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INTRODUCTION Pain is a frequent clinical symptom with significant impact on the patient 's well-being . Therefore , adequate pain management is of utmost importance . While cannabinoids have become a more popular alternative to traditional types of pain medication among patients , the quality of evidence supporting the use of cannabinoids has been question ed . The beneficial and harmful effects of cannabinoids in patients with pain is unknown . Accordingly , we aim to assess the efficacy , tolerability and safety of cannabinoids ( herbal , plant-derived extracts and synthetic ) compared with placebo or no intervention for any type of pain . METHODS AND ANALYSES We will conduct a systematic review of r and omised clinical trials with meta- analysis and Trial Sequential Analysis to assess the beneficial and harmful effects of cannabinoids in any dose , formulation and duration . We will accept placebo or no treatment as control interventions . We will include participants with any type of pain ( acute and chronic pain , cancer-related pain , headache , neuropathic pain or any other types of pain ) . We will systematic ally search The Cochrane Library , MEDLINE , Embase , Science Citation Index and BIOSIS for relevant literature . We will follow the recommendations by Cochrane and the Preferred Reporting Items for Systematic Review and Meta- Analysis statement . The risk of systematic errors ( bias ) and r and om errors ( play of chance ) will be assessed . The overall certainty of evidence will be evaluated using the Grading of Recommendations Assessment , Development and Evaluation approach . ETHICS AND DISSEMINATION Ethical approval is not a requirement since no primary data will be collected . The findings of this systematic review will be su bmi tted for peer- review ed publication and disseminated in national and international conferences . DISCUSSION Although cannabinoids are now being used to manage different pain conditions , the evidence for the clinical effects are unclear . The present review will systematic ally assess the current evidence for the benefits and harms of cannabinoids to inform practice and future research
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"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",
"OBJECTIVES The present study assessed changes in the Medical Outcomes Study 36-item short-form health survey ( SF-36 ) during a 12-month period and examined the relation of those changes to selected baseline characteristics . METHODS The study was a 12-month follow-up evaluation of 786 disadvantaged adults aged 50 to 99 years old who had participated in a r and omized controlled clinical trial in the general medicine outpatient clinics of a major academic medical center . Descriptive and psychometric analyses of changes in the SF-36 scale scores during a 12-month period were performed , and two series of multivariable logistic regressions of increases or decreases greater than one st and ard error of measurement ( SEM ) versus stability on selected baseline characteristics were done . Measures were the eight SF-36 scales . RESULTS Mean baseline scores on the SF-36 scales were substantially below age-specific national norms . Problematic floor and /or ceiling effects were found for the bodily pain , social function , role -- physical , and role -- emotional scales , consistent with age-specific national norms . Internal consistency was unacceptable for the general health perceptions scale , adequate for the social function scale , and good for all the other SF-36 scales . Improvements greater than one st and ard error of measurement were found for between one fifth and one third of the patients , and declines greater than one st and ard error of measurement were found for between one fifth and one third of the patients . Selected baseline characteristics generally were unrelated to either improvements or declines on the SF-36 scales . CONCLUSIONS The SF-36 scales appear to be sufficiently sensitive for measuring changes in health outcomes during a 1-year period in older patients with debilitating disease . Little of the measured change , however , was predictable",
"Study Design . Cohort study . Objectives . To estimate the Minimal Clinical ly Important Change ( MCIC ) of the pain intensity numerical rating scale ( PI-NRS ) , the Quebec Back Pain Disability Scale ( QBPDS ) , and the Euroqol ( EQ ) in patients with low back pain . Summary of Background Data . MCIC can provide valuable information for research ers , healthcare providers , and policymakers . Methods . Data from a r and omized controlled trial with 442 patients with low back pain were used . The MCIC was estimated over a 12-week period , and three different methods were used : 1 ) mean change scores , 2 ) minimal detectable change , and 3 ) optimal cutoff point in receiver operant curves . The global perceived effect scale ( GPE ) was used as an external criterion . The effect of initial scores on the MCIC was also assessed . Results . The MCIC of the PI-NRS ranged from 3.5 to 4.7 points in (sub)acute patients and 2.5 to 4.5 points in chronic patients with low back pain . The MCIC of the QBPDS was estimated between 17.5 to 32.9 points and 8.5 to 24.6 points for (sub)acute and chronic patients with low back pain . The MCIC for the EQ ranged from 0.07 to 0.58 in (sub)acute patients and 0.09 to 0.28 in patients with chronic low back pain . Conclusion . Reporting the percentage of patients who have made a MCIC adds to the interpretability of study results . We present a range of MCIC values and advocate the choice of a single MCIC value according to the specific context",
"Meta-analyses indicate that antidepressants are superior to placebos in statistical terms , but the clinical relevance of the differences has not been established . Previous suggestions of clinical ly relevant effect sizes have not been supported by empirical evidence . In the current paper we apply an empirical method that consists of comparing scores obtained on the Hamilton rating scale for depression ( HAM-D ) and scores from the Clinical Global Impressions-Improvement ( CGI-I ) scale . This method reveals that a HAM-D difference of 3 points is undetectable by clinicians using the CGI-I scale . A difference of 7 points on the HAM-D , or an effect size of 0.875 , is required to correspond to a rating of ' minimal improvement ' on the CGI-I. By these criteria differences between antidepressants and placebo in r and omised controlled trials , including trials conducted with people diagnosed with very severe depression , are not detectable by clinicians and fall far short of levels consistent with clinical ly observable minimal levels of improvement . Clinical significance should be considered alongside statistical significance when making decisions about the approval and use of medications like antidepressants"
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41173994-06ff-11f0-808a-c43d1ab1c353
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PURPOSE The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of Peyronie 's disease . MATERIAL S AND METHODS A systematic review of the literature using the PubMed ® , EMBASE ® and Cochrane data bases ( search date s 1/1/1965 to 1/26/15 ) was conducted to identify peer- review ed publications relevant to the diagnosis and treatment of PD . The review yielded an evidence base of 303 articles after application of inclusion /exclusion criteria . RESULTS The systematic review was used to create guideline statements regarding treatment of PD . When sufficient evidence existed , the body of evidence for a particular treatment was assigned a strength rating of A ( high quality evidence ; high certainty ) , B ( moderate quality evidence ; moderate certainty ) , or C ( low quality evidence ; low certainty ) . Evidence -based statements of Strong , Moderate , or Conditional Recommendation were developed based on benefits and risks/burdens to patients . Additional consensus statements related to the diagnosis of PD are provided as Clinical Principles and Expert Opinions due to insufficient published evidence . CONCLUSIONS There is a continually exp and ing literature on PD ; the Panel notes that this document constitutes a clinical strategy and is not intended to be interpreted rigidly . The most effective approach for a particular patient is best determined by the individual clinician and patient in the context of that patient 's history , values , and goals for treatment . As the science relevant to PD evolves and improves , the strategies presented here will be amended to remain consistent with the highest st and ards of clinical care
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"INTRODUCTION Extracorporeal shock wave therapy ( ESWT ) for treatment of Peyronie 's disease ( PD ) is controversial . AIM To study the efficacy of ESWT by a placebo-controlled , r and omized trial . METHODS Patients with PD ( n=102 ) were r and omly assigned ( n=51 ) to each group ( ESWT or placebo ) . All patients were given 6 weekly treatments . Patients in the ESWT-group received 2,000 shock waves per session , using the Piezoson 100 lithotripter ( Richard Wolf , Knittlingen , Germany ) . Patients in the placebo-group were treated with interposition of a plastic membrane , which prevented any transmission of shock waves . MAIN OUTCOME MEASURES Primary end point was decrease of pain between baseline and after 4 weeks follow-up . Secondary end points were changes in deviation , plaque size , and sexual function . Pain was assessed by a visual analog scale . Deviation was measured by a goniometer after artificial erection using Alprostadil ( Viridal ® , Schwarz Pharma , Monheim , Germany ) . Plaque size was measured with a ruler and sexual function assessed by a scale regarding the ability to perform sexual intercourse . RESULTS Overall , only 45 patients experienced pain at baseline . In the subgroup analysis of these patients , pain decreased in 17/20 ( 85.0 % ) patients in the ESWT group and 12/25 ( 48.0 % ) patients in the placebo group ( P=0.013 , relative risk [RR]=0.29 , 95 % confidence interval : 0.09 - 0.87 ) . Penile deviation was not reduced by ESWT ( P=0.66 ) but worsened in 20/50 ( 40 % ) and 12/49 ( 24.5 % ) patients of the ESWT and placebo-group , respectively ( P=0.133 ) . Plaque size reduction was not different between the two groups ( P=0.33 ) . Additional , plaque size increased in five patients ( 10.9 % ) of the ESWT group only . An improvement in sexual function could not be verified ( P=0.126 , RR=0.46 ) . CONCLUSIONS Despite some potential benefit of ESWT in regard to pain reduction , it should be emphasized that pain usually resolves spontaneously with time . Given this and the fact that deviation may worsen with ESWT , this treatment can not be recommended",
"PURPOSE We investigated the efficacy and safety of intralesional interferon alpha-2b for the treatment of Peyronie 's disease . MATERIAL S AND METHODS A total of 117 consecutive patients with a mean age of 55.1 years who had Peyronie 's disease were enrolled in a single-blind , multicenter , placebo controlled , parallel study to determine the efficacy and safety of intralesional interferon alpha-2b therapy ( Schering , Kenilworth , New Jersey ) , including 62 who received placebo and 55 who received interferon alpha-2b . Saline ( 10 ml ) in controls and interferon alpha-2b ( 5 x 10(6 ) U ) were administered biweekly for 12 weeks . Each patient was evaluated for penile curvature , plaque size and density , penile pain , erectile function and penile hemodynamics before and after study completion . Improvement in these parameters was statistically compared between the groups . RESULTS A total of 53 patients in the control arm and 50 in the interferon alpha-2b arm completed the study . Improvement in penile curvature , plaque size and density , and pain resolution was significantly greater in patients treated with interferon alpha-2b vs placebo . The increase in mean International Index of Erectile Function scores was not significantly different between the groups . Penile blood flow improvement was observed in interferon alpha-2b treated patients but not in those who received placebo . The decrease in the number of penile vascular pathologies was significantly higher in interferon alpha-2b cases . Side effects , mostly flu-like symptoms , which were frequently noted in patients on interferon alpha-2b , were mild to moderate in degree and of short duration . CONCLUSIONS This single-blind , multicenter , placebo controlled , parallel study demonstrates that intralesional interferon alpha-2b at a dose of 5 x 10(6 ) units biweekly for 12 weeks is effective and safe as minimally invasive therapy for Peyronie 's disease",
"BACKGROUND Extracorporeal shock wave therapy ( ESWT ) is a conservative therapy for patients with Peyronie 's disease ( PD ) . OBJECTIVE To investigate the effects of ESWT in patients with PD . DESIGN , SETTING , AND PARTICIPANTS One hundred patients with a history of PD not > 12 mo who had not had previous PD-related treatments were enrolled in a prospect i ve , r and omized , double-blind , placebo-controlled study . Patients were r and omly allocated to either ESWT ( n=50 ) or placebo ( n=50 ) . Erectile function ( EF ) , pain during erection , plaque size , penile curvature , and quality of life ( QoL ) were assessed at baseline , at 12 wk , and at 24 wk follow-up . INTERVENTION Four weekly treatment sessions were administered . Each ESWT session consisted of 2000 focused shock waves . For the placebo group , a nonfunctioning transducer was employed . MEASUREMENTS EF was evaluated with the shortened version of the International Index of Erectile Function ( IIEF-5 ) , pain was evaluated with a visual analog scale ( VAS ; 0 - 10 ) , plaque size was measured in cm(2 ) , and penile curvature was measured in degrees . RESULTS AND LIMITATIONS After 12 wk , mean VAS score , mean IIEF-5 score , and mean QoL score ameliorated significantly in patients receiving ESWT . Mean plaque size and mean curvature degree were unchanged in the ESWT group , while a slight increase was reported in the placebo group ( p-value not significant vs baseline ) . After 24 wk , mean IIEF-5 score and mean QoL score were stable in the ESWT group , while mean VAS score was significantly lower when compared with baseline in both groups . Interestingly , after 24 wk , mean plaque size and mean curvature degree were significantly higher in the placebo group when compared with both baseline and ESWT values . The main limitations were that the QoL question naire was not vali date d , ED was not etiologically characterized , and inclusion criteria were restricted . CONCLUSIONS In patients with PD , ESWT leads to pain resolution and ameliorates both EF and",
"OBJECTIVES To compare the efficacy and safety of intralesional interferon-alpha 2b combined with oral vitamin E or intralesional interferon-alpha 2b alone or oral vitamin E alone for the treatment of Peyronie 's disease . METHODS From January 2000 to March 2002 , a total of 30 consecutive men with Peyronie 's disease were r and omized prospect ively into three different treatment groups . All the patients were assessed objective ly with penile duplex Doppler ultrasonography for plaque size , location , and presence of calcification before and after treatment . Subjective data were obtained by querying about the improvement in penile pain and by using the \" global efficacy question \" for the assessment of the quality of sexual intercourse at the end of the study . A total of 5.0 x 10(6 ) U of interferon-alpha 2b was given once per week directly into the plaque for a period of 12 weeks . Patients received 400 IU of vitamin E orally twice daily for 6 months . RESULTS At the 6-month follow-up visit , we did not find any statistically significant changes in the objective parameters when compared with the initial findings in each group or among the three groups ( P > 0.05 ) . We did not observe any clinical ly significant improvement in the subjective parameters among the three groups ( P > 0.05 ) . However , all patients who were treated with interferon-alpha 2b experienced brief flu-like side effects . CONCLUSIONS Our findings indicate that 5 million units of intralesional interferon-alpha 2b injection therapy either alone or in combination with vitamin E does not appear to be clinical ly effective in the management of early stage Peyronie 's disease compared with only oral vitamin",
"Extracorporeal shock wave therapy improves erectile function in patients with Peyronie 's disease . However , erectile dysfunction still persists in many cases . We aim ed to investigate the effects of extracorporeal shock wave therapy plus tadalafil 5 mg once daily in the management of patients with Peyronie 's disease and erectile dysfunction not previously treated . One hundred patients were enrolled in a prospect i ve , r and omized , controlled study . Patients were r and omly allocated to receive either extracorporeal shock wave therapy alone for 4 weeks ( n = 50 ) or extracorporeal shock wave therapy plus tadalafil 5 mg once daily for 4 weeks ( n = 50 ) . Main outcome measures were : erectile function ( evaluated through the shortened version of the International Index of Erectile Function ) , pain during erection ( evaluated through a Visual Analog Scale ) , plaque size , penile curvature and quality of life ( evaluated through an internal question naire ) . Follow-up evaluations were performed after 12 and 24 weeks . In both groups , at 12 weeks follow-up , mean Visual Analog Scale score , mean International Index of Erectile Function score and mean quality of life score ameliorated significantly while mean plaque size and mean curvature degree were unchanged . Intergroup analysis revealed a significantly higher mean International Index of Erectile Function score and quality of life score in patients receiving the combination . After 24 weeks , intergroup analysis revealed a significantly higher mean International Index of Erectile Function score and mean quality of life score in patients that received extracorporeal shock wave therapy plus tadalafil . In conclusion extracorporeal shock wave therapy plus tadalafil 5 mg once daily may represent a valid conservative strategy for the management of patients with Peyronie 's disease and erectile dysfunction",
"PURPOSE While surgery remains the gold st and ard of therapy to correct the acquired curvature of Peyronie 's disease , the search for a less invasive therapy continues . Transdermal drug delivery was proposed to be superior to oral or injection therapy because it bypasses hepatic metabolism and minimizes the pain of injection . After electromotive drug administration with verapamil tunica albuginea specimens were demonstrated to contain detectable levels of the drug . Due to varying success with verapamil as injectable therapy for Peyronie 's disease we performed a double-blind , placebo controlled trial to determine the effectiveness of verapamil delivered through electromotive drug administration . MATERIAL S AND METHODS A total of 42 men with Peyronie 's disease volunteered to participate in this study , which was approved by our institutional review board . A genitourinary examination was performed on all patients , including plaque location , stretched penile length , objective measurement of curvature after papaverine injection and duplex ultrasound . Each subject was r and omized to receive 10 mg verapamil in 4 cc saline or 4 cc saline via electromotive drug administration . A Mini-Physionizer ( Physion , Mir and ola , Italy ) device was used at a power of 2.4 mA for 20 minutes . Treatments were performed 2 times weekly for 3 months . After 3 months each patient was reevaluated with physical examination and duplex ultrasound by a technician blinded to the treatment received . A modified erectile dysfunction index of treatment satisfaction question naire was also completed by each patient . RESULTS A total of 23 patients were r and omized to the verapamil treatment group ( group 1 ) and 19 were r and omized to the saline group ( group 2 ) . There were no significant differences between patient groups with respect to patient age , disease duration or pretreatment curvature . In group 1 , 15 patients ( 65 % ) had measured improvement ( mean 9.1 degrees , range 5 to 30 ) , 5 ( 22 % ) had no change and in 3 ( 13 % ) the condition worsened . In group 2 , 11 patients ( 58 % ) had measured improvement ( mean 7.6 degrees , range 5 to 30 ) , 7 ( 37 % ) showed no change and in 1 ( 5 % ) the condition worsened . To better evaluate effectiveness the total number of patients experiencing significant improvement ( 20 degrees or greater ) was calculated and compared . Seven patients ( 30 % ) in group 1 and 4 ( 21 % ) in group 2 achieved this criterion . Although a greater percent of patients treated with verapamil had improved curvature , the results were not statistically significant . CONCLUSIONS Although a greater percent of patients treated with verapamil in our electromotive drug administration protocol had a measured decrease in curvature , the results were not statistically significant . Further research is necessary to determine whether electric current may have a role in the treatment of Peyronie 's disease as well as if verapamil delivered via electromotive drug administration may have a role as effective treatment . Electromotive drug administration is a treatment option in the patient whose major complaint is pain or in the patient with mild curvature who does not wish to undergo intralesional therapy or surgical correction",
"INTRODUCTION Penile duplex Doppler ultrasound ( PDDU ) is currently the preferred method for the functional evaluation of penile hemodynamics . PDDU may be used to monitor objective ly changes in penile vascular parameters in men who undergo treatment for Peyronie 's disease ( PD ) , including intralesional interferon alpha-2b ( IFN alpha-2b ) . AIM To investigate the impact of intralesional IFN alpha-2b therapy for PD on penile hemodynamics by using PDDU and to assess the objective role of PDDU in monitoring treatment outcomes . MATERIAL S AND METHODS Thirty-nine patients ( 20 in the placebo and 19 in the IFN alpha-2b treatment arm ) were enrolled in this prospect i ve , placebo-controlled , parallel study . Patients received either 10 mL saline or 5 x 10(6 ) units of IFN alpha-2b intralesional injections every other week for a total of six injections . Patients in each group were evaluated at baseline and after completion of treatment regarding changes in penile hemodynamic parameters , penile curvature , plaque size and density , pain on erection , and erectile function . Specific published criteria were used for PDDU measurements . Outcomes were statistically compared between each group by using Mann-Whitney U and chi-square tests . RESULTS The mean age of the patients and the duration of PD were similar in both groups . The improvement in penile blood flow was significantly greater in IFN alpha-2b-treated patients than those in the placebo group . The number with the nonvascular classification increased significantly in the IFN alpha-2b arm from 31.5 % to 57.8 % . Additionally , improvements in penile curvature , plaque size and density , and pain on erection were better in the IFN alpha-2b group compared with the control . No significant improvement was observed in the erectile function domain in either group . CONCLUSION This study reveals that intralesional IFN alpha-2b injections have a significant benefit on penile hemodynamic parameters . Moreover , intralesional IFN alpha-2b is an effective , minimally invasive treatment for PD , and PDDU is a useful adjunct to monitor objective ly changes in penile vascular parameters . interferon alpha-2b injection therapy on penile hemodynamics in men with Peyronie 's disease"
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411739d0-06ff-11f0-808a-c43d1ab1c353
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I n the wake of serious health concerns raised by the Women ’s Health Initiative and Heart and Estrogen/ progestin Replacement Study clinical trials , prescriptions for hormone therapy have declined dramatically , leaving many women without effective treatment for menopausal symptoms . Several nonhormonal pharmacologic therapies have shown promise for reducing vasomotor symptoms , including selective serotonin reuptake inhibitors , gabapentin , and clonidine . However , most are only modestly effective , and all have side effects that may limit their use . A number of herbal therapies are marketed to women as being safe and effective in reducing menopausal symptoms , including phytoestrogens , black cohosh , dong quai , evening primrose oil , and red clover . Yet , systematic review s of r and omized , controlled trials found that most were ineffective and these review s raised several concerns about the inadequacy of safety data on botanical supplements . Still , interest in nonhormonal and particularly in complementary and alternative medicine ( CAM ) therapies for menopausal symptoms remains strong . A recent cross-sectional analysis in the multiethnic Study of Women ’s Health Across the Nation found that 53 % of the participants used some form of CAM ( excluding diet , vitamins , exercise , and prayer ) and that rates of use generally did not vary by menopausal status or by presence of vasomotor symptoms . In a survey of 1,296 Australian women with menopausal symptoms , 54 % reported using CAM within the past year for the treatment of menopausal symptoms . In the continued search for a safe and effective CAM therapy for menopausal symptoms , behavioral interventions , such as yoga or paced breathing , are attractive options because they would not carry the potential risks of pharmacologic or botanical therapies . Yoga is an ancient Indian practice that involves the use of movement , postures , breathing techniques , and meditation . The term yoga is derived from the Sanskrit term yuj , meaning Bto yoke^ or Bto unite,^ and the goal of yoga has been described as uniting the body and mind to achieve enlightenment . Yoga has become increasingly popular outside of India , with a 2008 survey of 5,050 people estimating that 7 % of US adults practice yoga . Clinical trials have also demonstrated many potential health benefits of yoga , including reductions in blood pressure , dyslipidemia , and insulin resistance . Although the exact mechanisms of hot flashes remain unknown , physiologic studies have demonstrated that heightened sympathetic nervous system activity plays an important role . Small uncontrolled studies have shown that yoga increases heart rate variability and decreases oxygen consumption , heart rate , and blood pressure , all indicative of decreased sympathetic activity . In addition to its biological effects , yoga may also have beneficial psychological effects that could lead women to find physical symptoms less bothersome and /or help them to cope better with changes during menopause . In this issue of Menopause , Chattha and colleagues report results from one of the largest published trials of yoga for menopausal symptoms . The authors r and omized 120 Indian women with menopausal symptoms to an integrated yoga program or a physical activity control intervention for five 60-minute sessions per week over 8 weeks . The yoga program involved physical postures , breathing techniques , meditation , and lectures , and the control intervention included simple physical exercises ( stretching , brisk walking ) and lectures . The authors found significant improvements in the yoga versus control group in vasomotor symptoms ( P G 0.05 ) and a trend toward improvement in psychological symptoms ( P = 0.06 ) , both measured with the Greene Climacteric Scale . The yoga group also had significantly reduced perceived stress ( P G 0.001 ) and neuroticism ( P G 0.05 ) compared with the control group . Strengths of the study include its relatively large sample size and the carefully design ed control intervention . Limitations include concerns about reproducibility and feasibility outside the study setting . Despite the increasing popularity of yoga , a yoga intervention requiring 60 minutes of supervised instruction five times per week may not be practical for many Western women . The racial/ethnic homogeneity of the sample and the exclusion of women with hypertension , diabetes , and thyroid disease , which are common conditions in peri and postmenopausal women , also limit the generalizability of the study findings . In addition , participants could not be blinded to intervention assignment , and the main outcomes were question naires rather than hot flash diaries or objective measures . Thus , some of the self-reported improvements may have been due to biased outcome reporting . Previous published studies of yoga for menopausal symptoms include two uncontrolled pilot trials and one three-arm , r and omized , controlled trial . A pilot trial of an 8-week restorative yoga intervention ( weekly 90-minute classes plus recommended home practice ) in 14 women with moderate to severe hot flashes found approximately 30 % reductions in hot flash frequency ( P = 0.003 ) and severity ( P = 0.02 ) as measured by 7-day diaries . Significant improvements were also found in sleep quality ( P = 0.02 ) and
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"Background : Many women experience detriments in mental health during the menopausal transition . Physical activity may attenuate these adverse outcomes but few studies investigating such effects exist . Purpose : This study examined the effects of a 4-month r and omized controlled exercise trial on mental health outcomes in 164 previously low-active middle-aged women ( M age=49.9 ; SD=3.6 ) . Methods and Results : Participants completed body composition and fitness assessment and a battery of psychological measures at the beginning and end of a 4-month r and omized controlled exercise trial with three arms : walking , yoga , control . The results indicated that walking and yoga were effective in enhancing positive affect and menopause-related QOL and reducing negative affect . Women who experienced decreases in menopausal symptoms across the trial also experienced improvements in all positive mental health and QOL outcomes and reductions in negative mental health outcomes . Whether menopausal symptoms increased or decreased across the trial appeared to be determined in part by whether there were increases or decreases in cardiorespiratory fitness . Conclusions : Physical activity appears to enhance mood and menopause-related QOL during menopause , however , other aspects of mental health may be affected only as a result of reduction in menopausal symptoms . Increasing cardiorespiratory fitness could be one way to reduce menopausal symptoms",
"CONTEXT The Heart and Estrogen/progestin Replacement Study ( HERS ) found no overall reduction in risk of coronary heart disease ( CHD ) events among postmenopausal women with CHD . However , in the hormone group , findings did suggest a higher risk of CHD events during the first year , and a decreased risk during years 3 to 5 . OBJECTIVE To determine if the risk reduction observed in the later years of HERS persisted and result ed in an overall reduced risk of CHD events with additional years of follow-up . DESIGN AND SETTING R and omized , blinded , placebo-controlled trial of 4.1 years ' duration ( HERS ) and subsequent unblinded follow-up for 2.7 years ( HERS II ) conducted at outpatient and community setting s at 20 US clinical centers . PARTICIPANTS A total of 2763 postmenopausal women with CHD and average age of 67 years at enrollment in HERS ; 2321 women ( 93 % of those surviving ) consented to follow-up in HERS II . INTERVENTION Participants were r and omly assigned to receive 0.625 mg/d of conjugated estrogens and 2.5 mg of medroxyprogesterone acetate ( n = 1380 ) , or placebo ( n = 1383 ) during HERS ; open-label hormone therapy was prescribed at personal physicians ' discretion during HERS II . The proportions with at least 80 % adherence to hormones declined from 81 % ( year 1 ) to 45 % ( year 6 ) in the hormone group , and increased from 0 % ( year 1 ) to 8 % ( year 6 ) in the placebo group . MAIN OUTCOME MEASURES The primary outcome was nonfatal myocardial infa rct ion and CHD death . Secondary cardiovascular events were coronary revascularization , hospitalization for unstable angina or congestive heart failure , nonfatal ventricular arrhythmia , sudden death , stroke or transient ischemic attack , and peripheral arterial disease . RESULTS There were no significant decreases in rates of primary CHD events or secondary cardiovascular events among women assigned to the hormone group compared with the placebo group in HERS , HERS II , or overall . The unadjusted relative hazard ( RH ) for CHD events in HERS was 0.99 ( 95 % confidence interval [ CI ] , 0.81 - 1.22 ) ; HERS II , 1.00 ( 95 % CI , 0.77 - 1.29 ) ; and overall , 0.99 ( 0.84 - 1.17 ) . The overall RHs were similar after adjustment for potential confounders and differential use of statins between treatment groups ( RH , 0.97 ; 95 % CI , 0.82 - 1.14 ) , and in analyses restricted to women who were adherent to r and omized treatment assignment ( RH , 0.96 ; 95 % CI , 0.77 - 1.19 ) . CONCLUSIONS Lower rates of CHD events among women in the hormone group in the final years of HERS did not persist during additional years of follow-up . After 6.8 years , hormone therapy did not reduce risk of cardiovascular events in women with CHD . Postmenopausal hormone therapy should not be used to reduce risk for CHD events in women with CHD",
"OBJECTIVE To determine the feasibility and acceptability of a restorative yoga intervention for the treatment of hot flushes in postmenopausal women . METHODS A pilot trial in 14 postmenopausal women experiencing > or = 4 moderate to severe hot flushes per day or > or = 30 moderate to severe hot flushes per week . The intervention consisted of eight restorative yoga poses taught in a 3-h introductory session and 8 weekly 90-min sessions . Feasibility was measured by recruitment rates , subject retention and adherence . Acceptability was assessed by subject interview and question naires . Efficacy measures included change in frequency and severity of hot flushes as recorded on a 7-day diary . RESULTS Recruitment was accomplished as planned . The majority of study subjects ( 93 % ) completed the trial . Of those who completed the trial , 92 % attended seven or more of the eight yoga sessions . The majority of the subjects were satisfied with the study and 75 % continued to practice yoga 3 months after the study . Mean number of hot flushes per week decreased by 30.8 % ( 95 % CI 15.6 - 45.9 % ) and mean hot flush score decreased 34.2 % ( 95 % CI 16.0 - 52.5 % ) from baseline to week 8 . No adverse events were observed . CONCLUSIONS This pilot trial demonstrates that it is feasible to teach restorative yoga to middle-aged women without prior yoga experience . The high rates of subject retention and satisfaction suggest that yoga is an acceptable intervention in this population . Our results indicate that a larger , r and omized controlled trial to explore the efficacy of restorative yoga for treatment of menopausal symptoms would be safe and feasible",
"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",
"OBJECTIVE To assess the feasibility and efficacy of a yoga treatment for menopausal symptoms . Both physiologic and self-reported measures of hot flashes were included . METHODS A prospect i ve within-group pilot study was conducted . Participants were 12 peri- and post-menopausal women experiencing at least 4 menopausal hot flashes per day , at least 4 days per week . Assessment s were administered before and after completion of a 10-week yoga program . Pre- and post-treatment measures included : Severity of question naire-rated menopausal symptoms ( Wiklund Symptom Check List ) , frequency , duration , and severity of hot flashes ( 24-h ambulatory skin-conductance monitoring ; hot-flash diary ) , interference of hot flashes with daily life ( Hot Flash Related Daily Interference Scale ) , and subjective sleep quality ( Pittsburgh Sleep Quality Index ) . Yoga classes included breathing techniques , postures , and relaxation poses design ed specifically for menopausal symptoms . Participants were asked to practice at home 15 min each day in addition to weekly classes . RESULTS Eleven women completed the study and attended a mean of 7.45 ( S.D. 1.63 ) classes . Significant pre- to post-treatment improvements were found for severity of question naire-rated total menopausal symptoms , hot-flash daily interference ; and sleep efficiency , disturbances , and quality . Neither 24-h monitoring nor accompanying diaries yielded significant changes in hot flashes . CONCLUSIONS The yoga treatment and study procedures were feasible for midlife women . Improvement in symptom perceptions and well being warrant further study of yoga for menopausal symptoms , with a larger number of women and including a control group",
"Objective : To study the effect of yoga on the climacteric symptoms , perceived stress , and personality in perimenopausal women . Design : One hundred twenty participants ( ages 40 - 55 y ) were r and omly divided into two study arms , ie , yoga and control . The yoga group practice d an integrated approach to yoga therapy comprising surya namaskara ( sun salutation ) with 12 postures , pranayama ( breathing practice s ) , and avartan dhyan ( cyclic meditation ) , whereas the control group practice d a set of simple physical exercises under supervision of trained teachers for 8 weeks ( 1 h daily , 5 days per week ) . The assessment s were made by Greene Climacteric Scale , Perceived Stress Scale , and Eysenck 's Personality Inventory before and after the intervention . Results : Of the three factors of the Greene Climacteric Scale , the Mann-Whitney test showed a significant difference between groups ( P vasomotor symptoms , a marginally significant difference ( P = 0.06 ) in psychological factors but not in the somatic component . Effect sizes were higher in the yoga group for all factors . There was a significantly greater degree of decrease in Perceived Stress Scale scores ( P Eysenck 's Personality Inventory , the decrease in neuroticism was greater ( P extroversion in either the yoga or control group . Conclusions : Eight weeks of an integrated approach to yoga therapy decreases climacteric symptoms , perceived stress , and neuroticism in perimenopausal women better than physical exercise",
" Twenty hypertensive patients treated by psychophysical relaxation exercises were followed up monthly for 12 months . Age and sex matched hypertensive controls were similarly followed up for 9 months . Statistically significant reductions in blood-pressure ( BP ) and antihypertensive drug requirements were satisfactorily maintained in the treatment group . Mere repetition of B.P. measurements and increased medical attention did not in themselves reduce B.P. significantly in control patients",
"Systolic time intervals ( STI ) are non-invasive and sensitive tests for measuring the ventricular performance . It has been reported that practice of pranayam modulates cardiac autonomic status and improves cardio-respiratory functions . Keeping this in view , the present study was design ed to determine whether pranayam training has any effect on ventricular performance as measured by STI and cardiac autonomic function tests ( AFT ) . Twenty four school children were r and omly divided into two groups of twelve each . Group I ( pranayam group ) subjects were given training in nadishuddhi , mukh-bhastrika , pranav and savitri pranayams and practice d the same for 20 minutes daily for a duration of 3 months . Group II ( control group ) subjects were not given any pranayam training . STI ( QS2 , LVET and PEP ) and AFT ( RRIV and QT/QS2 ) were measured in both the groups at the beginning and again at the end of three months study period . Pranayam training produced an increase in RRIV and a decrease in QT/QS2 , suggesting an enhanced parasympathetic and blunted sympathetic activity respectively . QS2 , PEP and PEP/LVET increased significantly , whereas LVET was reduced significantly in pranayam group . In contrast , the changes in STI and AFT were much less marked in the control group . Our study shows that three months of pranayam training modulates ventricular performance by increasing parasympathetic activity and decreasing sympathetic activity . Further studies on a larger sample size may illustrate the underlying mechanism(s ) involved in this alteration",
"& NA ; The issue of what constitutes an effective and realistic acupuncture placebo control has been a continuing problem for acupuncture research . In order to provide an effective placebo , the control procedure must be convincing , visible and should mimic , in all respects , apart from a physiological effect , the real active treatment . The ‘ Streitberger ’ needle might fulfil these criteria and this paper reports on a validation study . This was a single‐blind , r and omised , cross‐over pilot study . Patients were drawn from the orthopaedic hip and knee , joint replacement waiting list . Intervention consisted of either 2 weeks of treatment with real acupuncture followed by 2 weeks on placebo , or vice versa . The prime outcome was a needle sensation question naire and there was a range of secondary outcomes . Thirty‐seven patients were r and omised and completed treatment . Groups were well balanced at baseline . No significant differences between groups or needle types were found for any of the sensations measured . Most patients were unable to discriminate between the needles by penetration ; however , nearly 40 % were able to detect a difference in treatment type between needles . No major differences in outcome between real and placebo needling could be found . The fact that nearly 40 % of subjects did not find that the two interventions were similar , however , raises some concerns with regard to the wholesale adoption of this instrument as a st and ard acupuncture placebo . Further work on inter‐tester reliability and st and ardisation of technique is highly recommended before we can be confident about using this needle in further studies",
"OBJECTIVE To determine the effects of clonidine , which reduces central sympathetic activation , on the sweating threshold in postmenopausal women with and without hot flashes . DESIGN Laboratory physiologic study . SETTING University medical center . PATIENT(S ) 12 healthy postmenopausal women reporting frequent hot flashes and 7 reporting none . INTERVENTION(S ) In two separate sessions , participants received a blind intravenous injection of clonidine HCl ( 2 microg/kg of body weight ) or placebo , followed by body heating . MAIN OUTCOME MEASURE(S ) Core body temperature , mean skin temperature , sweat rate , sternal skin conductance level , and blood pressure . RESULT ( S ) Symptomatic women had significantly lower core body temperature sweating thresholds than asymptomatic women after receiving placebo . Clonidine significantly increased this threshold in symptomatic women but lowered it in asymptomatic women . CONCLUSION ( S ) These results support the hypothesis that elevated brain norepinephrine levels reduce the sweating threshold in symptomatic women , thereby contributing to the initiation of menopausal hot flashes",
"Objective : To examine the validity of using sternal skin conductance monitoring as a measure of hot flash intensity and hot flash distress . Design : Descriptive , prospect i ve , longitudinal data from the 2-week baseline of a larger hot flash intervention study ; 73 breast cancer survivors with daily hot flashes wore a hot flash monitor and completed a hot flash diary during two 24-hour assessment periods that were separated in time by 1 week . Results : Data consisted of 569 diary rated hot flashes ; 46.9 % had magnitude of less than 2.0 micromhos ( insufficient to meet objective hot flash criterion ) and 26.3 % had magnitude of 0.0 micromho ( no change in skin conductance ) . Results from mixed-linear modeling indicated that , although magnitude significantly predicted hot flash intensity and distress , effect sizes were very small : less than 2 % when using all observations , and less than 1 % when using only the subset meeting objective hot flash criteria . Even after adjusting for covariates that were associated with intensity or distress , magnitude explained very little variance in intensity or distress ( sternal skin conductance , an indicator of sweat gl and activity , should not be used as a proxy measure of subjective hot flash intensity or distress . Future research should continue to subjectively measure hot flash intensity and distress when these are important outcome variables to consider"
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OBJECTIVE To identify whether nutrient supplementation with probiotics , prebiotics , formula , or fatty acids prevents the development of atopic dermatitis ( AD ) or reduces the severity of AD in newborns to children younger than 3 years . DATA SOURCES We search ed MEDLINE , Cochrane Central Register of Controlled Trials , and LILACS ( Latin American and Caribbean Health Science Literature ) from January 1 , 1946 , to August 27 , 2012 , and performed an additional manual search . STUDY SELECTION R and omized controlled trials and cohort studies examining nutritional supplementation in prevention and amelioration of AD among children younger than 3 years . DATA EXTRACTION Of 92 articles , 21 met inclusion criteria . DATA SYNTHESIS In the 21 studies , a total of 6859 participants received supplements , which included infants or mothers who were either pregnant or breastfeeding;4134 infants or mothers served as controls . Nutritional supplementation was shown to be an effective method in preventing AD ( 11 of 17 studies ) or decreasing its severity(5 of 6 studies ) . The best evidence lies with probiotics supplementation in mothers and infants in preventing development and reducing severity of AD . Specifically , Lactobacillus rhamnosus GG was effective in long-term prevention of AD development . γ-Linolenic acid reduced severity of AD . Supplementation with prebiotics and black currant seed oil ( γ-linolenic acid and ω-3 combination ) was effective in reducing the development of AD . Conflicting findings were reported from different research groups that performed supplementation with an amino acid – based formula . CONCLUSIONS Certain types of nutrient supplementation are beneficial in preventing AD development and reducing its severity . Future research elucidating the mechanisms underlying the actions of nutritional supplementation on AD is necessary
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"Polyunsaturated fatty acids ( PUFAs ) are components of cell membranes and may play an immunomodulating role in the pathogenesis of atopic dermatitis ( AD ) . The goal was to determine the impact of PUFAs on AD by dietary supplementation of infants . Based on the parents ' decision on their babies ' primary feeding , mothers and newborns were r and omized to the supplementation with gamma-linolenic acid ( GLA ) or placebo for up to 6 months . Breastfed infants received GLA by supplementing their mothers . Formula diet was commercial whey hydrolysate unsupplemented with PUFAs . Of 131 eligible infants , 24 developed AD within the first year of life . Of these , nine belonged to the exclusively breastfed group ( n = 58 ) , 14 to the combined-fed group ( n = 53 ) , and one to the never breastfed group ( n = 20 ) . We could not find an influence of GLA on the development of AD . In subjects with AD , at 1 yr of age the serum-immunoglobulin E ( IgE ) was the lowest in the GLA-supplemented group A-subjects . In the GLA-supplemented group , GLA-levels in breast milk were similar in atopic and non-atopic infants . In the non-supplemented group the GLA-content of breast milk was 0.07 % of total fatty acids in atopic infants vs. 0.17 % in non-atopic infants ( p GLA-supplementation could not prevent AD . Interestingly , the number of infants developing AD was the lowest in never breastfed children . In infants suffering from AD , GLA-supplementation seemed to reduce total IgE in the first year of life",
"Perinatal administration of the probiotic Lactobacillus rhamnosus strain GG ( ATCC 53103 ) , reduces incidence of atopic eczema in at-risk children during the first 2 years of life ( infancy ) . We have therefore assessed persistence of the potential to prevent atopic eczema at 4 years . Atopic disease was diagnosed on the basis of a question naire and a clinical examination . 14 of 53 children receiving lactobacillus had developed atopic eczema , compared with 25 of 54 receiving placebo ( relative risk 0.57 , 95 % CI 0.33 - 0.97 ) . Skin prick test reactivity was the same in both groups : ten of 50 children previously given lactobacillus compared with nine of 50 given placebo tested positive . Our results suggest that the preventive effect of lactobacillus GG on atopic eczema extends beyond infancy",
"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 Studies suggest that low concentrations of n-6 long-chain polyenes in early life are correlated to atopic disease in later life . OBJECTIVE The purpose of the study was to investigate the possible preventive effect of gamma-linolenic acid ( GLA ) supplementation on the development of atopic dermatitis in infants at risk . DESIGN In a double-blind , r and omized , placebo-controlled trial , formula-fed infants ( n = 118 ) with a maternal history of atopic disease received borage oil supplement ( containing 100 mg GLA ) or sunflower oil supplement as a placebo daily for the first 6 mo of life . Main outcome measures were the incidence of atopic dermatitis in the first year of life ( by UK Working Party criteria ) , the severity of atopic dermatitis ( SCORing Atopic Dermatitis ; SCORAD ) , and the total serum immunoglobulin E ( IgE ) concentration at the age of 1 y. RESULTS The intention-to-treat analysis showed a favorable trend for severity of atopic dermatitis associated with GLA supplementation ( x+/- SD SCORAD : 6.32 + /- 5.32 ) in the GLA-supplemented group as compared with 8.28 + /- 6.54 in the placebo group ( P = 0.09 ; P = 0.06 after adjustment for total serum IgE at baseline , age 1 wk ) , but no significant effects on the other atopic outcomes . The increase in GLA concentrations in plasma phospholipids between baseline and 3 mo was negatively associated with the severity of atopic dermatitis at 1 y ( Spearman 's correlation coefficient = -0.233 , P = 0.013 ) . There was no significant effect on total serum IgE concentration . CONCLUSION Early supplementation with GLA in children at high familial risk does not prevent the expression of atopy as reflected by total serum IgE , but it tends to alleviate the severity of atopic dermatitis in later infancy in these children",
"Cloth diapers , cellulose core diapers ( conventional disposable diapers ) , and cellulose core diapers containing absorbent gelling material were examined for their effects on diaper rash and skin microbiology of normal infants and infants with atopic dermatitis in a 26-week double-blind clinical trial . Infants with atopic dermatitis wearing the diapers containing absorbent gelling material had significantly lower diaper rash grade s than infants with atopic dermatitis wearing cloth diapers at five of eight grading visits . Infants with atopic dermatitis wearing conventional cellulose core diapers had statistically less rash at one of eight visits . There was no statistically significant difference between diaper types at three of the eight visits . At no time did the cloth group have less diaper rash than the conventional cellulose or absorbent gelling material disposable diaper group . A statistical correlation between the severity of general atopic dermatitis outside the diaper area and the diaper rash condition under the diaper occurred only in the atopic dermatitis group wearing cloth diapers . Isolation of microorganisms from the intact , uninvolved skin surface both inside and outside the diaper showed no biologically significant changes in the presence or numbers of selected skin organisms . Repeated isolation , at multiple grading visits of Staphylococcus aureus from uncompromised skin inside the diaper area was infrequent but correlated with the diagnosis of atopic dermatitis when observed",
"BACKGROUND Recommendations for primary prevention of allergic diseases in high-risk children include feeding with hydrolyzed formulas if breast-feeding is insufficient . OBJECTIVE The primary objective of the German Infant Nutritional Intervention study was to investigate the allergy preventive effect of 3 hydrolyzed formulas compared with cow 's milk formula in the first 3 years of life in a r and omized , double-blind trial . METHODS Between 1995 and 1998 , 2252 newborns with atopic heredity were allocated to a group receiving cow 's milk formula , partially or extensively hydrolyzed whey formula , or extensively hydrolyzed casein formula as a milk substitute for the first 4 months if breast-feeding was insufficient . Main outcome parameters were allergic manifestations , atopic dermatitis ( AD ) , and asthma . RESULTS After 3 years , 396 of 2252 children ( 17.6 % ) had dropped out . Breast-fed infants without formula feeding during the intervention ( n = 889 ) were considered separately . A significant reduction of the incidence of AD was achieved with the extensively hydrolyzed casein formula in the intention-to-treat ( ITT ; n = 1363 ) and per protocol ( PP ; n = 904 ) analyses ( ITT : population odds ratio [ 95 % CI ] , 0.67 [ 0.45 - 0.99 ] ; PP : adjusted odds ratio [ OR(adj ) ] , 0.53 [ 0.32 - 0.88 ] ) , and with the partially hydrolyzed whey formula in the PP analysis ( ITT : population odds ratio , 0.76 [ 0.52 - 1.11 ] ; PP : OR(adj ) , 0.60 [ 0.37 - 0.97 ] ) . None of the formulas reduced the incidence of asthma . CONCLUSION The risk for AD , but not for asthma , can be reduced with certain cow 's milk hydrolyzates in high-risk infants when breast-feeding is insufficient . CLINICAL IMPLICATION S Early nutritional intervention in high-risk children has significant influence on the incidence of AD , but not of asthma",
"This prospect i ve , long-term study assessed the effects of a protein hydrolysate formula on allergy prevention in infants with a family history of allergy . Infants were r and omly assigned to receive either the hydrolysate formula ( n = 92 ) or an adapted cow milk formula ( n = 85 ) alone or with breast-feeding for 4 months . The groups did not differ in family allergy history scores or cord blood IgE levels . After 4 months , total IgE levels and allergic reactions did not differ significantly between groups , although the hydrolysate group had a lower prevalence of eczema . At 12 months of age , neither IgE levels nor allergic reactions were significantly different . At 2 years of age , however , 18 allergic reactions had occurred in the hydrolysate group and 31 had occurred in the control group ; the differences were significant for eczema ( p asthma . At 4 years of age , allergic signs were found in 11 children in the hydrolysate group and in 17 children in the control group ; the difference was significant only for eczema ( p protein hydrolysate formula to infants at risk for allergies had a long-term preventive effect on the prevalence of eczema but not of asthma",
"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",
"Controversy exists regarding the preventive effect of probiotics on the development of eczema or atopic dermatitis . We investigated whether supplementation of probiotics prevents the development of eczema in infants at high risk . In a r and omized , double-blind , placebo-controlled trial , 112 pregnant women with a family history of allergic diseases received a once-daily supplement , either a mixture of Bifidobacterium bifidum BGN4 , B. lactis AD011 , and Lactobacillus acidophilus AD031 , or placebo , starting at 4 - 8 wks before delivery and continuing until 6 months after delivery . Infants were exclusively breast-fed during the first 3 months , and were subsequently fed with breastmilk or cow 's milk formula from 4 to 6 months of age . Clinical symptoms of the infants were monitored until 1 yr of age , when the total and specific IgE against common food allergens were measured . A total of 68 infants completed the study . The prevalence of eczema at 1 yr in the probiotic group was significantly lower than in the placebo group ( 18.2 % vs. 40.0 % , p=0.048 ) . The cumulative incidence of eczema during the first 12 months was reduced significantly in probiotic group ( 36.4 % vs. 62.9 % , p=0.029 ) ; however , there was no difference in serum total IgE level or the sensitization against food allergens between the two groups . Prenatal and postnatal supplementation with a mixture of B. bifidum BGN4 , B. lactis AD011 , and L. acidophilus AD031 is an effective approach in preventing the development of eczema in infants at high risk of allergy during the first year of life",
"Over the last two decades the incidence of allergic diseases has increased in industrialized countries , and consequently new approaches have to be explored",
"Cow 's milk and soy protein allergies are commonly associated with atopic dermatitis ( AD ) in young children . Amino acid (AA)-based elemental milk formula may improve AD control in these patients . This study investigates the efficacy of AA-based formula in treating young AD patients irrespective of their food allergy status . AD patients younger than 3 yr old were eligible . Sensitization to food allergens was ascertained by skin prick tests and allergen-specific immunoglobulin E ( IgE ) assay . Patients were then r and omly allocated to take either active treatment or pre-existing formulae ( placebo ) for 6 wk . They were allowed a 6-wk washout period before crossed over to the other intervention for another 6 wk . Fifteen AD patients , with median ( interquartile range , IQR ) age of 1.4 ( 0.6 - 2.6 ) yr , were recruited . Their median ( IQR ) SCORAD score was 23.9 ( 10.5 - 29.7 ) . Seven of them were sensitized to cow 's milk or soybean . Among 11 patients who completed the study , the median changes for all scores and urinary eosinophil protein X ( EPX ) concentration were not statistically significant . There was also no evidence of carry-over effects for SCORAD and its various components and global health score , except for urinary EPX concentration ( p = 0.05 ) . Our results do not support the use of AA-based elemental milk formula in treating young children with AD irrespective of their food allergy status",
"Objective To determine whether dietary n-3 long chain polyunsaturated fatty acid ( LCPUFA ) supplementation of pregnant women with a fetus at high risk of allergic disease reduces immunoglobulin E associated eczema or food allergy at 1 year of age . Design Follow-up of infants at high hereditary risk of allergic disease in the Docosahexaenoic Acid to Optimise Mother Infant Outcome ( DOMInO ) r and omised controlled trial . Setting Adelaide , South Australia . Participants 706 infants at high hereditary risk of developing allergic disease whose mothers were participating in the DOMInO trial . Interventions The intervention group ( n=368 ) was r and omly allocated to receive fish oil capsules ( providing 900 mg of n-3 LCPUFA daily ) from 21 weeks ’ gestation until birth ; the control group ( n=338 ) received matched vegetable oil capsules without n-3 LCPUFA . Main outcome measure Immunoglobulin E associated allergic disease ( eczema or food allergy with sensitisation ) at 1 year of age . Results No differences were seen in the overall percentage of infants with immunoglobulin E associated allergic disease between the n-3 LCPUFA and control groups ( 32/368 ( 9 % ) v 43/338 ( 13 % ) ; unadjusted relative risk 0.68 , 95 % confidence interval 0.43 to 1.05 , P=0.08 ; adjusted relative risk 0.70 , 0.45 to 1.09 , P=0.12 ) , although the percentage of infants diagnosed as having atopic eczema ( that is , eczema with associated sensitisation ) was lower in the n-3 LCPUFA group ( 26/368 ( 7 % ) v 39/338 ( 12 % ) ; unadjusted relative risk 0.61 , 0.38 to 0.98 , P=0.04 ; adjusted relative risk 0.64 , 0.40 to 1.02 , P=0.06 ) . Fewer infants were sensitised to egg in the n-3 LCPUFA group ( 34/368 ( 9 % ) v 52/338 ( 15 % ) ; unadjusted relative risk 0.61 , 0.40 to 0.91 , P=0.02 ; adjusted relative risk 0.62 , 0.41 to 0.93 , P=0.02 ) , but no difference between groups in immunoglobulin E associated food allergy was seen . Conclusion n-3 LCPUFA supplementation in pregnancy did not reduce the overall incidence of immunoglobulin E associated allergies in the first year of life , although atopic eczema and egg sensitisation were lower . Longer term follow-up is needed to determine if supplementation has an effect on respiratory allergic diseases and aeroallergen sensitisation in childhood . Trial registration Australian New Zeal and Clinical Trials Registry ACTRN12610000735055 ( DOMInO trial : ACTRN12605000569606 )",
"Abstract Background : The role of probiotics in the treatment of atopic dermatitis ( AD ) remains controversial . A recent systematic review of the available evidence called for further clinical trials with new probiotic formulations . Objective : To assess the clinical efficacy and impact of Lactobacillus acidophilus DDS-1 , Bifidobacterium lactis UABLA-12 with fructo-oligosaccharide on peripheral blood lymphocyte subsets in preschool children with moderate-to-severe AD . Method : R and omized , double-blind , placebo-controlled , prospect i ve trial of 90 children aged 1–3 years with moderate-to-severe AD who were treated with a mixture of L. acidophilus DDS-1 , B. lactis UABLA-12 with fructo-oligosaccharide at a dosage of 5 billion colony-forming units twice daily for 8 weeks versus placebo . The primary outcome measure was the percentage change in Scoring of Atopic Dermatitis ( SCORAD ) value . Other outcome measures were changes in Infant Dermatitis Quality Of Life ( IDQOL ) and Dermatitis Family Impact ( DFI ) scores , frequency and amount of topical corticosteroid used , and lymphocyte subsets in peripheral blood measured by laser flow cytometry . Results : At the final visit , the percentage decrease in SCORAD was 33.7 % in the probiotic group compared with 19.4 % in the placebo group ( p = 0.001 ) . Children receiving probiotic showed a greater decrease in the mean [ SD ] SCORAD score than did children from the placebo group at week 8 ( −14.2 [ 9.9 ] vs −7.8 [ 7.7 ] , respectively ; p = 0.001 ) . IDQOL and DFI scores decreased significantly from baseline by 33.0 % and 35.2 % in the probiotic group and by 19.0 % and 23.8 % in the placebo group , respectively ( p = 0.013 , p = 0.010 ) . Use of topical corticosteroids during the 8-week trial period averaged 7.7 g less in probiotic patients ( p = 0.006 ) . CD3 , CD16 , and CD22 lymphocyte subsets remained unchanged , whereas the percentage of CD4 , and the percentage and absolute count of CD25 decreased , and the percentage and absolute count of CD8 increased in the probiotic group at week 8 ( p between CD4 percentage , CD25 percentage , CD25 absolute count , and SCORAD values ( r = 0.642 , r = 0.746 , r = 0.733 , respectively ; p probiotic mixture containing L. acidophilus DDS-1 , B. lactis UABLA- 12 , and fructo-oligosaccharide was associated with significant clinical improvement in children with AD , with corresponding lymphocyte subset changes in peripheral blood . The efficacy of probiotic therapy in adults with AD requires further investigation",
"BACKGROUND The potential of extensively or partially hydrolyzed formulas to reduce the risks for allergies is controversial . OBJECTIVE We sought to assess the preventive effect of differently hydrolyzed formulas compared with cow 's milk formula ( CMF ) in high-risk infants . METHODS Between 1995 and 1998 , 2252 infants with a hereditary risk for atopy were enrolled in the German Infant Nutritional Intervention Study and r and omly assigned at birth to one of 4 blinded formulas : CMF , partially hydrolyzed whey formula , extensively hydrolyzed whey formula , and extensively hydrolyzed casein formula ( eHF-C ) . The primary end point at 1 year of age was the presence of allergic manifestation , which was defined as atopic dermatitis ( AD ) , gastrointestinal manifestation of food allergy , allergic urticaria , or a combination of these factors . RESULTS At 12 months per protocol , analysis was performed on 945 infants exposed to study formula : 304 ( 13.5 % ) infants had left the study , 138 ( 6.1 % ) infants were excluded because of noncompliance , and 865 infants were exclusively breast-fed the first 4 months of life . The incidence of allergic manifestation was significantly reduced by using eHF-C compared with CMF ( 9 % vs 16 % ; adjusted OR , 0.51 ; 95 % CI , 0.28 - 0.92 ) , and the incidence of AD was significantly reduced by using eHF-C ( OR , 0.42 ; 95 % CI , 0.22 - 0.79 ) and partially hydrolyzed whey formula ( OR , 0.56 ; 95 % CI , 0.32 - 0.99 ) . Family history of AD was a significant risk factor and modified the preventive effect of the hydrolysates . CONCLUSIONS Prevention of allergic diseases in the first year of life is feasible by means of dietary intervention but influenced by family history of AD . The preventive effect of each hydrolyzed formula needs to be clinical ly evaluated",
"BACKGROUND The role of probiotics in prevention of allergic disease is still not clearly established , although early reports suggested Lactobacillus GG halved the risk of eczema at 2 years . OBJECTIVE To determine whether probiotic supplementation in early life could prevent development of eczema and atopy at 2 years . METHODS Double-blind , r and omized placebo-controlled trial of infants at risk of allergic disease . Pregnant women were r and omized to take Lactobacillus rhamnosus HN001 ( L rhamnosus ) , Bifidobacterium animalis subsp lactis strain HN019 or placebo daily from 35 weeks gestation until 6 months if breast-feeding , and their infants were r and omized to receive the same treatment from birth to 2 years ( n = 474 ) . The infant 's cumulative prevalence of eczema and point prevalence of atopy , using skin prick tests to common allergens , was assessed at 2 years . RESULTS Infants receiving L rhamnosus had a significantly ( P = .01 ) reduced risk of eczema ( hazard ratio [ HR ] , 0.51 ; 95 % CI , 0.30 - 0.85 ) compared with placebo , but this was not the case for B animalis subsp lactis ( HR , 0.90 ; 95 % CI , 0.58 - 1.41 ) . There was no significant effect of L rhamnosus ( HR , 0.74 ; 95 % CI , 0.46 - 1.18 ) or B animalis subsp lactis ( HR , 0.82 ; 95 % CI , 0.52 - 1.28 ) on atopy . L rhamnosus ( 71.5 % ) was more likely than B animalis subsp lactis ( 22.6 % ) to be present in the feces at 3 months , although detection rates were similar by 24 months . CONCLUSION We found that supplementation with L rhamnosus , but not B animalis subsp lactis , substantially reduced the cumulative prevalence of eczema , but not atopy , by 2 years . Underst and ing how Lactobacilli act to prevent eczema requires further investigation",
"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",
"Cow 's milk allergy/intolerance is treated by complete avoidance of cow 's milk proteins . Because cow 's milk is an important food for infants , its avoidance may lead to an increased risk of growth impairment . Whilst there is evidence for the beneficial effects of extensively hydrolyzed cow 's milk formulate ( eHF ) in infants with cow 's milk allergy/intolerance , little is known about the effects of amino-acid-based formulae ( AA ) in such infants . We therefore performed a prospect i ve , controlled , multi-center trial to study the efficacy of AA in comparison with eHF , on the growth and clinical symptoms of 73 infants ( median age 5.7 months ) with cow 's milk allergy/intolerance and atopic dermatitis . Cow 's milk allergy/intolerance was proven in all infants by double-blind , placebo-controlled food-challenge . We observed a significant improvement in the SCORAD index in both groups , from a mean of 24.6 , at entry , to a mean of 10.7 ( p length st and ard deviation score ( p weight-for-length values were stable in both groups . The energy intake during the study was similar in both groups . Both an AA and eHF result ed in a significant clinical improvement in infants with an early onset of symptoms of cow 's milk allergy/intolerance . Feeding an AA result ed in improved growth compared with feeding eHF , despite similar dietary intakes , and may therefore be considered as a beneficial alternative in infants with severe cow 's milk allergy intolerance",
"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"
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Background : Absolute stroke rates vary widely among patients with nonvalvular atrial fibrillation . To balance the benefits and risks of chronic antithrombotic prophylaxis , it is important to estimate the absolute risk of stroke for individual patients . Methods : Systematic review of studies using multivariate regression techniques to identify independent risk factors for stroke in patients with atrial fibrillation was conducted , and reports of absolute stroke rates in subgroups of patients with these risk factors collected . A summary estimate of the relative risk associated with each independent risk factor was calculated using maximum likelihood methods . Results : Seven studies ( including six entirely independent cohorts ) were identified . Prior stroke/TIA ( relative risk 2.5 , 95 % CI 1.8 to 3.5 ) , increasing age ( relative risk 1.5 per decade , 95 % CI 1.3 to 1.7 ) , a history of hypertension ( relative risk 2.0 , 95 % CI 1.6 to 2.5 ) , and diabetes mellitus ( relative risk 1.7 , 95 % CI 1.4 to 2.0 ) were the strongest , most consistent independent risk factors . Observed absolute stroke rates for nonanticoagulated patients with single independent risk factors were in the range of 6 to 9 % per year for prior stroke/TIA , 1.5 to 3 % per year for history of hypertension , 1.5 to 3 % per year for age > 75 , and 2.0 to 3.5 % per year for diabetes . Female sex was inconsistently associated with stroke risk , whereas the evidence was inconclusive that either heart failure or coronary artery disease is independently predictive of stroke . Conclusions : Four clinical features ( prior stroke/TIA , advancing age , hypertension , diabetes ) are consistent independent risk factors for stroke in atrial fibrillation patients . Prior stroke/TIA is the most powerful risk factor and reliably confers a high stroke risk ( > 5 % per year , averaging 10 % per year ) . Absolute stroke rates associated with other individual risk factors are difficult to precisely estimate from available data
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"Stroke associated with atrial fibrillation ( AF ) is mainly due to embolism of thrombus formed during stasis of blood in the left atrial appendage ( LAA ) . Pathophysiologic correlates of appendage flow velocity as assessed by transesophageal echocardiography ( TEE ) in patients with AF have not been defined . To evaluate the hypothesis that reduced velocity is associated with spontaneous echocardiographic contrast and thrombus in the LAA and with clinical embolic events , we measured LAA flow velocity by TEE in 721 patients with nonvalvular AF entering the Stroke Prevention in Atrial Fibrillation ( SPAF-III ) study . Patient features , TEE findings , and subsequent cardioembolic events were correlated with velocity by multivariate analysis . Patients in AF during TEE displayed lower peak ante grade ( emptying ) flow velocity ( Anu(p ) ) than those with intermittent AF in sinus rhythm during TEE ( 33 cm/s vs 61 cm/s , respectively , P dense spontaneous echocardiographic contrast ( P appendage thrombus ( P subsequent cardioembolic events ( P systolic blood pressure ( P sustained AF ( P = .01 ) , ischemic heart disease ( P = .01 ) , and left atrial area ( P = .04 ) . Multivariate analysis found both Anu(p ) . LAA Anu(p ) is reduced in AF and associated with spontaneous echocardiographic contrast , appendage thrombus , and cardioembolic stroke . Systolic hypertension and aortic atherosclerosis , independent clinical predictors of stroke in patients with AF , also correlated with LAA Anu(p ) . Our results support the role of reduced LAA Anu(p ) in the generation of stasis , thrombus formation , and embolism in patients with AF , although other mechanisms also contribute to stroke",
"Stroke incidence in Copenhagen , Denmark was recorded in a r and om population sample of 19,327 persons invited for two health examinations with 5 years ' interval from 1976 to 1983 . Stroke incidence increased exponentially with age . After adjustment to the age and sex distribution of the Danish population in 1980 , the estimated incidence of first stroke was 1.41/1000 women and 2.48/1000 men ; the total incidence was 1.94/1000 population . Risk factor analysis was based on the initial examination of 13,088 persons greater than 35 years old without previous stroke who responded to the first invitation , in whom 295 first strokes were subsequently observed . We used the regression model of Cox . However , our use of this model differs from the somewhat automatic procedures normally used to develop prognostic models . Evaluation of the causative effect of a particular risk factor requires that the direction of mutual influences between the factor in question and other risk factors is established/postulated . Among the 16 potential risk factors for stroke we examined , significant effects were found for age , sex , household income , smoking habits , systolic blood pressure , diabetes , plasma cholesterol concentration , ischemic heart disease , and atrial fibrillation . No significant effect could be demonstrated for a positive family history of stroke , years of school education , marital status , alcohol consumption , daily use of tranquilizers , body mass index , or postmenopausal hormone treatment",
"BACKGROUND AND PURPOSE Nonvalvular atrial fibrillation ( AF ) is a strong , independent risk factor for stroke , but the absolute rate of stroke varies widely among AF patients , importantly influencing the potential benefit of antithrombotic prophylaxis . We explore factors associated with ischemic stroke in AF patients taking aspirin . METHODS We performed multivariate logistic regression analysis of 2012 participants given aspirin alone or in combination with low , inefficacious doses of warfarin in the Stroke Prevention in Atrial Fibrillation I-III trials followed for a mean of 2.0 years , during which 130 ischemic strokes were observed . RESULTS Age ( relative risk [RR]=1.8 per decade , P hypertension ( RR=2.0 , P systolic blood pressure > 160 mm Hg ( RR=2.3 , P prior stroke or transient ischemic attack ( RR=2.9 , P stroke risk . Regular consumption of > /=14 alcohol-containing drinks per week was associated with reduced stroke risk ( adjusted RR=0.4 , P=0.04 ) . Among SPAF III participants , estrogen hormone replacement therapy was associated with a higher risk of ischemic stroke ( adjusted RR=3.2 , P=0.007 ) . With the use of these variables , a risk stratification scheme for primary prevention separated participants into those with high ( 7.1%/y , 22 % of the cohort ) , moderate ( 2.6%/y , 37 % of the cohort ) , and low ( 0.9%/y , 41 % of the cohort ) rates of stroke . Ischemic strokes in low-risk participants were less often disabling ( P Patients with AF who have high and low rates of stroke during treatment with aspirin can be identified . However , validation of our risk stratification scheme is necessary before it can be applied with confidence to clinical management . Postmenopausal estrogen replacement therapy and moderate alcohol consumption may additionally modify the risk of stroke in AF , but these findings require confirmation",
"Background and Purpose — Long-term anticoagulation is routinely used for secondary stroke prevention in atrial fibrillation , often regardless of stroke subtype . Although the role of warfarin in cardioembolic stroke is established , it may not prevent recurrence in other stroke subtypes , even in the presence of atrial fibrillation . Methods — This was a 2-year , prospect i ve , intervention study conducted in a district general hospital . Participants included 386 acute stroke patients with atrial fibrillation . Subjects were characterized for stroke subtype on clinical , neuroimaging , carotid ultrasonographic , and echocardiographic criteria . Eligible patients were treated with adjusted-dose warfarin ( international normalized ratio , 2.0 to 3.0 ) . Aspirin ( 75 to 300 mg/d ) was used in patients with contraindications or those who refused anticoagulation . The main outcome measures were rate of recurrent stroke by subtype and major and minor bleeding complications . Results — The aspirin group ( n=172 ) was comparable to the warfarin group ( n=214 ) in terms of age , sex , risk factors , and initial stroke subtype . The rate of recurrent stroke was higher ( 9.5 % versus 4.9 % , P major bleeding was lower ( 0.6 % versus 2.5 % , P increased stroke rate with aspirin was due predominantly to cardioembolic recurrence in patients presenting initially with cardioembolic stroke ( 8.4 % versus 1.9 % , P recurrence rate in aspirin-treated patients who presented with lacunar stroke and atrial fibrillation was similar to that seen in patients receiving warfarin ( 8.8 % versus 8.9 % ) . Conclusions — In this cohort of stroke patients with atrial fibrillation , anticoagulation was superior to aspirin in preventing cardioembolic but not lacunar recurrence . Determination of stroke subtype may be important in anticoagulation decisions for secondary prevention , and further studies are required",
"Background Atrial fibrillation in the absence of rheumatic valvular disease is associated with a fivefold to sevenfold increased risk of ischemic stroke . Methods and Main Results . The Stroke Prevention in Atrial Fibrillation Study , a multicenter , r and omized trial , compared 325 mg/day aspirin ( double-blind ) or warfarin with placebo for prevention of ischemic stroke and systemic embolism ( primary events ) , and included 1,330 in patients and out patients with constant or intermittent atrial fibrillation . During a mean follow-up of 1.3 years , the rate of primary events in patients assigned to placebo was 6.3 % per year and was reduced by 42 % in those assigned to aspirin ( 3.6 % per year , p = 0.02 ; 95 % confidence interval , 9–63 % ) . In the subgroup of warfarin-eligible patients ( most less than 76 years old ) , warfarin dose-adjusted to prolong prothrombin time to 1.3-fold to 1.8-fold that of control reduced the risk of primary events by 67 % ( warfarin versus placebo , 2.3 % versus 7.4 % per year , p = 0.01 ; 95 % confidence interval , 27–85 % ) . Primary events or death were reduced 58 % ( p = 0.01 ) by warfarin and 32 % ( p = 0.02 ) by aspirin . The risk of significant bleeding was 1.5 % , 1.4 % , and 1.6%o per year in patients assigned to warfarin , aspirin , and placebo , respectively . Conclusions Aspirin and warfarin are both effective in reducing ischemic stroke and systemic embolism in patients with atrial fibrillation . Because warfarin-eligible patients composed a subset of all aspirin-eligible patients , the magnitude of reduction in events by warfarin versus aspirin can not be compared . Too few events occurred in warfarin-eligible patients to directly assess the relative benefit of aspirin compared with warfarin , and the trial is continuing to address this issue . Patients with nonrheumatic atrial fibrillation who can safely take either aspirin or warfarin should receive prophylactic antithrombotic therapy to reduce the risk of stroke",
"BACKGROUND Atherosclerotic intracranial arterial stenosis is an important cause of stroke . Warfarin is commonly used in preference to aspirin for this disorder , but these therapies have not been compared in a r and omized trial . METHODS We r and omly assigned patients with transient ischemic attack or stroke caused by angiographically verified 50 to 99 percent stenosis of a major intracranial artery to receive warfarin ( target international normalized ratio , 2.0 to 3.0 ) or aspirin ( 1300 mg per day ) in a double-blind , multicenter clinical trial . The primary end point was ischemic stroke , brain hemorrhage , or death from vascular causes other than stroke . RESULTS After 569 patients had undergone r and omization , enrollment was stopped because of concerns about the safety of the patients who had been assigned to receive warfarin . During a mean follow-up period of 1.8 years , adverse events in the two groups included death ( 4.3 percent in the aspirin group vs. 9.7 percent in the warfarin group ; hazard ratio for aspirin relative to warfarin , 0.46 ; 95 percent confidence interval , 0.23 to 0.90 ; P=0.02 ) , major hemorrhage ( 3.2 percent vs. 8.3 percent , respectively ; hazard ratio , 0.39 ; 95 percent confidence interval , 0.18 to 0.84 ; P=0.01 ) , and myocardial infa rct ion or sudden death ( 2.9 percent vs. 7.3 percent , respectively ; hazard ratio , 0.40 ; 95 percent confidence interval , 0.18 to 0.91 ; P=0.02 ) . The rate of death from vascular causes was 3.2 percent in the aspirin group and 5.9 percent in the warfarin group ( P=0.16 ) ; the rate of death from nonvascular causes was 1.1 percent and 3.8 percent , respectively ( P=0.05 ) . The primary end point occurred in 22.1 percent of the patients in the aspirin group and 21.8 percent of those in the warfarin group ( hazard ratio , 1.04 ; 95 percent confidence interval , 0.73 to 1.48 ; P=0.83 ) . CONCLUSIONS Warfarin was associated with significantly higher rates of adverse events and provided no benefit over aspirin in this trial . Aspirin should be used in preference to warfarin for patients with intracranial arterial stenosis",
"BACKGROUND AND PURPOSE Despite large r and omised trials that demonstrated the efficacy of oral anticoagulants in the primary and secondary prevention of stroke in patients with non-valvular atrial fibrillation ( AF ) , anticoagulation therapy remains largely under-used in older patients , who are at risk of first ever or recurrent stroke . The aim of the present study was to assess the influence of anticoagulation therapy on long-term prognosis in the oldest old stroke patients with AF after adjusting for baseline risk factors . METHODS We evaluated prospect ively a consecutive series of 207 older people ( > 75 years ) with AF and first ever ischaemic stroke . During the follow-up period ( mean 88.4 months , range 3 - 120 ) , the study population was under either oral anticoagulants ( n = 72 ) or aspirin ( n = 135 ) . Death and recurrent vascular events ( stroke and systemic embolism ) were documented . Statistical analyses were performed by means of the Kaplan-Meier product limit method and the Cox proportional hazards model . RESULTS The cumulative 10 year mortality and recurrence rate were 92.5 % ( 95 % CI 85.7 - 99.3 ) and 66.1 % ( 95 % CI 43.1 - 89.1 ) , respectively . Cox regression analysis revealed increasing age , functional dependency at hospital discharge and antiplatelet versus anticoagulation therapy as independent determinants of mortality . Antiplatelet versus anticoagulation therapy was the sole determinant of vascular recurrence . Anticoagulation was associated with decreased risk of death ( hazards ratio ( HR ) 0.47 , 95 % CI 0.31 - 0.72 , P = 0.001 ) ) and recurrent thromboembolism ( HR 0.31 , 95 % CI 0.16 - 0.62 , P = 0.002 ) . CONCLUSIONS Our results suggest that the benefits of anticoagulation for secondary stroke prevention in AF patients extend to the oldest old . Prospect i ve r and omised clinical trials are needed to verify the potential benefit of anticoagulation in such patients",
"Background —Previous studies provide conflicting results about whether women are at higher risk than men for thromboembolism in the setting of atrial fibrillation ( AF ) . We examined data from a large contemporary cohort of AF patients to address this question . Methods and Results —We prospect ively studied 13 559 adults with AF and recorded data on patients ’ clinical characteristics and the occurrence of incident hospitalizations for ischemic stroke , peripheral embolism , and major hemorrhagic events through search ing vali date d computerized data bases and medical record review . We compared event rates by patient sex using multivariable log-linear regression , adjusting for clinical risk factors for stroke , and stratifying by warfarin use . We identified 394 ischemic stroke and peripheral embolic events during 15 494 person-years of follow-up off warfarin . After multivariable analysis , women had higher annual rates of thromboembolism off warfarin than did men ( 3.5 % versus 1.8 % ; adjusted rate ratio [ RR ] , 1.6 ; 95 % CI , 1.3 to 1.9 ) . There was no significant difference by sex in 30-day mortality after thromboembolism ( 23 % for both ) . Warfarin use was associated with significantly lower adjusted thromboembolism rates for both women and men ( RR , 0.4 ; 95 % CI , 0.3 to 0.5 ; and RR , 0.6 ; 95 % CI , 0.5 to 0.8 , respectively ) , with similar annual rates of major hemorrhage ( 1.0 % and 1.1 % , respectively ) . Conclusions —Women are at higher risk than men for AF-related thromboembolism off warfarin . Warfarin therapy appears be as effective in women , if not more so , than in men , with similar rates of major hemorrhage . Female sex is an independent risk factor for thromboembolism and should influence the decision to use anticoagulant therapy in persons with AF",
"Aspirin is only modestly effective in the secondary prevention after cerebral ischemia . Studies in other vascular disorders suggest that anticoagulant drugs in patients with cerebral ischemia of presumed arterial ( noncardiac ) origin might be more effective . The aim of the Stroke Prevention in Reversible Ischemia Trial ( SPIRIT ) therefore was to compare the efficacy and safety of 30 mg aspirin daily and oral anticoagulation ( international normalized ratio [ INR ] 3.0–4.5 ) . Patients referred to a neurologist in one of 58 collaborating centers because of a transient ischemic attack or minor ischemic stroke ( Rankin grade $ 3 ) were eligible . R and omization was concealed , treatment assignment was open , and assessment of outcome events was masked . The primary measure of outcome was the composite event “ death from all vascular causes , nonfatal stroke , nonfatal myocardial infa rct ion , or nonfatal major bleeding complication . ” The trial was stopped at the first interim analysis . A total of 1,316 patients participated ; their mean follow‐up was 14 months . There was an excess of the primary outcome event in the anticoagulated group ( 81 of 651 ) versus 36 of 665 in the aspirin group ( hazard ratio , 2.3 ; 95 % confidence interval [ CI ] , 1.6–3.5 ) . This excess could be attributed to 53 major bleeding complications ( 27 intracranial ; 17 fatal ) during anticoagulant therapy versus 6 on aspirin ( 3 intracranial ; 1 fatal ) . The bleeding incidence increased by a factor of 1.43 ( 95 % CI , 0.96–2.13 ) for each 0.5 unit increase of the achieved INR . Anticoagulant therapy with an INR range of 3.0 to 4.5 in patients after cerebral ischemia of presumed arterial origin is not safe . The efficacy of a lower intensity anticoagulation regimen remains to be determined",
"CONTEXT In patients with nonvalvular atrial fibrillation , warfarin prevents ischemic stroke , but dose adjustment , coagulation monitoring , and bleeding limit its use . OBJECTIVE To compare the efficacy of the oral direct thrombin inhibitor ximelagatran with warfarin for prevention of stroke and systemic embolism . DESIGN , SETTING , AND PARTICIPANTS Double-blind , r and omized , multicenter trial ( 2000 - 2001 ) conducted at 409 North American sites , involving 3922 patients with nonvalvular atrial fibrillation and additional stroke risk factors . INTERVENTIONS Adjusted-dose warfarin ( aim ing for an international normalized ratio [ INR ] 2.0 to 3.0 ) or fixed-dose oral ximelagatran , 36 mg twice daily . MAIN OUTCOME MEASURES The primary end point was all strokes ( ischemic or hemorrhagic ) and systemic embolic events . The primary analysis was based on demonstrating noninferiority within an absolute margin of 2.0 % per year according to the intention-to-treat model . RESULTS During 6405 patient-years ( mean 20 months ) of follow-up , 88 patients experienced primary events . The mean ( SD ) INR with warfarin ( 2.4 [ 0.8 ] ) was within target during 68 % of the treatment period . The primary event rate with ximelagatran was 1.6 % per year and with warfarin was 1.2 % per year ( absolute difference , 0.45 % per year ; 95 % confidence interval , -0.13 % to 1.03 % per year ; P mortality was included in addition to stroke and systemic embolic events , the rate difference was 0.10 % per year ( 95 % confidence interval , -0.97 % to 1.2 % per year ; P = .86 ) . There was no difference between treatment groups in rates of major bleeding , but total bleeding ( major and minor ) was lower with ximelagatran ( 37 % vs 47 % per year ; 95 % confidence interval for the difference , -14 % to -6.0 % per year ; P Serum alanine aminotransferase levels rose to greater than 3 times the upper limit of normal in 6.0 % of patients treated with ximelagatran , usually within 6 months and typically declined whether or not treatment continued ; however , one case of documented fatal liver disease and one other suggestive case occurred . CONCLUSIONS The results establish the efficacy of fixed-dose oral ximelagatran without coagulation monitoring compared with well-controlled warfarin for prevention of thromboembolism in patients with atrial fibrillation requiring chronic anticoagulant therapy , but the potential for hepatotoxicity requires further investigation",
"Transesophageal echocardiography visualizes the left atrium and its appendage and is more sensitive than transthoracic echocardiography for diagnosing thrombi of the left atrium and the left atrial appendage and spontaneous echocardiographic contrast of the left atrium [ 1 - 3 ] . The left atrium and especially the left atrial appendage are the presumed sites of thrombus formation and sources of arterial emboli in patients with atrial fibrillation [ 4 ] . Patients with atrial fibrillation and a history of stroke or embolism were shown to have a higher prevalence of thrombi of the left atrium or the left atrial appendage , a higher prevalence of spontaneous echocardiographic contrast , and a larger left atrial appendage than patients with no history of stroke or embolism [ 2 , 5 , 6 ] . However , whether these abnormalities are predictors for stroke or embolism remains controversial [ 7 , 8 ] . Furthermore , no studies have determined whether transesophageal echocardiography helps to assess risk for stroke or embolism in out patients with atrial fibrillation who have no history of stroke or embolism or whether transesophageal echocardiography is useful in the decision to initiate anticoagulation . We therefore performed a prospect i ve , multicenter study of out patients with atrial fibrillation who had not recently had stroke . We sought to determine whether thrombi of the left atrium or the left atrial appendage , spontaneous echocardiographic contrast , and size of the left atrial appendage are associated with stroke or embolism . Our hypothesis was that patients with thrombi of the left atrium or the left atrial appendage , spontaneous echocardiographic contrast , and enlargement of the left atrial appendage have a higher rate of stroke or embolism than do patients without these abnormalities . The baseline clinical and echocardiographic characteristics of our study sample have been reported elsewhere [ 9 ] . Methods Patient Recruitment Our study was conducted in Austria and Slovakia . At the beginning of the study , general practitioners and internists from surrounding participating centers were informed about the study and were asked to refer patients who had constant or intermittent atrial fibrillation . At each patient 's first visit , a cardiologist recorded baseline data , associated illnesses , clinical characteristics ( definitions of which are listed in Appendix 2 ) , and the cause of atrial fibrillation . A 12-lead electrocardiogram was recorded on 2 separate days . We excluded patients with prosthetic valves and those who were already receiving anticoagulation . Current therapy with aspirin was not an exclusion criterion . Patients who had mitral valve stenosis or had recently had stroke were excluded because anticoagulation was indicated for such conditions . For the definition of recent stroke , we chose a cutoff value of 1 year because a previous study reported that the risk for recurrent stroke was increased in patients who had had an ischemic event in the previous year [ 10 ] . Echocardiography For transthoracic echocardiography , 2.5- or 3.5-MHz probes were used . For M-mode measurements , we applied the recommendations of the American Society of Echocardiography [ 11 ] . M-mode measurements were performed on-line and were documented on printouts . Regional wall-motion and valvular abnormalities were recorded . In patients without regional wall-motion abnormalities , left ventricular systolic function was assessed by calculation of left ventricular fractional shortening . For transesophageal echocardiography , biplane 5-MHz probes were used in 64 % of the patients and monoplane 5-MHz probes were used in 36 % . After local anesthesia with lidocaine spray was administered , the probe was introduced into the nonse date d patients , who lay on their left side . The entire study was recorded on S-VHS videotapes . The cardiac chambers and valves were investigated by using all obtainable views [ 12 , 13 ] . Special care was taken to visualize the whole cavity of the left atrium and its appendage from different planes , with the tip of the probe slightly flexed . The size of the left atrial appendage was measured off-line . A frame that best visualized the left atrial appendage with respect to its orifice , extension , and delineation of borders was selected just before the QRS complex . The length of the left atrial appendage was defined as the distance between the limbus of the left superior pulmonary vein and the apex of the left atrial appendage ; the width of the left atrial appendage was defined as the longest distance between the lateral and ventricular left atrial appendage wall , measured in a line perpendicular to the course of the left atrial appendage curvature ; and the left atrial appendage area was defined as described elsewhere [ 14 ] . For the assessment of intra- and interobserver deviations , left atrial appendage size was measured 1 year after the initial measurement in 20 r and omly selected video recordings by the same observer and in 60 r and omly selected video recordings by three observers from different centers . A thrombus of the left atrium or left atrial appendage was considered definite if at least three of the following five criteria were present : clear borders , echogenicity different from that of surrounding structures , independent mobility , longest diameter greater than 15 mm , and evidence of thrombus in more than one imaging plane [ 15 ] . A second observer from a different center review ed video recordings to confirm diagnosis of thrombus of the left atrium or left atrial appendage . A thrombus was considered probable if only two criteria were present or if the observers disagreed . Spontaneous echocardiographic contrast was diagnosed in the presence of dynamic smoke-like echoes within the left atrium or left atrial appendage with a characteristic swirling motion that was distinct from white noise artifact [ 16 ] . When spontaneous echocardiographic contrast was suspected , the gain setting s were decreased in a stepwise manner to exclude artifact caused by excessive gain . The compression and gain controls were then adjusted to ensure the best possible visualization . Spontaneous echocardiographic contrast was not quantified . A second observer from a different center checked the diagnosis of spontaneous echocardiographic contrast by review ing all video recordings . When the observers disagreed about the presence or absence of spontaneous echocardiographic contrast , the decision made at the time of examination was chosen . This was done because spontaneous echocardiographic contrast was not always visible on review of the video recordings . Outcome Events Primary events were stroke and embolism that extended to viscera or extremities . Stroke was defined as acute onset of a focal neurologic deficit that lasted more than 24 hours and was consistent with a vascular event . Severity and subtypes of stroke were assessed according to established criteria [ 17 ] . Embolism extending to viscera or extremities was defined as a sudden onset of pain that was associated with typical findings on Doppler ultrasonography , angiography , surgery , or autopsy . Secondary events were the need for anticoagulation during follow-up in patients who were primarily receiving aspirin and death not caused by stroke or embolism . Death not caused by stroke or embolism was classified as cardiac or noncardiac on the basis of information from the treating physician and the patient 's family . Follow-up Visits took place 3 , 6 , 12 , 18 , and 24 months after study entry . After a follow-up period of at least 2 years ( ending in February 1994 ) , it was evident that the number of primary outcome events was low . We therefore prolonged the follow-up period and planned further visits , one to be held in 1994 and one to be held in 1995 . Patients who were unwilling or unable to attend the visits were contacted by telephone . Medical records were obtained for patients who had been admitted to a hospital . If a patient had died , an autopsy report or death certificate was obtained . Treatment and Ethical Considerations Although our study was design ed to be observational , we recommended antithrombotic treatment to the patients because of ethical considerations . Because patients with thrombi of the left atrium or left atrial appendage are considered to have a high risk for embolism , we recommended that they receive anticoagulation . The target range for the international normalized ratio was 2.0 to 3.0 , and the treating physicians monitored the ratio [ 5 , 18 ] . We recommended that the remaining patients receive aspirin , 160 mg/d , because preliminary data indicated that aspirin reduces the risk for stroke or embolism in patients with atrial fibrillation [ 19 ] . The institutional review board of the participating centers approved the study . Patients were informed about the background and the procedures of the trial , and informed consent was obtained according to the rules of each center . Statistical Analysis For baseline data , group comparisons were done by analysis of variance for normally distributed data and by the nonparametric Kruskal-Wallis test for data that were not normally distributed . If appropriate , we used the Scheffe post hoc test . The Wilk-Shapiro test was used to check for normality . Contingency table methods , including the chi-square test and the Fisher exact test , were used to analyze categorical data . We used the Cox proportional-hazards model to obtain estimates of relative risk and 95 % CIs for all univariate and multivariate analyses of time-to-event data . All tests were two-sided . The level of significance assumed was an level of 0.05 . We used SAS software ( SAS Institute , Cary , North Carolina ) for analyses . Role of Funding Sources The funding sources had no role in the collection , analysis , or interpretation of the data ; did not review the manuscript at any time ; and were not involved in su bmi tting the paper for publication . Results Patients Patients were recruited between January 1990 and February 1992 . Of the 474",
"PURPOSE R and omized controlled trials have demonstrated that anticoagulant therapy is very effective at preventing stroke among patients with nonrheumatic atrial fibrillation . However , these trials have reported too few strokes for powerful risk factor analysis . Observational studies may provide additional information . The purpose of this study was to identify risk factors in a larger number of patients with stroke and nonrheumatic atrial fibrillation , using case-control methodology . PATIENTS AND METHODS We identified all patients discharged from one hospital over an 8-year period who met our case definition of nonrheumatic atrial fibrillation and ischemic stroke ( n = 134 ) , and compared them with contemporaneous control subjects who were discharged with nonrheumatic atrial fibrillation without stroke ( n = 131 ) . RESULTS Cases and controls were similar in terms of duration of atrial fibrillation ; proportion with paroxysmal atrial fibrillation ; percentage with a past medical history of angina , myocardial infa rct ion , congestive heart failure , diabetes , or smoking ; and mean left atrial size . In contrast , cases were significantly older than controls ( 78.5 versus 74.8 years , p = 0.002 ) and more likely to have a history of hypertension ( 55 % versus 38 % , p = 0.0093 ) . The relative odds for stroke was 1.91 for patients with hypertension , 1.73 for patients older than 75 years , and 3.26 for patients with both factors . CONCLUSIONS Our analysis suggests that age and hypertension should be considered when deciding upon long-term anticoagulant therapy to prevent stroke in patients with nonrheumatic atrial fibrillation",
"BACKGROUND Clinical features that consistently predict ischemic stroke in patients with nonvalvular atrial fibrillation have been identified , while echocardiographic risk factors are less well defined . OBJECTIVE To determine whether the results of transthoracic echocardiography add independent information to the clinical risk factors for stroke in patients with atrial fibrillation . METHODS Transthoracic echocardiographic findings and clinical features from 1066 patients with atrial fibrillation assigned to placebo or control in 3 r and omized trials ( Boston Area Anticoagulation Trial for Atrial Fibrillation , Stroke Prevention in Atrial Fibrillation I Study , and Veterans Affairs Prevention in Atrial Fibrillation Study ) were correlated with subsequent ischemic stroke by multivariate analysis . RESULTS The mean + SD age of patients was 67 + /- 10 years , 78 % were men , 55 % had a history of hypertension , 19 % had a history of diabetes , 7 % had a previous transient ischemic attack or stroke , and 27 % had a history of heart failure . During a mean follow-up of 1.6 years , 78 ischemic strokes occurred ( annual rate , 4.7 % ) . Moderate to severe left ventricular systolic dysfunction shown via 2-dimensional echocardiography was a strong independent predictor of stroke ( relative risk , 2.5 ; P stroke ( relative risk , 1.02/mm ; P = .10 ) . Of 163 patients categorized as low risk based on clinical features ( annual stroke rate , 0.8 % ; 95 % confidence interval , 0.2%-3.0 % ) , 10 had moderate to severe left ventricular dysfunction shown via 2-dimensional echocardiography and a 9.3 % per year risk of stroke ( 95 % confidence interval , 1.3%-66 % ) . Conversely , 728 of the 847 patients at high risk for stroke based on clinical criteria had normal or mildly abnormal left ventricular function ; their stroke rate was 4.4 % ( 95 % confidence interval , 3.4%-5.8 % ) . CONCLUSIONS Left ventricular systolic dysfunction shown via 2-dimensional transthoracic echocardiography independently predicts risk of stroke in patients with atrial fibrillation . Echocardiography may prove most useful in a small group of patients who have a low risk of stroke according to clinical factors",
"BACKGROUND Despite the use of antiplatelet agents , usually aspirin , in patients who have had an ischemic stroke , there is still a substantial rate of recurrence . Therefore , we investigated whether warfarin , which is effective and superior to aspirin in the prevention of cardiogenic embolism , would also prove superior in the prevention of recurrent ischemic stroke in patients with a prior noncardioembolic ischemic stroke . METHODS In a multicenter , double-blind , r and omized trial , we compared the effect of warfarin ( at a dose adjusted to produce an international normalized ratio of 1.4 to 2.8 ) and that of aspirin ( 325 mg per day ) on the combined primary end point of recurrent ischemic stroke or death from any cause within two years . RESULTS The two r and omized study groups were similar with respect to base-line risk factors . In the intention-to-treat analysis , no significant differences were found between the treatment groups in any of the outcomes measured . The primary end point of death or recurrent ischemic stroke was reached by 196 of 1103 patients assigned to warfarin ( 17.8 percent ) and 176 of 1103 assigned to aspirin ( 16.0 percent ; P=0.25 ; hazard ratio comparing warfarin with aspirin , 1.13 ; 95 percent confidence interval , 0.92 to 1.38 ) . The rates of major hemorrhage were low ( 2.22 per 100 patient-years in the warfarin group and 1.49 per 100 patient-years in the aspirin group ) . Also , there were no significant treatment-related differences in the frequency of or time to the primary end point or major hemorrhage according to the cause of the initial stroke ( 1237 patients had had previous small-vessel or lacunar infa rcts , 576 had had cryptogenic infa rcts , and 259 had had infa rcts design ated as due to severe stenosis or occlusion of a large artery ) . CONCLUSIONS Over two years , we found no difference between aspirin and warfarin in the prevention of recurrent ischemic stroke or death or in the rate of major hemorrhage . Consequently , we regard both warfarin and aspirin as reasonable therapeutic alternatives",
"CONTEXT Warfarin has been shown to be highly efficacious for preventing thromboembolism in atrial fibrillation in r and omized trials , but its effectiveness and safety in clinical practice is less clear . OBJECTIVE To evaluate the effect of warfarin on risk of thromboembolism , hemorrhage , and death in atrial fibrillation within a usual care setting . DESIGN Cohort study assembled between July 1 , 1996 , and December 31 , 1997 , and followed up through August 31 , 1999 . SETTING Large integrated health care system in Northern California . PATIENTS Of 13,559 adults with nonvalvular atrial fibrillation , 11,526 were studied , 43 % of whom were women , mean age 71 years , with no known contraindications to anticoagulation at baseline . MAIN OUTCOMES Ischemic stroke , peripheral embolism , hemorrhage , and death according to warfarin use and comorbidity status , as determined by automated data bases , review of medical records , and state mortality files . RESULTS Among 11,526 patients , 397 incident thromboembolic events ( 372 ischemic strokes , 25 peripheral embolism ) occurred during 25,341 person-years of follow-up , and warfarin therapy was associated with a 51 % ( 95 % confidence interval [ CI ] , 39%-60 % ) lower risk of thromboembolism compared with no warfarin therapy ( either no antithrombotic therapy or aspirin ) after adjusting for potential confounders and likelihood of receiving warfarin . Warfarin was effective in reducing thromboembolic risk in the presence or absence of risk factors for stroke . A nested case-control analysis estimated a 64 % reduction in odds of thromboembolism with warfarin compared with no antithrombotic therapy . Warfarin was also associated with a reduced risk of all-cause mortality ( adjusted hazard ratio , 0.69 ; 95 % CI , 0.61 - 0.77 ) . Intracranial hemorrhage was uncommon , but the rate was moderately higher among those taking vs those not taking warfarin ( 0.46 vs 0.23 per 100 person-years , respectively ; P = .003 , adjusted hazard ratio , 1.97 ; 95 % CI , 1.24 - 3.13 ) . However , warfarin therapy was not associated with an increased adjusted risk of nonintracranial major hemorrhage . The effects of warfarin were similar when patients with contraindications at baseline were analyzed separately or combined with those without contraindications ( total cohort of 13,559 ) . CONCLUSIONS Warfarin is very effective for preventing ischemic stroke in patients with atrial fibrillation in clinical practice while the absolute increase in the risk of intracranial hemorrhage is small . Results of r and omized trials of anticoagulation translate well into clinical care for patients with atrial fibrillation"
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41173a84-06ff-11f0-808a-c43d1ab1c353
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Introduction Palmoplantar psoriasis ( PPP ) is a variant of psoriasis that affects the palms and /or soles . Although PPP is a disabling and therapeutically challenging condition , its epidemiology is poorly defined . Aim To assess the prevalence of PPP locations ( palms , soles or both ) , and to analyse epidemiological and clinical characteristics of the disease . Material and methods Two bibliographic data bases ( MEDLINE and SCOPUS ) were used as data sources search ed from inception to October 2017 . The selection of articles was limited to human subjects and English or French language s. Results A search result ed in a total of 293 articles , out of which 24 were utilized for the current systematic review and 21 for meta- analysis . All listed studies comprised a total of 2083 patients with PPP , with more males than females . According to the results of meta- analysis , majority of patients had the highest prevalence of both palms and soles involvement ( 95 % CI : 47 - 67 ) , with an almost equal prevalence showing palmar ( 21 % ; 95 % CI : 13 - 30 ) or plantar ( 20 % ; 95 % CI : 12 - 29 ) involvement . The most prevalent type of PPP was plaque/hyperkeratotic , followed by the pustular type . Conclusions Almost three-fifths ( 59 % ) of all PPP patients had involvement of both palms and soles , while exclusive palmar or plantar involvement was seen in 21 % and 20 % of patients , respectively . Future research should be performed to eluci date basic epidemiological and clinical characteristics of PPP , which would be helpful for proper consideration of this condition
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"BACKGROUND Palmoplantar psoriasis is a difficult to treat variant of plaque psoriasis . OBJECTIVE To study the safety and efficacy of infliximab in non-pustular palmoplantar psoriasis . METHODS Patients with non-pustular palmoplantar psoriasis affecting at least 10 % of their palms and soles and with a modified palmoplantar psoriasis area and severity index ( m-PPPASI ) of at least eight were recruited . Patients were r and omized ( 1:1 ) to receive infliximab 5 mg/kg or placebo at weeks 0 , 2 and 6 . Patients initially r and omized to placebo received infliximab at weeks 14 , 16 and 20 whereas patients r and omized to infliximab received additional infliximab infusions every 8 weeks until week 22 . RESULTS Twenty four ( 24 ) patients were r and omized in this study . At week 14 , 33.3 % and 66.7 % of patients treated with infliximab achieved m-PPPASI 75 and m-PPPASI 50 respectively compared to 8.3 % for both m-PPPASI 75 ( P = 0.317 ) and m-PPPASI 50 ( P = 0.009 ) for patients r and omized to placebo . A reduction of 50.3 % in the mean surface area of palms and soles affected with psoriasis was seen at week 14 in patients r and omized to infliximab as compared to an increase of 14.9 % in patients r and omized to placebo ( P = 0.009 ) . CONCLUSIONS This pilot study did not reach its primary endpoint of m-PPPASI 75 at week 14 . However , infliximab was observed to be more efficacious than placebo in improving PPSA and with respect to the percentage of patients reaching m-PPPASI 50 at week 14 . Larger and longer term studies are needed for severe patients to better assess the efficacy of infliximab in palmoplantar psoriasis",
"Psoriasis is a systematic chronic disease with large influence on patients ' quality of life ( QoL ) . The aim of this study was to assess the QoL of patients with psoriasis using generic , dermatology-specific and psoriasis-specific instruments simultaneously , to investigate the relationships between dimensions or subscales of the question naires and to identify categories of patients at risk of a high QoL impairment . The study comprised 100 consecutive patients with psoriasis treated at the Department of Dermatology , Clinical Center \" Zvezdara \" , Bel grade , from January to December 2011 . Three QoL question naires were administered : the EuroQol-5D ( EQ-5D ) , the Dermatological Life Quality Index ( DLQI ) and the Psoriasis Disability Index ( PDI ) . The Psoriasis Area and Severity Index was used in evaluating disease severity . According to our results the QoL of psoriatic patients was impaired ( the overall DLQI and PDI scores were 10.5 ± 7.2 and 13.4 ± 8.7 , respectively , while EQ visual analog scale score was 48.8 ± 25.1 ) . The most predictive factor of QoL impairment was disease severity , followed by sole and nail involvement . Psoriatic arthritis and bleeding were also associated with impaired QoL. Significant correlations between the instruments used in this study were in the expected directions . Mainly strong and moderate significant correlations ranging 0.26 - 0.84 were seen between DLQI and PDI instruments . A detailed approach to QoL assessment may give to the dermatologist useful information that could be of help in identifying patients belonging to categories at risk of high QoL impairment due to psoriasis , thus guiding them in clinical practice",
"BACKGROUND Psoriasis is a common and chronic T cell mediated skin disorder with varied clinico-morphological types . Most of the published studies have reported chronic plaque type psoriasis to be the commonest type . AIM To find the incidence of palmoplantar psoriasis in a tertiary health care centre in South India . MATERIAL S AND METHODS A prospect i ve study done over a period of six months recruiting the patients attending the Dermatology out-patient department in a tertiary health care centre . RESULTS Incidence of palmoplantar psoriasis was found to be highest among all morphological forms of psoriasis . CONCLUSION Incidence of palmoplantar psoriasis is under-expressed . It is actually ahead in the race",
"Background : Plaque psoriasis affecting palms and soles is disabling and often resistant to treatment . Objective : Evaluate the efficacy and safety of secukinumab , an anti‐interleukin 17A antibody , in subjects with palmoplantar psoriasis . Methods : In this double‐blinded , r and omized controlled trial , 205 subjects were r and omized 1:1:1 to secukinumab 300 mg , 150 mg , or placebo . The primary endpoint was Palmoplantar Investigator 's Global Assessment ( ppIGA ) 0 ( clear ) or 1 ( almost clear/minimal ) response at week 16 . Results : At week 16 , the percentage of subjects who achieved clear or almost clear palms and soles ( or ppIGA 0/1 ) with secukinumab 300 mg ( 33.3 % ) and 150 mg ( 22.1 % ) was superior to the percentage achieved with placebo ( 1.5 % , P ) . Palmoplantar Psoriasis Area and Severity Index ( ppPASI ) was significantly reduced with secukinumab 300 mg ( −54.5 % ) and 150 mg ( −35.3 % ) compared with placebo ( −4.0 % , P 0/1 responses from subjects in the secukinumab groups were also significantly higher compared with placebo at week 16 ( P was markedly improved with secukinumab as measured by the palmoplantar Quality ‐of‐Life Instrument . Secukinumab 300 mg consistently showed the best outcomes . The safety profile was favorable and similar to previous studies . Limitations : Lack of active comparator . Conclusion : In GESTURE , the largest r and omized controlled trial in palmoplantar psoriasis , secukinumab demonstrated the greatest efficacy to date for treating difficult‐to‐treat psoriasis",
"BACKGROUND Palmoplantar psoriasis ( PP ) is a chronic , inflammatory and proliferative dermatosis of the palms and /or soles with significant morbidity . It is notoriously difficult to treat and unresponsive to traditional topical agents . MATERIAL AND METHODS This was a prospect i ve , r and omized study involving 111 patients of psoriasis with significant palmoplantar disease . Patients meeting the eligibility criteria were r and omly assigned to one of the two treatment groups . Patients in Group I received methotrexate in doses of 0.4 mg/kg weekly , and patients in Group II received acitretin in doses of 0.5 mg/kg daily . Patients were evaluated by modified PPPASI ( m-PPPASI ) score for palm and sole involvement at baseline , at two weekly intervals for the first 4 weeks and then four weekly for next 8 weeks . Treatment protocol was continued for a period till patient achieved 75 % reduction in m-PPPASI from baseline or 12 weeks whichever was earlier . RESULTS There was a statistically significant difference in reduction of m-PPPASI of patients on methotrexate at weeks 8 and 12 . The mean m-PPPASI at week 8 was 15.38 ± 6.08 in methotrexate group and 17.23 ± 5.25 in acitretin group ( P = 0.04 ) . The mean m-PPPASI at week 12 was 10.30 ± 5.97 in methotrexate group and 12.40 ± 5.31 in acitretin group ( P = 0.03 ) . Marked improvement ( m-PPPASI 75 ) was achieved in 12 ( 24 % ) patients in methotrexate group compared with 4 ( 8 % ) in acitretin group which was statistically significant ( P = 0.029 ) . Adverse events were generally mild and were seen in 14 patients in methotrexate group and 15 patients in acitretin group ( P = 0.080 ) . CONCLUSION Methotrexate is relatively inexpensive , safe and efficacious drug for the treatment of psoriasis patients with significant palmoplantar involvement . Acitretin can be used as an alternative therapy and with a good safety profile",
"The levels of proelafin peptides in the sera of patients with pustulosis palmoplantaris , a unique type of localized pustular psoriasis , and generalized pustular psoriasis were determined by competitive enzyme-linked immunosorbent assays using antibodies against synthetic proelafin polypeptides corresponding to the elastase inhibitor ( elafin ) and transglutaminase substrate domains . The sera of patients with pustulosis palmoplantaris ( 9 cases ) exhibited a normal range of proelafin peptide levels . The sera of patients with generalized pustular psoriasis ( 3 cases ) showed high titres of proelafin peptide . There were no large differences in the titres between the 2 antibodies . The antibodies for 2 different domains of proelafin showed a similar immunoreactivity for the non-pustular region of the epidermis in all pustulosis palmoplantaris tested . The results indicate that serum proelafin peptides in pustular psoriasis may depend on the extent of the involved area , and that proelafin peptide level in pustulosis palmoplantaris remains normal despite enhanced local expression in the lesional skin . Since the skin lesions of patients with pustulosis palmoplantaris are limited to the palms and soles , enhanced expression of proelafin in the lesional skin may not lead to elevation of proelafin peptides in the serum",
"BACKGROUND Both bath psoralen plus ultraviolet A ( PUVA ) and oral PUVA with 8-methoxypsoralen ( 8-MOP ) have been successfully used for the treatment of recalcitrant palmoplantar psoriasis . This trial was design ed to assess the efficacy and side effects of the different treatment modalities in a r and omized half-side comparison . METHODS Eight patients with moderate-to-severe psoriasis on soles ( n = 6 ) and /or palms ( n = 8) were r and omly assigned to receive bath PUVA treatment on one side and oral PUVA on the other . Initial treatment dose was 50 % of the minimal phototoxic dose evaluated for bath PUVA and oral PUVA . Treatment was given three times a week for 4 weeks . Before treatment and every week a severity index ( SI ) was assessed by summing the scores of erythema , infiltration , scaling and vesicles evaluated on a scale from 0 to 4 . After 4 weeks of treatment the half-side trial was finished and the treatment was continued on both sides with the more effective treatment regimen . RESULTS Both bath PUVA and oral PUVA achieved a reduction of the mean initial SI from 5.9 ( 95 % confidence intervals ( CI ) 4.5 - 8.0 ) to 3.3 ( 1.8 - 6.0 ) ( 44 % SI reduction , P better effect in lesions treated with oral PUVA compared with bath PUVA ( P = 0.033 ) . However , at 4 weeks , there was no significant difference between the achieved SI reduction of oral PUVA and bath PUVA . Systemic side effects ( nausea and /or dizziness ) were only observed after oral PUVA . CONCLUSION This study gives evidence that in the first 4 treatment weeks oral PUVA is slightly more effective than bath PUVA but the former has more systemic side effects",
"Abstract Background : Plaque-type palmoplantar psoriasis ( PPTP ) is a chronic recalcitrant dermatosis with treatment modalities ranging through topical , phototherapy or systemic . Phototherapy options include various forms of ultraviolet B ( UVB ) and ultraviolet A with prior psoralen sensitization ( PUVA ) . Currently , few comparative studies have been reported . Purpose : To compare Broad-B and UVB ( BB-UVB ) versus paint PUVA ( p-PUVA ) in regard to efficacy and safety in the treatment of PPTP . Methods : A retrospective non-r and omized cohort study comprised of all the patients with PPTP treated in our phototherapy centre during 2010–2012 , either with BB-UVB or p-PUVA . Results : Among the 248 patients included in this study , 122 received BB-UVB and 126 followed p-PUVA treatment . About 36 ( 30 % ) and 53 ( 42 % ) had complete remission , 29 ( 24 % ) and 59 ( 47 % ) responded partially and 57 ( 47 % ) and 14 ( 11 % ) patients did not improve with BB-UVB and p-PUVA , respectively . The odds ratio for remission ( p-PUVA : BB-UVB ) was 7.9 . Duration of remission was 21.9 ± 1.34 months for p-PUVA and 16.75 ± 1.83 months for BB-UVB . Conclusion : Both BB-UVB and p-PUVA are good therapeutic options for PPTP . P-PUVA emerges as the superior treatment modality , yielding a better and more extended response . BB-UVB represents a feasible alternative in patients with milder disease or possible contraindications for p-PUVA ",
"Topical methoxsalen photochemotherapy has been assessed in 22 patients suffering from recalcitrant palmoplantar pustulosis or psoriasis predominantly involving the h and s and feet . Although 20 out of 22 patients improved and good results were obtained in exactly half of those treated , only 4 patients were classified as being \" clear \" or \" minimally involved \" at the end of 12 weeks . Two patients have shown no improvement at all . Minor local side effects were relatively common and included symptomatic erythema , blistering and local pigmentation . The histological findings in post PUVA treated skin are discussed and the pros and cons of topical photochemotherapy in this group of diseases is review ed",
"Seventeen patients with palmoplantar pustular psoriasis and three with hyperkeratotic psoriasis of palms and soles were treated with either PUVA‐etretinate ( 1 mg/kg ) or PUVA‐placebo . Patients were r and omly allocated to each group and the trial was conducted according to a double‐blind protocol , so far as the side‐effects of etretinate made this possible . PUVA was given three times a week for a maximum of 18 weeks , after 2 weeks on daily placebo or etretinate alone . All ten patients in the PUVA‐etretinate group cleared , but there were four failures in the PUVA‐placebo group ( P=0.03 ) . The PUVA‐etretinate treated patients required significantly fewer PUVA treatments ( 13.1 ± 2.9 ; mean ± s.e . ) and cleared in a significantly shorter time ( 30.3 ± 7.1 days ) than the PUVA‐placebo group ( 23.2 ± 4.2 treatments ; 59.2 ± 11.5 days , P was less in the PUVA‐etretinate group ( 53.9 ± 18.5 J/cm2 ) than the PUVA‐placebo group ( 113.1 ± 33.4 J/cm2 ) . This difference was not significant due to the exceptionally large dose of UV‐A used on one patient but the results were significant when it was excluded",
"BACKGROUND Palmoplantar psoriasis ( PPP ) is a disabling condition which is usually resistant to most of the available therapeutic modalities . Coal tar is an accepted therapy for psoriasis which has not been well studied for PPP . METHODS Thirty patients with a plaque type of PPP were allocated into two groups : Group A ( 19 patients ) were treated with 6 % crude coal tar ( CCT ) ointment and Group B ( 11 patients ) were treated with white petrolatum and salicylic acid . In both groups , ointment was applied and left on overnight . Wearing of gloves and socks during the night and application of emollients in the day was routinely advised . The lesions were assessed for erythema , scaling , and in duration ( ESI ) every 2 weeks for a total of 8 weeks . Patients with greater than 50 % improvement were considered to have good improvement . Side-effects , if any , were also monitored . RESULTS In Group A , 76.5 % of patients ( 13/17 ) showed good improvement , whereas only 45.5 % of patients ( 5/11 ) in Group B showed the same magnitude of improvement ( P side-effects were reported by any patient in either of the groups . CONCLUSIONS Crude coal tar is a safe , effective , and inexpensive modality for the treatment of PPP . We recommend coal tar under occlusion , along with the liberal use of emollients , as the first line of therapy for all cases of PPP"
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Introduction Iron deficiency is the most prevalent nutrient deficiency in the world , particularly during pregnancy . According to the literature , anemia , particularly severe anemia , is associated with increased risk of maternal mortality . It also puts mothers at risk of multiple perinatal complications . Numerous studies in the past have evaluated the impact of supplementation with iron and iron-folate but data regarding the efficacy and quality of evidence of these interventions are lacking . This article aims to address the impact of iron with and without folate supplementation on maternal anemia and provides outcome specific quality according to the Child Health Epidemiology Reference Group ( CHERG ) guidelines . Methods We conducted a systematic review of published r and omized and quasi-r and omized trials on PubMed and the Cochrane Library as per the CHERG guidelines . The studies selected employed daily supplementation of iron with or without folate compared with no intervention/placebo , and also compared intermittent supplementation with the daily regimen . The studies were abstract ed and grade d according to study design , limitations , intervention specifics and outcome effects . CHERG rules were then applied to evaluate the impact of these interventions on iron deficiency anemia during pregnancy . Recommendations were made for the Lives Saved Tool ( LiST ) . Results After screening 3550 titles , 31 studies were selected for assessment using CHERG criteria . Daily iron supplementation result ed in 73 % reduction in the incidence of anemia at term ( RR = 0.27 ; 95 % CI : 0.17 – 0.42 ; r and om effects model ) and 67 % reduction in iron deficiency anemia at term ( RR = 0.33 ; 95 % CI : 0.16 – 0.69 ; r and om model ) compared to no intervention/placebo . For this intervention , both these outcomes were grade d as ‘ moderate ’ quality evidence . Daily supplementation with iron-folate was associated with 73 % reduction in anemia at term ( RR = 0.27 ; 95 % CI : 0.12 – 0.56 ; r and om model ) with a quality grade of ‘ moderate ’ . The effect of the same intervention on iron deficiency anemia was non-significant ( RR = 0.43 ; 95 % CI : 0.17 – 1.09 ; r and om model ) and was grade d as ‘ low ’ quality evidence . There was no difference in rates of anemia at term with intermittent iron-folate vs. daily iron-folate supplementation ( RR = 1.61 ; 95 % CI : 0.82 –3.14 ; r and om model ) . Conclusion Applying the CHERG rules , we recommend a 73 % reduction in anemia at term with daily iron ( alone ) supplementation or iron/folate ( combined ) vs. no intervention or placebo ; for inclusion in the LiST model . Given the paucity of studies of intermittent iron or iron-folate supplementation , especially in developing countries , we recommend further evaluation of this intervention in comparison with daily supplementation regimen
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"Two hundred Hausa primigravidae at Zaria were divided into five groups in a r and omized double-blind trial of antenatal oral antimalarial prophylaxis , and haematinic supplements . Group 1 received no active treatment . Groups 2 to 5 were given chloroquine 600 mg base once , followed by proguanil 100 mg per day . In addition , group 3 received iron 60 mg daily , group 4 folic acid 1 mg daily , and group 5 iron plus folic acid . Forty-five percent were anaemic ( haemoglobin ( Hb ) less than 11.0 g dl-1 ) at first attendance before 24 weeks of gestation , and malaria parasitaemia ( predominantly Plasmodium falciparum ) was seen in 27 % , of whom 60 % were anaemic . The mean Hb fell during pregnancy in group 1 , and seven patients in this group had to be removed from the trial and treated for severe anaemia ( packed cell volume ( PCV ) less than 0.26 ) . Only five patients in the other groups developed severe anaemia ( P = 0.006 ) , two of whom had malaria following failure to take treatment . Patients in group 1 had the lowest mean Hb at 28 and 36 weeks of gestation , and patients receiving antimalarials and iron ( groups 3 and 5 ) had the highest Hb at 28 weeks , but differences were not significant , possibly due to removal from the trial of patients with severe anaemia . Anaemia ( Hb less than 12.0 g dl-1 ) at six weeks after delivery was observed in 61 % of those not receiving active treatment ( group 1 ) , in 39 % of those protected against malaria but not receiving iron supplements ( groups 2 and 4 ) and in only 18 % of patients receiving both antimalarials and iron ( groups 3 and 5 ) . Folic acid had no significant effect on mean Hb . Proguanil was confirmed to be a highly effective causal prophylaxis . Prevention of malaria , without folic acid supplements , reduced the frequency of megaloblastic erythropoiesis from 56 % to 25 % . Folic acid supplements abolished megaloblastosis , except in three patients who were apparently not taking the treatment prescribed . Red cell folate ( RCF ) concentrations were higher in subjects with malaria , probably due to intracellular synthesis by plasmodia . Infants of mothers not receiving antimalarials appeared to have an erythroid hyperplasia . Maternal folate supplements raised infants ' serum folate and RCF . Fourteen per cent had low birth weight ( less than 2500 g ) , and the perinatal death rate was 11 % ; the greatest number were in group 1 , but not significantly . A regime is proposed for the prevention of malaria , iron deficiency , folate deficiency and anaemia in pregnancy in the guinea savanna of Nigeria",
"Background Deficiencies of iron and folic acid during pregnancy can lead to adverse outcomes for the fetus , thus supplements are recommended . Adherence to current tablet-based supplements is documented to be poor . Recently a powdered form of micronutrients has been developed which may decrease side-effects and thus improve adherence . However , before testing the efficacy of the supplement as an alternate choice for supplementation during pregnancy , the bioavailability of the iron needs to be determined . Our objective was to measure the relative bioavailability of iron and folic acid from a powdered supplement that can be sprinkled on semi-solid foods or beverages versus a traditional tablet supplement in pregnant women . Methods Eighteen healthy pregnant women ( 24 – 32 weeks gestation ) were r and omized to receive the supplements in a crossover design . Following ingestion of each supplement , the changes ( over baseline ) in serum iron and folate over 8 hours were determined . The powdered supplement contained 30 mg of iron as micronized dispersible ferric pyrophosphate with an emulsifier coating and 600 μg folic acid ; the tablet contained 27 mg iron from ferrous fumarate and 1000 μg folic acid . Results Overall absorption of iron from the powdered supplement was significantly lower than the tablet ( p = 0.003 ) . There was no difference in the overall absorption of folic acid between supplements . Based on the differences in the area under the curve and doses , the relative bioavailability of iron from powdered supplement was lower than from the tablet ( 0.22 ) . Conclusion The unexpected lower bioavailability of iron from the powdered supplement is contrary to previously published reports . However , since pills and capsules are known to be poorly accepted by some women during pregnancy , it is reasonable to continue to explore alternative micronutrient delivery systems and forms of iron for this purpose .Trial Registration Clinical Trials.gov",
"RATIONALE It has been suggested that in pregnant women weekly iron supplements are as effective as daily supplements in preventing iron deficiency anaemia ( IDA ) . OBJECTIVE To compare the effectiveness of prophylactic antenatal oral iron supplements given weekly , thrice weekly and daily in preventing IDA in pregnancy . DESIGN A r and omised control trial . SETTING University antenatal clinic , ( UANC ) Galle . SUBJECTS AND METHOD An oral iron supplement containing 100 mg of elemental iron was r and omly given weekly ( n = 26 ) thrice weekly ( n = 35 ) and daily ( n = 31 ) to 92 women who were 14 to 24 weeks pregnant . Haemoglobin ( Hb ) , serum ferritin ( SF ) and haematocrit ( Hct ) were assessed before and after 12 to 20 weeks of supplementation and a logistic regression analysis carried out . RESULTS The risk of developing anaemia was significantly higher in the weekly ( odds ratio 15 , 95 % CI 1.4 - 165.6 , p risk of developing iron deficiency ( SF Prophylactic oral iron supplements when given intermittently were not effective in preventing iron deficiency anaemia in pregnancy",
"Iron deficiency is one of the main causes of anemia during pregnancy , although other micronutrient deficiencies may play a role . We examined the effects of daily antenatal and postnatal supplementation with four combinations of micronutrients on maternal hematologic indicators in a double-masked r and omized controlled community trial . Communities , called sectors , were r and omly assigned to supplementation with folic acid ( 400 microg ) , folic acid plus iron ( 60 mg ) , folic acid plus iron and zinc ( 30 mg ) and folic acid plus iron , zinc and 11 other micronutrients , each at the approximate recommended daily allowance for pregnancy all given with vitamin A as retinol acetate ( 1000 microg retinol equivalent ) , or vitamin A alone as the control group . Hemoglobin ( Hb ) and indicators of iron status were assessed at baseline and at 32 wk of gestation . At 6-wk postpartum , Hb assessment was repeated using a finger stick . Severely anemic women ( Hb were treated according to WHO recommendations . Folic acid alone had no effect on maternal anemia or iron status . Hb concentrations were 14 g/L , [ 95 % confidence limits ( CL ) , 8.3 - 19.2 ] , 10.0 g/L ( CL , 5.2 - 14.8 ) and 9.4 g/L ( CL , 4.7 - 14.1 ) higher in the groups receiving folic acid plus iron , folic acid plus iron and zinc and folic acid plus iron , zinc and multiple micronutrients , respectively , relative to the control . Anemia in the third trimester was reduced by 54 % with folic acid plus iron , by 48 % with folic acid plus iron and zinc and by 36 % with folic acid plus iron , zinc and multiple micronutrients supplementation , relative to the control ( P folic acid plus iron and zinc and folic acid plus iron , zinc and multiple micronutrients provided no additional benefit in improving maternal hematologic status during pregnancy compared with folic acid plus iron . The level of compliance and baseline Hb concentrations modified the effect of iron",
"The effect of daily rather than weekly iron supplementation was compared in women who were 8 - 24 wk pregnant . One group ( n = 68 ) received 60 mg Fe/d , the second group ( n = 71 ) received 120 mg Fe/wk , given at once . Supplementation lasted 11.3 wk on average , depending on gestational date at entry , and was not supervised . Hemoglobin increased in both groups ( P serum ferritin did not change significantly . There was no significant difference between groups for changes in hemoglobin and serum ferritin . In a subgroup of women with a hemoglobin concentration ( n = 45 daily ; n = 54 weekly ) no significant within-group changes occurred in serum ferritin , but the change in the daily group was 4.1 micrograms/L higher than in the weekly group ( P = 0.049 ) . Compliance , as indicated by two positive stool tests , was approximately equal to 54.3 % in the daily group and 62.2 % in the weekly group . We conclude that for the complete sample of subjects , the treatment effect of daily compared with weekly supplementation was similar under conditions resembling a normal antenatal care program",
"Studies on the treatment and prevention of iron deficiency anemia , in pregnant and nonpregnant women and in men , were conducted in Thail and and Burma . The effects of the dose of Fe , duration of Fe administration , additional supplementation with folate , mode of supplement delivery ( either supervised or unsupervised ) , and the presence of Hb(AE ) were studied . The frequency and severity of side effects were also recorded . Fe administration result ed in an increase in hemoglobin concentration in all anemic individuals but approximately 20 % failed to reach normality . The length of administration and the dose influenced the results . Frequency and severity of side effects increased with the dose of Fe administered . Folate supplementation did not affect the results . It appears possible to integrate a program of prevention and treatment of Fe deficiency anemia in a primary health-care system but the constraints and limitations of achievable results should be recognized",
"BACKGROUND In Korea , it is customary to prescribe iron and folic acid supplements to pregnant women after the 20th wk of gestation ; however , little evidence exists to support this practice . OBJECTIVE The objective was to determine the effects of time of initiation and dose of prenatal iron and folic acid supplementation on the iron and folate nutriture of Korean women during pregnancy . DESIGN A total of 131 pregnant women were placed into 1 of 5 experimental groups , either the control group or 1 of 4 supplemented groups . The supplemented groups varied by time of initiation , which was either during the first trimester or at week 20 of gestation , and by dose of iron and folic acid supplements provided , which consisted of either 30 mg Fe plus 175 microg folic acid or 60 mg Fe plus 350 microg folic acid . All supplemented groups continued supplementation until delivery . RESULTS Improvements in iron and folate nutriture were highly dependent on when the supplement program was initiated , but both supplement doses were equally effective . In contrast , the influence of folic acid supplementation on maternal folate status was not as pronounced as was the influence of iron supplementation on iron status . CONCLUSION In pregnant Korean women , initiating iron and folic acid supplementation earlier during pregnancy may prevent the deterioration of iron and folate nutriture more than does increasing supplement doses in later stages of pregnancy",
