparison ; neither comparator group received the intervention that involved stimulation of cognitive functions through targeted , repetitive exercises in each domain . RESULTS Patients who received cognitive training improved on a range of neuropsychological tests targeting attention , verbal learning and memory , psychomotor speed and executive function . This improvement exceeded that observed over the same time period in a group of matched comparisons . There was no change in depressive symptom scores over the course of the trial , thus improvement in cognitive performance occurred independent of other illness variables . CONCLUSIONS These results provide preliminary evidence that improvement of cognitive functions through targeted , repetitive exercises is a viable method of cognitive remediation in patients with recurrent MDD",
"It has frequently been demonstrated that acute tryptophan depletion ( ATD ) induces a transient depressed mood in some patients who are in remission from depression . However , the effects of ATD on cognitive processes in remitted depressed patients have not been investigated . The aim of the present study was to investigate the effects of different extents of depletion on mood and cognitive tasks involving neutral and emotional stimuli . Twenty patients in remission or in partial remission from depression received ATD in a double-blind , crossover design . Mood was assessed at both sessions before , at + 6.5 h and + 24 h afterdepletion . Cognitive assessment in both sessions started at + 4.75 h , and also before and after the whole procedure . The ATD mixtures induced the expected reductions of plasma tryptophan levels . High-dose ATD induced a depressive response in a sub sample of patients and impaired theprocessing of positive information independent of mood change . Attention for neutral stimuli ( Stroop interference ) improved in a dose-dependent manner . ATD may affect mood and cognition via different pathways : one implicated in mood regulation and the processing ofemotional information , and one for the processing of neutral information . The first pathway may be more important for discriminating vulnerability to impaired serotonin function . The comparison of the effects of high-dose and low-dose ATD is useful for those studies aim ing to investigate the relationships among 5-HT , mood and cognition",
"1 . Depression is frequent in the elderly but difficult both to diagnose and treat due to a number of distinctive features . 2 . Tianeptine is a novel antidepressant with a reverse mode of action to that of the selective serotonin reuptake inhibitors yet with proven efficacy and safety . 3 . 63 elderly patients ( mean age:68.8 years ; range:65 - 80 years ) with depressive symptoms ( major depression:55.6 % ; dysthymia:44.4 % ) were included in a 3-month open multicenter study with tianeptine ( 25 mg daily ) . 4 . 43 patients ( 68.2 % ) completed the study . There were no drop-outs due to side-effects . Total Montgomery and Asberg Depression Rating Scale scores were significantly decreased ( p anxiety and cognitive performance . Side-effects were seen in only 11.7 % of patients , with no changes in laboratory or ancillary safety parameters . Tianeptine is thus effective and well tolerated in this category of patient",
"OBJECTIVE Cognitive remediation is an efficacious treatment for schizophrenia and , when used within broader psychosocial treatments , improves transfer to real-world behavior change . The authors examined whether cognitive remediation effectively generalizes to functional competence and real-world functioning as a st and alone treatment and when combined with a functional skills treatment . METHOD Out patients with schizophrenia ( N=107 ) were r and omly assigned to receive cognitive remediation , functional adaptation skills training , or combined treatment , with cognitive remediation preceding functional skills training . Clinical symptoms , neurocognition , social competence , functional competence , and case-manager-rated real-world behavior were assessed at baseline , at end of treatment , and at a 12-week durability assessment . RESULTS Neurocognition improved , with durable effects , after cognitive remediation but not after functional skills training . Social competence improved both with functional skills training and with combined treatment but not with cognitive remediation alone . Improvements in functional competence were greater and more durable with combined treatment . Cognitive remediation alone did not produce significant improvements in real-world behavior , but when combined with functional skills training , statistically significant improvements from baseline to end of treatment and follow-up were observed in community or household activities and work skills . Number-needed-to-treat analyses suggest that as few as three cases are required for treatment to induce a meaningful improvement in functional skills . CONCLUSIONS In a short intervention , cognitive remediation produced robust improvements in neurocognition . Generalization to functional competence and real-world behavior was more likely when supplemental skills training and cognitive remediation were combined",
"OBJECTIVE Depression in older adults is often associated with cognitive abnormalities and may predict later development of a primary cognitive disorder . This double-blind , r and omized , placebo-controlled pilot study was design ed to assess the safety and efficacy of galantamine augmentation of antidepressant treatment for depressive and cognitive symptoms in older adults with major depression . METHODS Thirty-eight , non-demented older adults ( age > 50 ) with major depression were r and omized to receive galantamine or placebo augmentation of st and ard antidepressant pharmacotherapy ( venlafaxine XR or citalopram ) . Mood and cognitive status were monitored for 24 weeks using the 24-item Hamilton Rating Scale for Depression and the Repeatable Battery for the Assessment of Neuropsychological Status . RESULTS Both groups showed significant improvements in mood and cognition over 24 weeks , but no significant difference was found in change over time between groups . An exploratory post-hoc analysis suggested that patients r and omized to galantamine had lower depression scores compared to patients in the placebo group after 2 weeks of treatment . Dropout was high with more subjects r and omized to antidepressant plus galantamine withdrawing early from the study . CONCLUSIONS This pilot study failed to demonstrate a benefit for galantamine augmentation of antidepressant medication in the treatment of depression in older adults . Future studies should explore strategies for reducing dropout in such longitudinal trials and more carefully assess time to response with cholinesterase inhibitor augmentation",
"OBJECTIVE Knowledge of the relationship between various clinical characteristics and cognitive functioning is advancing , but little is known about the cognitive response to treatment for geriatric depression . The purpose of this study was to examine the cognitive response to treatment for patients with late-life depression . METHOD Subjects included 45 nondemented , elderly depressed patients who achieved remission after 12 weeks of antidepressant treatment and 20 elderly comparison subjects . All subjects were administered a battery of clinical measures , including cognitive screening instruments , before and after treatment . RESULTS As a group , the elderly depressed patients showed a small improvement in overall cognitive functioning after treatment . Among depressed patients with concomitant cognitive impairment at baseline , performance on the Mattis Dementia Rating Scale domains of conceptualization and initiation/perseveration improved significantly relative to those of depressed patients with normal cognition . Despite the improvement following treatment , the overall level of cognitive functioning in the elderly depressed patients with cognitive impairment at baseline remained mildly impaired , especially in the memory and initiation/perseveration domains . CONCLUSIONS Elderly depressed patients with cognitive impairment may experience improvement in specific domains following antidepressant treatment but may not necessarily reach normal levels of performance , particularly in memory and executive functions . This subgroup of late-life depression patients is likely at high risk of developing progressive dementia",
"OBJECTIVE This study compared the effects of duloxetine , 60 mg/day , versus placebo on cognition , depression , and pain in elderly patients with recurrent major depressive disorder . METHOD Patients were r and omly assigned ( 2:1 ) to duloxetine , 60 mg/day ( N=207 ) , or placebo ( N=104 ) for 8 weeks in a double-blind study . The primary outcome measure was a prespecified composite cognitive score composed of four individual tests . Secondary measures included the Geriatric Depression Scale , the Hamilton Depression Rating Scale , the Visual Analogue Scale assessing pain , and st and ard safety and tolerability assessment s. RESULTS Patients had a median age of 72 years ( range=65 - 90 ) . Duloxetine demonstrated significantly greater improvement in the composite cognitive score versus placebo ( least-squares mean change from baseline to endpoint : 1.95 versus 0.76 ) , driven by improved verbal learning and memory . Duloxetine treatment showed significantly greater baseline-to-endpoint reductions in both Hamilton depression scale ( -6.49 versus -3.72 ) and Geriatric Depression Scale ( -4.07 versus -1.34 ) total scores compared with placebo . Hamilton depression scale response ( 37.3 % versus 18.6 % ) and remission ( 27.4 % versus 14.7 % ) rates at endpoint were significantly higher for duloxetine than for placebo . Duloxetine significantly improved Visual Analogue Scale scores for back pain and time in pain while awake versus placebo . Significantly fewer patients receiving duloxetine withdrew from the study because of lack of efficacy ( 2.9 % versus 9.6 % ) ; the incidences of discontinuation due to adverse events were similar for duloxetine and placebo ( 9.7 % versus 8.7 % ) . CONCLUSIONS Duloxetine improved cognition , depression , and some pain measures and was safe and well tolerated in elderly patients with recurrent major depressive disorder",
"OBJECTIVE This study was design ed to evaluate the comparative efficacy and safety of sertraline and nortriptyline for the treatment of major depressive disorder in older adults . METHOD A double-blind , parallel group design was used to compare 210 out patients , 60 years of age and older , who met DSM-III-R criteria for major depressive episode and had a minimum Hamilton Depression Rating Scale score of 18 . The patients were r and omly assigned to 12 weeks of treatment with either sertraline ( 50 - 150 mg/day ) or nortriptyline ( 25 - 100 mg/day ) . RESULTS The safety profiles of the two treatments were similar except that nortriptyline treatment was associated with a significant increase in pulse rate , whereas sertraline was associated with a nonsignificant decrease . Efficacy of both drugs was similar for both treatments at all time points , with 71.6 % ( N=53 of 74 ) of the sertraline-treated patients and 61.4 % ( N=43 of 70 ) of the nortriptyline-treated patients achieving responder status by week 12 . Time to response was also similar , with more than 75 % of the improvement in scores on the Hamilton depression scale having occurred by week 6 . Secondary efficacy measures ( posttreatment measures of cognitive function , memory , and quality of life ) revealed a significant advantage for sertraline treatment . CONCLUSIONS Primary efficacy measures showed sertraline and nortriptyline to be similarly effective . With secondary outcome measures there was consistent evidence of an advantage for the sertraline-treated group . The clinical impact of these measures on the long-term well-being of elderly depressed patients should be examined in a study of maintenance treatment",
"BACKGROUND Maternal depression is associated with abnormal processing of infant distress . This may explain why depression disrupts maternal behaviour and ultimately child outcomes . Underst and ing and improving such processing , in depressed mothers as early as possible is thus important . AIM The focus of the current study was to investigate whether Cognitive Behavioural Therapy ( CBT ) normalises depressed pregnant women 's abnormal attentional processing of infant distress . METHOD Depressed pregnant women participating in a r and omised control trial completed a measure of attentional bias for infant distress before and after intervention . Women received either CBT ( n=12 ) or usual care [ UC ] ( n=12 ) between their first and last trimesters of pregnancy . RESULTS At baseline , depressed women in both arms showed a diminished attentional bias for infant distress compared to a non-depressed comparison group ( n=51 ) . Following intervention attentional biases of women who received CBT increased becoming comparable to non-depressed women . In contrast there was no improvement in the UC arm . CONCLUSIONS If replicated , the findings may suggest that CBT during pregnancy improves mother 's basic processing of infant stimuli before their child is born . LIMITATIONS The sample size was relatively small and there was some loss to follow up between the pre and post intervention sessions",
"Objective : To determine whether augmenting work therapy ( WT ) with neurocognitive enhancement therapy ( NET ) yields greater improvement in working memory performance than WT alone and whether there is an interaction with severity of impairment",
"The efficacy and tolerability of Lu AA21004 at 5 mg/day , a novel multimodal antidepressant , were assessed in elderly patients with recurrent major depressive disorder . Patients were r and omly assigned ( 1 : 1 : 1 ) to Lu AA21004 5 mg/day , duloxetine 60 mg/day ( reference ) or to placebo in an 8-week double-blind study . The primary efficacy measure was the 24-item Hamilton Depression Scale ( HAM-D24 ) total score ( analysis of covariance , last observation carried forward ) . Patients ( mean age 70.6 years ) had a mean baseline HAM-D24 score of 29.0 . Lu AA21004 showed significantly ( P=0.0011 ) greater improvement on the primary efficacy endpoint compared with placebo at week 8 ( 3.3 points ) . Duloxetine also showed superiority to placebo at week 8 , thereby validating the study . HAM-D24 response ( 53.2 vs. 35.2 % ) and HAM-D17 remission ( 29.2 vs. 19.3 % ) rates at endpoint were higher for Lu AA21004 than for placebo . Lu AA21004 showed superiority to placebo in cognition tests of speed of processing , verbal learning and memory . The withdrawal rate due to adverse events was 5.8 % ( Lu AA21004 ) , 9.9 % ( duloxetine ) and 2.8 % ( placebo ) . Whereas nausea was the only adverse event with a significantly higher incidence on treatment with Lu AA21004 ( 21.8 % ) compared with placebo ( 8.3 % ) , the incidence of nausea , constipation , dry mouth , hyperhidrosis and somnolence was higher for duloxetine . In conclusion , Lu AA21004 was efficacious and well tolerated in the treatment of elderly patients with recurrent major depressive disorder",
"OBJECTIVE To assess combined antidepressant and cognitive enhancer treatment in elderly patients presenting with depression plus cognitive impairment . METHODS Twenty-three elderly ( > 50 years old ) depressed , cognitively impaired ( DEP-CI ) patients participated in a pilot study . We evaluated whether , after 8 weeks of open antidepressant treatment , donepezil HCl ( Aricept ) would afford added cognitive benefit compared to placebo in a r and omized 12-week trial . A sub sample continued in an 8-month extension phase of open treatment with donepezil . Neuropsychological testing ( NPT ) was performed and antidepressant response monitored at baseline and the 8 , 20 , and 52-week time points . RESULTS At 8-weeks , the antidepressant response rate was 61 % ( 14/23 ) . Improvement in SRT immediate recall ( SRT-IR ; e.g. episodic verbal memory ) was observed in responders compared to non-responders . During the 12-week , placebo-controlled , donepezil add-on trial , patients on donepezil showed further improvement in SRT-IR versus patients on placebo . In the open extension phase , patients who continued open donepezil treatment ( n = 6 ) maintained improvement in memory and tended to show an advantage over patients who never received donepezil and were evaluated at the 52-week time point ( n = 6 ) . There were no observed significant donepezil effects on non-memory cognitive domains . CONCLUSION These preliminary findings suggest that addition of a cholinesterase inhibitor ( AChEI ) following antidepressant medication treatment in elderly Dep-CI patients may improve cognition , and support the need for a confirmatory , larger r and omized placebo-controlled trial",
"BACKGROUND Neuropsychological deficits in depression include difficulties with psychomotor speed , executive functions and memory . Some of these changes persist despite antidepressant treatment . While research in other areas of psychiatry has shown cognitive training techniques to be effective , only one study has evaluated this approach in depression . METHODS Sixteen patients ( mean age=33.5years ) with a lifetime diagnosis of major depressive disorder were administered a st and ardised battery of neuropsychological tests and allocated to treatment ( n=8 ) or waitlist control ( n=8 ) conditions . The treatment consisted of 10-weeks of twice weekly cognitive training using the Neuropsychological Educational Approach to Remediation . All participants were re-assessed after 10-weeks by interviewers blinded to group allocation . RESULTS Participants in the treatment condition demonstrated greater improvements on tests of memory encoding and memory retention than the waitlist control group . There were no observable benefits in terms of psychomotor speed or executive functions or in self-reported levels of disability . Affective symptoms also remained stable . LIMITATIONS This study included a small sample of participants and treatment allocation was not r and omised . CONCLUSIONS Cognitive training in affective disorders improves memory performance . It may be an effective non-pharmacological treatment option for improving cognitive functions , which in turn , may improve psychosocial functioning and reduce disability . This study supports theories suggesting cognitive training may promote neuroplasticity",
"BACKGROUND Cognitive behavioral therapy ( CBT ) is an effective treatment for emotional disorders such as anxiety or depression , but the mechanisms underlying successful intervention are far from understood . Although it has been a long-held view that psychopharmacological approaches work by directly targeting automatic emotional information processing in the brain , it is usually postulated that psychological treatments affect these processes only over time , through changes in more conscious thought cycles . This study explored the role of early changes in emotional information processing in CBT action . METHODS Twenty-eight untreated patients with panic disorder were r and omized to a single session of exposure-based CBT or waiting group . Emotional information processing was measured on the day after intervention with an attentional visual probe task , and clinical symptoms were assessed on the day after intervention and at 4-week follow-up . RESULTS Vigilance for threat information was decreased in the treated group , compared with the waiting group , the day after intervention , before reductions in clinical symptoms . The magnitude of this early effect on threat vigilance predicted therapeutic response after 4 weeks . CONCLUSIONS Cognitive behavioral therapy rapidly affects automatic processing , and these early effects are predictive of later therapeutic change . Such results suggest very fast action on automatic processes mediating threat sensitivity , and they provide an early marker of treatment response . Furthermore , these findings challenge the notion that psychological treatments work directly on conscious thought processes before automatic information processing and imply a greater similarity between early effects of pharmacological and psychological treatments for anxiety than previously thought",
"OBJECTIVES The present study was design ed to evaluate the effect of twelve weekly sessions of the cognitive-behavioral program originally known as the Integriertes Psychologisches Therapieprogramm für Schizophrene Patienten , design ated the Integrated Psychological Therapy ( IPT ) program in English , on cognition , social adjustment and quality of life in schizophrenic out patients , comparing it to the effect of treating such patients as usual . METHOD Fifty-six adult out patients ( from 18 to 65 years of age ) with ICD-10-based diagnoses of schizophrenia were r and omly assigned to two different groups : active intervention ( IPT group ) ; and treatment as usual ( control group ) . Outcome measures were quality of life ( as determined using the WHOQOL-Bref ) , cognition ( Mini-Mental State Examination and Word Recall Test ) , global functioning ( DSM-IV Global Assessment of Functioning Scale ) , social functioning ( Social and Occupational Functioning Assessment Scale ) and social adjustment ( Social Adjustment Scale ) . RESULTS The findings suggest that , in comparison with treatment as usual ( control group ) , the twelve-session IPT program had a positive effect on several outcome measures : cognition in the domains of spatiotemporal orientation ( p = 0.051 ) and memory ( p = 0.031 ) ; overall social adjustment ( p = 0.037 ) , leisure/social life ( p = 0.051 ) and family relations ( p = 0.008 ) ; overall functioning ( p = 0.000 ) ; social-occupational functioning ( p = 0.000 ) ; and quality of life in the psychological domain ( p = 0.021 ) . CONCLUSIONS The twelve-session cognitive-behavioral IPT intervention demonstrated superiority over treatment as usual in its effects on cognition , social adjustment and quality of life . Studies involving larger sample s , longer follow-up periods and additional outcome measures are needed in order to assess the specific effects on dimensions of social functioning , cognitive functioning and quality of life in patients with schizophrenia",
"OBJECTIVE Return of functional ability is a central goal in the treatment of major depressive disorder . We conducted two trials with the same protocol that was design ed to assess functioning after 8 Weeks of treatment with duloxetine . METHODS The a priori primary outcome was improvement in the Hamilton Depression Rating Scale ( HAMD ) item 7 ( work/activities ) . Secondary outcomes included improvement in depressive symptoms assessed by the HAMD Maier subscale , and improvement in functioning assessed by the Sheehan Disability Scale ( SDS ) , and the Social Adaptation Self-evaluation Scale ( SASS ) . Patients were r and omly assigned to duloxetine 60 mg/day ( Trial I , n = 257 ; Trial II , n = 261 ) or placebo ( Trial I , n = 127 ; Trial II , n = 131 ) . Changes from baseline were analyzed using a mixed-effects model repeated measures approach . RESULTS At Week 8 , duloxetine was superior to placebo in improving HAMD work/activities ( p Maier scores ( p duloxetine was superior to placebo on improving SASS scores in both trials , and the SDS in Trial II . CONCLUSION Treatment with duloxetine was associated with significant improvement in depressive symptoms compared with placebo , but improvement in HAMD work/activities was inconsistent at 8 weeks",
"BACKGROUND Major depressive disorder ( MDD ) is often accompanied by significant cognitive impairment , and there are limited interventions specific to this particular symptom . S-adenosyl methionine ( SAMe ) , a naturally occurring molecule which serves as a major methyl-donor in human cellular metabolism , is required for the synthesis and maintenance of several neurotransmitters that have been implicated in the pathophysiology and treatment of cognitive dysfunction in MDD . METHODS This study is a secondary analysis of a clinical trial involving the use of adjunctive SAMe for MDD . Forty-six serotonin-reuptake inhibitor ( SRI ) non-responders with MDD enrolled in a 6-week , double-blind , r and omized trial of adjunctive oral SAMe were administered the self-rated cognitive and physical symptoms question naire ( CPFQ ) , a vali date d measure of cognitive as well as physical symptoms of MDD , before and after treatment . RESULTS There was a greater improvement in the ability to recall information ( p=0.04 ) and a trend toward statistical significance for greater improvement in word-finding ( p=0.09 ) for patients who received adjunctive SAMe than placebo . None of the remaining five items reached statistical significance . CONCLUSION These preliminary data suggest that SAMe can improve memory-related cognitive symptoms in depressed patients , and warrant replication",
"BACKGROUND Cognitive deficits have been described in patients with major depression ( MD ) , although many aspects remain unsettled . METHOD During an episode of MD and after remission we used tasks exploring attention , implicit , antero grade and retro grade memory to investigate 48 drug-free patients aged over 50 years without dementia , comparing them with 15 normal volunteer controls ( NC ) . We also evaluated the effect of antidepressant therapy ( ADT ) with fluoxetine ( F ) or reboxetine ( R ) at baseline ( T0 ) and six months later ( T6 ) . RESULTS 42 patients completed the study and 6 dropped out ; 33 patients were considered \" Remitters \" ( RP ) ( 17 F pts and 16 R pts ) . At T0 , the entire group of MD patients ( MDP ) had worse performances than NC in Mini Mental Status Examination ( MMSE ) , Wechsler Memory Scale ( WMS ) total score ( TS ) , in a few subtests of WMS and in autobiographical memory . RP at T0 had the same impaired tasks and at T6 had significantly improved in MMSE , WMS . TS and many memory tests but they still differed from NC in a few complex tasks requiring more cognitive effort . LIMITATIONS The effects and differences between F and R must be viewed with caution considering the relatively small sample ; only attention and memory were investigated . CONCLUSIONS Our findings confirm a negative effect of depression on memory with a significant but incomplete improvement after remission and without differences between F and R. We speculate that both a \" state \" and a \" trait \" depressive component underlie this memory impairment"
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Background Nonalcoholic fatty liver disease ( NAFLD ) is the most prevalent chronic liver disease worldwide . The pathogenesis of NAFLD is complex and multifactorial . There is growing evidence that altered gut microbiota plays a key role in NAFLD progression . Probiotics/synbiotics , by modifying gut microbiota , may be a promising treatment choice for NAFLD management . Aim The aim of this study was to study the effect of probiotics/synbiotics on various laboratory and radiographic parameters in NAFLD management . Material s and methods A systematic review and meta- analysis were carried out according to Preferred Reporting Items for Systematic Review s and Meta-analyses guidelines . We search ed PubMed , Medline , and Google Scholar for r and omized-controlled trials that studied the role of probiotics/synbiotics in NAFLD . The primary outcome was change in baseline alanine aminotransferase and aspartate aminotransferase in the treatment arm . We used a r and om-effects model and inverse variance for the continuous data to estimate the mean difference ( MD ) and the st and ard mean difference ( SMD ) in RevMan Version 5.3 . Results We included 12 r and omized-controlled trials for analysis . The intervention arm , which comprised of the probiotic and /or the synbiotic arm , showed a significant improvement in alanine aminotransferase levels , MD=–13.93 , confidence interval (CI)=–20.20 to –7.66 , P value of less than 0.0001 , I2=92 % and aspartate aminotransferase levels MD=−11.45 , CI=−15.15 to −7.74 , P value of less than 0.00001 , I2=91 % . There was a reduction in high-sensitivity C-reactive protein levels in the intervention arm , SMD=–0.68 , CI=–1.10 to –0.26 , P value of 0.001 , I2=0 % . The liver fibrosis score improved in the intervention arm , MD=–0.71 , CI=–0.81 to –0.61 , P value less than 0.00001 , I2=0 % . Conclusion Probiotic/synbiotic use improves aminotransaminase levels and reduces proinflammatory marker high-sensitivity C-reactive protein and liver fibrosis in NAFLD patients
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"Background Increased exposure to intestinal bacterial products may contribute to the pathogenesis of non alcoholic steatohepatitis ( NASH ) . Bifidobacteria are predominant bacterial species in the human gut microbiota and have been considered to exert a beneficial effect on human health by maintaining the equilibrium of the resident microbiota . Aims To evaluate the effects of Bifidobacterium longum with fructo-oligosaccharides ( Fos ) in the treatment of NASH . Methods A total of 66 patients were r and omly and equally divided into two groups receiving Bifidobacterium longum with Fos and lifestyle modification ( i.e. , diet and exercise ) versus lifestyle modification alone . The following variables were assessed at −4 ( beginning of the dietary lead-in period ) , 0 ( r and omization ) , 6 , 12 , 18 , and 24 weeks : aspartate transaminase ( AST ) , alanine transaminase ( ALT ) , bilirubin , albumin , total cholesterol , high-density lipoprotein ( HDL ) cholesterol , low-density lipoprotein ( LDL ) cholesterol , triglycerides , fasting plasma glucose , insulin , C-peptide , C-reactive protein ( CRP ) , tumor necrosis factor (TNF)-α , homeostasis model assessment of insulin resistance ( HOMA-IR ) , and serum endotoxins . Liver biopsies were performed at entry and repeated after 24 weeks of treatment . Results At the end of study period , we observed that the Bifidobacterium longum with Fos and lifestyle modification group versus the lifestyle modification alone group showed significant differences in the AST −69.6 versus −45.9 IU/mL ( P LDL cholesterol −0.84 versus −0.18 mmol/L ( P ) , HOMA-IR −1.1 versus −0.6 ( P serum endotoxin −45.2 versus −30.6 pg/mL ( P steatosis ( P , and the NASH activity index ( P 0.05 ) . Conclusions Bifidobacterium longum with Fos and lifestyle modification , when compared to lifestyle modification alone , significantly reduces TNF-α , CRP , serum AST levels , HOMA-IR , serum endotoxin , steatosis , and the NASH activity index ",
"BACKGROUND Probiotics have a beneficial effect on nonalcoholic fatty liver disease ( NAFLD ) in animal models . R and omized placebo-controlled trials ( RCTs ) in NAFLD are still lacking in humans despite a large number of data from animal research . AIM We performed a double-blind single center RCT of live multi-strain probiotic vs. placebo in type 2 diabetes patients with NAFLD . METHODS A total of 58 patients met the criteria for inclusion . They were r and omly assigned to receive the multi-probiotic \" Symbiter \" ( concentrated biomass of 14 probiotic bacteria genera Bifidobacterium , Lactobacillus , Lactococcus , Propionibacterium ) or placebo for 8-weeks administered as a sachet formulation in double-blind treatment . The primary main outcomes were the changes in fatty liver index ( FLI ) and liver stiffness ( LS ) measured by Shear Wave Elastography ( SWE ) . Secondary outcomes were the changes in aminotransferase activity , serum lipids and cytokines ( TNF-α , IL-1β , IL-6 , IL-8 , and IFN-γ ) levels . Analysis of covariance was used to assess the difference between groups . RESULTS In the probiotic group , FLI significantly decreased from 84.33+/-2.23 to 78.73+/-2.58 ( p reduction of LS measured by SWE was detected . Analysis of the secondary outcomes showed that probiotics reduced the level of serum AST and GGT . Among the markers of chronic systemic inflammatory state , only TNF-α and IL-6 levels changed significantly after the treatment with the probiotic . CONCLUSION The probiotic \" Symbiter \" reduces liver fat , aminotransferase activity , and the TNF-α and IL-6 levels in NAFLD patients . Modulation of the gut microbiota might represent a new therapy for NAFLD , which should be tested in larger studies",
"BACKGROUND Nonalcoholic fatty liver disease ( NAFLD ) is the most common chronic liver disease in the world . Oral administration of synbiotic has been proposed as an effective treatment of NAFLD because of its modulating effect on the gut flora , which can influence the gut-liver axis . OBJECTIVE The objective was to evaluate the effects of supplementation with synbiotic on hepatic fibrosis , liver enzymes , and inflammatory markers in patients with NAFLD . DESIGN In a r and omized , double-blind , placebo-controlled clinical trial conducted as a pilot study , 52 patients with NAFLD were supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule . Both groups were advised to follow an energy-balanced diet and physical activity recommendations . RESULTS At the end of the study , the alanine aminotransferase ( ALT ) concentration decreased in both groups ; this reduction was significantly greater in the synbiotic group . At the end of the study , the following significant differences [ means ( 95 % CIs ) ] were seen between the synbiotic and placebo groups , respectively : ALT [ -25.1 ( -26.2 , -24 ) compared with -7.29 ( -9.5 , -5.1 ) IU/L ; P 0.001 ] , aspartate aminotransferase [ -31.33 ( -32.1 , -30.5 ) compared with -7.94 ( -11.1 , -4.8 ) IU/L ; P ] , γ-glutamyltransferase [ -15.08 ( -15.5 , -14.7 ) compared with -5.21 ( -6.6 , -3.9 ) IU/L ; P protein [ -2.3 ( -3 , -1.5 ) compared with -1.04 ( -1.5 , -0.6 ) mmol/L ; P 0.05 ] , tumor necrosis factor-α [ -1.4 ( -1.7 , -1.1 ) compared with -0.59 ( -0.8 , -0.3 ) mmol/L ; P p65 [ -0.016 ( -0.022 , -0.011 ) compared with 0.001 ( -0.004 , -0.007 ) mmol/L ; P score as determined by transient elastography [ - 2.98 ( -3.6 , -2.37 ) compared with -0.77 ( -1.32 , -0.22 ) kPa ; P CONCLUSIONS Synbiotic supplementation in addition to lifestyle modification is superior to lifestyle modification alone for the treatment of NAFLD , at least partially through attenuation of inflammatory markers in the body . Whether these effects will be sustained with longer treatment duration s remains to be determined",
"Non-alcoholic fatty liver disease ( NAFLD ) has been suggested to be well correlated with altered blood pressure . This study was conducted to determine the effects of symbiotic and vitamin E supplementation on blood pressure and inflammatory indices of patients with NAFLD . This r and omized , double-blind , placebo-controlled trial was performed among 60 NAFLD patients aged 25 to 64 years old . Participants were r and omly divided into four groups to receive a 400 IU alpha-tocopherol and 2 × 108 CFU/g symbiotic supplement for 8 weeks . The anthropometric parameters , systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) , serum malondialdehyde ( MDA ) , nitric oxide ( NO ) and tumor necrosis factor α ( TNFα ) were assessed at baseline and after 8 weeks of intervention . After 8 weeks of intervention , combined symbiotic and alpha-tocopherol , symbiotic and alpha-tocopherol alone administration , compared with the placebo , result ed in significant decreases in SBP ( -17.07±2.1 , -16.07±3.56 , -1.73±2.25 and -1.55±3.01 mmHg , P=0.01 ) , serum MDA ( -1.19±0.5 , -0.12±0.65 , 0.14 ± 0.64 and 0.16±0.34 nmol/mL , P ) , serum TNFα ( -15.62±13.93 , -9.24±7.12 , -11.44 ± 15.47 and 3.01±1.71 pg/ml , P concentrations . A significant decrease in serum AST ( -11.36±4.52 , -7.43±8.58 , -5.93±6.61 and 2.5±5.75 μmol/L , P , ALT ( -12.79±3.65 , -3.66±6.81 , -6.54±7.66 and 4.16±3.43 μmol/L , P ALP ( -26.8±11.1 , -4.56±9.22 , -14.48±12.22 and 5.19±2.64 μmol/L , P NO concentration were not significant . Alpha-tocopherol and symbiotic supplementation among patients with NAFLD result ed in decreased SBP , serum MDA , TNFα levels and enzymes liver ; however , they did not affect DBP and serum NO concentration ",
"Nonalcoholic fatty liver disease is the most prevalent chronic liver disease in Western countries ; it can progress to nonalcoholic steatohepatitis ( NASH ) , cirrhosis and hepatocarcinoma . The importance of gut-liver-adipose tissue axis has become evident and treatments targeting gut microbiota may improve inflammatory and metabolic parameters in NASH patients . In a r and omized , controlled clinical trial , involving 50 biopsy-proven NASH patients , we investigated the effects of synbiotic supplementation on metabolic parameters , hepatic steatosis , intestinal permeability , small intestinal bacterial overgrowth ( SIBO ) and lipopolysaccharide ( LPS ) serum levels . Patients were separated into two groups receiving Lactobacillus reuteri with guar gum and inulin for three months and healthy balanced nutritional counseling versus nutritional counseling alone . Before and after the intervention we assessed steatosis by magnetic resonance imaging , intestinal permeability by lactulose/mannitol urinary excretion and SIBO by glucose breath testing . NASH patients presented high gut permeability , but low prevalence of SIBO . After the intervention , only the synbiotic group presented a reduction in steatosis , lost weight , diminished BMI and waist circumference measurement . Synbiotic did not improve intestinal permeability or LPS levels . We concluded that synbiotic supplementation associated with nutritional counseling seems superior to nutritional counseling alone for NASH treatment as it attenuates steatosis and may help to achieve weight loss",
"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 Probiotics have profound effect on nonalcoholic steatohepatitis ( NASH ) in animal models . We aim ed to test the hypothesis that probiotics treatment was superior to usual care in reducing liver fat in NASH patients . MATERIAL AND METHODS Patients with histology-proven NASH were r and omized to receive probiotics ( n = 10 ) or usual care ( n = 10 ) for 6 months . The Lepicol probiotic formula contained Lactobacillus plantarum , Lactobacillus deslbrueckii , Lactobacillus acidophilus , Lactobacillus rhamnosus and Bifidobacterium bifidum . The primary endpoint was change in intrahepatic triglyceride content ( IHTG ) , as measured by proton-magnetic resonance spectroscopy , from baseline to month 6 . Secondary endpoints included changes in liver biochemistry and metabolic profile . RESULTS IHTG decreased from 22.6 ± 8.2 % to 14.9 ± 7.0 % in the probiotic group ( P = 0.034 ) but remained static in the usual care group ( 16.9 ± 6.1 % to 16.0 ± 6.6 % ; P = 0.55 ) . Six subjects in the probiotic group had IHTG reduced by more than 30 % from baseline , compared to 2 subjects in the usual care group ( P = 0.17 ) . The probiotic group also had greater reduction in serum aspartate aminotransferase level ( P = 0.008 ) . On the other h and , the use of probiotics was not associated with changes in body mass index , waist circumference , glucose and lipid levels . CONCLUSIONS Probiotics treatment may reduce liver fat and AST level in NASH patients . The therapeutic potential of probiotics in NASH should be tested in larger studies",
"BACKGROUND & AIMS Prevalence of nonalcoholic fatty liver disease ( NAFLD ) has not been well established . The purpose of this study was to prospect ively define the prevalence of both NAFLD and nonalcoholic steatohepatitis ( NASH ) . METHODS Out patients 18 to 70 years old were recruited from Brooke Army Medical Center . All patients completed a baseline question naire and ultrasound . If fatty liver was identified , then laboratory data and a liver biopsy were obtained . RESULTS Four hundred patients were enrolled . Three hundred and twenty-eight patients completed the question naire and ultrasound . Mean age ( range , 28 - 70 years ) was 54.6 years ( 7.35 ) ; 62.5 % Caucasian , 22 % Hispanic , and 11.3 % African American ; 50.9 % female ; mean body mass index ( BMI ) ( calculated as kg/m(2 ) ) was 29.8 ( 5.64 ) ; and diabetes and hypertension prevalence 16.5 % and 49.7 % , respectively . Prevalence of NAFLD was 46 % . NASH was confirmed in 40 patients ( 12.2 % of total cohort , 29.9 % of ultrasound positive patients ) . Hispanics had the highest prevalence of NAFLD ( 58.3 % ) , then Caucasians ( 44.4 % ) and African Americans ( 35.1 % ) . NAFLD patients were more likely to be male ( 58.9 % ) , older ( P = .004 ) , hypertensive ( P higher BMI ( P ate fast food more often ( P = .049 ) , and exercised less ( P = 0.02 ) than their non-NAFLD counterparts . Hispanics had a higher prevalence of NASH compared with Caucasians ( 19.4 % vs 9.8 % ; P = .03 ) . Alanine aminotransferase , aspartate aminotransferase , BMI , insulin , Quantitative Insulin-Sensitivity Check Index , and cytokeratin-18 correlated with NASH . Among the 54 diabetic patients , NAFLD was found in 74 % and NASH in 22.2 % . CONCLUSION Prevalence of NAFLD and NASH is higher than estimated previously . Hispanics and patients with diabetes are at greatest risk for both NAFLD and NASH",
"OBJECTIVE The present pilot trial was carried out to evaluate the effects of an acute treatment with a mixture containing 500 million of Lactobacillus bulgaricus and Streptococcus thermophilus per day in patients with non alcoholic fatty liver disease ( NAFLD ) . RESEARCH METHODS A sample of 30 patients with NAFLD ( diagnosed by liver biopsy ) was enrolled and 28 patients were analyzed in a double blind r and omized clinical trial . Patients were r and omized to one of the following treatments during 3 months : group I , treated with one tablet per day with 500 million of Lactobacillus bulgaricus and Streptococcus thermophilus and group II , treated with one placebo tablet ( 120 mg of starch ) . RESULTS In group I , alanine amino transferase ( ALT : 67.7 + /- 25.1 vs. 60.4 + /- 30.4 UI/L ; p aspartate aminotransferase activity ( AST : 41.3 + /- 15.5 vs. 35.6 + /- 10.4 UI/L ; p gammaglutamine transferase levels ( gammaGT : 118.2 + /- 63.1 vs. 107.7 + /- 60.8 UI/L ; p liver function parameters remained unchanged ( ALT : 60.7 + /- 32.1 vs. 64.8 + /- 35.5 UI/L ; p aspartate aminotransferase activity ( AST : 31.7 + /- 13.1 vs. 36.4 + /- 13.8 UI/L ; ns ) and gammaglutamine transferase levels ( gammaGT : 82.1 + /- 55.1 vs. 83.6 + /- 65.3 UI/L ; ns ) . Anthropometric parameters and cardiovascular risk factors remained unchanged after treatment in both groups . CONCLUSION A tablet of 500 million of Lactobacillus bulgaricus and Streptococcus thermophilus , with a r and omized clinical design , improved liver aminotransferases levels in patients with NAFLD",
"Background : Regarding to the growing prevalence of nonalcoholic fatty liver disease ( NAFLD ) , concentrating on various strategies to its prevention and management seems necessary . The aim of this study was to determine the effects of symbiotic on C-reactive protein ( CRP ) , liver enzymes , and ultrasound findings in patients with NAFLD . Methods : Eighty NAFLD patients were enrolled in this r and omized , double-blind , placebo-controlled clinical trial . Participants received symbiotic in form of a 500 mg capsule ( containing seven species of probiotic bacteria and fructooligosaccharides ) or a placebo capsule daily for 8 weeks . Ultrasound grading , CRP , and liver enzymes were evaluated at the baseline and the end of the study . Results : In the symbiotic group , ultrasound grade decreased significantly compared to baseline ( P symbiotic supplementation was not associated with changes in alanine aminotransferase ( ALT ) and aspartate transaminase ( AST ) levels . In the placebo group , there was no significant change in steatosis grade whereas ALT and AST levels were significantly increased ( P = 0.002 , P = 0.02 , respectively ) . CRP values remained static in either group . Conclusions : Symbiotic supplementation improved steatosis in NAFLD patients and might be useful in the management of NAFLD or protective against its progression",
"BACKGROUND Intestinal dysbiosis has been described in Cystic Fibrosis ( CF ) and probiotics have been proposed to restore microbial composition . Aim of the study was to investigate the effects of Lactobacillus rhamnosus GG ( LGG ) on clinical outcomes in children with cystic fibrosis ( CF ) . METHODS A multicentre , r and omised double-blind , clinical trial was conducted in children with CF . After 6months of baseline assessment , enrolled children ( 2 to 16years of age ) received Lactobacillus GG ( 6 × 109CFU/day ) or placebo for 12months . Primary outcomes were proportion of subjects with at least one pulmonary exacerbation and hospitalisation over 12months . Secondary endpoints were total number of exacerbations and hospitalisations , pulmonary function , and nutritional status . RESULTS Ninety-five patients were enrolled ( 51/95 female ; median age of 103±50months ) . In a multivariate GEE logistic analysis , the odds of experiencing at least one exacerbation was not significantly different between the two groups , also after adjusting for the presence of different microbial organisms and for the number of pulmonary exacerbations within 6months before r and omisation ( OR 0.83 ; 95 % CI 0.38 to 1.82 , p=0.643 ) . Similarly , LGG supplementation did not significantly affect the odds of hospitalisations ( OR 1.67 ; 95 % CI 0.75 to 3.72 , p=0.211 ) . No significant difference was found for body mass index and FEV1 . CONCLUSIONS LGG supplementation had no effect on respiratory and nutritional outcomes in this large study population of children with CF under stringent r and omised clinical trial conditions . Whether earlier interventions , larger doses , or different strains of probiotics may be effective is unknown",
"Although non-alcoholic fatty liver disease ( NAFLD ) is the leading aetiology of liver disorders in the world , there is no proven treatment for NAFLD patients with normal or low BMI . The aim of this study was to evaluate the efficacy of synbiotics supplementation in NAFLD patients with normal or low BMI . In this r and omised , double-blind , placebo-controlled , clinical trial , fifty patients with NAFLD were assigned to take either a synbiotic supplement or a placebo capsule for 28 weeks . Both groups were advised to follow a healthy lifestyle . At the end of the study , hepatic steatosis and fibrosis reduced in both groups ; however , the mean reduction was significantly greater in the synbiotic group rather than in the placebo group ( P Furthermore , serum levels of fasting blood sugar , TAG and most of the inflammatory mediators reduced in the synbiotic group significantly compared with the placebo group ( P that synbiotic supplementation improves the main features of NAFLD in patients with normal and low BMI , at least partially through reduction in inflammatory indices . Further studies are needed to address the exact mechanism of action of these effects",
"Background Nonalcoholic fatty liver disease ( NAFLD ) is the most common chronic liver disease in developed and developing countries . The use of synbiotics has been proposed as a probable management strategy for patients with NAFLD . Objective We investigated the effects of synbiotic yogurt on hepatic steatosis and liver enzymes as primary outcomes and on oxidative stress markers , adipokine concentration , and gut peptide concentration as secondary outcomes in patients with NAFLD . Methods In this 24-wk , open-label , r and omized controlled clinical trial , 102 patients [ 50 men and 52 women ; mean age : 40 y ; body mass index ( in kg/m2 ) ( mean ± SD ) : 31.2 ± 4.9 ] were r and omly assigned to 3 groups , including 2 intervention groups and 1 control group . The intervention groups consumed 300 g synbiotic yogurt containing 108 colony-forming units Bifidobacterium animalis/mL and 1.5 g inulin or conventional yogurt daily and were advised to follow a healthy lifestyle ( i.e. , diet and exercise ) . The control group was advised to follow a healthy lifestyle alone . We evaluated differences between groups in liver function measures by using repeated- measures ANOVA , ANCOVA , and logistic regression . Results At the end of the study , the grade s of NAFLD , as determined by ultrasonography , showed a significant decrease in the synbiotic group compared with the conventional and control groups ( P respectively : serum concentration of alanine aminotransferase ( -14.5 ± 15.6 compared with 4.6 ± 15.4 and 3.1 ± 14.4 IU/L ; P = 0.008 ) , aspartate aminotransferase ( -7.5 ± 6.1 compared with 3.0 ± 8.2 and 3.1 ± 5.7 IU/L ; P ) , alkaline phosphatase ( -26.2 ± 16.8 compared with 3.4 ± 30.1 and 1.5 ± 31.9 IU/L ; P = 0.024 ) , and γ-glutamyltransferase ( -6.0 ± 6.0 compared with 1.0 ± 6.4 and 7.6 ± 11.4 IU/L ; P ) . Conclusion Synbiotic yogurt consumption improved hepatic steatosis and liver enzyme concentrations in patients with NAFLD . This trial was registered at the Iranian Registry of Clinical Trials website ( www.i rct .ir ) as I RCT 2017020932417N2",
"Pediatric obesity is rising worldwide leading the worrying phenomenon of nonalcoholic fatty liver disease ( NAFLD ) to shift into one of the most frequent causes of chronic liver illness in childhood . Occurrence of NAFLD depends on several factors such as the geographical area and the diagnostic modalities used ; overall it ranges between 3 % and 10 % of pediatric population , increasing up to 70 % in patients with metabolic comorbidities ( Manco M , Bottazzo G , DeVito R et al , J Am Coll Nutr 27:667 - 676 , 2008).Recent findings have related the intestinal microbiota to a plethora of pathological conditions , including type 2 diabetes ( T2D ) , obesity , and nonalcoholic steatohepatitis ( NASH ) . One of the emerging areas of the study is the link between liver diseases and gut microbiome , which has added new information to the underst and ing of the so-called gut-liver axis . In order to address the role of gut microbiome in NAFLD onset and progression , it is necessary to \" decipher \" operational codes for microbiome investigation within the context of advanced laboratory medicine to capture microbiome features and , hence , to address the function of the intestinal microbiome within the gut microbiota-liver axis . Results of these investigations have allowed the beginning of implementing the usage of probiotics and symbiotics in the medical approach of obesity and NAFLD in adults and children . Several r and omized clinical trials ( RCTs ) have been already published on fecal microbiota transplantation ( FMT ) , T2D , NASH , and inflammatory bowel disease (IBD).This review proposes to describe the current state of knowledge on the ways fatty liver diseases can be addressed with nutritional interventions , probiotics , symbiotics , and FMT"
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BACKGROUND This meta- analysis evaluates the efficacy of nonpharmacological treatments for conduct disorder ( CD ) problems in children and adolescents , based on child , parent and teacher report . METHODS PubMed , PsycINFO and EMBASE were search ed for peer- review ed articles published between January 1970 and March 2015 . Main inclusion criteria were nonpharmacological treatment , participants younger than 18 years , clinical CD problems/diagnosis , r and omized controlled trials and inclusion of at least one CD problem-related outcome . Treatment efficacy is expressed in effect sizes ( ESs ) calculated for each rater ( parent , teacher , self and blinded observer ) . RESULTS Of 1,549 articles retrieved , 17 ( published between June 2004 and January 2014 ) describing 19 interventions met the inclusion criteria . All studies used psychological treatments ; only three studies included a blinded observer to rate CD problems . Most studies were of very poor to fair quality . ESs were significant but small for parent-reported outcomes ( 0.36 , 95 % CI = 0.27 - 0.47 ) , teacher-reported outcomes ( 0.26 , 95 % CI = 0.12 - 0.49 ) and blinded observer outcomes ( 0.26 , 95 % CI = 0.06 - 0.47 ) , and they were nonsignificant for self-reported outcomes ( -0.01 , 95 % CI = -0.25 to 0.23 ) . Comorbidity , gender , age , number of sessions , duration , intervention type , setting , medication use or dropout percentage did not influence the effect of treatment . CONCLUSIONS Psychological treatments have a small effect in reducing parent- , teacher- and observer-rated CD problems in children and adolescents with clinical CD problems/diagnosis . There is not enough evidence to support one specific psychological treatment over another . Future studies should investigate the influence of participant characteristics ( e.g. age of CD onset ) , use more homogeneous outcome measures and allow better evaluation of study quality . Many reports failed to provide detailed information to allow optimization of psychological treatment strategies
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"This study examined the effectiveness of the universal component of the Fast Track prevention model : the PATHS ( Promoting Alternative THinking Strategies ) curriculum and teacher consultation . This r and omized clinical trial involved 198 intervention and 180 comparison classrooms from neighborhoods with greater than average crime in 4 U.S. locations . In the intervention schools , Grade 1 teachers delivered a 57-lesson social competence intervention focused on self-control , emotional awareness , peer relations , and problem solving . Findings indicated significant effects on peer ratings of aggression and hyperactive-disruptive behavior and observer ratings of classroom atmosphere . Quality of implementation predicted variation in assessment s of classroom functioning . The results are discussed in terms of both the efficacy of universal , school-based prevention models and the need to examine comprehensive , multiyear programs",
"This study was a r and omized clinical trial of Project Support , an intervention design ed to reduce conduct problems among children exposed to intimate partner violence . Participants were 66 families ( mothers and children ) with at least 1 child exhibiting clinical levels of conduct problems . Families were recruited from domestic violence shelters . The Project Support intervention involves ( a ) teaching mothers child management skills and ( b ) providing instrumental and emotional support to mothers . Families were r and omly assigned to the Project Support intervention condition or to an existing services comparison condition . They were assessed on 6 occasions over 20 months , following their departure from the shelter . Children in families in the Project Support condition , compared with those in the comparison condition , exhibited greater reductions in conduct problems . Mothers in the Project Support condition , compared with those in the comparison condition , displayed greater reductions in inconsistent and harsh parenting behaviors and psychiatric symptoms . Changes in mothers ' parenting and psychiatric symptoms accounted for a sizable proportion of Project Support 's effects on child conduct problems at the end of treatment . Clinical and policy implication s are discussed",
"Objective : To determine the effectiveness of an on-site modular intervention in improving access to mental health services and outcomes for children with behavioral problems in primary care relative to enhanced usual care . The study includes boys and girls from six primary care offices in metropolitan Pittsburgh , PA . Methods : One hundred sixty-three clinical ly referred children who met a modest clinical cutoff ( 75th percentile ) on the externalizing behavior scale of the Pediatric Symptom Checklist-17 were r and omized to a protocol for on-site , nurse-administered intervention or to enhanced usual care . Protocol for on-site , nurse-administered intervention applied treatment modules from an evidence -based specialty mental health treatment for children with disruptive behavior disorders that were adapted for delivery in the primary care setting ; enhanced usual care offered diagnostic assessment , recommendations , and facilitated referral to a specialty mental health provider in the community . The main outcome measures such as st and ardized rating scales , including the Pediatric Symptom Checklist-17 , individualized target behavior ratings , treatment termination reports , and diagnostic interviews were collected . Results : Protocol for on-site , nurse-administered intervention cases were significantly more likely to receive and complete mental health services , reported fewer service barriers and more consumer satisfaction , and showed greater , albeit modest , improvements on just a few clinical outcomes that included remission for categorical behavioral disorders at 1-year follow-up . Both conditions also reported several significant improvements on several clinical outcomes over time . Conclusions : A psychosocial intervention for behavior problems that was delivered by nurses in the primary care setting is feasible , improves access to mental health services , and has some clinical efficacy . Options for enhancing clinical outcome include the use of multifaceted collaborative care interventions in the pediatric practice",
"This study examined whether Project Support , a parenting intervention shown to reduce child conduct problems , also exerts positive effects on features of psychopathy in children . Participants were 66 families ( mothers and children ) recruited from domestic violence shelters who participated in a r and omized controlled trial evaluating Project Support . Each family included at least one child between the ages of 4 and 9 who was exhibiting clinical levels of conduct problems . Families were r and omly assigned to the Project Support intervention condition or to an existing services comparison condition , and they were assessed on 6 occasions over 20 months , following their departure from the shelter . Children in families in the Project Support condition , compared with those in the comparison condition , exhibited greater reductions in features of psychopathy . Moreover , the changes in features of psychopathy remained after accounting for changes in conduct problems . Project Support ’s effects on features of psychopathy were mediated by improvements in mothers ’ harsh and inconsistent parenting . These findings on the effects of an intervention on features of psychopathy are the first from a r and omized controlled trial . They inform the debate about whether features of psychopathy in children are responsive to intervention , and hold important implication s for clinical practice",
"The impact of the Fast Track intervention on externalizing disorders across childhood was examined . Eight hundred-ninety-one early-starting children ( 69 % male ; 51 % African American ) were r and omly assigned by matched sets of schools to intervention or control conditions . The 10-year intervention addressed parent behavior-management , child social cognitive skills , reading , home visiting , mentoring , and classroom curricula . Outcomes included psychiatric diagnoses after grade s 3 , 6 , 9 , and 12 for conduct disorder , oppositional defiant disorder , attention deficit hyperactivity disorder , and any externalizing disorder . Significant interaction effects between intervention and initial risk level indicated that intervention prevented the lifetime prevalence of all diagnoses , but only among those at highest initial risk , suggesting that targeted intervention can prevent externalizing disorders to promote the raising of healthy children",
"BACKGROUND The concept of differential susceptibility has challenged the potential meaning of personal traits such as poor ability to regulate emotions . Under the traditional model of diathesis/stress , personal characteristics such as liability to angry outbursts are seen as essentially disadvantageous , emerging under duress in a way that is maladaptive . In contrast , with differential susceptibility , there is the same poorer functioning under adverse conditions but , under favorable conditions , individuals with the trait function better than those without it . To date , there have been limited studies on response under positive environments . We used the experimental power of an intervention trial to test the differential susceptibility hypothesis that children with emotional dysregulation would show greater response to an experimentally induced improvement in their parenting environment . METHODS Data were from the SPOKES trial ( IS RCT N 77566446 ) , a r and omized controlled trial of 112 school children who were 5 - 6-years old , screened for elevated levels of oppositionality , r and omized to parenting groups or control ; 109 ( 97 % ) were followed-up a year later . Using DSM-IV oppositional-defiant symptoms , children were divided into an Emotionally-Dysregulated type ( ED , n = 68 ) and a Headstrong type ( n = 44 ) . The parenting intervention was the Incredible Years program supplemented by positive strategies to use when reading with children . Assessment of conduct problems and parenting was by semistructured interviews . RESULTS At follow-up , parents of Emotionally-Dysregulated and Headstrong children allocated to the intervention showed significant improvements in their parenting strategies to an equal extent compared to parents in the control group . However , the Emotionally-Dysregulated children showed a significantly greater decrease in conduct problems between intervention and control groups ( treatment effect-size 0.84 st and ard deviations ) than the Headstrong ( es 0.20 SD ) , p = 0.04 . CONCLUSIONS Using the power of a controlled experiment , this study showed that children who exhibited Emotionally-Dysregulated behavior pretreatment were more responsive to improvements in parental care that were experimentally induced . The findings extend prior work on differential sensitivity in suggesting that children exhibiting irascibility and emotionality may show greater susceptibility to the caregiving environment , and may identify a subset of children who respond better to existing treatments",
"OBJECTIVE To evaluate the effectiveness and mechanisms of Hitkashrut , a \" common elements \" co-parent training ( PT ) program for early intervention with preschoolers ( 3 - 5 years of age ) at risk for conduct problems ( CP ) . METHOD A r and omized controlled trial with 140 participants in PT and 69 in a minimal intervention control group . The primary outcome ( presence of CP ) was assessed at pre-intervention , post-intervention , and 1-year follow-up . Callous-unemotional traits , effortful control , parental distress , negative/inconsistent parenting , and couple relationship quality were assessed at pre- and post-intervention , whereas callous-unemotional traits and effortful control were also assessed in the PT group at follow-up . Retention was 87.1 % at post-intervention and 60 % at follow-up . Hitkashrut incorporated evidence -based components of established PT programs into a culturally adapted protocol . The facilitators were trained and supervised psychologists working in Israel 's Educational Psychology Services . RESULTS Intervention effect ( Cohen 's d ) was large at post-intervention ( ES = .76 , p callous-unemotional traits ( ES = 0.85 , p effortful control ( ES = 0.47 , p CP was mediated by improvements in parental practice s and distress . CONCLUSIONS Hitkashrut 's implementation and subsequent dissemination in real-world setting s demonstrates the potential effectiveness of common elements programs to promote innovations within service-delivery systems . Improvements in dispositional variables and the mediated follow-up effect support theoretical cascade models that emphasize early developmental malleability and the growing preventive effects of PT 's facilitated parental changes on disruptive developmental trajectories . Clinical trial registration information - The effect of a \" common elements \" co-parent training program ( called ' Hitkashrut ' ) on conduct in preschoolers at risk for conduct problems ; http://www.anzctr.org.au ; ACTRN12612000148875",
"IMPORTANCE Disruptive behavior disorders , such as attention-deficient/hyperactivity disorder and oppositional defiant disorder , are common and stable throughout childhood . These disorders cause long-term morbidity but benefit from early intervention . While symptoms are often evident before preschool , few children receive appropriate treatment during this period . Group parent training , such as the Incredible Years program , has been shown to be effective in improving parenting strategies and reducing children 's disruptive behaviors . Because they already monitor young children 's behavior and development , primary care pediatricians are in a good position to intervene early when indicated . OBJECTIVE To investigate the feasibility and effectiveness of parent-training groups delivered to parents of toddlers in pediatric primary care setting s. DESIGN , SETTING , AND PARTICIPANTS This r and omized clinical trial was conducted at 11 diverse pediatric practice s in the Greater Boston area . A total of 273 parents of children between 2 and 4 years old who acknowledged disruptive behaviors on a 20-item checklist were included . INTERVENTION A 10-week Incredible Years parent-training group co-led by a research clinician and a pediatric staff member . MAIN OUTCOMES AND MEASURES Self-reports and structured videotaped observations of parent and child behaviors conducted prior to , immediately after , and 12 months after the intervention . RESULTS A total of 150 parents were r and omly assigned to the intervention or the waiting-list group . An additional 123 parents were assigned to receive intervention without a r and omly selected comparison group . Compared with the waiting-list group , greater improvement was observed in both intervention groups ( P parenting practice s and child disruptive behaviors that were attributable to participation in the Incredible Years groups . This study demonstrated the feasibility and effectiveness of parent-training groups conducted in pediatric office setting s to reduce disruptive behavior in toddlers . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00402857",
"OBJECTIVE Multifamily psychoeducational psychotherapy ( MF-PEP ) is an efficacious treatment for children with mood disorders . Given the comorbidity between disruptive behaviors and mood disorders , this study examined associations between disruptive behaviors and impairment , impact of MF-PEP on disruptive behaviors , and whether disruptive behaviors affected treatment response of mood symptoms . METHOD Secondary analyses examined a r and omized controlled trial of MF-PEP versus waitlist control ( N = 165 children 8 - 11 years old with mood disorders and their parents ) . Comorbid behavioral diagnoses occurred in 97 % of children . All participants continued treatment as usual . RESULTS Greater degree of disruptive behaviors was associated with worse mood symptoms and impairment . Between-group analyses examining outcome of disruptive behaviors were nonsignificant . Within-group analyses and between-group effect sizes suggested that MF-PEP was associated with decreases in attention-deficit/hyperactivity disorder ( d = 0.39 ) , oppositional defiant disorder ( d = 0.30 ) , and overall disruptive behavior symptoms ( d = 0.30 ) , but not conduct disorder symptoms . Baseline severity of disruptive behaviors did not affect treatment response of mood symptoms to MF-PEP . CONCLUSIONS MF-PEP is an effective intervention for children with mood disorders and provides some benefit for disruptive behaviors . Given that disruptive behavior severity does not affect children 's ability to experience improved mood symptoms , MF-PEP may be an important early intervention for children with comorbid mood and disruptive behavior disorders . Subsequent intervention targeting behavioral symptoms after improvement in mood may be beneficial . Studies examining treatment sequencing for children with comorbid mood and disruptive behavior disorders are needed . Clinical trial registration information-Family psychoeducation for children with mood disorders ; http:// clinical trials.gov ; NCT00050557",
"In this study , generalisation effects to day-care/school setting s were examined in an outpatient clinic sample of 127 children aged 4–8 years treated because of oppositional conduct problems in the home with parent training ( PT ) and parent training combined with child therapy ( CT ) ( “ Incredible Years ” ) . Before treatment all children scored above the 90th percentile on the Eyberg Child Behavior Inventory ( ECBI ) for home problems , and met criteria for a possible or a confirmed diagnosis of either an oppositional defiant ( ODD ) or a conduct ( CD ) disorder . Further , 83 % of the children showed clinical levels of conduct problems both at home and in day-care/school before treatment . Although most children improved at home , the majority still showed clinical levels of conduct problems in day-care/school setting s after treatment and 1-year later . Combined PT and CT produced the most powerful and significant generalisation effects across the treatment period , however these improvements were not maintained 1-year later for most areas . The results of the present study , therefore , underline the need to target conduct problems not only exhibited at home but also in day-care/school setting s , and to develop strategies to maintain positive generalisation effects after treatment for this age and problem-group",
"This study examines the impact of a brief booster treatment administered 3 years after the delivery of an acute treatment in a group ( n = 118 ) of clinical ly referred boys and girls ( ages 6 to 11 ) originally diagnosed with Oppositional Defiant Disorder ( ODD ) or Conduct Disorder ( CD ) . At the conclusion of the acute treatment and three-year follow-up period ( i.e. , study month 42 ) , the sample was re-r and omized into Booster treatment or Enhanced Usual Care and then assessed at four later timepoints ( i.e. , post-booster , and 6- , 12- and 24-month booster follow-up ) . Booster treatment was directed towards addressing individualized problems and some unique developmental issues of adolescence based on the same original protocol content and treatment setting , whereas the Enhanced Usual Care condition involved providing clinical recommendations based on the assessment and an outside referral for services . HLM analyses identified no significant group differences and few time effects across child , parent , and teacher reports on a broad range of child functioning and impairment outcomes . Analyses examining the role of putative moderators or predictors ( e.g. , severity of externalizing behavior , dose of treatment ) were likewise non-significant . We discuss the nature and implication s of these novel findings regarding the role and timing of booster treatment to address the continuity of DBD over time",
"Early onset disruptive behavior disorders are overrepresented in low-income families ; yet these families are less likely to engage in behavioral parent training ( BPT ) than other groups . This project aim ed to develop and pilot test a technology-enhanced version of one evidence -based BPT program , Helping the Noncompliant Child ( HNC ) . The aim was to increase engagement of low-income families and , in turn , child behavior outcomes , with potential cost-savings associated with greater treatment efficiency . Low-income families of 3- to 8-year-old children with clinical ly significant disruptive behaviors were r and omized to and completed st and ard HNC ( n = 8) or Technology-Enhanced HNC ( TE-HNC ; n = 7 ) . On average , caregivers were 37 years old ; 87 % were female , and 80 % worked at least part-time . More than half ( 53 % ) of the youth were boys ; the average age of the sample was 5.67 years . All families received the st and ard HNC program ; however , TE-HNC also included the following smartphone enhancements : ( a ) skills video series , ( b ) brief daily surveys , ( c ) text message reminders , ( d ) video recording home practice , and ( e ) midweek video calls . TE-HNC yielded larger effect sizes than HNC for all engagement outcomes . Both groups yielded clinical ly significant improvements in disruptive behavior ; however , findings suggest that the greater program engagement associated with TE-HNC boosted child treatment outcome . Further evidence for the boost afforded by the technology is revealed in family responses to post assessment interviews . Finally , cost analysis suggests that TE-HNC families also required fewer sessions than HNC families to complete the program , an efficiency that did not compromise family satisfaction . TE-HNC shows promise as an innovative approach to engaging low-income families in BPT with potential cost-savings and , therefore , merits further investigation on a larger scale",
"This r and omized clinical trial assessed the effectiveness of multisystemic therapy ( MST ) for 156 youths who met the diagnostic criteria for conduct disorder . Sweden 's 3 largest cities and 1 small town served as the recruiting area for the study . A mixed factorial design was used , with r and om allocation between MST and treatment as usual groups . Assessment s were conducted at intake and 7 months after referral . With an intention-to-treat approach , results from multiagent and multi method assessment batteries showed a general decrease in psychiatric problems and antisocial behaviors among participants across treatments . There were no significant differences in treatment effects between the 2 groups . The lack of treatment effect did not appear to be caused by site differences or variations in program maturity . MST treatment fidelity was lower than that of other studies , although not clearly related to treatment outcomes in this study . The results are discussed in terms of differences between Sweden and the United States . One difference is the way in which young offenders are processed ( a child welfare approach vs. a juvenile justice system approach ) . Sociodemographic differences ( e.g. , rates of poverty , crime , and substance abuse ) between the 2 countries may also have moderating effects on the rates of rehabilitation among young offenders . ( PsycINFO Data base Record ( c ) 2008 APA , all rights reserved )",
"BACKGROUND Behavioural parent training is effective in improving child disruptive behavioural problems in preschool children by increasing parenting competence . The indicated Prevention Programme for Externalizing Problem behaviour ( PEP ) is a group training programme for parents and kindergarten teachers of children aged 3 - 6 years with externalizing behavioural problems . AIMS To evaluate the effects of PEP on child problem behaviour , parenting practice s , parent-child interactions , and parental quality of life . METHOD Parents and kindergarten teachers of 155 children were r and omly assigned to an intervention group ( n = 91 ) and a nontreated control group ( n = 64 ) . They rated children 's problem behaviour before and after PEP training ; parents also reported on their parenting practice s and quality of life . St and ardized play situations were video-taped and rated for parent-child interactions , e.g. parental warmth . RESULTS In the intention to treat analysis , mothers of the intervention group described less disruptive child behaviour and better parenting strategies , and showed more parental warmth during a st and ardized parent-child interaction . Dosage analyses confirmed these results for parents who attended at least five training sessions . Children were also rated to show less behaviour problems by their kindergarten teachers . CONCLUSIONS Training effects were especially positive for parents who attended at least half of the training sessions . ABBREVIATIONS CBCL : Child Behaviour Checklist ; CII : Coder Impressions Inventory ; DASS : Depression anxiety Stress Scale ; HSQ : Home-situation Question naire ; LSS : Life Satisfaction Scale ; OBDT : observed behaviour during the test ; PCL : Problem Checklist ; PEP : prevention programme for externalizing problem behaviour ; PPC : Parent Problem Checklist ; PPS : Parent Practice s Scale ; PS : Parenting Scale ; PSBC : Problem Setting and Behaviour checklist ; QJPS : Question naire on Judging Parental Strains ; SEFS : Self-Efficacy Scale ; SSC : Social Support Scale ; TRF : Caregiver-Teacher Report Form",
"This study examined the effects of a two-year maintenance treatment assessed at 1 and 2 years following Parent – child Interaction Therapy ( PCIT ) . Sixty-one of 100 clinic-referred children ( M age = 4 years , 4 months ) originally diagnosed with oppositional defiant disorder ( ODD ) completed the st and ard treatment and were then r and omized to PCIT maintenance treatment ( MT ) or to an assessment -only follow-up condition ( AO ) . Rating scale and observational measures from fathers , mothers , and children were collected before and after st and ard treatment and at one- and two-year follow-up assessment s. Maintenance treatment involved monthly telephone contacts from the original therapist focused on relapse prevention based on principles of PCIT . At the two-year follow-up , MT families showed few changes from post-treatment , as expected . However , the expected decrements for AO control families were not seen . Few differences between MT and AO were found at either follow-up assessment , and there were no significant differences in the rates of change during follow-up . The maintenance of gains among AO families may have result ed from the continuous enhancement of st and ard treatment or from inadvertent reinforcement for maintenance provided by the assessment s of change alone",
"OBJECTIVE To evaluate the effectiveness of a social cognitive intervention program for Dutch aggressive boys and to compare it with a social skills training and a waitlist control group . METHOD A r and omized , controlled treatment outcome study with 97 aggressive boys ( aged 9 - 13 years ) was presented . An 11-session group treatment , a social cognitive intervention program ( n = 42 ) based on Dodge 's social information-processing theory , was compared with social skills training ( n = 40 ) and waitlist control group ( n = 15 ) . Measures of aggressive behavior , self-control , social cognitive skills , and appropriate social behavior were completed before and after the group treatment and at 1-year follow-up . RESULTS The outcome of both treatment conditions indicated ( 1 ) a significant increase in appropriate social behavior , social cognitive skills , and self-control and ( 2 ) a significant decrease in aggressive behavior . There was a significant difference between treatment and no treatment and between the social cognitive intervention program and social skills training on various child , parent , and teacher measures . CONCLUSIONS The expectation that focusing on the deficits and distortions in social cognitive processes ( social cognitive intervention program ) instead of merely focusing on social skills ( social skills training ) would enhance the effectiveness was supported on child , parent , and teacher measures . At 1-year follow-up , the mean effect sizes of the social cognitive intervention program and social skills training were 0.76 and 0.56 , respectively",
"Objective : To examine the initial efficacy of parent-child interaction therapy ( PCIT ) for treating behavior problems in young children who were born premature . Method : In this r and omized , controlled trial , 28 children between the ages of 18 and 60 months , who were born , were r and omly assigned to an immediate treatment ( IT ) or waitlist ( WL ) control group . Results : After 4 months , children who received PCIT were reported by their mother to have less attention problems , aggressive behaviors , and externalizing and internalizing behavior problems , and they were observed to be more compliant to maternal comm and s than children in the WL group . In addition , mothers in the IT group interacted more positively with their child , reported lower parenting stress related to difficult child behavior and demonstrated improved parenting practice s compared with WL mothers . Behavior change maintained for 80 % of the IT children 4 months after treatment completion . Conclusions : This study demonstrates preliminary efficacy of PCIT for the treatment of behavior problems in young children who were born premature",
"BACKGROUND In a recent r and omized controlled trial ( Hendriks et al. , 2011 ) , multidimensional family therapy ( MDFT ) and cognitive behavioral therapy ( CBT ) were equally effective in reducing cannabis use in adolescents ( 13 - 18 years old ) with a cannabis use disorder ( n=109 ) . In a secondary analysis of the trial data , we investigated which pretreatment patient characteristics differentially predicted treatment effect in MDFT and CBT , in order to generate hypotheses for future patient-treatment matching . METHODS The predictive value of twenty patient characteristics , in the area of demographic background , substance use , substance-related problems , delinquency , treatment history , psychopathology , family functioning and school or work related problems , was investigated in bivariate and subsequent multivariate linear regression analyses , with baseline to month 12 reductions in cannabis use days and smoked joints as dependent variables . RESULTS Older adolescents ( 17 - 18 years old ) benefited considerably more from CBT , and younger adolescents considerably more from MDFT ( p adolescents with a past year conduct or oppositional defiant disorder , and those with internalizing problems achieved considerably better results in MDFT , while those without these coexisting psychiatric problems benefited much more from CBT ( p of MDFT and CBT in adolescents with a cannabis use disorder . If replicated , this finding suggests directions for future patient-treatment matching in adolescent substance abuse treatment"
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BACKGROUND Balneotherapy ( spa therapy ) for patients with arthritis is one of the oldest forms of therapy . One of the aims of balneotherapy is to soothe the pain , improve joint motion and as a consequence to relieve people ' suffering and make them feel well . OBJECTIVES To perform a systematic review on the effectiveness of balneotherapy for rheumatoid arthritis . SEARCH STRATEGY Using the Cochrane search strategy , studies were found by screening : 1 ) The MEDLINE CD-ROM data base from 1966 to June 2002 and 2 ) the data base from the Cochrane ' Rehabilitation and Related Therapies ' Field , the Pedro data base up to June 2002 . Also , 3 ) reference checking and 4 ) personal communications with authors was carried out to retrieve eligible studies . Date of the most recent literature search : June , 2002 SELECTION CRITERIA Studies were eligible if they were r and omised controlled trials ( RCTs ) comparing balneotherapy with any other intervention or with no intervention . Included participants all suffered from definite or classical rheumatoid arthritis ( RA ) as defined by the American Rheumatism Association Criteria ( ARA ) or by the criteria of Steinbrocker . At least one of the WHO/ILAR core set of endpoints for RA clinical trials had to be among the main outcome measures . DATA COLLECTION AND ANALYSIS The Delphi list was the criteria list used to assess the components of method ological quality . Two review ers carried out quality assessment and data extraction of the studies . Disagreements were solved by consensus . MAIN RESULTS Six trials , representing 355 people , were included in this review . Most trials reported positive findings ( the absolute improvement in measured outcomes ranged from 0 to 44 % ) , but were method ologically flawed to some extent . A ' quality of life ' outcome was reported by two trials . None of the trials performed an intention-to-treat analysis and only two performed a comparison of effects between groups . Pooling of the data was not performed ; because of heterogeneity of the studies , multiple outcome measurements , and the overall data presentation was too scarce . REVIEW ER 'S CONCLUSIONS One can not ignore the positive findings reported in most trials . However the scientific evidence is insufficient because of the poor method ological quality , the absence of an adequate statistical analysis , and the absence , for the patient , of most essential outcome measures ( pain , self assessed function , quality of life ) . Therefore , the noted " positive findings " should be viewed with caution . Because of the method ological flaws an answer about the apparent effectiveness of balneotherapy can not be provided at this moment . A large , method ological sound trial is needed
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"OBJECTIVE To conduct a preliminary investigation of the effects on floatation spa therapy on quality of life in patients with osteoarthritis to see if controlled trials are warranted . DESIGN Uncontrolled clinical trial . SETTING Private floatation spa therapy centre . PATIENTS Fourteen patients with chronic osteoarthritis of the weight-bearing joints , of whom four dropped out . INTERVENTION Six weekly sessions of floatation spa therapy . OUTCOME MEASURES SF36 , AIMS 2 and MYMOP quality -of-life question naires . MAIN RESULTS All patients improved . Differences between baseline and discharge scores showed statistically significant improvement for MYMOP , but not AIMS 2 or SF-36 . CONCLUSIONS Controlled trials of floatation spa therapy for patients with osteoarthritis are warranted",
"Forty patients with classical or definite rheumatoid arthritis in a stage of active disease were treated for two weeks at a spa hotel . The patients were divided into four groups of 10 . Group I was treated with daily mud packs , group II with daily hot sulphur baths , group III with a combination of mud packs and hot sulphur baths , and group IV served as a control group . The patients were assessed by a rheumatologist who was blinded to the treatment modalities . Statistically significant improvement for a period of up to three months was observed in the three treatment groups in most of the clinical indices . Improvement in the control group was minor in comparison and not statistically significant . No significant improvement was observed in any of the laboratory variables measured . Except for three mild cases of thermal reaction there were no side effects",
"Abstract The purpose of this study was to evaluate the immediate and delayed effects of balneotherapy at the Dead Sea on patients with psoriatic arthritis ( PsA ) . A total of 42 patients with PsA were treated at the Dead Sea for 4 weeks . Patients were r and omly allocated into two groups : group 1 ( 23 patients ) and group 2 ( 19 patients ) . Both groups received daily exposure to sun ultraviolet rays and regular bathing at the Dead Sea . Group 1 was also treated with mud packs and sulfur baths . Patients were assessed by a dermatologist and a rheumatologist 3 days before arrival , at the end of treatment , and at weeks 8 , 16 , and 28 from the start of treatment . The clinical indices assessed were morning stiffness , right and left h and grip , number of tender joints , number of swollen joints , Schober test , distance from finger to floor when bending forward , patient 's self- assessment of disease severity , inflammatory neck and back pain and psoriasis area and severity index ( PASI ) score . Comparison between groups disclosed a similar statistically significant improvement for variables such as PASI , morning stiffness , patient self- assessment , right and left grip , Schober test and distance from finger to floor when bending forward . For variables such as tender and swollen joints , and inflammatory neck and back pain , improvement over time was statistically significant in group 1 . Addition of mud packs and sulfur baths to sun ultraviolet exposure and Dead Sea baths seems to prolong beneficial effects and improves inflammatory back pain",
"OBJECTIVE To determine the efficacy of combined spa-exercise therapy in addition to st and ard treatment with drugs and weekly group physical therapy in patients with ankylosing spondylitis ( AS ) . METHODS A total of 120 Dutch out patients with AS were r and omly allocated into 3 groups of 40 patients each . Group 1 ( mean age 48 + /- 10 years ; male : female ratio 25:15 ) was treated in a spa resort in Bad Hofgastein , Austria ; group 2 ( mean age 49 + /- 9 years ; male : female ratio 28:12 ) in a spa resort in Arcen , The Netherl and s. The control group ( mean age 48 + /- 10 years ; male : female ratio 34:6 ) stayed at home and continued their usual drug treatment and weekly group physical therapy during the intervention weeks . St and ardized spa-exercise therapy of 3 weeks duration consisted of group physical exercises , walking , correction therapy ( lying supine on a bed ) , hydrotherapy , sports , and visits to either the Gasteiner Heilstollen ( Austria ) or sauna ( Netherl and s ) . After spa-exercise therapy all patients followed weekly group physical therapy for another 37 weeks . Primary outcomes were functional ability , patient 's global well-being , pain , and duration of morning stiffness , aggregated in a pooled index of change ( PIC ) . RESULTS Analysis of variance showed a statistically significant time-effect ( P spa-exercise therapy , the mean difference in PIC between group 1 and controls was 0.49 ( 95 % confidence interval [ CI ] 0.16 - 0.82 , P = 0.004 ) and between group 2 and controls was 0.46 ( 95 % CI 0.15 - 0.78 , P = 0.005 ) . At 16 weeks , the difference between group 1 and controls was 0.63 ( 95 % CI 0.23 - 1.02 , P = 0.002 ) and between group 2 and controls was 0.34 ( 95 % CI--0.05 - 0.73 ; P = 0.086 ) . At 28 and 40 weeks , more improvement was found for group 1 compared with controls ( P = 0.012 and P = 0.062 , respectively ) but not for group 2 compared with controls . CONCLUSION In patients with AS , a 3-week course of combined spa-exercise therapy , in addition to drug treatment and weekly group physical therapy alone , provides beneficial effects . These beneficial effects may last for at least 40 weeks",
"The objective of this study was to evaluate the effect of spa therapy on clinical parameters of patients with gonarthrosis . Patients with gonarthrosis ( n=33 ) underwent a 2-week spa therapy using three treatment regimes and a 20-week follow-up as follows : group I ( n=11 ) had mineral water baths and hot native mineral mud packs , group II ( n=12 ) had mineral water baths and rinsed mineral-free mud packs and group III ( n=10 ) had tap water baths and mineral-free mud packs . The patients and the assessing rheumatologist were blinded to the difference in the treatment protocol s. A significant improvement in the index of severity of the knee ( ISK ) , as well as night pain scores , was achieved in group I. Improvement in physical findings and a reduction in pain ratings on a visual analogue scale ( VAS ) did not reach statistical significance . Analgesic consumption was significantly decreased in both groups I and III for up to 12 weeks . Global improvement assessed by patients and physician was observed in all three groups up to 16 weeks but persisted to the end of the follow-up period in group I only . Patients with gonarthrosis seemed to benefit from spa therapy under all three regimes . However , for two parameters ( night pain and ISK ) the combination of mineral water baths and mud packs ( group I ) appeared to be superior",
"The effect of \" Kangal Hot Spring with Fish \" in the treatment of psoriasis is investigated . The study was carried out on 87 patients with psoriasis vulgaris and the patients were evaluated by a dermatologist for 21 days . The evaluation of the disease was performed using PASI ( Psoriasis Area and Severity Index ) scores . Recurrences were investigated in the patient population , who had been previously treated in the same hot spring . The first examination scores were significantly higher than the scores of the 3 , 6 , 9 , 12 , 15 and 21 days after treatment ( p Longer remission periods , when compared to the topical corticosteroid treatment , expressed by the 35 patients previously treated in hot spring ( p < 0.01 ) . Spa therapy under observation of a dermatologist may be effective and useful for psoriasis vulgaris patients",
"Abstract . The aim of this study was to evaluate the effectiveness of balneotherapy on patients with fibromyalgia ( FM ) at the Dead Sea . Forty-eight patients with FM were r and omly assigned to a treatment group receiving sulfur baths and a control group . All participants stayed for 10 days at a Dead Sea spa . Physical functioning , FM-related symptoms , and tenderness measurements ( point count and dolorimetry ) were assessed at four time points : prior to arrival at the Dead Sea , after 10 days of treatment , and 1 and 3 months after leaving the spa . Physical functioning and tenderness moderately improved in both groups . With the exception of tenderness threshold , the improvement was especially notable in the treatment group and it persisted even after 3 months . Relief in the severity of FM-related symptoms ( pain , fatigue , stiffness , and anxiety ) and reduced frequency of symptoms ( headache , sleep problems , and subjective joint swelling ) were reported in both groups but lasted longer in the treatment group . In conclusion , treatment of FM at the Dead Sea is effective and safe and may become an additional therapeutic modality in FM . Future studies should address the outcome and possible mechanisms of this treatment in FM patients",
"Objective : The present exploratory study sought to examine the changes of well-being associated with 3 weeks of resort based spa therapy . This is a traditional form of health enhancement incorporating balneotherapy , physical therapies , and health education in an inpatient setting . Patients and Method : Subjects were spa patients ( n = 153 , mean age 58 years ) with chronic pain and other age related complaints of moderately higher than normal prevalence . The well-being variables were vegetative complaints , pain , fatigue , positive and negative mood , and health satisfaction assessed at the beginning and end of spa treatment as well as 5 weeks and 12 months thereafter . Results : Well-being improved significantly in all variables during spa therapy , the improvement continuing with a slight deterioration at 5 weeks after the stay . After 12 months , vegetative complaints and fatigue had again reached pre-spa levels , whereas pain , positive and negative mood as well as health satisfaction remained improved . Both patients with high and low levels of pain increase their well-being , although pain patients showed greater improvements in some of the measures . Subjects not responding to spa therapy were older and showed less health satisfaction . Conclusions : The results suggest that spa therapy may be a powerful tool in enhancing well-being in progressed middle aged adults with common health impairments",
"Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists",
"Abstract : Fibromyalgia ( FS ) is an idiopathic chronic pain syndrome defined by widespread non-articular musculoskeletal pain and generalised tender points . As there is no effective treatment , patients with this condition have impaired quality of life ( QoL ) . The aim of this study was to assess the possible effect of balneotherapy at the Dead Sea area on the QoL of patients with FS . Forty-eight subjects participated in the study ; half of them received balneotherapy , and half did not . Their QoL ( using SF-36 ) , psychological well-being and FS-related symptoms were assessed prior to arrival at the spa hotel in the Dead Sea area , at the end of the 10-day stay , and 1 and 3 months later . A significant improvement was reported on most subscales of the SF-36 and on most symptoms . The improvement in physical aspects of QoL lasted usually 3 months , but on psychological measures the improvement was shorter . Subjects in the balneotherapy group reported higher and longer-lasting improvement than subjects in the control group . In conclusion , staying at the Dead Sea spa , in addition to balneotherapy , can transiently improve the QoL of patients with FS . Other studies with longer follow-up are needed to support our findings",
"OBJECTIVE To quantify the efficacy of a series of baths containing natural radon and carbon dioxide ( 1.3 kBq/l , 1.6 g carbon dioxide/l on average ) versus artificial carbon dioxide baths alone in patients with rheumatoid arthritis . SUBJECTS Sixty patients participating in an in-patient rehabilitation programme including a series of 15 baths were r and omly assigned to two groups . DESIGN Pain intensity ( 100 mm visual analogue scale ) and functional restrictions [ Keitel functional test , Arthritis Impact Measurement Scales ( AIMS question naire ) ] were measured at baseline , after completion of treatment and 3 and 6 months thereafter . To investigate whether the overall value of the outcomes was the same in both groups , the overall mean was analysed by Student 's t-test for independent sample s. RESULTS The two groups showed a similar baseline situation . After completion of treatment , relevant clinical improvements were observed in both groups , with no notable group differences . However , the follow-up revealed sustained effects in the radon arm , and a return to baseline levels in the sham arm . After 6 months , marked between-group differences were found for both end-points ( pain intensity : -16.9 % , 95 % confidence interval -27.6 to -6.2 % ; AIMS score : 0.57 , 95 % confidence interval 0.16 to 0.98 ) . The between-group differences were statistically significant for both overall means ( pain intensity , P : = 0.04 ; AIMS , P : = 0.01 ) . CONCLUSION Marked short-term improvements in both groups at the end of treatment may have masked potential specific therapeutic effects of radon baths . However , after 6 months of follow-up the effects were lasting only in patients of the radon arm . This suggests that this component of the rehabilitative intervention can induce beneficial long-term effects",
"OBJECTIVE The aim of this study was to evaluate the therapeutic effects of hydrotherapy which combines elements of warm water immersion and exercise . It was predicted that hydrotherapy would result in a greater therapeutic benefit than either of these components separately . METHODS One hundred thirty-nine patients with chronic rheumatoid arthritis were r and omly assigned to hydrotherapy , seated immersion , l and exercise , or progressive relaxation . Patients attended 30-minute sessions twice weekly for 4 weeks . Physical and psychological measures were completed before and after intervention , and at a 3-month followup . RESULTS All patients improved physically and emotionally , as assessed by the Arthritis Impact Measurement Scales 2 question naire . Belief that pain was controlled by chance happenings decreased , signifying improvement . In addition , hydrotherapy patients showed significantly greater improvement in joint tenderness and in knee range of movement ( women only ) . At followup , hydrotherapy patients maintained the improvement in emotional and psychological state . CONCLUSIONS Although all patients experienced some benefit , hydrotherapy produced the greatest improvements . This study , therefore , provides some justification for the continued use of hydrotherapy",
"Spa therapy is frequently used in daily rheumatological practice , but its benefit remains to be evaluated . A prospect i ve r and omized controlled study was conducted in 1993 in patients with osteoarthritis of the hip , knee or lumbar spine . Treatment was either spa therapy at Vichy ( France ) of 3 weeks duration ( spa group ) or usual therapy ( control group ) . Assessment criteria were pain ( visual analogue scale ) , functional impairment ( Lequesne 's index for hip or knee disease , Main and Waddell 's for lumbar spinal diseases ) , quality of life index [ revised Arthritis Impact Measurement Scale ( AIMS 2 ) ] , and analgesic and /or non-steroidal anti-inflammatory drug ( NSAID ) consumption . Patients were included by r and omization into one of the two arms ( spa or control ) and assessment criteria were collected before spa therapy or the control period , and 3 and 24 weeks thereafter . A total of 188 patients ( lumbar spine 95 , knee 64 , hip 29 ) were included in the study ( spa group 91 , control group 97 ) . Changes in the assessment criteria after a 6 month follow-up period showed improvement in terms of pain , functional impairment and quality of life , with a reduced intake of symptomatic drugs ( NSAID and analgesic drugs ) in the spa group . This study suggests that spa therapy of 3 weeks duration has a prolonged , beneficial , symptomatic effect in osteoarthritis",
"A quantitative systematic review , or meta- analysis , uses statistical methods to combine the results of multiple studies . Meta-analyses have been done for systematic review s of therapeutic trials , diagnostic test evaluations , and epidemiologic studies . Although the statistical methods involved may at first appear to be mathematically complex , their purpose is simple : They are trying to answer four basic questions . Are the results of the different studies similar ? To the extent that they are similar , what is the best overall estimate ? How precise and robust is this estimate ? Finally , can dissimilarities be explained ? This article provides some guidance in underst and ing the key technical aspects of the quantitative approach to these questions . We have avoided using equations and statistical notations ; interested readers will find implementations of the described methods in the listed references . We focus here on the quantitative synthesis of reports of r and omized , controlled , therapeutic trials because far more meta-analyses on therapeutic studies than on other types of studies have been published . For practical reasons , we present a stepwise description of the tasks that are performed when statistical methods are used to combine data . These tasks are 1 ) deciding whether to combine data and defining what to combine , 2 ) evaluating the statistical heterogeneity of the data , 3 ) estimating a common effect , 4 ) exploring and explaining heterogeneity , 5 ) assessing the potential for bias , and 6 ) presenting the results . Deciding Whether To Combine Data and Defining What To Combine By the time one performs a quantitative synthesis , certain decisions should already have been made about the formulation of the question and the selection of included studies . These topics were discussed in two previous articles in this series [ 1 , 2 ] . Statistical tests can not compensate for lack of common sense , clinical acumen , and biological plausibility in the design of the protocol of a meta- analysis . Thus , a reader of a systematic review should always address these issues before evaluating the statistical methods that have been used and the results that have been generated . Combining poor- quality data , overly biased data , or data that do not make sense can easily produce unreliable results . The data to be combined in a meta- analysis are usually either binary or continuous . Binary data involve a yes/no categorization ( for example , death or survival ) . Continuous data take a range of values ( for example , change in diastolic blood pressure after antihypertensive treatment , measured in mm Hg ) . When one is comparing groups of patients , binary data can be summarized by using several measures of treatment effect that were discussed earlier in this series [ 3 ] . These measures include the risk ratio ; the odds ratio ; the risk difference ; and , when study duration is important , the incidence rate . Another useful clinical measure , the number needed to treat ( NNT ) , is derived from the inverse of the risk difference [ 3 ] . Treatment effect measures , such as the risk ratio and the odds ratio , provide an estimate of the relative efficacy of an intervention , whereas the risk difference describes the intervention 's absolute benefit . The various measures of treatment effect offer complementary information , and all should be examined [ 4 ] . Continuous data can be summarized by the raw mean difference between the treatment and control groups when the treatment effect is measured on the same scale ( for example , diastolic blood pressure in mm Hg ) , by the st and ardized mean difference when different scales are used to measure the same treatment effect ( for example , different pain scales being combined ) , or by the correlation coefficients between two continuous variables [ 5 ] . The st and ardized mean difference , also called the effect size , is obtained by dividing the difference between the mean in the treatment group and the mean in the control group by the SD in the control group . Evaluating the Statistical Heterogeneity of the Data This step is intended to answer the question , Are the results of the different studies similar ( homogeneous ) ? It is important to answer this question before combining any data . To do this , one must calculate the magnitude of the statistical diversity ( heterogeneity ) of the treatment effect that exists among the different sets of data . Statistical diversity can be thought of as attributable to one or both of two causes . First , study results can differ because of r and om sampling error . Even if the true effect is the same in each study , the results of different studies would be expected to vary r and omly around the true common fixed effect . This diversity is called the within- study variance . Second , each study may have been drawn from a different population , depending on the particular patients chosen and the interventions and conditions unique to the study . Therefore , even if each study enrolled a large patient sample , the treatment effect would be expected to differ . These differences , called r and om effects , describe the between- study variation with regard to an overall mean of the effects of all of the studies that could be undertaken . The test most commonly used to assess the statistical significance of between- study heterogeneity is based on the chi-square distribution [ 6 ] . It provides a measure of the sum of the squared differences between the results observed and the results expected in each study , under the assumption that each study estimates the same common treatment effect . A large total deviation indicates that a single common treatment effect is unlikely . Any pooled estimate calculated must account for the between- study heterogeneity . In practice , this test has low sensitivity for detecting heterogeneity , and it has been suggested that a liberal significance level , such as 0.1 , should be used [ 6 ] . Estimating a Common Effect The questions that this step tries to answers are , 1 ) To the extent that data are similar , what is their best common point estimate of a therapeutic effect , and 2 ) how precise is this estimate ? The mathematical process involved in this step generally involves combining ( pooling ) the results of different studies into an overall estimate . Compared with the results of individual studies , pooled results can increase statistical power and lead to more precise estimates of treatment effect . Each study is given a weight according to the precision of its results . The rationale is that studies with narrow CIs should be weighted more heavily than studies with greater uncertainty . The precision is generally expressed by the inverse of the variance of the estimate of each study . The variance has two components : the variance of the individual study and the variance between different studies . When the between- study variance is found to be or assumed to be zero , each study is simply weighted by the inverse of its own variance , which is a function of the study size and the number of events in the study . This approach characterizes a fixed-effects model , as exemplified by the Mantel-Haenszel method [ 7 , 8 ] or the Peto method [ 9 ] for dichotomous data . The Peto method has been particularly popular in the past . It has the advantage of simple calculation ; however , although it is appropriate in most cases , it may introduce large biases if the data are unbalanced [ 10 , 11 ] . On the other h and , r and om-effects models also add the between- study variance to the within- study variance of each individual study when the pooled mean of the r and om effects is calculated . The r and om-effects model most commonly used for dichotomous data is the DerSimonian and Laird estimate of the between- study variance [ 12 ] . Fixed- and r and om-effects models for continuous data have also been described [ 13 ] . Pooled results are generally reported as a point estimate and CI , typically a 95 % CI . Other quantitative techniques for combining data , such as the Confidence Profile Method [ 14 ] , use Bayesian methods to calculate posterior probability distributions for effects of interest . Bayesian statistics are based on the principle that each observation or set of observations should be viewed in conjunction with a prior probability describing the prior knowledge about the phenomenon of interest [ 15 ] . The new observations alter this prior probability to generate a posterior probability . Traditional meta- analysis assumes that nothing is known about the magnitude of the treatment effect before r and omized trials are performed . In Bayesian terms , the prior probability distribution is noninformative . Bayesian approaches may also allow the incorporation of indirect evidence in generating prior distributions [ 14 ] and may be particularly helpful in situations in which few data from r and omized studies exist [ 16 ] . Bayesian analyses may also be used to account for the uncertainty introduced by estimating the between- study variance in the r and om-effects model , leading to more appropriate estimates and predictions of treatment efficacy [ 17 ] . Exploring and Explaining Heterogeneity The next important issue is whether the common estimate obtained in the previous step is robust . Sensitivity analyses determine whether the common estimate is influenced by changes in the assumptions and in the protocol for combining the data . A comparison of the results of fixed- and r and om-effects models is one such sensitivity analysis [ 18 ] . Generally , the r and om-effects model produces wider CIs than does the fixed-effects model , and the level of statistical significance may therefore be different depending on the model used . The pooled point estimate per se is less likely to be affected , although exceptions are possible [ 19 ] . Other sensitivity analyses may include the examination of the residuals and the chi-square components [ 13 ] and assessment of the effect of deleting each study in turn . Statistically significant results that depend on a single study may require further exploration . Cumulative Meta- Analysis",
"OBJECTIVES Several studies suggest a beneficial overall effect of spa therapy in chronic musculoskeletal diseases . The present open controlled study investigated the effects of spa therapy at Bourbonne-Les-Bains , France , in patients with hip or knee osteoarthritis or low back pain . PATIENTS AND METHODS In 1998 , 102 men and women older than 50 years were included in the study . All had low back pain or lower limb osteoarthritis , and none had contraindications to spa therapy . Quality of life was assessed three times at intervals of 4 weeks , twice before and once immediately after 3 weeks of spa therapy , using the Duke Health Profile ( five dimensions and five dysfunctions ) . RESULTS Mean age was 66.4 years , and 67 % of the patients were women . Quality of life was markedly decreased as compared to the population at large ( 1996 , CFES ) . The two pretreatment evaluations produced similar quality -of-life scores . Spa therapy was associated with significant improvements in overall quality of life ( P=0.004 ) , self-esteem ( P=0.009 ) , and pain ( P=0.01 ) . CONCLUSION These findings support those of other studies conducted in France and in other European countries . They indicate that patients report meaningful improvements in their quality of life after spa therapy",
"Hydrotherapy for OA of the hip has rarely been evaluated in controlled studies . Forty-seven patients with OA of the hip were followed for 18 weeks . Patients were r and omly allocated either to a regimen of home exercises or to twice weekly hydrotherapy for 6 weeks in addition to home exercises . There was an improvement seen in both subjective and objective measures in both groups with treatment . There was no significant difference between the two groups . Response to treatment appeared independent of age , sex and radiological severity . We conclude that for most patients , a carefully grade d and supervised regimen of home exercises is beneficial and there is little benefit in adding hydrotherapy to this regimen",
"To treat cases of psoriasis , various modifications of the original Ingram method were tested for increased effectiveness and minimized side reactions . Our modified method consists of 0.1 - 0.5 % anthralin ointment application and selective UVB phototherapy with adjunctive warm water bath and the application of emollients . The object of this study was to evaluate the effectiveness and duration of remission in response to our modified Ingram method and compare the data with the severity of psoriasis . The clearing rate was higher and the failure rate was lower in the moderate group . The number of occasions on which therapy was used and the duration of this therapy were greater in the severe group , but there were no significant differences except for the number of occasions of therapy to the trunk . Fifty-eight percent of the moderate group did not relapse in more than one year , but 63 % of the severe group relapsed within six months . The results of this study showed that the modified Ingram regimen is an effective therapeutic modality in psoriasis , especially in the moderate group",
"BACKGROUND / PURPOSE Apart from climatotherapy and spa therapy , combined treatment with salt water baths and artificial UV radiation ( balneophototherapy ) has been advocated for the treatment of psoriasis . As there is a lack of controlled studies on balneophototherapy ( BPT ) , we conducted a r and omized , one-blind , right/left comparison with salt water versus tap water in order to investigate the significance of the salt concentration in the efficacy of BPT . METHODS Ten psoriasis patients with chronic plaques on the elbows were included in the study . One elbow was soaked in 24 % NaCl solution and the other in tap water . Subsequently , broadb and UVB irradiation was administered . BPT was performed 4 times weekly with a total of 30 treatments . RESULTS A highly significant ( P clinical baseline score was observed after 30 treatments ; however , there was no significant ( P>0.5 ) difference in clearance of the psoriatic lesions between the sites soaked in salt water and tap water . CONCLUSION Our results suggest that any additional benefit of soaking in salt water and tap water in BPT are unlikely to be due to the salinity of the liquids"
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4117faaa-06ff-11f0-808a-c43d1ab1c353
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Moxibustion , an acupuncture-like intervention , is increasingly used in the management of rheumatic conditions . The aim of this review is to summarize and critically evaluate the trials testing effectiveness of moxibustion for major rheumatic conditions . Fourteen data bases were search ed from their inception through May 2010 , without language restriction . R and omized clinical trials ( RCTs ) were included if moxibustion was used as the sole treatment or as a part of a combination therapy with conventional drugs for rheumatic conditions . Cochrane criteria were used to assess the risk of bias . A total of 14 RCTs met our inclusion criteria . All were of low method ological quality . The meta- analysis of the eight RCTs suggested favorable effects of moxibustion on the response rate compared with conventional drug therapy [ n = 631 ; relative risk ( RR ) , 1.13 ; 95 % confidence intervals ( CIs ) , 1.02 to 1.26 ; P = 0.02 ] with high heterogeneity ( I2 = 58 % ) . A subgroup analysis showed significant effects of moxibustion on the RR compared with drug therapy in patients with knee osteoarthritis , whereas it failed to do so in rheumatoid arthritis . The results of meta- analysis of the six RCTs suggested favorable effects of moxibustion plus drug therapy on the response rate compared with conventional drug therapy alone ( n = 433 ; RR , 1.25 ; 95 % CIs , 1.09 to 1.43 ; P = 0.02 ) with high heterogeneity ( I2 = 62 % ) . This systematic review fails to provide conclusive evidence for the effectiveness of moxibustion compared with drug therapy in rheumatic conditions . The total number of RCTs included in this review and their method ological quality were low . These limitations make it difficult to draw firm conclusions
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[
"In this article , we test the hypothesis that r and omized clinical trials of acupuncture for pain with certain design features ( A + B versus B ) are likely to generate false positive results . Based on electronic search es in six data bases , 13 studies were found that met our inclusion criteria . They all suggested that acupuncture is effected ( one only showing a positive trend , all others had significant results ) . We conclude that the ' A + B versus B ' design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem",
"OBJECTIVES Moxibustion , a Traditional Chinese Medicine technique related to acupuncture , was proposed to facilitate cephalic version of breech presentation . Several trials were conducted to evaluate the efficacy , but there are few reports on the safety of moxibustion . Our objective was to assess the side-effects and acceptability of this intervention . DESIGN We are conducting a r and omized controlled trial to evaluate the efficacy of moxibustion for breech version . The first 12 participants r and omized in the moxibustion group had additional fetal surveillance by electronic monitoring . SUBJECTS Pregnant women with a fetus in breech presentation are included in the trial between 34 and 36 weeks of gestation . INTERVENTIONS We performed a cardiotocogram during 10 minutes before , 20 minutes during , and 10 minutes after each session . A maximum of 9 sessions were scheduled every other day , and stopped when cephalic version was diagnosed . The recordings were assessed by 3 independent readers using the Fischer scoring system . OUTCOME MEASURES Fetal well-being was evaluated by the cardiotocogram ; effect on the mother was evaluated by blood pressure recorded before and after each session ; maternal views , contractions , and perceived changes in fetal movements were assessed using a question naire . RESULTS A total of 65 cardiotocograms were analyzed . All scores were considered as normal , being at 8 or more on a 0 - 10 scale . Acceptability for the women and compliance to the intervention were good . No significant maternal or fetal side-effect was observed . CONCLUSIONS We have not detected alterations of fetal and maternal well-being or other side-effects associated with moxibustion applied to the BL 67 for cephalic version of breech presentations . Moxibustion appears to be safe for both the mother and the fetus",
"OBJECTIVE To observe the effect of Aconite cake-separated moxibustion on primary knee osteoarthritis of liver and kidney deficiency type . METHODS Fifty-six cases of such disease ( 80 knees ) were r and omly divided into a cake-separated moxibustion group ( 41 knees ) with Neixiyan ( EX-LE 5 ) , Dubi ( ST 35 ) , Yinlingquan ( SP 9 ) etc . selected , and a western medicine group ( 39 knees ) were treated with oral administration of Sodium Diclofenate Slow-released Tablet . RESULTS The cumulative score for symptoms and signs was ( 37.41 + /- 6.61 ) points before treatment and ( 9.37 + /- 8.15 ) points after treatment in the cake-separated moxibustion group and ( 37.64 - 6.00 ) points before treatment and ( 12.05 + /- 8.83 ) points after treatment in the western medicine group , with a very significant difference before and after treatment in the two groups ( P cake-separated moxibustion group and ( 15.95 + /- 9.96 ) points in the western medicine group , the former being better than the latter ( P comprehensive therapeutic effect between the two groups ( P > 0.05 ) , the cured and markedly effective rate was 63.4 % in the cake-separated moxibustion group and 48.7 % in the western medicine group , but two months after treatment , the cured and markedly effective rate of 56.1 % in the cake-separated moxibustion group was better than 33.3 % in the western medicine group ( P Aconite cake-separated moxibustion has an ideal therapeutic effect on primary knee osteoarthritis of liver and kidney deficiency type , and the therapeutic effect at anaphase is better than that of Sodium Diclofenate Slow-released Tablet",
"OBJECTIVE To observe the effect-increasing action of cake-separated mild moxibustion on rheumatoid arthritis ( RA ) , and to probe a new method for RA . METHODS Sixty cases were r and omly divided into 2 groups . The control group ( n=30 ) were treated with oral administration of methotrexate ( MTX ) as basic treatment , and non-steroid anti-inflammatory agents ( NSAIDs ) according to conditions of the patient . The treatment group ( n=30 ) were treated with the same treatment as the control group , and Fuzi case-separated moxibustion at Guanyuan ( CV 4 ) and Zusanli ( ST 36 ) was added . They were treated for 3 months . RESULTS After treatment of 3 months , the total effective rate was 83.3 % in the treatment group , which was higher than 60.0 % in the control group ( P ratio of the patients who completely withdrew NSAIDs in the treatment group was significantly higher than that in the control group ( P rate of adverse reaction in the treatment group was significantly lower than that in the control group ( P Fuzi cake-separated mild moxibustion can increase clinical therapeutic effect on RA and reduce dosage of NSAIDs",
"Moxibustion has been thought to enhance immunity in healthy condition , but suppress abnormal immune response in disease status . We collected 12 patients with systemic lupus erythematosus ( SLE ) and 12 healthy women who received indirect moxibustion on acupuncture points ST-36 ( Zusanli ) and SP-6 ( Sanyinjiao ) 20 minutes per day for 1 week . During the course , there were no changes of their regular medications or intercurrent infections in normal subjects and SLE patients . We found that indirect moxibustion for 1 week could elevate CD3 + and CD4 + T-lymphocytes in normal subjects , whereas decrease relative proportions of CD8 + T-lymphocytes in patients with SLE . This result confirms that indirect moxibustion has different immunomodulation in normal condition and autoimmune status . However , whether immunomodulatory effects of indirect moxibustion are beneficial for normal subjects and patients with SLE require further confirmation",
"OBJECTIVE To evaluate the therapeutic effect of medicated moxibustion plus administration of salicylazosulfapyridine ( SASP ) and methotrexate ( MTX ) for treatment of active ankylosing spondylitis ( AS ) . METHOD Ninety cases of active AS were r and omly assigned to Group A , B and C ( N = 30 in each group ) , and treated respectively with SASP and MTX , acupuncture plus SASP and MTX , and composite sulfur ( tablet ) moxibustion plus SASP and MTX for 3 successive courses ( 2 months each course with an interval of 5 days ) . RESULTS Improvement in sacroiliitis index , Schober test , occipital wall test , finger-ground distance , as well as the erythrocyte sedimentation rate ( ESR ) and the content of C-reactive protein ( CRP ) in Group B and C was far superior to that of Group A ( P western medicine with acupuncture or with medicated moxibustion produces a better therapeutic effect than western medicine given alone",
"OBJECTIVE To observe the clinical therapeutic effect of herb-partitioned moxibustion combined with medication on fibromyalgia syndrome . METHODS Sixty cases were r and omly divided into a treatment group and an observation group , 30 cases in each group . The observation group was treated with oral administration of amitriptyline , and the treatment group with oral administration of amitriptyline and herb-partitioned moxibustion at Dazhui ( GV 14 ) , Zhiyang ( GV 9 ) , Mingmen ( GV 4 ) , Shenshu ( BL 23 ) , Guanyuan ( CV 4 ) , Shenque ( CV 8) , and direct moxibustion at Baihui ( GV 20 ) . After treatment of one month , their clinical therapeutic effect , and changes of the number of pain points and the scores of VAS and the HAMD depression rating scale were observed . RESULTS The total effective rate was 93.3 % in the treatment group and 56.7 % in the observation group , the former being better than the latter ( P scores of VAS and HAMD and the number of pain points after treatment in the treatment group were better than those before treatment ( P score of HAMD and the number of pain points after treatment in the observation group were superior to those before treatment ( P score of VAS before and after treatment ( P>0.05 ) . After treatment , the score of HAMD and the number of pain points in the treatment group were significantly better than those in the observation group ( P score of VAS ( P>0.05 ) . CONCLUSION The herb-partitioned moxibustion combined with medication is an effective therapy for fibromyalgia syndrome"
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4117fb36-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND & OBJECTIVE ( S ) Global prevalence of type 2 diabetes ( T2D ) is very high and is currently growing alarmingly . With respect to recent research ers ' attention to the potential role of herbal medicine in disease prevention and management , the present meta- analysis review investigates the effectiveness of Nigella sativa ( N. sativa ) , a popular herb , in T2D . METHODS Literature search was conducted covering PubMed / Medline , Scopus , and Cochrane Registry of Clinical Trials up to February 2017 to obtain the relevant published intervention studies . Study selection , quality rating and data extraction of studies were investigated by two independent review ers . Heterogeneity was assessed using I-squared ( I2 ) statistics test . Subgroup analysis was done to assess type of N. sativa supplement as source of heterogeneity . Effect sizes of eligible studies were pooled using STATA software version 12 ( STATA corp , College Station , TX , USA ) . RESULTS Seven trials were included in the meta- analysis of glycemic and serum lipid profile end points . Supplementation with N. sativa significantly improved fasting blood sugar ( FBS ) [ -17.84mg/dl , 95 % CI : -21.19 to -14.49 , p total-cholesterol ( TC ) [ WMD : -22.99mg/dl , 95 % CI : -32.16 to -13.83 , p LDL-cholesterol ( LDL-c ) [ -22.38mg/dl , 95 % CI : -33.60 to -11.15 , p for triglyceride ( TG ) [ -6.80mg/dl , 95 % CI : -33.59 to 19.99 , p=0.61 ] and HDL-cholesterol ( HDL-c ) [ 0.37mg/dl , 95 % CI : -1.59 to 2.33 , p=0.71 ] were insignificant . Subgroup analysis revealed significant reduction on TG with N. sativa seed oil [ -14.8mg/dl , 95 % CI : -23.1 to -6.5 , p while TG was increased with seed powder [ 29.4mg/dl , 95 % CI : 16.9 - 42.0 , p N. sativa on glucose homeostasis and serum lipids . Current findings suggest N. sativa supplementation a suitable choice in managing the complications of T2D , although future research es are necessary
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"Hypertension ( HT ) is a lifestyle‐related disease and dietary modifications are effective for its management and prevention . We conducted a r and omized , double‐blind , placebo‐controlled trial to evaluate the efficacy of treatment with an oral Nigella sativa ( NS ) seed extract supplement in patients with mild HT . Subjects were r and omized into three groups : a placebo and two test groups that received 100 and 200 mg of NS extract twice a day . After 8 weeks , systolic blood pressure ( SBP ) values in both case groups were found to be significantly reduced when compared with the baseline values for each group . In addition , the decrease in SBP in the two case groups was statistically significant relative to the placebo group ( P , diastolic blood pressure ( DBP ) values in the case groups were found to be significantly reduced from the baseline and a significant reduction was also observed in these groups ( P reduced both SBP and DBP in a dose‐dependent manner . Meanwhile , NS extract caused a significant decline in the level of total and low‐density‐lipoprotein (LDL)‐cholesterol relative to baseline data . No complications caused by NS were observed . The results suggest that the daily use of NS seed extract for 2 months may have a blood pressure‐lowering effect in patients with mild HT",
"OBJECTIVE To examine the safety and efficacy of dapagliflozin , a sodium-glucose cotransporter-2 inhibitor , added on to pioglitazone in type 2 diabetes inadequately controlled on pioglitazone . RESEARCH DESIGN AND METHODS Treatment-naive patients or those receiving metformin , sulfonylurea , or thiazolidinedione entered a 10-week pioglitazone dose-optimization period with only pioglitazone . They were then r and omized , along with patients previously receiving pioglitazone ≥30 mg , to 48 weeks of double-blind dapagliflozin 5 ( n = 141 ) or 10 mg ( n = 140 ) or placebo ( n = 139 ) every day plus open-label pioglitazone . The primary objective compared HbA1c change from baseline with dapagliflozin plus pioglitazone versus placebo plus pioglitazone at week 24 . Primary analysis was based on ANCOVA model using last observation carried forward ; all remaining analyses used repeated- measures analysis . RESULTS At week 24 , the mean reduction from baseline in HbA1c was −0.42 % for placebo versus −0.82 and −0.97 % for dapagliflozin 5 and 10 mg groups , respectively ( P = 0.0007 and P Patients receiving pioglitazone alone had greater weight gain ( 3 kg ) than those receiving dapagliflozin plus pioglitazone ( 0.7–1.4 kg ) at week 48 . Through 48 weeks : hypoglycemia was rare ; more events suggestive of genital infection were reported with dapagliflozin ( 8.6–9.2 % ) than placebo ( 2.9 % ) ; events suggestive of urinary tract infection showed no clear drug effect ( 5.0–8.5 % for dapagliflozin and 7.9 % for placebo ) ; dapagliflozin plus pioglitazone groups had less edema ( 2.1–4.3 % ) compared with placebo plus pioglitazone ( 6.5 % ) ; and congestive heart failure and fractures were rare . CONCLUSIONS In patients with type 2 diabetes inadequately controlled on pioglitazone , the addition of dapagliflozin further reduced HbA1c levels and mitigated the pioglitazone-related weight gain without increasing hypoglycemia risk",
"The antidiabetic effect of N. sativa seed ethanol extract ( NSE ) was assessed in Meriones shawi after development of diabetes . Meriones shawi were divided r and omly into four groups : normal control , diabetic control , diabetic treated with NSE ( 2 g eq plant/kg ) or with metformin ( 300 mg/kg ) positive control , both administered by daily intragastric gavage for 4 weeks . Glycaemia and body weight were evaluated weekly . At study 's end , an Oral Glucose Tolerance Test ( OGTT ) was performed to estimate insulin sensitivity . Upon sacrifice , plasma lipid profile , insulin , leptin , and adiponectin levels were assessed . ACC phosphorylation and Glut4 protein content were determined in liver and skeletal muscle . NSE animals showed a progressive normalization of glycaemia , albeit slower than that of metformin controls . Moreover , NSE increased insulinemia and HDL-cholesterol , compared to diabetic controls . Leptin and adiponectin were unchanged . NSE treatment decreased OGTT and tended to decrease liver and muscle triglyceride content . NSE stimulated muscle and liver ACC phosphorylation and increased muscle Glut4 . These results confirm NSE 's previously reported hypoglycaemic and hypolipidemic activity . More significantly , our data demonstrate that in vivo treatment with NSE exerts an insulin-sensitizing action by enhancing ACC phosphorylation , a major component of the insulin-independent AMPK signaling pathway , and by enhancing muscle Glut4 expression",
"BACKGROUND Diabetic patients with hypertension and dyslipidemia are at a high risk of cardiovascular complications . OBJECTIVES To determine the effect of Nigella sativa supplementation on the lipid profile , mean arterial pressure , and heart rate in persons with type 2 diabetes on oral hypoglycemic agents ( OHA ) . DESIGN Single-blind , nonr and omized . SETTING Diabetes clinic of a university hospital in Saudi Arabia . PATIENTS AND METHODS Type-2 diabetic patients were recruited by purposive sampling and assigned to treatment or control at the discretion of the investigator with the patient blinded to treatment . Before the intervention and every 3 months thereafter until the end of the treatment period , the following parameters were measured : triglycerides ( TG ) , total cholesterol ( TC ) , low density lipoprotein cholesterol ( LDL-C ) , high density lipoprotein cholesterol ( HDL-C ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , mean arterial pressure ( MAP ) , heart rate ( HR ) , and body mass index ( BMI ) . Results at the baseline and each subsequent visit were compared between the two groups . MAIN OUTCOME MEASURE(S ) Lipid and cardiovascular parameters , and BMI . RESULTS Fifty-seven patients were assigned to receive N sativa 2 g daily for one year and 57 were assigned to receive an identical regimen of placebo , along with OHA . A significant decrease in HDL-C and increase in the TC/HDL-C and LDL-C/HDL-C ratios were seen in the control group . The N sativa group had a significant decline in TC , LDL-C , TC/HDL-C and LDL-C/HDL-C ratios , compared with the respective baseline data and the control group . HDL-C was significantly elevated in the N sativa group . The control group showed a significant elevation in MAP . The N sativa group had a significant reduction in SBP , DBP , MAP and HR and a significant decrease in DBP , MAP and HR as compared with the control group . CONCLUSION N sativa supplementation improves total cholesterol , mean arterial pressure and heart rate in type 2 diabetes patients on oral hypoglycemic agents . LIMITATIONS There were 9 subjects in each group lost to follow up ; thus the sample size could not be maintained as per the sample size calculation . The study was nonr and omized and thus there was a possibility of allocation bias . ( Clinical trial registration number : CTRI/2013/06/003781 , Clinical Trial Registry of India )",
"This experiment was carried out to investigate the effect of N. sativa L. on histopathology of pancreatic beta-cells , and blood insulin and glucose concentrations in streptozotocin-induced diabetic rats . Fifty male Wistar rats ( 200 - 250 g ) were divided into two experimental groups ( diabetics with no treatment and diabetics with N. sativa L. treatment ) , each containing twenty-five rats . Diabetes was induced in both groups by a single intraperitoneal injection of streptozotocin ( STZ ) ( 50 mg/kg ) . The experimental animals in both groups became diabetic within 24 hours after the administration of STZ . The rats in N. sativa L.-treated group were given the daily intraperitoneal injection of 0.20 ml/kg of N. sativa L. volatile oil for 30 days starting the day after STZ injection . Control rats received only the same amount of normal saline solution . The rats in both groups received the last injection 24 hours before the sacrification and 5 r and omly-selected rats in each group were sacrificed before , and the 1 , 10 , 20 and 30 days after the STZ injection to collect blood and pancreatic tissue sample s. The N. sativa L. treatment caused a decrease in the elevated serum glucose , an increase in the lowered serum insulin concentrations and partial regeneration/ proliferation of pancreatic beta-cells in STZ-induced diabetic rats with the elapse of the experiment . It is concluded that the hypoglycaemic action of N. sativa L. could be partly due to amelioration in the beta-cells of pancreatic islets causing an increase in insulin secretion . More studies are needed to demonstrate the exact mechanism of action of N. sativa L. on ameliorated blood glucose concentration in STZ-induced diabetes",
"The constituents of Nigella sativa modulate the immune system . The aim of the present work was to study the effectiveness of Nigella sativa oil in RA patients . Data from 40 female RA patients diagnosed according to the 2010 ACR/EULAR were analysed and discussed . The patients took two placebo ( starch filled ) capsules daily for 1 month . This was followed by a month of Nigella sativa oil capsules 500 mg twice/day . The disease activity score ( DAS-28 ) significantly decreased after receiving the Nigella sativa capsules ( 4.55 ± 0.82 ) compared with before and after placebo ( 4.98 ± 0.79 and 4.99 ± 0.72 , respectively ) ( p = 0.017 ) . Similarly , the number of swollen joints and the duration of morning stiffness improved . A marked improvement in the disease activity was shown by both the ACR20 and EULAR response criteria in 42.5 % and 30 % of the patients , respectively , after intake of Nigella . Supplementation with Nigella sativa during DMARD therapy in RA may be considered an affordable potential adjuvant biological therapy",
"UNLABELLED Diabetes mellitus is a common chronic disease affecting millions of people world wide . St and ard treatment is failing to achieve required correction of blood glucose in many patients . Therefore , there is a need for investigating potential hypoglycemic drugs or herbs to improve glycemic control in diabetic patients . Nigella sativa seeds were used as an adjuvant therapy in patients with diabetes mellitus type 2 added to their anti-diabetic medications . A total of 94 patient were recruited and divided r and omly into three dose groups . Capsules containing Nigella sativa were administered orally in a dose of 1 , 2 and 3 gm/day for three months . The effect of Nigella sativa on the glycemic control was assessed through measurement of fasting blood glucose ( FBG ) , blood glucose level 2 hours postpr and ially ( 2 hPG ) , and glycosylated hemoglobin ( HbA1c ) . Serum C-peptide and changes in body weight were also measured . Insulin resistance and beta-cell function were calculated usin the homeostatic model assessment ( HOMA2 ) . Nigella sativa at a dose of 2 gm/day caused significant reductions in FBG , 2hPG , and HbA1 without significant change in body weight . Fasting blood glucose was reduced by an average of 45 , 62 and 56 mg/dl at 4 , 8 and 12 weeks respectively . HbAlC was reduced by 1.52 % at the end of the 12 weeks of treatment ( P Insulin resistance calculated by HOMA2 was reduced significantly ( P B-cell function was increased ( P Nigella sativa in a dose of 1 gm/day also showed trends in improvement in all the measured parameters but it was not statistically significant from the baseline . However , no further increment in the beneficial response was observed with the 3 gm/day dose . The three doses of Nigella sativa used in the study did not adversely affect either renal functions or hepatic functions of the diabetic patients throughout the study period . IN CONCLUSION the results of this study indicate that a dose of 2 gm/ day of Nigella sativa might be a beneficial adjuvant to oral hypoglycemic agents in type 2 diabetic patients ",
"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"
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4117fbb8-06ff-11f0-808a-c43d1ab1c353
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Infant formulae are increasingly supplemented with probiotics , prebiotics , or synbiotics despite uncertainties regarding their efficacy . The present article , developed by the Committee on Nutrition of the European Society for Paediatric Gastroenterology , Hepatology , and Nutrition , systematic ally review s published evidence related to the safety and health effects of the administration of formulae supplemented with probiotics and /or prebiotics compared with unsupplemented formulae . Studies in which probiotics/prebiotics were not administered during the manufacturing process , but thereafter , for example in capsules , the contents of which were supplemented to infant formula or feeds , were excluded . On the basis of this review , available scientific data suggest that the administration of currently evaluated probiotic- and /or prebiotic-supplemented formula to healthy infants does not raise safety concerns with regard to growth and adverse effects . The safety and clinical effects of 1 product should not be extrapolated to other products . At present , there is insufficient data to recommend the routine use of probiotic- and /or prebiotic-supplemented formulae . The Committee considers that the supplementation of formula with probiotics and /or prebiotics is an important field of research . There is a need in this field for well- design ed and carefully conducted r and omised controlled trials , with relevant inclusion /exclusion criteria and adequate sample sizes . These studies should use vali date d clinical outcome measures to assess the effects of probiotic and /or prebiotic supplementation of formulae . Such trials should also define the optimal doses and intake duration s , as well as provide more information about the long-term safety of probiotics and /or prebiotics . Because most of the trials were company funded , independent trials , preferentially financed jointly by national/governmental/European Union bodies and other international organisations , would be desirable
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"Objective . To investigate the effect of 2 different species of probiotics in preventing infections in infants attending child care centers . Methods . A double-blind , placebo-controlled , r and omized trial was conducted from December 1 , 2000 , to September 30 , 2002 , at 14 child care centers in the Beer-Sheva area of Israel in healthy term infants 4 to 10 months old . Infants were assigned r and omly to formula supplemented with Bifidobacterium lactis ( BB-12 ) , Lactobacillus reuteri ( American Type Culture Collection 55730 ) , or no probiotics . Duration of feeding , including follow-up , for each participant was 12 weeks . All infants were fed only the assigned formula and were not breastfed due to parental decision before recruitment to the study . Probiotic or prebiotic food products or supplements were not allowed . Main outcome measures were number of days and number of episodes with fever ( > 38 ° C ) and number of days and number of episodes with diarrhea or respiratory illness . Results . Participants ( n = 201 ) were similar regarding gestational age , birth weight , gender , and previous breastfeeding . The controls ( n = 60 ) , compared with those fed B lactis ( n = 73 ) or L reuteri ( n = 68 ) , had significantly more febrile episodes ( mean [ 95 % confidence interval ] : 0.41 [ 0.28–0.54 ] vs 0.27 [ 0.17–0.37 ] vs 0.11 [ 0.04–0.18 ] , respectively ) . The controls also had more diarrhea episodes ( 0.31 [ 0.22–0.40 ] vs 0.13 [ 0.05–0.21 ] vs 0.02 [ 0.01–0.05 ] , respectively ) and episodes of longer duration ( 0.59 [ 0.34–0.84 ] vs 0.37 [ 0.08–0.66 ] vs 0.15 [ 0.12–0.18 ] days , respectively ) . The L reuteri group , compared with BB-12 or controls , had a significant decrease of number of days with fever , clinic visits , child care absences , and antibiotic prescriptions . Rate and duration of respiratory illnesses did not differ significantly between groups . Conclusions . Child care infants fed a formula supplemented with L reuteri or B lactis had fewer and shorter episodes of diarrhea , with no effect on respiratory illnesses . These effects were more prominent with L reuteri , which was also the only supplement to improve additional morbidity parameters ",
"The addition of probiotics to infant formula has been shown to be an efficient way to increase the number of beneficial bacteria in the intestine in order to promote a gut flora resembling that of breast-fed infants . The objective of the present study was to evaluate the safety and tolerance of a combination of two probiotic strains in early infancy . A group of 126 newborns were r and omised to receive a prebiotic-containing starter formula supplemented with Lactobacillus paracasei ssp . paracasei and Bifidobacterium animalis ssp . lactis or the same formula without probiotics for the first 3 months of life . A total of eighty infants continued the study until they were aged 6 months . Growth measurements were taken monthly at healthy baby clinics . Diaries were used to monitor behaviour , infections , use of antibiotics , as well as stool characteristics . Normal growth occurred in all infants and no statistically significant differences were detected between the probiotics group and the control group for gain in weight , length and head circumference . Infants in the probiotics group produced softer and more frequent stools during the first 3 months of life . No differences were found in crying and sleeping hours , number of parent-diagnosed infections , antibiotic use , visits to the general practitioner and number of adverse events . The use of a prebiotic-containing starter formula supplemented with L. paracasei ssp . paracasei and B. animalis ssp . lactis in early infancy is safe , well tolerated and has no adverse effects on growth and infant behaviour",
"ABSTRACT A healthy intestinal microbiota is considered to be important for priming of the infants ' mucosal and systemic immunity . Breast-fed infants typically have an intestinal microbiota dominated by different Bifidobacterium species . It has been described that allergic infants have different levels of specific Bifidobacterium species than healthy infants . For the accurate quantification of Bifidobacterium adolescentis , Bifidobacterium angulatum , Bifidobacterium bifidum , Bifidobacterium breve , Bifidobacterium catenulatum , Bifidobacterium dentium , Bifidobacterium infantis , and Bifidobacterium longum in fecal sample s , duplex 5′ nuclease assays were developed . The assays , targeting rRNA gene intergenic spacer regions , were vali date d and compared with conventional PCR and fluorescent in situ hybridization methods . The 5′ nuclease assays were subsequently used to determine the relative amounts of different Bifidobacterium species in fecal sample s from infants receiving a st and ard formula or a st and ard formula supplemented with galacto- and fructo-oligosaccharides ( OSF ) . A breast-fed group was studied in parallel as a reference . The results showed a significant increase in the total amount of fecal bifidobacteria ( 54.8 % ± 9.8 % to 73.4 % ± 4.0 % ) in infants receiving the prebiotic formula ( OSF ) , with a diversity of Bifidobacterium species similar to breast-fed infants . The intestinal microbiota of infants who received a st and ard formula seems to resemble a more adult-like distribution of bifidobacteria and contains relatively more B. catenulatum and B. adolescentis ( 2.71 % ± 1.92 % and 8.11 % ± 4.12 % , respectively , versus 0.15 % ± 0.11 % and 1.38 % ± 0.98 % for the OSF group ) . In conclusion , the specific prebiotic infant formula used induces a fecal microbiota that closely resembles the microbiota of breast-fed infants also at the level of the different Bifidobacterium species",
"In this double-blind , r and omized , placebo-controlled study , we investigated the effect of an infant milk formula with 6 g/L short-chain galacto- and long-chain fructo-oligosaccharides [ ( scGOS/lcFOS ) ratio 9:1 ] on the development of the fecal secretory immunoglobulin A ( sIgA ) response and on the composition of the intestinal microbiota in 215 healthy infants during the first 26 wk of life . The infants received breast milk or were r and omized to receive an infant milk formula with or without scGOS/lcFOS . Stool sample s were collected after 8 and 26 wk of intervention . The concentration of fecal sIgA was determined by ELISA , and the composition of the intestinal microbiota was determined by quantitative fluorescent in situ hybridization . The scGOS/lcFOS group and the control group were compared in the statistical analysis . A breast fed group was included as a reference . In total , 187 infants completed the study . After 26 wk of intervention , in infants that were exclusively formula fed , the concentration of sIgA was higher ( P percentages of bifidobacteria were higher in the scGOS/lcFOS group ( 60.4 % ) than in the control group ( 52.6 % , P = 0.04 ) . The percentages of Clostridium spp . were 0.0 and 3.27 % , respectively ( P = 0.006 ) . In conclusion , an infant milk formula with 6 g/L scGOS/lcFOS results in higher concentrations of fecal sIgA , suggesting a positive effect on mucosal immunity",
"A mixture of neutral short chain galactooligosaccharides and long chain fructo-oligosaccharides ( scGOS/lcFOS ) has been shown to have prebiotic and immunomodulatory effects comparable to human milk oligosaccharides . This can be translated into clinical practice as a potential to prevent infections and allergy . The hypothesis of this study was that this specific prebiotic mixture could have a preventive effect against infections during the first 6 mo of life . In a prospect i ve , r and omized , double-blind , placebo-controlled trial , healthy term infants with a parental history of atopy were fed either prebiotic-supplemented ( 8 g/L scGOS/lcFOS ) or placebo-supplemented ( 8 g/L maltodextrin ) hypoallergenic formula during the first 6 mo of life . The primary outcome measures were infectious episodes , number of infections requiring antibiotics , and incidence of infections . During the study period , infants in the scGOS/lcFOS group had fewer episodes of all types of infections combined ( P = 0.01 ) . They also tended to have fewer upper respiratory tract infection episodes ( P = 0.07 ) and fewer infections requiring antibiotic treatment ( P = 0.10 ) . Similarly , the cumulative incidence of recurring infections was significantly lower in the scGOS/lcFOS group . The cumulative incidence of any recurring infection and recurring respiratory infections was 3.9 and 2.9 % in the scGOS/lcFOS group and 13.5 and 9.6 % in the placebo group , respectively ( P Oligosaccharide prebiotics reduced the number of infectious episodes and the incidence of recurring , particularly respiratory , infections during the first 6 mo of life . Although the exact mechanism of action is under investigation , it is very likely that the immune modulating effect of this prebiotic mixture through intestinal flora modification is the principal mechanism for the observed infection prevention early in life",
"BACKGROUND Probiotics and prebiotics are considered to be beneficial to the gastrointestinal health of infants . OBJECTIVE The objective was to evaluate infant formulas containing probiotics and synbiotics ( combinations of probiotics and prebiotics ) for safety and tolerance . DESIGN In a prospect i ve , controlled , double-blind , r and omized trial , healthy full-term infants were exclusively fed a control formula or study formulas containing Bifidobacterium longum BL999 ( BL999 ) + Lactobacillus rhamnosus LPR ( LPR ) , BL999 + LPR + 4 g/L of 90 % galactooligosaccharide/10 % short-chain fructooligosaccharide ( GOS/SCFOS ) , or BL999 + Lactobacillus paracasei ST11 ( ST11 ) + 4 g/L GOS/SCFOS from . Safety and tolerance were assessed based on weight gain during the treatment period ( primary outcome ) as well as recumbent length , head circumference , digestive tolerance , and adverse events ( secondary outcomes ) , which were evaluated at 2 , 4 , 8 , 12 , 16 , and 52 wk of age . RESULTS Two hundred eighty-four infants were enrolled . During the treatment period , difference in mean weight gain between control and study formula groups in both the intention-to-treat and per- protocol population s were within the predefined equivalence boundaries of + /-3.9 g/d , indicating equivalent weight gain . Secondary outcomes did not show significant differences between groups during the treatment period . CONCLUSION Infants fed formulas containing probiotics or synbiotics show a similar rate in weight gain compared with those fed a control formula and tolerate these formulas well",
"A mixture of neutral short-chain galactooligosaccharides ( scGOS ) and long-chain fructooligosaccharides ( lcFOS ) has been shown to reduce the incidence of atopic dermatitis ( AD ) and infectious episodes during the first 6 mo of life . This dual protection occurred through the intervention period . The present study evaluated if these protective effects were lasting beyond the intervention period . In a prospect i ve , r and omized , double-blind , placebo-controlled design , healthy term infants with a parental history of atopy were fed either a prebiotic-supplemented ( 8 g/L scGOS/lcFOS ) or placebo-supplemented ( 8 g/L maltodextrin ) hypoallergenic formula during the first 6 mo of life . Following this intervention period , blind follow-up continued until 2 y of life . Primary endpoints were cumulative incidence of allergic manifestations . Secondary endpoints were number of infectious episodes and growth . Of 152 participants , 134 infants ( 68 in placebo , 66 in intervention group ) completed the follow-up . During this period , infants in the scGOS/lcFOS group had significantly lower incidence of allergic manifestations . Cumulative incidences for AD , recurrent wheezing , and allergic urticaria were higher in the placebo group , ( 27.9 , 20.6 , and 10.3 % , respectively ) than in the intervention group ( 13.6 , 7.6 , and 1.5 % ) ( P episodes of physician-diagnosed overall and upper respiratory tract infections ( P fever episodes ( P fewer antibiotic prescriptions ( P Growth was normal and similar in both groups . Early dietary intervention with oligosaccharide prebiotics has a protective effect against both allergic manifestations and infections . The observed dual protection lasting beyond the intervention period suggests that an immune modulating effect through the intestinal flora modification may be the principal mechanism of action",
"BACKGROUND Nonpathogenic live bacteria are consumed as food by many children , particularly in the form of yogurt . The tolerance and safety of long-term consumption of specific types and strains of probiotic bacteria are not well documented . OBJECTIVE The goal was to evaluate tolerance to formulas containing 2 levels of probiotic supplementation and effects on growth , general clinical status , and intestinal health in free-living healthy infants . DESIGN This was a prospect i ve , double-blind , r and omized , placebo-controlled study of healthy infants aged 3 - 24 mo . Infants were assigned to receive a st and ard milk-based formula containing 1 x 10(7 ) colony-forming units (CFU)/g each of Bifidobacterium lactis and Streptococcus thermophilus , formula containing 1 x 10(6 ) CFU/g each of B. lactis and S. thermophilus , or unsupplemented formula . Clinical outcomes included formula intake , gastrointestinal tolerance , anthropometric measures , daycare attendance , and history of illness . RESULTS One hundred eighteen infants aged ( + /- SD ) 7.0 + /- 2.9 mo at enrollment consumed formula for 210 + /- 127 d. There were no significant differences in age , sex , formula consumption , or length of study between groups . The supplemented formulas were well accepted and were associated with a lower frequency of reported colic or irritability ( P frequency of antibiotic use ( P . There were no significant differences between groups in growth , health care attention seeking , daycare absenteeism , or other health variables . CONCLUSION Long-term consumption of formulas supplemented with B. lactis and S. thermophilus was well tolerated and safe and result ed in adequate growth , reduced reporting of colic or irritability , and a lower frequency of antibiotic use",
"Adding prebiotics or probiotics to infant formula to improve the intestinal flora of formula-fed infants is considered to be a major innovation . Several companies have brought relevant formulations onto the market . However , comparative data on the effects of pre- and probiotics on the intestinal microflora of infants are not available . The present study aim ed to compare the effects of infant formula containing a mixture of galacto- and fructo-oligosaccharides or viable Bifidobacterium animalis on the composition and metabolic activity of the intestinal microflora . Before birth , infants were r and omised and double blindly allocated to one of three formulas . The prebiotic ( GOS/FOS ) group ( n 19 ) received regular infant formula supplemented with a mixture of galacto-oligosaccharides and fructo-oligosaccharides ( 6 g/l ) . The probiotic ( Bb-12 ) group ( n 19 ) received the same formula supplemented with 6.0x10(10 ) viable cells of B. animalis per litre . The st and ard group ( n 19 ) received non-supplemented regular formula . A group of sixty-three breast-fed infants was included as a reference group . Faecal sample s were taken at postnatal day 5 and 10 , and week 4 , 8 , 12 and 16 . Compared with the groups fed Bb-12 and st and ard formula , the GOS/FOS formula group showed higher faecal acetate ratio ( 69.7 % ( sem 2.7 ) , 69.9 % ( sem 3.9 ) and 82.2 % ( sem 5.3 ) ; P lactate concentration ( 11.3 ( sem 7.9 ) , 3.1 ( sem 2.3 ) and 34.7 ( sem 10.7 ) mmol/kg faeces ) and lower pH ( 6.6 ( sem 0.2 ) , 7.1 ( sem 0.2 ) and 5.6 ( sem 0.2 ) ; P percentage of bifidobacteria between the GOS/FOS ( 59.2 % ( sem 7.7 ) ) , Bb-12 ( 52.7 % ( sem 8.0 ) ) and the st and ard ( 51.8 % ( sem 6.4 ) ) groups were not statistically significant at 16 weeks . Feeding infants GOS/FOS formula result ed in a similar effect on metabolic activity of the flora as in breast-fed infants . In the Bb-12 group , composition and metabolic activity of the flora were more similar to those of the st and ard group",
"AIMS To study the bacterial diversity in expressed human milk with a focus on detecting bacteria with an antimicrobial activity against Staphylococcus aureus , known as a causative agent of maternal breast infections and neonatal infections . METHODS AND RESULTS R and om isolates ( n = 509 ) were collected from breast milk sample s ( n = 40 ) of healthy lactating women , genotypically identified , and tested for antimicrobial activity against Staph . aureus . Commensal staphylococci ( 64 % ) and oral streptococci ( 30 % ) , with Staph . epidermidis , Strep . salivarius , and Strep . mitis as the most frequent isolates , were the predominant bacterial species in breast milk . One-fifth of Staph . epidermidis and half of Strep . salivarius isolates suppressed growth of Staph . aureus . Enterococci ( Ent . faecalis ) , isolated from 7.5 % of sample s , and lactic acid bacteria ( LAB ) ( Lactobacillus rhamnosus , Lact . crispatus , Lactococcus lactis , Leuconoctoc mesenteroides ) , isolated from 12.5 % of sample s , were also effective against Staph . aureus . One L. lactis isolate was shown to produce nisin , a bacteriocin used in food industry to prevent bacterial pathogens and spoilage . CONCLUSIONS Expressed breast milk contains commensal bacteria , which inhibit Staph . aureus . SIGNIFICANCE AND IMPACT OF THE STUDY The strains inhibitory against the pathogen Staph . aureus have potential use as bacteriotherapeutic agents in preventing neonatal and maternal breast infections caused by this bacterium",
"BACKGROUND Severe acute malnutrition affects 13 million children worldwide and causes 1 - 2 million deaths every year . Our aim was to assess the clinical and nutritional efficacy of a probiotic and prebiotic functional food for the treatment of severe acute malnutrition in a HIV-prevalent setting . METHODS We recruited 795 Malawian children ( age range 5 to 168 months [ median 22 , IQR 15 to 32 ] ) from July 12 , 2006 , to March 7 , 2007 , into a double-blind , r and omised , placebo-controlled efficacy trial . For generalisability , all admissions for severe acute malnutrition treatment were eligible for recruitment . After stabilisation with milk feeds , children were r and omly assigned to ready-to-use therapeutic food either with ( n=399 ) or without ( n=396 ) Synbiotic2000 Forte . Average prescribed Synbiotic dose was 10(10 ) colony-forming units or more of lactic acid bacteria per day for the duration of treatment ( median 33 days ) . Primary outcome was nutritional cure ( weight-for-height > 80 % of National Center for Health Statistics median on two consecutive outpatient visits ) . Secondary outcomes included death , weight gain , time to cure , and prevalence of clinical symptoms ( diarrhoea , fever , and respiratory problems ) . Analysis was on an intention-to-treat basis . This trial is registered as an International St and ard R and omised Controlled Trial , number IS RCT N19364765 . FINDINGS Nutritional cure was similar in both Synbiotic and control groups ( 53.9 % [ 215 of 399 ] and 51.3 % [ 203 of 396 ] ; p=0.40 ) . Secondary outcomes were also similar between groups . HIV seropositivity was associated with worse outcomes overall , but did not modify or confound the negative results . Subgroup analyses showed possible trends towards reduced outpatient mortality in the Synbiotic group ( p=0.06 ) . INTERPRETATION In Malawi , Synbiotic2000 Forte did not improve severe acute malnutrition outcomes . The observation of reduced outpatient mortality might be caused by bias , confounding , or chance , but is biologically plausible , has potential for public health impact , and should be explored in future studies . FUNDING Department for International Development ( DfID )",
"Background : Oligosaccharides may alter postnatal immune development by influencing the constitution of gastrointestinal bacterial flora . Aims : To investigate the effect of a prebiotic mixture of galacto- and long chain fructo-oligosaccharides on the incidence of atopic dermatitis ( AD ) during the first six months of life in formula fed infants at high risk of atopy . Methods : Prospect i ve , double-blind , r and omised , placebo controlled trial ; 259 infants at risk for atopy were enrolled . A total of 102 infants in the prebiotic group and 104 infants in the placebo group completed the study . If bottle feeding was started , the infant was r and omly assigned to one of two hydrolysed protein formula groups ( 0.8 g/100 ml prebiotics or maltodextrine as placebo ) . All infants were examined for clinical evidence of atopic dermatitis . In a subgroup of 98 infants , faecal flora was analysed . Results : Ten infants ( 9.8 % ; 95 CI 5.4–17.1 % ) in the intervention group and 24 infants ( 23.1 % ; 95 CI 16.0–32.1 % ) in the control group developed AD . The severity of the dermatitis was not affected by diet . Prebiotic supplements were associated with a significantly higher number of faecal bifidobacteria compared with controls but there was no significant difference in lactobacilli counts . Conclusion : Results show for the first time a beneficial effect of prebiotics on the development of atopic dermatitis in a high risk population of infants . Although the mechanism of this effect requires further investigation , it appears likely that oligosaccharides modulate postnatal immune development by altering bowel flora and have a potential role in primary allergy prevention during infancy",
"BACKGROUND Reversal of the progressive increase in frequency of atopic disease would be an important breakthrough for health care and wellbeing in western societies . In the hygiene hypothesis this increase is attributed to reduced microbial exposure in early life . Probiotics are cultures of potentially beneficial bacteria of the healthy gut microflora . We assessed the effect on atopic disease of Lactobacillus GG ( which is safe at an early age and effective in treatment of allergic inflammation and food allergy ) . METHODS In a double-blind , r and omised placebo-controlled trial we gave Lactobacillus GG prenatally to mothers who had at least one first-degree relative ( or partner ) with atopic eczema , allergic rhinitis , or asthma , and postnatally for 6 months to their infants . Chronic recurring atopic eczema , which is the main sign of atopic disease in the first years of life , was the primary endpoint . FINDINGS Atopic eczema was diagnosed in 46 of 132 ( 35 % ) children aged 2 years . Asthma was diagnosed in six of these children and allergic rhinitis in one . The frequency of atopic eczema in the probiotic group was half that of the placebo group ( 15/64 [ 23 % ] vs 31/68 [ 46 % ] ; relative risk 0.51 [ 95 % CI 0.32 - 0.84 ] ) . The number needed to treat was 4.5 ( 95 % CI 2.6 - 15.6 ) . INTERPRETATIONS Lactobacillus GG was effective in prevention of early atopic disease in children at high risk . Thus , gut microflora might be a hitherto unexplored source of natural immunomodulators and probiotics , for prevention of atopic disease",
"Background Human milk oligosaccharides have been shown to stimulate selectively the growth of Bifidobacteria and Lactobacilli in the intestine . In this study , the bifidogenic effect of an experimental prebiotic oligosaccharide mixture consisting of low-molecular-weight galactooligosaccharides and high-molecular-weight fructooligosaccharides was analyzed in 90 term infants . Methods Two test formulas were supplemented with either 0.4 g/dL or with 0.8 g/dL oligosaccharides . In the control formula , maltodextrin was used as placebo . At study day 1 and study day 28 , the fecal species , colony forming units ( cfu ) and pH were measured and stool characteristics , growth , and side effects were recorded . Results At study day 1 , the median number of Bifidobacteria did not differ among the groups ( 0.4 g/dL group , mean [ interquartile range ] 8.5 [ 1.9 ] cfu/g ; 0.8 g/dL group , 7.7 [ 6.1 ] cfu/g ; and the placebo group , 8.8 [ 6.1 ] cfu/g ) ( figures in square brackets are interquartile range ) . At the end of the 28-day feeding period , the number of Bifidobacteria was significantly increased for both groups receiving supplemented formulas ( the 0.4 g/dL group , 9.3 [ 4.9 ] cfu/g ; the 0.8 g/dL group , 9.7 [ 0.8 ] cfu/g ) versus the placebo group ( 7.2 [ 4.9 ] cfu/g , P The number of Lactobacilli also increased significantly in both groups fed the supplemented formulas ( versus placebo , P change in fecal pH ( P the stool frequency result ed in a significant difference between the placebo group and the group fed the 0.8 g/dL formula at day 28 ( P stool consistency ( 0.8 g/dL versus placebo , P incidence of side effects ( crying , regurgitation , vomiting ) or growth . Conclusions These data indicate that supplementation of a term infant 's formula with a mixture of galacto- and fructooligosaccharides has a dose-dependent stimulating effect on the growth of Bifidobacteria and Lactobacilli in the intestine and results in softer stool with increasing dosage of supplementation",
"Antibiotics exert deleterious effects on the intestinal microbiota , favoring the emergence of opportunistic bacteria and diarrhea . Prebiotics are nondigestible food components that stimulate the growth of bifidobacteria . Our aim was to evaluate the effects on the intestinal microbiota of a prebiotic-supplemented milk formula after an antibiotic treatment . A r and omized , double-blind , controlled clinical trial was carried out in 140 infants 1–2 y of age distributed into two groups after a 1-wk amoxicillin treatment ( 50 mg/kg/d ) for acute bronchitis . The children received for 3 wk > 500 mL/d of a formula with prebiotics ( 4.5 g/L ) or a control without prebiotics . Fecal sample s were obtained on d –7 ( at the beginning of the antibiotic treatment ) , on d 0 ( end of the treatment and before formula administration ) , and on d 7 and 21 ( during formula administration ) . Counts of Bifidobacterium , Lactobacillus-Enterococcus , Clostridium lituseburiense cluster , Clostridium histolyticum cluster , Escherichia coli , and Bacteroides-Prevotella were evaluated by fluorescent in situ hybridization ( FISH ) and flow cytometry . Tolerance and gastrointestinal symptoms were recorded daily . Amoxicillin decreased total fecal bacteria and increased E. coli . The prebiotic significantly increased bifidobacteria from 8.17 ± 1.46 on d 0 to 8.54 ± 1.20 on d 7 compared with the control 8.22 ± 1.24 on d 0 versus 7.95 ± 1.54 on d 7 . The Lactobacillus population showed a similar tendency while the other bacteria were unaffected . No gastrointestinal symptoms were detected during the prebiotic administration . Prebiotics in a milk formula increase fecal bifidobacteria early after amoxicillin treatment without inducing gastrointestinal symptoms ",
"Objectives : To come even closer to the functional composition of human milk , acidic oligosaccharides ( AOS ) from pectin were added to well known neutral prebiotics ( galacto-oligosaccharides ( GOS ) and long-chain fructo-oligosaccharides ( FOS ) ) . The effect of AOS and GOS/FOS/AOS on intestinal flora , stool characteristics as well as acceptance and tolerance was investigated . Methods : Human milk contains 75 % to 85 % neutral and 15 % to 25 % acidic oligosaccharides . In this prospect i ve , r and omized , double blind study , a mixture of 80 % neutral oligosaccharides ( from long-chain galacto- and long-chain fructo-oligosaccharides ) with 20 % acidic oligosaccharides derived from pectin hydrolysis was investigated . Forty-six term infants were fed a st and ard formula supplemented with either maltodextrin as control ( n = 15 ) , or with 0.2 g acidic oligosaccharides ( n = 16 ) , or with the latter plus 0.6 g neutral oligosaccharides ( mixture of galacto- and fructo-oligosaccharides ; n = 15 ) . Fecal flora using plating technique and pH were measured . Stool characteristics and possible side effects ( crying , vomiting , and regurgitation ) were recorded . Results : There was no difference in the bifidobacteria counts between the control and the group supplemented with acidic oligosaccharides alone ( 8.75 ± 0.50 vs. 8.58 ± 0.94 log colony forming units [CFU]/g stool ) . In infants fed the combination of acidic and neutral oligosaccharides , bifidobacteria were increased ( 9.61 ± 0.70 log CFU/g stool ; P . Stool consistency was softest in infants fed the complete oligosaccharide mixture , but also in those fed formula supplemented with acidic oligosaccharides alone , the stool consistency was significantly softer compared with the control group . Fecal pH increased in the controls , remained constant in acidic oligosaccharides alone , and decreased in the complete mixture of oligosaccharides group . Conclusion : There was no difference in growth , crying , vomiting , and regurgitation patterns between the groups . In summary , acidic oligosaccharides from pectin hydrolysate are well tolerated as ingredient in infant formulae but do not affect intestinal microecology",
"Background : The establishment of a balanced intestinal microflora which may protect against infection is desirable for the preterm infant . Objective : To investigate the effect of a preterm formula milk supplement consisting of oligosaccharides in similar proportions to human milk on the faecal flora and stool characteristics of preterm infants . Study design : To resemble the effect of human milk , an oligosaccharide mixture consisting of 90 % galacto-oligosaccharides and 10 % fructo-oligosaccharides was used to supplement a st and ard preterm formula at a concentration of 10 g/l . This supplemented formula was studied in 15 preterm infants , and the results were compared with those found in 15 infants fed a formula supplemented with maltodextrin as placebo . A group fed fortified mother 's milk was investigated as a reference group ( n = 12 ) . On four days during a 28 day feeding period ( 1 , 7 , 14 , and 28 ) , the faecal flora was investigated , and stool characteristics , growth , and possible side effects were recorded . Results : During the study period , the number of bifidobacteria in the group fed the oligosaccharide supplemented formula increased to the upper range of bifidobacteria counts in the reference group . The difference between the supplemented and non-supplemented groups was highly significant ( p = 0.0008 ) . The stool characteristics were also influenced by the supplement : the stool frequency after 28 days was significantly lower in the control group than in the oligosaccharide supplemented group ( p = 0.0079 ) and the reference group ( p stool consistency in the control group became harder , but remained fairly stable in the other two groups . There was no effect of the different diets on the incidence of side effects ( crying , regurgitation , vomiting ) or on weight gain or length gain . Conclusion : Supplementing preterm formula with a mixture of galacto- and fructo-oligosaccharides at a concentration of 10 g/l stimulates the growth of bifidobacteria in the intestine and results in stool characteristics similar to those found in preterm infants fed human milk . Therefore prebiotic mixtures such as the one studied may help to improve intestinal tolerance to enteral feeding in preterm infants",
"AIM To investigate the effect of a new infant formula supplemented with a low level ( 0.24 g/100 mL ) of galacto-oligosaccharide ( GOS ) on intestinal micro-flora ( Bifidobacteria , Lactobacilli and E. coli ) and fermentation characteristics in term infants , compared with human milk and a st and ard infant formula without GOS . METHODS Term infants ( n = 371 ) were approached in this study in three hospitals of China . All infants started breast-feeding . Those who changed to formula-feeding within 4 wk after birth were r and omly assigned to one of the two formula groups . Growth and stool characteristics , and side effects that occurred in recruited infants were recorded in a 3-mo follow-up period . Fecal sample s were collected from a sub population of recruited infants for analysis of intestinal bacteria ( culture technique ) , acetic acid ( gas chromatography ) and pH ( indicator strip ) . RESULTS After 3 mo , the intestinal Bifidobacteria , Lactobacilli , acetic acid and stool frequency were significantly increased , and fecal pH was decreased in infants fed with the GOS-formula or human milk , compared with those fed with the formula without GOS . No significant differences were observed between the GOS formula and human milk groups . Supplementation with GOS did not influence the incidence of crying , regurgitation and vomiting . CONCLUSION A low level of GOS ( 0.24 g/100 mL ) in infant formula can improve stool frequency , decrease fecal pH , and stimulate intestinal Bifidobacteria and Lactobacilli as in those fed with human milk",
"This study was conducted at Pakkred Babies Home , Bangkok , Thail and ; with the hypothesis that children receiving probiotic-supplemented milk-based formula may be protected from developing diarrheal diseases . Salivary rotavirus-specific IgA antibody was used as an indicator of rotavirus infection . One hundred and seventy-five children , aged 6 - 36 months , were enrolled in the study . They were divided into 3 groups according to the type of formula given . There were 81 episodes of diarrhea during an 8-month study period , most of which were caused by bacterial enteropathogens . Ninety-seven pairs of salivary sample s were adequate for the analysis of rotavirus antibody . Among 23 children receiving milk-based follow-up formula and serving as control group , 30.4 per cent of them had > or = 4-fold increase in the antibody titre , indicating sub clinical rotavirus infection . The majority of children in the other 2 study groups , receiving the same formula supplemented with either Bifidobacterium Bb12 alone or together with Streptococcus thermophilus , had no significant change in the antibody titres between the two time points . The results of this study support our hypothesis that children receiving bifidobacteria-supplemented milk-based formula may be protected against symptomatic rotavirus infection",
"Objectives : The intestinal flora of breast-fed infants is generally dominated by Bifidobacteria . We aim ed to investigate whether an infant formula supplemented with galacto-oligosaccharides and fructo-oligosaccharides ( GOS/FOS ) is able to establish a bifido-dominant microflora , not only in numbers but also with respect to the metabolic activity in the colon . Methods : Two groups of infants fed infant formula with 0.8 g/100 ml GOS/FOS in a ratio of 9:1 ( OSF group ) , or control formula ( SF group ) were evaluated in a r and omised , double blind , placebo controlled intervention study . A breast-fed group was studied in parallel . At study onset and after 4 and 6 weeks , faecal sample s were examined for the number of bifidobacteria , pH , short chain fatty acids and lactate . Results : After 6 weeks , the mean proportion of bifidobacteria was significantly higher in the OSF group ( 59.6 % versus 49.5 % in the SF group ; P stool mean pH and an increased proportion of acetate and a decreased proportion of propionate . The mean pH in the OSF and SF groups were 5.7 and 6.3 , respectively ( P GOS/FOS mixture to an infant formula has a stimulating effect on the growth of bifidobacteria and on the metabolic activity of the total intestinal flora . The changes in short chain fatty acids , lactate and pH in the prebiotic group represent a fermentation profile that is closer to that observed in breast-fed infants compared to infants fed control formula",
"AIM The intestinal flora of breast-fed infants is generally dominated by bifidobacteria which have beneficial properties . Their presence is due to various components of breast milk , including prebiotic substances . This prospect i ve double-blind study compared the numbers of bifidobacteria in the stool flora of bottle-fed preterm infants r and omized to receive for 14 days either a formula with prebiotic fructo-oligosaccharides at a concentration of 0.4 g/dL or the same formula with maltodextrin as a placebo . METHODS Within 0 - 14 days after birth , 56 healthy bottle-fed infants were enrolled to receive either the prebiotic or placebo . Faecal sample s were taken at inclusion day and at study day 7 . The number of bifidobacteria in the stools , stool characteristics and somatic growth were recorded during the study . RESULTS In the group fed fructo-oligosaccharides , both the numbers of bifidobacteria in the stools and the proportion of infants colonized with them were significantly higher as compared to the placebo group ( p=0.032 and p=0.030 respectively ) . There was also a higher number of bacteroids in the fructo-oligosaccharide group as compared to the placebo ( p=0.029 ) . At the same time , reduction was noted in the numbers of Escherichia coli and enterococci . ( p=0.029 , and p=0.025 , respectively ) . Supplementation had also significant influence on stool frequency per day ( p=0.0080 ) . CONCLUSION An infant formula containing a small quantity of prebiotic oligosaccharides is well accepted and leads to rapid growth of bifidobacteria in the gut of bottle-fed preterm infants while decreasing the numbers of pathogenic microorganisms",
"Objectives Probiotics may be useful in preventing acute infectious diarrhea . Bifidobacteria are particularly attractive as probiotics agent because they constitute the predominant colonic flora of breastfed infants and are thought to play a role in the decreased incidence of diarrhea in breastfed infants . Methods This was a multicenter , double-blind , controlled study to evaluate the efficacy of a milk formula supplemented with viable Bifidobacterium lactis strain Bb 12 ( BbF ) in the prevention of acute diarrhea in infants younger than 8 months living in residential nurseries or foster care centers . Results Ninety healthy children received either the BbF or a conventional formula ( CF ) daily . The mean duration of the stay in the residential center was similar ( 137 v 148 days ) . At enrollment , there were no differences between the two groups with respect to age ( 3.7 ± 2.1 months ) , gender , anthropometric data , history of allergy or gastrointestinal disease , frequency of breast-feeding in the neonatal period or timing of introduction of solid food . Altogether , 28.3 % of the BbF infants had diarrhea during the study compared with 38.7 % of controls ( NS ) . There was a statistically insignificant trend for shorter episodes of diarrhea in the BbF group ( 5.1 ± 3.3 days v 7 ± 5.5 days , NS ) . The number of days with diarrhea was 1.15 ± 2.5 in the BbF group with a daily probability of diarrhea of 0.84 versus 2.3 ± 4.5 days and 1.55 , respectively , in the CF group ( P = 0.0002 and 0.0014 ) . Feeding infants with the BbF reduced their risk of getting diarrhea by a factor of 1.9 ( range , 1.33–2.6 ) . Analysis of the cumulative incidence of diarrheal episodes showed a trend that the first onset of diarrhea occurred later in the BbF group . Conclusion These results provide some evidence that viable Bifidobacterium lactis strain Bb 12 , added to an acidified infant formula , has some protective effect against acute diarrhea in healthy children",
"Objective : To compare the safety and tolerance of two formulas , supplemented with different probiotic agents , in early infancy . Design : Prospect i ve r and omized placebo-controlled trial . Setting : Clinics of a University Medical Center . Subjects : Full-term healthy infants aged less than 4 months . Intervention : Infants were r and omly assigned for 4 weeks to a st and ard milk-based formula supplemented with either Bifidobacterium lactis ( BB-12 ) , Lactobacillus reuteri ( ATCC 55730 ) or a probiotics-free formula . Measures of Outcome : Growth parameters , daily characteristics of feeding , stooling and behavior , and side effects . Results : Fifty-nine infants , aged 3–65 days , were included . Subjects in all three groups were similar at entry in terms of gestational age , birth weight , sex , growth parameters and breast feeding rate prior to the study . The supplemented formulas were well accepted and did not reveal any adverse effects . A comparison of growth parameters , and variables of feeding , stooling and crying and irritability did not reveal any significant differences between groups . Conclusions : The use of formula supplemented with either Lactobacillus reuteri or Bifidobacterium lactis in early infancy , was safe , well tolerated and did not adversely affect growth , stooling habits or infant behavior",
"We assessed the growth , tolerance , and acceptability as well as fecal flora composition and stool pH of 20 healthy full-term infants fed with a fermented whey-adapted infant formula containing viable bifidobacteria ( 10(6)/g of powder ) during the first 2 months of life . This fermented infant formula , first biologically acidified by Streptococcus thermophilus and Lactobacillus helveticus , was compared to a whey-adapted , nonacidified , low-phosphate infant formula in a double-blind , r and omized controlled study . The results were compared to a control group ( n = 14 ) of fully breast-fed infants . The fermented whey-adapted formula containing viable bifidobacteria induced a prevalence of colonization with bifidobacteria at 1 month of age similar to that of breast-fed infants ( 12/20 versus 8/14 ) but significantly higher than in the group fed the st and ard infant formula ( 4/20 ) . The mean bacterial count of bifidobacteria was similar in all colonized infants ; however , fecal pH was significantly lower in the breast-fed infants than in the nonacidified bottle-fed infants . This kind of infant formula was well tolerated and promoted a normal growth during the first 2 months",
"AIM Effects of supplementing prebiotic oligosaccharides to formula for healthy infants were studied in this placebo controlled , r and omised , double blind study . METHODS Ninety-seven infants were included into the study ; among them 42 breast-fed infants , 14 infants fed formula supplemented with 0.4 g/100ml oligosaccharides ( 9 to 1 mixture of galacto- and fructooligosaccharides ) and 13 infants fed control formula were followed-up throughout the 12-week-long study period . The groups receiving formula were compared with statistical methods , whereas data of breast-fed infants served as reference values . RESULTS Infants fed the two formulae did not differ in nutrient intakes , growth , occurrence rate of feeding difficulties and atopic manifestations , or in calcium excretion . The intestinal flora did not differ between the two formula fed groups at the beginning of the study . In contrast , numbers of Bifidobacteriae were significantly higher in infants receiving the formula supplemented with prebiotic oligosaccharides both at the 14th day ( 9 x 1011 versus 5 x 1010 , colony forming units/g faeces , median , p infant formula with prebiotic oligosaccharides result ed in ameliorating the difference in intestinal flora between formula fed and breast-fed healthy infants",
"Goals : This clinical trial was carried out to determine whether oral treatment with a commercial probiotic formula containing Bifidobacterium lactis and Streptococcus thermophilus would reduce the frequency of antibiotic-associated diarrhea ( AAD ) in infants . Study : In this double-bind formula controlled study , 80 infants , 6 to 36 months of age , were r and omly assigned to receive a commercial formula containing 107 viable cells of B. lactis and 106viable cells of S. thermophilus at the initiation of antibiotics for a duration of 15 days . The infants were assessed daily for formula intake , stool frequency , and stool consistency for a total duration of 30 days . Seventy-seven infants received nonsupplemented formula for the entire duration . Results : There was a significant difference in the incidence of AAD in the children receiving probiotic-supplemented formula ( 16 % ) than nonsupplemented formula ( 31 % ) . Conclusions : The present study shows that prevention against AAD in infants was obtained by oral treatment with daily dose of B. lactis and S. thermophilus",
"BACKGROUND Probiotic bacteria have beneficial effects on the immune system and gastrointestinal tract , but the impacts of their long-term consumption on health and growth in early infancy are not well documented . The aim of this study was to evaluate the influence of Lactobacillus rhamnosus GG (LGG)-enriched formula on growth and faecal microflora during the first 6 months of life in normal healthy infants . MATERIAL S AND METHODS One hundred and twenty healthy infants ( up to 2 months ) received LGG-supplemented formula or regular formula in a double-blind , r and omized manner until the age of 6 months . Weight , length and head circumference were measured monthly and transformed into st and ard deviation scores ( SDS ) . Faecal sample s were obtained from a r and om sample of infants ( n=25 ) at entry and at the end of the study . RESULTS One hundred and five infants ( 51 in the LGG group ) completed the study . Children receiving LGG-supplemented formula grew better : their changes in their length and weight SDS ( DeltaSDS ) at the end of the study were significantly higher than those receiving regular formula ( 0.44+/- 0.37 versus 0.07+/- 0.06 , P defecation frequency 9.1+/-2.06 versus 8.0+/- 2.8 ( P colonization with lactobacilli was found in the LGG group , 91 % versus 76 % ( P Infants fed with LGG-enriched formula grew better than those fed with regular formula . Further studies are necessary to clarify the mechanism of LGG in infant growth",
"BACKGROUND . The value of probiotics for primary prevention is controversial . Published trials vary considerably in study design and the applied probiotics , thereby limiting comparability of the results . OBJECTIVE . The purpose of this trial was to study the preventive effect of the probiotic Lactobacillus GG on the development of atopic dermatitis . METHODS . In a double-blind , placebo-controlled prospect i ve trial , 105 pregnant women from families with ≥1 member ( mother , father , or child ) with an atopic disease were r and omly assigned to receive either the probiotic Lactobacillus GG ( American Type Culture Collection 53103 ; 5 × 109 colony-forming units of Lactobacillus GG twice daily ) or placebo . Ninety-four families ( 89.5 % ) completed the trial . The supplementation period started 4 to 6 weeks before expected delivery , followed by a postnatal period of 6 months . The primary end point was the occurrence of atopic dermatitis at the age of 2 years . Secondary outcomes were severity of atopic dermatitis , recurrent episodes of wheezing bronchitis , and allergic sensitization at the age of 2 years . RESULTS . Atopic dermatitis was diagnosed in 14 ( 28 % ) of 50 in the Lactobacillus GG group and in 12 ( 27.3 % ) of 44 in the placebo group . The risk of atopic dermatitis in children on probiotics relative to placebo was 0.96 ( confidence interval 0.38–2.33 ) . Severity of atopic dermatitis was comparable between the 2 groups . Notably , children with recurrent ( ≥5 ) episodes of wheezing bronchitis were more frequent in the Lactobacillus GG group ( 26 % ; n = 13 ) , as compared with the placebo group ( 9.1 % ; n = 4 ) . No difference was observed between both groups in total immunoglobulin E concentrations or numbers of specific sensitization to inhalant allergens . CONCLUSIONS . Supplementation with Lactobacillus GG during pregnancy and early infancy neither reduced the incidence of atopic dermatitis nor altered the severity of atopic dermatitis in affected children but was associated with an increased rate of recurrent episodes of wheezing bronchitis . Therefore , Lactobacillus GG can not be generally recommended for primary prevention",
"OBJECTIVES The larger number of bifidobacteria in the intestine of breast-fed infants has been associated with their better health compared with formula-fed infants . We assessed the safety and tolerability of an experimental formula containing 2 x 10(7 ) colony-forming units of Bifidobacterium longum BL999 and 4 g/L of a prebiotic mixture containing 90 % galacto-oligosaccharides and 10 % fructo-oligosaccharides . METHODS A 7-mo prospect i ve , r and omized , reference-controlled , double-blinded trial was performed in infants who were not breast fed after the 14th day of birth . One hundred thirty-eight infants were enrolled and assigned to receive the control or experimental formula until they were 112 d old . Mean weight gain ( primary outcome ) and recumbent length , head circumference , tolerability ( gastrointestinal symptoms ) , and overall morbidity ( secondary outcomes ) were measured at 14 , 28 , 56 , 84 , and 112 d of age . RESULTS Equivalence in mean weight gain between the two groups was shown . The treatment difference in the intention-to-treat and per- protocol population s were within the predefined equivalence boundaries of + /-3.9 g/d . No statistically significant difference in recumbent length , head circumference , or incidence of adverse events was found between the two groups . Infants in the experimental group had fewer incidences of constipation and had stool characteristics that suggest that the experimental formula was tolerated well . Furthermore , these infants showed a trend toward fewer respiratory tract infections . CONCLUSIONS The starter formula containing BL999 and galacto-oligosaccharides/fructo-oligosaccharides is safe and well-tolerated",
"The aim of the study was to evaluate whether supplementation of milk-formulas with prebiotic fructo-oligosaccharides or a probiotic , Lactobacillus johnsonii La1 ( La1 ) , could modulate the composition of the fecal microbiota of formula-fed infants , compared to breastfed ( BF ) infants . Ninety infants close to 4 months of age were r and omized into one of three groups to be blindly assigned to receive for 13 weeks : a ) an infant formula ( Control ) , b ) the same formula with fructo-oligosaccharides ( Prebio ) , or c ) with La1 ( Probio ) . At the end of this period , all infants received the control formula for 2 additional weeks . Twenty-six infants , breastfed throughout the study , were recruited to form group BF . Fecal sample s were obtained upon enrolment and after 7 and 15 weeks . Bacterial population s were assessed with classical culture techniques and fluorescent in situ hybridisation ( FISH ) . Seventy-six infants completed the study . On enrolment , higher counts of Bifidobacterium and Lactobacillus and lower counts of enterobacteria were observed in BF compared to the formula-fed infants ; these differences tended to disappear at weeks 7 and 15 . No major differences for Clostridium , Bacteroides or Enterococcus were observed between the groups or along the follow up . Probio increased fecal Lactobacillus counts ( p excreted live La1 in their stools at week 7 but only 17 % at week 15 . Increased Bifidobacterium counts were observed at week 7 in the 3 formula groups , similar to BF infants . These results confirm the presence of higher counts of bifidobacteria and lactobacilli in the microbiota of BF infants compared to formula-fed infants before dietary diversification , and that La1 survives in the infant digestive tract",
"BACKGROUND Oligosaccharides in human milk may protect infants by improving the intestinal micro-flora and fermentation . This study was to investigate effects of infant formula milk consisting of galacto-oligosaccharide ( GOS ) on intestinal microbial population s and the fermentation characteristics in term infants in comparison with that of human milk . METHODS The test formula ( Frisolac H , Friesl and , Netherl and ) was supplemented with GOS at a concentration of 0.24 g/dl . Human milk and another formula without oligosaccharides ( Frisolac H , Friesl and , Netherl and ) were used as positive and negative control respectively . Growth , stool characteristics , and side effects of the recruited infants were recorded after 3 and 6 months ' follow-up , and the fecal species were collected for the analysis of intestinal micro-flora , short chain fatty acid ( SCFA ) and pH. RESULTS At the end of 3- and 6-month feeding period , intestinal Bifidobacteria and Lactobacilli were significantly increased in infants fed with GOS supplemented formula and human milk when compared with infants fed with negative control formula ; however , there was no statistically significant difference between GOS supplemented formula and human milk groups . Stool characteristics were influenced by the supplement and main fecal SCFA ( acetic ) , and stool frequency were significantly increased in infants fed with GOS supplemented formula and human milk , while the fecal pH was significantly decreased as compared with that of negative control ( P incidence of side effects ( including crying , regurgitation and vomiting ) . CONCLUSIONS Supplementing infant formula with GOS at a concentration of 0.24 g/dl stimulates the growth of Bifidobacteria and Lactobacilli in the intestine and stool characteristics are similar to in term infants fed with human milk ",
"BACKGROUND The intestinal flora of breast-fed infants is generally dominated by bifidobacteria which have beneficial properties . Their presence is due to various compounds of breast milk including prebiotic substances . AIM This prospect i ve , double blind , study compared the growth , acceptability and the proportion of bifidobacteria and clostridia in the stool flora of bottle-fed infants r and omized to receive a formula with a specific mixture of 0.4 g/100 ml prebiotic galacto- and long-chain fructooligosaccharides or the same formula without added prebiotics . METHODS Within 0 - 14 days after birth at term , healthy bottle-fed infants were enrolled to receive either a prebiotic formula or a st and ard formula . At recruitment anthropometric measurements were done . These were repeated at the age of 6 and 12 weeks . Stool sample s were taken at inclusion and at the age of 6 weeks . The number of bifidobacteria and clostridia was determined by fluorescent in situ hybridization . RESULTS There was good tolerance of the prebiotic formula . Somatic growth was similar in the two groups . Stool frequency was significantly higher in the prebiotic group ( P=0.031 ) . Infants in the prebiotic group had also softer stools as compared to the control group ( P=0.026 ) . Baseline values of microorganisms at study entry were similar . The percentage of faecal clostridia at the completion of the study was significantly lower in the prebiotic group ( P=0.042 ) , while the proportion of faecal bifidobacteria was higher in the prebiotic group as compared to the control group . However this difference did not reach statistical significance ( P=0.262 ) . The percentage of E. coli was lower in the prebiotic group but again this did not reach statistical significance ( P=0.312 ) . CONCLUSION An infant formula containing prebiotic oligosaccharides is well tolerated , leads to normal somatic growth and suppresses the numbers of clostridia in the faeces with a trend for higher percentage of stool bifidobacteria and lower percentage of E. coli",
"This article by the ESPGHAN Committee on Nutrition summarizes available information on the effects of adding prebiotic oligosaccharides to infant and follow-on formulae . Currently there are only limited studies evaluating prebiotic substances in dietetic products for infants . Although administration of prebiotic oligosaccharides has the potential to increase the total number of bifidobacteria in feces and may also soften stools , there is no published evidence of clinical benefits of adding prebiotic oligosaccharides to dietetic products for infants . Data on oligosaccharide mixtures in infant formulae do not demonstrate adverse effects , but further evaluation is recommended . Combinations and dosages in addition to those so far studied need to be fully evaluated with respect to both safety and efficacy before their use in commercial infant food products . Well- design ed and carefully conducted r and omized controlled trials with relevant inclusion /exclusion criteria , adequate sample sizes and vali date d clinical outcome measures are needed both in preterm and term infants . Future trials should define optimal quantity and types of oligosaccharides with prebiotic function , optimal dosages and duration of intake , short and long term benefits and safety . At the present time , therefore , the Committee takes the view that no general recommendation on the use of oligosaccharide supplementation in infancy as a prophylactic or therapeutic measure can be made",
"A double‐blind , r and omized , controlled study was performed in 90 full term infants to evaluate dose‐related bifidogenic effects of a new synergistic mixture of galacto‐oligosaccharides ( GOS ) and fructo‐oligosacharides ( FOS ) . The GOS/FOS mixture showed a dose‐dependent stimulatory effect on the intestinal growth of bifidobacteria . Also stool consistency and faecal pH were positively affected",
"Objectives : The present study was design ed to evaluate the effect of 2 different combinations of prebiotic ingredients , polydextrose ( PDX ) , galactooligosaccharides ( GOS ) , and lactulose ( LOS ) , at 2 different intake levels on the overall growth and tolerance in healthy term infants up to 120 days of age . Patients and Methods : Healthy , formula-fed , term infants ( n = 226 ) were r and omly assigned to 1 of 3 study formula groups : control group ( n = 76 ) , PG4 group ( control formula supplemented with 4 g/L of a prebiotic blend , n = 74 ) , or PGL8 group ( control formula supplemented with 8 g/L of a prebiotic blend , n = 76 ) . Anthropometric measurements were taken at 14 , 30 , 60 , 90 , and 120 days of age , and 24-hour dietary recall and 24-hour tolerance recall were recorded at 30 , 60 , 90 , and 120 days of age . Adverse events were recorded throughout the study . Results : There were no statistically significant differences among the 3 formula groups for weight growth rate or length growth rate at any time point . Significant differences in stool consistency were detected among the 3 formula groups at 30 , 60 , and 90 days of age ( P looser stools than the control group . The PGL8 group had significantly higher stool frequency compared with the control and PG4 groups at 30 days of age ( P = 0.021 and P = 0.017 , respectively ) , but all of the groups were similar at 60 , 90 , and 120 days of age . A statistical difference was detected among the formula groups in 3 categories of adverse events : diarrhea ( control vs PG4 , 4 % vs 18 % , P = 0.008 ) , eczema ( PG4 vs control , 18 % vs 7 % , P = 0.046 ; PG4 vs PGL8 , 18 % vs 4 % , P = 0.008 ) , and irritability ( control vs PGL8 , 4 % vs 16 % , P = 0.027 ) . Conclusions : Infants fed formula supplemented with a prebiotic mixture achieved normal growth and stool characteristics more similar to those of breast-fed infants in comparison with infants fed an unsupplemented formula . A pediatrician needs to consider the risk of possible intolerance against the benefits of prebiotics",
"Acute diarrhea is a common cause of infant morbidity and mortality . Probiotic supplemented infant formula is one of the effective methods for prevention of rotavirus diarrhea . Other benefits of the probiotics supplemented formula were evaluated by monitoring the growth of the children . A double-blind , placebo-controlled trial was done in 148 children aged 6 - 36 months . They were divided into 3 groups : the Bb12 group , 51 children received infant formula with Bifidobacteria Bb12 supplement ; the Bb12+ST group , 54 children received infant formula with Bb12 and Streptococcus thermophilus supplement ; and the control group , 43 children received infant formula without supplement . The mean weight Z-score according to WHO reference st and ard of the Bbl2 group was -1.8 + /- 0.12 , the Bb12+ST group was -1.4 + /- 0.11 and the control group was -1.8 + /- 0.13 at entry . The mean weight Z-score of children after 6 month showed that the children in the Bbl2+ST group had the highest increase in weight which was increased from -1.4 + /- 0.11 to -0.9 + /- 0.12 compared to the Z-score of the Bb12 group which had increased from -1.8 + /- 0.12 to -1.2 + /- 0.13 and in the control group from -1.8 + /- 0.13 to -1.7 + /- 0.25 . In terms of the mean height Z-score , the Bb12 group was -2.7 + /- 0.14 to -1.7 + /- 0.16 which was higher than the Bb12+ST group ( - 2.2 + /- 0.13 to -1.7 + /- 0.13 ) but was not different from the control group . However , the mean weight/height Z-score of the Bbl2+ST group had approached the reference st and ard ( Bb12 group -0.1 + /- 0.11 to -0.1 + /- 0.13 , Bb12+ST group -0.1 + /- 0.10 to 0.3 + /- 0.17 , control group -0.4 + /- 0.12 to -0.1 + /- 0.16 ) . Data showed that children who received the probiotics supplement formula had better growth during the 6 month period ",
"Secretory immunoglobulin A ( SIgA ) plays an important role in the defence of the gastrointestinal tract . The level of faecal SIgA antibody is associated with increased neutralization and clearance of viruses . Formula-fed infants who lack the transfer of protective maternal SIgA from breast milk may benefit from strategies to support maturation of humoral immunity and endogenous production of SIgA. We aim ed at study ing the effects of st and ard , prebiotic and probiotic infant formulas on the faecal SIgA levels . At birth , infants of whom the mother had decided not to breastfeed were allocated to one of three formula groups in a r and omized , double-blind fashion . Nineteen infants received st and ard infant formula ; 19 received prebiotic formula containing a specific mixture of 0.6 g galacto-oligosaccharides (GOS)/fructo-oligosaccharides (FOS)/100 ml formula and 19 received probiotic formula containing 6.0 x 10(9 ) cfu Bifidobacterium animalis/100 ml formula . Faecal sample s were taken on postnatal day 5 , day 10 , wk 4 and every 4 wk thereafter until wk 32 . SIgA in faeces was determined by an enzyme-linked immunosorbent assay . During the intervention , infants fed on prebiotic formula showed a trend towards higher faecal SIgA levels compared with the st and ard formula-fed infants reaching statistical significance at the age of 16 wk . In contrast , infants fed on the probiotic formula showed a highly variable faecal SIgA concentration with no statistically significant differences compared with the st and ard formula group . Formula-fed infants may benefit from infant formulas containing a prebiotic mixture of GOS and FOS because of the observed clear tendency to increase faecal SIgA secretion . Adding viable B. animalis strain Bb-12 to infant formula did not reveal any sign for such a trend",
"Objective : To test the safety and effect on faecal microbiota of a formula with prebiotic oligosaccharides alone or in combination with acidic oligosaccharides in infants at the age of partial formula feeding . Patients and Methods : The study was a double-blind , placebo-controlled , r and omised intervention trial in which 82 healthy , full-term , partially breast-fed children , from 1 week to 3 months old , were given 1 of the following formulae : whey-based formula ( control group ) , whey-based formula with galacto- and long-chain fructo-oligosaccharides ( scGOS/lcFOS group ) , or whey-based formula with galacto- and long-chain fructo-oligosaccharides added with pectin-derived acidic oligosaccharides ( scGOS/lcFOS/pAOS group ) . Children were studied for the duration of the partial formula feeding period and every 2 weeks for 2 months after breast-feeding cessation . The total bacteria count and the proportion of 7 bacterial families were determined using in situ hybridisation coupled to flow cytometry . Results : The total bacterial count did not alter with time or type of feeding ( 9.9 ± 0.1 log10 cells per gram wet weight ) . Compared with the control group , there was an increase of the Bifidobacterium genus ( P = 0.0001 ) , and a decrease of proportions for the Bacteroides group ( P = 0.02 ) and the Clostridium coccoides group ( P = 0.01 ) in both oligosaccharide groups . The proportion of bifidobacteria was significantly higher in the scGOS/lcFOS/pAOS compared with the scGOS/lcFOS group ( P < 0.01 ) . Conclusions : Infant formulae appear to be clinical ly safe and effective on infant microbiota . They minimize the alteration of faecal microbiota after cessation of breast-feeding and promote bifidobacteria proportions , with a stronger effect when acidic oligosaccharides are present",
"OBJECTIVE . Live probiotic bacteria and dietary prebiotic oligosaccharides ( together termed synbiotics ) increasingly are being used in infancy , but evidence of long-term safety is lacking . In a r and omized , placebo-controlled , double-blind trial , we studied the safety and long-term effects of feeding synbiotics to newborn infants . METHODS . Between November 2000 and March 2003 , pregnant mothers carrying infants at high risk for allergy were r and omly assigned to receive a mixture of 4 probiotic species ( Lactobacillus rhamnosus GG and LC705 , Bifidobacterium breve Bb99 , and Propionibacterium freudenreichii ssp shermanii ) or a placebo for 4 weeks before delivery . Their infants received the same probiotics with 0.8 g of galactooligosaccharides , or a placebo , daily for 6 months after birth . Safety data were obtained from clinical examinations and interviews at follow-up visits at ages 3 , 6 , and 24 months and from question naires at ages 3 , 6 , 12 , and 24 months . Growth data were collected at each time point . RESULTS . Of the 1018 eligible infants , 925 completed the 2-year follow-up assessment . Infants in both groups grew normally . We observed no difference in neonatal morbidity , feeding-related behaviors ( such as infantile colic ) , or serious adverse events between the study groups . During the 6-month intervention , antibiotics were prescribed less often in the synbiotic group than in the placebo group ( 23 % vs 28 % ) . Throughout the follow-up period , respiratory infections occurred less frequently in the synbiotic group ( geometric mean : 3.7 vs 4.2 infections ) . CONCLUSION . Feeding synbiotics to newborn infants was safe and seemed to increase resistance to respiratory infections during the first 2 years of life",
"Background / Aims : Supplementation with certain probiotics can improve gut microbial flora and immune function but should not have adverse effects . This study aim ed to assess the risk of D-lactate accumulation and subsequent metabolic acidosis in infants fed on formula containing Lactobacillus johnsonii ( La1 ® ) . Methods : In the framework of a double-blind , r and omized controlled trial enrolling 71 infants aged 4–5 months , morning urine sample s were collected before and 4 weeks after being fed formulas with or without La1 ( 1 × 108/g powder ) or being breastfed . Urinary D- and L-lactate concentrations were assayed by enzymatic , fluorimetric methods and excretion was normalized per mol creatinine . Results : At baseline , no significant differences in urinary D-/L-lactate excretion among the formula-fed and breastfed groups were found . After 4 weeks , D-lactate excretion did not differ between the two formula groups , but was higher in both formula groups than in breastfed infants . In all infants receiving La1 , urinary D-lactate concentrations remained within the concentration ranges of age-matched healthy infants which had been determined in an earlier study using the same analytical method . Urinary L-lactate also did not vary over time or among groups . Conclusions : Supplementation of La1 to formula did not affect urinary lactate excretion and there is no evidence of an increased risk of lactic acidosis",
"OBJECTIVE Cholesterol is a nutrient of essential importance in infant feeding because it is necessary in membrane development . In adults with high lipid levels , high doses of inulin ( oligofructose ) inconsistently decreased levels of serum cholesterol . The aim of the present study was to evaluate cholesterol and triacylglycerol levels in infants receiving a formula with a specific mixture of 0.6 g/100 mL of galacto-oligosaccharides ( GOS ) and long-chain fructo-oligosaccharides ( lcFOS ) in a ratio of 9/1 , a control formula , or breast milk . Because the level of lcFOS in the infant milk is low , we hypothesized that there would be no differences between the formula groups . METHODS Two hundred fifteen infants were included in a prospect i ve , r and omized , double-blinded , placebo-controlled trial during the first 6 mo of life . Formula-fed infants were r and omized to receive a st and ard infant formula with a specific mixture of 0.6 g/100 mL of GOS/lcFOS , in a ratio of 9/1 , or a control formula . Breast-fed infants were r and omized to receive one of these two formulas after the mother had decided to discontinue breastfeeding . Serum levels of cholesterol , high-density lipoprotein , low-density lipoprotein ( LDL ) , and triacylglycerol were determined at 8 and 26 wk of age and were provided for infants who received the GOS/lcFOS formula or control formula from birth or after cessation of breastfeeding and for the subgroups that were fully fed with breast milk and formula . RESULTS One hundred eighty-seven infants completed the study . Total cholesterol and LDL levels at 8 and 26 wk were significantly lower in the formula-fed groups than in the breast-fed infants . There were no significant differences between the formula-fed groups . Levels of triacylglycerols and high-density lipoprotein did not differ between groups . CONCLUSION Our study demonstrated no differences in total cholesterol and LDL cholesterol in infants receiving an infant formula with GOS/lcFOS from infants receiving a control infant formula . Furthermore , total cholesterol and LDL cholesterol levels were higher in breast-fed infants than in formula-fed infants",
"Acute diarrhoea is a serious cause of infant morbidity and mortality , and the development of preventive measures remains an important goal . Bifidobacteria ( which constitute the predominant intestinal flora of breastfed infants ) , as well as other lactic-acid-producing organisms such as Streptococcus thermophilus , are thought to have a protective effect against acute diarrhoeal disease . However , their efficacy has not been assessed in controlled trials . In a double-blind , placebo-controlled trial , infants aged 5 - 24 months who were admitted to a chronic medical care hospital were r and omised to receive a st and ard infant formula or the same formula supplemented with Bifidobacterium bifidum and S thermophilus . Patients were evaluated daily for occurrence of diarrhoea , and faecal sample s , obtained weekly , were analysed for rotavirus antigen by enzyme immunoassay . Faecal sample s were also obtained during an episode of diarrhoea for virological and bacteriological analyses . 55 subjects were evaluated for a total of 4447 patient-days during 17 months . 8 ( 31 % ) of the 26 patients who received the control formula and 2 ( 7 % ) of 29 who received the supplemented formula developed diarrhoea during the course of the study ( p = 0.035 , Fisher 's exact test , two-tailed ) . 10 ( 39 % ) of the subjects who received the control formula and 3 ( 10 % ) of those who received the supplemented formula shed rotavirus at some time during the study ( p = 0.025 ) . The supplementation of infant formula with B bifidum and S thermophilus can reduce the incidence of acute diarrhoea and rotavirus shedding in infants admitted to hospital",
"Healthy , term infants received extensively hydrolyzed casein formula ( EHF ; control ) , the same formula supplemented with Lactobacillus rhamnosus GG ( EHF-LGG ) , or partially hydrolyzed whey : casein ( 60:40 ) formula supplemented with LGG ( PHF-LGG ) , in this double-blind , r and omized , controlled , parallel , prospect i ve study . Anthropometric measures and 24-hour dietary and tolerance recalls were obtained at 30 , 60 , 90 , 120 , and 150 days of age . Blood collected in a subset of infants was analyzed for fatty acid profiles in plasma and red blood cells and for markers of allergic sensitization . Adverse events were recorded throughout the study . Growth rates were not statistically different between EHF and PHF-LGG and between EHF and EHF-LGG from day 14 to day 30 , 120 , or 150 . No relevant differences in formula tolerance , adverse events , or allergic and immune markers were demonstrated between groups . The extensively and partially hydrolyzed formulas supplemented with LGG support normal growth in healthy , term infants and are well tolerated and safe",
"OBJECTIVE Intestinal microbiota plays an important role in the prevention of certain diseases during the pediatric years . Thus , there is an increasing interest in the addition of probiotics to infant formulas . The aim of this study was to evaluate the safety of a follow-on formula with Lactobacillus salivarius CECT5713 in 6-mo-old children . METHODS The antibiotic susceptibility of L. salivarius CECT5713 was analyzed by a dilution method . A double-blinded , r and omized , placebo controlled study was performed . Children ( n = 80 ) were distributed in two groups and consumed the formula supplemented or not with probiotics ( 2 × 10(6 ) colony-forming units [cfu]/g ) during 6 mo . Fecal sample s were collected at enrollment , at 3 mo , and at the end of trial . Clinical and anthropometric evaluations were performed . Depending on the variable , one-way or two-way repeated measures analysis of variance were used for the statistical analysis . RESULTS The antibiotic susceptibility profile of the strain result ed as safe . No adverse effects associated with the consumption of the probiotic formula were reported . In addition , clinical parameters did not differ between groups . Consumption of the probiotic supplemented formula led to an increase in the fecal lactobacilli content ( 7.6 ± 0.2 versus 7.9 ± 0.1 log cfu/g , P ) . Lactobacillus salivarius CECT5713 was detected in the feces of volunteers from the probiotic group . Probiotic consumption induced a significant increase in the fecal concentration of butyric acid at 6 mo . CONCLUSION Thus , a follow-on formula with L. salivarius CECT5713 is safe and well tolerated in 6-mo-old infants"
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4117fc1c-06ff-11f0-808a-c43d1ab1c353
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Abstract Fermented formulas , i.e. , those fermented with lactic acid-producing bacteria during the production process and not containing significant amounts of viable bacteria in the final product , are widely available in many countries . Our aim was to systematic ally review published evidence related to the safety and health effects of the administration of fermented infant formulas compared with st and ard infant formulas . The Cochrane Library , MEDLINE , and EMBASE data bases and major pediatric conference proceedings were search ed . Five r and omized controlled trials ( RCTs ) involving 1326 infants met the inclusion criteria . Compared with st and ard formula , the use of fermented formula result ed in a similar weight gain and length gain during the study period . Data from one RCT , albeit large , suggest the effectiveness of fermented formula in preventing and treating acute diarrhea . Fermented formula has the potential to reduce some , albeit not well-defined , digestive symptoms . Current evidence does not support the use of fermented formula for preventing cow ’s milk allergy . Conclusion : Limited available evidence suggests that the use of fermented infant formula , compared with the use of st and ard infant formula , does not offer clear additional benefits , although some benefit on gastrointestinal symptoms can not be excluded . What is known• Fermented formulas , i.e. , those fermented with lactic acid-producing bacteria during the production process and not containing significant amounts of viable bacteria in the final product , are widely available in many countries . What is new• Limited evidence available suggests that the use of fermented infant formula , compared with the use of st and ard infant formula , does not offer clear additional benefits , although some benefit on gastrointestinal symptoms can not be excluded . At the same time , no negative health effects have been documented
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"To investigate the effects of fermented formula ( FF ) with Bifidobacterium breve C50 and Streptococcus thermophilus 065 on thymus size and stool pH of healthy term infants , ultrasound examinations and evaluations of thymus sizes and thymus indices ( TI ) and measurements of stool pH were performed in the same 90 term neonates on the 3rd d of life and on the 1st , 2nd , 3rd , and 4th mo of life . Thirty newborns were exclusively breast-fed while the remaining 60 were r and omly assigned to receive either a FF or a st and ard formula ( SF ) . The fecal pH of the breast-fed group was lower than the SF group ( p difference in TI was statistically significant over repeated measurements among the groups . The FF infants showed a TI similar to the breast-fed newborns . Probiotic fermentation products have effects comparable to those of the bacteria composing the intestinal microflora supporting the idea that intestinal bacterial balance plays an important role in improving host immune responses",
"To determine whether the size of the intestinal bifidobacterial population can influence the immune response to poliovirus vaccination in infants , we set up a r and omized , placebo-controlled trial . From birth to 4 mo , infants were given a fermented infant formula ( FIF ) or a st and ard formula ( placebo ) . Bifidobacteria were quantified monthly in infant stools . Antipoliovirus IgA response to Pentacoq ® was assessed before and 1 mo after the second vaccine injection . Thirty infants were r and omized , and 20 completed the study ( nine in the placebo group and 11 in the FIF group ) . Fecal bifidobacterial level was significantly higher with the FIF group at 4 mo of age ( p = 0.0498 ) . Furthermore , B. longum/B. infantis carriage was higher at 4 mo in the FIF group ( p = 0.0399 ) . Antipoliovirus IgA titers increased after Pentacoq ® challenge ( p ( p 0.02 ) . Antibody titers correlated with bifidobacteria , especially with B. longum/B. infantis and B. breve levels ( p Infants who harbored B. longum/B. infantis also exhibited higher levels of antipoliovirus IgAs ( p that antipoliovirus response can be triggered with a fermented formula that is able to favor intestinal bifidobacteria . Whether this effect on the immune system is achieved through the bifidogenic effect of the formula ( mainly through B. longum/B. infantis and B. breve stimulation ) or directly linked to compounds ( i.e. peptides ) produced by milk fermentation remains to be investigated",
"Background : Calprotectin , a major component of soluble cytosolic proteins in human neutrophil granulocytes , is excreted in excess in stools during inflammatory bowel disease in adults and children . Faecal calprotectin concentrations are also higher during the first year of life than in adults . Objectives : To measure faecal calprotectin concentrations in the neonatal period and define reference values according to the mode of feeding : st and ard infant formula , prebiotic infant formula ( Calisma , Blédina SA , France ) , or breast feeding . Patients and methods : A prospect i ve study was carried out over three months in 69 full term , healthy newborns with a median gestational age of 39.8 weeks ( range 37–41.5 ) and a birth weight of 3300 g ( range 2600–4460 ) . Three groups were formed depending on the mode of feeding : group 1 ( n = 18 ) received a st and ard infant formula , group 2 ( n = 19 ) the prebiotic infant formula , and group 3 ( n = 32 ) was breast fed . One stool sample was taken from each newborn on day 4 ( 3–7 ) , and faecal calprotectin analysed using a commercial enzyme linked immunoassay ( Calprest , Eurospital , Italy ) . Results : Faecal calprotectin concentrations ( median 167 µg/g ) were higher than reference values in healthy adults . The concentration was below the upper reference limit for adults ( 50 µg/g ) for three infants only , one fed the st and ard formula and two fed the prebiotic formula . Concentrations did not differ significantly according to method of feeding . Conclusions : Compared with healthy adults , newborns have high calprotectin concentrations in the first days of life . There is no obvious influence of the mode of feeding",
"Objective : To determine whether long-term consumption of a fermented infant formula could influence the incidence of acute diarrhea and its severity in healthy infants . Method : Nine hundred seventy-one infants , ranging in age from 4 to 6 months , were included in a r and omized , double-blind , placebo-controlled trial during a period of 5 months . They consumed daily either a fermented infant formula ( FF ) ( fermentation with Bifidobacterium breve C50 and Streptococcus thermophilus 065 ) or a st and ard infant formula ( SF ) of the same nutritional composition . Evaluation Criteria : Number and duration of acute diarrhea episodes were evaluated . Severity of the episodes was determined by the number of hospital admissions , incidence of dehydration , number of medical consultations , number of oral rehydration solution prescriptions , and number of formula switches . Results : Growth of the infants and acceptability of the formulas were identical in the two groups . Incidence , duration of diarrhea episodes , and number of hospital admissions did not differ significantly between groups . Episodes were less severe in the FF ( fermented formula ) group . There were fewer cases of dehydration 2.5%versus 6.1 % ( P = 0.01 ) , fewer medical consultations ( 46%v 56.6 % , P = 0.003 ) , fewer ORS prescriptions 41.9%v 51.9 % ( P = 0.003 ) and fewer switches to other formulas ( 59.5%v 74.9 % , P = 0.0001 ) in FF infants compared to SF . Conclusion : A fermented formula may reduce the severity of acute diarrhea among healthy young infants . This outcome may be linked to the bifidogenic effects of fermentation products and their interactions with the intestinal immune system",
"The healthy action of probiotics is not only due to their nutritional properties and their influence on the gastrointestinal environment , but also to their action on the immune system . The aim of the present study was to determine if 6 weeks of probiotic intake would be able to modulate the immune system in women who had recently delivered and were breast-feeding . The design consisted of a r and omised , controlled and double-blind nutritional intervention study with parallel groups with a sample size of 104 women . The main variable is the T helper type 1/T helper type 2 ( Th1/Th2 ) profile determined by measuring interferon-gamma ( Th1 ) and IL-4 ( Th2 ) values in peripheral blood by flow cytometry . The modifications of cytokines were evaluated in maternal milk by cytometric bead array in a flow cytometer and ELISA at three stages of breast-feeding : colostrum , early milk ( 10 d ) and mature milk ( 45 d ) . Additionally , the anthropometry and infectious and allergic episodes in the newborn were followed up throughout the first 6 months of life . After the consumption of milk fermented with Lactobacillus casei during the puerperium , we observed a nonsignificant increase in T and B lymphocytes and a significant increase in natural killer cells . A decrease in the pro-inflammatory cytokine TNF-alpha in maternal milk and fewer gastrointestinal disturbances were also observed in the breast-fed child of the mothers who consumed L. casei . The intake of milk fermented with L. casei during the lactation period modestly contributes to the modulation of the mother 's immunological response after delivery and decreases the incidence of gastrointestinal episodes in the breast-fed child",
"Background / Objectives : To determine the impact of a not hydrolyzed fermented infant formula containing heat-killed Bifidobacterium breve C50 and Streptococcus thermophilus 065 ( HKBBST ) on the incidence of allergy-like events during the first 2 years of life in children at high risk of atopy . Subjects/ Methods : This multicenter , r and omized , double-blind , controlled study included infants at high risk of atopy . Infants used HKBBST or a st and ard infant formula ( SIF ) since birth until 1 year of age , and were followed at 4 , 12 and 24 months after birth . Skin prick tests ( SPTs ) for six foods and six aeroallergens were systematic ally performed and adverse events ( AEs ) were recorded . In case of potentially allergic AE ( PAAE ) , allergy could be further tested by SPT , patch tests and quantification of specific IgEs . If cow 's milk allergy ( CMA ) was suspected , an oral challenge could also be performed . Results : The study included 129 children , 63 were r and omized to SIF , 66 to HKBBST . The use of HKBBST milk did not alter the proportion of CMA but decreased the proportion of positive SPT to cow 's milk ( 1.7 vs 12.5 % , P=0.03 ) , and the incidence of digestive ( 39 vs 63 % , P=0.01 ) and respiratory potentially allergic AEs ( 7 vs 21 % , P=0.03 ) at 12 months , and that of respiratory PAAEs at 24 months ( 13 vs 35 % , P=0.01 ) . Conclusions : HKBBST decreased the incidence of PAAEs in children with family history of atopy , during the first months of life and after the formula was stopped . Oral tolerance to cow 's milk in infants at high risk of atopy may therefore be improved using not hydrolyzed fermented formulae",
"OBJECTIVE To study the gut flora in infants who received fermented milk containing Lactobacillus casei and Streptococcus termophilus and its effect on secretory immunoglobulin levels . MATERIAL AND METHODS An experimental , r and omized , prospect i ve , parallel group study was carried out . Thirty-five infants were included ( 18 in the treatment group and 17 in the control group ) with a mean age of 2 years ( SD : 0.6 years ; range : 1 - 3 years ) . The experimental group received both fermented milk ( 0.5 l/day ) containing L. casei and S. termophilus for 6 weeks and st and ard cow 's milk for the following 6 weeks . The control group received st and ard cow 's milk ( 0.5 l/day ) for 12 weeks . Secretory IgA levels in saliva were evaluated in the experimental group at the start of the study ( baseline levels ) and 6 weeks later . In both groups , stools were collected to study gut flora at 0 , 6 and 12 week . RESULTS Secretory IgA levels significantly increased ( p = 0.0063 ) from a mean baseline value of 2.5 mg/dl to a mean of 3.4 mg/dl at 6 weeks . Gram-negative aerobic flora were decreased in the experimental group after 6 weeks compared with the control group ( p = 0.0203 ) . The number of infants with Lactobacillus spp in their gut flora was greater in the experimental group than in the control group at week 6 and this difference was statistically significant ( p = 0.028 ) at week 12 . Conclusion The present study provides evidence of L. casei survival in the gastrointestinal tract and of its effect of increasing secretory",
"The present study was design ed to determine the effects of milk composition and the influence of gastro-oesophageal reflux ( GOR ) on gastric emptying . Cineoesogastrocintigraphy ( COGS ) was performed in 201 infants between 0 - 1 year of age in order to detect GOR , and provided a means of estimation of the gastric emptying ( GE ) . Ninety infants appeared free from GOR and constituted the control group ; 111 had GOR . There infants were fed human milk or various st and ard formulae . In addition , 20 infants fed a whey-hydrolysate formula were tested . An appropriate volume of milk was marked with sulfur-colloid Tc ( 200 microcuries ) . Measurements of gastric radioactivity were made 30 min and 120 min after ingestion . For the whole population , the infants with GOR had slightly more rapid GE after 30 min ( P less than 0.05 ) , but , for the same type of milk , there was no significant difference between GOR and controls . GE did not differ with age or sex , but differed mainly according to the type of milk . In the control group , gastric residual content ( GRC ) at 120 min was 18 + /- 11 per cent with human milk ( n = 7 ) , 16 + /- 21 per cent with whey-hydrolysate formula ( n = 8) , 25 + /- 17 per cent with acidified formula ( n = 13 ) , 26 + /- 19 per cent with whey-predominant formula ( n = 22 ) , 39 + /- 17 per cent with casein-predominant formulae ( n = 20 ) , 47 + /- 19 per cent with follow-up formulae ( n = 16 ) and 55 + /- 19 per cent with cow 's milk ( n = 12 ) . ( ABSTRACT TRUNCATED AT 250 WORDS"
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4117fc94-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Atherosclerotic cardiovascular disease ( ASCVD ) is the leading cause of death and disability worldwide , yet ASCVD risk factor control and secondary prevention rates remain low . A fixed-dose combination of blood pressure- and cholesterol-lowering and antiplatelet treatments into a single pill , or polypill , has been proposed as one strategy to reduce the global burden of ASCVD . OBJECTIVES To determine the effect of fixed-dose combination therapy on all-cause mortality , fatal and non-fatal ASCVD events , and adverse events . We also sought to determine the effect of fixed-dose combination therapy on blood pressure , lipids , adherence , discontinuation rates , health-related quality of life , and costs . SEARCH METHODS We up date d our previous search es in September 2016 of CENTRAL , MEDLINE , Embase , ISI Web of Science , and DARE , HTA , and HEED . We also search ed two clinical trials registers in September 2016 . We used no language restrictions . SELECTION CRITERIA We included r and omised controlled trials of a fixed-dose combination therapy including at least one blood pressure-lowering and one lipid-lowering component versus usual care , placebo , or an active drug comparator for any treatment duration in adults 18 years old or older , with no restrictions on presence or absence of pre-existing ASCVD . DATA COLLECTION AND ANALYSIS Three review authors independently selected studies for inclusion and extracted the data for this up date . We evaluated risk of bias using the Cochrane ' Risk of bias ' assessment tool . We calculated risk ratios ( RR ) for dichotomous data and mean differences ( MD ) for continuous data with 95 % confidence intervals ( CI ) using fixed-effect models when heterogeneity was low ( I2 nine r and omised controlled trials with a total of 7047 participants and four additional trials ( n = 2012 participants ; mean age range 62 to 63 years ; 30 % to 37 % women ) were included in this up date . Eight of the 13 trials evaluated the effects of fixed-dose combination ( FDC ) therapy in population s without prevalent ASCVD , and the median follow-up ranged from six weeks to 23 months . More recent trials were generally larger with longer follow-up and lower risk of bias . The main risk of bias was related to lack of blinding of participants and personnel , which was inherent to the intervention . Compared with the comparator groups ( placebo , usual care , or active drug comparator ) , the effects of the fixed-dose combination treatment on mortality ( FDC = 1.0 % versus control = 1.0 % , RR 1.10 , 95 % CI 0.64 to 1.89 , I2 = 0 % , 5 studies , N = 5300 ) and fatal and non-fatal ASCVD events ( FDC = 4.7 % versus control = 3.7 % , RR 1.26 , 95 % CI 0.95 to 1.66 , I2 = 0 % , 6 studies , N = 4517 ) were uncertain ( low- quality evidence ) . The low event rates for these outcomes and indirectness of evidence for comparing fixed-dose combination to usual care versus individual drugs suggest that these results should be viewed with caution . Adverse events were common in both the intervention ( 32 % ) and comparator ( 27 % ) groups , with participants r and omised to fixed-dose combination therapy being 16 % ( RR 1.16 , 95 % CI 1.09 to 1.25 , 11 studies , 6906 participants , moderate- quality evidence ) more likely to report an adverse event . The mean differences in systolic blood pressure between the intervention and control arms was -6.34 mmHg ( 95 % CI -9.03 to -3.64 , 13 trials , 7638 participants , moderate- quality evidence ) . The mean differences ( 95 % CI ) in total and LDL cholesterol between the intervention and control arms were -0.61 mmol/L ( 95 % CI -0.88 to -0.35 , 11 trials , 6565 participants , low- quality evidence ) and -0.70 mmol/L ( 95 % CI -0.98 to -0.41 , 12 trials , 7153 participants , moderate- quality evidence ) , respectively . There was a high degree of statistical heterogeneity in comparisons of blood pressure and lipids ( I2 ≥ 80 % for all ) that could not be explained , so these results should be viewed with caution . Fixed-dose combination therapy improved adherence to a multidrug strategy by 44 % ( 26 % to 65 % ) compared with usual care ( 4 trials , 3835 participants , moderate- quality evidence ) . AUTHORS ' CONCLUSIONS The effects of fixed-dose combination therapy on all-cause mortality or ASCVD events are uncertain . A limited number of trials reported these outcomes , and the included trials were primarily design ed to observe changes in ASCVD risk factor levels rather than clinical events , which may partially explain the observed differences in risk factors that were not translated into differences in clinical outcomes among the included trials . Fixed-dose combination therapy is associated with modest increases in adverse events compared with placebo , active comparator , or usual care but may be associated with improved adherence to a multidrug regimen . Ongoing , longer-term trials of fixed-dose combination therapy will help demonstrate whether short-term changes in risk factors might be maintained and lead to expected differences in clinical events based on these changes
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"Background and Objectives We compared the efficacy and safety of valsartan and rosuvastatin combination therapy with each treatment alone in hypercholesterolemic hypertensive patients . Subjects and Methods Patients who met inclusion criteria were r and omized to receive 1 of the following 2-month drug regimens : valsartan 160 mg plus rosuvastatin 20 mg , valsartan 160 mg plus placebo , or rosuvastatin 20 mg plus placebo . The primary efficacy variables were change in sitting diastolic blood pressure ( sitDBP ) and sitting systolic blood pressure ( sitSBP ) , and percentage change in low-density lipoprotein-cholesterol ( LDL-C ) in the combination , valsartan , and rosuvastatin groups . Adverse events ( AEs ) during the study were analyzed . Results A total of 354 patients were screened and 123 of them were finally r and omized . Changes of sitDBP by least squares mean ( LSM ) were -11.1 , -7.2 , and -3.6 mm Hg , respectively , and was greater in the combination , as compared to both valsartan ( p=0.02 ) and rosuvastatin ( p Changes of sitSBP by LSM were -13.2 , -10.8 , and -4.9 mm Hg , and was greater in the combination , as compared to rosuvastatin ( p=0.006 ) and not valsartan ( p=0.42 ) . Percentage changes of LDL-C by LSM were -52 , -4 , and -47 % in each group , and was greater in the combination , as compared to valsartan ( p rosuvastatin ( p=0.16 ) . Most AEs were mild and resolved by the end of the study . Conclusion Combination treatment with valsartan and rosuvastatin exhibited an additive blood pressure-lowering effect with acceptable tolerability , as compared to valsartan monotherapy . Its lipid lowering effect was similar to rosuvatatin monotherapy",
"Despite race , ethnic , and regional differences in cardiovascular disease risk , many worldwide hypertension management guidelines recommend the use of the Framingham coronary heart disease ( CHD ) risk equation to guide treatment decisions . This sub analysis of the recently published CRUCIAL trial compared the treatment-related reductions in calculated CHD and stroke risk among Pacific Asian ( PA ) patients using a variety of region-specific risk assessment models . As a result , greater reductions in systolic and diastolic blood pressure , low-density lipoprotein cholesterol , and triglycerides were observed in the proactive multifactorial intervention ( PMI ) arm compared with the usual care arm at Week 52 for PA patients . The relative percentage change in 10-yr CHD risk between baseline and Week 52 in the PMI versus usual care arms was greatest using the NIPPON DATA 80 fatal CHD model ( LS [ least square ] mean difference -42.6 % ) , and similar in the SCORE fatal CHD and Framingham total CHD models ( LS mean difference -29.4 % and -30.8 % , respectively ) . The single-pill based PMI approach is consistently effective in reducing cardiovascular disease risk , evaluated using a variety of risk assessment models . ( Clinical Trials.gov registration number : NCT00407537",
"BACKGROUND Adherence to evidence -based cardiovascular ( CV ) medications after an acute myocardial infa rct ion ( MI ) is low after the first 6 months . The use of fixed-dose combinations ( FDC ) has been shown to improve treatment adherence and risk factor control . However , no previous r and omized trial has analyzed the impact of a polypill strategy on adherence in post-MI patients . OBJECTIVES The cross-sectional FOCUS ( Fixed-Dose Combination Drug for Secondary Cardiovascular Prevention ) study ( Phase 1 ) aim ed to eluci date factors that interfere with appropriate adherence to CV medications for secondary prevention after an acute MI . Additionally , 695 patients from Phase 1 were r and omized into a controlled trial ( Phase 2 ) to test the effect of a polypill ( containing aspirin 100 mg , simvastatin 40 mg , and ramipril 2.5 , 5 , or 10 mg ) compared with the 3 drugs given separately on adherence , blood pressure , and low-density lipoprotein cholesterol , as well as safety and tolerability over a period of 9 months of follow-up . METHODS In Phase 1 , a 5-country cohort of 2,118 patients was analyzed . Patients were r and omized to either the polypill or 3 drugs separately for Phase 2 . Primary endpoint was adherence to the treatment measured at the final visit by the self-reported Morisky-Green question naire ( MAQ ) and pill count ( patients had to meet both criteria for adherence at the in-person visit to be considered adherent ) . RESULTS In Phase 1 , overall CV medication adherence , defined as an MAQ score of 20 , was 45.5 % . In a multivariable regression model , the risk of being nonadherent ( MAQ adherence compared with the group receiving separate medications after 9 months of follow-up : 50.8 % versus 41 % ( p = 0.019 ; intention-to-treat population ) and 65.7 % versus 55.7 % ( p = 0.012 ; per protocol population ) when using the primary endpoint , attending the final visit with MAQ = 20 and high pill count ( 80 % to 110 % ) combined , to assess adherence . Adherence also was higher in the FDC group when measured by MAQ alone ( 68 % vs. 59 % , p = 0.049 ) . No treatment difference was found at follow-up in mean systolic blood pressure ( 129.6 mm Hg vs. 128.6 mm Hg ) , mean low-density lipoprotein cholesterol levels ( 89.9 mg/dl vs. 91.7 mg/dl ) , serious adverse events ( 23 vs. 21 ) , or death ( 1 , 0.3 % in each group ) . CONCLUSIONS For secondary prevention following acute MI , younger age , depression , and a complex drug treatment plan are associated with lower medication adherence . Meanwhile , adherence is increased in patients with higher insurance coverage levels and social support . Compared with the 3 drugs given separately , the use of a polypill strategy met the primary endpoint for adherence for secondary prevention following an acute MI . ( Fixed Dose Combination Drug [ Polypill ] for Secondary Cardiovascular Prevention [ FOCUS ] ; NCT01321255 )",
"BACKGROUND AND AIMS Patients with established coronary artery disease ( CAD ) are likely to receive a combination of aspirin , a statin , and blood pressure (BP)-lowering agents . Combining these pharmacologic agents into a cardiovascular combination pill , such as a polypill , could be considered to reduce prescription gaps and nonadherence in high-risk patients . We aim ed to evaluate the effect of the concomitant use of aspirin , a statin , and BP-lowering agent(s ) in patients with CAD on vascular morbidity and mortality in current clinical practice in an observational study to provide insights in the combination pill concept related to feasibility and applicability . METHODS In total , 2,706 patients with CAD enrolled in the Second Manifestations of ARTerial disease study were followed for the occurrence of a subsequent vascular event ( ie , myocardial infa rct ion , ischemic cerebrovascular accident , vascular death ) and all-cause mortality . The relationship between combination therapy and cardiovascular events and all-cause mortality was assessed using Cox proportional hazards regression models to calculate hazards ratios ( HRs ) with a 95 % CI . Both covariate and propensity score adjusting methods were used to reduce confounding by indication . RESULTS A combination of aspirin , a statin , and ≥1 BP-lowering agent(s ) was used by 67 % of the patients . During a median of 5.0 years ( interquartile range 2.4 - 10.2 years ) , 347 vascular events occurred and 162 patients died . Combination therapy with aspirin , statin , and ≥1 BP-lowering agent was associated with a lower risk of myocardial infa rct ion ( HR 0.68 , 95 % CI 0.49 - 0.96 ) , ischemic cerebrovascular accident ( HR 0.37 , 95 % CI 0.16 - 0.84 ) , composite vascular end point ( HR 0.66 , 95 % CI 0.49 - 0.88 ) , vascular mortality ( HR 0.53 , 95 % CI 0.33 - 0.85 ) , and all-cause mortality ( HR 0.69 , 95 % CI 0.49 - 0.96 ) compared with the absence of combination therapy , after adjusting for confounding covariates in a propensity score . The use of 1 or only 2 components of combination therapy was associated with a higher risk for cardiovascular events compared with the combined use of aspirin , a statin , and ≥1 BP-lowering agent(s ) . CONCLUSION Two-thirds of the patients with CAD use a combination of aspirin , a statin , and ≥1 BP-lowering agent(s ) , components of a cardiovascular fixed-dose combination pill . Combination therapy with these agents is associated with a lower risk of vascular events and total mortality . Although treatment effect in observational studies should be interpreted with caution , the results of this study support supposed benefits from combination therapy . However , the effect of fixed-dose combination pill on clinical outcome needs to be demonstrated in r and omized clinical trials",
"The pill burden of patients with hypertension and dyslipidemia can result in poor medication compliance . This study aim ed to evaluate the efficacy and safety of fixed-dose combination ( FDC ) therapy with olmesartan medoxomil ( 40 mg ) and rosuvastatin ( 20 mg ) in Korean patients with mild to moderate hypertension and dyslipidemia . This multicenter , r and omized , double-blind , factorial- design study included patients aged ≥20 years with mild to moderate essential hypertension and dyslipidemia . Patients were r and omly assigned to receive FDC therapy ( 40 mg olmesartan medoxomil , 20 mg rosuvastatin ) , 40 mg olmesartan medoxomil , 20 mg rosuvastatin , or a placebo . The percentage change from baseline in low-density lipoprotein cholesterol levels was compared between FDC therapy and olmesartan medoxomil , and the change from baseline in diastolic blood pressure was compared between FDC therapy and rosuvastatin 8 weeks after treatment . A total of 162 patients were included . The least square mean percentage change ( st and ard error ) from baseline in low-density lipoprotein cholesterol levels 8 weeks after treatment was significantly greater in the FDC than in the olmesartan medoxomil group ( −52.3 % [ 2.8 % ] vs −0.6 % [ 3.5 % ] , P from baseline in diastolic blood pressure 8 weeks after treatment was significantly greater in the FDC group than in the rosuvastatin group ( −10.4 [ 1.2 ] mmHg vs 0.1 [ 1.6 ] mmHg , P 50 adverse events in 41 patients ( 22.7 % ) and eight adverse drug reactions in five patients ( 2.8 % ) . The study found that FDC therapy with olmesartan medoxomil and rosuvastatin is an effective , safe treatment for patients with hypertension and dyslipidemia . This combination may improve medication compliance in patients with a large pill burden",
"Background : Notwithst and ing improving rates of hypertension control in North America , management of patients with both hypertension and dyslipidemia remains problematic . Based on evidence of improved control utilizing a simplified algorithm for management of hypertension ( STITCH ) , we question ed whether a simplified comprehensive treatment algorithm featuring initial use of single-pill combinations ( SPCs ) would improve management of participants with both hypertension and dyslipidemia . Method : We r and omized 35 primary care practice s in Ontario to either Guidelines -care ( following current Canadian guidelines ) or STITCH2-care ( following a treatment algorithm featuring SPCs ) . Practice s each enrolled up to 50 participants with at least one risk factor above target at entry based on Canadian guidelines for BP and LDL-cholesterol control . The primary endpoint was achieving targets for both hypertension and dyslipidemia control after 6 months , assessed at the practice level . Results : The primary endpoint was achieved in 31.3 % of participants in STITCH2-care practice s , compared with 28.1 % in Guidelines -care practice s , yielding a difference of 3.2 % ( P = 0.63 ) . Notably , STITCH2-care practice s had a significantly greater reduction in SBP while LDL-cholesterol reduction was only marginally greater in STITCH2 practice s. Conclusion : The STITCH2 algorithm result ed in significantly greater use of any SPC compared with Guidelines -care and greater use of the SPC of calcium channel blocker/statin . Unwillingness of the prescribing physician to advance treatment beyond a monotherapy threshold was found to be an important determinant for failing to achieve blood pressure control . In contrast , the more important determinant for failing to achieve LDL control appeared to be the unwillingness of the prescribing physician to initiate therapy with a statin",
"Background The Kanyini Guidelines Adherence with the Polypill ( Kanyini-GAP ) Study aims to examine whether a polypill-based strategy ( using a single capsule containing aspirin , a statin and two blood pressure-lowering agents ) amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline -indicated therapies , and lower blood pressure and cholesterol levels . Methods / Design The study is an open , r and omised , controlled , multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practice s and Aboriginal Medical Services , followed for an average of 18 months . The participants will be r and omised to one of two versions of the polypill , the version chosen by the treating health professional according to clinical features of the patient , or to usual care . The primary study outcomes will be changes , from baseline measures , in serum cholesterol and systolic blood pressure and self-reported current use of aspirin , a statin and at least two blood pressure lowering agents . Secondary study outcomes include cardiovascular events , renal outcomes , self-reported barriers to indicated therapy , prescription of indicated therapy , occurrence of serious adverse events and changes in quality -of-life . The trial will be supplemented by formal economic and process evaluations . Discussion The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated . Trial Registration This trial is registered with the Australian New Zeal and Clinical Trial Registry ACTRN126080005833347",
"Background The complexity of treatment regimens , costs and pill burden decrease the medication adherence and contribute to shortfall in cardiovascular preventive drug coverage . The polypill , a fixed dose combination pill of established drugs , is expected to increase adherence and reduce the costs whilst preventing major cardiovascular events ( MCVE ) . Design and methods The PolyIran trial is a pragmatic cluster r and omized trial nested within the Golestan Cohort Study ( GCS ) . Subjects were r and omized to either non-pharmacological preventive interventions alone ( minimal care arm ) or together with a polypill ( polypill arm ) comprising hydrochlorothiazide , aspirin , atorvastatin and either enalapril or valsartan . This study benefits from the infrastructure of the primary health care system in Iran and the interventions are delivered by the local auxiliary health workers ( Behvarz ) to the participants . The primary outcome of the study is the occurrence of first MCVE within five years defined as non-fatal and fatal myocardial infa rct ion , unstable angina , sudden death , heart failure , coronary artery revascularization procedures , and non-fatal and fatal stroke . Trial status From February 2011 to April 2013 , 8410 individuals ( 236 clusters ) attended the eligibility assessment . Of those , 3421 in the polypill arm and 3417 in the minimal care arm were eligible . The study is ongoing . Conclusion The infrastructure of GCS and the primary health care system in Iran enabled the conduct of this pragmatic large-scale trial . If the polypill strategy proves effective , it may be implemented to prevent cardiovascular disease in developing countries",
"Background There has been widespread interest in the potential of combination cardiovascular medications containing aspirin and agents to lower blood pressure and cholesterol ( ‘ polypills ’ ) to reduce cardiovascular disease . However , no reliable placebo-controlled data are available on both efficacy and tolerability . Methods We conducted a r and omised , double-blind placebo-controlled trial of a polypill ( containing aspirin 75 mg , lisinopril 10 mg , hydrochlorothiazide 12.5 mg and simvastatin 20 mg ) in 378 individuals without an indication for any component of the polypill , but who had an estimated 5-year cardiovascular disease risk over 7.5 % . The primary outcomes were systolic blood pressure ( SBP ) , LDL-cholesterol and tolerability ( proportion discontinued r and omised therapy ) at 12 weeks follow-up . Findings At baseline , mean BP was 134/81 mmHg and mean LDL-cholesterol was 3.7 mmol/L. Over 12 weeks , polypill treatment reduced SBP by 9.9 ( 95 % CI : 7.7 to 12.1 ) mmHg and LDL-cholesterol by 0.8 ( 95 % CI 0.6 to 0.9 ) mmol/L. The discontinuation rates in the polypill group compared to placebo were 23 % vs 18 % ( RR 1.33 , 95 % CI 0.89 to 2.00 , p = 0.2 ) . There was an excess of side effects known to the component medicines ( 58 % vs 42 % , p = 0.001 ) , which was mostly apparent within a few weeks , and usually did not warrant cessation of trial treatment . Conclusions This polypill achieved sizeable reductions in SBP and LDL-cholesterol but caused side effects in about 1 in 6 people . The halving in predicted cardiovascular risk is moderately lower than previous estimates and the side effect rate is moderately higher . Nonetheless , substantial net benefits would be expected among patients at high risk . Trial Registration Australian New Zeal and Clinical Trials Registry",
"Aims Cardiovascular fixed-dose combination pills , or polypills , may help address the widespread lack of access and adherence to proven medicines . Initiation of polypill-based care typically entails switching from current separately taken medications . Given the heterogeneity in usual care , there is interest in the impact of polypill treatment across different patterns of prior medication regimen . Methods A total of 2004 participants with established cardiovascular disease or estimated 5-year cardiovascular risk of over 15 % were r and omised to polypill-based treatment ( aspirin 75 mg , simvastatin 40 mg , lisinopril 10 mg and either atenolol 50 mg or hydrochlorothiazide 12.5 mg ) or usual care . Baseline medications were classified by potency relative to polypill components . Estimated cardiovascular risk reduction was calculated by combining risk factor changes with results seen in meta-analyses of previous r and omised trials . Results For cholesterol reduction conferred by polypills , there was a dose response across baseline statin groups , with mean low-density lipoprotein (LDL)-cholesterol differences of 0.37 , 0.22 , 0.14 and 0.07 mmol/L among patients taking no statin , less potent , equipotent and more potent statin at baseline , respectively . Similarly there were differences in mean systolic BP of 5.4 , 6.2 , 3.3 and 1.8 mmHg among patients taking 0 , 1 , 2 or 3 BP-lowering agents . Among patients taking more potent statins at baseline , there was no significant difference in LDL-cholesterol but there were benefits for BP and aspirin adherence . Similar results were seen among patients taking 3 BP-lowering agents at baseline . Switching to a polypill-based strategy result ed in estimated cardiovascular relative risk reductions across a wide range of usual care patterns of antiplatelet , statin and BP-lowering therapy prescribing . Conclusion Adherence benefits from switching to a polypill result ed in risk factor changes that were at least as good as usual care across a wide variety of treatment patterns , including equally potent or more potent regimens . The benefits of switching to polypill-based care were greatest among those stepped up from partial treatment or less potent treatment",
"Background Few trials have compared different approaches to cardiovascular disease prevention among Pacific Asian ( PA ) population s. The Cluster R and omized Usual Care versus Caduet Investigation Assessing Long-term-risk ( CRUCIAL ) trial demonstrated that a proactive multifactorial intervention ( PMI ) approach ( based on single-pill amlodipine/atorvastatin ) result ed in a greater reduction in calculated Framingham 10-year coronary heart disease ( CHD ) risk compared with usual care ( UC ) among hypertensive patients with additional risk factors . One-third of CRUCIAL patients resided in the PA region . The aim of this sub analysis was to compare two approaches to cardiovascular risk factor management ( PMI versus UC ) among patients residing in PA and non-PA regions . Methods This sub analysis of the CRUCIAL trial compared treatment-related changes in calculated CHD risk among patients residing in PA and non-PA regions . Sensitivity analyses were conducted among men and women and those with and without diabetes . Results Overall , 448 patients ( 31.6 % ) resided in the PA region and 969 patients ( 68.4 % ) resided in non-PA regions . The PMI approach was more effective in reducing calculated CHD risk versus UC in both PA ( −37.1 % versus −3.5 % ; P PA patients had slightly greater reductions in total cholesterol compared with non-PA patients . PA patients without diabetes had slightly greater reductions in CHD risk compared with non-PA patients . Treatment effects were similar in men and women and those with diabetes . Conclusion The PMI approach was more effective in reducing calculated Framingham 10-year CHD risk compared with UC among men and women with and without diabetes residing in the PA and non-PA region",
"Objective Despite antihypertensive treatment , most hypertensive patients still have high blood pressure ( BP ) , notably high systolic blood pressure ( SBP ) . The EFFICIENT study examines the efficacy and acceptability of a single-pill combination of sustained-release ( SR ) indapamide , a thiazide-like diuretic , and amlodipine , a calcium channel blocker ( CCB ) , in the management of hypertension . Methods Patients who were previously uncontrolled on CCB monotherapy ( BP≥140/90 mm Hg ) or were previously untreated with grade 2 or 3 essential hypertension ( BP≥160/100 mm Hg ) received a single-pill combination tablet containing indapamide SR 1.5 mg and amlodipine 5 mg daily for 45 days , in this multicenter prospect i ve phase 4 study . The primary outcome was mean change in BP from baseline ; percentage of patients achieving BP control ( BP mm Hg ) was a secondary endpoint . SBP reduction ( ΔSBP ) versus diastolic BP reduction ( ΔDBP ) was evaluated ( ΔSBP/ΔDBP ) from baseline to day 45 . Safety and tolerability were also assessed . Results Mean baseline BP of 196 patients ( mean age 52.3 years ) was 160.2/97.9 mm Hg . After 45 days , mean SBP decreased by 28.5 mm Hg ( 95 % CI , 26.4 to 30.6 ) , while diastolic BP decreased by 15.6 mm Hg ( 95 % CI , 14.5 to 16.7 ) . BP control ( patients . ΔSBP/ΔDBP was 1.82 in the overall population . Few patients ( n = 3 [ 2 % ] ) reported side effects , and most ( n = 194 [ 99 % ] ) adhered to treatment . Conclusion In patients who were previously uncontrolled on CCB monotherapy or untreated with grade 2 or 3 hypertension , single-pill combination indapamide SR/amlodipine reduced BP effectively — especially SBP— over 45 days , and was safe and well tolerated . Trial Registration Clinical Trial Registry – India",
"Introduction Māori are disproportionately affected by cardiovascular disease ( CVD ) , which is the main reason for the eight year difference in life expectancy between Māori and non-Māori . The primary care-based IMPACT ( IMProving Adherence using Combination Therapy ) trial evaluates whether fixed dose combination therapy ( a “ polypill ” ) improves adherence to guideline -based therapy compared with current care among people at high risk of CVD . Interventions shown in trials to be effective do not necessarily reduce ethnic disparities , and may in fact widen them . Indigenous population s with poorer health outcomes are often under-represented in trials so the effect of interventions can not be assessed for them , specifically . Therefore , the IMPACT trial aim ed to recruit as many Māori as non-Māori to assess the consistency of the effect of the polypill . This paper describes the methods and results of the recruitment strategy used to achieve this . Methods Experienced Māori research ers were involved in trial governance throughout trial development and conduct . The trial Steering Committee included leading Māori research ers and was committed to equal recruitment of Māori and non-Māori . Additional funding and Māori research nurses were sought to allow home-based assessment , establishment of the relationship between research nurse and participant , more family involvement prior to enrollment , continuity of the research nurse-participant relationship , and acknowledgement of other Māori culturally important procedures , interactions , language and manners . Primary care practice s with high enrollment of Māori were targeted , with over-sampling of potentially eligible Māori patients , lower thresholds for screening of Māori and 6 months continued Māori recruitment after non-Māori recruitment had finished . Results A total of 257 Māori and 256 non-Māori participants were r and omized . Four Māori and eight non-Māori participants were r and omized per research nurse per month . Potentially eligible Māori were more likely than non-Māori to proceed to subsequent stages of recruitment . Differences between r and omized Māori and non-Māori were evident ( e.g. Maori were less likely to have established coronary artery disease ) . Conclusions Recruitment of equal numbers of indigenous and non-indigenous participants is possible if it is prioritised , adequately re source d and self-determination is supported . Trial registration The trial is registered with the Australian New Zeal and Clinical Trial Registry",
"IMPORTANCE Most patients with cardiovascular disease ( CVD ) do not take recommended medications long-term . The use of fixed-dose combinations ( FDCs ) improves adherence in several clinical areas . Previous trials of cardiovascular FDCs have assessed short-term effects compared with placebo or no treatment . OBJECTIVE To assess whether FDC delivery of aspirin , statin , and 2 blood pressure-lowering agents vs usual care improves long-term adherence to indicated therapy and 2 major CVD risk factors , systolic blood pressure ( SBP ) and low-density lipoprotein cholesterol ( LDL-C ) . DESIGN , SETTING , AND PARTICIPANTS The UMPIRE trial , a r and omized , open-label , blinded-end-point trial among 2004 participants with established CVD or at risk of CVD enrolled July 2010-July 2011 in India and Europe . The trial follow-up concluded in July 2012 . INTERVENTIONS Participants were r and omly assigned ( 1:1 ) to an FDC-based strategy ( n=1002 ) containing either ( 1 ) 75 mg aspirin , 40 mg simvastatin , 10 mg lisinopril , and 50 mg atenolol or ( 2 ) 75 mg aspirin , 40 mg simvastatin , 10 mg lisinopril , and 12.5 mg hydrochlorothiazide or to usual care ( n=1002 ) . MAIN OUTCOMES AND MEASURES Adherence to medication ( defined as self-reported use of antiplatelet , statin , and ≥2 BP-lowering medications ) and changes in SBP and LDL-C from baseline . RESULTS At baseline , mean BP was 137/78 mm Hg , LDL-C was 91.5 mg/dL , and 1233 ( 61.5 % ) of 2004 participants reported use of antiplatelet , statin , and 2 or more BP-lowering medications . Median follow-up was 15 months ( interquartile range , 12 - 18 months ) . The FDC group had improved adherence vs usual care ( 86 % vs 65 % ; relative risk [ RR ] of being adherent , 1.33 ; 95 % CI , 1.26 - 1.41 ; P reductions in SBP ( -2.6 mm Hg ; 95 % CI , -4.0 to -1.1 mm Hg ; P .001 ) and LDL-C ( -4.2 mg/dL ; 95 % CI , -6.6 to -1.9 mg/dL ; P 727 participants ( 36 % ) , adherence at the end of study was 77 % vs 23 % ( RR , 3.35 ; 95 % CI , 2.74 - 4.09 ; P .001 for interaction ) , SBP was reduced by 4.9 mm Hg ( 95 % CI 7.3 - 2.6 mm Hg ; P = .01 for interaction ) , and LDL-C was reduced by 6.7 mg/dL ( 95 % CI , 10.5 - 2.8 mg/dL ; P = .11 for interaction ) . There were no significant differences in serious adverse events or cardiovascular events ( 50 [ 5 % ] in the FDC group and 35 [ 3.5 % ] in the usual care group ; RR , 1.45 ; 95 % CI , 0.94 - 2.24 ; P=.09 ) between the groups . CONCLUSIONS AND RELEVANCE Among patients with or at high risk of CVD , use of an FDC strategy for blood pressure , cholesterol , and platelet control vs usual care result ed in significantly improved medication adherence at 15 months and statistically significant but small improvements in SBP and LDL-C. TRIAL REGISTRATION clinical trials.gov Identifier : NCT01057537",
"BACKGROUND The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome . No study , however , has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease ( CHD ) in hypertensive patients who are not conventionally deemed dyslipidaemic . METHODS Of 19342 hypertensive patients ( aged 40 - 79 years with at least three other cardiovascular risk factors ) r and omised to one of two antihypertensive regimens in the Anglo-Sc and inavian Cardiac Outcomes Trial , 10305 with non-fasting total cholesterol concentrations 6.5 mmol/L or less were r and omly assigned additional atorvastatin 10 mg or placebo . These patients formed the lipid-lowering arm of the study . We planned follow-up for an average of 5 years , the primary endpoint being non-fatal myocardial infa rct ion and fatal CHD . Data were analysed by intention to treat . FINDINGS Treatment was stopped after a median follow-up of 3.3 years . By that time , 100 primary events had occurred in the atorvastatin group compared with 154 events in the placebo group ( hazard ratio 0.64 [ 95 % CI 0.50 - 0.83 ] , p=0.0005 ) . This benefit emerged in the first year of follow-up . There was no significant heterogeneity among prespecified subgroups . Fatal and non-fatal stroke ( 89 atorvastatin vs 121 placebo , 0.73 [ 0.56 - 0.96 ] , p=0.024 ) , total cardiovascular events ( 389 vs 486 , 0.79 [ 0.69 - 0.90 ] , p=0.0005 ) , and total coronary events ( 178 vs 247 , 0.71 [ 0.59 - 0.86 ] , p=0.0005 ) were also significantly lowered . There were 185 deaths in the atorvastatin group and 212 in the placebo group ( 0.87 [ 0.71 - 1.06 ] , p=0.16 ) . Atorvastatin lowered total serum cholesterol by about 1.3 mmol/L compared with placebo at 12 months , and by 1.1 mmol/L after 3 years of follow-up . INTERPRETATION The reductions in major cardiovascular events with atorvastatin are large , given the short follow-up time . These findings may have implication s for future lipid-lowering guidelines",
"A line of epidemiological studies suggests that the accumulation of coronary risk factors promotes the progression of coronary atherosclerosis . Recent clinical studies showed that aggressive low-density lipoprotein ( LDL ) cholesterol-lowering therapy using statins could regress coronary atheroma and reduce major cardiovascular events . Additionally , therapy that controlled amlodipine-based blood pressure reduced major cardiovascular events in patients with hypertension compared with an atenolol-based regimen . An open-label r and omized multicenter study is primarily planned to evaluate the changes in coronary atheroma volume using intravascular ultrasonography 18–24 months after intensive lowering of LDL-cholesterol and blood pressure compared with a st and ard therapy indicated by current guidelines in Japanese patients with coronary artery disease ( CAD ) . The secondary endpoints include changes in serum lipid levels , inflammatory markers , glucose markers and blood pressure . In total , 100 subjects with CAD who are undergoing percutaneous coronary intervention will be tested . The MILLION study will provide new evidence and therapeutic st and ards for the prevention of CAD in Japanese patients by controlling both LDL-C levels and blood pressure",
"In spite of advances in prevention and treatment , the burden of cardiovascular diseases is increasing . A fixed-dose combination ( FDC ) pill , or \" polypill , \" composed of evidence -based drugs has been proposed as a means of improving cardiovascular prevention by reducing cost and increasing patient adherence to treatment . The aim of the FOCUS project , funded by the 7th Framework Programme of the European Commission , is to characterize the factors that underlie inadequate secondary prevention and to test a new FDC . To achieve these goals , a 9-member consortium has been constituted , including institutions from Argentina , France , Italy , Spain , and Switzerl and . FOCUS Phase-1 will examine factors potentially related to lack of adequate secondary prevention in 4,000 post-myocardial infa rct ion ( MI ) patients and analyze the relationship between these factors and patient treatment adherence . Primary end points will be ( 1 ) the percentage of patients receiving aspirin , angiotensin-converting enzyme inhibitors , and statins and ( 2 ) adherence to treatment measured by the Morisky-Green test . FOCUS Phase-2 is a r and omized trial that will compare adherence to treatment in 1,340 post-myocardial infa rct ion patients either receiving an FDC comprising aspirin ( 100 mg ) , ramipril ( 2.5 , 5 , or 10 mg ) , and simvastatin ( 40 mg ) or receiving the same 3 drugs separately ",
"Background The feasibility of conducting a large-scale Polypill clinical trial in developing countries remains unclear . More information is needed regarding the efficacy in reducing the risk factors of cardiovascular disease ( CVD ) , side effects , improvement in adherence and physician/patient \" acceptability \" of the Polypill . Methods We conducted an open-label , parallel-group , r and omized clinical trial involving three sites in Sri Lanka that enrolled a total of 216 patients without established CVD . The trial compared a Polypill ( 75 mg aspirin , 20 mg simvastatin , 10 mg lisinopril and 12.5 mg hydrochlorothiazide ) to St and ard Practice . After r and omization , patients were followed monthly for three months . Pre-specified primary outcomes included reduction in systolic blood pressure , total cholesterol and estimated 10-year CVD risk . We also evaluated the recruitment process and acceptability of the Polypill by both physicians and patients . Results Patients were recruited in a six-month period as planned . Two hundred three patients ( 94.0 % ) completed the treatment program and returned for their three-month follow-up visits . No safety concerns were reported . These findings suggest a high rate of patient acceptability , a finding that is bolstered by the majority of patients completing the trial ( 90 % ) indicating that they would take the Polypill \" for life \" if proven to be effective in reducing CVD risk . Approximately 86 % of the physicians surveyed agreed with and supported use of the Polypill for primary prevention and 93 % for secondary prevention of CVD . Both the Polypill and St and ard Practice result ed in marked reductions in systolic blood pressure , total cholesterol and 10-year risk of CVD . However , the differences between the treatment groups were not statistically significant . Conclusions We successfully completed a Polypill feasibility trial in Sri Lanka . We were able to document high acceptability of the Polypill to patients and physicians . We were unable to estimate the risk factor reductions on the Polypill because the control group received similar treatment with individual drugs . The Polypill was however simpler and achieved comparable risk factor reductions , highlighting its potential usefulness in the prevention of CVD.Trial registration number Clinical trials.gov :",
"Introduction The efficacy and safety of single-pill amlodipine/atorvastatin for reducing blood pressure ( BP ) , low-density lipoprotein cholesterol ( LDLC ) , and predicted 10-year cardiovascular ( CV ) risk have been demonstrated in low CV risk countries . The Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET ® ( amlodipine besylate/atorvastatin calcium ; Pfizer , Morrisville , PA , USA ; STRONG DUET ) study evaluated its clinical utility in Slovakia , one of the highest CV risk regions in Europe . Methods This was a two-phase study involving 100 outpatient cardiologist and internist departments in Slovakia . Phase 1 assessed BP control and CV risk profiles in adults with treated hypertension , and phase 2 was an open-label , multicenter , observational study . In the phase 2 study , patients with treated but uncontrolled hypertension and three or more coronary heart disease risk factors received single-pill amlodipine/atorvastatin ( 5/10 or 10/10 mg ) for 12 weeks . Major outcomes were the percentage of patients achieving target BP ( ≤140/90 mmHg ) and /or LDL-C ( ≤3 mmol/L ) and reductions in predicted 10-year CV risk . Results Of the 4,672 phase 1 patients , 80.8 % had uncontrolled hypertension and 61.4 % had dyslipidemia . Of the 1,406 phase 2 patients , 90.3 % of patients achieved target BP at week 12 , 66.3 % achieved target LDL-C , and 60.7 % achieved both . The mean 10-year CV risk was reduced by 49 % ( P amlodipine/atorvastatin was associated with significant improvements in BP , LDL-C target attainment , and 10-year CV risk in patients with uncontrolled hypertension in Slovakia . The treatment was well-tolerated and safe . Use of single-pill amlodipine/atorvastatin in high CV-risk countries could lead to significant improvements in CV risk management",
"OBJECTIVE As hypertension and dyslipidemia are frequent comorbidities , antihypertensive drugs and lipid-lowering agents are often prescribed together for their treatment . Telmisartan and rosuvastatin are widely used together to treat hypertension and dyslipidemia . A combination formulation of these two drugs would improve patient compliance due to ease of dosing . The purpose of this study was to assess bioequivalence of single-dose administration of a newly-developed fixed-dose combination ( FDC ) tablet containing telmisartan/rosuvastatin 80/20 mg ( test treatment ) and coadministration of a telmisartan 80-mg tablet and a rosuvastatin 20-mg tablet ( reference treatment ) in healthy Korean male volunteers . METHODS This was a single-dose , r and omized , open-label , 2-period crossover study enrolling healthy males aged 20 - 50 years with BMI between 18.5 and 25 kg/m2 . Each subject received a single dose of the reference and test treatments with a 14-day washout period . Blood sampling was performed at prespecified intervals for up to 72 hours after dosing . Primary pharmacokinetic parameters were Cmax , AUClast , and AUC0-∞ of telmisartan , rosuvastatin , and N-desmethyl rosuvastatin . Bioequivalence was assessed by determining whether the 90 % confidence intervals ( CIs ) of the geometric mean ratios ( test treatment/reference treatment ) of these parameters were within the st and ard range of 80 % to 125 % . Adverse events were monitored via regular interviews with the subjects and by physical examinations . RESULTS 60 subjects were enrolled and 55 completed the study . The 90 % CIs of the geometric mean ratios of Cmax , AUClast , and AUC00-∞ were 0.9262 - 1.1498 , 0.9294 - 1.0313 , and 0.9312 - 1.0320 for telmisartan , 0.9041 - 1.0428 , 0.9262 - 1.0085 , and 0.9307 - 1.0094 for rosuvastatin , and 0.8718 - 1.0022 , 0.8901 - 0.9904 , and 0.8872 - 0.9767 for N-desmethyl rosuvastatin , respectively . There was no statistical difference in the incidence of adverse events ( AEs ) ( all of which were mild or moderate ) between the reference and test treatments . CONCLUSIONS Our findings suggest that the telmisartan/rosuvastatin FDC is bioequivalent to coadministration of separate tablets , and both treatments were safe and well tolerated . Administration of this FDC tablet is expected to improve patient compliance",
"Introduction In most treated patients with hypertension , a two or more drug combination is required to achieve adequate blood pressure ( BP ) control . In our study we assessed whether the combination of zofenopril + hydrochlorothiazide ( HCTZ ) was at least as effective as irbesartan + HCTZ in essential hypertensives with at least one additional cardiovascular risk factor , uncontrolled by a previous monotherapy . Methods After a 2-week placebo washout , 361 treated hypertensive patients [ office sitting diastolic BP ( DBP ) , ≥90 mmHg ] , aged 18–75 years , were r and omized double blind to 18-week treatment with zofenopril 30 mg plus HCTZ 12.5 mg or irbesartan 150 mg plus HCTZ 12.5 mg once daily , in an international , multicenter study . After the first 6 and 12 weeks , zofenopril and irbesartan doses could be doubled in non-normalized subjects . The primary study end point was the office sitting DBP reduction after 18 weeks of treatment . Secondary end points included office systolic BP ( SBP ) , ambulatory BP and high sensitivity C-reactive protein ( hs-CRP ) . Results The between-treatment difference for office DBP averaged to + 1.0 ( 95 % CI −0.4 , + 0.8 ) mmHg ( P = 0.150 ) , the upper limit of the 95 % confidence interval being inferior to the protocol -defined non-inferiority limit ( 3 mmHg ) . In the subset of patients with valid ambulatory BP , no difference in 24-h average DBP [ n = 181 ; 6.7 ( 8.7 , 4.6 ) zofenopril + HCTZ vs. 6.3 ( 8.8 , 3.7 ) mmHg irbesartan + HCTZ , P = 0.810 ] and SBP reductions [ 11.7 ( 15.4 , 8.0 ) vs. 12.6 ( 17.2 , 8.0 ) mmHg , P = 0.758 ] were observed between the two treatment groups . hs-CRP was reduced by zofenopril + HCTZ [ −0.52 ( −1.05 , 0.01 ) mg/L ] , while it was increased by irbesartan plus HCTZ [ 0.97 ( 0.29 , 1.65 ) mg/L , P = 0.001 between treatments ] . Conclusion In previously monotherapy-treated , uncontrolled patients with hypertension , zofenopril 30–60 mg + HCTZ 12.5 mg is as effective as irbesartan 150–300 mg plus HCTZ 12.5 mg , with the added value of a potential protective effect against vascular inflammation ",
"Background A Polypill is proposed for the primary prevention of cardiovascular disease in people judged to be at risk on account of their age alone . Its efficacy in reducing cholesterol and blood pressure is uncertain . Methods We conducted a r and omized double-blind placebo-controlled crossover trial of a Polypill among individuals aged 50 + without a history of cardiovascular disease and compared the reductions with those predicted from published estimates of the effects of the individual drugs . Participants took the Polypill ( amlodipine 2.5 mg , losartan 25 mg , hydrochlorothiazide 12.5 mg and simvastatin 40 mg ) each evening for 12 weeks and a placebo each evening for 12 weeks in r and om sequence . The mean within-person differences in blood pressure and low density lipoprotein ( LDL ) cholesterol at the end of each 12 week period were determined . Results 84 out of 86 participants completed both treatment periods . The mean systolic blood pressure was reduced by 17.9 mmHg ( 95 % CI , 15.7–20.1 ) on the Polypill , diastolic blood pressure by 9.8 mmHg ( 8.1–11.5 ) , and LDL cholesterol by 1.4 mmol/L ( 1.2–1.6 ) , reductions of 12 % , 11 % , and 39 % respectively . The results were almost identical to those predicted ; 18.4 mmHg , 9.7 mmHg , and 1.4 mmol/L respectively . Conclusion The Polypill result ed in the predicted reductions in blood pressure and LDL cholesterol . Long term reductions of this magnitude would have a substantial effect in preventing heart attacks and strokes . Trial Registration Controlled-Trials.com IS RCT",
"Introduction This paper describes a planned process evaluation of the Use of a Multidrug Pill In Reducing Cardiovascular Events ( UMPIRE ) trial , one of several r and omised clinical trials taking place globally to assess the potential of cardiovascular drugs as a fixed-dose combination ( polypill ) in cardiovascular disease prevention . A fixed-dose combination may be a promising strategy for promoting adherence to medication ; alleviating pill burden through simplifying regimens and reducing cost . This process evaluation will complement the UMPIRE trial by using qualitative research methods to inform underst and ing of the complex interplay of factors that underpin trial outcomes . Methods A series of semistructured , in-depth interviews with local health professionals and UMPIRE trial participants in India and the UK will be undertaken . The aim is to underst and their views and experiences of the trial context and of day-to-day use of medications more generally . The grounded theory approach will be used to analyse data and help inform the processes of the UMPIRE trial . Ethics and dissemination The study has received ethical approval for all sites in the UK and India where trial participant interviews will be undertaken . The process evaluation will help inform and enhance the underst and ing of the UMPIRE trial results and its applicability to clinical practice as well as shaping policy regarding strategies for improving cardiovascular medication adherence",
"Background Cardiovascular diseases ( CVD ) are responsible for significant morbidity , premature mortality , and economic burden . Despite established evidence that supports the use of preventive medications among patients at high CVD risk , treatment gaps remain . Building on prior evidence and a theoretical framework , a complex intervention has been design ed to address these gaps among high-risk , under-treated patients in the Australian primary care setting . This intervention comprises a general practice quality improvement tool incorporating clinical decision support and audit/feedback capabilities ; availability of a range of CVD polypills ( fixed-dose combinations of two blood pressure lowering agents , a statin ± aspirin ) for prescription when appropriate ; and access to a pharmacy-based program to support long-term medication adherence and lifestyle modification . Methods Following a systematic development process , the intervention will be evaluated in a pragmatic cluster r and omized controlled trial including 70 general practice s for a median period of 18 months . The 35 general practice s in the intervention group will work with a nominated partner pharmacy , whereas those in the control group will provide usual care without access to the intervention tools . The primary outcome is the proportion of patients at high CVD risk who were inadequately treated at baseline who achieve target blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) levels at the study end . The outcomes will be analyzed using data from electronic medical records , utilizing a vali date d extraction tool . Detailed process and economic evaluations will also be performed . Discussion The study intends to establish evidence about an intervention that combines technological innovation with team collaboration between patients , pharmacists , and general practitioners ( GPs ) for CVD prevention . Trial registration Australian New Zeal and Clinical Trials Registry",
"Objective To compare the effects of two antihypertensive treatment strategies for the prevention of coronary heart disease and other cardiovascular events in the large sub population ( n = 5137 ) with diabetes mellitus in the blood pressure-lowering arm of the Anglo-Sc and inavian Cardiac Outcomes Trial . Methods Patients had either untreated hypertension or treated hypertension . For those with type II diabetes mellitus , inclusion criteria required at least two additional risk factors . Patients were r and omized to amlodipine with addition of perindopril as required ( amlodipine-based ) or atenolol with addition of thiazide as required ( atenolol-based ) . Therapy was titrated to achieve a target blood pressure of less than 130/80 mmHg . Results The trial was terminated early due to significant benefits on mortality and stroke associated with the amlodipine-based regimen . In patients with diabetes mellitus , the amlodipine-based treatment reduced the incidence of the composite endpoint – total cardiovascular events and procedures – compared with the atenolol-based regimen ( hazard ratio 0.86 , confidence interval 0.76–0.98 , P = 0.026 ) . Fatal and nonfatal strokes were reduced by 25 % ( P = 0.017 ) , peripheral arterial disease by 48 % ( P = 0.004 ) and noncoronary revascularization procedures by 57 % ( P coronary heart disease deaths and nonfatal myocardial infa rct ions ( the primary endpoint ) , which were reduced nonsignificantly by 8 % ( hazard ratio 0.92 , confidence interval 0.74–1.15 ) . Conclusion In the large diabetic subgroup in the blood pressure-lowering arm of the Anglo-Sc and inavian Cardiac Outcomes Trial , the benefits of amlodipine-based treatment , compared with atenolol-based treatment , on the incidence of total cardiovascular events and procedures was significant ( 14 % reduction ) and similar to that observed in the total trial population ( 16 % reduction )",
"Background Cardiovascular disease ( CVD ) is a major cause of death in China . Despite government efforts , the majority of hypertensive and diabetic patients in China do not receive proper treatment . Reducing CVD events requires long-term care that is proactive , patient-centred , community-based , and sustainable . We have design ed a package of interventions for patients at high risk of CVD to be implemented by family doctors based in township hospitals ( providers of primary care ) in rural Zhejiang , China . This trial aims to determine whether the systematic CVD risk reduction package results in reduced CVD events among patients at risk of CVD compared with usual care , and whether the package is cost-effective and suitable for routine implementation and scale-up . Methods / Design This is a prospect i ve , open-label , cluster r and omized controlled trial ( RCT ) with blinded data analysis . The trial will r and omize 67 township hospitals with 31,708 participants in three counties in Zhejiang Province . Participants will be identified from existing health records and will comprise adults aged 50 to 74 years , with a calculated 10-year CVD risk of 20 % or higher , or diabetes . In the intervention arm , participants will receive a package of interventions including : 1 ) healthy lifestyle counseling ( smoking cessation , and salt , oil , and alcohol reduction ) ; 2 ) prescription of a combination of drugs ( antihypertensives , aspirin , and statin ) ; and 3 ) adherence support for drug compliance and healthy lifestyle change . In the control arm , participants will receive usual care for hypertension and diabetes management at individual clinicians ’ discretion . The primary outcome is the incidence of severe CVD events over 24 months of follow-up . All CVD events will be defined according to the World Health Organization ( WHO ) monitoring of trends and determinants in cardiovascular disease ( MONICA ) definitions , diagnosed at the county hospital or higher level , and reported by the Zhejiang surveillance system . Secondary outcomes include : mean systolic and diastolic blood pressure , blood glucose , serum total cholesterol ( TC ) , and adherence to appointments , and drugs and lifestyle changes . Discussion This trial focuses on risk reduction of CVD rather than specific diseases . It is not design ed to compare therapeutic and healthy lifestyle interventions , but rather their combined effects in primary care setting s. Through the trial , we intend to underst and the effectiveness of the comprehensive CVD reduction package in routine practice . We also intend to underst and the barriers and facilitators to implementing the package , and thus to advise on policy and practice change . Trial registration Current Controlled Trials : IS RCT",
"Background Patients with hypertension and cardiovascular disease ( CVD ) , diabetes , or chronic kidney disease ( CKD ) usually require two or more antihypertensive agents to achieve blood pressure ( BP ) goals . Methods The efficacy/safety of olmesartan ( OM ) 40 mg , amlodipine besylate ( AML ) 10 mg , and hydrochlorothiazide ( HCTZ ) 25 mg versus the component dual-combinations ( OM 40/AML 10 mg , OM 40/HCTZ 25 mg , and AML 10/HCTZ 25 mg ) was evaluated in participants with diabetes , CKD , or chronic CVD in the Triple Therapy with Olmesartan Medoxomil , Amlodipine , and Hydrochlorothiazide in Hypertensive Patients Study ( TRINITY ) . The primary efficacy end point was least squares ( LS ) mean reduction from baseline in seated diastolic BP ( SeDBP ) at week 12 . Secondary end points included LS mean reduction in SeSBP and proportion of participants achieving BP goal ( LS mean reduction in SeBP and BP goal achievement at week 52/early termination ( open-label period ) . Results At week 12 , OM 40/AML 10/HCTZ 25 mg result ed in significantly greater SeBP reductions in participants with diabetes ( −37.9/22.0 mm Hg vs −28.0/17.6 mm Hg for OM 40/AML 10 mg , −26.4/14.7 mm Hg for OM 40/HCTZ 25 mg , and −27.6/14.8 mm Hg for AML 10/HCTZ 25 mg ) , CKD ( −44.3/25.5 mm Hg vs −39.5/23.8 mm Hg for OM 40/AML 10 mg , −25.3/17.0 mm Hg for OM 40/HCTZ 25 mg , and −33.4/20.6 mm Hg for AML 10/HCTZ 25 mg ) , and chronic CVD ( −37.8/20.6 mm Hg vs −31.7/18.2 mm Hg for OM 40/AML 10 mg , −30.9/17.1 mm Hg for OM 40/HCTZ 25 mg , and −27.5/16.1 mm Hg for AML 10/HCTZ 25 mg ) ( P ) . BP goal achievement was greater for participants receiving triple-combination treatment compared with the dual-combination treatments , and was achieved in 41.1 % , 55.0 % , and 38.9 % of participants with diabetes , CKD , and chronic CVD on OM 40/AML 10/HCTZ 25 mg , respectively . At week 52 , there was sustained BP lowering with the OM/AML/HCTZ regimen . Overall , the triple combination was well tolerated . Conclusions In patients with diabetes , CKD , or chronic CVD , short-term ( 12 weeks ) and long-term treatment with OM 40/AML 10/HCTZ 25 mg was well tolerated , lowered BP more effectively , and enabled more participants to reach BP goal than the corresponding 2-component regimens . Trial Identification",
"Background The grading of recommendation , assessment , development and evaluation ( GRADE ) approach is widely implemented in health technology assessment and guideline development organisations throughout the world . GRADE provides a transparent approach to reaching judgements about the quality of evidence on the effects of a health care intervention , but is complex and therefore challenging to apply in a consistent manner . Methods We developed a checklist to guide the research er to extract the data required to make a GRADE assessment . We applied the checklist to 29 meta-analyses of r and omised controlled trials on the effectiveness of health care interventions . Two review ers used the checklist for each paper and used these data to rate the quality of evidence for a particular outcome . Results For most ( 70 % ) checklist items , there was good agreement between review ers . The main problems were for items relating to indirectness where considerable judgement is required . Conclusions There was consistent agreement between review ers on most items in the checklist . The use of this checklist may be an aid to improving the consistency and reproducibility of GRADE assessment s , particularly for inexperienced users or in rapid review s without the re sources to conduct assessment s by two research ers independently",
"AIMS Recent trials of cardiovascular polypills in high-risk population s show improvements in the use of cardiovascular preventive treatments , compared to usual care . We describe patterns of pill burden in Australian practice , define the impact of polypill therapy on pill burden , and explore how physicians add medication to polypill therapy . METHODS The Kanyini Guidelines Adherence with the Polypill Study was an open-label trial involving 623 participants in Australia which r and omized participants to a polypill strategy ( containing a statin , antiplatelet agent , and two blood-pressure-lowering medications ) or usual care . Participants either had established cardiovascular disease or were at high calculated risk ( ≥15 % over 5 years ) . Current medications , daily pill burden , and self-reported use of combination treatment were recorded prior to r and omization and at study end . Median pill burden at baseline and study end was compared in both arms . Subgroup analysis of the polypill strategy on trial primary outcomes was conducted by pill burden at baseline . RESULTS Median total and cardiovascular pill burdens of the polypill group decreased from 7 to 5 and from 4 to 2 , respectively ( median change -2 ; IQR -3 , 0 ) , with no change in the usual care group ( comparison of change ; P for noncardiovascular medications . Of those still using the polypill at study end , 43.8 % were prescribed additional medications ; 84.5 % of these additional medications were blood-pressure-lowering medications . Within the polypill group , lower pill burden at baseline was associated with greater increases in the use of indicated cardiovascular preventive medications at study end compared to those with higher pill burdens . No trend was observed between the level of baseline pill burden and the effect of poylpill treatment on systolic blood pressure or total cholesterol . CONCLUSION A cardiovascular polypill in contemporary Australian practice reduces cardiovascular and total pill burdens , despite frequent prescription of additional medications",
"Patients presenting with UTI symptoms are among the most frequent clinical presentations in primary care accounting for 15 % of all community antibiotic prescriptions . The diagnostic accuracy of clinical assessment and the most appropriate management of uncomplicated UTI remain unclear . Primary care clinicians are more likely to treat empirically without additional testing . Some advances are being made in the development of novel Point of Care Tests ( POCTs ) for diagnosis of infection and antibiotic resistance in primary care . The incorporation of a test , which enumerates and identifies pathogens and their antibiotic resistance , into a management strategy for UTI has great potential for improving patient outcomes reducing antibiotic use and in turn in reducing the incidence of antimicrobial resistance . While some new promising POCT technologies are being developed , these have not been fully evaluated in primary care . Robust evaluation , providing solid evidence supporting POCT use , which is based on patient benefit , cost-effectiveness , therapeutic choice , microbiological outcomes , and uptake and acceptance into primary care is required . We have design ed a ‘ process-pathway ' model which incorporates acceptability parameters for a POCT in primary care , and incorporates four distinct stages : Stage 1 . Piloting of a novel POCT for diagnosis of UTI in primary care . Stage 2 . An observational stage to describe current primary care management of uncomplicated UTI and incidence of uropathogens Stage 3 . A r and omised controlled trial rigorously evaluating the POCT as part of a rapid diagnostic and treatment regime for uncomplicated UTI . Stage 4 . Evaluating the uptake of the POCT in general practice",
"Aims Recent data indicate that fixed-dose combination ( FDC ) pills , polypills , can produce sizeable risk factor reductions . There are very few published data on the consistency of the effects of a polypill in different patient population s. It is unclear for example whether the effects of the polypill are mainly driven by the individuals with high individual risk factor levels . The aim of the present study is to examine whether baseline risk factor levels modify the effect of polypill treatment on low-density lipoprotein (LDL)-cholesterol , blood pressure ( BP ) , calculated cardiovascular relative risk reduction and adverse events . Methods This paper describes a post-hoc analysis of a r and omised , placebo-controlled trial of a polypill ( containing aspirin 75 mg , simvastatin 20 mg , lisinopril 10 mg and hydrochlorothiazide 12.5 mg ) in 378 individuals without an indication for any component of the polypill , but who had an estimated five-year risk for cardiovascular disease ≥7.5 % . The outcomes considered were effect modification by baseline risk factor levels on change in LDL-cholesterol , systolic BP , calculated cardiovascular relative risk reduction and adverse events . Results The mean LDL-cholesterol in the polypill group was 0.9 mmol/l ( 95 % confidence interval ( CI ) : 0.8–1.0 ) lower compared with the placebo group during follow-up . Those with a baseline LDL-cholesterol > 3.6 mmol/l achieved a greater absolute LDL-cholesterol reduction with the polypill compared with placebo , than patients with an LDL-cholesterol ≤3.6 mmol/l ( −1.1 versus −0.6 mmol/l , respectively ) . The mean systolic BP was 10 mm Hg ( 95 % CI : 8–12 ) lower in the polypill group . In participants with a baseline systolic BP > 135 mm Hg the polypill result ed in a greater absolute systolic BP reduction with the polypill compared with placebo , than participants with a systolic BP ≤ 135 mm Hg ( −12 versus −7 mm Hg , respectively ) . Calculated from individual risk factor reductions , the mean cardiovascular relative risk reduction was 48 % ( 95 % CI : 43–52 ) in the polypill group . Both baseline LDL-cholesterol and estimated cardiovascular risk were significant modifiers of the estimated cardiovascular relative risk reduction caused by the polypill . Adverse events did not appear to be related to baseline risk factor levels or the estimated cardiovascular risk . Conclusion This study demonstrated that the effect of a cardiovascular polypill on risk factor levels is modified by the level of these risk factors . Groups defined by baseline LDL-cholesterol or systolic BP had large differences in risk factor reductions but only moderate differences in estimated cardiovascular relative risk reduction , suggesting also that patients with mildly increased risk factor levels but an overall raised cardiovascular risk benefit from being treated with a polypill",
"BACKGROUND Although most cardiovascular disease occurs in low-income and middle-income countries , little is known about the use of effective secondary prevention medications in these communities . We aim ed to assess use of proven effective secondary preventive drugs ( antiplatelet drugs , β blockers , angiotensin-converting-enzyme [ ACE ] inhibitors or angiotensin-receptor blockers [ ARBs ] , and statins ) in individuals with a history of coronary heart disease or stroke . METHODS In the Prospect i ve Urban Rural Epidemiological ( PURE ) study , we recruited individuals aged 35 - 70 years from rural and urban communities in countries at various stages of economic development . We assessed rates of previous cardiovascular disease ( coronary heart disease or stroke ) and use of proven effective secondary preventive drugs and blood-pressure-lowering drugs with st and ardised question naires , which were completed by telephone interviews , household visits , or on patient 's presentation to clinics . We report estimates of drug use at national , community , and individual levels . FINDINGS We enrolled 153,996 adults from 628 urban and rural communities in countries with incomes classified as high ( three countries ) , upper-middle ( seven ) , lower-middle ( three ) , or low ( four ) between January , 2003 , and December , 2009 . 5650 participants had a self-reported coronary heart disease event ( median 5·0 years previously [ IQR 2·0 - 10·0 ] ) and 2292 had stroke ( 4·0 years previously [ 2·0 - 8·0 ] ) . Overall , few individuals with cardiovascular disease took antiplatelet drugs ( 25·3 % ) , β blockers ( 17·4 % ) , ACE inhibitors or ARBs ( 19·5 % ) , or statins ( 14·6 % ) . Use was highest in high-income countries ( antiplatelet drugs 62·0 % , β blockers 40·0 % , ACE inhibitors or ARBs 49·8 % , and statins 66·5 % ) , lowest in low-income countries ( 8·8 % , 9·7 % , 5·2 % , and 3·3 % , respectively ) , and decreased in line with reduction of country economic status ( p(trend) received no drugs in high-income countries ( 11·2 % ) , compared with 45·1 % in upper middle-income countries , 69·3 % in lower middle-income countries , and 80·2 % in low-income countries . Drug use was higher in urban than rural areas ( antiplatelet drugs 28·7 % urban vs 21·3 % rural , β blockers 23·5%vs 15·6 % , ACE inhibitors or ARBs 22·8%vs 15·5 % , and statins 19·9%vs 11·6 % ; all p affected rates of drug use more than did individual-level factors ( eg , age , sex , education , smoking status , body-mass index , and hypertension and diabetes statuses ) . INTERPRETATION Because use of secondary prevention medications is low worldwide-especially in low-income countries and rural areas - systematic approaches are needed to improve the long-term use of basic , inexpensive , and effective drugs . FUNDING Full funding sources listed at end of paper ( see Acknowledgments )",
"Background Most individuals at high cardiovascular disease ( CVD ) risk worldwide do not receive any or optimal preventive drugs . We aim ed to determine whether fixed dose combinations of generic drugs ( ‘ polypills ’ ) would promote use of such medications . Methods We conducted a r and omized , open-label trial involving 623 participants from Australian general practice s. Participants had established CVD or an estimated five-year CVD risk of ≥15 % , with indications for antiplatelet , statin and ≥2 blood pressure lowering drugs ( ‘ combination treatment ’ ) . Participants r and omized to the ‘ polypill-based strategy ’ received a polypill containing aspirin 75 mg , simvastatin 40 mg , lisinopril 10 mg and either atenolol 50 mg or hydrochlorothiazide 12.5 mg . Participants r and omized to ‘ usual care ’ continued with separate medications and doses as prescribed by their doctor . Primary outcomes were self-reported combination treatment use , systolic blood pressure and total cholesterol . Results After a median of 18 months , the polypill-based strategy was associated with greater use of combination treatment ( 70 % vs. 47 % ; relative risk 1.49 , ( 95 % confidence interval ( CI ) 1.30 to 1.72 ) p without differences in systolic blood pressure ( −1.5 mmHg ( 95 % CI −4.0 to 1.0 ) p = 0.24 ) or total cholesterol ( 0.08 mmol/l ( 95 % CI −0.06 to 0.22 ) p = 0.26 ) . At study end , 17 % and 67 % of participants in polypill and usual care groups , respectively , were taking atorvastatin or rosuvastatin . Conclusion Provision of a polypill improved self-reported use of indicated preventive treatments . The lack of differences in blood pressure and cholesterol may reflect limited study power , although for cholesterol , improved statin use in the polypill group counter-balanced use of more potent statins with usual care",
"Poor control of hypertension or dyslipidemia may at least in part be due to these risk factors being treated in isolation . The Caduet in Untreated Subjects Population ( CUSP ) trial was an 8-week , r and omized , double-blind , placebo-controlled trial evaluating the efficacy/safety of the combination of a calcium channel blocker ( amlodipine besylate ) and a statin ( atorvastatin calcium ) in a single-pill form ( 5/20 mg ) plus therapeutic lifestyle changes ( TLC ) compared with placebo plus TLC in patients with comorbid hypertension and dyslipidemia without evidence of cardiovascular disease . At week 4 , additional antihypertensive/lipid-lowering medication was permitted . The primary end point was the proportion of patients in whom the dual goal of blood pressure ( low-density lipoprotein cholesterol control ( dual goal attainment was significantly greater with amlodipine/atorvastatin plus TLC compared with placebo plus TLC at week 4 ( 47.6 % vs 1.7 % ; P adverse events were mild to moderate . Therapy with single-pill amlodipine/atorvastatin plus TLC in these patients significantly increased dual blood pressure/low-density lipoprotein cholesterol goal attainment compared with placebo plus TLC",
"BACKGROUND Frail and polypathological patients ( PP ) are often undertreated with evidence -based cardiovascular drugs , as their benefits are uncertain in this population . OBJECTIVES To determine the effects of treatment with renin-angiotensin system blockers/inhibitors ( ACEI/ARB ) , statins and /or beta-blockers on survival rates and functional decline in PP with evidence -based clinical indications for treatment with any of these drug families . METHOD Prospect i ve observational multicentre cohort study with a 12-month follow-up period . We selected PP with any condition of the following : chronic heart failure , coronary heart disease , chronic renal disease , cerebrovascular disease , peripheral artery disease , diabetes mellitus with any visceral involvement , hypertension , and dyslipidaemia . Clinical , functional ( Barthel index ) , socio-familial risk data and drug prescriptions were measured at baseline . Multivariate Cox proportional hazards and logistic regression models were used to identify variables independently associated with survival and functional decline . RESULTS The analysis included 1260 PP . The mean age was 79±9.5 years . The mortality rate was 34.5 % . Statin ( aHR 0.671 ; P=0.001 ) , beta-blocker plus statin ( aHR 0.645 ; P=0.007 ) , ACEI/ARB plus statin ( aHR 0.680 ; P=0.002 ) , or combined ACEI/ARB plus statin plus beta-blocker ( aHR 0.541 ; P=0.000 ) prescriptions were associated with longer survival times . Additionally , PP whose Barthel index was ≥60 showed a lower risk of disability progression if treated with statins ( aOR=0.476 ; P=0.000 ) , or their combinations , mainly with ACEI/ARB plus beta-blockers ( aOR 0.563 ; P=0.031 ) . CONCLUSIONS The prescription of statins , alone or in combination with other drugs , may impact the survival and functional decline in polypathological patients . Further prospect i ve blinded r and omised assays are needed to confirm these observations",
"AIM Our objective was to investigate the effects and tolerability of fixed-dose combination therapy on blood pressure and LDL in adults without elevated blood pressure or lipid levels . METHODS This was a double-blind r and omised placebo-controlled trial in residents of Kalaleh , Golestan , Iran . Following an 8-week placebo run-in period , 475 participants , aged 50 to 79 years , without cardiovascular disease , hypertension or hyperlipidaemia were r and omised to fixed-dose combination therapy with aspirin 81 mg , enalapril 2.5 mg , atorvastatin 20 mg and hydrochlorothiazide 12.5 mg ( polypill ) or placebo for a period of 12 months . The primary outcomes were changes in LDL-cholesterol , systolic and diastolic blood pressure and adverse reactions . Analysis was by intention-to-treat basis . RESULTS At baseline , there were differences in systolic blood pressure ( 6 mmHg ) . Taking account of baseline differences , at 12 months , polypill was associated with statistically significant reductions in blood pressure ( 4.5/1.6 mmHg ) and LDL-cholesterol ( 0.46 mmol/l ) . The study drug was well tolerated , but result ed in the modest reductions in blood pressure and lipid levels . CONCLUSION The effects of the polypill on blood pressure and lipid levels were less than anticipated , raising questions about the reliability of the reported compliance . There is a case for a fully powered trial of a polypill for the prevention of cardiovascular disease",
"Abstract Objective : To investigate whether a proactive multifactorial risk factor intervention strategy using single-pill amlodipine/atorvastatin ( 5/10 , 10/10 mg ) in addition to other antihypertensive and lipid-lowering therapy , as required , result ed in greater reduction in calculated Framingham 10-year coronary heart disease ( CHD ) risk compared with usual care ( UC ) after 52-weeks treatment . Research design and methods : Prospect i ve , multinational , open-label , cluster r and omized trial , with the investigator as the unit of r and omization . Eligible hypertensive patients were 35–79 years of age , with ≥3 additional cardiovascular risk factors , but no history of CHD and baseline total cholesterol ( TC ) ≤6.5 mmol/l . Clinical trial registration : Trial registration : Clinical Trials.gov identifier : NCT00407537 . Main outcome measure : The primary endpoint was calculated Framingham 10-year CHD risk at 52 weeks . Results : Of the 140 r and omized sites , 136 sites contributed 1461 patients . Mean baseline age and low-density lipoprotein cholesterol ( LDL-C ) were comparable between treatment arms . Mean baseline BP ( 150.3/89.7 vs. 144.3/86.5 mmHg ) and Framingham CHD risk ( 20.0 vs. 18.1 % ) were higher in the proactive intervention versus the UC arm ( p 52 , mean CHD risk was 12.5 % in the proactive intervention arm and 16.3 % in the UC arm ( p differences in systolic BP and in TC between the two arms . Overall , adverse events ( AEs ) were reported in 48.8 % and 44.0 % of patients in the proactive intervention and the UC arm , respectively . Although there were differences in the incidence of AEs between the treatment arms , the AE profile in the proactive intervention arm was consistent with previous safety experience for this medication . Conclusions : A proactive multifactorial risk factor intervention strategy that simultaneously treated both BP and cholesterol regardless of individual risk factors per se , is more effective in reducing calculated Framingham 10-year CHD risk than UC in patients with hypertension and additional risk factors",
"Background —This study explores health provider and patient attitudes toward the use of a cardiovascular polypill as a health service strategy to improve cardiovascular prevention . Methods and Results —In-depth , semistructured interviews ( n=94 ) were conducted with health providers and patients from Australian general practice , Aboriginal community-controlled and government-run Indigenous Health Services participating in a pragmatic r and omized controlled trial evaluating a polypill-based strategy for high-risk primary and secondary cardiovascular disease prevention . Interview topics included polypill strategy acceptability , factors affecting adherence , and trial implementation . Transcribed interview data were analyzed thematically and interpretively . Polypill patients commented frequently on cost-savings , ease , and convenience of a daily-dosing pill . Most providers considered a polypill strategy to facilitate improved patient medication use . Indigenous Health Services providers and indigenous patients thought the strategy acceptable and beneficial for indigenous patients given the high disease burden . Providers noted the inflexibility of the fixed dose regimen , with dosages sometimes inappropriate for patients with complex management considerations . Future polypill formulations with varied strengths and classes of medications may overcome this barrier . Many providers suggested the polypill strategy , in its current formulations , might be more suited to high-risk primary prevention patients . Conclusions —The polypill strategy was generally acceptable to patients and providers in cardiovascular prevention . Limitations to provider acceptability of this particular polypill were revealed , as was a perception it might be more suitable for high-risk primary prevention patients , though future combinations could facilitate its use in secondary prevention . Participants suggested a polypill-based strategy as particularly appropriate for lowering the high cardiovascular burden in indigenous population s. Clinical Trial Registration —URL : http://www.anzctr.org.au . ANZCTRN : 12608000583347",
"BACKGROUND Rosuvastatin , a lipid-lowering agent , has been widely used with olmesartan , a long-acting angiotensin II receptor blocker , indicated for the treatment of dyslipidemia accompanied by hypertension . A fixed-dose combination ( FDC ) tablet of these 2 drugs was recently developed to enhance the dosing convenience and to increase patient compliance while yielding pharmacokinetic profiles comparable to coadministration of each drug as individual tablets . OBJECTIVE The goal of present study was to compare the pharmacokinetic profiles of single-dose administration of an FDC tablet containing rosuvastatin/olmesartan 20/40 mg ( test formulation ) with coadministration of a rosuvastatin 20-mg tablet and a olmesartan 40-mg tablet ( reference formulation ) in healthy Korean male volunteers , for the purpose of determining bioequivalence . METHODS This single-dose , r and omized , open-label , 2-period crossover study enrolled subjects aged 20 to 50 years and within 20 % of ideal body weight . Each subject received a single dose of the test and reference formulations orally in a fasted state , with a 7-day washout period between the administrations . Blood sample s were collected up to 72 hours after dosing , and pharmacokinetic parameters were determined for rosuvastatin , its active metabolite ( N-desmethyl rosuvastatin ) , and olmesartan . Bioequivalence was concluded if the 90 % CIs of the geometric mean ratios for the primary pharmacokinetic parameters were within the predetermined range of 80 % to 125 % . Adverse events ( AEs ) were evaluated based on subject interviews and physical examinations . RESULTS Among the 58 enrolled subjects , 54 completed the study . The 90 % CIs of the geometric mean ratios of the primary pharmacokinetic parameters were as follows : rosuvastatin : AUC(last ) , 85.60 % to 97.40 % and C(max ) , 83.16 % to 98.21 % ; N-desmethyl rosuvastatin : AUC(last ) , 82.08 % to 93.45 % and C(max ) , 79.23 % to 93.41 % ; and olmesartan : AUC(last ) , 97.69 % to 105.69 % and C(max ) , 100.35 % to 109.42 % . The most frequently noted AE was headache , occurring in 3 and 6 patients with the test and reference formulations , respectively . All of the AEs were expected , and there was no significant difference in the prevalences of AEs between the 2 formulations . CONCLUSIONS The pharmacokinetic properties of the newly developed FDC tablet of rosuvastatin/olmesartan 20/40 mg suggest that it is bioequivalent to co-administration of each drug as individual tablets in these healthy Korean male subjects . The two formulations were well tolerated , with no serious AEs observed . Clinical Trials.gov identifier : NCT01823900",
"Abstract Objective : To compare the reduction in calculated Framingham 10 year coronary heart disease ( CHD ) risk after 52 weeks ’ intervention with a proactive multifactorial intervention ( PMI ) strategy ( based on single-pill amlodipine/atorvastatin [ SPAA ] ) versus continuing usual care ( UC ) ( based on investigators ' best clinical judgment ) among younger ( Research design and methods : Sub- analysis of the Cluster R and omized Usual Care versus Caduet Investigation Assessing Long-term risk ( CRUCIAL ) trial . Eligible patients had hypertension and ≥3 cardiovascular risk factors . Main outcome measure : Treatment-related reduction in calculated Framingham 10 year CHD risk between baseline and Week 52 in younger and older patients . Results : Nine hundred patients ( 63.5 % ) were had lower mean baseline CHD risk versus older patients ( 17.1 % vs. 22.6 % ) . A greater reduction in calculated CHD risk at Week 52 was observed in the PMI versus the UC arm in both younger ( −33.2 % vs. −2.9 % , p change from baseline in calculated CHD risk were similar in younger and older patients ( −26.3 % vs. −25.7 % , age interaction p = 0.887 ) . CHD risk reduction was slightly greater among younger men than younger women ( −29.3 vs. −23.9 , gender interaction p = 0.062 ) . A low proportion of patients discontinued the PMI strategy due to adverse events in both age groups ( 5.8 % vs. 6.1 % , respectively ) . Study limitations included ad-hoc ( not pre-specified ) sub-group analysis and short duration of follow-up . Conclusions : The PMI strategy based on the inclusion of SPAA in the treatment regimen is more effective than UC in reducing calculated CHD risk . This strategy may be considered as the treatment of choice in younger and older hypertensive patients with additional cardiovascular risk factors",
"The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ( ALLHAT ) consisted of 42,418 participants r and omized to one of four antihypertensive treatment groups : chlorthalidone , amlodipine , lisinopril , or doxazosin . A subset of these participants with fasting low-density lipoprotein cholesterol levels 100 - 189 mg/dL were r and omized into a lipid-lowering component : 5170 to receive pravastatin ( 40 mg daily ) and 5185 to receive usual care . This report describes the characteristics and lipid distribution of these participants . There were no important differences between the r and omized treatment groups . Women had higher total cholesterol , low-density lipoprotein cholesterol , and high-density lipoprotein cholesterol than men . There was a similar finding for black participants compared with whites , except blacks had lower triglycerides . Diabetics had lower high-density lipoprotein cholesterol and higher triglycerides than nondiabetics , and patients with body mass index higher high-density lipoprotein cholesterol but lower low-density lipoprotein cholesterol and triglycerides than patients with higher body mass index . The success of the r and omization of this large , diverse population and the differences in the lipid distributions among its subgroups will allow further underst and ing of optimal lipid-lowering treatment",
"Background and rationale In clinical practice , blood pressure (BP)-lowering agents are generally prescribed for use in the morning , whereas ( short-acting ) statins are recommended for use in the evening . There is evidence that the reduction in LDL cholesterol ( LDL-c ) achieved with short-acting statins is superior when taken in the evening and reported improvement in BP control when aspirin and BP-lowering agents are taken in the evening . However , it is unclear whether the additional reduction in LDL-c and BP is offset by a reduction in adherence , given that taking medication in the evening may be less typical or convenient . There is therefore uncertainty concerning the best timing of administration of a cardiovascular combination pill such as the polypill . Aim The aim of TEMPUS ( NCT01506505 ) , a prospect i ve r and omized open blinded endpoint ( PROBE ) crossover trial , is to evaluate whether there is a difference in LDL-c levels or 24-hour ambulatory BP in individuals at increased risk of cardiovascular disease when the cardiovascular polypill is taken in the evening compared to the morning . An additional aim is to assess the effect of the polypill on LDL-c and BP compared to the administration of separate pills of identically dosed components of the polypill . Methods In total 75 participants with established cardiovascular disease or an intermediate to high risk for cardiovascular disease are r and omly allocated to the sequence of three different treatments of 6–8 weeks : ( 1 ) the cardiovascular polypill ( aspirin 75 mg , simvastatin 40 mg , lisinopril 10 mg , and hydrochlorothiazide 12.5 mg ) in the evening ; ( 2 ) the polypill in the morning ; and ( 3 ) the use of the identically dosed agents in separate pills taken at different time points during the day . The primary endpoint is the difference in LDL-c and mean 24-hour ambulatory systolic BP . Secondary outcomes are the difference in relative risk reduction , biochemistry , platelet function and pulse wave analysis , participants ’ adherence , and acceptability . Conclusions TEMPUS will evaluate the effect of timing of the administration of a cardiovascular polypill on LDL-c and BP measurements in patients with an intermediate or high risk for cardiovascular disease",
"BACKGROUND Cardiovascular disease ( CVD ) is among the most common causes of mortality in all population s. Nonalcoholic steatohepatitis is a common finding in patients with CVD . Prevention of CVD in individual patients typically requires periodic clinical evaluation , as well as diagnosis and management of risk factors such as hypertension and hyperlipidemia . However , this is re source consuming and hard to implement , especially in developing countries . We design ed a study to investigate the effects of a simpler strategy : a fixed-dose combination pill consisting of aspirin , valsartan , atorvastatin and hydrochlorthiazide ( PolyPill ) in an unselected group of persons aged over 50 years . DESIGN The PolyIran-Liver study was performed in Gonbad city as an open label pragmatic r and omized controlled trial nested within the Golestan Cohort Study . We r and omly selected 2,400 cohort study participants aged above 50 years , r and omly assigned them to intervention or usual care and invited them to participate in an additional measurement study ( if they met the eligibility criteria ) to measure liver related outcomes . Those agreeing and r and omized to the intervention arm were offered a daily single dose of PolyPill . We will follow participants for 5 years . The primary outcome is major cardiovascular events , secondary outcomes include all-cause mortality and liver related outcomes : liver stiffness and liver enzyme levels . Cardiovascular outcomes and mortality will be determined from the cohort study and liver-related outcomes in those consenting to follow up . Analysis will be by allocated group . TRIAL STATUS Between October and December 2011 , 1,320 intervention and 1,080 control participants were invited to participate in the additional measurement study . For all these participants , the major cardiovascular events will be determined using blind assessment of outcomes through the cohort study . In the intervention and control arms , 875 ( 66 % ) and 721 ( 67 % ) respectively , met the eligibility criteria and agreed to participate in the additional measurement study . Liver related outcomes will be measured in these participants . Of the 1,320 participants r and omized to the intervention , 787 ( 60 % ) accepted the PolyPill . CONCLUSION The PolyIran-liver urban study will provide us with important information on the effectiveness of PolyPill on major cardiovascular events , all-cause mortality and liver related outcomes . ( Clinical Trials.gov ID : NCT01245608 )",
"TOGETHER investigated whether targeting multiple cardiovascular ( CV ) risk factors using single-pill amlodipine/atorvastatin ( AML/ATO ) and therapeutic lifestyle changes ( TLC ) results in greater blood pressure (BP)/lipid control and additional reduction in estimated cardiovascular disease ( CVD ) risk compared with blood pressure intervention only using amlodipine ( AML ) + TLC . TOGETHER was a 6-week , r and omized , double-blind , double-dummy trial using hypertensive participants with additional CV risk factors without CVD/diabetes . Participants were r and omized to either AML/ATO ( 5 to 10/20 mg ) + TLC or AML ( 5 to 10 mg ) + TLC . The primary end point was the difference in proportion of participants attaining both BP ( ( goals at week 6 . At week 6 , 67.8 % of participants receiving AML/ATO + TLC attained the combined BP/LDL-C goal versus 9.6 % with AML + TLC ( RD [ A – B ] : 58.2 ; 95 % CI [ 48.1 to 68.4 ] P in LDL-C , total cholesterol and triglycerides and estimated 10-year Framingham risk were also observed . Treatment with AML/ATO was well tolerated . In conclusion , a multifactorial CV management approach is more effective in achieving combined BP/LDL-C targets as well as CV risk reduction compared with BP intervention only in this patient population",
"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",
"Purpose of review To review the risk of cardiovascular complications in HIV-infected patients receiving combination antiretroviral treatment . Recent findings Recent data suggest that patients with chronic HIV infection will require continuous lifelong combination antiretroviral treatment , which may increase the risk of cardiovascular disease in all population s by substantial amounts . Simple , safe and effective interventions to reduce cardiovascular complications in HIV-infected patients will be required . Studies in the general population suggest that the primary prevention of cardiovascular disease with a pill combining blood-pressure-lowering , cholesterol-lowering and antiplatelet treatments ( a polypill ) might decrease cardiovascular events . An HIV polypill study with 8000 HIV-infected patients with a moderate risk of cardiovascular disease r and omized to either a polypill of low-dose pravastatin , aspirin , hydrochlorothiazide and lisinopril or to placebo is described . The primary clinical endpoint would be a composite of cardiovascular mortality , non-fatal myocardial infa rct ion and stroke . A vanguard study of 400 patients could assess changes in cholesterol , blood pressure and other risk factors . The clinical endpoint study described would have 80 % power to detect a 23 % reduction in the rate of cardiovascular events in the polypill arm . Summary A study of a polypill like that proposed for the general population will provide crucial information on the risks and benefits of primary cardiovascular prevention in HIV-infected patients",
"BACKGROUND The PolyIran study is a large-scale pragmatic cluster r and omized controlled trial of fixed-dose combination therapy ( Polypill ) for prevention of cardiovascular diseases ( CVD ) in Iran . The PolyIran Quality Control Program ( PIQCP ) including a new question naire was developed to assess the quality of data collection during follow-up visits . The aim of this study was to assess the inter-rater reliability of PIQCP question naire . METHODS The study was conducted in 26 ( 11 % ) r and omly selected clusters ( from a total of 236 PolyIran clusters ) . All participants within these 26 clusters were enrolled . The quality scores were measured according to the PIQCP guidelines by two independent raters . The intraclass correlation coefficients ( ICC ) were measured . In addition , the quality scores were categorized into good ( 70 % ) and poor ( The kappa coefficient was used to assess inter-rater agreement for this categorical quality scores . RESULTS A total number of 945 PolyIran participants were enrolled of which , 501 ( 53 % ) were from intervention arm . In 934 participants ( 98.8 % ) , the quality score could be successfully identified by both raters . The ICC ( 95%CI ) of the overall quality scores was 0.985 ( 0.983 - 0.987 ) . It was 0.976 ( 0.972 - 0.980 ) and 0.988 ( 0.986 - 0.990 ) in intervention and control arms , respectively . We found excellent agreement between the two raters in identifying participants with good and poor quality scores ( kappa = 0.988 , P The kappa values were 0.972 ( P < 0.001 ) and 1.000 ( P < 0.001 ) in intervention and control arms , respectively . DISCUSSION Our results suggested that the PIQCP question naire is a reliable tool for assessing quality of data collection in PolyIran follow-up visits . Using this measure will help us in efficient monitoring of the PolyIran follow-ups and may ensure high quality data",
"BACKGROUND Type 2 diabetes is associated with a substantially increased risk of cardiovascular disease , but the role of lipid-lowering therapy with statins for the primary prevention of cardiovascular disease in diabetes is inadequately defined . We aim ed to assess the effectiveness of atorvastatin 10 mg daily for primary prevention of major cardiovascular events in patients with type 2 diabetes without high concentrations of LDL-cholesterol . METHODS 2838 patients aged 40 - 75 years in 132 centres in the UK and Irel and were r and omised to placebo ( n=1410 ) or atorvastatin 10 mg daily ( n=1428 ) . Study entrants had no documented previous history of cardiovascular disease , an LDL-cholesterol concentration of 4.14 mmol/L or lower , a fasting triglyceride amount of 6.78 mmol/L or less , and at least one of the following : retinopathy , albuminuria , current smoking , or hypertension . The primary endpoint was time to first occurrence of the following : acute coronary heart disease events , coronary revascularisation , or stroke . Analysis was by intention to treat . FINDINGS The trial was terminated 2 years earlier than expected because the prespecified early stopping rule for efficacy had been met . Median duration of follow-up was 3.9 years ( IQR 3.0 - 4.7 ) . 127 patients allocated placebo ( 2.46 per 100 person-years at risk ) and 83 allocated atorvastatin ( 1.54 per 100 person-years at risk ) had at least one major cardiovascular event ( rate reduction 37 % [ 95 % CI -52 to -17 ] , p=0.001 ) . Treatment would be expected to prevent at least 37 major vascular events per 1000 such people treated for 4 years . Assessed separately , acute coronary heart disease events were reduced by 36 % ( -55 to -9 ) , coronary revascularisations by 31 % ( -59 to 16 ) , and rate of stroke by 48 % ( -69 to -11 ) . Atorvastatin reduced the death rate by 27 % ( -48 to 1 , p=0.059 ) . No excess of adverse events was noted in the atorvastatin group . INTERPRETATION Atorvastatin 10 mg daily is safe and efficacious in reducing the risk of first cardiovascular disease events , including stroke , in patients with type 2 diabetes without high LDL-cholesterol . No justification is available for having a particular threshold level of LDL-cholesterol as the sole arbiter of which patients with type 2 diabetes should receive statins . The debate about whether all people with this disorder warrant statin treatment should now focus on whether any patients are at sufficiently low risk for this treatment to be withheld",
"OBJECTIVE To measure the costs of a polypill strategy and compare them with those of usual care in people with established cardiovascular disease ( CVD ) or at similarly high cardiovascular risk . DESIGN A within-trial cost analysis of polypill-based care versus usual care with separate medications , using data from the Kanyini Guidelines Adherence with the Polypill ( GAP ) trial and linked health service and medication administrative cl aims data . PARTICIPANTS Kanyini GAP participants who consented to Australian Medicare record access . MAIN OUTCOME MEASURES Mean health service and pharmaceutical expenditure per patient per year , estimated with generalised linear models . Costs during the trial ( r and omisation January 2010 - May 2012 , median follow-up 19 months , maximum follow-up 36 months ) were inflated to 2012 costs . RESULTS Our analysis showed a statistically significantly lower mean pharmaceutical expenditure of $ 989 ( 95 % CI , $ 648-$1331 ) per patient per year in the polypill arm compared with usual care ( P health service expenditure . CONCLUSIONS This study provides evidence of significant cost savings to the taxpayer and Australian Government through the introduction of a CVD polypill strategy . The savings will be less now than during the trial due to subsequent reductions in the costs of usual care . Nonetheless , given the prevalence of CVD in Australia , the introduction of this polypill could increase considerably the efficiency of health care expenditure in Australia . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Registry ACTRN126080005833347",
"Guidelines stress the importance of the simultaneous management of multiple cardiovascular risk factors . This can in part be achieved by coadministration of lipid-lowering and antihypertensive treatments . Potential pharmacodynamic interaction between drugs should be investigated as part of developing single-pill combinations . The Respond trial assessed whether combining amlodipine to treat hypertension and atorvastatin to treat dyslipidemia affected the action of either monotherapy . A total of 1660 hypertensive patients with dyslipidemia received 1 of 15 combinations of amlodipine ( placebo , 5 , or 10 mg ) and atorvastatin ( placebo , 10 , 20 , 40 , or 80 mg ) in a 3 x 5 factorial r and omized , placebo-controlled design . At 8 weeks , combination-treated patients experienced dose-related and statistically significant reductions in systolic blood pressure , low-density lipoprotein cholesterol , and Framingham risk score . Overall , coadministered atorvastatin and amlodipine was well tolerated and without adverse pharmacodynamic interaction ; combination treatment did not affect the low-density lipoprotein cholesterol-lowering efficacy and safety of atorvastatin , or the systolic blood pressure-lowering efficacy and safety of amlodipine",
"The use of preventive medications in people at high risk of cardiovascular disease is conceptually straightforward , yet in practice the adoption of such measures is disappointingly low , plus there is wide international variation in preventive therapies . Several barriers might explain this shortfall and variation , but the simplicity and economy of a polypill-based strategy might overcome some barriers . The ‘ Use of a Multidrug Pill In Reducing cardiovascular Events ’ ( UMPIRE ) trial assesses whether a polypill strategy ( by combining aspirin , a statin and two blood pressure lowering agents ) would improve adherence to guideline -indicated therapies and would lower both blood pressure and cholesterol , in people with established cardiovascular disease . UMPIRE , running in India and three European countries ( Engl and , Irel and and the Netherl and s ) , is an open , r and omised , controlled trial design ed to include 1000 participants in India and 1000 in Europe , with a followup of 12–24 months . Participants were r and omised to one of two versions of the polypill or relegated to usual care . The primary study outcomes were the self-reported use of aspirin , a statin and at least two blood pressure lowering agents ; as well as changes in blood pressure and cholesterol . Secondary outcomes included : any cardiovascular events , reasons for stopping medications , serious adverse events and perceived changes in quality of life . Interpretation of the study data will be enhanced by health , economic and process-related evaluations . UMPIRE is registered with the European Clinical Trials data base , as EudraCT : 2009 - 016278 - 34 and the Clinical Trials Registry , India as CTRI/2010/091/000250 . The trial was part of the ‘ Single Pill Against Cardiovascular Events ( SPACE ) ’ collaboration , which encompasses the ‘ IMProving Adherence using Combination Therapy ( IMPACT ) ’ and ‘ Kanyini Guidelines Adherence with the Polypill ( Kanyini-GAP ) ’ trials",
"Objective The purpose of this study was to investigate the consistency of the proportional effect of fixed-dose combination therapy ( the ‘ polypill ’ ) on the use of recommended cardiovascular preventative medications among indigenous Māori and non-indigenous adults in New Zeal and . Methods We r and omised Māori and non-Māori primary care patients at high risk of cardiovascular disease ( either because of a prior event or with an estimated 5-year risk of a first event of at least 15 % ) to a polypill ( containing aspirin , statin and two antihypertensives ) or usual care for a minimum of 12 months . All patients had indications for all polypill components according to their general practitioner , and all medications ( including the polypill ) were prescribed by the patient ’s general practitioner and dispensed at community pharmacies . The main outcome for this study was the use of all recommended medications ( antiplatelet , statin and two antihypertensives ) at 12 months . Heterogeneity in the effect of polypill-based care compared with usual care on this outcome by ethnicity was assessed by logistic regression . Results Baseline use of recommended medications was 36 % ( 93/257 ) among Māori and 51 % ( 130/156 ) among non-Māori participants . Polypill-based care was associated with an increase in the use of recommended medications among Māori ( relative risk [ RR ] : 1.87 ; 95 % confidence interval [ CI ] : 1.50–2.34 ) and non-Māori ( RR : 1.66 ; 95 % CI : 1.37–2.00 ) when compared with usual care at 12 months , and there was no statistically significant heterogeneity in this outcome by ethnicity ( p = 0.92 ) . Conclusion Polypill-based care is likely to reduce absolute inequities between Māori and non-Māori in the use of recommended cardiovascular preventative medications given baseline absolute differences and the consistency of the proportional effect of this intervention by ethnicity in this pragmatic trial in primary care",
"OBJECTIVE To identify facilitators and barriers to clinical trial implementation in Aboriginal health services . DESIGN Indepth interview study with thematic analysis . SETTING Six Aboriginal community-controlled health services and one government-run service involved in the Kanyini Guidelines Adherence with the Polypill ( KGAP ) study , a pragmatic r and omised controlled trial that aim ed to improve adherence to indicated drug treatments for people at high risk of cardiovascular disease . PARTICIPANTS 32 health care providers and 21 Aboriginal and Torres Strait Isl and er patients . RESULTS A fundamental enabler was that participants considered the research to be governed and endorsed by the local health service . That the research was perceived to address a health priority for communities was also highly motivating for both providers and patients . Enlisting the support of Aboriginal and Torres Strait Isl and er staff champions who were visible to the community as the main source of information about the trial was particularly important . The major implementation barrier for staff was balancing their service delivery roles with adherence to often highly dem and ing trial-related procedures . This was partially alleviated by the research team 's provision of onsite support and attempts to make trial processes more streamlined . Although more intensive support was highly desired , there were usually insufficient re sources to provide this . CONCLUSION Despite strong community and health service support , major investments in time and re sources are needed to ensure successful implementation and minimal disruption to already overstretched , routine services . Trial budgets will necessarily be inflated as a result . Funding agencies need to consider these additional re source dem and s when supporting trials of a similar nature",
"Objective To evaluate whether provision of fixed dose combination treatment improves adherence and risk factor control compared with usual care of patients at high risk of cardiovascular disease in primary care . Design Open label r and omised control trial : IMPACT ( IMProving Adherence using Combination Therapy ) . Setting 54 general practice s in the Auckl and and Waikato regions of New Zeal and , July 2010 to August 2013 . Participants 513 adults ( including 257 indigenous Māori ) at high risk of cardiovascular disease ( established cardiovascular disease or five year risk ≥15 % ) who were recommended for treatment with antiplatelet , statin , and two or more blood pressure lowering drugs . 497 ( 97 % ) completed 12 months ’ follow-up . Interventions Participants were r and omised to continued usual care or to fixed dose combination treatment ( with two versions available : aspirin 75 mg , simvastatin 40 mg , and lisinopril 10 mg with either atenolol 50 mg or hydrochlorothiazide 12.5 mg ) . All drugs in both treatment arms were prescribed by their usual general practitioners and dispensed by local community pharmacists . Main outcome measures Primary outcomes were self reported adherence to recommended drugs ( antiplatelet , statin , and two or more blood pressure lowering agents ) and mean change in blood pressure and low density lipoprotein cholesterol at 12 months . Results Adherence to all four recommended drugs was greater among fixed dose combination than usual care participants at 12 months ( 81 % v 46 % ; relative risk 1.75 , 95 % confidence interval 1.52 to 2.03 , P ) . Adherence for each drug type at 12 months was high in both groups but especially in the fixed dose combination group : for antiplatelet treatment it was 93 % fixed dose combination v 83 % usual care ( P combination blood pressure lowering 89 % v 59 % ( P any blood pressure lowering 96 % v 91 % ( P=0.02 ) . Self reported adherence was highly concordant with dispensing data ( dispensing of all four recommended drugs 79 % fixed dose combination v 47 % usual care , relative risk 1.67 , 95 % confidence interval 1.44 to 1.93 , P in risk factor control between the fixed dose combination and usual care groups over 12 months : the difference in systolic blood pressure was −2.2 mm Hg ( −4.5 v −2.3 , 95 % confidence interval −5.6 to 1.2 , P=0.21 ) , in diastolic blood pressure −1.2 mm Hg ( −2.1 v −0.9 , −3.2 to 0.8 , P=0.22 ) and in low density lipoprotein cholesterol −0.05 mmol/L ( −0.20 v −0.15 , −0.17 to 0.08 , P=0.46 ) . The number of participants with cardiovascular events or serious adverse events was similar in both treatment groups ( fixed dose combination 16 v usual care 18 ( P=0.73 ) , 99 v 93 ( P=0.56 ) , respectively ) . Fixed dose combination treatment was discontinued in 94 participants ( 37 % ) . The most commonly reported reason for discontinuation was a side effect ( 54/75 , 72 % ) . Overall , 89 % ( 227/256 ) of fixed dose combination participants ’ general practitioners completed a post-trial survey , and the fixed dose combination strategy was rated as satisfactory or very satisfactory for starting treatment ( 206/227 , 91 % ) , blood pressure control ( 180/220 , 82 % ) , cholesterol control ( 170/218 , 78 % ) , tolerability ( 181/223 , 81 % ) , and prescribing according to local guidelines ( 185/219 , 84 % ) . When participants were asked at 12 months how easy they found taking their prescribed drugs , most responded very easy or easy ( 224/246 , 91 % fixed dose combination v 212/246 , 86 % usual care , P=0.09 ) . At 12 months the change in other lipid fractions , difference in EuroQol-5D , and difference in barriers to adherence did not differ significantly between the treatment groups . Conclusions Among this well treated primary care population , fixed dose combination treatment improved adherence to the combination of all recommended drugs but improvements in clinical risk factors were small and did not reach statistical significance . Acceptability was high for both general practitioners and patients , although the discontinuation rate was high . Trial registration Australian New Zeal and Clinical Trial Registry ACTRN12606000067572",
"BACKGROUND Cardiovascular disease ( CVD ) is the leading cause of death , and principal reason for the large difference in life expectancy between indigenous Māori and the non-indigenous population in New Zeal and . CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin , blood pressure lowering and lipid lowering therapies . However , prescribing and adherence rates are low and CVD events remain high . AIM To assess whether a medication strategy using a fixed dose combination pill ( ' polypill ' ) could improve prescribing and adherence to recommended medications , lower blood pressure and improve lipids compared with current care over 12 months . METHODS IMProving Adherence using Combination Therapy ( IMPACT ) is an open-label r and omised controlled trial comparing a once-daily polypill containing four preventive medications with usual care . Six hundred participants who have had previous CVD events or are at high risk of CVD will be enrolled , including 300 Māori . Participants are identified , enrolled and prescribed either the polypill or current medications at their usual primary health care practice , with medications ( including the polypill ) dispensed through local community pharmacies . The polypill contains 75 mg aspirin , 40 mg simvastatin , 10 mg lisinopril and either 12.5 mg hydrochlorothiazide or 50 mg atenolol . Primary outcomes are adherence to guidelines -recommended medications and changes in systolic blood pressure and low density lipoprotein at 12 months . Secondary outcomes include other lipids , medication dispensing , barriers to adherence , CVD and other serious adverse events , quality of life and prescriber acceptability . The trial is registered with the Australian New Zeal and Clinical Trial Registry ( ACTRN12606000067572 )",
"Abstract Objective : To compare the change in calculated coronary heart disease ( CHD ) risk using a proactive multifactorial intervention ( PMI ) versus usual care ( UC ) , among Latin-American ( LA ) and non-LA patients enrolled in the CRUCIAL trial . Research design and methods : This is a sub- analysis of the Cluster R and omized Usual Care versus Caduet Investigation Assessing Long-term-risk ( CRUCIAL ) trial . CRUCIAL was a prospect i ve , multinational , open-label , cluster-r and omized trial . Eligible patients had hypertension and ≥3 additional cardiovascular risk factors , but no history of CHD and baseline total cholesterol ≤6.5 mmol/l ( 250 mg/dl ) . The PMI strategy was implemented by the inclusion of single-pill amlodipine/atorvastatin ( SPAA ) in the patients ’ treatment regimen . Overall , 20 % of patients resided in the LA region . Main outcome measure : Treatment-related change in calculated Framingham 10-year CHD risk between baseline and Week 52 in the LA and non-LA regions . Results : A greater relative reduction in calculated CHD risk after 52 weeks ’ follow-up was observed for patients in the PMI arm compared with UC arm in both LA ( −32.8 % vs. −7.5 % , p = 0.003 ) and non-LA regions ( −33.1 % vs. −3.3 % , p The proportion of patients discontinuing treatment in the PMI arm due to adverse events ( AEs ) was low in both regions ( both 5.9 % ) . Conclusions : The PMI approach based on the inclusion of SPAA in the patients ’ treatment regimen may improve the management of CHD risk among patients residing in LA and non-LA regions . Clinicians may be reassured by the low rate of AEs leading to discontinuation of SPAA in both regions",
"To assess the combined influence of blood pressure ( BP ) , serum cholesterol level , and cigarette smoking on death from coronary heart disease ( CHD ) and to describe how these associations vary with age , data on those factors and on mortality for 316,099 men screened for the Multiple Risk Factor Intervention Trial ( MRFIT ) were examined . Vital status of participants has been determined after an average follow-up of 12 years ; 6327 deaths from CHD have been identified . Strong grade d relationships between serum cholesterol levels above 4.65 mmol/L ( 180 mg/dL ) , systolic BP above 110 mm Hg , and diastolic BP above 70 mm Hg and mortality due to CHD were evident . Smokers with serum cholesterol and systolic BP levels in the highest quintiles had CHD death rates that were approximately 20 times greater than nonsmoking men with systolic BP and cholesterol levels in the lowest quintile . Systolic and diastolic BP , serum cholesterol level , and cigarettes per day were significant predictors of death due to CHD in all age groups . Systolic BP was a stronger predictor than diastolic BP . These results , together with the findings of clinical trials , offer strong support for intensified preventive efforts in all age groups",
"BACKGROUND Cardiovascular morbidity is a major burden in patients with type 2 diabetes . In the Steno-2 Study , we compared the effect of a targeted , intensified , multifactorial intervention with that of conventional treatment on modifiable risk factors for cardiovascular disease in patients with type 2 diabetes and microalbuminuria . METHODS The primary end point of this open , parallel trial was a composite of death from cardiovascular causes , nonfatal myocardial infa rct ion , nonfatal stroke , revascularization , and amputation . Eighty patients were r and omly assigned to receive conventional treatment in accordance with national guidelines and 80 to receive intensive treatment , with a stepwise implementation of behavior modification and pharmacologic therapy that targeted hyperglycemia , hypertension , dyslipidemia , and microalbuminuria , along with secondary prevention of cardiovascular disease with aspirin . RESULTS The mean age of the patients was 55.1 years , and the mean follow-up was 7.8 years . The decline in glycosylated hemoglobin values , systolic and diastolic blood pressure , serum cholesterol and triglyceride levels measured after an overnight fast , and urinary albumin excretion rate were all significantly greater in the intensive-therapy group than in the conventional-therapy group . Patients receiving intensive therapy also had a significantly lower risk of cardiovascular disease ( hazard ratio , 0.47 ; 95 percent confidence interval , 0.24 to 0.73 ) , nephropathy ( hazard ratio , 0.39 ; 95 percent confidence interval , 0.17 to 0.87 ) , retinopathy ( hazard ratio , 0.42 ; 95 percent confidence interval , 0.21 to 0.86 ) , and autonomic neuropathy ( hazard ratio , 0.37 ; 95 percent confidence interval , 0.18 to 0.79 ) . CONCLUSIONS A target-driven , long-term , intensified intervention aim ed at multiple risk factors in patients with type 2 diabetes and microalbuminuria reduces the risk of cardiovascular and microvascular events by about 50 percent",
"The AVALON study was a r and omized , multicenter trial to assess the efficacy and safety of coadministered amlodipine and atorvastatin in patients with hypertension and dyslipidemia . Phase one was an 8-week , double-blind , double-dummy , placebo-controlled period whereby patients received amlodipine 5 mg , atorvastatin 10 mg , amlodipine 5 mg and atorvastatin 10 mg , or placebo . Thereafter , all patients received single-blind amlodipine 5 mg and atorvastatin 10 mg for 8-weeks , followed by 12 weeks of open-label treatment where doses could be titrated to improve low-density lipoprotein cholesterol and blood pressure control . A total of 847 patients entered the double-blind phase . At Week 8 , 45 % of the patients receiving amlodipine 5 mg and atorvastatin 10 mg reached both their blood pressure and low-density lipoprotein cholesterol goals , compared with 8.3 % with amlodipine ( p atorvastatin ( p placebo . At 28 weeks , 67.1 % of patients coadministered amlodipine and atorvastatin ( mean doses , 7.6 mg and 28.4 mg , respectively ) achieved both targets . Framingham estimated 10-year risk of coronary heart disease declined from baseline levels of 15.1 % to 6.9 % at Week 28 . Following coadministered treatment , the adverse events reported were similar to either agent alone . Concomitant administration of amlodipine and atorvastatin is an effective and well tolerated treatment for coexisting hypertension and dyslipidemia",
"AIMS Cardiovascular polypills are a novel strategy in the prevention of cardiovascular disease . Based on considerations about the effectiveness , the individual pills of a polypill are taken at different times of the day . This study aim ed therefore to compare the use of a polypill in the morning , in the evening or the individual components taken at their usual times on cardiovascular risk factors and patient acceptability . METHODS The study was a r and omized three-period crossover trial . Seventy-eight patients with established cardiovascular disease were r and omly allocated to the use of polypill ( aspirin 75 mg , simvastatin 40 mg , lisinopril 10 mg and hydrochlorothiazide 12.5 mg ) in the morning , in the evening or use of the individual agents taken at different time points ( Trial : NCT01506505 ) . RESULTS Using the polypill in the evening result ed in a 0.2 mmol/L ( 95%-confidence interval ( CI ) : 0.1 to 0.3 ) lower fasting LDL-cholesterol compared to the use in the morning , and not statistically significantly different mean 24-hour systolic BP ( mean difference : 0.7 mmHg ; 95%-CI ; -2.1 to 3.4 ) . Compared to the use of the individual agents , the mean LDL-cholesterol was 0.2 mmol/L ( 95%-CI : 0.1 to 0.3 ) higher when using the polypill in the morning , but not statistically significantly different when used in the evening ( mean difference : -0.1 mmol/L ; 95%-CI : -0.1 to 0.0 ) . Furthermore , there were no differences in mean 24-hour systolic BP with morning use ( mean difference : 0.4 mmHg ; 95%-CI ; -1.5 to 2.3 ) or evening use ( mean difference : 1.0mmHg ; 95%-CI ; -0.8 to 2.8 ) of the polypill compared to the individual agents . The adherence was 5.2 % ( 95%-CI : 1.4 to 9.1 ) higher with morning use of the polypill and 5.0 % ( 95%-CI : 1.5 to 8.5 ) higher with evening use compared to the individual agents . Treatment with the polypill was preferred by 92 % of the participants . CONCLUSION The use of a polypill in the evening was more effective in lowering LDL-cholesterol , and result ed in not statistically significantly different ambulatory BP levels compared to the use of a polypill in the morning . Therapy with a polypill was associated with an increased adherence . The polypill is highly preferred by patients , demonstrating a potential role for the polypill in the prevention of cardiovascular disease",
"CONTEXT Blood homocysteine levels are positively associated with cardiovascular disease , but it is uncertain whether the association is causal . OBJECTIVE To assess the effects of reducing homocysteine levels with folic acid and vitamin B(12 ) on vascular and nonvascular outcomes . DESIGN , SETTING , AND PATIENTS Double-blind r and omized controlled trial of 12,064 survivors of myocardial infa rct ion in secondary care hospitals in the United Kingdom between 1998 and 2008 . INTERVENTIONS 2 mg folic acid plus 1 mg vitamin B(12 ) daily vs matching placebo . MAIN OUTCOME MEASURES First major vascular event , defined as major coronary event ( coronary death , myocardial infa rct ion , or coronary revascularization ) , fatal or nonfatal stroke , or noncoronary revascularization . RESULTS Allocation to the study vitamins reduced homocysteine by a mean of 3.8 micromol/L ( 28 % ) . During 6.7 years of follow-up , major vascular events occurred in 1537 of 6033 participants ( 25.5 % ) allocated folic acid plus vitamin B(12 ) vs 1493 of 6031 participants ( 24.8 % ) allocated placebo ( risk ratio [ RR ] , 1.04 ; 95 % confidence interval [ CI ] , 0.97 - 1.12 ; P = .28 ) . There were no apparent effects on major coronary events ( vitamins , 1229 [ 20.4 % ] , vs placebo , 1185 [ 19.6 % ] ; RR , 1.05 ; 95 % CI , 0.97 - 1.13 ) , stroke ( vitamins , 269 [ 4.5 % ] , vs placebo , 265 [ 4.4 % ] ; RR , 1.02 ; 95 % CI , 0.86 - 1.21 ) , or noncoronary revascularizations ( vitamins , 178 [ 3.0 % ] , vs placebo , 152 [ 2.5 % ] ; RR , 1.18 ; 95 % CI , 0.95 - 1.46 ) . Nor were there significant differences in the numbers of deaths attributed to vascular causes ( vitamins , 578 [ 9.6 % ] , vs placebo , 559 [ 9.3 % ] ) or nonvascular causes ( vitamins , 405 [ 6.7 % ] , vs placebo , 392 [ 6.5 % ] ) or in the incidence of any cancer ( vitamins , 678 [ 11.2 % ] , vs placebo , 639 [ 10.6 % ] ) . CONCLUSION Substantial long-term reductions in blood homocysteine levels with folic acid and vitamin B(12 ) supplementation did not have beneficial effects on vascular outcomes but were also not associated with adverse effects on cancer incidence . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N74348595",
"BACKGROUND The combination of three blood-pressure-lowering drugs at low doses , with a statin , aspirin , and folic acid ( the polypill ) , could reduce cardiovascular events by more than 80 % in healthy individuals . We examined the effect of the Polycap on blood pressure , lipids , heart rate , and urinary thromboxane B2 , and assessed its tolerability . METHODS In a double-blind trial in 50 centres in India , 2053 individuals without cardiovascular disease , aged 45 - 80 years , and with one risk factor were r and omly assigned , by a central secure website , to the Polycap ( n=412 ) consisting of low doses of thiazide ( 12.5 mg ) , atenolol ( 50 mg ) , ramipril ( 5 mg ) , simvastatin ( 20 mg ) , and aspirin ( 100 mg ) per day , or to eight other groups , each with about 200 individuals , of aspirin alone , simvastatin alone , hydrochlorthiazide alone , three combinations of the two blood-pressure-lowering drugs , three blood-pressure-lowering drugs alone , or three blood-pressure-lowering drugs plus aspirin . The primary outcomes were LDL for the effect of lipids , blood pressure for antihypertensive drugs , heart rate for the effects of atenolol , urinary 11-dehydrothromboxane B2 for the antiplatelet effects of aspirin , and rates of discontinuation of drugs for safety . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00443794 . FINDINGS Compared with groups not receiving blood-pressure-lowering drugs , the Polycap reduced systolic blood pressure by 7.4 mm Hg ( 95 % CI 6.1 - 8.1 ) and diastolic blood pressure by 5.6 mm Hg ( 4.7 - 6.4 ) , which was similar when three blood-pressure-lowering drugs were used , with or without aspirin . Reductions in blood pressure increased with the number of drugs used ( 2.2/1.3 mm Hg with one drug , 4.7/3.6 mm Hg with two drugs , and 6.3/4.5 mm Hg with three drugs ) . Polycap reduced LDL cholesterol by 0.70 mmol/L ( 95 % CI 0.62 - 0.78 ) , which was less than that with simvastatin alone ( 0.83 mmol/L , 0.72 - 0.93 ; p=0.04 ) ; both reductions were greater than for groups without simvastatin ( p reductions in heart rate with Polycap and other groups using atenolol were similar ( 7.0 beats per min ) , and both were significantly greater than that in groups without atenolol ( p reductions in 11-dehydrothromboxane B2 were similar with the Polycap ( 283.1 ng/mmol creatinine , 95 % CI 229.1 - 337.0 ) compared with the three blood-pressure-lowering drugs plus aspirin ( 350.0 ng/mmol creatinine , 294.6 - 404.0 ) , and aspirin alone ( 348.8 ng/mmol creatinine , 277.6 - 419.9 ) compared with groups without aspirin . Tolerability of the Polycap was similar to that of other treatments , with no evidence of increasing intolerability with increasing number of active components in one pill . INTERPRETATION This Polycap formulation could be conveniently used to reduce multiple risk factors and cardiovascular risk",
"BACKGROUND The ultimate goal of antihypertensive therapy is cardiovascular risk ( CVR ) reduction . The aim of this study was to compare the efficacy and safety of once-daily fixed combination ( ODFC ) versus free-drug combination ( FDC ) of 3antihypertensive agents and statin . METHODS The ALL-IN-ONE trial was a 12-week r and omized , prospect i ve , multicenter trial . A total of 305 hypertensive patients were r and omized 1:1 . The \" fixed group \" was given an ODFC of perindropil 10 mg plus indapamide 2.5 mg plus amlodipine 5 or 10 mg plus atorvastatin 20 mg . The \" free group \" was given a FDC of the 3antihypertensive agents plus atorvastatin 20 mg . Primary end-points were the differences in clinic BP , cholesterol levels and CVR risk between the 2 groups after treatments . Secondary end-points included intragroup differences in clinic BP . Safety and compliance were also assessed . RESULTS At 12-weeks , the fixed group had lower systolic BP and similar diastolic BP compared to the free group . BP targets at week 12 were more commonly reached with fixed than free combination ( 89 % and 80 % respectively , p=0.048 ) . For cholesterol serum in both groups there was a significant reduction of values . Also CVR reduction was greater in those taking ODF . Safety was not significantly different between the 2 groups . Conversely , compliance was significantly greater in the fixed-group vs. the free-group . CONCLUSION This r and omized trial shows that ODF combination of perindropil , indapamide and amlodipine is as safe as free combination of the 3 drugs , but is associated with a greater efficacy in BP control , compliance and , associated with statin , in cholesterol reduction . A better cardiovascular risk control is achieved with ODF combination than with a free administration . Clinical Trials.gov ID : NCT02710539",
"Background and design : The effects of aspirin on blood pressure ( BP ) are controversial and a chronopharmacological effect of aspirin on 24-hour BP was reported recently in otherwise untreated hypertensive patients . The study was design ed to test the timing effect of aspirin dosing on 24-hour BP in treated hypertensive patients routinely taking aspirin for cardiovascular prevention . Method and results : Seventy-five patients were r and omized into two groups . One group was to receive aspirin in the evening then in the morning for 1 month and the other group in the morning then in the evening , following a cross-over design . The principal assessment criterion was 24-hour systolic BP ( SBP ) measured by 24-hour ambulatory BP monitoring ( ABPM ) . Patients were aged 65 ± 9 years and had been hypertensive for 12 ± 10 years . They were all taking a mean of 2.8 antihypertensive drugs and did not modify their treatment throughout the study . Of the included subjects , 70 % were men and 33 % were diabetics . Mean 24-hour SBP values were clinical ly equivalent and were not statistically different , depending on whether the aspirin was taking in the morning or evening ( 128.3 ± 1.4 vs. 128.3 ± 1.4 mmHg , respectively ) . Neither was there any significant difference in diurnal and nocturnal SBP or in 24-hour , diurnal , and nocturnal diastolic BP ( DBP ) . Conclusion : It does not appear useful to advise patients with long-st and ing hypertension to modify timing of aspirin intake in order to reduce BP values"
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INTRODUCTION In recent years , several non-specialist mediated interventions have been developed and tested to address problematic symptoms associated with autism . These can be implemented with a fraction of cost required for specialist delivered interventions . This review represents a robust evidence of clinical effectiveness of these interventions in improving the social , motor and communication deficits among children with autism . METHODS An electronic search was conducted in eight academic data bases from their inception to 31st December 2018 . A total of 31 r and omized controlled trials were published post-2010 while only 2 were published prior to it . Outcomes pertaining to communication , social skills and caregiver-child relationship were meta-analyzed when reported in > 2 studies . RESULTS A significant improvement was noted in child distress ( SMD = 0.55 ) , communication ( SMD = 0.23 ) , expressive language ( SMD = 0.47 ) , joint engagement ( SMD = 0.63 ) , motor skills ( SMD = 0.25 ) , parental distress ( SMD = 0.33 ) parental self-efficacy ( SMD = 0.42 ) parent-child relationship ( SMD = 0.67 ) repetitive behaviors ( SMD = 0.33 ) , self-regulation ( SMD = 0.54 ) , social skills ( SMD = 0.53 ) symptom severity ( SMD = 0.44 ) and visual reception ( SMD = 0.29 ) . CONCLUSION Non-specialist mediated interventions for autism spectrum disorder demonstrate effectiveness across a range of outcomes for children with autism and their caregivers
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"OBJECTIVE This study reports 12-month follow-up data from a r and omized controlled trial of preschool-based social communication treatment for young children with autism . METHOD A total of 61 children ( 48 males ) with autism , 29 to 60 months of age , had earlier been r and omized either to 8 weeks of preschool-based social communication treatment in addition to st and ard preschool program ( n = 34 ) or to st and ard preschool program only ( n = 27 ) . Significant short-term effects on targeted social communication skills have previously been published . Long-term gains in social communication , language and global social functioning and communication were assessed from video-taped preschool teacher-child and mother-child interactions , Early Social Communication Scales , Reynell Developmental Language Scale , and Social Communication Question naire . RESULTS Compared with those in the control group , the treated children achieved significantly larger improvements in joint attention and joint engagement from baseline to 12-month follow-up . However , no effects were detected on language and global ratings of social functioning and communication . The treatment effect on child initiation of joint attention increased with increasing level of sociability at baseline , whereas nonverbal IQ and expressive language had no moderating effect . CONCLUSIONS This study is the first to show that , similar to specialist-delivered treatment , preschool-based treatment may produce small but possibly clinical ly important long-term changes in social communication in young children with autism . The treatment did not affect language and global ratings of social functioning and communication . More studies are needed to better underst and whether treatment effects may be improved by increasing the intensity and duration of the treatment . Clinical trial registration information -- Joint Attention Intervention and Young Children With Autism ; http:// clinical trials.gov/ ; NCT00378157",
"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",
"The current study is a r and omized clinical trial evaluating the efficacy of Focused Playtime Intervention ( FPI ) in a sample of 70 children with Autism Spectrum Disorder . This parent-mediated intervention has previously been shown to significantly increase responsive parental communication ( Siller et al. in J Autism Dev Disord 43:540–555 , 2013a ) . The current analyses focus on children ’s attachment related outcomes . Results revealed that children who were r and omly assigned to FPI showed bigger increases in attachment-related behaviors , compared to children assigned to the control condition . Significant treatment effects of FPI were found for both an observational measure of attachment-related behaviors elicited during a brief separation-reunion episode and a question naire measure evaluating parental perceptions of child attachment . The theoretical and clinical implication s of these findings are discussed",
"Adolescents with ASD face numerous personal and context ual barriers that impede the development of social motivation and core competencies , warranting the need for targeted intervention . A r and omized controlled trial was conducted with 40 adolescents to evaluate the merits of a multi-component socialization intervention that places emphasis on experiential learning . This investigation evaluated the impact of the 20-week START program on the social functioning of adolescents with ASD . Significant Group × Time differences between START and waitlist control groups were found across multiple measures . Secondary analyses of the entire program cohort also yielded significant improvement trends across all measures . These findings may be an important step in identifying optimal strategies to target the complex factors limiting optimal social development in ASD",
"Increased anxiety and stress are frequently found in children with autism spectrum disorder and are associated with social challenges . Recently , we reported changes in social competence following peer-mediated , theatre-based intervention . The purpose of this study was to examine the impact of the intervention on reducing anxiety and stress . Participants included 30 youth with autism spectrum disorder ( 8–14 years old ) r and omly assigned to the experimental ( 17 ) or waitlist control ( 13 ) group . Pretest adjusted , between-group differences were analyzed for state-anxiety , trait-anxiety , play-based cortisol , and diurnal cortisol . Pearson correlations were conducted between anxiety , cortisol , and group play . Significant pretest-adjusted between-group differences at posttest were observed on trait-anxiety ( F(1 , 27 ) = 9.16 , p = 0.005 ) but not state-anxiety ( F(1 , 27 ) = 0.03 , p = 0.86 ) , showing lower trait-anxiety in the experimental group . There were no between-group differences on cortisol . There was a significant negative correlation between group play and trait-anxiety ( r = −0.362 , p = 0.05 ) . Playground cortisol correlated with group play , for the experimental group ( r = 0.55 , p = 0.03 ) . The theatre-based , peer-mediated intervention not only contributes to improvement in social competence in youth with autism spectrum disorder but also contributes to reductions in trait-anxiety associated with more social interaction with peers . Results suggest that some degree of physiological arousal is essential for social interaction",
"The efficacy of a peer-mediated , theatre-based intervention on social competence in participants with autism spectrum disorder ( ASD ) was tested . Thirty 8-to-14 year-olds with ASD were r and omly assigned to the treatment ( n = 17 ) or a wait-list control ( n = 13 ) group . Immediately after treatment , group effects were seen on social ability , ( d = .77 ) , communication symptoms ( d = −.86 ) , group play with toys in the company of peers ( d = .77 ) , immediate memory of faces as measured by neuropsychological ( d = .75 ) and ERP methods ( d = .93 ) , delayed memory for faces ( d = .98 ) , and theory of mind ( d = .99 ) . At the 2 month follow-up period , group effects were detected on communication symptoms ( d = .82 ) . The results of this pilot clinical trial provide initial support for the efficacy of the theatre-based intervention",
"This study compared immediate and 4-month outcomes among adolescents with autism spectrum disorder r and omly assigned to the PEERS curriculum ( n = 10 ) , a peer mediated PEERS curriculum ( n = 12 ) , or a delayed treatment control group ( n = 12 ) . Findings suggest a modest advantage in social skills knowledge and social functioning for participants in the peer-mediated PEERS curriculum relative to Traditional PEERS , and gains in social skills knowledge , social functioning , and reductions in loneliness were maintained in one or both treatment groups at a 4-month follow-up . Typically developing peer mentors ( n = 16 ) showed improvements in social skills knowledge and marginal improvements in autism knowledge and loneliness . Future research with a larger sample and objective outcome measures is needed",
"Children with Autism Spectrum Disorder ( ASD ) often experience difficulty participating in everyday home routines , such as bed time or bath time . This r and omized controlled trial examined the efficacy of an interactive , web‐based parenting tutorial for improving children 's engagement in daily routines ( i.e. , proximal outcomes ) as well improving children 's social communication and parenting efficacy and stress ( i.e. , broad outcomes ) . Parents of children with ASD between 18 and 60 months were r and omly assigned to the Tutorial group ( n = 52 ) or the Control group ( n = 52 ) . All parents completed question naires at baseline ( T1 ) , 1 month after T1 ( T2 ; post‐tutorial completion ) , and 2 months after T1 ( T3 ) . Relative to the Control group , parents in the Tutorial group reported significantly higher use of evidence ‐based instructional strategies and higher levels of child engagement during routines at T2 and T3 . In addition , parents in the Tutorial group reported significantly lower parenting stress and higher parenting efficacy at T3 , as well as higher ratings of child social communication at T2 and T3 , compared to the Control group . Parents reported being highly satisfied with both the clinical content and technical aspects of the tutorial . These improvements in both proximal and broad parent‐child outcomes suggest that this tutorial may be a promising and accessible way for empowering some parents and improving parent‐child interactions . Autism Res 2018 , 11 : 667–678 . © 2018 International Society for Autism Research , Wiley Periodicals ,",
"OBJECTIVE To determine the effect of the Early Start Denver Model ( ESDM ) for treatment of young children with autism on health care service use and costs . METHOD We used data from a r and omized trial that tested the efficacy of the ESDM , which is based on developmental and applied behavioral analytic principles and delivered by trained therapists and parents , for 2 years . Parents were interviewed about their children 's service use every 6 months from the onset of the intervention to follow-up ( age 6 years ) . The sample for this study consisted of 39 children with autism who participated in the original r and omized trial at age 18 to 30 months , and were also assessed at age 6 years . Of this sample , 21 children were in the ESDM group , and 18 children were in the community care ( COM ) group . Reported services were categorized and costed by applying unit hourly costs . Annualized service use and costs during the intervention and post intervention for the two study arms were compared . RESULTS During the intervention , children who received the ESDM had average annualized total health-related costs that were higher by about $ 14,000 than those of children who received community-based treatment . The higher cost of ESDM was partially offset during the intervention period because children in the ESDM group used less applied behavior analysis (ABA)/early intensive behavioral intervention ( EIBI ) and speech therapy services than children in the comparison group . In the postintervention period , compared with children who had earlier received treatment as usual in community setting s , children in the ESDM group used less ABA/EIBI , occupational/physical therapy , and speech therapy services , result ing in significant cost savings in the amount of about $ 19,000 per year per child . CONCLUSION Costs associated with ESDM treatment were fully offset within a few years after the intervention because of reductions in other service use and associated costs . CLINICAL TRIAL REGISTRATION INFORMATION Early Characteristics of Autism ; http:// clinical trials.gov/ ; NCT0009415",
"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",
"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",
"BACKGROUND Peer mediated intervention ( PMI ) is a promising practice used to increase social skills in children with autism spectrum disorder ( ASD ) . PMIs engage typically developing peers as social models to improve social initiations , responses , and interactions . METHOD The current study is a systematic review examining PMIs for children and adolescents with ASD conducted using group design s. Five studies met the pre-specified review inclusion criteria : four r and omized controlled trials and one pre- and post-test design . RESULTS Four of the studies were conducted in school setting s , whereas one study was conducted in a camp setting . The studies all reported that participants improved in social skills ( e.g. , social initiations , social responses , social communication ) post intervention . Additionally , sustainment , generalization , and fidelity of implementation were examined . CONCLUSION PMI is a promising approach to address social skills in children with ASD , and this approach can be conducted in meaningful real-word context s , such as schools . Limitations of the studies as well as future directions are discussed",
"BACKGROUND This r and omized controlled trial compared Hanen 's ' More than Words ' ( HMTW ) , a parent-implemented intervention , to a ' business as usual ' control group . METHODS Sixty-two children ( 51 boys and 11 girls ; M age = 20 months ; SD = 2.6 ) who met criteria for autism spectrum disorders ( ASD ) and their parents participated in the study . The HMTW intervention was provided over 3.5 months . There were three measurement periods : prior to r and omization ( Time 1 ) and at 5 and 9 months post enrollment ( Times 2 and 3 ) . Children 's communication and parental responsivity were measured at each time point . Children 's object interest , a putative moderator , was measured at Time 1 . RESULTS There were no main effects of the HMTW intervention on either parental responsivity or children 's communication . However , the effects on residualized gains in parental responsivity from Time 1 to both Times 2 and 3 yielded noteworthy effect sizes ( Glass 's Δ = .71 , .50 respectively ) . In contrast , there were treatment effects on child communication gains to Time 3 that were moderated by children 's Time 1 object interest . Children with lower levels of Time 1 object interest exhibited facilitated growth in communication ; children with higher levels of object interest exhibited growth attenuation . CONCLUSIONS The HMTW intervention showed differential effects on child communication depending on a baseline child factor . HMTW facilitated communication in children with lower levels of Time 1 object interest . Parents of children who evidence higher object interest may require greater support to implement the HMTW strategies , or may require different strategies than those provided by the HMTW curriculum",
"BACKGROUND Autism spectrum disorder affects more than 5 million children in south Asia . Although early interventions have been used for the treatment of children in high-income countries , no substantive trials have been done of the interventions adapted for use in low-income and middle-income countries ( LMICs ) . We therefore assessed the feasibility and acceptability of the parent-mediated intervention for autism spectrum disorder in south Asia ( PASS ) in India and Pakistan . METHODS A single-blind r and omised trial of the comparison of 12 sessions of PASS ( plus treatment as usual ) with treatment as usual alone delivered by non-specialist health workers was done at two centres in Goa , India , and Rawalpindi , Pakistan . Children aged 2 - 9 years with autism spectrum disorder were r and omly assigned ( 1:1 ) by use of probabilistic minimisation , controlling for treatment centre ( Goa or Rawalpindi ) , age ( . The primary outcome was quality of parent-child interaction on the Dyadic Communication Measure for Autism at 8 months . Analysis was by intention to treat . The study is registered with IS RCT N , number IS RCT N79675498 . FINDINGS From Jan 1 to July 30 , 2013 , 65 children were r and omly allocated , 32 to the PASS group ( 15 in Goa and 17 in Rawalpindi ) and 33 to the treatment-as-usual group ( 15 in Goa and 18 in Rawalpindi ) . 26 ( 81 % ) of 32 participants completed the intervention . After adjustment for minimisation factors and baseline outcome , the primary outcome showed a treatment effect in favour of PASS in parental synchrony ( adjusted mean difference 0·25 [ 95 % CI 0·14 to 0·36 ] ; effect size 1·61 [ 95 % CI 0·90 to 2·32 ] ) and initiation of communication by the child with the parent ( 0·15 [ 0·04 to 0·26 ] ; effect size 0·99 [ 0·29 to 1·68 ] ) , but time in mutual shared attention was reduced ( -0·16 [ -0·26 to -0·05 ] ; effect size -0·70 [ -1·16 to -0·23 ] ) . INTERPRETATION Our results show the feasibility of adapting and task-shifting an intervention used in a high-income context to LMICs . The findings also replicate the positive primary outcome treatment effects of a parent-mediated communication-focused intervention in the original UK Preschool Autism Communication Trial , with one negative effect not reported previously . FUNDING Autism Speaks , USA",
"Tactile abnormalities are severe and universal in preschool children with autism . They respond well to treatment with a daily massage protocol directed at tactile abnormalities ( QST massage for autism ) . Treatment is based on a model for autism proposing that tactile impairment poses a barrier to development . Two previous r and omized controlled trials evaluating five months of massage treatment reported improvement of behavior , social/communication skills , and tactile and other sensory symptoms . This is the first report from a two-year replication study evaluating the protocol in 103 preschool children with autism . Parents gave daily treatment ; trained staff gave weekly treatment and parent support . Five-month outcomes replicated earlier studies and showed normalization of receptive language ( 18 % , P = .03 ) , autistic behavior ( 32 % , P = .006 ) , total sensory abnormalities ( 38 % , P = .0000005 ) , tactile abnormalities ( 49 % , P = .0002 ) , and decreased autism severity ( medium to large effect size , P = .008 ) . In addition , parents reported improved child-to-parent interactions , bonding , and decreased parenting stress ( 44 % , P = .00008 ) . Early childhood special education programs are tasked with addressing sensory abnormalities and engaging parents in effective home programs . Until now , they have lacked research -based methods to do so . This program fulfills the need . It is recommended to parents and ECSE programs ( ages 3–5 ) at autism diagnosis",
"The purpose of this r and omized control group study was to examine the effects of a peer network intervention that included peer mediation and direct instruction for Kindergarten and First- grade children with autism spectrum disorders . Trained school staff members provided direct instruction for 56 children in the intervention group , and 39 children participated in a comparison group . Results showed children in the intervention group displayed significantly more initiations to peers than did the comparison group during non-treatment social probes and generalization probes . Treatment session data showed significant growth for total communications over baseline levels . Children in treatment also showed more growth in language and adaptive communication . Finally , teachers ’ ratings of prosocial skills revealed significantly greater improvements for the intervention group",
"& NA ; This study reports on the results of a r and omized controlled trial that evaluated a caregiverbased intervention program for children with autism in community day‐care centers . Thirty‐five preschool children with a DSM III‐R diagnosis of autism or pervasive developmental disorder were r and omized to an experimental or control group . Children in the experimental group were enrolled in day care and their parents and child care workers received a 12‐week intervention consisting of lectures and on‐site consultations to day‐care centers . In addition , supportive work was undertaken with families . Control subjects received day care alone . In the experimental group , there were greater gains in language abilities , significant increases in caregivers ' knowledge about autism , greater perception of control on the part of mothers , and greater parent satisfaction . We conclude that this research design demonstrated that the intervention was significantly superior to day care alone",
"To evaluate the efficacy of the Social ABCs parent‐mediated intervention for toddlers with suspected or confirmed autism spectrum disorder ( ASD ) , through a cross‐site r and omized control trial , sixty‐three parent – toddler dyads ( toddler age : 16–30 months ) were r and omized into treatment ( Social ABCs ) or control ( service‐as‐usual ) conditions . Video data were obtained at three key time‐points : Baseline ; Post‐training ( PT ; week 12 ) ; and Follow‐Up ( week 24 ) . Analyses included 62 dyads . Treatment allocation significantly accounted for PT gains , all favouring the Treatment group , in ( 1 ) child functional vocal responsiveness to parent prompts ( R2 = 0.43 , P .001 ) , ( 2 ) child vocal initiations ( R2 = 0.28 , P .001 ) , ( 3 ) parent smiling ( R2 = 0.09 , P = .017 ) , and ( 4 ) fidelity of implementation ( R2 = 0.71 , P observed for increased social orienting ( R2 = 0.06 , P = 0.054 ) ; gains in parent smiling significantly predicted increases in child smiling and social orienting . Parents in the treatment condition reported significant gains in self‐efficacy following the intervention ( P = 0.009 ) . No differential effects emerged for performance on st and ardized measures . The Social ABCs is a relatively low‐re source , efficacious intervention , with potential to be a cost‐effective means of intervening at the first signs of possible ASD . Autism Res 2017 , 10 : 1700–1711 . © 2017 International Society for Autism Research , Wiley Periodicals ,",
"This pilot RCT compared the effect of a self-directed and therapist-assisted telehealth-based parent-mediated intervention for young children with ASD . Families were r and omly assigned to a self-directed or therapist-assisted program . Parents in both groups improved their intervention fidelity , self-efficacy , stress , and positive perceptions of their child ; however , the therapist-assisted group had greater gains in parent fidelity and positive perceptions of child . Children in both groups improved on language measures , with a trend towards greater gains during a parent – child interaction for the therapist-assisted group . Only the children in the therapist-assisted group improved in social skills . Both models show promise for delivering parent-mediated intervention ; however , therapist assistance provided an added benefit for some outcomes . A full-scale comparative efficacy trial is warranted",
"A recent r and omized controlled trial ( RCT ) of a dual parent and trainer-delivered qigong massage intervention for young children with autism result ed in improvement of measures of autism as well as improvement of abnormal sensory responses and self-regulation . The RCT evaluated the effects of the parent-delivered component of the intervention . Forty-seven children were r and omly assigned to treatment and wait-list control groups . Treatment group children received the parent-delivered program for 4 mo . Trained therapists provided parent training and support . Improvement was evaluated in two setting s -- preschool and home -- by teachers ( blind to group ) and parents . Results showed that the parent-delivered program was effective in improving measures of autism ( medium effect size ) and sensory and self-regulatory responses ( large effect size ) . Teacher data on measures of autism were confirmed by parent data . Results indicate that the parent-delivered component of the program provided effective early intervention for autism that was suitable for delivery at home",
"Enhancing immediate and contingent responding by caregivers to children ’s signals is an important strategy to support social interactions between caregivers and their children with autism . Yet , there has been limited examination of parents ’ responsive behaviour in association with children ’s social behaviour post caregiver-mediated intervention . Eighty-five dyads were r and omized to one of two 10-week caregiver-training interventions . Parent – child play interactions were coded for parental responsivity and children ’s joint engagement . Significant gains in responsivity and time jointly engaged were found post JASPER parent-mediated intervention over a psychoeducation intervention . Further , combining higher levels of responsive behaviour with greater adoption of intervention strategies was associated with greater time jointly engaged . Findings encourage a focus on enhancing responsive behaviour in parent-mediated intervention models",
"This study investigated whether or not children with autism or a related pervasive developmental disorder ( PDD ) can benefit from regular opportunities to interact with a normally developing peer , matched as to sex and age . An experimental design with r and om assignment of subjects to treatment and control groups was used to demonstrate the impact of this peer-mediated intervention . In the treatment group , we found significant improvements in the social behavior of the children with PDD . Several gains were also generalized to interactions with an unfamiliar nonh and icapped peer , to interactions with another child with PDD , and to the large school setting . In the untreated control group , no positive changes were observed . Results suggest that children with PDD can develop peer relations if appropriate social context s are made available for them",
"Objective : This cluster r and omized trial ( CRT ) evaluated the efficacy of the Classroom Social , Communication , Emotional Regulation , and Transactional Support ( SCERTS ) Intervention ( CSI ) compared with usual school-based education with autism training modules ( ATM ) . Method : Sixty schools with 197 students with autism spectrum disorder ( ASD ) in 129 classrooms were r and omly assigned to CSI or ATM . Mean student age was 6.79 years ( SD 1.05 ) and 81.2 % were male . CSI teachers were trained on the model and provided coaching throughout the school year to assist with implementation . A CRT , with students nested within general and special education classrooms nested within schools , was used to evaluate student outcomes . Results : The CSI group showed significantly better outcomes than the ATM group on observed measures of classroom active engagement with respect to social interaction . The CSI group also had significantly better outcomes on measures of adaptive communication , social skills , and executive functioning with Cohen ’s d effect sizes ranging from 0.31 to 0.45 . Conclusion : These findings support the preliminary efficacy of CSI , a classroom-based , teacher-implemented intervention for improving active engagement , adaptive communication , social skills , executive functioning , and problem behavior within a heterogeneous sample of students with ASD . This makes a significant contribution to the literature by demonstrating efficacy of a classroom-based teacher-implemented intervention with a heterogeneous group of students with ASD using both observed and reported measures",
"The treatment gap for autism globally is high . Our previous PASS intervention , delivered by community based lay health workers , showed effectiveness . This article reports the development and evaluation of a new “ PASS ‘ Plus ’ ” intervention in a rural population in India . Using formative research methods , we supplemented the PASS intervention with additional ( Plus ) modules to address autism comorbidities . This is the first time that a rigorous methodology has been used to evaluate autism symptom outcomes in a low and middle‐income country setting . 40 parent – child dyads were recruited in a pilot r and omized controlled trial against usual care ( mean age 65 months ( 34 boys ) ; n = 19 PASS Plus , n = 21 UC ) . 89 % of intervention families partially or entirely completed the 12‐session intervention . Intention to treat analysis showed a reduction in mean scores of autism symptom severity , though the confidence interval contains zero , ( adjusted mean difference AMD −2.42 95 % CI −7.75 , 2.92 ; ES 0.22 ) ; large treatment effects on proximal outcomes of proportion of parent synchronous responses ( AMD 0.35 ; 95 % CI 0.18 , 0.52 ; effect size ES 3.97 ) and proportion of child communication initiations with parent ( AMD 0·17 ; 95 % CI 0.03 , 0.32 ; ES 1.02 ) . Confidence intervals for effects on mutual shared attention ( AMD 0.10 ; 95 % CI −0.07 , 0.27 ; ES 0.5 ) and co‐morbid symptoms ( AMD −9.0 ; 95 % CI −24.26 , 6.26 ; ES 0.32 ) contained zero . There were significant effects to improve parental mental health . PASS Plus shows good feasibility and adds to the evidence of the effectiveness of task sharing complex autism interventions to lay health workers in India . Autism Res 2019 , 12 : 328–339 © 2018 International Society for Autism Research , Wiley Periodicals ,",
"This exploratory r and omised controlled trial tested the effectiveness of a tablet-based information communication technology early intervention application to augment existing therapy with the aim of improving visual motor , imitation , language and social skills in young children with ASD who reside in regional areas . Fifty-nine participants were recruited and r and omised to either a therapy-as-usual group or intervention group . With the exception of the expressive language subscale on the Mullen Scales of Early Learning , no significant between-group differences were recorded for visual motor , imitation , receptive language and social skills of participants between baseline and post-intervention . When all participants were pooled and measured over time , improvements were shown in receptive and pragmatic language and social skills ; these gains were maintained , thus suggesting skill acquisition",
"There has been a significant increase in the development of interventions to improve the social competence and success of adolescents with autism spectrum disorder . The current investigation used direct observation and coding of social conversations as a rigorous method to further assess the efficacy of the Social Tools And Rules for Teens socialization intervention for adolescents with autism spectrum disorder in the context of a r and omized controlled trial . A total of 35 adolescents with high-functioning autism spectrum disorder were r and omized to either a treatment or waitlist control group . The 20-week group intervention took place once a week for 90 min per session . Brief video-recorded conversations between participants and unfamiliar , untrained peers were recorded at pre- and post-time points and coded for selected social behaviors ( i.e. questions asked , positive facial expressions , and mutual engagement ) . Results revealed a significant Group × Time treatment effect for both questions asked and positive facial expressions . The findings support that the Social Tools And Rules for Teens intervention can positively impact specific , observable social behaviors through systematic coding of live social conversations within the context of a r and omized controlled trial . This investigation is one of the first r and omized controlled trials of a group socialization intervention to use systematic coding of live social conversations to assess social competence improvements",
"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",
"Early intervention for autism spectrum disorder ( ASD ) tends to focus on enhancing social-communication skills . We report the acceptability , feasibility and impact on child functioning of a new 8 weeks parent-group intervention to manage restricted and repetitive behaviours ( RRB ) in young children with ASD aged 3–7 years . Forty-five families took part in the pilot RCT . A range of primary and secondary outcome measures were collected on four occasions ( baseline , 10 , 18 and 24 weeks ) to capture both independent ratings and parent-reported changes in RRB . This pilot established that parents were willing to be recruited and r and omised , and the format and content of the intervention was feasible . Fidelity of delivery was high , and attendance was 90 % . A fully powered trial is now planned",
"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"
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BACKGROUND : The value of adding testosterone to hormone therapy ( HT ) for the management of peri- and postmenopausal women is controversial and has not been systematic ally review ed . OBJECTIVES : To determine the benefits and risks of testosterone therapy for peri- and postmenopausal women taking hormone therapy . SEARCH STRATEGY : We search ed the Cochrane Menstrual Disorders and Subfertility Group Trials Register ( 1st November 2003 ) , The Cochrane Library ( Issue 2 , 2003 ) , MEDLINE ( 1966 to 1st November 2003 ) , EMBASE ( 1980 to 1st November 2003 ) , Biological Abstract s ( 1969 to 2002 ) , PsycINFO ( 1972 to 1st November 2003 ) , CINAHL ( 1982 to 1st November 2003 ) , and reference lists of articles . We also contacted pharmaceutical companies and research ers in the field . SELECTION CRITERIA : Studies that were r and omized comparisons of testosterone plus hormone therapy versus hormone therapy alone in peri- or postmenopausal women . DATA COLLECTION AND ANALYSIS : Two review authors assessed the quality of the trials and extracted data independently . Where it was necessary , the corresponding authors of eligible trials were contacted for additional information . For dichotomous outcomes Peto odds ratios and 95 % confidence intervals were calculated . For continuous outcomes non-skewed data from valid scales were synthesized using a weighted mean difference or st and ardized mean difference . If statistical heterogeneity was found , a r and om-effects model was used and reasons for the heterogeneity were explored and discussed . MAIN RESULTS : Twenty-three trials with 1957 participants were included in the review . The median study duration was 6 months ( range 1.5 to 24 months ) . Most of the trials were of adequate quality with regard to r and omization and concealment of allocation sequence . The major method ological limitations were attrition bias and lack of a washout period in the cross-over studies . The pooled estimate from the studies suggested that the addition of testosterone to HT regimens improved sexual function scores for postmenopausal women . A significant adverse effect was a decrease in high-density lipoprotein ( HDL ) cholesterol levels . The discontinuation rate was not significantly greater with testosterone therapy ( Peto odds ratio 1.01 , 95 % confidence interval 0.76 to 1.33 ) than with HT alone . There was insufficient evidence of a treatment effect for perimenopausal women or for other outcomes . AUTHORS ' CONCLUSIONS : Only a limited number of studies could be pooled in the meta-analyses . This limited the power of the meta- analysis to provide conclusions about efficacy and safety . However , there is evidence that adding testosterone to HT has a beneficial effect on sexual function in postmenopausal women . There was a reduction in HDL cholesterol associated with the addition of testosterone to the HT regimens . The meta- analysis combined studies using different testosterone regimens . It is , therefore , difficult to estimate the effect of testosterone on sexual function in association with any individual hormone treatment regimen
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"Our most striking finding was that of the 16 patients monitored by the technique , those with no spontaneous lower oesophageal contractility at any time , but with provoked activity intact , were invariably subsequently diagnosed as brain dead clinical ly after the action ofpancuronium had worn off or been reversed . In this institution brain death is diagnosed using the criteria set out by the royal colleges and faculties of the United Kingdom.3 In addition , carotid arteriography is performed to show cessation ofcerebral circulation . The loss of spontaneous contractility in the presence of continuing provoked activity is explained by the normal physiology of the human oesophagus . The principal nerve supply is derived from the vagus nerve . The lower oesophageal muscle is supplied from intramural and paraoesophageal nerve plexuses . Vagal afferent and efferent fibres connect the oesophageal plexuses with the brain stem nuclei of the vagus nerve , which in turn are connected with higher cortical centres . The mechanisms governing production of non-propulsive activity are unknown , though acoustic stimuli as well as other forms of external stimuli can provoke this response.45 Thus it appears that an intact pathway between the brain and oesophagus is required for non-propulsive activity to occur . By contrast , secondary activity ( peristaltic ) has been recorded in the isolated opossum oesophagus ex vivo and so does not require control by higher centres.2 Hence in brain dead patients spontaneous lower oesophageal contractility would not be expected , whereas provokedcontractility should be intact , as we have found . We conclude that monitoring lower oesphageal contractility may be very useful in the early identification of brain death and may help to predict outcome in patients with head injury",
"Objectives : To investigate the cognitive effects of high-dose oral estrogen alone or in combination with oral methyltestosterone in postmenopausal women . Methods : Participants were tested with a r and omized , double-blind design on the Identical Pictures , Cube Comparisons , Building Memory and Shape Memory tasks before and after 4 months of hormone treatment . Results : Women receiving estrogen and methyltestosterone maintained a steady level of performance on the Building Memory task , whereas those receiving estrogen alone showed a decrease in performance . Conclusions : These results indicate that the addition of testosterone to high-dose estrogen replacement exerts a protective effect on memory performance in postmenopausal women",
"CONTEXT Hypoactive sexual desire disorder ( HSDD ) is one of the most common sexual problems reported by women , but few studies have been conducted to evaluate treatments for this condition . OBJECTIVE The objective of this study was to evaluate the efficacy and safety of a testosterone patch in surgically menopausal women with HSDD . DESIGN The design was a r and omized , double-blind , parallel-group , placebo-controlled , 24-wk study ( the Intimate SM 1 study ) . SETTING The study was performed at private or institutional practice s. PATIENTS The subjects studied were women , aged 26 - 70 yr , with HSDD after bilateral salpingo-oophorectomy who were receiving concomitant estrogen therapy . Placebo ( n = 279 ) or testosterone 300 microg/d ( n = 283 ) was administered . There were 19 patients who withdrew due to adverse events in the placebo group and 24 in the 300 mug/d testosterone group . INTERVENTION Testosterone ( 300 microg/d ) or placebo patches were applied twice weekly . MAIN OUTCOME MEASURE(S ) The primary end point was the change in the frequency of total satisfying sexual activity at 24 wk . Secondary end points included other sexual functioning end points and safety assessment s. RESULTS At 24 wk , there was an increase from baseline in the frequency of total satisfying sexual activity of 2.10 episodes/4 wk in the testosterone group , which was significantly greater than the change of 0.98 episodes/4 wk in the placebo group ( P = 0.0003 ) . The testosterone group also experienced statistically significant improvements in sexual desire and a decrease in distress . The overall safety profile was similar in both treatment groups . CONCLUSION In the Intimate SM 1 study , the testosterone patch improved sexual function and decreased distress in surgically menopausal women with HSDD and was well tolerated in this trial",
"Objective To compare an oral estrogen- and rogen combination with estrogens alone on bone , menopausal symptoms , and lipoprotein profiles in postmenopausal women . Methods Surgically menopausal women received oral esterified estrogens ( 1.25 mg ) , or esterified estrogens ( 1.25 mg ) and methyltestosterone ( 2.5 mg ) daily , for 2 years . Bone mineral density of the lumbar spine and hip , menopausal symptoms , lipoprotein profiles , and biochemical and hematologic indices were evaluated . Results Sixty-six patients were enrolled in the study . Both treatment regimens prevented bone loss at the spine and hip ; combined estrogen- and rogen therapy was associated with a significant increase in spinal bone mineral density compared with baseline ( n = 24 ; mean score ± st and ard error 3.4 ± 1.2 % , P group , high-density lipoprotein ( HDL ) cholesterol increased significantly and low-density lipoprotein cholesterol decreased significantly . Cholesterol , HDL cholesterol , and triglycerides decreased significantly in the estrogen- and rogen group . Menopausal symptoms of somatic origin ( hot flashes , vaginal dryness , and insomnia ) were improved significantly by both treatments . Neither adverse hepatic effects nor significant safety or tolerance problems were reported in either group . Conclusion Oral estrogen- and rogen increased vertebral bone mineral density compared with pre-treatment values and relieved somatic symptoms . Safety indices , including lipoprotein levels , indicated that the combination was well tolerated over the 2 years of treatment",
"CONTEXT Changes in and rogen levels across the adult female life span and the effects of natural menopause and oophorectomy have not been clearly established . OBJECTIVE The objective of this study was to document the effects of age on and rogen levels in healthy women and to explore the effects of natural and surgical menopause . DESIGN , SETTING , AND PARTICIPANTS A cross-sectional study was conducted of 1423 non-healthcare-seeking women , aged 18 - 75 yr , r and omly recruited from the community over 15 months . MAIN OUTCOME MEASURES Serum levels by age of total testosterone ( T ) , calculated free T , dehydroepi and rosterone sulfate , and and rostenedione in a reference group of women free of confounding factors . Women in the reference group had no usage of exogenous steroid therapy ; no history of tubal ligation , hysterectomy , or bilateral oophorectomy ; and no hyperprolactinemia or polycystic ovarian syndrome . The effects of natural and surgical menopause on sex steroid levels were also examined . RESULTS In the reference population ( n = 595 ) , total T , calculated free T , dehydroepi and rosterone sulfate , and and rostenedione declined steeply with age ( P serum and rogen levels by year in women aged 45 - 54 yr showed no independent effect of menopausal status on and rogen levels . In women aged 55 yr or older , those who reported bilateral oophorectomy and were not on exogenous steroids had significantly lower total T and free T levels than women 55 yr or older in the reference group . CONCLUSIONS We report that serum and rogen levels decline steeply in the early reproductive years and do not vary because a consequence of natural menopause and that the postmenopausal ovary appears to be an ongoing site of testosterone production . These significant variations in and rogens with age must be taken into account when normal ranges are reported and in studies of the role of and rogens in women",
"OBJECTIVE In some women , a decline in sexual interest accompanies a relative and rogen insufficiency after menopause . We sought to characterize the hormonal effects of the combination of oral esterified estrogens and methyltestosterone and to investigate whether this regimen improves hypoactive sexual desire . DESIGN Double-blind r and omized trial . SETTING Healthy volunteers in a multicenter research environment . PATIENT(S ) Postmenopausal women taking estrogen therapy who were experiencing hypoactive sexual desire . INTERVENTION(S ) 4 months of treatment with 0.625 mg of esterified estrogens ( n = 111 ) or the combination of 0.625 mg of esterified estrogens and 1.25 mg of methyltestosterone ( n = 107 ) . MAIN OUTCOME MEASURES Baseline and end-of- study measurements of total and bioavailable testosterone and sex hormone-binding globulin ( SHBG ) , and mean change in level of sexual interest or desire as rated on the Sexual Interest Question naire . RESULT ( S ) Treatment with the combination of esterified estrogens and methyltestosterone significantly increased the concentration of bioavailable testosterone and suppressed SHBG . Scores measuring sexual interest or desire and frequency of desire increased from baseline with combination treatment and were significantly greater than those achieved with esterified estrogens alone . Treatment with the combination was well tolerated . CONCLUSION ( S ) Increased circulating levels of unbound testosterone and suppression of SHBG provide a plausible hormonal explanation for the significantly improved sexual functioning in women receiving the combination of esterified estrogen and methyltestosterone",
"OBJECTIVE To investigate the efficacy of esterified estrogens alone and combined with oral and rogen on sexual function and menopausal symptoms in postmenopausal women . STUDY DESIGN Twenty postmenopausal women dissatisfied with their estrogen or estrogen-progestin therapy volunteered to enter a double-blind , r and omized trial in which they received either oral esterified estrogens or esterified estrogens + and rogen for eight weeks after a single-blind , placebo , lead-in period . Sexual function was assessed with a question naire used in the Yale midlife survey , and plasma levels of estradiol , estrone , sex hormone binding globulin ( SHBG ) and beta-endorphin were measured at two- to four-week intervals . RESULTS Estrogen- and rogen therapy significantly improved sexual sensation and desire after four and eight weeks of double-blind treatment in comparison to previous estrogen therapy and postplacebo baseline assessment s. Plasma levels of estradiol and estrone increased significantly in all patients as compared to the postplacebo baseline and decreased in comparison to circulating estrogen concentrations on previous therapy . Relative proportions of free and bound steroid hormone exhibited contrasting shifts during estrogen and estrogen- and rogen therapy . SHBG increased in the estrogen group and decreased in the estrogen- and rogen group , leading to lower amounts of free and rogens during estrogen therapy and increased free and rogen levels during estrogen- and rogen therapy . Since proportions of free ( bioavailable ) ovarian steroids would correlate inversely with plasma protein binding capacity , the beneficial effects of oral estrogen- and rogen therapy on sexual sensation and desire may be due either to the administered and rogen or to the increased availability of endogenous and exogenous and rogens , particularly in the central nervous system . CONCLUSION Sexual desire , satisfaction and frequency in postmenopausal women taking hormonal therapy were improved significantly by combined estrogen- and rogen therapy but not by estrogen or estrogen-progestin therapy . Sexual function improved with estrogen- and rogen therapy even though circulating estrogen levels were lower than those measured during previous estrogen therapy . This leads to the conclusion that and rogens play a pivotal role in sexual function but that estrogens are not a significant factor determining levels of sexual drive and enjoyment",
"METHODS In a r and omized , double-blind , placebo-controlled clinical trial , we evaluated the effect of a 2-year treatment with n and rolone decanoate ( ND ) on bone mineral density ( BMD ) of lumbar spine , femoral neck , and trochanter and on vertebral fracture rate , muscle mass , and hemoglobin levels . Sixty-five osteoporotic women older than 70 years were studied . Thirty-two patients received injections of 50 mg ND , and 33 received placebos every 3 weeks . All patients received 500 mg calcium tablets daily . RESULTS Compared to baseline , ND increased the BMD of the lumbar spine ( 3.4 % + /- 6.0 and 3.7 % + /- 7.4 ; p femoral neck ( 4.1 % + /- 7.3 and 4.7 % + /- 8.0 ; p BMD of trochanter increased significantly only after the first year ( 4.8 % + /- 9.3 , p BMD of the trochanter and neck . ND significantly reduced incidence of new vertebral fractures ( 21 % vs 43 % in the placebo group ; p lean body mass after the first ( 6.2 % + /- 5.8 ; p hemoglobin levels compared to baseline ( 14.3 % ; p BMD , hemoglobin levels , and muscle mass , and reduced the vertebral fracture rate of elderly osteoporotic women",
"Objective The cardioprotective effects of postmenopausal estrogen replacement therapy are mediated by several mechanisms , including favorable effects on lipids and lipoproteins . The extent to which the latter reflects modification of body fat distribution by sex steroids is not known . Hence , we investigated the relationships between changes in lipids and measures of body composition in postmenopausal women who were administered estrogen therapy with and without testosterone . Design We r and omized 33 postmenopausal women to treatment with either estradiol 50 mg ( E ) alone or estradiol 50 mg plus testosterone 50 mg implants ( E&T ) administered every 3 months for 2 years in conjunction with cyclic oral progestins for women with an intact uterus . Results Both therapies were associated with sustained reductions in total cholesterol and low-density lipoprotein ( LDL ) cholesterol . In women who received E but not E&T , hip ( p abdominal circumferences ( p fat mass : fat-free mass ( FM : FFM ) ratio over the abdomen ( p E&T but not E result ed in increased FFM ( p reduced FM : FFM ratio ( p LDL cholesterol was significantly related to changes in total and compartmental body fat and to change in the FM : FFM ratio ( p Estrogen replacement has effects on body fat distribution in postmenopausal women that are associated with improved lipid parameters . Addition of parenteral testosterone does not negate the favorable effects of estrogen on LDL cholesterol levels but may attenuate the reduction in central ized body fat achieved with E implants",
"Objective . To evaluate the effect of adding testosterone undecanoate 40 mg daily to estrogen therapy on bone markers , bone mineral density and body composition in oophorectomized women . Methods . Fifty women , 45–60 years old , who had undergone a hysterectomy and bilateral salpingo-oophorectomy for benign disorders , were r and omly assigned to oral treatment with testosterone undecanoate 40 mg plus estradiol valerate 2 mg daily or placebo plus estradiol valerate 2 mg daily . Twenty-four weeks later , cross-over was performed to the other treatment regimen . Forty-four women completed the study . Their serum concentrations of insulin-like growth factor (IGF)-I , IGF binding protein (IGFBP)-3 , osteocalcin , carboxyterminal telopeptide aminoterminal ( ICTP ) , of type I collagen propeptide of type I procollagen ( PICP ) and interleukin (IL)-1 receptor antagonist were measured at baseline and after 24 weeks of both treatments , as were also their body mass index ( BMI ) and blood pressure . Bone mineral density of the total body , spine and hip and total body fat , total lean body mass , trunk fat and trunk lean mass were determined by dual-energy X-ray absorptiometry measurements at baseline and after 24 weeks of both regimens . Results . During treatment , the addition of testosterone counteracted the decrease in IGF-I and PICP seen with estrogen therapy alone . Osteocalcin and ICTP were significantly reduced to the same extent by both therapies . No change ocurred in the IL-1 receptor antagonist . A significant increase was seen in total lean body mass with the estrogen/testosterone regimen , but the total fat mass , trunk lean or fat mass remained unchanged after 24 weeks of both treatments . No effect was detected on total , hip or spinal bone mineral density after treatment with estrogen alone or estrogen/testosterone . Likewise , BMI and blood pressure were unaffected . Conclusions . The addition of testosterone to oral estrogen might have positive effects on bone as suggested by the fact that it counteracted the decline in IGF-I and PICP levels . An anabolic effect on muscle was reflected by an increase in the total lean body mass . No adverse effects were noted on BMI , fat distribution or blood pressure during the 6-month treatment with oral testosterone undecanoate",
"OBJECTIVES This study was carried out to assess the effect of topical and rogen replacement therapy on body weight , body composition and fat distribution in postmenopausal women . METHODS 39 healthy postmenopausal women ( 51.4 + /- 2.24 years ) , with increasing body weight , were prospect ively studied for 6 months . Body composition ( fat mass , kg , % ) was measured by means of dual-energy X-ray absorptiometry ( DXA ) . Hormonal and lipid parameters were also measured . Subjects were divided into two groups . An and rogen gel ( group A ) or placebo gel ( group P ) was topically administered to the abdominal and gluteo-femoral regions . DXA was performed before commencement of topical treatment and after 6 months . RESULTS A highly significant total body weight reduction was found in group A ( 68.0 + /- 13.1 to 65.4 + /- 11.8 kg ) . Abdominal fat ( 37.3 + /- 11.2 to 35.1 + /- 9.7 % ) , gluteo-femoral fat ( 46.3 + /- 6.6 to 45.4 + /- 7.7 % ) , total body fat ( 38.2 + /- 7.9 to 36.1 + /- 8.6 % ) and BMI ( 24.8 + /- 4.3 to 23.7 + /- 3.8 ) were also found to have decreased significantly in this group . No significant reduction in body weight ( kg ) and body fat ( % ) could be measured in the placebo group . No influence on lipid parameters was found although total testosterone increased significantly in group A ( 0.29 + /- 0.24 to 0.72 + /- 0.17 ng/ml ) . CONCLUSIONS Topically applied and rogen is capable of reducing abdominal fat accumulations as well as total body weight in postmenopausal women with unexplained weight gain . In contrast to systemic and rogen application , topical administration has no effect on the lipid profile . Gluteal fat , however , is less effectively influenced by and rogens",
"BACKGROUND The ovaries provide approximately half the circulating testosterone in premenopausal women . After bilateral oophorectomy , many women report impaired sexual functioning despite estrogen replacement . We evaluated the effects of transdermal testosterone in women who had impaired sexual function after surgically induced menopause . METHODS Seventy-five women , 31 to 56 years old , who had undergone oophorectomy and hysterectomy received conjugated equine estrogens ( at least 0.625 mg per day orally ) and , in r and om order , placebo , 150 microg of testosterone , and 300 microg of testosterone per day transdermally for 12 weeks each . Outcome measures included scores on the Brief Index of Sexual Functioning for Women , the Psychological General Well-Being Index , and a sexual-function diary completed over the telephone . RESULTS The mean ( + /-SD ) serum free testosterone concentration increased from 1.2+/-0.8 pg per milliliter ( 4.2+/-2.8 pmol per liter ) during placebo treatment to 3.9+/-2.4 pg per milliliter ( 13.5+/-8.3 pmol per liter ) and 5.9+/-4.8 pg per milliliter ( 20.5+/-16.6 pmol per liter ) during treatment with 150 and 300 microg of testosterone per day , respectively ( normal range , 1.3 to 6.8 pg per milliliter [ 4.5 to 23.6 pmol per liter ] ) . Despite an appreciable placebo response , the higher testosterone dose result ed in further increases in scores for frequency of sexual activity and pleasure-orgasm in the Brief index of Sexual Functioning for Women ( P=0.03 for both comparisons with placebo ) . At the higher dose the percentages of women who had sexual fantasies , masturbated , or engaged in sexual intercourse at least once a week increased two to three times from base line . The positive-well-being , depressed-mood , and composite scores of the Psychological General Well-Being Index also improved at the higher dose ( P=0.04 , P=0.03 , and P=0.04 , respectively , for the comparison with placebo ) , but the scores on the telephone-based diary did not increase significantly . CONCLUSIONS In women who have undergone oophorectomy and hysterectomy , transdermal testosterone improves sexual function and psychological well-being",
"Objective : To evaluate the efficacy and safety of a testosterone patch for the treatment of women with hypoactive sexual desire disorder after natural menopause . Design : A multicenter , r and omized , double-blind , placebo-controlled , parallel-group trial was conducted in naturally menopausal women with hypoactive sexual desire disorder receiving a stable dose of oral estrogen with or without progestin ( N = 549 ) . Women were r and omized to receive testosterone 300 & mgr;g/day or placebo patches twice weekly for 24 weeks . The primary efficacy measure was change from baseline in frequency of total satisfying sexual activity over a 4-week period ( weeks 21 - 24 ) . Results : A total of 483 women ( 88 % ) were included in the primary analysis population ( those with baseline sex hormone binding globulin levels ≤160 nmol/L ) . The change from baseline in number of total satisfying sexual episodes was significantly greater for testosterone compared with placebo ( participants with baseline sex hormone binding globulin levels ≤160 nmol/L , mean change of 2.1 ± 0.28 versus 0.5 ± 0.23 episodes/4 weeks ; P P 0.0001 ) . Testosterone also produced statistically significant improvements compared with placebo in all secondary efficacy measures , including sexual desire and personal distress . The testosterone patch was well tolerated . Conclusions : Testosterone patch treatment increased the frequency of satisfying sexual activity and sexual desire , decreased personal distress , and was well tolerated in naturally menopausal women with hypoactive sexual desire disorder",
"And rogens are known to lower plasma triglycerides , an independent risk factor for coronary heart disease ( CHD ) . Triglycerides are carried in plasma on very low density ( VLDL ) and low density ( LDL ) lipoprotein particles . Apolipoprotein CIII ( apoCIII ) , a strong predictor of CHD , impairs the metabolism of VLDL and LDL , contributing to increased triglycerides . The objective of this study was to assess the effect of oral methyltestosterone ( 2.5 mg/d ) , added to esterified estrogens ( 1.25 mg/d ) , on concentrations of apolipoproteins and lipoproteins , specifically those containing apoCIII , compared with esterified estrogens alone in surgically postmenopausal women . The women in the methyltestosterone plus esterified estrogen group had significant decreases in total triglycerides , apoCI , apoCII , apoCIII , apoE , and high density lipoprotein ( HDL ) cholesterol compared with those in the esterified estrogen group . The decreases in apoCIII concentrations occurred in VLDL ( 62 % ; P = 0.02 ) , LDL ( 35 % ; P = 0.001 ) , and HDL ( 17 % ; P cholesterol and triglycerides concentrations of apoCIII containing LDL , and apoCI concentration of apoCIII containing VLDL . There was no effect on VLDL and LDL particles that did not contain apoCIII or on apoB concentrations . In conclusion , methyltestosterone , when administered to surgically postmenopausal women taking esterified estrogen , has a selective effect to reduce the apoCIII concentration in VLDL and LDL , a predictor of CHD . Methyltestosterone may lower plasma triglycerides through a reduction in apoCIII",
" Twenty-five women with a previous total abdominal hysterectomy with bilateral salpingo – oophorectomy ( TAH BSO ) were given estradiol 50 mg implants at baseline , followed at 16 weeks with the combination of estradiol 50 mg and testosterone 100 mg . Blood sample s were taken at 8-weekly intervals over 32 weeks . Serum levels of estradiol , testosterone , sex hormone binding globulin ( SHBG ) and agents involved in skeletal growth ( growth hormone ( GH ) , insulin-like growth factor 1 ( IGF-1 ) , carboxy terminal pro-peptide of type 1 pro-collagen ( PICP ; a bone formation marker ) and cross-linked carboxy terminal telopeptide ( ICTP ; a marker of bone resorption ) ) were measured . Serum PICP levels increased significantly after estradiol alone ( p = 0.0032 ) but the addition of testosterone had no significant effects on bone markers GH and IGF-1 . These biochemical changes confirm previous studies , which found that the addition of testosterone did not augment the effect of estradiol implants on bone mineral density . Although physiological hormone replacement therapy in oophorectomized women would include replacement of both estradiol and testosterone , this may not to be necessary for prevention of osteoporosis where adequate serum estradiol levels are reached",
"To investigate the role of and rogens in increasing bone density and improving low libido in postmenopausal women , we have studied the long-term effects of estradiol and testosterone implants on bone mineral density and sexuality in a prospect i ve , 2 year , single-blind r and omised trial . Thirty-four postmenopausal volunteers were r and omised to treatment with either estradiol implants 50 mg alone ( E ) or estradiol 50 mg plus testosterone 50 mg ( E&T ) , administered 3-monthly for 2 years . Cyclical oral progestins were taken by those women with an intact uterus . Thirty-two women completed the study . BMD ( DEXA ) of total body , lumbar vertebrae ( L1-L4 ) and hip area increased significantly in both treatment groups . BMD increased more rapidly in the testosterone treated group at all sites . A substantially greater increase in BMD occurred in the E&T group for total body ( P sexual parameters ( Sabbatsberg sexual self-rating scale ) improved significantly in both groups . Addition of testosterone result ed in a significantly greater improvement compared to E for sexual activity ( P satisfaction ( P pleasure ( P orgasm ( P relevancy ( P Total cholesterol and LDL-cholesterol fell in both groups as did total body fat . Total body fat-free mass ( DEXA , anthropometry , impedance ) increased in the E&T group only . We concluded that in postmenopausal women , treatment with combined estradiol and testosterone implants was more effective in increasing bone mineral density in the hip and lumbar spine than estradiol implants alone . Significantly greater improvement in sexuality was observed with combined therapy , verifying the therapeutic value of testosterone implants for diminished libido in postmenopausal women . The favourable estrogenic effects on lipids were preserved in women treated with T , in association with beneficial changes in body composition",
"OBJECTIVE The purpose of this study was to investigate the hormonal changes during the menopausal transition in a non- clinical population . METHODS Fifty-nine healthy Norwegian women participated in a five year prospect i ve longitudinal study during the transition from pre- to post-menopause , starting one to four years before menopause , and ending one to four years postmenopausal . None of these women were given hormone replacement therapy ( HRT ) . Blood sample s were collected every 12 months and luteinizing hormone ( LH ) , follicle stimulating hormone ( FSH ) , steroid hormone binding globuline ( SHBG ) , prolactin ( PRL ) , estradiol ( E2 ) , estrone ( E1 ) , testosterone , and rostendione , dehydroepi and rostendione-sulphate ( DHEA-S ) , and thyroid stimulating hormone ( TSH ) were analyzed . RESULTS The serum levels of FSH and LH , E2 and E1 profile essentially confirmed previous data obtained in cross-sectional studies . A continuous increase in serum FSH and LH and a concomitant fall in E2 and E1 were observed in all women before menopause and in the two postmenopausal years . Both and rostendione and testosterone showed a decline three years before menopause . After the menopause , however , there were fluctuations in the testosterone levels . And rostendione correlated positively with both E2 and E1 and testosterone postmenopausally . Body mass index ( BMI ) did correlate with testosterone , but not with and rostendione . BMI correlated negatively with SHBG . No correlation was found between BMI and E2 , E1 , FSH and LH . CONCLUSION This longitudinal prospect i ve study of hormonal changes during the transition from pre- to postmenopause indicates that not only estrogen hormonal changes , but and rogen hormonal changes as well , precedes the menopause by several years",
"Menopause is associated with decreased lean body mass and increased fat due to aging and declining hormone secretion . Estrogens or estrogen-progestins have been used to alleviate vasomotor symptoms . However , estrogen- and rogen ( E/A ) therapy is also used for vasomotor symptom relief and has been shown to increase lean body mass while decreasing fat mass . The objective of this 16-wk , double-blind , r and omized , parallel group clinical trial was to compare esterified estrogen plus methyltestosterone ( 1.25 mg estrogen + 2.5 mg methyltestosterone/d ; E/A group ) vs. esterified estrogen alone ( 1.25 mg/d ; E group ) on body composition . Forty postmenopausal women ( mean age , 57 yr ) participated . Compared with estrogen treatment alone , women in the E/A group increased their total lean body mass and reduced their percentage fat for all body parts ( P E/A treatment , there were statistically significant increases in lean body mass by 1.232 kg [ 0.181 + /- 0.004 , 0.81 + /- 0.057 , and 0.24 + /- 0.009 kg in the upper body ( P = 0.021 ) , trunk ( P = 0.001 ) , and lower body ( P = 0.047 ) , respectively ] . In the E group , the increase was 0.31 + /- 0.004 , 0.021 + /- 0.03 , and 0.056 + /- 0.05 kg in the upper body , trunk , and lower body , respectively . In the E/A group , body fat was reduced by 0.90 kg ( P = 0.18 for the trunk only ) , and percentage body fat declined by 7.4 % ( P Lower body strength increased by 23.1 kg ( 51 lb ) in the E/A group vs. only 11 kg ( 24.25 lb ) in the E group ( P = 0.002 between groups ) . A statistically significant increase in weight ( 2.7 + /- 5.1 vs. 0.1 + /- 4.6 lb ; P E/A group compared with the E group . When subjects were given self-reporting question naires , more improvement was noted in sexual functioning and quality of life in the E/A group when compared with patients receiving E alone . There were no noteworthy side effects . In conclusion , E/A replacement therapy can improve body composition , lower-body muscle strength , quality of life , and sexual functioning in postmenopausal women",
"STUDY OBJECTIVE --To compare oral and implanted oestrogens for their effects in preventing postmenopausal osteoporosis . DESIGN --Non-r and omised cohort study of postmenopausal women treated with oral or depot oestrogens and postmenopausal controls . SETTING --Gynaecological endocrine clinic in tertiary referral centre . PATIENTS --Oral treatment group of 37 postmenopausal women ( mean age 57.5 years , median 8.75 years from last menstrual period ) , compared with 41 women given oestrogen implants ( mean age 56.2 years , median 9.5 years from last menstrual period ) and 36 controls ( mean age 51.8 years , median 2.0 years from last menstrual period ) . Weight was not significantly different among the groups . INTERVENTIONS --Oral treatment group was given continuous treatment with cyclic oestrogen and progesterone preparations ( Prempak C or Cycloprogynova ) for a median of 8.0 years . Implant group was given subcutaneous implants of oestradiol 50 mg combined with testosterone 100 mg , on average six monthly for a median of 8.5 years . Controls were not treated . END POINT -- Significant increase in bone density . MEASUREMENTS AND MAIN RESULTS --Bone density measured by dual beam photon absorptiometry was 1.02 ( SD 0.13 ) g hydroxyapatite/cm2 in implant group versus 0.89 ( 0.11 ) in oral group ( p less than 0.01 ) and 0.87 ( 0.14 ) in controls ( p less than 0.01 ) . Serum oestradiol concentration in implant group was ( median ) 725 pmol/l versus 170 pmol/l in oral group ( p less than 0.01 ) and 99 pmol/l in controls ( p less than 0.01 ) . Serum follicular stimulating hormone was median 1 IU/l ( range 1 - 11 ) in implant group ( equivalent to premenopausal values ) versus 43 ( 4 - 94 ) IU/l in oral group ( p less than 0.01 ) and 72 ( 28 - 99 ) IU/l in controls ( p less than 0.01 ) . CONCLUSIONS --Subcutaneous oestrogen is more effective than oral oestrogen in preventing osteoporosis , probably owing to the more physiological ( premenopausal ) serum oestradiol concentrations achieved . It also avoids problems of compliance that occur with oral treatment",
"CONTEXT Available data concerning effects of testosterone on endometrium of postmenopausal women are seriously limited . OBJECTIVE Our aim was to compare the influence of treatment with testosterone and /or estrogen on endometrial proliferation in healthy postmenopausal women . DESIGN This was an open , r and omized clinical study with parallel comparison of the groups . SETTING The study was conducted at a women 's health clinical research unit and a research laboratory at a university hospital . PARTICIPANTS Sixty-three women who had experienced natural menopause participated in this study . INTERVENTIONS After r and om assignment , the participants were administered orally testosterone undecanoate ( 40 mg every second day ) , estradiol valerate ( 2 mg daily ) , or both for 3 months . MAIN OUTCOME MEASURES Endometrial thickness was measured , and endometrial proliferation evaluated on the basis of histopathology and expression of Ki-67 , a proliferation marker . RESULTS Endometrial thickness was significantly increased by treatment with estrogen alone or in combination with testosterone but was unaltered by testosterone alone . Among the women receiving estrogen alone , the proportion exhibiting histopathology indicative of proliferation increased significantly to 50 % ( P testosterone alone had no effect at all . Expression of Ki-67 was up-regulated significantly in both gl and s and stroma ( P expression was significantly higher in stroma by estrogen treatment alone than after combined treatment ( P testosterone of postmenopausal women does not stimulate endometrial proliferation . In addition , testosterone appears to counteract endometrial proliferation induced by estrogen to a certain extent",
"The present study examined effects of testosterone on hypoactive sexual desire in pre- and postmenopausal women ( treated ) compared with an age-matched reference group ( reference ) . Treated participants received 100 mg of testosterone cypionate in oil injected intramuscularly ( i.m . ) monthly for 3 months . We measured salivary testosterone and scores on the Sexual Desire Inventory pretreatment and posttreatment . Treated and reference participants ' baseline testosterone was equivalent , however , treated participants exhibited higher testosterone levels than did reference participants posttreatment . As expected , treated participants exhibited lower baseline sexual desire than did reference participants and showed a significant increase in sexual desire posttreatment . This research suggests that testosterone may effectively alleviate hypoactive sexual desire , even in women with normal testosterone levels ",
"OBJECTIVE To determine the effect of the and rogen supplementation of hormone replacement therapy ( HRT ) on the vascular reactivity of cerebral arteries . DESIGN Open r and omized study . SETTING Healthy volunteers in an academic research environment . PATIENT(S ) Forty postmenopausal women who were treated with sequential HRT ( transdermal E2 50 microg/d + medroxyprogesterone acetate 10 mg/d for 12 days every other month ) for > or = 1 year and INTERVENTION(S ) Testosterone undecanoate ( 40 mg/d , p.o . ) was r and omly administered to 20 patients during ongoing HRT ; the other 20 served as controls . Doppler evaluations of the internal carotid and middle cerebral arteries were performed together with lipid levels assessment s. A visual analogue scale ( VAS ) was used to evaluate various parameters relating to sexual life and well-being . MAIN OUTCOME MEASURE(S ) Pulsatility index ( PI ) of the arteries , VAS assessment of psychophysical well-being . RESULT ( S ) The administration of testosterone undecanoate during HRT induced an increase in the PI of the middle cerebral artery and a reduction of high-density lipoprotein cholesterol . Sexual desire and satisfaction were greatly improved . CONCLUSION ( S ) In postmenopausal women , and rogen supplementation during HRT can partially counteract the beneficial effects of estrogens on cerebral vascular reactivity and lipid profiles , but sexual desire and satisfaction are greatly improved",
"BACKGROUND The frequency of bone loss among women using postmenopausal hormone therapy is unknown . METHODS We used data from the Postmenopausal Estrogen/Progestin Interventions Trial to address the frequency of bone loss among women using postmenopausal hormone replacement therapy . Of 701 women r and omized to active treatment ( conjugated equine estrogens alone or in combination with 1 of 3 progestins ) , 538 ( 76.7 % ) were adherent and had replicate bone mineral density ( BMD ) measures at baseline , 12 months , and 36 months . Of 174 placebo-assigned women , 132 ( 75.9 % ) were similarly eligible . Replicate BMD measures were used to calculate within-person measurement errors , which were then used to delineate cut points that defined bone losers with 97.5 % , 95.0 % , 90.0 % , or 75.0 % confidence . RESULTS At the lumbar spine , during the first 12 months , 1.5 % of hormone users lost BMD with 97.5 % confidence , corresponding to a decline of -3 % per year ; during months 12 to 36 , only 0.6 % of treated women lost spinal BMD to this degree . An annual loss of -1 % or more was the criterion for spinal bone loss at the 75.0 % confidence level ; 5.1 % and 8.0 % of hormone users met this criterion in the first year and in months 12 to 36 , respectively . For the total hip , during the first 12 months , 2.3 % of hormone-adherent women lost -3.0 % per year or more , the 97.5 % confidence definition of loss ; 0.4 % were so classified during months 12 to 36 . To be 75.0 % confident of hip BMD loss , a -1.0 % per year decline in BMD was required ; using this criterion , 14.5 % and 11.8 % of hormone users lost total hip BMD between 0 to 12 and 12 to 36 months , respectively . Among hormone-adherent women , at the spine and hip , there was virtually no overlap between women classified as bone losers in the first 12 months and those classified as such in the last 24 months . With 95.0 % certainty , corresponding to an approximate loss of -2.5 % at the spine and hip , 31.3 % and 11.7 % of placebo-adherent women lost spinal BMD in the first 12 and last 24 months , respectively . Parallel figures for the hip were 32.3 % and 7.9 % , respectively . CONCLUSION Bone loss while taking postmenopausal hormones is rare , and bone loss among untreated women is far from universal",
"& NA ; Various parameters of sexual functioning were assessed in a prospect i ve , crossover investigation of 53 surgically menopausal women . Patients r and omly received either an estrogen‐ and rogen combined preparation , an estrogen‐alone drug , an and rogen‐alone drug , or a placebo . Also included were a group of women who had undergone hysterectomy and whose ovaries had been left intact . Two treatment phases , each of 3 months ' duration , were separated by an intervening placebo month . Additionally , plasma levels of total estrogens and testosterone were assayed four times during the study concurrent with monitoring of sexual behaviors . It was clear that exogenous and rogen enhanced the intensity of sexual desire and arousal and the frequency of sexual fantasies in hysterectomized and oophorectomized women . However , there was no evidence that testosterone affected physiologic response or interpersonal aspects of sexual behavior . These findings suggest that the major impact of and rogen in women is on sexual motivation and not on sexual activity per se",
"To observe the effects of and rogen replacement on neuropsychological measures in menopausal women , healthy menopausal women already using replacement estrogen were studied in a r and omized , double-blind , active placebo-controlled , crossover comparison between two 8-week periods of treatment with ( 1 ) 0.625 mg oral esterified estrogen ( E ) alone and ( 2 ) in combination with 1.25 mg oral methyltestosterone ( meT ) . After an initial baseline session , data were gathered at the end of two treatment periods . Scores on st and ardized psychological tests and computerized reaction times were compared between treatments , as was an overall outcome score that combined all measures . Added meT significantly improved scores on a test of complex information processing , the Switching Attention Test , but not on other tests . Mean outcome score showed no net change and wide variation . Fourteen subjects had outcome scores > 1 SD from the mean , and 21 had no change . In the estrogen alone condition , three measures predicted favorable outcome with added meT : surgically compromised ovarian function , fewer physical symptoms , and higher score on a self-image measure of creativity . Added meT treatment may improve complex information processing . Despite wide disparities in outcome , an increased chance of overall improvement may be predicted by specific pretreatment measures",
"CONTEXT Despite decades of accumulated observational evidence , the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain . OBJECTIVE To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States . DESIGN Estrogen plus progestin component of the Women 's Health Initiative , a r and omized controlled primary prevention trial ( planned duration , 8.5 years ) in which 16608 postmenopausal women aged 50 - 79 years with an intact uterus at baseline were recruited by 40 US clinical centers in 1993 - 1998 . INTERVENTIONS Participants received conjugated equine estrogens , 0.625 mg/d , plus medroxyprogesterone acetate , 2.5 mg/d , in 1 tablet ( n = 8506 ) or placebo ( n = 8102 ) . MAIN OUTCOMES MEASURES The primary outcome was coronary heart disease ( CHD ) ( nonfatal myocardial infa rct ion and CHD death ) , with invasive breast cancer as the primary adverse outcome . A global index summarizing the balance of risks and benefits included the 2 primary outcomes plus stroke , pulmonary embolism ( PE ) , endometrial cancer , colorectal cancer , hip fracture , and death due to other causes . RESULTS On May 31 , 2002 , after a mean of 5.2 years of follow-up , the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits . This report includes data on the major clinical outcomes through April 30 , 2002 . Estimated hazard ratios ( HRs ) ( nominal 95 % confidence intervals [ CIs ] ) were as follows : CHD , 1.29 ( 1.02 - 1.63 ) with 286 cases ; breast cancer , 1.26 ( 1.00 - 1.59 ) with 290 cases ; stroke , 1.41 ( 1.07 - 1.85 ) with 212 cases ; PE , 2.13 ( 1.39 - 3.25 ) with 101 cases ; colorectal cancer , 0.63 ( 0.43 - 0.92 ) with 112 cases ; endometrial cancer , 0.83 ( 0.47 - 1.47 ) with 47 cases ; hip fracture , 0.66 ( 0.45 - 0.98 ) with 106 cases ; and death due to other causes , 0.92 ( 0.74 - 1.14 ) with 331 cases . Corresponding HRs ( nominal 95 % CIs ) for composite outcomes were 1.22 ( 1.09 - 1.36 ) for total cardiovascular disease ( arterial and venous disease ) , 1.03 ( 0.90 - 1.17 ) for total cancer , 0.76 ( 0.69 - 0.85 ) for combined fractures , 0.98 ( 0.82 - 1.18 ) for total mortality , and 1.15 ( 1.03 - 1.28 ) for the global index . Absolute excess risks per 10 000 person-years attributable to estrogen plus progestin were 7 more CHD events , 8 more strokes , 8 more PEs , and 8 more invasive breast cancers , while absolute risk reductions per 10 000 person-years were 6 fewer colorectal cancers and 5 fewer hip fractures . The absolute excess risk of events included in the global index was 19 per 10 000 person-years . CONCLUSIONS Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy postmenopausal US women . All-cause mortality was not affected during the trial . The risk-benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases , and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD",
"BACKGROUND The main goals of estrogen replacement therapy ( ERT ) are the prevention of osteoporosis and cardioprotection and the improvement of quality of life ( QL ) . And rogens and tibolone therapy may increase bone mineral density ( BMD ) to a greater extent than ERT and offer an increase in QL . Lipid and cardiovascular effects , however , are still a major concern . AIM To evaluate whether the addition of a weak and rogen to ERT may improve postmenopausal bone loss and sexual activity without adverse effects on lipid pattern and to compare these effects with those observed after tibolone therapy . SUBJECTS AND METHODS This prospect i ve study enrolled 120 surgical postmenopausal women ; of these , 96 completed the 1-year follow-up . Patients were allocated to one of four groups . The first group ( A ; n = 23 ) received 4 mg of estradiol valerate plus 200 mg of enanthate of dihydro and rosterone i m monthly . The second group ( E ; n = 26 ) received 50 microg/day of transdermal 17-b-estradiol continuously ; the third ( T ; n = 23 ) received 2.5 mg of tibolone every day ; and finally , the fourth group ( C ; n = 24 ) constituted a treatment-free control group . Bone mass ( dual X-ray absorptiometry ) , serum total cholesterol , HDL , LDL , triglycerides , apolipoproteins A1 and B and sexual activity were evaluated before starting therapy and at the end of follow-up . RESULTS All active treatment groups showed an increase in BMD . This increase was higher in the A treatment group ( 4.08 % P Sexuality improved significantly with therapy ; however , tibolone and and rogens increased scores to a greater extent than ERT . And rogen therapy was associated with significant increases in total cholesterol , LDL and triglycerides . Cholesterol and LDL fall into groups E and T , HDL into groups A and T and triglycerides in group T only . CONCLUSION The combined regimen of and rogens and ERT increased vertebral bone mass and enhance sexual activity in postmenopausal women equal to that of tibolone and to a greater extent than ERT alone ; its effects on lipids , however , are clearly adverse",
"In a double-blind trial oestradiol , oestradiol/testosterone , or placebo implants were assessed for their effects on psychological symptoms in women attending a menopause clinic . After two months , women receiving active treatment scored better than the placebo group on a self-rating scale of distress , on anxiety , and on depression ( p less than 0.05 ) . Postmenopausal but not perimenopausal women improved after placebo , and at 4 months the scores in the three groups no longer differed significantly",
"background Coronary heart disease ( CHD ) is the leading cause of mortality in women , with an incidence that increases after menopause , hence suggesting a cardioprotective role of oestrogen . Menopause also results in a decline in and rogen levels with result ing symptoms of decreased libido and sexual dysfunction . Recently , there has been a growing interest in the treatment of postmenopausal women with and rogens . However , no data are available on plasma viscosity and fibrinogen levels in postmenopausal women on combined oestrogen/ and rogen therapy",
"OBJECTIVE To compare the effects of estrogen with estrogen- and rogen treatment on vaginal blood flow velocity and fingertip postocclusive hyperemic blood flow response . DESIGN Prospect i ve , r and omized , parallel , double-blind study . SETTING Healthy human volunteers in an academic research environment . PATIENT(S ) Postmenopausal women receiving estrogen replacement therapy for at least 12 months and treated with placebo before this investigation . INTERVENTION(S ) Esterified estrogens or esterified estrogen + methyltestosterone were administered orally ; laser Doppler velocimetry was used to determine vaginal and fingertip blood flow responses at baseline and after 4 and 8 weeks of daily drug administration . MAIN OUTCOME MEASURE(S ) Fingertip postocclusive area under curve ( AUC ) ; vaginal blood flow velocities . RESULT ( S ) The AUC for postocclusive fingertip blood flow and vaginal blood flow increased to a greater extent in the estrogen- and rogen group , but changes were not statistically significant between groups . CONCLUSION ( S ) Estrogen- and rogen treatment does not diminish the vasodilator effects of estrogen treatment in postmenopausal women",
"55 postmenopausal women on established hormone replacement therapy were treated with either oestradiol and testosterone implants or placebo at the time of return of climacteric symptoms . Their response to therapy was assessed prospect ively . The statistically highly significant levels of symptom relief that followed an oestradiol and testosterone implant were contrasted sharply with the lack of any significant relief with placebo . Despite the success of oestradiol and testosterone implants in relieving symptoms of the climacteric , symptoms returned once the treatment was stopped . Evidence is presented that it is the fall in hormone levels rather than the level itself that provokes the return of climacteric symptoms",
"OBJECTIVES To eluci date if percutanous treatment with 10 mg testosterone per day could enhance sexuality and psychological well-being in postmenopausal women presenting problems with low libido . Secondary to study the influence on blood lipids , hemoglobin and erythropoietin levels . METHODS Fifty-three postmenopausal women participated . As a complement to their already on-going HRT , 10 mg of a testosterone gel ( Testogel , Besins-Iscovesco ) or placebo was administered . Treatment continued for three plus three months in a double blind , r and omized , crossover design . RESULTS The scores concerning \" frequency of sexual activity , orgasm and intercourse \" , \" sexual arousal , fantasies and enjoyment \" , \" satisfaction with orgasms \" , and \" interest in sex \" were all significally improved for testosterone addition as compared to placebo both before and after crossover . Testosterone levels increased more than 10-fold during treatment while DHT-levels were more than doubled . Estrogen levels were not affected during the addition of testosterone . Liver enzymes , total cholesterol , triglycerides , HDL and LDL revealed no significant differences between any of the periods or groups . Endometrial thickness did not change significantly during treatment . Hemoglobin and erythropoietin remained unchanged . No significant differences in the number of experienced side effects were found . CONCLUSION Testosterone gel of 10 mg had positive effects on several aspects of sexual life such as frequency of sexual activity , orgasm , arousal , fantasies and sexual interest in postmenopausal women on HRT . Several psychological variables were positively influenced . The given dose result ed in too high serum levels . Even if no negative effects were observed , monitoring of serum levels and a decreased dose should be considered in future studies",
"A double-blind , r and omized , placebo-controlled study was conducted in 46 postmenopausal women with established osteoporosis in order to assess the long-term effects of n and rolone decanoate on the bone mineral density ( BMD ) of the lumbar vertebrae and of the distal third of the radius and on the biochemical markers of bone turnover . The patients received intramuscular injections of placebo or 50 mg n and rolone decanoate every 3 weeks for 18 months . Thirty-two of the initial 46 patients completed 1 year of study and 25 completed the whole study period of 18 months . Overall , vertebral BMD increased by 2.9 % in the n and rolone decanoate group and fell by 2.3 % in the placebo group . Radial BMD showed a slight but transient improvement , with a subsequent return to basal levels in the n and rolone decanoate group , whereas there was a progressive decrease in the placebo group . Patients treated with n and rolone decanoate also complained less of bone pain . Urinary hydroxyproline decreased significantly in treated patients , whereas osteocalcin tended to increase , but the change was not significant . HDL cholesterol concentrations decreased only slightly and haemoglobin increased significantly in the n and rolone decanoate group . Two patients treated with n and rolone decanoate withdrew from the study because of hirsutism and hoarseness . The results indicate that n and rolone decanoate exerts positive effects on vertebral BMD and on bone pain in patients with established postmenopausal osteoporosis",
"In a prospect i ve , double-blind , crossover study , it was found that surgically menopausal women who received an estrogen drug alone and those who were given a combined estrogen- and rogen preparation reported a significantly reduced frequency of hot flushes compared to a placebo group ( p less than 0.01 ) coincident with their higher total plasma estrogen levels ( p less than 0.01 ) . The administration of testosterone alone , however , was ineffective in alleviating hot flushes , even though these patients had plasma estrogen values that were not different from those of women with intact ovaries . It was proposed that , in women with very low levels of endogenous estrogens , changes in sex hormone-binding globulin ( SHBG ) concentrations induced by exogenous testosterone may reduce the amount of non-SHBG-bound estrogens , thereby obviating estrogenic effects on hot flushes",
"Previous studies indicated an enhanced capability of divergent creative thinking in young women during the ovulatory phase , which expressed itself also by an increased dimensional complexity of ongoing electroencephalographic ( EEG ) activity . Considering the enhanced plasma levels of estrogen and testosterone characterizing the ovulatory phase , we tested whether short-term administration of estrogen or testosterone in postmenopausal women with constantly low levels of gonadal steroids induces similar changes in divergent thinking . In two placebo-controlled cross-over studies , healthy postmenopausal women ( n=12 , in each study , mean age 58 years , range 47–65 years ) were treated transdermally over 3 days with estrogen and testosterone , respectively , at doses inducing plasma hormone concentrations comparable with those observed in young women around ovulation . Capabilities of divergent thought and convergent analytical thought , performance on motor perseveration , and verbal memory were examined . EEG activity was recorded while subjects performed on tasks of thinking and during mental relaxation . Estrogen impaired divergent thinking ( p enhanced convergent thinking , motor perseveration , and memory for the initial word list ( p , EEG dimensional complexity was reduced ( p performance on some of the divergent thinking tasks ( p increase EEG dimensional complexity during divergent thinking . Data indicate a differential sensitivity of modes of thinking to short-term treatment with estrogen and testosterone in postmenopausal women",
"Objective : To compare the effect of esterified estrogens and methyltestosterone versus esterified estrogens alone on diminished sexual interest in surgically menopausal women . Design : This r and omized , double-blind study compared the effect of combined esterified estrogens ( 1.25 mg ) and methyltestosterone ( 2.5 mg ) ( EE/MT ) versus esterified estrogens ( 1.25 mg ) alone ( EE ) for 8 weeks . Several different sexual function question naires were used to measure response to therapy . Changes from baseline in sexual interest/function and hormone levels were evaluated after 4 and 8 weeks of treatment . Results : A total of 102 women were r and omized into the study ; 52 ( age range , 32 - 61 years ) to EE/MT and 50 ( age range , 33 - 62 years ) to EE . After 8 weeks , significant differences between treatments were not seen in the Changes in Sexual Functioning Question naire ( CSFQ-F-C ) sexual desire/interest subscale score , the primary efficacy variable . In contrast statistically significant between-treatment differences were found for several secondary efficacy variables including Menopausal Sexual Interest Question naire ( MSIQ ) sexual interest/desire score , CSFQ-F-C arousal/erection subscale score and Women 's Health Question naire sexual functioning subscale score . The mean serum concentration of bioavailable and free testosterone significantly increased , approximately doubling between baseline and the end of the study in patients receiving EE/MT , with a significant ( P mean serum concentration of sex hormone-binding globulin significantly decreased to less than one third of the pretreatment levels in patients receiving EE/MT ( P tolerated . Conclusions : The mixed results seen with the different sexual function question naires may be due to the CSFQ-F-C 's lack of specificity for this population . Increased levels of bioavailable and free testosterone paralleled the improved MSIQ item scores . Both the EE and EE/MT treatments were well tolerated",
"Objective : To evaluate the effect of adding testosterone undecanoate 40 mg daily to estrogen replacement on sexual function , psychological well-being and self-esteem in surgically postmenopausal women . Methods : A letter of invitation to participate in the study was mailed to women who had undergone hysterectomy and bilateral oophorectomy for benign disorders during 1990 - 98 . Fifty women , 45 - 60 years old , were consecutively recruited and r and omly assigned to oral treatment with testosterone undecanoate 40 mg plus estradiol valerate 2 mg daily or placebo plus estradiol valerate 2 mg daily for 24 weeks . A double-blind design was chosen , with cross-over to the other regimen for another 24 weeks of treatment . Forty-four women completed the study . Outcome included scores on McCoy 's sex scale question naire , the Psychological General Well-Being index and a self-esteem question naire , at baseline and after 24 weeks of either treatment . Serum concentrations of total testosterone , sex hormone binding globulin , free testosterone , dihydrotestosterone , and rostenedione , estradiol , follicle stimulating hormone and luteinizing hormone were analyzed at baseline and after 24 weeks of both treatment regimens . Results : After 24 weeks , both treatment regimens had significantly improved some of the sexual variables . The addition of testosterone had a significantly better effect on the sex variables ' enjoyment of sex ' , ' satisfaction with frequency of sexual activity ' and ' interest in sex ' . The total McCoy score was significantly increased by both treatments , but there was a stronger effect when testosterone was also given . Although both regimens improved psychological well-being and self-esteem , we found no significant differences between testosterone-estrogen or estrogen alone at 24 weeks . Serum levels of all and rogens , with considerable individual variation , increased significantly from baseline after 24 weeks of testosterone-estrogen treatment . Supraphysiological levels were achieved in a significant proportion of the women . Increases in estradiol and sex hormone binding globulin were less marked when testosterone was also given . Both treatments reduced gonadotropin levels . Conclusions : The addition of testosterone undecanoate improved specific aspects of sexual function more than treatment with estrogen alone . Improvements in well-being and self-esteem were similar for both treatments . If testosterone undecanoate 40 mg daily should be used for clinical treatment , regular monitoring of and rogen serum levels is needed",
"OBJECTIVE To evaluate the effects of giving testosterone undecanoate ( TU ) in addition to estrogen replacement on serum lipids in oophorectomized women . METHOD Women with surgically induced menopause ( n = 50 ) were r and omly assigned to oral treatment with 2 mg of estradiol valerate in combination with 40 mg of TU or placebo for 24 weeks . The study was double-blind with cross-over to the other regimen for further 24 weeks of treatment . Forty-four women completed the study . Their serum concentrations of total , high density lipoprotein (HDL)- and low density lipoprotein (LDL)-cholesterol , triglycerides , lipoprotein-(a ) ( Lp-(a ) ) , total testosterone , estradiol and sex hormone-binding globulin ( SHBG ) were analyzed at baseline and after 24 weeks of each treatment . RESULTS Serum levels of total testosterone increased markedly from a baseline mean of 0.8 - 4.9 nmol/l during testosterone addition . The levels of free testosterone significantly increased during the combined treatment and fell when given estrogen alone . Total and LDL-cholesterol levels were significantly reduced by both treatments as also were those of Lp-(a ) although the difference was not significant . We found a 13 % reduction in HDL-cholesterol levels when testosterone was added , but no change with estrogen alone . Triglyceride levels were increased by estrogen treatment , but not affected by the combination of estrogen plus testosterone . CONCLUSIONS These findings suggest that 40 mg of TU can be given in addition to estrogen replacement with only little side-effects on the pattern of circulating lipids . Although supraphysiological concentrations of testosterone were induced a significant reduction in total and LDL-cholesterol levels occurred",
"Background Testosterone ( Te ) , oestradiol , GH and IGF‐I concentrations fall in postmenopausal women",
"The present study was undertaken to determine whether the addition of an and rogen to estrogen therapy in postmenopausal women would alter the skeletal response as determined by measurements of markers of bone formation and resorption . Postmenopausal women were treated for 9 weeks with either a combination of 1.25 mg esterified estrogen and 2.5 mg methyltestosterone ( E+A ) or 1.25 mg conjugated equine estrogen ( CEE ) . Both groups showed a similar decrease in urinary excretion of the bone resorption markers , deoxypyridinoline , pyridinoline , and hydroxyproline . Patients treated with CEE showed decreases in the serum markers of bone formation , bone-specific alkaline phosphatase , osteocalcin , and C-terminal procollagen peptide . In contrast , subjects treated with E+A showed increases in these markers of bone formation . CEE increased , and E+A decreased serum levels of sex hormone-binding globulin as well as triglycerides and high density lipoprotein levels . Only CEE significantly reduced low density lipoproteins . Both regimens were effective in reducing postmenopausal somatic symptoms , but only E+A had a significant effect on psychological symptoms . We conclude that short term administration of and rogen with estrogen may reverse the inhibitory effects of estrogen on bone formation . Long term studies are needed to determine the relative benefits and risks of the combination of estrogen and and rogen and whether this results in greater increases in bone mass and strength",
"The investigation of estrogen and /or and rogen administration on physical and psychological symptoms in the surgical menopause was carried out in a prospect i ve , double-blind , crossover design . When patients who received either a combined estrogen- and rogen drug or and rogen alone were compared with those who received estrogen alone or placebo , energy level , well-being , and appetite were increased ( p less than 0.01 ) . The and rogen-containing preparations also induced lower somatic , psychological , and total scores on the menopausal index . Superior functioning in the and rogen-treated groups occurred in association with higher plasma testosterone levels during the treatment phases ( p less than 0.01 ) . These data suggest that reduced levels of circulating testosterone subsequent to bilateral oophorectomy may play an important role in the development of physical and psychological symptoms that are frequent sequelae of this surgical procedure",
"Objective : During the past few years serious concern has been raised about the safety of combined estrogen/progestogen hormone therapy , in particular about its effects on the breast . Several observations suggest that and rogens may counteract the proliferative effects of estrogen and progestogen in the mammary gl and . Thus , we aim ed to study the effects of testosterone addition on breast cell proliferation during postmenopausal estrogen/progestogen therapy . Design : We conducted a 6-month prospect i ve , r and omized , double-blind , placebo-controlled study . A total of 99 postmenopausal women were given continuous combined estradiol 2 mg/norethisterone acetate 1 mg and were equally r and omly assigned to receive additional treatment with either a testosterone patch releasing 300 & mgr;g/24 hours or a placebo patch . Breast cells were collected by fine needle aspiration biopsy at baseline and after 6 months , and the main outcome measure was the percentage of proliferating breast cells positively stained by the Ki-67/MIB-1 antibody . Results : A total of 88 women , 47 receiving active treatment and 41 in the placebo group , completed the study . In the placebo group there was a more than fivefold increase ( P total breast cell proliferation from baseline ( median 1.1 % ) to 6 months ( median 6.2 % ) . During testosterone addition , no significant increase was recorded ( 1.6 % vs 2.0 % ) . The different effects of the two treatments were apparent in both epithelial and stromal cells . Conclusions : Addition of testosterone may counteract breast cell proliferation as induced by estrogen/progestogen therapy in postmenopausal women",
"Women experience somatic , mood , energy , and libido changes during menopause . Testosterone replacement therapy is being prescribed in conjunction with estrogen replacement therapy ( ERT ) for these symptoms . Little is known about women ’s perceptions of the benefits and risks of testosterone , so an Internet survey was conducted to elicit women ’s perceptions of the effects on mood , energy , sexuality , and somatic symptoms . A sample of 61 women primarily from the United States and Canada participated in the survey ; one woman from Germany and one from Sweden also took part in the survey . Participants reported significantly improved sexuality and improved mood and vigor , with a decline in fatigue . Of the 7 somatic complaints assessed , improvements were noted in 5 ( sleep disturbances , hot flashes , night sweats , vaginal dryness , and appetite ) . A prospect i ve clinical trial is needed to confirm these results",
"Objective The cardiac syndrome X is described as the triad of angina pectoris , a positive exercise test for myocardial ischemia , and angiographically smooth coronary arteries . Although syndrome X does not result in an increased risk of cardiovascular mortality , the symptoms are often troublesome and unresponsive to conventional antianginal therapy . The majority of patients are postmenopausal , and estrogen therapy can alleviate anginal symptoms . We investigated the effect of esterified estrogens combined with methyltestosterone ( Estratest ) on quality of life in postmenopausal women with syndrome X. Design Patients were withdrawn from antianginal therapy . Sublingual nitrates were allowed for treatment of anginal episodes . Patients underwent treadmill testing , and quality of life was assessed by using the Short Form-36 and Cardiac Health Profile question naires after the women had received 8 weeks of Estratest or identical placebo in a r and omized , double-blind , cross-over study . Results Nineteen patients were r and omized , and 16 patients completed the protocol . Plasma 17&bgr;-estradiol concentrations were significantly increased by Estratest ; however , total testosterone levels were not . The “ emotional ” score of the Cardiac Health Profile question naire was significantly improved after Estratest use compared with placebo ( p = 0.03 ) ; however , there was no significant change in the Short Form-36 question naire for any variable . Estratest significantly increased systolic blood pressure and rate pressure product at rest but had no effect on exercise parameters . Time to onset of chest pain during exercise was also unaffected . Conclusions We have demonstrated a beneficial effect of Estratest on emotional well-being in postmenopausal women with cardiological syndrome X. There was no significant treatment effect on exercise parameters , including time to onset of chest pain",
"The Heart and Estrogen/progestin Replacement Study ( HERS ) was a r and omized clinical trial of postmenopausal hormone use in 2763 women ( 1 ) . Unlike previous observational studies , it included only women with previous coronary heart disease , and hormone therapy was exclusively oral conjugated estrogen plus progestin . In HERS , overall rates of recurrent coronary heart disease did not differ between the treated and nontreated groups . However , in additional , unplanned analyses , the results of HERS were not uniformly None . A marked and statistically significant trend toward decreasing risk was observed with increasing duration of hormone use ( 1 ) ; in the first year , the rate of major coronary events was 52 % higher in the treatment group . In the second year , rates were equal , but during the final fourth and fifth years , women assigned to hormone therapy had a 33 % lower risk for coronary events . The overall results of HERS and the apparent changes in risk over time were both unexpected . Since no previous investigations have examined the relation between duration of hormone use or combined hormone treatment to secondary prevention of coronary heart disease events , it remains unclear whether the time trend was authentic and whether the observations in HERS are limited to that hormone regimen ( 2 ) . In addition , we were interested in underst and ing how women 's use of hormone therapy before their initial coronary disease event might affect the outcome of their hormone use after that event . In HERS , duration of hormone therapy before trial entry was necessarily disregarded ( although 23 % of participants had previously taken hormones ) ; thus , it remains unknown how , or whether , to account for hormone use or duration of use before a patient 's initial coronary event . To further examine the effects of duration of hormone therapy and to explore the effect of different hormone regimens , we investigated the relation between postmenopausal hormone use and secondary prevention of major coronary events in 2489 women with established coronary disease in the Nurses ' Health Study , a large observational cohort . Methods The Nurses ' Health Study Cohort The Nurses ' Health Study began in 1976 , when 121 700 female nurses 30 to 55 years of age completed a mailed question naire about postmenopausal hormone use and medical history , including cardiovascular disease and its risk factors . Every 2 years , we mail follow-up question naires to the original participants to up date information on risk factors and to identify newly diagnosed cases of major illnesses . The total follow-up for the cohort to date exceeds 92 % . Sample for Analysis For this analysis , we limited the cohort to postmenopausal women who reported a previous myocardial infa rct ion or documented coronary atherosclerosis ( coronary artery bypass graft surgery , percutaneous coronary revascularization , or angiographic evidence of 70 % occlusion of one or more major coronary arteries ) . Such women were identified on the baseline question naire in 1976 ; postmenopausal women who reported one of these conditions on a subsequent follow-up question naire were added to the sample at that time . Women ranged in age from 34 to 73 years at entry into the sample for analysis ; 60 % of women had a natural menopause . These criteria closely parallel those used in HERS ( 1 ) ; however , in HERS , women with hysterectomy were excluded , occlusion was defined as at least 50 % , and participants ranged in age from 44 to 79 years . We classified women as postmenopausal from the time of natural menopause or hysterectomy with bilateral oophorectomy . Women who underwent hysterectomy without bilateral oophorectomy were considered postmenopausal when they reached the age at which natural menopause had occurred in 90 % of the cohort ( 54 years for smokers and 56 years for nonsmokers ) ( 3 ) . The women 's reports of age at menopause and type of menopause were highly accurate ( 4 ) . In HERS , women with a history of breast or endometrial cancers were excluded . In the current study , we excluded women who reported stroke or cancer ( except nonmelanoma skin cancer ) on the 1976 baseline question naire at the outset and excluded women from further follow-up if they reported these diseases on a subsequent biennial question naire . This was done to avoid potential bias , in which major diseases such as stroke or cancer may have caused women to alter their hormone use and may be related to risk for coronary heart disease . This type of bias could not have occurred in a r and omized trial , such as HERS . Two hundred forty-eight postmenopausal women with coronary disease entered the analysis in 1976 , and 2241 postmenopausal women were added during follow-up as they reported heart disease ; thus , 17 239 person-years accrued during up to 20 years of follow-up from 1976 to 1996 . Ascertainment of Hormone Use In 1976 , women were asked about current and past use and duration of hormone therapy ; this information was up date d on each biennial question naire . Beginning in 1978 and on each subsequent question naire , we collected information on type of hormone used . For the period 19761978 , we assigned women to the type of hormone reported on the 1978 question naire . If no data were available on hormone therapy for a given 2-year period , those women were assigned to a missing category for that period . In the HERS trial , women who had taken hormones in the 3 months before their screening visit were excluded ( although 23 % to 24 % of the enrolled participants had previously used hormones ) . Because this study is observational , we could not impose a 3-month washout period ; thus , we could not duplicate that aspect of the HERS protocol . We analyzed duration of hormone use in two different ways . In the main analysis , we performed a HERS replication and used a method similar to that in HERS to calculate duration of use . In HERS , duration of hormone therapy began to accrue at r and omization ( regardless of previous hormone use ) ; r and omization occurred sometime after the participant 's initial coronary disease event . Therefore , in our main analysis , we began accruing duration of hormone use for each participant immediately after her initial coronary disease event ( regardless of hormone use before this event ) . For example , if a woman began hormone therapy in 1984 and had a revascularization procedure in 1986 , her duration of use in 1990 would be 4 years . In an alternative analysis , we considered the women 's full experience with hormone therapy ( both before and after the initial coronary disease event ) . Thus , duration of hormone use accumulated continuously from start to termination of therapy . For example , if a woman began hormone therapy in 1984 and had a revascularization procedure in 1986 , her duration of use in 1990 would be 6 years . Similar to HERS participants , 29 % of the nurses had taken hormones before their first coronary disease event . Identification of Second Coronary Disease Events Similar to HERS , in our study the category of recurrent major coronary heart disease included nonfatal myocardial infa rct ion and fatal coronary disease that occurred between the return of the 1976 question naire and 1 June 1996 . Nurses who reported a nonfatal infa rct ion were asked for permission to review their medical records . Nonfatal myocardial infa rct ions were confirmed by hospital records if they met the World Health Organization criteria ( 5 ) ( symptoms , plus either elevated cardiac enzyme levels or diagnostic electrocardiograms ) . Infa rct ions requiring hospitalization and corroborated by interview or letter , but for which medical records were unobtainable , were included as probable . Most deaths were reported by the participants ' families . Every 2 years , we search the National Death Index ( 6 ) to identify deaths among nonrespondents ; follow-up for death remains more than 98 % complete to date . For all deaths possibly attributable to cardiovascular causes , we requested permission from relatives ( subject to state regulations ) to review the medical records . Deaths were considered due to coronary disease if medical records or autopsy findings confirmed a fatal myocardial infa rct ion . Cases in which coronary disease was listed on the death certificate as the underlying cause of death and another , more plausible cause could not be discerned were included as probable cases , since the nurse was known to have had coronary disease before death . The investigators conducted all interviews and medical record review s without knowledge of participants ' hormone use status . In separate analyses , results for probable cases of coronary disease ( 20 % ) were almost identical to those for confirmed cases ( 80 % ) ; thus , we present data from analyses in which confirmed and probable cases are combined . Statistical Analysis For each participant , person-months were allocated to hormone categories according to the baseline data and were up date d every 2 years according to information received on follow-up question naires . Examination of type of hormone therapy was limited to users of oral conjugated estrogen with or without oral medroxyprogesterone acetate , as this was the most common hormone regimen . If information on hormone use was missing during a follow-up period , then person-time was assigned to a missing category for that time period . So that the study would be prospect i ve , we established hormone status during each 2-year follow-up period from women 's reports at the start of the time period ; thus , we probably underestimate duration of use by an average of 1 year in both the main analysis and the alternate analysis . Follow-up for a participant ended with diagnosis of myocardial infa rct ion , death , or 1 June 1996 , whichever came first . The analysis is based on incidence rates , using person-months of follow-up as the denominator . We used relative risk as the measure of association , defined as the incidence of second major coronary events among women in various categories of hormone use divided by the rate among women who never used hormones",
"OBJECTIVE To investigate somatic symptom relief , gonadotropin secretion , and endogenous and rogen bioavailability ( protein-bound and free ) during 3 months of estrogen- and rogen therapy or matched estrogen-only replacement therapy . DESIGN Ninety-three naturally menopausal out patients with 6 or more months of amenorrhea , who were experiencing mild-to-moderate vasomotor symptoms , were r and omized to receive one of five treatments : oral esterified estrogens ( 0.625 mg or 1.25 mg ) , oral esterified estrogens combined with methyltestosterone ( 0.625 mg combined with 1.25 mg methyltestosterone or esterified estrogens 1.25 mg combined with 2.5 mg methyltestosterone ) , or placebo for 12 weeks . All treatments were preceded by a 4-week placebo lead-in period . RESULTS Patients receiving the lower dose of estrogen- and rogen therapy had fewer somatic menopausal symptoms than patients receiving the lower dose estrogen ( 0.625 mg ) , and they experienced somatic symptom relief similar to those patients receiving the higher dose of estrogen ( 1.25 mg ) . Significantly greater luteinizing hormone suppression ( p Sex hormone-binding globulin increased significantly in both estrogen-treated groups ( p estrogen-only preparation significantly reduced and rostenedione ( p dehydroepi and rosterone sulfate ( p estrogen- and rogen therapy was similar to higher dose estrogen-only treatment . The greater efficacy of combination therapy on somatic symptoms could be mediated by the same mechanism responsible for the suppressive effects of estrogen- and rogen therapy on luteinizing hormone secretion . The marked differences in circulating levels of sex hormone building globulin , which were increased by estrogen and decreased by estrogen- and rogen , and the result ing impact on bioavailable and rogens and estrogens could also explain the differential somatic relief with both treatments . Endogenous adrenal and rogens were lower in women treated with esterified estrogens 1.25 mg/day , suggesting that estrogen therapy can produce a significant hypo and rogenic state by inhibiting production or accelerating clearance of adrenal and rogens",
"OBJECTIVE To evaluate the benefits and risks of hormone replacement therapy ( HRT ) combined with methyltestosterone ( MT ) in postmenopausal women with sexual dysfunction . DESIGN This study was a r and omized , double-blind , placebo-controlled and crossover trial . Eighty-five women using HRT were divided into four treatment groups : GI-HRT plus placebo for 4 months ; GII-HRT plus MT 2.5mg/day for 4 months ; GIII-HRT plus placebo for 2 months and then replaced with HRT plus MT 2.5mg/day for 2 months ; GIV-HRT plus MT 2.5mg/day and then replaced with HRT plus placebo for 2 months . Blood was collected at baseline , after 2 months ( T1 ) and 4 months ( T2 ) of treatment for hormone determinations of estradiol , FSH , total and free testosterone , GOT , GPT , glucose , total and fractions of cholesterol and triglycerides . All participants answered clinical questions and a vali date d question naire of modified McCoy 's sex scale . RESULTS The association of HRT with MT 2.5mg/day did not significantly change liver enzymes or increase cardiovascular risk factors . The patients of GII , GIIII and GIV when using MT presented amelioration of sex symptoms , mainly satisfaction and desire ( p problem score results as compared to GIII at T2 ( 1.5+/-0.6 ) . CONCLUSION All data suggest that combined HRT- and rogen therapy may be beneficial for postmenopausal women receiving HRT who continue to complain of sexual difficulties or for postmenopausal women with sexual complaints who are not undergoing estrogen therapy",
"Epidemiological and psychophysiological data suggest that groups that differ in reproductive hormones and stress responses also differ in risk for cardiovascular disease . To evaluate the effects of hormone therapy on women 's cardiovascular responses to laboratory stressors , 89 healthy postmenopausal women were tested twice , before and after exposure for about 8 weeks to one of the five conditions : placebo , Estratab ( primarily estrone ) , Estratab plus Prometrium ( micronized progesterone ) , Estratab plus Provera ( synthetic progestin ) , and Estratest ( same estrogen as in Estratab plus methyltestosterone ) . Results showed that women assigned to Estratab plus Prometrium and Estratest had diminished systolic blood pressure responses to stress upon retesting , whereas the other groups did not change in the level of their responses . Women assigned to Estratab plus Prometrium had diminished diastolic blood pressure responses during a speech stressor upon retesting , whereas women assigned to Estratab plus Provera increased . Our findings show that hormone therapy does affect women 's stress responses , but they do not provide a simple explanation as to why groups at high and low risk for cardiovascular disease differ in reproductive hormones and stress responses",
"Objective : Evaluation of the use of testosterone therapy for hypoactive sexual desire disorder ( HSDD ) after oophorectomy has mostly involved women treated with oral estrogen preparations . We investigated the efficacy and safety of a testosterone patch in surgically menopausal women receiving concurrent transdermal estrogen . Design : Women with HSDD after oophorectomy , for whom this was a concern , who were using transdermal estrogen , were recruited to a 24-week , r and omized , double-blind , placebo-controlled trial in Europe and Australia . Patients were r and omly allocated to placebo ( n = 40 ) or testosterone 300 & mgr;g/day ( n = 37 ) treatment . Primary endpoints were changes in sexual desire measured by the sexual desire domain of the Profile of Female Sexual Function and the frequency of satisfying sexual activity at 24 weeks . Results : Sixty-one women ( 79 % ) completed the trial . All subjects who received at least one application of study medication were included in analysis . The testosterone-treated group experienced a significantly greater change from baseline in the domain sexual desire score compared with placebo ( change from baseline , 16.43 versus 5.98 ; P = 0.02 ) . The domain scores for arousal , orgasm , decreased sexual concerns , responsiveness , and self-image as well as decreased distress were also significantly greater with testosterone therapy than placebo . The frequency of satisfactory sexual events increased but was not statistically different between treatment groups ( P = 0.06 ) Adverse events occurred with similar frequency in both groups , and no serious risks of therapy were observed Conclusions : In this study , transdermal testosterone therapy via a skin patch improved sexual desire and other sexual function domains . It was well tolerated in these oophorectomized women with HSDD receiving concomitant transdermal estrogen",
"Objective : To compare the efficacy and safety of esterified estrogens with and without methyltestosterone . Methods : Twenty-six women participated in a doubleblind r and omized trial for 6 months . Outcome measures included serum total and lipoprotein-bound cholesterol , vasomotor symptoms , vaginal cytology and endometrial histology , and chemistry values . Analysis of variance and t test statistics were used to assess differences . Results : After 6 months of therapy , the treatment groups were comparable with regard to symptom scores , vaginal cytology and endometrial histology scores , and clinical laboratory test values . Treatment with esterified estrogens plus methyltestosterone significantly decreased total cholesterol , high-density lipoprotein cholesterol ( HDL ) , HDL2 , HDL3 , and apolipoprotein Al compared to esterified estrogens alone . Conclusions : Esterified estrogens with or without methyltestosterone were effective at reducing menopausal symptoms and were well tolerated over 6 months of continuous treatment . A significant decrease in cholesterol and apolipoproteins in the estrogen plus methyltestosterone group suggests a potentially adverse impact on the beneficial effect normally imparted by estrogen therapy",
"OBJECTIVE Little is known about metabolic effects of testosterone treatment in postmenopausal women . The aim of the study was to compare the treatment effects of testosterone , estrogen , and testosterone plus estrogen on insulin sensitivities , body compositions , and lipid profiles in healthy postmenopausal women . DESIGN An open , r and omized clinical study with parallel group comparison . SETTING Women 's health clinical research unit at a university hospital . PATIENT(S ) Sixty-three naturally postmenopausal women participated in the study . INTERVENTION(S ) The participants were r and omly assigned to 3 months of treatment with testosterone undecanoate ( 40 mg every second day ) , estradiol valerate ( 2 mg daily ) , or the combination of both . MAIN OUTCOME MEASURE(S ) Insulin sensitivity assessed by euglycemic hyperinsulinemic clamp , body composition , and serum lipids . RESULT ( S ) Insulin-induced glucose disposal was reduced by approximately 20 % after treatment with testosterone alone , and after the combined treatment , but not by estrogen alone . Body weight , but not total body fat , increased significantly by about 1 kg in all groups . Lean body mass was significantly increased in the group of combined treatment and tended to be increased by testosterone alone . High-density lipoprotein (HDL)-cholesterol decreased significantly by testosterone treatment . In contrast , HDL-cholesterol increased , whereas low-density lipoprotein (LDL)-cholesterol and lipoprotein-(a ) [ Lp(a ) ] decreased with estradiol treatment . CONCLUSION ( S ) We conclude that 3 months of treatment with testosterone undecanoate in postmenopausal women induces insulin resistance and an adverse serum lipid profile but may increase lean body mass",
"From a longitudinal prospect i ve study , 160 women with spontaneous menopause and without steroid medication were followed during the transition from pre- to postmenopause . After 12 years 152 women were still participating in the study . Blood sample s were drawn every 6 months until 1 year after the menopause and every 12 months thereafter . Measurements of bone mineral density ( BMD ) on the forearm were performed every second year . All women routinely completed a question naire concerning symptoms frequently attributed to the climacteric period . All data were grouped around the onset of the menopause , thereby allowing longitudinal evaluation of the changes in the variables from the premenopausal to the postmenopausal period . The beginning of the perimenopausal period was characterized by transitory elevations of follicle-stimulating hormone ( FSH ) . A significant increase in serum levels of gonadotropins was observed for both FSH and luteinizing hormone ( LH ) from about 5 years before the menopause . Within the 6 month period around the menopause there was a further increase which culminated within the first postmenopausal year for LH and 2 - 3 years postmenopause for FSH . Thereafter , a continuous decrease in LH occurred over the following 8 years . With respect to FSH , there was a slight decline starting about 4 years postmenopause . During the premenopausal period an increasing frequency of inadequate luteal function or anovulation occurred and , in the postmenopausal years , the serum levels of progesterone ( P ) were invariably low . Gradually , the ratio between estrone ( E1 ) and 17-beta-estradiol ( E2 ) increased , reflecting the declining follicular steroidogenesis . A marked decrease in estrogen levels occurred during the 6 month period around the menopause , most pronounced in E2 . During the next 3 years , the levels of E2 and E1 showed an essentially parallel , moderate decline . Around the menopause , serum levels of testosterone ( T ) , delta 4- and rostenedione ( A ) and sex hormone-binding globulin ( SHBG ) showed small but significant decreases . From about 3 years postmenopause , the levels were relatively constant over the following 5 years . A decrease in BMD was observed in the postmenopause , and from about 3 years postmenopause , estradiol correlated positively with BMD . Before , as well as after the menopause , body mass index ( BMI ) showed an inverse correlation with SHBG . Postmenopausal and rostenedione correlated positively with E1 , E2 and T. BMI correlated positively with E1 and E2 . The concentrations of the free fraction of E2 and T are dependent on the levels of SHBG , which in turn has a negative correlation with BMI . The impact of this will influence the severity of symptoms , the degree of bone loss and the need for supplementary therapy",
"CONTEXT Despite decades of use and considerable research , the role of estrogen alone in preventing chronic diseases in postmenopausal women remains uncertain . OBJECTIVE To assess the effects on major disease incidence rates of the most commonly used postmenopausal hormone therapy in the United States . DESIGN , SETTING , AND PARTICIPANTS A r and omized , double-blind , placebo-controlled disease prevention trial ( the estrogen-alone component of the Women 's Health Initiative [ WHI ] ) conducted in 40 US clinical centers beginning in 1993 . Enrolled were 10 739 postmenopausal women , aged 50 - 79 years , with prior hysterectomy , including 23 % of minority race/ethnicity . INTERVENTION Women were r and omly assigned to receive either 0.625 mg/d of conjugated equine estrogen ( CEE ) or placebo . MAIN OUTCOME MEASURES The primary outcome was coronary heart disease ( CHD ) incidence ( nonfatal myocardial infa rct ion or CHD death ) . Invasive breast cancer incidence was the primary safety outcome . A global index of risks and benefits , including these primary outcomes plus stroke , pulmonary embolism ( PE ) , colorectal cancer , hip fracture , and deaths from other causes , was used for summarizing overall effects . RESULTS In February 2004 , after review ing data through November 30 , 2003 , the National Institutes of Health ( NIH ) decided to end the intervention phase of the trial early . Estimated hazard ratios ( HRs ) ( 95 % confidence intervals [ CIs ] ) for CEE vs placebo for the major clinical outcomes available through February 29 , 2004 ( average follow-up 6.8 years ) , were : CHD , 0.91 ( 0.75 - 1.12 ) with 376 cases ; breast cancer , 0.77 ( 0.59 - 1.01 ) with 218 cases ; stroke , 1.39 ( 1.10 - 1.77 ) with 276 cases ; PE , 1.34 ( 0.87 - 2.06 ) with 85 cases ; colorectal cancer , 1.08 ( 0.75 - 1.55 ) with 119 cases ; and hip fracture , 0.61 ( 0.41 - 0.91 ) with 102 cases . Corresponding results for composite outcomes were : total cardiovascular disease , 1.12 ( 1.01 - 1.24 ) ; total cancer , 0.93 ( 0.81 - 1.07 ) ; total fractures , 0.70 ( 0.63 - 0.79 ) ; total mortality , 1.04 ( 0.88 - 1.22 ) , and the global index , 1.01 ( 0.91 - 1.12 ) . For the outcomes significantly affected by CEE , there was an absolute excess risk of 12 additional strokes per 10 000 person-years and an absolute risk reduction of 6 fewer hip fractures per 10 000 person-years . The estimated excess risk for all monitored events in the global index was a nonsignificant 2 events per 10 000 person-years . CONCLUSIONS The use of CEE increases the risk of stroke , decreases the risk of hip fracture , and does not affect CHD incidence in postmenopausal women with prior hysterectomy over an average of 6.8 years . A possible reduction in breast cancer risk requires further investigation . The burden of incident disease events was equivalent in the CEE and placebo groups , indicating no overall benefit . Thus , CEE should not be recommended for chronic disease prevention in postmenopausal women",
"BACKGROUND There is increasing use of hormone replacement therapy ( HRT ) by post-menopausal women . Observational epidemiological studies have shown reductions in cardiovascular risk factors in HRT users in the USA , but no r and omized controlled trials of HRT have been carried out in the primary practice setting . Previous studies of cardiovascular risk factors have shown a variety of responses according to type of progestagen and oral or topical administration . None has examined the effect of route using an identical progestagen . OBJECTIVES Our aim was to establish differences , if any , in alteration in cardiovascular risk factors with HRT in post-menopausal women according to route of administration of HRT , oral , transdermal and implant , using first oestrogen alone then oestrogen plus norethisterone , or testosterone for implant . METHODS Subjects were recruited by letter of invitation to women aged 50 - 65 years from lists in general practice s local to the Charing Cross Hospital Lipid Clinic in West London . Their menopausal status was confirmed and they were r and omized to one of three treatment groups or acted as controls . They attended for three visits ; at baseline , HRT was initiated as oestrogen alone , oral or transdermal . At the 3-month visit , HRT with the progestagen , norethisterone , was given cyclically , continuously or transdermally until the final visit at 6 months . A separate group of women from the menopause clinic at Chelsea and Westminster Hospital were studied on oestrogen implant then on implanted oestrogen and testosterone . The outcome measures studied were the separate effects of the four regimes as compared with controls on lipoproteins , glucose , insulin , fibrinogen , factor VII and E-selectin , together with weight , waist : hip ratio and blood pressure . RESULTS The continuous combined oestrogen-progestagen therapy had similar effects on cardiovascular risk factors as oestrogen with cyclical progestagen . All regimes lowered low-density lipoprotein cholesterol , the oral route being more potent than the parenteral ; the effect of transdermal HRT was similar to the implant . Lp(a ) was reduced only with the oral route . Reductions in factor VII and E-selectin were observed in both the oral and transdermal routes . There was no increase in body mass index , waist : hip ratio , blood pressure or glucose and insulin levels with any of the HRT regimes used . Systolic blood pressure was reduced with the transdermal route . CONCLUSIONS This study supports the evidence that oestrogen-progestagen HRT , both oral and transdermal , although attenuating some of the benefit of oestrogen alone on fibrinogen and high-density lipoprotein , significantly reduces cardiovascular risk factors , which should diminish post-menopausal risk of coronary disease",
"The effect of estrogen and /or and rogen on mood in surgically menopausal women was investigated with a prospect i ve , double-blind , cross-over design . Oophorectomized women who received either estrogen ( E ) , and rogen ( A ) , or a combined estrogen- and rogen preparation ( E-A ) parenterally attained lower depression scores during both treatment phases compared to a placebo group ( PL ) , coincident with their higher plasma estrogen and testosterone levels . When steroids were withdrawn , depression scores of all oophorectomized women were significantly higher than those of a hysterectomized control group with intact ovaries ( CON ) . The A group also had higher hostility scores than the E , PL , and CON groups . These data provide evidence of a covariation between circulating levels of estrogen and testosterone and certain affects in healthy women",
"CONTEXT Observational studies have suggested that postmenopausal hormone treatment may improve cognitive function , but data from r and omized clinical trials have been sparse and inconclusive . The Women 's Health Initiative Memory Study ( WHIMS ) is an ancillary study of the Women 's Health Initiative ( WHI ) hormone therapy trials . On July 8 , 2002 , the estrogen plus progestin therapy in the WHI trial was discontinued because of certain increased health risks for women . OBJECTIVE To determine whether estrogen plus progestin therapy protects global cognitive function in older postmenopausal women . DESIGN , SETTING , AND PARTICIPANTS A r and omized , double-blind , placebo-controlled clinical trial , WHIMS is an ancillary study of geographically diverse , community-dwelling women aged 65 years or older from 39 of 40 clinical centers within the WHI estrogen plus progestin trial that started in June 1995 . Of 4894 eligible postmenopausal women aged 65 years or older and free of probable dementia at baseline , 4532 ( 92.6 % ) were enrolled in the estrogen plus progestin component of WHIMS . A total of 4381 participants ( 96.7 % ) provided at least 1 valid cognitive function score between June 1995 and July 8 , 2002 . INTERVENTIONS Participants received either 1 daily tablet containing 0.625 mg of conjugated equine estrogen with 2.5 mg of medroxyprogesterone acetate ( n = 2145 ) or matching placebo ( n = 2236 ) . MAIN OUTCOME MEASURE Global cognitive function measured annually with the Modified Mini-Mental State Examination . RESULTS The Modified Mini-Mental State Examination mean total scores in both groups increased slightly over time ( mean follow-up of 4.2 years ) . Women in the estrogen plus progestin group had smaller average increases in total scores compared with women receiving placebo ( P = .03 ) , but these differences were not clinical ly important . Removing women by censoring them after adjudicated dementia , mild cognitive impairment , or stroke , and nonadherence to study protocol , did not alter the findings . Prior hormone therapy use and duration of prior use did not affect the interpretation of the results , nor did timing of prior hormone therapy initiation with respect to the final menstrual period . More women in the estrogen plus progestin group had a substantial and clinical ly important decline ( > or = 2 SDs ) in Modified Mini-Mental State Examination total score ( 6.7 % ) compared with the placebo group ( 4.8 % ) ( P = .008 ) . CONCLUSIONS Among postmenopausal women aged 65 years or older , estrogen plus progestin did not improve cognitive function when compared with placebo . While most women receiving estrogen plus progestin did not experience clinical ly relevant adverse effects on cognition compared with placebo , a small increased risk of clinical ly meaningful cognitive decline occurred in the estrogen plus progestin group",
"We wished to investigate if a testosterone gel administered percutaneously to postmenopausal women could result in stable serum levels of the hormone and which dose was required to produce levels within the normal premenopausal range . Fifteen postmenopausal women , mean age 55.3 years ( range 45–70 years ) , volunteered to participate in the study and were divided into three groups . They received 10 , 20 or 30 mg of testosterone as a 1 % testosterone hydroalcoholic gel at 09.00 hours daily for 14 days . The gel was applied in a thin layer on the outside of the thigh each morning , over an area of approximately 15 cm2 . Blood sample s were collected hourly between 09.00 and 17.00 hours on days 1 and 14 , and also at 08.00 hours on days 3 , 5 , 11 , 12 , 13 and finally day 16 , i.e. 2 days after termination of treatment . The mean basal serum level of testosterone was 1.1 ± 0.9 nmol/l and for 5α-dihydrotestosterone 208 ± 143 pmol/l . There was a clear increase from the 10 mg to the 20 mg treatment ( mean testosterone level during treatment 3.2 and 7.2 nmol/l , respectively ) while serum testosterone values after 30 mg showed very little further increase ( mean 7.5 nmol/l ) . Values for days 3–5 were quite similar to those for days 13–14 . The present study suggests that adequate and acceptable serum levels of testosterone can be achieved with 10 mg testosterone applied transdermally",
" Summary . Forty postmenopausal women , referred for hormone replacement therapy and all of whom reported a significant concern about a decline in their sexual interest , were r and omly allocated to one of two hormone implant treatment groups : either oestradiol ( 50 mg ) alone , or oestradiol ( 50 mg ) and testosterone ( l00 mg ) . Comparison between the two groups as a whole revealed no significant differences on any measure , both treatments being associated with a significant reduction in the severity of psychological , somatic and vasomotor symptoms , and with a significant improvement in sexual interest and responsiveness . Similar effects were also observed in patients who denied , pretreatment , any concurrent dyspareunia . Although it is not possible to identify the reasons for change , the results indicate no advantages of supplementary testosterone administration over oestradiol alone for sexually unresponsive postmenopausal women",
"CONTEXT The Women 's Health Initiative ( WHI ) trial of estrogen plus progestin was stopped early because of adverse effects , including an increased risk of stroke in the estrogen plus progestin group . OBJECTIVE To assess the effect of estrogen plus progestin on ischemic and hemorrhagic stroke and in subgroups , and to determine whether the effect of estrogen plus progestin was modified by baseline levels of blood biomarkers . DESIGN Multicenter double-blind , placebo-controlled , r and omized clinical trial involving 16 608 women aged 50 through 79 years with an average follow-up of 5.6 years . Baseline levels of blood-based markers of inflammation , thrombosis , and lipid levels were measured in the first 140 central ly confirmed stroke cases and 513 controls . INTERVENTIONS Participants received 0.625 mg/d of conjugated equine estrogen plus 2.5 mg/d of medroxyprogesterone acetate ( n = 8506 ) or placebo ( n = 8102 ) . MAIN OUTCOME MEASURES Overall strokes and stroke subtype and severity were central ly adjudicated by stroke neurologists . RESULTS One hundred fifty-one patients ( 1.8 % ) in the estrogen plus progestin and 107 ( 1.3 % ) in the placebo groups had strokes . Overall 79.8 % of strokes were ischemic . For combined ischemic and hemorrhagic strokes , the intention-to-treat hazard ratio ( HR ) for estrogen plus progestin vs placebo was 1.31 ( 95 % confidence interval [ CI ] , 1.02 - 1.68 ) ; with adjustment for adherence , the HR was 1.50 ( 95 % CI , 1.08 - 2.08 ) . The HR for ischemic stroke was 1.44 ( 95 % CI , 1.09 - 1.90 ) and for hemorrhagic stroke , 0.82 ( 95 % CI , 0.43 - 1.56 ) . Point estimates of the HRs indicate that excess risk of all stroke was apparent in all age groups , in all categories of baseline stroke risk , and in women with and without hypertension , prior history of cardiovascular disease , use of hormones , statins , or aspirin . Other risk factors for stroke , including smoking , blood pressure , diabetes , lower use of vitamin C supplements , blood-based biomarkers of inflammation , higher white blood cell count , and higher hematocrit levels did not modify the effect of estrogen plus progestin on stroke risk . CONCLUSIONS Estrogen plus progestin increases the risk of ischemic stroke in generally healthy postmenopausal women . Excess risk for all strokes attributed to estrogen plus progestin appeared to be present in all subgroups of women examined",
"PURPOSE To determine whether systemic replacement with combined esterified estrogen ( EE ) and methyltestosterone ( MT ) ( EE + MT ) would reduce symptoms and promote clinical improvement in postmenopausal women with dry eye syndrome ( DES ) . DESIGN Retrospective , noncomparative , interventional case series . METHODS Investigators review ed the charts of 11 postmenopausal women treated within the last 3 years with EE + MT . RESULTS The mean patient age was 65.2 years ( st and ard deviation [ SD ] 11.4 , range 48 - 84 years ) . The mean treatment duration was 12.2 months ( SD 6.2 months , range 4 - 24 months ) . Ten ( 91 % ) of 11 patients reported improvement in dry eye symptoms while receiving treatment . For these 10 , relief occurred after an average of 4.1 months of treatment ( SD 3.2 , range , 1 - 9 months ) . CONCLUSIONS Treatment with EE + MT may be efficacious for DES of various etiologies . A r and omized placebo-controlled trial is planned to further evaluate these encouraging findings",
"Although the postmenopausal ovary remains an important source of testosterone ( T ) production , there is nevertheless a decline in total circulating and rogen levels with age . A role for and rogen replacement in addition to estrogens in some postmenopausal , particularly ovariectomized , women is increasingly gaining acceptance . We have compared the pharmacokinetics of two existing testosterone preparations , oral testosterone undecanoate ( TU ) and sc testosterone implants , with a new matrix transdermal delivery system for T. In study 1 , three different doses of TU ( 40 mg , two 20-mg doses 6 h apart and two 10-mg doses 6 h apart , orally ) were investigated in 10 postmenopausal women . Median peak levels of 18 nmol/L ( range , 5.8 - 64.0 nmol/L ; 40 mg ) , 12.3 nmol/L ( range , 5.7 - 29.2 nmol/L ; 20 mg ) , and 9.7 nmol/L ( range , 7.8 - 28.7 nmol/L ; 10 mg ) were observed , but T levels varied considerably within and between subjects regardless of the dose used . In study 2 , 30 women receiving s.c . estradiol therapy were r and omized to receive either a 100-mg T implant or placebo . In the T-treated group , levels peaked at 8.9 + /- 1.7 nmol/L 1 month after insertion and then declined gradually to 2.9 + /- 0.4 nmol/L at 6 months . In study 3 , a novel matrix transdermal delivery system for T was investigated in 6 females . Estimated daily delivery rates of 840 ( TD 1 ) , 1100 ( TD2 ) , and 3000 microg ( TD3 ) T/24 h were investigated . T rose rapidly after a single application of TD 1 and TD2 and were relatively constant for the next 18 h , at which time peaks of 2.3 + /- 1.0 and 4.1 + /- 1.6 nmol/L , respectively , at 24 h were seen . T concentrations fell to baseline levels within 6 h after patch removal . When TD2 was applied for 7 days , a T level of 4.3 + /- 0.7 nmol was seen 24 h after application , falling gradually to 2.8 + /- 0.7 nmol/L by day 7 . During twice weekly application of TD2 , stable T concentrations were maintained , and all peak levels were similar ( peak level , 4.2 + /- 0.3 nmol/L 24 h post-TD application ) as were predose troughs ( 3.2 + /- 0.3 nmol ) . Twice weekly application of TD3 produced a similar pattern of T , and the mean peak and trough levels were 7.5 + /- 0.9 and 4.0 + /- 0.4 nmol/L , respectively . In conclusion , TU produced inappropriate high T levels at all doses , with wide variations between subjects , confirming that TU is unpredictably absorbed and unlikely to be satisfactory for use in women . Subcutaneous testosterone implants produce unphysiological T levels for at least 1 - 2 months . The transdermal matrix delivery system maintained relatively stable T levels within narrow ranges with little within- and between-subject variation . We conclude that such transdermal systems may be of value for and rogen therapy in postmenopausal women because they provide a highly controllable way of delivering T noninvasively and reliably , and achieve mean physiological levels not possible with existing methods"
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4117fdf2-06ff-11f0-808a-c43d1ab1c353
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AIMS To establish whether irrigant activation techniques ( IATs ) result in greater intracanal smear layer and debris removal than conventional needle irrigation ( CNI ) . METHODOLOGY Six electronic data bases were search ed to identify scanning electron microscopy studies evaluating smear layer and /or debris removal following the use of manual dynamic activation ( MDA ) , passive ultrasonic irrigation ( PUI ) , sonic irrigation ( SI ) or apical negative pressure ( ANP ) IATs in mature permanent teeth . Meta-analyses were performed for each canal segment ( coronal , middle , apical and apical 1 mm ) in addition to subgroup analyses for individual IATs with respect to CNI . Outcomes were presented as st and ardized mean differences ( SMD ) alongside 95 % confidence intervals ( 95 % CI ) and chi-squared analysis . RESULTS From 252 citations , 16 studies were identified . The meta-analyses demonstrated significant improvements in coronal ( SMD : 1.15 , 95 % CI : 0.72 - 1.57 / SMD : 0.54 , 95 % CI : 0.29 - 0.80 ) , middle ( SMD : 1.30 , 95 % CI : 0.59 - 2.53 / SMD : 0.8 , 95 % CI : 0.58 - 1.13 ) and apical thirds ( SMD : 1.22 , 95 % CI : 0.83 - 1.62 / SMD : 1.86 , 95 % CI : 0.76 - 2.96 ) for smear layer and debris removal , respectively . In the apical 1 mm IATs improved cleanliness ; however , differences were insignificant ( SMD : 1.15 , 95 % CI : -0.47 - 2.77 ) . Chi-squared analysis revealed heterogeneity scores of 79.3 - 92.8 % and 0.0 - 93.5 % for smear layer and debris removal , respectively . CONCLUSIONS IATs improve intracanal cleanliness across a substantial portion of the canal , and therefore , their use is recommended throughout root canal preparation . However , current data is too heterogeneous to compare and identify superiority of an individual technique highlighting the need to st and ardize experimental protocol s and develop a more representative research model to investigate the in vivo impact of IATs on clinical outcomes and periapical healing following root canal treatment
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"The purpose of the present study is to evaluate smear layer generation and residual debris after using self-adjusting file ( SAF ) or rotary instrumentation and to compare the debris and smear layer removal efficacy of the SAF cleaning/shaping irrigation system against final agitation techniques . One hundred and eight maxillary lateral incisor teeth were r and omly divided into nine experimental groups ( n = 12 ) , and root canals were prepared using ProTaper Universal rotary files , with the exception of the SAF instrumentation group . During instrumentation , root canals were irrigated with a total of 16 mL of 5 % NaOCl . For final irrigation , rotary-instrumented groups were irrigated with 10 mL of 17 % EDTA and 10 mL of 5 % NaOCl using different irrigation agitation regimens ( syringe irrigation with needles , NaviTip FX , manual dynamic irrigation , CanalBrush , EndoActivator , EndoVac , passive ultrasonic irrigation ( PUI ) , and SAF irrigation ) . In the SAF instrumentation group , root canals were instrumented for 4 min at a rate of 4 mL/min with 5 % NaOCl and received a final flush with same as syringe irrigation with needles . The surface of the root dentin was observed using a scanning electron microscope . The SAF instrumentation group generated less smear layer and yielded cleaner canals compared to rotary instrumentation . The EndoActivator , EndoVac , PUI , and SAF irrigation groups increased the efficacy of irrigating solutions on the smear layer and debris removal . The SAF instrumentation yielded cleaner canal walls when compared to rotary instrumentation . None of the techniques completely removed the smear layer from the root canal walls",
"AIM To compare the smear layer and debris removal effectiveness of four root canal irrigation protocol s as well as their effectiveness in removing remaining soft tissues in curved root canals . METHODOLOGY The mesiobuccal and mesial root canals of 107 extracted human maxillary and m and ibular molars were instrumented using Mtwo rotary NiTi instruments then r and omly divided into four groups according to a final rinse protocol : Group 1 ( n = 28 ) - manual agitation of 1 % NaOCl and 15 % EDTA ; Group 2 ( n = 26 ) - CanalBrush agitation of 1 % NaOCl and 15 % EDTA ; Group 3 ( n = 26 ) - 3 % H(2 ) O(2 ) alternated with 1 % NaOCl ; Group 4 ( n = 27 ) - passive ultrasonic agitation of 1 % NaOCl and 15 % EDTA . All irrigation protocol s were performed in a closed system . Eleven roots per group were prepared and histologically stained ( H&E ) to assess percentage of remaining pulpal tissues in the apical thirds . The remaining specimens were split longitudinally and examined under scanning electron microscope at ×2000 magnification to assess smear layer and debris removal . Image Pro Plus 6.0 software was used to analyse smear layer and remaining pulp tissue . Debris presence was scored by two blinded investigators using a five-point scale . Data were analysed using Univariate analysis of variance ( GenStat 13 , α = 0.05 ) . RESULTS CanalBrush and passive ultrasonic irrigation were equally effective with significantly less smear layer and debris than manual agitation and H(2 ) O(2 ) alternated with NaOCl ( P with NaOCl protocol was significantly more effective in removing pulp tissue remnants in the apical level than manual agitation ( P = 0.009 ) and passive ultrasonic irrigation ( P = 0.01 ) . CONCLUSIONS CanalBrush was as effective as passive ultrasonic irrigation in smear layer and debris removal . Alternating H(2 ) O(2 ) with NaOCl was effective in removing soft tissues from root canal complexities . Further studies are required to evaluate effectiveness of this regimen taking into account irrigant volume differences and effect of root canal system configuration",
"AIM To compare the effect of passive ultrasonic irrigation with manual dynamic irrigation on smear layer removal from root canals using a closed apex in vitro model . METHODS The root canals of 45 freshly-extracted human single-rooted m and ibular premolar teeth were prepared by the Pro-Taper rotary system to an apical preparation of F4 size . Prepared teeth were r and omly divided into three groups ; two experimental groups and one control group ( n = 15 ) on the basis of the type of activation of final irrigation as follows : ( a ) Group A , 3 % sodium hypochlorite ( NaOCl ) and 17 % ethylenediaminetetraacetic acid ( EDTA ) , no activation received ; ( b ) Group B , 3 % NaOCl and 17 % EDTA , ultrasonic activation with a small file ; and ( c ) Group C , 3 % NaOCl and 17 % EDTA , manual activation with a master gutta-percha point . The prepared teeth were decoronated and split into two halves longitudinally , and observed under a scanning electron microscope to assess the removal of the smear layer . RESULTS In the apical-third region , the mean smear scores for groups B and C were significantly less than those of Group A ( control group ) ( P removing the smear layer , with manual dynamic activation being a simpler , safer , and more cost-effective technique",
"INTRODUCTION The aim of this study was to compare the outcome of a root canal treatment with and without additional ultrasonic activation of the irrigant . METHODS Single-rooted teeth with radiographic evidence of periapical bone loss were r and omly assigned to 2 treatment groups . In both groups syringe irrigation was performed , and in one group the irrigant was also activated by ultrasound . Ten to 19 months after treatment , the teeth were examined by using periapical radiography ( PA ) and cone-beam computed tomography ( CBCT ) . Area and volume of the periapical lesions were measured , and the outcome was presented in 4 categories : absence , reduction or enlargement of the radiolucency , or uncertain . Lesions were classified as reduced or enlarged when the change in size of the radiolucency was 20 % or more . RESULTS The recall rate was 82 % , and 84 teeth were analyzed . CBCT detected significantly more post-treatment lesions than PA ( P = .038 ) , but the percentages of absence and reduction of the radiolucency together revealed by CBCT and PA were similar ( P = .383 ) . The CBCT results showed that absence of the radiolucency was observed in 16 of 84 teeth ( 19 % ) and reduction of the radiolucency in 61 of 84 teeth ( 72.6 % ) , but there was no significant difference between the results of the 2 groups ( P = .470 ) . Absence and reduction of the radiolucency together were observed in the ultrasonic group in 39 of 41 teeth ( 95.1 % ) and in the syringe group in 38 of 43 teeth ( 88.4 % ) . CONCLUSIONS Root canal treatments with and without additional ultrasonic activation of the irrigant contributed equally to periapical healing",
"Background Root canal irrigation carries a risk of extrusion of irrigant into the periapical tissues which can be associated with pain , swelling , and tissue damage . Studies have shown less extrusion with sonic or apical negative pressure devices compared with syringe and side-port needle or passive ultrasonic irrigation with continuous irrigant flow . This study aim ed to evaluate the effectiveness of the EndoVac irrigation system , regarding 1 ) debris removal and 2 ) the control of apically extruded irrigating solution . Methods Fifty extracted human single-rooted teeth were used in this study . The teeth were then r and omly divided into three experimental groups according to the type of irrigation used and one control group . In group 1 , irrigation was performed using the EndoVac irrigation system . In group 2 , irrigation was performed using a 30-gauge , tip-vented irrigation needle . In group 3 , irrigation was performed using a 30-gauge , side-vented irrigation needle . The control group received instrumentation with no irrigation to serve as a control for cleaning efficiency . Root canal instrumentation was performed using the Profile NiTi rotary system with a crown-down technique . All of the experimental teeth were irrigated with the same amount of 5.25 % sodium hypochlorite . The amount of extruded irrigating solution was then measured by subtracting the post-instrumentation weight from the pre-instrumentation weight using an electronic balance . The cleanliness of debris removal was evaluated using scanning electron microscopy . Results EndoVac irrigation had the least amount of extrusion followed by the side-vented and tip-vented method . The difference between the groups was statistically significant ( P debris collection in the EndoVac and tip-vented groups was the least in the apical third . In the control and the side-vented groups , the debris was the greatest in the apical third , but this difference was not significant among the three experimental groups . Conclusions The EndoVac irrigation system extruded significantly less irrigant solution than either needle irrigation system . Debris collection was the least in the apical third for the EndoVac irrigation system . No significant difference was found in the cleaning efficiency among the three irrigation systems",
"Background Efforts to improve the efficacy of smear layer removal by applying irrigant activation at the final irrigation or by elevating the temperature of the irrigant have been reported . However , the combination of such activation protocol s with 60 ° C 3 % sodium hypochlorite ( NaOCl ) has seldom been mentioned . The aim of this study was to compare the efficacy in smear layer removal of four different irrigation techniques combined with 60 ° C 3 % NaOCl and 17 % EDTA . Methods Fifty single-rooted teeth were r and omly divided into five groups ( n = 10 ) according to the irrigant agitation protocol s used during chemomechanical preparation(Dentsply Maillefer , Ballaigues , Switzerl and ): a side-vented needle group , a ultrasonic irrigation ( UI ) group , a NaviTip FX group , an EndoActivator group , and a control group ( no agitation ) . After each instrumentation , the root canals were irrigated with 1 mL of 3 % NaOCl at 60 ° C for 1 minute , and after the whole instrumentation , the root canals were rinsed with 1 mL of 17 % EDTA for 1 minute . Both NaOCl and EDTA were activated with one of the five irrigation protocol s. The efficacy of smear layer removal was scored at the apical , middle and coronal thirds . The Data were statistically analyzed using SAS version 9.2 for Windows ( rank sum test for a r and omised block design and ANOVA ) . Results No significant differences among the NaviTip FX group , EndoActivator group and control groups , and each of these groups showed a lower score than that of UI group ( P middle > apical ( P the NaviTip FX group was better than UI group . In the middle and apical third , the differences were not significant among any of the groups . Conclusions Even without any activation , the combination of 60 ° C 3 % NaOCl and 17 % EDTA could remove the smear layer effectively , similar to NaviTip FX or EndoActivator , and these three protocol s were more effective than UI . However , regardless of different types of irrigation technique applied , complete removal of the smear layer was not achieved , particularly in the apical third",
"AIM To compare the cleaning effectiveness of chamomile hydroalcoholic extract and tea tree oil to 2.5 % sodium hypochlorite ( NaOCl ) solution as an intracanal irrigant for the removal of the smear layer . METHODOLOGY Forty extracted , single-rooted , mature , permanent , human teeth were allocated at r and om into one of three experimental groups of ten teeth and two control groups of five teeth . For each tooth , the pulp chamber was accessed and the canal prepared using K-type files and Gates-Glidden burs , using a step-back technique ; the apical stop was prepared to a size 30 . Each canal was subsequently irrigated with one of the following solutions : distilled water ( as a negative control ) , 2.5 % NaOCl + 17 % ethylenediamine tetraacetic acid ( EDTA ) ( as a positive control ) , chamomile or tea tree oil or 2.5 % NaOCl . Each tooth was split longitudinally and prepared for examination by scanning electron microscopy ( SEM ) . The quantity of smear layer remaining on the three levels of each canal ( coronal , middle and apical ) was examined using magnifications of 2000 and 5000x . The data were analysed using nonparametric Kruskal-Wallis and Mann-Whitney U-tests . RESULTS The most effective removal of smear layer occurred with the use of NaOCl with a final rinse of 17 % EDTA ( negative control ) followed by the use of a chamomile extract . Chamomile extract was found to be significantly more effective than distilled water and tea tree oil ( P NaOCl solution alone , without EDTA and that of tea tree oil , was found to have only minor effects . There was no statistical difference between distilled water , 2.5 % NaOCl and tea tree oil . CONCLUSIONS The efficacy of chamomile to remove smear layer was superior to NaOCl alone but less than NaOCl combined with EDTA",
"OBJECTIVE The objective of this study was to evaluate smear layer removal after using the new CanalBrush ( Coltene/Whaledent GmbH+Co . KG , Germany ) . STUDY DESIGN Twenty extracted maxillary anterior teeth were r and omly divided into 2 equal groups . The canals of the teeth in each group were instrumented with ProTaper Universal rotary files ( Dentsply Maillefer , Switzerl and ) . Following each file use , the root canals in both groups were irrigated with 5.25 % NaOCl and 15 % EDTA . At the end of instrumentation , the canals in group 2 were flushed with 15 % EDTA , then a CanalBrush was used for 30 seconds , and a final irrigation was conducted with 5.25 % NaOCl . All teeth were processed for scanning electron microscopy ( SEM ) , and the removal of the smear layer was examined in the apical , middle , and coronal thirds . Analyses of SEM images were performed by 2 independent evaluators in a blinded manner and using a 4-point scoring system . RESULTS The middle and apical thirds of the root canals in group 2 showed lower average scores than those in group 1 , but the difference was not statistically significant . There was no significant difference in the coronal score between the groups ( P > .05 ) . CONCLUSIONS Irrigating with brushing tended to produce cleaner canal walls , but irrigating brushing was not significantly better than irrigation alone in removing the smear layer on the canal walls",
"INTRODUCTION The purpose of this investigation was to determine the effect that apical preparation size and preparation taper have on the volume of irrigant delivered at the working length for different canal curvatures using apical negative pressure irrigation . METHODS One hundred fifty-five human teeth ( 55 maxillary canines and 100 m and ibular molars ) were used in this study . Root canals were prepared with rotary instruments to a size 35.04 and separated into 3 experimental groups according to their degree of curvature : group A ( n = 50 ) included canal curvatures ranging from 0 ° to 10 ° , group B ( n = 50 ) from 11 ° to 30 ° , and group C ( n = 50 ) from 31 ° to 65 ° . Sample s of each curvature group were further r and omized to experimental subgroups according to the apical size and taper as follow : 35.06 , 40.04 , 40.06 , 45.04 , and 45.06 . The apical third was irrigated using a microcannula and the volume of NaOCl suctioned at the working length under negative pressure was measured over a period of 30 seconds using a fluid recovery trap . Positive controls consisted of measuring the maximum volume of 5.25 % NaOCl capable of being suctioned by the microcannula from an open glass vial over 30 seconds . Negative control was the volume of irrigant aspirated by the microcannula with a preparation size of 25.04 over 30 seconds . RESULTS The volume of irrigant was significantly greater when the apical preparation size increased from 35.06 to 40.04 . As the apical preparation taper increased further from 40.04 to 40.06 , the volume of irrigant significantly improved in group B , but it was not significant in group A. Apical preparation sizes greater than 40.06 did not show an increase of the volume of irrigant aspirated . CONCLUSIONS The degree of root canal curvature decreased the volume of irrigant at the working length for a given apical size and taper . An apical preparation of 40.06 significantly increased the volume and exchange of irrigant at the working length regardless of curvature",
"The usefulness of NaviTip FX , a brush-covered irrigation needle , in endodontic therapy has never been reported . Therefore , the purpose of this investigation was to evaluate the cleaning efficacy of this new brush-covered irrigation needle , the NaviTip FX . Thirty single-rooted teeth were r and omly divided into two equal groups and instrumented using the crown-down technique with 0.04 taper ProFile . Following each file use , the canals were irrigated with 1 ml of 5.25 % NaOCl using the NaviTip FX needle for group 1 or using the same needle without the brush for group 2 . At the end of instrumentation , the roots were cut longitudinally and each half was divided into three equal parts . The specimens were then routinely prepared for scanning electron microscopic evaluation . The results showed that using the NaviTip FX produced cleaner coronal thirds of instrumented root canals compared to the control group . On the other h and , the middle and apical thirds were not statistically significantly different between the two groups . Further development of this irrigation technique to improve cleanliness of the apical and middle thirds is required before the NaviTip FX can be recommended for routine use during root canal therapy",
"Aim : The aim of this study was to compare smear layer removal at apical 1 mm level after final irrigation activation with an EndoVac system and Max-I probe . Material s and Methods : Fifty freshly extracted maxillary central incisors were r and omly divided into two groups after completing cleaning and shaping with ProTaper rotary files . In one group , final irrigation was performed with an EndoVac system while in the other group final irrigation was performed with a 30 gauge Max-I probe . 3 % sodium hypochlorite and 17 % ethylenediaminetetracetic acid were used as final irrigants in all teeth . After instrumentation and irrigation , the teeth were sectioned longitudinally into buccal and palatal halves and viewed under a scanning electron microscope for evaluation of the smear layer . Statistical analysis was performed using the Kruskal Wallis and Mann-Whitney U tests . Results : The EndoVac group showed significantly better smear layer removal compared with the Max-I probe at the apical 1 mm level . Conclusion : An apical negative pressure system ( EndoVac ) results in better debridement at apical 1 mm when compared with side-vented closed ended needle irrigation ( Max-I probe )",
"AIM To assess the ability of sodium hypochlorite ( NaOCl ) to penetrate simulated lateral canals and to reach working length ( WL ) when using the self-adjusting file ( SAF ) . METHODOLOGY Seventy single-rooted teeth with oval-shaped canals were used . Upon access , presence of a single canal was confirmed by direct visualization under a dental-operating microscope . Canal length and patency were obtained using a size 10 K-file and root length st and ardized to 18 mm . Pre-enlargement was restricted to the coronal one-third . The apical size of each canal was gauged at WL and sample s larger than size 30 were excluded . Canals were instrumented for 5 min using the SAF system while delivering a total of 20 mL of 5.25 % NaOCl and 5 mL of 17 % EDTA . Then , the apical diameters were st and ardized to size 35 using h and files . Four hundred and twenty simulated lateral canals were then created during the clearing process and roots coated with wax to create a closed system . All sample s were then cleared and r and omly assigned to four experimental groups : 1 ( n = 15 ) positive pressure ; 2 ( n = 15 ) SAF without pecking motion ; 3 ( n = 15 ) SAF with pecking motion ; 4 ( n = 15 ) apical negative pressure ( ANP ) irrigation and ( n = 10 ) control groups . Sample s were scored on the basis of the ability of the contrast solution to reach WL and permeate into the simulated lateral canals to at least 50 % of the total length . The Kruskal-Wallis test was used to analyse irrigant penetration and the Tukey test to determine statistical differences between groups ( P irrigant penetration to WL ( Table 1 ) . The differences between group 4 ( ANP ) and all other groups were significant in penetration to WL ( P penetration of the irrigant when using the SAF system but failed to irrigate at WL . None of the experimental groups demonstrated predictable irrigation of simulated lateral canals . CONCLUSIONS In this laboratory model , ANP was the only delivery system capable of irrigating consistently to full WL . None of the systems tested produced complete irrigation in artificial lateral canals",
"INTRODUCTION Many in vitro studies have debated over the ability of different irrigant delivery and /or agitation systems to reach the apical third of curved root canals ; however , little is known about irrigant penetration in vivo . Therefore , the purpose of this study was to compare the efficacy of the conventional endodontic irrigation needle , passive ultrasonic irrigation ( PUI ) , and a negative pressure system for irrigant delivery to working length ( WL ) of mesial canals of m and ibular molars . METHODS Thirty mesial canals of 30 vital m and ibular first or second molars were r and omly assigned into 3 groups ( n = 10 ) : ( 1 ) Monoject syringe with 27-gauge needle ; ( 2 ) PUI with IrriSafe tip ; and ( 3 ) EndoVac system . All canals were treated following the same preparation protocol to size 35/0.04 by using 5.25 % NaOCl as irrigant during preparation procedure . Before obturation , canals were irrigated with 1 mL of a radiopaque solution by using the assigned irrigation system , and a digital radiograph was taken by using a parallel technique . With the aid of image editing software the distance between WL and maximum irrigant penetration was measured . RESULTS Mean distances for Monoject , PUI , and EndoVac groups were 1.51 mm , 0.21 mm , and 0.42 mm , respectively . Analysis of variance test showed statistically significant differences between groups ( P Tukey honestly significant difference test showed statistically significant differences between the Monoject group and the other 2 groups ( P irrigant to WL of root canals",
"AIM The effects of three endodontic irrigants and two types of laser on a smear layer created by h and instrumentation were evaluated in vitro in the middle and apical thirds of root canals . METHODOLOGY Sixty human mature extracted m and ibular premolar teeth with a single root canal and a closed apex were distributed r and omly into five groups of 12 teeth each . Whilst cleaning and shaping up to a size 60 master apical file with a step-back technique , the root canals were irrigated with 3 mL of 5.25 % NaOCL and 3 % H2O2 , alternately , between each file size . Group 1 ( G1 ) were control specimens that were irrigated with a final flush of 17 % EDTA . The teeth in group 2 ( G2 ) were irrigated with a final flush of 6 % phosphoric acid , and group 3 ( G3 ) with 6 % citric acid . In the specimens of group 4 ( G4 ) the root canals were irradiated with a carbon dioxide ( CO2 ) laser , and specimens of group 5 ( G5 ) were irradiated using an Er : YAG laser . The teeth were split longitudinally and prepared for examination by scanning electron microscopy . RESULTS Control specimens ( G1 ) showed clean root-canal walls with open dentinal tubules in the middle one-third , but in some specimens thick smear layer was observed in the apical one-third . Specimens irrigated with a final flush of 6 % phosphoric acid ( G2 ) or 6 % citric acid ( G3 ) were cleaner than with 17 % EDTA , showing very clean root canal surfaces in the middle one-third but in the apical one-third the smear layer was not completely removed , especially at the openings of the dentinal tubules . The specimens irradiated with the CO2 laser ( G4 ) showed clean root-canal walls with the smear layer absent , charred , melted , recrystallized and glazed in both middle and apical thirds . The root-canal walls of the specimens irradiated with the Er : YAG laser ( G5 ) revealed an absent smear layer with open dentinal tubules in the middle and apical thirds . Statistical analysis showed no significant difference in the cleanliness of root-canal wall between G1 and G2 , and G1 and G3 . However , there were statistically significant differences ( P cleanliness of the middle and apical one-thirds of the root canals . CONCLUSIONS Irrigation with 17 % EDTA , 6 % phosphoric acid and 6 % citric acid did not remove all the smear layer from the root-canal system . In addition , these acidic solutions demineralized the interbular dentine around tabular openings , which became enlarged . The CO2 laser was useful in removing and melting the smear layer on the instrumented root-canal walls and the Er : YAG laser was the most effective in removing the smear layer from the root-canal wall",
"OBJECTIVE The aim of this study was to compare the effect of continuous , intermittent passive ultrasonic irrigation ( PUI ) and active scrubbing of irrigants with NaviTip FX ( Ultradent , South Jordan , UT ) in removing smear layer . STUDY DESIGN Forty single-rooted teeth were r and omly divided into 5 test groups and subjected to final irrigation with 17 % EDTA followed by 2.5 % NaOCl for 1 minute each using different activation methods : no activation ( control ) , brushing with NaviTip FX , continuous PUI with irrigant delivered at pulp chamber , continuous PUI with irrigant delivered through the ultrasonic unit , and intermittent PUI . Specimens were examined under scanning electron microscope , and the data were analyzed using Friedman 2-way analysis of variance , Kruskal-Wallis , and Mann-Whitney U tests . RESULTS NaviTip FX and intermittent PUI showed significantly lower smear score than other groups at the 3 mm level ( P intermittent ultrasonic activation were effective in the removal of smear layer from the apical third",
"AIM To evaluate the effect of an apical negative pressure system , a passive ultrasonic irrigation system and a combination of both apical negative pressure and passive ultrasonic irrigation on the penetration of the irrigating contrast solution ( ICS ) up to working length and into simulated lateral canals . METHODOLOGY The root canals of 64 single-rooted teeth were instrumented using the ProTaper rotary system . In each sample , three simulated lateral canals were created at 2 , 4 and 6 mm levels from the root apex using a 06-size C+ file ( Dentsply Maillefer , Ballaigues , Switzerl and ) . Sample s were r and omly assigned into 4 experimental groups ( n = 16 ) : group I - conventional needle irrigation , group II - passive ultrasonic irrigation , group III - apical negative irrigation system and group IV - combination of passive ultrasonic irrigation and apical negative pressure irrigation system . To examine irrigating solution penetration , Indian ink was mixed with 5.25 % NaOCl and delivered into the root canals . Sample s were then assessed by direct observation of the images taken using Canon EOS rebel T3 . The depth of penetration of ICS up to the working length and into the simulated lateral canals was analysed using chi-squared tests . RESULTS The combination ( ANP and PUI ) and ANP group had significantly deeper ICS penetration up to the working length ( P combination ( ANP and PUI ) and the PUI group exhibited significantly greater ICS penetration into lateral canals at the 6 mm level ( P combination of ANP and PUI had significantly greater ICS penetration into the lateral canals than the other groups ( P combination of ANP and PUI was the only group able to achieve irrigating contrast solution penetration both up to the working length and into lateral canals",
"AIM To compare the efficacy of three irrigation protocol s using an established ex vivo bio-molecular film model . METHODOLOGY Thirty human teeth with single straight canals were r and omly allocated to three groups [ static , manual-dynamic , automated-dynamic ( RinsEndo ] ; each with a sub-group ( n = 5 ) for needle position at 4 or 10 mm short of the working length ( WL ) . The root canals were prepared to apical size 40 , taper 0.08 . The teeth were split longitudinally into two halves and a st and ard coat of stained-collagen was applied to the canal surfaces . The re-assembled teeth were irrigated using one of the protocol s with the irrigation needle at one of two positions . Digital images of the canal surfaces , before and after irrigation with 18 mL of 2.5 % NaOCl , were used to score surface coverage with stained-collagen using image-analyses ( ipWin4 ) . The data were analysed using linear regression models . RESULTS The canal area covered with stained-collagen was significantly ( P dynamic irrigation ( manual/automated ) compared with static irrigation ; but automated-dynamic irrigation was significantly ( P = 0.037 ) less effective than manual-dynamic irrigation . The ' orientation of needle port ' , ' corono-apical level of canal ' and ' apical extent of needle placement ' were significant ( P efficacy of irrigation . Residual collagen was most evident in the coronal third . Deeper penetration of the needle tip result ed in significantly ( P collagen removal . CONCLUSIONS Automated-dynamic irrigation was significantly more effective ( 16 % ) than static irrigation but significantly less effective ( 5 % ) than manual-dynamic irrigation . Irrigation was more effective ( 7 % ) when the needle was placed closer to WL",
"INTRODUCTION The shaping ability of root canal instruments is determined by a complex interrelationship of parameters such as cross-sectional design and the ability to remove debris and the smear layer . The self-adjusting file ( SAF ) consists of a hollow , flexible instrument in the form of a compressible , thin-walled , pointed cylinder . The aim of this study was to compare the SAF with the ProTaper rotary file system , evaluating debris and smear layer removal and the presence of bacteria by using microbiological and scanning electron microscopy ( SEM ) evaluation . METHODS Fifty maxillary premolars were inoculated with Enterococcus faecalis for 30 days and then r and omly distributed into 2 groups . Group 1 was prepared with ProTaper rotary instruments and irrigated with 30-gauge side-vented needles . Group 2 was prepared by using the SAF system with continuous irrigation . Bacteriologic sample s were taken before and after preparation . All sample s were then longitudinally split and analyzed under scanning electron microscopy . The scoring was carried out by 3 blinded evaluators . RESULTS In group 1 , 40 % of sample s had negative cultures with postinstrumentation sample s taken with paper points ( S2a ) and 45 % with postinstrumentation dentin sample s ( S2b ) . In group 2 , 20 % of sample s had negative cultures with S2a and 15 % with S2b . Intragroup analyses evaluating the reduction in the number of colony-forming units ( CFUs ) from S1 to S2a and S2b demonstrated both preparation techniques were highly effective ( P CFUs was observed when comparing S2a and S2b in group 1 ( P CFUs at S2a and S2b ( P SEM scores were consistent with the microbiology findings . CONCLUSIONS The SAF system does not allow control of the apical enlargement , thus limiting the ability of the irrigants to achieve effective and predictable disinfection"
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Background The evidence showing the ill health effects of prolonged sedentary behaviour ( SB ) is growing . Most studies of SB in older adults have relied on self-report measures of SB . However , SB is difficult for older adults to recall and objective measures that combine accelerometry with inclinometry are now available for more accurately assessing SB . The aim of this systematic review was to assess the validity and reliability of these accelerometers for the assessment of SB in older adults . Methods EMBASE , PubMed and EBSCOhost data bases were search ed for articles published up to December 13 , 2017 . Articles were eligible if they : a ) described reliability , calibration or validation studies of SB measurement in healthy , community-dwelling individuals , b ) were published in English , Portuguese or Spanish , and c ) were published or in press as journal articles in peer- review ed journals . Results The review identified 15 studies in 17 papers . Of the included studies , 11 assessed the ActiGraph accelerometer . Of these , three examined reliability only , seven ( in eight papers ) examined validity only and one ( in two papers ) examined both . The strongest evidence from the studies review ed is from studies that assessed the validity of the ActiGraph . These studies indicate that analysis of the data using 60-s epochs and a vertical magnitude cut-point estimates of SB . Non-wear algorithms of 90 + consecutive zeros is also suggested for the ActiGraph . Conclusions Few studies have examined the reliability and validity of accelerometers for measuring SB in older adults . Studies to date suggest that the criteria research ers use for classifying an epoch as sedentary instead of as non-wear time ( e.g. , the non-wear algorithm used ) may need to be different for older adults than for younger adults . The required number of hours and days of wear for valid estimates of SB in older adults was not clear from studies to date . More older-adult-specific validation studies of accelerometers are needed , to inform future guidelines on the appropriate criteria to use for analysis of data from different accelerometer br and s . Trial registration PROSPERO ID # CRD42017080754 registered December 12 , 2017
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"In clinical measurement comparison of a new measurement technique with an established one is often needed to see whether they agree sufficiently for the new to replace the old . Such investigations are often analysed inappropriately , notably by using correlation coefficients . The use of correlation is misleading . An alternative approach , based on graphical techniques and simple calculations , is described , together with the relation between this analysis and the assessment of repeatability",
"INTRODUCTION Accelerometers are used increasingly in large epidemiologic studies , but , given logistic and cost constraints , most studies are restricted to a single , 7-day accelerometer monitoring period . It is unknown how well a 7-day accelerometer monitoring period estimates longer-term patterns of behavior , which is critical for interpreting , and potentially improving , disease risk estimates in etiologic studies . METHODS A subset of participants from the Women 's Health Study ( N=209 ; mean age , 70.6 [ SD=5.7 ] years ) completed at least two 7-day accelerometer administrations ( ActiGraph GT3X+ ) within a period of 2 - 3 years . Monitor output was translated into total counts , steps , and time spent in sedentary , light-intensity , and moderate to vigorous-intensity activity ( MVPA ) and bouted-MVPA ( i.e. , 10-minute bouts ) . For each metric , intraclass correlations ( ICCs ) and 95 % CIs were calculated using linear-mixed models and adjusted for wear time , age , BMI , and season . The data were collected in 2011 - 2015 and analyzed in 2015 - 2016 . RESULTS The ICCs ranged from 0.67 ( 95 % CI=0.60 , 0.73 ) for bouted-MVPA to 0.82 ( 95 % CI=0.77 , 0.85 ) for total daily counts and were similar across age , BMI , and for less and more active women . For all metrics , classification accuracy within 1 quartile was > 90 % . CONCLUSIONS These data provide reassurance that a 7-day accelerometer- assessment protocol provides a reproducible ( and practical ) measure of physical activity and sedentary time . However , ICCs varied by metric ; therefore , future prospect i ve studies of chronic diseases might benefit from existing methods to adjust risk estimates for within-person variability in activity to get a better estimate of the true strength of association",
"Background Accelerometers objective ly assess physical activity ( PA ) and are currently used in several large-scale epidemiological studies , but there is no consensus for processing the data . This study compared the impact of wear-time assessment methods and using either vertical (V)-axis or vector magnitude ( VM ) cut-points on accelerometer output . Methods Participants ( 7,650 women , mean age 71.4 y ) were mailed an accelerometer ( ActiGraph GT3X+ ) , instructed to wear it for 7 days , record date s and times the monitor was worn on a log , and return the monitor and log via mail . Data were processed using three wear-time methods ( logs , Troiano or Choi algorithms ) and V-axis or VM cut-points . Results Using algorithms alone result ed in \" mail-days \" incorrectly identified as \" wear-days \" ( 27 - 79 % of subjects had > 7-days of valid data ) . Using only date s from the log and the Choi algorithm yielded : 1 ) larger sample s with valid data than using log date s and times , 2 ) similar wear-times as using log date s and times , 3 ) more wear-time ( V , 48.1 min more ; VM , 29.5 min more ) than only log date s and Troiano algorithm . Wear-time algorithm impacted sedentary time ( ~30 - 60 min lower for Troiano vs. Choi ) but not moderate-to-vigorous ( MV ) PA time . Using V-axis cut-points yielded ~60 min more sedentary time and ~10 min less MVPA time than using VM cut-points . Conclusions Combining log- date s and the Choi algorithm was optimal , minimizing missing data and research er burden . Estimates of time in physical activity and sedentary behavior are not directly comparable between V-axis and VM cut-points . These findings will inform consensus development for accelerometer data processing in ongoing epidemiologic studies",
"OBJECTIVES Wrist-worn accelerometers are convenient to wear and associated with greater wear-time compliance . Previous work has generally relied on choreographed activity trials to train and test classification models . However , validity in free-living context s is starting to emerge . Study aims were : ( 1 ) train and test a r and om forest activity classifier for wrist accelerometer data ; and ( 2 ) determine if models trained on laboratory data perform well under free-living conditions . DESIGN Twenty-one participants ( mean age=27.6±6.2 ) completed seven lab-based activity trials and a 24h free-living trial ( N=16 ) . METHODS Participants wore a GENEActiv monitor on the non-dominant wrist . Classification models recognising four activity classes ( sedentary , stationary+ , walking , and running ) were trained using time and frequency domain features extracted from 10-s non-overlapping windows . Model performance was evaluated using leave-one-out-cross-validation . Models were implemented using the r and omForest package within R. Classifier accuracy during the 24h free living trial was evaluated by calculating agreement with concurrently worn activPAL monitors . RESULTS Overall classification accuracy for the r and om forest algorithm was 92.7 % . Recognition accuracy for sedentary , stationary+ , walking , and running was 80.1 % , 95.7 % , 91.7 % , and 93.7 % , respectively for the laboratory protocol . Agreement with the activPAL data ( stepping vs. non-stepping ) during the 24h free-living trial was excellent and , on average , exceeded 90 % . The ICC for stepping time was 0.92 ( 95 % CI=0.75 - 0.97 ) . However , sensitivity and positive predictive values were modest . Mean bias was 10.3min/d ( 95 % LOA=-46.0 to 25.4min/d ) . CONCLUSIONS The r and om forest classifier for wrist accelerometer data yielded accurate group-level predictions under controlled conditions , but was less accurate at identifying stepping verse non-stepping behaviour in free living conditions Future studies should conduct more rigorous field-based evaluations using observation as a criterion measure",
"Background Studies of mid-aged adults provide evidence of a relationship between sitting-time and all-cause mortality , but evidence in older adults is limited . The aim is to examine the relationship between total sitting-time and all-cause mortality in older women . Methods The prospect i ve cohort design involved 6656 participants in the Australian Longitudinal Study on Women 's Health who were followed for up to 9 years ( 2002 , age 76–81 , to 2011 , age 85–90 ) . Self-reported total sitting-time was linked to all-cause mortality data from the National Death Index from 2002 to 2011 . Cox proportional hazard models were used to examine the relationship between sitting-time and all-cause mortality , with adjustment for potential sociodemographic , behavioural and health confounders . Results There were 2003 ( 30.1 % ) deaths during a median follow-up of 6 years . Compared with participants who sat risk of death and those who sat ≥11 h/day had a 1.65 times higher risk of death . These risks remained after adding sociodemographic and behavioural covariates , but were attenuated after adjustment for health covariates . A significant interaction ( p=0.02 ) was found between sitting-time and physical activity ( PA ) , with increased mortality risk for prolonged sitting only among participants not meeting PA guidelines ( HR for sitting ≥8 h/day : 1.31 , 95 % CI 1.07 to 1.61 ) ; HR for sitting ≥11 h/day : 1.47 , CI 1.15 to 1.93 ) . Conclusions Prolonged sitting-time was positively associated with all-cause mortality . Women who reported sitting for more than 8 h/day and did not meet PA guidelines had an increased risk of dying within the next 9 years",
"PURPOSE The objective of this study is to compare activity type classification rates of machine learning algorithms trained on laboratory versus free-living accelerometer data in older adults . METHODS Thirty-five older adults ( 21 females and 14 males , 70.8 ± 4.9 yr ) performed selected activities in the laboratory while wearing three ActiGraph GT3X+ activity monitors ( in the dominant hip , wrist , and ankle ; ActiGraph , LLC , Pensacola , FL ) . Monitors were initialized to collect raw acceleration data at a sampling rate of 80 Hz . Fifteen of the participants also wore GT3X+ in free-living setting s and were directly observed for 2 - 3 h. Time- and frequency-domain features from acceleration signals of each monitor were used to train r and om forest ( RF ) and support vector machine ( SVM ) models to classify five activity types : sedentary , st and ing , household , locomotion , and recreational activities . All algorithms were trained on laboratory data ( RFLab and SVMLab ) and free-living data ( RFFL and SVMFL ) using 20-s signal sampling windows . Classification accuracy rates of both types of algorithms were tested on free-living data using a leave-one-out technique . RESULTS Overall classification accuracy rates for the algorithms developed from laboratory data were between 49 % ( wrist ) and 55 % ( ankle ) for the SVMLab algorithms and 49 % ( wrist ) to 54 % ( ankle ) for the RFLab algorithms . The classification accuracy rates for SVMFL and RFFL algorithms ranged from 58 % ( wrist ) to 69 % ( ankle ) and from 61 % ( wrist ) to 67 % ( ankle ) , respectively . CONCLUSIONS Our algorithms developed on free-living accelerometer data were more accurate in classifying the activity type in free-living older adults than those on our algorithms developed on laboratory accelerometer data . Future studies should consider using free-living accelerometer data to train machine learning algorithms in older adults",
"UNLABELLED The absence of comparative validity studies has prevented research ers from reaching consensus regarding the application of intensity-related accelerometer cut points for children and adolescents . PURPOSE This study aim ed to evaluate the classification accuracy of five sets of independently developed ActiGraph cut points using energy expenditure , measured by indirect calorimetry , as a criterion reference st and ard . METHODS A total of 206 participants between the ages of 5 and 15 yr completed 12 st and ardized activity trials . Trials consisted of sedentary activities ( lying down , writing , computer game ) , lifestyle activities ( sweeping , laundry , throw and catch , aerobics , basketball ) , and ambulatory activities ( comfortable walk , brisk walk , brisk treadmill walk , running ) . During each trial , participants wore an ActiGraph GT1 M , and V˙O2 was measured breath-by-breath using the Oxycon Mobile portable metabolic system . Physical activity intensity was estimated using five independently developed cut points : Freedson/Trost ( FT ) , Puyau ( PU ) , Treuth ( TR ) , Mattocks ( MT ) , and Evenson ( EV ) . Classification accuracy was evaluated via weighted κ statistics and area under the receiver operating characteristic curve ( ROC-AUC ) . RESULTS Across all four intensity levels , the EV ( κ=0.68 ) and FT ( κ=0.66 ) cut points exhibited significantly better agreement than TR ( κ=0.62 ) , MT ( κ=0.54 ) , and PU ( κ=0.36 ) . The EV and FT cut points exhibited significantly better classification accuracy for moderate- to vigorous-intensity physical activity ( ROC-AUC=0.90 ) than TR , PU , or MT cut points ( ROC-AUC=0.77 - 0.85 ) . Only the EV cut points provided acceptable classification accuracy for all four levels of physical activity intensity and performed well among children of all ages . The widely applied sedentary cut point of 100 counts per minute exhibited excellent classification accuracy ( ROC-AUC=0.90 ) . CONCLUSIONS On the basis of these findings , we recommend that research ers use the EV ActiGraph cut points to estimate time spent in sedentary , light- , moderate- , and vigorous-intensity activity in children and adolescents",
"Accurate monitoring of sedentary behaviour and physical activity is key to investigate their exact role in healthy ageing . To date , accelerometers using cut-off point models are most preferred for this , however , machine learning seems a highly promising future alternative . Hence , the current study compared between cut-off point and machine learning algorithms , for optimal quantification of sedentary behaviour and physical activity intensities in the elderly . Thus , in a heterogeneous sample of forty participants ( aged ≥60 years , 50 % female ) energy expenditure during laboratory-based activities ( ranging from sedentary behaviour through to moderate-to-vigorous physical activity ) was estimated by indirect calorimetry , whilst wearing triaxial thigh-mounted accelerometers . Three cut-off point algorithms and a R and om Forest machine learning model were developed and cross-vali date d using the collected data . Detailed analyses were performed to check algorithm robustness , and examine and benchmark both overall and participant-specific balanced accuracies . This revealed that the four models can at least be used to confidently monitor sedentary behaviour and moderate-to-vigorous physical activity . Nevertheless , the machine learning algorithm outperformed the cut-off point models by being robust for all individual ’s physiological and non-physiological characteristics and showing more performance of an acceptable level over the whole range of physical activity intensities . Therefore , we propose that R and om Forest machine learning may be optimal for objective assessment of sedentary behaviour and physical activity in older adults using thigh-mounted triaxial accelerometry",
"Purpose Machine learning methods could better improve the detection of specific types of physical activities and sedentary behaviors from accelerometer data . No studies in older population s have developed and tested algorithms for walking and sedentary time in free-living daily life . Our goal was to rectify this gap by leveraging access to data from two studies in older women . Methods In study 1 , algorithms were developed and tested in a sample of older women ( N = 39 , age range = 55–96 yr ) in the field . Women wore accelerometers and SenseCam ( ground truth annotation ) devices for 7 d , yielding 3191 h and 320 d of data . Images were annotated and time matched to accelerometer data , and r and om forest classifiers labeled behaviors ( sitting , riding in a vehicle , st and ing still , st and ing moving , and walking/running ) . In study 2 , we examined the concurrent validity of the algorithms using accelerometer data from an observed 400-m walk test ( 2983 min of data available ) and 6 d of wearing both accelerometers and global positioning systems devices in a sample of 222 women ( age range = 67–100 ; 313,290 min of data available ) . Analyses included sensitivity , specificity balanced accuracy , and precision , as appropriate , averaged over each test participant at the minute level for each behavior . Results In study 1 , the algorithms had 82.2 % balanced accuracy . In study 2 , the classifier had 87.9 % accuracy for predicting walking . Overall machine learning classifiers and global positioning systems had 88.6 % agreement . Conclusions Free-living algorithms for walking and sedentary time yielded high levels of accuracy and concurrent validity and can be applied to existing accelerometer data from older women"
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BACKGROUND Panic disorder can be treated with pharmacotherapy , psychotherapy or in combination , but the relative merits of combined therapy have not been well established . OBJECTIVES To review evidence concerning short- and long-term advantages and disadvantages of combined psychotherapy plus antidepressant treatment for panic disorder with or without agoraphobia , in comparison with either therapy alone . SEARCH STRATEGY The Cochrane Collaboration Depression , Anxiety and Neurosis Controlled Trials Registers ( CCDANCTR- Studies and CCDANCTR-References ) were search ed on 11/10/2005 , together with a complementary search of the Cochrane Central Register of Controlled Trials and MEDLINE , using the keywords antidepressant and panic . A reference search , Sci Search and personal contact with experts were carried out . SELECTION CRITERIA Two independent review authors identified r and omised controlled trials comparing the combined therapy against either of the monotherapies among adult patients with panic disorder with or without agoraphobia . DATA COLLECTION AND ANALYSIS Two independent review authors extracted data using predefined data formats , including study quality indicators . The primary outcome was relative risk ( RR ) of " response " i.e. substantial overall improvement from baseline as defined by the original investigators . Secondary outcomes included st and ardised weighted mean differences in global severity , panic attack frequency , phobic avoidance , general anxiety , depression and social functioning and relative risks of overall dropouts and dropouts due to side effects . MAIN RESULTS We identified 23 r and omised comparisons ( representing 21 trials , 1709 patients ) , 21 of which involved behaviour or cognitive-behaviour therapies . In the acute phase treatment , the combined therapy was superior to antidepressant pharmacotherapy ( RR 1.24 , 95 % confidence interval ( CI ) 1.02 to 1.52 ) or psychotherapy ( RR 1.17 , 95 % CI 1.05 to 1.31 ) . The combined therapy produced more dropouts due to side effects than psychotherapy ( number needed to harm ( NNH ) around 26 ) . After the acute phase treatment , as long as the drug was continued , the superiority of the combination over either monotherapy appeared to persist . After termination of the acute phase and continuation treatment , the combined therapy was more effective than pharmacotherapy alone ( RR 1.61 , 95 % CI 1.23 to 2.11 ) and was as effective as psychotherapy ( RR 0.96 , 95 % CI 0.79 to 1.16 ) . AUTHORS ' CONCLUSIONS Either combined therapy or psychotherapy alone may be chosen as first line treatment for panic disorder with or without agoraphobia , depending on patient preference
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"The authors examined dose-response relationships in 62 agoraphobic patients receiving either imipramine or placebo under double-blind conditions in conjunction with behavioral interventions . At the end of 12 weeks , patients treated with imipramine had improved significantly more than placebo patients . Results revealed that the beneficial therapeutic effect of imipramine was dose dependent and suggested that optimal response in agoraphobia may require doses of 150 mg/day or more . The results also indicated that side effects can significantly interfere with the buildup of optimal dose in agoraphobic patients treated with imipramine . The authors briefly discuss the implication s of these findings for clinical practice and future research",
"This study examined pretreatment factors associated with attrition from a clinical trial for panic disorder . The study group consisted of 162 patients who began 11-visit treatments . Six domains ( demography , panic disorder severity , psychiatric comorbidity , illness/treatment attributions , coping styles , and personality styles ) with 52 variables were used to predict attrition . One hundred twenty-two patients completed and 40 dropped out from treatment . Final multivariate regression analyses showed that the following two variables were independently associated with attrition : lower household income and negative treatment attitudes ; attributing the panic disorder to life stressors and greater age were independently associated with attrition at the trend level . Preliminary analyses suggested , in addition , associations between attrition and lower education , shorter length of prior treatment , higher anxiety sensitivity , lower agoraphobic avoidance , and a coping style of seeking social support that were not confirmed by best predictor analysis . Psychiatric comorbidity and personality styles were unrelated to attrition . The implication s of these findings for future research and clinical practice are discussed",
" Among 79 volunteer , unpaid , family doctor-referred psychiatric out patients with DSM III-R panic disorder , with and without agoraphobia , 66 completed a six week placebo-controlled trial of lofepramine versus clomipramine and 57 survivors were followed up for 6 months . All subjects received one hour per week concurrent behavioural counselling in the acute phase . Of 13 dropouts in the first 3 weeks , 9 ( of 27 ) were on clomipramine , 2 ( of 26 ) were on lofepramine and 2 ( of 26 ) were on placebo . The high ( 30 % ) early dropout from the clomipramine group was largely due to medication intolerance . Both drugs were superior to placebo by the end of week 6 on several st and ard rating scales but not on panic attack frequency . No significant differences in efficacy were found between the two drugs tested to the end of 6 months . No tendency for relapse was noted in the three months following taper-off of medication from week 12 to week 24 . The study provides evidence that both drugs , in the dosages used , are superior to placebo in the acute phase of panic disorder in treatment-naive subjects concurrently receiving appropriate psychotherapy",
"Objective The present study examined the prevalence of panic disorder with or without agoraphobia according to DSM-IV criteria in the Swedish general population . Method Data were obtained by means of a postal survey administrated to 1000 r and omly selected adults . The panic disorder module of the World Health Organization 's Composite International Diagnostic Interview ( CIDI ) was included in the survey . Results 12-month prevalence was estimated at 2.2 % ( CI 95 % 1.02 % – 3.38 % ) . There was a significant sex difference , with a greater prevalence for women ( 5.6 % ) compared to men ( 1 % ) . Conclusion The Swedish panic disorder prevalence is relatively consistent with findings in most other parts of the western world",
"In a controlled- outcome study of phobias , 218 adult phobic patients ( 147 women and 71 men ) received a course of 26 weekly treatment sessions that consisted of behavior therapy ( BT ) and imipramine hydrochloride , BT and placebo , or supportive psychotherapy and imipramine . The BT consisted of systematic desentization using fantasy and assertiveness training . Patients were classified as agoraphobic , mixed phobic , or simple phobic . Although the conditions of most patients in each group showed moderate to marked improvement , the effects of imipramine were significantly superior to those of placebo in patients with spontaneous panic attacks , ie , patients with agoraphobia or mixed phobia . In patients with simple phobia , who do not experience spontaneous panic , there was not a significant difference between imipramine and placebo . This study clearly distinguished those phobic patients who experienced spontaneous panic from those who did not in terms of pharmacologic benefits",
"Thirty-seven severely-disabled agoraphobics were r and omly assigned to ( 1 ) Imipramine-no exposure . ( 2 ) Imipramine + exposure or ( 3 ) Placebo + exposure groups . To provide a more stringent test of the pharmacological effects of imipramine independent of exposure to phobic stimuli , Ss in the Imipramine-no exposure condition received antiexposure instructions during the first 8 weeks of therapy . Assessment s were conducted at 0 , 8 and 26 weeks . At 8 weeks , the group receiving imipramine combined with exposure therapy displayed more improvement than the other two groups , and was the only group to show a reduction in panic attacks . Ss receiving imipramine with antiexposure instructions showed little improvement on phobic indices , no reduction in panic , but significant improvement in anxiety and dysphoric mood . At 26 weeks Ss receiving the combined imipramine + exposure treatment exhibited further improvement result ing in a significant superiority of Imipramine + exposure over Placebo + exposure across a number of different outcome indices . Ss who had received imipramine with antiexposure instructions showed some improvement during the subsequent 18 weeks in which the antiexposure instructions were no longer in effect . However , neither this group nor the Placebo + exposure group showed a reduction in panic attacks . The results of the present trial provide support for the beneficial effects of combining intensive exposure with imipramine , but call into question the thesis that imipramine exerts its effect through a pharmacological blocking of panic attacks . Alternative hypotheses concerning the mode of action of imipramine are presented",
"We explored a causal sequence between panic and avoidance to provide recommendations for psychotherapy , pharmacotherapy , and their combination in treating agoraphobia . We produced a two-way [ ( imipramine hydrochloride vs placebo ] by [ office-based behavioral therapy vs in vivo exposure ] ) design by amalgamating two studies . We assessed agoraphobic patients for panic and avoidance at these time points : baseline ( week 0 ) , midcourse ( week 13 ) , and termination ( week 26 ) . The causal sequence model was tested by path analysis . Imipramine was superior to placebo in lowering panic and avoidance at both postbaseline time points . Exposure was superior to office-based treatment in lowering avoidance only at week 13 . Exposure appeared to produce quicker improvement of avoidance than office-based therapy , but relapse occurred if this improvement was not supported by medication . Exposure did not benefit panic . We believe patients should be informed that imipramine is superior to exposure in inducing a panic-free state . Exposure without imipramine is of benefit only in reducing avoidance , but adding imipramine to exposure is necessary for panic control and substantially improves exposure and exposure maintenance",
"The issue of panic disorder resistant to treatment ( whether pharmacological or psychological ) has attracted little research attention , despite its clinical frequency and importance . The aim of this study was to compare three treatment modalities , namely exposure alone ( E ) , exposure associated with imipramine ( EI ) and cognitive therapy supplementing exposure ( EC ) , in a sample of 21 patients with DSM‐IV panic disorder and agoraphobia , who failed to respond to a first st and ard course of individual behavioural treatment based on exposure in vivo . Treatments were administered according to a cross‐over , controlled design ( E‐EI‐EC , EI‐EC‐E , EC‐E‐EI ) . Twelve of the 21 patients achieved remission ( panic‐free status ) during the trial . In 8 cases this occurred after exposure alone ( E ) and in two cases each after the other treatments ( EI and EC ) . The results revealed a significant effect of the factor time on a number of variables , and the superiority of exposure alone compared to other treatment modalities with regard to some variables . These findings suggest that long‐term behavioural treatment based on exposure may be necessary in some patients , and may induce clinical remission . However , patients who do not respond to exposure show poor tolerance of and compliance with pharmacological treatment , and are unlikely to achieve remission with imipramine or cognitive therapy , even though this may occur in individual cases",
"OBJECTIVE Whereas the fact of attrition during the course of treatment is well documented , little is known about the factors that affect sample selection before the beginning of a study ( \" pretreatment attrition \" ) . The present study reports on the degree and sources of pretreatment attrition at two sites of a multicenter study on panic disorder that compared treatment outcomes for imipramine and cognitive behavior therapy . METHOD Data were collected at two clinical research sites , one with a pharmacological treatment orientation ( N = 420 ) and one with a psychosocial treatment orientation ( N = 208 ) . RESULTS The main source of pretreatment attrition was participant refusal . At both research sites , eligible patients most often refused participation because they were either unwilling to start treatment with imipramine ( 30.6 % and 47.4 % , respectively ) or discontinue their current medication ( 22.6 % and 35.1 % , respectively ) . CONCLUSIONS Results from comparative treatment outcome studies are limited not only to people who meet the study criteria but also to those who are willing to begin a medication treatment and discontinue their current medication",
"Sixty out- patients with severe agoraphobia took part in a controlled prospect i ve clinical trial of combinations of methohexitone-assisted and st and ard systematic desensitization and monoamine oxidase inhibitor . Severity of agoraphobia in terms of avoidance and anxiety was rated both by the patients themselves and by an independent assessor during the eight weeks of treatment . The monoamine oxidase inhibitor produced a significant reduction in severity of anxiety but not of avoidance . Methohexitone-assisted systematic desensitization appeared to produce significantly greater improvement than either st and ard systematic desensitization or no systematic desensitization in both anxiety and avoidance . Assessors ' ratings showed that the monoamine oxidase inhibitor used in conjunction with methohexitone-assisted systematic desnsitization produced slightly greater clinical improvement than the other treatment combinations",
"A large number of studies suggest that individual characteristics of psychotherapists affect the outcome of psychosocial treatments for psychiatric illness , but little work has been done to see if this is also the case for pharmacotherapy . In the context of a multicenter study that compared psychosocial and medication treatments for panic disorder , we assessed whether such characteristics as age of the psychiatrist , number of years of experience , and gender influence the outcome of treatment with the antipanic drug imipramine . Data were examined by multiple and logistic regression analyses for eight psychiatrists who treated a total of 57 patients with panic disorder . More physician experience , measured as years since completing residency , was associated with better response to imipramine on one of two main dichotomous measures ( the Clinical Global Impression-Improvement Scale ) and on six of nine continuous measure rating scales . Associations between psychiatrist age and outcome and between psychiatrist gender and outcome were also present but on fewer measures . Although these are post-hoc analyses that were not planned when the multicenter study was originally design ed and therefore there are limitations in the information available about the psychiatrists ' characteristics , the findings suggest that even in the context of a clinical trial that employs a specific protocol and single medication , physician experience may influence patient outcome . Depression and Anxiety 17:88 - 93 , 2003",
"A double-blind study was carried out on 40 agoraphobic and socially phobic patients , matched , then r and omly assigned to one of four treatment groups ; phenelzine-exposure , phenelzine-no exposure , placebo-exposure , and placebo-no exposure . Exposure consisted of encouraging the patient to face the phobic situation a predetermined number of times . Assessment s , made at the beginning and end of 8 weeks of therapy and 8 weeks thereafter , showed that the phobia ratings of groups decreased significantly . The combined exposure group improved significantly more than the combined no exposure group during treatment . At 8 weeks follow-up there was some deterioration in the phenelzine-exposure and placebo-no exposure groups . Exposure , with or without phenelzine , was the superior treatment modality . The antiphobic effect of phenelzine was not supported , although it seemed to reduce subjective anxiety during exposure experiences . The possibility that effect of phenelzine is dose-related is discussed",
"BACKGROUND Panic disorder , with and without agoraphobia , is a prevalent condition which presents primarily in general practice . Previous clinical outcome studies have been conducted mainly in specialist university departments or hospital setting s , and have tended to employ complex rating scales that are not well suited for use as outcome measures in primary care . AIM To evaluate the outcome , in a primary care setting , of fluvoxamine versus cognitive behaviour therapy , each used alone and in combination in a double-blind placebo-controlled framework , balanced for therapist contact . METHOD A total of 149 patients satisfying DSMIII-R criteria for panic disorder were r and omly allocated to receive one of the following : fluvoxamine , placebo , fluvoxamine plus cognitive behaviour therapy , placebo plus cognitive behaviour therapy , and cognitive behaviour therapy alone . These five treatment groups represent the minimum number acceptable for such a comparison to be made . All patients received an identical schedule of contact over 13 weeks . Measures of symptom severity , general health and social disruption were taken at entry point and end point ; measures of change in symptoms were taken at end point only . Outcome was reported in terms of brief global ratings of severity of illness and change in symptoms , and of ratings of general health and social disruption that are suitable for use in general practice . RESULTS All active treatment groups showed statistically significant advantages over placebo over a range of outcome ratings . The groups employing cognitive behaviour therapy showed the most robust and consistent response . CONCLUSION The brief global measures reported here proved adequate to the task of assessing treatment outcome . Results indicate that treatments including cognitive behaviour therapy can be effective in the treatment of panic disorder and agoraphobia in primary care",
"We analysed 113 reports published in 1980 in a sample of medical journals to relate features of study design to the magnitude of gains attributed to new therapies over old . Overall we rated 87 per cent of new therapies as improvements over st and ard therapies . The mean gain ( measured by the Mann-Whitney statistic ) was relatively constant across study design s , except for non-r and omized controlled trials with sequential assignment to therapy , which showed a significantly higher likelihood that a patient would do better on the innovation than on st and ard therapy ( p = 0.004 ) . R and omized controlled trials that did not use a double-blind design had a higher likelihood of showing a gain for the innovation than did double-blind trials ( p = 0.02 ) . Any evaluation of an innovation may include both bias and the true efficacy of the new therapy , therefore we may consider making adjustments for the average bias associated with a study design . When interpreting an evaluation of a new therapy , readers should consider the impact of the following average adjustments to the Mann-Whitney statistic : for trials with non-r and om sequential assignment a decrease of 0.15 , for non-double-blind r and omized controlled trials a decrease of 0.11",
" Twenty-three patients meeting DSM-III criteria for agoraphobia with panic attacks and 14 age- , race- , and sex-matched nonanxious controls were tested in the laboratory and on a test walk in a shopping mall . The patients were tested before and after about 15 weeks of treatment with placebo and exposure therapy , imipramine and exposure therapy , or imipramine and initial antiexposure instructions . Controls were tested twice at a similar interval , but without any treatment . On test day 1 , patients compared to controls showed higher average heart rate and skin conductance levels and greater numbers of skin conductance fluctuations in the laboratory , and higher heart rates before and during the test walk . Between pretreatment and posttreatment tests , clinical ratings improved and skin conductance levels decreased in all treatment groups . Heart rate levels in the laboratory , on the other h and , decreased in patients on placebo and rose in patients on imipramine . Thus , imipramine compromises the usefulness of heart rate as a measure of emotional arousal . Higher pretreatment heart rates predicted greater clinical improvement",
"Forty-five chronic agoraphobics were r and omly assigned to treatment by placebo or imipramine in doses up to 200 mg/day for 28 weeks . All patients also had systematic self-exposure homework with an instruction manual . In addition , half of each drug group had therapist-aided exposure and half had therapist-aided relaxation , each totalling three hours . Patients in both drug groups improved substantially and maintained their gains for one year of follow-up . Imipramine had no significant therapeutic effect despite satisfactory plasma levels and significant drug side effects . Patients ' low initial Hamilton depression scores might explain the absence of any drug effect . Antidepressants may be ineffective for agoraphobics who have normal mood . Brief therapist-aided exposure improved phobias and panics to a significant but limited extent , and is a useful adjuvant to self-exposure homework , which can be a powerful therapeutic agency by itself",
"BACKGROUND Current recommendations suggest that pharmacotherapy for patients with panic disorder should be continued for at least 1 year [ Am . J. Psychiatry 155 ( 1998 ) 1 ] , despite a paucity of data systematic ally examining outcome for periods greater than 3 - 6 months . It is critically important to obtain more information on the effectiveness of medications over time for patients who initially responded to pharmacotherapy for panic disorder . METHODS Long-term outcome was examined for 78 patients who attained a 2-month period of sustained remission on medication and received maintenance pharmacotherapy for up to 24 months during the Massachusetts General Hospital Longitudinal Study of Panic Disorder , a prospect i ve , naturalistic study . Participants were categorized by their maintenance treatment condition at remission : benzodiazepine alone ( N = 45 , 58 % ) , antidepressant alone ( N = 12 , 16 % ) , and combined treatment with a benzodiazepine and an antidepressant ( N = 21 , 27 % ) . RESULTS Approximately half ( N = 36 , 46 % ) of the patients who had achieved remission relapsed at some time over the 2-year naturalistic study period , despite continued and adequate pharmacotherapy . There was no difference in timing or frequency of relapse by type of maintenance pharmacotherapy . LIMITATIONS Interpretation of the data is limited by the naturalistic nature of the study , and by the relatively low sample size . CONCLUSIONS This data suggests that patients with panic disorder have a high rate of relapse even after acute response to pharmacotherapy , despite continued treatment . In addition , the use of combined pharmacotherapy with antidepressants and benzodiazepines does not appear to provide greater protection from relapse than monotherapy",
"BACKGROUND Both cognitive-behavioral therapy and treatment with selective serotonin reuptake inhibitors ( SSRIs ) have proved to be effective in the treatment of panic disorder . The present study examined the effects of paroxetine added to continued cognitive-behavioral therapy in patients who were unsuccessfully treated with initial cognitive-behavioral therapy alone . METHOD 161 patients with panic disorder with or without agoraphobia ( DSM-IV criteria ) underwent a manual-guided cognitive-behavioral therapy of 15 sessions . Forty-three unsuccessfully treated patients from this group were included in a double-blind , placebo-controlled , next-step treatment study consisting of continued cognitive-behavioral therapy plus adjunctive paroxetine at a dose of 40 mg/day or continued cognitive-behavioral therapy plus placebo . RESULTS Overall , patients in the cognitive-behavioral therapy plus paroxetine condition improved significantly on agoraphobic behavior ( p anxiety discomfort ( p cognitive-behavioral therapy plus placebo condition did not . Effect sizes in the cognitive-behavioral therapy plus paroxetine condition ranged from 1.0 to 1.8 and in the cognitive-behavioral therapy plus placebo condition , from 0.4 to 1.0 . CONCLUSION Patients with panic disorder who are unsuccessfully treated with initial cognitive-behavioral therapy may benefit from the addition of an SSRI as a second treatment modality . The importance of timely evaluation of treatment results is emphasized",
" Twenty eight participants , initially treated for specific phobia as part of a comparative treatment study , were evaluated 10 to 16 years ( X = 12 years ) later . A comprehensive , in-person , semi-structured diagnostic interview was utilized , which also assessed comorbid disorders . Of 21 patients who had been rated as responders ( much improved or very much improved ) at treatment termination , 13 ( 62 % ) had clinical ly significant avoidance or endurance with dread subsequent to treatment . Among a subgroup of these responders who had been considered completely recovered ( n = 11 ) , 5 ( 45 % ) had clinical ly significant symptoms following treatment . None of the seven subjects who had been considered unimproved at treatment termination recovered from phobia symptoms in the intervening years . Positive response to treatment was associated with better long term outcome . Clinical characteristics , such as phobia subtype , age of onset , baseline severity , and lifetime comorbidity of other psychiatric disorders were not associated with long term outcome in this sample . Type of treatment was not associated with long term outcome . Results challenge the notion that recovery from specific phobia following treatment is characterized by complete and enduring cessation of symptoms",
"In a controlled outcome study of phobias , 111 adult patients ( 69 % women , 31 % men ) received a course of 26 weekly treatment sessions consisting of ( 1 ) behavior therapy and imipramine hydrochloride ( 2 ) behavior therapy and placebo , or ( 3 ) supportive psychotherapy and imipramine . Patients were classified as agoraphobic , mixed phobic , or simple phobic . The great majority of patients in all groups showed moderate to marked global improvement ( 70 % to 86 % , depending on rater ) . In agoraphobics and mixed phobics ( both groups experiencing spontaneous panic attacks ) , imipramine was significantly superior to placebo . There was no difference between behavior therapy and supportive therapy , both result ing in high improvement rates ( 76 % to 100 % , depending on rater ) . In simple phobic patients , there was a high rate of improvement with all treatment regimens ( 72 % to 93 % , depending on rater ) , with no significant difference between imipramine and placebo or between behavior therapy and supportive therapy . Of 88 moderately to markedly improved patients followed up for one year after completing treatment , 83 % maintained their gains and 17 % relapsed . No patients showed symptom substitution . Eighteen percent of the patients receiving imipramine hydrochloride showed marked stimulant side effects on from 5 to 75 mg/day",
"Controlled clinical trials of the treatment of acute myocardial infa rct ion offer a unique opportunity for the study of the potential influence on outcome of bias in treatment assignment . A group of 145 papers was divided into those in which the r and omization process was blinded ( 57 papers ) , those in which it may have been unblinded ( 45 papers ) , and those in which the controls were selected by a nonr and om process ( 43 papers ) . At least one prognostic variable was maldistributed ( P less than 0.05 ) in 14.0 per cent of the blinded-r and omization studies , in 26.7 per cent of the unblinded-r and omization studies , and in 58.1 per cent of the nonr and omized studies . Differences in case-fatality rates between treatment and control groups ( P less than 0.05 ) were found in 8.8 per cent of the blinded-r and omization studies , 24.4 per cent of the unblinded-r and omization studies , and 58.1 per cent of the nonr and omized studies . These data emphasize the importance of keeping those who recruit patients for clinical trials from suspecting which treatment will be assigned to the patient under consideration",
" Eighteen agoraphobic patients with r and omly assigned to 12 week treatment with imipramine ( I ) or imipramine and programmed in-vivo exposure practice ( I+BT ) to investigate the contribution of behavioural instructions to the clinical effects of pharmacotherapy . Significantly greater improvement on phobic measures was found in the I+BT group compared to the I group . Differences were less marked on measures of panic and anxiety . The results suggest that imipramine possesses an antiphobic effect which can be substantially enhanced with programmed practice . Controlled large-scale investigations of the pharmacological and instructional effects of the phamacotherapy of agoraphobia are needed for a definitive evaluation of the specific antiphobic effect of antidepressant drugs",
"OBJECTIVE How far the results of r and omized controlled studies apply to everyday care can not be judged without regular measurements of outcomes in daily practice . We report on systematic data from a 3-year naturalistic prospect i ve study on panic disorder-agoraphobic ( PDA ) patients treated with antidepressants in a setting of routine clinical practice . Our aim is to describe the evolution of PDA in relation to the treatments employed , and to explore demographic and clinical characteristics that might be predictive of outcome . METHODS 326 DSM-III-R PDA patients treated with antidepressants in a setting of routine clinical practice were included in a 3-year naturalistic prospect i ve study . We utilized structured and semi-structures instruments , including the Structured Clinical Interview for Diagnosis and the Longitudinal Interview Follow-up Examination . The main antidepressants used were imipramine ( 39 % ) , clomipramine ( 28.5 % ) and paroxetine ( 23.3 % ) ; only 9 % of patients received other antidepressants . RESULTS 147 patients ( 45.1 % ) stayed on medication throughout the entire period of the follow-up . Of those who interrupted the treatment , 38 % stayed in remission . The probability of achieving at least one remission during the 3-year follow-up period was 96.5 % for PD and 95.9 % for Agoraphobia . Relapses after a period of at least 2 months of complete remission were also common , and the probability of presenting at least one relapse during the 3-years follow-up period was 67.1 % for PD and 39 % for Agoraphobia . The longest period of remission of PD is associated with low severity , medium-lasting course in patients with an onset of the illness in young adulthood . Less severe agoraphobia associated with moderately severe panic attacks appears to confer a better control of phobic behavior . All three major drugs were reasonably well tolerated ( only 9 % dropped out because of side effects ) , with sexual dysfunction and increased appetite being the most common side effects at the last evaluation ; in the first phase of the treatment anticholinergic effects and jitteriness were more common with TCAs . CONCLUSION Both classical antidepressants and paroxetine emerge as a useful treatment in the long-term management of PDA ; paroxetine appears particularly useful in PDA patients because it was significantly less likely to induce jitteriness , thereby reducing barriers to compliance",
"Endogenous anxiety ( anxiety hysteria , agoraphobia with panic attacks ) is characterized by sudden , spontaneous panic attacks accompanied by multiple autonomic symptoms , overwhelming fear , a flight response , and polyphobic behavior . Psychotherapy , behavior therapy , and tranquillizers have been of limited success in treating this syndrome . Fifty-seven patients severely disabled by the syndrome for a mean period of 13 years completed the three-month study . R and omly assigned in a double-blind , placebo-controlled design to imipramine hydrochloride , pheneizine sulfate , or placebo , they were seen in supportive group therapy every two weeks . Patients in the pheneizine and imipramine cells showed significant improvement ovehe persistent trend for pheneizine to be superior to imipramine achieved significance only on the Work and Social Disability Scale and the Sympton Severity and Phobic Avoidance Scale . The implication s for classification and theory are discussed",
" Sixty-two agoraphobic patient who had completed a controlled study of therapist-assisted in vivo exposure ( flooding ) and imipramine were assessed 1 month , 6 months , 1 year , and 2 years later . Overall , improvement during treatment was maintained throughout follow-up . At 1 month but not subsequently , imipramine and flooding had significant effects on central measures of agoraphobia . Patients who were marked treatment responders had a favorable clinical course and did not experience secondary depression , unlike patients who had not responded markedly to treatment . These findings suggest that treatments which evoke maximum therapeutic benefit initially are likely to foster long-term maintenance and reduce subsequent depressive sequelae",
" Sixty-two chronically agoraphobic patients completed a controlled study to assess the effects of 1 ) imipramine up to 200 mg/day ( mean = 130 mg/day ) , 2 ) 12 weekly therapist-assisted in vivo exposure sessions ( flooding ) , and 3 ) imipramine plus flooding . The control group received systematic therapeutic instructions for self-directed in vivo exposure ( programmed practice ) . Clinical measures of global severity , phobia , panic , anxiety , depression , and behavioral performance tests were administered before treatment and at Weeks 4 , 8 , and 12 of treatment . Results revealed significant improvement in all groups on all measures over the course of treatment ; almost a third of the control patients showed marked improvement . Imipramine had significant effects on improvement of phobias and markedly increased clinical response rates in patients receiving 150 - 200 mg/day . Less chronicity and severity of condition also predicted better clinical outcome . Flooding had limited effects above and beyond programmed practice , and no imipramine-flooding interactions effects were found",
"Systematic hierarchical desensitization ( behavior therapy [ BT ] ) was compared with supportive psychotherapy ( ST ) during a 26-week treatment trial of patients with agoraphobia , mixed phobia , or simple phobia . We found essentially no difference in effectiveness , not because patients treated with BT had done badly , but because patients receiving ST had done well . A detailed method ologic review concludes that this finding is entirely compatible with the major critical review s of the psychotherapy literature . Is the active ingredient in psychotherapy simply the generation of hopeful expectancies ? This is necessary but not sufficient . For phobics , the psychotherapy session serves primarily as an instigator . The specific corrective activity occurs outside of the formal session in the form of maintained exposure in vivo . Supposed differences between therapies may be entirely due to the rapidly with which the instigational function becomes effective",
"Two years after completion of a controlled outcome study of treatments for panic disorder with agoraphobia , patients were revisited and interviewed about their complaints . In the initial study , four treatments had been compared : ( i ) fluvoxamine combined with exposure ; ( ii ) placebo medication plus exposure ; ( iii ) psychological panic management plus exposure : and ( iv ) exposure alone . Comparison of the results at post‐test had revealed superior efficacy of fluvoxamine combined with exposure over the other three treatments in reducing agoraphobic avoidance . The current naturalistic follow‐up study investigated the long‐term efficacy of the treatments with regard to abatement of complaints and reduced dem and for further treatment . In addition , we examined whether patients were able to taper off the study medication without a recurrence of complaints . In total , 71 of the 76 patients of the original trial ( 93 % ) were interviewed . Comparison of the mean level of psychopathology at follow‐up revealed no difference between the original treatment groups . The effect in the fluvoxamine plus exposure group was maintained , but was no longer superior , due to further improvements in the other treatment groups . Most patients received additional treatment during the follow‐up period , usually because the 12 treatment sessions in the controlled study had yielded insufficient improvement . There was a trend for patients who received the fluvoxamine plus exposure treatment to require less aftercare than those who received the other treatments . Finally , almost 50 % of the patients who had received medication in the original trial were able to taper off the use of fluvoxamine without a recurrence of complaints",
" Forty-five agoraphobic out- patients were r and omly assigned to treatment with imipramine or placebo , and also to brief therapist-aided exposure or relaxation . All patients did systematic self-exposure homework and recorded this in a diary . Forty of these patients were followed-up two years later with self-ratings and ratings by interviewers blind to their treatment conditions . About two-thirds of the patients remained improved or much improved in their phobias , with no significant difference between any of the four treatment conditions . Spontaneous panics also remained improved . The absence of an imipramine effect may reflect the lack of initial dysphoria ( anxiety-depression ) in this sample compared with other studies where drug-effects have been found . The post-treatment superiority ( evident at week 28 ) of patients who had therapist-aided exposure was no longer present at the two-year follow-up ; the others had caught up , presumably because of their self-exposure homework",
"It has been suggested that maintenance treatment of patients who have remitted panic disorder with agoraphobia beyond the six months of acute phase imipramine treatment may decrease the risk of relapse . This study further explores the relationship between relapse and duration of imipramine treatment in this population . Fifty-one patients , all in remission at the end of six months acute phase open trial with imipramine 2.25 mg/kg/day and r and omized to double-blind maintenance or placebo substitution , discontinued imipramine treatment eventually and were followed over a 12-month risk period : 27 during first year placebo substitution , 7 after 12 months of imipramine maintenance in placebo substitution , and 17 after variable duration s of imipramine maintenance in open discontinuation . There were no behaviorally oriented interventions or instructions at any time during the acute and maintenance phases of treatment or during imipramine discontinuation . Duration of imipramine treatment , the method of discontinuation ( open versus placebo substitution ) , or any of the 9 variables from the demographic , clinical , and open treatment domains that were entered in a Cox proportional hazard model did not predict relapse . The rate of relapse after only 6 months of treatment ( 10 out of 27 , 37 % ) was identical to the rate of relapse after 12 to 30 months of treatment ( 9 out of 24 , 37.5 % ) . The results suggest a lack of specific protective effects beyond prophylaxis and underscore the difficulty in predicting relapse in fully remitted panic disorder with agoraphobia patients . Early detection of relapse in patients who discontinue treatment may be a viable alternative to prediction",
"CONTEXT Panic disorder ( PD ) may be treated with drugs , psychosocial intervention , or both , but the relative and combined efficacies have not been evaluated in an unbiased fashion . OBJECTIVE To evaluate whether drug and psychosocial therapies for PD are each more effective than placebo , whether one treatment is more effective than the other , and whether combined therapy is more effective than either therapy alone . DESIGN AND SETTING R and omized , double-blind , placebo-controlled clinical trial conducted in 4 anxiety research clinics from May 1991 to April 1998 . PATIENTS A total of 312 patients with PD were included in the analysis . INTERVENTIONS Patients were r and omly assigned to receive imipramine , up to 300 mg/d , only ( n=83 ) ; cognitive-behavioral therapy ( CBT ) only ( n=77 ) ; placebo only ( n=24 ) ; CBT plus imipramine ( n=65 ) ; or CBT plus placebo ( n=63 ) . Patients were treated weekly for 3 months ( acute phase ) ; responders were then seen monthly for 6 months ( maintenance phase ) and then followed up for 6 months after treatment discontinuation . MAIN OUTCOME MEASURES Treatment response based on the Panic Disorder Severity Scale ( PDSS ) and the Clinical Global Impression Scale ( CGI ) by treatment group . RESULTS Both imipramine and CBT were significantly superior to placebo for the acute treatment phase as assessed by the PDSS ( response rates for the intent-to-treat [ ITT ] analysis , 45.8 % , 48.7 % , and 21.7 % ; P=.05 and P=.03 , respectively ) , but were not significantly different for the CGI ( 48 . 2 % , 53.9 % , and 37.5 % , respectively ) . After 6 months of maintenance , imipramine and CBT were significantly more effective than placebo for both the PDSS ( response rates , 37.8 % , 39.5 % , and 13.0 % , respectively ; P=.02 for both ) and the CGI ( 37.8 % , 42.1 % , and 13.0 % , respectively ) . Among responders , imipramine produced a response of higher quality . The acute response rate for the combined treatment was 60.3 % for the PDSS and 64.1 % for the CGI ; neither was significantly different from the other groups . The 6-month maintenance response rate for combined therapy was 57.1 % for the PDSS ( P=.04 vs CBT alone and P=.03 vs imipramine alone ) and 56.3 % for the CGI ( P=.03 vs imipramine alone ) , but not significantly better than CBT plus placebo in either analysis . Six months after treatment discontinuation , in the ITT analysis CGI response rates were 41.0 % for CBT plus placebo , 31.9 % for CBT alone , 19.7 % for imipramine alone , 13 % for placebo , and 26.3 % for CBT combined with imipramine . CONCLUSIONS Combining imipramine and CBT appeared to confer limited advantage acutely but more substantial advantage by the end of maintenance . Each treatment worked well immediately following treatment and during maintenance ; CBT appeared durable in follow-up . JAMA . 2000;283:2529 -",
"In a double-blind , placebo-controlled trial comparing alprazolam and imipramine for panic disorder , serum analysis revealed that a substantial proportion of the patients took explicitly prohibited anxiolytic medication . Excluding these patients changed the results",
"Five years after treatment in a controlled trial , in which all had received self-exposure homework , a group of 40 agoraphobic out patients retained marked improvement in agoraphobia , mood , and free-floating anxiety . Frequency of spontaneous panics decreased as much in those who had placebo and self-exposure as in those who received imipramine and self-exposure . Few patients , however , were completely well at 5 years and over half had received further treatment for agoraphobia during the follow-up . Patients who were still highly phobic at the end of the clinical trial were more often prescribed psychotropic medication during follow-up and remained phobic at 5 years . Phobic improvement had generalized more in those patients with very low than in those with moderate pretreatment Hamilton depression scores . Frequency of initial spontaneous panics did not predict outcome . Improvement in agoraphobia was associated with improved marital adjustment . Those who began with the best marital , work , and social adjustment were more improved in their phobias 5 years later",
"Selective serotonin re-uptake inhibitors ( SSRIs ) and cognitive behavioral therapies ( CBTs ) are both considered as first-line treatments for panic disorder , but the advantages of a combined therapy have yet to be definitively demonstrated . We evaluated in this pilot study the effects of combining SSRIs ( vs. a placebo ) with a very brief form of cognitive-behavioral therapy provided to all participants . Thirty-three subjects with DSM-IV panic disorder , with or without agoraphobia , were r and omized to receive either paroxetine or a placebo with flexible dosing ( 10 - 50 mg/day ) . Medication visits were brief ( 15 min ) , infrequent ( 6 in total ) and non-directive . An expert cognitive-behavior therapist administered one initial 45-min session and one subsequent 30-min session of very brief CBT ( vbCBT ) at weeks 5 and 7 , respectively . Sessions were supplemented with educational and directive reading material s. Patients in both groups ( i.e. vbCBT+paroxetine ; vbCBT+placebo ) improved similarly and substantially on most measures during the 10 weeks of acute treatment . At week 10 , the proportion of panic-free patients was significantly higher in the paroxetine-treated group than in the placebo group ( 80 vs. 25 % ; P<0.007 ) , as was the proportion of subjects who rated themselves as ' very much improved ' at week 10 ( 60 vs. 13 % ; P<0.017 ) . These findings point to the need for additional studies to confirm the effectiveness of very brief forms of CBT , and to document the circumstances in which combined treatment with an SSRI would be warranted",
" Summary Twenty-seven agoraphobic out patients received eight sessions of flooding in fantasy with anxiety , flooding in fantasy with intravenous Brevital , or an attention-control procedure . Results on subjective rating scales provide some support for the hypothesis that agoraphobic clients benefit more from experiencing anxiety during flooding . No significant differences were found on a behavioral task . These results differ from previous findings where diazepam ( Valium ) was found to have no effect on outcome or to enhance improvement in agoraphobics . The discrepancy may be due to differences in the procedure",
"Seventy-six white agoraphobic women , 21 to 45 years old , were treated with combined group exposure in vivo and imipramine or placebo in a r and omized double-blind study . A majority of the patients in both the placebo and imipramine groups showed moderate to marked improvement . However , imipramine therapy was significantly superior to placebo therapy on three of the four reported measures of improvement : primary phobia , spontaneous panic , and global improvement . There was a negative correlation between depression and outcome ; ie , the more depressed patients fared worse on several outcome measures than those who were less depressed . A comparison of these patients with agoraphobic women previously treated with imipramine and imaginal desensitization showed a superiority of exposure in vivo midway in treatment , but no significant difference between the two groups at the completion of therapy",
"BACKGROUND A recent review suggested an association between using unpublished scales in clinical trials and finding significant results . AIMS To determine whether such an association existed in schizophrenia trials . METHOD Three hundred trials were r and omly selected from the Cochrane Schizophrenia Group 's Register . All comparisons between treatment groups and control groups using rating scales were identified . The publication status of each scale was determined and cl aims of a significant treatment effect were recorded . RESULTS Trials were more likely to report that a treatment was superior to control when an unpublished scale was used to make the comparison ( relative risk 1.37 ( 95 % CI 1.12 - 1.68 ) ) . This effect increased when a ' gold-st and ard ' definition of treatment superiority was applied ( RR 1.94 ( 95 % CI 1.35 - 2.79 ) ) . In non-pharmacological trials , one-third of ' gold-st and ard ' cl aims of treatment superiority would not have been made if published scales had been used . CONCLUSIONS Unpublished scales are a source of bias in schizophrenia trials",
"Preliminary reports of discontinuation of alprazolam therapy in patients with panic disorder have revealed worsening of symptoms despite gradual withdrawal of medication . In this study , 126 patients with panic disorder and phobic avoidance received either alprazolam or placebo in doses of 2 to 10 mg daily for eight weeks . The medication was tapered over a period of four weeks , and patients were observed for another two weeks after all medication was discontinued . Sixty of the 63 alprazolam-treated patients and 49 of the 63 placebo-treated patients entered the taper and discontinuation study . After improvement in the active treatment period , the alprazolam-treated group had significant relapse between the first and last week of taper . However , during the second postdiscontinuation week , outcome scores were not significantly different from those of the placebo-treated group who did not deteriorate during taper . Twenty-seven percent of the alprazolam-treated group reported a rebound of panic attacks during taper and 13 % reported a rebound of anxiety on the Hamilton Anxiety Scale . No serious or life-threatening withdrawal symptoms were reported , but distinct , transient , mild to moderate withdrawal syndrome occurred in 35 % of the alprazolam-treated group and in none of the placebo-treated group . The coexistence of symptom rebound and a withdrawal syndrome occurred in 10 % of the alprazolam-treated group , but both subsided by the end of the second week without alprazolam . We recommend that patients with panic disorder be treated for a longer period , at least six months , and that medication be tapered over a more prolonged period , at least eight weeks , especially where high doses are employed",
" Ninety-three patients with panic disorder and mild or no agoraphobia were treated for their panic disorder by using either 11 sessions of individual cognitive-behavior therapy or imipramine . Before and after treatment , their panic disorder symptomatology was assessed , and a self-report measure was administered to measure personality disorder characteristics [ Klein et al. , 1990 : Wisconsin Personality Disorders Inventory ] . In addition , some patients received this personality assessment again after six monthly maintenance sessions . Both treatments were equally effective in reducing panic disorder symptomatology , and both treatments had a positive influence on personality disorder characteristics . Personality disorder characteristics did not predict treatment outcome in either group . The implication s of the findings for the assessment of personality and the treatment of panic disorder are discussed",
"BACKGROUND In the treatment of panic disorder with agoraphobia , the efficacy of pharmacological , psychological and combined treatments has been established . Unanswered questions concern the relative efficacy of such treatments . AIMS To demonstrate that moclobemide and cognitive-behavioural therapy ( CBT ) are effective singly and more effective in combination . METHOD Fifty-five patients were r and omly assigned to an eight-week treatment of : moclobemide plus CBT ; moclobemide plus clinical management ( ' psychological placebo ' ) ; placebo plus CBT ; or placebo plus clinical management . RESULTS Comparisons between treatments revealed strong effects for CBT . Moclobemide with clinical management was not superior to placebo . The combination of moclobemide with CBT did not yield significantly better short-term results than CBI with placebo . The CBT results remained stable during a six-month follow-up , although a substantial proportion of patients treated with placebo plus CBT needed additional treatment . CONCLUSIONS CBT was highly effective in the treatment of panic disorder with agoraphobia and reduced agoraphobia to levels that were comparable to those of non- clinical controls",
"OBJECTIVE The purpose of this comparative outcome study was to investigate whether the effects of exposure in vivo treatment for panic disorder with agoraphobia could be enhanced by adding interventions specifically for panic attacks before the start of exposure treatment . The additional effect of two types of treatment for panic attacks -- pharmacological ( fluvoxamine ) and psychological ( repeated hyperventilation provocations and respiratory training)--was examined . Thus , the combined treatment of panic interventions with exposure in vivo could be compared to exposure in vivo alone . METHOD Ninety-six patients were r and omly assigned to four treatment conditions : double-blind , placebo-controlled fluvoxamine followed by exposure in vivo , psychological panic management followed by exposure , and exposure in vivo alone . Outcome was assessed by self-report measures , a st and ardized multitask behavioral avoidance test , and continuous monitoring of panic attacks . Seventy-six patients completed the study . RESULTS All four treatments were effective and result ed in a significant decrease of agoraphobic avoidance . Moreover , the combination of fluvoxamine and exposure in vivo demonstrated efficacy superior to that of the other treatments and had twice as large an effect size ( difference between pre- and posttreatment scores ) on self-reported agoraphobic avoidance . The other treatments did not differ among each other in effectiveness . CONCLUSIONS Results of the study indicate that the short-term outcome of exposure in vivo treatment can be enhanced by adding fluvoxamine treatment . Psychological panic management combined with exposure was not superior to exposure alone of equal duration",
"BACKGROUND This study compared the efficacy and tolerability of paroxetine with placebo in the treatment of panic disorder . METHOD After three weeks of placebo , patients received 12 weeks of treatment with paroxetine ( 20 , 40 , or 60 mg ) or placebo , and finally two weeks of placebo . Dosages were adjusted according to efficacy and tolerability . St and ardised cognitive therapy was given to all patients . The primary measure of outcome was reduction in the number of panic attacks . RESULTS Analysis of the results showed statistically significant differences in favour of paroxetine between the two treatment groups in two out of the three primary measures of outcome , i.e. 50 % reduction in total number of panic attacks and number of panic attacks reduced to one or zero over the study period . For the third measure of outcome , the mean change in the total number of attacks from baseline , there was a positive trend in favour of paroxetine . The results of the primary measures of outcome were strongly supported by the results of the secondary efficacy measures of outcome . In addition , paroxetine , at all doses , was very well tolerated . CONCLUSION Paroxetine plus cognitive therapy was significantly more effective than placebo plus cognitive therapy in the treatment of panic disorder",
"BACKGROUND The aim of this study was to analyze the impact of pretreatment characteristics and personality disorders on the onset of response in the treatment of panic disorder . METHODS The data of 73 out- patients with panic disorder who had completed at least 6 weeks of a r and omized trial of 24 weeks of either paroxetine only or paroxetine combined with cognitive group-therapy were analyzed in a Cox proportional hazards model . RESULTS The likelihood of having responded to treatment ( defined by a CGI rating of improvement ) was more than twice as high for patients without a personality disorder or social phobia than for Patients with a personality disorder or social phobia . CONCLUSIONS We suggest that patients with these characteristics do benefit from prolonged treatment , and they may profit from an additional treatment focused on social anxiety"
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Importance High blood pressure ( BP ) is the most important risk factor for death and cardiovascular disease ( CVD ) worldwide . The optimal cutoff for treatment of high BP is debated . Objective To assess the association between BP lowering treatment and death and CVD at different BP levels . Data Sources Previous systematic review s were identified from PubMed , the Cochrane Data base of Systematic Review s , and the Data base of Abstract s of Review s of Effect . Reference lists of these review s were search ed for r and omized clinical trials . R and omized clinical trials published after November 1 , 2015 , were also search ed for in PubMed and the Cochrane Central Register for Controlled Trials during February 2017 . Study Selection R and omized clinical trials with at least 1000 patient-years of follow-up , comparing BP-lowering drugs vs placebo or different BP goals were included . Data Extraction and Synthesis Data were extracted from original publications . Risk of bias was assessed using the Cochrane Collaborations assessment tool . Relative risks ( RRs ) were pooled in r and om-effects meta-analyses with Knapp-Hartung modification . Results are reported according to PRISMA guidelines . Main Outcomes and Measures Prespecified outcomes of interest were all-cause mortality , cardiovascular mortality , major cardiovascular events , coronary heart disease ( CHD ) , stroke , heart failure , and end-stage renal disease . Results Seventy-four unique trials , representing 306 273 unique participants ( 39.9 % women and 60.1 % men ; mean age , 63.6 years ) and 1.2 million person-years , were included in the meta-analyses . In primary prevention , the association of BP-lowering treatment with major cardiovascular events was dependent on baseline systolic BP ( SBP ) . In trials with baseline SBP 160 mm Hg or above , treatment was associated with reduced risk for death ( RR , 0.93 ; 95 % CI , 0.87 - 1.00 ) and a substantial reduction of major cardiovascular events ( RR , 0.78 ; 95 % CI , 0.70 - 0.87 ) . If baseline SBP ranged from 140 to 159 mm Hg , the association of treatment with mortality was similar ( RR , 0.87 ; 95 % CI , 0.75 - 1.00 ) , but the association with major cardiovascular events was less pronounced ( RR , 0.88 ; 95 % CI , 0.80 - 0.96 ) . In trials with baseline SBP below 140 mm Hg , treatment was not associated with mortality ( RR , 0.98 ; 95 % CI , 0.90 - 1.06 ) and major cardiovascular events ( RR , 0.97 ; 95 % CI , 0.90 - 1.04 ) . In trials including people with previous CHD and mean baseline SBP of 138 mm Hg , treatment was associated with reduced risk for major cardiovascular events ( RR , 0.90 ; 95 % CI , 0.84 - 0.97 ) , but was not associated with survival ( RR , 0.98 ; 95 % CI , 0.89 - 1.07 ) . Conclusions and Relevance Primary preventive BP lowering is associated with reduced risk for death and CVD if baseline SBP is 140 mm Hg or higher . At lower BP levels , treatment is not associated with any benefit in primary prevention but might offer additional protection in patients with CHD
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[
"Background — Early after coronary artery bypass surgery ( CABG ) , activation of numerous neurohumoral and endogenous vasodilator systems occurs that could be influenced favorably by angiotensin-converting enzyme inhibitors . Methods and Results — The Ischemia Management with Accupril post – bypass Graft via Inhibition of the coNverting Enzyme ( IMAGINE ) trial tested whether early initiation ( ≤7 days ) of an angiotensin-converting enzyme inhibitor after CABG reduced cardiovascular events in stable patients with left ventricular ejection fraction ≥40 % . The trial was a double-blind , placebo-controlled study of 2553 patients r and omly assigned to quinapril , target dose 40 mg/d , or placebo , who were followed up to a maximum of 43 months . The mean ( SD ) age was 61 ( 10 ) years . The incidence of the primary composite end point ( cardiovascular death , resuscitated cardiac arrest , nonfatal myocardial infa rct ion , coronary revascularization , unstable angina or heart failure requiring hospitalization , documented angina , and stroke ) was 13.7 % in the quinapril group and 12.2 % in the placebo group ( hazard ratio 1.15 , 95 % confidence interval 0.92 to 1.42 , P=0.212 ) over a median follow-up of 2.95 years . The incidence of the primary composite end point increased significantly in the first 3 months after CABG in the quinapril group ( hazard ratio 1.52 , 95 % confidence interval 1.03 to 2.26 , P=0.0356 ) . Adverse events also increased in the quinapril group , particularly during the first 3 months after CABG . Conclusions — In patients at low risk of cardiovascular events after CABG , routine early initiation of angiotensin-converting enzyme inhibitor therapy does not appear to improve clinical outcome up to 3 years after CABG ; however , it increases the incidence of adverse events , particularly early after CABG . Thus , early after CABG , initiation of angiotensin-converting enzyme inhibitor therapy should be individualized and continually reassessed over time according to risk",
"To assess whether angiotensin-converting enzyme inhibitors and third-generation dihydropyridine calcium channel blockers ameliorate diabetic complications , we compared glomerular filtration rate ( GFR ; primary outcome ) , cardiovascular events , retinopathy , and neuropathy in 380 hypertensive type 2 diabetics with albuminuria DEM AND [ Delapril and Manidipine for Nephroprotection in Diabetes ] ) and r and omized to 3-year treatment with manidipine/delapril combination ( 10/30 mg/d ; n=126 ) , delapril ( 30 mg/d ; n=127 ) , or placebo ( n=127 ) . GFR was central ly measured by iohexol plasma clearance . Median monthly GFR decline ( interquartile range [ IQR ] ) was 0.32 mL/min per 1.73 m2 ( IQR : 0.16–0.50 mL/min per 1.73 m2 ) on combined therapy , 0.36 mL/min per 1.73 m2 ( IQR : 0.18–0.53 mL/min per 1.73 m2 ) on delapril , and 0.30 mL/min per 1.73 m2 ( IQR : 0.12–0.50 mL/min per 1.73 m2 ) on placebo ( P=0.87 and P=0.53 versus combined therapy or delapril , respectively ) . Similar findings were observed when baseline GFR values were not considered for slope analyses . Albuminuria was stable in the 3 treatment groups . The hazard ratio ( 95 % CI ) for major cardiovascular events between combined therapy and placebo was 0.17 ( 0.04–0.78 ; P=0.023 ) . Among 192 subjects without retinopathy at inclusion , the hazard ratio for developing retinopathy between combined therapy and placebo was 0.27 ( 0.07–0.99 ; P=0.048 ) . Among 200 subjects with central ized neurological evaluation , the odds ratios for peripheral neuropathy at 3 years between combined therapy or delapril and placebo were 0.45 ( 0.24–0.87 ; P=0.017 ) and 0.52 ( 0.27–0.99 ; P=0.048 ) , respectively . Glucose disposal rate decreased from 5.8±2.4 to 5.3±1.9 mg/kg per min on placebo ( P=0.03 ) but did not change on combined or delapril therapy . Treatment was well tolerated . In hypertensive type 2 diabetic patients , combined manidipine and delapril therapy failed to slow GFR decline but safely ameliorated cardiovascular disease , retinopathy , and neuropathy and stabilized insulin sensitivity",
"PURPOSE To evaluate the effect of long-term treatment with metoprolol after coronary bypass grafting on death and cardiac events . METHODS Patients in western Sweden on whom coronary artery bypass grafting was performed between June 1988 and June 1991 were evaluated for inclusion during the first 3 weeks after surgery . Major exclusion criteria were age > 75 years , concomitant valve surgery , traditional contraindications to beta-blockers and unwillingness to participate . Patients were r and omized in a double-blind fashion to 100 mg of metoprolol/placebo daily for 2 weeks and thereafter 200 mg daily for 2 years . RESULTS Of 2365 patients who were operated on , 967 were r and omized to either metoprolol ( n = 480 ) or placebo ( n = 487 ) . Primary end points ( death , non-fatal myocardial infa rct ion , unstable angina pectoris , need for coronary artery bypass grafting or percutaneous transluminal angioplasty ) , were reached by 42 patients in the metoprolol group ( 8.8 % ) , as compared with 39 in the placebo group ( 8.0 % ) ( P = 0.73 ) . Of all the patients r and omized to metoprolol , 34 % withdrew from blind treatment prematurely compared with 44 % for placebo ( P metoprolol over a 2-year period after coronary artery bypass grafting did not reduce death or the development of cardiac events . However , the 95 % confidence limits ranged from the possibility of a 30 % reduction in events to a 68 % increase in events if patients were treated with metoprolol as compared with placebo",
"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 The risks and benefits of treating hypertension in individuals older than 80 years are uncertain . A meta- analysis has suggested that a reduction in stroke events of 36 % may have to be balanced against a 14 % increase in total mortality . Objectives To report the results of the pilot study of the Hypertension in the Very Elderly Trial ( HYVET ) , which is in progress to address these issues . Methods The HYVET-Pilot was a multicentre international open pilot trial . In 10 European countries , 1283 patients older than 80 years and with a sustained blood pressure of 160–219/90–109 mmHg were allocated r and omly to one of three treatments : a diuretic-based regimen ( usually bendroflumethiazide ; n = 426 ) , an angiotensin-converting enzyme inhibitor regimen ( usually lisinopril ; n = 431 ) or no treatment ( n = 426 ) . The procedure permitted doses of the drug to be titrated and diltiazem slow-release to be added to active treatment . Target blood pressure was the reduction in stroke events relative hazard rate ( RHR ) was 0.47 [ 95 % confidence interval ( CI ) 0.24 to 0.93 ] and the reduction in stroke mortality RHR was 0.57 ( 95 % CI 0.25 to 1.32 ) . However , the estimate of total mortality supported the possibility of excess deaths with active treatment ( RHR 1.23 , 95 % CI 0.75 to 2.01 ) . Conclusions The preliminary results support the need for the continuing main HYVET trial . It is possible that treatment of 1000 patients for 1 year may reduce stroke events by 19 ( nine non-fatal ) , but may be associated with 20 extra non-stroke deaths ",
"Hypertension guidelines recommend blood pressure self-measurement at home ( HBP ) , but no previous trial has assessed cardiovascular outcomes in hypertensive patients treated according to HBP . The multicenter Hypertension Objective Treatment Based on Measurement by Electrical Devices of Blood Pressure ( HOMED-BP ; 2001–2010 ) trial involved 3518 patients ( 50 % women ; mean age 59.6 years ) with an untreated systolic/diastolic HBP of 135–179/85–119 mm Hg . In a 2 × 3 design , patients were r and omized to usual control ( 125–134/80–84 mm Hg ( UC ) ) vs. tight control ( ( TC ) ) of HBP and to initiation of drug treatment with angiotensin converting enzyme inhibitors , angiotensin receptor blockers or calcium channel blockers . During follow-up , a computer algorithm automatically generated treatment recommendations based on HBP . At the last follow-up ( median 5.3 years ) , TC patients used more antihypertensive drugs than UC patients ( 1.82 vs. 1.74 defined daily doses , P=0.045 ) and had a greater HBP reduction ( 21.3/13.1 mm Hg vs. 22.7/13.9 mm Hg , P=0.018/0.020 ) , but they less frequently achieved the lower HBP targets ( 37.4 vs. 63.5 % , P , cardiovascular death plus stroke and myocardial infa rct ion , occurred in 25 UC and 26 TC patients ( hazard ratio , 1.02 ; 95 % confidence interval , 0.59–1.77 ; P=0.94 ) . Rates were similar ( P⩾0.13 ) in the three drug groups . In all patients combined , the risk of the primary end point independently increased by 41 % ( 6–89 % ; P=0.019 ) and 47 % ( 15–87 % ; P=0.0020 ) for a 1-s.d . increase in baseline ( 12.5 mm Hg ) and follow-up ( 13.2 mm Hg ) systolic HBP . The 5-year risk was minimal ( ⩽1 % ) if on-treatment systolic HBP was 131.6 mm Hg or less . HOMED-BP proved the feasibility of adjusting antihypertensive drug treatment based on HBP and suggests that a systolic HBP level of 130 mm Hg should be an achievable and safe target",
"In this prospect i ve , r and omized , open-label , blinded end point study , we aim ed to establish whether strict blood pressure control ( moderate blood pressure control ( ≥140 mm Hg to cardiovascular mortality and morbidity in elderly patients with isolated systolic hypertension . We divided 3260 patients aged 70 to 84 years with isolated systolic hypertension ( sitting blood pressure 160 to 199 mm Hg ) into 2 groups , according to strict or moderate blood pressure treatment . A composite of cardiovascular events was evaluated for ≥2 years . The strict control ( 1545 patients ) and moderate control ( 1534 patients ) groups were well matched ( mean age : 76.1 years ; mean blood pressure : 169.5/81.5 mm Hg ) . Median follow-up was 3.07 years . At 3 years , blood pressure reached 136.6/74.8 mm Hg and 142.0/76.5 mm Hg , respectively . The blood pressure difference between the 2 groups was 5.4/1.7 mm Hg . The overall rate of the primary composite end point was 10.6 per 1000 patient-years in the strict control group and 12.0 per 1000 patient-years in the moderate control group ( hazard ratio : 0.89 ; [ 95 % CI : 0.60 to 1.34 ] ; P=0.38 ) . In summary , blood pressure targets of 140 mm Hg are safely achievable in relatively healthy patients ≥70 years of age with isolated systolic hypertension , although our trial was underpowered to definitively determine whether strict control was superior to less stringent blood pressure targets",
"BACKGROUND The risk of cardiovascular events among patients with atrial fibrillation is high . We evaluated whether irbesartan , an angiotensin-receptor blocker , would reduce this risk . METHODS We r and omly assigned patients with a history of risk factors for stroke and a systolic blood pressure of at least 110 mm Hg to receive either irbesartan at a target dose of 300 mg once daily or double-blind placebo . These patients were already enrolled in one of two trials ( of clopidogrel plus aspirin versus aspirin alone or versus oral anticoagulants ) . The first co primary outcome was stroke , myocardial infa rct ion , or death from vascular causes ; the second was this composite outcome plus hospitalization for heart failure . RESULTS A total of 9016 patients were enrolled and followed for a mean of 4.1 years . The mean reduction in systolic blood pressure was 2.9 mm Hg greater in the irbesartan group than in the placebo group , and the mean reduction in diastolic blood pressure was 1.9 mm Hg greater . The first co primary outcome occurred at a rate of 5.4 % per 100 person-years in both groups ( hazard ratio with irbesartan , 0.99 ; 95 % confidence interval [ CI ] , 0.91 to 1.08 ; P=0.85 ) . The second co primary outcome occurred at a rate of 7.3 % per 100 person-years among patients receiving irbesartan and 7.7 % per 100 person-years among patients receiving placebo ( hazard ratio , 0.94 ; 95 % CI , 0.87 to 1.02 ; P=0.12 ) . The rates of first hospitalization for heart failure ( a prespecified secondary outcome ) were 2.7 % per 100 person-years among patients receiving irbesartan and 3.2 % per 100 person-years among patients receiving placebo ( hazard ratio , 0.86 ; 95 % CI , 0.76 to 0.98 ) . Among patients who were in sinus rhythm at baseline , there was no benefit of irbesartan in preventing hospitalization for atrial fibrillation or atrial fibrillation recorded on 12-lead electrocardiography , nor was there a benefit in a subgroup that underwent transtelephonic monitoring . More patients in the irbesartan group than in the placebo group had symptomatic hypotension ( 127 vs. 64 ) and renal dysfunction ( 43 vs. 24 ) . CONCLUSIONS Irbesartan did not reduce cardiovascular events in patients with atrial fibrillation . ( Funded by Bristol-Myers Squibb and Sanofi-Aventis ; Clinical Trials.gov number , NCT00249795 . )",
"BACKGROUND In patients who have vascular disease or high-risk diabetes without heart failure , angiotensin-converting-enzyme ( ACE ) inhibitors reduce mortality and morbidity from cardiovascular causes , but the role of angiotensin-receptor blockers ( ARBs ) in such patients is unknown . We compared the ACE inhibitor ramipril , the ARB telmisartan , and the combination of the two drugs in patients with vascular disease or high-risk diabetes . METHODS After a 3-week , single-blind run-in period , patients underwent double-blind r and omization , with 8576 assigned to receive 10 mg of ramipril per day , 8542 assigned to receive 80 mg of telmisartan per day , and 8502 assigned to receive both drugs ( combination therapy ) . The primary composite outcome was death from cardiovascular causes , myocardial infa rct ion , stroke , or hospitalization for heart failure . RESULTS Mean blood pressure was lower in both the telmisartan group ( a 0.9/0.6 mm Hg greater reduction ) and the combination-therapy group ( a 2.4/1.4 mm Hg greater reduction ) than in the ramipril group . At a median follow-up of 56 months , the primary outcome had occurred in 1412 patients in the ramipril group ( 16.5 % ) , as compared with 1423 patients in the telmisartan group ( 16.7 % ; relative risk , 1.01 ; 95 % confidence interval [ CI ] , 0.94 to 1.09 ) . As compared with the ramipril group , the telmisartan group had lower rates of cough ( 1.1 % vs. 4.2 % , P angioedema ( 0.1 % vs. 0.3 % , P=0.01 ) and a higher rate of hypotensive symptoms ( 2.6 % vs. 1.7 % , P rate of syncope was the same in the two groups ( 0.2 % ) . In the combination-therapy group , the primary outcome occurred in 1386 patients ( 16.3 % ; relative risk , 0.99 ; 95 % CI , 0.92 to 1.07 ) ; as compared with the ramipril group , there was an increased risk of hypotensive symptoms ( 4.8 % vs. 1.7 % , P syncope ( 0.3 % vs. 0.2 % , P=0.03 ) , and renal dysfunction ( 13.5 % vs. 10.2 % , P CONCLUSIONS Telmisartan was equivalent to ramipril in patients with vascular disease or high-risk diabetes and was associated with less angioedema . The combination of the two drugs was associated with more adverse events without an increase in benefit . ( Clinical Trials.gov number , NCT00153101 [ Clinical Trials.gov ] . )",
"BACKGROUND The most appropriate targets for systolic blood pressure to reduce cardiovascular morbidity and mortality among persons without diabetes remain uncertain . METHODS We r and omly assigned 9361 persons with a systolic blood pressure of 130 mm Hg or higher and an increased cardiovascular risk , but without diabetes , to a systolic blood-pressure target of less than 120 mm Hg ( intensive treatment ) or a target of less than 140 mm Hg ( st and ard treatment ) . The primary composite outcome was myocardial infa rct ion , other acute coronary syndromes , stroke , heart failure , or death from cardiovascular causes . RESULTS At 1 year , the mean systolic blood pressure was 121.4 mm Hg in the intensive-treatment group and 136.2 mm Hg in the st and ard-treatment group . The intervention was stopped early after a median follow-up of 3.26 years owing to a significantly lower rate of the primary composite outcome in the intensive-treatment group than in the st and ard-treatment group ( 1.65 % per year vs. 2.19 % per year ; hazard ratio with intensive treatment , 0.75 ; 95 % confidence interval [ CI ] , 0.64 to 0.89 ; P All-cause mortality was also significantly lower in the intensive-treatment group ( hazard ratio , 0.73 ; 95 % CI , 0.60 to 0.90 ; P=0.003 ) . Rates of serious adverse events of hypotension , syncope , electrolyte abnormalities , and acute kidney injury or failure , but not of injurious falls , were higher in the intensive-treatment group than in the st and ard-treatment group . CONCLUSIONS Among patients at high risk for cardiovascular events but without diabetes , targeting a systolic blood pressure of less than 120 mm Hg , as compared with less than 140 mm Hg , result ed in lower rates of fatal and nonfatal major cardiovascular events and death from any cause , although significantly higher rates of some adverse events were observed in the intensive-treatment group . ( Funded by the National Institutes of Health ; Clinical Trials.gov number , NCT01206062 . )",
"Background The prevention of hypertension with the angiotensin-converting enzyme inhibitor ramipril in patients with high-normal blood pressure study addresses the issue of whether progression to manifest hypertension in patients with high-normal blood pressure can be prevented with treatment . Methods A total of 1008 participants with high-normal office blood pressure were r and omized to ramipril treatment group ( n = 505 ) and a control group ( n = 503 ) . The patients were followed up for 3 years . Primary endpoint was to prevent or delay the progression to manifest hypertension . Secondary endpoints were reduction in the incidence of cerebrovascular and cardiovascular events , as well as the development of hypertension as defined by ambulatory blood pressure monitoring . Findings One hundred and fifty-five patients ( 30.7 % ) in the ramipril group , and 216 ( 42.9 % ) in the control group reached the primary endpoint ( relative risk reduction 34.4 % , P = 0.0001 ) . Ramipril also proved to be more effective in reducing the incidence of manifest office hypertension in patients with baseline ambulatory blood pressure monitoring high-normal blood pressure . The incidence of cerebrovascular and cardiovascular events showed no statistically significant differences between the two groups . Cough was more frequent in the ramipril group ( 4.8 vs. 0.4 % ) . Interpretation There is now good clinical evidence that patients with high-normal blood pressure ( prehypertension ) are more likely to progress to manifest hypertension than patients with optimal or normal blood pressure . Additional ambulatory blood pressure monitoring seems to be essential to achieve correct diagnosis . Treatment of patients with high-normal office blood pressure with the angiotensin-converting enzyme inhibitor was well tolerated , and significantly reduced the risk of progression to manifest hypertension",
"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 It is unknown whether either the angiotensin-II-receptor blocker irbesartan or the calcium-channel blocker amlodipine slows the progression of nephropathy in patients with type 2 diabetes independently of its capacity to lower the systemic blood pressure . METHODS We r and omly assigned 1715 hypertensive patients with nephropathy due to type 2 diabetes to treatment with irbesartan ( 300 mg daily ) , amlodipine ( 10 mg daily ) , or placebo . The target blood pressure was 135/85 mm Hg or less in all groups . We compared the groups with regard to the time to the primary composite end point of a doubling of the base-line serum creatinine concentration , the development of end-stage renal disease , or death from any cause . We also compared them with regard to the time to a secondary , cardiovascular composite end point . RESULTS The mean duration of follow-up was 2.6 years . Treatment with irbesartan was associated with a risk of the primary composite end point that was 20 percent lower than that in the placebo group ( P=0.02 ) and 23 percent lower than that in the amlodipine group ( P=0.006 ) . The risk of a doubling of the serum creatinine concentration was 33 percent lower in the irbesartan group than in the placebo group ( P=0.003 ) and 37 percent lower in the irbesartan group than in the amlodipine group ( P irbesartan was associated with a relative risk of end-stage renal disease that was 23 percent lower than that in both other groups ( P=0.07 for both comparisons ) . These differences were not explained by differences in the blood pressures that were achieved . The serum creatinine concentration increased 24 percent more slowly in the irbesartan group than in the placebo group ( P=0.008 ) and 21 percent more slowly than in the amlodipine group ( P=0.02 ) . There were no significant differences in the rates of death from any cause or in the cardiovascular composite end point . CONCLUSIONS The angiotensin-II-receptor blocker irbesartan is effective in protecting against the progression of nephropathy due to type 2 diabetes . This protection is independent of the reduction in blood pressure it causes",
"BACKGROUND The multicenter double-blind , r and omized Bergamo Nephrologic Diabetes Complications Trial ( BENEDICT ) was design ed to assess whether angiotensin-converting-enzyme inhibitors and non-dihydropyridine calcium-channel blockers , alone or in combination , prevent microalbuminuria in subjects with hypertension , type 2 diabetes mellitus , and normal urinary albumin excretion . METHODS We studied 1204 subjects , who were r and omly assigned to receive at least three years of treatment with tr and olapril ( at a dose of 2 mg per day ) plus verapamil ( sustained-release formulation , 180 mg per day ) , tr and olapril alone ( 2 mg per day ) , verapamil alone ( sustained-release formulation , 240 mg per day ) , or placebo . The target blood pressure was 120/80 mm Hg . The primary end point was the development of persistent microalbuminuria ( overnight albumin excretion , > or = 20 microg per minute at two consecutive visits ) . RESULTS The primary outcome was reached in 5.7 percent of the subjects receiving tr and olapril plus verapamil , 6.0 percent of the subjects receiving tr and olapril , 11.9 percent of the subjects receiving verapamil , and 10.0 percent of control subjects receiving placebo . The estimated acceleration factor ( which quantifies the effect of one treatment relative to another in accelerating or slowing disease progression ) adjusted for predefined baseline characteristics was 0.39 for the comparison between verapamil plus tr and olapril and placebo ( P=0.01 ) , 0.47 for the comparison between tr and olapril and placebo ( P=0.01 ) , and 0.83 for the comparison between verapamil and placebo ( P=0.54 ) . Tr and olapril plus verapamil and tr and olapril alone delayed the onset of microalbuminuria by factors of 2.6 and 2.1 , respectively . Serious adverse events were similar in all treatment groups . CONCLUSIONS In subjects with type 2 diabetes and hypertension but with normoalbuminuria , the use of tr and olapril plus verapamil and tr and olapril alone decreased the incidence of microalbuminuria to a similar extent . The effect of verapamil alone was similar to that of placebo",
"Background Prehypertension is associated with higher cardiovascular risk , target organ damage , and incidence of hypertension . The Prevention of Hypertension in Patients with PreHypertension ( PREVER‐Prevention ) trial aim ed to evaluate the efficacy and safety of a low‐dose diuretic for the prevention of hypertension and end‐organ damage . Methods and Results This r and omized , parallel , double‐blind , placebo‐controlled trial was conducted in 21 Brazilian academic medical centers . Participants with prehypertension who were aged 30 to 70 years and who did not reach optimal blood pressure after 3 months of lifestyle intervention were r and omized to a chlorthalidone/amiloride combination pill or placebo and were evaluated every 3 months during 18 months of treatment . The primary outcome was incidence of hypertension . Development or worsening of microalbuminuria , new‐onset diabetes mellitus , and reduction of left ventricular mass were secondary outcomes . Participant characteristics were evenly distributed by trial arms . The incidence of hypertension was significantly lower in 372 study participants allocated to diuretics compared with 358 allocated to placebo ( hazard ratio 0.56 , 95 % CI 0.38–0.82 ) , result ing in a cumulative incidence of 11.7 % in the diuretic arm versus 19.5 % in the placebo arm ( P=0.004 ) . Adverse events ; levels of blood glucose , glycosylated hemoglobin , creatinine , and microalbuminuria ; and incidence of diabetes mellitus were no different between the 2 arms . Left ventricular mass assessed through Sokolow‐Lyon voltage and voltage‐ duration product decreased to a greater extent in participants allocated to diuretic therapy compared with placebo ( P=0.02 ) . Conclusions A combination of low‐dose chlorthalidone and amiloride effectively reduces the risk of incident hypertension and beneficially affects left ventricular mass in patients with prehypertension . Clinical Trial Registration URL : http://www . Clinical Trials.gov , www.ensaiosclinicos.gov . Unique identifiers : NCT00970931 , RBR‐74rr6s",
"BACKGROUND Calcium antagonists are widely prescribed for angina pectoris but their effect on clinical outcome is controversial . We aim ed to investigate the effect of the calcium antagonist nifedipine on long-term outcome in patients with stable angina pectoris . METHODS We r and omly assigned 3825 patients with treated stable symptomatic coronary disease to double-blind addition of nifedipine GITS ( gastrointestinal therapeutic system ) 60 mg once daily and 3840 to placebo . The primary endpoint was the combination of death , acute myocardial infa rct ion , refractory angina , new overt heart failure , debilitating stroke , and peripheral revascularisation . Mean follow-up was 4.9 years ( SD 1.1 ) . Analysis was by intention to treat . FINDINGS 310 patients allocated nifedipine died ( 1.64 per 100 patient-years ) compared with 291 people allocated placebo ( 1.53 per 100 patient-years ; hazard ratio 1.07 [ 95 % CI 0.91 - 1.25 ] , p=0.41 ) . Primary endpoint rates were 4.60 per 100 patient-years for nifedipine and 4.75 per 100 patient-years for placebo ( 0.97 [ 0.88 - 1.07 ] , p=0.54 ) . With nifedipine , rate of death and any cardiovascular event or procedure was 9.32 per 100 patient-years versus 10.50 per 100 patient-years for placebo ( 0.89 [ 0.83 - 0.95 ] , p=0.0012 ) . The difference was mainly attributable to a reduction in the need for coronary angiography and interventions in patients assigned nifedipine , despite an increase in peripheral revascularisation . Nifedipine had no effect on the rate of myocardial infa rct ion . INTERPRETATION Addition of nifedipine GITS to conventional treatment of angina pectoris has no effect on major cardiovascular event-free survival . Nifedipine GITS is safe and reduces the need for coronary angiography and interventions",
"OBJECTIVE The Appropriate Blood Pressure Control in Diabetes ( ABCD ) Trial is a prospect i ve r and omized blinded clinical trial that compares the effects of intensive versus moderate blood pressure control on the incidence and progression of type 2 diabetic complications . The current article discusses the results of 5.3 years of follow-up of 470 patients with hypertension and evaluates the effects of intensive and moderate blood pressure therapy using nisoldipine versus enalapril as the initial antihypertensive medication for nephropathy , retinopathy , and neuropathy . RESEARCH DESIGN AND METHODS The 470 hypertensive subjects , defined as having a baseline diastolic blood pressure of > or = 90 mmHg , were r and omized to intensive blood pressure control ( diastolic blood pressure goal of 75 mmHg ) versus moderate blood pressure control ( diastolic blood pressure goal of 80 - 89 mmHg ) . RESULTS The mean blood pressure achieved was 132/78 mmHg in the intensive group and 138/86 mmHg in the moderate control group . During the 5-year follow-up period , no difference was observed between intensive versus moderate blood pressure control and those r and omized to nisoldipine versus enalapril with regard to the change in creatinine clearance . After the first year of antihypertensive treatment , creatinine clearance stabilized in both the intensive and moderate blood pressure control groups in those patients with baseline normo- or microalbuminuria . In contrast , patients starting with overt albuminuria demonstrated a steady decline in creatinine clearance of 5 - 6 ml.min-1.1.73 m-2 per year throughout the follow-up period whether they were on intensive or moderate therapy . There was also no difference between the interventions with regard to individuals progressing from normoalbuminuria to microalbuminuria ( 25 % intensive therapy vs. 18 % moderate therapy , P = 0.20 ) or microalbuminuria to overt albuminuria ( 16 % intensive therapy vs. 23 % moderate therapy , P = 0.28 ) . Intensive therapy demonstrated a lower overall incidence of deaths , 5.5 vs. 10.7 % , P = 0.037 . Over a 5-year follow-up period , there was no difference between the intensive and moderate groups with regard to the progression of diabetic retinopathy and neuropathy . In addition , the use of nisoldipine versus enalapril had no differential effect on diabetic retinopathy and neuropathy . CONCLUSIONS Blood pressure control of 138/86 or 132/78 mmHg with either nisoldipine or enalapril as the initial antihypertensive medication appeared to stabilize renal function in hypertensive type 2 diabetic patients without overt albuminuria over a 5-year period . The more intensive blood pressure control decreased all-cause mortality",
"Abstract Objective To investigate whether a low dose of the angiotensin converting enzyme ( ACE ) inhibitor ramipril lowers cardiovascular and renal events in patients with type 2 diabetes who have microalbuminuria or proteinuria . Design R and omised , double blind , parallel group trial comparing ramipril ( 1.25 mg/day ) with placebo ( on top of usual treatment ) for cardiovascular and renal outcomes for at least three years . Setting Multicentre , primary care study conducted mostly by general practitioners in 16 European and north African countries . Participants 4912 patients with type 2 diabetes aged > 50 years who use oral antidiabetic drugs and have persistent microalbuminuria or proteinuria ( urinary albumin excretion 20 mg/l in two consecutive sample s ) , and serum creatinine ≤ 150 μmol/l . Main outcome measures The primary outcome measure was the combined incidence of cardiovascular death , non-fatal myocardial infa rct ion , stroke , heart failure leading to hospital admission , and end stage renal failure . Results Participants were followed for 3 to 6 ( median 4 ) years . There were 362 primary events among the 2443 participants taking ramipril ( 37.8 per 1000 patient years ) and 377 events among the 2469 participants taking placebo ( 38.8 per 1000 patient years ; hazard ratio 1.03 ( 95 % confidence interval 0.89 to 1.20 , P = 0.65 ) ) . None of the components of the primary outcome was reduced . Ramipril lowered systolic and diastolic blood pressures ( by 2.43 and 1.06 mm Hg respectively after two years ) and favoured regression from microalbuminuria ( 20 - 200 mg/l ) or proteinuria ( > 200mg/l ) to normal level ( ) in 1868 participants who completed the study . Conclusions Low dose ( 1.25 mg ) ramipril once daily has no effect on cardiovascular and renal outcomes of patients with type 2 diabetes and albuminuria , despite a slight decrease in blood pressure and urinary albumin . The cardiovascular benefits of a daily higher dose ( 10 mg ) ramipril observed elsewhere are not found with an eightfold lower daily dose",
"BACKGROUND Whether the treatment of patients with hypertension who are 80 years of age or older is beneficial is unclear . It has been suggested that antihypertensive therapy may reduce the risk of stroke , despite possibly increasing the risk of death . METHODS We r and omly assigned 3845 patients from Europe , China , Australasia , and Tunisia who were 80 years of age or older and had a sustained systolic blood pressure of 160 mm Hg or more to receive either the diuretic indapamide ( sustained release , 1.5 mg ) or matching placebo . The angiotensin-converting-enzyme inhibitor perindopril ( 2 or 4 mg ) , or matching placebo , was added if necessary to achieve the target blood pressure of 150/80 mm Hg . The primary end point was fatal or nonfatal stroke . RESULTS The active-treatment group ( 1933 patients ) and the placebo group ( 1912 patients ) were well matched ( mean age , 83.6 years ; mean blood pressure while sitting , 173.0/90.8 mm Hg ) ; 11.8 % had a history of cardiovascular disease . Median follow-up was 1.8 years . At 2 years , the mean blood pressure while sitting was 15.0/6.1 mm Hg lower in the active-treatment group than in the placebo group . In an intention-to-treat analysis , active treatment was associated with a 30 % reduction in the rate of fatal or nonfatal stroke ( 95 % confidence interval [ CI ] , -1 to 51 ; P=0.06 ) , a 39 % reduction in the rate of death from stroke ( 95 % CI , 1 to 62 ; P=0.05 ) , a 21 % reduction in the rate of death from any cause ( 95 % CI , 4 to 35 ; P=0.02 ) , a 23 % reduction in the rate of death from cardiovascular causes ( 95 % CI , -1 to 40 ; P=0.06 ) , and a 64 % reduction in the rate of heart failure ( 95 % CI , 42 to 78 ; P serious adverse events were reported in the active-treatment group ( 358 , vs. 448 in the placebo group ; P=0.001 ) . CONCLUSIONS The results provide evidence that antihypertensive treatment with indapamide ( sustained release ) , with or without perindopril , in persons 80 years of age or older is beneficial . ( Clinical Trials.gov number , NCT00122811 [ Clinical Trials.gov ] . )",
"CONTEXT Hypertension is a leading cause of end-stage renal disease ( ESRD ) in the United States , with no known treatment to prevent progressive declines leading to ESRD . OBJECTIVE To compare the effects of 2 levels of blood pressure ( BP ) control and 3 antihypertensive drug classes on glomerular filtration rate ( GFR ) decline in hypertension . DESIGN R and omized 3 x 2 factorial trial with enrollment from February 1995 to September 1998 . SETTING AND PARTICIPANTS A total of 1094 African Americans aged 18 to 70 years with hypertensive renal disease ( GFR , 20 - 65 mL/min per 1.73 m(2 ) ) were recruited from 21 clinical centers throughout the United States and followed up for 3 to 6.4 years . INTERVENTIONS Participants were r and omly assigned to 1 of 2 mean arterial pressure goals , 102 to 107 mm Hg ( usual ; n = 554 ) or 92 mm Hg or less ( lower ; n = 540 ) , and to initial treatment with either a beta-blocker ( metoprolol 50 - 200 mg/d ; n = 441 ) , an angiotensin-converting enzyme inhibitor ( ramipril 2.5 - 10 mg/d ; n = 436 ) or a dihydropyridine calcium channel blocker , ( amlodipine 5 - 10 mg/d ; n = 217 ) . Open-label agents were added to achieve the assigned BP goals . MAIN OUTCOME MEASURES Rate of change in GFR ( GFR slope ) ; clinical composite outcome of reduction in GFR by 50 % or more ( or > or = 25 mL/min per 1.73 m2 ) from baseline , ESRD , or death . Three primary treatment comparisons were specified : lower vs usual BP goal ; ramipril vs metoprolol ; and amlodipine vs metoprolol . RESULTS Achieved BP averaged ( SD ) 128/78 ( 12/8 ) mm Hg in the lower BP group and 141/85 ( 12/7 ) mm Hg in the usual BP group . The mean ( SE ) GFR slope from baseline through 4 years did not differ significantly between the lower BP group ( -2.21 [ 0.17 ] mL/min per 1.73 m2 per year ) and the usual BP group ( -1.95 [ 0.17 ] mL/min per 1.73 m2 per year ; P = .24 ) , and the lower BP goal did not significantly reduce the rate of the clinical composite outcome ( risk reduction for lower BP group = 2 % ; 95 % confidence interval [ CI ] , -22 % to 21 % ; P = .85 ) . None of the drug group comparisons showed consistent significant differences in the GFR slope . However , compared with the metoprolol and amlodipine groups , the ramipril group manifested risk reductions in the clinical composite outcome of 22 % ( 95 % CI , 1%-38 % ; P = .04 ) and 38 % ( 95 % CI , 14%-56 % ; P = .004 ) , respectively . There was no significant difference in the clinical composite outcome between the amlodipine and metoprolol groups . CONCLUSIONS No additional benefit of slowing progression of hypertensive nephrosclerosis was observed with the lower BP goal . Angiotensin-converting enzyme inhibitors appear to be more effective than beta-blockers or dihydropyridine calcium channel blockers in slowing GFR decline",
"The pilot study of the Systolic Hypertension in the Elderly Program was a r and omized , double-blind , placebo-controlled trial of drug therapy for isolated systolic hypertension . It followed 551 elderly participants with untreated blood pressures of greater than 160/less than 90 mm Hg for an average of 34 months . Mean age of the participants was 72 years ; 63 % were women , and 82 % were white . Pretreatment blood pressures averaged 172/75 mm Hg . Participants were r and omly assigned to treatment with chlorthalidone or placebo as Step I medication . Blood pressures at annual visits averaged 141/68 and 157/73 mm Hg for the drug-treated and placebo-treated groups , respectively , with 60 % and 33 % of the survivors on blinded medication having systolic blood pressures of less than 160 mm Hg at their last annual visit . All-cause mortality rates for the drug-treated and placebo-treated groups were 25.4 and 22.7 deaths per 1,000 participant-years of risk , and rates for definite \" first stroke \" were 8.3 and 12.8 per 1,000 years of risk . Differences between groups were significant for systolic and diastolic blood pressure but not for death or stroke rates . A full-scale study has begun to determine the effects of drug therapy for isolated systolic hypertension on stroke and mortality rates",
"BACKGROUND Lowering of blood pressure prevents stroke but optimum target levels to prevent recurrent stroke are unknown . We investigated the effects of different blood-pressure targets on the rate of recurrent stroke in patients with recent lacunar stroke . METHODS In this r and omised open-label trial , eligible patients lived in North America , Latin America , and Spain and had recent , MRI-defined symptomatic lacunar infa rct ions . Patients were recruited between March , 2003 , and April , 2011 , and r and omly assigned , according to a two-by-two multifactorial design , to a systolic-blood-pressure target of 130 - 149 mm Hg or less than 130 mm Hg . The primary endpoint was reduction in all stroke ( including ischaemic strokes and intracranial haemorrhages ) . Analysis was done by intention to treat . This study is registered with Clinical Trials.gov , number NCT 00059306 . FINDINGS 3020 enrolled patients , 1519 in the higher-target group and 1501 in the lower-target group , were followed up for a mean of 3·7 ( SD 2·0 ) years . Mean age was 63 ( SD 11 ) years . After 1 year , mean systolic blood pressure was 138 mm Hg ( 95 % CI 137 - 139 ) in the higher-target group and 127 mm Hg ( 95 % CI 126 - 128 ) in the lower-target group . Non-significant rate reductions were seen for all stroke ( hazard ratio 0·81 , 95 % CI 0·64 - 1·03 , p=0·08 ) , disabling or fatal stroke ( 0·81 , 0·53 - 1·23 , p=0·32 ) , and the composite outcome of myocardial infa rct ion or vascular death ( 0·84 , 0·68 - 1·04 , p=0·32 ) with the lower target . The rate of intracerebral haemorrhage was reduced significantly ( 0·37 , 0·15 - 0·95 , p=0·03 ) . Treatment-related serious adverse events were infrequent . INTERPRETATION Although the reduction in stroke was not significant , our results support that in patients with recent lacunar stroke , the use of a systolic-blood-pressure target of less than 130 mm Hg is likely to be beneficial . FUNDING National Institutes of Health-National Institute of Neurological Disorders and Stroke ( NIH-NINDS )",
"BACKGROUND This study was undertaken to determine whether use of the direct renin inhibitor aliskiren would reduce cardiovascular and renal events in patients with type 2 diabetes and chronic kidney disease , cardiovascular disease , or both . METHODS In a double-blind fashion , we r and omly assigned 8561 patients to aliskiren ( 300 mg daily ) or placebo as an adjunct to an angiotensin-converting-enzyme inhibitor or an angiotensin-receptor blocker . The primary end point was a composite of the time to cardiovascular death or a first occurrence of cardiac arrest with resuscitation ; nonfatal myocardial infa rct ion ; nonfatal stroke ; unplanned hospitalization for heart failure ; end-stage renal disease , death attributable to kidney failure , or the need for renal-replacement therapy with no dialysis or transplantation available or initiated ; or doubling of the baseline serum creatinine level . RESULTS The trial was stopped prematurely after the second interim efficacy analysis . After a median follow-up of 32.9 months , the primary end point had occurred in 783 patients ( 18.3 % ) assigned to aliskiren as compared with 732 ( 17.1 % ) assigned to placebo ( hazard ratio , 1.08 ; 95 % confidence interval [ CI ] , 0.98 to 1.20 ; P=0.12 ) . Effects on secondary renal end points were similar . Systolic and diastolic blood pressures were lower with aliskiren ( between-group differences , 1.3 and 0.6 mm Hg , respectively ) and the mean reduction in the urinary albumin-to-creatinine ratio was greater ( between-group difference , 14 percentage points ; 95 % CI , 11 to 17 ) . The proportion of patients with hyperkalemia ( serum potassium level , ≥6 mmol per liter ) was significantly higher in the aliskiren group than in the placebo group ( 11.2 % vs. 7.2 % ) , as was the proportion with reported hypotension ( 12.1 % vs. 8.3 % ) ( P addition of aliskiren to st and ard therapy with renin-angiotensin system blockade in patients with type 2 diabetes who are at high risk for cardiovascular and renal events is not supported by these data and may even be harmful . ( Funded by Novartis ; ALTITUDE Clinical Trials.gov number , NCT00549757 . )",
"BACKGROUND Microalbuminuria is an early predictor of diabetic nephropathy and premature cardiovascular disease . We investigated whether treatment with an angiotensin-receptor blocker ( ARB ) would delay or prevent the occurrence of microalbuminuria in patients with type 2 diabetes and normoalbuminuria . METHODS In a r and omized , double-blind , multicenter , controlled trial , we assigned 4447 patients with type 2 diabetes to receive olmesartan ( at a dose of 40 mg once daily ) or placebo for a median of 3.2 years . Additional antihypertensive drugs ( except angiotensin-converting-enzyme inhibitors or ARBs ) were used as needed to lower blood pressure to less than 130/80 mm Hg . The primary outcome was the time to the first onset of microalbuminuria . The times to the onset of renal and cardiovascular events were analyzed as secondary end points . RESULTS The target blood pressure ( olmesartan and 71 % taking placebo ; blood pressure measured in the clinic was lower by 3.1/1.9 mm Hg in the olmesartan group than in the placebo group . Microalbuminuria developed in 8.2 % of the patients in the olmesartan group ( 178 of 2160 patients who could be evaluated ) and 9.8 % in the placebo group ( 210 of 2139 ) ; the time to the onset of microalbuminuria was increased by 23 % with olmesartan ( hazard ratio for onset of microalbuminuria , 0.77 ; 95 % confidence interval , 0.63 to 0.94 ; P=0.01 ) . The serum creatinine level doubled in 1 % of the patients in each group . Slightly fewer patients in the olmesartan group than in the placebo group had nonfatal cardiovascular events--81 of 2232 patients ( 3.6 % ) as compared with 91 of 2215 patients ( 4.1 % ) (P=0.37)--but a greater number had fatal cardiovascular events--15 patients ( 0.7 % ) as compared with 3 patients ( 0.1 % ) ( P=0.01 ) , a difference that was attributable in part to a higher rate of death from cardiovascular causes in the olmesartan group than in the placebo group among patients with preexisting coronary heart disease ( 11 of 564 patients [ 2.0 % ] vs. 1 of 540 [ 0.2 % ] , P=0.02 ) . CONCLUSIONS Olmesartan was associated with a delayed onset of microalbuminuria , even though blood-pressure control in both groups was excellent according to current st and ards . The higher rate of fatal cardiovascular events with olmesartan among patients with preexisting coronary heart disease is of concern . ( Funded by Daiichi Sankyo ; Clinical Trials.gov number , NCT00185159 . )",
"BACKGROUND It is not known whether drugs that block the renin-angiotensin system reduce the risk of diabetes and cardiovascular events in patients with impaired glucose tolerance . METHODS In this double-blind , r and omized clinical trial with a 2-by-2 factorial design , we assigned 9306 patients with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors to receive valsartan ( up to 160 mg daily ) or placebo ( and nateglinide or placebo ) in addition to lifestyle modification . We then followed the patients for a median of 5.0 years for the development of diabetes ( 6.5 years for vital status ) . We studied the effects of valsartan on the occurrence of three co primary outcomes : the development of diabetes ; an extended composite outcome of death from cardiovascular causes , nonfatal myocardial infa rct ion , nonfatal stroke , hospitalization for heart failure , arterial revascularization , or hospitalization for unstable angina ; and a core composite outcome that excluded unstable angina and revascularization . RESULTS The cumulative incidence of diabetes was 33.1 % in the valsartan group , as compared with 36.8 % in the placebo group ( hazard ratio in the valsartan group , 0.86 ; 95 % confidence interval [ CI ] , 0.80 to 0.92 ; P Valsartan , as compared with placebo , did not significantly reduce the incidence of either the extended cardiovascular outcome ( 14.5 % vs. 14.8 % ; hazard ratio , 0.96 ; 95 % CI , 0.86 to 1.07 ; P=0.43 ) or the core cardiovascular outcome ( 8.1 % vs. 8.1 % ; hazard ratio , 0.99 ; 95 % CI , 0.86 to 1.14 ; P=0.85 ) . CONCLUSIONS Among patients with impaired glucose tolerance and cardiovascular disease or risk factors , the use of valsartan for 5 years , along with lifestyle modification , led to a relative reduction of 14 % in the incidence of diabetes but did not reduce the rate of cardiovascular events . ( Clinical Trials.gov number , NCT00097786 .",
"OBJECTIVES The primary objective of this study was to investigate the effects of the angiotensin-converting enzyme ( ACE ) inhibitor , ramipril , on carotid atherosclerosis in patients with coronary , cerebrovascular or peripheral vascular disease . BACKGROUND Angiotensin-converting enzyme inhibitors have been shown to reduce the risk of coronary events in various patient groups and to prevent the development of atherosclerosis in animal models . It has been hypothesized that the clinical benefits of ACE inhibitors may , therefore , be mediated by effects on atherosclerosis . METHODS Six hundred seventeen patients were r and omized in equal proportions to ramipril ( 5 - 10 mg daily ) or placebo . At baseline , two years and four years , carotid atherosclerosis was assessed by B-mode ultrasound , and left ventricular mass was assessed by M-mode echocardiography . RESULTS Blood pressure ( BP ) was reduced by a mean of 6 mm Hg systolic and 4 mm Hg diastolic in the ramipril group compared with the placebo group ( p common carotid artery wall thickness ( p = 0.58 ) or in carotid plaque ( p = 0.93 ) . Left ventricular mass index decreased by 3.8 g/m2 ( 4 % ) in the ramipril group compared with the placebo group ( 2p = 0.04 ) . CONCLUSIONS The results provide no support for the hypothesis that reduced atherosclerosis is responsible for the beneficial effects of ACE inhibitors on major coronary events . It is more likely that the benefits are due to lower BP , reduced left ventricular mass or other factors such as reversal of endothelial dysfunction",
"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",
"BACKGROUND Angiotensin-converting-enzyme inhibitors improve the outcome among patients with left ventricular dysfunction , whether or not they have heart failure . We assessed the role of an angiotensin-converting-enzyme inhibitor , ramipril , in patients who were at high risk for cardiovascular events but who did not have left ventricular dysfunction or heart failure . METHODS A total of 9297 high-risk patients ( 55 years of age or older ) who had evidence of vascular disease or diabetes plus one other cardiovascular risk factor and who were not known to have a low ejection fraction or heart failure were r and omly assigned to receive ramipril ( 10 mg once per day orally ) or matching placebo for a mean of five years . The primary outcome was a composite of myocardial infa rct ion , stroke , or death from cardiovascular causes . The trial was a two-by-two factorial study evaluating both ramipril and vitamin E. The effects of vitamin E are reported in a companion paper . RESULTS A total of 651 patients who were assigned to receive ramipril ( 14.0 percent ) reached the primary end point , as compared with 826 patients who were assigned to receive placebo ( 17.8 percent ) ( relative risk , 0.78 ; 95 percent confidence interval , 0.70 to 0.86 ; P rates of death from cardiovascular causes ( 6.1 percent , as compared with 8.1 percent in the placebo group ; relative risk , 0.74 ; P myocardial infa rct ion ( 9.9 percent vs. 12.3 percent ; relative risk , 0.80 ; P stroke ( 3.4 percent vs. 4.9 percent ; relative risk , 0.68 ; P death from any cause ( 10.4 percent vs. 12.2 percent ; relative risk , 0.84 ; P=0.005 ) , revascularization procedures ( 16.3 percent vs. 18.8 percent ; relative risk , 0.85 ; P cardiac arrest ( 0.8 percent vs. 1.3 percent ; relative risk , 0.62 ; P=0.02 ) , [ corrected ] heart failure ( 9.1 percent vs. 11.6 percent ; relative risk , 0.77 ; P complications related to diabetes ( 6.4 percent vs. 7.6 percent ; relative risk , 0.84 ; P=0.03 ) . CONCLUSIONS Ramipril significantly reduces the rates of death , myocardial infa rct ion , and stroke in a broad range of high-risk patients who are not known to have a low ejection fraction or heart failure",
"This study was performed to investigate whether intensive antihypertensive treatment with achieved blood pressure ( BP ) ≤140/90 mm Hg , as compared with st and ard treatment with achieved BP ≤150/90 mm Hg , could further improve cardiovascular outcomes in Chinese hypertensive patients older than 70 years . A total of 724 participants were r and omly assigned to intensive or st and ard antihypertensive treatment . After a mean follow-up of 4 years , the mean achieved BP was 135.7/76.2 mm Hg in the intensive treatment group and 149.7/82.1 mm Hg in the st and ard treatment group . The visit-to-visit variability in systolic BP and diastolic BP was lower in the intensive group than that in the st and ard group . Intensive antihypertensive treatment , compared with the st and ard treatment , decreased total and cardiovascular mortality by 41.7 % and 50.3 % , respectively , and reduced fatal/nonfatal stroke by 42.0 % and heart failure death by 62.7 % . Cox regression analysis indicated that the mean systolic BP ( P=.020 ; 95 % confidence interval , 1.006 - 1.069 ) and the st and ard deviation of systolic BP ( P=.033 ; 95 % confidence interval , 1.006 - 1.151 ) were risk factors for cardiovascular endpoint events . Intensive antihypertensive treatment with achieved 136/76 mm Hg was beneficial for Chinese hypertensive patients older than 70 years . Long-term visit-to-visit variability in systolic BP was positively associated with the incidence of cardiovascular events",
"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",
"BACKGROUND Previous trials have shown that the use of statins to lower cholesterol reduces the risk of cardiovascular events among persons without cardiovascular disease . Those trials have involved persons with elevated lipid levels or inflammatory markers and involved mainly white persons . It is unclear whether the benefits of statins can be extended to an intermediate-risk , ethnically diverse population without cardiovascular disease . METHODS In one comparison from a 2-by-2 factorial trial , we r and omly assigned 12,705 participants in 21 countries who did not have cardiovascular disease and were at intermediate risk to receive rosuvastatin at a dose of 10 mg per day or placebo . The first co primary outcome was the composite of death from cardiovascular causes , nonfatal myocardial infa rct ion , or nonfatal stroke , and the second co primary outcome additionally included revascularization , heart failure , and resuscitated cardiac arrest . The median follow-up was 5.6 years . RESULTS The overall mean low-density lipoprotein cholesterol level was 26.5 % lower in the rosuvastatin group than in the placebo group . The first co primary outcome occurred in 235 participants ( 3.7 % ) in the rosuvastatin group and in 304 participants ( 4.8 % ) in the placebo group ( hazard ratio , 0.76 ; 95 % confidence interval [ CI ] , 0.64 to 0.91 ; P=0.002 ) . The results for the second co primary outcome were consistent with the results for the first ( occurring in 277 participants [ 4.4 % ] in the rosuvastatin group and in 363 participants [ 5.7 % ] in the placebo group ; hazard ratio , 0.75 ; 95 % CI , 0.64 to 0.88 ; P cardiovascular risk at baseline , lipid level , C-reactive protein level , blood pressure , and race or ethnic group . In the rosuvastatin group , there was no excess of diabetes or cancers , but there was an excess of cataract surgery ( in 3.8 % of the participants , vs. 3.1 % in the placebo group ; P=0.02 ) and muscle symptoms ( in 5.8 % of the participants , vs. 4.7 % in the placebo group ; P=0.005 ) . CONCLUSIONS Treatment with rosuvastatin at a dose of 10 mg per day result ed in a significantly lower risk of cardiovascular events than placebo in an intermediate-risk , ethnically diverse population without cardiovascular disease . ( Funded by the Canadian Institutes of Health Research and AstraZeneca ; HOPE-3 Clinical Trials.gov number , NCT00468923 . )",
"Angiotensin-converting enzyme inhibitors improve endothelial function , inhibit experimental atherogenesis , and decrease ischemic events . The Quinapril Ischemic Event Trial was design ed to test the hypothesis that quinapril 20 mg/day would reduce ischemic events ( the occurrence of cardiac death , resuscitated cardiac arrest , nonfatal myocardial infa rct ion , coronary artery bypass grafting , coronary angioplasty , or hospitalization for angina pectoris ) and the angiographic progression of coronary artery disease in patients without systolic left ventricular dysfunction . A total of 1,750 patients were r and omized to quinapril 20 mg/day or placebo and followed a mean of 27 + /- 0.3 months . The 38 % incidence of ischemic events was similar for both groups ( RR 1.04 ; 95 % confidence interval 0.89 to 1.22 ; p = 0.6 ) . There was also no significant difference in the incidence of patients having angiographic progression of coronary disease ( p = 0.71 ) . The rate of development of new coronary lesions was also similar in both groups ( p = 0.35 ) . However , there was a difference in the incidence of angioplasty for new ( previously unintervened ) vessels ( p = 0.018 ) . Quinapril was well tolerated in patients after angioplasty with normal left ventricular function . Quinapril 20 mg did not significantly affect the overall frequency of clinical outcomes or the progression of coronary atherosclerosis . However , the absence of the demonstrable effect of quinapril may be due to several limitations in study design",
"OBJECTIVE To compare six antihypertensive interventions for the treatment of mild hypertension . DESIGN R and omized , double-blind , placebo-controlled clinical trial . SETTING Four hypertension screening and treatment centers in the United States . PARTICIPANTS Hypertensive men and women , aged 45 to 69 years , with diastolic blood pressure less than 100 mm Hg . INTERVENTION Sustained nutritional-hygienic advice to all participants to reduce weight , dietary sodium intake , and alcohol intake , and increase physical activity . Participants were r and omly allocated to take ( 1 ) placebo ( n = 234 ) ; ( 2 ) chlorthalidone ( n = 136 ) ; ( 3 ) acebutolol ( n = 132 ) ; ( 4 ) doxazosin mesylate ( n = 134 ) ; ( 5 ) amlodipine maleate ( n = 131 ) ; or ( 6 ) enalapril maleate ( n = 135 ) . MAIN OUTCOME MEASURES Blood pressure , quality of life , side effects , blood lipid levels and analysis of other serum components , echocardiographic and electrocardiographic changes , and incidence of cardiovascular events over an average of 4.4 years of follow-up . RESULTS Blood pressure reductions were sizable in all six groups , and were significantly greater for participants assigned to drug treatment than placebo ( -15.9 vs -9.1 mm Hg for systolic blood pressure and -12.3 vs -8.6 mm Hg for diastolic blood pressure ; P died or experienced a major nonfatal cardiovascular event than those assigned to the placebo group ( 5.1 % vs 7.3 % ; P = .21 ) . After including other clinical events , the percentage of participants affected was 11.1 % for those in the drug-treatment groups and 16.2 % for those in the placebo group ( P = .03 ) . Incidence rates of most resting electrocardiographic abnormalities were lower and quality of life was improved more for those assigned to drug-treatment groups rather than the placebo group . Differences among the five drug treatments did not consistently favor one group in terms of regression of left ventricular mass , blood lipid levels , and other outcome measures . CONCLUSIONS As an initial regimen , drug treatment in combination with nutritional-hygienic intervention was more effective in preventing cardiovascular and other clinical events than was nutritional-hygienic treatment alone . Drug-treatment group differences were minimal . Pending results from large-scale clinical trials to evaluate drug treatments for their effect on cardiovascular clinical events , these findings support the recommendations of the new fifth Joint National Committee report regarding treatment choices for people with stage 1 ( \" mild \" ) hypertension",
"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",
"BACKGROUND Treatment with angiotensin-converting-enzyme ( ACE ) inhibitors reduces the rate of cardiovascular events among patients with left-ventricular dysfunction and those at high risk of such events . We assessed whether the ACE inhibitor perindopril reduced cardiovascular risk in a low-risk population with stable coronary heart disease and no apparent heart failure . METHODS We recruited patients from October , 1997 , to June , 2000 . 13655 patients were registered with previous myocardial infa rct ion ( 64 % ) , angiographic evidence of coronary artery disease ( 61 % ) , coronary revascularisation ( 55 % ) , or a positive stress test only ( 5 % ) . After a run-in period of 4 weeks , in which all patients received perindopril , 12218 patients were r and omly assigned perindopril 8 mg once daily ( n=6110 ) , or matching placebo ( n=6108 ) . The mean follow-up was 4.2 years , and the primary endpoint was cardiovascular death , myocardial infa rct ion , or cardiac arrest . Analysis was by intention to treat . FINDINGS Mean age of patients was 60 years ( SD 9 ) , 85 % were male , 92 % were taking platelet inhibitors , 62 % beta blockers , and 58 % lipid-lowering therapy . 603 ( 10 % ) placebo and 488 ( 8 % ) perindopril patients experienced the primary endpoint , which yields a 20 % relative risk reduction ( 95 % CI 9 - 29 , p=0.0003 ) with perindopril . These benefits were consistent in all predefined subgroups and secondary endpoints . Perindopril was well tolerated . INTERPRETATION Among patients with stable coronary heart disease without apparent heart failure , perindopril can significantly improve outcome . About 50 patients need to be treated for a period of 4 years to prevent one major cardiovascular event . Treatment with perindopril , on top of other preventive medications , should be considered in all patients with coronary heart disease",
"BACKGROUND Microalbuminuria and hypertension are risk factors for diabetic nephropathy . Blockade of the renin-angiotensin system slows the progression to diabetic nephropathy in patients with type 1 diabetes , but similar data are lacking for hypertensive patients with type 2 diabetes . We evaluated the renoprotective effect of the angiotensin-II-receptor antagonist irbesartan in hypertensive patients with type 2 diabetes and microalbuminuria . METHODS A total of 590 hypertensive patients with type 2 diabetes and microalbuminuria were enrolled in this multinational , r and omized , double-blind , placebo-controlled study of irbesartan , at a dose of either 150 mg daily or 300 mg daily , and were followed for two years . The primary outcome was the time to the onset of diabetic nephropathy , defined by persistent albuminuria in overnight specimens , with a urinary albumin excretion rate that was greater than 200 microg per minute and at least 30 percent higher than the base-line level . RESULTS The base-line characteristics in the three groups were similar . Ten of the 194 patients in the 300-mg group ( 5.2 percent ) and 19 of the 195 patients in the 150-mg group ( 9.7 percent ) reached the primary end point , as compared with 30 of the 201 patients in the placebo group ( 14.9 percent ) ( hazard ratios , 0.30 [ 95 percent confidence interval , 0.14 to 0.61 ; P average blood pressure during the course of the study was 144/83 mm Hg in the placebo group , 143/83 mm Hg in the 150-mg group , and 141/83 mm Hg in the 300-mg group ( P=0.004 for the comparison of systolic blood pressure between the placebo group and the combined irbesartan groups ) . Serious adverse events were less frequent among the patients treated with irbesartan ( P=0.02 ) . CONCLUSIONS Irbesartan is renoprotective independently of its blood-pressure-lowering effect in patients with type 2 diabetes and microalbuminuria",
"BACKGROUND Angiotensin-converting-enzyme ( ACE ) inhibitors are effective in reducing the risk of heart failure , myocardial infa rct ion , and death from cardiovascular causes in patients with left ventricular systolic dysfunction or heart failure . ACE inhibitors have also been shown to reduce atherosclerotic complications in patients who have vascular disease without heart failure . METHODS In the Prevention of Events with Angiotensin Converting Enzyme Inhibition ( PEACE ) Trial , we tested the hypothesis that patients with stable coronary artery disease and normal or slightly reduced left ventricular function derive therapeutic benefit from the addition of ACE inhibitors to modern conventional therapy . The trial was a double-blind , placebo-controlled study in which 8290 patients were r and omly assigned to receive either tr and olapril at a target dose of 4 mg per day ( 4158 patients ) or matching placebo ( 4132 patients ) . RESULTS The mean ( + /-SD ) age of the patients was 64+/-8 years , the mean blood pressure 133+/-17/78+/-10 mm Hg , and the mean left ventricular ejection fraction 58+/-9 percent . The patients received intensive treatment , with 72 percent having previously undergone coronary revascularization and 70 percent receiving lipid-lowering drugs . The incidence of the primary end point -- death from cardiovascular causes , myocardial infa rct ion , or coronary revascularization -- was 21.9 percent in the tr and olapril group , as compared with 22.5 percent in the placebo group ( hazard ratio in the tr and olapril group , 0.96 ; 95 percent confidence interval , 0.88 to 1.06 ; P=0.43 ) over a median follow-up period of 4.8 years . CONCLUSIONS In patients with stable coronary heart disease and preserved left ventricular function who are receiving \" current st and ard \" therapy and in whom the rate of cardiovascular events is lower than in previous trials of ACE inhibitors in patients with vascular disease , there is no evidence that the addition of an ACE inhibitor provides further benefit in terms of death from cardiovascular causes , myocardial infa rct ion , or coronary revascularization",
"The benefits of lowering a systolic blood pressure below 140 mmHg in elderly hypertension remain controversial . This study is a prospect i ve , r and omized , open-label study with blinded assessment of endpoints to compare the 2-year effect of strict treatment to maintain systolic blood pressure below 140 mmHg with that of mild treatment to maintain systolic blood pressure below 160 but at or above 140 mmHg in elderly hypertensive patients . Patients with essential hypertension ( 65–85 years old , with a pretreatment systolic blood pressure of above 160 mmHg ) were r and omly assigned to receive strict treatment ( n=2,212 ) or mild treatment ( n=2,206 ) . The baseline drug was efonidipine hydrochloride , a long-acting calcium antagonist . The primary endpoint was the combined incidence of cardiovascular disease and renal failure , and the secondary endpoints were total deaths and any safety problems . Although final blood pressures ( systolic/diastolic ) were significantly lower in the strict-treatment group compared with the mild-treatment group ( 135.9/74.8 vs. 145.6/78.1 mmHg ; p ) . Total deaths were 54 in the strict-treatment group vs. 42 in the mild-treatment group ( p=0.22 ) , and treatment was withdrawn because of adverse events in 36 patients in each group ( p=0.99 ) . An interaction between age and treatment for the primary endpoints ( p=0.03 ) was seen . Complex clinical features associated with aging seem to have obscured the difference in effect between the two treatments . Further studies are needed to assess the optimal treatment strategy for hypertension in the elderly",
"A r and omised trial of the treatment of hypertension in 884 patients aged 60 to 79 years at the onset showed a reduction of 18/11 mm Hg in blood pressure over a mean follow up period of 4.4 years . The principal antihypertensive agents were atenolol and bendrofluazide . There was a reduction in the rate of fatal stroke in the treatment group to 30 % of that in the control group ( 95 % confidence interval 11 - 84 % , p less than 0.025 ) . The rate of all strokes ( fatal and non-fatal ) in the treatment group was 58 % of that in the control group ( 95 % confidence interval 35 - 96 % , p less than 0.03 ) . The incidence of myocardial infa rct ion and total mortality was unaffected by treatment . Question naires completed by the patients and their relatives failed to identify any differences in symptoms that were likely to be due to treatment",
"In 1972 - -1973 , 785 symptom-free men , aged 40 to 49 years , without target organ damage , with systolic blood pressures between 150 and 179 mm Hg and diastolic blood pressure below 110 mm Hg , were assigned at r and om to one of two groups : ( 406 to a drug treatment group and 379 to a control group ) for a five-year controlled drug treatment trial to evaluate the effect of therapy on cardiovascular complications . Drug treatment started with hydrochlorothiazide . If systolic blood pressure remained above 140 mm Hg and /or diastolic blood pressure above 90 mm Hg , alphamethyldopa was added . If there were side effects , methyldopa was replaced with propranolol . The control group was not given a placebo . The mean observation time was 66 months ( range 60 to 78 months ) . A difference in blood pressure between groups of about 17 mm Hg systolic and 10 mm Hg diastolic was maintained throughout the study . The study protocol had a rather low \" ethical \" blood pressure roof , 180 mm Hg systolic and /or 110 mm Hg diastolic . Seventeen percent of the control group had an increase in blood pressure above this level during the trial , and drug treatment was started . There was no effect on major cardiovascular morbidity comparing groups as established by r and omization , with 18 events in the treatment group and 20 events in the control group . There was no difference between the groups in total mortality and mortality from cardiovascular events . However , in the subgroups with diastolic blood pressure greater than or equal to 100 mm Hg before r and omization , there was a probable reduction in total morbidity from cardiovascular events in favor or the group receiving drug therapy , 7.6 and 16.4 percent events in the treated and control groups , respectively . Cerebrovascular events occurred only in the control group , 7 versus 0 . Two cases of fatal aortic aneurysms also occurred in the control group . Other \" pressure \" complications , such as marked left ventricular hypertrophy in the electrocardiogram and left ventricular failure , occurred only in the control group . However , regarding coronary heart disease , including sudden death , the incidence tended to be higher in the treated group , although it was not statistically significant . Only 13 men ( 1.7 percent ) failed to meet for regular examinations . At the end of the study these men were also followed up with regard to possible cardiovascular events",
"Abstract Aims /hypothesisThe renal and cardiovascular protective effects of angiotensin receptor blocker ( ARB ) remain controversial in type 2 diabetic patients treated with a contemporary regimen including an angiotensin converting enzyme inhibitor ( ACEI ) . Methods We examined the effects of olmesartan , an ARB , on primary composite outcome of doubling of serum creatinine , endstage renal disease and death in type 2 diabetic patients with overt nephropathy . Secondary outcome included composite cardiovascular outcomes , changes in renal function and proteinuria . R and omisation and allocation to trial group were carried out by a central computer system . Participants , caregivers , the people carrying out examinations and people assessing the outcomes were blinded to group assignment . Results Five hundred and seventy-seven ( 377 Japanese , 200 Chinese ) patients treated with antihypertensive therapy ( 73.5 % [ n = 424 ] received concomitant ACEI ) , were given either once-daily olmesartan ( 10–40 mg ) ( n = 288 ) or placebo ( n = 289 ) over 3.2 ± 0.6 years ( mean±SD ) . In the olmesartan group , 116 developed the primary outcome ( 41.1 % ) compared with 129 ( 45.4 % ) in the placebo group ( HR 0.97 , 95 % CI 0.75 , 1.24 ; p = 0.791 ) . Olmesartan significantly decreased blood pressure , proteinuria and rate of change of reciprocal serum creatinine . Cardiovascular death was higher in the olmesartan group than the placebo group ( ten vs three cases ) , whereas major adverse cardiovascular events ( cardiovascular death plus non-fatal stroke and myocardial infa rct ion ) and all-cause death were similar between the two groups ( major adverse cardiovascular events 18 vs 21 cases , all-cause deaths ; 19 vs 20 cases ) . Hyperkalaemia was more frequent in the olmesartan group than the placebo group ( 9.2 % vs 5.3 % ) . Conclusions /interpretationOlmesartan was well tolerated but did not improve renal outcome on top of ACEI . Trial registration : Clinical Trials.gov NCT00141453 Funding : The ORIENT study was supported by a research grant from Daiichi Sankyo",
"OBJECTIVE --To establish whether treatment with diuretic or beta blocker in hypertensive older adults reduces risk of stroke , coronary heart disease , and death . DESIGN --R and omised , placebo controlled , single blind trial . SETTING --226 general practice s in the MRC general practice research framework . SUBJECTS--4396 patients aged 65 - 74 r and omised to receive diuretic , beta blocker , or placebo . Patients had mean systolic pressures of 160 - 209 mm Hg and mean diastolic pressures less than 115 mm Hg during an eight week run in and were not taking antihypertensive treatment . INTERVENTION-- Patients were r and omised to atenolol 50 mg daily ; hydrochlorothiazide 25 mg or 50 mg plus amiloride 2.5 mg or 5 mg daily ; or placebo . The regimens were adjusted to achieve specified target pressures . Mean follow up was 5.8 years . MAIN OUTCOME MEASURES --Strokes , coronary events , and deaths from all causes . RESULTS --Both treatments reduced blood pressure below the level in the placebo group . Compared with the placebo group , actively treated subjects ( diuretic and beta blocker groups combined ) had a 25 % ( 95 % confidence interval 3 % to 42 % ) reduction in stroke ( p = 0.04 ) , 19 % ( -2 % to 36 % ) reduction in coronary events ( p = 0.08 ) , and 17 % ( 2 % to 29 % ) reduction in all cardiovascular events ( p = 0.03 ) . After adjusting for baseline characteristics the diuretic group had significantly reduced risks of stroke ( 31 % ( 3 % to 51 % ) p = 0.04 ) , coronary events ( 44 % ( 21 % to 60 % ) , p = 0.0009 ) , and all cardiovascular events ( 35 % ( 17 % to 49 % ) , p = 0.0005 ) compared with the placebo group . The beta blocker group showed no significant reductions in these end points . The reduction in strokes was mainly in non-smokers taking the diuretic . CONCLUSION --Hydrochlorothiazide and amiloride reduce the risk of stroke , coronary events , and all cardiovascular events in older hypertensive adults ",
"The concept of microalbuminuria has had a major impact on diabetes research and clinical care of patients with diabetes [ 1 - 5 ] . Initial albuminuria is regarded by most research ers as an independent predictor of subsequent progression of nephropathy and risk for cardiovascular morbidity and mortality [ 6 - 8 ] . Angiotensin-converting enzyme ( ACE ) inhibitors have been found to attenuate progression of nephropathy in both types of diabetes in hypertensive [ 9 - 12 ] and normotensive patients [ 13 - 15 ] with microalbuminuria . They were also found to lower urinary albumin excretion in normotensive and normoalbuminuric patients with type 1 diabetes [ 16 ] . The relation between albuminuria and later progression of nephropathy in these patients has not been established , possibly because of short follow-up periods . No data are available on the effect of early introduction of ACE inhibitors in normotensive and normoalbuminuric patients with type 2 diabetes mellitus . We design ed a r and omized , double-blind , placebo-controlled trial of the effect of ACE inhibition on the course of nephropathy in 156 patients with type 2 diabetes . These patients had normal blood pressure and normal urinary albumin excretion at baseline . Methods Patients Potential c and i date s were identified through the computerized records of the central regional laboratory for the northern part of the greater Tel-Aviv area . Persons with hyperglycemia and normal urinalysis results were located through their family physicians . Consent was sought once eligibility was established . Inclusion criteria were age younger than 60 years ; age 40 years or older at diagnosis ; duration of diabetes mellitus less than 10 years with no clinical evidence of malignant , autoimmune , hepatic , cardiovascular , or renal disease ; body mass index less than 30 kg/m2 ; normal blood pressure on at least two consecutive visits ( systolic pressure 140 mm Hg and diastolic pressure 90 mm Hg ; mean pressure 107 mm Hg ) ; serum creatinine concentration of 123 mol/L or less ; and urinary albumin excretion of 30 mg/24 h or less . All baseline data were obtained twice during the run-in prer and omization period . Patients were eligible only if values within the predetermined range were found on both examinations . The average of the values was used as the baseline value . A total of 255 patients who had type 2 diabetes according to World Health Organization criteria [ 17 ] and attended one of eight clinics in the greater Tel-Aviv area were found to be eligible and were contacted during 1990 and 1991 . Of these patients , 214 gave informed consent to participate . Twenty patients were excluded during the observation period : Six had blood pressure values above normal , 5 had microalbuminuria , 3 had serum creatinine concentrations above the trial criterion , 1 patient developed unstable angina pectoris , and 5 withdrew consent . Of the 194 patients included in the study , 102 were women and 92 were men ( mean age SD , 54.9 3.2 years [ range , 37 to 59 years ] ) . The known duration of diabetes was 0 to 9 years ( mean duration , 5.75 2.8 years ) . Patients were instructed to use the st and ard isocaloric diet recommended by the Israeli Diabetic Association , and 69 study patients used diet alone to control their hyperglycemia . Pharmacologic therapy for diabetes was insulin in 34 patients and oral hypoglycemic agents in 91 patients . Protocol The protocol was approved by the hospital review board . After a 2-month observation period , patients were r and omly assigned in a double-blind manner to receive enalapril ( Assia-Riezel Ltd. , Ramat-Gan , Israel ) , 10 mg/d , or placebo . Ninety-seven patients were assigned to receive enalapril , and 97 were assigned to receive placebo . R and omization was done central ly by telephone with a r and om number table [ 18 ] . Patient allocation to placebo or enalapril was recorded and kept by one of the authors . The placebo tablets were similar in appearance to the enalapril tablets . The medications , which came in sealed , numbered packages , were central ly prepared and were given to the patients at each visit by one nurse who was otherwise not involved in the study . Patients were followed by their family physicians , who were unaware of allocation . Two semiannual prescheduled visits took place each year , and interim visits were scheduled as clinical ly indicated . At the semiannual visits , hemoglobin A1c values , serum creatinine concentrations , serum electrolyte levels , and 24-hour albumin excretion and urinary creatinine concentrations were measured . Blood pressure was measured by the physicians twice at each visit by using mercury sphygmomanometers with the patients seated after a 5-minute rest ; physicians recorded the average of the two values . The diastolic pressure was determined at Korotkoff phase V. If a systolic blood pressure of 145 mm Hg or more or a diastolic blood pressure of 95 mm Hg or more was found , measurements were repeated weekly . If elevated values persisted on two consecutive visits , a long-acting calcium-channel blocker ( diltiazem or verapamil ) , hydrochlorothiazide , or both were administered . If systolic blood pressure values of 100 mm Hg or less were repeatedly found , the enalapril dosage was reduced to 5 mg/d ( half of a 10-mg enalapril tablet or half of a placebo tablet ) . Fundoscopy was done yearly by an ophthalmologist , and the presence of retinopathy was recorded . For each patient , follow-up was terminated 6 years after r and omization . Measurements All blood and urine sample s were examined by a central laboratory . Assays were not changed during the study period . Glycosylated hemoglobin values were measured by affinity chromatography with a commercial kit ( Isolab , Biochemical Methodology , Akron , Ohio ) . The normal range of this assay is a hemoglobin A1c value of 3.5 % to 5.6 % and an intra-assay and interassay coefficient of variability of less than 3 % . Urinary albumin concentration was measured twice in 24-hour urine sample s by an automated immunoturbidimetric method [ 19 ] . This procedure has intra-assay and interassay coefficients of variability of 5.9 % and 7.6 % , respectively . Creatinine concentrations were determined by using the automated method of Bartels and colleagues [ 20 ] . Creatinine clearance , normalized for 1.73 m2 of body surface area , was calculated for each visit by using the st and ard formula ( urine creatinine x urine volume/plasma creatinine ) . The mean blood pressure ( defined as the diastolic pressure plus one third of the pulse pressure ) was calculated at each visit . Statistical Analysis Data are expressed as the mean ( SD ) with ranges . A P value less than 0.05 was considered significant . On the basis of the assumptions that 15 % of normotensive , normoalbuminuric patients with type 2 diabetes will develop microalbuminuria during 6 years and that treatment with enalapril will reduce the risk for microalbuminuria by 12 % , we calculated that 69 patients were required in each group for a type 1 error of 0.05 and a power of 0.80 [ 21 ] . To test for adequate r and omization and to compare the patients who completed the trial with those who did not complete the trial , the enalapril and placebo groups and the 38 patients who dropped out were compared for mean age ; mean duration of diabetes ; and mean baseline albumin excretion , creatinine clearance , glycosylated hemoglobin value , and blood pressure by using pooled-variance Student t-tests for independent groups and one-way analysis of variance . To compare the annual means of the various measurements between the two groups and within each group , one between-group factor and one repeated- measures factor were used in analysis of variance . For variables shown to be different by analysis of variance , unpaired t-tests were used for between-group parallel annual means and paired t-tests were used for comparison of intragroup sequential annual means . The rate of decrease of creatinine clearance and the rate of increase of albumin excretion were computed by doing linear regression analysis with all of the semiannual values included in the equation . Urinary albumin values were logarithmically transformed before analysis . The degree of albuminuria at baseline was used as a covariate . The funding source had no involvement in the design , conduct , or reporting of the trial . Results Figure 1 shows the flow of participants during the trial . Thirty-eight patients did not complete the trial . Five patients died ( 3 in the enalapril group and 2 in the placebo group ) ; death was related to coronary heart disease in 3 patients , stroke in 1 patient , and ovarian carcinoma in 1 patient . Six patients violated the protocol ( 2 patients in the enalapril group stopped taking their medication for more than 6 months , and 4 patients in the placebo group took an ACE inhibitor prescribed by consultant physicians for more than 6 months ) . Ten patients were lost to follow-up ( 6 in the enalapril group and 4 in the placebo group ) . The trial medication was discontinued in 12 patients : Six developed a disturbing cough ( 4 in the enalapril group and 2 in the placebo group ) , 4 had an allergic skin reaction ( 2 in the enalapril group and 2 in the placebo group ) , 1 patient in the enalapril group developed leukopenia , and 1 patient in the placebo group developed hyperkalemia . Finally , 5 patients developed severe urinary tract infections that had a detectable influence on renal function ( 2 in the enalapril group and 3 in the placebo group ) . A total of 156 patients completed the trial , of whom 77 received enalapril and 79 received placebo . Figure 1 . Flow of participants through the trial . Baseline data for the two groups and for patients who did not complete the trial are shown in Table 1 . The baseline characteristics of patients in the study groups and those who dropped out did not differ significantly . A modest but steady decrease in hemoglobin A1c values was seen in the enalapril and the placebo groups and may reflect the change in attitude toward glucose control among family physicians in the early 1990s . However ,",
"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",
"Objectives To address whether nondihydropyridine calcium-channel blocker added-on angiotensin-converting-enzyme inhibitor therapy ameliorates albuminuria and cardiovascular outcomes in type 2 diabetes patients . Design The Bergamo Nephrologic Diabetes Complications Trial-B was a multicentre , prospect i ve , double-blind , parallel-group trial comparing renal and cardiovascular outcomes in 281 hypertensive type 2 diabetes patients with microalbuminuria r and omized to at least 2-year VeraTran ( verapamil/tr and olapril 180 mg/2 mg daily ) or tr and olapril ( 2 mg daily , identical image ) treatment . Main outcome was persistent macroalbuminuria ( albuminuria > 200 μg/min in two consecutive visits ) . Treatment targets were SBP/DBP less than 120/80 mmHg and HbA1C less than 7 % . Results Over a median follow-up of 4.5 years , 18 patients ( 13 % ) on VeraTran vs. 15 ( 10.5 % ) on tr and olapril [ unadjusted hazard ratio ( 95 % confidence interval [ CI ] ) 1.07 ( 0.54–2.12 ) , P = 0.852 ] progressed to macroalbuminuria , respectively ; 62 ( 44.9 % ) vs. 71 ( 49.7 % ) [ 0.80 ( 0.57–1.12 ) , P = 0.198 ] regressed to normoalbuminuria ( urinary albumin excretion had major cardiovascular events . BP and metabolic control were similar between groups . Patients with cardiovascular events were significantly less [ 13 ( 9.8 % ) vs. 28 ( 18.9 % ) , hazard ratio : 0.37 ( 0.19–0.71 ) , P = 0.003 ] among those regressing to normoalbuminuria than those without regression . Difference was independent of treatment allocation and was significant also after adjusting for baseline characteristics [ 0.40 ( 0.20–0.79 ) , P = 0.009 ] , follow-up SBP [ 0.40 ( 0.20–0.80 ) , P = 0.010 ] or DBP [ 0.36 ( 0.18–0.73 ) , P = 0.004 ] BP or HbA1C [ 0.43 ( 0.21–0.88 ) , P = 0.021 ] . Conclusion In hypertensive type 2 diabetes patients with microalbuminuria , verapamil added-on tr and olapril did not improve renal or cardiovascular outcomes . Independent of verapamil , tr and olapril normalized albuminuria in half of patients and this translated into significant cardioprotection ",
"BACKGROUND Although several important studies have been performed in hypertensive type 2 diabetic patients , it is not known whether lowering blood pressure in normotensive ( BP offers any beneficial results on vascular complications . The current study evaluated the effect of intensive versus moderate diastolic blood pressure ( DBP ) control on diabetic vascular complications in 480 normotensive type 2 diabetic patients . METHODS The current study was a prospect i ve , r and omized controlled trial in normotensive type 2 diabetic subjects . The subjects were r and omized to intensive ( 10 mm Hg below the baseline DBP ) versus moderate ( 80 to 89 mm Hg ) DBP control . Patients in the moderate therapy group were given placebo , while the patients r and omized to intensive therapy received either nisoldipine or enalapril in a blinded manner as the initial antihypertensive medication . The primary end point evaluated was the change in creatinine clearance with the secondary endpoints consisting of change in urinary albumin excretion , progression of retinopathy and neuropathy and the incidence of cardiovascular disease . RESULTS The mean follow-up was 5.3 years . Mean BP in the intensive group was 128 + /- 0.8/75 + /- 0.3 mm Hg versus 137 + /- 0.7/81 + /- 0.3 mm Hg in the moderate group , P creatinine clearance ( P = 0.43 ) , a lower percentage of patients in the intensive group progressed from normoalbuminuria to microalbuminuria ( P = 0.012 ) and microalbuminuria to overt albuminuria ( P = 0.028 ) . The intensive BP control group also demonstrated less progression of diabetic retinopathy ( P = 0.019 ) and a lower incidence of strokes ( P = 0.03 ) . The results were the same whether enalapril or nisoldipine was used as the initial antihypertensive agent . CONCLUSION Over a five-year follow-up period , intensive ( approximately 128/75 mm Hg ) BP control in normotensive type 2 diabetic patients : ( 1 ) slowed the progression to incipient and overt diabetic nephropathy ; ( 2 ) decreased the progression of diabetic retinopathy ; and ( 3 ) diminished the incidence of stroke",
"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",
"BACKGROUND The level to which systolic blood pressure should be controlled in hypertensive patients without diabetes remains unknown . We tested the hypothesis that tight control compared with usual control of systolic blood pressure would be beneficial in such patients . METHODS In this r and omised open-label trial undertaken in 44 centres in Italy , 1111 non-diabetic patients with systolic blood pressure 150 mm Hg or greater were r and omly assigned to a target systolic blood pressure of less than 140 mm Hg ( usual control ; n=553 ) or less than 130 mm Hg ( tight control ; n=558 ) . After stratification by centre , we used a computerised r and om function to allocate patients to either group . Observers who were unaware of r and omisation read electrocardiograms and adjudicated events . Open-label agents were used to reach the r and omised targets . The primary endpoint was the rate of electrocardiographic left ventricular hypertrophy 2 years after r and omisation . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00421863 . RESULTS Over a median follow-up of 2.0 years ( IQR 1.93 - 2.03 ) , systolic and diastolic blood pressure were reduced by a mean of 23.5/8.9 mm Hg ( SD 10.6/7.0 ) in the usual-control group and by 27.3/10.4 mm Hg ( 11.0/7.5 ) in the tight-control group ( between-group difference 3.8 mm Hg systolic [ 95 % CI 2.4 - 5.2 ] , p usual-control group and in 55 of 484 patients ( 11.4 % ) of the tight-control group ( odds ratio 0.63 ; 95 % CI 0.43 - 0.91 ; p=0.013 ) . A composite cardiovascular endpoint occurred in 52 ( 9.4 % ) patients in the usual-control group and in 27 ( 4.8 % ) in the tight-control group ( hazard ratio 0.50 , 95 % CI 0.31 - 0.79 ; p=0.003 ) . Side-effects were rare and did not differ significantly between the two groups . INTERPRETATION Our findings lend support to a lower blood pressure goal than is recommended at present in non-diabetic patients with hypertension . FUNDING Boehringer-Ingelheim , Sanofi-Aventis , Pfizer",
"Background Statins reduce cardiovascular events and progression of carotid intima-media thickness ( IMT ) . & bgr;-Blockers are also known to reduce cardiovascular events , but less is known about their effects on carotid IMT . Methods and Results We conducted a r and omized , double-blind , placebo-controlled , single-center trial to compare the effects of low-dose metoprolol CR/XL ( 25 mg once daily ) and fluvastatin ( 40 mg once daily ) on the progression of carotid IMT during 36 months of treatment in 793 subjects who had carotid plaque but no symptoms of carotid artery disease . Changes in mean IMT in the common carotid artery and maximal IMT in the bulb were the main outcome variables . Death and cardiovascular events were monitored . Progression of IMTmax in the carotid bulb at both 18 and 36 months was reduced by metoprolol CR/XL ( −0.058 mm/y ; 95 % CI , −0.094 to −0.023;P = 0.004 ; and −0.023 mm/y ; 95 % CI , −0.044 to −0.003;P = 0.014 , respectively ) . Incidence of cardiovascular events tended to be lower in metoprolol CR/XL – treated patients ( 5 versus 13 patients , P = 0.055 ) . Rate of IMTmean progression in the common carotid at 36 months was reduced by fluvastatin ( −0.009 mm/y ; 95 % CI , −0.015 to −0.003;P = 0.002 ) . Women in the fluvastatin group had increased frequency of transiently high liver enzymes . Conclusions This is the first r and omized trial to show that a & bgr;-blocker can reduce the rate of progression of carotid IMT in clinical ly healthy , symptom-free subjects with carotid plaque . This suggests that & bgr;-blockers may have a favorable effect on atherosclerosis development ",
"BACKGROUND There is no evidence from r and omized trials to support a strategy of lowering systolic blood pressure below 135 to 140 mm Hg in persons with type 2 diabetes mellitus . We investigated whether therapy targeting normal systolic pressure ( i.e. , participants with type 2 diabetes at high risk for cardiovascular events . METHODS A total of 4733 participants with type 2 diabetes were r and omly assigned to intensive therapy , targeting a systolic pressure of less than 120 mm Hg , or st and ard therapy , targeting a systolic pressure of less than 140 mm Hg . The primary composite outcome was nonfatal myocardial infa rct ion , nonfatal stroke , or death from cardiovascular causes . The mean follow-up was 4.7 years . RESULTS After 1 year , the mean systolic blood pressure was 119.3 mm Hg in the intensive-therapy group and 133.5 mm Hg in the st and ard-therapy group . The annual rate of the primary outcome was 1.87 % in the intensive-therapy group and 2.09 % in the st and ard-therapy group ( hazard ratio with intensive therapy , 0.88 ; 95 % confidence interval [ CI ] , 0.73 to 1.06 ; P=0.20 ) . The annual rates of death from any cause were 1.28 % and 1.19 % in the two groups , respectively ( hazard ratio , 1.07 ; 95 % CI , 0.85 to 1.35 ; P=0.55 ) . The annual rates of stroke , a prespecified secondary outcome , were 0.32 % and 0.53 % in the two groups , respectively ( hazard ratio , 0.59 ; 95 % CI , 0.39 to 0.89 ; P=0.01 ) . Serious adverse events attributed to antihypertensive treatment occurred in 77 of the 2362 participants in the intensive-therapy group ( 3.3 % ) and 30 of the 2371 participants in the st and ard-therapy group ( 1.3 % ) ( P patients with type 2 diabetes at high risk for cardiovascular events , targeting a systolic blood pressure of less than 120 mm Hg , as compared with less than 140 mm Hg , did not reduce the rate of a composite outcome of fatal and nonfatal major cardiovascular events . ( Clinical Trials.gov number , NCT00000620 .",
"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 )",
"BACKGROUND The aim of this study is to compare the long-term effect of amlodipine and fosinopril in monotherapy or in combination on urinary albumin excretion ( UAE ) in hypertensive diabetic patients . METHODS We selected 453 hypertensive patients with type 2 diabetes and microalbuminuria and r and omized them to amlodipine ( 5 to 15 mg/day ) , fosinopril ( 10 to 30 mg/day ) , or amlodipine plus fosinopril ( 5/10 to 15/30 mg/day ) for a 3-month titration period . The nonresponder patients or those complaining of side effects during the titration period were discontinued ( n = 144 ) ; the remaining 309 patients were enrolled in the trial and treated with the same therapy for 4 years . Every 6 months , blood pressure ( BP ) , heart rate ( HR ) , UAE , creatinine clearance , and glycosylated hemoglobin ( HbA1c ) were evaluated . RESULTS The combination therapy was more effective in reducing BP than either drug alone at any time of the study without affecting glucose homeostasis . All three treatments provided a significant decrease in UAE during the 48-month study period . However , this effect was more pronounced and became evident earlier with fosinopril than with amlodipine monotherapy ( after 3 v 18 months of therapy ) . In addition , the combination therapy provided a greater antialbuminuric effect than the single drugs . This could be due to the greater antihypertensive effects , although other drug-specific effects can not be excluded . The cardiovascular outcomes were similar in the amlodipine and in the fosinopril group , but they were lower in the combination group . CONCLUSIONS These results strengthen the rationale to use a calcium-antagonist/angiotensin converting enzyme inhibitor combination in the treatment of hypertensive patients with type 2 diabetes",
"The BBB study ( Swedish for Beh and la Blodtryck Bättre or Treat Blood Pressure Better ) was a multicenter trial design ed to investigate three aspects of antihypertensive treatment : i ) Is it possible to lower the diastolic blood pressure further in \" well-treated \" hypertensive patients through intensified therapy ? ii ) Can this aim be fulfilled without increasing the incidence or severity of side-effects ? iii ) If i ) and ii ) can be answered in the affirmative , will the further reduction in diastolic blood pressure be associated with a further reduction in hypertension-associated mortality and morbidity ? Altogether 2127 hypertensive men and women with an average age of 59.8 years ( 46 - 71 ) were recruited at 142 primary health care centers in Sweden . Approximately 10,000 patient-years were accumulated . All patients had treated essential hypertension and all had diastolic blood pressures in the range 90 - 100 mmHg on three consecutive visits before entering the study . The patients were r and omized to either intensified treatment aim ing at a blood pressure or = 80 mmHg diastolic ( group A ) or to unchanged therapy ( group B ) . A difference between group A and group B in diastolic blood pressure of 7 - 7.5 mmHg was achieved for > 4 years . Adverse effects were studied in detail in 100 r and omly selected patients from each group using a special question naire and a visual analogue scale . The adverse effect score fell significantly in group A but remained unchanged in group B. Regarding cardiovascular morbidity and mortality there were no significant differences between groups A and B , the total number of strokes and myocardial infa rcts being 28 in group A and 29 in group B. ( ABSTRACT TRUNCATED AT 250 WORDS",
"In the Australian Therapeutic Trial in Mild Hypertension treated patients had significantly lower cardiovascular mortality and a significantly lower incidence of cerebrovascular complications than patients given placebos . There was , however , no difference in the incidence of nonfatal myocardial infa rct ion or other new manifestations of ischaemic heart disease . Although the evidence of benefit from treatment was clear-cut , the number of cardiovascular complications in the control group was small . This was due to several factors . Patients admitted to the trial had no preceding evidence of cardiovascular complications , the blood pressure fell spontaneously to below 95 mm Hg in almost half the control group , and patients whose blood pressures rose to levels above 110 mm Hg were given treatment , but remained in the placebo group for analysis . In both treated and placebo groups , trial end-points occurred more frequently in persons whose average diastolic blood pressure during the study remained raised . Ischaemic heart disease and many cases of stroke are due to atherosclerotic arterial disease . This appears not to be favourably influenced by antihypertensive drug therapy",
"BACKGROUND Angiotensin-converting enzyme ( ACE ) inhibitors reduce major cardiovascular events , but are not tolerated by about 20 % of patients . We therefore assessed whether the angiotensin-receptor blocker telmisartan would be effective in patients intolerant to ACE inhibitors with cardiovascular disease or diabetes with end-organ damage . METHODS After a 3-week run-in period , 5926 patients , many of whom were receiving concomitant proven therapies , were r and omised to receive telmisartan 80 mg/day ( n=2954 ) or placebo ( n=2972 ) by use of a central automated r and omisation system . R and omisation was stratified by hospital . The primary outcome was the composite of cardiovascular death , myocardial infa rct ion , stroke , or hospitalisation for heart failure . Analyses were done by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00153101 . FINDINGS The median duration of follow-up was 56 ( IQR 51 - 64 ) months . All r and omised patients were included in the efficacy analyses . Mean blood pressure was lower in the telmisartan group than in the placebo group throughout the study ( weighted mean difference between groups 4.0/2.2 [ SD 19.6/12.0 ] mm Hg ) . 465 ( 15.7 % ) patients experienced the primary outcome in the telmisartan group compared with 504 ( 17.0 % ) in the placebo group ( hazard ratio 0.92 , 95 % CI 0.81 - 1.05 , p=0.216 ) . One of the secondary outcomes -a composite of cardiovascular death , myocardial infa rct ion , or stroke-occurred in 384 ( 13.0 % ) patients on telmisartan compared with 440 ( 14.8 % ) on placebo ( 0.87 , 0.76 - 1.00 , p=0.048 unadjusted ; p=0.068 after adjustment for multiplicity of comparisons and overlap with primary outcome ) . 894 ( 30.3 % ) patients receiving telmisartan were hospitalised for a cardiovascular reason , compared with 980 ( 33.0 % ) on placebo ( relative risk 0.92 , 95 % CI 0.85 - 0.99 ; p=0.025 ) . Fewer patients permanently discontinued study medication in the telmisartan group than in the placebo group ( 639 [ 21.6 % ] vs 705 [ 23.8 % ] ; p=0.055 ) ; the most common reason for permanent discontinuation was hypotensive symptoms ( 29 [ 0.98 % ] in the telmisartan group vs 16 [ 0.54 % ] in the placebo group ) . INTERPRETATION Telmisartan was well tolerated in patients unable to tolerate ACE inhibitors . Although the drug had no significant effect on the primary outcome of this study , which included hospitalisations for heart failure , it modestly reduced the risk of the composite outcome of cardiovascular death , myocardial infa rct ion , or stroke . FUNDING Boehringer Ingelheim",
"Hypertension is the most common condition seen in primary care and leads to myocardial infa rct ion , stroke , renal failure , and death if not detected early and treated appropriately . Patients want to be assured that blood pressure ( BP ) treatment will reduce their disease burden , while clinicians want guidance on hypertension management using the best scientific evidence . This report takes a rigorous , evidence -based approach to recommend treatment thresholds , goals , and medications in the management of hypertension in adults . Evidence was drawn from r and omized controlled trials , which represent the gold st and ard for determining efficacy and effectiveness . Evidence quality and recommendations were grade d based on their effect on important outcomes . There is strong evidence to support treating hypertensive persons aged 60 years or older to a BP goal of less than 150/90 mm Hg and hypertensive persons 30 through 59 years of age to a diastolic goal of less than 90 mm Hg ; however , there is insufficient evidence in hypertensive persons younger than 60 years for a systolic goal , or in those younger than 30 years for a diastolic goal , so the panel recommends a BP of less than 140/90 mm Hg for those groups based on expert opinion . The same thresholds and goals are recommended for hypertensive adults with diabetes or nondiabetic chronic kidney disease ( CKD ) as for the general hypertensive population younger than 60 years . There is moderate evidence to support initiating drug treatment with an angiotensin-converting enzyme inhibitor , angiotensin receptor blocker , calcium channel blocker , or thiazide-type diuretic in the nonblack hypertensive population , including those with diabetes . In the black hypertensive population , including those with diabetes , a calcium channel blocker or thiazide-type diuretic is recommended as initial therapy . There is moderate evidence to support initial or add-on antihypertensive therapy with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker in persons with CKD to improve kidney outcomes . Although this guideline provides evidence -based recommendations for the management of high BP and should meet the clinical needs of most patients , these recommendations are not a substitute for clinical judgment , and decisions about care must carefully consider and incorporate the clinical characteristics and circumstances of each individual patient",
"BACKGROUND Combination therapy with angiotensin-converting-enzyme ( ACE ) inhibitors and angiotensin-receptor blockers ( ARBs ) decreases proteinuria ; however , its safety and effect on the progression of kidney disease are uncertain . Methods We provided losartan ( at a dose of 100 mg per day ) to patients with type 2 diabetes , a urinary albumin-to-creatinine ratio ( with albumin measured in milligrams and creatinine measured in grams ) of at least 300 , and an estimated glomerular filtration rate ( GFR ) of 30.0 to 89.9 ml per minute per 1.73 m(2 ) of body-surface area and then r and omly assigned them to receive lisinopril ( at a dose of 10 to 40 mg per day ) or placebo . The primary end point was the first occurrence of a change in the estimated GFR ( a decline of ≥ 30 ml per minute per 1.73 m(2 ) if the initial estimated GFR was ≥ 60 ml per minute per 1.73 m(2 ) or a decline of ≥ 50 % if the initial estimated GFR was end-stage renal disease ( ESRD ) , or death . The secondary renal end point was the first occurrence of a decline in the estimated GFR or ESRD . Safety outcomes included mortality , hyperkalemia , and acute kidney injury . Results The study was stopped early owing to safety concerns . Among 1448 r and omly assigned patients with a median follow-up of 2.2 years , there were 152 primary end-point events in the monotherapy group and 132 in the combination-therapy group ( hazard ratio with combination therapy , 0.88 ; 95 % confidence interval [ CI ] , 0.70 to 1.12 ; P=0.30 ) . A trend toward a benefit from combination therapy with respect to the secondary end point ( hazard ratio , 0.78 ; 95 % CI , 0.58 to 1.05 ; P=0.10 ) decreased with time ( P=0.02 for nonproportionality ) . There was no benefit with respect to mortality ( hazard ratio for death , 1.04 ; 95 % CI , 0.73 to 1.49 ; P=0.75 ) or cardiovascular events . Combination therapy increased the risk of hyperkalemia ( 6.3 events per 100 person-years , vs. 2.6 events per 100 person-years with monotherapy ; P ) and acute kidney injury ( 12.2 vs. 6.7 events per 100 person-years , P ACE inhibitor and an ARB was associated with an increased risk of adverse events among patients with diabetic nephropathy . ( Funded by the Cooperative Studies Program of the Department of Veterans Affairs Office of Research and Development ; VA NEPHRON-D Clinical Trials.gov number , NCT00555217 . )",
"BACKGROUND Antihypertensive therapy reduces the risk of cardiovascular events among high-risk persons and among those with a systolic blood pressure of 160 mm Hg or higher , but its role in persons at intermediate risk and with lower blood pressure is unclear . METHODS In one comparison from a 2-by-2 factorial trial , we r and omly assigned 12,705 participants at intermediate risk who did not have cardiovascular disease to receive either c and esartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day or placebo . The first co primary outcome was the composite of death from cardiovascular causes , nonfatal myocardial infa rct ion , or nonfatal stroke ; the second co primary outcome additionally included resuscitated cardiac arrest , heart failure , and revascularization . The median follow-up was 5.6 years . RESULTS The mean blood pressure of the participants at baseline was 138.1/81.9 mm Hg ; the decrease in blood pressure was 6.0/3.0 mm Hg greater in the active-treatment group than in the placebo group . The first co primary outcome occurred in 260 participants ( 4.1 % ) in the active-treatment group and in 279 ( 4.4 % ) in the placebo group ( hazard ratio , 0.93 ; 95 % confidence interval [ CI ] , 0.79 to 1.10 ; P=0.40 ) ; the second co primary outcome occurred in 312 participants ( 4.9 % ) and 328 participants ( 5.2 % ) , respectively ( hazard ratio , 0.95 ; 95 % CI , 0.81 to 1.11 ; P=0.51 ) . In one of the three prespecified hypothesis-based subgroups , participants in the subgroup for the upper third of systolic blood pressure ( > 143.5 mm Hg ) who were in the active-treatment group had significantly lower rates of the first and second co primary outcomes than those in the placebo group ; effects were neutral in the middle and lower thirds ( P=0.02 and P=0.009 , respectively , for trend in the two outcomes ) . CONCLUSIONS Therapy with c and esartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day was not associated with a lower rate of major cardiovascular events than placebo among persons at intermediate risk who did not have cardiovascular disease . ( Funded by the Canadian Institutes of Health Research and AstraZeneca ; Clinical Trials.gov number , NCT00468923 . )"
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The association of atrial fibrillation ( AF ) with an increased risk of stroke and heart failure makes it a serious health condition . Many people have AF and do not know it , and its prevalence continues to rise in parallel with the growing numbers of people living with obesity and cardiac risk factors.1,2 These elements , along with the proliferation of devices capable of monitoring the heart rhythm , have led many physicians to promote screening for AF.3 The hypothesis is that early detection would allow treatment with anticoagulation , which would then deliver a net clinical benefit . Screening , however , is not a sure win . Two pioneers of public health , Drs Wilson and Jungner , wrote a half-century ago : “ in theory ... screening is an admirable method of combating disease, ... but in practice , there are snags.”4(p7 ) A systematic review for the US Preventive Services Task Force ( USPSTF ) published in the current issue of JAMA,5 conducted in support of the USPSTF Recommendation Statement published in the same issue,6 found the current evidence insufficient to assess the balance of benefits and harms of screening for AF with electrocardiography ( ECG ) ( I statement ) . We concur with this conclusion and exp and on many of the “ snags ” of AF screening
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"Prospect i ve cohort studies involving older adults report an association of obesity and new-onset atrial fibrillation and atrial flutter . To assess this relation , we performed a longitudinal cohort study from January 1 , 2006 to December 31 , 2013 , using a national cl aims data base that tracks all inpatient , outpatient , and pharmacy cl aims data . The primary end point of new-onset atrial fibrillation was compared between obese and nonobese cohorts . We used logistic regression to determine the strength of association between obesity and new-onset atrial fibrillation controlling for age , gender , hypertension , and diabetes . Overall , 67,278 subjects were included in the cohort , divided evenly between those with and without a diagnosis of obesity . Obese subjects were significantly more likely to have hypertension ( 29.5 % vs 14.6 % ) and diabetes ( 12.7 % vs 5.2 % ) at study onset . Over 8 years of follow-up , we recorded a new diagnosis of atrial fibrillation in 1,511 ( 2.2 % ) subjects . Obesity was strongly associated with a new diagnosis of atrial fibrillation after controlling for age , gender , hypertension , and diabetes ( odds ratio 1.4 , 95 % confidence interval 1.3 to 1.6 ) . In conclusion , this information contributes to the growing evidence supporting the causal relation between obesity and atrial fibrillation , and emphasizes the need of addressing obesity as part of our therapeutic strategy to prevent atrial fibrillation",
"Background : Up-to- date epidemiological stroke studies are important for healthcare planning and evaluating prevention strategies . This population -based study investigates temporal trends in stroke incidence and case-fatality in southern Sweden . Methods : First-ever stroke cases in the local catchment area of Skåne University Hospital in Lund , Sweden , between March , 2015 and February , 2016 , were included from several sources , including 2 prospect i ve hospital-based registers , retrospective screening of primary care visits , and autopsy registers . Stroke incidence and 28-day case-fatality rates were compared with data from this area obtained through similar methodology between March , 2001 and February , 2002 . Results : Altogether , 456 and 413 first-ever stroke patients were identified during the earlier and later time periods respectively . The age- and sex-st and ardized stroke incidence rates decreased from 246 ( 95 % CI 224–270 ) to 165 ( 95 % CI 149–182 ) per 100,000 people . However , incidence remained unaltered among those Early case-fatality decreased from 14 to 11 % ( p = 0.165 ) . Conclusion : First-ever stroke incidence in southern Sweden has decreased with 33 % since the beginning of this millennium . Incidence rates have decreased among the elderly but remain unchanged among younger age groups . Our findings warrant further studies on trends in risk factor profiles and effects of prevention strategies , and heightened focus on stroke in the young",
"Objective To assess the accuracy of general practitioners , practice nurses , and interpretative software in the use of different types of electrocardiogram to diagnose atrial fibrillation . Design Prospect i ve comparison with reference st and ard of assessment of electrocardiograms by two independent specialists . Setting 49 general practice s in central Engl and . Participants 2595 patients aged 65 or over screened for atrial fibrillation as part of the screening for atrial fibrillation in the elderly ( SAFE ) study ; 49 general practitioners and 49 practice nurses . Interventions All electrocardiograms were read with the Biolog interpretative software , and a r and om sample of 12 lead , limb lead , and single lead thoracic placement electrocardiograms were assessed by general practitioners and practice nurses independently of each other and of the Biolog assessment . Main outcome measures Sensitivity , specificity , and positive and negative predictive values . Results General practitioners detected 79 out of 99 cases of atrial fibrillation on a 12 lead electrocardiogram ( sensitivity 80 % , 95 % confidence interval 71 % to 87 % ) and misinterpreted 114 out of 1355 cases of sinus rhythm as atrial fibrillation ( specificity 92 % , 90 % to 93 % ) . Practice nurses detected a similar proportion of cases of atrial fibrillation ( sensitivity 77 % , 67 % to 85 % ) , but had a lower specificity ( 85 % , 83 % to 87 % ) . The interpretative software was significantly more accurate , with a specificity of 99 % , but missed 36 of 215 cases of atrial fibrillation ( sensitivity 83 % ) . Combining general practitioners ' interpretation with the interpretative software led to a sensitivity of 92 % and a specificity of 91 % . Use of limb lead or single lead thoracic placement electrocardiograms result ed in some loss of specificity . Conclusions Many primary care professionals can not accurately detect atrial fibrillation on an electrocardiogram , and interpretative software is not sufficiently accurate to circumvent this problem , even when combined with interpretation by a general practitioner . Diagnosis of atrial fibrillation in the community needs to factor in the reading of electrocardiograms by appropriately trained people",
"Background — Whether the pattern of atrial fibrillation ( AF ) modifies the risk/benefit of anticoagulation is controversial . In ENGAGE AF-TIMI 48 trial ( Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation – Thrombolysis in Myocardial Infa rct ion 48 ) , the factor Xa inhibitor edoxaban was noninferior to warfarin in preventing stroke or systemic embolic events and significantly reduced bleeding and cardiovascular mortality . However , detailed analyses by AF pattern have not been reported . Methods and Results — The 21 105 patients were categorized as having paroxysmal ( Efficacy and safety outcomes were evaluated during the 2.8 years median follow-up and compared by AF pattern . The primary end point of stroke/systemic embolic event was lower in those patients with paroxysmal AF ( 1.49%/year ) , compared with persistent ( 1.83%/year ; P-adj = 0.015 ) and permanent AF ( 1.95%/year ; P-adj = 0.004 ) . Overall , all-cause mortality also was lower with paroxysmal ( 3.0%/year ) compared with persistent ( 4.4%/year ; P-adj 0.001 ) . Annualized major bleeding rates were similar across AF patterns ( 2.86 % versus 2.65 % versus 2.73 % ) . There was no effect modification by treatment assignment . Conclusions — In ENGAGE AF-TIMI 48 trial , patients with paroxysmal AF suffered fewer thromboembolic events and deaths compared with those with persistent and permanent AF . The efficacy and safety profile of edoxaban as compared with warfarin was consistent across the 3 patterns of AF . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00781391",
"Background : Oral anticoagulants decrease ischemic stroke rates in patients with atrial fibrillation ( AF ) but increase the risk of bleeding . For the average patient with AF , the threshold of annual ischemic stroke rate where the benefit of anticoagulation outweighs the bleeding risk ( net clinical benefit ) has been shown to be ≈1 % to 2 % . Guideline recommendations for oral anticoagulants in AF are based on the CHA2DS2-VASc stroke risk point scores , assuming that those scores translate to fixed stroke rates . However , the relationship between stroke point scores and annual stroke rates may vary substantially across population s. We sought to comprehensively assess the reported rates of stroke in patients with AF and the relationship of stroke rates to stroke risk point scores . Methods : A systematic review of cohort studies and r and omized controlled trials enrolled patients with nonvalvular AF not treated with oral anticoagulants . Results : Of the 3552 studies screened , we identified 34 studies eligible for analysis . Overall stroke rates in cohort studies were highly heterogeneous ( Q=5706.54 , P The mean North American stroke rate was less than one-third that of the mean European stroke rate ( P reported ischemic stroke rates reported a stroke rate > 2 % per year . At a CHA2DS2-VASc score of 2 , 27 % of cohorts reported stroke rates below 1 % per year , 40 % reported stroke rates between 1 and 2 % per year , and 33 % reported stroke rates > 2 % per year . Conclusions : Substantial variation exists across cohorts in overall stroke rates and rates corresponding to CHA2DS2-VASc point scores . These variations can affect the point score threshold for recommending oral anticoagulants in AF . The majority of cohorts did not observe stroke rates that would indicate a clear expected net clinical benefit for anticoagulating AF patients with CHA2DS2-VASc scores of 1 or 2"
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Background : Sleep disorders are commonly associated with acute and chronic use of alcohol and with abstinence . To date , there are four approved drugs to treat alcohol use disorder ( AUD ) : disulfiram , acamprosate , naltrexone , and nalmefene . These AUD therapies reduce the craving and risk of relapse into heavy drinking , but little is known about their effect on sleep . As recent evidence s indicate a crucial role of sleep disorders in AUD , cl aim ing that sleep problems may trigger alcohol abuse and relapses , it is fundamental to clarify the impact of those drugs on the sleep quality of AUD patients . This systematic review aims to answer the question : how does the pharmacotherapy for AUD affect sleep ? Methods : We search ed PubMed , Embase , CINAHL Plus , Cochrane , and Scopus using sleep- and AUD pharmacotherapy-related keywords . The articles included were appraised using the CASP checklists , and the risk of bias was assessed following the Cochrane risk-of-bias assessment tool . Finally , we pooled sleep outcomes in a meta- analysis to measure the overall effect . Results and Conclusion : We included 26 studies : only three studies focused on sleep as a main outcome , two with polysomnography ( objective measurement ) , and one with subjective self-reported sleep , while all the other studies reported sleep problems among the adverse effects ( subjective report ) . The only study available on disulfiram showed reduced REM sleep . Acamprosate showed no/little effect on self-reported sleep but improved sleep continuity and architecture measured by polysomnography . The two opioidergic drugs naltrexone and nalmefene had mainly detrimental effect on sleep , giving increased insomnia and /or somnolence compared with placebo , although not always significant . The meta- analysis confirmed significantly increased somnolence and insomnia in the naltrexone group , compared with the placebo . Overall , the currently available evidence s show more sleep problems with the opioidergic drugs ( especially naltrexone ) , while acamprosate seems to be well tolerated or even beneficial . Acamprosate might be a more suitable choice when patients with AUD report sleep problems . Due to the paucity of information available , and with the majority of results being subjective , more research on this topic is needed to further inform the clinical practice , ideally with more objective measurements such as polysomnography
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"AIMS A multi-centre , r and omized , double-blind , placebo-controlled trial was conducted to evaluate the efficacy and the safety of acamprosate over 8 weeks in Korean alcohol-dependent patients . METHODS One hundred and forty-two alcohol-dependent patients in 12 centres were r and omized to 8 weeks treatment with either acamprosate ( n = 72 ) or a placebo ( n = 70 ) in combination with out-patient psychosocial intervention . They were predominantly male ( 95.8 % ) , with a mean age of 44.3 + /- 8.3 years ; 76.1 % were married ; 59.9 % were employed ; 58.5 % had received previous alcoholism treatment ( previous mean number of admissions in alcoholism in-patient programmes 4.6 + /- 6.9 ) . At visits to the clinic ( weekly for 4 weeks , then biweekly for 4 weeks ) , a record was made of alcohol use ( Time-Line Follow-Back ) , alcohol craving using a Korean version of the Obsessive Compulsive Drinking Scale and a visual analogue scale , and adverse events . Serum aspartate aminotransferase , alanine aminotransferase , gamma-glutamyltransferase ( GGT ) , blood urea nitrogen and creatinine levels were measured on weeks 0 , 2 , 4 and 8 . RESULTS In the acamprosate group ( A ) , 71.4 % had had alcohol within the 2 days prior to starting medication , against 65.2 % of patients in the placebo group ( P ) ; ( P > 0.05 ) . One hundred and one subjects ( 71.1 % ) completed 8-weeks of treatment ( A , 73.6 % ; P , 68.6 % ; P > 0.05 ) . During the 8-week treatment period , 37 , ( A ) ( n = 72 ) and 32 % ( P ) ( n = 70 ) achieved continuous abstinence ( P > 0.05 ) , and 40 , ( A ) and 39 % ( P ) remained without relapse ( P > 0.05 ) ( defined as a day when a man consumed five or more drinks or a woman four or more drinks ) . The percentage of days abstinent during the 8-week treatment period was 81.2 , ( A ) and 78.5 % ( P ) ( P > 0.05 ) , and the percentage of days without heavy drinking 86.1 ( A ) and 84.9 % ( P ) ( P > 0.05 ) . The mean amount drunk per drinking occasion was 7.2 , ( A ) and 8.6 st and ard drinks ( P ) ( P > 0.05 ) . No statistically significant differences in changes in the serum GGT level or craving scores from baseline to the end-point of treatment were found between the two groups . Recency of drinking prior to commencing study drug predicted percentage of days abstinent in the first 2 weeks on treatment ; however , when ANOVAs were conducted using treatment outcomes as a dependent variable , medication condition as an independent variable and the period of abstinence prior to treatment as a covariate , a significant effect of medication condition was still not seen . CONCLUSIONS Acamprosate was ineffective in reducing drinking in this Korean sample . The result differs from that of most European acamprosate trials . This might be explained by our sample 's relatively severe alcohol dependence , and low social support , or the fact that many patients were still drinking near to their first medication . The variability of the psychosocial support , ethnicity ( which might also affect acamprosate pharmacokinetics ) and the Korean drinking style , which differs from that of Europeans , might have contributed to our negative result",
"This study compared the effects of nefazodone , a serotonergic antidepressant , with the opioid antagonist naltrexone , and an inactive placebo in 183 alcohol-dependent subjects receiving weekly relapse prevention psychotherapy . Following a single-blind , placebo lead-in period , subjects were r and omly assigned to receive study medication , which they took under double-blind conditions for 11 weeks . Naltrexone treatment was associated with significantly more adverse neuropsychiatric and gastrointestinal effects , poorer compliance , and a greater rate of treatment attrition . There were no reliable between-group differences in drinking behavior . These results indicate that nefazodone is not efficacious for treatment of alcohol dependence . Furthermore , the clinical utility of naltrexone seems to be limited by its adverse effects , a finding that has important implication s for efforts to develop medications to treat alcohol dependence",
"The objective of this study was to compare acamprosate with placebo in the treatment of alcohol-dependent patients during a 6-month post-detoxification treatment and a 3-month medication-free follow-up . Patients ( n = 330 ) were detoxified and r and omized to treatment with acamprosate ( 1998 mg/day ) or placebo within an out-patient programme including medical counselling , psychotherapy and self-help groups . The main outcome criterion was drinking behaviour as assessed by : abstinence/relapse ratio , cumulative abstinence duration ( CAD ) and the period of continued abstinence . Anxiety , depression and craving were also monitored . Intention to treat ( ITT ) statistical principles were followed . Twenty-five per cent of patients dropped out over the first 6 months . At the end of the treatment period , the abstinence rate was 57.9 % for acamprosate and 45.2 % for placebo ( P = 0.03 ) . The CAD was 110+/-77 days for acamprosate and 89+/-77 days for placebo ( P = 0.016 ) . Patients on acamprosate had a higher continuous abstinence rate and experienced less severe relapses . No differential effect was noted for anxiety , depression or craving . Treatment remained positive , but not significant , 3 months after termination of study medication . No significant difference in adverse events was noted between treatment groups . Acamprosate treatment over 180 days was consistently more effective than placebo to maintain abstinence and to diminish relapse severity",
"RATIONALE Little is known about the effect of disulfiram on subjective and autonomic nervous system cue reactivity in the laboratory . The dissuasive psychological effect manifested as a threat would seem to prevail over the pharmacological effect . OBJECTIVES The primary objective was to determine whether there was a difference in cue reactivity responses during a threat condition compared to a neutral condition during alcohol cue exposure . METHODS In a crossover r and omized study , participants received threat and neutral messages during two cue exposure sessions . The threat condition consisted of leading the patients to believe they had ingested 500 mg of disulfiram and the neutral condition of informing them that they had ingested a placebo , while in both condition they received the same placebo . RESULTS Physiological cue reactivity was demonstrated by a decrease in diastolic blood pressure during the threat compared to the neutral condition ( p=0.04 ) . Heart rate and subjective cue reactivity measures remained unchanged . There was a negative affect ( assessed by the Positive and Negative Affect Scale ) by condition by exposure interaction . CONCLUSIONS The threat of a disulfiram-ethanol reaction appears to affect cue reactivity physiologically rather than subjectively . While the data does not show changes in subjective ratings , it is possible that there are alternative beneficial effects arising from other cognitive processes that are not captivated by self-reported craving scales , reflected by decreases in negative affect and blood pressure . From this perspective , disulfiram might be recast to be more acceptable to patients",
"AIMS To evaluate the efficacy of acamprosate in maintaining abstinence in weaned alcohol-dependent patients . DESIGN A multicentre , double-blind , r and omized control trial . Patients were individually r and omly allocated to active or placebo conditions . Abstinence was assessed during a 6-month treatment period and after a 6-month follow-up period . SETTING A community-based , outpatient alcohol rehabilitation programme . PARTICIPANTS Two hundred and forty-six alcohol-dependent patients between the ages of 18 and 65 years were recruited immediately following acute , inpatient withdrawal treatment . MEASUREMENTS The primary outcome measure was self-reported abstinence from alcohol since the previous sessions at 3 , 6 , 9 and 12 months following the start of treatment , with treatment taking place for a period of 6 months . FINDINGS A significantly higher proportion of patients in the acamprosate group were abstinent after 3 months and 6 months of treatment . The percentage of patients with continuous abstinence at the end of the treatment period was almost double for the acamprosate group than for the placebo group ( 40.7 % vs. 20.8 % , respectively ) . Acamprosate significantly increased the retention of patients in the treatment programme . Six months after drug treatment ceased , the criterion of abstinence since the previous visit was reached by significantly more patients from the acamprosate group ( 43.4 % ) than from the placebo group ( 29.8 % ) , but this difference was not statistically significant at the 3-month point after cessation of study medication . CONCLUSIONS Acamprosate may be a useful pharmacological compound for the long-term treatment of alcohol-dependence when applied in a community-based rehabilitation programme",
"CONTEXT Alcohol dependence treatment may include medications , behavioral therapies , or both . It is unknown how combining these treatments may impact their effectiveness , especially in the context of primary care and other nonspecialty setting s. OBJECTIVES To evaluate the efficacy of medication , behavioral therapies , and their combinations for treatment of alcohol dependence and to evaluate placebo effect on overall outcome . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled trial conducted January 2001-January 2004 among 1383 recently alcohol-abstinent volunteers ( median age , 44 years ) from 11 US academic sites with Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , diagnoses of primary alcohol dependence . INTERVENTIONS Eight groups of patients received medical management with 16 weeks of naltrexone ( 100 mg/d ) or acamprosate ( 3 g/d ) , both , and /or both placebos , with or without a combined behavioral intervention ( CBI ) . A ninth group received CBI only ( no pills ) . Patients were also evaluated for up to 1 year after treatment . MAIN OUTCOME MEASURES Percent days abstinent from alcohol and time to first heavy drinking day . RESULTS All groups showed substantial reduction in drinking . During treatment , patients receiving naltrexone plus medical management ( n = 302 ) , CBI plus medical management and placebos ( n = 305 ) , or both naltrexone and CBI plus medical management ( n = 309 ) had higher percent days abstinent ( 80.6 , 79.2 , and 77.1 , respectively ) than the 75.1 in those receiving placebos and medical management only ( n = 305 ) , a significant naltrexone x behavioral intervention interaction ( P = .009 ) . Naltrexone also reduced risk of a heavy drinking day ( hazard ratio , 0.72 ; 97.5 % CI , 0.53 - 0.98 ; P = .02 ) over time , most evident in those receiving medical management but not CBI . Acamprosate showed no significant effect on drinking vs placebo , either by itself or with any combination of naltrexone , CBI , or both . During treatment , those receiving CBI without pills or medical management ( n = 157 ) had lower percent days abstinent ( 66.6 ) than those receiving placebo plus medical management alone ( n = 153 ) or placebo plus medical management and CBI ( n = 156 ) ( 73.8 and 79.8 , respectively ; P Patients receiving medical management with naltrexone , CBI , or both fared better on drinking outcomes , whereas acamprosate showed no evidence of efficacy , with or without CBI . No combination produced better efficacy than naltrexone or CBI alone in the presence of medical management . Placebo pills and meeting with a health care professional had a positive effect above that of CBI during treatment . Naltrexone with medical management could be delivered in health care setting s , thus serving alcohol-dependent patients who might otherwise not receive treatment . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00006206",
"Thirty male alcoholic in patients received in a r and om double-blind design placebo ( P ) or disulfiram 250 mg . ( D ) at bedtime in order to evaluate the effects of the latter on EEG-EOG sleep patterns . Subjects ( S 's ) had no major medical illness and required no medication for 3 weeks prior to the study . There were 13 disulfiram S 's and 17 placebo S 's . The total REM time decreased significantly ( p less than 0.05 ) in the D group . Total number of REM episodes decreased and latency to stage 1 REM increased in the disulfiram group . These results are characteristic of sleep patterns induced by the administration of catecholaminergics and opposite to those induced by catecholamine inhibiting agents",
"BACKGROUND Access to specialty alcoholism treatment in rural environments is limited and new treatment approaches are needed . The objective was to evaluate the efficacy of naltrexone alone and in combination with sertraline among Alaska Natives and other Alaskans living in rural setting s. An exploratory aim examined whether the Asn40Asp polymorphism of the mu-opioid receptor gene ( OPRM1 ) predicted response to naltrexone , as had been reported in Caucasians . METHODS R and omized , controlled trial enrolling 101 Alaskans with alcohol dependence , including 68 American Indians/Alaska Natives . Participants received 16 weeks of either ( 1 ) placebo ( placebo naltrexone + placebo sertraline ) , ( 2 ) naltrexone monotherapy ( 50 mg naltrexone + sertraline placebo ) and ( 3 ) naltrexone + sertraline ( 100 mg ) plus nine sessions of medical management and supportive advice . Primary outcomes included Time to First Heavy Drinking Day and Total Abstinence . RESULTS Naltrexone monotherapy demonstrated significantly higher total abstinence ( 35 % ) compared with placebo ( 12 % , p = 0027 ) and longer , but not statistically different , Time to First Heavy Drinking Day ( p = 0.093 ) . On secondary measures , naltrexone compared with placebo demonstrated significant improvements in percent days abstinent ( p = 0.024 ) and drinking-related consequences ( p = 0.02 ) . Combined sertraline and naltrexone did not differ from naltrexone alone . The pattern of findings was generally similar for the American Indian/Alaska Native sub sample . Naltrexone treatment response was significant within the group of 75 individuals who were homozygous for OPRM1 Asn40 allele . There was a small number of Asp40 carriers , precluding statistical testing of the effect of this allele on response . CONCLUSIONS Naltrexone can be used effectively to treat alcoholism in remote and rural communities , with evidence of benefit for American Indians and Alaska Natives . New models of care incorporating pharmacotherapy could reduce important health disparities related to alcoholism",
"STUDY OBJECTIVES Pain is a leading cause of sleep disturbances in medical illness . Providing effective analgesia is considered an important intervention to reduce these sleep disturbances . Opioids remain the treatment of choice to relieve postoperative pain in hospitalized patients . However , their effects on sleep in pain patients or normal subjects remain unclear , as previous studies have been conducted mainly with former opioid addicts . The purpose of this investigation was to evaluate and describe the effects of acute clinical doses of morphine on sleep in healthy pain-free subjects . DESIGN Subjects were r and omly assigned to untreated ( baseline ) , morphine ( intravenous injections of 0.1 [ DOSAGE ERROR CORRECTED ] mg/kg ) , and placebo ( intravenous injections of 0.9 % NaCI ) conditions . SETTING Sleep laboratory . PARTICIPANTS Seven healthy pain-free , nonaddicts ( 5 women , 2 men ; mean age = 25 + /- 1.6 years ) . MEASUREMENTS AND RESULTS St and ard polysomnographic sleep and respiratory variables were measured during 3 experimental conditions . The treatment effect was analyzed with a Latin square cross-over design followed , when appropriate , by Tukey contrasts . Morphine altered sleep architecture by reducing slow-wave sleep ( non-rapid eye movement stages 3 - 4 ) and rapid eye movement sleep , and by increasing non-rapid eye movement stage 2 sleep . Results did not reveal any statistical differences for other sleep and respiratory variables . CONCLUSIONS Similar to earlier findings in animals , nondependent opiate addicts , and postoperative patients , morphine was found to reduce duration of slow-wave sleep . Unlike previous reports , however , its acute administration produced a moderate reduction in rapid eye movement sleep and did not increase correlates of arousal ( ie , awakenings , electroencephalogram arousals , wake after sleep onset ) . Future studies should correlate these findings in patients with pain and evaluate whether optimal pain relief with opioid therapy can improve sleep disturbances in pain patients",
"Most published studies of the efficacy of naltrexone for alcohol treatment have focused on daily medication for relapse prevention among abstinent alcoholics . The present study compared the effects of naltrexone with those of placebo in a sample of early problem drinkers who received study medication either daily or targeted to situations identified by the patients as being high risk for heavy drinking . Patients ( n = 153 ; 58 % male ) were r and omly assigned to receive naltrexone ( 50 mg ) or placebo on a daily or targeted basis , yielding comparable numbers of patients in each of four treatment groups . Patients were trained to use structured nightly diaries in which they recorded their alcohol consumption and medication intake . Analysis was conducted with hierarchical linear modeling . Irrespective of whether they received naltrexone or placebo , patients in the targeted condition showed a reduced likelihood of any drinking . There was a reduced likelihood of heavy drinking , both for patients who received naltrexone and for patients who were in the targeted groups ( either naltrexone or placebo ) , although these effects diminished as the number of tablets available to the targeted groups was reduced over the 8-week treatment period . Although the effect was a modest one , daily naltrexone reduced the risk of heavy drinking in this patient group . Furthermore , use of a targeted approach to medication treatment appears to be a useful strategy for reducing both drinking and heavy drinking . Efforts to replicate these findings are warranted , since they suggest that schedules of medication administration other than daily should be evaluated for treatment of problem drinking",
"Aims : The aim of the study was to investigate the efficacy and safety of as-needed use of nalmefene 18 mg versus placebo in reducing alcohol consumption in patients who did not reduce their alcohol consumption after an initial assessment , i.e. the pooled subgroup of patients with at least a high drinking risk level ( men : > 60 g/day ; women : > 40 g/day ) at both screening and r and omization from the two r and omized controlled 6-month studies ESENSE 1 ( NCT00811720 ) and ESENSE 2 ( NCT00812461 ) . Methods : Nalmefene 18 mg and placebo were taken on an as-needed basis . All the patients also received a motivational and adherence-enhancing intervention ( BRENDA ) . The co- primary outcomes were number of heavy drinking days ( HDDs ) and mean total alcohol consumption ( g/day ) in Month 6 measured using the Timeline Follow-back method . Additionally , data on clinical improvement , liver function and safety were collected throughout the study . Results : The pooled population consisted of 667 patients : placebo n = 332 ; nalmefene n = 335 . There was a superior effect of nalmefene compared with placebo in reducing the number of HDDs [ treatment difference : −3.2 days ( 95 % CI : −4.8 ; −1.6 ) ; P and total alcohol consumption [ treatment difference : −14.3 g/day ( −20.8 ; −7.8 ) ; P Improvements in clinical status and liver parameters were greater in the nalmefene group compared with the placebo group . Adverse events and adverse events leading to dropout were more common with nalmefene than placebo . Conclusion : As-needed nalmefene was efficacious in reducing alcohol consumption in patients with at least a high drinking risk level at both screening and r and omization , and the effect in this subgroup was larger than in the total population",
"The opioid antagonist , naltrexone , is reported , in single centre studies , to improve the clinical outcome of individuals with alcohol dependence participating in outpatient psychosocial programmes . This is the first multicentre controlled study to evaluate the efficacy and safety of naltrexone as adjunctive treatment for alcohol dependence or abuse . Patients who met criteria for alcohol dependence ( n = 169 ) or alcohol abuse ( n = 6 ) were r and omly assigned to receive double-blind oral naltrexone 50 mg daily ( n = 90 ) or placebo ( n = 85 ) for 12 weeks as an adjunct to psychosocial treatment . The primary efficacy variable was time to first episode of heavy drinking ; secondary efficacy assessment s included time to first drink , alcohol consumption , craving , and changes in the serum biological markers gamma-glutamyl transferase ( GGT ) , and aspartate and alanine aminotransferases . Compliance was assessed by tablet counts and , in the naltrexone-treated group , by measurement of urinary concentrations of 6-ss-naltrexol . Forty-nine ( 58 % ) patients r and omized to placebo and 53 ( 59 % ) r and omized to naltrexone did not complete the study . In intention-to-treat analyses , there was no difference between groups on measures of drinking . The median reduction from baseline of serum GGT ( P : reductions in alcohol craving ( Obsessive and Compulsive Drinking Scale : OCDS ) were greater in the naltrexone group ( P : 70 patients ( 35 placebo ; 35 naltrexone ) who met an a priori definition of compliance ( 80 % tablet consumption , attendance at all follow-up appointments ) , those allocated to naltrexone reported consuming half the amount of alcohol ( P : median reduction in serum GGT activity ( P : reduction in alcohol craving ( OCDS total score : P : Obsessive subscale score : P : naltrexone raised no safety concerns . Naltrexone is effective in treating alcohol dependence/abuse in conjunction with psychosocial therapy , in patients who comply with treatment",
"The authors examined the efficacy of naltrexone as an adjunctive treatment for alcohol dependence in older adults . Forty-four veterans over 50 years of age were enrolled in a 12-week , double-blind , placebo-controlled efficacy study of naltrexone ( the equivalent of 50 mg per day ) . There were no differences in the frequency of any self-reported adverse effects or in liver enzyme values between the placebo- and naltrexone-treated groups . There were no differences between the treatment groups in the number of subjects remaining abstinent or in the number of subjects who relapsed . However , all placebo-treated subjects relapsed after sampling alcohol , whereas only three of six naltrexone-treated subjects met relapse criteria after alcohol exposure ( P = 0.024 ) . The authors conclude that naltrexone was well tolerated and efficacious in preventing relapse in subjects who drank",
"BACKGROUND Naltrexone is approved for the treatment of alcohol dependence when used in conjunction with a psychosocial intervention . This study was undertaken to examine the impact of 3 types of psychosocial treatment combined with either naltrexone or placebo treatment on alcohol dependency over 24 weeks of treatment : ( 1 ) Cognitive-Behavioral Therapy ( CBT ) + medication clinic , ( 2 ) BRENDA ( an intervention promoting pharmacotherapy ) + medication clinic , and ( 3 ) a medication clinic model with limited therapeutic content . METHODS Two hundred and forty alcohol-dependent subjects were enrolled in a 24-week double-blind placebo-controlled study of naltrexone ( 100 mg/d ) . Subjects were also r and omly assigned to 1 of 3 psychosocial interventions . All patients were assessed for alcohol use , medication adherence , and adverse events at regularly scheduled research visits . RESULTS There was a modest main treatment effect for the psychosocial condition favoring those subjects r and omized to CBT . Intent-to-treat analyses suggested that there was no overall efficacy of naltrexone and no medication by psychosocial intervention interaction . There was a relatively low level of medication adherence ( 50 % adhered ) across conditions , and this was associated with poor outcome . CONCLUSIONS Results from this 24-week treatment study demonstrate the importance of the psychosocial component in the treatment of alcohol dependence . Moreover , results demonstrate a substantial association between medication adherence and treatment outcomes . The findings suggest that further research is needed to determine the appropriate use of pharmacotherapy in maximizing treatment response",
"BACKGROUND Clinical studies with opioid antagonists for treatment of problem drinking have mainly been conducted in specialized alcohol treatment centers , included structured psychosocial treatment , and have focused on maintaining abstinence after a period of abstinence from alcohol . METHODS This multisite , r and omized double-blind study investigated targeted nalmefene in reducing heavy drinking . Specialized alcohol treatment centers and private general practice s enrolled 403 subjects ( 328 men , 75 women ) . Subjects were instructed to take nalmefene 10 to 40 mg ( n=242 ) or placebo ( n=161 ) when they believed drinking to be imminent . After 28 weeks , 57 subjects from the nalmefene group continued into a 24-week r and omized withdrawal extension . Concomitant psychosocial intervention was minimal and no treatment goals were imposed . Alcohol consumption was recorded using the time-line follow-back method . Biochemical indicators of alcohol use were also measured . RESULTS The mean monthly number of heavy drinking days ( HDDs ) during the 12-week period before inclusion was 15.5 ( SD 6.9 ) in the nalmefene group and 16.2 ( SD 6.9 ) in the placebo group . During treatment , the mean numbers of HDDs were 8.6 to 9.3 in the nalmefene group and 10.6 to 12.0 in the placebo group ( p=0.0065 ) . The levels of serum alanine aminotransferase and gamma-glutamyl transferase decreased in the nalmefene group compared with the placebo group ( p=0.0088 and 0.0023 ) . During the r and omized withdrawal period , subjects r and omized to placebo apparently returned to heavier drinking . Subjects receiving nalmefene reported more nausea , insomnia , fatigue , dizziness , and malaise than subjects on placebo . CONCLUSIONS Nalmefene appears to be effective and safe in reducing heavy drinking , even when accompanied by minimal psychosocial support",
"BACKGROUND About 50 % of alcoholic patients relapse within 3 months of treatment . Previous studies have suggested that acamprosate may help to prevent such relapse . The aim of our study was to assess the efficacy and safety of long-term acamprosate treatment in alcohol dependence . METHODS In this multicentre , double-blind , placebo-controlled study , we recruited 455 patients , aged 18 - 65 years , with chronic or episodic alcohol dependence . Patients were r and omly allocated treatment with acamprosate ( 1998 mg daily for bodyweight > 60 kg ; 1332 mg daily for placebo for 360 days . Patients were assessed on the day treatment started and on days 30 , 90 , 180 , 270 , and 360 by interview , self-report , question naire , and laboratory screening . Patients were classified as abstinent , relapsing , or non-attending . Time to first treatment failure ( relapse or non-attendance ) was the primary outcome measure . FINDINGS Seven patients were excluded from the intention-to-treat analysis because they did not attend on the first treatment day and therefore received no medication . The acamprosate ( n = 224 ) and placebo ( n = 224 ) groups were well matched in terms of baseline demographic and alcohol-related variables . 94 acamprosate-treated and 85 placebo-treated patients completed the treatment phase : of those withdrawn , 104 ( 52 in each group ) relapsed , 69 ( 33 vs 36 , respectively ) were lost to follow-up , 63 ( 31 vs 32 ) refused to continue treatment , 16 ( 15 vs 11 ) had concurrent illness , three ( two vs one ) died , ten ( six vs four ) had adverse side-effects , one ( acamprosate treated ) received the wrong medication , and three ( placebo treated ) were non-compliant . The proportion without treatment failure was higher in the acamprosate than in the placebo group throughout the treatment period ( p acamprosate-treated and 16 ( 7.1 % ) placebo-treated patients had been continuously abstinent ( p = 0.007 ) . Mean cumulative abstinence duration was significantly greater in the acamprosate group than in the placebo group ( 138.8 [ SD 137.5 ] vs 103.8 [ 119.0 ] days ; p = 0.012 ) . 148 patients ( 79 acamprosate , 69 placebo ) completed 27 months follow-up : 27 ( 11.9 % ) acamprosate-treated and 11 ( 4.9 % ) placebo-treated patients remained continuously abstinent , and the mean cumulative abstinence duration was 230.8 days ( 259.1 ) and 183.0 days ( 235.2 ) , respectively . Apart from occasional diarrhoea , there was no difference in side-effects between groups . INTERPRETATION Acamprosate is an effective and well-tolerated pharmacological adjunct to psychosocial and behavioural treatment programmes for treatment of alcohol-dependent patients",
"In a placebo-controlled , double-blind German multicenter study ( seven sites ) the efficacy of naltrexone as an adjunctive treatment in alcoholism to maintain abstinence was assessed for 12 weeks . A total of 171 detoxified patients ( 97.7 % met the DSM-III-R criteria for alcohol dependence ) were included . Patients had been abstinent for a mean of 19.5 ± 9.4 days at study entry . Eighty-four and 87 patients were r and omized to receive naltrexone ( 50 mg/day ) and placebo , respectively . Each site was instructed to provide its usual psychosocial alcohol treatment program . The primary effectiveness measure was the time to first heavy drinking as derived from self-reports of drinking ( timeline-follow-back method ) . Secondary effectiveness measures included time to first drink , amount of alcohol consumption , intensity of craving , severity of alcoholism problems , and liver enzymes . Thirty-three ( 38 % ) placebo patients and 28 ( 33 % ) naltrexone patients discontinued the study . At endpoint , 62 % of the patients in each group did not have an episode of heavy drinking . Also , there were no significant differences between the study groups concerning secondary effectiveness measures as well as compliance and adverse clinical events — with the exception of the γ-GT , which was significantly greater reduced in the naltrexone group throughout the study . Based upon an intention-to-treat population , this study confirms the safety but not the efficacy of naltrexone in prevention of alcohol relapse . Nevertheless , the question arises whether self-reports of drinking are more reliable than γ-GT as a measure of recent alcohol consumption",
"OBJECTIVE Using prospect i ve data , the authors assessed the risk of alcohol-related problems among individuals with self-reported sleep disturbances because of worry . METHOD As part of the Epidemiologic Catchment Area program , a probability sample of Baltimore residents selected by census tracts and households completed a baseline interview in 1981 . Between 1993 and 1996 , the original Baltimore cohort was traced . Of the 2,633 survivors , a total of 73 % were reinterviewed . After excluding individuals with alcohol-related problems or a current or prior history of alcohol abuse and /or dependence at the time of the 1981 interview , the authors identified a cohort of 1,537 individuals who were at risk for problem drinking at the time of the follow-up interview , a median of 12.6 years after the baseline interview . Logistic regression was used to assess the association between sleep disturbance because of worry and the risk for incident reports of alcohol problems . RESULTS Survey respondents with sleep disturbances because of worry at the time of the baseline interview had a twofold higher risk for developing an alcohol-related problem , relative to those without these sleep disturbances ( odds ratio=2.32 , 95 % confidence interval [CI]=1.31 - 4.09 ) , with adjustment for selected demographic and clinical variables . Sleep disturbance because of worry predicted the development of alcohol problems among respondents with lifetime anxiety disorders and lifetime dysphoria ( odds ratio=3.82 , 95 % CI=1.56 - 9.38 , and odds ratio=2.71 , 95 % CI=1.25 - 5.91 , respectively ) , but not among those without a history of anxiety disorders or dysphoria . CONCLUSIONS Sleep disturbances because of worry may increase risk for alcohol-related problems . Risk is highest for those with sleep disturbance and co-occurring anxiety disorders or dysphoria",