"BACKGROUND Nightblindness affects 16 - 52 % of pregnant women in areas of Nepal and in some cases persists after vitamin A treatment . Iron and riboflavin affect vitamin A utilization and photoreceptor function , respectively , and pilot data in the study population showed a high prevalence of iron and riboflavin deficiencies . OBJECTIVE The objective was to assess the effect of supplemental iron and riboflavin on pupillary threshold ( PT ) and plasma retinol in nightblind , pregnant Nepali women given vitamin A-fortified rice . DESIGN Nightblind pregnant women were r and omly assigned to receive , 6 d/wk under supervision for 6 wk , a vitamin A-fortified rice curry dish providing 850 microg retinal activity equivalents/d with either a 30-mg Fe and 6-mg riboflavin ( FeR + VA ) capsule or a placebo control ( VA only ) capsule . Hemoglobin , erythrocyte riboflavin , and plasma ferritin and retinol were measured before and after the intervention . Dark adaptation was assessed by PT score . RESULTS Women who were iron deficient at baseline ( n=38 ) had significantly greater improvement in PT score with iron and riboflavin supplementation than without ( P=0.05 ) . Iron and riboflavin supplements significantly reduced the prevalences of riboflavin deficiency ( from 60 % to 6 % ; P iron deficiency anemia ( from 35 % to 15 % ; P abnormal PT ( from 87 % to 30 % ; P erythrocyte riboflavin ( P plasma ferritin ( P=0.01 ) were greater in the FeR + VA group than in the VA only group . CONCLUSIONS Iron deficiency may limit the efficacy of vitamin A to normalize dark adaptation in pregnant Nepali women . Further studies are needed to assess the effect of simultaneous delivery of iron and vitamin A for the treatment of nightblindness",
"The usefulness of serum ferritin levels in assessing iron stores in pregnant women before and after supplementation with iron was studied . One hundred thirty-five healthy pregnant women between 22 to 28 wk were r and omly allotted to daily dose regimes of 60 , 120 , or 240 mg of ferrous sulphate . The tablets were given after meals under strict personal supervision . Before supplementation , iron deficiency ( ferritin level less than 10 micrograms/L ) was present in 54.8 % of the pregnant women , compared to an incidence of 17.8 % when assessed by serum iron concentration of less than 50 micrograms/dl . The mean ferritin level of pregnant women was 14.15 micrograms/L and was less than one-half that of healthy single women and one-sixth of that of healthy males . Supplementation with oral iron for 12 wk produced an increase in ferritin levels in all the groups , but significant increases were seen only in women given 120 and 240 mg of ferrous sulphate with or without folic acid . However , there were no differences in final Hb levels among the supplemented groups",
"We studied the effect of iron supplementation on the iron status of mothers and on biochemical iron status and clinical and anthropometric measures in their infants . The subjects were 197 pregnant women selected at 28 wk + /- 21 d of gestation at a mother- and -child health center in Niamey , Niger . Ninety-nine women received 100 mg elemental Fe/d throughout the remainder of their pregnancies and 98 received placebo . The prevalence of anemia and iron deficiency decreased markedly during the last trimester of pregnancy in the iron-supplemented group but remained constant in the placebo group . Three months after delivery , the prevalence of anemia was significantly higher in the placebo group . At delivery , there were no differences between the two groups in cord blood iron variables . Three months after delivery , serum ferritin concentrations were significantly higher in infants of women in the iron-supplemented group . Mean length and Apgar scores were significantly higher in infants with mothers in the iron group than in those with mothers in the placebo group",
"BACKGROUND According to our current underst and ing , iron absorption with weekly iron supplements is not higher than that with daily supplements ( ie , there is no mucosal block ) . However , community-based trials have repeatedly shown that a weekly regimen is as effective as a daily one . Furthermore , when differences in absorption are found , they are commonly smaller than would be expected on the basis of differences in the amount of iron provided . The possibility of differential compliance between the regimens needs to be evaluated to explain these findings . OBJECTIVE Taking compliance into account , we compared the efficacy and trial effectiveness of weekly and daily iron supplementation during pregnancy . DESIGN In Bangladesh , 50 antenatal centers were r and omly assigned to prescribe either 2 doses of 60 mg Fe once weekly or 1 dose of 60 mg Fe/d . Compliance was monitored by using a pill bottle equipped with an electronic counting device . Hemoglobin concentrations were measured at baseline and after 4 , 8 , and 12 wk of supplementation . RESULTS There was no differential effect per iron tablet between weekly and daily regimens . A 12-wk daily regimen ( 68 % compliance ) produced a small but significantly greater hemoglobin response than did the weekly regimen ( 104 % compliance ) . The first 20 tablets consumed produced most of the effect ; after 40 tablets , there was no further response . CONCLUSIONS There was no evidence of a mucosal block in the daily regimen . Over 12 wk , 50 % of the amount of iron in a daily regimen was sufficient for maximum hemoglobin effect . The weekly regimen provided a large part of this amount , explaining the limited difference in effect . It appears that the current international recommendation for iron supplementation in pregnancy is higher than necessary",
"Limited adherence to iron supplementation is thought to be a major reason for the low effectiveness of anemia-prevention programs . In rural Tanzania , women at 21 - 26 wk of gestation were r and omly given either 120 mg of a conventional ( Con ) iron supplement or 50 mg of a gastric-delivery-system ( GDS ) iron supplement for 12 wk . Adherence was assessed by using a pill bottle equipped with an electronic counting device . Adherence in the GDS group was 61 % compared with 42 % for the Con group . In both groups , women experiencing side effects had about one-third lower adherence . Fewer side effects were observed in the GDS group . In a subgroup of women with a low initial hemoglobin concentration ( hematologic response in a population with a marginal hemoglobin concentration . The GDS group appeared to require a dose one-fourth as high as that of the Con group for an equal effect on improving hemoglobin to normal concentrations",
"BACKGROUND The need for prophylactic iron during pregnancy is uncertain . OBJECTIVE We tested the hypothesis that administration of a daily iron supplement from enrollment to 28 wk of gestation to initially iron-replete , nonanemic pregnant women would reduce the prevalence of anemia at 28 wk and increase birth weight . DESIGN Between June 1995 and September 1998 , 513 low-income pregnant women in Clevel and were enrolled in the study before 20 wk of gestation . Of these , 275 had a hemoglobin concentration > /= 110 g/L and a ferritin concentration > /= 20 micro g/L and were r and omly assigned to receive a monthly supply of capsules containing either 30 mg Fe as ferrous sulfate or placebo until 28 wk of gestation . At 28 and 38 wk of gestation , women with a ferritin concentration of 12 to infant birth weight and gestational age at delivery for 117 and 96 of the 146 and 129 women r and omly assigned to receive iron and placebo , respectively . RESULTS Compared with placebo , iron supplementation from enrollment to 28 wk of gestation did not significantly affect the overall prevalence of anemia or the incidence of preterm births but led to a significantly higher mean ( + /- SD ) birth weight ( 206 + /- 565 g ; P = 0.010 ) , a significantly lower incidence of low-birth-weight infants ( 4 % compared with 17 % ; P = 0.003 ) , and a significantly lower incidence of preterm low-birth-weight infants ( 3 % compared with 10 % ; P = 0.017 ) . CONCLUSION Prenatal prophylactic iron supplementation deserves further examination as a measure to improve birth weight and potentially reduce health care costs",
"BACKGROUND Iron deficiency anemia ( IDA ) is common in pregnant women , but previous trials aim ed at preventing IDA used high-dose iron supplements that are known to cause gastrointestinal side effects . OBJECTIVE The objective was to assess the effect on maternal IDA and iron deficiency ( ID , without anemia ) of supplementing pregnant women with a low dosage ( 20 mg/d ) of iron . Effects on iron status were assessed at the time of delivery and at 6 mo postpartum . Gastrointestinal side effects were assessed at 24 and 36 wk of gestation . DESIGN This was a r and omized , double-blind , placebo-controlled trial of a 20-mg daily iron supplement ( ferrous sulfate ) given from 20 wk of gestation until delivery . RESULTS A total of 430 women were enrolled , and 386 ( 89.7 % ) completed the follow-up to 6 mo postpartum . At delivery , fewer women from the iron-supplemented group than from the placebo group had IDA [ 6/198 , or 3 % , compared with 20/185 , or 11 % ; relative risk ( RR ) : 0.28 ; 95 % CI : 0.12 , 0.68 ; P ID ( 65/186 , or 35 % , compared with 102/176 , or 58 % ; RR : 0.60 ; 95 % CI : 0.48 , 0.76 ; P gastrointestinal side effects between groups . At 6 mo postpartum , fewer women from the iron-supplemented group had ID ( 31/190 , or 16 % , compared with 51/177 , or 29 % ; RR : 0.57 ; 95 % CI : 0.38 , 0.84 ; P rate of IDA between the groups did not differ significantly at 6 mo postpartum . CONCLUSION Supplementing the diet of women with 20 mg Fe/d from week 20 of pregnancy until delivery is an effective strategy for preventing IDA and ID without side effects",
"BACKGROUND There is a growing interest in periconceptional iron supplementation in developing countries by research ers and policy makers ; however , there are no r and omized controlled trials that examine the effectiveness of this strategy in decreasing anemia during pregnancy . OBJECTIVE The aim was to determine whether periconceptional iron supplementation reduces anemia during pregnancy . DESIGN A r and omized , double-blind , controlled trial was conducted in rural Bangladesh . Married , Noneiparous women were r and omly assigned to receive daily iron and folic acid ( IFA ; 60 mg ferrous fumarate and 400 microg folic acid ) ( n = 134 ) or folic acid ( FA ; 400 microg ) ( n = 138 ) in the form of a powdered supplement added to food . Women were followed until pregnancy or the end of 9 mo . Primary outcomes included hemoglobin , plasma ferritin , and plasma transferrin receptor concentrations . RESULTS Among 88 pregnant women , periconceptional IFA in comparison with FA did not affect anemia or iron status at 15 wk gestation . However , each 1 % increase in adherence was associated with a 10-g/L increase in change in hemoglobin from baseline ( P = 0.03 ) , and those who initiated supplementation at a mean ( + /-SD ) time of 72.9 + /- 57.8 d before conception showed a 7.3-g/L increase in change in hemoglobin from baseline compared with those who initiated supplementation at 26.3 + /- 12.3 d after conception ( P = 0.01 ) . Among 146 nonpregnant women , IFA decreased anemia ( odds ratio : 0.19 ; 95 % CI : 0.04 , 0.95 ) and improved iron stores ( P = 0.001 ) more than did FA . CONCLUSION Good adherence and initiation of supplementation before conception are needed to reduce anemia during early pregnancy . This trial was registered at www . clinical trials.gov as NCT00953134",
" Summary . Serum iron , serum iron‐binding capacity , serum ferritin and erythrocyte protoporphyrin were determined during uncomplicated pregnancy in 45 healthy women ; 22 were given oral iron while the others were given a placebo . When iron was not given , 15 out of 23 women had exhausted iron stores and iron deficiency at term , as judged from low serum ferritin , low serum transferrin saturation and high erythrocyte protoporphyrin values . Only seven of them had a haemoglobin concentration between 10 and 11 g/dl at term but none had values developed iron deficiency . Serum ferritin was the most sensitive and specific test of iron deficiency . A practical procedure to detect iron deficiency and to control iron supplementation in pregnancy is suggested",
" Eighty-one pregnant or lactating women living in a village in The Gambia were allocated to treatment groups to receive a daily placebo , riboflavin , ferrous sulphate or ferrous sulphate plus riboflavin . At the beginning of the study and at 3 and 6 weeks thereafter women were examined clinical ly and blood sample s collected for haematological and biochemical measurements . Pregnant women showed a wide range of response to supplement but among the lactating women an interesting pattern emerged : whereas the haematological status of the placebo group declined over 6 weeks , in the group receiving iron supplements this deterioration was reduced although not significantly . Riboflavin given in addition to iron result ed in a significant increase in circulating plasma iron and in iron stores , relative to the placebo",
"The iron ( Fe ) nutritional status of 203 healthy pregnant women was assessed at the first prenatal visit ( To ) ( gestational age : 16.9 weeks + /- 3.81 . Women were r and omly assigned to one of three groups : G1 and G2 were supplemented with ferrous fumarate ( 60 mg elemental Fe ) daily or intermittently ( three times a week ) , respectively ; and GC was the control group , without supplementation . The follow up was carried out until 34 - 37 weeks of gestational age ( Tf ) , but only 43 % of pregnant women completed the trial . At To and Tf fasting blood sample s were collected and Hematocrit ( Hct ) , Hemoglobin ( Hb ) , Erythrocyte Protoporphyrin ( EP ) and Serum Ferritin ( FERR ) were determined . The percentage of women with abnormal biochemical values at To ( n = 203 ) was : Hb ( g/dl ) 70 : 4.8 % ; FERR ( ng/ml ) Hct ( % ) : GC : 37.7 + /- 3.4 and 36.0 + /- 3.2 ( p Hb ( g/dl ) : GC : 12.5 + /- 1.2 and 11.9 + /- 1.3 ( p Hb decrease ; b ) Fe stores decreased during pregnancy regardless of Fe supplementation and frequency ; c ) EP values indicate that intermittent Fe administration was more efficient to maintain normal erythropoiesis",
"The known increased need for iron during pregnancy appears to be met only in part by increased iron absorption and amenorrhea . Considerable dem and s are made on maternal iron stores and , since many women lack sufficient storage iron , pregnancy may be expected to cause iron deficiency . This may lead to anemia in pregnancy and post partum and could also have a bearing on the iron status of the fetus and the neonate . Based on these considerations , prophylactic supplementation of dietary iron is advocated but remains a disputed issue . In the present controlled , prospect i ve and longitudinal study changes in hematologic status , and in particular in iron stores , during pregnancy were investigated in 44 healthy Caucasian women with uncomplicated pregnancies and deliveries . They were r and omly assigned to a study group ( n = 21 ) receiving oral iron supplements from the 16th week of amenorrhea until 6 weeks post partum , and a control group ( n = 23 ) without iron supplementation . Maternal concentrations of hemoglobin , serum iron , serum transferrin and serum ferritin were determined at 16 , 28 and 36 weeks of amenorrhea , at delivery , and 6 and 12 weeks post partum . The same variables were determined in cord blood . Iron supplementation appeared to prevent the physiologic fall in hemoglobin and serum iron concentrations which occurred in the control group , but had little influence on the observed rise in transferrin concentrations . Ferritin levels in serum , which are known to reflect mobilisable iron stores , fell to 30 % of the initial values in the control group and to 70 % in the study group . Six and 12 weeks post partum ferritin levels were still low in the nonsupplemented group ( Tab . I ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Background . The purpose of the present study was to evaluate the efficacy of low dose iron supplementation with and without a heme component , prescribed for women in the second half of pregnancy",
"OBJECTIVE To study the efficacy of iron supplementation during pregnancy and its influences on the outcome of pregnancy . METHODS A total of 369 pregnant women were enrolled in this study . According to the hemoglbin levels at recruitment , there were 2 groups : preventive ( Hb > or = 110 g/L ) and treatment ( Hb women entered the study from 20 - 24 gestational weeks and were r and omly assigned to materna treatment ( n = 96 ) who took materna 1 tablet daily or control group ( n = 95 ) who took no other supplementation . In the treatment groups , women less than 36 gestational weeks were accepted . They were r and omly divided as materna ( n = 93 ) 1 tablet/d , ferrous sulfate 0.3 g tid/d ( n = 50 ) or Ferroids 1 tablet/d ( n = 35 ) groups . Both Hb and serum ferritin concentrations were determined at admission and immediately after delivery . In some cases serum ferritin in the umbilical vein were measured as well . Hemoglobin levels were examined every 4 weeks during the observational period . RESULTS In the preventive groups , maternal serum ferritin levels after materna treatment were significantly higher than that before treatment and the control group ( P anemia women , compared the serum ferritin concentration , materna treatment had significantly higher levels than that at admission ( P ferrous sulfate or ferroids tratment groups ( P s-ferritin in the umbilical vein had no correlation with the paired maternal levels . There were no significant differences in the pregnancy outcomes among all the groups . CONCLUSION Materna can increase the iron storage and effectively improve the iron deficiency during pregnancy , and has no impact on the prgnancy outcomes",
"Side-effects of iron supplementation lead to poor compliance . A weekly-dose schedule of iron supplementation rather than a daily-dose regimen has been suggested to produce fewer side-effects , thereby achieving a higher compliance . This study compared side-effects of iron supplementation and their impact on compliance among pregnant women in Bangladesh . These women were assigned to receive either weekly doses of 2 x 60 mg iron ( one tablet each Friday morning and evening ) or a daily dose of 1 x 60 mg iron . Fifty antenatal care centres were r and omly assigned to prescribe either a weekly- or a daily-supplementation regimen ( 86 women in each group ) . Side-effects were assessed by recall after one month of supplementation and used for predicting compliance in the second and third months of supplementation . Compliance was monitored using a pill bottle equipped with an electronic counting device that recorded date and time whenever the pill bottle was opened . Of five gastrointestinal side-effects ( heartburn , nausea , vomiting , diarrhoea , or constipation ) assessed , vomiting occurred more frequently in the weekly group ( 21 % ) than in the daily group ( 11 % , p Compliance ( ratio between observed and recommended tablet intake ) was significantly higher in the weekly-supplementation regimen ( 93 % ) than in the daily-supplementation regimen ( 61 % , p gastrointestinal side-effects were not significantly associated with compliance . However , the presence of nausea and /or vomiting reduced compliance in both the regimens-but only among women from the lower socioeconomic group . In conclusion , weekly supplementation of iron in pregnancy had a higher compliance compared to daily supplementation of iron despite a higher frequency of side-effects . The findings support the view that gastrointestinal side-effects generally have a limited influence on compliance , at least in the dose ranges studied . Efforts to further reduce side-effects of iron supplementation may not be a successful strategy for improving compliance and effectiveness of antenatal iron supplementation",
"AIM To compare the hematological parameters and pregnancy outcome in women receiving daily versus weekly iron supplements during pregnancy . METHODS A prospect i ve r and omized controlled study was carried out at the Department of Obstetrics and Gynaecology of the All India Institute of Medical Sciences , New Delhi , India , during which 111 women were r and omized to receive either 100 mg elemental iron daily ( n=55 ) or 200 mg elemental iron weekly ( n=56 ) . Hemogram and serum ferritin level estimation were carried out at the beginning of pregnancy and within the 32 - 34-week period of gestation . Side-effects , compliance and the number of tablets consumed were noted for each group . The mean birth weight , period of gestation at delivery and mode of delivery were also compared between the two intervention groups . RESULTS There was no significant difference in the mean hemoglobin levels between the two intervention groups at the end of an average 17 weeks of iron supplementation . However , among anemic women who received daily supplementation , there was a greater rise in hemoglobin compared with those receiving supplementation weekly . The serum ferritin level was lower in the weekly supplemented group compared with that in the daily . There was no difference in the mean birth weight , period of gestation and mode of delivery between the two groups . Side-effects and non-compliance were significantly higher ( P iron supplementation is an effective option for prophylaxis in non-anemic pregnant women , but has less than optimal benefit in anemic women",
"A W.H.O. sponsored collaborative study of the effects of iron supplementation to pregnant women was carried out in Delhi ( northern India ) and Vellore ( southern India ) . Supplementation was given under supervision from the 26th to the 36th or 38th week of pregnancy . A control group received only placebo ; one group received vitamin B12 and folic acid alone ; four groups received vitamin B12 , folate and a daily iron supplement ranging from 30 to 240 mg of elemental iron as ferrous fumerate , and one further group received 120 mg of iron without B12 or folate . Groups receiving no iron showed a fall in mean stet concentration . Those receiving iron showed a rise in haemoglobin , the best results being in the groups receiving 120 and 240 mg of iron together with vitamin B12 and folate . Even in these groups however there was still a high prevalence of anaemia and iron deficiency at the end of the trial period . Iron alone did not produce as good results as iron plus vitamin B12 and folate . The supplementation had no detectable effect on the birth weight of the children , nor on the haemoglobin concentration of the infants at three months of age . The daily absorption of iron in the pregnant women , as judged from the increase in haemoglobin mass , was not as satisfactory as expected . Possible reasons for this are discussed . It is concluded that to provide these women with adequate iron a daily oral supplementation of 120 mg of elemental iron or more is needed . This can only be achieved by medicinal means . Before supplementation can be recommended on a public health scale , further information regarding the cost and expected benefits of such measures must be obtained",
"OBJECTIVE Our purpose was to study the effect of hematinic supplementation on the maternal erythropoietin response during singleton pregnancy . STUDY DESIGN In a r and omized , double-blind trial 97 patients with a first-trimester hemoglobin level > or = 14.0 gm/dl received either iron and folic acid ( hematinic group , n = 53 ) or a placebo ( n = 44 ) . Serial hemoglobin , hematocrit , and serum erythropoietin were recorded from maternal blood and from cord blood on delivery . Serum ferritin was measured in the first trimester , at 36 weeks ' gestation , and in cord blood . RESULTS In both groups ( 1 ) the mean hemoglobin was lower ( p mean serum erythropoietin was higher ( p mean serum ferritin was lower ( p mean hemoglobin and hematocrit were similar in the two groups until the third trimester but thereafter were higher ( p mean maternal serum erythropoietin was higher ( p mean cord blood hematologic values were similar in the two groups . CONCLUSION Maternal serum erythropoietin increased during pregnancy , but this response was reduced in the third trimester in the hematinic-supplemented group",
"OBJECTIVE To assess and compare the efficacy and safety of two and three doses of intravenous iron sucrose with daily oral ferrous sulphate in the prophylaxis of iron deficiency anaemia in pregnant women . STUDY DESIGN 260 women with singleton pregnancy who met inclusion criteria and who gave informed consent were r and omised between the 21st and 24th week into either the intravenous iron group or the oral iron group . Of 130 women in the intravenous iron group , 75 women received two doses of 200 mg iron sucrose and 55 three doses of 200 mg iron sucrose . The first dose was administered between the 21st and 24th gestational weeks , the second between the 28th and 32nd and the third between the 35th and 37th . The women of the oral group were given oral tablets of 80 mg ferrous sulphate daily , beginning on the day of study enrolment and stopping on the day of delivery . RESULTS There was a non-significant trend to a higher frequency of responders ( haemoglobin > or = 11 g/dl ) in the intravenous iron group ( 75 vs. 80 % ) . There was a significant difference of repleted iron stores before delivery ( ferritin>50 microg/l ) in the group with three intravenous iron doses in comparison to the oral iron group ( 49 vs. 14 % ; p maternal and perinatal outcomes . CONCLUSIONS There was no clinical ly significant difference in the haematological , maternal and foetal outcomes in the parenteral route of iron prophylaxis in pregnant women",
"A r and omized polycentric study was programmed to establish the effects of daily administration of ferritin iron from early pregnancy to puerperium . 254 women with normal iron balance at the beginning of their pregnancy were r and omized receiving no supplements or 40 mg iron daily . At the end of pregnancy iron balance was still normal only in one third of the pregnant women of the first group versus two third of the second group . 204 women who were iron-deficient received daily 40 or 120 mg of iron ; in this group anemia developed less frequently ( 13 % versus 29 % ) and iron balance normalized in one subject on four ; the great majority of these women remained iron-deficient . Unwanted effects of minimal or mild relevance , and almost always sporadic were observed in 6.5 % of cases and with the reduction or withdraw of the treatment in only 1.4 % of cases . These results showed that daily administration of ferritin iron during pregnancy is effective and well tolerated ; furthermore they suggest that the treatment must be done with at least 60 mg daily in women with normal iron balance and protracted also after the puerperium in iron deficient subjects",
"BACKGROUND Iron deficiency is most commonly found in women of reproductive age and infants worldwide , but the influence of maternal iron deficiency on infant development is underexplored . OBJECTIVE The objective was to examine the relation between maternal iron status and mother-child interactions in a r and omized , double-blind , intervention trial conducted in South Africa . DESIGN Women were recruited into the study from a health clinic at 6 - 8 wk postpartum and were classified as either iron-deficient anemic ( IDA ) or iron-sufficient after blood analysis . IDA mothers received iron supplements of 125 mg FeSO(4 ) ( IDA-Fe ; n = 34 ) or placebo ( IDA-PL ; n = 30 ) daily from 10 wk to 9 mo postpartum . The control group ( n = 31 ) consisted of iron-sufficient mothers . Free-play mother-child interaction sessions were videotaped in the clinic at 10 wk ( n = 80 ) and 9 mo ( n = 66 ) postpartum and coded per the Emotional Availability Scales ( 4 maternal scales : sensitivity , structuring , nonintrusiveness , and nonhostility ; 2 infant scales : responsiveness and involvement ) . RESULTS At 10 wk , scores for maternal sensitivity and child responsiveness were significantly greater in the control group than in the IDA groups ( P = 0.028 and 0.009 , respectively ) . At 9 mo , the control and IDA-Fe groups no longer differed . These 2 groups scored significantly better on the maternal sensitivity , structuring , and nonhostility scales and on the child responsiveness scale than did the IDA-PL group ( P = 0.007 - 0.032 ) , whose iron status remained low . CONCLUSION These data indicate that maternal iron deficiency negatively affects mother-child interactions and that iron supplementation protects against these negative effects",
"OBJECTIVE The hypothesis that daily use of a prenatal supplement with iron from enrollment to third trimester to initially iron-replete , nonanemic pregnant women would reduce third-trimester anemia and improve birth outcomes was tested . STUDY DESIGN Eight hundred sixty-seven women in Raleigh , North Carolina , who were at or = 110 g/L and ferritin levels of > or = 40 microg/L and were assigned r and omly to receive prenatal supplements with 30 mg of iron as ferrous sulfate ( n = 218 women ) or 0 mg of iron ( n = 211 women ) until 26 to 29 weeks of gestation . Intent-to-treat analysis was used for the outcomes of third-trimester iron status , birth weight , preterm birth , and small-for-gestational age . RESULTS Mean birth weight was higher by 108 g ( P = .03 ) , and the incidence of preterm delivery was lower ( 8 % vs 14 % ; P = .05 ) in the 30-mg group compared with the control group , respectively . Iron supplementation did not affect the prevalence of small-for-gestational age infants or third-trimester iron status . CONCLUSION Prophylactic iron supplementation that is begun early in pregnancy among low income women in the United States may have benefits beyond the reduction of iron deficiency anemia during pregnancy",
"This trial compares routine and selective iron supplementation during pregnancy to determine whether routine supplementation adversely affects fetal growth , increases infections and subjective adverse effects , and /or delays birth . At their first prenatal visit , 2912 pregnant women were r and omized into two groups ( 2694 gave birth ) . Compliance was satisfactory as measured by self-reports by mothers and hematocrit values in the third trimester . More women in the routinely supplemented group had subjected adverse effects . The groups were similar in regard to most of the other outcomes . In the selectively supplemented group , there was weak evidence for increase in sick-days , referrals to hospital outpatient clinic , cesarean section , blood transfusions , and infants who were diagnosed as having hyperviscosity . In the routine group , there were somewhat more women with gestations greater than or equal to 41 weeks and more dead infants . The subgroup analyses suggest that some of the apparently worse outcomes in the selective group were due to reactions of midwives and physicians to low hematocrit values",
"The effect of iron supplementation , 66 mg elemental iron daily , from the 16th week of gestation to delivery , on iron status markers during uncomplicated pregnancies was assessed in a r and omised , double-blind , placebo controlled study of 207 healthy women ( 100 iron treated , 107 placebo treated ) and their newborn babies . Haemoglobin ( Hb ) and serum ( S- ) human placental lactogen ( HPL ) were measured in all 207 females , while transferrin saturation , S-ferritin and S-erythropoietin ( EPO ) were measured in 120 females at monthly intervals . Hb : from 27th week of gestation to eight weeks post partum , the placebo treated group had significantly lower Hb levels than the iron treated group ( p less than 0.001 ) . Iron status markers : in the placebo group ( n = 57 ) , 92 % developed exhausted iron stores ( i.e. S-ferritin less than or equal to 20 micrograms/l ) , 65 % latent iron deficiency ( i.e. S-ferritin less than or equal to 20 micrograms/l and transferrin saturation less than 15 % ) , and 18 % iron deficiency anaemia ( i.e. S-ferritin less than or equal to 20 micrograms/l , transferrin saturation less than 15 % and Hb less than 110 g/l ) . In the iron treated group ( n = 63 ) , 54 % developed exhausted iron stores , 6 % latent iron deficiency , and none iron deficiency anaemia . S-EPO : the placebo group had significantly higher values than the iron treated group from the 27th week of gestation to one week post partum ( p less than 0.01 ) . S-HPL : levels were identical in placebo and iron treated females . Babies of iron treated mothers had higher S-ferritin than babies of placebo treated mothers ( p less than 0.02 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"A r and omized , double-blind , placebo-controlled community-based trial of oral iron supplementation ( 200 mg ferrous sulphate daily ) administered to multigravid pregnant women by traditional birth attendants ( TBAs ) was carried out in a rural area of The Gambia . Iron supplementation led to a significant reduction in the prevalence of anaemia and of iron deficiency . Iron supplementation was not accompanied by increased susceptibility to malaria infection ; there was no difference in the prevalence and severity of peripheral blood or placental malaria infection between the 2 groups of women . The birth weight of children born to women who received iron prophylaxis was increased by an average of 56 g. It is concluded that oral iron prophylaxis can be successfully delivered through TBAs integrated into a primary health care programme . This simple intervention can produce significant beneficial effects on the health of the mother without inducing increased susceptibility to malaria and has the potential for reducing perinatal mortality by increasing birth weight",
"BACKGROUND Community iron supplementation programmes for pregnant women have lacked effectiveness , partly because of low compliance . OBJECTIVE To determine factors that influence compliance among pregnant women in Senegal . DESIGN Two hundred and twenty-one pregnant women , recruited from six health centres in Dakar during their first prenatal visit , were r and omly assigned to receive either a prescription to purchase iron/folic acid tablets ( control , n = 112 ) to be taken daily , according to official policy , or to receive free tablets ( treatment , n = 109 ) . Compliance was assessed 20 weeks after enrollment through interviews and pill count . Women with low or high compliance ( % or > or=70 % ) were asked to explain what influenced their adherence to supplementation . RESULTS Overall compliance was 69 % ; it was significantly higher in the treatment than in the control group ( 86 % vs. 48 % ; P improved health upon taking the tablets ( treatment = 24 % , control = 10 % ) ; ( 2 ) the insistence by midwives that they take the tablets ; and ( 3 ) the mention that the tablets would improve health . Women with low compliance ( 42 % ) reported : ( 1 ) the experience of side-effects that they associated with the tablets ( treatment = 13 % , control = 14 % ) ; ( 2 ) misunderst and ing that they needed to continue taking the tablets throughout pregnancy ( treatment = 0 % , control = 18 % ) ; and ( 3 ) forgetfulness . CONCLUSION Compliance with iron/folic acid supplementation in Senegal can be increased by providing women with clear instructions about tablet intake and educating them on the health benefits of the tablets",
"It is evident that intermittent iron supplementation is better than daily supplementation in two aspects : iron absorption is more efficient and has insignificant side effects in contrast to the daily dose . The significantly higher daily iron loss observed in the daily iron supplemented groups rats also suggests alterations in total body iron metabolism . Based on serum ferritin distribution patterns , intermittent iron supplementation avoids temporary iron overload with daily iron supplemented . We conclude that weekly iron supplementation scheme is safer and easier to administer . This feasible strategy for the control of iron deficient anemia in pregnant women and children would be an effective iron-supplementation program ( Baily et al. , 1993 )",
"This study was planned to determine whether iron deficiency in pregnancy predisposed to the development of folate deficiency and also the smallest daily iron supplement that maintained haemoglobin levels in pregnancy . Three groups of women were given oral ferrous fumarate supplying 30 , 60 , and 120 mg of iron ; a fourth group was given 1 g of parenteral iron in early pregnancy followed by oral iron ( 60 mg ) ; a fifth group received a placebo . Tablets were taken once daily . Oral iron 30 mg once daily maintained haemoglobin levels throughout pregnancy . Women whose marrows lacked demonstrable iron at the 37th week had a significantly higher incidence of megaloblastic haemopoiesis ( 28·7 % ) than those with demonstrable iron stores ( 15·3 % ) ; women taking oral iron did not have a lower frequency of megaloblastosis than those given a placebo . We concluded that iron does not have a direct effect on folate status in pregnancy , that the association of iron deficiency and megaloblastic anaemia in pregnancy is the result of poor nutrition , and that there is no cause- and -effect relation between them",
"An iron supplementation trial versus placebo was performed in double blind on 191 attending at 3 month the antenatal clinic of Poissy maternity . Iron status of mothers and newborns was assessed at 3 , 5 , 7 month , during the delivery and 2 months after the delivery , using biochemical indicators ( hemoglobin level , serum ferritin ) . The compliance was good in 165 pregnant women ( 86 % of the initial sample ): 81 in the iron group , 84 in the placebo group . Among the placebo group , anemia ( Hb less than 11 g/dl ) was observed at the end of the pregnancy in 30 % of women . Depletion of iron stores started at 5 month . In the iron group , hemoglobin level increased significantly during the pregnancy and anemia was observed only in 3 % of women at the delivery . Iron status of newborns and two months after delivery was related to mothers iron status at delivery and particularly at the 7th month of pregnancy",
"OBJECTIVE To compare the effectivity of weekly versus daily iron therapy in reducing maternal anemia and to evaluate the association of maternal hemoglobin and fetal growth . DESIGN Prospect i ve . SETTING Tertiary care teaching hospital in an urban metropolis . METHOD 40 pregnant women received daily and 40 pregnant women received weekly oral therapy ( 335 mg of ferrous sulphate and 500 g folic acid ) for a period of 14 weeks . The age of each pregnant woman and their baseline anthropometric data ( weight , height and body mass index ) were estimated . Hemoglobin and hematocrit estimations were carried out during follow period at 4 wks , 8 wks and 14 weeks . Serum ferritin values as a marker of iron status were also calculated in both the groups initially , at 14 weeks and at the time of delivery . Fetal anthropometric indices of 137 full term neonates delivered to mothers included in either of the supplementation groups or admitted to the hospital were also studied in relation to maternal hemoglobin concentration . RESULTS Forty subjects each were initially r and omized into groups I and II . The age of pregnant women along with their baseline anthropometric data were similar in both groups . A total of 29 pregnant women in group I and 27 pregnant women in group II could be regularly followed up . The increase in hemoglobin and hematocrit values were similar in daily and weekly supplemented mothers . An intention to treat analysis also showed similar results . The ferritin values were similar at the start of supplementation and after 14 wks of weekly or daily iron therapy . Birth weight , crown heel length , head circumference of the neonate and placental weight increased significantly with rise in maternal hemoglobin levels . CONCLUSION Weekly iron supplementation is an effective mode of treating anemia among pregnant women and maternal anemia during pregnancy is adversely associated with fetal growth",
"Objective . To determine the lowest dose of iron preventative of iron deficiency and iron deficiency anemia in pregnancy",
"BACKGROUND We undertook this study to compare the effectiveness and safety of antenatal daily and weekly supplementation with iron , folic acid , and vitamin B(12 ) in healthy , pregnant women who were not anemic at gestational week 20 . METHODS Women with singleton pregnancies and blood hemoglobin ( Hb ) > 115 g/L at gestational week 20 ( equivalent to 105 g/L at sea level ) were r and omly assigned to two groups , one consuming one tablet containing 60 mg iron , 200 mug folic acid and 1 mug vitamin B(12 ) daily ( DS , n = 56 ) ; the other consuming two tablets once weekly ( WS , n = 60 ) . Blood Hb and serum ferritin concentrations were measured every 4 weeks from weeks 20 to 36 , and pregnancy outcomes were evaluated . RESULTS Mild anemia and hypoferritinemia throughout pregnancy occurred less frequently in DS than WS . None of the 116 women had Hb concentrations hemoconcentration ( Hb > 145 g/L ) from gestational week 28 onwards occurred in 11 % in DS and 2 % in WS . We observed ex post facto that hemoconcentration at gestational week 28 was associated with a significantly higher relative risk of low birth weight ( RR 6.23 , 95 % CI 1.46 - 26.57 ) and premature delivery ( RR 7.78 , 95 % CI 1.45 - 24.74 ) . CONCLUSIONS In women who were nonanemic at gestational week 20 , both schemes ( DS and WS ) prevented the occurrence of Hb levels hemoconcentration . Hemoconcentration was associated with increased risk of low birth weight and premature delivery",
" A total of 418 pregnant women at 16 - 24 wk of gestation , from six subcentres of a rural block of Varanasi district were selected . Pregnant women ( 137 of 215 ) from 3 subcentres received the supplementation of 60 mg elemental iron as ferrous sulphate combined with 500 micrograms folic acid , daily for 100 days ( study group ) and 123 ( of 203 ) pregnant women from the other 3 subcentres without supplementation ( control group ) could be evaluated for their pregnancy outcome . The haemoglobin and serum ferritin levels increased significantly in the study group . In the latter , the mean birth weight was 2.88 + /- 0.41 kg with low birth weight incidence of 20.4 per cent as compared to the control figures of 2.59 + /- 0.34 kg and 37.9 per cent respectively . The incidence of low birth weight was further reduced to 12.1 per cent if the supplementation could be started by 16 - 19 wk of gestation",
"OBJECTIVE To study the effect of iron supplementation on pregnancy outcome in pregnant women with haemoglobin ( Hb ) > or = 13.2 g/dl . DESIGN A r and omised , double-blind , placebo-controlled trial . SETTING Routine health services . POPULATION Seven hundred and twenty-seven pregnant women with Hb > or = 13.2 g/dl in the early stage of the second trimester . METHODS Each woman took one ferrous sulphate [ DOSAGE ERROR CORRECTED ] tablet ( 150 g tablet , containing 50 mg of elemental iron ) [ DOSAGE ERROR CORRECTED ] daily in the case group ( n = 370 ) or placebo in the control group ( n = 357 ) throughout pregnancy . MAIN OUTCOME MEASURES Pregnancy outcome . RESULTS While there were no significant differences in demographic and obstetric characteristics between the two groups before any intervention , small-for-gestational-age birth rate and the number of women with hypertension disorder increased significantly in the case group in comparison with the control group ( 57 [ 15.7 % ] versus 36 [ 10.3 % ] , P = 0.035 , 10 [ 2.7 % ] versus 3 [ 8 % ] , P = 0.05 , respectively ) . CONCLUSIONS Our finding proves that routine iron supplementation in nonanaemic women is not rational and may be harmful",
"Hemoglobin ( Hb ) concentration , serum iron level , iron binding capacity and blood folate ( Lactobacillus casei ) activity were determined in 310 unselected pregnant Burmese women . Hb concentration was less than 11 g/dl in 72 % of the women ; the serum iron level was less than 50 mug/dl in 33 % ; serum folate activity was less than 3ng/ml in 13 % ; and red cell folate activity was less than 100 ng/ml in 17 % of the women . Ninety-six of the women in our study were r and omly divided into four groups , treated from the 22nd to the 25th week of pregnancy until full term with either ferrous sulfate containing 60 mg elemental iron twice daily , 5 mg folic acid twice daily , a combination of both , or a placebo only . At full term , Hb concentration fell in the groups given placebo or folic acid . On the other h and , in the groups given iron alone or iron plus folic acid there was an increase in Hb of 0.4 and 0.7 g/dl , respectively ( intergroup difference not statistically significant ) . Serum iron and blood folate levels fell in the groups not receiving the appropriate hematinic . In spite of deficient serum and red cell folate levels in 30 and 40 % , respectively , of the group on iron alone , the mean Hb concentration increased at full term and none of the women had a Hb concentration lower than 10 g/dl . Blood folate levels were lower in the iron-supplemented group than in the placebo group , indicating that iron deficiency does not aggravate the folate nutritional status",
"Iron ( Fe ) deficiency and anemia during pregnancy remain highly prevalent in Senegal because of low compliance with Fe supplementation . Improving women 's access to supplements may increase compliance . Six prenatal centers in Dakar were r and omly assigned to either a control group in which women received routine prenatal visits , including prescriptions to purchase iron/folic acid tablets ( IFA ) according to the guidelines of the current Senegalese supplementation program ( n=112 ) , or to an intervention group in which women received free IFA ( n=109 ) in addition to routine prenatal care . Compliance was assessed 20 weeks after enrollment by pill count and interviews . Hemoglobin , erythrocyte protoporphyrin and serum ferritin were measured at baseline and follow-up . Compliance was 48 % and 86 % in the control and intervention groups , respectively ( P prevalence of anemia was 62 % in the control group versus 31 % in the intervention group ( P prevalence of Fe deficiency was 49 % and 21 % in the control and intervention groups , respectively ( P IFA for pregnant women visiting health centers could dramatically increase their compliance , improve Fe status and decrease the incidence of anemia"
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This systematic review up date s the current state of evidence on the effectiveness of softer flooring and cushioned shoe insoles on reducing musculoskeletal discomfort amongst workers who are required to st and for prolonged periods to work and the impact of factors such as age and gender on the outcomes . A systematic search identified 10 unique studies that met the eligibility criteria . The heterogeneity of study design s impacted on the strength of evidence . A moderate level of evidence was found in support of using cushioned material s in reducing discomfort/fatigue among st and ing workers . A limited level of evidence exists in favour of using insoles over anti-fatigue mats . Insufficient information exists for the impact of gender or age . Larger , good quality prospect i ve intervention trials based in real workplaces that consider the impact of psychosocial and organisational factors on musculoskeletal discomfort whilst st and ing at work are required to inform industry recommendations
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"Background It is possible that cross-over studies included in current systematic review s are being inadequately assessed , because the current risk of bias tools do not consider possible biases specific to cross-over design . We performed this study to evaluate whether this was being done in cross-over studies included in Cochrane Systematic Review s ( CSRs ) . Methods We search ed the Cochrane Library ( up to 2013 issue 5 ) for CSRs that included at least one cross-over trial . Two authors independently undertook the study selection and data extraction . A r and om sample of the CSRs was selected and we evaluated whether the cross-over trials in these CSRs were assessed according to criteria suggested by the Cochrane h and book . In addition we reassessed the risk of bias of these cross-over trials by a checklist developed form the Cochrane h and book . Results We identified 688 CSRs that included one or more cross-over studies . We chose a r and om sample of 60 CSRs and these included 139 cross-over studies . None of these CSRs undertook a risk of bias assessment specific for cross-over studies . In fact items specific for cross-over studies were seldom considered anywhere in quality assessment of these CSRs . When we reassessed the risk of bias , including the 3 items specific to cross-over trials , of these 139 studies , a low risk of bias was judged for appropriate cross-over design in 110(79 % ) , carry-over effects in 48(34 % ) and for reporting data in all stages of the trial in 114(82 % ) . Assessment of biases in cross-over trials could affect the GRADE assessment of a review ’s findings . Conclusion The current Cochrane risk of bias tool is not adequate to assess cross-over studies . Items specific to cross-over trials leading to potential risk of bias are generally neglected in CSRs . A proposed check list for the evaluation of cross-over trials is provided",
"Background Footwear interventions are often prescribed to assist with the management of lower limb pain , injury and disease . Commercially available shoe insoles and orthoses are increasingly incorporating novel design features to alleviate foot and lower limb symptoms , but this may be at a cost to optimal functional performance . This study compared the immediate effects of wearing glycerine-filled insoles , contoured prefabricated orthoses , and flat insoles , on balance and gait measures . Methods Thirty healthy adults ( 17 men , 13 women ; mean [ SD ] age : 24.3 [ 2.5 ] years ) performed tests of single-leg st and ing with eyes open ( Kistler force platform ) , star excursion balance test , and level-ground walking ( GAITRite ® walkway system ) , under three r and omised conditions : wearing glycerine-filled insoles , prefabricated orthoses , and flat ( control ) insoles , within their own footwear . Centre of pressure movement ( anterior-posterior and mediolateral range and st and ard deviation , total path velocity ) , star excursion balance test reach distance , and temporospatial gait variables were collected . Perceived comfort of the inserts was scored immediately after use on a 100 mm visual analogue rating scale . After trialling all inserts each participant ranked their level of comfort from least to most . Results Centre of pressure measures , star excursion balance test reach distance , or temporospatial gait variables did not differ between the three inserts ( all P values > 0.088 ) . Significant between-condition differences were reported for comfort ranking ( P = 0.031 ) , but not rating scores ( P = 0.638 ) . Weak to moderate negative correlations ( r values ranged between −0.368 and −0.406 ) were observed between visual analogue scale comfort rating for the flat insoles and prefabricated orthoses , star excursion balance test and gait measures . Conclusions Single-leg st and ing balance , star excursion balance test performance , and level-ground walking patterns in asymptomatic adults do not appear to differ when wearing glycerine-filled insoles , contoured prefabricated orthoses , or flat insoles . Perceived comfort may be related to the biomechanical or clinical effectiveness of novel footwear interventions , and requires further investigation . Importantly , these findings are specific to a healthy population and further research is needed to determine the long-term effects of glycerine-filled insoles in patients with known balance impairments"
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41173b42-06ff-11f0-808a-c43d1ab1c353
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Purpose The objective of this systematic review was to synthesize evidence on the effectiveness of workplace-based return-to-work ( RTW ) interventions and work disability management ( DM ) interventions that assist workers with musculoskeletal ( MSK ) and pain-related conditions and mental health ( MH ) conditions with RTW . Methods We followed a systematic review process developed by the Institute for Work & Health and an adapted best evidence synthesis that ranked evidence as strong , moderate , limited , or insufficient . Results Seven electronic data bases were search ed from January 1990 until April 2015 , yielding 8898 non-duplicate references . Evidence from 36 medium and high quality studies were synthesized on 12 different intervention categories across three broad domains : health-focused , service coordination , and work modification interventions . There was strong evidence that duration away from work from both MSK or pain-related conditions and MH conditions were significantly reduced by multi-domain interventions encompassing at least two of the three domains . There was moderate evidence that these multi-domain interventions had a positive impact on cost outcomes . There was strong evidence that cognitive behavioural therapy interventions that do not also include workplace modifications or service coordination components are not effective in helping workers with MH conditions in RTW . Evidence for the effectiveness of other single-domain interventions was mixed , with some studies reporting positive effects and others reporting no effects on lost time and work functioning . Conclusions While there is substantial research literature focused on RTW , there are only a small number of quality workplace-based RTW intervention studies that involve workers with MSK or pain-related conditions and MH conditions . We recommend implementing multi-domain interventions ( i.e. with healthcare provision , service coordination , and work accommodation components ) to help reduce lost time for MSK or pain-related conditions and MH conditions . Practitioners should also consider implementing these programs to help improve work functioning and reduce costs associated with work disability
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"This study evaluated a two-year multidisciplinary early intervention pilot programme for back-injured nurses employed at a large teaching hospital , using a pre- versus post-programme analysis . The purpose was to ascertain whether this programme could reduce the incidence , morbidity , time lost and cost due to back injuries in the 250 nurses employed on ten targeted high-risk wards . Injuries in the remaining 1395 nurses employed on the other 45 wards were monitored concurrently for comparison . The programme consisted of prompt assessment , treatment and rehabilitation through modified work . Evaluative data were gathered by one research nurse on st and ardized forms at the time of injury , weekly until return to work , and at a six-month follow-up . Time lost and cost data for up to one-year post-injury were derived from workers ' compensation statements . Compared to the two years prior to introduction of the programme , the rates of back injuries and lost-time back injuries decreased by 23 % and 43 % , respectively , on the targeted wards , while these increased on the control wards . Combined expenditure was 32 % lower per injury and 34 % lower per lost-time injury for those in the targeted group who consented to take part in the programme compared to their counterparts on the control wards , as the increased assessment and treatment costs per case attributable to the programme were more than offset by the savings in lower compensation ( wage loss ) costs . This programme thus reduced the incidence and time lost due to back injuries and was cost-beneficial ",
"Background Major depressive disorder is among the medical conditions with the highest negative impact on work outcome . However , little is known regarding evidence -based interventions targeting the improvement of work outcomes in depressed employees . In this paper , the design of a r and omized controlled trial is presented in order to evaluate the effectiveness of adjuvant occupational therapy in employees with depression . This occupational intervention is based on an earlier intervention , which was design ed and proven effective by our research group , and is the only intervention to date that specifically targets work outcome in depressed employees . Methods / Design In a two-arm r and omized controlled trial , a total of 117 participants are r and omized to either ' care as usual ' or ' care as usual ' with the addition of occupational therapy . Patients included in the study are employees who are absent from work due to depression for at least 25 % of their contract hours , and who have a possibility of returning to their own or a new job . The occupational intervention consists of six individual sessions , eight group sessions and a work-place visit over a 16-week period . By increasing exposure to the working environment , and by stimulating communication between employer and employee , the occupational intervention aims to enhance self-efficacy and the acquisition of more adaptive coping strategies . Assessment s take place at baseline , and at 6 , 12 , and 18-month follow-ups . Primary outcome measure is work participation ( hours of absenteeism and time until work resumption ) . Secondary outcome measures are work functioning , symptomatology , health-related quality of life , and neurocognitive functioning . In addition , cost-effectiveness is evaluated from a societal perspective . Finally , mechanisms of change ( intermediate outcomes ) and potential patient-treatment matching variables are investigated . Discussion This study hopes to provide valuable knowledge regarding an intervention to treat depression , one of the most common and debilitating diseases of our time . If our intervention is proven ( cost- ) effective , the personal , economic , and health benefits for both patients and employers are far-reaching . Trial registration",
"Background In the present study the effect of a workplace-oriented intervention for persons on long-term sick leave for clinical burnout , aim ed at facilitating return to work ( RTW ) by job-person match through patient-supervisor communication , was evaluated . We hypothesised that the intervention group would show a more successful RTW than a control group . Methods In a prospect i ve controlled study , subjects were identified by the regional social insurance office 2 - 6 months after the first day on sick leave . The intervention group ( n = 74 ) was compared to a control group who had declined participation , being matched by length of sick leave ( n = 74 ) . The RTW was followed up , using sick-listing register data , until 1.5 years after the time of intervention . Results There was a linear increase of RTW in the intervention group during the 1.5-year follow-up period , and 89 % of subjects had returned to work to some extent at the end of the follow-up period . The increase in RTW in the control group came to a halt after six months , and only 73 % had returned to work to some extent at the end of the 1.5-year follow-up . Conclusions We conclude that the present study demonstrated an improvement of long-term RTW after a workplace-oriented intervention for patients on long-term sick leave due to burnout . Trial registration Current Controlled Trials NCT01039168",
"BACKGROUND Occupational health guidelines recommend a biopsychosocial approach to manage sickness absence due to musculoskeletal disorders ( MSDs ) , with a primary focus on early intervention through provision of a supportive network . AIMS To investigate the implementation of a guidelines -based intervention ( early contact of absentees ; addressing psychosocial obstacles ; offering temporary modified work ; communicating among the players ) , and to determine whether this is effective for reducing return-to-work times and duration of future absence . METHODS A non-r and omized controlled trial was conducted within a UK company . Occupational health nurses at two experimental sites ( 1,435 workers ) were trained to deliver the intervention to workers taking absence due to MSDs ( low back and upper limb disorders ) , while usual care was delivered at three control sites ( 1,483 workers ) . Company-recorded absence data were collected over a 12-month follow-up period . RESULTS The implementation of the experimental intervention was impeded by unforeseen organizational obstacles at one site ( policies , procedures and individual approaches ) which had a detrimental effect on uptake and delivery . At the site where the intervention was delivered per protocol , absence was significantly less compared with controls ; 6.5 and 10.8 days , respectively . However , the duration of future absence was not significantly different ( 13.0 and 25.1 days , respectively ) . CONCLUSIONS An early intervention addressing psychosocial obstacles to recovery can be effective for reducing absence due to MSDs . Successful implementation , where the key players are onside and organizational obstacles are overcome , is difficult to achieve",
"Background Common mental disorders , such as depression , anxiety disorder , and adjustment disorder , have emerged as a major public and occupational health problem in many countries . These disorders can have severe consequences such as absenteeism and work disability . Different interventions have been developed to improve the return-to-work of employees with common mental disorders , but still a large proportion of employees experiences health and work problems after their return-to-work . For this reason , the SHARP-at work intervention is developed to prevent a relapse of sickness absence among employees who have returned to work after a period of sickness absence because of common mental disorders . We aim to evaluate the effectiveness , cost-benefit and process of the intervention compared to care as usual . Methods / Design The study is design ed as a cluster-r and omised controlled trial with r and omisation at the level of the occupational physician . Employees who have returned to work after a period of sickness absence because of a common mental disorder are included in the study . Employees in the intervention group will receive the SHARP-at work intervention . The intervention focusses on active guidance of employees by occupational physicians during the first weeks of work after sickness absence . Employees in the control group will receive care as usual . Outcomes will be assessed at baseline and at 3 , 6 , and 12 months follow-up . The primary outcome is cumulative recurrent sickness absence days . Secondary outcome measures are mental health , work functioning , and coping . Adherence to the protocol , communication between stakeholders , and satisfaction with the treatment are the process measures assessed in both study groups . Cost-benefit is calculated from a societal perspective . Finally , prognostic factors for a relapse of sickness absence are investigated . Discussion This study goes beyond return-to-work by focussing on the prevention of recurrent sickness absence . The study incorporates not only outcomes on sickness absence and mental health but also on health-related work functioning . The results of this study can contribute to a further development of practice guidelines and the promotion of sustainable work participation . Trial registration",
"R and omised controlled trial to evaluate the effectiveness of collaborative care in a Dutch occupational healthcare setting : 126 workers on sick leave with major depressive disorder were r and omised to usual care ( n = 61 ) or collaborative care ( n = 65 ) . After 3 months , collaborative care was more effective on the primary outcome measure of treatment response ( i.e. reduction in symptoms of ≥50 % ) on the Patient Health Question naire-9 ( PHQ-9 ) . However , the groups did not differ on the PHQ-9 as a continuous outcome measure . Implication s of these results are discussed",
"Background To describe the design of a population based r and omized controlled trial ( RCT ) , including a cost-effectiveness analysis , comparing participative ergonomics interventions between 2–8 weeks of sick leave and Grade d Activity after 8 weeks of sick leave with usual care , in occupational back pain management . Methods Design : An RCT and cost-effectiveness evaluation in employees sick-listed for a period of 2 to 6 weeks due to low back pain . Interventions used are 1 . Communication between general practitioner and occupational physician plus Participative Ergonomics protocol performed by an ergonomist . 2 . Grade d Activity based on cognitive behavioural principles by a physiotherapist . 3 . Usual care , provided by an occupational physician according to the Dutch guidelines for the occupational health management of workers with low back pain . The primary outcome measure is return to work . Secondary outcome measures are pain intensity , functional status and general improvement . Intermediate variables are kinesiophobia and pain coping . The cost-effectiveness analysis includes the direct and indirect costs due to low back pain . The outcome measures are assessed before r and omization ( after 2–6 weeks on sick leave ) and 12 weeks , 26 weeks and 52 weeks after first day of sick leave . Discussion The combination of these interventions has been subject of earlier research in Canada . The results of the current RCT will : 1 . crossvali date the Canadian findings in an different sociocultural environment ; 2 . add to the cost-effectiveness on treatment options for workers in the sub acute phase of low back pain . Results might lead to alterations of existing (inter)national guidelines",
"Background The importance of staying active instead of bed rest has been acknowledged in the management of musculoskeletal disorders ( MSDs ) . This emphasizes the potential benefits of adjusting work to fit the employee 's remaining work ability . Despite part-time sick leave being an official option in many countries , its effectiveness has not been studied yet . We have design ed a r and omized controlled study to assess the health effects of early part-time sick leave compared to conventional full-day sick leave . Our hypothesis is that if work time is temporarily reduced and work load adjusted at the early stages of disability , employees with MSDs will have less disability days and faster return to regular work duties than employees on a conventional sick leave . Methods / Design The study population will consist of 600 employees , who seek medical advice from an occupational physician due to musculoskeletal pain . The inclusion requires that they have not been on a sick leave for longer than 14 days prior to the visit . Based on the physician 's judgement , the severity of the symptoms must indicate a need for conventional sick leave , but the employee is considered to be able to work part-time without any additional risk . Half of the employees are r and omly allocated to part-time sick leave group and their work time is reduced by 40–60 % , whereas in the control group work load is totally eliminated with conventional sick leave . The main outcomes are the number of days from the initial visit to return to regular work activities , and the total number of sick leave days during 12 and 24 months of follow-up . The costs and benefits as well as the feasibility of early part-time sick leave will also be evaluated . Conclusion This is the first r and omised trial to our knowledge on the effectiveness of early part-time sick leave compared to conventional full-time sick leave in the management of MSDs . The data collection continues until 2011 , but preliminary results on the feasibility of part-time sick leave will be available already in 2008 . The increased knowledge will assist in better decision making process regarding the management of disability related to MSDs . Trial Registration International St and ard R and omised Controlled Trial Number Register , register number IS RCT",
"Objective To evaluate the effectiveness of an integrated care programme , combining a patient directed and a workplace directed intervention , for patients with chronic low back pain . Design Population based r and omised controlled trial . Setting Primary care ( 10 physiotherapy practice s , one occupational health service , one occupational therapy practice ) and secondary care ( five hospitals ) . Participants 134 adults aged 18 - 65 sick listed for at least 12 weeks owing to low back pain . Intervention Patients were r and omly assigned to usual care ( n=68 ) or integrated care ( n=66 ) . Integrated care consisted of a workplace intervention based on participatory ergonomics , involving a supervisor , and a grade d activity programme based on cognitive behavioural principles . Main outcome measures The primary outcome was the duration of time off work ( work disability ) due to low back pain until full sustainable return to work . Secondary outcome measures were intensity of pain and functional status . Results The median duration until sustainable return to work was 88 days in the integrated care group compared with 208 days in the usual care group ( P=0.003 ) . Integrated care was effective on return to work ( hazard ratio 1.9 , 95 % confidence interval 1.2 to 2.8 , P=0.004 ) . After 12 months , patients in the integrated care group improved significantly more on functional status compared with patients in the usual care group ( P=0.01 ) . Improvement of pain between the groups did not differ significantly . Conclusion The integrated care programme substantially reduced disability due to chronic low back pain in private and working life . Trial registration Current Controlled Trials IS RCT N28478651",
"Study Design . R and omized controlled trial . Objectives . To investigate the effectiveness and costs of a mini-intervention , provided in addition to the usual care , and the incremental effect of a work site visit for patients with subacute disabling low back pain . Summary of Background Data . There is lack of data on cost-effectiveness of brief interventions for patients with prolonged low back pain . Methods . A total of 164 patients with subacute low back pain were r and omized to a mini-intervention group ( A ) , a work site visit group ( B ) , or a usual care group ( C ) . Groups A ( n = 56 ) and B ( n = 51 ) underwent one assessment by a physician plus a physiotherapist . Group B received a work site visit in addition . Group C served as controls ( n = 57 ) and was treated in municipal primary health care . All patients received a leaflet on back pain . Pain , disability , specific and generic health-related quality of life , satisfaction with care , days on sick leave , and use and costs of health care consumption were measured at 3- , 6- , and 12-month follow-ups . Results . During follow-up , fewer subjects had daily pain in Groups A and B than in Group C ( Group A vs. Group C , P = 0.002 ; Group B vs. Group C , P = 0.030 ) . In Group A , pain was less bothersome ( Group A vs. Group C , P = 0.032 ) and interfered less with daily life ( Group A vs. Group C , P = 0.040 ) than among controls . Average days on sick leave were 19 in Group A , 28 in Group B , and 41 in Group C ( Group A vs. Group C , P = 0.019 ) . Treatment satisfaction was better in the intervention groups than among the controls , and costs were lowest in the mini-intervention group . Conclusions . Mini-intervention reduced daily back pain symptoms and sickness absence , improved adaptation to pain and patient satisfaction among patients with subacute low back pain , without increasing health care costs . A work site visit did not increase effectiveness",
"Background Major depressive disorder ( MDD ) has major consequences for both patients and society , particularly in terms of needlessly long sick leave and reduced functioning . Although evidence -based treatments for MDD are available , they show disappointing results when implemented in daily practice . A focus on work is also lacking in the treatment of depressive disorder as well as communication of general practitioners ( GPs ) and other health care professionals with occupational physicians ( OPs ) . The OP may play a more important role in the recovery of patients with MDD . Purpose of the present study is to tackle these obstacles by applying a collaborative care model , which has proven to be effective in the USA , with a focus on return to work ( RTW ) . From a societal perspective , the (cost)effectiveness of this collaborative care treatment , as a way of transmural care , will be evaluated in depressed patients on sick leave in the occupational health setting . Methods / Design A r and omised controlled trial in which the treatment of MDD in the occupational health setting will be evaluated in the Netherl and s. A transmural collaborative care model , including Problem Solving Treatment ( PST ) , a workplace intervention , antidepressant medication and manual guided self-help will be compared with care as usual ( CAU ) . 126 Patients with MDD on sick leave between 4 and 12 weeks will be included in the study . Care in the intervention group will be provided by a multidisciplinary team of a trained OP-care manager and a consultant psychiatrist . The treatment is separated from the sickness certification . Data will be collected by means of question naires at baseline and at 3 , 6 , 9 and 12 months after baseline . Primary outcome measure is reduction of depressive symptoms , secondary outcome measure is time to RTW , tertiary outcome measure is the cost effectiveness . Discussion The high burden of MDD and the high level of sickness absence among people with MDD contribute to the relevance of this study . The intervention is an innovative approach , with trained OPs in a new role as care managers in the treatment of MDD . If this intervention proves to be cost-effective , implementation will be very relevant for individual patients as well as for society . Trial registration IS RCT",
"Introduction : Behaviorally oriented grade d activity interventions have been suggested for sick-listed workers with low back pain on return to work , but have not been extensively evaluated . Methods : One hundred and thirty-four workers were r and omly assigned to either a grade d activity intervention ( n = 67 ) or usual care ( n = 67 ) and followed-up for 12 months . Results : The grade d activity group returned back to work faster with a median of 54 days compared to 67 days in the usual care group . The grade d activity intervention was more effective after approximately 50 days post-r and omization ( HRR = 1.9 , CI = 1.2–3.1 , p = 0.01 ) . Differences between the groups in number of recurrent episodes , total number of days of sick leave due to low back pain , and total number of days of sick leave due to all diagnoses , were in favor of the grade d activity group , although not statistically significant . No effects of the grade d activity intervention were found for functional status or pain . Conclusion : Grade d activity intervention is a valuable strategy to enhance short-term return to work outcomes",
"Study Design . Population ‐based r and omized clinical trial . Objectives . To develop and test a model of management of subacute back pain , to prevent prolonged disability . Summary of Background Data . The present management of back pain seems inadequate , and development of innovative models has been urged . Methods . A model for the treatment of subacute work‐related back pain has been developed and evaluated in a population ‐based r and omized clinical trial . Workers ( n = 130 ) from eligible workplaces in the Sherbrooke area ( N = 31 ) , who had been absent from work for more than 4 weeks for back pain , were r and omized , based on their workplace , in one of four treatment groups : usual care , clinical intervention , occupational intervention , and full intervention ( a combination of the last two ) . The duration of absence from regular work and from any work was evaluated using survival analysis . Functional status and pain were compared at study entry and after 1 year of follow‐up . Results . The full intervention group returned to regular work 2.41 times faster than the usual care intervention group ( 95 % confidence interval 1.19‐4.89 ; P = 0.01 ) . The specific effect of the occupational intervention accounted for the most important part of this result , with a rate ratio of return to regular work of 1.91 ( 95 % confidence interval = 1.18‐3.10 ; P demonstrated either a statistically significant reduction or a trend toward reduction in the three intervention groups , compared with the trend in the usual care intervention group . Conclusions . Close association of occupational intervention with clinical care is of primary importance in impeding progression toward chronicity of low back pain",
"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",
"Two years of prospect i ve data on 416 back injuries were gathered at a 1100-bed acute and tertiary care hospital to assist target prevention efforts . The rate of injury among 1645 nurses was found to be highest for those working on orthopaedic , medicine , neurology , spinal and surgery wards , indicating priorities for prevention . In fact , 51 % of the orthopaedic nurses sustained at least one back injury during the two-year period . Gender did not significantly affect the risk of back injury ; however , injuries were slightly more common in nurses with less seniority and younger nurses were found to be at significantly increased risk of back injury . Almost 63 % of the back injuries which occurred in nurses working 8 h shifts on the high-risk wards occurred during the first two hours of the shift . Lifting and transferring patients with assistance were the two most common mechanisms for back injury ( 22.6 % and 23.3 % , respectively ) . In total , injured nurses attributed 52.3 % of their injuries to inadequate training ; inadequate staffing was given as the primary reason for 13.8 % of the injuries . The results suggest that training in the indications for and use of mechanical devices for lifting/transferring patients requires intensification , and a ' warm-up ' period should also be considered in the face of injuries occurring early in the shift if work activities can not be evenly planned",
"Objectives Workers with common mental disorders ( CMDs ) frequently experience recurrent sickness absence but scientifically evaluated interventions to prevent recurrences are lacking . The objectives of this study are to evaluate the cost-effectiveness and cost-benefit of a problem solving intervention aim ed at preventing recurrent sickness absence in workers with CMDs compared to care as usual . Methods An economic evaluation was conducted alongside a cluster-r and omised controlled trial with 12 months follow-up . Treatment providers were r and omised to either a 2-day training in the SHARP-at work intervention , i.e. a problem solving intervention , or care as usual . Effect outcomes were the incidence of recurrent sickness absence and time to recurrent sickness absence . Self-reported health care utilisation was measured by question naires . A cost-effectiveness analysis ( CEA ) from the societal perspective and a cost-benefit analysis ( CBA ) from the employer ’s perspective were conducted . Results The CEA showed that the SHARP-at work intervention was more effective but also more expensive than care as usual . The CBA revealed that employer ’s occupational health care costs were significantly higher in the intervention group compared to care as usual . Overall , the SHARP-at work intervention showed no economic benefit compared to care as usual . Conclusions As implementation of the SHARP-at work intervention might require additional investments , health care policy makers need to decide if these investments are worthwhile considering the results that can be accomplished in reducing recurrent sickness absence",
"Purpose Major depression is associated with high levels of absence and reduced productivity . Therefore the costs to society are high . The aim of this study was to evaluate the cost-utility of collaborative care for major depressive disorder ( MDD ) compared to care as usual in an occupational healthcare setting . A societal perspective was taken . Methods In this r and omised controlled trial , 126 sick-listed workers with MDD were included ( 65 collaborative care , 61 care as usual ) . Baseline measurements and follow up measures ( 3 , 6 , 9 and 12 months ) were assessed by question naire . We applied the Trimbos/iMTA question naire for costs associated with psychiatric illness , the SF-HQL and the EQ-5D respectively measuring the health care utilization , production losses and general health related quality of life . Results The average annual healthcare costs in the collaborative care group were € 3,874 ( 95 % CI € 2,778–€5,718 ) compared to € 4,583 ( 95 % CI € 3,108–€6,794 ) in the care as usual group . The average quality of life years ( QALY ’s ) gained were lower in the collaborative care group , 0.05 QALY . The majority of the ICERS ( 69 % ) indicate that collaborative care is less costly but also less effective than care as usual . Including the productivity costs did not change this result . Conclusions The cost-utility analysis showed that collaborative care generated reduced costs and a reduction in effects compared to care as usual and was therefore not a cost-effective intervention",
"Objectives To evaluate the cost effectiveness , cost utility and cost benefit of a workplace intervention compared with usual care for sick-listed employees with distress . Methods An economic evaluation was conducted alongside a r and omised controlled trial . Employees with distress and who were sick-listed for 2–8 weeks were r and omised to a workplace intervention ( n=73 ) or to usual care ( n=72 ) . The workplace intervention is a stepwise process involving the sick-listed employee and their supervisor , aim ed at formulating a consensus-based plan for return to work ( RTW ) . The effect outcomes were lasting RTW and quality -adjusted life years ( QALYs ) . Healthcare utilisation was measured over 12 months . Cost effectiveness analyses ( CEA ) and cost utility analyses ( CUA ) were conducted from the societal perspective and cost benefit analyses ( CBA ) from the employer perspective . Bootstrapping techniques were used to estimate cost and effect differences , related CIs , and cost effectiveness and cost utility ratios . Cost effectiveness planes were presented and subgroup analyses were performed . Results CEA and CUA revealed no statistically significant differences in lasting RTW , QALYs or costs . The CBA indicated a statistically significant higher cost of occupational health services in the workplace intervention group . The workplace intervention was not cost effective according to the CEA , CUA and CBA . Conclusions Widespread implementation of the workplace intervention for sick-listed employees with distress is not recommended because there was no economic benefit compared with usual care . Future trials should confirm if the workplace intervention is cost effective for the subgroup employees who intended to return to work despite symptoms . This trial has been registered at the Dutch National Trial Register IS RCT N92307123",
"The objective of this study is to compare the costs and benefits of a grade d activity ( GA ) intervention to usual care ( UC ) for sick-listed workers with non-specific low back pain ( LBP ) . The study is a single-blind , r and omized controlled trial with 3-year follow-up . A total of 134 ( 126 men and 8 women ) predominantly blue-collar workers , sick-listed due to LBP were recruited and r and omly assigned to either GA ( N = 67 ; mean age 39 ± 9 years ) or to UC ( N = 67 ; mean age 37 ± 8 years ) . The main outcome measures were the costs of health care utilization during the first follow-up year and the costs of productivity loss during the second and the third follow-up year . At the end of the first follow-up year an average investment for the GA intervention of € 475 per worker , only € 83 more than health care utilization costs in UC group , yielded an average savings of at least € 999 ( 95 % CI : −1,073 ; 3,115 ) due to a reduction in productivity loss . The potential cumulative savings were an average of € 1,661 ( 95 % CI : −4,154 ; 6,913 ) per worker over a 3-year follow-up period . It may be concluded that the GA intervention for non-specific LBP is a cost-beneficial return-to-work intervention",
"The aim of this study was to compare the effectiveness of two individual-level psychotherapy interventions : ( a ) treatment as usual consisting of cognitive-behavioral therapy ( CBT ) and ( b ) work-focused CBT ( W-CBT ) that integrated work aspects early into the treatment . Both interventions were carried out by psychotherapists with employees on sick leave because of common mental disorders ( depression , anxiety , or adjustment disorder ) . In a quasi-experimental design , 12-month follow-up data of 168 employees were collected . The CBT group consisted of 79 clients , the W-CBT group of 89 . Outcome measures were duration until return to work ( RTW ) , mental health problems , and costs to the employer . We found significant effects on duration until RTW in favor of the W-CBT group : full RTW occurred 65 days earlier . Partial RTW occurred 12 days earlier . A significant decrease in mental health problems was equally present in both conditions . The average financial advantage for the employer of an employee in the W-CBT group was estimated at $ 5,275 U.S. dollars compared with the CBT group . These results show that through focusing more and earlier on work-related aspects and RTW , functional recovery in work can be substantially speeded up within a regular psychotherapeutic setting . This result was achieved without negative side effects on psychological complaints over the course of 1 year . Integrating work-related aspects into CBT is , therefore , a fruitful approach with benefits for employees and employers alike",
"Study Design . A retrospective and prospect i ve cohort . Objectives . To compare the effectiveness of occupational intervention , early intervention , and st and ard care in the management of Worker ’s Compensation injury cl aims . Summary of Background Data . The current management of occupational back pain and work-related upper extremity disorders with either st and ard care or early intervention appears to be ineffective . Methods . A retrospective cohort compared injury cl aim incidence , duration , and costs between one company with access to st and ard care and another similar company with access to early intervention . A prospect i ve cohort looked at the effect of one company changing from st and ard care to occupational management in comparison with the control group with early intervention . Survival analysis was used to attempt to explain differences in injury cl aim duration . Results . St and ard care result ed in lower injury cl aim incidence , duration , and costs than early intervention , whereas occupational management result ed in lower injury cl aim incidence , duration , and costs than st and ard care . The covariates of physical therapist involvement , chiropractor involvement , injury severity , and relationship between Worker ’s Compensation and the employer were associated with delayed time to cl aim closure in the company with access to early intervention with the most important covariate being physical therapist involvement ( hazard rate ratio 19.88 , 95 % confidence interval 7.95–39.77 ) . Only the covariate of injury severity was associated with delayed time to cl aim closure in the company with access to occupational management ( hazard rate ratio 1.67 , 95 % confidence interval 1.05–27.20 ) . Conclusions . It is recommended that an occupational management approach , in comparison with st and ard care or early intervention , be considered for management of occupational injuries",
"The aim of this study was to determine whether grade d activity restored occupational function in industrial blue-collar workers who were sick-listed for 8 weeks because of subacute , nonspecific , mechanical low back pain ( LBP ) . Patients with LBP , who had been examined by an orthopedic surgeon and a social worker , were r and omly assigned to either an activity group ( n = 51 ) or a control group ( n = 52 ) . Patients with defined orthopedic , medical , or psychiatric diagnoses were excluded before r and omization . The grade d activity program consisted of four parts : ( 1 ) measurements of functional capacity ; ( 2 ) a work-place visit ; ( 3 ) back school education ; and ( 4 ) an individual , submaximal , gradually increased exercise program , with an operant-conditioning behavioral approach , based on the results of the tests and the dem and s of the patient 's work . Records of the amount of sick leave taken over a 3-year period ( ie , the 1-year periods before , during , and after intervention ) were obtained from each patient 's Social Insurance Office . The patients in the activity group returned to work significantly earlier than did the patients in the control group . The median number of physical therapist appointments before return to work was 5 , and the average number of appointments was 10.7 ( SD = 12.3 ) . The average duration of sick leave attributable to LBP during the second follow-up year was 12.1 weeks ( SD = 18.4 ) in the activity group and 19.6 weeks ( SD = 20.7 ) in the control group . Four patients in the control group and 1 patient in the activity group received permanent disability pensions . The grade d activity program made the patients occupationally functional again , as measured by return to work and significantly reduced long-term sick leave",
"Aims : To test the long term cost-benefit and cost-effectiveness of the Sherbrooke model of management of subacute occupational back pain , combining an occupational and a clinical rehabilitation intervention . Methods : A r and omised trial design with four arms was used : st and ard care , occupational arm , clinical arm , and Sherbrooke model arm ( combined occupational and clinical interventions ) . From the Quebec WCB perspective , a cost-benefit ( amount of consequence of disease costs saved ) and cost-effectiveness analysis ( amount of dollars spent for each saved day on full benefits ) were calculated for each experimental arm of the study , compared to st and ard care . Results : At the mean follow up of 6.4 years , all experimental study arms showed a trend towards cost benefit and cost effectiveness . These results were owing to a small number of very costly cases . The largest number of days saved from benefits was in the Sherbrooke model arm . Conclusions : A fully integrated disability prevention model for occupational back pain appeared to be cost beneficial for the workers ’ compensation board and to save more days on benefits than usual care or partial interventions . A limited number of cases were responsible for most of the long term disability costs , in accordance with occupational back pain epidemiology . However , further studies with larger sample s will be necessary to confirm these results",
"BACKGROUND Major depression has far-reaching consequences for work functioning and absenteeism . In most cases depression is treated by medication and clinical management . The addition of occupational therapy ( OT ) might improve outcome . We determined the cost-effectiveness of the addition of OT to treatment as usual ( TAU ) . METHOD Sixty-two adults with major depression and a mean absenteeism of 242 days were r and omized to TAU ( out-patient psychiatric treatment ) or TAU+OT [ 6 months , including ( i ) diagnostic phase with occupational history and work reintegration plan , and ( ii ) therapeutic phase with individual sessions and group sessions ] . Main outcome domains were depression , work resumption , work stress and costs . Assessment s were at baseline and at 3 , 6 , 12 and 42 months . RESULTS The addition of OT to TAU : ( i ) did not improve depression outcome , ( ii ) result ed in a reduction in work-loss days during the first 18 months , ( iii ) did not increase work stress , and ( iv ) had a 75.5 % probability of being more cost-effective than TAU alone . CONCLUSION Addition of OT to good clinical practice does not improve depression outcome , improves productivity without increasing work stress and is superior to TAU in terms of cost-effectiveness",
"Context Low back pain causes frequent disability and lost productive time . Contribution This r and omized trial compared a behavioral-oriented grade d activity program with usual care in 134 Dutch airline company workers who had missed work because of persistent low back pain . Grade d activity consisted of biweekly 1-hour exercise sessions with physiotherapists who emphasized operant-conditioning principles . Over 6 months of follow-up , participants in the grade d activity program missed 58 days of work , while participants receiving usual care missed 87 days . Implication s A behavioral-oriented grade d activity program returned participants with low back pain to work more often than did usual care . The Editors Nonspecific low back pain is an uncomfortable medical condition that causes frequent disability and absence from work . Most episodes of low back pain resolve fairly quickly and cause only short periods of absence from work . However , some workers with low back pain miss work for several days to weeks and are at risk for more permanent disability ( 1 ) . To reduce the individual and socioeconomic burden related to this absenteeism , we need effective intervention strategies in occupational health care setting s that promote safe and rapid return to work . One promising and often-advocated intervention strategy for workers with prolonged nonspecific low back pain is active rehabilitation that is directed toward return to normal activity and work ( 2 ) . Examples are grade d activity interventions that include physical exercise , application of operant-conditioning behavioral principals , and promotion of improved functioning and safe return to work even if pain persists ( 3 - 6 ) . In a r and omized , controlled trial , Lindstrm and colleagues ( 3 , 4 ) found that a grade d activity intervention reduced absence from work more than did traditional care in Swedish workers employed in the automobile industry . We investigate , in a second r and omized , controlled trial , whether absence from work because of low back pain is reduced more with grade d activity intervention than with traditional care in an occupational health care setting in the Netherl and s. Methods Study Design and Sample The study was a single-blind , r and omized , controlled trial in an occupational health services center ( KLM Health , Safety and Environment ) at Schiphol Airport , Amsterdam , the Netherl and s. The center provides occupational health services for all employees of a major Dutch airline ( KLM Royal Dutch Airlines ) . The source sample ( n = 20 000 ) consisted of workers who were employed in the following organizational units of the airline : baggage and aircraft turnaround services , passenger services , engineering and maintenance , cargo , and cabin and cockpit . Workers who were listed as absent from work because of low back pain were invited for a consultation with the occupational physician . Those who were thought to be eligible for inclusion were referred to the research assistant , who judged whether they met the inclusion criteria : full or partial absence from work because of nonspecific low back pain and low back pain symptoms with a minimum duration of 4 weeks in succession . The exclusion criteria were low back pain with radiation below the knee with signs of nerve-root compression ( 7 ) ; cardiovascular contraindications for physical activity , as checked according to the Physical Activities Readiness Question naire ( 8 , 9 ) ; any conflict between worker and employer with legal involvement ; or pregnancy . Workers who met the inclusion criteria were informed of the purpose and procedures of the study and were enrolled after giving informed consent . The Medical Ethical Committee of the VU University Medical Center , Amsterdam , the Netherl and s , approved the study . Treatment Allocation The participants were assigned to grade d activity or usual care on the basis of block r and omization , after prestratification for the organizational unit in the workplace from which they were recruited ( the 5 organizational units listed earlier ) and for the severity of pain symptoms ( scored on a scale of 0 to 10 ; severity scores were points ) . This result ed in a total of 10 strata . R and omized , permuted blocks of 4 allocations were generated for each stratum through a computer-generated r and om-sequence table . Opaque , sequentially numbered , sealed envelopes were prepared for each stratum by a research er who was not involved in enrolling the participants or assigning them to their groups . The envelopes contained a sheet of paper that indicated 1 of the 2 interventions . Participants learned their group assignments after a research assistant completed the baseline measurements and delivered the sealed envelopes . Blinding The research assistants who collected the data were blinded to the treatment allocation . All participants were repeatedly asked not to reveal any information about their treatment allocation . The participants and treatment providers were not blinded to treatment allocation . Interventions In the Dutch occupational health care system , occupational physicians guide disabled workers who are absent from work through their disability period . These occupational physicians are employed by occupational health services that are paid for by the companies . The occupational physicians adhere to back pain management strategies that consist of advising workers on ergonomics , prevention , and return-to-work schedules and advising and communicating with other stakeholders ( such as health care providers and representatives of the workplace ) . Disabled workers who participated in the present study were assigned to either grade d activity or usual care within the context of the Dutch occupational health care setting . Grade d Activity The intervention group received the usual guidance from the occupational physician about work-related problems and barriers to return to work as well as the grade d activity intervention supervised by a physiotherapist . Three physiotherapists who worked in a private practice at Schiphol Airport provided the treatment according to the grade d activity protocol . Two of those physiotherapists were also trained as manual therapists , and 1 was also a human movement scientist . Before the study , the physiotherapists had been specifically trained to treat patients with low back pain according to behavioral principles . A research physiotherapist who was experienced in treating patients with chronic pain in rehabilitation centers instructed the physiotherapists in three 2-hour sessions and practice d patienttherapist interactions with them through role-play . Before the study , the physiotherapists treated several patients according to the grade d activity protocol to gain more experience . The physiotherapists made audiotapes of the intervention sessions before and during the study period . The contents of these audiotapes were assessed and discussed with the research physiotherapist in 3 additional meetings . Furthermore , the physiotherapists summarized the treatment after each session , and research ers used these summaries to review the sessions . The same physiotherapist treated participants each time , except for temporary st and -in sessions that were supervised by colleagues because of holidays or other reasons . Specific therapists were not systematic ally selected to treat specific participants ; selection was based on pragmatic reasons , such as the time available in the work schedules of the physiotherapists or the days of treatment preferred by the participants . Table 1 presents the concept and content of the grade d activity intervention . The intervention consisted of 1-hour exercise sessions that participants attended twice per week until they returned completely to regular work or until the maximum therapy duration of 3 months was reached . At the start of the intervention , the physiotherapist inquired about the participant 's medical history and completed a brief physical examination consisting of flexion , extension , and lateroflexion of the lumbar spine and a brief screening for nerve-root pain ( 10 ) . The purpose of the physical examination was to confirm the diagnosis of benign , nonspecific low back pain and to reduce participants ' fears about any presumed underlying disease . The participants were reassured that despite the annoying pain , nothing was seriously wrong with their backs . Subsequently , the physiotherapist and participant decided on a set of general exercises and individually tailored exercises . Both types of exercises had to be performed during each session . The general exercises were aerobic exercises , such as cycling or rowing , and strengthening exercises for large muscle groups , and most were carried out in a gym while using exercise equipment . The strengthening exercises were a floor abdominal sit-up exercise , a dynamic back extension exercise , a leg-press exercise , a latissimus pull-down exercise , and st and ing up from a low chair . Participants in the grade d activity group had to perform not only these general exercises but also individually tailored exercises , which imitated physical tasks at work or difficult and painful activities of daily living . For example , a participant who reported back problems while lifting and moving suitcases from a luggage wagon into an airplane might be given an exercise to practice lifting and moving a suitcase with a certain number of repetitions . During the first 3 sessions , the maximal performance ( for example , the maximum number of repetitions ) was assessed for each exercise separately , and the average score for each exercise over the 3 sessions was used as a baseline value for specifying a gradually progressive exercise scheme . Subsequently , the participant was asked to propose a date for full return to regular work , which would consequently be the end point of the physical exercise program . Before returning to full regular work , participants could return to work with modified hours and duties . Advised by the physiotherapist , the participant",
"& NA ; An outpatient multimodal cognitive‐behavioural treatment program ( MMCBT ) for chronic spinal pain was evaluated during an 18‐month follow‐up period . The treatment included a 1‐day course for the patients ’ work supervisors . The aim of the study was to evaluate the long‐term effect of the treatment program as well as the effect of a work supervisor‐training program on the patients ’ return to work . The design was a matched cohort study with four repeated measures . Two groups of subjects suffering from non‐specific spinal pain ( treatment group n=67 , no treatment control group n=29 ) were assessed with regard to pain intensity , sick‐leave , pain coping ability and behavioural changes at work and in personal life . Recordings on supervisors attending the course and changes of supervisory behaviour were also obtained . The results show a significant between group difference in pain intensity and perceived pain coping ability at work , favouring the MMCBT group . Further , the MMCBT intervention enhances self‐reported behavioural changes in areas within the subjects ’ own control . There is not sufficient statistical support to accept the assumption of MMCBT being superior in reducing sick‐leave , either with or without the education of supervisors . Even when supervisors changed their behaviour as reported by the patient , no significant effect was found on patients ’ return to work . In conclusion , the MMCBT do not seem to be effective in reducing sick‐leave compared to no treatment , but the MMCBT program is superior in decreasing pain intensity , enhancing self‐reported behavioural changes in personal life and improving pain coping ability at work",
"Study Design . This was a prospect i ve study . Objectives . To evaluate the results of education and early rehabilitation in the prevention of back pain chronicity in coal mine workers . Summary of Background Data . A new mine was established in central Queensl and , Australia . Preventing chronicity is important in the treatment of back pain in the industrial setting , because back pain is often refractory to treatment . Back pain patients also constitute the majority of compensation cl aims . Methods . A back pain program was instituted that comprised work force education , early injury reporting , first aid at the mine , and changing workplace psychosocial perceptions . Management employees were actively involved . The time off work , number of cl aims per hundred workers , and costs per cl aim were compared with another mine in the area . Results . The median time to return to work was 10 days . In the study group the number of cl aims and costs per cl aim were significantly less ( P back pain chronicity in the studied group of mine workers , with no worker being off work for more than 60 days ",
"Objectives Major depressive disorder ( MDD ) is associated with absenteeism . In this study , the effectiveness of collaborative care , with a focus on return to work ( RTW ) , was evaluated in its effect on depressive symptoms and the duration until RTW in sick-listed workers with MDD in the occupational health setting . Methods In this r and omised controlled trial , 126 sick-listed workers with MDD were r and omised to usual care ( N=61 ) or collaborative care ( N=65 ) . Collaborative care was applied by the occupational physician care manager , supported by a web-based tracking system and a consultant psychiatrist . Primary outcome measure was time to response . Secondary outcome measures were time to remission , depressive symptoms as continuous measure and the duration until full RTW . Results Collaborative care participants had a shorter time to response , with a difference of 2.8 months . However , no difference was found on time to remission or depressive symptoms as continuous measure . With a mean of 190 days in the collaborative care group , and 210 days in the usual care group , the groups did not differ significantly from each other in the duration until full RTW . Adherence to the collaborative care intervention was low . Conclusions These results do not justify a widespread implementation of collaborative care in occupational healthcare , as it was operationalised in this study . However , since the study might have been underpowered for RTW and because treatment integrity was low , further research , with larger sample sizes , is needed to develop the best fitting ( collaborative care ) model for addressing RTW in depressed sick-listed workers . Trial registration : IS RCT",
"Study Design . A prospect i ve cohort . Objectives . To compare the effectiveness of st and ard care , early intervention treatment , and occupational management in the management of Workers ’ Compensation injury cl aims . Summary of Background Data . The current management of occupational back pain and work-related upper extremity disorders with either st and ard care or early intervention treatment appears to be ineffective . Methods . A prospect i ve cohort looked at the effect of one company with access to st and ard care ( primary care ) changing to occupational management ( worksite encouragement to resume activity and work as soon as safely possible ) and then to early intervention treatment ( offsite work hardening ) . This information was then compared with the control company with access to early intervention treatment , which later changed to a combined occupational management/early intervention treatment approach . Survival analysis was used to attempt to explain differences in time to injury cl aim closure . Results . Occupational management result ed in lower injury cl aim incidence , duration , and costs than early intervention treatment . Only the covariate of enhanced physical therapist ( work hardening ) involvement ( 2001 hazard rate ratio 17.41 , 95 % confidence interval 3.72–41.51 and 2002 hazard rate ratio 6.22 , 95 % confidence interval 2.51–15.40 ) was associated with delayed time to injury cl aim closure when the company had access to early intervention treatment . Only the covariate of serious injury was associated with delayed time to injury cl aim closure in the company when it had access to occupational management ( hazard rate ratio 1.67 , 95 % confidence interval 1.05–27.20 ) . Conclusions . It is recommended that an occupational management approach , in comparison to early intervention treatment and st and ard care , be considered for management of occupational injuries",
"OBJECTIVES The purpose of this study was to assess the effects of early part-time sick leave on return to work ( RTW ) and sickness absence among patients with musculoskeletal disorders . METHODS A r and omized controlled trial was conducted in six occupational health units of medium- and large-size enterprises . Patients aged 18 - 60 years with musculoskeletal disorders ( N=63 ) unable to perform their regular work were r and omly allocated to part- or full-time sick leave . In the former group , workload was reduced by restricting work time by about a half . Remaining work tasks were modified when necessary , as specified in a \" fit note \" from the physician . The main outcomes were time to return to regular work activities and sickness absence during 12-month follow-up . RESULTS Time to RTW sustained for ≥4 weeks was shorter in the intervention group ( median 12 versus 20 days , P=0.10 ) . Hazard ratio of RTW adjusted for age was 1.60 [ 95 % confidence interval ( 95 % CI ) 0.98 - 2.63 ] and 1.76 ( 95 % CI 1.21 - 2.56 ) after further adjustment for pain interference with sleep and previous sickness absence at baseline . Total sickness absence during the 12-month follow-up was about 20 % lower in the intervention than the control group . Compliance with the intervention was high with no discontinuations of part-time sick leave due to musculoskeletal reasons . CONCLUSIONS Early part-time sick leave may provide a faster and more sustainable return to regular duties than full-time sick leave among patients with musculoskeletal disorders . This is the first study to show that work participation can be safely increased with early part-time sick leave",
"Objectives To evaluate whether adjuvant occupational therapy ( OT ) can improve the effectiveness of treatment-as-usual ( TAU ) in sick-listed employees with major depression . Methods In total , 117 employees sick-listed for a median duration of 4.8 months ( IQR=2.6 to 10.1 months ) because of major depression were r and omised to TAU ( n=39 ) or adjuvant OT ( TAU+OT ; n=78 ) . OT ( 18 sessions ) focussed on a fast return to work ( RTW ) and improving work-related coping and self-efficacy . The primary outcome was work participation ( hours of absenteeism+ duration until partial/full RTW ) . Secondary outcomes were depression , at-work functioning , and health-related functioning . Intermediate outcomes were work-related , coping and self-efficacy . Blinded assessment s occurred at baseline and 6 , 12 and 18 months follow-up . Results The groups did not significantly differ in their overall work participation ( adjusted group difference=−1.9 , 95 % CI −19.9 to + 16.2 ) . However , those in TAU+OT did show greater improvement in depression symptoms ( −2.8 , −5.5 to −0.2 ) , an increased probability of long-term symptom remission ( + 18 % , + 7 % to + 30 % ) , and increased probability of long-term RTW in good health ( GH ) ( + 24 % , 12 % to 36 % ) . There were no significant group differences in the remaining secondary /intermediate outcomes . Conclusions In a highly impaired population , we could not demonstrate significant benefit of adjuvant OT for improving overall work participation . However , adjuvant OT did increase long-term depression recovery and long-term RTW in GH ( ie , full RTW while being remitted , and with better work and role functioning ) . Trial Registration Dutch Trial Register NTR2057",
"& NA ; The current investigation studied the effectiveness of a secondary prevention program for nurses with back pain who were deemed at risk for developing a chronic problem . A 2 × 3 repeated measures design was employed with 2 groups and 3 assessment periods . The treatment group received an intervention design ed to reduce current problems , but above all to prevent reinjury and minor pains from becoming chronic medical problems , and it included a physical and behavioral therapy package . The control group was placed on a waiting‐list . Results indicated that the treatment group had significantly greater improvements than the control group for pain intensity , anxiety , sleep quality and fatigue ratings , observed pain behavior , activities , mood , and helplessness . These differences were generally maintained at the 6 month follow‐up . In addition , the treatment group broke a trend for increasing amounts of pain‐related absenteeism , while the control group did not . Taken as a whole , the results suggest that a secondary prevention program aim ed at altering life style factors may represent an effective method for dealing with musculoskeletal pain problems",
"In a prospect i ve , r and omized study , primarily design ed to test the efficacy of activation on consecutive blue-collar workers sick-listed for 6 weeks due to subacute low back pain , 25 % of the workers were excluded for medical reasons . In the intervention study ( n = 103 ) , only a minority of cases ( 6 % ) had ' true ' subacute complaints , i.e. no prior history of low back pain . Subjective reports on general well-being , health status and work-related ergonomic factors were significantly lower or worse in patients than in reference sample s. The r and omized intervention study could establish a significant effect of grade d activation on work return , but the effect seemed to be restricted to patients moderately disabled , i.e. one-third of the subacute low back pain patients included . A predictive four-factor model on work return increased the possibility of identifing nonresponders ( chronic low back pain ) more than threefold with a specificity ( 91 % ) and sensitivity ( 74 % ) comparable to that of clinical disc herniation . The history of a prolonged disablement process , cognitive factors , pain behavior and mentally straining ergonomic factors seemed to be of importance . Psychological reactions , or ' barriers to recovery ' , were slightly different in treatment and control groups but the type of intervention did not significantly alter the predictive model , suggesting that subsets of the study sample may benefit from other optional functional approaches . Descriptive characteristics of the study sample emphasized that subacute low back pain patients can not be conceptualized as a homogeneous group . Four sub-groups could be identified : ( a ) specific medical disorders ; ( b ) spontaneous recovery group ; ( c ) moderately disabled back pain patients ; and ( d ) nonresponders . The results support proposals that treatment should be tailored according to individual needs and that better case management should have priority for those belonging to the nonresponder group",
"OBJECTIVE Validation of a salutogenic theory for return to work ( RTW ) and an associated program process theory . METHODS A longitudinal non-r and omized one-year trial study design was used with a two-year follow-up and with comparison to a reference group . Changes in attitudes and active behaviour in the intervention group and at the workplace were supported by cognitive and behavioural approaches . PARTICIPANTS The intervention group included 118 unskilled Danish public employees and privately employed house-cleaners on sick leave due to musculoskeletal and /or common mental illnesses . RESULTS Significant improvements of work ability index and perceived health ( SF36 subgroups ) were reported . A significantly higher RTW and a shorter sick leave than in the reference group also emerged . Positive predictors of RTW were keeping the pre-sick-leave job and improving work ability index and physical impairment/role physical . Decline in self-efficacy was a negative predictor . CONCLUSIONS Support for the theory and associated program process theory was found . The intervention seemed to influence RTW and the employees ' attitudes , behaviour and health by affecting comprehensibility , meaningfulness and manageability . Sustainable RTW emerged from a synergism of support from the work place and improved personal re sources , especially such as concern mental health . The approach is consistent with integrating health promotion in RTW",
"STUDY DESIGN A 2-year prospect i ve inception cohort study of back injury in nurses . OBJECTIVES To determine the extent to which characteristics of nurses , of the injury , and of the workplace predict occurrence and duration of time loss from work after back injury . SUMMARY OF BACKGROUND DATA During 2 years , 320 nurses incurred 416 back injuries at a large teaching hospital in Winnipeg , Canada . Nurses injured on preselected wards were targeted for early intervention , including provision of modified work , whereas nurses injured on other wards received the usual care . METHODS Time loss attributable to the back injury during the 6 months after injury was analyzed . Three statistical models were used to examine occurrence of time loss ( logistic regression ) , duration of time loss ( Tobit regression ) , and duration of time loss once an injury incurring time loss had been documented ( least-squares regression ) . RESULTS In 218 of the 416 injuries , the injured nurse consented to interview . Whereas perceived disability was related to whether a time loss injury would ensue , self-reported pain was strongly related to the duration of time loss once an injury had become a time loss injury . Duration of time loss was reduced by participation in the return-to-work program . Mechanism of injury , specifically injury occurring while lifting patients , result ed in greater time loss . CONCLUSIONS Focusing on reducing the perception of disability at the time of injury is critical to preventing time loss , but once time loss has occurred , offer of modified work and attention to pain reduction are warranted . The findings add to the evidence that workplace-based intervention programs can be effective in reducing the morbidity result ing from back injury",
"The aim of this study was to compare the effectiveness of work-related cognitive-behavioral treatment ( W-CBT ) with that of cognitive-behavioral treatment as usual ( CBT-AU ) for employees on sick leave as a result of a major depressive disorder ( MDD ) . We collected data for 26 matched out patients at pre- and posttreatment , as well as at 1-year follow-up . Outcome measures were the days of incapacity to work ( DIW ) as well as self-report measures ( Beck Depression Inventory [ BDI ] , Symptom Checklist 90-R [ GSI ] , Life Satisfaction Question naire [ FLZ ] ) . We analyzed data with hierarchical linear modeling in a 2-level model . Therapy effects were defined in 3 ways : effect size ( ES ) , response ( based on the reliable change index ) , and remission compared with the general population 's symptom level . The DIW were reduced significantly after both types of treatment , but employees showed even fewer DIW after W-CBT . At follow-up , significantly more employees were working as a result of W-CBT than with CBT-AU . Significant improvements on scores of self-rating measures corresponded with moderate-to-large effect sizes for both treatment types . Approximately 2 thirds of the treated employees were categorized as unimpaired on BDI scores at posttreatment and at follow-up . At least 1 half of the employees were classified as unimpaired on GSI scores at both assessment points . In future research , a r and omized controlled trial should be conducted using a larger sample size to investigate the impact of moderators ( e.g. , employees at different branches of the company ) . Findings provided support for using common CBT techniques to enhance return to work without losing expected improvements at the symptom level",
"Objectives To evaluate the effectiveness of a participatory workplace intervention compared with usual care for sick-listed employees with distress , with regard to return to work ( RTW ) within the 12-month follow-up . Methods Employees with distress and sick-listed for 2–8 weeks were r and omised to a workplace intervention ( n=73 ) or to usual care ( n=72 ) . The participatory workplace intervention is a stepwise process involving the sick-listed employee and their supervisor , aim ed at reducing obstacles for RTW by reaching consensus about an action plan for RTW . Outcome variables were lasting RTW , cumulative sickness absence and stress-related symptoms . Results Overall , an HR of 0.99 ( 95 % CI 0.70 to 1.39 ) indicated no effect of the workplace intervention on lasting RTW . However , the workplace intervention significantly reduced the time until lasting RTW for employees who at baseline intended to return to work despite symptoms with an HR of 2.05 ( 95 % CI 1.22 to 3.45 ) . Employees who intended to return to work despite symptoms returned to work after 55 days in the workplace intervention group and 120 days in the usual care group . No such effect of the intervention was found for employees without baseline intentions to return to work despite symptoms ( HR=0.78 , 95 % CI 0.47 to 1.28 ) . Conclusions No overall effect of the participatory workplace intervention on lasting RTW was found . The workplace intervention appeared effective on lasting RTW for employees who at baseline intended to return to work despite symptoms . For employees who showed no baseline intention to return to work , the intervention did not have any effect . Other approaches are needed for this subgroup . This trial has been registered at the Dutch National Trial Register IS RCT N92307123",
"Introduction In an earlier study , Gatchel et al. ( J Occup Rehabil 13:1–9 , 2003 ) demonstrated that participants at high risk for developing chronic low back pain disability ( CLBPD ) , who received a biopsychosocial early intervention treatment program , displayed significantly more symptom improvement , as well as cost savings , relative to participants receiving st and ard care . The purpose of the present study was to exp and on these results by examining whether the addition of a work-transition component would further strengthen the effectiveness of this early intervention treatment . Methods Using an existing algorithm , participants were identified as being high-risk ( HR ) or low-risk ( LR ) for developing CLBPD . HR participants were then r and omly assigned to one of three groups : early intervention ( EI ) ; early intervention with work transition ( EI/WT ) ; or st and ard care ( SC ) . Participants provided information regarding pain , disability , work status , and psychosocial functioning at baseline , periodically during treatment , and again 1 year following completion of treatment . Results At 1-year follow-up , no significant differences were found between the EI and EI/WT groups in terms of occupational status , self-reports of pain and disability , coping ability or psychosocial functioning . However , significant differences in all these outcomes were found comparing these groups to st and ard care . Conclusion The addition of a work transition component to an early intervention program for the treatment of ALBP did not significantly contribute to improved work outcomes . However , results further support the effectiveness of early intervention for high-risk ALBP patients",
"Objective : To evaluate the cost-effectiveness and cost-utility of a return to work ( RTW ) program for workers on sick-leave due to low back pain ( LBP ) , comparing a workplace intervention implemented between 2 to 8 weeks of sick-leave with usual care , and a clinical intervention after 8 weeks of sick-leave with usual care . Design : Economic evaluation alongside a r and omised controlled trial ( RCT ) . Study population : Workers sick-listed for a period of 2 to 6 weeks due to LBP . Interventions : 1 . workplace assessment , work modifications and case management ) . 2 . physiotherapy based on operant behavioural principles . 3 . usual care : provided by an occupational physician . Outcomes : The primary outcome was return to work ( RTW ) . Other outcomes were pain intensity , functional status , quality of life and general health . The economic evaluation was conducted from a societal perspective . Outcomes were assessed at baseline ( after 2–6 weeks on sick-leave ) , and 12 weeks , 26 weeks , and 52 weeks after the first day of sick-leave . Results : The workplace intervention group returned to work 30.0 days ( 95 % CI=[3.1 , 51.3 ] ) earlier on average than the usual care group at slightly higher direct costs ( ratio of 1 day : € 19 ) . Workers in the clinical intervention group that had received usual care in the first 8 weeks returned to work 21.3 days ( 95 % CI= [ −74.1 , 29.2 ] ) later on average . The group that had received the workplace intervention in the first 8 weeks and the clinical intervention after 8 weeks returned to work 50.9 days ( 95 % CI=[−89.4 , −2.7 ] ) later on average . A workplace intervention was more effective than usual care in RTW at slightly higher costs and was equally effective as usual care at equal costs on other outcomes . A clinical intervention was less effective than usual care and associated with higher costs . Conclusion : The workplace intervention results in a safe and faster RTW than usual care at reasonable costs for workers on sick-leave for two to six weeks due to LBP",
"OBJECTIVES --The aim was to combat occurrence of chronic occupational back pain . METHODS --A multidisciplinary model to manage back pain that includes both clinical and ergonomic approaches has been developed . Early detection , early clinical and ergonomic evaluations , and early active treatment make up the cornerstone of management . Detection of cases starts after four weeks of absence from work . An ergonomic intervention is implemented at six weeks . A medical specialist is involved at eight weeks . If return to work is not possible after 12 weeks , a functional recovery therapy followed by a therapeutic return to work is implemented . A multidisciplinary team decides if return to original or modified work is possible or if vocational rehabilitation is necessary . This model has been implemented by the investigators in the Sherbrooke ( Quebec , Canada ) area , and is presently being evaluated through a r and omised trial in 31 industrial settlements ( about 20,000 workers ) . A cluster r and omisation of industries and workers will allow separate testing of ergonomic and clinical interventions . RESULTS --One year after implementation , 31 of 35 of the eligible industrial sites participated in the study and 79 of 88 of the eligible workers affected by recent back pain had agreed to participate . Ergonomic and clinical interventions have been implemented as planned . Only three workers dropped out . Hence this global clinical and ergonomic management programme has been shown to be feasible in a general population . CONCLUSION --A global management programme of back pain joining ergonomic and clinical intervention with a multidisciplinary approach has not been tested yet . Linking these two strategies in a same multidisciplinary team represents a systemic approach to this multifactorial ailment . During the first year of this trial we did not find any conflict between these two interventions from the employer 's or worker 's point of view",
"Study Design . R and omized controlled trial . Objectives . To Investigate the long-term effectiveness , costs , and effect modifiers of a mini-intervention , provided in addition to the usual care , and the incremental effect of a worksite visit for patients with subacute disabling low back pain ( LBP ) . Summary of Background Data . A mini-intervention was earlier proved to be an effective treatment for subacute LBP . Whether the beneficial effect is sustained is not known . Furthermore , modifiers of a treatment effect are largely unknown . Methods . A total of 164 patients with subacute LBP r and omized into a mini-intervention ( A , n = 56 ) , a mini-intervention plus a worksite visit ( B , n = 51 ) , or the usual care ( C , n = 57 ) . Mini-intervention consisted of a detailed assessment of the patients ’ history , beliefs , and physical findings by a physician and a physiotherapist , followed by recommendations and advice . The usual care patients received the conventional care . Pain , disability , health-related quality of life , satisfaction with care , days on sick leave , and health care consumption and costs were measured during a 24-month follow-up . Thirteen c and i date modifiers were tested for each outcome . Results . There were no differences between the three treatment arms regarding the intensity of pain , the perceived disability , or the health-related quality of life . However , mini-intervention decreased occurrence of daily ( A vs. , C , P = 0.01 ) and bothersome ( A vs. C , P pain and increased treatment satisfaction . Costs result ing from LBP were lower in the intervention groups ( A 4670 Euros , B 5990 Euros ) than in C ( C 9510 Euros ) ( A vs. C , P = 0.04 ; and B vs. C , not significant ) . The average number of days on sick leave was 30 in A , 45 in B , and 62 in C ( A vs. C , P = 0.03 ; B vs. C , not significant ) . The perceived risk for not recovering was the strongest modifier of treatment effect . Mental and mental-physical workers in A and B were less often on sick leave than those in C. Conclusions . Mini-intervention is an effective treatment for subacute LBP . Despite lack of a significant effect on intensity of low back pain and perceived disability , mini-intervention , including proper recommendations and advice , according to the “ active approach , ” is able to reduce LBP-related costs . The perceived risk of not recovering was the strongest modifier of treatment effect . In alleviating pain , the intervention was most effective among the patients with a high perceived risk of not recovering",
"Purpose . The aim of this study was to determine the impact of a vocational training programme on short- and long-term results after psychosomatic rehabilitation . Method . 1,590 in patients were screened for vocational integration . A high-risk group of 266 patients was r and omly assigned to the vocational training programme plus psychosomatic treatment ; treatment- as- usual served as a control condition . An occupational training was conducted at local companies , closely integrated into psychosomatic treatment . Vocational attitudes and adjustment were studied at intake , discharge , three , 12 and 24 month follow-ups . Results . More than half of the study participants were unemployment and /or long-term work-disabled harbouring strong negative attitudes toward return to work . Forty-six percent of the intervention group declined from participation , but complied with follow-up investigation . At discharge , participants of the vocational training programme had become more optimistic regarding resuming work . One year following discharge , participants of the training programme reported less absence from work . After 24 months , vocational adjustment had improved considerably among programme participants , and declined among controls and refusers . Conclusion . An intensive vocational training programme is effective in promoting positive attitudes to work , reducing work disability and promoting return-to-work . However , a r and omized design may be not optimal ; evaluation necessitates long-term follow-up",
"Study Design . A pre‐ versus postintervention with concurrent control group design was used to investigate the effect of a workplace‐based early intervention program on perception of disability in nurses with low back injury . Objectives . This report examines changes over time in the components of the Oswestry Low Back Pain and Disability Question naire in two groups of back‐injured nurses‐those who received the early intervention program ( study ) and those who were not offered the program ( control ) . Summary of Background Data . Early intervention programs can decrease morbidity , time lost from work , and compensation costs . Although perception of disability decreases , some residual disability remains , the nature of which is not clear . Methods . The Oswestry Low Back Pain and Disability Question naire scores of 40 study nurses and 118 control nurses at time of injury and at 6 months after injury were examined . Analysis of variance was used to compare changes in mean overall scores over time . The proportion of nurses reporting disability on individual components of the Oswestry Low Back Pain and Disability Question naire at each time period was compared with the results of a chi‐square test . Results . Overall Oswestry Low Back Pain and Disability Question naire scores were similar between study and control nurses at time of injury , but were significantly lower in study nurses at 6 months after injury . However , scores of individual Oswestry Low Back Pain and Disability Question naire components that related to job dem and s increased over time ; this was most apparent in lifting , particularly in study nurses . Conclusions . Although overall perception of disability decreased 6 months after injury , particularly in study nurses , disability in job‐related activities persisted . Residual disability after back injury should be addressed in workplace‐based prevention programs",
"Study design . Population -based r and omized controlled trial . Objective . To assess the effectiveness of workplace intervention and grade d activity , separately and combined , for multidisciplinary rehabilitation of low back pain ( LBP ) . Summary of Background Data . Effective components for multidisciplinary rehabilitation of LBP are not yet established . Methods . Participants sick-listed 2 to 6 weeks due to nonspecific LBP were r and omized to workplace intervention ( n = 96 ) or usual care ( n = 100 ) . Workplace intervention consisted of workplace assessment , work modifications , and case management involving all stakeholders . Participants still sick-listed at 8 weeks were r and omized for grade d activity ( n = 55 ) or usual care ( n = 57 ) . Grade d activity comprised biweekly 1-hour exercise sessions based on operant-conditioning principles . Outcomes were lasting return to work , pain intensity and functional status , assessed at baseline , and at 12 , 26 , and 52 weeks after the start of sick leave . Results . Time until return to work for workers with workplace intervention was 77 versus 104 days ( median ) for workers without this intervention ( P = 0.02 ) . Workplace intervention was effective on return to work ( hazard ratio = 1.7 ; 95 % CI , 1.2–2.3 ; P = 0.002 ) . Grade d activity had a negative effect on return to work ( hazard ratio = 0.4 ; 95 % CI , 0.3–0.6 ; P functional status . Combined intervention had no effect . Conclusion . Workplace intervention is advised for multidisciplinary rehabilitation of subacute LBP . Grade d activity or combined intervention is not advised",
"OBJECTIVE To identify subgroups of workers absent from work due to low back pain who are more or less likely to return to work earlier as a result of a grade d activity intervention , and to investigate whether this intervention is effective in reducing pain-related fears and if so , whether these reductions in pain-related fears mediate return to work . METHODS A subgroup analysis was conducted on data from a previous r and omized controlled trial of 134 Dutch airline workers , which found that a behaviorally-oriented grade d activity intervention was more effective than usual care in stimulating return to work . The subgroup analyses added interaction terms to a Cox regression model that described the relationship between treatment allocation and return to work over 12 months of followup . Furthermore , we studied the effects of grade d activity on pain-related fears and added variables indicating a reduction in pain-related fears to the model in order to investigate their influence on return to work . RESULTS Statistically significant interactions were found for disability , fear-avoidance beliefs about physical activity , and fear-avoidance beliefs about work . No indication was found that the reduction in pain-related fears in the grade d activity group mediated more favorable return-to-work results in this group . CONCLUSION Workers who perceive their disability to be moderate and workers with moderate scores for fear-avoidance beliefs return to work more rapidly as a result of the grade d activity intervention than workers with higher scores . The return to work of workers receiving the grade d activity intervention is possibly independent from the reductions in pain-related fears caused by this intervention",
"Study Design . A r and omized controlled trial in occupational health practice was conducted . Objective . To study the efficacy of early management of workers with low back pain by occupational physicians , as compared with management by the supervisor only . Summary of Background data . Health care and university workers with back pain and on sick leave for less than 1 month were included in the study . Methods . Patients with low back pain for at least 10 days on sick leave were r and omly assigned to early management by the occupational physician ( n = 61 ) or to a reference group with management by the worker ’s supervisor during the first 3 months of sick leave ( n = 59 ) . The patients were observed for 1 year and compared in terms of time until return to work , pain intensity , functional disability , and general health perception . The occupational physicians were provided with management guidelines . Results . No significant differences were found after 3 and 12 months of follow-up evaluation in terms of time until return to work ( hazard ratio , 1.3 ; 95 % CI , 0.90–1.90 ) or in terms of other health outcomes . Recurrences , however , occurred more frequently in the intervention group , but the total duration of sick leave in 1 year did not differ between the groups . Conclusions . The findings do not show a significant positive effect of an early intervention by occupational physicians on workers with low back pain . This might reflect the early phase of disability or the low intensity of the intervention result ing from overestimation of the physicians ’ compliance with the guidelines",
"Objectives Workers with common mental disorders ( CMDs ) frequently experience recurrent sickness absence but interventions to prevent this are lacking . The goal of this study was to evaluate the effectiveness of the Stimulating Healthy participation And Relapse Prevention at work intervention in preventing recurrent sickness absence in workers who returned to work after sickness absence due to CMDs . Methods We performed a cluster-r and omised controlled trial with 3 months , 6 months and 12 months follow-up . Treatment providers were r and omised to either a 2-day training in the Stimulating Healthy participation And Relapse Prevention at work intervention , that is , a problem-solving intervention , or usual care . Primary outcome measures were the incidence of recurrent sickness absence and time to recurrent sickness absence . Secondary outcome measures were mental health complaints , work functioning and coping behaviour . Results 80 participants were r and omised in the intervention group and 78 in the control group . The adjusted OR for the incidence of recurrent sickness absence was 0.40 ( 95 % CI 0.20 to 0.81 ) and the adjusted HR for time to recurrent sickness absence was 0.53 ( 95 % CI 0.33 to 0.86 ) for the intervention group compared with care as usual . Conclusions This study demonstrates the 12-month effectiveness of a problem-solving intervention for reducing recurrent sickness absence in workers with CMDs and emphasises the importance of continuous attention in the post return to work phase for workers who have been on sickness absence due to CMDs"
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41173b7e-06ff-11f0-808a-c43d1ab1c353