"Summary After 4 adaptation nights , IM doses of morphine sulfate ( 7.5 , 15 , 30 mg/70 kg ) and placebo were studied in 8 male postaddicts , using a cross-over design with r and omized block analysis to demonstrate significant drug effect . Morphine decreased the number and duration of REM periods , delayed the onset of the first REM period , and possibly increased the time between REM period onsets . Thus , morphine significantly decreased REM state ( REMS ) , but did not alter the pattern of maximum REMS in late night . Morphine significantly increased waking state ( WS ) but did not alter the pattern of maximum WS in early night . Morphine significantly increased tension , and shifted maximum tension from early night to middle night . Morphine altered EEG sleep patterns ; although NREM definitions were thus less certain , morphine appeared to increase NREM light sleep ( stages 1 and 2 ) and decrease NREM deep sleep ( stages 3 and 4 ) . After an initial decrease in REMS by 30 mg/70 kg of morphine , an increase in REMS was noted in the third night of the 2 pilot study subjects . The arousal response to morphine seen in post-addicts needs further study in other population s and during the course of chronic morphine use",
"Background Clinical trials have shown that naltrexone 50mg/day reduces alcohol consumption and relapse rates in alcohol dependents . Aim To investigate the efficacy of 50mg/day dose of naltrexone in the maintenance of alcohol-dependent subjects over a 36-week treatment period . Methods Subjects were r and omised into two equal groups , consisting of 116 male alcohol-dependent patients who met the DSM-IV criteria for alcohol dependence and were seeking treatment . The participants received naltrexone or placebo at a dose of 50mg/day and were treated in an outpatient clinic , offering a weekly 0.5-hour individual counselling session . Days retained in treatment were measured . Results Forty-one participants ( 35.3 % ) completed the 36-week study . Completion rates by group were 44.8 % for the 50 mg naltrexone group and 25.9 % for the placebo group ( x2=4.56 , DF=1 , 2-sided significance = 0.033 ) . Conclusion The results support the efficacy and safety of naltrexone for outpatient treatment of alcohol-dependent individuals in Iran",
"BACKGROUND Acamprosate is a newly registered drug that appears to reduce alcohol-drinking in both animal models and clinical conditions . METHOD In order to assess the efficacy and safety of the drug in the treatment of detoxified alcoholics , we performed a 90-day double-blind trial comparing two dosages of acamprosate ( 1332 mg/day and 1998 mg/day ) . RESULTS For all efficacy parameters , acamprosate appeared to be significantly superior to placebo , with a trend towards a better effect at the higher dosage . Furthermore , acamprosate appeared to be extremely safe . CONCLUSION This study confirms that acamprosate could be an interesting adjuvant for maintaining abstinence in detoxified alcoholics",
"Animal studies suggested that acamprosate modulates neuronal hyperexcitability of acute alcohol withdrawal , acting through the glutamatergic neurotransmission . In the present study , we further investigated whether treatment with acamprosate could attenuate the post-alcohol withdrawal hyperexcitability or hyperarousal in humans using brain magnetoencephalography mapping of spontaneous fields . A double-blind , r and omised , placebo-controlled study with a parallel group design comparing 2,000 mg/day of acamprosate versus placebo was conducted in alcohol-dependent subjects meeting DSM-IV criteria for alcohol dependence . Treatments were initiated 8 days before alcohol withdrawal and prolonged during the 15 following ( abstinence ) days . The study demonstrated that during alcohol withdrawal , acamprosate decreased the arousal level as reflected by alpha slow-wave index ( ASI ) measurement . This effect was mostly evidence d in left parietotemporal regions and , to a lesser extent , in the contiguous anterior , posterior and right-sided regions . In the placebo group , on the contrary , ASI measures increased between day 2 ( acute withdrawal ) and day 14 ( prolonged withdrawal ) . The present results suggest a sustained effect of acamprosate on the hyperexcitability state due to alcohol withdrawal in alcohol-dependent patients and that acamprosate may have a protective effect when administered 8 days before alcohol withdrawal",
"This study presents the results of a multicenter investigation of the efficacy of acamprosate in the treatment of patients with chronic or episodic alcohol dependence . One hundred eighteen patients were r and omly assigned to either placebo or acamprosate , and both groups were stratified for concomitant voluntary use of disulfiram . Treatment lasted for 360 days , with an additional 360-day follow-up period . The primary efficacy parameters evaluated were : relapse rate and cumulative abstinence duration ( CAD ) . Results were analyzed according to Intention-To-Treat principles using chi2 , t , and multiple regression analyses where appropriate . After 30 days on study medication , 40 of 55 ( 73 % ) acamprosate-treated patients were abstinent , compared with 26 of 55 ( 43 % ) placebo-treated patients ( p = 0.019 ) . The treatment advantage remained throughout the study medication period and was statistically significant until day 270 ( p = 0.028 ) . Twenty-seven percent of patients on acamprosate and 53 % of patients on placebo had a first drink within the first 30 days of the study . The mean CAD was 137 days ( 40 % abstinent days ) for the patients treated with acamprosate and 75 days ( 21 % abstinent days ) for the placebo group ( p = 0.013 ) . No adverse interaction between acamprosate and disulfiram occurred , and the subgroup who received both medications had a better outcome on CAD than the those on only one or no medication . Acamprosate was well tolerated . Diarrhea was the only significant treatment-induced effect . It was concluded that acamprosate was a useful and safe pharmacotherapy in the long-term treatment of alcoholism . Concomitant administration of disulfiram improved the effectiveness of acamprosate",
"Aims : To evaluate the potential interaction of 20 mg paroxetine and 1 mg alprazolam ( early morning once-daily administration ) on polysomnographic ( PSG ) sleep and subjective sleep and awakening quality , both after a single intake and after reaching a steady-state concentration . Methods : Twenty-two ( 11 for the PSG ) healthy young volunteers of both sexes with no history of sleep disturbances ( Pittsburgh Sleep Quality Index participated in a double-blind , double-dummy , placebo-controlled , repeated-dose , 4-period , cross-over study . All volunteers received all 4 treatment sequences : paroxetine – alprazolam placebo ( PAP ) ; paroxetine placebo – alprazolam ( PPA ) ; paroxetine – alprazolam ( PA ) , and paroxetine placebo – alprazolam placebo ( PLA ) , in a r and omized order . Each treatment was administered over 15 consecutive days , with a treatment-free interval of 7 days prior to the subsequent study period . In each experimental period , one PSG sleep study was performed on the 1st night ( single-dose effects ) and another study was performed on the 15th night ( repeated-dose effects ) . Additionally , two other PSG studies were assessed : an adaptation recording , and a control night recording . All-night PSG recordings were obtained following st and ard procedures . Each 30-second period was scored according to the criteria of Rechtschaffen and Kales by means of an automatic sleep analysis system : Somnolyzer 24x7TM . A self-rating scale for sleep and awakening quality and early morning behavior was completed no later than 15 min after awakening over the 15 days of each experimental intervention . General lineal models ( treatment/time ) were applied separately to each variable . Results : ( 1 ) No significant effects were observed in any sleep variables when control nights were compared with the 1st night with PLA . ( 2 ) Sleep continuity : After PAP a clear awakening effect was seen both in the first and second evaluations , mainly in wake time , movement time , number of awakenings and stage-1 duration . After PPA an evident hypnotic effect was observed on night 1 . This effect was mainly observed in maintenance variables and slightly in sleep initiation variables ; it had decreased by night 15 . After PA an intermediate behavior in the variables related to sleep continuity was seen , highlighting the absence of the tolerance phenomenon observed when PPA was administered alone . ( 3 ) Sleep architecture : The most important effects in REM sleep were observed after PAP ; an increase in REM latency and decreases in REM sleep . PAP also induced decreases in the number of non-REM and REM periods and increases in the average duration of non-REM periods and sleep cycles . PA presented a similar pattern to PAP , and PPA similar to PLA . In relation to non-REM sleep , PA showed more stage-2 and less slow-wave sleep ( SWS ) . ( 4 ) Subjective perception : No significant differences were observed between treatments while they were being taken , but impairments in subjective sleep quality , awaking quality , latency and efficiency were seen , mainly after PA but also after PPA discontinuations . Conclusion : The combination of PAP and PPA presented an intermediate pattern in relation to sleep continuity , with less awaking effect than PAP alone and less hypnotic effect than PPA alone , and without developing tolerance . The PAP and PPA combination also showed a similar effect to PAP on REM sleep and was the treatment with the longest stage 2 and shortest SWS . No subjective sleep and awakening effects were seen during drug intake but subjective withdrawal reports were seen after abrupt interruption . The high agreement rate for the epoch-by-epoch comparison between automatic and human scoring confirms the validity of the Somnolyzer 24x7 and thus facilitates sleep studies in neuropsychopharmacological research",
"BACKGROUND Nalmefene is a newer opioid antagonist that is structurally similar to naltrexone but with a number of potential pharmacological advantages for the treatment of alcohol dependence , including no dose-dependent association with toxic effects to the liver , greater oral bioavailability , longer duration of antagonist action , and more competitive binding with opioid receptor subtypes that are thought to reinforce drinking . METHODS A double-blind , placebo-controlled trial was conducted to evaluate the safety and efficacy of 2 doses of oral nalmefene for alcohol dependence . The 105 outpatient volunteers were abstinent for a mean of 2 weeks prior to r and om assignment to the placebo or 20- or 80-mg/d dose nalmefene groups for 12 weeks . Cognitive behavioral therapy was provided weekly during treatment . Self-reported drinking or abstinence was confirmed by determinations of breath alcohol concentration and by collateral informant reports . RESULTS Outcomes did not differ between the 20- and 80-mg dose nalmefene groups . Significantly fewer patients treated with nalmefene than patients given placebo relapsed to heavy drinking through 12 weeks of treatment ( P relapsing to heavy drinking was 2.4 times greater with placebo compared with nalmefene ( 95 % confidence interval , 1.05 - 5.59 ) . Patients treated with nalmefene also had fewer subsequent relapses ( P placebo . CONCLUSIONS Treatment with nalmefene was effective in preventing relapse to heavy drinking relative to placebo in alcohol-dependent out patients and was accompanied by acceptable side effects",
"AIM To compare the efficacy of topiramate with naltrexone in the treatment of alcohol dependence . DESIGN The investigation was a double-blind , placebo-controlled , 12-week study carried out at the University of São Paulo , Brazil . SAMPLE A total of 155 patients , 18 - 60 years of age , with an International Classification of Diseases ( ICD-10 ) diagnosis of alcohol dependence . METHODS After a 1-week detoxification period , patients were assigned r and omly to receive topiramate ( induction to 300 mg/day ) , naltrexone ( 50 mg/day ) or placebo . MEASUREMENTS Time to first relapse ( consumption of > 60 g ethyl alcohol ) , cumulative abstinence duration and weeks of heavy drinking . FINDINGS In intention-to-treat analyses , topiramate was statistically superior to placebo on a number of measures including time to first relapse ( 7.8 versus 5.0 weeks ) , cumulative abstinence duration ( 8.2 versus 5.6 weeks ) , weeks of heavy drinking ( 3.4 versus 5.9 ) and percentage of subjects abstinent at 4 weeks ( 67.3 versus 42.6 ) and 8 weeks ( 61.5 versus 31.5 ) , but not 12 weeks ( 46.2 versus 27.8 ) . RESULTS remained significant after controlling for Alcoholics Anonymous attendance , which was higher in topiramate than in other groups . There were no significant differences between naltrexone versus placebo or naltrexone versus topiramate groups , but naltrexone showed trends toward inferior outcomes when compared to topiramate . CONCLUSIONS The results of this study support the efficacy of topiramate in the relapse prevention of alcoholism . Suggestive evidence was also obtained for superiority of topiramate versus naltrexone , but this needs to be verified in future research with larger sample sizes",
"AIMS Sleep disturbance symptom ( SDS ) is commonly reported in alcoholic patients . Polysomnography studies suggested that acamprosate decreased SDS . We assessed this hypothesis by using data of a r and omized controlled trial . As a secondary objective , we suggested and tested the validity of a simple measurement of SDS based on the Hamilton depression and anxiety inventory subset . METHODS We re-analysed a multi-center study evaluating the efficacy of acamprosate compared with placebos on alcohol-dependent patients in concentrating on SDS change in time . The Sleep sum score index ( SAEI ) was built from check-lists on adverse effects reported at each visit and constituted our main endpoint . We also tested the validity of the short sleep index ( SSI ) defined by the four sleep items of the Hamilton depression and anxiety scales . Statistical analyses were conducted on an intention to treat basis . RESULTS A total of 592 patients were included , and 292 completed the 6-month trial . Compared with SAEI considered as our reference , the observed specificity and sensitivity of SSI were 91.6 and 87.6 % . From 40.2 % of patients experiencing SDS at baseline , this proportion decreased until 26.1 % at M6 in the placebo group and 19.5 % in the acamprosate group ( relative risk placebo/acamprosate = 1.49 , 95 % confidence interval 1.10 , 1.98 , P = 0.04 ) . CONCLUSION Treating alcoholic patients to enhance abstinence has a beneficial effect in reducing SDS , and the duration of abstinence during the treatment constitutes the main positive factor . An additional effect of acamprosate is conjectured from its effect on the glutamatergic tone . The SSI constitutes a simple , reasonably sensitive and specific instrument tool to measure SDS",
" In a one-year double-blind-treatment study with acamprosat ( six months with and six months without substance ) the efficiency of this new medicament could be proved . The number of relapses in the treatment group was significantly lower during the first 30 days with a trend to further 150 days . The substance caused very few side effects",
"OBJECTIVE The opiate antagonist drug naltrexone has been shown in a few studies with limited sample sizes to be effective when combined with psychosocial therapies for the treatment of alcohol dependence . The goal of this study was to obtain additional information regarding its efficacy in pertinent alcoholic population s and with a well-defined therapy . METHOD In this study , 131 recently abstinent alcohol-dependent out patients were treated with 12 weekly sessions of manual-guided cognitive behavioral therapy and either 50 mg/day of naltrexone ( N = 68 ) or placebo ( N = 63 ) ( with riboflavin added as a marker of compliance ) in a double-blind , r and omized clinical trial . Alcohol consumption , craving , adverse events , and urinary riboflavin levels were assessed weekly . Levels of blood markers of alcohol abuse were also ascertained during the trial . RESULTS The study completion , therapy participation , and medication compliance rates in the trial were high , with no differences between treatment groups . Naltrexone-treated subjects drank less , took longer to relapse , and had more time between relapses . They also exhibited more resistance to and control over alcohol-related thoughts and urges , as measured by a subscale of the Obsessive Compulsive Drinking Scale . Over the study period , 62 % of the naltrexone group did not relapse into heavy drinking , in comparison with 40 % of the placebo group . CONCLUSIONS Motivated individuals with moderate alcohol dependence can be treated with greater effectiveness when naltrexone is used in conjunction with weekly outpatient cognitive behavioral therapy . Naltrexone increases control over alcohol urges and improves cognitive resistance to thoughts about drinking . Thus , the therapeutic effects of cognitive behavioral therapy and naltrexone may be synergistic",
"BACKGROUND There is a large treatment gap in alcohol dependence , and current treatments are only moderately effective in preventing relapse . New treatment modalities , allowing for reduction of alcohol consumption as a treatment goal are needed . This study evaluated the efficacy of as-needed use of the opioid system modulator nalmefene in reducing alcohol consumption in patients with alcohol dependence . METHODS Six hundred and four patients ( placebo = 298 ; nalmefene = 306),≥18 years of age , with a diagnosis of alcohol dependence,≥6 heavy drinking days , and average alcohol consumption≥World Health Organization medium drinking risk level in the 4 weeks preceding screening , were r and omized ( 1:1 ) to 24 weeks of as-needed placebo or nalmefene 18 mg . RESULTS Patients taking placebo ( n = 289 ) and patients taking nalmefene ( n = 290 ) were included in the efficacy analyses . At Month 6 , there was a significant effect of nalmefene compared with placebo in reducing the number of heavy drinking days ( -2.3 days [ 95 % confidence interval:-3.8 to-.8 ] ; p = .0021 ) and total alcohol consumption ( -11.0 g/day [ 95 % confidence interval:-16.8 to-5.1 ] ; p = .0003 ) . Improvements in Clinical Global Impression and liver enzymes were larger in the nalmefene group compared with placebo at Week 24 . Adverse events ( most mild or moderate ) and dropouts due to adverse events were more common with nalmefene than placebo . The number of patients with serious adverse events was similar in the two groups . CONCLUSIONS Nalmefene provides clinical benefit , constitutes a potential new pharmacological treatment paradigm in terms of the treatment goal and dosing regimen , and provides a method to address the unmet medical need in patients with alcohol dependence that need to reduce their alcohol consumption",
"Several studies have shown the opioid antagonist naltrexone to be effective when combined with psychosocial therapies for the treatment of patients who are dependent on alcohol with fixed medication and time ( 12 weeks ) . In this study , 121 nonabstinent out patients with alcohol dependence ( DSM-IV ) were treated with sessions of cognitive coping skills ( N = 67 ) or supportive therapy ( N = 54 ) and either naltrexone 50 mg/day ( N = 63 ) or placebo ( N = 58 ) daily for the first 12 weeks and thereafter for 20 weeks only when craving alcohol ( i.e. , targeted medication ) in a prospect i ve one-center , dual , double-blind , r and omized clinical trial . The dropout rate for all subjects was 16.5 % during the first 12-week period and approximately twice that level by the end of the study . There were no significant group differences in study completion and therapy participation rates . After the continuous medication ( 12 weeks ) , the coping/naltrexone group had the best outcome , and coping/placebo had the worst . This difference remained during the targeted medication period ( the following 20 weeks ) . Naltrexone was not better than placebo in the supportive groups , but it had a significant effect in the coping groups : 27 % of the coping/naltrexone patients had no relapses to heavy drinking throughout the 32 weeks , compared with only 3 % of the coping/placebo patients . The authors ’ data confirm the original finding of the efficacy of naltrexone in conjunction with coping skills therapy . In addition , their data show that detoxification is not required and that targeted medication taken only when craving occurs is effective in maintaining the reduction in heavy drinking",
"BACKGROUND : Oral naltrexone is currently used as part of a treatment regimen for alcohol-dependent patients , but its clinical utility is hampered by poor patient adherence . A long-acting injectable naltrexone formulation ( Vivitrex ) was design ed to facilitate patient adherence by providing an extended duration of therapeutic naltrexone over 1 month , thereby eliminating the need for daily dosing . METHODS : A multicenter , r and omized , double-blind , placebo-controlled pilot study was conducted to evaluate the safety and tolerability of intramuscular repeat dose administration of this extended-release naltrexone formulation in DSM-IV alcohol-dependent patients . Thirty patients were r and omized to treatment with injectable naltrexone ( 400 mg ; n = 25 ) or a matching placebo injection ( n = 5 ) and were dosed once every 28 days over 4 months . Psychosocial treatment was offered to patients in both treatment groups . Outcome measures related to drinking activity and trough plasma concentrations of naltrexone and its primary metabolite , 6-beta-naltrexol , were evaluated . RESULTS : Injectable naltrexone was generally safe and well tolerated . Reported adverse events were mild to moderate and resolved without intervention ; only two patients discontinued due to adverse events . The most common adverse events ( nausea and headache ) occurred at a similar rate for patients in both treatment groups . Pharmacokinetic analysis confirmed that therapeutic levels of naltrexone were delivered throughout the four 1-month treatment cycles . CONCLUSIONS : The results of this pilot study provide the basis and methods for a larger , more definitive trial to determine the utility of this long-acting injectable naltrexone formulation in the treatment of alcohol-dependent patients",
"A dozen studies have been published showing that opiate antagonists suppress alcohol drinking in animals , and two independent placebo-controlled , double-blind clinical trials of naltrexone found this agent was associated with decreased alcohol craving and consumption in alcohol-dependent patients . Nalmefene is a newer opiate antagonist that has a number of potential advantages over naltrexone in the treatment of alcoholism , including no dose-dependent association with liver toxicity and more effective binding to central opiate receptors . Consequently , a double-blind pilot study was conducted to gather preliminary data on the safety and efficacy of nalmefene for reducing alcohol consumption in alcohol-dependent subjects . Twenty-one alcohol-dependent subjects meeting admission criteria were r and omly assigned to 12 weeks of double-blind treatment with 40 mg nalmefene , 10 mg nalmefene , or placebo , result ing in 7 patients /treatment group . Nalmefene was well tolerated , with no serious adverse drug reactions . The 40 mg group had a significantly lower rate of relapse ( p number of abstinent days/week ( p number of drinks/drinking day was noted for both nalmefene groups ( p placebo . These results were supported by parallel decreases in ALT . These pilot data provide preliminary support for the hypotheses that nalmefene can be safely given to alcoholics , and that nalmefene may have a role in reducing alcohol consumption and preventing relapse , particularly at the 40 mg level . A full-scale study is underway to confirm these preliminary findings",
"INTRODUCTION AND AIMS Prescribed psychotropic medications contribute to overdose mortality among people with alcohol and other drug ( AOD ) disorders . We report on prescribed psychotropic medication use among AOD treatment service attendees , focusing on sedative drugs . DESIGN AND METHODS Prospect i ve multi-site naturalistic outcome study in residential and outpatient AOD treatment facilities in Victoria and Western Australia . A convenience sample of 480 people ( 57 % male ; mean age 36.1 ) entering treatment were surveyed , of whom 313 ( 65 % ) were followed up by telephone interview after a median of 377 days . Participants ' prescribed psychotropic medication use was ascertained by self-report at baseline and follow-up . RESULTS At baseline , 41 % of participants reported prescribed sedative medication ( benzodiazepine , zopiclone or zolpidem ) use within the past month , including prescriptions to treat withdrawal symptoms . At follow-up , the cohort reported a reduced rate of past month prescribed sedative use ( 23 % ; P a sedative at follow-up ( P > 0.99 for change from baseline ) . At baseline , 40 % of participants were prescribed an antidepressant and 13 % an antipsychotic medication , which remained similar at follow-up ( 45 % and 13 % , respectively ) . DISCUSSION AND CONCLUSIONS The high level of prescribed sedative drug use reported by people receiving AOD treatment is a serious public health concern given the increasing incidence of drug overdose deaths in Australia",
"BACKGROUND There is growing evidence that pharmacological treatment with two of the best vali date d anticraving drugs , acamprosate and naltrexone , is efficacious in promoting abstinence in recently detoxified alcohol-dependent subjects . OBJECTIVE The stability of effects after termination of treatment remains to be answered , especially when combining both the drugs . METHOD After detoxification , 160 alcohol-dependent subjects participated in a r and omized , double-blind , placebo-controlled trial . Patients received naltrexone or acamprosate or a combination of naltrexone and acamprosate or placebo for 12 weeks . Patients were assessed weekly by interview , self-report , question naires and laboratory screening . Additionally , follow-up evaluation based on telephone interview of participants , general practitioners and relatives was conducted 12 weeks after terminating the medication . RESULTS At week 12 , the proportion of subjects relapsing to heavy drinking was significantly lower in the group with combined medication compared with both placebo and acamprosate ( P acamprosate and naltrexone , both of which were superior to placebo ( P Relapse rates were 28 % ( combined medication ) , 35 % ( naltrexone ) , 50 % ( acamprosate ) and 75 % ( placebo ) . After follow-up ( week 24 ) , combined medication led to relapse rates significantly lower than placebo , but not lower than acamprosate . Again , both naltrexone and acamprosate were superior to placebo . Relapse rates were 80 % ( placebo ) , 54 % ( acamprosate ) , 53 % ( naltrexone ) and 34 % ( combined medication ) . CONCLUSIONS The results of this study highlight the stability of effects of pharmacotherapy on relapse prevention in alcohol dependence",
"Adolescent alcohol use is associated with myriad adverse consequences and contributes to the leading causes of mortality among youth . Despite the magnitude of this public health problem , evidence d‐based treatment initiatives for alcohol use disorders in youth remain inadequate . Identifying promising pharmacological approaches may improve treatment options . Naltrexone is an opiate receptor antagonist that is efficacious for reducing drinking in adults by attenuating craving and the rewarding effects of alcohol . Implication s of these findings for adolescents are unclear ; however , given that r and omized trials of naltrexone with youth are non‐existent . We conducted a r and omized , double‐blinded , placebo‐controlled cross‐over study , comparing naltrexone ( 50 mg/daily ) and placebo in 22 adolescent problem drinkers aged 15–19 years ( M = 18.36 , st and ard deviation = 0.95 ; 12 women ) . The primary outcome measures were alcohol use , subjective responses to alcohol consumption , and alcohol – cue‐elicited craving assessed in the natural environment using ecological momentary assessment methods , and craving and physiological reactivity assessed using st and ard alcohol cue reactivity procedures . Results showed that naltrexone reduced the likelihood of drinking and heavy drinking ( P 's ≤ 0.03 ) , blunted craving in the laboratory and in the natural environment ( P 's ≤ 0.04 ) , and altered subjective responses to alcohol consumption ( P 's ≤ 0.01 ) . Naltrexone was generally well tolerated by participants . This study provides the first experimentally controlled evidence that naltrexone reduces drinking and craving , and alters subjective responses to alcohol in a sample of adolescent problem drinkers , and suggests larger clinical trials with long‐term follow‐ups are warranted"
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Background It is important to obtain greater insight into health-related quality of life ( HRQL ) of injury patients in order to document people 's pathways to recovery and to quantify the impact of injury on population health over time . We performed a systematic review of studies measuring HRQL in general injury population s with a generic health state measure to summarize existing knowledge . Methods Injury studies ( 1995 - 2009 ) were identified with main inclusion criteria being the use of a generic health status measure and not being restricted to one specific type of injury . Articles were collated by study design , HRQL instrument used , timing of assessment ( s ) , predictive variables and ability to detect change over time . Results Forty one studies met inclusion criteria , using 24 different generic HRQL and functional status measures ( most used were SF-36 , FIM , GOS , EQ-5D ) . The majority of the studies used a longitudinal design , but with different lengths and timings of follow-up ( mostly 6 , 12 , and 24 months ) . Different generic health measures were able to discriminate between the health status of subgroups and picked up changes in health status between discharge and 12 month follow-up . Most studies reported high prevalences of health problems within the first year after injury . The twelve studies that reported HRQL utility scores showed considerable but incomplete recovery in the first year after discharge . Conclusion This systematic review demonstrates large variation in use of HRQL instruments , study population s , and assessment time points used in studies measuring HRQL of general injury population s. This variability impedes comparison of HRQL summary scores between studies and prevented formal meta-analyses aim ing to quantify and improve precision of the impact of injury on population health over time
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"Background Globally and nationally large numbers of people are injured each year , yet there is little information on the impact of these injuries on people 's lives , on society and on health and social care services . Measurement of the burden of injuries is needed at a global , national and regional level to be able to inform injured people of the likely duration of impairment ; to guide policy makers in investing in preventative measures ; to facilitate the evaluation and cost effectiveness of interventions and to contribute to international efforts to more accurately assess the global burden of injuries . Methods / Design A prospect i ve , longitudinal multi-centre study of 1333 injured individuals , atttending Emergency Departments or admitted to hospital in four UK areas : Swansea , Surrey , Bristol and Nottingham . Specified quotas of patients with defined injuries covering the whole spectrum will be recruited . Participants ( or a proxy ) will complete a baseline question naire regarding their injury and pre-injury quality of life . Follow up occurs at 1 , 4 , and 12 months post injury or until return to normal function within 12 months , with measures of health service utilisation , impairment , disability , and health related quality of life . National estimates of the burden of injuries will be calculated by extrapolation from the sample population to national and regional computerised hospital in-patient , emergency department and mortality data . Discussion This study will provide more detailed data on the national burden of injuries than has previously been available in any country and will contribute to international collaborative efforts to more accurately assess the global burden of injuries . The results will be used to advise policy makers on prioritisation of preventive measures , support the evaluation of interventions , and provide guidance on the likely impact and degree of impairment and disability following specific injuries",
"BACKGROUND The study of both short-term and long-term outcomes after major trauma has become an increasingly important focus of injury research because of the improved survival rates attributable to the evolution of sophisticated trauma care systems . The Trauma Recovery Project ( TRP ) is a large prospect i ve epidemiologic study design ed to examine multiple outcomes after major trauma in adults aged 18 years and older , including quality of life , functional outcome , and psychologic sequelae such as depression and posttraumatic stress disorder ( PTSD ) . Patient outcomes were assessed at discharge and at 6 , 12 , and 18 months after discharge . The specific objectives of the present report are to describe functional outcomes at the discharge and 6-month follow-up time points in the TRP population and to examine the association of putative risk factors with functional outcome . METHODS Between December 1 , 1993 , and September 1 , 1996 , 1,048 eligible trauma patients triaged to four participating trauma center hospitals in the San Diego Regionalized Trauma System were enrolled in the TRP study . The admission criteria for patients were as follows : ( 1 ) age 18 years or older , ( 2 ) Glasgow Coma Scale score on admission of 12 or greater , and ( 3 ) length of stay greater than 24 hours . Functional outcome after trauma was measured before and after injury using the Quality of Well-Being ( QWB ) scale , a more sensitive index to the well end of the functioning continuum ( range , 0 = death to 1.000 = optimum functioning ) . Functional outcome was also measured using a st and ard activities of daily living ( ADL ) scale ( range , 13 = full function to 47 = maximum dysfunction ) . Follow-up at 6 months after discharge was completed for 826 patients ( 79 % ) . RESULTS The mean age was 36 + /- 14.8 years ; 70 % of the patients were male ; 52 % of the patients were white , 30 % were Hispanic , and 18 % were black or other . Less than 40 % of study participants were married or living with a partner . The mean Injury Severity Score was 13 + /- 8.5 , with 85 % blunt injuries , and a mean length of stay of 7 + /- 9.2 days . QWB scores before injury reflected the norm for a healthy adult population ( mean , 0.810 + /- 0.171 ) . After major trauma , QWB scores at discharge showed a significant degree of functional limitation ( mean , 0.401 + /- 0.045 ) . At 6-month follow-up , QWB scores continued to show high levels of functional limitation ( mean , 0.633 + /- 0.122 ) . Limitation measured using the st and ard ADL scale found only moderate dysfunction at discharge ( mean , 30.0 + /- 7.7 ) and at 6-month follow-up ( mean , 15.0 + /- 4.2 ) . Postinjury depression , PTSD , serious extremity injury , and length of stay were significant independent predictors of 6-month QWB outcome . CONCLUSION Postinjury functional limitation is a clinical ly significant complication in trauma patients at discharge and a 6-month follow-up . The QWB yields a more sensitive assessment of functional status than traditional ADL instruments . Postinjury depression , PTSD , serious extremity injury , and length of stay are significantly associated with 6-month QWB outcome",
"BACKGROUND Injury is the leading cause of preventable morbidity and functional limitation in children . Long-term sequelae are measured best by the degree of impairment after recovery from the acute traumatic event . The specific aim of this study was to determine the quality of life and functional status of moderately to severely injured pediatric trauma patients at hospital discharge and at 1 , 6 , and 12 months postinjury . METHODS We conducted a prospect i ve longitudinal study of children aged 1 to 18 years with blunt injury and Injury Severity Score > /= 9 , excluding head and spinal cord injury . Children were evaluated at hospital discharge and at 1 , 6 , and 12 months postinjury , using the Child Health Question naire ( CHQ ) , the Functional Independence Measure , and the Impact on Family Scale . Baseline and 1- and 6-month data analyses are reported . RESULTS One hundred sixty-two children were enrolled in the study , and 156 had completed 6-month data entry . The mean age was 9.3 + /- 5.3 years , and the mean Injury Severity Score was 14 + /- 7.4 . The most common cause of injury was motor vehicular-related ( 43 % ) . Fifty-eight ( 37 % ) had multisystem injuries . Femur fracture represented the most common injury ( 54.8 % ) . Families experienced economic , social , and personal strain , as measured by the Impact on Family scale . There was a significant improvement in CHQ and Functional Independence Measure scores between baseline and 1 month and between 1 month and 6 months postinjury . However , at 6 months , physical scores remained lower than age-matched norms . CONCLUSION Injury in children results in a significant burden on families . Although children demonstrate a rapid recovery of function and quality of life after blunt injury , physical function remains lower than age-matched norms at 6 months postinjury . It is unclear whether this represents a plateau in recovery or whether further improvements can be expected over longer time intervals",
"BACKGROUND The Functional Capacity Index ( FCI ) was design ed to predict physical function 12 months after injury . We report a validation study of the FCI . METHODS This was a consecutive case series registered in the Queensl and Trauma Registry who consented to the prospect i ve 12-month telephone-administered follow-up study . FCI scores measured at 12 months were compared with those originally predicted . RESULTS Complete Abbreviated Injury Scale score information was available for 617 individuals , of whom 587 ( 95 % ) could be assigned at least one FCI score ( range , 1 - 17 ) . Agreement between the largest predicted FCI and observed FCI score was poor ( kappa = 0.05 ; 95 % confidence interval , 0.00 - 0.10 ) and explained only 1 % of the variability in observed FCI . Using an encompassing model that included all FCI assignments , agreement remained poor ( kappa = 0.05 ; 95 % confidence interval , -0.02 - 0.12 ) , and the model explained only 9 % of the variability in observed FCI . CONCLUSION The predicted functional capacity poorly agrees with actual functional outcomes . Further research should consider including other ( noninjury ) explanatory factors in predicting FCI at 12 months",
"Existing national data may underreport the full burden of occupational injuries and illnesses . This study sought to provide more complete reporting and to assess disability that persisted following return to work . Workers ( n = 205 ) with a musculoskeletal injury result ing in 5 or more days of lost time or restricted duty were recruited from three employers . Data on work status and functional limitations were derived from multiple sources including administrative records , medical records , and patient interviews at baseline and 6 months . Results indicate that many workers reported continuing difficulties functioning at work following return to full duty . Measures of health-related quality of life improved over 6 months , but bodily pain and physical functioning scores remained lower than expected based on national averages . Sixteen percent of workers were reinjured within a year following initial injury . Following return to work , many workers experienced reinjury or reported persistent limitations in function 6 months following injury . Based on study findings the conclusion is drawn that OSHA logs may provide accurate measures of initial episodes of time loss from work but may underrepresent the full magnitude of lost time following work injury",
"BACKGROUND Many factors are known to impact quality of life ( QoL ) after injury , but predictors of diminished QoL and the time course of recovery remain incompletely understood . This study examines predictors and correlates of QoL measured by the Short Form-36 ( SF-36 ) one and six months postinjury . METHODS Adults with nonneurologic blunt injury were prospect ively enrolled . Demographic , injury , and socioeconomic data were collected . Patients were assessed with functional and psychologic measures . In all , 196 patients had 1-month data and 123 had 6-month data available . Scores were compared at each time point and also to population norms using t-tests . Multiple regression techniques were used to identify associations between the physical and mental component scores ( PCS & MCS ) of the SF-36 and patient characteristics . RESULTS PCS scores improved significantly ( 32.8 + /- 0.9 versus 41.3 + /- 1.0 , p MCS scores ( 47.5 + /- 1.1 versus 47.2 + /- 1.1 , p = NS ) did not . Both remained significantly below population norms . Functional Independence Measure ( FIM ) at one month was predictive of PCS at 6 months . Posttraumatic stress disorder ( PTSD ) was predictive of lower MCS , and depression was associated with poor MCS . Injury Severity Score was not associated with PCS or MCS . CONCLUSIONS Overall physical and mental QoL measured by the SF-36 remains significantly below population norms 6 months after traumatic injury . It is possible to identify patients at risk for diminished QoL early during recovery by screening for functional status , PTSD , social support , and depression . Interventions to address these areas should be further studied with respect to their impact on long-term",
"BACKGROUND The assessment of outcome after multiple injuries in a rehabilitation perspective is increasingly important in trauma research . The purpose of this study was to assess functioning and quality of life after severe injuries using a prospect i ve cohort design . METHODS One hundred and five patients with a New Injury Severity Score > 15 , aged 18 to 67 years , and admitted to a Level I trauma center were included consecutively starting January 2002 through June 2003 . Outcomes were assessed 6 weeks after discharge and 1 and 2 years after injury . Self-reported functioning and quality of life was measured by Short Form (SF)-36 , World Health Organization Disability Assessment Schedule II ( WHODAS II ) and a cognitive function scale ( COG ) . RESULTS Mean age was 35.3 years ( st and ard deviation [ SD ] , 14.0 ) , 83 % were male . Mean New Injury Severity Score was 34.6 ( SD , 12.6 ) . Disease burden measured by SF-36 showed scores below the general population . Effect sizes showed that the largest difference was for physical functioning , social functioning , and physical and emotional role functioning . The WHODAS II disability score showed substantially worse functioning compared with general population data . Profession , injury severity , pain , and physical , cognitive , and social functioning made independent contributions to WHODAS II 2 years after injury and explained 69 % of the variance of the model . CONCLUSIONS Long-lasting functional problems after multiple injuries affect most life domains . Knowledge about the reduced physical , mental , cognitive , social , and role functioning should impact the rehabilitation services provided for severely injured patients , from primary care to community rehabilitation",
"OBJECTIVE To determine the relationship between compensable status in a \" no-fault \" compensation scheme and long-term outcomes after orthopaedic trauma . DESIGN AND SETTING Prospect i ve cohort study within two adult Level 1 trauma centres in Victoria , Australia . PARTICIPANTS Blunt trauma patients aged 18 - 64 years , admitted between September 2003 and August 2004 with orthopaedic injuries and funded by the no-fault compensation scheme for transport-related injury , or deemed non-compensable . MAIN OUTCOME MEASURES 12-item Short Form Health Survey ( SF-12 ) and return to work or study at 12 months after injury . RESULTS Of 1033 eligible patients , 707 ( 68.8 % ) provided follow-up data ; 450 compensable and 247 non-compensable patients completed the study . After adjusting for differences across the groups ( age , injury severity , head injury status , injury group , and discharge destination ) using multivariate analyses , compensable patients were more likely than non-compensable patients to report moderate to severe disability at follow-up for the physical ( adjusted odds ratio [ AOR ] , 2.0 ; 95 % CI , 1.3 - 2.9 ) , and mental ( AOR , 1.6 ; 95 % CI , 1.1 - 2.5 ) summary scores of the SF-12 . Compensable patients were less likely than non-compensable patients to have returned to work or study , even after adjusting for injury severity , age , head injury status and discharge destination ( AOR , 0.6 ; 95 % CI , 0.3 - 0.9 ) . CONCLUSIONS Patients covered by the no-fault compensation system for transport-related injuries in Victoria had worse outcomes than non-compensable patients",
"BACKGROUND The importance of outcome after major injury has continued to gain attention in light of the ongoing development of sophisticated trauma care systems in the United States . The Trauma Recovery Project ( TRP ) is a large prospect i ve epidemiologic study design ed to examine multiple outcomes after major trauma in adults aged 18 years and older , including quality of life , functional outcome , and psychologic sequelae such as depression and posttraumatic stress disorder ( PTSD ) . Patient outcomes were assessed at discharge and at 6 , 12 , and 18 months after discharge . The specific objectives of the present report are to describe functional outcomes at the 12-month and 18-month follow-ups in the TRP population and to examine the association of putative risk factors with functional outcome . METHODS Between December 1 , 1993 , and September 1 , 1996 , 1,048 eligible trauma patients triaged to four participating trauma center hospitals in the San Diego Regionalized Trauma System were enrolled in the TRP study . The admission criteria for patients were as follows : ( 1 ) age 18 years or older ; ( 2 ) Glasgow Coma Scale score on admission of 12 or greater ; and ( 3 ) length of stay greater than 24 hours . Functional outcome after trauma was measured before and after injury using the Quality of Well-Being ( QWB ) Scale , an index sensitive to the well end of the functioning continuum ( 0 = death , 1.000 = optimum functioning ) . Follow-up at 12 months after discharge was completed for 806 patients ( 79 % ) , and follow-up at 18 months was completed for 780 patients ( 74 % ) . Follow-up contact at any of the study time points ( 6 , 12 , or 18 months ) was achieved for 926 ( 88 % ) patients . RESULTS The mean age was 36 + /- 14.8 years , and 70 % of the patients were male ; 52 % were white , 30 % were Hispanic , and 18 % were black or other . Less than 40 % of study participants were married or living together . The mean Injury Severity Score was 13 + /- 8.5 , with 85 % blunt injuries and a mean length of stay of 7 + /- 9.2 days . QWB scores before injury reflected the norm for a healthy adult population ( mean , 0.810 + /- 0.171 ) . At the 12-month follow-up , there were very high levels of functional limitation ( QWB mean score , 0.670 + /- 0.137 ) . Only 18 % of patients followed at 12 months had scores above 0.800 , the norm for a healthy population . There was no improvement in functional limitation at the 18-month follow-up ( QWB mean score , 0.678 + /- 0.130 ) . The majority of patients ( 80 % ) at the 18-month follow-up continued to have QWB scores below the healthy norm of 0.800 . Postinjury depression , PTSD , serious extremity injury , and intensive care unit days were significant independent predictors of 12-month and 18-month QWB outcome . CONCLUSION This study demonstrates a prolonged and profound level of functional limitation after major trauma at 12-month and 18-month follow-up . This is the first report of long-term outcome based on the QWB Scale , a st and ardized quality -of-life measure , and provides new and provocative evidence that the magnitude of dysfunction after major injury has been underestimated . Postinjury depression , PTSD , serious extremity injury , and intensive care unit days are significantly associated with 12-month and 18-month QWB outcome",
"Introduction : Studies comparing the performance of health-related quality of life instruments in osteoporosis are lacking . We compared the feasibility , validity and reliability of the osteoporosis quality of life question naire ( OQLQ ) and the QUALEFFO ( test version ) in women with vertebral deformities due to osteoporosis . Methods : Three hundred and thirty-eight patients diagnosed with primary osteoporosis and vertebral deformity and a r and om sample of 304 women from the general population ( control group ) were recruited . Patients and controls were r and omly assigned to receive either the OQLQ or the QUALEFFO , and the SF-36 and EQ-5D . Test – retest reliability was assessed in the patient group . Results : The QUALEFFO had more items with missing data and took slightly longer to administer ( 20.7 vs. 18.7 min ) . Cronbach 's α and intraclass correlation coefficient ( ICC ) values for OQLQ domains ( α : 0.75–0.91 ; ICC : 0.85–0.93 ) were slightly higher than for the QUALEFFO ( α : 0.63–0.90 ; and ICC : 0.80–0.93 ) . OQLQ and QUALEFFO domain scores correlated as expected with SF-36 and EQ-5D domains . Both question naires discriminated between patients and controls though the OQLQ showed slightly better discriminant power . Discussion : The superior performance of the OQLQ in terms of administration time , missing responses , and discriminatory capacity needs to be weighed against the advantages of using a self-administered instrument such as the QUALEFFO . A full comparison also requires data on sensitivity to change",
"PURPOSE Major trauma is the leading cause of death in children of developed countries . However , little is known about its long-term health consequences in survivors . Our aim was to describe the health condition in children at long-term after major trauma . METHODS Prospect i ve cohort study of severely injured children ( Injury Severity Score > or = 16 , age , survivors ' health condition was assessed with the following : guides to the evaluation of permanent impairment of the American Medical Association ( AMA-guides ) , Glasgow Outcome Scales ( GOS/GOSE ) , Vinel and Adaptive Behavior Scales ( VABS ) , Child Behavior Checklist ( CBCL ) , and Strengths and Difficulties Question naire ( SDQ ) . RESULTS Of 40 children , 28 were followed up . Most ( n = 16 ; 57 % ) had no impairments ( AMA guides ) ; minor to severe impairments were found in 12 of the respondents . About 80 % ( n = 22 ) had good recovery ( GOS 5 and GOSE 7/8 ) ; the remaining had moderately disability ( GOS 4 or GOSE 5/6 ) . The mean scores on the VABS and the frequency of behavioral problems on the CBCL ( 24 % ) and the SDQ ( 20 % ) were comparable to healthy peers . CONCLUSIONS This long-term follow-up study after major trauma revealed that most children had a health condition comparable to healthy peers ; about 40 % of the respondents was physically impaired or restricted in daily activities . Our experiences with different measures may be helpful to apply age-appropriate outcome measures for the clinical follow-up of children after major trauma and to design future longitudinal studies",
"PURPOSE Severe trauma is accompanied not only with functional disabilities , but also with pain , social and psychological problems of the patient . Those four aspects are important components of the construct quality of life ( QoL ) . The purpose of this study was to evaluate different question naires and to compare results between multiply injured patients and healthy controls . METHODS A group of 43 severely injured patients was matched according to age , gender , educational status and family life situation to 43 persons who had never experienced a severe injury . For the assessment of all four aspects of QoL the patients completed vali date d question naires : Beck-Depression-Inventory ( BDI ) , Short Form Health Survey ( SF-36 ) , State-Trait Anxiety Inventory ( STAI ) , a question naire for locus of control ( KKG ) , and a question naire for social support ( SOZU ) . RESULTS Patients and the control group showed remarkable differences : 22 of 43 trauma patients suffered from bad health perception ( subscale of SF-36 ) ( 8/43 control persons ) , 21 trauma patients reported moderate to severe pain ( 5/43 control persons ) , 11 of 43 trauma patients suffered from anxiety ( 4/43 control persons ) and 10 of 43 trauma patients complained about depressive symptoms ( 2/43 control persons ) . CONCLUSION One year after trauma , patients suffer from severe impairments , some even in all four aspects of QoL. The question naires used are very well applicable to patients after severe injuries . A trauma-specific Quality of Life Instrument is lacking-- and is currently developed by the german trauma registry group",
"OBJECTIVE The purpose of this study was to assess the prevalence and determinants of disabilities and return to work after severe injury in a Dutch , Level I trauma center . METHODS We prospect ively included 295 patients with an Injury Severity Score > or = 16 treated between January 1996 and January 1999 . All survivors received a mailed question naire in 2000 , at least 1 year after their initial hospital admission . Health status was measured by the EuroQol-5D instrument , and the Glasgow Outcome Scale . Additional questions were asked about cognitive functioning and return-to-work rates . Regression analyses was conducted to explore the associations between these functional outcome measures and patient characteristics . RESULTS Of the 295 patients included , 99 ( 34 % ) died in hospital or during follow-up . From the 196 survivors , a response was obtained from 166 ( 85 % ) . Of the survivors , 33 % had to change their work or daily activity as a result of their injuries . Of the 127 patients of working age ( 18 - 65 years ) , 33 ( 26 % ) were unable to work and depended on social security . Problems with mobility , self-care , daily activities , pain/discomfort , anxiety/depression , and cognitive ability were found in 34 % , 15 % , 51 % , 58 % , 37 % , and 57 % , respectively . The EuroQol-5D summary score ( 0.76 ) was far below that of the general population norms . The number of body areas affected , injury severity ( Injury Severity Score > or = 25 ) , and gender ( female ) were significant independent predictors of worse long-term functional outcome . CONCLUSION Severe trauma has a substantial impact on long-term functioning . Empiric quantitative data , as presented in this study , enable us to estimate the burden of injury and to evaluate the quality of trauma care programs",
"The traditional view of injuries as \" accidents \" , or r and om events , has result ed in the historical neglect of this area of public health . However , the most recent estimates show that injuries are among the leading causes of death and disability in the world . They affect all population s , regardless of age , sex , income , or geographic region . In 1998 , about 5.8 million people ( 97.9 per 100,000 population ) died of injuries worldwide , and injuries caused 16 % of the global burden of disease . Road traffic injuries are the 10th leading cause of death and the 9th leading cause of the burden of disease ; self-inflicted injuries , falls , and interpersonal violence follow closely . Injuries affect mostly young people , often causing long-term disability . Decreasing the burden of injuries is among the main challenges for public health in the next century -- injuries are preventable , and many effective strategies are available . Public health officials must gain a better underst and ing of the magnitude and characteristics of the problem , contribute to the development and evaluation of injury prevention programs , and develop the best possible prehospital and hospital care and rehabilitation for injured persons",
"PURPOSE To assess the prevalence of disability and h and icap among survivors of major traumatic injury ( injury severity score > 15 ) using a prospect i ve population based cohort study design . The study was set in the former Yorkshire Health Region . SUBJECTS/ METHODS A cohort of 367 individuals identified as having received and survived major traumatic injury during the 12 month period October 1988-September 1989 . OPCS disability scores and employment status at 5 years post injury were established through structured face-to-face interviews . RESULTS Three hundred and four ( 84 % response . 89 % adjusted response ) individuals were interviewed . Seventy-seven percent of these were male and they had a mean age ( SEM ) of 30.8 ( 1.06 ) years . Injuries were caused by road traffic accidents in 68 % of the cases and were primarily orthopaedic and neurological in nature . At 5 years post injury 81.2 % of individuals had some form of measurable disability principally relating to locomotion , behaviour , continence and intellectual functioning consistent with injury type . A third had an OPCS disability score of 5 or greater and approximately 1 in 12 were in the most severe categories of OPCS scores of 9 - 10 necessitating dependency on formal or informal carer assistance . Whilst five of the eight sub-scales of the SF36 showed correlation in severity proportion , general health perception and energy/vitality were higher in those with increasing disability as measured by the OPCS scale . Of those between the ages of 16 - 64 nearly half ( 49 % ) were not in paid employment at the time of follow up . CONCLUSION A high prevalence of severe permanent disability , work disability and occupation h and icap has been identified in a cohort of mainly young adult males following major traumatic injury result ing from road traffic accidents . Progress in accident prevention , injury reduction and the management of patients with serious injuries should be measured not only in terms of reduced mortality from such events but also in the long term disability and quality of life sequelea of survivors",
"OBJECTIVE Analysis of quality of life of polytraumatized critical care patients . DESIGN Prospect i ve study . MATERIAL AND METHODS Patients admitted in a 2-year period in a traumatologic intensive care unit ( ICU ) were evaluated . A quality of life question naire was completed on admission ( N = 351 ) , 1 year and 2 years after discharge from the ICU . The three question naires evaluated patients ' ability to function and communicate over the previous 2 months . A quality of life score of 0 corresponded to no limitations . Quality of life was also evaluated by the Glasgow Outcome Scale . Information was collected on the severity of illness and the diagnosis prompting ICU admission . RESULTS The mean quality of life score of survivors worsened from 0.46 + /- 0.11 points on ICU admission to 6.68 + /- 0.41 1 year after discharge , and then improved to 4.86 + /- 0.38 2 years after discharge , although the quality of life score continued to be worse than on admission ( p quality of life ( 0 points ) , after 1 year 36.5 % were normal , and after 2 years 51.6 % were normal . Three patients ( 0.9 % ) remained in vegetative state . On admission , 96.6 % were working , while after 2 years , only 57.5 % had returned to employment , although the high levels of unemployment in our country during this study may have been a particular factor in this result . All age groups except pediatric patients showed a worsened quality of life after 2 years , and patients over 60 years had worst scores on admission and after 1 and 2 years . Patients with least severity by Acute Physiology and Chronic Health Evaluation ( APACHE ) II score ( quality of life score after 1 and 2 years . Severity by Injury Severity Score showed patients with > 25 points having the greatest deterioration in quality of life . A multivariate study showed that quality of life after 2 years is influenced by age , severity of injury , and previous quality of life . CONCLUSIONS Polytraumatized patients admitted into ICU showed a worsening of their quality of life 1 and 2 years after ICU discharge , with an improvement between 1 and 2 years . Quality of life after 2 years is influenced by age , severity of illness , and previous quality of life",
"Background : Owing to the difficulty in prospect ively measuring pre-injury health status and health-related quality of life ( HRQL ) in an injured cohort , population norms or retrospective baseline scores are often used as comparators for evaluating post-injury losses . However , there has been little discussion in the literature or research into the soundness of these approaches for this purpose . Objectives : To investigate the appropriateness of the retrospectively measured baseline health status and HRQL in an injured population for the purpose of evaluating post-injury losses . Methods : A cohort of injured admitted to hospital ( n = 186 ) was followed up for 12 months after injury . Retrospectively measured pre-injury health status and HRQL scores were compared with those at 12 months after injury for participants who reported complete recovery ( n = 61 ) and those who did not . Retrospective baseline scores for the whole cohort were also compared with Australian population norms . Results : For participants who completely recovered , no significant difference was observed between scores at baseline ( measured retrospectively ) and those at 12 months after injury ( 36-item Short Form Question naire physical component summary z = −1.274 , p = 0.203 ; 36-item Short Form Question naire mental component summary z = −1.634 , p = 0.102 ; Short Form 6 Dimensions : z = −1.405 , p = 0.296 ) . A borderline significant difference was observed in HRQL as measured by the Assessment of Quality of Life ( z = −1.970 , p = 0.049 ) . Retrospectively measured pre-injury scores were consistently higher than Australian norms for all measures . Conclusions : The injured population may not be representative of the general population . Consequently , retrospective baseline measurement of pre-injury health states may be more appropriate than general population norms for the purpose of evaluating post-injury losses in this population",
"INTRODUCTION Previous scoring systems for measurement of the quality of outcome are based on scores regarding injuries to individual body regions . Known scores which describe several organ regions are of no importance for trauma patients . Therefore a new rehabilitation outcome evaluation score was developed at our hospital . METHODS Based on a prospect i ve reinvestigation , a score system was developed that allows a quantitative appraisal of the subjective and objective outcome . A complete physical examination was performed , including ROM , neurologic examination and strength analysis . Part I ( 113 questions ) is to be filled out by the patient ; part II ( 191 questions ) focusses on different body regions , physical examination and functional scoring . Included are the MFA , FIM , GCO and Frankel score . A final score ( HASPOC ) was developed to give a quantitative result of the outcome . RESULTS The new score has a range from 5 to 411 points . One hundred and fifty patients were re-examined . The mean follow-up time was 2.2 + /- 0.1 years . The SF 12 indicated an outcome more than satisfactory in 63 % of cases . The MFA demonstrated moderate or severe restrictions in 41 % , in the case of injuries of the lower extremity in 52 % of patients . The HASPOC indicated a mean of 44.5 points . CONCLUSION This paper describes the development , structure , and the quantitative outcome of rehabilitation in polytrauma patients . This st and ardized rehabilitation instrument deals with a very heterogeneous patient population and shows the rehabilitation deficits accurately . Implemented recognized evaluations allow comparison of these results with those of other scoring systems",
"OBJECTIVE The objective of this study was to evaluate the state of rehabilitation in patients with blunt multiple injuries 2 years after their initial injuries , using several st and ardized scales and a recently described comprehensive scoring system , by means of a prospect i ve clinical multicenter study . METHODS Two years after the initial injury , patients with blunt multiple injuries ( Injury Severity Score > or = 16 ) underwent a clinical follow-up in 5 German Level I trauma centers . The re assessment included a complete head-to-toe examination of the musculoskeletal system and a neurologic examination . The following patient-assessed health status scores were used to determine the quality of life : Short-Form 12 , Functional Independence Measurement , and Musculoskeletal Function Assessment . Moreover , a comprehensive scoring system developed in our department ( Hannover Score for Polytrauma Outcome [ HASPOC ] ) was used that includes provider-report ( physician 's examination ) and self-report ( score systems ) criteria . RESULTS Two hundred fifty-four of 312 patients who had been injured between January 1995 and July 1996 were reexamined between January 1 , 1997 , and July 1 , 1998 . Among the remaining 58 patients , 9 had died by the time of follow-up , and 49 patients had not accepted the invitation . The mean age of those patients who underwent reexamination was 36 + /- 13 years , the mean Injury Severity Score was 24 + /- 6 , and the mean initial Glasgow Coma Scale score was 11 + /- 4 ( Abbreviated Injury Scale ( AIS ) head score of 3.3 + /- 1.1 ; AIS face , 1.4 + /- 0.1 ; AIS chest , 3.0 + /- 0.8 ; AIS abdomen , 1.7 + /- 0.6 ; and AIS extremities , 3.4 + /- 0.8 ) . The general outcome ( Short-Form 12 ) was as follows : grade I , 9 % ; grade II , 25 % ; grade III , 29 % ; grade IV , 25 % ; grade V , 6 % ; and grade VI , 6 % . The outcome of the injured extremity demonstrated moderate or severe restrictions according to the Musculoskeletal Function Assessment in 41 % of injuries of the lower extremity and in 16 % of injuries of the upper extremity . Among patients with injuries to the lower extremity , 52 % experienced pain or impaired ability to walk related to an injury of the foot or ankle , 31 % indicated pain after a knee or thigh injury , and 27 % indicated pain after a femoral or hip injury . The most severe deficits in the range of motion occurred in the foot and the ankle region ( 13.4 % deficit of range of motion self-report correlated with the clinical examination when a scoring system was used that was described recently , the HASPOC . CONCLUSION In a st and ardized multicenter reexamination of patients with blunt multiple injuries , the general outcome was usually fair or good . Both the complaints and the objective results of specific extremity areas demonstrated that most limitations were because of injuries below the knee . These results were adequately reflected by a comprehensive scoring system , combining self-report and provider report ( HASPOC )",
"BACKGROUND Studies of the consequences of major trauma have traditionally focused on mortality rates . The aims of this study were , firstly , to investigate the long-term functional health status in a large , unselected group of severely injured patients and to compare this with normative data , and secondly , to explore relations between functional health status and personal and injury characteristics . METHODS A prospect i ve cohort study was performed at the University Medical Centre Utrecht ( a level-1 trauma centre ) in The Netherl and s. Consecutive survivors of major trauma ( ISS > or=16 ; > 16 years of age ) were included from January 1999 until December 2000 . After an average of 15 months ( range 12 - 18 months ) , 335 of the 359 eligible persons ( response rate 93 % ) participated . Demographic and injury characteristics were retrieved from a hospital-based registration system . Functional health status was measured using the 136-item Sickness impact profile ( SIP ) . Co-morbidity was assessed at the follow-up examination using a st and ard list of 26 conditions . RESULTS Subjects were 249 men and 86 women , mean age 37.7 years , mean ISS was 24.9 ( S.D.=10.6 ) . Almost , three quarters were traffic victims . Mean hospital stay was 25 days ( S.D.=23.4 ) . Discharge destination was home in 70 % of all subjects . At follow-up , the mean overall SIP score was 9.3 ( S.D.=10.1 ) , which means mild to moderate disability . The mean score on the physical function dimension was 7.2 ( S.D.=9.8 ) and that on psychosocial function was 8.7 ( S.D.=12.0 ) . Most problems were experienced in the categories of Work , Ambulation , Home Management , Recreation and Pastimes , and Alertness Behaviour . Scores of younger subjects deviated more strongly from the norm scores than those of elderly patients . Type of injury , especially lesions of traumatic brain and spinal cord and extremity injuries , was a predictor of both psychosocial and physical functioning after more than 1 year . The most important predictors , however , were age and co-morbidity",
"BACKGROUND The importance of gender differences in quality of life and psychologic morbidity after major trauma is a newly recognized focus of trauma outcomes research . The Trauma Recovery Project is a large , prospect i ve , epidemiologic study design ed to examine multiple outcomes after major trauma , including quality of life ( QoL ) , and psychologic sequelae such as depression and early symptoms of acute stress reaction ( SASR ) . The specific objectives of the present report are to examine gender differences in QoL outcomes and the early incidence of combined depression and SASR after injury , controlling for injury severity , specific body area injured , and mechanism . METHODS Between December 1 , 1993 , and September 1 , 1996 , 1,048 eligible trauma patients triaged to four participating trauma center hospitals in the San Diego Regionalized Trauma System were enrolled in the study . The enrollment criteria for the study included age 18 years and older , admission Glasgow Coma Scale score of 12 or greater , and length of stay greater than 24 hours . QoL outcome after trauma was measured after injury using the Quality of Well-being scale , a sensitive index to the well end of the functioning continuum ( range , 0 = death to 1.000 = optimum functioning ) . Depression was assessed using the Center for Epidemiologic Studies scale . SASR was assessed using the Impact of Events scale . Patient outcomes were assessed at discharge and at 6 , 12 , and 18 months after discharge . RESULTS Women ( n = 313 ) were significantly more likely to have poor QoL outcomes at follow-up than men ( n = 735 ) ( women vs. men : 12-month follow-up odds ratio [ OR ] = 2.2 , p Quality of Well-being scores at each of the 6- , 12- , and 18-month follow-up time points were markedly and significantly lower in women compared with men , independent of injury severity , serious and moderate injury status , lower extremity injury , intentional or unintentional injury type , and blunt or penetrating injury . Women were also significantly more likely to develop early combined depression and SASR at discharge ( OR = 1.7 , p depression throughout the 18-month follow-up period ( OR = 2.3 , p major trauma in men and women will be an important component of efforts to improve trauma care and long-term outcome in mature trauma systems",
"Improved survival rates of patients with multiple injuries have increased general interest in the quality of rehabilitation status after polytrauma . Due to the complex nature of multiple injuries , a special score is needed to evaluate the outcome after polytrauma . The aim of this study was to vali date the Hannover Score for Polytrauma Outcome ( HASPOC ) . One hundred seventy patients who had sustained multiple injuries were re-examined using the HASPOC 2 years after trauma . Results were correlated with the 12-Item Short Form Health Survey ( SF-12 ) , a vali date d and established scoring system . The HASPOC was also correlated with clinical parameters predictive of poor outcome . Two control groups consisting of either patients after single injuries or healthy controls were also evaluated using the HASPOC . In the group of patients after multiple injuries , the HASPOC correlated with the SF-12 in injury severity and polytrauma scores , intubation period , hospital stay , and occurrence of injuries below the knee . Differences between healthy controls , patients after single injuries , and patients after multiple injuries were statistically significant when evaluated with the HASPOC . This statistical significance was not achieved using the SF-12 . The HASPOC is a valid scoring system and useful for evaluating the rehabilitation status after polytrauma",
"Objective : To describe the preinjury health-related quality of life ( HRQL ) of orthopaedic trauma patients admitted to Level I trauma centers relative to the general population . Design : Prospect i ve cohort study using retrospectively collected preinjury HRQL measures . Setting : Two Level I adult trauma centers in Melbourne , Australia . Participants : A total of 2388 admitted orthopaedic trauma patients aged ≥18 years were included , captured by the Victorian Orthopaedic Trauma Outcomes Registry ( VOTOR ) between October 2003 and January 2006 . Patients with a significant head injury ( Abbreviated Injury Scale severity score > 2 ) , dementia , mental illness , mental disability , who were non-English speakers , or who were postoperatively confused were excluded . Main Outcome Measurements : The 12-item Short Form Health Survey ( SF-12 ) . Results : The preinjury SF-12 was obtained for 1839 patients [ median ( interquartile range ) of 6 ( 3 - 12 ) days postinjury ] . The VOTOR population reported mean physical SF-12 scores above population norms ( 50.9 vs. 48.9 , P men and confined to patients aged 18 to 54 years . The mean mental SF-12 scores of the VOTOR population were also greater than population norms ( 54.5 vs. 52.4 , P < 0.001 ) and this was most apparent for women . Conclusions : Establishing the preinjury HRQL of trauma patients is important for evaluating the quality of orthopaedic trauma patient outcomes . Reliance on population norms for this purpose may lead to an underestimation of the impact of injury in particular age and sex subgroups , but given the size of the differences seen , any underestimation would be small . Where individual preinjury data can not be collected , population norms could be used as a reasonable estimate of preinjury patient status for assessing quality of recovery"
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411801a8-06ff-11f0-808a-c43d1ab1c353
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The purpose of present study was to analyze the magnitude of the effect-size in the assessment of the cognitive status of population s over 60 years of age . The search strategy included PubMed , B-on , Ebsco , Ebsco Health , Scielo , Eric , Lilacs and Sportd iscus data bases . Only observational , cohort and cross-sectional studies were included in the meta- analysis . The central descriptors were elderly-frail , older adults , cognition and geriatric assessment and other additional terms . After applying the additional search criteria , 12 manuscripts were selected from an initial universe of 1,078 identified . When comparing the mean cognitive profile scores of the participants of the pre-frail ( n = 11,265 ) and frail ( n = 2,460 ) groups , significant statistical differences were found ( p cognitive decline is strongly associated with frailty , being a probable main clinical outcome . In this sense , any strategy aim ed at mitigating or reversing the incidence of frailty with ageing should take into account that physical and cognitive frailty seem to have similar temporal trajectories
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[
"BACKGROUND Selecting elderly persons who need geriatric interventions and making accurate treatment decisions are recurring challenges in geriatrics . Chronological age , although often used , does not seem to be the best selection criterion . Instead , the concept of frailty , which indicates several concurrent losses in re sources , can be used . METHODS The predictive values of chronological age and frailty were investigated in a large community sample of persons aged 65 years and older , r and omly drawn from the register of six municipalities in the northern regions of the Netherl and s ( 45 % of the original addressees ) . The participants ' generative capacity to sustain well-being ( i.e. , self-management abilities ) was used as the main outcome measure . RESULTS When using chronological age instead of frailty , both too many and too few persons were selected . Furthermore , frailty related more strongly ( with beta values ranging from -.25 to -.39 ) to a decline in the participants ' self-management abilities than did chronological age ( with beta values ranging from -.06 to -.14 ) . Chronological age added very little to the explained variances of all outcomes once frailty was included . CONCLUSIONS Using frailty as the criterion to select older persons at risk for interventions may be better than selecting persons based only on their chronological age",
"BACKGROUND We sought to examine whether frailty is associated with dementia , Alzheimer 's disease ( AD ) , and non-AD dementia risk . METHODS This is a prospect i ve population -based cohort derived from an integrated health maintenance organization . The sample consisted of 2,619 participants aged 65 and older without dementia at baseline followed from 1994 to 2010 . Frailty was defined as having at least 3 of the following criteria : weakness ( grip strength ) , slowness ( walking speed ) , weight loss , low physical activity , and self-reported exhaustion . Follow-up occurred every 2 years to identify incident dementia , possible or probable AD , and non-AD dementia using st and ard research criteria . Covariates came from self-report and study measures . We used adjusted Cox proportional hazards models to examine the association between frailty and each outcome . RESULTS Over a mean follow-up of 6.5 years , 521 participants developed dementia ( of which 448 developed AD ) . In the model adjusted for age , sex , education , and race , the hazard ratio for frailty was 1.78 ( 95 % confidence interval [ CI ] 1.32 - 2.40 ) . In the fully adjusted models , the hazard ratio for frailty was 1.20 for all-cause dementia ( 95 % CI 0.85 - 1.69 ) , 1.08 for AD ( 95 % CI 0.74 - 1.57 ) , and 2.57 for non-AD dementia ( 95 % CI 1.08 - 6.11 ) . For all-cause dementia , we found an interaction between baseline cognitive score and frailty ( p = .02 ) ; hazard ratio for frailty was 1.78 for those with higher global cognition ( 95 % CI 1.14 - 2.78 ) and 0.79 for those with lower global cognition ( 95 % CI 0.50 - 1.26 ) . CONCLUSION Frailty was associated with dementia when adjusting only for demographic variables but not in the fully adjusted model . Frailty was associated with higher risk of developing non-AD dementia but not AD . Although frailty was not associated with all-cause dementia in the entire sample , an association did exist in participants with higher cognitive scores . Mechanisms underlying these associations remain to be eluci date",
"Objectives : ( 1 ) Determine the relationship of geriatric assessment markers to 6-month postoperative mortality in elderly patients . ( 2 ) Create a clinical prediction rule using geriatric markers from preoperative assessment . Background : Geriatric surgery patients have unique physiologic vulnerability requiring preoperative assessment beyond the traditional evaluation of older adults . The constellation of frailty , disability and comorbidity predict poor outcomes in elderly hospitalized patients . Methods : Prospect ively , subjects ≥65 years undergoing a major operation requiring postoperative intensive care unit admission were enrolled . Preoperative geriatric assessment s included : Mini-Cog Test ( cognition ) , albumin , having fallen in the past 6-months , hematocrit , Katz Score ( function ) , and Charlson Index ( comorbidities ) . Outcome measures included 6-month mortality ( primary ) and postdischarge institutionalization ( secondary ) . Results : One hundred ten subjects ( age 74 ± 6 years ) were studied . Six-month mortality was 15 % ( 16/110 ) . Preoperative markers related to 6-month mortality included : impaired cognition ( P recent falls ( P lower albumin ( P greater anemia ( P functional dependence ( P increased comorbidities ( P functional dependence ( odds ratio 13.9 ) as the strongest predictor of 6-month mortality . Four or more markers in any one patient predicted 6-month mortality with a sensitivity of 81 % ( 13/16 ) and specificity of 86 % ( 81/94 ) . Conclusions : Geriatric assessment markers for frailty , disability and comorbidity predict 6-month postoperative mortality and postdischarge institutionalization . The preoperative presence of ≥4 geriatric-specific markers has high sensitivity and specificity for 6-month mortality . Preoperative assessment using geriatric-specific markers is a substantial paradigm shift from the traditional preoperative evaluation of older adults",
"OBJECTIVES To vali date two established frailty indexes and compare their ability to predict adverse outcomes in a diverse , elderly , community-dwelling sample of men and women . DESIGN Prospect i ve observational study . SETTING A diverse defined geographic area of Boston . PARTICIPANTS Seven hundred sixty-five community-dwelling participants in the Maintenance of Balance , Independent Living , Intellect , and Zest in the Elderly Boston Study . MEASUREMENTS Two published frailty indexes , recurrent falls , disability , overnight hospitalization , emergency department ( ED ) visits , chronic medical conditions , self-reported health , physical function , cognitive ability ( including executive function ) , and depression . One index was developed from the Study of Osteoporotic Fractures ( SOF ) and the other from the Cardiovascular Health Study ( CHS ) . RESULTS The SOF frailty index classified 77.1 % as robust , 18.7 % as prefrail , and 4.2 % as frail . The CHS frailty index classified 51.2 % as robust , 38.8 % as prefrail , and 10.0 % as frail . Both frailty indexes ( SOF ; CHS ) were similar in their ability to predict key geriatric outcomes such as recurrent falls ( hazard ratio (HR)(frail)=2.2 , 95 % confidence interval (CI)=1.2 - 4.0 ; HR(frail)=1.9 , 95 % CI=1.2 - 3.1 ) , overnight hospitalization ( odds ratio (OR)(frail)=3.5 , 95 % CI=1.5 - 8.0 ; OR(frail)=4.4 , 95 % CI=2.4 - 8.2 ) , ED visits ( OR(frail)=3.5 , 95 % CI=1.4,8.8 ; OR(frail)=3.1 , 95 % CI=1.6 - 5.9 ) , and disability ( OR(frail)=5.4 , 95 % CI=2.3 - 12.3 ; OR(frail)=7.7 , 95 % CI=4.0 - 14.7 ) , as well as chronic medical conditions , physical function , cognitive ability , and depression . CONCLUSION Two established frailty indexes were vali date d using an independent elderly sample of diverse men and women ; both indexes were good at distinguishing geriatric conditions and predicting recurrent falls , overnight hospitalization , and ED visits according to level of frailty . Although both indexes are good measures of frailty , the simpler SOF index may be easier and more practical in a clinical setting",
"Background and aims : Objectives were to develop a frailty index ( FI ) based on a st and ard comprehensive geriatric assessment ( CGA ) derived from a clinical examination ; to assess the validity of the FI-CGA and to compare its precision with other frailty measures . Methods : Design : Secondary analysis of a prospect i ve cohort study , with five-year follow-up data . Setting : Second phase of the Canadian Study of Health and Aging ( CSHA-2 ) ; clinical examinations were performed in clinics , nursing homes , and patients ’ homes . Participants : People selected ( as either cognitively impaired cases or unimpaired controls ) to receive the CSHA-2 clinical examination ( n=2305 ; women=1431 ) . Measurements : Clinical and performance-based measures and diagnostic data were extracted to correspond to the 10 impairment domains and the single comorbidity domain of a CGA . The proportion of deficits accumulated in each domain was calculated to yield the FI-CGA . The FI-CGA was vali date d and its predictive ability compared with other frailty measures . Results : Within the seven grade s of fitness/frailty identified , subjects with greater frailty were older , less educated , and more likely to be women . The FI-CGA correlated highly with a previously vali date d , empirically-derived frailty index ( r=0.76 ) . Frailty was associated with higher risk of death ( for each increment in frailty , the hazard ratio , adjusted for age , sex and education , was 1.23 ( 95 % CI 1.18–1.29 ) and institutionalization ( HR 1.20 ; 1.10–1.32 ) . Conclusions : In a population survey , the FI-CGA is a valid means of quantifying frailty from routinely collected data",
"Objectives Cognitive decline is related to frailty . Frailty can be operationalized in different ways , which have an unknown impact on the estimation of risk . Here , we compared 3 frailty measures in relation to cognitive changes and mortality in the Canadian Study of Health and Aging ( CSHA ) . Design Prospect i ve population -based study , with 5 year follow up . Participants / Setting 2,305 subjects aged 70 + years . Methods For each participant , cognitive status was measured by the errors in the Modified Mini-Mental State Examination ( 3MS ) score . Three frailty measures were used : a Frailty Index based on the Comprehensive Geriatric Assessment ( FI-CGA ) evaluated from 47 potential deficits , a Clinical Frailty Score and the Fried frailty phenotype . Multivariate Poisson regression and multivariate logistic regression were used to examine the association between baseline cognitive errors and frailty and death , respectively , while controlling for possible confounders ( age , sex , education , and baseline cognitive status ) . Results Changes in cognitive status were strongly associated with baseline cognition and frailty , however defined . In multivariate models adjusted for age , sex and education , each frailty measure was associated with cognitive decline and with mortality . The frailest people ( from the highest FI-CGA tertile ) rarely showed cognitive improvement or stabilization ( 1.5 % , 95 % CI=0.002%–2.8 % ) compared with non-frail people ( from the lowest tertile of the FI-CGA ) , of whom 27.8 % ( 95 % CI=24.5%–31.1 % ) did not deteriorate . Conclusions Frail elderly people have an increased risk of cognitive decline . All frailty measures allowed quantification of individual vulnerability and predict both cognitive changes and mortality"
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4118022a-06ff-11f0-808a-c43d1ab1c353
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Background In observational studies anaemia and iron deficiency are associated with cognitive deficits , suggesting that iron supplementation may improve cognitive function . However , due to the potential for confounding by socio-economic status in observational studies , this needs to be verified in data from r and omised controlled trials ( RCTs ) . Aim To assess whether iron supplementation improved cognitive domains : concentration , intelligence , memory , psychomotor skills and scholastic achievement . Methodology Search es included MEDLINE , EMBASE , PsychINFO , Cochrane CENTRAL and bibliographies ( to November 2008 ) . Inclusion , data extraction and validity assessment were duplicated , and the meta- analysis used the st and ardised mean difference ( SMD ) . Subgrouping , sensitivity analysis , assessment of publication bias and heterogeneity were employed . Results Fourteen RCTs of children aged 6 + , adolescents and women were included ; no RCTs in men or older people were found . Iron supplementation improved attention and concentration irrespective of baseline iron status ( SMD 0.59 , 95 % CI 0.29 to 0.90 ) without heterogeneity . In anaemic groups supplementation improved intelligence quotient ( IQ ) by 2.5 points ( 95 % CI 1.24 to 3.76 ) , but had no effect on non-anaemic participants , or on memory , psychomotor skills or scholastic achievement . However , the funnel plot suggested modest publication bias . The limited number of included studies were generally small , short and method ologically weak . Conclusions There was some evidence that iron supplementation improved attention , concentration and IQ , but this requires confirmation with well-powered , blinded , independently funded RCTs of at least one year 's duration in different age groups including children , adolescents , adults and older people , and across all levels of baseline iron status
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"Many studies have reported comparable hemoglobin response in subjects given intermittent and daily iron supplements . However , the effect of intermittent iron supplementation on impaired cognitive function , one of the serious consequences of iron deficiency among children , has not been studied . We investigated the effects of 1 d/wk ( weekly ) and 5 d/wk ( daily ) iron supplementation on changes in results of intelligence quotient ( IQ ) , Thai language , and mathematics tests among Thai primary schoolchildren . A double-blind , r and omized , placebo-controlled trial was conducted . Primary schoolchildren ( n = 397 ) were r and omly assigned to receive iron supplements daily or weekly or placebo . Ferrous sulfate ( 300 mg ) or placebo tablets were given under direct observation by the research er for 16 wk . Changes in IQ , and Thai language and mathematics scores were then compared . The increases in hemoglobin concentration were comparable in the weekly and daily iron supplementation groups but serum ferritin increased more in the children supplemented daily . Children receiving daily iron supplements , however , had a significantly lower increase in IQ ( 3 + /- 12 points ) than those receiving the supplement weekly ( 6 + /- 12 points ) or placebo ( 6 + /- 12 points ) , whereas the last-mentioned two groups did not differ . Z-scores of Thai language and mathematics test results did not differ among the groups . We conclude that weekly iron supplementation is the regimen of choice in this study community",
"The present study investigates the effect of iron supplementation on measures of school performance among 78 iron-deficient anemic and 41 nonanemic children in an economically deprived rural area in Central Java , Indonesia . All the subjects were treated for ancylostomiasis before iron supplementation . They were r and omly assigned to either an iron or placebo group . Hematological and behavioral measurements were obtained immediately before ( T1 ) and after ( T2 ) the iron and placebo treatments . Iron treatment for a 3-mo period result ed in substantive increases in mean Hgb , Hct , and transferrin saturation among the iron-deficient anemic children . Furthermore , changes in the iron status of iron-deficient anemic children were associated with significant changes in the school achievement test scores of iron-deficient anemic children . T2 evaluation of achievement test scores indicated that the difference between iron-treated anemic and nonanemic children was still statistically significant . However , when T1 scores were entered as a covariate , iron-deficient anemic subjects treated with iron obtained significantly higher delta achievement scores . Findings from the present study indicate that iron supplementation among iron-deficient anemic children benefits learning processes as measured by the school achievement test scores",
"The aim of this study was to determine whether iron deficiency anemia ( IDA ) in mothers alters their maternal cognitive and behavioral performance , the mother-infant interaction , and the infant 's development . This article focuses on the relation between IDA and cognition as well as behavioral affect in the young mothers . This prospect i ve , r and omized , controlled , intervention trial was conducted in South Africa among 3 groups of mothers : nonanemic controls and anemic mothers receiving either placebo ( 10 microg folate and 25 mg vitamin C ) or daily iron ( 125 mg FeS0(4 ) , 10 microg folate , 25 mg vitamin C ) . Mothers of full-term normal birth weight babies were followed from 10 wk to 9 mo postpartum ( n = 81 ) . Maternal hematologic and iron status , socioeconomic , cognitive , and emotional status , mother-infant interaction , and the development of the infants were assessed at 10 wk and 9 mo postpartum . Behavioral and cognitive variables at baseline did not differ between iron-deficient anemic mothers and nonanemic mothers . However , iron treatment result ed in a 25 % improvement ( P depression and stress scales as well as in the Raven 's Progressive Matrices test . Anemic mothers administered placebo did not improve in behavioral measures . Multivariate analysis showed a strong association between iron status variables ( hemoglobin , mean corpuscular volume , and transferrin saturation ) and cognitive variables ( Digit Symbol ) as well as behavioral variables ( anxiety , stress , depression ) . This study demonstrates that there is a strong relation between iron status and depression , stress , and cognitive functioning in poor African mothers during the postpartum period . There are likely ramifications of this poorer \" functioning \" on mother-child interactions and infant development , but the constraints around this relation will have to be defined in larger studies",
"The aim of this study was to determine whether iron deficiency anemia ( IDA ) in young South African mothers alters mother-infant interactions and the infant 's development . The study was a prospect i ve , r and omized , controlled intervention trial with 3 groups of mothers : nonanemic controls and anemic mothers administered either placebo ( 25 mg ascorbic acid and 10 microg folate ) or daily iron treatment ( 125 mg FeSO(4 ) plus ascorbate and folate ) . Mothers of full-term , normal birth weight infants ( n = 81 ) were followed from 10 wk to 9 mo postpartum . Maternal iron status , socioeconomic level , mother-infant interaction [ Parent/Caregiver Involvement Scale ( PCIS scale ) ] , and infant development ( Griffiths scale ) were assessed . At baseline , anemic mothers tended ( P responsive to , and more controlling of , their infants . Infants of anemic mothers were developmentally delayed at 10 wk in h and -eye movement and overall quotient . Despite normalization of maternal iron status with supplementation in some mothers , the developmental delays were not diminished at 9 mo . At 9 mo , anemic mothers were significantly more \" negative \" towards their babies , engaged less in goal setting , and were less \" responsive \" than control mothers . In contrast , the behavior of anemic mothers given iron treatment toward their children was similar to that of the control mothers on all 11 scales of the PCIS . In conclusion , IDA altered mother-child interactions at both 10 wk and 9 mo postpartum . Additionally , infants whose mothers were anemic in the early postpartum scored worse on developmental tests at 10 wk and 9 mo of age",
"BACKGROUND Evidence suggests that brain iron deficiency at any time in life may disrupt metabolic processes and subsequently change cognitive and behavioral functioning . Women of reproductive age are among those most vulnerable to iron deficiency and may be at high risk for cognitive alterations due to iron deficiency . OBJECTIVE We aim ed to examine the relation between iron status and cognitive abilities in young women . DESIGN A blinded , placebo-controlled , stratified intervention study was conducted in women aged 18 - 35 y of varied iron status who were r and omly assigned to receive iron supplements or a placebo . Cognition was assessed by using 8 cognitive performance tasks ( from Detterman 's Cognitive Abilities Test ) at baseline ( n = 149 ) and after 16 wk of treatment ( n = 113 ) . RESULTS At baseline , the iron-sufficient women ( n = 42 ) performed better on cognitive tasks ( P = 0.011 ) and completed them faster ( P = 0.038 ) than did the women with iron deficiency anemia ( n = 34 ) . Factors representing performance accuracy and the time needed to complete the tasks by the iron-deficient but nonanemic women ( n = 73 ) were intermediate between the 2 extremes of iron status . After treatment , a significant improvement in serum ferritin was associated with a 5 - 7-fold improvement in cognitive performance , whereas a significant improvement in hemoglobin was related to improved speed in completing the cognitive tasks . CONCLUSIONS Iron status is a significant factor in cognitive performance in women of reproductive age . Severity of anemia primarily affects processing speed , and severity of iron deficiency affects accuracy of cognitive function over a broad range of tasks . Thus , the effects of iron deficiency on cognition are not limited to the developing brain",
"BACKGROUND Deficiencies of iron and zinc are associated with delayed development , growth faltering , and increased infectious-disease morbidity during infancy and childhood . Combined iron and zinc supplementation may therefore be a logical preventive strategy . OBJECTIVE The objective of the study was to compare the effects of combined iron and zinc supplementation in infancy with the effects of iron and zinc as single micronutrients on growth , psychomotor development , and incidence of infectious disease . DESIGN Indonesian infants ( n = 680 ) were r and omly assigned to daily supplementation with 10 mg Fe ( Fe group ) , 10 mg Zn ( Zn group ) , 10 mg Fe and 10 mg Zn ( Fe+Zn group ) , or placebo from 6 to 12 mo of age . Anthropometric indexes , developmental indexes ( Bayley Scales of Infant Development ; BSID ) , and morbidity were recorded . RESULTS At 12 mo , two-factor analysis of variance showed a significant interaction between iron and zinc for weight-for-age z score , knee-heel length , and BSID psychomotor development . Weight-for-age z score was higher in the Zn group than in the placebo and Fe+Zn groups , knee-heel length was higher in the Zn and Fe groups than in the placebo group , and the BSID psychomotor development index was higher in the Fe group than in the placebo group . No significant effect on morbidity was found . CONCLUSIONS Single supplementation with zinc significantly improved growth , and single supplementation with iron significantly improved growth and psychomotor development , but combined supplementation with iron and zinc had no significant effect on growth or development . Combined , simultaneous supplementation with iron and zinc to infants can not be routinely recommended at the iron-to-zinc ratio used in this study",
"The effects of oral iron supplementation on blood iron levels and learning achievement in 130 rural Indonesian school children were assessed in this double-blind study . The children were classified into anemic and nonanemic groups according to their initial hemoglobin and transferrin saturation levels and were r and omly assigned to either iron or placebo treatment for 3 mo . Hematological , anthropometric , and learning-achievement data were collected before ( T1 ) and after ( T2 ) the treatment period and 3 mo later . The means and st and ard deviations suggest that supplementation with 10 mg ferrous sulfate per kilogram body weight per day for 3 mo result ed in an apparent improvement in anemic subjects ' hematological status and learning-achievement scores . No tests of statistical comparisons are reported",
"A variety of aspects of psychomotor function were assessed in 47 women before and after iron therapy . These women , all of whom had initial haemoglobin levels below 10·5 g./100 ml . , had been drawn from a population sample of 2,283 women seen at a haematological screening survey . There was no evidence of any beneficial effect of a rise in haemoglobin level on psychomotor function or on symptoms . Possibly this is because if an effect does occur it is unlikely to be apparent unless the haemoglobin level is very low . If this is true then anaemia is probably a rare cause of symptoms or impairment in psychomotor function in the community",
"Recent studies suggest that infant behavior and psychological test performance are impaired by iron deficiency and may be improved by iron . Comparable studies have not been performed in older population s. Young women early in pregnancy whose nutritional intake may be impaired by poverty constitute a high-risk population . Women aged 14 - 24 years coming for prenatal care at or before 16 weeks gestation whose hematocrits were greater than or equal to 31 % were r and omized in a double-blind trial to receive vitamins supplemented with iron ( experimental group ) or vitamins alone ( controls ) . Hematologic status and tests of short-term memory and attention span were assessed at entry and conclusion of the one-month treatment period . The experimental group showed significant improvement on the most sensitive measure of short-term memory and three subtests . On comparison of the change between initial and final scores , the experimental group showed significant or borderline greater improvement than controls on three tests . These results indicated a beneficial effect of iron therapy on psychometric test-score performance",
"OBJECTIVE . Lead exposure in children has been associated with both global and specific cognitive deficits . Although chelation therapy is advised for children with blood lead concentrations of > 44 μg/dL , treatment options for children with lower blood lead values are limited . Because lead absorption is related to children 's nutritional status , micronutrient supplements may be 1 strategy for combating low-level , chronic lead exposure . This study was design ed to test the efficacy of iron and zinc supplementation for lowering blood lead concentrations and improving cognitive performance in schoolchildren who live in a lead-contaminated city . METHODS . This r and omized , double-blind , placebo-controlled field trial was conducted in public elementary schools in Torreón , an industrialized city in northern Mexico . A metal foundry , located close to the city center and within 3.5 km of 9 schools , was the main source of lead exposure . A total of 602 children who were aged 6 to 8 years and regularly attending first grade in the study schools were enrolled . Children were given 30 mg of iron , 30 mg of zinc , both , or a placebo daily for 6 months . A total of 527 completed the treatment , and 515 were available for long-term follow-up , after another 6 months without supplementation . Eleven cognitive tests of memory , attention , visual-spatial abilities , and learning were administered at baseline and each follow-up . RESULTS . There were no consistent or lasting differences in cognitive performance among treatment groups . CONCLUSIONS . Daily supplementation with iron and /or zinc may be of limited usefulness for improving cognition in lead-exposed schoolchildren . However , these treatments may be effective in setting s with higher prevalence of nutritional deficiencies or in younger children",
"OBJECTIVE To determine the efficacy of iron and zinc supplementation on behavior ratings of lead-exposed children . STUDY DESIGN In this double-blind , r and omized trial , 602 first- grade children received 30 mg ferrous fumarate , 30 mg zinc oxide , both , or placebo daily for 6 months . Lead , iron , and zinc status were determined at baseline and follow-up . Parents and teachers provided ratings of child behavior using the Conners Rating Scales . RESULTS The baseline mean ( SD ) blood lead concentration was 11.5 ( 6.1 ) mug/dL , with 51 % of children > or = 10 microg/dL. The prevalence of attention deficit hyperactivity disorder , estimated by combined parent and teacher ratings , was 6 % . At follow-up , parent ratings of oppositional , hyperactive , cognitive problems , and attention deficit hyperactivity disorder decreased by 1.5 , 1.2 , 2.5 , and 3.4 points , respectively ( P Teacher ratings of hyperactivity increased by 1.1 points ( P = .008 ) , and the mean cognitive problem score declined by 0.7 points ( P = .038 ) . There were no treatment effects on mean change in scores , but children receiving any zinc had a higher likelihood of no longer receiving clinical ly-significant teacher ratings of oppositional behaviors . CONCLUSIONS This regimen of supplementation did not result in consistent improvements in ratings of behavior in lead-exposed children over 6 months",
"Four studies examined impacts of iron supplementation on school children of various ages and both sexes . The first study investigated impact of iron-folic acid supplements for 60 d on cognition in 94 boys and girls aged 5 - 8 y. Improvement in total scores of the anemics was significantly higher than the nonanemics in 7 - 8-y-old children only . The second study assessed impacts of supplementation on cognition in 14 pairs of 5 - 6-y-old anemic boys , with clear beneficial effects on cognitive function . The third study investigated effects of varying dosages of elemental iron on cognitive function in 48 boys aged 8 - 15 y , with different levels of improvement . The fourth study investigated impacts of iron supplementation on 163 anemic girls aged 8 - 15 y with treatment and evaluations at 4 and 8 mo , with significantly improved scores in cognitive function after the eighth month",
"This double-blind clinical trial was conducted in Thail and to assess the impact of iron treatment on the IQ and educational attainment of 1358 9 - 11-y-old children . The children were classified into one of three groups : iron replete , iron depleted , and iron-deficient anemic . The Raven Progressive Matrices was used to measure IQ . A Thai language and a math test were administered to assess school attainment . A 50-mg/d tablet of ferrous sulphate was given for 2 wk and a 100 mg/d tablet , for 14 wk . An anthelminthic drug was given on the day of the blood test before treatment and 3 mo after the intervention started . There is evidence of a positive association between iron status and IQ and a language school achievement test but there is no support for the internal validity of the hypothesis that this association is causal",
"BACKGROUND Up to 25 % of adolescent girls in the USA are iron deficient . This double-blind , placebo-controlled clinical trial assessed the effects of iron supplementation on cognitive function in adolescent girls with non-anaemic iron deficiency . METHODS 716 girls who enrolled at four Baltimore high schools were screened for non-anaemic iron deficiency ( serum ferritin Participants were r and omly assigned oral ferrous sulphate ( 650 mg twice daily ) or placebo for 8 weeks . The effect of iron treatment was assessed by question naires and haematological and cognitive tests , which were done before treatment started and repeated after the intervention . We used four tests of attention and memory to measure cognitive functioning . Intention-to-treat and per- protocol analyses were done . FINDINGS Of the 81 enrolled girls with non-anaemic iron deficiency , 78 ( 96 % ) completed the study ( 39 in each group ) . Five girls ( three control , two treatment ) developed anaemia during the intervention and were excluded from the analyses . Thus , 73 girls were included in the per- protocol analysis . Ethnic distribution , mean age , serum ferritin concentrations , haemoglobin concentrations , and cognitive test scores of the groups did not differ significantly at baseline . Postintervention haematological measures of iron status were significantly improved in the treatment group ( serum ferritin 27.3 vs 12.1 micrograms/L , p iron performed better on a test of verbal learning and memory than girls in the control group ( p this urban population of non-anaemic iron-deficient adolescent girls , iron supplementation improved verbal learning and memory"
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BACKGROUND There is considerable interest in the effectiveness of financial incentives in the delivery of health care . Incentives may be used in an attempt to increase the use of evidence -based treatments among healthcare professionals or to stimulate health professionals to change their clinical behaviour with respect to preventive , diagnostic and treatment decisions , or both . Financial incentives are an extrinsic source of motivation and exist when an individual can expect a monetary transfer which is made conditional on acting in a particular way . Since there are numerous review s performed within the healthcare area describing the effects of various types of financial incentives , it is important to summarise the effectiveness of these in an overview to discern which are most effective in changing health professionals ' behaviour and patient outcomes . OBJECTIVES To conduct an overview of systematic review s that evaluates the impact of financial incentives on healthcare professional behaviour and patient outcomes . METHODS We search ed the Cochrane Data base of Systematic Review s ( CDSR ) ( The Cochrane Library ) ; Data base of Abstract s of Review s of Effectiveness ( DARE ) ; TRIP ; MEDLINE ; EMBASE ; Science Citation Index ; Social Science Citation Index ; NHS EED ; HEED ; EconLit ; and Program in Policy Decision-Making ( PPd ) ( from their inception date s up to January 2010 ) . We search ed the reference lists of all included review s and carried out a citation search of those papers which cited studies included in the review . We included both Cochrane and non-Cochrane review s of r and omised controlled trials ( RCTs ) , controlled clinical trials ( CCTs ) , interrupted time series ( ITSs ) and controlled before and after studies ( CBAs ) that evaluated the effects of financial incentives on professional practice and patient outcomes , and that reported numerical results of the included individual studies . Two review authors independently extracted data and assessed the method ological quality of each review according to the AMSTAR criteria . We included systematic review s of studies evaluating the effectiveness of any type of financial incentive . We grouped financial incentives into five groups : payment for working for a specified time period ; payment for each service , episode or visit ; payment for providing care for a patient or specific population ; payment for providing a pre-specified level or providing a change in activity or quality of care ; and mixed or other systems . We summarised data using vote counting . MAIN RESULTS We identified four review s reporting on 32 studies . Two review s scored 7 on the AMSTAR criteria ( moderate , score 5 to 7 , quality ) and two scored 9 ( high , score 8 to 11 , quality ) . The reported quality of the included studies was , by a variety of methods , low to moderate . Payment for working for a specified time period was generally ineffective , improving 3/11 outcomes from one study reported in one review . Payment for each service , episode or visit was generally effective , improving 7/10 outcomes from five studies reported in three review s ; payment for providing care for a patient or specific population was generally effective , improving 48/69 outcomes from 13 studies reported in two review s ; payment for providing a pre-specified level or providing a change in activity or quality of care was generally effective , improving 17/20 reported outcomes from 10 studies reported in two review s ; and mixed and other systems were of mixed effectiveness , improving 20/31 reported outcomes from seven studies reported in three review s. When looking at the effect of financial incentives overall across categories of outcomes , they were of mixed effectiveness on consultation or visit rates ( improving 10/17 outcomes from three studies in two review s ) ; generally effective in improving processes of care ( improving 41/57 outcomes from 19 studies in three review s ) ; generally effective in improving referrals and admissions ( improving 11/16 outcomes from 11 studies in four review s ) ; generally ineffective in improving compliance with guidelines outcomes ( improving 5/17 outcomes from five studies in two review s ) ; and generally effective in improving prescribing costs outcomes ( improving 28/34 outcomes from 10 studies in one review ) . AUTHORS ' CONCLUSIONS Financial incentives may be effective in changing healthcare professional practice . The evidence has serious method ological limitations and is also very limited in its completeness and generalisability . We found no evidence from review s that examined the effect of financial incentives on patient outcomes
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"We used a resident continuity clinic to compare prospect ively the impact of salary v fee-for-service reimbursement on physician practice behavior . This model allowed r and omization of physicians into salary and fee-for-service groups and separation of the effects of reimbursement from patient behavior . Physicians reimbursed by fee-for-services scheduled more visits per patient than did salaried physicians ( 3.69 visits v 2.83 visits , P less than .01 ) and saw their patients more often ( 2.70 visits v 2.21 visits , P less than .05 ) during the 9-month study . Almost all of this difference was because fee-for-service physicians saw more well patients than salaried physicians ( 1.42 visits and .99 visits per enrolled patient , respectively , P less than .01 ) . Evaluating visits by American Academy of Pediatrics ' guidelines indicated that fee-for-service physicians saw more patients for well-childcare than salaried physicians because they missed fewer recommended visits and scheduled visits in excess of those recommendations . Fee-for-service physicians also provided better continuity of care than salaried physicians by attending a larger percentage of all visits made by their patients ( 86.6 % of visits v 78.3 % of visits , P less than .05 ) , and by encouraging fewer emergency visits per enrolled patient ( 0.12 visits v 0.22 visits , P less than .01 ) . Physicians ' interest in private practice , as determined by their career plans , correlated significantly with total number of patients enrolled ( r = .48 , P less than .05 ) and total clinic patients seen by each resident during the study ( r = .40 , P less than .05 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Background The implementation of new medical knowledge into general practice is a complex process . Blended learning may offer an effective and efficient educational intervention to reduce the knowledge-to- practice gap . The aim of this study was to compare knowledge acquisition about dementia management between a blended learning approach using online modules in addition to quality circles ( QCs ) and QCs alone . Methods In this cluster-r and omised trial with QCs as clusters and general practitioners ( GPs ) as participants , 389 GPs from 26 QCs in the western part of Germany were invited to participate . Data on the GPs ' knowledge were obtained at three points in time by means of a question naire survey . Primary outcome was the knowledge gain before and after the interventions . A subgroup analysis of the users of the online modules was performed . Results 166 GPs were available for analysis and filled out a knowledge test at least two times . A significant increase of knowledge was found in both groups that indicated positive learning effects of both approaches . However , there was no significant difference between the groups . A subgroup analysis of the GPs who self-reported that they had actually used the online modules showed that they had a significant increase in their knowledge scores . Conclusion A blended learning approach was not superior to a QCs approach for improving knowledge about dementia management . However , a subgroup of GPs who were motivated to actually use the online modules had a gain in knowledge . Trial registration Current Controlled Trials IS RCT N36550981",
"Objective . Immunizations and other cost-effective preventive services remain underused by many children , especially those living in poverty . Given the effectiveness of provider-based tracking systems and the widespread use by managed care organizations of financial incentives to influence physician practice patterns , we design ed and tested an intervention combining these strategies . We studied whether a system of semiannual assessment and feedback , coupled with financial incentives , could improve pediatric preventive care in a Medicaid health maintenance organization ( HMO ) . Methodology . We r and omly assigned primary care sites serving children in a Medicaid HMO to one of three groups : a feedback group ( where physicians received written feedback about compliance scores ) , a feedback and incentive group ( where physicians received feedback and a financial bonus when compliance criteria were met ) , and a control group . We evaluated compliance with pediatric preventive care guidelines through semiannual chart audits during the years 1993 to 1995 . Results . Compliance with pediatric preventive care improved dramatically in the study period . Repeated measures ANOVA demonstrated a significant increase in all three study groups throughout the time in total compliance scores ( from 56%–73 % ) , as well as scores for immunizations ( from 62%–79 % ) and other preventive care ( from 54%–71 % ) . However , no significant differences were observed between either intervention group and the control group , nor were there any interaction ( group-by-time ) effects . Conclusions . Feedback to physicians , with or without financial incentives , did not improve pediatric preventive care in this Medicaid HMO during a time of rapid , secular improvements in care . Possible explanations include the context and timing of the intervention , the magnitude of the financial incentives , and lack of physician awareness of the intervention",
"OBJECTIVE To determine the effects of a financial incentive on the number and types of cognitive services ( CS ) provided by community pharmacies to Medicaid recipients in the State of Washington . DESIGN Prospect i ve r and omized trial . CS were reported using a problem-intervention- result coding system over a 20-month period . SETTING AND SUBJECTS Pharmacists practicing in 110 study ( financial incentive ) and 90 control community pharmacies . RESULTS Study pharmacists documented an average of 1.59 CS interventions per 100 prescriptions over a 20-month period , significantly more than controls , who documented an average of 0.67 interventions ( P change in drug therapy occurred as a result of 28 % of all CS documented in this demonstration . Changes were rarely ( 2.4 % ) due to generic or therapeutic substitution and almost always ( 90 % ) followed communication with the prescriber . The average self-reported time to perform CS was 7.5 minutes ; 75 % of interventions were types of problems identified , intervention activities performed , and results of interventions . CONCLUSION A financial incentive was associated with significantly more , and different types of , CS performed by pharmacists",
"Background Health risk appraisal is a promising method for health promotion and prevention in older persons . The Health Risk Appraisal for the Elderly ( HRA-E ) developed in the U.S. has unique features but has not been tested outside the United States . Methods Based on the original HRA-E , we developed a scientifically up date d and regionally adapted multilingual Health Risk Appraisal for Older Persons ( HRA-O ) instrument consisting of a self-administered question naire and software-generated feed-back reports . We evaluated the practicability and performance of the question naire in non-disabled community-dwelling older persons in London ( U.K. ) ( N = 1090 ) , Hamburg ( Germany ) ( N = 804 ) , and Solothurn ( Switzerl and ) ( N = 748 ) in a sub- sample of an international r and omised controlled study . Results Over eighty percent of invited older persons returned the self-administered HRA-O question naire . Fair or poor self-perceived health status and older age were correlated with higher rates of non-return of the question naire . Older participants and those with lower educational levels reported more difficulty in completing the HRA-O question naire as compared to younger and higher educated persons . However , even among older participants and those with low educational level , more than 80 % rated the question naire as easy to complete . Prevalence rates of risks for functional decline or problems were between 2 % and 91 % for the 19 HRA-O domains . Participants ' intention to change health behaviour suggested that for some risk factors participants were in a pre-contemplation phase , having no short- or medium-term plans for change . Many participants perceived their health behaviour or preventative care uptake as optimal , despite indications of deficits according to the HRA-O based evaluation . Conclusion The HRA-O question naire was highly accepted by a broad range of community-dwelling non-disabled persons . It identified a high number of risks and problems , and provided information on participants ' intention to change health behaviour",
"OBJECTIVE --To investigate the effects on general practitioners ' activities of a change in their remuneration from a capitation based system to a mixed fee per item and capitation based system . DESIGN --Follow up study with data collected from contact sheets completed by general practitioners in one period before ( March 1987 ) a change in their remuneration system and two periods after ( March 1988 , November 1988 ) , with a control group of general practitioners with a mixed fee per item and capitation based system throughout . SETTING --General practice s in Copenhagen city ( index group ) and Copenhagen county ( control group ) . SUBJECTS--265 General practitioners in Copenhagen city , of whom 100 were selected r and omly from the 130 who agreed to participate ( 10 exclusions ) and 326 general practitioners in Copenhagen county . MAIN OUTCOME MEASURES --Number of consultations ( face to face and by telephone ) and renewals of prescriptions , diagnostic and curative services , and specialist and hospital referrals per 1000 enlisted patients in one week . RESULTS --Of the 75 general practitioners who completed all three sheets , four were excluded for incomplete data . Total contact rates per 1000 patients listed rose significantly compared with the rates before the change index in the city ( 100.0 before the change v 111.7 ( 95 % confidence interval 106.4 to 117.4 after the change ) and over the same time in the control group ( 100.0 v 106.0 ) , but within a year these rates fell ( to 104.2(99.1 to 109.6 ) and 104.0 respectively ) . There was an increase in consultations by telephone initially but not thereafter . Rates of examinations and treatments that attracted specific additional remuneration after the change rose significantly compared with those before ( diagnostic services , 138.1 ( 118.7 to 160.5 ) and 159.5 ( 137.8 to 184.7 ) and curative services 194.6 ( 152.2 to 248.9 ) and 194.8(152.3 to 249.2 ) for second and third data collection s respectively ) and with the control group ( diagnostic services 105.3 , 107.6 and curative services 106.0 , 115.0 ) whereas referral rates to secondary care fell ( specialist referrals 90.1 ( 80.7 to 100.6 ) and 77.0 ( 68.6 to 86.4 ) and hospital referrals 87.4 ( 71.1 to 107.5 ) and 68.4 ( 54.7 to 85.4 ] in doctors in the city . CONCLUSIONS --Introducing a partial fee for service system seemed to stimulate the provision of services by general practitioners , result ing in reduced referral rates . The concept of a \" target income \" which doctors aim at , rather than maximising their income seemed to play a part in adjustment to changing the system of remuneration",
"OBJECTIVE This study determined the effect of 2 financial incentives --- bonus and enhanced fee-for-service --- on documented immunization rates during a second period of observation . METHODS Incentives were given to 57 r and omly selected inner-city physicians 4 times at 4-month intervals based on the performance of 50 r and omly selected children . Coverage from linked records from all sources was determined for a sub sample of children within physician offices . RESULTS Up-to- date coverage rates documented in the charts increased significantly for children in the bonus group ( 49.7 % to 55.6 % ; P enhanced fee-for-service group ( 50.8 % to 58.2 % ; P control group . The number of immunizations given by these physicians did not change significantly , although the number of immunizations given by others and documented by physicians in the bonus group did increase ( P Up-to- date coverage for all groups increased from 20 to 40 percentage points when immunizations from physician charts were combined with other sources . CONCLUSIONS Both financial incentives produced a significant increase in coverage levels . Increases were primarily due to better documentation not to better immunizing practice s. The financial incentives appeared to provide motivation to physicians but were not sufficient to overcome entrenched behavior patterns . However , true immunization coverage was substantially higher than that documented in the charts",
"BACKGROUND This study tested the effects of two organizational support processes , the provision of financial incentives for superior clinical performance and the availability of a patient ( smoker ) registry and proactive telephone support system for smoking cessation , on provider adherence to accepted practice guidelines and associated patient outcomes . METHODS Forty clinics of a large multispecialty medical group practice providing primary care services were r and omly allocated to study conditions . Fifteen clinics each were assigned to the experimental conditions \" control \" ( distribution of printed versions of smoking cessation guidelines ) and \" incentive \" ( financial incentive pay-out for reaching preset clinical performance targets ) . Ten clinics were r and omized to receive financial incentives combined with access to a central ized patient registry and intervention system ( \" registry \" ) . Main outcome measures were adherence to smoking cessation clinical practice guidelines and patients ' smoking cessation behaviors . RESULTS Patients ' tobacco use status was statistically significant ( P accessed counseling programs statistically significantly more often ( P financial incentives and a patient registry/intervention system in improving smoking cessation clinical practice s and patient behaviors was mixed . Additional research is needed to identify conditions under which such organizational support processes result in significant health care quality improvement and warrant the investment",
"OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity",
"OBJECTIVES A r and omized controlled trial evaluated the impact of feedback and financial incentives on physician compliance with cancer screening guidelines for women 50 years of age and older in a Medicaid health maintenance organization ( HMO ) . METHODS Half of 52 primary care sites received the intervention , which included written feedback and a financial bonus . Mammography , breast exam , colorectal screening , and Pap testing compliance rates were evaluated . RESULTS From 1993 to 1995 , screening rates doubled overall ( from 24 % to 50 % ) , with no significant differences between intervention and control group sites . CONCLUSIONS Financial incentives and feedback did not improve physician compliance with cancer screening guidelines in a Medicaid HMO",
"BACKGROUND An earlier paper published in this journal suggested that fundholding practice s in Lincolnshire had managed to constrain the growth in their prescribing costs more successfully than had non-fundholders , largely on the basis of restricting the number of items prescribed per patient . At that time , insufficient data were available to explore the impact of a change in status from non-fundholding to fundholding on prescribing behaviour . METHOD Time-series prescribing data for the fourth-wave of Lincolnshire fundholders are analysed , and comparisons are made between this group , non-fundholders and the fundholders of the earlier waves . RESULTS In their first year of fundholding , fourth-wave practice s adopted the prescribing strategies employed previously by existing fundholders , namely , reductions in the number of items prescribed per patient and substantial increases in generic prescribing . The hypothesis that prospect i ve fundholders inflate their prescribing budget before attaining fundholding status is not generally supported by the Lincolnshire data . Evidence is presented which suggests that the prescribing cost economies accruing to fundholding status may be short term . CONCLUSIONS With the acquisition of fundholding status , the structure of incentives facing practice s changes . Our results suggest that , with respect to prescribing , practice s adjust rapidly to the new incentive structure",
"Abstract Objective : To examine possible differential changes in outpatient referrals to orthopaedic clinics , attendances , and waiting times between fundholding and non-fundholding general practitioners . Design : Observational controlled study of referrals by general practitioners to orthopaedic out patients between April 1991 and March 1995 . Setting : District health authority in south west Engl and . Subjects : 10 fundholding practice s with 108 300 registered patients ; 22 control practice s with 159 900 registered patients . Main outcome measures : Changes in age st and ardised referral and outpatient attendance ratios for the year before and the two years after achieving fundholder status ; changes in outpatient waiting times . Results : In the year before achieving fundholding status both groups were referring more patients than were being seen . Two years later , referral and attendance ratios had increased by 13 % and 36 % respectively for fundholders and 32 % and 59 % for controls , and both groups were referring fewer patients than were being seen . Attendances represented 112 % of referrals for fundholders and 104 % for controls . In 1991 - 2 , a similar proportion of patients in the two groups was seen within three months of referral . The two hospitals that set up specific clinics exclusively for fundholders showed faster access for patients of fundholders by 1993 - 4 , as did a third hospital without such clinics by 1994 - 5 . Conclusions : Fundholders increased their orthopaedic referrals less than did controls and achieved a better balance between outpatient appointments and referrals . Their patients were likely to be seen more quickly , particularly if the hospital provided special clinics exclusively for fundholders . Lack of case mix information makes it impossible to judge whether these differences benefit or disadvantage patients . Key messages Patients of fundholders had no better access than patients of non-fundholders to orthopaedic services before the practice s became fundholding Fundholders controlled their referrals better than non-fundholders and achieved a better balance between referrals and attendances Fundholders ' patients were more likely to be seen quickly , especially if the receiving hospital laid on specific clinics exclusively for fundholders Information on case mix is needed to identify whether the lower referral rate among fundholders benefits or disadvantages",
"This paper is a report of the results of a demonstration design ed to provide empirical evidence regarding the effects of alternative approaches to paying physicians for serving children in the Medicaid program : ( 1 ) visit fees set at twice regular Medicaid fees in return for physician agreement to manage utilization and ( 2 ) capitation and financial risk-sharing along with the same physician agreement to manage utilization . Participating physicians were assigned r and omly to either of the two payment groups . Comparisons of utilization and expenditures were made between these two plans and the regular Medicaid program ( fee-for-service , low fees ) . Results showed no adverse effect of capitation payments on primary care visits to office-based physicians . Capitation physician referrals to specialists decreased relative to all other groups studied , consistent with the theory that the financial incentives in capitation will lead primary care physicians to reduce referrals to specialists",
"OBJECTIVE To investigate the effect of performance-based financial incentives on the influenza immunization rate in primary care physicians ' offices . DESIGN R and omized controlled trial during the 1991 influenza immunization season . SETTING Rochester , New York , and surrounding Monroe County during the Medicare Influenza Vaccine Demonstration Project . PARTICIPANTS A total of 54 solo or group practice s that had participated in the 1990 Medicare Demonstration Project . INTERVENTIONS All physicians in participating practice s agreed to enumerate their ambulatory patients aged 65 or older who had been seen during the 1990 or 1991 calendar years , and to track the immunization rate on a weekly basis using a specially design ed poster from September 1991 to January 1 , 1992 . Additionally , physicians agreed to be r and omized , by practice group , to the control group or to the incentive group , which could receive an additional $ .80 per shot or $ 1.60 per shot if an immunization rate of 70 % or 85 % , respectively , was attained . MEASUREMENTS The main outcome measures are the 1991 immunization rate and the improvement in immunization rate from the 1990 to 1991 influenza seasons for each group practice . RESULTS For practice s in the incentive group , the mean immunization rate was 68.6 % ( SD 16.6 % ) compared with 62.7 % ( SD 18.0 % ) in the control group practice s ( P = .22 ) . The median practice -specific improvement in immunization rate was + 10.3 % in the incentive group compared with + 3.5 % in the control group ( P = .03 ) . CONCLUSIONS Despite high background immunization rates , this modest financial incentive was responsible for approximately 7 % increase in immunization rate among the ambulatory elderly",
"Serving people with mental and other chronic illnesses in community setting s may improve compliance and satisfaction with treatment , but existing payment mechanisms often favor office-based treatment . This study examines the effect of a change in Medicaid payment on the location and amount of service provided by case managers . Amounts of service given by treatment providers to 185 of their clients in community setting s and in mental health centers were compared before and after reimbursement changed from an all-inclusive prospect i ve rate to a mixed prospect ive/retrospective payment . Clients were enrolled in two different treatment programs : continuous treatment teams with extensive training in in vivo treatment , and a case management program that emphasized office-based treatment . In-community service increased , and the amount of office-based treatment decreased . Continuous treatment teams increased in-community services more than case managers did ; case managers decreased office-based treatment more . There was no change in total amount of services provided . It was concluded that mixed prospect i ve and retrospective reimbursement can remove financial barriers to in-community treatment , but it works best in combination with a training program . Additional research is needed to determine the precise financial impact of such changes",
"BACKGROUND This 1-year r and omized trial tested the efficacy of behavioral techniques for increasing mammography referrals by primary care physicians in small , community practice s. METHODS Sixty-one practice s were r and omly assigned to one of three conditions : ( 1 ) education-only control , ( 2 ) education plus cue enhancement using mammography chart stickers , and ( 3 ) education plus cue enhancement plus feedback and token rewards . Quarterly chart audits of a defined sample ( N = 11,716 ) of women patients 50 years of age or older were conducted to document mammography referrals , completions , and compliance . RESULTS Referral and completion rates increased from baseline to first quarter and gradually declined thereafter . Overall , these rates were higher in the cuing conditions than in the control condition . In contrast , compliance rates in both experimental conditions increased over the year while remaining static in the control condition , demonstrating a strong and continuing effect for cue enhancement . Compliance increases were greatest for physicians who were older , nonwhite , with a second speciality , in solo practice , not members of the AMA , not residency trained , and not board certified . CONCLUSIONS Chart stickers can significantly increase mammography utilization in small , community practice s. These practice s are an efficient route to reaching large numbers of older women in need of mammography screening",
"OBJECTIVES The purpose of this study was to examine the effects on immunization coverage of 3 incentives for physicians -- a cash bonus for practice --wide increases , enhanced fee for service , and feedback . METHODS Incentives were applied at 4-month intervals over 1 year among 60 inner-city office-based pediatricians . At each interval , charts of 50 r and omly selected children between 3 and 35 months of age were review ed per physician . RESULTS The percentage of children who were up to date for diphtheria , tetanus , and pertussis and Haemophilus influenzae type b ; polio ; and measles-mumps-rubella immunization in the study 's bonus group improved by 25.3 percentage points ( P percentage of immunizations received outside the participating practice also increased significantly in the bonus group ( P Levels of missed opportunities to immunize were high in all groups and did not change over time . Physicians ' knowledge of contraindications was low . CONCLUSIONS Bonuses sharply and rapidly increased immunization cover-age in medical records . However , much of the increase was the result of better documentation . A bonus is a powerful incentive , but more structure or education may be necessary to achieve the desired results"
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BACKGROUND The U.S. Preventive Services Task Force ( USPSTF ) has recommended screening and behavioral counseling interventions in primary care to reduce alcohol misuse . This study was design ed to develop a st and ardized rating for the clinical ly preventable burden and cost effectiveness of complying with that recommendation that would allow comparisons across many recommended services . METHODS A systematic review of the literature from 1992 through 2004 to identify relevant r and omized controlled trials and cost-effectiveness studies was completed in 2005 . Clinical ly preventable burden ( CPB ) was calculated as the product of effectiveness times the alcohol-attributable fraction of both mortality and morbidity ( measured in quality -adjusted life years or QALYs ) , for all relevant conditions . Cost effectiveness from both the societal perspective and the health-system perspective was estimated . These analyses were completed in 2006 . RESULTS The calculated CPB was 176,000 QALYs saved over the lifetime of a birth cohort of 4,000,000 , with a range in sensitivity analysis from -43 % to + 94 % ( primarily due to variation in estimates of effectiveness ) . Screening and brief counseling was cost-saving from the societal perspective and had a cost-effectiveness ratio of $ 1755/QALY saved from the health-system perspective . Sensitivity analysis indicates that from both perspectives the service is very cost effective and may be cost saving . CONCLUSIONS These results make alcohol screening and counseling one of the highest-ranking preventive services among the 25 effective services evaluated using st and ardized methods . Since current levels of delivery are the lowest of comparably ranked services , this service deserves special attention by clinicians and care delivery systems
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"OBJECTIVE This study was design ed to conduct a r and omized controlled trial of motivational enhancement therapy ( MET ) with two control conditions : nondirective reflective listening ( NDRL ) and no further counseling ( NFC ) ; and to conduct this study in a sample of patients with a primary diagnosis of mild to moderate alcohol dependence , in a \" real-life \" clinical setting . METHOD Patients with mild to moderate alcohol dependence were recruited , assessed and treated at the Community Alcohol and Drug Service of Christchurch , New Zeal and . All patients received a feedback/education session before r and omization to either four sessions of MET , four sessions of NDRL , or NFC . Outcome data on 122 subjects ( 57.4 % men ) were obtained 6 months following the end of treatment , by an interviewer who was blind to the treatment condition . The primary drinking outcome was unequivocal heavy drinking , defined as drinking 10 or more st and ard drinks six or more times in the follow-up period . Global assessment scale ( GAS ) measured general personal/social functioning . RESULTS Of patients treated with MET , 42.9 % showed unequivocal heavy drinking compared with 62.5 % of the NDRL and 65.0 % of the NFC groups ( p = .04 ) . No significant differences were found for GAS score according to treatment condition . CONCLUSIONS In patients with mild to moderate alcohol dependence , MET is more effective for reducing unequivocal heavy drinking than either a feedback/education session alone or four sessions of NDRL . MET can be considered an effective \" value added \" counseling intervention in a real-life clinical setting . In patients with mild to moderate alcohol dependence , nondirective reflective listening provides no additional advantage over a feedback/education session alone",
" Seventy two women drinking 21 units ( 210 g ) or more of alcohol per week were recruited from an opportunistic screening programme in eight English general practice s. The women were r and omized into control and treatment groups . Women in the treatment group received ten minutes advice from their general practitioner to reduce alcohol consumption . At one year follow-up , when analyzed by intention to treat , women in the treatment group had reduced their alcohol consumption from an average of 35 - 24 units per week . Similar reductions were found in the control group ( from 37 - 27 units per week ) . The lack of evidence for a treatment effect may be explained by contamination of the control group by informal interventions",
"Abstract The effects of a primary prevention social norm intervention on binge drinking among 1st-year residential college students were examined . Six hundred thirty-four students attending a medium-sized public university in the South were r and omly assigned to receive a two-phase social norm intervention or the st and ard campus psychoeducational prevention program . At posttest , no differences were found between intervention and control group students on any of the alcohol use and alcohol-use risk factor measures . Significant subgroup differences were found by stage of initiating binge drinking behaviors , for frequency of alcohol use , F(3 , 507 ) = 3.69 , p = .01 ; quantity of alcohol use , F(3 , 507 ) = 2.51 , p = .05 ; and social norms , F(3 , 505 ) = 2.53 , p = .05 . These findings suggest the need for tailoring social norm binge drinking interventions to students ' stage of initiating heavy drinking and carefully monitoring for potential negative , as well as positive , effects of norm-based prevention messages",
"In a controlled evaluation of general practitioner (GP)-based brief intervention , 378 excessive drinkers identified opportunistically by screening in 40 group practice s in metropolitan Sydney were assigned to groups receiving : ( i ) a five-session intervention by the GP ( the Alcoholscreen Program ) ; ( ii ) a single session of 5 minutes ' advice by the GP plus a self-help manual ( minimal intervention ) ; ( iii ) an alcohol-related assessment but no intervention ; ( iv ) neither intervention nor assessment . Among all patients allocated to receive it , the Alcoholscreen Program did not result in a significantly greater reduction in consumption at follow-up than control conditions but patients offered Alcoholscreen reported a significantly greater reduction in alcohol-related problems in the period to 6 months follow-up . A greater proportion of patients who returned for the second Alcoholscreen visit were drinking below recommended levels at follow-up than in the remainder of the sample . There was no evidence that minimal intervention or alcohol-related assessment were effective in reducing alcohol consumption or problems . Implication s for further research into GP-based brief interventions are discussed",
"OBJECTIVE To compare the effects of three brief methods of reducing alcohol consumption among family practice patients . DESIGN Patients r and omly assigned to one of three interventions were assessed initially and at 3- , 6- , and 12-month follow-up appointments . SETTING Family practice clinic composed of 12 primary care physicians seeing approximately 6000 adults monthly in a small urban community , population 40,000 . PARTICIPANTS Through a screening question naire , 134 men and 131 women were identified as hazardous drinkers ( five or more drinks at least once monthly ) during an 11-month screening of 1420 patients . Of 265 patients approached , 180 agreed to participate and 159 ( 83 men and 76 women ) actually participated in the study . INTERVENTIONS Three interventions were studied : brief physician advice ( 5 minutes ) , two 30-minute sessions with a physician using cognitive behavioural strategies or two 30-minute sessions with a nurse practitioner using identical strategies . MAIN OUTCOME MEASURES Quantity and frequency ( QF ) of drinking were used to assess reduction in hazardous drinking and problems related to drinking over 12 months of follow up . RESULTS No statistical difference between groups was found . The QF of monthly drinking was reduced overall by 66 % ( among men ) and 74 % ( among women ) for those reporting at least one hazardous drinking day weekly at assessment ( N = 96 ) . Men reported drinking significantly more than women . CONCLUSIONS These results indicated that offering brief , specific advice can motivate patients to reduce their alcohol intake . There was no difference in effect between brief advice from their own physician or brief intervention by a physician or a nurse",
"Sixteen general practitioners participated in a controlled trial of the Scottish Health Education Group 's DRAMS ( drinking reasonably and moderately with self-control ) scheme . The scheme was evaluated by r and omly assigning 104 heavy or problem drinkers to three groups - a group participating in the DRAMS scheme ( n = 34 ) , a group given simple advice only ( n = 32 ) and a non-intervention control group ( n = 38 ) . Six month follow-up information was obtained for 91 subjects ( 87.5 % of initial sample ) . There were no significant differences between the groups in reduction in alcohol consumption , but patients in the DRAMS group showed a significantly greater reduction in a logarithmic measure of serum gamma-glutamyl-transpeptidase than patients in the group receiving advice only . Only 14 patients in the DRAMS group completed the full DRAMS procedure . For the sample as a whole , there was a significant reduction in alcohol consumption , a significant improvement on a measure of physical health and well-being , and significant reductions in the logarithmic measure of serum gamma-glutamyl transpeptidase and in mean corpuscular volume . The implication s of these findings for future research into controlled drinking minimal interventions in general practice are discussed",
"OBJECTIVE : To determine effectiveness of advice from general practitioners to heavy drinkers to reduce their excessive alcohol consumption ( 35 U or more a week for men , 21 U or more for women ) . DESIGN : R and omised , controlled double blind trial over 12 months with interim assessment at six months . SETTING : Group practice s ( n = 47 ; list size averaging 10,000 ) recruited from Medical Research Council 's general practice research framework , mostly in rural or small urban setting s. PATIENTS : Patients recruited after question naire survey . Of total of 2571 ( 61.2 % ) of 4203 patients invited for interview who attended , 909 ( 35.4 % ) stated that in past seven days they had drunk above the limits set for study and had not received advice ; they were r and omised to control and treatment groups . INTERVENTIONS : Patients in treatment group were interviewed by general practitioner ( who had had a training session ) and received advice and information about how to reduce consumption and also given a drinking diary . END POINT : Study aim ed at detecting a reduction in proportion of men with excessive alcohol consumption of 30 % in treatment group and 20 % in control group ( for women 40 % and 20 % , respectively ) with a power of 90 % at 5 % level of significance . In addition , corroborative measures such as estimation of gamma-glutamyltransferase activity were included . MEASUREMENTS AND MAIN RESULTS : At one year a mean reduction in consumption of alcohol of 18.2 ( SE 1.5 ) U/week had occurred in treated men compared with a reduction of 8.1 ( 1.6 ) U/week in controls ( p less than 0.001 ) . The proportion of men with excessive consumption at interview had dropped by 43.7 % in the treatment group compared with 25.5 % in controls ( p less than 0.001 ) . A mean reduction in weekly consumption of 11.5 ( 1.6 ) U occurred in treated women compared with 6.3 ( 2.0 ) U in controls ( p less than 0.05 ) , with proportionate reductions of excessive drinkers in treatment and control groups of 47.7 % and 29.2 % respectively . Reduction in consumption increased significantly with number of general practitioner interventions . At one year the mean value for gamma-glutamyltransferase activity had dropped significantly more in treated men ( -2.4 (0.9)IU/l ) than in controls ( + 1.1(1.0)IU/l ; t = 2.7 , p less than 0.01 ) . Reduction in gamma-glutamyltransferase activity tended to increase with number of intervention sessions in men . Changes in gamma-glutamyltransferase activity in women and changes in other indicators in both sexes did not differ significantly between treatment and control groups . CONCLUSIONS : If the results of this study were applied to the United Kingdom intervention by general practitioners could each year reduce to moderate levels the alcohol consumption of some 250000 men and 67500 women who currently drink to excess . General practitioners and other members of the primary health care team should therefore be encouraged to include counselling about alcohol consumption in their preventive activities",
"Recognizing the need to offer alternative methods of brief interventions , this study developed correspondence treatments for low-dependent problem drinkers and evaluated their impact . One hundred and twenty-one problem drinkers were recruited by media advertisements and were r and omly allocated to a full cognitive-behavioural treatment programme ( CBT ) or to a minimal intervention condition ( MI ) that gave information regarding alcohol misuse and instructions to record drinking++ . As predicted , CBT was more effective than MI in reducing alcohol consumption over the 4-month controlled trial period . CBT produced a 50 % fall in consumption , bringing the average intake of subjects within recommended maximum levels . Treatment gains at 6 months were well maintained to 12 months . High levels of consumer satisfaction , a high representation of women and a substantial participation from isolated rural areas attested to the feasibility of the correspondence programme as an alternative treatment . However , some drinking occasions still involved high intake for a significant subgroup of subjects , and this issue will be addressed in future programmes . The results supported the use of correspondence delivery as a means of promoting early engagement and equity of access between city and country areas",
"BACKGROUND Alcohol use in older adults is common . It is associated with depression , hypertension , diabetes , drug interactions , accidents , and increased rates of emergency department visits and hospitalizations . METHODS A controlled clinical trial ( Project GOAL --Guiding Older Adult Lifestyles ) tested the efficacy of brief physician advice in reducing the alcohol use and use of health care services of older adult problem drinkers . Twenty-four community-based primary care practice s in Wisconsin ( 43 family physicians and internists ) participated in the trial . Of the 6073 patients screened , 105 men and 53 women met inclusion criteria and were r and omized into a control group ( n = 71 ) or an intervention group ( n = 87 ) . Intervention group patients received two 10- to 15-minute physician-delivered counseling sessions that included advice , education , and contracting using a scripted workbook . A total of 146 patients ( 92.4 % ) participated in the 12-month follow-up procedure . RESULTS No significant differences were found between the control and intervention groups at baseline in alcohol use , age , socioeconomic status , depression , onset of alcohol use , smoking status , activity level , or use of mood-altering drugs . The older adults who received the physician intervention demonstrated a significant reduction in 7-day alcohol use , episodes of binge drinking , and frequency of excessive drinking ( P 7-day alcohol use , 74 % reduction in mean number of binge-drinking episodes , and 62 % reduction in the percentage of older adults drinking more than 21 drinks per week in the intervention group compared with the control group . There were no significant changes in health status . Patterns of health care utilization were not extensively analyzed because of the small number of events . CONCLUSIONS This study provides the first direct evidence that brief physician advice can decrease alcohol use by older adults in community-based primary care practice",
"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",
"AIMS Evaluate effectiveness and costs of brief interventions for patients screening positive for at-risk drinking in managed health care organizations ( MCOs ) . METHODS A pre-post , quasi-experimental , multi-site evaluation conducted at 15 clinic sites within five MCO setting s. At-risk drinkers ( N = 1329 ) received either : ( i ) brief intervention delivered by licensed practitioners ; or ( ii ) brief intervention delivered by mid-level professional specialists ( nurses ) ; or ( iii ) usual care ( comparison condition ) . Clinics were r and omly assigned to three study conditions . Data were collected on the cost of screening and brief intervention . Follow-up interviews were conducted at 3 and 12 months . RESULTS Participants in all three study conditions were drinking significantly less at 3-month follow-up , but the decline was significantly greater in the two intervention groups than in the control group . There were no significant differences between the two intervention conditions . Of the patients in the intervention conditions 60 % reduced their alcohol consumption by > or = 1 drink per week , compared with 53 % of those in the control condition . No differences were found on a measure of the quality of life . Differential reductions in weekly alcohol consumption between intervention and control groups were significant at 12-month follow-up . Average incremental costs of the interventions were 4.16 US dollar per patient using licensed practitioners and 2.82 US dollar using mid-level specialists . CONCLUSION Alcohol screening and brief intervention when implemented in managed care organizations produces modest , statistically significant reductions in at-risk drinking . Interventions delivered to a common protocol by mid-level specialists are as effective as those delivered by licensed practitioners at about two-thirds the cost",
"The authors evaluated the efficacy of Brief Alcohol Screening and Intervention for College Students ( BASICS - L. A. Dimeff , J. S. Baer , D. R. Kivlahan , & G. A. Marlatt , 1999 ) , a single session of drinking-related feedback intended to reduce heavy drinking and related harm . College student drinkers ( N = 99 ) were assigned to BASICS , an educational intervention , or an assessment -only control group . At 3 months postintervention . there were no overall significant group differences , but heavier drinking BASICS participants showed greater reductions in weekly alcohol consumption and binge drinking than did heavier drinking control and education participants . At 9 months , heavier drinking BASICS participants again showed the largest effect sizes . BASICS participants evaluated the intervention more favorably than did education participants . This study suggests that BASICS may be more efficacious than educational interventions for heavier drinking college students",
"Objectives The purpose of this study was to explore the efficacy in a primary care setting of a telephone-based disease management program for the acute management of depression and /or at-risk drinking . Material s and Methods Veterans ( N = 97 ) with depression and /or at-risk drinking were identified by systematic screening and assessment . Eligible subjects received either telephone disease management ( TDM ) program or usual care based on r and om assignment of their clinician . The TDM program consisted of regular contacts with each subject by a behavioral health specialist ( BHS ) to assist in assessment , education , support , and treatment planning . Symptomatic outcomes were assessed at 4 months . Results Overall response rates favored those assigned to TDM compared with those assigned to usual care ( 39.1 % responded vs. 17.6 % , p = 0.022 ) . Response rates within the separate diagnostic groups also favored TDM , but this was only significant for depressive disorders . Conclusions Although the sample size was modest and the sample was limited to veterans , findings strongly suggest that a telephone-based disease management program can improve outcomes for patients with a behavioral health problem . Findings also suggest that a health specialist can focus and manage patients with different diagnoses , thus exp and ing the role beyond just depression care . TDM may be a viable , low-cost , model for primary care clinicians to deliver manual guideline -adherent behavioral health care , especially in a VA clinical setting",
"This study tested two forms of alcohol reduction programming for college students . Thirty-seven moderate to heavy drinkers completed measures of quantity/frequency , drinking consequences , and attitude question naires . Participants were r and omly assigned to one of three groups : 1 ) a two-hour information and motivation session plus mailed personal feedback on their drinking ; 2 ) mailed feedback only ; or 3 ) no treatment . At a 6-week follow-up session , the feedback-only group decreased drinks per month as compared to control . No other differences were statistically significant , though decreases favored the treatment conditions about equally over control . Implication s for research and treatment are discussed",
"BACKGROUND Studies suggest that 14 % of women age 18 to 40 drink alcohol above recommended limits . Of special concern is the increasing use of alcohol by women during pregnancy . This article reports 48 month follow-up data from a sub analysis of a trial for early alcohol treatment ( Project TrEAT ) focused on women of childbearing age . METHODS Project TrEAT was conducted in the offices of 64 primary care , community-based physicians from 10 Wisconsin counties . Of 5979 female patients ages 18 to 40 who were screened for problem drinking , 205 were r and omized into an experimental group ( n = 103 ) or control group ( n = 102 ) . The intervention consisted of two 15 min , physician-delivered counseling visits that included advice , education , and contracting by using a scripted workbook . A total of 174 subjects ( 85 % ) completed the 48 month follow-up procedures . RESULTS No significant differences were found between the experimental and control groups at baseline for alcohol use , age , socioeconomic status , smoking , depression or anxiety , conduct disorder , lifetime drug use , or health care utilization . The trial found a significant treatment effect in reducing both 7 day alcohol use ( p = 0.0039 ) and binge drinking episodes ( p = 0.0021 ) over the 48 month follow-up period . Women in the experimental group who became pregnant during the follow-up period had the most dramatic decreases in alcohol use . A logistic regression model based on a 20 % or greater reduction in drinking found an odds ratio of 1.93 ( confidence interval 1.07 - 3.46 ) in the sample exposed to physician intervention . Age , smoking , depression , conduct disorder , antisocial personality disorder , and illicit drug use did not reduce drinking significantly . No significant differences were found in health care utilization and health status between groups . CONCLUSIONS This trial provides the first direct evidence that brief intervention is associated with sustained reductions in alcohol consumption by women of childbearing age . The results have enormous implication s for the U.S. health care system",
"AIM To evaluate the efficacy of a short-term alcohol-focused intervention for maritally distressed women , and to explore changes in relationship functioning . DESIGN Participants were assigned r and omly to an alcohol-focused treatment or to a waiting-list control group . The waiting-list control group began the intervention at 1-month follow-up . SETTING The intervention took place at a research and training centre offering outpatient psychology services to the community . PARTICIPANTS A sample of 32 women with alcohol and marital problems were recruited through the media . Participants reported protracted alcohol problems , moderate to severe impact of alcohol on social and occupational functioning , and moderate to severe marital distress . MEASUREMENTS Measures of average alcohol consumption , marital distress , relational efficacy and depression were administered at pre- and post-therapy , and at 1 , 6 and 12-month follow-up . INTERVENTION The intervention involved six 1-hour sessions , consisting of clinical assessment , motivational interviewing , cognitive-behavioural strategies and relapse prevention . RESULTS At 1-month follow-up , the intervention was associated with statistically significant improvements in alcohol consumption , marital satisfaction , relational efficacy and depression , and these effects were sustained at 12-month follow-up . CONCLUSIONS At 1-month follow-up the intervention was associated with decreased alcohol consumption and depression , and increased marital satisfaction and relational efficacy , with evidence of maintained effects at 12-month follow-up . However , it is unlikely that reduced problem drinking and improved confidence in resolving problems were the only factors producing low marital quality in these couples . Further research is needed to identify those individuals who might benefit from marital interventions",
"Twelve-step theory hypothesizes that changes in specific cognitions and behaviors , including adoption of disease model beliefs and involvement in self-help programs , lead to symptom reduction . We examined the role of self-help affiliation in treatment outcome using causal chain analysis . Baseline , end-treatment and follow-up self-help affiliation and substance use were assessed in 252 drug and alcohol abusers attending a community program . Participants were r and omly assigned to one of three cognitive-behavioral or 12-Step oriented individual counseling conditions . Participants also were assigned , based on problem severity , to one of three treatment setting s ( partial hospitalization ; intensive outpatient ; st and ard outpatient ) that varied according to intensity of additional 12-Step programming . Repeated- measures ANOVA indicated that self-help affiliation increased overall during treatment , particularly in the 12-Step counseling condition ( versus cognitive-behavioral ) , and the partial hospitalization setting ( versus st and ard outpatient ) . Multiple regression indicated that self-help affiliation was negatively associated with substance use 6 months post-treatment , and that this was not moderated by condition . Self-help affiliation predicted outcome most strongly in the partial hospitalization setting and not at all in outpatient ; however , this effect was accounted for by participants ' initial problem severity : high-severity patients had poorer outcomes if they failed to increase self-help affiliation , relative to those who increased affiliation and to low-severity patients regardless of affiliation . Results indicate that , in this community-based program , self-help affiliation increased as a function of exposure to 12-Step oriented treatment programming , and significantly predicted better outcome among patients with high levels of problem severity . Implication s for future treatment process and dissemination research are discussed",
"AIMS To determine the acceptability to university students of practitioner-delivered screening and brief intervention ( SBI ) versus a novel approach-web-based SBI ( e-SBI ) . METHODS A r and om sample of 1910 university students was invited to indicate their preferences for various brief intervention approaches in an internet survey . RESULTS e-SBI was the most popular intervention . It was favoured by 81 % of all students and 82 % of hazardous drinkers . CONCLUSIONS e-SBI is a promising approach for the reduction of hazardous drinking among young people",
"OBJECTIVE To assess the impact of a brief training program on primary care providers ' skills , attitudes , and knowledge regarding high-risk and problem drinking . DESIGN Training plus pretesting and posttesting for program efficacy . SETTING Ambulatory primary care clinic ; academic medical center . PARTICIPANTS Fourteen attending physicians , 12 residents , and 5 nurse practitioners were r and omized by clinical team affiliation to a Special Intervention or usual care condition of a larger study . We report the results of the training program for the Special Intervention providers . INTERVENTION Providers received a 2-hour group training session plus a 10- to 20-minute individual tutorial session 2 to 6 weeks after the group session . The training focused on teaching providers how to perform patient-centered counseling for high-risk and problem drinkers . MAIN OUTCOME MEASURES Alcohol counseling skills ; attitudes regarding preparedness to intervene and perceived importance and usefulness of intervening with high-risk and problem drinkers ; and knowledge of the nature , prevalence , and appropriate treatment of alcohol abuse in primary care population s. RESULTS After training , providers scored significantly higher on measures of counseling skills , preparedness to intervene , perceived usefulness and importance of intervening , and knowledge . CONCLUSION A group training program plus brief individual feedback can significantly improve primary care providers ' counseling skills , attitudes , and knowledge regarding high-risk and problem drinkers",
"AIMS To examine the long-term impact of brief and early interventions for hazardous and harmful alcohol consumption . DESIGN A 9-month and 10-year follow-up of subjects recruited into a r and omized controlled trial of a range of alcohol-related brief interventions . SETTING General practice s , the outpatient or acute care services of a major city hospital , and a privately run health screening programmeme . PARTICIPANTS The cohort of 554 ( non-dependent ) hazardous and harmful drinkers recruited into the Australian arm of the Phase II World Health Organization collaborative project on identification and treatment of persons with harmful alcohol consumption . INTERVENTION The effectiveness of three forms of intervention , ranging from 5 to 60 minutes in duration , were compared with a no-treatment control condition . MEASUREMENTS Included drinking behaviour and biological markers of alcohol use . In addition , at 10 years subjects were asked about symptoms of diagnosable alcohol use disorders and their experience of alcohol-related psychological , social and physical harm . Mortality was also assessed . FINDINGS Results provide further evidence for the short-term effectiveness of alcohol-related brief interventions . In comparison to controls , subjects offered intervention : ( 1 ) report significantly lower consumption ; and ( 2 ) less unsafe drinking at 9-month follow-up . The intensity of intervention was not related to the amount of change in drinking behaviour . Analysis at 10 years failed to find any differences in outcomes between intervention and control groups in median consumption , mean reduction in consumption from baseline to follow-up , mortality and ICD-10 diagnoses of alcohol dependence or harmful alcohol use . CONCLUSIONS This study failed to find evidence that brief advice and counselling without regular follow-up and reinforcement can sustain significant long-term reductions in drinking behaviour at 10-year follow-up",
"BACKGROUND : The objective of this study was to determine the effects of a brief primary care provider-delivered counseling intervention on the reduction of alcohol consumption by high-risk drinkers . The intervention was implemented as part of routine primary care medical practice . METHODS : We performed a controlled clinical trial with 6- and 12-month follow-up . Three primary care practice s affiliated with an academic medical center were r and omly assigned to special intervention ( SI ) or usual care ( UC ) . A total of 9,772 primary care patients were screened for high-risk drinking . A fourth site was added later . From the group that was screened , 530 high-risk drinkers entered into the study , with 447 providing follow-up at 12 months . The intervention consisted of brief ( 5–10 minute ) patient-centered counseling plus an office system that cued providers to intervene and provided patient educational material s. RESULTS : At 12-month follow-up , after controlling for baseline differences in alcohol consumption , SI participants had significantly larger changes ( P=.03 ) in weekly alcohol intake compared to UC ( SI=−5.7 drinks per week ; UC=−3.1 drinks per week ) , and of those who changed to safe drinking at 6 months more SI participants maintained that change at 12 months than UC . CONCLUSIONS : Project Health provides evidence that screening and very brief ( 5–10 minute ) advice and counseling delivered by a patient ’s personal physician or nurse practitioner as a routine part of a primary care visit can reduce alcohol consumption by high-risk drinkers",
"Problem drinkers ( 99 males , 41 females ) wishing to quit or cut down without professional help received a 60-minute session during which they were assessed and given at r and om one of these material s : Guidelines , a two-page pamphlet outlining specific methods for achieving abstinence or moderate drinking ; Manual , a 30-page booklet describing the methods in the Guidelines ; or General Information , a package about alcohol effects . At 12 months follow-up , subjects in the Guidelines and Manual conditions showed significantly greater reductions of heavy days ( of 5 + drinks ) than subjects in General Information ( 70 % vs. 24 % ) ; in addition , significantly fewer subjects in the Guidelines and the Manual conditions expressed need for professional assistance with their drinking ( 25 % vs. 46 % in General Information ) . No main effect of condition or gender was observed on rates of moderate drinkers . At 12 months follow-up , 31 % of the men and 43 % of the women were rated as moderate drinkers . It was concluded that drinkers intending to cut down on their own derive greater benefit ( in terms of their alcohol use ) from material s containing specific instructions to develop moderate drinking than from those providing general information on alcohol effects . Clinical and research implication s of the findings are discussed",
"Thirty-one self-referred problem drinkers were r and omly assigned to one of two modalities for behavioral self-control training with a goal of moderation : ( 1 ) minimal therapist contact , in which clients worked only with a self-help manual ; and ( 2 ) therapist directed training , in which clients received self-help material s plus 10 individual treatment sessions . Both groups showed significant reductions in alcohol consumption and peak blood alcohol concentration . Contrary to expectations , there were no significant differences on outcome measures between groups . Results are interpreted within a self-control framework",
"In a continuing screening and intervention programme in Malmó , elevated serum-gamma-glutamyltransferase ( GGT ) values were used for selection of heavy drinkers . The study population consisted of 585 individuals born 1926 - 1933 with two consecutive GGT values in the upper decile of the GGT distribution , r and omly allocated either to an intervention group of to a control group . The subjects in the intervention group were further investigated and 75 % of them were judged to have elevated GGT values caused by alcohol consumption . These individuals were repeatedly encouraged to lower their overall alcohol consumption and GGT measurements were used as biofeedback method in the treatment program . The controls were informed by letter to be restrictive with their alcohol consumption and that they should receive new invitations for measurements of their liver enzymes after 2 , 4 , and 6 years . The intervention and control groups were well matched and followed over a 2 - 6-year period . Two and 4 years after the screening investigation , the GGT values in both groups were significantly decreased . There were differences , however , between the two groups with regard to sick absenteeism , hospitalization , and mortality . A significant reduction was found in sick absence during 4 years by 80 % , in hospital days during 5 years by 60 % , and in mortality during 6 years by 50 % in the intervention group compared with the control group . Thus , the intervention program was effective in preventing medico-social consequences of heavy drinking",
"This r and omized controlled trial evaluated the efficacy of a brief intervention design ed to reduce the harmful consequences of heavy drinking among high-risk college students . Students screened for risk while in their senior year of high school ( 188 women and 160 men ) were r and omly assigned to receive an individualized motivational brief intervention in their freshman year of college or to a no-treatment control condition . A normative group selected from the entire screening pool provided a natural history comparison . Follow-up assessment s over a 2-year period showed significant reductions in both drinking rates and harmful consequences , favoring students receiving the intervention . Although high-risk students continued to experience more alcohol problems than the natural history comparison group over the 2-year period , most showed a decline in problems over time , suggesting a developmental maturational effect",
"AIM To test whether a single session of motivational interviewing ( discussing alcohol , tobacco and illicit drug use ) would lead successfully to reduction in use of these drugs or in perceptions of drug-related risk and harm among young people . DESIGN Cluster r and omized trial , allocating 200 young people in the natural groups in which they were recruited to either motivational interviewing ( n=105 ) or non-intervention education-as-usual control condition ( n=95 ) . SETTING Ten further education colleges across inner London . PARTICIPANTS Two hundred young people ( age range 16 - 20 years ) currently using illegal drugs , with whom contact was established through peers trained for the project . INTERVENTION The intervention was adapted from the literature on motivational interviewing in the form of a 1-hour single-session face-to-face interview structured by a series of topics . MEASUREMENTS Changes in self-reported cigarette , alcohol , cannabis and other drug use and in a range of drug-specific perceptions and other indicators of risk and harm . Measurement at recruitment and follow-up interview 3 months later . FINDINGS A good follow-up rate ( 89.5 % ; 179 of 200 ) was achieved . In comparison to the control group , those r and omized to motivational interviewing reduced their of use of cigarettes , alcohol and cannabis , mainly through moderation of ongoing drug use rather than cessation . Effect sizes were 0.37 ( 0.15 - 0.6 ) , 0.34 ( 0.09 - 0.59 ) and 0.75 ( 0.45 - 1.0 ) for reductions in the use of cigarettes , alcohol and cannabis , respectively . For both alcohol and cannabis , the effect was greater among heavier users of these drugs and among heavier cigarette smokers . The reduced cannabis use effect was also greater among youth usually considered vulnerable or high-risk according to other criteria . Change was also evident in various indicators of risk and harm , but not as widely as the changes in drug consumption . CONCLUSIONS This study provides the first substantial evidence of non-treatment benefit to be derived among young people involved in illegal drug use in receipt of motivational interviewing . The targeting of multiple drug use in a generic fashion among young people has also been supported",
"This study reports 3-year outcomes for clients who had been treated in the five outpatient sites of Project MATCH , a multisite clinical trial design ed to test a priori client treatment matching hypotheses . The main purpose of this study was to characterize the status of the matching hypotheses at the 3-year follow-up . This entailed investigating which matching findings were sustained or even strengthened across the 3-year study period , and whether any hypotheses that were not supported earlier eventually emerged at 3 years , or conversely , whether matching findings discerned earlier dissipated at this later time . This research also examines the prognostic effects of the client matching attributes , characterizes the overall outcomes at 37 to 39 months , and explores differential effects of the three treatments at extended follow-up . With regard to the matching effects , client anger demonstrated the most consistent interaction in the trial , with significant matching effects evident at both the 1-year and 3-year follow-ups . As predicted , clients high in anger fared better in Motivational Enhancement Therapy ( MET ) than in the other two MATCH treatments : Cognitive-Behavioral Therapy ( CBT ) and Twelve-Step Facilitation ( TSF ) . Among subjects in the highest third of the anger variable , clients treated in MET had on average 76.4 % abstinent days , whereas their counterparts in the other two treatments ( CBT and TSF ) had on average 66 % abstinent days . Conversely , clients low in anger performed better after treatment in CBT and TSF than in MET . Significant matching effects for the support for drinking variable emerged in the 3-year outcome analysis , such that clients whose social networks were more supportive of drinking derived greater benefit from TSF treatment than from MET . Among subjects in the highest third of the support for drinking variable , TSF participants were abstinent 16.1 % more days than MET participants . At the lower end of this variable , difference in percent days abstinent between MET and TSF was 3 % , with MET clients having more abstinent days . A significant matching effect for psychiatric severity that appeared in the first year posttreatment was not observed after 3 years . Of the 21 client attributes used in testing the matching hypotheses , 11 had prognostic value at 3 years . Among these , readiness-to-change and self-efficacy emerged as the strongest predictors of long-term drinking outcome . With regard to the overall outcomes , the reductions in drinking that were observed in the first year after treatment were sustained over the 3-year follow-up period : almost 30 % of the subjects were totally abstinent in months 37 to 39 , whereas those who did report drinking nevertheless remained abstinent an average of two-thirds of the time . As in the 1-year follow-up , there were few differences among the three treatments , although TSF continued to show a possible slight advantage",
"BACKGROUND In a health survey of more than 21,000 men and women ages 12 - 62 years , measurement of gamma-glutamyltransferase ( GGT ) and answers on five questions on alcohol consumption were used as a basis for selecting an intervention population of early-stage risk drinkers . Altogether 290 men and 48 women met the criteria for inclusion . METHODS The 338 subjects were r and omized to a control group and two intervention groups . The minor intervention consisted of a single consultation during which possible reasons for the elevated GGT were discussed and a pamphlet with advice on changes in drinking habits was h and ed out . In the major intervention group the intervention was directed more specifically toward alcohol , with an extensive interview on drinking habits . In addition , the subjects in this group were offered follow-up consultations for new measurements of GGT . RESULTS All three groups were examined after 1 year with GGT determination and an interview on change in drinking habits during the past year . At follow-up , significant decreases in mean GGT ( 26.5 U/liter ) and self-reported alcohol intake ( 24.7 g/day ) were observed in the intervention groups compared with the control group . No significant differences were , however , observed between the intervention groups . CONCLUSION The study indicates that modest and simple interventions may yield important changes in drinking habits in early-stage risk drinkers",
"OBJECTIVE This study evaluated the relative efficacy of personalized drinking feedback ( PDF ) delivered with and without a motivational interview ( MI ) for college student drinkers . METHOD Heavy-drinking college students ( N = 54 ; 691 % female ) were identified from a large screening sample and r and omly assigned either to receive PDF during a single MI session or to receive PDF without an MI . Of these participants , 51 ( 94 % ) completed a 6-month follow-up assessment that included measures of alcohol consumption and alcohol-related problems . RESULTS At 6-months postintervention , participants in both groups showed significant , small to moderate reductions in alcohol consumption , but the groups did not differ . Women showed larger reductions than men . Rates of alcohol-related problems remained relatively unchanged . CONCLUSIONS The hypothesis that an MI would enhance the efficacy of PDF was not supported",
" The subjects were recruited from participants in a health examination of r and om sample s of the adult population in Stockholm county . Those aged 18 - 64 years who admitted a high alcohol consumption ( greater than 40 g 100 % ethanol/day ) among men and greater than 30 g among women ) or had an elevated value of serum-gammaglutamyltransferase ( GGT ) ( cut-off point 1.0 microkatal/l for men and 0.6 microkatal/l for women ) or had certain other indications of a high alcohol consumption were included . More severe cases , and those with an elevated GGT due to reasons other than alcohol , were excluded . The remaining subjects , 70 men and 13 women , were allocated at r and om to either an intervention or a comparison group . An elevated GGT was the main inclusion criteria . The subjects in the comparison group were advised by the general practitioner to cut their alcohol consumption , while those in the intervention group made further visits to their general practitioner , who gave general support and used an elevated GGT as an indication of the recent level of alcohol consumption at consecutive visits . There were three visits on average , so we are comparing a group receiving advice with a group receiving further minimal intervention . At the one-year follow-up there were greater , however not significant , reduction in GGT-level , in self-reported alcohol consumption and in a ' problem index ' in the minimal intervention group than in the comparison group",
"AIMS To examine the effectiveness of a brief intervention ( BI ) and cognitive behaviour therapy ( CBT ) for alcohol abuse . DESIGN A r and omized trial with clients r and omized within counsellors . SETTING Community-based drug and alcohol counselling in Australia . PARTICIPANTS Of all new clients attending counselling . 869 ( 82 % ) completed a computerized assessment at their first consultation . Four hundred and twenty-one ( 48 % ) were defined as eligible , of whom 295 ( 70 % ) consented and were allocated r and omly to an intervention . Of these , 13 3 ( 45 % ) were followed-up at 6 months post-test . INTERVENTIONS BI comprised the elements identified by the acronym FRAMES : feedback , responsibility , advice , menu , empathy , self-efficacy . Face-to-face counselling time was not to exceed 90 minutes . CBT comprised six consecutive weekly sessions : introduction : cravings and urges ; managing crises ; saying ' no ' and solving problems : emergencies and lapses : and maintenance . Total face-to-face counselling time was 270 minutes ( six 45-minute sessions ) . MEASUREMENTS Treatment outcomes are measured in terms of counsellor compliance , client satisfaction , weekly and binge consumption , alcohol-related problems , the AUDIT question naire and cost-effectiveness . FINDINGS When analysed on an intention-to-treat basis and for those followed-up . treatment outcomes between BI and CBT were not statistically significantly different at pre- or post-test , whether considered as continuous or categorical variables . BI was statistically significantly more cost-effective than CBT and there was no difference between them in clients ' reported levels of satisfaction . CONCLUSION For low-dependence alcohol abuse in community setting s , BI may be the treatment of choice",
"General practitioners have the potential to treat patients with alcohol problems effectively . Despite the medical implication s of excessive alcohol intake , it appears that general practitioners are not sufficiently aware of the drinking habits of their patients . The aim of the study was to investigate the accuracy of 56 r and omly chosen general practitioners in detecting which of their patients had a high alcohol intake . Altogether , 2081 patients were recruited in general practitioners ' waiting rooms , where they answered questions about their drinking habits . After the consultations general practitioners were asked to indicate the patients ' levels of alcohol intake . The results showed that general practitioners correctly identified only 27.5 % of patients who were classified as \" high risk \" drinkers , using Australian Medical Association criteria . They correctly identified only 45.2 % of patients who were classified as \" moderate to heavy \" drinkers , defined by them as drinkers who consume four or more st and ard drinks a day . These findings have important implication s for clinical practice since they indicate that general practitioners are failing to perform adequately in an important area of preventive medicine . This issue needs to be addressed in undergraduate and postgraduate medical education",
"INTRODUCTION The study was design ed to test a brief intervention for reducing alcohol consumption among moderate to heavy ( hazardous ) drinkers in a busy HMO primary care setting . METHODS In a r and omized controlled trial , hazardous drinkers ( n = 516 ) were identified by the AUDIT screening question naire . Intervention included brief clinician advice ( 30 seconds ) , a 15-minute motivational session by counselors , and printed material s. RESULTS At six-month follow-up , intervention subjects reported fewer total st and ard drinks in the past three months ( 176 versus 216 , P = .04 , one-tailed ) and fewer drinking days per week ( 2.8 versus 3.3 , P = .02 ) than controls , but similar drinks per drinking day ( 3.3 versus 3.5 ; P = .13 ) . At 12 months , intervention subjects again reported fewer drinking days per week ( 2.7 versus 3.1 ; P = .04 ) than controls , but similar numbers of st and ard drinks ( 157 versus 179 ; P = .13 ) and drinks per drinking day ( 3.6 versus 3.3 ; P = .20 ) . Intervention subjects were somewhat more likely than controls to report drinking within daily recommended limits ( drinking outcomes ( percent abstinent , frequency of drinking > or = 6 drinks per drinking occasion , estimated peak blood alcohol concentration ) , or use of medical care in the year following intervention . CONCLUSIONS A one-time , brief motivational intervention using minimal clinician time supplemented by trained counselors result ed in a modest reduction in frequency of alcohol consumption in a busy primary care population . Future research should focus on strengthening and maintaining intervention effects",
"This trial evaluated the clinical impact and cost-effectiveness of strategies promoting screening and brief alcohol intervention ( SBI ) by nurses in primary care . R and omisation was at the level of the practice and the interventions were : written guidelines ( controls , n=76 ) ; outreach training ( n=68 ) ; and training plus telephone-based support ( n=68 ) . After 3 months , just 39 % of controls implemented the SBI programme compared to 74 % of nurses in trained practice s and 71 % in trained and supported practice s. Controls also screened fewer patients and delivered fewer brief interventions to risk drinkers than other colleagues . However , there was a trade-off between the extent and the appropriateness of brief intervention delivery with controls displaying the least errors in overall patient management . Thus cost-effectiveness ratios ( cost per patient appropriately treated ) were similar between the three strategies . Given the potential for anxiety due to misdirected advice about alcohol-related risk , the balance of evidence favoured the use of written guidelines to promote SBI by nurses in primary care",
"Summary Forty-eight early-stage problem drinkers were recruited through a newspaper announcement and r and omly assigned to one of four outpatient treatment groups : ( 1 ) Bibliotherapy- Behavioral Self-Control Training ( BSCT ) , ( 2 ) BSCT-therapist directed , ( 3 ) Training in Coping Skills and ( 4 ) a combination of BSCT and Coping Skill Training . The weekly alcohol consumption in all groups decreased significantly from intake to 3 , 6 and 12 month follow-up . There were no significant differences among the groups . At the same time the number of life problems decreased significantly . The majority of the clients reduced their alcohol consumption during the assessment period , before treatment started . The absence of a non-treatment control group means that we can not be sure about the reasons for this early change . Theoretical implication s of these results are discussed",
"Abstract The effectiveness of 4 alternative forms of behavioral self-control training ( BSCT ) design ed to reduce alcohol consumption was evaluated . Forty-one problem drinkers were assigned to 1 of 4 treatment conditions : ( a ) bibliotherapy , in which clients were evaluated and then provided with a self-help manual ( Miller & Munoz , 1976 ) and self-monitoring cards but were not given therapy sessions , ( b ) BSCT alone , consisting of 10 individual sessions following material presented in the manual , ( c ) BSCT plus relaxation training , being identical to ( b ) except that training in progressive deep muscle relaxation was added within the 10 sessions , and ( d ) group therapy identical in content to ( c ) but offered in a group rather than in individual format . Outcome data included information from client interviews , psychometric measures , self-monitoring cards , and interviews with significant others . All data sources indicated significant and substantial reduction in alcohol consumption , particularly in “ alcoholismic ” drinking patterns . No significant differences were found among the 4 treatment groups . The cost-effectiveness of a bibliotherapy approach was supported , consistent with prior research . Overall improvement rates were 84 % and 69 % at 3- and 12-month follow-up , respectively",
"Present methods to screen for alcohol abuse are generally obtrusive and result in referral to services that deal mainly with alcoholics . These factors deter physicians from identifying alcohol abuse patients at an early stage . In the present study , 81 % of all primary care physicians of a single city evaluated ( i ) the efficiency and the acceptability of a nonobtrusive screening method for the identification of problem drinkers and ( ii ) the effectiveness of brief cognitive behavioral counseling given by a nurse in a lifestyle context . Patients ( n = 15,686 ) attending the private practice s of 42 primary -care physicians were asked four alcohol-neutral trauma questions in the reception area . Physicians asked about alcohol use and alcohol-related problems only to patients with previous trauma . Problem drinkers by defined criteria were offered an appointment with a nurse who , by r and om assignment , gave either 3-hr of cognitive behavioral counseling over 1 year or simply advised patients to reduce their alcohol intake . The screening method identified 62 - 85 % of expected number of problem drinkers in this population . Following the application of exclusion criteria , 105 problem drinkers were entered in the intervention part of the study . After 1 year , patients who received counseling showed significant reductions in reported alcohol consumption ( -70 % ; p psychosocial problems ( -85 % ; p serum gamma glutamyl transferase ( -32 % to -58 % ; p Physician visits were reduced ( -34 % ; p counseling . Patients receiving only advice showed neither reductions in psychosocial problems nor in serum gamma glutamyl transferase or physician visits , but reported a 46 % reduction ( p 0.01 ) in alcohol consumption . Data indicate that asking patients about recent trauma is efficient and is well accepted as the first screening instrument in the identification of the problem drinker . Cost of screening per patient is under one dollar . Counseling of 3 hr given by a nurse is markedly superior ( p < 0.05 ) to simple advice in reducing alcohol consumption , objective indicators of alcohol-related morbidity , and the frequency of physician visits",
"Summary The Marital Systems Study ( MSS ) compared the effectiveness of a short-term systems-based outpatient treatment consisting of eight sessions of Conjoint Therapy with a single session of Advice Counselling which also involved the spouse . Eligible couples were r and omly assigned to either Conjoint Therapy or Advice Counselling . In all , 218 couples were recruited for the Study . From this initial sample , 102 couples dropped out of treatment or follow-up leaving the remaining 116 couples as the Study sample . Couples in both Advice Counselling and Conjoint Therapy showed significant improvement on all marital adjustment and drinking-related outcome measures . Although significant treatment-by-time interactions were found on three of the nine variables , there were no significant differences in the change pattern between the groups on the principal drinking outcome measure , the percentage of heavy drinking days . There were also no significant between-group differences on any of the outcome measures . In essence , a single session of Advice Counselling was as effective as eight sessions of Conjoint Therapy . Couples completing the Study represented a socially stable group , with a moderate degree of alcohol-related difficulties and relatively non-distressed marital relationships . Thus , the findings pertaining to the relative effectiveness of the two treatments may be limited to this specific client population",
"OBJECTIVE Project TrEAT ( Trial for Early Alcohol Treatment ) was design ed to test the efficacy of brief physician advice in reducing alcohol use and health care utilization in problem drinkers . DESIGN R and omized controlled clinical trial with 12-month follow-up . SETTING A total of 17 community-based primary care practice s ( 64 physicians ) located in 10 Wisconsin counties . PARTICIPANTS Of the 17695 patients screened for problem drinking , 482 men and 292 women met inclusion criteria and were r and omized into a control ( n=382 ) or an experimental ( n=392 ) group . A total of 723 subjects ( 93 % ) participated in the 12-month follow-up procedures . INTERVENTION The intervention consisted of two 10- to 15-minute counseling visits delivered by physicians using a scripted workbook that included advice , education , and contracting information . MAIN OUTCOME MEASURES Alcohol use measures , emergency department visits , and hospital days . RESULTS There were no significant differences between groups at baseline on alcohol use , age , socioeconomic status , smoking status , rates of depression or anxiety , frequency of conduct disorders , lifetime drug use , or health care utilization . At the time of the 12-month follow-up , there were significant reductions in 7-day alcohol use ( mean number of drinks in previous 7 days decreased from 19.1 at baseline to 11.5 at 12 months for the experimental group vs 18.9 at baseline to 15.5 at 12 months for controls ; t=4.33 ; P episodes of binge drinking ( mean number of binge drinking episodes during previous 30 days decreased from 5.7 at baseline to 3.1 at 12 months for the experimental group vs 5.3 at baseline to 4.2 at 12 months for controls ; t=2.81 ; P frequency of excessive drinking ( percentage drinking excessively in previous 7 days decreased from 47.5 % at baseline to 17.8 % at 12 months for the experimental group vs 48.1 % at baseline to 32.5 % at 12 months for controls ; t=4.53 ; P length of hospitalization over the study period for men ( P intervention with problem drinkers decreases alcohol use and health re source utilization in the US health care system",
"OBJECTIVE The current study tested the efficacy of a brief intervention design ed to reduce drinking and drinking-related consequences among first-year fraternity members . METHOD Twelve fraternities were r and omly assigned to receive either a motivational enhancement intervention with individual and housewide feedback components ( n = 6 houses ) or a treatment-as-usual control condition ( n = 6 houses ) . Individual feedback was delivered either by peer interviewers or professional research staff . Participants were assessed during their pledge ( first ) year of house membership and during a follow-up period 1 year later . RESULTS Of the participants who completed follow-up ( N = 120 ) , fraternity members who received the brief intervention reported significant reductions in alcohol use ( total average consumption ) and typical peak blood alcohol concentrations when compared with fraternity members in the control condition . No differences in drinking-related consequences were observed . Fraternity members who received their individualized feedback from peer interviewers and professional members of the research staff reported similar outcomes . CONCLUSIONS Results provide support for the efficacy of a brief motivational enhancement intervention in reducing drinking within this high-risk population . The cost-effective use of peer interviewers appears to be a promising strategy for delivering individualized prevention programming in college population ",
"In an on-going population study in Malmö , serum-gamma-glutamyltransferase ( GGT ) is utilized both in biochemical screening of high alcohol consumption and as a tool in further investigation , treatment and control of middle-aged men with screening GGT in the top decile of the distribution . For this purpose , a special outpatient clinic has been instituted and is described in the present report . The composition of the intervention group and the feasibility of the program are reported for the first 6760 middle-aged male screening participants . A r and om one-half of the individuals with screening GGT in the top decile were allocated to the intervention group , which after primary dropouts and exclusion of concurrent diseases consisted of 252 individuals who have now been followed between three to six years . On the basis of structured interviews , hazardous levels of alcohol consumption were concluded to be present in 76 % of the group . Although one-quarter of the group dropped out of the intervention program , the results indicate that it is feasible to institute an outpatient clinic for individuals with increased GGT levels found in a general health screening examination , to retain most individuals in this outpatient clinic and to consider alcohol habits and consumption levels in relation to the laboratory test value and general physical health status",
"The study examined the effectiveness of routine intervention in alcohol abuse by a general practitioner , with help of a laboratory test . Patients diagnosed as abusers because of high erythrocyte mean cell volume value ( MCV ) and having no other cause for it were r and omly allocated to two groups : 1 ) an intervention group , comprising 92 patients ( 69 men and 23 women ) , who were invited for follow-up at three-monthly intervals for a year ; 2 ) a control ( mini-intervention ) group , 86 patients ( 71 men and 15 women ) , who were followed-up only after 12 months . Follow-up attendance was poor , particularly in the intervention group . In general , MCV-values were unchanged in the groups at the end of the study , though there was a clear trend for the female controls to have lower values ( 101.9 fl at the start , 98.5 fl at the end , p = 0.06 ) . Altogether 11 % ( 4/38 ) of the women and 7 % ( 10/140 ) of the men had clearly reduced their alcohol consumption after one year , and this was also seen in their MCV-values . Mini-intervention , especially in women with an abnormal laboratory value , seems to be , with the help of MCV , at least as effective a way of counselling nonalcoholic abusers as a more systematic intervention",
"BACKGROUND Alcohol as a cause of death in middle-aged patients is well-known from clinical studies . A similarly important correlation in the general population of urban middle-aged men is highly underestimated . Health screening investigations have shown that mortality related to alcohol is five times more common in non participants than in participants . From the mid-70s , the Malmoe Screening and Intervention Study ( MSIS ) commenced screening investigations including a large number of residents of Malmoe . One goal was to find intervention programs for individuals in an early development of problem drinking , thereby preventing development of serious complications of endstage alcoholism . Herein , we report on the mortality of heavy drinkers ( drinking more than 40 g alcohol/day ) who were r and omized to an intervention or control procedure and whose median survival was 13 years postentry into the MSIS . METHODS Health-screened men , aged 45 - 49 years at the initial screening examination and displaying serum gamma-glutamyltransferase ( GT ) in the top decentile of the GT distribution , were included . A total of 978 out of 11,257 participants met this criteria . A r and omized intervention and control study was performed for four years and consisted of men ( n = 667 ) who were born between 1927 - 1937 and who had two consecutive high GT values within 3 weeks along with heavy alcohol consumption . Half the individuals were informed of the test results and invited for further assessment by a senior physician ( n = 365 ) . The principles for brief intervention ( DiClemente et al.,1991 ; Miller and Sanchez , 1993 ; National Institute of Alcohol Abuse and Alcoholism , 1999 ) were applied . The other half of the men ( n = 302 ) were left with the information that they had a high GT value and were followed up with laboratory checkups every 2nd year . Mortality was followed up until 1991 and information on deaths was obtained from hospital and police records , necropsy reports , and death certificates . RESULTS Long-term follow-up of mortality for 10 - 16 years ( median , 13 years ) showed that 124 of the 978 men had died ( 12.7 % ) . Autopsy was performed in 96.5 % of the cases . In 59 men ( 48 % ) , death was alcohol-related . In the intervention group ( n = 365 ) , 38 ( 10.4 % ) men were dead and in the control group ( n = 302 ) , 42 ( 13.9 % ) men had died . There was a statistically significant difference ( p = 0.026 ) , with advantage for treatment . Less alcohol-related deaths and deaths occurring later during follow-up were found in the intervention group compared with the control group . The difference between the groups in total mortality , coronary heart disease , and cancer death was not statistically significant . CONCLUSIONS These findings support previous results from the MSIS study indicating that long-term intervention in urban males with alcohol-induced GT increases may be beneficial in terms of survival",
"OBJECTIVE To evaluate the effect of a nurse-conducted intervention on excessive drinkers . DESIGN R and omized , controlled trial . SETTING Vårby Health Centre , Stockholm . INTERVENTION The intervention group visited a nurse three times during a 12-month period . The controls met once with a general practitioner ( GP ) . PATIENTS Patients were recruited at a health screening on the basis of a raised gamma-glutamyl transferase ( GGT ) . Of 2338 subjects , aged 25 - 54 years , 222 had a screening GGT of > or = 0.9 mukat/l . 100 were r and omized to the treatment and 122 to the control group . MAIN OUTCOME MEASURES GGT , self-reported alcohol consumption ( g/week ) , sickness allowance and use of health care . RESULTS After 2 years a reduction of GGT from 1.52 to 1.21 mukat/l ( p = 0.02 ) had occurred in the treatment group . The controls increased their mean level of GGT from 1.75 to 2.16 mukat/l . Mean weekly alcohol consumption in the intervention group was reduced from 337 to 228 g/week ( p = 0.02 ) . The controls did not quantify their alcohol consumption initially , but reported a reduced weekly consumption at follow-up . CONCLUSION The intervention had an impact on GGT and self-reported consumption . The controls also reported decreased consumption possibly because their appointment with the GP functioned as a very brief intervention",
"OBJECTIVE Brief interventions for hazardous and low-dependent drinkers in the primary care setting have considerable empirical support . The purpose of this study was to ( 1 ) evaluate the effects of brief advice ( BA ) and motivational enhancement ( ME ) interventions on alcohol consumption . In addition , a hindsight matching design was used to ( 2 ) study the moderator effects of patient readiness to change ( alcohol use ) on alcohol consumption . METHOD The subjects ( N = 301 , 70 % men ) were patients 21 years of age or older who presented for treatment at one of 12 primary care clinics . After screening for eligibility and providing consent to participate in the study , the patients completed a baseline assessment and were r and omly assigned to the BA , ME or st and ard care ( SC ) interventions condition . Follow-up assessment s were completed at 1- , 3- , 6- , 9- and 12-months postbaseline assessment . RESULTS Evaluation of the first hypothesis ( n = 232 for these analyses ) showed that all participants tended to reduce their alcohol use considerably between the baseline and 12-month assessment s. In addition , evaluation of the second hypothesis showed a moderator effect of readiness to change in predicting the number of drinks at 12 months , such that the BA intervention seemed more effective for patients relatively low in readiness to change compared to those higher in readiness . Readiness to change did not seem to be related to changes in drinking of participants in the SC or ME conditions . CONCLUSIONS The results confirm that , among primary care patients , substantial changes in alcohol consumption are possible . They further suggest that matching studies of patient readiness to change their alcohol use , as well as other variables , are warranted",
"Summary Baseline data were collected on 263 general hospital patients screened as problem drinkers , who were r and omly allocated to one of two groups . In one group an attempt was made to refer patients for treatment while no action was taken for the other . Both groups were followed up at 12 and 18 months . At 12 months the referred group had improved significantly more than the control group in terms of self-reported alcohol problems , personal happiness , period since last drinking and work performance . However , these effects had diminished at 18 months , largely because of improvements in the control group after the 12-months follow-up , which appeared to function as an intervention . These results suggest that intervention following screening is of benefit , and that such a strategy could usefully be incorporated into normal hospital routine",
"This study examined whether a brief intervention to reduce hazardous alcohol consumption among primary care patients reduced use of medical care . In a parent , r and omized controlled trial , at-risk drinkers identified in HMO outpatient waiting rooms were r and omly assigned to receive usual care or brief clinician advice plus a 15-minute motivational counseling session . The current study ( n=514 ) examined the groups ' use of outpatient and inpatient medical services during two years after intervention . Although the intervention reduced alcohol consumption at six-month follow-up , intervention and control groups made similar numbers of outpatient visits ( M=17.7 vs. 18.3 , respectively;p=.47 ) , were equally likely to be hospitalized ( 21.2 % vs. 22.0%;p=.81 ) , and , among those hospitalized , had similar lengths of stay ( 4.7 vs. 6.6 days;p=.37 ) . Although brief interventions to reduce hazardous drinking may potentially reduce medical care utilization , more evidence is needed to substantiate their practicality and cost-effectiveness",
"One hundred and seven problem drinkers responding to a newspaper advertisement were r and omly assigned to groups receiving : ( 1 ) a general advice and information booklet ; ( 2 ) a behaviourally-based self-help manual ; ( 3 ) in addition to the manual , an opportunity to make progress reports to a telephone answering service ; and ( 4 ) in addition to the manual , an opportunity to make telephoned progress reports to an interviewer . Eighty-seven ( 81.3 % ) respondents were successfully followed-up and collateral information was available for 54 ( 61.1 % ) of these . Results showed a higher proportion drinking above recommended limits at six months follow-up in the control group ( 78 % ) than in the groups receiving the manual ( 53 % ) . There were no significant differences due to presence or type of telephone contact and poor use was made of the opportunity for telephone contact . Findings justify the widespread promotion of self-help material s as a means of assisting the natural recovery process among problem drinkers",
"Context Brief interventions can reduce problem drinking , but physicians infrequently use them . Contribution This r and omized trial , from an academic primary care setting , tested whether prompting physicians with positive alcohol screening results that are linked to specific management recommendations works . Prompted faculty , but not residents , tended to discuss alcohol problems and counsel patients more often than did their counterparts who were not prompted . At 6 months , however , only patients of prompted residents had reduced their drinking . Implication s Prompting physicians with positive alcohol screening results and recommendations for action may or may not be effective , depending on patient , physician , and setting characteristics . The Editors Alcohol use disorders are a leading cause of disability and are as common and costly as coronary artery disease and depression ( 1 - 6 ) . Primary care setting s are ideal for alcohol screening and intervention ( 7 ) . Valid , brief , practical screening tools exist , and brief interventions can reduce drinking and improve health when delivered to primary care patients with alcohol problems ( 8 - 11 ) . However , alcohol problems are often unrecognized and untreated in primary care setting s ( 12 - 16 ) . Barriers to screening and intervention include issues related specifically to addictions ( such as patient readiness and physician discomfort , frustration , lack of confidence or skills , or pessimism about efficacy of intervention ) and issues related to the delivery of preventive services in general ( such as cost , acceptability , priorities , and time ) ( 17 , 18 ) . Physician prompting can improve the likelihood of cancer screening , administration of immunizations , and smoking cessation interventions ( 19 - 21 ) . Screening and intervention for alcohol problems , however , involve more complex assessment and intervention . The effectiveness of providing physicians with screening results and a prompt without training is unknown . Such a systems intervention would be easier and less costly to implement than training all physicians about addressing alcohol problems . We tested the hypotheses that providing physicians with patients ' alcohol screening results and simple individualized recommendations would increase physician alcohol counseling and decrease patient drinking . Methods Study Description The study was a cluster r and omized trial at the physician level because r and omization at the patient level would have risked contamination . The institutional review board of the Boston University Medical Center in Boston , Massachusetts , approved the study . Patients gave informed consent and were told that the physician may be given the results of alcohol screening questions . We obtained a Certificate of Confidentiality from the federal government . Participants Physicians were recruited , enrolled , and r and omly assigned before patients were enrolled . All faculty and resident primary care physicians in an urban academic practice ( excluding the authors ) were eligible . Physicians who had seen fewer than 80 patients in the previous 3 years or who anticipated leaving the practice within 6 months were excluded . We informed physicians that we would conduct a health screening study . We used a self-administered question naire to screen and enroll patients who spoke English or Spanish ( staff were available to assist ) ( 22 ) . This was done before a visit with one of the enrolled physicians . Eligible patients were current hazardous drinkers [ 23 ] , which was defined as having consumed alcohol in the past month and either 1 ) answered yes to one or more of the CAGE ( 24 - 26 ) alcohol screening questions ( modified to refer to the past year rather than lifetime ) [ 27 ] or 2 ) drank hazardous amounts in the past month ( 28 , 29 ) . Hazardous amounts for men and women , respectively , were defined as more than 4 st and ard drinks per occasion or 14 drinks per week and as more than 3 st and ard drinks per occasion or 7 drinks per week in the past 30 days ( 26 , 30 ) . Assessment s Before patients were enrolled , physicians completed a confidential written survey ( July 1997 ) . They were asked about their attitudes toward patients with addictions ; their professional satisfaction when caring for patients with alcohol problems ; whether they or someone they knew had an alcohol or drug problem ; and other issues related to alcohol and physicians , including the physician 's usual practice s ( 18 ) . A trained staff research er interviewed enrolled patients before and after their visits with a physician ( between February 1998 and August 1999 ) . All questions not available in Spanish ( 31 ) were translated , back-translated , and checked for accuracy . The assessment visit that occurred before the physician visit addressed demographic characteristics , previous counseling for alcohol problems , and readiness to change ( 32 , 33 ) . Patients were also asked about medication use , medical comorbidity ( 34 , 35 ) , psychiatric comorbidity ( 36 , 37 ) , and tobacco and other drug use . Immediately after the physician visit , patients were interviewed to determine whether counseling had occurred , drinking amounts ( 38 , 39 ) , the quality of communication with the physician ( 40 ) , alcohol dependence symptoms ( 41 ) , and alcohol problems ( Short Inventory of Problems [ SIP-2R ] ) ( 42 ) . Six months later , patients were interviewed by telephone to determine alcohol consumption in the past 30 days ; the vali date d Timeline Followback method was used ( 43 ) . Patients and staff research ers were not blinded to group assignment ( in addition , patients were not necessarily given this information ) ; at follow-up , interviews were done without knowledge of group assignment . R and omization and Intervention Physicians were stratified by level of training ( resident or faculty ) and were r and omly assigned to the intervention or control group at the start of the study . The computer-generated r and omization was done by off-site data management personnel who had no patient or physician contact . The staff research er attached the intervention , a sheet of paper , to the encounter record the physician routinely received immediately before each patient visit . One side of the paper provided the patient 's alcohol screening results , a preliminary assessment , and specific recommendations . The screening results included answers to each of the CAGE questions , reports of usual weekly and per occasion maximum drinking amounts , and the patient 's report of readiness to change on a 10-point scale ( 44 ) ( see Appendix Figure ) . For patients reporting hazardous drinking amounts but no affirmative CAGE question naire responses , the assessment was drinking hazardous amounts and the recommendation was consider advising safe drinking limits and consider providing patients with a pamphlet provided by the study titled How to Cut Down on Your Drinking ( 27 ) . For patients reporting any affirmative CAGE responses but no hazardous drinking amounts , the assessment was possible alcohol problems and recommendations were consider advising abstinence , provide the pamphlet , and referral to addiction treatment . For patients reporting affirmative CAGE question naire responses and hazardous drinking amounts , the assessment was both possible alcohol problems and drinking hazardous amounts and recommendations were consider advising abstinence and referral to addiction treatment . The other side of the paper provided the predictive value of CAGE based on the prevalence of alcohol abuse or dependence in the practice ( 26 , 31 ) , definitions of hazardous drinking , an approach for patients who are not ready to change , a list of abuse or dependence symptoms , and referral information . To increase counseling rates ( not for data collection ) , we attached a Post-it note to the encounter form asking physicians to indicate whether alcohol was discussed and , if not , why ( 45 ) . Physicians in the control group did not receive any information from the study . Statistical Analysis All analyses were performed by using SAS software , version 8.1 [ SAS Institute , Inc. , Cary , North Carolina ] . The primary prespecified outcomes of the study were the occurrence of physician discussion s regarding alcohol problems during the physicianpatient encounter and a decrease in patient drinking . Patients were asked whether they had 1 ) received alcohol counseling , defined as advice on safe drinking limits , advice to cut down or abstain , or referral to an alcohol specialist or treatment program ; 2 ) received any advice [ including counseling ] ; or 3 ) participated in any discussion about alcohol ( including advice ) . An example question was : Did the doctor give you any advice about your drinking habits ? Drinks per drinking day was the primary drinking outcome . We examined additional measures in secondary analyses : days drinking ( any day on which a drink was taken ) , days binge drinking ( any day on which per occasion amounts noted previously were exceeded ) , proportion drinking hazardous amounts , proportion binge drinking , and proportion abstinent . We compared sociodemographic characteristics , level of training , and mean number of patients enrolled for physicians in the intervention and control groups by using the two independent sample s t-test and the Fisher exact test , as applicable . We then compared patients who were seen by physicians in the intervention and control groups with respect to measured characteristics . We compared patients who were available and unavailable at the 6-month follow-up by r and omized group , physician level of training , and sociodemographic characteristics . Outcomes were compared between physicians in the intervention and control groups by using an intention-to-treat analysis ( physicians were analyzed in the groups to which they were r and omly assigned ) . Generalized estimating equations ( GEE ) were used to adjust for clustering of patients by physician ( PROC GENMOD , SAS software , version 8.1 ) ( 46 ) . For continuous outcomes , we specified the identity link function ; for dichotomous outcomes , we specified the logit link",
"OBJECTIVE This study examines the risk , predictors of relapse and the effects of successfully sustained remission on the drinking behavior , functioning , life context , coping and help seeking of older adults who were problem drinkers earlier in life . METHOD Older former problem drinkers ( n = 447 ) were prospect ively followed for 10 years and compared to lifetime nonproblem drinkers . RESULTS Of former problem drinkers , 31 % ( n = 141 ) died over the 10-year interval , a rate 1.6 times higher than that of lifetime nonproblem drinkers . Among surviving former problem drinkers , although relapse was relatively uncommon ( 11 % ) , a less severe drinking history , heavier baseline alcohol consumption , and lower baseline income were associated with relapse . The majority ( 63 % ) of former problem drinkers who successfully achieved sustained remission continued to drink alcohol , though at levels below those consumed by older lifetime nonproblem drinkers ( n = 339 ) . Stably remitted problem drinkers who were abstinent ( SRAs ) generally reported more severe drinking histories , greater functioning and life context deficits and more help seeking than did stably remitted problem drinkers who were nonabstinent ( SRNs ) . Although SRAs and SRNs both experienced improvements in functioning over the 10-year interval , they continued to experience financial , health-related and life context deficits relative to older lifetime nonproblem drinkers . CONCLUSIONS Results suggest there are long-term costs associated with earlier drinking problems , even when remission is maintained . Both current drinking behavior and drinking history are worth considering when making recommendations regarding older adults ' alcohol consumption",
" From a population of 2,114 patients attending somatic outpatient clinics , 78 patients were selected who had either an excessive consumption of alcohol according to question naires or a raised gamma glutamyltransferase ( GGT ) value ( above 0.6 mu kat/l ) due to alcohol . They had not undergone treatment for problem drinking previously , and had no serious alcohol dependence . They were thereby classified as excessive consumers of alcohol , and r and omly allocated to an intervention ( n = 36 ) or to a control group ( n = 42 ) . Those in the intervention group were followed up by a nurse once a month and by a doctor every third month for a total of 12 months . Laboratory tests were taken monthly . Consumption of alcohol , GGT and triglyceride levels , and sickness allowance days were decreased in the intervention group compared to the time before intervention . In contrast , the number of sickness allowance days in the control group increased . There was also a tendency towards a positive effect of intervention on the number of consultations made with a statistically not significant decrease of consultations after intervention . The study thus indicates that an early and relatively simple intervention programme for problem drinkers may be effective and can be carried out at a low cost and with a positive response from the patients",
"A self-help book was offered to persons wanting to quit or cut down on their alcohol use . Study participants ( 99 men , 56 women ) were recruited through advertisements , screened by telephone , and r and omly assigned to 1 of 2 conditions . Book by mail or Assessment + Book ( 30-min telephone motivational interview plus book by mail ) . At 3-month follow-up , significantly more participants qualified as moderate drinkers in the Assessment + Book condition ( 65 % vs. 43 % ) , by this criterion : effect of condition , but significantly more women than men were rated as moderate drinkers ( 71 % vs. 52 % ) . Collateral informants corroborated the participants ' reports of drinking",
"BACKGROUND There is a need for primary care providers to have brief effective methods to intervene with high-risk drinkers during a regular outpatient visit . OBJECTIVE To determine whether brief physician- and nurse practitioner-delivered counseling intervention is efficacious as part of routine primary care in reducing alcohol consumption by high-risk drinkers . METHODS Academic medical center-affiliated primary care practice sites were r and omized to special intervention or to usual care . From a screened population of 9772 patients seeking routine medical care with their primary care providers , 530 high-risk drinkers were entered into the study . Special intervention included training providers in a brief ( 5- to 10-minute ) patient-centered counseling intervention , and an office support system that screened patients , cued providers to intervene , and made patient education material s available . The primary outcome measures were change in alcohol use from baseline to 6 months as measured by weekly alcohol consumption and frequency of binge drinking episodes . RESULTS Participants in the special intervention and usual care groups were similar on important background variables and potential confounders except that special intervention participants had significantly higher baseline levels of alcohol usage ( P = .01 ) . At 6-month follow-up , in the 91 % of the cohort who provided follow-up information , alcohol consumption was significantly reduced when adjusted for age , sex , and baseline alcohol usage ( special intervention , -5.8 drinks per week ; usual care , -3.4 drinks per week ; P = .001 ) . CONCLUSIONS This study provides evidence that screening and very brief ( 5- to 10-minute ) advice and counseling delivered by a physician or nurse practitioner as part of routine primary care significantly reduces alcohol consumption by high-risk drinkers"
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411803c4-06ff-11f0-808a-c43d1ab1c353
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The metric of disability-adjusted life years ( DALYs ) has become the global st and ard of measuring burden of disease . DALYs are comprised of years of life lost due to premature mortality and years of healthy life lost due to living with disability . In order to calculate the second part of the DALY equation , disease specific disability weights have to be established , i.e. measures for the decline of health associated with these disease states , which vary between zero for perfect health and one for death . Although these disability weights are key for estimating DALYs , there have not been many comprehensive studies with empirical determinations of them . This article describes a systematic review on the state of the art with respect to empirically determining disability weights . Based on this review , a multi- method approach is outlined , which has also been implemented in a US study to measure burden of disease . This approach involves the use of psychometric methodology as well as economic trade-off methods for determining the value of health states . It is conceptualized as a disaggregated approach , where the disability weight of any health state can be calculated if the attributes of this health state are known . The US study received the collaboration of experts from more than 20 institutes of the National Institutes of Health and of the Centers for Disease Control and Prevention . First results will be available by the end of this year
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[
"Background Person trade-off ( PTO ) elicitations yield different values than st and ard utility measures , such as time trade-off ( TTO ) elicitations . Some people believe this difference arises because the PTO captures the importance of distributive principles other than maximizing treatment benefits . We conducted a qualitative study to determine whether people mention considerations related to distributive principles other than QALY-maximization more often in PTO elicitations than in TTO elicitations and whether this could account for the empirical differences . Methods 64 members of the general public were r and omized to one of three different face-to-face interviews , thinking aloud as they responded to TTO and PTO elicitations . Participants responded to a TTO followed by a PTO elicitation within context s that compared either : 1 ) two life-saving treatments ; 2 ) two cure treatments ; or 3 ) a life-saving treatment versus a cure treatment . Results When people were asked to choose between life-saving treatments , non-maximizing principles were more common with the PTO than the TTO task . Only 5 % of participants considered non-maximizing principles as they responded to the TTO elicitation compared to 68 % of participants who did so when responding to the PTO elicitation . Non-maximizing principles that emerged included importance of e quality of life and a desire to avoid discrimination . However , these principles were less common in the other two context s. Regardless of context , though , participants were significantly more likely to respond from a societal perspective with the PTO compared to the TTO elicitation . Conclusion When lives are at stake , within the context of a PTO elicitation , people are more likely to consider non-maximizing principles , including the importance of equal access to a life-saving treatment , avoiding prejudice or discrimination , and in rare cases giving treatment priority based purely on the position of being worse-off",
"Background In survey studies on health-state valuations , ordinal ranking exercises often are used as precursors to other elicitation methods such as the time trade-off ( TTO ) or st and ard gamble , but the ranking data have not been used in deriving cardinal valuations . This study reconsiders the role of ordinal ranks in valuing health and introduces a new approach to estimate interval-scaled valuations based on aggregate ranking data . Methods Analyses were undertaken on data from a previously published general population survey study in the United Kingdom that included rankings and TTO values for hypothetical states described using the EQ-5D classification system . The EQ-5D includes five domains ( mobility , self-care , usual activities , pain/discomfort and anxiety/depression ) with three possible levels on each . Rank data were analysed using a r and om utility model , operationalized through conditional logit regression . In the statistical model , probabilities of observed rankings were related to the latent utilities of different health states , modeled as a linear function of EQ-5D domain scores , as in previously reported EQ-5D valuation functions . Predicted valuations based on the conditional logit model were compared to observed TTO values for the 42 states in the study and to predictions based on a model estimated directly from the TTO values . Models were evaluated using the intraclass correlation coefficient ( ICC ) between predictions and mean observations , and the root mean squared error of predictions at the individual level . Results Agreement between predicted valuations from the rank model and observed TTO values was very high , with an ICC of 0.97 , only marginally lower than for predictions based on the model estimated directly from TTO values ( ICC = 0.99 ) . Individual-level errors were also comparable in the two models , with root mean squared errors of 0.503 and 0.496 for the rank-based and TTO-based predictions , respectively . Conclusions Modeling health-state valuations based on ordinal ranks can provide results that are similar to those obtained from more widely analyzed valuation techniques such as the TTO . The information content in aggregate ranking data is not currently exploited to full advantage . The possibility of estimating cardinal valuations from ordinal ranks could also simplify future data collection dramatically and facilitate wider empirical study of health-state valuations in diverse setting s and population groups",
"Objective . Elicited preferences for health states vary among scaling methods , manners of describing health states , and other features of the elicitation process . The authors examined the effects of changing the search procedure for a subject 's utility on mean utility values . Methods . A r and omized controlled trial of two search procedures ( titration and \" ping-pong \" ) using two otherwise identical computer programs that describe health states related to Gaucher 's disease , then measuring subjects ' preferences . Setting . Paid , healthy volunteers recruited from the community through advertisements . Re sults . The mean time tradeoff ( TTO ) and st and ard gamble ( SG ) utility values for life with severe anemia and splenomegaly and life with chronic bone pain from Gaucher 's disease were between 0.10 and 0.15 higher with the titration search procedure than with the ping-pong procedure . Effects of the search procedure were additive with var iability due to scaling methods , result ing in mean differences in utility ratings for the same health state of as much as 0.28 among procedures and scaling methods . Effects of search procedures on utility values persisted on repeated testing at week 2 and week 3 ; there was no evidence of convergence to a single \" true \" utility value over time . Conclusions . The procedure used to search for subjects ' utility values strongly influences the results of preference- assessment experiments . Effects of search pro cedures persist on repeated testing . The results suggest that utility values are heavily influenced by , if not created during , the process of elicitation . Thus , utility values elic ited using different search procedures may not be directly comparable . Key words : search procedures ; utility elicitations ; patient preferences ; titration ; ping-pong . ( Med Decis Making 1998;18:76 - 83",
"Purpose . Traditional decision-analytic models presume that utilities are invariant to context . The influence of 2 types of context on patients ' utility assessment s was examined here the path by which one reaches a health state and personal experience with a health state . Methods . Three groups of patients were interviewed : men older than age 49 years with prostate cancer but no diabetes ( CaP ) , diabetes but no prostate cancer ( DM ) , and neither disease ( ND ) . The utility of erectile dysfunction ( ED ) was assessed using a st and ard gamble ( SG ) . Each subject completed 2 SGs : 1 ) a no- context version that gave no explanation for the cause of ED and 2 ) a context ualized version in which prostate cancer treatment , the failure to manage diabetes , or the natural course of aging was said to be the cause . Results . Patients with disease assigned higher utilities to ED in a matching context than in discrepant context s. Regression models found that the valuation process was also sensitive to the match between disease path in the utility assessment and patients ' personal experiences . Conclusions . These findings lend insight into why a context ual utility assessment s typically used in decision analyses have not been able to predict patient behavior as well as expected . The valuation process appears to change systematic ally when context is specified , suggesting that unspecified context s rather than r and om error may lead to fluctuations in the values assigned to identical health states",
"OBJECTIVES To compare the Quality -Adjusted Life Year ( QALY ) values produced from a direct health profile QALY calculation method , using patient values , with those derived from a conventional QALY calculation method , using general population values . METHODS Comparison of QALY values generated from patient valuations of health profiles , using a chained version of the Time Trade-Off method , with QALY values derived from a conventional QALY calculation method , using general population values of EQ-5D states , an observational survey of MS patients , and a r and omized controlled trial . RESULTS Using patient valuations of health profiles , QALY values of treatment and placebo were 2.610 and 2.568 , respectively , generating a gain of 0.042 . The conventional QALY method gave values of 2.042 versus 1.998 , producing a gain of 0.044 . These findings were generally robust under sensitivity analyses . CONCLUSIONS QALY values were dependent on the calculation method used , but QALY gains were similar between methods . QALY values from the conventional QALY calculation method appeared robust to most changes in the assumptions used to derive values . The direct health profile QALY method was however more able to account for heterogeneity in preferences",
"Background . The Health Utilities Index Mark 3 ( HUI3 ) is a generic multiattribute preference‐based measure of health status and health‐related quality of life that is widely used as an outcome measure in clinical studies , in population health surveys , in the estimation of quality ‐adjusted life years , and in economic evaluations . HUI3 consists of eight attributes ( or dimensions ) of health status : vision , hearing , speech , ambulation , dexterity , emotion , cognition , and pain with 5 or 6 levels per attribute , varying from highly impaired to normal . Objectives . The objectives are to present a multiattribute utility function and eight single‐attribute utility functions for the HUI3 system based on community preferences . Study Design . Two preference surveys were conducted . One , the modeling survey , collected preference scores for the estimation of the utility functions . The other , the direct survey , provided independent scores to assess the predictive validity of the utility functions . Measures . Preference measures included value scores obtained on the Feeling Thermometer and st and ard gamble utility scores obtained using the Chance Board . Respondents . A r and om sample of the general population ( ≥16 years of age ) in Hamilton , Ontario , Canada . Results . Estimates were obtained for eight single‐attribute utility functions and an overall multiattribute utility function . The intraclass correlation coefficient between directly measured utility scores and scores generated by the multiattribute function for 73 health states was 0.88 . Conclusions . The HUI3 scoring function has strong theoretical and empirical foundations . It performs well in predicting directly measured scores . The HUI3 system provides a practical way to obtain utility scores based on community preferences",
"Background . Many subjects attach equal value to different health care programs in surveys eliciting preferences for re source allocation . It has been suggested that subjects may be prepared to attach different priority if they were asked to evaluate someone else ’s decision instead of adopting the role of a social decision maker . This study investigated whether the perspective individuals are asked to adopt affects their priority setting decisions and the likelihood of assigning equal value to health care programs . Methods . 1253 members of an Internet panel were presented a set of clinical vignettes describing preventive health care initiatives and were asked to prioritize among these . They choose between “ discrimination , ” that is , allocating all re sources on the better program , and “ e quality , ” that is , dividing the re sources equally between programs while reducing efficiency . Respondents were r and omized to either of 4 survey versions that differed in terms of perspective ( evaluator vs. decision maker ) and expert status ( expert vs. layperson ) of the role to be adopted . Results . Subjects in the evaluator perspectives were more likely to choose e quality over discrimination between patients as compared to those in the social decision-maker perspectives , regardless of expert status ( odds ratios 2.09 and 2.03 , P Excess rates of e quality choices in the evaluator frames result ed from passive acceptance of e quality decisions and active revision of prioritization decisions . Conclusion . Preferences for an equal allocation of re sources are strongly affected by decision-making perspective but stable across expert status of the adopted role",
"Background . The belief that small preventive efforts bring large benefits may explain why many people say they value prevention above all other types of health care . However , it often takes a great deal of preventive medicine to prevent a bad outcome . This study explores whether people value prevention or cure more when each brings the same magnitude of benefit and examines whether preferences for prevention or cure vary according to the severity of the disability of the patients who can receive the preventive or curative intervention . Methods . 289 prospect i ve jurors were presented with a policy dilemma involving how best to allocate funds to benefit people with varying levels of disability . Each project was said to influence the functional ability of 100 nursing home residents , either by improving their level of function or by preventing their level of function from declining . Results . When given a choice between preventive and curative interventions , more subjects preferred the preventive intervention ( 37 % vs 21 % , p = 0.002 ) . However , when the strength of people 's preferences was taken into account , the preference for preventive interventions was not statistically significant ( p = 0.135 ) . With both preventive and curative interventions , the subjects preferred helping patients with more severe disabilities ( p helping more severely disabled patients did not differ for prevention and cure ( p = 0.663 ) . Conclusion . When the magnitude of benefit was held constant , the subjects slightly preferred prevention over cure . In addition , they preferred directing limited re sources toward those with greater disabilities , regardless of whether those re sources were targeted toward prevention or cure . These findings suggest that previously stated preferences for prevention over cure may result from a belief that small efforts at prevention will be repaid by large reductions in the later need for cure",
"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"
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41180428-06ff-11f0-808a-c43d1ab1c353
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Background Attention-deficit/hyperactivity disorder ( ADHD ) is a complex highly comorbid disorder , which can have a huge impact on those with ADHD , their family , and the community around them . ADHD is currently managed using pharmacological and nonpharmacological interventions . However , with advances in technology and an increase in the use of mobile apps , managing ADHD can be augmented using apps specifically design ed for this population . However , little is known regarding the suitability and usability of currently available apps . Objective The aim of this study was to explore the suitability of the top 10 listed apps for children and young people with ADHD and clinicians who work with them . It is hypothesized that mobile apps design ed for this population could be more suitably design ed for this population . Methods The top 10 listed apps that are specifically targeted toward children and young people with ADHD in the United Kingdom were identified via the Google Play ( n=5 ) and iTunes store ( n=5 ) . Interviews were then undertaken with 5 clinicians who specialize in treating this population and 5 children and young people with ADHD themselves , to explore their opinions of the 10 apps identified and what they believe the key components are for apps to be suitable for this population . Results Five themes emerged from clinician and young people interviews : the accessibility of the technology , the importance of relating to apps , addressing ADHD symptoms and related difficulties , age appropriateness , and app interaction . Three additional themes emerged from the clinician interviews alone : monitoring symptoms , side effects and app effect on relationships , and the impact of common comorbid conditions . The characteristics of the apps did not appear to match well with the views of our sample . Conclusions These findings suggest that the apps may not be suitable in meeting the complex needs associated with this condition . Further research is required to explore the value of apps for children and young people with ADHD and their families and , in particular , any positive role for apps in the management of ADHD in this age group . A systematic review on how technology can be used to engage this population and how it can be used to help them would be a useful way forward . This could be the platform to begin exploring the use of apps further
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"We report a prospect i ve longitudinal study of 101 male adolescents ( ages 16 to 23 years ) who had been diagnosed hyperactive in childhood ( ages 6 to 12 years ) , compared with 100 normal controls . The DSM-III diagnoses were made blind to group membership . Information was obtained for 98 % of the original cohort . The full attention deficit disorder with hyperactivity ( ADDH ) syndrome persisted in 31 % of the prob and s vs in 3 % of the controls . The only other two conditions that distinguished the groups significantly were conduct and substance use disorders . These disorders aggregated significantly among the prob and s with continued ADDH . The results indicate that the greatest risk factor for the development of antisocial behavior and drug abuse is the maintenance of ADDH symptoms . Substance use disorders followed the onset of conduct disorder in the overwhelming majority of the cases",
"Introduction The National Institute for Health and Care Excellence ( NICE ) guidelines for attention deficit/hyperactivity disorder ( ADHD ) state that young people need to have access to the best evidence -based care to improve outcome . The current ‘ gold st and ard ’ ADHD diagnostic assessment combines clinical observation with subjective parent , teacher and self-reports . In routine practice , reports from multiple informants may be unavailable or contradictory , leading to diagnostic uncertainty and delay . The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes . This trial investigates whether providing clinicians with an objective report of levels of attention , impulsivity and activity can lead to an earlier , and more accurate , clinical diagnosis and improved patient outcome . Methods and analysis This multisite r and omised controlled trial will recruit young people ( aged 6–17 years old ) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services ( CAMHS ) and Community Paediatric clinics across Engl and . Routine clinical assessment will be augmented by the QbTest , incorporating a continuous performance test ( CPT ) and infrared motion tracking of activity . The participant will be r and omised into one of two study arms : QbOpen ( clinician has immediate access to a QbTest report ) : QbBlind ( report is withheld until the study end ) . Primary outcomes are time to diagnosis and diagnostic accuracy . Secondary outcomes include clinician 's diagnostic confidence and routine clinical outcome measures . Cost-effective analysis will be conducted , alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice . Ethics and dissemination The findings from the study will inform commissioners , clinicians and managers about the feasibility , acceptability , clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD . The results will be su bmi tted for publication in peer- review ed journals . The study has received ethical approval . Trial registration number NCT02209116",
"Objective : The main aim of this study was to examine the age-dependent remission from ADHD in girls transitioning through childhood into adolescence and early adulthood . Method : We conducted a 5-year prospect i ve follow-up study of 123 girls with ADHD and 106 non-ADHD control girls aged between 6 and 17 years at ascertainment . ADHD was considered persistent at follow-up if participants met full diagnostic criteria for DSM-IV ADHD or met residual criteria for DSM-IV ADHD with associated impairment ( Global Age Forum [ GAF ] score ADHD was persistent in 71 % ( 95 % CI = 61 - 79 % ) of girls with ADHD . Participants with persistent ADHD at follow-up had more psychiatric comorbidity , behavior problems , and functional impairment than girls with ADHD in remission . Remitted ADHD , however , continued to be associated with functional impairment relative to non-ADHD controls . Persistence at 5 years was predicted by increased behavioral impairment at baseline . Conclusion : This 5-year follow-up suggests that many girls with ADHD experience persistent symptoms and /or functional impairment through late adolescence and into early adulthood . ( J. of Att . Dis . 2011 ; 15(3 ) 183 - 192",
"OBJECTIVE : We examined long-term outcomes of attention-deficit/hyperactivity disorder ( ADHD ) in a population -based sample of childhood ADHD cases and controls , prospect ively assessed as adults . METHODS : Adults with childhood ADHD and non-ADHD controls from the same birth cohort ( N = 5718 ) were invited to participate in a prospect i ve outcome study . Vital status was determined for birth cohort members . St and ardized mortality ratios ( SMRs ) were constructed to compare overall and cause-specific mortality between childhood ADHD cases and controls . Incarceration status was determined for childhood ADHD cases . A st and ardized neuropsychiatric interview was administered . RESULTS : Vital status for 367 childhood ADHD cases was determined : 7 ( 1.9 % ) were deceased , and 10 ( 2.7 % ) were currently incarcerated . The SMR for overall survival of childhood ADHD cases versus controls was 1.88 ( 95 % confidence interval [ CI ] , 0.83–4.26 ; P = .13 ) and for accidents only was 1.70 ( 95 % CI , 0.49–5.97 ; P = .41 ) . However , the cause-specific mortality for suicide only was significantly higher among ADHD cases ( SMR , 4.83 ; 95 % CI , 1.14–20.46 ; P = .032 ) . Among the childhood ADHD cases participating in the prospect i ve assessment ( N = 232 ; mean age , 27.0 years ) , ADHD persisted into adulthood for 29.3 % ( 95 % CI , 23.5–35.2 ) . Participating childhood ADHD cases were more likely than controls ( N = 335 ; mean age , 28.6 years ) to have ≥1 other psychiatric disorder ( 56.9 % vs 34.9 % ; odds ratio , 2.6 ; 95 % CI , 1.8–3.8 ; P significant risk for mortality , persistence of ADHD , and long-term morbidity in adulthood",
"OBJECTIVE Numerous studies have examined the adolescent and young adult fate of children with attention deficit hyperactivity disorder ( ADHD ) . In marked contrast , relatively little is known about the adult outcome of these children . There have been only two controlled , prospect i ve studies of psychiatric status into adulthood . The present study was conducted to gain further underst and ing of the natural course of this common childhood condition . METHOD This was a prospect i ve follow-up of clinical ly diagnosed , white boys of average intelligence who were referred by teachers to a child psychiatric research clinic at an average age of 7.3 years . At a mean age of 24.1 years , 85 prob and s ( 82 % of the childhood cohort ) and 73 comparison subjects ( 94 % of adolescent comparison subjects ) were directly interviewed by trained clinicians who were blind to group status . RESULTS Evaluations of the prob and s and comparison subjects indicated significantly higher prevalences of antisocial personality disorder ( 12 % versus 3 % ) and nonalcohol substance abuse ( 12 % versus 4 % ) in the prob and s , whereas mood disorders ( 4 % versus 4 % ) and anxiety disorders ( 2 % versus 7 % ) were not significantly different . At adult follow-up , ADHD was rare , occurring in only 4 % of the prob and s ( no comparison subjects ) . CONCLUSIONS The results of the present study are consistent with the authors ' previously reported major findings . They strongly suggest that children with ADHD are at significantly higher risk for a specific negative course marked by antisocial and substance-related disorders",
"OBJECTIVE To evaluate the predictors of persistence and the timing of remission of attention-deficit hyperactivity disorder ( ADHD ) . METHOD Subjects were 6- to 17-year old Caucasian , non-Hispanic boys with and without ADHD . DSM-III-R structured diagnostic interviews and blind raters were used to examine psychiatric diagnoses , cognitive achievement , social , school , and family functioning at a 4-year follow-up assessment . RESULTS At the 4-year follow-up assessment , 85 % of children with ADHD continued to have the disorder and 15 % remitted . Of those who remitted , half did so in childhood and the other half in adolescence . Predictors of persistence were familiality of ADHD , psychosocial adversity , and comorbidity with conduct , mood , and anxiety disorders . CONCLUSIONS The findings prospect ively confirm that the majority of children with ADHD will continue to express the disorder 4 years later . For a minority of children , ADHD was a transient disorder that remits early in development . In addition , we have shown that persistence of ADHD is predictable . Familiality , adversity , and psychiatric comorbidity may be clinical ly useful predictors of which children with ADHD are at risk for a persistent disorder",
"BACKGROUND Our objective was to estimate the lifetime prevalence of psychopathology in a sample of youth with and without attention deficit hyperactivity disorder ( ADHD ) through young adulthood using contemporaneous diagnostic and analytic techniques . METHOD We conducted a case-control , 10-year prospect i ve study of ADHD youth . At baseline , we assessed consecutively referred male , Caucasian children with ( n=140 ) and without ( n=120 ) DSM-III-R ADHD , aged 6 - 18 years , ascertained from psychiatric and pediatric sources to allow for generalizability of results . At the 10-year follow-up , 112 ( 80 % ) and 105 ( 88 % ) of the ADHD and control children , respectively , were reassessed ( mean age 22 years ) . We created the following categories of psychiatric disorders : Major Psychopathology ( mood disorders and psychosis ) , Anxiety Disorders , Antisocial Disorders ( conduct , oppositional-defiant , and antisocial personality disorder ) , Developmental Disorders ( elimination , language , and tics disorder ) , and Substance Dependence Disorders ( alcohol , drug , and nicotine dependence ) , as measured by blinded structured diagnostic interview . RESULTS The lifetime prevalence for all categories of psychopathology were significantly greater in ADHD young adults compared to controls , with hazard ratios and 95 % confidence intervals of 6.1 ( 3.5 - 10.7 ) , 2.2 ( 1.5 - 3.2 ) , 5.9 ( 3.9 - 8.8 ) , 2.5 ( 1.7 - 3.6 ) , and 2.0 ( 1.3 - 3.0 ) , respectively , for the categories described above . CONCLUSIONS By their young adult years , ADHD youth were at high risk for a wide range of adverse psychiatric outcomes including markedly elevated rates of antisocial , addictive , mood and anxiety disorders . These prospect i ve findings provide further evidence for the high morbidity associated with ADHD across the life-cycle and stress the importance of early recognition of this disorder for prevention and intervention strategies",
"The psychiatric outcome is reported for a large sample of hyperactive children ( N = 123 ) , meeting research diagnostic criteria , and normal control children ( N = 66 ) followed prospect ively over an 8-year period into adolescence . Over 80 % of the hyperactives were attention deficit hyperactivity disorder ( ADHD ) and 60 % had either oppositional defiant disorder and /or conduct disorder at outcome . Rates of antisocial acts were considerably higher among hyperactives than normals , as were cigarette and marijuana use and negative academic outcomes . The presence of conduct disorder accounted for much though not all of these outcomes . Family status of hyperactives was much less stable over time than in the normal subjects . The use of research criteria for diagnosing children as hyperactive identifies a pattern of behavioral symptoms that is highly stable over time and associated with considerably greater risk for family disturbance and negative academic and social outcomes in adolescence than has been previously reported"
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Background The literature comparing limited incision and st and ard incision THAs is confusing regarding whether limited incision THA improves short-term recovery without compromising long-term durability and survival . Further , previously published meta-analyses can not conclude that limited incision THA is better . With new data , we seek to discover if the answers now exist . Purpose We used meta- analysis to compare surgical and hospitalization data , clinical outcomes , and complication rates , and thus ( 1 ) confirm whether limited incision THA is at least comparable to st and ard incision THA ; and ( 2 ) determine whether limited incision THA is an improvement over st and ard incision THA . Methods The PubMed data base was search ed using the terms “ minimally ” , “ invasive ” , and “ total hip ” . Inclusion was limited to studies directly comparing limited incision with st and ard incision THA and reporting effect sizes . Results We identified 418 articles . Of these 11 provided background information and 30 provided data ( 3548 THAs ) for the systematic review . Limited incision THA was better than st and ard incision THA in four measures : length of hospitalization ( 6 versus 7 days ) , VAS pain at discharge ( 2 versus 4 ) , blood loss ( 421 mL versus 494 mL ) , and the Harris hip score at 3 months postoperation ( 90 versus 84 ) . There were no outcomes for which st and ard incision was better . There was no major difference in the rate of complications . Conclusions Short-term recovery favors limited incision over st and ard incision THA . The lack of consistent reporting for surgical outcomes , clinical outcomes , and complications continues to create difficulties when comparing limited and st and ard incision THAs
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"Background For total hip arthroplasty ( THA ) , minimally invasive surgery ( MIS ) uses a smaller incision and less muscle dissection than the classic approach ( CLASS ) , and may lead to faster rehabilitation . Questions / purpose sDoes minimally invasive hip arthroplasty result in superior clinical outcomes ? Patients and Methods In this double-blind r and omized controlled trial , 120 consecutive primary noncemented THAs in 120 patients were assigned to one of two groups ( MIS or CLASS ) . The r and omization sequence was stratified for two groups of surgeons , ie , those using a posterolateral approach ( PL-CLASS or PL-MIS ) and those using an anterolateral approach ( AL-CLASS or AL-MIS ) . Length of the incisions was 18 cm for the CLASS procedures . MIS incisions were extended at the skin level to 18 cm at the end of the procedure . The primary end point was the Harris hip score ( HHS ) at 6 weeks postoperatively . Patient-centered question naires were obtained preoperatively and after 6 weeks and 1 year . Results For the patients in the MIS group ( average 7.8 cm incision length ) , statistically significant increased mean HHSs were seen compared with the CLASS group at 6 weeks and 1 year . This difference was small and mainly caused by the favorable results of the PL-MIS . In the MIS group , surgical time was longer . A learning curve was observed based on operation time and complication rate . Although not statistically significant , the perioperative complication rate was rather high in the ( anterolateral ) MIS group . Conclusions The minimal invasive approach in THA did not show a clinical ly relevant superior outcome in the first postoperative year . Level of Evidence Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence",
"Introduction Minimally invasive total hip arthroplasty ( THA ) is cl aim ed to be superior to the st and ard technique , due to the potential reduction of soft tissue damage via a smaller and tissue-sparing approach . As a result of the lack of objective evidence of fewer muscle and tendon defects , controversy still remains as to whether minimally invasive total hip arthroplasty truly minimizes muscle and tendon damage . Therefore , the objective was to compare the influence of the surgical approach on abductor muscle trauma and to analyze the relevance to postoperative pain and functional recovery . Material s and methods Between June 2006 and July 2007 , 44 patients with primary hip arthritis were prospect ively included in the study protocol . Patients underwent cementless unilateral total hip arthroplasty either through a minimally invasive anterolateral approach ( ALMI ) ( n = 21 ) or a modified direct lateral approach ( mDL ) ( n = 16 ) . Patients were evaluated clinical ly and underwent MR imaging preoperatively and at 3 and 12 months postoperatively . Clinical assessment contained clinical examination , performance of abduction test and the survey of a function score using the Harris Hip Score , a pain score using a numeric rating scale ( NRS ) of 0–10 , as well as a satisfaction score using an NRS of 1–6 . Additionally , myoglobin and creatine kinase were measured preoperatively , and 6 , 24 and 96 h postoperatively . Evaluation of the MRI images included fatty atrophy ( rating scale 0–4 ) , tendon defects ( present/absent ) and bursal fluid collection of the abductor muscle . Results Muscle and tendon damage occurred in both groups , but more lateral gluteus medius tendon defects [ mDL 3/12mth . : 6 (37%)/4 ( 25 % ) ; ALMI : 3 (14%)/2 ( 9 % ) ] and muscle atrophy in the anterior part of the gluteus medius [ mean-st and ard ( 12 ) : 1.75 ± 1.8 ; mean-MIS ( 12 ) : 0.98 ± 1.1 ] were found in patients with the mDL approach . The clinical outcome was also poorer compared to the ALMI group . Significantly , more Trendelenburg ’s signs were evident and lower clinical scores were achieved in the mDL group . No differences in muscle and tendon damage were found for the gluteus minimus muscle . A higher serum myoglobin concentration was measured 6 and 24 h postoperatively in the mDL group ( 6 h : 403 ± 168 μg/l ; 24 h : 304 ± 182 μg/l ) compared to the ALMI group ( 6 h : 331 ± 143 μg/l ; 24 h : 268 ± 145 μg/l ) . Conclusion Abductor muscle and tendon damage occurred in both approaches , but the gluteus medius muscle can be spared more successfully via the minimally invasive approach and is accompanied by a better clinical outcome . Therefore , going through the intermuscular plane , without any detachment or dissection of muscle and tendons , truly minimizes perioperative soft tissue trauma . Furthermore , MRI emerges as an important imaging modality in the evaluation of muscle trauma in THA",
"BACKGROUND AIMS Evaluation of : 1 . early clinical and radiographic results of total hip arthroplasty ( THA ) through a st and ard lateral direct approach , 2 . early clinical and radiographic results of THA through a minimal lateral approach , 3 . comparison of the results of THA in these two groups . MATERIAL AND METHODS 120 THAs ( 60 cementless and 60 cemented ) done in 120 patients due to degenerative changes were evaluated prospect ively . 60 THAs were done through a minimal lateral approach and constituted a study group . 60 THAs were done through a direct lateral approach and constituted a control group . The mean age of the 120 patients ( 98 women and 22 men ) was 45 y.o . ( range : 32 - 67 y.o . ) . The duration of follow-up in the study group was from 6 to 12 months ( mean : 8.5 months ) . The duration of follow-up in the control group was from 10 to 16 months ( mean : 10.5 months ) . Mean preoperative functional status of the study group was 44.5 points according to the Harris hip score . Radiographic evaluation of the results was done according to the criteria of the Joint Committee of the Hip Society , AAOS and SICOT . RESULTS 6 months after THA , clinical results were 92 pts in the study group and 88 pts in the control group . Radiographic outcomes were very good in all 120 patients from both arms : there were no differences between the control and study group . The incidence of complications was similar in both groups . CONCLUSIONS Minimally invasive THA demonstrated its value in the treatment of degenerative changes of the hip joint with regard to short-term outcomes . The clinical and radiographic outcomes were comparable between the st and ard and minimally invasive approaches . Success with THA using a minimally invasive approach depends on excellent operative technique and experience with st and ard hip approaches rather than on the use of special instruments",
"Minimally invasive total hip arthroplasty using a short skin incision is a subject of much debate in the literature . The present study estimates the possible minimal length of the exposure in an unselected patient cohort and compares the lateral mini-incision technique and traditional total hip arthroplasty ( THA ) . One hundred and two patients were divided into three groups according to the type of surgery and length of incision : mini-incision ( less than 10 cm ) was performed in 38 patients ; midi-incision ( 10–14 cm ) in 43 ; and st and ard-incision ( longer than 14 cm ) in 21 patients . No statistical difference was found with regard to intraoperative and total blood loss , the rate of complications , and postoperative recovery . Significantly decreased body mass index ( BMI ) , shorter operative time , and higher number of hips with malpositioning of the acetabular cup were found in the mini-incision group . These patients , however , experienced less pain in the early postoperative period and were highly satisfied with the cosmetic results . The length of incision was shortened and optimized ( less than 14 cm ) in 82 % of patients , and mini-incision was performed in 38 patients of this unselected cohort . Because of the underst and able dem and of the patients for less invasive intervention , the surgeon should use a smaller but not necessarily mini-incision with minimal soft tissue trauma that still allows him to perform the procedure well , without compromising the type of implants and the otherwise excellent long-term results . R and omized prospect i ve studies are needed to explore the real value of the minimally invasive total hip arthroplasty . RésuméLa chirurgie arthroplastie de la hanche par voie mini invasive est un sujet de débat et de controverse dans la littérature . Cette étude a pour but d’estimer la longueur minimale de la voie d’abord sur une suite de patients non sélectionnés et de comparer la technique de mini incision avec la technique d’incision traditionnelle antérolatérale . Cent deux patients ont été divisés en trois groupes , en fonction du type de chirurgie et en fonction de la longueur d’incision . Premier groupe : mini incision moins de 10 cm chez 38 patients , deuxième groupe : incision moyenne 10 à 14 cm chez 43 patients et troisième groupe : incision st and ard , supérieure à 14 cm chez 21 patients . Aucune différence statistique n’a été trouvée pour la perte sanguine et sur le taux des complications post-opératoires . Dans le groupe des mini incisions peu de sujets avaient une surcharge pondérale , par contre , il existait un gr and nombre de hanches avec une mal position de la cupule . Ces patients ont cependant présenté moins de douleur dans la période post-opératoire et ont été très satisfaits du résultat cosmétique . La longueur de l’incision dans la chirurgie prothétique de la hanche peut être raccourcie et la longueur optimum peut être de moins de 14 cm chez 82 % des patients . Une mini incision a été réalisé dans cette série , chez 38 patients du fait de la dem and e des patients pour une chirurgie mini invasive , les chirurgiens ont utilisé une petite incision avec un minimum de traumatisme des tissus mous . Cette mini incision doit donc permettre au chirurgien de réaliser son intervention correctement sans compromission sur le type d ’ implants , ni sur la qualité des résultats à long terme . Il n’y a pas besoin pour cela nécessairement d’une mini incision néanmoins des études prospect ives r and omisées doivent être réalisées pour explorer le vrai résultat de la chirurgie arthroplastie par voie mini invasive",
"Patients are inquiring about mini-incision primary total hip arthroplasty with increasing frequency . There are no published r and omized controlled trials to substantiate cl aims that the mini-incision direct lateral approach is better than a st and ard approach . The purpose of our study was to review our initial experience with the mini-incision technique through the direct lateral approach , with the intent of implementing a r and omized controlled trial if the approach could be shown as safe and effective . Of importance was determining if there is any difference in component positioning and if there is any difference in intraoperative or postoperative complications between the two groups . We retrospectively compared a consecutive series of 87 primary total hip arthroplasties . Thirty-four total hip arthroplasties were done using a mini-incision direct lateral approach . The mean abduction angle was 45 ° for both groups . The femoral stem alignment was within five degrees of neutral in 97 % of the mini group and 94 % of the st and ard group . There were no dislocations , infections , neurologic or wound complications . There were no differences in medical complications or blood transfusions . A significant decrease was found regarding body mass index , which reflects the bias in patient selection and lack of r and omization . We conclude that it is safe to continue further study with this approach because as there was no increase in complications or component malpositioning . Level of Evidence : Therapeutic study , Level III ( retrospective comparative study ) . See the Guidelines for Authors for a complete description of levels of evidence",
"BACKGROUND Minimally invasive total hip arthroplasty has stirred substantial controversy with regard to whether it provides superior outcomes compared with total hip arthroplasty performed through longer incisions . The orthopaedic literature is deficient in well- design ed scientific studies to support the clinical superiority of this approach . The objective of this study was to compare the results of a single mini-incision approach with those of a st and ard-incision total hip arthroplasty in the early postoperative period . METHODS Two hundred and nineteen patients ( 219 hips ) admitted for unilateral total hip arthroplasty between December 2003 and June 2004 were r and omized to undergo surgery through a short incision of All patients were blinded to the size of the incision for the duration of the hospital stay . The anesthetic , analgesic , and postoperative physiotherapy protocol s were st and ardized , with the staff also blinded to the technique used . A single surgeon , who had performed more than 300 short-incision hip replacements prior to the start of this study and who performs an average of 415 primary total hip replacements a year , performed all procedures through a single-incision posterior approach using a cementless cup and cemented stem . RESULTS The two groups were matched for age , grade according to the system of the American Society of Anesthesiologists , and body mass index . No significant difference was detected with respect to postoperative hematocrit , blood transfusion requirements , pain scores , or analgesic use . We found no difference in early walking ability or length of hospital stay and no difference in component placement , cement-mantle quality , or functional outcome scores at six weeks . The patient variables significantly associated with a probability of early discharge independent of incision length were patient age and preoperative hemoglobin levels ( p surgical scars contracted significantly over six weeks ( p single-incision posterior approach by a high-volume hip surgeon with extensive experience in less invasive approaches to the hip is safe and reproducible . However , it offers no significant benefit in the early postoperative period compared with a st and ard incision of 16 cm . As it is not known whether lower-volume and less-experienced surgeons can achieve similar results , the mini-incision technique merits further study before wide dissemination and implementation of this family of surgical approaches can be recommended",
"In this study , interleukin-6 ( IL-6 ) , C-reactive protein ( CRP ) , and haemoglobin levels were evaluated to compare the degree of surgical invasion between mini and st and ard incisions in total hip arthroplasty ( THA ) . Sixty-two patients admitted for primary cementless THA were enrolled in this r and omised study . The patients were allocated to have surgery through either a mini incision of In each group , inflammatory responses were evaluated by IL-6 , CRP , and haemoglobin levels before operation and one day after operation . Significant differences were not found in IL-6 , CRP , and haemoglobin levels between both groups . At six months after surgery , there were no significant differences in postoperative Harris hip scores or radiographic evaluations between both groups . In conclusion , a 5.0 cm difference in the skin incision to the hip joint seemed to have no influence on the degree of surgical invasion during THA.RésuméAfin de mesurer l ’ importance de l’agression chirurgicale tissulaire dans les prothèses totales de hanche , incision st and ard , versus mini-invasifs , les niveaux d’Interleukin 6 ( IL-6 ) de protéine C-réactive ( CRP ) et d’hémoglobine doivent être appréciés . 62 patients devant bénéficier d’une prothèse totale de hanche primaire sans ciment ont été enrôlés dans cette étude r and omisée . Ces patients devaient bénéficier soit d’une mini-incision inférieure à 10 cm , soit d’une incision st and ard supérieure à 15 cm . Chaque groupe a été évalué avec ces différents facteurs biologiques avant l’intervention et un jour après intervention . Il n’a été trouvé aucune différence significative dans les deux groupes avec ces différents marqueurs Inteleukin , CRP et hémoglobine . Six mois après la chirurgie pas de différence significative non plus au niveau des scores de Harris ou au niveau de l’évaluation radiographique . En conclusion , la différence d’incision cutanée de 5 cm ne semble pas avoir d’influence sur l ’ importance des lésions des parties molles au cours d’une prothèse totale de hanche",
"AIMS Our primary aim was to evaluate whether there is really less bleeding in patients for whom the minimally invasive posterior approach is used in comparison with the direct lateral approach for primary total hip arthroplasty . Our secondary aim was to evaluate the clinical functional results after six months as well as the postoperative radiographic result . METHODS In a comparative non-r and om prospect i ve study , 76 adult patients underwent elective total hip arthroplasty using one of two approaches . The minimally invasive posterior approach ( 34 cases ; mini-incision group ) was compared with the st and ard direct lateral approach ( 42 cases ; control group ) . RESULTS Lower total estimated bleeding ( means of 1083.5 ml versus 1682.3 ml ; p lower intraoperative bleeding ( means of 745.6 ml versus 1282.8 ml ; p volume of blood drained after the operation ( means of 340 ml and 399 ml ; p = 0.77 ) . There was also a difference between the two groups regarding the need for allogenic transfusion ( 8.8 % in the mini-incision group versus 28.6 % , p = 0.02 ) . We observed a better clinical result in the mini-incision group ( p = 0.002 ) despite the lack of difference between the two groups in relation to the radiographic result . DISCUSSION Our results draw attention to the possibility that other authors may have underestimated blood losses when using minimally invasive approaches . CONCLUSION The minimally invasive approach gave rise to a positive final impression with regard to lower blood loss",
"Introduction Advantages of minimally invasive total hip arthroplasty ( THA ) are controversially discussed . Method In this prospect i ve study 51 patients ( 52 hips ) were r and omly allocated to a classical lateral or a minimally invasive approach ( modification of the Hardinge-approach ) . Operating time , intraoperative blood loss , postoperative hemoglobin , muscle enzymes CK and myoglobin were recorded . Radiologically the positioning of the prosthesis was analyzed . WOMAC- and Harris Hip Score ( HHS ) were assessed preoperatively , at discharge , at 6 weeks and 3 months . Results In the minimally invasive group there was a shorter length of surgery , the scores in the WOMAC and HHS were slightly better at discharge and at the 3 months- examination , myoglobin-rise was slightly less . The positioning of the prosthesis was good in both groups . Minimally invasive THA led to a quicker recovery , at 3 months postoperative there was still a slight difference to the st and ard group . Conclusion If these slight differences subside has to be examined in studies with a longer follow-up",
"Some surgeons have suggested that a minimally invasive two-incision approach allows total hip arthroplasty to be done without cutting or damaging any muscle or tendon . To our knowledge that cl aim has not been supported by any published clinical or basic science data . Our purpose in doing this study was to quantify the extent and location of damage to the abductor and external rotator muscles and tendons after two-incision and mini-posterior total hip arthroplasty . Ten cadavers ( 20 hips ) were studied . In each cadaver one hip r and omly was assigned to the two-incision group and the contralateral hip was assigned to the mini-posterior group . After inserting the total hip arthroplasty components the muscle damage was assessed using a technique described previously . Damage to the muscle of the gluteus medius and gluteus minimus was substantially greater with the two-incision technique than with the mini-posterior technique . Every two-incision total hip replacement caused measurable damage to the abductors , the external rotators , or both . Every mini-posterior hip replacement caused the external rotators to detach during the exposure and had additional measurable damage to the abductor muscles and tendon . We do not support the contention that a two-incision total hip arthroplasty is done without cutting muscle or tendon . None of the two-incision hip replacements were done without cutting , reaming , or damaging the gluteus medius or gluteus minimus muscle or external rotators",
"In this prospect i ve study we compared clinical and radiological results and rehabilitation progress of 64 patients who underwent total hip arthroplasty using the st and ard lateral approach with 64 patients operated with a minimal-invasive ( MIS ) posterior approach . The outcome of our study did not show any significant differences with regard to patient 's safety such as complication rate and radiological assessment of the cup position . There was no difference in the duration of surgery , blood loss , hospital stay and postoperative leg length discrepancy . Rehabilitation milestones were achieved earlier by MIS patients and three and six months postoperatively , the Harris Hip Score of the MIS group was significantly higher",
"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",
" A group of 42 primary total hip arthroplasties performed through an abridged surgical incision ( group 1 ) was prospect ively compared to a cohort of 42 primary total hip arthroplasties performed through a st and ard surgical incision ( group 2 ) . The length of the incision was 8.8 + /- 1.5 cm for group 1 and 23.0 + /- 2.1 cm for group 2 . The groups were not significantly different with respect to age , height , preoperative Harris Hip scores ( HHS ) , estimated blood loss , or length of hospital stay ( P>.05 ) . Group 1 patients had a lower body mass index than group 2 patients ( P Length of surgery was slightly less for group I ( P = .02 ) . A 0 % incidence was found of infection , nerve palsy , component malposition , and aseptic loosening in both groups . No dislocations occurred in group 1 , and one dislocation occurred in group 2 . Patients in group 1 have expressed considerable enthusiasm regarding the cosmetic appearance of the surgical incisions , and their postoperative HHS are slightly higher than those of group 2 ( P = .042 ) . Total hip arthroplasty can be performed safely and effectively through an abridged surgical incision , but this investigation confirms no dramatic clinical benefit other than cosmetic appeal",
"Anterolateral minimally invasive hip surgery ( ALMIS ) is a challenging procedure that is thought to offer a more expedient and a better functional outcome . Seventy-nine patients receiving primary hip arthroplasty were r and omized . Röttinger ALMIS technique was used for 42 patients , whereas 41 received the st and ard lateral transgluteal Hardinge approach . Operative time was longer with ALMIS ( P = .000078 ) , whereas blood loss was less ( P = .008 ) . Surgical and postoperative complication rates , morphine consumption , and length and cost of hospitalization were similar . At 1 year , Harris , Postel and Merle d'Aubigné , and Short Form-36v1 scores were similar . Gait analysis revealed similar results . Computed tomographic analysis revealed no significant difference in implant position , heterotopic ossification , and loosening . Röttinger ALMIS is a valid approach for hip arthroplasty . However , it offers no advantages at 1 year",
"Background The rehabilitation of patients for total hip arthroplasty is unsatisfactory , especially the prolonged rehabilitation . Aims To explore indications and key points of anterolateral minimally-invasive total hip arthroplasty . Methods 110 patients admitted for unilateral total hip arthroplasty were r and omly selected for surgery with either anterolateral minimally-invasive incision or st and ard posterolateral incision . Demographic data , perioperative index and postoperative function index were recorded and statistically analyzed . Results No significant difference was detected in operation time , abduction angle , anteversion angle , stem alignment and stem fixation . The incision length , blood loss , perioperative transfusion and 100-mm VAS score at the first 24 h in minimally-invasive group were significantly lower . The Harris hip score and Barthel index were significantly higher in minimally-invasive group at 3 months ’ follow-up , but not significantly different 3 years after operation . Conclusions There are fewer traumas , fewer blood losses and more rapid recovery in this approach",
"This prospect i ve study compares a mini-incision technique and traditional posterior approach for total hip arthroplasty ( THA ) . Thirty-three patients who had undergone a mini-incision THA were matched by diagnosis , gender , average age , and preoperative Harris Hip Score ( HHS ) to 33 patients who had undergone THA using the traditional posterior approach . The average length of the incision for group 1 was 11.7 cm ( range , 7.3 - 13.0 ) and for group 2 was 20.2 cm ( range , 14.8 - 26.0 ) . At the 3-month follow-up , patients in the mini-incision group had significant improvement in limp ( P ability to climb stairs ( P mini-incision group was significantly better in terms of limp ( P distance walked ( P stairs ( P pain , function , or range of motion at the 1-year follow-up examination",
"Patients without prior hip surgery and body mass index lower than 30 undergoing primary total hip arthroplasty were eligible to participate in a r and omized prospect i ve study comparing a minimally invasive with a st and ard approach . The patients were r and omized to receive incisions of 8 cm ( group A , n = 28 ) or 15 cm ( group B , n = 32 ) . The groups were similar demographically . Patients in group A had significantly less intraoperative blood loss ( P total blood loss ( P Operative time , transfusion requirements , narcotic usage , length of hospital stay , achievement of rehabilitation milestones , cane usage , and complications were similar in both groups . There was no difference between the groups at 1- and 2-year follow-up . Compared with a st and ard incision , patients who underwent a minimally invasive total hip arthroplasty demonstrated decreased blood loss and limped less at 6-week follow-up",
"BACKGROUND Few prospect i ve r and omized studies have demonstrated benefits of minimally invasive total hip arthroplasty when compared with conventional total hip arthroplasty . We hypothesized that patients treated with a posterior mini-incision would have better results than those treated with a posterior long incision with regard to the achievement of established goals for pain relief and functional recovery permitting hospital discharge by the second postoperative day . METHODS Sixty of 231 eligible patients were r and omized ( with thirty in each group ) to have a total hip arthroplasty performed through either a posterior mini-incision ( 10 + /- 2 cm ) or a traditional long incision ( 20 + /- 2 cm ) . After completion of the total hip arthroplasty , the mini-incision group underwent extension of the skin incision to 20 cm . Patients were evaluated on the basis of self-determined pain scores , requirements for pain medicine , need for assistive gait devices , and time until discharge . Gait analysis provided objective functional assessment . RESULTS The average hospital stay was 63.2 + /- 13.3 hours in the mini-incision group and 73.6 + /- 23.5 hours in the long-incision group ( p = 0.04 ) . More patients with a mini-incision were discharged by the second postoperative day ( p = 0.003 ) and more were using just a single assistive device at the time of discharge ( p = 0.005 ) . As scored on a verbal analog scale of 0 to 10 points , patients with a mini-incision had less pain on each postoperative day and the pain score remained significantly lower at the time of discharge ( mean , 2.2 + /- 1.0 points compared with 3.1 + /- 0.9 points in the long-incision group ; p = 0.002 ) . After hospital discharge , there were no clinical differences in pain or function between the two groups of patients . CONCLUSIONS Compared with conventional total hip arthroplasty performed through a posterior incision , posterior minimally invasive total hip arthroplasty result ed in better early pain control , earlier discharge to home , and less use of assistive devices . Subsequent evaluations at six weeks and three months showed equivalency between the clinical results in the two groups . LEVEL OF EVIDENCE Therapeutic Level",
"Technical and patient care improvements have occurred with the posterior mini-incision total hip arthroplasty . We hypothesized that these changes would provide better results for patients . The clinical and radiographic results of 100 total hip arthroplasties done with the posterior mini incision between January 2004 and October 2004 were compared with 100 mini-incision total hip arthroplasties done between December 2001 and September 2002 . There were no differences in diagnosis , age , and body mass index of the patients in each group . Component positions were not compromised in either group . There were improvements in the 2004 group with decreased hospital stay , reduction of postoperative pain and opioid analgesic use , reduced use of assistive devices , and earlier muscle recovery . In the 2004 group there were no complications of infection , dislocation , or sciatic palsy . The posterior mini-incision operation has shown improved results with experience and changes in technique and patient care treatment . Level of Evidence : Therapeutic study , Level IV ( case series ) . See the Guidelines for Authors for a complete description of levels of evidence",
"BACKGROUND Minimally invasive prosthetic hip surgery ( MIS ) attempts to minimise the extent of the operation . The aim of the study was to describe minimally invasive hip surgery and to present early clinical experience of the authors . MATERIAL AND METHODS 41 minimally invasive hip replacements through a posterior approach were carried out at the Orthopaedic Department of the Postgraduate Medical Education Centre in Otwock between 2004 and 2006 . 29 of those patients were included into the study , of whom 23 presented for follow-up . A control group consisted of 29 r and omly selected patients operated on using the classical method . Patients qualified for MIS had a BMI below 30 and a structurally normal hip joint with a good range of motion . RESULTS Early results were subjected to a statistical analysis of 20 parameters . CONCLUSION 1 . The analysis showed that statistically significant baseline differences between MIS and traditionally treated patients included only BMI scores , structure of the hip joint and range of motion . 2 . Implantation of a hip endoprosthesis in a MIS procedure does not differ from the traditional operation utilising a posterior access except for skin incision length"
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41180540-06ff-11f0-808a-c43d1ab1c353
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Exercise is a form of physical activity ( PA ) . PA is an important marker of health and quality of life in older adults . The purpose of this study was to conduct a systematic review of the literature to assess the effect of exercise-based interventions on an at least six-month follow up PA measure , and to describe the specific strategies implemented during the intervention to strengthen the sustainability of PA in community-dwelling 65 + year-old adults . We registered and conducted a systematic review and meta- analysis ( PROSPERO : CRD42017070892 ) of r and omized clinical trials ( RCT ) . We search ed three electronic data bases during January 2018 to identify RCT assessing any type of exercise-based intervention . Studies had to report a pre- , post- , and at least 6-month post-intervention follow-up . To be included , at least one PA outcome had to be assessed . The effect of exercise-based interventions was assessed compared to active ( e.g. , a low-intensity type of exercise , such as stretching or toning activities ) and non-active ( e.g. , usual care ) control interventions at several time points . Secondary analyses were conducted , restricted to studies that reported specific strategies to enhance the sustainability of PA . The intervention effect was measured on self-reported and objective measures of time spent in PA , by means of st and ardized mean differences . St and ardized mean differences of PA level were pooled . Pooled estimates of effect were computed with the DerSimonian-Laird method , applying a r and om effects model . The risk of bias was also assessed . We included 12 studies , comparing 18 exercise intervention groups to four active and nine non-active control groups . Nine studies reported specific strategies to enhance the long-term sustainability of PA . The strategies were mostly related to the self-efficacy , self-control , and behavior capability principles based on the social cognitive theory . Exercise interventions compared to active control showed inconclusive and heterogeneous results . When compared to non-active control , exercise interventions improved PA time at the six-months follow up ( st and ardized mean difference ( SMD ) 0.30 ; 95%CI 0.15 to 0.44 ; four studies ; 724 participants ; I2 0 % ) , but not at the one- or two-years follow-ups . No data were available on the mid- and long-term effect of adding strategies to enhance the sustainability of PA . Exercise interventions have small clinical benefits on PA levels in community-dwelling older adults , with a decline in the observed improvement after six months of the intervention cessation
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"Abstract Background Both exercise and vitamin D are recommended means to prevent falls among older adults , but their combined effects on fall-induced injuries are scarcely studied . Methods A 2-year follow-up of a previous 2-year r and omized controlled trial with vitamin D and exercise ( Ex ) of 409 older home-dwelling women using a factorial 2 × 2 design ( D−Ex− , D+Ex− , D−Ex+ , D+Ex+ ) . Besides monthly fall diaries , femoral neck bone mineral density ( fn-BMD ) , and physical functioning were assessed at 1 and 2 years after the intervention . Results After the intervention , S-25OHD concentrations declined to baseline levels in both supplement groups . The groups did not differ for change in fn-BMD or physical functioning , except for leg extensor muscle strength , which remained about 10 % greater in the exercise groups compared with the reference group ( D−Ex− ) . There were no between-group differences in the rate of all falls , but medically attended injurious falls reduced in D+Ex− and D−Ex+ groups compared with D−Ex−. However , all former treatment groups had less medically attended injured fallers , HRs ( 95 % CI ) being 0.62 ( 0.39–1.00 ) for D+Ex− , 0.46 ( 0.28–0.76 ) for D−Ex+ , and 0.55 ( 0.34–0.88 ) for D+Ex+ , compared with D−Ex−. Conclusions Exercise-induced benefits in physical functioning partly remained 2 years after cessation of supervised training . Although there was no difference in the rate of all falls , former exercise groups continued to have lower rate of medically attended injured fallers compared with referents even 2 years after the intervention . Vitamin D without exercise was associated with less injurious falls with no difference in physical functioning",
"Purpose The aim of this systematic review is to assess the effect of different types of exercise on breast cancer-related lymphedema ( BCRL ) in order to eluci date the role of exercise in this patient group . Methods A systematic data search was performed using PubMed ( December 2016 ) . The review is focused on the rehabilitative aspect of BCRL and undertaken according to the PRISMA statement with Levels of Evidence ( LoE ) assessed . Results 11 r and omized controlled trials ( 9 with LoE 1a and 2 with LoE 1b ) that included 458 women with breast cancer in aftercare were included . The different types of exercise consisted of aqua lymph training , swimming , resistance exercise , yoga , aerobic , and gravity-resistive exercise . Four of the studies measured a significant reduction in BCRL status based on arm volume and seven studies reported significant subjective improvements . No study showed adverse effects of exercise on BCRL . Conclusion The evidence indicates that exercise can improve subjective and objective parameters in BCRL patients , with dynamic , moderate , and high-frequency exercise appearing to provide the most positive effects",
"Abstract Background Little is known about which behavior change strategies motivate older adults to increase their physical activity . Purpose The purpose of this study was to assess the relative effects of two sets of behavior change strategies to motivate increased physical activity among older adults : interpersonal and intrapersonal . Methods Community-dwelling older adults ( N = 102 , mean age = 79 ) were r and omized in a 2 × 2 factorial experiment to receive interpersonal ( e.g. , social support , friendly social comparison ; no , yes ) and /or intrapersonal ( e.g. , goal setting , barriers management ; no , yes ) behavior change strategies , combined with an evidence -based , physical activity protocol ( Otago exercise program ) and a physical activity monitor ( Fitbit One ™ ) . Results Based on monitor data , participants who received interpersonal strategies , compared to those who did not , increased their average minutes of total physical activity ( light , moderate , vigorous ) per week , immediately ( p = .006 ) and 6 months ( p = .048 ) post-intervention . Similar , increases were observed on measures of functional strength and balance , immediately ( p = .012 ) and 6 months ( p = .003 ) post-intervention . The intrapersonal strategies did not elicit a significant increase in physical activity or functional strength and balance . Conclusions Findings suggest a set of interpersonally oriented behavior change strategies combined with an evidence -based physical activity protocol can elicit modest , but statistically and clinical ly significant , increases in older adults ’ physical activity and functional strength and balance . Future research should replicate these findings and investigate the sustained quantity of physical activity elicited by these strategies and their impact on older adults ’ quality of life and falls . Trial Registration The Clinical Trials.gov registration identifier is NCT02433249",
"Introduction Studies had not yet overcome the most relevant barriers to physical activity ( PA ) adherence . An exercise referral scheme ( ERS ) with mechanisms to promote social support might enhance adherence to PA in the long term . Setting A r and omised controlled trial in 10 primary care centres in Spain . Objective To assess the effectiveness of a primary care-based ERS linked to municipal re sources and enhancing social support and social participation in establishing adherence to PA among adults over a 15-month period . Participants 422 insufficiently active participants suffering from at least one chronic condition were included . 220 patients ( 69.5 ( 8.4 ) years ; 136 women ) were r and omly allocated to the intervention group ( IG ) and 202 ( 68.2 ( 8.9 ) years ; 121 women ) to the control group ( CG ) . Interventions The IG went through a 12-week st and ardised ERS linked to community re sources and with inclusion of mechanisms to enhance social support . The CG received usual care from their primary care practice . Outcomes The main outcome measure was self-report PA with the International Physical Activity Question naire and secondary outcomes included stages of change and social support to PA practice . Data collection Participant-level data were collected via question naires at baseline , and at months 3 , 9 and 15 . Blinding The study statistician and research assessors were blinded to group allocation . Results Compared with usual care , follow-up data at month 15 for the ERS group showed a significant increase of self-reported PA ( IG : 1373±1845 metabolic equivalents ( MET ) min/week , n=195 ; CG : 919±1454 MET min/week , n=144 ; P=0.009 ) . Higher adherence ( in terms of a more active stage of change ) was associated with higher PA level at baseline and with social support . Conclusions Prescription from ordinary primary care centres staff yielded adherence to PA practice in the long term . An innovative ERS linked to community re sources and enhancing social support had shown to be sustainable in the long term . Trial registration number NCT00714831 ; Results",
"BACKGROUND : Physical activity ( PA ) reduces the rate of mobility disability , compared with health education ( HE ) , in at risk older adults . It is important to underst and aspects of performance contributing to this benefit . OBJECTIVE : To evaluate intervention effects on tertiary physical performance outcomes . DESIGN : The Lifestyle Interventions and Independence for Elders ( LIFE ) was a multi‐centered , single‐blind r and omized trial of older adults . SETTING : Eight field centers throughout the United States . PARTICIPANTS : 1635 adults aged 78.9 ± 5.2 years , 67.2 % women at risk for mobility disability ( Short Physical Performance Battery [ SPPB ] . INTERVENTIONS : Moderate PA including walking , resistance and balance training compared with HE consisting of topics relevant to older adults . OUTCOMES : Grip strength , SPPB score and its components ( balance , 4 m gait speed , and chair‐st and s ) , as well as 400 m walking speed . RESULTS : Total SPPB score was higher in PA versus HE across all follow‐up times ( overall P = .04 ) as was the chair‐st and component ( overall P for balance ( overall P = .12 ) , 4 m gait speed ( overall P = .78 ) , or grip strength ( overall P = .62 ) . However , 400 m walking speed was faster in PA versus HE group ( overall P = reduction of major mobility disability in the PA versus HE group was explained by change in SPPB score , while 39 % was explained by change in the chair st and component . CONCLUSION : Lower extremity performance ( SPPB ) was significantly higher in the PA compared with HE group . Changes in chair‐st and score explained a considerable portion of the effect of PA on the reduction of major mobility disability‐consistent with the idea that preserving muscle strength/power may be important for the prevention of major mobility disability ",
"Background and Purpose : We have developed a 12-week balance training program for older adults shown to improve fall-related concerns , gait speed , balance performance , and physical function . We hypothesized that this balance training would also contribute to higher habitual physical activity ( PA ) levels and improved health-related quality of life ( HRQoL ) . The primary aim was to evaluate short- and long-term effects of the balance training program on objective ly measured habitual PA in older adults with osteoporosis . Secondary aims were to assess the effects of the balance training on HRQoL , and to study whether any effects on PA were associated with changes in HRQoL , gait speed , balance performance , fall-related concerns , and physical function . Methods : A r and omized controlled trial with follow-up at 3 , 9 , and 15 months , including 91 participants with osteoporosis ( 75.6 ± 5.4 years ) , compared a balance training group ( n = 61 ) with a control group ( n = 30 ) . The primary outcome was effect on habitual PA measured as steps/day , dichotomized into less than 5000 or 5000 or more steps/day . Physical activity was assessed with pedometers ( Yamax ) and accelerometers ( Actigraph ) , HRQoL with the Short Form-36 ( SF-36 ) , gait with a GAITRite walkway , balance performance with Modified-Figure-Eight test and one-leg stance , fall-related concerns with Falls Efficacy Scale International , and physical function with the advanced lower extremity subscale of the question naire Late Life Function and Disability Instrument . Statistical methods used were multivariate logistic regression and logistic generalized estimating equation . Results : Sixty-eight participants completed the short-term follow-up at 3 months , and 53 participants completed the long-term follow-up at 15 months . Per- protocol analysis ( n = 68 ) showed that the odds ratio for having a daily step count of 5000 or more at 3 months was 6.17 ( 95 % confidence interval , 1.23 - 30.91 ) , P = .027 , for the intervention group compared with the control group . The longitudinal analysis ( n = 91 ) showed that the odds ratio for having a daily step count of 5000 or more at 15 months was 2.02 ( 95 % confidence interval , 0.88 - 4.64 ) , P = .096 , for the intervention group compared with the control group . The mental component sum of the SF-36 improved significantly from baseline to 3 months in the intervention group , and the physical component sum improved in both groups , but no statistically significant differences were found between groups . No associations were found between PA and changes in covariates . Discussion and Conclusions : The short-term evaluation showed that balance training increased habitual PA in community-dwelling older adults with osteoporosis . A significantly higher proportion of participants in the intervention group reached a level of 5000 or more steps/day , which is important for overall health . This effect was not associated with improvements in HRQoL , gait speed , balance performance , or fall-related concerns , and did not persist through the long-term follow-up . To accomplish a sustained PA change , a prolonged intervention or more support regarding habitual PA may be required , such as reinforcement with personalized behavior change counseling or PA on prescription",
"Summary This study showed that about a half of the exercise-induced gain in dynamic balance and bone strength was maintained one year after cessation of the supervised high-intensity training of home-dwelling elderly women . However , to maintain exercise-induced gains in lower limb muscle force and physical functioning , continued training seems necessary . Introduction Maintenance of exercise-induced benefits in physical functioning and bone structure was assessed one year after cessation of 12-month r and omized controlled exercise intervention . Methods Originally 149 healthy women 70–78 years of age participated in the 12-month exercise RCT and 120 ( 81 % ) of them completed the follow-up study . Self-rated physical functioning , dynamic balance , leg extensor force , and bone structure were assessed . Results During the intervention , exercise increased dynamic balance by 7 % in the combination resistance and balance-jumping training group ( COMB ) . At the follow-up , a 4 % ( 95 % CI : 1–8 % ) gain compared with the controls was still seen , while the exercise-induced isometric leg extension force and self-rated physical functioning benefits had disappeared . During the intervention , at least twice a week trained COMB subjects obtained a significant 2 % benefit in tibial shaft bone strength index compared to the controls . A half of this benefit seemed to be maintained at the follow-up . Conclusions Exercise-induced benefits in dynamic balance and rigidity in the tibial shaft may partly be maintained one year after cessation of a supervised 12-month multi-component training in initially healthy elderly women . However , to maintain the achieved gains in muscle force and physical functioning , continued training seems necessary",
"Background and aims : Restricted physical activity as a consequence of chronic disease or injury is a predictor of functional decline . The aim of this study was to test the hypothesis that a 6-month multidimensional training program would have sustained beneficial effects upon the physiological , functional and psychological condition of old women with a recent history of falls . Methods : Participants were 65 home-dwelling women ( 70–90 years ) identified from hospital records as having had an accidental fall . After assessment of muscle strength , balance performance , walking speed , balance confidence , and physical activity level , the participants were r and omly assigned to a control group ( n=33 ) or a training group ( n=32 ) , who performed a multidimensional training program including moderate resistance exercise and balance exercise twice weekly for 6 months . Measurements were repeated after 6 and 12 months . Results : Six months of multidimensional training result ed in significant improvements and between-group differences in isometric knee extension strength ( p trunk extension/flexion strength ( p habitual/maximal walking speed ( p balance performance ( p balance confidence . No between-group differences were found concerning number of falls or physical activity level during the one-year study period . Conclusions : A multi-dimensional training program produced significant improvements in physiological and functional risk factors for falls and disability in women aged 70–90 years with a recent history of falls",
"Objectives To determine whether a lifestyle integrated approach to balance and strength training is effective in reducing the rate of falls in older , high risk people living at home . Design Three arm , r and omised parallel trial ; assessment s at baseline and after six and 12 months . R and omisation done by computer generated r and om blocks , stratified by sex and fall history and concealed by an independent secure website . Setting Residents in metropolitan Sydney , Australia . Participants Participants aged 70 years or older who had two or more falls or one injurious fall in past 12 months , recruited from Veteran ’s Affairs data bases and general practice data bases . Exclusion criteria were moderate to severe cognitive problems , inability to ambulate independently , neurological conditions that severely influenced gait and mobility , resident in a nursing home or hostel , or any unstable or terminal illness that would affect ability to do exercises . Interventions Three home based interventions : Lifestyle integrated Functional Exercise ( LiFE ) approach ( n=107 ; taught principles of balance and strength training and integrated selected activities into everyday routines ) , structured programme ( n=105 ; exercises for balance and lower limb strength , done three times a week ) , sham control programme ( n=105 ; gentle exercise ) . LiFE and structured groups received five sessions with two booster visits and two phone calls ; controls received three home visits and six phone calls . Assessment s made at baseline and after six and 12 months . Main outcome measures Primary measure : rate of falls over 12 months , collected by self report . Secondary measures : static and dynamic balance ; ankle , knee and hip strength ; balance self efficacy ; daily living activities ; participation ; habitual physical activity ; quality of life ; energy expenditure ; body mass index ; and fat free mass . Results After 12 months ’ follow-up , we recorded 172 , 193 , and 224 falls in the LiFE , structured exercise , and control groups , respectively . The overall incidence of falls in the LiFE programme was 1.66 per person years , compared with 1.90 in the structured programme and 2.28 in the control group . We saw a significant reduction of 31 % in the rate of falls for the LiFE programme compared with controls ( incidence rate ratio 0.69 ( 95 % confidence interval 0.48 to 0.99 ) ) ; the corresponding difference between the structured group and controls was non-significant ( 0.81 ( 0.56 to 1.17 ) ) . Static balance on an eight level hierarchy scale , ankle strength , function , and participation were significantly better in the LiFE group than in controls . LiFE and structured groups had a significant and moderate improvement in dynamic balance , compared with controls . Conclusions The LiFE programme provides an alternative to traditional exercise to consider for fall prevention . Functional based exercise should be a focus for interventions to protect older , high risk people from falling and to improve and maintain functional capacity . Trial registration Australia and New Zeal and Clinical Trials Registry 12606000025538",
"BACKGROUND Physician counseling of patients to increase physical activity has had limited success in changing behavior . Providing organizational support to primary care providers and their patients may increase effectiveness . OBJECTIVE This study evaluates the effectiveness of a telephone-based intervention to increase physical activity among patients who exercised physical activity over a 6-month period . DESIGN This was a r and omized controlled trial , conducted from 1997 to 1998 , of 316 patients aged 18 to 65 who were recruited from a mailed health risk assessment . Baseline and 6-month post-intervention telephone assessment s were conducted by telephone . SETTING One family physician 's patients in a suburban community . INTERVENTION Three sessions of telephone-delivered motivational counseling . MAIN OUTCOME MEASURES Physical activity score ( 11-item Physician-Based Assessment and Counseling for Exercise [ PACE ] ) 6 months after the intervention . RESULTS After adjusting for baseline exercise , there was a significantly higher level of self-reported exercise among individuals r and omized to the intervention at the 6-month follow-up . The mean level of activity at follow-up for the intervention group was a PACE score of 5.37 , compared to 4.98 in the control group ( p Patients can be recruited using a health-screening question naire to receive a telephone-delivered behavioral intervention to successfully increase their physical activity levels",
"Prospect i ve controlled evidence supporting the efficacy of long-term exercise to prevent physical decline and reduce falls in old age is lacking . The present study aim ed to assess the effects of long-term music-based multitask exercise ( i.e. , Jaques-Dalcroze eurhythmics ) on physical function and fall risk in older adults . A 3-year follow-up extension of a 1-year r and omized controlled trial ( NCT01107288 ) was conducted in Geneva ( Switzerl and ) , in which 134 community-dwellers aged ≥65 years at increased risk of falls received a 6-month music-based multitask exercise program . Four years following original trial enrolment , 52 subjects ( baseline mean ± SD age , 75 ± 8 years ) who ( i ) have maintained exercise program participation through the 4-year follow-up visit ( “ long-term intervention group ” , n = 23 ) or ( ii ) have discontinued participation following original trial completion ( “ control group ” , n = 29 ) were studied . They were reassessed in a blind fashion , using the same procedures as at baseline . At 4 years , linear mixed-effects models showed significant gait ( gait speed , P = 0.006 ) and balance ( one-legged stance time , P = 0.015 ) improvements in the long-term intervention group , compared with the control group . Also , long-term intervention subjects did better on Timed Up & Go , Five-Times-Sit-to-St and and h and grip strength tests , than controls ( P program reduced the risk of falling ( relative risk , 0.69 ; 95 % confidence interval , 0.5–0.9 ; P = 0.008 ) . These findings suggest that long-term maintenance of a music-based multitask exercise program is a promising strategy to prevent age-related physical decline in older adults . They also highlight the efficacy of sustained long-term adherence to exercise for falls prevention",
"AIMS Cardiac rehabilitation including exercise training is of proven value in ischaemic heart disease . However , elderly patients frequently are not encouraged to participate in such programmes . This study evaluates the physiological effects and self-reported quality of life after an aerobic outpatient group-training programme in subjects above the age of 65 years . METHODS AND RESULTS A consecutive series of 101 patients ( males 80 % ) aged 65 - 84 ( mean 71 ) years recovering from an acute coronary event were r and omized to either a supervised out patient group-training programme ( n=50 ) or to a control group ( n=51 ) . The two groups were well balanced as regards clinical characteristics . The compliance in the training group was 87 % . Exercise tolerance increased in the trained group from 104 to 122 and 111 W after 3 and 12 months respectively . The corresponding values were 102 , 105 and 105 W among controls . Parameters , such as quality of life , self-estimated level of physical activity , fitness and well-being were grade d higher by the trained patients than those who served as controls on the two occasions of follow-up . CONCLUSIONS Aerobic group-training of elderly patients recovering from an acute coronary event beneficially influences physical fitness and several parameters expressing quality of life . Great care has to be taken to preserve the initial effects by continued training",
"BACKGROUND It is well recognized that physical activity ( PA ) is important for older adults ; yet , clinicians remain pessimistic about the ability of older adults with compromised function to adhere to long-term treatment and to maintain behavior change once treatment has been terminated . METHODS We examined the functional status of older adults at a field center ( Wake Forest University ) 2 years after completing 12 months of treatment in the Lifestyle Interventions and Independence for Elders Pilot study . At baseline , participants were r and omized to either a PA or a successful aging ( SA ) control group . Outcome measures included an interview assessment of PA , the Short Physical Performance Battery ( SPPB ) , and performance on a 400-m self-paced walking test . RESULTS Two years after the formal intervention had ended , participants who were originally in the PA group continued to engage in more minutes of moderate PA and tended to have better SPPB and walking speed than those in the SA group ( effect sizes [ ES ] : SPPB = 0.40 , walking speed = 0.37 ) . Seven ( 12.7 % ) participants in the PA group failed the 400-m walk at the 36-month follow-up assessment , whereas this number was 11 ( 21.6 % ) in the SA group . CONCLUSION Older adults who have compromised physical function are able to sustain some of the benefits derived from participating in structured PA 2 years after supervised treatment has been terminated",
"BACKGROUND AND PURPOSE Physical activity and exercise as part of cardiac rehabilitation after an acute coronary event improves exercise capacity and quality of life in most patients . The aim of the present study was to evaluate physical activity level , health-related quality of life ( HRQL ) and perceived health three to six years after an acute myocardial infa rct ion or an episode of unstable angina pectoris in elderly patients and compare this to earlier follow-up examination data . METHOD STUDY DESIGN three to six years ( mean 4.4 years ) after r and omization a question naire about physical activity level , HRQL and perceived health was mailed to all subjects alive ( n = 93 ) ( response rate 96 % ) . The original study population consisted of 101 patients aged > or = 65 years admitted to the Coronary Care Unit at the Karolinska Hospital because of an acute coronary event between 1994 and 1997 . The patients were r and omized to either a three-month period of aerobic group training three times a week ( n = 50 ; acute myocardial infa rct ion 29 , unstable angina pectoris 21 ) or served as control subjects ( n = 51 ; acute myocardial infa rct ion 31 , unstable angina pectoris 20 ) . RESULTS Since the one-year follow-up examination eight subjects had died : five in the intervention group and three in the control group . At r and omization , the level of physical activity level was similar in the two groups . Those in the intervention group improved their level of physical activity significantly over time ( p = 0.05 ) in contrast to the control group . Measurements of HRQL showed no statistical difference between the groups by use of the EuroQol instrument . However , a small advantage for the intervention group measured over time was noted . CONCLUSION It is important to include elderly patients in cardiac rehabilitation programmes after an acute coronary event , since even a short period of supervised exercise training has the potential to positively influence physical activity level for as long as three to six years",
"Importance Effective long-term treatments are needed to address the obesity epidemic . Numerous wearable technologies specific to physical activity and diet are available , but it is unclear if these are effective at improving weight loss . Objective To test the hypothesis that , compared with a st and ard behavioral weight loss intervention ( st and ard intervention ) , a technology-enhanced weight loss intervention ( enhanced intervention ) would result in greater weight loss . Design , Setting , Participants R and omized clinical trial conducted at the University of Pittsburgh and enrolling 471 adult participants between October 2010 and October 2012 , with data collection completed by December 2014 . Interventions Participants were placed on a low-calorie diet , prescribed increases in physical activity , and had group counseling sessions . At 6 months , the interventions added telephone counseling sessions , text message prompts , and access to study material s on a website . At 6 months , participants r and omized to the st and ard intervention group initiated self-monitoring of diet and physical activity using a website , and those r and omized to the enhanced intervention group were provided with a wearable device and accompanying web interface to monitor diet and physical activity . Main Outcomes and Measures The primary outcome of weight was measured over 24 months at 6-month intervals , and the primary hypothesis tested the change in weight between 2 groups at 24 months . Secondary outcomes included body composition , fitness , physical activity , and dietary intake . Results Among the 471 participants r and omized ( body mass index [ BMI ] , 25 to , 470 ( 233 in the st and ard intervention group , 237 in the enhanced intervention group ) initiated the interventions as r and omized , and 74.5 % completed the study . For the enhanced intervention group , mean base line weight was 96.3 kg ( 95 % CI , 94.2 - 98.5 ) and 24-month weight 92.8 kg ( 95 % CI , 90.6- 95.0 ) [ corrected ] . For the st and ard intervention group , mean baseline weight was 95.2 kg ( 95%CI,93.0 - 97.3 ) and 24-month weight was 89.3 kg ( 95%CI , 87.1 - 91.5 ) [ corrected ] . Weight change at 24 months differed significantly by intervention group ( estimated mean weight loss , 3.5 kg [ 95 % CI , 2.6 - 4.5 } in the enhanced intervention group and 5.9 kg [ 95 % CI , 5.0 - 6.8 ] in the st and ard intervention group ; difference , 2.4 kg [ 95 % CI , 1.0 - 3.7 ] ; P = .002 ) . Both groups had significant improvements in body composition , fitness , physical activity , and diet , with no significant difference between groups . Conclusions and Relevance Among young adults with a BMI between 25 and less than 40 , the addition of a wearable technology device to a st and ard behavioral intervention result ed in less weight loss over 24 months . Devices that monitor and provide feedback on physical activity may not offer an advantage over st and ard behavioral weight loss approaches . Trial Registration clinical trials.gov Identifier : NCT01131871",
"OBJECTIVES To determine whether a clinic-based physical activity promotion intervention can lead to more community-based exercise referrals by providers and higher exercise motivation in patients . DESIGN Cluster r and omized , controlled trial . SETTING Seattle Veterans Affairs General Internal Medicine Clinic . PARTICIPANTS Thirty-one physicians and nurse practitioners were r and omized to a physical activity counseling intervention or control condition ( counseling about tobacco cessation ) . Three hundred thirty-six patients aged 50 and older and visiting a study provider were enrolled . INTERVENTION Intervention providers were trained to offer referrals to community exercise programs for patients who reported before their clinic visit that they were \" contemplative \" about regular exercise . MEASUREMENTS Process measures of health behavior assessment and provider advice , exercise stage-of-change , proportion of participants reporting regular physical activity . RESULTS At baseline , 172 intervention patients and 164 controls were similar with respect to sex , age , comorbidity score , and exercise motivation level . Forty-five percent of all intervention patients and 35 % of controls reported receiving exercise advice ( P=.07 ) . Intervention patients who were contemplative about exercise were even more likely to receive exercise advice than contemplative controls ( 59 % vs 38 % ; P=.02 ) . After 4 months , 35 % of all intervention patients reported regular exercise , compared with 28 % of controls ( P=.06 ) . CONCLUSION Primary providers are more likely to offer exercise advice when informed whether patients are contemplative about exercise . Patients may be more likely to start regular exercise as a result of this advice",
"OBJECTIVE To study the long-term outcome of a physical training regimen of ambulant postward rehabilitation in community-dwelling geriatric patients with a history of injurious falls . DESIGN Prospect i ve 2-year follow-up of a r and omized placebo-controlled intervention trial . SETTING Postward rehabilitation in a geriatric hospital in Germany . PARTICIPANTS Fifty-seven geriatric patients ( mean age , 84.3+/-4.4 y ) with a history of severe falls . INTERVENTION Ambulatory training of strength , functional performance , and balance 3 times a week for 3 months for 31 patients versus placebo activities for 26 patients . MAIN OUTCOME MEASURES Strength , functional performance , fall-related psychologic parameters , and physical activity assessed by st and ardized protocol s 2 years after the training intervention , compared with baseline results . RESULTS Motor performance decreased substantially in both groups . As patients in the intervention group declined from significantly improved motor performance levels achieved in the initial training intervention , differences between the groups were still significant in most functional performances 2 years later . Functional decline was greater in persons who were institutionalized or being cared for by family members . Physical activity , which increased during the exercise intervention , returned to low baseline levels . CONCLUSIONS Improved functional performance in the training group did not lead to an increased level of physical activity after training , which might have preserved the functional improvements . In mobility-restricted , frail , geriatric patients such as our study population , training programs should continue to keep patients active and to prevent the decline in strength and functional performance that precedes loss of autonomy",
"Background : Evidence for the effects of exercise and vitamin D supplementation on quality of life ( QoL ) , fear of falling ( FoF ) and mental wellbeing in older adults is conflicting . Objective : To study the effects of vitamin D supplementation and multimodal group exercise on psychosocial functions of wellbeing , including QoL , mental wellbeing and FoF. Method : This is a 2-year , double-blind , placebo-controlled vitamin D and open exercise intervention trial with 409 older Finnish women ( 70 - 80 years of age ) r and omized to 4 treatment arms : ( 1 ) placebo without exercise , ( 2 ) vitamin D ( 800 IU/day ) without exercise , ( 3 ) placebo and exercise , and ( 4 ) vitamin D ( 800 IU/day ) with exercise . Exercisers participated in group exercise twice per week for 12 months and once per week for the subsequent 12 months , plus home exercises . Results : When comparing with the placebo without exercise group , there were no statistically significant differences between groups receiving either vitamin D , exercise or both treatments for changes in QoL or mental wellbeing ( although a slight decline was seen in mental wellbeing in those receiving vitamin D only , p = 0.044 ) . The initial slight reduction in FoF was significant in all intervention groups compared with controls ( p vitamin D nor exercise contributes to better QoL , FoF or mental wellbeing in community-dwelling healthy older women with sufficient vitamin D levels",
"Objectives : To examine the effect that physical activity delivered via two different versions of the Green Prescription ( a primary care physical activity scripting program ) had on depressive symptomatology and general mental health functioning over a 12-month period in non-depressed , low-active , community-dwelling older adults . Method : Two hundred and twenty-five participants from the Healthy Steps study took part in the present study . Healthy Steps participants were r and omized to receive either the st and ard time-based or a modified pedometer-based Green Prescription . Depression , mental health functioning and physical activity were measured at baseline , post-intervention ( 3 months post-baseline ) and at the 9-month follow-up period . Results : At post-intervention , a positive association was found between increases in leisure-time physical activity and total walking physical activity and a decrease in depressive symptomatology ( within the non-depressed range of the GDS-15 ) and an increase in perceived mental health functioning , regardless of intervention allocation . These improvements were also evident at the follow-up period for participants in both intervention allocation groups . Conclusion : Our findings suggest that the st and ard time-based Green Prescription and a modified pedometer-based Green Prescription are both effective in maintaining and improving mental health in non-depressed , previously low-active older adults",
"Little is known about how physical and psychological status changes with time in older heart failure patients . The authors followed up a cohort of 82 patients ( mean age , 80.5 years ) enrolled in a r and omized controlled trial of exercise training in heart failure . Six-minute walk test , accelerometry , functional status , quality of life , anxiety , and depression were measured at baseline , 3 months , 6 months , and a mean of 19 months post-enrollment . There were no significant differences between the exercise and control groups at long-term follow-up . Six-minute walk distance declined by only 0.2 m/month in those attending final follow-up ( vs 4.6 m/month in nonattenders ; P=.03 ) . Similar results were seen for other outcomes . Only a small proportion of the variance in change of any of the outcomes was explained by differences in baseline variables",
"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",
"Abstract Background Despite the well‐known health benefits of physical activity , it is a great challenge to stay physically active for frail – older adults with mobility limitations . The aim of this study was to test the ( cost‐ ) effectiveness of a patient‐centred physical therapy strategy ( Coach2Move ) in which individualized treatment ( motivational interviewing , physical examination , individualized goal setting , coaching and advice on self management , and physical training ) is combined to increase physical activity level and physical fitness and , thereby , to decrease the level of frailty . Methods A r and omized controlled trial was performed in 13 physical therapy practice s with measurements at 3 and 6 months . Eligible patients were aged 70 years or over and had mobility problems ( i.e. difficulties with walking , moving , getting up and changing position from bed or chair to st and ing , or stair climbing ) . The primary outcome was physical activity ( total and moderate intensity ) in minutes per day . Secondary outcomes were as follows : frailty , walking speed and distance , mobility , and quality of life . Data were analysed using linear mixed models for repeated measurements . Healthcare costs and quality ‐adjusted life years ( QALYs ) were computed and combined using net monetary benefit ( NMB ) for different willingness to pay thresholds . Data on costs , QALYs , and NMBs were analysed using linear mixed models . Results One hundred and thirty patients participated in this study . At 6 months , the between‐group difference was significant for moderate‐intensity physical activity in favour of the Coach2Move group [ mean difference : 17.9 min per day ; 95 % confidence interval ( CI ) 4.0 to 34.9 ; P = 0.012 ] . The between‐group difference for total physical activity was 14.1 min per day ( 95 % CI −6.6 to 34.9 ; P = 0.182 ) . Frailty decreased more in the Coach2Move group compared with usual care [ mean difference : −0.03 ( 95 % CI : −0.06 to −0.00 ; P = 0.027 ) ] . Compared with usual treatment , the Coach2Move strategy result ed in cost savings ( € 849.8 ; 95 % CI : 1607 to 90 ; P = 0.028 ) , an improvement in QALYs , ( 0.02 ; 95 % CI : 0.00 to 0.03 ; P = 0.03 ) , and a higher NMB at every willingness to pay threshold . Conclusions Older adults with mobility problems are able to safely increase physical activity in their own environment and reduce frailty . This study emphasizes both the potential cost‐effectiveness of a patient‐centred approach in the frail elderly and the importance of physical activity promotion in older adults with mobility limitations"
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411805b8-06ff-11f0-808a-c43d1ab1c353
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This clinical practice guideline provides evidence -based recommendations for the treatment of children diagnosed with attention-deficit/hyperactivity disorder ( ADHD ) . This guideline , the second in a set of policies on this condition , is intended for use by clinicians working in primary care setting s. The initiation of treatment requires the accurate establishment of a diagnosis of ADHD ; the American Academy of Pediatrics ( AAP ) clinical practice guideline on diagnosis of children with ADHD(1 ) provides direction in appropriately diagnosing this disorder . The AAP Committee on Quality Improvement selected a subcommittee composed of primary care and developmental-behavioral pediatricians and other experts in the fields of neurology , psychology , child psychiatry , education , family practice , and epidemiology . The subcommittee partnered with the Agency for Healthcare Research and Quality and the Evidence -based Practice Center at McMaster University , Ontario , Canada , to develop the evidence base of literature on this topic.(2 ) The result ing systematic review , along with other major studies in this area , was used to formulate recommendations for treatment of children with ADHD . The subcommittee also review ed the multimodal treatment study of children with ADHD(3 ) and the Canadian Coordinating Office for Health Technology Assessment report (CCOHTA).(4 ) Subcommittee decisions were made by consensus where definitive evidence was not available . The subcommittee report underwent extensive review by sections and committees of the AAP as well as by numerous external organizations before approval from the AAP Board of Directors . The guideline contains the following recommendations for the treatment of a child diagnosed with ADHD
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"This study assessed the safety and efficacy of methylpheni date in children with seizures and attention-deficit disorder . Ten children , aged 6 years 10 months to 10 years 10 months , without seizures while receiving a single antiepileptic drug , were evaluated in a double-blind medication-placebo crossover study with methylpheni date hydrochloride was administered at 0.3 mg/kg per dose and given at 8 AM and 12 PM on school days only . The use of methylpheni date was associated with statistically significant improvements on the Conners ' Teacher Rating Scale and on the Finger Tapping Task and with trends toward improvement on the Matching Familiar Figures Test and Discriminant Reaction Time tests . No child had seizures during the study period nor subsequently for those who continued receiving psychostimulants . There were no significant changes of epileptiform features or back-ground activity on electroencephalograms and no alterations in antiepileptic drug levels . Methylpheni date may be a safe and effective treatment for certain children with seizures and concurrent attention-deficit disorder",
"OBJECTIVE To study the safety and efficacy of methylpheni date in children with the dual diagnosis of epilepsy and attention deficit hyperactivity disorder ( ADHD ) . STUDY DESIGN Thirty children , aged 6.4 to 16.4 years , with epilepsy and ADHD were studied during a 4-month period . During the initial 2 months of the study , the children were treated with antiepileptic drugs ( AEDs ) only , and for the remaining 2 months , methylpheni date was added at a morning dose of 0.3 mg/kg . They underwent neurologic assessment , brain computed tomography , IQ testing , and assessment with the Childhood Behavior Checklist at baseline before methylpheni date therapy . Electroencephalography , AED determinations , and the continuous-performance task ( CPT ) test were done at baseline and after 2 months of methylpheni date therapy . A double-blind , crossover design was used to compare the effects of methylpheni date versus placebo on an electroencephalogram , AED levels , and the CPT . On the 2 days of testing , the child received AEDs and a capsule containing either placebo or methylpheni date . RESULTS None of the 25 children of this sample who were seizure free had attacks while taking methylpheni date . Of the 5 children with seizures , 3 had an increase in attacks , whereas the other 2 showed no change or a reduction . There were no significant changes in AED levels or electroencephalographic findings . Methylpheni date benefited 70 % of children according to parental report ; methylpheni date also enhanced performance on the CPT . Side effects of methylpheni date were mild and transient . CONCLUSION Methylpheni date is effective in treating children with epilepsy and ADHD and safe in children who are seizure free . Caution is warranted for those still having seizures while receiving AED therapy",
"OBJECTIVE To compare the side effect profiles of methylpheni date ( MPH ) and dexamphetamine ( DEX ) in children with attention deficit hyperactivity disorder ( ADHD ) , as well as to determine which symptoms are genuine adverse effects of stimulant medication , as opposed to aspects of the child 's underlying behavioral phenotype . DESIGN Double-blind , crossover study . SETTING Pediatric teaching hospital ambulatory behavior clinic . SUBJECTS A total of 125 children with ADHD with a mean age of 104.8 months . INTERVENTIONS Subjects received DEX ( 0.15 mg/kg/dose ) and MPH ( 0.3 mg/kg/dose ) twice a day for 2 weeks each in a r and omized order . OUTCOME MEASURES The Barkley Side Effects Rating Scale ( 17 symptoms ; 0 = absent , severity rated from 1 to 9 ) was completed by parents at baseline and at the completion of each trial fortnight . RESULTS Subjects ' parents reported a significantly greater mean number ( 8.19 ) and mean severity ( 4.08 ) of \" side effects \" before commencing the trial than during the MPH period ( number 7.19 ; severity 3.24 ) , but not the DEX period ( number 7.64 , severity 3.73 ) . The mean severity ( but not mean number ) was greater on DEX than on MPH . DEX caused more severe insomnia and appetite suppression compared with the baseline rating . Appetite suppression was the only item rated more severe on MPH than at baseline . Six side effects were significantly more severe on DEX than MPH : insomnia , irritability , proneness to crying , anxiousness , sadness/unhappiness , and nightmares . None were more severe on MPH than DEX . Overall , both MPH and DEX were well tolerated by most subjects , with only four subjects discontinuing the trial period because of severe adverse effects ( 2 -1.6%- on each stimulant ) . CONCLUSIONS Many symptoms commonly attributed to stimulant medication are actually preexisting characteristics of children with ADHD and improve with stimulant treatment . At the doses investigated , both DEX and MPH caused appetite suppression , and DEX caused insomnia . Negative emotional symptoms were more severe on DEX than MPH",
"OBJECTIVE To determine the effects of methylpheni date ( MPH ) and dextroamphetamine ( DEX ) on tic severity in boys with attention-deficit/hyperactivity disorder ( ADHD ) comorbid with Tourette 's syndrome . METHOD A 9-week , placebo-controlled , double-blind crossover using a wide range of doses was completed by 20 subjects in three cohorts . RESULTS Relatively high doses of MPH and DEX in the first cohort produced significant increases in tic severity which were sustained on higher doses of DEX but which attenuated on MPH . Overall , 14 of 20 subjects continued stimulant treatment for 1 to 3 years , generally in combination with other psychotropics . Stimulant-associated adverse effects , including tic exacerbations , were reversible in all cases . CONCLUSION A substantial minority of comorbid subjects had consistent worsening of tics on stimulants , although the majority experienced improvement in ADHD symptoms with acceptable effects on tics . MPH was better tolerated than DEX",
"BACKGROUND Four cases of sudden death in children 12 years or younger during desipramine treatment were identified between 1986 and 1992 . We evaluated whether these events support the hypothesis that exposure to therapeutic doses of desipramine contributes to the risk for sudden death in otherwise healthy children . METHOD The National Center for Health Statistics provided the baseline number of sudden unexplained deaths in children 5 to 14 years old . Data from the National Disease and Therapeutic Index were used to estimate the exposure to desipramine in children in the same age group . Since two of the four deaths were identified by 1987 , we used the post-1987 experience as if it were a prospect i ve period in which a causal association could be examined . RESULTS The number of sudden deaths in desipramine-exposed children did not increase from 1986 to 1992 despite a marked increase in exposure . By using 4 to 6 months as the average lifetime of a desipramine prescription and a baseline rate of sudden death of 4.2 deaths/million/year in this population , the post-1987 period would account for 162,000 to 242,000 person-years of desipramine exposure . Although not statistically significant , this level of exposure corresponds to a relative risk of 2.1 ( 95 % CI = 0.5 to 15 ) to 3.1 ( 95 % CI = 0.8 to 22 ) . CONCLUSION Although , based on our estimates , the evidence for an association between desipramine and sudden death in children aged 5 to 14 years appears weak , replication of our findings is needed with a more precise numerator ( total number of deaths ) and denominator ( the appropriate conversion from drug appearance to actual exposure ) before a firm conclusion on this subject can be drawn . Until then , even if remote , the possibility of an association between desipramine and sudden death in children stresses the importance of assessing risks and benefits when desipramine is used in pediatric patients",
"OBJECTIVE This is a multisite , double-blind , placebo-controlled trial to determine the safety and efficacy of bupropion in the treatment of children with attention deficit disorder with hyperactivity ( ADDH ) . METHOD In a four-center , double-blind comparison of bupropion ( n = 72 ) and placebo ( n = 37 ) , children aged 6 to 12 years meeting DSM-III criteria for ADDH were r and omized to receive bupropion 3 to 6 mg/kg per day or placebo , administered twice daily , at 7 A.M. and 7 P.M. Measures of efficacy included the Conners Parent and Teacher Question naires ( 93-item , 39-item , and 10 item ) , Clinical Global Impressions Scales of Severity and Improvement , the Sternberg Short-Term Memory Task , and the Continuous Performance Test . Screen and posttreatment physical examinations , electrocardiograms , electroencephalograms , and clinical laboratory evaluations were performed . Height , weight , and vital signs were measured and adverse experiences were assessed weekly . RESULTS A significant treatment effect , apparent as early as day 3 , was present for both conduct problems and hyperactivity on the Conners 10-item and 39-item teacher 's checklist , and at day 28 for conduct problems and restless-impulsive behavior on the 93-item parent question naire . Findings were of smaller magnitude for parent ratings than teacher ratings . Significant treatment effects were present on both the Continuous Performance Test and memory retrieval test . Effect sizes of bupropion/placebo differences for teacher and parent ratings in this study were somewhat smaller than for st and ard stimulant drugs used to treat ADDH . Bupropion appeared to be well tolerated in most children . Dermatological reactions were twice as frequent in the drug group as the placebo group , with four reactions involving rash and urticaria that were serious enough to require discontinuation of medication . CONCLUSIONS Bupropion may be a useful addition to available treatments for ADDH . Comparative trials with such st and ard drugs as methylpheni date are warranted to determine the relative clinical merits of bupropion",
"The behavioral , cognitive , and electrophysiological effect of a single dose of dextroamphetamine ( 0.5 milligram per kilogram of body weight ) or placebo was examined in 14 normal prepubertal boys ( mean age , 10 years 11 months ) in a double-blind study . When amphetamine was given , the group showed a marked decrease in motor activity and reaction time and improved performance on cognitive tests . The similarity of the response observed in normal children to that reported in children with \" hyperactivity \" or minimal brain dysfunction casts doubt on pathophysiological models of minimal brain dysfunction which assume that children with this syndrome have a clinical ly specific or \" paradoxical \" response to stimulants",
"BACKGROUND This study examined changes in attention-deficit hyperactivity ( ADHD ) behaviors and motor and vocal tics during long-term treatment with methylpheni date . METHODS Thirty-four prepubertal children with ADHD and chronic multiple tic disorder ( who had participated in an 8-week , double-blind , placebo-controlled methylpheni date evaluation ) were evaluated at 6-month intervals for 2 years as part of a prospect i ve , nonblind , follow-up study . Treatment effects were assessed using direct observations of child behavior in a simulated ( clinic-based ) classroom and behavior rating scales completed by parents and physician . Videotapes of the simulated classroom were scored by coders who were blind to treatment status . RESULTS There was no evidence ( group data ) that motor tics or vocal tics changed in frequency or severity during maintenance therapy compared with diagnostic or initial double-blind placebo evaluations . Behavioral improvements demonstrated during the acute drug trial were maintained during follow-up . There was no evidence ( group data ) of clinical ly significant adverse drug effects on cardiovascular function or growth at the end of 2 years of treatment . CONCLUSIONS Long-term treatment with methylpheni date seems to be safe and effective for the management of ADHD behaviors in many ( but not necessarily all ) children with mild to moderate tic disorder . Nevertheless , careful clinical monitoring is m and atory to rule out the possibility of drug-induced tic exacerbation in individual patients",
"OBJECTIVE This study evaluated the effects on behavior and sleep of methylpheni date ( MPH ) administered at 4 PM to children with attention-deficit hyperactivity disorder ( ADHD ) . METHODOLOGY Twelve children admitted to a child psychiatric inpatient service with ADHD participated in a double-blind , crossover study in which they received a 4 PM dose of either 15 mg of MPH , 10 mg of MPH , or a placebo in r and om order for 12 consecutive days . Ratings of behavior , including ADHD symptoms , pertaining to the period from dose administration until sleep onset , were supplied nightly by hospital staff . Sleep latency and sleep adequacy were also assessed for each night . RESULTS MPH result ed in markedly improved behavioral control compared with placebo ; there was no difference between 15-mg and 10-mg MPH doses . MPH did not alter sleep latencies observed with the placebo . Children were more often rated as less tired on awakening after nights that they received 10 mg of MPH compared with 15 mg of MPH and the placebo . Weight loss was apparent among 83 % of the patients , but dinner intake did not vary with third-dose condition . CONCLUSIONS Morning and noon administration of stimulants to children with ADHD is a near-universal practice , but many clinicians avoid a third , late-afternoon administration for fear of inducing insomnia . This study 's findings show that children with ADHD derive substantial symptom reduction from MPH administered in late afternoon , with no untoward effects on sleep . Therefore , three-times-a-day dosing should be considered for those children exhibiting ADHD symptoms in the evening . Adverse effects on sleep latency were not apparent in the sample overall . Nonetheless , monitoring for possible aggravation of sleep problems and weight loss remains sound treatment practice"
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41180644-06ff-11f0-808a-c43d1ab1c353
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Most people presenting with incident osteoporotic fractures are neither assessed nor treated for osteoporosis to reduce their risk of further fractures , despite the availability of effective treatments . We evaluated the effectiveness of published models of care for the secondary prevention of osteoporotic fractures . We search ed eight medical literature data bases to identify reports published between 1996 and 2011 , describing models of care for secondary fracture prevention . Information extracted from each publication included study design , patient characteristics , identification strategies , assessment and treatment initiation strategies , as well as outcome measures ( rates of bone mineral density ( BMD ) testing , osteoporosis treatment initiation , adherence , re-fractures and cost-effectiveness ) . Meta-analyses of studies with valid control groups were conducted for two outcome measures : BMD testing and osteoporosis treatment initiation . Out of 574 references , 42 articles were identified as analysable . These studies were grouped into four general models of care — type A : identification , assessment and treatment of patients as part of the service ; type B : similar to A , without treatment initiation ; type C : alerting patients plus primary care physicians ; and type D : patient education only . Meta-regressions revealed a trend towards increased BMD testing ( p = 0.06 ) and treatment initiation ( p = 0.03 ) with increasing intensity of intervention . One type A service with a valid control group showed a significant decrease in re-fractures . Types A and B services were cost-effective , although definition of cost-effectiveness varied between studies . Fully coordinated , intensive models of care for secondary fracture prevention are more effective in improving patient outcomes than approaches involving alerts and /or education only
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"CONTEXT There are few data on long-term mortality following osteoporotic fracture and fewer following subsequent fracture . OBJECTIVES To examine long-term mortality risk in women and men following all osteoporotic fractures and to assess the association of subsequent fracture with that risk . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort from the Dubbo Osteoporosis Epidemiology Study of community-dwelling women and men aged 60 years and older from Dubbo , Australia , who sustained a fracture between April 1989 and May 2007 . MAIN OUTCOME MEASURES Age- and sex-specific st and ardized mortality ratios ( SMRs ) compared with the overall Dubbo population for hip , vertebral , major , and minor fractures . RESULTS In women , there were 952 low-trauma fractures followed by 461 deaths , and in men , 343 fractures were followed by 197 deaths . Age-adjusted SMRs were increased following hip fractures ( SMRs , 2.43 [ 95 % confidence interval [ CI ] , 2.02 - 2.93 ] and 3.51 [ 95 % CI , 2.65 - 4.66 ] ) , vertebral fractures ( SMRs , 1.82 [ 95 % CI , 1.52 - 2.17 ] and 2.12 [ 95 % CI , 1.66 - 2.72 ] ) , major fractures ( SMRs , 1.65 [ 95 % CI , 1.31 - 2.08 ] and 1.70 [ 95 % CI , 1.23 - 2.36 ] ) , and minor fractures ( SMRs , 1.42 [ 95 % CI , 1.19 - 1.70 ] and 1.33 [ 95 % CI , 0.99 - 1.80 ] ) for both women and men , respectively . Mortality was increased for all ages for all fractures except minor fractures for which increased mortality was only apparent for those older than 75 years . Increased mortality risk persisted for 5 years for all fractures and up to 10 years for hip fractures . Increases in absolute mortality that were above expected , for 5 years after fracture , ranged from 1.3 to 13.2 per 100 person-years in women and from 2.7 to 22.3 per 100 person-years in men , depending on fracture type . Subsequent fracture was associated with an increased mortality hazard ratio of 1.91 ( 95 % CI , 1.54 - 2.37 ) in women and 2.99 ( 95 % CI , 2.11 - 4.24 ) in men . Mortality risk following a subsequent fracture then declined but beyond 5 years still remained higher than in the general population ( SMR , 1.41 [ 95 % CI , 1.01 - 1.97 ] and SMR , 1.78 [ 95 % CI , 0.96 - 3.31 ] for women and men , respectively ) . Predictors of mortality after any fragility fracture for both men and women included age , quadriceps weakness , and subsequent fracture but not comorbidities . Low bone mineral density , having smoked , and sway were also predictors for women and less physical activity for men . CONCLUSIONS In a sample of older women and men , all low-trauma fractures were associated with increased mortality risk for 5 to 10 years . Subsequent fracture was associated with increased mortality risk for an additional 5 years",
"Background Despite accurate diagnostic tests and effective therapies , the management of osteoporosis has been observed to be suboptimal in many setting s. We tested the effectiveness of an intervention to improve care in patients at-risk of osteoporosis . Design R and omized controlled trial . Participants Primary care physicians and their patients at-risk of osteoporosis , including women 65 years and over , men and women 45 and over with a prior fracture , and men and women 45 and over who recently used ≥90 days of oral glucocorticoids . InterventionA multifaceted program of education and reminders delivered to primary care physicians as well as mailings and automated telephone calls to patients . Outcome : Either undergoing a bone mineral density ( BMD ) testing or filling a prescription for a bone-active medication during the 10 months of follow-up . Results After the intervention , 144 ( 14 % ) patients in the intervention group and 97 ( 10 % ) patients in the control group received either a BMD test or filled a prescription for an osteoporosis medication . This represents a 4 % absolute increase and a 45 % relative increase ( 95 % confidence interval 9–93 % , p = 0.01 ) in osteoporosis management between the intervention and control groups . No differences between groups were observed in the incidence of fracture . Conclusion An intervention targeting primary care physicians and their at-risk patients increased the frequency of BMD testing and /or filling prescriptions for osteoporosis medications . However , the absolute percentage of at-risk patients receiving osteoporosis management remained low",
"BACKGROUND Mortality increases after hip fractures in women and more so in men . Little is known , however , about mortality after other fractures . We investigated the mortality associated with all fracture types in elderly women and men . METHODS We did a 5-year prospect i ve cohort study in the semi-urban city of Dubbo , Australia , of all residents aged 60 years and older ( 2413 women and 1898 men ) . Low-trauma osteoporotic fractures that occurred between 1989 and 1994 , confirmed by radiography and personal interview , were classified as proximal femur , vertebral , and groupings of other major and minor fractures . We calculated st and ardised mortality rates from death certificates for people with fractures compared with the Dubbo population . FINDINGS 356 women and 137 men had low-trauma fractures . In women and men , mortality was increased in the first year after all major fractures . In women , age-st and ardised mortality ratios were 2.18 ( 95 % CI 2.03 - 2.32 ) for proximal femur , 1.66 ( 1.51 - 1.80 ) for vertebral , 1.92 ( 1.70 - 2.14 ) for other major , and 0.75 ( 0.66 - 0.84 ) for minor fractures . In men , these ratios were 3.17 ( 2.90 - 3.44 ) for proximal femur , 2.38 ( 2.17 - 2.59 ) for vertebral , 2.22 ( 1.91 - 2.52 ) for other major , and 1.45 ( 1.25 - 1.65 ) for minor fractures . There were excess deaths ( excluding minor fractures in women ) in all age-groups . INTERPRETATION All major fractures were associated with increased mortality , especially in men . The loss of potential years of life in the younger age-group shows that preventative strategies for fracture should not focus on older patients at the expense of younger women and of men",
"Summary Implementation of case findings according to guidelines for osteoporosis in fracture patients presenting at a Fracture Liaison Service ( FLS ) was evaluated . Despite one guideline , all FLSs differed in the performance of patient selection and prevalence of clinical risk factors ( CRFs ) indicating the need for more concrete and st and ardised guidelines . Introduction The aim of the study was to evaluate the implementation of case findings according to guidelines for osteoporosis in fracture patients presenting at FLSs in the Netherl and s. Methods Five FLSs were contacted to participate in this prospect i ve study . Patients older than 50 years with a recent clinical fracture who were able and were willing to participate in fracture risk evaluation were included . Performance was evaluated by criteria for patient recruitment , patient characteristics , nurse time , evaluated clinical risk factors ( CRFs ) , bone mineral density ( BMD ) and laboratory testing and results of CRFs and BMD are presented . Differences between FLSs were analysed for performance ( by chi-square and Student ’s t test ) and for prevalence of CRFs ( by relative risks ( RR ) ) . Results All FLSs had a dedicated nurse spending 0.9 to 1.7 h per patient . During 39 to 58 months follow-up , 7,199 patients were evaluated ( 15 to 47 patients /centre/month ; mean age , 67 years ; 77 % women ) . Major differences were found between FLSs in the performance of patient recruitment , evaluation of CRFs , BMD and laboratory testing , varying between 0 % and 100 % . The prevalence of CRFs and osteoporosis varied significantly between FLSs ( RR between 1.7 and 37.0 , depending on the risk factor ) . Conclusion All five participating FLSs with a dedicated fracture nurse differed in the performance of patient selection , CRFs and in the prevalence of CRFs , indicating the need for more concrete and st and ardised guidelines to organise evaluation of patients at the time of fracture in daily practice",
"CONTEXT There are few published long-term data on absolute risk of subsequent fracture ( refracture ) following initial low-trauma fracture in women and fewer in men . OBJECTIVE To examine long-term risk of subsequent fracture following initial osteoporotic fracture in men and women . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study ( Dubbo Osteoporosis Epidemiology Study ) in Australia of 2245 community-dwelling women and 1760 men aged 60 years or older followed up for 16 years from July 1989 through April 2005 . MAIN OUTCOME MEASURE Incidence of first ( initial ) fracture and incidence of subsequent fracture according to sex , age group , and time since first fracture . Relative risk was determined by comparing risk of subsequent fracture with risk of initial fracture . RESULTS There were 905 women and 337 men with an initial fracture , of whom 253 women and 71 men experienced a subsequent fracture . Relative risk ( RR ) of subsequent fracture in women was 1.95 ( 95 % confidence interval [ CI ] , 1.70 - 2.25 ) and in men was 3.47 ( 95 % CI , 2.68 - 4.48 ) . As a result , absolute risk of subsequent fracture was similar in women and men and at least as great as the initial fracture risk for a woman 10 years older . Thus , women and men aged 60 to 69 years had absolute refracture rates of 36/1000 person-years ( 95 % CI , 26 - 48/1000 ) and 37/1000 person-years ( 95 % CI , 23 - 59/1000 ) , respectively . The increase in absolute fracture risk remained for up to 10 years , by which time 40 % to 60 % of surviving women and men experienced a subsequent fracture . All fracture locations apart from rib ( men ) and ankle ( women ) result ed in increased subsequent fracture risk , with highest RRs following hip ( RR , 9.97 ; 95 % CI , 1.38 - 71.98 ) and clinical vertebral ( RR , 15.12 ; 95 % CI , 6.06 - 37.69 ) fractures in younger men . In multivariate analyses , femoral neck bone mineral density , age , and smoking were predictors of subsequent fracture in women and femoral neck bone mineral density , physical activity , and calcium intake were predictors in men . CONCLUSION After an initial low-trauma fracture , absolute risk of subsequent fracture was similar for men and women . This increased risk occurred for virtually all clinical fractures and persisted for up to 10 years",
"Summary Few out patients with fractures are treated for osteoporosis in the years following fracture . In a r and omized pilot study , we found a nurse case-manager could double rates of osteoporosis testing and treatment compared with a proven efficacious quality improvement strategy directed at patients and physicians ( 57 % vs 28 % rates of appropriate care ) . Introduction Few patients with fractures are treated for osteoporosis . An intervention directed at wrist fracture patients ( education ) and physicians ( guidelines , reminders ) tripled osteoporosis treatment rates compared to controls ( 22 % vs 7 % within 6 months of fracture ) . More effective strategies are needed . Methods We undertook a pilot study that compared a nurse case-manager to the multifaceted intervention using a r and omized trial design . The case-manager counseled patients , arranged bone mineral density ( BMD ) tests , and prescribed treatments . We included controls from our first trial who remained untreated for osteoporosis 1-year post-fracture . Primary outcome was bisphosphonate treatment and secondary outcomes were BMD testing , appropriate care ( BMD test-treatment if bone mass low ) , and costs . Results Forty six patients untreated 1-year after wrist fracture were r and omized to case-manager ( n = 21 ) or multifaceted intervention ( n = 25 ) . Median age was 60 years and 68 % were female . Six months post-r and omization , 9 ( 43 % ) case-managed patients were treated with bisphosphonates compared with 3 ( 12 % ) multifaceted intervention patients ( relative risk [ RR ] 3.6 , 95 % confidence intervals [ CI ] 1.1–11.5 , p = 0.019 ) . Case-managed patients were more likely than multifaceted intervention patients to undergo BMD tests ( 81 % vs 52 % , RR 1.6 , 95%CI 1.1–2.4 , p = 0.042 ) and receive appropriate care ( 57 % vs 28 % , RR 2.0 , 95%CI 1.0–4.2 , p = 0.048 ) . Case-management cost was $ 44 ( CDN ) per patient vs $ 12 for the multifaceted intervention . Conclusions A nurse case-manager substantially increased rates of appropriate testing and treatment for osteoporosis in patients at high-risk of future fracture when compared with a multifaceted quality improvement intervention aim ed at patients and physicians . Even with case-management , nearly half of patients did not receive appropriate care . Trial Registry clinical trials.gov identifier :",
"Summary In the present prospect i ve controlled observational study , we investigated the effect of a coordinated intervention program on 4-year refracture rates in patients with recent osteoporotic fractures . Compared to st and ard care , targeted identification , and management significantly reduced the risk of refracture by more than 80 % . Introduction The risk of refracture following an incident osteoporotic fracture is high . Despite the availability of treatments that reduce refracture and mortality rates , most patients with minimal trauma fracture ( MTF ) are not managed appropriately . The present prospect i ve controlled observational study investigated the effect of a coordinated intervention program on 4-year refracture rates and time to refracture in patients with recent osteoporotic fractures . Methods Patients presenting with a non-vertebral MTF were actively identified and offered referral to a dedicated intervention program . Patients attending the clinic underwent a st and ardized set of investigations , were treated as indicated and review ed at 12-monthly intervals ( ‘ MTF group ’ ) . Patients who elected to follow-up with their primary care physician were assigned to the concurrent control group . Results Groups were balanced for baseline anthropometric , socio-economic , and clinical risk factors . Over 4 years , 10 out of 246 patients ( 4.1 % ) in the MTF group and 31 of 157 patients ( 19.7 % ) in the control group suffered a new fracture , with a median time to refracture of 26 and 16 months , respectively ( p risk of refracture was increased by 5.3-fold in the control group ( 95 % CI : 2.8–12.2 , p patients presenting with a minimal trauma non-vertebral fracture , active identification and management significantly reduces the risk of refracture ( Australian New Zeal and Clinical Trials Registry ACTRN 12606000108516 )",
"Summary This study assessed whether osteoporosis diagnosis and treatment after an osteoporotic fracture can be increased by providing osteoporosis reading material to patients and family doctors or by watching a videocassette about osteoporosis . Educating patients about osteoporosis had little impact on whether a woman received an osteoporosis diagnosis or treatment . Introduction The purpose of this study was to investigate the impact of two education-based interventions on osteoporosis diagnosis and treatment in women ≥50 years of age after fragility fracture . Methods Six to eight months after fracture , women were r and omized into three groups : ( 1 ) control , ( 2 ) written material s , or ( 3 ) videocassette and written material s. Written material s for both the patient and physician detailed osteoporosis , fragility fracture , and available treatments ; written material s for physicians were provided through patients . The educational videocassette presented similar information as the written material , but in greater depth . Rates of osteoporosis diagnosis and treatment following intervention were compared among groups using survival analysis methods . Statistical significance was set at p At r and omization , 1,174 women were without osteoporosis diagnosis and treatment , and after follow-up , 12 % of the control group , 15 % of the written material s group ( p = 0.073 ) , and 16 % ( p = 0.036 ) of the videocassette and written material s group were diagnosed with osteoporosis ( statistical comparisons to control ) . Treatment rates were 8 % for the control group , 12 % for the written material s group ( p = 0.052 ) , and 11 % for the videocassette and written material s group ( p = 0.157 ) . At r and omization , 1,314 women were without treatment and after follow-up therapy was initiated in 10 % of the control group , 13 % of the written material s group ( p = 0.107 ) , and 13 % of the videocassette and written material s group ( p = 0.238 ) . Conclusions The educational interventions assessed in this trial were not satisfactory to increase osteoporosis diagnosis or treatment in recently fractured women to a clinical ly meaningful degree",
"OBJECTIVES Osteoporosis treatment rates after a fracture are low . This study evaluated methods to increase guideline -recommended osteoporosis care postfracture . DESIGN Participants were r and omly assigned to usual care or one of two interventions . Analysis of primary outcomes used electronic data and linear regression . SETTING A Pacific Northwest nonprofit health maintenance organization . PARTICIPANTS Female patients aged 50 to 89 who suffered a fracture in 1999 and had not received bone mineral density ( BMD ) measurement or medication for osteoporosis ( n=311 ) and their primary care providers ( n=159 ) . INTERVENTION Patient-specific clinical guideline advice to the primary care provider delivered by electronic medical record ( EMR ) message or electronic reminder to the provider plus an educational letter mailed to the patient . MEASUREMENTS BMD measurement and osteoporosis medication . RESULTS At 6 months , provider reminder result ed in 51.5 % of patients receiving BMD measurement or osteoporosis medication , provider reminder plus patient education result ed in 43.1 % , and usual care result ed in 5.9 % ( P Patients aged 60 to 69 were 18 % ( 95 % confidence interval=3 - 34 ) more likely to receive BMD measurement or an osteoporosis medication than those aged 80 to 89 . CONCLUSION Patient-specific postfracture advice to the provider through an EMR message significantly increased BMD measurement and osteoporosis medication . As EMRs become more widespread , this intervention could improve osteoporosis management for many postfracture patients . Future research should identify barriers to and facilitators of care for older , high-risk patients",
"Introduction Despite the high risk for subsequent fracture following an initial osteoporotic fracture , the majority of subjects with minimal trauma fractures receive no treatment for osteoporosis . The primary aim of this investigation was to determine whether an information-based intervention could change post-fracture management of osteoporosis . A secondary aim was to define participant- and doctor-related barriers to osteoporosis management . Methods Consecutive fracture patients ( n=254 ) from the outpatient fracture clinic at St Vincent ’s Hospital , Sydney were interviewed over a 15-month period ( February 2002–July 2003 ) . Fracture risk factors , prior investigation and treatment for osteoporosis were collected at baseline . Participants were initially contacted after 3 months to ascertain follow-up management . All those not investigated or treated by their primary care physician were then r and omized to either a personalized letter or the same letter plus an offer of a free bone mineral density ( BMD ) test . Participants were contacted after 9 months to record further investigations or treatment for osteoporosis . Results Less than 20 % of the participants had a primary care physician follow-up 3 months after the fracture , leaving 159 who were r and omized to a personalized letter ( n=79 ) and a personalized letter plus the offer of a free BMD test ( n=80 ) . There was a significant increase in the number of people investigated for osteoporosis in the group receiving the letter plus BMD offer [ 38 % ( letter + BMD ) vs. 7 % ( letter only ) ; p=0.001 ) . A high proportion of those tested had low BMD ( 49 % osteopenia and 17 % osteoporosis ) . However , the rates of treatment in both groups were very low ( 6 % ) . Furthermore , even among the few individuals ( 23 % ) who contacted their primary care physician , only 25 % were recommended treatment . The belief that the fracture was osteoporotic was an independent predictor of having a BMD test , a primary care physician follow-up and treatment . Other independent predictors were age over 50 years for a primary care physician follow-up , female sex for having a BMD test and having had a BMD test for treatment . Conclusion This study demonstrates that an information-based intervention led to a modest increase in the proportion of people investigated for osteoporosis ; however . there was no significant effect on treatment rates . The offer of a free BMD assessment was associated with a significantly higher rate of investigation than a personalized letter alone ( odds ratio : 8.5 ; 95 % confidence interval : 3.1–24.5 ) , but this investigation did not affect treatment rate . The low uptake of either a BMD or a visit to a primary care physician together with low rates of treatment recommendation even among people who contacted their primary care physician reflects significant participant and doctor-related barriers to osteoporosis management",
"Summary We evaluated the cost-effectiveness of a fracture liaison service prospect ively design ed to have a parallel control group treated by st and ard care . The clinical effectiveness of this service was associated with an incremental cost-effectiveness ratio versus st and ard care of Australian dollars ( AUD ) 17,291 per quality -adjusted life year ( QALY ) gained . Introduction Osteoporotic fractures are a major burden for national health services . The risk of re-fracture following an osteoporotic fracture is particularly high . In a study unique in prospect ively having a control group treated by st and ard care , we recently demonstrated that a Minimal Trauma Fracture Liaison ( MTFL ) service significantly reduces the risk of re-fracture by 80 % . Since the service involves greater use of re sources , we have now evaluated whether it is cost-effective . Methods A Markov model was developed that incorporated fracture probabilities and re source utilization data ( expressed in AUD ) obtained directly from the 4-year MTFL service clinical study . Re source utilization , local cost and mortality data and fracture-related health utility data were used to calculate QALYs with the MTFL service and st and ard care . Main outcome measures were : additional costs of the MTFL service over st and ard care , the financial savings achieved through reduced fractures and changes in QALYs associated with reduced fractures calculated over a 10-year simulation period . Costs and QALYs were discounted at 5 % annually . Sensitivity analyses quantified the effects of different assumptions of effectiveness and re source utilization associated with the MTFL service . Results The MTFL service improved QALYs by 0.089 years and led to increased costs of AUD 1,486 per patient versus st and ard care over the 10-year simulation period . The incremental cost-effectiveness ratio versus st and ard care was AUD 17,291 per QALY gained . Results were robust under all plausible assumptions . Conclusions The MTFL service is a cost-effective intervention to reduce recurrent osteoporotic fractures",
"Summary In a cluster r and omized trial , we evaluated the effect of a multifaceted intervention ( directed at both patient and primary care physician ) on the rates of testing and treatment of osteoporosis in postmenopausal women within six months of their wrist fracture . Compared to usual care , women in the intervention practice s were three times more likely to receive bone mineral density testing and prescribed osteoporosis treatments . Introduction Postmenopausal women with wrist fractures are at increased risk of future fragility fractures , yet they frequently do not receive evaluation and treatment for osteoporosis . We set out to evaluate a multifaceted intervention design ed to improve management of osteoporosis in older women with recent wrist fractures . Methods Cluster r and omized trial of 270 women cared for in 119 primary care practice s. We recruited postmenopausal women with an acute wrist fracture from the emergency departments of hospitals in southeastern Ontario , Canada . Family practice s were r and omly assigned to either the intervention or usual care . The intervention consisted of a mailed reminder with a summary of treatment guidelines and letter sent to the primary care physician , in addition to an educational package and letter to the women . The primary outcome was the proportion of women prescribed osteoporosis therapy within 6 months of their fracture . Results The mean age of women was 69(10.9 ) years . The intervention increased the proportion of women started on osteoporosis medications ( 28 % vs. 10 % ) of controls , adjusted OR 3.45 , 95 % CI , 1.58–7.56 , p = 0.002 ) and the proportion who had a bone mineral density ( BMD ) test ( 53.3 % vs. 26 % ) of controls , OR 3.38 , 95 % CI , 1.83–6.26 , p testing and treatment rates . Conclusion A multifaceted intervention significantly improved rates of osteoporosis treatment and BMD testing in postmenopausal women with wrist fractures",
"Context Many patients who sustain fragility fractures do not receive subsequent testing and treatment for osteoporosis . Contribution This study shows that faxed reminders to physicians , treatment guidelines endorsed by opinion leaders , and patient education about osteoporosis can increase the testing and therapy for osteoporosis among patients who present to an emergency department with wrist fracture . Caution s This study did not r and omly assign persons to the intervention group and did not examine improvements in bone density or repeated fractures . The Editors Osteoporosis , a chronic and progressive condition that leads to decreased bone mass and skeletal fragility , may result in fractures , disability , pain , deformity , and even death ( 1 - 3 ) . The condition is common , affecting an estimated 1.4 million Canadians and 10 million Americans ( 1 , 2 ) . These figures represent 25 % of women and 12 % of men older than 50 years of age ( 1 , 2 ) . In the United States , the annual cost of treating osteoporosis and its sequelae has been estimated at $ 13.8 billion ( 2 ) , compared with $ 7.5 billion for congestive heart failure and $ 6.2 billion for asthma ( 3 ) . Without better preventive strategies , the rate of osteoporotic fractures is expected to double over the next 15 years ( 4 ) . Several experts ( 5 ) and guidelines ( 1 , 2 ) suggest a preventive strategy of identifying people with typical osteoporosis-related fractures ( for example , fractures of the hip , spine , or wrist [ often called fragility fractures ] ) and targeting them for treatment . They recommend this strategy because this population is at the greatest risk for subsequent fracture and may derive the greatest absolute benefit from treatment . Numerous safe and effective treatments can reduce the risk for recurrent fracture by 40 % to 60 % ( 1 - 3 , 6 ) . In addition , with the use of bisphosphonates and raloxifene , all subgroups of examined patients may obtain beneficial effects ( 3 , 7 - 9 ) within a year ( 7 , 8) . People 50 years of age and older with a fracture of the wrist may be particularly well suited to a strategy of case finding and secondary prevention . Fractures of the wrist are the most common symptomatic fracture related to osteoporosis ( 3 ) , and 70 % to 80 % of persons with wrist fractures have low bone mass ( 10 , 11 ) . Observational studies suggest that a wrist fracture is a sentinel event in the natural history of osteoporosis because this type of fracture forecasts an increased risk for fractures of the hip and spine over the next 10 to 20 years ( 12 - 14 ) . Best practice ( clinical practice consistent with current evidence and expert consensus ) would be to identify people 50 years of age or older with a fragility fracture of the wrist , to measure their bone mineral density , and to treat those with low bone mass or osteoporosis ( 1 , 2 , 5 ) . However , the gap between best practice and everyday clinical practice is wide . Over the past 5 to 10 years , studies from the United States ( 3 , 15 , 16 ) , Canada ( 17 , 18 ) , and elsewhere ( 5 , 19 ) report that rates of testing for and treating osteoporosis a year or longer after a fracture of the wrist are less than 10 % to 20 % . This is an important failure in the process of knowledge translation and indicates that benefits within our reach are not being achieved . We design ed a pragmatic , multifaceted osteoporosis intervention strategy directed at people 50 years of age or older with a fracture of the wrist and at their primary care physicians . The intervention consisted of physician reminders , treatment guidelines endorsed by local opinion leaders , and patient education . Our primary objective was to examine whether this intervention improved the diagnosis and treatment of osteoporosis in this high-risk population . Secondary objectives included examining the effect of this intervention on patients ' knowledge , satisfaction , and quality of life . Methods Setting and Participants Capital Health ( Edmonton , Alberta ) is one of the largest integrated health service delivery organizations in Canada ( 20 ) . It provides comprehensive health services for about 1 million people and has an annual budget of almost $ 2 billion ( Canadian ) ( 20 ) . Primary care is delivered by approximately 900 fee-for-service physicians . We enrolled participants from the 2 largest emergency departments in the region : the University of Alberta Hospital ( a university-based teaching hospital ) and the Royal Alex and ra Hospital ( a university-affiliated community teaching hospital ) . These emergency departments provide most of the fracture care and emergency orthopedic services to the region . Consecutive patients presenting to the emergency department with a wrist fracture were potentially eligible . Inclusion criteria were as follows : age 50 years or older ; any simple , closed fracture of the distal forearm ; and discharge home . We excluded patients who were already taking prescription treatments for osteoporosis . Because we did not ask patients whether they had a diagnosis of osteoporosis until study closeout , a patient with a history of osteoporosis who was not being treated with prescription medication was potentially eligible for inclusion . We also excluded patients who were unable to provide consent , were unwilling to participate , were admitted to the hospital , resided in a long-term care facility , resided outside the Capital Health region , or could not read and converse in English . Study Design and Patient Enrollment We conducted a prospect i ve controlled trial with blinded ascertainment of outcomes . To allocate patients to the intervention or usual care control groups , we adapted and modified an onoff 1-site study design for 2 sites ( 21 ) . For 1 month at a time , in sequential order , the intervention was on at 1 emergency department while it was off at the other . At the end of each month , research nurses alternated intervention status from on to off or vice versa . Patients with wrist fractures were treated , as appropriate , by emergency department physicians and then approached by research nurses or orthopedic technicians for enrollment in the study before discharge home . We obtained informed consent from each patient , and all data were maintained outside the emergency departments in a central ized secure file system . The University of Alberta Health Research Ethics Board approved the study . Intervention We design ed an intervention to overcome the many barriers that exist for primary care physicians who are trying to adopt evidence -based treatments for their patients with osteoporosis . Each of the 3 components of the intervention had published evidence of effectiveness ( 22 - 24 ) . Physician Reminders A reminder was generated for each patient and faxed to the primary care physician of record . The reminder notified physicians that their patient had recently been seen and treated in the emergency department for a wrist fracture and reminded them that their patient was now considered to be at increased risk for osteoporosis . Generating and sending the personalized and patient-specific reminder took about 6 minutes for each patient . Treatment Guidelines Generated and Endorsed by Opinion Leaders As part of the reminder , we provided brief evidence -based treatment recommendations . These guidelines were design ed to fit on the same page and emphasized 3 points : 1 ) The patient is at very high risk for osteoporosis and needs a bone mineral density measurement if one has not been performed in the past year ; 2 ) without treatment , the patient may be at increased risk for another fracture within the year ; and 3 ) bisphosphonate treatment will reduce the patient 's risk for fracture by about 50 % . Bisphosphonate alternatives ( for example , calcitonin , raloxifene , and hormone therapy ) were mentioned as second-line approved treatments because , at the time of study design , only the bisphosphonates had been demonstrated to prevent both vertebral and nonvertebral fractures . Using previously vali date d methods ( 25 , 26 ) , we recruited 5 osteoporosis opinion leaders who had been nominated by local primary care providers . The opinion leaders helped develop and then endorsed the guidelines by attaching their names and signatures . Patient Education We provided patients in the intervention group with a tailored , single-page summary of osteoporosis information that mirrored the physician material s described in the preceding paragraph . We reinforced these written material s with a brief telephone counseling session that took place within 1 week of the fracture . This counseling ( approximately 4 minutes per session ) reiterated the content of the written material s and encouraged patients to seek further information and counseling from their primary care physician . We did not provide intervention patients with any written material s or counseling regarding fall prevention or home safety . Control Patients ( Usual Care ) On the basis of surveys and in-depth interviews with emergency department physicians in Canada and the United States , the current st and ard of care for patients treated for a wrist fracture usually consists of 1 ) notification to the primary care physician of record that the patient was seen and treated and 2 ) information on follow-up plans . We ensured that such notifications occurred for all control patients . In addition , we enhanced usual care by ensuring that control patients received educational material s and telephone counseling regarding fall prevention and home safety . During the call , patients were encouraged to visit their primary care physician for more detailed advice and a medication review . They did not receive any counseling or educational material s about osteoporosis . Thus , control patients received the same amount of attention and care as the intervention patients . After the main study was completed , all control patients were crossed over to the osteoporosis intervention , and all intervention patients were provided with counseling regarding fall prevention and home safety . Outcomes and Measurements The primary study outcome was",
"BACKGROUND Treatment of osteoporosis following a hip fracture has been notoriously poor . Many efforts have been made to improve treatment rates . The purpose of this study was to determine whether a perioperative inpatient intervention program , involving patient education and providing a list of questions for the primary care physician , increased the percentage of patients in whom osteoporosis was addressed following a hip fracture . METHODS A prospect i ve , r and omized trial involving eighty patients who had been admitted to an academic medical center with a low-energy hip fracture was conducted . During their hospitalization , the study group patients were engaged in a fifteen-minute discussion regarding the association between osteoporosis and hip fractures , the efficacy of dual-energy x-ray absorptiometry scans in the diagnosis of osteoporosis and of bisphosphonates in its treatment , and the importance of medical follow-up for osteoporosis management . These patients were also provided with five questions regarding osteoporosis treatment to be given to their primary medical physician , and they were reminded about the questions during a follow-up telephone call six weeks later . The patients in the control group received a brochure describing methods for preventing falls . Both groups were contacted by telephone at six months after discharge to determine whether osteoporosis had been addressed . Positive indicators of intervention included assessment of bone mineral density with dual-energy x-ray absorptiometry and initiation of antiresorptive therapy . RESULTS The average age in each group was eighty-two years , and 78 % of the patients were female . Four patients in each group did not survive through the six-month follow-up period and were excluded from the trial . Fifteen ( 42 % ) of the thirty-six patients who had been r and omized to the study group , compared with only seven ( 19 % ) of the thirty-six patients in the control group , had their osteoporosis addressed by their primary physician . This difference between the groups was significant ( p = 0.036 ) . CONCLUSIONS Patients who were provided with information and questions for their primary care physician about osteoporosis were more likely to receive appropriate therapeutic intervention than were patients who had not received the information and questions . Orthopaedic surgeons have a unique opportunity to improve the rate of osteoporosis treatment in the perioperative period following a hip fracture by educating patients and directing them toward channels for long-term osteoporosis management",
"Background : Older patients who experience a fragility fracture are at high risk of future fractures but are rarely tested or treated for osteoporosis . We developed a multifaceted intervention directed at older patients with wrist fractures ( in the form of telephone-based education ) and their physicians ( in the form of guidelines endorsed by opinion leaders , supported by reminders ) to improve the quality of osteoporosis care . Methods : In a r and omized controlled trial with blinded ascertainment of outcomes , we compared our intervention with usual care ( provision of printed educational material s to patients ) . Eligible patients were those older than 50 years of age who had experienced a wrist fracture and were seen in emergency departments and fracture clinics ; we excluded those who were already being treated for osteoporosis . The primary outcome was bisphosphonate treatment within 6 months after the fracture . Secondary outcomes included bone mineral density testing , “ appropriate care ” ( consisting of bone mineral density testing with treatment if bone mass was low ) and quality of life . Results : We screened 795 patients for eligibility and r and omly assigned 272 to the intervention ( 137 patients ) or control ( 135 patients ) group . The median age was 60 years ; 210 ( 77 % ) of the subjects were women , and 130 ( 48 % ) reported a previous fracture as an adult . Six months after the fracture , 30 ( 22 % ) of the intervention patients , as compared with 10 ( 7 % ) of the control patients , were receiving bisphosphonate therapy for osteoporosis ( adjusted relative risk [ RR ] 2.6 , 95 % confidence interval [ CI ] 1.3–5.1 , p = 0.008 ) . Intervention patients were more likely than control patients to undergo bone mineral density testing ( 71/137 [ 52 % ] v. 24/135 [ 18 % ] ; adjusted RR 2.8 , 95 % CI 1.9–4.2 , p receive appropriate care ( 52/137 [ 38 % ] v. 15/135 [ 11 % ] ; adjusted RR 3.1 , 95 % CI 1.8–5.3 , p died , and 4 others experienced recurrent fracture . Interpretation : A multifaceted intervention directed at high-risk patients and their physicians substantially increased rates of testing and treatment for osteoporosis . Nevertheless , more than half of the patients in the intervention group were not receiving appropriate care 6 months after their fracture , which suggests that additional strategies should be explored . ( Clinical Trials.gov trial register no. NCT00152321 .",
"BACKGROUND Patients who survive hip fracture are at high risk of recurrent fractures , but rates of osteoporosis treatment 1 year after sustaining a fracture are less than 10 % to 20 % . We have developed an osteoporosis case manager intervention . The case manager educated patients , arranged bone mineral density tests , provided prescriptions , and communicated with primary care physicians . The intervention was compared with usual care in a r and omized controlled trial . METHODS We recruited from all hospitals that participate in the Capital Health system ( Alberta , Canada ) , including patients 50 years or older who had sustained a hip fracture and excluding those who were receiving osteoporosis treatment or who lived in a long-term care facility . Primary outcome was bisphosphonate therapy 6 months after fracture ; secondary outcomes included bone mineral density testing , appropriate care ( bone mineral density testing and treatment if bone mass was low ) , and intervention costs . RESULTS We screened 2219 patients and allocated 220 , as follows : 110 to the intervention group and 110 to the control group . Median age was 74 years , 60 % were women , and 37 % reported having had previous fractures . Six months after hip fracture , 56 patients in the intervention group ( 51 % ) were receiving bisphosphonate therapy compared with 24 patients in the control group ( 22 % ) ( adjusted odds ratio , 4.7 ; 95 % confidence interval , 2.4 - 8.9 ; P Bone mineral density tests were performed in 88 patients in the intervention group ( 80 % ) vs 32 patients in the control group ( 29 % ) ( P bone mineral density testing , 25 ( 21 % ) had normal bone mass . Patients in the intervention group were more likely to receive appropriate care than were patients in the control group ( 67 % vs 26 % ; P intervention cost was $ 50.00 per patient . CONCLUSION For a modest cost , a case manager was able to substantially increase rates of osteoporosis treatment in a vulnerable elderly population at high risk of future fractures",
"This article reports a controlled trial to investigate the effectiveness of patient education and a physician alerting system in altering secondary osteoporosis prevention after a low-trauma ( fragility ) wrist fracture and to record the current rate of osteoporosis investigation following such fractures . Fifty-one women and men aged 50 years or older with a low-trauma wrist fracture were identified ( 41 women and 10 men ; mean age [ 95 % CI ] , 71.51 [ 67.31 - 74.81 ] ) . The intervention group received a four-part intervention aim ed at both the patient and the family physician in addition to the usual care for the fracture . The control group only received usual care for the fracture . Data were collected for both groups at six weeks and six months . Results indicate that 92 % of the intervention subjects were investigated for osteoporosis , compared with the usual-care group , in which only 23 % were investigated . Early osteoporosis intervention has the potential to limit disease impact , and h and therapists can play a key role in early identification of osteoporosis",
"OBJECTIVE To implement and evaluate a multimodal intervention to improve osteoporosis treatment in patients with a fragility fracture . DESIGN , SETTING AND PARTICIPANTS Strategies to improve the management of patients discharged from an emergency department after presentation with fragility fracture were implemented prospect ively in a large tertiary public hospital . Patients were surveyed by post to assess their awareness of osteoporosis and of the need for treatment . General practitioners and hospital clinicians completed an online question naire about their attitudes to osteoporosis and its management . A simplified consensus guideline was developed for local use . Our study was conducted between 1 October 2007 and 31 October 2008 . MAIN OUTCOME MEASURES Rates of referral of patients for osteoporosis review ; rates of investigation and treatment . RESULTS Although most GPs ( 259/306 [ 85 % ] ) accepted that it was their responsibility to assess and treat their patients and inform them of their osteoporosis risk , only 35/87 patients ( 40 % ) indicated awareness of their risk . After implementation of our project , the rate of bone mineral densitometry investigations improved from 6/200 ( 3 % ) to 39/87 ( 45 % ) ( P number of patients receiving calcium and vitamin D supplementation increased from 24/200 ( 12 % ) ( for both supplements ) to 29/87 ( 33 % ) and 32/87 ( 37 % ) , respectively ( P Initiation of specific treatments increased from 12/200 ( 6 % ) to 26/87 ( 30 % ) ( P Referral of eligible patients to the Fragile Bone Clinic for osteoporosis review improved from 20/500 ( 4 % ) to 51/194 ( 26 % ) . After being contacted by a fracture liaison nurse , 84 % of these patients presented for osteoporosis review in the clinic . CONCLUSIONS A major key to improving osteoporosis management is to actively identify all patients at risk and proactively engage and encourage them to seek assessment and management . A multimodal strategy involving a dedicated fracture liaison nurse may offer the greatest potential for improving education and patient follow-up and treatment",
"OBJECTIVE We previously demonstrated that a case manager intervention improved osteoporosis ( OP ) treatment within 6 months of hip fracture compared with usual care . The second phase of the r and omized trial compared a less intensive intervention , facilitated bone mineral density ( BMD ) testing , with usual care and the case manager intervention . METHODS We initially r and omized 220 hip fracture patients to either an OP case manager intervention or usual care . After completing the original trial at 6 months postfracture , usual care patients were reallocated to facilitated BMD testing ; BMD tests were arranged and results sent to primary care physicians . Main outcomes ( bisphosphonate treatment , BMD tests , receipt of appropriate care ) were reascertained 1 year following hip fracture and compared with outcomes achieved by the OP case manager intervention and usual care . RESULTS Compared with usual care , facilitated BMD testing increased testing from 29 % to 68 % ( P bisphosphonate use from 22 % to 38 % ( P of appropriate care from 26 % to 45 % ( P OP case manager intervention led to significantly higher bisphosphonate use ( 54 % versus 38 % ; P = 0.03 ) , receipt of appropriate care ( 71 % versus 45 % ; P BMD testing ( 80 % versus 68 % ; P = 0.06 ) than usual care followed by facilitated BMD testing . CONCLUSION Compared with usual care , 2 different inexpensive interventions result ed in significant increases in appropriate management of OP after hip fracture . The magnitude of improvements achieved was directly related to the intensity of the interventions"
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411806da-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Lactoferrin , a normal component of human colostrum and milk , can enhance host defenses and may be effective for prevention of sepsis and necrotizing enterocolitis ( NEC ) in preterm neonates . OBJECTIVES Primary objective 1 . To assess the safety and effectiveness of lactoferrin supplementation to enteral feeds for prevention of sepsis and NEC in preterm neonates Secondary objectives 1 . To determine the effects of lactoferrin supplementation to enteral feeds to prevent neonatal sepsis and /or NEC on duration of positive-pressure ventilation , development of chronic lung disease ( CLD ) or periventricular leukomalacia ( PVL ) , length of hospital stay to discharge among survivors , and adverse neurological outcomes at two years of age or later2 . To determine the adverse effects of lactoferrin supplementation for prophylaxis of neonatal sepsis and /or NECWhen data were available , we analyzed the following subgroups.1 . Gestational age . Type of feeding : breast milk versus formula milk SEARCH METHODS : We used the search strategy of the Cochrane Neonatal Review Group ( CNRG ) to up date our search in December 2016 . We search ed the data bases Cochrane Central Register of Controlled Trials ( CENTRAL ) , MEDLINE , PRE MEDLINE , Embase , and the Cumulative Index to Nursing and Allied Health Literature ( CINAHL ) , as well as trial registries and conference proceedings . SELECTION CRITERIA R and omized controlled trials ( RCTs ) evaluating oral lactoferrin at any dose or duration to prevent sepsis or NEC in preterm neonates . DATA COLLECTION AND ANALYSIS Review authors used st and ard methods of the CNRG . MAIN RESULTS This review includes six RCTs . Trial results show that lactoferrin supplementation to enteral feeds decreased late-onset sepsis ( typical risk ratio ( RR ) 0.59 , 95 % confidence interval ( CI ) 0.40 to 0.87 ; typical risk difference ( RD ) -0.06 , 95 % CI -0.10 to -0.02 ; number needed to treat for an additional beneficial outcome ( NNTB ) 17 , 95 % CI 10 to 50 ; six trials , 886 participants ; low- quality evidence ) and NEC stage II or III ( typical RR 0.40 , 95 % CI 0.18 to 0.86 ; typical RD -0.04 , 95 % CI -0.06 to -0.01 ; NNTB 25 , 95 % CI 17 to 100 ; four studies , 750 participants ; low- quality evidence ) . Lactoferrin supplementation did not have an effect on " all-cause mortality " ( typical RR 0.65 , 95 % CI 0.37 to 1.11 ; typical RD -0.02 , 95 % CI -0.05 to 0 ; six studies , 1041 participants ; low- quality evidence ) .Lactoferrin supplementation to enteral feeds with probiotics decreased late-onset sepsis ( RR 0.27 , 95 % CI 0.12 to 0.60 ; RD -0.13 , 95 % CI -0.19 to -0.06 ; NNTB 8 , 95 % CI 5 to 17 ; one study , 321 participants ; low- quality evidence ) and NEC stage II or III ( RR 0.04 , 95 % CI 0.00 to 0.62 ; RD -0.05 , 95 % CI -0.08 to -0.03 ; NNTB 20 , 95 % CI 12.5 to 33.3 ; one study , 496 participants ; low- quality evidence ) , but not " all-cause mortality " ( low- quality evidence ) .Lactoferrin supplementation to enteral feeds with or without probiotics decreased bacterial and fungal sepsis but not CLD or length of hospital stay ( low- quality evidence ) . Investigators reported no adverse effects and did not evaluate long-term neurological outcomes and PVL . AUTHORS ' CONCLUSIONS Evidence of low quality suggests that lactoferrin supplementation to enteral feeds with or without probiotics decreases late-onset sepsis and NEC stage II or III in preterm infants without adverse effects . Completed ongoing trials will provide data from more than 6000 preterm neonates , which may enhance the quality of the evidence . Clarification regarding optimal dosing regimens , types of lactoferrin ( human or bovine ) , and long-term outcomes is needed
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"OBJECTIVES To evaluate the efficacy of bovine lactoferrin ( BLF ) in preventing first episode of late-onset sepsis ( LOS ) in low birth weight ( LBW ) neonates . METHODS In this study conducted from May 2012 to July 2013 in the neonatal intensive care unit ( NICU ) of a tertiary care hospital , inborn asymptomatic neonates , to receive BLF or placebo from 1st to 28th day of life . The incidence of culture-proven sepsis and sepsis-attributable mortality after 72 h of life was recorded . Increasing doses of BLF were used with higher birth weights . RESULTS Incidence of first episode of culture-proven LOS was significantly lower in the BLF group vs. placebo [ 2/63 ( 3.2 % ) vs. 9/67(13.4 % ) ; risk ratio , 0.211 ; 95 % CI , 0.044 - 1.019 ; p = 0.036 ] . Statistically significant reduction in the sepsis-attributable mortality was also seen after use of prophylactic BLF [ 0/63 ( 0 % ) vs. 5/67 ( 7.5 % ) ; p = 0.027 ] . CONCLUSION BLF supplementation in LBW neonates reduced the incidence of first episode of LOS",
"Lactoferrin has broad-spectrum antimicrobial activity , and the authors hypothesized that recombinant human lactoferrin ( Talactoferrin alfa [ TLF ] ) would reduce mortality and morbidity in a coinfection model . The MIC50 ( minimum inhibitory concentration required to inhibit the growth of 50 % of organisms ) of TLF againstC and ida albicans and Staphylococcus epidermidis was determined . Neonatal Wistar rats were infected withCalbicans orS epidermidis or both , at doses of 2 × 108 colony-forming units ( CFUs ) given subcutaneously . Rat pups in each group were r and omly given TLF intraperitoneally at 40 mg/kg/dose or 300 mg/kg/dose , or saline in 0.2 mL , once a day for 4 d and were monitored for mortality , weight gain , and blood culture positivity . Trough serum levels of TLF were measured at 24 , 48 , 72 , 96 , and 144 h. MIC50 of TLF was 30 μg/mL and 500 μg/mL forC albicans and Sepidermidis , respectively . TLF prophylaxis significantly improved survival in the coinfection group at 40 mg/kg/dose ( by 16.1 % ; P=.019 ) and at 300 mg/kg/dose ( by 15.1 % ; P=.027 ) and in the Sepidermidis group at a dose of 40 mg/kg/dose ( by 1 8.6 % ; P=.04 ) . Weight gain was not affected by TLF prophylaxis . Serum trough levels of TLF were 1000-fold lower than in vitro MIC50 . The authors conclude that lactoferrin prophylaxis significantly enhanced survival in coinfection and in the subgroupof S epidermidis infection ( 40 mg/kg/dose ) through indirect mechanisms",
"Summary Background : Lactoferrin is an iron-binding glycoprotein first identified in breast milk as a protein product of mammary epithelial cells . Its immunomodulatory functions include activation of NK and lymphokine-activated killer cells and enhancement of PMN and macrophage cytotoxicity . Studies in animal models have shown promising anti-cancer activity . The purpose of the present study was to evaluate the safety and tolerability of talactoferrin alfa ( talactoferrin ; TLF ) in humans , as well as pharmacokinetics and pharmacodynamics . Methods : Ten adult patients with progressive advanced solid tumors who had failed conventional chemotherapy were administered oral TLF at doses from 1.5 to 9 g/day , using a 2 weeks on , 2 weeks off schedule . Patients were evaluated for drug toxicity , tumor growth rate , talactoferrin pharmacokinetics and cytokine markers . Results : Talactoferrin was very well tolerated . No hematological , hepatic , or renal toxicities were reported . A single patient had Grade 2 diarrhea , and there were no Grade 3 or 4 toxicities . Following oral administration , significant levels of talactoferrin were undetectable in circulation , but a statistically significant increase in circulating IL-18 , a pharmacodynamic indicator of talactoferrin activity , was observed . Of the eight patients who were radiologically evaluable , five ( 63 % ) had stable disease by RECIST criteria two months after start of therapy , including one patient with a minor response . Seven patients ( 88 % ) had a decrease in their tumor growth rate . The three patients with non-small cell lung cancer ( NSCLC ) all survived for at least one year following the start of talactoferrin monotherapy . Conclusions : Talactoferrin is a promising , well-tolerated new agent that should be evaluated further in patients with refractory metastatic cancer",
"CONTEXT Sepsis is a common and severe complication in premature neonates , particularly those with very low birth weight ( VLBW ) ( Whether lactoferrin , a mammalian milk glycoprotein involved in innate immune host defenses , can reduce the incidence of sepsis is unknown . In animal models , the probiotic Lactobacillus rhamnosus GG ( LGG ) enhances the activity of lactoferrin but has not been studied in human infants . OBJECTIVE To establish whether bovine lactoferrin ( BLF ) , alone or in combination with LGG , reduces the incidence of late-onset sepsis in VLBW neonates . DESIGN , SETTING , AND PATIENTS Prospect i ve , multicenter , double-blind , placebo-controlled , r and omized trial conducted in 11 Italian tertiary neonatal intensive care units . Patients were 472 VLBW infants enrolled from October 1 , 2007 , through July 31 , 2008 , and assessed until discharge for development of sepsis . INTERVENTION Infants were r and omly assigned to receive orally administered BLF ( 100 mg/d ) alone ( n = 153 ) , BLF plus LGG ( 6 x 10(9 ) colony-forming units/d ) ( n = 151 ) , or placebo ( n = 168 ) from birth until day 30 of life ( day 45 for neonates First episode of late-onset sepsis , ie , sepsis occurring more than 72 hours after birth with isolation of any pathogen from blood or from peritoneal or cerebrospinal fluid . RESULTS Demographic , clinical , and management characteristics of the 3 groups were similar , including type of feeding and intake of maternal milk . Incidence of late-onset sepsis was significantly lower in the BLF and BLF plus LGG groups ( 9/153 [ 5.9 % ] and 7/151 [ 4.6 % ] , respectively ) than in the control group receiving placebo ( 29/168 [ 17.3 % ] ) ( risk ratio , 0.34 ; 95 % confidence interval , 0.17 - 0.70 ; P = .002 for BLF vs control and risk ratio , 0.27 ; 95 % confidence interval , 0.12 - 0.60 ; P bacterial and fungal sepsis . No adverse effects or intolerances to treatment occurred . CONCLUSION Compared with placebo , BLF supplementation alone or in combination with LGG reduced the incidence of a first episode of late-onset sepsis in VLBW neonates . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N53107700",
"Background : Early onset neonatal sepsis ( EOS , occurring in the first 72 hours of life ) remains an important cause of illness and death among very low birth weight ( VLBW ) preterm infants . We previously reported a change in the distribution of pathogens associated with EOS from predominantly Gram-positive to primarily Gram-negative organisms . Objective : To compare rates of EOS and pathogens associated with infection among VLBW infants born at centers of the National Institute of Child Health and Human Development ( NICHD ) Neonatal Research Network during 3 time periods : 1991–1993 ; 1998–2000 ; and 2002–2003 . Study Design : Prospect ively collected data from the NICHD Neonatal Research Network VLBW registry were retrospectively review ed . Rates of blood culture confirmed EOS , selected maternal and infant variables and pathogens associated with infection were compared between 2002–2003 and 2 previously published cohorts . Results : During the past 13 years , overall rates of EOS have remained stable ( 15–19 per 1000 live births of infants 401–1500 g ) . More than one-half of early infections in the 2002–2003 cohort were caused by Gram-negative organisms ( 53 % ) , with Escherichia coli the most common organism ( 41 % ) . Rates of group B streptococcal infections remain low ( 1.8 per 1000 live births ) . Between 1991–1993 and 1998–2000 , there was a significant increase in rates of E. coli infections ; but in 2002–2003 , there was no significant change ( 7.0 per 1000 live births ) . Infants with EOS continue to be at significantly increased risk for death compared with uninfected infants . Conclusion : EOS remains an uncommon but important cause of morbidity and mortality among VLBW infants . Gram-negative organisms continue to be the predominant pathogens associated with EOS",
"Hepatitis C virus ( HCV ) is associated with the development of cirrhosis and hepatocellular carcinoma . We recently found that bovine lactoferrin , a milk protein belonging to the iron transporter family , effectively prevented HCV infection in cultured human hepatocytes ( PH5CH8 ) . We tested the hypothesis that lactoferrin inhibits HCV viremia in patients with chronic hepatitis C. Eleven patients with chronic hepatitis C received an 8‐week course of bovine lactoferrin ( 1.8 or 3.6 g/day ) . At the end of lactoferrin treatment , a decrease in serum alanine transaminase and HCV RNA concentrations was apparent in 3 ( 75 % ) of 4 patients with low pretreatment serum concentrations of HCV RNA . However , 7 patients with high pretreatment concentrations showed no significant changes in these indices . This pilot study suggests that lactoferrin is one potential c and i date as an anti‐HCV reagent that may be effective for the treatment of patients with chronic hepatitis",
"OBJECTIVE Late-onset sepsis ( occurring after 3 days of age ) is an important problem in very low birth weight ( VLBW ) infants . To determine the current incidence of late-onset sepsis , risk factors for disease , and the impact of late-onset sepsis on subsequent hospital course , we evaluated a cohort of 6956 VLBW ( 401 - 1500 g ) neonates admitted to the clinical centers of the National Institute of Child Health and Human Development Neonatal Research Network over a 2-year period ( 1998 - 2000 ) . METHODS The National Institute of Child Health and Human Development Neonatal Research Network maintains a prospect i ve registry of all VLBW neonates admitted to participating centers within 14 days of birth . Exp and ed infection surveillance was added in 1998 . RESULTS Of 6215 infants who survived beyond 3 days , 1313 ( 21 % ) had 1 or more episodes of blood culture-proven late-onset sepsis . The vast majority of infections ( 70 % ) were caused by Gram-positive organisms , with coagulase-negative staphylococci accounting for 48 % of infections . Rate of infection was inversely related to birth weight and gestational age . Complications of prematurity associated with an increased rate of late-onset sepsis included patent ductus arteriosus , prolonged ventilation , prolonged intravascular access , bronchopulmonary dysplasia , and necrotizing enterocolitis . Infants who developed late-onset sepsis had a significantly prolonged hospital stay ( mean length of stay : 79 vs 60 days ) . They were significantly more likely to die than those who were uninfected ( 18 % vs 7 % ) , especially if they were infected with Gram-negative organisms ( 36 % ) or fungi ( 32 % ) . CONCLUSIONS Late-onset sepsis remains an important risk factor for death among VLBW preterm infants and for prolonged hospital stay among VLBW survivors . Strategies to reduce late-onset sepsis and its medical , social , and economic toll need to be addressed urgently",
"CONTEXT Neonatal infections are frequent complications of extremely low-birth-weight ( ELBW ) infants receiving intensive care . OBJECTIVE To determine if neonatal infections in ELBW infants are associated with increased risks of adverse neurodevelopmental and growth sequelae in early childhood . DESIGN , SETTING , AND PARTICIPANTS Infants weighing 401 to 1000 g at birth ( born in 1993 - 2001 ) were enrolled in a prospect ively collected very low-birth-weight registry at academic medical centers participating in the National Institute of Child Health and Human Development Neonatal Research Network . Neurodevelopmental and growth outcomes were assessed at a comprehensive follow-up visit at 18 to 22 months of corrected gestational age and compared by infection group . Eighty percent of survivors completed the follow-up visit and 6093 infants were studied . Registry data were used to classify infants by type of infection : uninfected ( n = 2161 ) , clinical infection alone ( n = 1538 ) , sepsis ( n = 1922 ) , sepsis and necrotizing enterocolitis ( n = 279 ) , or meningitis with or without sepsis ( n = 193 ) . MAIN OUTCOME MEASURES Cognitive and neuromotor development , neurologic status , vision and hearing , and growth ( weight , length , and head circumference ) were assessed at follow-up . RESULTS The majority of ELBW survivors ( 65 % ) had at least 1 infection during their hospitalization after birth . Compared with uninfected infants , those in each of the 4 infection groups were significantly more likely to have adverse neurodevelopmental outcomes at follow-up , including cerebral palsy ( range of significant odds ratios [ ORs ] , 1.4 - 1.7 ) , low Bayley Scales of Infant Development II scores on the mental development index ( ORs , 1.3 - 1.6 ) and psychomotor development index ( ORs , 1.5 - 2.4 ) , and vision impairment ( ORs , 1.3 - 2.2 ) . Infection in the neonatal period was also associated with impaired head growth , a known predictor of poor neurodevelopmental outcome . CONCLUSIONS This large cohort study suggests that neonatal infections among ELBW infants are associated with poor neurodevelopmental and growth outcomes in early childhood . Additional studies are needed to eluci date the pathogenesis of brain injury in infants with infection so that novel interventions to improve these outcomes can be explored",
"Background : Lactoferrin is a mammalian milk glycoprotein involved in innate immunity . Recent data show that bovine lactoferrin ( bLF ) prevents late-onset sepsis in preterm very low birth weight ( VLBW ) neonates . Methods : This is a secondary analysis of data from a multicenter r and omized controlled trial where preterm VLBW neonates r and omly received bLF ( 100 mg/day ; group A1 ) , bLF + Lactobacillus rhamnosus GG ( 106 colony-forming units per day ; group A2 ) , or placebo ( group B ) for 6 weeks . Here we analyze the incidence rates of fungal colonization , invasive fungal infection ( IFI ) , and rate of progression from colonization to infection in all groups . Results : This study included 472 neonates whose clinical , nutritional , and demographical characteristics were similar . Overall , the incidence of fungal colonization was comparable ( 17.6 % , 16.6 % , and 18.5 % in A1 , A2 , and B , respectively ; P = .89 [ A1 ] and .77 [ A2 ] ) . In contrast , IFIs were significantly decreased in A1 and A2 ( 0.7 % and 2.0 % , respectively ) compared with B ( 7.7 % ; P = .002 [ A1 ] and .02 [ A2 ] ) , and this was significantly true both in progression rate colonization-infection was significantly lower in the bLF groups : 3.7 % ( A1 ) and 12 % ( A2 ) , vs 41.9 % ; P IFI-attributable deaths occurred in the treatment groups , versus 2 in placebo . No adverse effects or intolerances occurred . Conclusions : Prophylactic oral administration of bLF reduces the incidence of IFI in preterm VLBW neonates . No effect is seen on colonization . The protective effect on IFI is likely due to limitation of ability of fungal colonies to progress toward invasion and systemic disease in colonized infants",
"OBJECTIVE Lactoferrin ( LF ) is effective in the prevention of sepsis in very low birth weight ( VLBW ) neonates . T-regulatory cells ( Tregs ) are important subsets of T lymphocytes that control pathogen-specific immune responses and are essential for intestinal immune homoeostasis . The aim of the present study is to determine whether oral LF at a dosage of 200 mg/d reduces nosocomial sepsis episodes and necrotizing enterocolitis ( NEC ) in premature infants and to evaluate the possible effects of LF on Treg levels . STUDY DESIGN In this prospect i ve , placebo-controlled , double-blind , r and omized trial , infants either VLBW or born before 32 weeks were assigned to receive either placebo ( n = 25 ) , or 200 mg LF ( n = 25 ) daily throughout hospitalization . Episodes of culture proven nosocomial sepsis and NEC were recorded . The level of FOXP3 + CD4 + CD25hi lymphocytes was studied by flow cytometry at birth and discharge . A third comparison was made with healthy term neonates ( n = 16 ) . RESULTS Fewer sepsis episodes were observed in LF-treated infants ( 4.4 vs. 17.3/1,000 patient days , p = 0.007 ) with none developing NEC , without statistical significance . Treg levels at birth and discharge were similar , while preterm infants showed significantly lower levels than term controls . However , individual increases in Treg levels were higher in the LF group . CONCLUSION LF prophylaxis reduced nosocomial sepsis episodes . Treg levels in preterm infants were lower than in term infants and an increase of Treg levels under LF prophylaxis was observed . Increase in Treg levels can be the mechanism for protective effects of LF on nosocomial sepsis",
"OBJECTIVE To determine the effect of bovine lactoferrin ( bLF ) on prevention of diarrhea in children . STUDY DESIGN We conducted a community-based r and omized double-blind placebo controlled trial comparing supplementation with bLF vs placebo . Previously weaned children were enrolled at 12 - 18 months and followed for 6 months with daily home visits for data collection and supplement administration . Anthropometric measures were done monthly . RESULTS Five hundred fifty-five children were r and omized : 277 to bLF and 278 to placebo ; 65 dropped out ; 147 894 doses were administered ( 92 % compliance ) . Overall there were 91 446 child-days of observation and 1235 diarrhea episodes lasting 6219 days . The main pathogens isolated during diarrheal episodes were norovirus ( 35.0 % ) , enteropathogenic E coli ( 11.4 % ) , Campylobacter ( 10.6 % ) , enteroaggregative E coli ( 8.4 % ) , enterotoxigenic E coli ( 6.9 % ) , and Shigella ( 6.6 % ) . The diarrhea incidence was not different between groups : 5.4 vs 5.2 episodes/child/year for bLF and placebo , respectively ( P = .375 ) . However , the diarrhea longitudinal prevalence was lower in the bLF group vs placebo ( 6.6 % vs 7.0 % , P = .017 ) , as well as the median duration of episodes ( 4.8 vs 5.3 days , P = .046 ) , proportion of episodes with moderate or severe dehydration ( 1.0 % vs 2.6 % , P = .045 ) , and liquid stools load ( 95.0 vs 98.6 ) liquid stools/child/year , P events related to the intervention . CONCLUSIONS Although there was no decrease in diarrhea incidence , longitudinal prevalence and severity were decreased with LF",
"BACKGROUND Preterm infants remain at high risk of adverse outcomes following necrotizing enterocolitis ( NEC ) and late onset sepsis ( LOS ) . Meta- analysis of r and omized trials has indicated a reduction in severe NEC following use of probiotics and bovine lactoferrin ( LF ) . Overall , however , uncertainty remains over which probiotic , or combination to use . The aim of this study was to compare the incidence of severe NEC and LOS before and after routine supplementation with Lactobacillus GG ( LGG ) and LF . METHODS In this retrospective cohort study , infants LGG and 100 mg lactoferrin daily from 2011 -2015 were compared with similar infants born from 2004 - 2008 . Cases of NEC were Bell stage 2 or greater and LOS was blood or spinal fluid culture positive after 48 hrs of age . RESULTS We noted a marked decline in the incidence of NEC from 3 % to 1 % with a RR of 0.29 ( CI 0.1 - 0.9 ) and a number needed to benefit of 50 . The cost of preventing one case of NEC was estimated to be NZ $ 2800 , considerably lower than the cost of treatment . LOS rates were not significantly different . There was a decrease in retinopathy treatment rates . During the period there was one case of LGG sepsis in a 23 week gestation infant with abdominal pathology and one infant developed NEC after stopping prophylaxis . CONCLUSION The rates of severe NEC was markedly reduced following prophylaxis . The case of LGG sepsis indicates caution is required in extremely preterm infants",
"Objective : To determine tolerability of bovine lactoferrin ( bLF ) in very preterm infants , and whether the intervention can be adequately masked . Study Design : In a single-center masked pilot trial infants under 31 weeks gestation were r and omized before 48 h of age to receive milk with 100 mg per day of bLF or control . The primary outcome was feeding tolerance , defined as time to achieve full feeds ( 140 ml kg−1 per day ) . Parents answered a short question naire regarding acceptability of the intervention . Results : Seventy-nine infants were enrolled and analyzed according to intention to treat . There was no effect of bLF on the primary outcome . In addition , mortality , late onset sepsis and other complications of prematurity were no different . Equal numbers of parents in both groups believed their infant received bLF . Conclusion : We demonstrated that bLF is well tolerated , easy to administer and its presence in prepared milk is not evident . Trial registration number IS RCT N66482337",
"IMPORTANCE NEC is a common and severe complication in premature neonates , particularly those with very-low-birth-weight ( VLBW , Probiotics including lactobacillus rhamnosus GG ( LGG ) proved effective in preventing NEC in preterm infants in several RCTs . OBJECTIVE Lactoferrin , a mammalian milk glycoprotein involved in innate immune host defences , can reduce the incidence of NEC in animal models , and its action is enhanced by LGG . We tried to assess whether bovine lactoferrin ( BLF ) , alone or with the probiotic LGG , has a similar effect in human infants , something that has not yet been studied . DESIGN An international , multicenter , r and omized , double-blind , placebo-controlled trial conducted from October 1st , 2007 through July 31st , 2010 . SETTING Thirteen Italian and New Zeal and tertiary neonatal intensive care units . PARTICIPANTS 743 VLBW neonates were assessed until discharge for development of NEC . INTERVENTION Infants were r and omly assigned to receive orally either BLF ( 100 mg/day ) alone ( group LF ; n = 247 ) or with LGG ( at 6 × 10(9 ) CFU/day ; group BLF + LGG ; n = 238 ) , or placebo ( Control group ; n = 258 ) from birth until day 30 of life ( 45 for neonates ≥ stage 2 NEC ; death- and /or-≥ stage 2 NEC prior to discharge . RESULTS Demographics , clinical and management characteristics of the 3 groups were similar , including type of feeding and maternal milk intakes . NEC incidence was significantly lower in groups BLF and BLF + LGG [ 5/247 ( 2.0 % ) ] and 0/238 ( 0 % ) , respectively ] than in controls [ 14/258 ( 5.4 % ) ] ( RR = 0.37 ; 95 % CI : 0.136 - 1.005 ; p = 0.055 for BLF vs. control ; RR = 0.00 ; p control ) . The incidence of death- and /or-NEC was significantly lower in both treatment groups ( 4.0 % and 3.8 % in BLF and BLF + LGG vs. 10.1 % in control ; RR = 0.39 ; 95 % CI : 0.19 - 0.80 ; p = 0.008 . RR = 0.37 ; 95 % CI : 0.18 - 0.77 ; p = 0.006 , respectively ) . No adverse effects or intolerances to treatment occurred . CONCLUSIONS AND RELEVANCE Compared with placebo , BLF supplementation alone or in combination with LGG reduced the incidence of ≥ stage 2 NEC and of death- and /or ≥ stage 2 NEC in VLBW neonates . BLF might be a promising strategy to prevent NEC in NICU setting s. Further data on larger sample sizes are warranted before BLF can be widespreadly used in clinical setting s. TRIAL REGISTRATION IS RCT N53107700-http://www.controlled-_trials.com/IS RCT N53107700",
"The National Institute of Child Health and Human Development conducts and supports research on all stages of human development from preconception to adulthood in order to better underst and the health of children , youths , adults , families , and communities . Health and human development information is made easily available on the site with a simple A to Z list , along with clinical trials and health education campaign information . Links to clinical trials , news releases , publications , and related web sites are also available , as well as information on research being conducted at present and supported by the National Institute of Child Health and Human Development",
"Background : Lactoferrin ( LF ) is a broad-spectrum antimicrobial and immunomodulatory milk glycoprotein . Objective : To determine the effect of bovine LF on the prevention of the first episode of late-onset sepsis in Peruvian infants . Methods : We conducted a pilot r and omized placebo-controlled double blind study in infants with a birth weight ( BW ) less than 2500 g in 3 Neonatal Units in Lima . Patients were r and omized to receive bovine LF 200mg/kg/d or placebo for 4 weeks . Results : One hundred and ninety neonates with a BW of 1591 ± 408 g and a gestational age of 32.1 ± 2.6 weeks were enrolled . Overall , 33 clinical ly defined first late-onset sepsis events occurred . The cumulative sepsis incidence in the LF group was 12/95 ( 12.6 % ) versus 21/95 ( 22.1 % ) in the placebo group , and 20 % ( 8/40 ) versus 37.5 % ( 15/40 ) for infants less than or equal to 1500 g. The hazard ratio of LF , after adjustment by BW , was 0.507 ( 95 % CI : 0.249–1.034 ) . There were 4 episodes of culture-proven sepsis in the LF group versus 4 in the placebo group . Considering that children did not received the intervention until the start of oral or tube feeding , we ran a secondary exploratory analysis using time since the start of the treatment ; in this model , LF achieved significance . There were no serious adverse events attributable to the intervention . Conclusions : Overall sepsis occurred less frequently in the LF group than in the control group . Although the primary outcome did not reach statistical significance , the confidence interval is suggestive of an effect that justifies a larger trial",
"OBJECTIVE To evaluate the safety and explore the efficacy of recombinant human lactoferrin ( talactoferrin [ TLf ] ) to reduce infection . STUDY DESIGN We conducted a r and omized , double blind , placebo-controlled trial in infants with birth weight of 750 - 1500 g. Infants received enteral TLf ( n = 60 ) or placebo ( n = 60 ) on days 1 through 28 of life ; the TLf dose was 150 mg/kg every 12 hours . Primary outcomes were bacteremia , pneumonia , urinary tract infection , meningitis , and necrotizing enterocolitis ( NEC ) . Secondary outcomes were sepsis syndrome and suspected NEC . We recorded clinical , laboratory , and radiologic findings , along with diseases and adverse events , in a data base used for statistical analyses . RESULTS Demographic data were similar in the 2 groups of infants . We attributed no enteral or organ-specific adverse events to TLf . There were 2 deaths in the TLf group ( 1 each due to posterior fossa hemorrhage and postdischarge sudden infant death ) , and 1 death in the placebo group , due to NEC . The rate of hospital-acquired infections was 50 % lower in the TLf group compared with the placebo group ( P blood or line infections , urinary tract infections , and pneumonia . Fourteen infants in the TLf group weighing had no gram-negative infections , compared with only 3 of 14 such infants in the placebo group . Noninfectious outcomes were not statistically significantly different between the 2 groups , and there were no between-group differences in growth or neurodevelopment over a 1-year posthospitalization period . CONCLUSION We found no clinical or laboratory toxicity and a trend toward less infectious morbidity in the infants treated with TLf . TRIAL REGISTRATION Clinical Trials.gov : NCT00854633",
"Background : Lactoferrin has an array of biological activities that include growth , immune modulation , and antimicrobial effects . The aim of this r and omized , placebo-controlled , double-blind study was to examine the impact of bovine lactoferrin supplementation in infants . Patients and Methods : Healthy , formula-fed infants , ≥34 weeks ' gestation and ≤4 weeks of age , enrolled in a pediatric clinic . Infants received either formula supplemented with lactoferrin ( 850 mg/L ) or commercial cow milk – based formula ( 102 mg/L ) for 12 months . Growth parameters and information on gastrointestinal , respiratory , and colic illnesses were collected for the infants ' first year . Antibodies to immunizations and hematologic parameters were measured at 9 and 12 months . Results : The lactoferrin-enhanced formula was well tolerated . There were significantly fewer lower respiratory tract illnesses , primarily wheezing , in the 26 lactoferrin-fed ( 0.15 episodes/y ) compared with the 26 regular formula-fed ( 0.5 episodes/y ) infants ( P Significantly higher hematocrit levels at 9 months ( 37.1 % vs 35.4 % ; P Conclusions : Lactoferrin supplementation was associated with potentially beneficial outcomes such as significantly fewer lower respiratory tract illnesses and higher hematocrits . Larger , more focused studies in infants are warranted"
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4118075c-06ff-11f0-808a-c43d1ab1c353
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The importance of vitamin D for musculoskeletal health has long been recognized , and awareness of significant extra-skeletal effects in health and disease is rapidly emerging . Although it has been possible for many decades to quantify serum markers of vitamin D deficiency , and to correct deficiency at low cost and with high safety , the influence of vitamin D status on post-surgical outcomes has only recently been identified as a research topic of interest . To the present , these data have not been the subject matter of formal review . Accordingly , we conducted a systematic review to assess the association between perioperative vitamin D status and outcomes after surgery . The data bases of PubMed , Ovid MEDLINE , EMBASE , AMED , CINAHL ( EBSCOHost ) , The Cochrane Data bases of Systematic Review , and PROSPERO were search ed through December , 2014 for studies relating to vitamin D and surgery . The initial search yielded 90 manuscripts . After applying exclusion criteria , 31 studies were eligible for inclusion . Fifteen studies employed prospect i ve observational design s , 3 used prospect i ve r and omized protocol s , and 13 report retrospective data base interrogations . The main finding of the present review is that 26 of 31 studies ( 84 % ) report at least one statistically significant worse outcome in patients with low vitamin D status . Five of 31 studies ( 16 % ) found no association . In conclusion , this review supports the hypothesis that hypovitaminosis D is associated with adverse outcomes after diverse surgical procedures . Future studies should focus on additional surgeries and outcomes , and on the role of vitamin D supplementation in the improvement of patient safety in participants with low vitamin D status at the time of surgery
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"We prospect ively measured functional performances ( Western Ontario and McMaster Universities Osteoarthritis Index , Short Form-36 , 2-minute walk test , and timed get-up- and -go test ) of patients who underwent total hip arthroplasty ( THA ) and had serum vitamin D levels tested during the preoperative evaluation . Of 219 patients , 102 ( 46.6 % ) had low vitamin D levels ( 25-hydroxyvitamin D vitamin D status did not adversely affect short-term function at 6 weeks after THA . In addition , there was no association between serum vitamin D levels and the within-patient changes of scores of each outcome measurement . Because this 6-week period is generally adequate to correct vitamin D deficiency , orthopedic surgeons can safely perform THA without delay . Nevertheless , because vitamin D deficiency impairs bone quality , patients with low vitamin D levels should be treated once identified",
"Prospect i ve epidemiologic studies generally rely on 1 baseline biologic sample from participants for measurement of prediagnostic biomarkers , assuming that 1 measurement adequately represents the participant 's \" typical \" level . The body of work assessing the reproducibility of circulating serum 25-hydroxyvitamin D ( 25(OH)D ) levels over time focuses almost exclusively on population s of European descent , and data for vitamin D-binding protein ( VDBP ) are virtually nonexistent . Thus , the authors measured levels of serum 25(OH)D and VDBP twice in sample s collected between 2005 and 2008 from 225 participants ( 155 black , 70 white ) in the Southern Community Cohort Study . Reproducibility for 25(OH)D was uniformly high , with adjusted intraclass correlation coefficients ( ICCs ) of 0.84 ( 95 % confidence interval ( CI ) : 0.79 , 0.88 ) for blacks and 0.92 ( 95 % CI : 0.87 , 0.95 ) for whites , and there was substantial agreement for assignment of 25(OH)D quartile ( κ = 0.83 , 95 % CI : 0.78 , 0.87 ) and vitamin D adequacy status ( κ = 0.76 , 95 % CI : 0.69 , 0.83 ) . VDBP levels were highly stable over time , with adjusted ICCs of 0.97 ( 95 % CI : 0.96 , 0.98 ) for blacks and 0.96 ( 95 % CI : 0.93 , 0.97 ) for whites . These findings suggest that single , baseline 25(OH)D and VDBP serum measurements provide reasonably representative measures of these compounds for both white and black adults , demonstrating their utility as epidemiologic biomarkers in prospect i ve studies",
"AIMS A significant proportion of cardiac surgical patients develop critical post-operative complications . We aim ed to investigate the association of pre-operative 25-hydroxyvitamin D ( 25(OH)D ) levels with major cardiac and cerebrovascular events ( MACCE ) in cardiac surgical patients . METHODS AND RESULTS From January 2010 to August 2011 , we consecutively measured circulating 25(OH)D in 4418 operated patients . Of the study cohort , 38.0 % had deficient 25(OH)D values ( 100 nmol/L. The incidence of MACCE was 11.5 % . In multivariable-adjusted logistic regression models , the odds ratio of MACCE at deficient , inadequate , and high 25(OH)D levels was 2.23 [ 95 % confidence interval ( CI ) : 1.31 - 3.79 ] , 1.73 ( 95 % CI : 1.01 - 2.96 ) and 2.34 ( 95 % CI : 1.12 - 4.89 ) , respectively , compared with 25(OH)D levels of 75 - 100 nmol/L. A U-shaped association with circulating 25(OH)D was also present for duration of mechanical ventilatory support and intensive care unit stay . Multivariable-adjusted 6- and 12-month mortality were higher in patients with deficient 25(OH)D levels compared with patients with 25(OH)D levels of 75 - 100 nmol/L. CONCLUSION Deficient 25(OH)D levels are prevalent in cardiac surgical patients in Central Europe and are independently associated with the risk of MACCE . Further research should clarify the potential of vitamin D supplements in reducing cardiovascular risk in vitamin D-deficient patients and also the mechanisms leading to adverse effects on the cardiovascular system in the small group of patients with 25(OH)D levels > 100",
"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 Hypovitaminosis D is particularly common among older people with a proximal femoral ( hip ) fracture . There are currently no agreed strategies for vitamin D replenishment after hip fracture surgery . The REVITAHIP Study is a multisite , double-blinded r and omized-controlled trial investigating the effects of an oral vitamin D loading dose on gait velocity after hip fracture surgery . We describe the baseline characteristics of participants , aim ing to document hypovitaminosis D and its associations after hip fracture . Methods Participants , over 65 , recruited within 7 days following hip fracture surgery from 3 Australia hospitals , were r and omly allocated to receive a loading dose of vitamin D3 ( 250,000IU ) or placebo , followed by oral maintenance vitamin D3/calcium ( 800 IU/500 mg ) and the usual hip fracture rehabilitation pathway . Demographic and clinical data were collected , including surgical procedure , pre-fracture functional status , Mini Mental State Examination ( MMSE ) score , serum 25-hydroxyvitamin D ( 25-OHD ) , Verbal Rating Scale ( VRS ) for pain , grip strength and gait velocity . The associations of baseline 25-OHD levels with demographic and clinical data were assessed using Pearson ’s correlation , ANOVA and regression analyses . Results Two-hundred- and -eighteen people with hip fracture participated in the study . Mean age was 83.9+/-7.2 years , 77 % were women and 82 % lived in private homes . Fifty-six percent had a subcapital fracture . Mean comorbidity count was 3.13+/-2.0 . Mean MMSE was 26.1+/-3.9 . Forty-seven percent of participants had hypovitaminosis D ( vitamin D levels were significantly associated with higher premorbid Barthel index scores , lower post-operative VRS pain levels and use of vitamin D. Conclusion This study cohort shared similar demographic characteristics and comorbidities with other cohorts of people with hip fracture , with the probable exception of less cognitive impairment . Hypovitaminosis D was not as prevalent as previously documented . Patients taking vitamin D supplements and with higher premorbid Barthel index , reflecting greater independence and activity , tended to have higher 25-OHD levels at baseline . Further , lower VRS pain ratings following surgery were associated with higher vitamin D levels . Such associations will need further investigation to determine causation . ( ANZCTR number , ACTRN12610000392066).Trial registration The protocol for this study is registered with the Australian New Zeal and Clinical Trials Registry ANZCTRN ACTRN12610000392066",
"Background . Administration of the vitamin D hormone calcitriol improves survival in solid-organ transplanted experimental animals . We investigated whether lower serum calcitriol concentrations are associated with increased 1-year mortality in cardiac transplant recipients . Methods . We prospect ively recruited 171 patients who underwent cardiac transplantation at out institution between May 2004 and April 2006 . We assessed calciotropic hormones , inflammation markers , and renal function preoperatively and on postoperative days 6 ( t1 ) and 21 ( t2 ) . Results . Serum creatinine and C-reactive protein increased , whereas calcitriol decreased significantly after transplantation ( P of 1-year mortality . One-year mortality was 3.7 per 100 person-years in the tertile with the highest calcitriol concentrations at t2 ( > 18 pg/mL ) , 13.2 per 100 person-years in the intermediate tertile ( 11–18 pg/mL ) , and 32.1 per 100 person-years in the tertile with the lowest calcitriol concentrations at t2 ( 25-hydroxyvitamin D deficiency ( serum concentrations below 10 ng/mL ) , renal insufficiency ( serum creatinine ≥1.6 mg/dL ) , and high serum concentrations of the inflammation markers C-reactive peptide and tumor necrosis factor-&agr ; were predictors of a serum calcitriol concentration below 11 pg/mL ( P=0.037–0.001 ) . Conclusions . Low postoperative calcitriol concentrations are independently associated with high 1-year mortality in cardiac transplant recipients . A causal relationship has yet to be proven by intervention trials using active vitamin",
"Objective : To investigate the interrelationship between cardiac surgery , age , circulating concentrations of the vitamin D hormone 1,25-dihydroxyvitamin D , and clinical outcome . Design : Prospect i ve , monocentric , two-arm parallel study . Setting : Tertiary Heart and Diabetes Center in the Federal State of North Rhine-Westphalia , Germany . Patients : Twenty-nine cardiac surgical patients aged ⩽65 yrs and 30 patients ≥75 yrs . Measurements : We assessed 1,25-dihydroxyvitamin D and other biochemical parameters of mineral metabolism ( calcium , phosphate , 25-hydroxyvitamin D , and parathyroid hormone ) , various inflammatory markers ( C-reactive protein , interleukin-6 and 8) , and different immunological parameters ( CD4 and CD8 cells , monocyte HLA-DR expression ) . We collected blood sample s preoperatively , immediately after surgery , and on postoperative days 1 , 5 , and 30 . In addition , we assessed adverse outcome until discharge as a composite of myocardial infa rct ion , low cardiac output syndrome , infection , stroke , or in-hospital death . Results : There were significant transient cardiac surgery-related fluctuations in 1,25-dihydroxyvitamin D and the aforementioned parameters of mineral metabolism , inflammation , and immune status . Compared to younger patients , older patients had consistently lower 1,25-dihydroxyvitamin D and phosphate levels ( p = .013 and p = .036 , respectively ) and significantly higher interleukin 6 and 8 levels ( p = .008 and p . Circulating 1,25-dihydroxyvitamin D was directly related to glomerular filtration rate ( R2 = .227 ; p to interleukin 6 ( R2 = .105 ; p = .012 ) . The rate of adverse outcome tended to be higher in older than in younger patients ( 20.0 % vs. 3.5 % ; p = .081 ) . In risk score-adjusted logistic regression analysis , adverse outcome risk decreased by 7.7 % ( SE : 3.7 % ) for each pmol/L increment in 1,25-dihydroxyvitamin D ( p = .037 ) . Conclusions : Circulating 1,25-dihydroxyvitamin D levels fluctuate in relation to cardiac surgery . Low 1,25-dihydroxyvitamin D levels are associated with inflammatory processes and age-related differences in clinical outcome . Future studies should determine whether therapies aim ed at treating low 1,25-dihydroxyvitamin D levels can improve the outcome in older cardiac surgery patients",
"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 : Vitamin D deficiency is a global health problem . Epidemiological studies demonstrate that vitamin D is both cardioprotective and neuroprotective . Vitamin D also plays a substantial role in innate and acquired immunity . Our goal was to evaluate the association of serum vitamin D concentration on serious postoperative complications and death in noncardiac surgical patients . METHODS : We retrospectively analyzed the data of 3509 patients who had noncardiac surgery at the Clevel and Clinic Main Campus and had a serum vitamin D measurement . The relationship between serum vitamin D concentration and all-cause in-hospital mortality , in-hospital cardiovascular morbidity , and serious in-hospital infections was assessed as a common effect odds ratio ( OR ) by using a multivariate generalized estimating equation model with adjustment for demographic , medical history variables , and type and duration of surgery . RESULTS : Higher vitamin D concentrations were associated with decreased odds of in-hospital mortality/morbidity ( P = 0.003 ) . There was a linear reduction of the corresponding common effect odds ratio ( OR 0.93 , 95 % confidence interval , 0.88–0.97 ) for severe in-hospital outcomes for each 5 ng/mL increase in vitamin D concentration over the range from 4 to 44 ng/mL. In addition , we found that the odds versus patients with vitamin D ( i.e. , 1st quintile ) were significantly lower in patients with vitamin D 13–20 , 20–27 , 27–36 , and > 36 ng/mL ( i.e. , 2nd–5th quintiles ) ; the corresponding estimated ORs were 0.65 ( 99 % confidence interval , 0.43–0.98 ) , 0.53 ( 0.35–0.80 ) , 0.44 ( 0.28–0.70 ) , and 0.49 ( 0.31–0.78 ) , respectively . However , there was no statistically significant difference among individual quintiles > 13 ng/mL. CONCLUSIONS : Vitamin D concentrations were associated with a composite of in-hospital death , serious infections , and serious cardiovascular events in patients recovering from noncardiac surgery . While causality can not be determined from our retrospective analysis , the association suggests that a large r and omized trial of preoperative vitamin D supplementation and postoperative outcomes is warranted",
"Study Design . A prospect i ve cohort study . Objective . To demonstrate the changes in vitamin D status after surgery in female patients with lumbar spinal stenosis ( LSS ) , and its correlation with surgical outcomes . Summary of Background Data . In patients with LSS , general health including walking ability and nutritional status can be markedly improved by decompressive surgery . It can be hypothesized that such improvement may have a positive effect on their vitamin D status . Methods . In total , 31 female patients who underwent decompression and instrumented posterolateral fusion for LSS were enrolled . Serum 25-hydroxyvitamin D ( 25-OHD ) level was measured before the surgery and at 1 year postoperative visit . According to serum 25-OHD level , patients were classified into 3 groups : ( 1 ) deficient group , when 25-OHD level was less than 20 ng/mL ( ) . The Oswestry Disability Index ( ODI ) score and health-related quality of life ( EQ-5D ) were compared according to the level of 25-OHD at 1 year postoperatively . Results . Preoperatively , there were 20 patients in the deficient group , 11 patients in the insufficient group and no patient in the normal group . There were no differences in age , body mass index , preoperative ODI scores , preoperative EQ-5D index scores , and EQ-5D visual analogue scale scores between the 2 groups . Mean preoperative 25-OHD level was 15.8 ng/mL ( range , 5.2–29.4 ng/mL ) and increased to 19.5 ng/mL ( range , 6.3–47.7 ng/mL ) 1 year after surgery ( P = 0.075 ) . Significant increase of 25-OHD was noted only in the deficient group ( P = 0.017 ) . Postoperatively , there were 18 patients in the deficient group , 8 patients in the insufficient group , and 5 patients in the normal group . In the postoperative deficient group , postoperative ODI scores and EQ-5D index scores showed significantly worse outcomes than those in the other groups . The changes in serum 25-OHD level were significantly correlated with the changes in ODI scores ( r = −0.580 ; P = 0.001 ) and with the changes in EQ-5D index scores ( r = 0.379 ; P = 0.035 ) . In all the groups , postoperative ODI scores ( r = −0.665 ; P and EQ-5D index scores ( r = 0.601 ; P Vitamin D deficiency was common in patients with LSS . However , vitamin D status was improved after decompressive surgery , and postoperative 25-OHD level was significantly correlated with surgical outcomes",
"IMPORTANCE Postoperative hospital-acquired infections ( HAIs ) may result from disruption of natural barrier sites . Recent studies have linked vitamin D status and barrier site integrity . OBJECTIVE To investigate the association between preoperative vitamin D status and the risk for HAIs . DESIGN , SETTING , AND PARTICIPANTS A retrospective analysis was performed using propensity score methods to construct a matched-pairs cohort to reduce baseline differences between patients with 25-hydroxyvitamin D ( 25[OH]D ) levels less than 30 ng/mL vs 30 ng/mL or greater . Multivariable logistic regression analysis was then performed to examine the association between 25(OH)D levels and HAIs while adjusting for additional perioperative factors . Locally weighted scatterplot smoothing was used to depict the relationship between increasing 25(OH)D levels and the risk for HAIs . This study was conducted in a single , teaching hospital in Boston , Massachusetts , and involved 770 gastric bypass surgery patients between January 1 , 2007 , and December 31 , 2011 . EXPOSURES Preoperative 25(OH)D levels . MAIN OUTCOMES AND MEASURES Association between preoperative 25(OH)D levels and the risk for postoperative HAIs . RESULTS The risk for HAIs was 3-fold greater ( adjusted odds ratio , 3.05 ; 95 % CI , 1.34 - 6.94 ) in patients with 25(OH)D levels less than 30 ng/mL vs 30 ng/mL or greater . Further adjustment for additional perioperative factors did not material ly change this association . Locally weighted scatterplot smoothing analysis depicted a near inverse linear relationship between vitamin D status and the risk for HAIs for 25(OH)D levels around 30 ng/mL. CONCLUSIONS AND RELEVANCE In our patient cohort , a significant inverse association was observed between preoperative 25(OH)D levels and the risk for HAIs . These results suggest that preoperative 25(OH)D levels may be a modifiable risk factor for postoperative nosocomial infections . Prospect i ve studies must determine whether there is a potential benefit to preoperative optimization of vitamin D status",
"Background : Vitamin D is recognized as a pleiotropic hormone important for the functioning of organ systems , including those central to critical illness pathophysiology . Recent studies have reported associations between vitamin D status and outcome among critically ill adults and children . Preoperative vitamin D status , impact of operative techniques , and relationship between immediate postoperative vitamin D levels and clinical course have not been described in the pediatric congenital heart disease ( CHD ) population . The objective of this study was to describe the impact of CHD surgery on vitamin D status and relationship between postoperative levels and clinical course . Methods : A prospect i ve cohort study was conducted from 2009 to 2011 at a single tertiary care pediatric hospital . A total of 58 children with CHD were enrolled and blood collected preoperatively , intraoperatively , and postoperatively . Serum 25-hydroxyvitamin D ( 25OHD ) was measured using liquid chromatography – mass spectrometry . Results : The mean preoperative 25OHD was 58.0 nM ( SD , 22.4 ) , with 42 % being deficient ( 25OHD to 34.2 nM ( SD , 14.5 ) with 86 % being deficient . Intraoperative measurements determined that initiation of cardiopulmonary bypass coincided with abrupt decline . CHD patients requiring catecholamines had lower postoperative 25OHD ( 38.2 vs. 26.5 nM , P = 0.007 ) , findings confirmed through multivariate logistic regression . Lower postoperative 25OHD was associated with increased fluid requirements and intubation duration . Conclusions : Most CHD patients are vitamin-D deficient postoperatively due to low preoperative levels and a significant intraoperative decline . Interventional studies will be required to determine whether prevention of postoperative vitamin D deficiency improves outcome",
"BACKGROUND A high prevalence ( 60 % ) of vitamin D ( VitD ) depletion , defined as a serum 25-hydroxyvitamin D level of preoperative morbidly obese patients . Despite daily supplementation with 800 IU VitD and 1500 mg calcium after Roux-en-Y gastric bypass ( RYGB ) , VitD depletion persists in almost one half ( 44 % ) of patients . However , the optimal management of VitD depletion after RYGB and the potential benefits of such treatment are currently unknown . METHODS A total of 60 VitD-depleted morbidly obese women were r and omly assigned to receive 50,000 IU of VitD weekly after RYGB ( group 1 ; n = 30 ) or no additional VitD after RYGB ( group 2 ; n = 30 ) . All patients received a daily supplement of 800 IU VitD and 1500 mg calcium . The serum calcium , parathyroid hormone , 25-hydroxyvitamin D , bone-specific alkaline phosphatase , urinary N-telopeptide , and bone mineral density were measured preoperatively and 1 year after RYGB . Question naires were used to assess other potential sources of VitD , including sunlight exposure and ingestion of VitD-containing foods/liquids . RESULTS At 1 year after RYGB , VitD depletion and mean 25-hydroxyvitamin D level had improved significantly in group 1 ( 14 % and 37.8 ng/mL , respectively ) compared with the values in group 2 ( 85 % and 15.2 ng/mL , respectively ; P hip bone mineral density decline ( P = .043 ) and a significantly greater resolution of hypertension was seen in group 1 ( 75 % versus 32 % ; P = .029 ) . No significant adverse effects were encountered from pharmacologic VitD therapy . CONCLUSION The results of our study have shown that 50,000 IU of VitD weekly after RYGB safely corrects VitD depletion in most women , attenuates cortical bone loss , and improves resolution of hypertension",
"OBJECTIVES To determine the incidence of vitamin D deficiency in neonates with congenital heart disease and whether differences exist by race . In addition , we determined the effect of cardiopulmonary bypass on vitamin D levels and explored associations between 25-hydroxyvitamin D [ 25(OH)D ] levels and postoperative outcomes . STUDY DESIGN We performed a secondary analysis of a prospect i ve r and omized controlled trial in 70 neonates undergoing cardiac surgery . The neonates ' 25(OH)D levels were measured in the operating room before skin incision ( baseline ) , at the cessation of cardiopulmonary bypass , and at 24 hours postoperatively . Associations between these levels and clinical outcomes were explored . Vitamin D deficiency was defined as a 25(OH)D level Vitamin D deficiency was present in 84 % ( 59/70 ) ; concentrations in African Americans ( n = 20 ) were significantly lower than those of Caucasian/other race/ethnicity ( n = 50 ) ( 10.2 ± 4.2 vs 16.0 ± 5.6 ng/mL , P The 24-hour postoperative 25(OH)D levels were not different from baseline and correlated with a reduced postoperative inotropic requirement ( r = -0.316 , P = .008 ) . CONCLUSIONS Vitamin D deficiency is prevalent in neonates with congenital cardiac defects , and lower postoperative 25(OH)D levels are associated with the need for increased inotropic support in neonates undergoing cardiac operations . These findings support that vitamin D deficiency may play a role in myocardial injury and postoperative recovery and warrants further investigation",
"This article summarizes the new 2011 report on dietary requirements for calcium and vitamin D from the Institute of Medicine ( IOM ) . An IOM Committee charged with determining the population needs for these nutrients in North America conducted a comprehensive review of the evidence for both skeletal and extraskeletal outcomes . The Committee concluded that available scientific evidence supports a key role of calcium and vitamin D in skeletal health , consistent with a cause- and -effect relationship and providing a sound basis for determination of intake requirements . For extraskeletal outcomes , including cancer , cardiovascular disease , diabetes , and autoimmune disorders , the evidence was inconsistent , inconclusive as to causality , and insufficient to inform nutritional requirements . R and omized clinical trial evidence for extraskeletal outcomes was limited and generally uninformative . Based on bone health , Recommended Dietary Allowances ( RDAs ; covering requirements of ≥97.5 % of the population ) for calcium range from 700 to 1300 mg/d for life-stage groups at least 1 yr of age . For vitamin D , RDAs of 600 IU/d for ages 1–70 yr and 800 IU/d for ages 71 yr and older , corresponding to a serum 25-hydroxyvitamin D level of at least 20 ng/ml ( 50 nmol/liter ) , meet the requirements of at least 97.5 % of the population . RDAs for vitamin D were derived based on conditions of minimal sun exposure due to wide variability in vitamin D synthesis from ultraviolet light and the risks of skin cancer . Higher values were not consistently associated with greater benefit , and for some outcomes U-shaped associations were observed , with risks at both low and high levels . The Committee concluded that the prevalence of vitamin D inadequacy in North America has been overestimated . Urgent research and clinical priorities were identified , including re assessment of laboratory ranges for 25-hydroxyvitamin D , to avoid problems of both undertreatment and overtreatment",
"IMPORTANCE Low vitamin D status is linked to increased mortality and morbidity in patients who are critically ill . It is unknown if this association is causal . OBJECTIVE To investigate whether a vitamin D3 treatment regimen intended to restore and maintain normal vitamin D status over 6 months is of health benefit for patients in ICUs . DESIGN , SETTING , AND PARTICIPANTS A r and omized double-blind , placebo-controlled , single-center trial , conducted from May 2010 through September 2012 at 5 ICUs that included a medical and surgical population of 492 critically ill adult white patients with vitamin D deficiency ( ≤20 ng/mL ) assigned to receive either vitamin D3 ( n = 249 ) or a placebo ( n = 243 ) . INTERVENTIONS Vitamin D3 or placebo was given orally or via nasogastric tube once at a dose of 540,000 IU followed by monthly maintenance doses of 90,000 IU for 5 months . MAIN OUTCOMES AND MEASURES The primary outcome was hospital length of stay . Secondary outcomes included , among others , length of ICU stay , the percentage of patients with 25-hydroxyvitamin D levels higher than 30 ng/mL at day 7 , hospital mortality , and 6-month mortality . A predefined severe vitamin D deficiency ( ≤12 ng/mL ) subgroup analysis was specified before data unblinding and analysis . RESULTS A total of 475 patients were included in the final analysis ( 237 in the vitamin D3 group and 238 in the placebo group ) . The median ( IQR ) length of hospital stay was not significantly different between groups ( 20.1 days [ IQR , 11.1 - 33.3 ] for vitamin D3 vs 19.3 days [ IQR , 11.1 - 34.9 ] for placebo ; P = .98 ) . Hospital mortality and 6-month mortality were also not significantly different ( hospital mortality : 28.3 % [ 95 % CI , 22.6%-34.5 % ] for vitamin D3 vs 35.3 % [ 95 % CI , 29.2%-41.7 % ] for placebo ; hazard ratio [ HR ] , 0.81 [ 95 % CI , 0.58 - 1.11 ] ; P = .18 ; 6-month mortality : 35.0 % [ 95 % CI , 29.0%-41.5 % ] for vitamin D3 vs 42.9 % [ 95 % CI , 36.5%-49.4 % ] for placebo ; HR , 0.78 [ 95 % CI , 0.58 - 1.04 ] ; P = .09 ) . For the severe vitamin D deficiency subgroup analysis ( n = 200 ) , length of hospital stay was not significantly different between the 2 study groups : 20.1 days ( IQR , 12.9 - 39.1 ) for vitamin D3 vs 19.0 days ( IQR , 11.6 - 33.8 ) for placebo . Hospital mortality was significantly lower with 28 deaths among 98 patients ( 28.6 % [ 95 % CI , 19.9%-38.6 % ] ) for vitamin D3 compared with 47 deaths among 102 patients ( 46.1 % [ 95 % CI , 36.2%-56.2 % ] ) for placebo ( HR , 0.56 [ 95 % CI , 0.35 - 0.90 ] , P for interaction = .04 ) , but not 6-month mortality ( 34.7 % [ 95 % CI , 25.4%-45.0 % ] for vitamin D3 vs 50.0 % [ 95 % CI , 39.9%-60.1 % ] for placebo ; HR , 0.60 [ 95 % CI , 0.39 - 0.93 ] , P for interaction = .12 ) . CONCLUSIONS AND RELEVANCE Among critically ill patients with vitamin D deficiency , administration of high-dose vitamin D3 compared with placebo did not reduce hospital length of stay , hospital mortality , or 6-month mortality . Lower hospital mortality was observed in the severe vitamin D deficiency subgroup , but this finding should be considered hypothesis generating and requires further study . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01130181",
"PURPOSE Vitamin D is known to contribute to muscular function . The purpose of this study was to determine whether the level of vitamin D is associated with grip strength recovery in women after a distal radius fracture . METHODS We analyzed grip strength recovery after a distal radius fracture in 70 women over age 50 years . We measured vitamin D levels and grip strength recovery , which we analyzed as a function of age , surgical care , baseline vitamin D level , vitamin D supplementation , wrist range of motion , pain level , and radiographic results at 6 months . We performed multivariate analysis to identify factors that independently predicted grip strength recovery at 6 months after injury . RESULTS Grip strength of affected h and s averaged 65 % of the contralateral sides ( range , 25 % to 100 % ) at 6 months after injury . We found no significant correlation between baseline vitamin D level and grip strength recovery . However , baseline vitamin D level correlated with the grip strengths of uninjured sides . Multivariate analysis indicated that younger age , vitamin D supplementation , and greater wrist range of motion were independently associated with better grip strength recovery at 6 months after injury . CONCLUSIONS This study demonstrated that in women with a distal radius fracture , baseline vitamin D level is not associated with grip strength recovery in the injured h and . However , baseline vitamin D level correlated with grip strength in the uninjured h and . In addition , vitamin D supplementation may help grip strength recovery in the injured h and . Further prospect i ve , comparative studies are warranted to confirm the effect of vitamin D supplementation on grip strength recovery ",
"CONTEXT Several cohort studies have reported U-shaped or inverse J-shaped associations between circulating 25-hydroxyvitamin D [ 25OHD ] and clinical outcomes . OBJECTIVE We aim ed to investigate in cardiac surgical patients the association of preoperative 25OHD and 1,25-dihydroxyvitamin D3 [ 1,25(OH)2D3 ] levels with the risk of major adverse cardiac and cerebrovascular events ( MACCE ) . DESIGN A prospect i ve cohort study of adult cardiac surgical patients in 2012 - 2013 was used . SETTING The study was conducted at the Heart and Diabetes Center North Rhine-Westphalia , Germany . PATIENTS A total of 3371 adult patients participated in the study . INTERVENTION None Measurements : The main outcome measure was MACCE until discharge . We categorized vitamin D metabolite levels into subgroups and performed multivariable-adjusted logistic regression analysis to estimate odds ratios ( ORs ) of MACCE . Moreover , we performed multiple regression analysis to assess the association of 25OHD and circulating 1,25(OH)2D3 with preoperative parameters . RESULTS As compared with patients in the 25OHD reference category ( 75 - 100 nmol/L ) , the multivariable-adjusted odds ratios ( OR ) of MACCE was significantly higher in patients with deficient 25OHD levels ( 100 nmol/L ( OR = 1.16 [ 95 % CI : 0.56 - 2.37 ] ) . Poor kidney function was an important predictor of high 25OHD ( > 100 nmol/L ) and low 1,25(OH)2D3 levels . 1,25(OH)2D3 was not independently associated with the incidence of MACCE . CONCLUSIONS In cardiac surgical patients , deficient but not high 25OHD levels are independently associated with the risk of MACCE . Cohort studies should consider potential interrelationships between kidney function , circulating vitamin D metabolite levels , and clinical outcome",
"Kidney transplant recipients usually have low vitamin D levels , especially in the early posttransplantation period , but the association between vitamin D status with renal outcomes is not well described in this population . Here , we studied a prospect i ve cohort of 634 kidney recipients who underwent transplantation at a single institution between January 2005 and June 2010 . In this cohort , low 25-hydroxyvitamin D concentrations 3 months after transplantation did not predict early death or graft loss but were independently associated with lower measured GFR at 12 months ( P=0.001 ) and higher risk for interstitial fibrosis and tubular atrophy ( P=0.01 ) . In contrast , levels of calcium , phosphorus , calcitriol , parathyroid hormone , or fibroblast growth factor-23 were not consistently associated with any of the studied outcomes . In conclusion , low 25-hydroxyvitamin D concentration measured 3 months after transplantation is an independent risk factor for interstitial fibrosis progression and is associated with a lower GFR 1 year after transplantation"
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4118081a-06ff-11f0-808a-c43d1ab1c353
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Objectives Poorly controlled type 2 diabetes mellitus ( T2DM ) is a major international health problem . Our aim was to assess the effectiveness of healthcare interventions , specifically targeting patients with poorly controlled T2DM , which seek to improve glycaemic control and cardiovascular risk in primary care setting s. Design Systematic review . Setting Primary care and community setting s. Included studies R and omised controlled trials ( RCTs ) targeting patients with poor glycaemic control were identified from Pubmed , Embase , Web of Science , Cochrane Library and SCOPUS . Poor glycaemic control was defined as HbA1c over 59 mmol/mol ( 7.5 % ) . Interventions Interventions were classified as organisational , patient-oriented , professional , financial or regulatory . Outcomes Primary outcomes were HbA1c , blood pressure and lipid control . Two review ers independently assessed studies for eligibility , extracted data and assessed study quality . Meta-analyses were undertaken where appropriate using r and om-effects models . Subgroup analysis explored the effects of intervention type , baseline HbA1c , study quality and study duration . Meta-regression analyses were undertaken to investigate identified heterogeneity . Results Forty-two RCTs were identified , including 11 250 patients , with most undertaken in USA . In general , studies had low risk of bias . The main intervention types were patient-directed ( 48 % ) and organisational ( 48 % ) . Overall , interventions reduced HbA1c by −0.34 % ( 95 % CI −0.46 % to −0.22 % ) , but meta-analyses had high statistical heterogeneity . Subgroup analyses suggested that organisational interventions and interventions on those with baseline HbA1c over 9.5 % had better improvements in HbA1c . Meta-regression analyses suggested that only interventions on those with population HbA1c over 9.5 % were more effective . Interventions had a modest improvement of blood pressure and lipids , although baseline levels of control were generally good . Conclusions This review suggests that interventions for T2DM , in primary care , are better targeted at individuals with very poor glycaemic control and that organisational interventions may be more effective
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[
"OBJECTIVE To assess the effects of web-based care management on glucose and blood pressure control over 12 months in patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS For this study , 104 patients with diabetes and HbA(1c ) ( A1C ) > or = 9.0 % who received their care at a Department of Veterans Affairs medical center were recruited . All participants completed a diabetes education class and were r and omized to continue with their usual care ( n = 52 ) or receive web-based care management ( n = 52 ) . The web-based group received a notebook computer , glucose and blood pressure monitoring devices , and access to a care management website . The website provided educational modules , accepted uploads from monitoring devices , and had an internal messaging system for patients to communicate with the care manager . RESULTS Participants receiving web-based care management had lower A1C over 12 months ( P care . Persistent website users had greater improvement in A1C when compared with intermittent users ( -1.9 vs. -1.2 % ; P = 0.051 ) or education and usual care ( -1.4 % ; P website data uploads was associated with a larger decline in A1C ( highest tertile -2.1 % , lowest tertile -1.0 % ; P Hypertensive participants in the web-based group had a greater reduction in systolic blood pressure ( P HDL cholesterol rose and triglycerides fell in the web-based group ( P Web-based care management may be a useful adjunct in the care of patients with poorly controlled diabetes",
"OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with st and ard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A cluster-r and omized clinical trial , the Mobile Diabetes Intervention Study , r and omly assigned 26 primary care practice s to one of three stepped treatment groups or a control group ( usual care ) . A total of 163 patients were enrolled and included in analysis . The primary outcome was change in glycated hemoglobin levels over a 1-year treatment period . Secondary outcomes were changes in patient-reported diabetes symptoms , diabetes distress , depression , and other clinical ( blood pressure ) and laboratory ( lipid ) values . Maximal treatment was a mobile- and web-based self-management patient coaching system and provider decision support . Patients received automated , real-time educational and behavioral messaging in response to individually analyzed blood glucose values , diabetes medications , and lifestyle behaviors communicated by mobile phone . Providers received quarterly reports summarizing patient ’s glycemic control , diabetes medication management , lifestyle behaviors , and evidence -based treatment options . RESULTS The mean declines in glycated hemoglobin were 1.9 % in the maximal treatment group and 0.7 % in the usual care group , a difference of 1.2 % ( P = 0.001 ) over 12 months . Appreciable differences were not observed between groups for patient-reported diabetes distress , depression , diabetes symptoms , or blood pressure and lipid levels ( all P > 0.05 ) . CONCLUSIONS The combination of behavioral mobile coaching with blood glucose data , lifestyle behaviors , and patient self-management data individually analyzed and presented with evidence -based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year",
"Abstract Background : The global epidemic of diabetes calls for innovative interventions . This study evaluated the effectiveness of the Project Dulce model , with and without wireless technology , on glycemic control and other clinical and self-reported outcomes in patients with poorly controlled type 2 diabetes in Mexico . Subjects and Methods : Adults with type 2 diabetes and a glycated hemoglobin A1c ( HbA1c ) level of ≥8 % were recruited from Family Medical Unit # 27 of the Instituto Mexicano del Seguro Social ( IMSS ) in Tijuana , México , and r and omly assigned to one of three groups : Project Dulce – only ( PD ) ; Project Dulce technology-enhanced with mobile tools ( PD-TE ) ; or IMSS st and ard of care/control group ( CG ) . Clinical and self-reported outcomes were assessed at baseline , Month 4 , and Month 10 . Time-by-group interactions and within-group changes were analyzed . Results : HbA1c reductions from baseline to Month 10 were significantly greater in PD-TE ( −3.0 % [ −33 mmol/mol ] ) and PD ( −2.6 % [ −28.7 mmol/mol ] ) compared with CG ( −1.3 % [ −14.2 mmol/mol ] ) ( P = 0.009 and 0.001 , respectively ) . PD-TE and PD also exhibited significant improvement in diabetes knowledge when compared with CG ( P other clinical and self-report indicators but did not vary significantly across groups . Conclusions : Project Dulce with and without wireless technology substantially improved glycemic control and diabetes knowledge in high-risk patients with type 2 diabetes in a Mexican family medical unit , suggesting that integrating peer-led education , nurse coordination , and 3 G wireless technology is an effective approach for improving diabetes outcomes in high-risk population",
"Purpose The purpose of this study is to test the efficacy of a culturally tailored comprehensive type 2 diabetes management intervention for Korean American immigrants ( KAIs ) with type 2 diabetes . Methods A r and omized controlled pilot trial with 2 parallel arms ( intervention vs control ) with a delayed intervention design was used . A total of 79 KAIs , recruited from the Baltimore-Washington area , completed baseline , 18-week , and 30-week follow-ups ( intervention , n = 40 ; control , n = 39 ) . All participants had uncontrolled type 2 diabetes ( hemoglobin A1C ≥7.5 % ) at baseline . The authors ’ comprehensive , self-help intervention program for type 2 diabetes management ( SHIP-DM ) consisted of a 6-week structured psychobehavioral education , home glucose monitoring with teletransmission , and bilingual nurse telephone counseling for 24 weeks . The primary outcome of the study was A1C level , and secondary outcomes included an array of psychobehavioral variables . Results Using analysis of covariance , the findings support that the proposed intervention was effective in significantly lowering A1C and fasting glucose and also in improving psychosocial outcomes in the sample . Specifically , the amount of reduction in A1C among intervention group participants was 1.19 % at 18 weeks and 1.31 % at 30 weeks , with 10 % and 15.5 % of the participants achieving the suggested goal of A1C efficacy of the SHIP-DM intervention composed of a 6-week education program , self-monitoring , and follow-up counseling , in terms of maintaining the improved intervention effects obtained and in terms of glucose control",
"Background Self-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control . We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes . Methods and Findings We performed a r and omized , parallel , investigator-blind controlled trial with central ized r and omization in family practice s in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin ( HbA1c ) > 58 mmol/mol . The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group . The control group received usual care , with at least annual review and more frequent review s for people with poor glycemic or blood pressure control . HbA1c assessed at 9 mo was the primary outcome . Intention-to-treat analyses were performed . 160 people were r and omized to the intervention group and 161 to the usual care group between June 6 , 2011 , and July 19 , 2013 . HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group . The mean ( SD ) HbA1c at follow-up was 63.0 ( 15.5 ) mmol/mol in the intervention group and 67.8 ( 14.7 ) mmol/mol in the usual care group . For primary analysis , adjusted mean HbA1c was 5.60 mmol/mol / 0.51 % lower ( 95 % CI 2.38 to 8.81 mmol/mol/ 95 % CI 0.22 % to 0.81 % , p = 0·0007 ) . For secondary analyses , adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower ( 95 % CI 0.56–5.56 mmHg , p = 0.017 ) and mean ambulatory diastolic blood pressure was 2.17 mmHg lower ( 95 % CI 0.62–3.72 , p = 0.006 ) among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata . No significant differences were identified between groups in weight , treatment pattern , adherence to medication , or quality of life in secondary analyses . There were few adverse events and these were equally distributed between the intervention and control groups . In secondary analysis , there was a greater number of telephone calls between practice nurses and patients in the intervention compared with control group ( rate ratio 7.50 ( 95 % CI 4.45–12.65 , p Supported telemonitoring result ed in clinical ly important improvements in control of glycaemia in patients with type 2 diabetes in family practice . Current Controlled Trials , registration number IS RCT N71674628 . Trial Registration Current Controlled Trials IS RCT N",
"Background Failure to take medication reduces the effectiveness of treatment leading to increased morbidity and mortality . We evaluated the efficacy of a consultation-based intervention to support objective ly-assessed adherence to oral glucose lowering medication ( OGLM ) compared to usual care among people with type 2 diabetes . Methods This was a parallel group r and omised trial in adult patients with type 2 diabetes and HbA1c≥7.5 % ( 58 mmol/mol ) , prescribed at least one OGLM . Participants were allocated to a clinic nurse delivered , innovative consultation-based intervention to strengthen patient motivation to take OGLM regularly and support medicine taking through action-plans , or to usual care . The primary outcome was the percentage of days on which the prescribed dose of medication was taken , measured objective ly over 12 weeks with an electronic medication-monitoring device ( TrackCap , Aardex , Switzerl and ) . The primary analysis was intention-to-treat . Results 211 patients were r and omised between July 1 , 2006 and November 30 , 2008 in 13 British general practice s ( primary care clinics ) . Primary outcome data were available for 194 participants ( 91.9 % ) . Mean ( sd ) percentage of adherent days was 77.4 % ( 26.3 ) in the intervention group and 69.0 % ( 30.8 ) in st and ard care ( mean difference between groups 8.4 % , 95 % confidence interval 0.2 % to 16.7 % , p = 0.044 ) . There was no significant adverse impact on functional status or treatment satisfaction . Conclusions This well-specified , theory based intervention delivered in a single session of 30 min in primary care increased objective ly measured medication adherence , with no adverse effect on treatment satisfaction . These findings justify a definitive trial of this approach to improving medication adherence over a longer period of time , with clinical and cost-effectiveness outcomes to inform clinical practice .Trial registration Current Controlled Trials IS RCT",
"ABSTRACT BACKGROUND Home wireless device monitoring could play an important role in improving the health of patients with poorly controlled chronic diseases , but daily engagement rates among these patients may be low . OBJECTIVE To test the effectiveness of two different magnitudes of financial incentives for improving adherence to remote-monitoring regimens among patients with poorly controlled diabetes . DESIGN R and omized , controlled trial . ( Clinical trials.gov Identifier : NCT01282957 ) . PARTICIPANTS Seventy-five patients with a hemoglobin A1c greater than or equal to 7.5 % recruited from a Primary Care Medical Home practice at the University of Pennsylvania Health System . INTERVENTIONS Twelve weeks of daily home-monitoring of blood glucose , blood pressure , and weight ( control group ; n = 28 ) ; a lottery incentive with expected daily value of $ 2.80 ( n = 26 ) for daily monitoring ; and a lottery incentive with expected daily value of $ 1.40 ( n = 21 ) for daily monitoring . MAIN MEASURES Daily use of three home-monitoring devices during the three-month intervention ( primary outcome ) and during the three-month follow-up period and change in A1c over the intervention period ( secondary outcomes ) .KEY RESULTS Incentive arm participants used devices on a higher proportion of days relative to control ( 81 % low incentive vs. 58 % , P = 0.007 ; 77 % high incentive vs. 58 % , P = 0.02 ) during the three-month intervention period . There was no difference in adherence between the two incentive arms ( P = 0.58 ) . When incentives were removed , adherence in the high incentive arm declined while remaining relatively high in the low incentive arm . In month 6 , the low incentive arm had an adherence rate of 62 % compared to 35 % in the high incentive arm ( P = 0.015 ) and 27 % in the control group ( P = 0.002 ) . CONCLUSIONS A daily lottery incentive worth $ 1.40 per day improved monitoring rates relative to control and had significantly better efficacy once incentives were removed than a higher incentive",
"PURPOSE To evaluate the effects of a collaborative case management intervention for patients with poorly controlled type 2 diabetes on glycemic control , intermediate cardiovascular outcomes , satisfaction with care , and re source utilization . METHODS We conducted a r and omized controlled trial at two Department of Veterans Affairs Medical Centers involving 246 veterans with diabetes and baseline hemoglobin A(1C ) ( HbA(1C ) ) levels > or=7.5 % . Two nurse practitioner case managers worked with patients and their primary care providers , monitoring and coordinating care for the intervention group for 18 months through the use of telephone contacts , collaborative goal setting , and treatment algorithms . Control patients received educational material s and usual care from their primary care providers . RESULTS At the conclusion of the study , both case management and control patients remained under poor glycemic control and there was little difference between groups in mean exit HbA(1C ) level ( 9.3 % vs. 9.2 % ; difference = 0.1 % ; 95 % confidence interval : -0.4 % to 0.7 % ; P = 0.65 ) . There was also no evidence that the intervention result ed in improvements in low-density lipoprotein cholesterol level or blood pressure control or greater intensification in medication therapy . However , intervention patients were substantially more satisfied with their diabetes care , with 82 % rating their providers as better than average compared with 64 % of patients in the control group ( P = 0.04 ) . CONCLUSION An intervention of collaborative case management did not improve key physiologic outcomes for high-risk patients with type 2 diabetes . The type of patients targeted for intervention , organizational factors , and program structure are likely critical determinants of the effectiveness of case management . Health systems must underst and the potential limitations before expending substantial re sources on case management , as the expected improvements in outcomes and downstream cost savings may not always be realized",
"Objective . Patients with type 2 diabetes often fail to achieve self-management goals . This study tested the impact on glycemic control of a two-way text messaging program that provided behavioral coaching , education , and testing reminders to enrolled individuals with type 2 diabetes in the context of a clinic-based quality improvement initiative . The secondary aim examined patient interaction and satisfaction with the program . Methods . Ninety-three adult patients with poorly controlled type 2 diabetes ( A1C > 8 % ) were recruited from 18 primary care clinics in three counties for a 6-month study . Patients were r and omized by a computer to one of two arms . Patients in both groups continued with their usual care ; patients assigned to the intervention arm also received from one to seven diabetes-related text messages per day depending on the choices they made at enrollment . At 90 and 180 days , A1C data were obtained from the electronic health record and analyzed to determine changes from baseline for both groups . An exit survey was used to assess satisfaction . Enrollment behavior and interaction data were pulled from a Web-based administrative portal maintained by the technology vendor . Results . Patients used the program in a variety of ways . Twenty-nine percent of program users demonstrated frequent engagement ( texting responses at least three times per week ) for a period of ≥90 days . Survey results indicate very high satisfaction with the program . Both groups ’ average A1C decreased from baseline , possibly reflecting a broader quality improvement effort underway in participating clinics . At 90 and 180 days , there was no statistically significant difference between the intervention and control groups in terms of change in A1C ( P > 0.05 ) . Conclusions . This study demonstrated a practical approach to implementing and monitoring a mobile health intervention for self-management support across a wide range of independent clinic practice",
"Objective To determine the effectiveness of a patient decision aid ( PDA ) to improve decision quality and glycaemic control in people with diabetes making treatment choices using a cluster r and omised controlled trial ( RCT ) . Design A cluster RCT . Setting 49 general practice s in UK r and omised into intervention ( n=25 ) and control ( n=24 ) . Participants General practice s Inclusion criteria : > 4 medical partners ; list size > 7000 ; and a diabetes register with > 1 % of practice population . 191 practice s assessed for eligibility , and 49 practice s r and omised and completed the study . Patients People with type 2 diabetes mellitus ( T2DM ) taking at least two oral glucose-lowering drugs with maximum tolerated dose with a glycosolated haemoglobin ( HbA1c ) greater than 7.4 % ( IFCC HbA1c > 57 mmol/mol ) or advised in the preceeding 6 months to add or consider changing to insulin therapy . Exclusion criteria : currently using insulin therapy ; difficulty reading or underst and ing English ; difficulty in underst and ing the purpose of the study ; visual or cognitive impairment or mentally ill . A total of 182 assessed for eligibility , 175 r and omised to 95 intervention and 80 controls , and 167 completion and analysis . Intervention Brief training of clinicians and use of PDA with patients in single consultation . Primary outcomes Decision quality ( Decisional Conflict Scores , knowledge , realistic expectations and autonomy ) and glycaemic control ( glycosolated haemoglobin , HbA1c ) . Secondary outcomes Knowledge and realistic expectations of the risks and benefits of insulin therapy and diabetic complications . Results Intervention group : lower total Decisional Conflict Scores ( 17.4 vs 25.2 , p better knowledge ( 51.6 % vs 28.8 % , p realistic expectations ( risk of ‘ hypo ’ , ‘ weight gain ’ , ‘ complications ’ ; 81.0 % vs 5.2 % , 70.5 % vs 5.3 % , 26.3 % vs 5.0 % respectively , p more autonomous in decision-making ( 64.1 % vs 42.9 % , p=0.012 ) . No significant difference in the glycaemic control between the two groups . Conclusions Use of the P AND As decision aid reduces decisional conflict , improves knowledge , promotes realistic expectations and autonomy in people with diabetes making treatment choices in general practice . IS RCT N Trials Register Number 14842077",
"OBJECTIVE The Northern Manhattan Diabetes Community Outreach Project evaluated whether a community health worker ( CHW ) intervention improved clinical ly relevant markers of diabetes care in adult Hispanics . RESEARCH DESIGN AND METHODS Participants were adult Hispanics , ages 35–70 years , with recent hemoglobin A1c ( A1C ) ≥8 % ( ≥64 mmol/mol ) , from a university-affiliated network of primary care practice s in northern Manhattan ( New York City , NY ) . They were r and omized to a 12-month CHW intervention ( n = 181 ) , or enhanced usual care ( educational material s mailed at 4-month intervals , preceded by phone calls , n = 179 ) . The primary outcome was A1C at 12 months ; the secondary outcomes were systolic blood pressure ( SBP ) , diastolic blood pressure , and LDL-cholesterol levels . RESULTS There was a nonsignificant trend toward improvement in A1C levels in the intervention group ( from unadjusted mean A1C of 8.77 to 8.40 % ) , as compared with usual care ( from 8.58 to 8.53 % ) ( P = 0.131 ) . There was also a nonsignificant trend toward an increase in SBP and LDL cholesterol in the intervention arm . Intervention fidelity , measured as the number of contacts in the intervention arm ( visits , phone contacts , group support , and nutritional education ) , showed a borderline association with greater A1C reduction ( P = 0.054 ) . When assessed separately , phone contacts were associated with greater A1C reduction ( P = 0.04 ) . CONCLUSIONS The trend toward A1C reduction with the CHW intervention failed to achieve statistical significance . Greater intervention fidelity may achieve better glycemic control , and more accessible treatment models , such as phone-based interventions , may be more efficacious in socioeconomically disadvantaged population ",
"OBJECTIVE To evaluate an online disease management system supporting patients with uncontrolled type 2 diabetes . MATERIAL S AND METHODS Engaging and Motivating Patients Online With Enhanced Re sources for Diabetes was a 12-month parallel r and omized controlled trial of 415 patients with type 2 diabetes with baseline glycosylated hemoglobin ( A1C ) values ≥7.5 % from primary care sites sharing an electronic health record . The intervention included : ( 1 ) wirelessly uploaded home glucometer readings with graphical feedback ; ( 2 ) comprehensive patient-specific diabetes summary status report ; ( 3 ) nutrition and exercise logs ; ( 4 ) insulin record ; ( 5 ) online messaging with the patient 's health team ; ( 6 ) nurse care manager and dietitian providing advice and medication management ; and ( 7 ) personalized text and video educational ' nuggets ' dispensed electronically by the care team . A1C was the primary outcome variable . RESULTS Compared with usual care ( UC , n=189 ) , patients in the intervention ( INT , n=193 ) group had significantly reduced A1C at 6 months ( -1.32 % INT vs -0.66 % UC ; p had improved diabetes control ( > 0.5 % reduction in A1C ) than UC patients at 12 months ( 69.9 ( 95 % CI 63.2 to 76.5 ) vs 55.4 ( 95 % CI 48.4 to 62.5 ) ; p=0.006 ) . CONCLUSIONS A nurse-led , multidisciplinary health team can manage a population of diabetic patients in an online disease management program . INT patients achieved greater decreases in A1C at 6 months than UC patients , but the differences were not sustained at 12 months . More INT than UC patients achieved improvement in A1C ( > 0.5 % decrease ) . Trial registered in clinical trials.gov : # NCT00542204",
"OBJECTIVE Despite the importance of self-management support ( SMS ) , few studies have compared SMS interventions , involved diverse population s , or entailed implementation in safety net setting s. We examined the effects of two SMS strategies across outcomes corresponding to the Chronic Care Model . RESEARCH DESIGN AND METHODS A total of 339 out patients with poorly controlled diabetes from county-run clinics were enrolled in a three-arm trial . Participants , more than half of whom spoke limited English , were uninsured , and /or had less than a high school education , were r and omly assigned to usual care , interactive weekly automated telephone self-management support with nurse follow-up ( ATSM ) , or monthly group medical visits with physician and health educator facilitation ( GMV ) . We measured 1-year changes in structure ( Patient Assessment of Chronic Illness Care [ PACIC ] ) , communication processes ( Interpersonal Processes of Care [ IPC ] ) , and outcomes ( behavioral , functional , and metabolic ) . RESULTS Compared with the usual care group , the ATSM and GMV groups showed improvements in PACIC , with effect sizes of 0.48 and 0.50 , respectively ( P improvements in IPC ( effect sizes 0.40 vs. usual care and 0.25 vs. GMV , P improvements in self-management behavior versus the usual care arm ( P fewer bed days per month than the usual care group ( −1.7 days , P = 0.05 ) and the GMV group ( −2.3 days , P less interference with daily activities than the usual care group ( odds ratio 0.37 , P = 0.02 ) . We observed no differences in A1C change . CONCLUSIONS Patient-centered SMS improves certain aspects of diabetes care and positively influences self-management behavior . ATSM seems to be a more effective communication vehicle than GMV in improving behavior and quality of life",
"Background Health outcomes for Indigenous Australians with diabetes in remote areas remain poor , including high rates of avoidable complications which could be reduced with better primary level care . We aim ed to evaluate the effectiveness of a community-based health-worker led case management approach to the care of Indigenous adults with poorly controlled type 2 diabetes in primary care services in remote northern Australia . Methods Two hundred and thirteen adults with poorly controlled diabetes ( HbA1c > 8.5 % ) and significant comorbidities in 12 remote communities were r and omly assigned by service cluster to receive chronic care co-ordination from a community-based health worker supported by a clinical outreach team , or to a waitlist control group which received usual care . Results At baseline , mean age of participants was 47.9 years , 62.4 % were female , half were Aboriginal and half identified as Torres Strait Isl and er , 67 % had less than 12 years of education , 39 % were smokers , median income was $ 18,200 and 47 % were unemployed . Mean HbA1c was 10.7 % ( 93 mmol/mol ) and BMI 32.5 . At follow-up after 18 months , HbA1c reduction was significantly greater in the intervention group ( −1.0 % vs −0.2 % , SE ( diff ) = 0.2 , p = 0.02 ) . There were no significant differences between the groups for blood pressure , lipid profile , BMI or renal function . Intervention group participants were more likely to receive nutrition and dental services according to scheduled care plans . Smoking rates were unchanged . Conclusions A culturally safe , community level health-worker led model of diabetes care for high risk patients can be effective in improving diabetes control in remote Indigenous Australian communities where there is poor access to mainstream services . This approach can be effective in other remote setting s , but requires longer term evaluation to capture accrued benefits .Trial registration ANZCTR 12610000812099 , Registered 29 September 2010",
"BACKGROUND The effects of intensive glucose control on cardiovascular events in patients with long-st and ing type 2 diabetes mellitus remain uncertain . METHODS We r and omly assigned 1791 military veterans ( mean age , 60.4 years ) who had a suboptimal response to therapy for type 2 diabetes to receive either intensive or st and ard glucose control . Other cardiovascular risk factors were treated uniformly . The mean number of years since the diagnosis of diabetes was 11.5 , and 40 % of the patients had already had a cardiovascular event . The goal in the intensive-therapy group was an absolute reduction of 1.5 percentage points in the glycated hemoglobin level , as compared with the st and ard-therapy group . The primary outcome was the time from r and omization to the first occurrence of a major cardiovascular event , a composite of myocardial infa rct ion , stroke , death from cardiovascular causes , congestive heart failure , surgery for vascular disease , inoperable coronary disease , and amputation for ischemic gangrene . RESULTS The median follow-up was 5.6 years . Median glycated hemoglobin levels were 8.4 % in the st and ard-therapy group and 6.9 % in the intensive-therapy group . The primary outcome occurred in 264 patients in the st and ard-therapy group and 235 patients in the intensive-therapy group ( hazard ratio in the intensive-therapy group , 0.88 ; 95 % confidence interval [ CI ] , 0.74 to 1.05 ; P=0.14 ) . There was no significant difference between the two groups in any component of the primary outcome or in the rate of death from any cause ( hazard ratio , 1.07 ; 95 % CI , 0.81 to 1.42 ; P=0.62 ) . No differences between the two groups were observed for microvascular complications . The rates of adverse events , predominantly hypoglycemia , were 17.6 % in the st and ard-therapy group and 24.1 % in the intensive-therapy group . CONCLUSIONS Intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events , death , or microvascular complications with the exception of progression of albuminuria ( P = 0.01 ) [ added ] . ( Clinical Trials.gov number , NCT00032487 .",
"OBJECTIVE To evaluate the effect of a culturally sensitive diabetes self-management education program that uses a low-cost , peer-educator format ( Project Dulce ) on glucose control and metabolic parameters in low-income Mexican Americans with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 207 Mexican-American patients recruited from federally funded community health centers in San Diego County with HbA1c > 8 % were r and omly assigned to the Project Dulce peer intervention or continuation of st and ard diabetes care . The primary outcome of interest was HbA1c . RESULTS The majority of subjects were born in Mexico , were female , were middle-aged , had less than an eighth- grade education , and had high baseline HbA1c levels . Significant time-by-group interaction effects for HbA1c ( P = 0.02 ) and diastolic blood pressure ( P = 0.04 ) indicated that the Project Dulce group exhibited greater improvement ( i.e. , decreases ) across time . Within-group analyses showed that the intervention group exhibited significant improvements from baseline to month 4 in absolute levels of HbA1c ( −1.7 % , P = 0.001 ) and HDL cholesterol ( + 1.4 mg/dL , P = 0.01 ) and from baseline to month 10 in absolute levels of HbA1c ( −1.5 % , P = 0.01 ) , total cholesterol ( −7.2 mg/dL , P = 0.04 ) , HDL cholesterol ( + 1.6 mg/dL , P = 0.01 ) , and LDL cholesterol ( −8.1 mg/dL , P = 0.02 ) . No significant changes were noted in the control group . CONCLUSIONS This r and omized trial , using the Project Dulce model of culturally sensitive , peer-led education , demonstrates improvement in glucose and metabolic control and suggests that this low-cost approach to self-management education for high-risk diabetic population s is effective",
"Background Diabetes self-care by patients has been shown to assist in the reduction of disease severity and associated medical costs . We compared the effectiveness of two different diabetes self-care interventions on glycemic control in a racially/ethnically diverse population . We also explored whether reductions in glycated hemoglobin ( HbA1c ) will be more marked in minority persons . Methods We conducted an open-label r and omized controlled trial of 376 patients with type 2 diabetes aged ≥18 years and whose last measured HbA1c was ≥7.5 % ( ≥58 mmol/mol ) . Participants were r and omized to : 1 ) a Chronic Disease Self-Management Program ( CDSMP ; n = 101 ) ; 2 ) a diabetes self-care software on a personal digital assistant ( PDA ; n = 81 ) ; 3 ) a combination of interventions ( CDSMP + PDA ; n = 99 ) ; or 4 ) usual care ( control ; n = 95 ) . Enrollment occurred January 2009-June 2011 at seven regional clinics of a university-affiliated multi-specialty group practice . The primary outcome was change in HbA1c from r and omization to 12 months . Data were analyzed using a multilevel statistical model . Results Average baseline HbA1c in the CDSMP , PDA , CDSMP + PDA , and control arms were 9.4 % , 9.3 % , 9.2 % , and 9.2 % , respectively . HbA1c reductions at 12 months for the groups averaged 1.1 % , 0.7 % , 1.1 % , and 0.7 % , respectively and did not differ significantly from baseline based on the model ( P = .771 ) . Besides the participants in the PDA group reporting eating more high-fat foods compared to their counterparts ( P in HbA1c for minority persons but rather modest reductions for all racial/ethnic groups . Conclusions Although behavioral and technological interventions can result in some modest improvements in glycemic control , these interventions did not fare significantly better than usual care in achieving glycemic control . More research is needed to underst and how these interventions can be most effective in clinical practice . The reduction in HbA1c levels found in our control group that received usual care also suggests that good routine care in an integrated healthcare system can lead to better glycemic control . Trial registration Clinical trials.gov Identifier : NCT01221090",
"BACKGROUND The Veterans Affairs Diabetes Trial previously showed that intensive glucose lowering , as compared with st and ard therapy , did not significantly reduce the rate of major cardiovascular events among 1791 military veterans ( median follow-up , 5.6 years ) . We report the extended follow-up of the study participants . METHODS After the conclusion of the clinical trial , we followed participants , using central data bases to identify procedures , hospitalizations , and deaths ( complete cohort , with follow-up data for 92.4 % of participants ) . Most participants agreed to additional data collection by means of annual surveys and periodic chart review s ( survey cohort , with 77.7 % follow-up ) . The primary outcome was the time to the first major cardiovascular event ( heart attack , stroke , new or worsening congestive heart failure , amputation for ischemic gangrene , or cardiovascular-related death ) . Secondary outcomes were cardiovascular mortality and all-cause mortality . RESULTS The difference in glycated hemoglobin levels between the intensive-therapy group and the st and ard-therapy group averaged 1.5 percentage points during the trial ( median level , 6.9 % vs. 8.4 % ) and declined to 0.2 to 0.3 percentage points by 3 years after the trial ended . Over a median follow-up of 9.8 years , the intensive-therapy group had a significantly lower risk of the primary outcome than did the st and ard-therapy group ( hazard ratio , 0.83 ; 95 % confidence interval [ CI ] , 0.70 to 0.99 ; P=0.04 ) , with an absolute reduction in risk of 8.6 major cardiovascular events per 1000 person-years , but did not have reduced cardiovascular mortality ( hazard ratio , 0.88 ; 95 % CI , 0.64 to 1.20 ; P=0.42 ) . No reduction in total mortality was evident ( hazard ratio in the intensive-therapy group , 1.05 ; 95 % CI , 0.89 to 1.25 ; P=0.54 ; median follow-up , 11.8 years ) . CONCLUSIONS After nearly 10 years of follow-up , patients with type 2 diabetes who had been r and omly assigned to intensive glucose control for 5.6 years had 8.6 fewer major cardiovascular events per 1000 person-years than those assigned to st and ard therapy , but no improvement was seen in the rate of overall survival . ( Funded by the VA Cooperative Studies Program and others ; VADT Clinical Trials.gov number , NCT00032487 . )",
"Background There is a paucity of evidence supporting the effectiveness of diabetes self-management education ( DSME ) in improving mental health-related quality of life ( HRQoL ) for African American and Latinos . Also , among studies supporting the favorable effects of DSME on mental HRQoL , the direct effect of DSME that is independent of improved glycemic control has never been investigated . The objectives of this study were to investigate the effect of community-based DSME intervention targeting empowerment on mental HRQoL and to determine whether the effect is direct or mediated by glycemic control . Methods We conducted secondary analyses of data from the Diabetes Self-Care Study , a r and omized controlled trial of a community-based DSME intervention . Study participants ( n = 516 ) were African Americans and Latinos 55 years or older with poorly controlled diabetes ( HbA1c ≥ 8.0 % ) recruited from senior centers and churches in Los Angeles . The intervention group received six weekly small-group self-care sessions based on the empowerment model . The control group received six lectures on unrelated geriatrics topics . The primary outcome variable in this secondary analysis was the change in Mental Component Summary score ( MCS-12 ) from the SF-12 Health Survey between baseline and six-month follow-up . We used the change in HbA1c during the study period as the main mediator of interest in our causal mediation analysis . Additionally , possible mediations via social support and perceived empowerment attributable to the program were examined . Results MCS-12 increased by 1.4 points on average in the intervention group and decreased by 0.2 points in the control group ( difference-in-change : 1.6 points , 95 % CI : 0.1 to 3.2 ) . In the causal mediation analysis , the intervention had a direct effect on MCS-12 improvement ( 1.7 points , 95 % CI : 0.2 to 3.2 ) with no indirect effects mediated via HbA1c change ( −0.1 points , 95 % CI : −0.4 to 0.1 ) , social support ( 0.1 points ) , and perception of empowerment ( 0.1 points ) . Conclusions This Diabetes Self-Care Study empowerment intervention had a modest positive impact on mental HRQoL not mediated by the improvement in glycemic control , as well as social support and perception of empowerment . This favorable effect on mental HRQoL may be a separate clinical advantage of this DSME intervention . Trial Registration Clinical Trial.gov NCT00263835",
"OBJECTIVE To evaluate the effectiveness of a culturally adapted , primary care – based nurse – community health worker ( CHW ) team intervention to support diabetes self-management on diabetes control and other biologic measures . RESEARCH DESIGN AND METHODS Two hundred sixty-eight Samoan participants with type 2 diabetes were recruited from a community health center in American Samoa and were r and omly assigned by village clusters to the nurse-CHW team intervention or to a wait-list control group that received usual care . RESULTS Participants had a mean age of 55 years , 62 % were female , mean years of education were 12.5 years , 41 % were employed , and mean HbA1c was 9.8 % at baseline . At 12 months , mean HbA1c was significantly lower among CHW participants , compared with usual care , after adjusting for confounders ( b = −0.53 ; SE = 0.21 ; P = 0.03 ) . The odds of making a clinical ly significant improvement in HbA1c of at least 0.5 % in the CHW group was twice the odds in the usual care group after controlling for confounders ( P = 0.05 ) . There were no significant differences in blood pressure , weight , or waist circumference at 12 months between groups . CONCLUSIONS A culturally adapted nurse-CHW team intervention was able to significantly improve diabetes control in the U.S. Territory of American Samoa . This represents an important translation of an evidence -based model to a high-risk population and a re source -poor setting",
"Objective To evaluate the effectiveness of goal focused telephone coaching by practice nurses in improving glycaemic control in patients with type 2 diabetes in Australia . Design Prospect i ve , cluster r and omised controlled trial , with general practice s as the unit of r and omisation . Setting General practice s in Victoria , Australia . Participants 59 of 69 general practice s that agreed to participate recruited sufficient patients and were r and omised . Of 829 patients with type 2 diabetes ( glycated haemoglobin ( HbA1c ) > 7.5 % in the past 12 months ) who were assessed for eligibility , 473 ( 236 from 30 intervention practice s and 237 from 29 control practice s ) agreed to participate . Intervention Practice nurses from intervention practice s received two days of training in a telephone coaching programme , which aim ed to deliver eight telephone and one face to face coaching episodes per patient . Main outcome measures The primary end point was mean absolute change in HbA1c between baseline and 18 months in the intervention group compared with the control group . Results The intervention and control patients were similar at baseline . None of the practice s dropped out over the study period ; however , patient attrition rates were 5 % in each group ( 11/236 and 11/237 in the intervention and control group , respectively ) . The median number of coaching sessions received by the 236 intervention patients was 3 ( interquartile range 1 - 5 ) , of which 25 % ( 58/236 ) did not receive any coaching sessions . At 18 months ’ follow-up the effect on glycaemic control did not differ significantly ( mean difference 0.02 , 95 % confidence interval −0.20 to 0.24 , P=0.84 ) between the intervention and control groups , adjusted for HbA1c measured at baseline and the clustering . Other biochemical and clinical outcomes were similar in both groups . Conclusions A practice nurse led telephone coaching intervention implemented in the real world primary care setting produced comparable outcomes to usual primary care in Australia . The addition of a goal focused coaching role onto the ongoing generalist role of a practice nurse without prescribing rights was found to be ineffective . Trial registration Current Controlled Trials IS RCT N50662837",
"OBJECTIVE To evaluate the effect of case management by a clinical pharmacist on glycemic control and preventive measures in patients with type 2 diabetes mellitus . STUDY DESIGN R and omized controlled trial in a university-affiliated primary care internal medicine clinic . METHODS We recruited 80 patients with poorly controlled type 2 diabetes mellitus . A clinical pharmacist provided evaluation and modification of pharmacotherapy , self-management diabetes education , and reinforcement of diabetes complications screening processes through clinic visits and telephone follow-up . The main clinical outcome was hemoglobin A1C ( HbA1C ) level ; process measures included HbA1C and low-density lipoprotein measurement , retinal examination , urine microalbumin testing ( or use of angiotensin-converting enzyme inhibitors ) , and monofilament screening for diabetic neuropathy . RESULTS Patients in the intervention and control groups were similar in age , sex , mean HbA1C levels ( 10.1 % and 10.2 % , respectively ; P = .65 ) , and current treatment regimens at baseline . Patients who received case management by the clinical pharmacist achieved greater reduction in HbA1C levels than those in the control group ( 2.1 % vs 0.9 % , P = .03 ) . Three of the 5 process measures were conducted more frequently in the intervention group than the control group , including low-density lipoprotein measurement ( 100.0 % vs 85.7 % , P = .02 ) , retinal examination ( 97.3 % vs 74.3 % ) , and monofilament foot screening ( 92.3 % vs 62.9 % ) . CONCLUSIONS Proactive diabetes case management by a pharmacist substantially improved glycemic control and diabetes process-of-care measures . This approach , integrated with and based in the primary care setting , was an effective and efficient approach to improving care , especially for those with poor glycemic control at baseline",
"PURPOSE Peer health coaches offer a potential model for extending the capacity of primary care practice s to provide self-management support for patients with diabetes . We conducted a r and omized controlled trial to test whether clinic-based peer health coaching , compared with usual care , improves glycemic control for low-income patients who have poorly controlled diabetes . METHOD We undertook a r and omized controlled trial enrolling patients from 6 public health clinics in San Francisco . Twenty-three patients with a glycated hemoglobin ( HbA1C ) level of less than 8.5 % , who completed a 36-hour health coach training class , acted as peer coaches . Patients from the same clinics with HbA1C levels of 8.0 % or more were recruited and r and omized to receive health coaching ( n = 148 ) or usual care ( n = 151 ) . The primary outcome was the difference in change in HbA1C levels at 6 months . Secondary outcomes were proportion of patients with a decrease in HbA1C level of 1.0 % or more and proportion of patients with an HbA1C level of less than 7.5 % at 6 months . Data were analyzed using a linear mixed model with and without adjustment for differences in baseline variables . RESULTS At 6 months , HbA1C levels had decreased by 1.07 % in the coached group and 0.3 % in the usual care group , a difference of 0.77 % in favor of coaching ( P = .01 , adjusted ) . HbA1C levels decreased 1.0 % or more in 49.6 % of coached patients vs 31.5 % of usual care patients ( P = .001 , adjusted ) , and levels at 6 months were less than 7.5 % for 22.0 % of coached vs 14.9 % of usual care patients ( P = .04 , adjusted ) . CONCLUSIONS Peer health coaching significantly improved diabetes control in this group of low-income primary care patients",
"OBJECTIVE To evaluate the effectiveness of a psychological , family-based intervention to improve diabetes-related outcomes in patients with poorly controlled type 2 diabetes . METHODS This study was a r and omized controlled trial of a psychological family-based intervention targeted at individuals with poorly controlled type 2 diabetes . Recruitment and follow-up occurred at specialist diabetes clinics . Patients were r and omly allocated to an intervention group ( n=60 ) or a control group ( n=61 ) . Poor control was defined as at least 2 of the patient 's last 3 glycated hemoglobin ( A1C ) readings at > 8.0 % . The intervention consisted of 2 sessions delivered by a health psychologist to the patient and a family member in the patient 's home , with a third session involving a 15-minute follow-up telephone call . RESULTS At 6-month follow-up , the intervention group reported significantly lower mean A1C levels than the control group ( 8.4 % [ SD=0.99 % ] vs 8.8 % [ SD=1.36 % ] ; P=.04 ) . The intervention was most effective in those with the poorest control at baseline ( A1C>9.5 % ) ( intervention 8.7 % [ SD=1.16 % , n=15 ] vs control 9.9 % [ SD=1.31 % , n=15 ] ; P=.01 ) . The intervention group also reported statistically significant improvements in beliefs about diabetes , psychological well-being , diet , exercise , and family support . CONCLUSIONS After participating in a family-based intervention targeting negative and /or inaccurate illness perceptions , patients with poorly controlled type 2 diabetes showed improvements in A1C levels and other outcomes . Our results suggest that adding a psychological , family-based component to usual diabetes care may help improve diabetes management",
"OBJECTIVE To investigate the effect of pharmacist management of poorly controlled diabetes mellitus in a community-based primary care group . STUDY DESIGN R and omized controlled trial of pharmacist management of diabetes compared with usual medical care . METHODS Patients 18 years or older with glycosylated hemoglobin ( A1C ) levels of 9.0 % or higher were enrolled . Patients were r and omly assigned to an intervention group ( n = 52 ) or a control group ( n = 51 ) . Management in the control group included the use of registries and targeted patient outreach . The intervention group participated in the same outreach program plus medication management , patient education , and disease control by a pharmacist . RESULTS Nonparametric data showed median A1C decreases of 1.50 % for the intervention group and 0.40 % for the control group ( P = .06 ) . Significantly more patients in the intervention group improved their A1C level by at least 1.0 % relative to the control group ( 67.3 % vs 41.2 % , P = .02 ) . Most of this benefit was seen for patients of nonwhite race/ethnicity compared with control subjects ( 56.3 % vs 22.7 % , P = .03 ) . Male patients showed significantly greater benefit as well , with a median A1C decrease of 1.90 % vs 0.15 % for controls ( P = .03 ) . CONCLUSIONS Patients with poorly controlled diabetes improved A1C levels significantly when pharmacist management was added to an aggressive organizational diabetes management program . Our results suggest that clinical ly trained pharmacists can help primary care providers improve diabetes management , especially among male patients and among patients of nonwhite race/ethnicity ",
"ABSTRACT Background Several trials have demonstrated the efficacy of nurse telephone case management for diabetes ( DM ) and hypertension ( HTN ) in academic or vertically integrated systems . Little is known about the real-world potency of these interventions . Objective To assess the effectiveness of nurse behavioral management of DM and HTN in community practice s among patients with both diseases . Design The study was design ed as a patient-level r and omized controlled trial . Participants Participants included adult patients with both type 2 DM and HTN who were receiving care at one of nine community fee-for-service practice s. Subjects were required to have inadequately controlled DM ( hemoglobin A1c [ A1c ] ≥ 7.5 % ) but could have well-controlled HTN . Interventions All patients received a call from a nurse experienced in DM and HTN management once every two months over a period of two years , for a total of 12 calls . Intervention patients received tailored DM- and HTN- focused behavioral content ; control patients received non-tailored , non-interactive information regarding health issues unrelated to DM and HTN ( e.g. , skin cancer prevention).Main Outcomes and Measures Systolic blood pressure ( SBP ) and A1c were co- primary outcomes , measured at 6 , 12 , and 24 months ; 24 months was the primary time point . Results Three hundred seventy-seven subjects were enrolled ; 193 were r and omized to intervention , 184 to control . Subjects were 55 % female and 50 % white ; the mean baseline A1c was 9.1 % ( SD = 1 % ) and mean SBP was 142 mmHg ( SD = 20 ) . Eighty-two percent of scheduled interviews were conducted ; 69 % of intervention patients and 70 % of control patients reached the 24-month time point . Expressing model estimated differences as ( intervention – control ) , at 24 months , intervention patients had similar A1c [ diff = 0.1 % , 95 % CI ( −0.3 , 0.5 ) , p = 0.51 ] and SBP [ diff = −0.9 mmH g , 95 % CI ( −5.4 , 3.5 ) , p = 0.68 ] values compared to control patients . Likewise , DBP ( diff = 0.4 mmHg , p = 0.76 ) , weight ( diff = 0.3 kg , p = 0.80 ) , and physical activity levels ( diff = 153 MET-min/week , p = 0.41 ) were similar between control and intervention patients . Results were also similar at the 6- and 12-month time points . Conclusions In nine community fee-for-service practice s , telephonic nurse case management did not lead to improvement in A1c or SBP . Gains seen in telephonic behavioral self-management interventions in optimal setting s may not translate to the wider range of primary care setting",
"BACKGROUND : There is limited information from r and omized controlled studies about the influence of pharmacist interventions on diabetes control . OBJECTIVE : To evaluate the effect of a pharmacist intervention on improving diabetes control ; secondary endpoints were medication appropriateness and self-reported adherence . METHODS : A r and omized , controlled , multi-clinic trial was conducted in the University of Washington Medicine Neighborhood Clinics . Seventy-seven subjects , ⩾18 years old with a hemoglobin ( Hb ) A1c ⩾9 % at baseline and taking at least one oral diabetes medication , were r and omized to receive a pharmacist intervention ( n = 43 ) or usual care ( n = 34 ) for 6 months followed by a 6-month usual-care observation period for both groups . Subjects met with a clinical pharmacist to establish and initiate a diabetes care plan followed by weekly visits or telephone calls to facilitate diabetes management and adherence . HbA1c , medication appropriateness , and self-reported adherence were assessed at baseline , 6 months , and 12 months . RESULTS : The mean HbA1c did not differ between groups over the 12-month period ( p = 0.61 ) . A reduction in HbA1c was noted for both groups over time compared with baseline ( p = 0.001 ) ; however , control subjects relied more heavily on provider visits . Medication appropriateness was not improved for diabetes medications ( p = 0.65 ) . Self-reported adherence was not significantly improved by the intervention . CONCLUSIONS : This pharmacist intervention did not significantly improve diabetes control , but did allow for similar HbA1c control with fewer physician visits . Medication appropriateness and self-reported adherence compared with usual care in individuals with poorly controlled diabetes were not changed",
"Abstract Objective : To determine the relation between exposure to glycaemia over time and the risk of macrovascular or microvascular complications in patients with type 2 diabetes . Design : Prospect i ve observational study . Setting : 23 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Participants : 4585 white , Asian Indian , and Afro-Caribbean UKPDS patients , whether r and omised or not to treatment , were included in analyses of incidence ; of these , 3642 were included in analyses of relative risk . Outcome measures : Primary predefined aggregate clinical outcomes : any end point or deaths related to diabetes and all cause mortality . Secondary aggregate outcomes : myocardial infa rct ion , stroke , amputation ( including death from peripheral vascular disease ) , and microvascular disease ( predominantly retinal photo-coagulation ) . Single end points : non-fatal heart failure and cataract extraction . Risk reduction associated with a 1 % reduction in up date d mean HbA1c adjusted for possible confounders at diagnosis of diabetes . Results : The incidence of clinical complications was significantly associated with glycaemia . Each 1 % reduction in up date d mean HbA1c was associated with reductions in risk of 21 % for any end point related to diabetes ( 95 % confidence interval 17 % to 24 % , P deaths related to diabetes ( 15 % to 27 % , P myocardial infa rct ion ( 8 % to 21 % , P microvascular complications ( 33 % to 41 % , P patients with type 2 diabetes the risk of diabetic complications was strongly associated with previous hyperglycaemia . Any reduction in HbA1c is likely to reduce the risk of complications , with the lowest risk being in those with HbA1c values in the normal range ( < 6.0 % )",
"BACKGROUND Disease management programs that include ongoing telephone support for patients with diabetes have shown promise , but published studies have enrolled few socially and economically disadvantaged patients . METHODS We conducted a r and omized controlled trial with 201 patients with poorly controlled type 2 diabetes mellitus ( 72 % African American or Latino ; 74 % with incomes of ≤$15,000 ) . Participants were r and omized to an intervention package consisting of a 24-minute video behavior support intervention with a workbook and 5 sessions of telephone coaching by a trained diabetes nurse or a 20-page brochure developed by the National Diabetes Education Program . Study measures were completed at baseline , 1 month , and 6 months . Participants ' review of the intervention material s was assessed at 1 month . The primary trial end point was hemoglobin A(1c ) value . Secondary end points included lipid levels , blood pressure , diabetes knowledge , and self-care behaviors . Data were analyzed with repeated measures analysis of variance . RESULTS Most participants in both groups ( 94 % ) review ed the intervention provided , and 73 % of participants assigned to the experimental group completed 5 sessions of telephone coaching . There was a significant overall reduction in mean ( SD ) hemoglobin A(1c ) value from baseline ( 9.6 % [ 2.0 % ] ) to 6 months ( 9.1 % [ 1.9 % ] ) ( P on other clinical measures ( lipid levels and blood pressure ) and measures of diabetes knowledge and self-care behaviors were also nonsignificant . CONCLUSIONS There was no significant effect of the experimental intervention compared with the control condition . The dose of intervention provided was less than in previously published studies . More intensive interventions may be necessary for the most disadvantaged patients . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00668590",
"BACKGROUND Group medical clinics ( GMCs ) are widely used in the management of diabetes and hypertension , but data on their effectiveness are limited . OBJECTIVE To test the effectiveness of GMCs in the management of comorbid diabetes and hypertension . DESIGN R and omized , controlled trial . ( Clinical Trials.gov registration number : NCT00286741 ) SETTING 2 Veterans Affairs Medical Centers in North Carolina and Virginia . PATIENTS 239 patients with poorly controlled diabetes ( hemoglobin A(1c ) [ HbA(1c ) ] level > or = 7.5 % ) and hypertension ( systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg ) . INTERVENTION Patients were r and omly assigned within each center to either attend a GMC or receive usual care . Clinics comprised 7 to 8 patients and a care team that consisted of a primary care general internist , a pharmacist , and a nurse or other certified diabetes educator . Each session included structured group interactions moderated by the educator . The pharmacist and physician adjusted medication to manage each patient 's HbA(1c ) level and blood pressure . MEASUREMENTS Hemoglobin A(1c ) level and systolic blood pressure , measured by blinded research personnel at baseline , study midpoint ( median , 6.8 months ) , and study completion ( median follow-up , 12.8 months ) . Linear mixed models , adjusted for clustering within GMCs , were used to compare HbA(1c ) levels and systolic blood pressure between the intervention and control groups . RESULTS Mean baseline systolic blood pressure and HbA(1c ) level were 152.9 mm Hg ( SD , 14.2 ) and 9.2 % ( SD , 1.4 ) , respectively . At the end of the study , mean systolic blood pressure improved by 13.7 mm Hg in the GMC group and 6.4 mm Hg in the usual care group ( P = 0.011 by linear mixed model ) , whereas mean HbA(1c ) level improved by 0.8 % in the GMC group and 0.5 % in the usual care group ( P = 0.159 ) . LIMITATION Measurements of effectiveness may have been limited by concomitant improvements in the usual care group that were due to co-intervention . CONCLUSION Group medical clinics are a potent strategy for improving blood pressure but not HbA(1c ) level in diabetic patients . PRIMARY FUNDING SOURCE U.S. Department of Veterans Affairs Health Services Research and Development Service",
"BACKGROUND Compared with white persons , African Americans have a greater incidence of diabetes , decreased control , and higher rates of microvascular complications . A peer mentorship model could be a scalable approach to improving control in this population and reducing disparities in diabetic outcomes . OBJECTIVE To determine whether peer mentors or financial incentives are superior to usual care in helping African American veterans decrease their hemoglobin A(1c ) ( HbA(1c ) ) levels . DESIGN A 6-month r and omized , controlled trial . ( Clinical Trials.gov registration number : NCT01125956 ) SETTING Philadelphia Veterans Affairs Medical Center . PATIENTS African American veterans aged 50 to 70 years with persistently poor diabetes control . INTERVENTION 118 patients were r and omly assigned to 1 of 3 groups : usual care , a peer mentoring group , and a financial incentives group . Usual care patients were notified of their starting HbA(1c ) level and recommended goals for HbA(1c ) . Those in the peer mentoring group were assigned a mentor who formerly had poor glycemic control but now had good control ( HbA(1c ) level ≤7.5 % ) . The mentor was asked to talk with the patient at least once per week . Peer mentors were matched by race , sex , and age . Patients in the financial incentive group could earn $ 100 by decreasing their HbA(1c ) level by 1 % and $ 200 by decreasing it by 2 % or to an HbA(1c ) level of 6.5 % . MEASUREMENTS Change in HbA(1c ) level at 6 months . RESULTS Mentors and mentees talked the most in the first month ( mean calls , 4 ; range , 0 to 30 ) , but calls decreased to a mean of 2 calls ( range , 0 to 10 ) by the sixth month . Levels of HbA(1c ) decreased from 9.9 % to 9.8 % in the control group , from 9.8 % to 8.7 % in the peer mentor group , and from 9.5 % to 9.1 % in the financial incentive group . Mean change in HbA(1c ) level from baseline to 6 months relative to control was -1.07 % ( 95 % CI , -1.84 % to -0.31 % ) in the peer mentor group and -0.45 % ( CI , -1.23 % to 0.32 % ) in the financial incentive group . LIMITATION The study included only veterans and lasted only 6 months . CONCLUSION Peer mentorship improved glucose control in a cohort of African American veterans with diabetes . PRIMARY FUNDING SOURCE National Institute on Aging Roybal Center",
"AIMS To investigate the effectiveness of a diabetes virtual clinic to enhance diabetes in primary care by developing clinical management plans for patients with suboptimal metabolic control and /or case complexity . METHODS A prospect i ve study with r and omized allocation to virtual clinic or usual care . Patients with Type 2 diabetes ( n = 208 ) were recruited from six general practice s in South London . The primary outcome for the study was glycaemic control , secondary outcomes included : lipids , blood pressure , weight ( kg and BMI ) and renal function ( eGFR ) . Data were collected from participants ' records at baseline and 12 months . We also considered process measures including therapy optimization . RESULTS The 12-month data show equivalence between the virtual clinic and control groups for glycaemic control with both achieving clinical ly significant reductions in HbA1c of 8 mmol/mol ( 0.6 ± 1.7 % ) and 10 mmol/mol ( 0.8 ± 1.9 % ) , respectively ( P = 0.4 ) . The virtual clinic group showed superiority over the intervention group for blood pressure control with a mean reduction in systolic blood pressure of 6 ± 16 mmHg compared with an increased of 2 ± 18 mmHg in the control group ( P = 0.008 ) . There were no significant differences between the groups in terms of cholesterol , weight and renal function . Process measures showed an increased level of therapy adjustment in the virtual clinic group . CONCLUSION The virtual clinic model explored in this study showed a clinical ly important improvement in glycaemic control . Although this improvement was not superior to that observed in the control participants , this might be attributable to the systemic impact of the virtual clinic on the practice as a whole",
"BACKGROUND Re source barriers complicate diabetes care management . Support from peers may help patients manage their diabetes . OBJECTIVE To compare a reciprocal peer-support ( RPS ) program with nurse care management ( NCM ) . DESIGN R and omized , controlled trial . ( Clinical Trials.gov registration number : NCT00320112 ) SETTING 2 U.S. Department of Veterans Affairs health care facilities . PATIENTS 244 men with hemoglobin A(1c ) ( HbA(1c ) ) levels greater than 7.5 % during the previous 6 months . MEASUREMENTS The primary outcome was 6-month change in HbA(1c ) level . Secondary outcomes were changes in insulin therapy ; blood pressure ; and patient reports of medication adherence , diabetes-related support , and emotional distress . INTERVENTION Patients in the RPS group attended an initial group session to set diabetes-related behavioral goals , receive peer communication skills training , and be paired with another age-matched peer patient . Peers were encouraged to talk weekly using a telephone platform that recorded call occurrence and provided reminders to promote peer contact . These patients could also participate in optional group sessions at 1 , 3 , and 6 months . Patients in the NCM group attended a 1.5-hour educational session and were assigned to a nurse care manager . RESULTS Of the 244 patients enrolled , 216 ( 89 % ) completed the HbA(1c ) assessment s and 231 ( 95 % ) completed the survey assessment s at 6 months . Mean HbA(1c ) level decreased from 8.02 % to 7.73 % ( change , -0.29 % ) in the RPS group and increased from 7.93 % to 8.22 % ( change , 0.29 % ) in the NCM group . The difference in HbA(1c ) change between groups was 0.58 % ( P = 0.004 ) . Among patients with a baseline HbA(1c ) level greater than 8.0 % , those in the RPS group had a mean decrease of 0.88 % , compared with a 0.07 % decrease among those in the NCM group ( between-group difference , 0.81 % ; P insulin therapy , compared with 1 patient in the NCM group ( P = 0.020 ) . Groups did not differ in blood pressure , self-reported medication adherence , or diabetes-specific distress , but the RPS group reported improvement in diabetes social support . LIMITATION The study included only male veterans and lasted only 6 months . CONCLUSION Reciprocal peer support holds promise as a method for diabetes care management",
"OBJECTIVE This study evaluated the efficacy of a nurse-care management system design ed to improve outcomes in patients with complicated diabetes . RESEARCH DESIGN AND METHODS In this r and omized controlled trial that took place at Kaiser Permanente Medical Center in Santa Clara , CA , 169 patients with longst and ing diabetes , one or more major medical comorbid conditions , and HbA(lc ) > 10 % received a special intervention ( n = 84 ) or usual medical care ( n = 85 ) for 1 year . Patients met with a nurse-care manager to establish individual outcome goals , attended group sessions once a week for up to 4 weeks , and received telephone calls to manage medications and self-care activities . HbA(lc ) , LDL , HDL , and total cholesterol , triglycerides , fasting glucose , systolic and diastolic blood pressure , BMI , and psychosocial factors were measured at baseline and 1 year later . Annualized physician visits were determined for the year before and during the study . RESULTS At 1 year , the mean reductions in HbA(lc ) , total cholesterol , and LDL cholesterol were significantly greater for the intervention group compared with the usual care group . Significantly more patients in the intervention group met the goals for HbA(1c ) ( psychosocial variables or in physician visits . CONCLUSIONS A nurse-care management program can significantly improve some medical outcomes in patients with complicated diabetes without increasing physician visits",
"Abstract .Practicing physicians as well as diabetes specialists are confronted with the often-frustrating experience of dealing with patients with poorly controlled diabetes . It is not always obvious why these patients fail to improve . The aims of this study were two-fold : ( a ) to determine if the interdisciplinary approach offered by the Western Negev Mobile Clinic Diabetes Program ( WNMDCP ) is of benefit in patients with poorly controlled type 2 diabetes and ( b ) to more fully characterize patients refractory to treatment . Two primary -care clinics of the Western Negev were r and omly selected as control and intervention . All patients from both clinics with hemoglobin ( HbA1C ) ≥10 % ( tested during June-July 2000 ) were studied for 6 months . Patients from the control clinic continued the usual treatment . Patients from the intervention clinic received the interdisciplinary approach offered by WNMCDP . The rate of improvement of diabetes control , measured as a decrease in HbA1C values of at least 0.5 % , and compliance to treatment were determined . Overall , 48 of 258 patients in the intervention clinic and 34 of 179 patients in the control clinic met the inclusion criteria . At the 6-month follow-up , we observed significant improvements in plasma glucose ( -1.5 mmol/l ; p=0.003 ) and HbA1C ( -1.8 % ; p=0.00001 ) in the intervention group but not in the control group . The compliance and response rates were 85 % and 71 % for the intervention group and 32 % and 35 % for the control group , respectively . Patients from the intervention clinic showed significant improvement in the endpoints compared to patients from the control clinic . More than 70 % of patients with poorly controlled diabetes mellitus responded to the interdisciplinary treatment approach offered by WNMDCP . The group of non-responders comprised patients with poor compliance ( 15 % ) and those with serious concomitant diseases or limitations of mobility",
"BACKGROUND We evaluated how a structured patient/physician self-monitoring of blood glucose ( SMBG ) intervention influenced the timing , frequency , and effectiveness of primary care physicians ' treatment changes with type 2 diabetes mellitus ( T2DM ) patients over 12 months . METHODS The Structured Testing Program ( STeP ) study was a cluster-r and omized , multicenter trial with 483 poorly controlled , insulin-naive T2DM subjects . Primary care practice s were r and omized to the Active Control Group ( ACG ) or the Structured Testing Group ( STG ) , the latter of which included quarterly review of structured SMBG results . STG patients used a paper tool that graphs seven-point glucose profiles over 3 consecutive days ; physicians received a treatment algorithm based on SMBG patterns . Impact of structured SMBG on physician treatment modification recommendations ( TMRs ) and glycemic outcomes was examined . RESULTS More STG than ACG patients received a TMR at each study visit ( P greater reduction in glycated hemoglobin A1c ( HbA1c ) than ACG patients ( -1.2 % vs. -0.8 % , P baseline HbA1c ≥8.5 % who received a TMR at the Month 1 visit experienced greater reductions in HbA1c ( P = 0.002 ) than patients without an initial TMR . More STG than ACG patients were started on incretins ( P on thiazolidinediones ( P = 0.004 ) . The number of visits with a TMR was unrelated to HbA1c change over time . CONCLUSIONS Patient-provided SMBG data contribute to glycemic improvement when blood glucose patterns are easy to detect , and well-trained physicians take timely action . Collaborative use of structured SMBG data leads to earlier , more frequent , and more effective TMRs for poorly controlled , non-insulin-treated T2DM subjects",
"OBJECTIVES To demonstrate that pharmacists working with physicians and other providers in an ambulatory care setting can improve glucose , blood pressure , and lipid control for patients with type 2 diabetes and to report patient adherence to screening and general preventive measures . DESIGN Prospect i ve , r and omized , clinical practice study . SETTING Burlington , MA , between January 2001 and August 2003 . PATIENTS 164 patients patients with type 2 diabetes older than 18 years with glycosylated hemoglobin ( A1C ) greater than 8 % . INTERVENTION Pharmacist-patient clinic visits included obtaining a comprehensive medication review ; performing targeted physical assessment ; ordering laboratory tests ; review ing , modifying , and monitoring patients ' medication therapy and providing detailed counseling on all therapies ; facilitating self-monitoring of blood glucose ; and providing reinforcement of dietary guidelines and exercise . MAIN OUTCOME MEASURE Effect of clinical pharmacists working with physicians in an ambulatory setting on health measures ( e.g. , A1C , blood pressure , cholesterol ) of patients with diabetes . RESULTS Baseline characteristics were similar between the two groups . After 1 year , significant improvements occurred for A1C and low-density lipoprotein ( LDL ) cholesterol in the intervention group compared with the control group ( A1C , 7.7 % vs. 8.4 % ; LDL , 93.7 vs. 105.1 mg/dL ; P Systolic blood pressure improved for all study patients without a difference between the two groups . Diastolic blood pressure improved significantly in the intervention group compared with the control group ( 73.4 mm Hg vs. 77.6 mm Hg , P retinopathy , neuropathy , and microalbuminuria than control patients ( P < 0.05 ) . CONCLUSION For all indices measured , this study demonstrated that collaborative diabetes management with a clinical pharmacist can improve overall care",
"Objectives This r and omized controlled trial investigated whether a patient-centered supportive counseling intervention comprising monthly telephone-based counseling sessions by practice nurses over 12 months improved diabetes-related medical and psycho-social outcomes above usual care in type 2 diabetes patients with poor glycemic control at baseline ( HbA1c > 7.5 % ) in a primary care setting . Research Design Patients were individually r and omized into intervention ( n = 103 ) and usual care group ( n = 101 ) . The primary outcome was change in HbA1c-concentration after 12 and 18 months . Secondary outcomes were lipid levels , blood pressure , health-related quality of life and symptoms of depression . Follow-up- measurements were carried out after 6 , 12 and 18 months to assess potential immediate and maintained effects of the intervention . For the multivariate analysis , hierarchical linear models were computed for each outcome to assess within-group changes in outcomes over time and between-group differences in patterns of change . Results HbA1c ( in % ) decreased significantly from baseline to 12-month follow-up measurement both in the intervention ( −0.44 ) and the usual care group ( −0.51 ) , but there was no significant between-group intervention effect . Significant improvements in the intervention group along with significant between-group differences were seen for health-related quality of life and , transiently , for systolic blood pressure and depression . Conclusions Although we found no beneficial effect of the supportive telephone counseling in terms of a reduction of HbA1c above usual care , our findings suggest some beneficial effects on cardiovascular risk factors , quality of life and depression . Continuous efforts might be needed to sustain improvements in patient outcomes . Trial Registration Clinical Trials.gov",
"OBJECTIVE Disparities exist in the diabetes health status of ethnic minority and /or low-income population s relative to other groups . A primary objective of diabetes management is to improve glycemic control . The feasibility of implementing intensive diabetes case management in disparate population s remains largely untested . RESEARCH DESIGN AND METHODS Clinical sites in three southern California counties serving low-income , ethnic minority population s participated in our study . We r and omized 362 Medicaid ( called Medi-Cal in California ) recipients with type 2 diabetes for at least 1 year to intervention ( diabetes case management ) or control ( traditional primary care treatment ) groups . Fifty-five percent of participants were minorities . Participants with HbA(1c ) levels less than 7.5 % , serious diabetes-related complications , or other serious medical conditions were excluded . We assessed the effect of the intervention ( ongoing diabetes case management added to primary care ) on glycemic control using serial HbA(1c ) measurements over several years . RESULTS The mean duration of follow-up was 25.3 months . HbA(1c ) decreased substantially in both groups from an average of 9.54 - 7.66 % ( a reduction of 1.88 % ) in the intervention group and from an average of 9.66 - 8.53 % ( a reduction of 1.13 % ) in the control group . This improvement was sustained throughout the study . The reduction in HbA(1c ) was consistently greater in the intervention group at each time point ( P Diabetes case management , added to primary care , substantially improved glycemic control compared with the control group . Diabetes case management can help reduce disparities in diabetes health status among low-income ethnic population",
"PURPOSE To assess the efficacy of a pharmacist-led , primary care-based , disease management program to improve cardiovascular risk factors and glycated hemoglobin ( A(1C ) ) levels in vulnerable patients with poorly controlled diabetes . METHODS A r and omized controlled trial of 217 patients with type 2 diabetes and poor glycemic control ( A(1C ) level > or=8.0 % ) was conducted at an academic general medicine practice from February 2001 to April 2003 . Intervention patients received intensive management from clinical pharmacists , as well as from a diabetes care coordinator who provided diabetes education , applied algorithms for managing glucose control and decreasing cardiovascular risk factors , and addressed barriers to care . Control patients received a one-time management session from a pharmacist followed by usual care from their primary care provider . Outcomes were recorded at baseline and at 6 and 12 months . Primary outcomes included blood pressure , A(1C ) level , cholesterol level , and aspirin use . Secondary outcomes included diabetes knowledge , satisfaction , use of clinical services , and adverse events . RESULTS For the 194 patients ( 89 % ) with 12-month data , the intervention group had significantly greater improvement than did the control group for systolic blood pressure ( -9 mm Hg ; 95 % confidence interval [ CI ] : -16 to -3 mm Hg ) and A(1C ) level ( -0.8 % ; 95 % CI : -1.7 % to 0 % ) . Change in total cholesterol level was not significant . At 12 months , aspirin use was 91 % in the intervention group versus 58 % among controls ( P diabetes knowledge and satisfaction than did control patients . There were no significant differences in use of clinical services or adverse events . CONCLUSION Our comprehensive disease management program reduced cardiovascular risk factors and A(1C ) levels among vulnerable patients with type 2 diabetes and poor glycemic control",
"OBJECTIVE To test trial design issues related to measuring the effectiveness of a peer telephone intervention to enhance self-efficacy in type 2 diabetes ; evaluate the impact on self-efficacy and clinical outcome ; and describe patient and peer experience . METHODS Eligible patients had raised HbA1c ( initial threshold > 8 % , reduced to > 7.4 % mid-way through trial ) . Patients were recruited from 40 general practice s and r and omised ( 40:40:20 ratio ) to receive routine care alone or , in addition , motivational telephone support from a peer supporter or a diabetes specialist nurse ( 9 peers and 12 DSNs ) for a period of up to 6 months . The primary outcome measure was self-efficacy score , and secondary outcome measures included HbA1c . Patient and telecare supporter satisfaction and experience were evaluated . RESULTS In all , 231 patients participated . At 6 months there were no statistically significant differences in self-efficacy scores ( p=0.68 ) , HbA1c ( p=0.87 ) or other secondary outcome measures . There was evidence of a high level of acceptability , but peer telecare support was less highly valued than that from a DSN . Some patients stated that they would have valued more information and advice . CONCLUSIONS Further consideration needs to be given to the targeting of the telecare peer support , its intensity , the training and ongoing supervision of peer supporters , and the extent to which information and advice should be incorporated . PRACTICE IMPLICATION S While some patients with poorly controlled type 2 diabetes value peer telephone support , this approach appears not to suit all patients . Further intervention development and evaluation is required before widespread adoption can be recommended",
"Diabetes is defined by its association with hyperglycemia-specific microvascular complications ; however , it also imparts a two- to fourfold risk of cardiovascular disease ( CVD ) . Although microvascular complications can lead to significant morbidity and premature mortality , by far the greatest cause of death in people with diabetes is CVD . Results from r and omized controlled trials have demonstrated conclusively that the risk of microvascular complications can be reduced by intensive glycemic control in patients with type 1 ( 1,2 ) and type 2 diabetes ( 3–5 ) . In the Diabetes Control and Complications Trial ( DCCT ) , there was an ∼60 % reduction in development or progression of diabetic retinopathy , nephropathy , and neuropathy between the intensively treated group ( goal A1C glucose control ( as reflected by the mean on- study A1C value ) and risk of complications was log-linear and extended down to the normal A1C range ( Prospect i ve Diabetes Study ( UKPDS ) , participants newly diagnosed with type 2 diabetes were followed for 10 years , and intensive control ( median A1C 7.0 % ) was found to reduce the overall microvascular complication rate by 25 % compared with conventional treatment ( median A1C 7.9 % ) . Here , too , secondary analyses showed a continuous relationship between the risk of microvascular complications and glycemia extending into the normal range of A1C , with no glycemic threshold . On the basis of these two large controlled trials , along with smaller studies and numerous epidemiologic reports , the consistent findings related to microvascular risk reduction with intensive glycemic control have led the American Diabetes Association ( ADA ) to recommend an A1C goal of < 7 % for most adults with diabetes ( 6 ) , recognizing that more or less stringent goals may be appropriate for certain patients . Whereas many epidemiologic studies and meta-analyses"
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Study design : A systematic review . Objectives : The aim of this systematic review was to establish whether combined aerobic training and muscle strength training is effective in improving aerobic fitness , muscle strength , function and /or quality of life ( QoL ) in people with spinal cord injury ( SCI ) . Setting s : Faculty of Health Sciences . University of Sydney , NSW , Australia . Methods : A search was conducted for r and omized controlled trials ( RCTs ) , controlled trials , uncontrolled clinical trials , case series and cross-over studies involving exercise interventions that included a combination of aerobic and strength components , either in circuit-mode or in sequence for people with SCI . Method ological quality was independently rated using the PEDro scale and key findings were extracted from trials by two review ers . Results : The search identified 7981 abstract s , from which nine trials met the inclusion criteria . From the nine selected trials , seven reported aerobic outcomes , two of which showed a statistically significant within-group difference in aerobic fitness . Five studies reported muscle strength outcomes , four of them showed a statistically significant within-group mean difference on at least one outcome measure . Two studies looked at QoL , one of them found a statistically significant between-group difference on one outcome measure . Conclusion : Our systematic review showed that literature on SCI population is scarce , of low quality and findings of existing studies are inconsistent . Thus , further RCTs with larger number of participants are needed to make a definite conclusion about the influence of combined aerobic and muscle strength training on aerobic fitness , muscle strength and QoL in people with SCI
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"Evidence -based practice involves the use of evidence from systematic review s and r and omised controlled trials , but the extent of this evidence in physiotherapy has not previously been surveyed . The aim of this survey is to describe the quantity and quality of r and omised controlled trials and the quantity of systematic review s relevant to physiotherapy . The Physiotherapy Evidence Data base ( PEDro ) was search ed . The quality of trials was assessed with the PEDro scale . The search identified a total of 2,376 r and omised controlled trials and 332 systematic review s. The first trial was published in 1955 and the first review was published in 1982 . Since that time , the number of trials and review s has grown exponentially . The mean PEDro quality score has increased from 2.8 in trials published between 1955 and 1959 to 5.0 for trials published between 1995 and 1999 . There is a substantial body of evidence about the effects of physiotherapy . However , there remains scope for improvements in the quality of the conduct and reporting of clinical trials",
"OBJECTIVE To examine the effects of circuit resistance exercise ( CRT ) training on muscle strength , endurance , anaerobic power , and shoulder pain in middle-aged men with paraplegia . DESIGN Repeated testing . SETTING Academic medical center . PARTICIPANTS Seven men ( age range , 39 - 58y ) with motor-complete paraplegia from T5 to T12 and confirmed shoulder pain occurring during daily activities . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Subjects underwent a 4-month CRT program using alternating resistance maneuvers and high-speed , low-resistance arm exercise . One-repetition maximal force was measured before training and monthly thereafter . Pretraining and posttraining peak oxygen uptake ( Vo(2)peak ) was measured by grade d arm testing . Anaerobic power was measured before and after training using a 30-second Wingate Anaerobic Test . Shoulder pain was self-evaluated by an index vali date d for people with spinal cord injury ( Wheelchair Users Shoulder Pain Index [ WUSPI ] ) . RESULTS Strength increases ranging from 38.6 % to 59.7 % were observed for all maneuvers ( P range , .005-.008 ) . Vo(2)peak increased after training by 10.4 % ( P=.01 ) , and peak and average anaerobic power increased by 6 % ( P=.001 ) and 8.6 % ( P=.005 ) , respectively . WUSPI scores + /- st and ard deviation were lowered from 31.9+/-24.8 to 5.7+/-5.9 ( P=.008 ) , with 3 of 7 subjects reporting complete resolution of shoulder pain . CONCLUSIONS CRT improves muscle strength , endurance , and anaerobic power of middle-aged men with paraplegia while significantly reducing their shoulder pain",
"Study design : Retrospective analysis . Objectives : The objectives of this research were to , in subjects with lower cervical spinal cord injury ( SCI ) , examine the relationship between strength of muscle groups as measured by the manual muscle test ( MMT ) and function ( reflected as burden of care ) as measured by individual functional independence measure ( FIM ) motor tasks , and investigate the extent to which MMT scores explain the variance of the motor FIM scores . Setting : Acute rehabilitation hospitals , Boston , MA , USA . Methods : Retrospective pilot study of 20 in- patients , age 18–62 years , with an SCI between C5 and C7 . Discharge demographic variables , MMT and motor FIM scores were analyzed . Descriptive statistics , Spearman 's rank correlation coefficients , stepwise regressions were performed . Results : MMT scores for elbow flexion followed by shoulder flexion and wrist extension correlated with the greatest number of FIM tasks . MMT scores explained some part of the variance in the eight of 12 motor FIM tasks . In six of eight tasks , one key muscle explained a large portion of the variance . Conclusion : Key muscles relative to FIM tasks can be identified . These findings may help focus therapeutic interventions aim ed at achievement in these tasks"
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Attention-deficit/hyperactivity disorder ( ADHD ) is a common disorder of childhood that often persists into adulthood . Although stimulant medications are recommended as the first-line treatment for ADHD because of their documented short-term effects in children and adults , less is known about their effects on long-term outcome in adults . Here we review the long-term efficacy and safety of the stimulant drugs methylpheni date and amphetamine , as well as the related compound atomoxetine . We performed a systematic review to identify direct and indirect effects of stimulant therapy on long-term outcome in adults . Five r and omized controlled trials ( RCTs ) , and 10 open-label extension studies of initial short-term RCTs , with total follow-up of at least 24weeks , were identified . All these RCTs found that medication was significantly more efficacious than placebo in treating ADHD in adults , and the extension studies showed that this favorable effect of medication was maintained during the open-label follow-up period . However , since the maximum duration of these pharmacological trials was 4years , we also review ed 18 defined naturalistic longitudinal and cross-sectional studies , to provide more information about longer term functional outcomes , side effects and complications . These observational studies also showed positive correlations between early recognition of the disorder , stimulant treatment during childhood and favorable long-term outcome in adult ADHD patients . In conclusion , stimulant therapy of ADHD has long-term beneficial effects and is well tolerated . However , more longitudinal studies of long duration should be performed . In addition , the ethical issues involved in performing double blind RCTs of many years duration should be further explored
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"Methylpheni date ( MPH ) is widely prescribed for adults with attention deficit hyperactivity disorder ( ADHD ) , but data on long-term treatment and maintenance of effect are lacking . Osmotic release oral system-methylpheni date ( OROS – MPH ) was evaluated in a 52-wk open-label study in subjects who had previously completed a short-term placebo-controlled trial and short-term open-label extension . Efficacy was assessed using the investigator- and subject-rated Conners ’ Adult ADHD Rating Scales ( CAARS : O-SV and CAARS : S-S ) , and the Clinical Global Impression – Severity ( CGI-S ) , Sheehan Disability Scale ( SDS ) and Quality of Life Enjoyment and Satisfaction Question naire ( Q-LES-Q ) . Subjects completing ≥52 wk of treatment were eligible for a 4-wk r and omized , placebo-controlled withdrawal phase in which loss of treatment effect was assessed using CAARS : O-SV and CGI-S. In the open-label phase ( n=156 ) , mean CAARS : O-SV score decreased from baseline by 1.9±7.8 ( p for CAARS : S-S , CGI-S and SDS . In the double-blind phase ( OROS-MPH , n=23 ; placebo , n=22 ) , CAARS : O-SV increased from double-blind baseline in the OROS-MPH and placebo arms ( 4.0±7.6 vs. 6.5±7.8 , not statistically significant ) . Long-term OROS-MPH treatment was well tolerated , and there was no evidence of withdrawal or rebound after discontinuation . In conclusion , the short-term benefits of OROS-MPH continue during long-term open-label treatment . Maintenance of efficacy in a placebo-controlled withdrawal design remains to be confirmed in larger patient population",
"OBJECTIVE : Little is known about the effect of stimulant treatment in youth with attention-deficit/hyperactivity disorder ( ADHD ) on the subsequent development of comorbid psychiatric disorders . We tested the association between stimulant treatment and the subsequent development of psychiatric comorbidity in a longitudinal sample of patients with ADHD . METHODS : We conducted a case-control , 10-year prospect i ve follow-up study into young-adult years of youth with ADHD . At baseline , we assessed consecutively referred white male children with ( n = 140 ) and without ( n = 120 ) ADHD , aged 6 to 18 years . At the 10-year follow-up , 112 ( 80 % ) and 105 ( 88 % ) of the children in the ADHD and control groups , respectively , were reassessed ( mean age : 22 years ) . We examined the association between stimulant treatment in childhood and adolescence and subsequent comorbid disorders and grade retention by using proportional hazards survival models . RESULTS : Of the 112 participants with ADHD , 82 ( 73 % ) were previously treated with stimulants . Participants with ADHD who were treated with stimulants were significantly less likely to subsequently develop depressive and anxiety disorders and disruptive behavior and less likely to repeat a grade compared with participants with ADHD who were not treated . CONCLUSIONS : We found evidence that stimulant treatment decreases the risk for subsequent comorbid psychiatric disorders and academic failure in youth with ADHD",
"There is increased global recognition of attention deficit hyperactivity disorder ( ADHD ) as a serious medical condition with long-term consequences . Although originally conceived of as a childhood disorder , ADHD is being increasingly recognized in adults . Individual geographic regions may have specific interests and objectives for the study of ADHD . A systematic review of long-term outcomes ( LTOs ) in ADHD was conducted to evaluate research on ADHD LTOs on a global scale . Studies that were at least 2 years in duration were examined . A total of 351 studies were identified in the final analysis . We identified nine outcomes of interest and classified studies by specific geographical regions , age groups studied and study design by region and over time . Published studies of LTOs in ADHD have increased in all geographical regions over the past three decades , with a peak number of 42 publications in 2008 . This rise in publications on ADHD LTOs may reflect a rise in global interest and recognition of consequences and impairment associated with ADHD . Although many world regions have published on ADHD LTOs , the majority of studies have emerged from the US and Canada , followed by Europe . While investigators in the US and Canada were predominantly interested in drug addiction as a LTO , European research ers were more interested in antisocial behavior , and Eastern Asian investigators focused on both of these LTOs as well as self-esteem . Geographical differences in the focus of ADHD LTO studies may reflect regional variations in cultural values . Proportionally fewer prospect i ve longitudinal studies and proportionally more retrospective and cross-sectional studies have been published in more recent decades . Finally , more studies focusing on ADHD in adolescents and adults have been conducted in recent years , and particularly adolescents in Eastern Asia . These changes in basic study design may reflect an increase in the recognition that ADHD is a lifetime chronic disorder . This systematic review analysis of publication trends in ADHD LTOs reflects geographically based interests that change over time",
"Objective : To evaluate the long-term safety of OROS methylpheni date in the management of attention-deficit/hyperactivity disorder ( ADHD ) in adults . Methods : This multicenter , open-label , dose-titration , flexible dose study enrolled adults with ADHD for 6 or 12 months of treatment with OROS methylpheni date . Dosing began at 36 mg/d , with titration in 18-mg increments every 7 days until a predefined outcome ( efficacy threshold , maximum dosage of 108 mg/d , or limiting adverse event ) . Dose reduction occurred for prespecified reasons , and the subjects discontinued if unable to tolerate 36 mg/d . Assessment s included ADHD symptoms , adverse events , vital signs , and laboratory results . Results : A total of 550 subjects received treatment ( 52 % were men ; mean age , 39 years ; range , 18 - 65 years ) , and 57 % ( 146/258 ) and 44 % ( 129/292 ) completed their 6 or 12 months of treatment with mean duration s of 128 and 213 days , respectively . The final prescribed dosages were 36 mg/d ( 22.4 % ) , 54 mg/d ( 25.1 % ) , 72 mg/d ( 22.0 % ) , 90 mg/d ( 17.1 % ) , and 108 mg/d ( 13.5 % ) . Modest increases from baseline to final visit were observed in mean systolic ( 2.6 mm Hg ) and diastolic ( 1.9 mm Hg ) blood pressure and pulse ( 4.1 beats per minute ) . The mean weight decreased by 2.3 kg . No clinical ly meaningful changes in laboratory values or electrocardiogram parameters were observed other than increased heart rate . Most common adverse events included decreased appetite ( 26.7 % ) , headache ( 24.0 % ) , and insomnia ( 20.7 % ) . No serious adverse event was considered related to study medication . Several measures of efficacy indicated improvement during the study . Conclusions : OROS methylpheni date , in the flexible dosage range from 36 to 108 mg/d , was well tolerated for up to 1 year in adults with ADHD",
"BACKGROUND Attention-deficit hyperactivity disorder ( ADHD ) is highly prevalent in prison inmates , but pharmacological treatment has not yet been evaluated in this group . AIMS To evaluate osmotic-release oral system ( OROS ) methylpheni date in adult male long-term prison inmates with ADHD . METHOD R and omised , double-blind , placebo-controlled 5-week trial , followed by 47-week open-label extension in 30 prison inmates with ADHD and comorbid disorders . Primary outcome was level of ADHD symptoms after 5 weeks , evaluated by a masked assessor . Secondary outcomes were self-reported ADHD symptoms , global severity and global functioning throughout the 52-week trial , and post hoc treatment response and numbers needed to treat ( NNT ) ( trial registration : NCT00482313 . ) RESULTS Treatment significantly improved ADHD during the trial ( P reduced symptom severity and improved global functioning . The placebo response , cardiovascular measures and adverse events were non-significant ; the NNT was 1.1 . Attention-deficit hyperactivity disorder symptoms , global severity and global functioning continued to improve during the open-label extension . CONCLUSIONS Osmotic-release oral system methylpheni date is an effective treatment for adult male prison inmates with ADHD",
"Abstract Objectives . Treatment investigations with methylpheni date in adults with ADHD focus preferentially on the classical psychopathology : inattention , hyperactivity and impulsivity . ADHD-associated emotional symptoms , which are frequently present at least in ADHD sub population s , were studied rarely . The vast majority of the placebo-controlled trials had observation periods between 4 and 8 weeks . To assess the medium- to long-term effects of extended release methylpheni date ( MPH-ER ) on emotional symptoms and other psychopathology frequently seen in ADHD patients , we conducted a large-scale , multicenter treatment study . Methods . We performed a r and omised , 24-week , double-blind , placebo-controlled study in adults with ADHD . The diagnosis was made on the basis of the DSM-IV criteria , which were confirmed by clinical history and a structured psychopathological interview and the use of rating instruments . 363 patients were r and omized to MPH-ER or placebo at a ratio of 2:1 . The duration of the titration period was 5 weeks followed by a maintainance phase of 19 weeks . The efficacy measures were the observer rated 10-item Emotional Dysregulation Scale ( EDS ) derived from the Wender-Reimherr Adult Attention Deficit Disorder Scale ( WRAADDS ) and a self-report , six-item Emotional Lability Scale ( ELS ) extracted from the long version of the Conners Adult ADHD Self Report Scale ( CAARS : S : L ) . In addition we used the SCL-90-R for the assessment of ADHD associated and comorbid psychopathology . Results . MPH-ER was statistically superior to placebo in reducing emotional symptoms as assessed by the EDS and the ELS . Obsessive-compulsive symptoms and those of problems with self-concept declined until the end of the observation period . The decline was more pronounced in MPH-ER treated individuals . The effects remained robust during the entire maintenance period until week 24 . Symptoms of anxiety , depression , anger and hostility , phobia , paranoid ideations and psychoticism were not improved . Conclusions . MPH-ER appears to be an efficacious treatment for emotional symptoms with ADHD . Also obsessive-compulsive symptoms and problems with self-concept were affected positively",
"Treatment with psychostimulant medication has been shown to improve scholastic functioning in children with attention-deficit/hyperactivity disorder ( ADHD ) . However , the extent to which long-term academic gains are apparent in those having received such treatment remains elusive . This study examined prospect ively the relationship of childhood stimulant treatment to academic functioning during adolescence . Children ( n = 169 ) were initially recruited and diagnosed with ADHD when they were 7 - 11 years old . A sub sample of those with childhood ADHD ( n = 90 ) was reevaluated on average 9.13 ( SD = 1.5 ) years later . Prob and s who did and did not receive treatment with stimulant medication were compared to each other and to a never-ADHD comparison group ( n = 80 ) on three subtests from the Wechsler Individual Achievement Test-II ( WIAT-II ) , as well as high school grade point average ( GPA ) and number of retentions in school as derived from school records . Analyses of covariance controlling for severity of childhood ADHD symptoms indicated that prob and s treated with psychostimulant medication achieved better academic outcomes , as measured by WIAT-II subtests and high school GPA , than those not treated with psychostimulants ( p Psychostimulant treatment for children with ADHD may benefit long-term adolescent academic performance , although the extent of improvement is likely to vary as a function of multiple factors",
"OBJECTIVES To determine any long-term effects , 6 and 8 years after childhood enrollment , of the r and omly assigned 14-month treatments in the NIMH Collaborative Multisite Multimodal Treatment Study of Children With Attention-Deficit/Hyperactivity Disorder ( MTA ; N = 436 ) ; to test whether attention-deficit/hyperactivity disorder ( ADHD ) symptom trajectory through 3 years predicts outcome in subsequent years ; and to examine functioning level of the MTA adolescents relative to their non-ADHD peers ( local normative comparison group ; N = 261 ) . METHOD Mixed-effects regression models with planned contrasts at 6 and 8 years tested a wide range of symptom and impairment variables assessed by parent , teacher , and youth report . RESULTS In nearly every analysis , the originally r and omized treatment groups did not differ significantly on repeated measures or newly analyzed variables ( e.g. , grade s earned in school , arrests , psychiatric hospitalizations , other clinical ly relevant outcomes ) . Medication use decreased by 62 % after the 14-month controlled trial , but adjusting for this did not change the results . ADHD symptom trajectory in the first 3 years predicted 55 % of the outcomes . The MTA participants fared worse than the local normative comparison group on 91 % of the variables tested . CONCLUSIONS Type or intensity of 14 months of treatment for ADHD in childhood ( at age 7.0 - 9.9 years ) does not predict functioning 6 to 8 years later . Rather , early ADHD symptom trajectory regardless of treatment type is prognostic . This finding implies that children with behavioral and sociodemographic advantage , with the best response to any treatment , will have the best long-term prognosis . As a group , however , despite initial symptom improvement during treatment that is largely maintained after treatment , children with combined-type ADHD exhibit significant impairment in adolescence . Innovative treatment approaches targeting specific areas of adolescent impairment are needed",
"OBJECTIVE The extant literature does not provide definite answers pertaining to whether stimulant treatment increases , decreases , or does not affect the risk for subsequent substance use disorders in youths with attention deficit hyperactivity disorder ( ADHD ) . The authors examined the association between stimulant treatment in childhood and adolescence and subsequent substance use disorders ( alcohol , drug , and nicotine ) into the young adult years . METHOD The authors conducted a 10-year prospect i ve follow-up study . One hundred forty male Caucasian children with ADHD , ages 6 to 17 , were examined at baseline . Of these , 112 ( 80 % ) were reassessed at the 10-year follow-up ( mean age at follow-up=22 years ) . Assessment s were made using Cox proportional hazards survival models . All models were adjusted for conduct disorder , since conduct disorder is a potent predictor of subsequent substance use disorders . RESULTS Of the 112 ADHD subjects who were reassessed at the 10-year follow-up , 82 ( 73 % ) had been treated previously with stimulants and 25 ( 22 % ) were undergoing stimulant treatment at the time of the follow-up assessment . There were no statistically significant associations between stimulant treatment and alcohol , drug , or nicotine use disorders . CONCLUSIONS The findings revealed no evidence that stimulant treatment increases or decreases the risk for subsequent substance use disorders in children and adolescents with ADHD when they reach young adulthood",
"BACKGROUND [ corrected ] Attention-deficit/hyperactivity disorder ( ADHD ) has been less studied in adults than in children , and the treatment studies reported to date have been small , single-center trials . To assess the efficacy of atomoxetine , a new and highly selective inhibitor of the norepinephrine transporter , we conducted two large , multicenter treatment trials . METHODS Two identical studies using r and omized , double-blind , placebo-controlled design s and a 10-week treatment period were conducted in adults with DSM-IV-defined ADHD as assessed by clinical history and confirmed by a structured interview ( study I , n = 280 ; study II , n = 256 ) . The primary outcome measure was a comparison of atomoxetine and placebo using repeated measures mixed model analysis of postbaseline values of the Conners ' Adult ADHD Rating Scale . RESULTS In each study , atomoxetine was statistically superior to placebo in reducing both inattentive and hyperactive and impulsive symptoms as assessed by primary and secondary measures . Discontinuations for adverse events among atomoxetine patients were under 10 % in both studies . CONCLUSION Atomoxetine appears to be an efficacious treatment for adult ADHD . Its lack of abuse potential may be an advantage for many patients",
"Objective : To determine the effects of long-term methylpheni date treatment on symptom severity and social adjustment in adult ADHD . Method : Adults ( n = 116 ) meeting operational diagnostic criteria for ADHD ( the “ Utah Criteria ” ) entered a r and omized double-blind crossover trial of methylpheni date and placebo . Participants who improved on immediate-release methylpheni date entered a 12-month , open-label trial . Outcomes were assessed using the Wender-Reimherr Adult Attention Deficit Disorder Scale ( WRAADDS ) , Clinical Global Impression — Improvement ( CGI-I ) , global assessment of functioning ( GAF ) , and the Weissman Social Adjustment Scale ( WSAS ) . Results : In the double-blind trial more patients improved ( 50 % reduction of symptoms ) receiving methylpheni date ( 74 % ) than placebo ( 21 % , p = .001 ) . During the open-label trial , symptom severity decreased 80 % from baseline , and the WSAS decreased > 50 % in all subscales . The average GAF improved significantly ( p ADHD adults , who responded to methylpheni date in a short-tem , placebo-controlled trial , responded to long-term treatment with marked improvements in ADHD symptoms and psychosocial functioning ",
"BACKGROUND This open-label trial followed a previously reported r and omized , placebo-controlled trial of osmotic release oral system ( OROS ) methylpheni date ( MPH ) for the treatment of personality disorder ( PD ) . Important findings from the double-blind phase are reexamined for long-term significance . METHODS Of 41 patients who completed the double-blind , placebo-controlled trial , 34 continued into this open-label phase . The Wender-Reimherr Adult Attention Deficit Disorder Scale ( WRAADDS ) measured outcome . Patients were categorized using previously defined attention-deficit/hyperactivity disorder ( ADHD ) groups : ADHD alone , ADHD with emotional dysregulation ( ADHD + ED ) , and ADHD plus emotional dysregulation plus oppositional symptoms ( ADHD + ED + ODD ) ; and 3 post hoc personality categories : patients with no PD ( PD-negative ) , patients with 1 PD ( PD-positive ) , and patients meeting criteria for 2 or more PDs ( PD-plus ) . RESULTS Three WRAADDS-defined ADHD dimensions improved at similar levels ( attention + disorganization , 61 % ; hyperactivity + impulsivity , 60 % ; and emotional dysregulation , 66 % ) . All ADHD subgroups ( ADHD alone , ADHD + ED , and ADHD + ED + ODD ) improved . ADHD + ED + ODD patients had the highest level of social maladjustment at baseline and showed the most long-term improvement in this area . PD-plus patients were less likely to complete the study or show improvement . Sixty-five percent of treatment responders were on moderate doses ( OROS MPH . Vital signs and ECGs did not differ from baseline . CONCLUSIONS Eighteen ( 44 % ) patients completed the trial . All 3 ADHD dimensions showed similar , well-maintained improvement . Patients with several PDs responded poorly to treatment in this small trial",
"BACKGROUND Our objective was to estimate the lifetime prevalence of psychopathology in a sample of youth with and without attention deficit hyperactivity disorder ( ADHD ) through young adulthood using contemporaneous diagnostic and analytic techniques . METHOD We conducted a case-control , 10-year prospect i ve study of ADHD youth . At baseline , we assessed consecutively referred male , Caucasian children with ( n=140 ) and without ( n=120 ) DSM-III-R ADHD , aged 6 - 18 years , ascertained from psychiatric and pediatric sources to allow for generalizability of results . At the 10-year follow-up , 112 ( 80 % ) and 105 ( 88 % ) of the ADHD and control children , respectively , were reassessed ( mean age 22 years ) . We created the following categories of psychiatric disorders : Major Psychopathology ( mood disorders and psychosis ) , Anxiety Disorders , Antisocial Disorders ( conduct , oppositional-defiant , and antisocial personality disorder ) , Developmental Disorders ( elimination , language , and tics disorder ) , and Substance Dependence Disorders ( alcohol , drug , and nicotine dependence ) , as measured by blinded structured diagnostic interview . RESULTS The lifetime prevalence for all categories of psychopathology were significantly greater in ADHD young adults compared to controls , with hazard ratios and 95 % confidence intervals of 6.1 ( 3.5 - 10.7 ) , 2.2 ( 1.5 - 3.2 ) , 5.9 ( 3.9 - 8.8 ) , 2.5 ( 1.7 - 3.6 ) , and 2.0 ( 1.3 - 3.0 ) , respectively , for the categories described above . CONCLUSIONS By their young adult years , ADHD youth were at high risk for a wide range of adverse psychiatric outcomes including markedly elevated rates of antisocial , addictive , mood and anxiety disorders . These prospect i ve findings provide further evidence for the high morbidity associated with ADHD across the life-cycle and stress the importance of early recognition of this disorder for prevention and intervention strategies",
"This r and omized , double-blind , placebo-controlled , 6-month trial examined the efficacy and safety of once-daily morning-dosed atomoxetine in adult patients with attention-deficit/hyperactivity disorder ( ADHD ) and the efficacy of atomoxetine in ameliorating symptoms through the evening hours . Patients received once-daily atomoxetine ( n = 250 ) or placebo ( n = 251 ) in the morning for approximately 6 months . The efficacy measures included the Adult ADHD Investigator Symptom Rating Scale ( AISRS ) , Conners ' Adult ADHD Rating Scale-Investigator Rated : Screening Version , Clinical Global Impressions-ADHD-Severity of Illness , and Adult ADHD Quality of Life Scale . Overall , 94 patients r and omized to atomoxetine and 112 patients r and omized to placebo completed the study . On the AISRS total score , Conners ' Adult ADHD Rating Scale-Investigator Rated : Screening Version evening index total score , Clinical Global Impressions-ADHD-Severity of Illness score , and Adult ADHD Quality of Life Scale total score , atomoxetine was statistically superior to placebo at the 10-week and 6-month time points . From the visitwise analysis , the mean ( SD ) AISRS total scores for atomoxetine decreased from 38.2 ( 7.5 ) at baseline to 21.4 ( 12.3 ) at the 6-month end point compared with 38.6 ( 7.0 ) to 25.8 ( 13.2 ) for placebo ( P = 0.035 ) . Nausea , dry mouth , fatigue , decreased appetite , urinary hesitation , and erectile dysfunction were the treatment-emergent adverse events reported significantly more often with atomoxetine . Discontinuations due to adverse events were 17.2 % and 5.6 % for atomoxetine and placebo , respectively ( P atomoxetine is efficacious for treating ADHD in adults when measured 10 weeks and 6 months after initiating treatment . Atomoxetine demonstrated significant efficacy that continued into the evening . Adverse events were similar to previous trials",
"BACKGROUND Despite growing interest in adult attention-deficit/hyperactivity disorder ( ADHD ) , little is known about predictors of persistence of childhood cases into adulthood . METHODS A retrospective assessment of childhood ADHD , childhood risk factors , and a screen for adult ADHD were included in a sample of 3197 18 - 44 year old respondents in the National Comorbidity Survey Replication ( NCS-R ) . Blinded adult ADHD clinical re appraisal interviews were administered to a sub- sample of respondents . Multiple imputation ( MI ) was used to estimate adult persistence of childhood ADHD . Logistic regression was used to study retrospectively reported childhood predictors of persistence . Potential predictors included socio-demographics , childhood ADHD severity , childhood adversity , traumatic life experiences , and comorbid DSM-IV child-adolescent disorders ( anxiety , mood , impulse-control , and substance disorders ) . RESULTS Blinded clinical interviews classified 36.3 % of respondents with retrospectively assessed childhood ADHD as meeting DSM-IV criteria for current ADHD . Childhood ADHD severity and childhood treatment significantly predicted persistence . Controlling for severity and excluding treatment , none of the other variables significantly predicted persistence even though they were significantly associated with childhood ADHD . CONCLUSIONS No modifiable risk factors were found for adult persistence of ADHD . Further research , ideally based on prospect i ve general population sample s , is needed to search for modifiable determinants of adult persistence of ADHD",
"Objective : This study evaluates dexmethylpheni date extended release ( d-MPH-ER ) in adults with ADHD . Method : Following a 5-week , r and omized , controlled , fixed-dose study of d-MPH-ER 20 to 40 mg/d , 170 adults entered a 6-month open-label extension ( OLE ) to assess long-term safety , with flexible dosing of 20 to 40 mg/d . Exploratory effectiveness outcomes included change from Week 5 on ADHD Rating Scale ( ADHD-RS ) and proportion of responders on Clinical Global Impressions — Improvement ( CGI-I ) scale . Results : 103 patients completed OLE , and effectiveness was evaluable in 102 patients . d-MPH-ER was well tolerated ; the most common adverse events ( > 15 % ) were headache , insomnia , and decreased appetite . Mean improvements in ADHD-RS score were −10.2 for patients switched from placebo to d-MPH-ER ( n = 20 ) and −8.4 for those maintained on d-MPH-ER ( n = 82 ) . Respective CGI-I responder rates were 95.0 % and 95.1 % . Conclusion : Once-daily d-MPH-ER 20 to 40 mg is safe and effective for long-term treatment of adult ADHD . ( J. of Att . Dis . 2009 ; 12(5 ) 449 - 459",
"The height of young adults who were treated with methylpheni date hydrochloride in childhood because of hyperactivity ( average daily dose , 45 mg ; duration of treatment , six months to five years ) was studied . There was no significant difference in height between the treated patients ( n = 61 ) and controls ( n = 99 ) ; both groups were at the national US norm in stature . The findings indicated that methylpheni date therapy does not compromise final height , even when it has an adverse impact on children 's growth rate during the active treatment phase . A compensatory growth rate , or growth rebound , appears to occur following discontinuation of stimulant therapy",
"Objectives : Atomoxetine ( ATX ) once daily was compared with placebo ( PBO ) in adults with attention-deficit/hyperactivity disorder ( ADHD ) at 12 and 24 weeks . Methods : Patients were r and omized to PBO ( n = 234 ) or ATX ( 60 - 100 mg ; n = 268 ) for 24 weeks following a 2-week on-label ( 40 mg for 3 days then 80 mg ) or slow ( 40 mg for 7 days then 80 mg ) titration . After 24 weeks , PBO patients were rer and omized to either ATX titration strategy . Efficacy measures included the Conners ' Adult ADHD Rating Scale Total ADHD Symptoms score , Clinical Global Impression-ADHD-Severity , Montgomery-Asberg Depression Rating Scale , and State-Trait Anxiety Inventory . General and titration safety measures and tolerability were evaluated . Results : Conners ' Adult ADHD Rating Scale Total ADHD Symptoms score reduction was greater with ATX over PBO at 12 weeks ( −14.33 vs −10.05 ; P on Conners ' Adult ADHD Rating Scale Total ADHD Symptoms ) was greater for ATX ( 68 % ) than PBO ( 42 % ; P weeks . Clinical Global Impression-ADHD-Severity improvement was greater for ATX over PBO at 8 and 24 weeks ( P changes in depressive or anxiety measures for either group . Discontinuation due to an adverse event was greater for on-label versus slow titration , although the rate of patients experiencing adverse events were comparable . Common adverse events included dry mouth , nausea , and decreased appetite . Conclusions : Atomoxetine demonstrated significant improvement in ADHD symptoms at 12 and 24 weeks over PBO . Adverse events overall and for on-label or slow titration to ATX were similar and consistent with previous adult ATX studies",
"We conducted a 3-phase , double-blind , placebo-controlled , parallel study design of osmotic-release oral system (OROS)-methylpheni date ( MPH ) in adults ( 19 - 60 years of age ) with attention deficit/hyperactivity disorder as classified by the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition . Phase 1 of the study was a 6-week , acute efficacy trial ( n = 223 ) , phase 2 was a 24-week , double-blind continuation study of responders ( n = 96 ) , and phase 3 was a double-blind , placebo-controlled , 4-week discontinuation study ( n = 23 ) . The mean daily dosage at phase 1 endpoint was 78.4 ± 31.7 mg ( 0.97 ± 0.32 mg/kg ) OROS-MPH and 96.6 ± 26.5 mg ( 1.16 ± 0.19 mg/kg ) placebo ( P 0.0001 ) . Clinical response at phase 1 endpoint was significantly greater in the OROS-MPH group ( 62 % , n = 67 vs 37 % , n = 41 ; P the rate of relapse between OROS-MPH responders r and omized to placebo and those r and omized to continue active treatment ( 18 % , n = 2 vs 0 % , n = 0 ; P = 0.1 ) . As expected , decreased appetite , insomnia , being tense/jittery , mucosal dryness , and neurological symptoms were statistically significantly associated with OROS-MPH treatment . More work is needed to be conducted with larger sample s being followed to study completion to better underst and the long-lasting impact of pharmacotherapy for adult attention-deficit/hyperactivity disorder",
"We develop a mathematical model to account for the complex relationship between drug dose and clinical response in psychopharmacologic research . The model specifies relationships among drug dose , drug bioavailability , pharmacokinetic factors , course moderators , clinical response and the heterogeneity of the disorder , and allows for the derivation of results that have implication s for experimental design in psychopharmacologic research . These results form the basis for computer simulations which indicate that r and om assignment to two fixed doses is more powerful and less sensitive to heterogeneity than assignment to clinical ly determined doses . Fixed dose design s , however , tend to overestimate the magnitude of drug bioavailability- clinical response relationships . Clinical ly determined dose design s are useful in some experimental situations ; their effectiveness is enhanced by systematic ally reducing the clinical ly determined dose . Larger dose reductions improve the ability to detect bioavailability- clinical response relationships",
"A three-year open-label study of atomoxetine in adults with ADHD followed two multicenter , double-blind trials . In the double-blind trials , female gender and higher levels of emotional symptoms were associated with better outcome . Following a 4-week placebo washout period , 384 ( of 536 ) subjects continued into the open-label study . 61 % of subjects entering this open-label study remained after 6 months at an average dose of 100 mg/day . Subjects who had previously responded to double-blind atomoxetine achieved maximum response after 8 weeks of open-label medication , but others continued to improve for 36 weeks . Women improved more ( 7.7 ± 6.4 ) than men ( 6.1 ± 6.4 ) on the Wender – Reimherr Adult Attention Deficit Disorder Scale ( WRAADDS ) ( P = .007 ) and the Conners ’ Adult ADHD Rating Scale ( P = .03 ) . Subjects with emotional dysregulation improved more than others on the WRAADDS ( P = .001 ) . Responders ultimately improved approximately 60 % in attentional , hyperactive/impulsive , and emotional symptoms . Thirty-nine percent of atomoxetine double-blind non-responders became responders during open-label treatment",
"BACKGROUND Attention-deficit/hyperactivity disorder ( ADHD ) is an early-onset neuropsychiatric disorder that affects 3 % to 7 % of school-age children and 4 % of adults . Its pathophysiology is thought to involve the dopaminergic and nor-adrenergic pathways associated with attention control and impulsivity . These symptoms have largely been defined in the childhood population , but the course of the condition and expression in the adult population are not as well characterized . METHOD This is an ongoing , 3-year , open-label study consisting of adults with DSM-IV ADHD who were previously enrolled in 1 of 2 double-blind , acute-treatment studies of atomoxetine . The results of the interim analysis reported here were derived from the study of 384 patients at 31 sites who had been studied for a period of up to 97 weeks . The primary efficacy measure was the Conners ' Adult ADHD Rating Scale-Investigator Rated : Screening Version ( CAARS-Inv : SV ) total ADHD symptom score . In addition , safety , adverse events , and vital sign measurements were assessed . RESULTS Significant improvement was noted with atomoxetine therapy , with mean CAARS-Inv : SV total ADHD symptom scores decreasing 33.2 % from 29.2 ( baseline of open-label therapy ) to 19.5 ( endpoint of open-label therapy ) ( p secondary efficacy measures . Adverse events consisted primarily of pharmacologically ( noradrenergic ) expected effects , such as increases in heart rate and blood pressure and a slight decrease in weight . CONCLUSION The results of this interim analysis of an ongoing , open-label study of adults with ADHD support the long-term efficacy , safety , and tolerability of atomoxetine for the treatment of adult ADHD",
" Prospect i ve young adult outcomes ( mean age 21.8 years ) of children who had been diagnosed as having attention deficit disorder with hyperactivity and who had been treated with methylpheni date for at least 3 years were compared with those of a matched normal control group and a group of hyperactive young adults who had not received any stimulant treatment . Results suggest that in many areas , e.g. , school , work , and personality disorders , stimulant-treated hyperactives function significantly worse than matched normal controls but similar to untreated hyperactives . In some areas , e.g. , less car accidents , more positive view of childhood , later delinquency , and better social skills and self-esteem , stimulant-treated hyperactives did better than their untreated counterparts . Thus stimulant treatment for hyperactive children may not eliminate educational work or life difficulties , but may result in less social ostracism and improved feelings toward themselves and others"
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Introduction Periradicular surgery involves the placement of a root-end filling following root-end resection , to provide an apical seal to the root canal system . Historically several material s have been used in order to achieve this seal . Recently a class of material s known as Bioceramics have been adopted . The aim of this article is to provide a review of the outcomes of periradicular surgery when Bioceramic root-end filling material s are used on human permanent teeth in comparison to " traditional " material s. Methods & results An electronic literature search was performed in the data bases of Web of Science , PubMed and Google Scholar , between 2006 and 2017 , to collect clinical studies where Bioceramic material s were utilised as retro grade filling material s , and to compare such material s with traditional material s. In this search , 1 systematic review and 14 clinical studies were identified . Of these , 8 reported the success rates of retro grade Bioceramics , and 6 compared treatment outcomes of mineral trioxide aggregate ( MTA ) and traditional cements when used as root-end filling material s. Conclusion Bioceramic root-end filling material s are shown to have success rates of 86.4 - 95.6 % ( over 1 - 5 years ) . Bioceramics has significantly higher success rates than amalgam , but they were statistically similar to intermediate restorative material ( IRM ) and Super ethoxybenzoic acid ( Super EBA ) when used as retro grade filling material s in apical surgery . However , it seems that the high success rates were not solely attributable to the type of the root-end filling material s. The surgical/microsurgical techniques and tooth prognostic factors may significantly affect treatment outcome
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"INTRODUCTION Recent meta-analyses of the outcome of apical surgery using modern techniques including microsurgical principles and high-power magnification have yielded higher rates of healing . However , the information is mainly based on 1- to 2-year follow-up data . The present prospect i ve study was design ed to re-examine a large sample of teeth treated with apical surgery after 5 years . METHODS Patients were recalled 5 years after apical surgery , and treated teeth were classified as healed or not healed based on clinical and radiographic examination . ( The latter was performed independently by 3 observers ) . Two different methods of root-end preparation and filling ( primary study parameters ) were to be compared ( mineral trioxide aggregate [ MTA ] vs adhesive resin composite [ COMP ] ) without r and omization . RESULTS A total of 271 patients and teeth from a 1-year follow-up sample of 339 could be re-examined after 5 years ( dropout rate = 20.1 % ) . The overall rate of healed cases was 84.5 % with a significant difference ( P = .0003 ) when comparing MTA ( 92.5 % ) and COMP ( 76.6 % ) . The evaluation of secondary study parameters yielded no significant difference for healing outcome when comparing subcategories ( ie , sex , age , type of tooth treated , post/screw , type of surgery ) . CONCLUSIONS The results from this prospect i ve nonr and omized clinical study with a 5-year follow-up of 271 teeth indicate that MTA exhibited a higher healing rate than COMP in the longitudinal prognosis of root-end sealing",
"Introduction Root-end preparation and restoration with an endodontic material are required when nonsurgical endodontic retreatment has failed or is impossible . The present clinical study reports the treatment outcomes of periradicular surgery using calcium-enriched mixture ( CEM ) cement . Material s and Methods A prospect i ve outcome study of periradicular surgery using CEM was conducted on 14 permanent teeth with persistent apical periodontitis . Using a st and ardized surgical protocol , 2 - 3 mm of the root apex was resected ; approximately 3 mm deep root-end cavities were ultrasonically prepared and filled with CEM cement . All patients were available for recall . Results Clinical and radiographic examination revealed complete healing of periradicular lesions , i.e. regeneration of periodontal ligament and lamina dura in 13 teeth ( 93 % success ) during a mean time of 18 months ; moreover , the teeth were functional and asymptomatic . Conclusion Favorable treatment outcomes in this prospect i ve clinical study suggested that CEM cement may be a suitable root-end filling bio material",
"Introduction : This prospect i ve r and omized controlled study evaluated the clinical and radiographic outcome of endodontic microsurgery when using iRoot BP Plus Root Repair Material ( BP‐RRM ; Innovative BioCeramix Inc , Vancouver , BC , Canada ) or mineral trioxide aggregate ( MTA ) as the retro grade filling material and analyzed the relationship between some potential prognostic factors and the outcome of the surgery . Methods : By using strict inclusion and exclusion criteria , 240 teeth were successfully enrolled and r and omly and equally allocated to either the MTA or BP‐RRM treatment group . A st and ardized surgical procedure was performed by a single operator . The patients were followed up at 1 week , 3 months , 6 months , and 12 months ; follow‐up included clinical and radiographic examination . Clinical and radiographic evaluations acquired at the 12‐month follow‐up were taken as the primary outcome . For the identification of prognostic factors , the dichotomous outcome ( success vs failure ) was taken as the dependent variable . Results : A total of 158 teeth were analyzed at the 12‐month follow‐up , including 87 teeth in the MTA group and 71 teeth in the BP‐RRM group . The success rate in the MTA and BP‐RRM groups was 93.1 % ( 81/87 teeth ) and 94.4 % ( 67/71 teeth ) , respectively ( P > .05 ) . Three significant outcome predictors were identified : quality of root filling ( P tooth type ( P and size of the lesion ( P that BP‐RRM is comparable with MTA in clinical outcome when used as root‐end filling material s in endodontic microsurgery",
"This clinical study prospect ively evaluated the influence of various predictors on healing outcome 1 year after periapical surgery . The study cohort included 194 teeth in an equal number of patients . Three teeth were lost for the follow-up ( 1.5 % drop-out rate ) . Clinical and radiographic measures were used to determine the healing outcome . For statistical analysis , results were dichotomized ( healed versus nonhealed ) . The overall success rate was 83.8 % ( healed cases ) . The only individual predictors to prove significant for the outcome were pain at initial examination ( p=0.030 ) and other clinical signs or symptoms at initial examination ( p=0.042 ) , meaning that such teeth had lower healing rates 1 year after periapical surgery compared with teeth without such signs or symptoms . Logistic regression revealed that pain at initial examination ( odds ratio=2.59 , confidence interval=1.2 - 5.6 , p=0.04 ) was the only predictor reaching significance . Several predictors almost reached statistical significance : lesion size ( p=0.06 ) , retrofilling material ( p=0.06 ) , and postoperative healing course ( p=0.06 )",
"This in vitro study used rhodamine B fluorescent dye and a confocal microscope to evaluate the sealing ability of amalgam , super EBA , and a mineral trioxide aggregate when used as root end filling material s. Thirty single-canal teeth were cleaned , shaped , and obturated with gutta-percha and root canal sealer . After application of nail polish to the external surface , the apical 3 mm of each root was resected and 3-mm deep root end preparations were made . The roots were r and omly divided into three groups and the root end preparations filled with the experimental material s. All roots were then exposed to an aqueous solution of rhodamine B fluorescent dye for 24 h , longitudinally sectioned , and the extent of dye penetration measured using a confocal microscope . Statistical analysis showed that the mineral trioxide aggregate leaked significantly less than amalgam and super EBA",
"INTRODUCTION The purpose of the present study was to evaluate the clinical outcomes of endodontic microsurgery when super ethoxy-benzoic acid ( Super EBA ; Harry J. Bosworth , Skokie , IL ) and mineral trioxide aggregate ( MTA ) were used as root-end filling material s in a prospect i ve r and omized controlled study . METHODS Of the 388 teeth eligible for endodontic microsurgery , 128 teeth were excluded from the study , and 260 teeth were r and omly assigned to either the Super EBA group or the MTA group with equal numbers using the \" minimization method . \" Endodontic microsurgical procedures were performed according to the Yonsei protocol reported in a previous study and were carried out by a single operator . The patients were followed up at 3 , 6 , and 12 months . The primary outcome measure was the change in the apical bone density at 12 months , and the secondary outcome measures were the presence of clinical symptoms or abnormal findings at 12 months . RESULTS A total of 192 teeth were examined at the 12-month follow-up ; 102 teeth were in the Super EBA group , and 90 were in the MTA group . The overall success rate was 94.3 % , with a success rate of 95.6 % ( 86/90 teeth ) for MTA and 93.1 % ( 95/102 teeth ) for Super EBA . The statistical analysis of the success rate results did not show any significant difference between the groups ( P = .472 ) . CONCLUSIONS In this prospect i ve r and omized controlled study , there was no significant difference in the clinical outcomes of endodontic microsurgery when Super EBA and MTA were used as root-end filling material",
"OBJECTIVE The purpose of this study was to evaluate the potential benefit of an ultrasonic device in apical surgery on the outcome of treatment . STUDY DESIGN A r and omized prospect i ve design was used in a st and ardized treatment protocol . Patients were allocated to treatment with an ultrasonic device ( P-Max Newtron ) or treatment with a bur in an otherwise similar protocol . One year after treatment the results were evaluated by 2 oral and maxillofacial surgeons who were blinded for the therapy . RESULTS Out of a total group of 399 patients who were included in the study , adequate follow-up could be obtained in 290 patients . The overall success rate in the ultrasonic group was 80.5 % and in the group treated with a bur 70.9 % ( P = .056 ) . In molars , the difference in success rate was significant ( P = .02 ) . CONCLUSION The use of an ultrasonic device in apical surgery improved the outcome of treatment . In molars this effect was significant",
"Objectives : The aim of this study was to evaluate marginal adaptation of mineral trioxide aggregate ( MTA ) , calcium enriched mixture ( CEM ) cement , Biodentine and BioAggregate in presence of normal saline and human blood . Material s and Methods : In this in-vitro experimental study , 80 extracted single-rooted human teeth were instrumented and filled with gutta-percha . After resecting the root-end , apical cavity preparation was done and the teeth were r and omly divided into 4 groups (N=20)(a total of 8 subgroups ) . Root-end filling material s were placed in 3 mm root-end cavities prepared ultrasonically . Half the specimens in each group were exposed to normal saline and the other half to fresh whole human blood . After 4 days , epoxy resin replicas of the apical portion of sample s were fabricated and scanning electron microscopy ( SEM ) analysis was performed to find gaps in the adaptation of the root-end filling material s at their interface with dentin . The Kruskal-Wallis and Mann-Whitney tests were used for statistical analysis of data with P marginal adaptation of the 8 tested groups ( P>0.05 ) . Conclusion : Based on the results , blood contamination does not affect the marginal adaptation of MTA , CEM cement , Biodentine or BioAggregate",
"AIM To compare healing after root-end resection with a root-end filling of mineral trioxide aggregate ( MTA ) or smoothing of the ortho grade gutta-percha ( GP ) root filling . METHODOLOGY Forty-four patients ( consisting of 52 teeth with periapical infection ) , average age of 54.6 years ( range 30 - 77 ) participated in a r and omized clinical trial ( RCT ) comparing the MTA and GP treatment methods . Radiographs produced 1-week and 12 months post-operatively were compared after blinding for treatment method , and healing was assessed as complete , incomplete , uncertain , or unsatisfactory . RESULTS Six teeth were not available for the 12-month follow-up : three teeth ( GP ) had been re-operated because of pain and two teeth ( one GP , one MTA ) had been extracted because of root fracture ( these five teeth were classified as failures ) . One patient ( GP ) was not available for recall . In the GP group , seven teeth ( 28 % ) showed complete healing , six teeth ( 24 % ) incomplete healing , six teeth ( 24 % ) uncertain healing and two teeth ( 8 % ) unsatisfactory healing after 1 year . In the MTA group , 22 teeth ( 85 % ) showed complete healing , three teeth ( 12 % ) incomplete healing , and none were scored as uncertain or unsatisfactory healing after 1 year . The difference in healing between the GP and the MTA groups was significant ( P MTA had significantly better healing ( 96 % ) than teeth treated by smoothing of the ortho grade GP root filling only ( 52 % )",
"A prospect i ve outcome study of periradicular surgery using microsurgical techniques and root-end filling with mineral trioxide aggregate ( MTA ) was performed . Nonhealing endodontically treated teeth ( n = 321 ) were included in the study . Surgery was completed under local anesthesia using a st and ardized clinical protocol . Patients were recalled periodically and examined for signs and symptoms of failure . Thirty-nine teeth were lost from recall . Of the 276 teeth examined , 163 showed complete healing radiographically with no other signs and symptoms ; 82 teeth had no symptoms but incomplete or uncertain healing , and 31 teeth showed nonhealing ( three had persistent pain despite evidence of complete radiologic healing and eight teeth did not heal for reasons unrelated to the surgical treatment ) . The overall success rate was 88.8 % , including all teeth with no clinical symptoms . In this study , the use of MTA as a root-end filling , following microsurgical techniques , showed a high success rate",
"A prospect i ve study was set up to evaluate a one-visit apicectomy technique . Calcium hydroxide cement was used as the root canal filling material . The calcium hydroxide cement set rapidly and clearly revealed the position , size and outline form of the root canals at the level of resection . This facilitated preparation of the apical cavities to a depth of 3 mm . Each cavity was varnished before placement of the amalgam . Sixty-eight patients ( 93 teeth ) were included in the study . Five patients ( 8 teeth ) were lost to follow-up . The success rate , based on clinical and radiographic examination after a minimum of 2 years , was 91.8 per cent",
"INTRODUCTION The purpose of the present study was to evaluate the long-term clinical outcome of endodontic microsurgery when mineral trioxide aggregate ( MTA ) and super ethoxybenzoic acid ( Super EBA ; Harry J. Bosworth , Skokie , IL ) were used as root-end filling material s. Additionally , this study aim ed to compare the clinical outcome of endodontic microsurgery at the 1-year follow-up with that at the 4-year follow-up . METHODS Two hundred sixty teeth were r and omly assigned to either the MTA or Super EBA group in equal numbers using the minimization method . Endodontic microsurgery was performed according to the Yonsei protocol . The previous study of 192 teeth examined at the 1-year follow-up revealed a success rate of 95.6 % for MTA and 93.1 % for Super EBA . Patients were recalled 4 years after surgery , and treated teeth were classified as successes or failures with Molven 's criteria . The Pearson chi-square test and the McNemar test were conducted to analyze and compare the success rates . RESULTS A total of 182 teeth were examined at the 4-year follow-up . The success rate was 91.6 % for MTA and 89.9 % for Super EBA . Statistical analysis of the success rate did not show any significant difference between the 2 material s ( P = .8 ) . The overall success rate at the 4-year follow-up was 89.5 % , which was slightly lower compared with 94.3 % at the 1-year follow-up . However , there was no significant difference between the follow-up periods ( P = .063 ) . CONCLUSIONS This study identified no significant difference in the 4-year success rates of MTA and Super EBA as root-end filling material s in endodontic microsurgery . Additionally , compared with short-term outcomes , long-term follow-up outcomes were not significantly different",
"An in vitro dye leakage study was performed to compare the sealing ability of high copper amalgam with Copalite , IRM , and EBA cement when used as retrofilling material s. Fifty-one extracted anterior teeth were instrumented and then obturated with gutta-percha . The apical 3 mm of the roots were resected and 2-mm deep apical preparations were made . The roots were then r and omly placed into three groups and retrofilled with one of the experimental material s. After 72 h in India ink , the teeth were cleared and evaluated for leakage with a stereomicroscope . No leakage was evident in the three teeth used as negative controls and complete leakage was noted in the three positive control teeth . Statistical analysis showed that IRM and EBA cement had significantly less leakage than amalgam with Copalite . The difference between the EBA cement and IRM was not significant",
"INTRODUCTION The aim of this in vivo study was to compare the response of periradicular tissues to mineral trioxide aggregate ( MTA ) and calcium-enriched mixture ( CEM ) cement as root-end fillings and to analyze hard tissue healing after periradicular surgery . METHODS Intentional periradicular lesions were induced in 32 premolar teeth in 4 beagle dogs . The root canals were prepared , dried , and obturated with laterally condensed gutta-percha with sealer , and the coronal access cavities were filled with amalgam . After surgical exposure of the apices , 2 - 3 mm of the apical root was resected , and root-end cavities were ultrasonically prepared . The root-end cavities were r and omly filled with MTA or CEM cement . After 2 months , the animals were killed ; tissue blocks were removed and prepared for histologic examination . Hard tissue healing including cementum and new bone formation in addition to concentration and extent of inflammation were evaluated . RESULTS Eight sample s were excluded . The major finding was the cementum deposition adjacent to MTA in 11 of 12 sample s and CEM cement in 10 of 12 sample s. With one-way analysis of variance , no significant difference was observed between the periradicular tissue response to tested material s. CONCLUSIONS CEM cement and MTA were associated with regenerative periapical tissue response when used as root-end filling bio material",
"Introduction : The aim of this study was to investigate the outcome of endodontic microsurgery and analyze the prognostic factors . Methods : Our prospect i ve cohort study included 98 teeth in 81 patients . An endodontist performed all surgical procedures using endodontic microsurgical approaches . The treated teeth were recalled and examined clinical ly and radiographically at least 1 year after surgical treatment . The outcome was determined based on clinical and radiographic results . Radiographic healing was classified into 4 categories : complete , incomplete , uncertain , and unsatisfactory healing . An analysis of predictors was performed using multivariate logistic regression . Results : At recall , 74 of the 98 teeth ( 75.5 % ) were examined 12 to 30 months after surgery ; 71 of the 74 teeth were analyzed clinical ly and radiographically , and 3 teeth had been extracted . On periapical radiographs , 55 ( 74.3 % ) of the 74 teeth showed complete healing , whereas 12 ( 16.2 % ) demonstrated incomplete healing . Together the percentage of complete and incomplete healing was 90.5 % ( 67/74 ) , and all 67 teeth were clinical ly normal . Uncertain healing was observed in 3 teeth ( 4.1 % ) , one of which was symptomatic with swelling and sinus tract involvement and the other 2 were asymptomatic . The remaining 1 tooth ( 1.4 % ) showed unsatisfactory healing and was asymptomatic . The use as an abutment was found to be a negative factor associated with patient outcome ( P complete and incomplete healing of teeth 12 to 30 months after endodontic microsurgery was 90.5 % . The use as an abutment may have a negative effect on treatment outcome",
"INTRODUCTION The aim of apical surgery is to hermetically seal the root canal system after root-end resection , thereby enabling periradicular healing . The objective of this nonr and omized prospect i ve clinical study was to report results of 2 different root-end preparation and filling methods , ie , mineral trioxide aggregate ( MTA ) and an adhesive resin composite ( Retroplast ) . METHODS The study included 353 consecutive cases with endodontic lesions limited to the periapical area . Root-end cavities were prepared with sonic microtips and filled with MTA ( n = 178 ) , or alternatively , a shallow concavity was prepared in the cut root face , with subsequent placement of an adhesive resin composite ( Retroplast ) ( n = 175 ) . Patients were recalled after 1 year . Cases were defined as healed when no clinical signs or symptoms were present and radiographs demonstrated complete or incomplete ( scar tissue ) healing of previous radiolucencies . RESULTS The overall rate of healed cases was 85.5 % . MTA-treated teeth demonstrated a significantly ( P = .003 ) higher rate of healed cases ( 91.3 % ) compared with Retroplast-treated teeth ( 79.5 % ) . Within the MTA group , 89.5%-100 % of cases were classified as healed , depending on the type of treated tooth . In contrast , more variable rates ranging from 66.7%-100 % were found in the Retroplast group . In particular , m and ibular premolars and molars demonstrated considerably lower rates of healed cases when treated with Retroplast . CONCLUSIONS MTA can be recommended for root-end filling in apical surgery , irrespective of the type of treated tooth . Retroplast should be used with caution for root-end sealing in apical surgery of m and ibular premolars and molars"
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Background . Reliable bonding between resin composite cements and high strength ceramics is difficult to achieve because of their chemical inertness and lack of silica content that makes etching impossible . The purpose of this review is to classify and analyze the existing methods and material s suggested to improve the adhesion of zirconia to dental substrate by using composite resins , in order to explore current trends in surface conditioning methods with predictable results . Methods . The current literature , examining the bond strength of zirconia ceramics , and including in vitro studies , clinical studies , and a systematic review , was analyzed . The research in the literature was carried out using PubMed and Cochrane Library data bases , only papers in English , published online from 2013 to 2018 . The following keywords and their combinations were used : Zirconia , 3Y-TZP , Adhesion , Adhesive cementation , Bonding , Resin , Composite resin , Composite material , Dentin , Enamel . Results . Research , in PubMed and Cochrane Library data bases , provided 390 titles with abstract s. From these , a total of 93 publications were chosen for analysis . After a full text evaluation , seven articles were discarded . Therefore , the final sample was 86 , including in vitro , clinical studies , and one systematic review . Various adhesive techniques with different testing methods were examined . Conclusions . Airborne-particle abrasion and tribo-chemical silica coating are the pre-treatment methods with more evidence in the literature . Increased adhesion could be expected after physico-chemical conditioning of zirconia . Surface contamination has a negative effect on adhesion . There is no evidence to support a universal adhesion protocol
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"OBJECTIVES To evaluate the effects of various chemical surface modifications on adhesion between zirconia and resin adhesive . MATERIAL AND METHODS Pre-sintered zirconia discs were sectioned from commercial cylindrical blocks and polished with abrasive papers under running tap water . All the discs were r and omly divided into five study groups according to the methods of surface treatment , including : the control group ( fully sintered , without any modification ) , group S ( fully sintered and s and blasted with silica coated alumina particles ) , group HN ( fully sintered and etched with a blend of mineral acid solution at 100 ° C for 25 min ) , group HF ( fully sintered and etched with 48 % hydrofluoric acid solution at 100 ° C for 25 min ) , and group Si ( coated with silica particles and then fully sintered ) . The mean value of surface roughness was evaluated before further treatment . Resin stubs ( 3.6 mm in diameter and 3 mm in height ) were adhered and light cured on each zirconia disc after the application of a silane coupling agent . In each group , all the sample s were further divided into three subgroups with each n=12 , one for the measurement of initial adhesion strength ( shear bond ) value and the other two were tested after thermal cycling for 10,000 and 20,000 cycles , respectively . The results were analyzed with two-way ANOVA and Turkey HSD ( p of zirconia surface crystallinity . The morphological appearance of zirconia surface after surface treatment was observed with SEM . RESULTS The control group showed the lowest initial shear bond strength ( SBS ) value ( 16.8 ± 2.4 MPa ) and did not survive the aging treatments . All the investigated surface treatments improved resin zirconia bond strength significantly , the group S displaying the highest initial value of 25.1 ± 2.7 MPa . However , the highest resistance to the aging effects of thermal cycling was found in group Si . It was further shown in the XRD examination that only the grit-blasting caused the crystalline transformation from tetragonal phase to monoclinic phase ( T → M ) . On the other h and , such a phase transformation could not be detected in all the other four groups . SIGNIFICANCE Resin zirconia adhesion could be effectively improved by both HF etching and silica coating on zirconia surface , without leading to a T → M crystalline phase transformation",
"This study evaluated the effect of different air-particle abrasion protocol s on the biaxial flexural strength and structural stability of zirconia ceramics . Zirconia ceramic specimens ( ISO 6872 ) ( Lava , 3 M ESPE ) were obtained ( N=336 ) . The specimens ( N=118 , n=20 per group ) were r and omly assigned to one of the air-abrasion protocol s : Gr1 : Control ( as-sintered ) ; Gr2 : 50 µm Al2O3 ( 2.5 bar ) ; Gr3 : 50 µm Al2O3 ( 3.5 bar ) ; Gr4 : 110 µm Al2O3(2.5 bar ) ; Gr5 : 110 µm Al2O3 ( 3.5 bar ) ; Gr6 : 30 µm SiO2 ( 2.5 bar ) ( CoJet ) ; Gr7 : 30 µm SiO2(3.5 bar ) ; Gr8 : 110 µm SiO2 ( 2.5 bar ) ( Rocatec Plus ) ; and Gr9 : 110 µm SiO2 ( 3.5 bar ) ( duration : 20 s , distance : 10 mm ) . While half of the specimens were tested immediately , the other half was subjected to cyclic loading in water ( 100,000 cycles ; 50 N , 4 Hz , 37 ° ° C ) prior to biaxial flexural strength test ( ISO 6872 ) . Phase transformation ( t→m ) , relative amount of transformed monoclinic zirconia ( FM ) , transformed zone depth ( TZD ) and surface roughness were measured . Particle type ( p=0.2746 ) , pressure ( p=0.5084 ) and cyclic loading ( p=0.1610 ) did not influence the flexural strength . Except for the air-abraded group with 110 µm Al2O3 at 3.5 bar , all air-abrasion protocol s increased the biaxial flexural strength ( MPa ) ( Controlnon-aged : 1,030 ± 153 , Controlaged : 1,138 ± 138 ; Experimentalnon-aged : 1,307 ± 184 - 1,554 ± 124 ; Experimentalaged : 1,308 ± 118 - 1,451 ± 135 ) in both non-aged and aged conditions , respectively . Surface roughness ( Ra ) was the highest with 110 µm Al2O3(0.84 µm . FM values ranged from 0 % to 27.21 % , higher value for the Rocatec Plus ( 110 µm SiO2 ) and 110 µm Al2O3 groups at 3.5 bar pressure . TZD ranged between 0 and 1.43 µm , with the highest values for Rocatec Plus and 110 µm Al2O3 groups at 3.5 bar pressure",
"PURPOSE Resin bonding of In-Ceram Zirconia ( ICZ ) ceramics is still a challenge , especially for minimally invasive applications . This study evaluated the adhesion of ICZ to enamel and dentin after different surface treatments of the ceramic . MATERIAL S AND METHODS ICZ ceramic specimens ( diameter : 6 mm ; thickness : 2 mm ) ( N = 100 ) were fabricated following the manufacturer 's instructions and r and omly assigned to 5 groups ( n = 20 ) , according to the surface treatment methods applied . The groups were as follows : group C : no treatment ; group SB : s and blasting ; group SCS-S : CoJet+silane ; group SCS-P : CoJet+Alloy Primer ; group GE-S : glaze+ hydrofluoric acid etching ( 9.6 % ) for 60 s+silane . Each group was r and omly divided into two subgroups to be bonded to either enamel or dentin ( n = 10 per group ) using MDP-based resin cement ( Panavia F2.0 ) . All the specimens were subjected to thermocycling ( 5000x , 5 ° C-55 ° C ) . The specimens were mounted in a universal testing machine and tensile force was applied to the ceramic/cement interface until failure occurred ( 1 mm/min ) . After evaluating all the debonded specimens under SEM , the failure types were defined as either \" adhesive \" with no cement left on the ceramic surface ( score 0 ) or \" mixed \" with less than 1/2 of the cement left adhered to the surface with no cohesive failure of the substrate ( score 1 ) . The data were statistically evaluated using 2-way ANOVA and Tukey 's tests ( α = 0.05 ) . RESULTS The highest tensile bond strength for the enamel surfaces was obtained in group GE-S ( 18.1 ± 2 MPa ) and the lowest in group SB ( 7.1 ± 1.4 MPa ) . Regarding dentin , group CSC-P showed the highest ( 12 ± 1.3 MPa ) and SB the lowest tensile bond strength ( 5.7 ± 0.4 MPa ) . Groups SB , CSC-S , CSC-P , and GE-S did not show significant differences between the different surface treatments on either enamel or dentin surfaces ( p similar bond strength for both the enamel and dentin substrates ( p adhesive failures from ICZ ( score 0 ) were found , on dentin exclusively mixed failures were observed ( score 1 ) . CONCLUSION Adhesion of ICZ to both enamel and dentin can be improved when ceramics are glazed , etched , and silanized , or s and blasted , primed , and cemented with an MDP-based cement",
"This study evaluated the effects of different adhesive strategies on the adhesion of zirconia to dentin using conventional and self-adhesive cements and their corresponding adhesive resins . The occlusal parts of human molars ( N=80 ) were sectioned , exposing the dentin . The teeth and zirconia cylinders ( N=80 ) ( diameter=3.4 mm ; height=4 mm ) were r and omly divided into eight groups according to the factors \" surface conditioning \" and \" cement type \" ( n=10 per group ) . One conventional cement ( CC : RelyX ARC , 3 M ESPE ) and one self-adhesive cement ( SA : RelyX U200 , 3 M ESPE ) and their corresponding adhesive resin ( for CC , Adper Single Bond Plus ; for SA , Scotchbond Universal Adhesive-SU ) were applied on dentin . Zirconia specimens were conditioned either using chairside ( CJ : CoJet , 30 μm , 2.5 bar , four seconds ) , laboratory silica coating ( RC : Rocatec , 110 μm , 2.5 bar , four seconds ) , or universal primer ( Single Bond Universal-UP ) . Nonconditioned groups for both cements acted as the control ( C ) . Specimens were stored in water ( 37 ° C , 30 days ) and subjected to shear bond strength ( SBS ) testing ( 1 mm/min ) . Data ( MPa ) were analyzed using two-way analysis of variance and a Tukey test ( α=0.05 ) . While surface conditioning significantly affected the SBS values ( p=0.0001 ) ( C adhesive . Air-abrasion and the use of the universal primer improved the bond strength of zirconia to dentin compared to the control group , regardless of the type of resin cement used",
"This study aim ed to evaluate the effect of different primer/resin luting agent combinations and alumina air abrasion on the adhesion to zirconia . Eighty blocks ( 4 × 4 × 3 mm ) of Lava Frame Zirconia ( 3 M ESPE ) were produced and r and omly assigned into eight groups ( n=10 ) according to two zirconia surface treatments ( untreated or air abrasion with 50-μm alumina particles ) and four luting systems ( SU : Scotchbond Universal/RelyX Unicem 2 ; ZP : Z-Prime Plus/Duo-link Universal ; MB : Monobond Plus/Variolink II ; and AP : Alloy Primer/ED Primer II/Panavia F 2.0 ) . After the conditioning and primer applications , resin luting agents were manipulated and applied on the zirconia , using a matrix , to form a cylinder ( 2 mm in diameter × 2 mm high ) , followed by photoactivation for 40 seconds . After that , the specimens were stored in distilled water ( 37 ° C ) for 120 days and then su bmi tted to shear bond strength testing , followed by failure mode evaluation under an optical microscope ( 30 × ) . A two-way analysis of variance and Tukey test ( α=0.05 ) were used for data analysis . Alumina air abrasion ( Al ) promoted higher bond values for the three luting systems , except for SU , which showed the best results without air abrasion , while with air abrasion , Al-SU , Al-ZP , and Al-MB presented higher values compared to Al-AP . We concluded that the alumina air abrasion of zirconia surfaces seemed to be dispensable for the SU group , while air abrasion ( topographical alterations ) enhanced the adhesion of the ZP , MB , and AP groups",
"This study compares the bond strength of resin cement and yttrium-stabilized tetragonal zirconia polycrystalline ( Y-TZP ) ceramic with different surface conditioning methods . Two hundred presintered Y-TZP ceramic specimens were prepared , sintered ( 4 × 4 × 4 mm ) , and r and omly assigned to four equal groups as control ( C , no conditioning ) ; airborne particle abraded ( APA , air abrasion with 11 μm Al2O3 ) ; tribochemical silica coating/silane coupling system ( TSC , Rocatec , air abrasion with 110 μm Al2O3 , 30 μm silica-coated Al2O3 and silane ) ; and laser ( L , Er : YAG laser irradiation treated at a power setting of 200 mJ ) . After specimen preparation , composite resin cylinders were prepared and cemented with resin cements ( Clearfil Esthetic , Panavia F 2.0 , Rely X-U100 , Super Bond C&B , and Multilink Automix ) on the ceramic surfaces and kept in an incubator at 37 ° C for 60 days . All specimens were tested for shear bond strength with a universal testing machine , and fractured surfaces were evaluated by environmental scanning electron microscopy . Statistical analysis was performed using Kruskal-Wallis and Mann-Whitney U-tests ( α=0.05 ) . The bond strengths for C and L groups were not significantly different according to adhesive resin cement . APA and TSC result ed in increased bond strength for Panavia F 2.0 and Rely X-U100 resin cements . Additionally , TSC presented higher bond strength with Multilink Automix . Adhesive fracture between the ceramic and resin cement was the most common failure . Complete cohesive fracture at the ceramic or composite cylinders was not observed . Regardless of the adhesive resin cement used , laser treatment did not improve resin bond strength ",
"The purpose of this study is to evaluate the thermocycling effect on the microshear bond strength ( μSBS ) of different self-adhesive resin cements to zirconia using tribochemical silica coating Rocatec ™ ( ROC ) and Er : YAG as surface conditioners . Two hundred forty square-like zirconia sample s were polished and r and omly assigned in four groups according surface treatment applied as follows : ( 1 ) no treatment ( NT ) , ( 2 ) silica coating with ROC , 3 ) Er : YAG laser irradiation ( LAS : 2.940 nm , 200 mJ ; 10 Hz ) , and ( 4 ) laser followed by Rocatec ™ ( LAROC ) . Each group was divided into two subgroups according the resin tested as follows : ( A ) BiFix SE ( BIF ) and ( B ) Clearfil SA ( CLE ) . After 24 h , half of the specimens from each subgroup were tested . The other half was stored and thermocycled ( 5–55 ° C/5,000 cycles ) . A μSBS test was performed using a universal testing machine ( cross head speed = 0.5 mm/min ) . Failure modes were recorded and observed by scanning electronic microscopy . Data was analyzed with ANOVA , Student ’s t test , and chi-square tests , and linear regression was performed ( p higher μSBS results with ROC and LAROC . After aging , ( 1 ) all BIF specimens evidence d severely decreased adhesion with mostly adhesive failures and ( 2 ) CLE maintained the initial results in ROC and LAROC groups , performing better with ROC . Thermocycling did not negatively influence the resin – zirconia μSBS results in the self-adhesive resin cement containing 10-MDP when used on zirconia surface coated with silica , independently of previous Er : YAG surface treatment",
"PURPOSE Resinous cements are widely used for luting zirconia restorations . Adhesive failures have occurred at the cement/zirconia interface , rather than at the cement/dentin interface , suggesting that the cement/zirconia bond may lack durability ; however , few comprehensive , comparative evaluations of fatigue effects have been reported . The rate of fatigue-induced loss of bond strength may be a more important predictor of long-term success than a single snapshot of bond strength after an arbitrary number of thermocycles . Previous studies have failed to identify trends by investigating bond strengths at several different numbers of cycles . This may result in invalid conclusions about which cements have superior bond strengths . The purpose of this study was to investigate the effects of artificial aging by thermocycling and resinous cement type on bond strengths to zirconia . MATERIAL S AND METHODS The effect of the number of thermocycles ( 0 , 1 , 10 , 100 , 1000 , and 10,000 ) on the bond strengths of five resinous cements , two of which were used with and without a primer , and an oxygen-inhibiting gel , was studied . Specimens were r and omly assigned to thermocycle number/cement-type test groups . Because zirconia has a very low thermal diffusivity , exceptionally long thermocycle dwell times were used . Cylinders of zirconia were bonded end-to-end . One end of each bonded specimen was insulated , specimens were thermocycled and tested in shear , and bond strengths were calculated and analyzed . RESULTS Two-way ANOVA revealed that the effects of cement type , the number of thermocycles , and their interaction all significantly affected bond strength ( p bond strengths , and two cements effectively recorded zero bond strengths . Failure modes were cement specific , but adhesive modes predominated . Fatigue resistance of two cements was greatly improved by use of a primer and an oxygen-inhibiting gel , as recommended by their respective manufacturers . CONCLUSIONS Both the type of resin cement and the number of thermocycles influenced bond strength . Fatigue through thermocycling affected different cement types in different ways . Some material s displayed more rapid loss of bond strength than others . Cements differed in their failure modes",
"PURPOSE To compare the effect of silica (Si)-based nano-coating deposited by reactive magnetron sputtering ( RMP ) with that of conventional surface conditioning using metal/zirconia primer alone or after air-particle abrasion on the adhesion of resin cements to zirconia ceramic . MATERIAL S AND METHODS Two hundred forty zirconia ceramic blocks ( Cercon ) were sintered , finished with 1200- grit SiC paper under water cooling , and cleaned ultrasonically in distilled water for 10 min . The blocks ( 4.5 mm x 3.5 mm x 4.5 mm ) were r and omly divided into 24 groups ( n = 10 ) according to 3 testing parameters : a ) resin cements ( Multilink , Panavia F , RelyX U100 ) , b ) surface conditioning ( no conditioning as control group ; Metal/Zirconia Primer ; air abrasion + Metal/Zirconia Primer ; Si-based nanofilm + Monobond s ) ; c ) aging ( no aging vs thermocycling at 5 ° C to 55 ° C , 6000 cycles ) . The nanofilm was deposited by direct current using argon/oxygen plasma ( 8:1 in flux ) on the zirconia surface . Resin cements were bonded to zirconia surfaces using polyethylene molds . The shear bond strength ( SBS ) test was performed using a universal testing machine ( 1 mm/min ) , and after debonding , the substrate and adherent surfaces were analyzed using optical and scanning electron microscopes to categorize the failure types . The data were statistically evaluated using 3-way ANOVA and Tukey 's test ( 5 % ) . RESULTS Resin cement type ( p surface conditioning method ( p aging condition ( p the bond strength results . Interactions were also significant ( p highest SBS ( 21.8 ± 6.7 MPa ) . After aging , the SBS results decreased in the air-abraded groups for all cements ( 4.54 to 9.44 MPa ) and showed no statistical significance compared to the Si-based nanocoated groups ( 4.24 to 6.44 MPa ) . After air-abrasion and primer application , only Panavia F and RelyX U100 cements showed exclusively mixed failures , but after nanofilm coating and silanization , all cements showed exclusively mixed failures with and without aging . CONCLUSION Chemical adhesion of the resin cements tested to zirconia was similar after silica-based nanofilm deposition and air abrasion followed by primer application",
"PURPOSE To evaluate the effect of different bonding strategies on short- and long-term bis-GMA-based resin cement bond strengths to zirconia . MATERIAL S AND METHODS One hundred twenty sample s of fully-sintered zirconia ( Prettau Zirconia ) were s and blasted and r and omly distributed into 5 groups ( n = 24 ) : UA : Scotchbond Universal Adhesive ; SZP : Signum Zirconia Bond I + II ; ZPP : Z-Prime Plus ; EXP : MZ experimental primer ; CO : no primer application ( control ) . After performing these surface treatments , translucent tubes ( 0.8 mm diameter and 1.0 mm height ) were placed on the zirconia specimens , and bis-GMA-based cement ( Duo-Link ) was injected into them and light cured . Specimens were tested for microshear bond strength either 24 h or 6 months ( m ) after water storage ( 37 ° C ) and surfaces were characterized by SEM and EDX . Two-way ANOVA and Tukey 's post-hoc test ( p The mean bond strengths ( MPa ± SD ) were : UA=14.6 ± 4.7a ( 24 h ) ; 16.0 ± 4.8a ( 6 m ) ; SZP = 14.0 ± 5.4ab ( 24 h ) ; 11.9 ± 2.6ab ( 6 m ) ; ZPP=8.0 ± 1.8b ( 24 h ) ; 8.6 ± 3.3b ( 6 m ) ; EXP = 1.2 ± 0.5c ( 24 h ) ; 0.6 ± 0.7c ( 6 m ) ; CO=1.0 ± 1.2c ( 24 h ) ; 1.3 ± 1.2c ( 6 m ) . Bonding strategy significantly influenced bond strength ( p = 0.0001 ) , but storage time did not ( p = 0.841 ) . Groups UA and SZP showed a homogeneous layer covering the zirconia surface . In these groups , EDX demonstrated the presence of phosphorus . Group ZPP result ed in a nonhomogeneous layer , exposing the zirconia substrate underneath . EXP application result ed in an undetectable layer . CONCLUSION Water storage did not affect resin cement bond strengths to zirconia irrespective of the surface treatment . Bis-GMA-based resin cement bond strengths to zirconia are affected by specific bonding strategies",
"OBJECTIVES This study evaluated the adhesion of self-adhesive resin cement to zirconia after various surface conditioning methods in non-aged and aged conditions . METHODS Zirconia ( IPS e.max ZirCAD , Ivoclar Vivadent ) and resin composite blocks were obtained and r and omly divided into four groups according to one of the following surface conditioning methods : C : No surface treatment ( Control ) ; AS : Air abrasion ( 50 µm Al2O3 ) at low pressure ( 0.2 MPa ) plus silane ( Monobond Plus , Ivoclar Vivadent ) ; MC : Methylene chloride for 60 min ; CE : Chemical etching solution at 100 ° C for 60 min . Surface roughness ( Ra ) measurements were performed on the control and conditioned zirconia specimens using a profilometer . Each conditioned zirconia block was bonded to its corresponding resin composite block using self-adhesive resin cement ( RelyX Unicem Aplicap , 3 M ESPE ) under a load of 300 g. Half of the groups were tested without aging ; the other half were tested after x6000 thermocycling . Sticks were obtained from bonded specimens and subjected to microtensile bond strength ( MTBS ) testing in a universal testing machine ( 0.5 mm/min ) . Failure types were classified after debonding . Data ( MPa ) were analyzed using two-way ANOVA and Tukey 's tests ( α = 0.05 ) . RESULTS The highest mean Ra value was obtained in Group CE ( 0.52 µm ) , and the lowest in Group C ( 0.25 µm ) . Significantly lower MTBS test results were obtained in Group C , both in non-aged ( 17.4 ± 1.1 MPa ) and aged ( 5.11 ± 0.5 MPa ) conditions than in the other groups ( 34.6 ± 1.5 to 51.2 ± 1.1 MPa ; 28.0 ± 0.9 to 49.5 ± 1.0 MPa in non-aged and aged conditions , respectively ) ( P highest MTBS test results in both non-aged and aged conditions ( 51.2 ± 1.1 MPa and 49.5 ± 1 MPa , respectively ) ( P 0.05 ) . Failure types were predominantly adhesive in all groups before and after aging . After aging , less adhesive and more mixed and cohesive failures in cement were observed in Groups AS and CE than in the other groups . CONCLUSION Chemical etching of zirconia may have potential use as a substitute for air abrasion as a surface conditioning method for zirconia",
"This study evaluated the effects of single-bottle , multi purpose , universal adhesives on the bond strength of resin cement to zirconia ceramic . Polished zirconia ceramic ( Cercon base ) discs were r and omly divided into four groups ( n=40 ) according to the applied surface-conditioning agent : Single Bond 2 , Single Bond Universal , All-Bond Universal , and Alloy Primer . Cured composite cylinders ( Ø 0.8 mm × 1 mm ) were cemented to the conditioned zirconia specimens with resin cement ( RelyX ARC ) . The bonded specimens were subjected to a microshear bond-strength test after 24 hours of water storage and after 10,000 cycles of thermocycling . The surface-conditioning agent significantly influenced the bond strength ( p highest initial bond strength ( 37.7 ± 5.1 MPa ) , followed by All-Bond Universal ( 31.3 ± 5.6 MPa ) , Alloy Primer ( 26.9 ± 5.1 MPa ) , and Single Bond 2 ( 8.5 ± 4.6 MPa ) . Artificial aging significantly reduced the bond strengths of all the test groups ( p the highest bond-strength value ( 26.9 ± 6.4 MPa ) . Regardless of artificial aging , Single Bond Universal and All-Bond Universal showed significantly higher bond strengths than Alloy Primer , a conventional metal primer",
"PURPOSE To determine whether universal primers alone can deliver similar levels of adhesion of resin cement to zirconia ceramic when compared to their application in conjunction with airborne-particle abrasion . MATERIAL S AND METHODS Sintered zirconia blocks ( N = 160 ) ( Lava , 3 M ESPE ) , ( 5.25 × 5.25 × 3 mm3 ) were embedded in acrylic resin , polished , and r and omly distributed into 16 groups ( n = 10 per group ) , according to the factors \" universal primer \" ( 8 levels ) and \" air-particle abrasion \" ( 2 levels ) : 1 . ctr : control , without application of a universal primer ; 2 . AP : Alloy Primer ; 3 . MP : Monobond Plus ; 4 . MZP : Metal Zirconia Primer ; 5 . MZ : MZ Primer ; 6 . Sg : Signum Zirconia Bond ; 7 . SbU : Singlebond Universal ; 8 . ZP : Z Prime Plus . The universal primers were also used after air abrasion ( A ) of zirconia to form the following 8 groups : Ctr-A , AP-A , MP-A , MZP-A , MZ-A , Sg-A , SbU-A , and ZP-A. After ultrasonic cleaning , air abrasion was performed using Al2O3 particles ( 110 μm , 2.5 bar , 20 s at 10 mm ) in a chairside air-abrasion device . After ultrasonic cleaning again , universal primers were applied according to each manufacturer 's recommendation . The resin cement ( RelyX ARC , 3 M ESPE ) was built up incrementally and photopolymerized on the zirconia surface using a silicone mold ( Ø = 3.5 , height = 3 mm ) . All specimens were stored in distilled water ( 60 days at 37 ° C ) and then subjected to shear bond strength testing ( SBS ) in a universal testing machine ( 1 mm/min ) . On a separate set of zirconia specimens , contact angle measurements were made using the sessile drop technique with a goniometer after the application of universal primers on control and air-abraded zirconia surfaces . Data ( MPa ) were analyzed using one-way ANOVA , Tukey 's test , and Student 's t-test ( α = 0.05 ) . RESULTS When universal primers were used alone , SbU presented significantly higher mean SBS ( 19.5 ± 5.8 ) that did the other primers ( 0 to 9.9 ± 6.6 ) ( p = 0.001 ) . When air abraded , the groups AP-A ( 14.1 ± 6.1 ) , MP-A ( 15.9 ± 5.4 ) , ZP-A ( 16.9 ± 7.3 ) , SG-A ( 19.1 ± 2.1 ) , SbU-A ( 12 ± 1.5 ) showed significant differences ( p = 0.03 ) . Adhesive performance of all universal primers was enhanced after air abrasion , with the exception of the SbU and MZ primers . After air abrasion , contact angle measurements were lower for the each primer ( without air abrasion : 28.9 to 83.9 ; with air abrasion : 27.1 to 63.0 ) , except for MZP . CONCLUSION Air abrasion with 110 μm Al2O3 followed by universal primer application increased the bond strength of tested resin cement to zirconia , with the exception of SbU and MZ",
"OBJECTIVES To compare the effects of four surface coating methods on resin to zirconia shear bond strength . MATERIAL AND METHODS Eighty pre-sintered zirconia discs were prepared and r and omly divided into five study groups according to the corresponding methods of surface treatments as follows : group C ( control group , fully sintered without any surface treatment ) , group S ( fully sintered and then s and blasted with silica coated alumina powder ) , group G ( fully sintered and then coated with glazing porcelain followed by acid etching ) , group Si ( pre-coated with silica slurry then fully sintered ) , and group Z ( coated with zirconia particles and then fully sintered ) . The observation of surface morphology and elemental composition analysis were conducted by SEM and EDX . Self-adhesive resin cement stubs ( diameter 3.6 mm and height 3 mm ) were then bonded on the zirconia discs with a cylindrical shape . Both initial and artificial aged ( including 30-day water storage , thermal cycling for 3000 and 6000 cycles ) shear bond strengths were then evaluated . RESULTS All the tested coating methods showed significantly higher shear bond strengths than the control group , in both dry and aged conditions . Group S produced the strongest initial zirconia/resin bonding ( 19.7MPa ) and the control group had the lowest value ( 8.8MPa ) . However , after thermal cycling , group Z exhibited the highest mean value . All the sample s in the control group failed in the thermal cycling . Both different coating methods ( p resin-zirconia shear bond strength . CONCLUSIONS A reliable and durable resin zirconia bonding is vital for the longevity of dental restorations . Silica coating might be a reliable way in enhancing adhesion between resin and zirconia",
"OBJECTIVE This study aim ed to investigate whether or not an erbium : yttrium-aluminum-garnet ( Er : YAG ) laser could improve the bonding property of zirconia ceramics to resin cement . BACKGROUND DATA Surface treatments can improve the bonding properties of dental ceramics . However , little is known about the effect of Er : YAG laser irradiated on zirconia ceramics . MATERIAL S AND METHODS Specimens of zirconia ceramic pieces were made , and r and omly divided into 11 groups according to surface treatments , including one control group ( no treatment ) , one air abrasion group , and nine Er : YAG laser groups . The laser groups were subdivided by applying different energy intensities ( 100 , 200 , or 300 mJ ) and irradiation times ( 5 , 10 , or 15 sec ) . After surface treatments , ceramic pieces had their surface morphology observed , and their surface roughness was measured . All specimens were bonded to resin cement . Shear bond strength was measured after the bonded specimens were stored in water for 24 h , and additionally aged by thermocycling . Statistical analyses were performed using one way analysis of variance ( ANOVA ) and Tukey 's test for shear bond strength , and Dunnett 's t test for surface roughness , with α=0.05 . RESULTS Er : YAG laser irradiation changed the morphological characteristics of zirconia ceramics . Higher energy intensities ( 200 , 300 mJ ) could roughen the ceramics , but also caused surface cracks . There were no significant differences in the bond strength between the control group and the laser groups treated with different energy intensities or irradiation times . Air abrasion with alumina particles induced highest surface roughness and shear bond strength . CONCLUSIONS Er : YAG laser irradiation can not improve the bonding property of zirconia ceramics to resin cement . Enhancing irradiation intensities and extending irradiation time have no benefit on the bond of the ceramics , and might cause material defect",
"PURPOSE To evaluate the effects of a commercial zirconia primer ( Choice or RelyX Unicem ) on shear bond strength ( SBS ) of two different resin composite cements - Choice ( a conventional bis-GMA-based resin cement ) and RelyX Unicem ( self-adhesive resin cement ) - to zirconia . MATERIAL S AND METHODS Zirconia blocks were manufactured and r and omly divided into 5 main groups ( n = 20 ) that received surface treatments and cements as follows : no surface treatment , Choice and RelyX Unicem ( groups C and U , resp . ) ; tribochemical silica coating followed by silanization , Choice ( group SSC ) ; application of a zirconia primer , Choice and RelyX Unicem ( groups ZC and ZU , resp . ) . Light-curing composite resin cylinders were prepared and bonded on the prepared zirconia blocks using the two different resin cements . Half of the specimens in each group were stored in water for 24 h , and half were aged by 50 days of water storage followed by thermocycling ( 12,000 cycles between 5 ° C and 55 ° C ) . Thereafter , all of them were su bmi tted to the SBS test . Fourier transmission infrared ( FT-IR ) spectrum analysis and gas mass spectrometry ( MS ) analysis were adopted for characterization of the zirconia primer . RESULTS Statistical analysis of the SBS test showed that group C presented the lowest SBS values and group SSC the highest ( p SBS of groups U , SSC , ZC , or ZU . FT-IR analysis suggested that benzene rings and carboxylic groups exist in the zirconia primer . MS analysis detected that 2-hydroxyethyl methacrylate , triethylamine , ethyl-4-dimethylaminobenzoate , ethanol , and water are contained in the primer . CONCLUSION The zirconia primer and self-adhesive resin cement increased the SBS of zirconia",
"PURPOSE To evaluate the suitability of an ultra-short pulsed laser ( USPL ) to treat zirconia ceramic surfaces and increase their adhesion to dual-curing resin cement . MATERIAL S AND METHODS Twenty 10 × 10 × 5 mm³ blocks were prepared from a zirconia ceramic ( Y-TZP ) . The specimens were polished and r and omly assigned to four groups ( n = 5 ) which received the following surface treatments : s and blasting ( SB ) with Al₂O₃ particles and silica coating ( SC ) with SiO₂ particles as positive controls ; two groups received USPL irradiation , one with 10 scan repetitions ( L10 ) and the other with 20 ( L20 ) . Laser irradiation was performed at 1030 nm , 2.3 J/cm² , 6 ps pulse duration . The ceramic blocks were duplicated in composite resin and cemented with a dual-curing resin cement . Half of the blocks were then stored in water ( 37 ° C ) for 24 h and the other half for 1 month . At each time , 40 to 60 sticks per group were subjected to microtensile bond strength testing . Data were analyzed statistically using the Kruskal-Wallis test ( α = 0.05 ) . RESULTS Laser-treated zirconia presented statistically significantly higher roughness than did SB and SC . After 24 h , the highest bond strength means ( MPa ) were achieved by L10 ( 42.3 ± 10.8 ) and L20 ( 37.9 ± 14.4 ) , and both of them were statistically significantly higher than SB ( 22.0 ± 5.3 ) and SC ( 20.8 ± 7.1 ) ( p showed significantly higher bond strengths than did SB- and SC-treated zirconia ( p CONCLUSION USPL irradiation significantly increases bond strength of zirconia ceramic to dual-curing resin cement and might be an alternative for improving adhesion to this material",
"This study evaluated the effectiveness of a multi-mode adhesive ( SBU-Scotch Bond Universal/3 M ) as a substitute for silica coating and silane application on the bonding of zirconia ceramics to resin cement . One-hundred and twenty sintered zirconia ceramic blocks ( 5 x 5 x 5 mm ) were obtained , finished by grounding with silicon carbide paper ( # 600 , # 800 , # 1000 and # 1200 ) and r and omly divided into 12 groups ( n=10 ) in accordance with the factors \" surface treatment \" ( ScSi - silicatization + silanization ; ScSBU - silicatization + SBU ; SBU - SBU without photoactivation and SBUp - SBU photoactivated ) and \" ceramic \" ( Lava / 3 M ESPE , Ceramill Zirconia / Amann Girrbach and Zirkonzahn / Zirkonzahn ) . Dual resin cement cylinders ( RelyX Ultimate/3 M ESPE ) were subsequently produced in the center of each block using a silicon matrix ( Ø=2 mm , h=5 mm ) and photoactivated for 40 s ( 1200 mW/cm2 ) . The sample s were stored for 30 days in distilled water ( 37ºC ) and su bmi tted to shear bond strength test ( 1 mm/min , 100 KgF ) . Data ( MPa ) were analyzed under ANOVA ( 2 levels ) and Tukey test ( 5 % ) . Complementary analyzes were also performed . ANOVA revealed that only the factor \" surface treatment \" was significant ( p=0.0001 ) . The ScSi treatment ( 14.28A ) promoted statistically higher bond strength values than the other ScSBU ( 9.03B ) , SBU ( 8.47B ) and SBUp ( 7.82B ) , which were similar to each other ( Tukey ) . Failure analysis revealed that 100 % of the failures were mixed . The silica coating followed by the silanization promoted higher bond strength values of resin cement and ceramic , regardless of the zirconia ceramic or SBU"
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41180aae-06ff-11f0-808a-c43d1ab1c353
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Direct post- and -core restorations with prefabricated posts are becoming increasingly popular . A literature review was conducted to compare the clinical and in vitro performance of cast posts and cores to that of direct cores with prefabricated posts in single-rooted teeth . Research on the restoration of endodontically treated teeth was identified through a search of electronic data bases . The search yielded a total of 1773 references . After these references were subjected to strict inclusion criteria , 10 in vitro and 6 in vivo studies remained and critically review ed . A comparison of fracture loads in the in vitro studies revealed no significant difference between cast and direct posts and cores . Meta- analysis of the data suggested that there is no difference in fracture behavior associated with the 2 treatment modalities . An overall survival analysis was not possible for the in vivo studies . The survival for cast posts and cores in 2 studies ranged from 87.2 % to 88.1 % and in a third study reached 86.4 % for direct cores after 72 months . R and omized clinical trials on this topic were not available but should be conducted to verify published findings
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[
"PURPOSE This study compares the survival rate and fracture strength of endodontically treated maxillary incisors with moderate coronal defects restored with different post- and -core systems after exposure to an artificial mouth . MATERIAL S AND METHODS Sixty-four caries-free human maxillary central incisors were selected for st and ardized size and quality , endodontically treated , and decoronated 2 mm coronal to the cementoenamel junction . Group 1 was restored with titanium posts and composite cores , group 2 received zirconia posts and a composite core , and in group 3 zirconia posts with a heat-pressed ceramic core were used . Teeth restored with cast posts and cores served as controls . All teeth were prepared and restored with complete cast crowns . All sample s were exposed to 1.2 million cycles in a computer-controlled chewing simulator with simultaneous thermocycling . In addition , the sample s were loaded until fracture in a static testing device . RESULTS The survival rates of the different groups were : 94 % for titanium/composite , 63 % for zirconia/composite , 100 % for the all-ceramic post and core , and 94 % for the cast post and core . The following mean fracture strengths were obtained : titanium/composite = 425 + /- 155 N , zirconia/composite = 202 + /- 212 N , zirconia/ceramic = 378 + /- 64 N , cast post and core = 426 + /- 178 N. The lower fracture load in the group with zirconia posts and composite cores was statistically significant . The use of zirconia posts result ed in fewer oblique root fractures . CONCLUSION Prefabricated titanium posts with composite cores , zirconia posts with heat-pressed ceramic cores , and cast posts and cores yield comparable survival rates and fracture strengths for the restoration of crowned maxillary incisors with moderate coronal defects . Survival rates and fracture strengths for zirconia posts with composite cores are significantly lower , so this combination can not be recommended for clinical use",
"STATEMENT OF PROBLEM A self-contained post and core system , Composipost , comprising an epoxy-based carbon fiber post , a composite core material , and a low viscosity Bis-GMA bonding resin , has recently been marketed for the restoration of pulpless teeth . PURPOSE This study compared the in vitro performance and the failure characteristics of the Composipost system against existing post and core combinations . MATERIAL AND METHODS Using extracted human teeth , three post and core test groups and one control group were then tested to failure with an obliquely applied compressive load at 130 degrees in a Hounsfield testing-machine with a crosshead speed of 5 cm/minute . RESULTS The mean stress values at failure ( MNm.2 ) with st and ard deviations for each group were as follows : Composipost system 8.89 , SD 2.40 ; stainless steel post and composite core 14.18 , SD 3.49 ; cast gold alloy post and gold alloy core 15.25 , SD 4.07 ; and endodontically treated tooth only 24.84 SD 4.58 . CONCLUSION The specimens restored with the Composipost system exhibited inferior strength properties in comparison to the other post and core systems tested ( p < 0.01 ) . Teeth without post and core foundations tested significantly stronger than the other comparison groups ( p < 0.01 )"
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41180b4e-06ff-11f0-808a-c43d1ab1c353
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Objective : An adequate wheelchair propulsion capacity is required to perform daily life activities . Exercise training may be effective to gain or improve wheelchair propulsion capacity . This review investigates whether different types of exercise training programs are effective in improving wheelchair propulsion capacity . Data sources : PubMed and EMBASE data bases were search ed from their respective inceptions in October 2013 . Review methods : Exercise training studies with at least one outcome measure regarding wheelchair propulsion capacity were included . In this study wheelchair propulsion capacity includes four parameters to reflect functional wheelchair propulsion : cardio-respiratory fitness ( aerobic capacity ) , anaerobic capacity , muscular fitness and mechanical efficiency . Articles were not selected on diagnosis , training type or mode . Studies were divided into four training types : interval , endurance , strength , and mixed training . Method ological quality was rated with the PEDro scale , and the level of evidence was determined . Results : The 21 included studies represented 249 individuals with spinal-cord injury ( 50 % ) , various diagnoses like spina bifida ( 4 % ) , cerebral palsy ( 2 % ) , traumatic injury , ( 3 % ) and able-bodied participants ( 38 % ) . All interval training studies found a significant improvement of 18 - 64 % in wheelchair propulsion capacity . Three out of five endurance training studies reported significant effectiveness . Method ological quality was generally poor and there were only two r and omised controlled trials . Conclusion : Exercise training programs seem to be effective in improving wheelchair propulsion capacity . However , there is remarkably little research , particularly for individuals who do not have spinal-cord injury
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"A quasi-experimental longitudinal design was used to compare pre- and posttraining biomechanical and physiological characteristics of wheelchair propulsion in manual wheelchair users ( MWCU ) across fresh and fatigue states . An instrumented wheelchair ergometer , 3D motion analysis , and computerized open-circuit spirometry were used to collect joint kinetics and kinematics , h and rim kinetics , propulsion temporal characteristics , and oxygen uptake pre- and posttraining during a submaximal exercise test to exhaustion . Each subject ( n = 19 ) participated in a specific intervention program of supervised therapeutic exercise ( strengthening , stretching , and aerobic exercise ) for 6 weeks . Pre- and posttraining measurements were compared with the use of ANOVA with repeated measures . Significant training effects included increased exercise loads for all strengthening activities , decreased stroke frequency , increased maximum elbow extension angle , increased trunk and shoulder flexion/extension range of motion ( ROM ) , increased h and rim propulsive moment , increased wrist extension moment , and increased power output . Results suggest that this training program increased biomechanical economy ( as defined by propulsive moment ) without increasing shoulder or elbow joint stresses",
"PURPOSE The purpose of this study was to study the effects of a 7-wk wheelchair training program on physical work capacity in able-bodied subjects . Effects of training intensities of 50 and 70 % heart rate ( HR ) reserve ( HRR ) were studied for different subject groups . METHODS Twenty-seven able-bodied male subjects participated in this study . They were r and omly divided into a control group ( N = 8) , a 50%-intensity group ( N = 9 ) , and a 70%-intensity group ( N = 10 ) . The 50%- and the 70%-intensity groups received a 7-wk wheelchair training program : three times a week , one-half hour wheelchair exercise on a motor driven treadmill at an average intensity of 50 and 70 % of the HRR , respectively . Before and after the training period , parameters for physical work capacity ( maximal isometric strength ( Fiso ) , sprint power ( P30 ) , maximal power output ( POmax ) and peak oxygen uptake ( VO2peak ) ) , and submaximal performance ( mechanical efficiency , HR ) at 20 and 40 % of the estimated POmax ( ME20 , ME40 ; HR20 , HR40 ) were obtained during tests on a stationary wheelchair ergometer . RESULTS A two-factor ANOVA for repeated measures on the within-subjects factor \" pre-post tests , \" the between-subject factor training ( 50 % and 70 % training vs control ) and the interaction term showed that the 50%-intensity group significantly increased on P30 and POmax compared with the control group . The 70 % intensity group significantly increased on P30 , POmax and VO2peak compared with the control group ( P P30 and POmax over training than the 50 % intensity . No significant effects were found for the Fiso and the parameters at submaximal PO . CONCLUSIONS The wheelchair training at both intensities can have favorable effects on maximal physical work capacity in able-bodied subjects , and possibly also on mechanical efficiency at submaximal power output . Effects are seen in parameters for both aerobic and anaerobic work capacities . Although training at 70 % intensity was more effective than the 50 % intensity , training at 50 % HRR may initially be more appropriate in untrained individuals , such as novice wheelchair users at the start of their rehabilitation , to prevent fatigue and enhance motivation",
"Study design : A prospect i ve cohort study . Objectives : To study the longitudinal relationship between objective ly measured everyday physical activity level , and physical fitness and lipid profile in persons with a recent spinal cord injury ( SCI ) . Setting : A rehabilitation centre in the Netherl and s and the participant 's home environment . Methods : Data of 30 persons with a recent SCI were collected at the start of active rehabilitation , 3 months later , at discharge from inpatient rehabilitation , and 1 year after discharge . Physical activity level ( duration of dynamic activities as % of 24 h ) was measured with an accelerometry-based activity monitor . Regarding physical fitness , peak oxygen uptake ( VO2peak ) and peak power output ( POpeak ) were determined with a maximal wheelchair exercise test , and upper extremity muscle strength was measured with a h and held dynamometer . Fasting blood sample s were taken to determine the lipid profile . Results : An increase in physical activity level was significantly related to an increase in VO2peak and POpeak , and an increase in physical activity level favourably affected the lipid profile . A nonsignificant relation was found with muscle strength . Conclusion : Everyday physical activity seems to have an important role in the fitness and health of persons with a recent SCI . An increase in physical activity level was associated with an increase in physical fitness and with a lower risk of cardiovascular disease",
"OBJECTIVE To study the longitudinal relation between physical capacity and wheelchair skill performance in subjects with spinal cord injury ( SCI ) during rehabilitation . DESIGN Observational prospect i ve cohort study . Measurements were taken 3 times during subjects ' rehabilitation . SETTING Eight rehabilitation centers in the Netherl and s. PARTICIPANTS Ninety-seven subjects with SCI . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Parameters of physical capacity were upper-extremity muscle strength ( manual muscle test [ MMT ] sum score ) , peak oxygen uptake , and peak power output ( POpeak ) . The Wheelchair Circuit consists of 8 wheelchair skills and results in 3 test scores : ability , performance time , and physical strain . RESULTS POpeak was related to all 3 scores of the Wheelchair Circuit , and the MMT sum score was related to the ability score and the performance time score . The results indicate that ( 1 ) subjects with higher values of POpeak and /or the MMT sum score had better scores on the Wheelchair Circuit than subjects with lower values and ( 2 ) when a subject increased his/her POpeak and /or MMT sum score , this was associated with better wheelchair skill scores . CONCLUSIONS There is a significant longitudinal relation between wheelchair skill performance and POpeak and MMT sum score during the rehabilitation of people with SCI . To optimize wheelchair skill performance , attention should be directed toward manual wheelchair exercise training and strength training of the upper body",
"Background There is considerable evidence that respiratory muscle training improves pulmonary function , quality of life and exercise performance in healthy athletic population s. The benefits for wheelchair athletes are less well understood . Therefore , in the present study , influence of inspiratory muscle training ( IMT ) on respiratory function and repetitive propulsive sprint performance in wheelchair basketball players was examined . Methods Using a placebo-controlled design , 16 wheelchair athletes were divided to an experimental ( IMT ; n=8 ) or placebo ( sham-IMT ; n=8 ) group based on selective grouping criteria . 30 dynamic breaths were performed by the IMT group twice daily at a resistance equivalent to 50 % maximum inspiratory pressure ( MIP ) , and 60 slow breaths were performed by the sham-IMT group once a day at 15 % MIP for a period of 6 weeks . Results In the IMT group , both MIP and maximum expiratory pressure ( 17 % and 23 % , respectively ; p≤0.03 ) were improved . Similar improvements were noted for the sham-IMT group with 23 % and 33 % from baseline for MIP and maximum expiratory pressure , respectively ( p≤0.03 ) . There were no significant changes in pulmonary function at rest and any of the performance parameters associated with the repetitive sprint test ( sprint and recovery times , peak heart rate and peak blood lactate concentration ) . Reported experiences of using the IMT training device suggested “ less breathlessness ” and “ less tightness in the chest during the training ” . Conclusions Although there was no improvement in sprint performance , an improved respiratory muscle function and quality of life were reported by participants in both the IMT and sham-IMT groups",
"Purpose . To simulate the effect of low-intensity exercise in early rehabilitation , we investigated the effect of a 7-week low-intensity norm duration h and rim wheelchair training on the physical capacity in untrained able-bodied individuals . Method . Twenty-five able-bodied participants were r and omly assigned to an experimental and control group : 10 participants exercised 7 weeks , three times a week at 30 % heart rate reserve ( HRR ) for 30 min ( experimental group ) . The control group consisted of 15 participants who did not receive training . Physical capacity ( maximal isometric strength , sprint power , peak power output and peak oxygen uptake ) and submaximal performance [ heart rate ( HR ) , oxygen uptake ( VO2 ) , mechanical efficiency ( ME ) ] were assessed pre- and post-training . The levels of upper-body discomfort were determined with the use of a Local Perceived Discomfort scale . Results . Compared to the control group the experimental group significantly improved on sprint power ( + 31.2 % ) , peak aerobic power output ( + 34 % ) , submaximal HR , VO2 and ME ( + 16.9 % ) . The participants did not experience high levels of local discomfort in the upper body during the training . Conclusions . Low-intensity norm duration h and rim wheelchair training which significantly improved peak aerobic and sprint power output , efficiency and physical strain in able-bodied untrained individuals . Training at 30 % HRR ( 3 × /week , 30 min/session ) may be appropriate in untrained individuals , such as novice wheelchair users at the start of their rehabilitation , to prevent early fatigue and overuse and enhance motivation . Please note that this article was published in error in a previous issue of the Journal . This paper was su bmi tted and accepted as part of the Special Issue entitled 4th International State-of-the-art-Congress ‘ Rehabilitation : Mobility , Exercise & Sports ’ and has therefore been republished in this issue . The publisher apologises for this error",
"PURPOSE The present study compared the effects of aerobic endurance training at different intensities and with different methods matched for total work and frequency . Responses in maximal oxygen uptake ( VO2max ) , stroke volume of the heart ( SV ) , blood volume , lactate threshold ( LT ) , and running economy ( CR ) were examined . METHODS Forty healthy , nonsmoking , moderately trained male subjects were r and omly assigned to one of four groups:1 ) long slow distance ( 70 % maximal heart rate ; HRmax ) ; 2)lactate threshold ( 85 % HRmax ) ; 3 ) 15/15 interval running ( 15 s of running at 90 - 95 % HRmax followed by 15 s of active resting at 70 % HRmax ) ; and 4 ) 4 x 4 min of interval running ( 4 min of running at 90 - 95 % HRmax followed by 3 min of active resting at 70%HRmax ) . All four training protocol s result ed in similar total oxygen consumption and were performed 3 d.wk for 8 wk . RESULTS High-intensity aerobic interval training result ed in significantly increased VO2max compared with long slow distance and lactate-threshold training intensities ( P V O2max from 60.5 to 64.4 mL x kg(-1 ) x min(-1 ) and 55.5 to 60.4 mL x kg(-1 ) x min(-1 ) . SV increased significantly by approximately 10 % after interval training ( P High-aerobic intensity endurance interval training is significantly more effective than performing the same total work at either lactate threshold or at 70 % HRmax , in improving VO2max . The changes in VO2max correspond with changes in SV , indicating a close link between the two",
"Background : Various combinations of training intensity , duration and frequency are often proposed to people with spinal cord injuries in order to improve their fitness . However , no consensus about a specific training program has been reached for such a population . Objective : This study investigated the effects of a short interval training program specifically design ed for patients with spinal cord injuries . Methods : Paraplegic men performed 30-min wheelchair ergometry three times per week , for 4 weeks . Maximal dynamic performance and endurance capacity were studied before and after the training program with an incremental test ( 10 W/2 min ) until volitional fatigue and a constant work rate test , respectively . Cardiorespiratory responses were continuously studied during each of these tests . Results : Training induced significant improvement in maximal tolerated power ( + 27.9 % ) , and in peak oxygen consumption ( [ Vdot ] O2 , + 18.5 % ) . After training the subjects were able to maintain the load applied during the constant test ( total mechanical work + 210.7 % ) , for a significantly longer time . The heart rate , [ Vdot ] O2 and ventilation values observed when the volunteers ended their first constant load test were significantly higher ( + 10 % , + 10 % , + 40 % respectively ) than those obtained after a similar time period during the second constant load test which was performed after the training program . Conclusion : After this short training period , with an appropriate combination of different types of training , duration , intensity and frequency exercises , we observed a significant improvement in the fitness level and endurance capacity of paraplegic subjects . Spinal Cord ( 2001 ) 39 , 532–537",
"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",
"The purpose of the present study was to examine both the specific and the transfer effects of a Square Wave Endurance Exercise Test ( SWEET ) and to investigate the determining factors of transfer effect . A control group ( CG , n = 5 ) and 2 experimental groups were studied . Experimental groups completed 3 days/week a 45 min SWEET over 6 weeks , either with the arms using a wheelchair ergometer ( AG , n = 5 ) or with the legs using a cycling ergometer ( LG , n = 5 ) . All subjects performed before and after training two maximal progressive tests : the first one with the arms and the second with the legs . During those tests oxygen uptake ( VO(2 ) ) and cardiorespiratory parameters were continuously measured . Specific effects ( changes between the tests performed with trained limbs ) were observed : the peak power output ( W(p ) ) and VO(2 ) were significantly increased by both arm ( + 66 % , + 35 % ) and leg ( + 17 % , + 14 % ) training . At ventilatory threshold ( VT ) , power output ( W ) and VO(2 ) were significantly increased with arm ( + 145 % and + 51 % ) and leg ( + 53 % and + 46 % ) training . Transfer effects ( changes between pre and post tests performed with untrained limbs ) were observed : W(p ) and VO(2 ) were not increased in AG while W(p ) was increased in LG ( + 11 % ) . At VT , W and VO(2 ) were increased with arm ( + 19 % and + 23 % ) and leg ( + 33 % and + 46 % ) training . For AG and LG the VO(2 ) expressed in percent of the VO(2 ) peak was increased ( + 19 % and + 33 % , respectively ) and the O(2p ) was also increased ( + 30 % ) for LG . These results show that SWEET training induced specific and transfer effects . Moreover , the initial level of the subjects , the type and the intensity of the training seem to be the major factors for effective observable transfer effects",
"Study design : Time series design . Objectives : To determine the effects of a shoulder resistance training programme on isokinetic and isometric strength , body composition , pain and functionality in paraplegic subjects . Setting : University of Valencia , Valencia , Spain . Methods : A total of 15 subjects with thoracic spinal cord injury ( SCI ) performed three testing sessions with an 8-week period between the sessions . Subjects were not disturbed between the first and the second testing sessions . Subjects performed an 8-week resistance training programme after the second testing session . Variations in isometric and isokinetic shoulder muscle strength , body composition , reported pain and shoulder functionality were evaluated . Results : The training programme produced a significant increase ( P the isometric and isokinetic strength of several shoulder movements as well as an increase ( P in arm fat-free mass and a decrease in arm fat mass ( FM ) . Furthermore , reported pain was decreased , ( P upper-limb functionality was increased ( P Implementing resistance training programmes as physical therapy in SCI subjects effectively increases strength , muscle mass and upper-limb functionality , whereas decreasing FM and pain perception",
"Effects of two 9-month sports programmes ( four or two sessions per week ) on level of daily physical activity ( PA ) , fat mass ( FM ) , and physical fitness were assessed in children with spastic cerebral palsy ( CP ; n = 20 , 9.2 + /- 1.4 yr ) , r and omly assigned to an experimental and control group after matching . Four sessions per week tended to increase PA ratio ( 24-h energy expenditure/sleeping ( resting ) energy expenditure ) after 9 months from 1.34 + /- 0.25 to 1.55 + /- 0.18 ( P = 0.07 ; not different versus controls ) . FM increased continuously in the control group ( after 9 months + 1.1 + /- 1.6 kg , P Training ( respectively four and two sessions ) increased peak aerobic power 35 % ( P isokinetic muscle strength . No training-related effects were found on anaerobic power . It was concluded that although aerobic training has a limited effect on PA in children with CP , it may prevent deterioration in body composition and muscle strength . Furthermore , training has a favourable effect on peak aerobic power"
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BACKGROUND Attention deficit hyperactivity disorder ( ADHD ) is a chronic neurodevelopmental disorder of childhood onset , which may persist into adulthood . ADHD has a significant impact on a child 's daily life , affecting relationships and academic performance . Its core symptoms include developmentally inappropriate levels of inattention , hyperactivity , and impulsive behaviour . Tricyclic antidepressants ( TCAs ) are sometimes used as second line of treatment in the reduction of ADHD symptoms in children and adolescents with ADHD . However , their efficacy is not yet known . OBJECTIVES To assess the efficacy of TCAs in the reduction of ADHD symptoms within the broad categories of hyperactivity , impulsivity , and inattentiveness in young people aged 6 to 18 years with established diagnoses of ADHD . SEARCH METHODS On 26 September 2013 , we search ed CENTRAL , Ovid MEDLINE , Embase , PsycINFO , CINAHL , seven other data bases , and two trials registers . We also search ed the reference lists of relevant articles , and contacted manufacturers and known experts in the field to determine if there were any ongoing trials or unpublished studies available . SELECTION CRITERIA R and omised controlled trials ( RCTs ) , including both parallel group and cross-over study design s , of any dose of TCA compared with placebo or active medication in children or adolescents with ADHD , including those with comorbid conditions . DATA COLLECTION AND ANALYSIS Working in pairs , three review authors independently screened records , extracted data , and assessed trial quality . We calculated the st and ardised mean differences ( SMD ) for continuous data , the odds ratio ( OR ) for dichotomous data , and 95 % confidence intervals ( CIs ) for both . We conducted the meta-analyses using a r and om-effects model throughout . We used the Cochrane ' Risk of bias ' tool to assess the risk of bias of each included trial and the GRADE approach to assess the quality of the body evidence . MAIN RESULTS We included six RCTs with a total of 216 participants . Five of the six trials compared desipramine with placebo ; the remaining trial compared nortriptyline with placebo . One trial compared desipramine with clonidine and placebo , and another compared two TCAs ( desipramine and clomipramine ) with methylpheni date and placebo . Of the six trials , one RCT primarily assessed the efficacy of TCA in children with ADHD and comorbid tic or Tourette disorder , and another one trial was in children with comorbid tic disorder . RCTs that met our inclusion criteria varied both in design and quality , and none were free of bias . The quality of the evidence was low to very low according to our GRADE assessment s . TCA outperformed placebo regarding the proportions of patients achieving a predefined improvement of core ADHD symptom severity ( OR 18.50 , 95 % CI 6.29 to 54.39 , 3 trials , 125 participants , low quality evidence ) . In particular , there was evidence that desipramine improved the core symptoms of ADHD in children and adolescents as assessed by parents ( SMD -1.42 , 95 % CI -1.99 to -0.85 , 2 trials , 99 participants , low quality evidence ) , teachers ( SMD -0.97 , 95 % CI -1.66 to -0.28 , 2 trials , 89 participants , low quality evidence ) , and clinicians ( OR 26.41 , 95 % CI 7.41 to 94.18 , 2 trials , 103 participants , low quality evidence ) . Nortriptryline was also efficacious in improving the core symptoms of ADHD in children and adolescents as assessed by clinicians ( OR 7.88 , 95 % CI 1.10 to 56.12 ) . Desipramine and placebo were similar on " all-cause treatment discontinuation " ( RD -0.10 , 95 % CI -0.25 to 0.04 , 3 trials , 134 participants , very low quality evidence ) . Desipramine appeared more efficacious than clonidine in reducing ADHD symptoms as rated by parents ( SMD -0.90 , 95 % CI -1.40 to -0.40 , 1 trial , 68 participants , very low quality evidence ) in participants with ADHD and comorbid tics or Tourette syndrome . Although this Cochrane Review did not identify serious adverse effects in patients taking TCAs , it did identify mild increases in diastolic blood pressure and pulse rates . Also , patients treated with desipramine had significantly higher rates of appetite suppression compared to placebo whilst nortriptyline result ed in weight gain . Other reported adverse effects included headache , confusion , sedation , tiredness , blurred vision , diaphoresis , dry mouth , abdominal discomfort , constipation , and urinary retention . AUTHORS ' CONCLUSIONS Most evidence on TCAs relates to desipramine . Findings suggest that , in the short term , desipramine improves the core symptoms of ADHD , but its effect on the cardiovascular system remains an important clinical concern . Thus , evidence supporting the clinical use of desipramine for the treatment of children with ADHD is low
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"SUMMARY A controlled investigation was conducted to assess the relative effectiveness of amitriptyline and methylpheni date for treating hyperactive/aggressive behavior in children originally referred to a learning clinic . Behavioral change was measured through parent and teacher ratings . Drug effects on attention , short term memory , and impulsivity were evaluated with laboratory tasks . It was found that both drugs were largely comparable in attenuating hyperactivity and aggression . Of the laboratory measures , only attention was improved by both drugs . However , neither medication interfered with functioning on the other laboratory tests . With the exception of and trip by line-induced sedation , side effects were of minor degree . Findings raised questions concerning measuring and improving attentiveness . Differences between results of this and other studies were discussed , as were issues regarding pharmacotherapy with amitriptyline in children",
"BACKGROUND Previous studies have demonstrated the short-term efficacy of pharmacotherapy and behavior therapy for attention-deficit/hyperactivity disorder ( ADHD ) , but no longer-term ( i.e. , > 4 months ) investigations have compared these 2 treatments or their combination . METHODS A group of 579 children with ADHD Combined Type , aged 7 to 9.9 years , were assigned to 14 months of medication management ( titration followed by monthly visits ) ; intensive behavioral treatment ( parent , school , and child components , with therapist involvement gradually reduced over time ) ; the two combined ; or st and ard community care ( treatments by community providers ) . Outcomes were assessed in multiple domains before and during treatment and at treatment end point ( with the combined treatment and medication management groups continuing medication at all assessment points ) . Data were analyzed through intent-to-treat r and om-effects regression procedures . RESULTS All 4 groups showed sizable reductions in symptoms over time , with significant differences among them in degrees of change . For most ADHD symptoms , children in the combined treatment and medication management groups showed significantly greater improvement than those given intensive behavioral treatment and community care . Combined and medication management treatments did not differ significantly on any direct comparisons , but in several instances ( oppositional/aggressive symptoms , internalizing symptoms , teacher-rated social skills , parent-child relations , and reading achievement ) combined treatment proved superior to intensive behavioral treatment and /or community care while medication management did not . Study medication strategies were superior to community care treatments , despite the fact that two thirds of community-treated subjects received medication during the study period . CONCLUSIONS For ADHD symptoms , our carefully crafted medication management was superior to behavioral treatment and to routine community care that included medication . Our combined treatment did not yield significantly greater benefits than medication management for core ADHD symptoms , but may have provided modest advantages for non-ADHD symptom and positive functioning outcomes",
"OBJECTIVE This study examined the efficacy and safety of clonidine hydrochloride extended-release tablets ( CLON-XR ) in children and adolescents with attention-deficit/hyperactivity disorder ( ADHD ) . METHOD This 8-week , placebo-controlled , fixed-dose trial , including 3 weeks of dose escalation , of patients 6 to 17 years old with ADHD evaluated the efficacy and safety of CLON-XR 0.2 mg/day or CLON-XR 0.4 mg/day versus placebo in three separate treatment arms . Primary endpoint was mean change in ADHD Rating Scale-IV ( ADHD-RS-IV ) total score from baseline to week 5 versus placebo using a last observation carried forward method . Secondary endpoints were improvement in ADHD-RS-IV inattention and hyperactivity/impulsivity subscales , Conners Parent Rating Scale-Revised : Long Form , Clinical Global Impression of Severity , Clinical Global Impression of Improvement , and Parent Global Assessment from baseline to week 5 . RESULTS Patients ( N = 236 ) were r and omized to receive placebo ( n = 78 ) , CLON-XR 0.2 mg/day ( n = 78 ) , or CLON-XR 0.4 mg/day ( n = 80 ) . Improvement from baseline in ADHD-RS-IV total score was significantly greater in both CLON-XR groups versus placebo at week 5 . A significant improvement in ADHD-RS-IV total score occurred between groups as soon as week 2 and was maintained throughout the treatment period . In addition , improvement in ADHD-RS-IV inattention and hyperactivity/impulsivity subscales , Conners Parent Rating Scale-Revised : Long Form , Clinical Global Impression of Improvement , Clinical Global Impression of Severity , and Parent Global Assessment , occurred in both treatment groups versus placebo . The most common treatment-emergent adverse event was mild-to-moderate somnolence . Changes on electrocardiogram were minor and reflected the known pharmacology of clonidine . CONCLUSIONS Clonidine hydrochloride extended-release tablets were generally well tolerated by patients in the study and significantly improved ADHD symptoms in this pediatric population",
"BACKGROUND Despite long-st and ing clinical concerns , relatively little is known about the comorbidity between attention-deficit/hyperactivity disorder ( ADHD ) and tic disorders . Therefore , we examined tic disorders in an ongoing prospect i ve follow-up study of male subjects with ADHD , a sample unselected for any comorbid disorder . METHODS One hundred twenty-eight male children and adolescents with ADHD and 110 male controls were comprehensively evaluated at baseline and 4 years later . We characterized tic disorders along with a wide range of neuropsychiatric correlates , including other comorbid disorders and indices of psychosocial function in multiple domains ( school , cognitive , social , and family ) . RESULTS Compared with controls , subjects with ADHD showed more tic disorders at baseline and more new onsets were reported at follow-up . Attention-deficit/hyperactivity disorder and tic disorders appeared to be independent in course : in contrast to low rates of ADHD remission , tic disorders mostly remitted . The age-adjusted rate of ADHD remission was 20 % and that of tic remission , 65 % . Tic disorders had little effect on the psychosocial functioning of subjects with ADHD . CONCLUSIONS These findings suggest that comorbidity with a tic disorder has a limited effect on ADHD outcome . However , because of the relatively small sample of subjects with tic disorders , our conclusions should be considered preliminary until confirmed in larger studies of medicated and unmedicated children with ADHD with and without tic disorders",
"The objective of this study was to investigate the effects of methylpheni date ( MPH ) on attention and inhibition in children with Attention Deficit Hyperactivity Disorder ( ADHD ) and to establish what the relative contributions of the noradrenergic and dopaminergic systems to this effect were . In addition to MPH , two other drugs were administered in order to affect both transmitter systems more selectively , L-dopa ( dopamine ( DA ) agonist ) and desipramine ( DMI ) ( noradrenaline ( NA ) re-uptake inhibitor ) . Sixteen children with ADHD performed a stop-task , a laboratory task that measures the ability to inhibit an ongoing action , in a double-blind r and omized within-subjects design . Each child received an acute clinical dose of MPH , DMI , L-dopa , and placebo ; measures of performance and plasma were determined . The results indicated that inhibition performance was improved under DMI but not under MPH or L-dopa . The response-time to the stop-signal was marginally shortened after intake of DMI . MPH decreased omission and choice-errors and caused faster reaction times to the trials without the stop-tone . No effects of L-dopa whatsoever were noted . Prolactin levels were increased and 5-HIAA levels were lowered under DMI relative to placebo . It is suggested that the effects of MPH on attention are due to a combination of noradrenergic and dopaminergic mechanisms . The improved inhibition under DMI could be serotonergically mediated",
"BACKGROUND Four cases of sudden death in children 12 years or younger during desipramine treatment were identified between 1986 and 1992 . We evaluated whether these events support the hypothesis that exposure to therapeutic doses of desipramine contributes to the risk for sudden death in otherwise healthy children . METHOD The National Center for Health Statistics provided the baseline number of sudden unexplained deaths in children 5 to 14 years old . Data from the National Disease and Therapeutic Index were used to estimate the exposure to desipramine in children in the same age group . Since two of the four deaths were identified by 1987 , we used the post-1987 experience as if it were a prospect i ve period in which a causal association could be examined . RESULTS The number of sudden deaths in desipramine-exposed children did not increase from 1986 to 1992 despite a marked increase in exposure . By using 4 to 6 months as the average lifetime of a desipramine prescription and a baseline rate of sudden death of 4.2 deaths/million/year in this population , the post-1987 period would account for 162,000 to 242,000 person-years of desipramine exposure . Although not statistically significant , this level of exposure corresponds to a relative risk of 2.1 ( 95 % CI = 0.5 to 15 ) to 3.1 ( 95 % CI = 0.8 to 22 ) . CONCLUSION Although , based on our estimates , the evidence for an association between desipramine and sudden death in children aged 5 to 14 years appears weak , replication of our findings is needed with a more precise numerator ( total number of deaths ) and denominator ( the appropriate conversion from drug appearance to actual exposure ) before a firm conclusion on this subject can be drawn . Until then , even if remote , the possibility of an association between desipramine and sudden death in children stresses the importance of assessing risks and benefits when desipramine is used in pediatric patients",
"OBJECTIVES To study the efficacy and tolerability of nortriptyline ( NT ) in the treatment of pediatric attention deficit hyperactivity disorder ( ADHD ) . METHODOLOGY Subjects were outpatient children and adolescents with ADHD ascertained from clinical referrals . Subjects were enrolled in a 6-week open study in which NT was titrated to 2 mg/kg/day as tolerated over 2 weeks . Using either a 30 % reduction in the ADHD rating scale or a score of 1 or 2 on the Clinical Global Impression ( CGI ) scale for ADHD improvement , responders to treatment were then r and omized into a 3-week , controlled discontinuation phase . During this phase , subjects either continued on their current dose of NT or were tapered to placebo under double-blind conditions . Subjects were monitored for symptoms of ADHD , oppositionality , anxiety , and depression . RESULTS Of the 35 subjects enrolled in the study , 32 completed the open phase and 23 completed the discontinuation phase . The mean dose of NT was 80 mg ( 1.8 mg/kg/day ) , result ing in a serum level of 81 ng/ml . At the conclusion of the open 6-week study , NT was related to a significant reduction in ADHD ( p oppositional symptoms ( p scores on the DSM-IV ADHD symptom checklist than those 11 subjects r and omized to placebo ( 31 versus 21 ; t = 2.2 ; p adverse events were observed , and children were noted to have weight gain during the trial . CONCLUSIONS These data suggest that NT is effective in reducing symptoms not only of ADHD but also of oppositionality . This group of children and adolescents tolerated robust dosing of NT well , with few clinical or cardiovascular adverse events",
"This community-based study was design ed to evaluate treatment outcomes with OROS ® methylpheni date ( MPH ) and atomoxetine in children with attentiondeficit/hyperactivity disorder ( ADHD ) , as assessed by physicians and parents in a setting that resembles clinical practice . In a multicenter , prospect i ve , open-label study , children 6 to 12 years of age with ADHD were r and omized ( 2:1 , respectively ) to 3 weeks of treatment with once-daily OROS MPH or atomoxetine . Investigatorrated measures of symptoms included the ADHD Rating Scale ( ADHD-RS ) and the Clinical Global Impression-Improvement of Illness scale ( CGI-I ) . Assessment s were made at baseline and during a telephone interview in week 1 , a clinic visit in week 2 , and a final clinic visit in week 3 . In total , 1323 patients received OROS MPH ( n=850 ) or atomoxetine ( n=473 ) . Significant reductions from baseline in investigator-evaluated ADHD-RS scores were observed among patients receiving OROS MPH and those receiving atomoxetine . At the end of the study , mean decreases from baseline ADHD-RS scores were 20.24 for OROS MPH and 16 for atomoxetine ( P 3 , respectively ; P ( ie , 25 % reduction from baseline ADHD-RS scores ) was significantly greater at each evaluation for patients taking OROS MPH than for those taking atomoxetine ( P taking OROS MPH ( 4.8 % ) and atomoxetine ( 5.5 % ) withdrew because of adverse events . Although community-based studies often lack the control of r and omized , placebo-controlled trials , these results nevertheless suggest greater ADHD symptom improvement with OROS MPH compared with atomoxetine",
"Twenty‐nine boys with attention deficit disorder/hyperactivity were r and omly assigned to receive desipramine ( DMI ; n = 17 ) or placebo ( n = 12 ) for 14 days in a noncrossover , double‐blind study . There was immediate behavioral improvement with DMI at day 3 that was sustained for 2 weeks ; behavioral improvement did not correlate with plasma concentrations of DMI , hydroxy‐DMI , or their sum at either days 3 or 14 . There were no untoward side effects ; there was a drug‐induced increase in pulse and diastolic blood pressure . During drug therapy , the urinary excretion of norepinephrine , vanillym and elic acid , and 3‐methoxy‐4‐hydroxyphenylglycol ( MHPG ) was decreased at both days 3 and 14 . The plasma MHPG level was decreased at days 3 and 14 and ( st and ing ) plasma NE levels increased at day 14 . The decreases in both urinary and plasma MHPG levels showed significant correlations with behavioral improvement during the second week . These data corroborate previous findings on sympathomimetic effects of tricyclic antidepressants in children and support a noradrenergic mechanism in the mediation of drug effects on attention deficit disorder/hyperactivity",
"A double-blind outpatient study is reported comparing imipramine hydrochloride , methylpheni date hydrochloride , and placebo treatments of 76 hyperactive grade -school boys . In addition , the predrug behavioral evaluation is examined in detail to provide guidelines for clinics examining these children . Base line clinic evaluations showed the usefulness of the psychologist 's global estimates of attention and behavior disorder , as these ratings predicted teacher rating of classroom behavior better than did psychiatric playroom observations . Parent four-day diaries of activity and family interaction also predicted teacher ratings and reflected response to stimulant medication . Although the global judgments of psychiatrists , psychologist , and the pediatrician indicated the superiority of both drugs to a placebo , all measures favored the stimulant drug . The significance of these findings may be limited , however , by the dose of imipramine hydrochloride ( 80 mg ) that was lower than in use elsewhere",
"OBJECTIVE In the Multimodal Treatment Study of ADHD ( MTA ) , the effects of medication management ( MedMgt ) and behavior modification therapy ( Beh ) and their combination ( Comb ) and usual community comparison ( CC ) in the treatment of attention-deficit/hyperactivity disorder ( ADHD ) differed at the 14-month assessment as a result of superiority of the MTA MedMgt strategy ( Comb or MedMgt ) over Beh and CC and modest additional benefits of Comb over MedMgt alone . Here we evaluate the persistence of these beneficial effects 10 months beyond the 14 months of intensive intervention . METHODS Of 579 children who entered the study , 540 ( 93 % ) participated in the first follow-up 10 months after the end of treatment . Mixed-effects regression models explored possible persisting effects of the MTA medication strategy , the incremental benefits of Comb over MedMgt alone , and the possible superiority of Beh over CC on 5 effectiveness and 4 service use domains . RESULTS The MTA medication strategy showed persisting significant superiority over Beh and CC for ADHD and oppositional-defiant symptoms at 24 months , although not as great as at 14 months . Significant additional benefits of Comb over MedMgt and of Beh over CC were not found . The groups differed significantly in mean dose ( methylpheni date equivalents 30.4 , 37.5 , 25.7 , and 24.0 mg/day , respectively ) . Continuing medication use partly mediated the persisting superiority of Comb and MedMgt . CONCLUSION The benefits of intensive MedMgt for ADHD extend 10 months beyond the intensive treatment phase only in symptom domains and diminish over time",
"The effects of the tricyclic antidepressant imipramine were evaluated in a study of 9 children with Attention Deficit-Hyperactivity Disorder . The study was double-blind , placebo-controlled , with three drug conditions , low , medium , and high doses . The focus was on neuropsychological drug effects . Imipramine exerted negative dose-response effects on motor performance ( motor speed , motor pursuit ) , while it improved hyperactive behavior and attention and raised the heart rate slightly",
"OBJECTIVE To investigate side effects of methylpheni date and desipramine alone and in combination in hospitalized children with symptoms of attention-deficit hyperactivity disorder and depression . METHOD A double-blind placebo controlled crossover design was used to investigate each medication alone and in combination . Side effect ratings and EKGs were done weekly . Pulse and blood pressure were monitored daily . RESULTS Nausea , dry mouth , and tremor were present in at least twice as many children on combined methylpheni date and desipramine compared with any other condition . Nausea/vomiting , headaches , other aches , refusal of food , and feeling \" tired \" were significantly more frequent during the combined methylpheni date plus desipramine condition when compared with either methylpheni date alone or with baseline . Significantly higher ventricular heart rate was found on combined methylpheni date plus desipramine compared with desipramine alone , methylpheni date alone , and baseline . Prolonged PR interval and significantly higher heart rate occurred during desipramine alone compared with baseline . CONCLUSIONS During the several-month duration of the study , there were more frequent side effects during combined methylpheni date plus desipramine treatment than with either medication alone . Clinical ly , side effects present during combined medication appeared to be similar to and no more serious than those associated with desipramine alone",
"OBJECTIVE To describe the rationale , methodology , and sample characteristics of a dual-site treatment study ( New York and Montreal ) of children with attention-deficit/hyperactivity disorder ( ADHD ) conducted between 1990 and 1995 . The hypotheses were that ( 1 ) methylpheni date combined with comprehensive multimodal psychosocial treatment was superior to methylpheni date alone in improving multiple functions and ( 2 ) the efficacy of the psychosocial intervention result ed from its specific components and not from nonspecific treatment effects . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to methylpheni date , were r and omized for 2 years to ( 1 ) methylpheni date treatment alone ; ( 2 ) methylpheni date combined with multimodal psychosocial treatment that included parent training and counseling , academic assistance , psychotherapy , and social skills training ; or ( 3 ) methylpheni date plus attention control treatment that excluded specific aspects of the psychosocial intervention . Children were switched to single-blind placebo after 12 months ; methylpheni date was reinstituted when clinical ly indicated . Assessment s included ratings by parents , teachers , children , and psychiatrists ; school observations in academic and gym classes ; and academic performance tests . Almost 80 % of families completed the 2-year study . Companion papers present treatment effects . CONCLUSIONS A comprehensive 2-year psychosocial treatment was delivered successfully to children with ADHD and their families",
"The tricyclic antidepressant drug desipramine ( DMI ) was evaluated in the treatment of young patients with attention deficit disorder with hyperactivity ( ADDH ) in an unselected sample of 62 clinical ly referred patients , 43 ( 69 % ) of whom previously responded poorly to psychostimulant treatment . The 42 children and 20 adolescents were assigned r and omly to receive DMI ( N = 31 ) or placebo ( N = 31 ) for up to 6 weeks in a parallel groups , double-blind study . Clinical ly and statistically significant differences in behavioral improvement were found for DMI over placebo , at an average ( + /- SEM ) maximal daily dose of 4.6 + /- 0.2 mg/kg ; 68 % of DMI-treated patients were considered very much or much improved , compared with only 10 % of placebo patients ( p less than 0.001 ) . DMI was well tolerated , even at the relatively high doses used . These findings suggest that DMI can be an effective treatment in the management of pediatric patients with ADDH , including patients who failed to respond to stimulants",
"BACKGROUND Currently , there is no consensus on the best therapeutic approach to chronic tic disorders and comorbid attention-deficit/hyperactivity disorder ( ADHD ) . To address this issue , we evaluated the tolerability and efficacy of the noradrenergic tricyclic antidepressant desipramine hydrochloride in the treatment of children and adolescents with chronic tic disorders and comorbid ADHD . METHODS Forty-one children and adolescents with chronic tic disorders , including Tourette disorder and comorbid ADHD , were studied in a 6-week , double-blind , placebo-controlled , parallel trial . Desipramine was titrated weekly up to 3.5 mg/kg per day . We rated ADHD and tic symptoms weekly and monitored adverse effects , laboratory findings , and cardiovascular parameters . RESULTS Treatment with desipramine ( mean total daily dose , 3.4 mg/kg per day ) was well tolerated without meaningful adverse effects . Desipramine significantly reduced core symptoms of ADHD ( ADHD Rating Scale ; 42 % decrease from baseline relative to placebo , P inattentive symptoms and hyperactive/impulsive symptoms ( P ADHD response rate was robust ( 71 % vs 0 % ; desipramine vs placebo , P tic symptoms ( Yale Global Tic Severity Scale ; 30 % decrease from baseline relative to placebo , P motor and phonic tic symptoms ( P tic response rate was substantial ( 58 % vs 5 % ; desipramine vs placebo , P heart rate and blood pressure . CONCLUSIONS Treatment with desipramine was well tolerated and was associated with robust clinical ly significant reductions in tic and ADHD symptoms in children and adolescents with chronic tic disorders and ADHD diagnoses",
"OBJECTIVES Because psychostimulants can exacerbate preexisting motor/phonic tics in individuals with Tourette 's syndrome ( TS ) , a clinical trial was performed to examine the ability of clonidine and desipramine to modify attention-deficit hyperactivity disorder ( ADHD ) behaviors in children with TS + ADHD . METHODS A double-blind , placebo-controlled protocol was used in which each subject served as his or her own control and received , in a r and omly assigned fashion , 6-week medication cycles with clonidine ( 0.05 mg four times daily ) , desipramine ( 25 mg four times daily ) , and placebo . RESULTS Thirty-seven children with TS+ADHD between the ages 7 to 13 years and of normal intellect were recruited , and 34 ( 31 males , 3 females ) completed the entire protocol . Outcome measures for ADHD included Parent and Teacher Child Behavior Checklists ( CBCL ) , continuous performance tests , and neuropsychologic tests of executive function . Several markers for ADHD were shown to improve significantly ( P desipramine ( parent linear analogue rating , parent CBCL \" hyperactivity \" subscale , and teacher CBCL subscales \" nervous/overactive , \" \" anxious , \" and \" unpopular \" ) . Improvement with desipramine was always superior to that noted with clonidine . Clinical improvement did not correlate with drug blood levels . On measures of tic severity , neither drug made tics worse . Desipramine showed a statistically significant improvement on a global linear analogue scale , but not on the Hopkins Motor/Vocal Tic Severity Scale , the Tourette Syndrome Severity Scale , or the Yale Global Tic Severity Scale . Clonidine did not significantly alter tic severity on any measure . CONCLUSION The results of this study suggest that desipramine may be a useful alternative for the treatment of symptoms of ADHD in children with TS",
"OBJECTIVE To evaluate the prevalence , comorbid conditions , and impairments of attention-deficit/hyperactivity disorder ( ADHD ) among young adolescents in Porto Alegre , Brazil . METHOD 1,013 students aged 12 to 14 years were evaluated at 64 state schools , using a screening instrument based on the 18 DSM-IV ADHD symptoms . All positive screened students ( n = 99 ) and a r and om subset of negative screened subjects ( n = 92 ) had a psychiatric evaluation carried out within a hospital setting or at home . RESULTS The prevalence of ADHD was estimated to be 5.8 % ( 95 % confidence interval = 3.2 - 10.6 ) , and the comorbidity with other disruptive behavior disorders was high ( 47.8 % ) . Youths with ADHD ( n = 23 ) had significantly higher rates of school repetitions , suspensions , and expulsions ( p < .01 ) than controls ( n = 168 ) . No association was identified between ADHD and alcohol , marijuana , and inhalant use . CONCLUSION The results extend to adolescents well-documented findings in children , indicating that ADHD is quite prevalent in early adolescence and affected youths are at high risk for impairment and dysfunction in multiple domains"
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41180cc0-06ff-11f0-808a-c43d1ab1c353
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INTRODUCTION Pentoxifylline is a xanthine derivative with potential cardiovascular benefits . AIM To evaluate the impact of pentoxifylline on blood pressure ( BP ) and plasma TNF-α , C-reactive protein ( CRP ) and IL-6 through a systematic review and meta- analysis of r and omized controlled trials . METHODS The protocol was registered ( PROSPERO : CRD42016035988 ) . The search included PUBMED , ProQuest , Scopus and EMBASE until 1 September 2015 to identify trials reporting BP or inflammatory markers during pentoxifylline therapy . Quantitative data synthesis was performed using a r and om-effects model , with weighted mean difference ( WDF ) and 95 % confidence intervals ( CIs ) as summary statistics . RESULTS Fifteen studies ( 16 treatment arms ) were found to be eligible for inclusion . Meta- analysis did not suggest any effect of pentoxifylline on either SBP or DBP . Pentoxifylline treatment was associated with a significant reduction in plasma concentrations of TNF-α ( WDF : -1.03 pg/ml , 95 % CI : -1.54 , -0.51 ; P and CRP ( WDF : -1.39 mg/l , 95 % CI : -2.68 , -0.10 ; P = 0.034 , five treatment arms ) . No alteration in plasma IL-6 concentration was observed . The impact of pentoxifylline on plasma TNF-α levels was found to be positively associated with treatment duration ( slope : 0.031 ; 95 % CI : 0.004 , 0.057 ; P = 0.023 ) but independent of pentoxifylline dose ( slope : -0.0003 ; 95 % CI : -0.002 , 0.001 ; P = 0.687 ) . CONCLUSION Pentoxifylline did not alter BP or plasma IL-6 concentration , but significantly reduced circulating TNF-α and CRP concentrations
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"Background —We previously reported beneficial effects of pentoxifylline , a xanthine-derived agent known to inhibit the production of tumor necrosis factor-&agr ; , in patients with idiopathic dilated cardiomyopathy treated with diuretics , digoxin , and ACE inhibitors . Since then , 3 large clinical trials showed important clinical benefits of & bgr;-blockers in this population . Therefore , we design ed the present study to establish whether in patients with heart failure already receiving treatment with ACE inhibitors and & bgr;-blockers , the addition of pentoxifylline would have an additive beneficial effect . Methods and Results —In a single-center , prospect i ve , double-blind , r and omized , placebo-controlled study , 39 patients with idiopathic dilated cardiomyopathy were r and omized to pentoxifylline 400 mg TID ( n=20 ) or placebo ( n=19 ) if they had a left ventricular ejection fraction with digoxin , ACE inhibitors , and carvedilol . Primary end points were New York Heart Association functional class , exercise tolerance , and left ventricular function . Patients were followed up for 6 months . Five patients died ( 3 in the placebo group ) . Patients treated with pentoxifylline had a significant improvement in functional class compared with the placebo group ( P = 0.01 ) , with an increment in exercise time from 9.5±5 to 12.3±6 minutes ( P = 0.1 ) . Left ventricular ejection fraction improved from 24±9 % to 31±13 % , P = 0.03 , in the treatment group . Conclusions —In patients with idiopathic dilated cardiomyopathy , the addition of pentoxifylline to treatment with digoxin , ACE inhibitors , and carvedilol is associated with a significant improvement in symptoms and left ventricular function",
"BACKGROUND Since inflammation is believed to have a role in the pathogenesis of cardiovascular events , measurement of markers of inflammation has been proposed as a method to improve the prediction of the risk of these events . METHODS We conducted a prospect i ve , nested case-control study among 28,263 apparently healthy postmenopausal women over a mean follow-up period of three years to assess the risk of cardiovascular events associated with base-line levels of markers of inflammation . The markers included high-sensitivity C-reactive protein ( hs-CRP ) , serum amyloid A , interleukin-6 , and soluble intercellular adhesion molecule type 1 ( sICAM-1 ) . We also studied homocysteine and a variety of lipid and lipoprotein measurements . Cardiovascular events were defined as death from coronary heart disease , nonfatal myocardial infa rct ion or stroke , or the need for coronary-revascularization procedures . RESULTS Of the 12 markers measured , hs-CRP was the strongest univariate predictor of the risk of cardiovascular events ; the relative risk of events for women in the highest as compared with the lowest quartile for this marker was 4.4 ( 95 percent confidence interval , 2.2 to 8.9 ) . Other markers significantly associated with the risk of cardiovascular events were serum amyloid A ( relative risk for the highest as compared with the lowest quartile , 3.0 ) , sICAM-1 ( 2.6 ) , interleukin-6 ( 2.2 ) , homocysteine ( 2.0 ) , total cholesterol ( 2.4 ) , LDL cholesterol ( 2.4 ) , apolipoprotein B-100 ( 3.4 ) , HDL cholesterol ( 0.3 ) , and the ratio of total cholesterol to HDL cholesterol ( 3.4 ) . Prediction models that incorporated markers of inflammation in addition to lipids were significantly better at predicting risk than models based on lipid levels alone ( P levels of hs-CRP and serum amyloid A were significant predictors of risk even in the subgroup of women with LDL cholesterol levels below 130 mg per deciliter ( 3.4 mmol per liter ) , the target for primary prevention established by the National Cholesterol Education Program . In multivariate analyses , the only plasma markers that independently predicted risk were hs-CRP ( relative risk for the highest as compared with the lowest quartile , 1.5 ; 95 percent confidence interval , 1.1 to 2.1 ) and the ratio of total cholesterol to HDL cholesterol ( relative risk , 1.4 ; 95 percent confidence interval , 1.1 to 1.9 ) . CONCLUSIONS The addition of the measurement of C-reactive protein to screening based on lipid levels may provide an improved method of identifying persons at risk for cardiovascular events",
"Despite the beneficial effects of blockade of the renin-angiotensin system in diabetic nephropathy ( DN ) , albuminuria and progression of renal disease are not completely halted by these agents . Therefore , it is necessary to explore potential antiproteinuric and renoprotective effects of innovative therapeutic approaches . This study tested the hypothesis that the combination of pentoxifylline ( PTF ) with angiotensin II receptor blockers in normotensive patients with type 2 diabetes produces an additive antiproteinuric effect . Sixty-one patients with DN and residual albuminuria despite treatment with the recommended doses of ARB for > 1 yr were r and omly assigned to receive the addition of 1200 mg of PTF daily ( n = 30 ) or to a control group ( n = 31 ) . Baseline characteristics were similar between groups , and correlation analysis showed a significant association between urinary albumin excretion ( UAE ) and urinary TNF-alpha ( R = 0.53 , P mo , albuminuria showed a significant decrease in patients who received PTF , from 900 mg/24 h ( 466 to 1542 mg/d ) to 791 mg/24 h ( 309 to 1400 mg/d ; P mean percentage variation of UAE in the treatment and control groups was -16.7 and 5.5 % , respectively ( between-group comparison , P additive antiproteinuric effect was not dependent on changes in BP or metabolic control . However , both serum and urinary levels of TNF-alpha also decreased in patients who received PTF , from 6.4 pg/ml ( 2.1 to 9.7 ) and 16 pg/mg ( 8 to 29 ) at baseline to 4.6 pg/ml ( 0.4 to 9 ) and 14.2 pg/mg ( 3 to 26 ) at the end of the study , respectively ( P change in UAE and the change in urinary TNF-alpha in patients who were treated with PTF ( R = 0.49 , P have type 2 diabetes and are under long-term treatment with an ARB produces a significant additive antiproteinuric effect associated with a reduction of urinary TNF-alpha excretion",
"Background —Inflammatory immune activation commonly occurs in heart failure and may perpetuate this syndrome . We sought to determine whether the immunomodulating agent pentoxifylline enhances left ventricular function in patients with ischemic cardiomyopathy . We also investigated the effect of therapy on levels of brain natriuretic peptide ( NT-pro BNP ) , C-reactive protein ( CRP ) , tumor necrosis factor-&agr ; ( TNF-&agr ; ) , and the marker of apoptosis , Fas/Apo-1 . Methods and Results —In a single-center , prospect i ve , r and omized , double-blind , placebo-controlled study , 38 patients with ischemic cardiomyopathy received pentoxifylline 400 mg TID or placebo in addition to st and ard therapy . Clinical assessment , radionuclide ventriculography , echocardiography , and blood analyses were performed at baseline and after 6 months . There were no differences in baseline characteristics between the groups . Five patients died ( 4 in the placebo group ) . Pentoxifylline treatment result ed in an improvement in functional class ( P systolic blood pressure ( P left ventricular radionuclide ejection fraction ( P plasma concentrations of CRP , NT-pro BNP , TNF-&agr ; , and Fas/Apo-1 in the pentoxifylline compared with the placebo-treated group . Conclusions —In patients with heart failure due to ischemic left ventricular dysfunction , the addition of pentoxifylline to st and ard therapy results in improvements in clinical status and radionuclide ejection fraction , which are accompanied by reductions in plasma markers of inflammation , prognosis , and apoptosis",
"Background Untreated HIV may increase the risk of cardiovascular events . Our preliminary in vitro and in vivo research suggests that pentoxifylline ( PTX ) reduces vascular inflammation and improves endothelial function in HIV-infected persons not requiring antiretroviral therapy . Methods We performed a r and omized , placebo-controlled trial of PTX 400 mg orally thrice daily for 8 weeks in 26 participants . The primary endpoint was change in flow-mediated dilation ( FMD ) of the brachial artery after 8 weeks . Nitroglycerin-mediated dilation ( NTGMD ) and circulating markers of inflammation , cellular immune activation , coagulation , and metabolism were also assessed . Results The difference in mean absolute change ( SD ) in FMD after 8 weeks between the placebo [ −1.06 (1.45)% ] and PTX [ −1.93 (3.03)% ] groups was not significant ( P = 0.44 ) . No differences in NTGMD were observed . The only significant between-group difference in the changes in biomarkers from baseline to week 8 was in soluble tumor necrosis factor receptor-1 ( sTNFRI ) [ −83.2 pg/mL in the placebo group vs. + 65.9 pg/mL in the PTX group ; P = 0.03 ] . PTX was generally well-tolerated . Conclusions PTX did not improve endothelial function and unexpectedly increased the inflammatory biomarker sTNFRI in HIV-infected participants not requiring antiretroviral therapy . Additional interventional research is needed to reduce inflammation and cardiovascular risk in this population . Trial Registration Clinical Trials.gov",
"Although blockade of renin-angiotensin system have been cited as the first line of therapy for the management of diabetic nephropathy ( DN ) , however in a substantial number of patients , progression of renal disease are not completely halted by these agents . We have conducted a double blinded clinical trial to assess the additive effect of pentoxifylline on reduction of proteinuria among patients with type 2 DM under blockade of angiotensin system . The dosage of PTX used in our trial was at a low dosage of 400 mg daily and to our knowledge , we did not found article which evaluated the antiproteinuric effect of pentoxifylline in this dosage . One hundred patients with DN and persistent proteinuria despite treatment with losartan and enalapril in at least 3 months before inclusion in the study were r and omly assigned to two groups . Control group ( n=50 , 26 males and 24 females ) received losartan and enalapril , while treatment group ( PTX Group ) ( n=50 , 28 males and 22 females ) was given losartan , enalapril and pentoxifylline 400mg/day for 6 months . At the beginning of the study there were no significant differences in demographic and clinical characteristics of patients including serum creatinine , HbA1c , blood pressure and urinary protein excretion between two groups ( P>.05 ) . In the PTX group , the mean rate of urinary protein excretion have significantly decreased from 616.66 mg to 378.24 after 3 months ( P=.000 ) and to 192.05 mg after 6 months ( P=.000 ) whereas no significant changes were observed in the control group . The beneficial antiproteinuric effect of PTX was not associated to the degree of metabolic control and a reduction of blood pressure . In addition , at the end of study , the mean clearance of creatinine was significantly higher in PTX group ( P=.04 ) . In conclusion , PTX can significantly provide additive antiproteinuric effect and slow the decrease in GFR among patients with type 2 DM under blockade of angiotensin system",
"INTRODUCTION The burden of non-alcoholic steatohepatitis ( NASH ) is growing and current pharmacologic treatments are limited by side effects and inconsistent efficacy . Pilot studies suggest that pentoxifylline ( PTX ) can reduce liver injury in patients with NASH . OBJECTIVE We sought to determine the tolerability of PTX and its effect on aminotransferases and liver histology in patients with NASH . MATERIAL AND METHODS Thirty patients with biopsy proven NASH were r and omized in a 2:1 fashion to receive 1,200 mg PTX or placebo for 12 months . Metabolic parameters , aminotransferases , liver histology and hepatic gene expression changes were compared . RESULTS At baseline the groups were similar . Adverse events were mild , most frequently headache and abdominal cramps , and did not differ between groups ( p = NS ) . After 12 months , ALT and AST decreased from 92 ± 12 IU/L to 67 ± 13 IU/L and 67 ± 6 IU/L to 47 ± 6 IU/L ( p with PTX . No significant effect was seen with placebo . Steatosis and cellular ballooning improved in the PTX group ( p no histological feature of steatohepatitis improved with placebo . However , between groups comparison of both biochemical and histological features were nonsignificant . CONCLUSION Pentoxifylline is safe , well tolerated and improves transaminases and histology in patients with NASH when compared to baseline and may be a reasonable therapeutic modality for the treatment of NASH . However PTX failed to reduce transaminases compared to placebo and did not positively affect any of the metabolic markers postulated to contribute to NASH . Although animal data and small pilot studies in humans have suggested that PTX may be effective as a treatment for NASH , translating this therapy to clinical practice may prove challenging",
"Background . Pentoxifylline is a nonspecific phosphodiesterase inhibitor with anti-inflammatory properties . Human studies have proved its antiproteinuric effect in patients with glomerular diseases , but this study was design ed to assess the effects of add-on pentoxifylline to available treatment on reduction of microalbuminuria in diabetic patients without glomerular diseases . Methods . In a double-blind placebo-controlled , r and omized study we evaluated the influence of pentoxifylline on microalbuminuria in type 2 diabetic patients . 40 diabetic patients with estimated glomerular filtration rate ( eGFR ) of more than 60 mL/min/1.73 m2 in eight weeks and microalbuminuria were r and omized to two groups which will receive pentoxifylline 1200 mg/day or placebo added to regular medications for 6 months . albuminuria ; eGFR was evaluated at three- and six-month follow-up period . Results . Baseline characteristics were similar between the two groups . At six months , the mean estimated GFR and albuminuria were not different between two groups at 3- and 6-month follow-up . Trend of albumin to creatinine ratio , systolic and diastolic blood pressure , and eGFR in both groups were decreased , but no significant differences were noted between two groups ( P value > 0.05 ) . Conclusion . Pentoxifylline has not a significant additive antimicroalbuminuric effect compared with placebo in patients with type 2 diabetes with early stage of kidney disease ; however , further clinical investigations are necessary to be done",
"Abstract Background Non-alcoholic fatty liver disease is a common health problem associated with increased liver and vascular specific complications . Aim The purpose of this study was to assess and compare the effect of fenofibrate alone or in combination with pentoxifylline on the measured biochemical parameters , inflammatory pathway and liver stiffness in patients with non-alcoholic fatty liver disease . Methods The study design was r and omized controlled trial . From July 2013 to June 2014 , we recruited 90 non-alcoholic fatty liver patients from the Internal Medicine Department at Tanta University Hospital , Egypt . They were classified r and omly into two groups to receive fenofibrate 300 mg daily or fenofibrate 300 mg daily plus pentoxifylline 1200 mg/day in three divided doses for 24 weeks . Fasting blood sample was obtained before and 24 weeks after treatment for biochemical analysis of liver and lipid panels , tumor necrosis factor-alpha , hyaluronic acid , transforming growth factor beta 1 , fasting plasma insulin and fasting glucose . Liver stiffness measurement was carried out using fibro-scan . Data were statistically analyzed by paired and unpaired Student ’s t test . Results The data obtained suggests that adding pentoxifylline to fenofibrate does not provide a beneficial effect on lipid panel , but has a beneficial effect on indirect biochemical markers of hepatic fibrosis , a direct marker linked to matrix deposition ( hyaluronic acid ) , a cytokine/growth factor linked to liver fibrosis ( transforming growth factor beta 1 ) , the inflammatory pathway , insulin resistance and liver stiffness as compared to fenofibrate alone . Conclusion The combination pentoxifylline plus fenofibrate may represent a new therapeutic strategy for non-alcoholic fatty liver disease as it result ed in more beneficial effects on direct and indirect markers of liver fibrosis , liver stiffness , insulin resistance and inflammatory pathway implicated in NAFLD",
"BACKGROUND There is accumulating evidence that inflammatory cytokines have an important role in the pathogenesis of heart failure . Plasma concentrations of tumour necrosis factor alpha ( TNF-alpha ) are high in heart failure and have been correlated with the severity of symptoms . Pentoxifylline suppresses the production of TNF-alpha . This study aim ed to assess the effects of pentoxifylline on left-ventricular function and functional class in patients with idiopathic dilated cardiomyopathy . METHODS We undertook a single-centre , prospect i ve , double-blind , r and omised , placebo-controlled trial , in which 28 patients with idiopathic dilated cardiomyopathy were assigned pentoxifylline 400 mg three times daily or matching placebo . Clinical , echocardiographic , and radionuclide assessment s were done at baseline and after 6 months of treatment . Primary endpoints were New York Heart Association ( NYHA ) functional class and left-ventricular function . FINDINGS Baseline characteristics were similar in the two groups . Four patients died during the study period , all in the placebo group . After 6 months of treatment , the proportion of patients in NYHA functional class I or II was higher in the pentoxifylline group than in the placebo group ( 14/14 vs 10/14 ; p=0.01 ) , and ejection fraction was higher in the pentoxifylline group than in the placebo group ( mean 38.7 % [ SD 15.0 ] vs 26.8 % [ 11.0 ] , p=0.04 ) . At 6 months , TNF-alpha plasma concentrations were significantly lower in the pentoxifylline-treated group than in the placebo group ( 2.1 [ 1.0 ] vs 6.5 [ 5.0 ] pg/mL , p=0.001 ) . INTERPRETATION Our results suggest that pentoxifylline improves symptoms and left-ventricular systolic function in patients with idiopathic dilated cardiomyopathy . These results must be confirmed in larger-scale trials",
"INTRODUCTION Tumor necrosis factor (TNF)-alpha and interleukin-6 ( IL-6 ) are significantly elevated in patients with congestive heart failure ( CHF ) . Pentoxifylline , a xanthin-derived agent , is known to inhibit the production of TNF-alpha and IL-6 . Recent studies have shown that pentoxifylline produces an increase in ejection fraction , a decrease in left-ventricular chamber size and an improvement in clinical status in patients with idiopathic-dilated cardiomyopathy . Therefore , we studied the effects of pentoxifylline in ischemic , hypertensive and idiopathic-dilated cardiomyopathy . METHODS Primary endpoint was left-ventricular ejection fraction ( LVEF ) assessed by contrast 2D echocardiography . Secondary endpoints were concentrations of TNF-alpha , IL-6 , brain natriuretic peptide , maximal oxygen uptake ( VO(2 max ) ) assessed by cardiopulmonary exercise testing and Minnesota Living with Heart Failure Question naire score or New York Heart Association scale . RESULTS Forty-seven patients ( 31.9 % ischemic , 21.3 % hypertensive , 10.6 % ischemic and hypertensive , 36.2 % idiopathic-dilated cardiomyopathy ) were r and omly assigned to pentoxifylline 600 mg BID ( n=23 ) or placebo ( n=24 ) if they had a compensated CHF with a LVEF less than or equal to 40 % and had taken their st and ard treatment consisting of angiotensin-converting enzyme inhibitors , diuretics and beta-blockers for at least 3 months . Baseline demographic and clinical characteristics of each group were similar . Forty-one patients completed the study protocol and were analysed for primary and secondary endpoints . After 6 months of treatment , LVEF was unchanged in the pentoxifylline group compared with placebo ( 29+/-7 to 33+/-10 % vs. 27+/-9 to 34+/-9 % , respectively , P = NS ) . Also the secondary endpoints did not significantly change during follow-up . CONCLUSION Additional treatment with pentoxifylline is neutral with regard to left-ventricular function , inflammatory cytokines and symptoms in patients with ischemic , hypertensive and idiopathic-dilated cardiomyopathy",
"UNLABELLED The primary aim of this study was to compare the effects of pentoxifylline ( PTX ) versus placebo on the histological features of nonalcoholic steatohepatitis ( NASH ) . In all , 55 adults with biopsy-confirmed NASH were r and omized to receive PTX at a dose of 400 mg three times a day ( n = 26 ) or placebo ( n = 29 ) over 1 year . The primary efficacy endpoint was defined as improvement in histological features of NASH through reduction in steatosis , lobular inflammation , and /or hepatocellular ballooning as reflected by a decrease of ≥ 2 points in the nonalcoholic fatty liver disease ( NAFLD ) activity score ( NAS ) . After 1 year , intention-to-treat analysis showed a decrease of ≥ 2 points in the NAS in 38.5 % of patients on PTX versus 13.8 % of those on placebo ( P = 0.036 ) . Per protocol analysis , a decrease of ≥ 2 points in the NAS from baseline was observed in 50 % of the patients on PTX versus 15.4 % of those on placebo ( P = 0.01 ) . The mean change in NAS score from baseline was -1.6 in the PTX group , versus -0.1 in the placebo group ( P PTX significantly improved steatosis ( mean change in score -0.9 versus -0.04 with placebo , P ) and lobular inflammation ( median change -1 versus 0 with placebo , P = 0.02 ) . No significant effects in hepatocellular ballooning were observed . PTX also improved liver fibrosis ( mean change in fibrosis score was -0.2 among those on PTX versus + 0.4 among those on placebo , P = 0.038 ) . Although not statistically significant ( P = 0.17 ) , improvement in fibrosis was observed in a greater proportion ( 35 % ) of patients in the PTX group compared to placebo ( 15 % ) . Adverse effects were similar in both groups . CONCLUSION PTX improved histological features of NASH compared to placebo . PTX was well tolerated in patients with NASH",
"The balance between different immunological stimuli is essential in the progression and stabilization of atherosclerotic plaques . Immune regulation has been suggested as potential target for the treatment of atherosclerotic disease . We sought to determine whether treatment with pentoxifylline , a phosphodiesterase inhibitor with immunomodulating properties , could reduce the pro-inflammatory response observed in patients with acute coronary syndromes ( ACS ) and increase anti-inflammatory activity . In a double-blind , prospect i ve , placebo-controlled study , 64 patients with ACS were r and omized to receive pentoxifylline 400 mg TID or placebo for 6 months . Analysis of the pro-inflammatory markers , C-reactive protein ( CRP ) , interleukin (IL)-6 , IL-12 , interferon-gamma and tumor necrosis factor (TNF)-alpha and the anti-inflammatory cytokines , transforming growth factor (TGF)-beta1 and IL-10 were done at baseline , 1 and 6 months . Pentoxifylline treatment significantly reduced the adjusted levels of CRP and TNF-alpha compared to placebo after 6 months ( P=0.04 and P IL-12 increase was significantly less pronounced with pentoxifylline ( P=0.04 ) . The levels of the anti-inflammatory cytokine , IL-10 , also declined significantly less in the pentoxifylline group compared to placebo ( P Pentoxifylline reduces pro-inflammatory and increases anti-inflammatory response in patients with ACS and may have beneficial clinical effects on cardiovascular events",
"Oxpentifylline ( pentoxifylline ) , which is known to have pharmacological effects in animal models of respiratory distress syndrome , multiorgan failure , and shock , was tested in human beings after injection of endotoxin . Of ten healthy volunteers , nine met the inclusion criterion of a rise in body temperature of at least 1.0 degrees C after 100 ng endotoxin ( Salmonella abortus equi ) as a bolus injection . Serum levels of tumour necrosis factor alpha ( TNF ) and interleukin-6 ( IL-6 ) were both significantly higher than baseline levels 2 h and 3 h after endotoxin injection . 3 weeks later the nine volunteers were again injected with 100 ng endotoxin and oxpentifylline ( 500 mg over 4 h ) was also infused . There was no rise in TNF levels , though IL-6 levels rose in parallel with body temperature . These data suggest that oxpentifylline blocks the endotoxin-induced synthesis of TNF in man and , therefore , could possibly have beneficial effects in clinical endotoxaemia",
"OBJECTIVES Inflammation and oxidative stress are main culprits behind atherosclerosis in diabetes mellitus . This study explores the effect of add-on Pentoxifylline on inflammatory burden and oxidative stress in hypertensive diabetic patients . RESEARCH DESIGN AND METHODS 60 hypertensive type 2 diabetic , aged > or = 45 years were evaluated for anthropometry , clinical parameters , C-reactive protein , total leukocyte count , erythrocyte sedimentation rate , serum albumin , plasma malondialdehyde , blood reduced glutathione , platelet aggregation and clot retraction profile . With informed consent and r and omization , Pentoxifylline ( 400 mg ) was prescribed to 30 patients orally twice daily with meals as add-on therapy to the st and ard therapeutic regimen for one month . The particular parameters were repeated in 26 patients in control group and 25 patients in Pentoxifylline group who completed the follow up . The study was a r and omized , open , add-on clinical trial with parallel controls . RESULTS At one-month follow-up , in the Pentoxifylline group , there was 20.9 % decrease ( p C-reactive protein , 18 % reduction ( p erythrocyte sedimentation rate , 11.1 % reduction ( p total leukocyte count and 5.8 % increase ( p=0.003 ) in serum albumin . Pentoxifylline showed 20.2 % reduction in plasma malondialdehyde and 4.6 % increase in blood reduced glutathione level . In therapeutic dose range , Pentoxifylline exerted a significant anti-aggregatory effect and a dose dependent decrease in clot retraction in-vitro but there was no significant change in ex-vivo clot retraction . The control group showed no statistically significant change in parameters assessed . CONCLUSION This study reveals improvements in inflammatory markers , oxidative stress and platelet-aggregation by Pentoxifylline , thus preventing atherosclerosis in diabetes mellitus",
"Pentoxifylline ( PTX ) is a nonselective phosphodiesterase inhibitor that inhibits the production of TNFalpha and IL6 and IL-10 cytokines . In renal rejection TNFalpha , IL-6 , and IL-10 may have important roles . In this study , 22 renal transplant recipients treated with tacrolimus , prednisolone , and mycophenolate mofetil were prescribed PTX ( 2 x 600 mg/d ) for 3 months ( GI ) , and 20 similar patients not receiving PTX were used as controls ( GII ) . Stable subjects whose serum creatinine was lower than 1.8 mg/dL and were more than 6 months posttransplant , were enrolled into this study if the blood pressure was well controlled and there was no diabetes mellitus , infection , or inflammation . At the end of 3 months TNF-alpha decreased from 4.2 + /- 2.1 to 2.4 + /- 0.7 ( P = .001 ) and 4.0 + /- 2.2 to 3.9 + /- 1.7 ( P = .718 ) , IL-10 also decreased from 3.90 + /- 1.9 to 2.38 + /- 0.6 ( P = .001 ) and 4.02 + /- 1.6 to 3.82 + /- 1.5 ( P = .225 ) in GI and GII , respectively . For IL-10 and TNF-alpha the alterations between baseline and the last visit of GI and GII were significant ( P Resistive index ( RI ) decreased in GI but the difference in alterations between baseline and the last visit of GI and GII was marginal . In summary IL-10 and TNF-alpha levels decreased in stable recipients treated with PTx . RI also decreased marginally secondary to PTx treatment . PTx was well tolerated and free side effects . PTx did not affect tacrolimus levels or other biochemical and hematological parameters",
"Diabetic kidney disease ( DKD ) is the leading cause of ESRD . We conducted an open-label , prospect i ve , r and omized trial to determine whether pentoxifylline ( PTF ) , which reduces albuminuria , in addition to renin-angiotensin system ( RAS ) blockade , can slow progression of renal disease in patients with type 2 diabetes and stages 3 - 4 CKD . Participants were assigned to receive PTF ( 1200 mg/d ) ( n=82 ) or to a control group ( n=87 ) for 2 years . All patients received similar doses of RAS inhibitors . At study end , eGFR had decreased by a mean±SEM of 2.1±0.4 ml/min per 1.73 m(2 ) in the PTF group compared with 6.5±0.4 ml/min per 1.73 m(2 ) in the control group , with a between-group difference of 4.3 ml/min per 1.73 m(2 ) ( 95 % confidence interval [ 95 % CI ] , 3.1 to 5.5 ml/min per 1.73 m(2 ) ; P The proportion of patients with a rate of eGFR decline greater than the median rate of decline ( 0.16 ml/min per 1.73 m(2 ) per month ) was lower in the PTF group than in the control group ( 33.3 % versus 68.2 % ; P ) . Percentage change in urinary albumin excretion was 5.7 % ( 95 % CI , -0.3 % to 11.1 % ) in the control group and -14.9 % ( 95 % CI , -20.4 % to -9.4 % ) in the PTF group ( P=0.001 ) . Urine TNF-α decreased from a median 16 ng/g ( interquartile range , 11 - 20.1 ng/g ) to 14.3 ng/g ( interquartile range , 9.2 - 18.4 ng/g ) in the PTF group ( P population , addition of PTF to RAS inhibitors result ed in a smaller decrease in eGFR and a greater reduction of residual albuminuria ",
"BACKGROUND Pentoxifylline ( PTF ) is a potential therapeutic agent in chronic kidney disease due to its antiinflammatory and antiproteinuric effects that may influence the progression of renal disease . SUBJECTS AND METHODS We conducted a prospect i ve r and omized trial of 91 patients with estimated glomerular filtration rate ( eGFR ) Patients were r and omly assigned to treatment with PTF 400 mg ( twice a day ) ( n=46 ) or to continue their usual therapy ( n=45 ) . Clinical , biochemical and inflammatory parameters were measured at baseline , and at 6 and 12 months of treatment . The objective of the study was to analyze the effect of PTF treatment on inflammatory markers and secondarily the effect on renal disease progression . RESULTS Baseline characteristics were similar in the 2 groups . High-sensitivity C-reactive protein ( hs-CRP ) , serum fibrinogen and TNF-alpha decreased significantly in patients treated with PTF in comparison with the control group at 12 months ( p=0.002 , p=0.001 and p=0.000 , respectively ) . Median urinary albumin excretion did not decrease with PTF treatment . In the PTF group , there was no significant change in eGFR after 12 months ( from 42.3 ± 10.2 to 44.7 ± 11.3 ml/min per 1.73 m(2 ) ) , whereas in the control group there was a worsening by the end of the study ( from 40.1 ± 12.4 to 35.7 ± 13.4 ml/min per 1.73 m(2 ) ) ( p=0.000 between groups ) . CONCLUSIONS PTF treatment decreases inflammatory markers in chronic kidney disease and stabilizes renal function"
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Objectives Several iterations of the Sport Concussion Assessment Tool ( SCAT ) have been published over the past 16 years . Our goal was to systematic ally review the literature related to the SCAT and provide recommendations for improving the tool . To achieve this goal , five separate but related search es were conducted and presented herein . Design Systematic literature review . Data sources Medline , Embase , PsycINFO , Cumulative Index of Nursing and Allied Health Literature ( CINAHL ) , Cochrane Central Register of Controlled Trials , SPORTD iscus and PubMed . Eligibility criteria Original , empirical , peer- review ed findings published in English and included sports-related concussion ( SRC ) . Review papers , case studies , editorials and conference proceedings/ abstract s were excluded . The age range for the ChildSCAT was 5–12 years and for the Adult SCAT was 13 years and above . Results Out of 2961 articles screened , a total of 96 articles were included across the five search es . Search es were not mutually exclusive . The final number of articles included in the qualitative synthesis for each search was 21 on Adult SCAT , 32 on ChildSCAT , 21 on sideline , 8 on video/observation and 14 on oculomotor . Summary / conclusions The SCAT is the most widely accepted and deployable sport concussion assessment and screening tool currently available . There is some degree of support for using the SCAT2/SCAT3 and ChildSCAT3 in the evaluation of SRC , with and without baseline data . The addition of an oculomotor examination seems indicated , although the most valid method for assessing oculomotor function is not clear . Video-observable signs of concussion show promise , but there is insufficient evidence to warrant widespread use at this time
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"CONTEXT To determine if testing environment affects Balance Error Scoring System ( BESS ) scores in healthy collegiate baseball players . DESIGN Experimental , r and omized , repeated- measures design with a sample of convenience . SETTING Uncontrolled sideline and controlled locker room baseball environments . PATIENTS OR OTHER PARTICIPANTS A total of 21 healthy collegiate baseball players ( age = 20.1 + /- 1.4 years , height = 185.1 + /- 6.8 cm , mass = 86.3 + /- 9.5 kg ) with no history of head injury within the last 12 months , no lower extremity injuries reported within the past 2 months that caused them to miss 1 or more days of practice or game time , and no history of otitis media , Parkinson disease , or Meniere disease . MAIN OUTCOME MEASURE(S ) Participants performed the BESS test in 2 environments , controlled locker room and uncontrolled sideline , in 2 testing sessions 1 week apart during the baseball preseason . The BESS scores were evaluated for each of the 6 conditions and total score across the testing sessions . Separate , paired- sample s t tests with Bonferroni adjustment ( P Cohen d tests were calculated to evaluate effect sizes and relative change . RESULTS Significant group mean differences were found between testing environments for single-leg foam stance ( P = .001 ) , with higher scores reported for the uncontrolled sideline environment ( 7.33 + /- 2.11 errors ) compared with the controlled clinical environment ( 5.19 + /- 2.16 errors ) . Medium to large effect sizes ( 0.53 to 1.03 ) were also found for single-leg foam , t and em foam , and total BESS scores , with relative increases ( worse scores ) of 30 % to 44 % in the sideline environment compared with the clinical environment . CONCLUSIONS The BESS performance was impaired when participants were tested in a sideline environment compared with a clinical environment . Baseline testing for postural control using the BESS should be conducted in the setting or environment in which testing after injury will most likely be conducted",
"Background : Sports-related concussion commonly affects the visual pathways . Current sideline protocol s test cognition and balance but do not include assessment s of visual performance . We investigated how adding a vision-based test of rapid number naming could increase our ability to identify concussed athletes on the sideline at youth and collegiate levels . Methods : Participants in this prospect i ve study included members of a youth ice hockey and lacrosse league and collegiate athletes from New York University and Long Isl and University . Athletes underwent preseason baseline assessment s using : 1 ) the King – Devick ( K-D ) test , a , 2 ) the St and ardized Assessment of Concussion ( SAC ) , a test of cognition , and 3 ) a timed t and em gait test of balance . The SAC and timed t and em gait are components of the currently used Sport Concussion Assessment Tool , 3rd Edition ( SCAT3 and Child-SCAT3 ) . In the event of a concussion during the athletic season , injured athletes were retested on the sideline/rink-side . Nonconcussed athletes were also assessed as control participants under the same testing conditions . Results : Among 243 youth ( mean age 11 ± 3 years , range 5–17 ) and 89 collegiate athletes ( age 20 ± 1 years , range 18–23 ) , baseline time scores for the K-D test were lower ( better ) with increasing participant age ( P , K-D scores worsened from baseline by an average of 5.2 seconds ; improvement by 6.4 seconds was noted for the nonconcussed controls ( n = 14 ) . The vision-based K-D test showed the greatest capacity to distinguish concussed vs control athletes based on changes from preseason baseline to postinjury ( receiver operating characteristic [ ROC ] curve areas from logistic regression models , accounting for age = 0.92 for K-D , 0.87 for timed t and em gait , and 0.68 for SAC ; P = 0.0004 for comparison of ROC curve areas ) . Conclusions : Adding a vision-based performance measure to cognitive and balance testing enhances the detection capabilities of current sideline concussion assessment . This observation in patients with mild traumatic brain injury reflects the common involvement and widespread distribution of brain pathways dedicated to vision",
"OBJECTIVE Concussion is the most common type of traumatic brain injury , and results from impact or impulsive forces to the head , neck or face . Due to the variability and subtlety of symptoms , concussions may go unrecognized or be ignored , especially with the pressure placed on athletes to return to competition . The King-Devick ( KD ) test , an oculomotor test originally design ed for reading evaluation , was recently vali date d as a concussion screening tool in collegiate athletes . A prospect i ve study was performed using high school football players in an attempt to study the KD as a concussion screening tool in this younger population . METHODS 343 athletes from four local high school football teams were recruited to participate . These athletes were given baseline KD tests prior to competition . Individual demographic information was collected on the subjects . St and ard team protocol was employed to determine if a concussion had occurred during competition . Immediately after diagnosis , the KD test was re-administered to the concussed athlete for comparison to baseline . Post-season testing was also performed in non-concussed individuals . RESULTS Of the 343 athletes , nine were diagnosed with concussions . In all concussed players , cumulative read times for the KD test were significantly increased ( p read times relative to baseline . Univariate analysis revealed that history of concussion was the only demographic factor predictive of concussion in this cohort . CONCLUSION The KD test is an accurate and easily administered sideline screening tool for concussion in adolescent football players",
"AIM To use the King-Devick ( KD ) test and Sports Concussion Assessment Tool 2 ( SCAT2 ) in amateur rugby union players to identify witnessed and unrecognised episodes of concussion that occurred from match participation . METHODS A prospect i ve observational cohort study was conducted on a premier club level amateur rugby union team during the 2012 competition in New Zeal and . Every player completed a pre-competition question naire on concussion history , a baseline PCSS and two trials of the KD before they participated in any match activities . RESULTS For players reporting a concussion in the previous three years there was an average of 4.0±2.8 concussions per player . There were 22 concussive incidents recorded over the duration of the competition ( 46 per 1000 match hours ) . Five concussive incidents were witnessed ( 11 per 1000 match hours ) and 17 unrecognised concussive incidents were identified with the KD ( 37 per 1000 match hours ) . Witnessed concussions recorded , on average , a longer KD on the day of injury ( 5.5±2.4s ) than unrecognised concussions ( 4.4±0.9s ) when compared with their baseline KD . DISCUSSION The KD was able to identify players that had not shown , or reported , any signs or symptoms of a concussion but who had meaningful head injury . The current rate of concussion reported was a ten-fold increase in previously reported concussion injury rates . This makes the KD suitable for rapid assessment in a limited time frame on the sideline such as a five-minute window to assess and review suspected concussed players in rugby union",
"AIM To use the King-Devick ( K-D ) test in senior amateur rugby union and rugby league players over a domestic competition season to see if it could identify witnessed and unwitnessed episodes of concussion that occurred from participation in competition matches over three years . METHODS A prospect i ve observational cohort study was conducted on a club level senior amateur rugby union team ( n=36 players in 2012 and 35 players in 2013 ) and a rugby league team ( n=33 players in 2014 ) during competition seasons in New Zeal and . All 104 players completed two trials 10min apart of the K-D at the beginning of their competition season . Concussions ( witnessed or unwitnessed ) were only recorded if they were formally diagnosed by a health practitioner . RESULTS A total of 52 ( 8 witnessed ; 44 unwitnessed ) concussive events were identified over the duration of the study result ing in a concussion injury incidence of 44 ( 95 % CI : 32 to 56 ) per 1000 match participation hours . There was a six-fold difference between witnessed and unwitnessed concussions recorded . There were observable learning effects observed between the first and the second K-D test baseline testing ( 50 vs. 45s ; z=-8.81 ; p K-D test times post-match for changes in orientation ( 2.9s ) , immediate memory ( 1.8s ) concentration ( 2.8s ) , delayed recall ( 2.0s ) and SAC total score ( 1.7s ) . DISCUSSION The rate of undetected concussion was higher than detected concussions by using the K-D test routinely following matches . Worsening of the K-D test post-match was associated with reduction in components of the SAC . The appeal of the K-D test is in the rapid , easy manner of its administration and the reliable , objective results it provides to the administrator . The K-D test helped identify cognitive impairment in players without clinical ly observable symptoms",
"Abstract Disconjugate eye movements have been associated with traumatic brain injury since ancient times . Ocular motility dysfunction may be present in up to 90 % of patients with concussion or blast injury . We developed an algorithm for eye tracking in which the Cartesian coordinates of the right and left pupils are tracked over 200 sec and compared to each other as a subject watches a short film clip moving inside an aperture on a computer screen . We prospect ively eye tracked 64 normal healthy noninjured control subjects and compared findings to 75 trauma subjects with either a positive head computed tomography ( CT ) scan ( n=13 ) , negative head CT ( n=39 ) , or nonhead injury ( n=23 ) to determine whether eye tracking would reveal the disconjugate gaze associated with both structural brain injury and concussion . Tracking metrics were then correlated to the clinical concussion measure Sport Concussion Assessment Tool 3 ( SCAT3 ) in trauma patients . Five out of five measures of horizontal disconjugacy were increased in positive and negative head CT patients relative to noninjured control subjects . Only one of five vertical disconjugacy measures was significantly increased in brain-injured patients relative to controls . Linear regression analysis of all 75 trauma patients demonstrated that three metrics for horizontal disconjugacy negatively correlated with SCAT3 symptom severity score and positively correlated with total St and ardized Assessment of Concussion score . Abnormal eye-tracking metrics improved over time toward baseline in brain-injured subjects observed in follow-up . Eye tracking may help quantify the severity of ocular motility disruption associated with concussion and structural brain injury",
"Objective : The purpose was to examine the influence of a live sporting sideline environment on balance error scoring system ( BESS ) performance . Design : Prospect i ve longitudinal cohort study . Setting : The BESS was performed by all participants at 3 locations : ( 1 ) quiet laboratory , ( 2 ) football stadium sidelines , and ( 3 ) basketball arena sidelines . Participants : The experimental group had 38 participants ( age : 20.1 ± 1.1 years ; height : 170.0 ± 7.7 cm ; mass : 66.7 ± 9.5 kg ) who were female intercollegiate student-athletes ( SA ) . The control group consisted of 38 recreationally active female college students ( age : 20.8 ± 1.1 years ; height : 162.6 ± 6.0 cm ; mass : 63.7 ± 10.6 kg ) . Interventions : The 2 groups performed the tests at the same locations , the SA group during live sporting events and the control group when no event was occurring . Main Outcome Measures : The dependent variable was the total BESS score . Separate 2 × 3 mixed methods analyses of variance investigated the influence of the environment and practice effect . Results : There was a significant interaction for group by environment ( P = 0.004 ) , and the SA group committed more errors at both the football and the basketball setting s than the control group . The SA group also committed more errors at football ( P = 0.028 ) than baseline . The control group demonstrated a likely practice effect with fewer errors during each administration . Conclusions : The BESS score deteriorated when performed on the sidelines of a live sporting event potentially challenging the clinical utility of the BESS . Clinicians need to consider the role of the local environment when performing the BESS test and should perform postinjury tests in the same environment as the baseline test . Clinical Relevance : When performing balance testing of patients with suspected concussions , clinicians need to consider the environment in which the test is performed and attempt to match the preseason testing environment",
"Background Concussion is one of the most commonly occurring injuries in sport today . The Sport Concussion Assessment Tool ( SCAT ) is a commonly used paper neurocognitive tool . To date , little is known about SCAT baseline normative values in youth athletes . Objective The purpose of this study was to determine normative values on the SCAT for male and female youth hockey players . Methods This is a secondary data analysis of pooled data from three prospect i ve cohort studies examining the risk of injury in paediatric ice hockey players aged 9–17 years . A preseason baseline demographic and injury history question naire was completed by each player . Results A total of 4193 players completed SCATs at baseline and were included in the analysis . 781 players ( 18.6 % ) reported a previous history of concussion . Fatigue and low energy followed by headache were the most commonly reported symptoms in all players . The majority of youth players could recite all five words immediately but only three words when delayed . A smaller proportion of the males were able to report the months of the year in reverse order compared with females of a similar age . The median number of digits recited in reverse order was 4 . Conclusions Youth ratings varied between age groups , gender and from previously reported ratings of varsity athletes , possibly reflecting developmental and gender differences . An underst and ing of these differences in youth athletes is important to ensure appropriate performance expectations on the SCAT and when making clinical decisions following a concussion",
"BACKGROUND Each year , over 173,000 children and adolescents visit emergency departments due to sports and recreation related concussions , an increase of 60 % over the last decade due to the rise in the number of children participating in sport . While numerous authors have sought to address the epidemiology of concussions across multiple age groups who participate in contact sports , a recent review of literature did not reveal a substantial amount of published articles that addressed the issue of subconcussive contact . Multiple tools have been developed to assess acute episodes of concussion . Among the assessment protocol s many include an assessment of balance , short and long term memory recall , and balance . The Child-SCAT3 was design ed specifically to evaluate concussions in children 5 - 12 years of age . OBJECTIVE The purpose of this study was to determine the effect of a season of subconcussive contact on Child-SCAT3 scores in 8 - 12 year old males compared to their age matched peers who participated in non-contact sports . A secondary purpose was to evaluate how scores of the sub- components of the Child-SCAT3 compare between contact and non-contact athletes . DESIGN A prospect i ve cohort study was performed of 71 male athletes ( 58 football , 13 baseball ) ages 8 - 12 ( contact mean age 10.30 years , SD 1.20 ; non-contact mean age 10.03 years , SD 1.26 ) over the course of a season . METHODS Portions of The Child-SCAT3 were administered and scored in pre-adolescent athletes prior to and following a season of participation in football ( contact sport group ) and baseball ( non-contact sport group ) . The outcome measures of interest included the portions related to Cognitive ability , Balance , and Coordination . RESULTS No statistically significant differences were found in group , time or time and group interaction for any of the utilized portions of the Child-SCAT3 . Statistically significant differences were found between groups for preseason cognitive orientation and postseason immediate memory . Cognitive orientation and coordination were also found to be statistically significantly improved across both groups over the course of the season . LIMITATIONS This study was potentially limited by the number of control subjects tested . CONCLUSIONS A season of subconcussive contact in football was not detrimental to cognitive and balance scores on the Child-SCAT3 . LEVEL OF EVIDENCE 3",
"Objective : To examine the influence of age , sex , attention-deficit hyperactivity disorder ( ADHD ) status , previous history of concussion , and days since injury on postconcussion postural control assessment in adolescents who have suffered a concussion . Design : Prospect i ve cohort study . Setting : Hospital-based outpatient clinic . Participants : Seventy-one participants ( 42 males ; 29 females ) with mean age 14.14 ± 2.44 . Independent Variables : Age , sex , previous concussion history , ADHD status , total and severity of postconcussion symptoms , and days since injury . Main Outcome Measures : Total Balance Error Scoring System score , path length , center-of-pressure ( COP ) area , sample entropy , and Romberg quotient . Results : Pearson product – moment correlation coefficients were calculated to test for potential associations between the continuous participant characteristics and the postural control variables . Spearman correlation was used to test the association between symptom severity and the postural control variables . St and ard multiple regression was used to model the extent to which participant characteristics accounted for the variance in the postural sway variables . Age was significantly associated with all of the postural sway variables except COP area for the eyes open condition and sample entropy in the anterior – posterior direction for the eyes closed condition . Sex , ADHD status , and previous concussion history did not significantly predict postural control scores . Conclusions : Age significantly influences scores on common postconcussion postural control assessment s. Clinical Relevance : This study demonstrates that age is a critical factor that needs to be accounted for to improve the clinical appropriateness and utility of current postconcussion postural control assessment",
"OBJECT The authors investigated return-to-play duration for initial and recurrent concussion in the same season in 2 teams of junior ( 16 - 21-year-old ) ice hockey players during a regular season . METHODS The authors conducted a prospect i ve cohort study during 1 junior regular season ( 2009 - 2010 ) of 67 male fourth-tier ice hockey players ( mean age 18.2 ± 1.2 years [ SD ] , range 16 - 21 years ) from 2 teams . Prior to the start of the season , every player underwent baseline assessment s that were determined using the Sideline Concussion Assessment Tool 2 ( SCAT2 ) and the Immediate Post-Concussion Assessment and Cognitive Test ( ImPACT ) . The study protocol also required players who entered the study during the season to complete a baseline SCAT2 and ImPACT . If the protocol was not followed , the postinjury test results of a player without true baseline test results were compared with previously established age- and sex-matched group normative levels . Each game was directly observed by a physician and at least 1 neutral nonphysician observer . Players suspected of suffering a concussion were evaluated by the physician during the game . If a concussion was diagnosed , the player underwent clinical evaluation at the physician 's office within 24 hours . The return-to-play decision was based on clinical evaluation guided by the Zurich return-to-play protocol ( contained in the consensus statement of international expert opinion at the 3rd International Conference on Concussion in Sport held in Zurich , November 2008 ) . This clinical evaluation and return-to-play protocol was augmented by the 2 tests ( SCAT2 and ImPACT ) also recommended by the Zurich consensus statement , for which baseline values had been obtained . RESULTS Seventeen players sustained a physician-observed or self-reported , physician-diagnosed concussion during a physician-observed ice hockey game . The mean clinical return-to-play duration ( in 15 cases ) was 12.8 ± 7.02 days ( median 10 days , range 7 - 29 days ) ; the mean number of physician office visits by players who suffered a concussion ( 15 cases ) was 2.1 ± 1.29 ( median 1.5 visits ) . Five of the 17 players who sustained a concussion also suffered a recurrent or second concussion . One of the 5 individuals who suffered a repeat concussion sustained his initial concussion in a regular season game that was not observed by a physician , and as a result this single case was not included in the total of 21 concussions . This initial concussion of the player was identified during baseline testing 2 days after the injury and was subsequently medically diagnosed and treated . The mean interval between the first and second concussions in these 5 players was 78.6 ± 39.8 days ( median 82 days ) , and the mean time between the return-to-play date of the first and second concussions was 61.8 ± 39.7 days ( median 60 days ) . CONCLUSIONS The mean rates of return to play for single and recurrent concussions were higher than rates cited in recent studies involving sport concussions . The time interval between the first and second concussions was also greater than previously cited . This difference may be the result of the methodology of direct independent physician observation , diagnosis , and adherence to the Zurich return-to-play protocol",
"OBJECTIVE To prospect ively measure the immediate neurocognitive effects and early course of recovery from concussion and to examine the effects of loss of consciousness ( LOC ) and posttraumatic amnesia ( PTA ) on the severity of neurocognitive impairment immediately after concussion . METHODS A sports-related concussion research model was used to allow prospect i ve immediate evaluation of concussion . A total of 2385 high school and college football players were studied . Ninety-one players ( 3.8 % ) sustained concussions during the study . A brief neurocognitive and neurological screening measure , the St and ardized Assessment of Concussion , was used to assess cognitive functioning before the football season , immediately after injury , and 15 minutes , 48 hours , and 90 days after injury . RESULTS St and ardized Assessment of Concussion scores immediately after concussion were significantly lower than the preseason baseline score and the noninjured population baseline mean , even for injured subjects without LOC or PTA . Subjects with LOC were most severely impaired immediately after injury , whereas those without LOC or PTA were least impaired . Significant impairment was also detected 15 minutes after injury , but all three groups returned to baseline levels of cognitive functioning within 48 hours . CONCLUSION These findings are the first to demonstrate not only that a gradient of increasing concussion severity is represented by PTA and LOC but also that measurable neurocognitive abnormalities are evident immediately after injury without PTA or LOC",
"CONTEXT Lack of empirical data on recovery time following sport-related concussion hampers clinical decision making about return to play after injury . OBJECTIVE To prospect ively measure immediate effects and natural recovery course relating to symptoms , cognitive functioning , and postural stability following sport-related concussion . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 1631 football players from 15 US colleges . All players underwent preseason baseline testing on concussion assessment measures in 1999 , 2000 , and 2001 . Ninety-four players with concussion ( based on American Academy of Neurology criteria ) and 56 noninjured controls underwent assessment of symptoms , cognitive functioning , and postural stability immediately , 3 hours , and 1 , 2 , 3 , 5 , 7 , and 90 days after injury . MAIN OUTCOME MEASURES Scores on the Grade d Symptom Checklist ( GSC ) , St and ardized Assessment of Concussion ( SAC ) , Balance Error Scoring System ( BESS ) , and a neuropsychological test battery . RESULTS No player with concussion was excluded from participation ; 79 players with concussion ( 84 % ) completed the protocol through day 90 . Players with concussion exhibited more severe symptoms ( mean GSC score 20.93 [ 95 % confidence interval [ CI ] , 15.65 - 26.21 ] points higher than that of controls ) , cognitive impairment ( mean SAC score 2.94 [ 95 % CI , 1.50 - 4.38 ] points lower than that of controls ) , and balance problems ( mean BESS score 5.81 [ 95 % CI , -0.67 to 12.30 ] points higher than that of controls ) immediately after concussion . On average , symptoms gradually resolved by day 7 ( GSC mean difference , 0.33 ; 95 % CI , -1.41 to 2.06 ) , cognitive functioning improved to baseline levels within 5 to 7 days ( day 7 SAC mean difference , -0.03 ; 95 % CI , -1.33 to 1.26 ) , and balance deficits dissipated within 3 to 5 days after injury ( day 5 BESS mean difference , -0.31 ; 95 % CI , -3.02 to 2.40 ) . Mild impairments in cognitive processing and verbal memory evident on neuropsychological testing 2 days after concussion resolved by day 7 . There were no significant differences in symptoms or functional impairments in the concussion and control groups 90 days after concussion . CONCLUSIONS Collegiate football players may require several days for recovery of symptoms , cognitive dysfunction , and postural instability after concussion . Further research is required to determine factors that predict variability in recovery time after concussion . St and ardized measurement of postconcussive symptoms , cognitive functioning , and postural stability may enhance clinical management of athletes recovering from concussion",
"AIM This study undertook to use the K-D sideline test with the SCAT2 to see if concussions could be identified in amateur rugby league players over a representative competition period . METHOD A prospect i ve cohort study was conducted on two teams participating in an amateur rugby league . All players were tested for signs of concussion utilising the K-D test and players with longer times than their baseline scores undertook a further concussion assessment with the SCAT2 . RESULTS Five athletes with suspected concussion were evaluated by K-D testing . Three concussions were associated with witnessed events during the matches and two athletes were identified by the team medic as having longer K-D time scores incidentally post-match compared to baseline . Post-match K-D scores for all concussed athletes were worse than baseline for those with reported or witnessed concussion events ( 7s ; 5.0 - 7.1 ; p=0.025 ) and for those identified incidentally ( > 5s ; 8.9 - 9.1s ) . Both groups also reported more symptoms on the PCSS ( a part of the SCAT2 ) post-match . DISCUSSION In this rugby cohort , the K-D test was not only useful in identifying changes in players with witnessed head trauma , but in identifying changes in players with an un-witnessed suspected concussion",
"OBJECT Pediatric sports-related concussions are a growing public health concern . The factors that determine injury severity and time to recovery following these concussions are poorly understood . Previous studies suggest that initial symptom severity and diagnosis of attention deficit hyperactivity disorder ( ADHD ) are predictors of prolonged recovery ( > 28 days ) after pediatric sports-related concussions . Further analysis of baseline patient characteristics may allow for a more accurate prediction of which patients are at risk for delayed recovery after a sports-related concussion . METHODS The authors performed a single-center retrospective case-control study involving patients cared for at the multidisciplinary Concussion Clinic at Children 's of Alabama between August 2011 and January 2013 . Patient demographic data , medical history , sport concussion assessment tool 2 ( SCAT2 ) and symptom severity scores , injury characteristics , and patient balance assessment s were analyzed for each outcome group . The control group consisted of patients whose symptoms resolved within 28 days . The case group included patients whose symptoms persisted for more than 28 days . The presence or absence of the SCAT2 assessment had a modifying effect on the risk for delayed recovery ; therefore , stratum-specific analyses were conducted for patients with recorded SCAT2 scores and for patients without SCAT2 scores . Unadjusted ORs and adjusted ORs ( aORs ) for an association of delayed recovery outcome with specific risk factors were calculated with logistic regression analysis . RESULTS A total of 294 patients met the inclusion criteria of the study . The case and control groups did not statistically significantly differ in age ( p = 0.7 ) . For the patients who had received SCAT2 assessment s , a previous history of concussion ( aOR 3.67 , 95 % CI 1.51 - 8.95 ) , presenting SCAT2 score risk for postconcussive symptoms lasting more than 28 days . For patients without SCAT2 scores , female sex and reporting a history of ADHD significantly increased the odds of prolonged recovery ( aOR 4.41 , 95 % CI 1.93 - 10.07 and aOR 3.87 , 95 % CI 1.13 - 13.24 , respectively ) . Concussions result ing from playing a nonhelmet sport were also associated with a higher risk for prolonged symptoms in patients with and without SCAT2 scores ( OR 2.59 , 95 % CI 1.28 - 5.26 and OR 2.17 , 95 % CI 0.99 - 7.73 , respectively ) . Amnesia , balance abnormalities , and a history of migraines were not associated with symptoms lasting longer than 28 days . CONCLUSIONS This case-control study suggests c and i date risk factors for predicting prolonged recovery following sports-related concussion . Large prospect i ve cohort studies of youth athletes examined and treated with st and ardized protocol s will be needed to definitively establish these associations and confirm which children are at highest risk for delayed recovery",