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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
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"To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results",
"Context Clinicians rely on systematic review s for current , evidence -based information . Contribution This survival analysis of 100 meta-analyses indexed in ACP Journal Club from 1995 to 2005 found that new evidence that substantively changed conclusions about the effectiveness or harms of therapies arose frequently and within relatively short time periods . The median survival time without substantive new evidence for the meta-analyses was 5.5 years . Significant new evidence was already available for 7 % of the review s at the time of publication and became available for 23 % within 2 years . Implication Clinical ly important evidence that alters conclusions about the effectiveness and harms of treatments can accumulate rapidly . The Editors Systematic review s have become increasingly common in recent years ( 1 ) and are recommended by many as the best sources of evidence to guide both clinical decisions ( 2 ) and health care policy ( 3 ) . For systematic review s to fulfill these roles , their findings must remain relatively stable for at least several years or effective mechanisms must exist for alerting end users to important changes in evidence . Yet , surprisingly little research has assessed the extent to which systematic review s become out of date or the rate at which this occurs ( 47 ) . Some organizations , such as the Cochrane Collaboration , recommend updating systematic review s every 2 years , but few empirical data guide this or other recommendations about updating . We sought to determine how quickly systematic review s meet explicitly defined criteria for changes in evidence of sufficient importance to warrant updating . We also sought to identify predictors of survival time , the time to such important changes in evidence . Survival time might vary depending on many factors , including the type of question posed by the original review ( for example , therapeutic or diagnostic ) , the types of studies included ( for example , r and omized trials or observational studies ) , and whether the systematic review provided quantitative synthesis . To limit such variation , we focused on systematic review s of r and omized , controlled trials that evaluated therapeutic benefit or harm by providing quantitative synthesis ( meta- analysis ) for at least 1 outcome . Methods Study Design and Sample We used a quasi-r and om process ( alphabetical sort order by author ) to select 100 systematic review s that were indexed in ACP Journal Club with an accompanying commentary between January 1995 and December 2005 ( with a search date no later than 31 December 2004 to ensure at least 1 full year for new evidence to appear ) . We chose this sampling frame because ACP Journal Club selects systematic review s that meet explicit quality st and ards and are deemed directly relevant to clinical practice ( 8) . We regarded the sample size of 100 as sufficiently large to achieve suitably narrow confidence intervals and to permit evaluation of up to 5 potential predictors of survival . Eligibility Criteria Eligible review s evaluated the benefit or harm of a specific drug , class of drug , device , or procedure ( invasive procedure or surgery ) and included r and omized or quasi-r and omized , controlled trials . We excluded evaluations of alternative and complementary medicines because the stability of review s of such therapies might differ substantially from review s of conventional therapies . We required that review s provide a point estimate and 95 % confidence interval for at least 1 outcome in the form of a relative risk , odds ratio , or absolute risk difference for binary outcomes and weighted mean differences for continuous outcomes . We excluded meta-analyses of individual-patient data , meta-regressions , and indirect meta-analyses because of the difficulty of determining whether new data would alter previous quantitative results . Two team members independently assessed eligibility , with disagreements resolved by consensus involving a third review er . When more than 1 review on the same topic was identified , only the earliest was included . Search ing For each review , search es for new trials included identifying new systematic review s on the same topic , su bmi tting relevant content terms to the Clinical Queries function in Ovid , applying the Related Articles function in PubMed to the 3 largest and the 3 most recent trials in the original review ( up to 6 trials in total ) , and using Scopus ( www . scopus .com/ scopus /home.url ) to identify new r and omized trials that cited the original review . When these search strategies yielded no eligible new trials , we conducted more comprehensive electronic search es and review ed relevant chapters in such sources as Clinical Evidence and UpTo Date to ensure that we had not missed new trials . Team members who had background s in both medicine and clinical research screened citations retrieved by the preceding methods to identify trials that would have met the inclusion criteria in the original review . Retrieved articles were screened in chronological order to ascertain quantitative or qualitative signals for the need for updating . The review protocol stopped when any criteria for updating were met . Each systematic review was discussed in detail , with the final statussignal for updating was or was not detectedadjudicated by consensus ( Figure 1 ) . Figure 1 . Overall process for determining updating status . ACP Journal Club Signals for the Need to Up date Systematic Review s In design ing criteria for comparing new findings with those in a previous review , we adapted methods used by other investigators to address similar problems with comparing 2 sets of results relating to the same question ( 913 ) , such as r and omized and nonr and omized studies of the same intervention . These investigators identified conflicting findings among different publications using a combination of quantitative thresholds for differences in effect magnitude and qualitative judgments about the language used to describe the results . We have similarly conceptualized quantitative and qualitative signals of potential changes in evidence that are sufficiently important to warrant updating previous systematic review s. Quantitative Signals Quantitative signals consisted of a change in statistical significance or relative change in effect magnitude of at least 50 % . We restricted these changes to those involving 1 of the primary outcomes of the original review or any mortality outcome . We also ignored trivial changes in statistical significance when the original and up date d meta-analytic results both had P values between 0.04 and 0.06so that quantitative signals of changes in evidence would represent robust indicators of the need to up date previous review s. Quantitative signals were detected by combining data from eligible new trials with the previous results using a fixed-effects approach . Use of fixed-effect models allowed pooling of the new trials with the previous meta-analytic result , as opposed to having to obtain original data from all of the included trials in each of 100 systematic review s. Although r and om-effects models are usually preferred to avoid spurious precision in the face of heterogeneity , our goal was to detect potential changes in evidence that would warrant a formal up date , not produce exact estimates of the up date d results . Qualitative Signals Qualitative signals included new information about harm sufficient to affect clinical decision making , important caveats to the original results , emergence of a superior alternate therapy , and important changes in certainty or direction of effect . Qualitative signals were detected by using explicit criteria for comparing the language in the original review with descriptions of findings in new systematic review s that addressed the same topic , pivotal trials , clinical practice guidelines , or recent editions of major textbooks ( for example , UpTo Date ) . Pivotal trials were defined as trials that had a sample size at least 3 times larger than that of the previous largest trial or were published in 1 of the 5 highest-impact general medical journals ( The New Engl and Journal of Medicine , Lancet , Journal of the American Medical Association , Annals of Internal Medicine , and the British Medical Journal ) . We defined 2 levels of importance for qualitative signals : potentially invalidating changes in evidence , which would make one no longer want clinicians or policymakers to base decisions on the original findings ( such as a pivotal trial that characterized treatment effectiveness in terms opposite of those in the original systematic review ) , and major changes in evidence , which would affect clinical decision making in important ways without invalidating the previous results ( such as the identification of patient population s for whom treatment is more or less beneficial ) . Major changes also included differing characterizations of effectiveness that were less extreme than those for potentially invalidating signals but that would still affect clinical decision making ( for example , a change from possibly beneficial to definitely beneficial ) . Of importance , such characterizations as possibly effective , probably effective , and promising , were all categorized as possibly effective . Thus , qualitative signals for changes in evidence captured substantive differences in the characterization of treatment effects , not merely semantic differences . Full definitions for each of the specific signals can be found at www.ohri.ca/UpdatingSystRevs . Data Collection For each review , we characterized the clinical content area , eligibility criteria for included trials , definitions of reported outcomes , number of included trials and participants , meta-analytic result for each outcome , identification of statistical heterogeneity , and excerpted quotations of the authors ' characterizations of the main results . We also abstract ed whether a given outcome was explicitly identified as 1 of the primary or main outcomes . We discounted identification of more than 3 such outcomes as inconsistent with the",
"Abstract s on this page have been chosen and edited by Dr Trevor Watts Abstract Failure rates were higher for glass ionomer ( GIC ) , but caries progression was more likely on tooth surfaces adjacent to amalgam ( AM ) restorations",
"The present r and omised clinical trial was aim ed at comparing three minimally invasive restorative treatment approaches for managing dental caries in occlusal surfaces using a non-gamma-2 amalgam and a low-viscosity glass-ionomer as the restorative material . The treatment approaches tested in parallel groups were : conventional in a university setting , modified-conventional and ultraconservative ( Atraumatic Restorative Treatment , ART ) approaches in a field setting . A split-mouth design was used in which the two restorative material s were r and omly placed in 430 matched contralateral pairs of permanent molar teeth . A total of 152 children from five primary schools were recruited and treated by a dental therapist . The restorations were evaluated after 6 years by 2 calibrated independent examiners . The 6-year successes for all occlusal amalgam and glass-ionomer restorations were 72.6 and 72.3 % , respectively . There were no statistically significant differences observed between the successes for both amalgam and glass-ionomer restorations placed either by the ART ( 68.6 % , with 95 % CI = 61–76 % ) approach or by the conventional ( 74.5 % , with 95 % CI = 65–82 % ) and the modified-conventional ( 75.8 % , with 95 % CI = 67–83 % ) approaches after 6 years . There was also no statistically significant difference observed between the successes of occlusal ART restorations with glass-ionomer ( 67.1 % , with 95 % CI = 56–77 % ) and occlusal conventional restorations with amalgam ( 74 % , with 95 % CI = 61–85 % ) after 6 years . ‘ Restoration fracture/marginal defects ’ and ‘ loss of material ’ were the most common causes for failure . The former was more often recorded in amalgam restorations and the latter in glass-ionomer restorations . Secondary caries was observed for 2 % of glass-ionomer and for 10 % of amalgam restorations . This difference was statistically significant ( p = 0.001 ) . The ART approach using glass-ionomer performed equally well as conventional restorative approaches using electrically driven equipment and amalgam for treating dentinal lesions in occlusal surfaces after 6 years",
"OBJECTIVE To compare the survival of glass ionomer cement ( GIC ) restorations placed in a dental clinic setting using both the atraumatic restorative treatment ( ART ) approach with h and instruments , and conventional cavity preparation with rotary instruments . METHOD AND MATERIAL S Two encapsulated high-strength conventional GICs ( Fuji IX GP , Ketac-Molar Aplicap ) were placed in 82 Class I and 53 Class II preparations and one encapsulated non-gamma 2 amalgam alloy ( GK-amalgam ) was placed in 32 Class I preparations , in the primary molars of 60 Chinese children with a mean age of 7.40 + /- 1.24 ( SD ) years . Thus , 9 treatment groups were formed . RESULTS After two years , there were no significant survival differences found among 7 of the 9 treatment groups ( p = 0.99 ) . However , two groups comprising Fuji IX GP and Ketac-Molar Aplicap placed in Class II cavities prepared using the ART approach showed significantly lower restoration survivals ( p GIC material . CONCLUSIONS In a clinic setting , both the ART h and instrument and conventional rotary instrument methods were equally suitable for high Class I restoration survival , but not for Class II restoration survival where the conventional cavity preparation method was preferable",
"The usefulness of fluoride-releasing restorations in secondary caries prevention may be question ed because of the presence of other common sources of fluoride and because of ageing of the restorations . This study tested the hypothesis that glass-ionomer cement restorations , either aged or unaged , do not prevent secondary root caries , when fluoride dentifrice is frequently used . Sixteen volunteers wore palatal appliances in two phases of 14 days , according to a 2 × 2 crossover design . In each phase the appliance was loaded with bovine root dentine slabs restored with either glass-ionomer or resin composite , either aged or unaged . Specimens were exposed to cariogenic challenge 4 times/day and to fluori date d dentifrice 3 times/day . The fluoride content in the biofilm ( FB ) formed on slabs and the mineral loss ( ΔZ ) around the restorations were analysed . No differences were found between restorative material s regarding the FB and the ΔZ , for either aged ( p = 0.792 and p = 0.645 , respectively ) or unaged ( p = 1.00 and p = 0.278 , respectively ) groups . Under the cariogenic and fluoride dentifrice exposure conditions of this study , the glass-ionomer restoration , either aged or unaged , did not provide additional protection against secondary root caries ",
"The aim of this study was to compare the longevity and cariostatic effects of everyday conventional glass-ionomer and amalgam restorations in primary teeth . The material s consisted of 515 Ketac-Fil glass-ionomer restorations and 543 Dispersalloy amalgam restorations prepared in 666 children , from 3 to 13 years of age , by 14 dentists within the Danish Public Dental Health Service in the municipalities of Vaerlose and Hillerød . The restorations , of which 79 % were of the Class II type , were in contact with 593 unrestored surfaces in adjacent primary and permanent teeth . After 3 years , 6 % of the patients had dropped out of the study , and 33 % of the teeth were exfoliated with the restoration in situ . A further 37 % of the glass-ionomer and 18 % of the amalgam restorations were recorded as failed ( p 0.001 ) . The frequency of failures was highest for Class II glass-ionomer restorations , which showed a 50 % median survival time of only 34½ months , because of many fractures , while the 75 % survival time for Class II amalgam restorations just exceeded the actual 36 months ( p 0.001 ) . Caries progression was most often recorded in surfaces adjacent to amalgam restorations , and 21 % of these surfaces needed restorative treatment vs. 12 % of the surfaces adjacent to glass-ionomer restorations ( p that conventional glass ionomer is not an appropriate alternative to amalgam for all types of restorations in primary teeth . In particular , the short longevity of Class II glass-ionomer restorations could not be compensated for by the reduced caries progression and need for restorative therapy of adjacent surfaces",
"Since the last comprehensive review of anticoagulation in acute myocardial infa rct ion four additional r and omized control trials have been reported . The overwhelming majority of all trials favored anticoagulation . Rates of thromboembolism were higher in the control , and hemorrhagic complications in the anticoagulated group . Pooling of all r and omized control trials gives mean case fatality rates of 19.6 % for the control and 15.4 % for the anticoagulated group , a relative reduction of 21 % ( P less than 0.05 or less than 0.001 , depending on the analytic method ) . Five of six r and omized control trials reported \" no effect \" because the difference favoring anticoagulation was not statistically significant . However , sample sizes in these \" negative \" papers were too small to protect against missing a 21 % reduction in true case fatality rate due to anticoagulation ( beta greater than 0.10 ) . All patients who present no specific contraindication should receive anticoagulants during hospitalization for infa rct ion ",
"Previous reports have shown a release of fluoride from glass-ionomer cement ( GIC ) restorations into the oral fluids . Fluoride in the ambient fluids has a caries-preventive effect by enhancing remineralization and inhibiting demineralization of the dental hard tissues . Therefore , the current investigation was undertaken to determine whether GIC fillings could contribute to the remineralization of caries lesions in dentin . Small circular preparations were made in disks of dentin which had incipient caries-like lesions in the remaining tissue . The preparations were filled with amalgam or composite material s ( as controls ) or with GIC . The specimens thus contained a restoration close to a dentinal caries-like lesion . The specimens were placed contralaterally in the buccal surfaces of removable partial dentures and were worn intra-orally by volunteers for a 12-week experimental period , after which the specimens were sectioned and analyzed by microradiography . All specimens with GIC restorations exhibited hypermineralization in the tissue bordering the filling and in the wall of the preparation which had been in contact with the restoration . The ( caries-like ) lesions were remineralized , even under conditions of heavy plaque formation . In contrast , specimens with amalgam or composite restorations showed further extensive demineralization . This study demonstrates a significant remineralization potential exerted by the fluoride-releasing GIC restorative material . Consequently , the choice of the restorative material might be crucial for the occurrence or prevention of recurrent caries around restorations",
"This study compared the survival of restorations produced through the atraumatic restorative treatment ( ART ) approach using glass-ionomer with those produced through the traditional approach using amalgam ( MTA ) in deciduous dentitions over a period of 3 years . Using a parallel group design , 835 grade 1 children , aged 6–7 years , participated . A total of 482 children were treated through the ART and 353 children through the MTA approach . Eight dentists produced a total of 1,891 single- and multiple-surface restorations . After 3 years , 22.1 % of the restorations were lost for evaluation . There was a statistically significant difference in the combined survival of all single- and multiple-surface restorations between the two approaches in favour of the ART approach ( p = 0.04 ) . The study revealed a 3-year cumulative survival percentage of single-surface ART and MTA restorations of 86.1 and 79.6 % , respectively . The difference was statistically significant ( p = 0.03 ) . The main reasons for both single-surface ART and MTA restorations to fail was ‘ restoration missing ’ followed by ‘ gross marginal defect ’ . The 3-year cumulative survival percentages of multiple-surface ART and MTA restorations were 48.7 and 42.9 % , respectively . The difference was not statistically significant ( p > 0.05 ) . The 3-year survival percentages of single- and multiple- surface ART and MTA restorations varied widely amongst the 8 operators with an operator effect ( p = 0.001 ) for multiple-surface MTA restorations . It can be concluded that the ART approach using glass-ionomer yielded better results in treating dentinal lesions in deciduous teeth than did the traditional approach using amalgam after 3 years . It is recommended to select the ART approach to complement the other activities of the school oral health programme",
"The present study was aim ed at comparing the effectiveness of three minimally invasive restorative treatment approaches for dentinal lesions in occlusal surfaces . The approaches tested comprised a conventional and a modified – conventional treatment and a modified Atraumatic Restorative Treatment ( ART ) . The conventional approach was performed in a university dental clinic whilst the modified – conventional , employing portable equipment , and the modified ART , using h and instruments and a caries removal solution ( Caridex ® ) , were carried out in the field . Using the split – mouth design , 430 matched contralateral pairs of occlusal cavities were restored with amalgam or glass – ionomers in permanent molars of 152 school children by one dental therapist . The restorations were assessed using a modified USPHS – Ryge criteria . After 2 years , the cumulative survival percentages for occlusal amalgam and glass – ionomer restorations were 92 and 96 % , respectively . The survival of all restorations in the conventional , modified – conventional and the modified ART group was 96 , 96 and 91 % , respectively . The survival of occlusal amalgam and glass – ionomer restorations per treatment group was as follows : 94 and 99 % , respectively ( conventional group ) ; 95 and 97 % , respectively ( modified – conventional group ) , and 89 and 93 % , respectively ( modified ART group ) . The differences in survival percentage between restorations with amalgam and glass – ionomer , and between the three restorative treatment approaches were not statistically significant . In countries facing scarcity in re sources for dental care , ART seems a promising restorative approach to occlusal caries in posterior teeth . However , a longer clinical observation period is required to substantiate this initial conclusion",
"OBJECTIVE The purpose of this study was to compare the success rates of glass-ionomer cement restorations placed with the atraumatic restorative treatment approach and conventional cavity preparation methods . METHOD AND MATERIAL S Two encapsulated , high-strength , esthetic conventional glass-ionomer cements were placed in 82 Class I and 53 Class II atraumatic restorative treatment and conventional cavity preparations , and an encapsulated amalgam alloy was placed in 32 Class I conventional preparations , in vital primary molars of 60 Chinese children aged 7 to 9 years . RESULTS The atraumatic restorative treatment preparations , made with h and instruments only , took approximately 50 % longer to complete than did the preparations completed with conventional rotary instrumentation . After 1 year , there were no amalgam failures . For the glass-ionomer cement restorations , when the atraumatic restorative treatment method was used , significantly better survival rates were found for Class I ( 92.9 % ) than for Class II ( 64.7 % ) cavity preparations . There was also a strong trend for relatively better survival rates for the conventional cavity preparation method ( 86.7 % ) than for the atraumatic restorative treatment ( 64.7 % ) method for Class II cavity preparations . However , both the atraumatic restorative treatment and conventional methods appeared equally effective for Class I preparations . CONCLUSION In a clinic setting , the use of atraumatic restorative treatment h and instruments for cavity preparation is more time consuming , and the method may also provide less mechanical retention and /or bulk of glass-ionomer cement for some Class II preparations in primary molars than does the use of conventional rotary instruments",
"The atraumatic restorative treatment technique ( ART ) is based on removing infected tooth material using only h and instruments and filling the subsequently cleaned cavity with adhesive material such as glass ionomer . As its name suggests , the ART technique should be atraumatic during treatment , as well as for the tooth itself as for the patient . It was primarily developed for treating people living in underserved areas of the world where re sources and facilities such as electricity and trained manpower are limited . Many studies have evaluated the ART technique and the results have supported its application . However , a very limited number of studies have compared ART with more conventional techniques . For that reason , a study was conducted in Pakistan , to compare the ART technique with another more conventional treatment technique . The results of this study show that the preparations with h and instruments result ed in smaller sized cavities and therefore may be less traumatic to the tooth . It was also associated with less pain reactions compared to the more conventional technique . Although preparations with h and instruments required more time , this did not seem to affect the survival of restorations . The survival of glass ionomer cement restorations made with h and instruments was comparable with single surface amalgam restorations made with a more conventional technique . Recurrent caries was not associated with any glass ionomer cement restorations made with h and instruments . The retention rate of glass ionomer sealants was low , however one dentist had a sealant retention rate of 81.5 percent that suggests that this procedure can be performed satisfactorily in conjunction with a glass ionomer cement restoration . Operator variances did seem to affect the restorations . Survival of glass ionomer restorations made with both h and and rotary instruments varied for different operators . Similarly , the retention of fissure sealant also varied amongst operators . Operator differences also influenced the extent of tooth substance lost due to cavity preparation . The ART technique is a feasible approach towards the treatment of dental caries especially of one-surface lesions for underserved population",
"OBJECTIVE To evaluate the remineralization of carious dentine following the restoration of an extensive lesion in a permanent molar with a high strength glass-ionomer cement ( GIC ) . MATERIAL S AND METHODS Thirteen first permanent molars , which were scheduled for extraction because of the presence of extensive caries lesions , were selected for this study . They were first restored , according to the ART technique , using encapsulated Fuji IX(GP ) , which contains a strontium glass rather than the traditional calcium glass . The cavities were prepared with a clean enamel margin and minimal removal of the carious dentine around the walls . After a period of 1 - 3 months they were harvested and subsequently sectioned and examined using an electron probe micro analysis ( EPMA ) and scanning electron microscopy ( SEM ) . RESULTS EPMA demonstrated that both fluorine and strontium ions had penetrated deep into the underlying demineralized dentine . The only possible source of these ions was the GIC restoration . CONCLUSION The pattern of penetration of the fluorine and strontium ions into the dentine was consistent with a remineralization process",
"OBJECTIVES The Atraumatic Restorative Treatment ( ART ) approach was compared with the traditional amalgam ( TA ) approach in order to test their appropriateness to complement a preventive and educational school oral health programme in Syria . METHODS Using a parallel group design , 370 and 311 grade 2 children were r and omly assigned to the ART and the TA group respectively . Eight dentists placed 1117 single- and multiple-surface restorations . A modified actuarial method was used to estimate survival curves . The jackknife method was applied to calculate the st and ard error in the cumulative survival percentages . RESULTS A statistically significant difference in cumulative survival percentages between single-surface non-occlusal ART and comparable amalgam restorations was observed after 4.3 , 5.3 and 6.3 years . The survival of single-surface non-occlusal ART posterior restorations ( 80.2 + /- 4.9 % ) was statistically significantly higher than that of occlusal posterior ART restorations ( 64.8 + /- 3.9 % ) at evaluation year 6.3 . There was no statistically significant difference observed between survival percentages of large ( 55.8 + /- 10 % ) and that of small ( 69.2 + /- 4.6 % ) single-surface posterior ART restorations after 6.3 years . There was an operator effect observed for single-surface ART and comparable amalgam restorations . Secondary caries was observed in 2.3 % of single-surface ART restorations and in 3.7 % of single-surface amalgam restorations during the 6.3 year observation period . CONCLUSIONS The ART approach provided higher survival percentages for single-surface restorations than the TA approach over 6.3 years and is therefore appropriate for use in school oral health programmes . Secondary caries was only a minor reason for ART restorations to fail . An operator effect was observed for both treatment approaches",
"The None hypothesis tested was that there is no difference in the survival percentages of all restorations placed through the Atraumatic Restorative Treatment ( ART ) approach , with high-viscosity glass ionomer , and those produced through the traditional approach , with amalgam ( TA ) , in the permanent dentitions of children after 6.3 years . Using a parallel group design , we r and omly assigned a total of 370 children , aged 6 to 9 years , to the ART group and 311 children , also aged 6 to 9 years , to the TA group . Eight dentists placed a total of 1117 single- and multiple-surface restorations . The cumulative survival percentages for ART glass-ionomer restorations were statistically significantly higher than those of amalgam restorations at all time intervals except the first ( p ≤ 0.044 ) . After 6.3 years , the cumulative survival percentages of ART and amalgam restorations were 66.1 % ( SE = 3.1 % ) and 57.0 % ( SE = 3.3 % ) , respectively . We concluded that the restorations produced with the ART approach , with high-viscosity glass ionomer , survived longer than those produced with the traditional approach , with amalgam , in the permanent teeth of young children"
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BACKGROUND AND OBJECTIVES : Iron deficiency ( ID ) is the most common cause of anemia worldwide . The prevalence is highest among preschool-aged children . Iron is widely administered to children with or at risk for ID , but evidence of benefit among 2- to 5-year-old children has not been evaluated by systematic review . We summarize the evidence for the benefit and safety of daily iron supplementation with regard to hematologic , growth , and cognitive parameters in 2 to 5 year olds . METHODS : Electronic data bases , regional data bases , thesis repositories , gray literature , and references of studies and previous review s were search ed . We included r and omized controlled trials that compared daily oral iron supplementation with control in 2 to 5 year olds . A r and om-effects meta- analysis was used to synthesize predefined outcomes reported by at least 2 studies . RESULTS : Of 9169 references , 15 studies met the inclusion criteria , none of which were at low risk of bias . Children receiving iron supplementation had a mean end point hemoglobin of 6.97 g/L ( P ferritin was 11.64 µg/L ( P iron supplementation on ID or iron deficiency anemia , and only one reported on anemia . Limited evidence suggested that iron supplementation produced a small improvement in cognitive development but had no effect on physical growth . CONCLUSIONS : In 2 to 5 year olds , daily iron supplementation increases hemoglobin and ferritin . There is a concerning lack of data on the effect of iron supplementation on clinical ly important outcomes including anemia , ID anemia , ID , and cognitive development . Additional interventional studies in this age group are needed
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"In order to determine whether giving iron to iron-deficient children increases their susceptibility to malaria , 213 Gambian children aged between 6 months and 5 years with iron-deficiency anaemia were r and omized to receive either oral iron or placebo during the rainy season when malaria transmission is maximal . Haematological and iron measurements improved significantly in the group given iron . Regular morbidity surveys showed that fever associated with parasitaemia occurred more frequently in the iron-treated group than in the placebo group . This difference was not significant for all parasitaemias grouped together , but became significant and progressively larger for parasitaemias of ten or more positive fields per 100 high power fields ( P less than 0.025 ) , and for parasitaemias of 50 or more positive fields per 100 high power fields ( P less than 0.01 ) . Three children in the iron-treated group but none in the placebo group had more than one episode of fever and parasitaemia . Splenomegaly rates rose appreciably during the study in both groups , but in children at age 2 years the splenomegaly rate at the end of the study was significantly greater in the iron-treated group . We concluded that there is a significantly increased risk of fever associated with severe malarial parasitaemia for children with iron-deficiency anaemia given iron during the season of maximal malaria transmission in this part of The Gambia",
"CONTEXT The evidence that breastfeeding improves cognitive development is based almost entirely on observational studies and is thus prone to confounding by subtle behavioral differences in the breastfeeding mother 's behavior or her interaction with the infant . OBJECTIVE To assess whether prolonged and exclusive breastfeeding improves children 's cognitive ability at age 6.5 years . DESIGN Cluster-r and omized trial , with enrollment from June 17 , 1996 , to December 31 , 1997 , and follow-up from December 21 , 2002 , to April 27 , 2005 . SETTING Thirty-one Belarussian maternity hospitals and their affiliated polyclinics . PARTICIPANTS A total of 17,046 healthy breastfeeding infants were enrolled , of whom 13,889 ( 81.5 % ) were followed up at age 6.5 years . INTERVENTION Breastfeeding promotion intervention modeled on the Baby-Friendly Hospital Initiative by the World Health Organization and UNICEF . MAIN OUTCOME MEASURES Subtest and IQ scores on the Wechsler Abbreviated Scales of Intelligence , and teacher evaluations of academic performance in reading , writing , mathematics , and other subjects . RESULTS The experimental intervention led to a large increase in exclusive breastfeeding at age 3 months ( 43.3 % for the experimental group vs 6.4 % for the control group ; P breastfeeding at all ages up to and including 12 months . The experimental group had higher means on all of the Wechsler Abbreviated Scales of Intelligence measures , with cluster-adjusted mean differences ( 95 % confidence intervals ) of + 7.5 ( + 0.8 to + 14.3 ) for verbal IQ , + 2.9 ( -3.3 to + 9.1 ) for performance IQ , and + 5.9 ( -1.0 to + 12.8 ) for full-scale IQ . Teachers ' academic ratings were significantly higher in the experimental group for both reading and writing . CONCLUSION These results , based on the largest r and omized trial ever conducted in the area of human lactation , provide strong evidence that prolonged and exclusive breastfeeding improves children 's cognitive development . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N37687716",
"BACKGROUND In developing countries , incomplete resolution of anemia with iron supplementation is often attributed to poor compliance or inadequate duration of supplementation , but it could result from deficiencies of other micronutrients . OBJECTIVE Our objective was to assess children 's hematologic response to supervised , long-term iron supplementation and the relation of this response to other micronutrient deficiencies , anthropometry , morbidity , and usual dietary intake . DESIGN Rural Mexican children aged 18 - 36 mo ( n = 219 ) were supplemented for 12 mo with either 20 mg Fe , 20 mg Zn , both iron and zinc , or placebo . Children were categorized as iron-unsupplemented ( IUS ; n = 109 ) or iron supplemented ( IS ; n = 108 ) . Hemoglobin , hematocrit , mean corpuscular volume , mean cell hemoglobin , plasma concentrations of micronutrients that can affect hematopoiesis , anthropometry , and diet were assessed at 0 , 6 , and 12 mo ; morbidity was assessed biweekly . RESULTS At baseline , 70 % of children had low hemoglobin ( low hematocrit , 48 % were ferritin deficient , 10 % had deficient and 33 % had low plasma vitamin B-12 concentrations , 29 % had deficient vitamin A concentrations , and 70 % had deficient vitamin E concentrations . Iron supplementation increased ferritin from 11 + /- 14 microg/L at baseline to 31 + /- 18 microg/L after 6 mo ( P anemia persisted in 30 % and 31 % of supplemented children at 6 and 12 mo , respectively , and was not significantly different between the IUS and IS groups at 12 mo . Initial plasma vitamin B-12 , height-for-age , and dietary quality predicted the hematopoietic response to iron . CONCLUSION Lack of hemoglobin response to iron was associated with indicators of chronic undernutrition and multiple micronutrient deficiencies",
"A r and omized , double-blind , placebo-controlled iron supplementation trial was conducted in Kenya to examine the effect of iron supplements on appetite and growth in 87 primary school children . Sustained-release ferrous sulfate ( 150 mg ) or placebo tablets were provided daily at school for 14 wk . Prior to tablet administration , baseline anthropometry , iron nutritional status ( hemoglobin and serum ferritin ) , parasitic infections and clinical indicators of morbidity were measured . A baseline appetite test was conducted twice on each child by quantitatively measuring the ad libitum consumption of a midmorning snack . In addition , each child was asked for a subjective assessment of his or her appetite . Follow-up exams and appetite tests were identical to those at baseline . Findings indicated that provision of iron supplements result ed in improved growth and improved appetite ( in terms of both energy intake of the snack and child report of appetite ) as compared with children receiving the placebo . The increased energy intake from the snack was 10 % of the daily estimated energy intake for children of this same age group living elsewhere in Kenya . Further research into the underlying physiological mechanisms may shed light on the relationship between iron nutritional status and appetite",
"Conflicting evidence exists on the possible role of iron supplementation in the predisposition to malaria infection or the enhancement of its clinical severity . Where anemia prevalence is > 40 % , current guidelines are to provide low-dose daily iron to young children for up to 18 mo . Earlier studies used doses higher than the current guidelines , intermittent doses , or have supplemented for duration s low-dose , long-term iron supplementation on malaria infection using a double-blind , placebo-controlled , r and omized design , and to examine possible subgroup effects by season and child age . The study was conducted in Pemba Isl and , Zanzibar , where Plasmodium falciparum malaria has year-round high transmission . A community-based sample of 614 children 4 - 71 mo old was r and omly allocated to 10 mg/d iron or placebo for 12 mo . Outcome measures were the prevalence and density of malaria infection , which was assessed by blood films at monthly intervals . At baseline , 94.4 % were anemic ( hemoglobin stunted ( height-for-age Z-score less than -2 ) and > 80 % had malaria-positive blood films . No significant differences in malariometric indices were observed between children in the iron-supplemented and placebo groups . Parasite density was higher in certain months and in younger children , but iron supplementation was not associated with any malarial infection outcome in any season or age subgroup . We conclude that in this environment of high malaria transmission , daily oral low-dose supplementation of iron for 12 mo did not affect the prevalence of malaria infection or parasite density",
"Iron deficiency and helminth infections are two common conditions of children in developing countries . The consequences of helminth infection in young children are not well described , and the efficacy of low dose iron supplementation is not well documented in malaria-endemic setting s. A 12-mo r and omized , placebo controlled , double-blind trial of 10 mg daily iron and /or mebendazole ( 500 mg ) every 3 mo was conducted in a community-based sample of 459 Zanzibari children age 6 - 71 mo with hemoglobin > 70 g/L at baseline . The trial was design ed to examine treatment effects on growth , anemia and appetite in two age subgroups . Iron did not affect growth retardation , hemoglobin concentration or mild or moderate anemia ( hemoglobin serum ferritin and erythrocyte protoporphyrin . Mebendazole significantly reduced wasting malnutrition . but only in children adjusted odds ratios ( AORs ) for mebendazole in this age group were 0.38 ( 95 % CI : 0.16 , 0.90 ) for weight-for-height less than -1 Z-score and 0.29 ( 0.09 , 0.91 ) for small arm circumference . In children mebendazole also reduced moderate anemia ( AOR : 0.41 , 0.18 , 0.94 ) . Both iron and mebendazole improved children 's appetite , according to mothers ' report . In this study , iron 's effect on anemia was limited , likely constrained by infection , inflammation and perhaps other nutrient deficiencies . Mebendazole treatment caused unexpected and significant reductions in wasting malnutrition and anemia in very young children with light infections . We hypothesize that incident helminth infections may stimulate inflammatory immune responses in young children , with deleterious effects on protein metabolism and erythropoiesis",
"Ninety-nine anemic children aged 1 - 8 y were divided into four groups . Each group was supplemented for 2 mo with vitamin A , iron , vitamin A plus Fe , or a placebo . Clinical , hematological , and Fe biochemical evaluations were performed at the beginning and end of the study . Vitamin A supplementation produced significant elevations in the serum levels of retinol , blood hemoglobin , hematocrit , erythrocytes , serum Fe , and percent transferrin saturation ( % TS ) and had no effect on total Fe binding capacity ( TIBC ) or serum ferritin . Fe supplementation did not affect serum retinol . However , it improved hematological and Fe nutrition indicators , including TIBC and serum ferritin . The simultaneous administration of vitamin A and Fe result ed in a better response of serum Fe and % TS than when the supplement consisted only of vitamin A or Fe alone . Vitamin A benefits hematological condition and Fe metabolism",
"BACKGROUND The coexistence of multiple micronutrient deficiencies is a widespread public health problem in many regions of the world . Interactions between zinc deficiency and vitamin A metabolism have been reported but no longitudinal studies have evaluated the effect of iron deficiency on vitamin A. OBJECTIVE The objective of this study was to investigate the effect of supplementation with iron , zinc , or both on vitamin A and its metabolically related proteins retinol binding protein ( RBP ) and transthyretin . DESIGN The study was a longitudinal , double-blind , placebo-controlled trial in which 219 rural Mexican children aged 18 - 36 mo were r and omly assigned to receive 20 mg Zn/d , 20 mg Fe/d , 20 mg Zn/d plus 20 mg Fe/d , or placebo . RESULTS Six months after supplementation , plasma retinol increased in all supplemented groups . Compared with placebo , zinc supplementation was associated with significantly higher plasma retinol and transthyretin but the increase in RBP was not significant . Iron supplementation significantly increased plasma retinol , RBP , and transthyretin . Supplementation with zinc plus iron significantly increased plasma retinol but not RBP or transthyretin . Children deficient in zinc , iron , or vitamin A ( as indicated by nutrient plasma concentration ) at the beginning of the study had a significantly greater increase in retinol than did children with adequate nutrient status . CONCLUSIONS Supplementation with zinc , iron , or both improved indicators of vitamin A status . The results of this study agree with previous observations of a metabolic interaction between zinc and vitamin A and suggest an interaction between iron and vitamin A metabolism",
"To evaluate the effect of long-term oral iron supplementation on growth , 250 children aged 6 - 71 mo were studied in a r and omized double-blind controlled trial . The intervention group received 125 mg of ferrous gluconate ( 15 mg elemental iron ) plus multivitamins ( vitamins A , D and C ) ; the comparison group received only multivitamins daily for 12 mo . Weight ( kg ) and height ( cm ) were measured every month . Eighty three percent of the children continued the treatment for one year . The weight increment over the 12-mo period was 1.35 + /- 0.65 kg ( mean + /- SD ) in the intervention group and 1.39 + /- 0.54 kg in the comparison group . The height increments were 6.01 + /- 1.47 and 6.18 + /- 1.58 cm in the intervention and comparison groups , respectively . Mean weight and height increments did not differ ; in an analysis stratified according to different age and nutritional categories , they also did not differ between the two groups , indicating that long-term iron supplementation does not increase growth in children",
"Whether children with malarial anaemia should receive supplementation with iron or folic acid is uncertain . Therefore , the effects of supplementary treatment with iron or folic acid , given together with chloroquine or pyrimethamine-sulfadoxine ( Fansidar ) , has been assessed in 600 Gambian children with uncomplicated falciparum malaria . After one month , haematological recovery was significantly better in the group treated with Fansidar than in the chloroquine-treated group ( difference in mean haemoglobin level = 0.54 g/dL , P = 0.01 ) . Children who received iron had a significantly better response than those given placebo ( differences in mean haemoglobin level after one month and at dry season follow-up = 0.70 g/dL , P = 0.006 , and 0.81 g/dL , P = 0.001 , respectively ) . Iron supplementation was not associated with increased prevalence of malaria . Supplementation with folic acid did not improve the haematological response but , among children who received Fansidar , the treatment failure rate was significantly higher among those given folic acid than among those given placebo . Thus , supplementation with iron , but not folic acid , improves haematological recovery without increasing susceptibility to malaria",
"The effect of long-term oral iron supplementation on morbidity due to diarrhea , dysentery and respiratory infections in 349 children , aged 2 - 48 mo , living in a poor community of Bangladesh , was evaluated in this double-blind study . The treatment group received 125 mg of ferrous gluconate ( 15 mg elemental iron ) plus multivitamins and the controls received only multivitamins , daily for 15 mo . House-to-house visits were made on alternate days by trained community health workers for recording symptoms and duration of illnesses and for monitoring medicine intake . Seventy-six percent of the children continued the syrup for over 1 y. No untoward effects were noticed in either treatment group . The attack rates for diarrhea , dysentery and acute respiratory tract infections ( ARI ) were 3 , 3 and 5 episodes per child per year , respectively . Each episode of diarrhea lasted a mean of 3 d , and those of dysentery and ARI , 5 d. The two treatment groups did not differ in the number of episodes , mean duration of each episode , or total days of illnesses due to diarrhea , dysentery and ARI . However , a 49 % greater number of episodes of dysentery was observed with iron supplementation in a subset of the study children who were less than 12 mo old ( P = 0.03 ) . The results of this study suggest that long-term oral iron supplementation is not harmful for older children in a poor community . Further studies are needed to demonstrate the safety and efficacy of iron administration in young infants",
"Objective : To assess the effects of iron and deworming on linear growth performance of preschoolers . Design : Three-month r and omized , double-blind and placebo-controlled trial . The children were allocated to four treatments : iron ( 60 mg elemental iron/day)+albendazole ( 200 mg/day for 3 consecutive days , repeated 1 month later ) , iron+albendazole-placebo , albendazole+iron-placebo or placebos . The supplementation was supervised . Subjects : A group of 177 children aged 3–5 y was selected from low-income households in a rural area in southern Bénin . A complete data set was analysed for 140 subjects . Many children were stunted ( 58 % had height-for-age Z-score measures : Anthropometric parameters , hemoglobin and eggs per gram feces . Results : No significant difference in changes in anthropometric parameters was observed between study groups , and also not in a sub- sample of stunted and anemic subjects . Changes in hemoglobin were highest in the iron-treated subjects at the end of the 3-month intervention period ( P=0.032 ) . The difference between the iron and the placebo groups remained significant even 7 months later ( P=0.022 ) . The difference was 5 g/l in both periods . Ascaris lumbricoides and hookworm infections decreased significantly in albendazole-treated subjects ( P children may have multiple micronutrient deficiencies . Therefore , it may be interesting to study appetite and food intake of young toddlers in relation to health and linear growth performance in poor environments . Sponsorship : The Nestlé Foundation ( Lausanne , Switzerl and ) .European Journal of Clinical Nutrition ( 2001 ) 55 ,",
"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",
"Objective : To examine effects of iron supplementation on vigilance , attention and conceptual learning in preschool children in Greece . Design : R and omized Double-Blind Placebo Controlled trial of iron . R and omization stratified by iron status and day care center ( DCC ) . Setting : Nine public DCCs in Athens , Greece . Subjects : In all , 49 3–4-y olds ( 21 anemic , 28 good iron status ) with birth weight not less than 2500 g , currently healthy ; benign past medical history , IQ ≥1 s.d . below the age-adjusted mean , serum Pb ≤200 ppb ( none exceeded 50 ppb ) , and height , weight and head circumference for age ≥10th percentile . Anemia defined as : ( 1 ) pretreatment Hgb Hgb rise of > 10 g/l ( T2–T0 ) with iron supplementation . Good iron status was defined as baseline levels of Hgb > 120 g/l and either TS > 20 % or serum ferritin > 12 μg/l . Intervention : The intervention consisted of a 2–month supplementation of 15 mg iron ( and MV ) vs placebo ( MV alone ) . Results : After iron treatment , the anemic subjects made significantly fewer errors of commission ( 14 % higher specificity , P higher accuracy ( P more efficient ( mean difference=1.09 , P given placebo . These effects of iron were not found among preschoolers with good iron status . No effects of iron treatment were found on the Oddity Learning task . Conclusions : This study demonstrated that iron supplementation of iron-deficient anemic preschoolers results in an improvement in discrimination , specifically selective attention . Sponsorship : University of California , Davis and Nutricia Corporation",
"Haematological and iron parameters , measured in 907 children aged from 6 months to 5 years in rural Gambia at the start of the rainy season , differed from those in American reference population s as follows : mean haemoglobin levels were much lower at ages 1 and 2 years and mean levels of mean corpuscular volume ( MCV ) were lower at all ages ( at age 1 year mean haemoglobin was 11.2 g/dl and mean MCV 68.2 fl ) ; in a sample of 249 children r and omly selected from the whole study population , mean serum iron levels were similar but mean transferrin saturation and mean serum ferritin levels were lower , especially at ages 1 - 3 years ( at age 1 year mean serum iron was 11.1 mumol/l , mean transferrin saturation 16.9 % , and geometric mean serum ferritin 8.8 ng/ml . A total of 213 children ( 23 % ) whose haemoglobin and mean corpuscular volume were both less than the 3rd percentile of the reference population received oral iron or placebo from their mothers during the rainy season when malaria transmission is maximal . Mean levels of haemoglobin , mean corpuscular volume , serum iron , transferrin saturation and serum ferritin rose in the iron-treated group and fell in the placebo group at all ages , except under 1 year for serum ferritin , to produce significant differences between the groups by the end of the study . Total iron-binding capacity showed no significant changes during the study . We concluded that oral iron given by the mother during the rainy season can be used to treat iron-deficiency anaemia in Gambian children who would otherwise become more anaemic",
"BACKGROUND Anaemia caused by iron deficiency is common in children younger than age 5 years in eastern Africa . However , there is concern that universal supplementation of children with iron and folic acid in areas of high malaria transmission might be harmful . METHODS We did a r and omised , placebo-controlled trial , of children aged 1 - 35 months and living in Pemba , Zanzibar . We assigned children to daily oral supplementation with : iron ( 12.5 mg ) and folic acid ( 50 mug ; n=7950 ) , iron , folic acid , and zinc ( n=8120 ) , or placebo ( n=8006 ) ; children aged 1 - 11 months received half the dose . Our primary endpoints were all-cause mortality and admission to hospital . Analyses were by intention to treat . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N59549825 . FINDINGS The iron and folic acid-containing groups of the trial were stopped early on Aug 19 , 2003 , on the recommendation of the data and safety monitoring board . To this date , 24 076 children contributed a follow-up of 25,524 child-years . Those who received iron and folic acid with or without zinc were 12 % ( 95 % CI 2 - 23 , p=0.02 ) more likely to die or need treatment in hospital for an adverse event and 11 % ( 1 - 23 % , p=0.03 ) more likely to be admitted to hospital ; there were also 15 % ( -7 to 41 , p=0.19 ) more deaths in these groups . INTERPRETATION Routine supplementation with iron and folic acid in preschool children in a population with high rates of malaria can result in an increased risk of severe illness and death . In the presence of an active programme to detect and treat malaria and other infections , iron-deficient and anaemic children can benefit from supplementation . However , supplementation of those who are not iron deficient might be harmful . As such , current guidelines for universal supplementation with iron and folic acid should be revised",
"Three studies conducted in Indonesia will be described . Soewondo ( 12 ) investigated the relation of iron deficiency and cognitive function and impact of iron supplementation on verbal intelligence , attention and concept learning among iron deficient children without anemia and iron deficient anemic children . Half of 176 children , aged 3 - 6 years , received elemental Fe for 8 weeks and the other half received placebo . There were significant changes from pre to post intervention evaluations in ferritin , transferrin saturation , free erythrocyte protoporphyrin , and hemoglobin in the iron deficient anemic children . Pre and post treatment psychological test data showed that iron deficiency anemia produced alterations in cognitive processes related to visual attention and concept acquisition . These alterations can be reversed with iron treatment . Idjradinata ( 4 ) assessed the impact of iron supplementation on iron deficient infant 's mental and psychomotor development . Hundred twenty six subjects aged 12 to 18 month were r and omly assigned to either iron treatment or placebo intervention . After 4 months of iron supplementation , the hemoglobin , ferritin and transferrin saturation changed significantly in the iron deficient infants . A developmental delay was observed in the iron deficient anemic infants before intervention and the conditions were reversed after 4 months of iron treatment . Soemiarti ( 8) examined the effectiveness of a training course given to mothers of children aged 12 to 24 month on the rearing environment and consequently to the child 's development . The subjects were 69 mothers of 20 - 35 years old . The training lasted for 21 days by giving mothers training using the program \" Ibu Maju Anak Bermutu \" . The rearing environment improved , also the child 's mental and psychomotor development",
"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 )",
"In rural Mexico and in many developing countries micronutrient deficiencies , growth stunting , and morbidity from infectious diseases are highly prevalent in young children . We assessed the extent to which growth stunting could be reversed and the number of infectious disease episodes reduced by zinc and /or iron supplementation . In a double-blind , r and omized community trial 219 Mexican preschoolers were supplemented with either 20 mg Zn as zinc methionine , 20 mg Fe as ferrous sulfate , 20 mg Zn + 20 mg Fe , or a placebo . After 12 mo , plasma zinc increased significantly in the two zinc-treated groups , and plasma ferritin was significantly higher in the two iron-treated groups . There was no effect of treatments on growth velocity or body composition . Children in both zinc-supplemented groups had fewer episodes of disease ( zinc alone , 3.9 + /- 0.3 ; zinc+iron , 3.7 + /- 0.4 ; placebo , 4.6 + /- 0.5 ; P diarrhea ( zinc alone , 0.7 + /- 0.1 ; zinc+iron , 0.8 + /- 0.1 ; placebo , 1.1 + /- 0.2 ; P Zinc and zinc+iron supplements reduced morbidity but had no effect on growth or body composition",
"OBJECTIVE To evaluate the prevalence of anemia , iron deficiency and iron deficiency anemia in a cohort of children . METHODS A cohort study nested in a r and omized field trial . Children were recruited at birth at the maternity unit of the only public hospital in the city of São Leopoldo , southern Brazil . This study assessed iron status ( hemoglobin and serum ferritin ) when children were 12 - 16 months old and later at the age of 3 - 4 years . Anemia was defined as hemoglobin concentration deficiency as serum ferritin deficiency anemia as hemoglobin concentration of anemia , iron deficiency and iron deficiency anemia was 63.7 , 90.3 and 58.8 % , respectively . The values for age group 3 - 4 years were 38.1 , 16.1 and 7.4 % , respectively . At age 12 - 16 months , 95 % of anemia cases were associated with iron deficiency against only 19.3 % of cases at age 3 - 4 years . CONCLUSIONS Iron deficiency was the main cause of anemia in the second year of life , but not at age 3 - 4 years . Thus , we point out that anemia in preschool children may have other causes and deserves careful assessment",
"In sub-Saharan countries , although malaria and malaria-associated anaemia are major public health problems , the usefulness of supplementary iron treatment for children with malaria-associated anaemia is unknown . In a 6-week period during the 1995 rainy season , 222 Malawian children aged or = 500 parasites/microliter blood and at least 5 g haemoglobin (HB)/dl blood and whose parents gave consent , were r and omized into a prospect i ve study comparing the efficacy of sulphadoxine- pyrimethamine only ( SP ) , SP plus daily iron ( SPD ) and SP plus weekly iron ( SPW ) as treatment for malaria-associated anaemia . The patients had their HB concentrations measured on enrollment ( day 0 ) , just before antimalarial treatment , and on days 3 , 7 , 14 , 21 and 28 ; 215 ( 96.8 % ) completed the 28-day study . Among the children with 5 - 8 g HB/dl on enrolment , HB gain by the end of the study was significantly greater than in the children with > 8 g HB/dl initially ( 4.1 v. 2.2 g/dl ; P gained significantly more HB by days 21 and 28 ( 3.6 and 4.9 g/dl , respectively ) than those in either the SPW ( 2.7 and 3.7 g/dl , respectively ) or the S2 groups ( 2.6 and 3.5 g/dl , respectively ) ; there was no difference in HB gain between the SP and SPW groups . Type of treatment had no apparent effect , at any time during the study , on HB gains in those patients who had > 8 g HB/dl on enrolment . Thus the children with 5 - 8 g HB/dl on enrolment benefited from daily iron therapy whereas those with > 8 g HB/dl derived no significant benefit ; improvement in HB depended most on whether enrolment HB was HB gains , irrespective of treatment group or HB concentration at enrolment , the anaemia observed may be mostly related to malaria . However , as a larger proportion of the iron-treated patients failed to clear their parasitaemias than of those given SP alone , oral iron may inhibit SP action . It is therefore recommended that , for children with both malaria and malaria-associated anaemia , the malaria should first be cleared with an effective antimalarial drug , such as SP , before the anaemia , if it still persists , is treated with iron",
"1 . The effect of daily supplements of 20 - 30 mg inorganic iron as ferrous sulphate on the growth , activity and haematological status of preschool children was studied for 3.5 , 7 and 12 months and compared to that of children who served as controls . All children were given their daily requirements of energy and protein . In addition , they received 5 microgram cyanocobalamin and 200 microgram folic acid . 2 . Fe supplementation increased the haemoglobin , serum Fe and percentage saturation of transferrin and reduced the unsaturated Fe-binding capacity significantly compared to corresponding values for the controls . 3 . Height and activity were unaffected by Fe supplements . 4 . Of the children 45 % had haemoglobin values below 110 g/l at the end of 7 - 12 months of Fe supplementation",
"Iron deficiency anemia ( IDA ) remains the most prevalent nutritional deficiency in infants worldwide . The purpose of this study was to determine the efficacy of daily and weekly iron supplementation for 3 months to improve the iron status in 4-month-old , exclusively breast-fed healthy infants . Infants 4 months of age were eligible for the open , r and omized controlled trial if their mothers intended to continue exclusive breast-feeding until the infants were 6 months of age . Infants or mothers with iron deficiency ( ID ) or IDA on admission were excluded . The infants ( n = 79 ) were r and omly assigned to three groups , the first group receiving daily ( 1 mg/kg daily ) , the second group weekly ( 7 mg/kg weekly ) , and the third group no iron supplementation . Anthropometric measurements were taken on admission and at 6 and 7 months of age . Iron status was analyzed on admission and monthly for 3 months . Both hematologic parameters and anthropometric measurements were found to be similar among the three groups during the study period . Seven infants ( 31.8 % ) in the control group , six ( 26.0 % ) in the daily group , and three ( 13.6 % ) in the weekly group developed ID or IDA ( P > 0.05 ) . Infants whose mothers had ID or IDA during the study period were more likely to develop ID or IDA independently from iron supplementation . Serum ferritin levels decreased between 4 and 6 months of age in the control and daily groups ; the weekly group showed no such decrease . In all groups , the mean levels of serum ferritin were significantly increased from 6 months to 7 months of age during the weaning period . In this study , which had a limited number of cases , weekly or daily iron supplementation was not found to decrease the likelihood of IDA . In conclusion , exclusively breast-fed infants with maternal IDA appeared to be at increased risk of developing IDA",
"The growth status of anemic ( n = 117 , Hb 7 - 10 g/dl ) and normal ( n = 53 , H > or = 11 g/dl ) children 3 - 5 years of age living under similar environmental and socio-economic conditions was evaluated . The dietary intake was assessed on a r and om sub sample of the anemic and normal children . The anemic children had a poorer growth status than normal children as indicated by their significantly ( p weight , height and weight for age and significantly ( p Iron supplementation ( 40 mg elemental iron/day ) for six months produced a significant ( p Hb levels of both groups ( 1.6 g/dl in the anemic and 0.8 g/dl in the non-anemic ) compared to their respective controls who received sugar placebos . The growth performance of the anemic children supplemented with iron was superior to that of anemic placebo treated children as indicated by a better weight gain and a significantly higher weight for height ( p Weight for age was a good differentiator of the anemic from normal while weight for height was a good indicator of the impact of iron supplements on growth",
"Concern has been raised that iron supplementation for treatment of acute malaria may worsen the severity of malaria . We compared the effect of iron and folate with folate alone on hematologic recovery in children treated for acute malaria . We r and omized 82 children 6 - 60 months of age from Nigeria with smear-positive malaria and anemia ( hematocrit to receive iron ( 2 mg/kg/day ) plus folate ( 5 mg/day ) or folate alone in addition to antimalarial drugs . The mean ± SD hematocrit at baseline was 28.5 % ± 2.9 % . At four weeks , the mean hematocrit increased by 2.5 % ± 1.6 % in the iron plus folate group and by 1.4 % ± 1.0 % in the folate alone group ( P = 0.001 ) . Baseline hematocrit , iron supplementation , weight for height , and weekly meat intake were significant predictors of final hematocrit . The effect of iron was not significantly modified by baseline hematocrit , weekly meat intake , nutritional status , mother 's education , sex , or age of the child . Iron supplementation improved hematologic recovery in children with malarial anemia"
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Background Awareness of the magnitude of contact sports-related concussions has risen exponentially in recent years . Our objective is to conduct a prospect ively registered systematic review of the scientific evidence regarding interventions to prevent contact sports-related concussions . Methods Using the Grading of Recommendations Assessment , Development , and Evaluation methodology , we performed a systematic review of the literature to answer seven population , intervention , comparator , and outcomes ( PICO ) questions regarding concussion education , head protective equipment , rules prohibiting high-risk activity and neck strengthening exercise for prevention of contact sports-related concussion in pediatric and adult amateur athletes . A query of MEDLINE , PubMed , Scopus , Cumulative Index of Nursing and Allied Health Literature , and Embase was performed . Letters to the editor , case reports , book chapters , and review articles were excluded , and all articles review ed were written in English . Results Thirty-one studies met the inclusion criteria and were applicable to our PICO questions . Conditional recommendations are made supporting preventive interventions concussion education and rules prohibiting high-risk activity for both pediatric and adult amateur athletes and neck strengthening exercise in adult amateur athletes . Strong recommendations are supported for head protective equipment in both pediatric and adult amateur athletes . Strong recommendations regarding newer football helmet technology in adult amateur athletes and rules governing the implementation of body-checking in youth ice hockey are supported . Conclusion Despite increasing scientific attention to sports-related concussion , studies evaluating preventive interventions remain relatively sparse . This systematic review serves as a call to focus research on primary prevention strategies for sports-related concussion . Level of evidence IV . PROSPERO registration number # 42016043019
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"Objective : The ThinkFirst Canada Smart Hockey program is an educational injury prevention video that teaches the mechanisms , consequences , and prevention of brain and spinal cord injury in ice hockey . This study evaluates knowledge transfer and behavioural outcomes in 11–12 year old hockey players who viewed the video . Design : R and omized controlled design . Setting : Greater Toronto Minor Hockey League , Toronto Ontario . Subjects : Minor , competitive 11–12 year old male ice hockey players and hockey team coaches . Interventions : The Smart Hockey video was shown to experimental teams at mid-season . An interview was conducted with coaches to underst and reasons to accept or refuse the injury prevention video . Main outcome measures : A test of concussion knowledge was administered before , immediately after , and three months after exposure to the video . The incidence of aggressive penalties was measured before and after viewing the video . Results : The number of causes and mechanisms of concussion named by players increased from 1.13 to 2.47 and from 0.67 to 1.22 respectively . This effect was maintained at three months . There was no significant change in control teams . There was no significant change in total penalties after video exposure ; however , specific body checking related penalties were significantly reduced in the experimental group . Conclusion : This study showed some improvements in knowledge and behaviours after a single viewing of a video ; however , these findings require confirmation with a larger sample to underst and the sociobehavioural aspects of sport that determine the effectiveness and acceptance of injury prevention interventions",
"Background : In a previous prospect i ve study , the risk of concussion and all injury was more than threefold higher among Pee Wee ice hockey players ( ages 11–12 years ) in a league that allows bodychecking than among those in a league that does not . We examined whether two years of bodychecking experience in Pee Wee influenced the risk of concussion and other injury among players in a Bantam league ( ages 13–14 ) compared with Bantam players introduced to bodychecking for the first time at age 13 . Methods : We conducted a prospect i ve cohort study involving hockey players aged 13–14 years in the top 30 % of divisions of play in their leagues . Sixty-eight teams from the province of Alberta ( n = 995 ) , whose players had two years of bodychecking experience in Pee Wee , and 62 teams from the province of Quebec ( n = 976 ) , whose players had no bodychecking experience in Pee Wee , participated . We estimated incidence rate ratios ( IRRs ) for injury and for concussion . Results : There were 272 injuries ( 51 concussions ) among the Bantam hockey players who had bodychecking experience in Pee Wee and 244 injuries ( 49 concussions ) among those without such experience . The adjusted IRRs for game-related injuries and concussion overall between players with bodychecking experience in Pee Wee and those without it were as follows : injury overall 0.85 ( 95 % confidence interval [ CI ] 0.63 to 1.16 ) ; concussion overall 0.84 ( 95 % CI 0.48 to 1.48 ) ; and injury result ing in more than seven days of time loss ( i.e. , time between injury and return to play ) 0.67 ( 95 % CI 0.46 to 0.99 ) . The unadjusted IRR for concussion result ing in more than 10 days of time loss was 0.60 ( 95 % CI 0.26 to 1.41 ) . Interpretation : The risk of injury result ing in more than seven days of time loss from play was reduced by 33 % among Bantam hockey players in a league where bodychecking was allowed two years earlier in Pee Wee compared with Bantam players introduced to bodychecking for the first time at age 13 . In light of the increased risk of concussion and other injury among Pee Wee players in a league where bodychecking is permitted , policy regarding the age at which hockey players are introduced to bodychecking requires further consideration",
"Objective : To identify specific risk factors for concussion severity among ice hockey players wearing full face shields compared with half face shields ( visors ) . Methods : A prospect i ve cohort study was conducted during one varsity hockey season ( 1997–1998 ) with 642 male ice hockey players ( median age 22 years ) from 22 teams participating in the Canadian Inter-University Athletics Union . Half of the teams wore full face shields , and half wore half shields ( visors ) for every practice and game throughout the season . Team therapists and doctors recorded on structured forms daily injury , participation , and information on face shield use for each athlete . The main outcome measure was any traumatic brain injury requiring assessment or treatment by a team therapist or doctor , categorised by time lost from subsequent participation and compared by type of face shield worn . Results : Players who wore half face shields missed significantly more practice s and games per concussion ( 2.4 times ) than players who wore full face shields ( 4.07 sessions ( 95 % confidence interval ( CI ) 3.48 to 4.74 ) v 1.71 sessions ( 95 % CI 1.32 to 2.18 ) respectively ) . Significantly more playing time was lost by players wearing half shields during practice s and games , and did not depend on whether the athletes were forwards or defence , rookies or veterans , or whether the concussions were new or recurrent . In addition , players who wore half face shields and no mouthguards at the time of concussion missed significantly more playing time ( 5.57 sessions per concussion ; 95 % CI 4.40 to 6.95 ) than players who wore half shields and mouthguards ( 2.76 sessions per concussion ; 95 % CI 2.14 to 3.55 ) . Players who wore full face shields and mouthguards at the time of concussion lost no playing time compared with 1.80 sessions lost per concussion ( 95 % CI 1.38 to 2.34 ) for players wearing full face shields and no mouthguards . Conclusions : The use of a full face shield compared with half face shield by intercollegiate ice hockey players significantly reduced the playing time lost because of concussion , suggesting that concussion severity may be reduced by the use of a full face shield",
"BACKGROUND Concussion is a serious problem in many contact sports , including rugby union football . The study 's primary aim was to measure the efficacy of padded headgear in reducing the rates of head injury or concussion . METHODS A cluster r and omized controlled trial with three arms was conducted with rugby union football teams as the unit of r and omization . Teams consisted of males participating in under 13- , 15- , 18- , and 20-yr age group competitions . The interventions were \" st and ard \" and \" modified \" padded headgear . Headgear wearing and injury were measured for each study team at each game over two seasons . RESULTS Eighty-two teams participated in year 1 and 87 in year 2 . A total of 1493 participants ( 10,040 player hours ) were in the control group , 1128 participants ( 8170 player hours ) were assigned to the st and ard headgear group , and 1474 participants ( 10,650 player hours ) were assigned to the modified headgear group . The compliance rates were low in all groups , but 46 % of participants wore st and ard headgear . An intention-to-treat analysis showed no differences in the rates of head injury or concussion between controls and headgear arms . Incidence rate ratios for st and ard headgear wearers referenced to controls were 0.95 and 1.02 for game and missed game injuries . Analyses of injury rates based on observed wearing patterns also showed no significant differences . Incidence rate ratios for st and ard headgear wearers referenced to nonwearers were 1.11 and 1.10 for game and missed game injuries . CONCLUSIONS Padded headgear does not reduce the rate of head injury or concussion . The low compliance rates are a limitation . Although individuals may choose to wear padded headgear , the routine or m and atory use of protective headgear can not be recommended",
"Objective —To determine whether protective headgear reduced the incidence of concussion in a pilot study of under 15 rugby union . Methods —Sixteen under 15 rugby union teams were recruited from three interschool competitions in metropolitan Sydney and the adjacent country region . A prospect i ve study was undertaken over a single competitive season . The study had two arms : a headgear arm and a control arm . Headgear wearing rates and injury data were reported to the investigators and verified using spot checks . Results —A total of 294 players participated in the study . There were 1179 player exposures with headgear and 357 without headgear . In the study time frame , there were nine incidences of concussion ; seven of the players involved wore headgear and two did not . There was no significant difference between concussion rates between the two study arms . Conclusions —Although there is some controversy about the desirability of wearing protective headgear in football , this pilot study strongly suggests that current headgear does not provide significant protection against concussion in rugby union at a junior level",
"BACKGROUND : Each year , in the United states , approximately 900 persons die from injuries due to bicycle crashes and over 500,000 persons are treated in emergency departments . Head injury is by far the greatest risk posed to bicyclists , comprising one-third of emergency department visits , two-thirds of hospital admissions , and three-fourths of deaths . Facial injuries to cyclists occur at a rate nearly identical to that of head injuries . Although it makes inherent sense that helmets would be protective against head injury , establishing the real-world effectiveness of helmets is important . A number of case-control studies have been conducted demonstrating the effectiveness of bicycle helmets . Because of the magnitude of the problem and the potential effectiveness of bicycle helmets , the objective of this review is to determine whether bicycle helmets reduce head , brain and facial injury for bicyclists of all ages involved in a bicycle crash or fall . OBJECTIVES : To determine whether bicycle helmets reduce head , brain and facial injury for bicyclists of all ages involved in a bicycle crash or fall . SEARCH STRATEGY : We search ed The Cochrane Controlled Trials Register , MEDLINE , EMBASE , Sport , ERIC , NTIS , Exp and ed Academic Index , CINAHL , PsycINFO , Occupational Safety and Health , and Dissertations Abstract s. We checked reference lists of past review s and review articles , studies from government agencies in the United States , Europe and Australia , and contacted colleagues from the International Society for Child and Adolescent Injury Prevention , World Injury Network , CDC funded Injury Control and Research Centers , and staff in injury research agencies around the world . SELECTION CRITERIA : Controlled studies that evaluated the effect of helmet use in a population of bicyclists who had experienced a crash . We required that studies have complete outcome ascertainment , accurate exposure measurement , appropriate selection of the comparison group and elimination or control of factors such as selection bias , observation bias and confounding . DATA COLLECTION AND ANALYSIS : Five published studies met the selection criteria . Two abstract ors using a st and ard abstract ion form independently abstract ed data . Odds ratios with 95 % CI were calculated for the protective effect of helmet for head and facial injuries . Study results are presented individually . Head and brain injury results were also summarized using meta- analysis techniques . MAIN RESULTS : No r and omized controlled trials were found . This review identified five well conducted case control studies which met our selection criteria . Helmets provide a 63%-88 % reduction in the risk of head , brain and severe brain injury for all ages of bicyclists . Helmets provide equal levels of protection for crashes involving motor vehicles ( 69 % ) and crashes from all other causes ( 68 % ) . Injuries to the upper and mid facial areas are reduced 65 % . REVIEW ER 'S CONCLUSIONS : Helmets reduce bicycle-related head and facial injuries for bicyclists of all ages involved in all types of crashes including those involving motor vehicles ",
"Objective : To evaluate the effect of cervical muscle strength on head impact biomechanics . Design : Prospect i ve cohort . Setting : Field setting . Participants : Thirty-seven volunteer ice hockey players ( age = 15.0 ± 1.0 years , height = 173.5 ± 6.2 cm , mass = 66.6 ± 9.0 kg , playing experience = 2.9 ± 3.7 years ) . Interventions : Participants were equipped with accelerometer-instrumented helmets to collect head impact biomechanics ( linear and rotational acceleration ) throughout an entire playing season . Before the season , isometric cervical muscle strength was measured for the anterior neck flexors , anterolateral neck flexors , cervical rotators , posterolateral neck extensors , and upper trapezius . Data were analyzed using r and om intercept general mixed linear models , with each individual player as a repeating factor/cluster . Main Outcome Measures : Dependent variables included linear and rotational head accelerations . Cervical strength data were categorized into tertiles , creating groups with high , moderate , and low strength . Strength measures were averaged and normalized to body mass . Results : Significant differences in cervical muscle strength existed across our strength groups ( P in linear or rotational acceleration across strength groups for the anterior neck flexors ( PLin = 0.399 ; PRot = 0.060 ) , anterolateral neck flexors ( PLin = 0.987 ; PRot = 0.579 ) , cervical rotators ( PLin = 0.136 ; PRot = 0.238 ) , posterolateral neck extensors ( PLin = 0.883 ; PRot = 0.101 ) , or upper trapezius ( PLin = 0.892 ; PRot = 0.689 ) . Conclusions : Our hypothesis that players with greater static neck strength would experience lower result ant head accelerations was not supported . This contradicts the notion that cervical muscle strength mitigates head impact acceleration . Because we evaluated cervical strength isometrically , future studies should consider dynamic ( ie , isokinetic ) methods in the context of head impact biomechanics",
"OBJECTIVE : The purpose of this study was to compare concussion rates and recovery times for athletes wearing newer helmet technology compared to traditional helmet design . METHODS : This was a three-year , prospect i ve , naturalistic , cohort study . Participants were 2,141 high school athletes from Western Pennsylvania . Approximately half of the sample wore the Revolution helmet manufactured by Riddell , Inc. ( n = 1,173 ) and the remainder of the sample used st and ard helmets ( n = 968 ) . Athletes underwent computerized neurocognitive testing through the use of ImPACT at the beginning of the study . Following a concussion , players were reevaluated at various time intervals until recovery was complete . RESULTS : In the total sample , the concussion rate in athletes wearing the Revolution was 5.3 % and in athletes wearing st and ard helmets was 7.6 % [ & khgr;2 ( 1 , 2 , 141 ) = 4.96 , P relative risk estimate was 0.69 ( 95 % confidence interval = 0.499– 0.958 ) . Wearing the Revolution helmet was associated with approximately a 31 % decreased relative risk and 2.3 % decreased absolute risk for sustaining a concussion in this cohort study . The athletes wearing the Revolution did not differ from athletes wearing st and ard helmets on the mechanism of injury ( e.g. , head-to-head strike ) , on-field concussion markers ( e.g. , amnesia or loss of consciousness ) , or on-field presentation of symptoms ( e.g. , headaches , dizziness , or balance problems ) . CONCLUSION : Recent sophisticated laboratory research has better eluci date d injury biomechanics associated with concussion in professional football players . This data has led to changes in helmet design and new helmet technology , which appears to have beneficial effects in reducing the incidence of cerebral concussion in high school football players",
"Background / aim To determine if Boys Bantam and Peewee and Girls U14 sustain fewer concussions , head hits , ‘ other injuries ’ and penalties in hockey tournaments governed by intensified fair play ( IFP ) than non-intensified fair play ( NIFP ) . Methods A prospect i ve comparison of IFP , a behaviour modification programme that promotes sportsmanship , versus control ( non-intensified , NIFP ) effects on numbers of diagnosed concussions , head hits without diagnosed concussion ( HHWDC ) , ‘ other injuries ’ , number of penalties and fair play points ( FPPs ) . 1514 players , ages 11–14 years , in 6 IFP ( N=950 ) and 5 NIFP ( N=564 ) tournaments were studied . Results Two diagnosed concussions , four HHWDC , and six ‘ other injuries ’ occurred in IFP tournaments compared to one concussion , eight HHWDC and five ‘ other injuries ’ in NIFP . There were significantly fewer HHWDC in IFP than NIFP ( p=0.018 ) . However , diagnosed concussions , ‘ other injuries ’ , penalties and FPPs did not differ significantly between conditions . In IFP , a minority of teams forfeited the majority of FPPs . Most diagnosed concussions , HHWDC , and other injuries occurred to Bantam B players and usually in penalised teams that forfeited their FPPs . Conclusions In response to significant differences in HHWDC between IFP and NIFP tournaments , the following considerations are encouraged : m and atory implementation of fair play in regular season and tournaments , empowering tournament directors to not accept heavily penalised teams , and introducing ‘ no body checking ’ in Bantam",
"CONTEXT Speculation exists that use of a full face shield by ice hockey players may increase their risk of concussions and neck injuries , off setting the benefits of protection from dental , facial , and ocular injuries , but , to our knowledge , no data exist regarding this possibility . OBJECTIVE To determine the risk of sustaining a head or neck injury among intercollegiate ice hockey players wearing full face shields compared with those wearing half shields . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study conducted during the 1997 - 1998 Canadian Inter-University Athletics Union hockey season of 642 male hockey players ( mean age , 22 years ) from 22 teams . Athletes from 11 teams wore full face shields and athletes from 11 teams wore half face shields during play . MAIN OUTCOME MEASURE Reportable injury , defined as any event requiring assessment or treatment by a team therapist or physician or any mild traumatic brain injury or brachial plexus stretch , categorized by time lost from subsequent participation and compared by type of face shield . RESULTS Of 319 athletes who wore full face shields , 195 ( 61.6 % ) had at least 1 injury during the study season , whereas of 323 who wore half face shields , 204 ( 63.2 % ) were injured . The risk of sustaining a facial laceration and dental injury was 2.31 ( 95 % confidence interval [ CI ] , 1.53 - 3.48 ; P half vs full face shields . No statistically significant risk differences were found for neck injuries , concussion , or other injuries , although time lost from participation because of concussion was significantly greater in the half shield group ( P full shields . CONCLUSIONS These data provide evidence that the use of full face shields is associated with significantly reduced risk of sustaining facial and dental injuries without an increase in the risk of neck injuries , concussions , or other injuries",
"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 With the heightened awareness of concussions in all sports , the development and implementation of effective prevention strategies are necessary . Education has been advocated as an effective injury prevention intervention . Purpose To examine the effectiveness of the ‘ Smart Hockey : More Safety , More Fun ’ video on knowledge transfer among minor league hockey players . Study Design Cluster-r and omised controlled trial . Methods A total of 267 participants from two age divisions and competitive levels were assigned to either a video or no-video group . The video was shown ( or not shown ) to the entire team as a result of r and om assignment . To evaluate the effectiveness of the educational video , question naires specific to concussion knowledge and players ’ attitudes and behaviours were completed . Results There was a significant increase in the players ’ concussion knowledge scores immediately following exposure to the video ( F(1,103)=27.00 , p concussion knowledge at 2 months was not significantly different between the video and no-video groups , after controlling for prior knowledge level , age and competitive level ( F(1,115)=0.41 , p=0.523 ) . Similarly , players ’ attitudes and behaviour scores at 2 months did not differ between groups ( F(1,115)=0.41 , p=0.507 ) . Conclusions We were able to show that a single viewing of an educational video in hockey could immediately improve knowledge about concussion but that this effect was transient and lost at 2-month follow-up . Future prevention endeavours in hockey and other sports should attempt to incorporate strategies and modalities to enhance knowledge retention ",
"This study investigated the incidence of injury in sub-elite Rugby League players before and after the introduction of the limited interchange rule . The incidence of injury was prospect ively studied in one sub-elite Rugby League club over three competitive seasons . Two seasons were played under the unlimited interchange rule , while the third season was played under the limited interchange rule . Players participated in 91 matches under the unlimited interchange rule and 44 matches under the limited interchange rule . Injury was defined as any pain , disability or injury that occurred as a result of a competition game that caused the player to miss a subsequent game . The relative risk ( RR ) of injury significantly decreased ( RR = 0.70 [ 0.65 to 0.75 ] , P limited interchange rule , with the incidence of injury decreasing from 72.5 ( 58.2 to 86.8 ) per 1000 playing hr under the unlimited interchange rule to 51.0 ( 33.8 to 68.1 ) per 1000 playing hr under the limited interchange rule . The risk of sustaining thigh and calf injuries ( RR= 0.27 [ 0.12 to 0.59 ] , P , muscular strains ( RR= 0.23 10.17 to 0.31 ] . , P , and high intensity running injuries ( RR= 0.16 [ 0.04 to 0.691 , P limited interchange rule . These findings demonstrate that the risk of injury in sub-elite Rugby League players is significantly reduced following the introduction of the limited interchange rule . The reduced injury risk may reflect a fatigue-induced reduction in match speed and impact forces associated with physical collisions and tackles",
"CONTEXT Ice hockey has one of the highest sport participation and injury rates in youth in Canada . Body checking is the predominant mechanism of injury in leagues in which it is permitted . OBJECTIVE To determine if risk of injury and concussion differ for Pee Wee ( ages 11 - 12 years ) ice hockey players in a league in which body checking is permitted ( Alberta , Canada ) vs a league in which body checking is not permitted ( Quebec , Canada ) . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study conducted in Alberta and Quebec during the 2007 - 2008 Pee Wee ice hockey season . Participants ( N = 2154 ) were players from teams in the top 60 % of divisions of play . MAIN OUTCOME MEASURES Incidence rate ratios adjusted for cluster based on Poisson regression for game- and practice -related injury and concussion . RESULTS Seventy-four Pee Wee teams from Alberta ( n = 1108 players ) and 76 Pee Wee teams from Quebec ( n = 1046 players ) completed the study . In total , there were 241 injuries ( 78 concussions ) reported in Alberta ( 85 077 exposure-hours ) and 91 injuries ( 23 concussions ) reported in Quebec ( 82 099 exposure-hours ) . For game-related injuries , the Alberta vs Quebec incidence rate ratio was 3.26 ( 95 % confidence interval [ CI ] , 2.31 - 4.60 [ n = 209 and n = 70 for Alberta and Quebec , respectively ] ) for all injuries , 3.88 ( 95 % CI , 1.91 - 7.89 [ n = 73 and n = 20 ] ) for concussion , 3.30 ( 95 % CI , 1.77 - 6.17 [ n = 51 and n = 16 ] ) for severe injury ( time loss , > 7 days ) , and 3.61 ( 95 % CI , 1.16 - 11.23 [ n=14 and n=4 ] ) for severe concussion ( time loss , > 10 days ) . The estimated absolute risk reduction ( injuries per 1000 player-hours ) that would be achieved if body checking were not permitted in Alberta was 2.84 ( 95 % CI , 2.18 - 3.49 ) for all game-related injuries , 0.72 ( 95 % CI , 0.40 - 1.04 ) for severe injuries , 1.08 ( 95 % CI , 0.70 - 1.46 ) for concussion , and 0.20 ( 95 % CI , 0.04 - 0.37 ) for severe concussion . There was no difference between provinces for practice -related injuries . CONCLUSION Among 11- to 12-year-old ice hockey players , playing in a league in which body checking is permitted compared with playing in a league in which body checking is not permitted was associated with a 3-fold increased risk of all game-related injuries and the categories of concussion , severe injury , and severe concussion",
"OBJECTIVE To determine the rate , type , and severity of injuries incurred and penalties assessed during the qualifying fair-play ( points for playing without excessive penalties ) and championship \" regular \" rules ( winner advances ) portions of a 1994 Junior Gold ice hockey tournament . DESIGN A prospect i ve evaluation of injuries by certified athletic trainers at the tournament site . SETTING A community-organized , 3-day , 31-game tournament in Minnesota . PARTICIPANTS Two hundred seventy-three male players , younger than 20 years and in high school . MEASUREMENTS /MAIN RESULTS Injuries were recorded by an on-site certified athletic trainer , and the penalties were tallied from the score sheets . The injury rates for the total number of injuries were 26.4 injuries per 1000 athlete exposures and 273.8 injuries per 1000 player hours . When only notable injuries ( concussion , facial laceration , or moderate level of severity and above ) were considered , the injury rates were 10 per 1000 athlete exposures and 103.9 per 1000 player hours . The ratio of notable fair-play to notable regular-rules injuries was 1:4.8 . The number of penalties assessed per game averaged 7.1 penalties during fair-play rules and 13 penalties during the regular-rules competition . Penalties related to rough play and injury occurred four times more frequently during games with regular rules than those with fair-play rules . CONCLUSIONS The fair-play concept can reduce injury rates , penalty rates , and severity of penalties and should be considered for ice hockey at all levels of play . The fair-play concept could be applied to other contact sports to reduce injury rates and rules infractions"
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Background and Aim Extensive epidemiological evidence suggests that nonalcoholic fatty liver disease ( NAFLD ) is the primary chronic liver disease worldwide . However , some studies have showed conflicting results on the effects of probiotics and synbiotics supplementation . Therefore , we conducted a systematic review and meta- analysis to investigate the effectiveness of the supplementation in subjects with NAFLD . Methods We search ed systematic ally PubMed , Cochrane , and Embase data bases up to April 2018 and checked manually the bibliography of the original articles . The quality of the studies was evaluated using the Cochrane Risk of Bias Tool . Results This study analyzed 15 r and omized , controlled trials involving 782 patients with NAFLD . Probiotics and synbiotics supplementation could significantly improve liver steatosis , alanine aminotransferase , aspartate aminotransferase , triglyceride , total cholesterol , high-density lipoprotein , low-density lipoprotein , homeostasis model assessment -insulin resistance , liver stiffness and tumor necrosis factor-alpha ( all P ameliorate body mass index ( mean difference [ MD ] = −0.00 ; 95 % confidence interval [ CI ] : −0.22 to 0.22 , P = 0.99 ) , waist circumference ( MD = −0.01 ; 95 % CI −0.03 to 0.02 , P = 0.57 ) and fasting blood sugar ( st and ard mean difference [ SMD ] = −0.10 ; 95 % CI −0.32 to 0.12 , P = 0.39 ) . Conclusion We present clear evidence for the benefit of probiotics and synbiotics supplementation for liver steatosis , liver enzymes , lipid profiles and liver stiffness in patients with NAFLD
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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 According to previous studies , probiotic and prebiotic supplementation have desirable effects on glycemic parameters . Thus far , the effect of supplementation on the glycemic parameters and adipokines in non-alcoholic fatty liver disease ( NAFLD ) has not been assessed . Therefore , the aim of this study was to determine the effects of supplementation with probiotic and prebiotic on adiokines and glycemic parameters in the patients with NAFLD . METHODS In the present r and omized , double-blind , placebo-controlled trial , 89 patients with NAFLD were r and omly divided into three groups to receive one probiotic capsule + 16 g/d maltodextrin ( probiotic group ) or 16 g/d oligofructose powder + one placebo capsule ( prebiotic group ) , and one placebo capsule + 16 g/d maltodextrin ( control group ) for 12 weeks . All the subjects in the study were advised to follow the weight loss diet and physical activity recommendations during the intervention . Fasting blood sample s were taken at baseline and after the intervention to measure leptin , adiponectin , insulin , and fasting blood sugar . RESULTS At the end of the study , serum concentrations of leptin , insulin , and HOMA-IR decreased significantly in the probiotic and prebiotic groups compared with the control group . Despite the changes within the groups , serum concentrations of adiponectin did not change significantly between the three groups . Also , fasting blood sugar did not change between the groups , but decreased in the prebiotic group . Quantitative insulin-sensitivity check index ( QUICKI ) increased significantly in probiotic and prebiotic groups compared with the control group . CONCLUSION Probiotic and prebiotic supplementation along with lifestyle intervention has a favorable impact on glycemic parameters and leptin levels compared with lifestyle intervention alone",
"Objective : To study the clinical effect of probiotics in the treatment of non-alcoholic fatty liver disease ( NAFLD ) . Methods : A total of 200 patients with NAFLD were r and omly divided into 4 groups : control group ( routine treatment group ) and combined treatment group A , B and C. Each group had equal patients . The control group received orally polyene phosphatidylcholine capsules ; whereas combined group A , B and C were given orally the live \" combined Bifidobacterium Lactobacillus and Enterococcus powder \" , \" two live combined Bacillus subtilis and Enterococcus \" , and the both probiotics respectively . The duration of treatment was 1 month . Laboratory parameters were evaluated before treatment and thirtieth day after treatment , including cholesterol ( TC ) , triglyceride ( TG ) , high density lipoprotein cholesterol ( HDL-C ) , low density lipoprotein cholesterol(LDL-C ) , alanine aminotransferase(ALT ) , aspartate aminotransferase ( AST ) , fasting blood glucose ( FPG ) , serum high molecular weight adiponectin ( HMW-APN ) and serum TNFα . Meanwhile the faece sample was collected for routine test and bacterial culture . Liver ultrasound scan was done in all patients . Results : In terms of blood lipids and blood glucose , each group improved after treatment with significant differences ( P for liver function , serum ALT and AST decreased after treatment in each group ; especially in combined group C which were lower than those of control group [ ( 33.7±7.6 ) U/L vs. ( 45.0±8.5 ) U/L ; ( 22.0±1.6 ) U/L vs. ( 29.4±3.7 ) U/L ; P decreased after treatment in each group , in addition the values in combined group C was significantly lower than that of control group[(0.51±0.27 ) µg/L vs. ( 0.82±0.28 ) µg/L , P increased after treatment in each group , and the HMW-APN in combined C group was significantly higher than that of control group[(9.28±3.72 ) µg/L vs. (7.87±3.96)µg/L , P of fatty liver by ultrasound , but the difference between groups was not statistically significant . ( 6 ) Compared with before treatment , fecal flora in combined groups was all reduced ( P improve intestinal microecological system in NAFLD patients via inhibiting TNFα and enhancing adiponectin , possibly result ing in regulating blood glucose , lipid metabolism , and protecting liver injury from NAFLD",
"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",
"Diabetic nephropathy ( DN ) is one the most important complications of diabetes leading to end-stage renal disease . Dietary approaches have been considered to control of the kidney function deterioration among these patients . The aim of the present study was to determine the effects of fortified soy milk with Lactobacillus plantarum A7 on renal function biomarkers in type 2 DN patients . Forty-eight DN subjects were attended to this parallel r and omized trial study . Participants were r and omly assigned to consume a diet containing 200 mL/day probiotic soy milk in intervention group or soy milk in the control condition for 8 weeks . An inflammatory adipokine — Progranulin ( PGRN ) , a cytokine receptor-soluble tumor necrosis factor receptor 1 ( sTNFR1 ) , and serum levels of Neutrophil gelatinase-associated lipocalin ( NGAL ) and cystatin C ( Cys-C ) as the new renal function biomarkers were measured after 8 weeks of intervention according to the st and ard protocol . Our analysis showed that consumption of probiotic soy milk result ed in a significant reduction in the Cys-C and PGRN levels compared with the soy milk ( P = 0.01 ) in the final adjusted model . In addition , after adjustment for age , weight , and energy intake , a marginally significant in the NGAL level was seen between two groups ( P = 0.05 ) . However , there was no significant differences on the sTNFR1concenteration between two groups ( P = 0.06 ) . Overall , intake of probiotic soy milk may have a beneficial effect on the renal function in patients with DN",
"BACKGROUND Nonalcoholic fatty liver disease ( NAFLD ) is the most common chronic liver disease in the world . Oral administration of synbiotic has been proposed as an effective treatment of NAFLD because of its modulating effect on the gut flora , which can influence the gut-liver axis . OBJECTIVE The objective was to evaluate the effects of supplementation with synbiotic on hepatic fibrosis , liver enzymes , and inflammatory markers in patients with NAFLD . DESIGN In a r and omized , double-blind , placebo-controlled clinical trial conducted as a pilot study , 52 patients with NAFLD were supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule . Both groups were advised to follow an energy-balanced diet and physical activity recommendations . RESULTS At the end of the study , the alanine aminotransferase ( ALT ) concentration decreased in both groups ; this reduction was significantly greater in the synbiotic group . At the end of the study , the following significant differences [ means ( 95 % CIs ) ] were seen between the synbiotic and placebo groups , respectively : ALT [ -25.1 ( -26.2 , -24 ) compared with -7.29 ( -9.5 , -5.1 ) IU/L ; P 0.001 ] , aspartate aminotransferase [ -31.33 ( -32.1 , -30.5 ) compared with -7.94 ( -11.1 , -4.8 ) IU/L ; P ] , γ-glutamyltransferase [ -15.08 ( -15.5 , -14.7 ) compared with -5.21 ( -6.6 , -3.9 ) IU/L ; P protein [ -2.3 ( -3 , -1.5 ) compared with -1.04 ( -1.5 , -0.6 ) mmol/L ; P 0.05 ] , tumor necrosis factor-α [ -1.4 ( -1.7 , -1.1 ) compared with -0.59 ( -0.8 , -0.3 ) mmol/L ; P p65 [ -0.016 ( -0.022 , -0.011 ) compared with 0.001 ( -0.004 , -0.007 ) mmol/L ; P score as determined by transient elastography [ - 2.98 ( -3.6 , -2.37 ) compared with -0.77 ( -1.32 , -0.22 ) kPa ; P CONCLUSIONS Synbiotic supplementation in addition to lifestyle modification is superior to lifestyle modification alone for the treatment of NAFLD , at least partially through attenuation of inflammatory markers in the body . Whether these effects will be sustained with longer treatment duration s remains to be determined",
"Background : Non-alcoholic steatohepatitis ( NASH ) is a clinicopathological entity that is being recognized more frequently in recent years . This study aim ed to evaluate the effects of Metformin , with and without a probiotic supplement on liver aminotransferases in patients with NASH . Methods : Sixty four patients 18 - 75 years with NASH confirmed by biopsy and histological assessment were enrolled to study . Patients were r and omized to one of the following treatments for 6 months : Group I , probiotic ( Protexin two tablets per day ) plus Metformin 500 mg two tablets per day ( Met/Pro ) , or group II , Metformin 500 mg two tablets per day plus two placebo tablet ( Met/P ) . After 6 month alanine aminotransferase ( ALT ) , aspartate aminotransferase , and ultrasound grading of NASH were assessed . Results : In group I , serum alanine aminotransferase ( ALT : 133.7 ± 70 vs. 45.2 ± 32.5 ; P 0.00 ) , and aspartate aminotransferase activity ( AST : 123.1 ± 72 vs. 44.2 ± 33.9 ; P and ultrasound grading of NASH ( P while serum alanine aminotransferase ( ALT ) was not significantly reduced ( 118.4 ± 67.9 vs. 112.5 ± 68.7 ; P ( AST : 125.3 ± 71 vs. 113.4 ± 71 ; P did fall significantly ( P fell significantly in both groups . Conclusions : Probiotic combination with Metformin improves liver aminotransferases better than metformin alone in patients with NASH",
"Hepatic steatosis and fibrosis produce abnormal echo patterns on ultrasound scanning , but the potential of ultrasound scanning for diagnosing these conditions in routine clinical practice is uncertain . A prospect i ve comparative study of 85 patients with histologically assessed liver conditions was performed , and specificity was assessed in 76 patients with functional bowel disease who were presumed to have normal livers . Histological examination showed steatosis ranging from mild to severe in 48 patients and fibrosis ranging from increased fibrous tissue to established cirrhosis in 35 patients . Ultrasound scanning accurately identified steatosis , recognising 45 cases ( sensitivity 94 % ) with a specificity of 84 % . Fibrosis was less reliably detected ( sensitivity 57 % and specificity 88 % ) . Of the 50 patients with alcoholic liver disease , 47 ( 94 % ) yielded abnormal results on scanning . In the 76 patients with functional bowel disease there was only one false positive result , giving a specificity of 99 % in this group . As hepatic steatosis is the earliest change in alcoholic liver disease and seems to be of prognostic importance for the development of cirrhosis , ultrasound scanning provides an effective screening procedure , particularly in the occult alcoholic , who often presents with non-specific gastrointestinal complaints",
"Background : Nonalcoholic fatty liver disease ( NAFLD ) is the most common chronic liver disease in the world . Oral administration of symbiotic and Vitamin E has been proposed as an effective treatment in NAFLD patients . This study was carried out to assess the effects of symbiotic and /or Vitamin E supplementation on liver enzymes , leptin , lipid profile , and some parameters of insulin resistance ( IR ) in NAFLD patients . Material s and Methods : We r and omly assigned sixty NAFLD adult patients to receive ( 1 ) symbiotic twice daily + Vitamin E-like placebo capsule ; ( 2 ) 400 IU/d Vitamin E + symbiotic-like placebo ; ( 3 ) symbiotic twice daily + 400 IU/d Vitamin E ; and ( 4 ) symbiotic-like placebo + Vitamin E-like placebo for 8 weeks . Results : Symbiotic plus Vitamin E supplementation led to a significant decrease in concentrations of liver transaminase ( P ≤ 0.05 ) . Mean difference of apolipoprotein A-1 was more significant in symbiotic group compared to control . However , mean difference of apolipoprotein B100/A-1 was only significant in symbiotic group compared to control . At the end of the study , significant differences in total cholesterol ( TC ) and low-density lipoprotein cholesterol ( LDL-C ) were seen between the symbiotic plus Vitamin E and control groups ( P of symbiotic plus Vitamin E supplements led to a significant decrease in concentrations of triglycerides ( TG ) after the intervention . Significant differences in leptin , fasting blood sugar ( FBS ) , and insulin levels were seen between the symbiotic plus Vitamin E and control groups at the end of the study ( P contrast , symbiotic and /or Vitamin E supplementation did not affect high-density lipoprotein cholesterol and homeostasis model assessment for IR levels . Conclusion : In our study , symbiotic plus Vitamin E supplementation was the most effective treatment in lowering liver enzymes , leptin , FBS , insulin , TG , TC , and LDL-C among NAFLD patients",
"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",
"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",
"Objectives : This study aims to evaluate the effects of some probiotics on sonographic and biochemical nonalcoholic fatty liver disease ( NAFLD ) . Methods : This r and omized triple-blind trial was conducted among 64 obese children with sonographic NAFLD . They were r and omly allocated to receive probiotic capsule ( containing Lactobacillus acidophilus ATCC B3208 , 3 × 109 colony forming units [ CFU ] ; Bifidobacterium lactis DSMZ 32269 , 6 × 109 CFU ; Bifidobacterium bifidum ATCC SD6576 , 2 × 109 CFU ; Lactobacillus rhamnosus DSMZ 21690 , 2 × 109 CFU ) or placebo for 12 weeks . Results : After intervention , in the probiotic group the mean levels of alanine aminotransferase decreased from 32.8 ( 19.6 ) to 23.1 ( 9.9 ) U/L ( P = 0.02 ) and mean aspartate aminotransferase decreased from 32.2 ( 15.7 ) to 24.3 ( 7.7 ) U/L ( P = 0.02 ) . Likewise the mean cholesterol , low-density lipoprotein-C , and triglycerides as well as waist circumference decreased in the intervention group , without significant change in weight , body mass index , and body mass index z score . After the trial , normal liver sonography was reported in 17 ( 53.1 % ) and 5 ( 16.5 % ) of patients in the intervention and placebo groups , respectively . Conclusions : The present findings suggest that a course of the abovementioned probiotic compound can be effective in improving pediatric NAFLD",
"Gut microbiota modifiers may have beneficial effects of non‐alcoholic fatty liver disease ( NAFLD ) but r and omised controlled trials ( RCT ) are lacking in children ",
"BACKGROUND AND AIM Non-alcoholic fatty liver disease ( NAFLD ) is linked to metabolic syndrome , and is known to be associated with impaired fasting glycemia and diabetes mellitus . This prospect i ve community-based study was conducted to determine the association between NAFLD and incidence of diabetes mellitus in an urban adult population in Sri Lanka . METHODS Participants of the Ragama Health Study cohort were assessed for NAFLD using established ultrasound criteria in 2007 . Those who were free of diabetes at baseline were followed up for 3 years . Incidence rates of diabetes mellitus were compared between subjects with and without NAFLD at baseline . RESULTS Out of 2984 subjects , 926 had NAFLD and 676 had diabetes in 2007 . Of the 2276 subjects who were free of diabetes in 2007 , 1914 were re-assessed in 2010 . After 3 years , 104 out of 528 subjects with NAFLD and 138 out of 1314 subjects without NAFLD had developed diabetes mellitus de novo . Incidence rates of diabetes were respectively 64.2 and 34 per 1000 person-years of follow up for those with and without NAFLD . NAFLD was an independent predictor of developing diabetes mellitus . Other independent predictors were impaired fasting glycemia and dyslipidemia . CONCLUSIONS Subjects with ultrasonically diagnosed NAFLD have an increased risk of developing diabetes mellitus . Intervention for NAFLD through lifestyle modification may prevent progression of the current diabetes epidemic",
"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"
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BACKGROUND The available evidence on vitamin D and mortality is inconclusive . OBJECTIVES To assess the beneficial and harmful effects of vitamin D for prevention of mortality in adults . SEARCH STRATEGY We search ed The Cochrane Library , MEDLINE , EMBASE , LILACS , the Science Citation Index Exp and ed , and Conference Proceedings Citation Index-Science ( to January 2011 ) . We scanned bibliographies of relevant publications and asked experts and pharmaceutical companies for additional trials . SELECTION CRITERIA We included r and omised trials that compared vitamin D at any dose , duration , and route of administration versus placebo or no intervention . Vitamin D could have been administered as supplemental vitamin D ( vitamin D(3 ) ( cholecalciferol ) or vitamin D(2 ) ( ergocalciferol ) ) or an active form of vitamin D ( 1α-hydroxyvitamin D ( alfacalcidol ) or 1,25-dihydroxyvitamin D ( calcitriol ) ) . DATA COLLECTION AND ANALYSIS Six authors extracted data independently . R and om-effects and fixed-effect model meta-analyses were conducted . For dichotomous outcomes , we calculated the risk ratios ( RR ) . To account for trials with zero events , meta-analyses of dichotomous data were repeated using risk differences ( RD ) and empirical continuity corrections . Risk of bias was considered in order to minimise risk of systematic errors . Trial sequential analyses were conducted to minimise the risk of r and om errors . MAIN RESULTS Fifty r and omised trials with 94,148 participants provided data for the mortality analyses . Most trials included elderly women ( older than 70 years ) . Vitamin D was administered for a median of two years . More than one half of the trials had a low risk of bias . Overall , vitamin D decreased mortality ( RR 0.97 , 95 % confidence interval ( CI ) 0.94 to 1.00 , I(2 ) = 0 % ) . When the different forms of vitamin D were assessed separately , only vitamin D(3 ) decreased mortality significantly ( RR 0.94 , 95 % CI 0.91 to 0.98 , I(2 ) = 0 % ; 74,789 participants , 32 trials ) whereas vitamin D(2 ) , alfacalcidol , or calcitriol did not . Trial sequential analysis supported our finding regarding vitamin D(3 ) , corresponding to 161 individuals treated to prevent one additional death . Vitamin D(3 ) combined with calcium increased the risk of nephrolithiasis ( RR 1.17 , 95 % CI 1.02 to 1.34 , I(2 ) = 0 % ) . Alfacalcidol and calcitriol increased the risk of hypercalcaemia ( RR 3.18 , 95 % CI 1.17 to 8.68 , I(2 ) = 17 % ) . Data on health-related quality of life and health economics were inconclusive . AUTHORS ' CONCLUSIONS Vitamin D in the form of vitamin D(3 ) seems to decrease mortality in predominantly elderly women who are mainly in institutions and dependent care . Vitamin D(2 ) , alfacalcidol , and calcitriol had no statistically significant effect on mortality . Vitamin D(3 ) combined with calcium significantly increased nephrolithiasis . Both alfacalcidol and calcitriol significantly increased hypercalcaemia
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"Low dietary Ca intake and vitamin D insufficiency have been implicated as part of the aetiology leading to osteoporosis . The aim of the present study was to examine the effects of a 30-month dietary intervention that combined supplementation of dairy products fortified with Ca and vitamin D3 and lifestyle and nutrition counselling sessions on bone mineral density ( BMD ) of postmenopausal women . Sixty-six postmenopausal women ( aged 55 - 65 years ) were r and omised into a dietary group ( DG ; n 35 ) , receiving daily and for the first 12 months 1200 mg Ca and 7.5 microg vitamin D3 , while for the next 18 months of intervention 1200 mg Ca and 22.5 microg vitamin D3 through fortified dairy products , and a control group ( CG ; n 31 ) receiving neither counselling nor dairy products . The DG was found to have more favourable changes in arms ( P ) , total spine ( P = 0.001 ) and total body BMD ( P lumbar spine BMD ( 0.056 ; 95 % CI 0.009 , 0.103 ) , which was not found to differentiate significantly compared with the change observed in the CG ( P = 0.075 ) . In conclusion , the present study showed that intakes of vitamin D of about 22.5 microg/d and of Ca close to the recommended level of 1200 mg from fortified dairy foods for 30 months , with compliance ensured by lifestyle and nutrition counselling sessions , can induce favourable changes in arms , total spine and total body BMD of postmenopausal women",
"Aims : To investigate the effects of a 6-month supplementation with calcium and cholecalciferol on biochemical parameters and muscle strength of institutionalized elderly . Methods : This prospect i ve , double-blind , placebo-controlled , r and omized trial included Brazilian institutionalized people ≥60 years of age receiving a 6-month supplementation ( December to May ) of daily calcium plus monthly placebo ( calcium/placebo group ) or daily calcium plus oral cholecalciferol ( 150,000 IU once a month during the first 2 months , followed by 90,000 IU once a month for the last 4 months ; calcium/vitamin D group ) . Fasting blood sample s for 25(OH)D , PTH and calcium determination were collected ( n = 56 ) and muscle tests were performed ( n = 46 ) to measure the strength of hip flexors ( SHF ) and knee extensors ( SKE ) before ( baseline ) and after the 6-month intervention ( 6 months ) . Results : Due to seasonal variations , serum 25(OH)D significantly enhanced in both groups after treatment , but the calcium/vitamin D group had significantly higher 25 (OH)D levels than the calcium/placebo group ( 84 vs. 33 % , respectively ; p of hypercalcemia were observed . While the calcium/placebo group showed no improvement in SHF and SKE at 6 months ( p = 0.93 and p = 0.61 , respectively ) , SHF was increased in the calcium/vitamin D group by 16.4 % ( p = 0.0001 ) and SKE by 24.6 % ( p = 0.0007 ) . Conclusions : The suggested cholecalciferol supplementation was safe and efficient in enhancing 25(OH)D levels and lower limb muscle strength in the elderly , in the absence of any regular physical exercise practice",
"The purpose of this study was to ( 1 ) quantify the healing process of the human osteoporotic proximal humerus fracture ( PHF ) expressed in terms of callus formation over the fracture region using BMD scanning , and ( 2 ) quantify the impact of medical intervention with vitamin D3 and calcium on the healing process of the human osteoporotic fracture . The conservatively treated PHF was chosen in order to follow the genuine fracture healing without influence of osteosynthetic material s or casts . Thirty women ( mean age = 78 years ; range = 58–88 ) with a PHF , osteoporosis or osteopenia ( based on a hip scan , WHO criteria ) , and not taking any drugs related to bone formation , including calcium or vitamin D supplementation , were r and omly assigned to either oral 800 IU vitamin D3 plus 1 g calcium or placebo , in a double-blind prospect i ve study . We measured biochemical , radiographic , and bone mineral density effect parameters to evaluate the impact on the healing process . Scanning procedures of the fractured shoulder included use of a fixation device to obtain the highest possible precision . Double scans of the fractured shoulder revealed a coefficient of variation ( CV ) on BMD measurements that improved from 2.8 % immediately after fracture occurrence to 1.7 % at 12 weeks ( P = 0.003 ) approaching the 1.2 % levels observed over the healthy shoulder . BMD was similar in the two groups at baseline ( active 0.534 g/cm2 vs. placebo 0.518 g/cm2 ) , and both increased over the 12-week observation period , with peak levels in week 6 . By week 6 BMD levels were higher in the active group ( 0.623 g/cm2 ) compared with the placebo group ( 0.570 g/cm2 , P = 0.006 ) . Thirty seven percent of the patients presented with vitamin D levels below 30 nmol/l , indicative of mild vitamin D insufficiency . In conclusion , we have demonstrated that it is possible to quantify callus formation of the PHF with sufficiently high precision to demonstrate the positive influence of vitamin D3 and calcium over the first 6 weeks after fracture . Whether this results in more stable fractures , extends to other fracture types , or applies to other osteogenic bone agents such as bisphosphonates remains to be examined",
"BACKGROUND Ergocalciferol ( vitamin D(2 ) ) supplementation plays a role in fall prevention , but the effect in patients living in the community in sunny climates remains uncertain . We evaluated the effect of ergocalciferol and calcium citrate supplementation compared with calcium alone on the risk of falls in older women at high risk of falling . METHODS A 1-year population -based , double-blind , r and omized controlled trial of 302 community-dwelling ambulant older women aged 70 to 90 years living in Perth , Australia ( latitude , 32 degrees S ) , with a serum 25-hydroxyvitamin D concentration of less than 24.0 ng/mL and a history of falling in the previous year . Participants were r and omized to receive ergocalciferol , 1000 IU/d , or identical placebo ( hereinafter , ergocalciferol and control groups , respectively ) . Both groups received calcium citrate , 1000 mg/d . Fall data were collected every 6 weeks . RESULTS Ergocalciferol therapy reduced the risk of having at least 1 fall over 1 year after adjustment for baseline height , which was significantly different between the 2 groups ( ergocalciferol group , 53.0 % ; control group , 62.9 % ; odds ratio [ OR ] , 0.61 ; 95 % confidence interval [ CI ] , 0.37 - 0.99 ) . When those who fell were grouped by the season of first fall or the number of falls they had , ergocalciferol treatment reduced the risk of having the first fall in winter and spring ( ergocalciferol group , 25.2 % ; control group , 35.8 % ; OR , 0.55 ; 95 % CI , 0.32 - 0.96 ) but not in summer and autumn , and reduced the risk of having 1 fall ( ergocalciferol group , 21.2 % ; control group , 33.8 % ; OR , 0.50 ; 95 % CI , 0.28 - 0.88 ) but not multiple falls . CONCLUSION Patients with a history of falling and vitamin D insufficiency living in sunny climates benefit from ergocalciferol supplementation in addition to calcium , which is associated with a 19 % reduction in the relative risk of falling , mostly in winter",
"Background R and omised , placebo-controlled trials are needed to provide evidence demonstrating safe , effective interventions that reduce falls and fractures in the elderly . The quality of a clinical trial is dependent on successful recruitment of the target participant group . This paper documents the successes and failures of recruiting over 2,000 women aged at least 70 years and at higher risk of falls or fractures onto a placebo-controlled trial of six years duration . The characteristics of study participants at baseline are also described for this study . Methods The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm , adapted from identified risk factors for hip fracture . Participants were r and omised to orally receive either 500,000 IU vitamin D3 ( cholecalciferol ) or placebo every autumn for five consecutive years . A variety of recruitment strategies were employed to attract potential participants . Results Of the 2,317 participants r and omised onto the study , 74 % ( n = 1716/2317 ) were consented onto the study in the last five months of recruiting . This was largely due to the success of a targeted mail-out . Prior to this only 541 women were consented in the 18 months of recruiting . A total of 70 % of all participants were recruited as a result of targeted mail-out . The response rate from the letters increased from 2 to 7 % following revision of the material by a public relations company . Participant demographic or risk factor profile did not differ between those recruited by targeted mail-outs compared with other methods . Conclusion The most successful recruitment strategy was the targeted mail-out and the response rate was no higher in the local region where the study had extensive exposure through other recruiting strategies . The strategies that were labour-intensive and did not result in successful recruitment include the activities directed towards the GP medical centres . Comprehensive recruitment programs employ overlapping strategies simultaneously with ongoing assessment of recruitment rates . In our experience , and others direct mail-outs work best although rights to privacy must be respected . Trial registration IS RCT N83409867 and ACTR12605000658617",
"Abstract Objective To assess whether supplementation with calcium and cholecaliferol ( vitamin D3 ) reduces the risk of fracture in women with one or more risk factors for fracture of the hip . Design Pragmatic open r and omised controlled trial . Setting Practice nurse led clinics in primary care . Participants 3314 women aged 70 and over with one or more risk factors for hip fracture : any previous fracture , low body weight ( Intervention Daily oral supplementation using 1000 mg calcium with 800 IU cholecaliferol and information leaflet on dietary calcium intake and prevention of falls , or leaflet only ( control group ) . Main outcome measures Primary outcome measure was all clinical fractures and secondary outcome measures were adherence to treatment , falls , and quality of life ( measured with the SF-12 ) . Results 69 % of the women who completed the follow-up question naire at 24 months were still taking supplements ( 55 % with inclusion of r and omised participants known to be alive ) . After a median follow-up of 25 months ( range 18 to 42 months ) , clinical fracture rates were lower than expected in both groups but did not significantly differ for all clinical fractures ( odds ratio for fracture in supplemented group 1.01 , 95 % confidence interval 0.71 to 1.43 ) . The odds ratio for hip fracture was 0.75 ( 0.31 to 1.78 ) . The odds of a woman having a fall at six and 12 months was 0.99 and 0.98 , respectively . Quality of life did not significantly differ between the groups . Conclusion We found no evidence that calcium and vitamin D supplementation reduces the risk of clinical fractures in women with one or more risk factors for hip fracture . Registration IS RCT N26118436 , controlled trials registry",
"BACKGROUND Seasonal Affective Disorder ( SAD ) is a sub-type of depression that only occurs during the winter months . A reduction in vitamin D may be linked to SAD . Since vitamin D deficiency has been reported to be common in older people , vitamin D supplementation may be expected to reduce seasonal mood disturbance in this group . OBJECTIVE To assess the effect of vitamin D supplementation on the mental health of older women . SETTING Primary care in three areas of the UK ( Herts , Newcastle , York ) . SUBJECTS Women aged 70 years or more recruited to the trial in the months May-October . INTERVENTION Eligible women were r and omised to receive calcium and vitamin D supplementation or no supplementation . OUTCOME MEASURE At baseline and the six monthly assessment the mental component score ( MCS ) , calculated from the SF-12 question naire was used to assess participants ' subjective psychological well-being . RESULTS A total of 2117 women recruited to the trial had their baseline measures taken between the months of May-October ( 1205 woman in the control group and 912 women in the intervention group ) . Of these women , 1621 had a MCS score at baseline and six months . Comparison of the six month mean MCS scores , adjusting for baseline MCS score and age , showed there was no significant difference between the two scores ( p = 0.262 ) . CONCLUSIONS Supplementing elderly women with 800 IU of vitamin D daily did not lead to an improvement in mental health scores",
"In this prospect i ve study , the authors determined intrinsic risk factors for falls and recurrent falls and constructed a risk profile that indicated the relative contribution of each risk factor and also estimated the probabilities of falls and recurrent falls . In 1992 , over a 28-week period , falls were recorded among 354 elderly subjects aged 70 years or over who were living in homes or apartments for the elderly in Amsterdam and the vicinity . During the study period , 251 falls were reported by 126 subjects ( 36 % ) , and recurrent falls ( > or = 2 falls ) were reported by 57 subjects ( 16 % ) . Associations of falls and recurrent falls with potential risk factors were identified in logistic regression models . Mobility impairment regarding one or more of the tested items ( i.e. , impairment of balance , leg-extension strength , and gait ) was associated with falls ( adjusted odds ratio ( OR ) = 2.6 ) and was strongly associated with recurrent falls ( OR = 5.0 ) . Dizziness upon st and ing was associated with falls ( OR = 2.1 ) and recurrent falls ( OR = 2.1 ) . However , several risk factors were associated with recurrent falls only : history of stroke ( OR = 3.4 ) , poor mental state ( OR = 2.4 ) , and postural hypotension ( OR = 2.0 ) . The authors constructed a risk profile for recurrent falls that included the five risk factors mentioned above . Inclusion of all risk factors in the profile implied an 84 % probability of recurrent falls over a period of 28 weeks , compared with 3 % when no risk factor was present . The probability of recurrent falls ranged only from 11 % to 29 % when predicted by number of falls occurring in the previous year . Physical activity , use of high-risk medication , and the use of vitamin D3 , which was r and omly allocated to the participants , were not strongly related to either falls or recurrent falls . In conclusion , a large range of probabilities of falls , especially of recurrent falls , was estimated by the risk profiles , in which mobility impairment was the major risk factor . Recurrent fallers may therefore be especially amenable to prevention based on mobility improvement",
"Background and aims : Insufficient vitamin D status , commonly found in older people , has been associated with muscle weakness which , in old age , impairs mobility and is a risk factor for falling . In a r and omized , double-blind placebo-controlled trial , we tested the hypothesis that vitamin D + calcium supplementation improves muscle strength and mobility , compared with calcium mono-therapy in vitamin D-insufficient female geriatric patients . Methods : Seventy female geriatric patients > 65 years of age with serum 25-hydroxyvitamin D3 ( 25OHD ) concentrations between 20 and 50 nmol/L , visiting an outpatient geriatric department , were included . Participants received either cholecalciferol 400 IU/day + calcium 500 mg/day ( D/Cal group ) or a placebo + calcium 500 mg/day ( Plac/Cal group ) for 6 months . At baseline and 6 months , muscle strength , power and functional mobility were tested . Results : At baseline , 25OHD was significantly ( p with knee extension strength ( r=0.42 ) , h and grip strength ( r=0.28 ) , leg extension power ( r=0.34 ) , Timed Get Up and Go ( r=−0.31 ) and Modified Cooper test ( r=0.44 ) . At 6 months , a significant difference in 25OHD ( 77.2 vs 41.6 nmol/L , p and 1,25OHD was found between the two groups . Significantly improving vitamin D status in the D/Cal group compared with the Plac/Cal group did not result in a significant difference in strength or functional mobility between the two groups . Conclusions : Daily 400IU vitamin D + 500 mg calcium supplementation is not enough to significantly improve strength or mobility in vitamin D-insufficient female geriatric patients",
"Abstract . To assess the efficacy and acceptability of vitamin D-fortified liquid milk in the management of hypovitaminosis D we carried out a double-blind , r and omized , controlled trial on 51 community-based , elderly subjects with serum 25 hydroxyvitamin D ( 25OHD ) levels of less than 12.9 ng/ml ( normal range 10–80 ng/ml ) . Each subject had a dietary assessment , mental test score , outdoor score , serum 25 hydroxyvitamin D level , and a general biochemical screening at baseline in April 1993 which was repeated in September 1993 , April 1994 , and September 1994 . All subjects received 500 ml of milk per day , delivered to their homes in specially manufactured , blank , tetrapak cartons , from June 1993 to June 1994 : 23 subjects received unfortified milk ( control group ) and 28 subjects received fortified milk ( active group ) . Our results showed a baseline mean 25OHD level in the active group of 9.6 ( range mean 25OHD level in the active group had risen significantly from its baseline to 18.5 ( range 9.6–26.7 ) ng/ml ( P ) . Serum calcium levels in the active group also showed a significant rise over the 1-year period ( P vitamin D-fortified liquid milk is a safe , effective , and acceptable method of administering vitamin D to the elderly , community-based population",
"The aim of the current study was to examine whether calcium supplementation could prevent bone loss in postmenopausal women or more favourable outcomes could be obtained via the consumption of dairy products fortified with calcium and vitamin D3 . For this purpose changes in bone mineral density ( BMD ) at different skeletal sites , assessed by dual-energy X-ray absorptiometry , as well as in quantitative ultrasound ( QUS ) parameters of the calcaneus over 12 months were estimated . A population of 101 postmenopausal women ( 55 - 65 years old ) was r and omized into a dairy group ( DG : n 39 ) , receiving approximately 1200 mg calcium/d and 7.5 microg vitamin D3/d through fortified dairy products ; a calcium-supplemented group ( CaG : n 26 ) provided with a calcium supplement of 600 mg/d ; and a control group ( CG : n 36 ) . Over the intervention period the DG was found to have more favourable changes in pelvis ( P=0.040 ) , total spine ( P total body BMD ( P lumbar spine BMD ( 2.0 % ; 95 % CI 0.5 , 3.5 ) although it did not differentiate significantly compared to the other groups . No significant differences were observed with respect to the changes in QUS parameters . The current study revealed that recommended intakes of vitamin D3 and calcium via fortified dairy products for 12 months can induce favourable changes in pelvis , total spine and total body BMD in postmenopausal women but not in QUS parameters . No such favourable changes were observed via supplementation of calcium alone",
"Malabsorption of calcium is a common finding in patients with postmenopausal osteoporosis ( 1 , 2 ) . In a number of studies serum 1,25 dihydroxyvitamin D levels were found to be significantly lower in osteoporotic patients , which could account for the calcium absorptive defect ( 3–6 ) . Based on these findings , we studied the effects of synthetic calcitriol ( Rocaltrol ) in women with osteoporosis . We showed that calcitriol , 0.25 μg twice daily , improved and normalized the absorption of calcium in all patients and improved calcium balance ( 7 ) . Urine hydroxyproline , which is a measure of bone resorption , decreased significantly after 2 years of treatment with Rocaltrol . Because of these preliminary findings , further clinical studies were carried out at two centers using a variable dose of Rocaltrol . In these studies we focused on the effectiveness of Rocaltrol in preventing vertebral fractures in patients with spinal osteoporosis . Methods The results from two centers have been analyzed both as separate groups and as one combined group . One study was performed at the Mayo Clinic ( Protocol 861 ) and the other at Creighton University ( Protocol 860 ) . In both centers the studies performed were double blind and r and omized , and compared the effect of placebo against Rocaltrol for a period of 1 year . At the end of 1 year all patients on placebo were crossed over to treatment with Rocaltrol and followed for 2 more years . Patients initially treated with Rocaltrol were followed for an additional 2 years , thus yielding treatment data extending to 3 years in a number of patients . In the study design , patients were given Rocaltrol at a starting dose of 0.25 μg twice daily , if hypercalcemia and hypercalciuria did not occur the dose then was increased to 0.75 μg or 1.0 μg daily at the discretion of the investigator",
"OBJECTIVE To assess the cost implication s for a preventive treatment strategy for institutionalised elderly women with a combined 1200 mg/day calcium and 800 IU/day vitamin D(3 ) supplementation in seven European countries . DESIGN Retrospective cost effectiveness analysis based on a prospect i ve placebo-controlled r and omised clinical trial . DATA SOURCES Recently published cost studies in seven European countries . Clinical results from Decalyos , a 3-year placebo-controlled study in elderly institutionalised women . TRIALS Decalyos study , with 36 months follow-up of 3270 mobile elderly women living in 180 nursing homes , allocated to two groups . One group received 1200 mg/day elemental calcium in the form of tricalcium phosphate together with 800 IU/day ( 20 microg ) of cholecalciferol ( vitamin D(3 ) ) , the other placebo . RESULTS In the 36 months analysis of the Decalyos study , 138 hip fractures occurred in the group of 1176 women , receiving supplementation and 184 hip fractures in the placebo group of 1127 women . The mean duration of treatment was 625.4 days . Adjusted to 1000 women , 46 hip fractures were avoided by the calcium and vitamin D(3 ) supplementation . For all countries , the total costs in the placebo group were higher than in the group receiving supplementation , result ing in a net benefit of 79000 - 711000 per 1000 women . CONCLUSION This analysis suggests that the supplementation strategy is cost saving . The results may underestimate the net benefits , as this treatment has also shown to be effective in decreasing the incidence of other non-vertebral fractures in elderly institutionalised women",
"Globally , cardiovascular disease ( CVD ) is the number one cause of death , being responsible for approximately 30 % of deaths worldwide . Urbanization and a westernized lifestyle are thought to play a major role in the development of CVD . There is accumulating evidence that vitamin D is a nonclassical risk factor for CVD . The active vitamin D metabolite , 1,25-dihydroxyvitamin D , which is synthesized from its precursor 25-hydroxyvitamin D ( 25[OH]D ) , down-regulates several negative and up-regulates various protective pathways in the heart and vasculature . First r and omized trials demonstrate that vitamin D supplementation leads to vasodilatation and suppresses cardiovascular risk markers such as triglycerides and the inflammation marker tumor necrosis factor-α . Solar UV-B radiation is the major source of vitamin D for humans . Consequently , the vitamin D status is largely influenced by season , geographic latitude , daily outdoor activities , and the percentage of body surface exposed to solar UV-B. A significant proportion of individuals in Europe and North America have vitamin D concentrations in the deficiency range ( 25[OH]D low solar UV-B exposure and /or low 25(OH)D concentrations are associated with an increased risk of CVD . Large nonr and omized studies indicate that CVD mortality is more than twice as high in older individuals with deficient 25(OH)D concentrations compared with those individuals who have adequate 25(OH)D concentrations ( > 75 nmol/l ) . Together , experimental and epidemiological evidence does support a plausible role for improving vitamin D status in CVD prevention in the population at large . Nevertheless , future r and omised clinical trials are needed to evaluate whether vitamin D is effective with respect to primary , secondary , and /or tertiary prevention of CVD"