"The purpose of this study was to investigate the sensitivity of orientation and recent memory questions in the diagnosis of concussion . In a prospect i ve study over 7 consecutive years ( 1985 - 1991 ) , all players at a professional Australian Rules Football club who sustained a concussive injury ( n = 28 ) were administered a set of questions evaluating orientation and recent memory . Concussion was diagnosed independently on the basis of loss or disturbance of consciousness and clinical symptoms . A control group of age-matched nonconcussed players was administered the same set of questions . The results showed that items evaluating recently acquired information were more sensitive in the assessment of concussion than st and ard orientation items . The relative sensitivity of orientation questions must be considered when they are used in the clinical diagnosis of concussion in sport",
"OBJECT The objective of this study was to measure the incidence of concussion ( scaled relative to number of athlete exposures ) and recurrent concussion within 2 teams of fourth-tier junior ice hockey players ( 16 - 21 years old ) during 1 regular season . METHODS A prospect i ve cohort study called the Hockey Concussion Education Project was conducted during 1 junior ice hockey regular season ( 2009 - 2010 ) involving 67 male fourth-tier ice hockey players ( mean age 18.2 ± 1.2 years , range 16 - 21 years ) from 2 teams . Prior to the start of the season , every player underwent baseline assessment s using the Sideline Concussion Assessment Tool 2 ( SCAT2 ) and the Immediate Post-Concussion Assessment and Cognitive Test ( ImPACT ) . The study protocol also required players who entered the study during the season to complete baseline SCAT2 and ImPACT testing . If the protocol was not followed , the postinjury test results of a player without true baseline test results would be compared against previously established age and gender group normative levels . Each regular season game was observed by a qualified physician and at least 1 other neutral nonphysician observer . Players who suffered a suspected concussion were evaluated at the game . If a concussion diagnosis was made , the player was subsequently examined in the physician 's office for a full clinical evaluation and the SCAT2 and ImPACT were repeated . Based on these evaluations , players were counseled on the decision of when to return to play . Athlete exposure was defined as 1 game played by 1 athlete . RESULTS Twenty-one concussions occurred during the 52 physician-observed games ( incidence 21.5 concussions per 1000 athlete exposures ) . Five players experienced repeat concussions . No concussions were reported during practice sessions . A concussion was diagnosed by the physician in 19 ( 36.5 % ) of the 52 observed games . One of the 5 individuals who suffered a repeat concussion sustained his initial concussion in a regular season game that was not observed by a physician , and as a result this single case was not included in the total of 21 total concussions . This initial concussion of the player was identified during baseline testing 2 days after the injury and was subsequently medically diagnosed and treated . CONCLUSIONS The incidence of game-related concussions ( per 100 [ corrected ] athlete exposures ) in these fourth-tier junior [ corrected ] ice hockey players was 7 [ corrected ] times higher than [ corrected ] previously reported in the literature . This difference may be the result of the use of st and ardized direct physician observation , diagnosis , and subsequent treatment . The results of this study demonstrate the need for follow-up studies involving larger and more diverse sample groups to reflect generalizability of the findings . These follow-up studies should involve other contact sports ( for example football and rugby ) and also include the full spectrum of gender , age , and skill levels ",
"AIM To determine whether the King-Devick ( K-D ) test used as a sideline test in junior rugby league players over 12 matches in a domestic competition season could identify witnessed and incidentally identified episodes of concussion . METHODS A prospect i ve observational cohort study of a club level junior rugby league team ( n=19 ) during the 2014 New Zeal and competition season involved every player completing two pre-competition season baseline trials of the K-D test . Players removed from match participation , or who reported any signs or symptoms of concussion were assessed on the sideline with the K-D test and referred for further medical assessment . Players with a pre- to post-match K-D test difference > 3s were referred for physician evaluation . RESULTS The baseline test-retest reliability of the K-D test was high ( rs=0.86 ; p concussions were medically identified in six players who recorded pre- to post-match K-D test times greater than 3s ( mean change of 7.4s ) . Post-season testing of players demonstrated improvement of K-D time scores consistent with learning effects of using the K-D test ( 67.7s vs. 62.2s ) . DISCUSSION Although no witnessed concussions occurred during rugby play , six players recorded pre- to post-match changes with a mean delay of 4s result ing in seven concussions being subsequently confirmed post-match by health practitioners . All players were medically managed for a return to sports participation . CONCLUSION The K-D test was quickly and easily administered making it a practical sideline tool as part of the continuum of concussion assessment tools for junior rugby league players",
"OBJECTIVES The objective of this study was to determine the reliability and validity of identifying clinical signs of concussion using video analysis in Australian football . DESIGN Prospect i ve cohort study . METHODS All impacts and collisions potentially result ing in a concussion were identified during 2012 and 2013 Australian Football League seasons . Consensus definitions were developed for clinical signs associated with concussion . For intra- and inter-rater reliability analysis , two experienced clinicians independently assessed 102 r and omly selected videos on two occasions . Sensitivity , specificity , positive and negative predictive values were calculated based on the diagnosis provided by team medical staff . RESULTS 212 incidents result ing in possible concussion were identified in 414 Australian Football League games . The intra-rater reliability of the video-based identification of signs associated with concussion was good to excellent . Inter-rater reliability was good to excellent for impact seizure , slow to get up , motor incoordination , ragdoll appearance ( 2 of 4 analyses ) , clutching at head and facial injury . Inter-rater reliability for loss of responsiveness and blank and vacant look was only fair and did not reach statistical significance . The feature with the highest sensitivity was slow to get up ( 87 % ) , but this sign had a low specificity ( 19 % ) . Other video signs had a high specificity but low sensitivity . Blank and vacant look ( 100 % ) and motor incoordination ( 81 % ) had the highest positive predictive value . CONCLUSIONS Video analysis may be a useful adjunct to the side-line assessment of a possible concussion . Video analysis however should not replace the need for a thorough multimodal clinical assessment",
"PURPOSE We have developed a reliable and valid clinical test of reaction time ( RTclin ) that is sensitive to the acute effects of concussion . If RTclin is to be used as a sideline concussion assessment tool then the acute effects of exercise on RTclin may need to be controlled for . The purpose of this study was therefore to determine the effect of exercise on RTclin . METHODS A gender-balanced group of 42 collegiate athletes were assigned to an exercise ( n = 28 ) and a control ( n = 14 ) group using 2:1 block r and omization . The exercise group completed a grade d four-stage exercise protocol on a stationary bicycle ( 100 W × 5 min ; 150 W × 5 min ; 200 W × 5 min ; sprint × 2 min ) , whereas the control group was tested at identical periods without exercising . Mean RTclin was calculated for eight trials as the fall time of a vertically suspended rigid shaft after its release by the examiner before being caught by the athlete . RTclin was measured at baseline and after each of the four stages . RESULTS As both HR and RPE significantly increased for the four stages in the exercise group ( P 0.001 ) , mean RTclin showed a significant overall decline during repeated test administration ( P ( exercise vs control , P = 0.822 ) or group-by-stage interaction ( P = 0.169 ) effects on RTclin as assessed by repeated- measures analysis of variance . CONCLUSIONS Exercise did not appear to affect RTclin performance in this study . This suggests that RTclin measured during a sideline concussion assessment does not need to be adjusted to account for the acute effects of exercise"
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PURPOSE Osteoporotic fracture is the main complication of osteoporosis . The current management is to discharge patients as early as possible so they can get back to their daily activities . Once discharged , there are three main issues relating to morbidity , mortality , and risk of a subsequent fracture that need to be addressed and discussed . Therefore , the aim of this systematic review was to summarize and evaluate the evidence from published literature , to determine the outcome of osteoporotic fracture patients after their hospital discharge . METHODS The MEDLINE and Cumulative Index to Nursing and Allied Health Literature ( CINAHL ) data bases were search ed , using the terms " osteoporosis " , " fracture " , " osteoporotic fracture " , " hip fracture " , and " vertebral fracture " . We included only human studies published in English between 2004 and 2014 . The reference lists of included studies were thoroughly review ed in search for other relevant studies . RESULTS A total of 18 studies met the selection criteria . Most were observational and cohort studies . Out of all the studies , five studies looked into the morbidity , six studies looked into the risk of subsequent fractures , and seven studies looked into mortality . Vertebral fracture caused the greatest health burden , but hip fracture patients were the main users of informal care after hospital discharge . There was an increased risk of a subsequent fracture after a primary fracture compared with the control group , a cohort comparison , or the general population . Osteoporotic fractures , especially hip fractures , are associated with higher mortality rate despite the advances in the management of osteoporotic fracture cases . CONCLUSION There is strong evidence to show that after hospital discharge , osteoporotic fracture patients are faced with higher morbidity , subsequent fractures , and mortality
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"CONTEXT There are few data on long-term mortality following osteoporotic fracture and fewer following subsequent fracture . OBJECTIVES To examine long-term mortality risk in women and men following all osteoporotic fractures and to assess the association of subsequent fracture with that risk . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort from the Dubbo Osteoporosis Epidemiology Study of community-dwelling women and men aged 60 years and older from Dubbo , Australia , who sustained a fracture between April 1989 and May 2007 . MAIN OUTCOME MEASURES Age- and sex-specific st and ardized mortality ratios ( SMRs ) compared with the overall Dubbo population for hip , vertebral , major , and minor fractures . RESULTS In women , there were 952 low-trauma fractures followed by 461 deaths , and in men , 343 fractures were followed by 197 deaths . Age-adjusted SMRs were increased following hip fractures ( SMRs , 2.43 [ 95 % confidence interval [ CI ] , 2.02 - 2.93 ] and 3.51 [ 95 % CI , 2.65 - 4.66 ] ) , vertebral fractures ( SMRs , 1.82 [ 95 % CI , 1.52 - 2.17 ] and 2.12 [ 95 % CI , 1.66 - 2.72 ] ) , major fractures ( SMRs , 1.65 [ 95 % CI , 1.31 - 2.08 ] and 1.70 [ 95 % CI , 1.23 - 2.36 ] ) , and minor fractures ( SMRs , 1.42 [ 95 % CI , 1.19 - 1.70 ] and 1.33 [ 95 % CI , 0.99 - 1.80 ] ) for both women and men , respectively . Mortality was increased for all ages for all fractures except minor fractures for which increased mortality was only apparent for those older than 75 years . Increased mortality risk persisted for 5 years for all fractures and up to 10 years for hip fractures . Increases in absolute mortality that were above expected , for 5 years after fracture , ranged from 1.3 to 13.2 per 100 person-years in women and from 2.7 to 22.3 per 100 person-years in men , depending on fracture type . Subsequent fracture was associated with an increased mortality hazard ratio of 1.91 ( 95 % CI , 1.54 - 2.37 ) in women and 2.99 ( 95 % CI , 2.11 - 4.24 ) in men . Mortality risk following a subsequent fracture then declined but beyond 5 years still remained higher than in the general population ( SMR , 1.41 [ 95 % CI , 1.01 - 1.97 ] and SMR , 1.78 [ 95 % CI , 0.96 - 3.31 ] for women and men , respectively ) . Predictors of mortality after any fragility fracture for both men and women included age , quadriceps weakness , and subsequent fracture but not comorbidities . Low bone mineral density , having smoked , and sway were also predictors for women and less physical activity for men . CONCLUSIONS In a sample of older women and men , all low-trauma fractures were associated with increased mortality risk for 5 to 10 years . Subsequent fracture was associated with increased mortality risk for an additional 5 years",
"OBJECTIVE --To study the mortality and morbidity associated with proximal femoral fractures with reference to fracture type ( intracapsular and extracapsular ) . DESIGN --Consecutive prospect i ve study with 12 month follow ups . SETTING --Two British trauma receiving centres . PATIENTS --1000 consecutive acute proximal femoral fractures ( fractured necks of femur ) in 972 patients . RESULTS --Significantly higher mortality at one year was seen in patients with extracapsular fractures ( 188/490 ; 38 % ) than in those with intracapsular fractures ( 147/510 ; 29 % ; p morbidity was experienced during the study period by patients with extracapsular fractures , who were less mobile and less independent at the time of their injury . CONCLUSIONS --The rise in average age of presentation with proximal femoral fracture is associated with a persistently high mortality ( 33 % ) and morbidity , greater in patients with an extracapsular fracture . Comparison with other studies , principally from outside Britain , is difficult , but despite advancing st and ards of care the mortality and morbidity of femoral neck fractures remains high , placing an ever increasing burden on the health service",
"Background : Fractures have largely been assessed by their impact on quality of life or health care costs . We conducted this study to evaluate the relation between fractures and mortality . Methods : A total of 7753 r and omly selected people ( 2187 men and 5566 women ) aged 50 years and older from across Canada participated in a 5-year observational cohort study . Incident fractures were identified on the basis of vali date d self-report and were classified by type ( vertebral , pelvic , forearm or wrist , rib , hip and “ other ” ) . We subdivided fracture groups by the year in which the fracture occurred during follow-up ; those occurring in the fourth and fifth years were grouped together . We examined the relation between the time of the incident fracture and death . Results : Compared with participants who had no fracture during follow-up , those who had a vertebral fracture in the second year were at increased risk of death ( adjusted hazard ratio [ HR ] 2.7 , 95 % confidence interval [ CI ] 1.1–6.6 ) ; also at risk were those who had a hip fracture during the first year ( adjusted HR 3.2 , 95 % CI 1.4–7.4 ) . Among women , the risk of death was increased for those with a vertebral fracture during the first year ( adjusted HR 3.7 , 95 % CI 1.1–12.8 ) or the second year of follow-up ( adjusted HR 3.2 , 95 % CI 1.2–8.1 ) . The risk of death was also increased among women with hip fracture during the first year of follow-up ( adjusted HR 3.0 , 95 % CI 1.0–8.7 ) . Interpretation : Vertebral and hip fractures are associated with an increased risk of death . Interventions that reduce the incidence of these fractures need to be implemented to improve survival ",
"OBJECTIVES To evaluate the incremental cost in the year after hip fracture . DESIGN Prospect i ve cohort study . SETTING Baltimore , Maryl and . PARTICIPANTS 759 community dwelling older patients who sustained a hip fracture and participated in the Baltimore Hip Fracture Study . MEASUREMENTS Re source use for direct medical care , formal nonmedical care , and informal care in the 6 months before and the year after fracture was estimated from interviews with patients or proxy respondents . Costs in 1993 dollars were estimated by multiplying re sources times national unit cost estimates . RESULTS The annualized costs in the year before the fracture ranged between $ 18,523 and $ 20,928 . The costs in the year after the fracture equaled $ 37,250 . The incremental costs in the year after the fracture , compared with the costs in the year before the fracture , ranged between $ 16,322 and $ 18,727 . The largest cost differences were attributable to hospitalizations , nursing home stays , and rehabilitation services . CONCLUSIONS Because we compared the costs after a fracture with costs before , our estimates of the incremental cost of a hip fracture are lower than others in the literature . These results , obtained from interviews with patients enrolled in a cohort study , or their proxies , provide the best data available to date on the economic cost of hip fractures among community-dwelling older persons",
"BACKGROUND underst and ing the determinants of health burden after a fracture in ageing population s is important . OBJECTIVE assess the effect of clinical vertebral and other osteoporotic fractures on function and the subsequent risk of hospitalisation . DESIGN individuals from the prospect i ve population -based cohort study Age , Gene/Environment Susceptibility (AGES)-Reykjavik study were examined between 2002 and 2006 and followed up for 5.4 years . SUBJECTS a total of 5,764 individuals , 57.7 % women , born 1907 - 35 , mean age 77 . METHOD four groups with a verified fracture status were used ; vertebral fractures , other osteoporotic fractures excluding vertebral , non-osteoporotic fractures and not-fractured were compared and analysed for the effect on mobility , strength , QoL , ADL , co-morbidity and hospitalisation . RESULTS worst performance on functional tests was in the vertebral fracture group for women ( P risk of hospitalisation , HR = 1.4 ( 95 % CI : 1.3 - 1.7 ) and 1.2 ( 95 % CI : 1.1 - 1.2 ) respectively ( P hospitalisation than not-fractured and 33 % ( P < 0.002 ) longer than the other osteoporotic fractures group . CONCLUSION individuals with a history of clinical vertebral fracture seem to carry the greatest health burden compared with other fracture groups , emphasising the attention which should be given to those individuals",
"CONTEXT There are few published long-term data on absolute risk of subsequent fracture ( refracture ) following initial low-trauma fracture in women and fewer in men . OBJECTIVE To examine long-term risk of subsequent fracture following initial osteoporotic fracture in men and women . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study ( Dubbo Osteoporosis Epidemiology Study ) in Australia of 2245 community-dwelling women and 1760 men aged 60 years or older followed up for 16 years from July 1989 through April 2005 . MAIN OUTCOME MEASURE Incidence of first ( initial ) fracture and incidence of subsequent fracture according to sex , age group , and time since first fracture . Relative risk was determined by comparing risk of subsequent fracture with risk of initial fracture . RESULTS There were 905 women and 337 men with an initial fracture , of whom 253 women and 71 men experienced a subsequent fracture . Relative risk ( RR ) of subsequent fracture in women was 1.95 ( 95 % confidence interval [ CI ] , 1.70 - 2.25 ) and in men was 3.47 ( 95 % CI , 2.68 - 4.48 ) . As a result , absolute risk of subsequent fracture was similar in women and men and at least as great as the initial fracture risk for a woman 10 years older . Thus , women and men aged 60 to 69 years had absolute refracture rates of 36/1000 person-years ( 95 % CI , 26 - 48/1000 ) and 37/1000 person-years ( 95 % CI , 23 - 59/1000 ) , respectively . The increase in absolute fracture risk remained for up to 10 years , by which time 40 % to 60 % of surviving women and men experienced a subsequent fracture . All fracture locations apart from rib ( men ) and ankle ( women ) result ed in increased subsequent fracture risk , with highest RRs following hip ( RR , 9.97 ; 95 % CI , 1.38 - 71.98 ) and clinical vertebral ( RR , 15.12 ; 95 % CI , 6.06 - 37.69 ) fractures in younger men . In multivariate analyses , femoral neck bone mineral density , age , and smoking were predictors of subsequent fracture in women and femoral neck bone mineral density , physical activity , and calcium intake were predictors in men . CONCLUSION After an initial low-trauma fracture , absolute risk of subsequent fracture was similar for men and women . This increased risk occurred for virtually all clinical fractures and persisted for up to 10 years",
"Summary In the present prospect i ve controlled observational study , we investigated the effect of a coordinated intervention program on 4-year refracture rates in patients with recent osteoporotic fractures . Compared to st and ard care , targeted identification , and management significantly reduced the risk of refracture by more than 80 % . Introduction The risk of refracture following an incident osteoporotic fracture is high . Despite the availability of treatments that reduce refracture and mortality rates , most patients with minimal trauma fracture ( MTF ) are not managed appropriately . The present prospect i ve controlled observational study investigated the effect of a coordinated intervention program on 4-year refracture rates and time to refracture in patients with recent osteoporotic fractures . Methods Patients presenting with a non-vertebral MTF were actively identified and offered referral to a dedicated intervention program . Patients attending the clinic underwent a st and ardized set of investigations , were treated as indicated and review ed at 12-monthly intervals ( ‘ MTF group ’ ) . Patients who elected to follow-up with their primary care physician were assigned to the concurrent control group . Results Groups were balanced for baseline anthropometric , socio-economic , and clinical risk factors . Over 4 years , 10 out of 246 patients ( 4.1 % ) in the MTF group and 31 of 157 patients ( 19.7 % ) in the control group suffered a new fracture , with a median time to refracture of 26 and 16 months , respectively ( p risk of refracture was increased by 5.3-fold in the control group ( 95 % CI : 2.8–12.2 , p patients presenting with a minimal trauma non-vertebral fracture , active identification and management significantly reduces the risk of refracture ( Australian New Zeal and Clinical Trials Registry ACTRN 12606000108516 )",
"UNLABELLED The level of recognition and treatment of osteoporosis is not well characterized in primary care . In data from a large sample of postmenopausal women attending 927 primary care physicians , 29 % of women reported one or more fractures after menopause . The great majority ( 72 % ) were not on any osteoporosis-specific therapy . INTRODUCTION Osteoporosis is often first recognized at the time of a low-trauma fracture . However , by this stage , the risk of subsequent fractures has already risen substantially . Moreover , in many countries , only a small proportion of women , who have already sustained fractures , receive a treatment shown to reduce this increased risk of further fractures . MATERIAL S AND METHODS This project was initiated to examine the prevalence of osteoporotic fractures , risk factors for osteoporosis , and use of antifracture therapy among postmenopausal Australian women . More than 88,000 women from 927 primary care physicians returned over 69,358 surveys . Of these , 57,088 reported the presence of a postmenopausal fracture or risk factors . RESULTS Among these r and omly selected postmenopausal women , 29 % reported having had one or more low-trauma fractures after menopause ( 44 % substantiated in current records ) . One-third of these women reported multiple fractures . The prevalence of all types of fractures , except rib and ankle , increased with age and low body weight . Those who reported fractures were also more likely to report early menopause , corticosteroid use , and a family history of osteoporosis . Moreover , those with vertebral fractures were more likely to record height loss , kyphosis , and back pain . Physical inactivity , low calcium intake , and smoking had no consistent relationship with any fracture outcome . Of the women who reported a fracture after menopause , only 28 % were on any specific therapy for osteoporosis , and 7 % were on calcium alone . Of those who had been told they had osteoporosis by a doctor , 40 % were receiving specific osteoporosis therapy . CONCLUSIONS In this large study of postmenopausal Australian women attending primary care physicians , 29 % reported at least one low-trauma fracture after menopause . Less than one-third of these women were on specific treatment for osteoporosis , and only 40 % were ever told they had osteoporosis . Therefore , osteoporotic fractures are common in postmenopausal Australian women , and few , despite their substantially increased risk of further fractures , are on any specific anti-osteoporotic therapy . These data support the need for more effective education for the community and medical practitioners of the clinical significance of osteoporotic fractures and alternatives for treatment",
"BACKGROUND Vertebral fractures are common and usually an indication for osteoporosis treatment . However , screening is not recommended , and many fractures go undetected . Our objectives were to determine the utility of chest radiographs for detecting previously unrecognized vertebral fractures ; document rates of recognition ; and evaluate osteoporosis treatments . METHODS In 2001 , we conducted a cohort study in a r and om sample of 500 patients older than 60 years who presented to our emergency department and underwent chest radiography for any indication . The primary outcome was prevalence of moderate-to-severe vertebral fractures determined by independent radiograph review using vali date d semiquantitative techniques . Secondary outcomes were rates of fracture recognition according to official radiologists ' reports and rates of osteoporosis diagnosis and treatment . We conducted multivariable regression analyses to determine correlates of study -defined and officially reported fractures . RESULTS We excluded 36 patients with inadequate radiographs and 5 for other reasons . Mean age was 75.2 years ; 47 % were women ; and 80 % were white . The prevalence of moderate-to-severe vertebral fractures according to independent review was 72 ( 16 % ) of 459 ; 29 ( 40 % ) of these fractures were not recorded in the official radiologists ' report ( kappa = 0.64 ; 95 % confidence interval [ CI ] , 0.53 - 0.75 ) . A history of osteoporosis was the only independent correlate of having a vertebral fracture identified by independent review ( adjusted odds ratio [ OR ] , 2.18 ; 95 % CI , 1.14 - 4.17 ) or by official report ( adjusted OR , 4.97 ; 95 % CI , 0.95 - 25.86 ) . Of the 72 patients with fractures , only 18 ( 25 % ) had histories of osteoporosis or received osteoporosis medications . CONCLUSIONS One in 6 elderly patients who underwent chest radiography in our emergency department had clinical ly important vertebral fractures . Nevertheless , only 43 ( 60 % ) of these fractures were reported , and only 25 % of patients with fractures received a diagnosis of or treatment for osteoporosis",
"Context Many patients who sustain fragility fractures do not receive subsequent testing and treatment for osteoporosis . Contribution This study shows that faxed reminders to physicians , treatment guidelines endorsed by opinion leaders , and patient education about osteoporosis can increase the testing and therapy for osteoporosis among patients who present to an emergency department with wrist fracture . Caution s This study did not r and omly assign persons to the intervention group and did not examine improvements in bone density or repeated fractures . The Editors Osteoporosis , a chronic and progressive condition that leads to decreased bone mass and skeletal fragility , may result in fractures , disability , pain , deformity , and even death ( 1 - 3 ) . The condition is common , affecting an estimated 1.4 million Canadians and 10 million Americans ( 1 , 2 ) . These figures represent 25 % of women and 12 % of men older than 50 years of age ( 1 , 2 ) . In the United States , the annual cost of treating osteoporosis and its sequelae has been estimated at $ 13.8 billion ( 2 ) , compared with $ 7.5 billion for congestive heart failure and $ 6.2 billion for asthma ( 3 ) . Without better preventive strategies , the rate of osteoporotic fractures is expected to double over the next 15 years ( 4 ) . Several experts ( 5 ) and guidelines ( 1 , 2 ) suggest a preventive strategy of identifying people with typical osteoporosis-related fractures ( for example , fractures of the hip , spine , or wrist [ often called fragility fractures ] ) and targeting them for treatment . They recommend this strategy because this population is at the greatest risk for subsequent fracture and may derive the greatest absolute benefit from treatment . Numerous safe and effective treatments can reduce the risk for recurrent fracture by 40 % to 60 % ( 1 - 3 , 6 ) . In addition , with the use of bisphosphonates and raloxifene , all subgroups of examined patients may obtain beneficial effects ( 3 , 7 - 9 ) within a year ( 7 , 8) . People 50 years of age and older with a fracture of the wrist may be particularly well suited to a strategy of case finding and secondary prevention . Fractures of the wrist are the most common symptomatic fracture related to osteoporosis ( 3 ) , and 70 % to 80 % of persons with wrist fractures have low bone mass ( 10 , 11 ) . Observational studies suggest that a wrist fracture is a sentinel event in the natural history of osteoporosis because this type of fracture forecasts an increased risk for fractures of the hip and spine over the next 10 to 20 years ( 12 - 14 ) . Best practice ( clinical practice consistent with current evidence and expert consensus ) would be to identify people 50 years of age or older with a fragility fracture of the wrist , to measure their bone mineral density , and to treat those with low bone mass or osteoporosis ( 1 , 2 , 5 ) . However , the gap between best practice and everyday clinical practice is wide . Over the past 5 to 10 years , studies from the United States ( 3 , 15 , 16 ) , Canada ( 17 , 18 ) , and elsewhere ( 5 , 19 ) report that rates of testing for and treating osteoporosis a year or longer after a fracture of the wrist are less than 10 % to 20 % . This is an important failure in the process of knowledge translation and indicates that benefits within our reach are not being achieved . We design ed a pragmatic , multifaceted osteoporosis intervention strategy directed at people 50 years of age or older with a fracture of the wrist and at their primary care physicians . The intervention consisted of physician reminders , treatment guidelines endorsed by local opinion leaders , and patient education . Our primary objective was to examine whether this intervention improved the diagnosis and treatment of osteoporosis in this high-risk population . Secondary objectives included examining the effect of this intervention on patients ' knowledge , satisfaction , and quality of life . Methods Setting and Participants Capital Health ( Edmonton , Alberta ) is one of the largest integrated health service delivery organizations in Canada ( 20 ) . It provides comprehensive health services for about 1 million people and has an annual budget of almost $ 2 billion ( Canadian ) ( 20 ) . Primary care is delivered by approximately 900 fee-for-service physicians . We enrolled participants from the 2 largest emergency departments in the region : the University of Alberta Hospital ( a university-based teaching hospital ) and the Royal Alex and ra Hospital ( a university-affiliated community teaching hospital ) . These emergency departments provide most of the fracture care and emergency orthopedic services to the region . Consecutive patients presenting to the emergency department with a wrist fracture were potentially eligible . Inclusion criteria were as follows : age 50 years or older ; any simple , closed fracture of the distal forearm ; and discharge home . We excluded patients who were already taking prescription treatments for osteoporosis . Because we did not ask patients whether they had a diagnosis of osteoporosis until study closeout , a patient with a history of osteoporosis who was not being treated with prescription medication was potentially eligible for inclusion . We also excluded patients who were unable to provide consent , were unwilling to participate , were admitted to the hospital , resided in a long-term care facility , resided outside the Capital Health region , or could not read and converse in English . Study Design and Patient Enrollment We conducted a prospect i ve controlled trial with blinded ascertainment of outcomes . To allocate patients to the intervention or usual care control groups , we adapted and modified an onoff 1-site study design for 2 sites ( 21 ) . For 1 month at a time , in sequential order , the intervention was on at 1 emergency department while it was off at the other . At the end of each month , research nurses alternated intervention status from on to off or vice versa . Patients with wrist fractures were treated , as appropriate , by emergency department physicians and then approached by research nurses or orthopedic technicians for enrollment in the study before discharge home . We obtained informed consent from each patient , and all data were maintained outside the emergency departments in a central ized secure file system . The University of Alberta Health Research Ethics Board approved the study . Intervention We design ed an intervention to overcome the many barriers that exist for primary care physicians who are trying to adopt evidence -based treatments for their patients with osteoporosis . Each of the 3 components of the intervention had published evidence of effectiveness ( 22 - 24 ) . Physician Reminders A reminder was generated for each patient and faxed to the primary care physician of record . The reminder notified physicians that their patient had recently been seen and treated in the emergency department for a wrist fracture and reminded them that their patient was now considered to be at increased risk for osteoporosis . Generating and sending the personalized and patient-specific reminder took about 6 minutes for each patient . Treatment Guidelines Generated and Endorsed by Opinion Leaders As part of the reminder , we provided brief evidence -based treatment recommendations . These guidelines were design ed to fit on the same page and emphasized 3 points : 1 ) The patient is at very high risk for osteoporosis and needs a bone mineral density measurement if one has not been performed in the past year ; 2 ) without treatment , the patient may be at increased risk for another fracture within the year ; and 3 ) bisphosphonate treatment will reduce the patient 's risk for fracture by about 50 % . Bisphosphonate alternatives ( for example , calcitonin , raloxifene , and hormone therapy ) were mentioned as second-line approved treatments because , at the time of study design , only the bisphosphonates had been demonstrated to prevent both vertebral and nonvertebral fractures . Using previously vali date d methods ( 25 , 26 ) , we recruited 5 osteoporosis opinion leaders who had been nominated by local primary care providers . The opinion leaders helped develop and then endorsed the guidelines by attaching their names and signatures . Patient Education We provided patients in the intervention group with a tailored , single-page summary of osteoporosis information that mirrored the physician material s described in the preceding paragraph . We reinforced these written material s with a brief telephone counseling session that took place within 1 week of the fracture . This counseling ( approximately 4 minutes per session ) reiterated the content of the written material s and encouraged patients to seek further information and counseling from their primary care physician . We did not provide intervention patients with any written material s or counseling regarding fall prevention or home safety . Control Patients ( Usual Care ) On the basis of surveys and in-depth interviews with emergency department physicians in Canada and the United States , the current st and ard of care for patients treated for a wrist fracture usually consists of 1 ) notification to the primary care physician of record that the patient was seen and treated and 2 ) information on follow-up plans . We ensured that such notifications occurred for all control patients . In addition , we enhanced usual care by ensuring that control patients received educational material s and telephone counseling regarding fall prevention and home safety . During the call , patients were encouraged to visit their primary care physician for more detailed advice and a medication review . They did not receive any counseling or educational material s about osteoporosis . Thus , control patients received the same amount of attention and care as the intervention patients . After the main study was completed , all control patients were crossed over to the osteoporosis intervention , and all intervention patients were provided with counseling regarding fall prevention and home safety . Outcomes and Measurements The primary study outcome was",
"Background and purpose Few economic or quality -of-life studies have investigated the long-term consequences of fragility fractures . This prospect i ve observational data collection study assessed the cost and quality of life related to hip , vertebral , and wrist fracture 13–18 months after the fracture , based on 684 patients surviving 18 months after fracture . Patients and methods Data regarding re source use and quality of life related to fractures was collected using question naires at 7 research centers in Sweden . Information was collected using patient records , register sources , and by asking the patient . Quality of life was estimated using the EQ-5D question naire . Direct and indirect costs were estimated from a societal st and point . Results The mean fracture-related cost 13–18 months after a hip , vertebral , or wrist fracture were estimated to be € 2,422 , € 3,628 , and € 316 , respectively . Between 12 and 18 months after hip , vertebral , and wrist fracture , utility increased by 0.03 , 0.05 , and 0.02 , respectively . Compared to prefracture levels , the mean loss in quality of life between 13 and 18 months after fracture was estimated to be 0.05 , 0.11 , and 0.005 for hip , vertebral , and wrist fracture . Interpretation The sample of vertebral fracture patients was fairly small and included a high proportion of fractures leading to hospitalization , but the results indicate higher long-term costs and greater loss in quality of life related to vertebral fracture than previously believed",
"Although vertebral fractures are common among older women , little is known about associations with pain and disability . In this prospect i ve study , fractures which occurred after the initial radiograph were strong predictors of back pain and disability at the end of followup , with odds ratios ( OR ) of approximately 4 - 5 . Other , independently significant predictors were self-reported history of ( 1 ) disk disease ( OR = 3 - 9 ) , ( 2 ) traumatic back injury ( OR = 4 - 7 ) , and ( 3 ) spinal arthritis ( OR = 3 - 6 ) . In longitudinal analyses , new fractures were associated ( OR = 6.4 ; 95 % CI = 2.6 , 15.6 ) with increases in back pain frequency ( relative to pre-fracture levels ) . The association with prevalent fractures was weaker , and not significant ( OR = 1.7 ; 95 % CI = 0.5 , 5.6 ) . The pain frequency index increased approximately 3-fold , relative to pre-fracture levels . At the end of followup ( mean = 3.5 years ) , the index was still two times greater than baseline . We conclude that associations with back pain and disability are greater in magnitude for new vertebral fractures than for prevalent fractures",
"BACKGROUND Distal radius fracture is recognized as an osteoporosis-related fracture in aged population . If another osteoporosis-related fracture occurs in a short period , it represents a prolonged hospitalization and a considerable economic burden to the society . We evaluated the relationship between distal radius fracture and subsequent hip fracture within 1 year , especially in the critical time and age . METHODS We identified newly diagnosed distal radius fracture patients in 2000 to 2006 as an exposed cohort ( N = 9,986 ) . A comparison cohort ( N = 81,227 ) was r and omly selected from patients without distal radius fracture in the same year of exposed cohort . The subjects were followed up for 1 year since the recruited date . We compared the sociodemographic factors between two cohorts . Furthermore , the time interval following the previous distal radial fracture and the incidence of subsequent hip fracture was studied in detail . RESULTS The incidence of hip fracture within 1 year increased with age in both cohorts . The risk was 5.67 times ( 84.6 vs. 14.9 per 10,000 person-years ) greater in the distal radial fracture cohort than in the comparison cohort . The multivariate Cox proportional hazard regression analyses showed the hazard ratios of hip fracture in relation to distal radial fracture was 3.45 ( 95 % confidence interval = 2.59–4.61 ) . The highest incidence was within the first month after distal radial fracture , 17-fold higher than the comparison cohort ( 17.9 vs. 1.05 per 10,000 ) . Among comorbidities , age > 60 years was also a significant factor associated with hip fracture ( hazard ratio = 8.67 , 95 % confidence interval = 4.51–16.7 ) . CONCLUSIONS Patients with distal radius fracture and age > 60 years will significantly increase the incidence of subsequent hip fracture , especially within the first month . LEVEL OF EVIDENCE Prognostic/epidemiologic study , level II",
"Background : Hip fracture patients are reported to have an increased mortality rate compared to the general population . In order to be able to reduce the morbidity and mortality after a hip fracture , our efforts to identify the patients at risk already upon admission to the hospital need to be increased . For such a risk assessment , robust , vali date d , and reproducible criteria are m and atory . Objective : To determine preoperative factors associated with mortality and to evaluate the combined use of the American Society of Anesthesiologists ( ASA ) and the Short Portable Mental Status Question naire ( SPMSQ ) to identify patients with an increased mortality rate and to create a predictive model to assess the mortality risk after hip fracture surgery . Methods : A total of 1,944 consecutive patients aged 66 years or older admitted for a hip fracture were included in a prospect i ve cohort study with a 24-month follow-up . The patients were assessed with regard to gender , age , type of hip fracture , smoking habits , comorbidities , general physical health according to the ASA classification , and cognitive function according to the SPMSQ . A higher ASA score indicates an increasingly severe systemic disease and a lower SPMSQ score indicates an increasingly severe cognitive dysfunction . We used Cox proportional hazard models and classification trees to identify the factors associated with mortality . The predictive model was created based on factors that were significantly associated with death and all readily accessible upon admission . Results : The mortality rate during the acute hospitalization period was 4 % , at 4 months 16 % , and at 24 months 38 % . The most prominent factors associated with mortality were high ASA scores , low SPMSQ scores , high age and male gender . The SPMSQ score provided additional information about the survival time , compared to when the ASA score was used alone . Conclusion : The combined use of the ASA classification for assessing physical health and the SPMSQ for assessing cognitive function effectively identified hip fracture patients with an increased mortality rate . We present a predictive model including age , gender , ASA , and SPMSQ that can be used to assess the mortality risk after hip fracture surgery"
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Detrusor overactivity ( DO ) is a common clinical problem having profound effects on the quality of life ( QOL ) of women . With the use of meshes in the antiincontinence surgery , a new onset of DO , de novo DO has become an important issue in postoperative QOL of women . A systematic review of English language literature was conducted from Pubmed and publications of the last 7 years were analyzed and presented in this review . Multiple pathological events in the urothelium , sub-urothelium and possibly in the detrusor muscle seem to underlie the pathophysiology of DO . A variety of approaches , from life style modification to minimal-invasive surgery are available to treat DO and it is the responsibility of the physician to properly select and apply these modalities with the ultimate aim in improving the QOL of the patients . It is imperative to know the various pathophysiological processes that underlie the causation of DO to select proper management approach
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"Data regarding the prevalence and urodynamic characteristics of involuntary detrusor contractions ( IDC ) in various clinical setting s , as well as in neurologically intact vs. neurologically impaired patients , are scarce . The aim of our study was to evaluate whether the urodynamic characteristics of IDC differ in various clinical categories . One hundred eleven consecutive neurologically intact patients and 21 consecutive neurologically impaired patients , referred for evaluation of persistent irritative voiding symptoms , were prospect ively enrolled . All patients were presumed by history to have IDC , and underwent detailed clinical and urodynamic evaluation . Based on clinical evaluation , patients were placed into one of four categories according to the main presenting symptoms and the existence of neurological insult : 1 ) frequency/urgency ; 2 ) urge incontinence ; 3 ) mixed stress incontinence and irritative symptoms ; and 4 ) neurogenic bladder . IDC was defined by detrusor pressure of > or = 15 cm H2O whether or not the patient perceived the contraction ; or urodynamic characteristics of IDC were analyzed and compared between the four groups . IDC were observed in all of the neurologically impaired patients , compared with 76 % of the neurologically intact patients ( P amplitude of IDC and subjective report of urgency . All clinical categories demonstrated IDC at approximately 80 % of cystometric capacity . Eighty-one percent of the neurologically impaired patients , compared with 97 % of the neurologically intact patients , were aware of the IDC at the time of urodynamics ( P ability to abort the IDC was significantly higher among continent patients with frequency/urgency ( 77 % ) compared with urge incontinent patients ( 46 % ) and neurologically impaired patients ( 38 % ) . In conclusion , when evaluating detrusor overactivity , the characteristics of the IDC are not distinct enough to aid in differential diagnosis . However , the ability to abort IDC and stop incontinent flow may have prognostic implication s , especially for the response to behavior modification , biofeedback , and pelvic floor exercise",
"Objective Ambulatory monitoring continues to gain acceptance and increasing clinical application . There remains , however , a sparsity of published data from asymptomatic Volunteers , particulary women . Our aim was , by study of such a group , to establish normal ranges for cystometric variables on ambulatory monitoring",
"Introduction and hypothesisWe assessed fesoterodine efficacy and tolerability in women with overactive bladder ( OAB ) . Methods This post hoc analysis of pooled data from two clinical trials included 1,548 women with OAB r and omized to placebo , fesoterodine 4 or 8 mg , or tolterodine extended release ( ER ) 4 mg ( in 1 trial ) for 12 weeks . Subjects completed 3-day bladder diaries at baseline and weeks 2 and 12 and rated Treatment Response at weeks 2 and 12 . Results By weeks 2 and 12 , all active-treatment groups showed significant improvements in all five bladder diary variables assessed and greater Treatment Response rates vs placebo . Fesoterodine 8 mg was significantly more efficacious than fesoterodine 4 mg and tolterodine ER in improving urgency urinary incontinence episodes and continent days per week . The most common adverse events were dry mouth and constipation , which were predominately mild or moderate . Conclusions Fesoterodine is efficacious and well tolerated in women with OAB",
"Our objectives were to ascertain the tolerability and efficacy of trospium chloride in doses of 20 mg twice daily for long-term therapy ( 52 weeks ) in patients with urge syndrome . The trial comprised a total of 358 patients with urge syndrome or urge incontinence . After r and omisation in the ratio of 3:1 , participants were treated continuously for 52 weeks with either trospium chloride ( 20 mg twice daily ) or oxybutynin ( 5 mg twice daily ) . At intervals of 4–8 weeks , patients were physically examined with measurements of blood pressure and pulse rate , were question ed about any adverse events , checked for compliance and underwent relevant laboratory tests . As an additional safety measure , an ECG was made at 26 and 52 weeks . Urodynamic measurements were performed at the beginning , and at 26 and 52 weeks to determine the maximal cystometric bladder capacity . Among others things , the frequencies of micturition , incontinence and number of urgency events were recorded in patient diary protocol s in weeks 0 , 2 , 26 and 52 . The evaluation of vital parameters , laboratory results and ECGs did not show any relevant changes attributable to the action of the anticholinergics . Analysis of the micturition diary clearly indicated a reduction of the micturition frequency , incontinence frequency , and a reduction of the number of urgencies in both treatment groups . Mean maximum cystometric bladder capacity increased during treatment with trospium chloride by 92 ml after 26 weeks and 115 ml after 52 weeks ( P=0.001 ) . Further comparison with oxybutynin did not reveal any statistically significant differences in urodynamic variables between the drugs . Adverse events occurred in 64.8 % of the patients treated with trospium chloride and 76.7 % of those treated with oxybutynin . The main symptom encountered in both treatment group was dryness of the mouth . For patients on trospium chloride , the estimated risk of an unexpected adverse event was 0.027 per patient per week for all adverse events and 0.009 for dryness of the mouth , result ing in a considerably lower risk during treatment given with trospium chloride than with oxybutynin ( 0.045 and 0.021 , respectively ) . An overall assessment for each of the drugs reveals a comparable efficacy level and a better benefit-risk ratio for trospium chloride than for oxybutynin due to better tolerability ",
"OBJECTIVES To compare the efficacy and safety of an oxybutynin transdermal delivery system ( OXY-TDS ) and oral , long-acting tolterodine ( TOL-LA ) with placebo in previously treated patients with urge or mixed urinary incontinence . METHODS After withdrawal of their current antimuscarinic therapy , 361 adult patients were r and omized to 12 weeks of double-blind , double-dummy treatment with twice weekly OXY-TDS 3.9 mg/day , daily TOL-LA 4 mg , or placebo . Evaluations included change from baseline in patient urinary diary symptoms , incontinence-specific quality of life , and safety . RESULTS OXY-TDS 3.9 mg/day and TOL-LA 4 mg/day significantly reduced the number of daily incontinence episodes ( median change -3 OXY-TDS and -3 TOL-LA versus -2 placebo ; P average void volume ( median change 24 and 29 mL versus 5.5 mL , P quality of life ( incontinence impact question naire [ IIQ ] total score , P Urogenital Distress Inventory Irritative Symptom subscale , P placebo . The most common adverse event for OXY-TDS was localized application site pruritus ( 14 % versus 4 % placebo ) accompanied by a low incidence of systemic side effects ( eg , dry mouth 4.1 % ) . Anticholinergic adverse events occurred with greatest frequency during TOL-LA treatment ( dry mouth 7.3 % versus 1.7 % placebo , P OXY-TDS and TOL-LA are effective and comparable treatments for patients with urge and mixed incontinence . OXY-TDS improves systemic safety with regard to anticholinergic side effects . Local skin irritation occurs in some OXY-TDS patients",
"The objective of the study was to obtain a prospect i ve assessment of the efficacy and the complications associated with the use of tension-free vaginal tape ( TVT ) for the management of urodynamic stress incontinence at 5- and 7-year follow-up . Sixty-five female patients with stage I cystocele or less who have been operated with TVT procedure for management of urodynamic stress incontinence have been included in the study . At 5-year follow-up , the objective cure rate was 83 % and failure rate 9.4 % . At 7-year follow-up , the objective cure rate was 80 % and the failure rate 13.5 % . De novo detrusor overactivity was seen in 9.4 % and 11.4 % of patients at 5- and 7-year follow-up , respectively . TVT operation is an effective and safe minimally invasive procedure for the management of urodynamic stress incontinence in women without significant cystocele in the long-term follow-up . The 10- and 20-year results are awaited",
"AIMS The objective of this study was to evaluate the effect of posterior tibial nerve stimulation ( PTNS ) for treatment of urge incontinence . METHODS In a prospect i ve multicentre study , 35 patients with complaints of urge incontinence underwent 12 weekly sessions of PTNS at one of five sites in the Netherl and s and one site in Italy . Frequency/volume charts and I-QoL and SF-36 question naires were completed at 0 and 12 weeks . Success was analysed by using subjective and objective criteria . Overall subjective success was defined as the willingness to continue treatment , whereas objective success was defined as a significant decrease ( to total number of leakage episodes . RESULTS Twenty-two patients ( 63 % ) reported a subjective success . Twenty-four patients ( 70 % ) showed a 50 % or greater reduction in total number of leakage episodes . Sixteen ( 46 % ) of these- patients were completely cured ( i.e. , no leakage episodes ) after 12 sessions . Quality of life parameters improved significantly . CONCLUSIONS We conclude that posterior tibial nerve stimulation is an effective , minimally invasive option for treatment of patients with complaints of urge incontinence , as improvement was seen in subjective as well as objective parameters",
"OBJECTIVE We compared the efficacy of bladder training , pelvic muscle exercise with biofeedback-assisted instruction , and combination therapy , on urinary incontinence in women . The primary hypothesis was that combination therapy would be the most effective in reducing incontinent episodes . STUDY DESIGN A r and omized clinical trial with three treatment groups was conducted in gynecologic practice s at two university medical centers . Two hundred and four women diagnosed with genuine stress incontinence ( n = 145 ) and /or detrusor instability ( n = 59 ) received a 12-week intervention program ( 6 weekly office visits and 6 weeks of mail/telephone contact ) with immediate and 3-month follow-up . Outcome variables included number of incontinent episodes , quality of life , perceived improvement , and satisfaction . Data analyses consisted of analysis of covariance using baseline values as covariates and chi2 tests . RESULTS The combination therapy group had significantly fewer incontinent episodes , better quality of life , and greater treatment satisfaction immediately after treatment . No differences among groups were observed 3 months later . Women with genuine stress incontinence had greater improvement in life impact , and those with detrusor instability had less symptom distress at the immediate follow-up ; otherwise , no differences were noted by diagnosis , incontinence severity , or treatment site . CONCLUSIONS Combination therapy had the greatest immediate efficacy in the management of female urinary incontinence regardless of urodynamic diagnosis . However , each of the 3 interventions had similar effects 3 months after treatment . Results suggest that the specific treatment may not be as important as having a structured intervention program with education , counseling , and frequent patient contact",
"BACKGROUND Women with urge urinary incontinence are commonly treated with antimuscarinic medications , but many discontinue therapy . OBJECTIVE To determine whether combining antimuscarinic drug therapy with supervised behavioral training , compared with drug therapy alone , improves the ability of women with urge incontinence to achieve clinical ly important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy . DESIGN 2-stage , multicenter , r and omized clinical trial conducted from July 2004 to January 2006 . SETTING 9 university-affiliated outpatient clinics . PATIENTS 307 women with urge-predominant incontinence . INTERVENTION 10 weeks of open-label , extended-release tolterodine alone ( n = 153 ) or combined with behavioral training ( n = 154 ) , followed by discontinuation of therapy and follow-up at 8 months . MEASUREMENTS The primary outcome , measured at 8 months , was no receipt of drugs or other therapy for urge incontinence and a 70 % or greater reduction in frequency of incontinence episodes . Secondary outcomes were reduction in incontinence , self-reported satisfaction and improvement , and scores on vali date d question naires measuring symptom distress and bother and health-related quality of life . Study staff who performed outcome evaluations , but not participants and interventionists , were blinded to group assignment . RESULTS 237 participants completed the trial . According to life-table estimates , the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups ( 41 % in both groups ; difference , 0 percentage points [ 95 % CI , -12 to 12 percentage points ] ) . A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70 % or greater reduction in incontinence at 10 weeks ( 69 % vs. 58 % ; difference , 11 percentage points [ CI , -0.3 to 22.1 percentage points ] ) . Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Question naire ( both P patient satisfaction and perceived improvement but not health-related quality of life . Adverse events were uncommon ( 12 events in 6 participants [ 3 in each group ] ) . LIMITATIONS Behavioral therapy components ( daily bladder diary and recommendations for fluid management ) in the group receiving drug therapy alone may have attenuated between-group differences . Assigned treatment was completed by 68 % of participants , whereas 8-month outcome status was assessed on 77 % . CONCLUSION The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence . Combination therapy has a beneficial effect on patient satisfaction , perceived improvement , and reduction of other bladder symptoms",
"OBJECTIVE To compare two new generation antimuscarinics at their recommended doses for treatment of overactive bladder syndrome ( OAB ) . METHODS A prospect i ve , double blind , double-dummy , two-arm , parallel-group , 12-week study was conducted to compare the efficacy and safety of solifenacin 5 or 10 mg and tolterodine extended release ( ER ) 4 mg once daily in OAB patients . After 4 weeks of treatment patients had the option to request a dose increase but were dummied throughout as approved product labelling only allowed an increase for those on solifenacin . RESULTS Solifenacin , with a flexible dosing regimen , showed greater efficacy to tolterodine in decreasing urgency episodes , incontinence , urge incontinence and pad usage and increasing the volume voided per micturition . More solifenacin treated patients became continent and reported improvements in perception of bladder condition assessment s. The majority of side effects were mild to moderate in nature , and discontinuations were comparable and low in both groups . CONCLUSIONS Solifenacin , with a flexible dosing regimen , was found to be superior to tolterodine ER with respect to the majority of the efficacy variables",
"Objectives : To compare the effectiveness of sacral root neuromodulation with that of conservative management in ameliorating symptoms of refractory urinary urge incontinence and enhancing quality of life , to assess the objective response to neuromodulation as revealed by urodynamic testing , and to delineate the long – term outcomes of neuromodulation . Methods : Forty – four patients with refractory urge incontinence were r and omized to undergo neuromodulation with an implantable impulse generator ( n = 21 ) or to continue their prior conservative management ( n = 23 ) . At 6 months the control group was eligible for crossover to implant . Patient evaluation included voiding diaries , quality of life question naires , urodynamic testing , and documentation of adverse events . Long – term follow – up evaluations were conducted at 6–month intervals up to 36 months . Results : At 6 months mean leakage episodes , leakage severity and pad usage in the implant group were significantly lower by 88 % ( p Improvements in leakage episodes and pad usage of ≥90 % were attained by 75 and 85 % of the implant group , respectively , but none of the control group . One third of implant patients , but none of the control patients , achieved ≥50 % improvement in leakage severity . Over half of the implant patients ( 56 % ) were completely dry compared with 1 control patient ( 4 % ) . Implant patients , but not control patients , exhibited significant improvement with respect to two quality of life measures . Neuromodulation result ed in increases of 220 % ( p 0.013 ) , respectively , in urodynamically assessed bladder volume at first contraction and maximum fill . At 36 months the actuarial rate of treatment failure was 32.4 % ( 95 % CI , 17.0–56.0 % ) . Adverse events most frequently involved pain at the implant site , and the incidence of serious complications was low . Conclusions : Neuromodulation is markedly more effective than conservative management in alleviating symptoms of refractory urge incontinence . Quality of life and urodynamic function are also improved by neuromodulation . The effects of neuromodulation are long – lasting , and associated morbidity is low"
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BACKGROUND Pharmacists may improve the clinical management of major risk factors for cardiovascular disease ( CVD ) prevention . A systematic review was conducted to determine the impact of pharmacist care on the management of CVD risk factors among out patients . METHODS The MEDLINE , EMBASE , CINAHL , and Cochrane Central Register of Controlled Trials data bases were search ed for r and omized controlled trials that involved pharmacist care interventions among out patients with CVD risk factors . Two review ers independently abstract ed data and classified pharmacists ' interventions . Mean changes in blood pressure , total cholesterol , low-density lipoprotein cholesterol , and proportion of smokers were estimated using r and om effects models . RESULTS Thirty r and omized controlled trials ( 11,765 patients ) were identified . Pharmacist interventions exclusively conducted by a pharmacist or implemented in collaboration with physicians or nurses included patient educational interventions , patient-reminder systems , measurement of CVD risk factors , medication management and feedback to physician , or educational intervention to health care professionals . Pharmacist care was associated with significant reductions in systolic/diastolic blood pressure ( 19 studies [ 10,479 patients ] ; -8.1 mm Hg [ 95 % confidence interval { CI } , -10.2 to -5.9]/-3.8 mm Hg [ 95 % CI,-5.3 to -2.3 ] ) ; total cholesterol ( 9 studies [ 1121 patients ] ; -17.4 mg/L [ 95 % CI,-25.5 to -9.2 ] ) , low-density lipoprotein cholesterol ( 7 studies [ 924 patients ] ; -13.4 mg/L [ 95 % CI,-23.0 to -3.8 ] ) , and a reduction in the risk of smoking ( 2 studies [ 196 patients ] ; relative risk , 0.77 [ 95 % CI , 0.67 to 0.89 ] ) . While most studies tended to favor pharmacist care compared with usual care , a substantial heterogeneity was observed . CONCLUSION Pharmacist-directed care or in collaboration with physicians or nurses improve the management of major CVD risk factors in out patients
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"OBJECTIVE : To evaluate the effectiveness of a community pharmacist-based home blood pressure ( BP ) monitoring program . DESIGN : Trial of a high-intensity ( HI ) versus low-intensity ( LI ) intervention r and omized in 12 community pharmacies . The HI intervention comprised 4 face-to-face visits with a trained pharmacist . Pharmacists provided patient-specific education about hypertension . Following the first and third visits , patients were provided with a home BP monitoring device and instructed to measure their BP at least once daily for the next month . Home BP readings were used by the pharmacists to develop treatment recommendations for the patient ’s physician . Recommendations were discussed with the physician and , if approved , implemented by the pharmacist . In the LI intervention , pharmacists measured patients BP in the pharmacy and referred them to their physician for evaluation . PARTICIPANTS : Patients with uncontrolled BP at baseline . MEASUREMENTS : The main outcomes were the differences in systolic and diastolic BP ( SBP and DBP ) from baseline to follow-up between the HI and LI patients . RESULTS : The study enrolled 125 patients , 64 in the HI and 61 in the LI group . From baseline , SBP declined 13.4 mmHg in the HI group and 9.0 mmHg in the LI group . At the final visit , the difference in SBP/DBP change between the HI and LI group was −4.5/−3.2 mmHg ( P=.12 for SBP and P=.03 for DBP ) . CONCLUSIONS : The HI intervention achieved a lower DBP and this model could be a strategy for patients with hypertension",
"OBJECTIVE To compare the effectiveness of an evidence -based , systematic approach to hypertension care involving comanagement of patients by primary care physicians and clinical pharmacists versus usual care in reducing blood pressure in patients with uncontrolled hypertension . METHODS Patients in a staff model medical group with uncontrolled hypertension were r and omized to either a usual care ( UC ) or a physician-pharmacist comanagement ( PPCM ) group . All physicians in the study received both group and individual education and participated in the development of an evidence -based hypertension treatment algorithm . Physicians were then given the names of their patients whose medical records documented elevated blood pressures ( defined as systolic > or = 140 mm Hg and /or diastolic > or = 90 mm Hg for patients aged or = 160 mm Hg and /or diastolic > or = 90 mm Hg for those aged > or = 65 yrs ) . Patients r and omized to the UC group were managed by primary care physicians alone . Those r and omized to the PPCM group were comanaged by their primary care physician and a clinical pharmacist , who provided patient education , made treatment recommendations , and provided follow-up . Blood pressure measurements , antihypertensive drugs , and visit costs/patient were obtained from medical records . RESULTS One hundred ninety-seven patients with uncontrolled hypertension participated in the study . Both PPCM and UC groups experienced significant reductions in blood pressure ( systolic -22 and -11 mm Hg , respectively , p reduction in systolic blood pressure was greater in the PPCM group after adjusting for differences in baseline blood pressure between the groups ( p blood pressure control in the PPCM than in the UC group ( 60 % vs 43 % , p = 0.02 ) . Average provider visit costs/patient were higher in the UC than the PPCM group ( $ 195 vs $ 160 , p = 0.02 ) . CONCLUSIONS An evidence -based , systematic approach using physician-pharmacist comanagement for patients with uncontrolled hypertension result ed in improved blood pressure control and reduced average visit costs/patient",
"OBJECTIVES To identify patients at risk for coronary artery disease ( CAD ) through a search of a community pharmacy 's prescription data base , to screen and identify patients with elevated cholesterol and at risk for CAD , to enroll patients in a pharmacist-directed lipid management program , and to evaluate selected clinical and humanistic outcomes . DESIGN R and omized , pretest-posttest control groups . SETTING Independent community pharmacy in a suburban metropolitan area . PATIENTS 51 patients who were not at National Cholesterol Education Program low-density lipoprotein cholesterol ( LDL-C ) or defined triglyceride goals and who met inclusion criteria . INTERVENTION Pharmacist-directed lipid management program . MAIN OUTCOME MEASURES Clinical outcome measures included total cholesterol , LDL-C , high-density lipoprotein cholesterol ( HDL-C ) , and triglyceride levels ; achievement of LDL-C goal ; and risk factor prediction scores . Humanistic outcome measures included patient satisfaction with pharmaceutical care and patient knowledge of hyperlipidemia . RESULTS LDL-C was decreased in the pharmacist intervention group ( n = 25 ) , compared with an increase in the control group at study end . HDL-C levels increased and triglyceride levels decreased in both groups . Of treatment group patients , 32 % achieved their cholesterol goals , compared with 15 % of control group patients . Risk factor prediction scores improved in the treatment group and worsened in the control group . The treatment group 's hyperlipidemia knowledge scores improved significantly from pretest to posttest . Both treatment and control group patient satisfaction scores for the pharmacist investigator were favorable at study end . CONCLUSION Both treatment and control patients benefited from participating in this study . Patients enrolled in the lipid management program made greater improvements in their knowledge of hyperlipidemia , risk factor scores , and cholesterol levels",
"BACKGROUND Pharmaceutical care programs may be an option to improve blood pressure ( BP ) control in patients with uncontrolled hypertension . The aim of this study was to evaluate the efficacy of pharmaceutical care programs in treating patients with resistant hypertension . METHODS In a double-blind r and omized clinical trial , 71 patients with uncontrolled BP were enrolled in a pharmaceutical care program or in a control group and underwent a series of cognitive tests . The primary outcome was change in ambulatory BP ( ABP ) between the baseline evaluation and the final visit 6 months later . The secondary outcomes were the frequency of drug-related problems and adherence as determined by plasma levels of hydrochlorothiazide . RESULTS The delta-values between the intervention and control groups for ABP in the different daily periods , with the corresponding 95 % confidence limits , adjusted for age and baseline BP were : 3 ( -1 to 5 ) , 2 ( -2 to 4 ) , and 5 ( -1 to 6 ) mm Hg for 24 h , daily and nightly systolic BP , respectively . The corresponding values for diastolic BP were 1 ( -1 to 3 ) , 0 ( -2 to 2 ) , and 3 ( -1 to 4 ) mm Hg , respectively . Hydrochlorothiazide was detected in the plasma in 21 of 27 patients in the intervention group that attended to all appointments and 24 of 30 patients in the control group ( P = .904 ) . CONCLUSIONS The pharmaceutical care program tested in this trial was feasible and showed a trend for better BP control in patients with uncontrolled hypertension",
"CONTEXT Poor medication adherence diminishes the health benefits of pharmacotherapies . Elderly patients with coronary risk factors frequently require treatment with multiple medications , placing them at increased risk for nonadherence . OBJECTIVE To test the efficacy of a comprehensive pharmacy care program to improve medication adherence and its associated effects on blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) . DESIGN , SETTING , AND PATIENTS A multiphase , prospect i ve study with an observational phase and a r and omized controlled trial conducted at the Walter Reed Army Medical Center of 200 community-based patients aged 65 years or older taking at least 4 chronic medications . The study was conducted from June 2004 to August 2006 . INTERVENTION After a 2-month run-in phase ( measurement of baseline adherence , BP , and LDL-C ) , patients entered a 6-month intervention phase ( st and ardized medication education , regular follow-up by pharmacists , and medications dispensed in time-specific packs ) . Following the intervention phase , patients were r and omized to continued pharmacy care vs usual care for an additional 6 months . MAIN OUTCOME MEASURES Primary end point of the observation phase was change in the proportion of pills taken vs baseline ; secondary end points were the associated changes in BP and LDL-C. Primary end point of the r and omization phase was the between-group comparison of medication persistence . RESULTS A total of 200 elderly patients ( 77.1 % men ; mean [ SD ] age , 78 [ 8.3 ] years ) , taking a mean ( SD ) of 9 ( 3 ) chronic medications were enrolled . Coronary risk factors included drug-treated hypertension in 184 patients ( 91.5 % ) and drug-treated hyperlipidemia in 162 ( 80.6 % ) . Mean ( SD ) baseline medication adherence was 61.2 % ( 13.5 % ) . After 6 months of intervention , medication adherence increased to 96.9 % ( 5.2 % ; P systolic BP ( 133.2 [ 14.9 ] to 129.9 [ 16.0 ] mm Hg ; P = .02 ) and LDL-C ( 91.7 [ 26.1 ] to 86.8 [ 23.4 ] mg/dL ; P = .001 ) . Six months after r and omization , the persistence of medication adherence decreased to 69.1 % ( 16.4 % ) among those patients assigned to usual care , whereas it was sustained at 95.5 % ( 7.7 % ) in pharmacy care ( P reductions in systolic BP in the pharmacy care group ( -6.9 mm Hg ; 95 % CI , -10.7 to -3.1 mm Hg ) vs the usual care group ( -1.0 mm Hg ; 95 % CI , -5.9 to 3.9 mm Hg ; P = .04 ) , but no significant between-group differences in LDL-C levels or reductions . CONCLUSIONS A pharmacy care program led to increases in medication adherence , medication persistence , and clinical ly meaningful reductions in BP , whereas discontinuation of the program was associated with decreased medication adherence and persistence . TRIAL REGISTRATION clinical trials.gov Identifier :",
"BACKGROUND Studies have demonstrated that blood pressure ( BP ) control can be improved when clinical pharmacists assist with patient management . The objective of this study was to evaluate if a physician and pharmacist collaborative model in community-based medical offices could improve BP control . METHODS This was a prospect i ve , cluster r and omized , controlled clinical trial with clinics r and omized to a control group ( n = 3 ) or to an intervention group ( n = 3 ) . The study enrolled 402 patients ( mean age , 58.3 years ) with uncontrolled hypertension . Clinical pharmacists made drug therapy recommendations to physicians based on national guidelines . Research nurses performed BP measurements and 24-hour BP monitoring . RESULTS The mean ( SD ) guideline adherence scores increased from 49.4 ( 19.3 ) at baseline to 53.4 ( 18.1 ) at 6 months ( 8.1 % increase ) in the control group and from 40.4 ( 22.6 ) at baseline to 62.8 ( 13.5 ) at 6 months ( 55.4 % increase ) in the intervention group ( P = .09 for adjusted between-group comparison ) . The mean BP decreased 6.8/4.5 mm Hg in the control group and 20.7/9.7 mm Hg in the intervention group ( P systolic BP was -12.0 ( 95 % confidence interval [ CI ] , -24.0 to 0.0 ) mm Hg , while the adjusted difference in diastolic BP was -1.8 ( 95 % CI , -11.9 to 8.3 ) mm Hg . The 24-hour BP levels showed similar effect sizes . Blood pressure was controlled in 29.9 % of patients in the control group and in 63.9 % of patients in the intervention group ( adjusted odds ratio , 3.2 ; 95 % CI , 2.0 - 5.1 ; P A physician and pharmacist collaborative intervention achieved significantly better mean BP and overall BP control rates compared with a control group . Additional research should be conducted to evaluate efficient strategies to implement team-based chronic disease management . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00201019",
"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 ",
"ABSTRACT OBJECTIVE Evaluate the effectiveness of collaborative management of hypertension by primary care-pharmacist teams in community-based clinics . STUDY DESIGN A 12-month prospect i ve , single-blind , r and omized , controlled trial in the Providence Primary Care Research Network of patients with hypertension and uncontrolled blood pressure . METHODS As compared to usual primary care , intervention consisted of pharmacy practitioners participating in the active management of hypertension in the primary care office according to established collaborative treatment protocol s. At baseline , there was no significant difference in blood pressure between groups . Primary outcome measures were the differences in mean systolic and diastolic blood pressures between arms at study end . Secondary measures included blood pressure goal attainment ( RESULTS A total of 463 subjects were enrolled ( n = 233 control , n = 230 intervention ) . Subjects receiving the intervention achieved significantly lower systolic ( p = 0.007 ) and diastolic ( p = 0.002 ) blood pressures compared to control ( 137/75 mmHg vs. 143/78 mmHg ) . In addition , 62 % of intervention subjects achieved target blood pressure compared to 44 % of control subjects ( p = 0.003 ) . The intervention group received more total office visits ( 7.2 vs. 4.9 , p physician visits ( 3.2 vs. 4.7 , p antihypertensive medications ( 2.7 vs. 2.4 , p = 0.02 ) , but did not take more antihypertensive pills per day ( 2.4 vs. 2.5 , p = 0.87 ) . There were minimal differences between groups in hypertension-related knowledge , medication adherence , quality of life , or satisfaction . CONCLUSIONS Patients r and omized to collaborative primary care-pharmacist hypertension management achieved significantly better blood pressure control compared to usual care with no difference in quality of life or satisfaction",
"BACKGROUND Blood pressure ( BP ) control in patients with diabetes mellitus is difficult to achieve and current patterns are suboptimal . Given increasing problems with access to primary care physicians , community pharmacists and nurses are well positioned to identify and observe these patients . This study aim ed to determine the efficacy of a community-based multidisciplinary intervention on BP control in patients with diabetes mellitus . METHODS We performed a r and omized controlled trial in 14 community pharmacies in Edmonton , Alberta , Canada , of patients with diabetes who had BPs higher than 130/80 mm Hg on 2 consecutive visits 2 weeks apart . Care from a pharmacist and nurse team included a wallet card with recorded BP measures , cardiovascular risk reduction education and counseling , a hypertension education pamphlet , referral to the patient 's primary care physician for further assessment or management , a 1-page local opinion leader-endorsed evidence summary sent to the physician reinforcing the guideline recommendations for the treatment of hypertension and diabetes , and 4 follow-up visits throughout 6 months . Control-arm patients received a BP wallet card , a pamphlet on diabetes , general diabetes advice , and usual care by their physician . The primary outcome measure was the difference in change in systolic BP between the 2 groups at 6 months . RESULTS A total of 227 eligible patients were r and omized to intervention and control arms between May 5 , 2005 , and September 1 , 2006 . The mean ( SD ) patient age was 64.9 ( 12.1 ) years , 59.9 % were male , and the mean ( SD ) baseline systolic/diastolic BP was 141.2 (13.9)/77.3 ( 8.9 ) mm Hg at baseline . The intervention group had an adjusted mean ( SE ) greater reduction in systolic BP at 6 months of 5.6 ( 2.1 ) mm Hg compared with controls ( P = .008 ) . In the subgroup of patients with a systolic BP greater than 160 mm Hg at baseline , BP was reduced by an adjusted mean ( SE ) of 24.1 ( 1.9 ) mm Hg more in intervention patients than in controls ( P patients who have diabetes and hypertension that are relatively well controlled , a pharmacist and nurse team-based intervention result ed in a clinical ly important improvement in BP . Trial Registration clinical trials.gov Identifier : NCT00374270",
"BACKGROUND Despite clear evidence for the efficacy of lowering cholesterol levels , there is a deficiency in its real-world application . There is a need to explore alternative strategies to address this important public health problem . This study aim ed to determine the effect of a program of community pharmacist intervention on the process of cholesterol risk management in patients at high risk for cardiovascular events . METHODS A r and omized controlled trial conducted in 54 community pharmacies ( 1998 - 2000 ) included patients at high risk for cardiovascular events ( with atherosclerotic disease or diabetes mellitus with another risk factor ) . Patients r and omized to pharmacist intervention received education and a brochure on risk factors , point-of-care cholesterol measurement , referral to their physician , and regular follow-up for 16 weeks . Pharmacists faxed a simple form to the primary care physician identifying risk factors and any suggestions . Usual care patients received the same brochure and general advice only , with minimal follow-up . The primary end point was a composite of performance of a fasting cholesterol panel by the physician or addition or increase in dose of cholesterol-lowering medication . RESULTS The external monitoring committee recommended early study termination owing to benefit . Of the 675 patients enrolled , approximately 40 % were women , and the average age was 64 years . The primary end point was reached in 57 % of intervention patients vs 31 % in usual care ( odds ratio , 3.0 ; 95 % confidence interval , 2.2 - 4.1 ; P community-based intervention program improved the process of cholesterol management in high-risk patients . This program demonstrates the value of community pharmacists working in collaboration with patients and physicians",
"BACKGROUND Adverse drug events and medication errors are threats to quality care . Inpatient studies suggest that a pharmacist may reduce these events , but outpatient studies have not been forthcoming . METHODS We conducted a pooled analysis of 2 r and omized controlled trials to determine the effect of pharmacist intervention on adverse drug events and medication errors . We studied 800 outpatient cases of hypertension stratified into complicated ( n = 535 ) and uncomplicated ( n = 265 ) . Patients in the complicated stratum had heart failure or other cardiovascular complication . Computer programs examined 1-year electronic record data to identify events classified as adverse drug events and preventable or potential adverse drug events . Medication errors included preventable and potential adverse drug events . RESULTS Of the 800 participants ( mean [ SD ] age , 59 [ 10 ] years ) , 484 ( 90.5 % ) and 258 ( 97.4 % ) participants remained in the complicated and uncomplicated strata , respectively , at 12 months . Compared with the control group , the risk of any event was 34 % lower in the intervention group ( risk ratio , 0.66 ; 95 % confidence interval [ CI ] , 0.50 - 0.88 ) , including a lower risk of adverse drug events ( risk ratio , 0.65 ; 95 % CI , 0.47 - 0.90 ) , preventable adverse drug events ( risk ratio , 0.52 ; 95 % CI , 0.25 - 1.09 ) , potential adverse drug events ( risk ratio , 0.70 ; 95 % CI , 0.40 - 1.22 ) , and medication errors ( risk ratio , 0.63 ; 95 % CI , 0.40 - 0.98 ) . CONCLUSIONS This post hoc analysis suggests that pharmacist intervention to improve medication use in out patients with cardiovascular disease decreases the risk of adverse drug events and medication errors . Further studies are needed to confirm this finding",
"STUDY OBJECTIVE To measure the effectiveness of a multifaceted educational intervention to improve ambulatory hypertension control . DESIGN Cluster-r and omized trial . SETTING Academic health system using an ambulatory electronic medical record . SUBJECTS A total of 10,696 patients with a diagnosis of hypertension cared for by 93 primary care providers . INTERVENTION Academic detailing , provision of provider-specific data about hypertension control , provision of educational material s to the provider , and provision of educational and motivational material s to patients . MEASUREMENTS AND MAIN RESULTS The primary outcome was blood pressure control , defined as a blood pressure measurement below 140/90 mm Hg , and was ascertained from electronic medical records over 6 months of follow-up . We determined the adjusted odds ratio for the association between the intervention and the achievement of controlled blood pressure . When we accounted for clustering by provider , this adjusted odds ratio was 1.13 ( 95 % confidence interval 0.87 - 1.47 ) . Adjusted odds ratios were 1.03 ( 95 % confidence interval 0.78 - 1.36 ) in patients whose blood pressure was controlled at baseline and 1.25 ( 95 % confidence interval 0.94 - 1.65 ) in those whose blood pressure was not . These odds ratios were not significantly different ( p=0.11 ) . CONCLUSIONS These results were consistent with no effect or , at best , a relatively modest effect of the intervention among patients with hypertension . Had we not included a concurrent control group , the data would have provided an unduly optimistic view of the effectiveness of the program . The effectiveness of future interventions may be improved by focusing on patients whose blood pressure is uncontrolled at baseline",
"OBJECTIVE : To assess the effect of a physician and pharmacist teamwork approach to uncontrolled hypertension in a medical resident teaching clinic , for patients who failed to meet the recommended goals of the fifth Joint National Commission on Detection , Evaluation and Treatment of High Blood Pressure . HYPOTHESIS : Physician and pharmacist teamwork can improve the rate of meeting national blood pressure goals in patients with previously uncontrolled hypertension . DESIGN : A single-blinded r and omized controlled trial lasting 6 months . SETTING : A primary care outpatient teaching clinic . PATIENTS : A sample of 95 adult hypertensive patients who failed to meet national blood pressure goals based on three consecutive visits over a 6-month period . INTERVENTION : Patients were r and omly assigned to a control arm of st and ard medical care or to an intervention arm in which a physician and pharmacist worked together as a team . MAIN RESULTS : At study completion , the percentage of patients achieving national goals due to intervention was more than double the percentage in the control arm ( 55 % vs 20 % , p Systolic blood pressure declined 23 mm Hg in the intervention arm versus 11 mm Hg in the control arm ( p Diastolic blood pressure declined 14 and 3 mm Hg in the intervention and control arms , respectively ( p Patients who fail to achieve national blood pressure goals under st and ard outpatient medical care may benefit from a program that includes a physician and pharmacist teamwork approach",
"BACKGROUND Poor long-term adherence is an important cause of uncontrolled hypertension . We examined whether monitoring drug adherence with an electronic system improves long-term blood pressure ( BP ) control in hypertensive patients followed by general practitioners ( GPs ) . METHODS A pragmatic cluster r and omised controlled study was conducted over one year in community pharmacists/GPs ' networks r and omly assigned either to usual care ( UC ) where drugs were dispensed as usual , or to intervention ( INT ) group where drug adherence could be monitored with an electronic system ( Medication Event Monitoring System ) . No therapy change was allowed during the first 2 months in both groups . Thereafter , GPs could modify therapy and use electronic monitors freely in the INT group . The primary outcome was a target office BP RESULTS Sixty-eight treated uncontrolled hypertensive patients ( UC : 34 ; INT : 34 ) were enrolled . Over the 12-month period , the likelihood of reaching the target BP was higher in the INT group compared to the UC group ( p target BP vs. 12 % in the UC group ( p reaching the target BP at 4 months ( p monitoring drug adherence in collaboration with pharmacists achieved a better BP control in hypertensive patients , although the impact of monitoring decreased with time",
"OBJECTIVE : To assess the effect of a program that encourages teamwork between physicians and pharmacists on attempts to lower total cholesterol levels and to meet recommended goals proposed by the National Cholesterol Education Program ( NCEP ) . DESIGN A single-blind , r and omized , controlled trial lasting 6 months . SETTING : An ambulatory primary care center . PATIENTS : A sample of 94 patients with total cholesterol levels of 240 mg/dL ( 6.2 mmol/L ) or higher . INTERVENTION : Equal numbers of patients were r and omly assigned to a control arm in which st and ard medical care was received and an intervention arm which implemented close interaction between physicians and pharmacists . MEASUREMENTS AND MAIN RESULTS : Absolute change in total cholesterol levels from baseline values and the percentage of patients who achieved an NCEP goal after 6 months of intervention were determined . The rate of success in achieving NCEP goals in the intervention arm was double the rate in the control arm ( 43 % vs 21 % , p Total cholesterol levels in the intervention arm declined 44 + /- 47 mg/dL ( 1.1 + /- 1.2 mmol/L ) versus 13 + /- 51 mg/dL ( 0.3 + /- 1.3 mmol/L ) in the control arm ( p total cholesterol levels was similar for men and women and did not appear to be altered by age . The effect of intervention was greatest in patients with coronary heart disease ( p of intervention was absent in patients without coronary heart disease and with fewer than two risk factors . CONCLUSIONS : Attempts to lower total cholesterol levels and achieve NCEP goals are likely to be more successful when combined with programs that include teamwork between physicians and pharmacists . Some programs , however , may be more successful for high-risk patients , for whom it is often easier to provide more aggressive therapies . Although altering adverse lipid profiles in lower-risk patients may be difficult , achieving optimal cholesterol levels could have an important impact on preventing movement to higher risk strata",
"BACKGROUND : Inappropriate use of medications is a significant problem in health care today . A possible solution to this problem may be achieved through better control of patients ' drug therapy . OBJECTIVE : To design a pharmaceutical care program for dyslipidemic patients within a community pharmacy setting that provides education in the areas of medication compliance and lifestyle modifications , while emphasizing the importance of achieving cholesterol goals to ensure improvement in quality of life . METHODS : Patients at an outpatient pharmacy volunteered to be surveyed for 16 weeks . Although both the intervention and control groups were surveyed , the r and omly selected intervention group was interviewed more frequently and more comprehensively . Cholesterol , triglycerides , glucose , weight , risk factors , drug-related problems ( DRPs ) , and quality of life were measured via a survey at the onset of the study and continually measured until the study 's conclusion . RESULTS : In the intervention group , 26 DRPs were detected , of which 24 were resolved ; in the control group , 26 DRPs were detected , of which 5 were resolved . When comparing initial and final blood cholesterol levels in the intervention group , the mean decrease was 27.0 ± 41.1 mg/dL ( p = 0.0266 ) ; in the control group , the average blood cholesterol level decreased by a mean of 1.4 ± 37.2 mg/dL ( p = 0.6624 ) . In the intervention group , the triglyceride level decreased an average of 50.5 ± 80.3 mg/dL ( p = 0.0169 ) , while the control group experienced a mean triglyceride level increase of 29.6 ± 118.5 mg/dL ( p = 0.1435 ) . As a result of the intervention , the quality of life in the intervention group was improved . CONCLUSIONS : Short-term pharmaceutical care plans developed in a retail pharmacy within the proper setting may contribute to improved blood lipid values , cardiovascular disease risk factors , and patients ' quality of life",
"This prospect i ve , r and omized , controlled study evaluated the impact of pharmacist-initiated home blood pressure monitoring and intervention on blood pressure control , therapy compliance , and quality of life ( QOL ) . Subjects were 36 patients with uncontrolled stage 1 or 2 hypertension . Eighteen subjects received home blood pressure monitors , a diary , and instructions to measure blood pressure twice every morning . Home measurements were evaluated by a clinical pharmacist by telephone , and the patient 's family physician was contacted with recommendations if mean monthly values were 140/90 mm Hg or higher . Eighteen control patients did not receive home monitors or pharmacist intervention . Office blood pressure measurements and QOL surveys ( SF-36 ) were obtained at baseline and after 6 months . Mean absolute reductions in systolic and diastolic pressures were significantly reduced from baseline in intervention subjects ( 17.0 and 10.5 mm Hg , both p blood pressure values below 140/90 at 6 months compared with controls ( 4 ) . During the study 83.3 % ( 15 ) of intervention subjects had drug therapy changes versus 33 % ( 6 ) of controls ( p Compliance and QOL were not significantly affected . Our data suggest that the combination of pharmacist intervention with home monitoring can improve blood pressure control in patients with uncontrolled hypertension . This may be related to increased modifications of drug regimens",
"OBJECTIVES This study sought to determine if an aggressive , focused low-density lipoprotein cholesterol (LDL-C)-lowering strategy was superior to usual care for coronary heart disease ( CHD ) patients enrolled in health maintenance organization or Veterans Administration setting s. BACKGROUND Statin therapy benefits are well established . No prospect i ve , r and omized studies have tested strategies to optimize these benefits in a \" real-world \" setting . METHODS A total of 2,442 CHD patients with hyperlipidemia were r and omized to either an aggressive treatment arm using atorvastatin or usual care and followed for 51.5 months on average . Atorvastatin-group patients were titrated to LDL-C goals of regular physicians . End point assessment s were complete in 958 atorvastatin-group and 941 usual-care patients . Partial assessment s occurred in 259 patients in the atorvastatin group and 284 patients in the usual care group who did not complete four years of study participation because of adverse events , withdrawn consent , or follow-up loss . The primary efficacy parameter was time to first cardiovascular event . RESULTS A total of 289 ( 23.7 % ) patients in the atorvastatin group compared with 333 ( 27.7 % ) patients in the usual care group experienced a primary outcome ( hazard ratio , 0.83 ; 95 % confidence interval 0.71 to 0.97 , p = 0.02 ) . This reduction in morbidity was largely due to fewer non-fatal myocardial infa rct ions ( 4.3 % vs. 7.7 % , p = 0.0002 ) . Levels of LDL-C were reduced more ( 34.3 % vs. 23.3 % , p National Cholesterol Education Program goals ( LDL-C statin therapy management strategy outperformed usual care in health maintenance organization and Veterans Administration clinic patients with CHD",
"STUDY OBJECTIVE To measure clinical , economic , and humanistic outcomes associated with a pharmacist-managed hypertension clinic compared with physician-managed clinics . DESIGN Prospect i ve , r and omized , comparative study . SETTING Managed care organization . PATIENTS A total of 330 patients with mild-to-moderate essential hypertension . INTERVENTION Hypertension care provided by either the pharmacist-managed hypertension clinic or physician-managed general medical clinics . MEASUREMENTS AND MAIN RESULTS Baseline and 6-month evaluations consisted of systolic and diastolic blood pressure measurements , a short-form health survey , and collection of health care utilization information . After treatment , blood pressure measurements were significantly lower ( p Patient satisfaction was significantly higher in the hypertension clinic group . Total costs for the hypertension clinic group were not different from those of the physician-managed clinic group ( $ 242.46 vs $ 233.20 , p=0.71 ) , but cost : effectiveness ratios were lower in the hypertension clinic group ( $ 27 vs $ 193/mm Hg for systolic blood pressure readings , and $ 48 vs $ 151/mm Hg for diastolic blood pressure readings ) . CONCLUSION In a hypertension clinic , pharmacists can be a cost-effective alternative to physicians in management of patients , and they can improve clinical outcomes and patient satisfaction",
"This was a prospect i ve , cluster r and omized controlled trial in patients with uncontrolled hypertension aged 21 to 85 years ( mean , 61 years ) . Pharmacists made recommendations to physicians for patients in the intervention clinics ( n=101 ) but not patients in the control clinics ( n=78 ) . The mean adjusted difference in systolic blood pressure ( BP ) between the control and intervention groups was 8.7 mm Hg ( 95 % confidence interval [ CI ] , 4.4 - 12.9 ) , while the difference in diastolic BP was 5.4 mm Hg ( CI , 2.8 - 8.0 ) at 9 months . The 24-hour BP levels showed similar effects , with a mean systolic BP level that was 8.8 mm Hg lower ( CI , 5.0 - 12.6 ) and a mean diastolic BP level that was 4.6 mm Hg ( CI , 2.4 - 6.8 ) lower in the intervention group . BP was controlled in 89.1 % of patients in the intervention group and 52.9 % in the control group ( adjusted odds ratio , 8.9 ; CI , 3.8 - 20.7 ; P collaboration achieved significantly better mean BP values and overall BP control rates , primarily by intensification of medication therapy and improving patient adherence",
"BACKGROUND The multidisciplinary approach to managing heart failure has been shown to improve outcomes . The role of a clinical pharmacist in treating heart failure has not been evaluated . METHODS One hundred eighty-one patients with heart failure and left ventricular dysfunction ( ejection fraction were r and omized to an intervention or a control group . Patients in the intervention group received clinical pharmacist evaluation , which included medication evaluation , therapeutic recommendations to the attending physician , patient education , and follow-up telemonitoring . The control group received usual care . The primary end point was combined all-cause mortality and heart failure clinical events . All clinical events were adjudicated by a blinded end point committee . RESULTS Baseline characteristics were similar except for slightly higher age in the intervention group . Median follow-up was 6 months . All-cause mortality and heart failure events were significantly lower in the intervention group compared with the control group ( 4 vs 16 ; P= .005 ) . In addition , patients in the intervention group received higher angiotensin-converting enzyme inhibitor doses as reflected by the median fraction of target reached ( 25th and 75th percentiles ) , 1.0 ( 0.5 and 1 ) and 0.5 ( 0.1875 and 1 ) in the intervention and control groups , respectively ( P use of other vasodilators in angiotensin-converting enzyme inhibitor-intolerant patients was higher in the intervention group ( 75 % vs 26 % ; P= .02 ) . CONCLUSIONS Outcomes in heart failure can be improved with a clinical pharmacist as a member of the multidisciplinary heart failure team . This observation may be due to higher doses of angiotensin-converting enzyme inhibitors and /or closer follow-up",
"OBJECTIVE The study aim ed to investigate the clinical impact of pharmacist-physician co-managed programme on the management of hyperlipidaemia . METHODS The study was a prospect i ve r and omized controlled trial . Adult patients were selected if : ( i ) they were taking one or more lipid-lowering agents with a valid lipid panel before their next follow up ; ( ii ) had a baseline lipid profile within the previous 6 months ; ( iii ) their lipid panel did not reach the targeted low-density lipoprotein-cholesterol ( LDL-C ) goal based on the National Cholesterol Education Programme Adult Treatment Panel III . Pharmacists interviewed patients in the intervention group for 15 - 30 min to provide consultation on the drug regimen and lifestyle modifications . A telephone follow-up every 4 weeks and a follow-up interview on the date of the physician visit were scheduled . Patients in the control group received routine conventional care . The primary outcome measurement was the change in lipid panel between baseline and at the end of study . RESULTS One hundred and eighteen patients were recruited to the study [ 58 patients in intervention group ( mean age 63 + /- 10 years old ) and 60 in control group ( mean age 61 + /- 12 years old ) ] . Starting with similar baseline levels , the end of study LDL-C and total cholesterol levels for the intervention and control groups were LDL-C : 2.80 + /- 0.89 mmol/L and total cholesterol 4.75 + /- 1.08 mmol/L vs. LDL-C : 3.24 + /- 0.78 mmol/L and total cholesterol 5.18 + /- 0.93 mmol/L , respectively . The differences were statistically significant ( P pharmacist-physician co-managed programme for hyperlipidaemic patient was effective in getting more patients to reach their target lipid levels",
"Background : As trained and accessible healthcare professionals , pharmacists are in an ideal position to provide tobacco cessation interventions . Of the 15 studies identified in the literature assessing the effectiveness of tobacco cessation interventions delivered by pharmacists , this is the first r and omized controlled trial conducted in the US of a pharmacist-delivered program for smoking cessation using biochemical confirmation . Objective : To assess the effectiveness on smoking cessation of a face-to-face group program conducted by the pharmacist team compared with a brief st and ard care session delivered by a pharmacist over the telephone . Methods : An open-label , prospect i ve , r and omized , controlled trial was conducted at a Veterans Health Administration , community-based outpatient clinic in the Rocky Mountain region . Participants were r and omly assigned to receive a 3-session face-to-face group program conducted by the pharmacist team or one 5- to 10-minute st and ard care session delivered by the pharmacist team over the telephone . Participants in both groups were offered either immediate-release bupropion or nicotine patch at no cost . The primary outcome of self-reported abstinence was biochemically confirmed by urinary cotinine at 6 months after the quit date . Results : One hundred one smokers were r and omized from October 3 , 2005 , to March 30 , 2007 , with the last 6-month follow-up survey completed on November 6 , 2007 . Analysis of data was completed in December 2007 . Using intent-to-treat procedures , confirmed abstinence rates at the end of 6 months were 28 % in the pharmacist-delivered face-to-face treatment group and 11.8 % in the st and ard care telephone session control group ( p tobacco cessation interventions . Greater utilization of pharmacists in tobacco cessation efforts could have a significant impact on smoking rates , prevention of tobacco-related diseases , and overall improvement in public health across the US",
"This r and omized , controlled trial evaluated the impact of personalized follow-up on compliance rates in high-risk patients receiving combination lipid-lowering therapy over 2 years . A r and om sample of 30 patients 7 - 30 days after cardiac surgery had baseline fasting low-density lipoprotein levels higher than 130 mg/dl . All patients received lovastatin 20 mg/day and colestipol 5 g twice/day . Weekly telephone contact was made with each patient for 12 weeks . Short- and long-term compliance was assessed by pill and packet counts and refill records . Compliance and lipid profile results were significantly better in the intervention group ( p parameters except high-density lipoprotein . However , this effect was not apparent during the first 12 weeks of therapy . Short-term telephone follow-up favorably affected compliance and lipid profile results up to 2 years after start of therapy",
"OBJECTIVES To evaluate the community pharmacist 's capacity to positively influence the results of antihypertensive drug therapy through a pharmaceutical care program and to determine what factors limit the program . DESIGN R and omized , controlled study . SETTING Private pharmacy caring for a semiliterate , rural Portuguese population . PATIENTS R and om sample of 100 patients with a diagnosis of essential hypertension who had been on drug treatment for less than 6 months . Patients were r and omly assigned to an intervention ( n = 50 ) or a control ( n = 50 ) group . INTERVENTION Individualized health promotion by a research pharmacist involving monthly appointments for 6 months to monitor blood pressure ; assess adherence to treatment ; prevent , detect , and resolve drug-related problems ( DRPs ) ; and encourage nonpharmacologic measures for blood pressure control . Control patients received traditional care . MAIN OUTCOME MEASURES Control of blood pressure ; decreases in systolic/diastolic blood pressure ; number of detected , resolved , and prevented DRPs . RESULTS From the initial sample of 100 patients , 41 patients in the intervention group and 41 patients in the control group completed the longitudinal study . After 6 months , prevalence of uncontrolled blood pressure decreased by 77.4 % in the intervention group ( P Systolic blood pressure fell from a mean + /- st and ard deviation of 152 mm Hg + /- 23 mm Hg to 129 + /- 15 mm Hg in intervention patients and 148 + /- 16 mm Hg to 143 + /- 20 mm Hg in control patients ( P DRPs were resolved . About 40 % of potential DRPs were prevented . CONCLUSION In this rural community , a pharmaceutical care program was associated with significant improvements in blood pressure control in hypertensive patients",
"OBJECTIVE To evaluate the adequacy of management of modifiable risk factors ( MRF ) in a group of ischemic stroke out patients and the value of pharmacist intervention in a r and omized controlled study in a tertiary referral hospital . METHODS 160 ischemic stroke out patients from the same catchment area and with the same financial arrangements for healthcare , went through a 6-month equal allocation stratified r and omized study . Routine practice was not altered except for a monthly 1-hour pharmacist-intervention education programme . We evaluated the differences in blood pressure ( BP ) , blood glucose and lipid profiles before and after study . The proportion of patients with adequate management of MRF was studied . RESULTS There were no differences in the demographic characteristics , MRF and medications prescribed throughout the study . Before the study , the proportions of adequate control of BP in the control and intervention groups were 43 % vs. 40 % ( P = 0.64 ) , lipid 27 % vs. 13 % ( P = 0.09 ) and glucose 36 % vs. 21 % ( P = 0.15 ) . At the end of the study , the corresponding proportions were for BP 43 % vs. 83 % ( P = 0.00 ) , lipid 27 % vs. 40 % ( P = 0.16 ) and glucose 46 % vs. 35 % ( P = 0.40 ) . CONCLUSION Pharmacist intervention was associated with improved BP control but not with the other MRF . Earlier initiation and longer duration of intervention may improve the outcome further , and whether targeting of high-risk subjects may be particularly rewarding is worthy of investigation",
"We examined the impact of ambulatory care clinical pharmacist interventions on clinical and economic outcomes of 208 patients with dyslipidemia and 229 controls treated at nine Veterans Affairs medical centers . This was a r and omized , controlled trial involving patients at high risk of drug-related problems . Only those with dyslipidemia are reported here . In addition to usual medical care , clinical pharmacists were responsible for providing pharmaceutical care for patients in the intervention group . The control group did not receive pharmaceutical care . Seventy-two percent of the intervention group and 70 % of controls required secondary prevention according to the National Cholesterol Education Program guidelines . Significantly more patients in the intervention group had a fasting lipid profile compared with controls ( p=0.021 ) . The absolute change in total cholesterol ( 17.7 vs 7.4 mg/dl , p=0.028 ) and low-density lipoprotein ( 23.4 vs 12.8 mg/dl , p=0.042 ) was greater in the intervention than in the control group . There were no differences in patients achieving goal lipid values or in overall costs despite increased visits to pharmacists . Ambulatory care clinical pharmacists can significantly improve dyslipidemia in a practice setting design ed to manage many medical and drug-related problems",
"OBJECTIVE To evaluate a pharmacist-conducted educational and monitoring programme , design ed to promote dietary and lifestyle modification and compliance with lipid-lowering drug therapy , for patients with dyslipidaemia . METHODS This was a prospect i ve , r and omized , controlled study . The participants were 94 adults , with 81 completing the study ( intervention group : 39 ; control group : 42 ) , with a cardiovascular-related diagnosis and discharged from hospital , between April and October 2001 , on lipid-lowering drug therapy . Patients in the intervention group were visited at home monthly by a pharmacist , who educated the patients on the goals of lipid-lowering treatment and the importance of lifestyle issues in dyslipidaemia and compliance with therapy , assessed patients for drug-related problems , and measured total blood cholesterol levels using point-of-care testing . Patients in the control group received st and ard medical care . The main outcome measure was total blood cholesterol levels after 6 months , and an evaluation of patient and general practitioner satisfaction with the programme . RESULTS There was no significant difference in baseline total blood cholesterol levels between the two groups . The reduction over the course of the study in cholesterol levels within the intervention group was statistically significant ( 4.9 + /- 0.7 to 4.4 + /- 0.6 , P cholesterol levels below 4.0 mmol/L ( P=0.06 ) . The reduction in total cholesterol in the intervention group should translate to an expected 21 % reduction in cardiovascular mortality risk and a 16 % reduction in total mortality risk -- more than twice the risk reduction achieved in the control group . In addition , the programme was very well received by the patients and their general practitioners , by satisfaction question naire . CONCLUSION A pharmacist-conducted educational and monitoring intervention improved the outcomes of lipid-lowering drug therapy",
"OBJECTIVE To evaluate the impact of pharmaceutical care on selected clinical and economic outcomes in patients with hypertension or chronic obstructive pulmonary disease ( COPD ) in ambulatory care setting s. DESIGN Clinic patients with hypertension or COPD were r and omly assigned to a treatment group ( pharmaceutical care ) or a control group ( traditional pharmacy care ) over a six-month period . Clinical pharmacists and pharmacy residents conducted the protocol s. There were 133 evaluable patients ( 63 treatment and 70 control ) in the hypertension study arm and 98 evaluable patients ( 43 treatment and 55 control ) in the COPD study arm . SETTING 10 Departments of Veterans Affairs medical centers and 1 academic medical center . INTERVENTIONS Patient-centered pharmaceutical care model ( employing st and ardized care ) implemented by clinical pharmacy residents . MAIN OUTCOME MEASURES Patient knowledge , medication compliance , and health re source use . RESULTS The hypertension treatment group had a significantly greater reduction in systolic blood pressure from visit 1 to visit 5 than did the control group . In the COPD study arm , trends were positive in the treatment group for patients ratings of symptom interference with activities and dyspnea measures . There was a significant difference between the hypertension treatment and control group for compliance . There were no significant changes in compliance scores in the COPD study arm . Mean number of hospitalizations and other health care provider visits was higher for the hypertension control group . For patients with COPD , hospitalizations increased in the control group , and the number of other health care provider visits was higher in the control group . CONCLUSION Pharmacists ' participation in a pharmaceutical care program result ed in disease state improvement in ambulatory patients with hypertension and COPD",
"OBJECTIVE To determine whether pharmaceutical care provided by a pharmacist-managed hypertension clinic results in better treatment outcomes when compared with traditional health care from a primary care physician . DESIGN Prospect i ve , controlled study SETTING Veterans Affairs Medical Center , Philadelphia , Pennsylvania . PATIENTS Fifty six patients with essential hypertension ; 27 were r and omly assigned to the intervention group and 29 to the control group . INTERVENTION Patients in the intervention group were scheduled monthly to meet with a clinical pharmacist who made appropriate changes in prescribed drugs , adjusted dosages , and provided drug counseling in accordance with the hypertension guidelines in the sixth report of the Joint National Committee on the Detection , Evaluation , and Treatment of High Blood Pressure ( JNC VI ) . Patients in the control group received st and ard care from their physicians . The study period was 6 months . MEASUREMENTS AND MAIN RESULTS Treatment outcomes were measured by changes in compliance , blood pressure , and patient satisfaction . The Short Form-36 health survey and a patient satisfaction survey were used to measure changes in patient satisfaction , and a compliance evaluation survey measured compliance . Twenty-one ( 81 % ) patients in the intervention group attained their blood pressure goal of below 140/90 mm Hg at the completion of the study versus only eight ( 30 % ) in the control group ( p patients with diabetes in the intervention group , 10 ( 91 % ) attained their blood pressure goal ( patients with diabetes in the control group ( p patient satisfaction or compliance were reported between the intervention and control groups . CONCLUSIONS Pharmaceutical care improves blood pressure control and results in more patients with hypertension reaching their blood pressure goal",
"PURPOSE To assess the efficacy of a pharmacist-led , primary care-based , disease management program to improve cardiovascular risk factors and glycated hemoglobin ( A(1C ) ) levels in vulnerable patients with poorly controlled diabetes . METHODS A r and omized controlled trial of 217 patients with type 2 diabetes and poor glycemic control ( A(1C ) level > or=8.0 % ) was conducted at an academic general medicine practice from February 2001 to April 2003 . Intervention patients received intensive management from clinical pharmacists , as well as from a diabetes care coordinator who provided diabetes education , applied algorithms for managing glucose control and decreasing cardiovascular risk factors , and addressed barriers to care . Control patients received a one-time management session from a pharmacist followed by usual care from their primary care provider . Outcomes were recorded at baseline and at 6 and 12 months . Primary outcomes included blood pressure , A(1C ) level , cholesterol level , and aspirin use . Secondary outcomes included diabetes knowledge , satisfaction , use of clinical services , and adverse events . RESULTS For the 194 patients ( 89 % ) with 12-month data , the intervention group had significantly greater improvement than did the control group for systolic blood pressure ( -9 mm Hg ; 95 % confidence interval [ CI ] : -16 to -3 mm Hg ) and A(1C ) level ( -0.8 % ; 95 % CI : -1.7 % to 0 % ) . Change in total cholesterol level was not significant . At 12 months , aspirin use was 91 % in the intervention group versus 58 % among controls ( P diabetes knowledge and satisfaction than did control patients . There were no significant differences in use of clinical services or adverse events . CONCLUSION Our comprehensive disease management program reduced cardiovascular risk factors and A(1C ) levels among vulnerable patients with type 2 diabetes and poor glycemic control",
"CONTEXT Treating hypertension decreases mortality and disability from cardiovascular disease , but most hypertension remains inadequately controlled . OBJECTIVE To determine if a new model of care that uses patient Web services , home blood pressure ( BP ) monitoring , and pharmacist-assisted care improves BP control . DESIGN , SETTING , AND PARTICIPANTS A 3-group r and omized controlled trial , the Electronic Communications and Home Blood Pressure Monitoring study was based on the Chronic Care Model . The trial was conducted at an integrated group practice in Washington state , enrolling 778 participants aged 25 to 75 years with uncontrolled essential hypertension and Internet access . Care was delivered over a secure patient Web site from June 2005 to December 2007 . INTERVENTIONS Participants were r and omly assigned to usual care , home BP monitoring and secure patient Web site training only , or home BP monitoring and secure patient Web site training plus pharmacist care management delivered through Web communications . MAIN OUTCOME MEASURES Percentage of patients with controlled BP ( mm Hg ) and changes in systolic and diastolic BP at 12 months . RESULTS Of 778 patients , 730 ( 94 % ) completed the 1-year follow-up visit . Patients assigned to the home BP monitoring and Web training only group had a nonsignificant increase in the percentage of patients with controlled BP ( Web-based pharmacist care to home BP monitoring and Web training significantly increased the percentage of patients with controlled BP ( 56 % ; 95 % CI , 49%-62 % ) compared with usual care ( P Systolic BP was decreased stepwise from usual care to home BP monitoring and Web training only to home BP monitoring and Web training plus pharmacist care . Diastolic BP was decreased only in the pharmacist care group compared with both the usual care and home BP monitoring and Web training only groups . Compared with usual care , the patients who had baseline systolic BP of 160 mm Hg or higher and received home BP monitoring and Web training plus pharmacist care had a greater net reduction in systolic BP ( -13.2 mm Hg [ 95 % CI , -19.2 to -7.1 ] ; P diastolic BP ( -4.6 mm Hg [ 95 % CI , -8.0 to -1.2 ] ; P improved BP control ( relative risk , 3.32 [ 95 % CI , 1.86 to 5.94 ] ; P Pharmacist care management delivered through secure patient Web communications improved BP control in patients with hypertension . Trial Registration clinical trials.gov Identifier : NCT00158639",
"Background : Few studies have reported the efficacy of collaborative care involving family physicians and community pharmacists for patients with dyslipidemia . Methods : We r and omly assigned clusters consisting of at least two physicians and at least four pharmacists to provide collaborative care or usual care . Under the collaborative care model , pharmacists counselled patients about their medications , requested laboratory tests , monitored the effectiveness and safety of medications and patients ’ adherence to therapy , and adjusted medication dosages . After 12 months of follow-up , we assessed changes in low-density lipoprotein ( LDL ) cholesterol ( the primary outcome ) , the proportion of patients reaching their target lipid levels and changes in other risk factors . Results : Fifteen clusters representing a total of 77 physicians and 108 pharmacists were initially recruited , and a total of 51 physicians and 49 pharmacists were included in the final analyses . The collaborative care teams followed a total of 108 patients , and the usual care teams followed a total of 117 patients . At baseline , mean LDL cholesterol level was higher in the collaborative care group ( 3.5 v. 3.2 mmol/L , p = 0.05 ) . During the study , patients in the collaborative care group were less likely to receive high-potency statins ( 11 % v. 40 % ) , had more visits with health care professionals and more laboratory tests , were more likely to have their lipid-lowering treatment changed and were more likely to report lifestyle changes . At 12 months , the crude incremental mean reduction in LDL cholesterol in the collaborative care group was −0.2 mmol/L ( 95 % confidence interval [ CI ] −0.3 to −0.1 ) , and the adjusted reduction was −0.05 ( 95 % CI −0.3 to 0.2 ) . The crude relative risk of achieving lipid targets for patients in the collaborative care group was 1.10 ( 95 % CI 0.95 to 1.26 ) , and the adjusted relative risk was 1.16 ( 95 % CI 1.01 to 1.34 ) . Interpretation : Collaborative care involving physicians and pharmacists had no significant clinical impact on lipid control in patients with dyslipidemia . International St and ard R and omized Controlled Trial register no. IS RCT N66345533"
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INTRODUCTION The use of self-etch primers has increased steadily because of their time savings and greater simplicity ; however , overall benefits and potential disadvantages and harms have not been assessed systematic ally . In this study , we review ed r and omized controlled trials to assess the risk of attachment failure , bonding time , and demineralization adjacent to attachments between 1-stage ( self-etch ) and 2-stage ( acid etch ) bonding in orthodontic patients over a minimum follow-up period of 12 months . METHODS Data sources were electronic data bases including MEDLINE , EMBASE , the Cochrane Oral Health Group 's Trials Register , and CENTRAL , without language restrictions . Unpublished literature was search ed on Clinical Trials.gov , the National Research Register , and Pro-Quest Dissertation Abstract s and Thesis data base . Authors were contacted when necessary , and reference lists of the included studies were screened . Search terms included r and omized controlled trial , controlled clinical trial , r and om allocation , double-blind method , single-blind method , orthodontics , self-etch , SEP , primer , and bonding agent . R and omized clinical trials directly comparing self-etch and acid-etch primers with respect to the predefined outcomes and including patients with full-arch , fixed , and bonded orthodontic appliances ( not b and ed ) with follow-up periods of at least 12 months were included . Using predefined forms , 2 authors undertook independent data extraction with conflict resolution by the third author . R and omized clinical trial quality assessment based on the Cochrane Risk of Bias tool was also used . RESULTS Eleven studies met the inclusion criteria ; 6 were excluded because of a high risk of bias . In total , 1721 brackets bonded with acid-etch and 1723 with self-etch primer techniques were included in the quantitative synthesis . Relatively low statistical and clinical heterogeneity was observed among the 5 r and omized clinical trials ( n = 3444 brackets ) comparing acid-etch with self-etch primers . A r and om effects meta- analysis demonstrated a tendency for a higher risk of failure ( odds ratio , 1.35 ; 95 % CI , 0.99 - 1.83 ; P = 0.06 ) with self-etch primers . A small but statistically significant time saving was also associated with the self-etch primer technique ( weighted mean difference , 23.2 seconds per bracket ; 95 % CI , 20.7 - 25.8 ; P demineralization rates . CONCLUSIONS There is weak evidence indicating higher odds of failure with self-etch primer than acid etch over 12 months in orthodontic patients , and there is strong evidence that a self-etch primer is likely to result in a modest time savings ( 8 minutes for full bonding ) compared with acid etch
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"This clinical trial evaluated , over a 12-month period , the performance of brackets bonded to teeth etched and primed with Transbond Plus Self-Etching Primer ( SEP ) when compared with a conventional separate two-step etch and primer system . Thirty-nine r and omly selected patients requiring fixed appliance therapy were entered into the study . R and om allocation of each etching system , along with a ' split-mouth cross-quadrant ' design was used . A total of 661 brackets were placed by two operators . The failure and survival rates of the brackets were determined for age and gender of the patients , each etching system , operator , mode of failure , tooth position in the dental arch , and number of manipulations prior to curing the adhesive . Statistical analysis showed that SEP had a significantly higher bond failure rate ( 11.2 per cent ) than the conventional etch and primer system ( 3.9 per cent ) at the P = 0.001 level . Cox 's proportional hazards regression showed the conventional etch and primer system to have a 60 per cent reduced chance of bracket failure over a 12-month observation period , while males had a 2.4 times increased risk compared with females . The predominant mode of failure was at the composite enamel interface for the SEP , while for the conventional etch and primer system , it was within the composite adhesive . No statistically significant differences were found for the failure rate with respect to the age of the patient , operator , tooth location , or the number of manipulations of the bracket . This in vivo study showed that brackets bonded using SEP had an increased clinical bond failure rate compared with the conventional , separate , etch and prime system",
"Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement",
"OBJECTIVES Comparative assessment of the failure rate of molar tubes bonded to first and second molars with a self-etching primer and conventional acid-etching . MATERIAL AND METHODS Four hundred forty-four molar tubes ( 246 first molar tubes and 198 second molar tubes ) were bonded , using a split-mouth design , on 62 patients ( 23 male , 39 female ; mean age 13.7 years ) with the 3 M Transbond Plus self-etching primer combined with Transbond XT paste ; or with conventional acid-etching , Orthosolo primer , and Enlight adhesive paste . First-time failures were recorded over a period of 15 months . RESULTS Bond failure per adhesive system , arch ( maxilla-m and ible ) , quadrant ( left , right ) and tooth ( first or second molar ) were studied . Statistical analysis using logistic regression modeling ( alpha = .05 ) showed that the overall failure rate for the first and second molar tubes was 11 % ( 8 % with self-etching primer and 13 % with conventional acid-etching ) . No significant difference was found between the 2 bonding methods . Tooth location and type showed statistically significant associations . M and ibular tubes showed a 3:1 probability for failure compared to maxillary tubes . Right-sided tubes demonstrated 3 times more failures when compared to left-sided tubes , and second molar tubes showed a 3-fold increase in failure . CONCLUSION Molar tube bonding with self-etching primer shows similar success rates to conventional acid-etching , whereas the m and ibular right second molar presents the highest failure incidence",
"The aim of this study was to evaluate , over an 18-month period , the clinical performance of a self-etch adhesive [ Transbond Plus Self Etching Primer ( SEP ) , 3 M Unitek ] compared with a conventional adhesive that employs the etch- and -rinse approach ( Transbond XT , 3 M Unitek ) . One operator , using the straight-wire technique , bonded 567 metallic brackets to the teeth of 30 patients ( age range 12 - 18 years ) in a way that patients acted as self-control . The brackets were bonded following the manufacturers ' instructions except for the fact that the self-etch system was brushed for a longer time than recommended ( 10 - 15 seconds ) since previous investigations have reported that prolonged application times can improve the bonding efficacy of self-etch systems to enamel . The failure modes were visually classified into : adhesive-enamel , adhesive-bracket , and cohesive failure . The survival rates of the brackets were estimated by Kaplan-Meier and log-rank test ( P failure rates of the self-etch and conventional adhesives were 15.6 and 17.6 per cent , respectively . No significant differences in the survival rate were observed between the material s ( P > 0.05 ) . Most of the failures were cohesive and at the adhesive-enamel interface . There was no difference in the fracture debonding mode . These findings indicate that Transbond Plus SEP can be safely used for orthodontic brackets since the survival rates are similar to the conventional Transbond XT",
"INTRODUCTION Our aim in this r and omized clinical trial was to compare the failure rates of orthodontic brackets by using 2 self-etching primers ( SEPs ) ( Transbond Plus [ 3 M Unitek , Seefeld , Germany ] and Clearfil Protect Bond [ Kuraray Medical , Okayama , Japan ] ) with a split-mouth design . Additionally , the effect of Clearfil Protect Bond was investigated regarding inhibition of plaque accumulation and demineralization . METHODS A total of 480 brackets were bonded in 24 patients with the SEPs . The observation period was 12 months . One week after bonding and at every third recall , the plaque index and a visual rating of the enamel adjacent to the bracket were assessed at the lateral incisors and the first premolars . Additionally , DIAGNOdent ( KaVo , Biberach , Germany ) values were measured . RESULTS Over the investigation time , 26 failures were recorded . Five occurred with the brackets bonded with Transbond Plus , and the rest with Clearfil Protect Bond ( P = 0.002 ) . The additionally observed parameters had no significant differences . CONCLUSIONS The failure rate with Clearfil Protect Bond was significantly higher . For our patients , who had adequate oral hygiene , there was no benefit with regard to plaque accumulation and prevention of demineralization with Clearfil Protect Bond",
"Objective The primary objective of this prospect i ve clinical trial was to assess the clinical bond failure rates of orthodontic brackets bonded using a self-etching primer ( SEP ) , compared with brackets bonded using a conventional acid-etched technique with control adhesive ( Transbond ™ ) . A secondary aim was to investigate whether characteristics of the operator , patient or tooth bonded had any influence on bracket failure . Design Single-centre r and omized controlled clinical trial . Thirty-four patients were bonded , each being r and omly assigned to either the test or control adhesive . Setting NHS Hospital Orthodontic Department , Chester , UK . Subjects Orthodontic patients requiring fixed appliance treatment . Main outcome measures Bond failure . Main outcome results Failure rates over the initial 6-month period were 2.0 % ( Transbond ™ ) and 1.7 % ( SEP ) with no statistically significant difference between the two groups . Over the duration of the fixed appliance treatment , bond failure rates increased , but remained acceptable at 7.4 % ( TB ) and 7.0 % ( SEP ) , respectively . When operator , patient and tooth characteristics were analysed , only the bracket location was found to be significant . Maxillary brackets were more likely to fail than m and ibular brackets ( RR 0.47 % ; 95 % CI 0.22 , 1.03 ) . The failure rate for brackets in our study was low when compared with previous studies . Conclusions Both the acid-etched control and self-etching primer in combination with adhesive pre-coated brackets were successful for clinical bonding . Their combined failure rate was lower than that reported in similar trials",
"Objective This study assessed the in vivo bond failure of the single component orthodontic self-etching primer system , Ideal 1 ( GAC Orthodontic Products ) and compared it with the conventional acid etching using a conventional 37 % o-phosphoric acid , rinsing and drying regimen when bonding stainless steel orthodontic brackets to enamel . Design Prospect i ve r and omized , controlled clinical trial . Setting Orthodontic Department , Bristol Dental School . Material and methods Twenty consecutive patients undergoing upper and lower fixed orthodontic treatment entered this cross-mouth control study . Diagonally opposite quadrants were r and omly allocated to either the self-etching primer group or the conventional etching group . A total of 339 teeth were bonded with Ideal 1 light-cured adhesive . Bond failures and locus of bond failure were then recorded at 1 , 6 and 12 months . Results Significantly more bond failures occurred at each of the 3 time intervals , 1 , 6 and 12 months , where the enamel was pretreated with the Ideal I self-etching primer , than when the enamel was treated with the conventional etchant , 37 % o-phosphoric acid . With the latter the cumulative bond failure rates were 3.0 , 5.3 and 14.8 % , respectively . With the self-etching primer the cumulative failure rates were 29.4 , 56.5 and 72.4 % . Conclusion The study found that enamel pre-treatment with the Ideal 1 self-etching primer system prior to orthodontic bonding results in an unacceptably high bond failure rate when compared with conventional enamel acid etching",
"The aim of the study was to compare the mean clinical chair-side time required for bracket bonding and the mean bond failure rate at 6 and 12 months of stainless steel brackets with a micro-etched base bonded with a light-cured composite using a self-etching primer ( SEP ) or a two-stage etch and prime system . Fifty-one subjects who required upper and /or lower pre-adjusted edgewise fixed appliances were recruited in a single centre r and omized clinical trial . The trial was a single-blind design , involving a within-patient comparison of the two bonding systems with each patient r and omly allocated the two bonding systems for each side of the mouth ( all teeth except molars ) . The two bonding techniques used were st and ardized throughout the trial and all bracket bonding was performed by a single operator . Bonding time was recorded using a digital timer . The bond failure rate of a strictly paired sample was recorded at 6 and 12 months for each patient . The mean bracket bonding time per patient with the SEP was significantly less than that with the two-stage bonding system ( mean difference 24.9 seconds ; 95 per cent confidence interval 22.1 - 27.7 seconds ; paired t-test P overall bond failure rates at 6 and 12 months with the SEP were 0.8 and 1.6 per cent , respectively , and for the two-stage etch and prime 1.1 and 3.1 per cent , respectively . At 6 months , the mean bond failure rate per patient with the SEP was 0.81 per cent and with the two-stage bonding system 0.96 per cent ( P = 0.87 ; Wilcoxon signed rank test ) . At 12 months , the mean bond failure rate with the SEP per patient was 1.54 per cent and with the two-stage bonding system 2.78 per cent ( P = 0.33 ; Wilcoxon signed rank test ) . The mean bracket bonding time with the SEP per patient was significantly shorter than that of the two-stage bonding system ( P difference between the overall bond failure rate and the mean bond failure rate per patient for the two bonding systems was not statistically nor clinical ly significant at 6 and 12 months ( P = 1.00 and P = 0.125 , respectively ; McNemar 's test )",
"At an orthodontic meeting in recent years , a colleague recounted to me that when a presenter had finished their presentation on a systematic review , the person beside leaned over and said to my colleague ‘ not another systematic review where it ’s not possible to draw any firm conclusions ’ . So an element of frustration was clear based on the screening of a large volume of evidence to arrive at such a low point for a conclusion . This , however , is now a familiar outcome for many orthodontic systematic review s. In this short editorial , I have attempted to give a brief outline of the proposed benefits of systematic review s but more importantly , to highlight , some issues we all need to bear in mind in their regard . The increasing focus on evidence -based healthcare , including orthodontics , has shunned the narrative review and spawned the systematic review . Aim ing to identify , evaluate and summarize the findings of all relevant studies on a specific topic , its exacting systematic approach should minimize bias and provide conclusions based on reliable findings . Meta-analyses of r and omized clinical trials with low risk of bias are considered the highest level of evidence available for evaluating the effects of an intervention . Systematic review s are also important tools in setting the research agenda via their recommendations for future research and authors can alert research ers to the most pertinent outcomes in clinical practice . But systematic review s like any other study type are not without their variability , both in dentistry in general and specifically in orthodontics . Large differences have also been observed in the quality of reporting of several characteristics between Cochrane and non-Cochrane systematic review s. A key question that must be asked when looking at all Cochrane review s is whether the review has been undertaken in a way to avoid bias and whether the data and results from the included studies are valid . Conclusions may be distorted if bias is introduced to the review process at any stage . For example , incomplete search ing for all relevant studies may lead to publication bias ; there is strong association between publication and studies reporting significant or positive findings in medicine and also within orthodontics . With regard to studies included within the review , these need to be assessed to ensure that they are undertaken and reported in a manner that is free of bias ( systematic error ) . Outcome reporting bias ( ORB ) may also be relevant , e.g. in a study identified as relevant to a review , where data exist on the outcome of interest but only selected findings have been given based on the results . Although systematic review s have emphasized ‘ assessment of method ological quality ’ of included studies , the Cochrane h and book recommends a focus on ‘ risk of bias assessment ’ instead . The justifications are four-fold : it targets whether the results of included studies should be credible ; despite being carried out to the highest st and ards , a study may have risk of bias due to , e.g. impracticality/impossibility of blinding of participants / study personnel ; some quality markers , e.g. a power calculation is unlikely to directly affect risk of bias ; it overcomes ambiguity between quality of reporting and quality of the underlying research",
"Objective A long-term comparison of the failure rates of orthodontic brackets bonded with either a self-etching primer ( SEP ) or conventional etch and primer ( AE ) . Design Prospect i ve r and omized controlled clinical trial . Setting UK district general hospital with one operator , 2003–6 . Participants Hospital waiting list patients needing fixed appliances ( n=60 ) . Method Experimental ( SEP ) group patients ( n=30 ) received pre-adjusted edgewise brackets ( n=438 ) bonded with Transbond Plus following manufacturer 's instructions . Control ( AE ) group patients ( n=30 , brackets n=433 ) were bonded using a 15-second conventional etch and primer ( Transbond XT ) . In both groups brackets were light-cured for 20 seconds . First-time bond failures were recorded with the time of failure . Bracket bonding time was recorded . All patients were followed to the end or discontinuation of treatment . Results Bracket failure rates : SEP=4.8 % , AE=3.5 % , P=0.793 . Mean placement time per bracket ( seconds ) : SEP=75.5 ( ±6.7 ; 95 % CI=72.9 , 78.0 ) , AE=97.7 ( ±9.1 ; 95 % CI=94.3 , 101.2 ) P=0.000 . Conclusion There was no difference in the failure rates of brackets bonded with either Transbond Plus SEP or conventional AE using Transbond XT paste . Bonding with SEP was significantly faster than using conventional AE ",
"INTRODUCTION Self-etching primers ( SEP ) have simplified the orthodontic bonding process , but questions have arisen regarding their reliability and efficiency . The goal of this study was to assess the importance of a pumice prophylaxis before bonding in reducing bond failures . METHODS Thirty orthodontic patients volunteered to participate in this prospect i ve clinical trial . A split-mouth design was used ; in each patient , 1 quadrant was r and omly assigned to the pumice prophylaxis experimental group and the contralateral quadrant to the nonpumice group . A total of 508 teeth were bonded with SEP ( Transbond Plus ; 3 M Unitek , Monrovia , Calif ) and monitored for 3 months for bond failures . RESULTS Thirty-five failures ( 6.9 % ) were recorded , with 6 ( 2.4 % ) in the pumice group and 29 ( 11.4 % ) in the nonpumice group . Chi-square analysis was used to compare bond failures as a total number between groups and also as the number of patients who experienced bond failures with each method . Statistically significant differences were found both in the total number of bond failures ( P number of patients with bond failures between groups ( P clinical ly acceptable bond failure rate was demonstrated with Transbond Plus SEP after pumice prophylaxis . CONCLUSIONS This study produced strong evidence suggesting the need for pumice prophylaxis when using SEP for orthodontic bonding",
"INTRODUCTION The purpose of this clinical trial was to evaluate over a 12-month period the performance of a self-etching system ( SEP ) ( Transbond Plus SEP , 3 M Unitek , Monrovia , Calif ) compared with a conventional multi-step system ( TBXT ) ( Transbond XT , 3 M Unitek ) . METHODS Twenty-eight r and omly selected patients were included in this study . They were r and omly assigned to either the TBXT or the SEP group . A total of 548 brackets were bonded according to the manufacturer 's instructions with Transbond XT adhesive paste ( 3 M Unitek ) . The survival rates of brackets were estimated with the Kaplan-Meier analysis . Bracket survival distributions for bonding procedure , tooth location , dental arch , and patient sex were compared with the log-rank test . RESULTS The failure rates of the TBXT and SEP groups were 4.78 % and 6.88 % , respectively . No significant differences in the survival rates were observed between the bonding procedures ( P = 0.311 ) . When tooth location , dental arch , and sex were analyzed , only tooth location was significant . Posterior brackets were more likely to fail than anterior brackets ( P = 0.013 ) . CONCLUSIONS Both systems had low bond failure rates and are adequate for orthodontic bonding needs"
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Cow ’s milk protein allergy ( CMPA ) is the commonest food allergy in infancy and is associated with significant health burden . Given their immune modulatory properties , probiotics have been proposed as a strategy for management of CMPA . We aim ed to systematic ally review efficacy and safety of probiotics in the management of CMPA . Data bases PubMed , EMBASE , CINAHL , Cochrane Central Library , and Google scholar were search ed in August 2018 for r and omized controlled trials ( RCT ) of probiotic supplementation as an adjunct in the management of infants with suspected/proven CMPA . Primary outcomes were resolution of hematochezia and acquisition of tolerance to CMP at 6 , 12 , 24 , and 36 months . Secondary outcomes included effect on allergic symptoms ( SCORAD index ) , growth , gut microbiota , and adverse effects . A total of 10 RCTs ( n = 845 ; probiotics , 422 ; control , 423 ) with low to unclear risk of bias were included . Meta- analysis showed probiotic supplementation was not associated with earlier resolution of hematochezia ( n = 87 ; RR : 1.45 ( 95 % CI : 0.96–2.18 ) , p = 0.08 ; level of evidence ( LOE ) , very low ) , in presumed CMPA . In confirmed CMPA , probiotics were associated with higher rate of acquisition of tolerance to CMP at the end of 3 years compared with placebo ( N = 493 ; RR , 1.47 ; 95 % CI , ( 1.17–1.84 ) ; p = 0.0009 ; LOE , low ] . Meta- analysis was not possible for other outcomes . There were no probiotic related adverse effects . Conclusion : Limited low- quality evidence indicates that probiotic supplementation may be associated with earlier acquisition of tolerance to CMP in children with CMPA . Large well- design ed trials are essential to confirm these findings .What is Known:• Cow ’s milk protein allergy ( CMPA ) is one of the commonest food allergies in children . CMPA is associated with significant socioeconomic burden.• Elimination diet and extensively hydrolyzed formula is the mainstay of the management of CMPA.What is New:• This first systematic review of r and omized controlled trials shows that probiotics as an adjuvant can lead to earlier acquisition of tolerance to CMP in children at 36 months of age . However , the evidence is low quality and influenced by data from one large study .• Probiotic supplementation was not associated with earlier resolution of hematochezia
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"A cohort of 1,749 newborns from the municipality of Odense , born during 1995 at the Odense University Hospital , were followed up prospect ively for the development of cow 's milk protein allergy/intolerance ( CMPA/I ) during the first year of life . Once a diagnosis of CMPA/I was confirmed , a milk-free diet was continued until a new milk challenge had shown development of tolerance . All infants with CMPA/I were rechallenged at 12 months of age and , in the event of continued clinical sensitivity to cow 's milk protein , controlled rechallenges were performed every 6 months up to 3 years of age ; and thereafter every 12 months until the age of 15 years . From the same birth cohort , 276 infants were r and omly selected at birth for prospect i ve non-interventional follow-up in order to investigate the natural course of sensitization and development of atopic disease during childhood . St and ardized question naires on atopic heredity , environmental factors and presence of atopic symptoms were answered at 0 , 6 , 12 and 18 months and at 5 , 10 and 15 years of age . Interviews on atopic history and environmental factors as well as physical examination were carried out at 18 months , 5 , 10 and 15 years of age . Skin prick test and specific sIgE ( Pharmacia CAP ) testing were performed at 18 months , 5 , 10 and 15 years of age against a panel of inhalant allergens ( birch , grass , mugwort , dog , cat , horse , Dermatophagoidespteronyssinus , Dermatophagoides farinae , alternaria and cladosporium herbarum ) . Furthermore , lung function measurements were performed in children when 10 and 15 years of age . Based on controlled milk elimination and challenge procedures , the diagnosis of CMPA/I was confirmed in 39 out of 117 infants , with symptoms suggestive of CMPA/I , thus result ing in a 1-year incidence of CMPA/I of 2.2 % . The overall prognosis of CMPA/I was good , with a total recovery of 56 % at 1 year , 77 % at 2 years , 87 % at 3 years , 92 % at 5 and 10 years and 97 % at 15 years of age . In children younger than 10 years of age , 41 % developed asthma and 31 % rhinoconjunctivitis . Children with non-IgE-mediated CMPI had a good prognosis , whereas children with IgE-mediated CMPA in early childhood had a significantly increased risk for persistent CMPA , development of other food allergies , asthma and rhinoconjunctivitis . During early infancy , recurrent wheezing was the most prevalent disease ( 20 % ) , followed by atopic dermatitis ( 14 % ) and food allergy ( 7 % ) at 18 months of age . Physician diagnosed asthma increased from 2 % at 1.5 years of age to 9 % at 10 years of age . Rhinoconjunctivitis increased from prevalence of any atopic disease was 20 % at 1.5 years of age , declining to 14 % at 5 years of age and followed by an increase to 25 % at 10 years of age . Sensitization to inhalant and /or food allergens ( specific IgE of > or = class 2 ; CAP RAST ) showed a low rate of sensitization among asymptomatics ( 3 % , 10 % and 12 % ) compared with higher rates of sensitization of 8 % , 39 % and 30 % among symptomatic atopics at 1.5 , 5 and 10 years of age respectively . The highest rate of sensitization ( 53 % ) was found among children with current asthma at 10 years of age",
"Background Prebiotics and probiotics ( synbiotics ) can modify gut microbiota and have potential in allergy management when combined with amino-acid-based formula ( AAF ) for infants with cow ’s milk allergy ( CMA ) . Methods This multicenter , double-blind , r and omized controlled trial investigated the effects of an AAF-including synbiotic blend on percentages of bifidobacteria and Eubacterium rectale/Clostridium coccoides group ( ER/CC ) in feces from infants with suspected non-IgE-mediated CMA . Feces from age-matched healthy breastfed infants were used as reference ( healthy breastfed reference ( HBR ) ) for primary outcomes . The CMA subjects were r and omized and received test or control formula for 8 weeks . Test formula was a hypoallergenic , nutritionally complete AAF including a prebiotic blend of fructo-oligosaccharides and the probiotic strain Bifidobacterium breve M-16V . Control formula was AAF without synbiotics . Results A total of 35 ( test ) and 36 ( control ) subjects were r and omized ; HBR included 51 infants . At week 8 , the median percentage of bifidobacteria was higher in the test group than in the control group ( 35.4 % vs. 9.7 % , respectively ; P P were 55 % and 6.5 % , respectively . Conclusion AAF including specific synbiotics , which results in levels of bifidobacteria and ER/CC approximating levels in the HBR group , improves the fecal microbiota of infants with suspected non-IgE-mediated CMA",
"Background Allergy to cow ’s milk protein ( CMP ) may cause gastrointestinal ( GI ) symptoms in the absence of CMP specific IgE. The immunological mechanisms involved in such disease are not fully understood . Therefore we examined markers of gut mucosal inflammation and the immunoglobulin profiles in children with Gl symptoms suspected of cow ’s milk protein allergy ( CMPA ) . Patients and methods We prospect ively recruited infants and young children ( n = 57 ; median age 8.7 months ) with gastrointestinal complaints suspected of CMPA . The diagnosis of CMPA was made using the double-blind , placebo-controlled food challenge . Serum and stool sample s were collected during CMP-free diet and after both placebo and active challenges . We analyzed the stool sample s for calprotectin , human β-defensin 2 and IgA. In serum , we analyzed the levels of β-lactoglobulin and α-casein specific IgA , and IgG antibodies ( total IgG and subclasses IgG1 and IgG4 ) . Control group included children with e.g. dermatological or pulmonary problems , consuming normal diets . Results Fecal calprotectin levels were higher in the challenge positive group ( n = 18 ) than in the negative ( n = 37 ) , with respective geometric means 55 μg/g [ 95 % confidence interval 38–81 ] and 29 [ 24–36 ] μg/g ( p = 0.0039 ) , during cow ’s milk free diet . There were no significant inter-group differences in the fecal β-defensin and IgA levels . The CMP specific IgG and IgA were not elevated in patients with CMPA , but the levels of β-lactoglobulin-IgG4 ( p = 0.0118 ) and α-casein-IgG4 ( p = 0.0044 ) , and total α-casein-IgG ( p = 0.0054 ) and -IgA ( p = 0.0050 ) in all patient sample s ( regardless of CMPA diagnosis ) were significantly lower compared to the control group using dairy products . Conclusions Despite cow ’s milk elimination in children intolerant to cow ’s milk there might be ongoing low- grade inflammation in the gut mucosa . CMP specific IgG or IgA should not be used to diagnose non-IgE CMPA . The observed frequency of impaired CMP specific total IgA , IgG and IgG4 production in patients following cow ’s milk free diet warrants further 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 Large , prospect i ve population -based studies on clinical course , development of tolerance , and risk for other atopy in children with cow 's milk allergy ( CMA ) are lacking . OBJECTIVE We investigated the development of tolerance and the risk for asthma , rhinoconjunctivitis , atopic dermatitis , and sensitization in children with CMA followed to school age . METHODS We followed 118 children with CMA until recovery and repeatedly measured their sensitization to cow 's milk ( CM ) . At age 8.6 years , 94 allergic subjects and 80 control subjects from the same cohort were studied for atopic diseases and sensitization . In addition , the parents of 12 allergic subjects and 26 control children returned a question naire on atopy , respectively . RESULTS IgE-mediated CMA was detected in 86 ( 73 % ) children ; at age 8.6 years , 13 ( 15 % ) had persistent CMA . All children with IgE-negative CMA were tolerant by age 5.0 years ( P sensitization to CM at age 1.6 years ( odds ratio , 6.3 ; 95 % CI , 2.6 - 15.2 ) , urticaria at diagnostic challenge ( odds ratio , 3.3 ; 95 % CI , 1.4 - 7.8 ) , CM exposure at the maternity hospital ( odds ratio , 3.2 ; 95 % CI , 1.4 - 7.8 ) , and early sensitization to egg ( odds ratio , 2.8 ; 95 % CI , 1.2 - 6.6 ) . By age 8.6 years , children with IgE-positive CMA more frequently had asthma ( 31 % vs 13 % , P rhinoconjunctivitis ( 66 % vs 21 % , P atopic eczema ( 81 % vs 26 % , P sensitization to any allergen ( 88 % vs 39 % , P CMA and family history of atopy were independent risk factors for atopic diseases , and CMA was also a risk factor for sensitization to inhalant allergens . CONCLUSION IgE-mediated CMA often persists to school age and is a risk factor for other atopy ; non-IgE-mediated CMA , by contrast , is a benign infantile condition",
"OBJECTIVES To determine the benefits of Lactobacillus rhamnosus GG ( LGG ) in an extensively hydrolyzed casein formula ( EHCF ) in improving hematochezia and fecal calprotectin over EHCF alone . STUDY DESIGN Fecal calprotectin was compared in 30 infants with hematochezia and 4 weeks after milk elimination with that of a healthy group . We also compared fecal calprotectin and hematochezia on 26 formula-fed infants r and omly assigned to EHCF with LGG ( Nutramigen LGG ) ( EHCF + LGG ) or without ( Nutramigen ) ( EHCF - LGG ) and on 4 breastfed infants whose mothers eliminated dairy . RESULTS Fecal calprotectin in those with hematochezia was significantly higher than in comparisons ( mean + /- SD 325.89 + /- 152.31 vs 131.97 + /- 37.98 microg/g stool , t = 6.79 , P fecal calprotectin decreased to 50 % of baseline but was still significantly higher than in comparisons ( 157.5 + /- 149.13 vs 93.72 + /- 36.65 microg/g , P = .03 ) . Fecal calprotectin mean decrease was significantly larger among EHCF + LGG compared with EHCF - LGG ( -214.5 + /- 107.93 vs -112.7 + /- 105.27 microg/g , t = 2.43 , P = .02 ) . At 4 weeks , none of the EHCF + LGG had blood in stools , and 5/14 on EHCF - LGG did ( P = .002 ) . CONCLUSION Fecal calprotectin is elevated in infants with hematochezia and possible allergic colitis . EHCF + LGG result ed in significant improvement of hematochezia and fecal calprotectin compared with the EHCF alone",
"Objective : Cow`s milk protein allergy usually occurs in infants within the first months of life . It can affect several organs , but gastrointestinal symptoms are the most clinical symptoms observed . The most effective treatment is restricting the cow ` s milk protein in mother and infant`s diet . Lactobacillus GG supplementation in infant could be effective through modulation of the immune system and the gut microflora . Methods : Thirty two breastfed infants with cow`s milk protein allergy were enrolled in a double-blinded r and omized controlled trial in which they received Synbiotic ( n=16 ) or placebo ( n=16 ) once a day for one month , simultaneously with cow`s milk protein restriction in mother and infant`s diet . Clinical gastrointestinal symptoms ( vomiting , colic , rectal bleeding and diarrhea ) , head circumference , body length and weight were recorded at the beginning , the end of the first and third month of study . Findings : Percentage of increment in head circumference and weight were statistically more in synbiotic group compared with placebo group at the end of the first and third month of study . There was no significant difference in resolution of clinical gastrointestinal symptoms ( vomiting , colic , rectal bleeding or diarrhea ) and percentage of increment in body length . Conclusion : Synbiotic supplementation in infants may improve increment of head circumference and weight gain , but has no effect on resolution of clinical symptoms",
"This study was design ed to assess whether a rice-hydrolysate formula allows normal growth and adequate metabolic balance in infants with cows ' milk protein allergy . Infants ( seven females , nine males ; aged 6–14 months ) were r and omly assigned to receive a rice-hydrolysate formula ( n = 8) or a soy formula ( control group , n = 8) . St and ardized growth indices ( Z scores ) and biochemical parameters were evaluated during a 6-month treatment period . Infants in both groups showed normal growth patterns during the study , and no adverse reactions were seen . Mean plasma biochemical parameters were within the normal ranges , and did not differ between groups . In conclusion , rice-hydrolysate formula may be a nutritionally suitable alternative for infants with cows ' milk protein allergy . Larger studies , with satisfactory power , should be undertaken to confirm these findings",
"OBJECTIVE To describe the natural course of IgE-mediated cow 's milk allergy ( IgE-CMA ) and to determine risk factors for its persistence in a population -based cohort . STUDY DESIGN In a prospect i ve cohort study , 54 infants with IgE-CMA were identified from a population of 13 019 children followed from birth . Diagnosis of IgE-CMA was based on history , skin prick test ( SPT ) , and an oral food challenge ( OFC ) when indicated . Allergic infants were followed for 48 - 60 months . Families were contacted by telephone every 6 months and asked about recent exposures to milk . OFC was repeated to evaluate for recovery . Clinical characteristics , SPT , and OFC outcomes were compared between infants with persistent IgE-CMA and infants who recovered . RESULTS Thirty-one infants ( 57.4 % ) recovered from IgE-CMA during the study period . Most infants ( 70.9 % ) recovered within the first 2 years . Risk factors for persistence on multivariate analysis included a reaction to on OFC ( or on first exposure as estimated by the guardian , if OFC was not performed ) ( P = .01 ) , a larger wheal size on SPT ( P = .014 ) , and age of ≤30 days at time of first reaction ( P = .05 ) . CONCLUSIONS Resolution occurs in most infants with IgE-CMA . Infants reacting to < 10 mL of milk or in the first month of life , and those with a larger wheal size on SPT , are at increased risk for persistence",
"Background Children with cow 's milk allergy ( CMA ) have an increased risk of other allergic manifestations ( AMs ) . Objective We performed a parallel‐arm r and omized controlled trial to test whether administration of an extensively hydrolyzed casein formula ( EHCF ) containing the probiotic Lactobacillus rhamnosus GG ( LGG ) can reduce the occurrence of other AMs in children with CMA . Methods Children with IgE‐mediated CMA were r and omly allocated to the EHCF or EHCF+LGG groups and followed for 36 months . The main outcome was occurrence of at least 1 AM ( eczema , urticaria , asthma , and rhinoconjunctivitis ) . The secondary outcome was tolerance acquisition , which was defined as the negativization of a double‐blind food challenge results at 12 , 24 , and 36 months . AMs were diagnosed according to st and ardized criteria . Tolerance acquisition was evaluated every 12 months . Results A total of 220 children ( 147 boys [ 67 % ] ) with a median age of 5.0 months ( interquartile range , 3.0‐8.0 months ) were r and omized ; 110 children were placed in the EHCF group , and 110 children were placed in the EHCF+LGG group . In the complete case analysis the absolute risk difference for the occurrence of at least 1 AM over 36 months was −0.23 ( 95 % CI , −0.36 to −0.10 ; P the absolute risk difference for the acquisition of cow 's milk tolerance was 0.20 ( 95 % CI , 0.05‐0.35 ; P effect size of the main outcome was virtually unchanged when the occurrence of AMs was assigned to all 27 missing children . Conclusions EHCF+LGG reduces the incidence of other AMs and hastens the development of oral tolerance in children with IgE‐mediated CMA",
"Children with cows ' milk protein allergy ( CMPA ) are at risk of insufficient length and weight gain , and the nutritional efficacy of hypo-allergenic formulas should be carefully assessed . In 2008 , a trial assessed the impact of probiotic supplementation of an extensively hydrolysed casein-based formula ( eHCF ) on acquisition of tolerance in 119 infants with CMPA . First analysis of the study results showed that the studied formula allowed improvement of food-related symptoms . The scoring of atopic dermatitis ( SCORAD ) index was assessed at r and omisation and after 6 months of feeding . A post hoc analysis was performed using WHO growth software 's nutritional survey module ( WHO Anthro version 3.2.2 ) . All infants who were fed the study formula tolerated it well . The SCORAD index significantly improved from r and omisation to 6 months of feeding with the study formula . Anthropometric data indicated a significant improvement in the weight-for-age , length-for-age and weight-for-length z scores , as well as in the restoration of normal BMI . The probiotic supplementation did not show any impact on these parameters . The present data showed that this eHCF was clinical ly tolerated and significantly improved the SCORAD index and growth indices",
"BACKGROUND Children with cow 's milk allergy ( CMA ) are at risk for inadequate nutritional intake and growth . Dietary management of CMA , therefore , requires diets that are not only hypoallergenic but also support adequate growth in this population . This study assessed growth of CMA infants when using a new amino acid-based formula ( AAF ) with prebiotics and probiotics ( synbiotics ) and evaluated its safety in the intended population . METHODS In a prospect i ve , r and omized , double-blind controlled study , full-term infants with diagnosed CMA received either an AAF ( control ; n = 56 ) or AAF with synbiotics ( oligofructose , long-chain inulin , acidic oligosaccharides , Bifidobacterium breve M-16V ) ( test ; n = 54 ) for 16 wk . Primary outcome was growth , measured as weight , length and head circumference . Secondary outcomes included allergic symptoms and stool characteristics . RESULTS Average age ( ±SD ) of infants at inclusion was 4.5 ± 2.4 months . Both formulas equally supported growth according to WHO 2006 growth charts and result ed in similar increases of weight , length and head circumference . At week 16 , differences ( 90 % CI ) in Z-scores ( test-control ) were as follows : weight 0.147 ( -0.10 ; 0.39 , p = 0.32 ) , length -0.299 ( -0.69 ; 0.09 , p = 0.21 ) and head circumference 0.152 ( -0.15 ; 0.45 , p = 0.40 ) . Weight-for-age and length-for-age Z-scores were not significantly different between the test and control groups . Both formulas were well tolerated and reduced allergic symptoms ; the number of adverse events was not different between the groups . CONCLUSIONS This is the first study that shows that an AAF with a specific synbiotic blend , suitable for CMA infants , supports normal growth and growth similar to the AAF without synbiotics . This clinical trial is registered as NCT00664768",
"BACKGROUND Previous analysis in a prospect i ve , population -based cohort reported reduced weight gain in children fed extensively hydrolyzed casein ( eHF-C ) formula during the first year of life but showed no effect on growth between 1 and 6 y of life . No studies have been conducted in children up to the age of 10 y. OBJECTIVE The objective was to investigate potential differences in body mass index ( BMI ) over the first 10 y of life between infants fed within the intervention period of the first 16 wk of life with partially hydrolyzed whey ( pHF-W ) , extensively hydrolyzed whey ( eHF-W ) , eHF-C , or cow-milk formula ( CMF ) and infants exclusively breastfed ( BF ) within the intervention period . DESIGN This was a prospect i ve , r and omized , double-blind trial in full-term neonates with atopic heredity in the German birth cohort German Infant Nutritional Intervention ( GINI ) followed through the first 10 y of life . Analyses of absolute and World Health Organization (WHO)-st and ardized BMI trajectories for 1840 infants [ pHF-W ( n = 253 ) , eHF-W ( n = 265 ) , eHF-C ( n = 250 ) , CMF ( n = 276 ) , and BF ( n = 796 ) ] were conducted according to intention-to-treat principles . RESULTS Except for the previously reported slower BMI gain in infants fed with eHF-C formula within the first year of life , no significant differences in absolute or WHO-st and ardized BMI trajectories were shown between the pHF-W , eHF-W , eHF-C , CMF , and BF groups thereafter up to the age of 10 y. CONCLUSIONS Extension of the follow-up period from 6 to 10 y for this r and omized controlled trial showed no long-term consequences on BMI for the 4 infant formulas considered . These data need to be confirmed in future studies",
"Objectives The aim of this study was to assess the efficacy of oral supplementation of viable and heat-inactivated probiotic bacteria in the management of atopic disease and to observe their effects on the composition of the gut microbiota . Methods The study population included 35 infants with atopic eczema and allergy to cow 's milk . At a mean age of 5.5 months , they were assigned in a r and omized double-blind manner to receive either extensively hydrolyzed whey formula ( placebo group ) or the same formula supplemented with viable ( viable LGG group ) or heat-inactivated Lactobacillus GG ( heat-inactivated LGG group ) , respectively . The changes in symptoms were assessed by the SCORAD method and the presence of some predominant bacterial genera in the feces detected with 16S rRNA-specific probes . Results The treatment with heat-inactivated LGG was associated with adverse gastrointestinal symptoms and diarrhea . Consequently , the recruitment of patients was stopped after the pilot phase . Within the study population , atopic eczema and subjective symptoms were significantly alleviated in all the groups ; the SCORAD scores ( interquartile range ) decreased from 13 ( range , 4–29 ) to 8 ( range , 0–29 ) units in the placebo group , from 19 ( range , 4–47 ) to 5 ( range , 0–18 ) units in the viable LGG group , and from 15 ( range , 0–29 ) to 7 ( range , 0–26 ) units in the heat-inactivated LGG group . The decrease in the SCORAD scores within the viable LGG group tended to be greater than within the placebo group . The treatments did not appear to affect the bacterial numbers within the genera enumerated . Conclusions Supplementation of infant formulas with viable but not heat-inactivated LGG is a potential approach for the management of atopic eczema and cow 's milk allergy",
"Objectives : For breast-fed infants with rectal bleeding , maternal restriction of dietary protein such as cow 's milk proteins is often recommended ; however , poor response to dietary protein restriction is of concern . This pilot study was design ed to assess the effectiveness of Lactobacillus GG ( LGG ) in breast-fed infants with rectal bleeding . Patients and Methods : Breast-fed infants were enrolled in a double-blind r and omized controlled trial in which they received LGG 3 × 109 colony-forming units ( n = 14 ) or placebo ( n = 15 ) twice daily for 4 weeks as an adjunct to cow 's milk restriction in the mother 's diet . Analyses were based on allocated treatment and included data from 26 infants . Results : Mean duration of rectal bleeding was similar in the LGG and control groups ( 17.3 ± 10.6 vs 15.4 ± 11 days ; mean difference −1.9 ( 95 % confidence interval [ CI ] −4 to 7 ) . No difference was found in the number of infants with clinical resolution of rectal bleeding within 72 hours and no relapse afterward ( 2/11 vs 3/15 , relative risk [ RR ] 0.9 , 95 % CI 0.2–3.9 ) and the number of infants with clinical resolution of rectal bleeding within 72 hours followed by relapse of symptoms ( 5/11 vs 5/15 , RR 1.4 , 95 % CI 0.5–3.5 ) . Breast-feeding cessation was not needed in any infant . Conclusions : These results do not support the use of LGG as an adjunct to maternal cow 's milk restriction in breast-fed infants with rectal bleeding ",
"BACKGROUND Cow 's milk allergy ( CMA ) is the most frequently diagnosed food allergy in infancy . In general , patients have a good prognosis because the majority acquire tolerance within the first years . Interventions have been proposed to accelerate tolerance and reduce morbidity . Probiotic supplementation could be effective through modulation of the immune system . OBJECTIVE We sought to determine whether supplementation with a combination of probiotics ( Lactobacillus casei CRL431 and Bifidobacterium lactis Bb-12 ) accelerates tolerance to cow 's milk ( CM ) in infants with CMA . METHODS We performed a double-blind , r and omized , placebo-controlled trial in 119 infants with CMA . Infants received CRL431 and Bb-12 supplemented to their st and ard treatment of extensively hydrolyzed formula for 12 months . Primary outcome was clinical tolerance to CM at 6 and 12 months of treatment . Furthermore , we analyzed T- and B-lymphocyte subsets ( CD3(+ ) , CD3(+)CD4(+ ) , CD3(+)CD8(+ ) , and CD20(+ ) ) in peripheral blood at r and omization and at 12 months with flow cytometry and examined the presence of viable probiotic strains in fecal sample s. RESULTS The cumulative percentage of tolerance to CM at 6 and 12 months was similar in both groups : 56 ( 77 % ) in the probiotics group versus 54 ( 81 % ) in the placebo group . Infants in the placebo group had higher percentages of CD3(+ ) and CD3(+)CD4(+ ) lymphocytes compared with those seen in probiotic-treated infants . Probiotic intake was confirmed because probiotics were isolated from feces more often in treated infants than in the placebo group . CONCLUSION Supplementation of CRL431 and Bb-12 to extensively hydrolyzed formula does not accelerate CM tolerance in infants with CMA"
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BACKGROUND Work-related upper limb disorder ( WRULD ) , repetitive strain injury ( RSI ) , occupational overuse syndrome ( OOS ) and work-related complaints of the arm , neck or shoulder ( CANS ) are the most frequently used umbrella terms for disorders that develop as a result of repetitive movements , awkward postures and impact of external forces such as those associated with operating vibrating tools . Work-related CANS , which is the term we use in this review , severely hampers the working population . OBJECTIVES To assess the effects of conservative interventions for work-related complaints of the arm , neck or shoulder ( CANS ) in adults on pain , function and work-related outcomes . SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( The Cochrane Library , 31 May 2013 ) , MEDLINE ( 1950 to 31 May 2013 ) , EMBASE ( 1988 to 31 May 2013 ) , CINAHL ( 1982 to 31 May 2013 ) , AMED ( 1985 to 31 May 2013 ) , PsycINFO ( 1806 to 31 May 2013 ) , the Physiotherapy Evidence Data base ( PEDro ; inception to 31 May 2013 ) and the Occupational Therapy Systematic Evaluation of Evidence Data base ( OTseeker ; inception to 31 May 2013 ) . We did not apply any language restrictions . SELECTION CRITERIA We included r and omised controlled trials ( RCTs ) and quasi-r and omised controlled trials evaluating conservative interventions for work-related complaints of the arm , neck or shoulder in adults . We excluded trials undertaken to test injections and surgery . We included studies that evaluated effects on pain , functional status or work ability . DATA COLLECTION AND ANALYSIS Two review authors independently selected trials for inclusion , extracted data and assessed risk of bias of the included studies . When studies were sufficiently similar , we performed statistical pooling of reported results . MAIN RESULTS We included 44 studies ( 62 publications ) with 6,580 participants that evaluated 25 different interventions . We categorised these interventions according to their working mechanisms into exercises , ergonomics , behavioural and other interventions .Overall , we judged 35 studies as having a high risk of bias mainly because of an unknown r and omisation procedure , lack of a concealed allocation procedure , unblinded trial participants or lack of an intention-to-treat analysis .We found very low- quality evidence showing that exercises did not improve pain in comparison with no treatment ( five studies , st and ardised mean difference ( SMD ) -0.52 , 95 % confidence interval ( CI ) -1.08 to 0.03 ) , or minor intervention controls ( three studies , SMD -0.25 , 95 % CI -0.87 to 0.37 ) or when provided as additional treatment ( two studies , inconsistent results ) at short-term follow-up or at long-term follow-up . Results were similar for recovery , disability and sick leave . Specific exercises led to increased pain at short-term follow-up when compared with general exercises ( four studies , SMD 0.45 , 95 % CI 0.14 to 0.75)We found very low- quality evidence indicating that ergonomic interventions did not lead to a decrease in pain when compared with no intervention at short-term follow-up ( three studies , SMD -0.07 , 95 % CI -0.36 to 0.22 ) but did decrease pain at long-term follow-up ( four studies , SMD -0.76 , 95 % CI -1.35 to -0.16 ) . There was no effect on disability but sick leave decreased in two studies ( risk ratio ( RR ) 0.48 , 95 % CI 0.32 to 0.76 ) . None of the ergonomic interventions was more beneficial for any outcome measures when compared with another treatment or with no treatment or with placebo . Behavioural interventions had inconsistent effects on pain and disability , with some subgroups showing benefit and others showing no significant improvement when compared with no treatment , minor intervention controls or other behavioural interventions .In the eight studies that evaluated various other interventions , there was no evidence of a clear beneficial effect of any of the interventions provided . AUTHORS ' CONCLUSIONS We found very low- quality evidence indicating that pain , recovery , disability and sick leave are similar after exercises when compared with no treatment , with minor intervention controls or with exercises provided as additional treatment to people with work-related complaints of the arm , neck or shoulder . Low- quality evidence also showed that ergonomic interventions did not decrease pain at short-term follow-up but did decrease pain at long-term follow-up . There was no evidence of an effect on other outcomes . For behavioural and other interventions , there was no evidence of a consistent effect on any of the outcomes . Studies are needed that include more participants , that are clear about the diagnosis of work-relatedness and that report findings according to current guidelines
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"OBJECTIVE To compare the effects of manual therapy and stretching exercise on neck pain and disability . DESIGN An examiner-blinded r and omized cross-over trial . PATIENTS A total of 125 women with non-specific neck pain . METHODS PATIENTS were r and omized into 2 groups . Group 1 received manual therapy twice weekly and Group 2 performed stretching exercises 5 times a week . After 4 weeks the treatments were changed . The follow-up times were after 4 and 12 weeks . Neck pain ( visual analogue scale ) and disability indices were measured . RESULTS Mean value ( st and ard deviation ) for neck pain was 50 mm ( 22 ) and 49 mm ( 19 ) at baseline in Group 1 and Group 2 , respectively , and decreased during the first 4 weeks by 26 mm ( 95 % Confidence Interval 20 - 33 ) and 19 mm ( 12 - 27 ) , respectively . There was no significant difference between groups . Neck and shoulder pain and disability index decreased significantly more in Group 1 after manual therapy ( p=0.01 ) as well as neck stiffness ( p=0.01 ) . CONCLUSION Both stretching exercise and manual therapy considerably decreased neck pain and disability in women with non-specific neck pain . The difference in effectiveness between the 2 treatments was minor . Low-cost stretching exercises can be recommended in the first instance as an appropriate therapy intervention to relieve pain , at least in the short-term",
"STUDY DESIGN A prospect i ve r and omized clinical trial . OBJECTIVE To compare the effectiveness of 2 physical therapy treatment approaches for impingement syndrome of the shoulder . BACKGROUND Manual physical therapy combined with exercise is a commonly applied but currently unproven clinical treatment for impingement syndrome of the shoulder . METHODS AND MEASURES Thirty men and 22 women ( age 43 years + /- 9.1 ) diagnosed with shoulder impingement syndrome were r and omly assigned to 1 of 2 treatment groups . The exercise group performed supervised flexibility and strengthening exercises . The manual therapy group performed the same program and received manual physical therapy treatment . Both groups received the selected intervention 6 times over a 3-week period . The testers , who were blinded to group assignment , measured strength , pain , and function before treatment and after 6 physical therapy visits . Strength was a composite score of isometric strength tests for internal rotation , external rotation , and abduction . Pain was a composite score of visual analog scale measures during resisted break tests , active abduction , and functional activities . Function was measured with a functional assessment question naire . The visual analog scale used to measure pain with functional activities and the functional assessment question naire were also measured 2 months after the initiation of treatment . RESULTS Subjects in both groups experienced significant decreases in pain and increases in function , but there was significantly more improvement in the manual therapy group compared to the exercise group . For example , pain in the manual therapy group was reduced from a pretreatment mean ( + /- SD ) of 575.8 ( + /- 220.0 ) to a posttreatment mean of 174.4 ( + /- 183.1 ) . In contrast , pain in the exercise group was reduced from a pretreatment mean of 557.1 ( + /- 237.2 ) to a posttreatment mean of 360.6 ( + /- 272.3 ) . Strength in the manual therapy group improved significantly while strength in the exercise group did not . CONCLUSION Manual physical therapy applied by experienced physical therapists combined with supervised exercise in a brief clinical trial is better than exercise alone for increasing strength , decreasing pain , and improving function in patients with shoulder impingement syndrome",
"OBJECTIVES The aim of this study was to investigate the effectiveness of an ergonomic intervention on productivity loss at work caused by upper-extremity disorders ( UED ) . METHODS Workers with medically verified UED were invited to participate . The intervention consisted of a physician contacting the worker 's supervisor and an occupational physiotherapist conducting an ergonomic assessment at the worksite . Before and after the intervention , the employees self-assessed UED-related productivity loss ( ie , decreased quality and quantity of the daily work output ) . We tested for differences between groups at 8 and sub-sequently 12 weeks . We also applied generalized estimating equation ( GEE ) to analyze repeated measures data . RESULTS Altogether 177 employees were r and omized . The overall participation rate was 88 % . At baseline , 54 % of the intervention group and 58 % of the control group reported productivity loss . The magnitude of productivity loss was 17 % and 20 % , respectively . At 8 weeks , both the proportion and magnitude of productivity loss were lower in the intervention than the control group , but the differences were statistically significant only at 12 weeks ( proportion 25 % versus 51 % , magnitude 7 % versus 18 % , P=0.001 for both ) . Using GEE analyses , we also found the differences to be statistically significant ( proportion 38 % versus 52 % , magnitude 12 % versus 18 % ) . The intervention only benefitted employees with 0 - 20 % loss of productivity at baseline , not those with a higher initial productivity loss . CONCLUSIONS Early ergonomic intervention , in addition to adequate medical care , is effective in preventing and restoring self-reported productivity loss associated with UED",
"Background Arm , shoulder and neck symptoms are very prevalent among computer workers . In an attempt to reduce these symptoms , a large occupational health service in the Netherl and s developed a preventive programme on exposure to risk factors , prevalence of arm , shoulder and neck symptoms , and sick leave in computer workers . The purpose of this study was to assess the effectiveness of this intervention programme . Methods The study was a r and omised controlled trial . The participants were assigned to either the intervention group or the usual care group by means of cluster r and omisation . At baseline and after 12 months of follow-up , the participants completed the RSI QuickScan question naire on exposure to the risk factors and on the prevalence of arm , shoulder and neck symptoms . A tailor-made intervention programme was proposed to participants with a high risk profile at baseline . Examples of implemented interventions are an individual workstation check , a visit to the occupational health physician and an education programme on the prevention of arm , shoulder and neck symptoms . The primary outcome measure was the prevalence of arm , shoulder and neck symptoms . Secondary outcome measures were the scores on risk factors for arm , shoulder and neck symptoms and the number of days of sick leave . Sick leave data was obtained from the companies . Multilevel analyses were used to test the effectiveness . Results Of the 1,673 persons invited to participate in the study , 1,183 persons ( 71 % ) completed the baseline question naire and 741 persons participated at baseline as well as at 12-month follow-up . At 12-month follow-up , the intervention group showed a significant positive change ( OR = 0.48 ) in receiving information on healthy computer use , as well as a significant positive change regarding risk indicators for work posture and movement , compared to the usual care group . There were no significant differences in changes in the prevalence of arm , shoulder and neck symptoms or sick leave between the intervention and usual care group . Conclusions The effects of the RSI QuickScan intervention programme were small , possibly as a result of difficulties with the implementation process of the proposed interventions . However , some significant positive effects were found as to an increase in receiving education and a decrease in exposure to adverse postures and movements . With regard to symptoms and sick leave , only small and non-significant effects were found . Trial registration Netherl and s National Trial Register",
"BACKGROUND This study exp and ed previous NIOSH-IRS research examining the effects of rest breaks and stretching exercises on symptoms and performance in data -entry workers . METHODS All workers spent 4 weeks with conventional breaks ( two 15 min breaks per day ) and 4 weeks with supplementary breaks ( two 15 min breaks plus four 5 min breaks per day ) . One-half were assigned at r and om to a group instructed to perform brief stretching exercises during breaks . The remainder comprised the \" no stretching \" ( control ) group . RESULTS 51 workers ( stretch group n = 21 ; no stretch group n = 30 ) completed the study symptom question naires . Discomfort and eyestrain were significantly lower with supplementary breaks , and supplementary breaks attenuated accumulation of discomfort and eyestrain during work sessions . Data -entry speed was significantly faster with supplementary breaks so that work output was maintained , despite replacing 20 min of work time with break time . In the stretch group , workers reported stretching during only 25 % of conventional breaks and 39 % of supplementary breaks , and no significant effects of stretching on discomfort or performance were observed . CONCLUSIONS These results provide further converging evidence that supplementary breaks reliably minimize discomfort and eyestrain without impairing productivity . Low compliance in performing stretches prevented valid assessment of stretching effects . Further research on stretching exercises and exercise compliance is warranted",
"Objective : To investigate the effect of two contrasting physical activity worksite interventions versus a reference intervention ( REF ) on various health outcomes . Methods : A 1-year r and omized controlled trial was conducted with specific resistance training ( SRT ) , all-round physical exercise ( APE ) , and REF . Results : SRT and APE compared with REF showed significant reductions in systolic blood pressure ( ∼6 mm Hg ) , body fat percentage ( ∼2.2 body fat% ) , as well as shoulder and back pain ( ∼30 % reduction in duration ) . Muscle strength ( APE and SRT ) and maximal oxygen uptake ( APE ) increased approximately 10 % . Conclusions : Worksite intervention with both SRT as well as APE is recommended , since these activities compared with REF result ed in clinical ly relevant reductions of cardiovascular and metabolic syndrome-related risk factors as well as musculoskeletal pain symptoms , in combination with minor increases in physical capacity",
"Rapid force capacity of chronically painful muscles is inhibited markedly more than maximal force capacity and is therefore relevant to assess in rehabilitation setting s. Our objective was to investigate the effect of two contrasting types of physical exercise on rapid force capacity , as well as neural and muscular adaptations in women with chronic neck muscle pain . A group of employed women ( n = 42 ) with a clinical diagnosis of trapezius myalgia participated in a 10-wk r and omized controlled trial ; specific strength training of the neck/shoulder muscles , general fitness training performed as leg-bicycling ; or a reference intervention without physical activity . Maximal voluntary shoulder abductions were performed at static angles of 35 degrees and 115 degrees with simultaneous recording of electromyography ( EMG ) in the trapezius and deltoid . Maximal muscle strength and activation ( peak torque and peak EMG ) as well as rapid muscle strength and activation [ rate of torque development ( RTD ) and rate of EMG rise ] were subsequently determined . Trapezius muscle fiber characteristics were determined with ATPase histochemistry . Significant changes were observed only in the specific strength training group . Whereas peak torque increased 18 - 29 % ( P RTD increased 61 - 115 % ( P Peak EMG and rate of EMG rise increased correspondingly ( P trapezius type II muscle fibers hypertrophied 20 % ( P rapid force capacity of chronically painful muscles is highly responsive to rehabilitation with specific strength training . The underlying mechanisms were related to both pain reduction and general neuromuscular adaptations to strength training . Potentially , the present method can be a useful clinical screening tool of muscle function in rehabilitation setting",
"UNLABELLED We investigated the effectiveness of cupping , a traditional method of treating musculoskeletal pain , in patients with carpal tunnel syndrome ( CTS ) in an open r and omized trial . n = 52 out patients ( 58.5 + /- 8.0 years ) with neurologically confirmed CTS were r and omly assigned to either a verum ( n = 26 ) or a control group ( n = 26 ) . Verum patients were treated with a single application of wet cupping , and control patients with a single local application of heat within the region overlying the trapezius muscle . Patients were followed up on day 7 after treatment . The primary outcome , severity of CTS symptoms ( VAS ) , was reduced from 61.5 + /- 20.5 to 24.6 + /- 22.7 mm at day 7 in the cupping group and from 67.1 + /- 20.2 to 51.7 + /- 23.9 mm in the control group [ group difference -24.5 mm ( 95%CI -36.1 ; -2.9 , P Levine CTS-score ( -.6 pts : 95%CI -.9 ; -.2 , P = .002 ) , neck pain ( -12.6 mm ; 95%CI -18.8 ; -6.4 , P functional disability ( DASH-Score ) ( -11.1 pts ; 95%CI -17.1 ; -5.1 , P physical quality of life ( .3 ; 95%CI .0 ; .3 , P = .048 ) . The treatment was safe and well tolerated . We conclude that cupping therapy may be effective in relieving the pain and other symptoms related to CTS . The efficacy of cupping in the long-term management of CTS and related mechanisms remains to be clarified . PERSPECTIVE The results of a r and omized trial on the clinical effects of traditional cupping therapy in patients with carpal tunnel syndrome are presented . Cupping of segmentally related shoulder zones appears to alleviate the symptoms of carpal tunnel syndrome",
"Objective : To investigate the effect of noxious level electrical stimulation on pain , grip strength and functional abilities in subjects with chronic lateral epicondylitis . Design : R and omized , placebo-control , double-blinded study . Setting : Physical Therapy Department , North Georgia College and State University . Subjects : Eighteen subjects with chronic lateral epicondylitis between the ages of 24 and 72 years participated in this study . Subjects were r and omly assigned into treatment or placebo groups . Interventions : Subjects received six sessions of low-frequency electrical stimulation over the palpated tender points . The intensity of electrical stimulation was set at 0 in the placebo group . Main measurements : Grip strength , functional status , pain intensity and limited activity due to pain were assessed before and after treatment . Six-month follow-up data were collected in treatment group only . Results : Both clinical ly and statistically significant improvements in average grip strength were found ( treatment group : 28 % increase ; placebo group : 2.5 % decrease ; P=0.04 ) , functional activity ( treatment group : 110 % increase ; placebo group : 22 % increase ; P= 0.003 ) , pain intensity ( treatment group : 3.1 point decrease ; placebo group : 0.2 point increase ; P=0.01 ) and activity limitation due to pain ( treatment group : 4.1 points increase ; placebo group : 1.9 point decrease ; P= 0.003 ) between the treatment and placebo groups . Follow-up data showed that 100 % of subjects maintained the improved function , and 83 % remained pain-free for at least six months post treatment . Conclusion : The results of this study indicated that symptoms of chronic lateral epicondylitis could be effectively treated by noxious level low-frequency electrical stimulation",
"OBJECTIVE To evaluate how an intervention program modifies the clinical course of work disability in musculoskeletal diagnoses . METHODS All patients with temporary work disability related to musculoskeletal disorders ( MSDs ) in 3 health districts of Madrid , Spain were r and omized into st and ard care ( control group ) or the intervention group . Intervention consisted of a specific program , run by rheumatologists , following detailed proceedings . Inclusion and followup lasted 12 months each . According to the cause , every temporary work disability episode was classified into 11 syndrome categories . For each we calculated efficacy , as the difference between groups in the number of days on sick leave per temporary work disability episode ; relative efficacy , or the percentage of days saved in the intervention group ; and time of maximum program effect . Analyses were performed on an intent-to-treat basis . Survival techniques were run and results were expressed as the hazard ratio ( HR ) in the intervention versus control group . RESULTS A total of 13,077 patients were included , generating 16,297 temporary work disability episodes . The most frequent cause was back pain . Temporary work disability episodes were significantly shorter in the intervention group than in the controls in all syndrome categories except knee pain ( excluding osteoarthritis ) . Program relative efficacy varied from 28 - 72 % . The program was highly efficacious in carpal tunnel syndrome ( HR 2.09 , 95 % confidence interval [ 95 % CI ] 1.17 - 3.75 ) , peripheral osteoarthritis ( HR 1.58 , 95 % CI 1.14 - 2.19 ) , and inflammatory diseases ( HR 1.52 , 95 % CI 1.09 - 2.12 ) . The maximum effect of the program always took place within the first 2 months . CONCLUSION The implementation of this type of specialist-run , protocol -based early intervention program would be very beneficial in the treatment of patients with work disability related to MSDs , except for those with knee pain ( excluding osteoarthritis )",
"This r and omized clinical trial evaluated the effects of keyboard keyswitch design on computer users with h and paresthesias . Twenty computer users were matched and r and omly assigned to keyboard A ( n = 10 ) or B ( n = 10 ) . The keyboards were of conventional layout and differed in keyswitch design . Various outcome measures were assessed during the 12 weeks of use . Subjects assigned keyboard A experienced a decrease in h and pain between weeks 6 and 12 when compared with keyboard B subjects ( P = 0.05 ) and demonstrated an improvement in the Phalen test time ( right h and , P = 0.006 ; left h and , P = 0.06 ) . Keyboard assignment had no significant effect on change in h and function or median nerve latency . We conclude that use of keyboard A for 12 weeks led to a reduction in h and pain and an improved physical examination finding when compared with keyboard B. There was no corresponding improvement in h and function or median nerve latency",
"Abstract Objective To determine the effectiveness of dynamic muscle training and relaxation training for chronic neck pain . Design R and omised controlled trial . Setting Five occupational healthcare centres , Tampere , Finl and . Participants 393 female office workers ( mean age 45 years ) with chronic non-specific neck pain r and omly assigned to 12 weeks of dynamic muscle training ( n = 135 ) or relaxation training ( n = 128 ) , plus one week of reinforcement training six months after baseline ; or ordinary activity ( control group ; n = 130 ) . Main outcome measure Change in intensity of neck pain at three , six , and 12 months . Results No significant difference was found in neck pain between the groups at follow up . However , the range of motion for cervical rotation and lateral flexion increased more in the training groups than in the control group . Conclusions Dynamic muscle training and relaxation training do not lead to better improvements in neck pain compared with ordinary activity",
"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",
"Introduction Return to work following an occupational injury is a multifactoral process although many traditional clinic-based rehabilitation programs do not appreciate the importance of workplace factors . A r and omized controlled trial was conducted to investigate the effect of workplace-based rehabilitation program on the return to work outcome of work-related rotator cuff disorder , which is based on the therapeutic use of actual work facilities and work environment . Methods A total of 103 workers were recruited and r and omly assigned into Clinic-based Work Hardening ( CWH ) or Workplace-based Work Hardening ( WWH ) groups . The CWH group were given traditional generic work hardening training while WWH group received workplace-based work hardening training with rehabilitative principles of athletic rotator cuff pathology , biomechanics and specific job activities . Results After four weeks , a higher return to work rate was obtained in WWH group compared to CWH group ( 71.4 % vs. 37 % , p lowering of self-reported shoulder problems and functional work capabilities in the WWH group versus the CWH group . Conclusion Workplace-based rehabilitation program appeared to be more effective in facilitating the return to work process of the injured worker as assessed immediately following intervention . In particular this approached was associated with many of the psychosocial workplace factors related to separation from the work routine . The influence of peer group and /or employer could be minimized . This initial attempt with rotator cuff injuries appears promising however long-term outcome needs to be determined",
"Purpose The aim of the study was to determine effects of ergonomic intervention on work-related upper extremity musculoskeletal disorders ( WUEMSDs ) among computer workers . Methods Four hundred computer workers answered a question naire on work-related upper extremity musculoskeletal symptoms ( WUEMSS ) . Ninety-four subjects with WUEMSS using computers at least 3 h a day participated in a prospect i ve , r and omized controlled 6-month intervention . Body posture and workstation layouts were assessed by the Ergonomic Question naire . We used the Visual Analogue Scale to assess the intensity of WUEMSS . The Upper Extremity Function Scale was used to evaluate functional limitations at the neck and upper extremities . Health-related quality of life was assessed with the Short Form-36 . After baseline assessment , those in the intervention group participated in a multicomponent ergonomic intervention program including a comprehensive ergonomic training consisting of two interactive sessions , an ergonomic training brochure , and workplace visits with workstation adjustments . Follow-up assessment was conducted after 6 months . Results In the intervention group , body posture ( p workstation layout ( p = 0.002 ) improved over 6 months ; furthermore , intensity ( p duration ( p frequency ( p = 0.009 ) of WUEMSS decreased significantly in the intervention group compared with the control group . Additionally , the functional status ( p = 0.001 ) , and physical ( p and mental ( p = 0.035 ) health-related quality of life improved significantly compared with the controls . There was no improvement of work day loss due to WUEMSS ( p > 0.05 ) . Conclusions Ergonomic intervention programs may be effective in reducing ergonomic risk factors among computer workers and consequently in the secondary prevention of WUEMSDs",
"Background Neck and upper limb symptoms are frequently reported by computer workers . Work style interventions are most commonly used to reduce work-related neck and upper limb symptoms but lifestyle physical activity interventions are becoming more popular to enhance workers health and reduce work-related symptoms . A combined approach targeting work style and lifestyle physical activity seems promising , but little is known on the effectiveness of such combined interventions . Methods / design The RSI@Work study is a r and omised controlled trial that aims to assess the added value of a lifestyle physical activity intervention in addition to a work style intervention to reduce neck and upper limb symptoms in computer workers . Computer workers from seven Dutch companies with frequent or long-term neck and upper limb symptoms in the preceding six months and /or the last two weeks are r and omised into three groups : ( 1 ) work style group , ( 2 ) work style and physical activity group , or ( 3 ) control group . The work style intervention consists of six group meetings in a six month period that take place at the workplace , during work time , and under the supervision of a specially trained counsellor . The goal of this intervention is to stimulate workplace adjustment and to improve body posture , the number and quality of breaks and coping behaviour with regard to high work dem and s. In the combined ( work style and physical activity ) intervention the additional goal is to increase moderate to heavy physical activity . The control group receives usual care . Primary outcome measures are degree of recovery , pain intensity , disability , number of days with neck and upper limb symptoms , and number of months without neck and upper limb symptoms . Outcome measures will be assessed at baseline and six and 12 months after r and omisation . Cost-effectiveness of the group meetings will be assessed using an employer 's perspective . Discussion This study will be one of the first to assess the added value of a lifestyle physical activity intervention in addition to a work style intervention in reducing neck and upper limb symptoms of computer workers . The results of the study are expected in 2007",
"& NA ; This study examined the relative effectiveness of EMG biofeedback , applied relaxation training and a combined procedure in the management of chronic , upper extremity cumulative trauma disorder . Forty‐eight patients with a history of about 5–6 years of upper extremity pain were r and omly assigned to 1 of 4 treatment conditions , namely applied relaxation training , EMG biofeedback , a combined approach or a wait‐list control . Treatments were conducted on an individual basis , twice per week for 4 weeks . Patients in all 3 treatment conditions showed significant short‐term reductions in pain and psychopathology in comparison to the wait‐list group who showed minimal change . Six‐month follow‐up data were obtained for patients in the treatment conditions , but not the wait‐list group . There was some evidence of relapse on measures Of depression , anxiety and pain beliefs for treated patients during the 6‐month follow‐up period , although measures remained significantly below pre‐treatment levels for most outcome indices . Self‐monitored pain continued to decrease for the treatment groups through follow‐up . Contrary to predictions , however , the strongest short‐term treatment benefits were shown by patients receiving applied relaxation training on measures of pain , distress , interference in daily living , depression and anxiety . By 6‐month follow‐up , differences between treatment groups were no longer evident",
"Background Exercise therapies generate substantial costs in computer workers with non-specific work-related upper limb disorders ( WRULD ) . Aims To study if postural exercise therapy is cost-effective compared to regular physiotherapy in screen-workers with early complaints , both from health care and societal perspective . Methods Prospect i ve r and omized trial including cost-effectiveness analysis ; one year follow-up . Participants : Eighty-eight screen-workers with early non-specific WRULD ; six drop-outs . Interventions : A ten week postural exercise program versus regular physiotherapy . Outcome measures : Effectiveness measures : Pain : visual analogous scale ( VAS ) , self-perceived WRULD ( yes/no ) . Functional outcome : Disabilities of Arm , Shoulder and H and - Dutch Language Version ( DASH-DLV ) . Quality of life outcome : EQ-5D.Economic measures : health care costs including patient and family costs and productivity costs result ing in societal costs . Cost-effectiveness measures : health care costs and societal costs related to the effectiveness measures . Outcome measures were assessed at baseline ; three , six and twelve months after baseline . Results At baseline both groups were comparable for baseline characteristics except scores on the Pain Catastrophizing Scale and comparable for costs . No significant differences between the groups concerning effectiveness at one year follow-up were found . Effectiveness scores slightly improved over time . After one year 55 % of participants were free of complaints . After one year the postural exercise group had higher mean total health care costs , but lower productivity costs compared to the physiotherapy group . Mean societal costs after one year ( therefore ) were in favor of postural exercise therapy [ - € 622 ; 95 % CI -2087 ; + 590 ) ] . After one year , only self- perceived WRULD seemed to result in acceptable cost-effectiveness of the postural exercise strategy over physiotherapy ; however the probability of acceptable cost-effectiveness did not exceed 60%.Considering societal costs related to QALYs , postural exercise therapy had a probability of over 80 % to be cost-effective over a wide range of cost-effectiveness ceiling ratios ; however based on a marginal QALY-difference of 0.1 over a 12 month time frame . Conclusion Although our trial failed to find significant differences in VAS , QALYs and ICERs based on VAS and QALYs at one-year follow-up , CEACs suggest that postural exercise therapy according to Mensendieck/Cesar has a higher probability of being cost-effective compared to regular physiotherapy ; however further research is required . Trial registration IS RCT N",
"To compare training programs for women with trapezius myalgia regarding physical performance and pain , 102 women were r and omized to strength , endurance , co-ordination and non-training groups . Before and after the intervention , static strength and dynamic muscular endurance in shoulder muscles were measured on a Cybex II dynamometer . Muscle activity in shoulder muscles was monitored via surface EMG . The signal amplitude ratio between the active and passive phase of repeated contractions indicated the ability to relax . Pain at present , pain in general and pain at worst were measured on visual analogue scales . After training , within group comparisons showed that the training groups rated less pain , and in the strength training group ratings of pain at worst differed from the non-training group . Using the non-training group as a reference , static strength increased in the strength and endurance training groups and muscular endurance in all training groups . The study indicates that regular exercises with strength , endurance or co-ordination training of neck/shoulder muscles might alleviate pain for women with work-related trapezius myalgia",
"Objective : To investigate the effects of ambulant myofeedback training including ergonomic counselling ( Mfb ) and ergonomic counselling alone ( EC ) , on work-related neck-shoulder pain and disability . Methods : Seventy-nine female computer workers reporting neck-shoulder complaints were r and omly assigned to Mfb or EC and received four weeks of intervention . Pain intensity in neck , shoulders , and upper back , and pain disability , were measured at baseline , immediately after intervention , and at three and six months follow-up . Results : Pain intensity and disability had significantly decreased immediately after four weeks Mfb or EC , and the effects remained at follow up . No differences were observed between the Mfb and EC group for outcome and subjects in both intervention groups showed comparable chances for improvement in pain intensity and disability . Conclusions : Pain intensity and disability significantly reduced after both interventions and this effect remained at follow-up . No differences were observed between the two intervention groups",
"The theoretical framework is that muscle tension in the neck is related to insufficient muscular rest and is a risk factor for chronic pain and reduced work ability . Promoting muscle strength and muscle rest may increase work ability and reduce neck pain . Objectives To test whether myofeedback training or intensive strength training leads to decreased pain and increased work ability in women on long-term sick leave . Methods This is a r and omized controlled trial of two 1-month interventions with myofeedback or muscular strength training in the home environment . Female human service organization workers ( n = 60 ) on long-term ( > 60 days ) sick leave and with chronic neck pain were followed with self-reported and laboratory-observed data of health , pain , muscular activation , and work ability , at baseline , immediately after the intervention and 3 months after baseline . Results For both intervention groups , pain was lowered over time compared with the control group . Decreased pain and muscular activity was associated with increased self-rated work ability and with laboratory-observed work ability at 3-month follow-up . Decreased pain was also associated with increased self-rated work ability at 1-month follow-up . Muscular strength training was associated with increased self-rated work ability and mental health . Myofeedback was associated with increased observed work ability and self- rated vitality . Conclusions The two interventions showed positive results , suggesting that they could be developed for use in health care practice to address pain and work ability . The intensive muscular strength training program , which is both easy to conduct at home and easy to coach , was associated with increased work ability",
"QUESTION Are postural exercises delivered by Mensendieck/Cesar therapists more effective in decreasing pain , reducing disability and improving health-related quality of life in visual display unit workers with early non-specific work-related upper limb disorders than strength and fitness exercises delivered by physiotherapists ? DESIGN R and omised trial with concealed allocation and intention-to-treat analysis . PARTICIPANTS Eighty-eight ( 6 drop-outs ) visual display unit workers with early non-specific work-related upper limb disorders . INTERVENTION One group received 10 weeks of postural exercises while the other group received 10 weeks of strength and fitness exercises . OUTCOME MEASURES Pain was measured with a 10-cm visual analogue scale , disability was measured with the Disabilities of Arm , Shoulder and H and question naire , and health-related quality of life was measured with the Short Form-36 . Number of participants experiencing upper limb complaints was also collected . Outcome measures were collected at baseline and again at 3 , 6 , and 12 months . RESULTS There was no significant difference in decrease in pain between the groups at 3 months ( 0.6 cm , 95 % CI 0.0 to 1.2 ) , 6 months ( 0.2 , 95 % CI -0.3 to 0.7 ) , or at 12 months ( 0.1 , 95 % CI -0.6 to 0.8 ) . Differences between the groups in upper limb complaints , disability , and health related quality of life were also small and not significant at any measurement occasion . CONCLUSION Postural exercises did not result in a better outcome than strength and fitness exercises . However , 55 % of visual display unit workers with early non-specific work-related upper limb disorders reported being free of complaints one year after both interventions were commenced . TRIAL REGISTRATION IS RCT N15872455",
"Background Although leisure-time physical activity is important for health , adherence to regular exercise is challenging for many adults . The workplace may provide an optimal setting to reach a large proportion of the adult population needing regular physical exercise . This study evaluates the effect of implementing strength training at the workplace on non-specific neck and shoulder pain among industrial workers . Methods Cluster-r and omized controlled trial involving 537 adults from occupations with high prevalence of neck and shoulder pain ( industrial production units ) . Participants were r and omized to 20 weeks of high-intensity strength training for the neck and shoulders three times a week ( n = 282 ) or a control group receiving advice to stay physically active ( n = 255 ) . The strength training program followed principles of progressive overload and periodization . The primary outcome was changes in self-reported neck and shoulder pain intensity ( scale 0 - 9 ) . Results 85 % of the participants followed the strength training program on a weekly basis . In the training group compared with the control group , neck pain intensity decreased significantly ( -0.6 , 95 % CI -1.0 to -0.1 ) and shoulder pain intensity tended to decrease ( -0.2 , 95 % CI -0.5 to 0.1 , P = 0.07 ) . For pain-cases at baseline ( pain intensity > = 3 ) the odds ratio - in the training group compared with the control group - for being a non-case at follow-up ( pain intensity High-intensity strength training relying on principles of progressive overload can be successfully implemented at industrial workplaces , and results in significant reductions of neck and shoulder pain . Trial registration NCT01071980",
"OBJECTIVES This study evaluated the effects on work-related neck and upper-limb disorders among computer workers stimulated ( by a software program ) to take regular breaks and perform physical exercises . Possible effects on sick leave and productivity were studied as well . A r and omized controlled design was used with cluster r and omization . Altogether 268 computer workers with complaints in the neck or an upper limb from 22 office locations were r and omized into a control group , one intervention group stimulated to take extra breaks and one intervention group stimulated to perform exercises during the extra breaks during an 8-weekperiod . Question naires were administered before and after the intervention , and questions were generated by the software during the intervention period . Computer usage was recorded online . RESULTS The data on self-reported recovery suggested a favorable effect ; more subjects in the intervention groups than in the control group reported recovery ( 55 % versus 34 % ) from their complaints and fewer reported deterioration ( 4 % versus 20 % ) . However , a comparison between the reported pre- and postintervention scores on the severity and frequency of the complaints showed no significant differences in the change among the three groups . No effects on sick leave were observed . The subjects in the intervention groups showed higher productivity . CONCLUSIONS The use of a software program stimulating workers to take regular breaks contributes to perceived recovery from neck or upper-limb complaints . There seems to be no additional effects from performing physical exercises during these breaks",
"OBJECTIVES To compare the effects of biofeedback with those of active exercise and passive treatment in treating work-related neck and shoulder pain . DESIGN A r and omized controlled trial with 3 intervention groups and a control group . SETTING Participants were recruited from outpatient physiotherapy clinics and a local hospital . PARTICIPANTS All participants reported consistent neck and shoulder pain related to computer use for more than 3 months in the past year and no severe trauma or serious pathology . A total of 72 potential participants were recruited initially , of whom a smaller group of individuals ( n=60 ) completed the r and omized controlled trial . INTERVENTIONS The 3 interventions were applied for 6 weeks . In the biofeedback group , participants were instructed to use a biofeedback machine on the bilateral upper trapezius ( UT ) muscles daily while performing computer work . Participants in the exercise group performed a st and ardized exercise program daily on their own . In the passive treatment group , interferential therapy and hot packs were applied to the participants ' necks and shoulders . The control group was given an education booklet on office ergonomics . MAIN OUTCOME MEASURES Pain ( visual analog scale ) , neck disability index ( NDI ) , and surface electromyography were assessed preintervention and postintervention . Pain and NDI were reassessed after 6 months . RESULTS Postintervention , average pain and NDI scores were reduced significantly more in the biofeedback group than in the other 3 groups , and this was maintained at 6 months . Cervical erector spinae muscle activity showed significant reductions postintervention in the biofeedback group , and there were consistent trends of reductions in the UT muscle activity . CONCLUSIONS Six weeks of biofeedback training produced more favorable outcomes in reducing pain and improving muscle activation of neck muscles in patients with work-related neck and shoulder pain",
"The study examined the effectiveness of behaviorally-induced vasodilation ( hypnosis with biofeedback and autogenics ) in the treatment of upper extremity repetitive strain injuries ( RSI ) . Thirty patients with recent onset of upper extremity RSI symptoms were r and omly assigned to 1 of 2 treatment conditions , i.e. , hypnotically-induced vasodilation or a waiting-list control . Treatments were given on an individual basis , once a week for 6 weeks . Patients in the treatment condition showed highly significant increases in h and temperature between pre- and post-treatment . Patients in the treatment condition also showed highly significant reductions in pain in comparison to the waiting list condition",
"Study Design . Cluster r and omized controlled trial with 6 and 8 quarters of follow-up . Objective . To test the effects of giving evidence -based information addressing psychosocial risk factors for pain-related disability and of screening workplaces for physical health hazards at work on reducing new episodes and duration of pain-related and general absence taking . Summary of Background Data . The “ flag strategy ” for h and ling low back pain problems is recommended in many Western countries but , so far , r and omized intervention studies addressing psychosocial risk factors for disability related to low back pain show mixed results . Methods . We followed employees from 39 different work sites in western Denmark , who had received interventions consisting of either a carefully prepared booklet providing evidence -based information on common musculoskeletal pain problems alone or in combination with systematic workplace screening for physical work hazards . Absence due to pain for at least 7 days and the cumulative numbers of absence days were the main outcome measures . General absence taking was analyzed , too . Company registration s of sickness absence in combination with self-report on the cause of a given absence spell was used to inform absence spells . Results . A total of 3808 of 4006 eligible employees provided information . Among 1063 participants in the control arm , 1458 in the information arm , and 1287 in the information and workplace screening arm , 4.6 % , 6.9 % , and 4.6 % , respectively , experienced pain-related absence , and 27.8 % , 27.2 % , and 24.0 % , respectively , experienced general absence taking during follow-up . No positive effect on the risk of the 2 measures of absence or on the cumulative duration of absence among cases was seen . Conclusion . Results did not support population -based interventions addressing psychosocial risk factors for pain-related disability alone or in combination with workplace screening as effective in reducing the risk of pain-related absence taking or the duration of absence",
"Study Design . A prospect i ve r and omized clinical trial was conducted . Objective . To evaluate the long-term effects of three training interventions on women with work-related trapezius myalgia . Summary of Background Data . Studies with long-term follow-up evaluation of interventions for neck pain are scarce and usually cover fewer than 12 months . Methods . For this study , 126 women with work-related trapezius myalgia were r and omized into strength , muscular endurance , or coordination training or into a nontraining reference group . Intervention training occurred three times a week for 10 weeks . Assessment of pain intensity , pressure pain thresholds , symptom frequency , perceived health , and work and exercise habits was performed before and immediately after interventions , then at clinical examinations 8 months and 17 months after the interventions . Participation rates at these follow-up assessment s were 84 % and 81 % . At 3 years after the interventions , a question naire was answered by 94 % of the participants , 17 of whom were dropouts that never participated in any of the four intervention groups . Results . All the training programs showed similar pain reducing effects immediately after the interventions . Pain reductions were maintained at follow-up evaluations , but at the 8-month follow-up assessment , there were no differences between the training groups and the reference group on any variable . At 3 years after the interventions , the intervention groups did not differ from the dropout group . Almost half ( 49 % ) of the women had persistent symptoms at the 3-year follow-up assessment . Conclusions . The long-term effect of all the training programs was low . Pain in neck and shoulder muscles was persistent in a large proportion of the women over the 3 years",
"Introduction The goal of this study was to assess the effectiveness of a group-based interactive work style intervention in improving work style behavior . Methods Computer workers with neck and upper limb symptoms were r and omised into the work style group ( WS , N = 152 ) , the work style and physical activity group ( WSPA , N = 156 ) , or the usual care group ( N = 158 ) . Both intervention groups received the same work style intervention but the WSPA group also received a lifestyle physical activity intervention . Participants from the intervention groups attended six group meetings which focused on behavioral change with regard to body posture and workstation adjustment , breaks , and coping with high work dem and s in order to reduce work stress . Stage of change , breaks and exercise behavior , and stress outcomes were assessed by question naire at baseline ( T0 ) and after 6 ( T1 ) and 12 months ( T2 ) . Body posture and workstation adjustment were assessed by observation and by question naire at T0 , T1 , and T2 . Multilevel analyses were used to study differences in work style behavior between study groups . Results The work style intervention was effective in improving stage of change with regard to body posture , workstation adjustment , and the use of sufficient breaks during computer work . These findings were confirmed by higher self-reported use of breaks and exercise reminder software and less working hours without breaks . However , self-reported changes in body posture and workstation adjustment were less consistent . The work style intervention was ineffective in changing stress outcomes . Conclusion A group-based work style intervention seems to be effective in improving some elements of work style behavior . Future studies should investigate the effectiveness of work style interventions on all dimensions of the Feuerstein work style model",
"Abstract This study assessed the effectiveness of a single intervention targeting work style and a combined intervention targeting work style and physical activity on the recovery from neck and upper limb symptoms . Computer workers with frequent or long‐term neck and upper limb symptoms were r and omised into the work style group ( WS , n = 152 ) , work style and physical activity group ( WSPA , n = 156 ) , or usual care group ( n = 158 ) . The WS and WSPA group attended six group meetings . All meetings focused on behavioural change with regard to body posture , workplace adjustment , breaks and coping with high work dem and s ( WS and WSPA group ) and physical activity ( WSPA group ) . Pain , disability at work , days with symptoms and months without symptoms were measured at baseline and after 6 ( T1 ) and 12 months ( T2 ) . Self‐reported recovery was assessed at T1/T2 . Both interventions were ineffective in improving recovery . The work style intervention but not the combined intervention was effective in reducing all pain measures . These effects were present in the neck/shoulder , not in the arm/wrist/h and . For the neck/shoulder , the work style intervention group also showed an increased recovery‐rate . Total physical activity increased in all study groups but no differences between groups were observed . To conclude , a group‐based work style intervention focused on behavioural change was effective in improving recovery from neck/shoulder symptoms and reducing pain on the long‐term . The combined intervention was ineffective in increasing total physical activity . Therefore we can not draw conclusions on the effect of increasing physical activity on the recovery from neck and upper limb symptoms",
"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",
"Objectives To evaluate the cost-effectiveness of a work style ( WS ) intervention and a work style plus physical activity ( WSPA ) intervention in computer workers with neck and upper limb symptoms compared with usual care . Methods An economic evaluation was conducted from an employer 's perspective and alongside a r and omised controlled trial in which 466 computer workers with neck and upper limb symptoms were r and omised to a WS group ( N=152 ) , a WSPA group ( N=156 ) or a usual care group ( N=158 ) . Total costs were compared to the effects on recovery and pain intensity . In the primary analyses , missing effect data were imputed using multiple imputation techniques . Results Total costs during the 12-month intervention and follow-up period were € 1907 ( WS ) , € 2811 ( WSPA ) and € 2310 ( usual care ) . Differences between groups were not statistically significant . Neither intervention was more effective than usual care in improving overall recovery . The WS intervention was more effective than usual care in reducing current pain , average pain and worst pain in the past 4 weeks , but the WSPA intervention was not . The acceptability curve showed that when a company is willing to pay approximately € 900 for a 1-point reduction in average pain ( scale from 0 to 10 ) , the probability of cost-effectiveness compared to usual care is 95 % . Similar results were observed for current and worst pain . Conclusions This study shows that the WS intervention was not cost-effective for improving recovery but was cost-effective for reducing pain intensity , although this reduction was not clinical ly significant . The WSPA intervention was not cost-effective compared with usual care . Trial registration number IS RCT N87019406",
"OBJECTIVES To identify predictors of non-recovery in non-traumatic complaints at the arm , neck and shoulder in general practice 6 months after the first consultation . METHODS A prospect i ve cohort study was set in 21 Dutch general practice s. Consulters with a first or new episode of non-traumatic arm , neck or shoulder complaints and age 18 through 64 yrs entered the cohort . Complaint , patient , physical , psychosocial and work characteristics were investigated as possible predictors of non-recovery at 6 months using multiple logistic regression analyses ( backward Wald ) . RESULTS At 6 months , 46 % of the total population ( n = 612 ) and 42 % of the working sub population ( n = 473 ) still reported complaints . Complaint characteristics ( long duration of the complaint before consultation , recurrent complaint , musculoskeletal comorbidity and complaint mainly located at wrist or h and ) were most predictive of non-recovery followed by psychosocial characteristics ( more somatization and experiencing less social support ) . Having a specific diagnosis was associated with recovery . In the working sub population , the same variables were predictors of non-recovery . Additionally , low supervisory support was associated with non-recovery . The models correctly classified 72 - 75 % of the patients ( explained variance 0.27 - 0.28 ) . CONCLUSIONS Besides questions on complaint characteristics , information on somatization and support can help a general practitioner to recognize patients at risk of persistent complaints",
"& NA ; Amitriptyline is sometimes used to treat arm pain related to repetitive use , but rigorous evidence of its benefit is lacking . This r and omized controlled trial investigated whether amitriptyline provided greater pain relief or improved arm function than a placebo pill in adults with arm pain associated with repetitive use that had persisted for at least 3 months . Participants ( N = 118 ) were r and omly assigned to receive 25 mg of amitriptyline or a placebo pill for 6 weeks . The primary outcome was intensity of pain ( 10‐point numerical rating scale ) and secondary outcomes were arm symptoms , arm function , grip strength , mood , and sleep . Assessment s were done at baseline , 3 and 6 weeks of treatment , and 1 month after the treatment ended . Changes in arm pain were not statistically significant . However , the amitriptyline group improved more than the placebo group in arm function ( p = 0.023 ) and sense of well being ( p = 0.034 ) . In a longitudinal analysis , the amitriptyline group 's arm function score improved 0.45 points per week faster than placebo after adjusting for subject characteristics ( p = 0.015 ) . At the treatment 's midpoint , the amitriptyline group reported more “ troublesome side‐effects ” than the placebo group ( 52.5 % vs. 27.1 % , p = 0.005 ) , but this difference decreased by the end of the treatment ( 30.5 % vs. 22.0 % , p = 0.30 ) . The most frequent side effect was drowsiness . In conclusion , this study found that low‐dose amitriptyline did not significantly decrease arm pain among these participants but did significantly improve arm function and well being . Future research is needed to explore the effects of higher doses and longer duration of treatment",
"Work Related Musculoskeletal Disorders ( WMSDs ) among office workers with intensive computer use is widespread and the prevalence of symptoms is growing . This r and omized controlled trial investigated the effects of an office ergonomics training combined with a sit-st and workstation on musculoskeletal and visual discomfort , behaviors and performance . Participants performed a lab-based customer service job for 8 h per day , over 15 days and were assigned to : Ergonomics Trained ( n = 11 ) or Minimally Trained ( n = 11 ) . The training consisted of : a 1.5-h interactive instruction , a sit/st and practice period , and ergonomic reminders . Ergonomics Trained participants experienced minimal musculoskeletal and visual discomfort across the 15 days , varied their postures , with significantly higher performance compared to the Minimally Trained group who had a significantly higher number of symptoms , suggesting that training plays a critical role . The ability to mitigate symptoms , change behaviors and enhance performance through training combined with a sit-st and workstation has implication s for preventing discomforts in office workers",
"This study investigated effects of physical exercise on musculoskeletal pain symptoms in all regions of the body , as well as on other musculoskeletal pain in association with neck pain . A single blind r and omized controlled trial testing a one-year exercise intervention was performed among 549 office workers ; specific neck/shoulder resistance training , all-round physical exercise , or a reference intervention . Pain symptoms were determined by question naire screening of twelve selected body regions . Case individuals were identified for each body region as those reporting pain intensities at baseline of 3 or more ( scale of 0 - 9 ) during the last three months . For neck cases specifically , the additional number of pain regions was counted . Intensity of pain decreased significantly more in the neck , low back , right elbow and right h and in cases of the two exercise groups compared with the reference group ( P number of pain regions in neck cases decreased in the two exercise groups only ( P individuals with no or minor pain at baseline , development of pain was minor in all three groups . In conclusion , both specific resistance training and all-round physical exercise for office workers caused better effects than a reference intervention in relieving musculoskeletal pain symptoms in exposed regions of the upper body",
"PURPOSE To examine the dose-response relationship of specific strength- and endurance-training regimes for the cervical muscles , which have been shown to be effective among women with chronic neck pain and disability . METHODS A total of 180 female office workers , aged 25 to 53 yr , with chronic neck pain and disability were r and omized into a strength-training , an endurance-training , and a control group . The training groups participated in a 12-d rehabilitation period , in which instructions for the exercises were given by an experienced physical therapist . Both training groups continued with exercises at home for 12 months . Physical activity was measured with a training diary and a 1-month all-time recall question naire . All activities were registered and converted into metabolic equivalents ( METs ) . RESULTS Specific neck , shoulder , and upper-extremity training for more than 8.75 MET.h.wk was an effective training dose for decreasing neck pain . One MET-hour of training per week accounted for an 0.8-mm decrease of neck pain on a visual analog scale ( VAS ) and a 0.5-mm decrease on a disability index . Both strength and endurance training decreased perceived neck pain and disability . Declines in neck pain and disability correlated positively with the amount of specific training . CONCLUSION This study revealed that the described specific exercise protocol s were associated with decreases in chronic neck pain and disability . The effective dose of training was feasible and safe to perform among female office workers",
"In this study 169 female office employees were interviewed and examined to determine the occurrence and severity of neck and shoulder symptoms . Forty-seven of those with symptoms who fulfilled the criteria taken as indicating need for treatment were enrolled in a controlled clinical trial and divided into two groups . One group participated in dynamic muscle training of neck and shoulder muscles ( active physiotherapy ) . The other patients were treated by means of surface heat , massage , and stretching ( passive physiotherapy ) . Pain in the neck and shoulder regions disappeared significantly more often just after active treatment as compared to passive treatment . Symptoms returned within three months in both groups . However , after 12 months , the incidence of headache was significantly less in the group that had received active physiotherapy . Maximal isometric muscle strength in relation to cervical lateral flexion and extension and grip strength and endurance force of shoulder muscles improved significantly after active physiotherapy , but only maximal isometric extension force increased significantly after passive physiotherapy . Numbers of tender points in neck and shoulder muscles decreased significantly after both types of physiotherapy . Pressure threshold levels increased but not significantly in both groups during treatment",
"Objective : To determine the effectiveness and cost-effectiveness of a return-to-work outpatient multidisciplinary treatment programme for sick-listed workers with non-specific upper extremity musculoskeletal complaints . Methods : A r and omized controlled trial with a 1-year follow-up was carried out . Thirty-eight subjects were allocated to multidisciplinary treatment ( intervention , n=23 ) , or to usual care provided by occupational health services ( n=15 ) . The intervention consisted of psychological and physical sessions provided by a medical specialist , a psychologist , a physiotherapist and an occupational therapist . It aims at reconditioning , “ de-medicalizing ” , unrestrained moving and return-to-work . The intervention process was evaluated on compliance to the protocol and the effectiveness of its components . The individual outcome variable was the severity of complaints . The societal outcomes included return-to-work and costs . Measurements were performed at baseline and after 2 , 6 and 12 months . Mixed model analyses were used for analysis . Results : The intervention achieves its aims : physical disabilities ( P=0.039 ) , kinesiophobia ( P physical functioning ( P=0.016 ) improved significantly as compared to usual care . In addition , the intervention was significantly more effective in reducing the severity of complaints than usual care . The intervention was equally effective compared to usual care in terms of return-to-work ( 86 % in the intervention group vs. 73 % in the usual care group ) . The extra total costs and the extra gains in terms of return-to-work were not significantly higher for the intervention as compared to usual care after 12 months . Conclusion : Multidisciplinary treatment affects individuals positively , but shows no significant difference in ( cost- ) effectiveness on the societal level as compared to usual care",
"OBJECTIVE The prevalence of neck muscle pain has steadily increased and especially pain from the descending part of the trapezius muscle has been associated with monotonous work tasks such as computer work . Physical exercise is generally recommended as treatment , but it is unclear which type of training is most effective . Our objective was to determine the effectiveness of specific strength training of the painful muscle versus general fitness training without direct involvement of the painful muscle ( leg bicycling ) on work-related neck muscle pain . METHODS We conducted a r and omized controlled trial and recruited subjects from 7 workplaces characterized by monotonous jobs ( e.g. , computer-intensive work ) . Forty-eight employed women with chronic neck muscle pain ( defined as a clinical diagnosis of trapezius myalgia ) were r and omly assigned to 10 weeks of specific strength training locally for the affected muscle , general fitness training performed as leg bicycling with relaxed shoulders , or a reference intervention without physical activity . The main outcome measure was an acute and prolonged change in intensity of neck muscle pain ( 100-mm visual analog scale [ VAS ] ) . RESULTS A decrease of 35 mm ( approximately 79 % ; P VAS pain score over a 10-week period was seen with specific strength training , whereas an acute and transient decrease in pain ( 5 mm ; P general fitness training . CONCLUSION Specific strength training had high clinical relevance and led to marked prolonged relief in neck muscle pain . General fitness training showed only a small yet statistically significant acute pain reduction",
"A quantitative systematic review , or meta- analysis , uses statistical methods to combine the results of multiple studies . Meta-analyses have been done for systematic review s of therapeutic trials , diagnostic test evaluations , and epidemiologic studies . Although the statistical methods involved may at first appear to be mathematically complex , their purpose is simple : They are trying to answer four basic questions . Are the results of the different studies similar ? To the extent that they are similar , what is the best overall estimate ? How precise and robust is this estimate ? Finally , can dissimilarities be explained ? This article provides some guidance in underst and ing the key technical aspects of the quantitative approach to these questions . We have avoided using equations and statistical notations ; interested readers will find implementations of the described methods in the listed references . We focus here on the quantitative synthesis of reports of r and omized , controlled , therapeutic trials because far more meta-analyses on therapeutic studies than on other types of studies have been published . For practical reasons , we present a stepwise description of the tasks that are performed when statistical methods are used to combine data . These tasks are 1 ) deciding whether to combine data and defining what to combine , 2 ) evaluating the statistical heterogeneity of the data , 3 ) estimating a common effect , 4 ) exploring and explaining heterogeneity , 5 ) assessing the potential for bias , and 6 ) presenting the results . Deciding Whether To Combine Data and Defining What To Combine By the time one performs a quantitative synthesis , certain decisions should already have been made about the formulation of the question and the selection of included studies . These topics were discussed in two previous articles in this series [ 1 , 2 ] . Statistical tests can not compensate for lack of common sense , clinical acumen , and biological plausibility in the design of the protocol of a meta- analysis . Thus , a reader of a systematic review should always address these issues before evaluating the statistical methods that have been used and the results that have been generated . Combining poor- quality data , overly biased data , or data that do not make sense can easily produce unreliable results . The data to be combined in a meta- analysis are usually either binary or continuous . Binary data involve a yes/no categorization ( for example , death or survival ) . Continuous data take a range of values ( for example , change in diastolic blood pressure after antihypertensive treatment , measured in mm Hg ) . When one is comparing groups of patients , binary data can be summarized by using several measures of treatment effect that were discussed earlier in this series [ 3 ] . These measures include the risk ratio ; the odds ratio ; the risk difference ; and , when study duration is important , the incidence rate . Another useful clinical measure , the number needed to treat ( NNT ) , is derived from the inverse of the risk difference [ 3 ] . Treatment effect measures , such as the risk ratio and the odds ratio , provide an estimate of the relative efficacy of an intervention , whereas the risk difference describes the intervention 's absolute benefit . The various measures of treatment effect offer complementary information , and all should be examined [ 4 ] . Continuous data can be summarized by the raw mean difference between the treatment and control groups when the treatment effect is measured on the same scale ( for example , diastolic blood pressure in mm Hg ) , by the st and ardized mean difference when different scales are used to measure the same treatment effect ( for example , different pain scales being combined ) , or by the correlation coefficients between two continuous variables [ 5 ] . The st and ardized mean difference , also called the effect size , is obtained by dividing the difference between the mean in the treatment group and the mean in the control group by the SD in the control group . Evaluating the Statistical Heterogeneity of the Data This step is intended to answer the question , Are the results of the different studies similar ( homogeneous ) ? It is important to answer this question before combining any data . To do this , one must calculate the magnitude of the statistical diversity ( heterogeneity ) of the treatment effect that exists among the different sets of data . Statistical diversity can be thought of as attributable to one or both of two causes . First , study results can differ because of r and om sampling error . Even if the true effect is the same in each study , the results of different studies would be expected to vary r and omly around the true common fixed effect . This diversity is called the within- study variance . Second , each study may have been drawn from a different population , depending on the particular patients chosen and the interventions and conditions unique to the study . Therefore , even if each study enrolled a large patient sample , the treatment effect would be expected to differ . These differences , called r and om effects , describe the between- study variation with regard to an overall mean of the effects of all of the studies that could be undertaken . The test most commonly used to assess the statistical significance of between- study heterogeneity is based on the chi-square distribution [ 6 ] . It provides a measure of the sum of the squared differences between the results observed and the results expected in each study , under the assumption that each study estimates the same common treatment effect . A large total deviation indicates that a single common treatment effect is unlikely . Any pooled estimate calculated must account for the between- study heterogeneity . In practice , this test has low sensitivity for detecting heterogeneity , and it has been suggested that a liberal significance level , such as 0.1 , should be used [ 6 ] . Estimating a Common Effect The questions that this step tries to answers are , 1 ) To the extent that data are similar , what is their best common point estimate of a therapeutic effect , and 2 ) how precise is this estimate ? The mathematical process involved in this step generally involves combining ( pooling ) the results of different studies into an overall estimate . Compared with the results of individual studies , pooled results can increase statistical power and lead to more precise estimates of treatment effect . Each study is given a weight according to the precision of its results . The rationale is that studies with narrow CIs should be weighted more heavily than studies with greater uncertainty . The precision is generally expressed by the inverse of the variance of the estimate of each study . The variance has two components : the variance of the individual study and the variance between different studies . When the between- study variance is found to be or assumed to be zero , each study is simply weighted by the inverse of its own variance , which is a function of the study size and the number of events in the study . This approach characterizes a fixed-effects model , as exemplified by the Mantel-Haenszel method [ 7 , 8 ] or the Peto method [ 9 ] for dichotomous data . The Peto method has been particularly popular in the past . It has the advantage of simple calculation ; however , although it is appropriate in most cases , it may introduce large biases if the data are unbalanced [ 10 , 11 ] . On the other h and , r and om-effects models also add the between- study variance to the within- study variance of each individual study when the pooled mean of the r and om effects is calculated . The r and om-effects model most commonly used for dichotomous data is the DerSimonian and Laird estimate of the between- study variance [ 12 ] . Fixed- and r and om-effects models for continuous data have also been described [ 13 ] . Pooled results are generally reported as a point estimate and CI , typically a 95 % CI . Other quantitative techniques for combining data , such as the Confidence Profile Method [ 14 ] , use Bayesian methods to calculate posterior probability distributions for effects of interest . Bayesian statistics are based on the principle that each observation or set of observations should be viewed in conjunction with a prior probability describing the prior knowledge about the phenomenon of interest [ 15 ] . The new observations alter this prior probability to generate a posterior probability . Traditional meta- analysis assumes that nothing is known about the magnitude of the treatment effect before r and omized trials are performed . In Bayesian terms , the prior probability distribution is noninformative . Bayesian approaches may also allow the incorporation of indirect evidence in generating prior distributions [ 14 ] and may be particularly helpful in situations in which few data from r and omized studies exist [ 16 ] . Bayesian analyses may also be used to account for the uncertainty introduced by estimating the between- study variance in the r and om-effects model , leading to more appropriate estimates and predictions of treatment efficacy [ 17 ] . Exploring and Explaining Heterogeneity The next important issue is whether the common estimate obtained in the previous step is robust . Sensitivity analyses determine whether the common estimate is influenced by changes in the assumptions and in the protocol for combining the data . A comparison of the results of fixed- and r and om-effects models is one such sensitivity analysis [ 18 ] . Generally , the r and om-effects model produces wider CIs than does the fixed-effects model , and the level of statistical significance may therefore be different depending on the model used . The pooled point estimate per se is less likely to be affected , although exceptions are possible [ 19 ] . Other sensitivity analyses may include the examination of the residuals and the chi-square components [ 13 ] and assessment of the effect of deleting each study in turn . Statistically significant results that depend on a single study may require further exploration . Cumulative Meta- Analysis",
"& NA ; This study compares the responsiveness of three instruments of functional status : two disease‐specific question naires ( Oswestry and Rol and Disability Question naires ) , and a patient‐specific method ( severity of the main complaint ) . We compared changes over time of functional status instruments with pain rated on a visual analog scale . Two strategies for evaluating the responsiveness in terms of sensitivity to change and specificity to change were used : effect size statistics and receiver‐operating characteristic method . We chose global perceived effect as external criterion . A cohort of 81 patients with non‐specific low back pain for at least 6 weeks assessed these measures before and after 5 weeks of treatment . According to the external criterion 38 patients improved . The results of both strategies were the same . All instruments were able to discriminate between improvement and non‐improvement . The effect size statistics of the instruments were higher in the improved group than in the non‐improved group . For each instrument the receiver‐operating characteristic curves showed some discriminative ability . The curves for the Rol and Question naire and pain were closer to the upper left than the curves for the other instruments . The sensitivity to change of the rating of Oswestry Question naire was lower than that of the other instruments . The main complaint was not very specific to change . The two strategies for evaluating the responsiveness were very useful and appeared to complement each other",
"Objectives Knowledge regarding the working mechanism of an intervention is essential for obtaining a better underst and ing of the intervention and contributes to optimize its outcome . This study aim ed at investigating whether changes in cognitive-behavioral factors and muscle activation patterns after myofeedback training and ergonomic counseling were associated with outcome , in subjects with work-related musculoskeletal neck-shoulder complaints . Methods Seventy-nine symptomatic subjects received either myofeedback with ergonomic counseling ( Mfb/EC ) or ergonomic counseling alone ( EC ) . Outcome measures discomfort and disability , and process factors catastrophizing , pain control , fear-avoidance beliefs , and muscle activation patterns were assessed at baseline , after the interventions ( T0 ) , and at 3 months follow-up ( T3 ) . Mixed modeling techniques were used for analysis . Results Outcome in terms of discomfort and disability was generally comparable between both interventions . Catastrophizing was significantly reduced and fear-avoidance beliefs about work slightly increased after the interventions , but no consistent changes in muscle activation patterns were observed . Changes in discomfort were especially associated with changes in catastrophizing at T0 and T3 , but R2 was low ( catastrophizing at T0 and T3 , and also reduced fear-avoidance beliefs about work at T3 , were related to reduced disability ( R2 between 0.30 and 0.40 ) . No differences between the two intervention groups were observed . Conclusions Intervention effects were generally non-specific and findings suggested that cognitive-behavioral factors underlie the outcome of these interventions rather than changes in muscle activation patterns . Emphasizing these factors during therapy may increase the beneficial outcome of occupational interventions",
"To determine the effectiveness of high voltage pulsed current ( HVPC ) in reducing chronic h and edema , 120 individuals were r and omly assigned to one of two treatment groups . Group I clients were given an appropriate sized wrist splint , incorporating an energized , high voltage pulsed unit Group II clients were given an identical splint with a non-energized unit . Each client received daily treatments at the worksite consisting of 30 minute sessions totaling 20 treatments during a 35 day period . Pre-treatment and post-treatment evaluations included measurements of pain , grip strength , and edema volume ; repetitive task testing ; and Semmes-Weinstein Monofilament sensory testing . In the energized group , post-treatment evaluation showed statistically significant decreases in the amount of stimulation required to stimulate the median nerve and the amount of h and edema and pain . The energized group also had improved repetitive task times . None of these improvements occurred in the non-energized group . Based on these results , HVPC appears to be an effective method for minimizing the severity of repetitive stress injuries of the wrist",
"OBJECTIVES The aim of this study was to assess the effect of an ergonomic intervention on pain and sickness absence caused by upper-extremity musculoskeletal disorders . METHODS In this r and omized controlled study , subjects aged 18 - 60 years ( N=177 ) seeking medical advice due to upper-extremity symptoms were included if their symptoms , or the exacerbation of symptoms , had started Workplace ergonomic improvements were made in the intervention group . Data on symptoms and sickness absences were gathered during one-year follow-up . RESULTS Pain intensity , pain interference with work , leisure time , or sleep did not differ between the intervention and control group during the one-year follow-up . During the first three months of follow-up , the percentage of employees with sickness absence due to upper-extremity or other musculoskeletal disorders did not differ between the intervention ( N=89 ) and control ( N=84 ) group , but the total number of sickness absence days in the intervention group was about half of that in the control group ( mean 6.2 versus 9.8 days for upper-extremity disorder and 6.0 versus 11.5 days for upper-extremity and other musculoskeletal disorders combined ) . During 4 - 12 months of follow-up , the percentage of employees with sickness absence due to upper-extremity disorder ( 10.1 % versus 16.7 % , P=0.20 ) or upper-extremity and other musculoskeletal disorders combined ( 20.2 % versus 32.1 % , P=0.07 ) was lower in the intervention than the control group . CONCLUSIONS Our findings suggest that an early ergonomic intervention reduces sickness absence due to upper-extremity or other musculoskeletal disorders",
"Context Nonoccupational musculoskeletal disorders account for a large proportion of work disability and represent a major financial burden on society . Contribution A voluntary , r and omized , controlled intervention study consisted of avoidance of bed rest , early mobilization , avoidance of splints , stretching exercises , ergonomic training , provision of educational booklets , and suggestions for optimal levels of physical activity . Although return to work was never forced , temporary work disability , long-term disability , and costs were significantly decreased in the intervention group . Implication s The personal and financial impact of work disability due to musculoskeletal disorders ( not related to work injury ) may be mitigated by a voluntary program of education and rehabilitation . The Editors Musculoskeletal disorders ( MSDs ) are prevalent and potentially disabling conditions ( 1 ) that consume a large proportion of health care re sources ( 2 - 4 ) and together are the leading cause of functional loss in adults ( 3 - 8 ) . The social costs of MSDs are enormous , often overshadowing those of other chronic conditions ( 9 , 10 ) . In industrialized societies , MSDs are one of the most common causes of temporary work disability and the chief cause of permanent work disability ( 11 ) , accounting for productivity losses equivalent to 1.3 % of the U.S. gross national product ( 12 ) . Work disability related to MSDs is a challenge to employability , business productivity , and the capacity of health and social security systems . Various strategies for addressing MSD-related work disability have been promoted in the field of occupational health , including strategies involving legislation , risk management , ergonomics , prevention , education , and social work ( 13 ) . However , the role of health systems remains ill-defined in this field . The purpose of this study was to evaluate whether an intervention program , integrated into the health system and offered to the working population , could reduce the impact of recent-onset MSD-related temporary work disability . Methods Setting Of the 5.5 million persons in Madrid , Spain , 98 % receive health coverage from the Instituto Madrileo de Salud . Care is organized into 11 health districts . Patients have direct access to primary care physicians , who refer patients to specialized care if needed . Disability compensation payments are made by the Instituto Nacional de la Seguridad Social ( INSS ) , a division of the Ministry of Work . Any worker who requires sick leave is given a temporary work disability initiation form that states the diagnosis made by the primary care physician and entitles the worker to receive INSS compensation payments . The form is renewed weekly by the primary care physician until the worker 1 ) recovers and receives an ending form , 2 ) reaches a maximum of 18 months of temporary work disability , or 3 ) receives a proposal for evaluation for permanent work disability . Proposals for permanent work disability are evaluated by the INSS , which determines the need for and type of long-term compensation . Inspection services in each health district oversee all administrative aspects of these processes . Design We did a r and omized , controlled study , unblinded for both patients and physicians , to test whether a clinical intervention could improve the outcome of patients with recent-onset MSD-related temporary work disability . The study began in March 1998 in health district 7 and in March 1999 in health districts 4 and 9 . Selection and r and omization of patients was done during the first year of the study in each district . Follow-up lasted for another year . Patients and Selection Criteria Health districts 4 , 7 , and 9 were chosen . Health district 4 had a total population of 508249 persons and an active working population of 192939 persons ; health district 7 had a total population of 522742 persons and an active working population of 179155 persons ; and health district 9 had a total population of 371294 persons and an active working population of 135475 persons ( 14 ) . The inclusion criterion was the issue of a common diseases temporary work disability initiation form , with an MSD-related cause reported by the primary care physician , within the inclusion period . The MSD-related causes included all arthropathies , connective tissue disorders , back disorders , soft-tissue rheumatisms , bone and cartilage disorders , musculoskeletal pain not caused by cancer , and nerve entrapment syndromes . Patients were excluded if they had a common diseases temporary work disability form with an MSD-related cause result ing from trauma or surgery . They were also excluded if they had work accidents or professional diseases noted on the temporary work disability initiation form . Work accidents are primarily sudden , external , violent causes of disease occurring at work or during travel to work , and they represent less than 27 % of cases of temporary work disability . Professional diseases include silicosis , asbestos-related mesothelioma , and noise-induced hearing loss , and they represent less than 1 % of cases of temporary work disability . R and omization All temporary work disability initiation forms meeting the selection criteria were collected daily by a study rheumatologist and coded . The patients associated with the forms were r and omly assigned to either the intervention group , which received a specific care program , or the control group , which received st and ard care ( Figure 1 ) . Computer-generated lists of pseudor and om numbers were produced for each district . Group assignments were r and omly done in blocks of 50 patients with intervention : control ratios of 1:1 in district 7 and 2:3 in districts 4 and 9 . This was done so that similar numbers of patients would be seen by the rheumatologists in all areas . The ratios were based on the number of episodes of MSD-related temporary work disability registered in previous years . Patients maintained their group assignments in successive episodes of MSD-related temporary work disability during follow-up . Figure 1 . Flow diagram of the study . Care in the Intervention Group A secretary contacted all patients assigned to the intervention group by telephone or mail as soon as possible after the initiation form was issued , offering them an appointment in the program . Patients who voluntarily decided to enter the program were attended by 2 rheumatologists in each district who worked full-time for the study . Patients were seen as often as necessary until the episode of temporary work disability was resolved or recovery was deemed unrealistic . Patients who were assigned to the intervention group but were unable or unwilling to participate , were already working , or could not be located were considered to be assigned to the intervention group throughout the study for statistical purpose s. Within the intervention program , care was delivered in regular visits and included education , clinical management , and administrative duties . Education At the first 45-minute visit , patients received a specific diagnosis , reassurance that no serious disease was present , instructions on self-management , instructions on taking medications on a fixed schedule , and information on indications for return to work before complete symptom remission . Return to work was negotiated with patients and was never forced on them . Instructions on self-management included instructions to avoid bed rest , instructions to promote early mobilization of the painful regions , restrictions on the use of splint and neck collars , training in stretching and strengthening exercises ( 15 - 18 ) , teaching of ergonomic care ( 19 ) , delivery of booklets in instances of back or neck pain ( 19 ) , and information on optimal levels of physical activity ( 20 ) . Patients with higher degrees of disability or abnormal pain behavior received immediate extra reassurance , information on pain-relieving positions , and a telephone call or second visit within 72 hours . Specific protocol s were created for low-back ( 21 ) , neck , shoulder , arm and h and , knee , and foot pain ( 19 , 22 - 25 ) and included the 3-level clinical -management system described later . Moving a patient from the lower to the upper levels of the system implied the need for further diagnostic or therapeutic procedures and was indicated 1 ) after a patient spent a predefined period at the lower level without return to work or substantial clinical improvement or 2 ) by the clinical judgment of the rheumatologist . At the first level of the system , patients received the clinical management started at the first visit , including a diagnosis based on clinical criteria , pharmacologic treatment of pain and inflammation , pharmacologic treatment of anxiety and depression , peripheral intra- and periarticular injections ( 26 ) , and education . Time spent at the first level averaged 2 to 6 weeks . At the second level , patients received maintenance of therapy plus referral for formal rehabilitation and laboratory tests , radiography , computerized tomography , magnetic resonance imaging , and electromyography . After 4 to 8 weeks with no improvement at the second level , patients were moved to the third level and received further diagnostic procedures or referral for surgical or other specialized care . Red flags were defined , including age older than 50 years for patients with axial pain , previous trauma , cancer , serious medical illness , inflammatory pain , night pain , drug abuse , corticosteroid use , fever , weight loss , progressively deteriorating function , and progressive neurologic deficit . The presence of a red flag precluded the use of the level system , and the patient in question was managed according to clinical criteria , with a focus on excluding serious illness . Treatment Failures Patients who did not respond to interventions at the second level of the system were examined for the presence of yellow flags , which included psychiatric illness , family problems , sociolabor conflicts , unemployment , and occupational causes of disability . The presence of a",
"CONTEXT Active physical training is commonly recommended for patients with chronic neck pain ; however , its efficacy has not been demonstrated in r and omized studies . OBJECTIVE To evaluate the efficacy of intensive isometric neck strength training and lighter endurance training of neck muscles on pain and disability in women with chronic , nonspecific neck pain . DESIGN Examiner-blinded r and omized controlled trial conducted between February 2000 and March 2002 . SETTING Participants were recruited from occupational health care systems in southern and eastern Finl and . PATIENTS A total of 180 female office workers between the ages of 25 and 53 years with chronic , nonspecific neck pain . INTERVENTIONS Patients were r and omly assigned to either 2 training groups or to a control group , with 60 patients in each group . The endurance training group performed dynamic neck exercises , which included lifting the head up from the supine and prone positions . The strength training group performed high-intensity isometric neck strengthening and stabilization exercises with an elastic b and . Both training groups performed dynamic exercises for the shoulders and upper extremities with dumbbells . All groups were advised to do aerobic and stretching exercises regularly 3 times a week . MAIN OUTCOME MEASURES Neck pain and disability were assessed by a visual analog scale , the neck and shoulder pain and disability index , and the Vernon neck disability index . Intermediate outcome measures included mood assessed by a short depression inventory and by maximal isometric neck strength and range of motion measures . RESULTS At the 12-month follow-up visit , both neck pain and disability had decreased in both training groups compared with the control group ( P Maximal isometric neck strength had improved flexion by 110 % , rotation by 76 % , and extension by 69 % in the strength training group . The respective improvements in the endurance training group were 28 % , 29 % , and 16 % and in the control group were 10 % , 10 % , and 7 % . Range of motion had also improved statistically significantly in both training groups compared with the control group in rotation , but only the strength training group had statistically significant improvements in lateral flexion and in flexion and extension . CONCLUSIONS Both strength and endurance training for 12 months were effective methods for decreasing pain and disability in women with chronic , nonspecific neck pain . Stretching and fitness training are commonly advised for patients with chronic neck pain , but stretching and aerobic exercising alone proved to be a much less effective form of training than strength training",
"OBJECTIVE Previously we reported that early part-time sick leave enhances return to work ( RTW ) among employees with musculoskeletal disorders ( MSD ) . This paper assesses the health-related effects of this intervention . METHODS Patients aged 18 - 60 years who were unable to perform their regular work due to MSD were r and omized to part- or full-time sick leave groups . In the former , workload was reduced by halving working time . Using vali date d question naires , we assessed pain intensity and interference with work and sleep , region-specific disability due to MSD , self-rated general health , health-related quality of life ( measured via EuroQol ) , productivity loss , depression , and sleep disturbance at baseline , 1 , 3 , 8 , 12 , and 52 weeks . We analyzed the repeated measures data ( 171 - 356 observations ) with the generalized estimating equation approach . RESULTS The intervention ( part-time sick leave ) and control ( full-time sick leave ) groups did not differ with regard to pain intensity , pain interference with work and sleep , region-specific disability , productivity loss , depression , or sleep disturbance . The intervention group reported better self-rated general health ( adjusted P=0.07 ) and health-related quality of life ( adjusted P=0.02 ) than the control group . In subgroup analyses , the intervention was more effective among the patients whose current problem began occurring productivity loss at baseline . CONCLUSIONS Our findings showed that part-time sick leave did not exacerbate pain-related symptoms and functional disability , but improved self-rated general health and health-related quality of life in the early stage of work disability due to MSD",
"OBJECTIVE The objective of this study was to evaluate the effects of regular stretching exercises on pain associated with working at a computer workstation , and to ascertain whether the type of media used for exercise instruction had an effect on outcomes . PARTICIPANTS Sixty-eight volunteers were divided into three equivalent groups . All of the subjects worked at computers for prolonged periods of time and reported that their pain had been a source of distress for at least three weeks prior to the intake evaluation . METHODS A pretest-posttest-control group design with cluster r and omization was used to evaluate the effect of a stretching program on pain . Thirty-six different stretches were performed by the subjects for 15 - 17 work days . Two intervention groups were directed to stretch once every six minutes . One group ( n=22 ) was reminded to stretch via a computer program , the second group ( n=23 ) by using a hard copy version of the stretches with pictures and written instructions , and a third group received no intervention . RESULTS ANOVA analysis found a significant reduction in pain of 72 % ( p computer-generated stretching program , and of 64 % ( p pain of 1 % . CONCLUSIONS Both software and hard copy stretching interventions contributed to a decrease in pain without making any changes to workstation ergonomics and there was no significant statistical difference in the outcomes of either intervention . The subjective evaluation of pain using both visual analog scales and a newly created \" pain spot \" assessment technique yielded similar results",
"The study was initiated to evaluate the effect of pain-reducing therapies on factors previously associated with work-related shoulder and neck pain , namely increased muscle activity in the upper trapezius and perceived general tension . Thirty-three women in three groups were assessed before and after an intervention period and by question naire 6 months later . The purpose of this study was primarily to investigate associations between upper trapezius muscle activity , perceived general tension and pain , and secondly , to compare effects of individually based physiotherapy and group exercise for workers with shoulder and neck myalgia . All three groups reported a significant alleviation of pain and perceived general tension , while the electromyographically ( EMG ) recorded upper trapezius muscle activity level remained unchanged or increased . Improvements were similar in all three treatment groups , but individual-based therapies were rated more beneficial on subjective measures . Significant correlation was found between pain and perceived general tension ( r = 0.66 , p < 0.01 ) , while there was no correlation between pain or perceived general tension and recorded muscle activity",
"& NA ; The purpose of the study was to examine the effects of a workplace physical exercise intervention on the perceived intensity of headache and the intensity of symptoms in the neck and shoulders , as well as on the extension and flexion strength of the upper extremities . The study was a cluster r and omized controlled trial . The cross‐over design consisted of physical exercise intervention ( 15 weeks ) and no‐intervention ( 15 weeks ) . The subjects ( n=53 ) were office workers ( mean age 46.6 ( SD 8.4 ) ) who reported headache ( n=41 ) symptoms in the neck ( n=37 ) or shoulders ( n=41 ) , which had restricted their daily activities during the last 12 months . Pain symptoms were measured using the Borg CR10 scale and muscular strength with a 5RM test . Statistical analyses were based on linear mixed models . Physical exercise intervention result ed in a slight , but statistically significant , decrease in the intensity of headache and neck symptoms , as well as an increase in the extension strength of the upper extremities . The mean decrease in headache during the 5‐week period was 0.64 CR10 ( 95 % CI 0.28–1.00 ) ( P=0.001 ) or 49 % ( 95 % CI 22–77 ) , and 0.42 CR10 ( 95 % CI 0.11–0.72 ) ( P=0.002 ) or 49 % ( 95 % CI 13–85 ) in the intensity of neck symptoms . The mean increase in the extension strength of the upper extremities was 1.3 kg ( 95 % CI 0.5–2.1 ) ( P=0.001 ) or 4 % ( 95 % CI 1–6 ) . The intervention had no effect on the intensity of shoulder symptoms or the flexion strength of the upper extremities . Specific exercise may be clinical ly important to alleviate headache and neck symptoms ",
"BACKGROUND The aim of the present study is to explore factors affecting or modifying self-reported neck/shoulder pain in sewing machine operators . METHODS We investigated self-report neck/shoulder pain in 247 workers who participated in a 4-month prospect i ve intervention study for musculoskeletal disorders . All participants were immigrants . We examine the influence of individual and work-related factors on changes in neck/shoulder pain during follow-up employing linear mixed models with time-spline functions . RESULTS We observed a dramatic decline ( 72 % ) in self-reported pain intensity in the first month of follow-up , followed by a small increase from the first to fourth month ( 4 % per month ) . Workers who perceived and reported their physical workload as high or worked overtime experienced less overall pain reduction . Higher baseline pain intensity , being of Hispanic ethnicity ( vs. Asian ) , and taking cumulative daily rest time during work of 35 min or more allowing for muscles to rest were associated with a larger pain reduction in the first month , but not thereafter . CONCLUSION Our findings indicate that some work-related factors may be of clinical relevance for reducing neck/shoulder pain . Having lower physical workloads and less overtime work should be considered when treating patients or planning workplace interventions for managing work-related musculoskeletal disorders in this underserved immigrant population",
" Nineteen Ss who experienced chronic , occupational pain of the upper limbs and who had previously completed a programme of either individual or group cognitive-behaviour therapy were followed up 2 yr later . Significant improvements on measures of depression , anxiety , coping strategies and interference in daily living were found following treatment . Such improvements were not evident for the waiting list control Ss and no difference was found between group vs individual applications of therapy . A 2 yr follow-up , significant improvements from pre-treatment levels were evident for depression , coping strategies , significant other report of disability , self monitored pain and distress caused by pain . While there was generally little evidence of relapse , a significant decline from post-treatment levels was found for the individual therapy condition compared to the group therapy condition on measures of self monitored pain and interference caused by pain . Since post-treatment levels tended to be somewhat superior for the individual therapy condition , the overall finding at 2 yr follow-up was of minimal difference in outcome for group vs individual forms of cognitive-behaviour therapy . Despite improvements from pre-treatment levels , the vast majority of Ss still reported significant and distressing levels of pain at 2 yr follow-up",
"There is evidence that performing job tasks involving repetition , vibration , sustained posture or forceful movement may contribute to symptoms of work related upper extremity disorders . Typing is one such activity ; symptoms that develop as a result of this activity can affect performance of work , self-care and leisure occupations . Studies investigating the impact of ergonomic keyboards on symptom reduction are limited , and little research exists regarding the reduction of key activation force as an intervention . Methods : This r and omized , prospect i ve study used a sample of 68 symptomatic workers employed by a single company . One group received a commercially available ergonomic keyboard , a second group used a modified version of the same keyboard design ed to reduce activation force , vibration and key travel . We measured symptoms and clinical signs , functional status , and device satisfaction in both groups over a six-month study period . Results : Between-groups analyses indicated that the groups performed similarly on the outcomes of interest . Repeated-measure analysis identified a reduction of symptoms , an improvement in functional status , preference for and increased satisfaction with the intervention keyboards , and maintenance of typing speed and accuracy for both groups . Conclusions",
"The effects of group gymnastics on neck pain were studied among 44 women in a printing company . A r and omized cross-over design was used with two groups matched according to the work task , frequency of symptoms , and age . The treatment consisted of gymnastics for 45 min once a week for 10 weeks . Neck pain was rated by visual analogue scale and pressure pain sensitivity of the neck muscles was measured with an algometer . The results showed no clear effects of the group gymnastics program . An equal and significant reduction in pain ratings was seen in both groups after the first intervention in the spring . Recurrence of symptoms was seen in both groups in September , and no significant reduction in pain occurred during the second intervention in the autumn . The results suggest a seasonal variation in neck symptoms which has to be considered when planning or evaluating intervention studies",
" The cluster r and omized trial with a concurrent economic evaluation is considered the gold st and ard evaluative design for the conduct of implementation research evaluating different strategies to promote the transfer of research findings into clinical practice . This has implication s for the planning of such studies , as information is needed on the effects of clustering on both effectiveness and efficiency outcomes . This paper describes the design considerations specific to implementation research studies , focusing particularly on the estimation of sample size requirements and on the need for reliable information on intracluster correlation coefficients for both effectiveness and efficiency outcomes",
"OBJECTIVES To determine whether nocturnal splinting of workers identified through active surveillance with symptoms consistent with carpal tunnel syndrome ( CTS ) would improve symptoms and median nerve function as well as impact medical care . DESIGN R and omized controlled trial . SETTING A Midwestern auto assembly plant . PARTICIPANTS Active workers with symptoms suggestive of CTS based on a h and diagram . INTERVENTION The treatment group received customized wrist splints , which were worn at night for 6 weeks ; the control group received ergonomic education alone . MAIN OUTCOME MEASURES Change in wrist , h and , and /or finger discomfort , carpal tunnel symptom severity index , median sensory nerve function , and the percentage of subjects who had carpal tunnel release surgery . RESULTS The splinted group , unlike the controls , had a significant reduction in wrist , h and , and /or finger discomfort and a similar trend in the Levine carpal tunnel symptom severity index , which was maintained at 12 months . A secondary analysis showed that more median nerve impairment at baseline was associated with less clinical improvement among controls but not among the splinted group . CONCLUSIONS Workers identified with CTS symptoms in an active symptom surveillance tended to benefit from a 6-week nocturnal splinting trial , and the benefits were still evident at the 1-year follow-up . The splinted group improved in terms of h and discomfort regardless of the degree of median nerve impairment , whereas the controls showed improvement only among subjects with normal median nerve function . Results suggest that a short course of nocturnal splinting may reduce wrist , h and , and /or finger discomfort among active workers with symptoms consistent with CTS",
"OBJECTIVES This study evaluated the effect of an intensive ergonomic approach and education on workstation changes and musculoskeletal disorders among workers who used a video display unit ( VDU ) . METHODS A r and omized controlled design was used . The subjects ( N=124 ) were allocated into three groups ( intensive ergonomics , ergonomic education , reference ) using stratified r and om sampling . The evaluation involved question naires , a diary of discomfort , measurements of workload , and an ergonomic rating of the workstations . The assessment s were made 2 weeks before the intervention and after 2 and 10 months of follow-up . RESULTS The intensive and training groups showed less musculoskeletal discomfort than the reference group after 2 months of follow-up . Positive effects on discomfort were seen primarily for the shoulder , neck , and upper back areas . No significant differences were found for the strain levels or prevalence of pain . After the intervention the ergonomic level was distinctly higher in the intensive ergonomic group than in the education or reference group . CONCLUSIONS Both the intensive ergonomics approach and education in ergonomics help reduce discomfort in VDU work . In attempts to improve the physical ergonomics of VDU workstations , the best result will be achieved with cooperative planning in which both workers and practitioners are actively involved",
"PURPOSE The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance , muscle strength gains , and neck/shoulder pain in office workers . METHODS A 1-yr r and omized controlled intervention trial was done with three groups : specific resistance training ( SRT , n = 180 ) , all-round physical exercise ( APE , n = 187 ) , and reference intervention ( REF , n = 182 ) with general health counseling . Physical tests were performed and question naires answered at pre- , mid- , and postintervention . The main outcome measures were compliance , changes in maximal muscle strength , and changes in intensity of neck/shoulder pain ( scale 0 - 9 ) in those with and without pain at baseline . RESULTS Regular participation was achieved by 54 % , 31 % , and 16 % of those of the participants who answered the question naire in SRT ( 78 % ) , APE ( 81 % ) , and REF ( 80 % ) , respectively , during the first half of the intervention period , and decreased to 35 % , 28 % and 9 % , respectively , during the second half . Shoulder elevation strength increased 9 - 11 % in SRT and APE ( P Participants with neck pain at baseline decreased the intensity of neck pain through SRT , from 5.0 + /- 0.2 to 3.4 + /- 0.2 ( P pain over the 1-yr period in REF compared with SRT and APE ( P shoulder elevation strength , were more effective than REF to decrease neck pain among those with symptoms at baseline , and prevent development of shoulder pain in those without symptoms at baseline",
"Study Design . This is a 4-month r and omized controlled trial to evaluate the effect of chair design on neck/shoulder pain among sewing machine operators . Objective . Determine whether a chair with a curved seat pan leads to improved changes in monthly neck/shoulder pain scores compared with a control intervention . Summary of Background Data . Sewing machine operators experience a high prevalence and severity of neck and shoulder pain in comparison to other working population s probably due to the sustained shoulder abduction and neck and upper back flexion required of the task . An adjustable height task chair that supports a forward sitting posture may reduce these posture-related risk factors and reduce neck/shoulder pain . Material s and Methods . A total of 277 sewing machine operators with neck/shoulder pain were assigned to receive 1 ) miscellaneous items ( control group ) , 2 ) a chair with a flat seat pan plus miscellaneous items , or 3 ) a chair with a curved seat pan plus miscellaneous items . Participants completed a monthly question naire assessing neck/shoulder pain severity . Results . Based on estimates of pain score changes from a repeat- measures linear regression , participants who received the flat seat chair experienced a decline in pain of 0.14 ( 95 % confidence interval , 0.07–0.22 ) points per month compared with those in the control group , while those who received the curved seat experienced a decline of 0.34 ( 95 % confidence interval , 0.28–0.41 ) points per month compared with those in the control group . These estimates did not change after adjustment for potential covariates . Conclusions . These findings demonstrate that an adjustable height task chair with a curved seat pan can reduce neck and shoulder pain severity among sewing machine operators",
"OBJECTIVE To investigate the clinical course and prognostic factors of complaints of arm , neck , and shoulder . STUDY DESIGN AND SETTING A prospect i ve cohort study in physical therapy practice . Participating physiotherapists recruited new consulters with musculoskeletal complaints of the neck and /or upper extremities . Participants filled in question naires at baseline , 3 months , and 6 months . The main outcome measure was the persistence of complaints over 6-month follow-up . Possible predictors like social and psychological factors , physical factors , and complaint specific factors were tested in univariate and multivariate logistic regression analyses for repeated measurements . RESULTS Of the 624 participants at baseline 543 ( 87 % ) returned at least one follow-up question naire . At 6-month follow-up , 40 % had persisting pain and discomfort . Somatization , kinesiophobia , catastrophizing , and a long duration of complaints at baseline were significantly related to the persistence of complaints over 6 months in the total population . In those with paid work ( 77 % ) , catastrophizing , low decision authority at work , and a long duration of complaints at baseline were significantly related to the persistence of complaints over 6 months . CONCLUSION 40 % of the participants had persisting pain and discomfort after 6 months and mainly social and psychological factors played a role in this course",
"Abstract The effect of exercise on neck – shoulder pain was studied in 103 women with work‐related trapezius myalgia r and omized into three exercise groups and a control group . One group trained strength , the second muscular endurance and the third co‐ordination . The exercise groups met three times weekly for 10 weeks . Pain assessment was made on three visual analogue scales , indicating pain at present , pain in general and pain at worst . Pain thresholds were measured in the trapezius muscle with a pressure algometer . A pain drawing was completed . The rated pain decreased significantly ( P groups . Pressure sensitivity decreased significantly ( P the extent of painful body area in any group . Comparison of exercisers ( n=82 ) and controls ( n=21 ) showed significantly larger pain reductions on VAS pain at present and VAS pain at worst among exercisers . All three exercise programs showed similar decreases of pain which indicates that the type of exercise is of less importance to achieve pain reduction",
"OBJECTIVES To study whether isometric shoulder endurance was more advantageous than isometric shoulder strength training in reducing pain and perceived exertion and to increase shoulder function through improved muscle endurance and strength . DESIGN R and omized trial . SETTING Three occupational health care centers . PARTICIPANTS Women industrial workers with nonspecific neck-shoulder pain . The International Classification of Diseases , 10th Revision ( ICD-10 ) diagnosis was \" cervicobrachial syndrome \" ( M53.1 ) . Thirty-eight patients completed the isometric shoulder endurance training and 31 patients completed the isometric shoulder strength training . INTERVENTION Twelve weeks of training . MAIN OUTCOME MEASURES Self-reported pain and rating of perceived exertion ( RPE ) , arm motion performance test , shoulder muscle strength , shoulder muscle endurance , and shoulder functional tests , as well as follow-up after supervised training had ended . RESULTS The isometric shoulder strength training result ed in an almost one-scale step decrease in RPE at work and a 5 % to 15 % improvement of arm motion performance compared with the endurance training . The isometric shoulder strength training more effectively improved left side shoulder abduction strength ( p isometric shoulder endurance training was not more successful than the strength training in the endurance test ( p .51 to .81 ) . CONCLUSIONS Physical training programs for neck-shoulder pain may include isometric shoulder muscular strength exercise in addition to isometric shoulder endurance training , rather than endurance training only",
"Forty five subjects who experienced chronic , occupational pain of the upper limbs were r and omly assigned to one of three conditions ; individual cognitive-behaviour therapy ( ICBT ) , group cognitive-behaviour therapy ( GCBT ) and WLC . Significant benefits were found for both ICBT and GCBT on measures of anxiety , depression , coping strategies , impact on daily living , pain and distress caused by pain . These gains were not evident in the WLC and were maintained at the 6 month follow-up Minimal difference was found between ICBT and GCBT on measures of pain and psychopathology , although client evaluation ratings at the end of treatment favoured ICBT",
"OBJECTIVES This study examined the health-related effects of two worksite interventions , physical exercise and reduced workhours , on women employed in dentistry . METHODS Six workplaces were r and omized to one of the following three conditions : ( i ) 2.5 hours of weekly , m and atory physical exercise of middle-to-high intensity to be performed during workhours ( N=62 ) , ( ii ) a reduction of full-time weekly workhours from 40 to 37.5 hours ( N=50 ) , and ( iii ) reference . In all , 177 women participated . Biomarkers and self-ratings in question naires were obtained before the intervention ( T ( 1 ) ) , and six ( T ( 2 ) ) and 12 months ( T ( 3 ) ) after the intervention . RESULTS The results showed increased levels of physical activity and exercise in all of the groups , the level of physical exercise being significantly greater in the physical exercise group . Repeated- measures analyses of variance using data from T ( 1 ) and T (3)for biological measures and all three time points for self-ratings produced significant interaction effects for glucose , waist-to-hip ratio , and work ability and clear trends for general symptoms and upper-extremity disorders . Posthoc analyses showed that the results of the health-related measures differed between the interventions , decreased glucose and upper-extremity disorders in the exercise group , and increased high-density lipoprotein and waist-to-hip ratio among those working reduced hours . CONCLUSIONS These results show that the two interventions had small and varied effects on biomarkers and self-reports of different aspects of health among women . It is suggested that interventions involving a modest reduction in workhours seem to be more effective if these hours are used for physical exercise",
"OBJECTIVES This study evaluates the effect of two different worksite physical-activity interventions on neck-shoulder symptoms , together with perceived work ability and sick leave among office workers . METHODS An examiner-blinded r and omized controlled trial was conducted with 549 office workers allocated to one of three intervention groups : one with specific resistance training ( SRT ) of the neck-shoulder region ( N=180 ) , one with all-round physical exercise ( APE ) ( N=187 ) , and one which acted as a reference group , which was informed about general health-promoting activities but did not include a physical activity program ( N=182 ) . Question naires were filled out at baseline and after 1 year of training . RESULTS The duration and intensity of neck and shoulder symptoms was lower after the specified worksite physical-activity interventions than in the reference group . On an intervention group level , SRT was not more effective than APE in reducing the duration and intensity of neck and shoulder symptoms . However , those asymptomatic at baseline had a significant lower prevalence of neck-shoulder symptoms at follow-up when allocated to the SRT group than placed in the APE group or reference group . At baseline the work ability index ( WAI ) was close to 90 % of the maximum score , and the mean sick leave was 5 days per year , both being unaffected by the interventions . CONCLUSIONS Different physical-activity interventions were successful in reducing neck-shoulder symptoms , and SRT was superior to APE in the primary prevention of such symptoms . The initially relatively high WAI was the most probable reason for no further increase in WAI . Likewise the mean sick leave the year before the intervention was very low , and it was probably not possible to reduce it further",
"The effect of \" neck school \" on neck and shoulder disorders was studied in medical secretaries . A neck school reinforced with compliance enhancing measures ( group B ) was compared with a traditional neck school ( group A ) and a control group ( group C ) . The results show that ergonomical knowledge was good even before the secretaries attended the neck schools and that compliance was significantly higher for group B. When comparisons were made within groups some improvements on neck and shoulder fatigue and pain were noted , particularly for group B. When workload was controlled no significant group differences were found . No differences were noted for range of neck motion , or sick leave in any group . Our conclusion is that neck schools , despite good compliance , appear to be of limited clinical value for prevention of neck and shoulder disorders",
"OBJECTIVE To explore the effectiveness of naturopathic care ( NC ) on rotator cuff tendinitis using a prospect i ve r and omized clinical trial design . METHODS Canadian postal workers with rotator cuff tendinitis for a duration of > 6 weeks were r and omized to receive NC ( n = 43 ) or st and ardized physical exercises ( PEs ; n = 42 ) over 12 weeks . Participants in the NC group received dietary counseling , acupuncture , and Phlogenzym ( 2 tablets 3 times/day ) . The PE intervention group received passive , active-assisted , and active range of motion exercises and matched placebo . The primary outcome measure was the Shoulder Pain and Disability Index ( SPADI ) , and secondary outcomes were the pain visual analog scale ( VAS ) , Short Form 36 ( SF-36 ) , Measure Yourself Medical Outcomes Profile ( MYMOP ) , and shoulder maximal range of motion . Participants and assessors were blinded to group and placebo allocation . RESULTS Seventy-seven participants ( 87 % ) completed > or=8 weeks of the trial . Final total SPADI scores decreased by 54.5 % ( P SPADI scores showed statistically significant decreases in shoulder pain and disability in the NC group compared with the PE group ( P pain VAS , MYMOP , SF-36 , and shoulder extension , flexion , and abduction , with the NC group showing superiority in each outcome . No serious adverse reactions were observed . CONCLUSION NC and PE provided significant improvements , with greater improvement in shoulder function in the NC group compared with the PE group . Statistically significant improvements in quality of life measures were observed in the NC group as compared with the PE group",
"One hundred and eleven females volunteered to take part in this intervention study of musculoskeletal pain . They all completed a survey of pain among five hundred and eighty-six female hospital staff and presented mild to severe pain in the neck , shoulder and /or low back . They were r and omly assigned to one of the following groups ; Focus on job-stress and psychosocial coping ( Cognitive ) , relaxation training ( Relaxation ) , the combination of the two ( Combined ) or to a control group ( Control ) . Musculoskeletal pain ( intensity and duration ) was assessed by self-report prior to interventions , immediately after interventions , and at a four months follow-up . Results from multivariate analyses of variance as well as covariance ( pre-intervention levels of pain as covariate ) showed that magnitude of pain reduction was dependent upon the interaction between area of the back and type of intervention . These trends were more significant for intensity than for duration scores . They were due to reductions of pain in ( 1 ) neck and shoulders for the Cognitive and Combined groups and ( 2 ) in the low back and shoulders for the Relaxation group . The four month follow-up assessment revealed a significant risk of relapse only for duration of low back pain among subjects in the Combined group . Results from the Cognitive approach to intervention may reflect a causal role for ability to cope with psychosocial job stress in the development of neck and shoulder pain in female hospital staff"
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CONTEXT The literature provides no clear answer as to whether low endogenous testosterone increases risk of cardiovascular disease ( CVD ) in healthy men . OBJECTIVE Our purpose was to estimate the predictive value of testosterone for CVD and to identify study features explaining conflicting results . DATA SOURCES Articles were identified by a Medline and Embase search and citation tracking . STUDY SELECTION Eligible were prospect i ve population -based cohort and nested case-control studies of testosterone and atherosclerosis , stroke , myocardial infa rct ion , ischaemic heart disease , death from coronary heart disease or mortality . DATA EXTRACTION Two independent research ers re-expressed associations of testosterone and CVD in a uniform manner to be used in meta-regression analyses for identification of study features explaining conflicting results , and to estimate the predictive value of testosterone for CVD . RESULTS AND CONCLUSIONS 19 potentially eligible articles were identified . Overall , a weak independent association was found with an estimated summary RR of 0.89 for a change of one st and ard deviation in total testosterone level ( 95 % CI 0.83 to 0.96 ) . Age of study population and year of publication modified the relationship between testosterone and CVD . The estimated summary RR was 1.01 ( 0.95 to 1.08 ) for studies of men younger than 70 years of age , and 0.84 ( 0.76 to 0.92 ) for studies including men over 70 years of age . The latter studies showed a particular pronounced association if published after 1 January 2007 . Results were largely confirmed by separate analyses of free- and bioavailable testosterone . The systematic review displayed no association between endogenous testosterone and risk for CVD in middle-aged men . In elderly men , testosterone may weakly protect against CVD . Alternatively , low testosterone may indicate a poor general health
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"CONTEXT Lower circulating testosterone concentrations are associated with metabolic syndrome , type 2 diabetes , carotid intima-media thickness , and aortic and lower limb arterial disease in men . However , it is unclear whether lower testosterone levels predict major cardiovascular events . OBJECTIVE We examined whether lower serum testosterone was an independently significant risk factor for symptomatic cerebrovascular events in older men . DESIGN This was a prospect i ve observational study with median follow-up of 3.5 yr . SETTING Community-dwelling , stroke-free older men were studied . PARTICIPANTS A total of 3443 men at least 70 yr of age participated in the study . MAIN OUTCOME MEASURES Baseline serum total testosterone , SHBG , and LH were assayed . Free testosterone was calculated using mass action equations . Incident stroke or transient ischemic attack ( TIA ) was recorded . RESULTS A first stroke or TIA occurred in 119 men ( 3.5 % ) . Total and free testosterone concentrations in the lowest quartiles ( event-free survival ( P = 0.014 and P = 0.01 , respectively ) . After adjustment including age , waist-hip ratio , waist circumference , smoking , hypertension , dyslipidemia , and medical comorbidity , lower total testosterone predicted increased incidence of stroke or TIA ( hazard ratio = 1.99 ; 95 % confidence interval , 1.33 - 2.99 ) . Lower free testosterone was also associated ( hazard ratio = 1.69 ; 95 % confidence interval , 1.15 - 2.48 ) , whereas SHBG and LH were not independently associated with incident stroke or TIA . CONCLUSIONS In older men , lower total testosterone levels predict increased incidence of stroke or TIA after adjusting for conventional risk factors for cardiovascular disease . Men with low-normal testosterone levels had increased risk . Further studies are warranted to determine whether interventions that raise circulating testosterone levels might prevent cerebrovascular disease in men",
"CONTEXT Declining testosterone levels in elderly men are thought to underlie many of the symptoms and diseases of aging ; however , studies demonstrating associations of low testosterone with clinical outcomes are few . OBJECTIVE The objective of the study was to examine the association of endogenous testosterone levels with mortality in older community-dwelling men . DESIGN , SETTING , AND PARTICIPANTS This was a prospect i ve , population -based study of 794 men , aged 50 - 91 ( median 73.6 ) yr who had serum testosterone measurements at baseline ( 1984 - 1987 ) and were followed for mortality through July 2004 . MAIN OUTCOME MEASURE All-cause mortality by serum testosterone level was measured . RESULTS During an average 11.8-yr follow-up , 538 deaths occurred . Men whose total testosterone levels were in the lowest quartile ( die than those with higher levels , independent of age , adiposity , and lifestyle . Additional adjustment for health status markers , lipids , lipoproteins , blood pressure , glycemia , adipocytokines , and estradiol levels had minimal effect on results . The low testosterone-mortality association was also independent of the metabolic syndrome , diabetes , and prevalent cardiovascular disease but was attenuated by adjustment for IL-6 and C-reactive protein . In cause-specific analyses , low testosterone predicted increased risk of cardiovascular ( HR 1.38 ; 95 % CI 1.02 - 1.85 ) and respiratory disease ( HR 2.29 ; 95 % CI 1.25 - 4.20 ) mortality but was not significantly related to cancer death ( HR 1.34 ; 95 % CI 0.89 - 2.00 ) . Results were similar for bioavailable testosterone . CONCLUSIONS Testosterone insufficiency in older men is associated with increased risk of death over the following 20 yr , independent of multiple risk factors and several preexisting health conditions",
"BACKGROUND Low serum testosterone is a common condition in aging associated with decreased muscle mass and insulin resistance . This study evaluated whether low testosterone levels are a risk factor for mortality in male veterans . METHODS We used a clinical data base to identify men older than 40 years with repeated testosterone levels obtained from October 1 , 1994 , to December 31 , 1999 , and without diagnosed prostate cancer . A low testosterone level was a total testosterone level of less than 250 ng/dL ( free testosterone level of less than 0.75 ng/dL ( testosterone level ( 166 [ 19.3 % ] ) , an equivocal testosterone level ( equal number of low and normal levels ) ( 240 [ 28.0 % ] ) , or a normal testosterone level ( 452 [ 52.7 % ] ) . The risk for all-cause mortality was estimated using Cox proportional hazards regression models , adjusting for demographic and clinical covariates over a follow-up of up to 8 years . RESULTS Mortality in men with normal testosterone levels was 20.1 % ( 95 % confidence interval [ CI ] , 16.2%-24.1 % ) vs 24.6 % ( 95 % CI , 19.2%-30.0 % ) in men with equivocal testosterone levels and 34.9 % ( 95 % CI , 28.5%-41.4 % ) in men with low testosterone levels . After adjusting for age , medical morbidity , and other clinical covariates , low testosterone levels continued to be associated with increased mortality ( hazard ratio , 1.88 ; 95 % CI , 1.34 - 2.63 ; P equivocal testosterone levels were not significantly different from normal testosterone levels ( hazard ratio , 1.38 ; 95 % CI , 0.99%-1.92 % ; P=.06 ) . In a sensitivity analysis , men who died within the first year ( 50 [ 5.8 % ] ) were excluded to minimize the effect of acute illness , and low testosterone levels continued to be associated with elevated mortality . CONCLUSIONS Low testosterone levels were associated with increased mortality in male veterans . Further prospect i ve studies are needed to examine the association between low testosterone levels and mortality",
"Background —There is a popular belief that chronic stress causes heart disease through psychoneuroendocrine mechanisms . We have examined whether an elevated circulating cortisol-to-testosterone ratio increases the risk of ischemic heart disease . Methods and Results —We undertook a prospect i ve cohort study of 2512 men aged 45 to 59 years between 1979 and 1983 from Caerphilly , South Wales , with a mean follow-up of 16.5 years . Subjects underwent a clinical examination , and morning fasting blood sample s were taken for analysis of cortisol levels , testosterone levels , and other cardiovascular risk factors . The ratio of cortisol to testosterone showed weak associations with potential confounding factors but strong positive associations with components of the insulin resistance syndrome ( P cortisol : testosterone ratio for incident ischemic heart disease ( age-adjusted OR per z score change in ratio 1.22 , 95 % CI 1.07 to 1.38 , P=0.003 ) . This was markedly attenuated after adjustment for components of the insulin resistance syndrome ( age-adjusted OR per z score change in ratio 1.10 , 95 % CI 0.96 to 1.25 , P=0.18 ) . There was no association between the cortisol : testosterone ratio and other causes of death ( age-adjusted hazard ratio 0.99 , 95 % CI 0.88 to 1.11 , P=0.81 ) . Conclusions —This is the first population -based prospect i ve study that has found a specific association between cortisol : testosterone ratio and incident ischemic heart disease , apparently mediated through the insulin resistance syndrome . Whether this reflects the effects of chronic stress , behavioral factors , or genetic influences remains to be determined",
"CONTEXT Age-related reduction of serum testosterone may contribute to the signs and symptoms of aging , but previous studies report conflicting evidence about testosterone levels and male mortality . No large prospect i ve cohort study has determined a possible association between serum estradiol and mortality in men . OBJECTIVE The main objective was to examine the association between serum testosterone and estradiol and all-cause mortality in elderly men . DESIGN , SETTING , AND PARTICIPANTS We used specific gas chromatography-mass spectrometry to analyze serum sex steroids at baseline in older men who participated in the prospect i ve population -based MrOS Sweden cohort ( n = 3014 ; mean age , 75 yr ; range , 69 - 80 yr ) . MAIN OUTCOME MEASURE All-cause mortality by serum testosterone and estradiol levels . RESULTS During a mean follow-up period of 4.5 yr , 383 deaths occurred . In multivariate hazards regression models , low levels ( within quartile 1 vs. quartiles 2 - 4 ) of both testosterone [ hazard ratio ( HR ) , 1.65 ; 95 % confidence interval ( CI ) , 1.29 - 2.12 ] and estradiol ( HR , 1.54 ; 95 % CI , 1.22 - 1.95 ) associated with mortality . A model including both hormones showed that both low testosterone ( HR , 1.46 ; 95 % CI , 1.11 - 1.92 ) and estradiol ( HR , 1.33 ; 95 % CI , 1.02 - 1.73 ) predicted mortality . Risk of death nearly doubled ( HR , 1.96 ; 95 % CI , 1.46 - 2.62 ) in subjects with low levels of both testosterone and estradiol compared with subjects within quartiles 2 - 4 of both hormones . CONCLUSIONS Elderly men with low serum testosterone and estradiol have increased risk of mortality , and subjects with low values of both testosterone and estradiol have the highest risk of mortality",
"It has been hypothesized that hyperestrogenemia may underlie myocardial infa rct ion . As a test of this hypothesis , the serum estradiol and testosterone levels were estimated in sample s collected prospect ively from 96 male patients aged 52 - 74 years [ mean age 60.8 + /- 6.3 ( SD ) ] who had had a myocardial infa rct ion and from 96 matched control subjects in the Honolulu Heart Program . Established risk factors for myocardial infa rct ion were measured prospect ively . No significant difference between patients and control subjects in mean estradiol or testosterone level was observed . The only established risk factor that was significantly different was blood pressure , which was higher in the patients . Thus , the data did not confirm the hypothesis . However , two major pitfalls for prospect i ve studies of estradiol in myocardial infa rct ion , which might have affected the validity of the results , were observed , namely , deterioration of estradiol values with prolonged storage ( 8.5 - 12 years in this study ) and intervention . The value of this study , therefore , may lie in pointing out difficulties in carrying out prospect i ve studies on sex hormones",
"Circulating testosterone levels ( T ) decrease with age in men . Low T has been associated with coronary disease and with risk factors for atherosclerosis . This study examines the relationship in men between and rogenic hormones and arterial stiffness , a major risk factor for cardiovascular events . T , sex hormone-binding globulin ( SHBG ) , and dehydroepi and rosterone sulfate ( DHEAS ) were measured longitudinally over 33 yr ( follow-up 11.8 + /- 8.3 yr ) in 901 men from the Baltimore Longitudinal Study of Aging , of whom 206 ( 68.1 + /- 13.7 yr ) underwent carotid duplex ultrasonography . The 901 men were used to characterize age-associated hormone levels by means of mixed-effects models . Hormone values were estimated for the 206 men at the time of ultrasonography . Free T index ( FTI ) was calculated by dividing T by SHBG . The arterial stiffness index was calculated from peak systolic and end diastolic diameters of the common carotid artery and simultaneous brachial artery blood pressure . T , FTI , and DHEAS were correlated negatively with age , pulse pressure ( PP ) , and stiffness index ( each P age and stiffness index ( P stiffness index after adjustment for age , PP , fasting plasma glucose , body mass index , and total cholesterol . T values 5 - 10 yr before the carotid study also predicted the stiffness index ( P system in men may be mediated in part via the effects of T on vascular structure and function",
"Context Studies of the role of endogenous sex hormones in cardiovascular disease ( CVD ) in men have been inconclusive . Contribution A total of 2084 men from 2 Framingham Heart Study cohorts had levels of total serum estrogen , testosterone , and dehydroepi and rosterone sulfate ( DHEA-S ) measured in 1981 to 1985 for the original cohort and in 1987 to 1991 for the offspring cohort . Testosterone and DHEA-S levels were not associated with CVD risk . Estrogen levels were inversely related : Risk for CVD in the highest quartile was 0.68 ( 95 % CI , 0.50 to 0.92 ) times that in the lowest level . Caution s Investigators studied only white men and did not study free unbound hormone levels . Implication s Endogenous estrogen may be vasculoprotective in men , which is in contrast to the effects of exogenous estrogen . The Editors Male sex is an independent risk factor for cardiovascular disease ( CVD ) ( 1 ) . Scientists have postulated that the 5- to 10-year lag period in CVD incidence in women ( compared with men ) may be related to differences in endogenous sex hormones ( 27 ) . Indeed , substantial evidence suggests that sex hormones ( testosterone , estrogen , and dehydroepi and rosterone sulfate [ DHEA-S ] ) influence traditional and newer CVD risk factors ( 27 ) . Interest in the role of sex hormones in the pathogenesis of CVD has been rekindled by the observation that men with genetic defects of estrogen synthesis ( 8) or action ( 9 ) develop premature atherosclerosis . In addition , genetic variation in estrogen receptor- has been associated with prevalent CVD ( 10 , 11 ) , and and rogen and estrogen receptor expression in coronary arteries has been reported to influence coronary atherosclerosis in men ( 12 ) . In contrast to the aforementioned data , prospect i ve studies relating circulating sex hormone levels to incident CVD in men have been inconclusive . For example , low serum testosterone levels have been associated with greater progression of sub clinical atherosclerosis in 2 previous investigations ( 13 , 14 ) , but other studies have reported no association of testosterone levels with CVD events ( 1521 ) . On a parallel note , low DHEA-S levels have been linked to greater CVD risk in some studies ( 18 , 2224 ) but not in other studies ( 13 , 20 , 2529 ) . Investigations relating serum estradiol levels to CVD risk in men have generally found no statistically significant association ( 1520 ) . Some previous investigations were limited by modest sample sizes ( 14 , 17 , 18 , 22 , 25 , 26 ) ; an insufficient number of CVD events ( 1518 , 22 , 23 , 26 ) ; and , in some instances , a retrospective study design ( 1721 , 25 , 26 ) . In addition , some reports ( 15 , 22 , 24 ) focused on CVD death ( they did not evaluate nonfatal CVD events ) . Thus , a large prospect i ve community-based study relating sex hormones to CVD risk with adequate power to detect modest potential associations is needed . Accordingly , we evaluated the associations of serum levels of sex hormones that were measured at a routine baseline examination with CVD incidence in a prospect ively assembled cohort of participants . Methods Study Sample The Framingham Heart Study , a prospect i ve study of the risk factors for the development of heart disease and stroke , began in 1948 with the recruitment of 5209 men and women between 30 and 60 years of age who resided in Framingham , Massachusetts ( 30 ) . The Framingham Offspring Study began in 1971 with the recruitment of 5124 participants who were the children of the original cohort and the spouses of the children ( 31 ) . Participants in the original cohort are examined every 2 years , while offspring cohort members are assessed every 4 years . At each Framingham Heart Study examination , attendees undergo a physical examination and laboratory assessment of risk factors ( 31 ) . We evaluated 2789 men who attended the 17th biennial examination ( 19811983 ) of the original cohort or the fourth quadrennial examination ( 19871991 ) of the offspring cohort . We measured serum total testosterone and estradiol levels at these examinations , and we measured DHEA-S levels at the 18th examination ( 19831985 ) for the original cohort and at the fourth examination for the offspring cohort . We excluded 705 men because of prevalent CVD ( n= 541 ) and nonavailable testosterone data ( n= 164 ) . After exclusions , 2084 men ( 74.7 % ; 525 original cohort participants ) without previous CVD were eligible . Data on serum estradiol levels and serum DHEA-S levels were available in 2047 men and 1928 participants , respectively . All participants gave written informed consent , and the institutional review board at the Boston Medical Center approved the study protocol . Biochemical Assessment of Sex Hormones As described previously ( 32 ) , we measured total testosterone , total estradiol , and DHEA-S levels from serum sample s by using radioimmunoassays ( Diagnostic Products Corp. , Los Angeles , California ) for total testosterone ( interassay coefficient of variation , 11 % ) , total estradiol ( interassay coefficient of variation , 4 % ) , and DHEA-S ( interassay coefficient of variation , 11 % ) . We also measured serum luteinizing hormone levels at the baseline examinations ( interassay coefficient of variation , 6 % ) . Cardiovascular Outcomes All participants were under continuous surveillance for the occurrence of CVD events and death . Participants are evaluated periodically at the Framingham Heart Study and through health history up date s between examinations ( obtained via telephone interviews ) . Three experienced investigators obtained and review ed hospitalization and physician office visit records . We defined incident CVD as coronary heart disease ( recognized or unrecognized myocardial infa rct ion , angina pectoris , coronary insufficiency , or coronary heart disease death ) , cerebrovascular disease ( stroke or transient ischemic attack ) , congestive heart failure ( by Framingham criteria ) , or peripheral vascular disease ( intermittent claudication ) . Criteria for the diagnoses of cardiovascular events have been described elsewhere ( 33 ) . We considered that an unrecognized myocardial infa rct ion occurred if we found electrocardiographic evidence of clinical ly significant loss of R waves or appearance of pathologic Q waves on serial tracings in the absence of a clinical ly recognized event ( 33 ) . We defined the follow-up period a priori as 10 years from the baseline examination ( up to 1995 for the original cohort and 2002 for the offspring cohort ) to permit equal duration s of follow-up of original and offspring cohort participants and because sex hormone levels change considerably with age ( 34 ) . The analyses that combined the original and offspring cohorts had greater statistical power and allowed us to evaluate participants over a wider age range . Statistical Analyses Serum testosterone levels were normally distributed . Serum estradiol and DHEA-S levels were skewed and were log-transformed . We examined the associations between baseline sex hormone levels and CVD incidence during follow-up ( separate analyses for each hormone ) . We chose incident CVD as the outcome because the effects of sex hormones are not limited to a given vascular territory and this maximized our statistical power and limited multiple statistical testing ( as opposed to analysis for each CVD component ) . We stratified all analyses by the cohort ( offspring cohort vs. original cohort ) . We verified that the assumption of proportionality of hazards was satisfied for each hormone . We calculated age- and multivariable-adjusted 10-year incidence rates for CVD for each hormone quartile ( 35 ) . We prespecified 2 types of models : Primary analyses evaluated the sex hormones as continuous variables to maximize statistical power ( model A ) , and additional analyses compared CVD risk in hormone quartiles 2 to 4 with that in quartile 1 ( referent ) ( model B ) . These models facilitated assessment of potential nonlinear relations . For each hormone , we used proportional hazards regression ( 36 ) that adjusted for 1 ) age alone and 2 ) age , smoking , systolic and diastolic blood pressure , antihypertensive medication use , ratio of total and high-density lipoprotein ( HDL ) cholesterol , diabetes mellitus , and body mass index ( BMI ) . We evaluated models adjusted for age alone because some risk factors may fall along the causal pathway from estradiol to CVD . Adjustment for BMI was performed because adiposity is a strong correlate of sex hormone levels ( 37 ) and of sex hormonebinding globulin ( 38 ) . Sex hormonebinding globulin strongly influences measurements of total circulating sex hormone levels and the amount of bound hormone versus free hormone . We also evaluated models without BMI as a covariate to assess whether adjustment for BMI attenuated relations of sex hormones with CVD and models that were adjusted additionally for the use of aspirin or lipid-lowering medications , alcohol consumption , and education level . We incorporated statistical interaction terms to evaluate effect modification by age , BMI , smoking status , systolic blood pressure , and total cholesterolHDL cholesterol ratio . To gain additional insights into potential nonlinearity of associations between hormone levels and CVD risk , we examined generalized additive Cox models using penalized splines ( 39 , 40 ) for hormones that were statistically significantly related to CVD risk . Because potential relationships of sex hormones to CVD risk may be mediated by the development of risk factors during follow-up , we prespecified examination of time-dependent Cox models ( updating established CVD risk factors [ covariates in the multivariable-adjusted proportional hazards regression ] every 4 years at follow-up examinations ) for analyses of any sex hormone that was statistically significantly related to CVD events in the initial analyses . Additional Analyses We performed secondary analyses relating CVD risk to the estradioltestosterone ratio ( 37 , 41 ) . In addition , we investigated whether hypogonadism was related to CVD risk . We defined hypogonadism empirically as a serum testosterone level less than 10.4 nmol/L (",
"OBJECTIVE The pathophysiological pathways from stress caused by psychosocial stress to IHD has not been dealt with very extensively . The objective of this study was to analyse the association between cortisol levels and progression in intima media thickness ( IMT ) . METHODS AND RESULTS In 1998 and 2002 , 95 participants went through a clinical investigation including ultrasound of the artery carotis communis . Progression in IMT was analysed in relation to levels of salivary cortisol in 1998 and the average levels of salivary cortisol in 1998/2002 . Further , the significance of conventional coronary risk factors , testosterone and dehydro-epi and rosterone sulphate ( DHEAS ) were evaluated . Among the men , only age and HDL-cholesterol ( negative ) were significantly correlated with progression in IMT . Among the women , awakening cortisol response was significantly correlated with progression in IMT . Testosterone and DHEAS were borderline significantly associated ( negatively ) with progression in IMT in both genders . CONCLUSION Progression in atherosclerosis were determined by different risk factors in women and men . The awakening cortisol response was of great importance to IMT progression in women but not in men",
"OBJECTIVES Previous studies have suggested that abnormal levels of cortisol and testosterone might increase the risk of serious somatic diseases . To test this hypothesis , we conducted a 5-year follow-up study in middle-aged men . METHODS A population -based cohort study conducted in 1995 amongst 141 Swedish men born in 1944 , in whom a clinical examination supplemented by medical history aim ed to disclose the presence of cardiovascular disease ( CVD ) ( myocardial infa rct ion , angina pectoris , stroke ) , type 2 diabetes and hypertension were performed at baseline and at follow-up in the year 2000 . In addition , salivary cortisol levels were measured repeatedly over the day . Serum testosterone concentrations were also determined . Using the baseline data , an algorithm was constructed , which classified the secretion pattern of cortisol and testosterone from each individual as being normal or abnormal . RESULTS By the end of follow-up , men with an abnormal hormone secretion pattern ( n = 73 ) had elevated mean arterial pressure ( P = 0.003 ) , fasting insulin ( P = 0.009 ) and insulin : glucose ratio ( P = 0.005 ) compared with men with a normal secretion pattern ( n = 68 ) . Body mass index , waist circumference , and waist : hip ratio were significantly elevated in both groups . However , the 5-year incidence of CVD , type 2 diabetes , and hypertension were significantly higher ( P cardiovascular-related events and type 2 diabetes",
"CONTEXT Estrogen treatment of men with prostate cancer is associated with increased cardiovascular morbidity and mortality ; however , the role of endogenous estrogen levels for atherosclerotic disease in men is unknown . OBJECTIVE The objective of the study was to determine whether endogenous serum estradiol ( E2 ) levels predict the progression of carotid artery intima-media thickness in men . DESIGN , SETTING AND PARTICIPANTS This was a population -based , prospect i ve cohort study ( the Atherosclerosis and Insulin Resistance study ) conducted in Göteborg , Sweden , among 313 Caucasian men without cardiovascular or other clinical ly overt diseases . Carotid artery intima-media thickness , an index of pre clinical atherosclerosis , was measured by ultrasound at baseline ( 58 yr of age ) and after 3 yr of follow-up . Serum sex hormone levels and cardiovascular risk factors ( body mass index , waist to hip ratio , systolic blood pressure , serum triglycerides , plasma c-peptide , and smoking status ) were assessed at study entry . INTERVENTION There was no intervention . MAIN OUTCOME MEASURES Association between baseline total and free E2 levels and progression of carotid intima-media thickness over 3 yr with adjustments for cardiovascular risk factors was measured . RESULTS In univariate analyses , both total and free E2 levels at baseline were positively associated with the annual change in intima-media thickness . In linear regression models including E2 and cardiovascular risk factors , low-density lipoprotein and high-density lipoprotein cholesterol and E2 were identified as independent predictors of progression of carotid artery intima-media thickness ( total E2 beta = 0.187 , P = 0.001 ; and free E2 beta = 0.183 , P = 0.003 ) . CONCLUSIONS Circulating E2 is a predictor of progression of carotid artery intima-media thickness in middle-aged men . Further studies are needed to investigate the role of endogenous E2 for incident cardiovascular disease events",
"Prior studies have reported men with coronary artery disease ( CAD ) to have elevated plasma levels of estrogens and reduced concentrations of dehydroepi and rosterone ( DHEA ) or DHEA-sulfate ( DHEAS ) . We investigated whether gonadal steroids or DHEAS are risk factors for CAD in men , using a prospect i ve design , in a well characterized population studied at regular intervals . We studied 46 men ( Cardiac group ) who developed CAD and 124 men ( Control group ) who remained free of CAD ( mean follow-up , 9.5 years ) . We measured testosterone ( T ) , estradiol ( E2 ) , and DHEAS , as well as plasma binding of T and E2 , in sample s stored before the onset of CAD ( Cardiac group ) or at matched times ( Control group ) . Body mass index , blood pressure , and total serum cholesterol were measured at each visit . Both systolic blood pressure ( SBP ; P less than 0.001 ) and cholesterol ( P less than 0.001 ) were increased in the Cardiac group , but no significant differences were found in total or free T or E2 , the ratio of E2/T , or DHEAS between the two groups . The difference in cholesterol was significant only in men less than or equal to 65 years old ( P less than 0.001 ) , and SBP only in men greater than 65 years old ( P less than 0.005 ) . Cholesterol ( P less than 0.05 ) and E2 ( P less than 0.001 ) appeared to decrease with age in the Cardiac , but not the Control , group . Moreover , total ( P less than 0.01 ) and free E2 ( P less than 0.05 ) were lower only in Cardiac men less than or equal to 55 years old . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The relation between sex hormone levels and subsequent risk of a major coronary event was studied in a nested case-control study among 163 men in the Multiple Risk Factor Intervention Trial who later had a major coronary event and in 163 controls . Cases and controls were matched for age , serum cholesterol level , r and omization group , r and omization date and clinic . Blood sample s were collected at baseline before r and omization and frozen at -70 degrees C. Follow-up extended over 6 to 8 years . Sixty-one patients had a nonfatal acute myocardial infa rct ion and 102 fatal infa rct ion . Total and free testosterone , total and free estradiol , and rostenedione and estrone concentrations were measured . There were no significant differences between cases and controls for any sex hormone level . There was also no difference in the ratio of testosterone to estradiol . Controlling for other cardiovascular risk factors did not change these results . These results do not support previous case-control studies of a relation between sex hormone levels and risk of heart attack among men",
"Although treatment with high dose exogenous sex hormones affects cardiovascular risk , the role of physiological levels of endogenous sex hormones in the development of atherosclerotic disease in men and women is unknown . Forty men and 43 women wit peripheral arterial disease and 88 age- and sex-matched controls were selected from participants in the Edinburgh Artery Study , a r and om survey of 1592 men and women ages 55 - 74 years from the general population . Compared with sex-matched controls , male cases had higher systolic blood pressure ( 155.5 mmHg vs. 138.7 mmHg ; p waist hip ratio ( 0.92 vs. 0.89 ; p smoking ( square root of packyears 2.14 vs. 1.03 ; p Mean estrone levels were slightly higher in male cases than controls ( 101.9 pmol/Liter vs. 92.1 pmol/Liter ; p = 0.09 ) , but this association lost significance after multivariate adjustment for age and body mass index . Mean levels of total and free testosterone , estradiol , and sex hormone binding globulin were not significantly different in cases compared with controls in either sex ( p > 0.1 ) . These results , in accordance with previous prospect i ve studies on coronary artery disease , do not support a role for physiological levels of endogenous sex hormones in the development of peripheral arterial disease in men or postmenopausal women",
"We investigated the role of adrenal and rogens , cortisol , testosterone and sex-hormone binding globulin ( SHBG ) as coronary risk factors using a nested case-control design . The study population consisted of 62 cases with cardiac end-points and 97 controls on placebo during the last 4 years in the Helsinki Heart Study . Serum concentrations of dehydroepi and rosterone , dehydroepi and rosterone sulfate ( DHEAS ) , and rostenedione , and rostanediol glucuronide , cortisol , testosterone , and SHBG at the first annual visit of the 5-year study period were determined by radioimmunoassays . The only significant difference was found in DHEAS , with cases having higher levels than controls ( P DHEAS levels were positively associated with smoking ( P alcohol consumption ( P triglyceride levels ( P systolic ( P diastolic ( P blood pressures , and negatively associated with age ( P HDL-cholesterol ( P CHD risk was studied using logistic regression analyses with the classical risk factors -- age , smoking , blood pressure , and lipid levels -- as covariates in the models . Studies of the joint effects of age and DHEAS disclosed that the risk associated with elevated DHEAS was confirmed to older men ( odds ratio ( OR ) 7.3 , 95 % , CI 2.3 - 23.3 ) . A similar analysis with smoking revealed that the DHEAS-related risk was mainly found in smokers ( OR 3.4 , 95 % CI 1.5 - 8.2 ) . One possible explanation for these results is that some form of mild steroid biosynthetic defect of the adrenals or functional adrenal hyperplasia associated with high DHEAS levels increases the CHD risk in this population",
"BACKGROUND Studies on the effect of estrogen on atherosclerotic coronary artery disease ( CAD ) risk in women have produced conflicting results . Similar confusion , but fewer data , exists on the effect of testosterone on CAD risk in men . METHODS We used 99mTc sestamibi single-photon emission computed tomography ( SPECT ) myocardial perfusion imaging to examine the acute effect of intravenous testosterone in 32 men ( mean age , 69.1 + /- 6.4 years ) with provocable myocardial ischemia on st and ard medical therapy . Patients performed 3 exercise ( n = 18 ) or adenosine ( n = 16 ) stress tests during the infusion of placebo or 2 doses of testosterone design ed to increase testosterone 2 or 6 times baseline . RESULTS Serum testosterone increased 137 + /- 58 % and 488 + /- 113 % , and estradiol levels increased 27 + /- 46 % and 76 + /- 57 % , ( P testosterone infusions . There were no differences among the placebo or testosterone groups in peak heart rate , systolic blood pressure , maximal rate pressure product , perfusion imaging scores , or the onset of ST-segment depression . CONCLUSIONS Acute testosterone infusion has neither a beneficial nor a deleterious effect on the onset and magnitude of stress-induced myocardial ischemia in men with stable CAD"
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Background Data from European countries consistently show that guideline -conform secondary prevention after stroke/transient ischemic attack is being realized in only 50–80 % of patients . Use of telemedicine to support long-term secondary prevention has been effective in other cardiovascular diseases . Aims We review ed current evidence for telemedical-supported strategies for the improvement of secondary prevention after stroke/transient ischemic attack . A systematic review was performed in accordance with the PRISMA statement search ing MEDLINE , the Cochrane Central Register of Controlled Trials , and reference lists of articles published until 18 May 2016 . R and omized controlled trials and observational studies were included if they analyzed the effect of a telemedical strategy for supporting secondary prevention after stroke/transient ischemic attack compared to usual care and reported primary ( behavior according to guidelines , e.g. , medication adherence ) or surrogate outcomes ( consequences of primary outcome , e.g. , blood pressure ) . Summary of review The review included 13 of 100 identified studies involving 2672 patients . Telemedical support mainly comprised telephone interventions , predominantly done by nurses . Outcomes were heterogeneous : medication adherence did not differ in one r and omized controlled trial ( p = 0.089 ) . Mortality was reported in one study and was significantly ( p patients non-participating in a web-based intervention . Four studies assessed blood pressure in a comparable way that allowed calculation of a meta- analysis . In that , telemedical intervention had a significant blood-pressure lowering effect compared to the control group ( mean difference −6.14 ( 95 % confidence interval −10.41 , −1.87 ) , p = 0.005 ) . Conclusions Telemedical-supported secondary prevention in cerebrovascular diseases might be effective but larger trials with st and ardized interventions and outcome measures including clinical endpoints are needed
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"Background and Purpose — Stroke Unit care improves stroke prognosis and is recommended for all patients with stroke . In rural areas , population -wide implementation of Stroke Units is challenging . Therefore , the TeleMedical Project for integrative Stroke Care ( TEMPiS ) was established in 2003 as a TeleStroke Unit network to overcome this barrier in Southeast Bavaria/Germany . Evaluation of its implementation between 2003 and 2005 had revealed improved process quality and clinical outcomes compared with matched hospitals without TeleStroke Units . Data on sustainability of these effects are lacking . Methods — Effects on the stroke care of the local population were analyzed by using data from official hospital reports . Prospect i ve registries from 2003 to 2012 describe processes and outcomes of consecutive patients with stroke and transient ischemic attack treated in TEMPiS hospitals . Quality indicators assess diagnostics , treatment , and outcome . Rates and timeliness of intravenous thrombolysis as well as data on teleconsultations and secondary interhospital transfers were reported over time . Results — Within the covered area , network implementation increased the number of patients with stroke and transient ischemic attack treated in hospitals with (Tele-)Stroke Units substantially from 19 % to 78 % . Between February 2003 and December 2012 , 54 804 strokes and transient ischemic attacks were treated in 15 regional hospitals , and 31 864 teleconsultations were performed . Intravenous thrombolysis was applied 3331 stroke cases with proportions increasing from 2.6 % to 15.5 % of all patients with ischemic stroke . Median onset-to-treatment times decreased from 150 ( interquartile range , 127–163 ) to 120 minutes ( interquartile range , 90–160 ) and door-to-needle times from 80 ( interquartile range , 68–101 ) to 40 minutes ( interquartile range , 29–59 ) . Conclusions — TeleStroke Units can provide sustained high- quality stroke care in rural areas",
"Objective : Despite evidence demonstrating that risk-factor management is effective in reducing recurrent cerebrovascular disease , there are very few structured care programmes for stroke survivors . The aim was to implement and evaluate an integrated care programme in stroke . Methods : 186 patients with stroke were r and omised to either the treatment ( integrated care ) or control ( usual care ) group and were followed up over 12 months . The Integrated Care for the Reduction of Secondary Stroke ( ICARUSS ) model of integrated care involved collaboration between a specialist stroke service , a hospital coordinator and a patient ’s general practitioner . The primary aim was to promote the management of vascular risk factors through ongoing patient contact and education . Results : In the 12 months poststroke , systolic blood pressure ( sBP ) decreased in the treatment group but increased in controls . The group difference was significant , and remained so when age , sex , disability and sBP at discharge were accounted for ( p = 0.04 ) . Treatment patients also exhibited better modification of body mass index ( p = 0.007 ) and number of walks taken ( p controls . Rankin scores indicated significantly reduced disability in treatment patients relative to controls in the year poststroke ( p = 0.003 ) . Conclusions : Through an integrated system of education , advice and support to both patient and GP , the ICARUSS model was effective in modifying a variety of vascular risk factors and therefore should decrease the likelihood or recurrent stroke or vascular event",
"Background and Purpose — Stroke unit treatment is effective in reducing death and dependency after stroke but is not available in many , particularly rural , areas . The implementation of a stroke network with telemedicine support was associated with improved outcome at 3 months . We report follow-up results at 12 and 30 months after acute stroke . Methods — Telemedical Project for Integrative Stroke Care ( TEMPiS ) consists of the set-up of specialized local stroke wards , continuous medical education , and telemedical consultation for patients with acute stroke by 2 stroke centers . In a prospect i ve , nonr and omized , intervention study , 5 community hospitals participating in the network were compared with 5 matched control hospitals without specialized stroke facilities or telemedical support . All patients with consecutive ischemic or hemorrhagic stroke admitted between July 2003 and March 2005 were evaluated . Outcome “ death and dependency ” was defined by death , institutional care , or disability ( Barthel index 3 ) . Results — We followed-up 3060 patients ( 1938 in TEMPiS and 1122 in control hospitals ) . Follow-up rates were 97.2 % after 12 months and 95.9 % after 30 months for death or institutional care , and 96.5 % after 12 months and 95.7 % after 30 months for death and dependency . In multivariable regression analysis , there was no significant effect of the TEMPiS intervention for reduced “ death or institutional care ” at 12 months ( OR , 0.89 ; 95 % CI , 0.75–1.07 ; P=0.23 ) and 30 months ( OR , 0.93 ; 95 % CI , 0.78–1.11 ; P=0.40 ) but a significant reduction of “ death and dependency ” at 12 months ( OR , 0.65 ; 95 % CI , 0.54–0.78 ; P specialized stroke wards , continuing education , and telemedicine in community hospitals offers long-term benefit for acute stroke patients",
"Purpose . We hypothesised that carers of stroke survivors who participate in the Web-based intervention , Caring∼Web © , would have higher well-being than non-Web users . We also postulated that those survivors whose carers participated in Caring∼Web would use fewer healthcare services . Method . A r and omised , two-group , repeated measures design was used . Subjects were recruited from four rehabilitation centres from which first-time stroke survivors were discharged to home in two Midwestern states . Of 144 carers screened , 103 carers of these survivors who were novice Internet users were assigned to a Web or non-Web user group . Seventy-three subjects completed the study . Intervention . Caring∼Web was a Web-based intervention of education and support provided to the Web user group for 1 year . A bi-monthly telephone survey collected data on all carers well-being ( perceived depression , life satisfaction ) and survivors healthcare service use ( self-reported provider and emergency department visits , hospital re-admissions , nursing home placement ) . Results . No statistical differences were found between the groups in carers well-being or in the number of provider visits for survivors . There were significant differences in emergency department visits ( p = 0.001 ) and hospital re-admissions ( p = 0.0005 ) related to the health of survivors . Conclusions . This Web-based intervention helped new carers make informed decisions about healthcare needs of stroke survivors , thus reducing service use",
"OBJECTIVES The purpose of this study was to assess the rate of death and hospitalization for heart failure ( HF ) 1 and 3 years after a r and omized trial of telephone intervention aim ed to improve education and compliance in stable patients with HF ended . BACKGROUND The long-term effects of HF programs are not well known . METHODS In all , 1,518 patients with HF were r and omized into the DIAL ( R and omized Trial of Phone Intervention in Chronic Heart Failure ) . After completion of the trial , patients were followed up to 3 years to assess major outcomes . Compliance with diet , weight control , and treatment was evaluated . The effect of the intervention on mortality and HF hospitalizations was assessed using relative risk ( RR ) , relative risk reduction , and Cox proportional hazards model for adjusting by potential confounders . RESULTS The rate of death or hospitalization for HF was lower in the intervention group ( 37.2 % vs. 42.6 % , RR : 0.81 , 95 % confidence interval [ CI ] : 0.69 to 0.96 ; p = 0.013 ) 1 and 3 years ( 55.7 % vs. 57.5 % , RR : 0.88 , 95 % CI : 0.77 to 1.00 ; p = 0.05 ) after the intervention ended . This benefit was mainly caused by a reduction in admission for HF ( 28.5 % vs. 35.1 % after 3 years , RR : 0.72 , 95 % CI : 0.60 to 0.87 ; p = 0.0004 ) . Patients who showed improvement in 1 or more of 3 key compliance indicators ( diet , weight control , and medication ) had lower risks of events . CONCLUSIONS The benefit observed during the intervention period persisted and was sustained 1 and 3 years after the intervention ended . This effect may be explained by the impact of the educational intervention on patients ' behavior and habits",
"Background Enhanced secondary preventive follow-up after stroke or transient ischemic attack ( TIA ) is necessary for improved adherence to recommendations regarding blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) levels . We investigated whether nurse-led , telephone-based follow-up was more efficient than usual care at improving BP and LDL-C levels at 12 months after hospital discharge . Methods We r and omized 537 patients to either nurse-led , telephone-based follow-up ( intervention ) or usual care ( control ) . BP and LDL-C measurements were performed at 1 month ( baseline ) and 12 months post-discharge . Intervention group patients who did not meet target values at baseline received additional follow-up , including titration of medication and lifestyle counselling , to reach treatment goals ( BP , LDL-C 2.5 mmol/L ) . Results At 12 months , mean systolic BP , diastolic BP and LDL-C was 3.3 ( 95 % CI 0.3 to 6.3 ) mmHg , 2.3 mmHg ( 95 % CI 0.5 to 4.2 ) and 0.3 mmol/L ( 95 % CI 0.1 to 0.4 ) lower in the intervention group compared to controls . Among participants with values above the treatment goal at baseline , the difference in systolic BP and LDL-C was more pronounced ( 8.0 mmHg , 95 % CI 4.0 to 12.1 , and 0.6 mmol/L , 95 % CI 0.4 to 0.9 ) . A larger proportion of the intervention group reached the treatment goal for systolic BP ( 68.5 vs. 56.8 % , p = 0.008 ) and LDL-C ( 69.7 % vs. 50.4 % , p Nurse-led , telephone-based secondary preventive follow-up , including medication adjustment , was significantly more efficient than usual care at improving BP and LDL-C levels by 12 months post-discharge . Trial Registration IS RCT N Registry IS RCT",
"Background : R and omised controlled trials have shown a beneficial effect of antihypertensive treatment on stroke recurrence . The effect of antihypertensive treatment on survival and recurrence in an unselected sample of the general population , using the General Practice Research Data base , was analysed . Methods : Cox regression estimating the effect of antihypertensive treatment on survival and stroke recurrence > 1 year among 44,244 first-ever strokes in the UK from 1997 to 2006 was adjusted by propensity score analysis considering gender , age , general practice , stroke year , drug prescriptions and diagnostic codes from other diseases . Results : The EU st and ardised stroke incidence was 118 per 100,000 ( 95 % CI = 117–120 ) . The 90-day case fatality was 19 % . By 90 days after stroke 20,147 ( 58 % ) were diagnosed as having hypertension , of whom 75 % had received antihypertensive treatment after stroke . After 5 years 68 % of the hypertensive stroke patients receiving antihypertensive treatment were alive , while this proportion for patients not prescribed antihypertensive treatment was 59 % . This could not be explained by potential confounders with an adjusted relative risk of 0.62 ( 95 % CI = 0.58–0.66 ; p adjusted relative risk of antihypertensive treatment on stroke recurrence after 1 year , which was observed in 35 % until 5 years after stroke , was 0.92 ( 95 % CI = 0.84–1.01 ; p = 0.092 ) . Conclusions : A high proportion of hypertensive stroke patients did not receive antihypertensive treatment . The protective effect of antihypertensive treatment on survival was higher in this general population than reported in r and omised controlled trials , while an effect of antihypertensive treatment on late stroke recurrence was borderline , but not significant",
"The effectiveness of methods to prevent stroke recurrence and of education focusing on learners ' needs has not been fully explored . The aims of this study were to assess the effects of such interventions among stroke patients and their primary caregivers and to evaluate the feasibility of a web-based stroke education program . The participants were 36 patients with a clinical diagnosis of ischemic stroke within 12 months post-stroke and their primary caregivers . The participants were r and omly assigned to either an experimental or a control group . The primary measures included blood chemistry , self-reported health behaviors , sense of control , and health motivation for stroke patients , and caregiver mastery for caregivers . To test the feasibility of the intervention program , the rates of participation and occurrence of technical problems were calculated . The experimental group tended to improve significantly more than the control group in terms of exercise , diet , sense of control and health motivation for the stroke patients and in terms of caregiver mastery for the primary caregivers . The rate of participation in the web-based program was 63.1 % . This program , which focuses on recurrence prevention in stroke patients and caregivers , has the potential to improve health behaviors for stroke patients",
"Background and Purpose — Stroke prevention clinics ( SPCs ) are not usually involved with the active management of hypertension , hyperlipidemia , diabetes , and smoking . The effect of consultations generated at SPCs on the adequacy of the management of these risk factors for stroke has not been well described , and few studies have long-term follow-up . Methods — We performed a prospect i ve study of 119 consecutive patients referred to an SPC for secondary prevention . One year after their baseline visit , patients were re-evaluated for the adequacy of the management of the above risk factors , and the proportion of improvement was assessed . Results — One-hundred twelve patients returned for their 1-year follow-up visit . Sixty-six were male , and the average age was 65 years . Hypertension was present in 83 patients , hyperlipidemia in 92 , diabetes in 26 , and smoking in 38 , and 80 had multiple risk factors . At baseline , 66 % of patients with hypertension , 17 % of patients with hyperlipidemia , and 23 % of diabetics had adequate management of their respective risk factors . During 1 year of follow-up , hypertension management improved 20 % ( P lipid management improved 32 % ( P improvement in diabetes management or smoking cessation . Conclusions — Although our underst and ing of the benefit of addressing hypertension , hyperlipidemia , diabetes , and smoking for secondary prevention of stroke is evolving , we found marked room for improvement in the management of these four risk factors . SPCs may need to be more actively involved in the management of these modifiable risk factors , if we are to significantly impact the risk of recurrent stroke",
"Background — Comparison of a multimodal intervention WE CALL ( study initiated phone support/information provision ) versus a passive intervention YOU CALL ( participant can contact a re source person ) in individuals with first mild stroke . Methods and Results — This study is a single-blinded r and omized clinical trial . Primary outcome includes unplanned use of health services ( participant diaries ) for adverse events and quality of life ( Euroquol-5D , Quality of Life Index ) . Secondary outcomes include planned use of health services ( diaries ) , mood ( Beck Depression Inventory II ) , and participation ( Assessment of Life Habits [ LIFE-H ] ) . Blind assessment s were done at baseline , 6 , and 12 months . A mixed model approach for statistical analysis on an intention-to-treat basis was used where the group factor was intervention type and occasion factor time , with a significance level of 0.01 . We enrolled 186 patients ( WE=92 ; YOU=94 ) with a mean age of 62.5±12.5 years , and 42.5 % were women . No significant differences were seen between groups at 6 months for any outcomes with both groups improving from baseline on all measures ( effect sizes ranged from 0.25 to 0.7 ) . The only significant change for both groups from 6 months to 1 year ( n=139 ) was in the social domains of the LIFE-H ( increment in score , 0.4/9±1.3 [ 95 % confidence interval , 0.1–0.7 ] ; effect size , 0.3 ) . Qualitatively , the WE CALL intervention was perceived as reassuring , increased insight , and problem solving while decreasing anxiety . Only 6 of 94 ( 6.4 % ) YOU CALL participants availed themselves of the intervention . Conclusions — Although the 2 groups improved equally over time , WE CALL intervention was perceived as helpful , whereas YOU CALL intervention was not used . Clinical Trial Registration — URL : http://www.controlled-trials.com . Unique identifier : IS RCT N95662526",
"Background and Purpose — Many stroke patients and informal carers experience a decreased quality of life after discharge home and are dissatisfied with the care received . We assessed the effectiveness of an outreach nursing care program . Methods — In a multicenter trial , 536 stroke patients were r and omized at discharge to st and ard care ( n=273 ) or st and ard care plus outreach care ( n=263 ) . The outreach care consisted of 3 telephone calls and 1 home visit within 5 months after discharge by 1 of 13 stroke nurses . Patients were masked for the trial objectives . Six months after discharge , they assessed the 2 primary outcomes : quality of life ( Short Form 36 [ SF-36 ] ) and dissatisfaction with care . Secondary measures of outcome were disability , h and icap , depression , anxiety , and use of health care services and secondary prevention drugs . Informal carers assessed strain , and social support . Analysis was by intention to treat . Results — Twelve patients died before follow-up , 38 declined outcome assessment , and 486 completed the primary outcome assessment s. Outreach care patients had better scores on the SF-36 domain “ Role Emotional ” than controls ( mean difference 7.9 [ 95 % confidence limit , 0.1 to 15.7 ] ) . No statistically significant differences were found on the other primary outcome measures . For secondary outcomes , no statistically significant differences were found , except that intervention patients used fewer rehabilitation services ( relative risk , 0.66 [ 0.44 to 1.00 ] ) and had lower anxiety scores ( median difference 1 [ 0.19 to 2.79 ] ) . Conclusions — This outreach nursing stroke care was not effective in improving quality of life and dissatisfaction with care of recently discharged patients",
"BACKGROUND hypertension is a common risk factor for stroke/transient ischaemic attack ( TIA ) and there is good evidence that blood pressure ( BP ) control prevents recurrent stroke . We investigated whether telephone follow-up ( TFU ) improved risk factor management in hypertensive patients after stroke/TIA . METHODS we conducted a r and omised controlled trial and assigned hypertensive patients within 1 month of stroke or TIA to receive usual care ( n = 27 ) or usual care plus regular TFU ( n = 29 ) . Primary outcome was the difference in 12 h ambulatory systolic BP change from baseline to 6 months ( DeltaSBP ) in both groups . TFU at 7 days , 1 , 2 and 4 months included patient-focussed education and goal setting . RESULTS mean baseline BP was 145/83 mm Hg ( st and ard deviation ( SD ) 21/14 ) . There was no significant difference in DeltaSBP over 6 months with TFU . Median DeltaSBP was 0 mm Hg ( interquartile range 19.5 ) in the TFU group and 3.0 mm Hg ( 20 ) fall in the usual care group ( P = 0.29 ) . Post hoc analysis showed that statin use increased from baseline to 6 months ( P = 0.02 ) and cholesterol was significantly lower at 6 months in all patients ( mean reduction 0.95 mmol/l ; P BP control over 6-month follow-up in primary care after stroke/TIA",
"Background and Purpose — Telemedicine techniques can be used to address the rural – metropolitan disparity in acute stroke care . The Stroke Team Remote Evaluation Using a Digital Observation Camera ( STRokE DOC ) trial reported more accurate decision making for telemedicine consultations compared with telephone-only and that the California-based research network facilitated a high rate of thrombolysis use , improved data collection , low risk of complications , low technical complications , and favorable assessment times . The main objective of the STRokE DOC Arizona TIME ( The Initial Mayo Clinic Experience ) trial was to determine the feasibility of establishing , de novo , a single-hub , multirural spoke hospital telestroke research network across a large geographical area in Arizona by replicating the STRokE DOC protocol . Methods — Methods included prospect i ve , single-hub , 2-spoke , r and omized , blinded , controlled trial of a 2-way , site-independent , audiovisual telemedicine system design ed for remote examination of adult patients with acute stroke versus telephone consultation to assess eligibility for treatment with intravenous thrombolysis . The primary outcome measure was whether the decision to give thrombolysis was correct . Secondary outcomes were rate of thrombolytic use , 90-day functional outcomes , incidence of intracerebral hemorrhages , and technical observations . Results — From December 2007 to October 2008 , 54 patients were assessed , 27 of whom were r and omized to each arm . Mean National Institutes of Health Stroke Scale score at presentation was 7.3 ( SD 6.2 ) points . No consultations were aborted ; however , technical problems ( 74 % ) were prevalent in the telemedicine arm . Overall , the correct treatment decision was established in 87 % of the consultations . Both modalities , telephone ( 89 % correct ) and telemedicine ( 85 % correct ) , performed well . Intravenous thrombolytic treatment was used in 30 % of the telemedicine and telephone consultations . Good functional outcomes at 90 days were not significantly different . There were no statistically significant differences in mortality ( 4 % in telemedicine and 11 % in telephone ) or rates of intracerebral hemorrhage ( 4 % in telemedicine and 0 % in telephone ) . Conclusions — It is feasible to extend the original STRokE DOC trial protocol to a new state and establish an operational single-hub , multispoke rural hospital telestroke research network in Arizona . The trial was not design ed to have sufficient power to detect a difference between the 2 consultative modes : telemedicine and telephone-only . Whether by telemedicine or telephone consultative modalities , there were appropriate treatment decisions , high rates of thrombolysis use , improved data collection , low rates of intracerebral hemorrhage , and equally favorable time requirements . The learning curve was steep for the hub and spoke personnel of the new telestroke network , as reflected by frequent technical problems . Overall , the results support the effectiveness of highly organized and structured stroke telemedicine networks for extending expert stroke care into rural remote communities lacking sufficient neurological expertise",
"Objective : To evaluate whether enhanced secondary prevention more significantly influences readiness to change health behaviour after minor stroke/transient ischaemic attack , compared with conventional stroke secondary prevention . Design : Single-blind r and omized control trial . Setting : Rural district general hospital outpatient clinic . Subjects : Fifteen women and 37 men with a mean age of 68.3 years with first minor stroke or transient ischaemic attack . Interventions : The intervention group received ‘ enhanced secondary prevention ’ ( additional advice , motivational interviewing and telephone support ) to change health behaviour . Both groups received ‘ conventional care ’ which included advice given during routine care . Main measures : The primary outcome was ‘ readiness to change behaviour ’ measured using a vali date d stroke specific score based on the transtheoretical model . Secondary outcomes were the Hospital Anxiety and Depression Scale , and self-reported alcohol consumption , smoking behaviour , exercise frequency , and fruit and vegetable consumption . Results : Analysis of the data for the 52 participants showed no statistical difference in the groups for the primary outcome of readiness to change behaviour . Statistically significant improvements for change in self-reported exercise were demonstrated ( P = 0.007 ) ; to 2—3 times per week in the intervention group compared to 0—1 times per week in the control group , and in fruit and vegetable consumption ( P = 0.033 ) ; to 10 portions of fruit and vegetables consumed per week in the intervention group compared to 1 or 2 portions a week for the control group . No evidence of a difference between groups was seen for alcohol consumption or Hospital Anxiety and Depression Scale . Conclusions : While no difference was demonstrated between the groups for readiness to change behaviour , a clinical ly significant effect in reported exercise behaviour and diet were demonstrated in the intervention group . This interesting finding indicates a dissonance between the behaviour scale and actual behaviour change , potentially indicating a lack of sensitivity of the scale to detect a change in this patient group",
"Background Introducing new technology in health care is inevitably a challenge . More knowledge is needed to better plan future telemedicine interventions . Our aim was therefore to explore health care professionals ’ experience in the initial phase of introducing telemedicine technology in caring for people with diabetic foot ulcers . Methods Our method ological strategy was Interpretive Description . Data were collected between 2014 and 2015 using focus groups ( n = 10 ) . Participants from home-based care , primary care and outpatient hospital clinics were recruited from the intervention arm of an ongoing cluster r and omized controlled trial ( RCT ) ( Clinical trials.gov : NCT01710774 ) . Most were nurses ( n = 29 ) , but the sample also included one nurse assistant , podiatrists ( n = 2 ) and physicians ( n = 2 ) . Results The participants reported experiencing meaningful changes to their practice arising from telemedicine , especially associated with increased wound assessment knowledge and skills and improved documentation quality . They also experienced more streamlined communication between primary health care and specialist health care . Despite obstacles associated with finding the documentation process time consuming , the participants ’ attitudes to telemedicine were overwhelmingly positive and their general enthusiasm for the innovation was high . Conclusions Our findings indicate that using a telemedicine intervention enabled the participating health care professionals to approach their patients with diabetic foot ulcer with more knowledge , better wound assessment skills and heightened confidence . Furthermore , it streamlined the communication between health care levels and helped seeing the patients in a more holistic way",
"OBJECTIVES It is evident that patients with atherosclerotic vascular disease ( AVD ) benefit from appropriate secondary prevention . In clinical reality , the secondary prevention in AVD patients other than those with coronary heart disease ( CHD ) is often overlooked . Therefore , we compared the adherence to secondary prevention principles between poststroke and CHD patients . STUDY DESIGN Descriptive ( cross-sectional ) study with prospect i ve mortality follow-up . METHODS We examined 1729 chronic patients with AVD ( mean age 65.9 ( ±SD 9.6 ) years ) , 964 with CHD , and 765 poststroke ( pooled data of Czech sample s of EUROASPIRE III , IV , and the ESH stroke survey ) . The interview was performed 6 - 36 months after the coronary event/revascularization or the first ischemic stroke , while the mortality follow-up 5 years after this interview . RESULTS Poststroke patients had a significantly higher risk of persistent smoking , blood pressure ≥140/90 mmHg and LDL ≥2.5 mmol/L than CHD patients [ odds ratios adjusted for age , gender and survey were 1.63 ( 95 % CI : 1.13 - 2.33 ) , 1.38 ( 95 % CI : 1.13 - 1.69 ) and 2.26 ( 95 % CI : 1.84 - 2.78 ) , respectively ] . In contrast , poststroke patients showed a lower risk of inappropriate glucose control and hypertriglyceridemia [ 0.66 ( 95%CI : 0.54 - 0.82 ) and 0.74 ( 95%CI : 0.61 - 0.91 ) , respectively ] . The prescription rates of antiplatelets/anticoagulants , antihypertensives and statins were also significantly lower in poststroke than in CHD patients ( 89.4 vs 93.7 , 85.9 vs 97.5 , and 57.7 vs 89.8 , respectively ) . Mortality analysis was performed in a sub sample of 815 subjects interviewed in 2006/07 . The 5-year all-cause mortality rates were 25.8 % and 13.3 % in poststroke and coronary patients , respectively ( P = 0.0023 ) ; the hazard ratio for stroke adjusted for major risk factors was 1.85 ( 95 % CI : 1.31 - 2.63 ) . CONCLUSIONS Compared to CHD patients , poststroke patients are strongly h and icapped in terms of poor adherence to secondary prevention target , prescription of basic pharmacotherapies and mortality risk",
"OBJECTIVES to test the hypothesis as to whether persons newly discharged into the community following an acute stroke and assigned a stroke case manager would experience , compared to usual post-hospital care , better health-related quality of life ( HRQL ) , fewer emergency room visits and less non-elective hospitalisations . DESIGN a stratified , balanced , evaluator-blinded , r and omised clinical trial . SETTING five university-affiliated acute-care hospitals in Montreal , Quebec , Canada . PARTICIPANTS persons ( n = 190 ) returning home directly from the acute-care hospital following a first or recurrent stroke with a need for health care supervision post-discharge because of low function , co-morbidity , or isolation . INTERVENTION for 6 weeks following hospital discharge a nurse stroke care manager maintained contact with patients through home visits and telephone calls design ed to coordinate care with the person 's personal physician and link the stroke survivor into community-based stroke services . MEASUREMENTS the primary outcome was the Physical Component Summary ( PCS ) of the Short-Form (SF)-36 survey . A secondary outcome was utilisation of health services . Also measured was the impact of stroke on functioning . Measurements were made at hospital discharge ( baseline ) , following the 6-week intervention and at 6-months post-stroke . RESULTS the average age of the participants was 70 years . Discharge was achieved on average 12 days post-stroke and most participants had had a stroke of moderate severity . There were no differences between groups on the primary outcome measure , health services utilisation , or any of the secondary outcome measures . CONCLUSION for this population , there was no evidence that this type of passive case management inferred any added benefit in terms of improvement in health-related quality of life or reduction in health services utilisation and stroke impact , than usual post-discharge management",
"PURPOSE The purpose of this study was to investigate the effects of the lifestyle modification coaching program on self efficacy , lifestyle and physiologic indexes related to the recurrence of stroke in patients with stroke . METHODS Sixty-one patients with stroke registered with a stroke center participated in this study . Of the participants , 32 were assigned to the experimental group and 29 to the control group . Self efficacy , alcohol drinking , smoking , physical activity , BMI ( body mass index ) , WHR ( waist-hip ratio ) , blood lipid level , and blood pressure were measured both for the baseline , as well as after intervention . The lifestyle modification coaching program consisted of an 8-week telecoaching session following face-to-face education . The control group received only the face-to-face education . RESULTS There were significant differences in physical activities , WHR , blood pressure within and between groups after intervention . The lifestyle modification coaching program had significant influences on blood pressure even after gender , age , and physical activity had been adjusted . CONCLUSION The results of the study indicate that lifestyle modification coaching program is effective for physical activity , abdominal obesity and blood pressure . Therefore it can be used by nurses in hospitals and communities as one of the secondary stroke prevention programs for patients with stroke",
"BACKGROUND The exp and ing role of technology to augment diabetes care and management highlights the need for clinicians to learn about these new tools . As these tools continue to evolve and enhance improved outcomes , it is imperative that clinicians consider the role of telemonitoring , or remote monitoring , in patient care . This article describes a successful telemonitoring project in Utah . SUBJECTS AND METHODS This was a nonr and omized prospect i ve observational preintervention-postintervention study , using a convenience sample . Patients with uncontrolled diabetes and /or hypertension from four rural and two urban primary care clinics and one urban stroke center participated in a telemonitoring program . The primary clinical outcome measures were changes in hemoglobin A1C ( A1C ) and blood pressure . Other outcomes included fasting lipids , weight , patient engagement , diabetes knowledge , hypertension knowledge , medication adherence , and patient perceptions of the usefulness of the telemonitoring program . RESULTS Mean A1C decreased from 9.73 % at baseline to 7.81 % at the end of the program ( P Systolic blood pressure also declined significantly , from 130.7 mm Hg at baseline to 122.9 mm Hg at the end ( P=0.0001 ) . Low-density lipoprotein content decreased significantly , from 103.9 mg/dL at baseline to 93.7 mg/dL at the end ( P=0.0263 ) . Other clinical parameters improved nonsignificantly . Knowledge of diabetes and hypertension increased significantly ( P Patient engagement and medication adherence also improved , but not significantly . Per question naires at study end , patients felt the telemonitoring program was useful . CONCLUSIONS Telemonitoring improved clinical outcomes and may be a useful tool to help enhance disease management and care of patients with diabetes and /or hypertension"
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41181120-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Although pharmacological and psychological interventions are both effective for major depression , antidepressant drugs are frequently used as first-line treatment in primary and secondary care setting s. Milnacipran , a dual serotonin-norepinephrine reuptake inhibitor ( SNRI ) , is one of the antidepressant drugs that clinicians use for routine depression care . OBJECTIVES To assess the evidence for the efficacy , acceptability and tolerability of milnacipran in comparison with tricyclic antidepressants ( TCAs ) , heterocyclics , SSRIs and other newer antidepressive agents in the acute-phase treatment of major depression . SEARCH STRATEGY The Cochrane Collaboration Depression , Anxiety & Neurosis review group Controlled Trials Register ( CCDANCTR- Studies and CCDANCTR-References ) were electronically search ed in August 2008 . References of relevant trials and other review s were also checked . Trial data bases of the drug-approving agencies and ongoing clinical trial registers for all published and unpublished trials were h and - search ed in 2007 . All relevant authors were contacted for supplemental data . No language restriction was applied . SELECTION CRITERIA R and omised controlled trials comparing milnacipran with any other active antidepressive agents ( including non-conventional agents such as herbal products like hypericum ) as monotherapy in the acute phase of major depression were selected . DATA COLLECTION AND ANALYSIS Two review ers independently checked eligibility , assessed method ological quality and extracted data from the eligible trials using a st and ardised data extraction form . The number of participants who responded to treatment or those who achieved remission were calculated on an intention-to-treat basis . R and om-effects meta-analyses were conducted , combining data from the included trials . MAIN RESULTS A total of 16 r and omised controlled trials ( n=2277 ) were included in the meta- analysis .Despite the size of this sample , the pooled 95 % confidence intervals were rather wide and there were no statistically significant differences in efficacy , acceptability and tolerability when comparing milnacipran with other antidepressive agents . However , compared with TCAs , patients taking milnacipran were associated with fewer dropouts due to adverse events ( OR 0.55 ; 95%CI 0.35 to 0.85 ) . There was also some weak evidence to suggest that patients taking milnacipran experienced fewer adverse events of sleepiness/ drowsiness , dry mouth or constipation compared with TCAs . AUTHORS ' CONCLUSIONS Currently , there is inadequate evidence to conclude whether milnacipran is superior , inferior or the same as other antidepressive agents in terms of efficacy , acceptability and tolerability in the acute phase treatment of major depression . However , there is some evidence in favour of milnacipran over TCAs in terms of dropouts due to adverse events ( acceptability ) and the rates of experiencing adverse events ( tolerability ) . Information about other clinical ly meaningful outcomes such as cost-effectiveness and social functioning , including the ability to return to work , is lacking . Further study is needed to answer whether milnacipran would be the better choice of antidepressant for acute major depression
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"CONTEXT Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions . OBJECTIVE To explore whether the association between funding and conclusions in r and omized drug trials reflects treatment effects or adverse events . DESIGN Observational study of 370 r and omized drug trials included in meta-analyses from Cochrane review s selected from the Cochrane Library , May 2001 . From a r and om sample of 167 Cochrane review s , 25 contained eligible meta-analyses ( assessed a binary outcome ; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment ) . The primary binary outcome from each meta- analysis was considered the primary outcome for all trials included in each meta- analysis . The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect , adverse events , and additional confounding factors ( method ological quality , control intervention , sample size , publication year , and place of publication ) . MAIN OUTCOME MEASURE Conclusions in trials , classified into whether the experimental drug was recommended as the treatment of choice or not . RESULTS The experimental drug was recommended as treatment of choice in 16 % of trials funded by nonprofit organizations , 30 % of trials not reporting funding , 35 % of trials funded by both nonprofit and for-profit organizations , and 51 % of trials funded by for-profit organizations ( P funding , treatment effect , and double blinding were the only significant predictors of conclusions . Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice ( odds ratio , 5.3 ; 95 % confidence interval , 2.0 - 14.4 ) compared with trials funded by nonprofit organizations . This association did not appear to reflect treatment effect or adverse events . CONCLUSIONS Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results . Readers should carefully evaluate whether conclusions in r and omized trials are supported by data",
"BACKGROUND Depression is now seen as a chronic disabling condition that spans the patient 's lifetime and creates significant medical , economic and quality of life consequences . METHODS 500 depressed patients were treated with milnacipran for 6 months . A total of 214 recovered patients were r and omised to receive either milnacipran ( 50 mg bid ) or a matching placebo for a 1-year recurrence prevention phase . Recurrence rate was the primary criteria ; quality of life ( QoL ) consequences were evaluated through a shortened version of the French Sickness Impact Profile ( SIP ) , the Depression Impact Profile ( DIP ) . RESULTS Milnacipran demonstrated its ability to reduce recurrences ( Odds-Ratio=1.5 ; P milnacipran had a dramatic improvement in their quality of life , although patients with residual symptoms still experienced some deterioration in their QoL ( recreation , emotional , social , alertness and home assistance scores ) . Even recovered patients having zero scores on the Hamilton Depression Rating Scale-21 items ( HDRS ) had some QoL deterioration . The DIP emotional score was found to be more predictive of recurrence than the HDRS . Overall , the QoL was improved for those in the milnacipran group in comparison to placebo on the mobility , communication , psycho-social and total scores . LIMITATIONS The QoL evaluation was a secondary criteria ; no a priori sample size estimate was performed . The choice of a generic QoL instrument might have reduced the sensitivity to clinical changes in depression . CONCLUSIONS Prevention of recurrence in MDD with milnacipran contributes to an improvement in the",
"Abstract Objective To examine the extent and nature of outcome reporting bias in a broad cohort of published r and omised trials . Design Retrospective review of publications and follow up survey of authors . Cohort All journal articles of r and omised trials indexed in PubMed whose primary publication appeared in December 2000 . Main outcome measures Prevalence of incompletely reported outcomes per trial ; reasons for not reporting outcomes ; association between completeness of reporting and statistical significance . Results 519 trials with 553 publications and 10 557 outcomes were identified . Survey responders ( response rate 69 % ) provided information on unreported outcomes but were often unreliable — for 32 % of those who denied the existence of such outcomes there was evidence to the contrary in their publications . On average , over 20 % of the outcomes measured in a parallel group trial were incompletely reported . Within a trial , such outcomes had a higher odds of being statistically non-significant compared with fully reported outcomes ( odds ratio 2.0 ( 95 % confidence interval 1.6 to 2.7 ) for efficacy outcomes ; 1.9 ( 1.1 to 3.5 ) for harm outcomes ) . The most commonly reported reasons for omitting efficacy outcomes included space constraints , lack of clinical importance , and lack of statistical significance . Conclusions Incomplete reporting of outcomes within published articles of r and omised trials is common and is associated with statistical non- significance . The medical literature therefore represents a selective and biased subset of study outcomes , and trial protocol s should be made publicly available",
"Milnacipran is a new antidepressive drug , a combined noradrenaline/serotonin ( NA/5‐HT ) reuptake inhibitor , which has been suggested to be as effective as and better tolerated than tricyclic antidepressants . Since long‐term studies are lacking , we compared the efficacy , safety and tolerability of milnacipran and clomipramine in a double‐blind , r and omized , parallel‐group study setting during 26 weeks of treatment in patients with major depression . A total of 107 patients were treated with either milnacipran ( n=52 ) or clomipramine ( n=55 ) . Due to active treatment of duration less than 12 days in four patients and protocol deviation in one patient , in total 47 milnacipran‐treated patients were eligible for efficacy analysis . Nine patients in the clomipramine group continued on active treatment for less than 12 days . Thus 46 clomipramine‐treated patients were finally included in the efficacy analysis . After 1 week of dose escalation , there was a fixed dosage regimen of either milnacipran ( 200 mg daily ) or clomipramine ( 150 mg daily ) during weeks 2 to 10 , followed by flexible dosing of milnacipran ( 100,150 or 200 mg daily ) or clomipramine ( 75 , 100 or 150 mg daily ) during weeks 11 to 26 . A total of 53 patients ( 49 % ) completed the 26‐week study period ; 21 % ( 11/52 ) of the patients in the milnacipran group and 38 % ( 21/55 ) of the patients in the clomipramine group discontinued their medication prematurely due to adverse events , whereas 19 % ( 10/52 ) of those on milnacipran and 7 % ( 4/55 ) of those on clomipramine treatment withdrew due to either lack of efficacy or clinical deterioration . The mean change ( ±SD ) in the Hamilton Depression Rating Scale ( HAMD ) score between the baseline and the last rating ranged from 23.7±3.1 to 12.0±9.5 in the milnacipran‐treated patients and from 23.1±3.5 to 8.0±8.5 in the clomipramine‐treated patients , revealing a significant difference in favour of clomipramine . In total 58 % of the milnacipran‐treated patients vs. 72 % of the clomipramine‐treated patients showed a ≥50 % reduction in their baseline HAMD scores and 45 % vs. 63 % had an HAMD score of ≤7 at the last rating , respectively . Moreover , the time to the onset of the antidepressant action ( defined as ≥50 % reduction of the baseline HAMD score ) showed a significant difference in favour of clomipramine . In addition , clomipramine was significantly more efficacious in patients with a baseline HAMD score of ≥24 as evidence d by the analysis of the HAMD score at week 6 and at the last rating . The Montgomery Åsberg Depression Rating Scale ( MADRS ) and the Clinical Global Impression ( CGI ) scale did not show significant differences between the treatment groups . The safety analysis did not reveal any differences of clinical significance in cardiovascular variables between the study drugs . Dry mouth was significantly less frequently reported by the milnacipran‐treated patients during the early and later phases ( weeks 6 to 26 ) of the study , while insomnia was more common in the milnacipran group during weeks 1 to 6 . In conclusion , milnacipran appeared to be less effective than clomipramine in the long‐term treatment of depression . The side‐effects of the drugs differed to a certain extent , and milnacipran tended to be somewhat better tolerated than clomipramine ",