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41173cb4-06ff-11f0-808a-c43d1ab1c353
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Background : Fatigue is the most common and unpleasant symptom of patients with systemic lupus erythematosus ( SLE ) . However , there is limited information regarding how exercise affects fatigue . Aims : The purpose of this study is to review and synthesize the current knowledge concerning the effectiveness of exercise training for treating fatigue among adults with SLE . The characteristics of beneficial exercise training are further evaluated . Methods : We conducted a systematic review and meta‐ analysis . The data bases search ed were MEDLINE , CINAHL , PEDro , Cochrane Library , Scopus , and PQDT from their inception to February 3 , 2016 . The quality of each selected study was assessed using the PEDro scale . A between‐group analysis was performed to evaluate the effectiveness of the exercise training . Data were analyzed using the Cochrane Collaboration 's RevMan 5.3 ( Copenhagen , Denmark ) . Results : Two r and omized controlled trials and one quasiexperimental study were included in this systematic review and meta‐ analysis . Aerobic exercise , three times a week and of moderate intensity , was a common component of the three studies . Two studies were conducted in a supervised setting and one study was based at home . One study lasted 8 weeks and two studies lasted 12 weeks . The meta‐ analysis showed that aerobic exercise could decrease fatigue ( MD = –.52 , 95 % confidence interval [ CI ] [ –.91 , –.13 ] , p = .009 ) and increase vitality ( MD = 14.98 , 95 % CI [ 7.45 , 22.52 ] , p of exercise training and exercise under a supervised setting significantly benefited fatigue . Linking Evidence to Action : The pooled data indicate that 12 weeks of an aerobic exercise program that is supervised by health professionals could reduce fatigue and increase vitality for patients with SLE . SLE patients with mild disease should begin with moderate intensity for at least 20 minutes , 3 days a week
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"OBJECTIVE To determine if supervised cardiovascular training improves exercise tolerance , aerobic capacity , depression , functional capacity , and quality of life in patients with systemic lupus erythematosus ( SLE ) . METHODS Sixty women with SLE ( ages 18 - 55 years ) were evaluated using Short Form 36 , visual analog scale for pain , scale for fatigue , Beck Depression Inventory , and Health Assessment Question naire ( HAQ ) , and participated in a training protocol of incremental load on a treadmill with computed gas metabolic analysis . Maximum oxygen consumption ( VO(2max ) ) and anaerobic threshold VO(2 ) were calculated with a SensorMedics Vmax29C analyzer ( Sensor Medics , Yorba Linda , CA ) , and heart rate was measured by electrocardiogram . Patients were divided into 2 groups : a training group ( 41 patients ) that participated in the supervised cardiovascular training program and a control group ( 19 patients ) that did not participate in the program . All variables were analyzed at baseline and after 12 weeks for both groups . The training program occurred in the morning for 60 minutes , 3 times a week for 12 weeks . Statistical analysis included Wilcoxon 's rank sum test , Mann-Whitney U test , chi-square test , and Fisher 's exact test . P values aerobic capacity measured by anaerobic threshold VO(2 ) ( 14.67 + /- 3.03 versus 17.08 + /- 3.35 ml/kg/minute , P VO(2max ) ( 24.31 + /- 4.61 versus 21.21 + /- 3.88 ml/kg/minute , P = 0.01 ) and anaerobic threshold VO(2 ) ( 17.08 + /- 3.35 versus 13.66 + /- 2.82 ml/kg/minute , P Beck inventory score ( 8.37 + /- 12.79 versus 2.90 + /- 3.00 , P HAQ score ( 0.14 + /- 0.21 versus 0.06 + /- 0.19 , P exercise tolerance , aerobic capacity , quality of life , and depression after a supervised cardiovascular training program in patients with SLE",
"OBJECTIVE A pilot study was design ed to assess the efficacy and safety of different exercise therapies on patient-reported fatigue and functional status . METHODS Ten patients with systemic lupus erythematosus ( SLE ) were r and omly placed in either an aerobic exercise group ( group 1 : n = 5 ) or a range of motion/muscle strengthening ( ROM/MS ) exercise group ( group 2 : n = 5 ) . Outcome measures assessed at baseline and the end of the study were fatigue , functional status , disease activity , cardiovascular fitness , isometric strength , bone mineral density ( BMD ) of the lumbar spine and femoral neck , and parathyroid hormone and osteocalcin as representative bone biochemical markers for bone resorption and bone formation , respectively . RESULTS Both aerobic and ROM/MS types of exercise were safe and did not worsen SLE disease activity . Patients in both exercise groups showed some improvement in fatigue , functional status , cardiovascular fitness , and muscle strength . Both groups showed increased bone turnover , but BMD was unchanged . Eighty percent of the patients met the compliance st and ard for the study . CONCLUSIONS This pilot study shows the feasibility of exercise for SLE patients . The potential value of this approach shows promise in the routine management of these patients",
"How should health care professionals choose among the many therapies cl aim ed to be efficacious for treating specific disorders ? The practice of evidence -based medicine provides an answer . Advocates of this approach urge health care professionals to base treatment choices on the best evidence from systematic research on both the efficacy and adverse effects of various therapeutic alternatives . Ideally , health care professionals would compare different treatments by referring to r and omized , double-blind , head-to-head trials that compared the treatment options . Although individual medications are typically well research ed when these placebo-controlled studies are performed , studies that directly compare treatments are rare . In the absence of direct head-to-head trials , other evidence comes from indirect comparisons of two or more therapies by examining individual studies involving each treatment . This article provides an introductory review of methods of such indirect comparisons of therapies across studies , provides examples of how these methods can be used to make treatment decisions , and presents a general overview of relevant issues and statistics for readers interested in underst and ing these methods more thoroughly",
"OBJECTIVE To measure aerobic fitness , muscle strength , fatigue , and physical disability in patients with systemic lupus erythematosus ( SLE ) . METHODS Ninety-three patients with SLE and 41 sedentary controls were recruited into the study . Aerobic fitness was assessed by monitoring peak and submaximal oxygen uptake , heart rate , duration of exercise , and perceived exertion during a treadmill-walking test . Strength was measured using voluntary isometric quadriceps contraction . Symptomatic measures included physical and mental fatigue , mood , sleep , and functional incapacity . RESULTS Compared to sedentary controls patients with SLE had significantly reduced levels of aerobic fitness ( mean VO2peak SLE patients , 23.2 ml/kg/min vs controls , 29.6 ml/kg/min ; p reduced exercise capacity ( mean exercise duration SLE patients , 10.4 min vs controls , 13.1 min ; p muscle strength ( mean maximum voluntary quadriceps contraction SLE patients , 298 N vs controls , 376 N ; p = 0.003 ) . Resting lung function was also significantly worse in the SLE patients ( mean FEV , SLE patients , 2.6 l vs controls , 2.9 l ; p = 0.002 ) . Fatigue ( p depressed mood ( p poor sleep quality ( p functional incapacity ( p physical disability correlated with aerobic fitness ( p fatigue ( p = 0.005 ) , body mass index ( p = 0.01 ) , and depression ( p = 0.05 ) and that fatigue correlated with depression ( p CONCLUSION Patients with SLE were less fit with reduced exercise capacity , reduced muscle strength , more fatigue , and greater disability compared to sedentary controls . Treatments developed to manage depression and improve aerobic fitness should be considered in the overall treatment of fatigue and disability in SLE",
"The effectiveness of an exercise prescription and unsupervised home exercise programme was tested on 37 subjects with rheumatoid arthritis and 34 with systemic lupus erythematosus . Subjects were r and omly assigned to control or stationary bicycling at home , using loaned bicycles . Exercise subjects ( with bicycles ) did better than controls , but not significantly , on all outcome d measures ( exercise tolerance test , fatigue , depression and helplessness ) at 3 months . Bicycles were recl aim ed at 3 months and all subjects in both groups given instructions for home exercise . Exercise in the second 3 months was predicted primarily by baseline exercise habits and fatigue . It is concluded that although safe , unsupervised home exercise programmes may benefit few patients . Future research should address methods of stimulating and maintaining unsupervised exercise programmes in patients with systemic rheumatic disease",
"Purpose The extent and variability of unmet care needs over time of people with systemic lupus erythematosus ( SLE ) has not been previously reported . A prospect i ve study was undertaken to determine the variability over time of such needs . Method A 97-item SLE needs question naire ( SLENQ ) was completed on two occasions 6 months apart by 233 members of a lupus support association . Levels of unmet need for each individual , and a mean symptom score were calculated . Results Overall level of unmet need increased , decreased or stayed the same for 18 % , 37 % , and 45 % of participants respectively . Ninety-four percent of participants at time 1 and 95 % of participants at time 2 reported an unmet need for care for at least one item . The prevalence of unmet need for care remained the same for 82 of the 97 items . The mean unmet need score declined significantly between time 1 ( 0.78 ) and time 2 ( 0.69 ) . The mean unmet need scores were significantly correlated with mean symptom score . Conclusions The results of the study suggest an unacceptable persistence of care needs not being met . There is an ongoing need to identify mechanisms to enhance care delivery so that the care needs of people with SLE are more effectively addressed",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"OBJECTIVE To test the efficacy of a grade d aerobic exercise programme in treating fatigue in systemic lupus erythematosus . METHODS Ninety-three patients with systemic lupus erythematosus without active disease in any major organ were r and omized , using a minimization protocol , to 12 weeks of grade d exercise therapy , relaxation therapy or no intervention . RESULTS Analysis by intention to treat showed that 16 of the 33 ( 49 % ) patients in the exercise group rated themselves as ' much ' or ' very much ' better compared with eight out of 29 ( 28 % ) in the relaxation group and five out of 32 ( 16 % ) in the control group ( chi2=8.3 , df=2 , P=0.02 ) . Fatigue improved significantly on one out of three measures after exercise therapy and there was a trend for fatigue to improve on all measures after exercise . CONCLUSION These findings support the use of appropriately prescribed grade d aerobic exercise in the management of patients with fatigue and systemic lupus erythematosus"
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41173cfa-06ff-11f0-808a-c43d1ab1c353
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The purpose of the study was to make a systematic review and describe and confront recent studies that compare the presence of disordered eating and its complications in young female athletes and controls subjects - PubMed , Scielo , Medline , ScienceDirect , WILEY InterScience , Lilacs and Cochrane were the data bases used for this review . Out of 169 studies 22 were selected and 11,000 women from 68 sports were studied . The short version of the EAT was the most common instrument used to track disordered eating . Results showed that 55 % found no significant difference in the percentage of disordered eating between athletes and controls . Also a higher percentage of studies reported higher frequency of menstrual dysfunction in athletes than controls and finally 50 % of the studies found incidence of low bone mass in controls . Not all the studies that investigated all the conditions in the triad , but the authors concluded that it seemed that athletes were in more severe stage of this disorder . Due to the heterogeneity of the studies , a definitive conclusion about the groups and at highest risk for disordered eating and its complications remains to be eluci date
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"The purpose s of this study were to examine the percentage of female elite athletes and controls with disordered eating ( DE ) behavior and clinical eating disorders ( EDs ) , to investigate what characterize the athletes with EDs , and to evaluate whether a proposed method of screening for EDs in elite athletes does not falsely classify sport-specific behaviors as indicators of EDs . All athletes representing the national teams at the junior or senior level , aged 13 - 39 years ( n=938 ) , and age-group matched , r and omly selected population -based controls ( n=900 ) were invited to participate . From the screening data , a r and om sample of athletes ( n=186 ) and controls ( n=145 ) were subjects for a clinical interview . More athletes in leanness sports ( 46.7 % ) had clinical EDs than athletes in non-leanness sports ( 19.8 % ) and controls ( 21.4 % ) ( P clinical EDs , and thus c and i date s for valid screening procedures , were menstrual dysfunction in leanness athletes , self-reported EDs in non-leanness athletes , and self-reported use of pathogenic weight control methods in controls . Hence , statistically based risk factors are not universally valid , but specifically related to athletes and non-athletes , respectively",
"PURPOSE To examine the prevalence of the female athlete triad ( the Triad ) in Norwegian elite athletes and controls . METHODS This study was conducted in three phases : ( part I ) screening by means of a detailed question naire , ( part II ) measurement of bone mineral density ( BMD ) , and ( part III ) clinical interview . In part I , all female elite athletes representing the national teams at junior or senior level , aged 13 - 39 yr ( N = 938 ) and an age group-matched r and omly selected population -based control group ( N = 900 ) were invited to participate . The question naire was completed by 88 % of the athletes and 70 % of the controls . Based on data from part I , a stratified r and om sample of athletes ( N = 300 ) and controls ( N = 300 ) was selected and invited to participate in parts II and III of the study . 186 athletes ( 62 % ) and 145 controls ( 48 % ) participated in all parts of the study . RESULTS Eight athletes ( 4.3 % ) and five controls ( 3.4 % ) met all the criteria for the Triad ( disordered eating/eating disorder , menstrual dysfunction , and low BMD ) . Six of the athletes who met all the Triad criteria competed in leanness sports , and two in nonleanness sports . When evaluating the presence of two of the components of the Triad , prevalence ranged from 5.4 to 26.9 % in the athletes and from 12.4 to 15.2 % in the controls . CONCLUSION Our results support the assumption that a significant proportion of female athletes suffer from the components of the Triad . In addition , we found that the Triad is also present in normal active females . Therefore , prevention of one or more of the Triad components should be geared towards all physically active girls and young women",
"PURPOSE To evaluate the effect of an oral contraceptive ( OC ) on bone mineral density ( BMD ) in adolescent females with anorexia nervosa ( AN ) or eating disorder not otherwise specified ( EDNOS ) . METHODS Females 11 - 17 years of age with AN or EDNOS entered the study . Subjects were r and omized equally to treatment with a triphasic OC containing norgestimate ( NGM ) 180 - 250 microg and ethinyl estradiol ( EE ) 35 microg or placebo for 13 28-day cycles . Dual energy x-ray absorptiometry scans ( DXA ) of the lumbosacral spine ( LS ) and hip were obtained at baseline and after 6 and 13 cycles . RESULTS Demographic characteristics of the 112 subjects ( NGM/EE 53 ; Placebo 59 ) who received study drug and had at least one on-treatment DXA were similar between groups for age ( mean : 15 years in each group ) and body mass index ( mean : NGM/EE 17.9 kg/m2 ; Placebo 17.6 kg/m2 ) . At the end of Cycle 6 , there was a significant increase in the mean LS BMD in the NGM/EE group compared with placebo ( .020 g/cm2 vs. .008 g/cm2 ; p = .021 ) ; however , at the end of Cycle 13 the mean increase in LS BMD in the NGM/EE group compared with placebo was no longer significant ( .026 g/cm2 vs. .019 g/cm2 , p = .244 ) . There was no significant difference in change in hip BMD between groups . The incidence of adverse events was similar between groups . CONCLUSIONS In a group of adolescent females with AN or EDNOS , treatment with a triphasic OC for 13 cycles did not have a statistically significant effect on LS or hip BMD ",
"The aims were to examine the percentage of female elite athletes and controls reporting sexual harassment and abuse ( SHAB ) , and whether a higher percentage of female athletes with eating disorders ( ED ) had experienced SHAB . A question naire was administered to the total population of female elite athletes ( n = 660 ) and controls ( n = 780 ) aged 15 - 39 years . Sexual harassment and abuse were measured through 11 questions , ranging from light to severe SHAB . In addition , questions about dietary- , menstrual- and training-history and the Eating Disorder Inventory were included . The response rate was 88 % for athletes and 71 % for controls . Athletes ( n = 121 ) and controls ( n = 81 ) classified as \" at risk \" for ED and non-ED controls participated in a clinical interview . A higher percentage of controls compared with athletes reported experiences of SHAB in general ( 59 % vs. 51 % , P SHAB inside sports than outside sport ( 28 % vs. 39 % , P SHAB ( 66 % vs. 48 % , P < 0.01 ) , both inside sport and outside sport . In spite of the fact that a higher percentage of controls compared with athletes had experienced SHAB , it is necessary to formulate clear guidelines , set up educational workshops and implement intervention programs for both ED and SHAB in sport",
"To investigate the dependence of LH pulsatility on energy availability ( dietary energy intake minus exercise energy expenditure ) , we measured LH pulsatility after manipulating the energy availability of 29 regularly menstruating , habitually sedentary , young women of normal body composition for 5 d in the early follicular phase . Subjects expended 15 kcal/kg of lean body mass ( LBM ) per day in supervised exercise at 70 % of aerobic capacity while consuming a clinical dietary product to set energy availability at 45 and either 10 , 20 , or 30 kcal/kg LBM.d in two r and omized trials separated by at least 2 months . Blood was sample d daily during treatments and at 10-min intervals for the next 24 h. Sample s were assayed for LH , FSH , estradiol ( E2 ) , glucose , beta-hydroxybutyrate , insulin , cortisol , GH , IGF-I , IGF-I binding protein (IGFBP)-1 , IGFBP-3 , leptin , and T3 . LH pulsatility was unaffected by an energy availability of 30 kcal/kg LBM.d ( P > 0.3 ) , but below this threshold LH pulse frequency decreased , whereas LH pulse amplitude increased ( all P women with short luteal phases ( P energy availability on plasma glucose , beta-hydroxybutyrate , GH , and cortisol and contrasted with the dependencies displayed by the other metabolic hormones ( simultaneously P LH pulsatility is disrupted only below a threshold of energy availability deep into negative energy balance and suggest priorities for future investigations into the mechanism that mediates the nonlinear dependence of LH pulsatility on energy availability",
"PURPOSE This study investigated the influence of different exercise types and differences in anatomical distribution of mechanical loading patterns on bone mineral density ( BMD ) in elite female cyclists , runners , swimmers , triathletes , and controls ( N = 15 per group ) . Associations between leg strength and BMD were also examined . METHODS Areal BMD ( g x cm(-2 ) ) was assessed by duel-energy x-ray absorptiometry ( DXA ) ( total body ( TB ) , lumbar spine ( LS ) , femoral neck ( FN ) , legs , and arms ) . Right knee flexion and extension strength was measured using a Cybex Norm isokinetic dynamometer at 60 degrees x s(-1 ) . RESULTS Runners had significantly higher unadjusted TB , LS , FN , and leg BMD than controls ( P TB , FN , and leg BMD than swimmers ( P leg BMD than cyclists ( P Absolute knee extension strength was significantly ( P TB , FN , LS , and leg BMD for all groups combined . Weaker but still significant correlations ( 0.28 normalized ( per leg lean tissue mass ) knee extension strength and all BMD sites , except FN BMD . There were no significant correlations between absolute or normalized knee flexion strength and any of the BMD variables . Absolute knee extension strength was entered as the second independent predictor for LS and leg BMD in stepwise multiple linear regression analysis ( MLRA ) , accounting for increments of 4 % and 12 % , respectively , in total explained variation . CONCLUSION We conclude that running , a weight bearing exercise , is associated with larger site-specific BMD than swimming or cycling , that the generalized anatomical distribution of loads in triathlon appears not to significantly enhance total body BMD status , and that knee extension strength is only a weak correlate and independent predictor of BMD in adolescent females",
"OBJECTIVE This paper examines diagnostic agreement between interview and question naire assessment s of women participating in a long-term follow-up study of bulimia nervosa . METHODS Women ( N = 162 ) completed follow-up evaluations comprising question naires and either face-to-face or telephone interviews . RESULTS Consistent with previous research , rates of eating disorders were higher when assessed by question naire than when assessed by interview ; however , rates of full bulimia nervosa were similar . Overall diagnostic agreement was adequate for eating disorders ( kappa=.64 ) but poor for bulimia nervosa ( kappa=.49 ) , with greater agreement between question naires and telephone interviews ( kappa 's range : .67-.71 ) than between question naires and face-to-face interviews ( kappa 's range : .35-.58 ) . CONCLUSION Findings support the possibility that increased rates of eating pathology on question naire assessment s may be due , in part , to increased c and or when participants feel more anonymous . Question naire assessment s may not be inferior to interview assessment s ; they may reveal different aspects of disordered eating",
"UNLABELLED To help refine nutritional guidelines for military servicewomen , we assessed bone turnover after manipulating the energy availability of 29 young women . Bone formation was impaired by less severe restrictions than that which increased bone resorption . Military servicewomen and others may need to improve their nutrition to avoid these effects . INTRODUCTION We determined the dose-response relationship between energy availability ( defined as dietary energy intake minus exercise energy expenditure ) and selected markers of bone turnover in 29 regularly menstruating , habitually sedentary , young women of normal body composition . MATERIAL S AND METHODS For 5 days in the early follicular phase of two menstrual cycles separated by at least 2 months , subjects expended 15 kcal/kgLBM/day in supervised exercise at 70 % of aerobic capacity and consumed controlled amounts of a clinical dietary product in balanced ( 45 kcal/kgLBM/day ) and one of three restricted ( either 10 , 20 , or 30 kcal/kgLBM/day ) energy availability treatments in r and om order . Blood was sample d at 10-minute intervals , and urine was collected for 24 h. Sample s were assayed for plasma osteocalcin ( OC ) , serum type I procollagen carboxy-terminal propeptide ( PICP ) , and urinary N-telopeptide ( NTX ) . RESULTS NTX concentrations ( p indices of bone resorption/formation uncoupling ( Z(NTX-OC ) and Z(NTX-PICP ) ; both p OC and PICP concentrations were suppressed by all restricted energy availability treatments ( all p PICP declined linearly ( p OC occurred abruptly between 20 and 30 kcal/kgLBM/day ( p NTX and estradiol ; for PICP and insulin ; and for OC , triiodothyronine ( T3 ) , and insulin-like growth factor (IGF)-I. The uncoupling of bone resorption and formation by severely restricted energy availability , if left to continue , may lead to irreversible reductions in BMD , and the suppression of bone formation by less severe restrictions may prevent young women from achieving their genetic potential for peak bone mass . More prolonged experiments are needed to determine the dose-response relationships between chronic restrictions of energy availability and bone turnover",
"Objective : To determine the prevalence of the female athlete triad ( low energy availability , menstrual dysfunction , and low bone mineral density ) in high school varsity athletes in a variety of sports compared with sedentary students/control subjects . Design : Prospect i ve study . Setting : Academic medical center in the Midwest . Participants : Eighty varsity athletes and 80 sedentary students/control subjects volunteered for this study . Intervention : Subjects completed question naires , had their blood drawn , and underwent bone mineral density testing . Main Outcome Measures : Each participant completed screening question naires assessing eating behavior , menstrual status , and physical activity . Each subject completed a 3-day food diary . Serum hormonal , thyroid-stimulating hormone , and prolactin levels were determined . Bone mineral density and body composition were measured by dual-energy x-ray absorptiometry . Results : Low energy availability was present in similar numbers of athletes ( 36 % ) and sedentary/control subjects ( 39 % ; P = 0.74 ) . Athletes had more menstrual abnormalities ( 54 % ) compared with sedentary students/control subjects ( 21 % ) ( P low bone mineral density ( P = 0.03 ) . Risk factors for reduced bone mineral density include sedentary control student , low body mass index , and increased caffeine consumption . Conclusions : A substantial number of high school athletes ( 78 % ) and a surprising number of sedentary students ( 65 % ) have 1 or more components of the triad . Given the high prevalence of triad characteristics in both groups , education in the formative elementary school years has the potential to prevent several of the components in both groups , therefore improving health and averting long-term complications",
"The main objective of this study is to verify the hypothesis that pubertal development , obesity , body satisfaction , as well as family and peer influences predict unhealthy eating habits in children and adolescents . A r and omized stratified sample of young Quebecers aged 9 , 13 , and 16 years on March 31 , 1999 [ 608 children aged of 9 years ( 325 girls and 283 boys ) and 662 adolescents aged of 13 and 16 years ( 349 girls and 313 boys ) ] were used . Children 's weight , height , and Body Mass Index ( BMI ) were recorded . Question naires were administered to children and a parent ( usually the mother ) . Among 9-year-old children , this study found that weight loss or weight control behaviors were predicted mainly by the onset of puberty , lower maternal abusive control , and the level of peer pressure . Among adolescents , mother 's BMI , income , peer pressure , and negative comments about the child 's weight most strongly predicted behaviors to control weight , strategies to lose weight and the frequency of such behaviors . The findings suggest that both parents and children need to underst and the impact of comments on a child 's behavior"
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41173d36-06ff-11f0-808a-c43d1ab1c353
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Low selenium status is associated with increased risk of Graves ' disease ( GD ) . While several trials have discussed the efficacy of selenium supplementation for thyroid function , in GD patients , the effectiveness of selenium intake as adjuvant therapy remains unclear . In this systematic review and meta- analysis , we aim ed to determine the efficacy of selenium supplementation on thyroid function in GD patients . Two review ers search ed PubMed , Web of Science , the Cochrane Central Register of Controlled Trials , and four Chinese data bases for studies published up to October 31 , 2017 . RCTs comparing the effect of selenium supplementation on thyroid hyperfunction in GD patients on antithyroid medication to placebo were included . Serum free thyroxine ( FT4 ) , free triiodothyronine ( FT3 ) , thyrotrophic hormone receptor antibody ( TRAb ) , and thyroid-stimulating hormone ( TSH ) levels were assessed . Ten trials involving 796 patients were included . R and om-effects meta-analyses in weighted mean difference ( WMD ) were performed for 3 , 6 , and 9 months of supplementation and compared to placebo administration . Selenium supplementation significantly decreased FT4 ( WMD=-0.86 [ confidence interval (CI)-1.20 to -0.53 ] ; p=0.756 ; I2=0.0 % ) and FT3 ( WMD=-0.34 [ CI-0.66 to -0.02 ] ; p=0.719 ; I2=0.0 % ) levels at 3 months , compared to placebo administration ; these findings were consistent at 6 but not 9 months . TSH levels were more elevated in the group of patients taking selenium than in the control group at 3 and 6 , but not 9 months . TRAb levels decreased at 6 but not 9 months . At 6 months , patients on selenium supplementation were more likely than controls to show improved thyroid function ; however , the effect disappeared at 9 months . Whether these effects correlate with clinical ly relevant measures remains to be demonstrated
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"The effect of selenium supplementation on recurrent hyperthyroidism caused by Graves ' disease is unclear . Our study aim ed to assess the efficacy of selenium supplementation therapy on recurrent Graves ' disease . Forty-one patients with recurrent Graves ' disease were enrolled in this study . All patients received the routine treatment using methimazole ( MMI ) , while patients allocated to the selenium group received additional selenium therapy for 6 months . The influence of selenium supplementation on the concentrations of thyroid stimulating hormone ( TSH ) , anti-TSH-receptor antibodies ( TRAb ) , free thyroxine ( FT4 ) , and free triiodothyronine ( FT3 ) were assessed . The remission rate was also compared between 2 groups . There was no obvious difference in the demographic data and the levels of serum FT4 , FT3 , TSH , and TRAb between the 2 groups at baseline . Both FT4 and FT3 decreased more at 2 months in the selenium group than the controls , while the TSH level increased more in patients receiving selenium supplementation ( p TRAb level was significantly lower in patients receiving selenium supplementation ( 2.4 IU/l vs. 5.6 IU/l , p=0.04 ) . The percentages of patients with normal TRAb level at 6 months was also significantly higher in the selenium group ( 19.0 vs. 0 % , p=0.016 ) . Kaplan-Meier survival curve showed patients receiving selenium supplementation had a significantly higher rate of remission than controls ( Log-rank test p=0.008 ) . In conclusion , selenium supplementation can enhance the effect of antithyroid drugs in patients with recurrent Graves ' disease . R and omized trials with large number of participants are needed to vali date the finding above",
"Context : Supplemental selenium ( Se ) may affect the clinical course of Graves disease ( GD ) . Objective : Evaluate efficacy of add‐on Se on medical treatment in GD . Design : Double‐blind , placebo‐controlled , r and omized supplementation trial . Setting : Academic endocrine outpatient clinic . Patients : Seventy untreated hyperthyroid patients with GD . Intervention : Additionally to methimazole ( MMI ) , patients received for 24 weeks either sodium selenite 300 & mgr;g/d po or placebo . MMI was discontinued at 24 weeks in euthyroid patients . Main Outcome Measures : Response rate ( week 24 ) , recurrence rate ( week 36 ) , and safety . Results : A response was registered in 25 of 31 patients ( 80 % ) and in 27 of 33 ( 82 % ) at week 24 [ odds ratio ( OR ) 0.93 ; 95 % confidence interval ( CI ) , 0.26 to 3.25 ; P = 0.904 ] in the Se ( + MMI ) and placebo ( + MMI ) groups , respectively . During a 12‐week follow‐up , 11 of 23 ( 48 % ) and 12 of 27 ( 44 % ) relapsed ( OR 1.13 ; 95 % CI , 0.29 to 2.66 ; P = 0.81 ) in the Se and placebo groups , respectively . Serum concentrations of Se and selenoprotein P were unrelated to response or recurrence rates . At week 36 , 12 of 29 ( 41 % ) and 15 of 33 ( 45 % ) were responders and still in remission in the Se and placebo groups , respectively ( OR 0.85 ; 95 % CI , 0.31 to 2.32 ; P = 0.80 ) . Serum levels of free triiodothyronine/free tetraiodothyronine , thyroid‐stimulating hormone receptor antibody , prevalence of moderate to severe Graves orbitopathy , thyroid volume , and MMI starting dose were significantly lower in responders than in nonresponders . A total of 56 and 63 adverse events occurred in the Se and placebo groups , respectively ( P = 0.164 ) , whereas only one drug‐related side effect ( 2.9 % ) was noted in 35 patients on placebo + MMI . Conclusions : Supplemental Se did not affect response or recurrence rates in GD",
"Introduction : In areas with severe selenium deficiency higher incidence of thyroiditis has been reported due to a decreased activity of selenium-dependent glutathione peroxidase enzyme within thyroid cells . Aims and Objective : To study the effect of selenium supplementation in patients with autoimmune thyroid disease . Material s and Methods : This is a blinded placebo-controlled prospect i ve study done in 60 patients with autoimmune thyroid disease ( as defined by an anti-thyroid peroxidase antibody ( TPOAb ) level more than 150 IU/ml ) irrespective of the baseline thyroid status . Patients with overt hyperthyroidism who are on antithyroid drugs , patients on any other medication , which may alter the immunity status of the patients , and pregnant patients were excluded from the study . Patients were r and omized into two age and TPOAb-matched groups ; 30 patients received 200 μg of sodium selenite/day , orally , for 3 months , and 30 patients received placebo . All hypothyroid patients were given l-thyroxine replacement . Results : Of 30 patients in the selenium treated group , 6 patients were overtly hypothyroid , 15 were sub clinical hypothyroid , 6 were euthyroid , and 3 were sub clinical hyperthyroid . The mean TPOAb concentration decreased significantly by 49.5 % ( P Conclusion : Selenium substitution has a significant impact on inflammatory activity in thyroid-specific autoimmune disease . It would be of interest to determine whether early treatment with selenium in patients with newly developed autoimmune thyroiditis may delay or even prevent the natural course of these diseases",
"Increased reactive oxygen species ( ROS ) generation and the consequent oxidative damage are involved in the development of several diseases , including autoimmune diseases . Graves ’ disease is an autoimmune disorder characterized by hyperthyroidism and , less frequently , orbitopathy . Hyperthyroidism is characterized by increased oxidative stress . Untreated hyperthyroidism is associated with an increase of several parameters of oxidative stress and in most studies ( but not all ) by an increase of antioxidant defense enzymes . Restoration of euthyroidism with antithyroid drug is associated with a reversal of the biochemical abnormalities associated with oxidative stress . Animal and human studies suggest that increased ROS may directly contribute to some clinical manifestation of the disease , including orbitopathy . Antioxidants administered alone improve some clinical signs and symptoms of hyperthyroidism and , when associated with antithyroid drugs , induce a more rapid control of clinical manifestations and a faster achievement of euthyroidism . A large r and omized clinical trial has shown that antioxidant supplementation ( selenium ) may also be beneficial for mild Graves ’ orbitopathy",
"Objective In spite of previous conflicting results , an adjuvant role of selenium in the treatment of Graves ’ disease ( GD ) hyperthyroidism has been proposed . To address this issue , a r and omized clinical trial was carried out aim ed at investigating whether selenium is beneficial on the short-term control of GD hyperthyroidism treated with methimazole ( MMI ) . Methods Thirty newly diagnosed hyperthyroid GD patients were r and omly assigned to treatment with : ( i ) MMI or ( ii ) MMI plus selenium . Primary outcomes were : control of hyperthyroidism and clinical and biochemical manifestations of hyperthyroidism [ heart rate , cholesterol , sex hormone-binding globulin ( SHBG ) , hyperthyroidism symptoms ] at 90 days . Results Baseline features of the two groups did not differ . Serum selenium at baseline was similar in the two groups and within the recommended range to define selenium sufficiency . Selenium increased with treatment in the MMI-selenium group and became significantly higher than in the MMI group . Serum malondialdehyde , a marker of oxidative stress , was similar in the two groups and decreased significantly with treatment , with no difference between groups . Administration of MMI was followed by a reduction of FT3 and FT4 , with no difference between groups . Heart rate , SHBG and symptoms of hyperthyroidism decreased , whereas total cholesterol increased in both groups with no difference between groups . Conclusions Our study , carried out in a selenium-sufficient cohort of GD patients , failed to show an adjuvant role of selenium in the short-term control of hyperthyroidism . However , selenium might be beneficial in patients from selenium-deficient areas , as well as in the long-term outcome of antithyroid treatment",
"BACKGROUND Recent clinical studies have demonstrated the suppressive effect of selenium ( Se ) treatment on serum thyroid-specific antibody titers in patients with autoimmune thyroiditis ( AIT ) , but the mechanism underlying this process is not clear . The aim of the present study was to investigate the effects of selenium on the incidence and severity of AIT , titers of thyroid autoantibodies , and selenoprotein expression in thyroid in a spontaneous autoimmune thyroiditis ( SAT ) model . METHODS NOD.H-2(h4 ) mice at four weeks of age were r and omly divided into control , iodine supplement ( SAT ) , and selenium supplement groups ( SAT+Se ) . Mice were given 0.005 % sodium iodide water for eight weeks to induce SAT and then 0.3 mg/L sodium selenite in drinking water for 8 weeks and 16 weeks . The severity of lymphocytic infiltration in the thyroid , serum thyroglobulin antibody ( TgAb ) titers , serum selenium concentration , expression of glutathione peroxidase-1 ( GPx1 ) , thioredoxin reductase-1 ( Txnrd1 ) , and peroxiredoxin 5 were measured . RESULTS Serum selenium concentration significantly increased after selenium supplementation . Serum TgAb levels were significantly lower in the selenium group compared with the SAT group ( p prevalence of thyroiditis and the degree of infiltration of lymphocytes decreased gradually over time in the group provided with selenium supplementation . The expression of GPx1 and Txnrd1 by Western blotting were found to be significantly higher in the SAT+Se group than in other groups ( p selenium treatment can increase the function of antioxidation by upregulating the expression of selenoproteins in the thyroid and have an inhibitory effect on TgAb titers , which may have an impact on AIT",
"Oxidative stress plays an important role in hyperthyroidism-induced tissue damage , as well as in development of autoimmune disorders . To clarify influence of thyroid metabolic status and autoimmune factors on blood extracellular indices of reactive oxygen species ( ROS ) generation and free radical scavenging in hyperthyroidism , we studied patients with newly diagnosed and untreated Graves ' disease without infiltrative ophthalmopathy ( 17 female and 8 male , aged 41.8±8.9 ) and toxic multinodular goiter ( 15 female and 9 male , aged 48.4±10.1 ) under the same antithyroid treatment protocol . Initially and after achievement of stable euthyroidism with methimazole , plasma levels of hydrogen peroxide ( H2O2 ) , lipid hydroperoxides ( ROOH ) and ceruloplasmin ( CP ) and serum concentrations of thiobarbituric acid-reacting substances ( TBARS ) were determined . Similarly , activities of plasma superoxide dismutase ( SOD ) , catalase ( CAT ) , glutathione peroxidase ( GPx ) and glutathione reductase ( GR ) were assayed . The results were compared to those of age- and sex-matched controls . Average duration of hyperthyroidism and treatment period were similar in both patients groups . H2O2 , ROOH and TBARS concentrations were significantly higher in hyperthyroid patients compared to controls . Hyperthyroidism caused an evident increase in SOD and CAT activities and CP level , as well as a decrease in GPx and GR activities . Achievement of euthyroidism result ed in normalization of all analyzed parameters in both hyperthyroid patients groups . These findings suggest that the changes in blood extracellular indices of oxidative stress and free radical scavenging in hyperthyroid patients are influenced by thyroid metabolic status , and are not directly dependent on autoimmune factors present in Graves ' disease",
"Background : In Graves ' thyrotoxicosis tachycardia , weight loss and mental symptoms are common . Recovery takes time and varies between patients . Treatment with methimazole reduces thyroid hormone levels . According to previous research , this reduction has been faster if selenium ( Se ) is added . Objective : The objective was to investigate whether supplementing the pharmacologic treatment with Se could change the immune mechanisms , hormone levels and /or depression and anxiety . Methods : We prospect ively investigated 38 patients with initially untreated thyrotoxicosis by measuring the thyroid-stimulating hormone ( TSH ) , free thyroxine ( FT4 ) , free triiodothyronine ( FT3 ) , thyroid receptor antibodies and thyroid peroxidase auto-antibodies before medication and at 6 , 18 and 36 weeks after commencing treatment with methimazole and levo-thyroxine , with a r and omized blinded oral administration of 200 µg Se/day or placebo . The selenoprotein P concentration was determined in plasma at inclusion and after 36 weeks . The patients were also assessed with question naires about depression , anxiety and self-rated symptoms before medication was started and after 36 weeks . Results : FT4 decreased more in the Se group at 18 weeks ( 14 vs. 17 pmol/l compared to the placebo group , p = 0.01 ) and also at 36 weeks ( 15 vs. 18 pmol/l , p = 0.01 ) . The TSH increased more in the Se group at 18 weeks ( 0.05 vs. 0.02 mIU/l , p = 0.04 ) . The depression and anxiety scores were similar in both groups . In the Se group , the depression rates correlated negatively with FT3 and positively with TSH . This was not seen in the placebo group . Conclusions : Se supplementation can enhance biochemical restoration of hyperthyroidism , but whether this could shorten clinical symptoms of thyrotoxicosis and reduce mental symptoms must be investigated further"
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41173d72-06ff-11f0-808a-c43d1ab1c353
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β-Blockers are less effective than other antihypertensive drug classes in reducing central systolic blood pressure ( cSBP ) as compared with peripheral SBP ( pSBP ) . Whether this effect is less pronounced with vasodilating β-blockers ( VBB ) when compared with nonvasodilating β-blockers ( NVBB ) remains unsettled . We conducted a systematic review and meta- analysis of r and omized trials exploring the effects of β-blockers on both pSBP and cSBP in hypertension . We selected 20 studies , for a total of 32 treatment arms ( n=21 for NVBB , n=11 for VBB ) and 1263 participants ( n=962 for NVBB , n=301 for VBB ) . pSBP decreased from 150 to 133 mm Hg for NVBB and from 145 to 134 mm Hg for VBB . cSBP decreased from 137 to 126 mm Hg for NVBB and from 132 to 123 mm Hg for VBB . SBP amplification ( pSBP-cSBP ) decreased significantly under VBB ( -5.6 mm Hg ; 95 % confidence interval , -7.8 , -3.4 mm Hg ) , but not under NVBB ( -1.1 mm Hg ; 95 % confidence interval , -3.4 , + 1.2 mm Hg ; P changes in SBP amplification between NVBB and VBB lost its significance after adjustment for mean age and baseline pSBP and heart rate ( -2.9±2.3 mm Hg ; P=0.22 ) and was almost abolished after adjustment for treatment-induced heart rate changes ( -0.1±0.5 mm Hg ; P=0.78 ) . In conclusion , NVBBs , but not VBBs , determine a lower reduction in cSBP than in pSBP . However , the difference in treatment-induced SBP amplification changes between NVBB and VBB is nearly abolished after accounting for differences in heart rate changes
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"Background The aim of this study was to compare the antihypertensive efficacy of losartan 100 mg + hydrochlorothiazide ( HCTZ ) 25 mg versus bisoprolol 10 mg + HCTZ 25 mg and their influence on arterial stiffness and central blood pressure ( BP ) . Methods Of 60 patients with a mean BP of 173.3 ± 1.7/98.4 ± 1.2 mmHg , 59 were r and om-ized to losartan + HCTZ ( n = 32 ) or bisoprolol + HCTZ ( n = 27 ) . Amlodipine was added if target BP was not achieved at 1 month , and doxazosin was added if target BP was not achieved after 3 months . Body mass index , office and 24-hour ambulatory BP , pulse wave velocity ( carotid-femoral [ PWVE ] and radial [ PWVM ] ) , noninvasive central systolic BP , augmentation index ( AIx ) , laboratory investigations , and electrocardiography were done at baseline and after 6 months of treatment . Results Losartan + HCTZ was as effective as bisoprolol + HCTZ , with target office BP achieved in 96.9 % and 92.6 % of patients and target 24-hour BP in 75 % and 66.7 % of patients , respectively , after 6 months . Effective treatment of BP led to significant lowering of central systolic BP , but this was decreased to a significantly ( P by losartan + HCTZ ( −23.0 ± 2.3 mmHg ) than by bisoprolol + HCTZ ( −15.4 ± 2.9 mmHg ) despite equal lowering of brachial BP . Factors correlated with central systolic BP and its lowering differed between the treatment groups . Losartan + HCTZ did not alter arterial stiffness patterns significantly , but bisoprolol + HCTZ significantly increased AIx . We noted differences in ΔPWVE , ΔPWVM , and ΔAIx between the groups in favor of losartan + HCTZ . Decreased heart rate was associated with higher central systolic BP and AIx in the bisoprolol + HCTZ group , but was not associated with increased AIx in the losartan + HCTZ group . Conclusion Although both treatments decreased both office and 24-hour BP , losartan + HCTZ significantly decreased central systolic BP and had a more positive influence on pulse wave velocity , with a less negative effect of decreased heart rate on AIx and central systolic BP ",
"Isolated systolic hypertension is an important risk factor for cardiovascular disease and results primarily from elastic artery stiffening . Although various drug therapies are used to lower peripheral blood pressure ( BP ) in patients with isolated systolic hypertension , the effects of the 4 major classes of antihypertensive agents on central BP , pulse pressure ( PP ) amplification , and arterial stiffness in this condition are not clear . Fifty-nine patients over the age of 60 years with untreated isolated systolic hypertension ( systolic BP ≥140 mm Hg and diastolic BP ≤90 mm Hg ) were r and omly assigned to receive 1 of the following 4 antihypertensive agents : perindopril , atenolol , lercanidipine , or bendrofluazide . BP was measured using a mercury sphygmomanometer , and augmentation index and carotid-femoral ( aortic ) pulse wave velocity were measured at baseline , after 2 weeks of placebo therapy , and at the end of 10 weeks of active therapy . Peripheral systolic BP and peripheral PP were reduced similarly after treatment with all 4 classes of drug . However , central PP was only reduced significantly by perindopril , lercanidipine , and bendrofluazide , whereas atenolol had no effect . Lercanidipine reduced the augmentation index , whereas atenolol increased it . Aortic pulse wave velocity was not changed by any of the drugs . In summary , despite similar reductions in peripheral systolic and PPs with the 4 classes of drug , changes in central pressure and augmentation index varied . Because central PP and increased wave reflections are considered important risk factors in patients with isolated systolic hypertension , the choice of therapy may be influenced by these findings in the future",
"Objective β-blockers ( BBs ) with different pharmacological properties may have heterogeneous effects on sympathetic nervous activity ( SNA ) and central aortic pressure ( CAP ) , which are independent cardiovascular factors for hypertension . Hence , we analyzed the effects of bisoprolol and atenolol on SNA and CAP in hypertensive patients . Methods This was a prospect i ve , r and omized , controlled study in 109 never-treated hypertensive subjects r and omized to bisoprolol ( 5 mg ) or atenolol ( 50 mg ) for 4–8 weeks . SNA , baroreflex sensitivity ( BRS ) and heart rate ( HR ) variability ( HRV ) were measured using power spectral analysis using a Finometer . CAP and related parameters were determined using the SphygmoCor device ( pulse wave analysis ) . Results Both drugs were similarly effective in reducing brachial BP . However , central systolic BP ( −14±10 mm Hg vs −6±9 mm Hg ; P ) and aortic pulse pressure ( −3±10 mm Hg vs + 3±8 mm Hg ; P with bisoprolol than with atenolol . The augmentation index at a HR of 75 bpm ( AIxatHR75 ) was significantly decreased ( 29%±11 % to 25%±12 % ; P = 0.026 ) in the bisoprolol group only . Furthermore , the change in BRS in the bisoprolol group ( 3.99±4.19 ms/mmHg ) was higher than in the atenolol group ( 2.66±3.78 ms/mmHg ) , although not statistically significant ( P>0.05 ) . BRS was stable when RHR was controlled ( RHR≤65 bpm ) , and the two treatments had similar effects on the low frequency/high frequency ( HF ) ratio and on HF . Conclusion BBs seem to have different effects on arterial distensibility and compliance in hypertensive subjects . Compared with atenolol , bisoprolol may have a better effect on CAP . Trial Registration Clinical Trials.gov",
"We compared dilevalol ( an isomer of labetalol ) , 200 - 400 mg daily , against atenolol , 50 - 100 mg daily , in a double-blind , crossover , placebo-controlled trial with respect to effects on arterial distensibility ( measured as pulse wave velocity [ PWV ] ) and wave reflection ( assessed from carotid pressure wave contour ) . Twelve patients of mean age 58 years ( range 44 - 73 years ) with essential hypertension ( supine diastolic blood pressure 95 - 114 mm Hg ) took active therapy for 12 weeks , separated by a 2 - 4 week placebo period . Carotid pressure waveforms were recorded noninvasively by applanation tonometry with a Millar micromanometer-tipped probe . PWV was measured between carotid and femoral arteries ( aortic PWV ) , carotid and radial arteries ( arm PWV ) , and femoral and pedal arteries ( leg PWV ) . Early wave reflection was calculated from the ratio of the height of the peak of the carotid wave above its shoulder to the pulse pressure and was expressed as an augmentation index . Both drugs were equally effective in reducing brachial sphygmomanometric pressure and PWV in all three regions ( active vs. placebo , p less than 0.001 ) , but there was no significant difference between the two active therapies . However , the augmentation index ( averaged during the treatment period ) was significantly lower with dilevalol ( 19 % ) than with atenolol ( 28 % , p less than 0.01 ) , corresponding to a greater decrease of 5 - 8 mm Hg in carotid systolic pressure compared with the brachial artery . Although both drugs were equally effective in reducing arterial distensibility , the vasodilating action of dilevalol gave added benefit in reducing wave reflection , presumably through its vasodilatory effect on peripheral conduit arteries",
"BACKGROUND Different blood pressure (BP)-lowering drugs could have different effects on central aortic pressures and thus cardiovascular outcome despite similar effects on brachial BP . The Conduit Artery Function Evaluation ( CAFE ) study , a sub study of the Anglo-Sc and inavian Cardiac Outcomes Trial ( ASCOT ) , examined the impact of 2 different BP lowering-regimens ( atenolol+/-thiazide-based versus amlodipine+/-perindopril-based therapy ) on derived central aortic pressures and hemodynamics . METHODS AND RESULTS The CAFE study recruited 2199 patients in 5 ASCOT centers . Radial artery applanation tonometry and pulse wave analysis were used to derive central aortic pressures and hemodynamic indexes on repeated visits for up to 4 years . Most patients received combination therapy throughout the study . Despite similar brachial systolic BPs between treatment groups ( Delta0.7 mm Hg ; 95 % CI , -0.4 to 1.7 ; P=0.2 ) , there were substantial reductions in central aortic pressures with the amlodipine regimen ( central aortic systolic BP , Delta4.3 mm Hg ; 95 % CI , 3.3 to 5.4 ; P pulse pressure , Delta3.0 mm Hg ; 95 % CI , 2.1 to 3.9 ; P central pulse pressure was significantly associated with a post hoc-defined composite outcome of total cardiovascular events/ procedures and development of renal impairment in the CAFE cohort ( unadjusted , P central aortic pressures and hemodynamics despite a similar impact on brachial BP . Moreover , central aortic pulse pressure may be a determinant of clinical outcomes , and differences in central aortic pressures may be a potential mechanism to explain the different clinical outcomes between the 2 BP treatment arms in ASCOT",
"Antihypertensive agents may , even within the same class , exert variable effects on arterial stiffness variables . Nebivolol could have a better impact than atenolol on arterial stiffness , by increasing the bioavailability of endothelium-derived nitric oxide . Angiotensin-converting enzyme inhibitors ( ACEIs ) and angiotensin receptor blockers ( ARBs ) increase plasma renin activity ( enhancing the production of angiotensin II via non-ACE-related pathways ) whereas aliskiren does not , potentially affecting central hemodynamics differently . We compared the effects of two renin-angiotensin-aldosterone system ( RAAS ) inhibitors ( quinapril and aliskiren ) and 2 beta-blockers ( atenolol and nebivolol ) on arterial stiffness variables . Treatment-naïve patients ( n = 72 ; 68.1 % males ; age , 47.6 ± 10.6 years ) with uncomplicated stage I-II essential hypertension were r and omly assigned to quinapril , aliskiren , atenolol , or nebivolol for 10 weeks . Central systolic and diastolic blood pressure ( BP ) , central pulse pressure ( PP ) , augmentation index ( AIx ) , and pulse wave velocity ( PWV ) were measured at baseline , 2 , and 10 weeks . The same measurements were performed in 20 normotensive subjects ( 65.0 % males ; age , 40.0 ± 8.9 years ) . Peripheral and central systolic and diastolic BP , peripheral PP , and PWV were significantly and similarly reduced by all agents . However , PWV continued to decline between the second and last visit in patients on quinapril and aliskiren but did not change in those on nebivolol or atenolol . Central PP and AIx decreased in patients on quinapril , aliskiren , and nebivolol but did not change in those taking atenolol . The decrease in central PP and AIx did not differ between patients on quinapril , aliskiren , and nebivolol . Despite similar reductions in peripheral BP , atenolol is less effective than nebivolol and RAAS inhibitors in improving central pulsatile hemodynamics . Aliskiren exerts similar effects on markers of arterial stiffness as quinapril . The clinical relevance of these differences remains to be established",
"Background . Hypertension is common after liver transplantation . There are few published data on optimum treatment . Augmentation index ( AIx ) is a measure of arterial wave reflection determined by pulse wave analysis . Methods . Amlodipine was administered to 24 hypertensive liver transplant recipients . Thirteen patients intolerant of or unresponsive to amlodipine were r and omized to a crossover study comparing bisoprolol with lisinopril . Results . With amlodipine , systolic blood pressure ( SBP ) fell from 154±2 mm Hg to 130±2 mm Hg , and AIx also fell . With bisoprolol , SBP fell from 154±2 mm Hg to 142±4 mm Hg , but AIx increased . With lisinopril , SBP fell from 154±2 mm Hg to 130±5 mm Hg , and AIx also fell ( P Amlodipine is an effective treatment for hypertension . The increased AIx with bisoprolol indicates increased wave reflection such that central aortic pressure is reduced less than peripheral SBP . Lisinopril reduces AIx and reduces SBP more than bisoprolol and is the preferred drug",
"1 . In arterial hypertension , aortic wave reflections contribute to determining central systolic and pulse pressures . The present study assessed the central pressure alterations at the level of the common carotid artery following 1 month treatment with perindopril or atenolol and investigated during the 8 h following drug intake",
"Objectives Some β-blockers are less effective in reducing central blood pressure than other antihypertensive drugs , which may explain the higher rate of events in subjects r and omized to atenolol in recent trials . We hypothesized that nebivolol , a mixed β-blocker/nitro-vasodilator , would be more effective than atenolol in reducing central blood pressure and augmentation index ( AIx ) . The aim of the present study was to test this in a double-blind , r and omized , cross-over study , in a cohort of subjects with isolated systolic hypertension . Methods Following a 2-week placebo run-in , 16 never-treated hypertensive subjects received atenolol ( 50 mg ) , nebivolol ( 5 mg ) and placebo , each for 5 weeks , in a r and om order . Seated brachial blood pressure and heart rate were measured . Aortic blood pressure , AIx and pulse wave velocity ( PWV ) were assessed non-invasively . Results The placebo-corrected fall in brachial pressure was similar between nebivolol and atenolol , as was the reduction in PWV ( mean change ± SEM : −1.0 ± 0.3 and −1.2 ± 0.2 m/s ; P = 0.2 ) . However , there was less reduction in heart rate ( −19 ± 2 versus −23 ± 2 beats/min ; P increase in AIx ( + 6 ± 1 versus + 10 ± 1 % ; P = 0.04 ) , following nebivolol . Aortic pulse pressure was significantly lower ( 50 ± 2 versus 54 ± 2 mmHg ; P = 0.02 ) after nebivolol . N-terminal pro-B-type natriuretic peptide ( proBNP ) rose on both drugs ( 100 ± 33 versus 75 ± 80 pg/ml ; P Conclusions Nebivolol and atenolol have similar effects on brachial blood pressure and aortic stiffness . However , nebivolol reduces aortic pulse pressure more than atenolol , which may be related to a less pronounced rise in AIx and bradycardia . Whether this will translate into differences in clinical outcome requires further investigation",
"Renin – angiotensin system ( RAS ) blockers have shown clinical outcomes superior to those of the beta (β)-blocker atenolol , despite similar reductions in the peripheral blood pressure ( BP ) , perhaps because of different impacts on central hemodynamics . However , few comparative studies of RAS blockers and newer vasodilating β-blockers have been performed . We compared the central hemodynamic effects of losartan and carvedilol in a prospect i ve , r and omized , open , blinded end point study . Of the 201 hypertensive patients enrolled , 182 ( 49.6±9.9 years , losartan group=88 and carvedilol group=94 ) were analyzed . Carotid-femoral pulse wave velocity ( cfPWV ) , aortic augmentation index ( AIx ) , AIx corrected for a heart rate ( HR ) of 75 beats per minute ( AIx@HR75 ) and central BP were measured noninvasively at baseline and after a 24-week treatment regimen with losartan or carvedilol . After 24 weeks , there were no between-group differences in the brachial BP , cfPWV , AIx@HR75 or central BP changes , except for a more favorable AIx effect with losartan . The changes in all measured metabolic and inflammatory parameters were also not significantly different between the two groups , except for uric acid . Losartan and carvedilol showed generally comparable effects on central hemodynamic indices , metabolic profile , inflammatory parameters and peripheral arterial pressure with a 24-week treatment",
"Objective . Angiotensin-converting enzyme ( ACE ) inhibitors have been shown to lower central augmentation index ( cAI ) , an index of arterial wave reflection , more than β-blockers . We tested whether this is also true for long-term treatment with an angiotensin receptor blocker ( ARB ) . Methods . One-hundred and fifty-six subjects with essential hypertension were r and omised to treatment with either irbesartan or atenolol . cAI and central blood pressure ( BP ) were determined by pulse wave analysis from the radial and the carotid artery after six and after 18 months treatment . Results . Peripheral and central systolic and diastolic BP were reduced to a similar extent A in the two groups . cAI was reduced with irbesartan , but increased with atenolol ( derived from the carotid artery : -6±10 vs. -4±12 % after six months , p . Furthermore , central to peripheral pulse pressure ( PP ) amplification was unaffected by treatment with irbesartan , but decreased with atenolol . Conclusions . Although treatment with irbesartan and atenolol similarly decreased peripheral and central BP , only treatment with irbesartan had beneficial effects on arterial wave reflection and preserved PP amplification . These haemodynamic effects may at least partly explain the reported differential effects of ARB versus β-blocker treatment on cardiovascular mortality in patients with essential hypertension",
"The & bgr;-blocker atenolol is less effective than angiotensin-receptor blockers and calcium-channel blockers for reducing central blood pressure ( BP ) . The trial was design ed to determine whether the advantages of angiotensin-receptor blockers over atenolol remained significant when both were combined with the calcium-channel blocker amlodipine . A prospect i ve , r and omized , blinded endpoint ( PROBE design ) parallel group , multicenter trial including 393 patients with essential hypertension resistant to 4 weeks of 5 mg of amlodipine was set out . Central systolic BP , augmentation index ( AIx ; either rough or adjusted on heart rate ) , and carotid-to-femoral pulse wave velocity were measured with applanation tonometry ( SphygmoCor ) at inclusion and after 8 and 24 weeks of active treatment with an amlodipine-valsartan combination ( 5/80 mg and then 10/160 mg ) or an amlodipine-atenolol combination ( 5/50 mg and then 10/100 mg ) . From baseline to week 24 , central systolic BP decreased significantly more in the amlodipine-valsartan group ( −13.70±1.15 mm Hg ; P amlodipine-atenolol group ( −9.70±1.10 mm Hg ; P changes in brachial systolic BP . The difference in rough AIx reduction was −6.5 % ( 95 % CI : −8.3 to −4.7 ; P amlodipine-valsartan . AIx adjusted on heart rate was significantly reduced in favor of amlodipine-valsartan ( −2.8 % [ 95 % CI : −4.92 to −0.68 ] ; P decreased significantly more with amlodipine-atenolol ( difference : −11 bpm [ 95 % CI : −14 to −8 bpm ] ; P decreased by 0.95 m/s in both groups with no significant difference . Differences in central systolic BP and rough AIx remained significant after adjustment to the changes in heart rate . The amlodipine-valsartan combination decreased central ( systolic and pulse ) pressure and AIx more than the amlodipine-atenolol combination",
"International guidelines recommend that antihypertensive drug therapy should normalize not only diastolic ( DBP ) but also systolic blood pressure ( SBP ) . Therapeutic trials based on cardiovascular mortality have recently shown that SBP reduction requires normalization of both large artery stiffness and wave reflections . The aim of the present study was to compare the antihypertensive effects of the very-low-dose combination indapamide ( 0.625 mg ) and perindopril ( 2 mg ) ( Per/Ind ) with the & bgr;-blocking agent atenolol ( 50 mg ) to determine whether Per/Ind decreases SBP and pulse pressure ( PP ) more than does atenolol and , if so , whether this decrease is predominantly due to reduction of aortic pulse wave velocity ( PWV ) ( automatic measurements ) and reduction of wave reflections ( pulse wave analysis , applanation tonometry ) . In a double-blind r and omized study , 471 patients with essential hypertension were followed for 12 months . For the same DBP reduction , Per/Ind decreased brachial SBP ( −6.02 mm Hg ; 95 % confidence interval , −8.90 to −3.14 ) and PP ( −5.57 ; 95 % confidence interval , −7.70 to −3.44 ) significantly more than did atenolol . This difference was significantly more pronounced for the carotid artery than for the brachial artery . Whereas the 2 antihypertensive agents decreased PWV to a similar degree , only Per/Ind significantly attenuated carotid wave reflections , result ing in a selective decrease in SBP and PP . The very-low-dose combination Per/Ind normalizes SBP , PP , and arterial function to a significantly larger extent than does atenolol , a hemodynamic profile that is known to improve survival in hypertensive population s with high cardiovascular risk",
"Objective In hypertension , blockade of the renin – angiotensin system reduces left ventricular mass ( LVM ) independently of brachial systolic ( S ) , diastolic ( D ) , and mean ( M ) blood pressure ( BP ) . From central to peripheral arteries , MBP and DBP are practically unchanged , whereas SBP and pulse pressure ( PP ) increase significantly . The objective was to determine whether changes in LVM under drug treatment was preferentially associated with changes in central or brachial SBP and PP . Design A sub study of 146 subjects was selected from 469 hypertensive patients su bmi tted to a double-blind r and omized trial comparing the combination of perindopril ( 2 mg ; Per ) and indapamide ( 0.625 mg ; Ind ) with atenolol ( 50 mg , one tablet per day ) . Main outcome measures Before and after 1 year of treatment : LVM ( echocardiography ) in 146 subjects and , in 52 of them , central ( carotid ) BP and timing of wave reflections ( tonometry ) . Results LVM changes were significantly associated with antihypertensive treatment , with lower LVM with Per/Ind than with atenolol . Changes in SBP and PP , but not in MBP and DBP , were more significantly associated with Per/Ind than with atenolol , with more pronounced effects using central than brachial measurements , and a longer delay in central return of wave reflections under Per/Ind . In the sampling of 52 patients with tonometry , the change in LVM between the two drug regimens was significantly linked to central , but not brachial , PP change . Conclusions This observational study shows a lower LVM under Per/Ind than under atenolol . The greater change in LVM on Per/Ind was linked to central and not brachial blood pressure",
"The aim of this study was to investigate the effects of the vasodilating & bgr;-blocker nebivolol and the cardioselective & bgr;-blocker metoprolol succinate on aortic blood pressure and left ventricular wall thickness . We conducted a r and omized , double-blind study on 80 hypertensive patients . The patients received either 5 mg of nebivolol or 50 to 100 mg of metoprolol succinate daily for 1 year . Their heart rate , central and brachial blood pressures , mean arterial pressure , augmentation index , carotid-femoral pulse wave velocity , and left ventricular wall thickness were measured at baseline and at the end of the study . Nebivolol and metoprolol significantly reduced heart rate , brachial blood pressure , and mean arterial pressure to the same degree . However , reductions in central systolic and diastolic blood pressures , central pulse pressure , and left ventricular wall thickness were significant only in the nebivolol group . The change in left ventricular septal wall thickness was significantly correlated with central systolic blood pressure change ( r=0.41 ; P=0.001 ) and with central pulse pressure change ( r=0.32 ; P=0.01 ) . No significant changes in augmentation index or carotid-femoral pulse wave velocity were detected in either treatment group . This proof-of-principle study provides evidence to suggest that & bgr;-blockers with vasodilating properties may offer advantages over conventional & bgr;-blockers in antihypertensive therapy ; however , this remains to be tested in a larger trial",
"BACKGROUND Blood pressure reduction achieved with beta-blockers and diuretics is the best recorded intervention to date for prevention of cardiovascular morbidity and death in patients with hypertension . Left ventricular hypertrophy ( LVH ) is a strong independent indicator of risk of cardiovascular morbidity and death . We aim ed to establish whether selective blocking of angiotensin II improves LVH beyond reducing blood pressure and , consequently , reduces cardiovascular morbidity and death . METHODS We did a double-masked , r and omised , parallel-group trial in 9193 participants aged 55 - 80 years with essential hypertension ( sitting blood pressure 160 - 200/95 - 115 mm Hg ) and LVH ascertained by electrocardiography ( ECG ) . We assigned participants once daily losartan-based or atenolol-based antihypertensive treatment for at least 4 years and until 1040 patients had a primary cardiovascular event ( death , myocardial infa rct ion , or stroke ) . We used Cox regression analysis to compare regimens . FINDINGS Blood pressure fell by 30.2/16.6 ( SD 18.5/10.1 ) and 29.1/16.8 mm Hg ( 19.2/10.1 ) in the losartan and atenolol groups , respectively . The primary composite endpoint occurred in 508 losartan ( 23.8 per 1000 patient-years ) and 588 atenolol patients ( 27.9 per 1000 patient-years ; relative risk 0.87 , 95 % CI 0.77 - 0.98 , p=0.021 ) . 204 losartan and 234 atenolol patients died from cardiovascular disease ( 0.89 , 0.73 - 1.07 , p=0.206 ) ; 232 and 309 , respectively , had fatal or non-fatal stroke ( 0.75 , 0.63 - 0.89 , p=0.001 ) ; and myocardial infa rct ion ( non-fatal and fatal ) occurred in 198 and 188 , respectively ( 1.07 , 0.88 - 1.31 , p=0.491 ) . New-onset diabetes was less frequent with losartan . Interpretation Losartan prevents more cardiovascular morbidity and death than atenolol for a similar reduction in blood pressure and is better tolerated . Losartan seems to confer benefits beyond reduction in blood pressure",
"Acute & bgr;-adrenergic blockade increases aortic wave reflection ; however , the mechanisms remain unclear . Evidence suggests that & bgr;-adrenergic receptor sensitivity in the peripheral vasculature differs between sexes . Therefore , the goal of this study was to examine whether & bgr;-adrenergic blockade alters aortic wave reflection to a similar extent in young men and women . In 31 subjects ( 16 men and 15 women ; 26±1 years ) noninvasive aortic pressure waveforms were synthesized from high-fidelity radial pressure waveforms via applanation tonometry before and during systemic & bgr;-blockade ( 0.25 mg/kg bolus , followed by 0.004 mg/kg per minute of continuous infusion of propranolol ) . & bgr;-Blockade increased aortic augmentation index and wave reflection amplitude ( aortic augmented pressure ) in both sexes ( P the increase in augmentation index was not significantly different between sexes ( 7.5±1.1 % versus 4.6±1.5 % ; P=0.07 ) , the increase in aortic augmented pressure was greater in women compared with men ( 2.8±0.5 versus 1.4±0.5 mm Hg ; P ) . Aortic augmentation index adjusted for a heart rate of 75 bp increased in women ( 4.1±1.1 % ; P the change in aortic augmentation index was inversely associated with the change in heart rate only in men ( r=−0.54 ; P that aortic wave reflection is increased to a greater extent in women after systemic & bgr;-blockade , and enhanced aortic wave reflection appears to be mediated by a reduced heart rate in men , whereas the mechanism is unclear in women",
"There is little information about the hemodynamic and exercise-response implication s of renin-angiotensin system blocker combinations . After a 3-week lisinopril ( L ; 40 mg/day ) run-in , carvedilol ( C ; 20 then 40 mg/day ) or valsartan ( V ; 160 then 320 mg/day ) was added to L for 4 weeks each in a forced-titration , r and om order-entry crossover study in 30 subjects . Arterial tonometry ( central pressures and time-tension index , TTI ) ; impedance cardiography ( steady-state hemodynamics ) , and ultrasound ( carotid flow ) were performed at rest and during supine bicycle exercise at 30 and 60 watts . At rest , both V and C lowered TTI similarly ( 7 % to 9 % , P = .05 compared with L , in part because they lowered blood pressure ( 3 to 7/3 to 4 mm Hg ) . V lowered central systolic pressure , augmentation pressure ( AP ) , and systemic vascular resistance ( SVR , all P ) ; C lowered heart rate but not central systolic pressure or SVR . During exercise , V persistently lowered central systolic pressure , AP , and SVR , whereas C did not . Neither drug affected exercise responses or carotid blood flow . Adding V or C to an angiotensin-converting enzyme inhibitor reduced cardiac workload by different mechanisms : vasodilation and reduced central blood pressure with V and lower heart rate with",
"Background : The vasodilating beta-blocker nebivolol is thought to be superior in lowering wave reflection and central blood pressure ( BP ) compared to nonvasodilating beta-blockers . The results from studies comparing nebivolol with either metoprolol or atenolol , with or without hydrochlorothiazide ( HCTZ ) , are not unequivocal . Methods : We examined the effects of nebivolol 5 mg and metoprolol 100 mg with HCTZ 12.5 mg on aortic wave augmentation , central BP and hemodynamics using a r and omized , double-blind , crossover design . We included 22 patients ( 17 men , age 59.9 ± 6.4 years ) with office SBP of 155 ± 16 mmHg and DBP of 93 ± 10 mmHg . Radial applanation tonometry and noninvasive , continuous finger arterial BP measurement was performed at baseline and after 4 weeks of treatment with either drug regimen , separated by a 4-week washout period . Results : Neither treatment affected aortic wave augmentation significantly . Augmentation index increased 1.0 ± 7.8 % ( P = 0.5 ) for nebivolol/HCTZ and 2.4 ± 6.6 % ( P = 0.07 ) for metoprolol/HCTZ . Nebivolol/HCTZ lowered central SBP by 15.8 ± 14.9 mmHg and DBP 10.5 ± 8.4 mmHg , and with metoprolol/HCTZ by 13.5 ± 12.3 mmHg for SBP and 9.5 ± 6.8 mmHg for DBP ( all P rate was lowered 8.1 ± 5.4 beats/min by nebivolol/HCTZ and 8.6 ± 4.9 beats/min by metoprolol/HCTZ . Peripheral BP was reduced to a similar extent as central BP . Peripheral BP decreased by 16.3 ± 14.9 mmHg systolic and 10.1 ± 8.2 mmHg diastolic with nebivolol/HCTZ , and by 15.2 ± 13.0 mmHg systolic and 9.1 ± 6.9 mmHg diastolic with metoprolol/HCTZ . Both treatment modalities had a similar effect on stroke volume , cardiac output , left-ventricular contractility and peripheral resistance . Conclusion : Nebivolol was not superior to metoprolol in reducing aortic wave augmentation or central BP when combined with HCTZ",
"The beneficial effects of nebivolol on arterial stiffness and endothelial dysfunction are well documented in untreated hypertensive patients and differ from nonvasodilatory β-blockers . This study tests the hypothesis that the addition of nebivolol in predominantly African American patients with type 2 diabetes already receiving maximally tolerated doses of renin-angiotensin system ( RAS ) blockers will further improve large artery compliance . Patients with type 2 diabetes and hypertension on maximal RAS blockade ( n=70 ) were r and omized to nebivolol or metoprolol succinate daily . Doses were titrated until systolic blood pressure ( SBP ) was derive central aortic pressures and hemodynamic indices at repeated visits at intervals during a 6-month period . Both metoprolol succinate and nebivolol groups demonstrated reductions in brachial SBP ( -8.2±4.3 mm Hg [ P=.01 ] and -7.8±3.7 [ P=.002 ] , respectively ) and aortic DBP ( -2.4±1.8 [ P=.039 ] and -4.0±2.9 mm Hg [ P=.013 ] , respectively ) . Aortic SBP decreased in the nebivolol group only ( 125.3±8 to 121.6±8.2 , P=.025 ) . There were no between group differences in aortic SBP , DBP , augmentation index , or PWV reduction . A significant increase in hemoglobin A1c was observed only in the metoprolol group . In patients with well-controlled type 2 diabetes and hypertension treated with maximally tolerated RAS blockade , nebivolol does not offer significant reductions in aortic BP over metoprolol succinate but maintains a stable metabolic profile",
"BACKGROUND Recent data suggest that atenolol may be inferior to other antihypertensive drugs in reducing cardiovascular risk in older individuals with hypertension , despite lowering peripheral blood pressure ( BP ) . We hypothesized that that atenolol fails to reduce central BP as much as other agents . The aim of the present study was to compare the hemodynamic effects of atenolol and eprosartan in a double-blind , r and omized , cross-over study . METHODS After a 2-week placebo run-in , 21 subjects with never-treated hypertension underwent 6 weeks of therapy with atenolol ( 50 mg ) and eprosartan ( 600 mg ) . Central BP and augmentation index were assessed using pulse wave analysis , and aortic pulse wave velocity was measured , at baseline and at the end of each treatment . RESULTS Both drugs reduced peripheral BP to the same degree . However , there was a significantly greater reduction in central systolic BP with eprosartan ( means + /- SEM : 16 + /- 3 v 11 + /- 2 mm Hg ; P = .03 ) . Despite identical reductions in mean pressure , atenolol reduced aortic pulse wave velocity more than eprosartan ( 0.8 + /- 0.1 v 0.5 + /- 0.1 m/sec ; P = .005 ) . Conversely , augmentation index and N-terminal pro-brain natiuretic peptide levels were reduced significantly after eprosartan ( 6 % + /- 2 % and 11 + /- 5 pg/mL , respectively ) but were increased after atenolol ( 7 % + /- 2 % and 67 + /- 24 pg/mL , respectively ) . CONCLUSIONS These data indicate that despite similar effects on peripheral BP and a greater effect on aortic stiffness , atenolol had less impact on central systolic BP than eprosartan because it failed to reduce wave reflection . This provides one potential explanation for the failure of atenolol to improve outcome in older patients with essential hypertension",
"Blood pressure ( BP ) characteristics , such as central aortic pressure and arterial stiffness , independently predict cardiovascular events . The effects of pharmacologically dissimilar β-blockers on these properties have not been fully eluci date d. Patients with essential hypertension and without significant concomitant cardiovascular disease were r and omly assigned to controlled-release carvedilol , force-titrated to 80 mg ( n=22 ) , or atenolol , force-titrated to 100 mg ( n=19 ) ; each was given once daily for 4 weeks . Baseline characteristics were similar . At the end of week 4 , atenolol and carvedilol reduced central and brachial systolic and diastolic BP to a similar extent . Central augmentation index was increased in atenolol-treated patients but not carvedilol-treated patients ( atenolol 4.47 % vs carvedilol -0.68 % ; P=.04 ) . Mean augmented central aortic pressure increased slightly during atenolol treatment ( + 1.1 mm Hg ) but decreased slightly during carvedilol treatment ( -1.1 mm Hg ) , although the difference in these changes was not statistically significant ( P=.23 ) . Pulse pressure amplification was reduced more with atenolol at week 4 ( atenolol -10.7 % vs carvedilol -1.8 % ; P=.02 ) . Therefore , we conclude that carvedilol results in more favorable pulse pressure amplification and augmentation index by increasing arterial compliance and reducing the magnitude of wave reflection , respectively , compared with atenolol",
"We conducted this study to compare the effects of fosinopril versus atenolol on peripheral blood pressure , central arterial wave reflection , and left ventricular mass in a group of patients with essential hypertension . We conducted a double-blind , r and omized trial of fosinopril and atenolol in 79 hypertensive patients ( 52 men , 27 women ; mean age , 45.8 + /- 8.5 years ; range , 30 to 68 years ) . Carotid pressure waveforms were recorded noninvasively by applanation tonometry with a Millar micromanometer-tipped probe . The extent of wave reflection was estimated by the augmentation index defined as the ratio of the amplitude of pressure wave above its systolic shoulder to the pulse pressure . The augmentation index , left ventricular mass index by two-dimensional echocardiography , and 24-hour ambulatory blood pressures were determined before and after 8 weeks of daily treatment with fosinopril ( 10 to 20 mg ) or atenolol ( 50 to 100 mg ) with or without diuretics and compared with those values in 79 normotensive control subjects . After 8 weeks of treatment , both drugs lowered 24-hour ambulatory peripheral systolic and diastolic pressures into the normal range to a similar extent ( fosinopril , -18/-13 mm Hg ; atenolol , -23/-17 mm Hg , both P = NS ) . On the other h and , whereas the elevated augmentation index in hypertensive patients compared with normotensive subjects ( 16 + /- 11 % versus 10 + /- 8 % ) was completely normalized by fosinopril ( -9.3 + /- 9.8 % , P atenolol ( -4.8 + /- 8.9 % , P ( fosinopril versus atenolol effect , P = .04 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Pulse pressure ( PP ) , a marker of arterial stiffness , predicts cardiovascular risk . We aim ed to determine whether augmentation pressure ( AP ) derived from the aortic pressure waveform predicts major adverse cardiovascular events ( MACE ) and death independently of PP in patients with established coronary artery disease ( CAD ) . We prospect ively followed-up 297 males undergoing coronary angiography for 1186±424 days . Ascending aortic pressure tracings obtained during catheterization were used to calculate AP ( difference between the second and the first systolic peak ) . Augmentation index ( AIx ) was defined as AP as a percentage of PP . We evaluated whether AP and AIx can predict the risk of MACE ( unstable angina , acute myocardial infa rct ion , coronary revascularization , stroke , or death ) and death using Cox regression . All models evaluating AP included PP to assess whether AP adds to the information already provided by PP . Both AP and AIx significantly predicted MACE . The hazard ratio ( HR ) per 10 mm Hg increase in AP was 1.20 ( 95 % confidence interval [ CI ] , 1.08 to 1.34 ; P predictors of MACE , age , and other potential confounders , AP remained a significant predictor of MACE ( HR per 10 mm Hg increase=1.19 ; 95 % CI , 1.06 to 1.34 ; P=0.002 ) , as did AIx ( adjusted HR , 1.28 ; 95 % CI , 1.09 to 1.50 ; P=0.003 ) . AP was a significant predictor of death ( HR per 10 mm Hg increase=1.18 ; 95 % CI , 1.02 to 1.39 ; P=0.03 ) . Higher AIx was associated with a trend toward increased mortality ( HR=1.22 ; 95 % CI , 0.98 to 1.52 ; P=0.056 ) . Aortic AP predicts adverse outcomes in patients with CAD independently of PP and other risk markers",
"BACKGROUND Sodium nitroprusside ( SNP ) and labetalol are recommended for the immediate treatment of malignant hypertension . Both are intravenous agents but have different effects on systemic hemodynamics , and may have differential effects on pulse-wave reflection and pulse-pressure amplification , with consequences for peripheral versus central blood pressures ( BPs ) . METHODS We conducted a nonr and omized , open-label study of 8 patients treated with sodium nitroprusside ( mean age ( ±SD ) , 44±14 years ; 6 males ; diastolic/systolic BP , 225±22/135±8 mm Hg ) and 6 patients treated with intravenous labetalol ( mean age , 39±15 years ; 4 males ; systolic/diastolic BP , 232±22/138±17 mm Hg ) before and after treatment for malignant hypertension , aim ing at a 25 % reduction in mean arterial pressure . We measured peripheral pressures with an intra-arterial catheter in the radial artery and derived central pressures with a generalized transfer filter . RESULTS Mean arterial pressure was similarly reduced with sodium nitroprusside and labetalol ( by 27 % and 30 % , respectively ; P = 0.76 ) . There was a nonsignificantly greater reduction in peripheral systolic blood pressure ( SBP ) with labetalol than with sodium nitroprusside ( 29±11 % vs. 18±7 % , P = 0.08 ) . The decline in peripheral diastolic blood pressure ( DBP ) with the two agents was comparable , whereas the reduction in peripheral pulse pressure was 8±16 % with SNP and 33±17 % with labetalol ( P = 0.01 ) . The decline in reflection magnitude was greater with SNP than with labetalol . There were no significant differences in the reduction of central BP with SNP and labetalol . The amplification of PP increased with SNP but did not change with labetalol . CONCLUSIONS We found no difference in central SBP or PP in subjects treated with SNP and labetalol , but labetalol produced a greater reduction in peripheral SBP and PP in the immediate treatment of malignant hypertension",
"The aim of the current study was to characterize the effects of the novel β-adrenergic antagonist nebivolol on central aortic blood pressures , arterial properties , and nitroxidergic activity in individuals with prehypertension . Prehypertension is emerging as a major risk factor for several adverse cardiovascular consequences . Increased pulse wave velocity , aortic augmentation index , and aortic blood pressures have been linked with augmented risk of cardiovascular disease and mortality . While the effects of antihypertensive drugs on these parameters in hypertensive patients have been studied , there are limited data so far in prehypertension . Fifty individuals with prehypertension were r and omized to either nebivolol ( 5 mg per day ) or placebo in a double-blind clinical trial . Patients underwent measurement of pulse wave velocity as well as aortic blood pressure and aortic augmentation index via pulse wave analysis at baseline and 8 weeks . Patients also had blood and urine biochemistries done at each visit . Nebivolol achieved significant reductions in central aortic systolic ( P=.011 ) , diastolic ( P=.009 ) , and mean arterial blood pressure ( P=.002 ) . Pulse wave velocity trended toward improvement but did not achieve significance ( P=.088 ) . Nitric oxide production , measured as urinary nitrite/nitrite excretion , also rose substantially in the nebivolol group ( by approximately 60 % , P=.030 ) . Central blood pressures can be effectively lowered by β-blockade while patients are still in the prehypertension phase , and the effects may be coupled to improve nitric oxide release by the drug",
"BACKGROUND We tested the hypothesis that celiprolol and bisoprolol have differential effects on blood pressure ( BP ) , flow-mediated dilation ( FMD ) , and vascular stiffness . METHODS We analyzed 102 hypertensives ( mean age : 59±14 years ) who were being treated other than beta-blockers . They were r and omized to receive add-on treatment with either celiprolol 100 - 200 mg ( C group ) or bisoprolol 2.5 - 5 mg ( B group ) , and followed up for 3 months . In addition to clinic , home , and ambulatory BP monitoring , the FMD , radial augmentation index ( AI ) , brachial-ankle pulse wave velocity ( baPWV ) , urine albumin-to-creatinine ratio , and baroreflex sensitivity ( BRS ) were measured at baseline and at the end of the study . RESULTS Compared to the baseline values , home and 24-hour BP were significantly lowered in the third month in both groups ( all Ps 0.05 ) . Pulse rate ( PR ) and baPWV were reduced ( P ) , and BRS was increased significantly only in the B group ( P = 0.02 ) . Radial AI was unchanged in the C group but was significantly increased in the B group ( P 0.001 ) . Central BP was significantly reduced in the C group ( P = 0.003 ) but was unchanged in the B group . FMD was significantly increased in both groups ( both P CONCLUSION Bisoprolol achieved the greater reduction of PR and improved BRS and vascular stiffness , whereas , celiprolol reduced the central BP level . In treated hypertensive patients , add-on use of celiprolol may be favorable in uncomplicated stage of hypertension . On the other h and , bisoprolol may be useful in hypertensives with cardiac or vascular diseases who have advanced atherosclerotic changes and sympathetic nervous system activation ",
"BACKGROUND Local pulse pressure ( PP ) is an independent determinant of carotid artery wall thickness , stronger than mean blood pressure ( BP ) . The present study was design ed to assess whether a beta-adrenoceptor antagonist-based or an ACE inhibitor-based treatment was able to reduce carotid artery wall hypertrophy through a reduction in carotid PP rather than by lowering mean BP and whether the influence of local PP reduction could also be detected at the site of a muscular artery , the radial artery . METHODS AND RESULTS Ninety-eight essential hypertensive patients were r and omized to 9 months of double-blind treatment with either celiprolol or enalapril . Arterial parameters were determined with high-resolution echo-tracking systems . PP was measured locally with applanation tonometry and independently of mean BP . After 9 months of treatment , mean BP , carotid PP , and intimal-medial thickness ( IMT ) decreased significantly , with no difference between the 2 groups . The reduction in carotid PP but not in mean BP was a major independent determinant of the reduction in carotid IMT . Radial artery IMT and PP decreased significantly with both treatments . However , the reduction in radial artery IMT was not related to the changes in radial artery PP . CONCLUSIONS The regression of carotid artery wall hypertrophy during long-term antihypertensive treatment was dependent on the reduction in local PP rather than on the lowering of mean BP . The effect of PP lowering on IMT reduction was observed at the site of an elastic artery but not at the site of a muscular artery",
"OBJECTIVES The goal of this study was to determine if a low-dose combination of the angiotensin-converting enzyme inhibitor perindopril ( Per ) and the diuretic indapamide ( Ind ) reduces central ( thoracic aorta , carotid artery ) as well as brachial systolic blood pressure ( SBP ) more than the beta-blocker atenolol and to determine the hemodynamic factors influencing independently brachial and central SBP : pulse wave velocity ( PWV ) and pattern of wave reflections . BACKGROUND In high cardiovascular risk population s , angiotensin blockade improves survival without affecting brachial SBP and diastolic blood pressure ( DBP ) . Whether central SBP , which is physiologically lower than brachial SBP , is significantly reduced has never been investigated . METHODS This study was a double-blind r and omized trial for one year in patients with essential hypertension . RESULTS For a similar DBP reduction , Per/Ind decreased SBP significantly more than atenolol , with a more pronounced reduction for central than for brachial SBP . After one year , the difference between brachial and central SBP was maintained by Per/Ind ( 8.28 + /- 1.53 mm Hg ) and significantly attenuated by atenolol ( 0.29 + /- 1.61 mm Hg ) . Under atenolol , the principal factor modulating SBP reduction was mean blood pressure . Under Per/Ind , this parameter played a minor role , and the central SBP reduction implied a major role for disturbed PWV and wave reflections . CONCLUSIONS Under Per/Ind , but not atenolol , normalization of brachial SBP is achieved with a significantly greater reduction of central SBP . This hemodynamic profile reflects changes of wave reflections issued from distal arterial and arteriolar territory , where Per/Ind , but not atenolol , is known to improve vessel wall structure",
"In this prospect i ve , open-label , r and omized , controlled clinical trial the effects of low-dose carvedilol , nebivolol , and metoprolol on central arterial pressure and augmentation index ( AIx ) and its heart rate-corrected value ( AIx@75 ) were assessed . The authors r and omized 75 hypertensive patients ( 18 - 70 years ) to carvedilol 12.5/25 mg , metoprolol 50/100 mg , or nebivolol 2.5/5 mg daily and followed them up for 3 months . Central arterial pressure and AIx were measured with applanation tonometry at baseline and at the end of follow-up . Analyses were restricted to 60 completers . Central systolic pressure decreased equally in all 3 treatment arms . AIx remained unchanged , while AIx@75 decreased significantly by 5.4%±2.5 % in the nebivolol group . According to general linear models , individual change in heart rate was a strong predictor of change in AIx in the carvedilol group ( r(2 ) = 0.23 , P=.03 ) although no similar association was found in the nebivolol group ( r(2 ) = 0.09 ) . The impact of β-blockers with vasodilator effects on pressure augmentation seems to be different with nebivolol having the largest potential of decreasing AIx@75 . While AIx changes associated with carvedilol treatment are strongly driven by heart rate changes , those associated with nebivolol treatment seem to be the result of other mechanisms",
"Abstract Introduction . The main objective was to compare the mean change in augmentation index of hypertensive patients treated with nebivolol or atenolol . Methods . Multicenter , double-blind r and omized study conducted in six Spanish centers . We enrolled out patients between the ages of 40 and 65 years with mild or moderate essential hypertension ( systolic blood pressure , SBP ≥ 140 mmHg to ≤ 179 mmHg and diastolic blood pressure , DBP ≥ 90 mmHg to ≤ 109 mmHg after a 2-week run-in placebo period ) . Patients received nebivolol 5 mg or atenolol 50 mg once daily . At week 3 , atenolol could be titrated up to 100 mg qd for non-responders . Additionally , patients not achieving normal blood pressure after 6 weeks could be treated with 25 mg hydrochlorothiazide . Follow-up visits were at 3 , 6 and 10 weeks . Results . The final study population of 138 patients ( 58 % men ; median age 52.6 years , range 40–67 years ) was r and omized into two groups of 69 patients each . Baseline characteristics of the two groups were similar . At the screening visit , 69 % presented with mild hypertension . Nebivolol modified the mean augmentation index to a lesser extent than atenolol after 10 weeks ( mean difference 3.1 % , 95 % CI 0.55–5.69 ; p = 0.027 ) . A higher proportion of patients in the atenolol group required a diuretic . Reductions in central aortic pressure and peripheral arterial pressure were similar for both treatment groups . Conclusions . The study confirms that nebivolol produces a less pronounced impact on augmentation index than atenolol ",
"Objective The substantial benefits of ramipril over conventional therapy in high-risk patients are not always associated with clinical ly significant differences in brachial arterial pressure , and largely remain unexplained . We undertook this acute study to establish the magnitude of and reason for different acute effects of ramipril and atenolol on arterial pressure . Methods We enrolled 30 patients , who took 10 mg ramipril , 100 mg atenolol , and placebo at intervals of ≥ 7 days , in a r and omized , double-blind , placebo-controlled trial . After baseline , measurements were taken at 30–60 min intervals for 5 h , and comprised cuff brachial pressure , radial artery tonometry with generation of central aortic pressure , and pulse wave velocity for aorta , upper limb and lower limb arteries . Results Both ramipril and atenolol reduced arterial pressure , and the diastolic pressure fall was similar in the aorta and brachial artery , but the systolic pressure fall for ramipril was greater than for atenolol ( by 5.2 mmHg , P The aortic systolic pressure difference with ramipril in comparison with atenolol was accompanied by an absolute difference of 10.7 % ( P ramipril . The aortic pulse wave velocity fell to a similar degree with ramipril in comparison with atenolol , but fell to a greater degree ( 1.35 and 0.44 m/s , respectively , P in aortic systolic pressure caused by ramipril may explain the greater benefit of ramipril over atenolol . The difference is attributable to decreased stiffness of peripheral arteries and a reduction in wave reflection",
"BACKGROUND Aortic dilatation is the main therapeutic target in patients with Marfan syndrome . St and ard treatment with a β-blocker may not lower central pulse pressure - the major objective - because it does not do so in hypertension , unlike angiotensin-converting enzyme inhibitors and calcium-channel blockers . We therefore performed a prospect i ve , r and omised , double-blind , crossover trial to compare the effects of these three agents on large artery function and central aortic pressure in patients with Marfan syndrome . METHODS AND RESULTS Eighteen patients had applanation tonometry , pulse wave analysis and echocardiography , before and after atenolol 75 mg , perindopril 4 mg and verapamil 240 mg , each given for 4 weeks , in a r and om order , with 2 weeks between medications . Fourteen patients completed the study . Within-drug comparisons demonstrated that perindopril ( -10·3 mmHg , P = 0·002 ) , verapamil ( -9·2 mmHg , P = 0·003 ) and atenolol ( -7·1 mmHg , P = 0·01 ) all reduced central systolic pressure and brachial pressure ; central changes were least , and peripheral changes greatest with atenolol but between-drug comparisons ( analysis of covariance ) were not significant . There was a trend for augmentation to be reduced by perindopril ( -6·3 % , P = 0·05 ) , verapamil ( -5·5 % , P = 0·07 ) and atenolol ( -3·2 % , P = 0·09 ) . Only atenolol reduced heart rate ( by 16 % ) and delayed expansion in the arch and abdominal aorta ( by 8 % and 11 % ) ( P CONCLUSIONS Perindopril , verapamil and atenolol all reduced peripheral and central systolic pressure . As atenolol slowed heart rate and delayed aortic wave travel , β-blockade may have a continuing role in the treatment of patients with Marfan syndrome",
"BACKGROUND There is conflicting information with regard to the effect of beta-blockers on arterial stiffness and wave reflection . We compared a vasodilating beta-blocker , nebivolol , with atenolol . METHODS We r and omized 40 subjects with untreated hypertension ( mean + /- s.e.m . systolic/diastolic blood pressure ( BP ) of 160 + /- 3/98 + /- 1 mm Hg , age 49 + /- 1 years ) 16 of whom were women , to atenolol 50 mg or nebivolol 5 mg daily for 4 weeks . Arterial stiffness was assessed in terms of carotid-femoral pulse wave velocity ( PWV , Complior ) and arterial wave reflection ( augmentation index ( AIx ) by applanation tonometry , Sphygmocor ) . RESULTS Both beta-blockers produced an equal reduction in brachial BP but aortic pulse pressure ( PP ) was reduced to a greater extent by nebivolol ( P PWV was decreased significantly by both therapies ( nebivolol : from 11.5 + /- 0.5 to 9.9 + /- 0.5 m/s ; atenolol : from 11.1 + /- 0.4 to 9.8 + /- 0.4 m/s ; P nebivolol significantly reduced AIx ( from 35 + /- 5 to 28 + /- 2 % , P PP amplification ( PP , mm Hg ) decreased with atenolol therapy ( from 10 + /- 1 to 7 + /- 1 , P Atenolol reduced heart rate to a greater extent than nebivolol did ( 14 + /- 3/min reduction by atenolol vs. 8 + /- 2/min reduction by nebivolol , P transit time . CONCLUSION The beta-blockers , atenolol and nebivolol , have a similar effect in reducing arterial stiffness in the large elastic aorta , largely secondary to BP reduction . Nebivolol , in contrast to atenolol , has an effect on small muscular arteries , increasing PP amplification and reducing wave reflection , possibly because of increased levels of nitric oxide ( NO ) . Such ancillary properties may impart important distinct hemodynamic effects , and therefore beta-blockers can not be regarded as a homogeneous group",
"Objective : The results from the ASCOT CAFÉ study demonstrated the inferiority of beta blockers in reducing central aortic blood pressure . In this study , we wanted to demonstrate whether or not second-generation beta blockers with higher beta 1 selectivity , namely bisoprolol , may counterbalance the effect of bradycardia through reduced reflection wave magnitude result ing from the relative lack of increase in peripheral vascular resistance . Method : This was a prospect i ve , r and omized , open-label , active-controlled trial in 209 hypertensive patients to evaluate the effect of bisoprolol and atenolol on aortic pulse pressure . Patients received a once-daily 5 mg dose of bisoprolol ( n = 96 ) or 50 mg dose of atenolol ( n = 95 ) at baseline with titration up to bisprolol 10 mg and atenolol 100 mg allowed at the 4th week when the brachial blood pressure was above treatment goal ( average dose : bisoprolol : 5.4 mg , atenolol : 52.8 mg ) . Central blood pressure and augmentation index were measured at baseline and 12 weeks later , by pulse wave analysis with radial artery tonometry . The primary endpoint of the study was the difference in the central pulse pressure ( CPP ) at 12 weeks . Results : The results showed a significant reduction of CPP in both groups at week 12 of administration compared with the predose level ( P CPP change [ bisoprolol ( baseline CPP 47.49 ± 11.33 , follow-up 43.09 ± 11.67 ) vs. atenolol ( baseline CPP 45.93 ± 11.62 , follow-up 42.23 ± 9.92 ) , P = 0.594 ] . Conclusion : In this study , there was no significant difference between bisoprolol and atenolol in terms of reduction of aortic pulse pressure after 12 weeks of treatment",
"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 Differential effects of beta-adrenoreceptor antagonists ( beta-ARB ) on central and peripheral blood pressure may relate to change in heart rate and /or vasodilator tone and thus be exaggerated during exercise . AIMS To examine acute effects of selective and nonselective beta-ARB on central and peripheral blood pressure , cardiac output and peripheral vascular resistance during exercise . METHODS Healthy volunteers ( n= 20 , 18 men , 19 - 54 years ) received propranolol 80 mg , bisoprolol 20 mg , and placebo 1 h before bicycle ergometry ( 50 , 75 and 100 W each for 3 min ) in a r and omized , cross-over study . Cardiac output was determined by pulmonary uptake of soluble and inert gas tracers ( InnoCor , Innovision ) . Central systolic blood pressure ( SBP ) was determined from the late systolic shoulder of the digital artery pressure waveform ( Finometer , Finopres ) . RESULTS At rest , both beta-ARB reduced brachial but not central SBP ( compared with placebo ) . During exercise , beta-ARB reduced brachial SBP ( reductions of 19.9 + /- 4.3 mmHg and 23.2 + /- 2.7 mmHg for propranolol and bisoprolol , respectively , at 100 W , each P central SBP . The difference between peripheral and central SBP was reduced , relative to that during placebo , by 21.5 mmHg ( 95 % confidence interval 8.8 , 34.1 ) and 26.4 mmHg ( 18.1 , 34.8 ) for propranolol and bisoprolol , respectively , at 100 W ( each P diastolic blood pressure or peripheral vascular resistance . CONCLUSIONS Despite reducing brachial blood pressure , acute beta-adrenoreceptor blockade in man at rest and during exercise does not reduce central blood pressure"
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BACKGROUND Ischaemic heart disease ( IHD ) is a major cause of mortality and morbidity and its prevalence is set to increase . Secondary prevention aims to prevent subsequent acute events in people with established IHD . While the benefits of individual medical and lifestyle interventions is established , the effectiveness of interventions which seek to improve the way secondary preventive care is delivered in primary care or community setting s is less so . OBJECTIVES To assess the effectiveness of service organisation interventions , identifying which types and elements of service change are associated with most improvement in clinician and patient adherence to secondary prevention recommendations relating to risk factor levels and monitoring ( blood pressure , cholesterol and lifestyle factors such as diet , exercise , smoking and obesity ) and appropriate prophylactic medication . SEARCH STRATEGY We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL , The Cochrane Library 2007 , Issue 4 ) , MEDLINE ( 1966 to Feb 2008 ) , EMBASE ( 1980 to Feb 2008 ) , and CINAHL ( 1981 to Feb 2008 ) . Bibliographies were checked . No language restrictions were applied . SELECTION CRITERIA R and omised or quasi-r and omised controlled trials of service organisation interventions in primary care or community setting s in population s with established IHD . DATA COLLECTION AND ANALYSIS Analyses were conducted according to Cochrane recommendations and Odds Ratios ( with 95 % confidence intervals ) reported for dichotomous outcomes , mean differences ( with 95 % CIs ) for continuous outcomes . MAIN RESULTS Eleven studies involving 12,074 people with IHD were included . Increased proportions of patients with total cholesterol levels within recommended levels at 12 months , OR 1.90 ( 1.04 to 3.48 ) , were associated with interventions that included regular planned appointments , patient education and structured monitoring of medication and risk factors , but significant heterogeneity was apparent . Results relating to blood pressure within target levels bordered on statistical significance . There were no significant effects of interventions on mean blood pressure or cholesterol levels , prescribing , smoking status or body mass index . Few data were available on the effect on diet . There was some suggestion of a " ceiling effect " whereby interventions have a diminishing beneficial effect once certain levels of risk factor management are reached . AUTHORS ' CONCLUSIONS There is weak evidence that regular planned recall of patients for appointments , structured monitoring of risk factors and prescribing , and education for patients can be effective in increasing the proportions of patients within target levels for cholesterol control and blood pressure . Further research in this area would benefit from greater st and ardisation of the outcomes measured
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"Background The aim of the SPHERE study is to design , implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease ( CHD ) in general practice across two different health systems on the isl and of Irel and .CHD is a common cause of death and a significant cause of morbidity in Irel and . Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives . Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the isl and of Irel and . The review literature recommends structured programmes with continued support and follow-up of patients ; the provision of training , tailored to practice needs of access to evidence of effectiveness of secondary prevention ; structured recall programmes that also take account of individual practice needs ; and patient-centred consultations accompanied by attention to disease management guidelines . Methods SPHERE is a cluster r and omised controlled trial , with practice -level r and omisation to intervention and control groups , recruiting 960 patients from 48 practice s in three study centres ( Belfast , Dublin and Galway ) . Primary outcomes are blood pressure , total cholesterol , physical and mental health status ( SF-12 ) and hospital re-admissions . The intervention takes place over two years and data is collected at baseline , one-year and two-year follow-up . Data is obtained from medical charts , consultations with practitioners , and patient postal question naires . The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice . It is a multi-faceted intervention that has been developed to respond to barriers and solutions to optimal secondary prevention identified in preliminary qualitative research with practitioners and patients . General practitioners and practice nurses attend training sessions in facilitating behaviour change and medication prescribing guidelines for secondary prevention of CHD . Patients are invited to attend regular four-monthly consultations over two years , during which targets and goals for secondary prevention are set and review ed . The analysis will be strengthened by economic , policy and qualitative components",
"Background Cardiac rehabilitation programs ( CRP ) represent comprehensive interventions that are typically limited to four months . Following completion of CRP , it appears that risk factors and lifestyle behaviours may deteriorate . The Extensive Lifestyle Management Intervention ( ELMI ) Following Cardiac Rehabilitation trial will investigate the benefits of a r and omized intervention to prevent these adverse changes . Methods Patients with ischemic heart disease ( IHD ) were r and omized following a st and ard CRP to the ELMI or to usual care . The ELMI program is a case-managed intervention aim ed at individualizing risk factor and lifestyle management based on current treatment guidelines . The program consists of cardiac rehabilitation sessions , telephone follow-up and risk factor and lifestyle counselling sessions . Health professionals work with participants using behavioural counselling and communications with participants ' family physicians . Usual care participants return to their family physicians ' care , and come to the study clinic only to undergo annual outcomes assessment . The primary outcome is change in IHD global risk after four years . Secondary outcomes include combined cardiovascular events , health care utilization , lifestyle adherence , quality of life and risk factors . Results Over 28 months , 302 men and women were r and omized . This represented 29 % of the total population screened . The average age of study participants is 64 years , 18 % are women , 53 % have had a previous myocardial infa rct ion , 73 % have undergone previous revascularization and 20 % have diabetes mellitus . Ischemic heart disease risk factors for the entire cohort improved significantly after subjects had gone through previous CRPs . Baseline risk factors , lifestyle behaviours and medications were similar between the groups . Conclusions This study population is representative of patients completing a st and ard CRP . Results of the ELMI trial will provide valuable information for the future design of CRPs",
"Abstract Objective : To evaluate the use of a computerised support system for decision making for implementing evidence based clinical guidelines for the management of asthma and angina in adults in primary care . Design : A before and after pragmatic cluster r and omised controlled trial utilising a two by two incomplete block design . Setting : 60 general practice s in north east Engl and . Participants : General practitioners and practice nurses in the study practice s and their patients aged 18 or over with angina or asthma . Main outcome measures : Adherence to the guidelines , based on review of case notes and patient reported generic and condition specific outcome measures . Results : The computerised decision support system had no significant effect on consultation rates , process of care measures ( including prescribing ) , or any patient reported outcomes for either condition . Levels of use of the software were low . Conclusions : No effect was found of computerised evidence based guidelines on the management of asthma or angina in adults in primary care . This was probably due to low levels of use of the software , despite the system being optimised as far as was technically possible . Even if the technical problems of producing a system that fully supports the management of chronic disease were solved , there remains the challenge of integrating the systems into clinical encounters where busy practitioners manage patients with complex , multiple conditions",
"OBJECTIVE To evaluate differences between adults who participated in a secondary prevention of ischaemic heart disease ( IHD ) programme and those who did not . DESIGN Population -based cohort study . SETTING A r and om selection of 12 Irish general practice s. PARTICIPANTS A total of 493 adults with IHD identified in 2000/2001 . INTERVENTION Medical records search and postal question naires in 2000/2001 and 2005/2006 . MAIN OUTCOME MEASURES Differences in demographic characteristics and indicators of process of care and risk factor management between participants and non- participants . RESULTS Multiple logistic regression confirmed that female gender was associated with a reduced likelihood of participation in the secondary prevention programme [ odds ratio ( OR ) 0.53 ( 95 % CI : 0.32 - 0.87 ) ] , while an adequately controlled total cholesterol level was associated with an increased likelihood of enrollment [ OR 1.82 ( 95 % CI : 1.18 - 2.80 ) ] . CONCLUSIONS There is limited evidence that biases , which have been shown to affect participation in research , also affect participation in care programmes in everyday practice . A gender bias appears to have affected the enrollment of participants for the secondary preventive programme considered by this study , with enrollment favouring men with well-managed cholesterol . Reimbursement dependent upon patient adherence may incentivise the enrollment of adherent patients , although the influence of patient choice is unclear : the need to maintain records relating to patients who opt out of such interventions is thus highlighted",
"BACKGROUND Increases in life stress have been linked to poor prognosis , after myocardial infa rct ion ( MI ) . Previous research suggested that a programme of monthly screening for psychological distress , combined with supportive and educational home nursing interventions for distressed patients , may improve post-MI survival among men . Our study assessed this approach for both men and women . We aim ed to find out whether the programme would reduce 1-year cardiac mortality for women and men . METHODS We carried out a r and omised , controlled trial of 1376 post-MI patients ( 903 men , 473 women ) assigned to the intervention programme ( n = 692 ) or usual care ( n = 684 ) for 1 year . All patients completed a baseline interview that included assessment of depression and anxiety . Survivors were also interviewed at 1 year . FINDINGS The programme had no overall survival impact . Preplanned analyses showed higher cardiac ( 9.4 vs 5.0 % , p = 0.064 ) and all-cause mortality ( 10.3 vs 5.4 % , p = 0.051 ) among women in the intervention group . There was no evidence of either benefit or harm among men ( cardiac mortality 2.4 vs 2.5 % , p = 0.94 ; all-cause mortality 3.1 vs 3.1 % , p = 0.93 ) . The programme 's impact on depression and anxiety among survivors was small . INTERPRETATION Our results do not warrant the routine implementation of programmes that involve psychological-distress screening and home nursing intervention for patients recovering from MI . The poorer overall outcome for women , and the possible harmful impact of the intervention on women , underline the need for further research and the inclusion of adequate numbers of women in future post-MI trials",
"INTRODUCTION Our goal was to investigate whether ambulatory smoking cessation among patients in a cardiologic department would ( 1 ) reduce the number of smokers by at least 25 % after 12 months compared to a control group and ( 2 ) influence whether the individual patient was readmitted to hospital . We used a r and omised , controlled , prospect i ve intervention project design . MATERIAL S AND METHODS Everyone hospitalised during the project period was screened . Those who fulfilled the criteria for inclusion were r and omised for inclusion in either the intervention group or the control group . Both groups were given the department 's smoking cessation information . In addition , the intervention group attended five ambulatory smoking cessation intervention sessions . Each patient 's smoking status was registered after 12 months . chi2-test and logistic regression analysis were used to test differences , associations and control of confounders . RESULTS In all , 3,982 patients were screened , 29.5 % of whom were smokers . The study included 105 patients : 54 in the intervention group and 51 in the control group . After 12 months , 52 % of those in the intervention group compared to 39 % in the control group had become non-smokers , which was non-significant ( p = 0,14 ) . Ischemic heart disease ( IHS ) was significantly associated with smoking cessation . After adjustment for this confounder , the result was enhanced ( p = 0,06 ) . Readmission to hospital was not affected by smoking cessation ( p = 0,73 ) . DISCUSSION Ambulatory smoking cessation intervention had no significant effect on smoking cessation on an unselected group of patients in a cardiologic hospital department . The project does indicate that ambulatory smoking cessation interventions could have an effect on patients with IHS",
"BACKGROUND Joint consultation sessions of a small group of general practitioners ( GPs ) and a specialist in orthopaedics proved to be an effective way of decreasing the referral rate of orthopaedic patients . Cardiac complaints comprise an important category of health problems with high referral rates . AIMS To study the effects of joint consultation on the quality of care and referrals for patients with cardiac complaints . DESIGN OF STUDY R and omised controlled trial . SETTING Forty-nine GPs participated in 16 consultation groups , each with one of 13 cardiologists , in monthly joint consultations over a period of about 18 months . METHOD The GPs selected patients about whom they were uncertain , and those needing urgent referral were excluded . Patients were r and omly assigned to joint consultation or to usual care . After a follow-up period all patients had a joint consultation for outcome assessment . Referral data were provided by two regional health insurance companies and question naires were given to the patients , GPs , and cardiologists to gauge their opinion of the trial . RESULTS One hundred and forty-eight patients in the intervention group and 158 patients in the control group fulfilled the whole protocol . The quality of care was similar in both groups . In the intervention group , 34 % of the patients were referred , compared with 55 % in the control group ( P = 0.001 ) , and fewer patients underwent further diagnostic procedures ( 7 % compared with 16 % , P = 0.013 ) . Referrals to cardiology as a proportion of all referrals decreased in the practice s of the participating GPs , compared with their reference districts ( P = 0.024 ) . CONCLUSION Joint consultation is an effective method that provides a quality of care that at least equals usual care and that contributes to a better selection of patients who need specialist care",
"Abstract Objective : To evaluate the effects of secondary prevention clinics run by nurses in general practice on the health of patients with coronary heart disease . Design : R and omised controlled trial of clinics over one year with assessment by self completed postal question naires and audit of medical records at the start and end of the trial . Setting : R and om sample of 19 general practice s in northeast Scotl and . Subjects : 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease who did not have terminal illness or dementia and were not housebound . Intervention : Clinic staff promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures : Health status measured by the SF-36 question naire , chest pain by the angina type specification , and anxiety and depression by the hospital anxiety and depression scale . Use of health services before and during the study . Results : There were significant improvements in six of eight health status domains ( all functioning scales , pain , and general health ) among patients attending the clinic . Role limitations attributed to physical problems improved most ( adjusted difference 8.52 , 95 % confidence interval 4.16 to 12.9 ) . Fewer patients reported worsening chest pain ( odds ratio 0.59 , 95 % confidence interval 0.37 to 0.94 ) . There were no significant effects on anxiety or depression . Fewer intervention group patients required hospital admissions ( 0.64 , 0.48 to 0.86 ) , but general practitioner consultation rates did not alter . Conclusions : Within their first year secondary prevention clinics improved patients ' health and reduced hospital admissions . Key messages Nurse led clinics in general practice were used to promote secondary prevention to patients with coronary heart disease Within the first year the health of patients invited to the clinics improved Most benefit was in functional status , but chest pain improved too There was no effects on anxiety or depression There were significant reductions in hospital admissions in the first",
"INTRODUCTION AND OBJECTIVES To assess the efficacy of cardiac rehabilitation with a mixed primary and cardiological care program in patients with low-risk myocardial infa rct ion . PATIENTS AND METHOD The participants in this 12-month prospect i ve study were 153 consecutive patients with low-risk myocardial infa rct ion ( MI ) referred to their primary care center for follow-up care . Of these patients , 113 were referred to a mixed primary and specialized care program that included physical exercise , cardiovascular risk control , an antismoking program , health education talks and psychological evaluation . The other 40 patients served as controls . We analyzed the results after 3 months and 1 year of follow-up . RESULTS There were no differences between the two groups at baseline . After 1 year , improvements were seen in smoking habit ( 4.6 % vs 15.6 % ; P body mass index ( 26 [ 2 ] vs 29 [ 2 ] ; P Dyslipidemia , glucose and blood pressure were similar in both groups after follow-up . Greater improvements in the group of patients who participated in the program were seen after 1 year in quality of life ( 78 [ 2 ] vs 91 [ 2 ] ; P exercise capacity ( 10.3 [ 2 ] vs 8.4 [ 3 ] ; P return to active employment ( 84.6 % vs 53.3 % ; P cardiac rehabilitation program coordinated by cardiological and primary care services for low-risk post-MI patients improved quality of life , and increased exercise tolerance , active employment , and the number of participants who quit smoking . The mixed program also reduced body mass index . These results suggest the need for similar programs",
"Aim : To compare prognosis for patients with a diagnosis of angina alone to patients postacute myocardial infa rct ion ( AMI ) and /or revascularisation and /or angina . Design : Community-based retrospective cohort study . Setting : A r and om selection of 37 Irish general practice s. Participants : 1,609 adults with ischaemic heart disease ( IHD ) identified in 2000/1 . Intervention : Medical records search es and postal question naires in 2000/1 and 2005/6 . Outcome measures : Primary : all-cause and IHD-related mortality . Secondary : acute myocardial infa rct ion ( AMI ) , cardiac artery bypass grafting ( CABG ) and percutaneous transluminal coronary angioplasty ( PTCA ) ; physical and mental health status as measured by SF36 and SF12 ; process of care measurements and behavioural risk factor outcomes . Results : Compared with patients with previous AMI and /or revascularisation , patients with angina alone had slightly lower risks of all-cause and IHD-related death : however , although hazard ratios of 0.73 ( 95 % CI 0.55 to 0.98 ) and 0.65 ( 95 % CI 0.44 to 0.98 ) , respectively , were significant at the p adjusted risks of subsequent AMI , CABG or PTCA between patients with angina-alone and those with other IHD . Over the 4.5-year follow-up , physical functioning was consistently lower among those with angina alone , and the extent to which physical functioning was increasingly impaired was slightly greater . Conclusions : Prognosis to death or cardiac outcomes for patients with angina alone was similar to those with previous AMI and /or revascularisation , while health status was poorer . The clinical importance of angina should not be underestimated in primary care . Further descriptive research is needed among representative community cohorts of people with angina",
"BACKGROUND This study examined the 1-year effects of a minimal-contact smoking cessation intervention for cardiac in patients . METHODS The multicenter study included cardiac in patients who had smoked prior to hospitalization . A pretest-posttest quasi-experimental design was used . Patients ' experimental condition depended on the hospital they were assigned to . The design was partially r and omized : 4 of the 11 hospitals selected the experimental condition themselves ( 2 experimental , 2 control ) , while the remaining 7 hospitals were r and omly assigned . The experimental group consisted of patients of 5 hospitals ( N = 388 ) . Patients of 6 other hospitals served as the control group ( N = 401 ) . The intervention included stop-smoking advice by the cardiologist , brief counseling by the nurse , the provision of self-help material s , and aftercare by the cardiologist . RESULTS Logistic regression analyses controlling for baseline differences and covariates did not show significant intervention effects on point prevalence and continuous abstinence . The study also showed that the outcomes were not significantly related to the way hospitals were assigned to the experimental condition . CONCLUSIONS While short-term effects were found , the minimal-contact intervention did not result in significant effects after 12 months , at least if patients lost to follow-up were treated as posttest smokers . Efforts should be made to improve the intervention , especially the aftercare",
"Objective To evaluate whether nurse run clinics in general practice improve secondary prevention in patients with coronary heart disease . Design R and omised controlled trial . Setting A r and om sample of 19 general practice s in northeast Scotl and . Patients 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease , but without terminal illness or dementia and not housebound . Intervention Nurse run clinics promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures Components of secondary prevention assessed at baseline and one year were : aspirin use ; blood pressure management ; lipid management ; physical activity ; dietary fat ; and smoking status . A cumulative score was generated by counting the number of appropriate components of secondary prevention for each patient . Results There were significant improvements in aspirin management ( odds ratio 3.22 , 95 % confidence interval 2.15 to 4.80 ) , blood pressure management ( 5.32 , 3.01 to 9.41 ) , lipid management ( 3.19 , 2.39 to 4.26 ) , physical activity ( 1.67 , 1.23 to 2.26 ) and diet ( 1.47 , 1.10 to 1.96 ) . There was no effect on smoking cessation ( 0.78 , 0.47 to 1.28 ) . Of six possible components of secondary prevention , the baseline mean was 3.27 . The adjusted mean improvement attributable to intervention was 0.55 of a component ( 0.44 to 0.67 ) . Improvement was found regardless of practice baseline performance . Conclusions Nurse run clinics proved practical to implement in general practice and effectively increased secondary prevention in coronary heart disease . Most patients gained at least one effective component of secondary prevention and , for them , future cardiovascular events and mortality could be reduced by up to a third",
"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",
"STUDY OBJECTIVE To develop and evaluate a peer review group ( PRG ) meeting using feedback data on a patient level to improve the quality of drug therapy for prevention of recurrent myocardial infa rct ion . DESIGN Prospect i ve follow-up study . DATA SOURCE General practitioners ' computerized patients records ( intervention patients ) and the PHARMO record linkage system ( controls ) . PATIENTS Forty patients in the intervention group and 1030 control patients ; both groups had documented myocardial infa rct ion . INTERVENTION The intervention , which was based on the principles of group academic detailing , consisted of scoring current cardiovascular treatment on separate forms for each patient , presenting an overview of , and discussing , evidence -based treatment after myocardial infa rct ion , defining the target population , formulating a binding consensus , and identifying patients who were eligible for improvement of pharmacotherapy . MEASUREMENTS AND MAIN RESULTS Drug therapy and adherence to the newly formulated PRG consensus were assessed at baseline and 1 year after the intervention . Of the patients who received the intervention and were not treated according to the PRG consensus at baseline , 40 % received treatment according to the consensus 12 months after the PRG meeting . In the control group , the proportion of patients was 9.5 % ( prevalence ratio 4.2 , 95 % confidence interval 1.8 - 9.7 ) . CONCLUSION Peer review group meetings can be a valuable tool for improving pharmacotherapy after myocardial infa rct ion",
"BACKGROUND Despite national efforts to improve cholesterol management for patients with coronary artery disease , many patients are not reaching recommended cholesterol target levels . We sought to determine whether a nurse-based educational intervention , design ed to educate patients with confirmed coronary artery disease about personal low-density lipoprotein ( LDL ) cholesterol target levels and encourage partnership with physicians , could increase adherence with National Cholesterol Education Program target levels ( LDL cholesterol level Patients hospitalized with confirmed coronary artery disease were r and omized to undergo a nurse-based educational intervention ( 375 patients ) or usual care ( 381 patients ) for a 12-month period after hospitalization . The primary outcome was the proportion of patients at the LDL cholesterol target level 1 year after hospitalization . The secondary outcome was the proportion of patients with accurate knowledge of LDL cholesterol target levels . RESULTS The groups were similar at baseline in demographic and clinical characteristics , percent at LDL cholesterol target level ( 43.9 % and 41.1 % , respectively ) , and percent with knowledge of LDL cholesterol target levels ( both 5 % ) . The proportion of patients at LDL cholesterol target levels at 1 year did not differ between the intervention ( 70.2 % ) and usual care group ( 67.4 % , P = .46 ) . At the conclusion of the trial , patient knowledge about LDL cholesterol target level was higher for the intervention group than the usual care group ( 19.6 % and 6.7 % , respectively , P = .001 ) , but this was not associated with improved cholesterol management . CONCLUSIONS Our nurse-based educational intervention did not result in a significant increase in the proportion of patients who reached target LDL cholesterol levels 1 year after hospitalization . Although the intervention improved patient knowledge of LDL cholesterol target levels , overall rates of LDL cholesterol knowledge remained low , and it was not associated with improved cholesterol management",
"OBJECTIVE to examine the effects and feasibility of educating and empowering older people with ischaemic heart disease using trained senior lay health mentors . DESIGN r and omised controlled trial with blinded evaluation . SETTING Falkirk and District Royal Infirmary . PARTICIPANTS in patients and out patients aged 60 or over attending secondary care with a diagnosis of angina or acute myocardial infa rct ion . Three-hundred and nineteen entered and 289 completed exit assessment s. The intervention group took part in mentoring groups for 1 year , meeting monthly for 2 hours , each led by two trained lay health mentors in addition to st and ard care . MAIN OUTCOME MEASURES primary outcome measures were changes in coronary risk factors , medication usage and actual use of secondary care health services . Secondary outcomes were total and cardiovascular events ; changes in medication compliance , non-medical support requirement , health status and psychological functioning , and social inclusion . RESULTS there were significant improvements in a reported current exercise score ( mean + 0.33 , + 0.02 to + 0.52 ) , in the average time spent walking per week by 72 minutes ( + 1 to + 137 minutes ) , and in the SF36 Physical Functioning Score ( + 6.1 , + 2.4 to + 9.5 ) . There was a 1.0 % reduction in total fat ( 95 % CI -3.0 % to -0.6 % ) and a 0.6 % reduction in saturated fat ( 95 % CI -1.5 % to -0.03 % ) . The intervention group showed reduced outpatient attendance for coronary heart disease ( -0.25 appointments , -0.61 to -0.08 ) . Attendance rates were high . Socio-economic grouping did not affect participation . CONCLUSIONS Lay Health Mentoring is feasible , practical and inclusive , positively influencing diet , physical activity , and health re source utilisation in older subjects with ischaemic heart disease without causing harm",
"BACKGROUND Gaps in computerized medical records and a lack of a systematic approach to data recording make progress towards achieving quality st and ards in primary care difficult to demonstrate . The aim of this study was to examine the effect of an educational intervention on data quality in primary care . METHODS A before- and -after study of key data quality measures was carried out in 87 general practice s in eight primary care organizations in Engl and in phase 1 and 84 general practice s in phase 2 . The subjects were 19,470 patients with ischaemic heart disease in phase 1 and 19,784 patients in phase 2 . The main outcome measures were improvement in the completeness and quality of the computerized medical record . Anonymized data were extracted from clinical information systems and processed to produce comparative information on each practice . Data quality workshops were arranged , in which reflection can take place , backed up by summary statistics . Practice visits provided training and personalized feedback of patients needing intervention . RESULTS In the patients with heart disease , nearly 16,000 new clinical entries were made in the key improvement areas . The percentage of patients advised to quit smoking increased by 49.3 per cent , from 23.6 per cent to 61.9 per cent . There were also significant improvements in many other aspects of management . CONCLUSION Focused interventions that provide targeted and relevant clinical information can be implemented in primary care . Such interventions can lead to a rise in data quality in primary care , but their effectiveness needs to be further tested in more rigorous research setting s such as r and omized controlled trials",
"Abstract Objective : To assess the effectiveness of three different methods of promoting secondary prevention of coronary heart disease in primary care . Design : Pragmatic , unblinded , cluster r and omised controlled trial . Setting : Warwickshire . Subjects : 21 general practice s received intervention ; outcome measured in 1906 patients aged 55 - 75 years with established coronary heart disease . Interventions : Audit of notes with summary feedback to primary health care team ( audit group ) ; assistance with setting up a disease register and systematic recall of patients to general practitioner ( GP recall group ) ; assistance with setting up a disease register and systematic recall of patients to a nurse led clinic ( nurse recall group ) . Main outcome measures : At 18 months ' follow up : adequate assessment ( defined ) of 3 risk factors ( blood pressure , cholesterol , and smoking status ) ; prescribing of hypotensive agents , lipid lowering drugs , and antiplatelet drugs ; blood pressure , serum cholesterol level , and plasma cotinine levels . Results : Adequate assessment of all 3 risk factors was much more common in the nurse and GP recall groups ( 85 % , 76 % ) than the audit group ( 52 % ) . The advantage in the nurse recall compared with the audit group was 33 % ( 95 % confidence interval 19 % to 46 % ) ; in the GP recall group compared with the audit group 23 % ( 10 % to 36 % ) , and in the nurse recall group compared with the GP recall group 9 % ( −3 % to 22 % ) . However , these differences in assessment were not reflected in clinical outcomes . Mean blood pressure ( 148/80 , 147/81 , 148/81 mm Hg ) , total cholesterol ( 5.4 , 5.5 , 5.5 mmol/l ) , and cotinine levels ( % probable smokers 17 % , 16 % , 19 % ) varied little between the nurse recall , GP recall , and audit groups respectively , as did prescribing of hypotensive and lipid lowering agents . Prescribing of antiplatelet drugs was higher in the nurse recall group ( 85 % ) than the GP recall or audit groups ( 80 % , 74 % ) . After adjustment for baseline levels , the advantage in the nurse recall group compared with the audit group was 10 % ( 3 % to 17 % ) , in the nurse recall group compared with the GP recall group 8 % ( 1 % to 15 % ) and in the GP recall group compared with the audit group 2 % ( −6 % to 10 % ) . Conclusions : Setting up a register and recall system improved patient assessment at 18 months ' follow up but was not consistently better than audit alone in improving treatment or risk factor levels . Underst and ing the reasons for this is the key next step in improving the quality of care of patients with coronary heart disease . What is already known on this topic Effective preventive care of patients with any chronic disease requires planned and quality assured follow up on the basis of an up to date register Strategies for changing clinical practice in primary care have been of limited effectiveness What this study adds Setting up a coronary heart disease register for a practice substantially increases follow up and adequate assessment of patients at risk Improved assessment and follow up does not necessarily improve clinical outcome Follow up by nurses is as effective as , and may be more effective than , follow up by doctors Patients are being followed up and adequately assessed without the recommended preventive drugs being",
"Abstract Objective : To study the efficacy of case method learning , for general practitioners , on patients ' lipid concentrations in the secondary prevention of coronary artery disease . Design : Prospect i ve controlled trial . Setting : Södertälje , Stockholm County , Sweden . Participants : 255 consecutive patients with coronary artery disease . Intervention : Guidelines were mailed to all general practitioners ( n=54 ) and presented at a common lecture . General practitioners who were r and omised to the intervention group participated in recurrent case method learning dialogues at their primary healthcare centres during a two year period . A locally well known cardiologist served as a facilitator . Main outcome measure : Concentration of low density lipoprotein cholesterol at baseline and after two years . Analysis according to intention to treat ( intervention and control groups ( n=88 ) ) was based on group affiliation at baseline . Results : Low density lipoprotein cholesterol was reduced by 0.5 mmol/l ( 95 % confidence interval 0.2 to 0.8 mmol/l ) ( 9.3 % ( 2.9 % to 15.8 % ) ) from baseline in patients in the intervention group and by 0.5 ( 0.1 to 0.9 ) mmol/l compared with controls ( P to 0.2 ) mmol/l ) . Low density lipoprotein cholesterol decreased by 0.6 ( 0.4 to 0.8 ) mmol/l in a group of patients who received specialist care . Conclusion : Case method learning result ed in a lowering of low density lipoprotein cholesterol in the primary care patients with coronary artery disease comparable to that achieved at a specialist clinic . Conventional presentation of practice guidelines had no effect",