"Milnacipran is a new potential antidepressant selected for its equipotent inhibition of noradrenaline and serotonin uptake and its lack of effect at any postsynaptic receptor . We recently compared milnacipran 100 and 50 mg/d and amitriptyline 150 mg/d in three parallel r and omized groups of major depressive in patients and found a statistically significant superiority of milnacipran 100 mg/d and amitriptyline over milnacipran 50 mg/d after 4 weeks of treatment . Later on we found similar improvement with milnacipran 200 mg and amitriptyline 150 mg but better tolerance with milnacipran . In order to compare the therapeutic activity of the three doses of milnacipran ( 50 mg/d , 100 mg/d , and 200 mg/d ) we used the responses to amitriptyline as a reference against which to compare the 3 doses of the new drug using analysis of variance on the adjusted data . This approach reveals milnacipran 200 mg is more effective than milnacipran 50 and 100 mg and is the only dose which shows efficacy at least equivalent to that of amitriptyline 150 mg . The dose/efficacy relationship was linear",
"BACKGROUND Milnacipran is a dual-action antidepressant which inhibits both serotonin and noradrenaline reuptake with no affinity for any neurotransmitter receptor studied . METHODS A 6-week double-blind multicentre study compared milnacipran ( 100 mg/day ) with paroxetine ( 20 mg/day ) in 300 out patients with major depression . Efficacy was evaluated using HAMD17 , MADRS and CGI for severity of illness and global improvement . Data were analysed on an intention to treat , last observation carried forward , basis . RESULTS Milnacipran and paroxetine were both effective and well tolerated with no significant difference in their effects . After treatment discontinuation , milnacipran was associated with significantly less emergent symptoms . Responders , at endpoint , to milnacipran had significantly greater levels of psychomotor retardation at baseline than non-responders . LIMITATIONS The study did not include a placebo group so that it is impossible to determine absolute levels of efficacy . CONCLUSIONS Both milnacipran and paroxetine were effective and well tolerated by out patients with major depression treated for 6 weeks . After treatment discontinuation milnacipran was associated with less emergent symptoms . Psychomotor retardation at baseline may be a predictive factor of a favourable response to milnacipran",
"The antidepressant efficacy and tolerability of milnacipran , a dual action serotonin-noradrenaline reuptake inhibitor , were compared with those of the selective serotonin reuptake inhibitor , fluvoxamine , in 113 patients with moderate to severe major depression . Treatment with milnacipran , 50 mg b.d . for 6 weeks , produced a significantly greater reduction in Montgomery-Asberg Depression Rating Scale ( MADRS ) scores than fluvoxamine , 100 mg b.d . ( P = 0.007 ; 65.4 % versus 49.9 % , respectively ) ; significantly greater decreases were also seen on days 7 ( P = 0.04 ) and 28 ( P = 0.03 ) . The response rate ( the proportion of patients showing a decrease in MADRS scores of at least 50 % ) was 78.9 % in patients receiving milnacipran , compared with 60.7 % in fluvoxamine-treated patients ( P = 0.04 ) . Milnacipran also produced greater improvements in 24-item Hamilton Depression Rating Scale scores ( P = 0.05 ) . On the Clinical Global Impression Improvement scale , 77.2 % of milnacipran-treated patients were rated as considerably or markedly improved , compared with 60.7 % of patients receiving fluvoxamine ( P = 0.06 chi-squared ) . Both treatments were well tolerated ; the only significant difference between the two groups was a higher incidence of tremor and drowsiness in patients treated with fluvoxamine . It is concluded that milnacipran may offer some advantages over selective serotonin reuptake inhibitors , such as fluvoxamine , in the treatment of moderate to severe major depression",
"Mixed treatment comparison ( MTC ) meta- analysis is a generalization of st and ard pairwise meta- analysis for A vs B trials , to data structures that include , for example , A vs B , B vs C , and A vs C trials . There are two roles for MTC : one is to strengthen inference concerning the relative efficacy of two treatments , by including both ' direct ' and ' indirect ' comparisons . The other is to facilitate simultaneous inference regarding all treatments , in order for example to select the best treatment . In this paper , we present a range of Bayesian hierarchical models using the Markov chain Monte Carlo software WinBUGS . These are multivariate r and om effects models that allow for variation in true treatment effects across trials . We consider models where the between-trials variance is homogeneous across treatment comparisons as well as heterogeneous variance models . We also compare models with fixed ( unconstrained ) baseline study effects with models with r and om baselines drawn from a common distribution . These models are applied to an illustrative data set and posterior parameter distributions are compared . We discuss model critique and model selection , illustrating the role of Bayesian deviance analysis , and node-based model criticism . The assumptions underlying the MTC models and their parameterization are also discussed",
"SUMMARY The antidepressant efficacy and safety of milnacipran , a dual action antidepressant drug which inhibits the reuptake of serotonin and noradrenaline , was compared with that of the tricyclic antidepressant , imipramine , in a multi-centre , double-blind , r and omised , parallel group , comparative trial in 5 hospital centres in Spain . One hundred patients hospitalised with a diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of the American Psychiatry Association ( third revision ) , with a minimum score of 25 on the Montgomery and Åsberg Depression Rating Scale were treated for 6 weeks with milnacipran ( 100 mg/day ) or imipramine ( 150 mg/day ) . Both treatments showed similar efficacy in reducing depressive symptoms . The frequency of most adverse events in the milnacipran-treated patients was lower than that observed in the imipramine group , particularly those related to anticholinergic symptoms . Dysuria and shivering , however , were more common with milnacipran . The results of this study support others which have demonstrated that milnacipran has equivalent efficacy but superior tolerability to a tricyclic antidepressant such as imipramine",
"CONTEXT Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected , but direct evidence of such bias is currently limited to case reports . OBJECTIVE To study empirically the extent and nature of outcome reporting bias in a cohort of r and omized trials . DESIGN Cohort study using protocol s and published reports of r and omized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg , Denmark , in 1994 - 1995 . The number and characteristics of reported and unreported trial outcomes were recorded from protocol s , journal articles , and a survey of trialists . An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta- analysis . Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias . Protocol s and published articles were also compared to identify discrepancies in primary outcomes . MAIN OUTCOME MEASURES Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes ; consistency between primary outcomes defined in the most recent protocol s and those defined in published articles . RESULTS One hundred two trials with 122 published journal articles and 3736 outcomes were identified . Overall , 50 % of efficacy and 65 % of harm outcomes per trial were incompletely reported . Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy ( pooled odds ratio , 2.4 ; 95 % confidence interval [ CI ] , 1.4 - 4.0 ) and harm ( pooled odds ratio , 4.7 ; 95 % CI , 1.8 - 12.0 ) data . In comparing published articles with protocol s , 62 % of trials had at least 1 primary outcome that was changed , introduced , or omitted . Eighty-six percent of survey responders ( 42/49 ) denied the existence of unreported outcomes despite clear evidence to the contrary . CONCLUSIONS The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocol s. Published articles , as well as review s that incorporate them , may therefore be unreliable and overestimate the benefits of an intervention . To ensure transparency , planned trials should be registered and protocol s should be made publicly available prior to trial completion",
" Fifty-eight in patients with a DSM-III diagnosis of major depressive disorder participated in a 5-week double-blind trial of milnacipran and placebo . Milnacipran was superior to placebo on all measures of depression . The first index of milnacipran superiority was the difference of dropouts due to treatment failure between milnacipran ( 10.3 % ) and placebo ( 55.2 % ) . All patients were evaluated up to day 14 . The improvement with milnacipran was statistically significant at day 14 . Side effects were identical for milnacipran and placebo",
"A multicenter study compared the antidepressant efficacy and the tolerance of two doses of milnacipran ( 50 mg and 100 mg/day ) and amitriptyline ( 150 mg/day ) in three parallel groups of 45 major depressive in patients defined by Research Diagnostic Criteria . After a wash-out period of 4–7 days on placebo with lorazepam and /or nitrazepam if necessary , patients were r and omly assigned to a daily dose of milnacipran 50 mg , milnacipran 100 mg or amitriptyline 150 mg reached on the 5th day and then stable over a 4-week period , with weekly assessment s by means of the Montgomery and Asberg depression scale , the Hamilton depression scale , the Clinical Global Impressions ( CGI ) and the Target Emergent Signs and Symptoms . Results showed significant superiority of both milnacipran 100 mg/day and amitriptyline over milnacipran 50 mg/day at the end of the treatment period . However , amitriptyline induced a nonsignificant trend toward more rapid improvement after 2 weeks of treatment , mainly based on items related to insomnia , supporting more sedative properties of amitriptyline as compared to milnacipran . Anticholinergic side-effects were significantly lower with milnacipran than with amitriptyline , explaining why milnacipran 100 mg exhibited at the end of the treatment period , a nonsignificantly better efficacy index on the CGI . Moreover , in contrast to milnacipran , amitriptyline was responsible for a significant decrease in blood pressure and a significant weight gain",
"This multicentre , double-blind , r and omised trial in 109 patients compared the efficacy and tolerance of the novel selective serotonin and noradrenaline reuptake inhibitor ( SNRI ) antidepressant milnacipran ( 50 mg twice daily , n=53 ) with the established tricyclic agent imipramine ( 75 mg twice daily , n=56 ) over a period of 6 weeks , in patients with major depression ( Montgomery-Asberg depression rating score ( MADRS ) > or = 25 ) . Initiation of antidepressant medication was conducted during a 2-week period of hospitalisation , after a 3- to 7-day washout period . Concomitant psychiatric medication was limited to lorazepam , cyamemazine , chloral hydrate and long-term uncomplicated lithium therapy . Assessment for efficacy using the MADRS and Hamilton rating scales of depression , a visual analogue scale and global evaluation revealed both agents to be highly effective ( P=0.0001 ) in this group of patients . Milnacipran was found to be of similar efficacy to imipramine . Tolerance , assessed by physiological and biochemical examinations with routine inventory and spontaneous report of adverse events , revealed a clear advantage for milnacipran . The incidence of anticholinergic events with milnacipran was about half that with imipramine and the overall incidence of adverse events by either reporting method was markedly lower with milnacipran than with imipramine . Furthermore , the patient drop-out rate with imipramine was double that experienced with milnacipran . Milnacipran appears to possess equal antidepressant efficacy to imipramine but with markedly superior tolerance . Therefore , milnacipran constitutes an important new treatment option in major depression",
"OBJECTIVE Financial conflict of interest has been reported to be prevalent in clinical trials in general medicine and associated with a greater likelihood of reporting results favorable to the intervention being studied . The extent and implication s of industry sponsorship and financial conflict of interest in psychiatric clinical trials have not been investigated , to the authors ' knowledge . METHOD The authors examined funding source and author financial conflict of interest in all clinical trials published in the American Journal of Psychiatry , the Archives of General Psychiatry , the Journal of Clinical Psychopharmacology , and the Journal of Clinical Psychiatry between 2001 and 2003 . RESULTS Among 397 clinical trials identified , 239 ( 60 % ) reported receiving funding from a pharmaceutical company or other interested party , and 187 studies ( 47 % ) included at least one author with a reported financial conflict of interest . Among the 162 r and omized , double-blind , placebo-controlled studies examined , those that reported conflict of interest were 4.9 times more likely to report positive results ; this association was significant only among the subset of pharmaceutical industry-funded studies . CONCLUSIONS Author conflict of interest appears to be prevalent among psychiatric clinical trials and to be associated with a greater likelihood of reporting a drug to be superior to placebo",
"BACKGROUND Conflicting reports exist in the medical literature regarding the association between industry funding and published research findings . In this study , we examine the association between industry funding and the statistical significance of results in recently published medical and surgical trials . METHODS We examined a consecutive series of 332 r and omized trials published between January 1999 and June 2001 in 8 leading surgical journals and 5 medical journals . Each eligible study was independently review ed for method ological quality using a 21-point index with 5 domains : r and omization , outcomes , eligibility criteria , interventions and statistical issues . Our primary analysis included studies that explicitly identified the primary outcome and reported it as statistically significant . For studies that did not explicitly identify a primary outcome , we defined a \" positive \" study as one with at least 1 statistically significant outcome measure . We used multivariable regression analysis to determine whether there was an association between reported industry funding and trial results , while controlling for study quality and sample size . RESULTS Among the 332 r and omized trials , there were 158 drug trials , 87 surgical trials and 87 trials of other therapies . In 122 ( 37 % ) of the trials , authors declared industry funding . An unadjusted analysis of this sample of trials revealed that industry funding was associated with a statistically significant result in favour of the new industry product ( odds ratio [ OR ] 1.9 , 95 % confidence interval [ CI ] 1.3 - 3.5 ) . The association remained significant after adjustment for study quality and sample size ( adjusted OR 1.8 , 95 % CI 1.1 - 3.0 ) . There was a nonsignificant difference between surgical trials ( OR 8.0 , 95 % CI 1.1 - 53.2 ) and drug trials ( OR 1.6 , 95 % CI 1.1 - 2.8 ) , both of which were likely to have a pro-industry result ( relative OR 5.0 , 95 % CI 0.7 - 37.5 , p = 0.14 ) . INTERPRETATION Industry-funded trials are more likely to be associated with statistically significant pro-industry findings , both in medical trials and surgical interventions",
"Brain-derived neurotrophic factor ( BDNF ) is an important member of the neurotrophin family of growth factors , abundant in the brain and periphery . Research ers have reported that serum BDNF levels in drug-free depressed patients are lower than those of healthy controls , and have proposed that these low levels might reflect a failure of neuronal plasticity in depression . In the present study , we investigated the effects of paroxetine , an SSRI , and milnacipran , an SNRI , on serum BDNF levels in depressed patients . Serum levels of BDNF were measured by ELISA before , 4 weeks , and 8 weeks after the start of treatment with antidepressants . Forty-two patients were r and omly administered paroxetine ( 21 cases ) or milnacipran ( 21 cases ) . A negative correlation was found between serum BDNF levels and baseline Ham-D scores . The response and remission rates for each drug were not significantly different . Serum BDNF levels in responders were significantly increased 2.6- and 1.8-fold 8 weeks after treatment with paroxetine or milnacipran , respectively . These results suggest that both drugs improve the depressive state by increasing BDNF levels",
"We compared the antidepressant efficacy and patient tolerance of two different doses of milnacipran ( 75 mg and 150 mg daily ) in 66 out patients with major depression , using the 17-item Hamilton Depression Rating Scale ( HDRS ) . Only new patients who had never experienced frank depressive episodes before , or those who had remained free from thymoregulators for more than 1 year without recurrence of depressive symptoms , were recruited . Subjects were r and omly selected to receive a daily dose of milnacipran that reached either 75 mg or 150 mg within 2–3 weeks and then remained stable over an 8-week period . The results showed a significant superiority of milnacipran at 150 mg/day over 75 mg/day at the end of the study period in both response ( 50 % or more decrease in total score from baseline , P=0.026 ) and remission ( total HDRS score lower than 7 points , P=0.034 ) . A response was recorded for 56.0 % of the patients treated with 75 mg of milnacipran and for 84.6 % of those treated with 150 mg after the 8-week study period . No significant difference was seen between the treatment groups for either individual or total incidence of adverse events . Notably , nausea and vomiting occurred most often immediately after the first visit , when subjects in both groups started with a daily dose of 50 mg . We conclude that additional comparisons between different doses of milnacipran should be performed to confirm or deny the linear dose/efficacy relationship observed in the present study",
"A multicenter controlled study was design ed to test the hypothesis that a loading dose of an antidepressant could shorten the latency of its clinical efficacy . Three parallel groups of about 40 endogenous depressive in patients received either a loading dose of milnacipran ( 300 mg daily for 2 weeks and 150 mg daily during the 2 following weeks ) , the st and ard regimen of milnacipran in severe depression ( 200 mg daily for 4 weeks ) , or fluvoxamine ( 200 mg daily for 4 weeks ) . The duration of the study was 4 weeks , with assessment s at baseline and after 4 , 9 , 14 , 21 , and 28 days of therapy by means of Montgomery and Asberg depression scale ( MADS ) , the Hamilton depression scale , the Clinical Global Impressions ( CGI ) , and a checklist of symptoms and side-effects . Results showed very similar evolution in the 3 treatment groups . In addition , the level of side-effects did not exhibit significant differences among the treatment groups , except for excitement-nervousness and akathisia which were more frequently reported with fluvoxamine . These results do not support the usefulness of a loading dose of an antidepressant such as milnacipran . They demonstrate however that milnacipran can be given at a 300 mg daily dose from the very first day of treatment with an excellent tolerance",
"This double-blind , r and omised , multicentre study compared the antidepressant efficacy and safety of two doses of milnacipran ( 100 mg/day and 200 mg/day ) and fluoxetine ( 20 mg/day ) in 289 in patients with endogenous depression . After a placebo washout period of 4–7 days , assessment s were performed weekly during ; the first 4 weeks , and then after 6 , 8 and 12 weeks , using the 17-itein Hamilton Depression Rating Scale ( HDRS ) . the Montgomery - Åsberg Depression Rating Scale ( MADRS ) and the Clinical Global Impression ( CGI ) . HDRS total score was reduced by a mean of 14.8 in the milnacipran 100 mg/day group , 12.9 in the milnacipran 200 mg/day group and 12.1 in the fluoxetine 20 mg/day group . MADRS total score decreased by 17.4 , 15.8 and 14.6 , respectively . No significant difference could be shown between the three treatment groups for either the HDRS or MADRS total scores . However , the time-by-time change showed a trend in favour of milnacipran 100 mg/day , which was found significantly superior to fluoxetine at day 28 for several converging parameters ( MADRS , CGI-3 ) . Overall , efficacy ratings for all parameters were highest for milnacipran 100 mg/day , followed by milnacipran 200 mg/day and fluoxetinc 20 mg/day . Side-effect profiles were not significantly different between groups except for a significantly greater frequency of dose-related increase hi heart rate ≥ 100 bpm in milnacipran recipients and a significantly greater weight loss in fluoxetine recipients",
"& NA ; To compare the efficacy and assess the tolerability of milnacipran 50 mg p.o . b.i.d . to placebo in the prevention of recurrence in depressed patients who had responded an acute treatment and had remained in remission during a 4‐month continuation phase . Remission criteria were : a Hamilton Depression Rating Scale ( HDRS ) ( 21‐item ) ≤ 8 , improvement or disappearance of the initial symptoms , and an assessment of ‘ very much improved ’ or ‘ much improved ’ on the Clinical Global Impression ( CGI ) Subscale : Global Improvement . Recurrence was defined by a major depressive episode according to DSM‐III‐R criteria and a minimum score of 18 on the HDRS , with the need to treat the recurrence . The primary analysis was the rate of recurrence as a function of time in the intent‐to‐treat population . Groups were compared using the Cox model . Absolute recurrence rates were 16.3 % ( 17/104 ) in milnacipran‐treated patients and 23.6 % ( 26/110 ) in placebo‐treated patients , with a significant difference in the reduction of recurrence as a function of time ( Kaplan Meier Survival Analysis analysis , P no difference in tolerability between groups . This study demonstrates that milnacipran is effective with good tolerability in preventing recurrence in major depressive disorder over 1 year in patients with recurrent depression who responded to acute treatment with milnacipran and continued their response for 18 weeks",
"The efficacy and the tolerance of milnacipran ( 100 mg/day ) , a second generation antidepressant which equipotently inhibits both noradrenaline and serotonin reuptake , was compared to fluoxetine ( 20 mg/day ) , a selective serotonin reuptake inhibitor , in two parallel groups of , respectively , 97 and 93 major depressive out patients . The duration of the study was 6 weeks , with assessment s every 2 weeks by means of the Montgomery and Asberg depression scale ( MADRS ) , the Hamilton depression scale , the clinical global impressions ( CGI ) , and a checklist of symptoms and side-effects . Results showed significant superiority of fluoxetine over milnacipran on most rating instruments : MADRS ( P=0.01 ) including five individual items , Hamilton depression scale ( P=0.002 ) including ten individual items , CGI of severity ( P=0.01 ) and therapeutical index ( P=0.002 ) . On visual analogue scales assessing the clinical profile of the compounds , fluoxetine was rated as exhibiting more psychostimulating activity than milnacipran ( P=0.0008 ) . The tolerance of the two antidepressants was very similar , with the exception of symptoms of dizziness which were more frequently reported with milnacipran ( P=0.01 ) . These differences in efficacy favoring fluoxetine could result from the selection of a dose of milnacipran below the optimal therapeutic dose for this type of psychiatric patients or to the administration of the compounds in single daily intakes , whereas milnacipran possesses a plasma elimination half-life of only 7",
"ABSTRACT Object : To compare efficacy and safety of milnacipran and fluoxetine in a population of Korean patients with major depression . Research design and methods : The design was a multi-centre , r and omised , comparative clinical study . Patients with major depression ( DSM‐IV diagnostic criteria ) scoring over 17 points on the 17-item Hamilton Depression Scale ( HAM‐D ) and over 21 points on the Montgomery-Asberg Depression Rating Scale ( MADRS ) were recruited and r and omised to receive milnacipran ( 50 mg/day increasing after 1 week to 100 mg/day ) or fluoxetine ( 20 mg/day ) for 6 weeks . All previous medication was stopped at least 7 days before entry into the study . Patients were evaluated ( HAM‐D , MADRS and clinical global impression scale , CGI ) at baseline and after 1 , 2 , 4 and 6 weeks of treatment . All adverse events which developed during the study period were recorded . Results : 70 patients ( milnacipran 39 ; fluoxetine 31 ) were included in the study . Total score on both HAM‐D , MADRS and CGI decreased significantly in both groups after 1 week and continued to decrease throughout the study . There was no significant difference between the two groups for any measurement at any time point . Both antidepressants were well tolerated . In the milnacipran group , 13 patients reported 28 adverse reactions , and in the fluoxetine group 11 patients reported 18 adverse reactions . Two patients discontinued due to adverse events in the milnacipran group and three in the fluoxetine group . There were no clinical ly significant modifications in vital signs , routine blood laboratory tests , biochemistry or ECG throughout the study . Nausea and headache were the most frequently reported adverse events with milnacipran while digestive disturbances , diarrhoea and insomnia were more common with fluoxetine . Conclusion : Milnacipran , like fluoxetine , was found to be effective and well tolerated for the treatment of major depression in this population of depressed Korean patients . Principal limitations of the study were its open design , its small sample size and its relatively short duration",
"BACKGROUND Duloxetine hydrochloride , a dual reuptake inhibitor of serotonin and norepinephrine , was evaluated for therapeutic efficacy and safety/tolerability in the treatment of major depression . METHOD In an 8-week multicenter , double-blind , placebo-controlled study , 173 patients ( aged 18 - 65 years ) with DSM-IV major depressive disorder were r and omly allocated to receive placebo ( N = 70 ) , duloxetine ( N = 70 ) , or fluoxetine , 20 mg q.d . ( N = 33 ) . Duloxetine dose was titrated in the first 3 weeks in a forced-titration regimen from 40 mg ( 20 mg b.i.d . ) to 120 mg/day ( 60 mg b.i.d . ) . Patients were required to have a Clinical Global Impressions (CGI)-Severity of Illness scale score of at least moderate severity ( > or = 4 ) and a 17-item Hamilton Rating Scale for Depression ( HAM-D-17 ) total score of at least 15 . Patients could not have had any current primary DSM-IV Axis I diagnosis other than major depressive disorder , or any anxiety disorder as a primary diagnosis within the past year , excluding specific phobias . The primary efficacy measurement was the HAM-D-17 total score , and secondary measures included the Montgomery-Asberg Depression Rating Scale , CGI-Severity of Illness and CGI-Improvement , and Patient Global Impression of Improvement . Safety was evaluated by recording the occurrence of discontinuation rates and treatment-emergent adverse events and by measurement of vital signs and laboratory analytes . RESULTS Duloxetine was superior to placebo in change on the HAM-D-17 ( p = .009 ) . Estimated probabilities of response and remission were 64 % and 56 % , respectively , for duloxetine , compared with 52 % and 30 % for fluoxetine and 48 % and 32 % for placebo . Duloxetine was numerically superior to fluoxetine on the primary and most of the secondary outcome measures . In general , duloxetine was well tolerated ; 76 % of patients achieved the maximum dose , and insomnia and asthenia were the only adverse events reported statistically significantly ( p duloxetine-treated patients compared with placebo-treated patients . CONCLUSION These data indicate that duloxetine is efficacious for the treatment of major depressive disorder and is well tolerated and safe",
"Milnacipran is a new antidepressant with similar effects on the reuptake of noradrenaline and serotonin in vivo and in vitro . The present study was design ed to study the efficary and tolerability of long-term treatment of depressed patients with milnacipran in comparison with clomipramine . The study was design ed as a double-blind , r and omized parallel group comparison at 10 different hospitals in The Netherl and s. The duration of treatment was 6 weeks , with an extension period of 20 weeks . The entire study period of 26 weeks was done under double-blind conditions . There was 1 week of dose escalation after which the patients received either treatment with milnacipran 200 mg/day or clomipramine 150 mg/day in fixed doses during weeks 2 to 10 . This was followed by flexible dosing with 200 , 150 , or 100 mg/day milnacipran or 150 , 100 or 75 mg/day clomipramine during weeks 11 to 26 . Both milnacipran and clomipramine showed poor antidepressant activity in this patient sample . There were no significant differences between the two treatment groups with respect to antidepressant efficacy . Several method ological reasons might explain the lack of antidepressant efficacy in the present study . In 45 % of the patients in the present study , the duration of the current episode of depression was longer than 6 months , whereas 48 % of the patients used antidepressants before the study and 73 % of these appeared to be non-responders . This raises the possibility that the present sample consisted of treatment-resistant depressive patients"
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41181198-06ff-11f0-808a-c43d1ab1c353
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The number of available walking tests has increased dramatically over the past decades . Therefore , it is highly important to help clinicians choose the most appropriate walking test for a specific setting . This systematic review aim ed to critically evaluate the reliability , validity , and responsiveness of clinical walking speed in a broad population of elderly persons living in the community , sheltered housing , or institutions . Literature search es were performed in several different data bases . Key words were based on the topic of the measurement properties of performance-based clinical tools for quantifying walking . The instrument selected for review was walking speed . The methods and results of all the evaluated measurement properties were rated by using a st and ard checklist for appraising the qualitative attributes and measurement properties of the instrument . A total number of 3,781 abstract s were review ed , and 86 articles were chosen for inclusion . Habitual walking speed seems to be highly reliable in community-dwelling people and residents in mixed setting s. There have not been any studies that accord with our inclusion and exclusion criteria that have evaluated the reliability of maximum walking speed in an aged population . Walking speed is a highly valid test , both at habitual and maximum speed . Few studies gave information about responsiveness for walking speed , which means that these results can not be evaluated properly . Habitual walking speed is a reliable measure , but maximum walking speed needs further evaluation . Both habitual and maximum walking speeds are valid instruments , and they predict death , hospitalization/institutionalization , and decline in mobility
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"This study examined balance ability , lower-extremity muscle strength , fear of falling and their inter-relationships in 40 community-dwelling older adults ( > 65 years ) . Subjects who self-identified either as being fearful offalling or not ( no concern ) were screened to exclude those with known risk factors for falling . Limits of stability , maximal isometric strength , gait speed , and fear of falling were contrasted between groups ( 27 control subjects , 13 fearful subjects ) . Those fearful of falling demonstrated smaller center of pressure ( COP ) excursions in anterior , left , and right directions ( p used a smaller percentage of their base of support during maximal weight shifting in combined anterior-posterior and right-left directions ( p Strength did not differ between groups , but was associated with the ability to shift the COP in the anterior-posterior direction ( p weight shifting ability ( p Seniors fearful of falling demonstrated limitations in balance ability and balance confidence that could not be explained by muscle weakness",
"The aims of this r and omised controlled trial were to determine if a high-intensity functional exercise program improves balance , gait ability , and lower-limb strength in older persons dependent in activities of daily living and if an intake of protein-enriched energy supplement immediately after the exercises increases the effects of the training . One hundred and ninety-one older persons dependent in activities of daily living , living in residential care facilities , and with a Mini-Mental State Examination ( MMSE ) score of ? 10 participated . They were r and omised to a high-intensity functional exercise program or a control activity , which included 29 sessions over 3 months , as well as to protein-enriched energy supplement or placebo . Berg Balance Scale , self-paced and maximum gait speed , and one-repetition maximum in lower-limb strength were followed-up at three and six months and analysed by 2 x 2 factorial ANCOVA , using the intention-to-treat principle . At three months , the exercise group had improved significantly in self-paced gait speed compared with the control group ( mean difference 0.04 m/s , p = 0.02 ) . At six months , there were significant improvements favouring the exercise group for Berg Balance Scale ( 1.9 points , p = 0.05 ) , self-paced gait speed ( 0.05 m/s , p = 0.009 ) , and lower-limb strength ( 10.8 kg , p = 0.03 ) . No interaction effects were seen between the exercise and nutrition interventions . In conclusion , a high-intensity functional exercise program has positive long-term effects in balance , gait ability , and lower-limb strength for older persons dependent in activities of daily living . An intake of protein-enriched energy supplement immediately after the exercises does not appear to increase the effects of the training",
"Studies of test-retest reliability for health-related quality of life instruments have used varying intervals between test administrations . There is no evidence available to aid in the selection of the time interval between question naire administrations for a study of test-retest reliability for health status instruments . We compared the test-retest reliability at 2 days and 2 weeks for four knee-rating scales and the eight domains of the SF-36 . Seventy patients with disorders of the knee who were in a stable state were r and omly allocated to repeat the question naires at either 2 days or 2 weeks . There were no statistically significant differences in the test-retest reliability ( intraclass correlation coefficient and limits of agreement statistics ) for the two time intervals",
"BACKGROUND AND PURPOSE The interpretation of patient scores on clinical tests of physical mobility is limited by a lack of data describing the range of performance among people without disabilities . The purpose of this study was to provide data for 4 common clinical tests in a sample of community-dwelling older adults . SUBJECTS Ninety-six community-dwelling elderly people ( 61 - 89 years of age ) with independent functioning performed 4 clinical tests . METHODS Data were collected on the Six-Minute Walk Test ( 6MW ) , Berg Balance Scale ( BBS ) , and Timed Up & Go Test ( TUG ) and during comfortable- and fast-speed walking ( CGS and FGS ) . Intraclass correlation coefficients ( ICCs ) were used to determine the test-retest reliability for the 6MW , TUG , CGS , and FGS measurements . Data were analyzed by gender and age ( 60 - 69 , 70 - 79 , and 80 - 89 years ) cohorts , similar to previous studies . Means , st and ard deviations , and 95 % confidence intervals for each measurement were calculated for each cohort . RESULTS The 6MW , TUG , CGS , and FGS measurements showed high test-retest reliability ( ICC [2,1]=.95-.97 ) . Mean test scores showed a trend of age-related declines for the 6MW , BBS , TUG , CGS , and FGS for both male and female subjects . DISCUSSION AND CONCLUSION Preliminary descriptive data suggest that physical therapists should use age-related data when interpreting patient data obtained for the 6MW , BBS , TUG , CGS and FGS . Further data on these clinical tests with larger sample sizes are needed to serve as a reference for patient comparisons",
"Work Package 3 of the Prevention of Falls Network Europe has evaluated measurement properties of clinical balance measures to be used to : ( 1 ) select participants for interventions with the goal to prevent falls in older people , and ( 2 ) assess the results of such intervention on balance function . Inclusion in a fall prevention study may be based on measures identifying subjects who have impaired balance or increased risk of future falls . We propose that an appropriate statistical method to analyse discriminative ability of a balance measure is discriminant analysis or logistic regression analysis . The optimal cut-off score is best determined by plotting a receiver-operating-characteristic curve for different cut-off values . The evaluation of predictors for risk of future falls should be based on a study design with a prospect i ve data collection of falls . Sensitivity to change is a measurement property needed to evaluate the outcome of an intervention . The st and ardized response mean is frequently encountered in the literature and is recommended as a statistical measure of sensitivity to change in the context of an intervention study . Adequate reliability is a prerequisite for consistent measurement . Relative reliability may be reported as an intraclass correlation coefficient and absolute reliability as the within-subject st and ard deviation ( s(w ) ) , also called st and ard error of measurement . When measurement error is proportional to the score , calculation of a coefficient of variation can be considered . In a second paper , the authors will evaluate clinical balance measures for use in fall prevention studies based upon criteria recommended in this report",
"BACKGROUND The reproducibility of a performance-based and a self-reported measure of functional status was investigated , as well as the impact of age and cognitive function on the reproducibility . METHODS Of a r and om sample of 114 men of the 1995 survey of the Zutphen Elderly Study , 105 men ( aged 79.9 + /- 4.5 years ) participated in a test-retest study . They filled out a question naire on disabilities and carried out performance tests twice , in a 2-week interval . Four performance tests were administered ( st and ing balance , walking speed , chair st and , and external shoulder rotation ) , and a summary performance score was constructed . The number of self-reported disabilities in basic activities of daily living , mobility , and instrumental activities of daily living were assessed . Kappa statistics and Pearson correlation coefficients between test and retest measurements were computed for the total group and stratified by age and cognitive function . RESULTS Three performance tests and the summary performance score had fair to good reproducibility ( walking speed : Pearsons r = .90 , chair st and : r = .82 , shoulder rotation : kappa = .49 , summary score : kappa = .52 ) . Only the test for st and ing balance was poorly reproducible ( kappa = .29 ) . The self-reported functional status was fairly to good reproducible ( kappa = .63 , r = .87 ) . Self-reported functional status was significantly less reproducible in very old and cognitively impaired than in younger and nonimpaired individuals . CONCLUSIONS In the elderly male subjects , performance tests and self-reported disabilities had moderate to good reproducibility , with the exception of the test for st and ing balance . In very old or cognitively impaired population s , self-reported functional status may have a lower reproducibility",
"Study objective : To compare health walks , a community based lay-led walking scheme versus advice only on physical activity and cardiovascular health status in middle aged adults . Design : R and omised controlled trial with one year follow up . Physical activity was measured by question naire . Other measures included attitudes to exercise , body mass index , cholesterol , aerobic capacity , and blood pressure . Setting : Primary care and community . Participants : 260 men and women aged 40–70 years , taking less than 120 minutes of moderate intensity activity per week . Main results : Seventy three per cent of people completed the trial . Of these , the proportion increasing their activity above 120 minutes of moderate intensity activity per week was 22.6 % in the advice only and 35.7 % in the health walks group at 12 months ( between group difference = 13 % ( 95 % CI 0.003 % to 25.9 % ) p=0.05 ) . Intention to treat analysis , using the last known value for missing cases , demonstrated smaller differences between the groups ( between group difference = 6 % ( 95 % CI −5 % to 16.4 % ) ) with the trend in favour of health walks . There were improvements in the total time spent and number of occasions of moderate intensity activity , and aerobic capacity , but no statistically significant differences between the groups . Other cardiovascular risk factors remained unchanged . Conclusions : There were no significant between group differences in self reported physical activity at 12 month follow up when the analysis was by intention to treat . In people who completed the trial , health walks was more effective than giving advice only in increasing moderate intensity activity above 120 minutes per week ",
"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",
"OBJECTIVE To identify reasons for dropout and factors that may predict dropout from an exercise intervention aim ed at improving physical function in frail older persons . DESIGN / SETTING An 18-month r and omized controlled intervention in a community setting . The intervention comprised 2 groups : class-based and self-paced exercise . PARTICIPANTS 155 community-dwelling older persons , mean age 77.4 , with mildly to moderately compromised mobility . MEASUREMENTS The primary outcome measure was dropout . Dropouts were grouped as : D0 , dropout between baseline and 3-month assessment , and D3 , dropout after 3-month assessment . MEASUREMENTS Measurements of demographics , health , and physical performance included self-rated health , SF-36 , disease burden , adverse events , PPT-8 , MacArthur battery , 6-minute walk , and gait velocity . RESULTS There were 56 dropouts ( 36 % ) , 31 in first 3 months . Compared with retained subjects ( R ) , the D0 group had greater disease burden ( P = .011 ) , worse self-perceived physical health ( P = .014 ) , slower usual gait speed ( P = .001 ) , and walked a shorter distance over 6 minutes ( P 6-minute walk ( P usual gait velocity ( P walk distance were the strongest independent predictors of dropout , and self-paced exercise assignment increased the risk of dropout . CONCLUSIONS We observed baseline differences between early dropouts and retained subjects in disease burden , physical function , and endurance , suggesting that these factors at baseline may predict dropout . Improved underst and ing of factors that lead to and predict dropout could allow research ers to identify subjects at risk of dropout before r and omization . Assigning targeted retention techniques in accordance with these factors could result in decreased attrition in future studies . Therefore , the results of selective attrition of frailer subjects , such as decreased heterogeneity , restricted generalizability of study findings , and limited underst and ing of exercise effects in this population , would be avoided",
"OBJECTIVES To estimate the relationship between 1-year improvement in measures of health and physical function and 8-year survival . DESIGN Prospect i ve cohort study . SETTING Medicare health maintenance organization and Veterans Affairs primary care programs . PARTICIPANTS Persons aged 65 and older ( N=439 ) . MEASUREMENTS Six measures of health and function assessed at baseline and quarterly over 1 year . Participants were classified as improved at 1 year , transiently improved , or never improved for each measure using a priori definitions of meaningful change : gait speed ( usual walking pace over 4 m ) , 0.1 m/s ; Short Physical Performance Battery , 1 point ; Medical Outcomes Study 36-item Short Form Health Survey physical function , 10 points ; EuroQol , 0.1 point ; National Health Interview activity of daily living scale , 2 points ; and global health change , two levels or reaching the ceiling . Mortality was ascertained from the National Death Index . Covariates included demographics , comorbidity , cognitive function , and hospitalization . RESULTS Of the six measures , only improved gait speed was associated with survival . Mortality after 8 years was 31.6 % , 41.2 % , and 49.3 % for those with improved , transiently improved , and never improved gait speed , respectively . The survival benefit for improvement at 1 year persisted after adjustment for covariates ( hazard ratio=0.42 , 95 % confidence interval=0.29 - 0.61 , P reduction in mortality . Because gait speed is easily measured , clinical ly interpretable , and potentially modifiable , it may be a useful \" vital sign \" for older adults . Further research is needed to determine whether interventions to improve gait speed affect survival",
"OBJECTIVES To measure the prevalence of fear of falling in older adults at the time of long- term care ( LTC ) enrollment and identify potentially treatable risk factors for low fall related self-efficacy . DESIGN Prospect i ve cohort study . SETTING Three LTC programs in Upstate New York . PARTICIPANTS 112 new enrollees in LTC , aged 55 or older , who passed a cognitive screen . MEASUREMENTS Self-reported falls , the falls efficacy scale ( FES ) , medical conditions , the short geriatric depression scale , and physical performance measures ( Berg balance scale , hip flexor , knee extensor and grip strength , gait speed and a six-minute walk ) . RESULTS Of the 54 subjects ( 48.2 % ) who reported fear of falling , 41 ( 75.9 % ) reported activity modification secondary to fear . Fearful subjects were more likely to be female ( P = .003 ) , report low back pain ( P = .030 ) and lower extremity arthritis ( P = .037 ) . Fearful subjects were weaker at the hip ( P knee ( P = .001 ) , and had shorter six-minute walk distances . Subjects with better FES scores had better Berg scores ( P greater hip and knee strength , had faster gait speeds and walked further in six minutes ( P FES scores and fearful subjects were more likely to have depressive symptoms ( P = .003 , P = .044 , respectively ) . CONCLUSION Falls and fear of falling are more common in new LTC enrollees than in previously described community dwelling and SNF cohorts . Attention to associated characteristics like depression , arthritis , low back pain and lower extremity weakness may identify opportunities to reduce fear and improve patient safety during this transitional period",
"Purpose : Mobility limitations and cognitive disorders have often been observed as risks for institutionalization . However , their combined effects on risk of institutionalization among initially community-dwelling older people have been less well reported . Design : A prospect i ve cohort study with 10-year surveillance on institutionalization . Subjects : Study population ( n = 476 ) consisted of 75- and 80-year-old people who were community-dwelling , had not been diagnosed with dementia , and participated in tests on walking speed and cognitive capacity at a research centre . Measures : Cognitive capacity was measured with three vali date d psychometric tests that were from the Wechsler Adult Intelligence Scale , Wechsler Memory Scale and Schaie- Thurstone Adult Mental Abilities Test . Mobility was measured with walking speed over a 10-m distance . Exclusive distribution based study groups were formed with cut-offs at the lowest third as follows : no limitation , solely mobility limitation , solely cognitive deficits , and combined mobility limitation and cognitive deficits . Cox proportional hazards model was used to determine the relative risks of institutionalization for the study groups . Results : Eleven percent of the participants were institutionalized during the 10-year surveillance . The risk for institutionalization was 4.9 times greater ( 95 % confidence interval : 2.1–11.2 ) for those who had co-existing mobility limitations and cognitive deficits than for those with no limitations . Conclusions : The findings show that the accumulation of limitations in physical and cognitive performance substantially decreases the possibility for a person remaining at home . This might be due to a decreased reserve capacity and ineffective compensatory strategies . Therefore , interventions targeted to improve even one limitation , or prevent accumulation of these risk factors , could significantly reduce the risk of institutionalization",
"OBJECTIVES To define clinical ly relevant cutpoints for usual gait speed and to investigate their predictive value for health-related events in older persons . DESIGN Prospect i ve cohort study . SETTING Health , Aging and Body Composition Study . PARTICIPANTS Three thous and forty-seven well-functioning older persons ( mean age 74.2 ) . MEASUREMENTS Usual gait speed on a 6-m course was assessed at baseline . Participants were r and omly divided into two groups to identify ( Sample A ; n=2,031 ) and then vali date ( Sample B ; n=1,016 ) usual gait-speed cutpoints . Rates of persistent lower extremity limitation events ( mean follow-up 4.9 years ) were calculated according to gait speed in Sample A. A cutpoint ( defining high- ( or = 1 m/s ) groups ) was identified based on persistent lower extremity limitation events . The predictive value of the identified cutpoints for major health-related events ( persistent severe lower extremity limitation , death , and hospitalization ) was evaluated in Sample B using Cox regression analyses . RESULTS A grade d response was seen between risk groups and health-related outcomes . Participants in the high-risk group had a higher risk of persistent lower extremity limitation ( rate ratio (RR)=2.20 , 95 % confidence interval (CI)=1.76 - 2.74 ) , persistent severe lower extremity limitation ( RR=2.29 , 95 % CI=1.63 - 3.20 ) , death ( RR=1.64 , 95 % CI=1.14 - 2.37 ) , and hospitalization ( RR=1.48 , 95 % CI=1.02 - 2.13 ) than those in the low-risk group . CONCLUSION Usual gait speed of less than 1 m/s identifies persons at high risk of health-related outcomes in well-functioning older people . Provision of a clinical ly meaningful cutpoint for usual gait speed may facilitate its use in clinical and research setting",
"OBJECTIVE To see if there is a relationship between clinical and laboratory tests of balance , muscular strength and gait in elderly women . DESIGN A r and omized population -based study . SETTING S Malmö , Sweden . METHODS We investigated balance with a simple test of st and ing on one leg , as well as a computerized balance platform . Muscular strength was tested by computerized dynamometer . Extension and flexion of the knee and dorsiflexion of the ankle were tested . We measured the time and number of steps taken to walk a certain distance and the subjects ' height and weight . PARTICIPANTS 418 r and omly selected 75-year-old women , of whom 230 took part . RESULTS There was no relation between the computerized balance tests and any of the other tests . The non-computerized balance test was correlated with gait time and number of steps ( r = -0.50 , P Tests of extension and flexion , strength of the knee and ankle dorsiflexion were related to gait , speed and number of steps . Heavy women had poorer balance when assessed by the non-computerized test ( r = -0.32 , P computerized , stable platform , eyes-open test ( r = 0.27 , P eyes-closed test ( r = 0.44 , P computerized platform tests . Muscle strength of the leg is not necessarily linked to balance , but rather to gait performance",
"BACKGROUND Although lower and upper extremity performance measures are widely used and represent vali date d physical function measures in older adults , there is limited information regarding the magnitude of changes in these measures over time . This study ( i ) assesses prospect i ve changes in physical performance measures , ( ii ) defines a summary score that demonstrates a significant amount of change over time , and ( iii ) examines rates of decline according to age and baseline performance levels . METHODS Data from the Women 's Health and Aging Study ( WHAS ) were analyzed to assess change in the one third most disabled older women living in the community . Lower extremity function was assessed using walking speed , balance , and chair st and s tests . The putting-on-blouse test , the lock and key test , the Purdue Pegboard test , and grip strength were used to gauge upper extremity function . Continuous and categorical summary performance scores were calculated using continuous and categorical data of lower and upper performance measures . RESULTS After 3 years , lower extremity performance measures declined by 16%-27 % , while upper extremity performance measures declined less ( 7%-24 % ) . For lower extremity function , the continuous summary performance score showed a slightly greater 3-year decline from baseline ( decline vs baseline mean : 23 % ; decline vs SD of the baseline mean : 59 % ) than the categorical score ( 22 % and 41 % , respectively ) . Older age and intermediate level of baseline performance were associated with the greatest decline , especially for lower extremity function . CONCLUSIONS In moderately to severely disabled women aged 65 or older , lower extremity measures show more change over 3 years than upper extremity measures . Among the lower extremity summary scores , the continuous score changes more over time than the categorical score with respect to the baseline SD . The lower extremity continuous summary performance score may be a useful outcome measure for clinical studies of physical performance in older women",
"Abstract Objective The criteria for inappropriate drug use developed by Beers have been widely used in drug utilization review s to assess the quality of prescribing , but there is still inconclusive evidence that these criteria can impact on patient outcomes . The aim of the present study was to evaluate the relationship between the use of inappropriate drugs and measures of physical performance , muscle strength and functional status in an elderly population ( 80 + years ) . Methods Data are from the baseline evaluation of 364 subjects enrolled in the ilSIRENTE study , a prospect i ve cohort study performed in a mountain community living in the Sirente geographic area ( L’Aquila , Abruzzo ) in Central Italy . Physical performance was assessed using the physical performance battery score ( SPPB ) , which is based on three timed tests : 4-m walking speed , balance and chair st and tests . Muscle strength was measured by h and grip strength . Inappropriate drug use was defined by the 2003 Beers criteria . Analyses of covariance were performed to evaluate the relationship of inappropriate drugs with physical function . Results In the unadjusted model , all of the physical performance , muscle strength and functional measures showed significant associations with inappropriate drug use . Following adjustment for potential confounders , which included age , gender , physical activity level , cognitive performance scale , comorbidity , lung diseases and diabetes , these associations were still statistically significant for the physical performance battery score [ non-users inappropriate drugs : 7.0 ; st and ard error ( SE ) : 0.1 ; users inappropriate drugs : 6.1 ; SE : 0.2 ; p = 0.007 ] The 4-m walking speed , physical performance battery score and Total Activities of Daily Living ( ADL ) scale score showed worsening results among subjects using two inappropriate medications compared with subjects using one inappropriate drug or none at all . Conclusions The use of inappropriate medication ( as defined by Beers 2003 criteria ) was found to be common among the elderly Italian study cohort living in the community . Our results suggest that among old – old subjects the use of inappropriate drugs is associated with impaired physical performance",
"BACKGROUND The purpose of this prospect i ve cohort study was to determine if older individuals at risk for recurrent falls are best identified by mobility or functional assessment s. METHODS Eighty-four community-dwelling , frail male veterans , mean age of 75.5 years ( SD=7.33 ) , participated . The history of recurrent falls was determined by self or proxy report in a clinical interview . Mobility assessment s included the Modified Gait Abnormality Rating Scale ( GARS-M ) , stride length , and walking velocity ; functional performance was determined using the Physical Performance Test ( PPT ) . The clinical usefulness of the measures was described by determining the sensitivity and specificity of each measure using the history of recurrent falls as a st and ard . RESULT Stepwise logistic regression analysis of the data indicated that the GARS-M ( p PPT ( p sensitivity and specificity of the measures used were : GARS-M , 62.3 % and 87.1 % ; PPT , 79.3 % and 71.0 % ; walking speed , 71.7 % and 74.2 % ; and stride length , 63.2 % and 77.4 % . Together the GARS-M and PPT demonstrated the highest sensitivity of 90.6 % and the highest specificity of 87 . 1 % based on a subject testing positive on at least one test . CONCLUSION Used independently and in combination , the GARS-M and the PPT were clinical ly useful measures in screening for older individuals at risk for recurrent falls",
"PURPOSE To compare two self-administered , one interviewer-administered , and one performance-based measure of physical function in community-based older persons . METHODS Eighty-three subjects were recruited from meal sites , senior recreation centers , and senior housing units for a comprehensive geriatric assessment program . At the time of screening , study participants self-administered the Functional Status Question naire ( FSQ ) and were administered the Katz Activities of Daily Living ( ADL ) and the Older Americans Re sources and Services Instrumental Activities of Daily Living ( OARS-IADL ) instruments by interview . Participants also completed the Physical Performance Test ( PPT ) and were given the Medical Outcomes Study SF-36 to self-administer on site or at home and return by mail . RESULTS All 83 subjects completed FSQ , Katz ADL , OARS-IADL , and PPT ; 72 returned SF-36 forms . Correlations between the two self-administered physical function measures ( FSQ and SF-36 ) were higher than between self-administered and interviewer-assessed ( ADL and OARS-IADL ) or performance-based ( PPT ) measures . When assessed for construct validity , the self-administered , OARS , and PPT measures had comparable correlations with role limitations as a result of physical health problems , but relationships between physical functional status measures and other SF-36 measures of health were inconsistent . CONCLUSION The relationships between commonly used self-administered , interviewer-administered , and performance-based measures of physical function were inconsistent and weak , suggesting that these instruments are not measuring the same construct",
"OBJECTIVE To test the clinical relevance of the stair climb power test ( SCPT ) as a measure of leg power impairments in mobility-limited older adults . DESIGN Cross-sectional analysis of baseline data from participants within a r and omized controlled trial . SETTING Rehabilitation research gym . PARTICIPANTS Community-dwelling older adults ( N=138 ; mean age , 75.4 y ) with mobility limitations as defined by the Short Physical Performance Battery ( SPPB ) . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Leg power measures included the SCPT and double leg press power measured at 40 % ( DLP40 ) and 70 % ( DLP70 ) of the 1 repetition maximum . Mobility performance tests included the SPPB and its 3 components : gait speed , chair st and time , and st and ing balance . RESULTS Stair climb power per kilogram ( SCP/kg ) had correlations of moderate strength ( r=.47 , r=.52 ) with DLP40/kg and DLP70/kg , respectively . All 3 leg power measures correlated with each of the mobility performance measures with the exception of DLP40/kg ( r=.11 , P=.27 ) and DLP70/kg ( r=.11 , P=.18 ) with st and ing balance . Magnitudes of association , as described by the Pearson correlation coefficient , did not differ substantively among the separate power measures as they related to SPPB performance overall . Separate adjusted multivariate models evaluating the relationship between leg power and SPPB performance were all statistically significant and described equivalent amounts of the total variance ( R(2 ) ) in SPPB performance ( SCP/kg , R(2)=.30 ; DLP40 , R(2)=.32 ; DLP70 , R(2)=.31 ) . Analyses of the components of the SPPB show that the SCPT had stronger associations than the other leg power impairment measures with models predicting chair st and ( SCP/kg , R(2)=.25 ; DLP40 , R(2)=.12 ; DLP70 , R(2)=.13 ) , whereas both types of leg press power testing had stronger associations with models predicting gait speed ( SCP/kg , R(2)=.16 ; DLP40 , R(2)=.34 ; DLP70 , R(2)=.34 ) . Stair climb power was the only power measure that was a significant component of models predicting st and ing balance ( SCP/kg R(2)=.20 ) . CONCLUSIONS The SCPT is a clinical ly relevant measure of leg power impairments . It is associated with more complex modes of testing leg power impairments and is meaningfully associated with mobility performance , making it suitable for clinical setting s in which impairment-mobility relationships are of interest",
"OBJECTIVES To describe women who attribute new disability to old age and to identify demographic , medical , behavioral , and psychosocial characteristics that correlate with attributing new disability to old age . DESIGN Prospect i ve cohort study with 4-year follow-up . SETTING Four geographic regions of the United States . PARTICIPANTS 9704 women aged > or = 67 years participating in the Study of Osteoporotic Fractures . Of these , 657 who reported no disability at baseline but at follow-up reported difficulty carrying out 1 or more of 13 functional activities were eligible for our analysis . MEASUREMENTS All women reporting difficulty in any functional activity at follow-up were asked \" What is the main condition that causes you to have difficulty or prevents you from ( doing the activity ) ? \" and were shown a card listing 14 medical conditions as well as the option \" old age , \" from which they could choose only one response . Women attributing difficulty or inability in 1 or more functional activities to old age were classified as attributing new disability to old age . We examined the relationship between attributing new disability to old age and the following characteristics measured at baseline : age , level of education , medical comorbidity , cognitive function , body mass index ( BMI ) , gait speed , grip strength , visual acuity , physical activity level , smoking status , social network level , and depressed mood . RESULTS Overall , 13.5 % of women attributed new disability to old age . Age was a strong independent correlate of attributing new disability to old age : compared with women age 67 to 69 , the odds of attributing new disability to old age for women age 70 to 79 was 3.6 times as large ( 95 % confidence interval [ CI ] = 1.6 - 8.3 ) , and for women age 80 or over was 5.5 times as large ( 95 % CI = 2.1 - 14.7 ) . The only other characteristic that remained an independent correlate of attributing new disability to old age was grip strength ; for each decile decrease in grip strength , a woman 's odds of attributing new disability to old age increased by 9 % ( odds ratio [ OR ] = 1.09 , 95 % CI = 1.01 - 1.19 ) . CONCLUSIONS Despite great advances in geriatric medicine , old age is still perceived as a causal agent in functional decline , especially among our oldest patients . Further study is needed to determine whether , how often , and under what circumstances older adults who attribute new disability to old age have medical conditions amenable to interventions that could preserve their functioning and improve their quality of life",
"Increasing evidence from experimental studies and human observations suggests that drugs with anticholinergic properties can cause physical and mental impairment . The aim of this study was to evaluate the relationship between the use of drugs with anticholinergic activity and measures of physical performance , muscle strength , and functional status in persons aged 80 years or older . Data are from baseline evaluation of 364 subjects enrolled in the ilSIRENTE study . The ilSIRENTE study is a prospect i ve cohort study performed in the mountain community living in the Sirente geographic area ( L'Aquila , Abruzzo ) in Central Italy . Physical performance was assessed using the physical performance battery score ( Short Physical Performance Battery ) , which is based on three timed tests : 4‐meter walking speed , balance , and chair st and tests . Muscle strength was measured by h and grip strength . We defined as anticholinergic drugs all medications for which serum anticholinergic activity was previously demonstrated . Analyses of covariance were performed to evaluate the relationship of anticholinergic drugs with physical function . In the unadjusted model , all the physical performance , muscle strength , and functional measures showed significant associations with the anticholinergic drug use . After adjustment for potential confounders ( age , gender , smoking , physical activity level , cognitive performance score , living alone , body mass index , congestive heart failure , lung diseases , diabetes ) , these associations were weaker but still statistically significant ( physical performance battery score : non‐users anticholinergic drugs 6.9 , SE 0.1 , users anticholinergic drugs 6.1 , SE 0.2 , P=0.05 ; h and grip strength : non‐users anticholinergic drugs 31.3 kg , SE 0.8 , users anticholinergic drugs 28.8 kg , SE 1.0 , P=0.05 ; Activities of Daily Living scale score : non‐users anticholinergic drugs 1.2 , SE 0.1 , users anticholinergic drugs 1.6 , SE 0.1 , P=0.03 ; Instrumental Activities of Daily Living scale score : non‐users anticholinergic drugs 2.7 , SE 0.1 , users anticholinergic drugs 3.4 , SE 0.1 , P of medication with anticholinergic properties is common among community older subjects in Italy . Our results suggest that among old‐old subjects the use of anticholinergic drugs is associated with impaired physical performance and functional status",
"Arai T , Obuchi S , Inaba Y , Nagasawa H , Shiba Y , Watanabe S , Kimura K , Kojima M : The effects of short-term exercise intervention on falls self-efficacy and the relationship between changes in physical function and falls self-efficacy in Japanese older people : a r and omized controlled trial . Am J Phys Med Rehabil 2007;86:133–141 . Objective : To evaluate the effects of short-term exercise intervention on falls self-efficacy and to evaluate the relationships between baseline falls self-efficacy and changes in physical function in older people . Design : Single-blinded r and omized controlled trial . The participants were 171 subjects aged 65 and older . They were r and omly assigned into an exercise intervention group or a health education group . The subjects in the exercise intervention group performed an exercise program for 3 mos . Falls self-efficacy was measured using the falls efficacy scale ( FES ) . The measurements of physical function included static and dynamic balance , walking velocity , flexibility , and strength . Results : There was no significant improvement of FES in either group . But there were significant negative correlations between baseline FES score and the change in maximum walking velocity ( r = −0.29 , P and knee extensor strength ( r = −0.25 , P the change in static balance was related to baseline FES . Conclusions : The results suggest that a short-term exercise intervention had no effect , possibly because of the high baseline FES scores of the participants , on the confidence of community-dwelling older persons . However , the negative association between FES score and increases in some measures of function suggest that short-term exercise may be beneficial to a subset of older persons with lower FES scores",
"OBJECTIVE To examine the association between previous fracture and different aspects of physical performance . DESIGN Population -based retrospective study . SETTING Orthopaedic research department . PARTICIPANTS R and omly selected women ( N = 1044 ) , all 75 years old and participants of the Malmö Osteoporosis Prospect i ve Risk Assessment study . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Type of and time since any previous fracture event were compared with results of tests on physical performance function ( Romberg test , computerized sway test , gait speed , question naire ) at the age of 75 . RESULTS Women with no previous fractures ( n = 505 ) had a better median Romberg balance of 94 seconds ( interquartile range [ IQR ] , 75 - 118s ) than women with 1 , 2 , or 3 or more fractures , who had a median balance of 88 seconds ( IQR , 71 - 111s ) , 85 seconds ( IQR , 68 - 107s ) , and 81 seconds ( IQR , 65 - 109s ) , respectively ( Kruskal-Wallis analysis of variance , P = .002 ) . Balance was inferior in women who had sustained a previous fracture between the ages of 65 and 75 years compared with women with no previous fractures or fractures before the age of 65 years . Gait speed and questions on tendency to fall followed the same pattern . The computerized sway test could not differ between women with and without previous fractures . CONCLUSIONS Poor physical performance is associated with previous fractures . Inferior physical performance may exist up to 10 years after a fracture",
"The aim of this study was to analyse in particular dependence in instrumental daily life activities ( I-ADLs ) and its association with physical impairments and functional limitations in the elderly . The study was based on cross-sectional data on 70-year-olds ( n = 602 ) and longitudinal data on subjects followed up to the age of 76 ( n = 371 ) . Persons dependent in ADL had lower values in maximum walking speed , grip strength , knee extensor strength , stair climbing capacity and in forward reach , compared with those who were independent in ADL . Walking speed in both women and men and sight impairment in men had the greatest influence on dependence in ADL . Possible critical levels for disability in ADL are discussed , as persons who developed dependence between 70 and 76 already had a lower capacity in walking speed and knee extensor strength at age 70 than persons who retained their independence in ADL ",
"OBJECTIVES To assess the ability of gait speed alone and a three-item lower extremity performance battery to predict 12-month rates of hospitalization , decline in health , and decline in function in primary care setting s serving older adults . DESIGN Prospect i ve cohort study . SETTING Primary care programs of a Medicare health maintenance organization ( HMO ) and Veterans Affairs ( VA ) system . PARTICIPANTS Four hundred eighty-seven persons aged 65 and older . MEASUREMENTS Lower extremity performance Established Population for Epidemiologic Studies of the Elderly ( EPESE ) battery including gait speed , chair st and s , and t and em balance tests ; demographics ; health care use ; health status ; functional status ; probability of repeated admission scale ( Pra ) ; and primary physician 's hospitalization risk estimate . RESULTS Veterans had poorer health and higher use than HMO members . Gait speed alone and the EPESE battery predicted hospitalization ; 41 % ( 21/51 ) of slow walkers ( gait speed hospitalized at least once , compared with 26 % ( 70/266 ) of intermediate walkers ( 0.6 - 1.0 m/s ) and 11 % ( 15/136 ) of fast walkers ( > 1.0 m/s ) ( P decline in function and health status in both health systems . Performance measures , alone or in combination with self-report measures , were more able to predict outcomes than self-report alone . CONCLUSION Gait speed and a physical performance battery are brief , quantitative estimates of future risk for hospitalization and decline in health and function in clinical population s of older adults . Physical performance measures might serve as easily accessible \" vital signs \" to screen older adults in clinical setting ",
"BACKGROUND Some studies have proposed chronic inflammation as an underlying biological mechanism responsible for physical function decline in elderly people . The aim of this study is to evaluate the relationship between several inflammatory markers and physical performance in an older population . METHODS This study is part of the \" Invecchiare in Chianti \" ( InCHIANTI ) study , a prospect i ve population -based study of older people , aim ed at identifying risk factors for late-life disability . The study sample consisted of 1020 participants aged 65 years and older living in the Chianti area of Italy . Physical performance was assessed using walking speed , the chair-st and test , and the st and ing balance test . H and -grip strength was assessed using a h and -held dynamometer . Serum levels of C-reactive protein ( CRP ) , interleukin (IL)-6 , tumor necrosis factor-alpha ( TNF-alpha ) , IL-10 , IL-1beta , IL-6sR , and IL-1RA were determined . Linear regression analyses were used to assess the multivariate relationship of inflammatory marker levels with physical performance , scored as a continuous variable from 0 to 3 , and h and -grip strength after adjustment for demographics , chronic conditions , medication use , and other biological variables . RESULTS CRP , IL-6 , and IL1RA were significantly correlated with physical performance ( r=-0.162 , r=-0.251 , and r=-0.127 , respectively ) . Significant correlations with h and -grip strength were found for CRP and IL-6 ( r=-0.081 and r=-0.089 , respectively ) . After adjustment for covariates , high levels of IL-6 and IL-1RA continued to be strongly associated with worse physical performance ( p of CRP ( p IL-6 ( p low h and -grip strength . Mean adjusted physical performance scores ranged from 2.21 in the CRP0.60 mg/dl group ( p for trend=.004 ) , and from 2.25 in the lowest IL-6 quartile to 2.08 in the highest IL-6 quartile ( p for trend adjusted h and -grip strength , with a range from 28.8 kg for the CRP0.60 mg/dl group ( p for trend=.001 ) , and from 27.4 kg for the lowest IL-6 quartile to 25.1 kg for the highest IL-6 quartile ( p for trend=.001 ) . CONCLUSIONS Inflammation , measured as high levels of IL-6 , CRP , and IL-1RA , is significantly associated with poor physical performance and muscle strength in older persons . These data also support the biological face validity of physical performance measures . The assessment of inflammatory markers may represent a useful screening test and perhaps a potential target of intervention",
"BACKGROUND The relationship between cognitive function and physical disability in nondemented older adults is not well characterized . The purpose of this study was to determine the relationship between performance on psychometric measures and a modified Physical Performance Test ( modified PPT ) in older men and women . METHODS One hundred twenty-five men and women aged 75 years and older , who were enrolled in r and omized , controlled trials of exercise or hormone replacement therapy , were recruited from the community-at-large and from congregate living sites . Measures obtained included Trailmaking A and B tests , Cancellation R and om Figure tests , Weschler Associate Learning and 20-minute Delayed Recall , Verbal Fluency test , a modified PPT , and self-reports about performance of activities of daily living , medication use , and hospitalization in the previous year . RESULTS Simple regression analysis demonstrated that speed of performance on the Trailmaking B and Cancellation R and om Figure tests was significantly associated with total modified PPT score ( r = .29 , p cognitive speed factor and a memory factor , accounted for 55 % of the variance in cognitive test performance . Hierarchical multiple regression analyses demonstrated that age , number of medications , and the cognitive speed factor were independent predictors of total modified PPT score . CONCLUSIONS Cognitive processing speed is a significant component of physical frailty in this population , although it accounts for a small percentage of variance on a st and ardized physical performance test",
"Background : Fear of falling ( FF ) is pervasive among older people and is an independent risk factor for decreased mobility and loss of quality of life . Although it is a serious health concern , little is known about the severity of the physical and health-related deficits in high-functioning fearful seniors . Objective : This study examined the physical correlates of FF in community-dwelling seniors in relation to their non-fearful counterparts and also explored the relevance of recent fall history . Subjects : Twenty-five volunteers who stated that they had curtailed their activities due to a FF and who reported themselves to be healthy participated . Non-fearful , age- and gender-matched subjects were also recruited and served as a comparison group . Methods : This cross-sectional study had participants come to the laboratory on one occasion for about 1.5 h. Limits of balance stability , walking speed , and lower limb muscle strength were measured in r and om order . In addition , the SF-36 , the Activities-specific Balance Confidence ( ABC ) scale and the Human Activity Profile question naires were completed to provide measures of heath status , FF and activity levels , respectively . Results : Subjects with a FF had lower ABC scores ( 69.8 ± 10.2 ) than controls ( 90.2 ± 7.9 ; p > 0.05 ) . Balance ability was not compromised in seniors with a FF , although their walking speed was slower than that of control subjects ( p ) . Lower limb weakness was significant in the FF group , which also reported low physical health . Perceived physical health , activity and hip flexor torque in combination accounted for almost 62 % of the variance in ABC scores . Secondary analysis of the data from the FF group revealed a tendency for those who had fallen in the past year to restrict their limits of stability compared to those who had not fallen ; though generally the effect sizes were small to moderate . Conclusions : The marked deficits in strength and health status found among seniors living independently in the community , who are in good health , but report being fearful of falling underscores the seriousness of FF as a potential health risk factor in the well elderly",
"OBJECTIVES To determine , in a cohort of older individuals transitioning to frailty ( defined by Speechley and Tinetti , 1991 ) who have previously fallen , whether there are significant associations between demographic , functional , and behavioral characteristics and activity-related fear of falling , using both the Falls Efficacy Scale ( FES ) and the Activities-Specific Balance Confidence Scale ( ABC ) . DESIGN Baseline cross-sectional analysis in a prospect i ve cohort intervention study . SETTING Twenty independent senior living facilities in Atlanta . PARTICIPANTS Seventeen male and 270 female subjects ( n = 287 ) , age 70 and older ( mean + /- st and ard deviation , 80.9 + /- 6.2 ) , with Mini-Mental State Examination score > or = 24 , transitioning to frailty , ambulatory ( with or without assistive device ) , medically stable , and having fallen in the past year . MEASUREMENTS Activity-related fear of falling was evaluated with the FES and ABC Scale . Because of the comparable data derived from each scale , associations with functional measures -related analyses were expressed using the latter . Depression was measured by Center for Epidemiological Studies Depression Scale . Functional measurements included timed 360 degrees turn , functional reach test , timed 10-meter walk test , single limb st and s , picking up an object , and three chair st and s. RESULTS No statistically significant association was found between activity-related fear of falling and age . For the proposed activities , about half ( ABC , 48.1 % ; FES , 50.1 % ) of the subjects were concerned about falling or showed lack of confidence in controlling their balance . A statistically significant inverse correlation was found between FES and ABC ( r = -0.65 ; P African-American subjects showed more activity-related fear of falling than did Caucasians ( odds ratio ( OR ) : 2.7 for ABC ; 2.1 for FES ) . Fearful individuals were more likely to be depressed and more likely to report the use of a walking aid than were nonfearful individuals . Fear of falling was significantly correlated to all of the functional measurements ( P depression , using a walking-aid , slow gait speed , and being an African-American were directly related to being more fearful of falling . CONCLUSIONS Activity-related fear of falling was present in almost half of this sample of older adults transitioning to frailty . The significant association of activity-related fear of falling with demographic , functional , and behavioral characteristics emphasizes the need for multidimensional intervention strategies to lessen activity-related fear of falling in this population",
"BACKGROUND Increasing emphasis is being placed on physical performance measures as an outcome predictor . It is uncertain whether one or two simple measurements will have predictive value compared with a battery of tests . OBJECTIVES To assess whether simple performance measures such as walking speed and stride length will predict dependency , mortality , and institutionalization . DESIGN A 3-year longitudinal study of a r and om sample of subjects . SETTING Older people living in the community in Hong Kong , Special Administrative Region , China . SUBJECTS A total of 2032 Chinese subjects aged 70 years and older were recruited territory-wide by proportional r and om sampling and followed for 3 years . MEASUREMENTS Functional status was measured using the Barthel Index at baseline and follow-up . The time taken to walk a distance of 16 feet and the number of steps taken were measured at baseline . Stride length is estimated by dividing 16 by the average number of steps needed to complete the walk . Outcomes regarding dependency , mortality , and institutionalization at 36 months were recorded . RESULTS After excluding subjects lost to follow-up and those who had died , data were available for 559 men and 612 women . Univariate analysis showed that reduced walking speed and stride length were associated with increased risk of dependency , mortality , and institutionalization . In multivariate analysis for dependency and mortality , stride length , walking speed , age , and sex were included in the best prediction model ( ROC = 0.798 and 0.707 , respectively ) , whereas only stride length was included in the prediction for institutionalization ( ROC = 0.764 ) . CONCLUSIONS In terms of prevention or modifying outcomes , these two simple performance measures may be used as indicators for checking for occult disease and for interventional measures such as exercise prescription",
"OBJECTIVES To examine dog walking among dog owners and the relationship between walking behavior of dog owners and non-dog owners and maintained gait speed over 3 years . DESIGN Cross-sectional and longitudinal analyses of a prospect i ve cohort study . SETTING Memphis , Tennessee , and Pittsburgh , Pennsylvania . PARTICIPANTS Two thous and five hundred thirty-three community-dwelling adults aged 71 to 82 at 36 months of the Health , Aging and Body Composition Study . MEASUREMENTS Dog ownership , reported walking behavior , change in walking behavior , and usual and rapid gait speed over 3 years . RESULTS Of 394 dog owners , only 36 % walked their dogs at least three times per week . Cross-sectionally , dog walkers were more likely to achieve 150 minutes of walking per week and had faster usual and rapid walking speeds ( 1.20 vs 1.14 m/s and 1.62 vs 1.52 m/s , respectively ; P .50 ) . Three years later , subjects who had been dog walkers at baseline were approximately twice as likely as any other group to achieve recommended walking levels , independent of covariates . Dog walkers experienced similar declines in usual and rapid walking speed as non-dog owners who walked at least three times per week but maintained their initial mobility advantage . CONCLUSION Although dog ownership appears to facilitate walking behavior , only a minority of older dog owners walk their dogs . The mobility advantage of dog ownership was seen only in dog walkers and was similar to that associated with any walking . Given suboptimal walking activity in older adults , examining the degree to which dog ownership promotes walking activity in persons who do little walking on their own appears worth pursuing"
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QUESTION Is there a dose-response effect of exercise on inflammation , fatigue and activity in cancer survivors ? DESIGN Systematic review with meta-regression analysis of r and omised trials . PARTICIPANTS Adults diagnosed with cancer , regardless of specific diagnosis or treatment . INTERVENTION Exercise interventions including aerobic and /or resistance as a key component . OUTCOME MEASURES The primary outcome measures were markers of inflammation ( including C-reactive protein and interleukins ) and various measures of fatigue . The secondary outcomes were : measures of activity , as defined by the World Health Organization 's International Classification of Functioning , Disability and Health , including activities of daily living and measures of functional mobility ( eg , 6-minute walk test , timed sit-to-st and and stair-climb tests ) . Risk of bias was evaluated using the PEDro scale , and overall quality of evidence was assessed using the Grade s of Research , Assessment , Development and Evaluation ( GRADE ) approach . RESULTS Forty-two trials involving 3816 participants were included . There was very low- quality to moderate- quality evidence that exercise results in significant reductions in fatigue ( SMD 0.32 , 95 % CI 0.13 to 0.52 ) and increased walking endurance ( SMD 0.77 , 95 % CI 0.26 to 1.28 ) . A significant negative association was found between aerobic exercise intensity and fatigue reduction . A peak effect was found for moderate-intensity aerobic exercise for improving walking endurance . No dose-response relationship was found between exercise and markers of inflammation or exercise duration and outcomes . Rates of adherence were typically high and few adverse events were reported . CONCLUSIONS Exercise is safe , reduces fatigue and increases endurance in cancer survivors . The results support the recommendation of prescribing moderate-intensity aerobic exercise to reduce fatigue and improve activity in people with cancer . REVIEW REGISTRATION PROSPERO CRD42015019164
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"Physical activity is associated with improved breast cancer survival , but the underlying mechanisms , possibly including modification of the inflammatory state , are not well understood . We analyzed changes in interleukin (IL)-6 , C-reactive protein ( CRP ) , and TNF-α in a r and omized controlled trial of exercise in postmenopausal breast cancer survivors . Seventy-five women , recruited through the Yale-New Haven Hospital Tumor Registry , were r and omized to either a six-month aerobic exercise intervention or usual care . Correlations were calculated between baseline cytokines , adiposity , and physical activity measures . Generalized linear models were used to assess the effect of exercise on IL-6 , CRP , and TNF-α . At baseline , IL-6 and CRP were positively correlated with body fat and body mass index ( BMI ) and were inversely correlated with daily pedometer steps ( P of exercise on changes in inflammatory marker concentrations between women r and omized to exercise versus usual care , though secondary analyses revealed a significant reduction in IL-6 among exercisers who reached 80 % of the intervention goal compared with those who did not . Future studies should examine the effect of different types and doses of exercise and weight loss on inflammatory markers in large-scale trials of women diagnosed with breast cancer . Cancer Prev Res ; 6(2 ) ; 109–18 . © 2012 AACR",
"This pilot study examined the efficacy of two home-based exercise programs on alleviating fatigue and improving functional capacity in breast cancer survivors . Participants were r and omly assigned into one of three groups : aerobic exercise ( AE ) , resistance exercise ( RE ) , or usual care control ( CON ) . After receiving individualized instruction and training , participants assigned to the AE and RE groups were asked to perform the prescribed exercise(s ) 3 times per week for 12 weeks at home . Both groups were instructed to keep their perceived exercise intensity in the \" fairly light \" to \" somewhat hard \" range using the Borg Perceived Exertion Scale . All participants completed the revised Piper Fatigue Scale ( PFS ) and the 6-minute walk test ( 6MWT ) at baseline and 12-week post-exercise program . Analysis of pre- and post-training data revealed a significant reduction in fatigue levels on the PFS among participants in the AE group ( Z=2.521 , one-tailed P=0.006 ) , and a significant improvement in the distance of the 6MWT for the RE group ( Z=2.366 , one-tailed P=0.009 ) at the end of 12-week study period . No significant changes in fatigue or functional status were observed in the CON group . Findings provide preliminary support for RE as a viable strategy for improving functional capacity in breast cancer survivors , while AE may be more effective in attenuating cancer-related fatigue . Incorporating RE training for future research may help advance the growing body of knowledge in symptom management for breast cancer survivors",
"PURPOSE The primary purpose of this study was to examine the effect of aerobic exercise on physiological and psychological function in patients rehabilitating from cancer treatment . A second purpose was to evaluate the differential effects of low- and moderate-intensity exercise on these variables . METHODS Eighteen survivors of breast or colon cancer ( 15 female and 3 male , 40 - 65 yr of age ) served as subjects . The subjects were matched by aerobic capacity and scores on a Quality of Life question naire , and then r and omly assigned to a control , low- ( 25 - 35 % heart rate reserve ( HRR ) ) , or a moderate- ( 40 - 50 % HRR ) intensity exercise group . The exercise groups performed lower-body aerobic exercise three times a week for 10 wk . After the exercise training , there were no statistically significant differences between the two exercise groups on any of the physiological variables . Therefore , the exercise groups were combined into one group for the final analysis . RESULTS The results revealed statistically significant increases in aerobic capacity ( P lower-body flexibility ( P = 0.027 ) , a significant decrease in body fat ( P quality of life ( P a measure of energy ( P = 0.038 ) in the exercise group when compared with the control group . CONCLUSION Low- and moderate-intensity aerobic-exercise programs were equally effective in improving physiological and psychological function in this population of cancer survivors . Aerobic exercise appears to be a valuable and well-tolerated component of the cancer-rehabilitation process",
"Goals of workProstate cancer patients receiving and rogen deprivation therapy ( ADT ) are vulnerable to a number of potentially debilitating side effects , which can significantly impact quality of life . The role of alternate therapies , such as physical activity ( PA ) , in attenuating these side effects is largely understudied for such a large population . Thus , the purpose of this study was to investigate the effects of PA intervention for men receiving ADT on PA behavior , quality of life , and fitness measures . Patients and methods One hundred participants were r and omized into an intervention ( n = 53 ) or a wait-list control group ( n = 47 ) , with 11 dropping out of the intervention group and 23 dropping out of the wait-list control group prior to post-testing . The intervention consisted of both an individually tailored home-based aerobic and light resistant training program and weekly group sessions . PA , quality of life , fitness , and physiological outcomes were assessed pre and post the 16-week intervention . Results Significant increases in PA , supported by changes in girth measures and blood pressure , support the beneficial impact of the intervention . Positive trends were also evident for depression and fatigue . However , due to the high dropout rate , these results must be interpreted with caution . Conclusions PA effectively attenuates many of the side effects of ADT and should be recommended to prostate survivors as an alternate therapy . Determining the maintenance of this behavior change will be important for underst and ing how the long-term benefits of increased activity levels may alleviate the late effects of ADT",
"The purpose of this r and omized , controlled clinical trial was to preliminarily examine the effects of a three-week walking exercise program ( WEP ) on fatigue-related experiences of acute myelogenous leukemia ( AML ) patients receiving chemotherapy . Eligible AML patients were r and omly assigned to either an experimental group ( n=11 ) , which received 12 minutes of WEP per day , five days per week for three consecutive weeks , or to a control group ( n=11 ) , which received st and ard ward care . Effects of the WEP were assessed by seven indicators : worst and average fatigue intensities , fatigue interference with patients ' daily life , 12-minute walking distance , overall symptom distress , anxiety , and depressive status . All patients were evaluated four times : before chemotherapy ( baseline or Day 1 ) , Day 7 , Day 14 , and Day 21 of chemotherapy . Data were analyzed by Generalized Estimating Equation and revealed that AML patients in the three-week WEP group had a significantly greater increase in 12-minute walking distance than the control group . Patients in the WEP also had lower levels of fatigue intensity and interference , symptom distress , anxiety , and depressive status than the control group . Although preliminary , our results strongly suggest that three weeks of systematic walking exercise is clinical ly feasible for AML patients undergoing chemotherapy and can effectively improve their fatigue-related experiences",
"The objective was to determine the effects of exercise training on changes in blood immune function in postmenopausal breast cancer survivors . Fifty-three postmenopausal breast cancer survivors were r and omly assigned to an exercise ( n=25 ) or control group ( n=28 ) . The exercise group trained on cycle ergometers three times per week for 15 wk . The control group did not train . The primary end point was change in natural killer cell cytotoxic activity in isolated peripheral blood mononuclear cells . Secondary end points were changes in st and ard hematological variables , whole blood neutrophil function , the phenotypes of isolated mononuclear cells , estimations of unstimulated and phytohemaglutinin-stimulated mononuclear cell function ( rate of [3H]thymidine uptake ) , and the production of proinflammatory [ interleukin (IL)-1alpha , tumor necrosis factor-alpha , IL-6 ] and anti-inflammatory cytokines ( IL-4 , IL-10 , transforming growth factor-beta1 ) . Statistical tests were two-sided ( alpha Fifty-two participants completed the trial . Intention-to-treat analyses , which included the baseline value as a covariate , showed significant differences between groups for change in percent specific lysis of a target natural killer cell at all five effector-to-target ratios ( adjusted mean between-group change over all 5 effector-to-target ratios = + 6.34 % ; P lytic activity per cell ( adjusted mean between-group change = -2.72 lytic units ; P=0.035 ) , and unstimulated [3H]thymidine uptake by peripheral blood lymphocytes ( adjusted mean between-group change = + 218 per dpm x 10(6 ) cells ; P = 0.007 ) . There were no significant differences between groups for change in any other end point . Exercise training increased natural killer cell cytotoxic activity and unstimulated [3H]thymidine uptake by peripheral blood lymphocytes in postmenopausal breast cancer survivors",
"Introduction Older breast cancer survivors ( BCS ) report more falls and functional limitations than women with no cancer history . Exercise training could reduce risk factors for future falls and disability . Methods We conducted a r and omized , controlled trial in 106 early-stage , postmenopausal BCS who were ≥50 years old at diagnosis and post-treatment . Women were r and omly assigned to a 1-year resistance + impact exercise program or a stretching placebo program . Endpoints were one repetition maximum bench press and leg press strength , timed five chair st and s , 4 m usual walk speed , timed stance tests , h and grip strength , self-report physical function , and fatigue . We also examined the influence of age , adjuvant hormone therapy use , and exercise adherence on study outcomes . Results Women in the resistance + impact training program significantly improved maximal leg ( p .02 ) and bench ( p .02 ) press strength compared to the stretching group . Women who attended 50 % or more of prescribed resistance training sessions had significantly better changes in maximal strength measures compared to less adherent women . Conclusions Resistance + impact exercise is superior to stretching at improving maximal muscle strength and exercise adherence contributes to the degree of improvement . Implication s for cancer survivorsOlder BCS can safely engage in resistance exercise that improves lower and upper body strength , thereby reducing a risk factor for falls and future disability . However , the ability of resistance training to shift other indices of fall and disability risk , i.e. , balance and function , is unclear . Strategies to promote adherence to resistance training could lead to greater improvements in strength ",
"Purpose This study aims to evaluate the feasibility and efficacy of an 8-week supervised exercise program in de-conditioned cancer survivors within 2–6 months of chemotherapy completion . Methods Participants were r and omly assigned to an 8-week , twice-weekly , supervised aerobic exercise training regime ( n = 23 ) or a usual care group ( n = 20 ) . Feasibility was assessed by recruitment rate , program adherence and participant feedback . The primary outcome was aerobic fitness assessed by the Modified Bruce fitness test at baseline ( 0 weeks ) , post-intervention ( 8 weeks ) and at 3-month follow-up . Secondary outcomes included physical activity , waist circumference , fatigue and quality of life . Results The recruitment rate was 81 % and adherence to the supervised exercise was 78.3 % . Meaningful differences in aerobic fitness between the exercise and usual care groups at both the 8-week [ mean 3.0 mL kg−1 min−1 ( 95 % CI −1.1–7.0 ) ] and 3-month follow-up [ 2.1 mL kg−1 min−1 ( −2.3–6.6 ) ] were found , although these differences did not achieve statistical significance ( p values > 0.14 ) . Self-reported physical activity increased in the exercise group ( EG ) compared to the usual care group at both 8-week ( p = 0.01 ) and 3-month follow-up ( p = 0.03 ) and significant differences in favour of the EG were found for physical well-being at both the 8-week ( p = 0.03 ) and 3-month follow-up ( p = 0.04 ) . Improvements in fatigue ( p = 0.01 ) , total quality of life plus fatigue ( p = 0.04 ) , and a composite physical functioning score ( p = 0.01 ) at the 3-month follow-up were also found . Conclusion The PEACH trial suggests that 8 weeks of supervised aerobic exercise training was feasible and may improve aerobic fitness , fatigue and quality of life in de-conditioned cancer survivors during the early survivorship phase . Implication s for Cancer SurvivorsExercise interventions commenced in the early survivorship phase appear safe , feasible and may lead to improvements in QOL and fatigue ",
"Advice to rest and take things easy if patients become fatigued during radiotherapy may be detrimental . Aerobic walking improves physical functioning and has been an intervention for chemotherapy‐related fatigue . A prospect i ve , r and omized , controlled trial was performed to determine whether aerobic exercise would reduce the incidence of fatigue and prevent deterioration in physical functioning during radiotherapy for localized prostate carcinoma",
"The purpose of this study was to examine the effects of an exercise intervention on the total caloric intake ( TCI ) of breast cancer patients undergoing treatment . A secondary purpose was to determine whether or not a relationship existed between changes in TCI , body fat composition ( % BF ) , and fatigue during the study , which lasted 6 months . Twenty females recently diagnosed with breast cancer , scheduled to undergo chemotherapy or radiation , were assigned r and omly to an experimental ( N = 10 ) or control group ( N = 10 ) . Outcome measures included TCI ( 3-day food diary ) , % BF ( skinfolds ) , and fatigue ( revised Piper Fatigue Scale ) . Each exercise session was conducted as follows : initial cardiovascular activity ( 6 - 12 min ) , followed by stretching ( 5 - 10 min ) , resistance training ( 15 - 30 min ) , and a cool-down ( approximately 8 min ) . Significant changes in TCI were observed among groups ( F1,18 = 8.582 ; P = 0.009 ) , at treatments 2 and 3 , and at the end of the study [ experimental ( 1973 + /- 419 ) , control ( 1488 + /- 418 ) ; experimental ( 1946 + /- 437 ) , control ( 1436 + /- 429 ) ; experimental ( 2315 + /- 455 ) , control ( 1474 + /- 294 ) , respectively ] . A significant negative correlation was found ( Spearman rho(18 ) = -0.759 ; P TCI and % BF and between TCI and fatigue levels ( Spearman rho(18 ) = -0.541 ; P = 0.014 ) at the end of the study . In conclusion , the results of this study suggest that an exercise intervention administered to breast cancer patients undergoing medical treatment may assist in the mitigation of some treatment side effects , including decreased TCI , increased fatigue , and negative changes in body composition",
"Background : Few exercise trials in cancer patients have reported longer-term follow-up . Here , we report a 6-month follow-up of exercise behavior and patient-rated outcomes from an exercise trial in breast cancer patients . Methods : Breast cancer patients initiating adjuvant chemotherapy ( n = 242 ) were r and omly assigned to usual care ( n = 82 ) , resistance exercise training ( RET ; n = 82 ) , or aerobic exercise training ( AET ; n = 78 ) for the duration of their chemotherapy . At 6-month follow-up , participants were mailed a question naire that assessed quality of life , self-esteem , fatigue , anxiety , depression , and exercise behavior . Results : Two hundred one ( 83.1 % ) participants provided 6-month follow-up data . Adjusted linear mixed-model analyses showed that , at 6-month follow-up , the RET group reported higher self-esteem [ adjusted mean difference , 1.6 ; 95 % confidence interval ( 95 % CI ) , 0.1 - 3.2 ; P = 0.032 ] and the AET group reported lower anxiety ( adjusted mean difference , −4.7 ; 95 % CI , −0.0 to −9.3 ; P = 0.049 ) compared with the usual care group . Moreover , compared with participants reporting no regular exercise during the follow-up period , those reporting regular aerobic and resistance exercise also reported better patient-rated outcomes , including quality of life ( adjusted mean difference , 9.5 ; 95 % CI , 1.2 - 17.8 ; P = 0.025 ) . Conclusions : Improvements in self-esteem observed with RET during breast cancer chemotherapy were maintained at 6-month follow-up whereas reductions in anxiety not observed with AET during breast cancer chemotherapy emerged at 6-month follow-up . Moreover , adopting a combined aerobic and resistance exercise program after breast cancer chemotherapy was associated with further improvements in patient-rated outcomes . Exercise training during breast cancer chemotherapy may result in some longer-term and late effects for selected patient-rated outcomes . ( Cancer Epidemiol Biomarkers Prev 2007;16(12):2572–8",
"PURPOSE S/ OBJECTIVES To test the hypothesis that women participating in a walking exercise program during radiation therapy treatment for breast cancer would demonstrate more adaptive responses as evidence d by higher levels of physical functioning and lower levels of symptom intensity than women who did not participate . DESIGN Experimental , two-group pretest , post-test . SETTING Two university teaching hospital outpatient radiation therapy departments . SAMPLE 46 women beginning a six-week program of radiation therapy for early stage breast cancer . METHODS Following r and om assignment , subjects in the exercise group maintained an individualized , self-paced , home-based walking exercise program throughout treatment . The control group received usual care . Dependent variables were measured prior to and at the end of radiation therapy . In addition , symptoms were assessed at the end of three weeks of treatment . MAIN RESEARCH VARIABLES Participation in the walking exercise program , physical functioning fatigue , emotional distress , and difficulty sleeping . FINDINGS Hypothesis testing by multivariate analysis of covariance , with pretest scores as covariates , indicated significant differences between groups on outcome measures ( p physical functioning ( p = 0.003 ) and symptom intensity , particularly fatigue , anxiety , and difficulty sleeping . Fatigue was the most frequent and intense subjective symptom reported . CONCLUSIONS A self-paced , home-based walking exercise program can help manage symptoms and improve physical functioning during radiation therapy . IMPLICATION S FOR NURSING PRACTICE Nurse-prescribed and -monitored exercise is an effective , convenient , and low-cost self-care activity that reduces symptoms and facilitates adaptation to breast cancer diagnosis and treatment",
"Objectives To determine functional and psychological benefits of a 12 week supervised group exercise programme during treatment for early stage breast cancer , with six month follow-up . Design Pragmatic r and omised controlled prospect i ve open trial . Setting Three National Health Service oncology clinics in Scotl and and community exercise facilities . Participants 203 women entered the study ; 177 completed the six month follow-up . Interventions Supervised 12 week group exercise programme in addition to usual care , compared with usual care . Main outcome measures Functional assessment of cancer therapy ( FACT ) question naire , Beck depression inventory , positive and negative affect scale , body mass index , seven day recall of physical activity , 12 minute walk test , and assessment of shoulder mobility . Results Mixed effects models with adjustment for baseline values , study site , treatment at baseline , and age gave intervention effect estimates ( intervention minus control ) at 12 weeks of 129 ( 95 % confidence interval 83 to 176 ) for metres walked in 12 minutes , 182 ( 75 to 289 ) for minutes of moderate intensity activity reported in a week , 2.6 ( 1.6 to 3.7 ) for shoulder mobility , 2.5 ( 1.0 to 3.9 ) for breast cancer specific subscale of quality of life , and 4.0 ( 1.8 to 6.3 ) for positive mood . No significant effect was seen for general quality of life ( FACT-G ) , which was the primary outcome . At the six month follow-up , most of these effects were maintained and an intervention effect for breast cancer specific quality of life emerged . No adverse effects were noted . Conclusion Supervised group exercise provided functional and psychological benefit after a 12 week intervention and six months later . Clinicians should encourage activity for their patients . Policy makers should consider the inclusion of exercise opportunities in cancer rehabilitation services . Trial registration Current controlled trials IS RCT N12587864",
"CONTEXT Physical activity has been shown to decrease the incidence of breast cancer , but the effect on recurrence or survival after a breast cancer diagnosis is not known . OBJECTIVE To determine whether physical activity among women with breast cancer decreases their risk of death from breast cancer compared with more sedentary women . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve observational study based on responses from 2987 female registered nurses in the Nurses ' Health Study who were diagnosed with stage I , II , or III breast cancer between 1984 and 1998 and who were followed up until death or June 2002 , whichever came first . MAIN OUTCOME MEASURE Breast cancer mortality risk according to physical activity category ( or = 24 metabolic equivalent task [ MET ] hours per week ) . RESULTS Compared with women who engaged in less than 3 MET-hours per week of physical activity , the adjusted relative risk ( RR ) of death from breast cancer was 0.80 ( 95 % confidence interval [ CI ] , 0.60 - 1.06 ) for 3 to 8.9 MET-hours per week ; 0.50 ( 95 % CI , 0.31 - 0.82 ) for 9 to 14.9 MET-hours per week ; 0.56 ( 95 % CI , 0.38 - 0.84 ) for 15 to 23.9 MET-hours per week ; and 0.60 ( 95 % CI , 0.40 - 0.89 ) for 24 or more MET-hours per week ( P for trend = .004 ) . Three MET-hours is equivalent to walking at average pace of 2 to 2.9 mph for 1 hour . The benefit of physical activity was particularly apparent among women with hormone-responsive tumors . The RR of breast cancer death for women with hormone-responsive tumors who engaged in 9 or more MET-hours per week of activity compared with women with hormone-responsive tumors who engaged in less than 9 MET-hours per week was 0.50 ( 95 % CI , 0.34 - 0.74 ) . Compared with women who engaged in less than 3 MET-hours per week of activity , the absolute unadjusted mortality risk reduction was 6 % at 10 years for women who engaged in 9 or more MET-hours per week . CONCLUSIONS Physical activity after a breast cancer diagnosis may reduce the risk of death from this disease . The greatest benefit occurred in women who performed the equivalent of walking 3 to 5 hours per week at an average pace , with little evidence of a correlation between increased benefit and greater energy expenditure . Women with breast cancer who follow US physical activity recommendations may improve their survival",
"OBJECTIVE To investigate the effectiveness of an 8-week aquatic program on cancer-related fatigue , as well as physical and psychological outcomes in breast cancer survivors . DESIGN A r and omized controlled trial . SETTING Outpatient clinic , urban , academic medical center , and a sport university swimming pool . PARTICIPANTS Breast cancer survivors ( N=68 ) were r and omly assigned to either an experimental ( aquatic exercise group in deep water pool ) group or a control ( usual care ) group . INTERVENTIONS The intervention group attended aquatic exercise sessions 3 times per week for 8 weeks in a heated deep swimming pool . Sessions lasted 60 minutes in duration : 10 minutes of warm-up , 40 minutes of aerobic and endurance exercises , and 10 minutes of cool-down exercises . Patients allocated to the usual care group followed the oncologist 's recommendations in relation to a healthy lifestyle . MAIN OUTCOME MEASURES Values for fatigue ( Piper Fatigue Scale ) , mood state ( Profile of Mood States ) , and abdominal ( trunk curl static endurance test ) and leg ( multiple sit-to-st and test ) strength were collected at baseline , after the last treatment session , and at a 6-month follow-up . RESULTS Immediately after discharge , the aquatic exercise group showed a large effect size in total fatigue score ( d=.87 ; 95 % confidence interval , .48 - 1.26 ) , trunk curl endurance ( d=.92 ; 95 % confidence interval , 1.97 - 3.83 ) , and leg strength ( d=1.10 ; .55 - 2.76 ) , but negligible effects in vigor , confusion , and disturbance of mood ( d aquatic exercise group maintained large to small effect sizes in fatigue scores , multiple sit-to-st and test , and trunk curl static endurance ( .25>d>.90 ) and negligible effects for the fatigue-severity dimension and different scales of the Profile of Mood States ( d aquatic exercise program conducted in deep water was effective for improving cancer-related fatigue and strength in breast cancer survivors",
"PURPOSE To examine the effects of aerobic exercise therapy on quality of life ( QoL ) and associated outcomes in women treated for breast cancer . Evidence suggests that exercise may be beneficial , but no trial has included an exercise-placebo and a usual-care group to control for the attention effects that might be associated with aerobic exercise interventions in cancer patients . PATIENTS AND METHODS A total of 108 women who had been treated for breast cancer 12 to 36 months previously were r and omly assigned to supervised aerobic exercise therapy ( n = 34 ) , exercise-placebo ( body conditioning ; n = 36 ) , or usual care ( n = 38 ) . Exercise therapy and exercise-placebo sessions took place three times per week for 8 weeks . Outcomes included QoL , depression , exercise behavior , aerobic fitness ; outcomes were assessed at baseline and at the 8- and 24-week follow-up . RESULTS Analyses of covariance revealed a significant mean difference of 9.8 units in Functional Assessment of Cancer Therapy-General ( primary outcome ) favoring aerobic exercise therapy at 8 weeks , relative to usual care . Significant differences that favored aerobic exercise therapy relative to usual care were recorded for Functional Assessment of Cancer Therapy-Breast , social/family well-being , functional well-being , and breast cancer subscale scores at 8-week follow-up . Psychological health outcomes improved modestly for both intervention groups ; these improvements were sustained for several end points . CONCLUSION Exercise therapy had large , clinical ly meaningful , short-term beneficial effects on QoL in women treated for breast cancer ; this finding can not be attributable to attention , given that the exercise-placebo group did not report similar effects relative to usual care",
"PURPOSE Breast cancer chemotherapy may cause unfavorable changes in physical functioning , body composition , psychosocial functioning , and quality of life ( QOL ) . We evaluated the relative merits of aerobic and resistance exercise in blunting these effects . PATIENTS AND METHODS We conducted a multicenter r and omized controlled trial in Canada between 2003 and 2005 that r and omly assigned 242 breast cancer patients initiating adjuvant chemotherapy to usual care ( n = 82 ) , supervised resistance exercise ( n = 82 ) , or supervised aerobic exercise ( n = 78 ) for the duration of their chemotherapy ( median , 17 weeks ; 95 % CI , 9 to 24 weeks ) . Our primary end point was cancer-specific QOL assessed by the Functional Assessment of Cancer Therapy-Anemia scale . Secondary end points were fatigue , psychosocial functioning , physical fitness , body composition , chemotherapy completion rate , and lymphedema . RESULTS The follow-up assessment rate for our primary end point was 92.1 % , and adherence to the supervised exercise was 70.2 % . Unadjusted and adjusted mixed-model analyses indicated that aerobic exercise was superior to usual care for improving self-esteem ( P = .015 ) , aerobic fitness ( P = .006 ) , and percent body fat ( adjusted P = .076 ) . Resistance exercise was superior to usual care for improving self-esteem ( P = .018 ) , muscular strength ( P lean body mass ( P = .015 ) , and chemotherapy completion rate ( P = .033 ) . Changes in cancer-specific QOL , fatigue , depression , and anxiety favored the exercise groups but did not reach statistical significance . Exercise did not cause lymphedema or adverse events . CONCLUSION Neither aerobic nor resistance exercise significantly improved cancer-specific QOL in breast cancer patients receiving chemotherapy , but they did improve self-esteem , physical fitness , body composition , and chemotherapy completion rate without causing lymphedema or significant adverse events",
"The authors investigated associations between serum C-reactive protein ( CRP ) concentrations and colon and rectal cancer risk in a nested case-control study within the European Prospect i ve Investigation into Cancer and Nutrition ( 1992 - 2003 ) among 1,096 incident cases and 1,096 controls selected using risk-set sampling and matched on study center , age , sex , time of blood collection , fasting status , menopausal status , menstrual cycle phase , and hormone replacement therapy . In conditional logistic regression with adjustment for education , smoking , nutritional factors , body mass index , and waist circumference , CRP showed a significant nonlinear association with colon cancer risk but not rectal cancer risk . Multivariable-adjusted relative risks for CRP concentrations of > or = 3.0 mg/L versus Colon cancer risk was significantly increased in men ( relative risk = 1.74 , 95 % CI : 1.11 , 2.73 ; P-trend = 0.01 ) but not in women ( relative risk = 1.06 , 95 % CI : 0.67 , 1.68 ; P-trend = 0.13 ) . Additional adjustment for C-peptide , glycated hemoglobin , and high density lipoprotein cholesterol did not attenuate these results . These data provide evidence that elevated CRP concentrations are related to a higher risk of colon cancer but not rectal cancer , predominantly among men and independently of obesity , insulin resistance , and dyslipidemia",
"PURPOSE / OBJECTIVES To compare the effectiveness of a prescribed home-based walking exercise intervention with usual care in older women receiving hormonal treatment for breast cancer , and to examine relationships among levels of the cortisol , serotonin , interleukin-6 , and bilirubin biomarkers and fatigue , sleep disturbances , and depressive symptoms . DESIGN Longitudinal r and omized clinical trial . SETTING A National Cancer Institute- design ated cancer center in the southeastern United States . SAMPLE 20 women ( aged 55 years or older ) with breast cancer receiving hormonal treatment . METHODS Participants were r and omized to a walking exercise intervention or usual care . Laboratory sample s and the Pittsburgh Sleep Quality Index ( PSQI ) , the Piper Revised Fatigue Scale , and the Center for Epidemiological Studies -Depression Scale were collected at the initial clinic visit and at 12 weeks from the groups . Question naires also were collected at weeks 2 and 14 . MAIN RESEARCH VARIABLES Fatigue , sleep disturbances , depressive symptoms , biomarkers , and exercise . FINDINGS Effect of the exercise intervention on sleep scores was highly significant between groups . Exercise group scores on the PSQI decreased significantly over time ( indicating improved sleep quality ) , although scores did not change significantly within the control group . Sleep actigraphy also showed significantly shorter actual wake time and less movement in the exercise group . Serotonin levels also were significantly affected by the intervention . CONCLUSIONS Data suggest that a walking exercise intervention improves sleep in older women receiving hormonal treatment for their breast cancer . Serotonin levels may be a useful biomarker when assessing sleep disturbances in this group . IMPLICATION S FOR NURSING Clinicians need to be aware that older women receiving hormonal treatment for their breast cancer may experience fatigue , sleep disturbances , and depressive symptoms . Homebased walking activity may reduce symptom severity in this group",
"OBJECTIVE To show fatigue prevention and quality of life ( QOL ) improvement from cardiovascular exercise during radiotherapy . DESIGN Prospect i ve enrollment ( n=21 ) , r and omized to exercise ( n=11 ) and control groups ( n=10 ) , with pre- and post-radiotherapy between- and within-group comparisons . SETTING Academic medical center . PARTICIPANTS Localized prostate cancer patients undergoing radiotherapy . INTERVENTIONS The interventional group received radiotherapy plus aerobic exercise 3 times a week for 8 weeks whereas the control group received radiotherapy without exercise . MAIN OUTCOME MEASURES Pre- and post-radiotherapy differences in cardiac fitness , fatigue , depression , functional status , physical , social , and functional well-being , leg strength , and flexibility were examined within and between 2 groups . RESULTS No significant differences existed between 2 groups at pre-radiotherapy assessment . At post-radiotherapy assessment , the exercise group showed significant within group improvements in : cardiac fitness ( P fatigue ( P=.02 ) , Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) ( P=.04 ) , physical well-being ( P=.002 ) , social well-being ( P=.02 ) , flexibility ( P=.006 ) , and leg strength ( P=.000 ) . Within the control group , there was a significant increase in fatigue score ( P=.004 ) and a decline in social well-being ( P cardiac fitness ( P=.006 ) , strength ( P=.000 ) , flexibility ( P fatigue ( P FACT-P ( P=.006 ) , physical well-being ( P social well-being ( P=.002 ) , and functional well-being ( P=.04 ) . CONCLUSIONS An 8-week cardiovascular exercise program in patients with localized prostate cancer undergoing radiotherapy improved cardiovascular fitness , flexibility , muscle strength , and overall QOL and prevented fatigue",
"The purpose of this r and omized controlled trial was to determine the effects of an 8-week ( aerobic+strength ) exercise training program ( 3 sessions/week ) on the circulating cytokine levels of breast cancer survivors . We r and omly allocated 16 female survivors of breast cancer ( mean±SD age : 50±5 years ) to an intervention or usual care ( control ) group ( N=8 in each group ) . The intervention group followed an 8-week exercise program consisting of 3 sessions/week ( session duration : 90 min ) . We measured the levels of the following cytokines before and after the intervention : beta-NGF , CTACK , eotaxin , FGF basic , G-CSF , gmCSFα , HGF , ICAM1 , IFNα2 , IFNγ , IL1α , IL1ß , IL1ra , IL2 , IL2ra , IL3 , IL4 , IL6 , IL7 , IL8 , IL9 , IL10 , IL12 , IL13 , IL15 , IL16 , IL17 , IL18 , IP10 , LIF , MCS-F , MIP1α , MIP1β , MIF , MCP1 , MCP3 , MIG , PDGF bb , SCF , SCGFβ , SDF1α , TRAIL , TNFα , TNFβ , VCAM1 , and VEGF . We only observed a significant interaction ( group*time ) effect for CTACK ( P=0.016 ) , with mean values remaining stable in the intervention group but increasing over time in controls . The intervention program did not induce a significant decrease in the main breast cancer-related cytokines such as IL6 and IL8 . A combined ( aerobic+strength ) 8-week exercise training intervention did not induce major changes in the basal cytokine levels of breast cancer survivors",
"This pilot study examined whether exercise as an adjunctive rehabilitation therapy could benefit women who have early stage breast cancer and are currently receiving chemotherapy/radiotherapy . The study was design ed as a r and omised controlled trial ( RCT ) . Physical functioning , fatigue and Quality of Life ( QoL ) outcomes were evaluated pre and post a 12-week intervention . The results showed that after 12 weeks the women who participated in the exercise programme ( n = 12 ) displayed significantly higher levels of physical functioning and reported higher QoL scores than the controls ( n = 10 ) . Changes in fatigue and satisfaction with life favoured the intervention group but did not reach significance . These results are encouraging and suggest that a structured group exercise programme during adjuvant treatment is a safe , well tolerated and effective way of providing physical and psychological health benefits to women during treatment for early stage breast cancer . Since this was a pilot study the numbers did not allow appropriately powered analyses of some variables of interest and favoured relatively young and socio-economically advantaged women . Future studies need to address these issues and determine if these short-term benefits can be sustained",
"PURPOSE / OBJECTIVES To compare usual care with a home-based individualized exercise program ( HBIEP ) in patients receiving intensive treatment for multiple myeloma ( MM ) and epoetin alfa therapy . DESIGN R and omized trial with repeated measures of two groups ( one experimental and one control ) and an approximate 15-week experimental period . SETTING Outpatient setting of the Myeloma Institute for Research and Therapy at the Rockfellow Cancer Center at the University of Arkansas for Medical Sciences . SAMPLE 187 patients with newly diagnosed MM enrolled in a separate study evaluating effectiveness of the Total Therapy regimen , with or without thalidomide . METHODS Measurements included the Profile of Mood States fatigue scale , Functional Assessment of Cancer Therapy-Fatigue , ActiGraph ® recordings , 6-Minute Walk Test , and hemoglobin levels at baseline and before and after stem cell collection . Descriptive statistics were used to compare demographics and treatment effects , and repeated measures analysis of variance was used to determine effects of HBIEP . MAIN RESEARCH VARIABLES Fatigue , nighttime sleep , performance ( aerobic capacity ) as dependent or outcome measures , and HBIEP combining strength building and aerobic exercise as the independent variable . FINDINGS Both groups were equivalent for age , gender , race , receipt of thalidomide , hemoglobin levels , and type of treatment regimen for MM . No statistically significant differences existed among the experimental and control groups for fatigue , sleep , or performance ( aerobic capacity ) . Statistically significant differences ( p more fatigue and poorer nighttime sleep and performance ( aerobic capacity ) . CONCLUSIONS The effect of exercise seemed to be minimal on decreasing fatigue , improving sleep , and improving performance ( aerobic capacity ) . IMPLICATION S FOR NURSING Exercise is safe and has physiologic benefits for patients undergoing MM treatment ; exercise combined with epoetin alfa helped alleviate anemia",
"Purpose Cancer and its treatment-related side effects induce loss of physical performance . This study evaluated the effects of multimodal aerobic and strength exercises on physical performance in hospitalized cancer patients while receiving myeloablative chemotherapy . Methods In this prospect i ve pilot study , 48 evaluable patients were r and omly assigned to a training ( TG , n = 24 ) or control ( CG , n = 24 ) group . The TG performed an individually supervised exercise program five times a week with ergometer training and strength exercises for 20 min each during the hospitalization period for chemotherapy . The CG received st and ard physiotherapy . Physical performance was evaluated using spiroergometry , lung function , and muscle strength testing . Treatment-related side effects were assessed by daily interviews , quality of life by EORTC-QLQ-C30 , and fatigue using the Modified Fatigue Impact Scale ( MFIS ) question naire . Results Physical performance significantly increased in the TG ( 8.96 ± 24 W ) and decreased in the CG ( −7.24 ± 20 W , p = 0.02 ) . At 2-mmol/ml blood lactate concentration , the TG achieved significantly increased oxygen consumption ( p = 0.03 ) and expiratory minute ventilation ( p = 0.04 ) compared to the CG . Furthermore , physical functioning increased significantly in the TG ( p = 0.04 ) . Patients in the TG required less antiemetics ( p = 0.01 ) and experienced significantly less fatigue ( p = 0.04 ) , although MFIS analysis was not able to detect this beneficial effect . Patients of the CG displayed higher impairments of cognitive ( p = 0.02 ) and psychosocial function ( p = 0.03 ) after chemotherapy . No adverse events due to the study intervention were observed . Conclusions Multimodal exercise has beneficial effects on physical performance , physical functioning , and treatment-related symptoms even during myeloablative chemotherapy . We suggest an enhanced physical activity intervention program during hospitalization of cancer patients",
"1 . The present study investigates to what extent and by which time course prolonged strenuous exercise influences the plasma concentration of pro-inflammatory and inflammation responsive cytokines as well as cytokine inhibitors and anti-inflammatory cytokines . 2 . Ten male subjects ( median age 27.5 years , range 24 - 37 ) completed the Copenhagen Marathon 1997 ( median running time 3 : 26 ( h : min ) , range 2 : 40 - 4 : 20 ) . Blood sample s were obtained before , immediately after and then every 30 min in a 4 h post-exercise recovery period . 3 . The plasma concentrations of tumour necrosis factor (TNF)alpha , interleukin (IL)-1beta , IL-6 , IL-1ra , sTNF-r1 , sTNF-r2 and IL-10 were measured by enzyme-linked immunosorbent assay ( ELISA ) . The highest concentration of IL-6 was found immediately after the race , whereas IL-1ra peaked 1 h post exercise ( 128-fold and 39-fold increase , respectively , as compared with the pre-exercise values ) . The plasma level of IL-1beta , TNFalpha , sTNF-r1 and sTNF-r2 peaked in the first hour after the exercise ( 2 . 1- , 2.3- , 2.7- and 1.6-fold , respectively ) . The plasma level of IL-10 showed a 27-fold increase immediately post exercise . 4 . In conclusion , strenuous exercise induces an increase in the pro-inflammatory cytokines TNFalpha and IL-1beta and a dramatic increase in the inflammation responsive cytokine IL-6 . This is balanced by the release of cytokine inhibitors ( IL-1ra , sTNF-r1 and sTNF-r2 ) and the anti-inflammatory cytokine IL-10 . The study suggests that cytokine inhibitors and anti-inflammatory cytokines restrict the magnitude and duration of the inflammatory response to exercise",
"BACKGROUND Active for Life After Cancer is a r and omized trial evaluating the efficacy of a 6-month group-based lifestyle physical activity program ( Lifestyle ) for prostate cancer patients to improve quality of life ( QOL ) including physical and emotional functioning compared to a group-based Educational Support Program and a St and ard Care Program ( no group ) . METHOD A total of 134 prostate cancer patients receiving continuous and rogen-ablation were r and omly assigned to one of the three study conditions . RESULTS Results indicated no significant improvements in QOL at 6 or 12 months . Both group-based programs were positively received and yielded good attendance and retention . Lifestyle participants demonstrated significant improvements in most theoretical mediators proposed by the Transtheoretical Model and Social Cognitive Theory to affect physical activity . Despite these improvements , no significant changes were found for most physical activity measures . CONCLUSIONS Results suggest a lifestyle program focusing on cognitive-behavioral skills training alone is insufficient for promoting routine physical activity in these patients",
"OBJECTIVE To examine predictors of adherence in a r and omized controlled trial of resistance exercise training ( RET ) in prostate cancer survivors receiving and rogen deprivation therapy . STUDY DESIGN AND SETTING A r and omized controlled trial conducted at fitness centers in Ottawa and Edmonton , Canada . Prostate cancer survivors ( n=155 ) completed measures of social cognitive variables , quality of life ( QOL ) , behavior , and fitness before being r and omized to either an exercise ( n=82 ) or control ( n=73 ) group . The exercise group was asked to perform supervised RET three times per week for 12 weeks . RESULTS The exercise group attended 28.2 of the 36 ( 78.3 % ) RET sessions . Univariate analyses revealed eight different significant ( Ps exercise adherence including exercise stage of change , intention , age , QOL , fatigue , subjective norm , leg-press test , and perceived behavioral control . A multivariate analysis indicated that there were three independent predictors of adherence that explained 20.4 % of the variance : exercise stage of change ( beta=0.26 ; P=.013 ) , age ( beta=-0.22 ; P=.037 ) , and intention ( beta=0.19 ; P=.073 ) . CONCLUSION Exercise adherence in the trial was very good but not optimal . Adherence was predicted by variables from many different categories including social cognitive , QOL , behavioral , fitness , and demographic . These findings may have important implication s for maximizing adherence during clinical trials of exercise in prostate cancer survivors",
"During radiation therapy , cancer patients may report cancer-related fatigue ( CRF ) , which impairs aerobic capacity , strength , muscle mass , and , ultimately , quality of life ( QOL ) . The purpose of this pilot clinical trial was to examine the feasibility and initial efficacy of a home-based aerobic and progressive resistance exercise intervention for aerobic capacity , strength , muscle mass , CRF , and QOL . Daily steps walked ( DSW ) , daily minutes of resistance exercise ( MRE ) , and number of resistance exercise days ( RED ) were assessed to evaluate intervention adherence . Breast and prostate cancer patients ( n = 38 ) beginning radiation therapy were r and omized to undergo 4 weeks of exercise or no exercise . Participants in the exercise group demonstrated good adherence to the exercise intervention , with significantly more DSW , MRE , and RED at post intervention and 3 month follow-up than controls . Participants in the exercise intervention exhibited significantly higher QOL and significantly lower CRF post intervention and at 3-month follow-up than controls . Results of this pilot study provide positive preliminary evidence that exercise during radiation may be beneficial for cancer patients",
"BACKGROUND Physical exercise can improve cancer patients ' functioning and reduce their symptom levels . A r and omized , controlled trial was launched to test the hypothesis that physical exercise reduces fatigue and improves physical performance in cancer patients with advanced and incurable disease . METHODS Cancer patients ( n = 231 ) with a life expectancy ≤2 years were r and omized to a physical exercise group ( PEG , n = 121 ) or a control usual care group ( UCG , n = 110 ) . The PEG exercised under supervision 60 minutes twice a week for 8 weeks . Assessment s were performed before and after the intervention . The primary outcome was physical fatigue ( PF ) measured by the Fatigue Question naire . Physical performance was a secondary outcome measured by the Shuttle Walk Test ( SWT ) and h and grip strength ( HGS ) test . Analyses were performed after multiple imputations for missing data . The trial is registered with Clinical Trials.gov ( identifier , NCT00397774 ) . FINDINGS Thirty-six percent of the PEG were lost to follow-up compared with 23 % of the UCG , primarily as a result of disease progression . Seventy-eight PEG and 85 UCG patients completed the intervention . Analyses showed no significant between-group effects in PF . However , clinical ly and statistically significant between-group effects were found for the SWT and HGS test . INTERPRETATION Fatigue was not reduced but physical performance ( SWT and HGS test ) was significantly improved after 8 weeks of physical exercise . Physical exercise might therefore be a suitable approach for maintaining physical capacity in cancer patients with incurable and advanced disease",
"PURPOSE / OBJECTIVES To examine the effects of a seated exercise program on fatigue and quality of life ( QOL ) in women with metastatic breast cancer . DESIGN R and omized , controlled , longitudinal trial . SETTING Outpatient clinic of a comprehensive cancer center . SAMPLE Convenience sample of 38 women who were beginning outpatient chemotherapy . METHODS Subjects were r and omized to a control or intervention group ; the intervention was performance of a seated exercise program using home videotape three times per week for four cycles of chemotherapy . All subjects completed the Functional Assessment of Chronic Illness Therapy Fatigue Version IV ( FACIT F ) at baseline and at the time of the next three cycles . Subjects were asked to document the frequency , duration , and intensity of all exercise participation on monthly calendars . MAIN RESEARCH VARIABLES Exercise , fatigue , and QOL . FINDINGS 32 subjects , 16 per group , completed the study follow-up . With a mixed modeling approach , total FACIT F scores for the entire sample declined at a significant rate ( p = 0.003 ) beginning with cycle 3 but at a slower rate for the experimental group ( p = 0.02 ) . Fatigue scores indicated less increase and physical well-being subscale scores showed less decline for the experimental group ( p = 0.008 and p = 0.02 , respectively ) . CONCLUSIONS Women with advanced breast cancer r and omized to the seated exercise intervention had a slower decline in total and physical well-being and less increase in fatigue scores starting with the third cycle of chemotherapy . IMPLICATION S FOR NURSING Seated exercise may be a feasible exercise program for women with advanced cancer for controlling fatigue and improving physical well-being",
"PURPOSE Chronic inflammation is believed to contribute to the development and progression of breast cancer . Systemic C-reactive protein ( CRP ) and serum amyloid A ( SAA ) are measures of low- grade chronic inflammation and potential predictors of cancer survival . PATIENTS AND METHODS We evaluated the relationship between circulating markers of inflammation and breast cancer survival using data from the Health , Eating , Activity , and Lifestyle ( HEAL ) Study ( a multiethnic prospect i ve cohort study of women diagnosed with stage 0 to IIIA breast cancer ) . Circulating concentrations of CRP and SAA were measured approximately 31 months after diagnosis and tested for associations with disease-free survival ( approximately 4.1 years of follow-up ) and overall survival ( approximately 6.9 years of follow-up ) in 734 disease-free breast cancer survivors . Cox proportional hazards models were used with adjustment for potential confounding factors to generate hazard ratios ( HRs ) and 95 % CIs . Results Elevated SAA and CRP were associated with reduced overall survival , regardless of adjustment for age , tumor stage , race , and body mass index ( SAA P trend HRs for SAA and CRP tertiles suggested a threshold effect on survival , rather than a dose-response relationship ( highest v lowest tertile : SAA HR = 3.15 ; 95 % CI , 1.73 to 5.65 ; CRP HR = 2.27 ; 95 % CI , 1.27 to 4.08 ) . Associations were similar and still significant after adjusting for self-reported history of cardiovascular events and censoring cardiovascular disease deaths . Elevated CRP and SAA were also associated with reduced disease-free survival , although these associations were of borderline significance ( SAA P trend = .04 ; CRP P trend = .07 ) . CONCLUSION Circulating SAA and CRP may be important prognostic markers for long-term survival in breast cancer patients , independent of race , tumor stage , and body mass index",
"PURPOSE Regular physical activity reduces the risk of developing colon cancer , however , its influence on patients with established disease is unknown . PATIENTS AND METHODS We conducted a prospect i ve observational study of 832 patients with stage III colon cancer enrolled in a r and omized adjuvant chemotherapy trial . Patients reported on various recreational physical activities approximately 6 months after completion of therapy and were observed for recurrence or death . To minimize bias by occult recurrence , we excluded patients who experienced recurrence or died within 90 days of their physical activity assessment . RESULTS Compared with patients engaged in less than three metabolic equivalent task ( MET ) -hours per week of physical activity , the adjusted hazard ratio for disease-free survival was 0.51 ( 95 % CI , 0.26 to 0.97 ) for 18 to 26.9 MET-hours per week and 0.55 ( 95 % CI , 0.33 to 0.91 ) for 27 or more MET-hours per week . The adjusted P for trend was .01 . Postdiagnosis activity was associated with similar improvements in recurrence-free survival ( P for trend = .03 ) and overall survival ( P for trend = .01 ) . The benefit associated with physical activity was not significantly modified by sex , body mass index , number of positive lymph nodes , age , baseline performance status , or chemotherapy received . Moreover , the benefit remained unchanged even after excluding participants who developed cancer recurrence or died within 6 months of activity assessment . CONCLUSION Beyond surgical resection and postoperative adjuvant chemotherapy for stage III colon cancer , for patients who survive and are recurrence free approximately 6 months after adjuvant chemotherapy , physical activity appears to reduce the risk of cancer recurrence and mortality",
"CONTEXT Testicular germ cell cancer ( GCC ) patients treated with cisplatin-etoposide-bleomycin chemotherapy ( BEP ) have excellent prognosis but have an increased risk of late-occurring morbidities , which may be associated with changes in the inflammatory profile . OBJECTIVE The objective of the study was to explore plasma cytokine concentrations in GCC patients r and omized to resistance training or usual care during BEP , in comparison with healthy controls . DESIGN / SETTING This was a r and omized controlled trial in GCC patients enrolled from an oncology clinic , including a healthy reference group for comparison purpose s. OUTCOME MEASURES Plasma granulocyte macrophage colony-stimulating factor , interferon-γ , IL-1β , IL-2 , IL-6 , IL-8 , IL-10 , IL-12 , and TNF-α were measured in fasting blood sample s from GCC patients r and omized to resistance training ( INT ; n = 15 ) or usual care ( CON ; n = 15 ) and healthy age-matched controls ( REF ; n = 19 ) . Clinical toxicity assessment s and patient-reported end points were also recorded . RESULTS CON and INT were balanced at baseline . Compared with REF , CON had higher concentrations of IL-10 , IL-6 , and interferon-γ , and INT had higher concentrations of IL-6 , IL-8 and TNF-α ( all P , concentrations of IL-6 , IL-8 , and IL-10 increased in both GCC groups ( all P all cytokine concentrations were comparable with the pretreatment levels in both GCC-groups but remained elevated compared with REF ( P Changes in TNF-α correlated with pulmonary toxicity ( P , IL-6 concentrations correlated with quality of life ( P and fatigue ( P GCC patients treated with BEP display consistently elevated levels of systemic inflammatory markers compared with healthy controls . Resistance training during therapy has no impact on plasma cytokine concentrations",
"CONTEXT Exercise benefits patients with cancer , but studies of home-based approaches , particularly among those with Stage IV disease , remain small and exploratory . OBJECTIVES To conduct an adequately powered trial of a home-based exercise intervention that can be facilely integrated into established delivery and reimbursement structures . METHODS Sixty-six adults with Stage IV lung or colorectal cancer were r and omized , in an eight-week trial , to usual care or incremental walking and home-based strength training . The exercising participants were instructed during a single physiotherapy visit and subsequently exercised four days or more per week ; training and step-count goals were advanced during bimonthly telephone calls . The primary outcome measure was mobility assessed with the Ambulatory Post Acute Care Basic Mobility Short Form . Secondary outcomes included ratings of pain and sleep quality as well as the ability to perform daily activities ( Ambulatory Post Acute Care Daily Activities Short Form ) , quality of life ( Functional Assessment of Cancer Therapy-General ) , and fatigue ( Functional Assessment of Cancer Therapy-Fatigue ) . RESULTS Three participants dropped out and seven died ( five in the intervention and two in the control group , P=0.28 ) . At Week 8 , the intervention group reported improved mobility ( P=0.01 ) , fatigue ( P=0.02 ) , and sleep quality ( P=0.05 ) compared with the usual care group , but did not differ on the other measures . CONCLUSION A home-based exercise program seems capable of improving the mobility , fatigue , and sleep quality of patients with Stage IV lung and colorectal cancer",
"Health-related quality of life ( HRQOL ) in leukemia and lymphoma patients treated with high-dose chemotherapy followed by allogeneic ( SCT ) and autologous ( ASCT ) stem cell transplantation or receiving combination chemotherapy ( CT ) was prospect ively assessed by the EORTC QLQ-C30 and compared with reference data from a general population sample . One year after transplant , the SCT group had functional scores which were close to population values except for lower social ( P symptoms and problems were reported , especially appetite loss ( P = 0.001 ) and financial difficulties ( P = 0.0001 ) . The ASCT patients reported a less than optimal HRQOL relative to the population 1 year post transplant . Cognitive , physical , role , and social function , dyspnoea , financial difficulties and global quality of life were most impaired ( P physical , role and social function , dyspnoea and financial difficulties were impaired 1 year after start of chemotherapy , compared with the general population ( P qlq-c30 was supplemented by a high-dose chemotherapy module , the hdc-19 , at the 1-year assessment , but no consistent differences were found across groups . fifteen to 34 % of the patients expressed fears of relapse and worries about future health , while 24–30 % indicated no participation in sexual activities",
"PURPOSE To evaluate the effectiveness of a supervised home-based flexible training program on cardiorespiratory fitness ( CRF ) , mental distress , and health-related quality of life ( HRQOL ) parameters in young and middle-aged cancer patients shortly after curative chemotherapy . PATIENTS AND METHODS One hundred eleven patients age 18 to 50 years who had received chemotherapy for lymphomas or breast , gynecologic , or testicular cancer completed the trial . These patients were r and omly allocated to either an intervention group ( n = 59 ) , which underwent a 14-week training program , or a control group ( n = 52 ) that received st and ard care . Primary outcome was change in CRF , as determined by Astr and -Rhyming indirect bicycle ergometer test ( maximum oxygen uptake [ VO(2max ) ] ) , between baseline ( T0 ) and follow-up ( T1 ) . Secondary outcomes were mental distress , as assessed by the Hospital Anxiety and Depression Scale , and HRQOL , as assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Question naire . Two-way analysis of covariance was used to analyze changes from T0 to T1 . RESULTS VO(2max ) increased by 6.4 mL/kg(-1)/min(-1 ) in patients in the intervention group and by 3.1 mL/kg(-1)/min(-1 ) in patients in the control group ( P fatigue score decreased by 17.0 points in the control group compared with only 5.8 points in the intervention group ( P mental distress or HRQOL . CONCLUSION A supervised , home-based , flexible training program has significant effect on CRF in young and middle-aged cancer patients shortly after curative chemotherapy , but it has no favorable effect on patients ' experience of fatigue , mental distress , or HRQOL",
"Study objectives . Cancer-related fatigue is a significant and distressing problem for the cancer patient , affecting their physical and psychosocial function negatively , and reducing their quality of life . The aims of this study were to assess frequency , severity , and the consequence of fatigue in cancer out patients receiving cytotoxic drugs , using an existing international fatigue scale applied for Swedish use . Methods . The study used a non-r and omized , prospect i ve design to evaluate fatigue and its impact on quality of life in out patients receiving cytotoxic drugs . Once a week , 147 cancer patients , in an outpatient ward for cytotoxic drug administration , filled out question naires containing 13 items from the Fatigue Symptom Inventory ( FSI ) , and five additional questions . Results . Prevalence of fatigue was 92 % in the week after all patients had received cytotoxic drugs , and patients were statistically significantly more fatigued during than before treatment . The degree of fatigue was highest the week after treatment , and declined over the following week . Other symptoms , especially depressed mood , showed a strong correlation with cancer and cytotoxic-induced fatigue . Lung and breast cancer patients experienced the highest degree of fatigue . Some cytotoxic drug regimens were , apart from the underlying disease , associated with high fatigue scores , eg , those with cyclophosphamide or gemcitabine . Patients not receiving first line treatment scored significantly higher fatigue with more influence on daily living . Conclusion . The study verified that fatigue is a common side effect , and affects quality of life negatively , even for out patients receiving cytotoxic drugs . The clinical oncology pharmacist must inform patients that a severe tiredness , fatigue , may follow cytotoxic drug administration",
"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 .",
"The objective of this study was to determine the effects of exercise training on changes in C-reactive protein ( CRP ) and other cardiovascular risk factors in postmenopausal breast cancer survivors . Fifty-three postmenopausal breast cancer survivors were r and omly assigned to an exercise ( n = 25 ) or control group ( n = 28 ) . The exercise group trained on cycle ergometers 3 times per week for 15 weeks . The control group did not train . The primary end point was change in CRP between baseline and week 15 . Secondary end points were changes in RHR , HRR , SBP , DBP , TC , LDL-C , HDL-C , TG , and TC : HDL-C ratio . Fifty-two participants completed the trial . Baseline values did not differ between groups except that TG ( p = .007 ) and TC : HDL-C ratio ( p = .023 ) were higher in the exercise group . Intention-to-treat analysis showed that CRP decreased by 1.39 mg/L in the exercise group whereas it increased by 0.10 mg/L in the control group ( mean between group change , -1.49 mg/L ; 95 % CI , -3.09 to 0.10 mg/L ; p = .066 ) . Intention-to-treat analysis also showed a clinical ly and statistically significant difference between groups for change in HRR ( mean change , + 10.6 beats/min ; 95 % CI , + 3.4 to + 17.7 beats/min ; p = .004 ) and clinical ly but not statistically significant differences between groups for change in RHR ( mean change , -5.5 beats/min ; 95 % CI , -11.5 to + 0.5 beats/min ; p = .073 ) , SBP ( mean change , -5.5 mmHg ; 95 % CI , -14.5 to + 3.4 mmHg ; p = .218 ) , DBP ( mean change,-3.6 mmHg ; 95 % CI , -9.3 to + 2.1 mmHg ; p = .214 ) , and HDL-C ( mean change , + 0.05 mmol/L ; 95 % CI , -0.03 to 0.14 mmol/L ; p = .214 ) . These data suggest that exercise training may have beneficial effects on CRP and other cardiovascular risk factors in postmenopausal breast cancer survivors . Larger r and omized controlled trials are warranted",
"BACKGROUND Exercise improves physical functioning and symptom management during breast cancer chemotherapy , but the effects of different doses and types of exercise are unknown . METHODS A multicenter trial in Canada r and omized 301 breast cancer patients to thrice-weekly supervised exercise during chemotherapy consisting of either a st and ard dose of 25 to 30 minutes of aerobic exercise ( STAN ; n = 96 ) , a higher dose of 50 to 60 minutes of aerobic exercise ( HIGH ; n = 101 ) , or a combined dose of 50 to 60 minutes of aerobic and resistance exercise ( COMB ; n = 104 ) . The primary endpoint was physical functioning assessed by the Medical Outcomes Survey-Short Form (SF)-36 . Secondary endpoints were other physical functioning scales , symptoms , fitness , and chemotherapy completion . All statistical tests were linear mixed model analyses , and the P values were two-sided . RESULTS Follow-up assessment of patient-reported outcomes was 99.0 % . Adjusted linear mixed-model analyses showed that neither HIGH ( + 0.8 ; 95 % confidence interval [ CI ] = -0.8 to 2.4 ; P = .30 ) nor COMB ( + 0.5 ; 95 % CI = -1.1 to 2.1 ; P = .52 ] were superior to STAN for the primary outcome . In secondary analyses not adjusted for multiple comparisons , HIGH was superior to STAN for the SF-36 physical component summary ( P = .04 ) , SF-36 bodily pain ( P = .02 ) , and endocrine symptoms ( P = .02 ) . COMB was superior to STAN for endocrine symptoms ( P = .009 ) and superior to STAN ( P muscular strength . HIGH was superior to COMB for the SF-36 bodily pain ( P = .04 ) and aerobic fitness ( P = .03 ) . No differences emerged for body composition or chemotherapy completion . CONCLUSIONS A higher volume of aerobic or combined exercise is achievable and safe during breast cancer chemotherapy and may manage declines in physical functioning and worsening symptoms better than st and ard volumes",
"Cancer patients often report impaired sleep quality . Impaired sleep quality may be due to increased levels of sleep-mediating cytokines result ing from cancer treatment . Exercise may have a positive influence on sleep-mediating cytokines , such as interleukin-6 ( IL-6 ) , tumor necrosis factor-alpha ( TNF-α ) , and soluble tumor necrosis factor-alpha receptor ( sTNF-R ) , which may improve sleep quality . This two-arm pilot study compared the influence of a home-based exercise intervention with st and ard care/control on sleep quality and mediators of sleep . Breast and prostate cancer patients ( n = 38 ) beginning radiation therapy were r and omized to a 4-week exercise program or no exercise arm . Global sleep quality , subjective sleep quality , sleep latency , sleep duration , sleep efficiency , sleep disturbances , use of sleep medication , and daytime dysfunction were assessed with the Pittsburgh Sleep Quality Index . IL-6 , TNF-α , and sTNF-R were measured before and after intervention . There was a greater improvement in sleep quality in the exercise group from pre- to postintervention , although the difference was not significant . Additionally , there were associations between IL-6 and sleep efficiency and duration , suggesting that regulation of sleep-mediating cytokines by exercise may mediate improvements in sleep- quality components",
"PURPOSE Physically active individuals have a lower risk of developing colorectal cancer but the influence of exercise on cancer survival is unknown . PATIENTS AND METHODS By a prospect i ve , observational study of 573 women with stage I to III colorectal cancer , we studied colorectal cancer-specific and overall mortality according to predefined physical activity categories before and after diagnosis and by change in activity after diagnosis . To minimize bias by occult recurrences , we excluded women who died within 6 months of their postdiagnosis physical activity assessment . RESULTS Increasing levels of exercise after diagnosis of nonmetastatic colorectal cancer reduced cancer-specific mortality ( P for trend = .008 ) and overall mortality ( P for trend = .003 ) . Compared with women who engaged in less than 3 metabolic equivalent task [ MET ] -hours per week of physical activity , those engaging in at least 18 MET-hours per week had an adjusted hazard ratio for colorectal cancer-specific mortality of 0.39 ( 95 % CI , 0.18 to 0.82 ) and an adjusted hazard ratio for overall mortality of 0.43 ( 95 % CI , 0.25 to 0.74 ) . These results remained unchanged even after excluding women who died within 12 and 24 months of activity assessment . Prediagnosis physical activity was not predictive of mortality . Women who increased their activity ( when comparing prediagnosis to postdiagnosis values ) had a hazard ratio of 0.48 ( 95 % CI , 0.24 to 0.97 ) for colorectal cancer deaths and a hazard ratio of 0.51 ( 95 % CI , 0.30 to 0.85 ) for any-cause death , compared with those with no change in activity . CONCLUSION Recreational physical activity after the diagnosis of stages I to III colorectal cancer may reduce the risk of colorectal cancer-specific and overall mortality",
"PURPOSE To investigate the association between pre- and postdiagnosis physical activity ( as well as change in prediagnosis to postdiagnosis physical activity ) and mortality among women with breast cancer . PATIENTS AND METHODS This was a prospect i ve observational study of 933 women enrolled onto the Health , Eating , Activity , and Lifestyle Study who were diagnosed with local or regional breast cancer between 1995 and 1998 and observed until death or September 2004 , whichever came first . The primary outcomes measured were total deaths and breast cancer deaths . The primary exposures were physical activity in the year before and 2 years after diagnosis and the pre- to postdiagnosis change in physical activity . RESULTS Compared with inactive women , the multivariable hazard ratios ( HRs ) for total deaths for women expending at least 9 metabolic equivalent hours per week ( approximately 2 to 3 h/wk of brisk walking ) were 0.69 ( 95 % CI , 0.45 to 1.06 ; P = .045 ) for those active in the year before diagnosis and 0.33 ( 95 % CI , 0.15 to 0.73 ; P = .046 ) for those active 2 years after diagnosis . Compared with women who were inactive both before and after diagnosis , women who increased physical activity after diagnosis had a 45 % lower risk of death ( HR = 0.55 ; 95 % CI , 0.22 to 1.38 ) , and women who decreased physical activity after diagnosis had a four-fold greater risk of death ( HR = 3.95 ; 95 % CI , 1.45 to 10.50 ) . CONCLUSION Moderate-intensity physical activity after a diagnosis of breast cancer may improve prognosis",
"PURPOSE Physical activity ( PA ) has been suggested to help increase the survival of individuals with cancer . The objective of this review was to systematic ally evaluate and summarize the available evidence investigating the effect of PA on the survival of individuals with cancer . METHODS Electronic data bases ( CINAHL , EMBASE , and MEDLINE ) were systematic ally search ed for r and omized controlled trials and cohort studies . Selected studies were assessed by two independent investigators for method ological quality , using the PEDro scale . RESULTS Ten prospect i ve cohort studies met the inclusion criteria . Quality - assessment scores averaged 5/10 on the PEDro scale , with two articles obtaining a score of 6/10 . The majority of studies found that individuals participating in higher levels of physical activity had a reduced risk of cancer-related mortality . This trend was observed specifically for breast , colon , and colorectal cancers . On average , it appears that engaging in higher levels of metabolic equivalent hours per week may help to improve survival rates among individuals diagnosed with cancer . CONCLUSION Patients diagnosed with cancer demonstrated a trend toward increased survival with greater levels of PA . However , because only prospect i ve cohort studies were included in the study , the conclusions drawn should be regarded with caution",
"Exercise use among patients with cancer has been shown to have many benefits and few notable risks . The purpose of this study was to evaluate the impact of a home-based walking intervention during cancer treatment on sleep quality , emotional distress , and fatigue . Methods . A total of 138 patients with prostate ( 55.6 % ) , breast ( 32.5 % ) , and other solid tumors ( 11.9 % ) were r and omized to a home-based walking intervention or usual care . Exercise dose was assessed using a five-item subscale of the Cooper Aerobics Center Longitudinal Study Physical Activity Question naire . Primary outcomes of sleep quality , distress , and fatigue were compared between the two study arms . Results . The exercise group ( n = 68 ) reported more vigor ( p = .03 ) than control group participants ( n = 58 ) . In dose response models , greater participation in aerobic exercise was associated with 11 % less fatigue ( p vigor ( p = .001 ) , and 3 % less emotional distress ( p = .03 ) , after controlling for intervention group assignment , age , and baseline exercise and fatigue levels . Conclusion . Patients who exercised during cancer treatment experienced less emotional distress than those who were less active . Increasing exercise was also associated with less fatigue and more vigor . Home-based walking is a simple , sustainable strategy that may be helpful in improving a number of symptoms encountered by patients undergoing active treatment for cancer",
"PURPOSE Lymphoma patients commonly experience declines in physical functioning and quality of life ( QoL ) that may be reversed with exercise training . PATIENTS AND METHODS We conducted a r and omized controlled trial in Edmonton , Alberta , Canada , between 2005 and 2008 that stratified 122 lymphoma patients by major disease type and current treatment status and r and omly assigned them to usual care ( UC ; n = 62 ) or 12 weeks of supervised aerobic exercise training ( AET ; n = 60 ) . Our primary end point was patient-rated physical functioning assessed by the Trial Outcome Index-Anemia . Secondary end points were overall QoL , psychosocial functioning , cardiovascular fitness , and body composition . RESULTS Follow-up assessment for our primary end point was 96 % ( 117 of 122 ) at postintervention and 90 % ( 110 of 122 ) at 6-month follow-up . Median adherence to the supervised exercise program was 92 % . At postintervention , AET was superior to UC for patient-rated physical functioning ( mean group difference , + 9.0 ; 95 % CI , 2.0 to 16.0 ; P = .012 ) , overall QoL ( P = .021 ) , fatigue ( P = .013 ) , happiness ( P = .004 ) , depression ( P = .005 ) , general health ( P cardiovascular fitness ( P lean body mass ( P = .008 ) . Change in peak cardiovascular fitness mediated the change in patient-rated physical functioning . AET did not interfere with chemotherapy completion rate or treatment response . At 6-month follow-up , AET was still borderline or significantly superior to UC for overall QoL ( P = .054 ) , happiness ( P = .034 ) , and depression ( P = .009 ) without an increased risk of disease recurrence/progression . CONCLUSION AET significantly improved important patient-rated outcomes and objective physical functioning in lymphoma patients without interfering with medical treatments or response . Exercise training to improve cardiovascular fitness should be considered in the management of lymphoma patients",
"The European Cancer Anaemia Survey ( ECAS ) was conducted to prospect ively evaluate the prevalence , incidence and treatment of anaemia ( haemoglobin , including the relationship of mild , moderate and severe anaemia to performance status . Patients were evaluated for up to 6 months . Data ( N=15367 ) included demographics , tumour type , performance status , haemoglobin levels , cancer treatments and anaemia treatments . Prevalence of anaemia at enrollment was 39.3 % ( haemoglobin Low haemoglobin levels correlated significantly with poor performance status . Incidence of anaemia was 53.7 % ( haemoglobin Anaemia was treated in 38.9 % of patients ( epoetin , 17.4 % ; transfusion , 14.9 % ; and iron , 6.5 % ) . Mean haemoglobin to initiate anaemia treatment was 9.7 g/dL. Anaemia prevalence and incidence in cancer patients are high . Anaemia significantly correlates with poor performance status and many anaemic patients are not treated",
"A haematopoietic SCT ( HSCT ) can cause severe side effects , which may have a profound impact on a patient 's life both physically and psychologically . Some studies have shown that physical activity has positive effects for in patients after an HSCT . Therefore , the question arises whether a controlled exercise programme right from the beginning of the conditioning phase could help contribute to a patient 's physical and psychological recovery . To evaluate the different effects of specific , moderate physical activities on the physical and psychological condition of HSCT patients we performed a controlled r and omized study with 64 in patients undergoing an allogeneic or autologous HSCT . The patients were r and omly assigned to two groups . Although the training group took part in a specific programme of exercise therapy twice a day throughout the entire hospitalization phase , patients in the control group were offered the hospital 's st and ard mobilization programme . The results of this study showed significant differences in favour of the training group regarding strength , endurance , lung function and quality of life . However , further studies are needed to confirm these results",
"The purpose of this pilot study was to preliminarily examine the effects of an exercise program on the symptoms of fatigue , sleep disturbance , mood disturbance , symptom distress , and physical fitness for Thai women with breast cancer . Twenty-three eligible women were r and omly assigned to either an experimental group ( n = 11 ) or to a control group ( n = 12 ) . Data were collected and analyzed at baseline and again at 4 , 7 , and 10 weeks . At each time point , fatigue was measured at an expected high point during treatment . Participants in the exercise group demonstrated a trend toward improving the symptoms with mean score changes . Using generalized estimating equations analysis , a significant decrease in mood disturbance was found in the exercise group compared with control at 10 weeks ( β = 0.03 , P = 0.04 ) . The participants exhibited significantly longer 12-minute walk distance at 10 weeks than those in the control group ( t = 2.28 , P = 0.04 ) . These results indicate that exercise during adjuvant chemotherapy may be beneficial for Thai women with breast cancer",
"AIM The study aim ed at determining whether physical exercise training improves the quality of life ( QoL ) and physical fitness of breast cancer survivors . PATIENTS AND METHODS A total of 573 breast cancer survivors were r and omized into an exercise or a control group , 12-months after adjuvant treatments . EORTC QLQ-C30 and BR-23 question naires were used for evaluation of QoL , FACIT-F for fatigue and the Finnish modified version of Beck 's 13-item depression scale ( RBDI ) for depression . Physical fitness was assessed by a 2-km walking test , and a figure-8 running test and physical activity ( PA ) by metabolic equivalent ( MET ) hours per week ( MET-h/wk ) . RESULTS Figure-8 running time improved significantly among the patients of the intervention group compared with the controls ( p 2-km walking time , in PA , EORTC-QLQ-C30 , BR-23 , FACIT-F or BDI . However , there was a linear relationship between increased PA and improved QoL ( p=0.006 ) , irrespective of the intervention . CONCLUSION Increase in physical activity was associated with improved QoL , but no effect of the exercise intervention was observed",
"BACKGROUND As patients with pancreas and periampullary cancer ( PPC ) experience improved survival rates and longevity , the focus shifts toward living life while surviving cancer . Fatigue is the most commonly reported symptom in all cancer patients . Exercise has been found to effectively decrease fatigue levels and improve physical functioning in cancer patients . STUDY DESIGN One hundred two patients with resected PPC consented to participate in this study and were r and omized to either an intervention group ( IG ) or a usual care group ( UCG ) . Subjects completed visual analog scales , the FACIT-Fatigue Scale and the Short Form-36v2 after surgery and again 3 to 6 months after hospital discharge . RESULTS Patients in the IG and UCG were comparable with regard to demographics , comorbidities , cancer type and staging , type of resection , preoperative fatigue and pain levels , adjuvant therapy , and baseline walking distance . Patients in the IG had significantly improved scores on the FACIT-Fatigue Scale at study completion , improved fatigue and pain scores , as well as overall physical functioning and mental health composite scores . At study completion , participants in the IG were walking twice as far and were significantly more likely to have continued walking or another form of exercise as compared with the UCG . Using hierarchical cluster analysis , 3 mutually exclusive symptom groupings were identified in the cohort . Kaplan-Meier survival analysis did not indicate an overall survival benefit for the IG . CONCLUSIONS This is the first prospect i ve , r and omized controlled trial to report that participation in a home walking program confers a significant benefit in resected PPC patients with regard to fatigue levels , physical functioning , and health-related quality of life",
"Fatigue is a common and often severe problem in cancer patients undergoing chemotherapy . The authors postulated that physical activity training can reduce the intensity of fatigue in this group of patients",
"Fatigue is the most prevalent and debilitating symptom experienced by breast cancer patients receiving adjuvant chemotherapy or radiation therapy and few evidence -based treatments are available to manage this distressing side-effect . The purpose of this multi-institutional r and omized controlled trial was to determine the effects of exercise on fatigue levels during treatment for breast cancer . Sedentary women ( N=119 ) with Stage 0-III breast cancer receiving outpatient adjuvant chemotherapy or radiation therapy were r and omized to a home-based moderate-intensity walking exercise program or to usual care for the duration of their cancer treatment . Of participants r and omized to exercise , 72 % adhered to the exercise prescription ; 61 % of the usual care group adhered . The intention-to-treat analysis revealed no group differences in part because of a dilution of treatment effect as 39 % of the usual care group exercised and 28 % of the exercise group did not . When exercise participation was considered using the data analysis method of instrumental variables with principal stratification , a clinical ly important and statistically significant ( p=0.03 ) effect of exercise on pretest-to-posttest change in fatigue levels was demonstrated . Adherence to a home-based moderate-intensity walking exercise program may effectively mitigate the high levels of fatigue prevalent during cancer treatment",
"Before , during , and after allogeneic hematopoietic stem cell transplantation ( allo-HSCT ) , patients experience considerable physical and psychologic distress . Besides graft-versus-host disease and infections , reduced physical performance and high levels of fatigue affect patients ' quality of life . This multicenter r and omized controlled trial examined the effects of a partly self-administered exercise intervention before , during , and after allo-HSCT on these side effects . After r and omization to an exercise and a social contact control group 105 patients trained in a home-based setting before hospital admission , during inpatient treatment and a 6- to 8-week period after discharge . Fatigue , physical performance , quality of life , and physical/psychologic distress were measured by st and ardized instruments at baseline , admission to , and discharge from hospital and 6 to 8 weeks after discharge . The exercise group showed significantly improvement in fatigue scores ( up to 15 % improvement in exercise group vs up to 28 % deterioration in control ; P physical fitness/functioning ( P=.02-.03 ) and global distress ( P=.03 ) . All effects were at least detectable at one assessment time point after hospitalization or repeatedly . Physical fitness correlated significantly with all reported symptoms/variables . In conclusion , this partly supervised exercise intervention is beneficial for patients undergoing allo-HSCT . Because of low personnel requirements , it might be valuable to integrate such a program into st and ard medical care",
"PURPOSE Radiotherapy for prostate cancer ( PCa ) may cause unfavorable changes in fatigue , quality of life ( QOL ) , and physical fitness . We report results from the Prostate Cancer Radiotherapy and Exercise Versus Normal Treatment study examining the effects of 24 weeks of resistance or aerobic training versus usual care on fatigue , QOL , physical fitness , body composition , prostate-specific antigen , testosterone , hemoglobin , and lipid levels in men with PCa receiving radiotherapy . PATIENTS AND METHODS Between 2003 and 2006 , we conducted a r and omized controlled trial in Ottawa , Canada , where 121 PCa patients initiating radiotherapy with or without and rogen deprivation therapy were r and omly assigned to usual care ( n = 41 ) , resistance ( n = 40 ) , or aerobic exercise ( n = 40 ) for 24 weeks . Our primary end point was fatigue assessed by the Functional Assessment of Cancer Therapy-Fatigue scale . RESULTS The follow-up assessment rate for our primary end point of fatigue was 92.6 % . Median adherence to prescribed exercise was 85.5 % . Mixed-model repeated measures analyses indicated both resistance ( P = .010 ) and aerobic exercise ( P = .004 ) mitigated fatigue over the short term . Resistance exercise also produced longer-term improvements ( P = .002 ) . Compared with usual care , resistance training improved QOL ( P = .015 ) , aerobic fitness ( P = .041 ) , upper- ( P lower-body ( P ( P = .036 ) , while preventing an increase in body fat ( P = .049 ) . Aerobic training also improved fitness ( P = .052 ) . One serious adverse event occurred in the group that performed aerobic exercise . CONCLUSION In the short term , both resistance and aerobic exercise mitigated fatigue in men with PCa receiving radiotherapy . Resistance exercise generated longer-term improvements and additional benefits for QOL , strength , triglycerides , and body fat",
"Abstract Background . To evaluate the safety and efficacy of moderate-to-high intensity aerobic training in breast cancer patients receiving neoadjuvant chemotherapy . Methods . Twenty patients with stage IIB – IIIC operable breast cancer were r and omly assigned to receive doxorubicin plus cyclophosphamide ( AC ) or AC in combination with aerobic training ( AC + AET ) ( n = 10/group ) for 12 weeks . The AC+ AET group performed three supervised aerobic cycle ergometry sessions per week at 60%–100 % of exercise capacity ( VO2peak ) . Safety outcomes included exercise testing as well as treatment- and exercise training-related adverse events ( AEs ) , whereas efficacy outcomes included cardiopulmonary function and patient-reported outcomes ( PROs ) as measured by a cardiopulmonary exercise test ( CPET ) and Functional Assessment of Cancer Therapy-Breast ( FACT-B ) scale . Results . Twelve non-significant ECG abnormalities and three non-life threatening events occurred during CPET procedures . One AE was reported during aerobic training . There were no significant between group differences for clinician-documented events ( e.g. pain , nausea ) or hematological parameters ( p 's > 0.05 ) . Attendance and adherence rates to aerobic training were 82 % and 66 % , respectively . Intention-to-treat analysis indicated that VO2peak increased by 2.6 ± 3.5 ml/kg/min ( + 13.3 % ) in the AC + AET group and decreased by 1.5 ± 2.2 ml/kg/min ( −8.6 % ) in the AC group ( between group difference , p = 0.001 ) . FACT-B increased 11.1 points in the AC + AET group compared to a 1.5 point decrease in the AC group ( between group difference , p = 0.685 ) . Conclusion . Moderate-to-high intensity aerobic training when conducted with one-on-one supervision is a safe adjunct therapy associated with improvements in cardiopulmonary function and select PROs during neoadjuvant chemotherapy"
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OBJECTIVE To evaluate the effect of iron supplementation on mental and motor development in children through a systematic review of r and omised controlled trials ( RCTs ) . DATA SOURCES Electronic data bases , personal files , h and search of review s , bibliographies of books , abstract s and proceedings of international conferences . REVIEW METHODS RCTs with interventions that included oral or parenteral iron supplementation , fortified formula milk or cereals were evaluated . The outcomes studied were mental and motor development scores and various individual development tests employed , including Bayley mental and psychomotor development indices and intelligence quotient . RESULTS The pooled estimate ( r and om effects model ) of mental development score st and ardised mean difference ( SMD ) was 0.30 ( 95 % confidence interval ( CI ) 0.15 to 0.46 , P anaemia and iron-deficiency anaemia were significant explanatory variables for heterogeneity . The pooled estimate of Bayley Mental Development Index ( weighted mean difference ) in younger children ( was 0.95 ( 95 % CI -0.56 to 2.46 , P=0.22 ; P=0.016 for heterogeneity ) . For intelligence quotient scores ( > or = 8 years age ) , the pooled SMD was 0.41 ( 95 % CI 0.20 to 0.62 , P iron supplementation on motor development score ( SMD 0.09 , 95 % CI -0.08 to 0.26 , P=0.28 ; P=0.028 for heterogeneity ) . CONCLUSIONS Iron supplementation improves mental development score modestly . This effect is particularly apparent for intelligence tests above 7 years of age and in initially anaemic or iron-deficient anaemic subjects . There is no convincing evidence that iron treatment has an effect on mental development in children below 27 months of age or on motor development
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"OBJECTIVE To determine whether extended oral iron therapy corrects lower developmental test scores in infants with iron-deficiency anemia . STUDY DESIGN Double-blind , controlled trial in Costa Rica involving 32 12- to 23-month-old infants with iron-deficiency anemia and 54 nonanemic control subjects . Anemic infants were treated with orally administered iron for 6 months ; half the nonanemic children were treated with iron and half with placebo . Developmental test scores and hematologic status were evaluated before treatment , after 3 months , and after 6 months . RESULTS Iron-deficient anemic infants received lower mental test scores than nonanemic infants at all three time points ( p motor test scores . More of the anemic infants were rated as unusually tearful and unhappy . Anemic infants came from families with lower maternal education and less support for child development and were less likely to be breast fed , were weaned earlier , and consumed more cow milk . CONCLUSIONS Lower mental test scores persisted in infants with iron-deficiency anemia despite extended oral iron therapy and an excellent hematologic response . Iron-deficiency anemia may serve as a marker for a variety of nutritional and family disadvantages that may adversely affect infant development",
"The effect of iron supplementation on attending behavior of 96 1-y-old infants was assessed in a double-blind , r and omized , controlled trial of iron dextran in Papua New Guinea . The treatment group received an injection of iron dextran at 2 mo ; the controls received a placebo injection . Because many children had malarial parasitemia at testing , presence of malaria was used in the analysis . A significant interaction was found between iron and malaria infection on total fixation time : iron-supplemented groups and placebo-treated parasitemic children showed significantly higher total fixation scores than did placebo-treated aparasitemic children . Blood analysis of iron status showed similar results , with lowest iron status evident in the placebo-treated aparasitemic group . There was no effect of treatment on rate of habituation or dishabituation . Supplemental iron treatment has a significant effect on attention but the direction of the effect depends on the presence of malaria infection",
"To assess the effects of iron therapy on developmental test scores in infants with iron deficiency anemia , 68 Guatemalan babies 6 to 24 months of age , with and without mild iron deficiency anemia , were tested with the Bayley Scales of Infant Development before and after one week of oral iron treatment . The two major findings of the study were developmental deficits in the anemic group prior to treatment , and lack of rapid improvement with short-term oral iron therapy . The mean pretreatment Mental Development Index of the anemic group was significantly lower than that of nonanemic infants . The anemic group 's pretreatment Psychomotor Development Index was also lower than that of the nonanemic control group . In a double-blind r and omized study , six to eight days of oral iron therapy did not reverse these deficits . Consequently , the deficits of the anemic group can not be unequivocably attributed to iron lack . However , no significant differences were found between anemic and nonanemic groups in birth histories , socioeconomic level , or general nutritional status which might otherwise explain the lower developmental test scores of the anemic babies ",
"The present study investigates the effect of iron supplementation on measures of school performance among 78 iron-deficient anemic and 41 nonanemic children in an economically deprived rural area in Central Java , Indonesia . All the subjects were treated for ancylostomiasis before iron supplementation . They were r and omly assigned to either an iron or placebo group . Hematological and behavioral measurements were obtained immediately before ( T1 ) and after ( T2 ) the iron and placebo treatments . Iron treatment for a 3-mo period result ed in substantive increases in mean Hgb , Hct , and transferrin saturation among the iron-deficient anemic children . Furthermore , changes in the iron status of iron-deficient anemic children were associated with significant changes in the school achievement test scores of iron-deficient anemic children . T2 evaluation of achievement test scores indicated that the difference between iron-treated anemic and nonanemic children was still statistically significant . However , when T1 scores were entered as a covariate , iron-deficient anemic subjects treated with iron obtained significantly higher delta achievement scores . Findings from the present study indicate that iron supplementation among iron-deficient anemic children benefits learning processes as measured by the school achievement test scores",
"The behavioral effects of iron deficiency and its treatment were evaluated in a double-blind r and omized controlled community-based study of 191 Costa Rican infants , 12 to 23 months of age , with various degrees of iron deficiency . The Bayley Scales of Infant Development were administered before and both 1 week and 3 months after IM or oral administration of iron . Appropriate placebo-treated control infants were also tested . Infants with iron deficiency anemia showed significantly lower mental and motor test scores , even after considering factors relating to birth , nutrition , family background , parental IQ , and the home environment . After 1 week , neither IM nor oral iron treatments differed from placebo treatment in effects on scores . After 3 months , lower mental and motor test scores were no longer observed among iron-deficient anemic infants whose anemia and iron deficiency were both corrected ( 36 % ) . However , significantly lower mental and motor test scores persisted among the majority of initially anemic infants ( 64 % ) who had more severe or chronic iron deficiency . Although no longer anemic , they still showed biochemical evidence of iron deficiency after 3 months of treatment . These persistent lower scores suggest either that iron therapy adequate for correcting anemia is insufficient to reverse behavioral and developmental disturbances in many infants or that certain ill effects are long-lasting , depending on the timing , severity , or chronicity of iron deficiency anemia in infancy",
"Objectives : This paper reports the effects of an energy and micronutrient supplementation on quantitative and qualitative aspects of play among poorly nourished children . At issue is whether the supplement led to a progression in complexity of play . Design : two cohorts of children were r and omly assigned to three treatments : E=1171 kJ+12 mg iron ; M=12 mg iron+209 kJ ; S=104 kJ. Supplementation was given for 6 months . Evaluations of play behavior were repeated four times . Setting : The sites were six tea plantations in Pangalengan , West Java . Subjects : The present study utilized a sub sample of 55 children recruited for the larger Pangalengan project 6 months into the study . Thirty-eight children were recruited late enough to allow for longitudinal observations . The remaining cases were used for cross sectional observations only . Inclusion criteria were : no chronic disease ; length-for-age ≤−1 st and ard deviation ( s.d . ) and weight-for-length between −1 and −2 s.d . of the median of the reference of the World Health Organization . Methods : The children were videotaped during play . These tapes were coded for eight mutually exclusive categories of activities . Four activities coded represented manipulative , relational , functional and symbolic play . Results : Treatment did not affect qualitative play . Girls that received E increased functional play but boys showed the opposite effect . Children in the S group were breastfed more during play as compared to the E group . Children in the E group waited less to begin play . Sponsorship : Nestlé Foundation . European Journal of Clinical Nutrition ( 2000 ) 54 , Suppl 2 ,",
"It has been proposed that iron deficiency in infants and children is associated with behavioral alterations . To test this hypothesis , 24 infants with iron deficiency anemia , ages 9 to 26 mos , were r and omly assigned to a treatment and control group . Bayley Scales of Infant Development were administered before the institution of treatment with intramuscular iron or placebo and the test was readministered in 5 to 8 days . Mean hemoglobin level in the 2 groups was similar . It averaged 8.6 in the controls and 8.7 gm/dl in the treatment group . The 2 groupa did not differ with respect to age , sex , racial composition , or initial Bayley scores of Mental Development Index or Physical Development Index . Infants treated with iron showed a statistically significant ( p = .01 ) increase in their scores on the Mental Development Index averaging a mean gain of 13.6 points in a mean time of 6.8 days . No changes were observed in the control group . The treated group was also found to become more alert and responsive and demonstrated improvement in tests of gross and fine motor coordination . All improvement occurred independent of significant increases in hemoglobin level . These findings support the hypothesis that iron deficiency , and not anemia , in infants produces developmental alterations and that these changes are rapidly reversible with iron therapy",
"Tested 47 first-year primary school children at a mission school in rural Zaire for cognitive ability with the Kaufman Assessment Battery for Children ( K-ABC ) adopted to the language of Kituba . Within a day of this test , each child was evaluated for blood hemoglobin ( Hgb ) level and the presence of intestinal parasites . Half of the children received an iron supplement ( 20 mg Fe ) for 30 days and those children positive for the intestinal parasites of ankylostome or ascaris were r and omly selected to receive either a vermifuge treatment or placebo . All of the children were again evaluated medically and cognitively 4 weeks after the initiation of treatment . Using discriminant analysis , performance on the Mental Processing Composite of the K-ABC 1 month after treatment in combination with increases in blood Hgb result ed in the successful classification of 74 % in terms whether a child had received both iron supplement and vermifuge treatment ( p = .007 ) . With respect to our home evaluation for each child , factors related to the nutritional and economic well-being of the home environment proved a reliable marker for Simultaneous Processing ability . However , the present findings also suggest that over the short-term , changes in blood Hgb that accompany both vermifuge and iron supplement treatment together can improve certain aspects of cognitive ability , perhaps by means of heightened attentional capacity",
"The effects of oral iron supplementation on blood iron levels and learning achievement in 130 rural Indonesian school children were assessed in this double-blind study . The children were classified into anemic and nonanemic groups according to their initial hemoglobin and transferrin saturation levels and were r and omly assigned to either iron or placebo treatment for 3 mo . Hematological , anthropometric , and learning-achievement data were collected before ( T1 ) and after ( T2 ) the treatment period and 3 mo later . The means and st and ard deviations suggest that supplementation with 10 mg ferrous sulfate per kilogram body weight per day for 3 mo result ed in an apparent improvement in anemic subjects ' hematological status and learning-achievement scores . No tests of statistical comparisons are reported",
"A double-blind clinical trial was conducted in Indonesia to assess effects of iron supplementation on performance of iron-depleted and iron-deficient anemic children in discrimination and oddity learning tasks . Half these children received elemental Fe for 8 wk ; the others received a placebo . There were significant changes from pre- to postintervention evaluations in ferritin , transferrin saturation , free erythrocyte protoporphyrin , and hemoglobin among the anemic and iron-depleted children ; no changes were observed among the placebos or any of the iron-replete children . The magnitude of hematological changes in anemic children treated with iron was small ; yet , after treatment the children 's mean ferritin , transferrin saturation , and hemoglobin values were above the cutoff points used for the definition of iron-deficiency anemia ( IDA ) . Pre- and posttreatment psychological test data show that IDA produces alterations in cognitive processes related to visual attention and concept acquisition , alterations reversed with iron treatment",
"Abstract Objective : To measure the effects of iron supplementation and anthelmintic treatment on iron status , anaemia , growth , morbidity , and development of children aged 6–59 months . Design : Double blind , placebo controlled r and omised factorial trial of iron supplementation and anthelmintic treatment . Setting : Community in Pemba Isl and , Zanzibar . Participants : 614 preschool children aged 6–59 months . Main outcome measures : Development of language and motor skills assessed by parental interview before and after treatment in age appropriate subgroups . Results : Before intervention , anaemia was prevalent and severe , and geohelminth infections were prevalent and light — Plasmodium falciparum infection was nearly universal . Iron supplementation significantly improved iron status , but not haemoglobin status . Iron supplementation improved language development by 0.8 ( 95 % confidence interval 0.2 to 1.4 ) points on the 20 point scale . Iron supplementation also improved motor development , but this effect was modified by baseline haemoglobin concentrations ( P=0.015 for interaction term ) and was apparent only in children with baseline haemoglobin concentrations iron treatment increased scores by 1.1 ( 0.1 to 2.1 ) points on the 18 point motor scale . Mebendazole significantly reduced the number and severity of infections caused by Ascaris lumbricoides and Trichuris trichiura , but not by hookworms . Mebendazole increased development scores by 0.4 ( −0.3 to 1.1 ) points on the motor scale and 0.3 ( −0.3 to 0.9 ) points on the language scale . Conclusions : Iron supplementation improved motor and language development of preschool children in rural Africa . The effects of iron on motor development were limited to children with more severe anaemia ( baseline haemoglobin concentration . Mebendazole had a positive effect on motor and language development , but this was not statistically significant . What is already known on this topic Iron is needed for development and functioning of the human brain Anaemic children show developmental delays , but it is not yet clear whether iron deficiency causes these deficits or whether iron supplementation can reverse them Helminth infections in schoolchildren are associated with cognitive deficits , but few studies have been made of helminth infection and early child development What this study adds Low doses of oral iron supplementation given daily improved language development in children aged 1–4 years in Zanzibar Iron supplementation improved motor development , but only in children with initial haemoglobin concentrations below 90 g/l The effects of routine anthelmintic treatment on motor and language milestones were positive , but non-significant , with our sample",
"In a double-blind , placebo-control prospect i ve cohort study of 196 infants from birth to 15 months of age , assessment was made at 12 months of age of the relationship between iron status and psychomotor development , the effect of a short-term ( 10-day ) trial of oral iron vs placebo , and the effect of long-term ( 3 months ) oral iron therapy . Development was assessed with the mental and psychomotor indices and the infant behavior record of the Bayley Scales of Infant Development in 39 anemic , 30 control , and 127 nonanemic iron-deficient children . Anemic infants had significantly lower Mental and Psychomotor Developmental Index scores than control infants or nonanemic iron-deficient infants ( one-way analysis of variance , P less than .0001 ) . Control infants and nonanemic iron-deficient infants performed comparably . No difference was noted between the effect of oral administration of iron or placebo after 10 days or after 3 months of iron therapy . Among anemic infants a hemoglobin concentration less than 10.5 g/dL and duration of anemia of greater than 3 months were correlated with significantly lower motor and mental scores ( P less than .05 ) . Anemic infants failed specifically in language capabilities and body balance-coordination skills when compared with controls . These results , in a design in which intervening variables were closely controlled , suggest that when iron deficiency progresses to anemia , but not before , adverse influences in the performance of developmental tests appear and persist for at least 3 months despite correction of anemia with iron therapy . If these impairments prove to be long st and ing , prevention of iron deficiency anemia in early infancy becomes the only way to avoid them",
"AIMS Iron deficiency anaemia is associated , in observational studies , with developmental disadvantage . This study tested the hypothesis that feeding iron supplemented formula from 9 to 18 months of age would improve developmental performance . SUBJECTS AND METHODS 493 healthy children aged 9 months being fed pasteurised cows ’ milk were recruited from three UK centres . They were r and omised to : cows ’ milk as before , formula containing 0.9 mg/litre iron , or formula containing 1.2 mg/litre iron , until 18 months of age . Bayley mental and psychomotor developmental indices were measured at 18 months , as were growth and haematological indices . RESULTS Children fed iron fortified formula had higher plasma ferritin concentrations , but there were no significant intergroup differences in development or growth . CONCLUSIONS There are no developmental or growth advantages in children given iron supplemented formula , but a benefit for a minority who were anaemic , or the possibility that a benefit may emerge at a later age , can not be excluded",
"Eighteen- to 60-month-old iron-deficient anemic children given iron therapy ( n = 25 ) and a control group matched for mother 's educational level showed no significant difference in mean mental development score at baseline . The control group 's mean score was increased significantly over baseline score at 3 and 6 months and was significantly higher than the experimental group 's mean score at 3 months . Although the experimental group demonstrated hematologic correction over 6 months , mean mental development score showed no significant improvement . Scores for an iron deficient not anemic group given iron ( n = 22 ) , despite complete hematologic correction over the six months of observation , and for its control group , did not change significantly . Baseline scores for an iron-deficient not anemic placebo group ( n = 23 ) and for its control group were not significantly different . At 3 months the control group score had increased significantly , whereas that for the experimental group had not . When experimental and control subjects were matched on baseline mental development score , the control subjects experienced increases in scores over time , further confirming an impaired ability to improve scores with repeated testing in the experimental groups . Behavioral rating data ( responsiveness to examiner , responsiveness to environment , and emotional tone ) revealed significant differences between the iron-deficient anemic group and its control group at 3 and 6 months , with the control group rated more responsive , suggesting that iron deficiency , alone or in association with anemia , may have some lasting effect on behavior and development . Group differences were also found between the mean number of occurrences of multiple stressful events . Failure to show improvement in scores in the iron-deficient anemic group may reflect the fact that those children were less testable than were children in the control group , despite repeated testings , a theory supported by the infant behavior rating data . This may be related to some irreversible behavioral deficit or to an adverse environmental milieu ( e.g. , stress )",
"Objectives : This paper presents the results of a structural equation model testing whether the longitudinal data of the Pangalengan subjects fit the theoretical model regarding the intellectual delay of undernourished children . Design : Two cohorts of children were r and omly assigned to three treatments : E=1171 kJ+12 mg iron ; M=12 mg iron+209 kJ ; S=104 kJ. Supplementation was given for 6 months . Setting : The sites were six tea plantations in Indonesia . Subjects : A 12-month-old ( n=53 ) and an 18-month-old ( n=83 ) cohort were recruited from day-care-centers . Inclusion criteria were : no chronic disease ; length-for-age= the reference of the World Health Organization . Methods : Twenty-four-hour dietary intakes were assessed using the weighted individual inventory technique . Body weight and length were obtained using st and ard procedures ; motor development was assessed with the Bayley Scale and with a custom made scale for motor development leading to bipedal locomotion . Four-hour observations were made of the child ’s interactions with the environment . Carrying a child in the arms and exploratory behavior were used as indicators of caregiving and exploration . All measurements were obtained every 2 months . Results : The original model did not fit the data . The model was then modified with the inclusion of two new pathways : from activity and from motor development to mental development . Following these adjustments the model fit the data for each cohort and for both cohorts combined . Sponsorship : Nestlé Foundation . European Journal of Clinical Nutrition ( 2000 ) 54 , Suppl 2 ,",
"Four studies examined impacts of iron supplementation on school children of various ages and both sexes . The first study investigated impact of iron-folic acid supplements for 60 d on cognition in 94 boys and girls aged 5 - 8 y. Improvement in total scores of the anemics was significantly higher than the nonanemics in 7 - 8-y-old children only . The second study assessed impacts of supplementation on cognition in 14 pairs of 5 - 6-y-old anemic boys , with clear beneficial effects on cognitive function . The third study investigated effects of varying dosages of elemental iron on cognitive function in 48 boys aged 8 - 15 y , with different levels of improvement . The fourth study investigated impacts of iron supplementation on 163 anemic girls aged 8 - 15 y with treatment and evaluations at 4 and 8 mo , with significantly improved scores in cognitive function after the eighth month",
"OBJECTIVE To determine the efficacy of iron-fortified infant formula in preventing developmental delays and abnormal behavior . DESIGN Double-blind , r and omized , controlled trial . SETTING Urban hospital clinic . PARTICIPANTS A total of 283 healthy , bottle-fed infants from very low income families . Children with prematurity , low birth weight , and major anomalies and those who had received more than 2 weeks of evaporated-milk feedings were excluded . The groups were similar for sociodemographic background variables . Fifty-eight infants ( 20.5 % ) dropped out before any outcome data were gathered ; 225 , 204 , 186 , and 154 remained at 6- , 9- , 12- , and 15-month assessment s , respectively . INTERVENTION Iron-fortified formula ( 12.8 mg iron per liter ) versus regular formula ( 1.1 mg iron per liter ) . MAIN OUTCOME MEASURES Iron status was measured on venous blood by determination of hemoglobin , serum iron and iron-binding capacity , serum ferritin , and free erythrocyte protoporphyrin values . The Bayley Scales of Infant Development ( mental and psychomotor indexes ) and two factors of the Infant Behavior Record ( test affect and task orientation ) were the outcomes of interest . RESULTS All measures of iron status were significantly different between groups ( p Psychomotor development patterns differed between groups ( F3,520 , 3.4 ; p = 0.02 ) with time . Mean values were similar at 6 months but differed at 9 and 12 months of age ( p Mental development and behavior were not affected . CONCLUSIONS Iron-fortified formula significantly reduced iron deficiency in a high-risk group of infants and prevented a decline in psychomotor development quotients . This effect may be transient , and its long-term significance needs further study",
"This double-blind clinical trial was conducted in Thail and to assess the impact of iron treatment on the IQ and educational attainment of 1358 9 - 11-y-old children . The children were classified into one of three groups : iron replete , iron depleted , and iron-deficient anemic . The Raven Progressive Matrices was used to measure IQ . A Thai language and a math test were administered to assess school attainment . A 50-mg/d tablet of ferrous sulphate was given for 2 wk and a 100 mg/d tablet , for 14 wk . An anthelminthic drug was given on the day of the blood test before treatment and 3 mo after the intervention started . There is evidence of a positive association between iron status and IQ and a language school achievement test but there is no support for the internal validity of the hypothesis that this association is causal",
"BACKGROUND Up to 25 % of adolescent girls in the USA are iron deficient . This double-blind , placebo-controlled clinical trial assessed the effects of iron supplementation on cognitive function in adolescent girls with non-anaemic iron deficiency . METHODS 716 girls who enrolled at four Baltimore high schools were screened for non-anaemic iron deficiency ( serum ferritin Participants were r and omly assigned oral ferrous sulphate ( 650 mg twice daily ) or placebo for 8 weeks . The effect of iron treatment was assessed by question naires and haematological and cognitive tests , which were done before treatment started and repeated after the intervention . We used four tests of attention and memory to measure cognitive functioning . Intention-to-treat and per- protocol analyses were done . FINDINGS Of the 81 enrolled girls with non-anaemic iron deficiency , 78 ( 96 % ) completed the study ( 39 in each group ) . Five girls ( three control , two treatment ) developed anaemia during the intervention and were excluded from the analyses . Thus , 73 girls were included in the per- protocol analysis . Ethnic distribution , mean age , serum ferritin concentrations , haemoglobin concentrations , and cognitive test scores of the groups did not differ significantly at baseline . Postintervention haematological measures of iron status were significantly improved in the treatment group ( serum ferritin 27.3 vs 12.1 micrograms/L , p iron performed better on a test of verbal learning and memory than girls in the control group ( p this urban population of non-anaemic iron-deficient adolescent girls , iron supplementation improved verbal learning and memory"
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41181332-06ff-11f0-808a-c43d1ab1c353
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To estimate the associations between vitamin D status and multiple sclerosis ( MS ) . We search ed electronic data bases of the human literature in PubMed , EMBASE and the Cochrane Library up to February , 2014 using the following keywords : ' vitamin D ' or ' 25(OH)D ' and ' status ' or ' deficiency ' or ' insufficiency ' and ' multiple sclerosis ' . A systematic review and meta- analysis were conducted on observational studies that reported the association between blood vitamin D levels and MS . Eleven studies met the inclusion criteria . 1007 patients and 829 controls were included . Results of our meta- analysis show that MS patients had lower mean levels of 25-hydroxyvitamin D [ 25(OH)D ] than healthy controls ( weighted mean difference[MD ] , -14.52 , 95 % confidence interval [ CI ] , -23.83 to -5.22 ) . There were statistically significant heterogeneity ( P low vitamin D levels are associated with an increased risk of MS
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[
"Background Although the precise etiology of multiple sclerosis ( MS ) is unknown , it seems that both genetic and environmental factors are important . Recent studies suggest that low serum vitamin D levels are important environmental factor in MS . The aim of this study was to compare the serum levels of vitamin D between MS patients and healthy subjects , and to determine its association with disability in MS patients . Methods In this cross-sectional study , a total of 52 patients with MS were r and omly recruited and matched for age and sex with 52 healthy subjects . Demographic characteristics and serum vitamin D levels for both groups , as well as duration of disease Exp and ed Disability Status Scale ( EDSS ) for MS patients were evaluated . Statistical analysis was performed by independent sample s t-test and multiple linear regression analysis . Results The mean serum vitamin D levels were 26.5 ± 16.3 ng/ml in MS patients vs. 37.1 ±19.7 in healthy subjects ( P = 0.003 ) . A linear regression analysis showed no significant association between vitamin D levels and EDSS score of patients with MS ( P = 0.345 ) , after adjusting for the covariates . Conclusion Our findings did not suggest a protective association for serum vitamin D levels against disability in MS patients",
"CONTEXT Epidemiological and experimental evidence suggests that high levels of vitamin D , a potent immunomodulator , may decrease the risk of multiple sclerosis . There are no prospect i ve studies addressing this hypothesis . OBJECTIVE To examine whether levels of 25-hydroxyvitamin D are associated with risk of multiple sclerosis . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve , nested case-control study among more than 7 million US military personnel who have serum sample s stored in the Department of Defense Serum Repository . Multiple sclerosis cases were identified through Army and Navy physical disability data bases for 1992 through 2004 , and diagnoses were confirmed by medical record review . Each case ( n = 257 ) was matched to 2 controls by age , sex , race/ethnicity , and date s of blood collection . Vitamin D status was estimated by averaging 25-hydroxyvitamin D levels of 2 or more serum sample s collected before the date of initial multiple sclerosis symptoms . MAIN OUTCOME MEASURES Odds ratios of multiple sclerosis associated with continuous or categorical levels ( quantiles or a priori-defined categories ) of serum 25-hydroxyvitamin D within each racial/ethnic group . RESULTS Among whites ( 148 cases , 296 controls ) , the risk of multiple sclerosis significantly decreased with increasing levels of 25-hydroxyvitamin D ( odds ratio [ OR ] for a 50-nmol/L increase in 25-hydroxyvitamin D , 0.59 ; 95 % confidence interval , 0.36 - 0.97 ) . In categorical analyses using the lowest quintile ( 25-hydroxyvitamin D levels higher than 99.1 nmol/L , was significantly different from 1.00 ( OR , 0.38 ; 95 % confidence interval , 0.19 - 0.75 ; P = .006 ) . The inverse relation with multiple sclerosis risk was particularly strong for 25-hydroxyvitamin D levels measured before age 20 years . Among blacks and Hispanics ( 109 cases , 218 controls ) , who had lower 25-hydroxyvitamin D levels than whites , no significant associations between vitamin D and multiple sclerosis risk were found . CONCLUSION The results of our study suggest that high circulating levels of vitamin D are associated with a lower risk of multiple sclerosis",
"IMPORTANCE It remains unclear whether vitamin D insufficiency , which is common in individuals with multiple sclerosis ( MS ) , has an adverse effect on MS outcomes . OBJECTIVES To determine whether serum concentrations of 25-hydroxyvitamin D ( 25[OH]D ) , a marker of vitamin D status , predict disease activity and prognosis in patients with a first event suggestive of MS ( clinical ly isolated syndrome ) . DESIGN , SETTING , AND PARTICIPANTS The Betaferon/Betaseron in Newly Emerging multiple sclerosis For Initial Treatment study was a r and omized trial originally design ed to evaluate the impact of early vs delayed interferon beta-1b treatment in patients with clinical ly isolated syndrome . Serum 25(OH)D concentrations were measured at baseline and 6 , 12 , and 24 months . A total of 465 of the 468 patients r and omized had at least 1 25(OH)D measurement , and 334 patients had them at both the 6- and 12-month ( seasonally asynchronous ) measurements . Patients were followed up for 5 years clinical ly and by magnetic resonance imaging . MAIN OUTCOMES AND MEASURES New active lesions , increased T2 lesion volume , and brain volume on magnetic resonance imaging , as well as MS relapses and disability ( Exp and ed Disability Status Scale score ) . RESULTS Higher 25(OH)D levels predicted reduced MS activity and a slower rate of progression . A 50-nmol/L ( 20-ng/mL ) increment in average serum 25(OH)D levels within the first 12 months predicted a 57 % lower rate of new active lesions ( P relapse rate ( P = .03 ) , 25 % lower yearly increase in T2 lesion volume ( P loss in brain volume ( P = .07 ) from months 12 to 60 . Similar associations were found between 25(OH)D measured up to 12 months and MS activity or progression from months 24 to 60 . In analyses using dichotomous 25(OH)D levels , values greater than or equal to 50 nmol/L ( 20 ng/mL ) at up to 12 months predicted lower disability ( Exp and ed Disability Status Scale score , -0.17 ; P = .004 ) during the subsequent 4 years . CONCLUSIONS AND RELEVANCE Among patients with MS mainly treated with interferon beta-1b , low 25(OH)D levels early in the disease course are a strong risk factor for long-term MS activity and progression",
"Objective : There is increasing evidence that vitamin D can be protective against the development of multiple sclerosis ( MS ) , but it may also be beneficial for the clinical course of the disease . Our objective was to prospect ively investigate if 25-hydroxy-vitamin D ( 25-OH-D ) levels are associated with exacerbation risk in MS in a study with frequent serum measurements . Methods : This was a prospect i ve longitudinal study in 73 patients with relapsing-remitting MS . Blood sample s for 25-OH-D measurements were taken every 8 weeks . Associations between 25-OH-D levels and exacerbation rates were assessed using Poisson regression ( generalized estimating equations ) with the individual serum levels as time-dependent variable . Results : During follow-up ( mean 1.7 years ) , 58 patients experienced a total of 139 exacerbations . Monthly moving averages of 25-OH-D levels were categorized into low ( 100 nmol/L ) levels . Exacerbation risk decreased significantly with higher serum vitamin D levels : respective relative exacerbation rates for the medium and high-level category as compared to the low-level category were 0.7 and 0.5 ( p value for trend : p = 0.007 ) . The association between 25-OH-D concentrations and exacerbation rate was log linear without a threshold . With each doubling of the serum 25-OH-D concentration the exacerbation rate decreased by 27 % ( 95 % confidence interval 8%–42 % , p = 0.008 ) . Conclusions : Our finding that higher vitamin D levels are associated with decreased exacerbation risk in relapsing-remitting MS suggests a beneficial effect of vitamin D on disease course in MS . However , the possibility of reverse causality can not be ruled out completely . R and omized intervention studies are therefore needed to investigate the effect of vitamin D supplementation in MS",
"Objective : Low vitamin D status has been associated with multiple sclerosis ( MS ) prevalence and risk , but the therapeutic potential of vitamin D in established MS has not been explored . Our aim was to assess the tolerability of high-dose oral vitamin D and its impact on biochemical , immunologic , and clinical outcomes in patients with MS prospect ively . Methods : An open-label r and omized prospect i ve controlled 52-week trial matched patients with MS for demographic and disease characteristics , with r and omization to treatment or control groups . Treatment patients received escalating vitamin D doses up to 40,000 IU/day over 28 weeks to raise serum 25-hydroxyvitamin D [ 25(OH)D ] rapidly and assess tolerability , followed by 10,000 IU/day ( 12 weeks ) , and further downtitrated to 0 IU/day . Calcium ( 1,200 mg/day ) was given throughout the trial . Primary endpoints were mean change in serum calcium at each vitamin D dose and a comparison of serum calcium between groups . Secondary endpoints included 25(OH)D and other biochemical measures , immunologic biomarkers , relapse events , and Exp and ed Disability Status Scale ( EDSS ) score . Results : Forty-nine patients ( 25 treatment , 24 control ) were enrolled [ mean age 40.5 years , EDSS 1.34 , and 25(OH)D 78 nmol/L ] . All calcium-related measures within and between groups were normal . Despite a mean peak 25(OH)D of 413nmol/L , no significant adverse events occurred . Although there may have been confounding variables in clinical outcomes , treatment group patients appeared to have fewer relapse events and a persistent reduction in T-cell proliferation compared to controls . Conclusions : High-dose vitamin D ( ∼10,000 IU/day ) in multiple sclerosis is safe , with evidence of immunomodulatory effects . Classification of evidence : This trial provides Class II evidence that high-dose vitamin D use for 52 weeks in patients with multiple sclerosis does not significantly increase serum calcium levels when compared to patients not on high-dose supplementation . The trial , however , lacked statistical precision and the design requirements to adequately assess changes in clinical disease measures ( relapses and Exp and ed Disability Status Scale scores ) , providing only Class level IV evidence for these outcomes",
"The aim of this preliminary study was to evaluate the effect of low-dose oral vitamin D in combination with current disease-modifying therapy on the prevention of progression of relapsing-remitting multiple sclerosis ( RRMS ) . A phase II double-blind placebo-controlled r and omized clinical trial conducted between October 2007 and October 2008 included 50 patients with confirmed RRMS aged 25 to 57 years and normal serum 25-hydroxyvitamin D. They were r and omly allocated to receive 12 months of treatment with either escalating calcitriol doses up to 0.5 μg/day or placebo combined with disease-modifying therapy . Response to treatment was assessed at eight-week intervals . In both groups , the mean relapse rate decreased significantly ( P the mean ( SD ) Exp and ed Disability Status Scale ( EDSS ) increased from 1.70 ( 1.21 ) at baseline to 1.94 ( 1.41 ) at the end of study period ( P ) . Average EDSS and relapse rate at the end of trial did not differ between groups . Adding low-dose vitamin D to routine disease-modifying therapy had no significant effect on the EDSS score or relapse rate . A larger phase III multicenter study of vitamin D in RRMS is warranted to more assess the efficacy of this intervention"
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411813b4-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Although atrial fibrillation ( AF ) is accepted as the most common sustained cardiac arrhythmia , most published epidemiologic studies focus on predominantly white population s in North America or Europe , and information on AF in nonwhite population s is scarce . The objective of this study was to undertake a systematic review of the published literature on the epidemiology of AF in other regions . METHODS Systematic literature search es ( MEDLINE ; 1990 - 2010 ) identified epidemiologic studies reporting on the prevalence or incidence of AF , stroke in AF , risk factors for AF , or the use of antithrombotic therapy in countries outside North America and Europe . This report presents a descriptive analysis of the data ; no meta- analysis was planned . RESULTS Many of the 38 articles identified were from the Far East , although Australia , New Zeal and , the Middle East , and South America were also represented . The reported prevalence of AF varied among countries , with different ranges in community- and hospital-based studies ( 0.1%-4 % and 2.8%-14 % , respectively ) . The use of anticoagulant therapy varied widely among countries and studies , as did the reported prevalence of stroke in patients with AF ( 2.8%-24.2 % ) . CONCLUSIONS High- quality epidemiologic studies are clearly required to improve underst and ing of the worldwide burden of AF and stroke in AF . Major improvements in the provision of thromboprophylaxis are also needed in many countries , given the high proportion of untreated patients who are , hence , at risk of stroke
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"BACKGROUND There remains uncertainty about the risk of cardiovascular events in stable out patients with a history of myocardial infa rct ion ( MI ) , stroke , and atrial fibrillation in Japan . METHODS AND RESULTS In the Japan Thrombosis Registry for Atrial Fibrillation , Coronary , or Cerebrovascular Events ( J-TRACE ) , a nationwide prospect i ve cohort of stable out patients with a history of MI ( n=2,291 ) , stroke ( n=3,554 ) , and /or atrial fibrillation ( n=2,242 ) , 1-year follow-up data were available for 7,513 of 8,087 patients ( follow-up rate : 92.9 % ) . The primary endpoint ( death/MI/stroke ) was reported in 3.53 events per 100 person-years ( 95 % confidence interval [ CI ] : 3.11 - 3.99 ) within 1 year . The rates of all-cause death , death from stroke , and death from MI within 1 year were 1.35 ( 95%CI : 1.10 - 1.65 ) , 0.15 ( 95%CI : 0.08 - 0.27 ) , and 0.06 ( 95%CI : 0.02 - 0.14 ) per 100 person-years , respectively . The rate of non-fatal stroke was 1.85 ( 95%CI : 1.55 - 2.19 ) , while that of non-fatal MI was 0.33 ( 95%CI : 0.21 - 0.49 ) . The rate of non-fatal stroke was highest among stroke patients ( 2.95 ; 95%CI : 2.39 - 3.60 per 100 person-years ) , while that of non-fatal MI was similar across all disease categories . Investigator-decided serious non-fatal bleeding events occurred in 0.21 events ( 95%CI : 0.12 - 0.34 ) per 100 person-years . CONCLUSIONS In this large , nationwide Japanese registry , the highest stroke event rate was seen in patients with a history of stroke",
"BACKGROUND Although hyperuricemia has been reported to be a risk factor of stroke , the relationship between hyperuricemia and stroke in patients with atrial fibrillation ( AF ) remains uncertain . The goal of the present study was to investigate whether hyperuricemia could potentially refine clinical risk stratification in AF . METHODS This study used the \" National Health Insurance Research Data base \" in Taiwan . A total of 7601 AF patients who did not receive antiplatelet agents or oral anticoagulants were identified as the study population . Hyperuricemia was defined as having at least one episode of gout attack necessitating long-term treatment with uric acid-lowering agents . The association between hyperuricemia and ischemic stroke was analyzed . RESULTS During the follow up of 3.0±2.7 years , 1116 patients ( 14.7 % ) experienced ischemic stroke with an annual rate of around 4.9 % . Hyperuricemia significantly predicts stroke , with a hazard ratio ( HR ) of 1.280 after adjusting for CHA2DS2-VASc score and other comorbidities . Among the 376 patients with a CHA2DS2VASc score of 0 , hyperuricemia can further stratify them into 2 groups with different stroke rates ( 7.1 % versus 1.3 % , p=0.020 ) . The adjusted HR of hyperuricemia in predicting ischemic stroke diminished from 7.491 for patients with a CHA2DS2-VASc score of 0 to 1.659 for those with a score of 3 , and became insignificant for patients with a score ≥4 . CONCLUSIONS Hyperuricemia was a significant risk factor of stroke which could potentially refine the clinical risk stratification in AF . It deserves a prospect i ve trial to investigate whether it would change the current strategy for stroke preventions using oral anticoagulants ",
"A prospect i ve registry was made of all patients hospitalized with atrial fibrillation ( AF ) in the State of Qatar from 1991 to 2010 . Clinical characteristics , management , and outcomes were compared according to ethnicity ( Middle Eastern Arab vs South Asian ) . During this 20-year period , 2857 Arabs and 548 Asians were hospitalized for AF . Arabs were 9 years older and more likely to have hypertension , diabetes mellitus ( DM ) , chronic renal impairment , and dyslipidemia than the Asians . Valvular heart disease and acute coronary syndromes were more common among Asians , while congestive heart failure was more common in Arabs . The overall inhospital mortality was lower in Asians than that of Arabs , while stroke rates were comparable . There was an increase in the prevalence of DM and hypertension in both the groups in the latter years of the study period , but there was no change in mortality trends . Our findings underscore the need to study AF according to ethnicity",
"BACKGROUND Evidence regarding the relationship between different levels of alcohol consumption and the risk of atrial fibrillation ( AF ) is currently limited in Asian population s. METHODS AND RESULTS Between 1991 and 1995 , a total of 8,602 Japanese men and women aged 30 - 80 years took part in the first examination of the Circulatory Risk in Communities Study ( CIRCS ) , a population -based cohort study in Japanese communities . An interviewer obtained detailed information on weekly alcohol intake . During the follow-up period , the incidence of AF was ascertained from annual ECG records , the subject 's medical history of AF , and cardiovascular disease surveillance . The hazard ratios ( HRs ) of incident AF and the 95 % confidence intervals ( CIs ) relative to the never-drinking group were calculated with adjustment for potential confounding factors by using the Cox proportional hazard model . During a median follow-up period of 6.4 years , 296 incidents of AF occurred . A higher incidence of AF was observed among participants with an ethanol intake > 69g/day , compared with never-drinkers . Compared with the never-drinkers , the multivariable-adjusted HRs ( CIs ) of past , light ( 69g/day ) drinkers were 1.30 ( 0.68 - 2.49 ) , 0.89 ( 0.60 - 1.32 ) , 1.19 ( 0.73 - 1.95 ) , 1.36 ( 0.79 - 2.35 ) , and 2.90 ( 1.61 - 5.23 ) , respectively . CONCLUSIONS Heavy alcohol consumption is associated with a higher risk of AF",
"OBJECTIVE This study aim ed at the assessment of the clinical approach to atrial fibrillation ( AF ) in the older population and the consistency with the guidelines based on the records of the multicenter , prospect i ve AFTER ( Atrial Fibrillation in Turkey : Epidemiologic Registry ) study . PATIENTS AND METHODS 2242 consecutive patients admitted to the Cardiology Outpatient Clinics of 17 different tertiary Health Care Centers with at least one AF attack determined on electrocardiographic examination , were included in the study . Among the patients included in the study , 631 individuals aged 75 years and older were analyzed . RESULTS The mean age of the patients was determined as 80.3±4.2 years . The most frequent type of AF in geriatric population was the persistent-permanent type with a percentage of 88 % . 60 % of the patients with AF were female . Hypertension was the most common co-morbidity in patients with AF ( 76 % ) . While in 16 % of patients a history of stroke , transient ischemic attack or systemic thromboembolism was present , a history of bleeding was present in 14 % of the patients . 37 % of the patients were on warfarin treatment and 60 % of the patients were on aspirin treatment . In 38 % of the patients who were on oral anticoagulant treatment , INR level was in the effective range . CONCLUSIONS The rate of anticoagulant use in the elderly with AF was 37 % and considering the reason of this situation was the medication not being prescribed by the physician , one should pay more attention particularly in the field of treatment",
"Background & objectives : Morphological abnormalities in 12-lead electrocardiograms ( ECGs ) are seen in subgroups of healthy individuals like athletes and air-force personnel . As these population s may not truly represent healthy individuals , we assessed morphological abnormalities in ECG in healthy volunteers participating in phase I studies , who are screened to exclude associated conditions . Methods : ECGs from 62 phase I studies analyzed in a central ECG laboratory were pooled . A single drug-free baseline ECG from each subject was review ed by experienced cardiologists . ECG intervals were measured on five consecutive beats and morphological abnormalities identified using st and ard guidelines . Results : Morphological abnormalities were detected in 25.5 per cent of 3978 healthy volunteers ( 2495 males , 1483 females ; aged 18 - 76 yr ) ; the presence was higher in males ( 29.3 % vs. 19.2 % in females ; P Rhythm abnormalities were the commonest ( 11.5 % ) followed by conduction abnormalities ( 5.9 % ) , axis deviation ( 4 % ) , ST-T wave changes ( 3.1 % ) and chamber enlargement ( 1.4 % ) . Incomplete right bundle branch block ( RBBB ) , short PR interval and right ventricular hypertrophy were common in young subjects ( atrial fibrillation , first degree atrioventricular block , complete RBBB and left anterior fascicular block were more prevalent in elderly subjects ( > 65 yr ) . Prolonged PR interval , RBBB and intraventricular conduction defects were more common in males while sinus tachycardia , short PR interval and non-specific T wave changes were more frequent in females . Interpretation & Conclusions : Morphological abnormalities in ECG are commonly seen in healthy volunteers participating in phase I studies ; and vary with age and gender . Further studies are required to determine whether these abnormalities persist or if some of these disappear on follow up",
"Background Only a few population -based cohort studies have investigated the impact of atrial fibrillation ( AF ) on stroke in Japan . Methods A total of 10 929 participants ( 4147 men and 6782 women ) were included in this population -based prospect i ve cohort study . Baseline data , including electrocardiograms ( ECGs ) to ascertain AF status , were obtained from April 1992 through July 1995 in 12 areas in Japan . Cox proportional hazards models were used to analyze the association of AF with stroke . Results A total of 54 participants had AF ( 0.49 % ) . The mean follow-up period was 10.7 years , during which 405 strokes were identified ; 12 of these occurred in participants with AF . The crude incidence of stroke in participants with and without AF was 14.9 and 4.5 per 1000 person-years in men , respectively , and 39.3 and 2.7 per 1000 person-years in women . After adjusting for geographical area , sex , age , smoking status , drinking status , obesity , hypertension , dyslipidemia , and diabetes mellitus , the hazard ratios ( 95 % confidence interval ) of AF in all participants and in male and female participants were 4.11 ( 2.28–7.41 ) , 2.12 ( 0.77–5.84 ) , and 10.6 ( 5.01–22.4 ) , respectively . The population attributable fraction ( PAF ) of stroke caused by AF was 2.2 % ; the PAFs were 1.0 % and 3.6 % in men and women , respectively . Conclusions The present Japanese population -based prospect i ve cohort study showed that AF is a major risk factor for stroke , especially in women",
"OBJECTIVE To assess the risk of first-ever ischemic stroke in younger patients with atrial fibrillation ( AF ) who have none of the CHA2DS2-VASc ( congestive heart failure , hypertension , age ≥75 years , diabetes mellitus , previous stroke/transient ischemic attack , vascular disease , age 65 - 74 years , sex category [ female sex ] ) risk factors ( excluding female sex ) by using the National Health Insurance research data base in Taiwan . PATIENTS AND METHODS From 22,842,778 insured people , we identified 24,612 hospitalized patients with newly diagnosed AF between January 1 , 2002 , and December 31 , 2004 , as the AF group and r and omly selected 98,448 age- and sex-matched persons without AF as the non-AF group . Both groups were followed up until December 31 , 2010 , to estimate ischemic stroke incidences in relation to other stroke risk factors . RESULTS During a follow-up period of 89,468 person-years , the stroke rate was higher in patients with AF than in those without AF ( 5.79 per 100 person-years vs 2.25 per 100 person-years ) . The higher prevalence of CHA2DS2-VASc comorbidities ( heart failure , hypertension , diabetes , coronary artery disease , and peripheral artery disease ) in patients with AF further increased the stroke risk . In 790 patients with AF aged 30 to 55 years who had none of the CHA2DS2-VASc comorbidities at baseline and retained a \" low risk , \" that is , those with a CHA2DS2-VASc score of 0 in men and 1 in women during follow-up , the stroke rate remained considerably higher than that in their non-AF counterparts ( 1.00 per 100 person-years vs 0.25 per 100 person-years ) , with a sex-adjusted hazard ratio of 4.09 ( 95 % CI , 2.97 - 5.62 ) . CONCLUSION This study finds an increased risk of stroke in younger patients with AF who are not recommended for prevention of thromboembolism by current guidelines . Better stroke risk stratification tools are needed to prioritize younger patients with AF for thromboprophylactic therapy in this population",
"Background : Most studies on atrial fibrillation ( AF ) epidemiology , treatment , and outcomes have included mainly Caucasians patients . The world literature on AF in other ethnicities is very limited particularly in the elderly . Aims : The aim of this study was to compare the clinical characteristics , treatment and outcome of elderly and younger patients hospitalized with AF in a Middle-Eastern country and examine the trends of AF etiologies over a 20-year period . Methods : A retrospective analysis of a prospect i ve registry of all patients hospitalized with AF in Qatar from 1991 through 2010 was made . Patients were divided into three groups ; group 1 : patients ≦50 years old , group 2 : patients between 51 and 70 years old , and group 3 : patients > 70 years old . Clinical characteristics , management , and outcomes of AF patients were compared according to age . Results : Between the year 1991 and the end of 2010 , a total 3848 consecutive patients were admitted with AF . One thous and three hundred and forty-five patients were ≦50 years , 1759 were between 51 and 70 years and 744 patients were > 70 years old . Elderly patients were more likely to have hypertension and chronic renal impairment . There was a higher prevalence of associated coronary artery disease and aortic stenosis in elderly patients with a lower left ventricular ejection fraction than the younger age groups . A lower use of anticoagulation in the elderly group was observed but there was no underuse of other evidence -based medications . The older AF patients had significantly higher in-hospital mortality and stroke rates with no significant changes in mortality trends over the 20 years of study . An increasing trend of the associated acute coronary syndromes , hypertension and diabetes mellitus prevalence was observed in the elderly group . Conclusion : Anticoagulation remains underutilized in elderly patients with AF despite proven efficacy and increasing trends of cardiovascular comorbidities . The current study underscores the urgent need for prospect i ve studies to investigate warfarin contraindications , relative warfarin efficacy and bleeding risks in our region to help guide healthcare providers in warfarin prescribing in this frail patient population and consequently reduce the risk of AF-related disabling strokes and mortality ",
"BACKGROUND AND AIM Atrial fibrillation ( AF ) is an important cardiovascular disease in the elderly . The association between hyperuricemia and AF is unclear . Therefore , we aim ed to investigate the prospect i ve relationship between uric acid and development of AF in a nationally representative cohort of elderly people . METHODS AND RESULTS A total of 1485 elderly people ( age ≥ 65 yrs ) from the Elderly Nutrition and Health Survey in Taiwan ( 1999 - 2000 ) were without AF on \" electrocardiography \" at baseline . Incident AF events ( International Classification of Diseases , Ninth Revision , Clinical Modification , ICD-9-CM : 427.31 ) were identified using data from the National Health Insurance Data set . Hyperuricemia was defined as levels of uric acid > 7.0 mg/dL in men and 6.0 mg/dL in women . A Cox proportional hazards model was used to evaluate the association between hyperuricemia and incident AF . The follow-up period was from 1999 to 2000 to 2008 . During the follow-up period ( median : 9.16 yrs ) , 90 AF events occurred ( 44 in men and 46 in women ) . Older age , elevated systolic blood pressure , being an ex-smoker , and high uric acid were positively associated with incident AF . Hyperuricemia was positively associated with incident AF in normotensive ( age-adjusted hazard ratio ( HR ) : 2.65 and 95 % confidence intervals : 1.05 - 6.69 ) , but not in ( 1.20:0.74 - 1.94 ) hypertensive individuals ( systolic blood pressure ≥130 or diastolic blood pressure ≥85 or using hypertensive medicine ) . A significant association between hyperuricemia and AF ( 3.78 ; 1.24 - 11.59 ) remained after adjusting for other potential confounders among normotensive older persons . CONCLUSION Hyperuricemia is associated with the development of AF in elderly people with normal blood pressure",
"BACKGROUND Although various kinds of cardiovascular risk factors have been reported to be associated with atrial fibrillation ( AF ) , the relationship between serum uric acid level and AF has not been fully examined . METHODS AND RESULTS Data were collected from a single hospital-based cohort in the Shinken Data base 2004 - 2008 ( n=11,123 ) , and consisted of serum uric acid level for 7,155 patients . The association between serum uric acid level and AF prevalence was evaluated on logistic regression . Uric acid significantly increased the crude AF prevalence in both men and women ( both , P odds ratio ( OR ) and 95 % confidence interval ( 95%CI ) in the highest tertile compared with the lowest one were 3.368 ( 2.478 - 4.578 ) and 1.408 ( 1.169 - 1.695 ) in women and men , respectively . Uric acid was also significantly associated with other various cardiovascular risk factors for AF . Even after the multivariate model was adjusted using these variables , the effect of uric acid on AF was independent in women ( OR , 1.888 ; 95%CI : 1.278 - 2.790 ) , but not in men . CONCLUSIONS Reflecting the composite of various cardiovascular risk factors , serum uric acid level was apparently associated with AF prevalence . The independent association in women might imply some sex-specific mechanisms . The results should be confirmed in prospect i ve studies",
"BACKGROUND Tobacco smoking is a well-known risk factor for cardiovascular disease , but controversial results have been reported regarding its relationship with atrial fibrillation ( AF ) . Moreover , no study on the relationship between smoking and AF has yet been undertaken in a Japanese context . METHODS AND RESULTS We used data from the Shinken Data base 2004 - 2011 ( men/women , n=10,714/6,803 , respectively ) , which included all new patients attending the Cardiovascular Institute between June 2004 and March 2012 . AF was diagnosed in 1,698 and 598 men and women , respectively . In men , smokers were more prevalent in the AF than in the non-AF group ( 54.5 % vs. 44.7 % ) , whereas in women the prevalence of smokers was similar between AF and non-AF groups ( 14.4 % vs. 15.4 % ) . This discrepancy between the sexes seems to derive from a characteristic distribution pattern of smoking habit in women . After adjustment for various cofactors , smoking was independently associated with AF ( odds ratio 1.54 ; 95 % confidence interval 1.35 - 1.75 ; P with AF without a significant interaction between sex categories among Japanese patients visiting a cardiovascular hospital . Further studies using a prospect i ve cohort design are required to confirm a causal link between smoking and AF in Japanese patients",
"OBJECTIVE To investigate the prevalence and distributing feature of atrial fibrillation ( AF ) in Xinjiang Kazaks adult population . METHODS Four-stage selected r and om sample s aged 30 - 89 years from Tacheng , Yili and Aletai were analyzed . An epidemical study of AF was performed including inquiring medical history , recording electrocardiogram and auscultation . RESULTS A total of 22 514 adults were surveyed . The prevalence of AF in Xinjiang Kazaks adult population was 0.37 % , which was increasing with aging . The prevalence was higher in men than in women ( 0.5 % vs 0.2 % , P valvular AF . Ischemic stroke was the most frequent type and the stroke rate in the patients with AF was significantly higher than that without AF ( 6.0 % vs 1.2 % , P Xinjiang Kazaks adult population is lower than the reported national prevalence but patients with AF in this population would not like to take the necessary medicine . Therefore , the control of AF need to be reinforced",
"Background Recent evidence suggests that there are ethnic variations in atrial fi brillation ( AF ) susceptibility and incidence following acute myocardial infa rct ion ( AMI ) . Objectives The aim of this study was to evaluate the incidence and predictors of AF in the setting of AMI in Middle Eastern Arab and South Asian patients and its impact on in-hospital morbidity and mortality . Methods A retrospective analysis of a prospect i ve registry of all patients hospitalized with AMI in the state of Qatar from 1991 through 2010 was made . Clinical characteristics and outcomes of AMI patients with and without AF were compared . Sub- analysis according to ethnicity was also performed . Results During the 20-year period ; a total of 12,881 patients were hospitalized with AMI . Of these 5028 were Arabs and 5985 were South Asians . A total of 227 had AF during hospitalization with an overall incidence of 1.8 % ( 156 Arabs ; incidence 3.1 % and 48 South Asians ; incidence 0.8 % ) . The mean age of AF patients was 65 years ( Arabs 69 , South Asians 54 ) . Patients with AF were signifi cantly older and had more cardiovascular co-morbidities than patients without AF , and were more likely to have non-ST elevation AMI on presentation . Patients with AF had signifi cantly higher in-hospital mortality rate ( 20.3 % versus 7.1 % ; P= 0.001 ) and stroke rates ( 1.8 % versus 0.3 % ; P= 0.001 ) when compared to patients without AF . Age was the only independent predictor of AF development in patients with AMI in our study . Conclusions Our study reports variability in the prevalence of AF among AMI patients according to ethnicity using a 20-year registry from a Middle Eastern country . Advancing age was the major independent predictor of AF in our AMI patients . Further prospect i ve studies are required evaluating optimal therapeutic approaches for these high-risk patients in order to reduce the high mortality observed"
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Abstract Lisman , PJ , de la Motte , SJ , Gribbin , TC , Jaffin , DP , Murphy , K , and Deuster , PA . A systematic review of the association between physical fitness and musculoskeletal injury risk : part 1—cardiorespiratory endurance . J Strength Cond Res 31(6 ) : 1744–1757 , 2017—Musculoskeletal injuries ( MSK-Is ) are a significant health problem for both military and athletic population s. Research indicates that MSK-I is associated with physical fitness ; however , the association between specific components of physical fitness and MSK-I in military and athletic population s has not been systematic ally examined . Our goal was to systematic ally review the literature to provide a best evidence synthesis on the relationship between components of physical fitness and MSK-I risk in military and civilian athletic population s. This first of 3 manuscripts focuses on cardiorespiratory endurance ( CRE ) . MEDLINE , EBSCO , EMBASE , and the Defense Technical Information Center were search ed for original studies published from 1970 through 2015 that examined associations between physical fitness and MSK-I. Forty-nine of 4,229 citations met our inclusion criteria . Primary findings indicate that there is ( a ) strong evidence that poor performance on a set distance run for time is a predictor for MSK-I risk in both genders ; ( b ) strong evidence that poor performance on timed shuttle runs is a predictor for MSK-I risk in males ; ( c ) moderate evidence in males and limited evidence in females that poor performance on a timed step test is a predictor of MSK-I risk ; and ( d ) limited or insufficient evidence that poor performance on the Cooper run test , maximal and submaximal aerobic grade d exercise tests , and the Conconi test are predictors of MSK-I risk in males or females or both . Several measures of CRE are risk factors for training-related MSK-I in military and civilian athletic population s , indicating that CRE may be an important measure for MSK-I risk stratification
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" Among a population of r and omly selected US Marine Corps recruits at Marine Corps Recruit Depot , San Diego , California , the authors developed a screening tool to identify individuals at high risk for lower extremity stress fracture when beginning a rigorous physical training program . The screening tool was developed among 1,286 recruits , then tested and refined among 1,078 additional recruits . The refined algorithm , consisting of five physical activity questions and a 1.5-mi ( 2.4-km ) run time , revealed that 21.6 % of \" high risk \" subjects suffered more than three times as many stress fractures as \" low risk \" subjects . These data suggest that risk of stress fracture during rigorous physical training is increased by poor physical fitness and low levels of physical activity prior to their entry into the program",
"Background Military service in Finl and is compulsory for all male citizens and annually about 80 % of 19-year-old men enter into the service . The elevated risk for many chronic diseases and loss of function among those who are inactive and unfit can be often detected already in youth . On the other h and , activity-induced injuries among young are true public health issue . The purpose of the present prospect i ve cohort follow-up study was to evaluate predictive associations between acute or overuse injuries and their various intrinsic risk factors . Methods Four successive cohorts of conscripts who formed a representative sample of Finnish young men were followed for 6 months . At the beginning of the service , the risk factors of injuries were measured and recorded and then the acute and overuse injuries treated at the garrison clinic were identified . Predictive associations between injuries and their risk factors were examined by multivariate Cox ’s proportional hazard models . Results Of the 1411 participants , 27 % sustained an acute injury and 51 % suffered from overuse injury . Concerning acute injuries , highest risk for severe injuries were detected among conscripts with low fitness level in both the st and ing long-jump and push-up tests ( hazard rate , HR=5.9 ; 95 % CI : 1.6‒21.3 ) . A history of good degree in school sports was not a protective factor against acute injuries . High waist circumference and , on the other h and , being underweight according to BMI increased the HR for overuse injuries . Brisk leisure time physical activity before military entry was a protective factor against overuse injuries . Poor result in Cooper ’s test was a warning signal of elevated risk of overuse injuries . Conclusion We confirmed previous findings that low level of physical fitness is predictor for musculoskeletal injuries during intensive physical training . The U-shaped relationship between body composition and overuse injuries was noticed indicating that both obesity and underweight are risk factors for overuse injuries . Persons with excellent sports skills according to their earlier degrees in school sports had similar HR for acute injuries than those with poorer degrees . This indicates that school-age sports skills and fitness do not carry far and therefore preventive programmes are needed to prevent activity-induced injuries",
"PURPOSE To assess the relationships between player characteristics ( including age , playing experience , ethnicity , and physical fitness ) and in-season injury in elite Australian football . DESIGN Single-cohort , prospect i ve , longitudinal study . METHODS Player characteristics ( height , body mass , age , experience , ethnicity , playing position ) , preseason fitness ( 6-min run , 40-m sprint , 6 × 40-m sprint , vertical jump ) , and in-season injury data were collected over 4 seasons from 1 professional Australian football club . Data were analyzed for 69 players , for a total of 3879 player rounds and 174 seasons . Injury risk ( odds ratio [ OR ] ) and injury severity ( matches missed ; rate ratio [ RR ] ) were assessed using a series of multilevel univariate and multivariate hierarchical linear models . RESULTS A total of 177 injuries were recorded with 494 matches missed ( 2.8±3.3 matches/injury ) . The majority ( 87 % ) of injuries affected the lower body , with hamstring ( 20 % ) and groin/hip ( 14 % ) most prevalent . Nineteen players ( 28 % ) suffered recurrent injuries . Injury incidence was increased in players with low body mass ( OR=0.887 , P=.005 ) , with poor 6-min-run performance ( OR=0.994 , P=.051 ) , and playing as forwards ( OR=2.216 , P=.036 ) . Injury severity was increased in players with low body mass ( RR=0.892 , P=.008 ) , tall stature ( RR=1.131 , P=.002 ) , poor 6-min-run ( RR=0.990 , P=.006 ) , and slow 40-m-sprint ( RR=3.963 , P=.082 ) performance . CONCLUSIONS The potential to modify intrinsic risk factors is greatest in the preseason period , and improvements in aerobic-running fitness and increased body mass may protect against in-season injury in elite Australian football",
"BACKGROUND Stress fractures and other musculoskeletal injuries are major sources of morbidity among female military trainees . Several risk factors have been postulated , particularly pre-existing fitness , usually assessed with post-entry run time for ≥ 1.0 mile . PURPOSE Physical fitness is not formally evaluated prior to Army entry . If a valid and simple test that identified women at increased risk of stress fracture were available and could be applied prior to entry , it would facilitate cost-benefit studies of deferral or interventions . These analyses were undertaken to determine if a 5-minute step test conducted before entry identified women at increased risk . METHODS A prospect i ve study was conducted of weight-qualified women entering the Army in 2005 - 2006 , with analyses completed in 2011 . At the pre-entry examination , information was collected on age , BMI , smoking , race , and activity level . Everyone took the step test . All outpatient medical encounters were captured , and stress fractures and other musculoskeletal injuries identified . Women with stress fractures and those with other musculoskeletal injuries were evaluated separately . RESULTS 1568 women were included in the study ; 109 developed stress fractures and 803 other musculoskeletal injury . Women who failed the step test had a 76 % higher stress fracture incidence and a 35 % higher incidence of other musculoskeletal injuries . There was effect modification between age and test failure for stress fracture . CONCLUSIONS A step test that can be administered before military entry identifies women with increased incidence of stress fracture and other musculoskeletal injury . This test could be used pre-entry to defer or target high-risk recruits for tailored fitness training before or after military entrance",
"Background The injury risk in football is high , but little is known about causes of injury . Purpose To identify risk factors for football injuries using a multivariate model . Study Design Prospect i ve cohort study . Methods Participants were 306 male football players from the two highest divisions in Icel and . Before the 1999 football season started , the following factors were examined : height , weight , body composition , flexibility , leg extension power , jump height , peak O2 uptake , joint stability , and history of previous injury . Injuries and player exposure were recorded throughout the competitive season . Results Older players were at higher risk of injury in general ( odds ratio [ OR ] = 1.1 per year , P = 0.05 ) . For hamstring strains , the significant risk factors were age ( OR = 1.4 [ 1 year ] , P groin strains , the predictor risk factors were previous groin strains ( OR = 7.3 , P = 0.001 ) and decreased range of motion in hip abduction ( OR = 0.9 [ 1 ° ] , P = 0.05 ) . Previous injury was also identified as a risk factor for knee ( OR = 4.6 ) and ankle sprains ( OR = 5.3 ) . Conclusions Age and previous injury were identified as the main risk factors for injury among elite football players from Icel and",
"PURPOSE The purpose of this prospect i ve study was to examine rates and risk factors for overuse injuries among 824 women during Marine Corps Recruit Depot basic training at Parris Isl and , SC , in 1999 . METHODS Data collected included training day exposures ( TDE ) , baseline performance on a st and ardized 1.5-mile timed run , and a pretraining question naire highlighting exercise and health habits . The women were followed during training for occurrence of stress fracture and other lower-extremity overuse injury . RESULTS There were 868 lower-extremity overuse injuries for an overall injury rate of 12.6/1000 TDE . Rates for initial and subsequent injury were 8.7/1000 and 20.7/1000 TDE , respectively . There were 66 confirmed lower-extremity stress fractures among 56 ( 6.8 % ) women ( 1.0/1000 TDE ) . Logistic regression modeling indicated that low aerobic fitness ( a slower time on the timed run ( > 14.4 min ) ) , no menses in six or more consecutive months during the past year , and less than 7 months of lower-extremity weight training were significantly associated with stress fracture incidence . Self-rated fair-poor fitness at baseline was the only variable significantly associated with other non-stress fracture overuse injury during basic training . CONCLUSIONS Among this sample of women , the risk of lower-extremity overuse injury was high , with a twofold risk of subsequent injury . The results suggest that stress fracture injury might be decreased if women entered training with high aerobic fitness and participated frequently in lower-extremity strength training . Furthermore , women reporting a history of menstrual irregularity at their initial medical exam may require closer observation during basic training",
"BACKGROUND This study examined whether assigning running shoes based on the shape of the bottom of the foot ( plantar surface ) influenced injury risk in Air Force Basic Military Training ( BMT ) and examined risk factors for injury in BMT . METHODS Data were collected from BMT recruits during 2007 ; analysis took place during 2008 . After foot examinations , recruits were r and omly consigned to either an experimental group ( E , n=1042 men , 375 women ) or a control group ( C , n=913 men , 346 women ) . Experimental group recruits were assigned motion control , stability , or cushioned shoes for plantar shapes indicative of low , medium , or high arches , respectively . Control group recruits received a stability shoe regardless of plantar shape . Injuries during BMT were determined from outpatient visits provided from the Defense Medical Surveillance System . Other injury risk factors ( fitness , smoking , physical activity , prior injury , menstrual history , and demographics ) were obtained from a question naire , existing data bases , or BMT units . RESULTS Multivariate Cox regression controlling for other risk factors showed little difference in injury risk between the groups among men ( hazard ratio [E/C]=1.11 , 95 % CI=0.89 - 1.38 ) or women ( hazard ratio [E/C]=1.20 , 95 % CI= 0.90 - 1.60 ) . Independent injury risk factors among both men and women included low aerobic fitness and cigarette smoking . CONCLUSIONS This prospect i ve study demonstrated that assigning running shoes based on the shape of the plantar surface had little influence on injury risk in BMT even after controlling for other injury risk factors",
"Physical training-related injuries are common among army recruits and other vigorously active population s , but little is known about their causation . To identify intrinsic risk factors , we prospect ively measured 391 army trainees . For 8 weeks of basic training , 124 men and 186 women ( 79.3 % ) were studied . They answered question naires on past activities and sports participa tion , and were measured for height , weight , and body fat percentage ; 71 % of the subjects took an initial army physical training test . Women had a significantly higher incidence of time-loss injuries than men , 44.6 % com pared with 29.0 % . During training , more time-loss in juries occurred among the 50 % of the men who were slower on the mile run , 29.0 % versus 0.0 % . Slower women were likewise at greater risk than faster ones , 38.2 % versus 18.5 % . Men with histories of inactivity and with higher body mass index were at greater injury risk than other men , as were the shortest women . We conclude that female gender and low aerobic fitness measured by run times are risk factors for training injuries in army trainees , and that other factors such as prior activity levels and stature may affect men and women differently",
"Abstract The aim of this study was to investigate changes in running mechanics and spring-mass behaviour with fatigue induced by 5-hour hilly running ( 5HHR ) . Running mechanics were measured pre- and post-5HHR at 10 , 12 and 14 km · h-1 on an instrumented treadmill in eight ultramarathon runners , and sample d at 1000 Hz for 10 consecutive steps . Contact ( tc ) and aerial ( ta ) times were determined from ground reaction force ( GRF ) signals and used to compute step frequency ( f ) . Maximal GRF , loading rate , downward displacement of the centre of mass ( Δz ) , and leg length change ( ΔL ) during the support phase were determined and used to compute both vertical ( Kvert ) and leg ( Kleg ) stiffness . A significant decrease in tc was observed at 12 and 14 km · h-1 result ing in an increase of f at all speeds . Duty factor and Fmax significantly decreased at 10 km · h-1 . A significant increase in Kvert and Kleg was observed at all running speeds with significant decreases in Δz and ΔL . Despite the shorter duration , the changes in running mechanics appeared to be in the same direction ( increased f and Kvert , decrease in Δz and Fmax ) but of lower amplitude compared with those obtained after an ultra-trail or an ultramarathon",
"Background A one-year prospect i ve examination of injury rates and injury risk factors was conducted in Federal Bureau of Investigation ( FBI ) new agent training . Methods Injury incidents were obtained from medical records and injury compensation forms . Potential injury risk factors were acquired from a lifestyle question naire and existing data at the FBI Academy . Results A total of 426 men and 105 women participated in the project . Thirty-five percent of men and 42 % of women experienced one or more injuries during training . The injury incidence rate was 2.5 and 3.2 injuries/1,000 person-days for men and women , respectively ( risk ratio ( women/men ) = 1.3 , 95 % confidence interval = 0.9 - 1.7 ) . The activities most commonly associated with injuries ( % of total ) were defensive tactics training ( 58 % ) , physical fitness training ( 20 % ) , physical fitness testing ( 5 % ) , and firearms training ( 3 % ) . Among the men , higher injury risk was associated with older age , slower 300-meter sprint time , slower 1.5-mile run time , lower total points on the physical fitness test ( PFT ) , lower self-rated physical activity , lower frequency of aerobic exercise , a prior upper or lower limb injury , and prior foot or knee pain that limited activity . Among the women higher injury risk was associated with slower 300-meter sprint time , slower 1.5-mile run time , lower total points on the PFT , and prior back pain that limited activity . Conclusion The results of this investigation supported those of a previous retrospective investigation emphasizing that lower fitness and self-reported pain limiting activity were associated with higher injury risk among FBI new agents",
"Background : Injuries in collegiate ice hockey can result in significant time lost from play . The identification of modifiable risk factors relating to a player ’s physical fitness allows the development of focused training and injury prevention programs targeted at reducing these risks . Purpose : To determine the ability of preseason fitness outcomes to predict in-season on-ice injury in male collegiate ice hockey players . Study Design : Prognostic cohort study . Level of Evidence : Level 3 . Methods : Athlete demographics , percentage body fat , aerobic capacity ( 300-m shuttle run ; 1- , 1.5- , 5-mile run ) , and strength assessment ( sit-ups , push-ups , grip strength , bench press , Olympic cleans , squats ) data were collected at the beginning of 8 successive seasons for 1 male collegiate ice hockey team . Hockey-related injury data and player-level practice /game athlete exposure ( AE ) data were also prospect ively collected . Seventy-nine players participated ( 203 player-years ) . Injury was defined as any event that result ed in the athlete being unable to participate in 1 or more practice s or games following the event . Multivariable logistic regression was performed to determine the ability of the independent variables to predict the occurrence of on-ice injury . Results : There were 132 injuries ( mean , 16.5 per year ) in 55 athletes . The overall injury rate was 4.4 injuries per 1000 AEs . Forwards suffered 68 % of the injuries . Seventy percent of injuries occurred during games with equal distribution between the 3 periods . The mean number of days lost due to injury was 7.8 ± 13.8 ( range , 1 - 127 days ) . The most common mechanism of injury was contact with another player ( 54 % ) . The odds of injury in a forward was 1.9 times ( 95 % CI , 1.1 - 3.4 ) that of a defenseman and 3 times ( 95 % CI , 1.2 - 7.7 ) that of a goal ie . The odds of injury if the player ’s body mass index ( BMI ) was ≥25 kg/m2 was 2.1 times ( 95 % CI , 1.1 - 3.8 ) that of a player with a BMI odds ratios for bench press , maximum sit-ups , and Olympic cleans were statistically significant but close to 1.0 , and therefore the clinical relevance is unknown . Conclusion : Forwards have higher odds of injury relative to other player positions . BMI was predictive of on-ice injury . Aerobic fitness and maximum strength outcomes were not strongly predictive of on-ice injury",
"Reliable data on the impact of physical training on light infantry units in terms of injuries and time loss are sparse . This study evaluated a light infantry unit ( n = 181 ) prospect ively and followed it throughout one year of infantry training and operations . Fifty-five percent of the soldiers ( n = 101 ) experienced one or more injuries . Eighty-eight percent of the injuries were training-related conditions , which result ed in 1,103 days of limited duty . Lower extremity overuse injuries were the most common type of injury documented . Fractures accounted for the greatest number of days of limited duty . Risk factors for training-related injuries identified by this study were cigarette smoking , high percentage of body fat , extremely high or low body mass index , low endurance levels , and low muscular endurance levels ( sit-ups ) . Logistic regression showed that cigarette smoking and low endurance levels were independent risk factors for training injuries . These data indicate that the incidence of training-related injuries in infantry units is high . A number of modifiable injury risk factors were identified , suggesting that many of these injuries may be preventable",
"Background : The incidence of lower extremity injuries in female soccer players is high , but the risk factors for injuries are unknown . Purpose : To investigate risk factors for lower extremity injuries in elite female soccer players . Study Design : Cohort study ; Level of evidence , 3 . Methods : Players in the Norwegian elite female soccer league ( N = 12 teams ) participated in baseline screening tests before the 2009 competitive soccer season . The screening included tests assessing maximal lower extremity strength , dynamic balance , knee valgus angles in a drop-jump l and ing , knee joint laxity , generalized joint laxity , and foot pronation . Also included was a question naire to collect information on demographic data , elite-level experience , and injury history . Time-loss injuries and exposure in training and matches were recorded prospect ively in the subsequent soccer season using weekly text messaging . Players reporting an injury were contacted to collect data regarding injury circumstances . Univariate and multivariate regression analyses were used to calculate odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) for ±1 st and ard deviation of change . Results : In total , 173 players underwent complete screening tests and registration of injuries and exposure throughout the season . A total of 171 injuries in 107 players ( 62 % ) were recorded ; ligament and muscle injuries were the most frequent . Multivariate analyses showed that a greater body mass index ( BMI ) ( OR , 1.51 ; 95 % CI , 1.21 - 1.90 ; P = .001 ) was the only factor significantly associated with new lower extremity injuries . A greater BMI was associated with new thigh injuries ( OR , 1.51 ; 95 % CI , 1.08 - 2.11 ; P = .01 ) , a lower knee valgus angle in a drop-jump l and ing was associated with new ankle injuries ( OR , 0.64 ; 95 % CI , 0.41 - 1.00 ; P = .04 ) , and a previous knee injury was associated with new lower leg and foot injuries ( OR , 3.57 ; 95 % CI , 1.27 - 9.99 ; P = .02 ) , whereas none of the factors investigated influenced the risk of new knee injuries . Conclusion : A greater BMI was associated with lower extremity injuries in elite female soccer players . Clinical Relevance : Increased knowledge on risk factors for lower extremity injuries enables more targeted prevention strategies with the aim of reducing injury rates in female soccer players",
"Objective To identify gender-specific predictors of lower extremity injury among a sample of adults engaging in running , walking , or jogging ( RWJ ) for exercise . Design Prospect i ve cohort study . Setting Cooper Clinic Preventive Medicine Center , Dallas , Texas . Participants Participants were 2,481 men and 609 women who underwent a physical examination between 1970 and 1981 and returned a follow-up survey in 1986 . Predictor variables measured at baseline included height , weight , and cardiorespiratory fitness . At follow-up , participants recalled information about musculoskeletal injuries , physical activity levels , and other predictors for lower extremity injury over two time periods , 5 years and 12 months . Main Outcome Measures An injury was defined as any self-reported lower extremity injury that required a consultation with a physician . Cox proportional hazards regression ( HR ) was used to predict the probability of lower extremity injury for the 5-year recall period , and unconditional logistic regression was used for the 12-month recall period . Results Among men , previous lower extremity injury was the strongest predictor of lower extremity injury ( HR = 1.93–2.09 ) , regardless of recall period . Among women , RWJ mileage > 20 miles/wk was the strongest predictor for the 5-year period ( HR = 2.08 ) , and previous lower extremity injury was the strongest predictor for the 12-month period ( HR = 2.81 ) . Conclusions For healthy adults , walking at a brisk pace for 10–20 miles per week accumulates adequate moderate-intensity physical activity to meet national recommendations while minimizing the risk for musculoskeletal lower extremity injury . Clinicians may use this information to provide appropriate injury prevention counseling to their active patients",
"Knapik , JJ , Swedler , DI , Grier , TL , Hauret , KG , Bullock , SH , Williams , KW , Darakjy , SS , Lester , ME , Tobler , SK , and Jones , BH . Injury reduction effectiveness of selecting running shoes based on plantar shape . J Strength Cond Res 23(3 ) : 685 - 697 , 2009-Popular running magazines and running shoe companies suggest that imprints of the bottom of the feet ( plantar shape ) can be used as an indication of the height of the medial longitudinal foot arch and that this can be used to select individually appropriate types of running shoes . This study examined whether or not this selection technique influenced injury risk during United States Army Basic Combat Training ( BCT ) . After foot examinations , BCT recruits in an experimental group ( E : n = 1,079 men and 451 women ) selected motion control , stability , or cushioned shoes for plantar shapes judged to represent low , medium , or high foot arches , respectively . A control group ( C : n = 1,068 men and 464 women ) received a stability shoe regardless of plantar shape . Injuries during BCT were determined from outpatient medical records . Other previously known injury risk factors ( e.g. , age , fitness , and smoking ) were obtained from a question naire and existing data bases . Multivariate Cox regression controlling for other injury risk factors showed little difference in injury risk between the E and C groups among men ( risk ratio ( E/C ) = 1.01 ; 95 % confidence interval = 0.88 - 1.16 ; p = 0.87 ) or women ( risk ratio ( E/C ) = 1.07 ; 95 % confidence interval = 0.91 - 1.25 ; p = 0.44 ) . In practical application , this prospect i ve study demonstrated that selecting shoes based on plantar shape had little influence on injury risk in BCT . Thus , if the goal is injury prevention , this selection technique is not necessary in BCT",
"PURPOSE The purpose of this prospect i ve study was to investigate the epidemiology of overuse injuries and to identify common risk factors for stress fractures among female and male recruits in a new light infantry basic training design ed to minimize the incidence of overuse injuries . METHODS Study subjects were male and female recruits in the 16-wk light infantry basic training . A control group of noncombat female medics whose military service did not include dem and ing physical activities was recruited to assess the female recruits ' preinduction physical preparedness . Pretraining survey of all participants ' medical and sports participation histories was conducted . Anthropometric measurements were performed . Subjects were followed every 3 wk for overuse injuries . Stress fractures were diagnosed by radiography or scintigraphy . RESULTS Ninety-nine female recruits , 36 male recruits , and 55 controls participated . Although 31 % of the controls reported regular preinduction sports participation , less than 25 % of both male and female recruits did . Stress fractures incidence was 0 % among males and controls but 12 % among female recruits ( P = 0.03 ) . The mean body mass index of female recruits with stress fractures was 19.2 + /- 2.6 versus 22.5 + /- 3.3 kg x m of female recruits without stress fractures ( P = 0.02 , odds ratio = 1.397 , 95 % confidence interval = 1.065 - 1.833 ) . No statistically significant difference was found between female and male military trainees in the incidence of other overuse injuries , but there was a statistical trend ( P = 0.07 ) for more back pain among females . CONCLUSIONS Lower body mass index was the only variable identified as a risk factor for stress fractures among female recruits in the present study . It does not explain the markedly different response of female and male recruits ' bones to the low dem and training . There may be an intrinsic difference between male and female bone resistance to fatigue",
"Sedentary individuals , particularly new military recruits , who start a physical training program have a substantial risk of developing an overuse injury of the lower limb . In this study we investigated the effect of neoprene insoles on the incidence of overuse injuries during 9 weeks of basic military training . The experimental group consisted of 237 r and omly selected new recruits , while 1151 recruits were the control group . Insoles were given to the experimental group and compliance was monitored . A panel of doctors documented and classi fied all injuries occurring during the 9 week period . A total of 54 ( 22.8 % ) and 237 ( 31.9 % ) injuries were reported in the experimental and control groups , re spectively . In both groups , the majority of injuries were overuse ( experimental group , 90.7 % ; control group , 86.4 % ) . The mean weekly incidence of total overuse injuries and tibial stress syndrome was significantly lower ( P mean incidence of stress fractures was lower in the experimental group but not significantly so ( 0.05 total overuse injuries and tibial stress syndrome during 9 weeks of basic military training can be reduced by wearing insoles",
"PURPOSE The purpose of this study was to identify rates of diagnosis-specific musculoskeletal injuries in U.S. Marine Corps recruits and to examine the association between patterns of physical training and these injuries . METHODS Subjects were 1,296 r and omly selected male Marine recruits , ages 17 to 28 yr , who reported to Marine Corps Recruit Depot San Diego for boot camp training between January 12 and September 14 , 1993 . Recruits were followed prospect ively through 12 wk of training for injury outcomes . Injury patterns were examined in relation to weekly volumes and types of vigorous physical training . RESULTS The overall injury rate was 39.6 % ( number of recruits injured/ population at risk ) , with 82 % of injuries occurring in the lower extremities . Overuse injuries accounted for 78 % of the diagnoses . The most frequent site of injury was the ankle/foot region ( 34.3 % of injuries ) , followed by the knee ( 28.1 % ) . Ankle sprains ( 6.2 % , N = 1,143 ) , iliotibial b and syndrome ( 5.3 % , N = 1,143 ) , and stress fractures ( 4.0 % , N = 1,296 ) were the most common diagnoses . Injury rates were highest during the weeks with high total volumes of vigorous physical training and the most hours of running and marching . Weekly injury rates were significantly correlated with hours of vigorous physical training ( overuse injuries r = 0.667 , P = 0.018 ; acute injuries r = 0.633 , P = 0.027 ) . CONCLUSIONS The results of this controlled epidemiological investigation indicate that volume of vigorous physical training may be an etiologic factor for exercise-related injuries . The findings also suggest that type of training , particularly running , and abrupt increases in training volume may further contribute to injury risk",
"Medial tibial stress syndrome ( MTSS ) is a common injury in active population s and has been suggested to be a result of both biomechanical and lifestyle factors . The main aim of this study was to determine prospect ively whether gait biomechanics and lifestyle factors can be used as a predictor of MTSS development . British infantry male recruits ( n=468 ) were selected for the study . Plantar pressure variables , lifestyle factors comprising smoking habit and aerobic fitness as measured by a 1.5 mile timed-run were collected on the first day of training . Injury data were collected during the 26 week training period and incidence rate was 7.9 % ( n=37 ) . A logistic regression model for membership of the MTSS and non-MTSS groups was developed . An imbalance in foot pressure with greater pressure on the medial side than on the lateral side was the primary risk factor . Low aerobic fitness , as deduced from a 1.5 mile timed-run and smoking habit were also important , but were additive risk factors for MTSS . In conclusion , \" poor \" biomechanics were the strongest predictors of MTSS development but lifestyle factors were also important . The logistic regression model combining all three risk factors was capable of predicting 96.9 % of the non-injured group and 67.5 % of the MTSS group with an overall accuracy of 87.7 % . While the model has yet to be vali date d against an external sample and limitations exist with regards to the quality of the data collected , it is nonetheless suggested that the combined analysis of biomechanical and lifestyle factors has the potential to improve the prediction of MTSS",
"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",
"OBJECTIVE To evaluate the association of pre-accession physical fitness , as measured by a five-minute step test , with incidence of overuse injuries and outpatient healthcare utilization among male United States ( US ) Army recruits . PARTICIPANTS US Army male trainees who met weight st and ards and took a pre-accession fitness test . METHODS In this prospect i ve cohort study , incidence and outpatient healthcare visits for overuse injuries during the first 90 days of military service were compared between recruits who failed the pre-accession step test with those who passed . RESULTS The hazard rate ratio for injury among recruits who failed the fitness test compared to those who passed the test was 1.31 ( 95 % C.I = 1.20 - 1.44 ) . Among the subset of recruits with at least one medical encounter for an overuse injury , the utilization rate ratio for subjects who failed the fitness test versus those who passed was 1.15 ( 95 % C.I = 1.09 - 1.22 ) . Other factors associated with increased risk of injury or healthcare utilization include age , body mass index , and smoking history . CONCLUSIONS Risk of injury and utilization were associated with fitness test results . These findings may have implication s for military accession and training policy as well as for other physically dem and ing training programs such as police , fire fighters and athletes",
"Background Musculoskeletal injury is the most common reason that soldiers are medically not ready to deploy . Underst and ing intrinsic risk factors that may place an elite soldier at risk of musculoskeletal injury may be beneficial in preventing musculoskeletal injury and maintaining operational military readiness . Findings from this population may also be useful as hypothesis-generating work for particular civilian setting s such as law enforcement officers ( SWAT teams ) , firefighters ( smoke jumpers ) , or others in physically dem and ing professions . Questions / purpose sThe purpose s of this study were ( 1 ) to examine whether using baseline measures of self-report and physical performance can identify musculoskeletal injury risk ; and ( 2 ) to determine whether a combination of predictors would enhance the accuracy for determining future musculoskeletal injury risk in US Army Rangers . Methods Our study was a planned secondary analysis from a prospect i ve cohort examining how baseline factors predict musculoskeletal injury . Baseline predictors associated with musculoskeletal injury were collected using surveys and physical performance measures . Survey data included demographic variables , injury history , and biopsychosocial questions . Physical performance measures included ankle dorsiflexion , Functional Movement Screen , lower and upper quarter Y-balance test , hop testing , pain provocation , and the Army Physical Fitness Test ( consisting of a 2-mile run and 2 minutes of sit-ups and push-ups ) . A total of 320 Rangers were invited to enroll and 211 participated ( 66 % ) . Occurrence of musculoskeletal injury was tracked for 1 year using monthly injury surveillance surveys , medical record review s , and a query of the Department of Defense healthcare utilization data base . Injury surveillance data were available on 100 % of the subjects . Receiver operator characteristic curves and accuracy statistics were calculated to identify predictors of interest . A logistic regression equation was then calculated to find the most pertinent set of predictors . Of the 188 Rangers ( age , 23.3 ± 3.7 years ; body mass index , 26.0 ± 2.4 kg/m2 ) remaining in the cohort , 85 ( 45.2 % ) sustained a musculoskeletal injury of interest . Results Smoking , prior surgery , recurrent prior musculoskeletal injury , limited-duty days in the prior year for musculoskeletal injury , asymmetrical ankle dorsiflexion , pain with Functional Movement Screen clearing tests , and decreased performance on the 2-mile run and 2-minute sit-up test were associated with increased injury risk . Presenting with one or fewer predictors result ed in a sensitivity of 0.90 ( 95 % confidence interval [ CI ] , 0.83–0.95 ) , and having three or more predictors result ed in a specificity of 0.98 ( 95 % CI , 0.93–0.99 ) . The combined factors that contribute to the final multivariable logistic regression equation yielded an odds ratio of 4.3 ( 95 % CI , 2.0–9.2 ) , relative risk of 1.9 ( 95 % CI , 1.4–2.6 ) , and an area under the curve of 0.64 . Conclusions Multiple factors ( musculoskeletal injury history , smoking , pain provocation , movement tests , and lower scores on physical performance measures ) were associated with individuals at risk for musculoskeletal injury . The summation of the number of risk factors produced a highly sensitive ( one or less factor ) and specific ( three or more factors ) model that could potentially be used to effectively identify and intervene in those persons with elevated risk for musculoskeletal injury . Future research should establish if screening and intervening can improve musculoskeletal health and if our findings among US Army Rangers translate to other occupations or athletes . Level of Evidence Level II , prognostic study",
"PURPOSE The aim of the present study was to assess the risk factors for magnetic resonance imaging (MRI)-detected bone stress injuries in the pelvis , hip , thigh , and knee in a large cohort of Finnish conscripts during a follow-up of 102,515 person-years . METHODS An epidemiologic prospect i ve cohort study of 152,095 conscripts , including 2345 ( 1.5 % ) females , was conducted . Localized pain in the pelvis , hip , thigh , or knee result ed in an orthopedic surgeon 's consultation and subsequent MRI examination at the Central Military Hospital , Helsinki , Finl and . Risk factors were systematic ally collected from 1998 to 2004 , including data on conscripts ' physical fitness and body composition measured at the beginning of their military service . RESULTS Altogether , 319 MRI-detected bone stress injuries of the pelvis , hip , thigh , or knee were identified in our cohort ; thus , the incidence was 311 ( 95 % CI : 277 - 345 ) per 100,000 person-years . The female : male ratio varied substantially , depending on the anatomic location of the injury ; it was highest for sacral injuries ( female : male ratio = 51.1 ) and lowest for injuries of the femoral condyle ( female : male ratio = 0.8 ) . In univariate Cox regression analysis , poor muscle strength and a poor result in a 12-min run were significantly associated with bone stress injuries . In multivariable analysis , the strongest risk factors for bone stress injuries were female gender ( hazard ratio 8.2 ; 95 % CI : 4.8 - 14.2 ) and higher age ( hazard ratio 2.1 ; 95 % CI : 1.4 - 3.1 ) . CONCLUSIONS Female military trainees have a highly increased risk of bone stress injuries of the pelvis and hip compared with male conscripts . Sacral stress fractures are typical bone stress injuries in female military recruits . Physicians should remember the possibility of bone stress injury , especially when examining stress-related pain symptoms of the pelvic area in physically active young adult females",
"Prospect i ve running-related injury ( RRI ) data from runners training for an event are scarce , especially with regard to RRI-associated costs . Therefore , the aim of this study was to investigate the prevalence and economic burden of RRIs in runners participating in an organized training program preparing them for an event . This was a prospect i ve cohort study with 18 weeks of follow-up . Individuals aged 18 or older and registered to participate in an organized running program were eligible . Follow-up surveys were sent every 2 weeks to collect data about running exposure , RRIs , and costs . Of the 161 potential participants , 53 ( 32.9 % ) were included in this study . A total of 32 participants reported 41 RRIs . The mean prevalence during follow-up was 30.8 % [ 95 % confidence interval ( CI ) 25.6 - 36.0 % ] . Overuse was the main mechanism of RRI ( 85.4 % , n = 35 ) . An RRI was estimated to have an economic burden of € 57.97 ( 95 % CI € 26.17 - 94.00 ) due to healthcare utilization ( direct costs ) and € 115.75 ( 95 % CI € 10.37 - 253.73 ) due to absenteeism from paid work ( indirect costs ) . These results indicate that the health and economic burden of RRIs may be considered significant for public health . Therefore , prevention programs are needed for runners participating in organized training programs",
"PURPOSE This study investigated the effect of muscle stretching during warm-up on the risk of exercise-related injury . METHODS 1538 male army recruits were r and omly allocated to stretch or control groups . During the ensuing 12 wk of training , both groups performed active warm-up exercises before physical training sessions . In addition , the stretch group performed one 20-s static stretch under supervision for each of six major leg muscle groups during every warm-up . The control group did not stretch . RESULTS 333 lower-limb injuries were recorded during the training period , including 214 soft-tissue injuries . There were 158 injuries in the stretch group and 175 in the control group . There was no significant effect of preexercise stretching on all-injuries risk ( hazard ratio [ HR ] = 0.95 , 95 % CI 0.77 - 1.18 ) , soft-tissue injury risk ( HR = 0.83 , 95 % CI 0.63 - 1.09 ) , or bone injury risk ( HR = 1.22 , 95 % CI 0.86 - 1.76 ) . Fitness ( 20-m progressive shuttle run test score ) , age , and enlistment date all significantly predicted injury risk ( P height , weight , and body mass index did not . CONCLUSION A typical muscle stretching protocol performed during preexercise warm-ups does not produce clinical ly meaningful reductions in risk of exercise-related injury in army recruits . Fitness may be an important , modifiable risk factor",
"OBJECTIVES Well-developed physical qualities may protect against contact injuries . However , the potential contribution of physical qualities as risk or protective factors to contact injury risk is yet to be determined for rugby league . This study applied a frailty survival model that accounts for recurrent injury to identify risk factors for all physiotherapist-reported contact injury in professional rugby league players . DESIGN Prospect i ve cohort study . METHODS Sixty-six professional rugby league players participated in this three successive year prospect i ve study . At the start of each season , all players underwent measurements of st and ard anthropometry ( height , body mass , and sum of seven skinfolds ) , speed ( 10 m and 40 m sprint ) , muscular strength ( 1 repetition maximum [ RM ] bench press , 1RM squat , 1RM weighted chin-ups ) , power ( vertical jump , bench throw , 1RM power clean , jump squat ) , and endurance ( maximum repetition bench press with 60 kg resistance ) , repeated-sprint ability ( 12 × 20 m sprints performed on a 20s cycle ) , prolonged high-intensity intermittent running ability ( 8 × 12 s maximal effort shuttles performed on a 48 s cycle ) , and maximal aerobic power ( multi-stage fitness test ) . Data was used to demonstrate the application of the frailty model extension of the Cox proportional regression model for recurrent events to identify factors associated with a high hazard ratio ( HR ) of injury . RESULTS Heavier ( body mass , HR=2.6 , 95 % CI=1.2 - 5.7 ) , and faster ( 40 m sprint , HR=2.1 , 95 % CI=1.0 - 4.2 ) players , and those with poorly developed prolonged high-intensity intermittent running ability ( HR=2.9 , 95 % CI=1.7 - 5.0 ) and upper-body strength ( chin-up , HR=2.2 , 95 % CI=1.3 - 3.7 ) had a higher incidence of contact injuries . CONCLUSIONS This study demonstrates application of a novel statistical approach for the analysis of injury data that is recurrent in nature . This approach identified that the greater impact forces generated from heavier players with faster speed may result in an increase in recurrent contact injury rates . However , the development of prolonged high-intensity intermittent running ability and upper-body strength and power may assist to reduce the risk of contact injury in professional rugby league players",
"Purpose This prospect i ve cohort study examined injuries and injury risk factors in 660 British Army infantry soldiers during a predeployment training cycle . Methods Soldiers completed a question naire concerning physical characteristics , occupational factors , lifestyle characteristics ( including physical training time ) and previous injury . Direct measurements included height , body mass , sit-ups , push-ups and run time . Electronic medical records were screened for injuries over a 1-year period before operational deployment . Backward-stepping Cox regression calculated HR and 95 % CI to quantify independent injury risk factors . Results One or more injuries were experienced by 58.5 % of soldiers . The new injury diagnosis rate was 88 injuries/100 person-years . Most injuries involved the lower body ( 71 % ) , especially the lower back ( 14 % ) , knee ( 19 % ) and ankle ( 15 % ) . Activities associated with injury included sports ( 22 % ) , physical training ( 30 % ) and military training/work ( 26 % ) . Traumatic injuries accounted for 83 % of all injury diagnoses . Independent risk factors for any injury were younger age ( 17–19 years ( HR 1.0 ) , 20–24 years ( HR 0.71 , 95 % CI 0.55 to 0.93 ) , 25–29 years ( HR 0.89 , 95 % CI 0.66 to 1.19 ) and 30–43 years ( HR 0.41 , 95 % CI 0.27 to 0.63 ) , previous lower limb injury ( yes/no HR 1.49 , 95 % CI 1.19 to 1.87 ) and previous lower back injury ( yes/no HR 1.30 , 95 % CI 1.03 to 1.63 ) . Conclusion British infantry injury rates were lower than those reported for US infantry ( range 101–223 injuries/100 soldier-years ) , and younger age and previous injury were identified as independent risk factors . Future efforts should target reducing the incidence of traumatic injuries , especially those related to physical training and /or sports",
"INTRODUCTION Stress fractures ( SFx ) are one of the most common and debilitating overuse injuries seen in military recruits , and they are also problematic for nonmilitary athletic population s. The goal of this r and omized double-blind , placebo-controlled study was to determine whether a calcium and vitamin D intervention could reduce the incidence of SFx in female recruits during basic training . MATERIAL S AND METHODS We recruited 5201 female Navy recruit volunteers and r and omized them to 2000 mg calcium and 800 IU vitamin D/d or placebo . SFx were ascertained when recruits reported to the Great Lakes clinic with symptoms . All SFx were confirmed with radiography or technetium scan according to the usual Navy protocol . RESULTS A total of 309 subjects were diagnosed with a SFx result ing in an incidence of 5.9 % per 8 wk . Using intention-to-treat analysis by including all enrolled subjects , we found that the calcium and vitamin D group had a 20 % lower incidence of SFx than the control group ( 5.3 % versus 6.6 % , respectively , p = 0.0026 for Fisher 's exact test ) . The per protocol analysis , including only the 3700 recruits who completed the study , found a 21 % lower incidence of fractures in the supplemented versus the control group ( 6.8 % versus 8.6 % , respectively , p = 0.02 for Fisher 's exact test ) . CONCLUSIONS Generalizing the findings to the population of 14,416 women who entered basic training at the Great Lakes during the 24 mo of recruitment , calcium and vitamin D supplementation for the entire cohort would have prevented approximately 187 persons from fracturing . Such a decrease in SFx would be associated with a significant decrease in morbidity and financial costs"
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Background Total hip arthroplasty ( THA ) is increasingly being performed in patients with long life expectancies and active lifestyles . Newer implant bearing surfaces , with superior wear characteristics , often are used in this cohort with the goal of improving longevity of the prosthesis , but comparisons across the numerous available bearing surfaces are limited , so the surgeon and patient may have difficulty deciding which implants to use . Questions / purpose sThe purpose of this study was to answer the following question : Is there a short- to mid-term survivorship difference between common THA bearings used in patients younger than age 65 years ? Methods We conducted a systematic review to identify r and omized clinical trials ( RCTs ) published after 2000 that reported survivorship of ceramic-on-ceramic ( CoC ) , ceramic-on-highly crosslinked polyethylene ( CoPxl ) , or metal-on-highly crosslinked polyethylene ( MoPxl ) bearings . To qualify for our review , RCTs had to have a minimum 2-year followup and study patients were required to have an average age younger than 65 years . Direct-comparison meta- analysis and network meta- analysis were performed to combine direct and indirect evidence . Results Direct-comparison meta- analysis found no differences among the bearing surfaces in terms of the risk of revision ; this approach demonstrated a risk ratio for revision of 0.65 ( 95 % confidence interval [ CI ] , 0.19–2.23 ; p = 0.50 ) between CoC and CoPxl and a risk ratio for revision of 0.40 ( 95 % CI , 0.06–2.63 ; p = 0.34 ) between CoC and MoPxl . Network meta- analysis ( with post hoc modification ) likewise found no differences in survivorship across the three implant types , demonstrating the following probabilities of most effective implant with 95 % credible intervals ( CrI ) : CoC = 64.6 % ( 0%–100 % ) ; CoPxl = 24.9 % ( 0%–100 % ) ; and MoPxl = 9.9 % ( 0%–100 % ) . The CrIs ranged from 0 % to 100 % for all three bearing surfaces . Direct-comparison meta- analysis allowed for pooling of five RCTs , including 779 THAs , whereas network meta- analysis ( before post hoc analysis ) enabled pooling of 18 RCTs , including 2599 THAs . Conclusions Current published evidence does not support survivorship differences among commonly used bearing surfaces in patients younger than age 65 years undergoing THA at short- to mid-term followup . Long-term RCT data will be needed to determine if a survivorship benefit is realized in younger , more active patients over time . Level of Evidence Level I , therapeutic study
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" Highly cross-linked polyethylene was developed to reduce articular bearing wear in total hip arthroplasty . In vitro studies have shown reduced wear in comparison with conventional polyethylene . A double-blind , prospect i ve , r and omized trial was performed comparing highly cross-linked and conventional polyethylene in 119 patients . The primary outcome variables were linear , 3-dimensional , and volumetric wear as determined by analysis of digitized radiographs using vali date d wear measurement software . Linear , 3-dimensional , and volumetric wear rates were significantly less in the highly cross-linked polyethylene group between 6 months and 4 years postoperatively ( P highly cross-linked polyethylene reduces short-term polyethylene wear . The intermediate and long-term clinical results of highly cross-linked polyethylene remain unknown pending further follow-up",
"Mixed treatment comparison ( MTC ) meta- analysis is a generalization of st and ard pairwise meta- analysis for A vs B trials , to data structures that include , for example , A vs B , B vs C , and A vs C trials . There are two roles for MTC : one is to strengthen inference concerning the relative efficacy of two treatments , by including both ' direct ' and ' indirect ' comparisons . The other is to facilitate simultaneous inference regarding all treatments , in order for example to select the best treatment . In this paper , we present a range of Bayesian hierarchical models using the Markov chain Monte Carlo software WinBUGS . These are multivariate r and om effects models that allow for variation in true treatment effects across trials . We consider models where the between-trials variance is homogeneous across treatment comparisons as well as heterogeneous variance models . We also compare models with fixed ( unconstrained ) baseline study effects with models with r and om baselines drawn from a common distribution . These models are applied to an illustrative data set and posterior parameter distributions are compared . We discuss model critique and model selection , illustrating the role of Bayesian deviance analysis , and node-based model criticism . The assumptions underlying the MTC models and their parameterization are also discussed",
"Ultra-high-molecular-weight polyethylene sterilised in the absence of air and highly cross-linked polyethylene have been used to avoid osteolysis and loosening in total hip replacement . Our prospect i ve r and omised study has assessed the results using two different polyethylenes associated with the same prosthetic design . We assessed 45 Allofit acetabular components with a Sulene-polyethylene liner of conventional polyethylene gamma sterilised with nitrogen and 45 Allofit acetabular components with a Durasul-polyethylene liner sterilised in ethylene oxide , both matched with an Alloclassic stem with a 28 mm modular femoral head . The prostheses were implanted between May 1999 and December 2001 . The mean follow-up was for 66.3 months ( 60 to 92 ) . The linear penetration of the femoral head was estimated at 6 weeks , at 6 and 12 months and annually thereafter from st and ardised digitised radiographs using image- analysis software . There was no loosening of any prosthetic component . There were no radiolucent lines or osteolysis . The mean rate of penetration calculated from regression analysis during the first five years was 38 microm/year ( SD 2 ) for the Sulene group and 6 microm/year ( SD 1 ) for the Durasul group ( p = 0.00002 ) . The rate of penetration of the Durasul group was 15.7 % of that of the Sulene group",
"Background Although hip arthroplasty reliably relieves pain and improves function , problems have arisen with wear and osteolysis . Highly crosslinked polyethylene has been developed to address this problem although at present there is limited clinical evidence it does so longer term . Questions / purpose sWe compared the in vivo wear of st and ard versus highly crosslinked polyethylene ( HXLP ) in primary total hip arthroplasty at a minimum of 5-year followup . Methods We enrolled 122 patients in a prospect i ve , double-blinded , r and omized trial and followed them annually to assess their progress . Annual radiographs were analyzed using previously vali date d edge detection software to assess for two-dimensional , three-dimensional , and volumetric wear . The mean follow up was 5.5 years ( range , 4.1 to 7 years ) . Results The two-dimensional wear measurements for HXLP showed lower wear compared to the conventional group ( 0.05 mm/year versus 0.26 mm/year , respectively ) . Three-dimensional and volumetric wear were similarly lower in the HXLP group . Conclusions Highly crosslinked polyethylene undergoes substantially less wear than conventional polyethylene at medium term . The effect of hip arthroplasty longevity will need to be assessed with longer-term studies , but this may lead to a decreased need for revision as a result of less wear and osteolysis . Level of Evidence Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence",
"Abstract Wear particle-induced osteolysis is a major cause of aseptic loosening in THA . Increasing wear resistance of polyethylene ( PE ) occurs by increasing the cross-link density and early reports document low wear rates with such implants . To confirm longer-term reductions in wear we compared cross-linked polyethylene ( irradiation in nitrogen , annealing ) with historical polyethylene ( irradiation in air ) in a prospect i ve , r and omized clinical study involving 48 patients who underwent THAs with a minimum followup of 7 years ( mean , 8 years ; range , 7–9 years ) . The insert material was the only variable . The Harris hip score , radiographic signs of osteolysis , and polyethylene wear were recorded annually . Twenty-three historical and 17 moderately cross-linked polyethylene inserts were analyzed ( five patients died , three were lost to followup ) . At 8 years , the wear rate was lower for cross-linked polyethylene ( 0.088 ± 0.03 mm/year ) than for the historical polyethylene ( 0.142 ± 0.07 mm/year ) . This reduction ( 38 % ) did not diminish with time ( 33 % at 5 years ) . Acetabular cyst formation was less frequent ( 39 % versus 12 % ) , affected fewer DeLee and Charnley zones ( 17 % versus 4 % ) , and was less severe for the cross-linked polyethylene . The only revision was for an aseptically loose cup in the historical polyethylene group . Moderately cross-linked polyethylene maintained its wear advantage with time and produced less osteolysis , showing no signs of aging at mid-term followup . Level of Evidence : Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence",
"The results of a prospect i ve multicenter trial comparing 357 hips r and omized to total hip arthroplasty with either ceramic-ceramic or ceramic-polyethylene couplings are presented . No statistically significant difference in clinical outcomes scores between the ceramic-ceramic and ceramic-polyethylene groups was observed at any time interval . The mean linear rate was statistically lower ( P ceramic-ceramic group ( 30.5 μm/year ) when compared with the ceramic-polyethylene group ( 218.2 μm/year ) . The rates of ceramic implant fracture ( 2.6 % ) and audible component-related noise ( 3.1 % ) were statistically higher in the ceramic-ceramic group when compared with the ceramic-polyethylene group ( P in the dislocation or revision rate between the groups at the time of last clinical follow-up",
"Purpose Very few studies have compared alumina-on-alumina ceramic and alumina-on-highly cross-linked polyethylene bearings in the same patient . The purpose of this prospect i ve r and omised study was to compare the clinical and radiographic results and the prevalence of osteolysis in cementless total hip arthroplasty using an alumina-on-alumina and alumina-on-highly cross-linked polyethylene bearings in young active patients . Methods We prospect ively compared the results of 100 patients ( 200 hips ) who had undergone a cementless total hip arthroplasty with an alumina-on-alumina ceramic bearing in one hip and an alumina-on-highly cross-linked polyethylene in the other . There were 66 men and 34 women with a mean age of 45.3 years ( range , 21–49 years ) at the time of surgery . The mean follow-up was 12.4 years ( range , 11–13 years ) . The patients were assessed clinical ly and radiographically at three months , one year , and annually thereafter . Results Harris hip , Western Ontario and McMaster Universities Osteoarthritis Index , and University of California , Los Angeles activity scores did not show statistically significant differences between the two groups of bearings preoperatively or at the time of final follow-up . Radiographic findings of the component were not significantly different between the two groups . The mean polyethylene linear penetration was 0.031 ± 0.004 mm per year . No hips in either group displayed osteolysis . The Kaplan-Meier survivorship with revision as the end point at 12.4 years was 100 % ( 95 % confidence interval [ CI ] , 94–100 % ) for the femoral component in both groups and 99 % ( 95 % CI , 93–100 % ) for the acetabular component . Conclusion The clinical and radiographic results of using an alumina-on-alumina ceramic and alumina-on-highly cross-linked polyethylene bearings were similar",
"The higher failure rate of total hip arthroplasty ( THA ) in young , active patients remains a challenge for surgeons . Recently , larger-diameter femoral heads combined with an alumina matrix composite ceramic ( BIOLOX Delta ; CeramTec AG , Plochingen , Germany ) articulation was developed to improve implant longevity and meet patients ' activity dem and s while reducing the risk of component-related complications . The purpose of this study was to determine whether this new device may provide advantages for young , active patients . A prospect i ve , r and omized , controlled trial was conducted on 93 patients ( 113 THAs ) with more than 3 years of follow-up . Patients were r and omly divided into a study group ( 51 THAs ) with a 36-mm Delta ceramic-on-ceramic ( COC ) articulation and a control group ( 62 THAs ) with a common-sized alumina ceramic head on polyethylene liner ( COP ) articulation . Clinical and radiographic results were collected to compare the outcomes and complications , including implant-related failures , osteolysis , and noises . The large-diameter Delta COC articulation provided greater range of motion improvement ( 6.1 ° more ) , similar Harris Hip Scores , and similar complication rates compared with the alumina COP articulation . This study suggests that in the short term , the large-diameter Delta COC articulation results in better range of motion with no higher complication rates ; however , mid-term ( 8 - 10 years ) or longer follow-up is necessary to determine its superiority in young , active patients",
"This study determined how ceramic-on-ceramic bearing THA affected joint-specific pain , function and stiffness in the first five postoperative years compared with ceramic-on-highly-crosslinked-polyethylene bearing THA . Subjects less than 61 years of age were r and omized to ceramic-on-ceramic ( CERAMIC ) [ n = 48 ] or ceramic-on-highly-crosslinked-polyethylene ( POLYETHYLENE ) [ n = 44 ] bearing THA . Subjects were assessed using the Western Ontario McMaster Osteoarthritis Index ( WOMAC ) and the R AND 12-Item Health Survey ( R AND -12 ) preoperatively , and at one and five years postoperatively . 92 subjects(50 ( 54 % ) males ; average age = 52 ( SD 6.6 ) years ) were enrolled . 78 ( 85 % ) subjects returned five years postoperatively . All subjects reported improvements at one and five years in all measured indices with no group differences detected . Seven ( 8 % ) subjects experienced postoperative THA complications , none related to bearing surfaces ; two subjects ( POLYETHYLENE ) required revision for instability . Both bearing surfaces provided excellent short-term results in younger subjects",
"Background Polyethylene wear-induced osteolysis is a major cause of implant loosening in total hip arthroplasty . New crosslinked polyethylenes are presumed to give lower wear rates , but no long-term clinical results are available yet . Patients and methods We compared basic material characteristics and MTS hip joint simulator wear rates of a crosslinked polyethylene ( Duration ) to those of conventional polyethylene . In a r and omized double-blind 5-year clinical follow-up study , 133 hips ( 67 conventional , 66 Duration ) in 127 patients were followed-up for an average of 5 ( 3–6 ) years . Wear rates were measured using a computer-based edge detection method . The radiographic appearances of wear-related phenomena were recorded . Results The Duration polyethylene showed a significantly lower in-vitro wear rate in the simulator study ( mean 22 ( SD 2.3 ) vs. 40 ( SD 1.5 ) mm3/106 cycles ) . Also , the in-vivo wear was lower for Duration ( mean 0.083 ( SD 0.056 ) mm/year ) than for conventional polyethylene ( mean 0.123 ( SD 0.082 ) mm/year ) . All radiographic signs of osteolysis were less frequent in the Duration group . Interpretation Our study has given a substantial body of evidence —from lower wear rates , less frequent signs of osteolysis , and higher survival rates after a mean follow-up of 5 years — that Duration provides better clinical outcomes than conventional polyethylene",
"BACKGROUND Early reports on modern ceramic-on-ceramic total hip replacements have demonstrated excellent clinical and radiographic results with few cases of catastrophic failure , which , in the case of earlier design s , often had been caused by implant fracture . Several reports , however , have noted the presence of audible squeaking . The purpose of the present study was to determine the incidence of squeaking in association with the use of this bearing couple . METHODS During the period from March 2003 to May 2005 , three surgeons performed 159 total hip arthroplasties in 143 patients with use of a ceramic-on-ceramic bearing . One hundred and forty-nine hips ( 131 patients ) were available for review after at least one year of follow-up . These patients were followed prospect ively with use of the modified Hospital for Special Surgery hip score and a patient-administered question naire . Additionally , a control group of sixty hips ( forty-eight patients ) with a metal-on-polyethylene bearing was matched to the ceramic group on the basis of age , sex , and body mass index to compare the incidence of squeaking and other noises . Radiographic evaluations were performed according to previously established criteria . RESULTS Fourteen ( 10.7 % ) of 131 patients described an audible squeak during normal activities . However , squeaking was reproducible clinical ly in only four patients , and only one patient complained of squeaking before being presented with the question naire . The average Hospital for Special Surgery score improved from 19.8 preoperatively to 38.4 at the time of the latest follow-up , indicating excellent clinical results . Ninety-five percent of the patients had a satisfaction score of > or = 8 of 10 . Three hips dislocated . One of those three hips squeaked and was revised because of recurrent dislocations . One patient was considering revision because of squeaking . In the matched metal-on-polyethylene cohort , there were no cases of squeaking . CONCLUSIONS The squeaking hip is a phenomenon that is unique to total hip replacements with hard-on-hard bearings . The incidence of squeaking in association with ceramic-on-ceramic bearings may be higher than previously reported as squeaking are yet to be determined . The use of hard-on-hard bearings offers many advantages in terms of wear reduction , especially for young and active patients . Nonetheless , patients considering ceramic-on-ceramic bearings should be counseled with regard to this phenomenon",
"The ideal bearing surface for young patients undergoing total hip replacement ( THR ) remains controversial . We report the five-year results of a r and omised controlled trial comparing the clinical and radiological outcomes of 102 THRs in 91 patients who were These patients were r and omised to receive a cobalt-chrome on ultra-high-molecular-weight polyethylene , cobalt-chrome on highly cross-linked polyethylene , or a ceramic-on-ceramic bearing . In all , 97 hip replacements in 87 patients were available for review at five years . Two hips had been revised , one for infection and one for peri-prosthetic fracture . At the final follow-up there were no significant differences between the groups for the mean Western Ontario and McMaster Universities osteoarthritis index ( pain , p = 0.543 ; function , p = 0.10 ; stiffness , p = 0.99 ) , Short Form-12 ( physical component , p = 0.878 ; mental component , p = 0.818 ) or Harris hip scores ( p = 0.22 ) . Radiological outcomes revealed no significant wear in the ceramic group . Comparison of st and ard and highly cross-linked polyethylene , however , revealed an almost threefold difference in the mean annual linear wear rates ( 0.151 mm/year versus 0.059 mm/year , respectively ) ( p < 0.001 )",
"Cross-linked liners were introduced with the promise that they would substantially reduce polyethylene wear . In 1999 , our institution initiated a prospect i ve study to compare the outcome of total hip arthroplasty patients who were r and omized to non-cross-linked Enduron liners with that of total hip arthroplasty patients who were r and omized to Marathon polyethylene liners that had been cross-linked with 5 Mrad ( 50 kGy ) of gamma-irradiation and heat-treated to eliminate free radicals . At a mean follow-up of 5.7 years , the clinical outcomes among the Marathon and Enduron liners were similar . However , the mean wear rate was 0.01 + /- 0.07 mm/y for the Marathon group , which represents a 95 % reduction compared with the mean wear rate of 0.19 + /- 0.12 mm/y for the Enduron group . In addition , the incidence of osteolysis was lower in the Marathon group",
"Although the published studies on the outcomes of total hip arthroplasty ( THA ) performed with currently available ceramic components show high survivorship and low bearing wear at midterm followup , concern over ceramic fracture and squeaking persist . For these reasons , the use of ceramic is limited . Recently , a new alumina matrix composite material ( Delta ceramic ) with improved material properties was developed to address these concerns . We report the early outcomes and complications of a prospect i ve , r and omized , multicenter trial of 263 patients ( 264 hips ) at eight centers , comparing a Delta ceramic-on-ceramic ( COC ) articulation with a Delta ceramic head-crosslinked polyethylene bearing combination ( COP ) . There were 177 COC hips and 87 COP hips . Complications were reported for all patients , whereas clinical and radiographic results were provided for the 233 patients with minimum 2-year followup ( average , 31.2 months ; range , 21–49 months ) . The Harris hip scores and clinical , radiographic , and survivorship outcomes were similar in both groups . There were four ( 2 % ) revisions in the COC group and two ( 2 % ) in the COP group . We encountered three intraoperative ceramic liner-related events . In addition , one patient receiving the COC underwent revision for chipping of the ceramic liner , and a second had ceramic fragmentation on followup radiographs but has not undergone revision . These liner related complications remain a concern . No patient reported squeaking in either group ; this leaves us hopeful the new material will lessen the frequency of squeaking . In the short term , the Delta COC articulation provided similar functional scores and survivorship and complication rates with the ceramic head mated with crosslinked polyethylene . Level of Evidence : Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence"
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& NA ; Current evidence suggests that statin use decreases the incidence of cardiovascular diseases ( CVD ) through reducing LDL cholesterol and decreasing inflammation . Metabolic syndrome ( MetS ) is usually associated with increased inflammatory markers and increased risk of CVD . We conducted a systematic review and meta‐ analysis to determine the effect of statin use on inflammatory markers including C‐reactive protein ( CRP ) , tumor necrosis factor‐&agr ; ( TNF‐&agr ; ) , interleukin‐6 ( IL‐6 ) and interleukin‐1 ( IL‐1 ) among patients with MetS and related disorders . PubMed , EMBASE , Web of Science data bases , and Cochrane Library were search ed for r and omized controlled trials ( RCTs ) through April 2018 . Three independent investigators evaluated study eligibilities , extracted data , and assessed study quality using the Cochrane Collaboration risk of bias tool and Jadad 's quality scales . Heterogeneity was determined using Cochran 's Q statistic and I‐square ( I2 ) test . Based on the heterogeneity results , we pooled data using r and om‐effect or fixed effect models presented as st and ardized mean differences ( SMD ) and corresponding 95 % confidence intervals ( CI ) . One hundred thirteen RCTs ( 19,644 patients ) were included in our meta‐ analysis . The pooled results using r and om effects model showed that statin use statistically significantly decreased CRP level ( SMD= ‐0.97 ; 95 % CI , ‐1.10 , ‐0.85 ; P ) , TNF‐&agr ; ( SMD= ‐1.88 ; 95 % CI , ‐2.40 , ‐1.38 ; P 97.2 % ) , IL‐6 ( SMD= ‐1.67 ; 95 % CI , ‐1.98 , ‐1.34 ; P 96.5 % ) , and IL‐1 concentrations ( SMD= ‐8.35 ; 95 % CI , ‐10.49 , ‐6.22 ; P patients with MetS and related disorders . Our meta‐ analysis showed beneficial effects of statin use on reducing inflammatory markers in patients with MetS and related disorders
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"Statin treatment in patients with coronary heart disease is associated with a reduced incidence of short-term adverse events and endpoint cardiac events . However , the effects of statin treatment on atherosclerotic plaques , particularly stable plaques , remain poorly defined . In total , 228 consecutive patients with stable atherosclerotic plaques who had undergone coronary arteriography ( CAG ) and intravascular ultrasound ( IVUS ) were r and omly assigned to receive placebo ( placebo group , n=54 ) or atorvastatin ( ATOR ) at a single daily dose of 10 mg ( ATOR 10 mg group , n=47 ) , 20 mg ( ATOR 20 mg group , n=45 ) , 40 mg ( ATOR 40 mg group , n=43 ) or 80 mg ( ATOR 80 mg group , n=39 ) . Endpoints , including serum lipids , serum inflammation , plaque volume and percentage of plaque necrosis were assessed after 3–6 months . At baseline , mean low-density lipoprotein ( LDL ) , high-density lipoprotein ( HDL ) and high-sensitivity C-reactive protein ( hs-CRP ) levels , as well as plaque volumes and percentages of plaque necrosis , were similar between all groups . At 6 months of follow-up , the LDL levels in the ATOR groups were below those at their respective baselines ( P in the ATOR 80 mg group following treatment were significantly higher compared with baseline ( P=0.001 ) . Additionally , they were significantly higher compared with those in the placebo , ATOR 10 , 20 and 40 mg groups ( P P=0.048 , P=0.047 , respectively ) . Hs-CRP levels in the placebo group following treatment were higher compared with baseline levels ( 6.87±2.62 vs. 5.07±1.80 , P , but hs-CRP levels in the ATOR 80 mg group following treatment were lower compared with baseline ( 3.59±1.07 vs. 6.10±2.12 , P . According to the virtual histology ( VH ) of IVUS , the percentages of plaque necrosis following treatment in the placebo and ATOR 10 mg groups rose above baseline levels ( 15.51±12.56 vs. 7.69±1.31 % , 13.54±11.76 vs. 7.83±1.43 % , P % ) . By contrast , in the ATOR 20 , 40 and 80 mg groups , percentages of plaque necrosis remained stable following treatment compared with baseline ( P=0.069 , 0.846 and 0.643 , respectively ) . Plaque volumes following treatment in the placebo , ATOR 10 and 20 mg groups were similar to baseline levels . However , in the ATOR 40 and 80 mg groups , plaque volumes decreased following treatment compared with baseline plaque volumes ( 30.69±8.12 vs. 37.09±12.01 mm3 , 24.99±1.01 vs. 36.47±14.68 mm3 , P=0.019 , P respectively ) . ATOR ( 20 mg/day ) is able to lower LDL to st and ard levels while ATOR 40 mg/day was superior to 20 mg/day and had similar effects to 80 mg/day . Only ATOR 80 mg/day was able to increase HDL levels . Hs-CRP in patients without ATOR was higher and ATOR 80 mg/day decreased levels . ATOR ≥20 mg/day is able to stabilize plaques and ATOR 80 mg/day was superior to 20 and 40 mg/day . Thus , ATOR 40–80 mg/day reduces the volume of plaques ",
"The purpose of this 20-week , open-label , r and omized clinical trial was to evaluate the effect of rosuvastatin on fasting serum lipids and lipoproteins , high-sensitivity C-reactive protein ( hs-CRP ) , and the glomerular filtration rate ( GFR ) in 91 patients with chronic kidney disease . Patients were r and omized to rosuvastatin 10 mg/day ( n = 48 ) or to no lipid-lowering treatment ( n = 43 ) for 20 weeks . In contrast to patients not receiving rosuvastatin , patients receiving rosuvastatin tended to derive more favorable improvements from baseline values in low-density lipoprotein cholesterol ( -43 % , p treatment ) , hs-CRP ( -47 % , p treatment ) , and GFR ( 11 % , p < 0.05 , vs 4 % , p = NS ; p = NS for change with rosuvastatin treatment vs change with no antilipemic treatment )",
"AIMS Previously we revealed the effectiveness of a new therapeutic approach with a short-term , very-low dose fluvastatin-valsartan combination on the improvement of arterial function in type 1 diabetes mellitus patients ( T1DM ) . In this study we explored whether this approach influences inflammation and oxidative stress and explored any association of these effects with arterial function improvement . METHODS This was a supplementary analysis of the two previous double blind r and omized studies ( included 44 T1DM patients ) . Treatment group received very-low dose fluvastatin-valsartan , the control group received placebo . Blood sample s were collected and inflammation parameters : high-sensitivity CRP ( hsCRP ) , interleukin 6 ( IL-6 ) , vascular cell adhesion molecule-1 ( VCAM-1 ) and oxidative stress parameter total antioxidant status ( TAS ) were measured . RESULTS Treatment decreased hsCRP values ( by 56.5 % , P and IL-6 values ( by 33.6 % , P increased TAS values ( by 21.1 % ; P High sensitivity CRP and TAS remained decreased 3months after treatment discontinuation . Importantly , the anti-inflammatory and anti-oxidative action significantly correlated with arterial function improvement . CONCLUSIONS The approach consisting of short-term ( 30days ) treatment with a very low-dose fluvastatin-valsartan combination acts anti-inflammatory and anti-oxidative in T1DM patients . These observations along with the improvement of arterial function support the assumption that this approach could have an important clinical benefit in T1DM patients",
"OBJECTIVE The purpose of this study was to evaluate the efficacy and safety profile of ezetimibe/simvastatin(EZE/SIMVA ) combination tablet , relative to ezetimibe ( EZE ) and simvastatin ( SIMVA ) monotherapy , in patients with primary hypercholesterolemia . METHODS This was a r and omized , multicenter , double-blind , placebo-controlled , factorial design study After a 6- to 8-week washout period and 4-week , single-blind , placebo run in , hypercholesterolemic patients ( low-density lipoprotein cholesterol [ LDL-C ] , 145 - 250 mg/dL ; triglycerides [ TG ] , were r and omized equally to 1 of 10 daily treatments for 12 weeks : EZE/SIMVA 10/10 , 10/20 , 10/40 , or 10/80 mg ; SIMVA 10 , 20 , 40 , or 80 mg ; EZE 10 mg ; or placebo . The primary efficacy analysis was mean percent change from baseline in LDL-C to study end point Secondary end points included percent changes in other lipid variables and C-reactive protein [ CRP ] . RESULTS There were 1528 patients r and omized to treatment ( 792 women , 736 men ) ; mean ( SD ) age ranged from 54.9 ( 112 ) years to 56.4 ( 10.6 ) years across pooled treatment groups . The treatment groups were well balanced for baseline demographics . Pooled EZE/SIMVA was associated with greater reductions in LDL-C than pooled SIMVA or EZE alone ( P EZE/SIMVA was associated with reductions in LDL-C of -44.8 % to -602 % , non-high-density lipoprotein cholesterol of -40.5 % to -55.7 % , and TG of -22.5 % to -30.7 % ; high-density lipoprotein cholesterol increased by 5.5 % to 9.8 % . EZE/SIMVA was associated with greater reductions in CRP and remnant-like particle-cholesterol than SIMVA alone ( P EZE/SIMVA versus SIMVA achieved LDL-C concentrations EZE/SIMVA was generally well tolerated , with a safety profile similar to SIMVA monotherapy There were no significant differences between EZE/SIMVA and SIMVA in the incidence of consecutive liver transaminase levels > or =3 times the upper limit of normal ( ULN ) ( 1 .5 % for EZE/SIMVA and 1.1 % for SIMVA ; P = NS ) or creature kinase levels > or = 10 times ULN ( 0.0 % for EZE/SIMVA and 02 % for SIMVA ; P = NS ) . CONCLUSION The EZE/SIMVA tablet was a highly effective and well-tolerated LDL-C-lowering therapy in this study of patients with primary hypercholesterolemia",
"BACKGROUND Chronic kidney disease ( CKD ) is associated with inflammation . The effects of atorvastatin on biomarkers of inflammation were assessed in CKD patients in the LORD trial . METHODS 117 patients with serum creatinine > 120 μmol/L were r and omized to receive atorvastatin 10 mg/day ( 56 ) or placebo ( 61 ) and followed for a mean of 2.5 years . 33 individuals with normal kidney function were controls . Outcomes included comparison of changes in pentraxin-3 ( PTX3 ) , TNF-α , CRP , IL-6 , IL-8 , and IL-10 between atorvastatin and placebo-treated patients . RESULTS At baseline , compared with controls , CKD patients had increased PTX3 ( mean , 1.08 vs. 0.58 ng/mL ; p IL-8 ( 6.00 vs. 4.58 pg/mL ; p = 0.001 ) , IL-10 ( 59.0 vs. 17.6 pg/mL ; p = 0.007 ) , and TNF-α ( 18.0 vs. 5.6 ng/mL ; p baseline plasma IL-6/8/10 and /or PTX3 the eGFR decline during the trial was significantly less in those treated with atorvastatin compared to placebo ( mean change , -3.36 ; vs. + 1.25 mL/min/1.73 m2/year ; difference , 4.61 95 % CI 0.98 - 8.25 ; p = 0.002 ) , whilst those without raised inflammatory biomarkers showed no difference . Placebo treated patients with raised TNF-α levels had no eGFR decline ( p > 0.90 ) , whereas in atorvastatin-treated patients eGFR declined ( p = 0.05 ) . CONCLUSIONS CKD patients with inflammation treated with atorvastatin had significantly less eGFR decline . Larger studies using statin therapy , specifically enrolling CKD patients with inflammation , may be worthwhile exploring",
"Purpose of the study was to investigate whether short-term atorvastatin treatment improves endothelial function and affects inflammatory process in patients with heart failure ( HF ) and normal cholesterol levels . HF is characterized by endothelial dysfunction and increased inflammatory process , while statins restore endothelial function having also anti-inflammatory effects in hypercholesterolemic patients . We investigated the effect of 4-week atorvastatin treatment ( 10 mg/day ) on endothelial function and inflammatory markers in patients with HF and cholesterol levels into groups and received atorvastatin ( n=19 ) or no statin ( n=19 ) . Forearm blood flow was measured using gauge-strain plethysmography . Serum levels of tumor necrosis factor alpha ( TNF-alpha ) , interleukin 6 ( IL-6 ) , and soluble vascular cell adhesion molecule ( sVCAM-1 ) were determined with ELISA . Data are expressed as median [ 25th-75th percentile ] . Forearm vasodilatory response to reactive hyperemia was significantly improved in atorvastatin-treated patients ( from 38.1 % [ 32.0 - 59.1 ] to 70.0 % [ 61.1 - 106.3 ] , P Levels of IL-6 , TNF-alpha and sVCAM-1 were decreased in atorvastatin-treated group ( from 7.8 pg/ml [ 4.8 - 9.5 ] , 3.2 pg/ml [ 2.7 - 4.8 ] and 595 ng/ml [ 440 - 810 ] to 5.6 pg/ml [ 2.5 - 9.0 ] , 2.8 pg/ml [ 2.0 - 3.6 ] and 289 ng/ml [ 169 - 368 ] , respectively , P vasodilatory response to reactive hyperemia and depress inflammatory process in patients with heart failure and normal baseline cholesterol levels",
"Background —Inflammation promotes acute coronary syndromes and ensuing clinical complications . Although statins reduce inflammatory markers in asymptomatic adults or in patients with stable angina , the effect of statins on the markedly heightened inflammation in patients with acute coronary syndromes is unknown . Methods and Results —We measured C-reactive protein ( CRP ) , serum amyloid A ( SAA ) , and interleukin 6 ( IL-6 ) in 2402 subjects enrolled the Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering ( MIRACL ) study . Subjects with unstable angina or non – Q-wave myocardial infa rct ion were r and omized to atorvastatin 80 mg/d or placebo within 24 to 96 hours of hospital admission and treated for 16 weeks . The effect of treatment on inflammatory markers was assessed by ANCOVA after adjustment for presenting syndrome , country , and initial level of marker . All 3 markers were markedly elevated at r and omization and declined over the 16 weeks in both treatment groups . Compared with placebo , atorvastatin significantly reduced CRP , −83 % ( 95 % CI , −84 % , −81 % ) versus −74 % ( 95 % CI , −75 % , −71 % ) ( P , −80 % ( 95 % CI , −82 % , −78 % ) versus −77 % ( −79 % , −75 % ) ( P = 0.0006 ) but not IL-6 , −55 % ( 95 % CI , −57 % , −53 % ) versus −53 % ( 95 % CI , −55 % , −51 % ) ( P = 0.3 ) . Reductions in CRP and SAA were observed in patients with unstable angina and non – Q-wave myocardial infa rct ion , with initial LDL cholesterol and in men and women . By 16 weeks , CRP was 34 % lower with atorvastatin than with placebo . Conclusions —High-dose atorvastatin potentiated the decline in inflammation in patients with acute coronary syndromes . This supports the value of early statin therapy in these patients",
"We sought to determine if atorvastatin lowers blood pressure in patients with previously diagnosed and well-controlled essential arterial hypertension and if this effect could be related to anti-inflammatory and anti-oxidative effects . Among 92 patients with essential arterial hypertension , we studied 56 non-smoking and normolipemic : 39 were r and omized to receive 80 mg atorvastatin daily for 3 months ( statin-treated patients , ST ) , and the rest continued a previous hypotensive therapy ( statin-free patients , SF ) . Blood pressure was measured using a 24-h ambulatory blood pressure measurement device . Serum levels of high-sensitivity C-reactive protein ( hs-CRP ) , total antioxidant status ( TAS ) and plasma peroxides ( assessed by Oxystat ) were measured in both groups . The mean change in systolic BP ( SBP ) for atorvastatin was -5.7 mmHg ( 95 % confidence interval CI , -4.1 to -7.2 mmHg ) , and the mean change in diastolic BP ( DBP ) was -3.9 mmHg ( 95 % CI , -2.7 to -5.0 mmHg ) . No change in BP in SF patients was observed . In the ST group , hs-CRP and peroxides did not significantly decrease . In the SF group , concentrations of hs-CRP proceeded to decrease while peroxides increased . In the ST group , changes in hs-CRP correlated with changes in total cholesterol and low-density lipoprotein cholesterol ( r = 0.41 , p = 0.013 and r = 0.35 , p = 0.04 , respectively ) but did not correlate with changes in BP . The hypotensive statin effect was independent of the hypolipemic effect . During three months of observation , TAS concentrations in both groups remained stable . In this r and omized study , additionally administered atorvastatin to non-smoking and normolipemic patients with well-controlled essential arterial hypertension result ed in reduction of BP . This effect was not followed by significant changes in hs-CRP , TAS or Oxystat concentrations . The hypotensive effect of atorvastatin did not depend on anti-inflammatory , anti-oxidative or hypolipemic actions",
"OBJECTIVES We investigated whether atorvastatin might decrease insulin sensitivity and increase ambient glycemia in hypercholesterolemic patients . BACKGROUND Clinical trials suggest that some statin treatments might increase the incidence of diabetes despite reductions in low-density lipoprotein ( LDL ) cholesterol and improvement in endothelial dysfunction . METHODS A r and omized , single-blind , placebo-controlled parallel study was conducted in 44 patients taking placebo and in 42 , 44 , 43 , and 40 patients given daily atorvastatin 10 , 20 , 40 , and 80 mg , respectively , during a 2-month treatment period . RESULTS Atorvastatin 10 , 20 , 40 , and 80 mg significantly reduced LDL cholesterol ( 39 % , 47 % , 52 % , and 56 % , respectively ) and apolipoprotein B levels ( 33 % , 37 % , 42 % , and 46 % , respectively ) after 2 months of therapy when compared with either baseline ( all p fasting plasma insulin ( mean changes : 25 % , 42 % , 31 % , and 45 % , respectively ) and glycated hemoglobin levels ( 2 % , 5 % , 5 % , and 5 % , respectively ) when compared with either baseline ( all p insulin sensitivity ( 1 % , 3 % , 3 % , and 4 % , respectively ) when compared with either baseline ( p = 0.312 , p = 0.008 , p fasting insulin and glycated hemoglobin levels consistent with insulin resistance and increased ambient glycemia in hypercholesterolemic patients . ( Effects of Atorvastatin on Adiponectin Levels and Insulin Sensitivity In Hypercholesterolemic Patients ; NCT00745836 )",
" The aim of our study was to evaluate whether a single dose of cerivastatin at the time of admission of patients with unstable angina pectoris ( UAP ) or non-Q-wave myocardial infa rct ion ( NQMI ) can influence the serum level of C-reactive protein ( CRP ) , interleukin-6 ( IL-6 ) and interleukin-8 ( IL-8 ) 24 h later . Forty-four patients with rest chest pain and subendocardial ischemia on ECG were r and omized to receive cerivastatin 0.3 mg at the time of admission ( group C+ ) to st and ard therapy or to remain just on st and ard therapy ( group C− ) . Blood sample s for determination of troponin I ( TI ) , CRP , IL-6 and IL-8 were collected at admission ( entry level ) and 24 h later ( final level ) . Patients with non-physiological baseline levels of TI , as well as patients with progression to Q wave MI were excluded . All baseline , clinical and demographic data and final values of TI were comparable in the two groups . In patients treated with cerivastatin ( group C+ , n = 13 ) we observed decrease in the CRP level ( −6.73 ± 3.93 mg/L ) ; on the other h and , in group C− ( n = 17 ) the CRP level increased ( + 7.92 ± 2.77 mg/L , p = 0.004 ) . Similar differences were observed also in IL-6 : in group C+ the level was significantly reduced as compared with the increase in group C− ( −0.76 ± 0.52 vs. 4.58 ± 1.49 ng/L , p = 0.005 ) . The level of IL-8 was not affected . Our results suggest that early treatment with cerivastatin can decrease the serum level of CRP and IL-6 in patients with UAP/NQMI ; this might positively influence their prognosis . Nevertheless , further studies are needed to support this hypothesis",
" This study assessed the effects of tirofiban and statins on high-sensitivity C-reactive protein , interleukin-6 , and soluble CD40 lig and after percutaneous coronary intervention in patients who had stable coronary artery disease . Tirofiban insignificantly limited the increase of soluble CD40 lig and after revascularization , especially in patients who had high levels of this marker at baseline ( p = 0.06 ) , whereas statins significantly inhibited increases in interleukin-6 and , to a lesser extent , high-sensitivity C-reactive protein without affecting the soluble CD40 lig and",
"BACKGROUND Elevated levels of C-reactive protein , even in the absence of hyperlipidemia , are associated with an increased risk of coronary events . Statin therapy reduces the level of C-reactive protein independently of its effect on lipid levels . We hypothesized that statins might prevent coronary events in persons with elevated C-reactive protein levels who did not have overt hyperlipidemia . METHODS The level of C-reactive protein was measured at base line and after one year in 5742 participants in a five-year r and omized trial of lovastatin for the primary prevention of acute coronary events . RESULTS The rates of coronary events increased significantly with increases in the base-line levels of C-reactive protein . Lovastatin therapy reduced the C-reactive protein level by 14.8 percent ( P lovastatin-induced changes in the lipid profile . As expected , lovastatin was effective in preventing coronary events in participants whose base-line ratio of total cholesterol to high-density lipoprotein ( HDL ) cholesterol was higher than the median ratio , regardless of the level of C-reactive protein ( number needed to treat for five years to prevent 1 event , 47 ; P=0.005 ) . However , lovastatin was also effective among those with a ratio of total to HDL cholesterol that was lower than the median and a C-reactive protein level higher than the median ( number needed to treat , 43 ; P=0.02 ) . In contrast , lovastatin was ineffective among participants with a ratio of total to HDL cholesterol and a C-reactive protein level that were both lower than the median ( number needed to treat , 983 ; P=0.80 ) . CONCLUSIONS Statin therapy may be effective in the primary prevention of coronary events among subjects with relatively low lipid levels but with elevated levels of C-reactive protein",
"Background Insulin resistance is associated with the progression of atherosclerosis and is reported to predict cardiovascular mortality in patients with end-stage renal disease ( ESRD ) . Although statins exert pleiotropic effects , it is uncertain whether statin therapy improves insulin resistance in these patients . In this prospect i ve r and omized controlled trial , we aim ed to evaluate the effects of statin on insulin resistance among 70 patients undergoing peritoneal dialysis ( PD ) . Methods Patients were r and omized into a statin group ( n = 35 ) or a control group ( n = 35 ) . The statin group received 10 mg per day of rosuvastatin for 6 months . We determined insulin resistance by homeostatic model assessment of insulin resistance ( HOMA-IR ) index . Serum concentrations of adipokines such as adiponectin , leptin , and resistin were measured using enzyme-linked immunosorbent ( ELISA ) assay . As inflammatory markers , high sensitive C-reactive protein ( hsCRP ) and interleukin-6 were also measured . Results There were no significant differences in baseline characteristics between the two groups . Compared to baseline value , statin treatment significantly decreased HOMA-IR index from 2.37 ± 1.08 to 2.05 ± 0.82 ( P = 0.014 ) . There was a concordant decrease in hsCRP levels in the statin group ( 2.05 ± 1.57 to 1.21 ± 0.84 mg/L , P , hsCRP levels were more decreased in the statin group than in the control group ( P = 0.021 for between-group difference ) , whereas HOMA-IR index was not ( P = 0.189 for between-group difference ) . During this period , statin treatment did not result in the improved adipokine profiles . Conclusion This study showed that statin therapy failed to improve insulin resistance in PD patients despite a significant decline in hsCRP levels after statin treatment . Our finding suggests that reducing inflammation by statin is of limited help to fully attenuate insulin resistance in these patients",
"Abstract Statins have beneficial effects on cerebral circulation and brain parenchyma during ischemic stroke and reperfusion . The primary hypothesis of this r and omized parallel trial was that treatment with 80 mg/day of atorvastatin administered early at admission after acute atherosclerotic ischemic stroke could reduce serum levels of markers of immune-inflammatory activation of the acute phase and that this immune-inflammatory modulation could have a possible effect on prognosis of ischemic stroke evaluated by some outcome indicators . We enrolled 42 patients with acute ischemic stroke classified as large arteries atherosclerosis stroke ( LAAS ) r and omly assigned in a r and omized parallel trial to the following groups : Group A , 22 patients treated with atorvastatin 80 mg ( once-daily ) from admission day until discharge ; Group B , 20 patients not treated with atorvastatin 80 mg until discharge , and after discharge , treatment with atorvastatin has been started . At 72 hours and at 7 days after acute ischemic stroke , subjects of group A showed significantly lower plasma levels of tumor necrosis factor-&agr ; , interleukin (IL)-6 , vascular cell adhesion molecule-1 , whereas no significant difference with regard to plasma levels of IL-10 , E-Selectin , and P-Selectin was observed between the 2 groups . At 72 hours and 7 days after admission , stroke patients treated with atorvastatin 80 mg in comparison with stroke subjects not treated with atorvastatin showed a significantly lower mean National Institutes of Health Stroke Scale and modified Rankin scores . Our findings provide the first evidence that atorvastatin acutely administered immediately after an atherosclerotic ischemic stroke exerts a lowering effect on immune-inflammatory activation of the acute phase of stroke and that its early use is associated to a better functional and prognostic profile",
"Elevated plasma levels of asymmetric dimethylarginine ( ADMA ) have been associated with attenuated endothelium-dependent vasodilation in hypercholesterolemic patients . However , whether lowering of plasma cholesterol concentration by hydroxymethylglutaryl coenzyme A reductase inhibitors ( statins ) can reduce plasma ADMA levels is still not clear . This study was a multicenter , r and omized , double-blind , placebo-controlled design including 46 patients with elevated low-density lipoprotein cholesterol levels . Patients were r and omized into 2 groups : rosuvastatin 10 mg/day and placebo for 6 weeks . Plasma levels of ADMA , 8-isoprostane ( as a marker of oxidative stress ) , homocysteine , and high-sensitivity C-reactive protein were measured at baseline and 6 weeks later . Endothelial function assessed by flow-mediated vasodilation of the brachial artery was performed in 11 patients in the rosuvastatin group and in 12 in the placebo group . Baseline characteristics of both groups were similar , and the plasma ADMA levels were significantly correlated with 8-isoprostane ( r = 0.388 , p = 0.008 ) . After 6 weeks of treatment , plasma ADMA levels were significantly reduced in the rosuvastatin group ( from 0.60 + /- 0.19 to 0.49 + /- 0.10 micromol/L , p flow-mediated vasodilation were positively correlated with reductions in plasma levels of ADMA ( p = 0.017 ) and low-density lipoprotein cholesterol ( p rosuvastatin in patients with hypercholesterolemia may lead to a significant reduction in plasma ADMA levels , which appear to be related to the improvement in endothelial function by rosuvastatin",
"BACKGROUND Studies indicate that myeloperoxidase ( MPO ) is associated with disease progression and severity in heart failure ( HF ) , while it may provide a mechanistic link between inflammation and adverse cardiac remodeling . The mechanisms that regulate MPO are unclear , while it is unknown whether specific treatments such as HMG-CoA reductase inhibitors and xanthine oxidase inhibitors may modify MPO . Therefore in the present study we examined the effects of rosuvastatin and allopurinol on MPO levels in patients HF . METHODS Sixty clinical ly stable patients with systolic HF were r and omized to receive rosuvastatin 10mg/day , allopurinol 300mg/day or placebo and followed up for 1 month . Plasma levels of MPO and serum levels of soluble CD40 lig and , interleukin-6 , and oxidized LDL were determined using ELISA . All measurements were made before and after 1-month treatment . RESULTS Rosuvastatin significantly reduced plasma levels of MPO ( p=0.003 ) , which remained unchanged in the other groups . Furthermore , the change of MPO levels in the rosuvastatin-treated group was significantly different compared with the other groups ( p Rosuvastatin administration also led to a significant decrease in oxidized LDL ( p=0.009 ) , while the other inflammatory markers remained unchanged in all groups . In the total population , a significant correlation was observed between the baseline levels of MPO and hsCRP ( r=0.275 , p=0.027 ) , fibrinogen ( r=0.278 , p=0.025 ) , and sCD40L ( r=0.288 , p=0.021 ) . CONCLUSIONS Short-term treatment with rosuvastatin regulates inflammatory process in patients with heart failure by significantly reducing plasma levels of MPO . This finding reveals a novel pleiotropic effect of statins in patients with heart failure , and provides further insights into the pathophysiological mechanisms of MPO in heart failure",
"BACKGROUND It has been shown that many women with polycystic ovary syndrome ( PCOS ) are 25-hydroxyvitamin D ( 25OHD ) insufficient . Both statin treatment and vitamin D supplementation have been shown to improve biochemical hyper and rogenemia , insulin resistance , and markers of inflammation in patients with PCOS , raising the possibility that some of the statin effects are mediated through vitamin D. METHODS We conducted this r and omized , double-blind placebo controlled study to assess the effect of atorvastatin on serum 25OHD concentrations in patients with PCOS . Forty medication-naive patients with PCOS were r and omized to either atorvastatin 20 mg daily or placebo for 3 months . After completing the initial 3 months of atorvastatin or placebo , both groups of patients participated in a 3-month extension study with metformin 1500 mg daily . We measured changes in 25OHD concentrations by use of t and em mass spectrometry . RESULTS Mean ( SD ) baseline 25OHD concentrations were comparable between the 2 groups [ 45.9 ( 2.4 ) vs 44.8 ( 1.8 ) nmol/L ; P = 0.7 ] . There was a significant increase in 25OHD concentrations with atorvastatin [ 45.9 ( 2.4 ) vs 60.8 ( 3.5 ) nmol/L ] compared with placebo [ 44.8 ( 1.8 ) vs 41.8 ( 3.2 ) nmol/L ; P = 0.02 ] . Three-month treatment with metformin maintained the improvement of 25OHD with atorvastatin compared to baseline [ 45.9 ( 2.4 ) vs 61.8 ( 3.5 ) , P ≤ 0.01 ) . There were no significant changes in 25OHD concentrations in the placebo group after 12 weeks of metformin . CONCLUSIONS Among patients with polycystic ovary syndrome , 12 weeks of atorvastatin led to a clinical ly significant rise in 25OHD concentrations . This may represent a beneficial pleiotropic effect of statins on 25OHD concentrations",
"CONTEXT Statins have been shown to improve hyper and rogenism in women with polycystic ovary syndrome ( PCOS ) . However , their use has also been associated with impairment of glucose metabolism and an increased risk of type 2 diabetes mellitus . Because women with PCOS are prone to disturbances in glucose metabolism , statin therapy could also have negative effects . OBJECTIVE Our objective was to explore the effects of atorvastatin therapy on hormonal and metabolic parameters in women with PCOS . DESIGN AND SETTING We conducted a r and omized , double-blind , placebo-controlled 6-month follow-up study conducted at Oulu University Hospital , Finl and . PATIENTS Women with PCOS ( Rotterdam criteria ) were treated with atorvastatin ( 20 mg/d , n = 15 ) or placebo ( n = 13 ) for 6 months . INTERVENTIONS Fasting serum sample s were collected at baseline and at 3 and 6 months . Oral and iv glucose tolerance tests were performed at 0 and 6 months . MAIN OUTCOME MEASURES And rogen secretion and glucose metabolism were measured . RESULTS Fasting levels and area under the curve of insulin increased significantly and insulin sensitivity ( insulinogenic and Matsuda indexes ) decreased during 6 months of atorvastatin therapy . Serum levels of dehydroepi and rosterone sulfate decreased in the atorvastatin group , whereas no change was observed in serum testosterone levels . Levels of C-reactive protein , total and low-density lipoprotein-cholesterol , and triglycerides decreased significantly during statin therapy . CONCLUSIONS Atorvastatin therapy improves chronic inflammation and lipid profile , but it impairs insulin sensitivity in women with PCOS . Because women with PCOS have an increased risk of developing type 2 diabetes mellitus , the results suggest that statin therapy should be initiated on the basis of generally accepted criteria and individual risk assessment of cardiovascular disease , and not only because of PCOS",
"Background : Telomerase activity ( TA ) is considered as the biomarker for cardiovascular aging and cardiovascular diseases ( CVDs ) . Recent studies suggest a link between statins and telomere biology that may be explained by anti-inflammatory actions of statins and their positive effect on TA . Until now , this effect has not been investigated in prospect i ve r and omized studies . We hypothesized that 12 months of atorvastatin therapy increased TA in peripheral blood mononuclear cells . Methods : In a r and omized , placebo-controlled study 100 hypercholesterolemic patients , aged 35–75 years , free of known CVDs and diabetes mellitus type 2 received 20 mg of atorvastatin daily or placebo for 12 months . TA was measured by quantitative polymerase chain reaction . Results : At study end , 82 patients had sufficient peripheral blood mononuclear cells needed for longitudinal analysis . TA expressed as natural logarithms changed from 0.46 ± 0.05 to 0.68 ± 0.06 ( p = 0.004 ) in the atorvastatin group and from 0.67 ± 0.06 to 0.60 ± 0.07 ( p = 0.477 ) in the control group . In multiple regression analysis , atorvastatin therapy was the only independent predictor ( p = 0.05 ) of the changes in TA independently of markers of chronic inflammation and oxidative stress . Atorvastatin therapy was associated with increases in interleukin-6 within the normal range and a tendency toward reduction in blood urea . Conclusion : These initial observations suggest atorvastatin can act as telomerase activator and potentially as effective geroprotector . Trial registration : The trial was registered in IS RCT N registry IS RCT N55050065",
"BACKGROUND The role of statin therapy in heart failure ( HF ) is unclear . The amino-terminal propeptide of procollagen type III ( PIIINP ) predicts outcome in HF , and yet there are conflicting reports of statin therapy effects on PIIINP . OBJECTIVES This study determined whether there was an increase in serum markers of inflammation , fibrosis ( including PIIINP ) , and B-type natriuretic peptide ( BNP ) in patients with systolic HF and normal total cholesterol and determined the effects of long-term treatment with atorvastatin on these markers . METHODS Fifty-six white patients with systolic HF and normal cholesterol levels ( age 72 [ 13 ] years ; 68 % male ; body mass index 27.0 [ 7.3 ] kg/m(2 ) ; ejection fraction 35 [13]% ; 46 % with history of smoking ) were r and omly allocated to atorvastatin treatment for 6 months , titrated to 40 mg/d ( A group ) or not ( C group ) . Age- and /or sex-matched subjects without HF ( N group ) were also recruited . Biomarkers were measured at baseline ( all groups ) and 6 months ( A and C groups ) . RESULTS Serum markers of collagen turnover , inflammation , and BNP were significantly elevated in HF patients compared with normal participants ( all P Atorvastatin treatment for 6 months caused a significant reduction in the following biomarkers compared with baseline : BNP , from median ( interquartile range ) 268 ( 190 - 441 ) pg/mL to 185 ( 144 - 344 ) pg/mL ; high-sensitivity C-reactive protein ( hs-CRP ) , from 5.26 ( 1.95 -9.29 ) mg/L to 3.70 ( 2.34 - 6.81 ) mg/L ; and PIIINP , from 4.65 ( 1.86 ) to 4.09 ( 1.25 ) pg/mL ( all P baseline hs-CRP and PIIINP ( P Long-term statin therapy reduced PIIINP in this small , selected HF population with elevated baseline levels . Further evaluation of statin therapy in the management of HF patients with elevated PIIINP is warranted",
"BACKGROUND High-dose statins are used in acute coronary syndromes ( ACS ) to reduce inflammation . The aim of the study was the evaluation of the influence of low-dose atorvastatin ( 20 mg ) on selected inflammatory parameters and clinical outcomes after ACS . METHODS Seventy eight patients ( pts ) with ACS were r and omly divided into group A ( 39 pts ) taking atorvastatin , and group NA ( 39 pts ) not taking any statin for the following six weeks . C-reactive protein ( CRP ) , interleukin-6 ( IL-6 ) , monocyte chemoattractant protein-1 ( MCP-1 ) and tumour necrosis factor alpha ( TNFa ) levels were measured on the first and the fifth days and six weeks after ACS . RESULTS There was no significant CRP and IL-6 level decrease in group A ( CRP--62 % ; IL-6 - 73 % ) or group NA ( CRP-44 % ; IL-6 - 62 % ) . There was also no significant change in TNFa levels . The MCP-1 level finally reached the level of significant difference ( p Cardiovascular events ( MACE ) and the restenosis rates did not differ between the groups . CONCLUSIONS Low-dose atorvastatin does not have a significant influence on cooling down inflammation in ACS , and MCP-1 can be used as an early indicator of statin anti-inflammatory activity . Furthermore , it does not reduce MACE or restenosis rates despite its influence on MCP-1 levels",
"BACKGROUND Lipid-lowering agents are known to reduce long-term mortality in patients with stable angina or multiple risk factors . However , the effects of lipid-lowering treatment on inflammatory process during and immediately after the acute phase of unstable angina remain unclear . In this study we assessed the effects of low-dose atorvastatin treatment , on inflammatory process in patients admitted for unstable angina with low cholesterol level . METHODS Forty-seven normocholesterolemic patients with unstable angina were r and omized into two groups , and received atorvastatin 10 mg/day ( n = 24 ) or no statin ( n = 23 ) for 6 weeks . Circulating levels of inteleukin 6 ( IL-6 ) , monocyte chemoattractant protein-1 ( MCP-1 ) , tumor necrosis factor alpha ( TNF-alpha ) and soluble vascular cell adhesion molecule ( sVCAM-1 ) were measured by their admission , and at the 1st and 6th week of the study . RESULTS Serum levels of MCP-1 and sVCAM-1 were significantly increased in the control group ( p IL-6 and TNF-alpha levels were similarly decreased in both atorvastatin-treated and control groups . CONCLUSION Low-dose atorvastatin treatment modifies inflammatory process in patients with unstable angina and low cholesterol level , an effect seen at 6 weeks but not 1 week after admission",
"AIM We aim ed to assess the effects of rosuvastatin treatment on lipid levels , a biomarker of oxidative stress , albuminuria , and kidney function in patients with diabetic nephropathy . METHODS We conducted a prospect i ve , open-label , parallel group , controlled study of 104 patients with diabetic nephropathy , low-density lipoprotein cholesterol ( LDL-C ) levels of > 120 mg/dL , and well-controlled blood pressure who were undergoing treatment with renin angiotensin system inhibitors . Patients were r and omly assigned to two groups : the rosuvastatin group ( n = 52 ; 2.5 mg/day rosuvastatin , increased to 10 mg/day ) and the control group ( n = 52 ; no rosuvastatin administered ) . We determined the efficacy of rosuvastatin by monitoring serum lipid profiles , high sensitivity C-reactive protein ( hs-CRP ) , malondialdehyde-modified LDL ( MDA-LDL ) , and cystatin C levels . In addition , urinary albumin , 8-hydroxydeoxyguanosine ( 8-OHdG ) and liver-type fatty acid-binding protein ( L-FABP ) levels were measured before and 6 months after rosuvastatin was added to the treatment . RESULTS Rosuvastatin effectively reduced total cholesterol , LDL-C , triglycerides , non-high-density lipoprotein cholesterol ( non-HDL-C ) levels , and the LDL-C/ HDL-C ratio in the rosuvastatin group . These parameters remained unchanged in patients who were not treated with rosuvastatin . Although there was no significant change in the estimated glomerular filtration rate level , serum cystatin C levels and urinary albumin excretion rates were significantly decreased in the rosuvastatin group . In addition , rosuvastatin significantly reduced hs-CRP and MDA-LDL levels . Moreover , urinary 8-OHdG and L-FABP levels at baseline ( 13.5±5.1 and 41.7±26.1 ng/mgCr , respectively ) decreased significantly at 6 months ( 11.5±4.0 and 26.9±13.4 ng/mgCr , respectively ) , and there was a significant correlation ( r = 0.48 , p albuminuria was significantly correlated with only rosuvastatin use ( p = 0.0006 , R(2)= 0.53 ) . CONCLUSION Rosuvastatin administration reduced albuminuria , oxidative stress , and serum cystatin C levels , independent of blood pressure and lipid levels",
"Our aim in this study was to investigate the changes of serum high-sensitive C-reactive protein ( hs-CRP ) and uric acid ( UA ) , and evaluate the synergistic effect of amlodipine and atorvastatin on blood pressure and left ventricular remodeling in hypertensive patients with primary hypercholesterolemia . One hundred and twenty-six hypertensive patients with hypercholesterolemia were r and omized into amlodipine group ( 10 mg/day , group A , n = 65 ) and amlodipine ( 10 mg/day ) plus atorvastatin group ( 20 mg/day , group B , n = 61 ) , treated for 4 months continuously . Serum concentrations of total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , triglycerides , hs-CRP , and UA were determined , and blood pressure of both groups was examined before and after treatment . Left ventricular posterior wall thickness and interventricular spectum thickness were measured by echocardiography , and left ventricular mass index ( LVMI ) was calculated . After 4-months of treatment with atorvastatin , serum concentrations of total cholesterol , low-density lipoprotein cholesterol , triglycerides , hs-CRP , and UA were significantly decreased in group B ( P serum concentrations of high-density lipoprotein cholesterol was elevated ( P systolic blood pressure and diastolic blood pressure were reduced in both groups ( P LVMI in both groups decreased ( P Atorvastatin can decrease serum concentrations of hs-CRP and UA . The amlodipine-atorvastatin combination markedly reduces blood pressure and reverses left ventricular hypertrophy more than amlodipine monotherapy . The positive effect suggests that in hypertensive and hypercholesterolemic patients , the combination of amlodipine and atorvastatin could be the treatment of choice",
"OBJECTIVE Lowering LDL-cholesterol by statins has been proven to be associated with reduction of proinflammatory regulators e.g. activation of the transcription factor NF-κB. To our knowledge , anti-inflammatory potential of newer cholesterol lowering agents such as ezetimibe is less intensively studied . Therefore we analyzed the effects of equipotent LDL-lowering therapy with simvastatin alone compared to a combination with ezetimibe on NF-κB activation in peripheral blood mononuclear cells ( P BMC s ) of patients with type 2 diabetes . METHODS Thirty-one patients with type 2 diabetes were included in a double-blind , r and omized trial receiving either 80 mg simvastatin ( sim80 ; n = 10 ) or a combination of 10 mg simvastatin and 10 mg ezetimibe ( sim10eze10 ; n = 11 ) or placebo ( n = 9 ) for eight weeks . NF-κB binding activity and inflammatory markers ( IL-6 , hsCRP ) were analyzed at baseline and after eight weeks of treatment . NF-κB binding activity was analyzed by electrophoretic mobility shift assay . IL-6 and hsCRP were measured by ELISA . RESULTS After eight weeks of treatment LDL-cholesterol was lowered to the same extent in both treatment groups ( p = 0.40 ) but not in placebo . However , patients taking sim80 showed a significant reduction of mononuclear NF-κB binding activity compared to baseline ( p = 0.009 ) while no effect was observed in the sim10eze10 group ( p = 0.79 ) . Similar differences in anti-inflammatory effects were also observed when analyzing hsCRP ( sim80 : p = 0.03 ; sim10eze10 : p = 0.40 ) and IL-6 levels ( sim80 : p = 0.15 ; sim10eze10 : p = 0.95 ) . CONCLUSION High dose simvastatin therapy reduces proinflammatory transcription factor NF-κB binding activity and hsCRP levels , while combination of low dose simvastatin with ezetimibe result ing in a similar LDL-reduction does not affect these inflammatory markers",
"BACKGROUND Statin therapy prior to percutaneous coronary intervention ( PCI ) is associated with reduced mortality and periprocedural myocardial injury after PCI . We studied whether single high dose statin loading is beneficial on the outcome of patients with acute coronary syndrome ( ACS ) underwent PCI . METHODS Consecutive 445 patients with ACS who underwent PCI were r and omly assigned to either the group of no statin treatment before PCI ( Control group : n=220 , 63+/-11 years , male 62 % ) or the group of 40 mg rosuvastatin loading before PCI ( Rosuvastatin group : n=225 , 64+/-10 years , male 60 % ) . Incidence of periprocedural myocardial injury was assessed by analysis of creatinine kinase-MB ( CK-MB ) and cardiac troponin T before PCI , at 6 h and the next morning after PCI . RESULT There were no significant differences in clinical characteristics between the two groups . After PCI , incidence of periprocedural myocardial injury was higher in control than in rosuvastatin group ( 11.4 % versus 5.8 % , p=0.035 ) . Mean preprocedural CK-MB and high sensitivity C-reactive protein were similar between the two groups , whereas after PCI , peak values of both markers were elevated significantly higher in control than in rosuvastatin group . Multivariate analysis revealed that no prior use of statin ( OR=2.2 ; 95 % CI=1.1 - 4.6 ; p=0.029 ) , procedural complication ( OR=3.1 ; 95 % CI=1.4 - 6.9 ; p=0.007 ) and multi-vessel disease ( OR=2.6 ; 95 % CI=1.0 - 6.6 ; p=0.039 ) were the independent predictors for periprocedural myocardial infa rct ion . CONCLUSION Single high dose of rosuvastatin prior to PCI reduces periprocedural myocardial injury in patients with ACS",
"BACKGROUND Chronic low- grade inflammation may contribute to the increased risk of atherosclerosis in visceral obesity . Statin and fish oil have been reported to have antiinflammatory effects . We studied whether dyslipidemic , obese individuals have increased plasma high-sensitivity C-reactive protein ( hs-CRP ) concentrations and whether treatment with atorvastatin and fish oil lowered plasma hs-CRP concentrations . METHODS We compared plasma hs-CRP , interleukin-6 ( IL-6 ) , and tumor necrosis factor-alpha ( TNF-alpha ) concentrations in 48 obese individuals with the concentrations in 10 lean normolipidemic men . The obese individuals were then r and omized to treatment with atorvastatin ( 40 mg/day ) , fish oil ( 4 g/day ) , atorvastatin plus fish oil , or matching placebo for 6 weeks . RESULTS Compared with controls , obese individuals had increased hs-CRP [ geometric mean , 2.19 mg/L ( 95 % confidence interval , 2.15 - 3.15 mg/L ) vs 0.49 mg/L ( 0.30- 0.93 mg/L ) ; P IL-6 [ 351 pg/L ( 318 - 449 pg/L ) vs 251 pg/L ( 211 - 305 pg/L ) ; P Atorvastatin treatment had a significant main effect of decreasing plasma hs-CRP ( -0.87 mg/L ; 95 % confidence interval , -0.10 to -1.60 mg/L ; P IL-6 ( -70 pg/L ; 10 to -140 pg/L ; P hs-CRP with atorvastatin were not significantly correlated to changes in plasma lipids , IL-6 , insulin resistance , or cholesterogenesis . Plasma TNF-alpha concentrations in obese individuals , however , were neither statistically different from concentrations in the lean controls nor altered with atorvastatin or fish oil treatment . CONCLUSIONS This study shows that visceral obesity is associated with increased plasma hs-CRP and IL-6 and , hence , a low- grade chronic inflammatory state and that treatment with atorvastatin or atorvastatin with fish oil , but not fish oil alone , reverses this abnormality",
"Background A recent r and omized placebo-controlled trial of the effect of atorvastatin treatment on the progression of newly diagnosed type 1 diabetes suggested a slower decline of residual beta cell function with statin treatment . Aim of this secondary analysis was to identify patient subgroups which differ in the decline of beta cell function during treatment with atorvastatin . Methodology /Principal Findings The r and omized placebo-controlled Diabetes and Atorvastatin ( DIATOR ) Trial included 89 patients with newly diagnosed type 1 diabetes and detectable islet autoantibodies ( mean age 30 years , 40 % females ) , in 12 centers in Germany . Patients received placebo or 80 mg/d atorvastatin for 18 months . As primary outcome stimulated serum C-peptide levels were determined 90 min after a st and ardized liquid mixed meal . For this secondary analysis patients were stratified by single baseline characteristics which were considered to possibly be modified by atorvastatin treatment . Subgroups defined by age , sex or by baseline metabolic parameters like body mass index ( BMI ) , total serum cholesterol or fasting C-peptide did not differ in C-peptide outcome after atorvastatin treatment . However , the subgroup defined by high ( above median ) baseline C-reactive protein ( CRP ) concentrations exhibited higher stimulated C-peptide secretion after statin treatment ( p = 0.044 ) . Individual baseline CRP levels correlated with C-peptide outcome in the statin group ( r2 = 0.3079 , p baseline CRP concentrations above median differed from the corresponding subgroup with lower CRP levels by higher median values of BMI , IL-6 , IL-1RA , sICAM-1 and E-selectin . Conclusions / Significance Atorvastatin treatment may be effective in slowing the decline of beta cell function in a patient subgroup defined by above median levels of CRP and other inflammation associated immune mediators . Trial Registration Clinical Trials.gov",
"CONTEXT Cardiovascular disease is a major cause of mortality in type 1 diabetes ( TIDM ) . TIDM is a proinflammatory state . Whereas there is consensus on lipid management in type 2 diabetes , there is a lack of data in type 1 diabetes . In addition to benefits on the lipid profile , statin therapy is antiinflammatory . OBJECTIVE There are scant data on statin therapy in T1DM . Thus , we tested the effect of simvastatin , compared with placebo , on biomarkers of inflammation and monocyte function in TIDM patients . DESIGN This was a double-blind , r and omized , placebo-controlled study of T1DM patients , r and omized to placebo or simvastatin , 20 mg/d for 3 months . SETTING The study was conducted at the University of California , Davis , Medical Center . PARTICIPANTS Participants included patients with T1DM . METHODS AND RESULTS Analytes measured at baseline and 3 months included liver function tests , creatinine , hemoglobin AIC , high-sensitivity C-reactive protein , soluble CD40 lig and , monocyte O(2)(- ) , cytokines , nuclear factor-kappaB. Simvastatin therapy result ed in significant reduction in low-density lipoprotein and non-high-density lipoprotein cholesterol , high-sensitivity C-reactive protein ( 18 % reduction , P soluble CD40 lig and ( 22 % reduction , P placebo . Simvastatin therapy significantly inhibited lipopolysaccharide-activated monocyte release of O(2)(- ) ( P IL-8 ( P TNF ( P Simvastatin therapy significantly inhibited monocyte IL-6 release , compared with baseline ( P = 0.02 ) . Simvastatin therapy also significantly reduced monocytic nuclear factor-kappaB p65 activity , compared with placebo ( P simvastatin ( 20 mg/d ) is safe in T1DM patients and has concomitant benefits on the lipid profile and biomarkers of inflammation . These novel findings could have implication s for developing policy guidelines for statin therapy in forestalling vascular complications in young T1DM",
"BACKGROUND Arterial stiffness assessed by pulse wave velocity ( PWV ) predicts all-cause and cardiovascular mortality in diabetic patients with end-stage renal disease . We studied the preventive effects of a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor , fluvastatin , on arterial PWV values in this population . METHODS Twenty-two patients with normal serum lipid levels received fluvastatin ( 20 mg/day p.o . ) or a placebo for 6 months . Their serum lipid levels , serum levels of C-reactive protein ( CRP ) , arterial PWV , and ankle brachial indexes ( ABI ) were determined before , and 3 and 6 months after taking the medication to evaluate arterial stiffness . RESULTS At the beginning of the follow-up , there were no differences in age , blood pressure , body mass index , serum haemoglobin A1c level , serum CRP level , serum lipid levels , PWV or ABI between the placebo- ( n=10 ) and the fluvastatin-treated patients ( n=12 ) . After 6 months , the PWV and the serum oxidized low-density lipoprotein cholesterol ( LDL-C ) level increased significantly ( from 1969+/-140 to 2326+/-190 cm/s and 70.4+/-13.8 to 91.8+/-15.5 U/l , respectively ) in the placebo-treated patients . However , the fluvastatin group had a significantly reduced PWV ( from 1991+/-162 to 1709+/-134 cm/s ) , oxidized LDL-C serum levels ( from 89.0+/-9.6 to 73.0+/-5.8 U/l ) and CRP serum levels ( from 0.97+/-0.32 to 0.26+/-0.16 mg/dl ) compared with those in the placebo group . CONCLUSIONS Long-term administration of fluvastatin prevents further worsening of arterial biomechanics in haemodialysis patients with type 2 diabetes mellitus , even in the presence of serum lipid levels in the normal range",
"AIMS HMG-CoA reductase inhibitors ( statins ) reduce cardiovascular mortality and morbidity in patients with stable coronary artery disease as well as acute coronary syndrome ( ACS ) . It is unclear how rapidly the beneficial effects of statins occur in patients with ACS and whether these drug properties are related to lipid lowering . METHODS AND RESULTS Patients with troponin-positive ACS ( n=35 ) were r and omized to 20 mg/day rosuvastatin therapy or to placebo treatment . Anti-inflammatory effects of rosuvastatin measured by lymphocyte intracellular cytokine production were taken before initiation of treatment and on days 1 , 3 , and 42 . Compared with placebo , rosuvastatin treatment significantly reduced plasma concentrations of pro-inflammatory cytokines TNF-alpha and IFN-gamma at 72 h. Rosuvastatin also induced a rapid and significant reduction of TNF-alpha and IFN-gamma production in stimulated T-lymphocytes at 72 h. When compared with placebo , rosuvastatin inhibited the Th-1-immune response measured at 72 h. CONCLUSION Rosuvastatin exerts rapid immunomodulatory effects on the level of T-cell activation in patients with ACS",
"BACKGROUND Heart failure has been associated with impaired endothelial function , increased inflammatory process and elevated oxidative stress status . Both statins and vitamin E separately improve endothelial function in patients with hypercholesterolemia and /or advanced atherosclerosis . AIM To evaluate the effect of atorvastatin alone or in combination with vitamin E on endothelial function and serum levels of interleukin-6 ( IL-6 ) , tumor necrosis factor alpha ( TNF-alpha ) and vascular cells adhesion molecule ( sVCAM-1 ) in patients with ischemic heart failure . METHODS Thirty-eight male patients with ischemic cardiomyopathy were r and omly divided into three groups and received either atorvastatin 10 mg/day ( n = 14 ) , a combination of atorvastatin 10 mg/day plus vitamin E 400 IU/day ( n = 12 ) , or no statin or antioxidant treatment ( n=12 , controls ) for 4 weeks . Forearm blood flow ( FBF ) was measured using venous occlusion strain-gauge plethysmography . Forearm vasodilatory response to reactive hyperemia ( RH% ) or to nitrate ( NTG% ) was defined as the percent change of FBF from rest to the maximum flow during reactive hyperemia or after nitrate administration , respectively . RESULTS RH% was significantly improved in both the atorvastatin-treated ( p atorvastatin plus vitamin E groups ( p atorvastatin-treated group ( p Serum levels of IL-6 , TNF-alpha and sVCAM-1 were decreased in the atorvastatin-treated group ( p atorvastatin treatment improves endothelial function and reduces the expression of proinflammatory cytokines and adhesion molecules in patients with ischemic heart failure , an effect partly depressed by vitamin",
"In this r and omized trial , C-reactive protein increased during the first 5 days of an acute coronary syndrome in patients treated with placebo , but this phenomenon was not observed in those r and omized to atorvastatin 80 mg/day . This suggests that short-term statin therapy inhibits inflammation in patients with non-ST-elevation acute coronary syndromes",
"SUMMARY Background : Elevated levels of C-reactive protein ( CRP ) are considered to be one of the indicators of poor prognosis in coronary artery disease ( CAD ) . The aim of this study was to evaluate anti-inflammatory effects of atorvastatin in patients with CAD by measuring serum CRP levels . Methods : After measuring the baseline levels of CRP and lipid fractions , the patients were divided into two groups . In Group A ( n = 46 ) , atorvastatin ( 20 mg/day ) was administered in addition to classic antianginal treatment ( beta-blocker , nitrate and aspirin ) . In Group B ( n = 32 ) , the usual antianginal treatment was continued . Following 4 weeks of treatment the same measurements were repeated . Results : In Group A , CRP decreased from 20.3 mg/dl ( 95 % CI , 9 - 31.8 ) to 10.8 mg/dl ( 95 % CI , 2.7 - 18.9 ) ( p CRP decreased from 17 mg/dl ( 95 % CI , 13.1 - 21 ) to 12.8 mg/dl ( 95 % CI , 9.7 - 15.9 ) ( p In patients with CAD , atorvastatin exerted an anti-inflammatory effect represented by decreasing CRP levels . This effect was independent of the change in low density lipoprotein cholesterol ( LDL-C ) or high density lipoprotein cholesterol ( HDL-C ) levels",
"OBJECTIVE We investigated whether statin improves nitric oxide ( NO ) bioactivity and reduces serological markers of oxidant stress and inflammation and whether statin-induced reduction in markers of oxidant stress and inflammation is mediated by improvement in NO bioactivity or lipoprotein changes , compared with American Heart Association Step I Diet ( Diet ) . METHODS We administered diet+placebo and diet+simvastatin 20 mg daily during 14 weeks with r and omized order to 31 and 32 patients with coronary artery disease , respectively , with a r and omized design . RESULTS Compared with diet alone , simvastatin significantly improved the percent flow-mediated dilator response to hyperemia and lowered plasma levels of tumor necrosis factor (TNF)-alpha , intercellular adhesion molecule type-1 ( ICAM-1 ) , serum levels of CRP , and fibrinogen ( P diet alone , simvastatin lowered but statistically insignificant plasma levels of nitrate and malondialdehyde ( MDA ) ( P=0.164 and P=0.150 , respectively ) . Further , we observed that patients with the highest pretreatment TNF-alpha , ICAM-1 , and CRP levels showed the greatest extent of reductions on simvastatin . There were significant inverse correlation between low-density lipoprotein ( LDL ) cholesterol or the ratio of LDL to HDL cholesterol levels and flow-mediated dilation percent ( r=-0.342 , P=0.009 and r=-0.356 , P=0.006 , respectively ) . Of interest , there were significant inverse correlations between flow-mediated dilation percent and TNF-alpha levels ( r=-0.329 , P=0.010 ) . However , no significant correlations between lipoprotein levels and levels of inflammation markers were determined . Despite the significant changes of lipoproteins , diet alone did not decrease the markers of inflammation . CONCLUSIONS Compared with diet alone , simvastatin significantly reduced markers of inflammation more . These effects were independent of lipoprotein changes",
"OBJECTIVE Statins are known to reduce CRP concentrations , but whether high doses are more effective is not known . METHODS In a prospect i ve double-blind multicenter study in 186 DM2 patients without manifest coronary artery disease and with dyslipidemia , the effect of a 30-week treatment with 10 and 80 mg atorvastatin or placebo on the reduction of hs-CRP levels was measured . RESULTS Median CRP levels increased with 6.6 % in the placebo group and were reduced by 15 and 47 % , respectively , with atorvastatin 10 and 80 mg ( P atorvastatin and from placebo ( P Variation in IL-6 and plasma lipids associated for 21 and 8 % , respectively , with variation in CRP levels ( P patients with a baseline CRP level above an arbitrary threshold of 3.0 mg/l , 56 % in the 80 mg atorvastatin group reached a level of less than 3.0 mg/l , versus 23 % r and omized to 10 mg atorvastatin ( P placebo group ( P DM2 patients high dose atorvastatin induced a strong reduction in CRP levels . The decrease in CRP was mainly independent of effects on lipid lowering and changes in IL-6 levels . The pleiotropic effect of high-dose atorvastatin on inflammation could add to its cardioprotective effect in high-risk patients",
"Background : Dialysis patients have many underlying traditional and nontraditional risk factors that may predispose them to a high prevalence of cardiovascular disease . The effects of statins ( eg , atorvastatin ) on altering nontraditional lipoprotein measures in dialysis patients have not been extensively investigated . Objective : To evaluate the efficacy of atorvastatin compared with a control group in inducing changes in lipoprotein(a ) [ Lp(a ) ] , apolipoprotein ( Apo ) A-1 , Apo-B , and fibrinogen levels , as well as the conventional lipoprotein profile , in hemodialysis patients over 36 weeks ; secondary objectives were to assess changes in C-reactive protein , albumin , and safety measures . Methods : Forty-five hemodialysis patients with low-density lipoprotein cholesterol ( LDL-C ) levels greater than 100 mg/dL were r and omized to parallel groups : atorvastatin ( n = 19 ) or no treatment ( n = 26 ) . The atorvastatin dose was titrated from 10 mg to achieve an LDL-C goal of 100 mg/dL or less and therapy was continued for 36 weeks . Biochemical and lipoprotein laboratory tests for efficacy outcomes were obtained at baseline , 12 weeks , and 36 weeks . Results : The atorvastatin group exhibited clinical ly significant reductions ( mean ± SD ) compared with controls in total cholesterol ( –21.7 ± 41.7 vs –3.2 ± 40.0 mg/dL , respectively ; p = 0.017 ) and LDL-C ( –13.1 ± 32.0 vs –1.1 ± 38.4 mg/dL. respectively ; p = 0.056 ) levels , as well as Lp(a ) ( –10.6 ± 27 vs 3.5 ± 17.8 mg/dL , respectively ; p = 0.046 ) . Statistical analyses included analysis of variance on ranked measures for multivariable modeling and paired t-test to determine changes in efficacy measures between baseline and 36 weeks within groups . Conclusions : Atorvastatin was safe and effective in reducing Lp(a ) , total cholesterol , and LDL-C levels . Given the prevalence of atherosclerosis in hemodialysis patients , therapy aim ed at reducing traditional and nontraditional risk factors may be beneficial",
"Hypercholesterolemia causes endothelial dysfunction , an early feature of atherosclerosis , leading to increased production of adhesion molecules and cytokines . The aim of this study was to investigate the effects of three months of treatment with low dose atorvastatin on serum levels of adhesion molecules , interleukin-6 ( IL-6 ) and highly sensitive C-reactive protein ( hs-CRP ) in patients with non-familial hypercholesterolemia . Fifty-five patients with non-familial hypercholesterolemia were r and omized to treatment with atorvastatin 10 mg/day or placebo for 3 months . Soluble intercellular adhesion molecules-1 ( ICAM-1 ) , vascular cell adhesion molecule-1 ( VCAM-1 ) , E-selectin , IL-6 and hs-CRP levels were measured to assess the inflammatory activity of the endothelium . There was a significant reduction in ICAM-1 at 2 weeks ( p VCAM-1 ( p IL-6 ( p hs-CRP ( p E-selectin levels ( p ICAM-1 ( p IL-6 levels ( p atorvastatin treatment leads to reduction in proinflammatory markers of endothelial function , suggesting an attenuation of endothelial activation and improvement in endothelial function , independent of lipid lowering . This may lead to a reduction in the progression of atherosclerosis",
"This study examined the effects of simvastatin on C-reactive protein ( CRP ) and other inflammatory markers in study subjects with significant elevations in triglyceride ( TG ) blood levels . CRP , vascular cellular adhesion molecule ( VCAM ) , serum amyloid A ( SAA ) , and interleukin 6 ( IL-6 ) were measured in archived plasma sample s from 2 multicenter , r and omized , double-blind , placebo-controlled studies design ed to examine the lipid-altering efficacy of simvastatin in study subjects with elevated TGs . In the first study , 130 study subjects with mixed hyperlipidemia ( low-density lipoprotein [ LDL ] cholesterol > or = 130 mg/dl ; TGs 300 to 700 mg/dl ) received placebo or simvastatin 40 or 80 mg once daily for three 6-week periods in a complete-block crossover design . In the second study , 195 study subjects with hypertriglyceridemia ( TGs 300 to 900 mg/dl ) received daily doses of placebo or simvastatin 20 , 40 , or 80 mg for 6 weeks . Significant but weak correlations were observed between baseline CRP values and baseline levels of LDL cholesterol and high-density lipoprotein ( HDL ) cholesterol , but not with TGs . CRP was also correlated with body mass index and fasting levels of glucose and insulin . Treatment with simvastatin 20 , 40 , and 80 mg led to significant reductions in CRP plasma levels versus placebo ( p CRP change was weakly correlated with changes in LDL cholesterol , TGs , and HDL cholesterol , results of regression analyses showed that only baseline CRP and treatment allocation were significant predictors of CRP response after 6 weeks of study drug administration . Simvastatin had no effect on VCAM , SAA , or IL-6 . In summary , simvastatin significantly reduced CRP in patients with mixed hyperlipidemia and hypertriglyceridemia",
"OBJECTIVES This study sought to investigate potential protective effects of atorvastatin in patients with acute coronary syndromes ( ACS ) undergoing percutaneous coronary intervention ( PCI ) . BACKGROUND R and omized studies have shown that pretreatment with atorvastatin may reduce periprocedural myocardial infa rct ion in patients with stable angina during elective PCI ; however , this therapy has not been tested in patients with ACS . METHODS A total of 171 patients with non-ST-segment elevation ACS were r and omized to pretreatment with atorvastatin ( 80 mg 12 h before PCI , with a further 40-mg preprocedure dose [ n = 86 ] ) or placebo ( n = 85 ) . All patients were given a clopidogrel 600-mg loading dose . All patients received long-term atorvastatin treatment thereafter ( 40 mg/day ) . The main end point of the trial was a 30-day incidence of major adverse cardiac events ( death , myocardial infa rct ion , or unplanned revascularization ) . RESULTS The primary end point occurred in 5 % of patients in the atorvastatin arm and in 17 % of those in the placebo arm ( p = 0.01 ) ; this difference was mostly driven by reduction of myocardial infa rct ion incidence ( 5 % vs. 15 % ; p = 0.04 ) . Postprocedural elevation of creatine kinase-MB and troponin-I was also significantly lower in the atorvastatin group ( 7 % vs. 27 % , p = 0.001 and 41 % vs. 58 % , p = 0.039 , respectively ) . At multivariable analysis , pretreatment with atorvastatin conferred an 88 % risk reduction of 30-day major adverse cardiac events ( odds ratio 0.12 , 95 % confidence interval 0.05 to 0.50 ; p = 0.004 ) . CONCLUSIONS The ARMYDA-ACS trial indicates that even short-term pretreatment with atorvastatin may improve outcomes in patients with ACS undergoing early invasive strategy . These findings may support routine use of high-dose statins before intervention in patients with ACS",
"Abstract Background and objective : Hyperglycaemia leads to increased oxidative stress result ing in endothelial dysfunction . ACE inhibitors , antioxidants and HMG-CoA reductase inhibitors ( statins ) have been shown to improve endothelial function . The aim of this study was to compare the effects of NCB-02 ( a st and ardized preparation of curcuminoids ) , atorvastatin and placebo on endothelial function and its biomarkers in patients with type 2 diabetes mellitus . Methods : A total of 72 patients with type 2 diabetes were r and omized to receive NCB-02 ( two capsules containing curcumin 150 mg twice daily ) , atorvastatin 10 mg once daily or placebo for 8 weeks . Endothelial function assessment was performed at baseline and post-treatment using digital volume plethysmography ( salbutamol [ albuterol ] challenge test ) to measure change in reflective index , an indicator of arterial vascular tone . Blood sample s were similarly collected at baseline and post-treatment for estimations of malondialdehyde , endothelin-1 ( ET-1 ) , interleukin-6 ( IL-6 ) and tumour necrosis factor-α ( TNFα ) . Pre- and posttreatment safety assessment s were also conducted . ANOVA and paired t-test evaluations were used for comparison . Results : A total of 67 patients completed the study . At baseline , there was no significant difference in the various parameters tested . In all three groups , the change in reflective index at baseline was improvement in endothelial function after treatment with atorvastatin ( mean ± SD : −3.63 ± 3.17 % vs −8.95 ± 6.80 % , respectively ) and NCB-02 ( −2.69 ± 3.02 % vs −8.19 ± 5.73 % , respectively ) . Similarly , patients receiving atorvastatin or NCB-02 showed significant reductions in the levels of malondialdehyde , ET-1 , IL-6 and TNFα . No significant improvements were obtained in patients administered placebo . Conclusion : NCB-02 had a favourable effect , comparable to that of atorvastatin , on endothelial dysfunction in association with reductions in inflammatory cytokines and markers of oxidative stress . Further studies are needed to evaluate the potential long-term effects of NCB-02 and its combination with other herbal antioxidants ",
"To determine the effects of statins on vascular function , inflammation , and and rogen levels in women with polycystic ovary syndrome ( PCOS ) , we r and omized 20 women with PCOS who had low-density lipoprotein cholesterol levels > 100 mg/dL to atorvastatin ( 40 mg/day ) or placebo for 6 weeks and found that atorvastatin reduced and rogen levels , biomarkers of inflammation , and blood pressure ; increased insulin levels and brachial artery conductance during reactive hyperemia ; and failed to improve brachial artery flow-mediated dilation . We conclude that until additional studies demonstrate a clear risk-to-benefit ratio favoring statin therapy in PCOS , statins should only be used in women with PCOS who meet current indications for statin treatment",
"Endothelial dysfunction is frequently found in diabetic subjects . This study was performed to investigate whether atorvastatin therapy was able to reverse endothelial dysfunction in type 2 diabetes and , if so , whether the effect was due to its antiinflammatory action . Eighty patients ( baseline low density lipoprotein , 4.37 + /- 0.71 mmol/liter ) were r and omized to atorvastatin ( 10 mg daily for 3 months , followed by 20 mg daily for 3 months ) or placebo in a double blind study . Endothelial function was assessed by high resolution vascular ultrasound , and high sensitivity C-reactive protein ( CRP ) was assessed by immunoturbidimetric assay . Diabetic patients had higher CRP ( P endothelium-dependent and independent vasodilation were impaired ( P Atorvastatin ( 10 and 20 mg ) lowered plasma cholesterol by 32.9 % and 38.0 % , triglyceride by 15.4 % and 23.1 % , and low density lipoprotein by 43.4 % and 50.1 % , respectively . At 6 months , plasma CRP decreased in the atorvastatin group compared with baseline ( P Endothelium-dependent vasodilation improved in the atorvastatin group compared with the placebo group ( P percent change in endothelium-dependent vasodilation at 6 months correlated with the percent change in CRP ( r = -0.44 ; P plasma lipids . In conclusion , treatment with atorvastatin in type 2 diabetes led to a significant improvement in endothelium-dependent vasodilation , which might be partly related to its anti-inflammatory effect",
"BACKGROUND Inflammation promotes acute coronary syndromes ( ACS ) and ensuing clinical complications . It is well known that statins decrease the risk of coronary events and may benefit the stabilization of atherosclerotic plaque with their anti-inflammatory effects . We investigated the effects of different doses of fluvastatin on serum concentrations of high-sensitive C-reaction protein ( hs-CRP ) and tumor necrosis factor-alpha ( TNF-alpha ) in the early phase of ACS . METHODS We prospect ively r and omized 60 patients with ACS to 3 groups : ( 1 ) group A ( n=20 ) : were given routine therapy ; ( 2 ) group B ( n=20 ) : were administrated routine therapy with 40 mg/d oral fluvastatin ; ( 3 ) group C ( n=20 ) : received routine therapy with 80 mg/d oral fluvastatin . Twenty patients with stable coronary heart disease served as controls . The following-up period was 7 days . By immunoturbidimetric assay and ELISA methods the serum concentrations of hs-CRP and TNF-alpha were measured before and after therapy . RESULTS ( 1 ) The serum concentrations of hs-CRP and TNF-alpha in patients with ACS was significantly higher than those in the control group ( P serum concentrations of hs-CRP and TNF-alpha were significantly lower in group B and group C ( all P serum concentrations of hs-CRP and TNF-alpha did not correlate to the concentrations of TC , TG , LDL-C , or HDL-C. CONCLUSION Early fluvastatin intervention decreases dose-dependently the serum concentrations of hs-CRP and TNF-alpha of patients with ACS . The high-dose fluvastatin invention may play a stronger anti-inflammatory effect in ACS patients . The anti-inflammatory effect of fluvastatin may be beyond the lipid lowering",
"BACKGROUND Mixed hyperlipidemia is characterized by elevated low-density lipoprotein cholesterol ( LDL-C ) , triglyceride ( TG ) , and TG-rich lipoprotein levels . METHODS In a multicenter , r and omized , double-blind , placebo-controlled , parallel arm trial , eligible patients were 18 to 79 years of age , with mixed hyperlipidemia ( LDL-C 130 - 220 mg/dL , TG 150 - 500 mg/dL ) . Patients with type 2 diabetes were limited to those with LDL-C of 100 to 180 mg/dL. Patients ( N = 611 ) were r and omized in a 3:3:3:1 ratio to one of 4 treatment arms for 12 weeks : ezetimibe/simvastatin 10/20 mg ( EZE/SIMVA ) + fenofibrate 160 mg ( FENO ) , EZE/SIMVA 10/20 mg , FENO 160 mg , or placebo . The primary objective was to evaluate the LDL-C-lowering efficacy of EZE/SIMVA + FENO versus FENO monotherapy . RESULTS Low-density lipoprotein cholesterol level was significantly ( P EZE/SIMVA + FENO ( -45.8 % ) compared with FENO ( -15.7 % ) or placebo ( -3.5 % ) , but not when compared with EZE/SIMVA ( -47.1 % ) . High-density lipoprotein cholesterol and apolipoprotein A-I levels were significantly increased with EZE/SIMVA + FENO ( 18.7 % and 11.1 % , respectively ) treatment compared with EZE/SIMVA ( 9.3 % and 6.6 % ) or placebo ( 1.1 % and 1.6 % ) , but not when compared with FENO ( 18.2 % and 10.8 % ) . Triglyceride , non-high-density lipoprotein cholesterol , and apolipoprotein B levels were significantly reduced with EZE/SIMVA + FENO ( -50.0 % , -50.5 % , and -44.7 % , respectively ) versus all other treatments . Treatment with EZE/SIMVA + FENO was generally well tolerated with a safety profile similar to the EZE/SIMVA and FENO therapies . CONCLUSIONS Coadministration of EZE/SIMVA + FENO effectively improved the overall atherogenic lipid profile of patients with mixed hyperlipidemia . Clinical trial registry number : NCT 00093899 ( http://www . Clinical Trials.gov )",
"The role of inflammation in acute coronary syndrome ( ACS ) and the mechanism by which statin treats ACS is explored . Serum high-sensitivity C-reactive protein ( hs-CRP ) and interleukin-6 ( IL-6 ) levels were measured in 50 patients with ACS [ including 30 cases with unstable angina ( UA ) and 20 patients with acute myocardial infa rct ion ( AMI ) ] , 34 patients with stable angina ( SA ) , and 30 controls . Patients in the ACS group were r and omly assigned to a simvastatin group ( including a simvastatin AMI subgroup , n = 11 and a simvastatin UA subgroup , n = 14 ) and a routine group ( including a routine AMI subgroup , n = 9 and a routine UA subgroup , n = 16 ) . The simvastatin group was given simvastatin 20 mg/day and the routine group a placebo . After a 3-week follow-up , serum hs-CRP , IL-6 levels , and serum lipid concentrations were measured again . Both serum IL-6 and hs-CRP levels were significantly higher in the ACS group ( including the UA and AMI subgroups ) than in the SA and control groups ( P simvastatin , the serum IL-6 , hs-CRP , total cholesterol , and low-density lipoprotein cholesterol levels were decreased significantly in the simvastatin group ( P serum IL-6 or hs-CRP and serum lipids levels . The hs-CRP level showed a significant correlation with IL-6 by Spearman ’s rank correlation analysis ( P Simvastatin possesses an anti-inflammatory effect , independent of its lipid-lowering action , which may play an important role in the early treatment of ACS",
"BACKGROUND The increase in serum C-reactive protein ( CRP ) levels is an independent determinant of cardiovascular events in long-term hemodialysis ( HD ) patients . Recently , statins have shown anti-inflammatory properties in addition to their lipid-lowering effect . METHODS We design ed a 6-month , prospect i ve , r and omized , controlled study to assess the safety and efficacy of atorvastatin in reducing serum CRP levels in long-term HD patients . Patients on HD therapy for at least 6 months , with autologous vascular access , were included . Patients presenting with illnesses and /or use of drugs that may affect CRP levels were excluded . After r and omization , group A included 16 patients treated with atorvastatin ( 10 mg/d orally ) , and group B included 17 patients treated with placebo . Body mass index , Kt/V , normalized protein catabolic rate , mean blood pressure , and levels of hemoglobin , serum CRP , albumin , creatinine , lipids , and enzymes were recorded at baseline and after 6 months . RESULTS Qualitative/quantitative parameters were homogeneous between the groups at baseline . In group A , median serum CRP levels decreased from 9 mg/L ( range , 5 to 22 mg/L ) at baseline to 5 mg/L ( range , 3 to 16 mg/L ) after 6 months ( P = 0.004 ) . In group B , values were 8 mg/L ( range , 4 to 14 mg/L ) at baseline and 7 mg/L ( range , 3 to 17 mg/L ) after 6 months ( P = 0.98 ) . Serum CRP levels were lower in group A than group B at month-4 ( 5 mg/L ; range , 3 to 11 mg/L versus 7 mg/L ; range , 3 to 10 mg/L , respectively ; P = 0.054 ) and month-6 evaluations ( 5 mg/L ; range , 3 to 16 mg/L versus 7 mg/L ; range , 3 to 17 mg/L , respectively ; P = 0.060 ) . After 6 months , only in group A was there a significant decrease in serum cholesterol levels ( P = 0.041 ) and a significant increase in serum albumin levels ( P = 0.004 ) . Enzyme levels were stable during the study in both groups . CONCLUSION Administration of atorvastatin is safe in patients on long-term HD therapy and , in addition to its beneficial effects on lipid levels , induces a significant decrease in serum CRP levels , with a consequential increase in serum albumin levels ",
"STUDY OBJECTIVES To determine the effects of atorvastatin on low-density lipoprotein cholesterol ( LDL ) particle size and C-reactive protein ( CRP ) concentrations in patients undergoing long-term hemodialysis . Another objective was to compare the effects of atorvastatin on lipoprotein profiles as determined by direct versus indirect assessment of lipoprotein composition . DESIGN R and omized , parallel-group sub study . SETTING Two university-affiliated outpatient hemodialysis centers . PATIENTS Nineteen patients with LDL levels above 100 mg/dl and with at least two cardiovascular risk factors . INTERVENTION Patients were r and omized in a 1:1 ratio to atorvastatin 10 mg/day or no treatment ( control ) for 20 weeks . MEASUREMENTS AND MAIN RESULTS We compared the differences between LDL particle size and CRP levels at baseline and 20 weeks in the atorvastatin versus control groups . Baseline demographic characteristics were similar between the two groups . Atorvastatin therapy was associated with no change in mean LDL particle size ( p=0.23 ) and with a 90 % decrease in mean CRP level ( p=0.52 ) . When evaluated by st and ard chemical analysis , atorvastatin therapy reduced total cholesterol levels by 29 % ( p=0.025 ) and result ed in nonsignificant reductions in LDL , high-density lipoprotein cholesterol , and triglyceride levels . Treatment with atorvastatin was not associated with significant changes in lipoprotein profile as determined by nuclear magnetic resonance ( NMR ) spectroscopy . CONCLUSION Treatment with atorvastatin did not affect LDL particle size but was associated with a sizable , yet nonsignificant , reduction in CRP concentrations . The drug had variable effects on lipoprotein concentrations as determined by chemical and NMR analytical methods . A larger study is necessary to provide definitive information on the effects of atorvastatin on LDL phenotype and CRP in patients with kidney disease",
"BACKGROUND AND AIMS Inflammation is highly prevalent in patients on dialysis . Statins have anti-inflammatory actions but their use has been scarcely studied in continuous ambulatory peritoneal dialysis ( CAPD ) . We undertook this study to compare the effect of pravastatin vs. placebo on the serum concentrations of C-reactive protein ( CRP ) in patients on CAPD . METHODS In a double-blind , controlled and crossover clinical trial , 76 CAPD patients were r and omized to either pravastatin or placebo for 2 months . After this first period of treatment , patients had a 1-month wash-out period and , finally , they were crossed-over to receive the other drug ( or placebo ) for 2 more months . Measurement of clinical and biochemical variables and CRP was performed at the beginning and at the end of each treatment period . RESULTS Median CRP was only significantly decreased in the pravastatin group in both periods of treatment : first period ( baseline vs. final , mg/L ) : pravastatin 7.4 ( 2 - 21 ) vs. 2.6 ( 1 - 6 ) , p placebo 3.9 ( 2 - 10 ) vs. 6.8 ( 3 - 12 ) , pNS ; second period : pravastatin 4.3 ( 2 - 15 ) vs. 1.9 ( 1 - 7 ) , p placebo 4.9 ( 2 - 17 ) vs. 6.8 ( 2 - 19 ) , p total and LDL-cholesterol significantly decreased in the pravastatin group . CONCLUSIONS Pravastatin significantly reduced serum levels of CRP and total and LDL-cholesterol compared to placebo . This treatment may be of great help to decrease the inflammatory status and probably the cardiovascular disease of CAPD patients",
"Stabilization of carotid artery plaques by pharmacologic intervention is a promising strategy for the prevention of ischemic stroke . In this study , we examined the effect of 12 months of statin therapy on carotid plaque echogenicity . This study included 81 hypercholesterolemic patients with carotid atherosclerotic plaques . Echogenicity of the largest plaque in each patient was evaluated by ultrasound with integrated backscatter analysis . All patients underwent dietary modification . Forty patients were treated with simvastatin ( 10 mg/day , n = 24 ) or atorvastatin ( 5 mg/day , n = 16 ) according to the choice by each attending physician . Carotid plaques were monitored by measuring plaque thickness and echogenicity during a 12-month follow-up period . Levels of serum high-sensitivity CRP ( hs-CRP ) , interleukin (IL)-6 and IL-18 were determined in all patients . Total cholesterol , triglyceride , hs-CRP and IL-18 were significantly decreased after 12 months of statin therapy . The change in IL-6 level was not significant . Significant increases in echogenicity of carotid plaques and decreases in plaque thickness were noted after statin therapy . In the 41 patients without statin therapy , carotid plaque echogenicity , plaque thickness and serum levels of inflammatory markers were not significantly altered . Our results suggest that statin therapy in hypercholesterolemic patients for 12 months increases carotid plaque echogenicity and decreases plaque thickness , in addition to lowering serum levels of lipids and inflammatory markers",
"BACKGROUND AND AIMS Inflammation and postpr and ial lipemia are associated with increased cardiovascular disease . We investigated whether ezetimibe and simvastatin combination , a lipid lowering combination of simvastatin and ezetimibe , exerts an anti-inflammatory effect in the fasting state and after dairy cream intake . METHODS Twenty obese patients were r and omized to either ezetimibe and simvastatin combination or placebo treatment for 6 weeks . All patients were asked to ingest 33 ml of dairy cream ( 300 Calories ) at the beginning and at the end of intervention . Fasting and post-cream blood sample s were obtained . RESULTS At 0 week , ingestion of cream induced significant increases in MNC expression of IL-1β ( 105 ± 18 % ) , TNFα ( 97 ± 12 % ) , CD68 ( 48 ± 8 % ) , CD16 ( 141 ± 39 % ) , MMP-9 ( 122 ± 31 % ) , PECAM ( 66 ± 10 % ) , TLR-4 ( 84 ± 11 % ) and TLR-2 ( 67 ± 9 % ) and in endotoxin ( LPS ) concentrations ( 49 ± 7 % ) ( p 0.05 ) . Ezetimibe and simvastatin combination treatment lowered fasting total cholesterol , LDLc and Lp(a ) concentrations and Apo B/A1 ratio and suppressed the MNC expression of IL-1β and CD68 ( by 21 ± 7 and 24 ± 10 , p the concentrations of LPS , CRP , FFA and IL-18 by 24 ± 7 % , 32 ± 11 % , 19 ± 8 % 15 ± 4 % , respectively , ( p increases in the expression of IL-1β , CD68 , CD16 , MMP-9 , TNFα and PECAM were reduced in the ezetimibe and simvastatin combination group by 74 ± 15 % , 68 ± 13 % , 57 ± 13 % , 64 ± 16 % , 67 ± 14 % and 45 ± 9 % , respectively , while those of LPS and MMP-9 concentrations were reduced by 53 ± 9 % and 38 ± 8 % , respectively , compared to the increases at week 0 ( p suppression of TLR-2 and TLR-4 expression by 21 ± 8 % and 18 ± 7 % , respectively , compared to 0-h baseline , after cream intake following ezetimibe and simvastatin combination treatment . CONCLUSIONS Ezetimibe and simvastatin combination exerts a profound anti-inflammatory effect both in the fasting state and acutely after the ingestion of saturated fat",
"Objectives : A high loading dose of atorvastatin has been confirmed to reduce postprocedural events in patients undergoing percutaneous coronary intervention ( PCI ) . In this study , we sought to investigate the protective effects of rosuvastatin in patients with acute coronary syndromes ( ACS ) undergoing PCI and to determine the effect of rosuvastatin pretreatment on the postprocedural levels of high-sensitivity C-reactive protein ( hs-CRP ) , interleukin 6 ( IL-6 ) , and monocyte chemotactic protein 1 ( MCP-1 ) . Methods : A total of 125 patients with non-ST-segment elevation ACS were r and omized to pretreatment with rosuvastatin ( 20 mg 2 - 4 hours before PCI [ n = 62 ] ) or placebo ( n = 63 ) . All the patients received subsequent long-term rosuvastatin treatment ( 10 mg/d ) . The main end point of the trial was the 30-day incidence of major adverse cardiac events ( death , myocardial infa rct ion , or unplanned revascularization ) . Plasma levels of hs-CRP , IL-6 , and MCP-1 were detected before PCI and 6 hours , 24 hours , and 3 days after PCI . Results : The primary end point occurred in 8.1 % of the patients in the rosuvastatin arm and 22.2 % in the placebo arm ( P myocardial infa rct ion ( 8.1 % vs 22.2 % ; P postprocedural elevation in creatine kinase-MB and troponin I was also significantly lower in the rosuvastatin group at 6 hours , 24 hours , and 3 days . Plasma levels of hs-CRP , IL-6 , and MCP-1 increased significantly after PCI in both the rosuvastatin and control groups ; however , the postprocedural elevations in hs-CRP and IL-6 levels were significantly lower in the rosuvastatin group than the control group . Conclusions : A single , high dose ( 20 mg ) of rosuvastatin prior to PCI reduces postprocedural myocardial injury in patients with ACS , with a concomitant attenuation of the postprocedural increase in hs-CRP and IL-6 levels",
"OBJECTIVE This study aim ed to evaluate the effects of statin therapy on serum levels of antibodies to several specific heat shock proteins ( HSPs ) in dyslipidemic patients . DESIGN AND METHODS Participants ( n=102 ) were treated with simvastatin ( 40mg/day ) , or placebo in a r and omized , double-blind , placebo-controlled , cross-over trial . Anti-HSP60 , 65 , 70 , and hs-CRP levels were measured before and after each treatment period . Seventy-seven subjects completed the study . RESULTS Treatment with simvastatin was associated with significant reductions in serum anti-HSP60 , 65 , and 70 titers in the dyslipidemic patients ( 10 % , 14 % , and 15 % decrease , respectively ) ( p serum CRP with statin treatment , and although median CRP levels were 9 % lower on simvastatin treatment , this did not achieve statistical significance . CONCLUSION While it is unclear whether HSP antibodies are directly involved in atherogenesis , our findings suggest that simvastatin inhibits autoimmune responses that may contribute to the development of cardiovascular disease",
"OBJECTIVE To compare the efficacy and safety of 10 mg of ezetimibe coadministered with simvastatin with the safety and efficacy of simvastatin monotherapy for patients with hypercholesterolemia . PATIENTS AND METHODS This multicenter double-blind , placebo-controlled , factorial study enrolled 887 patients with hypercholesterolemia ( low-density lipoprotein cholesterol [ LDL-C ] , 145 - 250 mg/dL ; triglycerides , Patients were r and omized to 1 of 10 treatments -- placebo , ezetimibe at 10 mg/d , simvastatin at 10 , 20 , 40 , or 80 mg/d , or simvastatin at 10 , 20 , 40 , or 80 mg/d plus ezetimibe at 10 mg/d for 12 weeks . The study began March 13 , 2001 , and ended January 8 , 2002 . The primary efficacy end point was the mean percent change in LDL-C levels from baseline to study end point ( last available postbaseline LDL-C measurement ) for the pooled ezetimibe/simvastatin group vs the pooled simvastatin monotherapy group . RESULTS Coadministration of ezetimibe/simvastatin was significantly ( P simvastatin alone in reducing LDL-C levels for the pooled ezetimibe/simvastatin vs pooled simvastatin analysis and at each specific dose comparison . The decrease in LDL-C levels with coadministration of ezetimibe and the lowest dose of simvastatin , 10 mg , was similar to the decrease with the maximum dose of simvastatin , 80 mg . A significantly ( P ezetimibe/simvastatin group achieved target LDL-C levels compared with those in the monotherapy group . Treatment with ezetimibe/simvastatin also led to greater reductions in total cholesterol , triglyceride , non-high-density lipoprotein cholesterol , and apolipoprotein B levels compared with simvastatin alone ; both treatments increased high-density lipoprotein cholesterol levels similarly . The safety and tolerability profiles for the ezetimibe/simvastatin and monotherapy groups were similar . CONCLUSION Through dual inhibition of cholesterol absorption and synthesis , coadministration of ezetimibe/simvastatin offers a highly efficacious and well-tolerated lipid-lowering strategy for treating patients with primary hypercholesterolemia",
"OBJECTIVES This study examined the effect of statin therapy on vascular markers of inflammation and echocardiographic findings in patients with nonischemic forms of cardiomyopathy . BACKGROUND Despite advances in therapy , morbidity and mortality from heart failure ( HF ) remain high . We wished to determine whether treatment with atorvastatin affects left ventricular ( LV ) systolic function and markers of inflammation in patients with nonischemic HF . METHODS A total of 108 patients with nonischemic HF and a left ventricular ejection fraction ( LVEF ) atorvastatin 20 mg/day or placebo in a double-blinded fashion for a 12-month period . The LVEF and LV end-diastolic diameter ( LVEDD ) and left ventricular end-systolic diameter ( LVESD ) were determined by echocardiography . Serum markers of inflammation and oxidation were also measured . RESULTS The LVEF increased from 0.33 + /- 0.05 to 0.37 + /- 0.04 ( p = 0.01 ) in the atorvastatin group over the 12-month follow-up period , whereas those patients in the placebo group experienced a decline in ejection fraction during the same time period . In addition , LVEDD was reduced from 57.1 + /- 5.9 mm to 53.4 + /- 5.1 mm ( p = 0.007 ) and LVESD was reduced from 42.4 + /- 3.8 mm to 39.1 + /- 3.8 mm ( p = 0.02 ) in the cohort of patients treated with atorvastatin ; these dimensions increased in the placebo group . There was an increase in erythrocyte superoxide dismutase ( E-SOD ) activity , and there were significant reductions in serum levels of high sensitivity C-reactive protein , interleukin-6 ( IL-6 ) , and tumor necrosis factor-alpha receptor II ( TNF-alpha RII ) in the atorvastatin group . CONCLUSIONS The use of atorvastatin in patients with nonischemic HF improves LVEF and attenuates adverse LV remodeling . The effects on soluble levels of several inflammatory markers with atorvastatin suggest , in part , mechanisms by which statins might exert their beneficial effects in nonischemic HF",
"A r and omized , crossover study compared the effects of atorvastatin , gemfibrozil and their combination on inflammatory markers in type 2 diabetes . C-reactive protein ( CRP ) , lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) , secretory phospholipase A2 ( sPLA2 ) , interleukin 8 ( IL8 ) , monocyte chemotactic protein 1 ( MCP1 ) and tumor necrosis factor α ( TNFα ) were measured . Both lipid-lowering drugs had positive , complementary and additive effects on inflammatory markers , which were closely related to baseline inflammatory status",
"Statins exert a number of anti-inflammatory and immunomodulatory effects in vitro . However , the immunomodulatory effects in vivo are less clarified . In the present study , we investigated whether simvastatin treatment changed the levels of autoantibodies against specific oxidized LDL ( oxLDL ) antigens as well as their association with leukocyte activation markers . Eighty volunteers with mild-to-moderate hypercholesterolemia were r and omized to either simvastatin 40 mg or placebo for 6 weeks . Autoantibodies against apo B peptide antigens , C-reactive protein ( CRP ) and interleukin (IL)-6 in plasma were determined by ELISA . Subsets of circulating B and T cells were studied by flow cytometry . Simvastatin significantly reduced CRP by 26 % , whereas IL-6 remained unchanged . Levels of IgG against the apo B peptide P-240 ( amino acids 3586–3605 ) increased by 16 % ( p = 0.03 ) in the simvastatin group whereas autoantibody levels to other apo B peptides did not change . At baseline and after 6 weeks , the P-240 IgG levels were significantly correlated with the number of CD57+CD28 − CD8+T cells but not to other lymphocyte subsets or inflammatory markers . The P-240 IgG levels after 6 weeks simvastatin therapy was strongly correlated to the relative increase in CD57+CD28 − CD8+T cells ( p = 0.003 ) . Simvastatin treatment induced an increase in autoantibodies against an oxLDL antigen . The effect was related to an expansion of a CD8+T cell subset and may involve an immunostimulation by simvastatin ",
"Objective . Increased serum pro-inflammatory cytokine levels are associated with an increased mortality rate in end-stage renal disease ( ESRD ) patients . Statins decrease cardiovascular mortality and serum C-reactive protein ( CRP ) levels in hemodialysis patients . As the anti-inflammatory effect of statins has not previously been studied in peritoneal dialysis ( PD ) patients with a non-inflammatory status , we wanted to investigate the anti-inflammatory effect of simvastatin in these patients . Material and methods . Forty-eight PD patients were r and omly allocated to either simvastatin treatment ( n=25 ) or placebo ( n=23 ) . Patients in the active-treatment group received simvastatin 20mg/day for 1 month . At baseline and after 1 month of treatment , blood sample s were drawn and high-sensitivity CRP , interleukin-6 , tumor necrosis factor (TNF)-α and plasma lipid profiles were determined . These parameters were compared between the groups at baseline and at the end of the study period . Results . Twenty-five subjects in the treatment group and 20 in the placebo group completed the study . Three patients in the placebo group were excluded from the study due to the occurrence of bacterial peritonitis during the study period . Clinical characteristics and baseline parameters were similar in both groups . Serum total and low-density lipoprotein cholesterol levels , and triglyceride and serum TNF-α levels decreased significantly compared to baseline in the treatment group ; there were no corresponding differences in the placebo group . Conclusions . Simvastatin decreased the serum TNF-α level in PD patients with a non-inflammatory status . A decrease in the TNF-α level could be one of the possible mechanisms of the anti-atherogeneic effect of simvastatin . We suggest that different treatment strategies aim ed at decreasing serum cytokine levels could be evaluated to decrease cardiovascular morbidity and mortality in the dialysis population",
"We have investigated the effect of atorvastatin on the endothelial function of patients with diabetes and subjects at risk for type 2 diabetes in a 12-wk , prospect i ve , r and omized , placebo-controlled , double-blind clinical trial . The flow- mediated dilation ( FMD ; endothelium dependent ) and nitroglycerin-induced dilation ( endothelium independent ) in the brachial artery and the vascular reactivity at the forearm skin were measured . FMD improved in the atorvastatin-treated , at-risk subjects [ median ( 25 - 75 percentile ) , 7.2 % ( 2.9 - 9.6 % ) at exit visit vs. 6.6 % ( 2.9 - 9.5 % ) at baseline ; P FMD was found in atorvastatin-treated diabetic patients [ median ( 25 - 75 percentile ) , 5.6 ( 3.9 - 7.9 ) at exit visit vs. 4.2 ( 3.2 - 7.2 ) at baseline ; P = 0.07 ] . No changes were observed in nitroglycerin-induced dilation and the microcirculation reactivity measurements in either group . In the at-risk group , there was a decrease in the C-reactive protein [ median ( 25 - 75 percentile ) , 0.12 mg/dl ( 0.07 - 0.27 mg/dl ) at exit visit vs. 0.24 mg/dl ( 0.07 - 0.35 mg/dl ) at baseline ; P TNF alpha [ median ( 25 - 75 percentile ) , 2.6 pg/ml ( 1.8 - 4.1 pg/ml ) at exit visit vs. 4.4 pg/ml ( 3.6 - 6.0 pg/ml ) at baseline ; P atorvastatin-treated patients , whereas in the diabetes group , a decrease in endothelin-1 ( mean + /- SD , 0.97 + /- 0.29 pg/ml at exit visit vs. 1.19 + /- 0.42 pg/ml at baseline ; P plasminogen activator inhibitor-1 [ median ( 25 - 75 percentile ) , 18 ng/ml ( 9 - 24 ng/ml ) at exit visit vs. 27 ng/ml ( 7 - 41 ng/ml ) at baseline ; P atorvastatin improves endothelial function and decreases levels of markers of endothelial activation and inflammation ",
"A 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor is recommended in hemodialysis ( HD ) patients with hypercholesterolemia to improve their lipid profiles . We evaluated effects of simvastatin on markers for inflammation , oxidative stress , and coagulation in HD patients . Sixty-two maintenance HD patients with serum cholesterol levels of 200 mg/dL or greater were r and omly assigned to the treatment group ( n = 31 ; 8 men , 23 women ; age , 63 + /- 11 years ) and administered simvastatin , 20 mg/d , for 8 weeks or to the control group ( n = 31 ; 10 men , 21 women ; age , 60 + /- 12 years ) . We measured cholesterol , albumin , high-sensitivity C-reactive protein ( hs-CRP ) , malondialdehyde ( MDA ; an index of lipid peroxidation ) , and D-dimer ( a marker of intravascular coagulation ) in blood at baseline and again at 8 weeks . Fifty-eight of 62 patients completed the study . In the control group , total cholesterol , serum albumin , hs-CRP , MDA , and D-dimer levels did not change . In the treatment group , simvastatin administration for 8 weeks significantly reduced total cholesterol levels from 232 + /- 25 to 165 + /- 39 mg/dL ( P hs-CRP levels from a median of 0.23 mg/dL ( range , 0.05 to 1.63 mg/dL ) to 0.12 mg/dL ( range , serum albumin levels from 3.4 + /- 0.3 to 3.6 + /- 0.4 g/dL ( P simvastatin did not affect MDA and D-dimer levels . These results suggest that in addition to the lipid-lowering effect , simvastatin had an antiinflammatory effect in HD patients . Considering that atherosclerosis is inflammation of the vascular wall , simvastatin may have a beneficial effect on cardiovascular disease , in part because it alleviates inflammation",
"BACKGROUND Inflammation may contribute to the high cardiovascular risk in diabetes mellitus ( DM ) and chronic kidney disease ( CKD ) . Monocyte chemoattractant protein-1 ( MCP-1 ) facilitates the recruitment of monocytes into atherosclerotic lesions and is involved in diabetic nephropathy . Interferon gamma ( IFNγ ) is important in atherosclerosis and increases the synthesis of chemokines including MCP-1 . Lipid-lowering treatment ( LLT ) with statins may have anti-inflammatory effects , and ezetimibe cotreatment provides additional cholesterol lowering . METHODS After a placebo run-in period , the effects of simvastatin alone ( S ) or simvastatin + ezetimibe ( S+E ) were compared in a r and omized , double-blind , cross-over study on inflammatory parameters . Eighteen DM patients with estimated glomerular filtration rate ( eGFR ) 15 - 59 mL/min × 1·73 m(2 ) ( CKD stages 3 - 4 ) ( DM-CKD ) and 21 DM patients with eGFR > 75 mL/min ( DM only ) were included . RESULTS At baseline , monocyte chemoattractant protein 1 ( MCP-1 ) ( P = 0·03 ) , IFNγ ( P = 0·02 ) , tumour necrosis factor-α ( TNFα ) ( P 0·01 ) and soluble vascular adhesion molecule ( sVCAM ) ( P = 0·001 ) levels were elevated in DM-CKD compared with DM-only patients . LLT with S and S+E reduced MCP-1 levels ( P and IFNγ levels ( P DM patients with CKD stages 3 - 4 had increased inflammatory activity compared with DM patients with normal GFR . Lipid-lowering treatment decreased the levels of MCP-1 and IFNγ in DM patients with concomitant CKD , which may be beneficial with regard to the progression of both atherosclerosis and diabetic nephropathy",
"BACKGROUND Contrast media cause oxidative stress , which has been suggested as one possible mechanism responsible for contrast-induced nephropathy . Statins appear to have pleiotropic effects , including antioxidant properties . We investigated to determine whether simvastatin pretreatment reduces the risk of contrast-induced nephropathy in a high-risk population of patients with renal insufficiency undergoing coronary angiography . METHODS We conducted a prospect i ve , r and omized , double-blind , placebo-controlled , 2-center trial , involving 247 consecutive patients with chronic renal insufficiency ( calculated creatinine clearance or = 1.1 mg/dL ) undergoing coronary angiography . Patients were r and omized to simvastatin ( n = 124 ; 160 mg total , 40 mg orally every 12 hours starting the evening before and ending the morning after the procedure ) or placebo ( n = 123 ) . All patients received pre - and postprocedure hydration . The iso-osmolar contrast agent iodixanol was used for coronary angiography in all patients . RESULTS There was no difference between simvastatin and placebo in mean peak increase in serum creatinine measured within 48 hours after coronary angiography , the primary study end point ( 0.002 + /- 0.164 vs 0.017 + /- 0.230 mg/mL respectively , P = .559 ) . The incidence of contrast-induced nephropathy , a secondary end point defined as increase of either > or = 25 % or > or = 0.5 mg/dL in serum creatinine , was 2.5 % in simvastatin-treated patients ( 3/118 ) and 3.4 % in placebo-treated patients ( 4/118 ) , a nonsignificant difference ( P = 1.00 ) . There were also no differences between the 2 groups in length of hospital stay or 1- and 6-month clinical outcomes . CONCLUSIONS Simvastatin pretreatment for short-term at high dose do not prevent renal function deterioration after administration of contrast medium in patients with baseline renal insufficiency undergoing coronary angiography",
"Objectives The aim of this work was to investigate the efficacy and safety of loading-dose rosuvastatin therapy in elderly patients with non-ST-segment elevation acute coronary syndromes ( NSTEACS ) undergoing elective percutaneous coronary intervention ( PCI ) . Methods A total of 126 patients ( ≥70 years old ) with NSTEACS were r and omly divided into two groups : ( 1 ) loading-dose rosuvastatin-treated group , treated with rosuvastatin 20 mg 12 h prior to PCI , with a second dose administered just before PCI ( n = 62 ) , and ( 2 ) control-treated group , treated with the st and ard method according to ACC/AHA guidelines in UAP/NSTEMI 2007 ( n = 64 ) . All patients were required to take rosuvastatin 10 mg once a day starting 24 h after the surgery irrespective of the initial r and omization assignment . The serum soluble lectin-like oxidized low-density lipoprotein receptor-1 ( sLox-1 ) , high-sensitivity C-reactive protein ( hs-CRP ) , creatinine kinase (CK)-MB , cardiac troponin I ( cTnI ) , and brain natriuretic peptide ( BNP ) levels were measured prior to PCI and at 24 h and 30 days after PCI in both groups . The left ventricular ejection fraction ( LVEF ) levels were recorded prior to PCI and 30 days after PCI in both groups . Results Compared to pre-PCI , the serum sLox-1 , hs-CRP , CK-MB , and cTnI levels were increased at 24 h after PCI ( all p the increased sLox-1 , hs-CRP , CK-MB , and cTnI values were significantly lower in the loading-dose rosuvastatin-treated group than in the control-treated group ( p the serum sLox-1 and hs-CRP levels were lower in the loading-dose rosuvastatin-treated group than in the control-treated group at 30 days after PCI . However , the decreased values of sLox-1 and hs-CRP from 24 h after PCI to 30 days after PCI did not show any significant difference between the two groups . No significant difference was found in the serum ALT and Scr levels between the two groups before and after PCI . Compared to the control-treated group , the serum BNP level decreased ( p rosuvastatin therapy in elderly patients with non-ST-segment elevation acute coronary syndromes undergoing elective PCI can attenuate the increase in serum hs-CRP , sLox-1 , CK-MB , and cTnI levels , reduce myocardial injury and inflammatory reaction caused by PCI , and improve the LVEF level at 30 days after PCI , ensuring an effective and safe therapy",
"Although substantial evidence suggests that treatment of dyslipidemia with statins reduces mortality and morbidity that are associated with cardiovascular disease , only a few studies have examined the efficacy of statins on inflammatory and fibrinolytic status in patients with chronic kidney disease ( CKD ) . A 6-mo , prospect i ve , r and omized study was design ed to assess the efficacy of atorvastatin in reducing circulating inflammatory and fibrinolytic parameters in patients with CKD . Sixty-six patients with CKD ( stages 2 , 3 , and 4 ) and LDL cholesterol levels > or = 100 mg/dl were r and omly assigned ( 2:1 ) to receive 20 mg/d atorvastatin ( n = 44 ) or nonatorvastatin therapy ( n = 22 ) . Lipid profile , renal function , fibrinolytic balance ( tissue plasminogen activator [ t-PA ] and plasminogen activator inhibitor-1 ) , and inflammatory markers ( C-reactive protein [ CRP ] , IL-1 beta , IL-6 , and TNF-alpha ) were measured before and 6 mo after atorvastatin was added to the treatment . Twenty-five age-matched individuals with normal renal function ( estimated GFR > 90 ml/min ) were used as healthy control subjects . Patients with CKD had higher CRP , IL-1 beta , TNF-alpha , and IL-6 levels than age-matched population with normal renal function . t-PA concentration was higher in patients with CKD ( P = 0.000 ) . Plasminogen activator inhibitor-1 values were comparable in all patients . Total cholesterol and LDL cholesterol were significantly reduced only in patients who received atorvastatin . In addition to the hypolipidemic effect , atorvastatin treatment significantly reduced inflammatory parameters : CRP ( median 4.1 to 2.9 ; P = 0.015 ) , TNF-alpha ( 6.0 + /- 2.7 to 4.7 + /- 2.4 ; P = 0.046 ) , and IL-1 beta levels ( 1.9 + /- 0.7 to 1.2 + /- 0.7 ; P = 0.001 ) . These parameters remained unchanged in patients who were not treated with atorvastatin . Fibrinolytic parameters were not modified by atorvastatin treatment . Patients with CKD showed higher levels of inflammatory parameters and t-PA levels than age-matched healthy control subjects . Atorvastatin treatment , in addition to its beneficial effect on cholesterol levels , improved the inflammatory state of these patients without modifying fibrinolytic balance",
"Atherosclerosis is currently considered a chronic inflammatory disease of the vessel wall . Systemic markers of inflammation have been shown to be of significant prognostic relevance for assessing the risk of atherosclerotic disease progression (1)(2)(3)(4 ) . Previous data showed that proinflammatory markers , such as C-reactive protein ( CRP ) , play an important role in acute coronary events (5)(6)(7 ) and that decreased plasma concentrations of antiinflammatory cytokines , for example , interleukin-10 ( IL-10 ) were also associated with acute coronary syndrome ( ACS ) (8)(9)(10 ) . Statins , 3-hydroxy-3-methyglutaryl-coenzyme A reductase inhibitors , represent a well-established class of drugs that effectively lower serum cholesterol concentrations and are widely used for the treatment of cardiovascular disease (11)(12)(13 ) . In addition to their cholesterol-lowering activity , statins have been demonstrated to possess pleiotropic effects , including antiinflammatory effects (14)(15)(16)(17 ) . Results obtained in numerous investigations have suggested that administration of statins could modify concentrations of CRP and other proinflammatory cytokines with a concurrent decrease in cardiovascular events . However , the potential influence of statins on the antiinflammatory cytokine IL-10 in patients with ACS has not been investigated . In the present study , 42 patients with unstable angina ( UA ) were r and omly assigned immediately after admission to st and ard therapy plus either 20 mg/day atorvastatin or placebo . The st and ard therapy included aspirin , beta-blockers , heparin/low – molecular-weight heparin , angiotensin-converting enzyme inhibitors , and oral nitrates . The protocol s of the study were approved by the Ethics Review Board of the Hospital , and all patients gave written , informed consent . The patients with UA presented with ischemic chest pain at rest in the absence of extracardiac cause with ST-segment depression ≥0.1 mV in 2 or more contiguous leads on 12-lead electrocardiograms at administration . Echocardiography was performed in all patients to exclude patients with an impaired left",
"BACKGROUND Patients on regular hemodialysis present high cardiovascular mortality . Uremic dyslipidemia and inflammation take part in the etiology of atherosclerosis . Rosuvastatin calcium has not been studied in patients on dialysis to date . We sought to evaluate the results of rosuvastatin therapy regarding lipids , lipoproteins and a marker of inflammation in hemodialysis patients . METHODS In a double-blind r and omized placebo-controlled trial , 59 patients on hemodialysis ( 31 in the placebo group , and 28 taking rosuvastatin 10 mg/day ) were followed for 3 months . Lipids , lipoproteins and high-sensitivity C-reactive protein ( hs-CRP ) were measured at baseline , 30 days and 3 months . RESULTS In the rosuvastatin group , there was a significant decrease from baseline to the study end in total cholesterol ( 163+/-53 mg/dL to 142+/-43 mg/dL ; p LDL cholesterol ( 90+/-39 mg/dL to 69+/-32 mg/dL ; p non-HDL cholesterol ( 121+/-46 mg/dL to 99+/-39 mg/dL ; p placebo group , no significant decrease was observed . High-sensitivity CRP was lower in the rosuvastatin than in the placebo group at 3 months ( p Rosuvastatin calcium at 10 mg/day was effective in lowering total cholesterol , LDL cholesterol , non-HDL cholesterol and hs-CRP in hemodialysis patients",
"AIMS Abnormalities of microvascular and endothelial function are present in subjects with Type 2 diabetes . Although statin therapy improves cardiovascular risk in diabetes , dyslipidaemia in diabetes may be more responsive to combined statin and fibrate therapy . We examined the effect of cerivastatin and fenofibrate on microvascular function in subjects with Type 2 diabetes with no clinical evidence of cardiovascular disease and near normal lipid levels . METHODS Age- , sex- , lipid- and blood pressure-matched subjects with Type 2 diabetes were r and omized in double-blind fashion to one of four treatment groups : group 1 placebo/placebo ( n=12 ) , group 2 fenofibrate/placebo ( n=10 ) , group 3 cerivastatin/placebo ( n=20 ) and group 4 cerivastatin/fenofibrate ( n=11 ) . The subjects were recruited from the Lipid in Diabetes Study . Microvascular function was assessed by skin blood flow response to iontophoresis of acetylcholine and sodium nitroprusside and by skin maximum hyperaemia to local heating . Measurements were carried out at baseline and 3 months later . RESULTS Although all lipid parameters improved in groups 2 - 4 after 3 months ' therapy , no difference was detected in skin blood flow to iontophoresis or maximum hyperaemia in any of the groups . Highly sensitive c-reactive protein ( Hs-CRP ) did not change with therapy . CONCLUSIONS In conclusion , we were unable to demonstrate any improvement in microvascular endothelial function in non-hyperlipidaemic Type 2 diabetic subjects treated with single or combination lipid-lowering therapy",
"PURPOSE The beneficial effect of rosuvastatin against percutaneous coronary intervention ( PCI ) related procedural myocardial injury has been determined mostly in patients with acute coronary syndromes ( ACS ) . However , the detailed therapeutic mechanism has not been well studied . METHODS Patients with ACS receiving PCI ( n = 159 ) were r and omized to control group ( placebo treatment ) or to rosuvastatin group ( 20 mg 12 h before PCI , and a further 20 mg 2 h preprocedure dose ) . Levels of INF-γ , TNF-α , IL-6 , miR-155/SHIP-1 , and CD4(+)FoxP3(+)Treg in peripheral blood were detected before PCI and 24 h after PCI . Clinical data of these patients were also collected in this prospect i ve study . RESULTS Compared with placebo , rosuvastatin treatment significantly reduced the incidence of periprocedural myocardial infa rct ion ( PMI ) and levels of cardiac troponin I ( cTnI ) associated with decreased relative expression of serum miR-155 , levels of inflammatory cytokines ( INF-γ , TNF-α , and IL-6 ) , increased SHIP-1 expression and CD4(+)FoxP3(+)Treg percentage values ( P with rosuvastatin pretreatment also reduced incidence of 30 days major adverse cardiac events ( MACE ) compared to the patients with placebo treatment ( 16 patients vs. 28 patients , P = 0.038 ) . CONCLUSIONS Our study suggests that high loading dose rosuvastatin pretreatment may reduce the incidence of cardiovascular events and levels of inflammatory markers in patients with ACS receiving PCI , which may be explained at least in part , by mechanism involving suppression of miR-155/SHIP-1 signaling pathway",
"Aims Type 1 diabetes mellitus patients with microalbuminuria have endothelial dysfunction associated with the degree of albuminuria but not with LDL‐cholesterol levels . Lipid‐lowering agents such as statins may still be of benefit as they can correct endothelial dysfunction by both lipid and non‐lipid mechanisms . We therefore examined the effects of atorvastatin on brachial artery endothelial dysfunction in these patients",
"BACKGROUND C-reactive protein ( CRP ) levels are associated with cardiovascular risk . We assessed the hypothesis that atorvastatin might have anti-inflammatory effects in acute coronary syndromes ( ACS ) as shown by CRP reduction . METHODS This study was a prospect i ve , r and omized , double-blind , placebo-controlled study of 90 consecutive patients admitted within 48 hours of onset of ACS with CRP levels > or = 1.4 mg/dL. Patients were assigned to atorvastatin 40 mg daily or placebo over 30 days . C-reactive protein levels , lipid profiles , serum fibrinogen , white cell count , and erythrocyte sedimentation rate were measured at entry , hospital discharge , and 1 month later . RESULTS Baseline clinical characteristics did not differ between atorvastatin and placebo groups ( mean age 59.3 + /- 13.4 vs 61.1 + /- 11.5 , P = ns ) ; myocardial infa rct ion 52.3 % versus 67.4 % ( P = ns ) . In both groups , median baseline CRP levels were comparable ( 5.97 + /- 6.2 vs 4.64 + /- 4.2 mg/dL , P = ns ) . C-reactive protein levels were lower in the atorvastatin group versus control group at discharge ( 1.68 + /- 1.65 vs 4.12 + /- 4.18 mg/dL ) and at 30 days ( 0.50 + /- 0.71 vs 2.91 + /- 2.68 mg/dL , both P C-reactive protein levels significantly decreased from baseline to discharge and 1 month later in placebo and atorvastatin groups ( both P atorvastatin group ( 62 % vs 11 % at discharge [ P atorvastatin was associated with a reduction in total and low-density lipoprotein cholesterol and erythrocyte sedimentation rate at discharge and at 30 days ( P CRP and cholesterol levels . CONCLUSIONS C-reactive protein levels in ACS were rapidly reduced with atorvastatin . These data provide evidence that statins have fast and early anti-inflammatory effects in addition to lipid-lowering effects in ACS",
"OBJECTIVE Although previous studies suggest that treatment of dyslipidemia with statins reduces mortality and morbidity that are associated with cardiovascular disease , only a few studies have examined the efficacy of statins on atherosclerotic status in patients with chronic kidney disease ( CKD ) . MATERIAL S AND METHODS A 12-month , prospect i ve , r and omized study was design ed to assess the efficacy of rosuvastatin in reducing circulating atherosclerotic parameters and renal function in patients with CKD . Thirty-eight patients with CKD and LDL cholesterol levels > or = 100 mg/dL were r and omly assigned to receive 2.5 mg/dL rosuvastatin ( group A , n=22 ) or nonrosuavastatin therapy ( group B , n=16 ) . Lipid profile , estimated glomerular filtration rate ( eGFR ) , high sensitivity C-reactive protein ( hs-CRP ) , and intima-media thickness ( IMT ) were measured before and 12 months after rosuvastatin was added to the treatment . RESULTS Total cholesterol , low-density lipoprotein cholesterol , remnant-like particle-cholesterol and triglycerides were significantly reduced only in patients who received rosuvastatin . These parameters remained unchanged in patients who were not treated with rosuvastatin . eGFR was significantly increased from 50.7+/-18.7 mL/min/1.73 m(2 ) to 53.3+/-20.1 mL/min/1.73 m(2 ) and a significant reduction of U-P was detected in group A patients ( 0.17+/-0.29 vs. 0.13+/-0.3 g/day ; p rosuvastatin treatment significantly reduced hs-CRP ( p=0.0054 ) . Moreover , maximal IMT at the baseline ( 1.89+/-0.98 mm ) decreased significantly to 1.75+/-0.87 mm at 12 months ( p=0.0231 ) . CONCLUSION Rosuvastatin treatment , in addition to its beneficial effect on cholesterol levels , reduced maximal IMT and modified the inflammatory state of these patients",
"BACKGROUND The effects of statin therapy on the production of monocyte pro-inflammatory cytokines , cardiac function and the long-term prognosis in chronic heart failure ( CHF ) patients with dyslipidemia remain unclear . METHODS AND RESULTS A total of 146 CHF patients with a mean left ventricular ejection fraction ( LVEF ) of 26.9 ± 6.6 % were divided into 2 groups based on whether or not statins were included in their treatment : a statin group ( n=63 ) and a no statin group ( n=83 ) . Only patients with dyslipidemia were treated with statins . Peripheral blood mononuclear cells ( P BMC s ) were isolated , and the production of monocyte tumor necrosis factor (TNF)-α and interleukin (IL)-6 were measured at baseline and after 6 months of treatment , and the data expressed as mean ± SD ( pg·ml(-1)·10(-6 ) P BMC s ) . The LVEF in the statin group improved , and the monocyte TNF-α and IL-6 production decreased ( respectively , P the LVEF and cytokine production remained unchanged in the no statin group . Multivariate Cox hazard analysis showed that statin therapy ( hazard ratio , 0.14 ; 95 % confidence interval : 0.02 - 0.97 , P=0.046 ) was an independent predictor of cardiac events . CONCLUSIONS Statin therapy attenuates the production of monocyte pro-inflammatory cytokines , and ameliorates the cardiac function and may improve long-term prognosis in CHF patients with dyslipidemia",
"Anemia is a common clinical problem in end-stage renal disease ( ESRD ) . Despite adequate erythropoiesis-stimulating agent ( ESA ) supplementation , some ESRD patients still have suboptimal hemoglobin levels , and iron deficiency and inflammation are recognized as the two most common causes . Hepcidin , a newly discovered key regulator of iron homeostasis , is found to be accumulated in ESRD . As it controls iron uptake and release , better reflecting real-time iron dem and and availability , hepcidin might become a target in the management of iron deficiency and ESA resistance in dialysis patients . For their pleiotropic functions apart from lipid-modulation , statins are also used as anti-inflammatory or immune-modulating agents . In this study , we applied simvastatin for the purpose of influencing serum prohepcidin level in a group of maintenance hemodialysis patients . Thirty-three ESRD patients undergoing hemodialysis were enrolled and assigned to experimental and hemodialysis control groups according to their lipid profile . Nineteen healthy adults were chosen as a normal control group . The subjects in the experimental group took 20 mg simvastatin orally per night for eight weeks , and those in the hemodialysis control group took no statins or any other lipid-modulating drugs . Before and after the experiment , the serum prohepcidin concentrations , plasma IL-6 , and serum C-reactive protein ( CRP ) , ferritin , hemoglobin , albumin , total cholesterol , glycerinate , and LDL and HDL cholesterol levels were determined . Of the 33 hemodialysis patients , the serum prohepcidin concentration was ( 175.8 + /- 52.9 ) ng/mL , significantly higher than that in the normal control group ( 149.5 + /- 24.2 ) ng/mL ( P = 0.048 ) . In the experimental group , the serum prohepcidin level was ( 156.7 + /- 51.9 ) ng/mL before treatment , and ( 190.6 + /- 49.6 ) ng/mL after eight weeks ( P = 0.127 ) . In the hemodialysis control group , the serum prohepcidin level was ( 190.6 + /- 49.6 ) ng/mL at the beginning , and ( 193.5 + /- 36.0 ) ng/mL after eight weeks ( P = 0.728 ) . In the experimental group , after taking simvastatin for eight weeks the serum total cholesterol and triglyceride levels had lowered by 18.6 % ( P = 0.004 ) and 55.1 % ( P = 0.007 ) , respectively . The plasma IL-6 , serum CRP , ferritin , hemoglobin , albumin , and LDL and HDL cholesterol levels in both the hemodialysis group remained unchanged . According to our preliminary study , eight weeks of 20 mg simvastatin did not significantly change the serum prohepcidin , high-sensitive CRP , or IL-6 concentrations in the group of maintenance hemodialysis patients",
"Abstract Background : Periprocedural myocardial infa rct ion ( MI ) is a common complication following percutaneous coronary intervention ( PCI ) and statins have been shown to reduce MI in statin-naïve patients . We aim ed to identify whether a high reloading dose of atorvastatin can prevent MI following PCI in patients who were already being treated with statins . Material and methods : In this triple-blind controlled r and omized clinical trial , 190 c and i date s for elective PCI , who were already using statins and /or other lipid lowering agents such as fibrates , were r and omly assigned to two equal groups to receive either atorvastatin ( 80 mg ) or placebo within 24 hours before the procedure . Serum levels of creatinine kinase myocardial isoenzyme ( CK-MB ) , cardiac troponin I ( cTNI ) and high-sensitive C-reactive protein ( hs-CRP ) were measured at baseline and then 6 and 12 hours following PCI . Post-procedural MI was defined as troponin elevation > 5-fold in patients with normal baseline or > 20 % in those with elevated baseline measurements with or without chest pain or ST segment or T wave abnormalities . Results : Frequency of MI in the atorvastatin group was 3 ( 3.1 % ) vs. 10 ( 10.5 % ) in the placebo group ( p = 0.04 ) . The CK-MB rise within 6 hours following PCI was 0.6 ± 0.3 mg/dl in the intervention group versus 3.0 ± 1.6 mg/dl in the placebo group . Also , the levels of cTNI within 6 and 12 hours in the intervention group was significantly lower than the placebo group ( p = 0.01 and 0.008 , respectively ) . hs-CRP was significantly lower in the intervention group after 12 hours ( p = 0.004 ) . Conclusion : Administration of a high reloading dose of atorvastatin within 24 hours before PCI could significantly reduce the frequency of periprocedural MI . Clinical trial registration code : I RCT 201205209768N1"
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BACKGROUND It is currently unclear whether altering the carbohydrate-to-protein ratio of low-fat , energy-restricted diets augments weight loss and cardiometabolic risk markers . OBJECTIVE The objective was to conduct a systematic review and meta- analysis of studies that compared energy-restricted , isocaloric , high-protein , low-fat ( HP ) diets with st and ard-protein , low-fat ( SP ) diets on weight loss , body composition , resting energy expenditure ( REE ) , satiety and appetite , and cardiometabolic risk factors . DESIGN Systematic search es were conducted by using MEDLINE , EMBASE , PubMed , and the Cochrane Central Register of Controlled Trials to identify weight-loss trials that compared isocalorically prescribed diets matched for fat intake but that differed in protein and carbohydrate intakes in participants aged ≥18 y. Twenty-four trials that included 1063 individuals satisfied the inclusion criteria . RESULTS Mean ( ±SD ) diet duration was 12.1 ± 9.3 wk . Compared with an SP diet , an HP diet produced more favorable changes in weighted mean differences for reductions in body weight ( -0.79 kg ; 95 % CI : -1.50 , -0.08 kg ) , fat mass ( FM ; -0.87 kg ; 95 % CI : -1.26 , -0.48 kg ) , and triglycerides ( -0.23 mmol/L ; 95 % CI : -0.33 , -0.12 mmol/L ) and mitigation of reductions in fat-free mass ( FFM ; 0.43 kg ; 95 % CI : 0.09 , 0.78 kg ) and REE ( 595.5 kJ/d ; 95 % CI : 67.0 , 1124.1 kJ/d ) . Changes in fasting plasma glucose , fasting insulin , blood pressure , and total , LDL , and HDL cholesterol were similar across dietary treatments ( P ≥ 0.20 ) . Greater satiety with HP was reported in 3 of 5 studies . CONCLUSION Compared with an energy-restricted SP diet , an isocalorically prescribed HP diet provides modest benefits for reductions in body weight , FM , and triglycerides and for mitigating reductions in FFM and REE
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"OBJECTIVE To investigate whether protein intake influences the decline in energy expenditure during energy restriction . DESIGN Cross-over study of three diets of 4.2 MJ/d for 7 days : one diet with 36 % energy as protein and two with 15 % energy as protein , one high in carbohydrate and the other high in fat . SUBJECTS Two men and six women aged 31 - 57 y. BMI 27.B-34.1 kg/m2 . MEASUREMENTS 24-h energy expenditure ( 24-h EE ) , sleeping metabolic rate ( SMR ) and body weight on days 0 and 7 of each diet ; 24-h urinary nitrogen excretion ( 24-h UN ) on days 0 - 7 of each diet . RESULTS 24-h EE and SMR declined on all three diets but the decrease was significantly less on the high protein diet than on the two low protein diets . Weight loss was similar on all three diets . 24-h UN was less than N intake on the high protein diet but greater than N intake on the two low protein diets . CONCLUSIONS Maintaining protein intake reduces the decrease in energy expenditure during energy restriction",
"BACKGROUND Higher protein diets are promoted for effective weight loss . Striated tissues in omnivorous diets contain high- quality protein , but limited data exist regarding their effects on bone . METHODS To examine the effects of energy restriction-induced weight loss with higher protein omnivorous diets versus lower protein vegetarian diets on bone mineral density in overweight postmenopausal women , two r and omized controlled feeding studies were conducted . In Study 1 , 28 women consumed 750 kcal/day energy deficit diets with 18 % energy from protein via lacto-ovo vegetarian sources ( normal protein , n = 15 ) or 30 % energy from protein with 40 % of protein from lean pork ( higher protein , n = 13 , omnivorous ) for 12 weeks . In Study 2 , 54 women consumed their habitual diet ( control , n = 11 ) or 1,250 kcal/day diets with 16 % energy from nonmeat protein sources ( n = 14 ) or 26 % energy from protein , including chicken ( n = 15 ) or beef ( n = 14 ) for 9 weeks . RESULTS Study 1 : With weight loss ( normal protein -11.2 % , higher protein -10.1 % ) , bone mineral density was not significantly changed in normal protein ( -0.003 ± 0.003 g/cm(2 ) , -0.3 % ) but decreased in higher protein ( -0.0167 ± 0.004 g/cm(2 ) , -1 . 4 % , group-by-time p The change of bone mineral density was significant for chicken and beef compared with the control ( group-by-time , p .05 ) . Markers of calcium metabolism and bone homeostasis in blood and urine were not changed over time or differentially affected by diet . CONCLUSION Consumption of higher protein omnivorous diets promoted decreased bone mineral density after weight loss in overweight postmenopausal women",
"OBJECTIVE To compare the effects of protein vs. simple sugars on weight loss , body composition , and metabolic and endocrine parameters in polycystic ovary syndrome ( PCOS ) . DESIGN A 2-month , free-living , r and omized , single-blinded study . SETTING University PCOS clinic . PATIENT(S ) Thirty-three patients with PCOS . INTERVENTION(S ) To achieve a final energy reduction of 450 kcal/day , first the daily energy intake was reduced by 700 kcal ; then a 240-kcal supplement containing either whey protein or simple sugars was added . MAIN OUTCOME MEASURE(S ) Changes in weight , fat mass , fasting glucose and insulin , plasma lipoproteins , and sex steroids . RESULT ( S ) Twenty-four subjects ( 13 in the simple sugars group and 11 in the protein group ) completed the study . The protein group lost more weight ( -3.3 + /- 0.8 kg vs. -1.1 + /- 0.6 kg ) and more fat mass ( -3.1 + /- 0.9 kg vs. -0.5 + /- 0.6 kg ) and had larger decreases in serum cholesterol ( -33.0 + /- 8.4 mg/dL vs. -2.3 + /- 6.8 mg/dL ) , high-density lipoprotein cholesterol ( -4.5 + /- 1.3 mg/dL vs. -0.4 + /- 1.3 mg/dL ) , and apoprotein B ( -20 + /- 5 mg/dL vs. 3 + /- 5 mg/dL ) . CONCLUSION ( S ) In patients with PCOS , a hypocaloric diet supplemented with protein reduced body weight , fat mass , serum cholesterol , and apoprotein B more than the diet supplemented with simple sugars",
"BACKGROUND Studies of weight-control diets that are high in protein or low in glycemic index have reached varied conclusions , probably owing to the fact that the studies had insufficient power . METHODS We enrolled overweight adults from eight European countries who had lost at least 8 % of their initial body weight with a 3.3-MJ ( 800-kcal ) low-calorie diet . Participants were r and omly assigned , in a two-by-two factorial design , to one of five ad libitum diets to prevent weight regain over a 26-week period : a low-protein and low-glycemic-index diet , a low-protein and high-glycemic-index diet , a high-protein and low-glycemic-index diet , a high-protein and high-glycemic-index diet , or a control diet . RESULTS A total of 1209 adults were screened ( mean age , 41 years ; body-mass index [ the weight in kilograms divided by the square of the height in meters ] , 34 ) , of whom 938 entered the low-calorie-diet phase of the study . A total of 773 participants who completed that phase were r and omly assigned to one of the five maintenance diets ; 548 completed the intervention ( 71 % ) . Fewer participants in the high-protein and the low-glycemic-index groups than in the low-protein-high-glycemic-index group dropped out of the study ( 26.4 % and 25.6 % , respectively , vs. 37.4 % ; P=0.02 and P=0.01 for the respective comparisons ) . The mean initial weight loss with the low-calorie diet was 11.0 kg . In the analysis of participants who completed the study , only the low-protein-high-glycemic-index diet was associated with subsequent significant weight regain ( 1.67 kg ; 95 % confidence interval [ CI ] , 0.48 to 2.87 ) . In an intention-to-treat analysis , the weight regain was 0.93 kg less ( 95 % CI , 0.31 to 1.55 ) in the groups assigned to a high-protein diet than in those assigned to a low-protein diet ( P=0.003 ) and 0.95 kg less ( 95 % CI , 0.33 to 1.57 ) in the groups assigned to a low-glycemic-index diet than in those assigned to a high-glycemic-index diet ( P=0.003 ) . The analysis involving participants who completed the intervention produced similar results . The groups did not differ significantly with respect to diet-related adverse events . CONCLUSIONS In this large European study , a modest increase in protein content and a modest reduction in the glycemic index led to an improvement in study completion and maintenance of weight loss . ( Funded by the European Commission ; Clinical Trials.gov number , NCT00390637 . )",
"Background To evaluate the metabolic effects of two weight loss diets differing in macronutrient composition on features of dyslipidemia and post-pr and ial insulin ( INS ) response to a meal challenge in overweight/obese individuals . Methods This study was a parallel-arm r and omized 4 mo weight loss trial . Adults ( n = 50 , 47 ± 7 y ) matched on BMI ( 33.6 ± 0.6 kg/m2 , P = 0.79 ) consumed energy restricted diets ( deficit ~500 kcal/d ) : PRO ( 1.6 g.kg-1.d-1 protein and or CHO ( 0.8 g.kg-1.d-1 protein and > 220 g/d carbohydrate ) for 4 mos . Meal challenges of respective diets were utilized for determination of blood lipids and post-pr and ial INS and glucose response at the beginning and end of the study . Results There was a trend for PRO to lose more weight ( -9.1 % vs. -7.3 % , P = 0.07 ) with a significant reduction in percent fat mass compared to CHO ( -8.7 % vs. -5.7 % ; P = 0.03 ) . PRO also favored reductions in triacylglycerol ( -34 % vs. -14 % ; P HDL-C ( + 5 % vs. -3 % ; P = 0.05 ) ; however , CHO favored reduction in LDL-C ( -7 % vs. + 2.5 % ; P INS responses to the meal challenge were improved in PRO compared to CHO ( P loss diet with moderate carbohydrate , moderate protein results in more favorable changes in body composition , dyslipidemia , and post-pr and ial INS response compared to a high carbohydrate , low protein diet suggesting an additional benefit beyond weight management to include augmented risk reduction for metabolic disease",
"Although popular and effective for weight loss , low-carbohydrate , high-protein , high-fat ( Atkins ) diets have been associated with adverse changes in blood and renal biomarkers . High-protein diets low in fat may represent an equally appealing diet plan but promote a more healthful weight loss . Healthy adults ( n = 20 ) were r and omly assigned to 1 of 2 low-fat ( ( 30 % energy ) or high-carbohydrate ( 60 % energy ) ; 24-h intakes were strictly controlled during the 6-wk trial . One subject from each group did not complete the trial due to out-of-state travel ; two subjects in the high-carbohydrate group withdrew from the trial due to extreme hunger . Body composition and metabolic indices were assessed pre- and post-trial . Both diets were equally effective at reducing body weight ( -6 % , P fat mass ( -9 to -11 % , P satisfaction and less hunger in mo 1 of the trial . Both diets significantly lowered total cholesterol ( -10 to -12 % ) , insulin ( -25 % ) , and uric acid ( -22 to -30 % ) concentrations in blood from fasting subjects . Urinary calcium excretion increased 42 % in subjects consuming the high-protein diet , mirroring the 50 % increase in dietary calcium with consumption of this diet ; thus , apparent calcium balance was not adversely affected . Creatinine clearance was not altered by diet treatments , and nitrogen balance was more positive in subjects consuming the high-protein diet vs. the high-carbohydrate diet ( 3.9 + /- 1.4 and 0.7 + /- 1.7 g N/d , respectively , P low-fat , energy-restricted diets of varying protein content ( 15 or 30 % energy ) promoted healthful weight loss , but diet satisfaction was greater in those consuming the high-protein diet",
"Cl aims about the merits or risks of carbohydrate ( CHO ) vs. protein for weight loss diets are extensive , yet the ideal ratio of dietary carbohydrate to protein for adult health and weight management remains unknown . This study examined the efficacy of two weight loss diets with modified CHO/protein ratios to change body composition and blood lipids in adult women . Women ( n = 24 ; 45 to 56 y old ) with body mass indices > 26 kg/m(2 ) were assigned to either a CHO Group consuming a diet with a CHO/protein ratio of 3.5 ( 68 g protein/d ) or a Protein Group with a ratio of 1.4 ( 125 g protein/d ) . Diets were isoenergetic , providing 7100 kJ/d , and similar amounts of fat ( approximately 50 g/d ) . After consuming the diets for 10 wk , the CHO Group lost 6.96 + /- 1.36 kg body weight and the Protein Group lost 7.53 + /- 1.44 kg . Weight loss in the Protein Group was partitioned to a significantly higher loss of fat/lean ( 6.3 + /- 1.2 g/g ) compared with the CHO Group ( 3.8 + /- 0.9 ) . Both groups had significant reductions in serum cholesterol ( approximately 10 % ) , whereas the Protein Group also had significant reductions in triacylglycerols ( TAG ) ( 21 % ) and the ratio of TAG/HDL cholesterol ( 23 % ) . Women in the CHO Group had higher insulin responses to meals and postpr and ial hypoglycemia , whereas women in the Protein Group reported greater satiety . This study demonstrates that increasing the proportion of protein to carbohydrate in the diet of adult women has positive effects on body composition , blood lipids , glucose homeostasis and satiety during weight loss",
"This study examined the interaction of 2 diets ( high protein , reduced carbohydrates vs. low protein , high carbohydrates ) with exercise on body composition and blood lipids in women ( n = 48 , approximately 46 y old , BMI = 33 kg/m(2 ) ) during weight loss . The study was a 4-mo weight loss trial using a 2 x 2 block design ( Diet x Exercise ) . Diets were equal in total energy ( 7.1 MJ/d ) and lipids ( approximately 30 % energy intake ) but differed in protein content and the ratio of carbohydrate : protein at 1.6 g/(kg . d ) and 3.5 ( CHO group ) , respectively . Exercise comparisons were lifestyle activity ( control ) vs. a supervised exercise program ( EX : 5 d/wk walking and 2 d/wk resistance training ) . Subjects in the PRO and PRO + EX groups lost more total weight and fat mass and tended to lose less lean mass ( P = 0.10 ) than the CHO and CHO + EX groups . Exercise increased loss of body fat and preserved lean mass . The combined effects of diet and exercise were additive for improving body composition . Serum lipid profiles improved in all groups , but changes varied among diet treatments . Subjects in the CHO groups had larger reductions in total cholesterol and LDL cholesterol , whereas subjects in the PRO groups had greater reductions in triacylglycerol and maintained higher concentrations of HDL cholesterol . This study demonstrated that a diet with higher protein and reduced carbohydrates combined with exercise additively improved body composition during weight loss , whereas the effects on blood lipids differed between diet treatments",
"BACKGROUND It is not clear whether varying the protein-to-carbohydrate ratio of weight-loss diets benefits body composition or metabolism . OBJECTIVE The objective was to compare the effects of 2 weight-loss diets differing in protein-to-carbohydrate ratio on body composition , glucose and lipid metabolism , and markers of bone turnover . DESIGN A parallel design included either a high-protein diet of meat , poultry , and dairy foods ( HP diet : 27 % of energy as protein , 44 % as carbohydrate , and 29 % as fat ) or a st and ard-protein diet low in those foods ( SP diet : 16 % of energy as protein , 57 % as carbohydrate , and 27 % as fat ) during 12 wk of energy restriction ( 6 - 6.3 MJ/d ) and 4 wk of energy balance ( approximately 8.2 MJ/d ) . Fifty-seven overweight volunteers with fasting insulin concentrations > 12 mU/L completed the study . RESULTS Weight loss ( 7.9 + /- 0.5 kg ) and total fat loss ( 6.9 + /- 0.4 kg ) did not differ between diet groups . In women , total lean mass was significantly ( P = 0.02 ) better preserved with the HP diet ( -0.1 + /- 0.3 kg ) than with the SP diet ( -1.5 + /- 0.3 kg ) . Those fed the HP diet had significantly ( P glycemic response at weeks 0 and 16 than did those fed the SP diet . After weight loss , the glycemic response decreased significantly ( P serum triacylglycerol concentrations was significantly ( P HP diet group ( 23 % ) than in the SP diet group ( 10 % ) . Markers of bone turnover , calcium excretion , and systolic blood pressure were unchanged . CONCLUSION Replacing carbohydrate with protein from meat , poultry , and dairy foods has beneficial metabolic effects and no adverse effects on markers of bone turnover or calcium excretion",
"BACKGROUND Low-carbohydrate diets have been used to manage obesity and its metabolic consequences . OBJECTIVE The objective was to study the effects of moderate carbohydrate restriction on atherogenic dyslipidemia before and after weight loss and in conjunction with a low or high dietary saturated fat intake . DESIGN After 1 wk of consuming a basal diet , 178 men with a mean body mass index ( in kg/m(2 ) ) of 29.2 + /- 2.0 were r and omly assigned to consume diets with carbohydrate contents of 54 % ( basal diet ) , 39 % , or 26 % of energy and with a low saturated fat content ( 7 - 9 % of energy ) ; a fourth group consumed a diet with 26 % of energy as carbohydrate and 15 % as saturated fat . After 3 wk , the mean weight loss ( 5.12 + /- 1.83 kg ) was induced in all diet groups by a reduction of approximately 1000 kcal/d for 5 wk followed by 4 wk of weight stabilization . RESULTS The 26%-carbohydrate , low-saturated-fat diet reduced triacylglycerol , apolipoprotein B , small LDL mass , and total : HDL cholesterol and increased LDL peak diameter . These changes were significantly different from those with the 54%-carbohydrate diet . After subsequent weight loss , the changes in all these variables were significantly greater and the reduction in LDL cholesterol was significantly greater with the 54%-carbohydrate diet than with the 26%-carbohydrate diet . With the 26%-carbohydrate diet , lipoprotein changes with the higher saturated fat intakes were not significantly different from those with the lower saturated fat intakes , except for LDL cholesterol , which decreased less with the higher saturated fat intake because of an increase in mass of large LDL . CONCLUSIONS Moderate carbohydrate restriction and weight loss provide equivalent but nonadditive approaches to improving atherogenic dyslipidemia . Moreover , beneficial lipid changes result ing from a reduced carbohydrate intake were not significant after weight loss",
"BACKGROUND The anabolic effect of resistance exercise is enhanced by the provision of dietary protein . OBJECTIVES We aim ed to determine the ingested protein dose response of muscle ( MPS ) and albumin protein synthesis ( APS ) after resistance exercise . In addition , we measured the phosphorylation of c and i date signaling proteins thought to regulate acute changes in MPS . DESIGN Six healthy young men reported to the laboratory on 5 separate occasions to perform an intense bout of leg-based resistance exercise . After exercise , participants consumed , in a r and omized order , drinks containing 0 , 5 , 10 , 20 , or 40 g whole egg protein . Protein synthesis and whole-body leucine oxidation were measured over 4 h after exercise by a primed constant infusion of [1-(13)C]leucine . RESULTS MPS displayed a dose response to dietary protein ingestion and was maximally stimulated at 20 g. The phosphorylation of ribosomal protein S6 kinase ( Thr(389 ) ) , ribosomal protein S6 ( Ser(240/244 ) ) , and the epsilon-subunit of eukaryotic initiation factor 2B ( Ser(539 ) ) were unaffected by protein ingestion . APS increased in a dose-dependent manner and also reached a plateau at 20 g ingested protein . Leucine oxidation was significantly increased after 20 and 40 g protein were ingested . CONCLUSIONS Ingestion of 20 g intact protein is sufficient to maximally stimulate MPS and APS after resistance exercise . Phosphorylation of c and i date signaling proteins was not enhanced with any dose of protein ingested , which suggested that the stimulation of MPS after resistance exercise may be related to amino acid availability . Finally , dietary protein consumed after exercise in excess of the rate at which it can be incorporated into tissue protein stimulates irreversible oxidation",
"OBJECTIVE : To study the effect on weight loss in obese subjects by replacement of carbohydrate by protein in ad libitum consumed fat-reduced diets . DESIGN : R and omized dietary intervention study over six months comparing two ad libitum fat reduced diets ( 30 % of total energy ) strictly controlled in composition : High-carbohydrate ( HC , protein 12 % of total energy ) or high-protein ( HP , protein 25 % of total energy ) . SETTING AND PARTICIPANTS : Subjects were 65 healthy , overweight and obese subjects ( 50 women , 15 men , aged 18–55 y ) r and omly assigned to HC ( n=25 ) , HP ( n=25 ) or a control group ( C , n=15 ) . All food was provided by self- selection in a shop at the department , and compliance to the diet composition was evaluated by urinary nitrogen excretion . MAIN OUTCOME MEASURE : Change in body weight , body composition and blood lipids . RESULTS : More than 90 % completed the trial . Weight loss after six months was 5.1 kg in the HC group and 8.9 kg in the HP group ( difference 3.7 kg , 95 % confidence interval (CI)(1.3–6.2 kg ) P and fat loss was 4.3 kg and 7.6 kg , respectively ( difference 3.3 kg ( 1.1–5.5 kg ) P lost > 10 kg in the HP group ( 35 % ) than in the HC group ( 9 % ) . The HP diet only decreased fasting plasma triglycerides and free fatty acids significantly . CONCLUSIONS : Replacement of some dietary carbohydrate by protein in an ad libitum fat-reduced diet , improves weight loss and increases the proportion of subjects achieving a clinical ly relevant weight loss . More freedom to choose between protein-rich and complex carbohydrate-rich foods may allow obese subjects to choose more lean meat and dairy products , and hence improve adherence to low-fat diets in weight reduction programs",
"OBJECTIVE : To determine the effect of replacing some dietary carbohydrate with protein , during energy restriction , on weight loss , total energy expenditure ( TEE ) , resting energy expenditure ( REE ) , respiratory quotient ( RQ ) , and the thermic effect of feeding ( TEF ) in subjects with hyperinsulinemia . DESIGN : Parallel , clinical intervention study of 12 weeks energy restriction ( 6.5 MJ/day ) and 4 weeks energy balance ( 8.2 MJ/day ) in two groups of subjects r and omly assigned to either a high-protein ( HP ) diet ( 27 % of energy ( % E ) as protein , 45%E as carbohydrate ) or a lower-protein ( LP ) diet ( 16%E as protein , 57%E as carbohydrate).SUBJECTS : A total of 36 obese nondiabetic volunteers with hyperinsulinemia ( 10 males/26 females , aged 34–65 y , BMI 28–43 kg/m2 , fasting insulin 12–45 mU/l ) . MEASUREMENTS : Body weight and composition , TEE , REE , and RQ were measured at baseline and at week 16 . In addition , the TEF to an HP or LP meal was determined for 3 h , at baseline and at week 16 . RESULTS : After 16 weeks , weight loss was similar in response to each diet ; the overall decrease was 7.9±0.6 kg ( P P REE fell similarly with each diet ; the overall decrease was 719±106 kJ/day ( P ) . The TEF was 2 % greater after the HP than after the LP meal at baseline ( P , the TEF was not reduced in either dietary group . There was no change in TEE after 16 weeks . CONCLUSION : In subjects with hyperinsulinemia an energy-restrictive diet containing an increased protein-to-carbohydrate ratio does not enhance weight loss or significantly affect energy expenditure . Caloric restriction , rather than the macronutrient composition of the diet , is the most important determinant of weight loss",
"BACKGROUND Limited evidence suggests that a higher ratio of protein to carbohydrate during weight loss has metabolic advantages . OBJECTIVE The objective was to evaluate the effects of a diet with a high ratio of protein to carbohydrate during weight loss on body composition , cardiovascular disease risk , nutritional status , and markers of bone turnover and renal function in overweight women . DESIGN The subjects were r and omly assigned to 1 of 2 isocaloric 5600-kJ dietary interventions for 12 wk according to a parallel design : a high-protein ( HP ) or a high-carbohydrate ( HC ) diet . RESULTS One hundred women with a mean ( + /-SD ) body mass index ( in kg/m(2 ) ) of 32 + /- 6 and age of 49 + /- 9 y completed the study . Weight loss was 7.3 + /- 0.3 kg with both diets . Subjects with high serum triacylglycerol ( > 1.5 mmol/L ) lost more fat mass with the HP than with the HC diet ( x + /- SEM : 6.4 + /- 0.7 and 3.4 + /- 0.7 kg , respectively ; P = 0.035 ) and had a greater decrease in triacylglycerol concentrations with the HP ( -0.59 + /- 0.19 mmol/L ) than with the HC ( -0.03 + /- 0.04 mmol/L ) diet ( P = 0.023 for diet x triacylglycerol interaction ) . Triacylglycerol concentrations decreased more with the HP ( 0.30 + /- 0.10 mmol/L ) than with the HC ( 0.10 + /- 0.06 mmol/L ) diet ( P = 0.007 ) . Fasting LDL-cholesterol , HDL-cholesterol , glucose , insulin , free fatty acid , and C-reactive protein concentrations decreased with weight loss . Serum vitamin B-12 increased 9 % with the HP diet and decreased 13 % with the HC diet ( P Folate and vitamin B-6 increased with both diets ; homocysteine did not change significantly . Bone turnover markers increased 8 - 12 % and calcium excretion decreased by 0.8 mmol/d ( P Creatinine clearance decreased from 82 + /- 3.3 to 75 + /- 3.0 mL/min ( P = 0.002 ) . CONCLUSION An energy-restricted , high-protein , low-fat diet provides nutritional and metabolic benefits that are equal to and sometimes greater than those observed with a high-carbohydrate diet",
"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 ",
"Diets with increased protein and reduced carbohydrates ( PRO ) are effective for weight loss , but the long-term effect on maintenance is unknown . This study compared changes in body weight and composition and blood lipids after short-term weight loss ( 4 mo ) followed by weight maintenance ( 8 mo ) using moderate PRO or conventional high-carbohydrate ( CHO ) diets . Participants ( age = 45.4 + /- 1.2 y ; BMI = 32.6 + /- 0.8 kg/m(2 ) ; n = 130 ) were r and omized to 2 energy-restricted diets ( -500 kcal/d or -2093 kJ/d ) : PRO with 1.6 g x kg(-1 ) x d(-1 ) protein and 0.8 g x kg(-1 ) x d(-1 ) protein , > 220 g/d carbohydrates . At 4 mo , the PRO group had lost 22 % more fat mass ( FM ) ( -5.6 + /- 0.4 kg ) than the CHO group ( -4.6 + /- 0.3 kg ) but weight loss did not differ between groups ( -8.2 + /- 0.5 kg vs. -7.0 + /- 0.5 kg ; P = 0.10 ) . At 12 mo , the PRO group had more participants complete the study ( 64 vs. 45 % , P body composition ; however , weight loss did not differ between groups ( -10.4 + /- 1.2 kg vs. -8.4 + /- 0.9 kg ; P = 0.18 ) . Using a compliance criterion of participants attaining > 10 % weight loss , the PRO group had more participants ( 31 vs. 21 % ) lose more weight ( -16.5 + /- 1.5 vs. -12.3 + /- 0.9 kg ; P FM ( -11.7 + /- 1.0 vs. -7.9 + /- 0.7 kg ; P CHO diet reduced serum cholesterol and LDL cholesterol compared with PRO ( P PRO had sustained favorable effects on serum triacylglycerol ( TAG ) , HDL cholesterol ( HDL-C ) , and TAG : HDL-C compared with CHO at 4 and 12 mo ( P FM loss and body composition improvement during initial weight loss and long-term maintenance and produced sustained reductions in TAG and increases in HDL-C compared with the CHO diet",
"Background While high protein diets have been shown to improve satiety and retention of lean body mass ( LBM ) , this study was design ed to determine effects of a protein-enriched meal replacement ( MR ) on weight loss and LBM retention by comparison to an isocaloric carbohydrate-enriched MR within customized diet plans utilizing MR to achieve high protein or st and ard protein intakes . Methods Single blind , placebo-controlled , r and omized outpatient weight loss trial in 100 obese men and women comparing two isocaloric meal plans utilizing a st and ard MR to which was added supplementary protein or carbohydrate powder . MR was used twice daily ( one meal , one snack ) . One additional meal was included in the meal plan design ed to achieve individualized protein intakes of either 1 ) 2.2 g protein/kg of LBM per day [ high protein diet ( HP ) ] or 2 ) 1.1 g protein/kg LBM/day st and ard protein diet ( SP ) . LBM was determined using bioelectrical impedance analysis ( BIA ) . Body weight , body composition , and lipid profiles were measured at baseline and 12 weeks . Results Eighty-five subjects completed the study . Both HP and SP MR were well tolerated , with no adverse effects . There were no differences in weight loss at 12 weeks ( -4.19 ± 0.5 kg for HP group and -3.72 ± 0.7 kg for SP group , p > 0.1 ) . Subjects in the HP group lost significantly more fat weight than the SP group ( HP = -1.65 ± 0.63 kg ; SP = -0.64 ± 0.79 kg , P = 0.05 ) as estimated by BIA . There were no significant differences in lipids nor fasting blood glucose between groups , but within the HP group a significant decrease in cholesterol and LDL cholesterol was noted at 12 weeks . This was not seen in the SP group . Conclusion Higher protein MR within a higher protein diet result ed in similar overall weight loss as the st and ard protein MR plan over 12 weeks . However , there was significantly more fat loss in the HP group but no significant difference in lean body mass . In this trial , subject compliance with both the st and ard and protein-enriched MR strategy for weight loss may have obscured any effect of increased protein on weight loss demonstrated in prior weight loss studies using whole food diets",
"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",
"OBJECTIVE : To test the hypothesis that hyperinsulinemic obese subjects would respond differently to changes in the composition of hypoenergetic diets . DESIGN : A 4-week r and omized dietary intervention trial . SUBJECTS : Thirteen male obese hyperinsulinemic normoglycemic subjects were divided into two groups and fed hypoenergetic diets providing 80 % of their resting energy expenditure ( REE ) . One group received a high-protein diet ( HP ; 45 % protein , 25 % carbohydrates , and 30 % fat as percent of dietary energy ) and the other a high-carbohydrate diet ( HC ; 12 % protein , 58 % carbohydrates and 30 % fat ) . MEASUREMENTS : Anthropometry , body composition , fasting serum insulin and lipids , and REE were performed before and after the feeding period . RESULTS : Weight loss was higher in the HP than HC group ( 8.3±0.7 vs 6.0±0.6 kg , P decrease in body fat in both groups , whereas body water decreased significantly more in the HP group . REE decreased more in the HC than the HP group ( −384.3±84.6 vs −132.3±51.0 kcal , P decreased significantly to a similar extent in both diet groups , while HDL cholesterol was decreased significantly only in the HP group . Mean fasting insulin decreased significantly in both diet groups and reached the normal range only in the HP group . CONCLUSION : A low-carbohydrate ( LC ) , HP hypoenergetic diet could be the diet composition of choice for a weight-reducing regimen in obese hyperinsulinemic subjects",
"We have recently reported that obese women r and omized to a low-carbohydrate diet lost more than twice as much weight as those following a low-fat diet over 6 months . The difference in weight loss was not explained by differences in energy intake because women on the two diets reported similar daily energy consumption . We hypothesized that chronic ingestion of a low-carbohydrate diet increases energy expenditure relative to a low-fat diet and that this accounts for the differential weight loss . To study this question , 50 healthy , moderately obese ( body mass index , 33.2 + /- 0.28 kg/m(2 ) ) women were r and omized to 4 months of an ad libitum low-carbohydrate diet or an energy-restricted , low-fat diet . Resting energy expenditure ( REE ) was measured by indirect calorimetry at baseline , 2 months , and 4 months . Physical activity was estimated by pedometers . The thermic effect of food ( TEF ) in response to low-fat and low-carbohydrate breakfasts was assessed over 5 h in a subset of subjects . Forty women completed the trial . The low-carbohydrate group lost more weight ( 9.79 + /- 0.71 vs. 6.14 + /- 0.91 kg ; P body fat ( 6.20 + /- 0.67 vs. 3.23 + /- 0.67 kg ; P energy intake between the diet groups as reported on 3-d food records at the conclusion of the study ( 1422 + /- 73 vs. 1530 + /- 102 kcal ; 5954 + /- 306 vs. 6406 + /- 427 kJ ) . Mean REE in the two groups was comparable at baseline , decreased with weight loss , and did not differ at 2 or 4 months . The low-fat meal caused a greater 5-h increase in TEF than did the low-carbohydrate meal ( 53 + /- 9 vs. 31 + /- 5 kcal ; 222 + /- 38 vs. 130 + /- 21 kJ ; P = 0.017 ) . Estimates of physical activity were stable in the dieters during the study and did not differ between groups . These results confirm that short-term weight loss is greater in obese women on a low-carbohydrate diet than in those on a low-fat diet even when reported food intake is similar . The differential weight loss is not explained by differences in REE , TEF , or physical activity and likely reflects underreporting of food consumption by the low-fat dieters",
"OBJECTIVE We performed this study as a pilot experiment to investigate the short term effects of two diets of varying composition on weight loss as the primary outcome in obese women with polycystic ovary syndrome ( PCOS ) seeking fertility . DESIGN R and omized clinical trial . SETTING Academic medical center . PATIENT(S ) Thirty-five obese women with PCOS . INTERVENTION(S ) We examined the effects of a 1-month dietary intervention on the PCOS phenotype . Participants were r and omized to one of two energy-restricted diets ; high protein ( HP : 30 % protein , 40 % carbohydrate , and 30 % fat ) or high carbohydrate ( HC : 15 % protein , 55 % carbohydrate , and 30 % fat ) . The fat content was held constant in both diets . MAIN OUTCOME MEASURE(S ) Primary - change in body weight ; Secondary - biometric , hormonal , lipid and lipoprotein , and markers of glucose homeostasis and energy metabolism . RESULT ( S ) Twenty-six women completed the study . Both the HP ( -3.7 + /- 1.9 kg ) and HC ( -4.4 + /- 1.5 kg ) diets result ed in significant weight loss , but there was no significant difference in mean weight loss between the two groups . There were also no differences between diets on a variety of measures including circulating and rogens , measures of glucose metabolism , and leptin . However , the effects of a hypocaloric diet per se on improving metabolic and reproductive abnormalities in a group of PCOS women were marked by a decline in circulating and rogens ( P=.03 ) , fasting and area under the curve ( AUC ) insulins ( P fasting and AUC leptin levels ( P menstrual bleeding during the trial ( 14 out of 26 patients ) . CONCLUSION ( S ) Those who completed the short-term hypocaloric diet had a significant weight loss and a significant improvement in their reproductive and metabolic abnormalities . There was no increased benefit to a high-protein diet . Future diet studies evaluating the ideal composition of a hypocaloric diet in women with PCOS will require a large study population , and will most likely require a multicenter trial",
"Background : The effectiveness of high-protein ( HP ) diets in reducing body weight and adiposity and potentially improving clinical outcomes in heart failure ( HF ) is not known . Objective : This feasibility study was conducted to evaluate the impact of 3 dietary interventions on body weight and adiposity , functional status , lipid profiles , glycemic control , and quality of life ( QOL ) in overweight and obese patients with HF and type 2 diabetes mellitus . Design : Fourteen patients with HF with a body mass index greater than 27 kg/m2 were r and omized to an HP diet , a st and ard protein diet , or a conventional diet . Data were obtained at baseline and 12 weeks . Results : There were no significant differences in age ( 59 ± 10 years ) , sex ( 78 % male ) , New York Heart Association class ( 43 % class II , 57 % class III ) , and HF etiology or left ventricular ejection fraction ( 26 ± 7 ) between the groups at baseline . Patients on the HP diet demonstrated significantly greater reductions in weight ( P = .005 ) , percent body fat ( P = .036 ) , total cholesterol ( P = .016 ) , triglyceride concentrations ( P = .034 ) , and low-density lipoprotein cholesterol ( P = .041 ) and greater improvements in functional status ( 6-minute walk [ P = .010 ] and VO2 peak [ P = .003 ] ) , high-density lipoprotein cholesterol ( P = .006 ) , and physical QOL scores ( P = .022 ) compared with those on st and ard protein and conventional diets . Conclusion : A 12-week HP diet result ed in moderate weight loss and reduced adiposity in a small sample of overweight and obese patients with HF that were associated with improvements in functional status , lipid profiles , glycemic control , and QOL . However , these preliminary findings must be confirmed in studies with more participants and long-term follow-up",
"The short-term effects on plasma lipoprotein lipids of substituting meat and dairy protein for carbohydrate in the diets of 10 free-living moderately hypercholesterolemic human subjects ( four men , six women ) were studied under closely supervised dietary control during the consumption of constant , low intakes of fat and cholesterol and the maintenance of stable body weight as well as constant fiber consumption . Subjects were r and omly allocated to either the high or low protein diets ( mean , 23 % v 11 % of energy as protein , 24 % as fat , and 53 % v 65 % as carbohydrate ) and then switched to the other diet for another 4 to 5 weeks . Mean fasting plasma high-density lipoprotein cholesterol ( HDL-C ) was significantly higher by 12 % + /- 4 % ( 0.97 + /- 0.08 v 0.89 + /- 0.08 mmol/L , P less than .01 ) , whereas mean total cholesterol ( TC ) was lower by 6.5 % + /- 1.3 % ( 5.7 + /- 0.3 v 6.1 + /- 0.3 mmol/L , P less than .001 ) , mean low-density lipoprotein-cholesterol ( LDL-C ) lower by 6.4 % + /- 2.0 % ( 4.5 + /- 0.2 v 4.8 + /- 0.2 mmol/L , P less than .02 ) , mean total triglycerides ( TG ) lower by 23 % + /- 5 % ( 1.7 + /- 0.1 v 2.4 + /- 0.3 mmol/L , P less than .02 ) , and mean high versus low protein diet . Mean values for LDL-C were significantly lower during weeks 3 to 5 of the high protein diet than during either weeks 1 to 5 or weeks 1 to 2 of the high protein diet ( 4.3 + /- 0.3 , 4.5 + /- 0.2 , and 4.7 + /- 0.3 mmol/L , respectively , P less than .05 ) and 11 % + /- 3 % lower than on low protein diet , P less than .005 . The ratio of plasma LDL-C to HDL-C was consistently lower by 17 % + /- 3 % during the high versus low protein diet ( 4.9 + /- 0.5 v 5.8 + /- 0.5 , P less than .001 ) . Lowering plasma TC and LDL-C and total TG and VLDL-TG and increasing HDL-C by chronic isocaloric substitution of dietary for carbohydrate may enhance the cardiovascular risk reduction obtained by restriction of dietary fat and cholesterol",
"BACKGROUND Energy restriction is a common therapeutic approach for weight reduction , but the most effective macronutrient distribution of the hypoenergetic diet as well as the role of the metabolic processes involved require further investigations . OBJECTIVE To study the effect of a high protein ( HP ) hypoenergetic diet compared with a high carbohydrate ( HC ) hypoenergetic diet on fuel utilisation changes during the weight loss process in obese women . DESIGN Eleven obese ( BMI > 30 ) women were r and omly assigned to a 10w dietary intervention study comparing HP ( 30 % protein ) or HC ( 55 % carbohydrate ) energy restricted diets providing 30 % energy fat content . Substrate utilisation was evaluated by indirect calorimetry . Body weight and composition ( Bod Pod ) and blood measurements were performed before and after weight loss . RESULTS On average , the individuals on the HP dietary group lost 4.4 kg more than those in the HC program ( p fat mass loss ( 3.7 kg , p lean body mass reduction . These losses were accompanied by a significant decrease in fasting leptin in the HP group ( -52 % ; P post-absorptive lipid oxidation decreased in the HC group ( -48 % ) and remained unchanged in the HP groups . CONCLUSIONS The replacement of some dietary carbohydrate by protein in energy restricted diets , improves weight and fat losses and specifically promotes lipid oxidation in the fasting state , without major different in lean body mass depletion",
"CONTEXT Incidence of insulin resistance ( IR ) in Americans is steadily rising . IR may be ameliorated with diets on body weight and composition in overweight adults with IR . DESIGN Participants r and omly assigned to a high-protein , low-fat ( HPLF ) or a high-carbohydrate , low-fat ( HCLF ) diet for 8 weeks . SETTING All meals prepared and weighed in the metabolic kitchen at Arizona State University . Lunch consumed on-site ; all other meals packaged for home consumption . PATIENTS Twenty overweight , healthy participants with elevated fasting serum insulin ( > or = 15 microU/L ) were recruited . INTERVENTIONS Both diets were low-fat ( 27 % kcal from fat ; polyunsaturated ) and energy-restricted ( energy levels were 1200 , 1500 , 1700 or 2000 kcal ) ; HPLF : 32 % protein , 41 % carbohydrate ; HCLF : 59 % carbohydrate , 14 % protein . Energy levels were assigned on the basis of participant 's resting metabolic rate . MAIN OUTCOME MEASURES Body composition , etabolic indices , fasting plasma glucose , and insulin . RESULTS No significant differences were found in the main outcome measures between the diets . Body weight ( HPLF : -4.9 kg ; HCLF : -4.0 kg ) and total percent body fat ( HPLF : -1.5 % ; HCLF : -0.4 % ) significantly reduced from baseline to week 8 ( P = .005 and P = .035 , respectively ) . CONCLUSION Both diets promoted > or = 5 % loss in body weight and significantly reduced percent body fat"
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QUESTION What is the effect of exercise on reducing impairment and increasing activity in the rehabilitation of people with upper limb fractures ? DESIGN Systematic review of controlled trials . PARTICIPANTS Adults following an upper limb fracture . INTERVENTION Any exercise therapy program , including trials where exercise was delivered to both groups providing there was an expectation of different amounts of exercise . OUTCOME MEASURES Body structure and function , and activity limitations . RESULTS 13 relevant trials involving 781 participants with an upper limb fracture were identified . 12 of the 13 trials included exercise of different duration and administration in both intervention and comparison groups . In support of the role of exercise there is evidence that : exercise and advice compared to no intervention reduce pain and improve upper limb activity in the short term after distal radius fracture ; starting exercise earlier after conservatively managed proximal humeral fractures can reduce pain and improve shoulder activity ; and physiotherapy that included supervised exercise and home exercise increased wrist movement after distal radius fracture when compared to home exercise alone . There is contrary evidence from two trials one after distal radius fracture and one after proximal humeral fracture that a home exercise program was superior to a supervised plus home exercise program . Only a single meta- analysis was conducted due to clinical heterogeneity and a lack of common outcome measures among the included trials . CONCLUSION There is evidence to support the role of specific exercise regimens in reducing impairments and improving upper limb function following specific upper limb fractures
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"Unilateral Colles ' fractures in 187 patients over the age of 55 years were studied in a r and omised prospect i ve trial : 97 fractures were minimally displaced and were treated either conventionally or in a crêpe b and age ; 90 displaced Colles ' fractures were reduced and of these 47 were treated conventionally while 43 were encouraged to mobilise the wrist in a cast which restricted extension . Early wrist movement hastened functional recovery and led to earlier resolution of wrist swelling . Discomfort was no greater than in patients who were treated conventionally . The bony deformity , which recurred irrespective of the method of treatment , was not adversely affected by early mobilisation",
"The results of a prospect i ve controlled trial of early mobilisation of Colles ' fractures in the elderly are presented . Early mobilisation produced less pain and a stronger grip . It did not lead to any greater loss of reduction of the fracture . However , there was no significant improvement in the final range of movement of the wrist . Immobilisation of the wrist for six weeks in plaster is extremely inconvenient for the elderly living alone and the patients greatly appreciated the reduction of this period of time to a minimum",
"Abstract Colles ’ fracture patients who received physiotherapy immediately following cast removal were compared with patients who received no active therapy following cast removal in a prospect i ve r and omised study . Patients who attended physiotherapy achieved significantly greater increases in wrist extension and grip strength after 6 weeks compared to patients who received no active therapy",
"42 patients with undisplaced , proximal humeral fractures were r and omly assigned into two groups in order to compare the results of instruction to the patient for independent exercises and conventional physiotherapy . No differences appeared between the groups subjectively or as regards functional parameters at 1 as well as at 3 months after the fracture and at a follow up more than 1 year later . As no disadvantage could be found instructions to the patients should in these cases be regarded as a satisfactory after-treatment",
"OBJECTIVE To determine the effect of 2 different postoperative therapy approaches after operative stabilization of the wrist fractures : treatment by a physical therapist with 12 sessions and an unassisted home exercise program . DESIGN R and omized controlled cohort study . SETTING Hospital-based care , primary center of orthopedic surgery . PARTICIPANTS Volunteers ( N=48 ) with fractures of the distal radius after internal fixation with locking plates . There were 46 patients available for follow-up after exclusion of 2 participants due to physiotherapy sessions in excess of the study protocol . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Evaluation of grip strength using a Jamar dynamometer , range of motion ( ROM ) , and Patient Related Wrist Evaluation ( PRWE ) . RESULTS After a 6-week period of postoperative treatment , the patients ( n=23 ) performing an independent home exercise program using a training diary showed a significantly greater improvement of the functionality of the wrist . Grip strength reached 54 % ( P=.003 ) , and ROM in extension and flexion 79 % ( P Ulnar and radial abduction was also higher in this group . In contrast , patients who were treated by a physical therapist achieved grip strength equal to 32 % , and ROM in extension and flexion of 52 % of the uninjured side . Patients who were performing the home training after operation recorded an improved wrist function with a nearly 50 % lower value ( P PRWE score . CONCLUSIONS In the postoperative rehabilitation of wrist fractures , instructions in a home exercise program are an effective alternative to prescribed physical therapy treatment",
"Two methods of physiotherapy after fracture of the proximal end of the humerus were compared . The study was design ed as a r and omized , controlled and single-blind trial . Twenty patients were assigned to two groups 10 - 12 days after the injury . One group was treated conventionally , the other received instructions in self-training with follow-up control of results . Objective examination and subjective assessment were made at five intervals , up to one year after the injury . The greatest improvement in function was shown in both groups between 3 and 8 weeks . The patients deemed their daily life functions to be normal 8 weeks after the injury . The objective assessment was normal at later stages . No significant differences were found between the two groups in any of the tests . Instruction in self-training with control of results including objective assessment s are therefore an adequate method in the rehabilitation of these patients",
"Ninety consecutive women with unilateral Colles ' fractures were r and omized into two different treatment groups . The control group was treated for 5 weeks in conventional short-arm , below the elbow plaster of Paris casts . The other group ( N = 45 ) was treated similarly in plaster casts for 3 weeks and then had flexible casting applied for the remaining 2 weeks which allowed for early joint mobilization . Functional recovery was assessed by measuring grip strength and joint mobility at intervals over the 3 years . Radiographic and overall assessment s were also made during 3 year course of study . Virtually all patients reported greater comfort after switching to the flexible casting . Mean grip scores and joint mobilities were higher at all time points with early mobilization , reaching levels of statistical significance at 6 months for grip score and at 3 months for joint mobility . By 3 years most differences between treatment groups had resolved . We found no evidence that early mobilization was detrimental to recovery . We conclude that early mobilization is a satisfactory treatment option for Colles ' fracture , and may , in fact , hasten functional recovery",
"Forty patients participated in a study of the importance of early occupational therapy for the prognosis in stable Colles ' fractures . Seventeen patients were treated by an occupational therapist 1 - 3 days after the injury , and the need for appliances and home-care was estimated . Twenty-three patients completed the usual treatment . Five weeks after the injury , we found significantly ( p less than 0.05 ) better function of the h and in the 17 patients with early occupational therapy . This difference in function could not be found after 13 weeks . The rate of complications was the same in the two groups . The results indicate that contact with the occupational therapist shortly after the injury is valuable in patients with stable Colles ' fractures",
"BACKGROUND There have been few r and omized controlled trials evaluating nonoperative treatment of proximal humeral fractures . To investigate shortening the period of dependence , we assessed the feasibility and efficacy of early mobilization of the shoulder ( within three days after the fracture ) in comparison with those of conventional three-week immobilization followed by physiotherapy . METHODS We r and omly assigned seventy-four patients with an impacted proximal humeral fracture to receive early passive mobilization or conventional treatment . The primary outcome was the overall shoulder functional status ( as measured with the Constant score ) at three months . The secondary outcomes were the Constant score at six weeks and at six months , the change in pain ( on a visual analog scale ) , and the active and passive range of motion . RESULTS At three months and at six weeks , the early mobilization group had a significantly better Constant score than did the conventional-treatment group ( between-group difference , 9.9 [ 95 % confidence interval , 1.9 to 17.8 ] [ p = 0.02 ] and 10.1 [ 95 % confidence interval , 2.0 to 18.1 ] [ p = 0.02 ] , respectively ) and better active mobility in forward elevation ( between-group difference , 12.0 [ 95 % confidence interval , 1.7 to 22.4 ] [ p = 0.02 ] and 28.1 [ 95 % confidence interval , 7.1 to 49.1 ] [ p = 0.01 ] , respectively ) . At three months , the early mobilization group had significantly reduced pain compared with the conventional-treatment group ( between-group difference , 15.7 [ 95 % confidence interval , 0.52 to 30.8 ] [ p = 0.04 ] ) . No complications in displacement or nonhealing were noted . CONCLUSIONS Early mobilization for impacted nonoperatively treated proximal humeral fractures is safe and is more effective for quickly restoring the physical capability and performance of the injured arm than is conventional immobilization followed by physiotherapy",
"Abstract . In this r and omized trial , we enrolled 30 patients treated for a distal radius Colles ' type fracture . The fractures were reduced if necessary and fixed in a below-elbow plaster cast for 5 weeks . One group consisting of 14 patients received instructions for shoulder ; elbow and finger exercise and the other group consisting of 16 patients had occupational therapy . At 5 weeks , 3 and 9 months we measured the functional scores . There were no statistically significant differences between the groups at any time . It seems that for non-surgically treated patients with a distal radius fracture only instructions are necessary . Résumé . Etude r and omisée de 30 patients traités d'une fracture distale du radius de type Pouteaux-Colles . Les fractures furent réduites si nécessaire et fixées dans une manchette plâtrée durant 5 semaines . L'un des groupes était constitué de 14 patients qui avaient reçu des instructions d'exercices pour l'épaule , le coude et les doigts . L'autre groupe était constitué de 16 patients qui ont bénéficié d'une ergothérapie . Une évaluation a été faite après 5 semaines , 3 et 9 mois . Il n'avait aucune différence significative entre les 2 groupes en aucune période . Il semble ainsi suffisant , dans les fractures distales du radius traitées orthopédiquement , d'instruire les patients en vue d'une autoréeducation",
"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 .",
"The Study of Osteoporotic Fractures is a prospect i ve cohort study begun in 1986 that includes 9,704 women aged 65 years and older from Maryl and , Minnesota , Oregon , and Pennsylvania . A total of 171 women suffered fractures of the distal forearm , and 79 women had fractures of the proximal humerus during the first 2.2 years of follow-up . Most fractures at both sites occurred as a result of a fall . Low bone mineral density was a strong predictor of these fractures ; comparing those in the lowest quintile of bone mineral density in the distal radius with those in the highest quintile , the rate ratio was 4.1 for fractures of the distal forearm and 7.5 for fractures of the proximal humerus . Other factors associated with an increased rate of distal forearm fracture independently of low bone mineral density included poor visual acuity , number of falls in the year before baseline , and frequent walking . Factors that appeared to be independently associated with an increased rate of fracture of the proximal humerus included a recent decline in health status , insulin-dependent diabetes mellitus , infrequent walking , and several indicators of neuromuscular weakness such as inability to st and with feet in a t and em position for more than a few seconds . These data support the hypothesis that distal forearm fractures often occur as a result of a fall in women with low bone mineral density who are relatively healthy and active and have good neuromuscular function , while fractures of the proximal humerus tend to occur as a result of a fall in women with low bone mineral density who are less healthy and less active than average and who have poor neuromuscular function",
"The capacity for physiotherapy to improve the outcome after fracture of the distal radius is unproven . We carried out a r and omised controlled trial on 96 patients , comparing conventional physiotherapy with a regime of home exercises . The function of the upper limb was assessed at the time of removal of the plaster cast and at three and six months after injury . Factors which may predict poor outcome in these patients were sought . Grip strength and h and function did not significantly differ between the two groups . Flexion and extension of the wrist were the only movements to improve with physiotherapy at six months ( p = 0.001 ) . Predictors of poor functional outcome were malunion and impaired function before the fracture . These patients presented with pain , decreased rotation of the forearm and low functional scores at six weeks . Our study has shown that home exercises are adequate rehabilitation after uncomplicated fracture of the distal radius , and routine referral for a course of physiotherapy should be discouraged . The role of physiotherapy in patients at high risk of a poor outcome requires further investigation",
"The 2-year results of a r and omized , prospect i ve , controlled trial of minimally displaced proximal humeral fractures treated either by immediate physiotherapy ( group A ) or after 3 weeks of immobilization ( group B ) are reported . At 1 year shoulder disability , as measured with the Croft shoulder disability question naire , was found in 42.8 % of patients in group A and 72.5 % in group B ( P shoulder disability in group A remained unchanged ( 43.2 % ) but had reduced in group B ( 59.5 % ) . This difference was not statistically significant . Immediate physiotherapy after a minimally displaced proximal humeral fracture results in faster recovery , with maximal functional benefit being achieved at 1 year . Delayed rehabilitation by 3 weeks of shoulder immobilization produces a slower recovery , which continues for at least 2 years after the time of injury",
"QUESTION Does an advice and exercise program improve outcome for adults following distal radius fracture ? DESIGN R and omised trial with concealed allocation , assessor blinding , and intention-to-treat analysis . PARTICIPANTS Fifty-six patients whose fracture had been managed with pins and /or cast . INTERVENTION The experimental group received a physiotherapist-directed program of advice and exercises . The control group did not receive any physiotherapy intervention . OUTCOME MEASURES The primary outcome was wrist extension ( measured with a goniometer ) . Secondary outcomes were the other wrist ranges of motion ( measured with a goniometer ) , grip strength ( measured with a dynamometer ) , pain , and activity limitations ( measured with question naires ) . These outcomes were measured initially , then three and six weeks later . Participants also rated their satisfaction with physiotherapy intervention at Week 6 . RESULTS No difference was found between groups for the primary outcome of wrist extension ( mean difference 6 deg , 95 % CI -3 to 14 ) , nor for the secondary outcomes of other range of motion data and grip strength . The difference between groups for pain was -16 points out of 100 ( 95 % CI -27 to -5 ) at Week 3 , and -14 points ( 95 % CI -25 to -3 ) points at Week 6 , and for activity was -13 points out of 100 ( 95 % CI -24 to -2 ) at Week 3 ; in favour of the experimental group . The experimental group was also more satisfied with the amount of physiotherapy intervention . CONCLUSION An advice and exercise program provided some additional benefits over no intervention for adults following distal radius fracture",
"We compared two protocol s of early mobilisation for minimally displaced radial head fractures through a single-blinded , prospect i ve r and omised trial . Sixty patients were r and omly allocated to either immediate active mobilisation or 5-day delay before active mobilisation was commenced . Patients were review ed at 7 days , 4 weeks and 3 months after injuries . A blinded observer assessed each patient . All fractures united by the third month . At the end of 7 days , the mobilisation group had less pain ( visual analogue scale ( VAS ) 6 versus 7.6 , P=0.002 ) ; greater flexion ( mean 112 versus 98 degrees , P=0.0004 ) ; greater strength in supination ( P better elbow function ( Morrey Score : 54 versus 43 , P=0.005 ) . By the fourth week , both groups were comparable in all parameters and improvement continued into the third month . Mean limit of extension at the third month were 2.3 degrees in the immediate mobilisation group and 1.8 degrees in the delayed group ( NS ) . All had excellent function on the basis of the Morrey Score . Immediate mobilisation did not adversely affect the outcome ; the patients had less pain and better elbow function at 1-week post-injury . Pain , ranges of movement and function were similar by the fourth week post-injury",
"Introduction : Physiotherapy is considered by some authorities to be an important aspect of management in patients following distal radius fractures . There is evidence of improvement in impairment with physiotherapy ; however , there is no evidence to support early return of functional activity . Traditional physiotherapy management has focussed on improving impairment ; however , there are no trials with emphasis on skill acquisition via motor re-learning principles . Material s and methods : Forty-one participants with conservatively managed distal radius fractures were studied in a r and omised , single-blinded , prospect i ve trial . Two treatment options were compared : exercise and advice versus activity-focussed physiotherapy with measurement periods of 6 weeks after removal of cast and follow-up at 24 weeks . Results : Participants allocated to the exercise and advice group consulted a physiotherapist an average of 0.9 ( SD 0.4 ) times , while the participants allocated to the more intensive activity-focussed group consulted with physiotherapy a mean of 4.4 ( SD 2.3 ) times . At both 6 and 24 weeks there were no significant differences between the groups for change in impairment ( as measured by grip strength , range of motion of wrist flexion and extension and pain intensity ) , activity limitation and participation restriction , as measured by the Patient-Rated Wrist Evaluation ( PRWE ) . Exercise and advice given by a physiotherapist were equally as effective as activity-focussed physiotherapy in recovery both at 6 and 24 weeks . Conclusion : The results suggest that after removal of cast from fracture of distal radius , patients may routinely require no more than a single session of advice and exercise provided by a physiotherapist",
"This is a prospect i ve follow up of 190 consecutive cases of volar plate avulsion fractures . A st and ard management regimen of immediate , active movement was followed in all cases and physiotherapy was rarely required . Of the 190 patients , 162 were followed up for at least one year . An excellent or good outcome was achieved in 98 per cent . Patients presenting more than three weeks from injury had a worse outcome . The size and displacement of the avulsed fragment did not affect the outcome . For the stable joint , early active mobilisation with minimal or no splintage provides a good result",
"This r and omized controlled trial compares 2 mobilization regimens after shoulder hemiarthroplasty for acute 3- and 4-part fractures . The aim was to establish whether the length of immobilization plays a role in the functional outcome , tuberosity healing , and subsequent range of motion . The same prosthesis and surgical technique were used . We recruited 59 patients into the study ; 31 were r and omized to early ( 2 weeks ) mobilization and 28 to late ( 6 weeks ) mobilization . Greater tuberosity migration was assessed with a series of radiographs , and the functional outcome was assessed with the Constant Shoulder Assessment and Oxford shoulder scores . Of the patients , 49 ( mean age , 70 years ) met the inclusion criteria and were followed up for 12 months . Greater tuberosity migration occurred in 3 cases in the early mobilization group and once in the late mobilization group ( P > .10 ) . There was no significant difference in the Constant Shoulder Assessment and Oxford scores between the 2 groups . Although there was a decreased incidence of tuberosity migration in the group undergoing late mobilization , this was not statistically significant",
"We undertook a prospect i ve , controlled trial which compared two rehabilitation programmes for 86 patients who sustained two-part fractures of the proximal humerus . Patients were r and omised either to receive immediate physiotherapy within one week ( group A ) or delayed physiotherapy after three weeks of immobilisation in a collar and cuff sling ( group B ) . At 16 weeks after the fracture , patients in group A had less pain ( p greater shoulder function ( p shoulder function and less pain , there was no statistical difference when compared with group B. By analysis of the area under the curve , an overall measure up to the 52-week period , group A experienced less pain as measured by the SF36 general health question naire and had improved shoulder function . Our results show that patients with two-part fractures of the proximal humerus who begin immediate physiotherapy , experience less pain . The gains in shoulder function persist at 52 weeks which suggests that patients do not benefit from immobilisation before beginning physiotherapy",
"We present a 5-year prospect i ve study of the epidemiology of 1,027 proximal humeral fractures . These fractures , which tend to occur in fit elderly persons , have a unipolar age distribution and the highest age-specific incidence occurs in women between 80 and 89 years of age . The commonest was the B1.1 impacted valgus fracture , found in one-fifth of the cases in this series , a type that is not included in the Neer classification . We used both Neer and AO classifications . The AO classification proved to be more comprehensive because in the Neer classification , half of the fractures are minimally displaced and almost nine-tenths fall into only three categories . In the AO classification , the B1.1 , A2.2 , A3.2 and A1.2 sub-groups comprise over half of all proximal humeral fractures , while the AO type C fractures occur in only 6 % . We suggest that the literature does not adequately reflect the spectrum of proximal humeral fractures"
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Background Atrial fibrillation ( AF ) , a common arrhythmia contributing substantially to cardiac morbidity , is associated with oxidative stress and , being an antioxidant , vitamin C might influence it . Methods We search ed the Cochrane CENTRAL Register , MEDLINE , and Scopus data bases for r and omised trials on vitamin C that measured AF as an outcome in high risk patients . The two authors independently assessed the trials for inclusion , assessed the risk of bias , and extracted data . We pooled selected trials using the Mantel-Haenszel method for the risk ratio ( RR ) and the inverse variance weighting for the effects on continuous outcomes . Results We identified 15 trials about preventing AF in high-risk patients , with 2050 subjects . Fourteen trials examined post-operative AF ( POAF ) in cardiac surgery patients and one examined the recurrence of AF in cardioversion patients . Five trials were carried out in the USA , five in Iran , three in Greece , one in Slovenia and one in Russia . There was significant heterogeneity in the effect of vitamin C in preventing AF . In 5 trials carried out in the USA , vitamin C did not prevent POAF with RR = 1.04 ( 95 % CI : 0.86–1.27 ) . In nine POAF trials conducted outside of the USA , vitamin C decreased its incidence with RR = 0.56 ( 95 % CI : 0.47–0.67 ) . In the single cardioversion trial carried out in Greece , vitamin C decreased the risk of AF recurrence by RR = 0.13 ( 95 % CI : 0.02–0.92).In the non-US cardiac surgery trials , vitamin C decreased the length of hospital stay by 12.6 % ( 95 % CI 8.4–16.8 % ) and intensive care unit ( ICU ) stay by 8.0 % ( 95 % CI 3.0–13.0 % ) . The US trials found no effect on hospital stay and ICU stay . No adverse effects from vitamin C were reported in the 15 trials . Conclusions Our meta- analysis indicates that vitamin C may prevent post-operative atrial fibrillation in some countries outside of the USA , and it may also shorten the duration of hospital stay and ICU stay of cardiac surgery patients . Vitamin C is an essential nutrient that is safe and inexpensive . Further research is needed to determine the optimal dosage protocol and to identify the patient groups that benefit the most
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"The whole-body inflammatory response produced by cardiopulmonary bypass is an important cause of perioperative morbidity after cardiac operations . This inflammatory response produces reactive oxygen species and other cytotoxic substances , such as the cytokines . The generation of reactive oxygen species might deplete principal antioxidant micronutrients , that is , vitamins C and E and the carotenoids . Therefore , we have investigated the time course of the plasma concentrations of vitamins C and E and the carotenoids in 18 patients undergoing coronary bypass operations after r and omization for previous vitamin E supplementation ( 300 mg dl-alpha-acetyl-tocopherol 3 times daily for 4 weeks ) or placebo . Supplementation with alpha-tocopherol doubled the lipid-st and ardized plasma vitamin E concentration to 63.7 + /- 14.5 mumol/L when compared with that of the control subjects ( 31.2 + /- 9.0 mumol/L ) before the operation . The plasma concentrations of vitamin C ( 36.0 + /- 19.0 mumol/L and 44.0 + /- 21.7 mumol/L , respectively ) and of the carotenoids were not statistically different between the two groups at baseline . The absolute plasma concentrations of both vitamin E and the carotenoids decreased during and after cardiopulmonary bypass , but after correction for hemodilution the plasma concentrations of vitamin E and the carotenoids showed no decrease . The vitamin E concentrations in the erythrocytes did not change either . In contrast , the plasma concentration of vitamin C decreased in all subjects within 24 hours after the operation by roughly 70 % . Correction for hemodilution still revealed a significant decrease in plasma vitamin C that persisted in most patients up to 2 weeks . In conclusion , the vitamin E and the carotenoid plasma concentrations are of no major concern during and after cardiac operations . In contrast , the serious depletion of vitamin C may deteriorate the defense against reactive oxygen species-induced injury during cardiac operations",
"OBJECTIVES Our goal was to explore whether antioxidant vitamin C infusion is able to affect the microcirculation perfusion in patients undergoing elective percutaneous coronary intervention for stable angina . BACKGROUND Periprocedural myocardial injury in the setting of elective percutaneous coronary intervention is associated with increased risk of death , recurrent infa rct ion , and revascularization at follow-up . Despite excellent epicardial blood flow , impaired microcirculatory reperfusion may persist and increases the risk of vascular recurrences . Post-percutaneous coronary intervention induced-oxidative stress is one of the potential mechanisms accounting for impaired perfusion . METHODS Fifty-six patients were enrolled in a prospect i ve , single-center , r and omized study comparing 1 g vitamin C infusion ( 16.6 mg/min , over 1 h before percutaneous coronary intervention ) versus placebo . RESULTS At the baseline , Thrombolysis In Myocardial Infa rct ion ( TIMI ) myocardial perfusion grade 2 was observed in 89 % and in 86 % of patients r and omized to the placebo or vitamin C infusion group , respectively ( p > 0.05 ) . After percutaneous coronary intervention , these percentages decreased in the placebo group ( 32 % ) and in greater measure in the vitamin C group ( 4 % , p Complete microcirculatory reperfusion ( TIMI myocardial perfusion grade = 3 ) was achieved in 79 % of the vitamin C-treated group compared with 39 % of the placebo group ( p 8-hydroxy-2-deoxyguanosine ( p 8-iso-prostagl and in F(2alpha ) ( p plasma levels significantly increased in the placebo group while they were significantly reduced in the vitamin C-treated group ( p TIMI myocardial perfusion grade changes from the baseline showed significant correlation with 8-hydroxy-2-deoxyguanosine ( p 8-iso-prostagl and in F(2alpha ) ( p 0.01 ) plasma levels changes . CONCLUSIONS In patients undergoing elective percutaneous coronary intervention , impaired microcirculatory reperfusion is improved by vitamin C infusion suggesting that oxidative stress is implicated in such a phenomenon",
"BACKGROUND Atrial fibrillation occurs after approximately 25 % to 45 % of coronary artery bypass graft ( CABG ) surgeries . Oxidative stress and related electrophysiological remodeling has been proposed as a potential cause of this atrial fibrillation . Perioperative supplementation of the antioxidant ascorbic acid has been evaluated as a preventive agent . The current investigation was conducted to evaluate the efficacy of ascorbic acid in reducing atrial fibrillation in CABG patients . METHODS A prospect i ve , r and omized , placebo-controlled , triple-blind , single-institution study was conducted in nonemergency CABG patients . Subjects were monitored for episodes of arrhythmia and other complications . RESULTS Eighty-nine treatment and 96 control subjects completed the study protocol . Demographics , comorbidities , and preoperative drugs were similar between groups . Surgical characteristics and postoperative medication use also were similar . The incidence of atrial fibrillation was 30.3 % in the treatment group and 30.2 % in the control group ( P = .985 ) . No difference was found in postoperative complications or mortality . CONCLUSIONS Our data indicate that supplementation of ascorbic acid in addition to routine postoperative care does not reduce atrial fibrillation after coronary artery bypass grafting",
"Background : Prolonged intensive care unit ( ICU ) and hospital stay after cardiac surgery is vitally important and is influenced by both intraoperative and postoperative factors . Objectives : This r and omized clinical trial study was design ed to assess whether vitamin C supplementation could reduce the length of ICU and hospital stay in post-cardiac surgery patients . Patients and Methods : Two hundred and ninety patients scheduled for adult cardiac surgery including coronary , valve and congenital operations were r and omized into two groups : an intervention group , who received 2 g of vitamin C ( ascorbic acid ) intravenously , immediately before surgery in the operating theatre , followed by 1 g daily oral doses for the first 4 postoperative days ; and a placebo group , who received an equal number of identical tablets in the same shape and size . Results : Hospital length of stay was significantly different between the two groups ( 10.17 ± 4.63 days in the intervention group vs. 12 ± 4.51 days in the placebo group ; P = 0.01 ) , while there was no significant difference in the ICU stay between the groups ( 3.42 ± 1.06 days in intervention group vs. 3.43 ± 1.09 days in the placebo group ; P = 0.88 ) . There were significant differences in the intubation time and the drainage volume in the ICU and the first 24 postoperative hours between the two groups ( P for both = 0.003 ) . Conclusions : Vitamin C can decrease the length of hospital stay , drainage volume in the ICU and in the first 24 postoperative hours , intubation time and some complications in patients after cardiac surgery ; perhaps by decreasing inflammatory factors",
"BACKGROUND Some evidence s have shown the role of antioxidant vitamins in preventing atrial fibrillation ( AF ) after coronary artery bypass grafting ( CABG ) surgery . We sought to determine the effect of oral vitamin C on the incidence of postoperative AF in patients undergoing elective isolated on-pump CABG surgery . METHODS One-hundred patients who underwent isolated CABG surgery were prospect ively assigned into two groups : Group 1 - 50 patients received 2 g of oral vitamin C before and 500 mg twice daily lasting for 5 days after surgery ; Group 2 - 50 patients as the control group did not receive any . All patients were continuously monitored after surgery in the intensive careunit ( ICU ) , and then Holter monitoring was implemented for 72 h. RESULTS The mean of patients ' age was 61.31 ± 6.42 years . Postoperative AF occurred in 16 and 4 patients in control and treatment groups , respectively ( 32 % vs. 8 % , p = 0.003 ) . The ICU stay was 1.79 ± 0.313 and 2.10 ± 0.61 days for vitamin C and control groups , respectively ( p = 0.002 ) . The hospital stay was significantly lower in vitamin C group compared with that of the control group ( 5.32 ± 0.59 vs. 5.74 ± 1.30 days , respectively , p = 0.041 ) . Baseline erythrocyte sedimentation rate ( OR 1.030 , 95 % CI 1.003 - 1.058 , p = 0.030 ) and taking vitamin C ( OR 8.068 , 95 % CI 1.783 - 36.517 , p = 0.007 ) were the independent predictors of postoperative AF . CONCLUSIONS Oral vitamin C can be safely used to decrease the incidence of postoperative AF in patients undergoing elective isolated on-pump CABG surgery",
"HYPOTHESIS High-dose ascorbic acid ( vitamin C ) therapy ( 66 mg/kg per hour ) attenuates postburn lipid peroxidation , resuscitation fluid volume requirements , and edema generation in severely burned patients . STUDY DESIGN AND SETTING A prospect i ve , r and omized study at a university trauma and critical care center in Japan . SUBJECTS AND METHODS Thirty-seven patients with burns over more than 30 % of their total body surface area ( TBSA ) hospitalized within 2 hours after injury were r and omly divided into ascorbic acid and control groups . Fluid resuscitation was performed using Ringer lactate solution to maintain stable hemodynamic measurements and adequate urine output ( 0.5 - 1.0 ml/kg per hour ) . In the ascorbic acid group ( n = 19 ; mean burn size , 63 % + /- 26 % TBSA ; mean burn index , 57 + /- 26 ; inhalation injury , 15/ 19 ) , ascorbic acid was infused during the initial 24-hour study period . In the control group ( n = 18 ; mean burn size , 53 % + /- 17 % TBSA ; mean burn index , 47 + /- 13 ; inhalation injury , 12/18 ) , no ascorbic acid was infused . We compared hemodynamic and respiratory measurements , lipid peroxidation , and fluid balance for 96 hours after injury . Two-way analysis of variance and Tukey test were used to analyze the data . RESULTS Heart rate , mean arterial pressure , central venous pressure , arterial pH , base deficit , and urine outputs were equivalent in both groups . The 24-hour total fluid infusion volumes in the control and ascorbic acid groups were 5.5 + /- 3.1 and 3.0 + /- 1.7 mL/kg per percentage of burn area , respectively ( P acid group gained 9.2 % + /- 8.2 % of pretreatment weight ; controls , 17.8 % + /- 6.9 % . Burned tissue water content was 6.1 + /- 1.8 vs 2.6 + /- 1.7 mL/g of dry weight in the control and ascorbic acid groups , respectively ( P Fluid retention in the second 24 hours was also significantly reduced in the ascorbic acid group . In the control group , the ratio of PaO2 to fraction of inspired oxygen at 18 , 24 , 36 , 48 , and 72 hours after injury was less than that of the ascorbic acid group ( P length of mechanical ventilation in the control and ascorbic acid groups was 21.3 + /- 15.6 and 12.1 + /- 8.8 days , respectively ( P Serum malondialdehyde levels were lower in the ascorbic acid group at 18 , 24 , and 36 hours after injury ( P ascorbic acid during the first 24 hours after thermal injury significantly reduces resuscitation fluid volume requirements , body weight gain , and wound edema . A reduction in the severity of respiratory dysfunction was also apparent in these patients",
"Atrial fibrillation ( AF ) , the most common chronic arrhythmia , increases the risk of stroke and is an independent predictor of mortality . Available pharmacological treatments have limited efficacy . Once initiated , AF tends to self-perpetuate , owing in part to electrophysiological remodeling in the atria ; however , the fundamental mechanisms underlying this process are still unclear . We have recently demonstrated that chronic human AF is associated with increased atrial oxidative stress and peroxynitrite formation ; we have now tested the hypothesis that these events participate in both pacing-induced atrial electrophysiological remodeling and in the occurrence of AF following cardiac surgery . In chronically instrumented dogs , we found that rapid ( 400 min−1 ) atrial pacing was associated with attenuation of the atrial effective refractory period ( ERP ) . Treatment with ascorbate , an antioxidant and peroxynitrite decomposition catalyst , did not directly modify the ERP , but attenuated the pacing-induced atrial ERP shortening following 24 to 48 hours of pacing . Biochemical studies revealed that pacing was associated with decreased tissue ascorbate levels and increased protein nitration ( a biomarker of peroxynitrite formation ) . Oral ascorbate supplementation attenuated both of these changes . To evaluate the clinical significance of these observations , supplemental ascorbate was given to 43 patients before , and for 5 days following , cardiac bypass graft surgery . Patients receiving ascorbate had a 16.3 % incidence of postoperative AF , compared with 34.9 % in control subjects . In combination , these studies suggest that oxidative stress underlies early atrial electrophysiological remodeling and offer novel insight into the etiology and potential treatment of an enigmatic and difficult to control arrhythmia . The full text of this article is available at http://www.circresaha.org",
"Context Clinical studies of vitamin C as a potential anticancer agent have produced inconsistent results despite in vitro evidence that high concentrations kill cancer cells . Contribution Pharmacokinetic studies in healthy persons , using a depletion-repletion design , show that intravenous administration can achieve 70-fold higher blood levels of vitamin C than the highest tolerated oral dose . Caution s Although this study provides better underst and ing of the pharmacokinetic issues involved in research on vitamin C , it provides no evidence that vitamin C has any effect on cancer cells and can not be used to support its clinical use for therapeutic purpose s. The Editors Vitamin C in gram doses is taken orally by many people and administered intravenously by complementary and alternative medicine practitioners to treat patients with advanced cancer ( 1 , 2 ) . After oral intake , vitamin C plasma concentrations are tightly controlled at 70 to 85 mol/L for amounts ( as much as 300 mg daily ) that can be obtained from food ( 3 , 4 ) . However , concentrations achieved by higher pharmacologic doses are uncertain . Despite poor rationale , vitamin C in gram doses was proposed as an anticancer agent decades ago ( 5 ) . Unblinded studies with retrospective or nonr and om controls reported clinical benefit from oral and intravenous vitamin C administered to patients with terminal cancer at a dosage of 10 g daily ( 1 , 6 , 7 ) . Placebo-controlled trials in patients with cancer reported no benefit from oral vitamin C at a dosage of 10 g daily ( 8 , 9 ) , and vitamin C treatment was judged ineffective ( 10 ) . However , in vitro evidence showed that vitamin C killed cancer cells at extracellular concentrations higher than 1000 mol/L ( 11 , 12 ) , and its clinical use by some practitioners continues . We recognized that oral or intravenous routes could produce substantially different vitamin C concentrations ( 13 ) . We report here that intravenous doses can produce plasma concentrations 30- to 70-fold higher than the maximum tolerated oral doses . These data suggest that the role of vitamin C in cancer treatment should be reexamined , and insights from vitamin C pharmacokinetics can guide its clinical use . Methods Pharmacokinetic Studies in Healthy Persons The study was approved by the Institutional Review Board of the National Institute of Diabetes and Digestive and Kidney Diseases , National Institutes of Health . After we obtained written informed consent , 17 healthy volunteers ( 7 men , 10 women ; age , 19 to 27 years ) were studied as in patients by using a depletion-repletion study design ( 3 , 4 ) . Participants were hospitalized for 3 to 6 months and consumed a vitamin C-deficient diet containing less than 0.005 g of vitamin C per day . At plasma vitamin C concentrations less than 8 mol/L , persons were depleted without signs of scurvy . Vitamin C , 0.015 g twice daily , was then administered orally until participants achieved a steady state for this dose ( 0.03 g daily ) . Participants received successive oral daily vitamin C doses of 0.03 g , 0.06 g , 0.1 g , 0.2 g , 0.4 g , 1.0 g , and 2.5 g until a steady state was achieved for each dose . Bioavailability sampling was conducted at a steady state for vitamin C doses of 0.015 g , 0.03 g , 0.05 g , 0.1 g , 0.2 g , 0.5 g , and 1.25 g. For each bioavailability sampling , vitamin C was administered in the fasting state . After oral administration , blood sample s were collected at 0 , 15 , and 30 minutes and at 1 , 1.5 , 2 , 2.5 , 3 , 3.5 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 19 , 22 , and 24 hours ( 3 , 4 ) . After intravenous administration at 250 mg/min , blood sample s were collected at 0 , 2.5 , 5 , 10 , 15 , and 30 minutes and at 1 , 1.5 , 2 , 2.5 , 3 , 3.5 , 4 , 5 , 6 , 7 , 8 , 9 , and 10 hours . Data obtained from bioavailability samplings were used to determine peak plasma and urine vitamin C concentrations . Pharmacokinetic Modeling We used data from 7 men to construct a unique 3-compartment vitamin C pharmacokinetic model with parameters describing saturable absorption , tissue distribution , and renal excretion and reabsorption ( 14 ) . This model was used to predict peak plasma and urine vitamin C concentrations attained when pharmacologic doses of the vitamin are administered . For intravenous administration , it was assumed that vitamin C was infused at a rate of 1 g/min , and urine output was 100 mL/h . Vitamin C Assay Vitamin C was measured by using high-performance liquid chromatography with coulometric electrochemical detection ( 3 , 4 , 15 ) . Statistical Analysis We compared plasma vitamin C concentration curves ( against either dose or time ) by repeated- measures analyses of variance ( ANOVA ) . In addition to the repeating factor ( dose or time ) , other factors considered were sex and route of administration . In the comparison of routes of administration at multiple doses , in which sex not only was an important factor itself but also had an important interaction with route , separate ANOVA were determined for men and women to assess the importance of route of administration . Analyses were performed by using Data Desk , version 5 ( 1995 ) ( Data Description , Inc. , Ithaca , New York ) . Role of the Funding Source The funding source 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 When 1.25 g of vitamin C was given intravenously , plasma concentrations were significantly higher than when the vitamin was given orally ( P plasma concentrations were significantly higher over all doses ( P peak values from intravenous administration were 6.6-fold higher than mean peak values from oral administration . When all doses were considered , peak plasma vitamin C concentrations increased with increasing intravenous doses , whereas peak plasma vitamin C concentrations seemed to plateau with increasing oral doses . Urine vitamin C concentrations were higher for the same dose given intravenously compared with that administered by the oral route . At the highest dose of 1.25 g , peak urine concentrations from intravenous administration were approximately 3.5 times higher than from oral administration ( data not shown ) . Figure 1 . Plasma vitamin C concentrations in healthy volunteers after intravenous or oral administration of vitamin C. Inset : The 3-compartment vitamin C pharmacokinetic model that we developed predicted that a single oral dose of 3 g , the maximum tolerated single dose , produced a peak plasma concentration of 206 mol/L ( Figure 2 , top ) . Peak predicted concentration after a single 1.25-g oral dose was slightly lower at 187 mol/L. For 200 mg , an amount obtained from vitamin C-rich foods , peak predicted concentration was approximately 90 mol/L. Plasma concentrations for all of these amounts returned to steady-state values , approximately 70 to 85 mol/L , after 24 hours . With 3 g given orally every 4 hours , the maximum tolerable ( 6 ) , peak predicted plasma concentration was approximately 220 mol/L ( Figure 2 , top ) . By contrast , after intravenous administration , predicted peak plasma vitamin C concentrations were approximately 1760 mol/L for 3 g , 2870 mol/L for 5 g , 5580 mol/L for 10 g , 13 350 mol/L for 50 g , and 15 380 mol/L for 100 g ( Figure 2 , bottom ) . Doses of 60 g given intravenously are used for cancer treatment by complementary and alternative medicine practitioners ( 2 ) . Predicted peak urine vitamin C concentrations were as much as 140-fold higher after intravenous administration compared with oral administration ( data not shown ) . Figure 2 . Predicted plasma vitamin C concentrations in healthy persons after oral ( top ) or intravenous ( IV ) ( bottom ) administration of vitamin C. Discussion Our data show that vitamin C plasma concentrations are tightly controlled when the vitamin is taken orally , even at the highest tolerated amounts . By contrast , intravenous administration bypasses tight control and results in concentrations as much as 70-fold higher than those achieved by maximum oral consumption . Both findings have clinical relevance . Vitamin C oral supplements are among the most popular sold , and gram doses are promoted for preventing and treating the common cold , managing stress , and enhancing well-being ( 1 ) . Our data show that single supplement gram doses produce transient peak plasma concentrations that at most are 2- to 3-fold higher than those from vitamin C-rich foods ( 200 to 300 mg daily ) . In either case , plasma values return to similar steady-state concentrations in 24 hours . Because differences in plasma concentrations from supplements and from food intake are not large , supplements would be expected to confer little additional benefit , a finding supported by available evidence ( 16 , 17 ) . However , consumption of fruits and vegetables , which contain vitamin C , is beneficial for unknown reasons ( 16 , 17 ) . On the basis of current knowledge and the pharmacokinetics presented here , physicians should advise their patients to consume fruits and vegetables , not vitamin C supplements , to obtain potential benefits . Just as important , our data show that intravenous administration of vitamin C produces substantially higher plasma concentrations than can be achieved with oral administration of vitamin C. This difference was previously unrecognized and may have treatment implication s. Case series published by Cameron , Campbell , and Pauling ( l , 6 , 7 ) have been controversial . In these series , several hundred patients with terminal cancer treated with 10 g of vitamin C intravenously for 10 days and then 10 g orally indefinitely were compared with more than 1000 retrospective and prospect i ve controls . Patients treated with vitamin C survived 150 to 300 days longer than controls ( 1 , 6 , 7 ) . Other research ers reported benefit consisting of increased survival , improved well-being , and reduced pain ( 1 ) . All of these",
"Atrial fibrillation ( AF ) is a common arrhythmia that occurs postoperatively in cardiac surgery . There is evidence for the role of oxidative stress in the etiology of AF . In our study , we examined whether antioxidant ascorbic acid ( vitamin C ) , could help in the reduction of the incidence of postoperative AF . Patients who were scheduled to undergo elective isolated on-pump coronary artery bypass grafting ( CABG ) were included in our study . One hundred and seventy patients were r and omly divided in two groups : Group A ( n=85 ) received vitamin C preoperatively and postoperatively whereas Group B ( n=85 ) did not receive any ( control group ) . The incidence of AF was 44.7 % in the vitamin C group and 61.2 % in the control group ( P=0.041 ) . The hospitalization time , the intensive care unit stay and the time interval for the conversion of AF into sinus rhythm was significantly shorter in the vitamin C group . Patients that developed AF also had longer hospital length of stay ( 9.5±2.8 days vs. 6.7±1.9 , P=0.034 ) . Supplementation of vitamin C reduces the incidence of postCABG AF , and decreases the time needed for rhythm restoration and length of hospital stay",
"PURPOSE Atrial fibrillation ( AF ) is the most frequent arrhythmia that follows coronary artery bypass graft ( CABG ) . Patients developing postoperative AF ( POAF ) have significantly higher mortality rates . The consistent prophylactic effectiveness of statins and vitamin C are well-accepted ; however , no evaluation on combined therapy has been performed . We aim ed at assessing the efficacy of combination therapy with statin and vitamin C in comparison with statin alone in the prevention of post CABG-AF . METHODS In a r and omized double blind clinical trial , 120 c and i date s of CABG were recruited in Tabriz Madani Educational Center in a 15-month period of time . Patients were r and omized into two groups of 60 receiving oral atorvastatin ( 40 mg ) plus oral vitamin C ( 2g/d operation day and 1g/d for five consequent days ) for intervention group and oral atorvastatin ( 40 mg ) for control group . Occurrence of post CABG AF was compared between the two groups . RESULTS There were 60 patients , 43 males and 17 females with a mean age of 61.0±11.5 ( 29 - 78 ) years , in the intervention group and sixty patients , 39 males and 21 females with a mean age of 60.5±11.3 ( 39 - 81 ) years , in the control group . The post CABG AF occurred in 6 cases ( 10 % ) in the interventional group and 15 patients ( 25 % ) in the controls ( P=0.03 , odds ratio=0.33 , 95 % confidence interval 0.12 - 0.93 ) . CONCLUSION Based on our findings , combination prophylaxis against post CABG AF with oral atorvastatin plus vitamin C is significantly more effective than single oral atorvastatin ",
"The protective effects of high-dose ascorbic acid ( 250 mg/kg ) on the myocardium were observed in 85 patients undergoing Cardiopulmonary Bypass ( CPB ) . The changes in serum Malonyldialdehyde ( MDA ) . Creatine Phosphokinase ( CPK ) , Creatine Phosphokinase isozyme ( CPK-MB ) and Lactic Dehydrogenase ( LDH ) in group B ( n = 45 , receiving ascorbic acid ) were lower ( p no ascorbic acid ) during and after CPB . The MDA remained at a higher level two days postoperatively ; CPK and CPK-MB , the sensitive and specific reflectors of myocardial injury , recovered very slowly in the control group ( A ) after the operation . The hearts in all the patients of group B resuscitated automatically intraoperatively while five cases ( 12.5 % ) needed defibrillation in group A. The cardiac index ( CI ) measured in ICU in group B was higher than in group A ( p ICU and hospital stays in group B than in group A. The results indicate that ascorbic acid can act as a scavenger of free radicals to decrease the peroxidation of the lipids present in the cell membrane and remove the radicals to protect the myocardium from ischemia-reperfusion injury effectively during and after open-heart operation",
"BACKGROUND Inflammation and oxidative stress have been recently implicated in the pathophysiology of atrial fibrillation ( AF ) . The aim of this study was to examine the potential benefit of vitamin C on the early recurrence rates and on inflammatory indices after successful cardioversion of persistent AF , as well as to investigate the time course of changes in these indices post-cardioversion . METHODS We prospect ively studied 44 consecutive patients after successful electrical cardioversion of persistent AF . All patients received st and ard treatment and were r and omised in one to one fashion to either oral vitamin C administration or no additional therapy . We followed-up the patients for 7 days performing successive measurements of white blood cell ( WBC ) count , C-reactive protein ( CRP ) , fibrinogen , and ferritin levels . RESULTS One week after successful cardioversion , AF recurred in 4.5 % of patients in the vitamin C group and in 36.3 % of patients in the control group ( p=0.024 ) . Compared to baseline values , inflammatory indices decreased after cardioversion in patients receiving vitamin C but did not change significantly in the control group . A significant variance was found in the serial measurements of WBC counts ( F=5.86 , p=0.001 ) and of fibrinogen levels ( F=4.10 , p=0.0084 ) in the two groups . In the vitamin C group CRP levels were lower on the seventh day ( p CRP and fibrinogen levels were higher in patients who relapsed into AF compared to patients who maintained sinus rhythm ( F=2.77 , p=0.044 and F=3.51 , p=0.017 , respectively ) . CONCLUSIONS These findings suggest that vitamin C reduces the early recurrence rates after cardioversion of persistent AF and attenuates the associated low-level inflammation . These effects indicate that therapeutic approaches targeting at inflammation and oxidative stress may exert favourable effects on atrial electrical remodeling",
"BACKGROUND I.V. infusions of vitamin E emulsion ( all-rac-alpha-tocopherol ) may reduce ischaemia-reperfusion injury after elective cardiac surgery . METHODS Forty patients participated in a prospect i ve , double-blind , placebo-controlled , r and omized trial , receiving either placebo or four doses ( 270 mg each ) of all-rac-alpha-tocopherol between 16 h before and 48 h after surgery . We determined plasma concentrations of vitamin E , vitamin C , malondialdehyde , creatine kinase , troponin I and interleukin 6 and other measures of clinical outcome . RESULTS Infusion of vitamin E caused normalization of vitamin E plasma concentrations during and after surgery , but had no effect on the early increase in malondialdehyde concentration or the decreases in antioxidative capacity and the water-soluble antioxidant vitamin C. CONCLUSIONS Normalization of plasma vitamin E concentrations with parenteral vitamin E emulsion does not affect biochemical markers of myocardial injury and does not affect clinical outcome after cardiac surgery",
"BACKGROUND This small study has determined the effect of vitamin C on myocardial reperfusion in patients undergoing elective percutaneous coronary intervention ( PCI ) . This study was to explore whether antioxidant vitamin C infusion before the procedure is able to affect the incidence of periprocedural myocardial injury ( PMI ) in patients undergoing PCI . METHODS In this prospect i ve single-centre r and omized study , 532 patients were r and omized into 2 groups : the vitamin C group , which received a 3-g vitamin C infusion within 6 hours before PCI , and a control group , which received normal saline . The primary end point was the troponin I-defined PMI , and the second end point was the creatine kinase (CK)-MB-defined PMI . Separate analyses using both end points were performed . PMI was defined as an elevation of cardiac biomarker values ( CK-MB or troponin I ) > 5 times the upper limit of normal ( ULN ) , alone or associated with chest pain or ST-segment or T-wave changes . RESULTS After PCI , the incidence of PMI was reduced , whether defined by troponin or by CK-MB , compared with the control group ( troponin I , 10.9 % vs 18.4 % ; P = 0.016 ; CK-MB , 4.2 % vs 8.6 % ; P = 0.035 ) . Logistic multivariate analysis showed that preprocedure use of vitamin C is an independent predictor of PMI either defined by troponin I ( odds ratio [ OR ] , 0.56 ; 95 % confidence interval [ CI ] , 0.33 - 0.97 ; P = 0.037 ) or by CK-MB ( OR , 0.37 ; 95 % CI , 0.14 - 0.99 ; P = 0.048 ) . CONCLUSIONS In patients undergoing elective PCI , preprocedure intravenous treatment with vitamin C is associated with less myocardial injury",
"This study was undertaken to evaluate the effects of alpha-tocopherol and ascorbic acid on markers of myocardial reperfusion injury and myocardial contractile function after coronary artery surgery . Forty-eight patients were divided into 4 groups ; 300 mg/day alpha-tocopherol was given orally to the patients in group I for 14 days . In groups II and III , 4 g of ascorbic acid was administered intravenously prior to induction and in the cardioplegic solution , respectively . Group IV was the control group . Blood sample s were taken to determine the concentrations of creatine phosphokinase MB isoenzyme , malondialdehyde , uric acid , ascorbic acid and alpha-tocopherol in the perioperative period . Left ventricular functions were determined by means of MUGA scans and echocardiography preoperatively and on the 3rd and 7th days , postoperatively . The changes in serum creatine phosphokinase MB and malondialdehyde were significantly lower in study groups , when compared with the control group . We observed no significant changes in ventricular function , requirement for ( + ) inotropic agents and the incidence of ventricular arrhythmias among the groups , postoperatively . Biochemical findings are consistent with the free radical hypothesis . But we could not confirm these data with hemodynamic findings . This is probably due to the population of low-risk elective coronary surgery patients in this study",
"BACKGROUND Atrial fibrillation is the most common arrhythmia following cardiac surgery . It is associated with increased hemodynamic instability , systemic embolization , and complications linked to anticoagulant therapy . Oxidative stress and consequent electrophysiological remodeling have been proposed as a cause of postoperative atrial fibrillation . Ascorbic acid supplementation was suggested as a novel and effective preventive agent . The aim of this study was to evaluate the capability of ascorbic acid to reduce the incidence of postoperative atrial fibrillation in coronary artery bypass grafting ( CABG ) patients . METHODS A prospect i ve r and omized single-center trial was conducted in patients scheduled for an elective on-pump CABG surgery . Subjects in the ascorbic acid group received 2 g of ascorbic acid 24h and 2h before the surgery and 1 g twice a day for five days after the surgery . Postoperatively , the patients were monitored for atrial fibrillation and other complications . RESULTS The ascorbic acid group consisted of 52 patients and the control group included 53 patients . The groups were well matched for baseline demographics , preoperative medications , comorbidities , and had similar intraoperative characteristics . The incidence of atrial fibrillation in the ascorbic acid group was 13.5 % and 18.9 % in the control group ( p=0.314 ) . No difference was found between groups in the time of occurrence of atrial fibrillation ( 3.71±1.89 vs. 2.91±1.58 days after the surgery ; p=0.342 ) . There was also no difference in the other observed postoperative complications . CONCLUSIONS The results of this study do not support the effectiveness of ascorbic acid supplementation in reducing the incidence of postoperative atrial fibrillation in elective on-pump CABG patients",
"Because adrenergic beta antagonists are not sufficient to prevent atrial fibrillation after coronary artery bypass grafting , this prospect i ve , r and omized trial was design ed to evaluate the effects of ascorbic acid as an adjunct to beta-blockers . Fifty patients formed our ascorbic acid group , and another 50 patients formed our control group . All patients were older than 50 years , were scheduled to undergo coronary artery bypass grafting , and had been treated with beta-blockers for at least 1 week before surgery . The mean age of the population was 60.19+/-7.14 years ; 67 % of the patients were men . Patients in the ascorbic acid group received 2 g of ascorbic acid on the night before the surgery and 1 g twice daily for 5 days after surgery . Patients in the control group received no ascorbic acid . Patients in both groups continued to receive beta-blockers after surgery . Telemetry monitoring was performed in the intensive care unit , and Holter monitoring was performed for 4 days thereafter . The incidence of postoperative atrial fibrillation was 4 % in the ascorbic acid group and 26 % in the control group ( odds ratio , 0.119 ; 95 % confidence interval , 0.025 - 0.558 , P = 0.002 ) . We conclude that ascorbic acid is effective , in addition to being well-tolerated and relatively safe . Therefore , it can be prescribed as an adjunct to beta-blockers for the prophylaxis of post-bypass atrial fibrillation",
"PURPOSE The effect of ascorbic acid on inflammatory markers after cardiothoracic surgery ( CTS ) was studied . METHODS In this r and omized , double-blind , placebo-controlled trial , patients undergoing cardiopulmonary bypass graft surgery or valve replacement surgery from April 2009 through March 2010 at Hartford Hospital were r and omized to receive ascorbic acid ( 2-g loading dose followed by 500 mg every 12 hours ) or matching placebo the evening before surgery and for four days postoperatively . Inflammatory mediators were measured preoperatively and on postoperative days 1 - 4 . Intergroup comparisons were performed using two-tailed t tests and Fisher 's exact test . Multiple comparisons were conducted using repeated analyses of variance with Bonferroni tests . RESULTS Of the 62 patients screened , 24 met the study inclusion criteria . Of these , 13 were assigned to receive ascorbic acid and 11 received placebo . Ascorbic acid did not affect the natural course of inflammatory marker rise for C-reactive protein ( CRP ) concentration , white blood cell ( WBC ) count , or fibrinogen concentration versus placebo at any evaluated time point ( p > 0.05 for all intergroup comparisons ) . Intragroup analyses demonstrated significant differences among baseline and postoperative measures of all inflammatory mediators ( p inflammatory markers between patients undergoing cardiothoracic surgery with or without cardiopulmonary bypass , regardless of treatment group . CONCLUSION Ascorbic acid did not attenuate the rise in inflammatory markers after CTS when compared with placebo . The use of off-pump surgery did not significantly change the levels of CRP and fibrinogen or the WBC count postoperatively when compared with on-pump surgery with a biocompatible polymer coating"
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41181a1c-06ff-11f0-808a-c43d1ab1c353
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Aim This systematic review aim ed at investigating the effectiveness of structured education ( SE ) in improving glycemic control and psychological outcomes in adolescent and adult patients with type 1 diabetes . Methods Electronic data bases ( EMBASE , Medline , PubMed , and the Cochrane Library ) and the reference lists of included studies were search ed from the beginning of the data base through April 2019 . R and omized controlled trials comparing SE with a control condition and reporting a change in glycosylated hemoglobin ( HbA1c ) level were included . The primary outcome was glycemic control measured by HbA1c . Secondary outcomes were diabetes-related distress , well-being , depression , and quality of life . Results Eighteen studies representing 2759 patients were included . Twelve studies targeted adolescents and six targeted adults . Adolescent patients who were r and omized to the intervention group did not show significant improvement of HbA1c in the short ( SMD = −0.04 ; 95 % CI : −0.14 to 0.06 ; P=0.41 ) , medium ( SMD = −0.03 ; 95 % CI : −0.13 to 0.07 ; P=0.41 ) , medium ( SMD = −0.03 ; 95 % CI : −0.13 to 0.07 ; P=0.41 ) , medium ( SMD = −0.03 ; 95 % CI : −0.13 to 0.07 ; P=0.41 ) , medium ( SMD = −0.03 ; 95 % CI : −0.13 to 0.07 ; P=0.41 ) , medium ( SMD = −0.03 ; 95 % CI : −0.13 to 0.07 ; Conclusions Development of more efficient SE programs according to the patients ' personal characteristics is needed
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"AIMS To evaluate the effectiveness of a family-centred group education programme , in adolescents with Type 1 diabetes . METHODS Three hundred and five adolescents with Type 1 diabetes ; age 13.1 ± 1.9 years , diabetes duration 5.6 ± 3.3 years , BMI 20.9 ± 3.7 kg/m(2 ) , HbA(1c ) 78 ± 6 mmol/mol ( 9.3 ± 1.9 % ) were r and omly allocated to the Families and Adolescents Communication and Teamwork Study ( FACTS ) diabetes education programme ; ( six 90-min monthly sessions attended by parents and adolescents incorporating skills training and family teamwork ) or conventional clinical care . Primary outcome was HbA(1c ) at 18 months ( 12 months post-intervention ) . Secondary outcomes were HbA(1c ) at 9 months , psychosocial outcomes , adolescent quality of life , well-being , family responsibility and insulin dose adjustment behaviours at 12 months ( 6 months post-intervention ) and episodes of severe hypoglycaemia and diabetic ketoacidois during the 12 months post-intervention . All analyses are intention to treat . RESULTS Session attendance was poor with 48/158 families ( 30.4 % ) not attending any sessions and only 75/158 ( 47.5 % ) families attending ≥ 4 group education sessions . All biomedical and psychosocial outcomes were comparable between groups . At 18 months there was no significant difference in HbA(1c ) in either group and no between-group differences over time : intervention group 75 mmol/mol ( 9.0 % ) to 78 mmol/mol ( 9.3 % ) , control group 77 mmol/mol ( 9.2 % ) to 80 mmol/mol ( 9.5 % ) . Adolescents perceived no changes in parental input at 12 months . CONCLUSION Poor attendance of group education sessions delivered in routine clinics was a major challenge . More personalized educational approaches may be required to support and motivate families who are struggling to integrate the dem and s of intensive insulin regimens into their daily lives",
"Aims /hypothesisThe aim of this study was to evaluate the implementation of a course teaching flexible , intensive insulin therapy on glycaemic control and severe hypoglycaemia in routine care . Methods This is a continuous quality -assurance project involving hospital diabetes centres . Every third year each centre re-examines 50 consecutive patients ( evaluation sample ) 1 year after participation in the course . Ninety-six diabetes centres in Germany participated and 9,583 patients with type 1 diabetes ( 190 evaluation sample s ) were re-examined between 1992 and 2004 . The intervention was a 5-day inpatient course for groups of up to ten patients with a fixed curriculum of education and training for dietary flexibility and insulin adjustment . The main outcome measures were HbA1c and severe hypoglycaemia . Results Mean baseline HbA1c was 8.1 % , and had decreased to 7.3 % at follow-up ; incidence of severe hypoglycaemia was 0.37 events per patient per year prior to intervention and 0.14 after intervention . In mixed-effects models adjusted for effects of centres , age and diabetes duration , the mean difference was −0.7 % ( 95 % CI −0.9 to −0.6 % , p the incidence of severe hypoglycaemia was three-fold higher in the lowest quartile than in the highest quartile of HbA1c , whereas the risk was comparable across the range of HbA1c values after intervention . Conclusions /interpretationImplemented as part of a continuous quality -assurance programme the self-management programme is effective and safe in routine care . Improvement of glycaemic control can be achieved without increasing the risk of severe hypoglycaemia",
"The purpose of this pilot study was to test the hypothesis that adolescents with type 1 diabetes can learn to become better problem solvers in diabetes self-care and thereby improve their metabolic control . METHODS Fifty-three adolescents aged 13 to 17 with type 1 diabetes were r and omly assigned to either a 6-week problem-solving diabetes education program or to a control group ( usual care ) . Al C levels were obtained as well as assessment s of problem solving , frequency of behavior , level of responsibility , and 24-hour behavior recall at baseline and 6 months . RESULTS The experimental group participants showed significantly improved problem-solving test scores and Al C values from baseline to 6 months , changes not evident in the control group . At 6 months , the experimental group participants were doing blood glucose testing more often than those in the control group . However , there was no significant difference in problem-solving test scores or Al C values . CONCLUSIONS This 6-week intervention for adolescents with diabetes result ed in better problem-solving skills , more frequent blood glucose testing , and improved Al C values . The results suggest that a diabetes problem-solving program for adolescents can be effective in improving metabolic control",
"OBJECTIVE To examine the impact of a Cognitive Behavior Therapy (CBT)-based intervention on HbA(1c ) , self-care behaviors and psychosocial factors among poorly controlled adult type 1 diabetes patients . METHODS Ninety-four type 1 diabetes patients were r and omly assigned to either an intervention group or a control group . The intervention was based on CBT and was mainly delivered in group format , but individual sessions were also included . All subjects were provided with a continuous glucose monitoring system ( CGMS ) during two 3-day periods . HbA(1c ) , self-care behaviors and psychosocial factors were measured up to 48 weeks . RESULTS Significant differences were observed with respect to HbA(1c ) ( P well-being ( P diabetes-related distress ( P frequency of blood glucose testing ( P avoidance of hypoglycemia ( P perceived stress ( P anxiety ( P depression ( P non-severe hypoglycemia , which yielded a higher score in the intervention group . CONCLUSION This CBT-based intervention appears to be a promising approach to diabetes self-management . PRACTICE IMPLICATION S Diabetes care may benefit from applying tools commonly used in CBT . For further scientific evaluation in clinical practice , there is a need for specially educated diabetes care teams , trained in the current approach , as well as cooperation between diabetes care teams and psychologists trained in CBT",
"AIM To assess the effect of a 5-day structured education course ( Kids in Control of Food ; KICk-OFF ) on biomedical and psychological outcomes in young people with Type 1 diabetes . METHODS This was a cluster-r and omized trial involving 31 UK paediatric centres . Participants were recruited prior to stratified centre r and omization . Intervention centres delivered KICk-OFF courses , whereas control centres delivered usual care . Participants were 11 - 16 years of age and had Type 1 diabetes for at least one year . The KICk-OFF course was delivered by trained educators to eight participants per course . Glycaemic control and quality of life were measured at baseline , 6 , 12 and 24 months . Secondary outcomes were hypoglycaemia , ketoacidosis , fear of hypoglycaemia and diabetes self-efficacy . RESULTS Three hundred and ninety-six participants provided baseline data ( 199 intervention and 197 control ) . At 6 and 12 months the intervention group showed significantly improved total generic quality of life scores compared with controls ( baseline : 80 vs. 82 ; 6 months : 82 vs. 82 ; P = 0.04 ) . Across the whole intervention group mean HbA1c levels were not significantly different from controls ; baseline HbA1c mean ( 95 % confidence interval ) , 78 mmol/mol ( 75 - 81 ) vs. 76 mmol/mol ( 74 - 79 ) [ 9.3 % ( 9 - 9.6 % ) vs. 9.1 % ( 8.9 - 9.4 % ) ; 24 months : 77 mmol/mol ( 74 - 79 ) vs. 78 mmol/mol ( 75 - 81 ) ( 9.2 % ( 8.9 - 9.4 % ) vs. 9.3 % ( 9 - 9.6 % ) ] , adjusted mean difference , -2.0 mmol/mol ( 6.5 - 2.5 ) [ 2.3 % ( -2.7 % to 2.4 % ) ] , P = 0.38 . CONCLUSIONS Attending a KICk-OFF course was associated with significantly improved total quality of life scores within 6 months . Glycaemic control , as measured by HbA1c , was no different at 24 months . ( Clinical Trial Registry No : IS RCT N3704268 )",
"Although both diabetes and the efficacy of medical management are international issues , psycho-educational interventions might be culturally bound . Blood Glucose Awareness Training ( BGAT ) is a psycho-educational program for patients with type 1 diabetes mellitus . It is focused on improving recognition and management of extreme blood glucose levels , and is the best documented American psycho-educational program for this purpose . A r and omized controlled clinical trial of BGAT 's long-term benefits in a non-American setting has been lacking . One hundred and eleven adults with type 1 diabetes mellitus from Switzerl and and Germany participated . After a 6 months baseline assessment , subjects were r and omly assigned to receive either 2 months of BGAT ( n = 56 ) or a physician-guided self-help control intervention ( n = 55 ) . BGAT improved recognition of low ( p = 0.008 ) , high ( p = .03 ) , and overall blood glucose ( p = 0.001 ) , and reduced frequency of severe hypoglycemia ( p = 0.04 ) , without compromising metabolic control . BGAT reduced both the external locus of control ( p fear of hypoglycemia ( p BGAT was efficacious in reducing adverse clinical events and achieving clinical ly desirable goals in a European , as well as American setting",
"OBJECTIVE — Studies showing that family communication and conflict resolution are critical to effective management of type 1 diabetes in adolescents have stimulated interest in evaluating psychological treatments targeting these processes . Previous trials have shown that Behavioral Family Systems Therapy ( BFST ) improved parent-adolescent relationships but not treatment adherence or glycemic control . This study evaluates a revised intervention , BFST for Diabetes ( BFST-D ) , modified to achieve greater impact on diabetes-related family conflict , treatment adherence , and metabolic control . RESEARCH DESIGN AND METHODS —A sample of 104 families of adolescents with inadequate control of type 1 diabetes was r and omized to either remain in st and ard care ( SC ) or to augmentation of that regimen by 12 sessions of either a multifamily educational support ( ES ) group or 12 sessions of BFST-D over 6 months . Pertinent measures were collected at baseline and at follow-up evaluations at 6 , 12 , and 18 months . RESULTS —BFST-D was significantly superior to both SC and ES in effects on A1C , while effects on treatment adherence and family conflict were equivocal . Improvement in A1C appeared to be mediated by improvement in treatment adherence . A significantly higher percentage of BFST-D youth achieved moderate or greater improvement ( > 0.5 SD ) in treatment adherence compared with the SC group at each follow-up and the ES group at 6 and 18 months . Change in treatment adherence correlated significantly with change in A1C at each follow-up . CONCLUSIONS —These results support the efficacy of BFST-D in improving A1C , but further research is needed to identify the mechanisms of this effect and to achieve cost-effective dissemination of the intervention",
"Aims Intensive 5-day educational interventions for people with Type 1 diabetes have shown improved outcomes in a number of European studies . The aim was to assess the effectiveness of a brief ( 2.5 days ) psycho-educational intervention . Methods Our r and omized trial in a secondary -care setting had 54 and 60 participants allocated to intervention and control groups , respectively . Primary outcomes were HbA1c and severe hypoglycaemia . Secondary outcomes were blood pressure , weight , height , lipids and psychometric profile . Results HbA1c showed no statistically significant change at 3 months [ difference = 0.01 , 95 % confidence interval ( CI ) –0.23 , 0.26 , P = 0.92 ] , 6 months ( difference = –0.06 , 95 % CI –0.32 , 0.20 , P = 0.67 ) and 12 months ( difference = 0.01 , 95 % CI –0.30 , 0.32 , P = 0.94 ) . Incidence of severe hypoglycaemia ( per patient per year ) in the intervention group ( 0.41 ) and control group ( 0.48 ) was not statistically different . Treatment satisfaction improved at 3 months ( difference = 9.4 , 95 % CI 5.2 , 13.6 , P = 0.0005 ) , 6 months ( difference = 10.4 , 95 % CI 6.0 , 14.8 , P = 0.0005 ) and 12 months ( difference = 7.1 , 95 % CI 2.1 , 12.1 , P = 0.006 ) . The ‘ Managing psychological aspects ’ and ‘ Setting and achieving goals ’ dimensions of the Diabetes Empowerment Scale also showed significant improvement at 3 , 6 and 12 months . Diabetes Knowledge Test , Illness Perception Question naire , Hypoglycaemia Fear Scale and Short Form 36 showed no significant change . Conclusions This brief intervention had no significant impact on HbA1c or severe hypoglycaemia , but improved diabetes treatment satisfaction and patient empowerment . Current Controlled Trials IS RCT N75807800",
"OBJECTIVE To describe the short-term results of a controlled trial of Behavioral Family Systems Therapy ( BFST ) for families of adolescents with diabetes . METHODS We r and omized 119 families of adolescents with diabetes to 3 months ' treatment with either BFST , an education and support Group ( ES ) , or current therapy ( CT ) . Family relationships , psychological adjustment to diabetes , treatment adherence and diabetic control were assessed at baseline , after 3 months of treatment ( reported here ) , and 6 and 12 months later . RESULTS Compared with CT and ES , BFST yielded more improvement in parent-adolescent relations and reduced diabetes-specific conflict . Effects on psychological adjustment to diabetes and diabetic control were less robust and depended on the adolescent 's age and gender . There were no effects on treatment adherence . CONCLUSIONS BFST yielded some improvement in parent-adolescent relationships ; its effects on diabetes outcomes depended on the adolescent 's age and gender . Factors mediating the effectiveness of BFST must be clarified",
"The Diabetes Control and Complications Trial ( DCCT ) ( 1 ) and its observational follow-up , the Epidemiology of Diabetes Interventions and Complications ( EDIC ) Study ( 2 ) , are celebrating the 30th anniversary since the start of the DCCT and 20th since the reporting of the DCCT primary results ( 3 ) . During the past three decades , our underst and ing of the relationship between metabolic control and complications and the treatment of type 1 diabetes ( T1D ) has been transformed by the results of DCCT/EDIC . Most importantly , the long-term prospect s for patients have dramatically improved with the adoption of intensive therapy design ed to achieve near-normal glycemia as the st and ard of care of T1D . In this Perspective , we present an overview of the major scientific advances provided by the DCCT/EDIC Research Group , the result ing changes in therapy that have improved long-term outcomes in patients with T1D worldwide , and the challenges that remain . # # # Background and rationale . After the introduction of insulin therapy in 1922 , type 1 diabetes ( T1D ) was transformed from a uniformly fatal disease to a chronic degenerative one ( 4 ) . During the 1930–1960s , the development of chronic complications affecting the eyes , kidneys , peripheral and autonomic nervous system , and a substantially increased risk of cardiovascular disease ( CVD ) were observed in patients who had survived > 20 years with the disease ( 5 ) . The origin of these newly discovered complications was debated vigorously , and theories to explain them abounded ( 4,6 ) . The debate led to two opposing philosophies of diabetes treatment : one in which treatment to achieve glucose concentrations as low as possible was endorsed and another in which glycemic levels were thought to be inconsequential , at least with regard to the pathogenesis of long-term complications ( 7,8 ) . Although the debate regarding the so-called glucose hypothesis was vigorous , it was largely academic , since objective means of measuring long-term glycemia and of achieving near-normal glycemia did not",
"Introduction Type 1 diabetes ( T1D ) in children and adolescents is increasing worldwide with a particular increase in children Fewer than 1 in 6 children and adolescents achieve recommended glycated hemoglobin ( HbA1c ) values . Methods A pragmatic , cluster-r and omized controlled trial assessed the efficacy of a clinic-based structured educational group incorporating psychological approaches to improve long-term glycemic control , quality of life and psychosocial functioning in children and adolescents with T1D . 28 pediatric diabetes services were r and omized to deliver the intervention or st and ard care . 362 children ( 8–16 years ) with HbA1c≥8.5 % were recruited . Outcomes were HbA1c at 12 and 24 months , hypoglycemia , admissions , self-management skills , intervention compliance , emotional and behavioral adjustment , and quality of life . A process evaluation collected data from key stakeholder groups in order to evaluate the feasibility of delivering the intervention . Results 298/362 patients ( 82.3 % ) provided HbA1c at 12 months and 284/362 ( 78.5 % ) at 24 months . The intervention did not improve HbA1c at 12 months ( intervention effect 0.11 , 95 % CI −0.28 to 0.50 , p=0.584 ) , or 24 months ( intervention effect 0.03 , 95 % CI −0.36 to 0.41 , p=0.891 ) . There were no significant changes in remaining outcomes . 96/180 ( 53 % ) families in the intervention arm attended at least 1 module . The number of modules attended did not affect outcome . Reasons for low uptake included difficulties organizing groups and work and school commitments . Those with highest HbA1cs were less likely to attend . Mean cost of the intervention was £ 683 per child . Conclusions Significant challenges in the delivery of a structured education intervention using psychological techniques to enhance engagement and behavior change delivered by diabetes nurses and dietitians in routine clinical practice were found . The intervention did not improve HbA1c in children and adolescents with poor control . Trial registration number IS RCT N52537669 , results",
"AIMS The Families , Adolescents and Children 's Teamwork Study ( FACTS ) is a family-centred structured education programme for children and adolescents with Type 1 diabetes . It aims to integrate group-based diabetes education into routine care , enhance parental responsibility for self management and improve glycaemic control . METHODS A r and omized wait-list control group study allocated participants to either the immediate ( four educational sessions during year 1 ) or delayed intervention ( four educational sessions during year 2 ) . In both groups , glycated haemoglobin ( HbA1c ) was measured 3-monthly and participants completed the Paediatric Quality of Life Inventory ( PedsQL ) , Problem Areas in Diabetes Scale ( PAID ) and Diabetes Family Responsibility Question naire ( DFRQ ) before and after the intervention . RESULTS Intention-to-treat analysis showed no significant difference in HbA1c or parental responsibility between participants r and omized to the immediate or delayed programme . However , during 12 months ' follow-up , families who attended > or = 2 sessions reported increased parental involvement ( P = 0.01 ) , and in children/adolescents who attended > or = 2 sessions HbA1c fell by 0.29 % compared with an increase of 0.11 % in non-attenders ( P = 0.04 ) . CONCLUSION This family-centred education programme has been integrated into paediatric diabetes care with potential benefits on parental involvement and glycaemic control , but further study is warranted before routine application into clinical care",
"OBJECTIVE Little is known about the use of psychosocial interventions in children younger than adolescence with type 1 diabetes ( T1D ) and their parents . We report preliminary short-term outcomes of a r and omized controlled trial of coping skills training ( CST ) compared with group education ( GE ) in school-aged children with T1D and their parents . METHODS One hundred and eleven children ( range = 8 - 12 yr ) with T1D for at least 6 months ( 3.71 + /- 2.91 yr ) were r and omized to CST ( 55.6 % female ( F ) ; 81.5 % white ( W ) ) or GE ( 69.7 % F ; 90.9 % W ) . Children and parents ( n = 87 ) who completed the intervention , baseline , 1- and 3-month data are included . Children completed measures of self-efficacy , coping , and quality of life ; parents completed measures of family functioning ( adaptability and cohesion ) , diabetes-related conflict , parent depression , and parent coping . Metabolic control was assessed with glycosylated hemoglobin A1c . Mixed-model repeated measures anova was used to analyze the data . RESULTS CST and GE group composition was generally comparable . Children had good psychosocial adaptation and metabolic status . CST parents reported significantly more improvement in family adaptability compared with GE parents , and a trend was seen indicating that CST children showed greater improvement in life satisfaction than GE children . Effect sizes for this short-term follow-up period were small , but group participants were receptive to the intervention and reported positive gains . CONCLUSIONS In these preliminary results , CST and GE were more similar than different across multiple measure of psychosocial adaptation , although CST showed promising statistical trends for more adaptive family functioning and greater life satisfaction . Longer term follow-up is underway",
"BACKGROUND Youth with type 1 diabetes do not count carbohydrates accurately , yet it is an important strategy in blood glucose control . OBJECTIVE The study objective was to determine whether a nutrition education intervention would improve carbohydrate counting accuracy and glycemic control . DESIGN We conducted a r and omized , controlled nutrition intervention trial that was recruited from February 2009 to February 2010 . SUBJECTS Youth ( 12 to 18 years of age , n = 101 ) with type 1 diabetes were screened to identify those with poor carbohydrate counting accuracy , using a previously developed carbohydrate counting accuracy test covering commonly consumed foods and beverage items presented in six mixed meals and two snacks . All participants ( n = 66 , age = 15 ± 3 years , 41 male , diabetes duration = 6 ± 4 years , hemoglobin A1c [ HbA1c ] = 8.3 % ± 1.1 % ) were r and omized to the control or intervention group at the baseline visit . The intervention group attended a 90-minute class with a registered dietitian/certified diabetes educator and twice kept 3-day food records , which were used to review carbohydrate counting progress . MAIN OUTCOME MEASURES Carbohydrate counting accuracy ( measured as described ) and HbA1c were evaluated at baseline and 3 months to determine the effectiveness of the intervention . STATISTICAL ANALYSES PERFORMED t Tests , Spearman correlations , and repeated measures models were used . RESULTS At baseline , carbohydrate content was over- and underestimated in 16 and 5 of 29 food items , respectively . When foods were presented as mixed meals , participants either significantly over- or underestimated 10 of the 9 meals and 4 snacks . After 3 months of follow-up , HbA1c decreased in both the intervention and control groups by -0.19 % ± 0.12 % ( P = 0.12 ) and -0.08 % ± 0.11 % ( P = 0.51 ) , respectively ; however , the overall intervention effect was not statistically significant for change in HbA1c or carbohydrate counting accuracy . CONCLUSIONS More intensive intervention might be required to improve adolescents ' carbohydrate counting accuracy and nutrition management of type 1 diabetes . Additional research is needed to translate nutrition education into improved health outcomes",
"BACKGROUND AND AIMS We showed that continuing education can be embedded into routine diabetes care by seeing patients in small groups rather than individually . Group care was cost-effective in improving quality of life , knowledge of diabetes , health behaviours and clinical outcomes in people with type 2 diabetes . The aim of this study was to verify if group care can also be applied to type 1 diabetes . METHODS AND RESULTS R and omized , controlled clinical trial comparing 31 patients managed by group care with 31 managed by traditional one-to-one care . A syllabus was built and later remodulated with the patients in a series of focus-group meetings . The primary end-point was changes in quality of life . Secondary end-points were : knowledge of diabetes , health behaviours , HbA1c and circulating lipids . Differential costs to the Italian National Health System and to the patients were also calculated . After 3 years , quality of life improved among patients on group care , along with knowledge and health behaviours ( p Knowledge added its effects to those of group care by independently influencing behaviours ( p=0.004 ) while quality of life changed independently of either ( p quality of life worsened ( p knowledge and behaviours remained unchanged . HDL cholesterol increased among patients on group care ( p=0.027 ) and total cholesterol decreased in the controls ( p HbA1c decreased , though not significantly , in both . Direct costs for group and one-to-one care were Euros 933.19 and Euros 697.10 per patient , respectively , giving a cost-effectiveness ratio of Euros 19.42 spent per point gained in the quality of life scale . CONCLUSIONS Group care is applicable and also cost-effective in type 1 diabetes . It improves quality of life , knowledge and behaviours . Future programme adjustments should strive to impact more on metabolic control",
"AIM To examine the effects of group visits and computer-assisted consultations on quality of life and glycaemic control in adolescents with Type 1 diabetes . METHODS A total of 116 adolescents , aged 11 - 17 years , and their parents were r and omly assigned to an intervention ( n = 62 ) or a control group ( n = 54 ) . The intervention group was invited to a 15-month programme comprising group visits and computer-assisted consultations . The control group was offered traditional out-patient consultations . Outcomes included changes in HbA(1c ) and the adolescents ' assessment of generic and disease-specific health-related quality of life measured by the Child Health Question naire ( CHQ-CF87 ) and the Diabetes Quality of Life Question naire ( DQOL ) , respectively . RESULTS One hundred and one adolescents ( 55/46 ) agreed to participate , mean age 14.2 years ( sd 1.5 ) , mean diabetes duration 6.5 years ( sd 3.6 , range 1 - 16 years ) , mean HbA(1c ) 9.3 % ( sd 1.4 , range 6.1 - 12.8 % ) . Eighty-three ( 72 % ) completed the question naires at follow-up ( intervention/control 45/38 ) . There were significant age by r and omization group interactions for diabetes-related impact ( P = 0.018 ) , diabetes-related worries ( P = 0.004 ) , mental health ( P = 0.046 ) and general behaviour ( P = 0.029 ) , implying that the intervention was effective in older adolescents ( above 13 - 14 years ) . No significant effects on mean HbA(1c ) were identified . CONCLUSIONS Group visits and computer-assisted consultations had beneficial effects on health-related quality of life in older adolescents , the role of this intervention being question able in younger adolescents",
"BACKGROUND Intensive insulin therapy is the gold st and ard therapy for type 1 diabetes ( T1D ) patients . To achieve optimal glycemic control , adjustments of insulin dose at mealtimes must be made taking into account several parameters : blood glucose levels , insulin/carbohydrate ratio , carbohydrate intake , and physical activity . Calsulin ( Thorpe Products Ltd. , Cambridge , UK ) is a new tool for the administration of insulin dose before each meal . The aim of this study was to evaluate the efficacy of Calsulin on metabolic control in T1D patients undergoing intensive insulin therapy . SUBJECTS AND METHODS Forty consecutive patients affected by T1D , 18 - 65 years old , with disease duration of > 1 year , were r and omized to Calsulin or to the control group . Hemoglobin A1c ( HbA1c ) was evaluated at entry into the study and at 3- and 6-month follow-ups . Paired t test ( two tailed ) and analysis of variance were used to evaluate differences in HbA1c at 3 and 6 months in the two groups . RESULTS HbA1c at entry was 7.9 ± 1.0 % ( SD ) in the Calsulin-treated group and 7.8 ± 1.6 % ( SD ) in control patients ( P not significant ) . Data showed a slight improvement in HbA1c levels at 3 months in the Calsulin-treated group ( -0.61 % vs. -0.14 % difference , respectively ; P not significant ) . At the 6-month follow-up , a significant reduction in HbA1c levels was observed in the Calsulin-treated group versus the control group ( -0.85 % vs. -0.07 % difference , respectively ; P CONCLUSIONS Calsulin is an acceptable and practical tool that makes the process of calculating insulin doses easy to use , and , most importantly , it improves metabolic control as shown by a significant reduction of HbA1c levels",
"Objectives To evaluate whether a course teaching flexible intensive insulin treatment combining dietary freedom and insulin adjustment can improve both glycaemic control and quality of life in type 1 diabetes . Design R and omised design with participants either attending training immediately ( immediate DAFNE ) or acting as waiting list controls and attending “ delayed DAFNE ” training 6 months later . Setting Secondary care diabetes clinics in three English health districts . Participants 169 adults with type 1 diabetes and moderate or poor glycaemic control . Main outcome measures Glycated haemoglobin ( HbA1c ) , severe hypoglycaemia , impact of diabetes on quality of life ( ADDQoL ) . Results At 6 months , HbA1c was significantly better in immediate DAFNE patients ( mean 8.4 % ) than in delayed DAFNE patients ( 9.4 % ) ( t=6.1 , P 0.0001 ) . The impact of diabetes on dietary freedom was significantly improved in immediate DAFNE patients compared with delayed DAFNE patients ( t= − 5.4 , P was the impact of diabetes on overall quality of life ( t=2.9 , P were also significantly improved , but severe hypoglycaemia , weight , and lipids remained unchanged . Improvements in “ present quality of life ” did not reach significance at 6 months but were significant by 1 year . Conclusion Skills training promoting dietary freedom improved quality of life and glycaemic control in people with type 1 diabetes without worsening severe hypoglycaemia or cardiovascular risk . This approach has the potential to enable more people to adopt intensive insulin treatment and is worthy of further investigation",
"OBJECTIVE Short-term studies with automated systems that suspend basal insulin when hypoglycemia is predicted have shown a reduction in hypoglycemia ; however , efficacy and safety have not been established in long-term trials . RESEARCH DESIGN AND METHODS We conducted a 6-month , multicenter , r and omized controlled trial in children and adolescents with type 1 diabetes using the Medtronic MiniMed 640 G pump with Suspend before low ( predictive low-glucose management [ PLGM ] ) compared with sensor-augmented pump therapy ( SAPT ) alone . The primary outcome was percentage time in hypoglycemia with sensor glucose ( SG ) intent-to-treat analysis of 154 subjects , 74 subjects were r and omized to SAPT and 80 subjects to PLGM . At baseline , the time with SG reduction in hypoglycemia compared with SAPT ( % time SG P 0.0001 ) . Hypoglycemic events ( SG 20 min ) also declined with PLGM ( SAPT vs. PLGM : events/patient-year 227 vs. 139 , P difference in glycated hemoglobin ( HbA1c ) at 6 months ( SAPT 7.6 ± 1.0 % vs. PLGM 7.8 ± 0.8 % , P = 0.35 ) . No change in quality of life measures was reported by participants /parents in either group . There were no PLGM-related serious adverse events . CONCLUSIONS In children and adolescents with type 1 diabetes , PLGM reduced hypoglycemia without deterioration in glycemic control "
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OBJECTIVE To identify and critically appraise the evidence for the effectiveness of custom orthoses for the foot and ankle in rheumatoid arthritis . METHODS Studies were identified in appropriate electronic data bases ( from 1950 to March 2011 ) . The search term " rheumatoid arthritis " with " foot " and " ankle " and related terms were used in conjunction with " orthoses " and synonyms . Included studies were quantitative longitudinal studies and included r and omized controlled trials ( RCTs ) , case-control trials , cohort studies , and case series studies . All outcome measures were investigated . Quality assessment was conducted using the Cochrane Collaboration criteria with additional criteria for sample population representativeness , quality of statistical analysis , and compliant intervention use and presence of co interventions . Meta-analyses were conducted for outcome domains with multiple RCTs . Qualitative data synthesis was conducted for the remaining outcome domains . Levels of evidence were then assigned to each outcome measure . RESULTS The inclusion criteria were met by 17 studies . Two studies had high quality for internal validity and 3 studies had high quality for external validity . No study had high quality for both internal and external validity . Six outcome domains were identified . There was weak evidence for custom orthoses reducing pain and forefoot plantar pressures . Evidence was inconclusive for foot function , walking speed , gait parameters , and reducing hallux abductovalgus angle progression . CONCLUSION Custom orthoses may be beneficial in reducing pain and elevated forefoot plantar pressures in the rheumatoid foot and ankle . However , more definitive research is needed in this area
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"Rheumatoid arthritis ( RA ) frequently causes foot pain and swelling that affect ambulation . Pharmaceutical management of pain and disability is st and ard in clinical practice . The use of functional posted foot orthoses , as an adjunct to pharmaceutical treatment , is a promising treatment for managing foot pain and disability in RA . Its effectiveness , however , has not been rigorously evaluated . We performed a double-blind clinical trial using foot orthoses vs. placebo orthoses in the management of the rheumatoid arthritic foot , while subjects continued customary treatment . On the basis of findings of no effect on disability and pain measures , this study indicates no benefit of functional posted foot orthoses over placebos",
"Background Conservative management of foot problems in patients with rheumatoid arthritis ( RA ) may consist of the prescription of customised foot orthoses . Indications for foot orthoses are not clear and the effectiveness of the intervention is highly variable among patients . Knowledge on which patients benefit the most from foot orthoses can help to select patients eligible for this type of intervention . The objective of the present study was to determine clinical and demographic factors that predict the outcome of customised foot orthoses on pain and disability in patients with RA . Methods A total of 135 RA patients who were supplied with customised foot orthoses were included in this prospect i ve cohort study . Pain and disability were measured before and after the intervention period using a Numeric Rating Scale ( NRS ) for foot pain , the Foot Function Index ( FFI ) , the Western Ontario and McMasters Universities Osteoarthritis Index ( WOMAC ) and a 10-meter walking test . The intervention period consisted of one or more appointments with the podiatrist during which the foot orthoses were customised . Swollen foot joint count , foot deformity scores , forefoot peak pressure , disease duration , age , gender , body mass index and baseline values of the outcome measures were selected as potential factors predicting outcome . Multivariate linear regression analyses were performed to determine factors associated with change in pain and disability ( at P NRS foot pain ( P = 0.018 ) , WOMAC pain ( P = 0.001 ) , FFI disability ( P = 0.003 ) and WOMAC physical function ( P = 0.002 ) . Age was negatively associated with the change score in 10 meter walking time ( P = 0.008 ) . For all outcome measures baseline values were positively associated with the change scores ( P self-reported foot pain and disability , and younger age predicted greater improvements in walking time after intervention with foot orthoses . Also , higher baseline values of pain and disability predicted greater improvements . Referral for conservative management with foot orthoses in the early stage of RA seems important when aim ing to achieve reduction in pain and improvement in daily activities",
"Purpose . To compare the effectiveness of functional foot orthoses and unshaped ( flat ) orthotic material on plantar pressure redistribution , forefoot pain reduction and walking ability in rheumatoid arthritis ( RA ) patients . Methods . Forty patients with RA were r and omised to receive unshaped material ( UM ) ( n = 20 ) or functional foot orthoses ( n = 20 ) . Plantar pressure measurement was performed with an F-scan system . Foot pain was assessed by the pain subscale of the Foot Function Index . Walking ability was assessed by the 6-min walking test . Investigations were performed at baseline , 1 week after the patient received shoes with orthoses and 6 months later . Results . Plantar pressures were significantly higher at painful than at non-painful foot areas . No differences in plantar pressure redistribution were found between the groups . Notable reduction of pain and improvement of activity ( walking ability ) was observed in both groups . Foot pain has moderate impact on the walking ability of RA patients . Conclusions . The study showed no clear advantage of functional foot orthoses over UM",
"Background Controlled clinical trials of health care interventions are either explanatory or pragmatic . Explanatory trials test whether an intervention is efficacious ; that is , whether it can have a beneficial effect in an ideal situation . Pragmatic trials measure effectiveness ; they measure the degree of beneficial effect in real clinical practice . In pragmatic trials , a balance between external validity ( generalizability of the results ) and internal validity ( reliability or accuracy of the results ) needs to be achieved . The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention . The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized . However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability . We are conducting two pragmatic r and omized controlled trials on interventions in the management of hypertension in primary care . We describe the design of the trials and the steps taken to deal with the competing dem and s of external and internal validity . Discussion External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions . Internal validity is maximized by decreasing contamination bias through cluster r and omization , and decreasing observer and assessment bias , in these non-blinded trials , through baseline data collection prior to r and omization , automating the outcomes assessment with 24 hour ambulatory blood pressure monitors , and blinding the data analysis . Summary Clinical trials conducted in community practice s present investigators with difficult method ological choices related to maintaining a balance between internal validity ( reliability of the results ) and external validity ( generalizability ) . The attempt to achieve method ological purity can result in clinical ly meaningless results , while attempting to achieve full generalizability can result in invalid and unreliable results . Achieving a creative tension between the two is crucial",
"BACKGROUND Insoles are regarded as an appropriate tool for the management of rheumatic foot disorders . However , a quality control for this purpose has not been established . In our study , the clinical effectiveness of insoles used in patients with rheumatic foot disorders was addressed . In addition , we sought to establish pedobarography as a means of quality control for orthotic management of the rheumatic foot . MATERIAL AND METHODS Our study included 20 rheumatoid arthritis patients with painful rheumatic foot deformities who were provided with insoles . Clinical data were obtained by physical examination and a 100-mm pain scale . Pedobarography was performed using the novel pedar cable system with new and individually design ed insoles and after a 6-month follow-up . A shoe-only trial served as control . The parameters maximum force , peak pressure , force-time integral , and average pressure were analyzed in anatomical regions and an individually defined overloaded forefoot region . RESULTS Clinical improvement was significant after a 6-month follow-up in spite of a heterogeneous group of patients . However , our results could not confirm consistent changes in plantar pressure distribution . CONCLUSION As a conclusion , further efforts are necessary to establish a quality control for orthotic management of the rheumatic foot",
"OBJECTIVE To investigate the clinical effectiveness of early foot orthosis intervention for painful correctable valgus deformity of the rearfoot in rheumatoid arthritis ( RA ) . METHODS Patients with RA were r and omized to receive custom manufactured rigid foot orthoses under podiatry supervision ( n = 50 ) or enter a control group ( n = 48 ) . The control group received foot orthoses only when prescribed under normal medical care . Foot pain and disability , using the Foot Function Index ( FFI ) , along with disease activity , tolerance , and adverse reactions , were serially measured over 30 mo continuous treatment . RESULTS The group assigned foot orthoses demonstrated an immediate clinical improvement , the effect peaking at 12 mo . At 30 mo the FFI total score was reduced by 23.1 % from baseline in the intervention group . Area under the curve analysis showed a statistically significant reduction in FFI scores for total score ( p = 0.026 ) , foot pain ( p = 0.014 ) , and foot disability ( p = 0.016 ) when intervention was compared to control scores . There were no confounding effects from differences between groups for disease activity or pharmacological or other management strategies . Most patients ( 96 % ) used their orthoses and most found them comfortable ( 97 % ) , although minor adverse reactions , such as tender spots , blisters , and callus , were reported in 30 % of patients in the early stages of treatment and persisted in 12 % for 30 mo . CONCLUSION Custom design ed foot orthoses used continuously over a 30 mo treatment period result ed in a reduction in foot pain by 19.1 % , foot disability by 30.8 % , and functional limitation by 13.5 % . Clinical effectiveness might be enhanced by their use in the early stages of rearfoot pain and deformity",
"OBJECTIVE To determine the effects of specialized shoes with insoles in patients with rheumatoid arthritis and the differences in terms of type of insole and anatomical location of foot pathology . DESIGN Single-blinded r and omized controlled trial . SETTING Out patients of physical medicine and rehabilitation clinic at university hospital . SUBJECTS Forty-two patients with rheumatoid foot lesions were r and omly assigned to two different orthotic intervention groups . The anatomical locations of the foot lesions were recorded ( hindfoot or forefoot ) . INTERVENTION Participants were provided with an extra deep forefoot-rockered shoe and either a custom-made semi-rigid insole or a ready-made simple soft insole . They wore the provided footwear for at least 3 hours a day over six months . MAIN OUTCOME MEASURES Primary outcome measures were foot pain visual analogue scale ( VAS ) scores and Foot Function Index ( FFI ) . Secondary outcome measures were erythrocyte sedimentation rate and C-reactive protein levels in blood , amounts of medications and active joint counts . These were checked at baseline and post intervention . RESULTS Eight patients dropped out at follow-up after six months of treatment . At six-month follow-ups , VAS scores and total Foot Function Index scores had decreased significantly in both groups versus baseline but intergroup comparison showed no significant differences in view of type of insoles and anatomical locations of foot pathology . CONCLUSIONS We were unable to identify differences between the types of insoles in terms of their clinical effects or between anatomical locations of foot lesions in the two groups , but both groups improved . Therapeutic shoes plus soft insoles might be effective enough in terms of foot pain and foot function for specific patients with rheumatoid foot problems regardless of the location of foot pathology",
"OBJECTIVE To evaluate the efficacy of custom foot orthoses for the management of painful rearfoot valgus in patients with rheumatoid arthritis ( RA ) . METHODS Patients were r and omized to receive custom-manufactured rigid carbon graphite foot orthoses ( RA-orthosis ) or enter a control group ( RA-control ) receiving no orthotic intervention . Three-dimensional ( 3D ) kinematics were measured at the ankle joint complex ( AJC ) using an electromagnetic tracking ( EMT ) system under barefoot , shod , and orthosis walking conditions . Previously established normal 3D kinematic data were used to descriptively compare motion patterns in both RA groups and statistical analyses were performed on integrals of motion-time for each axis of rotation from data collected at baseline , 3 , 6 , 12 , 18 , 24 , and 30 months . RESULTS Compared with healthy control subjects , all patients with RA demonstrated excessive subtalar joint eversion motion through the stance phase of gait ( p excessive internal leg rotation ( p orthoses significantly reduced eversion through stance ( p = 0.009 ) and re-established equilibrium of motion relative to neutral joint position . Correcting the frontal plane component of the deformity did not lead to a significant reduction in internal leg rotation ( p = 0.294 ) . The devices had no effect on tibiotalar dorsiflexion/plantarflexion ( p = 0.960 ) . Prospect ively , the rigid orthoses maintained and then improved the reduction in cumulative subtalar eversion motion ( p cumulative subtalar component eversion and internal leg rotation were recorded for both RA groups when walking barefoot but the effect was significantly less for the RA-control group . From 12 months onwards , internal leg rotation started to decrease , suggesting re-coupling of motion , but the overall motion pattern remained abnormal in comparison with normal reference values . CONCLUSION These results support the continuous use of custom-manufactured foot orthoses to correct deformity and optimize AJC function in RA patients with early painful deformity of the rearfoot",
"Hallux valgus deformity is the most commonly observed forefoot deformity in patients with rheumatoid arthritis . This 5-year , double-blind , r and omized clinical trial compared treatment orthoses with placebo orthoses for the prevention of hallux valgus deformity in the rheumatoid arthritic foot . One hundred and two subjects with active rheumatoid arthritis and with foot pain and minimal radiographic changes of the feet participated in the study . They were recruited from five arthritis clinics in the Chicago metropolitan area that are affiliated with or are teaching clinics of area medical schools . Patients were followed for 3 years . Eighty-one subjects completed the study . In a logistic regression analysis , the treatment group was 73 % less likely to develop hallux valgus deformity compared with the control group ( adjusted odds ratio 0.27 , 95 % confidence interval 0.078 , 0.916 p = .04 ) . These findings suggest that foot orthoses can prevent or slow the progression of hallux valgus deformity",
"OBJECTIVES Prescribing foot orthotics in rheumatoid arthritis patients with symptomatic forefoot involvement is a st and ard practice . However , limited research has been reported regarding gait and pain improvement with the use of foot orthotics . PATIENTS AND METHODS Sixteen patients ( 13 F , 3 M ; mean age : 52 + /- 12 years ) with metatarsalgia due to rheumatoid arthritis were included in this prospect i ve , r and omized with crossover study , and received foot orthotics . At 1 month follow-up , space and time gait variables with and without foot orthotics were assessed by Bessou 's locometer ; pain was assessed by visual analogue scale ( VAS ) . RESULTS Pain levels significantly decreased ( P = 0.008 ) by wearing foot orthotics . Despite a significant step length increase ( P = 0.05 ) with orthotics , there was no significant improvement of stride length , cadence , or walking speed which was the main assessment criterion . CONCLUSIONS Wearing foot orthotics improves pain , but not sufficiently to improve gait in rheumatoid arthritis patients with metatarsalgia . Foot orthotics improved comfort levels because of a decrease in pain , but was not sufficient to correct gait"
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CONTEXT Coronary heart disease ( CHD ) is responsible for about 15 % of all deaths worldwide and is identified as a top priority for decision makers . Both primary and secondary prevention are considered key strategies in the prevention of CHD . The aim of this study was to assess the efficacy of nonpharmacologic interventions with multiple lifestyle components in patients with established CHD in comparison to usual care . For this reason , a systematic review and meta- analysis of RCTs were performed . EVIDENCE ACQUISITION The Cochrane Library , MEDLINE , and EMBASE data bases were examined until March 31 , 2012 ( without start date ) in order to identify studies addressing patient-tailored multifactorial lifestyle interventions aim ed at reducing more than one cardiovascular risk factor in patients with established CHD . Primary endpoints were fatal and nonfatal cardiovascular events . Secondary outcomes were overall mortality and cardiovascular disease-associated hospital readmissions . EVIDENCE SYNTHESIS The search strategy yielded 14 unique RCTs , which were considered in the qualitative analysis . Nine of them contributed to the meta- analysis . A r and om effects model was used to pool the data . The meta- analysis showed a significant risk reduction of 18 % ( relative risk 0.82 , 95 % CI=0.69 , 0.98 ) of fatal cardiovascular events in patients undergoing multifactorial lifestyle interventions . Further , a nonsignificant reduction of nonfatal events , overall mortality and hospital readmissions was found . CONCLUSIONS Multifactorial lifestyle interventions aim ed at improving modifiable risk factors in patients with established CHD reduce the risk for fatal cardiovascular events . Therefore , they may have added value in secondary prevention of CHD
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"BACKGROUND Recent clinical trials have shown that modification of plasma lipoprotein concentrations can favorably alter progression of coronary atherosclerosis , but no data exist on the effects of a comprehensive program of risk reduction involving both changes in lifestyle and medications . This study tested the hypothesis that intensive multiple risk factor reduction over 4 years would significantly reduce the rate of progression of atherosclerosis in the coronary arteries of men and women compared with subjects r and omly assigned to the usual care of their physician . METHODS AND RESULTS Three hundred men ( n = 259 ) and women ( n = 41 ) ( mean age , 56 + /- 7.4 years ) with angiographically defined coronary atherosclerosis were r and omly assigned to usual care ( n = 155 ) or multifactor risk reduction ( n = 145 ) . Patients assigned to risk reduction were provided individualized programs involving a low-fat and -cholesterol diet , exercise , weight loss , smoking cessation , and medications to favorably alter lipoprotein profiles . Computer-assisted quantitative coronary arteriography was performed at baseline and after 4 years . The main angiographic outcome was the rate of change in the minimal diameter of diseased segments . All subjects underwent medical and risk factor evaluations at baseline and yearly for 4 years , and reasons for all hospitalizations and deaths were documented . Of the 300 subjects r and omized , 274 ( 91.3 % ) completed a follow-up arteriogram , and 246 ( 82 % ) had comparative measurements of segments with visible disease at baseline and follow-up . Intensive risk reduction result ed in highly significant improvements in various risk factors , including low-density lipoprotein cholesterol and apolipoprotein B ( both , 22 % ) , high-density lipoprotein cholesterol ( + 12 % ) , plasma triglycerides ( -20 % ) , body weight ( -4 % ) , exercise capacity ( + 20 % ) , and intake of dietary fat ( -24 % ) and cholesterol ( -40 % ) compared with relatively small changes in the usual-care group . No change was observed in lipoprotein(a ) in either group . The risk-reduction group showed a rate of narrowing of diseased coronary artery segments that was 47 % less than that for subjects in the usual-care group ( change in minimal diameter , -0.024 + /- 0.066 mm/y versus -0.045 + /- 0.073 mm/y ; P deaths occurred in each group . There were 25 hospitalizations in the risk-reduction group initiated by clinical cardiac events compared with 44 in the usual-care group ( rate ratio , 0.61 ; P = .05 ; 95 % confidence interval , 0.4 to 0.9 ) . CONCLUSIONS Intensive multifactor risk reduction conducted over 4 years favorably altered the rate of luminal narrowing in coronary arteries of men and women with coronary artery disease and decreased hospitalizations for clinical cardiac events",
"BACKGROUND Current guidelines broadly recommend comprehensive cardiac rehabilitation ( CR ) , although evidence for this is still limited . It is not known whether evidence from before 1995 is still valid . STUDY DESIGN The DANish Cardiac ReHABilitation ( DANREHAB ) trial was design ed as a central ly r and omized clinical trial to clarify whether hospital-based comprehensive CR is superior to usual care for patients with congestive heart failure , ischemic heart disease , or high risk for ischemic heart disease . A combined primary outcome measure included total mortality , myocardial infa rct ion , or readmissions due to heart disease based on linkage to public registries . The CR was an individually tailored , multidisciplinary program ( 6 weeks of intensive CR and 12 months of follow-up ) including patient education , exercise training , dietary counseling , smoking cessation , psychosocial support , risk factor management , and clinical assessment . STUDY POPULATION Of 5060 discharged patients , 1614 ( 32 % ) were eligible for the trial and 770 patients were r and omized ( 47 % of those eligible ) . Participants were younger ( P .001 ) and had less comorbidity than non participants ( P comprehensive CR can be conducted among a broadly defined patient group , but reaching the stipulated number of 1800 patients was difficult . Although the study included relatively many women and older people , elderly patients and patients with high comorbidity were underrepresented , which may influence the external validity",
"Résults are presented from the \" belgian heart disease prevention project , part of the WHO european collaborative trial in the multifactorial prevention of coronary heart disease ( CHD ) \" . 19.409 men aged 40 - 59 yr took part ; they were employed in thirty factories which formed the allocation units for a r and omised controlled trial lasting 5 - 6 yr . The intervention package consisted largely of health education promoting a cholesterol-lowering diet , smoking cessation , weight control , physical activity , and treatment of arterial hypertension . A programme of information was supplemented by face-to-face counselling at the workplace by two physicians attached to the project . The coronary risk profile was reduced in the intervention group , compared with that in the control group , especially during the first 4 yr , by effects on serum cholesterol , number of cigarettes smoked daily , and arterial blood-pressure . Total mortality was 17.5 % lower in the intervention group than in the control group ( p = 0.038 ) ; coronary mortality was reduced by a non-significant 20.8 % whereas CHD incidence ( non-fatal myocardial infa rct ion plus fatal myocardial infa rct ion plus sudden deaths ) was reduced by 24.5 % , ( P = 0.031 ) . Non-fatal myocardial infa rct ion ( not a major end-point ) was similarly reduced by 26.1 % ( p = 0.030 )",
"More than 1 million US citizens die of cerebral , cardiac , and peripheral vascular disease ( collectively , CVD ) each year . Basic science and clinical outcome research aim ed at reducing the burden of this illness is widespread , but the knowledge gleaned from controlled trials has not fully translated into everyday clinical practice and care of patients with CVD and their inherent risk factors . The Lowering of Vascular Atherosclerotic Risk ( LOVAR ) program was a 5-year observational study that evaluated the feasibility of a high-intensity multidisciplinary program of risk factor reduction in a population with known symptoms of CVD . The population comprised patients with documented clinical ly symptomatic cerebral , cardiac , or peripheral vascular disease and at least two modifiable risk factors for stroke , myocardial infa rct ion , or peripheral vascular occlusive disease . Final outcomes were evaluated by comparing primary and secondary end points and quality of life . A total of 271 patients were enrolled in the intervention group , and 242 were enrolled in the st and ard care group ( control ) . At 3 years , significant improvements in several risk factors were seen in the intervention group , with no significant improvements for the control group . The rate of patient retention was 95 % at 3 years , and overall rates of physician and patient satisfaction were high . We believe that the Lowering of Vascular Atherosclerotic Risk program is generalizable to a sufficiently motivated population targeted as high risk for vascular disease",
"Incidence and mortality results are presented from an international controlled trial of multifactorial prevention of coronary heart disease , involving r and omization of 66 factories ( 49 781 men ) in U.K. , Belgium , Italy and Pol and ( Cracow ) . Results for Pol and ( Warsaw ) are not yet complete . Net average reductions in risk factors ( all subjects ) were 1.2 % for plasma cholesterol , 8.9 % for daily cigarettes , 0.4 % for weight , 2.0 % for systolic blood pressure , and 11.1 % for a combined risk estimate . Greater reductions occurred in high-risk subjects ( 19.4 % for the combined estimate ) . The net overall reduction in CHD rates was 7.4 % ( 95 % confidence interval -29 to + 15 % ) for deaths ( 722 cases ) , and 3.9 % ( 95 % confidence interval -10 to + 2 % ) for fatal CHD + non-fatal myocardial infa rct ion ( 1502 cases ) . Among men aged 40 - 49 the reduction for this end-point was 15 % ; at ages 50 - 59 there was a small net increase . All-causes deaths after an early adverse trend showed 2.7 % reduction overall . There were large differences between centres , ranging from a 5 % net increase in CHD for U.K. to a decrease of 24 % in Belgium . In Belgium the decrease both in CHD and in all deaths was significant at the 5 % level . The effect on CHD in the different centres correlated broadly with their changes in risk factors . It is concluded that reduction in major coronary risk factors in industrial population s is possible , but it depends on adequate re sources ; the results support the hypotheses that CHD risk in middle-aged men is reversible and that community intervention can be beneficial",
"BACKGROUND It was the aim of this study to assess the long-term effects of physical exercise and low-fat diet on the progression of coronary artery disease . At the beginning of the study , 113 male patients with coronary artery disease were r and omized to an intervention group ( n=56 ) or a control group ( n=57 ) ; 90 patients ( 80 % ) could be reevaluated after 6 years . METHODS AND RESULTS Patients in the intervention group ( n=40 ) showed a reduction in total serum cholesterol ( 6.03+/-1.03 versus 5.67+/-1.01 mmol/L ; P triglyceride levels ( 1.94+/-0.8 versus 1.6+/-0.89 mmol/L ; P body mass index ( 26+/-2 versus 27+/-2 kg/m2 ; P = NS ) , but results were not statistically different from the control group ( n=50 ) ( total serum cholesterol , 6.05+/-1.02 versus 5.79+/-0.88 mmol/L ; triglycerides , 2.25+/-1.28 versus 1.85+/-0.96 mmol/L [ both P = NS ] ; body mass index , 26+/-2 versus 28+/-3 kg/m2 [ P physical work capacity ( 166+/-59 versus 212+/-89 W ; P stenoses progressed at a significantly slower rate than in the control group ( P Energy expenditure during exercise was assessed in a subgroup ; patients with regression of coronary stenoses spent an average of 1784+/-384 kcal/wk ( approximately 4 hours of moderate aerobic exercise per week ) . Multivariate regression analysis identified only physical work capacity as independently contributing to angiographic changes . CONCLUSIONS After 6 years of multifactorial risk intervention , there is significant and persistent improvement in lipoprotein levels and physical work capacity , which results in a significant retardation of disease progression . These beneficial effects appear to be largely due to chronic physical exercise",
"OBJECTIVES The authors examined clinical outcomes in 71 male and female patients with coronary atherosclerosis who enrolled in a 2-year , independent-living , lifestyle modification program . The findings in 43 patients who completed the program were compared with those in 28 patients who dropped out of the program . BACKGROUND Clinical studies suggest that lifestyle modification of risk factors for coronary atherosclerosis reduces subsequent cardiac events but there are very few reports of the effect of these programs in patients living independently . METHODS Patients with diagnosed coronary atherosclerosis were managed for a 2-year period in a structured multidisciplinary program by a team that included two cardiologists , a nurse , a dietitian , an exercise physiologist , and a clinical psychologist . The overall aim of the program was to normalize or control all major reversible cardiovascular risk factors . Patients were required to participate in several weekly sessions for exercise , meditation/stress reduction training , dietary education and counseling , and participatory dinners . There was a strong emphasis on patient 's self care , inclusion of support members , and regular monitoring of and feedback to patients . RESULTS Data comparing baseline and 2-year outcomes showed a significant reduction in body weight , dietary intake of total/saturated fat and cholesterol , serum low- and high-density lipoprotein concentration , and an increase in exercise capacity . In the compliant group , the incidence of cardiac events was 2.3 % over 2 years . CONCLUSION Multidisciplinary lifestyle modification programs addressing cardiovascular risk factors are known to have a significant impact upon cardiac risk factors in patients with coronary atherosclerosis . Data show that these changes can be accomplished in independent-living patients in a program offered through a routine cardiology service . However , compliance is an important issue in these self-regulated programs",
"The aim of the review was to assess the effect of patient education in ischaemic heart disease . Thirteen r and omised controlled trials of moderate to good quality including 68,556 patients were selected . The effect on mortality , cardiac morbidity , hospitalisation and health-related quality of life was assessed and only non-significant tendencies of effect were found . The authors of the review nevertheless conclude that the review supports current rehabilitation programmes that include patient education . Further research in patient education , especially concerning the most effective methods of education delivery , is needed",
"Background : Many studies have shown that individual lifestyle factors are associated with cardiovascular mortality and all-cause mortality . Observational studies of comprehensive programmes have reported risk reductions . The objectives were to assess the long-term all-cause mortality by diagnosis in patients referred to a lifestyle modification programme , aim ed at combating coronary heart disease and stroke . Methods : A r and omized trial with 325 patients referred to the centre between 1988 and 1989 for dyslipidemia , hypertension , type 2 diabetes and coronary heart disease ; 239 patients were r and omized to the programme , 86 r and omized to usual care . Cases were admitted to the centre in groups of 30 for a 4-week residential comprehensive activity , in total 114 full-time hours , focusing on food preferences and selection s , and physical exercise . The activities were repeated during a 4-day revisit to the centre 1 year and 5 years after the 4-week intervention . Controls were referred back to their doctors , mainly in primary care , for usual care . Main outcome measure was all-cause mortality during 11–12 and 18–19 years after intervention . Results : At follow-up 11–12 years after referral , the relative risk reduction ( RRR ) was 76 % with the intention-to-treat analysis among cases admitted for dyslipidemia ( hazards ratio 0.24 , confidence interval 0.06–0.89 , P = 0.033 ) . After 18–19 years , the RRR was 66 % ( hazards ratio 0.34 , confidence interval 0.13–0.88 , P = 0.026 ) . No RRR was found for the other three diagnoses . Conclusion : Patients admitted for dyslipidemia reached a real long-term RRR of all-cause mortality . They had by definition a need for this programme",
"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",
"Examination of comparable groups of patients with angina of efforts has demonstrated identical clinical efficiency of multi-factor therapeutic modalities and methods of instrumental physiotherapy for medical rehabilitation of patients with stable angina of effort . The results of this study suggest the possibility to avoid polypragmasia when prescribing physiotherapeutic treatment",
"AIMS The effectiveness of multifactorial cardiovascular disease prevention in patients aged 75 years or older is uncertain , because these patients have often been excluded from trials . The aim of this pre-planned , first-year analysis of the Drugs and Evidence -Based Medicine in the Elderly ( DEBATE ) Study was to determine the feasibility of prevention efforts in elderly cardiovascular patients . METHODS AND RESULTS For DEBATE , home-dwelling individuals aged 75 years and over with cardiovascular diseases ( n=400 , mean age 80 years , 65 % women ) were recruited from the community . These high-risk participants were r and omly assigned to the intervention group ( n=199 ) where both lifestyle modification and pharmacological cardiovascular treatments are individualized by a geriatrician according to current European guidelines . The control group ( n=201 ) receives the usual care . Interim analysis of the study groups at one year shows that intervention has succeeded in increasing the use of statins , aspirin , beta-blockers , and ACE inhibitors , and decreasing serum cholesterol ( p LDL-cholesterol ( p hsCRP ( p=0.04 ) . Body mass index , blood pressure , and blood glucose were similar at one year in both groups . No safety problems or adverse effects on health-related quality of life were observed and compliance was good . CONCLUSIONS It is possible and safe to institute evidence -based cardiovascular treatments in the 75 + cardiovascular patients in a real life setting , but only serum cholesterol and hsCRP are significantly decreased",
"AIMS In a multifactorial lifestyle behaviour programme , of 2 years duration , to study the maintenance of achieved behaviour and risk factor-related changes . METHODS AND RESULTS Out of a consecutive population of 151 patients treated with percutaneous transluminal angioplasty under 65 years of age , 87 were r and omly allocated to an intervention group ( n=46 ) or to a control group ( n=41 ) . The programme started with a 4 week residential stay , which was focused on health education and the achievement of behaviour change . During the first year of follow-up , a maintenance programme included regular contacts with a nurse , while no further rehabilitative efforts were offered during the second year . One patient died ( control ) . During the second year the proportion of hospitalized patients was lower in the intervention group ( 4 % vs 20%;P lifestyle dependent behaviours : diet ( index at 0 , 12 and 24 months ) : 10.5+/-3 . 4 , 12.9+/-2.5 and 12.4+/-2.6 in the intervention group ( I ) vs 10 . 1+/-3.2 , 10.7+/-3.0 and 11.8+/-3.2 in the control group (C);P exercise sessions per week : 2.5+/-2.3 , 4.5+/-1.9 and 4.4+/-2.1 ( I ) vs 3.1+/-2.2 , 3.5+/-2.3 and 3.7+/-2.7 (C);P smoking ; 18 % , 6 % and 9 % ( I ) vs 12 % , 21 % and 18 % (C);P exercise capacity ( 0 , 12 and 24 months ) : 156+/-42 , 174+/-49 and 165+/-47 W ( I ) vs 164+/-40 , 163+/-49 and 156+/-48 watts (C);P serum cholesterol levels at 0 and 24 months : 5 . 4+/-0.8 and 5.2+/-0.9 mmol . l(-1)(I ) vs 5.4+/-1.0 and 4.9+/-0.9 mmol . l(-1)(C ) ; ns , low density lipoprotein cholesterol level : 3.6+/-0.8 and 3.4+/-0.8 mmol . l(-1)(I ) vs 3.7+/-0.9 and 3.3+/-0.7 mmol . l(-1)(C ) ; ns , triglyceride level : 2.2+/-1.6 and 1.8+/-1.3 mmol . l(-1)(I ) vs 2.2+/-1.4 and 1.6+/-0.6 mmol . l(-1)(C ) ; ns , body mass index ( 0 , 12 and 24 months ) : 27.5+/-4.5 , 27.0+/-4.3 and 27.4+/- 4.5 kg . m(-2)(I ) vs 26.8+/-2.8 , 26.9+/-2.7 and 26.9+/- 3.2 kg . m(-2)(C ) ; ns , waist/hip ratio or blood pressure . The two groups did not differ in quality of life , or psychological factors . Return to work after 12 and 24 months was 74 % and 78 % ( I ) vs 68 % and 61 % ( C ) ; ns . CONCLUSION This rehabilitation programme influenced important lifestyle behaviour and reduced some , but not all , important risk",
"BACKGROUND AND OBJECTIVE In spite of publication of many guidelines , management of patients on secondary prevention of cardiovascular disease is still not appropriated . We design a r and omized trial , in usual clinical practice conditions , to compare the results in cardiovascular morbimortality of intensive and integral management of cardiovascular risk factors ( CVRF ) management versus conventional care . PATIENTS AND METHOD We selected patients discharged between October 2002 and January 2004 who suffered an acute coronary syndrome with or without ST-segment elevation or a stroke , 247 patients that met inclusion s criteria were r and omized to intensive care of CVRF in a specific Internal Medicine outpatient clinic ( n = 121 ) or usual care according to National Health Service recommendations ( n = 126 ) . A year after r and omization , the percentage of patients who met CVRF control , treatment received and the number of cardiovascular events ( cardiovascular death , acute coronary syndrome with or without ST-segment elevation , stroke , transient ischemic attack , revascularization , lower limb amputation , heart failure admission and sudden death ) were revised . RESULTS CVRF control was greater in patients assigned to intensive care . 74.1 % of hypertensive patients assigned to this treatment were controlled vs 41.7 % in the usual care group ( relative risk [ RR ] = 1.78 ; 95 % confidence interval [ CI ] , 1.27 - 2 - 49 ) ; 70.2 % of patients had low-densi-tiy lipoprotein cholesterol lower than 100 mg/dl vs 55.8 % ( RR = 1.26 ; 95 % CI , 1.00 - 1.58 ) of patients in usual care group ; 93.1 % of diabetic patients had glycosylated haemoglobin lower than 7 % vs. 57.1 % ( RR = 1.63 ; 95 % CI , 1.11 - 2.39 ) in the usual care group . There were 12 cardiovascular events in the intensive care group vs 35 in the usual care group . CONCLUSIONS Intensive management of CVRF leads to a better control of them and a reduction of the morbimortality one year after an acute cardiovascular event",
"The aim of this study was to compare the effects of residential multifactorial cardiac rehabilitation , outpatient multifactorial rehabilitation , stress management , and st and ard coronary rehabilitation , on cardiac risk reduction . Out of 144 eligible male patients recently treated with percantaneous transluminal coronary angiography ( PTCA ) , coronary artery bypass graft ( CABG ) , or acute myocardial infa rct ion ( AMI ) , 132 were r and omized into this study . All interventions covered a 12-month active intervention , intense during the first months and subsequently leveled out . Main assessment s were performed before r and omization and after the intervention . Patients offered behavioral rehabilitation showed improved selfreported healthy diet habits and exercise frequency , and higher internal locus of control . Although blood lipids , exercise capacity , body mass , anxiety , depression , and Type A scores were changed in the expected direction , no significant difference emerged between active intervention and the st and ard care condition . St and ard care of today appears to have great potential in particular if supplemented with some kind of stress management",
"Abstract BACKGROUND : Integrative medicine is an individualized , patient-centered approach to health , combining a whole-person model with evidence -based medicine . Interventions based in integrative medicine theory have not been tested as cardiovascular risk-reduction strategies . Our objective was to determine whether personalized health planning ( PHP ) , an intervention based on the theories and principles underlying integrative medicine , reduces 10-year risk of coronary heart disease ( CHD ) . METHODS : We conducted a r and omized , controlled trial among 154 out patients age 45 or over , with 1 or more known cardiovascular risk factors . Subjects were enrolled from primary care practice s near an academic medical center , and the intervention was delivered at a university Center for Integrative Medicine . Following a health risk assessment , each subject in the intervention arm worked with a health coach and a medical provider to construct a personalized health plan . The plan identified specific health behaviors important for each subject to modify ; the choice of behaviors was driven both by cardiovascular risk reduction and the interests of each individual subject . The coach then assisted each subject in implementing her/his health plan . Techniques used in implementation included mindfulness meditation , relaxation training , stress management , motivational techniques , and health education and coaching . Subjects r and omized to the comparison group received usual care ( UC ) without access to the intervention . Our primary outcome measure was 10-year risk of CHD , as measured by a st and ard Framingham risk score , and assessed at baseline , 5 , and 10 months . Differences between arms were assessed by linear mixed effects modeling , with time and study arm as independent variables . RESULTS : Baseline 10-year risk of CHD was 11.1 % for subjects r and omized to UC ( n=77 ) , and 9.3 % for subjects r and omized to PHP ( n=77 ) . Over 10 months of the intervention , CHD risk decreased to 9.8 % for UC subjects and 7.8 % for intervention subjects . Based on a linear mixed-effects model , there was a statistically significant difference in the rate of risk improvement between the 2 arms ( P=.04 ) . In secondary analyses , subjects in the PHP arm were found to have increased days of exercise per week compared with UC ( 3.7 vs 2.4 , P=.002 ) , and subjects who were overweight on entry into the study had greater weight loss in the PHP arm compared with UC ( P=.06 ) . CONCLUSIONS : A multidimensional intervention based on integrative medicine principles reduced risk of CHD , possibly by increasing exercise and improving weight loss ",
"BACKGROUND Current guidelines broadly recommend comprehensive cardiac rehabilitation ( CCR ) , although evidence for this is still limited . We investigated the 12-month effect of hospital-based CCR versus usual care ( UC ) for a broadly defined group of cardiac patients within the modern therapeutic era of cardiology . METHODS We conducted a central ly r and omized single-center clinical trial with blinded assessment of the primary outcome : registry-based composite of total mortality , myocardial infa rct ion , or acute first-time readmission due to heart disease . Other outcomes were hospitalization , risk profile , and quality of life . The trial included 770 participants ( 20 - 94 years ) with congestive heart failure ( 12 % ) , ischemic heart disease ( 58 % ) , or high risk of ischemic heart disease ( 30 % ) . Comprehensive cardiac rehabilitation is composed of 6 weeks of intensive intervention and systematic follow-up for 10.5 months . RESULTS We r and omized 380 patients to CCR versus 390 to UC . R and omization was well balanced . The primary outcome occurred in 31 % of both groups ( relative risk 0.96 , 95 % confidence interval 0.78 - 1.26 ) . Compared with the UC group , CCR significantly reduced length of stay by 15 % ( 95 % confidence interval 1.1%-27.1 % , P = .04 ) , mean number of cardiac risk factors above target ( 4.5 vs 4.1 , P = .01 ) , patients with systolic blood pressure below target ( P = .003 ) , physically inactivity ( P = .01 ) , and unhealthy dietary habits ( P = .0003 ) . Short-Form-36 and Hospital Anxiety and Depression Scale did not differ significantly . CONCLUSION At 12 months , the CCR and UC groups did not differ regarding the primary composite outcome . Comprehensive cardiac rehabilitation significantly reduced length of hospital stay and improved cardiac risk factors",
"The Belgian Heart Disease Prevention Project was a controlled , r and omized multifactorial intervention trial in middle-aged men which lasted 6 years . Significant net differences between intervention and control groups were observed in change in risk profile , in total mortality and in CHD incidence . The net difference in risk profile change was greatest at two years , intermediate at four years and minimal at six years . Total and cause-specific mortality rates were systematic ally followed from the 6th to the 10th year . Follow-up at 10 years was 99.3 % complete . The differences between intervention and control groups in total , coronary and cardiovascular mortality reduced from the 6th to the 10th year . The results suggest that changes in risk profile are rapidly followed by changes in cardiovascular mortality , but this applies in both directions . Thus risk reduction should be maintained in order to achieve a long-lasting preventive effect",
"Objective : To investigate the effects of exp and ed cardiac rehabilitation with multifactorial interventions on metabolic and inflammatory markers , exercise performance and on established cardiovascular risk factors . Design : Single-centre prospect i ve r and omized controlled trial . Setting : A university hospital . Subjects : Two hundred and twenty-four patients with an acute myocardial infa rct ion or patients undergoing coronary artery by-pass grafting . Intervention : Patients were r and omized to exp and ed cardiac rehabilitation including stress management , increased physical training , staying at a ' patient hotel ' and cooking sessions , or to usual cardiac rehabilitation Main measures : Biochemical risk markers and exercise performance ; follow-up was one year . Results : There were no significant differences between the two treatment groups in the changes of biochemical risk markers or in exercise performance . Thus , low-density lipoprotein (LDL)-cholesterol levels decreased from 3.00 ( 0.97 ) to 2.54 ( 0.66 ) mmol/L in the intervention group and from 3.20 ( 0.85 ) to 2.54 ( 0.63 ) mmol/L in the control group , fibrinogen levels decreased from 5.30 ( 2.00 ) to 4.25 ( 1.01 ) g/L in the intervention group and from 5.29 ( 1.89 ) to 4.33 ( 0.83 ) g/L in the control group and C-reactive protein ( CRP ) levels decreased from 3.04 ( 2.79 ) to 2.09 ( 2.13 ) mg/L in the intervention group and from 4.01 ( 3.49 ) to 2.39 ( 2.49 ) mg/L in the control group . Total workload ( W ) improved from 118 ( 35 ) to 136 ( 34 ) in the intervention group and from 117 ( 36 ) to 133 ( 39 ) in the control group . Conclusion : There was no further significant benefit in biochemical risk markers or in exercise performance among patients undergoing the exp and ed rehabilitation as compared to the control group which received usual cardiac rehabilitation",
"OBJECTIVE The effects of a short intervention on behavioral risk factor modification in patients with coronary artery disease ( CAD ) on Type A behavior , vital exhaustion , and depression were studied in a r and omized controlled trial . METHODS Acute myocardial infa rct ion patients or patients who underwent coronary artery bypass grafting ( CABG ) were r and omly assigned to an 8-week multiple risk modification group program ( n = 94 ) or to a control group ( n = 90 ) that received usual care with st and ard physical exercise training . Patients were assessed before intervention , directly after intervention , and at 9-month follow-up . RESULTS The intervention was effective in reducing hostility and total Type A behavior at postintervention ( P = .01 ) and at 9-month follow-up ( P = .03 ) . The intervention had no overall impact on vital exhaustion and depression , measured by the Beck Depression Inventory ( BDI ) , whereas we unexpectedly found that the percentage of patients with major depression was reduced in the control group but not in the intervention group . CONCLUSION The results indicate that a short behavioral intervention for coronary patients can result in relatively large and persistent reductions in cognitive aspects of Type A behavior and hostility , in particular . In view of the unwanted findings on the diagnosis of depression , however , we do not unequivocally advise the intervention to the general population of AMI and CABG patients",
"BACKGROUND The development of effective obesity interventions to reduce adiposity indicators in Latina girls is a public health priority because of their increased risk for becoming overweight . Research indicates that the summer season may be a critical time to intervene because summer exacerbates children 's risk for excessive weight gain and increased body fat development . PURPOSE The purpose of this study was twofold : ( 1 ) to determine if summer and follow-up interventions reduce adiposity in Latina girls ; ( 2 ) to assess if such interventions reduce adiposity in Latina girls after controlling for their mothers ' adiposity measures . DESIGN This study had a non-experimental ( one-group pre- and multiple post-intervention assessment ) design . Following a 4-week healthy-lifestyle summer program , each mother-daughter pair participated in 12 weekly follow-up sessions . SETTING / PARTICIPANTS The sample consisted of 61 pairs of Latina girls and their mothers ( N=122 ) . Daughters ' average age was 10.9 years ( ± 1.6 years ) and mothers ' average age was 38.0 years ( ± 1.6 years ) . All daughters and 92 % of the mothers were categorized as overweight/obese . MAIN OUTCOME MEASURES Percent body fat ( % BF ) , abdominal fat , and height and weight measurements to calculate BMI were conducted at pre-intervention ( M1 [ baseline ] ) and three post-intervention time points ( M2 [ Month 2 ] ; M3 [ Month 3 ] ; and M4 [ Month 6 ] ) . Paired sample t-tests were used to assess the differences in adiposity among the daughters from M1 to M4 . Repeated- measures ANCOVA tests were used to control for mother 's adiposity . RESULTS Reductions of % BF ( p ) ; abdominal fat ( p ) ; and BMI ( p for the summer intervention , but no effects were found at M4 . Maternal % BF , abdominal fat , and BMI did not have an impact on the daughters ' adiposity indicators . CONCLUSIONS Results from this study revealed that a summer intervention appears to be effective in reducing adiposity in Latina girls , but the follow-up sessions did not result in sustaining continued reductions . Maternal measures did not influence their daughters ' adiposity measures",
"This study examined whether nurses could manage coronary risk factors in patients with unstable angina more effectively than physicians practicing usual care . Three hundred twenty-six patients were r and omized in the emergency room to a 6-month program of risk factor management by a registered nurse versus participation in usual care . The nurse intervention consisted of a 30-minute counseling visit at 6 to 10 days after the chest pain episode and a second 30-minute session 1 month later . Multiple risk factors were assessed and addressed : smoking , blood lipids , blood pressure , blood glucose , physical inactivity , weight , psychological stress , and social isolation . Compared with usual care , nurse intervention patients significantly reduced both triglycerides ( -29 + /- 8 vs 5 + /- 6 mg/dl ; p weight ( -0.9 + /- 3.3 vs + 0.1 + /- 2.1 kg ; p = 0.0071 ) , and had corresponding improvements in self-reported diet compliance and exercise ( + 34 + /- 106 vs + 9 + /- 98 minutes , p = 0.0491 ) . No significant differences between groups were observed in terms of 6-month changes in total , high-density lipoprotein , or low-density lipoprotein cholesterol , blood pressure , fasting blood glucose , percent body fat or waist-hip ratio , or psychological distress scores . The 6-month rate of recurrent events ( cardiac death , out-of-hospital cardiac arrest , myocardial infa rct ion ) and /or revascularizations ( coronary artery bypass surgery or coronary angioplasty ) was lower in the nurse intervention group ( 1 % vs 9 % ; p = 0.002 ) . We conclude that a nurse-delivered risk factor intervention program for patients with chest pain is feasible and more effective than usual care in terms of fostering lifestyle changes that may lower coronary risk",
"Participation in a st and ard-length outpatient cardiac rehabilitation program ( CRP ) for 3 months is known to result in positive changes in body composition , functional capacity , and blood lipids in patients with coronary artery disease . However , there has been little attempt to compare patients who remain active in a formal CRP for an extended length of > 1 year with patients who exit after a st and ard length of 3 months . Consequently , 50 patients underwent a series of tests including a maximal grade d exercise treadmill test , assessment of body composition , and fasting blood lipid analysis , at entry to CRP and after a follow-up period that ranged from 1 to 5 years . All patients participated in a st and ard multidisciplinary cardiac rehabilitation program for 3 months . Twenty-five patients discontinued participation after 3 months and received no other contact from the program staff until follow-up , whereas 25 patients remained active in the program until follow-up . After statistically adjusting for baseline differences between the groups , significant differences were observed between the extended- and st and ard-length groups at follow-up for body weight ( 177 vs 183 lbs ) , percent fat ( 22 % vs 24 % ) , METS ( 10.5 vs 8.4 ) , high-density lipoprotein level cholesterol ( 44 vs 39 mg/dl ) , total cholesterol/high-density lipoprotein ratio ( 5.2 vs 6.1 ) , and triglycerides ( 134 vs 204 mg/dl ) , respectively . No significant differences in the adjusted means were observed between the groups at follow-up for total cholesterol ( 209 vs 219 mg/dl ) and low-density lipoprotein cholesterol ( 136 vs 138 mg/dl ) . Data from this study demonstrate the efficacy of extended participation in CRP on body composition , functional capacity , and blood lipids . Greater efforts need to be directed at retaining patients in low-cost , center-based maintenance programs and at extending monitoring of patients exiting st and ard length CRPs",
"Summary All male inhabitants of the city of Göteborg , who were born between 1915–1922 and 1924–1925 were included in the trial , and were 47 to 55 years of age on entry to the study in 1970 to 1973 . One-third of these men were r and omly allocated to an intervention group , whilst the other two-thirds acted as controls . Men of all social classes , employed as wellas unemployed , health conscious as well as careless , were invited , with 75 % of these responding to the invitation . The intervention group contained 10,000 men and the control group 20,000 men . The intervention group were given advice on diet , both individually and in groups , the type of advice depending upon serum cholesterol level . Smokers were advised to stop smoking , and men with elevated blood pressure were treated with antihypertensive drugs . Due to the large size of the groups and because they formed a r and om population sample , it was assumed that they had similar characteristics at the start of the trial . Risk factors were only measured in the intervention group at this time , followed by intervention . This design feature solved several ethical problems with regard to no treatment in the control group . These men were , however , subjected to health examinations and treatment as well as general health advice . Risk factor levels were measured in the intervention group , and also in r and om sub sample s ( 11 % ) of the control group after 4 and 10 years . Serum cholesterol , blood pressure and smoking decreased among men in both groups , and only slightly more in the intervention group . Antihypertensive drug treatment was given to 26 % of the intervention group and 20 % of the control group participants after 10 years . No significant effect on total or cardiovascular mortality , or on the incidence of myocardial infa rct ion or stroke was found . However , the effect of this intensive antihypertensive treatment on mortality and morbidity is indicated when the present results are compared to those of a previous population study in the same city . A markedly higher mortality in the group of non- participants diluted the results considerably , and some characteristics of this group will be discussed in view of future possibilities of prevention efforts in the whole community",
"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",
"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",
"The aim of the study was to evaluate a multifactorial rehabilitation programme based on interdisciplinary caring efforts for myocardial infa rct ion ( MI ) patients . R and omly chosen MI- patients participated , either in a six-month rehabilitation programme ( intervention group = 53 ) or in routine cardiac follow-ups ( control group = 63 ) . Subjective and objective instruments were used for measuring their health recovery . Biophysical improvements were showed as an increased physical capacity ( p less than 0.001 ) using a submaximal exercise test six months after MI , and less reinfa rct ions ( p less than 0.024 ) twelve months after MI , to the intervention patients ' advantage . Psychological improvements were demonstrated in a higher life satisfaction ( p less than 0.001 ) six months and ( 0.1 greater than p greater than 0.05 ) twelve months after MI to the intervention patients ' advantage . Social improvements were indicated as a better leisure situation ( p less than 0.004 ) six months after MI , and as a better partner situation ( p less than 0.010 ) , including a less influenced sex life ( p less than 0.017 ) , twelve months after MI to the intervention patients ' advantage . As to the overall view , the caring rehabilitation programme appeared to be required for the MI- patients ' health recovery . In order to be able to reach an optimal state of human health , an even more individualised programme seems to be necessary",
"BACKGROUND The number of patients aged 75 + years with cardiovascular diseases ( CVD ) is increasing , but few studies of secondary prevention in this age group exist . The aim of the Drug and Evidence Based Medicine in the Elderly ( DEBATE ) study is to test the applicability and effectiveness of established CVD treatments in elderly patients . METHODS From 1998 to 2000 , population -based postal surveys were performed in Helsinki , Finl and , including the age groups 75 , 80 , 85 , 90 , and 95 years ( n = 4821 ) . Of the 812 individuals reporting any atherosclerotic disease , 400 patients ( 66 % of those eligible ) were included in a r and omized trial . In the intervention group , CVD treatments will be individualized according to current guidelines . A control group will receive the usual care . The trial period will last 2 years with a 3-year extension . The primary end point will be a composite of major CVD . In addition , a number of secondary end points will be recorded , including permanent institutionalization , decline in cognitive and physical function , and quality of life . RESULTS During 2000 , 400 home-dwelling patients were r and omized to the intervention ( n = 199 ) and control ( n = 201 ) groups . The mean age is 80.2 years and 65.3 % are women . Of the participants , 82 % have coronary heart disease ( 41 % with history of myocardial infa rct ion ) , 37 % history of stroke , 19 % non-insulin-dependent diabetes mellitus , and 45 % hypertension , and 6 % are current smokers . Before r and omization , 67 % used aspirin , 40 % b-blockers , 14 % angiotensin-converting enzyme inhibitors , 36 % nitrates , and 20 % lipid-lowering drugs . The groups were well balanced at baseline . CONCLUSION We have successfully r and omized elderly patients with a high degree of comorbidity into a multifactorial CVD prevention trial",
"Background Cardiac rehabilitation programmes are a proven treatment for individuals with recent myocardial infa rct ion , result ing in reduced morbidity and mortality compared to usual care . Unfortunately , following completion of a cardiac rehabilitation programme , risk factors and lifestyle behaviours may deteriorate . The GlObal Secondary Prevention strategiEs to Limit event recurrence after myocardial infa rct ion ( GOSPEL ) study investigates the benefits of a programme of continued educational and behavioural interventions to achieve optimal long-term secondary prevention goals . Design This will be a multicentre , r and omized , controlled study carried out in 78 Italian cardiac rehabilitation centres . Methods After completion of an initial cardiac rehabilitation programme , patients with recent ( were r and omized to either a long-lasting ( over 3 years ) multifactorial continued educational and behavioural programme ( intensive approach ) or usual care ( control ) group . Intensive approach patients participated in extensive cardiac rehabilitation sessions , monthly from months 1 to 6 , then every 6 months for 3 years . Each session consisted of aerobic exercise , comprehensive lifestyle and risk factor counselling , and clinical assessment Usual care patients returned to their family physicians ’ care , and attended the reference centre only for the 6-month and then annual scheduled assessment . The efficacy of the two different strategies will be evaluated in terms of morbidity and mortality as primary endpoint . Results From January 2001 through December 2002 , 3241 patients were enrolled . Results will be available in mid 2006 . Conclusions The GOSPEL trial , the rationale and design of which we present here , was design ed to test a new strategy of secondary prevention delivery and to raise st and ards of long-term secondary prevention in Italy . With a cohort of over 3200 patients , GOSPEL is the largest r and omized , multifactorial lifestyle and risk factor intervention trial after myocardial infa rct ion conducted so far",
"AIM Previous studies have reported lifestyle and risk factor deterioration following completion of a cardiac rehabilitation program ( CRP ) . We report the results of a one-year Extensive Lifestyle Management Intervention ( ELMI ) aim ed at preventing these adverse changes . METHODS AND RESULTS A total of 302 men and women with ischaemic heart disease were recruited following completion of a CRP and r and omized to either the ELMI ( consisting of exercise sessions , telephone follow-ups and risk factor and lifestyle counselling ) or usual care . The primary outcome was global cardiovascular risk using the Framingham and Procam risk scores . Secondary outcomes included risk factors and lifestyle behaviours . Baseline characteristics were similar between the two groups . Adherence to the ELMI was high . There was a non-significant trend in favour of the ELMI between for both the Framingham ( 6.6+/-3.1 to 6.2+/-2.9 vs 6.6+/-3.2 to 6.7+/-3.2 , P=0.138 ) and Procam ( 20.0+/-20.0 to 20.6+/-19.5 vs 19.1+/-18.7 to 21.8+/-19.1 , P=0.089 ) scores . There were no differences in secondary outcomes . CONCLUSIONS A one-year multi-factorial post-CRP intervention results in modest , non-significant benefits to global risk compared to usual care . The absence of deterioration in the usual care group may be due to improved practice s in usual care",
"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 Data on the long-term benefits of nonspecific disease management programs are limited . We performed a long-term follow-up of a previously published r and omized trial . METHODS We compared all-cause mortality and recurrent hospitalization during median follow-up of 7.5 years in a heterogeneous cohort of patients with chronic illness initially exposed to a multidisciplinary , home-based intervention ( HBI ) ( n = 260 ) or to usual postdischarge care ( n = 268 ) . RESULTS During follow-up , HBI had no impact on all-cause mortality ( relative risk , 1.04 ; 95 % confidence interval , 0.80 - 1.35 ) or event-free survival from death or unplanned hospitalization ( relative risk , 1.03 ; 95 % confidence interval , 0.86 - 1.24 ) . Initial analysis suggested that HBI had only a marginal impact in reducing unplanned hospitalization , with 677 readmissions vs 824 for the usual care group ( mean + /- SD rate , 0.72 + /- 0.96 vs 0.84 + /- 1.20 readmissions/patient per year ; P = .08 ) . When accounting for increased hospital activity in HBI patients with chronic obstructive pulmonary disease during follow-up for 2 years , post hoc analyses showed that HBI reduced readmissions by 14 % within 2 years in patients without this condition ( mean + /- SD rate , 0.54 + /- 0.72 vs 0.63 + /- 0.88 readmission/patient per year ; P = .04 ) and by 21 % in all surviving patients within 3 to 8 years ( mean + /- SD rate , 0.64 + /- 1.26 vs 0.81 + /- 1.61 readmissions/patient per year ; P = .03 ) . Overall , recurrent hospital costs were significantly lower ( 14 % ) in the HBI group ( mean + /- SD , 823 dollars + /- 1642 dollars vs 960 dollars + /- 1376 dollars per patient per year ; P = .045 ) . CONCLUSION This unique study suggests that a nonspecific HBI provides long-term cost benefits in a range of chronic illnesses , except for chronic obstructive pulmonary disease",
"In a r and omised controlled evaluation of multifactorial prevention of coronary heart disease ( CHD ) among 60 881 men employed in 80 factories in Belgium , Italy , Pol and , and the UK intervention was associated with reductions of 10.2 % in total CHD , 6.9 % in fatal CHD , 14.8 % in non-fatal myocardial infa rct ion , and 5.3 % in total deaths , with a neutral result for non-CHD deaths . Benefit was significantly related to the extent of risk factor change . The observed reduction in total CHD was 62 % of that predicted by means of a multiple logistic function summary of risk factor changes . Advice on risk factor reduction in middle-aged men is effective to the extent that it is accepted and it appears to be safe",
"OBJECTIVE We aim ed to examine whether better use of preventive methods and treatments of cardiovascular disease would reduce recurrent events in home-dwelling patients 75 years or older . METHODS This was a r and omized , controlled trial ( a practical clinical trial , the DEBATE ) , conducted in 2000 to 2003 in Helsinki , Finl and . We recruited 400 vascular patients with mean age of 80 years from the community , and they were r and omly assigned to the intervention group ( n = 199 ) where both nonpharmacological and pharmacological cardiovascular treatments were optimized by a geriatrician according to current guidelines . The control group ( n = 201 ) received the usual care . Main outcome measures were major cardiovascular disease events and total mortality and changes in risk factors and medications . RESULTS The groups were balanced at baseline . Mean duration of follow-up was 3.4 years . At 3 years , drug treatments had become more evidence -based in the intervention group . Consequently , total and low-density lipoprotein cholesterol levels ( P systolic ( P = .005 ) and diastolic ( P = .009 ) blood pressure were significantly improved in the intervention group . However , neither primary end points ( 52 and 53 events in the intervention and control groups , respectively ) nor total mortality ( 36 and 35 deaths ) were significantly different between the two groups . No special adverse effects were encountered . CONCLUSION It was possible and safe to institute evidence -based cardiovascular treatments and improve risk factors in patients 75 years or older in a pragmatic setting . During 3.4 years , however , this was not converted to clinical benefits",
"375 consecutive patients below 65 years who had an acute myocardial infa rct ion ( AMI ) took part in a r and omised rehabilitation and secondary prevention trial ( part of a W.H.O.-coordinated project ) design ed to study the effects of a multifactorial intervention programme on morbidity , mortality , return to work , & c. After three years ' follow-up the cumulative coronary mortality was significantly smaller in the intervention group than in the controls ( 18.6 % versus 29.4 % , p = 0.02 ) . This difference was mainly due to a reduction of sudden deaths in the intervention group ( 5.8 % versus 14.4 % , p less than 0.01 ) . The reduction was greatest during the first six months after AMI . 18.1 % in the intervention group and 11.2 % in the controls ( p less than 0.10 ) presented with non-fatal reinfa rct ions . The number of patients with new Q-QS findings at the end of the three years was , however , almost the same in both groups . The results suggest that organised aftercare during the first six months after AMI with special emphasis on optimum medical control and health education contributes significantly to a reduction in the number of sudden deaths"
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Fructose-containing sugars are a focus of attention as a public health target for their putative role in obesity and cardiometabolic disease including diabetes . The fructose moiety is singled out to be the primary driver for the harms of sugars due to its unique endocrine signal and pathophysiological role . However , this is only supported by ecological studies , animal models of overfeeding and select human intervention studies with supraphysiological doses or lack of control for energy . The highest level of evidence from systematic review s and meta-analyses of controlled trials has not shown that fructose-containing sugars behave any differently from other forms of digestible carbohydrates . Fructose-containing sugars can only lead to weight gain and other unintended harms on cardiometabolic risk factors insofar as the excess calories they provide . Prospect i ve cohort studies , which provide the strongest observational evidence , have shown an association between fructose-containing sugars and cardiometabolic risk including weight gain , cardiovascular disease outcomes and diabetes only when restricted to sugar-sweetened beverages and not for sugars from other sources . In fact , sugar-sweetened beverages are a marker of an unhealthy lifestyle and their drinkers consume more calories , exercise less , smoke more and have a poor dietary pattern . The potential for overconsumption of sugars in the form of sugary foods and drinks makes targeting sugars , as a source of excess calories , a prudent strategy . However , sugar content should not be the sole determinant of a healthy diet . There are many other factors in the diet — some providing excess calories while others provide beneficial nutrients . Rather than just focusing on one energy source , we should consider the whole diet for health benefits
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"Background — Sugar-sweetened beverage consumption is associated with weight gain and risk of type 2 diabetes mellitus . Few studies have tested for a relationship with coronary heart disease ( CHD ) or intermediate biomarkers . The role of artificially sweetened beverages is also unclear . Methods and Results — We performed an analysis of the Health Professionals Follow-Up Study , a prospect i ve cohort study including 42 883 men . Associations of cumulatively averaged sugar-sweetened ( eg , sodas ) and artificially sweetened ( eg , diet sodas ) beverage intake with incident fatal and nonfatal CHD ( myocardial infa rct ion ) were examined with proportional hazard models . There were 3683 CHD cases over 22 years of follow-up . Participants in the top quartile of sugar-sweetened beverage intake had a 20 % higher relative risk of CHD than those in the bottom quartile ( relative risk=1.20 ; 95 % confidence interval , 1.09–1.33 ; P for trend Artificially sweetened beverage consumption was not significantly associated with CHD ( multivariate relative risk=1.02 ; 95 % confidence interval , 0.93–1.12 ; P for trend=0.28 ) . Adjustment for self-reported high cholesterol , high triglycerides , high blood pressure , and diagnosed type 2 diabetes mellitus slightly attenuated these associations . Intake of sugar-sweetened but not artificially sweetened beverages was significantly associated with increased plasma triglycerides , C-reactive protein , interleukin-6 , and tumor necrosis factor receptors 1 and 2 and decreased high-density lipoprotein , lipoprotein(a ) , and leptin ( P sugar-sweetened beverages was associated with increased risk of CHD and some adverse changes in lipids , inflammatory factors , and leptin . Artificially sweetened beverage intake was not associated with CHD risk or biomarkers",
"BACKGROUND Little is known about the effects of the amount and type of carbohydrates on risk of coronary heart disease ( CHD ) . OBJECTIVE The objective of this study was to prospect ively evaluate the relations of the amount and type of carbohydrates with risk of CHD . DESIGN A cohort of 75521 women aged 38 - 63 y with no previous diagnosis of diabetes mellitus , myocardial infa rct ion , angina , stroke , or other cardiovascular diseases in 1984 was followed for 10 y. Each participant 's dietary glycemic load was calculated as a function of glycemic index , carbohydrate content , and frequency of intake of individual foods reported on a vali date d food-frequency question naire at baseline . All dietary variables were up date d in 1986 and 1990 . RESULTS During 10 y of follow-up ( 729472 person-years ) , 761 cases of CHD ( 208 fatal and 553 nonfatal ) were documented . Dietary glycemic load was directly associated with risk of CHD after adjustment for age , smoking status , total energy intake , and other coronary disease risk factors . The relative risks from the lowest to highest quintiles of glycemic load were 1.00 , 1.01 , 1 . 25 , 1.51 , and 1.98 ( 95 % CI : 1.41 , 2.77 for the highest quintile ; P for trend of CHD risk . The association between dietary glycemic load and CHD risk was most evident among women with body weights above average ¿ ie , body mass index ( in kg/m(2 ) ) > /= 23 . CONCLUSION These epidemiologic data suggest that a high dietary glycemic load from refined carbohydrates increases the risk of CHD , independent of known coronary disease risk factors",
"BACKGROUND During the nutrition transition in Chile , dietary changes were marked by increased consumption of high-energy , nutrient-poor products , including sugar-sweetened beverages ( SSBs ) . Obesity is now the primary nutritional problem in posttransitional Chile . OBJECTIVE We conducted a r and omized controlled trial to examine the effects on body composition of delivering milk beverages to the homes of overweight and obese children to displace SSBs . DESIGN We r and omly assigned 98 children aged 8 - 10 y who regularly consumed SSBs to intervention and control groups . During a 16-wk intervention , children were instructed to drink 3 servings/d ( approximately 200 g per serving ) of the milk delivered to their homes and to not consume SSBs . Body composition was measured by dual-energy X-ray absorptiometry . Data were analyzed by multiple regression analysis according to the intention-to-treat principle . RESULTS For the intervention group , milk consumption increased by a mean ( + /- SEM ) of 452.5 + /- 37.7 g/d ( P consumption of SSBs decreased by -711.0 + /- 33.7 g/d ( P milk consumption did not change , and consumption of SSBs increased by 71.9 + /- 33.6 g/d ( P = 0.04 ) . Changes in percentage body fat , the primary endpoint , did not differ between groups . Nevertheless , the mean ( + /- SE ) accretion of lean body mass was greater ( P = 0.04 ) in the intervention ( 0.92 + /- 0.10 kg ) than in the control ( 0.62 + /- 0.11 kg ) group . The increase in height was also greater ( P = 0.01 ) in the intervention group ( 2.50 + /- 0.21 cm ) than in the control group ( 1.77 + /- 0.20 cm ) for boys but not for girls . CONCLUSION Replacing habitual consumption of SSBs with milk may have beneficial effects on lean body mass and growth in children , despite no changes in percentage body fat . This trial was registered at clinical trials.gov as NCT00149695",
"BACKGROUND Inflammation is considered a key mechanism leading to type 2 diabetes , but dietary exposures that lead to inflammation and diabetes are largely unknown . OBJECTIVE Our objective was to investigate the relation between a dietary pattern associated with biomarkers of inflammation and the incidence of type 2 diabetes . DESIGN We conducted a nested case-control study of 656 cases of type 2 diabetes and 694 controls among women in the Nurses ' Health Study and 2 prospect i ve cohort studies of 35,340 women in the Nurses ' Health Study and 89,311 women in the Nurses ' Health Study II who were followed for incident diabetes . RESULTS Through the use of reduced rank regression , we identified a dietary pattern that was strongly related to inflammatory markers in the nested case-control study . This pattern , which was high in sugar-sweetened soft drinks , refined grains , diet soft drinks , and processed meat but low in wine , coffee , cruciferous vegetables , and yellow vegetables , was associated with an increased risk of diabetes ( multivariate-adjusted odds ratio comparing extreme quintiles : 3.09 ; 95 % CI : 1.99 , 4.79 ) . We identified 1517 incident cases of confirmed type 2 diabetes in the Nurses ' Health Study ( 458,991 person-years ) and 724 incident cases in the Nurses ' Health Study II ( 701,155 person-years ) . After adjustment for body mass index and other potential lifestyle confounders , the relative risks comparing extreme quintiles of the pattern were 2.56 ( 95 % CI : 2.10 , 3.12 ; P for trend dietary pattern identified may increase chronic inflammation and raise the risk of developing type 2 diabetes",
"BACKGROUND Potatoes , a high glycemic form of carbohydrate , are hypothesized to increase insulin resistance and risk of type 2 diabetes . OBJECTIVE The objective was to examine prospect ively the relation between potato consumption and the risk of type 2 diabetes . DESIGN We conducted a prospect i ve study of 84,555 women in the Nurses ' Health Study . At baseline , the women were aged 34 - 59 y , had no history of chronic disease , and completed a vali date d food-frequency question naire . The participants were followed for 20 y with repeated assessment of diet . RESULTS We documented 4496 new cases of type 2 diabetes . Potato and french fry consumption were both positively associated with risk of type 2 diabetes after adjustment for age and dietary and nondietary factors . The multivariate relative risk ( RR ) in a comparison between the highest and the lowest quintile of potato intake was 1.14 ( 95 % CI : 1.02 , 1.26 ; P for trend = 0.009 ) . The multivariate RR in a comparison between the highest and the lowest quintile of french fry intake was 1.21 ( 95 % CI : 1.09 , 1.33 ; P for trend RR of type 2 diabetes was 1.18 ( 95 % CI : 1.03 , 1.35 ) for 1 daily serving of potatoes and 1.16 ( 95 % CI : 1.05 , 1.29 ) for 2 weekly servings of french fries . The RR of type 2 diabetes for substituting 1 serving potatoes/d for 1 serving whole grains/d was 1.30 ( 95 % CI : 1.08 , 1.57 ) . The association between potato consumption and risk of type 2 diabetes was more pronounced in obese women . CONCLUSIONS Our findings suggest a modest positive association between the consumption of potatoes and the risk of type 2 diabetes in women . This association was more pronounced when potatoes were substituted for whole grains",
"The study objective was to determine whether a small dose of fructose administered before or simultaneously with a high glycemic index , starchy food decreases postpr and ial glycemic response . Nondiabetic healthy adults ( n = 31 ; mean + /- SEM : age , 26 + /- 1 y ; weight , 66.1 + /- 2.6 kg ; body mass index , 23.3 + /- 0.6 kg/m(2 ) ) were studied in a r and omized crossover design . Treatments consisted of 50 g available carbohydrate from instant mashed potatoes fed alone ( control ) or with 10 g fructose fed 60 , 30 or 0 min before the potato meal . Capillary finger-stick blood sample s were analyzed for glucose concentration at -60 , -30 , 0 , 15 , 30 , 45 , 60 , 90 and 120 min relative to the ingestion of the potato meal . Compared with the control , the positive incremental area under the glucose curve was reduced 25 and 27 % ( P fructose lowers the glycemic response to a glucose solution , we found that fructose must be consumed before a starchy food to reduce postpr and ial glycemia",
"Background / Objectives : Diets high in saturated and trans fat and low in unsaturated fat may increase type 2 diabetes ( T2D ) risk , but studies on foods high in fat per unit weight are sparse . We assessed whether the intake of vegetable oil , butter , margarine , nuts and seeds and cakes and cookies is related to incident T2D.Subjects/ Methods : A case-cohort study was conducted , nested within eight countries of the European Prospect i ve Investigation into Cancer ( EPIC ) , with 12 403 incident T2D cases and a subcohort of 16 835 people , identified from a cohort of 340 234 people . Diet was assessed at baseline ( 1991–1999 ) by country-specific question naires . Country-specific hazard ratios ( HRs ) across four categories of fatty foods ( nonconsumers and tertiles among consumers ) were combined with r and om-effects meta- analysis . Results : After adjustment not including body mass index ( BMI ) , nonconsumers of butter , nuts and seeds and cakes and cookies were at higher T2D risk compared with the middle tertile of consumption . Among consumers , cakes and cookies were inversely related to T2D ( HRs across increasing tertiles 1.14 , 1.00 and 0.92 , respectively ; P-trend consumption of margarine became positively associated after BMI adjustment ( HRs across increasing consumption tertiles : 0.93 , 1.00 and 1.12 ; P-trend 0.03 ) . Within consumers , vegetable oil , butter and nuts and seeds were unrelated to T2D . Conclusions : Fatty foods were generally not associated with T2D , apart from weak positive association for margarine . The higher risk among nonconsumers of cakes and cookies needs further explanation",
"BACKGROUND The consumption of sucrose-sweetened soft drinks ( SSSDs ) has been associated with obesity , the metabolic syndrome , and cardiovascular disorders in observational and short-term intervention studies . Too few long-term intervention studies in humans have examined the effects of soft drinks . OBJECTIVE We compared the effects of SSSDs with those of isocaloric milk and a noncaloric soft drink on changes in total fat mass and ectopic fat deposition ( in liver and muscle tissue ) . DESIGN Overweight subjects ( n = 47 ) were r and omly assigned to 4 different test drinks ( 1 L/d for 6 mo ) : SSSD ( regular cola ) , isocaloric semiskim milk , aspartame-sweetened diet cola , and water . The amount of intrahepatic fat and intramyocellular fat was measured with (1)H-magnetic resonance spectroscopy . Other endpoints were fat mass , fat distribution ( dual-energy X-ray absorptiometry and magnetic resonance imaging ) , and metabolic risk factors . RESULTS The relative changes between baseline and the end of 6-mo intervention were significantly higher in the regular cola group than in the 3 other groups for liver fat ( 132 - 143 % , sex-adjusted mean ; P skeletal muscle fat ( 117 - 221 % ; P visceral fat ( 24 - 31 % ; P blood triglycerides ( 32 % ; P total cholesterol ( 11 % ; P Total fat mass was not significantly different between the 4 beverage groups . Milk and diet cola reduced systolic blood pressure by 10 - 15 % compared with regular cola ( P diet cola had effects similar to those of water . CONCLUSION Daily intake of SSSDs for 6 mo increases ectopic fat accumulation and lipids compared with milk , diet cola , and water . Thus , daily intake of SSSDs is likely to enhance the risk of cardiovascular and metabolic diseases . This trial is registered at clinical trials.gov as NCT00777647",
"IMPORTANCE Increases in fructose consumption have paralleled the increasing prevalence of obesity , and high-fructose diets are thought to promote weight gain and insulin resistance . Fructose ingestion produces smaller increases in circulating satiety hormones compared with glucose ingestion , and central administration of fructose provokes feeding in rodents , whereas central ly administered glucose promotes satiety . OBJECTIVE To study neurophysiological factors that might underlie associations between fructose consumption and weight gain . DESIGN , SETTING , AND PARTICIPANTS Twenty healthy adult volunteers underwent 2 magnetic resonance imaging sessions at Yale University in conjunction with fructose or glucose drink ingestion in a blinded , r and om-order , crossover design . MAIN OUTCOME MEASURES Relative changes in hypothalamic regional cerebral blood flow ( CBF ) after glucose or fructose ingestion . Secondary outcomes included whole-brain analyses to explore regional CBF changes , functional connectivity analysis to investigate correlations between the hypothalamus and other brain region responses , and hormone responses to fructose and glucose ingestion . RESULTS There was a significantly greater reduction in hypothalamic CBF after glucose vs fructose ingestion ( -5.45 vs 2.84 mL/g per minute , respectively ; mean difference , 8.3 mL/g per minute [ 95 % CI of mean difference , 1.87 - 14.70 ] ; P = .01 ) . Glucose ingestion ( compared with baseline ) increased functional connectivity between the hypothalamus and the thalamus and striatum . Fructose increased connectivity between the hypothalamus and thalamus but not the striatum . Regional CBF within the hypothalamus , thalamus , insula , anterior cingulate , and striatum ( appetite and reward regions ) was reduced after glucose ingestion compared with baseline ( P contrast , fructose reduced regional CBF in the thalamus , hippocampus , posterior cingulate cortex , fusiform , and visual cortex ( P of fructose vs glucose sessions following correction for multiple comparisons . Fructose vs glucose ingestion result ed in lower peak levels of serum glucose ( mean difference , 41.0 mg/dL [ 95 % CI , 27.7 - 54.5 ] ; P .001 ) , insulin ( mean difference , 49.6 μU/mL [ 95 % CI , 38.2 - 61.1 ] ; P and glucagon-like polypeptide 1 ( mean difference , 2.1 pmol/L [ 95 % CI , 0.9 - 3.2 ] ; P = .01 ) . CONCLUSION AND RELEVANCE In a series of exploratory analyses , consumption of fructose compared with glucose result ed in a distinct pattern of regional CBF and a smaller increase in systemic glucose , insulin , and glucagon-like polypeptide 1 levels",
"When the first edition of A Dictionary of Epidemiology was launched in 1983 , its principal aim was to facilitate communication among health professionals . The field was relatively young and comprised complex interdisciplinary relations ranging from the biomedical sciences to statistics and the social sciences . The International Epidemiological Association ( IEA ) co-sponsored the project with the aim of developing certain st and ards for teaching , research reports and communication of epidemiological findings to the public . This is a well-known history : John M Last , the emeritus professor of epidemiology and community medicine from the University of Ottawa , Canada , was appointed as the editor of A Dictionary ... , and kept ahead of the task during the subsequent decades . The original slim pocket book grew substantially with each re-edit , keeping pace with the remarkable developments in the discipline . When the fourth edition was launched in 2001 , John Last told me with a smile that he would die soon , supposedly to increase the value of the signature he had just h and written in my book . Fortunately , he did not , and his love for dictionary-making allowed him to produce his A Dictionary of Public Health , and to collaborate in the recently launched fifth edition of A Dictionary ... , now edited by Miquel Porta , professor of preventive medicine and public health from the Universitat Autònoma de Barcelona , senior scientist of the Institut Municipal d’Investigació Mèdica in Barcelona , Spain , and collaborator in the previous editions . If he had to limit his professional bookcase to a single volume , Professor Charles du V Florey , the former president of the IEA , would choose to keep A Dictionary .... I argue that anybody among us — epidemiologists and would-be epidemiologists ( hopefully with a larger shelf)—should also have a copy of this book at h and for frequent consultation . The collective effort gathered in its making is impressive . Miquel Porta has built over the previously crafted editions , and has relied on the support of a wide network of professionals to up date each entry and to exp and the selection of subjects . The Journal of Epidemiology and Community Health joined the initiative by publishing a call for su bmi ssions . Items already selected from the previous edition have been revised and up date d ; several new items have been added . As a result , the fifth edition of A Dictionary ... performs normative and informative functions : you will be informed on important matters and instructed on how to proceed in the epidemiological field . Readers with different needs and anxieties with knowledge will find straightforward writing , authoritative definitions and pertinent bibliographical references . How to differentiate a rate from a ratio , incidence from prevalence , confounding from intervening variables , type I from type II error ? How to appraise emerging themes in the epidemiological literature such as genetic polymorphisms and Bayesian statistics ? Key method ological issues such as meta- analysis , multilevel analysis and regression models : the list solely enrols a small sample of possible search es . The selection of issues was broad in scope ; intelligent and synthetic writing contemplated from the easier to the more intricate subjects . You may want to up date conceptual and method ological issues relevant to your teaching and research activities , to resolve doubts or to confirm an impression . You may want to check on terminology , fulfil curiosities or learn about topics unrelated to your preferential themes . You may be a professional applied to other health specialities , an undergraduate or a high school student . Several users will meet their needs by consulting A Dictionary ... ; even those who aim lessly scan the text may find some valuable insight . While it will not resolve all your needs in the epidemiological field , it surely provides enough substance to build on — a very good start or ammunition for more comprehensive search es . Miquel Porta dealt with the challenge of preparing reader-friendly texts on a wide range of subjects , which will satisfy both a beginner and an experienced epidemiologist . He seems to have transposed Occam ’s razor ( see the correspondent entry : ‘ ‘ the philosophical principle of parsimony ... assumptions to explain a phenomenon must not be multiplied beyond necessity ... ’ ’ ) to the writing of the book . If I may indulge in selftestimony , I found my teenage daughter consulting the book and it motivated a conversation on subjects so dear to me .... Arousing the interest of the young for a speciality admittedly perceived as difficult by adolescents ; as goes the popular saying , this is priceless ! ‘ ‘ Epidemiology is the study of the occurrence and distribution of healthrelated states or events in specified population s , including the study of the determinants influencing such states , and the application of this knowledge to control the health problems ’ ’ . The definition has matured over the years and presents slight modifications from its previous formulation in the fourth edition . The entry for ‘ ‘ Epidemiology ’ ’ exp and s the conceptualisation of terms comprised in the definition and includes historical aspects . In subsequent years , this definition will be the benchmark of the discipline , until Miquel Porta and his collaborators eventually prepare a further edition to meet the new needs that the future may bring forth . I dare to guess that the prospect i ve sixth edition of A Dictionary ... will have an online dynamic interface interacting with the hard copy . I also dare to guess that it will include a new entry for A Dictionary of Epidemiology , whose importance to the professional field will surely have earned it",
"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",
"Previous studies indicate that leptin secretion is regulated by insulin-mediated glucose metabolism . Because fructose , unlike glucose , does not stimulate insulin secretion , we hypothesized that meals high in fructose would result in lower leptin concentrations than meals containing the same amount of glucose . Blood sample s were collected every 30 - 60 min for 24 h from 12 normal-weight women on 2 r and omized days during which the subjects consumed three meals containing 55 , 30 , and 15 % of total kilocalories as carbohydrate , fat , and protein , respectively , with 30 % of kilocalories as either a fructose-sweetened [ high fructose ( HFr ) ] or glucose-sweetened [ high glucose ( HGl ) ] beverage . Meals were isocaloric in the two treatments . Postpr and ial glycemic excursions were reduced by 66 + /- 12 % , and insulin responses were 65 + /- 5 % lower ( both P area under the curve for leptin during the first 12 h ( -33 + /- 7 % ; P diurnal amplitude ( peak - nadir ) ( 24 + /- 6 % ; P levels of the orexigenic gastroenteric hormone , ghrelin , were suppressed by approximately 30 % 1 - 2 h after ingestion of each HGl meal ( P suppression of ghrelin was significantly less pronounced after HFr meals ( P elevation of plasma triglycerides compared with the HGl day ( P circulating insulin and leptin and increased ghrelin concentrations , as demonstrated in this study , could lead to increased caloric intake and ultimately contribute to weight gain and obesity during chronic consumption of diets high in fructose",
"Background Current dietary guidelines recommend eating a variety of fruits and vegetables . However , based on nutrient composition , some particular fruits and vegetables may be more or less beneficial for maintaining or achieving a healthy weight . We hypothesized that greater consumption of fruits and vegetables with a higher fiber content or lower glycemic load would be more strongly associated with a healthy weight . Methods and Findings We examined the association between change in intake of specific fruits and vegetables and change in weight in three large , prospect i ve cohorts of 133,468 United States men and women . From 1986 to 2010 , these associations were examined within multiple 4-y time intervals , adjusting for simultaneous changes in other lifestyle factors , including other aspects of diet , smoking status , and physical activity . Results were combined using a r and om effects meta- analysis . Increased intake of fruits was inversely associated with 4-y weight change : total fruits -0.53 lb per daily serving ( 95 % CI -0.61 , -0.44 ) , berries -1.11 lb ( 95 % CI -1.45 , -0.78 ) , and apples/pears -1.24 lb ( 95 % CI -1.62 , -0.86 ) . Increased intake of several vegetables was also inversely associated with weight change : total vegetables -0.25 lb per daily serving ( 95 % CI -0.35 , -0.14 ) , tofu/soy -2.47 lb ( 95 % CI , -3.09 to -1.85 lb ) and cauliflower -1.37 lb ( 95 % CI -2.27 , -0.47 ) . On the other h and , increased intake of starchy vegetables , including corn , peas , and potatoes , was associated with weight gain . Vegetables having both higher fiber and lower glycemic load were more strongly inversely associated with weight change compared with lower-fiber , higher-glycemic-load vegetables ( p fruits and non-starchy vegetables is inversely associated with weight change , with important differences by type suggesting that other characteristics of these foods influence the magnitude of their association with weight change",
"OBJECTIVE To investigate prospect ively whether intake of total or type of sugar is associated with the risk of developing type 2 diabetes . The contribution of sugar intake to the pathogenesis of type 2 diabetes has not been settled in the context of primary prevention because of limited prospect i ve data . RESEARCH DESIGN AND METHODS The Women 's Health Study is a r and omized controlled trial of aspirin and vitamin E in the prevention of cardiovascular disease and cancer . A vali date d semiquantitative food frequency question naire was completed by 39,345 women aged 45 years and older . The main outcome was the incidence of type 2 diabetes . The predictor was sugar intake , including sucrose , glucose , fructose , and lactose . Using Cox proportional hazard models , multivariate RRs of type 2 diabetes for increasing quintiles of sugar intake compared with the lowest quintile were estimated . RESULTS Compared with the lowest quintile of sugar intake , the RRs and 95 % CIs for the highest quintiles were 0.84 ( 0.67 - 1.04 ) for sucrose , 0.96 ( 0.78 - 1.19 ) for fructose , 1.04 ( 0.85 - 1.28 ) for glucose , and 0.99 ( 0.80 - 1.22 ) for lactose , after adjustment for known risk factors for type 2 diabetes . Similar findings of no association were obtained in subgroup analyses stratified by BMI . CONCLUSIONS Intake of sugars does not appear to play a deleterious role in primary prevention of type 2 diabetes . These prospect i ve data support the recent American Diabetes Association 's guideline that a moderate amount of sugar can be incorporated in a healthy diet",
"BACKGROUND Consumption of sugar-sweetened beverages ( SSBs ) is associated with an increased risk of hypertension in cross-sectional studies . However , prospect i ve data are limited . OBJECTIVE To examine the associations between SSBs and artificially sweetened beverages ( ASBs ) with incident hypertension . DESIGN AND SETTING Prospect i ve analysis using Cox proportional hazards regression to examine the association between SSBs and ASBs with incident hypertension in three large , prospect i ve cohorts , the Nurses ' Health Studies I ( n = 88,540 women ) and II ( n = 97,991 women ) and the Health Professionals ' Follow-Up Study ( n = 37,360 men ) . MEASUREMENTS Adjusted hazard ratios for incident clinical ly diagnosed hypertension . RESULTS Higher SSB and ASB intake was associated with an increased risk of developing hypertension in all three cohorts . In a pooled analysis , participants who consumed at least one SSB daily had an adjusted HR for incident hypertension of 1.13 ( 95 % CI , 1.09–1.17 ) compared with those who did not consume SSBs ; for persons who drank at least one ASB daily , the adjusted HR was 1.14 ( 95 % CI , 1.09–1.18 ) . The association between sweetened beverage intake and hypertension was stronger for carbonated beverages versus non-carbonated beverages , and for cola-containing versus non-cola beverages in the NHS I and NHS II cohorts only . Higher fructose intake from SSBs as a percentage of daily calories was associated with increased hypertension risk in NHS I and NHS II ( p-trend = 0.001 in both groups ) , while higher fructose intake from sources other than SSBs was associated with a decrease in hypertension risk in NHS II participants ( p-trend = 0.006 ) . LIMITATIONS Residual confounding factors may interfere with the interpretation of results . CONCLUSIONS SSBs and ASBs are independently associated with an increased risk of incident hypertension after controlling for multiple potential confounders . These associations may be mediated by factors common to both SSBs and ASBs ( e.g. , carbonation or cola ) , but are unlikely to be due to fructose",
"Beverage consumption has been implicated in weight gain , but questions remain about the veracity of the association , whether the relationship is causal and what property of beverages is responsible . It was hypothesized that food form is the most salient attribute . Thus , a r and omized controlled trial of food form was conducted . Energy-matched beverage or solid forms of fruits and vegetables were provided to 34 , lean or overweight/obese adults for two 8-week periods with a 3-week washout interspersed . Dietary compensation was incomplete ( beverage 53 % ; solid 78 % ) and body weight increased after the beverage ( 1.95 ± 0.33 kg ) ( 77 % fat mass ) and solid ( 1.36 ± 0.30 kg ) ( 85 % fat mass ) treatments ( both P highest dietary compensation ( 119 % ) and no significant weight change ( 0.84 ± 0.53 kg ) after consuming the solid fruits and vegetables whereas the overweight/obese group had lower compensation and significant weight gain during the solid arm ( 46 % , 1.77 ± 0.32 kg , P , incomplete dietary compensation and weight gain occurred in both the lean ( 43 % , 1.61 ± 0.44 kg , P = 0.003 ) and overweight/obese ( 61 % , 2.22 ± 0.47 kg , P the obese group gained more weight than the lean and overweight groups during the beverage intervention ( P = 0.024 ) . These data demonstrate energy consumed as beverages may be especially problematic for weight gain . They also indicate that advice to increase fruit and vegetable consumption should emphasize total energy intake because the additional energy contributed may promote weight gain , especially among overweight and obese individuals",
"OBJECTIVE To examine the effect on plasma triglycerides of removing most of the extrinsic sugar from the diet of free living hypertriglyceridaemic individuals while controlling weight loss . DESIGN Free living subjects were r and omly assigned to intervention and control groups . The intervention group undertook to consume a \" sugar free ' diet for six months after a three month baseline period . The control group maintained their usual diets for the nine month period . The results from the two groups were compared using repeated measures ANOVA . SUBJECTS Thirty two hypertriglyceridaemic individuals , selected from members of the public in Dunedin , New Zeal and . RESULTS Subjects in the intervention group were able to achieve a mean reduction in sucrose intake of > 70 % , largely extrinsic sucrose , result ing in a group mean reduction in plasma triglyceride levels of > 20 % and a mean weight loss over the six month period of about 2 % . Repeated measures ANOVA on the mean triglyceride figures after the individual figures had been adjusted for this small weight loss , showed that there was a significant fall in triglyceride levels over the study period compared with the baseline . CONCLUSIONS Hypertriglyceridaemia can be reduced in some individuals by the reduction of extrinsic sucrose in the diet . When allowance is made for weight loss the reduction is still significant",
"BACKGROUND Exercise prevents the adverse effects of a high-fructose diet through mechanisms that remain unknown . OBJECTIVE We assessed the hypothesis that exercise prevents fructose-induced increases in very-low-density lipoprotein ( VLDL ) triglycerides by decreasing the fructose conversion into glucose and VLDL-triglyceride and fructose carbon storage into hepatic glycogen and lipids . DESIGN Eight healthy men were studied on 3 occasions after 4 d consuming a weight-maintenance , high-fructose diet . On the fifth day , the men ingested an oral (13)C-labeled fructose load ( 0.75 g/kg ) , and their total fructose oxidation ( (13)CO2 production ) , fructose storage ( fructose ingestion minus (13)C-fructose oxidation ) , fructose conversion into blood (13)C glucose ( gluconeogenesis from fructose ) , blood VLDL-(13)C palmitate ( a marker of hepatic de novo lipogenesis ) , and lactate concentrations were monitored over 7 postpr and ial h. On one occasion , participants remained lying down throughout the experiment [ fructose treatment alone with no exercise condition ( NoEx ) ] , and on the other 2 occasions , they performed a 60-min exercise either 75 min before fructose ingestion [ exercise , then fructose condition ( ExFru ) ] or 90 min after fructose ingestion [ fructose , then exercise condition ( FruEx ) ] . RESULTS Fructose oxidation was significantly ( P Consequently , fructose storage was lower in the FruEx than in the other 2 conditions ( P 0.001 ) . Fructose conversion into blood (13)C glucose , VLDL-(13)C palmitate , and postpr and ial plasma lactate concentrations was not significantly different between conditions . CONCLUSIONS Compared with sedentary conditions , exercise performed immediately after fructose ingestion increases fructose oxidation and decreases fructose storage . In contrast , exercise performed before fructose ingestion does not significantly alter fructose oxidation and storage . In both conditions , exercise did not abolish fructose conversion into glucose or its incorporation into VLDL triglycerides . This trial was registered at clinical trials.gov as NCT01866215",
"BACKGROUND : Beverages are contributing an increased proportion of energy to the diet . Because they elicit a weak compensatory dietary response , they may increase risk of positive energy balance . OBJECTIVES : This study aim ed to document the differential effects of matched liquid and solid carbohydrate loads on diet and body weight . DESIGN : In a cross-over design , seven males and eight females consumed dietary carbohydrate loads of 1880 kJ/day as a liquid ( soda ) or solid ( jelly beans ) during two 4 week periods separated by a 4 week washout . Subjects were permitted to consume the loads however they chose . In addition to baseline measurements , diet records were obtained on r and om days throughout the study , body composition was measured weekly , physical activity was assessed before and after treatments and hunger was assessed during washout and midway through each treatment . RESULTS : Free-feeding energy intake during the solid period was significantly lower than intake prior to this period . Dietary energy compensation was precise ( 118 % ) . No decrease in free-feeding energy intake occurred during the liquid period . Total daily energy intake increased by an amount equal to the load result ing in dietary compensation of −17 % . Consequently , body weight and BMI increased significantly only during the liquid period . Physical activity and hunger were unchanged . CONCLUSIONS : This study indicates that liquid carbohydrate promotes positive energy balance , whereas a comparable solid carbohydrate elicits precise dietary compensation . Increased consumption of energy-yielding fluids may promote positive energy balance",
"People are advised to reduce their intake of saturated fat and replace it by carbohydrate to avoid coronary heart disease . It is unknown whether sucrose and starchy foods , two major sources of carbohydrates , have similar effects on cardiovascular risk markers if incorporated as a replacement for saturated fat into diets eaten ad libitum . We served 20 healthy , normal-weight women aged 21 to 52 years three strictly controlled diets ad libitum : FAT , high in total fat ( 46 % of total energy [ E% ] ) and saturated fat ( 21 E% ) ; STARCH , high in total carbohydrates ( 59 E% ) and low in sucrose ( 2.5 E% ) ; and SUCROSE , high in total carbohydrates ( 59 E% ) and sucrose ( 23.2 E% ) . The diets were eaten in r and omized order for a period of 2 weeks . Blood lipids , factor VII coagulant activity ( FVIIc ) , and fibrinogen concentrations were measured with subjects in the fasted state ( 9:45 AM ) and the postabsorptive state ( 6:00 PM ) . STARCH was associated with lower total cholesterol ( mean difference , 0.34 mmol/L ; 95 % confidence interval [ CI ] , 0.18 to 0.50 ) , low-density lipoprotein ( LDL ) cholesterol ( 0.25 mmol/L ; 95 % CI , 0.13 to 0.37 ) , fasting triglycerides ( 0.15 mmol/L ; 95 % CI , 0.07 to 0.23 ) , nonfasting triglycerides ( 0.44 mmol/L ; 95 % CI , 0.30 to 0.58 ) , and nonfasting FVIIc ( 9.8 % ; 95 % CI , 3.8 to 15.8 ) than SUCROSE . Compared with FAT , STARCH result ed in a desirable decrease of LDL cholesterol and nonfasting FVIIc . STARCH was also associated with a minor weight loss ( 0.7 kg ) that was not found on the other 2 diets . We conclude that starchy foods with a natural content of dietary fiber can be recommended as substitutes for saturated fat in the dietary prevention of coronary heart disease . According to the present short-term findings in healthy females , substitution with sucrose is not advisable",
"BACKGROUND Consumption of sugar-sweetened soda has been associated with an increased risk of cardiometabolic disease . The relation with cerebrovascular disease has not yet been closely examined . OBJECTIVE Our objective was to examine patterns of soda consumption and substitution of alternative beverages for soda in relation to stroke risk . DESIGN The Nurses ' Health Study , a prospect i ve cohort study of 84,085 women followed for 28 y ( 1980 - 2008 ) , and the Health Professionals Follow-Up Study , a prospect i ve cohort study of 43,371 men followed for 22 y ( 1986 - 2008 ) , provided data on soda consumption and incident stroke . RESULTS We documented 1416 strokes in men during 841,770 person-years of follow-up and 2938 strokes in women during 2,188,230 person-years of follow-up . The pooled RR of total stroke for ≥ 1 serving of sugar-sweetened soda/d , compared with none , was 1.16 ( 95 % CI : 1.00 , 1.34 ) . The pooled RR of total stroke for ≥ 1 serving of low-calorie soda/d , compared with none , was 1.16 ( 95 % CI : 1.05 , 1.28 ) . Compared with 1 serving of sugar-sweetened soda/d , 1 serving of decaffeinated coffee/d was associated with a 10 % ( 95 % CI : 1 % , 19 % ) lower risk of stroke and 1 serving of caffeinated coffee/d with a 9 % ( 95 % CI : 0 % , 17 % ) lower risk . Similar estimated reductions in risk were seen for substitution of caffeinated or decaffeinated coffee for low-calorie soda . CONCLUSIONS Greater consumption of sugar-sweetened and low-calorie sodas was associated with a significantly higher risk of stroke . This risk may be reduced by substituting alternative beverages for soda",
"BACKGROUND Although obesity is the most important risk factor for type 2 diabetes , evidence is emerging that certain foods and dietary factors may be associated with diabetes . To examine the association between major dietary patterns and risk of type 2 diabetes mellitus in a cohort of women . METHODS We prospect ively assessed the associations between major dietary patterns and risk of type 2 diabetes in women . Dietary information was collected in 1984 , 1986 , 1990 , and 1994 from 69,554 women aged 38 to 63 years without a history of diabetes , cardiovascular disease , or cancer in 1984 . We conducted factor analysis and identified 2 major dietary patterns : \" prudent \" and \" Western . \" We then calculated pattern scores for each participant and examined prospect ively the associations between dietary pattern scores and type 2 diabetes risks . RESULTS The prudent pattern was characterized by higher intakes of fruits , vegetables , legumes , fish , poultry , and whole grains , while the Western pattern included higher intakes of red and processed meats , sweets and desserts , french fries , and refined grains . During 14 years of follow-up , we identified 2699 incident cases of type 2 diabetes . After adjusting for potential confounders , we observed a relative risk for diabetes of 1.49 ( 95 % confidence interval [ CI ] , 1.26 - 1.76 , P for trend , type 2 diabetes and red meat and other processed meats . The relative risk for diabetes for every 1-serving increase in intake is 1.26 ( 95 % CI , 1.21 - 1.42 ) for red meat , 1.38 ( 95 % CI , 1.23 - 1.56 ) for total processed meats , 1.73 ( 95 % CI , 1.39 - 2.16 ) for bacon , 1.49 ( 95 % CI , 1.04 - 2.11 ) for hot dogs , and 1.43 ( 95 % CI , 1.22 - 1.69 ) for processed meats . CONCLUSION The Western pattern , especially a diet higher in processed meats , may increase the risk of type 2 diabetes in women",
"BACKGROUND Although substantial information on individual nutrients or foods and risk of coronary heart disease ( CHD ) is available , little is known about the role of overall eating pattern . METHODS Using dietary information from a food frequency question naire in 1984 from the Nurses ' Health Study , we conducted factor analysis and identified 2 major dietary patterns-\"prudent \" and \" Western\"- and calculated factor scores of each pattern for individuals in the cohort . We used logistic regression to examine prospect ively the associations between dietary patterns and CHD risk among 69 017 women aged 38 to 63 years in 1984 without history of major chronic diseases . RESULTS The prudent pattern was characterized by higher intakes of fruits , vegetables , legumes , fish , poultry , and whole grains , while the Western pattern was characterized by higher intakes of red and processed meats , sweets and desserts , french fries , and refined grains . Between 1984 and 1996 , we documented 821 CHD cases . After adjusting for coronary risk factors , the prudent diet score was associated with a relative risk ( RR ) of 0.76 ( 95 % confidence interval ( CI ) , 0.60 - 0.98 ; P for trend test,.03 ) comparing the highest with lowest quintile . Extreme quintile comparison yielded an RR of 1.46 ( 95 % CI , 1.07 - 1.99 ; P for trend test,.02 ) for the Western pattern . Those who were jointly in the highest prudent diet quintile and lowest Western diet quintile had an RR of 0.64 ( 95 % CI , 0.44 - 0.92 ) compared with those with the opposite pattern profile . CONCLUSION A diet high in fruits , vegetables , whole grains , legumes , poultry , and fish and low in refined grains , potatoes , and red and processed meats may lower risk of CHD",
"The prevalence of type 2 diabetes mellitus is rapidly increasing in the United States ( 1 , 2 ) and worldwide ( 3 ) . Ecologic studies ( 4 ) , migration studies ( 4 , 5 ) , and analyses of secular trends ( 4 , 6 ) suggest that adoption of a western diet may be associated with increased incidence of type 2 diabetes . However , these studies could not separate the effects of diet from those of other risk factors , such as obesity and physical activity . Studies of the relation between diet and incidence of type 2 diabetes on an individual level have predominantly focused on intake of macronutrients and fiber ( 7 ) . However , these dietary factors alone probably explain only part of the effect of diet on glucose metabolism . Other nutrients , additives , contaminants , and unknown compounds and the physical properties of foods and interactions between nutrients ( for example , with respect to bioavailability ) may play a role in the deterioration of glucose metabolism . Hence , the examination of effects of food consumption may be an important complementary approach . Recently , the analysis of patterns of food consumption by using factor analysis has emerged as a useful tool for elucidating relationships between diet and health ( 8 - 11 ) . The overall dietary pattern may affect health more than individual foods and nutrients do . Furthermore , dietary patterns reflect the way foods are consumed in reality , which may provide insight into possibilities for dietary changes and may facilitate the translation of findings to public health recommendations . Recent dietary intervention studies have indicated that interventions focused on dietary patterns can decrease blood pressure ( 12 ) and reduce cardiovascular complications ( 13 ) . Data on dietary patterns and risk for type 2 diabetes are sparse . Although two cross-sectional studies of dietary patterns and diabetes have been conducted ( 11 , 14 ) , these studies incompletely controlled for confounding by other lifestyle factors . Therefore , we prospect ively examined the association between major dietary patterns and risk for type 2 diabetes in a large prospect i ve study of U.S. professional men with extensive , repeatedly obtained information on diet and other lifestyle factors . Methods Participants The Health Professionals Follow-up Study started in 1986 , when 51 529 male health professionals ( dentists , veterinarians , pharmacists , optometrists , osteopathic physicians , and podiatrists ) completed a detailed mailed question naire on medical history , diet , and other potential risk factors for major diseases . The participants lived in all 50 U.S. states , were predominantly white , and were 40 to 75 years of age in 1986 . We excluded from the current analysis 1595 men who did not satisfy the a priori criteria of reporting daily energy intake of 3.3 to 17.6 MJ ( 800 to 4200 kcal/24 h ) and leaving fewer than 70 responses blank of the 131 food items on the diet question naire ( 11 blanks ) . We also excluded men who reported having diabetes , cardiovascular disease ( myocardial infa rct ion , angina pectoris , coronary artery surgery , or stroke ) , or cancer ( except nonmelanoma skin cancer ) at baseline because having these diagnoses may affect diet or reporting of diet . After exclusions , the study sample comprised 42 504 men , who were followed for incidence of type 2 diabetes and other diseases for 12 years ( 1986 to 1998 ) . Every 2 years , the participants received question naires by mail that asked for up date d information on exposures and newly diagnosed diseases . The follow-up rate for potential person-years was about 97 % for nonfatal events . We identified deaths by reports from family members , coworkers , or postal authorities or through systematic search es of the National Death Index . Assessment of Dietary Patterns To assess dietary intake , we used a 131-item semiquantitative food-frequency question naire in 1986 , 1990 , and 1994 . The question naire specified for each food a commonly used unit or portion size , and the participants were asked to indicate how often , on average , they had consumed a given amount of the specified food during the past year . Each such item provided nine possible responses , ranging from never or less than once a month to 6 or more times per day . To reduce within-respondent variation and to best represent long-term dietary habits , we averaged the dietary intakes from all available dietary question naires up to the start of each follow-up interval ( the average of the 1986 and 1990 dietary intakes was related to incidence of type 2 diabetes between 1990 and 1994 ) ( 15 ) . To identify dietary patterns , we applied factor analysis to data from the food-frequency question naire . First , we grouped the food items on the question naire into 37 predefined food groups . We combined food items that were similar in nutrient profile and culinary use ( for example , spinach , iceberg or head lettuce , and romaine or leaf lettuce were combined into green leafy vegetables ) . We classified a food item individually if its composition differed substantially from that of other foods ( for example , eggs or pizza ) or if we suspected that it represents a particular dietary habit ( for example , wine or French fries ) . Second , we applied the principal components program for factor analysis of SAS software ( 16 ) with varimax rotation to the 37 food groups . Factor analysis aggregates correlated variables . The obtained factors are linear combinations of the included variables , explaining as much of the variation in the original variables as possible . Our analysis retained two factors based on the eigenvalue of the factors , the Scree test , and the interpretability of the derived factors , and we labeled these diets as the prudent pattern and the western pattern ( 9 ) . Third , for each participant , we calculated a prudent pattern score and a western pattern score by summing the st and ardized intake of foods , weighted by the factor loadings of the foods ( 17 ) . We used these scores to rank participants according to the degree to which they conformed to each dietary pattern . We divided dietary pattern scores into quintiles ; thus , on this basis of his scores , each participant was grouped in a prudent-pattern quintile and a western-pattern quintile . To test the validity and reproducibility of the assessment of the dietary pattern scores by the food-frequency question naire , we examined a subgroup of 127 participants ( 9 ) . The Pearson correlation coefficient ( corrected for week-to-week variation in the diet records ) for a comparison between the responses to the food-frequency question naire and the diet records was 0.52 for the prudent dietary pattern and 0.74 for the western dietary pattern . Assessment of Nondietary Exposures The 1986 question naire and each biennial follow-up question naire assessed weight , smoking status , and physical activity . Participants provided information on age , diagnosis of hypertension and hypercholesterolemia , and height in 1986 and on family history of diabetes in 1987 . The criterion for family history of type 2 diabetes was having at least one first-degree relative with a diagnosis of diabetes after 30 years of age . For each participant , we determined a physical activity level , measured in weekly metabolic equivalent hours , on the basis of reported time spent on various activities , which we weighted according to intensity level ( 18 ) . The validity of self-reported weight ( 19 ) and physical activity ( 18 ) in this cohort has been reported previously . Ascertainment of Type 2 Diabetes Mellitus We mailed a supplementary question naire on symptoms , diagnostic tests , and medication use to participants who indicated on any biennial follow-up question naire that he had received a diagnosis of diabetes mellitus . Confirmation of diabetes required at least one of the following : 1 ) an elevated plasma glucose level ( fasting plasma glucose level 7.8 mmol/L [ 140 mg/dL ] ; r and om plasma glucose level 11.1 mmol/L [ 200 mg/dL ] ; or plasma glucose level after 2 hours or more during an oral glucose tolerance test 11.1 mmol/L [ 200 mg/dL ] ) plus at least one classic symptom [ excessive thirst , polyuria , weight loss , or hunger ] ; 2 ) at least two elevated plasma glucose levels measured on different occasions ; or 3 ) treatment with insulin or oral hypoglycemic medication . We excluded men who reported having type 1 diabetes on the supplementary question naire . These criteria for diabetes are consistent with those from the World Health Organization in 1985 ( 20 ) . We did not use the current diabetes classification of the American Diabetes Association ( 21 ) because among the men in our study , most cases of diabetes were diagnosed before these criteria were published . The validity of our assessment of type 2 diabetes was verified with medical records in a sub sample of 71 participants . A physician blinded to the information on the supplementary question naire review ed the records according to the diagnostic criteria . Of the 71 participants classified as having type 2 diabetes , 12 had incomplete medical recordsfor example , absent laboratory data ( n = 2 ) or only one set of laboratory data ( n = 9 ) . We confirmed the classification of type 2 diabetes in 57 ( 97 % ) of the other 59 other men in the sub sample . One participant denied having diabetes , and another participant lacked evidence of diabetes in his su bmi tted records . Statistical Analysis We used pooled logistic regression analyses with 2-year intervals to estimate the adjusted relative risk for each quintile compared with the lowest quintile of intake . With short time intervals and low rates of events , this approach gives results very similar to those of Cox proportional-hazards analyses ( 22 ) . Participants who died or received a diagnosis of diabetes during a 2-year cycle were censored at the end of that 2-year period and were not entered in any subsequent 2-year cycle . We used the cumulative average of available dietary assessment s up to the start of each 2-year follow-up interval ( 15 ) . We stopped updating a participant 's dietary",
"In animal models , a small ( catalytic ) dose of fructose administered with glucose decreases the glycemic response to the glucose load . Therefore , we examined the effect of fructose on glucose tolerance in 11 healthy human volunteers ( 5 men and 6 women ) . Each subject underwent an oral glucose tolerance test ( OGTT ) on 2 separate occasions , at least 1 week apart . Each OGTT consisted of 75 g glucose with or without 7.5 g fructose ( OGTT+F or OGTT-F ) , in r and om order . Arterialized blood sample s were obtained from a heated dorsal h and vein twice before ingestion of the carbohydrate and every 15 min for 2 h afterward . The area under the curve ( AUC ) of the change in plasma glucose was 19 % less in OGTT+F vs. OGTT-F ( P : Glucose tolerance was improved by fructose in 9 subjects and worsened in 2 . All 6 subjects with the largest glucose AUC during OGTT-F had a decreased response during OGTT+F ( 31 + /- 5 % decrease ) . The insulin AUC did not differ between the 2 studies . Of the 9 subjects with improved glucose tolerance during the OGTT+F , 5 had smaller insulin AUC during the OGTT+F than the OGTT-F. Plasma glucagon concentrations declined similarly during OGTT-F and OGTT+F. The blood lactate response was about 50 % greater during the OGTT+F ( P : nonesterified fatty acid nor triglyceride concentrations differed between the two OGTT . In conclusion , low dose fructose improves the glycemic response to an oral glucose load in normal adults without significantly enhancing the insulin or triglyceride response . Fructose appears most effective in those normal individuals who have the poorest glucose tolerance",
"CONTEXT Fructose-rich beverages such as sugar-sweetened soda and orange juice can increase serum uric acid levels and , thus , the risk of gout , but prospect i ve data on the relationship are limited . OBJECTIVE To examine the relationship between intake of fructose-rich beverages and fructose and the risk of incident gout among women . DESIGN , SETTING , AND PARTICIPANTS In the Nurses ' Health Study , a US prospect i ve cohort study spanning 22 years ( 1984 - 2006 ) , we analyzed data from 78,906 women with no history of gout at baseline who provided information on intake of beverages and fructose through vali date d food frequency question naires . MAIN OUTCOME MEASURE Incident cases that met the American College of Rheumatology survey criteria for gout . RESULTS During 22 years of follow-up , we documented 778 confirmed incident cases of gout . Increasing intake of sugar-sweetened soda was independently associated with increasing risk of gout . Compared with consumption of less than 1 serving per month of sugar-sweetened soda , the multivariate relative risk of gout for 1 serving per day was 1.74 ( 95 % confidence interval [ CI ] , 1.19 - 2.55 ) and for 2 or more servings per day was 2.39 ( 95 % CI , 1.34 - 4.26 ) ( P absolute risk differences corresponding to these relative risks were 36 and 68 cases per 100,000 person-years for sugar-sweetened soda and 14 and 47 cases per 100,000 person-years for orange juice , respectively . Diet soft drinks were not associated with the risk of gout ( P = .27 for trend ) . Compared with the lowest quintile of fructose intake , the multivariate relative risk of gout in the top quintile was 1.62 ( 95 % CI , 1.20 - 2.19 ; P = .004 for trend ) ( risk difference of 28 cases per 100,000 person-years ) . CONCLUSION Among this cohort of women , consumption of fructose-rich beverages is associated with an increased risk of incident gout , although the contribution of these beverages to the risk of gout in the population is likely modest given the low incidence rate among women",
"The long-term effects of sucrose on appetite and mood remain unclear . Normal weight subjects compensate for sucrose added blind to the diet ( Reid et al. , 2007 ) . Overweight subjects , however , may differ . In a single-blind , between-subjects design , soft drinks ( 4x25cl per day ; 1800kJ sucrose sweetened versus 67kJ aspartame sweetened ) were added to the diet of overweight women ( n=53 , BMI 25 - 30 , age 20 - 55 ) for 4 weeks . A 7-day food diary gave measures of total energy , carbohydrate , protein , fat , and micronutrients . Mood and hunger were measured by ten single Likert scales rated daily at 11.00 , 14.00 , 16.00 , and 20.00 . Activity levels were measured by diary and pedometer . Baseline energy intake did not differ between groups . During the first week of the intervention energy intake increased slightly in the sucrose group , but not in the aspartame group , then decreased again , so by the final week intake again did not differ from the aspartame group . Compensation was not large enough to produce significant changes in the composition of the voluntary diet . There were no effects on hunger or mood . It is concluded that overweight women do not respond adversely to sucrose added blind to the diet , but compensate for it by reducing voluntary energy intake . Alternative explanations for the correlation between sugary soft drink intake and weight gain are discussed",
"Background — Sugar-sweetened beverages ( SSBs ) are consumed globally and contribute to adiposity . However , the worldwide impact of SSBs on burdens of adiposity-related cardiovascular diseases ( CVDs ) , cancers , and diabetes mellitus has not been assessed by nation , age , and sex . Methods and Results — We modeled global , regional , and national burdens of disease associated with SSB consumption by age/sex in 2010 . Data on SSB consumption levels were pooled from national dietary surveys worldwide . The effects of SSB intake on body mass index and diabetes mellitus , and of elevated body mass index on CVD , diabetes mellitus , and cancers were derived from large prospect i ve cohort pooling studies . Disease-specific mortality/morbidity data were obtained from Global Burden of Diseases , Injuries , and Risk Factors 2010 Study . We computed cause-specific population -attributable fractions for SSB consumption , which were multiplied by cause-specific mortality/morbidity to compute estimates of SSB-attributable death/disability . Analyses were done by country/age/sex ; uncertainties of all input data were propagated into final estimates . Worldwide , the model estimated 184 000 ( 95 % uncertainty interval , 161 000–208 000 ) deaths/y attributable to SSB consumption : 133 000 ( 126 000–139 000 ) from diabetes mellitus , 45 000 ( 26 000–61 000 ) from CVD , and 6450 ( 4300–8600 ) from cancers . Five percent of SSB-related deaths occurred in low-income , 70.9 % in middle-income , and 24.1 % in high-income countries . Proportional mortality attributable to SSBs ranged from 65 years if age to 30 % in Mexicans disability-adjusted life years were related to SSB intake ( 4.5 % of diabetes mellitus – related disability-adjusted life years ) . Conclusions — SSBs are a single , modifiable component of diet that can impact preventable death/disability in adults in high- , middle- , and low-income countries , indicating an urgent need for strong global prevention programs",
"BACKGROUND Through the processes of oxidation , polymerization , and hydrogenation , the cooking method of frying modifies both foods and their frying medium . However , it remains unknown whether the frequent consumption of fried foods is related to long-term cardiometabolic health . OBJECTIVE We examined fried-food consumption and risk of developing incident type 2 diabetes ( T2D ) or coronary artery disease ( CAD ) . DESIGN Fried-food consumption was assessed by using a question naire in 70,842 women from the Nurses ' Health Study ( 1984 - 2010 ) and 40,789 men from the Health Professionals Follow-Up Study ( 1986 - 2010 ) who were free of diabetes , cardiovascular disease , and cancer at baseline . Time-dependent Cox proportional hazards models were used to estimate RRs and 95 % CIs for T2D and CAD adjusted for demographic , diet , lifestyle , and other cardiometabolic risk factors . Results were pooled by using an inverse variance-weighted r and om-effects meta- analysis . RESULTS We documented 10,323 incident T2D cases and 5778 incident CAD cases . Multivariate-adjusted RRs ( 95 % CIs ) for individuals who consumed fried foods Frequent fried-food consumption was significantly associated with risk of incident T2D and moderately with incident CAD , and these associations were largely mediated by body weight and comorbid hypertension and hypercholesterolemia"
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Abstract Objective : To systematic ally review and summarize the clinimetric properties , including reliability , validity , and responsiveness , the procedures used , and the meanings of the scores in the Timed Up and Go Test ( TUG ) . The TUG is a performance test that identifies problems with functional mobility in patients with stroke . Methods : MEDLINE and the Cochrane Central Register of Controlled Trials were search ed from 1991 to January 2013 . Studies were included if ( 1 ) the participants were adults with stroke ; ( 2 ) the research design was cross-sectional , descriptive , or longitudinal and examined the clinimetric properties , including reliability , validity , and sensitivity to change , and procedural differences in the TUG ; and ( 3 ) the study was published in English from 1991 to January 2013 . Results : Thirteen studies met the inclusion criteria . Of these , 4 showed the TUG to have good convergent validity , as it had significant correlations with various instruments . Three studies that investigated the test-retest reliability showed the TUG to have excellent intrarater and interrater reliability ( intraclass correlation coefficient [ ICC ] > 0.95 ) . The 3 studies that investigated whether the TUG could predict falls after stroke showed inconclusive results . Three studies showed the TUG to be sensitive to change , and 1 study showed the TUG to be responsive in moderate- and fast-walking patients with stroke . However , there were wide variations in the procedures and instructions used . Conclusion : The TUG can be recommended for measuring basic mobility skills after stroke in patients who are able to walk . However , the procedures and instructions should be described more clearly
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"OBJECTIVES To identify the most responsive method of measuring gait speed , to estimate the responsiveness of other outcome measures , and to determine whether gait speed predicts discharge destination in acute stroke . DESIGN A prospect i ve cohort study . SETTING Five acute-care hospitals . PATIENTS Fifty subjects with residual gait deficits after a first-time stroke . INTERVENTIONS Five- ( 5mWT ) and 10-meter walk tests ( 10mWT ) at comfortable and maximum speeds , with 2 evaluations conducted an average + /- st and ard deviation ( SD ) of 8 + /- 3 and 38 + /- 5 days poststroke . MAIN OUTCOME MEASURE St and ardized response mean ( SRM = mean change/SD of change ) was used to estimate responsiveness for each walk test , the Berg Balance Scale , the Barthel Index , the Stroke Rehabilitation Assessment of Movement ( STREAM ) , and the Timed Up and Go ( TUG ) . RESULTS The SRMs were 1.22 and 1.00 for the 5mWT , and .92 and .83 for the 10mWT performed at a comfortable and maximum pace , respectively . The SRMs for the Berg Balance Scale , the Barthel Index , the STREAM , and the TUG were 1.04,.99,.89 , and .73 , respectively . The probability of discharge to a rehabilitation center for persons walking at 0.6 m/s at the first evaluation was.95 and .22 , respectively . CONCLUSIONS The 5mWT at a comfortable pace is recommended as the measure of choice for clinicians and research ers who need to detect longitudinal change in walking disability in the first 5 weeks poststroke",
"OBJECTIVES To assess and compare the ability of the Timed Up & Go ( TUG ) and subscales of the Functional Autonomy Measurement System ( SMAF ) to detect change in people undergoing geriatric rehabilitation in inpatient geriatric rehabilitation units ( GRUs ) and day hospitals . DESIGN Longitudinal design with repeated measures obtained at admission and discharge from rehabilitation and at 2 follow-up interviews . SETTING Inpatient and outpatient hospital-based setting s. PARTICIPANTS Subjects ( N=237 , age 80+/-7 y ) had data at admission and discharge from rehabilitation ( changing time frame ) , and of these , 160 had data at 2 subsequent follow-ups ( stable time frame ) . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES The TUG was used to estimate basic mobility , and subscales of the SMAF were used to estimate general mobility ( SMAF-mobility ) , basic activities of daily living ( SMAF-ADL ) , and instrumental activities of daily living ( SMAF-IADL ) . Professionals ' perception of change was used as a criterion . RESULTS The TUG generated large values for the st and ardized response mean ( SRM ) and Guyatt 's responsiveness index in GRUs ( .98 and 1.12 ) and day hospitals ( .89 and 1.85 ) . Professionals ' perception of change in mobility was explained by a perceptible change in the TUG in day hospitals ( 15 % ) but not in GRUs . The SMAF-mobility , SMAF-ADL , and SMAF-IADL were associated with large values of SRM and Guyatt 's responsiveness index in GRUs ( .97 - 2.17 ) and with small to moderate values in day hospitals ( .29-.54 ) . Moderate to large portions in the professionals ' perceptions of change for mobility ( 20 % , 17 % ) , basic ADLs ( 10 % and 14 % ) , and IADLs ( 23 % and 19 % ) were associated with the respective change scores of the subscales of the SMAF in both GRUs and day hospitals . CONCLUSIONS Progress of older adults in the areas of mobility , basic ADLs , and IADLs can be captured using the TUG , SMAF-mobility , SMAF-ADL , and SMAF-IADL in both GRUs and day hospitals . The results support their use in setting s of high- and low-intensity rehabilitation , thus suggesting their adequacy for use in these 2 setting",
"OBJECTIVE To identify the effect of chair seat height and turning direction on the Timed Up and Go scores of patients after stroke . DESIGN A cross-sectional study . SETTING A geriatric day hospital in Hong Kong . SUBJECTS Twenty-five patients with sub-acute stroke . METHODS The time taken to complete the Timed Up and Go test with various chair seat heights ( 65 % , 90 % and 115 % of each subject 's leg length - distance from lateral knee joint line to ground in sitting ) and turning directions ( toward the affected and unaffected side ) was recorded using a stopwatch with r and omized test order . RESULTS There were significant differences in Timed Up and Go scores between the 3 levels of chair seat height ( p Timed Up and Go scores recorded when the seat height was 115 % of the subject 's leg length and the highest at a seat height of 65 % of the subject 's leg length . Turning toward the affected side was found to be significantly quicker than turning toward the unaffected side ( p seat height and turning direction significantly influence the Timed Up and Go scores of patients after sub-acute stroke . Optimizing chair seat height with reference to subject 's leg length and turning direction is essential when using the Timed Up and Go test as an outcome measure in stroke rehabilitation",
"Background The literature suggests that stroke is a major risk factor for falls , but there is a lack of prospect i ve , controlled studies which quantify fall-risk after stroke . The purpose of this study was to compare the rates , location and predictors among individuals recently discharged home from stroke rehabilitation to age and sex matched controls . Methodology /Principal Findings A sample of 80 people with stroke and 90 controls received baseline assessment s of balance , mobility and balance confidence . Falls were recorded prospect ively over 13 months for both groups . Group differences in fall rates and contribution of clinical measures to falls were determined using negative binomial regression . Fall location was compared between groups using χ2 statistics . The rate of falls for individuals with stroke was 1.77 times the rate for the control group . People with stroke were more likely to fall at home . Poorer balance ( Berg Balance Scale ) was associated with greater falls for both stroke and control groups ( incidence rate ratio [ IRR ] : 0.908 and IRR : 0.877 respectively ) . A faster Timed Up and Go Test was associated with greater falls for the stroke group ( IRR : 0.955 ) while better walking endurance ( Six Minute Walk Test ) was associated with greater falls for the controls ( IRR : 1.004 ) . Balance confidence was not an independent predictor in either group . Conclusions Individuals recently discharged home are at greater risk of falling than individuals without stroke . Attention to home environment is warranted . Balance function can predict falls for both people with stroke and age and sex matched controls . Increased mobility may increase exposure to fall opportunities",
"OBJECTIVES to evaluate and compare the prognostic validity relative to falls of the Timed Up- and -Go test ( TUG ) , a modified Get-Up- and -Go test ( GUG-m ) , staff 's judgement of global rating of fall risk ( GLORF ) and fall history among frail older people . DESIGN cohort study , 6-month prospect i ve follow-up for falls . PARTICIPANTS 183 frail persons living in residential care facilities in Sweden , mean age 84 years , 73 % women . METHODS the occurrence of falls during the follow-up period were compared to the following assessment s at baseline : the TUG at normal speed ; the GUG-m , a rating of fall risk scored from 1 ( no risk ) to 5 ( very high risk ) ; the GLORF , staff 's rating of fall risk as ' high ' or ' low ' ; a history of falls in the previous 6 months . These assessment tools were evaluated using sensitivity , specificity and positive and negative likelihood ratios ( LR(+ ) to rule in and LR(- ) to rule out a high fall risk ) . RESULTS 53 % of the participants fell at least once . Various cut-off values of the TUG ( 12 , 15 , 20 , 25 , 30 , 35 , 40 s ) and the GUG-m showed LR(+ ) between 0.9 and 2.6 and LR(- ) between 0.1 and 1.0 . The GLORF showed an LR(+ ) of 2.8 and an LR(- ) of 0.6 and fall history showed an LR(+ ) of 2.4 and an LR(- ) of 0.6 . CONCLUSIONS in this population of frail older people , staff judgement of their residents ' fall risk as well as previous falls both appear superior to the performance-based measures TUG and GUG-m in ruling in a high fall risk . A TUG score of less than 15 s gives guidance in ruling out a high fall risk but insufficient information in ruling in such a risk . The grading of fall risk by GUG-m appears of very limited value",
"OBJECTIVE To assess the likelihood of clinical tests for postural balance , walking and motor skills , performed during the first week after stroke , identifying the risk of falling . DESIGN Prospect i ve study . SUBJECTS Patients with first stroke . METHODS Assessment s were carried out during the first week , and the occurrence of falls was recorded 3 , 6 and 12 months after stroke onset . The tests used were : 10-Metre Walking Test ( 10MWT ) , Timed Up & Go , Swedish Postural Assessment Scale for Stroke Patients , Berg Balance Scale and Modified Motor Assessment Scale . Cut-off levels were obtained by receiver operation characteristic curves , and odds ratios were used to assess cut-off levels for falling . RESULTS The analyses were based on 96 patients . Forty-eight percent had at least one fall during the first year . All tests were associated with the risk of falling . The highest predictive values were found for the 10MWT ( positive predictive value 64 % , negative predictive value 76 % ) . Those subjects who were unable to perform the 10MWT had the highest odds ratio , 6.06 ( 95 % confidence interval 2.66 - 13.84 , p Clinical tests used during the first week after stroke onset can , to some extent , identify those patients at risk of falling during the first year after stroke",
"BACKGROUND AND PURPOSE Patients with neurological disorders , including post-stroke patients , are at high risk for falls . The purpose of the study was to estimate the number and type of falls and fall-related injuries in patients of a neurological rehabilitation ward and to identify risk factors for falls . MATERIAL AND METHODS 353 consecutive post-stroke patients of the Neurorehabilitation Unit at the Institute of Psychiatry and Neurology in Warsaw were enrolled into the study and observed during the hospital stay . Falls occurring in patients during their hospital stay were registered and an analysis of fall-related data and the routinely obtained medical data was performed . RESULTS In the evaluated group , 35 ( 10 % ) patients suffered 50 falls , which corresponds to an incidence rate of 5.02 [ 95 % confidence interval ( 95 % CI ) : 3.70 - 6.52 ] falls per 1000 patient-days . Most falls occurred in patients ' rooms ( 80 % ) , most of them taking place while transferring from one place to another or while changing position . 2 % of falls caused severe injury . There was a higher percentage of patients with unilateral neglect in the group of fallers ( p=0.0007 ) , who also demonstrated poorer performance in activities of daily living as expressed by the Rankin score ( p Barthel Index ( p greater neurological deficit in the Sc and inavian Stroke Scale ( SSS ) ( p=0.002 ) at admission as well as at discharge from hospital than non-fallers . The risk of a fall showed greatest association with low Barthel Index at admission ( performance in the Rankin score of > 3 ( RR=5.12 ; 95 % CI : 2,41 - 14,8 ) , low SSS score on admission ( 0 - 39 ; RR=3.40 ; 95 % CI : 1.62 - 9.14 ) , and the presence of hemispatial neglect ( RR=3.42 ; 95 % CI : 1.23 - 6.53 ) . The multiple-fallers group did not differ significantly from the group of single-fallers . CONCLUSIONS Among post-stroke patients , falls are a complication especially affecting persons with a large neurological deficit , severe disability and the neglect syndrome",
"Abstract Purpose : To compare the Timed Up & Go ( TUG ) test between subjects with and without hemiparesis , considering the direction toward which they turned , and to determine the potential clinical variables that could explain possible observed differences between the groups and /or the turning directions . Method : Twenty-two hemiparetic and 22 matched control subjects performed the TUG twice , with each one turning in both directions . Measures of the strength and tonus of the quadriceps , gait speed , balance , and fear of falling were also collected . Results : Stroke subjects were slower in the TUG than the control group , independent of the direction toward which they turned ( F = 45.87 ; p performances were observed when turning toward the paretic and nonparetic/matched sides ( F = 0.50 ; p = .48 ) . The absolute differences between the two TUG trials were greater for the stroke subjects ( p = .001 ) and were significantly correlated with gait speed , balance , and fear of falling ( −0.69 fear of falling being the only variable retained in the regression model ( R2 = 0.44 ; p = .001 ) . For the control subjects , no significant correlations were found . Conclusions : The larger differences between the two TUG trials for the stroke subjects illustrated the impact of the turning direction on test performance . These differences were not related to hemiparesis , but to the fear of falling",
"OBJECTIVE To test the effects of the use of a collapsible , portable chair ( chair B ) , as opposed to a ' st and ard ' chair ( chair A ) , on the outcome of the timed \" Up and Go \" ( TUG ) test . DESIGN Cross-sectional . SETTING Multi purpose senior centres . PARTICIPANTS Mobile older persons ( N=118 , mean age 77 years ( range 62 - 99 years ) ) . OUTCOME MEASURES Time to complete the timed \" Up and Go \" test using chair A and chair B , and inter-rater agreement in the time scores . RESULTS Time taken to complete the TUG test did not differ by chair type [ median ( interquartile range , IQR ) = 12.3 ( 9.53 - 15.9 ) and 12.6 ( 9.7 - 16.6 ) ] seconds for Chair A and B respectively , p-value=0.87 . In multiple regression analyses , factors that impacted on time difference in test performance for the two chairs were use of a walking aid during the test [ Odds ratio ( OR ) = 3.7 95%CI 1.1 - 11.9 , p=0.031 ] , observed difficulty with mobility ( OR= 27.7 95%CI 2.6 - 290 , p=0.006 ) , and a history of arthritis in the knees ( OR= 2.9 95%CI 1.0 - 8.7 , P=0.05 ) . In an inter-rater agreement analysis , no significant difference was found between time scores recorded by the two raters ; median ( IQR ) = 12.4 ( 10.9 - 15.9 ) and 12.3 ( 7.2 - 59.1 ) seconds for the occupation therapist and for the research assistant , respectively ( Wilcoxon matched pairs test , p=0.124 , Spearman correlation coefficient = 0.99 , p portable canvas chair with st and ardised specifications offers an acceptable alternative to the use of a ' st and ard ' chair in assessment s of fall risk using the TUG test in field setting s where field workers are reliant on public transport"
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4118264c-06ff-11f0-808a-c43d1ab1c353
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Summary Aims The aim of this non‐ systematic review was to provide a practical guide for clinicians on the evidence for central sensitisation in chronic osteoarthritis ( OA ) pain and how this pain mechanism can be addressed in terms of clinical diagnosis , investigation and treatment . Methods The authors undertook a non‐ systematic review of the literature including a MEDLINE search ( search terms included central sensitisation , osteoarthritis , osteoarthrosis ) for relevant and current clinical studies , systematic review s and narrative review s. Case reports , letters to the editor and similar literature sources were excluded . Information was organised to allow a pragmatic approach to the discussion of the evidence and generation of practical recommendations . Results There is good evidence for a role of central sensitisation in chronic OA pain in a subgroup of patients . Clinical ly , a central sensitisation component in chronic OA pain can be suspected based on characteristic pain features and non‐pain features seen in other conditions involving central sensitisation . However , there are currently no diagnostic inventories for central sensitisation specific to OA . Biomarkers may be helpful for confirming the presence of central sensitisation , especially when there is diagnostic uncertainty . Several non‐pharmacological and pharmacological treatments may be effective in OA patients with central sensitisation features . Multimodal therapy may be required to achieve control of symptoms . Discussion Clinicians should be aware of central sensitisation in patients with chronic OA pain , especially in patients presenting with severe pain with unusual features
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[
"Purpose Osteoarthritic pain is largely considered to be inflammatory pain . Sensory nerve fibers innervating the knee have been shown to be significantly damaged in rat models of knee osteoarthritis ( OA ) in which the subchondral bone junction is destroyed , and this induces neuropathic pain ( NP ) . Pregabalin was developed as a pain killer for NP ; however , there are no reports on pregabalin use in OA patients . The purpose of this study was to investigate the efficacy of pregabalin for pain in OA patients . Material s and Methods Eighty-nine knee OA patients were evaluated in this r and omized prospect i ve study . Patients were divided into meloxicam , pregabalin , and meloxicam+pregabalin groups . Pain scores were evaluated before and 4 weeks after drug application using a visual analogue scale ( VAS ) , and Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . Pain scales among groups were compared using a Kruskal-Wallis test . Results Before drug application , there was no significant difference in VAS and WOMAC scores among the three groups ( p>0.05 ) . Significant pain relief was seen in the meloxicam+pregabalin group in VAS at 1 , 2 , and 4 weeks , and WOMAC score at 4 weeks , compared with the other groups ( p significant pain relief was seen in the meloxicam only group in VAS during 4 weeks and WOMAC score at 4 weeks compared with the pregabalin only group ( p>0.05 ) . Conclusion Meloxicam+pregabalin was effective for pain in OA patients . This finding suggests that OA pain is a combination of inflammatory and NP",
"Background Tapentadol prolonged release ( PR ; 100–250 mg twice daily ) has been efficacious and well tolerated for managing moderate-to-severe , chronic osteoarthritis hip or knee pain in phase 3 studies with washout of previous analgesic treatment . Objective The objective of this study was to evaluate the effectiveness and tolerability of tapentadol PR ( 50–250 mg twice daily ) after direct rotation from World Health Organization ( WHO ) step III opioids in patients with severe osteoarthritis knee pain who previously responded to WHO step III therapy but showed poor tolerability . Methods This open-label , phase 3b study ( NCT00982280 ) was conducted from October 2009 through June 2010 ( prematurely terminated due to slow recruitment and study drug shortages ) in clinical care setting s in Europe and Australia . The study population included patients with severe , chronic osteoarthritis knee pain who had taken WHO step III opioids daily for ≥2 weeks before screening , responded to therapy ( average pain intensity [ 11-point numerical rating scale-3 ( NRS-3 ) ] ≤5 at screening ) , and reported opioid-related adverse effects as their reason for changing analgesics . Patients switched directly from WHO step III therapy to tapentadol . Patients received oral tapentadol PR ( 50–250 mg twice daily ) during 5-week titration and 7-week maintenance periods . Oral tapentadol immediate release ( IR ) was permitted ( ≤twice/day , ≥4 h apart ) for acute pain episodes due to index pain or withdrawal symptoms following discontinuation of previous opioids ( combined dose of tapentadol [ PR and IR ] ≤500 mg/day ) . This study was planned to evaluate conversion to tapentadol PR , based on responder rate 1 ( percentage of patients with same/less pain [ NRS-3 ] versus Week −1 ) at Week 6 ( primary endpoint ) , adverse events ( AEs ) , and discontinuation rates . Equianalgesic ratios were calculated for tapentadol prior to WHO step III opioids ( PR and PR plus IR formulations ) . Results Of 82 patients enrolled , 63 received study medication . In the per- protocol population , responder rate 1 at Week 6 ( last observation carried forward ) was 94.3 % ( 50/53 ; P scores were 4.7 ( 0.66 ) at baseline , 2.5 ( 1.46 ) at Week 6 , and 1.8 ( 1.41 ) at Week 12 in the main analysis population ( change from baseline at Weeks 6 and 12 , P Tapentadol to transdermal buprenorphine equianalgesic ratios ( PR [ n = 48 ] , 262.9:1 ; PR plus IR [ n = 48 ] , 281.1:1 ) and tapentadol to oral oxycodone equianalgesic ratios ( PR [ n = 4 ] , 4.3:1 ; PR plus IR [ n = 6 ] , 4.6:1 ) were calculated for the main analysis population . In the safety population , prevalence of AEs reported as associated with prior opioids at Week −1 ( reasons for rotation ) and related to tapentadol treatment at Week 12 decreased over time ; the most common were nausea ( 46.0 vs. 24.1 % ) and constipation ( 31.7 vs. 7.4 % ) . Overall , 14.3 % of patients discontinued the study early ; reasons included AEs ( 9.5 % ) , lack of efficacy ( 3.2 % ) , and withdrawal of consent ( 1.6 % ) . Conclusions Significant improvements in effectiveness were observed for tapentadol PR ( 50–250 mg twice daily ) versus WHO step III opioids in patients with severe , chronic osteoarthritis knee pain who previously responded to WHO step III therapy . Equianalgesic ratios were calculated for tapentadol to transdermal buprenorphine and oral oxycodone and were in line with observations from previous phase 3 studies",
"Abstract Objective : To determine the efficacy , tolerability , and safety of duloxetine when added to oral nonsteroidal anti-inflammatory drugs ( NSAIDs ) in patients with osteoarthritis ( OA ) of the knee with pain of moderate or greater severity . Research design and methods : This was a 10-week r and omized , double-blind , flexible-dose ( duloxetine 60/120 mg/day ) , placebo-controlled trial that enrolled adult out patients who had persistent moderate pain ( ≥4 on a 0–10 numerical rating scale ) due to OA of the knee , despite , per protocol , having received optimized oral NSAID therapy ( specific drug , dose , and frequency at investigator discretion ) . Clinical trials registration : Trial registration : Clinical Trials.gov identifier : NCT01018680 . Main outcome measure : Patients entered daily pain ratings in a telephone-based diary . The primary efficacy outcome was the weekly mean of the daily average pain rating at week 8 . Safety outcomes were assessed during the entire 10-week study . Results : A total of 524 patients r and omly received duloxetine 60/120 mg/day ( N = 264 ) or placebo ( N = 260 ) . In total , 74 % of the patients completed the study . Mean age was 61 years ( SD 9.2 ) , 57 % were female , and 81 % were white . Duloxetine-treated patients had significantly greater pain reduction at week 8 ( p to placebo at week 8 , duloxetine-treated patients had significant improvements in physical function as measured by the Western Ontario and McMaster Universities Osteoarthritis Index ( p and Patient Global Impression of Improvement ( p Compared to placebo , significantly more nausea , dry mouth , constipation , fatigue and decreased appetite were reported by patients taking duloxetine ( each p to adverse events occurred more commonly in the duloxetine group than the placebo group ( p = 0.03 ) . Conclusion : Duloxetine added to oral NSAID therapy provided additional significant pain reduction , improved function , and patient-rated impression of improvement . Adverse events were consistent with those seen in previous duloxetine trials . The short duration of the study may not reflect the longer term efficacy and safety of NSAID/duloxetine cotherapy",
"OBJECTIVE To evaluate the efficacy and safety of duloxetine in the treatment of chronic pain due to osteoarthritis of the knee . METHODS This was a 13-week , r and omized , double-blind , placebo-controlled trial in patients meeting American College of Rheumatology clinical and radiographic criteria for osteoarthritis of the knee . At baseline , patients were required to have a ≥ 4 weekly mean of the 24-hour average pain ratings . Patients were r and omized to either duloxetine 60 mg once daily ( QD ) or placebo . At week 7 , the duloxetine dosage was increased , in a blinded fashion , to 120-mg QD in patients reporting was Brief Pain Inventory ( BPI ) 24-hour average pain . Secondary efficacy measures included Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) ; Clinical Global Impressions of Severity ( CGI-S ) . Safety and tolerability was also assessed . RESULTS Of the total ( n = 256 ) patients , 111 ( 86.7 % ) in placebo group and 93 ( 72.7 % ) in duloxetine group completed the study . Patients treated with duloxetine had significantly ( P ≤ 0.001 ) greater improvement at all time points on BPI average pain and had significantly greater improvement on BPI pain severity ratings ( P ≤ 0.05 ) , WOMAC total ( P = 0.044 ) and physical functioning scores ( P = 0.016 ) , and CGI-S ( P = 0.009 ) at the study endpoint . Frequency of treatment-emergent nausea , constipation , and hyperhidrosis were significantly higher in the duloxetine group ( P ≤ 0.05 ) . Significantly more duloxetine-treated patients discontinued the trial because of adverse events ( P = 0.002 ) . CONCLUSIONS Treatment with duloxetine 60 mg to 120 mg QD was associated with significant pain reduction and improved function in patients with pain due to osteoarthritis of the knee"
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411826ce-06ff-11f0-808a-c43d1ab1c353
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Summary Neurofeedback ( NF ) is a training to enhance self-regulatory capacity over brain activity patterns and consequently over brain mental states . Recent findings suggest that NF is a promising alternative for the treatment of attention-deficit/hyperactivity disorder ( ADHD ) . We comprehensively review ed literature search ing for studies on the effectiveness and specificity of NF for the treatment of ADHD . In addition , clinical ly informative evidence -based data are discussed . We found 3 systematic review on the use of NF for ADHD and 6 r and omized controlled trials that have not been included in these review s. Most nonr and omized controlled trials found positive results with medium-to-large effect sizes , but the evidence for effectiveness are less robust when only r and omized controlled studies are considered . The direct comparison of NF and sham-NF in 3 published studies have found no group differences , nevertheless method ological caveats , such as the quality of the training protocol used , sample size , and sample selection may have contributed to the negative results . Further data on specificity comes from electrophysiological studies reporting that NF effectively changes brain activity patterns . No safety issues have emerged from clinical trials and NF seems to be well tolerated and accepted . Follow-up studies support long-term effects of NF . Currently there is no available data to guide clinicians on the predictors of response to NF and on optimal treatment protocol . In conclusion , NF is a valid option for the treatment for ADHD , but further evidence is required to guide its use
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"Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with attention-deficit/hyperactivity disorder ( ADHD ) in several , mostly uncontrolled studies . This pilot study is design ed to test the feasibility and safety of using a double-blind placebo feedback-controlled design and to explore the initial efficacy of individualized EEG-neurofeedback training in children with ADHD . Fourteen children ( 8–15 years ) with ADHD defined according to the DSM-IV-TR criteria were r and omly allocated to 30 sessions of EEG-neurofeedback ( n = 8) or placebo feedback ( n = 6 ) . Safety measures ( adverse events and sleep problems ) , ADHD symptoms and global improvement were monitored . With respect to feasibility , all children completed the study and attended all study visits and training sessions . No significant adverse effects or sleep problems were reported . Regarding the expectancy , 75 % of children and their parent(s ) in the active neurofeedback group and 50 % of children and their parent(s ) in the placebo feedback group thought they received placebo feedback training . Analyses revealed significant improvements of ADHD symptoms over time , but changes were similar for both groups . This pilot study shows that it is feasible to conduct a rigorous placebo-controlled trial to investigate the efficacy of neurofeedback training in children with ADHD . However , a double-blind design may not be feasible since using automatic adjusted reward thresholds may not work as effective as manually adjusted reward thresholds . Additionally , implementation of active learning strategies may be an important factor for the efficacy of EEG-neurofeedback training . Based on the results of this pilot study , changes are made in the design of the ongoing study",
"Neurofeedback treatment has been demonstrated to reduce inattention , impulsivity and hyperactivity in children with attention deficit/hyperactivity disorder ( ADHD ) . However , previous studies did not adequately control confounding variables or did not employ a r and omized reinforcer-controlled design . This study addresses those method ological shortcomings by comparing the effects of the following two matched biofeedback training variants on the primary symptoms of ADHD : EEG neurofeedback ( NF ) aim ing at theta/beta ratio reduction and EMG biofeedback ( BF ) aim ing at forehead muscle relaxation . Thirty-five children with ADHD ( 26 boys , 9 girls ; 6–14 years old ) were r and omly assigned to either the therapy group ( NF ; n = 18 ) or the control group ( BF ; n = 17 ) . Treatment for both groups consisted of 30 sessions . Pre- and post-treatment assessment consisted of psychophysiological measures , behavioural rating scales completed by parents and teachers , as well as psychometric measures . Training effectively reduced theta/beta ratios and EMG levels in the NF and BF groups , respectively . Parents reported significant reductions in primary ADHD symptoms , and inattention improvements in the NF group were higher compared to the control intervention ( BF , dcorr = −.94 ) . NF training also improved attention and reaction times on the psychometric measures . The results indicate that NF effectively reduced inattention symptoms on parent rating scales and reaction time in neuropsychological tests . However , regarding hyperactivity and impulsivity symptoms , the results imply that non-specific factors , such as behavioural contingencies , self-efficacy , structured learning environment and feed-forward processes , may also contribute to the positive behavioural effects induced by neurofeedback training",
"Objective : Preparing for a definitive r and omized clinical trial ( RCT ) of neurofeedback ( NF ) for ADHD , this pilot trial explored feasibility of a double-blind , sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week . Method : Unmedicated 6- to 12-year-olds with Diagnostic and Statistical Manual of Mental Disorders ( 4th ed . ; DSM-IV ) ADHD were r and omized to active NF versus sham-NF and to 2X versus 3X/week treatment frequency . Frequency switch was allowed after Treatment 24 . Results : In two school years , 39 participants were recruited and 34 ( 87 % ) completed all 40 treatments . Child/parent guesses about assigned treatment were no better than chance . At Treatment 24 , 38 % chose 2X/week and 62 % chose 3X/week . Both active NF and sham yielded large pre – post improvement on parent ratings but NF no more than sham . Conclusion : Blinding appears to work , and sham does not prevent recruitment/retention . Treatment frequency of 3X/week seems preferred over 2X/week and was as effective . A large double-blind RCT is feasible and necessary to test specific NF effectiveness",
"Neurofeedback ( NF ) could help to improve attentional and self-management capabilities in children with attention-deficit/hyperactivity disorder ( ADHD ) . In a r and omised controlled trial , NF training was found to be superior to a computerised attention skills training ( AST ) ( Gevensleben et al. in J Child Psychol Psychiatry 50(7):780–789 , 2009 ) . In the present paper , treatment effects at 6-month follow-up were studied . 94 children with ADHD , aged 8–12 years , completed either 36 sessions of NF training ( n = 59 ) or a computerised AST ( n = 35 ) . Pre-training , post-training and follow-up assessment encompassed several behaviour rating scales ( e.g. , the German ADHD rating scale , FBB-HKS ) completed by parents . Follow-up information was analysed in 61 children ( ca . 65 % ) on a per- protocol basis . 17 children ( of 33 dropouts ) had started a medication after the end of the training or early in the follow-up period . Improvements in the NF group ( n = 38 ) at follow-up were superior to those of the control group ( n = 23 ) and comparable to the effects at the end of the training . For the FBB-HKS total score ( primary outcome measure ) , a medium effect size of 0.71 was obtained at follow-up . A reduction of at least 25 % in the primary outcome measure ( responder criterion ) was observed in 50 % of the children in the NF group . In conclusion , behavioural improvements induced by NF training in children with ADHD were maintained at a 6-month follow-up . Though treatment effects appear to be limited , the results confirm the notion that NF is a clinical ly efficacious module in the treatment of children with ADHD",
"Two functional magnetic resonance imaging ( fMRI ) experiments were undertaken to measure the effect of neurofeedback training ( NFT ) , in AD/HD children , on the neural substrates of selective attention and response inhibition . Twenty unmedicated AD/HD children participated to these experiments . Fifteen children were r and omly assigned to the Experimental ( EXP ) group whereas the other five children were r and omly assigned to the Control ( CON ) group . Only subjects in the EXP group underwent NFT . EXP subjects were trained to enhance the amplitude of the SMR ( 12–15 Hz ) and beta 1 activity ( 15–18 Hz ) , and decrease the amplitude of theta activity ( 4–7 Hz ) . Subjects from both groups were scanned one week before the beginning of NFT ( Time 1 ) and 1 week after the end of NFT ( Time 2 ) , while they performed a “ Counting Stroop ” task ( Experiment 1 ) and a Go/No-Go task ( Experiment 2 ) . At Time 1 , in both groups , the Counting Stroop task was associated with significant activation in the left superior parietal lobule . For the Go/No-Go task , no significant activity was detected in the EXP and CON groups . At Time 2 , in both groups , the Counting Stroop task was associated with significant activation of the left superior parietal lobule . This time , however , there were significant loci of activation , in the EXP group , in the right ACC , left cau date nucleus , and left substantia nigra . No such activation loci were seen in CON subjects . For the Go/No-Go task , significant loci of activation were noted , in the EXP group , in the right ventrolateral prefrontal cortex , right ACcd , left thalamus , left cau date nucleus , and left substantia nigra . No significant activation of these brain regions was measured in CON subjects . These results suggest that NFT has the capacity to functionally normalize the brain systems mediating selective attention and response inhibition in AD/HD children",
"OBJECTIVES To determine any long-term effects , 6 and 8 years after childhood enrollment , of the r and omly assigned 14-month treatments in the NIMH Collaborative Multisite Multimodal Treatment Study of Children With Attention-Deficit/Hyperactivity Disorder ( MTA ; N = 436 ) ; to test whether attention-deficit/hyperactivity disorder ( ADHD ) symptom trajectory through 3 years predicts outcome in subsequent years ; and to examine functioning level of the MTA adolescents relative to their non-ADHD peers ( local normative comparison group ; N = 261 ) . METHOD Mixed-effects regression models with planned contrasts at 6 and 8 years tested a wide range of symptom and impairment variables assessed by parent , teacher , and youth report . RESULTS In nearly every analysis , the originally r and omized treatment groups did not differ significantly on repeated measures or newly analyzed variables ( e.g. , grade s earned in school , arrests , psychiatric hospitalizations , other clinical ly relevant outcomes ) . Medication use decreased by 62 % after the 14-month controlled trial , but adjusting for this did not change the results . ADHD symptom trajectory in the first 3 years predicted 55 % of the outcomes . The MTA participants fared worse than the local normative comparison group on 91 % of the variables tested . CONCLUSIONS Type or intensity of 14 months of treatment for ADHD in childhood ( at age 7.0 - 9.9 years ) does not predict functioning 6 to 8 years later . Rather , early ADHD symptom trajectory regardless of treatment type is prognostic . This finding implies that children with behavioral and sociodemographic advantage , with the best response to any treatment , will have the best long-term prognosis . As a group , however , despite initial symptom improvement during treatment that is largely maintained after treatment , children with combined-type ADHD exhibit significant impairment in adolescence . Innovative treatment approaches targeting specific areas of adolescent impairment are needed",
"Clinical trials have suggested that neurofeedback may be efficient in treating attention-deficit/hyperactivity disorder ( ADHD ) . We compared the effects of a 3-month electroencephalographic feedback program providing reinforcement contingent on the production of cortical sensorimotor rhythm ( 12–15 Hz ) and beta1 activity ( 15–18 Hz ) with stimulant medication . Participants were N = 34 children aged 8–12 years , 22 of which were assigned to the neurofeedback group and 12 to the methylpheni date group according to their parents ' preference . Both neurofeedback and methylpheni date were associated with improvements on all subscales of the Test of Variables of Attention , and on the speed and accuracy measures of the d2 Attention Endurance Test . Furthermore , behaviors related to the disorder were rated as significantly reduced in both groups by both teachers and parents on the IOWA-Conners Behavior Rating Scale . These findings suggest that neurofeedback was efficient in improving some of the behavioral concomitants of ADHD in children whose parents favored a nonpharmacological treatment",
"Attention Deficit Hyperactivity Disorder ( AD/HD ) is a neurodevelopmental disorder mainly characterized by impairments in cognitive functions . Functional neuroimaging studies carried out in individuals with AD/HD have shown abnormal functioning of the anterior cingulate cortex ( ACC ) during tasks involving selective attention . In other respects , there is mounting evidence that neurofeedback training ( NFT ) can significantly improve cognitive functioning in AD/HD children . In this context , the present functional magnetic resonance imaging ( fMRI ) study was conducted to measure the effect of NFT on the neural substrates of selective attention in children with AD/HD . Twenty AD/HD children -- not taking any psychostimulant and without co-morbidity-participated to the study . Fifteen children were r and omly assigned to the Experimental ( EXP ) group ( NFT ) , whereas the other five children were assigned to the Control ( CON ) group ( no NFT ) . Subjects from both groups were scanned 1 week before the beginning of the NFT ( Time 1 ) and 1 week after the end of this training ( Time 2 ) , while they performed a Counting Stroop task . At Time 1 , for both groups , the Counting Stroop task was associated with significant loci of activation in the left superior parietal lobule . No activation was noted in the ACC . At Time 2 , for both groups , the Counting Stroop task was still associated with significant activation of the left superior parietal lobule . This time , however , for the EXP group only there was a significant activation of the right ACC . These results suggest that in AD/HD children , NFT has the capacity to normalize the functioning of the ACC , the key neural substrate of selective attention",
"BACKGROUND For children with attention deficit/hyperactivity disorder ( ADHD ) , a reduction of inattention , impulsivity and hyperactivity by neurofeedback ( NF ) has been reported in several studies . But so far , unspecific training effects have not been adequately controlled for and /or studies do not provide sufficient statistical power . To overcome these method ological shortcomings we evaluated the clinical efficacy of neurofeedback in children with ADHD in a multisite r and omised controlled study using a computerised attention skills training as a control condition . METHODS 102 children with ADHD , aged 8 to 12 years , participated in the study . Children performed either 36 sessions of NF training or a computerised attention skills training within two blocks of about four weeks each ( r and omised group assignment ) . The combined NF treatment consisted of one block of theta/beta training and one block of slow cortical potential ( SCP ) training . Pre-training , intermediate and post-training assessment encompassed several behaviour rating scales ( e.g. , the German ADHD rating scale , FBB-HKS ) completed by parents and teachers . Evaluation ( ' placebo ' ) scales were applied to control for parental expectations and satisfaction with the treatment . RESULTS For parent and teacher ratings , improvements in the NF group were superior to those of the control group . For the parent-rated FBB-HKS total score ( primary outcome measure ) , the effect size was .60 . Comparable effects were obtained for the two NF protocol s ( theta/beta training , SCP training ) . Parental attitude towards the treatment did not differ between NF and control group . CONCLUSIONS Superiority of the combined NF training indicates clinical efficacy of NF in children with ADHD . Future studies should further address the specificity of effects and how to optimise the benefit of NF as treatment module for ADHD",
"This study examines the efficacy of neurofeedback training in the cognitive division of the anterior cingulate gyrus and describes its relationship with cortical regions known to be involved in executive functions . This study was conducted with eight non- clinical students , four male and four female , with a mean age of twenty-two . Learning occurred in the ACcd at significant levels over sessions and in the anterior regions that receive projections from the AC . There appears to be a multidimensional executive circuit that increases in the same frequency in apparent synchrony with the AC and it may be possible to train this sub-cortical region using LNFB",
"BACKGROUND Learned self-control of slow cortical potentials ( SCPs ) may lead to behavioral improvement in attention-deficit/hyperactivity disorder ( ADHD ) . Hence , training effects should also be reflected at the neurophysiological level . METHODS Thirteen children with ADHD , aged 7 - 13 years , performed 25 SCP training sessions within 3 weeks . Before and after training , the German ADHD rating scale was completed by parents , and event-related potentials were recorded in a cued continuous performance test ( CPT ) . For a waiting-list group of nine children with ADHD , the same testing was applied . RESULTS ADHD symptomatology was reduced by approximately 25 % after SCP training . Moreover , a decrease of impulsivity errors and an increase of the contingent negative variation were observed in the CPT task . CONCLUSIONS This study provides first evidence for both positive behavioral and specific neurophysiological effects of SCP training in children with ADHD",
"One hundred children , ages 6–19 , who were diagnosed with attention-deficit/hyperactivity disorder ( ADHD ) , either inattentive or combined types , participated in a study examining the effects of Ritalin , EEG biofeedback , and parenting style on the primary symptoms of ADHD . All of the patients participated in a 1-year , multimodal , outpatient program that included Ritalin , parent counseling , and academic support at school ( either a 504 Plan or an IEP ) . Fifty-one of the participants also received EEG biofeedback therapy . Posttreatment assessment s were conducted both with and without stimulant therapy . Significant improvement was noted on the Test of Variables of Attention ( TOVA ; L. M. Greenberg , 1996 ) and the Attention Deficit Disorders Evaluation Scale ( ADDES ; S. B. McCarney , 1995 ) when participants were tested while using Ritalin . However , only those who had received EEG biofeedback sustained these gains when tested without Ritalin . The results of a Quantitative Electroencephalographic Scanning Process ( QEEG-Scan ; V. J. Monastra et al. , 1999 ) revealed significant reduction in cortical slowing only in patients who had received EEG biofeedback . Behavioral measures indicated that parenting style exerted a significant moderating effect on the expression of behavioral symptoms at home but not at school",
"This study replicated T. R. Rossiter and T. J. La Vaque ( 1995 ) with a larger sample , exp and ed age range , and improved statistical analysis . Thirty-one AD/HD patients who chose stimulant drug ( MED ) treatment were matched with 31 patients who chose a neurofeedback ( EEG ) treatment program . EEG patients received either office ( n = 14 ) or home ( n = 17 ) neurofeedback . Stimulants for MED patients were titrated using the Test of Variables of Attention ( TOVA ) . EEG ( effect size [ ES ] = 1.01–1.71 ) and MED ( ES = 0.80–1.80 ) groups showed statistically and clinical ly significant improvement on TOVA measures of attention , impulse control , processing speed , and variability in attention . The EEG group demonstrated statistically and clinical ly significant improvement on behavioral measures ( Behavior Assessment System for Children , ES = 1.16–1.78 , and Brown Attention Deficit Disorder Scales , ES = 1.59 ) . TOVA gain scores for the EEG and MED groups were not significantly different . More importantly , confidence interval and nonequivalence None hypothesis testing confirmed that the neurofeedback program produced patient outcomes equivalent to those obtained with stimulant drugs . An effectiveness research design places some limitations on the conclusions that can be drawn",
"Insomnia is a sleeping disorder , usually studied from a behavioural perspective , with a focus on somatic and cognitive arousal . Recent studies have suggested that an impairment of information processes due to the presence of cortical hyperarousal might interfere with normal sleep onset and /or consolidation . As such , a treatment modality focussing on CNS arousal , and thus influencing information processing , might be of interest . Seventien insomnia patients were r and omly assigned to either a tele-neurofeedback ( n = 9 ) or an electromyography tele-biofeedback ( n = 8) protocol . Twelve healthy controls were used to compare baseline sleep measures . A polysomnography was performed pre and post treatment . Total Sleep Time ( TST ) , was considered as our primary outcome variable . Sleep latency decreased pre to post treatment in both groups , but a significant improvement in TST was found only after the neurofeedback ( NFB ) protocol . Furthermore , sleep logs at home showed an overall improvement only in the neurofeedback group , whereas the sleep logs in the lab remained the same pre to post training . Only NFB training result ed in an increase in TST . The mixed results concerning perception of sleep might be related to method ological issues , such as the different locations of the training and sleep measurements",
"We design ed a r and omized , rater blind study to assess the efficacy of EEG Biofeedback ( Neurofeedback-NFB ) in patients with fibromyalgia syndrome ( FMS ) . Eighteen patients received twenty sessions of NFB-sensory motor rhythm ( SMR ) treatment ( NFB group ) during 4 weeks , and eighteen patients were given 10 mg per day escitalopram treatment ( control group ) for 8 weeks . Visual Analog Scales for pain and fatigue , Hamilton and Beck Depression and Anxiety Inventory Scales , Fibromyalgia Impact Question naire and Short Form 36 were used as outcome measures which were applied at baseline and 2nd , 4th , 8th , 16th , 24th weeks . Mean amplitudes of EEG rhythms ( delta , theta , alpha , SMR , beta1 and beta2 ) and theta/SMR ratio were also measured in NFB group . All post-treatment measurements showed significant improvements in both of the groups ( for all parameters p NFB group displayed greater benefits than controls ( for all parameters p Therapeutic efficacy of NFB was found to begin at 2nd week and reached to a maximum effect at 4th week . On the other h and , the improvements in SSRI treatment were also detected to begin at 2nd week but reached to a maximum effect at 8th week . No statistically significant changes were noted regarding mean amplitudes of EEG rhythms ( p > 0.05 for all ) . However , theta/SMR ratio showed a significant decrease at 4th week compared to baseline in the NFB group ( p efficacy of NFB as a treatment for pain , psychological symptoms and impaired quality of life associated with fibromyalgia",
"OBJECTIVE In a r and omized controlled trial , we could demonstrate clinical efficacy of neurofeedback ( NF ) training for children with ADHD ( Gevensleben et al. , 2009a ) . The present investigation aim ed at learning more about the neuronal mechanisms of NF training . METHODS Children with ADHD either completed a NF training or a computerized attention skills training ( ratio 3:2 ) . NF training consisted of one block of theta/beta training and one block of slow cortical potential ( SCP ) training , each comprising 18 training units . At three times ( pre-training , between the two training blocks and at post-training ) , event-related potentials ( ERP ) were recorded during the Attention Network Test . ERP analysis focused on the P3 , reflecting inter alia attentional re sources for stimulus evaluation , and the contingent negative variation ( CNV ) , primarily related to cognitive preparation . RESULTS After NF training , an increase of the CNV in cue trials could be observed , which was specific for the SCP training . A larger pre-training CNV was associated with a larger reduction of ADHD symptomatology for SCP training . CONCLUSIONS CNV effects reflect neuronal circuits underlying re source allocation during cognitive preparation . These distinct ERP effects are closely related to a successful NF training in children with ADHD . In future studies , neurophysiological recordings could help to optimize and individualize NF training . SIGNIFICANCE The findings contribute to a better underst and ing of the mechanisms underlying NF training in children with ADHD",
"PURPOSE To evaluate the motor vehicle driving knowledge , skills , and negative driving outcomes of older teens and young adults with attention deficit hyperactivity disorder ( ADHD ) . LOCATION A university medical center clinic for adult ADHD . SUBJECTS A total of 25 young adults with ADHD and 23 young adults without ADHD 17 to 30 years old drawn from the community and equated for age , gender , and educational level . MEASURES Structured interview , behavior ratings by self- and others , video test of driving knowledge , computer simulated driving test , and official motor vehicle records . RESULTS ADHD young adults were cited more often for speeding , were more likely to have had their licenses suspended , were involved in more crashes , were more likely to have had crashes causing bodily injury , and were rated by themselves and others as using poorer driving habits . Official driving records corroborated these negative outcomes . Although no group differences in driving knowledge were evident , young adults with ADHD had more crashes , scrapes , and erratic steering during the computer-stimulated driving test than did the control subjects . CONCLUSIONS Findings supported previous research suggesting that greater driving risks are associated with ADHD and suggested that ADHD does not interfere with driving knowledge so much as with actual performance ( motor control ) during vehicle operation",
"Due to the high stability of its complexes with many M(2 + ) and M(3+)-ions , DOTA ( 1,4,7,10-tetraazacyclododecane-N , N',N″,N‴-tetraacetic acid ) is the most commonly used chelator for the derivatization and radiolabeling of bioactive molecules . Most of the currently used DOTA derivatives comprise amine-reactive functionalities , limiting their application to the derivatization of fully protected molecules or otherwise result ing in r and omly distributed conjugation sites of undefined number . Click chemistry reactions are a valuable alternative to this unspecific conjugation as they proceed efficiently and chemoselectively under mild conditions allowing a site-specific derivatization of unprotected biomolecules . In this work , we describe straightforward syntheses of DOTA derivatives containing thiol , maleimide , aminooxy , aldehyde , alkyne , and azide functionalities , amenable to the currently most often used click chemistry reactions . Furthermore , the efficiency of the respective click reactions introducing DOTA into bioactive molecules was investigated . For each of the synthesized DOTA synthons , the site-specific and efficient conjugation to Tyr(3)-octreotate could be shown . Among these , the addition and oxime formation reactions proceeded fast and without side reactions , giving the products in high yields of 64 - 83 % after purification . The copper-catalyzed triazole formation reactions produced some side-products , giving the desired products in lower , but still reasonable overall yields of 19 - 25 % . All synthesized peptide-DOTA-conjugates were labeled with (68)Ga in high radiochemical yields of 96 - 99 % and high specific activities providing compounds of high purity , demonstrating the applicability of all synthons for biomolecule modification and subsequent radiolabeling",
"In a r and omized controlled trial , neurofeedback ( NF ) training was found to be superior to a computerised attention skills training concerning the reduction of ADHD symptomatology ( Gevensleben et al. , 2009 ) . The aims of this investigation were to assess the impact of different NF protocol s ( theta/beta training and training of slow cortical potentials , SCPs ) on the resting EEG and the association between distinct EEG measures and behavioral improvements . In 72 ( of initially 102 ) children with ADHD , aged 8 - 12 , EEG changes after either a NF training ( n=46 ) or the control training ( n=26 ) could be studied . The combined NF training consisted of one block of theta/beta training and one block of SCP training , each block comprising 18 units of 50 minutes ( balanced order ) . Spontaneous EEG was recorded in a two-minute resting condition before the start of the training , between the two training blocks and after the end of the training . Activity in the different EEG frequency b and s was analyzed . In contrast to the control condition , the combined NF training was accompanied by a reduction of theta activity . Protocol -specific EEG changes ( theta/beta training : decrease of posterior-midline theta activity ; SCP training : increase of central -midline alpha activity ) were associated with improvements in the German ADHD rating scale . Related EEG-based predictors were obtained . Thus , differential EEG patterns for theta/beta and SCP training provide further evidence that distinct neuronal mechanisms may contribute to similar behavioral improvements in children with ADHD",
"Objective . This study examined the efficacy of 2 computer-based training systems to teach children with attention deficit/hyperactivity disorder ( ADHD ) to attend more effectively . Design / methods . A total of 41 children with ADHD from 2 middle schools were r and omly assigned to receive 2 sessions a week at school of either neurofeedback ( NF ) or attention training through a st and ard computer format ( SCF ) , either immediately or after a 6-month wait ( waitlist control group ) . Parents , children , and teachers completed question naires pre- and postintervention . Results . Primary parents in the NF condition reported significant ( P Conners ’s Rating Scales — Revised ( CRS-R ) and Behavior Assessment Scales for Children ( BASC ) subscales ; and in the SCF condition , they reported significant ( P the CRS-R Inattention scale and ADHD index , the BASC Attention Problems Scale , and on the Behavioral Rating Inventory of Executive Functioning ( BRIEF ) . Conclusion . This r and omized control trial provides preliminary evidence of the effectiveness of computer-based interventions for ADHD and supports the feasibility of offering them in a school setting",