"OBJECTIVES This study involving 570 women aged 60 years or older with heart disease , assessed the effects of a disease management program on physical functioning , symptom experience , and psychosocial status . METHODS Women were r and omly assigned to control or program groups . Six to eight women met weekly with a health educator and peer leader over 4 weeks to learn self-regulation skills with physical activity as the focus . Evaluative data were collected through telephone interviews , physical assessment s , and medical records at baseline and 4 and 12 months post baseline . RESULTS At 12 months , compared with controls , program women were less symptomatic ( p dimension of the Sickness Impact Profile ( SIP ; p improved ambulation as measured by the 6-minute walk ( p lost more body weight ( p psychosocial factors as measured by the SIP were noted . CONCLUSION A self-regulation-based program that was provided to older women with heart disease and that focused on physical activity and disease management problems salient to them , improved their physical functioning and symptom experience . Psychosocial benefit was not evident and may be a result of measurement error or due to insufficient program time spent on psychosocial aspects of functioning",
"Abstract Objective : To assess the value of health education for patients with angina in reducing risk factors for cardiovascular disease and lessening the effect of angina on everyday activities . Design : R and omised controlled trial of personal health education given every four months . Setting : 18 general practice s in the greater Belfast area . Subjects : 688 patients aged less than 75 years and known to have had angina for at least six months ; 342 r and omised to receive education and 346 to no education . Main outcome measures : Restriction of everyday activities , dietary habit , smoking habit , frequency of physical exercise ; blood pressure , body mass index , and serum total cholesterol concentration at entry to trial and after two years . Results : 317 in the intervention group and 300 in the control group completed the trial . At the two year review more of the intervention group ( 140 , 44 % ) reported taking daily physical exercise than the control group ( 70 , 24 % ) . The intervention group also reported eating a healthier diet than the control group and less restriction by angina in any everyday activity . No significant differences were found between the groups in smoking habit , systolic or diastolic blood pressure , cholesterol concentration , or body mass index . Conclusion : Despite having no significant effect on objective cardiovascular risk factors , personal health education of patients with angina seems to increase exercise and improve dietary habits and is effective in lessening the restriction of everyday activities",
"BACKGROUND Case-management programs for secondary prevention of coronary artery disease that utilize extensive re sources can reduce cardiovascular risk factors , but less intensive approaches have failed to show benefits . This r and omized trial evaluated whether a medium intensity case-management program improves risk factor control in patients with coronary artery disease . METHODS We assigned 201 consecutive patients hospitalized for acute coronary events in the intensive care unit of University Hospital , Basel , Switzerl and , to either a risk factor case-management program ( n = 99 ) or care as usual ( n = 102 ) using the patients ' primary care physicians as the unit of r and omization ( cluster r and omization ) . The case-management program consisted of an hour of counseling by a clinician during hospitalization and two short reminders by phone and mail 3 and 6 months later . Treatment decisions were left to patients and their primary care physicians . RESULTS After 9 and 18 months of follow-up , there were no significant differences in lipid values , blood pressure control , fasting blood glucose , body-mass index , or number of smokers between the two groups . However , significantly more patients in the intervention group than in the care as usual group achieved target cholesterol values after 18 months ( 48 % versus 27 % , P = 0.002 and remained significant after Bonferroni-Holms correction ) but not after 9 months of follow-up ( 31 % versus 27 % , P > 0.2 ) . CONCLUSION This hospital-based case-management and outreach program , limited to counseling by a clinician , did not substantially improve cardiovascular risk factor control among patients hospitalized for coronary events",
"OBJECTIVE : Suboptimal treatment of hyperlipidemia in patients with coronary artery disease ( CAD ) is well documented . We report the impact of a computer-assisted physician-directed intervention to improve secondary prevention of hyperlipidemia . DESIGN AND SETTING : Two hundred thirty-five patients under the care of 14 primary care physicians in an academically affiliated practice with an electronic health record were enrolled in this proof-of-concept physician-blinded r and omized , controlled trial . Each patient with CAD or risk equivalent above National Cholesterol Education Program-recommended low-density lipoprotein ( LDL ) treatment goal for greater than 6 months was r and omized , stratified by physician and baseline LDL . Physicians received a single e-mail per intervention patient . E-mails were visit independent , provided decision support , and facilitated “ one-click ” order writing . MEASUREMENTS : The primary outcomes were changes in hyperlipidemia prescriptions , time to prescription change , and changes in LDL levels . The time spent using the system was assessed among intervention patients . RESULTS : A greater proportion of intervention patients had prescription changes at 1 month ( 15.3 % vs 2 % , P=.001 ) and 1 year ( 24.6 % vs 17.1 % , P=.14 ) . The median interval to first medication adjustment occurred earlier among intervention patients ( 0 vs 7.1 months , P=.005 ) . Among patients with baseline LDLs > 130 mg/dL , the first postintervention LDLs were substantially lower in the intervention group ( 119.0 vs 138.0 mg/dL , P=.04 ) . Physician processing time was under 60 seconds per e-mail . CONCLUSION : A visit-independent disease management tool result ed in significant improvement in secondary prevention of hyperlipidemia at 1-month postintervention and showed a trend toward improvement at 1 year",
"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",
"Objective To test the effectiveness of a complex intervention design ed , within a theoretical framework , to improve outcomes for patients with coronary heart disease . Design Cluster r and omised controlled multicentre trial . Setting General practice s in Northern Irel and and the Republic of Irel and , regions with different healthcare systems . Participants 903 patients with established coronary heart disease registered with one of 48 practice s. Intervention Tailored care plans for practice s ( practice based training in prescribing and behaviour change , administrative support , quarterly newsletter ) , and tailored care plans for patients ( motivational interviewing , goal identification , and target setting for lifestyle change ) with review s every four months at the practice s. Control practice s provided usual care . Main outcome measures The proportion of patients at 18 month follow-up above target levels for blood pressure and total cholesterol concentration , and those admitted to hospital , and changes in physical and mental health status ( SF-12 ) . Results At baseline the numbers ( proportions ) of patients above the recommended limits were : systolic blood pressure greater than 140 mm Hg ( 305/899 ; 33.9 % , 95 % confidence interval 30.8 % to 33.9 % ) , diastolic blood pressure greater than 90 mm Hg ( 111/901 ; 12.3 % , 10.2 % to 14.5 % ) , and total cholesterol concentration greater than 5 mmol/l ( 188/860 ; 20.8 % , 19.1 % to 24.6 % ) . At the 18 month follow-up there were no significant differences between intervention and control groups in the numbers ( proportions ) of patients above the recommended limits : systolic blood pressure , intervention 98/360 ( 27.2 % ) v control , 133/405 ( 32.8 % ) , odds ratio 1.51 ( 95 % confidence interval 0.99 to 2.30 ; P=0.06 ) ; diastolic blood pressure , intervention 32/360 ( 8.9 % ) v control , 40/405 ( 9.9 % ) , 1.40 ( 0.75 to 2.64 ; P=0.29 ) ; and total cholesterol concentration , intervention 52/342 ( 15.2 % ) v control , 64/391 ( 16.4 % ) , 1.13 ( 0.63 to 2.03 ; P=0.65 ) . The number of patients admitted to hospital over the 18 month study period significantly decreased in the intervention group compared with the control group : 107/415 ( 25.8 % ) v 148/435 ( 34.0 % ) , 1.56 ( 1.53 to 2.60 ; P=0.03 ) . Conclusions Admissions to hospital were significantly reduced after an intensive 18 month intervention to improve outcomes for patients with coronary heart disease , but no other clinical benefits were shown , possibly because of a ceiling effect related to improved management of the disease . Trial registration Current Controlled Trials IS RCT N24081411",
"Objective To evaluate the effectiveness of a structured group education programme on biomedical , psychosocial , and lifestyle measures in people with newly diagnosed type 2 diabetes . Design Multicentre cluster r and omised controlled trial in primary care with r and omisation at practice level . Setting 207 general practice s in 13 primary care sites in the United Kingdom . Participants 824 adults ( 55 % men , mean age 59.5 years ) . Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care . Main outcome measures Haemoglobin A1c levels , blood pressure , weight , blood lipid levels , smoking status , physical activity , quality of life , beliefs about illness , depression , and emotional impact of diabetes at baseline and up to 12 months . Main results Haemoglobin A1c levels at 12 months had decreased by 1.49 % in the intervention group compared with 1.21 % in the control group . After adjusting for baseline and cluster , the difference was not significant : 0.05 % ( 95 % confidence interval −0.10 % to 0.20 % ) . The intervention group showed a greater weight loss : −2.98 kg ( 95 % confidence interval −3.54 to −2.41 ) compared with 1.86 kg ( −2.44 to −1.28 ) , P=0.027 at 12 months . The odds of not smoking were 3.56 ( 95 % confidence interval 1.11 to 11.45 ) , P=0.033 higher in the intervention group at 12 months . The intervention group showed significantly greater changes in illness belief scores ( P=0.001 ) ; directions of change were positive indicating greater underst and ing of diabetes . The intervention group had a lower depression score at 12 months : mean difference was −0.50 ( 95 % confidence interval −0.96 to −0.04 ) ; P=0.032 . A positive association was found between change in perceived personal responsibility and weight loss at 12 months ( β=0.12 ; P=0.008 ) . Conclusion A structured group education programme for patients with newly diagnosed type 2 diabetes result ed in greater improvements in weight loss and smoking cessation and positive improvements in beliefs about illness but no difference in haemoglobin A1c levels up to 12 months after diagnosis . Trial registration Current Controlled Trials IS RCT N17844016",
"Occupational reintegration after coronary heart disease of patients who are insured by the German workers pension ( Arbeiterrentenversicherung ) succeeds in 40 - 60 % of the recorded cases . Patients who were not able to return to work after finishing their regular cardiac rehabilitation took part in a program called \" Intensivierte Nachsorge ( INA ) \" . INA is an interdisciplinary support program , taking place twice a week for a whole day over a period of six weeks . On the remaining three days patients were either progressively reintegrated into their working place or stayed at home . The results of the INA group were compared to those of a control group . Two years after patients had terminated the cardiac rehabilitation , statistically significant effects could still be found : 70.2 % of the INA group had returned to work compared to 52.6 % of the control group . This is a difference of 17.6 % . After the results had been corrected by considering age differences between the two groups , the control group had a recalculated return to work rate of 57.4 % . A significant difference of 12.8 % could still be identified with respect to the INA group . Support programs which follow regular cardiac rehabilitation seem to be specially suitable for older patients with highly perceived job strain , because our results showed that these patients had lower return to work rates . 44.2 % of the INA group and 21.9 % of the control group were progressively reintegrated into their work place . Two years after their regular rehabilitation 36.3 % of the INA group patients took part in ambulatory heart groups compared with 10.4 % of the control group . It was also found that patients of the INA group showed improvements in activities of daily life . The INA program however does not seem to have an influence on behavioral components such as eating habits , relaxation , and smoking as well as on the psychological status . The physical fitness measured in watt x min at the beginning of the INA program ( T1 ) was 589.46 + /- 255.03 in the control group . This number increased to 598.32 + /- 276.01 six months after regular rehabilitation ( T3 ) and continued to rise to 661.15 + /- 362.01 after two years ( T4 ) . In the INA group the numbers were as follows : 658.13 + /- 263.63 at T1 , 751.83 + /- 318.15 at T3 , and 717.93 + /- 336.76 at T4 . The differences between the groups are significant at T1 and T3 , whereas at T4 there is no significant difference . It should also be stated that the lipid parameters indicated no differences between the groups except for the triglyceride values which were significantly lower statistically in the INA group than in the control group",
"OBJECTIVE : To examine the ability of a secondary prevention programme to improve the lifestyle in myocardial infa rct ion patients aged 50 - 70 years . DESIGN : Habitual physical activity , food habits , and smoking habits were assessed from question naires at admission to hospital and at the one year follow up . Initially , all patients were invited to join an exercise programme and were informed about cardiovascular risk factors . Four weeks after discharge from the hospital , 87 patients were r and omised to follow up at the coronary prevention unit by a special trained nurse ( the intervention group ) , and 81 to follow up by their general practitioners ( the usual care group ) . After r and omisation , the intervention group was educated about the effects of smoking cessation , dietary management , and regular physical activity . The intervention group also participated in a physical training programme two to three times weekly for 10 - 12 weeks . MAIN RESULTS : 89 % of the patients referred to the intervention group improved their food habits compared with 62 % of the patients referred to the usual care group ( P = 0.008 ) . Furthermore , 50 % of the smokers referred to the intervention group stopped smoking compared to 29 % in the usual care group ( P = 0.09 ) . Changes in physical activity did not differ between the groups . CONCLUSIONS : This secondary prevention programme based on a nurse rehabilitator was successful in improving food habits in patients with acute myocardial infa rct ion . Initiating the smoking cessation programme during the hospital stay followed by repeated counselling during follow up might have improved the results . The exercise programme had no advantage in supporting physical activity compared to usual care",
"BACKGROUND Although primary care is the major target of coronary heart disease ( CHD ) clinical recommendations , little is known of how community physicians view guidelines and their implementation . The REACT survey was design ed to assess the views , and perceived implementation , of CHD and lipid treatment guidelines among primary care physicians . METHODS Semi-structured vali date d telephone interviews were conducted , in the relevant native tongue , with 754 r and omly selected primary care physicians ( GPs and family doctors ) in five European countries ( France , Germany , Italy , Sweden and the UK ) . RESULTS Most physicians ( 89 % ) agreed with the content of current guidelines and reported use of them ( 81 % ) . However , only 18 % of physicians believed that guidelines were being implemented to a major extent . Key barriers to greater implementation of guidelines were seen as lack of time ( 38 % of all physicians ) , prescription costs ( 30 % ) , and patient compliance ( 17 % ) . Suggestions for ways to improve implementation centred on more education , both for physicians themselves ( 29 % ) and patients ( 25 % ) ; promoting , publicizing or increasing guideline availability ( 23 % ) ; simplifying the guidelines ( 17 % ) ; and making them clearer ( 12 % ) . Physicians perceived diabetes to be the most important risk factor for CHD , followed by hypertension and raised LDL-C. Most physicians ( 92 % ) believe their patients do associate high cholesterol levels with CHD . After establishing that a patient is ' at risk ' of CHD , physicians reported spending an average of 16.5 minutes discussing risk factors and lifestyle changes or treatment that is required . Factors preventing this included insufficient time ( 42 % ) , having too many other patients to see ( 27 % ) and feeling that patients did not listen or underst and anyway ( 21 % ) . CONCLUSIONS Primary care physicians need more information and support on the implementation of CHD and cholesterol guideline recommendations . This need is recognized by clinicians",
"OBJECTIVES Psychosocial factors , such as stress and vital exhaustion , are associated with an increased risk of cardiovascular events , and women report more psychosocial ill-being after an acute myocardial infa rct ion than men . We have earlier shown that a cognitive-behavioural intervention in women with ischaemic heart disease ( IHD ) improved psychosocial well-being . In the present study , we tested the hypothesis that the improvement in psychosocial well-being is associated with an improvement in biochemical indicators of cardiovascular risk . DESIGN R and omized-controlled trial in northern Sweden . SETTING Outpatient care . SUBJECTS Women with IHD were r and omized to either a 1-year cognitive-behavioural stress management programme or usual care . Of the 159 women who completed the study , 77 were in the intervention group , and 82 in the control group . INTERVENTIONS A 1-year cognitive-behavioural stress management programme versus conventional care . RESULTS Group assignment was not found to be a determinant of waist circumference , high sensitive C-reactive protein ( hs-CRP ) , fibrinogen , von Willebr and factor ( vWF ) , plasminogen activator inhibitor type 1 ( PAI-1 ) activity , tissue plasminogen activator ( tPA ) activity , tPA antigen , tPA-PAI-1 complex , leptin , or HOMA2 insulin resistance index ( HOMA2-IR ) at follow up . Changes in psychosocial variables were not associated with changes in any of the biological risk indicators . CONCLUSIONS Even if our cognitive-behavioural stress management programme had effects on proximal targets , such as stress behaviour and vital exhaustion , we found no improvement in intermediate biochemical targets related to the metabolic syndrome and IHD . Our results challenge the proposition that the relationship between psychological well-being and biological cardiovascular risk indicators is a direct cause-effect phenomenon",
"BACKGROUND Secondary prevention medications in cardiac patients improve outcomes . However , prescription rates for these drugs and long-term adherence are suboptimal . OBJECTIVE To determine whether an enhanced secondary prevention program improves outcomes . METHODS Hospitalized patients with indications for secondary prevention medications were r and omly assigned to either usual care or an intervention arm , in which an intensive program was used to optimize prescription rates and long-term adherence . Follow-up was 19 months . RESULTS A total of 2643 patients were r and omly assigned in the study ; 1342 patients were assigned to usual care and 1301 patients were assigned to the intervention arm . Prescription rates were near optimal except for lipid-lowering medications . Rehospitalization rates per 100 patients were 136.2 and 132.6 over 19 months in the usual care and intervention groups , respectively ( P=0.59 ) . Total days in hospital per patient were similar ( 10.9 days in the usual care group versus 10.2 days in the intervention group ; P not significant ) . Crude mortality was 6.2 % and 5.5 % in the usual care and intervention groups , respectively , with no significant difference ( P=0.15 ) in overall survival . Post hoc analysis suggested that after the study team became experienced , days in hospital per patient were reduced by the program ( 11.1+/-0.91 and 8.9+/-0.61 in the usual care and intervention groups , respectively ; P intervention program failed to improve outcomes in the present study . One explanation for these results is the near optimal physician compliance with guidelines in both groups . It is also possible that a substantial learning curve for the staff was involved , as suggested by the reduction in total days in hospital in the intervention patients during the second part of the study",
"AIM The aim of this study was to examine the effect of a cardiac rehabilitation programme on health behaviours and physiological risk parameters in patients with coronary heart disease in Chengdu , China . BACKGROUND Epidemiological studies indicate a dose- , level- and duration -dependent relationship exists between cardiac behavioural and physiological risks and coronary heart disease incidence as well as subsequent cardiac morbidity and mortality . Cardiac risk factor modification has become the very primary goal of modern cardiac rehabilitation programmes . DESIGN METHODS A r and omized controlled trial was conducted . Coronary heart disease patients ( n = 167 ) who met the sampling criteria in two tertiary medical centres in Chengdu , south-west China , were r and omly assigned to either an intervention group ( the cardiac rehabilitation programme ) or control group ( the routine care ) . The change of health behaviours ( walking performance , step II diet adherence , medication adherence , smoking cessation ) and physiological risk parameters ( serum lipids , blood pressure , body weight ) were assessed to evaluate the programme effect . RESULTS Patients in the intervention group demonstrated a significantly better performance in walking , step II diet adherence , medication adherence ; a significantly greater reduction in serum lipids including triglyceride , total cholesterol , low-density lipoprotein ; and significantly better control of systolic and diastolic blood pressure at three months . The majority of these positive impacts were maintained at six months . The effect of the programme on smoking cessation , body weight , serum high-density lipoprotein , was not confirmed . CONCLUSIONS A cardiac rehabilitation programme led by a nurse can significantly improve the health behaviours and cardiac physiological risk parameters in coronary heart disease patients . Nurses can fill significant treatment gaps in the risk factor management of patients with coronary heart disease . RELEVANCE TO CLINICAL PRACTICE This study raises attention regarding the important roles nurses can play in cardiac rehabilitation and the unique way for nurses to meet the rehabilitative care needs of coronary heart disease patients . Furthermore , the hospital-home bridging nature of the programme also created a model for interfacing the acute care and community rehabilitative care",
"OBJECTIVE : To measure the potential for secondary prevention of coronary disease in the United Kingdom . DESIGN : Cross sectional survey of a representative sample of coronary patients from a retrospective review of hospital medical records and patient interview and examination . SETTING : Stratified r and om sample of 12 specialist cardiac centres and 12 district general hospitals drawn from 34 specialist cardiac centres and 261 district general hospitals in 12 geographic areas in the United Kingdom . SUBJECTS : 2583 patients MAIN OUTCOME MEASURES : Risk factor recording and management in medical records ; the prevalence and control of risk factors at interview six months after the procedure or event . RESULTS : Recording of coronary risk factors in patient 's records was incomplete and this varied by risk factor . Smoking habit and blood pressure were most completely recorded , whereas a history of hyperlipidaemia and blood cholesterol concentrations were least complete . Risk factor records were more likely to be complete in cardiac centres than in district hospitals . At interview 10 % to 27 % of patients were still smoking cigarettes and 75 % remained overweight , females more severely so . Up to a quarter of patients remained hypertensive , males more severely so than females . Over three quarters had a total cholesterol > 5.2 mmol/l . In patients on medication for blood pressure , cholesterol or glucose , risk factor profiles were little better than in those who were not . Only about one patient in three was taking a beta blocker after infa rct ion . Up to a fifth of patients who had had acute myocardial ischaemia were not taking aspirin at follow up . CONCLUSIONS : There is considerable potential to reduce the risk of a further major ischaemic event in patients with established coronary disease . This can be achieved by effective lifestyle intervention , the rigorous management of blood pressure and cholesterol , and the appropriate use of prophylactic drugs",
"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",
"Table . SI Units Systematic modification of coronary risk factors is not integrated into the medical care provided to most of the more than 1 million patients treated annually in the United States for acute myocardial infa rct ion by percutaneous transluminal coronary angioplasty or coronary artery surgery . Most of such patients have lipoprotein abnormalities [ 1 ] , and nearly one half smoke [ 2 ] . These risk factors , which contribute to subsequent morbidity and mortality , remain highly prevalent after acute cardiac events . Failure to integrate comprehensive risk factor modification into the st and ard medical care provided to patients after acute cardiac events primarily reflects the lack of an organizational framework or system . This deficiency in re source allocation for preventive and rehabilitative aspects of care in turn reflects the predominant orientation of the U.S. health care system to the management of acute illness [ 3 ] . Several clinical research studies have shown the effectiveness of risk factor modification , especially treatment of lipoprotein abnormalities [ 4 - 7 ] , in achieving regression of coronary artery lesions and reducing the clinical consequences of coronary artery disease [ 6 , 7 ] . However , risk factor interventions shown to be effective in clinical trials may not prove equally effective in clinical practice because of a paucity of re sources , especially nonphysician personnel . The lack of effective management systems limits the expected reduction in morbidity and mortality and the corresponding reduction in medical care costs that motivates current efforts to orient the priorities of the American health care system toward preventive and rehabilitative care . This r and omized , controlled trial compared the effectiveness of a physician-directed , nurse-managed , home-based case-management system for coronary risk factor modification with that of usual medical care . Outcomes were measured in both groups immediately after the end of the first year after acute myocardial infa rct ion . The term case-management system has been used in various context s. As used here , it refers to a system in which a nurse case-manager , working with different health care specialists ( a psychiatrist , a cardiologist , a lipid specialist , a nutritionist , and a nurse coordinator ) , managed coronary risk factors . Methods Enrollment and Orientation Program nurses enlisted patients on hospital day 3 or as soon as their medical condition stabilized . Study participants gave written informed consent to be r and omly assigned to a treatment group . Immediately after r and omization , program nurses introduced patients to the special intervention with the aid of a videotape . Usual Care The 585 patients in our study were cared for by 215 internists and 34 cardiologists in the five participating medical centers who were organized into practice groups of 5 to 10 physicians each . Cardiology consultation was often provided during hospitalization , but primary responsibility for follow-up care was generally assumed by internists . The usual care offered by the Kaiser Permanente Medical Care Program included physician counseling on smoking cessation and nutritionist counseling on dietary change during hospitalization and physician-managed , lipid-lowering drug therapy after hospital discharge . Group outpatient smoking cessation programs were available for a $ 50 fee . Group exercise rehabilitation , not generally provided by the Kaiser Permanente Medical Care Program during this study , was available to patients at various community facilities at an average cost of $ 1800 to $ 2700 for 3 months ' participation . Special Intervention The behavioral interventions in our case-management system , which were offered to the 293 patients in the intervention group in addition to usual care , were derived from social learning theory [ 8 , 9 ] and modified for medical problems [ 10 ] . In this model , persons must learn how to monitor the health habits they seek to change , set attainable sub goals to motivate and direct their efforts , use feedback of progress in ways that promote health , and enlist incentives and social support to sustain the effort needed to succeed [ 8 , 9 ] . In the hospital , patients were instructed on how to complete self-reports [ status reports ] of smoking , dietary intake , and exercise . Scheduled interactions between case managers and patients after discharge took three forms : 1 ) nurse-initiated telephone contacts ; 2 ) computer-generated progress reports mailed to patients based on question naires completed by patients and mailed to the nurses ; and 3 ) visits to the program nurse for treadmill exercise testing , initiation of lipid-lowering drug therapy , if indicated , and a single counseling session after a smoking relapse . The maximum number of treatment contacts during the year , including outcome measurement at 6 and 12 months , was as follows : 14 nurse-initiated telephone contacts , 8 patient visits to the blood chemistry laboratory , and 4 patient visits to the nurse case manager . Smoking Intervention Smoking was defined as the use of cigarettes , cigars , cigarillos , pipe tobacco , or any other form of tobacco in the 6 months before admission . Forty-three percent of patients were smokers . Patients who had smoked during the 6 months before hospitalization received the same intensive smoking cessation intervention during hospitalization ; this intervention has been described previously [ 11 ] . Physicians used a written script that enabled them to provide st and ardized counseling in less than 2 minutes . The hospital-based smoking cessation counseling focused on relapse prevention . Nurses conducted a st and ardized smoking history to evaluate patients ' addiction to smoking . Patients ' reported self-efficacy or confidence to resist smoking in each of 28 potentially high-risk situations was measured ; patients were then counseled on how to manage the situations in which they reported less than 70 % confidence . Patients also received a relapse prevention manual and a relaxation audiotape . They were advised that the nurse would telephone them 48 hours and 1 week after hospital discharge and at monthly intervals for as long as 6 months . Patients who relapsed were offered one additional visit with the nurse for further counseling . Nicotine polacrilex or transdermal nicotine patches were reserved for highly addicted patients who relapsed after hospital discharge . Nutritional Counseling A computer-based expert system developed by the investigators was used to provide nutritional counseling on a National Cholesterol Education Program [ 12 ] Step 2 diet that was low in cholesterol and saturated fat . A food frequency question naire design ed by the investigators was scored using the Cholesterol and Saturated Fat Index developed by Connor and colleagues [ 13 ] . Calculations of cholesterol and saturated fat totals were based on weekly rather than daily average food intakes . Data from the food frequency question naires , mailed by patients to the Stanford coordinating center and entered into a microcomputer , were used to generate progress reports that characterized patients ' dietary patterns , prioritized dietary change goals , and provided guides for managing difficult situations by directing patients to relevant sections of a nutrition workbook entitled Good Eating for Good Health developed by the program nutritionist . Patients in the intervention group completed a food frequency question naire during hospitalization that described their eating habits in the previous month . Patients also completed food frequency question naires 6 , 11 , and 26 weeks after admission . Progress reports were mailed to patients within 48 to 72 hours after the food frequency question naires were received . Detailed strategies for maintenance of dietary change were incorporated into the 26-week progress report . Question naires to evaluate outcomes were also completed at 36 and 52 weeks . Lipid-Lowering Drug Therapy The therapeutic goal of a plasma low-density lipoprotein (LDL)-cholesterol value of 2.46 mmol/L ( 95 mg/dL ) adopted for this trial was based on the mean post-treatment level of LDL cholesterol found in patients in the study by Blankenhorn and colleagues [ 4 ] . Patients with mean plasma LDL cholesterol values ( based on measurements in two separate blood sample s drawn 75 and 90 days after infa rct ion ) that exceeded this value were given initial drug therapy according to the four algorithms shown in Table 1 . Patients unable to tolerate bile acid-binding resin or nicotinic acid because of comorbid conditions or potentially adverse interactions with these agents received lovastatin or gemfibrozil . During a visit 90 days after discharge , the nurses did a brief physical examination and obtained a history relevant to hyperlipidemia . They provided detailed counseling to patients regarding the rationale for lipid-lowering drug therapy and ways to maximize drug efficacy and minimize drug side effects , and they advised patients on the schedule of laboratory visits and nurse-initiated follow-up telephone contacts . Table 1 . Initial Drug Therapy * Changes in drug therapy at 120 , 150 , and 180 days , which were coordinated by nurse-initiated telephone contacts , were based on three types of responses to initial therapy : 1 ) if lipoprotein levels returned to normal , the effective drug therapy was continued ; 2 ) if the response was incomplete , the dose of the effective medication was increased or another drug was added , or both ; and 3 ) if comorbid conditions worsened or blood chemistry abnormalities or intolerable side effects occurred , drug dosage was reduced or the patient was switched to another agent or both . A physician lipid specialist and a Stanford-based senior nurse-coordinator provided telephone consultation to the case managers . Before initiating lipid-lowering drug therapy at 90 days and at each subsequent step , nurses review ed the patients ' blood chemistry and lipoprotein values and elicited any symptoms requiring a change in therapy . The",
"BACKGROUND Most studies that have analysed the effect of secondary prevention of coronary heart disease come from hospitals . Those that are community-based have been conducted mainly by nurses and follow-up was generally too short to show impact on cardiovascular events . METHODS This is a multi-centre r and omised controlled clinical trial in which patients in the intervention group received periodic postal reminders to see their general practitioner every three months during a 3-year follow-up . General practitioners reinforced healthy lifestyle recommendations to patients and review ed drug therapies at these quarterly intervals . Patients in the control group received usual care . RESULTS A total of 983 patients aged 30 - 79 were included . During the 3-year follow-up , 67 patients died and 156 experienced a non-fatal cardiovascular event . The event rates and all-cause mortality were similar in the intervention and control groups ( 24.0 % and 23.5 % , and 8.1 % and 9.9 % , respectively ) . Improvement in quality of life was similar in both groups . Blood pressure and high-density lipoprotein cholesterol were more frequently within recommended levels in the intervention group than in controls : odds ratio 1.63 , 95 % confidence interval 1.05 - 2.51 , and odds ratio 2.61 , 95 % confidence interval 1.32 - 5.18 , respectively . CONCLUSIONS Intensive secondary prevention conducted by general practitioners may improve long-term blood pressure control and increase high-density lipoprotein cholesterol in patients with stable coronary disease",
"BACKGROUND . Comprehensive preventive education for heart patients is effective in reducing cardiac events . However , very dem and ing counselling protocol s can not easily be implemented as an integral part of clinical practice in hospitals . AIM . To evaluate whether recurrent preventive group education for coronary artery bypass grafting patients affects the resistance of LDL against oxidation and the classical risk factors for coronary heart disease . METHODS . A prospect i ve , controlled study with one-year follow-up was carried out in Southern Finl and . Coronary artery bypass patients were allocated late ( S 18 months ) after the operation in the intervention and control groups . RESULTS . Seventy two patients ( 65 men and 7 women ) completed the study . Twelve-hour group education on healthy life-style had a significant ( 25 % , P = 0.01 ) but transient positive effect on the resistance of LDL against oxidation . There was a trend towards increased physical activity in the intervention group . The impact of education on patients ' weight was also more consistent ( 1.2 kg at 12 months , P fibrinogen and serum lipids were small . CONCLUSIONS . Repeated group education applied as an economically feasible part of specialist care had only small positive effects on patients ' risk factors . There was a significant , but transient , increase in the resistance of LDL against oxidation . However , effective lipid lowering drug treatment is indicated for most coronary artery bypass patients rather than repeated health education alone",
"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 whether postal prompts to patients who have survived an acute coronary event and to their general practitioners improve secondary prevention of coronary heart disease . Design : R and omised controlled trial . Setting : 52 general practice s in east London , 44 of which had received facilitation of local guidelines for coronary heart disease . Participants : 328 patients admitted to hospital for myocardial infa rct ion or unstable angina . Interventions : Postal prompts sent 2 weeks and 3 months after discharge from hospital . The prompts contained recommendations for lowering the risk of another coronary event , including changes to lifestyle , drug treatment , and making an appointment to discuss these issues with the general practitioner or practice nurse . Main outcome measures : Proportion of patients in whom serum cholesterol concentrations were measured;proportion of patients prescribed β blockers ( 6 months after discharge ) ; and proportion of patients prescribed cholesterol lowering drugs ( 1 year after discharge ) . Results : Prescribing of β bockers ( odds ratio 1.7,95 % confidence interval 0.8 to 3.0 , P>0.05 ) and cholesterol lowering drugs ( 1.7 , 0.8 to 3.4 , P>0.05 ) did not differ between intervention and control groups . A higher proportion of patients in the intervention group ( 64 % ) than in the control group ( 38 % ) had their serum cholesterol concentrations measured ( 2.9 , 1.5 to 5.5 , P . Secondary outcomes were significantly improved for consultations for coronary heart disease , the recording of risk factors , and advice given . There were no significant differences in patients ' self reported changes to lifestyle or to the belief that it is possible to modify the risk of another coronary event . Conclusions : Postal prompts to patients who had had acute coronary events and to their general practitioners in a locality where guidelines for coronary heart disease had been disseminated did not improve prescribing of effective drugs for secondary prevention or self reported changes to lifestyle . The prompts did increase consultation rates related to coronary heart disease and the recording of risk factors in the practice s. Effective secondary prevention of coronary heart disease requires more than postal prompts and the dissemination of guidelines",
"Health promotion programmes for patients with coronary heart disease are valuable,1 2 but there is little evidence on their lasting effect.3 A r and omised controlled trial in which patients who received personalised health promotion for two years showed significant benefits in lifestyle and quality of life.2 4 We investigated whether the differences in lifestyle , quality of life , and risk factors persisted between the two groups five years after enrolment . Patients aged under 75 who had had angina ( all grade s included ) for at least six months and no other concurrent serious illness were identified by 18 general practice s in Belfast . Their diagnosis was confirmed at interview , and they were r and omly allocated to receive either usual NHS care and personal health promotion from a trained nurse every four months for two years or usual NHS care alone . Sealed envelopes opened at interview showed group allocations . Both groups were review ed",
"PURPOSE Despite demonstrated benefits of cardiac rehabilitation and risk factor reduction , only 11 % to 38 % of eligible patients with cardiovascular disease ( CVD ) participate in cardiac rehabilitation programs . Women and older adults are particularly less likely to participate in cardiac rehabilitation . In an effort to broaden access to cardiac rehabilitation , the authors developed an alternative Internet-based program that allows nurse case managers to provide risk factor management training , risk factor education , and monitoring services to patients with CVD . METHODS The evaluation consisted of a r and omized , clinical trial involving 104 patients with CVD , 53 of whom used the program as a special intervention ( SI ) for 6 months and 51 of whom received usual care ( UC ) . RESULTS The results indicate that fewer cardiovascular events occurred among the SI subjects ( 15.7 % ) than among the UC subjects ( 4.1 % ) ( P = .053 ) , result ing in a gross cost savings of $ 1418 US dollars per patient . With a projected program cost of $ 453 USD per patient , the return on investment is estimated at 213 % . More weight loss occurred in the SI group ( -3.68 pounds ) than in the UC group ( + .47 pounds ) ( P = .003 ) . The differences between the two groups in terms of blood pressure , lipid levels , depression scores , minutes of exercise , and dietary habits were not statistically significant . CONCLUSION An Internet-based case management system could be used as a cost-effective intervention for patients with CVD , either independently or in conjunction with traditional cardiac rehabilitation",
"Background : After the cardiovascular events of myocardial infa rct ion ( MI ) and coronary artery bypass surgery ( CABS ) , unpartnered older adults are a vulnerable group that may benefit from interventions to improve health outcomes . The purpose of this analysis is to determine if a community-based collaborative peer advisor/advanced practice nurse intervention increased participation in cardiac rehabilitation programs and reduced hospital readmissions after MI and CABS and determine whether the type of cardiovascular event influenced rehospitalization . Subjects and Methods : This study was a r and omized clinical trial that enrolled 247 unpartnered older adults who were single , widowed , or divorced . Subjects were r and omized into 4 groups : st and ard of care group for MI and for CABS and st and ard of care plus the treatment groups for MI and for CABS , for 12 weeks after discharge . There were 163 women/84 men , with a mean age of 76.4 years , who were admitted for MI ( n = 93 ) or CABS ( n = 154 ) and who were enrolled from 5 academic medical centers . The treatment consisted of a community-based intervention of a home visit within 72 hours and telephone calls at 2 , 6 , and 10 weeks from an advanced practice nurse and 12 weekly telephone calls from a peer advisor . Participation in a cardiac rehabilitation program and rehospitalizations were collected at 6 weeks and 3 , 6 , and 12 months by telephone interview . Results and Conclusions : There were significantly more participants in cardiac rehabilitation programs after 3 months in the treatment group , and this increase was seen up to 1 year after MI and CABS . There were no statistical differences , although there were fewer rehospitalizations between 3 and 6 months after MI and CABS in the treatment group compared with the st and ard of care group . Overall , the evidence from this study suggests that a community-based collaborative peer advisor/advanced practice nurse intervention can play a role in promoting active participation in cardiac rehabilitation programs and fewer rehospitalizations in unpartnered older adults after MI and CAGS",
"BACKGROUND Local opinion leaders are educationally and socially influential physicians . Although they can accelerate the adoption of new evidence in hospitals , their impact on the quality of prescribing for out patients has only been examined by a few studies . We hypothesized that an intervention consisting of patient-specific one-page evidence summaries , generated and endorsed by local opinion leaders , would improve prescribing of angiotensin-converting enzyme ( ACE ) inhibitors or angiotensin receptor blockers ( ARBs ) in heart failure ( HF ) and that of statins in ischemic heart disease ( IHD ) . METHODS We conducted a community-based r and omized controlled trial in patients with HF ( not receiving ACE inhibitors or ARBs ) and those with IHD ( not receiving statins ) who were recruited from 40 pharmacies and allocated either to the opinion leader intervention or to usual care based on r and omization of their primary care physician . The primary outcome was an increase in the use of efficacious therapies ( ACE inhibitors or ARBs in HF and statins in IHD ) within 6 months ; the secondary outcomes were prescribing changes for HF or IHD . RESULTS A total of 171 patients participated in the study ; 87 were allocated to the intervention , whereas 84 were assigned to the control group . The median age of the participants was 75 years ; 103 ( 60 % ) were female , 54 ( 32 % ) had HF , and 117 ( 68 % ) had IHD . Overall , 21 ( 24 % ) intervention patients started receiving an efficacious medication within 6 months , as compared with 15 ( 18 % ) control subjects ( relative risk of improvement 1.32 , 95 % CI 0.73 - 2.40 , P = .31 ) . In the HF subgroup , 38 % of the intervention patients started receiving an ACE inhibitor or ARB therapy , as compared with 20 % of control subjects ( relative risk of improvement 1.90 , 95 % CI 0.76 - 4.72 , P = .15 ) . In the IHD subgroup , 17 % of the intervention patients and 17 % of the control subjects started receiving statin therapy ( P = .97 ) . CONCLUSIONS The influence of local opinion leaders may be useful for improving the quality of cardiovascular prescribing in the community , but the benefits are likely modest and may be disease specific . Further studies on this method are warranted",
"The effects of a nurse-managed secondary prevention program for patients after acute cardiac events were examined . Special interest was given to gender-specific results . The design was a prospect i ve , r and omized , controlled trial involving 343 patients following 3 weeks of inpatient cardiac rehabilitation , r and omly assigned to either of two study groups . Patients in the treatment group were contacted monthly by phone over 1 year . The main goals of the intervention were the reduction of behavioural coronary risk factors and enhancing quality of life . The program was conducted by specially trained nurses . The control group received written information only . Primary outcome was the Framingham risk score . Follow-up examination after 12 months was completed by 297 patients . Patients in the intervention group showed lower Framingham risk scores as compared to controls . Separate analyses by sex revealed that this was mostly due to the men in the sample . Women , on the other h and , showed a significant rise of clinical ly relevant anxiety/depressiveness in the control but not in the intervention group ; in males there were no differences between study conditions . In conclusion , telephone counselling by specially trained nurses seems a cost-effective way to achieve a lasting reduction in cardiac risk factors and to maintain the effects of cardiac rehabilitation . Effekte eines von Pflegepersonal durchgefuehrten Nachsorgeprogramms fuer Koronarpatienten wurden untersucht . Besondere Aufmerksamkeit galt moeglichen Gendereffekten . Es h and elt sich um eine prospektive , r and omisierte , kontrollierte Studie . 343 Patienten wurden nach stationaerer kardiologischer Rehabilitation auf eine von zwei Studiengruppen r and omisiert . Patienten in der Interventions gruppe wurden über ein Jahr ca . einmal i m Monat telephonisch kontaktiert . Hauptziele der Intervention waren die effektive und nachhaltige Reduktion verhaltensgebundener Risikofaktoren sowie die Verbesserung der Lebensqualitaet . Das Programm wurde von speziell dafuer fortgebildetem Pflegepersonal durchgefuehrt . Die Kontrollgruppe erhielt nur schriftliches Informations material . Primaerer Endpunkt war das globale koronare Risiko ( Framingham Score ) . Von 297 Patienten wurden komplette Date n bei der Abschlussuntersuchung nach 12 Monaten erhalten . Patienten in der Interventions gruppe zeigten niedrigere Framingham-Scores als Kontrollpatienten . Getrennte Analysen nach Geschlecht ergaben , dass dieser Effekt hauptsaechlich auf die Maenner zurueckzufuehren ist ; bei den Frauen zeigten sich keine Unterschiede zwischen den Studiengruppen . Auf der and eren Seite zeigte sich bei den Frauen in der Kontrollgruppe eine deutliche Zunahme an Angst bzw . Depressivitaet ; ein entsprechender Effekt f and sich bei den Maennern nicht . Telefonische Nachsorge durch speziell fortgebildetes Pflegepersonal scheint ein kostenguenstiger Weg zu sein , koronare Risikofaktoren zu reduzieren und die Effekte von kardiologischer Rehabilitation aufrechtzuerhalten . Se evaluaron los result ados de un programa secundario de prevención dirigido por el personal de enfermería para pacientes que han sufrido un trastorno cardiovascular agudo . Se dio una especial importancia a los result ados específicos para cada sexo . Se trata de un estudio prospect ivo , aleatorizado , comparativo , en el que participaron 343 pacientes tras 3 semanas de haber recibido rehabilitación cardiovascular , a quienes se dividieron en dos grupos , de manera aleatoria . Los pacientes del grupo que recibió tratamiento fueron contactados por teléfono una vez al mes durante 1 año . Los principales objetivos de la intervención fueron reducir los factores de riesgo de las cardiopatías arterioscleróticas relacionados con el actuar de los pacientes , y mejorar la calidad de vida de éstos . La realización del programa estuvo a cargo de un grupo de enfermeras y enfermeros especialmente entrenados para ello . El grupo de referencia recibió información sólo por escrito . Los result ados iniciales se obtuvieron aplic and o la escala de riesgo de Framingham . En las valoraciones de seguimiento , realizadas tras 12 meses , participaron 292 pacientes . Los valores en la escala de riesgo de Framingham fueron más bajos en los pacientes del grupo que recibió la intervención que en el grupo de referencia . Los análisis según el sexo revelaron que el aporte mayor a este result ado provino de los varones de la muestra . Por su parte , las mujeres del grupo de referencia presentaron un aumento importante de la ansiedad/depresión relacionada con el proceso de enfermedad , lo cual no se apreció en el grupo que recibió tratamiento . Entre los varones no se apreciaron diferencias relacionadas con las condiciones del estudio . En conclusión , el apoyo emocional por vía telefónica brindado por el personal de enfermería especialmente entrenado para ello parece ser una manera rentable de disminuir de forma perdurable los factores de riesgo para las cardiopatías arterioscleróticas , así como de perpetuar los result ados de la rehabilitación cardiovascular . Cette étude examine les effets d'un programme de prévention secondaire sous surveillance du personnel infirmier pour les patients ayant souffert d'incidents cardiaques aigus . Une attention toute particulière a été donnée aux résultats selon le sexe . L'essai était de type prospect if , r and omisé et contrôlé , avec la participation de 343 patients après 3 semaines de rééducation cardiaque dans des conditions d'hospitalisation , affectés de manière aléatoire à l'un ou l'autre des deux groupes d'étude . Les patients appartenant au groupe de traitement ont été contactés tous les mois par téléphone sur une période de 1 an . Les principaux objectifs de l'intervention étaient la réduction des facteurs comportementaux de risque coronaire et l'amélioration de la qualité de vie . Le programme était administré par des infirmiers spécialement formés . Le groupe témoin recevait simplement des informations écrites . Le principal résultat était le score de risque de Framingham . 297 patients ont subi des examens de suivi après 12 mois . Les patients appartenant au groupe d'intervention ont affiché des scores de risque de Framingham inférieurs à ceux du groupe témoin . Les analyses séparées par sexe révèlent que la différence porte principalement sur les hommes . Les femmes , par contre , affichent une augmentation significative des tendances dépressives/à l'anxiété , cliniquement pertinente dans le groupe témoin , contrairement au groupe d'intervention ; chez les hommes , on ne note aucune différence entre les conditions d'étude . En conclusion , le conseil téléphonique administré par des infirmiers spécialement formés semble constituer un mode économique et efficace pour parvenir à une réduction durable des facteurs de risques cardiaques et préserver les effets de la rééducation cardiaque",
"BACKGROUND There have been recent moves to extend the role of the community pharmacist to include medicine management . METHODS A r and omized controlled trial was conducted in nine sites in Engl and . Patients with coronary heart disease were identified from general practice computer systems , recruited and r and omized ( 2:1 ) to intervention or control . The 12-month intervention comprised an initial consultation with a community pharmacist to review appropriateness of therapy , compliance , lifestyle , social and support issues . Control patients received st and ard care . The primary outcome measures were appropriate treatment [ derived from the National Service Framework ( NSF ) ] , health status ( SF-36 , EQ-5D ) and an economic evaluation . Secondary outcome measures were patient risk of cardiovascular death and satisfaction . RESULTS The study involved 1493 patients ( 980 intervention and 513 control ) , 62 pharmacists and 164 GPs . No statistically significant differences between intervention and control groups were shown at follow-up for any of the primary outcome measures such as numbers on aspirin or lifestyle measures . There were few differences in quality of life ( SF-36 ) between the intervention and control groups at baseline or follow-up or with overall EQ-5D score over time . The total National Health Service cost increased between baseline and at 12 months in both groups but to a greater extent in the intervention group . Significant improvements were found in the satisfaction score for patients ' most recent pharmacy visit for prescription medicines among the intervention group , compared with control group . Self-reported compliance was good for both groups at baseline and no significant differences were shown at follow-up . CONCLUSION There was no change in the proportion of patients receiving appropriate medication as defined by the NSF . The pharmacist-led service was more expensive than st and ard care",
"BACKGROUND Despite the large body of evidence confirming the effectiveness of lipid lowering for the secondary prevention of coronary heart disease ( CHD ) events , undertreatment of hyperlipidemia is common . This study tested the effectiveness of a nurse case management program to lower blood lipids in patients with CHD . METHODS A total of 228 consecutive , eligible adults with hypercholesterolemia and CHD were recruited during hospitalization after coronary revascularization . Patients were r and omized to receive lipid management , including individualized lifestyle modification and pharmacologic intervention , from a nurse practitioner for 1 year after discharge in addition to their usual care ( NURS ) , or to usual care enhanced with feedback on lipids to their primary provider and /or cardiologist ( EUC ) . RESULTS Significantly more patients in the NURS group than in the EUC group achieved low-density lipoprotein cholesterol ( LDL-C ) levels changes in lipids and lipoproteins were accompanied by significant improvements in dietary and exercise patterns in the NURS group . In a multivariate analysis adjusting for other covariates , being assigned to the NURS group ( P = .0001 ) and being on a lipid-lowering medication ( P = .001 ) were significant independent predictors of LDL-C level . CONCLUSIONS Control of hypercholesterolemia in patients who have undergone coronary revascularization can be improved by a nurse case-management program . Because the National Cholesterol Education Program Adult Treatment Panel III guidelines have broadened the definition of high-risk population s that warrant aggressive treatment , nurse case-management programs may offer key opportunities to enhance appropriate application of new treatment paradigms",
"Aims : To evaluate the effect of a disease management programme for patients with coronary heart disease ( CHD ) and chronic heart failure ( CHF ) in primary care . Methods : A cluster r and omised controlled trial of 1316 patients with CHD and CHF from 20 primary care practice s in the UK was carried out . Care in the intervention practice s was delivered by specialist nurses trained in the management of patients with CHD and CHF . Usual care was delivered by the primary healthcare team in the control practice s. Results : At follow up , significantly more patients with a history of myocardial infa rct ion in the intervention group were prescribed a beta-blocker compared to the control group ( adjusted OR 1.43 , 95 % CI 1.19 to 1.99 ) . Significantly more patients with CHD in the intervention group had adequate management of their blood pressure ( cholesterol ( diagnosis of left ventricular systolic dysfunction confirmed ( OR 4.69 , 95 % CI 1.88 to 11.66 ) or excluded ( OR 3.80 , 95 % CI 1.50 to 9.64 ) in the intervention group compared to the control group . There were significant improvements in some quality -of-life measures in patients with CHD in the intervention group . Conclusions : Disease management programmes can lead to improvements in the care of patients with CHD and presumed CHF in primary care",
"PURPOSE Because limited audit/feedback of health status information has yielded mixed results , we evaluated the effects of a sustained program of audit/feedback on patient health and satisfaction . METHODS We conducted a group-r and omized effectiveness trial in which firms within Veterans Administration general internal medicine clinics served as units of r and omization , intervention , and analysis . Respondents to a baseline health inventory were regularly mailed the 36-Item Short Form ( SF-36 ) and , as relevant , question naires about six chronic conditions ( ischemic heart disease , diabetes , chronic obstructive pulmonary disease , depression , alcohol use , and hypertension ) and satisfaction with care . Data were reported to primary providers at individual patient visits and in aggregate during a 2-year period . RESULTS Baseline forms were mailed to 34,050 patients ; of the 22,413 respondents , 15,346 completed and returned follow-up surveys . Over the 2-year study , the difference between intervention and control groups ( as measured by difference in average slope ) was -0.26 ( 95 % confidence interval [ CI ] : -0.79 to 0.27 ; P=0.28 ) for the SF-36 Physical Component Summary score and -0.53 ( 95 % CI : -1.09 to 0.03 ; P=0.06 ) for the SF-36 Mental Component Summary score . No significant differences emerged after adjusting for deaths . There were no significant differences in condition-specific measures or satisfaction between groups after adjustment for provider type , panel size , and number of intervention visits , or after analysis of patients who completed all forms . CONCLUSION An elaborate , sustained audit/feedback program of general and condition-specific measures of health/satisfaction did not improve outcomes . To be effective , such data probably should be incorporated into a comprehensive chronic disease management program",
"BACKGROUND Previous research indicates that patients exiting a 12-week cardiac rehabilitation program ( CRP ) have difficulty maintaining an adequate exercise program . Thus , the authors ' purpose was to determine if a home-based exercise program would enable patients to maintain/improve their blood lipids , body composition , and functional capacity after exiting the CRP . METHODS Thirty-one patients exiting an initial 12-week CRP were assigned r and omly to the home-based ( HB ) intervention or the st and ard care ( SC ) condition . After one home visit , the HB participants ( n = 16 ) were contacted by telephone every other week by CRP staff and completed and returned weekly exercise logs . The SC participants ( n = 15 ) had no contact with the CRP other than to schedule follow-up tests . A third group ( n = 17 ) , r and omly selected from patients that elected to remain in the center-based CRP ( CB ) for the same duration , also were examined . All groups underwent exercise testing , fasting blood lipid analysis , and body composition assessment before starting CRP ( 0 M ) , after 3 months ( 3 M ) in a st and ard CRP , and after 9 months ( 12 M ) in either HB , SC , or CB condition ( 12 months after starting CRP ) . RESULTS Analysis of variance indicated that there were significant increases in metabolic equivalents and high-density lipoprotein , in all three groups , over time . However , analysis of covariance revealed no significant differences between the HB , SC , and CB groups at 12 M for any variable . CONCLUSIONS These data indicate that the HB program was as effective as the CB program at improving/maintaining functional capacity , blood lipids , and body weight/composition . The similar success of the SC group is likely due to their prior experience in CRP and knowledge of follow-up testing . Home-based maintenance program could be offered as a low-cost alternative to CB programs",
"Cardiac rehabilitation and subsequent intensified aftercare is capable , of increasing the rate of occupational reintegration not only over the short-term , but also over a period of two years . In addition to improving physical performance , this enhances the patient 's self-confidence , decreases anxiety and reduces depression . Since , two years after completion of cardiac rehabilitation and aftercare , the percentage of those lost to gainful employment and in need of an early pension is appreciably less in the interventional group as compared with controls , this program would appear to be of particular economic importance for social security/national insurance carriers . For this reason , the Westphalian Social Security Carrier has initiated the regular use of this concept in its cardiological hospitals",
"Abstract Objectives : To evaluate the effects of nurse led clinics in primary care on secondary prevention , total mortality , and coronary event rates after four years . Design : Follow up of a r and omised controlled trial by postal question naires and review of case notes and national data sets . Setting : Stratified , r and om sample of 19 general practice s in north east Scotl and . Participants : 1343 patients ( 673 intervention and 670 control ) under 80 years with a working diagnosis of coronary heart disease but without terminal illness or dementia and not housebound . Intervention : Nurse led secondary prevention clinics promoted medical and lifestyle components of secondary prevention and offered regular follow up for one year . Main outcome measures : Components of secondary prevention ( aspirin , blood pressure management , lipid management , healthy diet , exercise , non-smoking ) , total mortality , and coronary events ( non-fatal myocardial infa rct ions and coronary deaths ) . Results : Mean follow up was at 4.7 years . Significant improvements were shown in the intervention group in all components of secondary prevention except smoking at one year , and these were sustained after four years except for exercise . The control group , most of whom attended clinics after the initial year , caught up before final follow up , and differences between groups were no longer significant . At 4.7 years , 100 patients in the intervention group and 128 in the control group had died : cumulative death rates were 14.5 % and 18.9 % , respectively ( P=0.038 ) . 100 coronary events occurred in the intervention group and 125 in the control group : cumulative event rates were 14.2 % and 18.2 % , respectively ( P=0.052 ) . Adjusting for age , sex , general practice , and baseline secondary prevention , proportional hazard ratios were 0.75 for all deaths ( 95 % confidence intervals 0.58 to 0.98 ; P=0.036 ) and 0.76 for coronary events ( 0.58 to 1.00 ; P=0.049 ) Conclusions : Nurse led secondary prevention improved medical and lifestyle components of secondary prevention and this seemed to lead to significantly fewer total deaths and probably fewer coronary events . Secondary prevention clinics should be started sooner rather than later . What is already known on this topic Several effective interventions exist for the secondary prevention of coronary heart disease , but implementing them in practice has proved difficult Secondary prevention programmes for coronary heart disease have improved short term outcomes such as processes of care and quality of life What this study adds Short term improvements in uptake of secondary prevention produced by nurse led clinics are maintained in the longer term Improved medical and lifestyle components of secondary prevention produced by nurse led clinics seem to lead to fewer total deaths and coronary",
"This paper presents findings from the evaluation of a self-management education program based on self-regulation principles . Older men and women ( N = 324 ) were r and omly assigned to program and control groups . Outcomes were measured using the Sickness Impact Profile . Twelve months following baseline data collection , psychosocial functioning of program participants was significantly better than that of controls . Different program effects were noted when results were analyzed by participant gender",
"BACKGROUND We evaluated the effectiveness of a low-cost group visit intervention for changing the dietary intake and lipid levels of patients with known coronary artery disease ( CAD ) . METHODS We performed a controlled r and om group assignment trial in 4 community outpatient clinics . The Dietary Intervention and Evaluation Trial r and omized 97 patients with CAD to either a control group that followed the National Cholesterol Education Program 's Step II-III diet plan ( n=48 ) or an experimental group that received meal plans , recipes , and nutritional information during monthly group office sessions ( n=49 ) . Both groups received lipid-lowering medications and were followed-up over 12 months . We assessed dietary intake , fasting lipid profiles , hemoglobin A1C levels , and per member per month ( PMPM ) expense data . RESULTS Food frequency data showed that eating fruits and vegetables and cooking with monounsaturated fat increased significantly in the experimental group compared with the control group at 1 year ( P=.0072 ; P=.0001 ; P=.0004 ) . The total PMPM expenses decreased for both groups ( 38 % for the experimental group and 10 % for the control group ) , but the cost difference was statistically nonsignificant ( P=.2975 ) . Both groups noted low-density lipoprotein reductions , significant only in the experimental group ( P=.0035 ) . CONCLUSIONS Our study suggests that using group office visits for patients with CAD was an effective method for helping subjects make dietary changes and for improving lipid levels . Patients with known CAD and elevated lipid levels were willing to make significant lifestyle changes when offered a program that emphasizes healthy foods in a group visit format",
"BACKGROUND Our aim was to investigate whether a nurse-coordinated multidisciplinary , family-based preventive cardiology programme could improve st and ards of preventive care in routine clinical practice . METHODS In a matched , cluster-r and omised , controlled trial in eight European countries , six pairs of hospitals and six pairs of general practice s were assigned to an intervention programme ( INT ) or usual care ( UC ) for patients with coronary heart disease or those at high risk of developing cardiovascular disease . The primary endpoints-measured at 1 year-were family-based lifestyle change ; management of blood pressure , lipids , and blood glucose to target concentrations ; and prescription of cardioprotective drugs . Analysis was by intention to treat . The trial is registered as IS RCT N 71715857 . FINDINGS 1589 and 1499 patients with coronary heart disease in hospitals and 1189 and 1128 at high risk were assigned to INT and UC , respectively . In patients with coronary heart disease who smoked in the month before the event , 136 ( 58 % ) in the INT and 154 ( 47 % ) in the UC groups did not smoke 1 year afterwards ( difference in change 10.4 % , 95 % CI -0.3 to 21.2 , p=0.06 ) . Reduced consumption of saturated fat ( 196 [ 55 % ] vs 168 [ 40 % ] ; 17.3 % , 6.4 to 28.2 , p=0.009 ) , and increased consumption of fruit and vegetables ( 680 [ 72 % ] vs 349 [ 35 % ] ; 37.3 % , 18.1 to 56.5 , p=0.004 ) , and oily fish ( 156 [ 17 % ] vs 81 [ 8 % ] ; 8.9 % , 0.3 to 17.5 , p=0.04 ) at 1 year were greatest in the INT group . High-risk individuals and partners showed changes only for fruit and vegetables ( p=0.005 ) . Blood-pressure target of less than 140/90 mm Hg was attained by both coronary ( 615 [ 65 % ] vs 547 [ 55 % ] ; 10.4 % , 0.6 to 20.2 , p=0.04 ) and high-risk ( 586 [ 58 % ] vs 407 [ 41 % ] ; 16.9 % , 2.0 to 31.8 , p=0.03 ) patients in the INT groups . Achievement of total cholesterol of less than 5 mmol/L did not differ between groups , but in high-risk patients the difference in change from baseline to 1 year was 12.7 % ( 2.4 to 23.0 , p=0.02 ) in favour of INT . In the hospital group , prescriptions for statins were higher in the INT group ( 810 [ 86 % ] vs 794 [ 80 % ] ; 6.0 % , -0.5 to 11.5 , p=0.04 ) . In general practice s in the intervention groups , angiotensin-converting enzyme inhibitors ( 297 [ 29 % ] INT vs 196 [ 20 % ] UC ; 8.5 % , 1.8 to 15.2 , p=0.02 ) and statins ( 381 [ 37 % ] INT vs 232 [ 22 % ] UC ; 14.6 % , 2.5 to 26.7 , p=0.03 ) were more frequently prescribed . INTERPRETATION To achieve the potential for cardiovascular prevention , we need local preventive cardiology programmes adapted to individual countries , which are accessible by all hospitals and general practice s caring for coronary and high-risk patients",
"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",
"BACKGROUND Lowering plasma lipid levels in patients in the months following hospital discharge for a myocardial infa rct ion ( MI ) is clearly beneficial if recurrent cardiac events and mortality are to be prevented ; traditionally , however , there has been a large gap between guidelines and levels achieved in routine practice . OBJECTIVES AND METHODS A r and omized , open-label clinical trial was conducted to assess the impact of nurse-centred surveillance and treatment in achieving nationally recognized lipid targets in post-MI patients . This program had the following features : systematic telephone follow-up of patients discharged from the University of Sherbrooke ( Sherbrooke , Quebec ) after an MI ; systematic lipid testing three months after discharge ; close liaison with , and guidance of , patients ' primary care physicians to intervene on results of this test if targets were not obtained ; and continued monitoring of patients until lipid profiles consistent with consensus targets were achieved . The impact of this approach was tested and compared with that of a control group that continued to be followed by a primary care physician for up to 18 months . RESULTS A total of 127 patients were r and omly assigned into an intervention group ( n=64 ) or a control group ( n=63 ) . The intervention group was followed by telephone for an average ( + /-SD ) of 4.4+/-2.0 months post-MI . At this point , when intervention was optimized , the mean low-density lipoprotein cholesterol ( LDL-C ) level was 2.19+/-0.65 mmol/L in the intervention group , and 87.3 % of patients had LDL-C levels of less than 2.5 mmol/L. Patients from both experimental groups returned at 12 months and 18 months post-MI for a new blood lipid assessment . In total , 12.5 % of patients in each group were lost to follow-up . At 12 months and 18 months , the mean LDL-C level was not different between the two groups , nor was there a significant difference in the proportion of patients achieving LDL-C levels of less than 2.5 mmol/L ( 51.6 % in the intervention group and 65 % in the control group at 18 months ; P>0.05 ) . When the combined end point of an LDL-C level of less than 2.5 mmol/L , a triglyceride level of less than 2.0 mmol/L and a total cholesterol to high-density lipoprotein cholesterol ratio of less than 4.0 was considered , the proportion of patients achieving this composite at 18 months was low and not different between the two groups ( 23.4 % in the intervention group and 38.3 % in the control group ; P>0.05 ) . Over 95 % of patients in both groups were on a lipid-lowering medication , and more than 90 % had complied with their medication regimen at 18 months . CONCLUSIONS This trial did not support the role of nurse-managers and a system of telephone-based contacts to ensure the continuity of care and aggressive intervention when considering cardiovascular risk factors in post-MI patients . This trial also re-emphasized the important remaining treatment gap in secondary prevention of coronary artery disease , particularly if composite lipid end points are to be targeted"
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Although elevated systemic blood pressure ( BP ) results in high intravascular pressure , the main complications of hypertension are related to thrombosis rather than haemorrhage . It therefore seemed plausible that use of antithrombotic therapy may be useful in preventing thrombosis-related complications of elevated BP . The objectives were to conduct a systematic review of the role of antiplatelet therapy and anticoagulation in patients with BP , to address the following hypotheses : ( i ) antiplatelet agents reduce total deaths and /or major thrombotic events when compared to placebo or other active treatment ; and ( ii ) oral anticoagulants reduce total deaths and /or major thromboembolic events when compared to placebo or other active treatment . A systematic review of r and omised studies in patients with elevated BP was performed . Studies were included if they were > 3 months in duration and compared antithrombotic therapy with control or other active treatment . One meta- analysis of antiplatelet therapy for secondary prevention in patients with elevated BP reported an absolute reduction in vascular events of 4.1 % as compared to placebo . Acetylsalicylic acid ( ASA ) did not reduce stroke or ‘ all cardiovascular events ’ compared to placebo in primary prevention patients with elevated BP and no prior cardiovascular disease . Based on one large trial , ASA taken for 5 years reduced myocardial infa rct ion ( ARR , 0.5 % , NNT 200 for 5 years ) , increased major haemorrhage ( ARI , 0.7 % , NNT 154 ) , and did not reduce all cause mortality or cardiovascular mortality . In two small trials , warfarin alone or in combination with ASA did not reduce stroke or coronary events . Glycoprotein IIb/IIIa inhibitors as well as ticlopidine and clopidogrel have not been sufficiently evaluated in patients with elevated BP . To conclude for primary prevention in patients with elevated BP , antiplatelet therapy with ASA can not be recommended since the magnitude of benefit , a reduction in myocardial infa rct ion , is negated by a harm of similar magnitude , an increase in major haemorrhage . For secondary prevention in patients with elevated BP , antiplatelet therapy is recommended because the magnitude of the absolute benefit is many times greater . Warfarin therapy alone or in combination with aspirin in patients with elevated BP can not be recommended because of lack of demonstrated benefit . Further trials of antithrombotic therapy are required in patients with elevated BP
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"This study determined the effect of nonsteroidal anti-inflammatory drug ( NSAID ) administration on blood pressure in hypertensive patients taking hydrochlorothiazide ( HCTZ ) . Ninety-seven patients with mild essential hypertension and a musculoskeletal indication for NSAID use were studied in a three-phase , multi-center , double-blind , r and omized , parallel study based in 15 academic and community clinics . Patients served as their own controls . Patients with stable hypertension , not taking antihypertensive or NSAID medications , were treated with HCTZ 50 mg/day . After 4 to 5 weeks of treatment and documented stable blood pressure , naproxen 375 mg twice a day or ibuprofen 800 mg three times a day was added . Blood pressure was measured at 2 and 4 weeks of NSAID therapy . The average diastolic blood pressure was 97.5 + /- 2.4 mm Hg and the average of the mean arterial pressure ( MAP ) was 116.8 + /- 6.04 before treatment with HCTZ . Hydrochlorothiazide treatment decreased diastolic blood pressure to 83.1 + /- 5.6 mm Hg , and MAP to 101.1 + /- 6.5 mm Hg . With naproxen or ibuprofen treatments , mean diastolic blood pressure increased less than 3 mm Hg . At 2 weeks , ibuprofen increased diastolic blood pressure by 2.6 mm Hg ( P = .004 ) and naproxen increased diastolic blood pressure 0.7 mm Hg ( P = .40 ) . Both ibuprofen and naproxen significantly increased diastolic pressure at 4 weeks ( 2.1 mm Hg , P = .042 ; and 1.8 mm Hg , P = .043 , respectively ) . There was no correlation between the pre-NSAID blood pressure and the magnitude of change after 2 or 4 weeks of treatment . Changes in MAP reflected a pattern similar to diastolic pressure . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The value of anticoagulant therapy after acute myocardial infa rct ion has been assessed in 1,136 patients admitted to the Bronx Municipal Hospital Center . The treatment reduced the overall mortality in women from 31 % to 15 % , particularly those 55 years of age or over , with moderately severe infa rct ion . The low overall mortality in control men ( 16 % ) was not reduced with treatment , though there was significant reduction of the mortality in a subgroup of men with moderately severe infa rct ion showing Q-wave evolution . Age and sex , as well as the severity of the episode of acute myocardial infa rct ion , are important in determining whether anticoagulant therapy is likely to be beneficial",
"Background The clinical usefulness of intravenous thrombolytic therapy in unstable angina is currently unknown , despite the pathogenetic similarity of this entity to acute myocardial infa rct ion , for which thrombolysis has enjoyed great success . To compare the clinical benefit of intravenous urokinase with that of conventional antithrombotic therapy in preventing the progression of unstable angina to new myocardial infa rct ion , intractable angina , or death within the first 96 hours after hospitalization , 149 patients with unstable angina were r and omized to one of two intravenous thrombolytic strategies . Methods and Results Forty-nine patients received 3 million units urokinase i.v . over 90 minutes plus intravenous heparin ( group A ) ; 47 patients received unblinded 3 million units urokinase i.v . plus 325 mg aspirin p.o . daily ( group B ) ; and 53 patients received placebo thrombolytic infusion plus full-dose heparin ( group C ) . The primary end point of this trial was 96-hour clinical status . There were no significant differences in the baseline characteristics ( age , sex , previous myocardial infa rct ion , hypertension prevalence , diabetes , tobacco use , or previous revascularization ) among the three groups . Despite an excess of minor untoward reactions for the urokinase groups ( chills , 26.5 % and 23.4 % for groups A and B versus 0 % for group C ; p major bleeds ( two , none , and two for groups A , B , and C , respectively;p = NS ) . At 96 hours after presentation , no significant difference emerged in the incidence of new cardiac events : new myocardial infa rct ions developed in 10.2 % of group A , 6.4 % of group B , and 3.8 % of group C ( p = NS ) ; intractable angina occurred in 6.1 % of group A , 10.6 % of group B , and 9.4 % of group C ( p = NS ) . There were no deaths . All three groups encountered a similar incidence of overall cardiac events : 16.31 % , 17.0 % , and 13.2 % for groups A , B , and C , respectively ( p = NS ) . Although trial enrollment was to extend to 600 patients , interim analysis led to early cessation of enrollment due to a negative trend in respect to outcome after thrombolysis . Conclusions High-dose intravenous urokinase followed by either heparin or aspirin can be safely administered to a broad , unselected group of patients with unstable angina . However , this study suggests that no clinical advantage is conferred by urokinase , with either adjunctive antithrombotic therapy over st and ard heparin therapy alone , when given relatively late ( mean , 8.7 hours ) after admission for unstable angina . A possible detrimental effect can not be excluded",
"AIMS To assess the effect of tr and olapril ( 2 mg once daily ) and indomethacin ( 25 mg three times daily ) , alone and in combination , on renal function and renal functional reserve in hypertensive patients ( DBP 95 - 115 mmHg ) requiring regular non-steroidal anti-inflammatory drugs ( NSAIDs ) . METHODS R and omized , double-blind , placebo-controlled , four way crossover design . After 3 weeks treatment renal plasma flow ( RPF ) and glomerular filtration rate ( GFR ) were measured using the p-aminohippurate ( PAH ) and inulin methods . Renal functional reserve was estimated by measuring RPF and GFR at the end of an intravenous infusion of dopamine 2 microg kg(-1 ) and 10 % amino acid solution . RESULTS There was no significant difference in RPF between treatments : -22.79 ml min(-1 ) ( 95 % CI -54.82 , 9.24 ) for placebo and tr and olapril , -10.37 ml min(-1 ) ( 95 % CI -30.7 , 9.96 ) for placebo and indomethacin , -14.78 ml min(-1 ) ( 95 % CI -50.33 , 20.77 ) for placebo and tr and olapril with indomethacin . There was no significant difference in functional reserve RPF between treatments : -34.96 ml min(-1 ) ( 95 % CI -119.8 , 49.88 ) for placebo and tr and olapril , 29.78 ml min(-1 ) , -15.18 , 74.74 ) for placebo and indomethacin , and -25.84 ml min(-1 ) ( 95 % CI -87.62 , 35.94 ) for placebo and tr and olapril with indomethacin . There was no significant difference in GFR between treatments : -1.01 ml min(-1 ) ( 95 % CI -7.45 , 5.42 ) for placebo and tr and olapril , -7.88 ml min(-1 ) ( 95 % CI -15.08 , -0.68 ) for placebo and indomethacin , and -0.36 ml min(-1 ) ( 95 % CI -7.58 , 6.86 ) for placebo and tr and olapril with indomethacin . There was no significant difference in functional reserve GFR between treatments : 5.13 ml min(-1 ) ( 95 % CI -4.97 , 15.23 ) for placebo and tr and olapril , 6.31 ml min(-1 ) ( 95 % CI -1.88 , 14.5 ) for placebo and indomethacin , 7.21 ml min(-1 ) ( 95 % CI 1.26 , 13.16 ) for placebo and tr and olapril with indomethacin . CONCLUSION In hypertensives chronic treatment with NSAIDs or ACEI alone or in combination did not change RPF or GFR and did not change renal functional reserve capacity of RPF or GFR",
"BACKGROUND AND PURPOSE From a physiological perspective , physical activity might be expected to decrease the risk of developing stroke . However , epidemiological studies of physical activity and stroke risk have yielded divergent findings . We therefore sought to examine the association between exercise and stroke risk . METHODS This was a prospect i ve cohort study of 21 823 men , followed up for an average of 11.1 years . Participants were from the Physicians ' Health Study , a r and omized trial of low-dose aspirin and beta carotene . Men , aged 40 to 84 years at baseline , were free of self-reported myocardial infa rct ion , stroke , transient ischemic attack , and cancer . At baseline , they reported on the frequency of exercise vigorous enough to work up a sweat . Stroke occurrence was reported by participants and confirmed after medical record review ( n=533 ) . We used Cox proportional hazards regression to analyze the data . RESULTS With adjustment for age , treatment assignment , smoking , alcohol intake , history of angina , and parental history of myocardial infa rct ion , the relative risks of total stroke associated with vigorous exercise /=5 times per week at baseline were 1.00 ( referent ) , 0.79 ( 95 % confidence interval [ CI ] , 0.61 to 1 . 03 ) , 0.80 ( 95 % CI , 0.65 to 0.99 ) , and 0.79 ( 95 % CI , 0.61 to 1.03 ) , respectively ; P for trend=0.04 . In subgroup analyses , the inverse association appeared stronger with hemorrhagic than ischemic stroke . When we additionally adjusted for body mass index , history of hypertension , high cholesterol , and diabetes mellitus , corresponding relative risks for total stroke were 1.00 ( referent ) , 0.81 ( 95 % CI , 0.61 to 1.07 ) , 0.88 ( 95 % CI , 0.70 to 1.10 ) , and 0.86 ( 95 % CI , 0.65 to 1.13 ) , respectively ; P for trend=0.25 . CONCLUSIONS Exercise vigorous enough to work up a sweat is associated with decreased stroke risk in men . In the present study , the inverse association with physical activity appeared to be mediated through beneficial effects on body weight , blood pressure , serum cholesterol , and glucose tolerance . Apart from its favorable influences on these variables , physical activity had no significant residual association with stroke incidence",
"To evaluate the influence of salt sensitivity on the blood pressure response to oral indomethacin treatment , we studied 35 hospitalized essential hypertensive patients ( 24 men and 11 women , aged from 40 to 55 years ) . During a normal NaCl intake ( 120 mmol Na+ per day ) , patients were assigned to receive in a r and omized double-blind fashion either 200 mg indomethacin ( 25 patients ) or placebo ( 10 patients ) for 5 days . Two weeks after the interruption of indomethacin treatment , during which the normal NaCl intake was continued , salt sensitivity was assessed by giving each patient a high ( 220 mmol Na+ per day for 10 days ) and then a low ( 20 mmol Na+ per day for 10 days ) NaCl diet . Blood pressure changes were evaluated , and the measurement taken at the end of the 2 weeks under normal sodium intake was considered baseline blood pressure . Patients were classified as salt sensitive when a diastolic blood pressure change of 10 mm Hg or more occurred after both low and high periods of sodium intake . In salt-resistant patients treated with indomethacin ( n = 12 , nine men and three women , mean age 50.5 + /- 3.7 years ) , neither blood pressure ( systolic blood pressure from 150.8 + /- 11.2 to 154.6 + /- 9.3 mm Hg , NS ; diastolic blood pressure from 99.3 + /- 2.1 to 101.1 + /- 4.4 mm Hg , NS ) nor the urinary Na+ excretion ( from 108.1 + /- 20.9 to 97.9 + /- 9.1 mmol/24 hr , NS ) was significantly affected by the drug . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Twenty four male hypertensive patients suffering also from peripheral obstructive arterial disease were r and omly subdivided in two groups and after a period of farmacological wash-out of one month Group I was treated with Captopril ( C 50 mg bid ) or Ticlopidine ( T 250 mg bid ) for three months and then with the association C plus T for three months again . After placebo administration for one month , patients were further treated with C plus T at low doses ( 25 mg bid and respectively 250 mg daily ) . In the first part of the study , patients of Group II received an inverse sequence of the drugs ( before Ticlopidine 250 mg bid and then Captopril 50 bid ) . In both groups of patients C induced a significant decrease of blood pressure and an increase of PFWD , TWD , and WI . T did not modify blood pressure but slightly increased PFWD , TWD , and WI . The improvement was more evident during administration of C plus T , whereas placebo administration induced a trend toward baseline values . Finally , the chronic administration of C plus T for twelve months induced a further improvement of all considered parameters . In conclusion , chronic administration of C plus T may be useful in the treatment of hypertensive patients suffering from intermittent claudication , improving significantly PFWD and TWD",
"BACKGROUND Despite the use of aspirin , there is still a risk of ischaemic events after percutaneous coronary intervention ( PCI ) . We aim ed to find out whether , in addition to aspirin , pretreatment with clopidogrel followed by long-term therapy after PCI is superior to a strategy of no pretreatment and short-term therapy for only 4 weeks after PCI . METHODS 2658 patients with non-ST-elevation acute coronary syndrome undergoing PCI in the CURE study had been r and omly assigned double-blind treatment with clopidogrel ( n=1313 ) or placebo ( n=1345 ) . Patients were pretreated with aspirin and study drug for a median of 6 days before PCI during the initial hospital admission , and for a median of 10 days overall . After PCI , most patients ( > 80 % ) in both groups received open-label thienopyridine for about 4 weeks , after which study drug was restarted for a mean of 8 months . The primary endpoint was a composite of cardiovascular death , myocardial infa rct ion , or urgent target-vessel revascularisation within 30 days of PCI . The main analysis was by intention to treat . FINDINGS There were no drop-outs . 59 ( 4.5 % ) patients in the clopidogrel group had the primary endpoint , compared with 86 ( 6.4 % ) in the placebo group ( relative risk 0.70 [ 95 % CI 0.50 - 0.97 ] , p=0.03 ) . Long-term administration of clopidogrel after PCI was associated with a lower rate of cardiovascular death , myocardial infa rct ion , or any revascularisation ( p=0.03 ) , and of cardiovascular death or myocardial infa rct ion ( p=0.047 ) . Overall ( including events before and after PCI ) there was a 31 % reduction cardiovascular death or myocardial infa rct ion ( p=0.002 ) . There was less use of glycoprotein IIb/IIIa inhibitor in the clopidogrel group ( p=0.001 ) . At follow-up , there was no significant difference in major bleeding between the groups ( p=0.64 ) . INTERPRETATION In patients with acute coronary syndrome receiving aspirin , a strategy of clopidogrel pretreatment followed by long-term therapy is beneficial in reducing major cardiovascular events , compared with placebo",
"BACKGROUND When a patient survives thrombolysis for acute myocardial infa rct ion , little information from large studies exists from which to estimate prognosis during follow-up visits . METHODS AND RESULTS Baseline , in-hospital , and later survival data were collected from 41 021 patients enrolled in Global Utilization of Streptokinase and TPA for Occluded Coronary Arteries , a r and omized trial of 4 thrombolytic-heparin regimens with st and ard aspirin and beta-blockade . Cox proportional hazards models were developed to predict 1-year survival in 30-day survivors ( n=37 869 ) from baseline clinical and ECG factors and in-hospital factors ; a combined model then was developed ( C-index 0.800 ) . The model was simplified into a nomogram to predict individual outcomes ( C-index 0.754 ) . Factors reflecting demographics ( advanced age , lighter weight ) , larger infa rct ions ( higher Killip class , lower blood pressure , faster heart rate , longer QRS duration ) , cardiac risk ( smoking , hypertension , prior cerebrovascular disease ) , and arrhythmia were important predictors of death between 30 days and 1 year . Black race was associated with a substantial increase in risk after considering other factors . Revascularization was associated with reduced risk between 30 days and 1 year . CONCLUSIONS When evaluating a patient who has survived acute infa rct ion treated with thrombolysis , clinicians can estimate the likelihood of survival from factors easily measured during admission . Although many risk factors clearly relate to age , left ventricular dysfunction , or clinical instability , black race is an unexplained risk factor requiring further examination",
"Summary In postmyocardial infa rct ion patients longterm aspirin treatment with 1.5 g/day led to a significant increase in systolic and diastolic blood pressure after 6 months . This could not be found in the placebo- and the phenprocoumon-treated patients . After one year the blood pressure behaviour was the same in all three treatment groups . As nonsteroidal antirheumatic drugs can produce hypertension in animals , probably due to inhibition of prostagl and in synthesis , blood pressure control in longterm aspirin treatment is advisable . ZusammenfassungNach 6 Monaten Therapie mit 1,5 g Acetylsalizylsäure täglich wurde bei Postinfarkt-Patienten ein signifikanter Anstieg des systolischen und diastolischen Blutdrucks beobachtet . Ein solches Ansteigen des Blutdrucks konnte bei den mit Placebo oder Phenprocoumon Beh and elten nicht nachgewiesen werden . Ein Jahr nach Therapiebeginn war das Blutdruckverhalten gleich in allen drei Therapiegruppen . Da auch bei Tieren mit nichtsteroidalen Antirheumatika ein Hochdruck erzeugt werden konnte , wahrscheinlich durch Hemmung der Prostagl and insynthese , ist die regelmäßige Blutdruckkontrolle während einer Langzeit-Aspirin-Therapie ratsam",
"Arthritis and hypertension are frequent comorbidities in the elderly hypertensive population . Nonsteroidal anti-inflammatory drugs are often used to relieve pain in arthritic patients but a side effect is sodium retention and consequent elevation of blood pressure ( BP ) . The effect of dihydropyridine calcium blocking drugs is relatively independent of sodium intake , whereas the angiotensin-converting enzyme ( ACE ) inhibitors ' effects can be blunted by a high-sodium diet . This study compared the effects of indomethacin with placebo in elderly patients with essential hypertension who had been controlled with amlodipine or enalapril . Indomethacin 50 mg twice daily or placebo was administered for 3 weeks in a double-blind crossover study to patients controlled with amlodipine or enalapril . The response was assessed by ambulatory BP measurement . Indomethacin raised BP and lowered pulse rates in patients taking enalapril but had little effect in patients receiving amlodipine . The difference caused by indomethacin between the two groups was 10.1/4.9 mm Hg increase in BP and a 5.6 beats/min fall in pulse in people taking enalapril . Addition of indomethacin to patients taking either drug caused a rise in weight and a fall in plasma renin . It is postulated that the effect is due to inhibition of prostagl and in synthesis , which causes sodium retention . In patients taking amlodipine , the fall in plasma renin ameliorates the effect of sodium retention on BP . In patients taking enalapril , plasma renin falls but this is not translated into an effect because of the blockage of converting enzyme . Thus , the full effect of sodium retention on BP is expressed . In patients treated with indomethacin , fewer patients may respond to ACE inhibitors . However , the major problem is the patient who intermittently takes indomethacin or other nonsteroidal anti-inflammatory drugs , which , if a person is treated by an ACE inhibitor causes BP to go out of control . In such patients amlodipine would appear to be a preferred choice to enalapril",
"Background — Patients with a non – ST-elevation acute coronary syndrome and prior CABG are at high risk of a recurrent ischemic event despite aspirin therapy . This trial investigated the potential benefit of secondary prevention with warfarin . Methods and Results —In a double-blind r and omized trial , 135 patients with unstable angina or non – ST-segment elevation myocardial infa rct ion , with prior CABG , and who were poor c and i date s for a revascularization procedure received therapy with aspirin and placebo+warfarin , warfarin and placebo+aspirin , or aspirin and warfarin for 12 months . Warfarin was titrated to an international normalized ratio of 2.0 to 2.5 . The primary end point ( death or myocardial infa rct ion or unstable angina requiring hospitalization 1 year after r and omization ) occurred in 14.6 % of the patients in the warfarin-alone group , in 11.5 % of patients in the aspirin-alone group , and in 11.3 % of patients r and omized to the combination therapy ( P = 0.76 ) . Subgroup analyses by risk features provided no indications that warfarin alone or in combination with aspirin could be of benefit over aspirin alone . Bleeding was more frequent in the 2 groups of patients administered warfarin . Conclusions —Moderate-intensity oral anticoagulation alone or combined with low-dose aspirin does not appear to be superior to low-dose aspirin in the prevention of recurrent ischemic events in patients with non – ST-elevation acute coronary syndromes and previous CABG",
"This study investigates the possible effects of acetylsalicylic acid ( ASA ; aspirin ) on systolic ( S ) and diastolic ( D ) blood pressure ( BP ) in healthy and mildly hypertensive subjects receiving ASA at different times according to their rest-activity cycle . A double-blind , r and omized , controlled trial was conducted in 73 healthy young adult volunteers and 18 previously untreated subjects with mild hypertension . The BP of each subject was automatically monitored every 30 minutes for 48h before the trial and at the end of a one-week course of placebo and a one-week course of ASA . Healthy volunteers were r and omly assigned to one of six groups , defined according to the dose of ASA ( either 500 mg/day , the usual commercial dose ; or 100 mg/day ) and timing of ASA and placebo ( within 2h after awakening , Time 1 ; 7h to 9h after awakening , Time 2 ; or within 2h of bedtime , Time 3 ) . Subjects with mild hypertension received the low dose of 100 mg/day ASA , as well as one week of placebo , and were r and omly assigned to one of the same three groups defined above according to the time of treatment . A small ( approximately 2 mmHg in the 24h mean of SBP ) , but statistically significant , BP reduction was found when 500 mg/day ASA was given to healthy volunteers at Time 2 . With 100 mg/day , the effect of ASA in healthy subjects was comparable to the BP reduction found with the higher dose for Time 2 ; there was again no effect on BP at Time 1 , but we found a statistically significant effect at Time 3 ( 2.3 mmHg reduction in the 24h mean of SBP ) , larger than for Time 2 . For hypertensive patients , the BP reduction was again statistically significant for Time 2 and , to a greater extent , for Time 3 ( approximately 4.5 mmHg for both SBP and DBP ) ; all patients in these two groups showed a BP reduction after one week of ASA . The effect was about three times as large as the BP reduction obtained in healthy subjects treated with 100 mg/day ASA . Results indicate a statistically significant time- and dose-dependent effect of ASA on BP . In any meta- analysis of ASA effects , inquiries about the time when subjects took the drug are indicated and may account for discrepancies in the literature . Moreover , the influence of ASA on BP demonstrated here indicates the need to identify and control for ASA effects in patients using ASA before and during their participation in antihypertension medication trials",
"OBJECTIVE Nonsteroidal antiinflammatory drugs ( NSAID ) have been associated with hemodynamically mediated acute renal failure . There appear to be differences among NSAID in producing this effect . We compare renal effects of ibuprofen , sulindac , and nabumetone . METHODS Seventeen women over age 56 receiving hydrochlorothiazide and fosinopril for hypertension who had osteoarthritis requiring NSAID received 3 different NSAID to evaluate potential varying renal effects . In an investigator blinded r and omized study , patients received nabumetone , sulindac , or ibuprofen for 1 month with intervening 2 week control periods . After each period renal function was assessed by inulin and para-aminohippurate clearances and urinary prostagl and ins were measured . RESULTS No overall statistical differences among the NSAID were observed . However , there were clinical ly meaningful differences during ibuprofen therapy : 4 patients developed a clinical ly significant decrease in renal function ; during sulindac therapy one of these also developed a clinical ly significant decrease in renal function . During nabumetone there were 0 episodes of clinical ly significant decrease in renal function . Using Gomez equations , glomerular hydrostatic pressure and afferent and efferent arteriolar resistances were estimated . None changed overall during any intervention . However , the 4 patients who developed decreased renal function while taking ibuprofen were analyzed separately . Glomerular hydrostatic pressure decreased 15 % ; afferent arteriolar resistance increased 85 % . These changes were associated with marked decreases in vasodilatory prostagl and ins compared to patients receiving ibuprofen who did not develop decreases in renal function . CONCLUSION There are differences in effect on renal function among NSAID . These can be correlated with specific alterations in suppression of the cyclooxygenase system cascade and related to changes in the hemodynamic control of glomerular filtration",
"BACKGROUND Nonsteroidal anti-inflammatory drugs may attenuate the antihypertensive effects of diuretics , beta-blockers , angiotensin-converting enzyme inhibitors , central alpha-agonists , and other vasodilators . Their effects on the antihypertensive efficacy of calcium channel blockers are inadequately studied in small numbers of patients but appear to be minimal . METHODS A three-phase , r and omized , double-blind , placebo-controlled multicenter study included 162 patients aged 18 to 75 years with essential hypertension . After diastolic blood pressure was controlled to 90 mm Hg or less with once-daily verapamil hydrochloride , patients received ibuprofen , naproxen , or placebo matching capsules for 3 weeks , and blood pressure , heart rate , weight , and adverse effects were evaluated . A general linear model with 95 % confidence intervals was used to compare each nonsteroidal anti-inflammatory drug treatment group with the placebo group . RESULTS No significant differences in sitting , st and ing , or supine blood pressure were noted with naproxen or ibuprofen compared with placebo . The percentages of patients in each treatment group with increases of 10 mm Hg or more in either systolic or diastolic blood pressure were similar . Statistically significant increases in weight were seen with both nonsteroidal anti-inflammatory drug therapies . Changes in pulse rate were not significant . The incidence of adverse effects was similar across all three treatment groups . CONCLUSIONS The addition of naproxen or ibuprofen to the treatment of hypertensive patients in whom blood pressure is controlled by once-daily verapamil does not cause an increase in blood pressure . Verapamil may therefore offer considerable advantages in maintaining control of blood pressure in patients who regularly receive nonsteroidal anti-inflammatory drug therapy",
"1 . The effects of non-steroidal anti-inflammatory drugs ( NSAID ) on prostacyclin and thromboxane bio synthesis and on blood pressure were determined in 46 patients with mild essential hypertension . Patients who had abstained from antihypertensive therapy for 2 weeks before study were treated with either aspirin , ibuprofen , sulindac or placebo for 7 days . 2 . Excretion rates of 2,3-dinor-6-oxo-prostagl and in ( PG ) F1 alpha , 6-oxo-PGF1 alpha , 2,3-dinorthromboxane ( TX ) B2 and TXB2 were measured as indices of prostacyclin and TXA2 bio synthesis . Sample s were assayed using immunoaffinity chromatography and gas chromatography/electron capture chemical ionisation mass spectrometry . 3 . Aspirin and ibuprofen reduced urinary excretion of all prostacyclin- and thromboxane-derived products . Sulindac inhibited excretion of 2,3-dinor-6-oxo-PGF1 alpha , 6-oxo-PGF1 alpha and 2,3-dinor-TXB2 , but had no significant effect on TXB2 . 4 . Systolic blood pressure increased in the ibuprofen-treated group when compared with the placebo group . There were no other significant changes in systolic or diastolic pressure in any of the treatment groups . Among the patients as a whole , there was a significant negative correlation between change in blood pressure and change in excretion of the prostacyclin-derived but not of the thromboxane-derived products . 5 . We conclude that , in patients with mild essential hypertension , neither sulindac nor aspirin ( in the doses used ) selectively spares prostacyclin bio synthesis by the kidney . The significant relationship between increase in blood pressure and reduction in prostacyclin bio synthesis favours the possibility that in individuals who become hypertensive , prostacyclin bio synthesis determines , in part , the severity of the hypertensive state",
"BACKGROUND An inverse association between moderate alcohol consumption and coronary heart disease ( CHD ) has been observed in several epidemiological studies . To assess whether a similar association exists among diabetics , we examined the relation between light to moderate alcohol consumption and CHD in men with and without diabetes mellitus in a prospect i ve cohort study . METHODS AND RESULTS A total of 87 938 US physicians ( 2790 with diagnosed diabetes mellitus ) who were invited to participate in the Physicians ' Health Study and were free of myocardial infa rct ion , stroke , cancer , or liver disease at baseline were followed for an average of 5.5 years for death with CHD as the underlying cause . During 480 876 person-years of follow-up , 850 deaths caused by CHD were documented : 717 deaths among nondiabetic men and 133 deaths among diabetic men . Among men without diabetes at baseline , the relative risk estimates for those reporting rarely/never , monthly , weekly , and daily alcohol consumption were 1.00 ( referent ) , 1.02 , 0 . 82 , and 0.61 ( 95 % CI 0.49 to 0.78 ; P for trend Among men with diabetes at baseline , the relative risk estimates were 1.00 ( referent ) , 1.11 , 0.67 , and 0.42 ( 95 % CI 0.23 to 0.77 ; P for trend=0.0019 ) . CONCLUSIONS These results suggest that light to moderate alcohol consumption is associated with similar risk reductions in CHD among diabetic and nondiabetic men",
"Objective The objective of this study was to provide a comprehensive comparison of the long term safety and tolerability of clopidogrel , a new adenosine diphosphate ( ADP ) receptor antagonist that inhibits platelet activation induced by ADP , and aspirin ( acetylsalicylic acid ) . Patients and Methods The study population comprised 19 185 patients with symptomatic atherosclerosis manifested as recent ischaemic stroke , recent myocardial infa rct ion or symptomatic peripheral arterial disease . Patients were r and omised to receive clopidogrel 75 mg/day or aspirin 325 mg/day for a minimum of 1 year and a maximum of 3 years . Results Compared with aspirin , clopidogrel reduced the combined risk of ischaemic stroke , myocardial infa rct ion or vascular death by 8.7 % ( p = 0.043 ) . The incidence of early permanent discontinuations of the study drug due to adverse events was almost identical in both treatment groups ( 11.94 % for clopidogrel vs 11.92 % for aspirin ) . Reported neutropenia was similar in the clopidogrel and aspirin groups ( 0.10 vs 0.17 % , respectively ) with corresponding rates ( 0.05 vs 0.04 % , respectively ) for severe neutropenia . Thrombocytopenia was identical in the clopidogrel and aspirin groups ( 0.26 % ) , with the rates of severe thrombocytopenia being 0.19 vs 0.10 % , respectively . None of these observed differences was statistically significant . The overall incidence of haemorrhagic events did not differ statistically significantly between treatment groups ( 9.27 % for clopidogrel vs 9.28 % for aspirin ; p = 0.98 ) . There was a trend towards a lower incidence of intracranial haemorrhage in the clopidogrel group ( 0.31 % ) compared with the aspirin group ( 0.42 % ) . Any reported gastrointestinal haemorrhage was significantly less frequent with clopidogrel ( 1.99 % ) than with aspirin ( 2.66 % ) [ p severe gastrointestinal bleeding were 0.49 vs 0.71 % ; p gastrointestinal adverse events with clopidogrel than with aspirin ( 27.1 vs 29.8 % ; p abdominal pain , dyspepsia , constipation , or peptic , gastric , or duodenal ulceration with clopidogrel . Diarrhoea was significantly more common in the clopidogrel group ( 4.46 vs 3.36 % ; p severe diarrhoea ( 0.23 vs 0.11 % ) was low and was not significantly different between groups . There were significantly more patients with rash in the clopidogrel group ( 6.0 % ) compared with the aspirin group ( 4.6 % ) [ p clopidogrel represents a clinical ly important advance in the treatment of patients with manifest atherosclerotic disease",
"Nonsteroidal antiinflammatory drugs ( NSAID ) are frequently reported to interfere with the blood pressure lowering actions of various antihypertensive medications . We studied 17 women with arthritis and hypertension who were receiving fosinopril and HCTZ , and administered sequentially in r and om order ibuprofen , sulindac , and nabumetone for 1 month each , with an intervening 2-week washout period between each treatment period . During the washout period , subjects received acetaminophen . Blood pressure at the end of 2 weeks of acetaminophen was compared with blood pressure after 1 month of treatment with each of the NSAID . Mean blood pressure was unchanged before and after all NSAID : 108 + /- 7 v 107 + /- 9 for nabumetone , 108 + /-9 v 108 + /- 9 for sulindac , and 108 + /- 8 v 107 + /- 9 for ibuprofen . The 24-h urinary sodium excretion was not significantly different . We conclude that the three NSAID did not neutralize the antihypertensive effect of the combination of fosinopril and HCTZ , and hence the blood pressure lowering action of the combination may not be prostagl and in dependent",
" From 1979 - 85 , 2435 patients with a transient ischaemic attack or minor ischaemic stroke were r and omly allocated to receive long term \" blind \" treatment with aspirin 600 mg twice daily ( n = 815 ) , aspirin 300 mg once daily ( n = 806 ) or placebo ( n = 814 ) . No patient was lost to follow up . The \" intention to treat \" comparison included all the serious vascular events and deaths which occurred before the end of the follow up period on 30 September 1986 . There was no difference in efficacy between the 300 mg and 1200 mg daily doses of aspirin , but the lower dose was undoubtedly less gastrotoxic . Also , there was no definite difference in the response of males and females to aspirin . The odds of suffering a major stroke , myocardial infa rct ion or vascular death were 15 % less in the combined aspirin groups compared with the placebo group ( 95 % confidence interval 29 % reduction to 3 % increase in odds ) which is compatible with the continuing overview of all the similar trials of antiplatelet drugs where the relative reduction in odds was 25 % . There was no statistically significant reduction in the likelihood of either disabling major stroke and vascular death or vascular death occurring",
"Effect of non-steroidal anti-inflammatory drug ( NSAID ) on blood pressure ( BP ) control was evaluated in elderly hypertensive patients treated with calcium antagonist . The study was based on a r and omized , crossover design to compare the effect of an NSAID , sulindac , with that of another NSAID , diclofenac sodium , in the hypertension treatment . The study was completed in six elderly female subjects ( the average age : 66 + /- 3 year ) whose systolic BP and diastolic BP were more than 160 mmHg and more than 95 mmHg , respectively . When BP was controlled by nifedipine ( 20 mg x 2 per day in slow releasing form ) within normal limits , sulindac ( 100 mg x 3 per day ) or diclofenac sodium ( 25 mg x 3 per day ) was administered for a week . After one week-washout period , the other NSAID was substituted . Plasma and urinary variables were measured on the final day of each study period . The average systolic BP and diastolic BP and the entry of study were 167 + /- 5 mmHg and 93 + /- 5 mmHg , respectively . Nifedipine significantly decreased the systolic BP to 140 + /- 4 mmHg ( p less than 0.02 ) and the diastolic BP to 84 + /- 4 mmHg ( p less than 0.05 ) . Addition of either sulindac or diclofenac sodium did not affect BP , whereas urinary PGE2 excretion and plasma renin activity were significantly inhibited . Plasma creatinine and electrolyte concentration were not changed by the NSAIDs . The results indicate that either sulindac or diclofenac sodium does not interfere with control of hypertension by a calcium antagonist , nifedipine in in elderly hypertensive patients . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND In a retrospective study , antiplatelet therapy has been shown to be associated with a decreased incidence of erythropoietin-induced hypertension . In order to ascertain the role of antiplatelet drugs in the haemodynamic response to the correction of anaemia by rHuEpo , 18 patients on chronic haemodialysis who started rHuEpo therapy were prospect ively studied . METHODS The subjects were r and omly assigned to receive or not , one of the following antiplatelet drugs : ditazole ( 3 patients ) , ticlopidine ( 3 patients ) or aspirin plus dipyridamole ( 3 patients ) . Cardiac index ( CI ) by echo-Doppler , total peripheral resistance ( TPR ) and mean arterial pressure ( MAP ) were determined at baseline 10 and 20 weeks following the initiation of rHuEpo therapy . rHuEpo therapy was administered subcutaneously at the same dose ( 40 U/kg thrice weekly ) during the first 10 weeks . Ten uraemic patients on haemodialysis who had never received rHuEpo therapy served as the control group . RESULTS One patient in the group without antiplatelet drugs discontinued the study due to the development of severe hypertension after 12 weeks on rHuEpo therapy . There were no significant differences in the haemodynamic parameters at baseline . At 10 weeks , MAP was higher in patients without than with antiplatelet drugs or controls untreated with rHuEpo ( 128.5 + /- 28 versus 100.6 + /- 13.5 versus 98.7 + /- 14 mmHg respectively , P = 0.0047 ) , TPR was also higher in patients without antiplatelet drugs than in the 2 other groups ( 1919 + /- 433 versus 1576 + /- 359 versus 1418 + /- 324 din.seg.cm-5m2 respectively , P = 0.0231 ) , but CI did not differ among the three groups . At 20 weeks , MAP was still higher in patients without antiplatelet drugs than in patients with antiplatelet drugs or controls not on rHuEpo therapy respectively ( 112.9 + /- 24.6 versus 91.0 + /- 9.0 versus 101.7 + /- 14.1 mmHg respectively , P = 0.075 ) , but at this stage TPR and Cl did not differ among the three groups . CONCLUSIONS These data reinforce the previous observation that antiplatelet therapy may prevent the development of rHuEpo-induced hypertension",
"The Coumadin Aspirin Reinfa rct ion Study demonstrated that combination treatment with fixed dose warfarin ( 1 or 3 mg ) + aspirin 80 mg was not superior to aspirin 160 mg alone after myocardial infa rct ion for reducing nonfatal reinfa rct ion , nonfatal stroke , and cardiovascular death . In this analysis , we examined the importance of aspirin dose in the protection against the secondary end point of ischemic stroke . The comparison arms for this analysis were warfarin 1 mg + aspirin 80 mg versus aspirin 160 mg . In the Coumadin Aspirin Reinfa rct ion Study , 2,028 patients were r and omized to aspirin 80 mg plus warfarin 1 mg , and 3,393 were r and omized to aspirin 160 mg alone . A predictive model for ischemic stroke was developed using the Cox proportional-hazards model . A reduced Cox proportional-hazards model was developed to test for the effect of aspirin dose on ischemic stroke in predefined subgroups . The incidence of ischemic stroke was lower in patients treated with aspirin 160 mg than in patients treated with aspirin 80 mg + warfarin 1 mg ( 0.6 % vs 1.1 % ; p = 0.0534 ) . Age , previous stroke or transient ischemic attack , and aspirin dose were independent predictors of ischemic stroke . In addition , the highest risk patients , those with Q-wave myocardial infa rct ion and male patients , appeared to receive greater benefit from aspirin 160 mg than from aspirin 80 mg + warfarin 1 mg . The results of this secondary analysis suggest that aspirin 160 mg is more effective than aspirin 80 mg + warfarin 1 mg in preventing ischemic stroke in post-myocardial infa rct ion patients",
"To determine whether endothelin-1 ( ET-1 ) contributes to hypertension associated with non-steroidal anti-inflammatory drug ( NSAID ) usage in healthy , elderly , normotensive individuals a r and omised , double-blind , placebo-controlled , crossover trial of indomethacin was undertaken in 41 healthy , elderly individuals with stable normotension or controlled hypertension ( blood pressure ( BP ) The main outcome measures were systolic and diastolic BP , heart rate , cardiac output , weight , creatinine clearance , plasma renin activity , aldosterone , endothelin-1 and arginine vasopressin concentrations and 24 h urinary endothelin-1 and 6 keto prostagl and in F1 alpha outputs . Analysis of covariance was used to evaluate the effect of indomethacin on BP and related parameters . Indomethacin treatment for 1 month increased systolic ( + /- s.e.m . : 4.1 + /- 2.2 mm Hg ; 95 % confidence interval 0 to 8.3 mm Hg ) and diastolic BP ( 2.7 + /- 1.1 mm Hg ; 0.4 to 4.9 mm Hg ) without altering cardiac output ( P = 0.59 ) , implying an increase in total peripheral resistance . Indomethacin treatment produced a small increase in weight ( 1.4 + /- 0.4 kg ; 0.6 to 2.2 kg ) , a small reduction in renal function ( creatinine clearance : 6.8 + /- 1.8 mis/min ; 3.3 to 10.3 mis/min ) but a significant ( 83 % ) increase in daily urinary endothelin-1 production ( 13.1 + /- 3.4 ng/ml ; 6.4 to 19.8 ng/ml ) without altering plasma ET-1 concentration , suggesting increased renal synthesis . In conclusion , renal paracrine effects of ET-1 may contribute to NSAID-induced blood pressure elevation in humans",
"Objective : To assess the relationship between chronic intake of nonsteroidal anti-inflammatory drugs ( NSAID ) and outcome , in particular ( gastrointestinal ) bleeding and to investigate whether the effect of chronic NSAID intake was similar in untreated and treated elderly hypertensives . Methods : Eligible patients ( ⩾60 years , with systolic blood pressure 160–219 mm Hg and diastolic blood pressure were r and omised to active treatment or placebo . Active treatment consisted of nitrendipine , with the possible addition of enalapril , hydrochlorothiazide , or both , titrated or combined to reduce the sitting systolic blood pressure by at least 20 mm Hg to below 150 mm Hg . Patients never taking NSAIDs ( n = 2882 ) were compared with patients on chronic NSAID intake ( n= 861 ) , defined as reporting NSAID intake on at least 50 % of the patient forms . Results : There was a tendency towards lower mortality ( relative hazard rate ( 95 % confidence interval ( CI ) , 0.77 ( 0.56–1.06 ) ) and higher incidence of bleeding ( 1.13 ( 0.63–2.05 ) with chronic NSAID intake . Although there was no significant interaction between calcium-channel blocker (CCB)-based treatment and chronic NSAID intake for any of the end points , chronic NSAID intake tended to be associated with a lower incidence of bleeding on active treatment as compared to placebo ( P-value of the interaction term = 0.07 ) . Conclusion : The effect of chronic NSAID intake on outcome was similar in patients on active treatment based on a dihydropyridine CCB or on placebo . However , chronic NSAID intake might have a less deleterious effect on bleeding on active treatment as compared to placebo",
"BACKGROUND When administered intravenously at the time of percutaneous coronary revascularization , glycoprotein IIb/IIIa receptor antagonists decrease the incidence of death and nonfatal myocardial infa rct ion and the need for urgent revascularization . We hypothesized that long-term administration of oral glycoprotein IIb/IIIa antagonists , which block the aggregation of platelets , might stabilize intravascular plaque and prevent additional ischemic cardiac events . METHODS We conducted a prospect i ve , double-blind trial in which 7232 patients were r and omly assigned to receive 20 mg of oral xemilofiban or placebo 30 to 90 minutes before undergoing percutaneous coronary revascularization , with maintenance doses of 10 or 20 mg of xemilofiban or placebo administered three times daily for up to 182 days . There were two primary composite end points : one was death , nonfatal myocardial infa rct ion , or urgent revascularization at 182 days , and the other was death or nonfatal myocardial infa rct ion at 182 days . RESULTS Death , myocardial infa rct ion , or urgent revascularization occurred within 182 days in 324 patients who received placebo ( Kaplan-Meier cumulative event rate , 13.5 percent ) , 332 who received 10 mg of xemilofiban ( 13.9 percent , P=0.82 for the comparison with placebo ) , and 306 who received 20 mg of xemilofiban ( 12.7 percent , P=0.36 for the comparison with placebo ) . The incidence of death or myocardial infa rct ion was also similar in all three groups . Clinical ly significant hemorrhagic complications and thrombocytopenia were infrequent . CONCLUSIONS The administration of the glycoprotein IIb/IIIa antagonist xemilofiban before percutaneous coronary revascularization and for up to six months thereafter does not significantly reduce the incidence of important clinical end points",
"OBJECTIVE To evaluate in hypertensive patients whether or not the sodium-retaining effects of indomethacin can explain the indomethacin-induced attenuation of enalapril antihypertensive effects . DESIGN R and omized , single-blinded , placebo controlled study with a placebo phase ( 2 weeks ) followed by enalapril 20 mg/d ( 4 weeks , once daily ) and enalapril 20 mg + indomethacin 75 mg/d ( 1 week ) . Enalapril dose increased up to 40 mg/d if inadequate response to 20 mg . PATIENTS Twenty-four patients with mild-moderated hypertension , showing an adequate response to enalapril ( 20 - 40 mg/d ) . METHODS Blood pressure evaluated by \" casual \" methods and by 24-hour ambulatory blood pressure monitoring , measurement of 24-hour urinary sodium excretion and fractional excretion of sodium : at the end of placebo , enalapril and enalapril + indomethacin treatments . Determination of the correlations between the changes induced by indomethacin ( when added to enalapril ) on the blood pressure and on sodium excretion effects of enalapril . RESULTS Enalapril significantly reduced casual blood pressure ( systolic/diastolic ) by 33/18 mmHg and 24-hour blood pressure by 20/9 mmHg . When added to enalapril , indomethacin attenuated ( by 50 % ) the antihypertensive effects of enalapril and significantly decreased the 24-hour ( from 120 + /- 11 mmol to 106 + /- 10 mmol ) and fractional excretion of sodium ( from 1.11 + /- 0.09 % to 0.75 + /- 0.06 % ) . However , the indomethacin-induced attenuation of enalapril hypotensive effects did not correlate with indomethacin-induced changes of sodium excretion . CONCLUSIONS When indomethacin is administrated to hypertensive patients that are well controlled with enalapril , it produces a marked attenuation of enalapril hypotensive effects and produces sodium retention . However , the amount of the attenuation of the hypotensive effects of enalapril by indomethacin are completely independent of the amount of the indomethacin-induced sodium retention . These results suggest that the mechanisms involved in interaction between both drugs at the blood pressure domain are probably localized at an extra-renal level",
"To determine the renovascular effects of nonprescription ibuprofen in the maximum labeled over-the-counter ( OTC ) dosage for 7 days , and to compare these effects with those of two other available OTC analgesics , aspirin and acetaminophen , we evaluated 25 elderly patients with mild thiazide-treated hypertension and mild renal insufficiency . Under double-blind conditions , patients were r and omly allocated to one of three treatment groups : ibuprofen 400 mg 3 times/day , aspirin 650 mg 3 times/day , or acetaminophen 650 mg 3 times/day . Blood pressure and indexes of renal function ( blood urea nitrogen , creatinine clearance , serum electrolytes ) were measured over 7 days in a clinical research center . None of the treatments had a clinical ly significant effect on blood pressure . Renal function indexes also remained unchanged during all three treatments . We conclude that elderly patients with mild thiazide-treated hypertension and mild renal insufficiency seem not to be at risk of developing additional renal compromise or of having their hypertension control diminished by treatment with these OTC analgesics for 7 days",
"OBJECTIVE To determine whether a regimen of methotrexate , cyclosporin A , and corticosteroids introduced at onset in poor-prognosis rheumatoid arthritis ( RA ) can produce a significant improvement in outcome compared with st and ard monotherapy with sulfasalazine ( SSZ ) . METHODS Eighty-two consecutive patients presenting with new , untreated RA of less than 12 months ' duration who fulfilled criteria for poor long-term outcome were r and omized to receive either combination therapy ( n = 40 ) or SSZ alone ( n = 42 ) . The primary outcome measures were remission and American College of Rheumatology ( ACR ) criteria for 20 % improvement at 48 weeks . RESULTS After 48 weeks , the numbers of patients who met the ACR criteria for 20 % improvement were not significantly different between the two groups ( combination 58 % versus SSZ 45 % ) , and similar numbers of patients had persisting clinical remission ( approximately 10 % both groups ) . During the first 3 months , there were significantly greater reductions in parameters of disease activity in the combination group . By 24 weeks , the swollen and tender joint counts , C-reactive protein levels , and erythrocyte sedimentation rates had fallen significantly in both groups , with a greater improvement in the swollen and tender joint count in the combination group . At 48 weeks , the radiographic damage score had increased by a median of 1 ( range 0 - 42.5 ) in the combination group and 1.25 ( range 0 - 72.5 ) in the SSZ group ( P = 0.28 ; although there were significant differences in the scores for the right h and ) . There were significantly fewer withdrawals due to lack of efficacy in the combination group than in the SSZ group ( 1 of 40 versus 10 of 42 ; P = 0.007 ) . In the combination group , dose reduction was needed in 22.5 % because of hypertension and in 22.5 % because of elevated creatinine levels . Over 48 weeks , serum creatinine increased in both groups , but particularly in the combination arm . CONCLUSION In poor-prognosis RA patients , \" aggressive \" combination therapy led to more rapid disease suppression but did not result in significantly better ACR response or remission rates . This suggests that in poor-prognosis disease , an approach based on identifying patients with poor treatment responses before extra therapy is added ( \" step-up \" approach ) may be more appropriate than the use of combination therapy in all patients from the outset",
"We performed a subgroup analysis of the first European Stroke Prevention Study including 1,306 patients recruited in a single center , Kuopio , Finl and , to investigate whether or not antiplatelet therapy is effective in the secondary prevention of stroke in hypertensive patients with transient ischemic attack ( TIA ) or stroke . The patients were treated with aspirin , 990 mg/day , plus dipyridamole , 225 mg/day , or placebo for 2 years . The patients with high systolic blood pressure ( > or = 140 mm Hg ; n = 1.105 ) or high diastolic blood pressure ( > or = 85 mm Hg ; n = 1,120 ) at entry , were classified into subgroups by blood pressure level . The effect of treatment was statistically significant in all subgroups with high systolic ( end-point reduction , 55.2 - 68.2 % ) and diastolic blood pressure ( end-point reduction , 47.3 - 82.1 % ) . Risk reduction was , however , greatest in patients with the highest diastolic blood pressure . One possible explanation is that platelets are more activated in these patients , and this can be effectively prevented by antiplatelet therapy . Further studies are needed to confirm this hypothesis",
"Objective : To evaluate the influence of non-steroidal anti-inflammatory drugs ( NSAIDs ; aspirin and indomethacin ) on the renal and antihypertensive effects of enalapril and nifedipine gastrointestinal therapeutic system ( GITS ) in patients with essential hypertension . Design and methods : In a crossover study , 18 patients on an unrestricted-salt diet were r and omly assigned to receive either enalapril ( 20 - 40 mg/day ) or nifedipine-GITS ( 30 - 60mg/day ) for 4 - 8 weeks , followed by aspirin ( 100 mg/day for 2 weeks ) and then indomethacin ( 75 mg/day for 1 week ) . Blood pressure was measured by 24 h ambulatory monitoring . Results : Enalapril and nifedipine-GITS significantly reduced blood pressure compared with placebo . Aspirin did not alter the antihypertensive effect of either drug . Indomethacin attenuated ( by 45 % ) the antihypertensive effect of enalapril throughout the 24 h period of evaluation , but did not interfere with the effect of nifedipine . Furthermore , indomethacin significantly reduced the fractional excretion of sodium and plasma levels of prostagl and ins in a similar way when added to either the enalapril or the nifedipine regimen . Conclusions : Vasodilatory prostagl and ins are probably involved in the antihypertensive effects of enalapril but not of nifedipine , and this interaction seems to be independent of any indomethacin-induced decrease in renal sodium excretion . Nifedipine may be an appropriate drug to treat hypertensive patients requiring concomitant therapy with NSAID",
"The effects of dihydropyridine calcium antagonists on blood pressure and platelets , and the effects of aspirin on the circadian antihypertensive efficacy of dihydropyridines and on the 24-h platelet-activity profile , were the focus of a double-blind study . Patients with essential hypertension were treated for 8 weeks with either isradipine focus of double-blind study . Patients with essential hypertension were treated for 8 weeks with either isradipine ( 2.5 mg/day ) or nitrendipine ( 10 mg/day ) . Aspirin ( 100 mg/day ) was added to both treatment groups for a further 8 weeks . Measurements were taken after 4 weeks of placebo , after 8 weeks of dihydropyridine treatment , and after 8 weeks of treatment combined with aspirin . Plasma levels of beta-thromboglobulin ( beta-TG ) and platelet aggregation induced by serotonin were measured six times during 24 h. Both dihydropyridines significantly lowered systolic and diastolic blood pressure . The addition of aspirin to dihydropyridine treatment had no significant effects on systolic or diastolic blood pressure . Dihydropyridine treatment lowered the increased 24-h plasma beta-TG profile and inhibited platelet aggregability . Aspirin added to nitrendipine led to a further significant decrease in beta-TG levels whereas its addition to isradipine was accompanied by a partial increase in plasma beta-TG . It is concluded that increases in platelet activity in hypertensive patients can be prevented with either isradipine alone or nitrendipine plus aspirin . Aspirin in a daily dose of 100 mg does not affect the antihypertensive efficacy of calcium antagonists",
"BACKGROUND Nonsteroidal antiinflammatory drugs ( NSAIDs ) may alter blood pressure through their inhibitory effects on prostagl and in bio synthesis . Such potential hypertensive effects of NSAIDs have not been adequately examined in the elderly , who are the largest group of NSAID users . METHODS We performed a r and omized , double-blind , two-period crossover trial of ibuprofen ( 1800 mg per day ) vs placebo treatment in patients older than 60 years of age with hypertension controlled with hydrochlorothiazide . While continuing their usual thiazide dosage , subjects were r and omized to a 4-week treatment period ( ibuprofen or placebo ) followed by a 2-week placebo wash-out period and a second 4-week treatment period with the alternative therapy . Supine and st and ing systolic and diastolic blood pressures were measured weekly . RESULTS Of 25 r and omized subjects , 22 completed the study protocol ( mean age = 73 + /- 6.7 years ) . Supine systolic blood pressure and st and ing systolic blood pressure were increased significantly with ibuprofen treatment , compared with placebo . Mean supine systolic blood pressures were 143.8 + /- 21.0 and 139.6 + /- 15.9 mmHg on ibuprofen and placebo , respectively ( p = .004 ) . Mean st and ing systolic blood pressures were 148.1 + /- 19.9 and 143.4 + /- 17.9 mmHg on ibuprofen and placebo , respectively ( p = .002 ) . CONCLUSION We conclude that 1800 mg per day of ibuprofen does induce a significant increase in systolic blood pressure in older hypertensive patients treated with hydrochlorothiazide . NSAID therapy may negatively impact the control of hypertension in elderly patients",
"The ability of angiotensin converting enzyme ( ACE ) inhibitors to lower blood pressure may in part be due to the formation of vasodilatory prostagl and ins . Inhibition of prostagl and in synthesis with aspirin may therefore theoretically attenuate the antihypertensive effect of ACE inhibitors . This trial studied the interaction between aspirin ( ASA ) and enalapril , an ACE inhibitor , and ASA and losartan , an angiotensin subtype 1 receptor antagonist . Seventeen essential hypertensive patients were studied , maintained on a stable dose of either enalapril ( n = 7 ) or losartan ( n = 10 ) monotherapy for > or = 12 weeks before and throughout the study . Each patient received a 2-week course of placebo , 81 mg/day ASA , and 325 mg/day ASA , each treatment separated by a 2-week washout period . Blood pressure ( BP ) and serum thromboxane B2 ( TXB2 ) sample s were obtained at the end of each treatment period . Placebo was compared with each dose of ASA for each group . In both the enalapril and losartan groups , mean , systolic , and diastolic BP were unchanged with the addition of ASA . Concentrations of TXB2 were suppressed to ASA . This study demonstrates that 81 to 325 mg/day ASA exerts no significant effect on BP in essential hypertensives taking enalapril or losartan",
"BACKGROUND After angioplasty , major complications and ischemic events occur more frequently in diabetic than nondiabetic patients . To determine whether treatment with abciximab is effective in reducing these events in diabetics , we analyzed characteristics and outcomes of diabetic patients enrolled in a large multicenter study ( EPILOG ) . METHODS AND RESULTS Of 2792 patients enrolled , 638 ( 23 % ) were diabetic . Diabetic patients were older , shorter , and heavier ; more likely to be female and have three-vessel disease , prior coronary artery bypass graft surgery , a history of hypertension , or a recent myocardial infa rct ion ; and less likely to be current smokers than their nondiabetic counterparts . During hospitalization , death , myocardial infa rct ion , or urgent revascularization occurred in 7.1 % of diabetics and 7.5 % of nondiabetics . By 6 months , the composite of death and myocardial infa rct ion had occurred in 8.8 % of diabetic patients and 7.4 % of nondiabetics , whereas death , myocardial infa rct ion , or revascularization had occurred in 27.2 % and 22.6 % , respectively . Abciximab treatment reduced death or myocardial infa rct ion among diabetic and nondiabetic patients ( hazard ratios , 0.28 [ 95 % confidence interval ( CI ) , 0.13 to 0.57 ] and 0.47 [ 95 % CI , 0.33 to 0.70 ] at 30 days for diabetics and nondiabetics , respectively , and 0.36 [ 95 % CI , 0.21 to 0.61 ] and 0.60 [ 95 % CI , 0.44 to 0.82 ] at 6 months for diabetics and nondiabetics , respectively ) . Abciximab reduced target vessel revascularization among nondiabetic patients ( hazard ratio , 0.78 [ 95 % CI , 0.63 to 0.96 ] ) but not among diabetics ( hazard ratio , 1.4 [ 95 % CI , 0.94 to 2.08 ] ) . When st and ard- and low-dose heparin adjuncts were compared , diabetics receiving abciximab with st and ard-dose heparin had marginally greater reductions in the composite of death and myocardial infa rct ion and in target vessel revascularization than diabetics assigned to abciximab with low-dose heparin . CONCLUSIONS Abciximab treatment in diabetic patients led to a reduction in the composite of death and myocardial infa rct ion , which was at least as great as that seen in nondiabetic patients . However , target vessel revascularization was reduced in nondiabetic but not diabetic patients . This effect may be associated in part with lower doses of heparin . These differences may be related to differences in the platelet and coagulation systems between diabetics and nondiabetics , the greater extent of coronary artery disease in diabetics , or patient selection and management factors",
"240 patients were admitted to a double-blind study to determine the effect of long-term treatment with platelet-function inhibiting agents on occlusive arterial disease in the lower extremities . Patients were r and omised into 1 of 3 treatment groups : aspirin 330 mg ; dipyridamole 75 mg and aspirin 330 mg ; or matching placebo 3 times daily . The duration of treatment was 2 years . Arteriography was carried out at the beginning of the study and 2 years later or before if deterioration was observed . 199 patients completed the study according to the trial protocol . The serial arteriograms were assessed in pairs qualitatively , by means of simple comparative viewing , and semiquantitatively with Bollinger 's score system . Progression of the disease was most pronounced in the placebo-treated group , less so in the aspirin-treated group , and least of all in the dipyridamole- and -aspirin group . Patients who smoke and those with hypertension may benefit most from treatment with the 2 preparations under investigation",
"A six year r and omised trial was conducted among 5139 apparently healthy male doctors to see whether 500 mg aspirin daily would reduce the incidence of and mortality from stroke , myocardial infa rct ion , or other vascular conditions . Though total mortality was 10 % lower in the treated than control group , this difference was not statistically significant and chiefly involved diseases other than stroke or myocardial infa rct ion . Likewise , there was no significant difference in the incidence of non-fatal myocardial infa rct ion or stroke — indeed , disabling strokes were somewhat commoner among those allocated aspirin . The lower confidence limit for the effect of aspirin on non-fatal stroke or myocardial infa rct ion , however , was a substantial 25 % reduction . Migraine and certain types of musculoskeletal pain were reported significantly less often in the treated than control group , but as the control group was not given a placebo the relevance of these findings was difficult to assess . There was no apparent reduction in the incidence of cataract in the treated group . The lack of any apparent reduction in disabling stroke or vascular death contrasts with the established value of antiplatelet treatment after occlusive vascular disease",
"OBJECTIVE A secondary subgroup analysis of the European Stroke Prevention Study of the effect of antiplatelet medication on the risk of myocardial infa rct ion . DESIGN AND SETTING A r and omized , double-blind placebo-controlled study with two parallel treatment groups ( dipyridamole plus aspirin and placebo ) . Sixteen centers from six countries participated in the study . PATIENTS A total of 2500 patients who had had one or more transient ischemic attacks or cerebral infa rct ions participated . INTERVENTION Combination therapy with dipyridamole ( 75 mg three times a day ) and aspirin ( 330 mg three times a day ) was compared with placebo during 24 months ' follow-up . OUTCOME MEASURES Prevention of fatal and nonfatal myocardial infa rct ion . RESULTS A total of 105 myocardial infa rct ions occurred in the intention-to-treat analysis and 76 occurred in the explanatory analysis . The overall risk reduction of myocardial infa rct ion with the study drugs was approximately 40 % in both statistical analyses , but the result was statistically significant only in the intention-to-treat analysis . Therapeutic efficacy was better among male patients , patients younger than 65 years , and patients with hypertension . CONCLUSION Combination therapy with dipyridamole and aspirin reduces not only the risk of cerebrovascular ischemic events but also the risk of myocardial infa rct ion",
"Abstract Objective : To determine which groups of patients may derive particular benefit or experience harm from the use of low dose aspirin for the primary prevention of coronary heart disease . Design : R and omised controlled trial . Setting : 108 group practice s in the Medical Research Council 's general practice research framework who were taking part in the thrombosis prevention trial . Participants : 5499 men aged between 45 and 69 years at entry who were at increased risk of coronary heart disease . Main outcome measures : Myocardial infa rct ion , coronary death , and stroke . Results : Aspirin reduced coronary events by 20 % . This benefit , mainly for non-fatal events , was significantly greater the lower the systolic blood pressure at entry ( interaction P=0.0015 ) , the relative risk at pressures 130 mm Hg being 0.55 compared with 0.94 at pressures > 145 mm Hg . Aspirin also reduced strokes at low but not high pressures , the relative risks being 0.41 and 1.42 ( P=0.006 ) respectively . The relative risk of all major cardiovascular events — that is , the sum of coronary heart disease and stroke — was 0.59 at pressures 145 mm Hg ( P=0.0001 ) . Conclusion : Even with the limitations of subgroup analyses the evidence suggests that the benefit of low dose aspirin in primary prevention may occur mainly in those with lower systolic blood pressures , although it is not clear even in these men that the benefit outweighs the potential hazards . Men with higher pressures may be exposed to the risks of bleeding while deriving no benefit through reductions in coronary heart disease and stroke",
"Nonsteroidal antiinflammatory drugs ( NSAIDs ) are known to attenuate the antihypertensive effects of a variety of antihypertensive agents including diuretics , beta-blockers , and vasodilators . Because of their unique mechanisms of actions , calcium channel blockers may not be subject to this interaction . This multicenter , double-blind , r and omized , placebo-controlled study was design ed to assess the effect of NSAID therapy on blood pressure control in stable hypertensive patients treated with a calcium channel blocker . One hundred patients with stable blood pressure control on 30 mg nicardipine three times a day were treated with 375 mg naproxen twice a day or placebo for 4 weeks . The mean diastolic blood pressures and estimated mean arterial pressures in both groups changed Body weight in the placebo-treated patients did not change significantly whereas body weight in the naproxen-treated patients increased significantly , from 90.3 + /- 3.2 kg to 91.0 + /- 3.2 kg ( mean = 0.7 , P = .0003 ) . At 4 weeks there was a mean loss of 0.1 kg in the placebo group and a mean gain of 0.4 kg in the naproxen group compared to baseline weights , neither of which was statistically significant ( P = .60 and P = .071 , respectively ) . These results indicate that despite a significant increase in body weight , the antihypertensive action of the calcium channel blocker nicardipine is not significantly affected by cotreatment with naproxen",
"Objective To test the hypothesis that an imbalance in intrarenal prostagl and ins plays a role in cyclosporin-induced nephrotoxicity . Methods and results Indomethacin was given in combination with cyclosporin to healthy volunteers . Cyclosporin alone ( 10mg/kg twice a day ) for 4 days had no effect on effective renal plasma flow ( ERPF ) and glomerular filtration rate but 4 days of therapy with cyclosporin ( 10mg/kg twice a day ) and indomethacin ( 50 mg twice a day ) in combination result ed in a 37 % fall in glomerular filtration rate and a 32 % fall in ERPF . This suggests that autoregulatory mechanisms , possibly involving renal prostagl and ins , may participate in counteracting the tendency for cyclosporin-induced renal vasoconstriction in humans . Cyclosporin increased systemic blood pressure acutely , and this was not influenced by indomethacin even though indomethacin on its own caused sodium retention . This suggests that , in contrast to the renal vasculature , the systemic vascular response to cyclosporin is neither augmented nor buffered by prostagl and ins . Conclusion The reduction in intrarenal prostagl and ins clearly played a key role in the development of cyclosporin-induced renal vasoconstriction , but we could not demonstrate a role for prostagl and ins or for sodium retention in the initiation of cyclosporin-induced hypertension",
"Sixteen hypertensive male out- patients ( 33 - 54 y ) , whose blood pressure ( BP ) had been normalized ( diastolic BP atenolol ( CAS 29122 - 68 - 7 ) , participated in this double-blind , placebo-controlled , parallel group study , which investigated the possible influence of the non-steroidal anti-inflammatory drug tenoxicam ( CAS 59804 - 37 - 4 ) on the control of BP by atenolol . After a run-in of 10 days , to assess the stability of BP control by atenolol , and to determine baseline parameters , 8 patients in group A received 20 mg tenoxicam ( 2 x 20 mg on days 1 and 2 ) , and 8 patients in group B received placebo , daily over 15 days ( days 0 - 14 ) , concomitantly with their atenolol regimen . BP was measured under st and ardized conditions on several days . Heart rate ( EHR ) after 5 min of exercise by bicycle ergometry ( constant 75W ) , and parameters of renal function were assessed before ( baseline ) and during concomitant dosing of atenolol and tenoxicam . On day 14 the mean changes ( delta A , delta B ) from baseline of pre-dose BP ( mmHg ) and EHR ( beats/min ) in groups A and B , and the one-sided 95 % confidence regions ( R ) for delta A , respectively , were ( delta A , delta B , R ) : 4.4 , 1.6 , sitting systolic BP , 2.8 , -0.3 , sitting diastolic BP , -0.3 , -0.6 , st and ing systolic BP , -0.6 , -1.9 , st and ing diastolic BP , 0.4 , -7.5 , < 0.4 for EHR at pre-dose , 3.1 , 0.6 , < 7.8 for EHR at 3.5 h post-dose . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The effects of aspirin ( 1950 mg/day orally ) or indomethacin ( 75 mg/day orally ) on blood pressure were investigated in normotensive volunteers and hypertensive patients receiving antihypertensive medication . Aspirin ( 1950 mg/day ) did not change blood pressure or body weight in normotensive or treated hypertensive subjects . No significant change in plasma renin concentration was seen with aspirin ( 1950 mg/day ) in treated hypertensive subjects . Indomethacin ( 75 mg/day ) significantly increased blood pressure in normotensive subjects and treated hypertensive subjects . Body weight increased significantly in the treated hypertensive subjects but not normotensive subjects . In treated hypertensive subjects indomethacin ( 75 mg/day ) did not change plasma volume , but significantly decreased plasma renin concentration",
"This study tested the hypothesis that treatment with a nonsteroidal anti-inflammatory drug will not alter the hypotensive effect of a dihydropyridine calcium channel antagonist . Fifteen essential hypertensives ( ages 58 - 80 years ) had a supine diastolic blood pressure ( DBP ) nitrendipine 5 - 20 mg twice daily . They entered a double-blind r and omised crossover study in which the addition of indomethacin 25 mg three times daily was compared with placebo in treatment phases each of 4 weeks duration . Subjects were seen weekly and measurements in the last 2 weeks of each phase were compared . Supine blood pressure ( mean + /- SE ) was higher in the indomethacin phase ( 158 + /- 4/80 + /- 2 ) than in the placebo phase ( 154 + /- 4/76 + /- 3 ) ( p supine diastolic blood pressure with indomethacin was > 5 mmHg . Plasma urea was also increased in the indomethacin phase : 7.6 + /- 0.6 mmol/l compared with placebo : 6.3 + /- 0.5 mmol/l ( p indomethacin impairs the blood pressure lowering effect of the dihydropyridine calcium channel antagonist nitrendipine . This increase in blood pressure with indomethacin in subjects treated with nitrendipine may represent either an independent pressor effect of indomethacin or a reduced vasodilator prostanoid contribution to the hypotensive effect of nitrendipine . This blood pressure increase may be sufficient to interfere significantly with clinical blood pressure control in some subjects",
"BACKGROUND Despite the use of antiplatelet agents , usually aspirin , in patients who have had an ischemic stroke , there is still a substantial rate of recurrence . Therefore , we investigated whether warfarin , which is effective and superior to aspirin in the prevention of cardiogenic embolism , would also prove superior in the prevention of recurrent ischemic stroke in patients with a prior noncardioembolic ischemic stroke . METHODS In a multicenter , double-blind , r and omized trial , we compared the effect of warfarin ( at a dose adjusted to produce an international normalized ratio of 1.4 to 2.8 ) and that of aspirin ( 325 mg per day ) on the combined primary end point of recurrent ischemic stroke or death from any cause within two years . RESULTS The two r and omized study groups were similar with respect to base-line risk factors . In the intention-to-treat analysis , no significant differences were found between the treatment groups in any of the outcomes measured . The primary end point of death or recurrent ischemic stroke was reached by 196 of 1103 patients assigned to warfarin ( 17.8 percent ) and 176 of 1103 assigned to aspirin ( 16.0 percent ; P=0.25 ; hazard ratio comparing warfarin with aspirin , 1.13 ; 95 percent confidence interval , 0.92 to 1.38 ) . The rates of major hemorrhage were low ( 2.22 per 100 patient-years in the warfarin group and 1.49 per 100 patient-years in the aspirin group ) . Also , there were no significant treatment-related differences in the frequency of or time to the primary end point or major hemorrhage according to the cause of the initial stroke ( 1237 patients had had previous small-vessel or lacunar infa rcts , 576 had had cryptogenic infa rcts , and 259 had had infa rcts design ated as due to severe stenosis or occlusion of a large artery ) . CONCLUSIONS Over two years , we found no difference between aspirin and warfarin in the prevention of recurrent ischemic stroke or death or in the rate of major hemorrhage . Consequently , we regard both warfarin and aspirin as reasonable therapeutic alternatives",
"BACKGROUND The incidence of stroke in patients with acute coronary syndromes has not been clearly defined because few trials in this patient population have been large enough to provide stable estimates of stroke rates . METHODS AND RESULTS We studied the 10 948 patients with acute coronary syndromes without persistent ST-segment elevation who were r and omly assigned to placebo or the platelet glycoprotein IIb/IIIa receptor inhibitor eptifibatide in the Platelet Glycoprotein IIb/IIIa in Unstable Angina : Receptor Suppression Using Integrilin Therapy ( PURSUIT ) trial to determine stroke rates , stroke types , clinical outcomes in patients with stroke , and independent baseline clinical predictors for nonhemorrhagic stroke . Stroke occurred in 79 ( 0.7 % ) patients , with 66 ( 0.6 % ) nonhemorrhagic , 6 intracranial hemorrhages , 3 cerebral infa rct ions with hemorrhagic conversion , and 4 of uncertain cause . There were no differences in stroke rates between patients who received placebo and those assigned high-dose eptifibatide ( odds ratios and 95 % confidence intervals 0.82 [ 0.59 , 1.14 ] and 0.70 [ 0.49 , 0.99 ] , respectively ) . Of the 79 patients with stroke , 17 ( 22 % ) died within 30 days , and another 26 ( 32 % ) were disabled by hospital discharge or 30 days , whichever came first . Higher heart rate was the most important baseline clinical predictor of nonhemorrhagic stroke , followed by older age , prior anterior myocardial infa rct ion , prior stroke or transient ischemic attack , and diabetes mellitus . These factors were used to develop a simple scoring nomogram that can predict the risk of nonhemorrhagic stroke . CONCLUSIONS Stroke was an uncommon event in patients with acute coronary syndromes in the PURSUIT trial . These strokes are , however , associated with substantial morbidity and mortality rates . The majority of strokes were of nonhemorrhagic causes . Eptifibatide was not associated with an increase in intracranial hemorrhage , and no significant effect on nonhemorrhagic stroke was observed . We developed a useful nomogram for assigning baseline nonhemorrhagic stroke risk in this patient population",
"The safety and pharmacodynamic compatibility of clopidogrel with medications commonly used in patients with atherosclerosis , such as , a beta-adrenergic receptor antagonist ( atenolol ) and a calcium uptake inhibitor ( nifedipine ) were assessed . Atenolol and nifedipine interactions with clopidogrel were studied in patients with peripheral arterial obstructive disease taking a well-established regimen of nifedipine ( N group of 6 patients ) and in patients with coronary artery disease taking a well-established regimen of either atenolol ( A group of 8 patients ) or of atenolol and nifedipine ( AN group of 8 patients ) . The study was conducted as a double-blind , r and omized , crossover comparison of clopidogrel , 75 mg once daily , and placebo treatment for 7 days , with a 14-day washout between treatments . Pharmacodynamic interactions between atenolol and nifedipine , either alone or in combination , and clopidogrel were assessed primarily on the clinical control of angina or hypertension and , secondarily , by comparing the extent of inhibition of ADP ( 5 microM)-induced platelet aggregation achieved between the 3 groups . The mean number of anginal episodes per patient during the placebo week was 1.50 , 9.0 and 11.5 in the A , N and AN groups , respectively ; during the week of clopidogrel treatment , it was 1.39 , 7.3 and 9.0 , respectively , indicating no change in occurrence . Likewise , review of the use of nitrates ( long or short acting ) did not suggest any major change in usage during any period of the study . ECGs did not change between the three recording times ( at screening and at the end of each treatment period ) . Vital signs were also unchanged throughout . Percent inhibition of platelet aggregation on day 7 was 31 % in the N group , 39 % in the A group , 28 % in the AN group , and 33 % overall . In conclusion , the coadministration of clopidogrel did not interfere with the clinical control of hypertension or angina established with atenolol or nifedipine , or both . Clopidogrel retained its full antiplatelet effect , and there were no safety problems caused by the coadministration",
" Patients ( 303 ) who had had carotid territory transient ischemic attacks were r and omly assigned to aspirin or placebo treatments . Patients with amaurosis fugax responded as well to aspirin as those with hemisphere events . Patients with lesions of the appropriate carotid artery responded better to aspirin therapy than patients with no lesion or an occlusion . The aspirin effect was the same across all risk-factor groups . Smoking had no effect on clinical outcome",
"1 . The haemodynamic effects of calcium antagonists could depend at least in part on the activity of vasoactive prostanoids . 2 . We set out to study the effect of the cyclo-oxygenase inhibitor ibuprofen , 400 mg three times daily for 3 days , by a r and omised cross-over study vs placebo in 12 mild to moderate essential hypertensive patients who had been treated for 1 month with amlodipine . 3 . Blood pressure , heart rate and vascular resistances in the upper limb ( Doppler ultrasound ) were measured . Plasma renin activity and urinary aldosterone , as well as indices of renal function , were evaluated . Urinary 2,3-dinor-6-keto-PGF1 alpha and 2,3-dinor-TXB2 , as well as 6-keto-PGF1 alpha and TXB2 , were measured as indices of systemic and renal PGI2 and TXA2 synthesis . 4 . Amlodipine normalised blood pressure and reduced upper limb vascular resistances ; it did not affect urinary prostanoid excretion . Short-term combined administration of ibuprofen result ed in , by comparison with placebo , inhibition of systemic PGI2 ( -80.5 ng 24 h-1 , 95 % CI -99.2 , -61.4 ; P TXA2 ( -216.1 ng 24 h-1 , 95 % CI -276.5 , -155.8 ; P systolic ( + 7.8 mm Hg , 95 % CI + 3.1 , + 12.3 ; P diastolic ( + 3.9 mm Hg , 95 % CI + 1.2 , + 6.6 ; P blood pressure ; it had no significant effect on regional vascular resistances ( + 4.7 mm Hg ml-1 s , 95 % CI -5.6 , + 15.0 ) . Effects of ibuprofen on renal prostanoid synthesis were less marked , and there was no change in indices of renal function or hydro-electrolytic balance . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Objective Differences in renal synthesis between prostagl and ins I2 and E2 , and the relationships of the amounts synthesized to renin release were investigated in patients with essential hypertension . Methods Of 12 in patients , six had low to normal plasma renin activity and six had high renin activity . Before and 30 min after intravenous injection of aspirin D , L-lysine ( 18 mg/kg ) , abdominal aortic and renal venous plasma was sample d and assayed for renin activity , 6-keto-prostagl and in F1α ( as an index of prostagl and in I2 ) , and prostagl and in E2 . Results In patients with low to normal renin activity , mean ± SD plasma levels of 6-keto-prostagl and in F1α were lower in the right and left renal veins ( 3.6 ± 1.4 and 4.1 ± 1.5 pg/ml , respectively ) than in the aorta ( 5.5 ± 2.0 pg/ml ) , but in the other patients , the levels in these veins ( 7.0 ± 2.4 and 6.5 ± 1.5 pg/ml ) were higher than in the aorta ( 5.4 ± 0.9 pg/ml ) . Plasma prostagl and in E2 levels in both veins were higher than in the aorta in both groups and , at each site , the levels were similar in the two groups . Aspirin suppressed renin release in the patients with high renin activity . Conclusions In patients with essential hypertension with low to normal renin activity , either less prostagl and in I2 than prostagl and in E2 is produced in the kidney or else more is metabolized there , and in such patients with high renin activity , the renal synthesis of prostagl and in I2 , more than that of prostagl and in E2 , seems to be related to the increased renin release",
"BACKGROUND Repeat hospitalizations of patients with atherosclerosis represent a considerable burden on the health care system . We sought to determine whether clopidogrel compared with aspirin decreases the need for rehospitalization for ischemia and bleeding . METHODS AND RESULTS The Clopidogrel Versus Aspirin in Patients at Risk of Ischemic Events ( CAPRIE ) trial was a r and omized , blinded , multicenter , trial of 19,185 patients with atherosclerotic disease manifested as recent ischemic stroke or myocardial infa rct ion or symptomatic peripheral arterial disease . Without any double-counting of events , the number of rehospitalizations for ischemic events ( defined as angina , transient ischemic attack , or limb ischemia ) or bleeding events was determined for the entire cohort . There was a significant reduction in the total number of rehospitalizations for ischemic events or bleeding with clopidogrel use compared with aspirin ( 1502 vs 1673 ; P = .010 ) over an average of 1.6 years of treatment . This reduction in rehospitalization was consistent across individual outcomes of angina , transient ischemic attack , limb ischemia , and bleeding . Compared with aspirin , clopidogrel also result ed in a 7.9 % relative risk reduction in a combined end point of vascular death , stroke , myocardial infa rct ion , or rehospitalization for ischemic events or bleeding ( 15.1 % to 13.7 % at 1 year ; P = .011 ) . Adjusting for baseline prognostic variables , clopidogrel therapy was an independent predictor for reduction of vascular death , stroke , myocardial infa rct ion , or rehospitalization for ischemic events or bleeding ( P = .009 ) . CONCLUSIONS Treatment with clopidogrel results in a significant decrease in the need for rehospitalization for ischemic events or bleeding compared with aspirin . This meaningful end point tracks well with other , more traditional measures of outcome and has incremental value beyond such end points",
"Warfarin is an established treatment for prevention of ischaemic stroke in patients with atrial fibrillation , but the value of this agent relative to aspirin in unclear . In the first Stroke Prevention in Atrial Fibrillation ( SPAF-I ) study , direct comparison of warfarin with aspirin was limited by the small number of thromboembolic events . SPAF-II aims to address this issue and also to assess the differential effects of the two treatments according to age . We compared warfarin ( prothrombin time ratio 1.3 - 1.8 , international normalised ratio 2.0 - 4.5 ) with aspirin 325 mg daily for prevention of ischaemic stroke and systemic embolism ( primary events ) in two parallel r and omised trials involving 715 patients aged 75 years or less and 385 patients older than 75 ; we sought reductions in the absolute rate of primary events by warfarin compared with aspirin of 2 % per year and 4 % per year , respectively . In the younger patients , warfarin decreased the absolute rate of primary events by 0.7 % per year ( 95 % CI-0.4 to 1.7 ) . The primary event rate per year was 1.3 % with warfarin and 1.9 % with aspirin ( relative risk [ RR ] 0.67 , p = 0.24 ) . The absolute rate of primary events in low-risk younger patients ( without hypertension , recent heart failure , or previous thromboembolism ) on aspirin was 0.5 % per year ( 95 % CI 0.1 to 1.9 ) . Among older patients , warfarin decreased the absolute rate of primary events by 1.2 % per year ( 95 % CI-1.7 to 4.1 ) . The primary event rate per year was 3.6 % with warfarin and 4.8 % with aspirin ( RR 0.73 , p = 0.39 ) . In this older group , the rate of all stroke with residual deficit ( ischaemic or haemorrhagic ) was 4.3 % per year with aspirin and 4.6 % per year with warfarin ( RR 1.1 ) . Warfarin may be more effective than aspirin for prevention of ischaemic stroke in patients with atrial fibrillation , but the absolute reduction in stroke rate by warfarin is small . Younger patients without risk factors had a low rate of stroke when treated with aspirin . In older patients the rate of stroke ( ischaemic and haemorrhagic ) was substantial , irrespective of which agent was given . Patient age and the inherent risk of thromboembolism should be considered in the choice of antithrombotic prophylaxis for patients with atrial fibrillation ",
"Some of the antihypertensive effects of angiotensin-converting enzyme ( ACE ) inhibitors occur through nonangiotensin II-mediated mechanisms . One of these is through decreased kinin degradation , leading to enhanced production of vasodilator arachidonic acid metabolites . It was reasoned that if ACE inhibition also leads to an increase in the production of the potent vasoconstrictor thromboxane A2 , then maneuvers that selectively inhibit thromboxane production without reducing prostagl and ins ( PG ) E2 + PGI2 might enhance the antihypertensive effect of ACE inhibition . This double-blinded , r and omized , crossover study was therefore undertaken to determine : ( 1 ) if captopril increases platelet and /or renal thromboxane production ; and ( 2 ) if low-dose aspirin enhances the antihypertensive effect of captopril . Patients with mild essential hypertension and no other significant medical problems were studied . In a double-blinded , r and om order , patients took captopril alone ( 25 mg every 12 h ) for 2 wk and captopril plus aspirin ( 75 mg/day ) for another 2 wk . Active treatment periods were preceded by 2 wk of single-blind placebo . Fifteen patients with a mean age of 53 yr and an average mean arterial pressure ( MAP ) of 114 + /- 8 ( + /- SD ) mm Hg were studied . Serum thromboxane B2 was higher ( P captopril/placebo ( 600 + /- 46 ( + /- SE ) pg/mL ) than during the two washout periods combined ( 420 + /- 57 and 553 + /- 78 ) and was lowest ( P captopril/aspirin ( 302 + /- 36 ) . Captopril treatment significantly increased the urinary excretion of PGE2 ( P = 0.038 ) . Captopril/placebo significantly lowered MAP ( P captopril caused no additional lowering of MAP ( 105.2 + /- 2.8 mm Hg ) . It was concluded that treatment with captopril does increase platelet thromboxane production . However , lowering platelet thromboxane with low doses of aspirin may not enhance the antihypertensive effect of captopril",
"The effects of non-steroidal anti-inflammatory drugs ( NSAIDs ) on the blood pressure and renal function of essential hypertensive patients depend on the specific type of NSAID and antihypertensive drug administered . Twelve patients with essential hypertension , aged 35 to 59 years , stabilized ( blood pressure less than 140/90 mmHg ) with captopril , received ketoprofen ( 100 mg bid for 7 days ) or matching placebo in a r and omized double-blind cross-over fashion . A 3-week wash-out period was included between treatment periods . Blood pressure on the first and last days of the placebo treatment period ( 137 + /- 7 (SD)/80 + /- 8 and 139 + /- 11/81 + /- 9 mmHg ) was similar to respective values during ketoprofen therapy ( 136 + /- 10/79 + /- 7 and 143 + /- 10/81 + /- 9 mmHg ) . The mean differences in systolic and diastolic blood pressures , at the end of the treatment periods , between ketoprofen and placebo were 4 ( 95 % confidence intervals -5 , + 13 ) and 0 (-8 , + 8) mmHg , respectively . Ketoprofen had no effect on 24-h urinary sodium excretion ( 160 + /- 33 and 147 + /- 39 mmol/24 h for ketoprofen and placebo , respectively ) . Ketoprofen was without effect on glomerular filtration rate , renal plasma flow and filtration fraction . In conclusion , our data suggest that ketoprofen is a safe choice when short-term treatment with a NSAID is indicated in an essential hypertensive patient treated with a converting enzyme inhibitor such as captopril",
"The Physicians ' Health Study is a r and omized , double-blind , placebo-controlled trial design ed to determine whether low-dose aspirin ( 325 mg every other day ) decreases cardiovascular mortality and whether beta carotene reduces the incidence of cancer . The aspirin component was terminated earlier than scheduled , and the preliminary findings were published . We now present detailed analyses of the cardiovascular component for 22,071 participants , at an average follow-up time of 60.2 months . There was a 44 percent reduction in the risk of myocardial infa rct ion ( relative risk , 0.56 ; 95 percent confidence interval , 0.45 to 0.70 ; P less than 0.00001 ) in the aspirin group ( 254.8 per 100,000 per year as compared with 439.7 in the placebo group ) . A slightly increased risk of stroke among those taking aspirin was not statistically significant ; this trend was observed primarily in the subgroup with hemorrhagic stroke ( relative risk , 2.14 ; 95 percent confidence interval , 0.96 to 4.77 ; P = 0.06 ) . No reduction in mortality from all cardiovascular causes was associated with aspirin ( relative risk , 0.96 ; 95 percent confidence interval , 0.60 to 1.54 ) . Further analyses showed that the reduction in the risk of myocardial infa rct ion was apparent only among those who were 50 years of age and older . The benefit was present at all levels of cholesterol , but appeared greatest at low levels . The relative risk of ulcer in the aspirin group was 1.22 ( 169 in the aspirin group as compared with 138 in the placebo group ; 95 percent confidence interval , 0.98 to 1.53 ; P = 0.08 ) , and the relative risk of requiring a blood transfusion was 1.71 . This trial of aspirin for the primary prevention of cardiovascular disease demonstrates a conclusive reduction in the risk of myocardial infa rct ion , but the evidence concerning stroke and total cardiovascular deaths remains inconclusive because of the inadequate numbers of physicians with these end points",
"The use of cyclooxygenase inhibitors has been seen to reduce the efficacy of many antihypertensive drugs . However , cyclooxygenase inhibitors are normally non-selective because they affect both vascular tissue , where the endothelial prostanoids exert principally a vasodilatory action , and the kidneys , where they also play an important role in regulating hydroelectrolytic metabolism by redistribution of intraparenchymal flow . To evaluate the relative importance of vascular district in the hypertensive patient , we administered ibuprofen - a drug acting with only a minimal antagonist activity . A group of 20 male hypertensives were r and omly allocated , according to a single-blind protocol , to treatment with amlodipine ( A , 10 mg/day ) or lisinopril ( L , 20 mg/day ) . Blood pressure was significantly reduced after 30 days , with a mean difference of -21.75 mmHg for systolic blood pressure ( SBP ) ( 95 % confidence interval ( Cl ) : -27.46 to -16.04 ; P diastolic blood pressure ( DBP ) ( 95 % Cl : -17.13 to -11.17 ; P Brachial artery compliance showed a mean increase of 1.657 x 10(-7 ) dyn-1 cm(4 ) ( 95 % Cl : 1.188 to 2.126 ; P forearm resistances showed a mean decrease of -41.973 mmHg ml(-1)s ( 95 % Cl : -75.479 to -8.467 ; P = 0.017 ) . Changes in compliance were significantly related to those in SBP ( r= -0.546 ; P= 0.013 ) . The administration of ibuprofen ( 400 mg , three times a day for 3 days ) was accompanied by a slight but significant increase in SBP , but not in brachial artery compliance or forearm resistances . Only SBP was affected , showing a mean increase of 4.25 mmHg ( 95 % Cl : 1.26 to 7.24 ; P = 0.008 ) . There was also reduced urinary excretion of PGI(2 ) and TXA(2 ) metabolites . The mean change in 6-keto-PGF(1 alpha ) and 2,3-dinor-6-keto-PGF(1 alpha ) was 45.71 ng per g urinary creatinine ( uCr ) ( 95 % Cl : -0.16 to-91.25 ; P= 0.049 ) and -73.17 ng ( g uCr)(-1 ) ( 95 % Cl : -38.81 to -107.53 ; P mean decrease in TXA(2 ) catabolites was highly significant : -39.2 ng ( g uCr)(-1 ) ( 95 % Cl : -18.17 to-60.22 ; P changes in blood pressure and those in urinary 2,3-dinor-6-keto-PGF(1alpha ) excretion , irrespective of antihypertensive regimen . This suggests that , in the hypertensive patient treated with NSAIDs , inhibition of vascular prostanoid synthesis may play an important role in countering the efficacy of an important vascular tone regulatory mechanism",
"Aspirin at low doses is used as an inhibitor of platelet aggregation and is frequently administered to essential hypertensive patients with arterial thrombotic complications . However , it is unknown whether aspirin can modify blood pressure values either in treated or untreated hypertensive patients , as described for other non steroidal anti-inflammatory drugs . Thus 30 patients . 10 with mild uncomplicated and untreated essential hypertension , 10 with essential hypertension under chronic treatment with captopril , 50 mg bid , and 10 with essential hypertension under chronic treatment with atenolol , 100 mg oid , received aspirin , 100 mg oid , and the corresponding placebo for one month , according to a double blind r and omized cross-over design . At the end of each treatment , blood pressure , heart rate , generated serum thromboxane B2 and urinary excretion of thromboxane B2 and 6 keto prostagl and in F1 alpha and plasma renin activity were measured . Both in treated and untreated essential hypertensive patients , aspirin administration did not affect blood pressure , heart rate and urinary 6 keto prostagl and in F1 alpha , while it significantly reduced serum and urinary excretion of thromboxane B2 and plasma renin activity . In conclusion , while the present data confirm that low doses of aspirin selectively inhibit thromboxane B2 synthesis , they indicate that aspirin at 100 mg oid can be administered to treated and untreated essential hypertensive patients without any harmful effect on blood pressure values",
"Background Arthritis and hypertension are common comorbid conditions affecting elderly adults . Use of nonsteroidal anti-inflammatory drugs in patients treated with antihypertensive medication can lead to destabilization of blood pressure control and other cardiorenal events . The potential for similar interactions with cyclooxygenase-2–specific inhibitors has not been fully explored . The authors evaluated the cardiorenal safety of two new cyclooxygenase-2–specific inhibitors , celecoxib and rofecoxib . Methods This study was a 6-week , r and omized , parallel-group , double-blind trial in patients with osteoarthritis who were ≥65 years of age and were taking antihypertensive agents . Patients received once-daily celecoxib 200 mg or rofecoxib 25 mg . The primary endpoints were the development of edema , changes in systolic blood pressure , and changes in diastolic blood pressure as measured at any time point in the study . Measurements occurred at baseline and after 1 , 2 , and 6 weeks of treatment . Findings Eight hundred ten patients received study medication ( celecoxib , n = 411 ; rofecoxib , n = 399 ) . Nearly twice as many rofecoxib-compared with celecoxib-treated patients experienced edema ( 9.5 % vs. 4.9 % , P = 0.014 ) . Systolic blood pressure increased significantly in 17 % of rofecoxib-compared with 11 % of celecoxib-treated patients ( P = 0.032 ) at any study time point . Diastolic blood pressure increased in 2.3 % of rofecoxib-compared with 1.5 % of celecoxib-treated patients ( P = 0.44 ) . At week 6 , the change from baseline in mean systolic blood pressure was + 2.6 mmHg for rofecoxib compared with −0.5 mmHg for celecoxib ( P = 0.007 ) . Conclusions Patients taking antihypertensive therapy and receiving cyclooxygenase-2–specific inhibitors should be monitored for the development of cardiorenal events . Patients receiving celecoxib experienced less edema and less destabilization of blood pressure control compared with those receiving rofecoxib ",
"Thirty-seven patients affected by polycythaemia rubra vera ( PRV ) and with at least one additional thrombotic risk factor ( overt vascular disease , diabetes mellitus , treated hypertension , smoking habit , plasma hyperviscosity , hyperfibrinogenemia ) were enrolled in a double-blind r and omized placebo-controlled study , and 18 were given ticlopidine 250 mg , b.i.d . , for 60 days . All the patients had previously been su bmi tted to cytoreduction , and PRV was under control in all cases at the start of the study . During the study , the haematological parameters were controlled every 15 days , and venesection was performed if haematocrit was greater than 46 % . Whole blood viscosity , at low and high shear rates , plasma viscosity , and fibrinogen were measured on days 0 and 60 . In the ticlopidine group , we recorded a significant 13.14 % reduction of the mean fibrinogen level after treatment ( 390 + /- 63 vs. 449 + /- 97 mg/dl , p less than 0.01 ) . All the other haemorheological parameters were not significantly modified by ticlopidine treatment , nor were there significant modifications recorded in the placebo group . Our study shows that ticlopidine may reduce a probable thrombotic risk factor ( hyperfibrinogenemia ) in PRV patients",
"A comparative study of the prevention of recurrences of cerebral transient ischemic attacks during a 6-month observation period was conducted in 73 patients treated with a combination of acetylsalicylic acid and dipyridamole ( ASAD , 1,050 mg + 150 mg/day ) and in 65 patients treated with pentoxifylline ( PTX 1,200 mg/day , Trental 400 t.d.s . ) . The patients were r and omly assigned to the treatments . Risk factor analysis showed high prevalence of arterial hypertension , hyperlipidemia and smoking in these patients . The two groups were matched in terms of age , sex , blood pressure and site of TIA origin ( carotid 63 % in the ASAD , 65 % in the PTX group ) . 23 ASAD patients and 9 PTX patients suffered a recurrence . There were 4 nonfatal stroke events with ASAD and 2 with PTX . 80 recurrent TIAs were recorded in 19 ASAD patients compared with 19 such episodes in 9 PTX subjects . The morbidity rates ( life table analysis ) were significantly lower ( p less than 0.05 ) in the PTX group . The results of the study point to a preventive effect of PTX in terms of the reduction in TIA recurrences"
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& NA ; Alpha‐Lipoic Acid ( ALA ) is a natural antioxidant compound which is naturally found in plant sources . New evidence revealed that ALA can reduce inflammation . Our objective in this meta‐ analysis was to conduct a systematic review and meta‐ analysis on r and omized controlled trials to indicate ALA effects on serum inflammatory mediators concentration such as tumor necrosis factor‐alpha ( TNF‐&agr ; ) , c‐reactive protein ( CRP ) , and interleukin‐6 ( IL‐6 ) . In order to find relevant articles we performed a systematic research up to June 2018 using EMBASE , ISI web of science , Scopus , PubMed , and Google scholar . The overall treatment effect for each inflammatory marker was calculated as weighted mean differences ( WMD ) and corresponding 95 % of confidence interval ( CI ) between changes in intervention and control groups . Changes for each parameter were calculated by subtracting baseline values from the final mean values . The I2 statistic was used to examine between‐ study heterogeneity . When heterogeneity was > 25 % , r and om effect model was run to estimate pooled effect size . There had been nineteen articles in our meta‐ analysis and twenty‐one articles in systematic review . Our meta‐ analysis results indicated that ALA significantly decreased serum CRP levels ( WMD= −0.29 , 95 % CI : −0.46 , −0.12 ; I2 = 97.6 % , P ( WMD= −3.02 , 95 % CI : −4.03 , −2.01 ; I2 = 99.7 % , P levels ( WMD= −1.71 , 95 % CI : −2.30 , −1.13 ; I2 = 99.0 % , P decreasing effect of ALA on inflammatory mediators especially in high dose . More r and omized clinical trials ( RCTs ) are necessary with different intervention duration and on women and men separately
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"The aim of this study was to evaluate the efficacy of low-level laser therapy ( LLLT ) and alpha-lipoic acid ( ALA ) in the treatment of burning mouth syndrome ( BMS ) and secondary oral burning ( SOB ) by unstimulated sialometry , symptom assessment , and measurement of salivary TNF-α levels . Forty-four patients were r and omized into four treatment groups : BMS/laser ( n = 10 ) , BMS/ALA ( n = 5 ) , SOB/laser ( n = 15 ) , and SOB/ALA ( n = 14 ) . The control group consisted of eight healthy female subjects . Unstimulated salivary flow was measured before and after treatment , and the collected saliva was stored at − 20 ° C for the analysis of TNF-α . Symptoms were evaluated before and after treatment using a pain visual analog scale . Most patients were women ( 81.8 % ) during menopause ( 72.2 % ) . LLLT and ALA were efficient in increasing salivary flow only in BMS but provided symptom relief in both conditions . TNF-α levels did not differ between patients with BMS and SOB or between those patients and the control group . No differences were observed in posttreatment TNF-α levels in either condition . The results of this study suggest that LLLT and ALA are efficient therapies in reducing burning mouth symptoms , with LLLT being more efficient than ALA",
"Background : A limited amount of data exists regarding the effect of lipoic acid ( LA ) , an oral antioxidant supplement , on cytokine profiles among multiple sclerosis ( MS ) patients . Objective : We aim ed to assess the effect of daily consumption of LA on the cytokine profiles in MS patients . Methods : In this double-blind , placebo-controlled , r and omized clinical trial , 52 relapsing-remitting MS patients with an age range of 18 - 50 years were recruited into 2 groups : LA consumption ( 1,200 mg/day ) or placebo . Patients followed their prescribed supplements for 12 weeks . Fasting blood sample s for cytokine profile measurement were collected at baseline and after the intervention . Anthropometric parameters were measured based on the st and ard guidelines . Results : INF-γ , ICAM-1 , TGF-β and IL-4 were significantly reduced in the LA group compared to the placebo group [ ( INF-γ : 0.82 ± 0.2 vs. 0.2 ± 0.2 pg/ml , p changes in TNF-α , IL-6 , EDSS and MMP-9 were found between the LA and placebo groups ( p = 0.6 , p = 0.8 , p = 0.09 and p = 0.8 , respectively ) . Conclusion : The results suggested that consumption of 1,200 mg LA per day beneficially affects several inflammatory cytokines including INF-γ , ICAM-1 TGF-β and IL-4 . Further investigations are needed to verify the beneficial role of LA on other cytokine profiles among MS patients",
"OBJECTIVE To examine whether 3 months of lipoic acid ( LA ) supplementation improved walking tolerance and delayed claudication pain onset in peripheral arterial disease ( PAD ) . DESIGN R and omized , double-blind , controlled study . SETTING General Clinical Research Center . SUBJECTS Twenty-eight ( 28 ) participants ( 15 men , 13 women ) with PAD ( ankle brachial index range 0.9 - 0.4 , mean age 73.2 + /- 1.6 years ) . INTERVENTION LA ( 600 mg/day ) or placebo for 3 months . OUTCOME MEASURES Walking tolerance was assessed by 6-minute walk test distance , 4-meter walk time , initial claudication pain time ( ICT ) and distance ( ICD ) , and peak claudication pain . Serum was assessed for inflammation ( C-reactive protein [ CRP ] ) and oxidative stress ( lipid hydroperoxides ) as potential mechanisms for changes in walking tolerance . RESULTS ICT increased 34.4 % and 15 % , ICD was reduced by 40.5 % and 18 % , and peak claudication pain ratings were reduced by 93 % and 7 % in LA and placebo groups , respectively . Although the improvements in peak pain and ICT achieved significance within the LA group ( both p0.05 ) . Oxidative stress and CRP measures were not different between groups by month 3 ( p>0.05 ) . There were no serious side-effects associated with the LA . CONCLUSIONS LA may confer pain relief during exercise . However , longer and larger trials are warranted to determine long-term effects of LA alone or combined with other interventions on PAD symptoms",
"Several studies showed that impairment of endothelium-dependent arterial dilation ( EDAD ) exists in subjects with impaired fasting glucose ( IFG ) . The crucial mechanism of this endothelial dysfunction remains unclear . We hypothesized that oxidative stress may be partially responsible for the impairment in EDAD in subjects with IFG . Thus , the present study was design ed to assess whether the antioxidant α-lipoic acid can improve endothelial dysfunction in subjects with IFG . Sixty subjects with newly diagnosed IFG and 32 healthy individuals with normal glucose tolerance were enrolled . Subjects were r and omized into 2 groups : untreated experimental group ( n = 30 ) and α-lipoic acid treatment group ( n = 30 , α-lipoic acid 600 mg via intravenous infusion once a day for 3 weeks ) . We measured EDAD at baseline and after 3 weeks of intervention . At baseline , EDADs in α-lipoic acid and untreated experimental groups were 4.03 % and 4.14 % , respectively , which were significantly lower than that in controls ( 5.72 % ) ( P increase in EDAD ( reaching 5.10 % ; ΔEDAD , 26.5 % ) ( P decrease in plasma thiobarbituric acid reactive substances ( TBARS ) ( 29.1 % ) ( P α-lipoic acid . Endothelium-dependent arterial dilation and TBARS remained unchanged before and after intervention in the untreated experimental group . The absolute changes in EDAD showed a significant negative correlation with the changes in TBARS ( r = -0.444 , P = .014 ) . Our data showed that IFG subjects have impaired endothelial function and that antioxidant α-lipoic acid can improve endothelial function through a decrease of oxygen-derived free radicals ",
"BACKGROUND Takotsubo syndrome is a stress cardiomyopathy , characterized by reversible left ventricle ( LV ) apical ballooning in the absence of significant angiographic coronary artery stenosis . The frequent association with emotional stress suggests in this disease an autonomic nervous system involvement . We could think that a therapeutic treatment targeting heart sympathetic dysfunction could be of crucial importance . METHODS From January 2010 to June 2012 , 886 patients were consecutively evaluated at Cardarelli Hospital , Naples , Italy . Among these , 48 patients met takotsubo cardiomyopathy ( TCM ) criteria . Each patient was assessed with history and physical examination , 12-lead electrocardiogram , serum troponin , coronary arteriography , and left ventricular angiogram , perfusion myocardial scintigraphy with technetium 99 m , with echocardiography and 123I-metaiodobenzylguanidine ( MIBG ) myocardial scintigraphy . At discharge , the surviving patients were r and omly assigned to α-lipoic acid ( ALA ) treatment ( 600 mg once daily ) or placebo . Following discharge , after the initial TCM event , patients returned to our outpatient clinic at Internal Medicine of the Second University Naples for the follow-up evaluation quarterly until 12 months . Routine analysis , myocardial damage serum markers , oxidative stress serum markers , pro-inflammatory cytokines , and sympathetic tone activity were evaluated in all patients . RESULTS ALA administration improved MIBG defect size at 12 months compared to placebo . CONCLUSIONS Adrenergic cardiac innervation dysfunction in TCM patients persists after previous experience of transient stress-induced cardiac dysfunction . ALA treatment improves the adrenergic cardiac innervation . This study evaluates whether sympatho-vagal alterations are TCM event-related",
"Background Abnormal regulation of the inflammatory response is an important component of diseases such as diabetes , Alzheimer 's disease and multiple sclerosis ( MS ) . Lipoic acid ( LA ) has been shown to have antioxidant and anti-inflammatory properties and is being pursued as a therapy for these diseases . We first reported that LA stimulates cAMP production via activation of G-protein coupled receptors and adenylyl cyclases . LA also suppressed NK cell activation and cytotoxicity . In this study we present evidence supporting the hypothesis that the anti-inflammatory properties of LA are mediated by the cAMP/PKA signaling cascade . Additionally , we show that LA oral administration elevates cAMP levels in MS subjects . Methodology /Principal Findings We determined the effects of LA on IL-6 , IL-17 and IL-10 secretion using ELISAs . Treatment with 50 µg/ml and 100 µg/ml LA significantly reduced IL-6 levels by 19 and 34 % , respectively , in T cell enriched P BMC s. IL-17 levels were also reduced by 35 and 50 % , respectively . Though not significant , LA appeared to have a biphasic effect on IL-10 production . Thymidine incorporation studies showed LA inhibited T cell proliferation by 90 % . T-cell activation was reduced by 50 % as measured by IL-2 secretion . Western blot analysis showed that LA treatment increased phosphorylation of Lck , a downstream effector of protein kinase A. Pretreatment with a peptide inhibitor of PKA , PKI , blocked LA inhibition of IL-2 and IFN gamma production , indicating that PKA mediates these responses . Oral administration of 1200 mg LA to MS subjects result ed in increased cAMP levels in P BMC s four hours after ingestion . Average cAMP levels in 20 subjects were 43 % higher than baseline . Conclusions / Significance Oral administration of LA in vivo result ed in significant increases in cAMP concentration . The anti-inflammatory effects of LA are mediated in part by the cAMP/PKA signaling cascade . These novel findings enhance our underst and ing of the mechanisms of action of LA ",
"OBJECTIVE Type 1 diabetes is associated with increased platelet reactivity . We investigated whether α-lipoic acid ( ALA ) has any effect on platelet reactivity in these patients . RESEARCH DESIGN AND METHODS We r and omly assigned 51 type 1 diabetic patients to ALA ( 600 mg once daily ) or placebo for 5 weeks . Platelet reactivity was evaluated by the PFA-100 method and by measuring CD41 and CD62 platelet expression . C-reactive protein ( CRP ) and 8-iso-prostagl and in F2α serum levels also were measured . RESULTS Baseline variables were similar in the two groups . After treatment , closure time was longer ( P = 0.006 ) and CD62P platelet expression was lower , both before ( P = 0.002 ) and after ( P = 0.009 ) ADP stimulation in the ALA group compared with the placebo group . CRP and 8-iso-prostagl and in F2α levels showed no differences between the two groups . CONCLUSIONS Our data show that ALA reduces measures of platelet reactivity ex vivo in type 1 diabetic patients , independently of antioxidant or anti-inflammatory effects",
"Introduction Anemia associated with chronic kidney disease is a serious complication necessitating expenditure of huge medical efforts and re sources . This study investigates the role of alpha-lipoic acid ( ALA ) in end stage renal disease patients undergoing hemodialysis . By the virtue of its antioxidative effects , ALA is expected to act as an erythropoietin ( EPO ) adjuvant , and also has extended beneficial effects on endothelial dysfunction . Methods Forty-four patients undergoing hemodialysis and receiving EPO were r and omized into two groups : the first group received ALA 600 mg once daily for 3 months ; while the other group represented the control group . Parameters measured at baseline and at end of study were hemoglobin , EPO doses , EPO resistance index ( ERI ) , iron store indices , malondialdehyde , oxidized low-density lipoprotein ( ox-LDL ) , interleukin-6 ( IL-6 ) , tumor necrosis factor-α ( TNF-α ) , and asymmetric dimethylarginine ( ADMA ) , as well as routine laboratory follow-up . Results EPO doses and ERI were significantly decreased in the treatment group , while they did not change in the control group . Hemoglobin , iron store indices , malondialdehyde , oxidized ox-LDL , IL-6 , TNF-α , and ADMA were similar in both treatment and control groups at baseline , and did not change by the end of study period . Likewise , routine laboratory measures were not affected by the treatment . Conclusion ALA could be used in hemodialysis patients to reduce requirements for EPO . However , larger and longer term studies are required to clarify the exact role of ALA in hemodialysis as well as in pre-hemodialysis patients",
"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",
"Background Chronic renal failure is a progressive and irreversible loss of kidney function , and the hemodialysis ( HD ) is one of the most common modalities in this regard . Oxidative stresses [ like interleukin-8 ( IL-8 ) and tumor necrosis factor-alpha ( TNF-α ) ] and inflammation are the main risk factors associated with cardiovascular diseases and other complications in many organs in hemodialysis patients ; meanwhile , antioxidants like alpha lipoic acid ( ALA ) may reduce the oxidative stress markers and the levels of inflammatory cytokines , so can improve of the patient ’s quality of life . Methods In this r and omized clinical trial study , 60 HD patients were r and omly categorized in two case and control groups . Case group received a daily capsule of 600 mg of ALA supplementation for 8 weeks , and the control group received placebo capsules daily . The serum level of IL-8 and TNF-α was measured in both groups before and after the intervention . Results There were no significant differences in age , gender , duration of dialysis , and causative factor for dialysis between both groups ( P > 0.05 ) . The mean of IL-8 and TNF-α after the intervention in case group was 26.20 ± 15.34 and 21.25 ± 9.61 , respectively ; the difference between both groups was not statistically significant ( P > 0.05 ) . Conclusion Based on the better feeling and other beneficial effects of ALA were found in our study ; we can conclude that it is a beneficial and recommended supplement , especially , for diabetic and dialysis patients",
"OBJECTIVE We examined the effects of alpha-lipoic acid ( ALA ) supplementation on inflammation , oxidative stress , and serum lipid profile levels in hemodialysis ( HD ) patients . DESIGN This was a double-blinded , r and omized , placebo-controlled clinical trial . SETTING The present study involved HD centers in Tabriz , Iran . PATIENTS Participants included 63 patients with end-stage renal disease ( 43 men and 20 women ; age range : 22 - 79 years ) undergoing maintenance HD . INTERVENTION HD patients were r and omly assigned into the supplemented group ( n = 31 ) , receiving a daily dose of ALA ( 600 mg ) , or a control group ( n = 32 ) , receiving placebo for 8 weeks . MAIN OUTCOME MEASURES High sensitivity C-reactive protein ( hsCRP ) , malondialdehyde , total antioxidant status , total cholesterol , triglyceride , high-density lipoprotein cholesterol ( HDL-C ) , and low-density lipoprotein cholesterol ( LDL-C ) were measured at baseline and after 8 weeks of supplementation . RESULTS At the end of intervention , 11 patients were excluded from the study . HsCRP levels decreased by 18.7 % in the supplemented group after 8 weeks of supplementation , and the reduction was significant in comparison with the placebo group ( P mean malondialdehyde and total antioxidant status levels did not change significantly in the 2 groups during the study . The mean high-density lipoprotein cholesterol concentrations increased significantly in the supplemented group at the end of the study ( P lipid profile parameters within each group during the study . CONCLUSION ALA supplementation significantly reduced hsCRP levels , which is a risk factor for cardiovascular disease in HD patients",
"Study design : A r and omized , double-blind , placebo-controlled clinical trial . Objective : To assess the effect of alpha-lipoic acid ( ALA ) supplementation on IL-6 , hs-CRP , FBS , anthropometric indices , food intake and blood pressure in male patients with chronic spinal cord injury ( SCI ) . Setting : Imam Khomeini Hospital , Tehran University of Medical Sciences , Tehran , Iran . Methods : Fifty-eight men with chronic SCI participated in the study . Participants were divided in two groups : one group received 600 mg of supplemental ALA ( n=28 ) and the other group received placebo ( n=30 ) for 12 weeks . At the beginning and end of the study , biochemical parameters , anthropometric indices , blood pressure and dietary intakes were measured . Dietary intake was measured using N4 software , and statistical analyses were carried out using SPSS16 . Results : No significant reduction was found in IL-6 ( P=0.97 ) and hs-CRP levels ( P=0.23 ) . There was significant reduction in fasting blood sugar ( P=0.001 ) , body weight ( P=0.001 ) , BMI ( P=0.001 ) , waist circumference ( P=0.001 ) and blood pressure ( P=0.001 ) . Dietary intake was significantly reduced , including fat ( P=0.001 ) , carbohydrate ( P=0.001 ) , protein ( P=0.002 ) and energy intakes ( P=0.001 ) . Conclusion : Lipoic acid supplementation had no significant effect on the measured inflammatory markers but it reduces fasting blood sugar , anthropometric parameters , food intake and blood pressure in men with chronic SCI",
"INTRODUCTION Increased oxidative stress , inflammation , and malnutrition are present in hemodialysis patients and these factors exacerbate cardiovascular comorbidities . Vitamin E and alpha-lipoic acid ( ALA ) may have a protective role against cardiovascular disease risk factors via anti-oxidative and anti-inflammatory properties . The aim of this study was to evaluate the effect of ALA and vitamin E administration ( alone or combined ) on hemodialysis-induced stress oxidation , inflammation , and malnutrition . MATERIAL S AND METHODS In a r and omized placebo-controlled trial , we examined the effects of 2-month supplementation by vitamin E and ALA ( alone or combined ) on biomarkers of lipid peroxidation ( malondialdehyde ) , inflammation ( high-sensitivity C-Reactive protein and interleukin-6 ) , and malnutrition ( Subjective Global Assessment and body mass index ) in 85 hemodialysis patients receiving ALA ( 600 mg ) , vitamin E ( 400 IU ) , ALA and vitamin E , and placebo . RESULTS After supplementation , no significant changes were observed in malondialdehyde level ; however , there was a decrease in the ALA and vitamin E group during the period of the study . Also , a nonsignificant decrease was seen in the high-sensitivity C-Reactive protein concentration of the interventional groups . Supplementation of vitamin E with and without ALA significantly reduced interleukin-6 concentration . A significant improvement was observed in malnutrition status of all groups . CONCLUSIONS Vitamin E and ALA supplementation , especially their combination , might improve inflammation and malnutrition status , which suggest it as a potential preventive strategy against CVD among end-stage renal disease patients",
"Abstract Objective To evaluate the effect and toxicity of alprostadil combined with thioctic acid injection in the treatment of patients with diabetic nephropathy ( DN ) . Methods Sixty two patients with DN were included in this study and r and omly divided into control group ( n=32 ) and experiment group ( n=30 ) . Patients in the control group were given alprostadil 20ug+NS 100ml ivgtt , qd and patients in the experiment group were given alprostadil 20ug+NS 100ml ivgtt combined with thioctic acid injection of 0.45g+100ml ivgtt , qd for 14 days . After treatment , the renal function and serum level of CRP , IL-6 and TNF-α were compared between the two groups . Results After two weeks of treatment , the serum level of CysC and UAER significant decreased for both control and experiment group with statistical difference of p the serum level of CysC were 1.40 ±0.46 mg/L and 1.02±0.33 for control and experiment group respectively ( p The post-treatment UAER in experiment group was significantly lower than those of control group with statistical difference ( 81.02±0.33 vs112.45±20.32 , p were significantly decreased after treatment for both control and experiment group ( p the post-treatment serum CRP , IL-6 and TNF-α in experiment group were significantly lower than those of control group with statistical difference ( p ) . No significant side effects were found for the two groupsin the course of treatment . Conclusion Alprostadil combined with α-lipoic acid may improve renal function in patients with diabetic nephropathy by decreasing the levels of serum inflammatory factors",
"Probiotic therapies are going to be an effective alternative therapeutic strategy in the treatment and management of diabetes . The mechanism behind the essential effects of probiotic therapies in diabetic patients was not fully understood . The objective of this study was to evaluate the effects of probiotic soy milk containing Lactobacillus planetarum A7 on inflammation , lipid profile , fasting blood glucose , and serum adiponectin among patients with type 2 diabetes mellitus . Forty patients with type 2 diabetes , at the age of 35–68 years old , were assigned to two groups in this r and omized , double-blind , controlled clinical trial . The patients in the intervention group consumed 200 ml/day of probiotic soy milk containing L. planetarum A7 and those in control group consumed 200 ml/day of pure soy milk for 8 weeks . Serum TNF-α , C reactive protein , adiponectin , lipid profile , and fasting blood glucose were determined before and after intervention . In intervention group , serum adiponectin in pre- and post-treatment did not show any significant changes ( 2.52 ± 0.74 vs 2.84 ± 0.61 , P = 0.658 ) , as well as changes in serum TNF-α and C reactive protein ( 172.44 ± 5.7 vs 172.83 ± 7.6 , P = 0.278 , 4.2 ± 1.4 vs 4.5 ± 1.9 , P = 0.765 , respectively ) . Low-density cholesterol and high-density cholesterol changed significantly ( P = 0.023 , P = 0.017 , respectively ) , but fasting blood glucose did not show any significant changes . The results of this study showed that consumption of probiotic soy milk and soy milk has no effect on serum adiponectin and inflammation , but it can change lipid profile among type 2 diabetic patients",
"AIM The aim of the present study was to examine the pharmacokinetics of racemic alpha-lipoic acid in twelve healthy volunteers following single oral administration of 200 and 600 mg ( Thioctacid 200 film tablets ) . SUBJECTS , MATERIAL AND METHODS Each film tablet contained 200 mg of alpha-lipoic acid . In addition , an injection solution containing 200 mg of alpha-lipoic acid was administered . Plasma concentrations of alpha-lipoic acid were determined using a vali date d reversed-phase HPLC method with electrochemical detection having a lower limit of quantitation of 1 ng/ml . The areas under curve ( AUC ) were 46.82 + /- 21.46 and 157.97 + /- 35.05 microg x min/ml for the oral and intravenous administration of 200 mg , respectively . RESULTS The AUC following oral administration of 600 mg was 157.83 + /- 35.82 microg x min/ml . The difference in mean t(1/2 ) for the two oral doses and the i.v . dose ( in the range of 25.3 - 32.7 min ) was not statistically significant . CONCLUSION The lack of a significant difference between values for apparent total plasma clearance for the 200 and 600 mg doses indicates non-saturable kinetics of alpha-lipoic acid in healthy volunteers in this dose range . The absolute bioavailability after the 200 mg dose was 29.1 + /- 10.3 %",
"OBJECTIVE To examine the effects of alpha-lipoic acid ( ALA ) treatment over a period of 2 months on fasting blood glucose ( FBG ) , insulin resistance ( IR ) , and glutathione peroxidase ( GH-Px ) activity in type 2 diabetes ( T2DM ) patients . METHODS This study took place in Motahari Clinic , Shiraz , Iran , which is affiliated to Shiraz University of Medical Sciences from May to October 2006 . Type 2 DM patients ( n=57 ) were divided into 2 groups to receive either ALA ( 300 mg daily ) or placebo by systematic r and omization , and were followed-up for 8 weeks . After an overnight fasting and 2 hours after breakfast , patients ' blood sample s were drawn and tested for FBG , 2 hours PPG , serum insulin level , and GH-Px activity . RESULTS The result of the study showed a significant decrease in FBG and PPG levels , IR-Homeostasis Model Assessment ( IR-HOMA index ) and GH-Px level in the ALA group . The comparison of differences between FBG and IR at the beginning and at the end of study in the ALA treated group and the placebo group were also significant . CONCLUSION This study supports the use of ALA as an antioxidant in the care of diabetic patients",
"There is a growing evidence that excess generation of highly reactive free radicals , largely due to hyperglycemia , causes oxidative stress , which further exacerbates the development and progression of diabetes and its complications . The purpose of this study was to evaluate the impact of ALA on lipid profile , oxidative pattern and inflammation in patients with controlled non-insulin dependent diabetes mellitus ( NIDDM ) . ALA , 400mg/day was investigated in NIDDM patients over a period of 4 weeks using a r and omized , placebo-(PLA)-controlled study with two parallel groups . The marker of oxidative stress was the concentration of reactive oxygen metabolites , evaluated using a commercially available test , called d-ROMs test , and the biological antioxidant potential ( BAP ) ; besides , the lipid profile ( total cholesterol = TC , high-density lipoprotein-cholesterol = HDL-C ; low-density lipoprotein-cholesterol = LDL-C , and triglycerides = TG ) and the C-reactive protein ( CRP ) , marker of inflammation were measured at the beginning and at the end of the treatment . A total of 14 patients were r and omly assigned to the two groups . ALA was safe and well tolerated in the only oral daily administration . The d-ROMs test ( p=0.03 ) and HDL-C ( p=0.04 ) showed a significant difference between the two groups . BAP ( p=0.06 ) tended to be higher in the treated patients , while LDL-C ( p=0.07 ) presented a moderate decline . There were no significant differences in TC ( p=0.65 ) , TG ( p=0.78 ) and CRP ( p=0.96 ) between the ALA and PLA groups . ALA therapy appears to reduce significantly d-ROMs and to improve HDL-C value , especially in men with metabolic syndrome treated with oral hypoglycemic drugs . These findings will be useful in patient selection in future clinical trials with ALA in long term studies",
"BACKGROUND Oxidative stress plays an important role in the development of diabetic cardiomyopathy . Alpha-lipoic acid ( ALA ) is a powerful antioxidant that may have a protective role in diabetic cardiac dysfunction . AIM We investigated the possible beneficial effect of alpha-lipoic acid on diabetic left ventricular ( LV ) dysfunction in children and adolescents with asymptomatic type 1 diabetes ( T1D ) . SUBJECTS AND METHODS Thirty T1D patients ( aged 10 - 14 ) were r and omized to receive insulin treatment ( n = 15 ) or insulin plus alpha-lipoic acid 300 mg twice daily ( n = 15 ) for four months . Age and sex matched healthy controls ( n = 15 ) were also included . Patients were evaluated with conventional 2-dimensional echocardiographic examination ( 2D ) , pulsed tissue Doppler ( PTD ) , and 2-dimensional longitudinal strain echocardiography ( 2DS ) before and after therapy . Glutathione , malondialdhyde ( MDA ) , nitric oxide ( NO ) , tumor necrosis factor-alpha ( TNF-alpha ) , Fas lig and ( Fas-L ) , matrix metalloproteinase 2 ( MMP-2 ) , and troponin-I were determined and correlated to echocardiographic parameters . RESULTS Diabetic patients had significantly lower levels of glutathione and significantly higher MDA , NO , TNF-alpha , Fas-L , MMP-2 , and troponin-I levels than control subjects . The expression of transforming growth factor beta ( TGF-beta ) mRNA in peripheral blood mononuclear cells was also increased in diabetic patients . Significant correlations of mitral e'/a ' ratio and left ventricular global peak systolic strain with glutathione , MDA , NO , TNF-alpha , and Fas-L were observed in diabetic patients . Alpha-lipoic acid significantly increased glutathione level and significantly decreased MDA , NO , TNF-alpha , Fas-L , MMP-2 , troponin-I levels , and TGF-beta gene expression . Moreover , alpha-lipoic acid significantly increased mitral e'/a ' ratio and left ventricular global peak systolic strain in diabetic patients . CONCLUSION These findings suggest that alpha-lipoic acid may have a role in preventing the development of diabetic cardiomyopathy in type 1 diabetes",
"Prevention of hepatic fat accumulation may be an important approach for liver diseases due to the increased relevance of hepatic steatosis in this field . This study was conducted to investigate the effects of the antioxidant α-lipoic acid ( α-LA ) on hepatic steatosis , hepatocellular function , and oxidative stress in a model of type 2 diabetes fed with a high fat diet ( HFD ) . Goto-Kakizaki rats were r and omly divided into four groups . The first group received only a st and ard rat diet ( control GK ) including groups 2 ( HFD ) , 3 ( vehicle group ) , and 4 ( α-LA group ) , which were given HFD , ad libitum during three months . Wistar rats are the non-diabetic control group . Carbohydrate and lipid metabolism , liver function , plasma and liver tissue malondialdehyde ( MDA ) , liver GSH , tumor necrosis factor-α ( TNF-α ) and nuclear factor E2 ( erythroid-derived 2)-related factor-2 ( Nrf2 ) levels were assessed in the different groups . Liver function was assessed using quantitative hepatobiliary scintigraphy , serum aspartate , and alanine aminotransferases ( AST , ALT ) , alkaline phosphatase , gamma-glutamyltranspeptidase , and bilirubin levels . Histopathologically steatosis and fibrosis were evaluated . Type 2 diabetic animals fed with HFD showed a marked hepatic steatosis and a diminished hepatic extraction fraction and both were fully prevented with α-LA . Plasma and liver tissue MDA and hepatic TNF-α levels were significantly higher in the HFD group when compared with the control group and significantly lower in the α-LA group . Systemic and hepatic cholesterol , triglycerides , and serum uric acid levels were higher in hyperlipidemic GK rats and fully prevented with α-LA . In addition , nuclear Nrf2 activity was significantly diminished in GK rats and significantly augmented after α-LA treatment . In conclusion , α-LA strikingly ameliorates steatosis in this animal model of diabetes fed with HFD by decrementing the inflammatory marker TNF-α and reducing oxidative stress . α-LA might be considered a useful therapeutic tool to prevent hepatic steatosis by incrementing antioxidant defense systems through Nrf2 and consequently decreasing oxidative stress and inflammation in type 2 diabetes",
"Catheter ablation ( CA ) is a procedure commonly used to restore sinus rhythm in patients with atrial fibrillation ( AF ) . However , AF recurrence after CA remains a relevant clinical issue . We tested the effects of an oral antioxidant treatment ( alpha lipoic acid [ ALA ] ) on AF recurrence post-CA . Patients with paroxysmal AF have been enrolled in a r and omized , prospect i ve , double-blind , controlled placebo trial . After CA , patients have been r and omly assigned to receive ALA oral supplementation ( ALA group ) or placebo ( control group ) and evaluated at baseline and after a 12-month follow-up : 73 patients completed the 12-month follow-up ( ALA : 33 and control : 40 ) . No significant difference has been detected between the 2 groups at baseline . Strikingly , 1 year after CA , ALA therapy significantly reduced serum markers of inflammation . However , there was no significant difference in AF recurrence events at follow-up comparing ALA with placebo group . Multivariate analysis revealed that the only independent prognostic risk factor for AF recurrence after CA is age . In conclusion , ALA therapy reduces serum levels of common markers of inflammation in ablated patients . Nevertheless , ALA does not prevent AF recurrence after an ablative treatment"
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BACKGROUND Perioperative shivering is clinical ly common during cesarean sections under neuraxial anesthesia , and several neuraxial adjuvants are reported to have preventive effects on it . However , the results of current studies are controversial and the effects of these neuraxial adjuvants remain unclear . AIM To evaluate the effects of neuraxial adjuvants on perioperative shivering during cesarean sections , thus providing an optimal choice for clinical application . METHODS A systematic review and network meta- analysis were conducted following the PRISMA ( Preferred Reported Items for Systematic Review and Meta- analysis ) guidelines . Analyses were performed using Review Manager 5.3 and Stata 14.0 . We search ed PubMed , EMBASE , Web of Science , and Cochrane Central data bases for eligible clinical trials assessing the effects of neuraxial adjuvants on perioperative shivering and other adverse events during cesarean sections . Perioperative shivering was defined as the primary endpoint , and nausea , vomiting , pruritus , hypotension , and bradycardia were the secondary outcomes . RESULTS Twenty-six studies using 9 neuraxial adjuvants for obstetric anesthesia during caesarean sections were included . The results showed that , compared with placebo , pethidine , fentanyl , dexmedetomidine , and sufentanil significantly reduced the incidence of perioperative shivering . Among the four neuraxial adjuvants , pethidine was the most effective one for shivering prevention ( OR = 0.15 , 95%CI : 0.07 - 0.35 , surface under the cumulative ranking curve 83.9 ) , but with a high incidence of nausea ( OR = 3.15 , 95%CI : 1.04 - 9.57 ) and vomiting ( OR = 3.71 , 95%CI : 1.81 - 7.58 ) . The efficacy of fentanyl for shivering prevention was slightly inferior to pethidine ( OR = 0.20 , 95%CI : 0.09 - 0.43 ) , however , it significantly decreased the incidence of nausea ( OR = 0.34 , 95%CI : 0.15 - 0.79 ) and vomiting ( OR = 0.25 , 95%CI : 0.11 - 0.56 ) . In addition , compared with sufentanil , fentanyl showed no impact on haemodynamic stability and the incidence of pruritus . CONCLUSION Pethidine , fentanyl , dexmedetomidine , and sufentanil appear to be effective for preventing perioperative shivering in puerperae undergoing cesarean sections . Considering the risk-benefit profiles of the included neuraxial adjuvants , fentanyl is probably the optimal choice
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"Background : Intrathecal adjutants can be used for regional anesthesia ( RA ) in cesarean section to improve its quality in terms of time and complications . Some previous studies focused on the effects of adding sufentanil and /or midazolam to bupivacaine and compared each with using bupivacaine alone . However , there has been no study to assess the effects of using sufentanil and midazolam in combination with bupivacaine . Objectives : The aim of this study was to evaluate and compare properties ( time of achievement/recovery of sensory/motor blocks ; and time to request opium ) , complications ( nausea , vomiting , shivering and hypotension ) , and neonatal first minute Apgar score with and without the addition of midazolam ( M ) or sufentanil ( S ) to bupivacaine ( B ) through intrathecal injection for spinal anesthesia , after the cesarean section . Patients and Methods : In this double blind r and omized clinical trial participants were r and omly allocated to three equal groups : Group B ( 2.5 cc of bupivacaine 0.5 % + 1 cc normal saline 0.9 % ) , Group BM ( 2.5 cc of bupivacaine + 0.02 mg/kg midazolam ) and Group BS ( 2.5 cc of bupivacaine 0.5 % + 0.7 cc normal saline 0.9 % + 1.5 µg of sufentanil , 0.3 cc ) . We used analysis of variance ( ANOVA ) , post hoc test with Bonferroni adjustment , and chi-square test for statistical analysis ; the analyses were performed using the SPSS-16 software . Given a significant level of 0.05 , overall and pair-wise comparisons were made . Results : Seventy-five females participated in the study with no significant age difference ( mean ± st and ard deviation ( SD ) : 28.60 ± 6.06 , 28.12 ± 5.29 and 28.76 ± 3.97 year ; P = 0.9 ) . Except for “ time to motor block recovery ” ( P = 0.057 ) , the overall differences among the three groups was significant in terms of “ time to sensory/motor block ” ( P ) , “ time to sensory block recovery ” ( P and “ time to request opium ” ( P “ time to request opium ” , which was longer in the BS group ( P occurrence of nausea ( P = 0.02 ) , postoperative shivering ( P = 0.01 ) and hypotension ( P Apgar score of nine . Conclusions : The findings showed that adding sufentanil or midazolam to bupivacaine shortens the onset of spinal anesthesia and increases the time duration of anesthesia ; however it does not change the motor block recovery time . Adding sufentanil delays the first request for narcotic analgesics while adding midazolam leads to a decrease in nausea and hypotension . Adding sufentanil or midazolam does not have any deleterious effect on infants ’ Apgar scores . However , increases shivering in patients",
"Background Shivering related to spinal anesthesia may interfere with monitoring and is uncomfortable . The aim of the present study was to investigate low-dose intrathecal meperidine for the prevention of shivering after induction of spinal anesthesia in parturients with cesarean section . Methods This was a prospect i ve r and omized , double-blind , placebo-controlled trial including 100 parturients , of American Society of Anesthesiologists ( ASA ) physical status I or II , scheduled for elective cesarean section under spinal anesthesia who were r and omly assigned to a meperidine ( 0.2 mg/kg ) plus hyperbaric lidocaine ( 5 % , 75 mg , n = 50 ; group M ) group or a placebo plus hyperbaric lidocaine ( 5 % , 75 mg , n = 50 ; group L ) group . Demographic and surgical data , adverse events , and the mean intensity for each parturient were assessed during the entire study period by a blinded observer . Results There were no significant differences between the two study groups regarding the demographic and surgical data ( P > 0.05 ) . The incidence of shivering during the entire study period significantly decreased in the group of parturients who received intrathecal meperidine ( P = 0.04 ) . There were no significant differences in nausea and vomiting between the two groups . Conclusions Low-dose intrathecal meperidine ( 10 mg ) is safe and effective in reducing the incidence and severity of shivering associated with spinal anesthesia in parturients with cesarean section",
"Shivering associated with spinal anesthesia during Cesarean delivery is an uncomfortable experience for the parturient , which may also cause adverse effects . In this prospect i ve , r and omized , double-blind , placebo-controlled study , we sought to evaluate the effect of intrathecal dexmedetomidine , administered as an adjunct to hyperbaric bupivacaine for Cesarean delivery , on the incidence and severity of shivering associated with spinal anesthesia . Patients undergoing Cesarean delivery were r and omly allocated to three groups of 30 patients each . Experimental treatments were added to hyperbaric bupivacaine as follows : Patients in group I ( control ) were administered isotonic saline . Patients in groups II and III received dexmedetomidine ( 2.5 , 5 µg , respectively ) , mixed with isotonic saline . Shivering was observed in 11 , 10 and 2 patients in groups I , II and III , respectively . The incidence of shivering in group III was significantly lower than that in groups I ( p=0.005 ) and II ( p=0.01 ) . The severity of shivering was significantly different between the three groups ( p=0.01 ) . There were no significant inter-group differences with respect to mean arterial pressure and heart rate at any time point after administration of intrathecal local anesthesia ( p>0.05 ) . Intrathecal dexmedetomidine ( 5 µg ) administered as an adjunct to hyperbaric bupivacaine during Cesarean delivery significantly reduced the incidence and intensity of shivering associated with spinal anesthesia ",
"Background : Shivering , the rate of which in regional anesthesia is 39 % is an undesired complication seen postoperatively . Aims : This study aims to compare the ability of preventing the shivering of preemptive tramadol and dexmedetomidine during the spinal anesthesia ( SA ) . Methods : A total of 90 patients with American Society of Anesthesiologists physical status I-II , aged 18 - 60 years and undergoing elective arthroscopic surgery with SA were divided into three groups r and omly . After spinal block , 100 mg tramadol in 100 ml saline was applied in group T- ( n = 30 ) and 0.5 μg/kg dexmedetomidine in 100 ml saline was applied in group D- ( n = 30 ) and 100 ml saline was administered in group P- ( n = 30 ) in 10 min . The hemodynamics , oxygen saturation , tympanic temperature , shivering and sedation scores were evaluated and recorded intraoperatively and 45 min after a postoperative period . Results : In group T and D , shivering scores were significantly lower when compared with group P in the intraoperative 20th min ( P = 0.01 ) . Sedation scores in group D were significantly higher than the baseline values ( P = 0.03 ) and values in group T and P ( P = 0.04 ) . Conclusions : Preemptive tramadol and dexmedetomidine are effective in preventing the shivering under SA . In addition , dexmedetomidine was superior in increasing the level of sedation which is sufficient to prevent the anxiety without any adverse effects",
"BACKGROUND Intrathecal tramadol combined with local anaesthetics has been used for postoperative analgesia following lower abdominal and perineal surgery . The present study evaluated the effect of intrathecal tramadol on spinal block characteristics and neonatal outcome after elective caesarean section . METHODS Eighty full-term parturients scheduled for elective caesarean section were r and omly divided into two groups . In the fentanyl group , patients received intrathecal 0.5 % bupivacaine 10 mg with fentanyl 10 μg ; in the tramadol group , patients were given the same dose of bupivacaine with tramadol 10 mg . Sensory and motor block characteristics , duration of postoperative analgesia , maternal side effects , and neonatal outcome were compared . RESULTS One patient in the tramadol group and two patients in the fentanyl group were excluded from data analysis . Median [ interquartile range ] duration of postoperative analgesia in the tramadol and the fentanyl groups was 300 [ 240 - 360 ] min and 260 [ 233 - 300 ] min respectively ( P = 0.02 ) . The incidence of shivering was lower in patients who received tramadol ( 5 % ) than those who had fentanyl ( 32 % ) ( P = 0.003 ) . Apgar scores , umbilical cord acid-base measurement and neurologic and adaptive capacity scores were comparable between the two groups . CONCLUSION Compared to intrathecal fentanyl 10 μg , tramadol 10 mg , as an adjunct to bupivacaine for subarachnoid block for caesarean section , showed a longer duration of analgesia with a reduced incidence of shivering ",
"We performed a prospect i ve , r and omised , double blind study to compare the antishivering effect of morphine and pethidine when added to intrathecal hyperbaric bupivacaine during elective Caesarean delivery under combined‐spinal epidural anaesthesia . Spinal anaesthesia consisted of either 8–10 mg of 0.5 % bupivacaine alone ( group B ; n = 30 ) with 0.1 mg morphine ( group BM0.1 ; n = 29 ) , with 0.2 mg morphine ( group BM0.2 ; n = 30 ) , or with 10 mg pethidine ( group BPeth10 ; n = 30 ) . The incidences of shivering were 23.3 % ( 7/30 ) in group B , 17 % ( 5/29 ) in group BM0.1 , 13.3 % ( 4/30 ) in group BM0.2 and 3.3 % ( 1/30 ) in group BPeth10 ( p The shivering intensity for each patient was significantly higher in group B than the other groups . In conclusion , intrathecal pethidine added to hyperbaric bupivacaine reduces the incidence and intensity of shivering more than does morphine ( 0.1 or 0.2 mg )",
"BACKGROUND AND OBJECTIVES Shivering is a cause of discomfort and dissatisfaction in patients undergoing cesarean section . The objective of this study paper was to assess the impact of intrathecal administration of sufentanil on the incidence of shivering after cesarean section . METHOD In a prospect i ve blinded , r and omized clinical trial , pregnant women undergoing cesarean section under spinal anesthesia were enrolled . Pregnant women in labor , febrile , obese , with pregnancy-induced hypertension , anesthetic block failure or surgical complications were excluded . Patients were r and omly assigned to two groups . In Group I , 10 mg of 0.5 % hyperbaric bupivacaine combined with 80 mcg of morphine and 2.5 mcg of sufentanil were administered . In Group II , 10 mg of 0.5 % hyperbaric bupivacaine combined with 80 mcg of morphine were administered . In the post-anesthesia care unit , patients were evaluated for signs of shivering by an investigator blinded to the patient 's group allocation . RESULTS The sample consisted of 80 patients . In both groups there was a decrease in axillary temperature of patients after cesarean section ( p incidence of tremor was 32.5 % ( 13/40 ) and in Group II it was 62.5 % ( 25/40 ) ( p sufentanil to hyperbaric bupivacaine and morphine during spinal anesthesia for cesarean section provides a decrease in the incidence of shivering in the immediate postoperative period",
"Background and Objectives . Fentanyl at doses of 6.25 μg or more , when added to hyperbaric bupivacaine for spinal anesthesia for cesarean delivery , has been reported to markedly increase the duration of analgesia . In this study , subarachnoid fentanyl 15 μg was evaluated as the sole adjunct to hyperbaric lidocaine spinal anesthesia in parturients undergoing cesarean delivery at term , to determine its effect on the duration of analgesia and side effects perioperatively . Methods . Twenty-eight parturients scheduled for elective cesarean delivery at term were r and omized to one of two groups in a prospect i ve , double-blind fashion . Patients in group F received 15 μg fentanyl in addition to 80 mg hyperbaric lidocaine for subarachnoid anesthesia , while patients in group N received 0.3 mL normal saline in addition to 80 mg hyperbaric lidocaine . Visual analog pain scores were recorded preoperatively and at regular intervals until the first patient request for additional analgesia . The occurrence of side effects ( nausea , vomiting , pruritus , shivering ) was recorded at intervals for 4 hours postinduction . All patients received patient-controlled analgesia after delivery , and analgesic requirements for 24 hours postinduction were recorded . Results . There was no difference between groups with respect to visual analog pain scores intraoperatively . The mean duration of effective analgesia was increased in the patients receiving fentanyl from 71 minutes to 101 minutes ( Student 's t-test , P 4-hour or 24-hour analgesic requirements . Patients in group F were significantly less likely to experience nausea ( Fisher 's exact test , P vomiting ( chi-square test , P the incidence of pruritus or shivering . Conclusions . The addition of fentanyl 15 μg to hyperbaric lidocaine for subarachnoid anesthesia for cesarean delivery increases the duration of effective analgesia by approximately 30 minutes compared to plain hyperbaric lidocaine , and provides a protective effect regarding nausea and vomiting in the perioperative period",
"Background Shivering is one of the common problems in spinal anesthesia . The objective of the present study was to evaluate the effect of intrathecal fentanyl ( 25 µg ) on incidence and severity of intraoperative and postoperative shivering . Methods A double-blind r and omized controlled study was conducted in eighty healthy women ( ASA Physical status I ) scheduled for elective cesarean section under spinal anesthesia . Subjects were r and omly divided into two equal groups . The patients received 12.5 mg ( 2.5ml ) of 0.5 % hyperbaric bupivacaine combined with 25 µg ( 0.5 ml ) fentanyl in Group F as a study group and 12.5 mg ( 2.5ml ) of 0.5 % hyperbaric bupivacaine combined with 0.5 ml normal saline in Group S as a control group . Incidence of shivering during 30 and 60 minutes of surgery and recovery and complications were evaluated . Results The total incidence of shivering in Group F was significantly lower than Group S ( 10 % in group F ; 75 % in group S , p started shivering in the first hour after spinal anesthesia and the rate of shivering especially in second 30 minutes was higher than first 30 minutes in both groups . None in Group F but 22 patients ( 55 % ) in Group S had shivering during recovery and all of them reported shivering at the first 30 minute at recovery . The severity of shivering in Group F was significantly lower than Group S ( p Conclusion Intrathecal bupivacaine combined with fentanyl is associated with a lower incidence and severity of shivering",
"Background : The addition of opioid to local anaesthetics has become a well‐accepted practice of spinal anaesthesia for caesarean delivery . Successful caesarean delivery anaesthesia has been reported with the use of a low dose of intrathecal hyperbaric ropivacaine coadministered with sufentanil . This prospect i ve , double‐blinded study determined the median effective dose ( ED50 ) of intrathecal hyperbaric ropivacaine with and without sufentanil for caesarean delivery , to quantify the sparing effect of sufentanil on the ED50 of intrathecal hyperbaric ropivacaine ",
"Introduction Shivering is among the unpleasant and potentially harmful side effects of spinal anesthesia . The aim of this r and omized double-blind clinical trial was to compare the antishivering effect of two different doses of intrathecal pethidine on the incidence and intensity of shivering and other side effects in patients who underwent cesarean section . Methods In this study , 150 parturient females scheduled for nonemergent cesarean section were r and omly allocated to three groups . Spinal anesthesia was performed with 0.5 % hyperbaric bupivacaine ( 12.5 mg ) , plus 0.5 mL of 0.9 % saline in the st and ard group ( S group ) , and the same dose of bupivacaine with 5 mg ( P5 group ) or 10 mg of pethidine ( P10 group ) . Demographic and surgical data , incidence and intensity of shivering ( primary outcome ) , hemodynamic indices , forehead and core temperatures , maximum sensory level , Apgar scores , and adverse events were evaluated by a blinded observer . Results There were no significant differences between the three study groups regarding the demographic and surgical data , hemodynamic indices , core temperatures , and maximum sensory level ( P>0.05 ) . The incidence and intensity of shivering were significantly less in the P5 and P10 groups ( P pruritus , which was more common in the P5 and P10 groups when compared with the S group ( P=0.01 ) . Conclusion Low dose of intrathecal pethidine is safe , and can decrease the incidence and intensity of shivering during cesarean section , without having major side effects",
"Background Shivering is among the common troublesome complications of spinal anesthesia ( SA ) , and causes discomfort and discontentment in parturients undergoing cesarean sections ( CSs ) . The aim of this study was to investigate the effects of intrathecal dexmedetomidine in the prevention of shivering in those who underwent CS under SA . Subjects and methods Fifty parturients planned for elective CSs under SA were enrolled in this prospect i ve , double-blinded , controlled study and r and omly divided into two equal groups . Spinal block was achieved with 12.5 mg 0.5 % heavy bupivacaine plus 5 μg dexmedetomidine ( BD group ) or 0.5 mL 0.9 % normal saline ( BN group ) . The incidence and intensity of shivering , peripheral and core body temperature , hemodynamic parameters , and adverse events was recorded . Results The incidence of shivering was significantly higher in the BN group ( 52 % ) than the BD group ( 24 % ) ( P=0.04 ) . Likewise , the intensity of shivering was significantly higher in the BN group than the BD group ( P=0.04 ) . The incidence of adverse events , such as hypotension , nausea/vomiting , and bradycardia , was not significantly different between the two groups , although the grade of sedation was higher in the BD group than the BN group ( P=0.004 ) . Conclusion We conclude that intrathecal dexmedetomidine is effective in lowering the incidence and intensity of shivering in parturients undergoing CSs under SA without major adverse effects",
"Background Regional anesthesia is known to significantly impair thermoregulation and predispose patients to hypothermia . We hypothesized that the addition of an intrathecal injection of magnesium sulfate ( MgSO4 ) to bupivacaine would improve perioperative shivering in female patients undergoing elective caesarean section . Methods In a block-r and omized , double-blinded , controlled trial 72 patients scheduled for elective caesarean section with spinal anesthesia were separated into two groups . In the treatment group , 2 ml of 0.5 % bupivacaine plus 25 mg MgSO4 ( 0.5 ml ) were injected intrathecally , and in the control group 2 ml of 0.5 % bupivacaine plus 0.5 ml normal saline were injected intrathecally . Core temperature was measured before and after drug injection at predetermined intervals . Sedation was grade d using the Ramsay sedation scale . Results No significant intergroup differences in appearance of shivering were seen immediately or at 5 , 30 , 40 , 50 , 60 , and 90 min after block administration . However , at 10 , 15 , and 20 min post block , there was a significant difference in shivering . The group administered MgSO4 showed lower shivering grade s compared with the control group . Core temperature was significantly reduced in the MgSO4 group compared to the normal saline group 30 min after blocking . Conclusions Intrathecal injection of MgSO4 improved perioperative shivering in female patients undergoing elective caesarean section",
"This study was design ed to evaluate the effect of adding dexmedetomidine to regular mixture of epidural drugs for pregnant women undergoing elective cesarean section with special emphasis on their sedative properties , ability to improve quality of intraoperative , postoperative analgesia , and neonatal outcome . Material s and Methods : Fifty women of ASA physical status I or II at term pregnancy were enrolled r and omly to receive plain bupivacaine plus fentanyl ( BF Group ) or plain bupivacaine plus mixture of fentanyl and dexmedetomidine ( DBF Group ) . Incidence of hypotension , bradycardia , Apgar scores , intraoperative pain assessment , onset of postoperative pain , sedation scores , and side effects were recorded . Results : No difference in the times taken for block to reach T4 sensory level , to reach the highest level of sensory block , and interval between first neuraxial injection and onset of surgery between the groups was noted . Onset of postoperative pain was significantly delayed in the DBF group ( P = 0.001 ) , the need for supplementary fentanyl was significantly less in DBF group ( P = 0.03 ) , no significant difference was noted between both groups regarding neonatal Apgar scores as well as the incidence of hypotension , bradycardia , nausea , vomiting , and duration of motor blockade . DBF group had significantly less incidence of shivering ( P = 0.03 ) . Conclusion : Adding dexmedetomidine to regular mixture of epidural anesthetics in women undergoing elective cesarean section improved intraoperative conditions and quality of postoperative analgesia without maternal or neonatal significant side effects",
"OBJECTIVES The aim of this r and omized double-blind study was to investigate whether 20 microg of intrathecally administered fentanyl would influence the incidence and severity of shivering in patients undergoing cesarean section . MATERIAL AND METHOD Sixty healthy patients scheduled for cesarean section under spinal anesthesia using 2.2 ml of 0.5 % hyperbaric bupivacaine with 0.2 ml of morphine 0.2 mg , were r and omly allocated to receive an additional 0.4 ml of fentanyl 20 mg intrathecally ( Group F ) or normal saline 0.4 ml ( Group S ) . RESULTS The incidence of shivering three hours after spinal anesthesia was 6 of 30 patients , 20 % in Group F and 15 of 30 patients , 50 % in Group S. The difference was statistically significant ( p shivering patients started in their first hour after spinal anesthesia ( 5 patients in Group F and 13 patients in Group S ) . None in Group F but 4 patients in Group S started shivering before their babies were delivered . The shivering score was also significantly lower in Group F ( p shivering was requested in 16 % and 26 % of the shivering patients in Group F and Group S , respectively . There was no difference in the incidence of pharmacologic side effects . The core temperature did not differ significantly between the groups during 3 hours after spinal anesthesia . CONCLUSION The addition of 20 microg fentanyl in 2.2 ml of 0.5 % hyperbaric bupivacaine with 0.2 ml of morphine 0.2 mg intrathecally can reduce the incidence and severity of intraoperative and postoperative shivering after spinal anesthesia for patients who were receiving cesarean section without increasing other side effects",
" Background : So far only ropivacaine concentrations of 0.5 and 0.75 % have been used for Caesarean section . This prospect i ve double‐blind trial evaluated the anaesthetic quality of ropivacaine 1 % with and without sufentanil addition",
"To compare the effects of intrathecal dexmedetomidine and intrathecal morphine as supplements to bupivacaine in cesarean sections under spinal anesthesia . Full-term parturients ( n=120 ) undergoing elective cesarean sections under spinal anesthesia were r and omly allocated into three groups : Group B received 10 mg bupivacaine , Group BD received 10 mg bupivacaine plus 5 µg dexmedetomidine , and Group BM received 10 mg bupivacaine plus 100 µg morphine . The onset and regression time of sensory and motor blockade , postoperative analgesia , and side effects were recorded . Group BD showed quicker onset time and a longer sensory and motor blockade than other groups ( BD vs. B and BD vs. BM , p The mean time of sensory regression to the S1 segment was 253.21±42.79 min in group BD , 192.50±40.62 min in group BM and 188.33±37.62 min in group B ( p showed an analgesia duration ( time to requirement of first rescue analgesic ) ( 17.59±6.23 h ) similar to that of group BM ( 16.78±5.90 h ) but longer than that of group B ( 3.53±1.68 h ) ( p ) . The incidence of pruritus was significantly higher in group BM compared with groups BD and B ( p ) . Less shivering was observed in group BD than in groups BM and B ( p=0.009 ) . So intrathecal dexmedetomidine ( 5 µg ) prolonged the motor and sensory blockade , provided a similar analgesic effect and reduced pruritus and shivering compared with morphine ( 100 µg ) in cesarean sections",
"The effects of shivering on hemodynamics and systemic oxygenation , as well as the effectiveness of therapeutic interventions in decreasing shivering and increasing mixed venous oxygen saturation , were studied . Thirty adult patients undergoing cardiopulmonary bypass with systemic hypothermia were observed for 1 1/2 to 5 hours postoperatively for signs of shivering associated with a simultaneous decrease in oxygen transport . Systemic and pulmonary hemodynamic measurements were made , blood temperature and mixed venous oxygen saturation were monitored via the pulmonary arterial catheter , and oxygen consumption and delivery were calculated . Shivering was grade d by a single investigator on scale of 0 to 4 , with 0 = no shivering and 4 = continuous violent muscle activity . Therapy was instituted when shivering reached grade 4 or when SvO2 decreased to less than two thirds of its value on arrival in the intensive care unit ( ICU ) . Patients were r and omly assigned to receive either morphine sulfate , 5 to 10 mg , or meperidine , 25 to 50 mg intravenously ( IV ) , followed by the other narcotic if the initial drug failed to improve SvO2 or decrease shivering within ten minutes . The end-point for successful treatment was a return of SvO2 to within 5 % to 10 % of its value upon arrival in the ICU or a cessation of shivering that did not recur within 45 minutes . Twenty of the thirty patients shivered sufficiently to decrease SvO2 by more than one third of its initial value , thus requiring pharmacologic therapy . As shivering increased from a score of 0.8 + /- 1.1 to 3.4 + /- 0.9 , SvO2 decreased from 74 + /- 6 % to 57 + /- 12 % . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND Combined spinal-epidural anaesthesia is commonly used for elective caesarean section . Intrathecal injection produces rapid onset with minimal doses of local anaesthetic and epidural administration can be used to prolong the block . Our study examined the effects of adding magnesium sulphate to epidural bupivacaine and fentanyl in patients undergoing elective caesarean section using combined spinal-epidural anaesthesia . METHODS Women ASA physical status I or II at term were recruited . All received 2 mL intrathecal 0.5 % hyperbaric bupivacaine , 10 mL epidural 0.25 % plain bupivacaine with fentanyl 100 μg , and were r and omly allocated to receive either 10 mL of epidural 0.9 % sodium chloride or 10 mL epidural 5 % magnesium sulphate . The quality of surgical anaesthesia , incidence of hypotension , Apgar scores , intraoperative pain assessment , onset of postoperative pain , sedation scores and side effects were recorded in the postoperative period . RESULTS Ninety women were recruited . There was no difference in the time taken for the block to reach T4 sensory level , time to reach the highest level of sensory block , time interval between first neuraxial injection and onset of surgery between the groups . Women who received magnesium had greater motor block and muscle relaxation ( P ) . Apgar scores were 7 or more in almost all neonates in both groups . There was no significant difference in the incidence of hypotension , nausea and vomiting and duration of motor blockade between the groups . Women who received magnesium showed less shivering and later onset of post operative pain ( P addition of magnesium to epidural bupivacaine and fentanyl in women undergoing elective caesarean section with combined spinal-epidural anaesthesia improved intraoperative conditions and the quality of postoperative analgesia",
"Background and Context : Different adjuvants been tried out for neuraxial anesthesia in emergency caesarean section so that the dose of the local anesthetic can be reduced and hypotension thereby prevented . Aims and Objectives : The present study was carried out in patients presenting for emergency lower segment caesarean section ( LSCS ) to establish the dose of intrathecal clonidine that would allow reduction of the dose of local anesthetic ( thereby reducing the incidence and magnitude of hypotension ) while at the same time providing clinical ly relevant prolongation of spinal anesthesia without significant side effects . Material s and Methods : This r and omized clinical study was carried out in our institution among 100 pregnant females who underwent emergency caesarean section . The participants were divided r and omly into four groups : A , B , C , and D , each comprising 25 parturients . Subarachnoid block was performed using a 26 G Quincke needle , with 12 mg of hyperbaric bupivacaine ( LA ) in group A , 9 mg of LA + 30 μg of clonidine in group B , LA + 37.5 μg of clonidine in group C , and LA + 45 μg of clonidine in group D. The solution was uniformly made up to 2.2 mL with normal saline in all the groups . Onset of analgesia at T10 level , sensory and motor blockade levels , maternal heart rate and blood pressure , neonatal Apgar scores , postoperative block characteristics , and adverse events were looked for and recorded . Statistical analysis was carried out with SPSS ® version 10.0 for Windows ® , using the ANOVA test with post hoc significance , the Chi-square test , and the Mann-Whitney U test . P One hundred patients were enrolled for this study . The four groups were comparable with regard to demographic data and neonatal Apgar scores . Onset and establishment of sensory and motor analgesia was significantly shorter in groups C and D , while hypotension ( and the use of vasopressors ) was significantly higher in groups A and D. Perioperative shivering , nausea , and vomiting were significantly higher in groups A and D , while incidence of dry mouth was significantly higher in group D. Conclusions : The addition of 45 μg , 37.5 μg , and 30 μg of clonidine to hyperbaric bupivacaine results in more prolonged complete and effective analgesia , allowing reduction of up to 18 % of the total dose of hyperbaric bupivacaine . From the results of this study , 37.5 μg of clonidine seems to be the optimal dose",
"Background : Subarachnoid block is the preferred technique for providing anesthesia for patients undergoing cesarean section . Various pharmacological agents in added to local anesthetics ( LA ) modify their original effects in terms of block characteristics and quality of analgesia . However , there is ongoing debate about this practice of using adjuncts with LA . We tested whether addition of lipophilic versus lipophobic opioids to LA gives any clinical benefits to maternal and fetal outcome when used in these patients requiring spinal anesthesia . Subjects and Methods : Sixty American Society of Anesthesiologists I and II parturients , undergoing elective cesarean section requiring subarachnoid block , were included in our study . The parturients were allocated r and omly to three groups of 20 each to receive bupivacaine 12.5 mg ( Group I ) , bupivacaine 12.5 mg + morphine 0.2 mg ( Group II ) , bupivacaine 12.5 mg + fentanyl 25 μg ( Group III ) , preservative free physiological saline 0.9 % was added to all the solutions to achieve a total volume of 4 ml . The parameters studied were the time of onset , sensory level of the block achieved , total duration of analgesia , any need of rescue analgesics , maternal side effects , and fetal outcome . Results : Onset of block was early 4.30 ± 0.12 min in Group III as compared to Group I 4.64 ± 0.28 min and Group II 4.505 ± 0.22 min . Mean duration of analgesia ( hours ) was higher in Group II 15.91 ± 0.96 h as compared to Group I 1.95 ± 0.55 h and Group III 4.39 ± 0.2 h. Incidence of nausea , vomiting , and shivering was more in the control group as compared to study groups , whereas sedation and pruritus were seen more in the study groups . No adverse effects on fetus were seen with use of opioids and comparable Apgar scores were noted . Conclusion : Addition of intrthecal fentanyl causes rapid onset of block whereas intrathecal morphine provides prolonged analgesia with comparable neonatal wellbeing",
"Background and objective Shivering causes various adverse disturbances and interferes with monitoring . The optimal dose of intrathecal meperidine to prevent shivering without producing other side-effects remains unknown . This prospect i ve r and omised double-blinded study was conducted to compare the antishivering effects of two different doses of intrathecal meperidine . Methods Seventy two parturients , scheduled for elective caesarean section under spinal anaesthesia , were enrolled in three different groups . Spinal anaesthesia consisted of bupivacaine 0.5 % ( 10 mg ) for the control group ( M0 ) , and the same dose of bupivacaine with meperidine 12.5 or 25 mg for the experimental groups ( M1 , M2 ) . Blood pressure , heart rate , skin and core temperatures , sensory level , capnometry , pulse oximetry , Apgar scores , shivering intensity and intrathecal opioid-related side-effects were evaluated and recorded by a blinded observer . Data were analysed using analysis of variance , χ2 test , Kruskal – Wallis H-test and Mann – Whitney U-test . A P value less than 0.05 was considered to be significant . Results Shivering was more intense in group M0 than in groups M1 and M2 with P values of 0.003 and less than 0.001 , respectively . The intensity of shivering was comparable in groups M1 and M2 . As regards the incidence of significant shivering , it was found to be highest in M0 ( 4/24 ≈16.7 % ) in comparison with M1 ( 0/24 ) and M2 ( 0/24 ) ( P = 0.03 ) . Nausea and vomiting occurred more frequently with higher doses of meperidine ( P meperidine for caesarean section during spinal anaesthesia for the prevention of shivering can not be recommended as its use is associated with increased incidence of nausea and vomiting",
"This prospect i ve , controlled study was undertaken to determine whether addition of adrenaline or fentanyl to bupivacaine or warming of the injectate had any effect on the incidence of shivering following extradural analgesia in the labouring parturient . Eighty-four patients were sequentially allocated to four groups ( control , warm injectate , extradural adrenaline and extradural fentanyl ) . The adrenaline group had the highest incidence of shivering , the warm injectate and fentanyl groups the lowest . Extradural fentanyl also seemed promising in reducing shivering in pre-block shiverers . This paper also explores the rapidity of temperature decay of solutions of bupivacaine in different clinical situations",
"OBJECTIVE To explore the anesthetic effect and neonatal effects of dexmedetomidine combined with ropivacaine in the cesarean section under epidural anesthesia . METHODS Between January 2012 and March 2013 at the First Affiliated Hospital with Nanjing Medical University , sixty parturients with a single baby at full term in vertex presentation scheduled for caesarean section under epidural anesthesia , were r and omly divided into 3 groups ( n = 20 each ) according to the r and om digits table : dexmedetomidine + ropivacaine ( RD ) , fentanyl + ropivacaine ( RF ) and normal saline + ropivacaine ( RN ) . After identification of the epidural space and a negative aspiration test for blood or cerebrospinal fluid , 15 ml of 0.75 % ropivacaine , was administered epidurally in three the groups with addition of 1 µg/kg of dexmedetomidine in RD group , 1 µg/kg of fentanyl in RF group and 2 ml of normal saline in RN group . Recording the mean arterial pressure ( MAP ) and heat rate ( HR ) before anesthesia ( T(0 ) ) , at 10 min ( T(1 ) ) and 30 min ( T(2 ) ) after the end of epidural administration , and at end of operation ( T(3 ) ) . Recording the onset time , maximum sensory analgesic level , time to maximum sensory analgesic level , time to two segmental dermatomal regressions , and time to chief complaint of postoperative pain . The modified bromage degrees , sedation scores and traction reaction were also assessed . The Apgar scores at 1 and 5 min were also recorded after delivery , and the blood sample s were drawn from umbilical vein for gas analysis . RESULTS MAP , HR and the motor block ( Bromage scale ) were no statistics differences among the three groups ( P > 0.05 ) . Compared with RN group , the onset time and the time to maximum sensory analgesic level were significantly earlier [ ( 6.3 ± 2.4 ) , ( 8.7 ± 2.3 ) min vs ( 10.9 ± 2.7 ) min ; ( 11.5 ± 3.9 ) , ( 16.2 ± 4.6 ) min vs(19.8 ± 5.2 ) min , P 0.05 ] , the time to two segmental dermatomal regressions and the time to chief complaint of postoperative pain were prolonged significantly[(22.5 ± 4.6 ) , ( 18.5 ± 3.9 ) min vs ( 13.5 ± 3.8 ) min ; ( 415 ± 92 ) , ( 355 ± 86 ) min vs ( 273 ± 68 ) min , P were better in RD group and in RF group , and the incidence of shivering was lower in RD group ( 5 % vs 40 % , P 0.05 ) , the incidence of dizziness was higher in RF group ( 20 % vs 0 , P about the onset time , the time to maximum sensory analgesic level , the time to two segmental dermatomal regressions and the time to chief complaint of postoperative pain , and the level of sedation was better , the incidence of drowsiness was lower in RD group . There were no statistics differences about both the blood gas analysis of umbilical vein and the Apgar scores at 1 and 5 min after delivery . CONCLUSION Administration of dexmedetomidine combined with ropivacaine can provide early onset , establishment of sensory anesthesia , much better sedation levels , decrease the degree of traction reaction and the incidence of shivering , and without adverse neonatal effects ",
"BACKGROUND It is well known that intrathecal opioids have a synergic effect with spinal local anaesthetics . The aim of this study was to evaluate whether low-dose ropivacaine in combination with sufentanil could produce effective spinal anaesthesia with less maternal hypotension and vomiting than ropivacaine alone . METHODS 80 ASA I and II parturients undergoing elective caesarean delivery under combined spinal-epidural anaesthesia were r and omly allocated to two groups . Group R15 received intrathecal hyperbaric ropivacaine 15 mg and group SR10 hyperbaric ropivacaine 10 mg with sufentanil 5 micrograms . Characteristics , efficacy and side effects of spinal anaesthesia in each group were measured . RESULTS There was no significant difference in the quality of intraoperative analgesia and muscle relaxation between groups . The incidence of hypotension was significantly higher ( 55 % vs. 20 % , P need for ephedrine less in group R15 than in group SR10 . In group SR10 , the onset of motor block was delayed ( 2.9 + /- 1.1 vs. 4.6 + /- 2.5 min , P duration was shorter ( 65.9 + /- 15.1 vs. 125.4 + /- 26.4 min , P duration of effective analgesia was longer ( 260 + /- 32.5 vs. 143 + /- 22.1 min , P incidence of shivering ( 20 % vs. 60 % , P hyperbaric ropivacaine 10 mg with sufentanil 5 lg produced effective spinal anaesthesia for caesarean delivery with significantly less hypotension , vomiting and shivering , shorter duration of motor blockade and longer lasting analgesia than hyperbaric ropivacaine 15 mg",
"OBJECTIVE To determine if systematic use of metoclopramide associated with opioids ( Morphine sulfate SR ) decreases the incidence of nausea and vomiting ( N&V ) , established adverse effects of opioids . METHOD Open r and omised study with 132 patients treated for non malignant pain ( 71 women , 61 men , mean age 53.4 years ) . One group ( n = 76 ) was treated with morphine alone ; the other ( n = 56 ) with morphine plus metoclopramide . Mean duration of therapy : 6 days ; mean dosage : 60 mg/d RESULTS In the 2 groups , N&V were present in the first 72 hours . The frequency of N&V in the morphine group was 38.1 % ( conform with the literature ) . The systematic use of metoclopramide decreases the frequency of N&V : p morphine > 60 mg/d decreases N&V : p = 0.036 . High dosages of morphine can have an antiemetic effect by interaction with the mu receptors in the antiemetic center and not in the trigger zone which has an emetic effect . CONCLUSION The systematic use of metoclopramide with opioid therapy for non malignant pain in rheumatology decreases the risk of nausea and vomiting",
"Shivering associated with spinal anesthesia is uncomfortable and may interfere with monitoring . We performed this prospect i ve , double-blinded , and r and omized study to determine whether intrathecal meperidine ( 0.2 mg/kg ) decreases the incidence and intensity of shivering after spinal anesthesia for cesarean delivery . Forty parturients scheduled for nonemergent cesarean delivery were enrolled in two groups . Spinal anesthesia consisted of hyperbaric bupivacaine ( 0.75 % ; 10.5 mg ) , morphine 0.15 mg , and , in the experimental group , meperidine ( 0.2 mg/kg ) or , in the control group , normal saline . Data collection , including sensory block level , blood pressure , core temperature , and shivering intensity , was performed every minute for 10 min , every 3 min for 33 min , and then every 5 min until the sensory level receded to L4 . Time to highest sensory level , maximum number of blocked segments , sensory and motor blockade regression , and systolic blood pressure showed no difference between groups . The incidence of shivering was less ( P incidence and intensity of shivering associated with spinal anesthesia for cesarean delivery"
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41173ea8-06ff-11f0-808a-c43d1ab1c353
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This review examines the role of exercise and physical activity for preventing weight gain in older people . A structured search using MeSH-vocabulary and Title/ Abstract - search es was conducted in PubMed for January 2000 to June 2011 , identifying weight gain and exercise or physical activity as study topics , and aged adults as target group . In study selection , all types of exercise and physical activity and any measure of weight change in aged adults ( ≥65 years ) or postmenopausal women were considered . N=9 primary studies were identified . All were conducted in the US , with one study additionally including sample s from Canada and the UK . Three studies focused on aged adults , while six concentrated specifically on postmenopausal women . Forms of exercise or physical activity comprised self-reported exercise history in four studies and low , moderate or high intensity exercise interventions in five studies . Four studies combined exercise with a hypocaloric diet and included comparison groups receiving either diet only , health education , stretching or a delayed intervention ( one study each ) . Exercise was associated with weight loss ( 1.1 - 6 kg ) in all intervention studies , all of which studied an overweight sample , and with weight maintenance in most observational studies , all of which studied a general population or otherwise overweight-unspecific sample . In sum , exercise and physical activity can effectively prevent weight gain in older adults and postmenopausal women either in terms of weight loss or maintenance . They can preserve lean body mass and thus are important for the balance between potentially positive and negative effects of weight reduction in later life . In addition , since all intervention studies were conducted with an overweight sample , it seems that primordial prevention ( in terms of preventing the development of risk factors such as excess weight in the first place ) might be a neglected issue in geriatric and postmenopausal prevention
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"Objective : To estimate the excess deaths associated with weight loss in combination with leisure time physical activity among overweight or obese people . Design : Prospect i ve cohort study .Subjects : In two consecutive examinations in 1976–1978 and 1981–1983 , 11 135 people participated in the Copenhagen City Heart Study . Of these , 3078 overweight or obese participants lost weight or remained weight stable from 1976–1978 to 1981–1983 , and were without pre-existing diagnosis of diabetes , stroke , ischaemic heart disease or cancer in 1981–1983 . They were followed up until 2007 in the Danish Civil Registration System , with a body mass index ( BMI ) and physical activity in 1976–1978 and 1981–1983 and hazard ratio ( HR ) of mortality during 53 976 person-years of follow-up . Results : Of the initially overweight or obese subjects who either lost weight or remained weight stable , 2060 died . Overall , weight loss was associated with excess mortality when compared with weight stability . Weight loss was associated with a higher mortality among those who became physically inactive , compared with those who remained active while losing weight ( men : HR 2.25 , 95 % confidence interval 1.31–3.84 ; women : 1.43 , 1.07–1.91 ) . However , losing weight while remaining physically active was still associated with excess mortality when compared with those who were weight stable and initially active ( men : 1.72 , 1.27–2.34 ; women : 1.57 , 1.06–2.31 ) . Among those who remained physically inactive , weight loss seemed associated with excess mortality when compared with weight loss among those who became active , although not statistically significant ( men : 2.00 , 0.94–4.29 ; women : 1.40 , 0.82–2.39 ) . Finally , weight loss among those who became physically active was not associated with excess mortality when compared with those who were weight stable and initially inactive ( men : 1.12 , 0.61–2.07 ; women : 1.19 , 0.58–2.43 ) . Conclusion : Weight loss among the overweight or obese seemed hazardous to survival . However , weight loss seemed less hazardous to survival among those who remained physically active or those who became active",
"INTRODUCTION / PURPOSE Body weight generally increases with aging in Western societies . Although training studies show that exercise produces acute weight loss , it is unclear whether the long-term maintenance of vigorous exercise attenuates the trajectory of age-related weight gain . Specifically , prior studies have not tested whether the maintenance of physical activity , in the absence of any change in activity , prevents weight gain . METHODS Prospect i ve study of 6119 male and 2221 female runners whose running distances changed RESULTS On average , men who maintained modest ( 0 - 23 km x wk(-1 ) ) , intermediate ( 24 - 47 km x wk(-1 ) ) , or prolonged running distances ( > or = 48 km x wk(-1 ) ) all gained weight through age 64 ; however , those who maintained > or = 48 km x wk(-1 ) had one half the average annual weight gain of those who maintained ages of 35 and 44 in men and 30 and 39 yr in women , those who maintained 48 km x wk(-1 ) . Age-related weight gain , and its attenuation by maintained exercise , were both greater in younger than in older men . Men 's gains in waist circumference with age , and its attenuation by maintaining running , were the same in older and younger men . Regardless of age , women increased their body weight , waist circumference , and hip circumference over time , and these measurements were attenuated in proportion to their maintained running distance . In both sexes , running disproportionately prevented more extreme increases in weight . CONCLUSION As they aged , men and women gained less weight in proportion to their levels of sustained vigorous activity . This long-term beneficial effect is in addition to the acute weight loss that occurs with increased activity",
"OBJECTIVES In this paper , we present the results of changes in risk factors by use of hormone therapy ( HT ) at 18 months in the Women On the Move through Activity and Nutrition ( WOMAN ) r and omized trial . METHODS The trial was design ed to test the hypothesis that aggressive dietary changes and increased physical activity to reduce weight , waist circumference ( WC ) , glucose , insulin , and lipoproteins would reduce progression of sub clinical atherosclerosis , carotid intimal media thickness and plaque , coronary artery calcification , and pulse wave velocity ( PWV ) . The study focused on postmenopausal women ( n = 508 ) , mean age of 57 , who were r and omized to the Lifestyle Change ( LC ) or Health Education ( HE ) group . RESULTS At 18 months of follow-up , there was significant , 17 lb , weight loss and 10 cm WC decrease in the LC group . There were significant differences in changes in low-density lipoprotein cholesterol ( LDL-C ) , insulin , glucose , large LDL , and LDL particles between the LC and HE groups . Risk factor changes were greater for women in the LC who lost a significant amount of weight ( > or=18.8 lb ) . Participants at 18 months were subdivided into women who had stayed on HT , 125 ( 28 % ) ; stopped HT after r and omization , 145 ( 33 % ) ; and not on HT at baseline but stopped an average of 7 months prior to r and omization , 173 ( 39 % ) . Weight loss in the LC was similar for all three groups , but LDL lipoprotein response was better for women who stopped HT after r and omization or were not on HT at baseline . CONCLUSIONS The trial has been successful in increasing exercise and diet changes and reduction in weight and WC and variables related to metabolic syndrome",
"PURPOSE The study 's purpose was to investigate the relationship of sedentary ( ≤ 100 MET · min · wk(-1 ) ) , low ( > 100 - 500 MET · min · wk(-1 ) ) , moderate ( > 500 - 1200 MET · min · wk(-1 ) ) , and high ( > 1200 MET · min · wk(-1 ) ) habitual physical activity with body weight , body mass index , and measures of fat distribution ( waist-to-hip ratio ) in postmenopausal women by age decades . METHODS A prospect i ve cohort study of 58,610 postmenopausal women age 50 - 79 yr weighed annually during 8 yr at one of 40 US clinical centers was analyzed to determine the relationship of high versus low habitual physical activity with changes in body weight and fat distribution by age group . RESULTS Among women age 50 - 59 yr , there was significant weight loss in those expending > 500 - 1200 MET · min · wk(-1 ) ( coefficient = -0.30 , 95 % confidence interval = -0.53 to -0.07 ) compared with the group expending ≤ 100 MET · min · wk(-1 ) . Among women age 70 - 79 yr , higher physical activity was associated with less weight loss ( coefficient = 0.34 , 95 % confidence interval = 0.04 - 0.63 ) . Age at baseline significantly modified the association between physical activity and total weight change , whereas baseline body mass index did not . CONCLUSIONS High habitual physical activity is associated with less weight gain in younger postmenopausal women and less weight loss in older postmenopausal women . These findings suggest that promoting physical activity among postmenopausal women may be important for managing body weight changes that accompany aging",
"A Physical Activity Scale for the Elderly ( PASE ) was evaluated in a sample of community-dwelling , older adults . Respondents were r and omly assigned to complete the PASE by mail or telephone before or after a home visit assessment . Item weights for the PASE were derived by regressing a physical activity principal component score on responses to the PASE . The component score was based on 3-day motion sensor counts , a 3-day physical activity dairy and a global activity self- assessment . Test-retest reliability , assessed over a 3 - 7 week interval , was 0.75 ( 95 % CI = 0.69 - 0.80 ) . Reliability for mail administration ( r = 0.84 ) was higher than for telephone administration ( r = 0.68 ) . Construct validity was established by correlating PASE scores with health status and physiologic measures . As hypothesized , PASE scores were positively associated with grip strength ( r = 0.37 ) , static balance ( r = + 0.33 ) , leg strength ( r = 0.25 ) and negatively correlated with resting heart rate ( r = -0.13 ) , age ( r = -0.34 ) and perceived health status ( r = -0.34 ) ; and overall Sickness Impact Profile score ( r = -0.42 ) . The PASE is a brief , easily scored , reliable and valid instrument for the assessment of physical activity in epidemiologic studies of older people",
"CONTEXT The increasing prevalence of obesity is a major public health concern . Physical activity may promote weight and body fat loss . OBJECTIVE To examine the effects of exercise on total and intra-abdominal body fat overall and by level of exercise . DESIGN R and omized controlled trial conducted from 1997 to 2001 . SETTING AND PARTICIPANTS A total of 173 sedentary , overweight ( body mass index > or = 24.0 and > 33 % body fat ) , postmenopausal women aged 50 to 75 years who were living in the Seattle , Wash , area . INTERVENTION Participants were r and omly assigned to an intervention consisting of exercise facility and home-based moderate-intensity exercise ( n = 87 ) or a stretching control group ( n = 86 ) . MAIN OUTCOME MEASURE Changes in body weight and waist and hip circumferences at 3 and 12 months ; total body , intra-abdominal , and subcutaneous abdominal fat at 12 months . RESULTS Twelve-month data were available for 168 women . Women in the exercise group participated in moderate-intensity sports/recreational activity for a mean ( SD ) of 3.5 ( 1.2 ) d/wk for 176 ( 91 ) min/wk . Walking was the most frequently reported activity . Exercisers showed statistically significant differences from controls in baseline to 12-month changes in body weight ( -1.4 kg ; 95 % confidence interval [ CI ] , -2.5 to -0.3 kg ) , total body fat ( -1.0 % ; 95 % CI , -1.6 % to -0.4 % ) , intra-abdominal fat ( -8.6 g/cm2 ; 95 % CI , -17.8 to 0.9 g/cm2 ) , and subcutaneous abdominal fat ( -28.8 g/cm2 ) ; 95 % CI , -47.5 to -10.0 g/cm2 ) . A significant dose response for greater body fat loss was observed with increasing duration of exercise . CONCLUSIONS Regular exercise such as brisk walking results in reduced body weight and body fat among overweight and obese postmenopausal women",
"CONTEXT Five-year survival rates for early stage colorectal , breast , and prostate cancer currently exceed 90 % and are increasing . Cancer survivors are at greater risk for second malignancies , other comorbidities , and accelerated functional decline . Lifestyle interventions may provide benefit , but it is unknown whether long-term cancer survivors can modify their lifestyle behaviors sufficiently to improve functional status . OBJECTIVE To determine whether a telephone counseling and mailed print material -based diet and exercise intervention is effective in reorienting functional decline in older , overweight cancer survivors . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled trial of 641 overweight ( body mass index > or = 25 and or = 5 years ) survivors ( aged 65 - 91 years ) of colorectal , breast , and prostate cancer , who were r and omly assigned to an intervention group ( n = 319 ) or delayed intervention ( control ) group ( n = 322 ) in Canada , the United Kingdom , and 21 US states . Individuals were recruited for the Reach out to Enhance Wellness ( RENEW ) trial from July 1 , 2005 , through May 17 , 2007 . INTERVENTION A 12-month , home-based tailored program of telephone counseling and mailed material s promoting exercise , improved diet quality , and modest weight loss . The control group was wait-listed for 12 months . MAIN OUTCOME MEASURES Change in self-reported physical function on the Short-Form 36 physical function subscale ( score range , 0 - 100 ; a high score indicates better functioning ) from baseline to 12 months was the primary end point . Secondary outcomes included changes in function on the basic and advanced lower extremity function subscales of the Late Life Function and Disability Index ( score range , 0 - 100 ) , physical activity , body mass index , and overall health-related quality of life . RESULTS The mean baseline Short-Form 36 physical function score was 75.7 . At the 12-month follow-up , the mean function scores declined less rapidly in the intervention group ( -2.15 ; 95 % confidence interval [ CI ] , -0.36 to -3.93 ) compared with the control group ( -4.84 ; 95 % CI , -3.04 to -6.63 ) ( P = .03 ) . The mean baseline basic lower extremity function score was 78.2 . The mean changes in basic lower extremity function were 0.34 ( 95 % CI , -0.84 to 1.52 ) in the intervention group compared with -1.89 ( 95 % CI , -0.70 to -3.09 ) in the control group ( P = .005 ) . Physical activity , dietary behaviors , and overall quality of life increased significantly in the intervention group compared with the control group , and weight loss also was greater ( 2.06 kg [ 95 % CI , 1.69 to 2.43 kg ] vs 0.92 kg [ 95 % CI , 0.51 to 1.33 kg ] , respectively ; P Among older , long-term survivors of colorectal , breast , and prostate cancer , a diet and exercise intervention reduced the rate of self-reported functional decline compared with no intervention . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00303875"
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41173ee4-06ff-11f0-808a-c43d1ab1c353
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The target of diastolic blood pressure ( DBP ) remains controversial in patients with coronary artery disease ( CAD ) . We systematic ally search ed PubMed / Medline and the Cochrane Central data base for r and omized controlled trials ( RCTs ) assessing the efficacy and safety of reducing DBP in CAD patients from January 1965 to July 2017 . Seven placebo-controlled RCTs enrolling 34,814 CAD patients who achieved DBP were included in the drug-intervention group . The average achieved blood pressures ( BPs ) were 126.3/75.1 and 131.5/77.8 mmHg in the drug-intervention and placebo-control groups , respectively . Drug intervention was associated with an 11 % reduction in coronary revascularization and a 31 % reduction in heart failure . In the drug-intervention group , all-cause death , myocardial infa rct ion , angina pectoris , and stroke were reduced with marginal significance , whereas hypotension was increased by 123 % . A meta- analysis of four RCTs , in which the achieved DBP was in heart failure . These results suggest that reducing DBP to 80 mmHg or less would significantly reduce coronary revascularization and heart failure but at the expense of causing hypotension in CAD patients . Further trials are warranted to prove this issue
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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",
"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",
"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",
"BACKGROUND Our underst and ing of the growing population of very old patients ( aged > or=80 years ) with coronary artery disease and hypertension is limited , particularly the relationship between blood pressure and adverse outcomes . METHODS This was a secondary analysis of the INternational VErapamil SR-Tr and olapril STudy ( INVEST ) , which involved 22,576 clinical ly stable hypertensive coronary artery disease patients aged > or=50 years . The patients were grouped by age in 10-year increments ( aged > or=80 , n=2180 ; 70- , n=6126 ; 60- , n=7602 ; , n=6668 ) . Patients were r and omized to either verapamil SR- or atenolol-based treatment strategies , and primary outcome was first occurrence of all-cause death , nonfatal myocardial infa rct ion , or nonfatal stroke . RESULTS At baseline , increasing age was associated with higher systolic blood pressure , lower diastolic blood pressure , and wider pulse pressure ( P systolic , diastolic , and pulse pressure for each age group . However , the very old retained the widest pulse pressure and the highest proportion ( 23.6 % ) with primary outcome . The adjusted hazard ratio for primary outcomes showed a J-shaped relationship among each age group with on-treatment systolic and diastolic pressures . The systolic pressure at the hazard ratio nadir increased with increasing age , highest for the very old ( 140 mm Hg ) . However , diastolic pressure at the hazard ratio nadir was only somewhat lower for the very old ( 70 mm Hg ) . Results were independent of treatment strategy . CONCLUSION Optimal management of hypertension in very old coronary artery disease patients may involve targeting specific systolic and diastolic blood pressures that are higher and somewhat lower , respectively , compared with other age groups",
"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 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",
"ABCD : Appropriate Blood pressure Control in Diabetes ABI : ankle – brachial index ABPM : ambulatory blood pressure monitoring ACCESS : Acute C and esartan Cilexetil Therapy in Stroke Survival ACCOMPLISH : Avoiding Cardiovascular Events in Combination Therapy in Patients Living with Systolic Hypertension ACCORD : Action to Control Cardiovascular Risk in Diabetes ACE : angiotensin-converting enzyme ACTIVE I : Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events ADVANCE : Action in Diabetes and Vascular Disease : Preterax and Diamicron-MR Controlled Evaluation AHEAD : Action for HEAlth in Diabetes ALLHAT : Antihypertensive and Lipid-Lowering Treatment to Prevent Heart ATtack ALTITUDE : ALiskiren Trial In Type 2 Diabetes Using Cardio-renal Endpoints ANTIPAF : ANgioTensin II Antagonist In Paroxysmal Atrial Fibrillation APOLLO : A R and omized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People ARB : angiotensin receptor blocker ARIC : Atherosclerosis Risk In Communities ARR : aldosterone renin ratio ASCOT : Anglo-Sc and inavian Cardiac Outcomes Trial ASCOT-LLA : Anglo-Sc and inavian Cardiac Outcomes Trial — Lipid Lowering Arm ASTRAL : Angioplasty and STenting for Renal Artery Lesions A-V : atrioventricular BB : beta-blocker BMI : body mass index BP : blood pressure BSA : body surface area CA : calcium antagonist CABG : coronary artery bypass graft CAPPP : CAPtopril Prevention Project CAPRAF : C And esartan in the Prevention of Relapsing Atrial Fibrillation CHD : coronary heart disease CHHIPS : Controlling Hypertension and Hypertension Immediately Post-Stroke CKD : chronic kidney disease CKD-EPI : Chronic Kidney Disease — EPIdemiology collaboration CONVINCE : Controlled ONset Verapamil INvestigation of CV Endpoints CT : computed tomography CV : cardiovascular CVD : cardiovascular disease D : diuretic DASH : Dietary Approaches to Stop Hypertension DBP : diastolic blood pressure DCCT : Diabetes Control and Complications Study DIRECT : DIabetic REtinopathy C and esartan Trials DM : diabetes mellitus DPP-4 : dipeptidyl peptidase 4 EAS : European Atherosclerosis Society EASD : European Association for the Study of Diabetes ECG : electrocardiogram EF : ejection fraction eGFR : estimated glomerular filtration rate ELSA : European Lacidipine Study on Atherosclerosis ESC : European Society of Cardiology ESH : European Society of Hypertension ESRD : end-stage renal disease EXPLOR : Amlodipine – Valsartan Combination Decreases Central Systolic Blood Pressure more Effectively than the Amlodipine – Atenolol Combination FDA : U.S. Food and Drug Administration FEVER : Felodipine EVent Reduction study GISSI-AF : Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-Atrial Fibrillation HbA1c : glycated haemoglobin HBPM : home blood pressure monitoring HOPE : Heart Outcomes Prevention Evaluation HOT : Hypertension Optimal Treatment HRT : hormone replacement therapy HT : hypertension HYVET : HYpertension in the Very Elderly Trial IMT : intima-media thickness I-PRESERVE : Irbesartan in Heart Failure with Preserved Systolic Function INTERHEART : Effect of Potentially Modifiable Risk Factors associated with Myocardial Infa rct ion in 52 Countries INVEST : INternational VErapamil SR/T Tr and olapril ISH : Isolated systolic hypertension JNC : Joint National Committee JUPITER : Justification for the Use of Statins in Primary Prevention : an Intervention Trial Evaluating Rosuvastatin LAVi : left atrial volume index LIFE : Losartan Intervention For Endpoint Reduction in Hypertensives LV : left ventricle/left ventricular LVH : left ventricular hypertrophy LVM : left ventricular mass MDRD : Modification of Diet in Renal Disease MRFIT : Multiple Risk Factor Intervention Trial MRI : magnetic resonance imaging NORDIL : The Nordic Diltiazem Intervention study OC : oral contraceptive OD : organ damage ONTARGET : ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial PAD : peripheral artery disease PATHS : Prevention And Treatment of Hypertension Study PCI : percutaneous coronary intervention PPAR : peroxisome proliferator-activated receptor PREVEND : Prevention of REnal and Vascular ENdstage Disease PROFESS : Prevention Regimen for Effectively Avoiding Secondary Strokes PROGRESS : Perindopril Protection Against Recurrent Stroke Study PWV : pulse wave velocity QALY : Quality adjusted life years RAA : renin-angiotensin-aldosterone RAS : renin-angiotensin system RCT : r and omized controlled trials RF : risk factor ROADMAP : R and omized Olmesartan And Diabetes MicroAlbuminuria Prevention SBP : systolic blood pressure SCAST : Angiotensin-Receptor Blocker C and esartan for Treatment of Acute STroke SCOPE : Study on COgnition and Prognosis in the Elderly SCORE : Systematic COronary Risk Evaluation SHEP : Systolic Hypertension in the Elderly Program STOP : Swedish Trials in Old Patients with Hypertension STOP-2 : The second Swedish Trial in Old Patients with Hypertension SYSTCHINA : SYSTolic Hypertension in the Elderly : Chinese trial SYSTEUR : SYSTolic Hypertension in Europe TIA : transient ischaemic attack TOHP : Trials Of Hypertension Prevention TRANSCEND : Telmisartan R and omised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease UKPDS : United Kingdom Prospect i ve Diabetes Study VADT : Veterans ' Affairs Diabetes Trial VALUE : Valsartan Antihypertensive Long-term Use Evaluation WHO : World Health Organization # # # 1.1 Principles The 2013 guidelines on hypertension of the European Society of Hypertension ( ESH ) and the European Society of Cardiology",