"OBJECTIVE The paucity of data concerning the long-term natural history of attention-deficit hyperactivity disorder ( ADHD ) , a common childhood psychiatric disorder , prompted a longitudinal study to investigate the adult sequelae of the childhood disorder . DESIGN Prospect i ve study , follow-up intervals ranging from 13 to 19 years ( mean , 16 years ) , with blind systematic clinical assessment s. SUBJECTS Ninety-one white males ( mean age , 26 years ) , representing 88 % of a cohort systematic ally diagnosed as hyperactive in childhood , and 95 ( 95 % ) of comparison cases of similar race , gender , age , whose teachers had voiced no complaints about their school behavior in childhood . RESULTS Prob and s had significantly higher rates than comparisons of ADHD symptoms ( 11 % vs 1 % ) , antisocial personality disorders ( 18 % vs 2 % ) , and drug abuse disorders ( 16 % vs 4 % ) . Significant comorbidity occurred between antisocial and drug disorders . Educational and occupational achievements were significantly compromised in the prob and s. These disadvantages were independent of psychiatric status . We did not find increased rates of affective or anxiety disorders in the prob and s. CONCLUSIONS Childhood ADHD predicts specific adult psychiatric disorders , namely antisocial and drug abuse disorders . In the adolescent outcome of this cohort , we found that these disturbances were dependent on the continuation of ADHD symptoms . In contrast , in adulthood , antisocial and drug disorders appeared , in part , independent of sustained ADHD . In addition , regardless of psychiatric status , ADHD placed children at relative risk for educational and vocational disadvantage . The results do not support a relationship between childhood ADHD and adult mood or anxiety disorders"
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BACKGROUND Antihypertensive drugs from the thiazide diuretic drug class have been shown to reduce mortality and cardiovascular morbidity . Loop diuretics are indicated and used to treat hypertension , but a systematic review of their blood pressure-lowering efficacy or effectiveness in terms of reducing cardiovascular mortality or morbidity from r and omized controlled trial ( RCT ) evidence has not been conducted . OBJECTIVES To determine the dose-related decrease in systolic or diastolic blood pressure , or both , as well as adverse events leading to participant withdrawal and adverse biochemical effects ( serum potassium , uric acid , creatinine , glucose and lipids profile ) due to loop diuretics versus placebo control in the treatment of people with primary hypertension . SEARCH METHODS We search ed the Cochrane Hypertension Group Specialised Register , the Cochrane Central Register of Controlled Trials ( CENTRAL , 2014 , Issue 9 ) , MEDLINE , MEDLINE In-Process , EMBASE , and Clinical Trials.gov to 27 October 2014 . SELECTION CRITERIA We included double-blind r and omized placebo-controlled trials of at least three weeks duration comparing loop diuretic with a placebo in people with primary hypertension defined as blood pressure greater than 140/90 mmHg at baseline . DATA COLLECTION AND ANALYSIS Two review authors independently assessed the risk of bias and extracted data . We used weighted mean difference and a fixed effects model to combine continuous outcome data . We analysed the drop outs due to adverse effects using relative risk ratio . MAIN RESULTS Nine trials evaluated the dose-related blood pressure-lowering efficacy of five drugs within the loop diuretics class ( furosemide 40 mg to 60 mg , cicletanine 100 mg to 150 mg , piretanide 3 mg to 6 mg , indacrinone enantiomer -2.5 mg to -10.0/+80 mg , and etozolin 200 mg ) in 460 people with baseline blood pressure of 162/103 mmHg for a mean duration of 8.8 weeks . The best estimate of systolic/diastolic blood pressure-lowering efficacy of loop diuretics was -7.9 ( -10.4 to -5.4 ) mmHg/ -4.4 ( -5.9 to -2.8 ) mmHg . Withdrawals due to adverse effects and serum biochemical changes did not show a significant difference . We performed additional search es in 2012 and 2014 , which found no additional trials meeting the minimum inclusion criteria . AUTHORS ' CONCLUSIONS Based on the limited number of published RCTs , the systolic/diastolic blood pressure-lowering effect of loop diuretics is -8/-4 mmHg , which is likely an overestimate . We grade d the quality of evidence for both systolic and diastolic blood pressure estimates as " low " due to the high risk of bias of included studies and the high likelihood of publication bias . We found no clinical ly meaningful blood pressure-lowering differences between different drugs within the loop diuretic class . The dose-ranging effects of loop diuretics could not be evaluated . The review did not provide a good estimate of the incidence of harms associated with loop diuretics because of the short duration of the trials and the lack of reporting of adverse effects in many of the trials
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"Summary : Twelve white men with essential hypertension were treated for 1 month in r and omized order with either placebo or low-dose furosemide ( 40 mg/day ) and compared to 22 race , age- , and diet-matched normal controls . Furosemide therapy significantly reduced mean arterial pressure ( 108.6 ± 2.4 vs. 101.0 ± 2.7 mm Hg . p increase in 24 hr urinary kallikrein activity ( 7.9 ± 1.8 vs. 13.4 ± 2.8 esterase units/24 hr . p Normal controls on no therapy excreted 19.4 ± 2.6 esterase units/24hr of urinary kallikrein activity , significantly greater than hypertensives on placebo ( p on furosemide ( p decrease in mean arterial pressure and the increase in urinary kallikrein activity induced by furosemide were not associated with a demonstrable change in renal hemodynamics . plasma renin activity , or plasma aldosterone concentration , but they were associated with a significant increase in intravascular volume ( 5.876 ± 339 vs. 6.808 ± 346 ml . p inverse correlation between mean arterial pressure and urinary kallikrein activity suggests a possible role for the kallikrein-kinin system in the antihypertensive mechanism of furosemide ",
"In a double‐blind study , 28 patients having mild to moderate essential hypertension were r and omly assigned to a 6‐week regimen of ticrynafen , hydrochlorothiazide , or placebo . Blood pressure fell after ticrynafen and hydrochlorothiazide . Serum uric acid fell strikingly with ticrynafen whereas it rose with hydrochlorothiazide . Serum potassium declined very little with ticrynafen ; much less than with hydrochlorothiazide . Serum creatinine and blood urea nitrogen rose slightly more with ticrynafen than with hydrochlorothiazide . There were no clinical adverse effects to either of the medications . Ticrynafen appears to be an effective antihypertensive with a substantial hypouricemic effect",
"Loop diuretics , such as torasemide and furosemide , are important agents in the treatment of chronic heart failure . Beneficial effects of torasemide immediate-release formulation beyond diuresis have been documented as the ability of this compound to inhibit myocardial synthesis and deposition of collagen type I in patients with chronic heart failure . In addition , torasemide-treated patients , but not furosemide-treated patients , showed decreased serum concentrations of the C-terminal propeptide of procollagen type I , a biochemical marker of myocardial fibrosis . The aim of the TORAFIC study is to test the efficacy of torasemide prolonged-release formulation ( PR ) in reducing myocardial fibrosis in chronic heart failure in a large , r and omized clinical trial . Methods : This prospect i ve , Phase IV , r and omized , blinded end point , active-controlled clinical trial will r and omize 142 patients with chronic heart failure in New York Heart Association functional class II – IV to 8 months treatment with either torasemide-PR ( 10–40 mg daily ) or furosemide ( 40–160 mg daily ) . The primary objective is to test the hypothesis that torasemide-PR is superior to furosemide in reducing myocardial fibrosis . The primary outcome measure is the difference in the change of serum propeptide of procollagen type I concentration from the initial to the final visit between both study groups . Secondary outcome measures include all efficacy variables related to heart failure ( signs and symptoms , ECG , echocardiogram and serum levels of N-terminal brain natriuretic propeptide ) . Secondary safety variables are heart rate , blood pressure , laboratory data , adverse events , cardiovascular events ( hospital admission , emergency department visits ) and quality of life ( Minnesota question naire ) . Discussion : This trial will test whether torasemide-PR possesses antifibrotic properties , which may provide an additional benefit beyond diuresis in patients with chronic heart failure",
"The antihypertensive efficacy and tolerability of a fixed-dose combination containing 40 mg penbutolol ( a beta-blocking agent ) and 6 mg piretanide ( a diuretic ) in comparison to placebo was investigated in a double-blind , crossover study in 20 patients with mild to moderate essential hypertension . After a 1-week period on placebo , patients were allocated at r and om to receive 1 tablet daily for 4 weeks of either the combination preparation or placebo and were then crossed over to the alternative medication for a further 4 weeks . The reduction in systolic and diastolic blood pressure both at rest , during maximal ergometric exercise and isometric word load , and also in the diurnal blood pressure profile over 24 hours was significantly greater in the group treated with the fixed-dose combination than in the placebo group . Pulse rate was also decreased to a greater extent . Mean diastolic blood pressure before exercise was reduced to normal ( 85.5 mmHg ) after 4-weeks ' treatment with the fixed-dose combination . Biochemical , haematological and urinary parameters showed no clinical ly relevant changes after either treatment . One patient complained of transient dizziness during treatment with the fixed-dose combination . No patient withdrew prematurely from the study because of side-effects",
" Eighteen patients whose clinic blood pressure ( BP ) remained over 95 mmHg despite treatment with captopril 50 mg twice daily plus frusemide 40 mg twice daily were r and omised in a crossover study to four weeks ' treatment with once daily atenolol 100 mg , slow release propranolol 160 mg or placebo . The reduction in BP on atenolol was superior to that on both propranolol and placebo . The mean supine BP 24 hours post dosing were 177/110 mmHg ( placebo ) , 173/109 mmHg ( propranolol ) and 164/100 mmHg ( atenolol ) . The corresponding mean heart rates were 77 bpm ( placebo ) , 63 bpm ( propranolol ) and 62 bpm ( propranolol ) and 62 bpm ( atenolol ) . The difference in hypotensive efficacy between atenolol and propranolol is not readily explained but our study shows that atenolol has a clinical ly useful supplementary effect on BP . Refractory hypertension remains an important clinical problem and further studies are required to establish the optimum combination of drugs that should be used with captopril in order to achieve ' target ' BP in patients with moderate to severe hypertension",
"BACKGROUND Contrast nephropathy ( CN ) is a common cause of renal dysfunction that may be prevented by saline hydration and by drugs such as theophylline or furosemide . Whether oral saline hydration is as efficient as intravenous saline hydration is unknown . The preventive efficacy of theophylline and furosemide for CN remains controversial . The purpose of the current study was to evaluate the efficacy of oral saline hydration and of intravenous saline hydration plus theophylline or furosemide for the prevention of CN . METHODS We prospect ively studied 312 patients with chronic renal failure ( serum creatinine 201+/-81 micromol/l , Cockcroft clearance 37+/-12 ml/min/1.73 m(2 ) ) , who were undergoing various radiological procedures with a non-ionic , low osmolality contrast agent . Patients were r and omly assigned to four arms . In arm A , patients received 1 g/10 kg of body weight/day of sodium chloride per os for 2 days before the procedure . In arm B , patients received 0.9 % saline intravenously at a rate of 15 ml/kg for 6 h before the procedure . In arm C , patients received the same saline hydration as in arm B plus 5 mg/kg theophylline per os in one dose 1 h before the procedure . In arm D , patients received the same saline hydration as in arm B plus 3 mg/kg of furosemide intravenously just after the procedure . RESULTS Patients were well-matched with no significant differences at baseline in any measured parameters . Acute renal failure , defined as an increase in serum creatinine of 44 micromol/l ( 0.5 mg/dl ) , occurred in 27 out of 312 patients ( 8.7 % ) . There was no significant difference between the rate of renal failure in the different arms of the study : five out of 76 ( 6.6 % ) in arm A , four out of 77 ( 5.2 % ) in arm B , six out of 80 ( 7.5 % ) in arm C and 12 out of 79 ( 15.2 % ) in arm D. No patient had fluid overload or a significant increase in blood pressure in the 2 days following the radiological procedure . The independent predictors of CN were diabetes mellitus , high baseline serum creatinine and high systolic blood pressure . CONCLUSIONS Oral saline hydration was as efficient as intravenous saline hydration for the prevention of CN in patients with stage 3 renal diseases . Furosemide and theophylline were not protective",
"Diuretics are frequently required to treat fluid retention in patients with congestive heart failure ( CHF ) . Unfortunately , they can lead to a decline in renal function , electrolyte depletion , and neurohumoral activation . Arginine vasopressin ( AVP ) promotes renal water reabsorption via the V2 receptor , and its levels are increased in CHF . This study was design ed to assess the effects of a single oral dose of tolvaptan , a selective V2-receptor blocker , in the absence of other medications , on renal function in human CHF and to compare this to the effects of a single oral dose of furosemide . We hypothesized that V2-receptor antagonism would yield a diuresis comparable to furosemide but would not adversely affect renal hemodynamics , plasma electrolyte concentration , or neurohumoral activation in stable human CHF . Renal and neurohumoral effects of tolvaptan and furosemide were assessed in an open-label , r and omized , placebo-controlled crossover study in 14 patients with NYHA II-III CHF . Patients received placebo or 30 mg of tolvaptan on day 1 and were crossed over to the other medication on day 3 . On day 5 , all subjects received 80 mg of furosemide . Tolvaptan and furosemide induced similar diuretic responses . Unlike tolvaptan , furosemide increased urinary sodium and potassium excretion and decreased renal blood flow . Tolvaptan , furosemide , and placebo did not differ with respect to mean arterial pressure , glomerular filtration rate , or serum sodium and potassium . We conclude that tolvaptan is an effective aquaretic with no adverse effects on renal hemodynamics or serum electrolytes in patients with mild to moderate heart failure",
"The antihypertensive effect and tolerability of enalaprilat , an intravenously administered angiotensin converting enzyme inhibitor , was studied in 65 patients with moderate or severe hypertension . In this r and omized , double-blind study , enalaprilat was compared with placebo in 42 ( 22 enalaprilat , 20 placebo ) moderate hypertensive ( diastolic blood pressure [ BP ] 100 to 114 mm Hg ) patients . It was compared with furosemide in 23 ( 12 enalaprilat , 11 furosemide ) severe hypertensive ( diastolic BP 115 to 130 mm Hg ) patients . Enalaprilat ( 1.25 or 5.0 mg ) , placebo ( 5 % dextrose ) or furosemide ( 40 or 80 mg ) was given every 6 hours intravenously up to 48 hours . In the moderate hypertension stratum , the mean supine diastolic BP was significantly ( p less than or equal to 0.01 ) reduced from baseline at all timepoints in the enalaprilat group . These diastolic BP reductions were significantly ( p less than or equal to 0.01 ) greater in the enalaprilat group than the placebo at 1 to 24 hours ( -12 vs -4 mm Hg ) , with 59 % of the patients responding to enalaprilat compared with 30 % of the patients responding to placebo . An even greater reduction ( p less than or equal to 0.01 ) was seen at 25 to 48 hours ( -14 vs -7 mm Hg , with 73 % enalaprilat vs 58 % placebo responders ) . Significant ( p less than or equal to 0.01 ) reductions in mean , supine systolic BP were also seen at 1 to 24 hours ( -22 vs -2 mm Hg ) and 25 to 48 hours ( -24 vs -8 mm Hg ) during the 48 hours of the double-blind treatment phase in the enalaprilat group compared with placebo . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND In chronic kidney disease ( CKD ) , loop diuretics correct volume-dependent hypertension , but their effect on left ventricular mass index ( LVMI ) is unknown . METHODS Forty hypertensive CKD patients ( estimated creatinine clearance 60 - 15 mL/min/1.73 m² ) , treated with renin-angiotensin system ( RAS ) inhibitors , were r and omized to receive furosemide or non-diuretic antihypertensive treatment ( control group ) . Office blood pressure ( BP ) the reduction of LVMI after 52 weeks . Secondary aims were to verify safety related to furosemide treatment and its effects on ambulatory and clinic BP and body fluid volumes . RESULTS Office BP similarly declined in the furosemide group ( from 161 ± 14/80 ± 10 to 139 ± 14/74 ± 8 mmHg ) and in controls ( from 159 ± 16/81 ± 10 to 137 ± 16/75 ± 10 mmHg ) . We detected a greater reduction ( P = 0.013 ) of LVMI in patients receiving furosemide ( -7.9 , IQR from -15.8 to -1.4 g/h(2.7 ) ) than in controls ( 0.0 , IQR from -6.2 to + 9.5 g/h(2.7 ) , P = 0.013 ) . Bio-impedance analysis -derived extracellular water ( ECW ) significantly decreased in furosemide-treated patients ( from 18.7 ± 3.9 to 17.7 ± 3.3 L ) while remained unchanged in the control group ( from 19.5 ± 2.2 to 19.6 ± 1.9 L ) . Absolute change of LVMI correlated with changes of ECW in furosemide-treated patients ( r = 0.458 , P = 0.042 ) but not in controls . In the furosemide group , no patient experienced side effects requiring drug withdrawal . CONCLUSIONS In hypertensive CKD patients treated with RAS inhibitors , add-on furosemide efficaciously reduces LVMI independently from BP changes . The effect is possibly mediated by better control of volume expansion",
"In a r and omized , double-blind parallel group study the 24-hour hypotensive effect of piretanide and its influence on biochemical variables were compared with those of placebo in patients with mild to moderate essential hypertension . Sixty patients entered the study , all of whom met the inclusion criteria ( RRdiast between 95 and 120 mmHg ) . There was no drop-out during the study , so that the results of all 60 patients were statistically analysed . Piretanide produced a significant reduction of both systolic and diastolic blood pressure over 24 hours which was evident at four weeks and was maintained and further enhanced over the ensuing trial period . A mean maximal fall ( at 12 weeks ) of 10.7 % ( BPdiast supine ) was observed . Placebo tablets did not produce any clinical ly relevant changes in systolic blood pressure , whereas a slight decrease was seen in diastolic blood pressure . This blood pressure reduction was significantly less in the placebo group than in the piretanide group at the end of the study ( weeks 10 and 12 ) . Dose doubling was needed in 13 of the 30 patients in the piretanide group , whereas as many as 20 out of 30 patients needed dose doubling in the placebo group . Pulse rate did not change relevantly during the trial in either group . A slight reduction in body weight was observed in the piretanide group . The mean values of serum potassium and sodium showed a slight decrease but remained within the normal range during the study period . A small increase in serum phosphorus was noted . None of these changes required any specific measures . ( ABSTRACT TRUNCATED AT 250 WORDS",
"UNLABELLED The present study attempts to assess the efficacy combination therapy for heart failure . Genuine dose-response studies on combination therapy are not available and published studies involved adding one drug on top of ' usual treatment ' . Sixteen different dosage combinations of tr and olapril and bumetanide was tested in a double blind , double placebo-controlled , r and omized , multiple cross-over study in a 16 times six balanced incomplete Latin square design . Patients reported optimal quality of life on the sub maximal dose bumetanide . Bumetanide decreased left ventricular function and increased heart rate and plasma noradrenaline in a dose dependent manner . Doses of bumetanide of more than 0.5 mg , given twice daily significantly decreased the quality of life and increased diuresis . Weight loss was maximal on 0.5 mg bumetanide twice daily . Tr and olapril significantly reduced systolic blood pressure with the maximal effect at 0.5 mg daily . Both drugs significantly increased renin concentration with a significant potentiating interaction . It was not possible to detect beneficial effects of combination therapies . The optimal dosage of Bumetanide appeared to be 0.5 mg twice daily based on its effect on quality of life and weight loss . Estimated by the reduction in systolic blood pressure the optimal dosage of Tr and olapril appeared to be 0.5 mg once daily . CONCLUSIONS It appears that patients should be given less than the usually recommended dosages . Patients may be treated with a low dose loop diuretic , if signs of water retention are present or if symptomatic relief is desired",
"UNLABELLED This study compares the loop diuretic piretanide 6 mg in a slow-release formulation ( PIR ) with hydrochlorothiazide 25 mg ( HCT ) and the fixed combination altizide 15 mg-spironolactone 25 mg ( ALT-SP ) in hypertension . 1105 mild to moderate hypertensive patients entered a three-week placebo wash-out period ; 899 were r and omized in a 6-month , double-blind , parallel group treatment phase ; 800 completed the study . Primary end-points ; serum potassium concentration and quality of life at one month ; secondary end-points : ionic , renal and metabolic variables ; blood pressure ( BP ) measurements . HCT and ALT-SP were compared only to PIR using Dunnett 's or chi 2 tests . RESULTS No difference was found for the overall quality of life . No change of serum potassium concentration at one month was found in PIR while small decreases were detected with ALT-SP ( -0.1 mM ) and HCT ( -0.26 mM ) . Serum creatinine concentration increased significantly in ALT-SP when compared to PIR . All the drugs were effective in reducing BP : HCT had a higher rate of responders than PIR with similar mean BP falls and ALT-SP induced greater falls in blood pressure . CONCLUSION PIR proves to be a potent antihypertensive drug without significant effect on serum electrolytes , plasma glucose and lipids . HCT was slightly more potent but induced a fall in serum potassium concentration with a significant risk of hypokalaemia . The addition of SP to ALT led to a more potent diuretic with a higher level of serum potassium and plasma creatinine disturbances",
"OBJECTIVE To evaluate the efficacy of the monotherapy of 15 agents in treating essential hypertension . METHODS After 2-week wash-out , a total of 370 patients with seated diastolic blood pressure 95 - 114 mmHg and seated systolic blood pressure were r and omized to different therapeutic groups . 24-hour ambulatory blood pressure monitoring was performed before medication and at the end of 8 weeks . RESULT All the agents significantly reduced the 24 hour mean blood pressures after treatment except doxazosin , terazosin , and torasemide . CONCLUSION The result suggested that the angiotensin-converting enzyme inhibitors , angiotensin II receptor blockers , beta-blockers and long-acting calcium antagonists were effective in treating essential hypertension , while the low-dose doxazosin , terazosin and torasemide can be used for combination therapy but not for monotherapy",
"BACKGROUND Increased vasopressin levels may be present in patient with chronic heart failure ( HF ) and contribute to pathophysiology through effects on the vasopressin V2 receptor . The presence of background diuretic therapy may confound evaluations of vasopressin receptor antagonists ( VRA ) . METHODS AND RESULTS Eligible patients had HF ( New York Heart Association Class II-III ) , systolic dysfunction ( left ventricular ejection fraction ≤0.40 ) and signs of congestion ( eg , edema , rales ) . At screening , patients were removed from baseline diuretic therapy and placed on a low-sodium diet ( 2 g/day ) . After a 2-day run-in period , 83 patients were r and omized to placebo ( n = 21 ) , monotherapy with the vasopressin V2 receptor antagonist tolvaptan ( TLV ) 30 mg ( n = 20 ) , monotherapy with furosemide 80 mg ( FURO , n = 22 ) or both TLV 30 mg and FURO 80 mg ( n = 20 ) once daily for 7 days . Patients were on st and ard background therapy and not fluid-restricted throughout the study . A decrease in body weight of -1.37 ± 1.61 , -0.54 ± 1.59 , and -1.13 ± 1.49 kg was observed versus baseline for TLV , FURO , and TLV+FURO , respectively , at day 8 . At the same point , the placebo group showed a body weight increase of + 0.72 ± 2.42 kg versus baseline ( P = .0006 for TLV versus placebo ) . Increases in urine volume from baseline were greater with TLV alone ( 2646 ± 1503 mL/24 hours ) than with FURO ( 894 ± 853 mL/24 hours , P hours ) . An increase in serum sodium within the normal range was also observed in TLV-treated patients ( P No changes in serum potassium , other laboratory values , or blood pressure were observed . TLV therapy was well tolerated . CONCLUSIONS In patients with HF and signs of volume overload , TLV monotherapy without concomitant loop diuretic therapy reduced body weight when compared to placebo without adverse changes in serum electrolytes , during a sodium restricted diet while on background medications including angiotensin-converting enzyme inhibitors and β-blockers",
"BACKGROUND In heart failure patients , diuretics cause renin-angiotensin-aldosterone system ( RAS ) activation , which may lead to increased morbidity and mortality despite short-term symptomatic improvement . AIM To determine changes in RAS activation and clinical correlates following furosemide withdrawal in elderly heart failure patients without left ventricular systolic dysfunction . METHODS AND RESULTS We performed clinical assessment s and laboratory determinations of aldosterone , plasma renin activity ( PRA ) , atrial natriuretic peptide ( ANP ) , norepinephrine , and endothelin in 29 heart failure patients [ aged 75.1+/-0.7 ( mean+/-S.E.M. ) years ] , before , 1 and 3 months after placebo-controlled furosemide withdrawal . Recurrent congestion occurred in 2 of 19 patients withdrawn , and in 1 of 10 patients continuing on furosemide . Three months after withdrawal , PRA had decreased -1.61+/-0.71 nmol/l/h ( P aldosterone levels did not reach significance ( -0.17+/-0.38 nmol/l ) . The decreases in PRA after withdrawal correlated with decreases in systolic ( r(s)=0.61 , P=0.020 ) and diastolic blood pressure ( r(s)=0.80 , P=0.01 ) . Successful withdrawal was associated with increases in norepinephrine ( + 0.58+/-0.22 nmol/l ) and ANP ( + 3.5+/-1.3 pmol/l ) ( P Endothelin levels did not change in both groups . CONCLUSION Successful furosemide withdrawal in elderly heart failure patients causes persistent decreases in RAS activation",
"Seventeen patients with mild to moderate essential hypertension and controlled with antihypertensive drugs were treated with xipamid ( 40 mg ) or hydrochlorothiazide ( 50 mg ) in a double-blind cross-over r and omized trial design . After a run-in-period of 2 weeks with placebo , all of them received either of the two drugs . Placebo treatment for 2 weeks decreased both supine as well as st and ing blood pressure , but it was not statistically significant . Xipamid produced a somewhat greater decrease in blood pressure than hydrochlorothiazide , but the difference was not statistically significant . Similar results were obtained in 12 newly diagnosed cases of mild to moderate essential hypertension treated with xipamid ( 80 mg ) or hydrochlorothiazide ( 100 mg ) daily as single drug treatment in a r and omized , double-blind parallel design trial . The side effects produced by both drugs were only mild in nature . No significant changes were produced in serum electrolytes , uric acid and fasting blood glucose in this short term study with either of the drugs",
"In a r and omized double-blind trial we compared the effects of torasemide , a new loop diuretic , and furosemide in nonazotemic cirrhotic patients with ascites during a 3-day period in association with potassium canrenoate ( 200 mg/day ) administration . Doses of loop diuretics administered in this trial ( 10 and 25 mg/day of torasemide and furosemide , respectively ) had been shown to be equipotent in healthy subjects . Torasemide induced significantly greater natriuresis than furosemide ( p less than 0.02 ) , with a twofold greater percentage increase in basal values ( day 1 : 130 % vs. 50 % ; day 2 : 104 % vs. 42 % ; and day 3 : 65 % vs. 26 % , respectively ) . Body weight loss was significantly higher during torasemide ( p less than 0.02 ) administration , and the overall decrease at the end of the treatment was twice as high for furosemide ( 2.5 + /- 0.6 kg vs. 1.3 + /- 0.4 kg , respectively ) . Diuresis was also higher during torasemide administration , but the difference was not significant ( p = 0.08 ) . The extent of kaliuresis observed during the two treatments was almost identical despite the striking differences in the natriuretic response . The effects of the two treatments on plasma electrolytes , creatinine clearance , blood urea nitrogen , mean arterial pressure , heart rate and plasma arginine vasopressin concentration were similar . Both drugs caused increases in plasma renin activity at the end of the treatment , whereas plasma aldosterone concentration slightly increased only after torasemide administration . Despite the presence of a trend toward a more pronounced effect on these parameters after torasemide administration , no significant difference between the two treatments was observed . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Sixteen patients with moderate essential hypertension completed a double-blind crossover trial with four treatment periods each of 6 weeks . They received in r and om order : placebo ; tienilic acid 250 mg/day ; propranolol 80 mg twice daily ; and tienilic acid 250 mg/day combined with propranolol 80 mg twice daily . Average blood-pressure in the lying position was 22.6/13.1 kPa ( 169/98 mm Hg ) on placebo ; 21.0/12.5 ( 157/94 ) on tienilic aicd ; 21.2/12.0 ( 159/90 ) on propranolol , and 18.9/11.5 ( 142/86 ) on tienilic acid combined with propranolol . The effects of tienilic acid and propranolol on blood-pressure were additive and there were no statistically significant interactions . Tienilic acid significantly reduced serum-urate from 0.33 to 0.18 mmol/l and induced hypokalaemia which was corrected by propranolol . Basophil count and haemoglobin were lower after tienilic acid treatment than they had been at the start of the study",
"Sixteen patients with moderately severe essential hypertension completed a double-blind crossover trial with four treatment periods each lasting for six weeks . They received in r and om order , placebo ; tienilic acid 250 mg/day ; propranolol 80 mg b.d . ; and tienilic acid 250 mg/day and propranolol 80 mg b.d . in combination . Mean blood pressure in the lying position was 169/98 mmHg on placebo , 157/94 mmHg on tienilic acid , 159/90 mmHg on propranolol and 142/86 mmHg on the combination of tienilic acid and propranolol . The effects of tienilic acid and propranolol on blood pressure were additive and there was no evidence of any interaction . The onset of the hypotensive effect of tienilic acid was gradual while the effect of propranolol was maximal within 2 weeks of the start of treatment . Tienilic acid produced a significant reduction in serum urate from 0.33 mmol/l to 0.18 mmol/l . The combination of tienilic acid and propranolol in the doses used in the trial was effective and acceptable in the reduction of raised blood pressure",
"BACKGROUND Acute decreases in intravascular volume are associated with increases in lipid levels . Furosemide causes acute changes in intravascular volume during prolonged therapy but is thought to have little effect on lipid levels . METHODS To determine if there are daily acute rises in lipid and lipoprotein levels associated with changes in intravascular volume during long-term furosemide ingestion therapy , we performed a r and omized , double-blind , placebo-controlled crossover study in 10 patients . RESULTS In the 8 hours after furosemide ingestion there were increases in levels of plasma cholesterol ( 10.1 % ; P = .001 ) , high-density lipoprotein cholesterol ( 9.0 % ; P = .006 ) , and apolipoprotein B ( 9.8 % ; P = .003 ) . The increases in levels of triglycerides ( 11.5 % ; P = .17 ) and apolipoprotein A-1 ( 13.3 % ; P = .051 ) were of similar magnitude but more variable and did not achieve statistical significance . There was no substantial change in the total cholesterol-high-density lipoprotein cholesterol ratio ( 0.6 % ; 95 % CI,-0.74 % to 8.6 % ; P = .88 ) . CONCLUSION This study indicates that there are acute increases in lipid levels after furosemide ingestion during prolonged therapy , which could affect the interpretation of lipid levels and cardiovascular risk in patients",
"Previous studies in white and mixed-race hypertensive patient population s have generally found patients with low renin activity more responsive to diuretic therapy than patients with normal renin activity . Twenty-nine black patients ( 26 women and three men ) with placebo diastolic blood pressure of 90 to 115 mm Hg were treated with spironolactone ( 100 to 400 mg/day ) and hydrochlorothiazide ( 100/mg/day ) . Renin status was categorized by ( 1 ) the intravenous furosemide test , ( 2 ) ambulation during placebo , and ( 3 ) ambulation during spironolactone and hydrochlorothiazide treatment . Only seven patients were categorized identically with all methods . No method identified a low renin subgroup that was more responsive to either spironolactone or hydrochlorothiazide . Diastolic blood pressure fall with hydrochlorothiazide ( 18 mm Hg ) and 400 mg/day of spironolactone ( 15 mm Hg ) was similar . Thus , since black women with both low and normal renin activity are quite responsive to diuretics , renin classification to guide initial antihypertensive selection is not warranted",
"The enantiomers of indacrinone ( I ) , an investigational loop diuretic , have different pharmacologic activity . The ( - ) enantiomer is natriuretic , and the ( + ) enantiomer is uricosuric . To determine the antihypertensive effects and an isouricemic ratio of indacrinone enantiomers , 37 patients with sitting diastolic blood pressure ( BP ) between 90 and 104 mm Hg , after a 4-week placebo washout , r and omly received one of the ratios of I enantiomers , namely -2.5/+80 mg ( A ) , -5/+80 mg ( B ) , -10/+80 mg ( C ) or placebo ( P ) , once daily for 12 weeks in a double-blind , parallel study . The mean reductions ( baseline-end of treatment ) in BP of 23/8 , 20/10 and 25/10 mm Hg with treatments A , B and C respectively were greater ( p less than 0.01 ) than that on P ( 0/3 ) . Initially , serum uric acid decreased with treatments A and B but not with C. Mean changes in serum uric acid were -0.3 , -0.4 , 0.2 and 0.3 mg/dl respectively with treatments A , B , C and P. The ratio of -10/+80 mg produced least variation in serum uric acid . Reduction in serum K+ and Cl- appeared to be dose related to ( - ) enantiomer . No serious adverse effects were reported . A 1:9 ratio of I enantiomers intended for wide-scale use as a diuretic also showed good antihypertensive activity , a favorable uric acid profile and absence of hepatic toxicity in 14 patients",
"In a r and omized double-blind parallel group study conducted in three centres the hypotensive activity of piretanide 6 mg b.i.d . was compared with that of hydrochlorothiazide ( HCT ) 25 mg b.i.d . and HCT 50 mg b.i.d . Ninety-three patients entered the study and sixty-one completed a 16–week trial period . All three treatments produced a significant reduction in supine diastolic and systolic blood pressure after only 2 weeks of active treatment and this was maintained for the duration of the study . The mean maximal reduction in supine diastolic blood pressure was 18 % in the piretanide group , 18·8 % in the HCT 25 mg b.i.d . group , and 20 % in the HCT 50 mg b.i.d . group . The corresponding figures for the percentage of patients attaining a supine diastolic pressure below 95 mm Hg were 83 % , 62 % and 89 % . There were no significant differences between the three groups . Side-effects were generally mild and transient , except for polyuria which was noted in all three groups but more commonly in the piretanide group . Two patients were withdrawn because of side-effects : one patient in the high dose HCT group developed severe postural symptoms ; and one patient in the low dose HCT group was withdrawn because of restlessness , nausea , weakness , dizziness and somnolence . All three treatments caused a significant increase in serum uric acid concentrations . Four patients in each of the HCT groups developed hypokalemia , but no patients in the piretanide group did so",
"The antihypertensive action of furosemide was evaluated in double-blind studies conducted in three different hospital clinics , by investigators following an identical protocol . The pressure lowering effect of furosemide was compared with that of a placebo in a r and omized cross-over study . Both systolic and diastolic pressures were lowered significantly from pretreatment levels in over 50 % of patients . No clinical ly important side effects attributable to furosemide were encountered in this study . Hyperuricemia was encountered in 31 of 44 patients . No significant disturbances of electrolyte balance were noted . Statistical analysis of the pooled data supported the conclusion that furosemide exerts an antihypertensive effect similar to that of other widely used sulfonamide diuretics , and therefore appears to be an effective agent for the treatment of mild to moderate hypertension",
"Efficacy and tolerance of cicletanine , the first derivative of furopyridines have been studied in a 3 parallel groups double blind study ; 120 essential mild hypertensive patients uncontrolled by beta blocking therapy were included . After a period of one month during which a treatment by placebo was added to beta blocking therapy , the patients were r and omly allocated into 3 groups : group I ( placebo : 40 patients ) , group II ( cicletanine 50 mg/d : 41 patients ) , group III ( cicletanine 100 mg/d : 39 patients ) . Eight patients were withdrawn in the group I ( poor efficacy , n = 5 or unexpected event , n = 3 ) , and one in the group III ( unexpected event ) . At the beginning of the treatment period ( DO ) , lying blood pressure ( LBP ) was respectively for groups I , II and III 171 + /- 14/104 + /- 6 , 174 + /- 13/104 + /- 5 , 172 + /- 15/105 + /- 6 mmHg . 171 + /- 14/104 + /- 6 , 174 + /- 13/104 + /- 5 , 172 + /- 15/105 + /- 6 mmHg . After 3 months of treatment LBP was respectively 168 + /- 21/97 + /- 10 , 151 + /- 12/85 + /- 7 , 147 + /- 14/82 + /- 9 mmHg . A significant treatment effect ( p less than 0.001 ) was observed on SBP with groups II and III only , and on DBP with the 3 groups . This lowering effect was comparable in groups II and III , and greater ( p less than 0.001 ) in these groups than in group I. At the end of this study the percentage of patients whose BP was normalized was respectively for groups I , II and III : 5 p. 100 , 51 p. 100 and 74 p. 100 . Clinical and biological tolerance were good . ( ABSTRACT TRUNCATED AT 250 WORDS",
" Out of thirty-six patients with mild to moderate hypertension twenty-six patients completed a double-blind comparison of slow-release frusemide at two dose levels , and placebo . The two groups differed in their age pattern , baseline level of blood pressure and response to a low-salt diet during the wash-out/run-in period . Despite the lack of comparability of the two groups , firm clinical inferences could be drawn from the study . Seven of the eighteen placebo patients had to be withdrawn from further participation because of deterioration in their hypertension : in contrast , fifteen of the eighteen frusemide patients showed an anti-hypertensive response and none was withdrawn because of lack of effect . Twice-daily administration of the slow-release formulation , however , produced an unacceptable level of such side-effects as nocturia , nausea and vomiting . Once-daily administration of the preparation is therefore preferred",
"A double-blind crossover study was carried out in 20 patients with mild to moderate essential hypertension to assess the efficacy and tolerability of a low fixed-dose combination containing 20 mg penbutolol ( a beta-blocking agent ) and 3 mg piretanide ( a diuretic ) in comparison to placebo over a period of 4 weeks . Active drug treatment in the 20 patients studied was preceded by a 1-week period of placebo . The results showed that there was an effective significant reduction in systolic and diastolic blood pressure compared with initial levels in the fixed-dose combination group , when compared to the placebo group , both at rest , during maximal ergometric and isometric work load , and also in the diurnal blood pressure profile over 24 hours . Pulse rate also decreased in the combination group . The biochemical , haematological and urinary parameters showed no clinical ly relevant changes in either group during the entire study period . Minor side-effects definitely or probably associated with the treatment were observed in both groups but were generally mild and did not interfere with treatment . No patient withdrew prematurely from the trial",
" Nineteen patients with pre-eclampsia were r and omised to receive 40 mg of frusemide or placebo by mouth daily for 7 days in the first post-partum week . Outcome measures included mean and maximum blood pressure , the need for additional antihypertensive treatment during that period and mean length of hospital stay . There were no statistically significant differences in outcome between the treatment and placebo groups although there was a trend to more rapid lowering of blood pressure following delivery in those receiving frusemide",
"AIMS Diuretics , when used to treat congestion in patients with chronic heart failure , improve symptoms and , perhaps , prognosis but little information is available to guide their use in patients with left ventricular systolic dysfunction ( LVSD ) who are not congested . Chronic diuretic therapy causes persistent and potentially harmful neuroendocrine activation . Alternatively , in patients in whom neuroendocrine activation is blocked with angiotensin-converting enzyme (ACE)-inhibitors and beta-blockers , diuretics may be beneficial by decreasing preload and afterload and preventing congestion . We aim ed to assess the effect of the loop diuretic , torasemide on quality of life , and surrogate markers of prognosis when given to patients with LVSD who were not clinical ly congested and who were optimally treated with ACE-inhibitors ( or angiotensin receptor antagonists ) and beta-blockers . METHODS AND RESULTS Thirty patients with stable LVSD who had no clinical ly detectable fluid overload were r and omized to receive either torasemide 5 mg daily or placebo for 3 months ( Phase A ) , and after a washout phase of 2 months , cross-over was performed for 3 months ( Phase B ) . Diuretic therapy did not cause significant change in peak VO(2 ) , mean N-terminal pro-hormone brain natriuretic peptide ( NT-proBNP ) levels , or measures of quality of life compared with placebo . Diuretic therapy did however lead to significant fall in systolic and diastolic blood pressures and increase in plasma renin levels compared with placebo . CONCLUSION Diuretic therapy with torasemide is not superior to placebo in improving peak VO(2 ) or reducing NT-proBNP levels in patients with left ventricular dysfunction who are not clinical ly congested",
"The effectiveness of a new potent diuretic , xipamide , was evaluated in the treatment of patients with mild to moderate essential hypertension . The effects of daily doses of 40 mg xipamide were compared with those of 100 mg chlorthalidone with respect to systolic and diastolic blood pressure , using a double-blind crossover design . Patients received each drug for 6 weeks , the order of treatments being at r and om and the periods being separated by a ' washout ' period of 7 days . The results showed that xipamide was as effective as chlorthalidone in controlling blood pressure , both in the upright and supine positions , and when administered after chlorthalidone produced a further reduction . No such further reduction occurred when chlorthalidone was given after xipamide . Serum electrolyte changes induced by the two diuretics were comparable . Both drugs were well tolerated and caused few side-effects",
"To test the hypothesis that alternate-day administration of furosemide will result in a sustained improvement in pulmonary function without causing alterations in electrolyte or mineral homeostasis , we conducted a r and omized , double-blind , placebo-controlled study of 11 hospitalized , oxygen-dependent , spontaneously breathing infants with chronic bronchopulmonary dysplasia . Infants were r and omly selected to receive either furosemide , 4 mg/kg in two divided doses on alternate days orally , or placebo for 8 days , followed by crossover to the alternate-therapy for an additional 8-day period . The two study periods were separated by a 48-hour washout period . Dynamic compliance , total pulmonary resistance , the concentration of electrolytes in serum , and the concentrations of calcium and creatinine in urine were measured on nontreatment days . Alternate-day furosemide therapy increased dynamic lung compliance by 76 + /- 112 % and decreased total pulmonary resistance by 20 + /- 39 % , compared with placebo ( both variables p = 0.032 ) . Alternate-day furosemide therapy did not result in increased urine output , electrolyte abnormalities , or increased urinary calcium excretion . We conclude that this simplified treatment regimen may be useful in the management of infants with chronic bronchopulmonary dysplasia . The results support our previous speculation that furosemide improves pulmonary function by mechanisms unrelated to its diuretic properties",
"To test the dose responses of piretanide , ramipril , and their combination in patients with essential hypertension , a prospect i ve , r and omized , double-blind , placebo-controlled trial was conducted in 480 patients . Twelve separate groups were studied : placebo , piretanide 3 mg , piretanide 6 mg , ramipril 2.5 mg , ramipril 5 mg , ramipril 10 mg , and their combinations , as single daily morning doses . Patients were r and omized after a 2-week run-in period without drugs ; treatment was given for 6 weeks . A dose response compared with placebo was found for both drugs ; the combination was more effective than either drug alone . Piretanide 6 mg , combined with ramipril 5 mg , provided optimal blood pressure reduction . Self-reported adverse effects of both drugs and their combinations did not exceed those reported for placebo . A surface analysis suggested that piretanide primarily reduced systolic blood pressure , whereas ramipril was more effective in reducing diastolic blood pressure . The data attest to a combined efficacy of piretanide and ramipril in decreasing arterial blood pressure",
"A double-blind , r and omized , crossover trial was carried out in 26 hypertensive patients to investigate the hypotensive effects of three different dosages of frusemide ( 40 mg , 60 mg , and 80 mg twice daily ) and the effects on serum potassium and urinary output . The study included a 4-week treatment period with placebo , three periods of 6 weeks with frusemide , and an intervening placebo period of 4 weeks . The mean arterial blood pressure fell about 10 mmHg within the first 2 weeks and was independent of the frusemide dosage . During the following weeks of treatment , there was a constant , slow fall in blood pressure . The period on placebo was too brief for values to return to the initial level . In contrast , the increase in urinary output , which was dose-dependent , ceased when medication was withdrawn . The diuretic effect was maintained throughout the treatment periods . There was a correlation between the fall in serum potassium and the diuretic effect whereas no correlation with the fall in blood pressure could be shown . Except for a significant increase in serum zinc , no changes were observed in other electrolyte parameters . Body weight , pulse , haemoglobin and erythrocyte sedimentation rate remained unchanged . Side-effects were few and mild , but tended to increase with higher doses",
"1 . We have determined the ventilatory response to CO 2 at two levels of end-tidal O 2 tension in eight normal subjects before and after ( 1 ) 4 days of 0.242 mmol ( 80 mg ) oral frusemide daily and ( 2 ) 4 days of 0.024 mmol ( 10 mg ) bendrofluazide daily . 2 . Frusemide produced no significant alkalosis , change in end-tidal CO 2 tension or alteration in the CO 2 response line . However , we did demonstrate a linear relationship between the change in plasma total CO 2 content and the change in intercept of the CO 2 response line in hyperoxia after frusemide . 3 . Bendrofluazide produced a metabolic alkalosis with no significant change in end-tidal CO 2 tension . The CO 2 response line after the drug showed a decrease in slope in hyperoxia and a shift to the right of the intercept in hypoxia . There was no relationship between change in plasma total CO 2 content and change in the intercept of the CO 2 response line in hyperoxia . 4 . If these results obtained on normal subjects are applicable to patients with chronic bronchitis and emphysema , frusemide might be the diuretic of choice for use with controlled oxygen therapy in the management of acute exacerbations of this disease when it is complicated by ventilatory failure",
"In a double-blind study , thirty patients having mild to moderate essential hypertension were r and omly assigned to a six week regimen of either tienilic acid , hydrochlorothiazide , or placebo . Blood pressure was significantly reduced with tienilic acid and hydrochlorothiazide although more so with tienilic acid . Serum uric acid declined strikingly with tienilic acid and increased significantly with hydrochlorothiazide . Serum potassium declined slightly with tienilic acid but more so with hydrochlorothiazide . Serum creatinine and blood urea nitrogen increased slightly more with tienilic acid than with hydrochlorothiazide . There were no clinical adverse effects to any of the medications during this study . Twenty-four months of continuous administration of tienilic acid revealed maintenance of blood pressure effect , but with slight increases in blood urea nitrogen , serum creatinine and uric acid and slight decreases in serum potassium as compared to six weeks administration . Tienilic acid appears to be a useful new antihypertensive agent . The hypouricaemic effect is profound and strongly suggests the need for continuing evaluation of this compound because of its unique combination of diuretic , antihypertensive and hypouricaemic properties",
"本態性高血圧に対する利尿降圧剤 tripamide 1日15～60mg単独投与の有用性を60歳以上の老年者33例 ( 平均年齢65.9歳 ) と59歳以下の壮年者59例 ( 平均年齢50.0歳 ) に於て二重盲検法により検討した.降圧効果 ( 20/10mmHgまたは平均血圧13mmHg以上下降 ) は老年者で84.8 % , 壮年者で59.3%で , 老年者の降圧効果が有意に高いことを認めた ( p<0.05 ) . しかし降圧幅は老年者で32.0/13.2mmHg , 壮年者で26.9/11.2mmHgであり , 有意差を認めず , 老年者で過度の降圧を来さないことを示唆した.臨床検査のうち , 血液学検査では両年齢群とも有意の変動を認めず , 血液濃縮は見られなかった. 生化学検査では老年者では血清Cl , アルカリフォスファターゼの低下と尿素窒素 , 尿酸の上昇を , 壮年者では血清Clの低下と総コレステロール , Ca , 尿酸 , 尿素窒素の上昇を認めた. 血清Na , K , 空腹時血糖値には両年齢群とも変化を認めなかった. 心胸比は老年者で減少した. これらの変化は有意差を認めたものの正常範囲内の変化であり臨床的意義は少ないと思われる.副作用は壮年者で5例8%に認められたが , 老年者では認められなかった. 副作用に臨床検査値の異常変化例を含めると壮年者で9例15 % , 老年者で4例12%でいずれも有意差は見られなかった.従って有用性 ( 有用以上 ) は , 老年者で78.8 % , 壮年者で52.5%と有意差を認め ( p<0.05 ) , 利尿降圧剤 tripamide",
"Angiotensin is a potent coronary vasoconstrictor , but little is known of the effects of long-term activation of the renin-angiotensin system on coronary reserve in humans . The effects of exercise on coronary hemodynamics were determined in eight patients with mild essential uncomplicated hypertension , before and after treatment with furosemide ( 50 mg , to ensure activation of the renin-angiotensin system ) . Coronary sinus blood flow was measured by thermodilution technique , intra-arterial blood pressure was measured from the ascending aorta , and plasma renin activity was determined by radioimmunoassay . Oxygen supply and dem and were derived ( using coronary sinus blood flow multiplied by the arteriovenous oxygen difference to equal oxygen supply and heart rate multiplied by the mean systolic blood pressure to equal oxygen dem and ) both at rest and during isometric exercise ( h and grip to 50 percent of maximal effort for three minutes ) . The study was a single-blind crossover ( furosemide versus placebo ) design . Furosemide produced a significant reduction in coronary sinus blood flow , associated with an increase in coronary vascular resistance . Changes in mean arterial pressure and heart rate were insignificant . Slight reductions in plasma volume and mean right atrial pressure were observed . During isometric exercise , the increase in oxygen supply for a given increment in oxygen dem and was attenuated by furosemide . The contribution of the renin-angiotensin system to this effect was determined by the short-term administration of 25 mg of the angiotensin converting enzyme inhibitor captopril . Forty-five minutes after oral captopril , coronary reserve was restored to pretreatment values . In conclusion , furosemide modulates coronary reserve , and it is likely that this is because furosemide mediates activation of renin-angiotensin system , thus reducing the vasodilatory capacity of the coronary arteries"
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411827d2-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND The absolute risk of recurrences among patients using aspirin for prevention of cardiovascular events remains high . Persistent platelet reactivity despite aspirin therapy might explain this in part . Reported prevalences of this so-called aspirin resistance vary widely , between 0 % and 57 % . OBJECTIVES The aim of the study was to systematic ally review all available evidence on prevalence of aspirin resistance and to study determinants of reported prevalence . METHODS Using a predefined search strategy , we search ed electronic data bases MEDLINE , EMBASE , CENTRAL , and Web of Science . To be included in our analysis , articles had to contain a laboratory definition of aspirin resistance , use aspirin as secondary prevention , and report associated prevalence . RESULTS We included 34 full-text articles and 8 meeting abstract s. The mean prevalence of aspirin resistance was 24 % ( 95 % CI 20%-28 % ) . After adjustment for differences in definition , used dosage , and population , a statistically significant higher prevalence was found in studies with aspirin dosage or = 300 mg ( 36 % [ 95 % CI 28%-43 % ] vs 19 % [ 95 % CI 11%-26 % ] , P platelet aggregation using light aggregometry with arachidonic acid as an agonist had a pooled unadjusted prevalence of 6 % ( 95 % CI 0%-12 % ) . In studies using point-of-care platelet function-analyzing devices , the unadjusted prevalence was significantly higher , at 26 % ( 95 % CI 21%-31 % ) . CONCLUSIONS Prevalences widely differ between studies reporting on aspirin resistance . Both aspirin dosage and the method of defining aspirin resistance strongly influence estimated prevalence , which explains found heterogeneity among studies . On average , it appears that about 1 in 4 individuals may express biochemically defined aspirin resistance
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"BACKGROUND Late venous graft thrombosis , leading to recurrent ischemia , is frequently encountered in old , degenerated vein grafts with advanced atherosclerotic plaque formation . Aspirin has been indicated to maintain venous graft patency in the post-operative period . However , there is considerable evidence that aspirin resistance is of concern in patients with venous grafts . MATERIAL AND METHOD Prospect ively enrolled 14 patients ( 11 male , 3 female , Group 1 ) , who were shown to have at least one occluded saphenous vein graft on their late control coronary angiogram after bypass operation , were compared for the presence of aspirin resistance by PFA-100 with age- and sex-matched 14 patients ( 10 male , 4 female , Group 2 ) , who were found patent and well-functioning vein grafts without wall irregularities on late post-operative coronary angiograms ( mean 6.5+/-2.5 years ) , enrolled as a control group . RESULTS Mean CT of collagen/epinephrine cartridge in Group 1 was 197+/-85 s and significantly less than in Group 2 ( 279+/-44 s ; p=0.011 ) . It was found that 50 % of patients in Group 1 were so-called aspirin resistant , whereas in Group 2 , this ratio was 7.1 % ( p=0.033 ) . BMI ( p=0.038 , Beta=-0.322 ) , uric acid level ( p=0.023 , Beta=-0.355 ) , and CT by collagen/epinephrine cartridge ( p=0.008 , Beta=0.431 ) were independently predicting late occlusion of saphenous vein graft . CONCLUSION Aspirin resistance is highly prevalent in patients with occluded venous grafts at a relatively late period",
"OBJECTIVES This study was design ed to determine if aspirin resistance is associated with clinical events . BACKGROUND Aspirin resistance , defined by platelet function testing and presumed clinical unresponsiveness to aspirin , has been previously reported by our group and others . However , little information exists linking the laboratory documentation of aspirin resistance and long-term clinical events . METHODS We prospect ively enrolled 326 stable cardiovascular patients from 1997 to 1999 on aspirin ( 325 mg/day for > or = 7 days ) and no other antiplatelet agents . We tested for aspirin sensitivity by optical platelet aggregation using adenosine diphosphate ( ADP ) and arachidonic acid ( AA ) . The primary outcome was the composite of death , myocardial infa rct ion ( MI ) , or cerebrovascular accident ( CVA ) . Mean follow-up was 679 + /- 185 days . Aspirin resistance was defined as a mean aggregation of > or = 70 % with 10 microM ADP and > or = 20 % with 0.5 mg/ml AA . RESULTS Of the patients studied , 17 ( 5.2 % ) were aspirin resistant and 309 ( 94.8 % ) were not aspirin resistant . During follow-up , aspirin resistance was associated with an increased risk of death , MI , or CVA compared with patients who were aspirin sensitive ( 24 % vs. 10 % , hazard ratio [ HR ] 3.12 , 95 % confidence interval [ CI ] 1.10 to 8.90 , p = 0.03 ) . Stratified multivariate analyses identified platelet count , age , heart failure , and aspirin resistance to be independently associated with major adverse long-term outcomes ( HR for aspirin resistance 4.14 , 95 % CI 1.42 to 12.06 , p = 0.009 ) . CONCLUSIONS This study demonstrates the natural history of aspirin resistance in a stable population , documenting a greater than threefold increase in the risk of major adverse events associated with aspirin resistance",
"We report the incidence of aspirin nonresponsiveness in a prospect i ve , multicenter registry ( n=422 patients ) to be 23 % using the Ultegra Rapid Platelet Function Assay-ASA , and determined a history of coronary artery disease to be associated with twice the odds of being an aspirin nonresponder ( odds ratio 2.01 , 95 % confidence interval 1.189 to 3.411 , p=0.009 ) . Further prospect i ve studies are needed to correlate aspirin nonresponsiveness to adverse clinical events",
"Background and Purpose — Aspirin is used commonly to prevent ischemic strokes and other vascular events . Although aspirin is considered safe and effective , it has limited efficacy with a relative risk reduction of 20 % to 25 % for ischemic stroke . We sought to determine if aspirin as currently used is having its desired antiplatelet effects . Methods — We ascertained patients with cerebrovascular disease who were taking only aspirin as an antiplatelet agent . Platelet function was evaluated using a platelet function analyzer ( PFA-100 ) . PFA test results were correlated with aspirin dose , formulation , and basic demographic factors . Results — We ascertained 129 patients , of whom 32 % were taking an enteric-coated aspirin preparation and 32 % were taking low-dose ( ≤162 mg/d ) aspirin . For the entire cohort , 37 % of patients had normal PFA-100 results , indicating normal platelet function . For the patients taking low-dose aspirin , 56 % had normal PFAs compared with 28 % of those taking ≥325 mg/d of aspirin , while 65 % of patients taking enteric-coated aspirin had normal PFAs compared with 25 % taking an uncoated preparation ( P using mean closure times ( low-dose aspirin , 183 sec ; high-dose aspirin , 233 sec ; enteric-coated , 173 sec ; uncoated , 235 sec ; P Older patients and women were less likely to have a therapeutic response to aspirin , independent of aspirin dose or formulation . Conclusions — A significant proportion of patients taking low-dose aspirin or enteric-coated aspirin have normal platelet function as measured by the PFA-100 test . If these results correlate with clinical events , they have broad implication s in determining how aspirin is used and monitored",
"PURPOSE We sought to investigate the association of aspirin dose and aspirin resistance in stable coronary artery disease patients measured by a point-of-care assay . METHODS We studied 468 consecutive stable coronary artery disease patients in a referral cardiac center who were taking aspirin 80 to 325 mg daily for > or = 4 weeks . The VerifyNow Aspirin ( Ultegra RPFA-ASA , Accumetrics Inc , San Diego , Calif ) was used to determine aspirin responsiveness . An aspirin reaction unit ( ARU ) > or = 550 indicates the absence of aspirin-induced platelet dysfunction , based on correlation with epinephrine-induced light transmission aggregometry . Demographic and clinical data were collected to analyze the predictors of aspirin resistance . RESULTS Aspirin resistance was noted in 128 ( 27.4 % ) patients . Univariate predictors of aspirin resistance include elderly ( P = 0.002 ) , women ( P aspirin dose hemoglobin ( odds ratio [ OR ] 0.6 ; 95 % confidence interval [ CI ] 0.51 to 0.69 ; P aspirin dose Daily aspirin dose aspirin resistance compared with 150 mg and 300 mg daily ( 30.2 % vs 16.7 % vs 0 % , P = 0.0062 ) . CONCLUSION A 100 mg or less daily dose of aspirin , which may have lower side effects , is associated with a higher incidence of aspirin resistance in patients with coronary artery disease . Prospect i ve r and omized studies are warranted to eluci date the optimal aspirin dosage for preventing ischemic complications of atherothrombotic disease",
"BACKGROUND Acetylsalicylic acid , or aspirin , is widely used in secondary prevention of coronary artery diseases , but the inhibition of platelet aggregation is not uniform in all individuals . OBJECTIVE To investigate the prevalence of aspirin resistance at rest and during exercise in coronary artery disease patients . MATERIAL S AND METHODS Fifty patients with stable coronary artery disease were prospect ively studied . All patients received aspirin ( 75 - 300 mg/day for > 1 month ) and no other antiplatelet therapy . Aspirin resistance was studied , at rest and immediately after a stress test , using the st and ardized platelet function analyzer ( PFA-100(R ) , Dade-Behring ) . Aspirin resistance was defined as a normal collagen/epinephrine closure time ( aspirin-resistant at rest . Out of the 40 patients who were aspirin-sensitive at rest , 9 ( 22 % ) were aspirin-resistant immediately after the exercise stress test . There were no differences in aspirin sensitivity regarding gender , age , diabetes , hypertension , dyslipidemia , platelet count , medical treatment or number of the coronary arteries involved . CONCLUSIONS Aspirin resistance is detected , at rest , in 20 % of our patients with stable coronary artery disease . Aspirin treatment does not seem to protect against exercise-induced platelet activation in 22 % of such patients , despite aspirin sensitivity at rest",
"Background and Purpose — Recent studies suggest that patients who do not respond to aspirin ( ASA ) therapy may be at increased risk of ischemic vascular events . The availability of simple to use point-of-care ( POC ) platelet function tests now potentially allows aspirin nonresponsiveness to be identified in routine clinical practice . However , there are very few data on whether the different tests produce consistent results . We therefore compared 2 POC tests ( PFA-100 device and the Ultegra-RPFA [ RPFA ] ) with conventional light transmission aggregometry ( LTA ) . Methods — Platelet function was assessed by all 3 tests in 100 patients receiving low-dose ASA therapy after transient ischemic attack ( TIA ) or ischemic stroke . Results — The incidence of ASA nonresponsiveness was 17 % by the RPFA and 22 % by the PFA-100 , compared with only 5 % by LTA ( ie , as defined with both arachidonic acid and ADP ) . Agreement between the RPFA and the PFA-100 and arachidonic acid induced LTA was poor ( & kgr;=0.16 , 95 % CI , −0.08 to 0.39 , P=0.11 ; and & kgr;=0.09 −0.12 to 0.30 , P=0.32 , respectively ) . Agreement between the 2 POC tests was also poor ( & kgr;=0.14 , −0.08 to 0.36 , P=0.15 ) . Only 2 % of patients were aspirin nonresponders by all 3 tests . Conclusions — The prevalence of apparent ASA nonresponsiveness was higher with both the POC tests than with LTA . However , agreement between the tests was poor and very few patients were ASA nonresponsive by all 3 tests . Aspirin nonresponsiveness is therefore highly test-specific and large prospect i ve studies will be required to determine the prognostic value of each of the separate tests",
"Aspirin , compared with placebo , reduces the risk of cardiovascular events by 25 % in population s of patients with and without known arterial vascular disease . However , the phenomena of ‘ aspirin resistance ’ that has been described in 5–50 % of this population may critically reduce aspirin 's efficacy . One study has suggested that aspirin-resistant patients have a 3.5 times higher risk of cardiovascular death . Presently , there are no established , simple , broadly used methods determining antiplatelet properties of aspirin , while conventional aggregometry requires special equipment and trained personnel . We sought to determine the validity of an Ultegra analyzer with the novel aspirin-sensitive cartridge before and after one pill of non-enteric coated aspirin ( 325 mg ) in subjects with multiple risk factors for coronary artery disease . One hundred and fifty-four volunteers were enrolled into the multicenter study , but six of them were excluded . Data from 148 participants were analyzed . Platelets were assessed twice at baseline ( pre-aspirin ) , and after 2–30 h ( post-aspirin ) . We employed 5 μmol/l epinephrine-induced conventional aggregometry , and aspirin response units stimulated by propyl gallate with the point-of-care Ultegra analyzer . A single pill of aspirin reduced platelet-rich plasma aggregation from 72 ± 21 % to 25 ± 10 % , and diminished aspirin reduction units from 647 ± 95 to 436 ± 69 . The overall agreement between the two methods was 87 % with 85 % sensitivity for Ultegra and 88 % for platelet aggregation , respectively . The correlation between the two methods was 0.902 . Timely determination of aspirin resistance represents an indispensable application in current medicine . The Ultegra RPFA-ASA analyzer is a novel , fast method that could be used in clinical practice for monitoring efficacy of aspirin , and for triaging the aspirin-resistant population . The clinical implication s of these data need to be proven in r and omized trials",
"INTRODUCTION The purpose of the present study was to study the concept of aspirin resistance or non-responsiveness by investigating the response to long-term aspirin therapy in patients with a former acute myocardial infa rct ion ( AMI ) . MATERIAL S AND METHODS Patients with an AMI ( n=202 ) r and omly assigned to aspirin 160 mg/day ( n=71 ) , aspirin 75 mg/day and warfarin ( INR 2.0 - 2.5 ) ( n=58 ) or warfarin ( INR 2.8 - 4.2 ) ( n=73 ) were evaluated by the PFA-100(R ) , biochemical variables and clinical events after a mean treatment period of 4 years . RESULTS The limit for being an aspirin non-responder was defined as the 95th percentile value in the warfarin alone group ( 196 s ) with the epinephrine cartridge . In patients on aspirin alone 25/71 ( 35 % ) were non-responders and on the combination 23/58 ( 40 % ) . With the adenosine diphosphate ( ADP ) cartridge only minor differences were found . The levels of thromboxane B(2 ) in both aspirin groups , in responders as well as in non-responders , were extremely low compared to the warfarin alone group . Evaluating both aspirin groups together ( n=129 ) , the levels of soluble P-selectin were significantly higher in non-responders as compared to responders ( p=0.012 ) . During the observation period of 4 years with limited number of events , there was a tendency for higher event rates in non-responders as compared to responders ( 36 % vs. 24 % , p=0.28 ) . CONCLUSIONS In our evaluation of the PFA-100(R ) a considerable number of post-AMI patients seemed to be non-responders to long-term aspirin therapy in doses of 75 and 160 mg/day . Circulating levels of P-selectin were higher in the non-responders . A tendency to higher incidence of clinical events among non-responders was observed",
"We determined the prevalence and clinical predictors of aspirin resistance by prospect ively study ing 325 patients with stable cardiovascular disease who were receiving aspirin ( 325 mg/day for > or = 7 days ) but no other antiplatelet agents . We also compared the detection of aspirin resistance with optical platelet aggregation , a widely accepted method , with a newer , more rapid method , the platelet function analyzer (PFA)-100 , a whole blood test that measures platelet adhesion and aggregation ex vivo . Blood sample s were analyzed in a blinded fashion for aspirin resistance by optical aggregation using adenosine diphosphate ( ADP ) and arachidonic acid , and by PFA-100 using collagen and /or epinephrine and collagen and /or ADP cartridges to measure aperture closure time . Aspirin resistance was defined as a mean aggregation of > or = 70 % with 10 microM ADP and a mean aggregation of > or = 20 % with 0.5 mg/ml arachidonic acid . Aspirin semiresponders were defined as meeting one , but not both of the above criteria . Aspirin resistance by PFA-100 was defined as having a normal collagen and /or epinephrine closure time ( aspirin resistant and 23.8 % were aspirin semiresponders . By PFA-100 , 9.5 % of patients were aspirin resistant . Of the 18 patients who were aspirin resistant by aggregation , 4 were also aspirin resistant by PFA-100 . Patients who were either aspirin resistant or aspirin semiresponders were more likely to be women ( 34.4 % vs 17.3 % , p = 0.001 ) and less likely to be smokers ( 0 % vs 8.3 % , p = 0.004 ) compared with aspirin-sensitive patients . There was a trend toward increased age in patients with aspirin resistance or aspirin semiresponders ( 65.7 vs 61.3 years , p = 0.06 ) . There were no differences in aspirin sensitivity by race , diabetes , platelet count , renal disease , or liver disease",
"The in vitro closure time ( CT ) , determined by the Platelet Function Analyzer ( PFA‐100TM ) , is used to monitor patients treated with aspirin . A relatively high percentage of in vitro aspirin resistance was reported despite an adequate inhibition of platelet response to arachidonic acid and we investigated whether high plasma levels of von Willebr and factor ristocetin cofactor activity ( vWF : RCo ) may contribute to this profile . Platelet aggregation test , CT [ collagen adrenaline ( CEPI‐CT ) and collagen adenosine 5′‐diphosphate ( ADP ) ( CADP‐CT ) ] , and vWF : RCo levels were evaluated in 55 consecutive patients receiving aspirin ( 75–250 mg/d ) versus 32 untreated control subjects . All the aspirin‐treated patients showed platelet aggregation responses that reflected the aspirin intake . However , CT data analysis enabled aspirin good‐responder ( GR ) and aspirin bad‐responder ( BR ) patients to be identified . All GR group subjects ( n = 27 ) , had a CEPI‐CT and a CADP‐CT longer than 300 s and 96 s respectively . The BR group ( n = 28 ) had CEPI‐CT values below 200 s and all CADP‐CT were in the normal range ( 77 ± 19 s ) . Interestingly , the BR plasma vWF : RCo levels were significantly higher ( 159 ± 43 % ) than those of the GR group ( 121 ± 34 % ) ( P between vWF : RCo and CT values was established . We demonstrate that in vitro aspirin‐resistance , revealed by PFA‐100TM CT prolongation failure , is correlated to increased plasmatic vWF : RCo levels , reinforcing its particular importance in PFA‐100TM cartridges performance",
"Previous studies have shown that more complete platelet inhibition improves the coronary flow reserve ( CFR ) , a measure of microvascular integrity , in patients undergoing percutaneous coronary intervention ( PCI ) . We hypothesized that patients with aspirin resistance would have impaired CFR after elective PCI . We used VerifyNow Aspirin to determine the response to aspirin in 117 consecutive patients who underwent elective single-lesion PCI . The assay results are expressed quantitatively in Aspirin Reaction Units based on the degree of platelet aggregation . All patients received a 300-mg loading dose of clopidogrel > 12 hours before and a 75-mg maintenance dose the morning of PCI . CFR was estimated using the Thrombolysis In Myocardial Infa rct ion frame count method . Of the 117 patients , 22 ( 18.8 % ) were aspirin resistant . The clinical , angiographic , and procedural characteristics of the aspirin-sensitive and -resistant patients were balanced . All patients underwent successful PCI with CFR than the aspirin-sensitive patients ( 1.42 + /- 0.35 vs 1.80 + /- 0.64 , p = 0.018 ) . Univariate correlates of CFR included the Aspirin Reaction Unit ( r = -0.227 , p = 0.014 ) and post-PCI creatine kinase-MB elevation ( p = 0.048 ) . Multivariate linear regression analysis revealed the Aspirin Reaction Unit to be the only independent determinant of CFR after PCI ( r2 = 0.051 , p = 0.014 ) . Thus , aspirin resistance was associated with impaired CFR in patients who underwent elective PCI , implicating insufficient aspirin-induced platelet inhibition as a cause of microvascular dysfunction by distal atherothrombotic embolization and /or spasm",
"The hypothesis that aspirin resistance is often due to noncompliance was investigated . One hundred ninety patients with a history of myocardial infa rct ion were evaluated using arachidonic acid-stimulated light aggregometry at 3 different time points : while receiving their usual daily aspirin , after not receiving aspirin for 7 days , and 2 hours after the observed ingestion of aspirin 325 mg . At the first time point , 17 patients ( 9 % ) failed to show aspirin inhibition of platelet aggregation , but 2 hours after observed aspirin ingestion , aspirin inhibition was observed in all but 1 patient"
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4118284a-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Worldwide at least 100 million people are thought to have prevalent cardiovascular disease ( CVD ) . This population has a five times greater chance of suffering a recurrent cardiovascular event than people without known CVD . Secondary CVD prevention is defined as action aim ed to reduce the probability of recurrence of such events . Drug interventions have been shown to be cost-effective in reducing this risk and are recommended in international guidelines . However , adherence to recommended treatments remains sub-optimal . In order to influence non-adherence , there is a need to develop scalable and cost-effective behaviour-change interventions . OBJECTIVES To assess the effects of mobile phone text messaging in patients with established arterial occlusive events on adherence to treatment , fatal and non-fatal cardiovascular events , and adverse effects . SEARCH METHODS We search ed CENTRAL , MEDLINE , Embase , the Conference Proceedings Citation Index - Science on Web of Science on 7 November 2016 , and two clinical trial registers on 12 November 2016 . We contacted authors of included studies for missing information and search ed reference lists of relevant papers . We applied no language or date restrictions . SELECTION CRITERIA We included r and omised trials with at least 50 % of the participants with established arterial occlusive events . We included trials investigating interventions using short message service ( SMS ) or multimedia messaging service ( MMS ) with the aim to improve adherence to medication for the secondary prevention of cardiovascular events . Eligible comparators were no intervention or other modes of communication . DATA COLLECTION AND ANALYSIS We used st and ard method ological procedures expected by Cochrane . In addition , we attempted to contact all authors on how the SMS were developed . MAIN RESULTS We included seven trials ( reported in 13 reports ) with 1310 participants r and omised . Follow-up ranged from one month to 12 months . Due to heterogeneity in the methods , population and outcome measures , we were unable to conduct meta- analysis on these studies . All seven studies reported on adherence , but using different methods and scales . Six out of seven trials showed a beneficial effect of mobile phone text messaging for medication adherence . Dale 2015a , reported significantly greater medication adherence score in the intervention group ( Mean Difference ( MD ) 0.58 , 95 % confidence interval ( CI ) 0.19 to 0.97 ; 123 participants r and omised ) at six months . Khonsari 2015 reported less adherence in the control group ( Relative Risk ( RR ) 4.09 , 95 % CI 1.82 to 9.18 ; 62 participants r and omised ) at eight weeks . P and ey 2014 ( 34 participants r and omised ) assessed medication adherence through self-reported logs with 90 % adherence in the intervention group compared to 70 % in the control group at 12 months . Park 2014a ( 90 participants r and omised ) reported a greater increase of the medication adherence score in the control group , but also measured adherence with an event monitoring system for a number of medications with adherence levels ranging from 84.1 % adherence to 86.2 % in the intervention group and 79.7 % to 85.7 % in the control group at 30 days . Quilici 2013 , reported reduced odds of non-adherence in the intervention group ( Odds Ratio ( OR ) 0.43 , 95 % CI 0.22 to 0.86 , 521 participants r and omised ) at 30 days . Fang 2016 , reported that participants given SMS alone had reduced odds of being non-adherent compared to telephone reminders ( OR 0.40 95 % CI 0.18 to 0.63 ; 280 patients r and omised ) . Kamal 2015 reported higher levels of adherence in the intervention arm ( adjusted MD 0.54 , 95 % CI 0.22 to 0.85 ; 200 participants r and omised ) . Khonsari 2015 was the only study to report fatal cardiovascular events and only reported two events , both in the control arm . No study reported on the other primary outcomes . No study reported repetitive thumb injury or road traffic crashes or other adverse events that were related to the intervention . Four authors replied to our question naire on SMS development . No study reported examining causes of non-adherence or provided SMS tailored to individual patient characteristics . The included studies were small , heterogeneous and included participants recruited directly after acute events . All studies were assessed as having high risk of bias across at least one domain . Most of the studies came from high-income countries , with two studies conducted in an upper middle-income country ( China , Malaysia ) , and one study from a lower middle-income country ( Pakistan ) . The quality of the evidence was found to be very low . There was no obvious conflicts of interest from authors , although only two declared their funding . AUTHORS ' CONCLUSIONS While the results of this systematic review are promising , there is insufficient evidence to draw conclusions on the effectiveness of text message-based interventions for adherence to medications for secondary prevention of CVD . Sufficiently powered , high- quality r and omised trials are needed , particularly in low- and middle-income countries
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[
"AIMS AND OBJECTIVES To compare drug adherence to lipid-lowering therapy among out patients with coronary artery disease who received information via short message service , via short message service and Micro Letter , or via phone only . BACKGROUND Messaging applications and short message service are commonly used internationally . However , little is known about how coronary artery disease out patients in China may benefit from receiving health education through these technologies . DESIGN R and om sampling method . METHODS Data were collected from March-December 2013 . Subjects from Chengdu City , China , were r and omised to three groups : short message service , short message service + Micro Letter , and phone ( control ) . Appointment reminders and health information were delivered to patients in accordance with design ations . After six months , adherence to statin prescriptions was compared among the groups by using the Morisky Medication Adherence Scale . Logistic regression analysis was applied to determine those independent variables that were related to adherence . RESULTS The short message service and short message service + Micro Letter groups had better cumulative adherence ( lower Morisky Medication Adherence Scale scores ) after six months than phone group , and the short message service + Micro Letter group had better cumulative adherence ( lower Morisky Medication Adherence Scale scores ) than the short message service group . Female sex , older age and marriage show positive associations with adherence . CONCLUSIONS Short message service and messaging applications , such as Micro Letter , are effective means of providing discharged patients with reminders and coronary artery disease-related health information . Implementation of a short message service + Micro Letter program can improve outpatient adherence to medication . RELEVANCE TO CLINICAL PRACTICE This research offers useful information to help medical staff design effective interventions to improve medication compliance among coronary artery disease patients",
"Background Stroke is a major cause of morbidity and mortality , especially in low and middle income countries . Medical management is the mainstay of therapy to prevent recurrence of stroke . Current estimates are that only 1 in 6 patients have perfect adherence to medication schedules . Using SMS ( Short Messaging Service ) as reminders to take medicines have been used previously for diseases such as diabetes and HIV with moderate success . We aim to explore the effectiveness and acceptability of SMS in increasing adherence to medications in patients with stroke . Methods This will be a r and omized , controlled , assessor blinded single center superiority trial . Adult participants with access to a cell phone and a history of stroke longer than 1 month on multiple risk modifying medications will be selected from Neurology and Stroke Clinic . They will be r and omized into two parallel groups in a 1:1 ratio via block technique with one group receiving the st and ard of care as per institutional guidelines while the parallel group receiving SMS reminders for each dose of medicine in addition to the st and ard of care . In addition intervention group will receive messages for lifestyle changes , medication information , risk factors and motivation for medication adherence . These will bemodeled on Social Cognitive Theory and Health Belief Model and will be categorized by Michies Taxonomy of Behavioral Change Communication . Patient compliance to medicines will be measured at baseline and then after 2 months in each group by using the Morisky Medication Adherence Scale . The change in compliance to medication regimen after the intervention and the difference between the two groups will be used to determine the effectiveness of SMS reminders as a tool to increase medication compliance . The acceptability of the SMS will be determined by a tool design ed for this study whose attributes are based Rogers Diffusion of innovation theory . A sample size of 86 participants in each arm will be sufficient to detect a difference of 1 point on the MMAS with a power of 90 % and significance level of 5 % between the two groups ; using an attrition rate of 15 % , 200 participants in all will be r and omized . Discussion The SMS for Stroke Study will provide evidence for feasibility and effectiveness of SMS in improving post stroke medication adherence in an LMIC setting .Trial registration https:// clinical trials.gov/ct2/show/NCT01986023 11",
"Background Although supporting lifestyle change is an effective way of preventing further events in people with cardiovascular disease , providing access to such interventions is a major challenge . This study aims to investigate whether simple reminders about behaviour change sent via mobile phone text message decrease cardiovascular risk . Methods and analysis R and omised controlled trial with 6 months of follow-up to evaluate the feasibility , acceptability and effect on cardiovascular risk of repeated lifestyle reminders sent via mobile phone text messages compared to usual care . A total of 720 patients with coronary artery disease will be r and omised to either st and ard care or the TEXT ME intervention . The intervention group will receive multiple weekly text messages that provide information , motivation , support to quit smoking ( if relevant ) and recommendations for healthy diets and exercise . The primary end point is a change in plasma low-density lipoprotein cholesterol at 6 months . Secondary end points include a change in systolic blood pressure , smoking status , quality of life , medication adherence , waist circumference , physical activity levels , nutritional status and mood at 6 months . Process outcomes related to acceptability and feasibility of TEXT ME will also be collected . Ethics and dissemination Primary ethics approval was received from Western Sydney Local Health Network Human Research Ethics Committee — Westmead . Results will be disseminated via the usual scientific forums including peer- review ed publications and presentations at international conferences . Clinical trials registration number ACTRN12611000161921",
"Aim To determine the effectiveness and cost-effectiveness of a mobile phone intervention to improve exercise capacity and physical activity behaviour in people with ischaemic heart disease ( IHD ) . Methods and results In this single-blind , parallel , two-arm , r and omized controlled trial adults ( n = 171 ) with IHD were r and omized to receive a mobile phone delivered intervention ( HEART ; n = 85 ) plus usual care , or usual care alone ( n = 86 ) . Adult participants aged 18 years or more , with a diagnosis of IHD , were clinical ly stable as out patients , able to perform exercise , able to underst and and write English , and had access to the Internet . The HEART ( Heart Exercise And Remote Technologies ) intervention involved a personalized , automated package of text messages and a secure website with video messages aim ed at increasing exercise behaviour , delivered over 24 weeks . All participants were able to access usual community-based cardiac rehabilitation , which involves encouragement of physical activity and an offer to join a local cardiac support club . All outcomes were assessed at baseline and 24 weeks and included peak oxygen uptake ( PVO2 ; primary outcome ) , self-reported physical activity , health-related quality of life , self-efficacy and motivation ( secondary outcomes ) . Results showed no differences in PVO2 between the two groups ( difference −0.21 ml kg−1 min−1 , 95 % CI : −1.1 , 0.7 ; p = 0.65 ) at 24 weeks . However significant treatment effects were observed for selected secondary outcomes , including leisure time physical activity ( difference 110.2 min/week , 95 % CI : −0.8 , 221.3 ; p = 0.05 ) and walking ( difference 151.4 min/week , 95 % CI : 27.6 , 275.2 ; p = 0.02 ) . There were also significant improvements in self-efficacy to be active ( difference 6.2 % , 95 % CI : 0.2 , 12.2 ; p = 0.04 ) and the general health domain of the SF36 ( difference 2.1 , 95 % CI : 0.1 , 4.1 ; p = 0.03 ) at 24 weeks . The HEART programme was considered likely to be cost-effective for leisure time activity and walking . Conclusions A mobile phone intervention was not effective at increasing exercise capacity over and above usual care . The intervention was effective and probably cost-effective for increasing physical activity and may have the potential to augment existing cardiac rehabilitation services",
"Background Despite the known positive effects of cardiac rehabilitation and an active lifestyle , evidence is emerging that it is difficult to attain and sustain the minimum recommendations of leisure time physical activity . The long-term benefits are often disappointing due to lack of adherence to the changes in life style . Qualitative research on patients ’ perspectives suggests that motivation for lifestyle change tends to diminish around 3 months after the index-event . The time most cardiac rehabilitation programmes end . The aim of the present study is to determine if prolongation of a traditional cardiac rehabilitation programme with additional heart rate based telemonitoring guidance for a period of 6 months results in better long term effects on physical and mental outcomes , care consumption and quality of life than traditional follow-up . Methods In this single centre r and omised controlled trial 120 patients with an absolute indication for cardiac rehabilitation will be r and omised in a 1:1 ratio to an intervention group with 6 months of heart rate based telemonitoring guidance or a control group with traditional follow-up after cardiac rehabilitation . The primary endpoint will be VO2peak after 12 months . Secondary endpoints are VO2peak after 6 months , quality of life , physical- , emotional- and social functioning , cardiac structure , traditional risk profile , compliance to the use of the heart rate belt and smartphone , MACE and care-consumption . Discussion The TeleCaRe study will provide insight into the added value of the prolongation of traditional cardiac rehabilitation with 6 months of heart rate based telemonitoring guidance . Trial registration Dutch Trial Register : NTR4644 ( registered 06/12/14 )",
"OBJECTIVES The purpose of this study was to assess the rate of death and hospitalization for heart failure ( HF ) 1 and 3 years after a r and omized trial of telephone intervention aim ed to improve education and compliance in stable patients with HF ended . BACKGROUND The long-term effects of HF programs are not well known . METHODS In all , 1,518 patients with HF were r and omized into the DIAL ( R and omized Trial of Phone Intervention in Chronic Heart Failure ) . After completion of the trial , patients were followed up to 3 years to assess major outcomes . Compliance with diet , weight control , and treatment was evaluated . The effect of the intervention on mortality and HF hospitalizations was assessed using relative risk ( RR ) , relative risk reduction , and Cox proportional hazards model for adjusting by potential confounders . RESULTS The rate of death or hospitalization for HF was lower in the intervention group ( 37.2 % vs. 42.6 % , RR : 0.81 , 95 % confidence interval [ CI ] : 0.69 to 0.96 ; p = 0.013 ) 1 and 3 years ( 55.7 % vs. 57.5 % , RR : 0.88 , 95 % CI : 0.77 to 1.00 ; p = 0.05 ) after the intervention ended . This benefit was mainly caused by a reduction in admission for HF ( 28.5 % vs. 35.1 % after 3 years , RR : 0.72 , 95 % CI : 0.60 to 0.87 ; p = 0.0004 ) . Patients who showed improvement in 1 or more of 3 key compliance indicators ( diet , weight control , and medication ) had lower risks of events . CONCLUSIONS The benefit observed during the intervention period persisted and was sustained 1 and 3 years after the intervention ended . This effect may be explained by the impact of the educational intervention on patients ' behavior and habits",
"Background There is a strong will and need to find alternative models of health care delivery driven by the ever-increasing burden of chronic diseases . Objective The purpose of this 1-year trial was to study whether a structured mobile phone-based health coaching program , which was supported by a remote monitoring system , could be used to improve the health-related quality of life ( HRQL ) and /or the clinical measures of type 2 diabetes and heart disease patients . Methods A r and omized controlled trial was conducted among type 2 diabetes patients and heart disease patients of the South Karelia Social and Health Care District . Patients were recruited by sending invitations to r and omly selected patients using the electronic health records system . Health coaches called patients every 4 to 6 weeks and patients were encouraged to self-monitor their weight , blood pressure , blood glucose ( diabetics ) , and steps ( heart disease patients ) once per week . The primary outcome was HRQL measured by the Short Form ( 36 ) Health Survey ( SF-36 ) and glycosylated hemoglobin ( HbA1c ) among diabetic patients . The clinical measures assessed were blood pressure , weight , waist circumference , and lipid levels . Results A total of 267 heart patients and 250 diabetes patients started in the trial , of which 246 and 225 patients concluded the end-point assessment s , respectively . Withdrawal from the study was associated with the patients ’ unfamiliarity with mobile phones — of the 41 dropouts , 85 % ( 11/13 ) of the heart disease patients and 88 % ( 14/16 ) of the diabetes patients were familiar with mobile phones , whereas the corresponding percentages were 97.1 % ( 231/238 ) and 98.6 % ( 208/211 ) , respectively , among the rest of the patients ( P=.02 and P=.004 ) . Withdrawal was also associated with heart disease patients ’ comorbidities—40 % ( 8/20 ) of the dropouts had at least one comorbidity , whereas the corresponding percentage was 18.9 % ( 47/249 ) among the rest of the patients ( P=.02 ) . The intervention showed no statistically significant benefits over the current practice with regard to health-related quality of life — heart disease patients : beta=0.730 ( P=.36 ) for the physical component score and beta=-0.608 ( P=.62 ) for the mental component score ; diabetes patients : beta=0.875 ( P=.85 ) for the physical component score and beta=-0.770 ( P=.52 ) for the mental component score . There was a significant difference in waist circumference in the type 2 diabetes group ( beta=-1.711 , P=.01 ) . There were no differences in any other outcome variables . Conclusions A health coaching program supported with telemonitoring did not improve heart disease patients ' or diabetes patients ' quality of life or their clinical condition . There were indications that the intervention had a differential effect on heart patients and diabetes patients . Diabetes patients may be more prone to benefit from this kind of intervention . This should not be neglected when developing new ways for self-management of chronic diseases . Trial Registration Clinical Trials.gov NCT01310491 ; http:// clinical trials.gov/ct2/show/NCT01310491 ( Archived by WebCite at http://www.webcitation.org/6Z8l5FwAM )",
"Background Vascular disease , manifesting as myocardial infa rct ion and stroke , is a major cause of morbidity and mortality , especially in low- and middle-income countries . Current estimates are that only one in six patients have good adherence to medications and very few have sufficient health literacy . Our aim is to explore the effectiveness and acceptability of Prescription Interactive Voice Response ( IVR ) Talking Prescriptions ( Talking Rx ) and SMS reminders in increasing medication adherence and health literacy in Pakistani patients with vascular disease . Methods This is a r and omized , controlled , single center trial . Adult participants , with access to a cell phone and a history of vascular disease , taking multiple risk-modifying medications ( inclusive of anti-platelets and statins ) will be selected from cerebrovascular and cardiovascular clinics . They will be r and omized in a 1:1 ratio via a block design to the intervention or the control arm with both groups having access to a helpline number to address their queries in addition to st and ard of care as per institutional guidelines . Participants in the intervention group will also have access to Interactive Voice Response ( IVR ) technology tailored to their respective prescriptions in the native language ( Urdu ) and will have the ability to hear information about their medication dosage , correct use , side effects , mechanism of action and how and why they should use their medication , as many times as they like . Participants in the intervention arm will also receive scheduled SMS messages reminding them to take their medications . The primary outcome measure will be the comparison of the difference in adherence to anti-platelet and statin medication between baseline and at 3-month follow-up in each group measured by the Morisky Medication Adherence Scale . To ascertain the impact of our intervention on health literacy , we will also compare a local content-vali date d and modified version of Test of Health Literacy in Adults ( TOFHLA ) between the intervention and the control arm . We estimate that a sample size of 86 participants in each arm will be able to detect a difference of 1 point on the MMAS with a power of 90 % and significance level of 5 % . Accounting for an attrition rate of 15 % , we plan to enroll 100 participants in each arm ( total study population = 200 ) . We hypothesize that a linguistically tailored health IT intervention based on IVR and SMS will be associated with an improvement in adherence ( to anti-platelet and lipid-lowering medications ) and an improvement in health literacy in Pakistani patients with vascular disease . Discussion This innovative study will provide early data for the feasibility of the use of IT based prescriptions in an lower middle incorme country setting with limited numeracy and literacy skills . Trial registration Clinical Trials.gov : NCT02354040 − 2 February",
"Background — Adherence to cardioprotective medications in the year after acute coronary syndrome hospitalization is generally poor and is associated with increased risk of rehospitalization and mortality . Few interventions have specifically targeted this high-risk patient population to improve medication adherence . We hypothesize that a multifaceted patient-centered intervention could improve adherence to cardioprotective medications . Methods and Results — To evaluate this intervention , we propose enrolling 280 patients with a recent acute coronary syndrome event into a multicenter r and omized , controlled trial . The intervention comprises4 main components : ( 1 ) pharmacist-led medication reconciliation and tailoring ; ( 2 ) patient education ; ( 3 ) collaborative care between pharmacist and primary care provider/cardiologist ; and ( 4 ) 2 types of voice messaging ( educational and medication refill reminder calls ) . Patients in the intervention arm will visit with the study pharmacist ≈1 week post-hospital discharge . The pharmacist will work with the patient and collaborate with providers to reconcile medication issues . Voice messages will augment the educational process and remind patients to refill their cardioprotective medications . The study will compare the intervention versus usual care for 12 months . The primary outcome of interest is adherence using the ReComp method . Secondary and tertiary outcomes include achievement of targets for blood pressure and low-density lipoprotein , and reduction in the combined cardiovascular end points of myocardial infa rct ion hospitalization , coronary revascularization , and all-cause mortality . Finally , we will also evaluate the cost-effectiveness of the intervention compared with usual care . Conclusions — If the intervention is effective in improving medication adherence and demonstrating a lower cost , the intervention has the potential to improve cardiovascular outcomes in this high-risk patient population",
"Background Chronic heart failure ( HF ) disease management programs have reported inconsistent results and have not included comorbid depression management or specifically focused on improving patient-reported outcomes . The Patient Centered Disease Management ( PCDM ) trial was design ed to test the effectiveness of collaborative care disease management in improving health status ( symptoms , functioning , and quality of life ) in patients with HF who reported poor HF-specific health status . Methods / design Patients with a HF diagnosis at four VA Medical Centers were identified through population -based sampling . Patients with a Kansas City Cardiomyopathy Question naire ( KCCQ , a measure of HF-specific health status ) score of . Enrolled patients were r and omized to receive usual care or the PCDM intervention , which included : ( 1 ) collaborative care management by VA clinicians including a nurse , cardiologist , internist , and psychiatrist , who worked with patients and their primary care providers to provide guideline -concordant care management , ( 2 ) home telemonitoring and guided patient self-management support , and ( 3 ) screening and treatment for comorbid depression . The primary study outcome is change in overall KCCQ score . Secondary outcomes include depression , medication adherence , guideline -based care , hospitalizations , and mortality . Discussion The PCDM trial builds on previous studies of HF disease management by prioritizing patient health status , implementing a collaborative care model of health care delivery , and addressing depression , a key barrier to optimal disease management . The study has been design ed as an ‘ effectiveness trial ’ to support broader implementation in the healthcare system if it is successful . Trial registration Unique identifier :",
"Background Patients with cardiovascular diseases managed by a person-centered care ( PCC ) approach have been observed to have better treatment outcomes and satisfaction than with traditional care . eHealth may facilitate the often slow transition to more person-centered health care by increasing patients ’ beliefs in their own capacities ( self-efficacy ) to manage their care trajectory . eHealth is being increasingly used , but most studies continue to focus on health care professionals ’ logic of care . Knowledge is lacking regarding the effects of an eHealth tool on self-efficacy when combined with PCC for patients with chronic heart diseases . Objective The objective of our study was to investigate the effect of an eHealth diary and symptom-tracking tool in combination with PCC for patients with acute coronary syndrome ( ACS ) . Methods This was a sub study of a r and omized controlled trial investigating the effects of PCC in patients hospitalized with ACS . In total , 199 patients with ACS aged were r and omly assigned to a PCC intervention ( n=94 ) or st and ard treatment ( control group , n=105 ) and were followed up for 6 months . Patients in the intervention arm could choose to use a Web-based or mobile-based eHealth tool , or both , for at least 2 months after hospital discharge . The primary end point was a composite score of changes in general self-efficacy , return to work or prior activity level , and rehospitalization or death 6 months after discharge . Results Of the 94 patients in the intervention arm , 37 ( 39 % ) used the eHealth tool at least once after the index hospitalization . Most of these ( 24/37 , 65 % ) used the mobile app and not the Web-based app as the primary source of daily self-rating input . Patients used the eHealth tool a mean of 38 times during the first 8 weeks ( range 1–118 , SD 33 ) and 64 times over a 6-month period ( range 1–597 , SD 104 ) . Patients who used the eHealth tool in combination with the PCC intervention had a 4-fold improvement in the primary end point compared with the control group ( odds ratio 4.0 , 95 % CI 1.5–10.5 ; P=.005 ) . This improvement was driven by a significant increase in general self-efficacy compared with the control group ( P=.011 ) . Patients in the PCC group who did not use the eHealth tool ( n=57 ) showed a nonsignificant composite score improvement compared with those in the control group ( n=105 ) ( odds ratio 2.0 , 95 % CI 0.8–5.2 ; P=.14 ) . Conclusions We found a significant effect on improved general self-efficacy and the composite score for patients using an eHealth diary and symptom-tracking tool in combination with PCC compared with traditional care . Trial Registration Swedish registry , Research web.org , ID NR 65 791",
"Objective Cardiac rehabilitation ( CR ) is pivotal in preventing recurring events of myocardial infa rct ion ( MI ) . This study aims to investigate the effect of a smartphone-based home service delivery ( Care Assessment Platform ) of CR ( CAP-CR ) on CR use and health outcomes compared with a traditional , centre-based programme ( TCR ) in post-MI patients . Methods In this unblinded r and omised controlled trial , post-MI patients were r and omised to TCR ( n=60 ; 55.7±10.4 years ) and CAP-CR ( n=60 ; 55.5±9.6 years ) for a 6-week CR and 6-month self-maintenance period . CAP-CR , delivered in participants ’ homes , included health and exercise monitoring , motivational and educational material delivery , and weekly mentoring consultations . CAP-CR uptake , adherence and completion rates were compared with TCR using intention-to-treat analyses . Changes in clinical outcomes ( modifiable lifestyle factors , biomedical risk factors and health-related quality of life ) across baseline , 6 weeks and 6 months were compared within , and between , groups using linear mixed model regression . Results CAP-CR had significantly higher uptake ( 80 % vs 62 % ) , adherence ( 94 % vs 68 % ) and completion ( 80 % vs 47 % ) rates than TCR ( p improvements in 6-minute walk test from baseline to 6 weeks ( TCR : 537±86–584±99 m ; CAP-CR : 510±77–570±80 m ) , which was maintained at 6 months . CAP-CR showed slight weight reduction ( 89±20–88±21 kg ) and also demonstrated significant improvements in emotional state ( K10 : median ( IQR ) 14.6 ( 13.4–16.0 ) to 12.6 ( 11.5–13.8 ) ) , and quality of life ( EQ5D-Index : median ( IQR ) 0.84 ( 0.8–0.9 ) to 0.92 ( 0.9–1.0 ) ) at 6 weeks . Conclusions This smartphone-based home care CR programme improved post-MI CR uptake , adherence and completion . The home-based CR programme was as effective in improving physiological and psychological health outcomes as traditional CR . CAP-CR is a viable option towards optimising use of CR services . Trial registration number ANZCTR12609000251224",
"BACKGROUND Managing patients with heart failure ( HF ) is labor intensive , and follow-up is often inadequate to detect day-to-day changes that ultimately lead to decompensation . We tested the effect of an Internet-based telemedicine ( T ) system that provides frequent surveillance and increased communicate between HF patients and their provider on frequency of hospitalization in a cohort of patients with advanced HF . METHODS AND RESULTS HF patients in NYHA Class II-IV were r and omized to usual care ( UC , n = 24 ) or T ( T plus UC , n = 24 ) and followed for 1 year . Office visits , emergency department visits , hospitalizations , telephone calls , and number of Internet communications were measured over the 1-year period . Left ventricular ejection fraction ( EF ) was assessed by echocardiography in both groups . For T , mean age was 53.2 + /- 2.0 years ( 72 % male , 61 % Caucasian , 39 % African American ) . For UC , mean age was 54.1 + /- 2.6 years ( 76 % male , 72 % Caucasian , 14 % African American , and 14 % Hispanic ) . HF etiologies and EF were similar in both groups . During the 12-month period , UC had 74 total phone calls to the practice , whereas T had 88 telephone calls plus 1887 telemedicine data messages ( 6.5 messages/patient/month ) . ER visits were lower in the T group ( T 5 , UC 12 ; P Hospital admissions ( T 24 , C 40 ; P = .025 ) and total hospital days ( T 84 , UC 226 days ; P Unscheduled clinic visits ( T 13 , UC 13 ; P = NS ) and scheduled clinic visits ( T 78 , UC 94 ; P = NS ) were similar in both groups . CONCLUSIONS Frequent monitoring and patient management using a telemedicine system may help to reduce hospitalizations , hospital days , and emergency department visits",
"Background In New Zeal and , around 45,000 people live with stroke and many studies have reported that benefits gained during initial rehabilitation are not sustained . Evidence indicates that participation in physical interventions can prevent the functional decline that frequently occurs after discharge from acute care facilities . However , on-going stroke services provision following discharge from acute care is often related to non-medical factors such as availability of re sources and geographical location . Currently most people receive no treatment beyond three months post stroke . The study aims to determine if the Augmented Community Telerehabilitation Intervention ( ACTIV ) results in better physical function for people with stroke than usual care , as measured by the Stroke Impact Scale , physical subcomponent . Methods / design This study will use a multi-site , two-arm , assessor blinded , parallel r and omised controlled trial design . People will be eligible if they have had their first ever stroke , are over 20 and have some physical impairment in either arm or leg , or both . Following discharge from formal physiotherapy services ( inpatient , outpatient or community ) , participants will be r and omised into ACTIV or usual care . ACTIV uses readily available technology , telephone and mobile phones , combined with face-to-face visits from a physiotherapist over a six-month period , to help people with stroke resume activities they enjoyed before the stroke . The impact of stroke on physical function and quality of life will be assessed , measures of cost will be collected and a discrete choice survey will be used to measure preferences for rehabilitation options . These outcomes will be collected at baseline , six months and 12 months . In-depth interviews will be used to explore the experiences of people participating in the intervention arm of the study . Discussion The lack of on-going rehabilitation for people with stroke diminishes the chance of their best possible outcome and may contribute to a functional decline following discharge from formal rehabilitation . Best practice guidelines recommend a prolonged period of rehabilitation , however this is expensive and therefore not undertaken in most publicly funded centres . An effective , cost-effective , and preference-sensitive therapy using basic technology to assist programme delivery may improve patient autonomy as they leave formal rehabilitation and return home . Trial registration",
"Remote monitoring ( RM ) of homebound heart failure ( HF ) patients has previously been shown to reduce hospital admissions . We conducted a pilot trial of ambulatory , non-homebound patients recently hospitalized for HF to determine whether RM could be successfully implemented in the ambulatory setting . Eligible patients from Massachusetts General Hospital ( n = 150 ) were r and omized to a control group ( n = 68 ) or to a group that was offered RM ( n = 82 ) . The participants transmitted vital signs data to a nurse who coordinated care with the physician over the course of the 6-month study . Participants in the RM program had a lower all-cause per person readmission rate ( mean = 0.64 , SD ± 0.87 ) compared to the usual care group ( mean = 0.73 , SD ± 1.51 ; P-value = .75 ) although the difference was not statistically significant . HF-related readmission rate was similarly reduced in participants . This pilot study demonstrates that RM can be successfully implemented in non-homebound HF patients and may reduce readmission rates ",
"Background Previous trials of telemonitoring for heart failure management have reported inconsistent results , largely due to diverse intervention and study design s. Mobile phones are becoming ubiquitous and economical , but the feasibility and efficacy of a mobile phone-based telemonitoring system have not been determined . Objective The objective of this trial was to investigate the effects of a mobile phone-based telemonitoring system on heart failure management and outcomes . Methods One hundred patients were recruited from a heart function clinic and r and omized into telemonitoring and control groups . The telemonitoring group ( N = 50 ) took daily weight and blood pressure readings and weekly single-lead ECGs , and answered daily symptom questions on a mobile phone over 6 months . Readings were automatically transmitted wirelessly to the mobile phone and then to data servers . Instructions were sent to the patients ’ mobile phones and alerts to a cardiologist ’s mobile phone as required . Results Baseline question naires were completed and returned by 94 patients , and 84 patients returned post- study question naires . About 70 % of telemonitoring patients completed at least 80 % of their possible daily readings . The change in quality of life from baseline to post- study , as measured with the Minnesota Living with Heart Failure Question naire , was significantly greater for the telemonitoring group compared to the control group ( P = .05 ) . A between-group analysis also found greater post- study self-care maintenance ( measured with the Self-Care of Heart Failure Index ) for the telemonitoring group ( P = .03 ) . Brain natriuretic peptide ( BNP ) levels , self-care management , and left ventricular ejection fraction ( LVEF ) improved significantly for both groups from baseline to post- study , but did not show a between-group difference . However , a subgroup within-group analysis using the data from the 63 patients who had attended the heart function clinic for more than 6 months revealed the telemonitoring group had significant improvements from baseline to post- study in BNP ( decreased by 150 pg/mL , P = .02 ) , LVEF ( increased by 7.4 % , P = .005 ) and self-care maintenance ( increased by 7 points , P = .05 ) and management ( increased by 14 points , P = .03 ) , while the control group did not . No differences were found between the telemonitoring and control groups in terms of hospitalization , mortality , or emergency department visits , but the trial was underpowered to detect differences in these metrics . Conclusions Our findings provide evidence of improved quality of life through improved self-care and clinical management from a mobile phone-based telemonitoring system . The use of the mobile phone-based system had high adherence and was feasible for patients , including the elderly and those with no experience with mobile phones . Trial Registration Clinical Trials.gov",
"Background Atrial fibrillation is a major public health problem and is the most common cardiac arrhythmia , affecting an estimated 2.7 million Americans . The true prevalence of atrial fibrillation is likely underestimated because episodes are often sporadic ; therefore , it is challenging to detect and record an occurrence in a “ real world ” setting . To date , mobile health tools that promote earlier detection and treatment of atrial fibrillation and improvement in self-management behaviors and knowledge have not been evaluated . This study will be the first to address the epidemic problem of atrial fibrillation with a novel approach utilizing advancements in mobile health electrocardiogram technology to empower patients to actively engage in their healthcare and to evaluate impact on quality of life and quality -adjusted life years . Furthermore , sending a daily electrocardiogram transmission , coupled with receiving educational and motivational text messages aim ed at promoting self-management and a healthy lifestyle may improve the management of chronic cardiovascular conditions ( e.g. , hypertension , diabetes , heart failure , etc . ) . Therefore , we are currently conducting a r and omized controlled trial to assess the efficacy of a mobile health intervention , iPhone ® Helping Evaluate Atrial fibrillation Rhythm through Technology ( iHEART ) versus usual cardiac care . Methods The iHEART study is a single center , prospect i ve , r and omized controlled trial . A total of 300 participants with a recent history of atrial fibrillation will be enrolled . Participants will be r and omized 1:1 to receive the iHEART intervention , receiving an iPhone ® equipped with an AliveCor ® Mobile ECG and accompanying Kardia application and behavioral altering motivational text messages or usual cardiac care for 6 months . Discussion This will be the first study to investigate the utility of a mobile health intervention in a “ real world ” setting . We will evaluate the ability of the iHEART intervention to improve the detection and treatment of recurrent atrial fibrillation and assess the intervention 's impact on improving clinical outcomes , quality of life , quality -adjusted life-years and disease-specific knowledge . Trial registration NCT02731326 ; Verified April",
"Background The effectiveness of mobile technology to improve medication adherence via customized Short Messaging Service ( SMS ) reminders for stroke has not been tested in re source poor areas . We design ed a r and omized controlled trial to test the effectiveness of SMS on improving medication adherence in stroke survivors in Pakistan . Methods This was a parallel group , assessor-blinded , r and omized , controlled , superiority trial . Participants were central ly r and omized in fixed block sizes . Adult participants on multiple medications with access to a cell phone and stroke at least 4 weeks from onset ( Onset as defined by last seen normal ) were eligible . The intervention group , in addition to usual care , received reminder SMS for 2 months that contained a ) Personalized , prescription tailored daily medication reminder(s ) b ) Twice weekly health information SMS . The Health Belief Model and Social Cognitive theory were used to design the language and content of messages . Frontline SMS software was used for SMS delivery . Medication adherence was self-reported and measured on the vali date d Urdu version of Morisky Medication Adherence Question naire . Multiple linear regression was used to model the outcome against intervention and other covariates . Analysis was conducted by intention-to-treat principle . Results Two hundred participants were enrolled . 38 participants were lost to follow-up . After 2 months , the mean medication score was 7.4 ( 95 % CI : 7.2–7.6 ) in the intervention group while 6.7 ( 95 % CI : 6.4–7.02 ) in the control group . The adjusted mean difference ( Δ ) was 0.54 ( 95 % CI : 0.22–0.85 ) . The mean diastolic blood pressure in the intervention group was 2.6 mmHg ( 95 % CI ; −5.5 to 0.15 ) lower compared to the usual care group . Conclusion A short intervention of customized SMS can improve medication adherence and effect stroke risk factors like diastolic blood pressure in stroke survivors with complex medication regimens living in re source poor areas .Trial registration Clinical trials.gov NCT01986023 last accessed at https:// clinical",
"Background — We assessed the effect of automated treatment adherence support delivered via mobile phone short message system ( SMS ) text messages on blood pressure . Methods and Results — In this pragmatic , single-blind , 3-arm , r and omized trial ( SMS-Text Adherence Support [ StAR ] ) undertaken in South Africa , patients treated for high blood pressure were r and omly allocated in a 1:1:1 ratio to information only , interactive SMS text messaging , or usual care . The primary outcome was change in systolic blood pressure at 12 months from baseline measured with a vali date d oscillometric device . All trial staff were masked to treatment allocation . Analyses were intention to treat . Between June 26 , 2012 , and November 23 , 2012 , 1372 participants were r and omized to receive information-only SMS text messages ( n=457 ) , interactive SMS text messages ( n=458 ) , or usual care ( n=457 ) . Primary outcome data were available for 1256 participants ( 92 % ) . At 12 months , the mean adjusted change in systolic blood pressure compared with usual care was −2.2 mm Hg ( 95 % confidence interval , −4.4 to −0.04 ) with information-only SMS and −1.6 mm Hg ( 95 % confidence interval , −3.7 to 0.6 ) with interactive SMS . Odds ratios for the proportion of participants with a blood pressure general outpatient population of adults with high blood pressure , we found a small reduction in systolic blood pressure control compared with usual care at 12 months . There was no evidence that an interactive intervention increased this effect . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT02019823 . South African National Clinical Trials Register , number SANCTR DOH-27 - 1212 - 386 ; Pan Africa Trial Register , number PACTR201411000724141",
"Background Unintentional non-adherence has been characterized as passively inconsistent medication-taking behavior ( forgetfulness or carelessness ) . Our objectives were to : ( 1 ) study the prevalence and predictors of unintentional non-adherence ; and ( 2 ) explore the interrelationship between intentional and unintentional non-adherence in relation to patients ’ medication beliefs . Methods We conducted a cross-sectional survey of adults with asthma , hypertension , diabetes , hyperlipidemia , osteoporosis , or depression from the Harris Interactive Chronic Illness Panel . The analytic sample for this study included 24,017 adults who self-identified themselves as persistent to prescription medications for their index disease . They answered three questions on unintentional non-adherence ( forgot , ran out , being careless ) , 11 questions on intentional non-adherence , and three multi-item scales assessing perceived need for medication ( k = 10 ) , perceived medication concerns ( k = 6 ) , and perceived medication affordability ( k = 4 ) . Logistic regression was used to model predictors of each unintentional non-adherence behavior . Baron and Kenny ’s regression approach was used to test the mediational effect of unintentional non-adherence on the relationship between medication beliefs and intentional non-adherence . Bootstrapping was employed to confirm the statistical significance of these results . Results For the index disease , 62 % forgot to take a medication , 37 % had run out of the medication , and 23 % were careless about taking the medication . Common multivariate predictors ( p lower perceived need for medications ; ( 2 ) more medication affordability problems ; ( 3 ) worse self-rated health ; ( 4 ) diabetes or osteoporosis ( relative to hypertension ) ; and ( 5 ) younger age . Unique statistically-significant predictors of the three behaviors were : ( a ) ‘ forgot to take medications ’ - greater concerns about the index medication and male gender ; ( b ) ‘ run out of medications ’ - non-white race , asthma , and higher number of total prescription medications ; ( c ) ‘ being careless ’ - greater medication concerns . Mediational tests confirmed the hypothesis that the effect of medication beliefs ( perceived need , concerns , and affordability ) on intentional non-adherence is mediated through unintentional non-adherence . Conclusions For our study sample , unintentional non-adherence does not appear to be r and om and is predicted by medication beliefs , chronic disease , and sociodemographics . The data suggests that the importance of unintentional non-adherence may lie in its potential prognostic significance for future intentional non-adherence . Health care providers may consider routinely inquiring about unintentional non-adherence in order to proactively address patients ’ suboptimal medication beliefs before they choose to discontinue therapy all together",
"BACKGROUND Non-attendance results in administrative problems and disruption in patient care . Several interventions have been used to reduce non-attendance , with varying degree of success . A relatively new intervention , text messaging , has been shown to be as effective as telephone reminders in reducing non-attendance . However , no study has looked specifically at using text messaging reminders to reduce non-attendance in chronic disease care . AIM To determine if text messaging would be effective in reducing non-attendance in patients on long-term followup , compared with telephone reminders and no reminder . DESIGN OF STUDY A r and omised controlled trial with three arms : text messaging reminder , telephone reminder , and control . SETTING Two primary care clinics in Malaysia . METHOD A total of 931 subjects who had been on at least 6 months of follow-up were r and omised into the three groups . Demographic variables were recorded at the first visit . In the intervention arms , a reminder was sent 24–48 hours prior to the appointment . Non-attendance rate was documented at the second visit . Non-attenders were defined as those who did not attend , attended early , or attended late without rescheduling their appointment . Attenders were defined as participants who had turned up for their scheduled appointment and those who had changed or cancelled their appointment with notification . RESULTS The non-attendance rates in the text messaging group ( odds ratio [ OR ] = 0.62 , 95 % confidence interval [ CI ] = 0.41 to 0.93 , P = 0.020 ) and the telephone reminder group ( OR = 0.53 , 95 % CI = 0.35 to 0.81 ) , P = 0.003 ) were significantly lower than the control group . The absolute non-attendance rate for telephone reminders was lower by 2 % compared to the text messaging group . This difference was not found to be statistically significant ( P = 0.505 ) . CONCLUSION Text messaging was found to be as effective as telephone reminder in reducing non-attendance in patients who required long-term follow-up for their chronic illnesses in this study . It could be used as an alternative to conventional reminder systems",
"Background : Hypertension frequently accompanies diabetes mellitus , worsening prognosis and complicating medical care for patients . Low medication adherence with multiple medications is a major factor in the inadequate achievement of blood pressure treatment goals . Widespread access to mobile phones offers a new opportunity to communicate with patients and enhance disease self-management . Methods : We recruited 50 high-risk urban patients with hypertension , who are using at least two prescription medications for hypertension , into an open-label trial using medication reminder software on a mobile phone . Medication adherence was assessed by review of pharmacy refill rates before , during , and after availability of the medication reminder software ( pre-activation , activation , and post-activation phase , respectively ) . Results : Forty-eight patients completed the study . All subjects were insured by Medicaid , 96 % were African-American , and the majority had diabetes mellitus . The proportion of days covered for each study phase was as follows : Pre-activation phase = 0.54 , activation phase = 0.58 , and post-activation phase = 0.46 . A significant difference was found between the activation and post-activation phases ( p = .001 ) . The increase in measured adherence between the pre-activation and activation phases approached significance ( p = .057 ) . Forty-six patients completed the pre- and post-Morisky medication adherence survey . The median score rose from 2.0 at baseline to 3.0 at study completion ( p Average blood pressure and level of control during study period improved significantly after initiation of the study and remained improved from baseline through the course of the study . The 48 subjects who completed the study reported a high level of satisfaction with the medication reminder application at the final study visit . Conclusions : A mobile-phone-based automated medication reminder system shows promise in improving medication adherence and blood pressure in high-cardiovascular-risk individuals",
"Introduction Many studies have now demonstrated the efficacy of text messaging in positively changing behaviours . We aim ed to identify features and factors that explain the effectiveness of a successful text messaging program in terms of user engagement , perceived usefulness , behavior change and program delivery preferences . Methods Mixed methods qualitative design combining four data sources ; ( i ) analytic data extracted directly from the software system , ( ii ) participant survey , ( iii ) focus groups to identify barriers and enablers to implementation and mechanisms of effect and ( iv ) recruitment screening logs and text message responses to examine engagement . This evaluation was conducted within the TEXT ME trial — a parallel design , single-blind r and omized controlled trial ( RCT ) of 710 patients with coronary heart disease ( CHD ) . Qualitative data were interpreted using inductive thematic analysis . Results 307/352 ( 87 % response rate ) of recruited patients with CHD completed the program evaluation survey at six months and 25 participated in a focus group . Factors increasing engagement included ( i ) ability to save and share messages , ( ii ) having the support of providers and family , ( iii ) a feeling of support through participation in the program , ( iv ) the program being initiated close to the time of a cardiovascular event , ( v ) personalization of the messages , ( vi ) opportunity for initial face-to-face contact with a provider and ( vii ) that program and content was perceived to be from a credible source . Clear themes relating to program delivery were that diet and physical activity messages were most valued , four messages per week was ideal and most participants felt program duration should be provided for at least for six months or longer . Conclusions This study provides context and insight into the factors influencing consumer engagement with a text message program aim ed at improving health-related behavior . The study suggests program components that may enhance potential success but will require integration at the development stage to optimize up-scaling . Trial Registration Australia and New Zeal and Clinical Trials Registry , ACTRN12611000161921",
"Background Cardiac rehabilitation ( CR ) is a secondary prevention program that offers education and support to assist patients with coronary heart disease ( CHD ) make lifestyle changes . Despite the benefits of CR , attendance at centre-based sessions remains low . Mobile technology ( mHealth ) has potential to reach more patients by delivering CR directly to mobile phones , thus providing an alternative to centre-based CR . The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours ( for example , physically active , fruit and vegetable intake , not smoking , low alcohol consumption ) over and above usual CR services in New Zeal and adults diagnosed with CHD . Methods / design A two-arm , parallel , r and omised controlled trial will be conducted at two Auckl and hospitals in New Zeal and . One hundred twenty participants will be r and omised to receive a 24-week evidence - and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone ( control ) . The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months , measured using a composite health behaviour score . Secondary outcomes include overall cardiovascular disease risk , body composition , illness perceptions , self-efficacy , hospital anxiety/depression and medication adherence . Discussion This study is one of the first to examine an mHealth-delivered comprehensive CR program . Strengths of the trial include quality research design and in-depth description of the intervention to aid replication . If effective , the trial has potential to augment st and ard CR practice s and to be used as a model for other disease prevention or self-management programs . Trial registryAustralian New Zeal and Clinical Trials Registry :",
"Background There are well-documented treatment gaps in secondary prevention of coronary heart disease and no clear guidelines to assist early physical activity after acute coronary syndromes ( ACS ) . Smartphone technology may provide an innovative platform to close these gaps . This paper describes the study design of a r and omized controlled trial assessing whether a smartphone-based secondary prevention program can facilitate early physical activity and improve cardiovascular health in patients with ACS . Methods We have developed a multi-faceted , patient-centred smartphone-based secondary prevention program emphasizing early physical activity with a graduated walking program initiated on discharge from ACS admission . The program incorporates ; physical activity tracking through the smartphone ’s accelerometer with interactive feedback and goal setting ; a dynamic dashboard to review and optimize cardiovascular risk factors ; educational messages delivered twice weekly ; a photographic food diary ; pharmacotherapy review ; and support through a short message service . The primary endpoint of the trial is change in exercise capacity , as measured by the change in six-minute walk test distance at 8-weeks when compared to baseline . Secondary endpoints include improvements in cardiovascular risk factor status , psychological well-being and quality of life , medication adherence , uptake of cardiac rehabilitation and re-hospitalizations . Discussion This r and omized controlled trial will use a smartphone-phone based secondary prevention program to emphasize early physical activity post-ACS . It will provide evidence regarding the feasibility and utility of this innovative platform in closing the treatment gaps in secondary prevention . Trial registration The trial was retrospectively registered in the Australian New Zeal and Clinical Trials Registry ( ANZCTR ) on April 4 , 2016 . The registration number is ACTRN12616000426482",
"Background Mobile technology has the potential to deliver behavior change interventions ( mHealth ) to reduce coronary heart disease ( CHD ) at modest cost . Previous studies have focused on single behaviors ; however , cardiac rehabilitation ( CR ) , a component of CHD self-management , needs to address multiple risk factors . Objective The aim was to investigate the effectiveness of a mHealth-delivered comprehensive CR program ( Text4Heart ) to improve adherence to recommended lifestyle behaviors ( smoking cessation , physical activity , healthy diet , and nonharmful alcohol use ) in addition to usual care ( traditional CR ) . Methods A 2-arm , parallel , r and omized controlled trial was conducted in New Zeal and adults diagnosed with CHD . Participants were recruited in-hospital and were encouraged to attend center-based CR ( usual care control ) . In addition , the intervention group received a personalized 24-week mHealth program , framed in social cognitive theory , sent by fully automated daily short message service ( SMS ) text messages and a supporting website . The primary outcome was adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score ( ≥3 ) at 3 and 6 months . Secondary outcomes included clinical outcomes , medication adherence score , self-efficacy , illness perceptions , and anxiety and /or depression at 6 months . Baseline and 6-month follow-up assessment s ( unblinded ) were conducted in person . Results Eligible patients ( N=123 ) recruited from 2 large metropolitan hospitals were r and omized to the intervention ( n=61 ) or the control ( n=62 ) group . Participants were predominantly male ( 100/123 , 81.3 % ) , New Zeal and European ( 73/123 , 59.3 % ) , with a mean age of 59.5 ( SD 11.1 ) years . A significant treatment effect in favor of the intervention was observed for the primary outcome at 3 months ( AOR 2.55 , 95 % CI 1.12 - 5.84 ; P=.03 ) , but not at 6 months ( AOR 1.93 , 95 % CI 0.83 - 4.53 ; P=.13 ) . The intervention group reported significantly greater medication adherence score ( mean difference : 0.58 , 95 % CI 0.19 - 0.97 ; P=.004 ) . The majority of intervention participants reported reading all their text messages ( 52/61 , 85 % ) . The number of visits to the website per person ranged from zero to 100 ( median 3 ) over the 6-month intervention period . Conclusions A mHealth CR intervention plus usual care showed a positive effect on adherence to multiple lifestyle behavior changes at 3 months in New Zeal and adults with CHD compared to usual care alone . The effect was not sustained to the end of the 6-month intervention . A larger study is needed to determine the size of the effect in the longer term and whether the change in behavior reduces adverse cardiovascular events . Trial Registration ACTRN 12613000901707 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=364758&is Review = true ( Archived by WebCite at http://www.webcitation.org/6c4qhcHKt",
"Background Cardiac telerehabilitation has been introduced as an adjunct or alternative to conventional center-based cardiac rehabilitation to increase its long-term effectiveness . However , before large-scale implementation and reimbursement in current health care systems is possible , well- design ed studies on the effectiveness of this new additional treatment strategy are needed . Objective The aim of this trial was to assess the medium-term effectiveness of an Internet-based , comprehensive , and patient-tailored telerehabilitation program with short message service ( SMS ) texting support for cardiac patients . Methods This multicenter r and omized controlled trial consisted of 140 cardiac rehabilitation patients r and omized ( 1:1 ) to a 24-week telerehabilitation program in combination with conventional cardiac rehabilitation ( intervention group ; n=70 ) or to conventional cardiac rehabilitation alone ( control group ; n=70 ) . In the telerehabilitation program , initiated 6 weeks after the start of ambulatory rehabilitation , patients were stimulated to increase physical activity levels . Based on registered activity data , they received semiautomatic telecoaching via email and SMS text message encouraging them to gradually achieve predefined exercise training goals . Patient-specific dietary and /or smoking cessation advice was also provided as part of the telecoaching . The primary endpoint was peak aerobic capacity ( VO2 peak ) . Secondary endpoints included accelerometer-recorded daily step counts , self-assessed physical activities by International Physical Activity Question naire ( IPAQ ) , and health-related quality of life ( HRQL ) assessed by the HeartQol question naire at baseline and at 6 and 24 weeks . Results Mean VO2 peak increased significantly in intervention group patients ( n=69 ) from baseline ( mean 22.46 , SD 0.78 mL/[min*kg ] ) to 24 weeks ( mean 24.46 , SD 1.00 mL/[min*kg ] , P of aerobic capacity confirmed a significant difference between the intervention group and control group in favor of the intervention group ( P self-reported physical activity improved more in the intervention group compared to the control group ( P=.01 ) as did the global HRQL score ( P=.01 ) . Conclusions This study showed that an additional 6-month patient-specific , comprehensive telerehabilitation program can lead to a bigger improvement in both physical fitness ( VO2 peak ) and associated HRQL compared to center-based cardiac rehabilitation alone . These results are supportive in view of possible future implementation in st and ard cardiac care",
"IMPORTANCE Cardiovascular disease prevention , including lifestyle modification , is important but underutilized . Mobile health strategies could address this gap but lack evidence of therapeutic benefit . OBJECTIVE To examine the effect of a lifestyle-focused semipersonalized support program delivered by mobile phone text message on cardiovascular risk factors . DESIGN AND SETTING The Tobacco , Exercise and Diet Messages ( TEXT ME ) trial was a parallel-group , single-blind , r and omized clinical trial that recruited 710 patients ( mean age , 58 [ SD , 9.2 ] years ; 82 % men ; 53 % current smokers ) with proven coronary heart disease ( prior myocardial infa rct ion or proven angiographically ) between September 2011 and November 2013 from a large tertiary hospital in Sydney , Australia . INTERVENTIONS Patients in the intervention group ( n = 352 ) received 4 text messages per week for 6 months in addition to usual care . Text messages provided advice , motivational reminders , and support to change lifestyle behaviors . Patients in the control group ( n=358 ) received usual care . Messages for each participant were selected from a bank of messages according to baseline characteristics ( eg , smoking ) and delivered via an automated computerized message management system . The program was not interactive . MAIN OUTCOMES AND MEASURES The primary end point was low-density lipoprotein cholesterol ( LDL-C ) level at 6 months . Secondary end points included systolic blood pressure , body mass index ( BMI ) , physical activity , and smoking status . RESULTS At 6 months , levels of LDL-C were significantly lower in intervention participants , with concurrent reductions in systolic blood pressure and BMI , significant increases in physical activity , and a significant reduction in smoking . The majority reported the text messages to be useful ( 91 % ) , easy to underst and ( 97 % ) , and appropriate in frequency ( 86 % ) . [ table : see text ] . CONCLUSIONS AND RELEVANCE Among patients with coronary heart disease , the use of a lifestyle-focused text messaging service compared with usual care result ed in a modest improvement in LDL-C level and greater improvement in other cardiovascular disease risk factors . The duration of these effects and hence whether they result in improved clinical outcomes remain to be determined . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12611000161921",
"BACKGROUND The medical priority dispatch system ( MPDS ® ) assists lay rescuers in protocol -driven telephone-assisted cardiopulmonary resuscitation ( CPR ) . OBJECTIVE Our aim was to clarify which CPR instruction leads to sufficient compression depth . METHODS This was an investigator-blinded , r and omized , parallel group , simulation study to investigate 10 min of chest compressions after the instruction \" push down firmly 5 cm \" vs. \" push as hard as you can . \" Primary outcome was defined as compression depth . Secondary outcomes were participants exertion measured by Borg scale , provider 's systolic and diastolic blood pressure , and quality values measured by the skill-reporting program of the Resusci ( ® ) Anne Simulator manikin . For the analysis of the primary outcome , we used a linear r and om intercept model to allow for the repeated measurements with the intervention as a covariate . RESULTS Thirteen participants were allocated to control and intervention . One participant ( intervention ) dropped out after min 7 because of exhaustion . Primary outcome showed a mean compression depth of 44.1 mm , with an inter-individual st and ard deviation ( SDb ) of 13.0 mm and an intra-individual st and ard deviation ( SDw ) of 6.7 mm for the control group vs. 46.1 mm and a SDb of 9.0 mm and SDw of 10.3 mm for the intervention group ( difference : 1.9 ; 95 % confidence interval -6.9 to 10.8 ; p = 0.66 ) . Secondary outcomes showed no difference for exhaustion and CPR- quality values . CONCLUSIONS There is no difference in compression depth , quality of CPR , or physical strain on lay rescuers using the initial instruction \" push as hard as you can \" vs. the st and ard MPDS ( ® ) instruction \" push down firmly 5 cm .",
"BACKGROUND Although most cardiovascular disease occurs in low-income and middle-income countries , little is known about the use of effective secondary prevention medications in these communities . We aim ed to assess use of proven effective secondary preventive drugs ( antiplatelet drugs , β blockers , angiotensin-converting-enzyme [ ACE ] inhibitors or angiotensin-receptor blockers [ ARBs ] , and statins ) in individuals with a history of coronary heart disease or stroke . METHODS In the Prospect i ve Urban Rural Epidemiological ( PURE ) study , we recruited individuals aged 35 - 70 years from rural and urban communities in countries at various stages of economic development . We assessed rates of previous cardiovascular disease ( coronary heart disease or stroke ) and use of proven effective secondary preventive drugs and blood-pressure-lowering drugs with st and ardised question naires , which were completed by telephone interviews , household visits , or on patient 's presentation to clinics . We report estimates of drug use at national , community , and individual levels . FINDINGS We enrolled 153,996 adults from 628 urban and rural communities in countries with incomes classified as high ( three countries ) , upper-middle ( seven ) , lower-middle ( three ) , or low ( four ) between January , 2003 , and December , 2009 . 5650 participants had a self-reported coronary heart disease event ( median 5·0 years previously [ IQR 2·0 - 10·0 ] ) and 2292 had stroke ( 4·0 years previously [ 2·0 - 8·0 ] ) . Overall , few individuals with cardiovascular disease took antiplatelet drugs ( 25·3 % ) , β blockers ( 17·4 % ) , ACE inhibitors or ARBs ( 19·5 % ) , or statins ( 14·6 % ) . Use was highest in high-income countries ( antiplatelet drugs 62·0 % , β blockers 40·0 % , ACE inhibitors or ARBs 49·8 % , and statins 66·5 % ) , lowest in low-income countries ( 8·8 % , 9·7 % , 5·2 % , and 3·3 % , respectively ) , and decreased in line with reduction of country economic status ( p(trend) received no drugs in high-income countries ( 11·2 % ) , compared with 45·1 % in upper middle-income countries , 69·3 % in lower middle-income countries , and 80·2 % in low-income countries . Drug use was higher in urban than rural areas ( antiplatelet drugs 28·7 % urban vs 21·3 % rural , β blockers 23·5%vs 15·6 % , ACE inhibitors or ARBs 22·8%vs 15·5 % , and statins 19·9%vs 11·6 % ; all p affected rates of drug use more than did individual-level factors ( eg , age , sex , education , smoking status , body-mass index , and hypertension and diabetes statuses ) . INTERPRETATION Because use of secondary prevention medications is low worldwide-especially in low-income countries and rural areas - systematic approaches are needed to improve the long-term use of basic , inexpensive , and effective drugs . FUNDING Full funding sources listed at end of paper ( see Acknowledgments )",
"Background : Medication non-adherence leads to a vast range of negative outcomes in patients with coronary artery disease . An automated web-based system managing short message service ( SMS ) reminders is a telemedicine approach to optimise adherence among patients who frequently forget to take their medications or miss the timing . Aim : This paper sought to investigate the effect of automated SMS-based reminders on medication adherence in patients after hospital discharge following acute coronary syndrome ( ACS ) . Methods : An interventional study was conducted at a tertiary teaching hospital in Malaysia . A total of 62 patients with ACS were equally r and omised to receive either automated SMS reminders before every intake of cardiac medications or only usual care within eight weeks after discharge . The primary outcome was adherence to cardiac medications . Secondary outcomes were the heart functional status , and ACS-related hospital readmission and death rates . Results : There was a higher medication adherence level in the intervention group rather than the usual care group , ( χ2 (2)=18.614 , p of being low adherent among the control group was 4.09 times greater than the intervention group ( relative risk = 4.09 , 95 % confidence interval ( CI ) 1.82–9.18 ) . A meaningful difference was found in heart functional status between the two study groups with better results among patients who received SMS reminders , ( χ2 ( 1 ) = 16.957 , p automated SMS-based reminder system can potentially enhance medication adherence in ACS patients during the early post-discharge period",
"Background Mobile phone text message interventions are used to support behaviour change including physical activity , but we have less insight into how these interventions work and what factors predict response . Aims To study the effect of TEXT ME ( Tobacco EXercise and dieT Messages ) text message intervention on physical activity domains , consistency of effects across sub-groups and its additive value in patients that received traditional cardiac rehabilitation programme . Methods This is a secondary analysis of the TEXT ME , a r and omized clinical trial of lifestyle-focused text message intervention compared with usual care in patients with coronary heart disease . A quarter of the messages were design ed specifically to encourage physical activity . Sedentary time and physical activity were assessed using the Global Physical Activity Question naire . Results At baseline , 85 % of the 710 participants reported low physical activity levels . At six months , compared with controls , the intervention arm reported higher recreational physical activity ( 471 vs. 307 metabolic equivalent-min/week , p = 0.001 ) and travel physical activity ( 230 vs. 128 MET-min/week , p = 0.002 ) , similar work-related physical activity and lower sedentary times ( 494 vs. 587 min , p baseline physical activity , cardiac rehabilitation participation and text message intervention predicted physically active status at six months . Subjects that received both cardiac rehabilitation and text messaging intervention were more likely to achieve target physical activity levels compared with cardiac rehabilitation alone ( odds ratio 7.07 vs. 1.80 , p TEXT ME intervention improved recreational and travel physical activity , reduced sedentary times but had no effects on work-related physical activity . It had incremental benefits at achieving target physical activity levels even in patients participating in the traditional cardiac rehabilitation programme",
"BACKGROUND Patients undergoing cardiovascular procedures remain at increased risk for myocardial infa rct ion , stroke , and cardiovascular death . Risk factor control in this patient population remains suboptimal and would likely benefit from strategies targeting education , lifestyle , and healthy behaviors . DESIGN The IMPACT trial is a 400-subject prospect i ve r and omized trial design ed to compare different cardiovascular prevention strategies in subjects following a cardiovascular intervention . The trial began enrollment in the Spring of 2012 and is r and omizing subjects in a 1:1:1 manner to usual care , a one-time cardiovascular prevention consult , or a one-time cardiovascular prevention consult plus behavioral intervention program ( telephone-based motivational interviewing and tailored text messages ) over a 6-month period . The primary end point is non-high-density lipoprotein cholesterol . Secondary end points include other plasma lipid values , metabolic risk , smoking cessation , physical activity , dietary intake , medication use and adherence , and quality of life . CONCLUSIONS The IMPACT trial provides data on different management strategies for risk factor optimization in subjects following cardiovascular procedures . The results will provide a platform for the continued development of novel multidisciplinary interventions in this high-risk population",
"Background : Self-care management has recently been suggested as an effective approach for secondary prevention of hypertension . This study was conducted to examine whether self-care behaviors could modulate blood pressure levels and also comparing the different training methods of self-care on patients ' adherence and controlling hypertension . Material s and Methods : This study was a prospect i ve r and omized controlled clinical trial , conducted on 180 hypertensive patients referring to four centers in Isfahan , Iran , between July and December 2013 . Block r and omization method were applied to divide eligible subjects into four equal groups , including group A in which the patients and their family were educated by cardiology resident about self-care behaviors through eight sessions , group B and group C were obtained self-care education through four pamphlets or eight short message services ( SMS ) , respectively and group D were obtained only usual care of hypertension without any training about self-care management . Results : Increasing vegetable intake and frequency of subject who took antihypertensive medication regularly and the reduction in the frequency of subjects who consumed high salt were significantly more in group A than the others ( P = 0.001 , P respectively ) . The systolic and diastolic blood pressure had significantly more reduction in the group A than the other groups ( −8.18 ± 18.3 and − 3.89 ± 4.1 ; P The self-care management education integration into the usual care along with using SMS and other educational material s may improve the efficient and effective adherence strategies ",
"AIMS The rapidly increasing prevalence of chronic diseases is an important challenge to healthcare systems worldwide . To improve the quality and efficiency of chronic disease care , we investigated the effectiveness and applicability of the Ubiquitous Chronic Disease Care ( UCDC ) system using cellular phones and the internet for overweight patients with both Type 2 diabetes and hypertension . METHODS We conducted a r and omized , controlled clinical trial over 3 months that included 123 patients at a university hospital and a community public health centre . RESULTS After 12 weeks , there were significant improvements in HbA(1c ) in the intervention group ( 7.6 + /- 0.9 % to 7.1 + /- 0.8 % , P systolic and diastolic blood pressure , as well as improvements in total cholesterol , low-density lipoprotein-cholesterol and triglyceride levels in the intervention group . Furthermore , there was a significant increase in adiponectin levels in the intervention group compared with the control group , although high-sensitivity C-reactive protein and interleukin-6 levels did not change in either group . CONCLUSIONS The novel UCDC system presented in this paper improved multiple metabolic parameters simultaneously in overweight patients with both Type 2 diabetes and hypertension",
"Background : Cardiac self-efficacy is an essential factor in persistence of healthy behaviors in patients with coronary artery disease ( CAD ) . Today , telenursing methods have numerous applications in health care . Therefore , this study aim ed to determine the effect of a text message and telephone follow-up program on cardiac self-efficacy of patients with CAD . Material s and Methods : This was a r and omized controlled trial on 70 patients with CAD who were hospitalized in Shahid Chamran Hospital ( Isfahan , Iran ) . The participants were r and omly assigned to the experimental and control groups . Collection of data on cardiac self-efficacy was performed before , 3 months after , and 4 months after the beginning of the intervention using Cardiac Self-Efficacy Scale design ed by Sullivan et al. During the 3 months of intervention , six messages were sent to the subjects each week and calls were made twice a week in the first month and once a week during the second and third months . The statistical analysis of data was performed using independent t-test , Chi-square , Mann-Whitney U test , and repeated measures analysis of variance ( ANOVA ) . Results : Before the intervention , there was no significant difference between the mean scores of cardiac self-efficacy of the two groups . However , 3 months and 4 months after the beginning of the intervention , the mean score of cardiac self-efficacy in the experimental group was significantly higher than in the control group ( P text message and telephone follow-up program is effective in promoting the cardiac self-efficacy of patients with CAD",
"Rationale Stroke is the second-leading cause of death in low- and middle-income countries , but use of evidence -based therapies for stroke prevention in such countries , especially those in Africa , is extremely poor . This study is design ed to enhance the implementation and sustainability of secondary stroke-preventive services following hospital discharge . Aim /Hypothesis The primary study aim is to test whether a Chronic Care Model-based initiative entitled the Tailored Hospital-based Risk reduction to Impede Vascular Events after Stroke ( THRIVES ) significantly improves blood pressure control after stroke . Design This prospect i ve triple-blind r and omized controlled trial will include a cohort of 400 patients with a recent stroke discharged from four medical care facilities in Nigeria . The culturally sensitive , system-appropriate intervention comprises patient report cards , phone text messaging , an educational video , and coordination of posthospitalization care . Study Outcomes The primary outcome is improvement of blood pressure control . Secondary endpoints include control of other stroke risk factors , medication adherence , functional status , and quality of life . We will also perform a cost analysis of THRIVES from the viewpoint of government policy-makers . Discussion We anticipate that a successful intervention will serve as a scalable model of effective postdischarge chronic blood pressure management for stroke in sub-Saharan Africa and possibly for other symptomatic cardiovascular disease entities in the region",
"Background Mobile health ( mHealth ) interventions may improve heart failure ( HF ) self-care , but st and ard models do not address informal caregivers ’ needs for information about the patient ’s status or how the caregiver can help . Objective We evaluated mHealth support for caregivers of HF patients over and above the impact of a st and ard mHealth approach . Methods We identified 331 HF patients from Department of Veterans Affairs outpatient clinics . All patients identified a “ CarePartner ” outside their household . Patients r and omized to “ st and ard mHealth ” ( n=165 ) received 12 months of weekly interactive voice response ( IVR ) calls including questions about their health and self-management . Based on patients ’ responses , they received tailored self-management advice , and their clinical team received structured fax alerts regarding serious health concerns . Patients r and omized to “ mHealth+CP ” ( n=166 ) received an identical intervention , but with automated emails sent to their CarePartner after each IVR call , including feedback about the patient ’s status and suggestions for how the CarePartner could support disease care . Self-care and symptoms were measured via 6- and 12-month telephone surveys with a research associate . Self-care and symptom data also were collected through the weekly IVR assessment s. Results Participants were on average 67.8 years of age , 99 % were male ( 329/331 ) , 77 % where white ( 255/331 ) , and 59 % were married ( 195/331 ) . During 15,709 call-weeks of attempted IVR assessment s , patients completed 90 % of their calls with no difference in completion rates between arms . At both endpoints , composite quality of life scores were similar across arms . However , more mHealth+CP patients reported taking medications as prescribed at 6 months ( 8.8 % more , 95 % CI 1.2 - 16.5 , P=.02 ) and 12 months ( 13.8 % more , CI 3.7 - 23.8 , P mHealth+CP patients reported talking with their CarePartner at least twice per week at the 6-month follow-up ( P=.048 ) . mHealth+CP patients were less likely to report negative emotions during those interactions at both endpoints ( both P taking medications as prescribed during weekly IVR assessment s , and also were less likely to report breathing problems or weight gains ( all P patients with more depressive symptoms at enrollment , those r and omized to mHealth+CP were more likely than st and ard mHealth patients to report excellent or very good general health during weekly IVR calls . Conclusions Compared to a relatively intensive model of IVR monitoring , self-management assistance , and clinician alerts , a model including automated feedback to an informal caregiver outside the household improved HF patients ’ medication adherence and caregiver communication . mHealth+CP may also decrease patients ’ risk of HF exacerbations related to shortness of breath and sudden weight gains . mHealth+CP may improve quality of life among patients with greater depressive symptoms . Weekly health and self-care monitoring via mHealth tools may identify intervention effects in mHealth trials that go undetected using typical , infrequent retrospective surveys . Trial Registration Clinical Trials.gov NCT00555360 ; https:// clinical trials.gov/ct2/show/NCT00555360 ( Archived by WebCite at http://www.webcitation.org/6Z4Tsk78B )",
"Antihypertensive drug adherence ( ADA ) is a mainstay in blood pressure control . Education through mobile phone short message system ( SMS ) text messaging could improve ADA . The authors conducted a r and omized study involving 314 patients with hypertension with Patients were r and omly assigned to receive or not receive SMS related to ADA and healthy lifestyle . Adherence was assessed by the self-reported four-item scale Morisky-Green-Levine question naire at baseline and after 6 months of follow-up , with four of four positive questions classified as good adherence . Group comparison for adherence was performed by means of a logistic regression model , adjusting by baseline adherence , age older than 60 years , and sex . A total of 163 patients were r and omized to receive and 151 to not receive SMS . After 6 months of follow-up , ADA in the non-SMS group decreased from 59.3 % to 51.4 % ( P=.1 ) . By contrast , adherence increased from 49 % to 62.3 % ( P=.01 ) in the SMS group . Text messaging intervention improved ADA ( risk ratio , 1.3 ; 95 % confidence interval , 1.0 - 1.6 [ P text messaging result ed in an increase in reporting ADA in this hypertensive Latino population . This approach could become an effective tool to overcome poor medication adherence in the community",
"An Internet-based store- and -retrieval telemedicine system to communicate between patients and their healthcare provider was tested . The system requires no specialized equipment , is Web-based , and allows frequent surveillance of the health status of the patients with heart failure ( HF ) . Thirty six patients were recruited to evaluate a Web-based telemedicine system for reducing care encounters . Eighteen patients were r and omized to the telemedicine arm ( group T ) , and 18 were given usual clinical care ( group C ) in our HF center . Patients in group T reported three times weekly via a secure Internet site for telemedicine intervention . We studied patients with HF with New York Heart Association ( NYHA ) class 2 to 4 with hospitalization within past 6 months . Mean age was 56.1 + /- 12.6 years ( 66.7 % male ; 66.7 % Caucasian , 27.8 % African American , and 5.6 % Hispanic ) . Mean ejection fraction ( EF ) was 23.9 % + /- 17.6 % in group T and 26.6 % + /- 16.4 % in group C. Over an 8-month period , unscheduled ( group T-3 ; group C-5 ) , and scheduled clinic visits ( group T-11 , group C-7 ) were similar ( p = NS ) ; one group T patient was transplanted , one group C patient died . Total hospital days were lower with group T ( 44 days ) compared to group C ( 133 days ) , p telemedicine system was able to closely monitor patients with HF . Surveillance through Internet-based telemedicine result ed in less hospitalization compared to control patients . This system may be helpful in reducing the cost of HF patient care",
"Background An increase in physical activity for secondary prevention of cardiovascular disease and cardiac rehabilitation has multiple therapeutic benefits , including decreased mortality . Internet- and mobile-based interventions for physical activity have shown promising results in helping users increase or maintain their level of physical activity in general and specifically in secondary prevention of cardiovascular diseases and cardiac rehabilitation . One component related to the efficacy of these interventions is tailoring of the content to the individual . Objective Our trial assessed the effect of a longitudinally tailored Internet- and mobile-based intervention for physical activity as an extension of a face-to-face cardiac rehabilitation stay . We hypothesized that users of the tailored intervention would maintain their physical activity level better than users of the nontailored version . Methods The study population included adult participants of a cardiac rehabilitation program in Norway with home Internet access and a mobile phone . The participants were r and omized in monthly clusters to a tailored or nontailored ( control ) intervention group . All participants had access to a website with information regarding cardiac rehabilitation , an online discussion forum , and an online activity calendar . Those using the tailored intervention received tailored content based on models of health behavior via the website and mobile fully automated text messages . The main outcome was self-reported level of physical activity , which was obtained using an online international physical activity question naire at baseline , at discharge , and at 1 month and 3 months after discharge from the cardiac rehabilitation program . Results Included in the study were 69 participants . One month after discharge , the tailored intervention group ( n=10 ) had a higher median level of overall physical activity ( median 2737.5 , IQR 4200.2 ) than the control group ( n=14 , median 1650.0 , IQR 2443.5 ) , but the difference was not significant ( Kolmogorov-Smirnov Z=0.823 , P=.38 , r=.17 ) . At 3 months after discharge , the tailored intervention group ( n=7 ) had a significantly higher median level of overall physical activity ( median 5613.0 , IQR 2828.0 ) than the control group ( n=12 , median 1356.0 , IQR 2937.0 ; Kolmogorov-Smirnov Z=1.397 , P=.02 , r=.33 ) . The median adherence was 45.0 ( 95 % CI 0.0 - 169.8 ) days for the tailored group and 111.0 ( 95 % CI 45.1 - 176.9 ) days for the control group ; however , the difference was not significant ( P=.39 ) . There were no statistically significant differences between the 2 groups in stage of change , self-efficacy , social support , perceived tailoring , anxiety , or depression . Conclusions Because of the small sample size and the high attrition rate at the follow-up visits , we can not make conclusions regarding the efficacy of our approach , but the results indicate that the tailored version of the intervention may have contributed to the long-term higher physical activity maintained after cardiac rehabilitation by participants receiving the tailored intervention compared with those receiving the nontailored intervention . Trial Registration Clinical Trials.gov : NCT01223170 ; http:// clinical trials.gov/show/NCT01223170 ( Archived by WebCite at http://www.webcitation.org/6Nch4ldcL )",
"OBJECTIVE Pharmacologic treatment for secondary prevention of coronary heart disease ( CHD ) is critical to prevent adverse clinical outcomes . In a r and omized controlled trial , we compared antiplatelet and statin adherence among patients with CHD who received : ( 1 ) text messages ( TM ) for medication reminders and education , ( 2 ) educational TM only , or ( 3 ) No TM . METHODS A mobile health intervention delivered customized TM for 30 days . We assessed and analyzed medication adherence with electronic monitoring devices [ Medication Event Monitoring System ( MEMS ) ] by one-way ANOVA and Welch tests , two-way TM response rates by t-tests , and self-reported adherence ( Morisky Medication Adherence Scale ) by Repeated Measures ANOVA . RESULTS Among 90 patients ( 76 % male , mean age 59.2 years ) , MEMS revealed patients who received TM for antiplatelets had a higher percentage of correct doses taken ( p=0.02 ) , percentage number of doses taken ( p=0.01 ) , and percentage of prescribed doses taken on schedule ( p=0.01 ) . TM response rates were higher for antiplatelets than statins ( p=0.005 ) . Self-reported adherence revealed no significant differences among groups . CONCLUSION TM increased adherence to antiplatelet therapy demonstrated by MEMS and TM responses . PRACTICE IMPLICATION S Feasibility and high satisfaction were established . Mobile health interventions show promise in promoting medication adherence",
"Background About one third of patients prescribed blood pressure or lipid-lowering drugs for the prevention of coronary heart disease and stroke do not take their medication as prescribed . We conducted a r and omized trial to evaluate text messaging as a means of improving adherence to cardiovascular disease preventive treatment . Methods 303 patients taking blood pressure and /or lipid-lowering medications were r and omly assigned to being sent text messages ( Text group , 151 ) or not being sent them ( No text group , 152 ) . Texts were sent daily for 2 weeks , alternate days for 2 weeks and weekly thereafter for 22 weeks ( 6 months overall ) , using an automated computer programme . Patients were asked to respond on whether they had taken their medication , whether the text reminded them to do so if they had forgotten , and if they had not taken their medication to determine if there was a reason for not doing so . At 6 months , use of medication was assessed . Results Two patients were lost to follow-up , providing data on 301 for analysis . In the No text group 38/151 ( 25 % ) took less than 80 % of the prescribed regimen ( ie . stopped medication completely or took it on fewer than 22 of the last 28 days of follow-up ) compared to 14/150 patients ( 9 % ) in the Text group – an improvement in adherence affecting 16 per 100 patients ( 95 % CI 7 to 24 ) , p take medication on at least one occasion and lead to 20/151 ( 13 % ) who stopped taking medication because of concern over efficacy or side-effects , resuming treatment . Conclusions In patients taking blood pressure or lipid-lowering treatment for the prevention of cardiovascular disease , text messaging improved medication adherence compared with no text messaging . Trial Registration Controlled-Trials.com IS RCT",
"BACKGROUND : Mobile technologies ( mHealth ) have recently been used to deliver behavior change interventions ; however , few have investigated the application of mHealth for treatment of ischemic heart disease ( IHD ) . The Heart Exercise And Remote Technologies trial examined the effectiveness of an mHealth intervention to increase exercise behavior in adults with IHD . As a part of this trial , a process evaluation was conducted . METHODS : One hundred seventy-one adults with IHD were r and omized to receive a 6-month mHealth intervention ( n = 85 ) plus usual care or usual care alone ( n = 86 ) . The intervention delivered a theory-based , automated package of exercise prescription and behavior change text messages and a supporting Web site . Three sources of data were triangulated to assess intervention participant perceptions : ( 1 ) Web site usage statistics ; ( 2 ) feedback surveys ; and ( 3 ) semistructured exit interviews . Descriptive information from survey and Web data were merged with qualitative data and analyzed using a semantic thematic approach . RESULTS : At 24 weeks , all intervention participants provided Web usage statistics , 75 completed the feedback survey , and 17 were interviewed . Participants reported reading the text messages ( 70/75 ; 93 % ) and liked the content ( 55/75 ; 73 % ) . The program motivated participants to exercise . Several suggestions to improve the program included further tailoring of the content ( 7/75 ; 7 % ) and increased personal contact ( 10/75 ; 13 % ) . CONCLUSIONS : Adults with IHD were able to use an mHealth program and reported that text messaging is a good way to deliver exercise information . While mHealth is design ed to be automated , programs might be improved if content and delivery were tailored to individual needs",
"Background Hypertension ( HTN ) is a major public health concern in the United States , with almost 78 million Americans age 20 years and over suffering from the condition . Moreover , HTN is a key risk factor for health disease and stroke . African Americans disproportionately shoulder the burdens of HTN , with greater prevalence , disease severity , earlier onset , and more HTN-related complications than age-matched whites . Medication adherence for the treatment of HTN is poor , with estimates indicating that only about half of hypertensive patients are adherent to prescribed medication regimens . Although no single intervention for improving medication adherence has emerged as superior to others , text message medication reminders have the potential to help improve medication adherence in African Americans with uncontrolled HTN as mobile phone adoption is very high in this population . Objective The purpose of this two-phased study was to develop ( Phase I ) and test in a r and omized controlled trial ( RCT ) ( Phase II ) a text message system , BPMED , to improve the quality of medication management through increasing medication adherence in African Americans with uncontrolled HTN . Methods In Phase I , we recruited 16 target end-users from a primary care clinic , to assist in the development of BPMED through participating in one of three focus groups . Focus groups sought to gain patient perspectives on HTN , medication adherence , mobile phone use , and the use of text messaging to support medication adherence . Potential intervention design s were presented to participants , and feedback on the design s was solicited . In Phase II , we conducted two pilot RCTs to determine the feasibility , acceptability , and preliminary efficacy of BPMED in primary care and emergency department setting s. Both pilot studies recruited approximately 60 participants , who were r and omized equally between usual care and the BPMED intervention . Results Although data collection is now complete , data analysis from the two pilot RCTs is still ongoing and results are expected in 2015 . Conclusions This study was design ed to determine preliminary feasibility and acceptability of our approach among African Americans with uncontrolled HTN in primary care and emergency department setting s. Results from these studies are of great interest as little work has been done to document the use of text message medication reminders to improve HTN-related outcomes , particularly within underserved urban minorities . Trial Registration Clinical trials.gov NCT01465217 ; https:// clinical trials.gov/ct2/show/NCT01465217 ( Archived by WebCite at http://www.webcitation.org/6V0tto0lZ )",
"PURPOSE : Efficient ways are needed to implement the secondary prevention ( SP ) of coronary heart disease . Because few studies have investigated Web-based SP programs , our aim was to determine the usefulness of a new Web-based telemonitoring system , connecting patients provided with self-measurement devices and care managers via mobile phone text messages , as a tool for SP . METHODS : A single-blind , r and omized controlled , clinical trial of 203 acute coronary syndrome ( ACS ) survivors , was conducted at a hospital in Madrid , Spain . All patients received lifestyle counseling and usual-care treatment . Patients in the telemonitoring group ( TMG ) sent , through mobile phones , weight , heart rate , and blood pressure ( BP ) weekly , and capillary plasma lipid profile and glucose monthly . A cardiologist accessed these data through a Web interface and sent recommendations via short message service . Main outcome measures were BP , body mass index ( BMI ) , smoking status , low-density lipoprotein-cholesterol ( LDL-c ) , and glycated hemoglobin A1c ( HbA1c ) . RESULTS : At 12-month followup , TMG patients were more likely ( RR = 1.4 ; 95 % CI = 1.1−1.7 ) to experience improvement in cardiovascular risk factors profile than control patients ( 69.6 % vs 50.5 % , P = .010 ) . More TMG patients achieved treatment goals for BP ( 62.1 % vs 42.9 % , P = .012 ) and HbA1c ( 86.4 % vs 54.2 % , P = .018 ) , with no differences in smoking cessation or LDL-c . Body mass index was significantly lower in TMG ( −0.77 kg/m2 vs + 0.29 kg/m2 , P = .005 ) . CONCLUSIONS : A telemonitoring program , via mobile phone messages , appears to be useful for improving the risk profile in ACS survivors and can be an effective tool for secondary prevention , especially for overweight patients",
"We conducted a feasibility study of a telehealth intervention ( an electronic pill box ) and an m-health intervention ( an app on a smartphone ) for improving medication adherence in older adults with heart failure . A secondary aim was to compare patient acceptance of the devices . The participants were 60 adults with HF ( 65 % male ) . Their average age was 69 years and 83 % were Caucasian . Patients were r and omized using a 2 × 2 design to one of four groups : pillbox silent , pillbox reminding , smartphone silent , smartphone reminding . We examined adherence to 4 medications over 28 days . The overall adherence rate was 78 % ( SD 35 ) . People with the telehealth device adhered 80 % of the time and people with the smartphone adhered 76 % of the time . Those who received reminders adhered 79 % of the time , and those with passive medication reminder devices adhered 78 % of the time , i.e. reminding did not improve adherence . Patients preferred the m-health approach . Future interventions may need to address other contributors to poor adherence such as motivation",
"Objective : Medication adherence is a complex behavior that is influenced by numerous factors . Applying self-efficacy theory , the primary aim of this r and omized controlled trial was to compare medication self-efficacy among patients with coronary heart disease who received : ( a ) text messages ( TMs ) for medication reminders and education , ( b ) TMs for education , or ( c ) no TMs . The second aim was to identify the personal ( sociodemographic and clinical characteristics ) and psychosocial factors that were associated with and predicted medication adherence . Methods : Customized TMs were delivered over 30 days . Repeated measures analysis of variance was used to analyze medication self-efficacy . A multiple regression analysis was performed at baseline and follow-up to determine variables that were associated with and predicted self-reported medication adherence . Results : Among 90 subjects with mean age 59.2 years ( st and ard deviation ( SD ) 9.4 , range 35–83 ) , total scores for medication self-efficacy improved over 30 days ; however , there was no significant difference in this improvement as a function of the different treatment groups ( p=0.64 ) . Controlling for other variables in the model ( age , education , depression , and social support ) , less depression ( p=0.004 ) and higher social support ( p=0.02 ) positively predicted higher medication adherence in the final model . Conclusions : TM medication reminders and /or health education did not improve medication self-efficacy . Further theory testing of current and future models and interventions are required to underst and variables related to self-efficacy and medication adherence . Addressing psychosocial factors such as depression and social support should be a priority to improve medication adherence among patients with coronary heart disease"
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Background : The short-term benefits of aerobic and resistance exercise in subjects affected by Peripheral Arterial Disease ( PAD ) are scarcely examined in interaction . This study aim ed to identify the effects of combined aerobic and resistance exercise programs on walking performance compared with isolated aerobic exercise or with the usual care in patients with intermittent claudication . Methods : A systematic review was conducted following the PRISMA statement . A total of five electronic data bases were search ed ( until October 2019 ) for r and omized and non-r and omized controlled trials . The focus comprised PAD patients with intermittent claudication who performed a combined aerobic and resistance exercise program that assessed the walking performance . Results : Seven studies include combined aerobic and resistance exercise vs. isolated aerobic or vs. usual care . The studies represented a sample size of 337 participants . The follow-up ranged from 4 to 12 weeks , 2 to 5 times-per-week . The risk of bias in the trials was a deemed moderate-to-high risk . After the interventions , the percent change in walking performance outcomes had a large variation . In the combined and isolated aerobic programs , the walking performance always improved , while in the usual care group oscillates between the deterioration and the improvement in all outcomes . Combined exercise and isolated aerobic exercise improved the claudication onset distance from 11 to 396 % , and 30 to 422 % , the absolute claudication distance from 81 to 197 % , and 53 to 121 % , and the maximal walking distance around 23 and 10 % , respectively . Conclusions : Currently , there is insufficient evidence about the effects of combined aerobic and resistance exercise compared to isolated aerobic exercise or usual care on walking performance . However , despite the low quality of evidence , the combined aerobic and resistance exercise seems to be an effective strategy to improve walking performance in patients with intermittent claudication . These combined exercise modes or isolated aerobic exercise produce positive and significant results on walking performance . The usual care approach has a trend to deteriorate the walking performance . Thus , given the scarcity of data , new r and omized controlled trial studies that include assessment s of cardiovascular risk factors are urgently required to better determine the effect of this exercise combination
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"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",
"We employed near-infrared optical techniques , diffuse correlation spectroscopy ( DCS ) , and frequency-domain near-infrared spectroscopy ( FD-NIRS ) to test the hypothesis that supervised exercise training increases skeletal muscle microvascular blood flow and oxygen extraction in patients with peripheral artery disease ( PAD ) who experience claudication . PAD patients ( n = 64 ) were r and omly assigned to exercise and control groups . Patients in the exercise group received 3 mo of supervised exercise training . Calf muscle blood flow and oxygen extraction were optically monitored before , during , and after performance of a grade d treadmill protocol at baseline and at 3 mo in both groups . Additionally , measurements of the ankle-brachial index ( ABI ) and peak walking time ( PWT ) to maximal claudication were made during each patient visit . Supervised exercise training was found to increase the maximal calf muscle blood flow and oxygen extraction levels during treadmill exercise by 29 % ( 13 % , 50 % ) and 8 % ( 1 % , 12 % ) , respectively [ P Exercise training also increased PWT by 49 % ( 18 % , 101 % ) ( P = 0.01 ) . However , within statistical error , the ABI , resting calf muscle blood flow and oxygen extraction , and the recovery half-time for hemoglobin\\myoglobin desaturation following cessation of maximal exercise were not altered by exercise training . The concurrent monitoring of both blood flow and oxygen extraction with the hybrid DCS/FD-NIRS instrument revealed enhanced muscle oxidative metabolism during physical activity from exercise training , which could be an underlying mechanism for the observed improvement in PWT . NEW & NOTEWORTHY We report on noninvasive optical measurements of skeletal muscle blood flow and oxygen extraction dynamics before/during/after treadmill exercise in peripheral artery disease patients who experience claudication . The measurements tracked the effects of a 3-mo supervised exercise training protocol and revealed that supervised exercise training improved patient ability to increase microvascular calf muscle blood flow and oxygen extraction during physical activity",
"Objective : Cardiopulmonary resuscitation ( CPR ) is a series of lifesaving actions that improve the chance of survival following cardiac arrest ( CA ) . Many clinical and laboratory parameters , such as the presence of asystole , out-of-hospital CPR , and duration of cardiac arrest , are associated with failed CPR in patients with CA . Asystole is a state of no cardiac electrical activity , along with the absence of contractions of the myocardium and absence of cardiac output . Oxidative stress index ( OSI ) , which is the ratio of total oxidative status to total antioxidant status , increases by ischemia-reperfusion injury . We investigated whether OSI levels in patients with CA could predict early mortality after CPR . Methods : This study has a prospect i ve observational cohort design . Five patients with a history of cancer , four patients who developed hemolysis in their blood , six patients who were transferred to our hospital from other hospitals , and six patients in whom blood sample s for OSI could not be stored properly were excluded . Finally , a total of 90 in-hospital or out-of-hospital CA patients and 40 age- and sex-matched healthy volunteers as the control group were evaluated prospect ively . The patients were classified according to the CPR response into a successful group ( n=46 ) and a failed group ( n=44 ) . Comparisons between groups were performed using one-way ANOVA with post hoc analysis by Tukey ’s HSD or independent sample s t-test and the Kruskal-Wallis tests or Mann-Whitney U test for normally and abnormally distributed data , respectively . Also , we used chi-square test , Spearman ’s correlation test , univariate and multible logistic regression analyses , and receiver operator characteristic curve analysis . Results : OSI was 3.0±4.0 , 5.6±4.3 , and 8.7±3.8 in the control group , the successful CPR group , and the failed CPR group , respectively ( p OSI on admission , ischemia-modified albumin , presence of asystole , mean duration of cardiac arrest , out-of-hospital CPR , pH , and potassium and sodium levels were found to have prognostic significance in the univariate analysis . In the multivariate logistic regression model , OSI on admission ( OR=1.325 , p=0.003 ) , ischemia-modified albumin ( OR=1.008 , p=0.005 ) , presence of asystole ( OR=13.576 , p early mortality . In addition , the optimal cut-off value of OSI to predict post-CPR mortality was measured as > 6.02 , with 84.1 % sensitivity and 76.1 % specificity . Conclusion : Elevated OSI levels can predict failed CPR in CA patients",
"Background This prospect i ve , r and omized , controlled clinical trial compared changes in primary outcome measures of claudication onset time ( COT ) and peak walking time ( PWT ) , and secondary outcomes of submaximal exercise performance , daily ambulatory activity , vascular function , inflammation , and calf muscle hemoglobin oxygen saturation ( StO2 ) in patients with symptomatic peripheral artery disease ( PAD ) following new exercise training using a step watch ( NEXT Step ) home‐exercise program , a supervised exercise program , and an attention‐control group . Methods and Results One hundred eighty patients were r and omized . The NEXT Step program and the supervised exercise program consisted of intermittent walking to mild‐to‐moderate claudication pain for 12 weeks , whereas the controls performed light resistance training . Change scores for COT ( P PWT ( P 6‐minute walk distance ( P=0.028 ) , daily average cadence ( P=0.011 ) , time to minimum calf muscle StO2 during exercise ( P=0.025 ) , large‐artery elasticity index ( LAEI ) ( P=0.012 ) , and high‐sensitivity C‐reactive protein ( hsCRP ) ( P=0.041 ) were significantly different among the 3 groups . Both the NEXT Step home program and the supervised exercise program demonstrated a significant increase from baseline in COT , PWT , 6‐minute walk distance , daily average cadence , and time to minimum calf StO2 . Only the NEXT Step home group had improvements from baseline in LAEI , and hsCRP ( P . Conclusions NEXT Step home exercise utilizing minimal staff supervision has low attrition , high adherence , and is efficacious in improving COT and PWT , as well as secondary outcomes of submaximal exercise performance , daily ambulatory activity , vascular function , inflammation , and calf muscle StO2 in symptomatic patients with PAD . Clinical Trial Registration URL : Clinical Trials.gov . Unique Identifier : NCT00618670",
"OBJECTIVES Supervised exercise training ( SET ) is recommended for patients with intermittent claudication ( IC ) . The optimal exercise programme has not been identified , and the potential adverse effects of exercise on these patients warrant consideration . Calpain proteases have been linked with tissue atrophy following ischaemia-reperfusion injury . High calpain activity may therefore cause muscle wasting in claudicants undergoing SET , and skeletal muscle mass ( SMM ) is integral to healthy ageing . This study assesses the impact of ( 1 ) treadmill-based SET alone ; and ( 2 ) treadmill-based SET combined with resistance training on pain-free walking distance ( PFWD ) , SMM , and calpain activity . METHODS Thirty-five patients with IC were r and omised to 12 weeks of treadmill only SET ( group A ) , or combined treadmill and lower-limb resistance SET ( group B ) . PFWD via a 6-minute walking test , SMM via dual energy X-ray absorptiometry , and calpain activity via biopsies of gastrocnemius muscles were analysed . RESULTS Intention-to-treat analyses revealed PFWD improved within group A ( 160 m to 204 m , p = .03 ) , but not group B ( 181 m to 188 m , p = .82 ) . There was no between group difference ( p = .42 ) . Calpain activity increased within group A ( 1.62 × 10(5 ) fluorescent units [ FU ] to 2.21 × 10(5 ) FU , p = .05 ) , but not group B. There was no between group difference ( p = .09 ) . SMM decreased within group A ( -250 g , p = .11 ) and increased in group B ( 210 g , p = .38 ) ( p = .10 between groups ) . Similar trends were evident for per protocol analyses , but , additionally , change in SMM was significantly different between groups ( p = .04 ) . CONCLUSIONS Neither exercise regimen was superior in terms of walking performance . Further work is required to investigate the impact of the calpain system on SMM in claudicants undertaking SET ",
"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",
"Objective : The aim of this study was to evaluate the effectiveness of a supervised exercise program ( SEP ) plus at home nonsupervised exercise therapy ( non-SET ) on functional status , quality of life ( QoL ) and hemodynamic response in post-lower-limb bypass surgery patients . Results : One hundred and seventeen patients were r and omized to an intervention ( n = 57 ) or a control group ( n = 60 ) . A new individual SEP was design ed for patients with peripheral arterial disease ( PAD ) and applied to the studied subjects of the intervention group who also continued non-SET at home , whereas those assigned to the control group received just usual SEP according to a common cardiovascular program . The participants of the study were assessed by a 6-min walking test ( 6 MWT ) , an ankle-brachial index ( ABI ) , and the Medical Outcomes Study Short Form-36 ( SF-36 ) of QoL at baseline , at 1 and 6 months after surgery . A significant improvement was observed in the walked distance in the intervention group after 6 months compared with the control group ( p higher QoL score in the physical and mental component of SF-36 ( p new SEP and non-SET at home has yielded significantly better results in walking distance and QoL in the intervention group than in the controls",
"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",
"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",
"OBJECTIVES To determine the effects of resistance training combined with either moderate-intensity endurance or low-volume high-intensity interval training on cardiovascular risk profiles in patients with coronary artery disease . DESIGN Factorial repeated- measures study design . METHODS Nineteen patients were r and omized into moderate-intensity endurance ( n = 10 ) or high-intensity interval ( n = 9 ) groups , and attended 2 supervised exercise sessions a week for 6-months . The first 3-months involved exclusive moderate-intensity endurance or high-intensity interval exercise , after which progressive resistance training was added to both groups for the remaining 3-months . Fitness ( VO(2)peak ) , blood pressure and heart rate , lipid profiles and health related quality of life assessment s were performed at pretraining , 3 and 6-months training . RESULTS VO(2)peak increased from pretraining to 3-months in both groups ( moderate-intensity endurance : 19.8 ± 7.3 vs. 23.2 ± 7.4 ml kg(-1)min(-1 ) ; high-intensity interval : 21.1 ± 3.3 vs. 26.4 ± 5.2 ml kg(-1)min(-1 ) , p 6-months . Self-evaluated health and high-density lipoprotein were increased following 6-months of moderate-intensity endurance exercise , while all remaining indices were unchanged . Low-volume high-intensity interval exercise did not elicit improvements in lipids or health related quality of life . Blood pressures and heart rates were unchanged with training in both groups . CONCLUSIONS Findings from our pilot study suggest improvements in fitness occur within the first few months of training in patients with coronary artery disease , after which the addition of resistance training to moderate-intensity endurance and high-intensity interval exercise elicited no further improvements . Given the importance of resistance training in cardiac rehabilitation , additional research is required to determine its effectiveness when combined with high-intensity interval exercise",
" The aim of this study was to compare the effects of a single session of walking and combined exercise on oxidative stress and vascular function in peripheral arterial disease patients . Thirteen patients with peripheral arterial disease underwent two experimental sessions in r and om order : walking ( ten sets of 2‐min walking at the speed corresponding to the onset of claudication pain with 2‐min interval between sets ) and combined exercise ( 1 × 10 reps in eight resistance exercises plus five‐two‐minute sets of walking ) . Before and after the exercise , vascular function ( blood flow , leg vascular resistance and blood‐flow postreactive hyperaemia ) and oxidative stress ( malondialdehyde and plasma nitrite levels ) were obtained . Blood flow increased similarly after both sessions , whilst leg vascular resistance decreased similarly after both sessions . Plasma nitrite increased only after the combined exercise . Malondialdehyde decreased after both sessions , and the decrease was greater after combined exercise . As a conclusion , a single session of combined exercise improves blood flow and leg vascular resistance similarly to walking session ; however , combined exercise promoted better effects on oxidative stress",
"Introduction A typical symptom of chronic lower-limb ischaemia is lower-limb pain , which occurs during walking forcing the patient to stop , intermittent claudication ( IC ) . Exercise rehabilitation is the basic form of treatment for these patients . Aim The aim of this study was to compare the effectiveness of three types of physical training programmes conducted over a 12-week period in patients with chronic lower-limb arterial insufficiency . Material s and Methods Ninety-five people qualified for the 3-month supervised motor rehabilitation programme , conducted three times a week . The respondents were assigned to three types of rehabilitation programmes using a pseudo-r and omization method : Group I ( TW ) , subjects undertaking treadmill walking training ; Group II ( NW ) , subjects undertaking Nordic walking training ; Group III ( RES+NW ) , subjects undertaking resistance and Nordic walking training . Treadmill test , 6 Minute Walk Test ( 6MWT ) , and isokinetic test were repeated after 3 months of rehabilitation , which 80 people completed . Results Combined training ( RES+NW ) is more effective than Nordic walking alone and supervised treadmill training alone for improving ankle force-velocity parameters ( p patients with intermittent claudication . Each of the proposed exercise rehabilitation programmes increased walking distance of patients with intermittent claudication ( p force-velocity parameters are observed in the maximum distance obtained in 6MWT , both in Group III ( RES + NW ) and in Group II ( NW ) at the level of moderate and strong correlation strength , which indicates that if the lower limbs are stronger the walking distance achieved in 6MWT is longer . Conclusions Given both the force-velocity parameters and the covered distance , the training RES + NW gives the most beneficial changes compared to training TW alone and NW alone . All types of training increased walking distance , which is an important aspect of the everyday functioning of people with IC",
"Although exercise has well-documented health benefits on cardiovascular disease ( CVD ) , the benefit of combination exercise on CVD risk factors in individuals with elevated risk has not been fully eluci date d. We compared the effects of aerobic , resistance , and a combination of both aerobic and resistance training on CVD risk factors including peripheral and central BP , cardiorespiratory fitness ( CRF ) , muscular strength , body composition , blood glucose and lipids . Sixty-nine adults ( 58±7 years ) with an elevated blood pressure or hypertension , overweight/obesity , and sedentary lifestyle were r and omized to one of the three 8-week exercise programs or a non-exercise control group . Participants in all three exercise groups had an equal total exercise time , 3 days/week ( aerobic : 60 minutes/session vs. resistance : 60 minutes/session vs. combination : aerobic 30 minutes/session plus resistance 30 minutes/session ) . Combined training provided significant reductions in peripheral ( -4 mmHg ) and central diastolic BP ( -4 mmHg ) , increase in CRF ( 4.9 ml/kg/min ) , increase in upper ( 4 kg ) and lower ( 11 kg ) body strength , and increase in lean body mass ( 0.8 kg ) ( p Aerobic training only increased CRF ( 7.7 ml/kg/min ) , and reduced body weight ( -1.0 kg ) and fat mass ( -0.9 kg ) ( p Resistance training only increased lower body strength ( 13 kg ) and reduced waist circumference ( -1.7 cm ) ( p 0.05 ) . However , neither aerobic or resistance training alone showed significant reductions in BP ( p>0.05 ) . Furthermore , a composite score of CVD risk factors indicated a greater reduction with combination training compared to the control group . In conclusion , among individuals at an increased risk for CVD , as little as 8-weeks of combined training may provide more comprehensive CVD benefits compared to time-matched aerobic or resistance training alone",
"OBJECTIVE We used outdoor walking distance measured during 40 minutes as \" real-life \" outdoor walking capacity in 49 patients with intermittent claudication ( IC ) . The outdoor walking distance was measured by a global positioning system application for a smartphone . The relationships of self-reported maximum walking distance ( SR-MWD ) , the MWD on a grade d treadmill test , and the 6-minute maximum walk distance ( 6MWD ) vs outdoors walking capacity were investigated . Also studied were the associations of SR-MWD , MWD , and 6MWD with health-related quality of life assessed with the disease-specific instrument the Vascular Quality of Life Question naire ( VascuQoL ) . METHODS In this prospect i ve observational cohort study , 49 IC patients underwent an outdoor walking capacity test for 40 minutes , and MWD and 6MWD were measured . SR-MWD was recorded , and all subjects completed the VascuQoL question naire . Associations between the different walk estimates and outdoor walking capacity and health-related quality of life were investigated by correlation analysis ( Spearman ρ ) . RESULTS Outdoor walking distance during 40 minutes was a median 2495 m ( range , 1110 - 3300 m ) . SR-MWD correlated moderately and MWD correlated strongly to outdoor walking capacity ( r = 0.56 and r = 0.65 ; P the outdoor walking capacity ( r = 0.78 ; P the VascuQoL sum score ( r = 0.53 ; P outdoor walking capacity and health-related quality of life in IC patients . Our data support the use of 6MWD for routine clinical evaluation of walking capacity in IC patients"
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BACKGROUND This review was design ed to assess the evidence from r and omized controlled trials on effects of probiotics in the treatment and prevention of acute infectious diarrhea in infants and children . METHODS A systematic review of published , r and omized , double-blind , placebo-controlled trials on probiotics in the treatment or prevention of acute diarrhea defined as > 3 loose or watery stools per 24 hours in infants and children . RESULTS The use of probiotics as compared with placebo was associated with a significantly reduced risk of diarrhea lasting > 3 days . The pooled estimate risk was 0.43 ( 95 % CI , 0.34 - 0.53 ) with a fixed-effect model , and remained significant in a r and om-effect model ( 0.40 ; 95 % CI , 0.28 - 0.57 ) . Only Lactobacillus GG showed a consistent effect . Probiotics significantly reduced the duration of diarrhea when compared with placebo , particularly in rotaviral gastroenteritis-the pooled , weighted , mean difference ( WMD ) assuming the r and om-effect model was -20.1 hours ( 95 % CI , -26.1 to -14.2 ) and -24.8 ( 95 % CI , -31.8 to -17.9 ) respectively . A meta- analysis of the prevention studies was not feasible because of significant clinical and statistical heterogeneity . CONCLUSIONS There is evidence of a clinical ly significant benefit of probiotics in the treatment of acute infectious diarrhea in infants and children , particularly in rotaviral gastroenteritis . Lactobacillus GG showed the most consistent effect , although other probiotic strains may also be effective . Further research is needed . Clinical and statistical heterogeneity of the prophylactic interventions preclude drawing firm conclusions about the efficacy of probiotics in preventing acute gastroenteritis
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"The aim of this study was to determine if supplementation of healthy children with milk fermented by yogurt cultures and Lactobacillus casei strain DN-114 001 could affect the incidence of acute diarrhoea when compared with traditional yogurt . The study was a multicentre , r and omised , double-blind trial , conducted over four months , on 928 children aged , at inclusion , 6 - 24 months . The study consisted of two periods : supplementation and observation . Subjects were supplemented daily with 100 g of one of the two dairy products being tested : st and ard yogurt and milk fermented by yogurt cultures and Lactobacillus casei ( 10(8 ) cfu/ml ) . Frequency or duration of any diarrhoea episode was evaluated . As far as frequency was concerned there was a statistically significant difference between the groups , the incidence of diarrhoea being significantly reduced by supplementation with L. casei fermented milk ( 15.9 % ) compared with yogurt ( 22 % ) ( p = 0.03 ) . These results suggest an additional benefit of L. casei in acute diarrhoea in children compared with st and ard yogurt",
"ABSTRACT : Human Lactobacillus sp strain GG ( Lactobacillus GG ) administered during acute rotavirus diarrhea has been shown to promote clinical recovery . To eluci date the immune mechanisms behind such a favorable outcome , the ELISPOT ( solid phase enzyme-linked immunospot ) assay of Ig- and specific antibody-secreting cells among circulating lymphocytes was used , giving indirect evidence of the immunologic events in the gut . After rehydration , 39 children with acute rotavirus diarrhea , mean age 16 ( SD 6 ) mo , r and omly received either a Lactobacillus GG fermented milk product ( study group ) or a pasteurized yogurt ( placebo group ) . The duration of diarrhea was significantly shorter in the study group than in the placebo group [ mean 1.1 ( SD 0.6 ) versus 2.5 ( SD 1.4 ) d , p = 0.001 ] . Lactobacillus GG therapy was associated with a significantly enhanced nonspecific humoral response during the acute phase of the infection , reflected in the IgG , IgA , and IgM Ig-secreting cell numbers . At convalescence , 90 % of the study group versus 46 % of the placebo group had developed an IgA specific antibody-secreting cell response to rotavirus ( p = 0.006 ) . The results indicate that Lactobacillus GG promotes recovery from rotavirus diarrhea via augmentation of the local immune defense . Furthermore , specific IgA response to rotavirus is endorsed , which is possibly relevant in protection against reinfections",
"In a controlled trial in Petrozavodsk , Karelia , the effects of oral rehydration and Lactobacillus strain GG ( LGG ) on recovery from acute diarrhoea ( 27 % rotavirus , 21 % bacterial aetiology ) were studied in 123 children aged between 1 and 36 months of age . On admission to hospital , the patients were first r and omized to receive either isotonic oral rehydration solution ( ORS ) with osmolality 311mosmol/l and sodium 90mmol/l ( WHO‐ORS ) , or a hypotonic ORS with osmolality 224mosmol/l and sodium 60mmol/l ( Light‐ORS ) , and thereafter r and omized to receive either 5 × 109 colony forming units of LGG or a matching placebo . The two ORS performed equally for acute rehydration , and oral rehydration with either ORS was associated with a shorter duration of diarrhoea than intravenous rehydration ( p= 0.036 ) . Patients receiving LGG had a significantly shorter duration of watery diarrhoea [ mean ( SD ) 2.7 ( 2.2 ) days ] than those receiving the placebo [ 3.7 ( 2.8 ) days , p= 0.03 ] . LGG significantly shortened the duration of rotavirus diarrhoea but not diarrhoea with confirmed bacterial aetiology",
"We compared different lactic acid bacteria for their effect on the immune response to rotavirus in children with acute rotavirus gastroenteritis . After initial oral rehydration , 49 children aged 6 to 35 months with rotavirus gastroenteritis r and omly received cither Lactobacillus casei subsp . casei strain GG ( LGG ) , L. casei subsp . rhamnosus ( Lactophilus ) , or a combination of Streptococcus thermophilus and L. delbriickii subsp . bulgaricus ( Yalacta ) twice daily for 5 days . Serum antibodies to rotavirus , total number of immunoglobulin-sec rct ing cells ( ISC ) , and specific antibody-secreting cells ( sASC ) to rotavirus were measured at the acute stage and at convalescence . The mean ( SD ) duration of diarrhea was 1.8 ( 0.8 ) days in children who received LGG , 2.8 ( 1.2 ) days in those receiving Lactophilus , and 2.6 ( 1.4 ) days in those receiving Yalacta ( F = 3.3 , p = 0.04 ) . The ISC response was comparable in the three study groups , but the rotavirus-specific immune responses were different . LGG therapy was associated with an enhancement of IgA sASC to rotavirus and serum IgA antibody level at convalescent stage . We conclude that certain strains of lactic acid bacteria , particularly LGG , promote serum and intestinal immune responses to rotavirus , and thus may be important in establishing immunity against rotavirus",
"BACKGROUND Oral administration of live Lactobacillus casei strain GG is associated with the reduction of duration of diarrhea in children admitted to the hospital because of diarrhea . The purpose s of this work were to investigate the clinical efficacy of oral administration of Lactobacillus in children with mild diarrhea who were observed as out patients , and to see whether Lactobacillus GG can reduce the duration of rotavirus excretion . METHODS Duration of diarrhea was recorded in 100 children seen by family pediatricians and r and omly assigned to receive oral rehydration or oral rehydration followed by the administration of lyophilized Lactobacillus casei , strain GG . Rotavirus was looked for in the stools of all children and in those in whom results were positive , stools were examined again 6 days after the onset of diarrhea . RESULTS In 61 children results were positive for rotavirus and in 39 results were negative . Duration of diarrhea was reduced from 6 to 3 days in children receiving Lactobacillus GG , with a similar pattern in rotavirus-positive and -negative children . Six days after the onset of diarrhea , stools in only 4 out of 31 children that received Lactobacillus GG were positive for rotavirus compared with positive findings in 25 out of 30 control subjects . CONCLUSIONS Oral administration of Lactobacillus GG is effective in rotavirus-positive and rotavirus-negative ambulatory children with diarrhea . Furthermore , it reduces the duration of rotavirus excretion",
"A prospect i ve , placebo controlled , triple blind clinical trial was undertaken in Thail and to determine the effect of Lactobacillus GG on recovery from acute diarrhoea in children . Thirty-nine children ( mean age = 8 months ) were enrolled and following rehydration received either oral Lactobacillus GG ( n = 20 ) as a freeze-dried preparation or placebo ( n = 19 ) twice daily for 2 days . The clinical characteristics of the study groups were similar . There was no significant difference overall in clinical response detected between the study groups . When only those with acute non-bloody diarrhoea ( n = 26 ) were considered , the mean duration of diarrhoea was significantly shorter in the lactobacillus group ( 1.9 days ) than in the placebo group ( 3.3 days ) ( P Stool frequency was less on the second day in the lactobacillus group ( P recovery from acute watery diarrhoea in young children in a tropical setting",
"Two hypotonic oral rehydration solutions with osmolarities of 224 mosmol/l ( Na+ 60 mmol/l , glucose 84 mmol/l ) and 204 mosmol/l ( Na+ 60 mmol/l , glucose 64 mmol/l ) , respectively , and oral treatment withLactobacillus GG were evaluated in a double blind trial in children aged 6–36 months hospitalised for acute diarrhoea . Early administration ofLactobacillus GG at the start of oral rehydration result ed in the shortest duration of diarrhoea , best weight gain , and fastest correction of acidosis . A reduced osmolarity oral rehydration solution ( 224 mosmol/l ) combined with early administration of Lactobacillus GG is an effective treatment for acute diarrhoea in young children ; further reduction of osmolarity may not be beneficial",
"BACKGROUND Addition of a medication to the World Health Organization protocol for treatment of acute diarrhea in children is controversial . In this trial , the clinical efficacy of a medication ( Lactéol Fort sachets ; Laboratoire du Lactéol du Docteur Boucard , Houdan France ) containing lyophilized heat-killed Lactobacillus acidophilus LB was assessed as an adjunct to oral rehydration therapy . METHODS Children aged 3 to 24 months with acute diarrhea and mild or moderate dehydration were enrolled in the study . Children received oral rehydration therapy for the first 4 hours . After this first rehydration phase , undiluted milk formula or breast milk was fed alternately with oral rehydration solution . Children were fed rice gruel as tolerated . They received either one sachet containing 10 billion of lyophilized heat-killed L. acidophilus LB or placebo at admission and at 12-hour intervals for five doses . RESULTS Seventy-three children ( 37 L. acidophilus LB , 36 placebo ) were enrolled , of whom 40 ( 17 L. acidophilus LB , 23 placebo ) received an antibiotic before inclusion . Rotavirus was identified in approximately 50 % of the children in each group . After 24 hours of treatment , the number of rotavirus-positive children with watery stools was significantly lower ( p = 0.012 ) in the L. acidophilus LB group . Mean duration of diarrhea was decreased ( p = 0.034 ) with L. acidophilus LB ( 43.4 hours ) versus placebo ( 57.0 hours ) . This decreased duration was particularly marked in children with no antibiotic therapy before inclusion ( 31.1 hours ) : 42.9 hours for the L. acidophilus LB group versus 74.0 hours for the placebo group ( p = 0.016 ) . CONCLUSIONS Addition of L. acidophilus LB to oral rehydration therapy was effective in the treatment of children with acute diarrhea by decreasing the duration of diarrhea",
"BACKGROUND Certain lactic acid bacteria may accelerate recovery from acute diarrhea . Lactobacillus reuteri is a commonly occurring Lactobacillus species with therapeutic potential in diarrhea . DESIGN Prospect i ve , r and omized , placebo-controlled trial in two hospitals . METHODS Children between 6 and 36 months of age admitted for rotavirus-associated diarrhea were r and omized into three groups to receive either 10(10 ) or 10(7 ) colony-forming units ( cfu ) of L. reuteri or a matching placebo once a day for up to 5 days . RESULTS The main effect of L. reuteri was on the duration of watery diarrhea . The mean ( + /-SD ) duration of watery diarrhea after initiation of treatment was 2.5 ( 1.5 ) days in the placebo group ( n = 25 ) vs. 1.9 ( 0.9 ) days in the small dosage ( n = 20 ) and 1.5 ( 1.1 ) days in the large dosage ( n = 21 ) L. reuteri recipients ( P = 0.01 ) . By the second day of treatment watery diarrhea persisted in 80 % of the placebo , 70 % of the small dosage and 48 % of the large dosage L. reuteri recipients ( P = 0.04 , large dosage vs. placebo ) . Stool cultures for lactobacilli confirmed that administration of L. reuteri result ed in good colonization of the GI tract . The mean ( + /-SD ) of total Lactobacillus count 2 days after treatment initiation was 2.8 ( 1.6 ) log 10 cfu/g in the placebo group , 4.5 ( 2.0 ) log 10 cfu/g in the small dosage L. reuteri group and 6.1 ( 1.2 ) log 10 cfu/g in the large dosage L. reuteri group ( P = 0.0004 ) . CONCLUSIONS L. reuteri effectively colonized the gastrointestinal tract after administration and significantly shortened the duration of watery diarrhea associated with rotavirus . There was a correlation between the dosage of L. reuteri and the clinical effect",
"BACKGROUND The probiotic Lactobacillus GG is effective in promoting a more rapid recovery of acute , watery diarrhea in children with rotavirus enteritis . Very limited information is available , however , on the potential role of such agents in non-rotaviral diarrheal episodes . Furthermore , no evidence is available concerning the efficacy of Lactobacillus GG administered in the oral rehydration solution during oral rehydration therapy . A multicenter trial was conducted to evaluate the efficacy of Lactobacillus GG administered in the oral rehydration solution to patients with acute-onset diarrhea of all causes . METHODS Children 1 month to 3 years of age with acute-onset diarrhea were enrolled in a double-blind , placebo-controlled investigation . Patients were r and omly allocated to group A , receiving oral rehydration solution plus placebo , or group B , receiving the same preparation but with a live preparation of Lactobacillus GG ( at least 10(10 ) CFU/250 ml ) . After rehydration in the first 4 to 6 hours , patients were offered their usual feedings plus free access to the same solution until diarrhea stopped . RESULTS One hundred forty children were enrolled in group A , and 147 in group B. There were no differences at admission between the groups in age , sex , previous types of feeding , previous duration of diarrhea , use of antibiotics , weight , height , weight-height percentile , prevalence of fever , overall status , degree of dehydration , and percentage of in- versus out patients . Duration of diarrhea after enrollment was 71.9 + /- 35.8 hours in group A versus 58.3 + /- 27.6 hours in group B ( mean + /- SD ; P = 0.03 ) . In rotavirus-positive children , diarrhea lasted 76.6 + /- 41.6 hours in group A versus 56.2 + /- 16.9 hours in groups B ( P Diarrhea lasted longer than 7 days in 10.7 % of group A versus 2.7 % of group B patients ( P Hospital stays were significantly shorter in group B than in group A. CONCLUSIONS Administering oral rehydration solution containing Lactobacillus GG to children with acute diarrhea is safe and results in shorter duration of diarrhea , less chance of a protracted course , and faster discharge from the hospital",
"OBJECTIVE Lactobacillus GG ( L-GG ) , an acid- and bile-resistant strain that colonizes the intestinal mucosa , has been used to manage diarrhea in children . Our objective was to evaluate the prophylactic use of L-GG to prevent diarrhea in children at high risk from a developing country in a r and omized , placebo-controlled trial . STUDY DESIGN Two hundred four undernourished children 6 to 24 months old from an indigent peri-urban Peruvian town received either L-GG or placebo in flavored gelatin once daily , 6 days a week , for 15 months . Episodes of diarrhea were documented by daily home visits , and diagnostic studies were done in a subset of cases . Recovery of L-GG in stool from subjects and from family contacts was examined . RESULTS Subjects in the L-GG group had significantly fewer episodes of diarrhea ( 5.21 episodes diarrhea/child/year [ ' ecy ' ] L-GG group , 6 . 02 ecy placebo group ; P = .028 ) . The decreased incidence of diarrhea in the L-GG group was greatest in the 18- to 29-month age group ( P = . 004 ) and was largely limited to nonbreastfed children ( Breastfed : 6 . 59 ecy L-GG , 6.32 ecy placebo , P = .7 ; Nonbreastfed : 4.69 ecy L-GG , 5 . 86 ecy placebo , P = .005 ) . The duration of diarrhea episodes and the causes of diarrhea were similar in both groups , except adenovirus was more common in the placebo group . CONCLUSION L-GG supplementation may be useful as a prophylactic measure to control diarrhea in undernourished children at increased risk , especially nonbreastfed children in the toddler age group",
"The objective of this study was to determine if supplementation with milk fermented by yogurt cultures and Lactobacillus casei ( strain DN-114 001 ) could lessen acute diarrhoea in healthy children . The study was conducted over six months , with 287 children aged 18.9 ( SD 6.0 ) months , comprising three periods of one month supplementation , each month being followed by one month without supplementation . Subjects were supplemented daily with either 125 g or 250 g ( according to age ) of one of three tested dairy products : st and ard yogurt , milk fermented by yogurt cultures and Lactobacillus casei ( 10(8 ) cfu/ml ) , or a jellied milk ( control product ) . A daily record was kept of the number and type of stools . Although the incidence of diarrhoea was not shown to be different between the groups , the severity of diarrhoea over the six-month study was significantly decreased ( 4.3 days ) with the supplementation of L. casei fermented milk compared with the jellied milk ( 8.0 days ) ( p = 0.009 )",
"To determine the effect of a human Lactobacillus strain ( Lactobacillus casei sp strain GG , Gefilac ) on recovery from acute diarrhea ( 82 % rotavirus ) , 71 well-nourished children between 4 and 45 months of age were studied . After oral rehydration , the patients r and omly received either Lactobacillus GG-fermented milk product , 125 g ( 10(10 - 11 ) colony-forming units ) twice daily ( group 1 ) ; Lactobacillus GG freeze-dried powder , one dose ( 10(10 - 11 ) colony-forming units ) twice daily ( group 2 ) ; or a placebo , a pasteurized yogurt ( group 3 ) 125 g twice daily ; each diet was given for 5 days , in addition to normal full diet otherwise free of fermented dairy products . The mean ( SD ) duration of diarrhea after commencing the therapy was significantly shorter in group 1 ( 1.4 [ 0.8 ] days ) and in group 2 ( 1.4 [ 0.8 ] days ) than in group 3 ( 2.4 [ 1.1 ] days ) ; F = 8.70 , P less than 0.001 . After rehydration , each dietary group maintained a positive weight trend . The urinary lactulose-mannitol recovery ratios ( means [ 95 % confidence intervals ] ) on admission were 0.09 ( 0.03 , 0.24 ) in group 1 , 0.12 ( 0.07 , 0.22 ) in group 2 , and 0.08 ( 0.04 , 0.18 ) in group 3 ; no significant alterations in intestinal permeability were observed at retesting after 2 days of realimentation . The result indicates that early nutritional repletion after rehydration causes no mucosal disruption and is beneficial for recovery from diarrhea . It is further suggested that Lactobacillus GG in the form of fermented milk or freeze-dried powder is effective in shortening the course of acute diarrhea",
"BACKGROUND Certain strains of lactobacilli may promote recovery from acute diarrhea . Lactobacillus reuteri is of human origin and is a natural colonizer of gastrointestinal tract . In this trial , exogenously administered L. reuteri was studied as a therapeutic agent in acute diarrhea . METHODS Forty patients between 6 and 36 months of age hospitalized with acute diarrhea ( 75 % rotavirus ) were studied . After parental consent , the patients were r and omized to one of two treatment groups to receive either 10(10 ) to 10(11 ) colony-forming units of L. reuteri or a matching placebo daily for the length of hospitalization or up to 5 days . The clinical outcome of diarrhea and colonization of L. reuteri were evaluated . RESULTS The mean ( SD ) duration of watery diarrhea after treatment was 1.7 ( 1.6 ) days in the L. reuteri group and 2.9 ( 2.3 ) days in the placebo group ( p = 0.07 ) . On the second day of treatment only 26 % of patients receiving L. reuteri had watery diarrhea , compared with 81 % of those receiving placebo ( p = 0.0005 ) . Cultures of lactobacilli from stool sample s demonstrated that administration of L. reuteri result ed in colonization of the gastrointestinal tract . Lactobacillus reuteri accounted for > 75 % of the total lactobacilli found in children fed with this product . CONCLUSIONS Lactobacillus reuteri is effective as a therapeutic agent in acute rotavirus diarrhea in children . Further studies are warranted to confirm the present finding and to explore the full therapeutic potential of L. reuteri in acute viral diarrhea",
"A prospect i ve , placebo-controlled , triple blind clinical trial was carried out in Pakistan to determine the effect of Lactobacillus GG on the course of acute diarrhea in hospitalized children . Forty children ( mean age , 13 months ) were enrolled and after rehydration received either oral Lactobacillus GG ( n = 21 ) or placebo ( n = 19 ) twice daily for 2 days , in addition to the usual diet . The clinical course of diarrhea was followed during the treatment period . Features on admission into the study groups were similar and were characterized by severe diarrhea , malnutrition and inappropriate management before presentation . Response was evident on Day 2 when the frequency of both vomiting and diarrhea was less in the Lactobacillus group . In those who had presented with acute nonbloody diarrhea ( n = 32 ) , the percentage of children with persistent watery diarrhea at 48 hours was significantly less in the Lactobacillus group : 31 % vs. 75 % ( P No significant difference was observed by 48 hours in those presenting with bloody diarrhea . The relevance of this finding to the management of diarrhea in the tropics is discussed",
"Acute diarrhoea is a serious cause of infant morbidity and mortality , and the development of preventive measures remains an important goal . Bifidobacteria ( which constitute the predominant intestinal flora of breastfed infants ) , as well as other lactic-acid-producing organisms such as Streptococcus thermophilus , are thought to have a protective effect against acute diarrhoeal disease . However , their efficacy has not been assessed in controlled trials . In a double-blind , placebo-controlled trial , infants aged 5 - 24 months who were admitted to a chronic medical care hospital were r and omised to receive a st and ard infant formula or the same formula supplemented with Bifidobacterium bifidum and S thermophilus . Patients were evaluated daily for occurrence of diarrhoea , and faecal sample s , obtained weekly , were analysed for rotavirus antigen by enzyme immunoassay . Faecal sample s were also obtained during an episode of diarrhoea for virological and bacteriological analyses . 55 subjects were evaluated for a total of 4447 patient-days during 17 months . 8 ( 31 % ) of the 26 patients who received the control formula and 2 ( 7 % ) of 29 who received the supplemented formula developed diarrhoea during the course of the study ( p = 0.035 , Fisher 's exact test , two-tailed ) . 10 ( 39 % ) of the subjects who received the control formula and 3 ( 10 % ) of those who received the supplemented formula shed rotavirus at some time during the study ( p = 0.025 ) . The supplementation of infant formula with B bifidum and S thermophilus can reduce the incidence of acute diarrhoea and rotavirus shedding in infants admitted to hospital"
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Water-based exercises are recommended for people with osteoarthritis ( OA ) , due to the beneficial effects on physical function , quality of life and symptom reduction . However , the effects on muscle strength are still controversial . The aim of this review was to assess and compare the effects of aquatic exercise programs on muscle strength and physical function in people with OA . A systematic search was performed at Pubmed , Scopus and Web of Science data bases . Clinical trials with interventions involving aquatic exercises for individuals with OA were included . The method ological quality of the studies was evaluated using the PEDro scale . 296 studies were found and twelve were selected : six studies comparing water-based exercises with l and -based exercise , and six comparing water-based exercise groups with the control group . Exercise programs included muscle strengthening , aerobic , balance , flexibility and stretching exercises . Duration of the program , weekly frequency , intensity and progression varied between studies . Beneficial effects of aquatic exercise were found on physical function . However , only two of five studies that assessed muscle strength observed positive effect of aquatic exercise . Although it is difficult to compare studies and establish guidelines for the st and ardized protocol formulation , it was observed that water-based exercises can be effective on improving physical function and increasing muscle strength , since they are well-structured , with exercise intensity and overload controlled
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"OBJECTIVE To compare the efficacy of aquatic exercise and a l and -based exercise programme vs control in patients with knee osteoarthritis . METHODS Primary outcome was change in pain , and in addition Knee Injury and Osteoarthritis Outcome Score question naire ( KOOS ) . St and ing balance and strength was also measured after and at 3-month follow-up . Seventy-nine patients ( 62 women ) , with a mean age of 68 years ( age range 40 - 89 years ) were r and omized to aquatic exercise ( n = 27 ) , l and -based exercise ( n = 25 ) or control ( n = 27 ) . RESULTS No effect was observed immediately after exercise cessation ( 8 weeks ) . At 3-month follow-up a reduction in pain was observed only in the l and -based exercise group compared with control ( -8.1 mm , ( 95 % confidence interval -15.4 to -0.4 ; p = 0.039 ) , but no differences between groups were observed for KOOS ; and no improvement following aquatic exercise . Eleven patients reported adverse events ( i.e. discomfort ) in l and -based exercise , while only 3 reported adverse events in the aquatic exercise . CONCLUSION Only l and -based exercise showed some improvement in pain and muscle strength compared with the control group , while no clinical benefits were detectable after aquatic exercise compared with the control group . However , aquatic exercise has significantly less adverse effects compared with a l and -based programme",
"OBJECTIVE To evaluate the effect of aquatic exercise and education on fall risk factors in older adults with hip osteoarthritis ( OA ) . METHOD Seventy-nine adults , 65 years of age or older with hip OA and at least 1 fall risk factor , were r and omly assigned to 1 of 3 groups : aquatics and education ( AE ; aquatic exercise twice a wk with once-a-wk group education ) , aquatics only ( A ; 2 wk aquatic exercise ) and control ( C ; usual activity ) . Balance , falls efficacy , dual-task function , functional performance ( chair st and s ) , and walking performance were measured pre- and postintervention or control period . RESULTS There was a significant improvement in fall risk factors ( full-factorial MANCOVA , baseline values as covariates ; p = .038 ) ; AE improved in falls efficacy compared with C and in functional performance compared with A and C. CONCLUSION The combination of aquatic exercise and education was effective in improving fall risk factors in older adults with arthritis",
"Background Aquatic exercise is recommended by the Osteoarthritis Research Society ( OARSI ) , by the American College of Rheumatology ( ACR ) and by the European League Against Rheumatism ( EULAR ) as a nonpharmacological method of controlling the knee osteoarthritis ( KOA ) symptoms . Moreover , given that weight loss results in a reduction of the load that is exerted upon the knee during daily activities , obesity is also considered to be a modifiable risk factor for the development and or exacerbation of KOA . The implementation of an exercise based weight loss program may , however , itself be limited by the symptoms of KOA . The aquatic program against osteoarthritis ( termed “ PICO ” in Portuguese ) prioritizes the control of symptoms and the recovery of functionality , with an attendant increase in the patient ’s physical activity level and , consequently , metabolic rate . Our laboratory is assessing the effectiveness of 3 months of PICO on the symptoms of KOA , on physical function , on quality of life and on gait . In addition , PICO shall examine the effects of said exercise intervention on inflammatory biomarkers , psychological health , life style and body composition . Methods / Design The trial is a prospect i ve , single-blinded , r and omized controlled trial , and involves 50 overweight and obese adults ( BMI = 28–43.5 kg/m2 ; age 40–65 yrs ) with radiographic KOA . The participants are r and omly allocated into either an educational attention ( control ) group or an aquatic ( exercise program ) group . This paper describes the experimental protocol that is used in the PICO project . Discussion The PICO program shall provide insight into the effectiveness of an aquatic exercise program in the control of KOA symptoms and in the improvement of the quality of life . As such , they are likely to prove a useful reference to health professionals who intend to implement any kind of therapeutic intervention based around aquatic exercise . Trial registration NCT01832545",
"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 and Purpose Aquatic physical therapy is frequently used in the management of patients with hip and knee osteoarthritis ( OA ) , yet there is little research establishing its efficacy for this population . The purpose of this study was to evaluate the effects of aquatic physical therapy on hip or knee OA . Subjects A total of 71 volunteers with symptomatic hip OA or knee OA participated in this study . Methods The study was design ed as a r and omized controlled trial in which participants r and omly received 6 weeks of aquatic physical therapy or no aquatic physical therapy . Outcome measures included pain , physical function , physical activity levels , quality of life , and muscle strength . Results The intervention result ed in less pain and joint stiffness and greater physical function , quality of life , and hip muscle strength . Totals of 72 % and 75 % of participants reported improvements in pain and function , respectively , compared with only 17 % ( each ) of control participants . Benefits were maintained 6 weeks after the completion of physical therapy , with 84 % of participants continuing independently . Discussion and Conclusion Compared with no intervention , a 6-week program of aquatic physical therapy result ed in significantly less pain and improved physical function , strength , and quality of life . It is unclear whether the benefits were attributable to intervention effects or a placebo response",
"OBJECTIVE To investigate whether an exercise program , initially focusing on knee stabilization and subsequently on muscle strength and performance of daily activities is more effective than an exercise program focusing on muscle strength and performance of daily activities only , in reducing activity limitations in patients with knee osteoarthritis ( OA ) and instability of the knee joint . DESIGN A single-blind , r and omized , controlled trial involving 159 knee OA patients with self-reported and /or biomechanically assessed knee instability , r and omly assigned to two treatment groups . Both groups received a supervised exercise program for 12 weeks , consisting of muscle strengthening exercises and training of daily activities , but only in the experimental group specific knee joint stabilization training was provided . Outcome measures included activity limitations ( Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC physical function , primary outcome ) , pain , global perceived effect and knee stability . RESULTS Both treatment groups demonstrated large ( ∼20 - 40 % ) and clinical ly relevant reductions in activity limitations , pain and knee instability , which were sustained 6 months post-treatment . No differences in effectiveness between experimental and control treatment were found on WOMAC physical function ( B ( 95 % confidence interval - CI ) = -0.01 ( -2.58 to 2.57 ) ) or secondary outcome measures , except for a higher global perceived effect in the experimental group ( P = 0.04 ) . CONCLUSIONS Both exercise programs were highly effective in reducing activity limitations and pain and restoring knee stability in knee OA patients with instability of the knee . In knee OA patients suffering from knee instability , specific knee joint stabilization training , in addition to muscle strengthening and functional exercises , does not seem to have any additional value . Dutch Trial Register ( NTR ) registration number : NTR1475",
"AIMS The study aims to compare changes over time among three study groups on the primary outcome , pain , as well as on the secondary outcomes , other symptoms , activities of daily living function , sport and recreation function , knee-related quality of life , knee range of motions and the six-minute walk test and to investigate whether aquatic exercises would be superior compared with l and exercise on pain reduction . BACKGROUND Osteoarthritis is a prevalent musculoskeletal disorder . Appropriate exercise may prevent osteoarthritis-associated disabilities and increase life quality . To date , research that compares the effects of different types of exercise for knee osteoarthritis has been limited . DESIGN The study is a r and omised trial . METHODS Eighty-four participants with knee osteoarthritis were recruited from local community centres . Participants were r and omly assigned to the control , aquatic or l and -based exercise group . Exercise in both groups ran for 60 minutes , three times a week for 12 weeks . Data were collected at baseline , week 6 and week 12 during 2006 - 2007 . The instruments included the Knee Injury and Osteoarthritis Outcome Score , a st and ard plastic goniometer and the six-minute walk test . Generalised estimation equations were used to compare changes over time among groups for key outcomes . RESULTS Results showed statistically significant group-by-time interactions in pain , symptoms , sport/recreation and knee-related quality of life dimensions of Knee Injury and Osteoarthritis Outcome Score , knee range of motions and the six-minute walk test . However , the aquatic group did not show any significant difference from the l and group at both weeks 12 and 6 . CONCLUSIONS Both aquatic and l and -based exercise programmes are effective in reducing pain , improving knee range of motions , six-minute walk test and knee-related quality of life in people with knee osteoarthritis . The aquatic exercise is not superior to l and -based exercise in pain reduction . RELEVANCE TO CLINICAL PRACTICE Similar outcomes could be possible with the two programmes . Health care professionals may consider suggesting well- design ed aquatic or l and -based exercise classes for patients with osteoarthritis , based on their preferences and convenience",
"OBJECTIVE To ascertain the effectiveness of the National Arthritis Foundation ( NAF ) aquatic and on-l and exercise programs on functional fitness and perceived ability to perform activities of daily living ( ADL ) measures in older adults with arthritis . DESIGN The effects of aquatic and on-l and exercise intervention programs were analyzed by repeated- measures analysis of variance by using a planned comparison approach with an independent 3 x 2 ( group by test ) design . omega(2 ) analyses were used to ascertain the relative treatment magnitude of each dependent variable . SETTING Testing in an indoor track facility ; exercise programs conducted in community setting s. PARTICIPANTS A volunteer sample of 30 men and women with arthritis ( osteoarthritis , n=22 ; rheumatoid arthritis , n=8 ) , r and omly assigned into either an aquatic exercise ( n=10 ) , on-l and exercise ( n=10 ) , or control group ( n=10 ) . INTERVENTION Eight-week on-l and and aquatic exercise program . MAIN OUTCOME MEASURES Functional fitness , ADLs , and h and -held dynamometry measures assessed on a 1-day pretest and posttest session , before and after an 8-week exercise program . RESULTS Aquatic and on-l and exercise subjects showed significant improvements on 9 of 12 functional fitness , 3 of 4 ADLs , and 7 of 8 h and -held isometric strength tests after their respective exercise programs . No significant changes were found in any of these measures for the control group . CONCLUSION Both NAF exercise programs appear to be effective in improving functional physical fitness and perceived ability to perform ADL measures in older adults with arthritis",
"AIM The purpose of the present study was to determine the effects of a water-based exercise program on muscle function compared with regular high-intensity resistance training . METHODS Older women ( n = 87 ) were recruited from the local community . The inclusion criteria were , to be aged 60 years or older , able to walk and able to carry out daily living activities independently . Participants were r and omly assigned to one of the following groups : water-based exercises ( WBG ) , resistance training ( RTG ) or control ( CG ) . The experimental groups carried out 12 weeks of an excise program performed on water or on l and . The dynamic strength , the isometric peak , and rate of torque development for the lower limbs were assessed before and after interventions . RESULTS The water-based program provided a similar improvement in dynamic strength in comparison with resistance training . The isometric peak torque increased around the hip and ankle joints in the water-based group , and around the knee joint in the resistance-training group ( P rate of torque development increased only in the water-based group around the hip extensors muscles ( P Water-based programs constitute an attractive alternative to promote relevant strength gains using moderate loads and fast speed movements , which were also effective to improve the capacity to generate fast torques",
"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",
"AIM This paper reports a study of the effects of aquatic exercise on physical fitness ( flexibility , strength and aerobic fitness ) , self-reported physical functioning and pain in adults with osteoarthritis of the hip or knee . BACKGROUND Osteoarthritis is a common cause of disability and a primary reason for hip and knee joint replacement . Exercise is important for preventing and /or managing the functional limitations associated with joint disease . Aquatic exercise is thought to be beneficial and is often recommended for people with osteoarthritis ; however , few studies have examined the effects on people with osteoarthritis , and these have yielded inconsistent results . METHODS A two-group r and omized controlled trial with a convenience sample was used . Participants were recruited from community sources and r and omly assigned to a 12-week aquatic programme or a non-exercise control condition . Data for 38 participants were collected at baseline , week 6 , and week 12 during 2003 and 2004 . Instruments were a st and ard plastic goniometer , a h and held dynamometer , the 6-minute walk test , the multidimensional Health Assessment Question naire , and a visual analogue scale for pain . RESULTS Repeated measures analysis of variance showed that aquatic exercise statistically significantly improved knee and hip flexibility , strength and aerobic fitness , but had no effect on self-reported physical functioning and pain . The exercise adherence rate was 81.7 % , and no exercise-related adverse effect was observed or reported . CONCLUSIONS Beneficial short-term effects of aquatic exercise were found in adults with osteoarthritis of the hip or knee . Although the programme may not offer pain relief or self-reported improvements in physical functioning , results suggest that aquatic exercise does not worsen the joint condition or result in injury . Nurses engaging in disease management and health promotion for these patients should consider recommending or implementing aquatic classes for patients",
"Background and Purpose : This study was design ed to evaluate the effectiveness of hydrotherapy in subjects with osteoarthritis ( OA ) of the knee compared with subjects with OA of the knee who performed l and -based exercises . Subjects and Methods : Sixty-four subjects with OA of the knee were r and omly assigned to 1 of 2 groups that performed exercises for 18 weeks : a water-based exercise group and a l and -based exercise group . The outcome measures included a visual analog scale ( VAS ) for pain in the previous week , the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , pain during gait assessed by a VAS at rest and immediately following a 50-foot ( 15.24-m ) walk test ( 50FWT ) , walking time measured at fast and comfortable paces during the 50FWT , and the Lequesne Index . Measurements were recorded by a blinded investigator at baseline and at 9 and 18 weeks after initiating the intervention . Results : The 2 groups were homogenous regarding all parameters at baseline . Reductions in pain and improvements in WOMAC and Lequesne index scores were similar between groups . Pain before and after the 50FWT decreased significantly over time in both groups . However , the water-based exercise group experienced a significantly greater decrease in pain than the l and -based exercise group before and after the 50FWT at the week-18 follow-up . Discussion and Conclusion : Both water-based and l and -based exercises reduced knee pain and increased knee function in participants with OA of the knee . Hydrotherapy was superior to l and -based exercise in relieving pain before and after walking during the last follow-up . Water-based exercises are a suitable and effective alternative for the management of OA of the knee",
"OBJECTIVE To investigate the efficacy of a water-based exercise program specifically targeting balance to reduce falls risk and improve measures of balance and physical function in older adults with osteoarthritis ( OA ) . DESIGN R and omized controlled trial . SETTING Community . PARTICIPANTS Persons ( N=39 ; mean±SD age , 74±6y ; 26 women ) with mild to moderate OA and at risk for falling met study criteria , were measured at baseline , and were r and omly assigned to the intervention ( n=23 ) and control groups ( n=16 ) . INTERVENTIONS Water-based program ( 12wk , twice weekly ; intervention group ) or a time-matched computer training program ( control group ) . MAIN OUTCOME MEASURE The primary outcome was the short-form Physiological Profile Assessment ( PPA ) . Secondary outcomes included the Step Test , Timed Up and Go Test , Western Ontario and McMaster Universities OA Index ( Likert 3.0 version ) , Arthritis Impact Measurement Scales 2 , and Activity-specific Balance Confidence Scale . RESULTS No statistically significant between-group differences were found for any outcome measured ( n=35 ; 4 lost to follow-up ) . Within-group analysis indicated that Step Test results improved significantly in both groups ( mean change : control group , left leg , 2.07 ; 95 % confidence interval , 3.19-.95 ; P=.002 ; intervention group , 2.14 ; 95 % confidence interval , 3.20 - 1.08 ; P=.000 ) . Two PPA item scores ( reaction time , contrast sensitivity ) improved significantly ( 86.83 ; 95 % confidence interval , 9.86 - 163.79 ; P=.03 ; 1.43 ; 95 % confidence interval , 2.35-.50 ; P=.005 , respectively ) in the control group , result ing in a lower falls risk score . CONCLUSIONS Water-based exercise did not reduce falls risk in our sample compared with attending a computer skills training class . Our study is , to our knowledge , the first to compare water-based exercise in this population with a control group that attended a time-dose-equivalent seated community-based activity . Whether gaining computer skills and going out into the community twice weekly is adequate stimulus to reduce falls risk in people with OA requires further investigation",
"OBJECTIVE To design an aquatic exercise ( AQE ) and l and -based exercise ( LBE ) program to enhance knee function and reduce body fat in patients with obesity and knee osteoarthritis and to investigate the effectiveness of AQE and LBE on body fat , functional fitness , and functional status . SETTING Outpatient clinic at a Seoul National University Bundang Hospital . PARTICIPANTS Obese patients with knee osteoarthritis were recruited from patients who visited the rehabilitation , orthopedic surgery , and geriatric outpatient clinics at the hospital . Study participants were limited to those who met the following criteria : body mass index more than 25 kg/m(2 ) , abdominal circumference more than 90 cm ( men ) or 85 cm ( women ) , clinical ly diagnosed osteoarthritis with Kellgren-Lawrence scale 2 or higher on radiographic studies , and independent ambulation state . METHODS Participants were r and omly allocated into 3 groups : AQE ( n = 26 ) , LBE ( n = 25 ) , and the control group ( n = 24 ) . Exercise interventions were conducted 3 times a week for 8 weeks . OUTCOME MEASURES Body fat analysis , brief pain inventory , Western Ontario and McMaster Universities ' osteoarthritis index , Short Form-36 question naire , and knee isokinetic tests were evaluated to assess changes in body fat composition , pain , physical function , and quality of life before and after the exercise program . RESULTS Although no significant difference was found in general characteristics among the 3 groups before exercise , body fat proportion in the AQE group decreased significantly ( mean + /- SD , from 34.4 + /- 4.7 to 33.3 + /- 4.7 ; P = .031 ) after intervention . The body mass index was slightly reduced after intervention , but it was not statistically significant . The AQE group showed significant improvements in pain , disability , and quality of life . Notably , the change in pain interference in the AQE group ( mean + /- SD , from 25.8 + /- 15.1 to 18.8 + /- 13.1 ; P = .009 ) was greater than that of the LBE group . Both exercise groups showed significant improvements in Western Ontario and McMaster Universities ' osteoarthritis index disability compared with the control group . CONCLUSIONS AQE had an advantage in controlling the interference with activity because of pain . AQE may be an effective tool for patients with obesity who have difficulties with active exercise due to knee osteoarthritis"
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41182a2a-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE To systematic ally review the evidence examining effects of walking interventions on pain and self-reported function in individuals with chronic musculoskeletal pain . DATA SOURCES Six electronic data bases ( MEDLINE , CINAHL , PsychINFO , PEDro , Sport Discus , and the Cochrane Central Register of Controlled Trials ) were search ed from January 1980 to March 2014 . STUDY SELECTION R and omized and quasi-r and omized controlled trials in adults with chronic low back pain , osteoarthritis , or fibromyalgia comparing walking interventions to a nonexercise or nonwalking exercise control group . DATA EXTRACTION Data were independently extracted using a st and ardized form . Method ological quality was assessed using the U.S. Preventive Services Task Force system . DATA SYNTHESIS Twenty-six studies ( 2384 participants ) were included , and suitable data from 17 studies were pooled for meta- analysis , with a r and om effects model used to calculate between-group mean differences and 95 % confidence intervals ( CIs ) . Data were analyzed according to the duration of follow-up ( short-term , ≤8wk postr and omization ; medium-term , > 2mo to 12mo ; long-term , > 12mo ) . Interventions were associated with small to moderate improvements in pain at short-term ( mean difference , -5.31 ; 95 % CI , -8.06 to -2.56 ) and medium-term ( mean difference , -7.92 ; 95 % CI , -12.37 to -3.48 ) follow-up . Improvements in function were observed at short-term ( mean difference , -6.47 ; 95 % CI , -12.00 to -0.95 ) , medium-term ( mean difference , -9.31 ; 95 % CI , -14.00 to -4.61 ) , and long-term ( mean difference , -5.22 ; 95 % CI , -7.21 to -3.23 ) follow-up . CONCLUSIONS Evidence of fair method ological quality suggests that walking is associated with significant improvements in outcome compared with control interventions but longer-term effectiveness is uncertain . With the use of the U.S. Preventive Services Task Force system , walking can be recommended as an effective form of exercise or activity for individuals with chronic musculoskeletal pain but should be supplemented with strategies aim ed at maintaining participation . Further work is required for examining effects on important health-related outcomes in this population in robustly design ed studies
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"The purpose of this study was to compare the effects of aerobic training with a muscle-strengthening program in patients with fibromyalgia . Thirty women with fibromyalgia were r and omized to either an aerobic exercise ( AE ) program or a strengthening exercise ( SE ) program for 8 weeks . Outcome measures included the intensity of fibromyalgia-related symptoms , tender point count , fitness ( 6-min walk distance ) , hospital anxiety and depression ( HAD ) scale , and short-form health survey ( SF-36 ) . There were significant improvements in both groups regarding pain , sleep , fatigue , tender point count , and fitness after treatment . HAD-depression scores improved significantly in both groups while no significant change occurred in HAD-anxiety scores . Bodily pain subscale of SF-36 and physical component summary improved significantly in the AE group , whereas seven subscales of SF-36 , physical component summary , and mental component summary improved significantly in the SE group . When the groups were compared after treatment , there were no significant differences in pain , sleep , fatigue , tender point count , fitness , HAD scores , and SF-36 scores . AE and SE are similarly effective at improving symptoms , tender point count , fitness , depression , and quality of life in fibromyalgia",
"Background Active approaches including both specific and unspecific exercise are probably the most widely recommended treatment for patients with chronic low back pain but it is not known exactly which types of exercise provide the most benefit . Nordic Walking - power walking using ski poles - is a popular and fast growing type of exercise in Northern Europe that has been shown to improve cardiovascular metabolism . Until now , no studies have been performed to investigate whether Nordic Walking has beneficial effects in relation to back pain . Methods A total of 151 patients with low back and /or leg pain of greater than eight weeks duration were recruited from a hospital based outpatient back pain clinic . Patients continuing to have pain greater than three on the 11-point numeric rating scale after a multidisciplinary intervention were included . Fifteen patients were unable to complete the baseline evaluation and 136 patients were r and omized to receive A ) Nordic walking supervised by a specially trained instructor twice a week for eight weeks B ) One-hour instruction in Nordic walking by a specially trained instructor followed by advice to perform Nordic walking at home as much as they liked for eight weeks or C ) Individual oral information consisting of advice to remain active and about maintaining the daily function level that they had achieved during their stay at the backcenter . Primary outcome measures were pain and disability using the Low Back Pain Rating Scale , and functional limitation further assessed using the Patient Specific Function Scale . Furthermore , information on time off work , use of medication , and concurrent treatment for their low back pain was collected . Objective measurements of physical activity levels for the supervised and unsupervised Nordic walking groups were performed using accelerometers . Data were analyzed on an intention-to-treat basis . Results No mean differences were found between the three groups in relation to any of the outcomes at baseline . For pain , disability , and patient specific function the supervised Nordic walking group generally faired best however no statistically significant differences were found . Regarding the secondary outcome measures , patients in the supervised group tended to use less pain medication , to seek less concurrent care for their back pain , at the eight-week follow-up . There was no difference between physical activity levels for the supervised and unsupervised Nordic walking groups . No negative side effects were reported . Conclusion We did not find statistically significant differences between eight weeks of supervised or unsupervised Nordic walking and advice to remain active in a group of chronic low back pain patients . Nevertheless , the greatest average improvement tended to favor the supervised Nordic walking group and - taking into account other health related benefits of Nordic walking - this form of exercise may potentially be of benefit to selected groups of chronic back pain patients .Trial registration http://www . Clinical Trials.gov #",
"Objectives : To assess the effectiveness of multidisciplinary rehabilitation in the treatment of fibromyalgia in comparison to st and ard medical care . Methods : Seventy-nine men and women were r and omly assigned to one of two groups . The intervention group consisted of a rheumatologist and physical therapist intake and discharge , 18 group supervised exercise therapy sessions , 2 group pain and stress management lectures , 1 group education lecture , 1 group dietary lecture , and 2 massage therapy sessions . The control group consisted of st and ard medical care with the patients ' family physician . Outcome measures included self-perceived health status , pain-related disability , average pain intensity , depressed mood , days in pain , hours in pain , prescription and nonprescription medication usage , and work status . Outcomes were measured at the end of the 6-week intervention and at 15-month follow-up . Results : Thirty-five out of 43 patients from the intervention group and 36 out of 36 patients from the control group completed the study . There were no statistically significant differences between the 2 groups prior to intervention . Intention-to-treat analysis revealed that the intervention group , in comparison to the control group , experienced statistically significant changes at intervention completion in self-perceived health status , average pain intensity , pain related disability , depressed mood , days in pain , and hours in pain , but no significant differences in nonprescription drug use , prescription drug use , or work status . At 15 months , all health outcomes retained their significance except health status . Nonprescription and prescription drug use demonstrated significant reductions at 15 months . Binary logistic regression indicated that long-term changes in Pain Disability Index were influenced by long-term exercise adherence and income status . Conclusions : Positive health-related outcomes in this mostly unresponsive condition can be obtained with a low-cost , group multidisciplinary intervention in a community-based , non clinical setting",
"Objectives : To evaluate the feasibility of an RCT of a pedometer-driven walking program and education/advice to remain active compared with education/advice only for treatment of chronic low back pain ( CLBP ) . Methods : Fifty-seven participants with CLBP recruited from primary care were r and omly allocated to either : ( 1 ) education/advice ( E , n=17 ) or ( 2 ) education/advice plus an 8-week pedometer-driven walking program ( EWP , n=40 ) . Step targets , actual daily step counts , and adverse events were recorded in a walking diary over the 8 weeks of intervention for the EWP group only . All other outcomes ( eg , functional disability using the Oswestry Disability Question naire ( ODQ ) , pain scores , physical activity ( PA ) measurement etc . ) were recorded at baseline , week 9 ( immediately post-intervention ) , and 6 months in both groups . Results : The recruitment rate was 22 % and the dropout rate was lower than anticipated ( 13 % to 18 % at 6 mo ) . Adherence with the EWP was high , 93 % ( n=37/40 ) walked for ≥6 weeks , and increased their steps/day ( mean absolute increase in steps/d , 2776 , 95 % confidence interval [ CI ] , 1996 - 3557 ) by 59 % ( 95 % CI , 40.73%-76.25 % ) from baseline . Mean percentage adherence with weekly step targets was 70 % ( 95 % CI , 62%-77 % ) . Eight ( 20 % ) minor-related adverse events were observed in 13 % ( 5/40 ) of the participants . The EWP group participants demonstrated an 8.2 % point improvement ( 95 % CI , −13 to −3.4 ) on the ODQ at 6 months compared with 1.6 % points ( 95 % CI , –9.3 to 6.1 ) for the E group ( between group d=0.44 ) . There was also a larger mean improvement in pain ( d=0.4 ) and a larger increase in PA ( d=0.59 ) at 6 months in EWP . Discussion : This preliminary study demonstrated that a main RCT is feasible . EWP was safe and produced a real increase in walking ; CLBP function and pain improved , and participants perceived a greater improvement in their PA levels . These improvements require confirmation in a fully powered RCT",
"OBJECTIVE The Arthritis , Diet , and Activity Promotion Trial ( ADAPT ) was a r and omized , single-blind clinical trial lasting 18 months that was design ed to determine whether long-term exercise and dietary weight loss are more effective , either separately or in combination , than usual care in improving physical function , pain , and mobility in older overweight and obese adults with knee osteoarthritis ( OA ) . METHODS Three hundred sixteen community-dwelling overweight and obese adults ages 60 years and older , with a body mass index of > or = 28 kg/m(2 ) , knee pain , radiographic evidence of knee OA , and self-reported physical disability , were r and omized into healthy lifestyle ( control ) , diet only , exercise only , and diet plus exercise groups . The primary outcome was self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . Secondary outcomes included weight loss , 6-minute walk distance , stair-climb time , WOMAC pain and stiffness scores , and joint space width . RESULTS Of the 316 r and omized participants , 252 ( 80 % ) completed the study . Adherence was as follows : for healthy lifestyle , 73 % ; for diet only , 72 % ; for exercise only , 60 % ; and for diet plus exercise , 64 % . In the diet plus exercise group , significant improvements in self-reported physical function ( P 6-minute walk distance ( P stair-climb time ( P knee pain ( P 6-minute walk distance ( P . The weight-loss groups lost significantly ( P body weight ( for diet , 4.9 % ; for diet plus exercise , 5.7 % ) than did the healthy lifestyle group ( 1.2 % ) . Finally , changes in joint space width were not different between the groups . CONCLUSION The combination of modest weight loss plus moderate exercise provides better overall improvements in self-reported measures of function and pain and in performance measures of mobility in older overweight and obese adults with knee OA compared with either intervention alone",
"OBJECTIVE Walking exercise alleviates some symptoms , such as pain , in patients with mild to moderate knee osteoarthritis ( OA ) . However , a major concern is that weightbearing exercise on osteoarthritic joints may exacerbate articular cartilage degradation . Loading of proteoglycan depleted articular cartilage in vitro increased expression of the chondroitin sulphate epitope 3B3 , suggesting that loading may influence metabolism of osteoarthritic cartilage . This study aim ed at evaluating the effects of walking exercise on articular cartilage metabolism in patients with knee OA , as reflected by changes in concentrations of synovial fluid markers . METHODS Thirty elderly patients with knee OA ( Kellgren-Lawrence grade s II to IV ) were r and omly allocated to control ( n = 15 ) and 12 week exercise ( n = 15 ) groups . Synovial fluid obtained from 21 of the patients at time zero and after 12 weeks was examined by enzyme linked immunosorbent assay ( ELISA ) for the chondroitin sulphate epitopes 3B3 and 7D4 , and by a dye binding assay with 1,9-dimethylmethylene blue for total sulphated glycosaminoglycan ( GAG ) concentrations . The 3B3/GAG and 7D4/GAG ratios were calculated . RESULTS No significant changes in concentrations of 3B3 , 7D4 , GAG , 3B3/GAG , or 7D4/GAG between time zero and 12 weeks were found in either group . However , there were significant declines in 3B3 ( p=0.001 ) , GAG ( p=0.007 ) , and the 3B3/GAG ratio ( p=0.049 ) with aging . CONCLUSION Twelve weeks of walking exercise had no demonstrable adverse effects on articular cartilage metabolism , as reflected by the concentrations of synovial fluid GAG or the chondroitin sulphate epitopes 3B3 and 7D4",
"OBJECTIVE To compare 2 exercise modalities , aerobic fitness training and stretching exercises , in patients with fibromyalgia ( FM ) in relation to function , pain , quality of life , depression , and anxiety , and to correlate the cardiorespiratory fitness gain with symptom improvement . METHODS Seventy-six women with FM between 18 and 60 years old were r and omized to either an aerobic program or stretching program , for 20 weeks . They were evaluated at the beginning of the program and after 10 and 20 weeks in relation to the improvement of aerobic fitness , flexibility , function , Fibromyalgia Impact Question naire ( FIQ ) , Short-form Health Survey ( SF-36 ) , and depression and anxiety levels . Ventilatory anaerobic threshold ( VT ) and maximum oxygen uptake ( VO2max ) were determined by expired gas analyses . RESULTS Aerobic exercise was superior to stretching in relation to VO2 max , VT , function , depression , pain , and the emotional aspects and mental health domains of SF-36 . Patients in the stretching group showed no improvement in depression , \" role emotional , \" and \" mental health . \" No association was noted between improvement in aerobic fitness as measured by VT and the improvement of pain , function , or scores in FIQ and SF-36 . CONCLUSION Our results confirm that aerobic exercise is beneficial to patients with FM , but the cardiorespiratory fitness gain is not related to improvement of FM symptoms",
"OBJECTIVE To assess the utility of an exercise program , which included aerobic , flexibility and strengthening elements , in the treatment of fibromyalgia ( FM ) . FM is a chronic musculoskeletal condition characterized by diffuse musculoskeletal pain and aching . It has been suggested that aerobic exercise is helpful in its treatment . METHODS We studied 60 patients who met American College of Rheumatology criteria for FM and had no significant comorbidities . Measurements performed on each patient at the pre and post study assessment included the number of tender points ( TP ) , total myalgic scores ( TM ) , aerobic fitness ( AF ) , flexibility and isokinetic strength . After initial evaluation patients were r and omly assigned to either an exercise or a relaxation group . Each group met 3 times per week for 6 weeks for 1 h of supervised exercise or relaxation . All patients data were stored in a computerized data base and statistical analysis was performed on all pre and post study assessment s. RESULTS Thirty-eight patients ( 18 exercise and 20 relaxation ) completed the study . Analysis of our data showed no significant difference between the groups in their pre study assessment . Post study assessment s , however , showed a significant improvement between the exercise and relaxation groups in TP ( p TM ( p AF ( p Exercise is helpful in the management of FM in the short term . It also shows that FM patients can undertake an exercise program which includes aerobic , flexibility , and strength training exercises without adverse effects . The long term utility of this type of exercise requires further evaluation",
"Background Chronic pain , especially back pain , is a prevalent condition that is associated with disability , poor health status , anxiety and depression , decreased quality of life , and increased health services use and costs . Current evidence suggests that exercise is an effective strategy for managing chronic pain . However , there are few clinical programs that use generally available tools and a relatively low-cost approach to help patients with chronic back pain initiate and maintain an exercise program . Objective The objective of the study was to determine whether a pedometer-based , Internet-mediated intervention can reduce chronic back pain-related disability . Methods A parallel group r and omized controlled trial was conducted with 1:1 allocation to the intervention or usual care group . 229 veterans with nonspecific chronic back pain were recruited from one Department of Veterans Affairs ( VA ) health care system . Participants r and omized to the intervention received an uploading pedometer and had access to a website that provided automated walking goals , feedback , motivational messages , and social support through an e-community ( n=111 ) . Usual care participants ( n=118 ) also received the uploading pedometer but did not receive the automated feedback or have access to the website . The primary outcome was measured using the Rol and Morris Disability Question naire ( RDQ ) at 6 months ( secondary ) and 12 months ( primary ) with a difference in mean scores of at least 2 considered clinical ly meaningful . Both a complete case and all case analysis , using linear mixed effects models , were conducted to assess differences between study groups at both time points . Results Baseline mean RDQ scores were greater than 9 in both groups . Primary outcome data were provided by approximately 90 % of intervention and usual care participants at both 6 and 12 months . At 6 months , average RDQ scores were 7.2 for intervention participants compared to 9.2 for usual care , an adjusted difference of 1.6 ( 95 % CI 0.3 - 2.8 , P=.02 ) for the complete case analysis and 1.2 ( 95 % CI -0.09 to 2.5 , P=.07 ) for the all case analysis . A post hoc analysis of patients with baseline RDQ scores ≥4 revealed even larger adjusted differences between groups at 6 months but at 12 months the differences were no longer statistically significant . Conclusions Intervention participants , compared with those receiving usual care , reported a greater decrease in back pain-related disability in the 6 months following study enrollment . Between-group differences were especially prominent for patients reporting greater baseline levels of disability but did not persist over 12 months . Primarily , automated interventions may be an efficient way to assist patients with managing chronic back pain ; additional support may be needed to ensure continuing improvements . Trial Registration Clinical Trials.gov NCT00694018 ; http:// clinical trials.gov/ct2/show/NCT00694018 ( Archived by WebCite at http://www.webcitation.org/6IsG4Y90E )",
"We conducted a pilot study to evaluate a practical exercise program for elderly people with chronic musculo-skeletal pain . Thirty-three subjects ( mean age , 73 years ; 69 % back pain ; 24 % knee pain ; 9 % hip pain ) were r and omly assigned to one of three groups . Group 1 received a 6-week supervised program of walking . Group 2 received a pain education program that included instruction and demonstration of use of heat , cold , massage , relaxation and distraction . Group 3 received usual care . Outcomes including pain , self-reported health and functional status , and performance-based measures of functional status were evaluated at baseline , at two weeks and at eight weeks ( end of study ) . Attendance was 100 % for the education sessions and 93 % for walking sessions . No injuries were sustained . Both intervention groups demonstrated significant improvements in pain ( p performance-based measures of functional status ( p patient education and fitness walking can improve overall pain management and related functional limitations among elderly people with chronic musculo-skeletal pain",
"Background Osteoarthritis ( OA ) is the most common joint disorder in the world , as it is appears to be prevalent among 80 % of individuals over the age of 75 . Although physical activities such as walking have been scientifically proven to improve physical function and arthritic symptoms , individuals with OA tend to adopt a sedentary lifestyle . There is therefore a need to improve knowledge translation in order to influence individuals to adopt effective self-management interventions , such as an adapted walking program . Methods A single-blind , r and omized control trial was conducted . Subjects ( n = 222 ) were r and omized to one of three knowledge translation groups : 1 ) Walking and Behavioural intervention ( WB ) ( 18 males , 57 females ) which included the supervised community-based aerobic walking program combined with a behavioural intervention and an educational pamphlet on the benefits of walking ; 2 ) Walking intervention ( W ) ( 24 males , 57 females ) wherein participants only received the supervised community-based aerobic walking program intervention and the educational pamphlet ; 3 ) Self-directed control ( C ) ( 32 males , 52 females ) wherein participants only received the educational pamphlet . One-way analyses of variance were used to test for differences in quality of life , adherence , confidence , and clinical outcomes among the study groups at each 3 month assessment during the 12-month intervention period and 6-month follow-up period . Results The clinical and quality of life outcomes improved among participants in each of the three comparative groups . However , there were few statistically significant differences observed for quality of life and clinical outcomes at long-term measurements at 12-months end of intervention and at 6- months post intervention ( 18-month follow-up ) . Outcome results varied among the three groups . Conclusion The three groups were equivalent when determining the effectiveness of knowledge uptake and improvements in quality of life and other clinical outcomes . OA can be managed through the implementation of a proven effective walking program in existing community-based walking clubs . Trial registration Current Controlled Trials",
"Objective : To investigate whether a four-week walking exercise programme in patients with knee osteoarthritis improves the ability of dual-task performance in older adults with knee osteoarthritis . Design : A r and omized controlled trial with two groups : a walking group and a control group . Subjects : Forty older adults with knee osteoarthritis , 20 participants in each group . Intervention : The walking intervention was design ed to increase the number of steps walked daily . The walking group was instructed to increase their number of steps to 3000 steps more than before the intervention . Main outcome measures : Dual-task performance was computed by an automaticity index : the walking velocity under single-task condition/under dual-task conditions × 100 ( % ) , defined as automaticity . The nearer to 100 % automaticity , the better the dual-task performance . Decrease of the Trail Making Test ( TMT ) performance was defined as ΔTMT . ΔTMT was calculated as the difference between times ( part B – part A ) as a measure of executive function . In addition , functional ability was measured by the Japanese Knee Osteoarthritis Measure . Results : The walking group improved significantly in automaticity ( P ( 10.4 ) , ΔTMT ( P ) and Japanese Knee Osteoarthritis Measure score ( P found that walking exercise improves executive function and dual-task performance ",
"Objective To examine the association between physical activity-related injuries and participation in walking versus running . Design Nested case-control study . Setting Cooper Clinic Preventive Medicine Center , Dallas , Texas . Participants 5,327 men and women undergoing exams between 1987 and 1995 and completing follow-up health history question naires in 1990 or 1995 . Participants were classified as those reporting regular participation in walking or jogging/running at baseline . Those reporting both or neither activity were excluded from the study ( n = 1404 ) . Cases ( 698 men , 169 women ) were those reporting physical activity-related injuries requiring physician visits in the previous year on the follow-up question naire . Controls ( 2,358 men , 698 women ) were r and omly selected from the remaining population . Main Outcome Measures Logistic regression was used to examine the risk of injury in walkers versus runners and risk of injury by exercise dose while considering age , body mass index , previous injury , and strength training . Results There was a significantly lower risk of injury for walkers compared with runners in young ( greater amounts of walking on injuries for either gender ; however , there was a higher injury risk associated with running 15–30 min/day ( OR = 1.36 , 95 % CI = 1.07–1.73 ) and 30 + min/day ( OR = 1.52 , 95 % CI = 1.14–2.04 ) compared with participation in walking can be safely recommended as a way to improve health and fitness",
"BACKGROUND Self-management has increasingly been recommended as part of st and ard care for fibromyalgia , a common , poorly understood condition with limited treatment options . Data that assess popular self-management recommendations are scarce . We evaluated and compared the effectiveness of 4 common self-management treatments on function , symptoms , and self-efficacy in women with fibromyalgia . METHODS A total of 207 women with confirmed fibromyalgia were recruited from September 16 , 2002 , through November 30 , 2004 , and r and omly assigned to 16 weeks of ( 1 ) aerobic and flexibility exercise ( AE ) ; ( 2 ) strength training , aerobic , and flexibility exercise ( ST ) ; ( 3 ) the Fibromyalgia Self-Help Course ( FSHC ) ; or ( 4 ) a combination of ST and FSHC ( ST-FSHC ) . The primary outcome was change in physical function from baseline to completion of the intervention . Secondary outcomes included social and emotional function , symptoms , and self-efficacy . RESULTS Improvements in the mean Fibromyalgia Impact Question naire score in the 4 groups were -12.7 for the ST-FSHC group , -8.2 for the AE group , -6.6 for the ST group , and -0.3 for the FSHC group . The ST-FSHC group demonstrated greater improvement than the FSHC group ( mean difference , -12.4 ; 95 % confidence interval [ CI ] , -23.1 to -1.7 ) . The ST-FSHC ( mean difference , 13.6 ; 95 % CI , 2.3 to 24.9 ) and AE ( mean difference , 13.1 ; 95 % CI , 1.6 to 25.6 ) groups had similar improvements in physical function scores on the 36-Item Short-Form Health Survey . Bodily pain scores on the 36-Item Short-Form Health Survey improved in the ST-FSHC ( 14.8 ) , AE ( 13.2 ) , and ST ( 5.7 ) groups . Social function , mental health , fatigue , depression , and self-efficacy also improved . The beneficial effect on physical function of exercise alone and in combination with education persisted at 6 months . CONCLUSIONS Progressive walking , simple strength training movements , and stretching activities improve functional status , key symptoms , and self-efficacy in women with fibromyalgia actively being treated with medication . The benefits of exercise are enhanced when combined with targeted self-management education . Our findings suggest that appropriate exercise and patient education be included in the treatment of fibromyalgia",
"Abstract . Osteoarthritis ( OA ) of the knee is a very common rheumatological disease , and there are various treatment modalities for it . The aim of this study was to investigate the effects of home-based exercise and walking programs in the treatment of OA . A total of 90 patients with knee osteoarthritis were included . Their ages ranged between 48 and 71 years . The patients were separated into three groups . None of them had practice d a daily simple exercise program during the previous year . Group 1 ( n=30 ) was given a home-based exercise program . Group 2 ( n=30 ) had regular a walking program three times per week , starting with 10-min duration . Group 3 ( n=30 ) was accepted as the control group . Patients were assessed according to pain , functional capacity , and quality of life parameters . Pain was evaluated by the Western Ontario McMaster osteoarthritis index ( WOMAC ) of pain score and visual analogue scale ( VAS ) . Functional capacity was measured by WOMAC physical function index . Quality of life was assessed by the Nottingham Health Profile question naire ( NHP ) . All groups continued the program for 3 months . At the end of the therapy , the patients were called and 81 were accepted to come to the hospital . Although WOMAC pain and physical functional scores and VAS scores were statistically lower in both groups than in the control group ( P0.05 ) . But the result of the NHP showed a statistically significant improvement in the walking group when compared to the home-based exercise and control groups ( P home-based exercise therapy and a regular walking program are effective in treating the symptoms of OA",
"BACKGROUND AND PURPOSE The knee is the weight-bearing joint most commonly affected by osteoarthritis ( OA ) . The symptoms of pain , morning stiffness of short duration and physical dysfunction in the activities of daily living ( ADL ) can have an effect on many aspects of health , affecting quality of life . Regular and moderate physical activity adapted to individuals ' life-styles and education , and joint protection strategies have been advocated as conservative management . The purpose of the present study was to assess the impact of an exercise and walking protocol on the quality of life of elderly people with knee OA . METHOD The study design was a r and omized controlled clinical trial . The subjects comprised 50 elderly people , aged 65 or more , with knee OA who had been referred to the geriatric outpatient unit for rehabilitation . Changes in severity of pain and quality of life were compared between a control group ( CG ) and an experimental group ( EG ) . Both groups participated in an educational session and the EG also received a 12-week exercise and walking protocol . Both groups were assessed at baseline and after three and six months by an independent observer . The Lequesne Index of Knee OA Severity ( LI ) , the Health Assessment Question naire ( HAQ ) and the Medical Outcomes Short-Form Health Survey ( SF-36 ) were used as measurement instruments . RESULTS In the CG , the measures of quality of life ( SF-36 ) , the HAQ and the LI between subjects did not yield statistically significant differences over the three measurement points . For the EG , there was a significant improvement in function , measured by HAQ , and decreasing OA symptom severity , measured by LI . For the SF-36 there were significant improvements in physical function , functional role limitation and pain . Comparisons between the groups showed statistically significant differences after three and six months for all measures , except for the SF-36 emotional domains . CONCLUSION The exercise protocol and walking programme had a positive effect on the quality of life of elderly individuals with knee OA",
"OBJECTIVE To determine the effects of structured exercise programs on self-reported disability in older adults with knee osteoarthritis . SETTING AND DESIGN A r and omized , single-blind clinical trial lasting 18 months conducted at 2 academic medical centers . PARTICIPANTS A total of 439 community-dwelling adults , aged 60 years or older , with radiographically evident knee osteoarthritis , pain , and self-reported physical disability . INTERVENTIONS An aerobic exercise program , a resistance exercise program , and a health education program . MAIN OUTCOME MEASURES The primary outcome was self-reported disability score ( range , 1 - 5 ) . The secondary outcomes were knee pain score ( range , 1 - 6 ) , performance measures of physical function , x-ray score , aerobic capacity , and knee muscle strength . RESULTS A total of 365 ( 83 % ) participants completed the trial . Overall compliance with the exercise prescription was 68 % in the aerobic training group and 70 % in the resistance training group . Postr and omization , participants in the aerobic exercise group had a 10 % lower adjusted mean ( + /- SE ) score on the physical disability question naire ( 1.71 + /- 0.03 vs 1.90 + /- 0.04 units ; P knee pain question naire ( 2.1 + /- 0.05 vs 2.4 + /- 0.05 units ; P=.001 ) , and performed better ( mean [ + /- SE ] ) on the 6-minute walk test ( 1507 + /- 16 vs 1349 + /- 16 ft ; P time to climb and descend stairs ( 12.7 + /- 0.4 vs 13.9 + /- 0.4 seconds ; P=.05 ) , time to lift and carry 10 pounds ( 9.1 + /- 0.2 vs 10.0 + /- 0.1 seconds ; P time to get in and out of a car ( 8.7 + /- 0.3 vs 10.6 + /- 0.3 seconds ; P resistance exercise group had an 8 % lower score on the physical disability question naire ( 1.74 + /- 0.04 vs 1.90 + /- 0.03 units ; P=.003 ) , 8 % lower pain score ( 2.2 + /- 0.06 vs 2.4 + /- 0.05 units ; P=.02 ) , greater distance on the 6-minute walk ( 1406 + /- 17 vs 1349 + /- 16 ft ; P=.02 ) , faster times on the lifting and carrying task ( 9.3 + /- 0.1 vs 10.0 + /- 0.16 seconds ; P=.001 ) , and the car task ( 9.0 + /- 0.3 vs 10.6 + /- 0.3 seconds ; P=.003 ) than the health education group . There were no differences in x-ray scores between either exercise group and the health education group . CONCLUSIONS Older disabled persons with osteoarthritis of the knee had modest improvements in measures of disability , physical performance , and pain from participating in either an aerobic or a resistance exercise program . These data suggest that exercise should be prescribed as part of the treatment for knee osteoarthritis",
"OBJECTIVES To determine whether a home-based pedometer-driven walking program with arthritis self-management education ( Walk + ) would increase physical activity , muscle strength , and functional performance in older adults with osteoarthritis ( OA ) of the knee as opposed to arthritis self-management education alone ( EDU ) . DESIGN A r and omized two-by-three ( group-by-time ) design with participants assigned to Walk + ( n = 17 , mean age + /- st and ard deviation = 69.6 + /- 6.7 ) or EDU ( n = 17 , age = 70.8 + /- 4.7 ) . SETTING Community located in the Baltimore-Washington area . PARTICIPANTS Thirty-four community-dwelling adults , aged 60 and older with symptomatic knee OA and self-reported functional impairment . INTERVENTIONS Both groups received 12 hours of the Arthritis Self-Management program over 12 weeks and were followed for an additional 12 weeks . In addition , the Walk + group received individualized instruction in the use of a pedometer , with the goal of increasing their step count by 30 % of their baseline step count . MEASUREMENTS The outcome measures were physical activity ( daily step counts and total activity vector magnitude as measured by a pedometer and Tritrac-R3D accelerometer ) , quadriceps femoris strength ( isometric peak torque ) , and functional performance tasks ( 100-foot walk-turn-walk , timed stair climb , timed chair rise , and pain status ) . RESULTS Daily steps walked showed a significant group-by-time interaction ( P = .04 ) after controlling for age . From baseline to completion of training , a 23 % increase in daily steps occurred in the Walk + group and a 15 % decrease in the EDU group . Although steps increased in the Walk + group , total activity vector magnitude was maintained , suggesting a more efficient gait . The Walk + group became quicker than the EDU group in the normal-pace walk-turn-walk ( P = .04 ) . An isometric strength gain of 21 % postintervention was seen in the Walk + group , compared with a loss of 3.5 % in the EDU group . CONCLUSION In older adults with symptomatic knee OA , Walk + appears to increase walking , with improvements in muscle strength and walking performance . The use of a home-based pedometer-driven program to increase physical activity , strength , and function in this population warrants further research",
"OBJECTIVE To determine whether gains in functioning observed immediately following participation in an 8-week program of supervised fitness walking for patients with knee osteoarthritis were sustained at 1-year followup . METHODS Twenty-nine ( 61.1 % ) of 47 original intervention program patients and 23 ( 51.1 % ) of 45 original control patients were interviewed by telephone at 1-year followup . Patients completed the Arthritis Impact Measurement Scales physical activity , arthritis impact , pain , medication use , and general health perceptions subscales , as well as a separate visual analog pain scale and measures of perceived self-efficacy to cope with arthritis pain and other symptoms . RESULTS Adherence to walking was low , and there were no statistically significant differences between intervention and control patients at one year . CONCLUSIONS The failure of intervention patients to maintain regular walking result ed in loss of functional benefits that were observed at 8 weeks in the original study . Long-term adherence to walking is critical to maintenance of initial gains in functional outcomes",
"UNLABELLED Fibromyalgia ( FM ) , a rheumatological disorder of unknown origin , is characterized by both physical and psychological symptoms . Although inconclusive results have been reported for most treatment modalities , exercise appears to have universal support for decreasing the myriad of symptoms associated with FM . Weaknesses in the literature , however , prevent conclusive statements regarding exercise prescription and concomitant impact on FM symptomology . PURPOSE The current pilot study attempted to examine the effect of a 24-wk walking program at predetermined intensities on FM . METHODS Initial design was a r and omized control trial with high- and low-intensity exercise groups , and a control group . Subsequent nonr and omized control trials were based on actual exercise behavior . RESULTS No differences between initial groups were identified . By collapsing groups , heart rate ( HR ) decreased ( P Functional impairments were reduced 54 % weeks 0 - 24 , with exercise having a large impact ( omega2 = 0.30 ) on this decrease . By reassigning groups , impact of FM on current health status decreased in the low-intensity group ( P influence of exercise on pain ( omega2 = 0.51 ) , with greater pain in the high-intensity group . CONCLUSIONS A larger number of subjects and direct supervision of the training program to increase compliance is necessary to clarify the effects of a walking program on the manifestations of FM . Results indicate that intensity of the walking program is an important consideration . Individuals with FM can adhere to low-intensity walking programs two to three times per week , possibly reducing FM impact on daily activities",
"OBJECTIVE Physical function and body composition in older obese adults with knee osteoarthritis ( OA ) were examined after intensive weight loss . RESEARCH METHODS AND PROCEDURES Older obese adults ( n = 87 ; > or = 60 years ; BMI > or = 30.0 kg/m2 ) with symptomatic knee OA and difficulty with daily activities were recruited for a 6-month trial . Participants were r and omized into either a weight stable ( WS ) or weight loss ( WL ) program . Participants in WL ( 10 % weight loss goal ) were prescribed a 1000 kcal/d energy deficit diet with exercise 3 d/wk . WS participants attended health information sessions . Body composition and physical function ( Western Ontario and McMaster University Osteoarthritis Index , 6-minute walking distance , and stair climb time ) were assessed at baseline and 6 months . Statistical analysis included univariate analysis of covariance on 6-month measurements using baseline values as covariates . Associations between physical function and body composition were performed . RESULTS Body weight decreased 8.7 + /- 0.8 % in WL and 0.0 + /- 0.7 % in WS . Body fat and fat-free mass were lower for WL than WS at 6 months ( estimated means : fat = 38.1 + /- 0.4 % vs. 40.9 + /- 0.4 % , respectively ; fat-free mass = 56.7 + /- 0.4 vs. 58.8 + /- 0.4 kg , respectively ) . WL had better function than WS , with lower Western Ontario and McMaster University Osteoarthritis Index scores , greater 6-minute walk distance , and faster stair climb time ( p Changes in function were associated with weight loss in the entire cohort . DISCUSSION An intensive weight loss intervention incorporating energy deficit diet and exercise training improves physical function in older obese adults with knee OA . Greater improvements in function were observed in those with the most weight loss",
"The major goal of the U.S. Preventive Services Task Force ( USPSTF ) is to provide clinicians and policymakers with a reliable and accurate source of evidence -based recommendations on a wide range of preventive services . To accomplish this goal , the USPSTF systematic ally review s the evidence concerning both the benefits and harms of widespread implementation of a preventive service . It then assesses the certainty of the evidence and the magnitude of the benefits and harms . On the basis of this assessment , the USPSTF assigns a letter grade to each preventive service signifying its recommendation about provision of the service ( Table 1 ) . Table 1 . U.S. Preventive Services Task Force Recommendation Grid * An important , but often challenging , step is determining the balance between benefits and harms to estimate net benefit ( that is , benefits minus harms ) . In this issue , the Task Force reports an up date to its recommendation for carotid artery stenosis screening ( 1 , 2 ) . Because carotid artery stenosis screening has both known benefits and harms , estimating net benefit was critical in the final USPSTF recommendation that clinicians not provide carotid artery stenosis screening in asymptomatic people ( recommendation letter grade D ) . Release of this recommendation provides an opportunity for the Task Force to up date and explain to a clinical audience the process by which it evaluates evidence , determines the certainty and magnitude of net benefit , and gives a letter grade to the recommendation . We will do this by considering 3 questions : 1 ) What evidence does the Task Force consider to estimate net benefit ? 2 ) How does the Task Force estimate the certainty of net benefit ? and 3 ) How does the Task Force estimate the magnitude of net benefit ? What Evidence Does the Task Force Consider to Estimate Net Benefit ? The overarching question that the Task Force seeks to answer for every preventive service is whether evidence suggests that provision of the service would improve health outcomes if implemented in a general primary care population . For screening topics , this st and ard could be met by a large r and omized , controlled trial ( RCT ) in a representative asymptomatic population with follow-up of all members of both the group invited for screening and the group not invited for screening . For example , the Multicentre Aneurysm Screening Study ( 3 ) was a population -based RCT of screening for abdominal aortic aneurysm in which 67800 asymptomatic men age 65 to 74 years in the United Kingdom were r and omly assigned to be invited or not to be invited for screening . Both groups were followed for a mean of 4.1 years , and abdominal aortic aneurysmrelated mortality and all-cause mortality were compared . No RCTs of carotid artery stenosis screening have been published ; however , RCTs comparing carotid endarterectomy to medical management of asymptomatic carotid artery stenosis are available . The distinction between RCTs that r and omly assign people to undergo screening versus RCTs that r and omly assign people known to have a condition to an intervention is important . In contrast to the latter , RCTs of screening take into account the false-positive and false-negative rates of the screening test , the possibility of adverse events from the test , the accuracy and potential for adverse events of any subsequent confirmatory diagnostic tests , and the inevitable failure to follow through on the test or any subsequent steps needed before the therapeutic intervention is delivered . In addition , conditions detected by screening may have different biological characteristics than those detected in other ways . The benefits of treating screened individuals , therefore , can not be assumed to be the same as those of treating symptomatic individuals . Screening trials directly answer a simple question important to the primary care setting : Does screening for a certain condition improve health outcomes ? Direct RCT evidence about screening is often unavailable , so the Task Force considers indirect evidence . To guide its selection of indirect evidence , the Task Force constructs a chain of evidence within an analytic framework . Figure 1 of the evidence up date ( 2 ) in this issue ( page 861 ) shows the analytic framework for the Task Force assessment of carotid artery stenosis screening . Each arrow in the framework defines a key question , and each key question represents a link in the chain of evidence . Rectangles in the framework represent the intermediate outcomes ( rounded corners ) or the health outcomes ( square corners ) ; ovals represent harms . To form an unbroken chain , evidence must support each link in the chain , thereby connecting the target population ( far left side of the framework ) to the improved health outcome ( far right side of the framework ) . For each key question , the body of pertinent literature is critically appraised , focusing on 6 questions ( Table 2 ) . The USPSTF will now describe its judgment about the evidence for each key question as convincing , adequate , or inadequate . Evidence may be considered convincing when derived from several high- quality studies with consistent , logical results that are generalizable to the U.S. primary care population and setting . Evidence may be deemed adequate when , on the basis of judgment , most but not all of these 6 questions are answered favorably . When evidence is conflicting or the studies are of poor quality individually or in aggregate , the evidence for a key question is considered inadequate . Inadequate evidence may create a critical gap in the evidence chain . Table 2 . Questions Considered by the U.S. Preventive Services Task Force for Evaluating Evidence Related Both to Key Questions and to the Overall Certainty of the Evidence of Net Benefit for the Preventive Service How Does the Task Force Estimate the Certainty of Net Benefit ? The next step in the Task Force process is to use the evidence from the key questions to assess whether there would be net benefit if the service were implemented . In 2001 , the USPSTF published an article that documented its systematic processes of evidence evaluation and recommendation development ( 4 ) . At that time , the Task Force 's overall assessment of evidence was described as good , fair , or poor . The Task Force realized that this rating seemed to apply only to how well studies were conducted and did not fully capture all of the issues that go into an overall assessment of the evidence about net benefit . To avoid confusion , the USPSTF has changed its terminology . Whereas individual study quality will continue to be characterized as good , fair , or poor , the term certainty will now be used to describe the Task Force 's assessment of the overall body of evidence about net benefit of a preventive service and the likelihood that the assessment is correct . Certainty will be determined by considering all 6 questions in Table 2 ; the judgment about certainty will be described as high , moderate , or low . In making its assessment of certainty about net benefit , the evaluation of the evidence from each key question plays a primary role . It is important to note that the Task Force makes recommendations for real-world medical practice in the United States and must determine to what extent the evidence for each key question even evidence from screening RCTs or treatment RCTs can be applied to the general primary care population . Frequently , studies are conducted in highly selected population s under special conditions . The Task Force must consider differences between the general primary care population and the population s studied in RCTs and make judgments about the likelihood of observing the same effect in actual practice . For carotid artery stenosis screening , the Task Force search ed for evidence about the true prevalence of high- grade carotid artery stenosis in the general population , the generalizability of treatment effectiveness estimates based on RCTs conducted in selected population s , and the complication rate from carotid endarterectomy in asymptomatic individuals if performed in nontrial setting s ( for example , community hospitals ) . It is also important to note that 1 of the key questions in the analytic framework refers to the potential harms of the preventive service . The Task Force considers the evidence about the benefits and harms of preventive services separately and equally . Data about harms are often obtained from observational studies because harms observed in RCTs may not be representative of those found in usual practice and because some harms are not completely measured and reported in RCTs . For example , the surgeons who enrolled patients in RCTs of carotid artery stenosis were selected on the basis of their low postoperative stroke and mortality rates . Widespread screening for carotid artery stenosis would invariably lead to surgical treatment provided in hospitals ( or by surgeons ) with higher rates of complications . The harms of screening for carotid artery stenosis , including the harms from carotid angiography to confirm the diagnosis of carotid artery stenosis in patients screening positive by carotid ultrasonography , were not captured in some treatment RCTs . Putting the body of evidence for all key questions together as a chain , the Task Force assesses the certainty of net benefit of a preventive service by asking the 6 major questions in Table 2 . The Task Force would rate a body of convincing evidence about the benefits of a service that , for example , derives from several RCTs of screening in which the estimate of benefits can be generalized to the general primary care population as high certainty ( Table 3 ) . The Task Force would rate a body of evidence that was not clearly applicable to general practice or has other defects in quality , research design , or consistency of studies as moderate certainty . Certainty is low when , for example , there are gaps in the evidence linking parts of the analytic framework , when evidence to determine the harms of treatment is unavailable , or",
"AIM To examine the impact of two different lifestyle programmes on cardiovascular health and glycaemic control among people with type 2 diabetes . METHODS A two-phase 24-week r and omized trial . During the first phase , participants were to increase daily steps using a pedometer . At week 12 , participants were r and omly allocated to either an enhanced lifestyle programme ( ELP ) targeting walking speed or a basic lifestyle programme ( BLP ) targeting total daily steps . Both programmes focused on increasing the intake of low glycaemic index foods but utilized different goal setting strategies . Clinical measurements were completed at baseline , week 12 and week 24 . Principal outcomes were change in resting pulse rate ( PR ) and glycated haemoglobin A1c ( A1c ) between week 12 and week 24 compared between groups using analysis of covariance . RESULTS Forty-one participants [ mean + /- s.d . : age = 56.5 + /- 7.2 years , body mass index ( BMI ) = 32.7 + /- 6.1 kg/m(2 ) ] were r and omized . After 12 weeks , we observed an increase in average total daily steps of 1688 ( 95 % confidence interval : 330 - 3040 , [ corrected ] p = 0.02 ) . Weight , BMI and systolic and diastolic blood pressure improved ( p energy intake . At week 24 , those in the ELP had a lower resting PR ( 71 + /- 12 b.p.m . ) compared with those in the BLP ( 78 + /- 12 b.p.m . ) ( adjusted p = 0.03 ) , while no group differences for total daily steps or glycaemic control were observed . CONCLUSIONS Improvements in cardiovascular health can be expected following a pedometer-based lifestyle modification programme that progresses from walking more to walking faster",
"Study Design . The study was a r and omized controlled trial . Treatment was for 8 weeks , with follow-up posttreatment and at 6- , 12- , and 36- months . Objective . The purpose was to evaluate the effect of a grade d exercise intervention emphasizing stabilizing exercises in patients with nonspecific , recurrent low back pain ( LBP ) . Summary of Background Data . Exercise therapy is recommended and widely used as treatment for LBP . Although stabilizing exercises are reportedly effective in the management of certain subgroups of LBP , such intervention protocol s have not yet been evaluated in relation to a more general exercise regimen in patients with recurrent LBP , all at work . Methods . Seventy-one patients recruited consecutively ( 36 men , 35 women ) with recurrent nonspecific LBP seeking care at an outpatient physiotherapy clinic were r and omized into 2 treatment groups ; grade d exercise intervention or daily walks . The primary outcome was perceived disability and pain at 12-month follow-up . Secondary outcomes included physical health , fear-avoidance , and self-efficacy beliefs . Results . Of the participants , 83 % provided data at the 12-month follow-up and 79 % at 36 months . At 12 months , between-group comparison showed a reduction in perceived disability in favor of the exercise group , whereas such an effect for pain emerged only immediately postintervention . Ratings of physical health and self-efficacy beliefs also improved in the exercise group over the long term , though no changes were observed for fear-avoidance beliefs . Conclusion . A grade d exercise intervention , emphasizing stabilizing exercises , for patients with recurrent LBP still at work seems more effective in improving disability and health parameters than daily walks do . However , no such positive results emerged for improvement regarding pain over a longer term , or for fear-avoidance beliefs",
"& NA ; Osteoarthritis of the knee , a prevalent condition in older adults , can impact physical function and ability to perform physical activity . This r and omized controlled trial examined the effects of a 6‐month self‐efficacy‐based , individually delivered , lower‐extremity exercise and fitness walking intervention with 6‐month follow‐up on physical activity and function . The 26 subjects were mostly older ( M = 63.2 years , SD = 9.8 ) , White ( 83 % ) , obese ( BMI M = 33.3 , SD = 6.0 ) women ( 96 % ) . Physical activity was measured by diaries . Physical function was measured by the 6‐minute walk , Short Physical Performance Battery ( SPPB ) , and WOMAC Physical Function subscale . Exercise self‐efficacy was assessed by a question naire . Results showed significant increases in self‐reported performance of lower‐extremity exercise and participation in fitness walking , distance in the 6‐minute walk , and SPPB scores from baseline to 6‐month follow‐up with a trend for improvement in self‐efficacy . Results suggest that the intervention was feasible , acceptable , and improved physical activity and function ",
"OBJECTIVE To assess the effect of a program of supervised fitness walking and patient education on functional status , pain , and use of medication in patients with osteoarthritis of the knee . DESIGN An 8-week r and omized , controlled trial . SETTING Inpatient and outpatient services of an orthopedic hospital in an academic medical center . PATIENTS A total of 102 patients with a documented diagnosis of primary osteoarthritis of one or both knees participated in the study . Data were obtained on 47 of 51 intervention patients and 45 of 51 control patients . INTERVENTIONS An 8-week program of supervised fitness walking and patient education or st and ard routine medical care . MEASUREMENTS Patients were evaluated and outcomes assessed before and after the intervention using a 6-minute test of walking distance and scores on the physical activity , arthritis impact , pain , and medication subscales of the Arthritis Impact Measurement Scale ( AIMS ) . RESULTS Patients r and omly assigned to the walking program had a 70-meter increase in walking distance relative to their baseline assessment , which represents an improvement of 18.4 % ( 95 % Cl , 9.8 % to 27.0 % ) . In contrast , controls showed a 17-meter decrease in walking distance relative to their baseline assessment ( P less than 0.001 ) . Improvements in functional status as measured by the AIMS physical activity subscale were also observed in the walking group but not in the control group ( P less than 0.001 ) ; patients assigned to the walking program improved 39 % ( Cl , 15.6 % to 60.4 % ) . Although changes in scores on the arthritis impact subscale were similar in the two groups ( P = 0.093 ) , the walking group experienced a decrease in arthritis pain of 27 % ( Cl , 9.6 % to 41.4 % ) ( P = 0.003 ) . Medication use was less frequent in the walking group than in the control group at the post-test ( P = 0.08 ) . CONCLUSIONS A program of supervised fitness walking and patient education can improve functional status without worsening pain or exacerbating arthritis-related symptoms in patients with osteoarthritis of the knee",
"Objectives : To determine , using unsupervised walking programmes , the effects of exercise at a level lower than currently recommended to improve cardiovascular risk factors and functional capacity . Design : 12 week r and omised controlled trial . Setting : Northern Irel and Civil Service ; home-based walking . Participants : 106 healthy , sedentary 40 to 61 year old adults of both sexes . Interventions : Participants were r and omly allocated to a walking programme ( 30 minutes brisk walking three days a week ( n = 44 ) or five days a week ( n = 42 ) ) or a control group ( n = 20 ) . Participants could choose to walk in bouts of at least 10 minutes . They used pedometers to record numbers of steps taken . Intention to treat analysis of changes within groups was done using paired t tests ; extent of change ( baseline to 12 week measurements ) was compared between groups using analysis of variance and Gabriel ’s post hoc test . Main outcome measures : Blood pressure , serum lipids , body mass index , waist : hip ratio , and functional capacity ( using a 10 m shuttle walk test ) . Main results : 89 % ( 93/106 ) completed the study . Systolic blood pressure and waist and hip circumferences fell significantly both in the three day group ( 5 mm Hg , 2.6 cm , and 2.4 cm , respectively ) and in the five day group ( 6 mm Hg , 2.5 cm , and 2.2 cm ) ( p Functional capacity increased in both groups ( 15 % ; 11 % ) . Diastolic blood pressure fell in the five day group ( 3.4 mm Hg , p<0.05 ) . No changes occurred in the control group . Conclusions : This study provides evidence of benefit from exercising at a level below that currently recommended in healthy sedentary adults . Further studies are needed of potential longer term health benefits for a wider community from low levels of exercise",
"Objective : To assess the effect of aerobic walking training as compared to active training , which includes muscle strengthening , on functional abilities among patients with chronic low back pain . Design : R and omized controlled clinical trial with blind assessors . Setting : Outpatient clinic . Subjects : Fifty-two sedentary patients , aged 18–65 years with chronic low back pain . Patients who were post surgery , post trauma , with cardiovascular problems , and with oncological disease were excluded . Intervention : Experimental ‘ walking ’ group : moderate intense treadmill walking ; control ‘ exercise ’ group : specific low back exercise ; both , twice a week for six weeks . Main measures : Six-minute walking test , Fear-Avoidance Belief Question naire , back and abdomen muscle endurance tests , Oswestry Disability Question naire , Low Back Pain Functional Scale ( LBPFS ) . Results : Significant improvements were noted in all outcome measures in both groups with non-significant difference between groups . The mean distance in metres covered during 6 minutes increased by 70.7 ( 95 % confidence interval ( CI ) 12.3–127.7 ) in the ‘ walking ’ group and by 43.8 ( 95 % CI 19.6–68.0 ) in the ‘ exercise ’ group . The trunk flexor endurance test showed significant improvement in both groups , increasing by 0.6 ( 95 % CI 0.0–1.1 ) in the ‘ walking ’ group and by 1.1 ( 95 % CI 0.3–1.8 ) in the ‘ exercise ’ group . Conclusions : A six-week walk training programme was as effective as six weeks of specific strengthening exercises programme for the low back",
"STUDY DESIGN Single-subject , multiple-baseline design across 3 subjects . OBJECTIVE To investigate the use of a quota-based approach to prescribing a walking program for individuals with fibromyalgia ( FM ) . BACKGROUND Exercise has been found to be beneficial for individuals with FM . What has not been determined is the best way to implement an exercise program that does not increase FM symptoms . METHODS AND MEASURES Three women with FM were r and omly assigned a baseline period of 5 , 6 , or 7 weeks , which served as the control phase , followed by an intervention period consisting of an 8-week walking program . The walking program progression was prescribed using a quota-based approach . Weekly outcome measures were the Fibromyalgia Impact Question naire ( FIQ ) , Arthritis Self-Efficacy Scale ( ASES ) , and SF-36v2 ( acute ) . A 6-minute walk test was recorded twice : at the start of the baseline phase ( after a trial phase ) and at the end of the intervention phase . RESULTS Subjects 1 and 3 had a significant decrease in the symptoms associated with FM during the intervention phase ( FIQ , P self-efficacy ( ASES ) . They increased their walking distances used for exercise by 640 and 480 m , respectively . Subject 2 had no significant improvements in her symptoms of FM . Despite a significant decrease in ASES ( P walking distance used for exercise by subject 2 increased by 2080 m. Six-minute walk test distances increased 76 , 32 , and 106 m for subjects 1 , 2 , and 3 , respectively . CONCLUSIONS Prescribing a walking program using a quota-based exercise prescription result ed in increasing the distance walked for 3 subjects . It also decreased symptoms associated with FM in 2 of the 3 subjects , but did not increase self-efficacy"
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BACKGROUND Cardiovascular disorders remain the leading cause of death in type 2 diabetic patients . In the present study , a systematic review and a meta- analysis of r and omised controlled trials ( RCTs ) were conducted aim ing to evaluate the effect of magnesium supplementation on type 2 diabetes ( T2D ) associated cardiovascular risk factors in both diabetic and nondiabetic individuals . METHODS PubMed , Scopus , Cochrane , Web of Science and Google Scholar data bases were search ed from inception to 30 June 2016 aim ing to identify RCTs evaluating the effect of magnesium supplementation on T2D associated cardiovascular risk factors . The data were analysed using a r and om effect model with inverse variance methodology . Sensitivity analysis , risk of bias analysis , subgroup analysis , meta-regression and publication bias analysis were also conducted for the included studies using st and ard methods . RESULTS Following magnesium supplementation , a significant improvement was observed in fasting plasma glucose ( FPG ) [ weighted mean difference ( WMD ) = -4.641 mg dL-1 , 95 % confidence interval ( CI ) = -7.602 , -1.680 , P = 0.002 ] , high-density lipoprotein ( HDL ) ( WMD = 3.197 mg dL-1 , 95 % CI = 1.455 , 4.938 , P low-density lipoprotein ( LDL ) ( WMD = -10.668 mg dL-1 , 95 % CI = -19.108 , -2.228 , P = 0.013 ) , plasma triglycerides ( TG ) ( WMD = -15.323 mg dL-1 , 95 % CI = -28.821 , -1.826 , P = 0.026 ) and systolic blood pressure ( SBP ) ( WMD = -3.056 mmHg , 95 % CI = -5.509 , -0.603 , P = 0.015 ) . During subgroup analysis , a more beneficial effect of magnesium supplementation was observed in diabetic subjects with hypomagnesaemia . CONCLUSIONS Magnesium supplementation can produce a favourable effect on FPG , HDL , LDL , TG and SBP . Therefore , magnesium supplementation may decrease the risk T2D associated cardiovascular diseases , although future large RCTs are needed for making robust guidelines for clinical practice
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"OBJECTIVE The objective of this study was to determine potential added value of novel risk factors in predicting the development of type 2 diabetes beyond that provided by st and ard clinical risk factors . RESEARCH DESIGN AND METHODS The Atherosclerosis Risk in Communities ( ARIC ) Study is a population -based prospect i ve cohort study in four U.S. communities . Novel risk factors were either measured in the full cohort or in a case-control sample nested within the cohort . We started with a basic prediction model , previously vali date d in ARIC , and evaluated 35 novel risk factors by adding them independently to the basic model . The area under the curve ( AUC ) , net reclassification index ( NRI ) , and integrated discrimination index ( IDI ) were calculated to determine if each of the novel risk factors improved risk prediction . RESULTS There were 1,457 incident cases of diabetes with a mean of > 7.6 years of follow-up among 12,277 participants at risk . None of the novel risk factors significantly improved the AUC . Forced expiratory volume in 1 s was the only novel risk factor that result ed in a significant NRI ( 0.54 % ; 95 % CI : 0.33–0.86 % ) . Adiponectin , leptin , γ-glutamyl transferase , ferritin , intercellular adhesion molecule 1 , complement C3 , white blood cell count , albumin , activated partial thromboplastin time , factor VIII , magnesium , hip circumference , heart rate , and a genetic risk score each significantly improved the IDI , but net changes were small . CONCLUSIONS Evaluation of a large panel of novel risk factors for type 2 diabetes indicated only small improvements in risk prediction , which are unlikely to meaningfully alter clinical risk reclassification or discrimination strategies",
"OBJECTIVE Hypomagnesemia occurs in 25–38 % of patients with type 2 diabetes . Several studies have suggested an association between magnesium ( Mg ) depletion and insulin resistance and /or reduction of insulin secretion in these cases . Our purpose was to evaluate if Mg supplementation ( as magnesium oxide [ MgO ] ) would improve metabolic control in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS We studied 128 patients with type 2 diabetes ( 32 men , 96 women , aged 30–69 years ) , treated by diet or diet plus oral antidiabetic drugs , in the Bahia Federal University Hospital , Brazil . Patients at risk for hypomagnesemia or with reduced renal function were excluded . This study was a clinical r and omized double-blind placebo-controlled trial . Patients received either placebo , 20.7 mmol MgO , or 41.4 mmol MgO daily(elementary Mg ) for 30 days . Mg concentrations were measured in plasma , in mononuclear cells , and in 24-h urine sample s. Fasting blood glucose , HbA1 , and fructosamine were used as parameters of metabolic control . RESULTS Of the patients , 47.7 % had low plasma Mg , and 31.1 % had low intramononuclear Mg levels . Intracellular Mg in patients with diabetes was significantly lower than in the normal population ( 62 blood donors ; 1.4 ± 0.6 vs. 1.7 ± 0.6 μg/mg of total proteins ) . No correlation was found between plasma and intracellular Mg concentrations ( r = −0.179 ; P = 0.15 ) or between Mg concentrations and glycemic control ( r = −0.165 ; P = 0.12 ) . Intracellular Mg levels were lower in patients with peripheral neuropathy than in those without ( 1.2 ± 0.5 vs. 1.5 ± 0.6 μg/mg ) . Similar findings were observed in patients with coronary disease ( 1.0 ± 0.5 vs. 1.5 ± 0.6 μg/mg ) . In the placebo and in the 20.7 mmol Mg groups , neither a change in plasma and intracellular levels nor an improvement in glycemic control were observed . Replacement with 41.4 mmol Mg tended to increase plasma , cellular , and urine Mg and caused a significant fall ( 4.1 ± 0.8 to 3.8 ± 0.7 mmol/1 ) in fructosamine ( normal , 1.87–2.87 mmol/1 ) . CONCLUSIONS Mg depletion is common in poorly controlled patients with type 2 diabetes , especially in those with neuropathy or coronary disease . More prolonged use of Mg in doses that are higher than usual is needed toestablish its routine or selective administration in patients with type 2 diabetes to improve control or prevent chronic complications",
"Literature data on the bioavailability of various Mg forms provide scarce information on the best Mg salt to be used in animal and human supplementation . This study aim ed to investigate the bioavailability of different forms of Mg in rats using Mg stable isotopes . Eighty male Wistar rats aged 6 weeks were fed a semi-purified Mg-depleted diet for three weeks . The rats were then r and omised into ten groups and received , for two more weeks , the same diet repleted with Mg ( 550 mg Mg/kg ) as : oxide , chloride , sulphate , carbonate , acetate , pidolate , citrate , gluconate , lactate or aspartate . After 10 days of Mg-repleted diet , the rats received orally 1.8 mg of an enriched 26Mg . Faeces and urine were then collected for 4 consecutive days . Isotope ratios in faeces and urine were determined . The Mg absorption values obtained varied from 50 % to 67 % . Organic Mg salts were slightly more available than inorganic Mg salts . Mg gluconate exhibited the highest Mg bioavailability of the ten Mg salts studied . Urinary 26Mg excretion varied from 0.20 mg to 0.33 mg , and feeding with the organic pidolate , citrate , gluconate and aspartate salts result ed in higher urinary 26Mg excretion than with inorganic salts . Ultimately , 26Mg retention was higher in the rats receiving the organic salts such as gluconate , lactate and aspartate than in those receiving the inorganic salts . Taken together , these results indicate that 26Mg is sufficiently bioavailable from the ten different Mg salts studied in the present experiment , although Mg gluconate exhibited the highest bioavailability under these experimental conditions",
"Oral magnesium ( Mg ) supplementation can improve insulin sensitivity and secretion in patients with Type 2 diabetes mellitus ( DM ) . We studied the effect of Mg supplementation on glycaemic control , blood pressure , and plasma lipids in insulin-requiring patients with Type 2 DM . Fifty moderately controlled patients were r and omized to 15 mmol Mg or placebo daily for 3 months . Plasma Mg , glucose , HbA1c , lipids , erythrocyte Mg , Mg and glucose concentrations in 24-h urine , and systolic and diastolic pressure were measured before and after 3 months treatment . Plasma Mg concentration was higher after supplementation than after placebo ( 0.82 + /- 0.07 vs 0.78 + /- 0.08 mmol l(-1 ) , p Mg excretion ( 5.5 + /- 1.9 vs 3.7 + /- 1.4 mmol 24 h(-1 ) , p = 0.004 ) but erythrocyte Mg concentrations were similar . No significant differences were found in glycaemic control ( glucose : 10.7 + /- 3.8 vs 11.6 + /- 6.2 mmol l(-1 ) , p = 0.8 ; HbA1c : 8.9 + /- 1.6 vs 9.1 + /- 1.2 % , p = 0.8 ) , lipids or blood pressure . On-treatment analysis ( 34 patients : 18 on Mg , 16 on placebo ) yielded similar results . An increase in plasma Mg concentration irrespective of medication was associated with a tendency to a decrease in diastolic pressure ( increased plasma Mg vs no increase : -4.0 + /- 10.1 vs + 2.5 + /- 12.0 mmHg , p = 0.059 ) . Three months ' oral Mg supplementation of insulin-requiring patients with Type 2 DM increased plasma Mg concentration and urinary Mg excretion but had no effect on glycaemic control or plasma lipid concentrations",
"To evaluate the efficacy and safety of oral magnesium supplementation , with magnesium chloride ( MgCl2 ) , in the treatment of newly diagnosed depression in the elderly with type 2 diabetes and hypomagnesemia . Twenty-three elderly patients with type 2 diabetes and hypomagnesemia were enrolled and r and omly allocated to receive either 50 mL of MgCl2 5 % solution equivalent to 450 mg of elemental magnesium or Imipramine 50 mg daily during 12 weeks . Widowhood or divorce in the last six months , alcoholism , degenerative illnesses of the nervous central system , recent diagnosis of diabetes , previous or current treatment with antidepressants , chronic diarrhea , use of diuretics , and reduced renal function were exclusion criteria . Hypomagnesemia was defined by serum magnesium levels or = 11 points . The primary trial end point was the improvement of depression symptoms . At baseline , there were no differences by age ( 69 + /- 5.9 and 66.4 + /- 6.1 years , p = 0.39 ) , duration of diabetes ( 11.8 + /- 7.9 and 8.6 + /- 5.7 years , p = 0.33 ) , serum magnesium levels ( 1.3 + /- 0.04 and 1.4 + /- 0.04 mg/dL , p = 0.09 ) , and Yasavage and Brink Score ( 17.9 + /- 3.9 and 16.1 + /- 4.5 point , p = 0.34 ) in the groups with MgCl2 and imipramine , respectively . At end of follow-up , there were no significant differences in the Yasavage and Brink score ( 11.4 + /- 3.8 and 10.9 + /- 4.3 , p = 0.27 ) between the groups in study ; whereas serum magnesium levels were significantly higher in the group with MgCl2 ( 2.1 + /- 0.08 mg/dL ) than in the subjects with imipramine ( 1.5 + /- 0.07 mg/dL ) , p imipramine 50 mg daily",
"We demonstrated similar plasma concentrations and urinary losses but lower erythrocyte magnesium concentrations ( 2.18 + /- 0.04 vs 1.86 + /- 0.03 mmol/L , P less than 0.01 ) in twelve aged ( 77.8 + /- 2.1 y ) vs 25 young ( 36.1 + /- 0.4 y ) , nonobese subjects . Subsequently , aged subjects were enrolled in a double-blind , r and omized , crossover study in which placebo ( for 4 wk ) and chronic magnesium administration ( CMA ) ( 4.5 g/d for 4 wk ) were provided . At the end of each treatment period an intravenous glucose tolerance test ( 0.33 g/kg body wt ) and a euglycemic glucose clamp with simultaneous [D-3H]glucose infusion and indirect calorimetry were performed . CMA vs placebo significantly increased erythrocyte magnesium concentration and improved insulin response and action . Net increase in erythrocyte magnesium significantly and positively correlated with the decrease in erythrocyte membrane microviscosity and with the net increase in both insulin secretion and action . In aged patients , correction of a low erythrocyte magnesium concentration may allow an improvement of glucose h and ling",
"BACKGROUND AND AIMS It has been suggested that magnesium deficiency is associated with the triggering of acute phase response , which may contribute to type 2 diabetes and cardiovascular disease risk . We undertook this study to determine whether oral magnesium supplementation modifies serum levels of high-sensitivity C-reactive protein ( hsCRP ) in apparently healthy subjects with prediabetes and hypomagnesemia . METHODS A total of 62 men and non-pregnant women aged 18 - 65 year , with new diagnosis of prediabetes ( glucose 5.6 were enrolled in a clinical double-blind placebo-controlled trial and r and omly allocated to receive either magnesium chloride ( 30 mL of MgCl2 5 % solution ) or NaHCO3 0.1 % solution , once daily for 3 months . RESULTS At basal conditions , anthropometric and biochemical variables were similarly distributed in both groups . At the end of follow-up , participants who received magnesium chloride showed higher serum magnesium levels ( 0.86 ± 0.08 vs. 0.69 ± 0.16 mmol/L , p = 0.002 ) and lower hsCRP levels ( 4.8 ± 15.2 vs. 17.1 ± 21.0 nmol/L , p = 0.01 ) compared with participants in the control group . CONCLUSIONS Oral magnesium supplementation decreases hsCRP levels in apparently healthy subjects with prediabetes and hypomagnesemia",
"AIM This study evaluated the efficacy of oral magnesium supplementation in the reduction of plasma glucose levels in adults with prediabetes and hypomagnesaemia . METHODS A total of 116 men and non-pregnant women , aged 30 to 65 years with hypomagnesaemia and newly diagnosed with prediabetes , were enrolled into a r and omized double-blind placebo-controlled trial to receive either 30 mL of MgCl2 5 % solution ( equivalent to 382 mg of magnesium ) or an inert placebo solution once daily for four months . The primary trial endpoint was the efficacy of magnesium supplementation in reducing plasma glucose levels . RESULTS At baseline , there were no significant statistical differences in terms of anthropometric and biochemical variables between individuals in the supplement and placebo groups . At the end of follow-up , fasting ( 86.9 ± 7.9 and 98.3 ± 4.6 mg/dL , respectively ; P = 0.004 ) and post-load glucose ( 124.7 ± 33.4 and 136.7 ± 23.9 mg/dL , respectively ; P = 0.03 ) levels , HOMA-IR indices ( 2.85 ± 1.0 and 4.1 ± 2.7 , respectively ; P = 0.04 ) and triglycerides ( 166.4 ± 90.6 and 227.0 ± 89.7 , respectively ; P = 0.009 ) were significantly decreased , whereas HDL cholesterol ( 45.6 ± 10.9 and 46.8 ± 9.2 mg/dL , respectively ; P = 0.04 ) and serum magnesium ( 1.96 ± 0.27 and 1.60 ± 0.26 mg/dL , respectively ; P = 0.005 ) levels were significantly increased in those taking MgCl2 compared with the controls . A total of 34 ( 29.4 % ) people improved their glucose status ( 50.8 % and 7.0 % in the magnesium and placebo groups , respectively ; P that magnesium supplementation reduces plasma glucose levels , and improves the glycaemic status of adults with prediabetes and hypomagnesaemia",
"OBJECTIVE To evaluate the impact of oral magnesium supplementation on risk factors for end-organ disease in patients with non-insulin-dependent diabetes mellitus ( NIDDM ) . DESIGN A 16-week r and omized , double-blind , placebo-controlled crossover trial . SETTING Outpatient center of an academic family medicine residency program . PATIENTS Twenty-eight patients ( age range , 28 to 84 years ; 57.1 % black ; 85.7 % women ) with NIDDM controlled by diet and /or an oral hypoglycemic , with a serum cholesterol levels over 5.20 mmol/L ( 200 mg/dL ) . INTERVENTION Following a 2-week placebo run-in period , each patient was r and omized to receive either sustained-release magnesium chloride ( Slo-Mag ) , 384 mg/d , or an identical-appearing placebo for 6 weeks . After a 2-week interim washout period , each patient was then treated with the alternative regimen for an additional 6-week period . MAIN OUTCOME MEASURES The systolic and diastolic blood pressure and levels of serum glucose , low-density and high-density lipoprotein and total cholesterol , triglycerides , and serum and total erythrocyte magnesium were measured at the beginning , midpoint , and end of each 6-week treatment phase . RESULTS Systolic blood pressure fell an average of 7.4 mm Hg ( P diastolic blood pressure or levels of serum glucose , low-density and high-density lipoprotein and total cholesterol , triglycerides , or serum and erythrocyte magnesium . CONCLUSIONS Oral magnesium supplementation in the doses and duration studied is modestly effective in reducing systolic blood pressure in patients with NIDDM but has little impact on other important biochemical parameters related to diabetes-associated end-organ disease",
"BACKGROUND Given that role of magnesium in insulin secretion is uncertain , our objective was to determine whether oral supplementation with magnesium chloride ( MgCl(2 ) ) improves the ability of beta-cells to compensate for variations in insulin sensitivity in non-diabetic individuals with significant hypomagnesaemia . MATERIAL S AND METHODS Eligible individuals were non-diabetic , normo-tensive men and non-diabetic , normo-tensive , non-pregnant women with serum magnesium levels ≤0·70 mM/L ; they were enrolled in a r and omized double-blind clinical trial to receive either 50 mL of 5 % MgCl(2 ) solution or 50 mL of inactive solution daily for 3 months . The primary trial end point was a change in the AUC of the hyperbolic model of beta-cell function ( HMbCF ) derived from the fasting state . Individuals , caregivers and personnel who assessed the outcomes were all blinded to the group assignments . RESULTS A total of 54 and 52 individuals were assigned to the MgCl(2 ) and placebo groups , respectively ; five individuals in the MgCl(2 ) group and four in the placebo group dropped out . There were no serious adverse events or side effects because of MgCl(2 ) or placebo . At the beginning of the study , the AUC of the HMbCF was similar in both groups ( AUC = 7·591 and 7·895 cm(2 ) ) ; at the end of follow-up , the curve of the MgCl(2 ) group showed a hyperbolic distribution ( AUC = 18·855 cm(2 ) ) , whereas in the placebo group , there were no changes ( AUC = 7·631 cm(2 ) ) . CONCLUSIONS MgCl(2 ) 2·5 g daily improves the ability of beta-cells to compensate for variations in insulin sensitivity in non-diabetic individuals with significant hypomagnesaemia",
"BACKGROUND In patients with established cardiovascular disease , residual cardiovascular risk persists despite the achievement of target low-density lipoprotein ( LDL ) cholesterol levels with statin therapy . It is unclear whether extended-release niacin added to simvastatin to raise low levels of high-density lipoprotein ( HDL ) cholesterol is superior to simvastatin alone in reducing such residual risk . METHODS We r and omly assigned eligible patients to receive extended-release niacin , 1500 to 2000 mg per day , or matching placebo . All patients received simvastatin , 40 to 80 mg per day , plus ezetimibe , 10 mg per day , if needed , to maintain an LDL cholesterol level of 40 to 80 mg per deciliter ( 1.03 to 2.07 mmol per liter ) . The primary end point was the first event of the composite of death from coronary heart disease , nonfatal myocardial infa rct ion , ischemic stroke , hospitalization for an acute coronary syndrome , or symptom-driven coronary or cerebral revascularization . RESULTS A total of 3414 patients were r and omly assigned to receive niacin ( 1718 ) or placebo ( 1696 ) . The trial was stopped after a mean follow-up period of 3 years owing to a lack of efficacy . At 2 years , niacin therapy had significantly increased the median HDL cholesterol level from 35 mg per deciliter ( 0.91 mmol per liter ) to 42 mg per deciliter ( 1.08 mmol per liter ) , lowered the triglyceride level from 164 mg per deciliter ( 1.85 mmol per liter ) to 122 mg per deciliter ( 1.38 mmol per liter ) , and lowered the LDL cholesterol level from 74 mg per deciliter ( 1.91 mmol per liter ) to 62 mg per deciliter ( 1.60 mmol per liter ) . The primary end point occurred in 282 patients in the niacin group ( 16.4 % ) and in 274 patients in the placebo group ( 16.2 % ) ( hazard ratio , 1.02 ; 95 % confidence interval , 0.87 to 1.21 ; P=0.79 by the log-rank test ) . CONCLUSIONS Among patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of less than 70 mg per deciliter ( 1.81 mmol per liter ) , there was no incremental clinical benefit from the addition of niacin to statin therapy during a 36-month follow-up period , despite significant improvements in HDL cholesterol and triglyceride levels . ( Funded by the National Heart , Lung , and Blood Institute and Abbott Laboratories ; AIM -HIGH Clinical Trials.gov number , NCT00120289 . )",
"We evaluated the effects of oral magnesium supplementation on plasma lipid concentrations in patients with non-insulin-dependent diabetes mellitus . Twenty-six persons with non-insulin-dependent diabetes mellitus received 4.5 g magnesium pidolate/d for one month , and 17 persons received placebo . Before and at the end of the treatment period cholesterol concentration , triglycerides , LDL cholesterol , HDL cholesterol , and plasma and erythrocyte magnesium were evaluated . Chronic magnesium supplementation produced a significant reduction of plasma cholesterol and LDL cholesterol , and an increase of HDL cholesterol . These results suggest that oral supplementation of magnesium may be useful in the treatment of hyperlipidaemia in patients with non-insulin-dependent diabetes mellitus",
"In eight aged non-insulin-dependent diabetes mellitus ( NIDDM ) subjects , insulin response and action were studied before and after chronic magnesium supplementation ( 2 g/day ) to diet . Chronic magnesium supplementation to diet versus placebo produced 7 ) a significant increase in plasma ( 0.83 ± 0.05 vs. 0.78 ± 0.06 mM , P erythrocyte ( 2.03 ± 0.06 vs. 1.88 ± 0.09 mM , P levels , 2 ) an increase in acute insulin response ( AIR ) ( 4.0 ± 0.6 vs. - 1 .6 ± 0.6 mU/L , P .05 ) to glucose pulse , and 3 ) an increase in glucose infusion rate ( GIR ) ( 3.6 ± 0.6 vs. 2.9 ± 0.5 mg kg∼1 min−1 P min ) glucose clamp . Net increase in AIR , glucose disappearance rate after glucose pulse , and GIR were significantly and positively correlated to the net increase in erythrocyte magnesium content calculated after chronic magnesium supplementation to diet . In conclusion , our data suggest that NIDDM subjects may benefit from therapeutic chronic administration of magnesium salts",
"The aim of the present study was to investigate the effects of magnesium supplementation on glucose uptake and substrate oxidation in noninsulin-dependent ( type II ) diabetic patients . Nine elderly non-obese noninsulin-dependent ( type II ) diabetic patients , treated by diet only , participated in the study , which was design ed as r and omized , double blind , and cross-over . Each patient was followed up for a pre study period of 3 weeks before inviting him/her to receive placebo or magnesium supplementation ( 15.8 mmol/day ) for 4 weeks . At the end of each treatment period , a euglycemic hyperinsulinemic glucose clamp with simultaneous D-[3 - 3H]glucose infusion and indirect calorimetry was performed . Magnesium supplementation result ed in significantly increased plasma and erythrocyte magnesium levels , whereas body weight and fasting plasma glucose did not change . In the last 60 min of the glucose clamp , insulin-mediated glucose disappearance , total body glucose disposal ( 24.5 + /- 0.4 vs. 28.2 + /- 0.7 mumol/kg.min ; P glucose oxidation ( 13.0 + /- 0.4 vs. 16.3 + /- 0.8 mumol/kg.min ; P Endogenous glucose production , nonoxidative glucose disposal , lipid and protein oxidation , and insulin MCR were not affected . In conclusion , a 4-week magnesium supplementation improves insulin sensitivity and glucose oxidation in the course of a euglycemic-hyperinsulinemic glucose clamp in noninsulin-dependent diabetic patients . Long term studies are needed to determine whether magnesium supplementation is useful in the management of type II diabetes",
"BACKGROUND Patients with evidence of vascular disease are at increased risk for subsequent vascular events despite effective use of statins to lower the low-density lipoprotein ( LDL ) cholesterol level . Niacin lowers the LDL cholesterol level and raises the high-density lipoprotein ( HDL ) cholesterol level , but its clinical efficacy and safety are uncertain . METHODS After a prer and omization run-in phase to st and ardize the background statin-based LDL cholesterol-lowering therapy and to establish participants ' ability to take extended-release niacin without clinical ly significant adverse effects , we r and omly assigned 25,673 adults with vascular disease to receive 2 g of extended-release niacin and 40 mg of laropiprant or a matching placebo daily . The primary outcome was the first major vascular event ( nonfatal myocardial infa rct ion , death from coronary causes , stroke , or arterial revascularization ) . RESULTS During a median follow-up period of 3.9 years , participants who were assigned to extended-release niacin-laropiprant had an LDL cholesterol level that was an average of 10 mg per deciliter ( 0.25 mmol per liter as measured in the central laboratory ) lower and an HDL cholesterol level that was an average of 6 mg per deciliter ( 0.16 mmol per liter ) higher than the levels in those assigned to placebo . Assignment to niacin-laropiprant , as compared with assignment to placebo , had no significant effect on the incidence of major vascular events ( 13.2 % and 13.7 % of participants with an event , respectively ; rate ratio , 0.96 ; 95 % confidence interval [ CI ] , 0.90 to 1.03 ; P=0.29 ) . Niacin-laropiprant was associated with an increased incidence of disturbances in diabetes control that were considered to be serious ( absolute excess as compared with placebo , 3.7 percentage points ; P incidence of diabetes diagnoses ( absolute excess , 1.3 percentage points ; P serious adverse events associated with the gastrointestinal system ( absolute excess , 1.0 percentage point ; P musculoskeletal system ( absolute excess , 0.7 percentage points ; P skin ( absolute excess , 0.3 percentage points ; P=0.003 ) , and unexpectedly , infection ( absolute excess , 1.4 percentage points ; P and bleeding ( absolute excess , 0.7 percentage points ; P Among participants with atherosclerotic vascular disease , the addition of extended-release niacin-laropiprant to statin-based LDL cholesterol-lowering therapy did not significantly reduce the risk of major vascular events but did increase the risk of serious adverse events . ( Funded by Merck and others ; HPS2-THRIVE Clinical Trials.gov number , NCT00461630 . )",
"To test the blood pressure (BP)-lowering effect of oral magnesium supplementation ( that is , magnesium chloride ( MgCl2 ) solution ) in diabetic hypertensive adults with hypomagnesaemia not on diuretic treatment but receiving concurrent captopril , we conducted a double-blind , placebo-controlled trial . Eighty-two subjects between 40 and 75 years of age were r and omly enrolled . Over 4 months , subjects in the intervention group received 2.5 g of MgCl2 ( 50 ml of a solution containing 50 g of MgCl2 per 1000 ml of solution ) equivalent to 450 mg of elemental magnesium , and control subjects inert placebo . The primary trial end point was a reduction in systolic ( SBP ) and diastolic ( DBP ) blood pressure . Complete follow-up was achieved for 79 of the 82 r and omized subjects . SBP ( −20.4±15.9 versus −4.7 ± 12.7 mm Hg , P=0.03 ) and DBP ( −8.7±16.3 versus −1.2±12.6 mm Hg , P=0.02 ) showed significant decreases , and high-density lipoprotein-cholesterol ( 0.1±0.6 versus −0.1±0.7 mmol l−1 , P=0.04 ) a significant increase in the magnesium group compared to the placebo group . The adjusted odds ratio between serum magnesium and BP was 2.8 ( 95%CI : 1.4–6.9 ) . Oral magnesium supplementation with MgCl2 significantly reduces SBP and DBP in diabetic hypertensive adults with hypomagnesaemia",
"Background : Magnesium is the second most abundant intracellular cation . It plays an important role in insulin homeostasis and glucose metabolism through multiple enzymatic reactions . With increasing data on magnesium deficiency in diabetic patients and epidemiological studies demonstrating magnesium deficiency as a risk factor for diabetes , it is logical to search for its possible beneficial effects on diabetes control and prevention . We aim ed to determine whether oral magnesium supplementation improves metabolic control , lipid profile and blood pressure in patients with type II diabetes . Methods : Fifty four patients with type II diabetes were included in a r and omized double blind placebocontrolled clinical trial . Patients received either placebo or 300 mg elemental magnesium ( as magnesium sulfate -MgSo4- ) daily , for 3 months . Metabolic control , lipid profile , blood pressure , magnesium status , hepatic enzymes , hemoglobin concentration , and anthropometric indices were determined in the beginning and at the end of the study . Results : Daily administration of 300 mg elemental magnesium for 3 months , significantly improved fasting blood glucose ( 183.9±15.43 to 125.8±6.52 vs. 196.5±28.12 to 136.5±7.94 , p ( 239.1±74.75 to 189.1±60mg/dl vs. 246.4±97.37 to 247.8±86.74mg/dl , p . Conclusion : Oral magnesium supplementation with proper dosage has beneficial effects on blood glucose , lipid profile , and blood pressure in patients with type II diabetes",
"BACKGROUND AND AIM Little is known about the effect of magnesium on insulin sensitivity and BP in healthy individuals . Therefore , we investigated whether magnesium could improve insulin sensitivity and blood pressure ( BP ) in normo-magnesemic nondiabetic overweight adults . METHODS AND RESULTS In a double-blinded , placebo-controlled , r and omized trial , a total of 155 participants ( BMI > or = 23 kg/m(2 ) ) received either 12.3 mmol ( 300 mg ) of elemental magnesium in the form of magnesium oxide ( n=75 ) or placebo ( n=80 ) each day for 12 weeks , constituting the intent-to-treat population . A repeated- measures ANOVA was used to evaluate the between-group changes in variables during the study . The baseline characteristics between the intervention and control groups were similar . There were no significant differences between the groups in the pattern of change of the homeostasis model assessment insulin resistance index , BP over time during the 12-week study . In subgroup analysis , magnesium supplementation ( n=8 , 27 , and 24 , respectively ) lowered BP much more than placebo ( n=16 , 29 , and 25 , respectively ) in those subjects whose systolic BP > or = 140 mmHg , diastolic BP 80 - 90 mmHg , and diastolic BP > or = 90 mmHg at the start of the study ( P=0.016 , 0.043 , and 0.023 , respectively ) ; in comparison , those subjects whose initial BP reading was low at baseline did not show a change in BP . No significant adverse events related to magnesium supplementation were recorded . CONCLUSIONS These results suggested that magnesium supplementation does not reduce BP and enhance insulin sensitivity in normo-magnesemic nondiabetic overweight people . However , it appears that magnesium supplementation may lower BP in healthy adults with higher BP",
"OBJECTIVE Although hypomagnesemia reduces insulin sensitivity , benefits of magnesium supplementation to non-diabetic insulin resistant subjects has not been established . Our purpose was to determine whether oral magnesium supplementation with magnesium chloride ( MgCl2 ) 2.5 g daily modify insulin sensitivity in non-diabetic subjects . MATERIAL AND METHODS This study was a 3 months r and omized double-blind placebo-controlled trial . Apparently healthy subjects were eligible to participate if they had insulin resistance ( HOMA-IR index equal or greater than 3.0 ) and hypomagnesemia ( Serum magnesium levels equal or lower than 0.74 mmol/l ) . Subjects were r and omized to receive either , MgCl2 2.5 g daily or placebo by 3-months . RESULTS At baseline there were not significant anthropometric or laboratory differences between both groups . At ending of the study , magnesium-supplemented subjects significantly increased their serum magnesium levels ( 0.61 + /- 0.08 to 0.81 + /- 0.08 mmol/l , p HOMA-IR index ( 4.6 + /- 2.8 to 2.6 + /- 1.1 , p magnesium supplementation improves insulin sensitivity in hypomagnesemic non-diabetic subjects . Clinical implication s of this finding have to be established",
"OBJECTIVE To investigate the effects of long-term high-dose oral magnesium ( Mg ) therapy ( 30 mmol/day ) in patients with type II diabetes . Low plasma magnesium levels have been reported in type II diabetes and are associated with insulin resistance and diabetic late complications . RESEARCH DESIGN AND METHODS Forty patients with type II diabetes and hypomagnesemia were observed in a r and omized double-blind placebo-controlled trial for 3 months ( body mass index : 28 ± 4 kg/m2 ; HbA1c : 7.4 ± 0.8 % ) . Plasma and urine magnesium and metabolic control parameters were determined , and side effects were considered , especially with regard to patients ' compliance . RESULTS A significant increase in plasma magnesium levels was observed after 3 months of treatment ( Mg : 0.73 ± 0.8 vs. 0.81 ±0.1 mmol/1 ) , reaching magnesium levels of the control group ( 0.88 ± 0.8 mmol/1 ; NS ) ; metabolic control , however , was not altered ( HbA1c : 7.2 ± 0.7 vs. 7.4 ± 0.9 % ) . Six months after the end of the trial , plasma magnesium declined to pretreatment levels ( Mg : 0.73 ± 0.07 mmol/1 ) . The prevalence of side effects was high at the beginning and was reduced significantly during treatment . CONCLUSIONS We conclude that oral magnesium replacement therapy corrects hypomagnesemia after a minimum treatment period of 3 months . These observations might be important for the prevention of diabetic late complications",
"The effect of magnesium ( Mg ) and ascorbic acid ( AA ) supplementation on metabolic control was assessed in 56 outpatient diabetics . A 90-day run-in period was followed by two 90-day treatment periods , during which Mg ( 600 mg/day ) and AA ( 2 g/day ) were administered in a r and omized double-blind cross-over fashion . A decrease in systolic and diastolic blood pressure ( 132 + /- 3 vs. 138 + /- 4 and 77 + /- 2 vs. 82 + /- 2 mm Hg ; p insulin-dependent diabetes mellitus subjects during Mg supplementation . No beneficial effect of Mg supplementation was observed on glycemic control , lipids or blood pressure in non-insulin-dependent diabetes mellitus ( NIDDM ) subjects . AA supplementation improved glycemic control among NIDDM subjects and both fasting blood glucose ( 9.1 + /- 0.5 vs. 10.1 + /- 0.6 mmol/l ; p HbA1c ( 8.5 + /- 0.3 vs. 9.3 + /- 0.3 % ; p AA supplementation on cholesterol ( 5.9 + /- 0.2 vs. 6.2 + /- 0.2 mmol/l ; p triglycerides ( 2.2 + /- 0.2 vs. 2.5 + /- 0.2 ; p AA supplementation may have a beneficial effect in NIDDM subjects on both glycemic control and blood lipids"
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41182b1a-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Surgical resection for early stage non-small cell lung cancer ( NSCLC ) offers the best chance of cure , but is associated with a risk of postoperative pulmonary complications ( i.e. pneumonia ( new infiltrate coupled with either fever ( > 38º C ) and purulent secretions , or fever and white cell count > 11,000 ) , bronchopleural fistula , severe atelectasis that requires chest physiotherapy or bronchoscopy , and prolonged mechanical ventilation ( > 48 hours ) ) . It is currently unclear if preoperative exercise training , and the potential result ant improvement in exercise capacity , may also improve postoperative outcomes , such as the risk of developing postoperative pulmonary complications , the length of postoperative intercostal drainage , or the length of hospital stay . OBJECTIVES The primary aims of this study were to determine the effect of preoperative exercise training on postoperative outcomes , such as risk of developing a postoperative pulmonary complication , and postoperative duration of intercostal catheter use in adults scheduled to undergo lung resection for NSCLC . The secondary aims of this study were to determine the effect of preoperative exercise training on length of hospital stay , fatigue , dyspnoea , exercise capacity , lung function , and postoperative mortality . SEARCH METHODS We search ed CENTRAL , MEDLINE ( PubMed ) , Embase Ovid , PEDro , and SciELO on the 28th of November 2016 . SELECTION CRITERIA We included r and omised controlled trials ( RCTs ) in which study participants who were scheduled to undergo lung resection for NSCLC were allocated to receive either preoperative exercise training or no exercise training . DATA COLLECTION AND ANALYSIS Two review authors independently screened the studies and selected those for inclusion . We performed meta-analyses for the outcomes : risk of developing a postoperative pulmonary complication ; postoperative duration of intercostal catheter ; length of hospital stay ; post-intervention exercise capacity ( 6-minute walk distance ) , and post-intervention forced vital capacity ( FVC ) . Although three studies reported post-intervention forced expiratory volume in 1 second ( FEV1 ) , we did not perform meta- analysis on this outcome due to significant statistical heterogeneity ( I² = 93 % ) across the studies . Data were not available for fatigue or dyspnoea . One study reported no in-hospital postoperative mortality in either the exercise or the non-exercise groups . MAIN RESULTS We identified five RCTs involving 167 participants ( mean age ranged from 54 to 72.5 years ; sample size ranged from 19 to 60 participants ) . Overall , we found that the risk of bias in the included studies was high , and the quality of evidence for all outcomes was low . Pooled data from four studies demonstrated that preoperative exercise training reduced the risk of developing a postoperative pulmonary complication by 67 % ( risk ratio ( RR ) 0.33 , 95 % CI 0.17 to 0.61 ) . The number of days patients in the exercise group needed an intercostal catheter was lower than in the non-exercise group ( mean difference ( MD ) -3.33 days , 95 % CI -5.35 to -1.30 days ; two studies ) ; postoperative length of hospital stay was also lower in the exercise group ( MD -4.24 days , 95 % CI -5.43 to -3.06 days ; four studies ) . Pooled data from two studies demonstrated that compared to the non-exercise group , post-intervention 6-minute walk distance ( MD 18.23 m , 95 % CI 8.50 to 27.96 m ) , and post-intervention FVC ( MD 2.97 % predicted , 95 % CI 1.78 to 4.16 % predicted ) were higher in the exercise group . AUTHORS ' CONCLUSIONS Preoperative exercise training may reduce the risk of developing a postoperative pulmonary complication , the duration of intercostal catheter use , postoperative length of hospital stay , and improve both exercise capacity and FVC in people undergoing lung resection for NSCLC . The findings of this review should be interpreted with caution due to disparities between the studies , risk of bias , and small sample sizes . This review emphasises the need for larger RCTs
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"OBJECTIVES Physical activity has been infrequently measured objective ly in non-small cell lung cancer ( NSCLC ) . We aim ed to investigate levels of physical activity , functional and patient reported outcomes at diagnosis and over six months in participants with recently diagnosed NSCLC and compare results with both physical activity guidelines and outcomes of similar-aged healthy individuals . METHODS This prospect i ve observational study assessed 50 individuals from three Australian tertiary hospitals with stage I-IIIB NSCLC at diagnosis , then 10 weeks and six months later . Thirty five healthy individuals without cancer were assessed once . Outcome measures included tri-axial accelerometery ( number of steps per day ) , six minute walk distance ( 6MWD ) , muscle strength and question naires including health-related quality of life ( HRQoL ) . RESULTS Individuals with NSCLC were engaged in significantly less physical activity than similar-aged healthy individuals , with 60 % not meeting physical activity guidelines . At diagnosis they had worse quadriceps strength , nutritional status and HRQoL. Over six months , participants with NSCLC experienced decline in self-reported physical activity , 6MWD and muscle strength , and worsening symptoms . CONCLUSION At diagnosis individuals with NSCLC engage in less physical activity , are weaker and more depressed than healthy individuals and their self-reported physical activity declines over six months . Future studies are required to investigate the efficacy of interventions to increase physical activity ",
"Background Postoperative pulmonary complications ( PPC ) are the most frequently observed complications following lung resection , of which pneumonia and atelectasis are the most common . PPCs have a significant clinical and economic impact associated with increased observed number of deaths , morbidity , length of stay and associated cost . The aim of this study was to assess the incidence and impact of PPCs and to identify potentially modifiable independent risk factors . Methods A prospect i ve observational study was carried out on all patients following lung resection via thoracotomy in a regional thoracic centre over 13 months . PPC was assessed using a scoring system based on chest x-ray , raised white cell count , fever , microbiology , purulent sputum and oxygen saturations . Results Thirty-four of 234 subjects ( 14.5 % ) had clinical evidence of PPC . The PPC patient group had a significantly longer length of stay ( LOS ) in hospital , high dependency unit ( HDU ) LOS , higher frequency of intensive care unit ( ITU ) admission and a higher number of hospital deaths . Older patients , body mass index ( BMI ) ≥30 kg/m2 , preoperative activity preoperative forced expiratory volume in 1 s ( FEV1 ) and predicted postoperative ( PPO ) FEV1 were all significantly ( p 75 years , BMI ≥30 kg/m2 , ASA ≥3 , smoking history and COPD were significant independent risk factors in the development of PPC ( p<0.05 ) . Conclusion The clinical impact of PPCs is marked . Significant independent preoperative risk factors have been identified in current clinical practice . Potentially modifiable risk factors include BMI , smoking status and COPD . The impact of targeted therapy requires further evaluation",
"Background Systemic inflammation plays an important role in the initiation , promotion , and progression of lung carcinogenesis . In patients with non-small cell lung cancer ( NSCLC ) , fibrinogen levels correlate with neoplasia . Here we compared the effects of pulmonary rehabilitation ( PR ) with chest physical therapy ( CPT ) on fibrinogen and albumin levels in patients with LC and previous inflammatory lung disease awaiting lung resection . Methods We conducted a r and omized clinical trial with 24 patients who were r and omly assigned to Pulmonary Rehabilitation ( PR ) and Chest Physical Therapy ( CPT ) groups . Each group underwent training 5 days weekly for 4 weeks . All patients were assessed before and after four weeks of training through clinical assessment , measurement of fibrinogen and albumin levels , spirometry , 6-minute Walk Test ( 6MWT ) , quality of life survey , and anxiety and depression scale . PR involved strength and endurance training , and CPT involved lung expansion techniques . Both groups attended educational classes . Results A mixed between-within subjects analysis of variance ( ANOVA ) revealed a significant interaction between time ( before and after intervention ) and group ( PR vs. CPT ) on fibrinogen levels ( F(1 , 22 ) = 0.57 , p effect of time ( F(1 , 22 ) = 0.68 , p = 0.004 ) . Changes in albumin levels were not statistically significant relative to the interaction effect between time and group ( F(1 , 22 ) = 0.96 , p = 0.37 ) nor the main effects of time ( F(1 , 22 ) = 1.00 , p = 1.00 ) and group ( F(1 , 22 ) = 0.59 , p = 0.45 ) . A mixed between-within subjects ANOVA revealed significant interaction effects between time and group for the peak work rate of the unsupported upper limb exercise ( F(1 , 22 ) = 0.77 , p = 0.02 ) , endurance time ( F(1 , 22 ) = 0.60 , p = 0.001 ) , levels of anxiety ( F(1 , 22 ) = 0.60 , p = 0.002 ) and depression ( F(1 , 22 ) = 0.74 , p = 0.02 ) , and the SF-36 physical component summary ( F(1 , 22 ) = 0.83 , p = 0.07 ) . Conclusion PR reduced serum fibrinogen levels , improved functional parameters , and quality of life of patients with LC and inflammatory lung disease awaiting lung resection . Trial registration Current Controlled Trials RBR-3nm5bv",
"OBJECTIVES The aim of the study was to develop a multistr and ed pragmatic rehabilitation programme for operable lung cancer patients , that looks into feasibility , process indicators , outcome measures , local adaptability , compliance and potential cost benefit . METHODS An outpatient-based complex intervention , rehabilitation for operated lung cancer ( ROC ) programme , was developed to optimize physical status , prepare for the inpatient journey and support through recovery after surgery . It includes exercise classes , smoking cessation , dietary advice and patient education and was tested in an enriched cohort study within a regional thoracic unit over 18 months . RESULTS A multistr and ed pragmatic rehabilitation programme pre- and post-surgery is feasible . Fifty-eight patients received the intervention and 305 received st and ard care . Both groups were matched for age , lung function comorbidity and type of surgery . Patients in the intervention group attended exercise classes twice a week until surgery , which was not delayed . Patients attended four sessions presurgery ( range 1 - 15 ) , result ing in an improvement of 20 m ( range -73 - 195 , P = 0.001 ) in a 6-min walk test and 0.66 l in forced expiratory volume in 1 s ( range -1.85 from 1.11 , P = 0.009 ) from baseline to presurgery . Fifty-four percentage of smokers in the intervention group stopped smoking . Sixteen percentage of patients were identified as being at risk of malnourishment and received nutritional intervention . There was a trend in patients in the intervention group towards experiencing fewer postoperative pulmonary complications than those in the non-intervention group ( 9 vs 16 % , respectively , P = 0.21 ) and fewer readmissions to hospital because of complications ( 5 vs 14 % respectively , P = 0.12 ) . CONCLUSION Chronic obstructive pulmonary disease-type pulmonary rehabilitation before and after lung cancer surgery is viable , and preliminary results suggest improvement in physical measures . A multicentre , r and omized controlled trial is warranted to confirm clinical efficacy . IS RCT N REGISTRATION NUMBER IS RCT N00061628",
"BACKGROUND A predicted postoperative forced expiratory volume in 1 second ( FEV1 ) of less than 800 ml or 40 % of predicted is a common criterion for exclusion of patients from lung resection for cancer . Usually , the predicted postoperative lung function is calculated according to a formula based on the number of lung segments that will be resected . Incentive spirometry and specific inspiratory muscle training are two maneuvers that have been used to enhance lung expansion and inspiratory muscle strength in patients with chronic obstructive pulmonary disease and after lung operation . METHODS Thirty-two patients with chronic obstructive pulmonary disease who were c and i date s for lung resection were r and omized into two groups : 17 patients received specific inspiratory muscle training and incentive spirometry , 1 hour per day , six times a week , for 2 weeks before and 3 months after lung resection ( group A ) and 15 patients were assigned to the control group and received no training ( group B ) . RESULTS Inspiratory muscle strength increased significantly in the training group , both before and 3 months after the operation . In group B , the predicted postoperative FEV1 value consistently underestimated the actual postoperative FEV1 by approximately 70 ml in the lobectomy subgroup and by 110 ml in the pneumonectomy subgroup . In group A , the actual postoperative FEV1 was higher than the predicted postoperative FEV1 by 570 ml in the lobectomy subgroup and by 680 ml in the pneumonectomy subgroup of patients . CONCLUSIONS In patients undergoing lung resection the simple calculation of predicted postoperative FEV1 underestimates the actual postoperative FEV1 by a small fraction . Lung functions can be increased significantly when incentive spirometry and specific inspiratory muscle training are used before and after operation",
"Introduction Postoperative pulmonary complications ( PPC ) such as atelectasis and pneumonia are common following lung resection . PPCs have a significant clinical impact on postoperative morbidity and mortality . We studied the long-term effects of PPCs and sought to identify independent risk factors . Methods A prospect i ve observational study involved all patients following lung resection in a regional thoracic centre over 4 years . PPCs were assessed daily in hospital using the Melbourne group scale based on chest X-ray , white cell count , fever , purulent sputum , microbiology , oxygen saturations , physician diagnosis and intensive therapy unit (ITU)/high-dependency unit readmission . Follow-up included hospital length of stay ( LOS ) , 30-day readmissions , and mortality . Results 86 of 670 patients ( 13 % ) who had undergone a lung resection developed a PPC . Those patients had a significantly longer hospital LOS in days ( 13 , 95 % CI 10.5–14.9 vs 6.3 , 95 % CI 5.9 to 6.7 ; p higher rates of ITU admissions ( 28 % vs 1.9 % ; p 30-day hospital readmissions ( 20.7 % vs 11.9 % ; p reduced overall survival in months ( 40 , 95 % CI 34 to 44 vs 46 , 95 % CI 44 to 47 ; p=0.006 ) . Those who developed a PPC had a higher rate of non-cancer-related deaths ( 11 % vs 5 % ; p=0.020 ) . PPC is a significant independent risk factor for late deaths in non-small cell lung cancer patients ( HR 2.0 , 95 % CI 1.9 to 3.2 ; p=0.006 ) . Conclusions Developing a PPC after thoracic surgery is common and is associated with a poorer long-term outcome",
"OBJECTIVE This study investigates whether targeted postoperative respiratory physiotherapy decreased the incidence of postoperative pulmonary complications and length of stay for patients undergoing elective pulmonary resection via open thoracotomy . METHODS Seventy-six patients participated in a prospect i ve , single-blind , parallel-group , r and omised trial with concealed allocation , assessor blinding and intention-to-treat analysis . Treatment group participants received daily respiratory physiotherapy interventions until discharge . Control group participants received st and ard medical/nursing care involving a clinical pathway . The presence of postoperative pulmonary complications was assessed on a daily basis during hospitalisation using a st and ardised diagnostic tool . Length of stay was recorded . RESULTS Postoperative pulmonary complications developed in two participants ( 4.8 % ) in the treatment group and in one participant ( 2.9 % ) in the control group ; the difference ( treatment minus control ) was 1.8 % ( 95 % confidence interval ( CI ) -10.6 % to 13.1 % ) ( p=1.00 ) . No significant difference was found between groups for length of stay ( treatment group , median 6.0 days ; control group 6.0 days ) ( p=0.87 ) . A preoperative forced expiratory volume in 1s of 1.5l or less ( p=0.005 ) and a history of chronic obstructive pulmonary disease ( p=0.008 ) were associated with a greater number of criteria for a postoperative pulmonary complication being met . CONCLUSIONS In this patient population , given the low incidence of postoperative pulmonary complications , targeted respiratory physiotherapy may not be required in addition to st and ard care involving a clinical pathway following pulmonary resection via open thoracotomy . These results should be extrapolated with caution to those patients undergoing pulmonary resection with poor preoperative lung function",
"PURPOSE The purpose of this study was to identify the effects of a Progressive Walking program ( PW ) on physical activity , exercise tolerance , recovery , and post-operative complications for patients with a lung resection . METHODS A nonequivalent control group non-synchronized design was utilized and 37 participants with a lung resection ( 22 for control group , 15 for experimental group ) were recruited at A university hospital from December 2012 to August 2013 . The PW consisted of preoperative education , goal setting , and feedback , provided to the experimental group , and usual care to the control group . Data were analyzed using the SPSS WIN 18.0 . RESULTS A higher proportion of patients in the experimental group showed adequate levels of physical activity ( p=.001 ) , shorter period of chest tube retention ( ≤ 7 days ; p=.011 ) , and shorter stay in the hospital ( ≤ 10 days ; p=.036 ) than patients in the control group . Patients in the experimental group reported longer 6-minute walking distance ( p=.032 ) and lower levels of dyspnea ( p=.049 ) than patients in the control group . The PW did not influence the occurrence of pulmonary complications . CONCLUSION The findings of this study suggest that the PW could be a useful strategy for improving patients ' post-operative health and reducing cost after lung resection",
"Introduction : A stepwise approach to the functional assessment of lung resection c and i date s is widely accepted , and this approach incorporates the measurement of exercise peak Vo2 when spirometry and radionuclear studies suggest medical inoperability . A new functional operability ( FO ) algorithm incorporates peak exercise Vo2 earlier in the preoperative assessment to determine which patients require preoperative radionuclear studies . This algorithm has not been studied in a multicenter study . Methods : The CALGB ( Cancer and Leukemia Group B ) performed a prospect i ve multi-institutional study to investigate the use of primary exercise Vo2 measurement for the prediction of surgical risk . Patients with known or suspected resectable non-small cell lung cancer ( NSCLC ) were eligible . Exercise testing including measurement of peak oxygen uptake ( Vo2 ) , spirometry , and single breath diffusion capacity ( DLCO ) was performed on each patient . Nuclear perfusion scans were obtained on selected high-risk patients . After surgery , morbidity and mortality data were collected and correlated with preoperative data . Mortality and morbidity were retrospectively compared by algorithm-based risk groups . Results : Three hundred forty-six patients with suspected lung cancer from nine institutions underwent thoracotomy with or without resection ; 57 study patients did not undergo thoracotomy . Patients who underwent surgery had a median survival time of 30.9 months , whereas patients who did not undergo surgery had a median survival time of 15.6 months . Among the 346 patients who underwent thoracotomy , 15 patients died postoperatively ( 4 % ) , and 138 patients ( 39 % ) exhibited at least one cardiorespiratory complication postoperatively . We found that patients who had a peak exercise Vo2 of complications ( p = 0.0001 ) and were also more likely to have a poor outcome ( respiratory failure or death ) if the peak Vo2 was 58 patients who did not meet FO algorithm criteria for operability , but who still tolerated lung resection with a 2 % mortality rate . Conclusions : Our data provide multicenter validation for the use of exercise Vo2 for preoperative assessment of lung cancer patients , and we encourage an aggressive approach when evaluating these patients for surgery",
"To describe and compare the daily ambulatory activity of the patients before and one month after major lung resection . Daily activity was measured using a pedometer ( OMROM Walking Style PRO ) given preoperatively in a prospect i ve way to a series of 21 consecutive cases scheduled for lobectomy or pneumonectomy . Analyzed variables were age , pulmonary function , mean number of total and aerobic steps per day , walked distance and mean daily time of aerobic activity . Activity variables were analyzed individually and as a new differential variable DELTA . Wilcoxon and Mann-Whitney nonparametric tests were used for comparison between groups . General series data : 19 male . Age : 63+/-10.9 years . FEV(1)% : 88.4+/-22.7 . DLCO : 86.2+/-21.6 . Eleven cases had COPD criteria . Type of surgery : 3 pneumonectomy/18 lobectomy . Activity data : all patients showed a global decrease of their activity one month after surgery but , patients in the pneumonectomy group are unable to keep aerobic activity meanwhile patients that undergone lobectomy showed only a 25 % reduction in the measured variables . Major pulmonary resection decreases the time and the quality of the daily ambulatory activity of the patients during the first postoperative month . Despite limitations , the chosen pedometer OMRON Walking Style Pro is an efficient tool to evaluate the perioperative daily ambulatory activity of patients",
"OBJECTIVE To evaluate the effect of 4 weeks of pulmonary rehabilitation ( PR ) versus chest physical therapy ( CPT ) on the preoperative functional capacity and postoperative respiratory morbidity of patients undergoing lung cancer resection . DESIGN R and omized single-blinded study . SETTING A teaching hospital . PARTICIPANTS Patients undergoing lung cancer resection ( N=24 ) . INTERVENTIONS Patients were r and omly assigned to receive PR ( strength and endurance training ) versus CPT ( breathing exercises for lung expansion ) . Both groups received educational classes . MAIN OUTCOME MEASURES Functional parameters assessed before and after 4 weeks of PR or CPT ( phase 1 ) , and pulmonary complications assessed after lung cancer resection ( phase 2 ) . RESULTS Twelve patients were r and omly assigned to the PR arm and 12 to the CPT arm . Three patients in the CPT arm were not su bmi tted to lung resection because of inoperable cancer . During phase 1 evaluation , most functional parameters in the PR group improved from baseline to 1 month : forced vital capacity ( FVC ) ( 1.47L [ 1.27 - 2.33L ] vs 1.71L [ 1.65 - 2.80L ] , respectively ; P=.02 ) ; percentage of predicted FVC ( FVC% ; 62.5 % [ 49%-71 % ] vs 76 % [ 65%-79.7 % ] , respectively ; P 6-minute walk test ( 425.5±85.3 m vs 475±86.5 m , respectively ; P maximal inspiratory pressure ( 90±45.9cmH(2)O vs 117.5±36.5cmH(2)O , respectively ; P and maximal expiratory pressure ( 79.7±17.1cmH(2)O vs 92.9±21.4cmH(2)O , respectively ; P lower incidence of postoperative respiratory morbidity ( P=.01 ) , a shorter length of postoperative stay ( 12.2±3.6d vs 7.8±4.8d , respectively ; P=.04 ) , and required a chest tube for fewer days ( 7.4±2.6d vs 4.5±2.9d , respectively ; P=.03 ) compared with the CPT arm . CONCLUSIONS These findings suggest that 4 weeks of PR before lung cancer resection improves preoperative functional capacity and decreases the postoperative respiratory morbidity ",
"BACKGROUND We planned to investigate the effect of preoperative short period intensive physical therapy on lung functions , gas-exchange , and capacity of diffusion , and ventilation-perfusion distribution of patients with non-small cell lung cancer . METHODS Sixty patients with lung cancer , who were deemed operable , were r and omly allocated into two groups . Intensive physical therapy was performed in patients in the study group before operation . Both groups received routine physical therapy after operation . RESULTS There was no difference in pulmonary function tests between the two groups . Intensive physical therapy statistically significantly increased peripheral blood oxygen saturation . At least one complication was noted in 5 patients ( 16.7 % ) in the control group , and 2 ( 6.7 % ) , in the study group . However , there was no statistically significant difference ( p = 0,4 ) . The hospital stay has been found to be statistically significantly shortened by intensive physical therapy ( p Ventilation-perfusion distribution was found to be significantly effected by intensive physical therapy . The change was prominent in the the contralateral lung ( p Intensive physical therapy appeared to increase oxygen saturation , reduce hospital stay , and change the ventilation/perfusion distribution . It had a significant , positive effect on the exercise capacity of patients",
"Complete surgical resection is the most effective curative treatment for lung cancer . However , many patients with lung cancer also have severe COPD which increases their risk of postoperative complications and their likelihood of being considered \" inoperable . \" Preoperative pulmonary rehabilitation ( PR ) has been proposed as an intervention to decrease surgical morbidity but there is no established protocol and no r and omized study has been published to date . We tested two preoperative PR interventions in patients undergoing lung cancer resection and with moderate-severe COPD in a r and omized single blinded design . Outcomes were length of hospital stay and postoperative complications . The first study tested 4 weeks of guideline -based PR vs. usual care : that study proved to be very difficult to recruit as patients and providers were reluctant to delay surgery . Nine patients were r and omized and no differences were found between arms . The second study tested ten preoperative PR sessions using a customized protocol with nonst and ard components ( exercise prescription based on self efficacy , inspiratory muscle training , and the practice of slow breathing ) ( n=10 ) vs. usual care ( n=9 ) . The PR arm had shorter length of hospital stay by 3 days ( p=0.058 ) , fewer prolonged chest tubes ( 11 % vs. 63 % , p=0.03 ) and fewer days needing a chest tube ( 8.8 vs. 4.3 days p=0.04 ) compared to the controlled arm . A ten-session preoperative PR intervention may improve post operative lung reexpansion evidence d by shorter chest tube times and decrease the length of hospital stay , a crude estimator of post operative morbidity and costs . Our results suggest the potential for short term preoperative pulmonary rehabilitation interventions in patients with moderate-severe COPD undergoing curative lung resection . 4 weeks of conventional preoperative PR seems non feasible",
"BACKGROUND The objective of this investigation was to assess the association of peak oxygen consumption ( Vo(2 ) ) with postoperative outcome in a prospect i ve cohort of patients undergoing major lung resection for the treatment of lung cancer . METHODS Preoperative symptom-limited cardiopulmonary exercise testing ( CPET ) performed using cycle ergometry was conducted in 204 consecutive patients who had undergone pulmonary lobectomy or pneumonectomy . Peak Vo(2 ) was tested for possible association with postoperative cardiopulmonary complications and mortality . Logistic regression analysis , vali date d by a bootstrap analysis , was used to adjust for the effect of other perioperative factors . The role of peak Vo(2 ) in stratifying the surgical risk was further assessed in different groups of patients subdivided according to their cardiorespiratory status . RESULTS Logistic regression showed that peak Vo(2 ) was an independent and reliable predictor of pulmonary complications ( p = 0.04 ) . All six deaths occurred in patients with a peak Vo(2 ) of mortality rate in this high-risk group was 10-fold higher ( 4 of 30 patients ; 13 % ) compared to those with higher peak Vo(2 ) ( p = 0.006 ) . Compared to patients with a peak Vo(2 ) of > 20 mL/kg/min , those with a peak Vo(2 ) of total cardiopulmonary complications pulmonary complications , cardiac complications , and mortality . CONCLUSIONS The present study supports a more liberal use of CPET before lung resection compared to the current guidelines since this test can help in stratifying the surgical risk and optimizing perioperative care",
"OBJECTIVES Peak VO2 , as measure of physical performance is central to a correct preoperative evaluation in patients with both non-small-cell lung cancer ( NSCLC ) and chronic obstructive pulmonary disease ( COPD ) because it is closely related both to operability criteria and the rate of postoperative complications . Strategies to improve peak VO2 , as a preoperative pulmonary rehabilitation programme ( PRP ) , should be considered favourably in these patients . In order to clarify the role of pulmonary rehabilitation , we have evaluated the effects of 3-week preoperative high-intensity training on physical performance and respiratory function in a group of patients with both NSCLC and COPD who underwent lobectomy . METHODS We studied 40 patients with both NSCLC and COPD , age Patients were r and omly divided into two groups ( R and S ) : Group R underwent an intensive preoperative PRP , while Group S underwent only lobectomy . We evaluated peak VO2 in all patients at Time 0 ( T0 ) , after PRP/before surgery in Group R/S ( T1 ) and 60 days after surgery , respectively , in both groups ( T2 ) . RESULTS There was no difference between groups in peak VO2 at T0 , while a significant difference was observed both at T1 and T2 . In Group R , peak VO2 improves significantly from T0 to T1 : 14.9 ± 2.3 - 17.8 ± 2.1 ml/kg/min ± st and ard deviation ( SD ) , P S peak VO2 did not change from T0 to T1 and significantly deteriorates from T1 to T2 : 14.5 ± 1.2 - 11.4 ± 1.2 ml/kg/min ± SD , P CONCLUSIONS PRP was a valid preoperative strategy to improve physical performance in patients with both NSCLC and COPD and this advantage was also maintained after surgery",
"BACKGROUND The number of cancer survivors is increasing rapidly ; however , little is known about whether engaging in physical activity after a cancer diagnosis is associated with lower mortality rates in men . METHODS We conducted a prospect i ve cohort study of 1021 men ( mean age , 71.3 years ) who were diagnosed with cancer ( other than nonmelanoma skin cancer ) . Men reported their physical activities ( walking , stair climbing , and participation in sports and recreational activities ) on question naires in 1988 , a median of 6 years after their cancer diagnosis . Physical activity was up date d in 1993 and men were followed until 2008 , with mortality follow-up > 99 % complete , during which 777 men died ( 337 from cancer , 190 from cardiovascular disease ) . RESULTS In multivariate analyses , the relative risks for all-cause mortality associated with expending in physical activity were 1.00 ( referent ) , 0.77 , 0.74 , 0.76 , and 0.52 , respectively ( P-trend levels of physical activity also were associated with lower rates of death from cancer and cardiovascular disease ( P- trend = 0.01 and 0.002 , respectively ) . CONCLUSIONS Engaging in physical activity after cancer diagnosis is associated with better survival among men",
"BACKGROUND As a newly developed treatment , preoperative pulmonary rehabilitation ( PR ) has been studied in depth . However , few studies have assessed the relationship between advanced age and a shorter term intensive pattern of preoperative PR in patients with lung cancer ( LC ) and especially those patients waiting for therapeutic LC surgeries . This study investigated short-term preoperative PR combined with inspiratory muscle training ( IMT ) and aerobic endurance training in elderly patients scheduled to undergo LC lobectomy . METHODS A prospect i ve r and omized controlled trial with a total of 60 subjects aged ≥70 y was conducted . The intervention group ( PR group ) was treated for 1 wk with systematic and highly intensive preoperative PR training before lobectomy , and the control group ( NPR group ) was treated with conventional preoperative respiratory management . We analyzed the 6-min walking distance ( 6-MWD ) , the peak expiratory flow ( PEF ) , and quality -of-life scores before and after the rehabilitation regimen as well as the incidence of postoperative pulmonary complications ( PPCs ) . RESULTS In total , 30 patients ( PR group ) completely executed the 7-d intensive preoperative PR , and 30 patients ( NPR group ) served as the control group . The two groups were comparable at baseline . During the preoperative PR , a significantly longer 6-MWD ( increase : 28.6 ± 18.2 versus 9.4 ± 27.0 m ; between-groups difference : 19.2 m , P = 0.029 ) and an increased PEF ( increase : 26.2 ± 22.5 versus 8.2 ± 10.3 L/min ; between-groups difference : 18.0 L/min , P the mean postoperative length of stay ( 6.9 ± 4.4 versus 10.7 ± 6.4 d , P = 0.010 ) and total hospital stay ( 16.0 ± 4.5 versus 19.7 ± 6.5 d , P = 0.012 ) were significantly reduced in the PR group . Thirty-day PPCs were noted in four ( 13.3 % ) patients in the PR group and 11 ( 36.7 % ) patients in the NPR group , with a significant difference between the two groups ( P = 0.037 ) . CONCLUSIONS For elderly LC patients scheduled to undergo surgery in China , a 7-d intensive pattern of preoperative PR combined with IMT and aerobic endurance training may be a feasible rehabilitation strategy with positive physical and psychological effects",
"Introduction . Surgical resection in patients with non – small cell lung cancer ( NSCLC ) may be associated with significant morbidity , functional limitations , and decreased quality of life . Objectives . The safety and feasibility of a preoperative and early postoperative rehabilitation program in patients operated for NSCLC was determined in a nonhospital setting , with focus on high-intensity interval exercise . Methods . Forty patients with biopsy-proven NSCLC stages I to IIIa referred for surgical resection at the Department of Cardiothoracic Surgery RT , Rigshospitalet , University of Copenhagen , were r and omly assigned to 1 of 4 groups ( 3 intervention groups and 1 control group ) . The preoperative intervention consisted of a home-based exercise program , while the postoperative exercise program comprised a supervised group exercise program involving resistance and high-intensity interval cardiorespiratory exercise 2 hours weekly for 12 weeks combined with individual counseling . The study endpoints were inclusion rate , adherence , and number of adverse events . Results . Forty patients ( of 124 screened ; 32 % ) were included and r and omized into the 4 groups . The postoperative exercise was completed by 73 % of the patients r and omized to this intervention . No adverse events were observed , indicating that the early postoperative exercise program is safe . The preoperative home-based exercise program was not feasible due to interfering diagnostic procedures and fast-track surgery that left only 1 to 2 weeks between diagnosis and surgery . Conclusion . The early postoperative exercise program for patients with NSCLC was safe and feasible , but in a fast-track set up , a preoperative home-based exercise program was not feasible for this population"
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41182b92-06ff-11f0-808a-c43d1ab1c353
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