"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"
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41173f20-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND The response of status biomarkers to an increase in iron supply depends on several physiologic and environmental factors , which make it difficult to predict the outcome of an intervention . OBJECTIVE We assessed effects of baseline iron status , sex , menopausal status , duration of intervention , iron form , and daily dose on the change in iron status in response to iron supplementation . DESIGN A systematic review of r and omized controlled trials ( RCTs ) of iron-supplementation and -fortification trials that assessed effects on hemoglobin , serum ferritin ( SF ) , soluble transferrin receptor , or body iron was conducted . Subgrouping and straight-line and curved metaregression were used to describe the magnitude and dose-responsiveness of effect modifiers with respect to changes in status . RESULTS Forty-one RCTs were included ; none of the RCTs were judged at low risk of bias . R and om-effects meta-analyses showed that iron supplementation significantly improved iron status but with high levels of heterogeneity . Metaregression explained approximately one-quarter of between- study variance in effect size . There were clear effects on SF with study duration ( increase in SF concentration/wk : 0.51 μg/L ; 95 % CI : 0.02 , 1.00 μg/L ; P = 0.04 ) and dose ( increase in SF concentration/g Fe : 0.10 μg/L ; 95 % CI : 0.01 , 0.20 μg/L ; P = 0.036 ) and on hemoglobin concentrations with baseline iron status [ -0.08 g/dL ( 95 % CI : 0.15 , 0.00 g/dL ) per 10-μg/L increase in baseline SF concentration ; P = 0.02 ] . Insufficient data were available to assess effects on body iron , sex , or menopausal status . CONCLUSION Quantitative relations between baseline iron status , study duration , and iron dose on changes in iron-status biomarkers , which were generated from the meta-analyses , can be used to predict effects of trials of iron supplementation and fortification and to design iron-intervention programs
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"In a study published elsewhere ( Wood and Elwood , 1966 ) the associations between the severity of various symptoms and haemoglobin levels in subjects who took part in a community survey is described . The present paper describes a double-blind r and omized clinical trial of the effects on these symptoms of oral iron therapy in a sample of the women seen during the community survey . In addition some limited data relating to a separate trial conducted in severely anaemic women identified in a hospital out-patient clinic are presented",
"Iron deficiency anaemia is a most common micronutrient deficiency affecting mostly the low socioeconomic population s of the developing world . The objective of this study was to evaluate the feasibility of iron fortification of household drinking water to prevent iron deficiency anaemia among members of the low socioeconomic families of Southern Brazil . A total of 21 low socioeconomic families representing 88 subjects including 1 - 6 years old children whose haemoglobin level was between 10 and 12 g/dl were selected to participate in this study . Nine families in the control group were supplied with placebo solution and 12 families in the experimental group were supplied iron solution with ascorbic acid to be added to their domestic drinking water over a period of 4 months . The feasibility and acceptability of iron fortified drinking water was assessed through home visits and question naires . Blood sample s were collected at the beginning and after 4 months of the study for the determination of haemoglobin and serum ferritin levels . The results of this study indicated that iron fortified drinking water was well received by the low socioeconomic families and that it was effective in improving the haemoglobin and serum ferritin levels . It can be concluded from this study that iron fortification of household drinking water is a simple and effective alternative for developing countries along with other technological approaches to iron fortification of foods",
"Our objective was to investigate the effects of iron depletion on adaptation to aerobic exercise , assessed by time to complete a 15-km cycle ergometer test . Forty-two iron-depleted ( serum ferritin 12 g/dl ) women ( 18 - 33 yr old ) received 100 mg of ferrous sulfate ( S ) or placebo ( P ) per day for 6 wk in a r and omized , double-blind trial . Subjects trained for 30 min/day , 5 days/wk at 75 - 85 % of maximum heart rate for the final 4 wk of the study . There were no group differences in baseline iron status or in 15-km time . Iron supplementation increased serum ferritin and decreased transferrin receptors in the S compared with the P group . The S and P groups decreased 15-km time and respiratory exchange ratio and increased work rate during the 15-km time trial after training . The decrease in 15-km time was greater in the S than in the P group ( P = 0.04 ) and could be partially attributed to increases in serum ferritin and Hb . These results indicate that iron deficiency without anemia impairs favorable adaptation to aerobic exercise ",
"BACKGROUND Results of cross-sectional studies suggest that in healthy people , iron absorption adapts to meet physiologic needs and stabilize iron stores , but this has not been adequately tested in longitudinal studies . OBJECTIVE We tested whether heme- and nonheme-iron absorption decrease in response to increased iron intake and whether iron stores reach a steady state . DESIGN In a r and omized , placebo-controlled trial , heme- and nonheme-iron absorption by healthy men and women ( n = 57 ) were measured before and after 12 wk of supplementation with 50 mg Fe/d as ferrous sulfate . Serum and fecal ferritin were measured during supplementation and for 6 mo thereafter . RESULTS Initially , both heme- and nonheme-iron absorption were inversely associated with serum ferritin concentration . Volunteers who took iron supplements , even those with serum ferritin , adapted to absorb less nonheme iron ( 3.2 % at week 12 compared with 5.0 % at week 0 , P : Serum ferritin concentration was slightly but significantly higher after iron supplementation than after placebo ( difference = 13 microg/L ) . This higher ferritin concentration persisted for > /=6 mo after supplementation , except in subjects with low iron stores , whose serum ferritin returned to baseline within 3 mo . Fecal ferritin excretion increased 2.5-fold ( P : Healthy individuals , even those with low iron stores , had reduced nonheme-iron absorption from food in response to iron supplementation . Despite this partial adaptation , iron stores were greater after iron supplementation than after placebo and this difference was sustained , except in individuals with the lowest iron stores",
"The effect of dietary factors on manganese-dependent superoxide dismutase ( MnSOD ) activity in humans has not been studied . We longitudinally evaluated changes in MnSOD activity and other indices of manganese and iron status in 47 women during a 124-d supplementation study . Subjects received one of four treatments : placebo , 60 mg iron , 15 mg manganese , or both mineral supplements daily . Manganese supplementation result ed in significant increases in lymphocyte MnSOD activity and serum manganese concentrations from baseline values but no changes in urinary manganese excretion or in any indices of iron status . Oral contraceptive use and the stage of the menstrual cycle did not confound the use of lymphocyte MnSOD activity or serum manganese to monitor manganese status , but fat intake affected both indices . This work demonstrated that lymphocyte MnSOD activity can be used with serum manganese concentrations to monitor manganese exposure in humans",
"BACKGROUND Fish sauce is consumed daily by a large proportion of the Vietnamese population and could therefore be a potentially useful food vehicle for iron-fortification programs . OBJECTIVE We evaluated the efficacy of iron-fortified fish sauce in improving the iron status of anemic women . DESIGN In a r and omized , double-masked study of 152 anemic ( hemoglobin concentration of 81 - 119 g/L ) women , a meal based on noodles or rice was served 6 d/wk with 10 mL fish sauce containing either 10 mg Fe as NaFeEDTA ( iron-fortified group ) or no added iron ( control group ) . Concentrations of hemoglobin , serum ferritin ( SF ) , and serum transferrin receptor ( TfR ) were measured at baseline and after 3 and 6 mo . RESULTS After 6 mo , hemoglobin and SF concentrations were higher and TfR concentrations were lower in the iron-fortified group than in the control group [ hemoglobin : 116.3 + /- 8.7 ( + /- SD ) compared with 107.6 + /- 11.0 g/L ( P iron deficiency ( SF 8.5 mg/L ) and iron deficiency anemia ( iron deficiency with hemoglobin iron-fortified fish sauce significantly reduced the prevalence of iron deficiency anemia in Vietnamese women during the 6-mo intervention . Fortifying fish sauce with iron by using a water-soluble , highly bioavailable compound ( NaFeEDTA ) is a promising strategy for combating iron deficiency anemia in Vietnam",
"BACKGROUND We previously showed that iron supplementation significantly improves iron status and maximal work capacity in previously untrained , marginally iron-deficient women with a baseline serum transferrin receptor concentration > 8.0 mg/L. However , the effect of transferrin receptor status on adaptation in endurance capacity after aerobic training in these subjects has not been fully explored . OBJECTIVE Our objective was to examine the effect of baseline serum transferrin receptor status on adaptations in endurance capacity . DESIGN Forty-one untrained , iron-depleted , nonanemic women were r and omly assigned to receive either 100 mg FeSO(4 ) or a placebo for 6 wk in a double-blind trial . All subjects trained on cycle ergometers 5 d/wk for the last 4 wk of the study . Endurance capacity was assessed at baseline and after treatment by using a 15-km time trial conducted on a cycle ergometer . RESULTS Significant treatment effects were observed for time to complete the 15-km time trial , work rate , and percentage of maximal oxygen uptake in subjects with a baseline serum transferrin receptor concentration > 8.0 mg/L. No significant treatment effects were observed in subjects with a normal baseline transferrin receptor concentration . CONCLUSIONS Our findings suggest that , in the presence of overt tissue iron deficiency , iron deficiency without anemia impairs adaptation in endurance capacity after aerobic training in previously untrained women . This impairment can be corrected with iron supplementation",
"It has been reported that large numbers of elderly Americans are moderately anemic because of iron deficiency anemia . In the present study , information has been obtained concerning blood composition , health , and nutritional habits of 779 people over 60 years of age , institutionalized or free-living in the Boston area . This paper presents the results of their blood examinations . Two hundred twenty-one of the free-living people examined who showed hemoglobin levels between 9 and 12.9 g/dl agreed to participate in an iron fortification study . Two-thirds of them received iron-fortified grain products daily for 6 to 8 months . The rest received the same foods without added iron . At the end of the experimental period a marked increase in hemoglobin levels averaging 1.4 g/dl was observed in both groups . This appeared to be attributable to an undefined intervention effect ; no measurable effects attributable to the iron fortification were observed . Three months of daily ferrous sulfate administration to those whose hemoglobin levels remained below 13 g/dl was without effect . Examination of the data obtained suggests that the cause of the moderately low hemoglobin levels initially observed was not occult bleeding or folic acid or iron deficiency",
"Red meat intake has been associated with increased risk of coronary heart disease and type 2 diabetes , but it remains uncertain whether these associations are causally related to unprocessed lean red meat . It has been proposed that iron derived from red meat may increase iron stores and initiate oxidative damage and inflammation . We aim ed to determine whether an increase in unprocessed lean red meat intake , partially replacing carbohydrate-rich foods , adversely influences markers of oxidative stress and inflammation . Sixty participants completed an 8-wk parallel- design ed study . They were r and omized to maintain their usual diet ( control ) or to partially replace energy from carbohydrate-rich foods with approximately 200 g/d of lean red meat ( red meat ) in isoenergetic diets . Markers of oxidative stress and inflammation were measured at baseline and at the end of intervention . Results are presented as the mean between-group difference in change and [ 95 % CI ] . Red meat , relative to control , result ed in : higher protein [ 5.3 ( 3.7 , 6.9 ) % of energy ] , lower carbohydrate [ -5.3 ( -7.9 , -2.7)% of energy ] , and higher iron [ 3.2 ( 1.1 , 5.4 ) mg/d ] intakes ; lower urinary F2-isoprostane excretion [ -137 ( -264 , -9 ) pmol/mmol creatinine ] , lower leukocyte [ -0.51 ( -0.99 , -0.02)x10(9)/L ] counts , and a trend for lower serum C-reactive protein concentrations [ -1.6 ( -3.3 , 0.0 ) mg/L , P=0.06 ] ; and no differences in concentrations of plasma F2-isoprostanes [ -12 ( -122 , 100 ) pmol/L ] , serum gamma-glytamyltransferase [ -0.8 ( -3.2 , 1.5 ) U/L ] , serum amyloid A protein [ -1.4 ( -3.4 , 0.5 ) mg/L ] , and plasma fibrinogen concentrations [ -0.08 ( -0.40 . 0.24 ) g/L ] . Our results suggest that partial replacement of dietary carbohydrate with protein from lean red meat does not elevate oxidative stress or inflammation",
"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 Tissue iron depletion may negatively affect endurance performance and muscle fatigability . OBJECTIVE We investigated tissue-level iron depletion and progressive fatigue of the quadriceps during dynamic knee-extension exercise in young women . DESIGN Twenty iron-depleted ( serum ferritin 110 g/L ) women ( macro x + /- SEM age : 29.1 + /- 1.2 y ) received iron ( iron group ) or placebo ( placebo group ) for 6 wk in a r and omized , double-blind trial ( n = 10 per group ) . A protocol integrating 2 - 3-s maximal voluntary static contractions ( MVCs ) with dynamic knee extensions was used to assess fatigue . RESULTS No significant differences between the groups in baseline iron status , MVC at rest , or MVC at the end of the protocol were observed . After treatment , serum iron and transferrin saturation increased significantly in the iron group ( P = 0.02 and P = 0.03 , respectively ) . Serum transferrin receptor concentrations increased significantly in the placebo group ( P MVC was attenuated in the iron group but not in the placebo group ( P = 0.01 ) . In the iron group , MVC at the sixth minute of the fatigue protocol and MVC at the end of the protocol were approximately 15 % ( P = 0.04 ) and approximately 27 % higher ( P iron-status indexes or tissue iron stores , although power was low ( muscle fatigability . Interpretation regarding the direct role of tissue iron status is limited by the study 's low power to detect relations between tissue iron improvement and decreased muscle fatigue",
"BACKGROUND Although elemental iron powders are widely used to fortify cereal products , little data exist on their efficacy in humans . OBJECTIVE We compared the efficacy of wheat-based snacks fortified with ferrous sulfate , electrolytic iron , or hydrogen-reduced iron in Thai women with low iron stores . DESIGN A double-blind intervention was conducted in 18 - 50-y-old women ( n = 330 ) r and omly assigned into 4 groups to receive either no fortification iron or 12 mg Fe/d for 6 d/wk for 35 wk as ferrous sulfate , electrolytic iron , or hydrogen-reduced iron in a baked , wheat-flour-based snack . Snacks were not consumed with meals , and consumption was monitored . At baseline , 20 wk , and 35 wk , hemoglobin status and iron were measured and the groups were compared . RESULTS Between baseline and 35 wk , geometric mean serum ferritin ( SF ) increased significantly in all 3 groups receiving iron ( P serum transferrin receptor ( TfR ) decreased significantly in the groups receiving ferrous sulfate and electrolytic iron ( P body iron stores increased from 1.5 + /- 2.8 to 5.4 + /- 2.9 mg/kg in the ferrous sulfate group , from 1.5 + /- 3.5 to 4.4 + /- 3.6 mg/kg in the electrolytic iron group , and from 1.3 + /- 3.2 to 3.2 + /- 4.3 mg/kg in the hydrogen-reduced iron group ( P Ferrous sulfate , electrolytic iron , and hydrogen-reduced iron , fortified into wheat-based snacks , significantly improved iron status . On the basis of the change in body iron stores during the 35-wk study , the relative efficacy of the electrolytic and hydrogen-reduced iron compared with ferrous sulfate was 77 % and 49 % , respectively",
"Forty-seven previously sedentary women participating in a 12-wk moderate aerobic-exercise program were r and omly assigned to one of four dietary groups : 50-mg/d iron supplement and a low food-iron diet ( 50 FE + EX ) , 10-mg/d iron supplement and a low food-iron diet ( 10 FE + EX ) , placebo and unrestricted diet ( P + EX ) , and meat supplement and high food-iron diet ( M + EX ) . A sedentary control group ( n = 13 ) received no dietary interventions . Hematocrit , total iron-binding capacity , and hemoglobin , serum iron , serum ferritin , and serum albumin concentrations were measured every 4 wk . Hemoglobin values decreased at the end of 4 wk in all exercising groups compared with the control group . Iron status in the 50 FE + EX and M + EX groups improved after week 4 as indicated by an increase in serum ferritin , serum iron , and hemoglobin concentrations , and a decline in total iron-binding capacity . Thus , short-term , moderate aerobic exercise result ed in compromised iron status that was offset to varying degrees by ingesting iron or meat supplements . However , meat supplements were more effective in protecting hemoglobin and ferritin status than were iron supplements",
"One cost-effective strategy for controlling iron deficiency is the fortification of staple foods or condiments with iron . We evaluated the effectiveness of fortifying fish sauce with NaFeEDTA for improving iron status in women of childbearing age in Vietnam in a double-blind intervention with r and omization by village . All families in the selected villages were supplied with fish sauce that was either unfortified ( Group C , 10 villages ) or fortified with NaFeEDTA [ 9 mmol ( 500 mg ) Fe/L , Group F , 11 villages ] for 18 mo . The effect of fortification was assessed in the 576 women ( n = 288/group ) by measuring hemoglobin and serum ferritin ( SF ) at 6 , 12 , and 18 mo . Analysis of the group x time interaction using a repeated- measures test for each response demonstrated a significant effect of fortification on hemoglobin ( P = 0.039 ) and log SF ( P prevalence of iron deficiency ( SF prevalence of anemia ( hemoglobin NaFeEDTA fortification of fish sauce is an effective method for reducing the prevalence of iron deficiency in women in Vietnam",
"Elevated iron stores may or may not promote atherogenesis by increasing free radical formation and oxidative stress , but controlled diet and supplement trials are lacking . We tested the hypothesis that iron supplementation does not increase the susceptibility of LDL to undergo oxidative modification in women with low iron status . A r and omized , double-blind , 2-period crossover study design ( n=26 ) was used to examine the effects of the following diets on measures of LDL oxidation : average American diet ( AAD ) [ 36 % of energy as fat ; 15 % saturated fatty acids ( SFA ) ] , and a Step 2 diet ( 26 % fat ; 7 % SFA ) . In addition , subjects received either a supplement containing 160 mg of ferrous sulfate ( 50 mg elemental iron ) or a placebo twice daily [ supplement group received a total of 320 mg ferrous sulfate ( 100 mg elemental iron ) daily ] . After supplementation , serum ferritin differed between the supplement and placebo groups ( P=0.008 ) . Measures of LDL oxidation were not affected by supplement intake ; however , they were affected by diet . Lag time was shorter after the women consumed the AAD diet than after the Step 2 diet ( P rate of oxidation or total dienes . Although iron status was improved by aggressive iron supplementation , LDL oxidative susceptibility was not affected . As expected , lag time was increased after the women consumed the low fat , low SFA diet . Therefore , the results of this study do not support a relationship between iron status and LDL oxidation",
"The present study investigates the prevalence and type of anaemia in Chinese female cotton mill workers . The prevalence of anaemia is reported in 447 non-pregnant female workers aged between 19 and 45 years . The mean value for haemoglobin ( Hb ) was 123 ( SD 15 ) g/l and 150 of the total 447 subjects had Hb values below 120 g/l ; thus 34 % of the population was anaemic according to World Health Organization ( WHO , 1975 ) criteria . The mean value for free erythrocyte protoporphyrin ( FEP ) was 419 ( SD 215 ) micrograms/l ; 55 % of the total population had FEP values higher than 350 micrograms/l and 72 % among the anaemic subjects . Serum ferritin ( SF ) was tested in all the women with a Hb value less than 120 g/l and 71 % of them had SF values below 12.0 micrograms/l . Eighty women diagnosed as either Fe deficient or with Fe-deficient anaemia were selected for a diagnostic supplementation trial . They were r and omly assigned to FeSO4 ( 60 or 120 mg Fe/d ) or placebo treatment for 12 weeks . Fe supplementation increased mean Hb values from 114 to 127 g/l ( P SF levels from 9.7 to 30.0 micrograms/l ( P mean FEP values from 570 to 277 micrograms/l ( P response rate of Hb in the whole Fe-treated group or Fe-treated subjects with an Hb level less than 120 g/l was 90 % or 92 % respectively . These findings indicate that the type of anaemia in this population was mainly Fe deficiency . It was also found that in this population the severity of anaemia , not the prevalence , was significantly related to the use of intra-uterine devices ( IUD )",
"This study was conducted to examine the relationship between anemia , supplementation with iron and vitamin C , and productivity . Using the cyanmethemoglobin method , 671 female garment factory workers were examined . On the basis of the World Health Organization ( WHO ) st and ard , 98 were found to be mildly or moderately/severely anemic . An equal number was r and omly chosen from the nonanemic workers . The subjects were then r and omly assigned to either the placebo group or the group receiving 525 mg of ferrous sulfate ( 105 mg elemental iron ) and 500 mg ascorbic acid . Only 118 of the 196 subjects completed the three-month study . The mean hemoglobin ( Hb ) and work output , as indicated by efficiency rating ( ER ) , of the placebo group did not change significantly . Mildly anemic workers with supplements showed a significant improvement in mean Hb , but not in mean ER . The moderately/severely anemic group receiving supplements had significant increases in both Hb and ER",
"Iron deficiency is endemic in much of the world , and food system-based approaches to eradication may be viable with new plant breeding approaches to increase the micronutrient content in staple crops . It is thought that conventional plant breeding approaches provide varieties of rice that have 400 - 500 % higher iron contents than varieties commonly consumed in much of Asia . The efficacy of consuming high-iron rice was tested during a 9-mo feeding trial with a double-blind dietary intervention in 192 religious sisters living in 10 convents around metro Manila , the Philippines . Subjects were r and omly assigned to consume either high-iron rice ( 3.21 mg/kg Fe ) or a local variety of control rice ( 0.57 mg/kg Fe ) , and daily food consumption was monitored . The high-iron rice contributed 1.79 mg Fe/d to the diet in contrast to 0.37 mg Fe/d from the control rice . The 17 % difference in total dietary iron consumption compared with controls ( 10.16 + /- 1.06 vs. 8.44 + /- 1.82 mg/d ) result ed in a modest increase in serum ferritin ( P = 0.10 ) and total body iron ( P = 0.06 ) and no increase in hemoglobin ( P = 0.59 ) . However , the response was greater in nonanemic subjects for ferritin ( P = 0.02 ) and body iron ( P = 0.05 ) , representing a 20 % increase after controlling for baseline values and daily rice consumption . The greatest improvements in iron status were seen in those nonanemic women who had the lowest baseline iron status and in those who consumed the most iron from rice . Consumption of biofortified rice , without any other changes in diet , is efficacious in improving iron stores of women with iron-poor diets in the developing world",
" In 781 female college students , there were 41 cases of iron deficiency anemia , 209 of latent iron deficiency , 3 of other anemias , and 528 normal cases . Fifty-four volunteers recruited from the iron deficiency anemia and severe latent iron deficiency groups were r and omly divided into 4 study groups . Groups I and III received 500 mg of vitamin C daily , and groups II and IV received ferric ammonium citrate ( FeAC ; equivalent to 6 mg iron ) in addition to vitamin C for 9 weeks . Groups I and II were loaded by aerobic exercise at 50 % VO2 max . Significant differences between groups were noted in serum ferritin ( SF ) in III/IV , hematocrit ( Ht ) in II/III and III/IV , and reticulocytes ( RET ) in I/II , I/IV , and III/IV . Hemoglobin ( Hb ) and other iron-related blood indices tended to normalize in groups II and IV when compared with the pre-values . VO2 max was elevated in groups I and II regardless of iron treatment , but was augmented more in group II than group",
"BACKGROUND No treatment is known to permanently increase salivary flow in patients with hyposalivation . The objective of this study was to investigate the effect of iron supplementation on salivary flow rate . METHODS A double-blind , r and omized , placebo-controlled trial was carried out on 50 individuals with a low unstimulated whole salivary flow rate and low serum ferritin . Half the individuals received 60 mg iron orally twice a day for 3 months , while the other half received placebo . RESULTS No statistically significant difference was found between the groups after treatment for the unstimulated flow rate and in the subjective assessment s of oral dryness . The serum ferritin values increased significantly in the iron group but not in the placebo group . CONCLUSION Oral supplementation with iron for 3 months has no effect on salivary flow rate among individuals with hyposalivation and low serum ferritin values",
"BACKGROUND Iron status de grade s in female soldiers during military training . Inflammation-mediated up-regulation of hepcidin , a key mediator of iron homeostasis , may be a contributing factor . OBJECTIVE We measured the efficacy of an iron-fortified food product for maintaining iron status in female soldiers during basic combat training ( BCT ) and examined relations between iron status , serum hepcidin concentrations , and inflammation . DESIGN A r and omized , double-blind , placebo-controlled trial was conducted . Volunteers received an iron-fortified food product ( total dose = 56 mg Fe/d ) or a placebo twice daily during the 9-wk BCT course . Iron-status indicators , serum hepcidin concentrations , and markers of inflammation were measured pre- and post-BCT . RESULTS BCT affected iron status ; serum ferritin concentrations decreased ( P concentrations of soluble transferrin receptor ( sTfR ) and hemoglobin and the red cell distribution width increased ( P iron-fortified food product attenuated declines in iron status in iron-deficient anemic soldiers ; a group-by-time interaction was observed for hemoglobin and sTfR concentrations ( P Serum hepcidin concentrations were not affected by BCT ; however , hepcidin concentrations were lower in iron-deficient anemic soldiers than in those with normal iron status ( P serum ferritin ( P C-reactive protein ( P iron-fortified food product improved iron status in iron-deficient anemic soldiers but not in iron-normal or iron-deficient nonanemic soldiers . Serum hepcidin concentrations were not affected by training but were associated with iron status and inflammation pre- and post-BCT . This trial was registered at clinical trials.gov as NCT01100905",
"The effects of iron-deficiency anaemia on workers productivity were studied in a tea plantation in Sri Lanka . The quantity of tea picked per day was studied before and after iron supplementation or placebo treatment . After one month 's treatment significantly more tea was picked when the haemoglobin ( Hb ) concentration was increased by iron supplementation than when it was not . The degree of improvement was greater in more-anaemic subjects ( those with concentrations of 6.0 - 9.0 g Hb/dl ) . The level of physical activity of anaemic subjects in their everyday environment was also recorded for four or 24 hours continuously both before and after treatment . After three weeks these levels was significantly greater in the iron-treated than matched placebo-treated subjects . The economic implication s of increased work productively with iron treatment are evident , particularly in developing countries . These results also provide strong evidence for the clinical impression that people with iron-deficiency anaemia suffer from tiredness and weakness",
"Fe-deficiency anaemia is a worldwide health problem . We studied the influence of consuming an Fe-fortified fruit juice on Fe status in menstruating women . A r and omised , double-blind , placebo-controlled study of 16 weeks of duration was performed . Subjects were r and omised into two groups : the P group ( n 58 ) or the F group ( n 64 ) , and consumed , as a supplement to their usual diet , 500 ml/d of a placebo fruit juice or an Fe-fortified fruit juice , respectively . The Fe-fortified fruit juice , containing microencapsulated iron pyrophosphate , provided 18 mg Fe/d ( 100 % of the RDA ) . At baseline and monthly , dietary intake , body weight and Fe parameters were determined : total erythrocytes , haematocrit , mean corpuscular volume ( MCV ) , red blood cell distribution width ( RDW ) , Hb , serum Fe , serum ferritin , serum transferrin , transferrin saturation , soluble transferrin receptor ( sTfR ) and zinc protoporphyrin ( ZnPP ) . The fruit juice consumption involved increased intake of carbohydrates and vitamin C , and increased BMI within normal limits . Ferritin was higher in the F group after week 4 ( P ( P was higher at weeks 4 and 8 in the F group compared with the P group ( P increased after week 8 , and haematocrit , MCV and Hb increased after week 12 , in the F group compared with the P group . Serum Fe did not change . sTfR and ZnPP decreased in the F group at week 16 ( P improves Fe status and may be used to prevent Fe-deficiency anaemia",
"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",
"Seven hundred seventeen healthy male blood donors regularly donating four or more units a year were surveyed for haemoglobin and serum ferritin levels . One hundred fiftyone ( 21 % ) had a haemoglobin less than 13.5 g/dl and were therefore disqualified from further blood donation , having a mean serum ferritin of 28 μg/liter . Of the remaining 566 donors with haemoglobin levels equal to or greater than 13.5 g/dl , the mean serum ferritin was 33 μg/liter , although in 299 ( 53 % ) the value was less than 28 μg/liter . To document response to iron therapy 46 donors with haemoglobin levels equal to or greater than 13.5 g/dl were stratified into those with the lowest iron stores ( group 1 ; n = 23 ) , defined as a serum ferritin less than 20 μg/liter , and controls ( group 2 ; n = 23 ) , with serum ferritin between 50 and 150 μg/liter . Within each stratum donors r and omly received ferric polymaltose at a dose of 100 mg elemental iron twice daily for 56 days ( groups 1a and 2a ) or an identical iron‐free placebo tablet administered on the same schedule ( groups 1b and 2b ) . Iron therapy in the iron‐deficient group ( group 1a : n = 11 ) result ed in a significant rise in haemoglobin ( p = .03 ) and iron stores reflected in serum ferritin ( p = .002 ) compared to those receiving placebo ( group 1b ) . In the control group iron therapy or placebo was without significant effect . Thus , ferric polymaltose preparation is bioavailable and is notable for the virtual absence of gastrointestinal tract side effects",
"Background Universal fortification of staple foods with iron has been widely promoted as a cost-effective strategy to reduce iron deficiency in developing-country population s. Nonetheless , relatively few efficacy trials have been reported to date to demonstrate impact on iron status . The Ultra Rice technology provides a means of delivering fortificant iron via rice . Objective The objective of this study was to test the efficacy of rice fortified with microencapsulated , micronized iron pyrophosphate to improve the iron status of women in Mexico in a r and omized , controlled intervention trial . Methods Nonpregnant , nonlactating women 18 to 49 years of age were recruited from six factories . The women received a daily portion of cooked rice 5 days per week for a period of 6 months , before and after which iron status indicators were determined in venous blood sample s. Results The average intake of iron from the fortificant was 13 mg/day . Mean plasma ferritin concentration and estimated body iron stores were significantly higher , and transferrin receptors were lower , in the iron-fortified rice group following the intervention . Mean hemoglobin concentration also increased in the treatment group , but the increase was significant only when the analysis was restricted to those with baseline hemoglobin anemia and iron deficiency was 10.3 and 15.1 percentage points , respectively . Total iron intake from fortificant was a significant covariate of change in body iron stores . The overall prevalence of anemia was reduced by 80 % . Conclusions Fortification of rice with iron using this technology is an efficacious strategy for preventing iron deficiency",
"Objective : To determine the effect of iron supplementation on iron status and endurance capacity . Design : R and omized , double-blind iron supplementation . Setting : University of Missouri-Columbia and surrounding community . Subjects : Twenty iron-deficient ( serum ferritin , sFer8.0 mg/l ; or sTfR/log sFer index > 4.5 ) , nonanemic ( hemoglobin , Hb>120 g/l , women ; > 130 g/l , men ) men and women ( 18–41 years ) were recruited via fliers and newspaper advertisements ; 20 of 31 eligible subjects participated . Interventions : A 30 mg measure of elemental iron as ferrous sulfate or placebo daily for 6 weeks . Results : Dietary iron intake and physical activity did not differ between groups before or after supplementation . Iron supplementation significantly increased sFer compared to placebo ( P=0.01 ) , but did not affect Hb or hematocrit . Iron supplementation prevented the decline in ventilatory threshold ( VT ) observed in the placebo group from pre- to post-supplementation ( P=0.01 ) ; this effect was greater in individuals with lower sFer before intervention ( P . Changes in sFer from pre- to post-treatment were positively correlated with changes in VT ( P=0.03 ) , independent of supplementation . The iron group significantly increased gross energetic efficiency during the submaximal test ( P=0.04 ) . Changes in sFer were negatively correlated with changes in average respiratory exchange ratio during the submaximal test ( P Conclusions : Iron supplementation significantly improves iron status and endurance capacity in iron-deficient , nonanemic trained male and female subjects . Sponsorship : Missouri University Alumni Association , by the Elizabeth Hegarty Foundation and by the Department of Nutritional Sciences",
"Adverse sensory changes prevent the addition of highly bioavailable ferrous sulfate ( FeSO4 ) to most wheat flours . Poorly absorbable reduced Fe powders are commonly used . Encapsulation of FeSO4 can overcome these sensory changes , but the particle size of commercial compounds is too large to be used by flour mills . The first objective of the study was to measure the efficacy in wheat flour of two newly developed Fe compounds , an H-reduced Fe powder ( NutraFine RS ; North America Höganäs High Alloys LLC , Johnstown , PA , USA ) and small particle-sized ( 40 microm ) encapsulated FeSO4 . As a second objective , the microcapsules were evaluated as a vehicle for iodine fortification . A r and omised , double-blind controlled intervention trial was conducted in Kuwaiti women ( n 279 ; aged 18 - 35 years ) with low body Fe stores ( serum ferritin ( SF ) assigned to one of three groups ( 20 mg Fe as NutraFine RS , 10 mg Fe as encapsulated FeSO4 and 150 microg iodine , or no fortification Fe ) who consumed wheat-based biscuits 5 d per week . At baseline and 22 weeks , Hb , SF , transferrin receptor , urinary iodine and body Fe stores were measured . Relative to control , mean SF in the encapsulated FeSO4 group increased by 88 % ( P body Fe stores increased from - 0.96 to 2.24 mg/kg body weight ( P increase SF or body Fe stores . The median urinary iodine concentration increased from 140 to 213 microg/l ( P efficacious in improving Fe status . The newly developed microcapsules were highly efficacious in improving both Fe stores and iodine status",
"Serum transferrin receptor ( sTfR ) concentration has been recognized recently as a reliable indicator of functional iron deficiency , but its response to iron supplementation has not been investigated in marginally iron-deficient women . In this r and omized , double-blinded trial , 37 female subjects aged 19 - 35 y with iron depletion without anemia ( hemoglobin > 120 g/L and serum ferritin received an iron supplement or placebo for 8 wk . Iron status was measured before treatment , after 4 wk of treatment , and posttreatment ( ie , after 8 wk of treatment ) . Iron supplementation of these iron-depleted , nonanemic women result ed in a progressive and significant decrease in sTfR and a significant increase in serum ferritin , and prevented a fall in hemoglobin . The responsiveness of sTfR to iron treatment indicated that sTfR is a sensitive indicator of marginal iron deficiency in iron-depleted , nonanemic women , even when their body iron stores were being replenished",
"BACKGROUND AND PURPOSE Restless Legs Syndrome ( RLS ) is a primary disorder of sensation that affects sleep and has been associated with iron deficiency . The purpose of this study was to determine if symptomatic RLS patients with low-normal serum ferritin levels benefit from oral iron replacement . PATIENTS AND METHODS This was a r and omized , placebo-controlled , double-blinded study . Eligible patients were r and omized to oral iron therapy vs. appearance-matched placebo and followed over a 12 week period . RESULTS Baseline International Restless Leg Scale ( IRLS ) scores for the treatment ( 24.8+/-5.72 ) and placebo ( 23.0+/-5.03 ) groups were similar . Baseline ferritin levels for the treatment ( 40.6+/-15.3ng/ml ) and placebo ( 36.7+/-20.8ng/ml ) groups were also similar . After 12 weeks , IRLS scores decreased more in the treatment arm ( 10.3+/-7.40 ) than in the placebo arm ( 1.14+/-5.64 ) , ( p=0.01 ) . Ferritin levels increased more in the treatment arm ( 25.1+/-20.3ng/ml ) than in the placebo arm ( 7.5+/-13.7ng/ml ) , ( p=0.04 ) . We observed a nonsignificant trend toward improved quality of life in the treated patients , ( p=0.07 ) . CONCLUSIONS This is the first double-blinded , placebo-controlled study to demonstrate statistically significant improvement in RLS symptoms using oral iron therapy in patients with low-normal ferritin . The findings from this study suggest that additional larger r and omized placebo-controlled trials of iron as treatment for patients with low-normal ferritin are warranted",
"Objective : To investigate the efficacy of , first , a dietary regimen involving increased consumption of iron-rich foods and enhancers of iron absorption and decreased consumption of inhibitors of iron absorption and , second , a low dose iron chelate iron supplement , for increasing iron stores in young adult New Zeal and women with mild iron deficiency ( MID ) . Methods : The study was a 16 week r and omized placebo-controlled intervention . Seventy-five women aged 18 to 40 years with MID ( serum ferritin were assigned to one of three groups : Placebo , Supplement ( 50 mg iron/day as amino acid chelate ) or Diet . Participants in the Diet Group were given individual dietary counseling to increase the intake and bioavailability of dietary iron . Dietary changes were monitored by a previously vali date d computer-administered iron food frequency question naire . Results : Diet Group members significantly increased their intake of flesh foods , heme iron , vitamin C and foods cooked using cast-iron cookware and significantly decreased their phytate and calcium intakes . Serum ferritin increased in the Supplement and Diet Groups by 59 % ( p=0.001 ) and 26 % ( p=0.068 ) , respectively , in comparison to the Placebo Group . The serum transferrin receptor : serum ferritin ratio decreased by 51 % in the Supplement Group ( p=0.0001 ) , and there was a non-significant decrease of 22 % ( p=0.1232 ) in the Diet Group . Conclusions : This study is the first , to our knowledge , to demonstrate that an intensive dietary program has the potential to improve the iron status of women with iron deficiency",
"BACKGROUND Decrements in iron status have been reported in female soldiers during military training . Diminished iron status adversely affects physical and cognitive performance . OBJECTIVE We wanted to determine whether iron supplementation could prevent decrements in iron status and improve measures of physical performance and cognitive status in female soldiers during basic combat training ( BCT ) . DESIGN In this 8-wk r and omized , double-blind , placebo-controlled trial , soldier volunteers ( n = 219 ) were provided with capsules containing either 100 mg ferrous sulfate or a placebo . Iron status indicator assays were performed pre- and post-BCT . Two-mile running time was assessed post-BCT ; mood was assessed by using the Profile of Mood States question naire pre- and post-BCT . RESULTS The BCT course affected iron status : red blood cell distribution width and soluble transferrin receptor were elevated ( P serum ferritin was lowered ( P iron status ; group-by-time interactions ( P serum ferritin and soluble transferrin receptor . Iron supplementation result ed in improved ( P vigor scores on the Profile of Mood States post-BCT and in faster running time ( P iron status in female soldiers . Furthermore , iron supplementation may prove to be beneficial for mood and physical performance during the training period . Future efforts should identify and treat female soldiers or athletes who begin training regimens with iron deficiency or iron deficiency anemia",
"Abstract In many countries an attempt is made at a national level to prevent iron deficiency by enriching food with iron . The amount by which iron intake should be increased is unknown , and decisions seem to be based on very inadequate evidence . Trials of iron supplements in two at-risk groups revealed an effect on haemoglobin level of a supplement of 10 mg . iron per day , but gave no clear evidence of an effect of a smaller supplement",
"There was no significant change in the maximal oxygen uptake for either the experimental or the control group from the pre-test to the post-test . Five blood chemistry measures were unable to predict the post-maximal oxygen uptake scores using the procedure of stepwise regression . An examination of the blood chemistry profiles indicated that sports anemia did not occur . The factorial breakdown was unable to produce any significant insight into the changes in hemoglobin concentration and oxygen consumption . Heme-iron supplementation was unable to override the regulatory system of the body and allow the hemoglobin level to become elevated",
"We studied effects of dose and treatment duration during low-dose iron supplementation in premenopausal , non-pregnant women , with initial serum ferritin and haemoglobin concentrations or = 120 g x l-1 , respectively . The study was r and omized , double-blind and placebo-controlled . Three groups completed a 6-month study : placebo ( n = 27 ) , FE-9 ( 9 mg iron x day-1 , n = 18 ) and FE-27 group ( 27 mg iron x day-1 , n = 19 ) . The supplement consisted of 11 % heme and 89 % inorganic iron . In FE-27 , serum ferritin increased from ( mean , 95 % confidence interval ) 11.8 ( 9.7 ; 14.4 ) to 25.3 ( 18.6 ; 34.4 ) micrograms x l-1 in 1 month , and remained stable after that ( ANOVA : group effect , P = 0.0003 ) . In both FE-9 and FE-27 , blood haemoglobin levels increased from 136 ( 132 ; 140 ) to 142 ( 139 ; 145 ) g x l-1 in 1 month , remaining constant after that ( group effect , P = 0.001 ) . Hence , the 27 mg daily dose of organic/inorganic iron corrected both mild anaemia and storage iron depletion , whereas the 9 mg dose did not affect iron stores . Elongation of treatment duration above 1 month brought about only minor changes",
"In a double-blind trial the response to treatment with Ferro-Gradume ( a slow-release preparation of ferrous sulphate ) has been compared in the same individuals with the response to ferrous fumarate in a single daily dose regimen using a similar dose of iron . No significant difference was found in the therapeutic response or in the incidence of side-effects between the two preparations",
"1 . Two large-scale community based studies of the haematinic effect of iron added to flour used to bake bread are reported . These were design ed to simulate conditions in the community as closely as possible . 2 . Neither trial gave conclusive evidence of benefit in terms of an effect on circulating haemoglobin level , but in one trial the results suggested a small haematinic effect . 3 . The availability of an iron salt from bread eaten in a normal varied diet is clearly much lower than has been suggested from highly controlled radioactive isotope studies",
"The impact of long-term ( 6-month ) moderate exercise on the iron status of previously sedentary women was determined by r and omly assigning 62 college-age women into one of the following four groups : 1 ) 50 mg.d-1 iron supplement , low iron diet ( N = 16 ) ; 2 ) Placebo , free choice diet ( N = 13 ) ; 3 ) Meat supplement to achieve 15 mg.d-1 iron intake ( N = 13 ) ; and 4 ) Control , free choice diet ( N = 20 ) . All groups except the Control group exercised 3 d.wk-1 at 60%-75 % of their heart rate reserve . VO2max was measured at baseline and week 24 . Blood was sample d at baseline and every 4 wk thereafter for 24 wk to measure iron status and to eluci date the causes for alterations in iron status . Subjects had depleted iron stores throughout the study as indicated by their serum ferritin levels ( Serum iron , total iron binding capacity and transferrin saturation were not compromised with exercise . Mean hemoglobin level in the Placebo/Ex group was significantly ( P serum albumin , haptoglobin , and erythropoietin data from the study can not explain these changes",
"BACKGROUND Reduced salivary flow is a condition that affects oral health . Its prevalence is unknown in young and middle-aged adults and there is no known treatment that permanently increases the salivary flow rate . Reduced salivary flow is related to dental caries , the most common oral disease . Reduced salivary flow is often found in individuals with insufficient food intake and thereby insufficient nutrition to the salivary gl and s. One nutrition related factor that has been proposed to effect salivary flow rate is iron deficiency . AIMS The aims of the thesis were to investigate i ) the prevalence of reduced salivary flow rate in different age groups of adults , ii ) the relationship between reduced salivary flow rate , general health and dental caries , iii ) the influence of time of measurement on reduced salivary flow rate , and iv ) if reduced salivary flow rates could be increased by iron supplementation . MATERIAL AND METHODS In Study I saliva was collected from 1427 individuals aged 20 - 69 years . A question naire was answered regarding subjective oral dryness , general diseases , use of drugs , BMI ( Body Mass Index ) and use of tobacco . In Study II saliva was collected from 48 patients with active caries and 48 caries-inactive patients . A blood sample was analysed for serum ferritin . In Study III the unstimulated salivary flow rate was tested at 7:30 and 11:30 a.m. in 108 individuals , age 15 - 46 years . The participants were allocated to one of three groups ( very low 0.2 mL/min ) based on the the unstimulated salivary flow rate at 7:30 a.m. Different aspects of the perception of oral dryness were rated using Visual Analogue Scales . In Study IV a double-blind , r and omized controlled trial was carried out on 50 individuals with a low unstimulated whole salivary flow rate and low serum ferritin . Half the individuals received 60 mg of iron orally twice a day for 3 months , while the other half received placebo . RESULTS In Study I it was found that the prevalence of very low ( and low ( 0.10 - 0.19 mL/min ) unstimulated salivary flow rate were similar for different age groups up to 50 years , ranging between 10.9 - 17.8 % and 17.3 - 22.7 % , respectively . Multiple logistic regression revealed that above age 50 , female gender , ' having fewer than 20 teeth ' , and taking xerogenic drugs significantly increased the risk of very low unstimulated salivary flow rate . In Study II 32 individuals ( 67 % ) in the caries active group had low unstimulated salivary flow rate compared with 13 individuals ( 27 % ) in the caries inactive group . There was no difference in serum ferritin levels between the two groups . Study III showed for all groups a statistically significant increase in unstimulated salivary flow rate at 11:30 a.m. compared with 7:30 a.m. , all of similar magnitude ( 0.08 - 0.09 mL/min ) . In the group with very low salivary flow rate , 70 % at 11:30 a.m. exceeded the 0.1 mL/min limit . There were significant difference in perception of oral dryness between the normal group and both the low and the very low groups . In Study IV no statistically significant difference was found between the groups after treatment for the unstimulated flow rate and in the subjective assessment s of oral dryness . CONCLUSIONS The prevalence of reduced salivary flow rates is consistent and prevalent in younger and middle-aged adults ( Very low salivary flow rates are related to high Body Mass Index ( BMI ) and diagnosed diseases in younger adults , but to medication in older adults . Reduced salivary flow rate in young adult women is related to caries . The time of measurement of salivary flow rates influences diagnosis of hyposalivation . Iron supplementation does not enhance salivary flow",
". The effect of a high oral iron supplementation ( 120 mg day ) on the physical work capacity has been studied in a group of apparently healthy men and women of ages 58–71 years , and this effect was correlated with the initial values of and changes in some variables constituting usual clinical estimates of the state of iron nutrition . The increase in physical work capacity was about 4 % higher in men and about 12 % higher in women in the group supplemented with iron than in the control ( placebo ) group . In the control group there was a positive correlation between increase in physical work capacity and initial value for stainable iron in the bone marrow , and a negative correlation between increase in physical work capacity and decrease in the value for stainable iron in the bone marrow ; it is pointed out that these findings should not be expected in the iron-supplemented group , where variations in the depot iron will be of less influence . In the iron-supplemented group the total iron binding capacity decreased significantly , while the remaining variables constituting estimates of the state of iron nutrition showed no significant changes . The increase in physical work capacity in the iron-supplemented group did not appear to be correlated to the initial value either for haemoglobin concentration or for other variables estimating the state of iron nutrition . It is concluded that in apparently healthy people the increase in physical work capacity during moderate training is related to the availability of iron",
"PURPOSE : There is increasing evidence that screening for colorectal cancer may save lives , and consequently , both professional and public interest in screening for colorectal cancer is increasing . As yet , however , there is no perfect screening test . Insidious blood loss is a common feature of colorectal cancer and may lead to a fall in serum ferritin before the patient becomes anemic . Measurement of serum ferritin , which is widely available and easily and inexpensively performed , has , therefore , been postulated as a potential screening test for colorectal cancer . METHOD : This study used sample s of serum collected from 148 patients recruited to a screening study for colorectal cancer . All patients were thoroughly investigated by double-contrast barium enema and /or colonoscopy . Patients were selected r and omly from each of three clinical diagnostic groups : 50 patients with proven colorectal cancer , 49 patients without colon disease , and patients with adenomas of the colon . Serum ferritin was assayed by immunoradiometry . The expected adult reference range is 25 to 350 µg/l , and results were reported without patient identification . RESULTS : There were no significant differences in serum ferritin levels among any of the three groups . CONCLUSION : Serum ferritin is unlikely to be of value as a screening test for colorectal cancer",
"BACKGROUND R and om serial sampling is widely used in population pharmacokinetic studies and may have advantages compared with conventional fixed time-point evaluation of iron fortification . OBJECTIVE Our objective was to vali date r and om serial sampling to judge the efficacy of iron fortification of a low-fat margarine . DESIGN We conducted a 32-wk placebo-controlled , double-blind , iron-intervention trial in 18 - 40-y-old Swiss women ( n = 142 ) with serum ferritin ( SF ) concentrations Women were r and omly assigned to 3 groups to receive 20 g margarine , with 14 mg added iron as either micronized ground ferric pyrophosphate ( MGFePP ) or sodium iron edetate ( NaFeEDTA ) , or placebo daily . We measured hemoglobin and iron status of subjects at 2 fixed time points ( at baseline and the endpoint ) plus 3 r and omly assigned time points between 4 and 28 wk . With the use of bootstrapping , the number of observations per individual was reduced to 3 and then compared with the 5-time-point data . Mixed-effects models were used to estimate iron repletion over time for r and om sampling , and analysis of covariance was used for fixed time-point sampling . RESULTS Body iron stores increased in women who received MGFePP or NaFeEDTA compared with women who received placebo ( P increase in body iron stores with NaFeEDTA fortification was 2 - 3 times the increase with MGFePP fortification ( P < 0.05 ) ; the difference was more marked in women with baseline SF concentrations < 15 μg/L ( P < 0.05 ) . R and om serial sampling reduced the required sample size per group to one-tenth of that for 2 fixed time points . Compared with the 5-time-point analysis , the 3-time-point sparse sampling generated comparable estimates of efficacy . CONCLUSIONS When used to evaluate the efficacy of iron fortificants , r and om serial sampling can reduce the sample size , invasiveness , and costs while increasing sensitivity . R and om serial sampling more clearly describes the pattern of iron repletion and may prove useful in evaluating other micronutrient interventions"
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41173f66-06ff-11f0-808a-c43d1ab1c353
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Bathing in water ( balneotherapy or spa therapy ) has been frequently and widely used in classical medicine as a cure for diseases . This paper review s the present literature on the use of balneotherapy in dermatologic , chronic musculoskeletal ( inflammatory and non-inflammatory ) , metabolic and psychological conditions . We performed a systematic review on related papers appearing in the Medline and Cochrane Library data base from 1966 to 2003 that included r and omized controlled and non-r and omized clinical trials using balneotherapy . We also determined to reflect where possible the chemical compositions of spas . The major dermatologic and musculoskeletal diseases that are frequently treated by balneotherapy with a remarkable rate of success are atopic dermatitis , psoriasis , rheumatoid arthritis ( RA ) , ankylosing spondylitis , osteoarthritis and low back pain . Moreover , the effects of spa therapy on several metabolic conditions are discussed . The mechanisms by which broad spectrums of diseases respond to spa therapy probably incorporate chemical , thermal and mechanical effects . The importance of balneotherapy either alone or as complement to other therapies should be considered after , or accompanying , orthodox medical treatments
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[
"BACKGROUND Plasma homocysteine ( tHcy ) is a risk factor for cardio-vascular diseases . Furthermore it has been associated with antioxidative status . Additionally balneotherapeutic sulphur baths have been shown to influence antioxidative status . METHODS 40 patients with degenerative osteoarthrosis were r and omised into two equal groups , a treatment group , receiving stationary spa therapy plus daily sulphur baths ( sulphur group ) and a control group receiving spa therapy alone ( control group ) . Blood tHcy levels and urinary 8-OHdG ( an indicator for oxidative stress ) were measured at the beginning and the end of spa therapy . RESULTS tHcy ( micromol/l ) was significantly reduced from 11.41 ( + /-2.91 ) to 10.55 ( + /-2.28 ) in the sulphur group ( p=0.016 ) and rose insignificantly from 12.93 ( + /-2.28 ) to 13.80 ( + /-3.87 ) in the control group . 8-OHdG ( ng 8-OHdG/mg creatinine ) declined from 18.00 ( + /-18.28 ) to 11.16 ( + /-5.33 ) in the sulphur group ( n.s . ) and from 17.91 ( + /-5.87 ) to 18.17 ( + /-5.70 ) in the control group ( n.s . ) . Differences between the two groups showed significant effects of sulphur baths for tHcy ( p=0.006 ) but not for 8-OHdG ( p=0.106 ) . CONCLUSIONS Sulphur baths exert beneficial effects on plasma tHcyt whereas effects on 8-OHdG seem to be unlikely",
"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",
"OBJECTIVE To assess the overall effectiveness of spa therapy compared with usual routine drug therapy in chronic low back pain ( LBP ) . METHODS One hundred and twenty-one patients were r and omly allocated to treatment ( n = 59 ) and control ( n = 62 ) groups . In the treatment group , patients underwent routine drug therapy and spa therapy 6 days/week for 3 consecutive weeks in Saint-Nectaire , France . In the control group , patients received routine drug therapy . Effectiveness was assessed based on clinical measures , duration and intensity of pain , Rol and and Morris ' disability question naire , the patient 's overall evaluation of back health , and drug consumption ( analgesic and antiinflammatory ) . Groups were compared using analysis of covariance with repeated measures . RESULTS At 3 weeks , patients in the treatment group had significant improvement in all outcome variables ( p Schober index and analgesic and antiinflammatory drug consumption . At 6 months , improvement was still significant for the same outcome variables ( p significant reduction in analgesic consumption . CONCLUSION This study suggests both immediate and 6 month effectiveness of spa therapy in chronic LBP . Spa therapy may be beneficial in the management of chronic LBP",
"The effects of immersion of the lower leg and foot in fresh water and in carbon dioxide ( CO2 ) -enriched water ( 1200 mg CO2 per kg water ; succinate + sodium bicarbonate : Actibath ® , KAO Tokyo ) on cutaneous circulation , vasomotion and oxygen tension ( PO2 ) were measured by laser Doppler flowmetry and transcutaneous oximetry . On the first of two consecutive days patients were r and omly assigned to have the lower extremities immersed in either fresh water or CO2-enriched water under st and ardized conditions ( temperature , 34 ° C ; depth , 35 cm ; immersion time , twenty minutes ) with concurrent measurement . On the second day patients were switched to the other bath type . For both sets of measurements probes were attached symmetrically to the dorsum of each foot . Included in the study were 18 patients with mild , bilateral , peripheral , occlusive arterial disease ( intermittent claudication , femoral or iliac type ) . During immersion in CO2 enriched water the Doppler laser signal and vasomotion amplitude rose by 300 % , while PO2 increased by 10 % . These increases were still apparent during the latter part of the measurement period , following withdrawal of the limbs from the bath , while patients were seated and supine . During immersion in fresh water and thereafter the Doppler laser signal was unchanged and the PO2 increase was considerably less marked . The authors were thus able to demonstrate vasodilation and increased oxygen utilization ( Bohr effect ) result ing from topical CO2 application , and hence , that the use of topical CO2 has an objective basis",
"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",
"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",
"BACKGROUND The aim of this study was to evaluate the efficacy and tolerability of vaginal irrigations with arsenical-ferruginose water from the spa at Terme di Levico in chronic cervico-vaginitis in order to assess the validity of balneotherapy in improving the symptoms and quality of life of patients . METHODS An open comparative study was performed in 30 patients with symptoms attributable to aspecific chronic vaginitis ( in child-bearing age ) or vulvovaginal dystrophy ( perimenopausal age ) . Twenty patients ( Group A ) received balneotherapy and 10 ( Group B ) were treated with placebo vaginal suppositories . All patients were required to fill in a question naire on symptoms . A thorough gynecological examination was performed , together with a Pap-test and vaginal secretion sample for bacterioscopic and microbiological tests . The same tests were repeated at the end of treatment . RESULTS Post-treatment results showed a general reduction in the extent of gynecological symptoms reported by patients . A statistically significant reduction was only observed in patients receiving balneotherapy for the following symptoms : vaginal burning , vulvar burning , vaginal itch , vulvar itch , leukorrhea . An analysis of the cytological tests performed in patients enrolled in the study highlighted a high prevalence of phlogistic type findings , often in association with varying degrees of atrophy in postmenopausal patients . Those patients suffering from chronic vaginitis undergoing balneotherapy showed a reduction in the prevalence of phlogistic findings after treatment . CONCLUSIONS Treatment with arsenical-ferruginose water led lo a marked reduction in the subjective symptoms reports by the study population ( particular evident in patients with chronic leukorrhea ) , as was confirmed by objective signs ( clinical , cytological and microbiological ) of phlogosis . This was accompanied by excellent tolerability . These results justify the use of balneotherapy , according to the classic techniques and methods , in chronic cervicovaginal phlogistic processes",
"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",
"Abstract . The effects of thermal water from Cserkeszölö in Hungary were appraised in a r and omised , double blind study conducted on 58 patients with osteoarthritis of the knee . Balneotherapy was delivered as a 15-day course of 30-min daily sessions performed with thermal water ( active treatment ) or tap water of similar colour and odour ( placebo treatment ) . The musculoskeletal status of participants was evaluated at baseline , at the end of the balneotherapy course , and 3 months later . Study endpoints ( initial pain , range of motion , tenderness on palpation , stair climbing , physicians ' opinion and subjective rating by patients , and ambulation ) were assessed using visual analogue scales and symptom scores . Both groups improved ; however , the magnitude of improvement was significantly greater in patients treated with thermal water from Cserkeszölö",
"The effect of spa therapy on chronic low back pain ( LBP ) was assessed in a r and omized trial comparing patients undergoing a 3-week therapy programme in a spa resort in France ( n = 50 ) with patients receiving ambulatory care ( n = 52 ) . After 3 weeks , patients in the spa group had significant improvement in their spine mobility and functional score ( Waddell index ) and a reduction in their daily duration of pain , pain intensity and drug consumption . The long-term effect was assessed after 9 months and showed continued reduction in pain and drug consumption , and improvement in spine mobility but no longer in functional score which returned to baseline level . It is concluded that spa therapy has a positive short-term and a moderate long-term effectiveness on chronic LBP",
"Forty-one patients with rheumatoid arthritis were treated for 2 weeks at a Tiberias spa hotel . R and omized into 2 groups , Group 1 received a combination of mineral baths and mud packs , and Group 2 had tap water baths only . Both groups had a significant but temporary improvement in Ritchie index . Group 1 showed a significant improvement in grip strength . No improvement was noticed in morning stiffness , 15 meter walk time and laboratory variables of disease activity in either group . Twelve patients with osteoarthritis ( OA ) received 2 weeks of treatment with mineral baths and mud packs . Statistically significant improvement for a period of 6 months was noticed in night pain , pain on passive motion , tenderness on palpation and in the index of severity of OA of the knee",
"OBJECTIVE To evaluate the cost effectiveness and cost utility of a 3-week course of combined spa therapy and exercise therapy in addition to st and ard treatment consisting of antiinflammatory drugs and weekly group physical therapy in ankylosing spondylitis ( AS ) patients . METHODS A total of 120 Dutch out patients with AS were r and omly allocated into 3 groups of 40 patients each . Group 1 was treated in a spa resort in Bad Hofgastein , Austria ; group 2 in a spa resort in Arcen , The Netherl and s. The control group stayed at home and continued their usual activities and st and ard treatment during the intervention weeks . After the intervention , all patients followed weekly group physical therapy . The total study period was 40 weeks . Effectiveness of the intervention was assessed by functional ability using the Bath Ankylosing Spondylitis Function Index ( BASFI ) . Utilities were measured with the EuroQoL ( EQ-5D(utility ) ) . A time-integrated summary score defined the clinical effects ( BASFI-area under the curve [ AUC ] ) and utilities ( EQ-5D(utility)-AUC ) over time . Both direct ( health care and non-health care ) and indirect costs were included . Re source utilization and absence from work were registered weekly by the patients in a diary . All costs were calculated from a societal perspective . RESULTS A total of 111 patients completed the diary . The between-group difference for the BASFI-AUC was 1.0 ( 95 % confidence interval [ 95 % CI ] 0.4 - 1.6 ; P = 0.001 ) for group 1 versus controls , and 0.6 ( 95 % CI 0.1 - 1.1 ; P = 0.020 ) for group 2 versus controls . The between-group difference for EQ-5D(utility)-AUC was 0.17 ( 95 % CI 0.09 - 0.25 ; P mean total costs per patient ( including costs for spa therapy ) in Euros ( euro ; ) during the study period were euro;3,023 for group 1 , euro;3,240 for group 2 , and euro;1,754 for the control group . The incremental cost-effectiveness ratio per unit effect gained in functional ability ( 0 - 10 scale ) was euro;1,269 ( 95 % CI 497 - 3,316 ) for group 1 , and euro;2,477 ( 95 % CI 601 - 12,098 ) for group 2 . The costs per quality -adjusted life year gained were euro;7,465 ( 95 % CI 3,294 - 14,686 ) for group 1 , and euro;18,575 ( 95 % CI 3,678 - 114,257 ) for group 2 . CONCLUSION Combined spa-exercise therapy besides st and ard treatment with drugs and weekly group physical therapy is more effective and shows favorable cost-effectiveness and cost-utility ratios compared with st and ard treatment alone in patients with AS",
"OBJECTIVE To study the effects of UV-B therapy and saline spa water given alone or in combination for the treatment of psoriasis . DESIGN R and omized , controlled , comparative study with blinded observers . SETTING Salies de Béarn , saline spa water center located in the southwest of France . PARTICIPANTS Seventy-one adult patients with psoriasis with a Psoriasis Area and Severity Index ( PASI ) score greater than 10 . INTERVENTION Patients were r and omly assigned to 1 of 3 treatments : spa water alone ( group A ) ; UV-B 311-nm phototherapy alone ( group B ) ; and a combination of the 2 therapies ( group C ) . The 3 groups were treated on a daily basis 5 days a week for a total of 21 days . MAIN OUTCOME MEASURES Change in PASI score from baseline as determined by an investigator blinded to r and omization ; variation in quality of life , adverse effects , and long-term effects ( 1 year after treatment ) . RESULTS Four patients dropped out because of secondary effects . Efficacy was similar in groups B and C , with changes in PASI of -64 % and -55 % , respectively at 3 weeks . For group A , change in PASI was -29 % , thus showing a minor therapeutic effect of saline spa water alone and poor efficacy compared with groups B and C ( P adverse effects were reported in groups A and C but did not reach significance . Combined saline spa water and UV-B therapy had no sparing effect on UV-B dosages . One year after treatment , no long-term benefit could be attributed specifically to a given regimen , but the patients had overall significantly better PASI scores than at baseline . CONCLUSIONS Saline spa water alone had a minor therapeutic effect in psoriasis , and the beneficial effect of bathing to enhance phototherapy was not demonstrated",
"The incidence of refractory atopic dermatitis has increased in teenagers and young adults . The purpose of this study was to control the skin symptoms of such patients in daily life . Seventy patients repeatedly took a 10-min 42 degrees C acidic hot-spring bath twice daily . The skin symptoms were improved in 76 % of cases . In 30 of 42 responders examined Staphylococcus aureus , detected on the skin surface , disappeared or decreased through balneotherapy . In contrast , S. aureus remained unchanged in 8 of 10 non-responders examined . Thus , the balneotherapy using acidic hot-spring water may be useful for controlling the skin symptoms of acute flares of refractory cases of atopic dermatitis",
"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"
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41173fa2-06ff-11f0-808a-c43d1ab1c353
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Green tea catechins ( GTCs ) are known to improve fat oxidation ( FOX ) during fasted , rested and exercise conditions wherein epigallocatechin-3-gallate ( EGCG ) is thought to be the most pharmacologically active and has been studied extensively . From the available data of r and omized controlled trials ( RCTs ) on EGCG , we carried out a systematic review and meta- analysis to eluci date whether EGCG consumption indeed increase energy expenditure ( EE ) and promote FOX . A systematic review of the literature was conducted using electronic data bases ( PubMed , Embase , Cochrane Library , CINAHL , JICST , JSTPLUS , and JMEDPLUS and others ) and eight RCTs were included . RCTs were review ed using Preferred Reporting Items for Systematic Review s and Meta-Analyses guidelines and method ological quality was assessed . After data extraction , results were aggregated using fixed- and r and om-effect approaches and expressed to quantify the relationship between the dose of EGCG for respiratory quotient ( RQ ) , EE and rate of FOX to compare the EGCG and placebo treatments . The meta- analysis results of verities of studies in terms of dose and length of duration revealed that EGCG supplementation provided significant mean difference ( MD ) when compared with placebo for RQ [ MD : -0.02 ; 95 % confidence intervals ( 95 % CI ) , -0.04 to 0.00 ; I2=67 % ; P=.01 ] and EE [ MD : 158.05 kJ/day ; 95 % CI , 4.72 to 311.38 ; I2=0 % ; P=.04 ] in fixed-effect approach . Changes in FOX did not reach the level of statistical significance . Meta-analyses of EGCG influence on the body mass index , waist circumference and total body fat mass ( TBFM ) were also examined and their impact on the promotion of FOX is reported . Effect of EGCG doses was also systematic ally review ed . Finding showed that EGCG intake moderately accelerates EE and reduces RQ . The analyses revealed that the EGCG result ed in difference in RQ and EE but the effect on the other measures of energy metabolism was relatively mild . Possibly , EGCG alone has the potential to increase metabolic rate at 300 mg dose . Collectively , the outcome supports the findings that EGCG has an effect on metabolic parameters . However , the large prospect i ve trials are needed to confirm the findings
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"Objectives : Drinking green tea is associated with many health benefits , including increased fat oxidation . We tested the hypothesis that epigallocatechin-3-gallate ( EGCG ) , the main green tea catechin , increases fat oxidation in obese men . Methods : Ten healthy overweight/obese males ( body mass index 31.3±0.8 kg/m2 ) were studied in a r and omized , placebo-controlled , double-blind crossover trial . Study supplements were low EGCG ( 300 mg ) , high EGCG ( 600 mg ) , caffeine ( 200 mg ) , EGCG/caffeine ( 300 mg/200 mg ) or placebo and were taken orally for 3 days . At the third day of supplementation , O2 consumption and CO2 production was measured by indirect calorimetry to assess energy expenditure and fat oxidation over 4 h each after overnight fasting and after a st and ardized test meal . Results : Energy expenditure was not affected by any supplementation , neither after overnight fasting nor after the test meal . During the first 2 h after overnight fasting , fat oxidation increased by 7.7 ( not significant , NS ) , 15.2 ( NS ) , 26.3 ( P , caffeine and EGCG/caffeine , respectively . During the first 2 h after the meal , the mean increase in fat oxidation was 33.3 ( P increases postpr and ial fat oxidation in obese men and this to the same extent as 200 mg caffeine , whereas high EGCG does not exert this effect . Fasting fat oxidation is increased only by caffeine ( with or without EGCG ) . There is no synergism of low EGCG and 200 mg caffeine . Energy expenditure is not affected by EGCG",
"It has been reported that green tea has a thermogenic effect , due to its caffeine content and probably also to the catechin , epigallocatechin-3-gallate ( EGCG ) . The main aim of the present study was to compare the effect of a mixture of green tea and Guarana extracts containing a fixed dose of caffeine and variable doses of EGCG on 24 h energy expenditure and fat oxidation . Fourteen subjects took part to this r and omized , placebo-controlled , double-blind , cross-over study . Each subject was tested five times in a metabolic chamber to measure 24 h energy expenditure , substrate oxidation and blood pressure . During each stay , the subjects ingested a capsule of placebo or capsules containing 200 mg caffeine and a variable dose of EGCG ( 90 , 200 , 300 or 400 mg ) three times daily , 30 min before st and ardized meals . Twenty-four hour energy expenditure increased significantly by about 750 kJ with all EGCG-caffeine mixtures compared with placebo . No effect of the EGCG-caffeine mixture was observed for lipid oxidation . Systolic and diastolic blood pressure increased by about 7 and 5 mmHg , respectively , with the EGCG-caffeine mixtures compared with placebo . This increase was significant only for 24 h diastolic blood pressure . The main finding of the study was the increase in 24 h energy expenditure with the EGCG-caffeine mixtures . However , this increase was similar with all doses of EGCG in the mixtures",
"Green tea ( GT ) consumption is known to be associated with enhanced cardiovascular and metabolic health . The purpose of this study is to examine the hypothesis that supplementation with GT alters insulin resistance and associated cardiovascular risk factors in obese , hypertensive patients . In a double-blind , placebo-controlled trial , 56 obese , hypertensive subjects were r and omized to receive a daily supplement of 1 capsule that contained either 379 mg of GT extract ( GTE ) or a matching placebo , for 3 months . At baseline and after 3 months of treatment , the anthropometric parameters , blood pressure , plasma lipid levels , glucose levels , creatinine levels , tumor necrosis factor α levels , C-reactive protein levels , total antioxidant status , and insulin levels were assessed . Insulin resistance was evaluated according to the homeostasis model assessment -insulin resistance protocol . After 3 months of supplementation , both systolic and diastolic blood pressures had significantly decreased in the GTE group as compared with the placebo group ( P in fasting serum glucose and insulin levels and insulin resistance were observed in the GTE group when compared with the placebo group . Serum tumor necrosis factor α and C-reactive protein were significantly lower , whereas total antioxidant status increased in the GTE group compared with the placebo ( P in the total and low-density lipoprotein cholesterol and triglycerides , but an increase in high-density lipoprotein cholesterol . In conclusion , daily supplementation with 379 mg of GTE favorably influences blood pressure , insulin resistance , inflammation and oxidative stress , and lipid profile in patients with obesity-related hypertension",
"Objectives : The development of obesity is characterized by an increase in adipose tissue mass and by concomitant and profound changes in almost all organ functions leading to diseases such as hypertension , diabetes mellitus and coronary heart disease . Recent data from human studies indicate that the consumption of green tea and green tea extracts may help reduce body weight , mainly body fat , by increasing postpr and ial thermogenesis and fat oxidation . However , human studies investigating the metabolic effects of the most predominant tea catechin , EGCG , alone are absent . Methods : In a r and omized double blind , placebo-controlled , cross-over pilot study , six overweight men were given 300 mg EGCG/d for 2d . Fasting and postpr and ial changes in energy expenditure ( EE ) and substrate oxidation were assessed . Results : Resting EE did not differ significantly between EGCG and placebo treatments , although during the first postpr and ial monitoring phase , respiratory quotient ( RQ ) values were significantly lower with EGCG compared to the placebo . Conclusions : These findings suggest that EGCG alone has the potential to increase fat oxidation in men and may thereby contribute to the anti-obesity effects of green tea . However , more studies with a greater sample size and a broader range of age and BMI are needed to define the optimum dose",
"BACKGROUND Current interest in the role of functional foods in weight control has focused on plant ingredients capable of interfering with the sympathoadrenal system . OBJECTIVE We investigated whether a green tea extract , by virtue of its high content of caffeine and catechin polyphenols , could increase 24-h energy expenditure ( EE ) and fat oxidation in humans . DESIGN Twenty-four-hour EE , the respiratory quotient ( RQ ) , and the urinary excretion of nitrogen and catecholamines were measured in a respiratory chamber in 10 healthy men . On 3 separate occasions , subjects were r and omly assigned among 3 treatments : green tea extract ( 50 mg caffeine and 90 mg epigallocatechin gallate ) , caffeine ( 50 mg ) , and placebo , which they ingested at breakfast , lunch , and dinner . RESULTS Relative to placebo , treatment with the green tea extract result ed in a significant increase in 24-h EE ( 4 % ; P decrease in 24-h RQ ( from 0.88 to 0.85 ; P . Twenty-four-hour urinary norepinephrine excretion was higher during treatment with the green tea extract than with the placebo ( 40 % , P EE and RQ nor on urinary nitrogen or catecholamines . CONCLUSIONS Green tea has thermogenic properties and promotes fat oxidation beyond that explained by its caffeine content per se . The green tea extract may play a role in the control of body composition via sympathetic activation of thermogenesis , fat oxidation , or both",
"This study evaluated the influence of a green tea catechin beverage on body composition and fat distribution in overweight and obese adults during exercise-induced weight loss . Participants ( n = 132 with 107 completers ) were r and omly assigned to receive a beverage containing approximately 625 mg of catechins with 39 mg caffeine or a control beverage ( 39 mg caffeine , no catechins ) for 12 wk . Participants were asked to maintain constant energy intake and engage in > or=180 min/wk moderate intensity exercise , including > or=3 supervised sessions per week . Body composition ( dual X-ray absorptiometry ) , abdominal fat areas ( computed tomography ) , and clinical laboratory tests were measured at baseline and wk 12 . There was a trend ( P = 0.079 ) toward greater loss of body weight in the catechin group compared with the control group ; least squares mean ( 95 % CI ) changes , adjusted for baseline value , age , and sex , were -2.2 ( -3.1 , -1.3 ) and -1.0 ( -1.9 , -0.1 ) kg , respectively . Percentage changes in fat mass did not differ between the catechin [ 5.2 ( -7.0 , -3.4 ) ] and control groups [ -3.5 ( -5.4 , 1.6 ) ] ( P = 0.208 ) . However , percentage changes in total abdominal fat area [ -7.7 ( -11.7 , -3.8 ) vs. -0.3 ( -4.4 , 3.9 ) ; P = 0.013 ] , subcutaneous abdominal fat area [ -6.2 ( -10.2 , -2.2 ) vs. 0.8 ( -3.3 , 4.9 ) ; P = 0.019 ] , and fasting serum triglycerides ( TG ) [ -11.2 ( -18.8 , -3.6 ) vs. 1.9 ( -5.9 , 9.7 ) ; P = 0.023 ] were greater in the catechin group . These findings suggest that green tea catechin consumption enhances exercise-induced changes in abdominal fat and serum TG",
"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",
"Objectives : To study the effects of green tea on body weight , and biochemical and hormonal profiles in obese Chinese women with polycystic ovary syndrome ( PCOS ) . Methods : Thirty-four obese Chinese women with PCOS were r and omized into either treatment with green tea capsules or placebo for 3 months . The anthropomentric measurements , and biochemical and hormonal profiles before and after treatment in each group were compared . Results : The body weight of the green tea group decreased by a nonsignificant 2.4 % after treatment ; whereas the body weight , body mass index ( BMI ) , and body fat content of the control group were significantly higher after 3 months . There were no differences in any of the hormone levels measured in either group . The biochemical profiles of the two groups were also similar except that there was a small but significant rise in the triglyceride level in the green tea group . Fewer patients in the green tea group remained amenorrhoeic , but this was not significantly different from the control group . Conclusions : Green tea supplementation did not significantly reduce body weight in obese women with PCOS , nor did it alter the glucose or lipid metabolism",
"OBJECTIVE this study examined the effects of a dentifrice containing green tea catechins on gingival oxidative stress and periodontal inflammation using a rat model . DESIGN twenty-four male Wister rats were r and omly divided into four groups . The first group ( Control group ) received no treatment for 8 weeks . Periodontal inflammation was induced in the second group for 8 weeks . Periodontal inflammation was induced in the last two groups for 8 weeks and dentifrices with or without green tea catechins were topically applied to the gingival sulcus daily for 4 weeks prior to the end of the experimental period . RESULTS rats that had experimental periodontal inflammation showed apical migration of the junctional epithelium , alveolar bone loss and inflammatory cell infiltration in the connective tissue subjacent to the junctional epithelium at 8 weeks , whilst the control group showed no pathologic changes . Topical application of a green tea catechin-containing dentifrice reduced inflammatory cell infiltration in the periodontal lesions to a greater degree than the control dentifrice at 8 weeks . The gingiva in which green tea catechin-containing dentifrice was applied also showed a lower level of expression of hexanoyl-lysine ( a marker of lipid peroxidation ) , nitrotyrosine ( a marker of oxidative protein damage ) , and tumour necrosis factor-α ( an indicator of pro-inflammatory cytokines ) at 8 weeks compared to gingiva in which the control dentifrice was applied . CONCLUSIONS adding green tea catechins to a dentifrice may contribute to prevention of periodontal inflammation by decreasing gingival oxidative stress and expression of pro-inflammatory cytokines",
"Regular consumption of green tea may be cardioprotective . In the present study we investigated the health effects of dietary supplementation with green tea catechins and the potential modifying effect of the catechol-O-methyltransferase ( COMT ) Val/Met genotype . Subjects ( sedentary males , aged 40 - 69 years , with BMI ≥ 28 and ≤ 38 kg/m(2 ) ) were r and omly assigned to consume decaffeinated green tea extract ( DGT ; 530 mg containing about 400 mg total catechins/capsule , twice daily ) and placebo in a complete cross-over design . Ambulatory blood pressure and biomarkers of metabolic function ( cholesterol , TAG , glucose and insulin ) were measured at weeks 0 and 6 . Although a marked increase in the concentration of plasma epigallocatechin gallate ( EGCG ) , urinary epigallocatechin ( EGC ) and urinary 4'-O-methyl EGC was found after DGT treatment , no effect on blood pressure or biomarkers of metabolic function was observed . However , a period × treatment interaction ( P for body-weight change . Despite a similar increase in estimated energy intake during intervention period 1 , body weight decreased by 0·64 ( sd 2·2 ) kg and increased by 0·53 ( sd 1·9 ) kg in the DGT and placebo groups , respectively ( P = 0·025 ) , suggesting a protective effect of green tea catechins on weight gain . Additionally , the COMT Val/Met genotype influenced urinary accumulation of EGC and 4'-O-methyl EGC ( P . Mean concentrations were lower in individuals homozygous for the high-activity G-allele , possibly reflecting increased metabolic flux and a more rapid conversion to downstream metabolic species , compared with individuals carrying at least one copy of the low-activity A-allele . Additional studies are needed to confirm these findings and further explore the modifying effect of genotype",
"AIMS To examine the effect of green tea extract ( GTE ) on obese women and to explore the relationship between GTE and obesity-related hormone peptides . METHODS A r and omized , double-blind , placebo-controlled clinical trial was conducted from July 2006 to June 2007 in Taipei Hospital , Taiwan . Seventy-eight of 100 obese women aged between 16 and 60 years with BMI > 27 kg/m(2 ) and who had not received any other weight control maneuvers within the last 3 months completed this study . The subjects were r and omly divided into Groups A and B. Group A ( n=41 ) received GTE while Group B ( n=37 ) took cellulose as a placebo , one capsule ( 400 mg ) three times each day for 12 weeks . The body weight ( BW ) , body mass index ( BMI ) and waist circumflex ( WC ) were measured at the beginning of the study and after 12 weeks of treatment with GTE . The data were compared and expressed as % reduction . RESULTS There was only a 0.3 % reduction in BW ( 0.15 kg ) after 12 weeks of treatment with GTE . There was no statistical difference in % reduction in BW , BMI and WC between the GTE and placebo groups . Within group comparison revealed that the GTE group had significant reduction in LDL-cholesterol and triglyceride , and marked increase in the level of HDL-cholesterol , adiponectin and ghrelin . On the other h and , the placebo group showed significant reduction in triglyceride only , and a marked increase in the level of ghrelin alone . CONCLUSIONS This study showed no statistical difference in % reduction in BW , BMI and WC between the GTE and placebo groups after 12 weeks of treatment . The intake of GTE ( 491 mg catechins containing 302 mg EGCG ) for 12 weeks is considered safe as shown by the results",
"UNLABELLED Epigallocatechin-3-gallate ( EGCG ) , a component of green tea , increases endurance performance in animals and promotes fat oxidation during cycle ergometer exercise in adult humans . PURPOSE We have investigated the hypothesis that short-term consumption of EGCG delays the onset of the ventilatory threshold ( VT ) and increases maximal oxygen uptake ( VO2max ) . METHODS In this r and omized , repeated- measures , double-blind study , 19 healthy adults ( 11 males and 8 females , age = 26 ± 2 yr ( mean ± SE ) ) received seven placebo or seven EGCG ( 135-mg ) pills . Forty-eight hours before data collection , participants began consuming three pills per day ; the last pill was taken 2 h before exercise testing . VT and VO2max were determined from breath-by-breath indirect calorimetry data collected during continuous incremental stationary cycle ergometer exercise ( 20 - 35 W·min(-1 ) ) , from rest until volitional fatigue . Each condition/exercise test was separated by a minimum of 14 d. RESULTS Compared with placebo , short-term EGCG consumption increased VO2max ( 3.123 ± 0.187 vs 3.259 ± 0.196 L·min(-1 ) , P = 0.04 ) . Maximal work rate ( 301 ± 15 vs 301 ± 16 W , P = 0.98 ) , maximal RER ( 1.21 ± 0.01 vs 1.22 ± 0.02 , P = 0.27 ) , and maximal HR were unaffected ( 180 ± 3 vs 180 ± 3 beats·min(-1 ) , P = 0.87 ) . In a subset of subjects ( n = 11 ) , maximal cardiac output ( determined via open-circuit acetylene breathing ) was also unaffected by EGCG ( 29.6 ± 2.2 vs 30.2 ± 1.4 L·min(-1 ) , P = 0.70 ) . Contrary to our hypothesis , EGCG decreased VO2 at VT ( 1.57 ± 0.11 vs 1.48 ± 0.10 L·min(-1 ) ) , but this change was not significant ( P = 0.06 ) . CONCLUSIONS Short-term consumption of EGCG increased VO2max without affecting maximal cardiac output , suggesting that EGCG may increase arterial-venous oxygen difference",
"BACKGROUND Tea consumption has been associated with decreased cardiovascular risk , but potential mechanisms of benefit are ill-defined . While epidemiologic studies suggest that drinking multiple cups of tea per day lowers low-density lipoprotein cholesterol ( LDL-C ) , previous trials of tea drinking and administration of green tea extract have failed to show any impact on lipids and lipoproteins in humans . Our objective was to study the impact of a theaflavin-enriched green tea extract on the lipids and lipoproteins of subjects with mild to moderate hypercholesterolemia . METHODS Double-blind , r and omized , placebo-controlled , parallel-group trial set in outpatient clinics in 6 urban hospitals in China . A total of 240 men and women 18 years or older on a low-fat diet with mild to moderate hypercholesterolemia were r and omly assigned to receive a daily capsule containing theaflavin-enriched green tea extract ( 375 mg ) or placebo for 12 weeks . Main outcome measures were mean percentage changes in total cholesterol , LDL-C , high-density lipoprotein cholesterol ( HDL-C ) , and triglyceride levels compared with baseline . RESULTS After 12 weeks , the mean + /- SEM changes from baseline in total cholesterol , LDL-C , HDL-C , and triglyceride levels were -11.3 % + /- 0.9 % ( P = .01 ) , -16.4 % + /- 1.1 % ( P = .01 ) , 2.3 % + /- 2.1 % ( P = .27 ) , and 2.6 % + /- 3.5 % ( P = .47 ) , respectively , in the tea extract group . The mean levels of total cholesterol , LDL-C , HDL-C , and triglycerides did not change significantly in the placebo group . No significant adverse events were observed . CONCLUSION The theaflavin-enriched green tea extract we studied is an effective adjunct to a low-saturated-fat diet to reduce LDL-C in hypercholesterolemic adults and is well tolerated",
"Research ers have long been investigating strategies that can increase athletes ' ability to oxidize fatty acids and spare carbohydrate , thus potentially improving endurance capacity . Green-tea extract ( epigallocatechin-3-gallate ; EGCG ) has been shown to improve endurance capacity in mice . If a green-tea extract can stimulate fat oxidation and as a result spare glycogen stores , then athletes may benefit through improved endurance performance . Eight male cyclists completed a study incorporating a 3-way crossover , r and omized , placebo-controlled , double-blinded , diet-controlled research design . All participants received 3 different treatments ( placebo 270 mg , EGCG 270 mg , and placebo 270 mg + caffeine 3 mg/kg ) over a 6-day period and 1 hr before exercise testing . Each participant completed 3 exercise trials consisting of 60 min of cycling at 60 % maximum oxygen uptake ( VO2(max ) ) immediately followed by a self-paced 40-km cycling time trial . The study found little benefit in consuming green-tea extract on fat oxidation or cycling performance , unlike caffeine , which did benefit cycling performance . The physiological responses observed during submaximal cycling after caffeine ingestion were similar to those reported previously , including an increase in heart rate ( EGCG 147 + /- 17 , caffeine 146 + /- 19 , and placebo 144 + /- 15 beats/min ) , glucose at the 40-min exercise time point ( placebo 5.0 + /- 0.8 , EGCG 5.4 + /- 1.0 , and caffeine 5.8 + /- 1.0 mmol/L ) , and resting plasma free fatty acids and no change in the amount of carbohydrate and fat being oxidized . Therefore , it was concluded that green-tea extract offers no additional benefit to cyclists over and above those achieved by using caffeine"
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Background Development of new peer or lay health-related lifestyle advisor ( HRLA ) roles is one response to the need to enhance public engagement in , and improve cost-effectiveness of , health improvement interventions . This article synthesis es evidence on the cost-effectiveness of HRLA interventions aim ed at adults in developed countries , derived from the first systematic review of the effectiveness , cost-effectiveness , equity and acceptability of different types of HRLA role . Methods The best available evidence on the cost-effectiveness of HRLA interventions was obtained using systematic search es of 20 electronic data bases and key journals , as well as search es of the grey literature and the internet . Interventions were classified according to the primary health behaviour targeted and intervention costs were estimated where necessary . Lifetime health gains were estimated ( in quality -adjusted life years , where possible ) , based on evidence of effectiveness of HRLAs in combination with published estimates of the lifetime health gains result ing from lifestyle changes , and assumptions over relapse . Incremental cost-effectiveness ratios are reported . Results Evidence of the cost-effectiveness of HRLAs was identified from 24 trials included in the systematic review . The interventions were grouped into eight areas . We found little evidence of effectiveness of HRLAs for promotion of exercise/improved diets . Where HRLAs were effective cost-effectiveness varied considerably : Incremental Cost effectiveness Ratios were estimated at £ 6,000 for smoking cessation ; £ 14,000 for a telephone based type 2 diabetes management ; and £ 250,000 or greater for promotion of mammography attendance and for HIV prevention amongst drug users . We lacked sufficient evidence to estimate ICERs for breastfeeding promotion and mental health promotion , or to assess the impact of HRLAs on health inequalities . Conclusions Overall , there is limited evidence suggesting that HRLAs are cost-effective in terms of changing health-related knowledge , behaviours or health outcomes . The evidence that does exist indicates that HRLAs are only cost-effective when they target behaviours likely to have a large impact on overall health-related quality of life . Further development of HRLA interventions needs to target specific population health needs where potential exists for significant improvement , and include rigorous evaluation to ensure that HRLAs provide sufficient value for money
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"BACKGROUND African Americans suffer disproportionately from diabetes complications , but little research has focused on how to improve diabetic control in this population . There are also few or no data on a combined primary care and community-based intervention approach . METHODS We r and omly assigned 186 urban African Americans with type 2 diabetes ( 76 % female , mean A SD age 59 A 9 years ) to 1 of 4 parallel arms : ( 1 ) usual care only ; ( 2 ) usual care + nurse case manager ( NCM ) ; ( 3 ) usual care + community health worker ( CHW ) ; ( 4 ) usual care + nurse case manager/community health worker team . Using the framework of the Precede-Proceed behavioral model , interventions included patient counseling regarding self-care practice s and physician reminders . RESULTS The 2-year follow-up visit was completed by 149 individuals ( 84 % ) . Compared to the Usual care group , the NCM group and the CHW group had modest declines in HbA(1c ) over 2 years ( 0.3 and 0.3 % , respectively ) , and the combined NCM/CHW group had a greater decline in HbA(1c ) ( 0.8 % . P = 0.137 ) . After adjustment for baseline differences and /or follow-up time , the combined NCM/CHW group showed improvements in triglycerides ( -35.5 mg/dl ; P = 0.041 ) and diastolic blood pressure , compared to the usual care group ( -5.6 mmHg ; P = 0.042 ) . CONCLUSIONS Combined NCM/CHW interventions may improve diabetic control in urban African Americans with type 2 diabetes . Although results were clinical ly important , they did not reach statistical significance . This approach deserves further attention as a means to reduce the excess risk of diabetic complications in African Americans",
"Abstract . Aims /hypothesis : To develop a long-term economic model of health care for Type II diabetes initially for the United Kingdom ; characterize experiences of diabetes-related morbidities and the use of health care re sources among a typical Type II diabetes cohort ; to estimate lifetime differences in expected health outcomes and costs attributable to Type II diabetes ; and to facilitate evaluation of policies or interventions in treating Type II diabetes from the funder 's perspective . Methods : A compact spreadsheet structure of interconnected Markov chain modules was developed to facilitate rapid estimation of costs and outcomes for whole population s. Recent clinical findings from the United Kingdom Prospect i ve Diabetes Study and other sources were incorporated and a detailed costing module developed from United Kingdom observational data . Results : The model allows the assessment of costs and long-term complications experienced by people suffering from Type II diabetes , including direct health care costs associated with the main diabetic complications and second-order effects on other health services required by such patients . Initial results suggest that the lifetime cost of health care for patients from the diagnosis of diabetes is more than double that for an equivalent non-diabetic population . Conclusion /interpretation : The model is intended for use by health care policy makers and payers to assess the long-term budgetary impact of trends in a variety of demographic and epidemiological factors on future services , and is also useful to physicians when considering the impact of new treatment strategies or programmes to modify risk factors for diabetic complications . [ Diabetologia ( 2001 ) 44 : 2140–2155",
"Abstract Objective To compare the hazards of cigarette smoking in men who formed their habits at different periods , and the extent of the reduction in risk when cigarette smoking is stopped at different ages . Design Prospect i ve study that has continued from 1951 to 2001 . Setting United Kingdom . Participants 34 439 male British doctors . Information about their smoking habits was obtained in 1951 , and periodically thereafter ; cause specific mortality was monitored for 50 years . Main outcome measures Overall mortality by smoking habit , considering separately men born in different periods . Results The excess mortality associated with smoking chiefly involved vascular , neoplastic , and respiratory diseases that can be caused by smoking . Men born in 1900 - 1930 who smoked only cigarettes and continued smoking died on average about 10 years younger than lifelong non-smokers . Cessation at age 60 , 50 , 40 , or 30 years gained , respectively , about 3 , 6 , 9 , or 10 years of life expectancy . The excess mortality associated with cigarette smoking was less for men born in the 19th century and was greatest for men born in the 1920s . The cigarette smoker versus non-smoker probabilities of dying in middle age ( 35 - 69 ) were 42 % ν24 % ( a twofold death rate ratio ) for those born in 1900 - 1909 , but were 43 % ν 15 % ( a threefold death rate ratio ) for those born in the 1920s . At older ages , the cigarette smoker versus non-smoker probabilities of surviving from age 70 to 90 were 10 % ν 12 % at the death rates of the 1950s ( that is , among men born around the 1870s ) but were 7 % ν 33 % ( again a threefold death rate ratio ) at the death rates of the 1990s ( that is , among men born around the 1910s ) . Conclusion A substantial progressive decrease in the mortality rates among non-smokers over the past half century ( due to prevention and improved treatment of disease ) has been wholly outweighed , among cigarette smokers , by a progressive increase in the smoker ν non-smoker death rate ratio due to earlier and more intensive use of cigarettes . Among the men born around 1920 , prolonged cigarette smoking from early adult life tripled age specific mortality rates , but cessation at age 50 halved the hazard , and cessation at age 30 avoided almost all of it",
"PURPOSE The purpose of this r and omized controlled trial is to determine the effectiveness of an intervention led by promotoras ( community lay workers ) on the glycemic control , diabetes knowledge , and diabetes health beliefs of Mexican Americans with type 2 diabetes living in a major city on the Texas-Mexico border . METHODS One hundred fifty Mexican American participants were recruited at a Catholic faith-based clinic and r and omized into 2 groups . Personal characteristics , acculturation , baseline A1C level , diabetes knowledge , and diabetes health beliefs were measured . The intervention was culturally specific and consisted of participative group education , telephone contact , and follow-up using inspirational faith-based health behavior change postcards . The A1C levels , diabetes knowledge , and diabetes health beliefs were measured 3 and 6 months postbaseline , and the mean change between the groups was analyzed . RESULTS The 80 % female sample , with a mean age of 58 years , demonstrated low acculturation , income , education , health insurance coverage , and strong Catholicism . No significant changes were noted at the 3-month assessment , but the mean change of the A1C levels , F(1 , 148 ) = 10.28 , P diabetes knowledge scores , F(1 , 148 ) = 9.0 , P health belief scores decreased in both groups . CONCLUSIONS The intervention result ed in decreased A1C levels and increased diabetes knowledge , suggesting that using promotoras as part of an interdisciplinary team can result in positive outcomes for Mexican Americans who have type 2 diabetes . Clinical implication s and recommendations for future research are suggested",
"OBJECTIVES A community trial was undertaken to evaluate the effectiveness of the North Carolina Breast Cancer Screening Program , a lay health advisor network intervention intended to increase screening among rural African American women 50 years and older . METHODS A stratified r and om sample of 801 African American women completed baseline ( 1993 - 1994 ) and follow-up ( 1996 - 1997 ) surveys . The primary outcome was self-reported mammography use in the previous 2 years . RESULTS The intervention was associated with an overall 6 percentage point increase ( 95 % confidence interval [ CI ] = -1 , 14 ) in community-wide mammography use . Low-income women in intervention counties showed an 11 percentage point increase ( 95 % CI = 2 , 21 ) in use above that exhibited by low-income women in comparison counties . Adjustment for potentially confounding characteristics did not change the results . CONCLUSIONS A lay health advisor intervention appears to be an effective public health approach to increasing use of screening mammography among low-income , rural population",
"OBJECTIVES This study evaluated the effectiveness ( changes in health behaviors , health status , and health service utilization ) of a self-management program for chronic disease design ed for use with a heterogeneous group of chronic disease patients . It also explored the differential effectiveness of the intervention for subjects with specific diseases and comorbidities . METHODS The study was a six-month r and omized , controlled trial at community-based sites comparing treatment subjects with wait-list control subjects . Participants were 952 patients 40 years of age or older with a physician-confirmed diagnosis of heart disease , lung disease , stroke , or arthritis . Health behaviors , health status , and health service utilization , as determined by mailed , self-administered question naires , were measured . RESULTS Treatment subjects , when compared with control subjects , demonstrated improvements at 6 months in weekly minutes of exercise , frequency of cognitive symptom management , communication with physicians , self-reported health , health distress , fatigue , disability , and social/role activities limitations . They also had fewer hospitalizations and days in the hospital . No differences were found in pain/physical discomfort , shortness of breath , or psychological well-being . CONCLUSIONS An intervention design ed specifically to meet the needs of a heterogeneous group of chronic disease patients , including those with comorbid conditions , was feasible and beneficial beyond usual care in terms of improved health behaviors and health status . It also result ed in fewer hospitalizations and days of hospitalization",
"Aims /hypothesisThe aim of this study was to develop a simulation model for Type 2 diabetes that can be used to estimate the likely occurrence of major diabetes-related complications over a lifetime , in order to calculate health economic outcomes such as quality -adjusted life expectancy . Methods Equations for forecasting the occurrence of seven diabetes-related complications and death were estimated using data on 3642 patients from the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) . After examining the internal validity , the UKPDS Outcomes Model was used to simulate the mean difference in expected quality -adjusted life years between the UKPDS regimens of intensive and conventional blood glucose control . Results The model ’s forecasts fell within the 95 % confidence interval for the occurrence of observed events during the UKPDS follow-up period . When the model was used to simulate event history over patients ’ lifetimes , those treated with a regimen of conventional glucose control could expect 16.35 undiscounted quality -adjusted life years , and those receiving treatment with intensive glucose control could expect 16.62 quality -adjusted life years , a difference of 0.27 ( 95 % CI : −0.48 to 1.03 ) . Conclusions /interpretationsThe UKPDS Outcomes Model is able to simulate event histories that closely match observed outcomes in the UKPDS and that can be extrapolated over patients ’ lifetimes . Its validity in estimating outcomes in other groups of patients , however , remains to be evaluated . The model allows simulation of a range of long-term outcomes , which should assist in informing future economic evaluations of interventions in Type 2 diabetes",
"OBJECTIVE To determine whether a culturally appropriate clinic- and community-based intervention for African-American women with type 2 diabetes will increase moderate-intensity physical activity ( PA ) . RESEARCH DESIGN AND METHODS In this r and omized controlled trial conducted at seven practice s in central North Carolina , 200 African-American women , > or = 40 years of age with type 2 diabetes , were r and omized to one of three treatment conditions : clinic and community ( group A ) , clinic only ( group B ) , or minimal intervention ( group C ) . The clinic-based intervention ( groups A and B ) consisted of four monthly visits with a nutritionist who provided counseling to enhance PA and dietary intake that was tailored to baseline practice s and attitudes ; the community-based intervention ( group A ) consisted of three group sessions and 12 monthly phone calls from a peer counselor and was design ed to provide social support and reinforce behavior change goals ; and the minimal intervention ( group C ) consisted of educational pamphlets mailed to participants . The primary study outcome was the comparison of PA levels between groups assessed at 6 and 12 months by accelerometer , which was worn while awake for 7 days . RESULTS Totals of 175 ( 88 % ) and 167 ( 84 % ) participants completed PA assessment at 6 and 12 months , respectively . For comparison of PA , the P value for overall group effect was 0.014 . Comparing group A with C , the difference in the average adjusted mean for PA was 44.1 kcal/day ( 95 % CI 13.1 - 75.1 , P = 0.0055 ) . Comparing group B with C , the difference in the average adjusted mean was 33.1 kcal/day ( 95 % CI 3.3 - 62.8 , P = 0.029 ) . The intervention was acceptable to participants : 88 % were very satisfied with clinic-based counseling to enhance PA , and 86 % indicated that the peer counselor 's role in the program was important . CONCLUSIONS The intervention was associated with a modest enhancement of PA and was acceptable to participants",
"OBJECTIVES Body and Soul was a collaborative effort among two research universities , a national voluntary agency ( American Cancer Society ) , and the National Institutes of Health to disseminate and evaluate under real-world conditions the impact of previously developed dietary interventions for African Americans . METHODS Body and Soul was constructed from two successful research -based interventions conducted in African-American churches . Components deemed essential from the prior interventions were combined , and then tested in a cluster r and omized-effectiveness trial . The primary outcome was fruit and vegetable intake measured with two types of food frequency question naires at baseline and 6-month follow-up . RESULTS At the 6-month follow-up , intervention participants showed significantly greater fruit and vegetable ( F&V ) intake relative to controls . Post-test differences were 0.7 and 1.4 servings for the 2-item and 17-item F&V frequency measures , respectively . Statistically significant positive changes in fat intake , motivation to eat F&V , social support , and efficacy to eat F&V were also observed . CONCLUSIONS The results suggest that research -based interventions , delivered collaboratively by community volunteers and a health-related voluntary agency , can be effectively implemented under real-world conditions",
"There is universal agreement [ 1 - 4 ] that women 50 to 69 years of age should undergo screening mammography because r and omized , controlled trials have shown that such screening reduces breast cancer mortality in this age group [ 5 , 6 ] . This consensus is bolstered by the results of cost-effectiveness analyses that consistently show that this benefit can be achieved at a reasonable cost [ 7 - 9 ] . In contrast , whether women 40 to 49 years of age should undergo screening mammography is controversial [ 10 - 15 ] . Pooled results of large r and omized , controlled trials have shown no mortality reduction in 40- to 49-year-old women after 7 to 9 years of screening [ 5 , 16 - 18 ] . However , a statistically significant reduction in breast cancer mortality becomes apparent 10 to 14 years after the initiation of screening [ 19 ] . Some authors have argued that this delayed benefit should not be ignored [ 11 ] . However , the reality of constrained health care re sources requires that any benefit from preventive services be achieved at a reasonable cost . Two recently published analyses [ 20 , 21 ] suggest that mammographic screening in younger women may be as cost-effective as screening in older women . The first analysis [ 20 ] calculated average cost-effectiveness by comparing a strategy of screening 40- to 69-year-old women with no screening . Most of the benefit achieved by using this strategy occurs when women are 50 to 69 years of age . Therefore , this analysis did not address whether it is cost-effective to screen women from 40 to 49 years of age in addition to screening them from 50 to 69 years of age . To determine whether the additional benefit obtained by extending screening mammography to women 40 to 49 years of age comes at a reasonable cost would require an incremental cost-effectiveness analysis [ 22 - 26 ] . The second analysis [ 21 ] used a simplified life-expectancy accounting method , did not discount costs or benefits , and associated screening mammography with unsubstantiated mortality reductions ( 30 % for the base case ) . Neither analysis [ 20 , 21 ] included an important aspect of the results of screening mammography trials in 40- to 49-year-old women : that is , no benefit occurs until 10 years after the initiation of screening . An earlier analysis [ 10 ] found screening mammography to be more expensive in women 40 to 49 years of age than in women 50 years of age and older . This previous analysis calculated incremental cost-effectiveness , discounted costs and benefits , and included an estimated delay between the onset of screening and the onset of a mortality benefit . Our analysis extends this work by including up date d pooled results of the r and omized , controlled trials [ 19 ] ; actual delay times before the onset of benefits ; and up date d costs of mammography and treatment of breast cancer . Methods Model We developed a Markov model [ 27 , 28 ] that compared the life expectancy of women undergoing different breast cancer screening strategies . Except for women in whom breast cancer was diagnosed at the initiation of screening , women were healthy at entry into the model . At the end of each 1-year cycle , women were in one of four health states : They remained healthy , developed breast cancer and remained alive , died of breast cancer , or died of another cause . The transition probabilities [ that is , the probabilities of developing breast cancer , dying of breast cancer , and dying of another cause ] were both age- and strategy -dependent . The base-case analysis compared three strategies : 1 ) no screening ; 2 ) screening biennially from 50 to 69 years of age ; and 3 ) screening every 18 months from 40 to 49 years of age , followed by screening biennially from 50 to 69 years of age . The rationale for these screening intervals is discussed below . We calculated the cost-effectiveness of screening in women 50 years of age and older by comparing the first strategy with the second strategy . To determine the incremental cost-effectiveness of screening in 40- to 49-year-old women , we compared the second and third strategies . Costs and benefits were discounted at a rate of 3 % per year for the base-case analysis [ 23 ] . Benefits Trials of screening mammography have shown no reduction in breast cancer mortality among screened women until several years after the initiation of screening [ 5 , 18 , 29 , 30 ] . Meta-analyses and one pooled analysis have shown that among 40- to 49-year-old women , the summary relative risk reduction in breast cancer mortality 7 to 9 years after the initiation of screening is about 1 , indicating no reduction in mortality [ 5 , 16 - 18 ] . Ten to 12 years after the initiation of screening , a nonsignificant trend toward reduced mortality is evident in the screened group ( Figure 1 , left ) [ 5 , 18 , 29 , 30 ] . Recently up date d results show a statistically significant 16 % reduction that occurs 10 to 14 years after the initiation of screening [ 19 ] . For women 50 to 69 years of age , there is an initial period of about 5 years that shows no benefit from screening ( Figure 1 , right ) [ 18 , 29 , 30 ] . Figure 1 . Cumulative breast cancer mortality in screened ( black circles ) compared with nonscreened ( white circles ) women . Left . Right . In our model , for women who start screening at 50 years of age , a 27 % reduction in breast cancer mortality ( Table 1 ) [ 5 ] begins 5 years after the initiation of screening and continues until age 74 years . Although screening ends at 69 years of age , we assumed that women would continue to benefit for another 5 years because of early detection of breast cancer in the last years of screening . For women who begin screening at 40 years of age , a 16 % reduction in breast cancer mortality starts at age 50 years ; this reduction increases to 27 % at age 55 years . Table 1 . Information Used To Calculate Life Expectancy Screening Interval The screening interval in r and omized , controlled trials of screening mammography has varied from 12 to 33 months for women 50 years of age and older . Pooled results of the efficacy of mammography stratified by length of screening interval do not differ for women in this age group [ 5 ] . From published results [ 5 ] , we determined a 28 % ( 95 % CI , 15 % to 31 % ) reduction in breast cancer mortality in women 50 years of age and older who were screened every 18 to 33 months and a 25 % ( CI , 1 % to 43 % ) reduction in those screened every 12 months . For the base-case analysis , we therefore chose to perform biennial screening in women 50 years of age and older because screening more often only increases cost without increasing the benefits of screening . For the base-case analysis , we used the pooled reduction in breast cancer mortality ( 27 % ) [ 5 ] from all r and omized , controlled trials to determine the cost-effectiveness of biennial screening in 50- to 69-year-old women ; in a sensitivity analysis , we determined the cost-effectiveness of annual screening . The screening interval in r and omized , controlled trials has varied from 12 to 24 months for women 40 to 49 years of age . Pooled results of the efficacy of screening mammography stratified by length of screening interval did not show a statistically significant reduction in breast cancer mortality for 12-month or 18- to 24-month screening intervals [ 5 ] . As noted above , recently reported pooled results of all r and omized , controlled trials , which on average used a screening interval of 18 months , showed a statistically significant 16 % reduction in breast cancer mortality 10 to 14 years after the initiation of screening [ 19 ] . We therefore assumed that a 16 % reduction in breast cancer mortality would be achieved with screening done every 18 months . This screening interval is consistent with the guidelines of organizations [ 2 , 3 ] that recommend screening every 1 to 2 years for 40- to 49-year-old women . In sensitivity analyses , we calculated the cost-effectiveness of annual and biennial screening , assuming the same 16 % reduction in breast cancer mortality among screened women . Utilities Because there are few data on the utility that women place on life after treatment of breast cancer or the utility placed on living with metastatic breast cancer , we did not include utilities in the base-case analysis . Data from a small Australian study [ 33 ] ( which observed a utility of about 0.8 for life after treatment of breast cancer and a utility of about 0.3 for life with metastatic cancer ) are included in a sensitivity analysis to determine the extent to which cost per year of life saved might differ from cost per quality -adjusted life-year saved . Costs We included three costs : the cost of screening mammographic examinations , the cost of evaluating abnormal mammograms , and the cost of treating breast cancer ( Table 2 ) . Additional details on derivations of costs are given in the Appendix . The cost of screening mammography was based on the average cost ( $ 91 ) reported by the National Cancer Institute 's National Survey of Mammography Facilities [ 34 ] . This cost was inflated to 1995 dollars ( $ 106 ) by using the consumer price index for medical services . We assumed that women in whom breast cancer was diagnosed continued to undergo screening mammography of the opposite breast , at the same cost , after the initial diagnosis of breast cancer . Table 2 . Information Used to Calculate Costs The cost of evaluating abnormal mammographic results was calculated as a weighted average of procedures that may follow abnormal mammograms . This cost was also inflated to 1995 dollars . The distribution and types of follow-up procedures were based on those reported by the National Cancer Institute 's National Survey of Mammography Facilities [ 35 ] . A range of costs for each procedure was based on data from Medicare , Pennsylvania Blue Cross , Group Health Cooperative , and Kaiser Permanente ( Brown M. Personal communication ) . The percentage of abnormal mammograms was based on the percentage seen with high- quality modern screening mammography ( Table 2 ) [ 36 ] . Population -based data on the cancer stage at diagnosis in screened compared with nonscreened women are sparse .",
"PURPOSE Cancer survivors smoke at rates that are only slightly lower than the general population . This article reports on the final outcomes of Partnership for Health , a smoking cessation intervention for smokers in the Childhood Cancer Survivors Study ( CCSS ) . METHODS This study is a r and omized control trial with follow-up at 8 and 12 months that involved smokers ( n = 796 ) enrolled onto the CCSS cohort . Participants were r and omly assigned to either a self-help or a peer-counseling program that included up to six telephone calls from a trained childhood cancer survivor , tailored and targeted material s , and free nicotine replacement therapy . The intervention was delivered by telephone and postal service mail . RESULTS The quit rate was significantly higher in the counseling group compared with the self-help group at both the 8-month ( 16.8 % v 8.5 % ; P baseline self-efficacy and readiness to change , the intervention group was twice as likely to quit smoking , compared with the self-help group . Smoking cessation rate increased with an increase in the number of counseling calls . The cost of delivering the intervention was approximately 300 dollars per participant . The incremental cost-effectiveness of the intervention compared with controls was 5,371 dollars per additional quit . CONCLUSION Interventions to prevent future illnesses are of critical importance to childhood cancer survivors . The Partnership for Health intervention result ed in a doubling of smoking cessation quit rates . Because of the seriousness of smoking among childhood cancer survivors , this intervention model may be appropriate as a multicomponent treatment program for survivors who smoke",
"INTRODUCTION Mammography is underused by certain groups of women , in particular poor and minority women . We developed a lay health advisor ( LHA ) intervention based on behavioral theories and tested whether it improved mammography attendance in Robeson County , NC , a rural , low-income , triracial ( white , Native American , African American ) population . METHODS A total of 851 women who had not had a mammogram within the past year were r and omly assigned to the LHA intervention ( n = 433 ) or to a comparison arm ( n = 418 ) during 1998 - 2002 . Rates of mammography use after 12 - 14 months ( as verified by medical record review ) were compared using a chi-square test . Baseline and follow-up ( at 12 - 14 months ) surveys were used to obtain information on demographics , risk factors , and barriers , beliefs , and knowledge about mammography . Linear regression , Mantel-Haenszel statistics , and logistic regression were used to compare barriers , beliefs , and knowledge from baseline to follow-up and to identify baseline factors associated with mammography . RESULTS At follow-up , 42.5 % of the women in the LHA group and 27.3 % of those in the comparison group had had a mammogram in the previous 12 months ( relative risk = 1.56 , 95 % confidence interval [ CI ] = 1.29 to 1.87 ) . Compared with those in the comparison group , women in the LHA group displayed statistically significantly better belief scores ( difference = 0.46 points on a 0 - 10 scale , 95 % CI = 0.15 to 0.77 ) and reduced barriers at follow-up ( difference = -0.77 points , 95 % CI = -1.02 to -0.53 ) , after adjusting for baseline scores . CONCLUSIONS LHA interventions can improve mammography utilization . Future studies are needed to assess strategies to disseminate effective LHA interventions to underserved population",
"The objective of this study was to determine whether the Arthritis Self-Management Programme ( ASMP ) improves perceptions of control , health behaviours and health status , and changes use of health care re sources . The design was a pragmatic r and omized controlled study ; participants were allocated to ASMP ( Intervention Group ) or a 4-month waiting-list Control Group . The Intervention Group completed a 12-month follow-up . In total , 544 people with arthritis were recruited from the community--311 in the Intervention Group and 233 in the Control Group . Main outcome measures included : arthritis self-efficacy , health behaviours ( exercise , cognitive symptom management , diet and relaxation ) and health status ( pain , fatigue , anxiety , depression and positive affect ) . At 4 months follow-up , the ASMP had a significant effect on arthritis self-efficacy for other symptoms and pain subscales . Performance of a range of health behaviours ( cognitive symptom management , communication with physicians , dietary habit , exercise and relaxation ) was significantly greater among the Intervention Group . The Intervention Group were significantly less depressed and had greater positive mood . In addition , trends towards decreases on fatigue and anxiety were noted . Physical functioning , pain and GP visits remained stable at 4 months . A similar pattern of findings was found at 12 months follow-up for the Intervention Group . Furthermore , a significant improvement was found on pain and visits to GPs had decreased . Apart from a small improvement on physical functioning among the Intervention Group participants with osteoarthritis 12 months , all effects were independent of the type of arthritis . The findings suggest that the ASMP is effective in promoting improvements in perception of control , health behaviours and health status , when delivered in UK setting ",
"OBJECTIVE To assess the effectiveness of including a social support intervention ( ' buddy system ' ) in a group treatment programme to aid smoking cessation . METHODS Five hundred and sixty-three smokers attended groups at a smokers ' clinic . These groups were r and omized either to be ( a ) groups in which smokers were paired with another person to provide mutual support ( buddy condition : n=237 in 14 groups ) or ( b ) to receive the same treatment without the buddy component ( control : n=326 in 20 groups ) . Participants were seen weekly for the first 4 weeks after stopping then followed up again after 26 weeks . RESULTS Smokers in the buddy condition were no more likely than smokers in the control condition to stay abstinent at 1 , 4 or 26 weeks . The effect was in the right direction at week one post-quit but after controlling for potential confounders the difference was not significant ( odds ratio=1.45 ( 95 % CI ; 0.92 - 2.29 ) , p=0.06 ) . CONCLUSIONS We were unable to show that a buddy system improved abstinence rates of group treatment programmes . This might be due to the high level of social support already achieved through the groups . PRACTICE IMPLICATION S The buddy system is a simple and very low cost addition to a group treatment programme ; but the results from this study suggest that the kind of buddy system tested may not add substantially to the success rates . However there may be merits in a more intensive or protracted form of buddying",
"Objective : Supporting patients ’ self care could have a major effect on the management of long-term conditions , which has led to worldwide interest in effective self care interventions . In Engl and , self care support is being developed through the “ Expert Patients Programme ” , which provides lay-led generic courses to improve patients ’ self care skills . However , the clinical and cost effectiveness of such courses remains unclear . Methods : Two-arm pragmatic r and omised controlled trial design with waiting list control in community setting s in Engl and . 629 patients with a wide range of self-defined long-term conditions were studied . The lay-led self care support group involved 6-weekly sessions to teach self care skills . Primary outcomes were self-efficacy , reported energy and routine health services utilisation at 6 months . A cost-effectiveness analysis was also conducted . Results : Patients receiving immediate course access reported considerably greater self-efficacy and energy at 6-month follow-up , but reported no statistically significant reductions in routine health services utilisation over the same time period . The cost-effectiveness analysis showed that patients receiving immediate course access reported considerably greater health related quality of life , and a small reduction in costs . If a quality adjusted life year was valued at £ 20 000 ( $ 39 191 ; € 30 282 ) , there was a 70 % probability that the intervention was cost effective . Conclusions : Lay-led self care support groups are effective in improving self-efficacy and energy levels among patients with long-term conditions , and are likely to be cost effective over 6 months at conventional values of a decision-maker ’s willingness to pay . They may be a useful addition to current services in the management of long-term conditions",
"AIMS To assess the effect on abstinence rates of pairing up smokers attending a general practice smokers , clinic to provide mutual support between clinic sessions . DESIGN R and omized controlled trial comparing a \" buddy \" condition with a \" solo condition \" in which smokers received the e same treatment but were not paired up . SETTING A general practice smokers ' clinic in London . PARTICIPANTS One hundred and seventy-two smokers recruited by mailshot . INTERVENTION . Smokers attended a nurse-led smokers clinic 1 week prior to their quit date , on the quite date , 1 week later and 3 weeks after that . Smokers in the buddy condition were paired with another smoker trying to give up at the same time to provide mutual support between clinic sessions . MEASUREMENT The main outcome measure was the percentage of smokers still abstinent from cigarettes at end of treatment ( weeks from quite date ) , verified by expired air carbon monoxide concentration . FINDINGS The percentage of smokers still abstinent at the end of treatment was significantly higher in the buddy condition than the solo condition ( 27 % vs. 12 % ) . CONCLUSIONS A buddy system can provide an effective element of a smoking cessation intervention at minimal cost . Further research is needed to establish the long-term efficacy of this approach and examine the effectiveness of incorporating social support into other types of smoking cessation programmes",
"BACKGROUND Few studies compare the influence of different types of dietary interventions on the dietary practice s of Latinas in the short and long term . The present study examined the 1-year impact of two innovative behavior-change approaches to reduce dietary fat and increase fiber . DESIGN Three-group r and omized controlled trial : ( 1 ) personalized dietary counseling via lay heath advisors ( promotoras ) plus tailored print material s delivered via the mail , ( 2 ) tailored mailed print material s only , and ( 3 ) targeted mailed \" off-the-shelf \" material s. SETTING / PARTICIPANTS A total of 357 Latinas were r and omly assigned to the three aforementioned conditions . INTERVENTION Promotora and tailored print material s. MAIN OUTCOME MEASURES Fat intake ( total grams of fat and percent calories from dietary fat ) and number of grams of dietary fiber . RESULTS Earlier work reported that at immediate post-intervention the promotora group achieved significantly lower levels of total fat grams , and lower levels of energy intake , total saturated fat , total carbohydrates , glucose , and fructose than the targeted group . However , the present longitudinal analyses suggest that the effects achieved by the promotoras dissipated over the 12-month follow-up period while the effects of the tailored group concurrently improved . CONCLUSIONS The high interactivity ( i.e. , calls , visits ) of the promotora condition may have been the most salient reinforcer and may have led to further tailoring , making this type of intervention more effective than the comparison groups in the short term . Further research should explore whether booster sessions involving promotoras help to maintain the impact over time",
"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 Exclusive breastfeeding is recommended worldwide but not commonly practised . We undertook a r and omised controlled study of the efficacy of home-based peer counselling to increase the proportion of exclusive breastfeeding among mothers and infants residing in periurban Mexico City . METHODS Two intervention groups with different counselling frequencies , six visits ( 44 ) and three visits ( 52 ) , were compared with a control group ( 34 ) that had no intervention . From March , 1995 , to September , 1996 , 170 pregnant women were identified by census and invited to participate in the study . Home visits were made during pregnancy and early post partum by peer counsellors recruited from the same community and trained by La Leche League . Data were collected by independent interview . Exclusive breastfeeding was defined by WHO criteria . FINDINGS 130 women participated in the study . Only 12 women refused participation . Study groups did not differ in baseline factors . At 3 months post partum , exclusive breastfeeding was practised by 67 % of six-visit , 50 % of three-visit , and 12 % of control mothers ( intervention groups vs controls , p Duration of breastfeeding was significantly ( p=0.02 ) longer in intervention groups than in controls , and fewer intervention than control infants had an episode of diarrhoea ( 12 % vs 26 % , p=0.03 ) . INTERPRETATION This is the first reported community-based r and omised trial of breastfeeding promotion . Early and repeated contact with peer counsellors was associated with a significant increase in breastfeeding exclusivity and duration . The two-fold decrease in diarrhoea demonstrates the importance of breastfeeding promotion to infant health",
"BACKGROUND Most mothers stop breast-feeding before the recommended 6 months post partum . A systematic review showed that breast-feeding support programs by health care professionals did not substantially improve breast-feeding outcomes beyond 2 months post partum . We conducted a r and omized controlled trial to evaluate the effect of peer ( mother-to-mother ) support on breast-feeding duration among first-time breast-feeding mothers . METHODS We recruited 256 breast-feeding mothers from 2 semi-urban community hospitals near Toronto and r and omly assigned them to a control group ( conventional care ) or a peer support group ( conventional care plus telephone-based support , initiated within 48 hours after hospital discharge , from a woman experienced with breast-feeding who attended a 2.5-hour orientation session ) . Follow-up of breast-feeding duration , maternal satisfaction with infant feeding method and perceptions of peer support received was conducted at 4 , 8 and 12 weeks post partum . RESULTS Significantly more mothers in the peer support group than in the control group continued to breast-feed at 3 months post partum ( 81.1 % v. 66.9 % , p = 0.01 ) and did so exclusively ( 56.8 % v. 40.3 % , p = 0.01 ) . Breast-feeding rates at 4 , 8 and 12 weeks post partum were 92.4 % , 84.8 % and 81.1 % respectively among the mothers in the peer support group , as compared with 83.9 % , 75.0 % and 66.9 % among those in the control group ( p corresponding relative risks were 1.10 ( 95 % confidence interval [ CI ] 1.01 - 2.72 ) at 4 weeks , 1.13 ( 95 % CI 1.00 - 1.28 ) at 8 weeks and 1.21 ( 95 % CI 1.04 - 1.41 ) at 12 weeks post partum . In addition , when asked for an overall rating of their feeding experience , significantly fewer mothers in the peer support group than in the control group were dissatisfied ( 1.5 % v. 10.5 % ) ( p = 0.02 ) . Of the 130 mothers who evaluated the peer support intervention , 81.6 % were satisfied with their peer volunteer experience and 100 % felt that all new breast-feeding mothers should be offered this peer support intervention . INTERPRETATION The telephone-based peer support intervention was effective in maintaining breast-feeding to 3 months post partum and improving satisfaction with the infant feeding experience . The high satisfaction with and acceptance of the intervention indicates that breast-feeding peer support programs , in conjunction with professional health services , are effective",
"BACKGROUND For most smokers , quitting is a difficult process . Many smokers try to quit repeatedly before they succeed , with some relapsing even after a lengthy period of abstinence . Few population -based cohort studies have examined relapse among former smokers . Quantification of the relationship between the duration of abstinence and the likelihood of continued abstinence is important for the evaluation of ongoing public health interventions and the design of smoking-cessation programs . PURPOSE We analyzed longitudinal data from a large , representative population cohort of former smokers and estimated the probability of future relapse for different duration s of abstinence at baseline ( e.g. , 1 to 1990 California Tobacco Survey that used a r and om-digit-dialed computer-assisted telephone survey to interview 24296 California adults ( baseline interview ) from June 1990 through February 1991 , a stratified r and om sample of 4642 adults was reinterviewed from March 1992 through July 1992 . Both surveys assessed smoking status using st and ard questions about the lifetime use of 100 cigarettes and the self-classification of current smoking : 1 ) \" Have you smoked at least 100 cigarettes in your lifetime ? \" and 2 ) \" Do you smoke cigarettes now ? \" We included all 1449 former smokers at baseline interview who answered \" yes \" to the first question and \" no \" to the second and who also provided a valid date at both of the surveys when asked , \" When did you last smoke regularly ? \" All data were weighted to account for the study design and to ensure that the estimates were representative of the California population by age , sex , race/ethnicity , education , and geographic region . RESULTS Only about 12 % of the former smokers who had quit for less than 1 month at baseline remained continuously abstinent at the follow-up interview . This percentage increased to 25 % for those who had quit from 1 to less than 3 months ; it increased again to 52 % if the duration of quitting was from 3 to less than 6 months , but it increased only slightly to 59.2 % for those who had quit from 6 to less than 12 months . Overall , the likelihood of remaining continuously abstinent until the follow-up interview was about 90 % for former smokers who had quit for 3 months or longer and 95 % for those who had quit for 1 year or longer . CONCLUSIONS AND IMPLICATION S We suggest that self-reported cessation for more than 3 months be considered as an intermediate criterion for success both in longitudinal studies and the cross-sectional evaluation of community interventions . If a more stringent criterion is needed , we recommend self-reported cessation for at least 1 year",
"Background : Many believe that smoking cessation programmes for Latinos should be tailored to the values and beliefs of the culture . However , r and omised studies of culturally appropriate smoking cessation interventions with Latinos are rare . Methods : Latino smokers ( n = 313 ) were r and omised to an intervention condition or a comparison group . The intervention was a three month programme based on social cognitive constructs and delivered in the smoker ’s home by trained lay health advisors , or promotores . Comparison group participants were referred to the California Smoker ’s Helpline in Spanish . Predictors of abstinence among all participants also were examined . Results : About one week post-intervention , vali date d ( carbon monoxide ) past week abstinence rates were more than twice as high in the intervention group ( 20.5 % ) than in the comparison ( 8.7 % ) ( p ≤ 0.005 ) . The pattern of results held for self reported abstinence , and after recoding dropouts to non-abstinence . The primary predictor of abstinence was number of cigarettes smoked per day at baseline , a common measure of addiction . Conclusions : The culturally appropriate intervention facilitated abstinence in Latino smokers , at least in the short term . Strengths and weaknesses of the study are discussed",
"BACKGROUND Parents of children with chronic illnesses are at high risk for secondary mental health problems , such as anxiety and depression . OBJECTIVE To evaluate maternal outcomes of a support intervention for families of children with selected chronic illnesses . DESIGN A r and omized controlled clinical trial design with repeated measures 1 year apart . SETTING A community-based family support intervention linked to subspecialty and general pediatric clinics and practice s in a metropolitan area . PARTICIPANTS A population -based sample of 193 mothers of children aged 7 to 11 years ; the children were diagnosed as having diabetes , sickle cell anemia , cystic fibrosis , or moderate to severe asthma . About 15 % of the persons contacted refused to participate in the research , and 14 % of the families were lost to follow-up . INTERVENTION The 15-month intervention , the Family-to-Family Network , was design ed to enhance mothers ' mental health by linking mothers of school-aged children with selected chronic illnesses with mothers of older children with the same condition . The program included telephone contacts , face-to-face visits , and special family events . MAIN OUTCOME MEASURES Beck Depression Inventory score and the Psychiatric Symptom Index . RESULTS Maternal anxiety scores for participants in the experimental group decreased during the intervention period for all diagnostic groups and for the total group ; scores for the control group increased ( F = 5.07 , P = .03 ) . In multiple regression analyses , the intervention group was a significant predictor of posttest anxiety scores ( P = .03 ) . Effects were greater for mothers with high baseline anxiety ( P family support intervention can have beneficial effects on the mental health status of mothers of children with chronic illnesses . This type of intervention can be implemented in diverse pediatric setting",
"Context Obesity is a major public health problem in North America , particularly in Aboriginal people . Objective To determine if a household-based lifestyle intervention is effective at reducing energy intake and increasing physical activity among Aboriginal families after 6 months . Design , Participants , and InterventionR and omized , open trial of 57 Aboriginal households recruited between May 2004 and April 2005 from the Six Nations Reserve in Ohsweken , Canada . Aboriginal Health Counsellors made regular home visits to assist families in setting dietary and physical activity goals . Additional interventions included provision of filtered water , a physical activity program for children , and educational events about healthy lifestyles . Results 57 households involving 174 individuals were r and omized to intervention or usual care . Intervention households decreased consumption of fats , oils and sweets compared to usual care households ( -4.9 servings per day vs. -3 servings/day , p=0.006 ) , and this was associated with a reduction in trans fatty acids ( -0.2 vs. + 0.6 grams/day , p=0.02 ) . Water consumption increased ( + 0.3 vs. -0.1 servings/day , p soda pop consumption decreased ( -0.3 vs. -0.1 servings/day , p=0.02 ) in intervention households compared to usual care . A trend toward increased knowledge about healthy dietary practice s in children , increased leisure-time activity and decreased sedentary behaviours was observed , although these differences were not statistically significant . Conclusion A household-based intervention is associated with some positive changes in dietary practice s and activity patterns . A larger and longer-term intervention which addresses both individual change and structural barriers in the community is needed . Résumé Context eL’obésité est un problème de santé publique majeur en Amérique du Nord , particulièrement chez les Autochtones . ObjectifDéterminer si une intervention de modification du mode de vie centrée sur les ménages parvient à réduire l’apport énergétique et à accroître l’activité physique dans des familles autochtones au bout de six mois . Méthode , participants et interventionEssai ouvert aléatoire auprès de 57 ménages autochtones recrutés entre mai 2004 et avril 2005 dans la réserve des Six-Nations à Ohsweken ( Ontario ) , au Canada . Des conseillers en santé autochtone ont fait des visites à domicile périodiques pour aider les familles à se fixer des objectifs de saine alimentation et d’activité physique . D’autres mesures ont aussi été instaurées : on a fourni de l’eau filtrée aux ménages , offert un programme d’activité physique aux enfants et organisé des activités de sensibilisation aux modes de vie sains . RésultatsLes 57 ménages ( 174 personnes ) ont été répartis aléatoirement en deux groupes , l’un recevant les mesures d’intervention et l’autre , les soins habituels . Les ménages recevant les mesures d’intervention ont diminué leur consommation de matières grasses , d’huile et de sucreries par rapport aux ménages recevant les soins habituels ( -4,9 portions/jour contre -3 portions/jour , p=0,006 ) , et cette diminution était associée à une baisse de la consommation d’acides gras trans ( -0,2 contre + 0,6 g/jour , p=0,02 ) . Par ailleurs , leur consommation d’eau a augmenté ( + 0,3 contre -0,1 portion/jour , p consommation de boissons gazeuses a diminué ( -0,3 contre -0,1 portion/jour , p=0,02 ) . Nous avons aussi observé une amélioration des connaissances des enfants sur la saine alimentation , une augmentation de l’activité pendant les temps libres et une diminution des comportements sédentaires , mais ces changements n’étaient pas significatifs . Conclusion Une intervention centrée sur les ménages est associée à certains changements positifs dans l’alimentation et l’activité physique . Il faudrait élargir et prolonger l’initiative , en tenant compte à la fois des changements individuels et des obstacles structurels dans la communauté",
"PURPOSE We describe a controlled trial of a community outreach intervention to promote recognition , receipt , and screening-interval maintenance of clinical breast examinations ( CBE ) , mammograms , and Pap smears among Vietnamese-American women . METHODS Over a 3-year period , indigenous lay health workers conducted small-group sessions of Vietnamese women in a low-income district of San Francisco , California . Women in Sacramento , California , served as controls . Lay workers conducted 56 sessions on general prevention , 86 on cervical cancer , and 90 on breast cancer . Surveys of 306 to 373 women were conducted in the study communities in 1992 and 1996 . RESULTS In the intervention community , recognition of screening tests increased significantly between pre- and postintervention surveys : CBE , 50 to 85 % ; mammography , 59 to 79 % ; and Pap smear , 22 to 78 % ( P = 0.001 for all ) . Receipt of screening tests also increased significantly : CBE , 44 to 70 % ( P = 0.001 ) ; mammography , 54 to 69 % ( P = 0.006 ) ; and Pap smear , 46 to 66 % ( P = 0.001 ) . Best-fitting logistic regression models , adjusting for preintervention rates and significant covariates , also showed statistically significant odds ratios for the intervention effect ( P Vietnamese women 's recognition , receipt , and maintenance of breast and cervical cancer screening tests",
"BACKGROUND The 1998 UK government White Paper Smoking Kills emphasises that normal practice should be for general practitioners ( GPs ) , practice nurses , and others to offer advice and support to smokers in their efforts to stop . However , GPs are not allowed to write NHS prescriptions for nicotine-replacement therapy , even though this is the only effective pharmaceutical treatment available in the UK . We estimated the cost-effectiveness , for the NHS , of allowing GPs to prescribe transdermal nicotine patches for up to 12 weeks . METHODS We used data from a r and omised , placebo-controlled efficacy trial of nicotine patches and a survey of associated re source use in 30 GP surgeries in 15 English counties . We calculated the health benefit of nicotine-patch treatment in number of life years that would be saved by stopping smoking at various ages , and used an abstinence-contingent treatment model to calculate the incremental cost per life year saved by GP counselling with nicotine-patch treatment over GP counselling alone . Cost effectiveness was assessed on the basis that GPs would provide repeat NHS prescriptions for up to 12 weeks if the treatment was proving successful . FINDINGS If GPs were allowed to prescribe transdermal nicotine patches on the NHS , for up to 12 weeks , the incremental cost per life year saved would be : Pound Sterling 398 per person younger than 35 years ; Pound Sterling 345 for those aged 35 - 44 years ; Pound Sterling 432 for those aged 45 - 54 years ; and Pound Sterling 785 for those aged 55 - 65 years . INTERPRETATION The low cost per life year saved would make GP intervention against smoking a cost-effective life-saving treatment . The priniciples of the government White Paper could be cost-effectively extended into general practice to reduce smoking and smoking-related illnesses",
"BACKGROUND Reducing the impact of chronic disease in minority ethnic groups is an important public health challenge . Lay-led education may overcome cultural and language barriers that limit the effectiveness of professionally-led programmes . We report the first r and omised trial of a lay-led self-management programme - the Chronic Disease Self-Management Programme ( CDSMP ) ( Expert Patient Programme ) - in a south Asian group . AIM To determine the effectiveness of a culturally-adapted lay-led self-management programme for Bangladeshi adults with chronic disease . DESIGN OF STUDY R and omised controlled trial . SETTING Tower Hamlets , east London . METHOD We recruited Bangladeshi adults with diabetes , cardiovascular disease , respiratory disease or arthritis from general practice s and r and omised them to the CDSMP or waiting-list control . Self-efficacy ( primary outcome ) , self-management behaviour , communication with clinician , depression scores , and healthcare use were assessed by blinded interviewer-administered question naires in Sylheti before r and omisation and 4 months later . RESULTS Of the 1363 people invited , 476 ( 34 % ) agreed to take part and 92 % ( 439/476 ) of participants were followed up . The programme improved self-efficacy ( difference : 0.67 , 95 % confidence interval [ CI ] = 0.08 to 1.25 ) and self-management behaviour ( 0.53 ; 95 % CI = 0.01 to 1.06 ) . In the 51 % ( 121/238 ) of intervention participants attending three or more of the 6-weekly education sessions the programme led to greater improvements in self-efficacy ( 1.47 ; 95 % CI = 0.50 to 1.82 ) and self-management behaviour ( 1.16 ; 95 % CI = 0.50 to 1.82 ) , and reduced HADS depression scores ( 0.64 ; 95 % CI = 0.07 to 1.22 ) . Communication and healthcare use were not significantly different between groups . The programme cost pound123 ( 181 ) per participant . CONCLUSION A culturally-adapted CDSMP improves self-efficacy and self-care behaviour in Bangladeshi patients with chronic disease . Effects on health status were marginal . Benefits were limited by moderate uptake and attendance",
"BACKGROUND The Arizona Well-Integrated Screening and Evaluation for Women Across the Nation ( WISEWOMAN ) project used provider counseling , health education , and community health workers ( CHWs ) to target chronic disease risk factors in uninsured , primarily Hispanic women over age 50 . METHODS Participants were recruited from two Tucson clinics participating in the National Breast and Cervical Cancer Early Detection Program ( NBCCEDP ) . Women were r and omly assigned into one of three intervention groups : ( 1 ) provider counseling , ( 2 ) provider counseling and health education , or ( 3 ) provider counseling , health education , and CHW support . At baseline and 12 months ( 1998 - 2000 ) , participants were measured for height , weight , waist and hip circumference , and blood pressure . Blood tests were conducted to check blood glucose , cholesterol , and triglyceride levels . At each time point , participants also completed 24-hour dietary recalls and question naires focusing on their physical activity levels . RESULTS A total of 217 women participated in baseline and 12-month follow-up . Three fourths were Hispanic . All three intervention groups showed an increase in self-reported weekly minutes of moderate-to-vigorous physical activity , with no significant differences between the groups . Significantly more women who received the comprehensive intervention of provider counseling , health education , and CHW support progressed to eating five fruits and vegetables per day , compared with participants who received only provider counseling or provider counseling plus health education . CONCLUSIONS All three interventions increased moderate-to-vigorous physical activity but not fruit and vegetable consumption . The intervention group with provider counseling , health education , and CHW support significantly increased the number of women meeting national recommendations for fruit and vegetable consumption",
"A network-oriented HIV prevention intervention based on social identity theory and peer outreach was implemented for HIV positive and negative drug users . A community sample of 250 were r and omly assigned to an equal-attention control condition or a multisession , small-group experimental condition , which encouraged peer outreach ; 94 % of participants were African American , and 66 % used cocaine or opiates . At follow-up , 92 % of participants returned , and experimental compared with control group participants were 3 times more likely to report reduction of injection risk behaviors and 4 times more likely to report increased condom use with casual sex partners . Results suggest that psychosocial intervention emphasizing prosocial roles and social identity , and incorporating peer outreach strategies , can reduce HIV risk in low-income , drug-using communities",
"The Community Trial of Breast Cancer Screening Promotion assessed the effectiveness and cost-effectiveness of mammography promotion by community volunteer groups in rural areas using three different intervention approaches : individual counseling , community activities , and a combined intervention including both . Societal costs of the interventions were calculated and used in conjunction with measures of effectiveness to calculate cost-effectiveness in terms of cost per additional mammogram and cost per year of life saved . Methods of collecting and using cost information to assess the cost-effectiveness of community interventions are described . The Community Activities intervention was found to be the most cost-effective , at approximately $ 2,000 for each additional regular mammography user in the community . The cost per year of life saved associated with mammography promotion was approximately $ 56,000 per year of life saved . Exploratory analyses suggest that the most cost-effective method of promoting mammography use may vary with the target population",
"Objective : To assess the cost effectiveness of the Expert Patients Programme ( EPP ) intervention compared to a treatment as usual alternative . Design : Two-arm pragmatic r and omised controlled trial design with waiting list control . Setting : Community setting s in Engl and . Patients : Patients with a wide range of self-defined long-term conditions . Intervention : The EPP based on the US chronic disease self management program ( CDSMP ) , a lay-led self-care group involving six weekly sessions to teach self-care support skills . Main outcome measures : Costs estimated over a 6-month period from a societal perspective . Health outcomes estimated in terms of quality adjusted life years ( QALYs ) generated by patients ’ response to the EQ5D at baseline and 6-month follow-up . Results : The intervention group is associated with better patient outcomes , at slightly lower cost . Specifically , the intervention group has a 0.020 QALY gain compared with the control group , and a reduced cost of around £ 27 per patient . The intervention would therefore be considered dominant . While the QALYs gained are small in absolute terms , an additional 0.02 QALY is equivalent to an extra one week of perfect health per year . When the value of a QALY is £ 20 000 the EPP has a probability of 94 % of being cost effective . Indeed , for all plausible values of willingness-to-pay for a QALY the EPP group is more likely to be cost effective than the control group . Conclusions : The EPP intervention evaluated in this trial is very likely to provide a cost effective alternative to usual care in people with long-term conditions"
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Nighttime blood pressure strongly predicts cardiovascular events ( CVEs ) . Further , a preliminary trial has shown decreased CVEs from evening vs morning dosing of antihypertensive therapy . Is there additional evidence for evening dosing ? The authors systematic ally classified all hypertension trials as evening dosing trials ( EDTs ) or usual dosing trials ( UDTs ) . Meta-analyses provided st and ardized hazard ratios for CVEs for EDTs ( HREDT s ) and UDTs ( HRUDT s ) . HREDT s /HRUDT s gave the relative risk ( RR ) from evening vs usual dosing . Among 175 trials , 5 EDTs were discovered . The RR for CVEs ( 95 % confidence limits ) from evening vs usual dosing was 0.63 ( 0.43 - 0.92 ; P=.016 ) . After adjustment for drug class , the RR was 0.54 ( 0.34 - 0.85 ; P=.008 ) . Unlike other EDTs , the Heart Outcomes Prevention Evaluation ( HOPE ) study administered its entire antihypertensive dose prior to sleep and gave the greatest risk reduction . This study provides a third type of evidence suggesting a beneficial effect from evening dosing of antihypertensive therapy . Head-to-head , multicenter trials are needed to test this strategy
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"Therapeutic strategies in resistant hypertension include adding another drug or changing drugs in search for a better synergic combination . Most patients , however , receive all of their drugs in a single morning dose . We have evaluated the impact on the circadian pattern of blood pressure on modifying the time of treatment without increasing the number of prescribed drugs . We studied 250 hypertensive patients who were receiving 3 antihypertensive drugs in a single morning dose . Patients were r and omly assigned to 1 of 2 groups according to the modification in their treatment strategy : changing 1 of the drugs but keeping all 3 in the morning or the same approach but administering the new drug at bedtime . Blood pressure was measured for 48 hours before and after 12 weeks of treatment . There was no effect on ambulatory blood pressure when all of the drugs were taken on awakening . The baseline prevalence of nondipping ( 79 % ) was slightly increased after treatment ( 86 % ; P=0.131 ) . The ambulatory blood pressure reduction was statistically significant ( 9.4/6.0 mm Hg for systolic/diastolic blood pressure ; P reduction was larger in the nocturnal than in the diurnal mean of blood pressure . Thus , whereas only 16 % of the patients in this group were dippers at baseline , 57 % were dippers after therapy ( P blood pressure control and for the proper modeling of the circadian blood pressure pattern than just changing the drug combination",
"Several previous studies found that too great a reduction of clinic blood pressure ( BP ) by treatment increased cardiovascular disease ( CVD ) risk , whereas moderate reduction decreased it . Thus , it has been suggested that the relationship between BP and CVD events is J-shaped , with CVD risk decreasing as BP is lowered , and then rising as BP is further decreased . Correlation between BP level and CVD risk , however , is stronger for ambulatory BP monitoring ( ABPM ) than clinical BP measurements . We previously established that the hypertension treatment-time regimen , upon awakening versus at bedtime , exerts differential effect on BP control during the day and nighttime , which translates into a differential degree of CVD risk prevention . We , therefore , investigated the role of hypertension treatment-time scheme on the nature of the relationship between achieved clinic and ambulatory BP and CVD risk in the MAPEC ( Monitorización Ambulatoria para Predicción de Eventos Cardiovasculares , i.e. , Ambulatory Blood Pressure Monitoring for Prediction of Cardiovascular Events ) study , a prospect i ve , open-label , blinded-endpoint trial on 2156 hypertensive patients ( 1044 men/1112 women ) , 55.6 ± 13.6 ( mean ± SD ) yrs of age , r and omized to ingest all prescribed once-a-day hypertension medications upon awakening or the entire daily dose of ≥1 of them at bedtime . Ambulatory BP was measured for 48-h at baseline and annually thereafter , and more frequently ( quarterly ) when adjustment of treatment was necessary . After a median follow-up of 5.6 yrs , a J-shaped relationship was detected between total CVD events and clinic as well as awake BP mean , but only for the group of patients ingesting all medications upon awakening . The relationship was different in the group of patients who ingested ≥1 medications at bedtime ; the risk of CVD events progressively diminished in a linear , rather than J-shaped , manner with treatment-induced decrease in awake BP mean . The adjusted hazard ratio of CVD events was significantly lower with the progressive reduction in the asleep BP mean , independent of the hypertension treatment-time regimen . There was no single major event , i.e. , CVD death , myocardial infa rct ion , or stroke , in patients who achieved an asleep systolic BP mean that bedtime hypertension treatment is not associated with a J-shaped relationship between achieved BP and CVD risk . The decreased CVD risk associated with the progressive reduction in asleep BP , more feasible by bedtime than morning hypertension treatment , has clinical implication s , in particular , the need to consider the proper timing of hypertension medications , in conjunction with ABPM for proper assessment of BP control , as an improved and potentially safer means of reducing CVD risk of hypertensive patients . ( Author correspondence : [email protected]",
"CONTEXT Hypertensive patients are often given a calcium antagonist to reduce cardiovascular disease risk , but the benefit compared with other drug classes is controversial . OBJECTIVE To determine whether initial therapy with controlled-onset extended-release ( COER ) verapamil is equivalent to a physician 's choice of atenolol or hydrochlorothiazide in preventing cardiovascular disease . DESIGN , SETTING , AND PARTICIPANTS Double-blind , r and omized clinical trial conducted at 661 centers in 15 countries . A total of 16 602 participants diagnosed as having hypertension and who had 1 or more additional risk factors for cardiovascular disease were enrolled between September 1996 and December 1998 and followed up until December 31 , 2000 . After a mean of 3 years of follow-up , the sponsor closed the study before unblinding the results . INTERVENTION Initially , 8241 participants received 180 mg of COER verapamil and 8361 received either 50 mg of atenolol or 12.5 mg of hydrochlorothiazide . Other drugs ( eg , diuretic , beta-blocker , or an angiotensin-converting enzyme inhibitor ) could be added in specified sequence if needed . MAIN OUTCOME MEASURES First occurrence of stroke , myocardial infa rct ion , or cardiovascular disease-related death . RESULTS Systolic and diastolic blood pressure were reduced by 13.6 mm Hg and 7.8 mm Hg for participants assigned to the COER verapamil group and by 13.5 and 7.1 mm Hg for partcipants assigned to the atenolol or hydrochlorothiazide group . There were 364 primary cardiovascular disease-related events that occurred in the COER verapamil group vs 365 in atenolol or hydrochlorothiazide group ( hazard ratio [ HR ] , 1.02 ; 95 % confidence interval [ CI ] , 0.88 - 1.18 ; P = .77 ) . For fatal or nonfatal stroke , the HR was 1.15 ( 95 % CI , 0.90 - 1.48 ) ; for fatal or nonfatal myocardial infa rct ion , 0.82 ( 95 % CI , 0.65 - 1.03 ) ; and for cardiovascular disease-related death , 1.09 ( 95 % CI , 0.87 - 1.37 ) . The HR was 1.05 ( 95 % CI , 0.95 - 1.16 ) for any prespecified cardiovascular disease-related event and 1.08 ( 95 % CI , 0.93 - 1.26 ) for all-cause mortality . Nonstroke hemorrhage was more common with participants in the COER-verapamil group ( n = 118 ) compared with the atenolol or hydrochlorothiazide group ( n = 79 ) ( HR , 1.54 [ 95 % CI , 1.16 - 2.04 ] ; P = .003 ) . More cardiovascular disease-related events occurred between 6 AM and noon in both the COER verapamil ( 99/277 ) and atenolol or hydrochlorothiazide ( 88/274 ) groups ; HR , 1.15 ( 95 % CI , 0.86 - 1.53 ) . CONCLUSIONS The CONVINCE trial did not demonstrate equivalence of a COER verapamil-based antihypertensive regimen compared with a regimen beginning with a diuretic or beta-blocker . When considered in the context of other trials of calcium antagonists , these data indicate that the effectiveness of calcium-channel therapy in reducing cardiovascular disease is similar but not better than diuretic or beta-blocker treatment",
"OBJECTIVE ACE inhibitors and calcium antagonists may favorably affect serum lipids and glucose metabolism . The primary aim of the Fosinopril Versus Amlodipine Cardiovascular Events R and omized Trial ( FACET ) was to compare the effects of fosinopril and amlodipine on serum lipids and diabetes control in NIDDM patients with hypertension . Prospect ively defined cardiovascular events were assessed as secondary outcomes . RESEARCH DESIGN AND METHODS Inclusion criteria included a diagnosis of NIDDM and hypertension ( systolic blood pressure of > 140 mmHg or diastolic blood pressure of > 90 mmHg ) . Exclusion criteria included a history of coronary heart disease or stroke , serum creatinine > 1.5 mg/dl , albuminuria > 40 μg/min , and use of lipid-lowering drugs , aspirin , or antihypertensive agents other than beta-blockers or diuretics . A total of 380 hypertensive diabetics were r and omly assigned to open-label fosinopril ( 20 mg/day ) or amlodipine ( 10 mg/day ) and followed for up to 3.5 years . If blood pressure was not controlled , the other study drug was added . RESULTS Both treatments were effective in lowering blood pressure . At the end of followup , between the two groups there was no significant difference in total serum cholesterol , HDL cholesterol , HbA1c , fasting serum glucose , or plasma insulin . The patients receiving fosinopril had a significantly lower risk of the combined outcome of acute myocardial infa rct ion , stroke , or hospitalized angina than those receiving amlodipine ( 14/189 vs. 27/191 ; hazards ratio = 0.49 , 95 % CI = 0.26–0.95 ) . CONCLUSIONS Fosinopril and amlodipine had similar effects on biochemical measures , but the patients r and omized to fosinopril had a significantly lower risk of major vascular events , compared with the patients r and omized to amlodipine ",
"In the HOPE-trial , the ACE inhibitor ramipril significantly reduced cardiovascular morbidity and mortality in patients at high risk for cardiovascular events . The benefit could only partly be attributed to the modest mean reduction of office blood pressure ( OBP ) during the study period ( 3/2 mm Hg ) . However , because according to the HOPE protocol ramipril was given once daily at bedtime and blood pressure was measured during the day , the 24-hour reduction of blood pressure may be underestimated based on OBP . Thirty-eight patients with peripheral arterial disease enrolled in the HOPE study underwent 24-hour ambulatory blood pressure ( ABP ) measurement before r and omization and after 1 year . OBP was measured in the sitting position immediately before fitting the ABP measuring equipment to the patients . Ramipril did not significantly reduce OBP ( 8/2 mm Hg , P = NS ) or day ABP ( 6/2 mm Hg , P = NS ) after 1 year . Twenty-four – hour ABP was significantly reduced ( 10/4 mm Hg , P = 0.03 ) , mainly because of a more pronounced blood pressure lowering effect during nighttime ( 17/8 mm Hg , P The night/day ratio was also significantly lowered in the ramipril group . ABP shows greater falls , especially at night , than OBP during treatment with ramipril given once daily at bedtime . Although , OBP is the correct comparator when comparing with previous large intervention trials and epidemiological studies , the effects on cardiovascular morbidity and mortality seen with ramipril in the HOPE study may , to a larger extent than previously ascribed , relate to effects on blood pressure patterns over the 24-hour period",
"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",
"The reduction in blood pressure ( BP ) after the first dose and after 8 weeks of treatment with a new once-daily angiotensin converting enzyme ( ACE ) inhibitor , ramipril , was examined in 12 untreated hypertensive patients , using ambulatory intraarterial BP monitoring . The first period of monitoring began 24 hours before the first dose was given , and continued for 24 hours afterwards . A second 24-hour period of monitoring was carried out after 8 weeks of treatment , commencing immediately after the morning dose . Angiotensin II levels and serum drug levels were measured at 0 , 2 , 6 and 24 hours after the acute dose . BP decreased progressively from the first hour after the first dose , reached a maximum in the fifth hour ( p less than 0.001 ) and then the effect diminished . The maximum reduction of systolic BP in any patient was 64 mm Hg , the minimum 4 mm Hg . Blood pressure was significantly ( p less than 0.05 ) reduced throughout the 24 hours after dosing , with a mean daytime reduction of 13/12 mm Hg , and a mean nighttime reduction of 15/7 mm Hg . Angiotensin II levels were significantly ( p less than 0.02 ) and maximally reduced by 2 hours after administration , but the reduction was no longer significant after 24 hours . Serum drug levels were also maximal 2 hours after administration . The trial population could be clearly divided into groups of good and poor responders on the basis of BP reduction . The angiotensin II levels were higher before treatment , and decreased further , in all patients with a good response than in those with a poor response . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Clinical studies have documented morning-evening , administration-time differences of several different classes of hypertension medications in blood pressure (BP)-lowering efficacy , duration of action , safety profile , and /or effects on the circadian BP pattern . In spite of these published findings , most hypertensive subjects , including those under combination therapy , are instructed by their physicians and pharmacists to ingest all of their BP-lowering medications in the morning . The potential differential reduction of cardiovascular ( CVD ) morbidity and mortality risk by a bedtime versus upon-awakening treatment schedule has never been evaluated prospect ively . The prospect i ve MAPEC study was specifically design ed to test the hypothesis that bedtime chronotherapy with ≥1 hypertension medications exerts better BP control and CVD risk reduction than conventional therapy , i.e. , all medications ingested in the morning . A total of 2156 hypertensive subjects , 1044 men/1112 women , 55.6 ± 13.6 ( mean ± SD ) yrs of age , were r and omized to ingest all their prescribed hypertension medications upon awakening or ≥1 of them at bedtime . At baseline , BP was measured at 20-min intervals from 07:00 to 23:00 h and at 30-min intervals at night for 48 h. Physical activity was simultaneously monitored every min by wrist actigraphy to accurately determine the beginning and end of daytime activity and nocturnal sleep . Identical assessment was scheduled annually and more frequently ( quarterly ) if treatment adjustment was required . Despite lack of differences in ambulatory BP between groups at baseline , subjects ingesting medication at bedtime showed at their last available evaluation significantly lower mean sleep-time BP , higher sleep-time relative BP decline , reduced prevalence of non-dipping ( 34 % versus 62 % ; p .001 ) , and higher prevalence of controlled ambulatory BP ( 62 % versus 53 % ; p significantly lower relative risk of total CVD events than those ingesting all medications upon awakening ( 0.39 [ 0.29–0.51 ] ; number of events 187 versus 68 ; p groups in the relative risk of major events ( including CVD death , myocardial infa rct ion , ischemic stroke , and hemorrhagic stroke ) was also highly statistically significant ( 0.33 [ 0.19–0.55 ] ; number of events : 55 versus 18 ; p BP and increase in sleep-time relative BP decline towards a more normal dipping pattern , two novel therapeutic targets requiring proper patient evaluation by ambulatory BP , were best achieved with bedtime therapy , and they were the most significant predictors of event-free survival . Bedtime chronotherapy with ≥1 BP-lowering medications , compared to conventional upon-waking treatment with all medications , more effectively improved BP control , better decreased the prevalence of non-dipping , and , most importantly , significantly reduced CVD morbidity and mortality . ( Author correspondence : [email protected]",
"Background Isolated systolic hyprtension occurs in around 8 % of Chinese people aged 60 years or older . In 1988 , the Systolic Hypertension in China ( Syst-China ) Collaborative Group started to investigate whether active treatment could reduce the incidence of stroke and other cardiovascular complications in older patients with isolated systolic hypertension . Methods All patients were initially started on masked placebo . After stratification for centre , sex and previous cardiovascular complications , alternate patients ( n = 1253 ) were assigned nitrendipine at 10–40 mg daily , with the addition of captopril at 12.5–50.0 mg daily or hydrochlorothiazide at 12.5–50.0 mg daily , or both , if a sufficient blood pressure fall was not obtained . In the remaining 1141 control patients , matching placebos were administered similarly . Results At entry , sitting blood pressure averaged 170.5 mmHg systolic and 86.0 mmHg diastolic , age averaged 66.5 years and total serum cholesterol was 5.1 mmol/l . After 2 years of follow-up , sitting systolic and diastolic blood pressures had fallen by 10.9 mmHg and 1.9 mmHg in the placebo group and by 20.0 mmHg and 5.0 mmHg in the active treatment group . The intergroup differences were 9.1 mmHg systolic ( 95 % confidence interval 7.6–10.7 mmHg ) and 3.2 mmHg diastolic ( 95 % confidence interval 2.4–4.0 ) . Active treatment reduced total strokes by 38 % ( from 20.8 to 13.0 endpoints per 1000 patient-years , P = 0.01 ) , all-cause mortality by 39 % ( from 28.4 to 17.4 endpoints per 1000 patient-years , P = 0.003 ) , cardiovascular mortality by 39 % ( from 15.2 to 9.4 endpoints per 1000 patient-years , P = 0.03 ) , stroke mortality by 58 % ( from 6.9 to 2.9 endpoints per 1000 patient-years , P = 0.02 ) , and all fatal and nonfatal cardiovascular endpoints by 37 % ( from 33.3 to 21.4 endpoints per 1000 patient-years , P = 0.004 ) . Conclusions Antihypertensive treatment prevents stroke and other cardiovascular complications in older Chinese patients with isolated systolic hypertension . Treatment of 1000 Chinese patients for 5 years could prevent 55 deaths , 39 strokes or 59 major cardiovascular endpoints ",
"BACKGROUND Isolated systolic hypertension occurs in about 15 % of people aged 60 years or older . In 1989 , the European Working Party on High Blood Pressure in the Elderly investigated whether active treatment could reduce cardiovascular complications of isolated systolic hypertension . Fatal and non-fatal stroke combined was the primary endpoint . METHODS All patients ( > 60 years ) were initially started on masked placebo . At three run-in visits 1 month apart , their average sitting systolic blood pressure was 160 - 219 mm Hg with a diastolic blood pressure lower than 95 mm Hg . After stratification for centre , sex , and previous cardiovascular complications , 4695 patients were r and omly assigned to nitrendipine 10 - 40 mg daily , with the possible addition of enalapril 5 - 20 mg daily and hydrochlorothiazide 12.5 - 25.0 mg daily , or matching placebos . Patients withdrawing from double-blind treatment were still followed up . We compared occurrence of major endpoints by intention to treat . FINDINGS At a median of 2 years ' follow-up , sitting systolic and diastolic blood pressures had fallen by 13 mm Hg and 2 mm Hg in the placebo group ( n = 2297 ) and by 23 mm Hg and 7 mm Hg in the active treatment group ( n = 2398 ) . The between-group differences were systolic 10.1 mm Hg ( 95 % CI 8.8 - 11.4 ) and diastolic , 4.5 mm Hg ( 3.9 - 5.1 ) . Active treatment reduced the total rate of stroke from 13.7 to 7.9 endpoints per 1000 patient-years ( 42 % reduction ; p = 0.003 ) . Non-fatal stroke decreased by 44 % ( p = 0.007 ) . In the active treatment group , all fatal and non-fatal cardiac endpoints , including sudden death , declined by 26 % ( p = 0.03 ) . Non-fatal cardiac endpoints decreased by 33 % ( p = 0.03 ) and all fatal and non-fatal cardiovascular endpoints by 31 % ( p Cardiovascular mortality was slightly lower on active treatment ( -27 % , p = 0.07 ) , but all-cause mortality was not influenced ( -14 % ; p = 0.22 ) . INTERPRETATION Among elderly patients with isolated systolic hypertension , antihypertensive drug treatment starting with nitrendipine reduces the rate of cardiovascular complications . Treatment of 1000 patients for 5 years with this type of regimen may prevent 29 strokes or 53 major cardiovascular endpoints",
"ABCD : Appropriate Blood pressure Control in Diabetes ABI : ankle – brachial index ABPM : ambulatory blood pressure monitoring ACCESS : Acute C and esartan Cilexetil Therapy in Stroke Survival ACCOMPLISH : Avoiding Cardiovascular Events in Combination Therapy in Patients Living with Systolic Hypertension ACCORD : Action to Control Cardiovascular Risk in Diabetes ACE : angiotensin-converting enzyme ACTIVE I : Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events ADVANCE : Action in Diabetes and Vascular Disease : Preterax and Diamicron-MR Controlled Evaluation AHEAD : Action for HEAlth in Diabetes ALLHAT : Antihypertensive and Lipid-Lowering Treatment to Prevent Heart ATtack ALTITUDE : ALiskiren Trial In Type 2 Diabetes Using Cardio-renal Endpoints ANTIPAF : ANgioTensin II Antagonist In Paroxysmal Atrial Fibrillation APOLLO : A R and omized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People ARB : angiotensin receptor blocker ARIC : Atherosclerosis Risk In Communities ARR : aldosterone renin ratio ASCOT : Anglo-Sc and inavian Cardiac Outcomes Trial ASCOT-LLA : Anglo-Sc and inavian Cardiac Outcomes Trial — Lipid Lowering Arm ASTRAL : Angioplasty and STenting for Renal Artery Lesions A-V : atrioventricular BB : beta-blocker BMI : body mass index BP : blood pressure BSA : body surface area CA : calcium antagonist CABG : coronary artery bypass graft CAPPP : CAPtopril Prevention Project CAPRAF : C And esartan in the Prevention of Relapsing Atrial Fibrillation CHD : coronary heart disease CHHIPS : Controlling Hypertension and Hypertension Immediately Post-Stroke CKD : chronic kidney disease CKD-EPI : Chronic Kidney Disease — EPIdemiology collaboration CONVINCE : Controlled ONset Verapamil INvestigation of CV Endpoints CT : computed tomography CV : cardiovascular CVD : cardiovascular disease D : diuretic DASH : Dietary Approaches to Stop Hypertension DBP : diastolic blood pressure DCCT : Diabetes Control and Complications Study DIRECT : DIabetic REtinopathy C and esartan Trials DM : diabetes mellitus DPP-4 : dipeptidyl peptidase 4 EAS : European Atherosclerosis Society EASD : European Association for the Study of Diabetes ECG : electrocardiogram EF : ejection fraction eGFR : estimated glomerular filtration rate ELSA : European Lacidipine Study on Atherosclerosis ESC : European Society of Cardiology ESH : European Society of Hypertension ESRD : end-stage renal disease EXPLOR : Amlodipine – Valsartan Combination Decreases Central Systolic Blood Pressure more Effectively than the Amlodipine – Atenolol Combination FDA : U.S. Food and Drug Administration FEVER : Felodipine EVent Reduction study GISSI-AF : Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-Atrial Fibrillation HbA1c : glycated haemoglobin HBPM : home blood pressure monitoring HOPE : Heart Outcomes Prevention Evaluation HOT : Hypertension Optimal Treatment HRT : hormone replacement therapy HT : hypertension HYVET : HYpertension in the Very Elderly Trial IMT : intima-media thickness I-PRESERVE : Irbesartan in Heart Failure with Preserved Systolic Function INTERHEART : Effect of Potentially Modifiable Risk Factors associated with Myocardial Infa rct ion in 52 Countries INVEST : INternational VErapamil SR/T Tr and olapril ISH : Isolated systolic hypertension JNC : Joint National Committee JUPITER : Justification for the Use of Statins in Primary Prevention : an Intervention Trial Evaluating Rosuvastatin LAVi : left atrial volume index LIFE : Losartan Intervention For Endpoint Reduction in Hypertensives LV : left ventricle/left ventricular LVH : left ventricular hypertrophy LVM : left ventricular mass MDRD : Modification of Diet in Renal Disease MRFIT : Multiple Risk Factor Intervention Trial MRI : magnetic resonance imaging NORDIL : The Nordic Diltiazem Intervention study OC : oral contraceptive OD : organ damage ONTARGET : ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial PAD : peripheral artery disease PATHS : Prevention And Treatment of Hypertension Study PCI : percutaneous coronary intervention PPAR : peroxisome proliferator-activated receptor PREVEND : Prevention of REnal and Vascular ENdstage Disease PROFESS : Prevention Regimen for Effectively Avoiding Secondary Strokes PROGRESS : Perindopril Protection Against Recurrent Stroke Study PWV : pulse wave velocity QALY : Quality adjusted life years RAA : renin-angiotensin-aldosterone RAS : renin-angiotensin system RCT : r and omized controlled trials RF : risk factor ROADMAP : R and omized Olmesartan And Diabetes MicroAlbuminuria Prevention SBP : systolic blood pressure SCAST : Angiotensin-Receptor Blocker C and esartan for Treatment of Acute STroke SCOPE : Study on COgnition and Prognosis in the Elderly SCORE : Systematic COronary Risk Evaluation SHEP : Systolic Hypertension in the Elderly Program STOP : Swedish Trials in Old Patients with Hypertension STOP-2 : The second Swedish Trial in Old Patients with Hypertension SYSTCHINA : SYSTolic Hypertension in the Elderly : Chinese trial SYSTEUR : SYSTolic Hypertension in Europe TIA : transient ischaemic attack TOHP : Trials Of Hypertension Prevention TRANSCEND : Telmisartan R and omised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease UKPDS : United Kingdom Prospect i ve Diabetes Study VADT : Veterans ' Affairs Diabetes Trial VALUE : Valsartan Antihypertensive Long-term Use Evaluation WHO : World Health Organization # # # 1.1 Principles The 2013 guidelines on hypertension of the European Society of Hypertension ( ESH ) and the European Society of Cardiology",
"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"
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41174056-06ff-11f0-808a-c43d1ab1c353
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For young children with autism spectrum disorders , one of the choice interventions is Early Intensive Behavioral Intervention . Over the past ten years , its effectiveness has been abundantly evaluated based on various parameters , including the intensity and duration of the intervention . Despite major advances in effectiveness evaluation , data concerning the implementation of the intervention are often described briefly , and the active ingredients of the intervention are but rarely linked to the documented effects . OBJECTIVES This study aims at review ing with a systematic method , the studies pertaining to EIBI provided to children with autism spectrum disorders over the past ten years ( 2005 - 2015 ) and at documenting the program implementation components described in the studies , based on Dane and Schneider 's ( 1998 ) model in accordance with PRISMA guidelines . RESULTS The results show that , although the variables related to intervention dosage and protocol are relatively well described , the authors do not always consider them in the effects analysis . Furthermore , the majority of the studies did not report information on intervention participation , differentiation or quality . CONCLUSIONS Data concerning the implementation of the intervention are partially described in the articles retained . In this regard , a better description of the intervention provided and a more systematic evaluation of its implementation seem necessary to detect the subtle differences in the effects of the intervention
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[
"Preschoolers ( n = 118 ) with autism spectrum disorder ( ASD ) participated in this prospect i ve effectiveness study of an early intervention program . Treatment entailed parent training and therapist-implemented components , incorporating Pivotal Response Treatment and Positive Behaviour Support . St and ardized ability and behavioural measures were gathered prior to and following the 1-year intervention . Analyses were conducted for three groups based on baseline IQ : Higher IQ ( ≥70 ; n = 36 ) , Moderately Low IQ ( 40–69 ; n = 40 ) , and Very Low IQ ( Observed gains in key language and cognitive outcomes were significant for all groups . Baseline cognitive scores significantly predicted 1-year outcomes . Results are encouraging for this relatively low-intensity community-based intervention program",
"OBJECTIVE : To conduct a r and omized , controlled trial to evaluate the efficacy of the Early Start Denver Model ( ESDM ) , a comprehensive developmental behavioral intervention , for improving outcomes of toddlers diagnosed with autism spectrum disorder ( ASD ) . METHODS : Forty-eight children diagnosed with ASD between 18 and 30 months of age were r and omly assigned to 1 of 2 groups : ( 1 ) ESDM intervention , which is based on developmental and applied behavioral analytic principles and delivered by trained therapists and parents for 2 years ; or ( 2 ) referral to community providers for intervention commonly available in the community . RESULTS : Compared with children who received community-intervention , children who received ESDM showed significant improvements in IQ , adaptive behavior , and autism diagnosis . Two years after entering intervention , the ESDM group on average improved 17.6 st and ard score points ( 1 SD : 15 points ) compared with 7.0 points in the comparison group relative to baseline scores . The ESDM group maintained its rate of growth in adaptive behavior compared with a normative sample of typically developing children . In contrast , over the 2-year span , the comparison group showed greater delays in adaptive behavior . Children who received ESDM also were more likely to experience a change in diagnosis from autism to pervasive developmental disorder , not otherwise specified , than the comparison group . CONCLUSIONS : This is the first r and omized , controlled trial to demonstrate the efficacy of a comprehensive developmental behavioral intervention for toddlers with ASD for improving cognitive and adaptive behavior and reducing severity of ASD diagnosis . Results of this study underscore the importance of early detection of and intervention in autism",
"A recent study documented the efficacy of the Early Start Denver Model ( ESDM ) delivered in a 1:1 fashion . In the current study we investigated the effectiveness and feasibility of the ESDM in the context of a long-day care community service , with a child-staff ratio of 1:3 . Outcomes of 27 preschoolers with ASD undergoing 15–25 h per week of ESDM over 12 months were compared to those of 30 peers with ASD undergoing a different intervention program delivered in a similar community long-day care service . Children in both groups made gains in cognitive , adaptive and social skills . Participants in the ESDM group showed significantly higher gains in developmental rate and receptive language",
"Early intervention has been reported to improve outcome in children with autism spectrum disorders ( ASDs ) . Several studies in the field have been r and omized controlled trials ( RCTs ) . The aim of this study was to assess ASD outcome in a large naturalistic study . Two hundred and eight children , aged 20 - 54 months , with a clinical diagnosis of ASD were given intervention and monitored prospect ively in a naturalistic fashion over a period of 2 years . The toddlers were considered representative of all but the most severely multiple disabled preschool children with ASD in Stockholm county . They fell into three cognitive subgroups : one with learning disability , one with developmental delay , and one with normal intellectual functioning . Data on intervention type and intensity were gathered prospect ively in a systematic fashion . Intervention was classified into intensive applied behaviour analysis ( ABA ) and non-intensive , targeted interventions , also based on ABA principles . Children were comprehensively assessed by a research team before the onset of intervention , and then , again , 2 years later . Change in Vinel and adaptive behaviour scales composite scores from intake ( T1 ) to leaving the study ( T2 ) was set as the primary outcome variable . The research team remained blind to the type and intensity of interventions provided . One hundred and ninety-eight ( 95 % ) of the original sample s stayed in the study throughout the whole 2-year period and 192 children had a complete Vinel and composite score results both at T1 and T2 . Vinel and composite scores increased over the 2-year period . This increase was accounted for by the subgroup with normal cognitive functioning . There was no significant difference between the intensive and non-intensive groups . Individual variation was considerable , but no child in the study was \" problem-free \" at follow-up . Our data do not support that children with ASD generally benefit more from the most intensive ABA intervention programs than from less intensive interventions or targeted interventions based on ABA",
"OBJECTIVES The developmental disabilities questions in the 2014 National Health Interview Survey ( NHIS ) were changed from previous years , including question reordering and a new approach to asking about autism spectrum disorder ( ASD ) . This report examines survey-based estimates of the lifetime prevalence of ASD , intellectual disability ( ID ) , and any other developmental delay ( other DD ) following the inclusion of a st and alone ASD question , the inclusion of specific diagnoses in the ASD question , and the ASD question preceding the other DD question , and compares them with estimates from previous years . METHODS In NHIS , one child is r and omly selected from each family to be the subject of detailed questions on health conditions , functional limitations , and health care utilization . Parents are asked if a doctor or health professional had ever told them that their child had each of a series of developmental disabilities . Prevalence estimates of ASD , ID , and other DD for children aged 3–17 years were calculated using data collected in 2011–2014 . RESULTS The estimated prevalence of ASD based on 2014 data was 2.24 % , a significant increase from the estimated annualized prevalence of 1.25 % based on 2011–2013 data . In contrast , the prevalence of other DD declined significantly from 4.84 % based on 2011–2013 data to 3.57 % based on 2014 data . The prevalence of ID did not significantly change from 2011–2013 ( 1.27 % ) to 2014 ( 1.10 % ) . The prevalence of having any of the three conditions was constant across survey years . CONCLUSIONS The revised question ordering and new approach to asking about developmental disabilities in the 2014 NHIS likely affected the prevalence estimates of these conditions . In previous years , it is likely that some parents of children diagnosed with ASD reported this developmental disability as other DD instead of , or in addition to , ASD . Following these changes , the 2014 ASD estimate was more similar to ASD prevalence estimates from other sources",
"Twenty-four children with autism were r and omly assigned to a clinic-directed group , replicating the parameters of the early intensive behavioral treatment developed at UCLA , or to a parent-directed group that received intensive hours but less supervision by equally well-trained supervisors . Outcome after 4 years of treatment , including cognitive , language , adaptive , social , and academic measures , was similar for both groups . After combining groups , we found that 48 % of all children showed rapid learning , achieved average posttreatment scores , and at age 7 , were succeeding in regular education classrooms . Treatment outcome was best predicted by pretreatment imitation , language , and social responsiveness . These results are consistent with those reported by Lovaas and colleagues ( Lovaas , 1987 ; McEachin , Smith , & Lovaas , 1993 )",
"BACKGROUND This prospect i ve study compared outcome for pre-school children with autism spectrum disorders ( ASD ) receiving autism-specific nursery provision or home-based Early Intensive Behavioural Interventions ( EIBI ) in a community setting . METHODS Forty-four 23- to 53-month-old children with ASD participated ( 28 in EIBI home-based programmes ; 16 in autism-specific nurseries ) . Cognitive , language , play , adaptive behaviour skills and severity of autism were assessed at intake and 2 years later . RESULTS Both groups showed improvements in age equivalent scores but st and ard scores changed little over time . At follow-up , there were no significant group differences in cognitive ability , language , play or severity of autism . The only difference approaching significance ( p = .06 ) , in favour of the EIBI group , was for Vinel and Daily Living Skills st and ard scores . However , there were large individual differences in progress , with intake IQ and language level best predicting overall progress . CONCLUSIONS Home-based EIBI , as implemented in the community , and autism-specific nursery provision produced comparable outcomes after two years of intervention",
" An intervention group ( n=23 ) of preschool children with autism was identified on the basis of parent preference for early intensive behavioral intervention and a comparison group ( n=21 ) identified as receiving treatment as usual . Prospect i ve assessment was undertaken before treatment , after 1 year of treatment , and again after 2 years . Groups did not differ on assessment s at baseline but after 2 years , robust differences favoring intensive behavioral intervention were observed on measures of intelligence , language , daily living skills , positive social behavior , and a statistical measure of best outcome for individual children . Measures of parental well-being , obtained at the same three time points , produced no evidence that behavioral intervention created increased problems for either mothers or fathers of children receiving it",
"ABSTRACT . Although previous studies have shown favorable results with early intensive behavioral treatment ( EIBT ) for children with autism , it remains important to replicate these findings , particularly in community setting s. The authors conducted a 3-year prospect i ve outcome study that compared 2 groups : ( 1 ) 21 children who received 35 to 40 hours per week of EIBT from a community agency that replicated Lovaas ' model of EIBT and ( 2 ) 21 age- and IQ-matched children in special education classes at local public schools . A quasi-experimental design was used , with assignment to groups based on parental preference . Assessment s were conducted by independent examiners for IQ ( Bayley Scales of Infant Development or Wechsler Preschool and Primary Scales of Intelligence ) , language ( Reynell Developmental Language Scales ) , nonverbal skill ( Merrill-Palmer Scale of Mental Tests ) , and adaptive behavior ( Vinel and Adaptive Behavior Scales ) . Analyses of covariance , with baseline scores as covariates and Year 1 - 3 assessment s as repeated measures , revealed that , with treatment , the EIBT group obtained significantly higher IQ ( F = 5.21 , p = .03 ) and adaptive behavior scores ( F = 7.84 , p = .01 ) than did the comparison group . No difference between groups was found in either language comprehension ( F = 3.82 , p = .06 ) or nonverbal skill . Six of the 21 EIBT children were fully included into regular education without assistance at Year 3 , and 11 others were included with support ; in contrast , only 1 comparison child was placed primarily in regular education . Although the study was limited by the nonr and om assignment to groups , it does provide evidence that EIBT can be successfully implemented in a community setting",
"The Nova Scotia early intensive behavior intervention model -NS EIBI ( Bryson et al. , 2007 ) for children with autistic spectrum disorders was design ed to be feasible and sustainable in community setting s. It combines parent training and naturalistic one-to-one behavior intervention employing Pivotal Response Treatment - PRT ( R. Koegel & Koegel , 2006 ) . We followed 45 children ( 33 males , mean baseline age = 50 months ) for 12months . Mean gains of 14.9 and 19.5 months were observed on expressive and receptive language measures , respectively , for children with an IQ of 50 or more at baseline versus 6.1 and 8.4 months for children with IQs less than 50 . Behavior problems decreased significantly over the 1-year treatment for both groups , but autism symptoms decreased only for those with an IQ of 50 or more",
"Although early intensive behavior interventions have been efficient in producing positive behavior outcome in young children with Autism Spectrum Disorder , there is a considerable variety in the children 's progress . Research has suggested that parental and treatment factors are likely to affect children 's response to treatment . The purpose of the current study was to examine the interrelating factors that impact children 's progress , highlighting the influence of parent inclusion in treatment provision captured by parental stress , how faithfully the parents followed the treatment protocol s and the intensity of treatment provided at home . Twenty-four children received cross- setting staff- and parent-mediated EIBI , including continuous parent training and supervision . A comparison group of 20 children received eclectic intervention . St and ardized tests were carried out by independent examiners at intake and after six months . The intervention group outperformed the eclectic group in measures of autism severity , developmental and language skills . Parent training and constant parent-mediated treatment provision led to reduced challenging behaviors from the children , increased treatment fidelity and child direct behavior change as measured by performance in correct responding on behavior targets . Variables of treatment progress and potential predictors of child outcome were analyzed in detail and mapped with regard to their relationships drawn from multiple regression analysis . Particularly , the study highlights an association between parental stress and staff treatment fidelity that interferes with decision making in treatment planning and consequently with positive behavior outcome . Such results provide important scientific and clinical information on parental and treatment factors likely to affect a child 's response to treatment"
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41174092-06ff-11f0-808a-c43d1ab1c353
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Abstract This systematic review and meta- analysis of r and omized controlled trials ( RCTs ) was conducted to summarize the effect of resveratrol intake on weight loss . We search ed the following data bases until July 2018 : MEDLINE , EMBASE , Web of Science and Cochrane Central Register of Controlled Trials . Data were pooled using the inverse variance method and expressed as st and ardized mean difference ( SMD ) with 95 % confidence intervals ( 95 % CI ) . Out of 831 reports , 36 RCTs were eligible for including to our meta- analysis . The pooled results , using r and om-effects model showed that resveratrol supplementation significantly decreased body weight ( SMD = −0.17 ; 95 % CI , −0.33 , −0.01 ; P = 0.03 ; I2 : 62.6 ) , body mass index ( BMI ) ( SMD = −0.20 ; 95 % CI , −0.35 , −0.05 ; P = 0.01 ; I2 : 60.6 ) , fat mass ( SMD = −0.32 ; 95 % CI , −0.62 , −0.03 ; P = 0.03 ; I2 : 77.9 ) and waist circumference ( WC ) ( SMD = −0.42 ; 95 % CI , −0.68 , −0.16 ; P = 0.001 ; I2 : 75.2 ) , and significantly increased lean mass ( SMD = 1.21 ; 95 % CI , 0.75 , 1.67 ; P effect of resveratrol administration on leptin ( SMD = −0.20 ; 95 % CI , −0.68 , 0.27 ; P = 0.40 ; I2 : 85.3 ) and adiponectin levels ( SMD = 0.08 ; 95 % CI , −0.39 , 0.55 ; P = 0.74 ; I2 : 91.0 ) . Resveratrol supplementation significantly decreased body weight in obese patients ( SMD −0.43 ; 95 % CI , −0.60 , −0.26 ) compared with other diseases ( SMD 0.02 ; 95 % CI , −0.29 , 0.33 ) , and type 2 diabetes mellitus ( SMD −0.17 ; 95 % CI , −0.37 , 0.02 ) . Overall , the current meta- analysis demonstrated that resveratrol intake significantly reduced weight , BMI , WC and fat mass , and significantly increased lean mass , but did not affect leptin and adiponectin levels
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[
"Although resveratrol has widely been studied for its potential health benefits , little is known about its metabolic effects in humans . Our aims were to determine whether the polyphenol resveratrol improves insulin sensitivity in type 2 diabetic patients and to gain some insight into the mechanism of its action . After an initial general examination ( including blood chemistry ) , nineteen patients enrolled in the 4-week-long double-blind study were r and omly assigned into two groups : a resveratrol group receiving oral 2 × 5 mg resveratrol and a control group receiving placebo . Before and after the second and fourth weeks of the trial , insulin resistance/sensitivity , creatinine-normalised ortho-tyrosine level in urine sample s ( as a measure of oxidative stress ) , incretin levels and phosphorylated protein kinase B (pAkt):protein kinase B ( Akt ) ratio in platelets were assessed and statistically analysed . After the fourth week , resveratrol significantly decreased insulin resistance ( homeostasis model of assessment for insulin resistance ) and urinary ortho-tyrosine excretion , while it increased the pAkt : Akt ratio in platelets . On the other h and , it had no effect on parameters that relate to β-cell function ( i.e. homeostasis model of assessment of β-cell function ) . The present study shows for the first time that resveratrol improves insulin sensitivity in humans , which might be due to a resveratrol-induced decrease in oxidative stress that leads to a more efficient insulin signalling via the Akt pathway",
"BACKGROUND Obesity exacerbates the age-related decline in physical function and causes frailty in older adults ; however , the appropriate treatment for obese older adults is controversial . METHODS In this 1-year , r and omized , controlled trial , we evaluated the independent and combined effects of weight loss and exercise in 107 adults who were 65 years of age or older and obese . Participants were r and omly assigned to a control group , a weight-management ( diet ) group , an exercise group , or a weight-management-plus-exercise ( diet-exercise ) group . The primary outcome was the change in score on the modified Physical Performance Test . Secondary outcomes included other measures of frailty , body composition , bone mineral density , specific physical functions , and quality of life . RESULTS A total of 93 participants ( 87 % ) completed the study . In the intention-to-treat analysis , the score on the Physical Performance Test , in which higher scores indicate better physical status , increased more in the diet-exercise group than in the diet group or the exercise group ( increases from baseline of 21 % vs. 12 % and 15 % , respectively ) ; the scores in all three of those groups increased more than the scores in the control group ( in which the score increased by 1 % ) ( P peak oxygen consumption improved more in the diet-exercise group than in the diet group or the exercise group ( increases of 17 % vs. 10 % and 8 % , respectively ; P score on the Functional Status Question naire , in which higher scores indicate better physical function , increased more in the diet-exercise group than in the diet group ( increase of 10 % vs. 4 % , P Body weight decreased by 10 % in the diet group and by 9 % in the diet-exercise group , but did not decrease in the exercise group or the control group ( P Lean body mass and bone mineral density at the hip decreased less in the diet-exercise group than in the diet group ( reductions of 3 % and 1 % , respectively , in the diet-exercise group vs. reductions of 5 % and 3 % , respectively , in the diet group ; P Strength , balance , and gait improved consistently in the diet-exercise group ( P musculoskeletal injuries . CONCLUSIONS These findings suggest that a combination of weight loss and exercise provides greater improvement in physical function than either intervention alone . ( Funded by the National Institutes of Health ; Clinical Trials.gov number , NCT00146107 . )",
"Abstract Aims Oxidative stress plays a pivotal role in the pathogenesis of type 2 diabetes ( T2D ) . In vitro and animal studies have shown that resveratrol exerts an antioxidant effect , but clinical trials addressing this effect in patients with T2D are limited . The aim of this study was to determine whether resveratrol supplementation affects oxidative stress markers in a r and omized , placebo-controlled , double-blind clinical trial . Methods A total of 48 patients with T2D r and omly were assigned to receive 800 mg/day resveratrol or placebo for 2 months . Plasma total antioxidant capacity , malondialdehyde concentration , protein carbonyl and total thiol contents , intracellular superoxide anion ( O2− · ) and hydrogen peroxide ( H2O2 ) in P BMC s , the expression of genes involved in oxidative stress responses ( Nrf2 , SOD , Cat , HO-1 , RAGE , NOS ) in P BMC s , and metabolic and anthropometric parameters were measured at the baseline and at the trial end . Results Compared with the placebo group , resveratrol reduced plasma protein carbonyl content and P BMC s O2− · level and significantly increased plasma total antioxidant capacity and total thiol content . Furthermore , the expression of Nrf2 and SOD was significantly increased after resveratrol consumption . Resveratrol had no significant effects on the metabolic and anthropometric parameters except for a significant reduction in weight , BMI , and blood pressure levels . Resveratrol was well tolerated , and no serious adverse event was occurred . Conclusions Our study demonstrated that 8 weeks of supplementation with 800 mg/day resveratrol has an antioxidant effect in the blood and P BMC s of patients with T2D . Clinical Trial Registry number and website I RCT registration number : I RCT 2015072523336N1 and http://en . search .i rct .ir/view/24752",
"Introduction : The polyphenol resveratrol has been suggested to exert beneficial effects on memory and the aging hippocampus due to calorie‐restriction mimicking effects . However , the evidence based on human interventional studies is scarce . We therefore aim ed to determine the effects of resveratrol on memory performance , and to identify potential underlying mechanisms using a broad array of blood‐based biomarkers as well as hippocampus connectivity and microstructure assessed with ultra‐high field magnetic resonance imaging ( UHF‐MRI ) . Methods : In this double‐blind , r and omized controlled trial , 60 elderly participants ( 60–79 years ) with a wide body‐mass index ( BMI ) range of 21–37 kg/m2 were r and omized to receive either resveratrol ( 200mg/day ) or placebo for 26 weeks ( registered at Clinical Trials.gov : NCT02621554 ) . Baseline and follow‐up assessment s included the California Verbal Learning Task ( CVLT , main outcome ) , the ModBent task , anthropometry , markers of glucose and lipid metabolism , inflammation and neurotrophins derived from fasting blood , multimodal neuroimaging at 3 and 7 T , and question naires to assess confounding factors . Results : Multivariate repeated‐ measures ANOVA did not detect significant time by group effects for CVLT performance . There was a trend for preserved pattern recognition memory after resveratrol , while performance decreased in the placebo group ( n.s . , p=0.07 ) . Further exploratory analyses showed increases in both groups over time in body fat , cholesterol , fasting glucose , interleukin 6 , high sensitive C‐reactive protein , tumor necrosis factor alpha and in mean diffusivity of the subiculum and presubiculum , as well as decreases in physical activity , brain‐derived neurotrophic factor and insulin‐like growth factor 1at follow‐up , which were partly more pronounced after resveratrol . Discussion : This interventional study failed to show significant improvements in verbal memory after 6 months of resveratrol in healthy elderly with a wide BMI range . A non‐significant trend emerged for positive effects on pattern recognition memory , while possible confounding effects of unfavorable changes in lifestyle behavior , neurotrophins and inflammatory markers occurred . Our findings also indicate the feasibility to detect (un)healthy aging‐related changes in measures of hippocampus microstructure after 6 months using 7 T diffusion MRI . More studies incorporating a longer duration and larger sample size are needed to determine if resveratrol enhances memory performance in healthy older adults . HIGHLIGHTSIn this r and omized clinical trial , 6 months resveratrol supplementation showed no significant effects on verbal memory compared to placebo . Unfavorable changes in lifestyle factors at follow‐up might have introduced confounding . Secondary analyses showed a trend towards preserved pattern recognition . We used multimodal ultra high field MRI to detect subtle changes in microstructure of hippocampus subfields",
"We performed the largest r and omized , placebo‐controlled clinical trial to date ( N = 112 , 12‐week intervention ) to investigate the effects and safety of resveratrol supplementation on liver fat content and cardiometabolic risk parameters in overweight and obese and insulin‐resistant subjects . At baseline the variability in liver fat content was very large , ranging from 0.09 % to 37.55 % ( median , 7.12 % ; interquartile range , 3.85%‐12.94 % ) . Mean ( SD ) liver fat content was 9.22 ( 6.85 ) % in the placebo group and 9.91 ( 7.76 ) % in the resveratrol group . During the study liver fat content decreased in the placebo group ( −0.7 % ) but not in the resveratrol group ( −0.03 % ) ( differences between groups : P = .018 for the intention‐to‐treat [ ITT ] population ; N = 54 , resveratrol , N = 54 , placebo and P = .0077 for the per protocol [ PP ] population ) . No effects of resveratrol supplementation on cardiometabolic risk parameters were observed . Resveratrol supplementation was well tolerated and safe ",
"Nonalcoholic fatty liver disease ( NAFLD ) is the most common chronic liver disease in the world . Resveratrol is a polyphenolic compound with antioxidant capacity that shows beneficial effects on down-regulation of inflammatory mediators and metabolic disorders . We hypothesized that supplementation with resveratrol can further improve the efficacy of lifestyle modifications in the management of NAFLD . In this r and omized , double-blinded , controlled clinical trial , 50 NAFLD patients were supplemented with either a 500-mg resveratrol capsule or a placebo capsule for 12 weeks . Both groups were advised to follow an energy-balanced diet and received physical activity recommendations . Serum liver enzymes , inflammatory markers , hepatic steatosis and fibrosis , dietary intake , anthropometric measurements , and physical activity were assessed at both baseline and the end of the study . In both groups , anthropometric measurements ( weight , body mass index , waist circumference ) , liver enzymes , and steatosis grade improved ( P ) . Resveratrol supplementation was associated with a significant reduction in liver enzyme alanine aminotransferase , inflammatory cytokines , nuclear factor κB activity , serum cytokeratin-18 , and hepatic steatosis grade , as compared with placebo supplementation ( P resveratrol , along with lifestyle modification , is superior to lifestyle modification alone . This is at least partially due to the attenuation of inflammatory markers and hepatocellular apoptosis . More studies are needed to confirm and increase the clinical application of the present results",
"Ageing is thought to be associated with decreased vascular function partly due to oxidative stress . Resveratrol is a polyphenol , which in animal studies has been shown to decrease atherosclerosis , and improve cardiovascular health and physical capacity , in part through its effects on Sirtuin 1 signalling and through an improved antioxidant capacity . We tested the hypothesis that resveratrol supplementation enhances training-induced improvements in cardiovascular health parameters in aged men . Twenty-seven healthy physically inactive aged men ( age : 65 ± 1 years ; body mass index : 25.4 ± 0.7 kg m(-2 ) ; mean arterial pressure ( MAP ) : 95.8 ± 2.2 mmHg ; maximal oxygen uptake : 2488 ± 72 ml O2 min(-1 ) ) were r and omized into 8 weeks of either daily intake of either 250 mg trans-resveratrol ( n = 14 ) or of placebo ( n = 13 ) concomitant with high-intensity exercise training . Exercise training led to a 45 % greater ( P increase in maximal oxygen uptake in the placebo group than in the resveratrol group and to a decrease in MAP in the placebo group only ( -4.8 ± 1.7 mmHg ; P was lower in the resveratrol than in the placebo group after training ( 980 ± 90 vs. 1174 ± 121 pg ml(-1 ) ; P synthase was higher in the resveratrol group after training ( P administration also abolished the positive effects of exercise on low-density lipoprotein , total cholesterol/high-density lipoprotein ratio and triglyceride concentrations in blood ( P did not alter the effect of exercise training on the atherosclerosis marker vascular cell adhesion molecule 1 ( VCAM-1 ) . Sirtuin 1 protein levels were not affected by resveratrol supplementation . These findings indicate that , whereas exercise training effectively improves several cardiovascular health parameters in aged men , concomitant resveratrol supplementation can blunt these effects",
"Resveratrol is a naturally occurring polyphenolic compound . Numerous animal studies have been reported on its wide-ranging beneficial effects in the biological system including diabetes mellitus ( DM ) . We hypothesized , therefore , that oral supplementation of resveratrol would improve the glycemic control and the associated risk factors in patients with type 2 diabetes mellitus ( T2DM ) . The present clinical study was therefore carried out to test the hypothesis . Sixty-two patients with T2DM were enrolled from Government Headquarters Hospital , Ootacamund , India , in a prospect i ve , open-label , r and omized , controlled trial . Patients were r and omized into control and intervention groups . The control group received only oral hypoglycemic agents , whereas the intervention group received resveratrol ( 250 mg/d ) along with their oral hypoglycemic agents for a period of 3 months . Hemoglobin A(1c ) , lipid profile , urea nitrogen , creatinine , and protein were measured at the baseline and at the end of 3 months . The results reveal that supplementation of resveratrol for 3 months significantly improves the mean hemoglobin A(1c ) ( means ± SD , 9.99 ± 1.50 vs 9.65 ± 1.54 ; P ( mean ± SD , 139.71 ± 16.10 vs 127.92 ± 15.37 ; P ( mean ± SD , 4.70 ± 0.90 vs 4.33 ± 0.76 ; P ( mean ± SD , 75.6 ± 4.6 vs 72.3 ± 6.2 ; P No significant changes in body weight and high-density lipoprotein and low-density lipoprotein cholesterols were observed . Oral supplementation of resveratrol is thus found to be effective in improving glycemic control and may possibly provide a potential adjuvant for the treatment and management of diabetes",
"Background : Patients with schizophrenia ( SZ ) are generally overweight or obese and have several metabolic disorders . Additionally , such patients have a lower life expectancy and the main cause of their increased mortality is cardiovascular disease ( CVD ) . The objective of this study was to determine the efficacy of resveratrol supplementation on serum glucose and CVD risk factors in individuals with SZ . Methods and Results : This is a four-week r and omized , double-blind controlled trial ( registration No. : NCT 02062190 ) in which 19 men with a diagnosis of SZ , aged 18 to 65 , were assigned to either a resveratrol supplement group ( 200 mg/day ) or a placebo group ( 200 mg/day ) . In short , we did not observe significant changes after resveratrol supplementation . In the placebo group , we found a significant increase in total cholesterol levels ( p = 0.024 ) and in LDL-cholesterol ( p = 0.002 ) , as well as a decrease in body fat percentage ( p = 0.038 ) . The placebo group also showed an increase in triglycerides ( 9.19 % ) and a reduction in HDL-cholesterol ( 4.88 % ) . In the resveratrol group , triglycerides decreased ( 7.64 % ) . Conclusion : In summary , oral resveratrol in reasonably low dosages ( 200 mg daily ) brought no differences to body weight , waist circumference , glucose , and total cholesterol . It was possible to note that the lipid profile in the placebo group worsened and , although no significant differences were found , we can assume that resveratrol might prevent lipid profile damage and that the intervention affected the lipoprotein metabolism at various levels",
" Melinjo ( Gnetum gnemon L. ) seed extract ( MSE ) containing trans-resveratrol ( 3,5,4′-trihydroxy-trans-stilbene ) and other derivatives exerts various beneficial effects . However , its mechanism of action in humans remains unknown . In this study , we aim ed to investigate beneficial effects of MSE in healthy adult males . In this double-blind , r and omized controlled study , 30 males aged 35–70 years with ≤10 % flow-mediated dilatation received placebo or 750 mg MSE powder for 8 weeks , and twenty-nine males ( 45.1 ± 8.8 years old ) completed the trial . There was a significant difference in the melinjo and placebo groups . Compared with the placebo control , MSE significantly reduced serum uric acid at 4 weeks and 8 weeks ( n = 14 and 15 , resp . ) . HDL cholesterol was significantly increased in the melinjo group . To clarify the mechanism of MSE for reducing uric acid , we investigated xanthine oxidase inhibitory activity , angiotensin II type 1 ( AT1 ) receptor binding inhibition rate , and agonistic activities for PPARα and PPARγ . MSE , trans-resveratrol , and a resveratrol dimer , gnetin C ( GC ) , significantly inhibit AT1 receptor binding and exhibit mild agonistic activities for PPARα and PPARγ . In conclusion , MSE may decrease serum uric acid regardless of insulin resistance and may improve lipid metabolism by increasing HDL cholesterol",
"Resveratrol has been reported to have potent anti-atherosclerotic effects in animal studies . However , there are few interventional studies in human patients with atherosclerogenic diseases . The cardio-ankle vascular index ( CAVI ) reflects arterial stiffness and is a clinical surrogate marker of atherosclerosis . The aim of the present study was to investigate the effect of resveratrol on arterial stiffness assessed by CAVI in patients with type 2 diabetes mellitus (T2DM).In this double-blind , r and omized , placebo-controlled study , 50 patients with T2DM received supplement of a 100 mg resveratrol tablet ( total resveratrol : oligo-stilbene 27.97 mg/100 mg/day ) or placebo daily for 12 weeks . CAVI was assessed at baseline and the end of study . Body weight ( BW ) , blood pressure ( BP ) , glucose and lipid metabolic parameters , and diacron-reactive oxygen metabolites ( d-ROMs ; an oxidative stress marker ) were also measured . Resveratrol supplementation decreased systolic BP ( -5.5 ± 13.0 mmHg ) , d-ROMs ( -25.6 ± 41.8 U.CARR ) , and CAVI ( -0.4 ± 0.7 ) significantly ( P decreased BW ( -0.8 ± 2.1 kg , P = 0.083 ) and body mass index ( -0.5 ± 0.8 kg/m2 , P = 0.092 ) slightly compared to baseline , while there were no significant changes in the placebo group . Decreases in CAVI and d-ROMs were significantly greater in the resveratrol group than in the placebo group . Multivariate logistic regression analysis identified resveratrol supplementation as an independent predictor for a CAVI decrease of more than 0.5.In conclusion , 12-week resveratrol supplementation may improve arterial stiffness and reduce oxidative stress in patients with T2DM . Resveratrol may be beneficial in preventing the development of atherosclerosis induced by diabetes . However , a large-scale cohort study is required to vali date the present findings",
"Purpose The grape and wine polyphenol resveratrol exerts cardiovascular benefits but evidence from r and omized human clinical trials is very limited . We investigated dose-depending effects of a resveratrol-containing grape supplement on stable patients with coronary artery disease ( CAD ) treated according to currently accepted guidelines for secondary prevention of cardiovascular disease . Methods In a triple-blind , r and omized , placebo-controlled , one-year follow-up , 3-arm pilot clinical trial , 75 stable-CAD patients received 350 mg/day of placebo , resveratrol-containing grape extract ( grape phenolics plus 8 mg resveratrol ) or conventional grape extract lacking resveratrol during 6 months , and a double dose for the following 6 months . Changes in circulating inflammatory and fibrinolytic biomarkers were analyzed . Moreover , the transcriptional profiling of inflammatory genes in peripheral blood mononuclear cells ( P BMC s ) was explored using microarrays and functional gene expression analysis . Results After 1 year , in contrast to the placebo and conventional grape extract groups , the resveratrol-containing grape extract group showed an increase of the anti-inflammatory serum adiponectin ( 9.6 % , p = 0.01 ) and a decrease of the thrombogenic plasminogen activator inhibitor type 1 ( PAI-1 ) ( −18.6 % , p = 0.05 ) . In addition , 6 key inflammation-related transcription factors were predicted to be significantly activated or inhibited , with 27 extracellular-space acting genes involved in inflammation , cell migration and T-cell interaction signals presenting downregulation ( p No adverse effects were detected in relation to the study products . Conclusions Chronic daily consumption of a resveratrol-containing grape nutraceutical could exert cardiovascular benefits in stable-CAD patients treated according to current evidence -based st and ards , by increasing serum adiponectin , preventing PAI-1 increase and inhibiting atherothrombotic signals in P BMC",
"The objective of this study was to examine the effectiveness of resveratrol in lowering blood glucose in the presence of st and ard antidiabetic treatment in patients with type 2 diabetes , in a r and omized placebo-controlled double-blinded parallel clinical trial . A total of 66 subjects with type 2 diabetes were enrolled in this study and r and omly assigned to intervention group which was supplemented with resveratrol at a dose 1 g/day for 45 days and control group which received placebo tablets . Body weight , blood pressure , fasting blood glucose , haemoglobin A1c , insulin , homeostatic assessment s for insulin resistance , triglycerides , total cholesterol , low density lipoprotein , high density lipoprotein , and markers of liver and kidney damage were measured at baseline and after 45 days of resveratrol or placebo supplementation . Resveratrol treatment significantly decreased systolic blood pressure , fasting blood glucose , haemoglobin A1c , insulin , and insulin resistance , while HDL was significantly increased , when compared to their baseline levels . On the other h and , the placebo group had slightly increased fasting glucose and LDL when compared to their baseline levels . Liver and kidney function markers were unchanged in the intervention group . Overall , this study showed that resveratrol supplementation exerted strong antidiabetic effects in patients with type 2 diabetes",
"The polyphenol resveratrol is considered to exert many beneficial actions , such as antioxidant , anti-inflammatory , insulin-sensitizer and anticancer effects . Its benefits in patients with type 2 diabetes mellitus ( T2DM ) are controversial . Our aims were to determine whether resveratrol supplementation at two different dosages ( 500 and 40mg/day ) for 6 months i ) reduced the concentrations of C-reactive-protein ( CRP ) and ii ) ameliorated the metabolic pattern of T2DM patients . In the present double-blind , r and omized , placebo-controlled trial , 192 T2DM patients were r and omized to receive resveratrol 500mg/day ( Resv500arm ) , resveratrol 40mg/day ( Resv40arm ) or placebo for 6-months . At baseline and at the trial end , CRP values , anthropometric , metabolic and liver parameters were determined . No serious adverse event occurred . A dose-dependent , though not significant , CRP decrease of 5.6 % ( Resv40arm ) and 15.9 % ( Resv500arm ) was observed vs placebo . We failed to detect significant differences in weight , BMI , waist circumference , and values of arterial blood pressure , fasting glucose , glycated hemoglobin , insulin , C-peptide , free fatty acids , liver transaminases , uric acid , adiponectin , interleukin-6 , in both the Resv500 and Resv40 arms vs placebo . Total cholesterol and triglycerides slightly increased in the Resv500arm . Subgroup analyses revealed that lower diabetes duration ( in both Resv500 and Resv40arms ) , and , in the Resv500arm , younger age , aspirin use and being a smoker were associated with a significantly higher CRP reduction vs placebo . The supplementations with 40mg/day or 500mg/day resveratrol did neither reduce CRP concentrations , nor improve the metabolic pattern of T2DM patients",
"BACKGROUND The obese insulin-resistant state is characterized by impairments in lipid metabolism . We previously showed that 3-d supplementation of combined epigallocatechin-3-gallate and resveratrol ( EGCG+RES ) increased energy expenditure and improved the capacity to switch from fat toward carbohydrate oxidation with a high-fat mixed meal ( HFMM ) test in men . OBJECTIVE The present study aim ed to investigate the longer-term effect of EGCG+RES supplementation on metabolic profile , mitochondrial capacity , fat oxidation , lipolysis , and tissue-specific insulin sensitivity . DESIGN In this r and omized double-blind study , 38 overweight and obese subjects [ 18 men ; aged 38 ± 2 y ; body mass index ( kg/m(2 ) ) : 29.7 ± 0.5 ] received either EGCG+RES ( 282 and 80 mg/d , respectively ) or placebo for 12 wk . Before and after the intervention , oxidative capacity and gene expression were assessed in skeletal muscle . Fasting and postpr and ial ( HFMM ) lipid metabolism was assessed by using indirect calorimetry , blood sampling , and microdialysis . Tissue-specific insulin sensitivity was assessed by a hyperinsulinemic-euglycemic clamp with [6,6-(2)H2]-glucose infusion . RESULTS EGCG+RES supplementation did not affect the fasting plasma metabolic profile . Although whole-body fat mass was not affected , visceral adipose tissue mass tended to decrease after the intervention compared with placebo ( P-time × treatment = 0.09 ) . EGCG+RES supplementation significantly increased oxidative capacity in permeabilized muscle fibers ( P-time × treatment 0.05 , P-EGCG+RES 0.05 ) . Moreover , EGCG+RES reduced fasting ( P-time × treatment = 0.03 ) and postpr and ial respiratory quotient ( P-time × treatment = 0.01 ) compared with placebo . Fasting and postpr and ial fat oxidation was not significantly affected by EGCG+RES ( P-EGCG+RES = 0.46 and 0.38 , respectively ) but declined after placebo ( P-placebo = 0.05 and 0.03 , respectively ) . Energy expenditure was not altered ( P-time × treatment = 0.96 ) . Furthermore , EGCG+RES supplementation attenuated the increase in plasma triacylglycerol concentrations during the HFMM test that was observed after placebo ( P-time × treatment = 0.04 , P-placebo = 0.01 ) . Finally , EGCG+RES had no effect on insulin-stimulated glucose disposal , suppression of endogenous glucose production , or lipolysis . CONCLUSION Twelve weeks of EGCG+RES supplementation increased mitochondrial capacity and stimulated fat oxidation compared with placebo , but this did not translate into increased tissue-specific insulin sensitivity in overweight and obese subjects . This trial was registered at clinical trials.gov as NCT02381145",
"The search for complementary treatments in primary prevention of cardiovascular disease ( CVD ) is a high-priority challenge . Grape and wine polyphenol resveratrol confers CV benefits , in part by exerting anti-inflammatory effects . However , the evidence in human long-term clinical trials has yet to be established . We aim ed to investigate the effects of a dietary resveratrol-rich grape supplement on the inflammatory and fibrinolytic status of subjects at high risk of CVD and treated according to current guidelines for primary prevention of CVD . Seventy-five patients undergoing primary prevention of CVD participated in this triple-blinded , r and omized , parallel , dose-response , placebo-controlled , 1-year follow-up trial . Patients , allocated in 3 groups , consumed placebo ( maltodextrin ) , a resveratrol-rich grape supplement ( resveratrol 8 mg ) , or a conventional grape supplement lacking resveratrol , for the first 6 months and a double dose for the next 6 months . In contrast to placebo and conventional grape supplement , the resveratrol-rich grape supplement significantly decreased high-sensitivity C-reactive protein ( -26 % , p = 0.03 ) , tumor necrosis factor-α ( -19.8 % , p = 0.01 ) , plasminogen activator inhibitor type 1 ( -16.8 % , p = 0.03 ) , and interleukin-6/interleukin-10 ratio ( -24 % , p = 0.04 ) and increased anti-inflammatory interleukin-10 ( 19.8 % , p = 0.00 ) . Adiponectin ( 6.5 % , p = 0.07 ) and soluble intercellular adhesion molecule-1 ( -5.7 % , p = 0.06 ) tended to increase and decrease , respectively . No adverse effects were observed in any patient . In conclusion , 1-year consumption of a resveratrol-rich grape supplement improved the inflammatory and fibrinolytic status in patients who were on statins for primary prevention of CVD and at high CVD risk ( i.e. , with diabetes or hypercholesterolemia plus ≥1 other CV risk factor ) . Our results show for the first time that a dietary intervention with grape resveratrol could complement the gold st and ard therapy in the primary prevention of CVD",
"ABSTRACT Dietary polyphenols have beneficial effects on adipose tissue mass and function in rodents , but human studies are scarce . In a r and omized , placebo-controlled study , 25 ( 10 women ) overweight and obese humans received a combination of the polyphenols epigallocatechin-gallate and resveratrol ( 282 mg/d , 80 mg/d , respectively , EGCG+RES , n = 11 ) or placebo ( PLA , n = 14 ) supplementation for 12 weeks . Abdominal subcutaneous adipose tissue ( SAT ) biopsies were collected for assessment of adipocyte morphology and micro-array analysis . EGCG+RES had no effects on adipocyte size and distribution compared with PLA . However , we identified pathways contributing to adipogenesis , cell cycle and apoptosis were significantly downregulated by EGCG+RES versus PLA . Furthermore , EGCG+RES significantly decreased expression of pathways related to energy metabolism , oxidative stress , inflammation , and immune defense as compared with PLA . In conclusion , the SAT gene expression profile indicates a reduced cell turnover after 12-week EGCG+RES in overweight-obese subjects . It remains to be eluci date d whether these alterations translate into long-term metabolic effects",
"BACKGROUND & AIMS Nonalcoholic fatty liver disease ( NAFLD ) , characterized by accumulation of hepatic triglycerides ( steatosis ) , is associated with abdominal obesity , insulin resistance , and inflammation . Although weight loss via calorie restriction reduces features of NAFLD , there is no pharmacologic therapy . Resveratrol is a polyphenol that prevents high-energy diet-induced steatosis and insulin resistance in animals by up-regulating pathways that regulate energy metabolism . We performed a placebo-controlled trial to assess the effects of resveratrol in patients with NAFLD . METHODS Overweight or obese men diagnosed with NAFLD were recruited from hepatology outpatient clinics in Brisbane , Australia from 2011 through 2012 . They were r and omly assigned to groups given 3000 mg resveratrol ( n = 10 ) or placebo ( n = 10 ) daily for 8 weeks . Outcomes included insulin resistance ( assessed by the euglycemic-hyperinsulinemic clamp ) , hepatic steatosis , and abdominal fat distribution ( assessed by magnetic resonance spectroscopy and imaging ) . Plasma markers of inflammation , as well as metabolic , hepatic , and antioxidant function , were measured ; transcription of target genes was measured in peripheral blood mononuclear cells . Resveratrol pharmacokinetics and safety were assessed . RESULTS Eight-week administration of resveratrol did not reduce insulin resistance , steatosis , or abdominal fat distribution when compared with baseline . No change was observed in plasma lipids or antioxidant activity . Levels of alanine and aspartate aminotransferases increased significantly among patients in the resveratrol group until week 6 when compared with the placebo group . Resveratrol did not significantly alter transcription of NQO1 , PTP1B , IL6 , or HO1 in peripheral blood mononuclear cells . Resveratrol was well-tolerated . CONCLUSIONS Eight weeks administration of resveratrol did not significantly improve any features of NAFLD , compared with placebo , but it increased hepatic stress , based on observed increases in levels of liver enzymes . Further studies are needed to determine whether agents that are purported to mimic calorie restriction , such as resveratrol , are safe and effective for complications of obesity . Clinical trials registration no : ACTRN12612001135808",
"BACKGROUND Resveratrol have been shown to exert an antiinflammatory and antiaging effects in vitro and in animal models . OBJECTIVE The objective of the study was to investigate the effect of a Polygonum cuspidatum extract ( PCE ) containing resveratrol on oxidative and inflammatory stress in normal subjects . RESEARCH DESIGN AND METHODS Two groups ( 10 each ) of normal-weight healthy subjects were r and omized to placebo or PCE containing 40 mg resveratrol daily for 6 wk . Fasting blood sample s were obtained prior to and after treatment at 1 , 3 , and 6 wk . Mononuclear cells were prepared for reactive oxygen species generation , RNA isolation , nuclear extract , and total cell homogenate preparation . Indices of oxidative and inflammatory stress , suppressor of cytokine signaling-3 , phosphotyrosine phosphatase-1B , jun-N-terminal kinase-1 , and inhibitor of kappaB-kinase-beta were measured by RT-PCR and Western blotting . RESULTS The extract induced a significant reduction in reactive oxygen species generation , the expression of p47(phox ) , intranuclear nuclear factor-kappaB binding , and the expression of jun-N-terminal kinase-1 , inhibitor of kappaB-kinase-beta , phosphotyrosine phosphatase-1B , and suppressor of cytokine signaling-3 in mononuclear cells when compared with the baseline and the placebo . PCE intake also suppressed plasma concentrations of TNF-alpha , IL-6 , and C-reactive protein . There was no change in these indices in the control group given placebo . CONCLUSIONS The PCE-containing resveratrol has a comprehensive suppressive effect on oxidative and inflammatory stress",
"OBJECTIVE To evaluate the efficacy of an orlistat-resveratrol ( O-R ) combination in subjects with obesity over a 6-month period . METHODS This study was a double-blind , parallel , r and omized controlled clinical trial . Patients fulfilling the selection criteria ( age from 20 to 60 years and body mass index ( BMI ) ≥30 and ≤39.9 kg/m(2 ) ) consumed an energy-reduced diet with 500 fewer calories than their usual diet for 2 weeks . Then the participants were r and omly assigned to four groups , placebo , resveratrol , orlistat , or O-R , and they consumed the energy-reduced diet for 6 months . The study consisted of seven visits . During each visit , a 24-h recall was performed , along with measurements of anthropometric and serum biochemical parameters . RESULTS A total of 161 participants were selected . Of these , 84 participants completed the study . A significant weight loss of -6.82 kg ( 95 % CI -8.37 to -5.26 ) was observed in the O-R group compared with -3.50 kg ( -5.05 to -1.95 , P = 0.021 ) in the placebo group . In contrast , the -6.02 kg ( -7.68 to -4.36 ) orlistat and -4.68 kg ( -6.64 to -2.71 ) resveratrol monotherapy losses did not significantly differ from the placebo . Significant decreases in BMI , waist circumference , fat mass , triglycerides , leptin , and leptin/adiponectin ratio were observed with the O-R combination . CONCLUSIONS The O-R combination was the most effective weight loss treatment",
"Numerous studies have shown that resveratrol ( RES ) exerts anti-inflammatory effects but human trials evidencing these effects in vivo are limited . Furthermore , the molecular mechanisms triggered in humans following the oral intake of RES are not yet understood . Therefore , the purpose of this study was to investigate the molecular changes in peripheral blood mononuclear cells ( P BMC s ) associated to the one-year daily intake of a RES enriched ( 8 mg ) grape extract ( GE-RES ) in hypertensive male patients with type 2 diabetes mellitus ( T2DM ) . We used microarrays and RT-PCR to analyze expression changes in genes and microRNAs ( miRs ) involved in the inflammatory response modulated by the consumption of GE-RES in comparison to a placebo and GE lacking RES . We also examined the changes in several serobiochemical variables , inflammatory and fibrinolytic markers . Our results showed that supplementation with GE or GE-RES did not affect body weight , blood pressure , glucose , HbA1c or lipids , beyond the values regulated by gold st and ard medication in these patients . We did not find either any significant change on serum inflammatory markers except for a significant reduction of ALP and IL-6 levels . The expression of the pro-inflammatory cytokines CCL3 , IL-1β and TNF-α was significantly reduced and that of the transcriptional repressor LRRFIP-1 increased in P BMC s from patients taking the GE-RES extract . Also , a group of miRs involved in the regulation of the inflammatory response : miR-21 , miR-181b , miR-663 , miR-30c2 , miR-155 and miR-34a were found to be highly correlated and altered in the group consuming the GE-RES for 12 months . Our results provide preliminary evidence that long-term supplementation with a grape extract containing RES downregulates the expression of key pro-inflammatory cytokines with the involvement of inflammation-related miRs in circulating immune cells of T2DM hypertensive medicated patients and support a beneficial immunomodulatory effect in these patients",
"BACKGROUND Sirtuin 1 ( Sirt1 ) plays an important role in vascular biology , and influences aspects of age-dependent atherosclerosis . In animals , the sirtuin system is strongly influenced by resveratrol and caloric restriction , but its expression in humans is controversial . This study investigated the effects of resveratrol and caloric restriction on Sirt1 serum concentrations and vascular biomarkers in a healthy human population . METHODS AND RESULTS Forty-eight healthy participants ( 24 women ) aged 55 - 65years were r and omized to either 30days of resveratrol administration ( 500mg/day ) or caloric restriction ( 1000cal/day ) . Blood was collected at baseline and day 30 . Laboratory data analyzed were triglycerides , total cholesterol , HDL , VLDL , LDL , apolipoprotein A1 , apolipoprotein B , lipoprotein ( a ) , non-esterified fatty acids ( NEFA ) , glucose , insulin , oxidative stress , C-reactive protein , and Sirt1 . Expression of the Sirt1 gene was analyzed using real-time PCR . Caloric restriction diminished the abdominal circumference and improved the lipid profile , but not resveratrol intervention . Resveratrol and caloric restriction increased serum concentrations of Sirt1 , from 1.06±0.71 to 5.75±2.98ng/mL ; p respectively . Sirt1 increased in women and men in both interventions . On the other h and expression of Sirt1 mRNA was not different after caloric restriction and resveratrol treatment . CONCLUSIONS Caloric restriction and resveratrol significantly increased plasma concentrations of Sirt1 . The long-term impact of these interventions on atherosclerosis should be assessed",
"Background : We have previously demonstrated acute dose-dependent increases of flow-mediated dilatation ( FMD ) in the brachial artery after resveratrol consumption in mildly hypertensive , overweight/obese adults . Resveratrol supplementation has also been shown to increase cerebral blood flow acutely , without affecting cognition . Objectives : To evaluate the effects of chronic resveratrol supplementation on both FMD and cognitive performance . Method : Twenty-eight obese but otherwise healthy adults ( BMI : 33.3 ± 0.6 kg/m2 ) were r and omized to take a single 75 mg capsule of trans-resveratrol ( Resvida ) or placebo daily for 6 weeks each in a double-blind crossover supplementation trial . Blood pressure , arterial compliance , FMD , and performance on the Stroop Color-Word Test were assessed at the end of each 6-week intervention period while fasted and at least 18 h after taking the last daily capsule . An additional capsule of the same supplement was then taken . FMD assessment was repeated 1 h later . Results : Chronic resveratrol supplementation for 6 weeks was well tolerated and result ed in a 23 % increase in FMD compared with placebo ( P = 0.021 , paired t-test ) . The extent of increase correlated negatively with baseline FMD ( r = −0.47 , P = 0.01 ) . A single dose of resveratrol ( 75 mg ) following chronic resveratrol supplementation result ed in a 35 % greater acute FMD response than the equivalent placebo supplementation . These FMD improvements remained significant after adjusting for baseline FMD . Blood pressure , arterial compliance , and all components of the Stroop Color-Word Test were unaffected by chronic resveratrol supplementation . Conclusion : Daily resveratrol consumption was well tolerated and has the potential to maintain healthy circulatory function in obese adults",
"OBJECTIVES The primary aims of the study were to examine the effect of resveratrol on skeletal muscle SIRT1 expression and energy expenditure in subjects with Type 2 diabetes mellitus ( T2DM ) . BACKGROUND Animal and in vivo studies indicate that resveratrol increases SIRT1 expression that stimulates PGC1α activity . Subsequent upregulation of AMPK and GLUT4 expression are associated with improved insulin sensitivity in peripheral tissues . METHODS Ten subjects with T2DM were r and omized in a double-blind fashion to receive 3 g resveratrol or placebo daily for 12 weeks . Secondary outcomes include measures of AMPK , p-AMPK and GLUT4 expression levels , energy expenditure , physical activity levels , distribution of abdominal adipose tissue and skeletal muscle fiber type composition , body weight , HbA1c , plasma lipid subfraction , adiponectin levels , and insulin sensitivity . RESULTS There was a significant increase in both SIRT1 expression ( 2.01 vs. 0.86 arbitrary units [ AU ] , p = .016 ) and p-AMPK to AMPK expression ratio ( 2.04 vs. 0.79 AU , p = .032 ) in the resveratrol group compared with the placebo group . Although the percentage of absolute change ( 8.6 vs. -13.9 % , p = .033 ) and percentage of predicted resting metabolic rate ( RMR ; 7.8 vs. -13.9 % , p = .013 ) were increased following resveratrol , there was a significant reduction in average daily activity ( -38 vs. 43.2 % , p = .028 ) and step counts ( -39.5 vs. 11.8 % , p = .047 ) when compared with placebo . CONCLUSIONS In patients with T2DM , treatment with resveratrol regulates energy expenditure through increased skeletal muscle SIRT1 and AMPK expression . These findings indicate that resveratrol may have beneficial exercise-mimetic effects in patients with T2DM",
"Chronic low- grade inflammation is the hallmark of type 2 diabetes ( T2D ) . Although in vitro and animal studies have shown that resveratrol exerts anti-inflammatory effects , clinical trials addressing these effects in patients with T2D are limited . Therefore , in the present study , we hypothesized that supplementation of resveratrol might improve inflammatory markers in patients with T2D in a r and omized , double-blind , placebo-controlled clinical trial . A total of 45 T2D patients were supplemented with either of 800 mg/d resveratrol or placebo capsules for 8 weeks . Percentage of CD14+CD16 + monocytes , plasma levels of inflammatory cytokines ( tumor necrosis factor α , interleukin [ IL ] 1β , IL-6 , and monocyte chemoattractant protein-1 ) , the expression levels of genes involved in the inflammatory responses ( toll-like receptor 2 , toll-like receptor 4 , and nuclear factor κB ) , lipopolysaccharide-stimulated cytokine ( tumor necrosis factor α , IL-1β , and IL-6 ) secretion from peripheral blood mononuclear cells , and metabolic and anthropometric parameters were assessed at both the baseline level and the end of the study . Compared with the placebo group , we could not detect any significant difference in the percentage of CD14+CD16 + monocytes , lipopolysaccharide-induced cytokine secretion , plasma levels of inflammatory cytokines , and the expression of inflammatory genes in resveratrol group . Moreover , we did not find any significant change in the metabolic and anthropometric parameters except for a significant reduction in fasting blood glucose and blood pressure . In conclusion , 8-week supplementation of resveratrol reduces blood glucose level in patients with T2D without improving their inflammatory markers "
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Abstract Background In addition to regulating calcium homoeostasis and bone health , vitamin D influences vascular and metabolic processes including endothelial function ( EF ) and insulin signalling . This systematic review and meta- analysis of r and omised clinical trials ( RCTs ) were conducted to investigate the effect of vitamin D supplementation on EF and to examine whether the effect size was modified by health status , study duration , dose , route of vitamin D administration , vitamin D status ( baseline and post-intervention ) , body mass index ( BMI ) , age and type of vitamin D. Methods We search ed the Medline , Embase , Cochrane Library and Scopus data bases from inception until March 2015 for studies meeting the following criteria : ( 1 ) RCT with adult participants , ( 2 ) vitamin D administration alone , ( 3 ) studies that quantified EF using commonly applied methods including ultrasound , plethysmography , applanation tonometry and laser Doppler . Results Sixteen articles reporting data for 1177 participants were included . Study duration ranged from 4 to 52 weeks . The effect of vitamin D on EF was not significant ( SMD : 0.08 , 95 % CI −0.06 , 0.22 , p = 0.28 ) . Subgroup analysis showed a significant improvement of EF in diabetic subjects ( SMD : 0.31 , 95 % CI 0.05 , 0.57 , p = 0.02 ) . A non-significant trend was found for diastolic blood pressure ( β = 0.02 ; p = 0.07 ) and BMI ( β = 0.05 ; p = 0.06 ) . Conclusions Vitamin D supplementation did not improve EF . The significant effect of vitamin D in diabetics and a tendency for an association with BMI may indicate a role of excess adiposity and insulin resistance in modulating the effects of vitamin D on vascular function . This remains to be tested in future studies
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"OBJECTIVE In observational studies , low serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations have been associated with insulin resistance and other risk factors for cardiovascular disease . RESEARCH DESIGN AND METHODS We present 1-year data from an ongoing 5-year trial in 511 individuals with impaired fasting glucose ( IFG ) and /or impaired glucose tolerance ( IGT ) r and omly assigned to 20,000 IU/week vitamin D3 or placebo . An oral glucose tolerance test was performed at baseline and after 1 year . RESULTS Mean baseline serum 25(OH)D was 59.9 nmol/L and 61.1 nmol/L in the vitamin D and placebo groups , respectively , and increased by 45.8 nmol/L and 3.4 nmol/L , respectively . With adjustment for baseline concentrations , no differences in measures of glucose metabolism , insulin secretion or sensitivity , blood pressure , or hs-CRP were found after 1 year . There was a slight , but significant decrease in total and LDL cholesterol in the vitamin D group compared with the placebo group , but as there was also a decrease in HDL cholesterol , the change in the total/HDL cholesterol ratio did not differ significantly . Only analyzing subjects with 25(OH)D vitamin D supplementation does not improve glycemic indices , blood pressure , or lipid status in subjects with IFG and /or IGT ",
"BACKGROUND Studies suggest that vitamin D deficiency is a risk factor for cardiovascular disease and diabetes . Vitamin D deficiency is prevalent in HIV patients but the effect of vitamin D supplementation on cardiovascular risk in this population is unknown . METHODS We conducted a r and omized , double-blind , placebo-controlled trial among 45 HIV-infected adults in Clevel and ( OH , USA ) on stable antiretroviral therapy with durable virological suppression and a baseline serum 25-hydroxyvitamin D level of ≤20 ng/ml . Participants were r and omized 2:1 to vitamin D3 4,000 IU daily or placebo for 12 weeks . The primary outcome was a change in flow-mediated brachial artery dilation ( FMD ) . RESULTS Baseline demographics were similar except for age ( vitamin D versus placebo , mean ±sd 47 ±8 versus 40 ±10 years ; P=0.009 ) . Both groups had reduced FMD at baseline ( median values 2.9 % [ IQR 1.6 - 4.8 ] for vitamin D versus 2.5 % [ IQR 1.7 - 6.4 ] for placebo ; P=0.819 ) . Despite an increase in the concentration of serum 25-hydroxyvitamin D from baseline to 12 weeks ( 5.0 ng/ml [ IQR -0.9 - 7.4 ] versus -1.9 ng/ml [ IQR -4.0 - 0.1 ] for vitamin D versus placebo , respectively ; P=0.003 ) , there was no difference in FMD change ( 0.55 % [ IQR -1.05 - 2.13 ] versus 0.29 % [ IQR -1.61 - 1.77 ] ; P=0.748 ) . Vitamin D supplementation was associated with a decrease in total and non-high-density lipoprotein cholesterol , and an increase in indices of insulin resistance . CONCLUSIONS Among HIV-infected individuals with vitamin D deficiency , supplementation with 4,000 IU vitamin D3 daily for 12 weeks modestly improved vitamin D status and cholesterol but worsened insulin resistance without change in endothelial function . The mechanisms of resistance to st and ard doses of vitamin D and the complex role of vitamin D in glucose metabolism in this population require further investigation",
"OBJECTIVE Low vitamin D levels and risk factors for vascular disease are both common in South Asian women . This trial evaluated whether vitamin D supplementation could improve markers of vascular health in South Asian women with low 25-hydroxyvitamin D levels . METHODS Parallel-group , double-blind , r and omised placebo-controlled trial . Healthy South Asian women with baseline serum 25-hydroxyvitamin D levels of to receive a single dose of 100,000 units oral vitamin D3 or matching placebo . Outcomes were measured at baseline , 4 and 8 weeks . The primary outcome was change in endothelial function measured using brachial artery flow-mediated dilatation . Secondary outcomes included blood pressure , arterial stiffness , microvascular function measured using laser Doppler iontophoresis , insulin resistance , serum lipids , circulating markers of inflammation , thrombosis and adipokines . RESULTS 50 women were r and omised , 25 to each group . Mean age was 41 years ; mean baseline 25-hydroxyvitamin D level was 27 nmol/L. 25-Hydroxyvitamin D levels rose in the vitamin D group relative to the placebo group by 4 weeks ( 16 nmol/L , 95 % CI 11 to 21 , p flow-mediated dilatation in the vitamin D group relative to placebo at 4 weeks ( 0.1 % , 95 % CI -0.9 to 1.1 , p = 0.84 ) or 8 weeks ( 0.0 % , 95 % CI -1.4 to 1.4 , p = 0.98 ) . There was no improvement in cholesterol , insulin resistance or markers of inflammation . Both platelet activation inhibitor-1 and tissue plasminogen activator levels fell significantly in the vitamin D group relative to placebo at 8 weeks . CONCLUSION A single large dose of vitamin D3 did not improve blood pressure or endothelial function in South Asian women with low baseline 25-hydroxyvitamin D levels . TRIAL REGISTRATION IS RCT N75081811",
"BACKGROUND Low 25-hydroxy-vitamin D ( 25(OH)D ) levels are inversely related to blood pressure ( BP ) and have been associated with incident hypertension . In people living at northern latitudes diminished cholecalciferol synthesis in the winter increases the risk of vitamin D deficiency . We wanted to test the hypothesis that daily cholecalciferol supplementation in the winter lowers BP in patients with hypertension . METHODS We investigated the effect of 75 µg ( 3,000 IU ) cholecalciferol per day in a r and omized , placebo-controlled , double-blind study in 130 hypertensive patients residing in Denmark ( 56º N ) . Ambulatory BP ( 24-h BP ) and arterial stiffness were measured before and after 20 weeks of treatment , that took place between October and March . RESULTS A total of 112 patients ( mean age 61 ± 10 ) with a baseline p-25(OH)D of 23 ± 10 ng/ml completed the study . Compared with placebo , a nonsignificant 3/1 mm Hg ( P = 0.26/0.18 ) reduction was found in 24-h BP . In patients with vitamin D insufficiency ( 92 ) , 24-h BP decreased by 4/3 mm Hg ( P = 0.05/0.01 ) . Central BP ( CBP ) estimated by applanation tonometry and calibrated with a st and ardized office BP was reduced by 7/2 mm Hg ( P = 0.007/0.15 ) vs. placebo . No differences in carotid-femoral pulse wave velocity ( PWV ) or central augmentation index ( AIx ) were found between treatment arms . CONCLUSIONS Cholecalciferol supplementation , by a dose that effectively increased vitamin D levels , did not reduce 24-h BP , although central systolic BP decreased significantly . In a post-hoc subgroup analysis of 92 subjects with baseline p-25(OH)D levels decreases in 24-h systolic and diastolic BP occurred during cholecalciferol supplementation ",
"OBJECTIVE The purpose of this study was to prospect ively examine the association between vitamin D and calcium intake and risk of type 2 diabetes . RESEARCH DESIGN AND METHODS In the Nurses ' Health Study , we followed 83,779 women who had no history of diabetes , cardiovascular disease , or cancer at baseline for the development of type 2 diabetes . Vitamin D and calcium intake from diet and supplements was assessed every 2 - 4 years . During 20 years of follow-up , we documented 4,843 incident cases of type 2 diabetes . RESULTS After adjusting for multiple potential confounders , there was no association between total vitamin D intake and type 2 diabetes . However , the relative risk ( RR ) of type 2 diabetes was 0.87 ( 95 % CI 0.75 - 1.00 ; P for trend = 0.04 ) comparing the highest with the lowest category of vitamin D intake from supplements . The multivariate RRs of type 2 diabetes were 0.79 ( 0.70 - 0.90 ; P for trend calcium intake from all sources and 0.82 ( 0.72 - 0.92 ; P for trend 1,200 mg calcium and > 800 IU vitamin D was associated with a 33 % lower risk of type 2 diabetes with RR of 0.67 ( 0.49 - 0.90 ) compared with an intake of vitamin D and calcium intake in reducing the risk of type 2 diabetes",
"BACKGROUND Vitamin D and calcium metabolism are involved in vascular smooth muscle cell proliferation , endothelial function and blood pressure ( BP ) regulation . Their physiopathology has been a matter of intensive clinical investigation with variable and sometimes contradictory results . Vitamin D insufficiency is highly prevalent in the general population , particularly among the elderly . We evaluated the association between serum 25(OH)-D levels and arterial BP in this population . METHODS An epidemiological cross-sectional study was design ed to analyse the prevalence of hypovitaminosis D ( ' D'AVIS ' study ) in our reference area . The study was performed on a representative r and om sample of the population over 64 years of age obtained from five primary health care areas . A medical record , arterial BP and biological analysis : serum 25(OH)-D , iPTH , creatinine , urea , calcium , albumin were obtained . RESULTS A total of 237 subjects ( 53 % women ) , aged between 64 and 93 ( mean 71.7 + /- 5.3 ) , were evaluated . The mean serum 25(OH)-D levels were 17.21 + /- 7.57 ng/ml ( interval 5 - 54 ; 86 % had mean BP was 138.8 + /- 14/80 + /- 7.4 mmHg , and 46 % were on antihypertensive treatment . A significant negative association was observed between serum 25(OH)-D levels and systolic ( r = -0.153 , P = 0.018 ) and diastolic BP ( r = -0.152 , P = 0.019 ) . This association persisted after controlling for possible confounders in the multivariate analyses . CONCLUSIONS Low serum 25(OH)-D levels were inversely and independently associated with BP . Supplemental measures to prevent hypovitaminosis D in this population would be important , not only to protect the skeletal system but also for the possible beneficial effects on the cardiovascular system and the BP regulation",
"BACKGROUND AND AIMS Low vitamin D levels are associated with increased incidence of future cardiovascular events and are common in stroke patients . We tested whether vitamin D supplementation could reduce blood pressure and improve markers of vascular health in patients who had previously suffered a stroke . METHODS AND RESULTS R and omised , placebo-controlled , double-blind trial . Community-dwelling patients with a history of stroke and baseline 25-hydroxyvitamin D levels received 100,000 units of oral vitamin D2 or placebo at baseline . Office and 24 h blood pressure , endothelial function measured by flow-mediated dilatation of the brachial artery , cholesterol , oxidised low density lipoprotein , B-type natriuretic peptide and heart rate turbulence were measured at baseline , 8 weeks and 16 weeks . 58 patients were r and omised . Mean age was 67 years , mean baseline blood pressure 128/72 mmHg , mean baseline 25-hydroxyvitamin D level was 38 nmol/L. Serum 25-hydroxyvitamin D levels were higher in the intervention group at 8 weeks compared to placebo ( 54 vs 42 nmol/L , P = 0.002 ) and remained higher at 16 weeks . Office systolic and diastolic blood pressure showed no significant change between groups at 8 weeks ( systolic 126.1 vs 131.3 mmHg ; adjusted P = 0.97 ) ; ( diastolic 73.1 vs 74.9 mmHg , adjusted P = 0.15 ) . Flow mediated dilatation was significantly higher in the intervention group at 8 weeks ( 6.9 % vs 3.7 % , adjusted P = 0.007 ) but was not significantly different at 16 weeks . CONCLUSIONS High dose oral vitamin D supplementation did not improve blood pressure but produced short-term improvement in endothelial function in stroke patients with well-controlled baseline blood pressure . CLINICAL TRIALS REGISTRATION IS RCT N28737567",
"IMPORTANCE Observational data link low 25-hydroxyvitamin D levels to both prevalent blood pressure and incident hypertension . No clinical trial has yet examined the effect of vitamin D supplementation in isolated systolic hypertension , the most common pattern of hypertension in older people . OBJECTIVE To test whether high-dose , intermittent cholecalciferol supplementation lowers blood pressure in older patients with isolated systolic hypertension . DESIGN Parallel group , double-blind , placebo-controlled r and omized trial . SETTING Primary care clinics and hospital clinics . PARTICIPANTS Patients 70 years and older with isolated systolic hypertension ( supine systolic blood pressure > 140 mm Hg and supine diastolic blood pressure INTERVENTIONS A total of 100,000 U of oral cholecalciferol or matching placebo every 3 months for 1 year . MAIN OUTCOMES AND MEASURES Difference in office blood pressure , 24-hour blood pressure , arterial stiffness , endothelial function , cholesterol level , insulin resistance , and b-type natriuretic peptide level during 12 months . RESULTS A total of 159 participants were r and omized ( mean age , 77 years ) . Mean baseline office systolic blood pressure was 163/78 mm Hg . Mean baseline 25-hydroxyvitamin D level was 18 ng/mL. 25-Hydroxyvitamin D levels increased in the treatment group compared with the placebo group ( + 8 ng/mL at 1 year , P ) office blood pressure ( −1 [ −6 to 4]/−2 [ −4 to 1 ] mm Hg at 3 months and 1 [ −2 to 4]/0 [ −2 to 2 ] mm Hg overall treatment effect ) . No significant treatment effect was evident for any of the secondary outcomes ( 24-hour blood pressure , arterial stiffness , endothelial function , cholesterol level , glucose level , and walking distance ) . There was no excess of adverse events in the treatment group , and the total number of falls was nonsignificantly lower in the group receiving vitamin D ( 36 vs 46 , P = .24 ) . CONCLUSIONS AND RELEVANCE Vitamin D supplementation did not improve blood pressure or markers of vascular health in older patients with isolated systolic hypertension . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N92186858",
"BACKGROUND Low vitamin D levels are common , and are associated with a higher incidence of future vascular events . We tested whether vitamin D supplementation could improve endothelial function and other markers of vascular function in patients with a history of myocardial infa rct ion . METHODS Parallel group , placebo-controlled , double-blind r and omised trial . Patients with a history of myocardial infa rct ion were r and omised to receive 100,000 units of oral vitamin D3 or placebo at baseline , 2 months and 4 months . Outcomes were measured at baseline , 2 and 6 months . Reactive hyperaemia index on fingertip plethysmography was the primary outcome . Secondary outcome measures included blood pressure , cholesterol , C-reactive protein , von Willebr and factor , tumour necrosis factor alpha , E-selectin , B-type natriuretic peptide , thrombomodulin and 25-hydroxyvitamin D levels . RESULTS 75 patients were r and omised , mean age 66 years . 74/75 ( 99 % ) completed 6 month follow-up . 25 hydroxyvitamin D levels increased in the intervention group relative to placebo ( + 13 vs + 1 nmol/L , p=0.04 ) . There was no between-group difference in change in reactive hyperaemia index between baseline and 6 months ( -0.18 vs -0.07 , p=0.40 ) . Of the secondary outcomes , only C-reactive protein showed a significant decline in the intervention arm relative to placebo at 6 months ( -1.3 vs 2.0mg/L , p=0.03 ) . Systolic blood pressure ( + 1.4 vs + 2.3 mmHg , p=0.79 ) , diastolic blood pressure ( + 2.0 vs + 0.8 mmHg , p=0.54 ) and total cholesterol ( + 0.26 vs + 0.24 mmol/L , p=0.88 ) showed no between-group difference at 6 months . CONCLUSIONS Supplementation with vitamin D did not improve markers of vascular function in patients with a history of myocardial infa rct ion",
" BACKGROUND AND OBJECTIVES Observational studies suggest that calciferol supplementation may improve laboratory and patient-level outcomes of hemodialysis patients with reduced 25-hydroxyvitamin D [ 25(OH)D ] levels . This r and omized controlled trial examined effects of cholecalciferol supplementation in patients on hemodialysis . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS Sixty patients with 25(OH)D levels ≤24 ng/ml ( ≤60 nmol/L ) were r and omized to receive 50,000 IU oral cholecalciferol or placebo , once weekly for 8 weeks and then monthly for 4 months . At baseline ( autumn 2011 ) and 6 months , testing evaluated muscle strength , functional capacity , laboratory parameters , pulse wave velocity ( PWV ) , and health-related quality of life ( HRQOL ) using the Kidney Disease Quality of Life-36 survey . RESULTS Patients were well matched by treatment allocation . Median age was 62 years ( range , 20 - 86 ) , 52 % were women , 55 % had a history of diabetes , and mean serum 25(OH)D was 17±5 ng/ml ( 43±13 nmol/L ) . Patients were assessed over 6 months by repeated- measures ANOVA . Patients allocated to cholecalciferol had significantly higher values of 25(OH)D ( P ) , 1,25-dihydroxyvitamin D ( P=0.04 ) , and tartrate-resistant acid phosphatase-5b ) ( P=0.04 ) and a greater reduction in phosphorus values ( P=0.03 ) than placebo-treated patients Values of serum calcium , intact parathyroid hormone , and episodes of hypercalcemia and hyperphosphatemia did not differ significantly between the groups . No significant differences were detected in muscle strength , functional capacity , PWV , or HRQOL . CONCLUSIONS In this r and omized controlled trial , patients supplemented with cholecalciferol had higher 25(OH)D , 1,25-dihydroxyvitamin D , and tartrate-resistant acid phosphatase-5b levels , without increased calcium or phosphorus values . However , no effects were detected in muscle strength , functional capacity , PWV , or HRQOL ",
"BACKGROUND Suboptimal vitamin D status is associated with endothelial dysfunction and an increased risk of cardiovascular diseases but it is unclear whether vitamin D supplementation is beneficial . The aim was to investigate the effect of vitamin D supplementation on endothelial function in patients with type 2 diabetes mellitus ( DM ) . METHODS In a double-blind , placebo-controlled trial , we r and omized 100 type 2 DM patients to vitamin D supplement ( 5000 IU/day , n = 50 ) or placebo ( controls , n = 50 ) for 12 weeks . Assessment of vascular function with brachial artery flow-mediated dilatation ( FMD ) , circulating levels of endothelial progenitor cells ( EPCs ) and brachial-ankle pulse wave velocity , and metabolic parameter , high-sensitivity C-reactive protein ( hsCRP ) and oxidative stress markers were performed before and after the supplementation . RESULTS After 12 weeks , vitamin D treated patients had significant increases in serum 25-hydroxyvitamin D [ 25(OH)D ] concentration ( treatment effect 34.7 ng/mL , 95 % CI 26.4 - 42.9 , P serum ionized calcium ( treatment effect 0.037 mmol/L , 95 % CI 0.007 - 0.067 , P = 0.018 ) ; decreased serum parathyroid hormone concentration ( treatment effect -0.55 pmol/L , 95 % CI -1.08 to -0.02 , P = 0.042 ) compared to patients who received placebo . Nevertheless , vitamin D supplementation did not improve vascular function as determined by FMD , circulating EPC count or baPWV ( all P > 0.05 ) . Furthermore , hsCRP , oxidative stress markers , low- and high-density lipoprotein and glycated hemoglobin were also similar between two groups ( all P > 0.05 ) . CONCLUSION In patients with type 2 DM , 12 weeks oral supplementation of vitamin D did not significantly affect vascular function or serum biomarkers of inflammation and oxidative stress . CLINICAL TRIAL NUMBER HKCTR-867 , www.hk clinical trials.com",
"BACKGROUND Hypovitaminosis D is common in chronic kidney disease ( CKD ) . Effects of 25-hydroxyvitamin D replenishment in CKD are not well described . METHODS An 8-week r and omized , placebo-controlled , double-blind parallel intervention study was conducted in haemodialysis ( HD ) and non-HD CKD patients . Treatment consisted of 40,000 IU of cholecalciferol orally per week . Plasma 25-hydroxyvitamin D ( 25-OHD ) , plasma 1,25-dihydroxyvitamin D ( 1,25-diOHD ) , plasma parathyroid hormone ( PTH ) , serum phosphate , ionized serum calcium and serum fibroblast growth factor 23 ( FGF-23 ) were analysed . We also investigated biomarkers related to cardiovascular disease ( plasma D-dimer , plasma fibrinogen , plasma von Willebr and factor antigen and activity , plasma interleukin 6 , plasma C-reactive protein , blood pressure , aortic augmentation index , aortic pulse wave velocity and 24-h urinary protein loss ) . Objective and subjective health variables were assessed ( muscle function tests , visual analogue scores and Health Assessment Question naire ) . RESULTS Fifty-two CKD patients with 25-OHD Cholecalciferol supplementation led to a significant increase to a median of 155 nmol/L 25-OHD ( interquartile range 137 - 173 nmol/L ) in treated patients ( n = 25 , P 1,25-diOHD ( n = 13 , P lowering of PTH ( n = 13 , P in HD patients . Cholecalciferol supplementation caused a significant increase in serum calcium and FGF-23 . CONCLUSIONS 25-OHD replenishment was effectively obtained with the employed cholecalciferol dosing . In non-HD patients , it had favourable effects on 1,25-diOHD and PTH . Vitamin D-supplemented patients must be monitored for hypercalcaemia . The present study could not identify significant pleiotropic effects of 25-OHD replenishment",
"BACKGROUND A growing body of evidence has linked vitamin D deficiency to increased risk of cardiovascular disease . Vitamin D deficiency is also more common in African Americans for whom an increased cardiovascular disease risk exists . This study sought to test the hypothesis that 16 weeks of 60,000 IU monthly supplementation of oral vitamin D(3 ) would improve flow-mediated dilation ( FMD ) in African Americans , whereas no change would be observed in the placebo group . METHODS A r and omized , double-blind , placebo-controlled clinical trial was conducted . Fifty-seven African-American adults were r and omly assigned to either the placebo group or vitamin D group . RESULTS Following 16 weeks of placebo ( n = 23 ; mean age 31 ± 2 years ) or 60,000 IU monthly oral vitamin D(3 ) ( n = 22 ; mean age 29 ± 2 years ) , serum concentrations of 25-hydroxyvitamin D ( 25(OH)D ) increased from 38.2 ± 3.0 to 48.7 ± 3.2 nmol/l and 34.3 ± 2.2 to 100.9 ± 6.6 nmol/l , respectively . No changes in serum parathyroid hormone ( PTH ) , serum calcium , or urine calcium/creatinine were observed following either treatment . Following 16 weeks of treatment , significant improvements in FMD were only observed in the vitamin D group ( 1.8 ± 1.3 % ) , whereas the placebo group had no change ( -1.3 ± 0.6 % ) . Similarly , the vitamin D group exhibited an increase in absolute change in diameter ( 0.005 ± 0.004 cm ) and FMD/shear ( 0.08 ± 0.04 % /s(-1 ) , area under the curve ( AUC ) × 10(3 ) ) following treatment , whereas no change ( -0.005 ± 0.002 cm and -0.02 ± 0.02 % /s(-1 ) , AUC , respectively ) was observed following placebo . CONCLUSION Supplementation of 60,000 IU monthly oral vitamin D(3 ) ( ~2,000 IU/day ) for 16 weeks is effective at improving vascular endothelial function in African-American adults",
"BACKGROUND & AIMS Vitamin D supplementation has the potential to alleviate the cardiovascular damage in diabetic patients . The present study was design ed to evaluate long term impact of high doses of vitamin D on arterial properties , glucose homeostasis , adiponectin and leptin in patients with type 2 diabetes mellitus . METHODS AND RESULTS In r and omized , placebo-controlled study 47 diabetic patients were assigned into two groups : Group 1 received oral daily supplementation with vitamin D at a dose of 1000 U/day for 12 months . Group 2 received matching placebo capsules . Blood sampling for metabolic parameters , including fasting glucose , lipid profile , HbA1C , insulin , hs-CRP , 25 OH Vit D , adiponectin and leptin was performed at baseline and at the end of the study . Insulin resistance was assessed by homeostasis model assessment ( HOMA-IR ) . Central aortic augmentation index ( AI ) was evaluated using SphygmoCor . RESULTS The two groups were similar at baseline in terms of hemodynamic parameters . After 12 months , AI decreased significantly during the treatment period in patients received vitamin D ( p Glucose homeostasis parameters , leptin as well as leptin adiponectin ratio did not change in both groups . 25 OH Vit D level significantly increased ( p = 0.022 ) and circulating adiponectin marginally increased ( p = 0.065 ) during 12 month treatment period in active treatment and did not change in placebo group . CONCLUSIONS High doses of vitamin D supplementation in diabetic patients was associated with significant decrease in AI during one year treatment . This beneficial vascular effect was not associated with improvement in glucose homeostasis parameters",
"AIMS To test whether a single large dose of vitamin D2 can improve endothelial function in patients with Type 2 diabetes mellitus and low serum 25-hydroxyvitamin D levels . METHODS Double-blind , parallel group , placebo-controlled r and omized trial . A single dose of 100,000 IU vitamin D2 or placebo was administered to patients with Type 2 diabetes over the winter , when levels of circulating 25-hydroxyvitamin D were likely to be lowest . Patients were enrolled if their baseline 25-hydroxyvitamin D level was Endothelial function and blood pressure were measured and fasting blood sample s were taken at baseline and 8 weeks after administration of vitamin D. RESULTS Forty-nine per cent of subjects screened had 25-hydroxyvitamin D levels Vitamin D supplementation increased 25-hydroxyvitamin D levels by 15.3 nmol/l relative to placebo and significantly improved flow mediated vasodilatation ( FMD ) of the brachial artery by 2.3 % . The improvement in FMD remained significant after adjusting for changes in blood pressure . Vitamin D supplementation significantly decreased systolic blood pressure by 14 mmHg compared with placebo ; this did not correlate with change in FMD . CONCLUSIONS Vitamin D insufficiency is common in patients with Type 2 diabetes during winter in Scotl and . A single large dose of oral vitamin D2 improves endothelial function in patients with Type 2 diabetes and vitamin D insufficiency",
"OBJECTIVE Apart from its role in bone metabolism , vitamin D may also influence cardiovascular disease . The objective of this study was : ( 1 ) to determine the effect of a single , oral , high-dose vitamin D supplementation on endothelial function and arterial stiffness in patients with peripheral arterial disease ( PAD ) and ( 2 ) to investigate the impact of this supplementation on coagulation and inflammation parameters . METHODS In this double-blind , placebo-controlled , interventional pilot study , we screened 76 Caucasian patients with PAD for vitamin D deficiency . Sixty-two were r and omised to receive a single , oral supplementation of 100,000 IU vitamin D3 or placebo . At baseline and after 1 month , we measured serum vitamin D and parathormone levels , and surrogate parameters for cardiovascular disease . RESULTS Sixty-five of 76 patients ( 86 % ) had low 25-hydroxyvitamin D levels ( of those , 62 agreed to participate in the study . At baseline , only parathormone was related to vitamin D. In supplemented patients , vitamin D levels increased from 16.3 ± 6.7 to 24.3 ± 6.2 ng ml(-1 ) ( P vitamin levels did not change . Seasonal factors accounted for a decrease of vitamin D levels by 8 ng ml(-1 ) between summer and winter . After 1 month , none of the measured parameters was influenced by vitamin substitution . CONCLUSION In this pilot study , most patients with PAD were vitamin D deficient . Vitamin D supplementation increased serum 25-hydroxyvitamin D without influencing endothelial function , arterial stiffness , coagulation and inflammation parameters , although the study was underpowered for definite conclusions",
"Adequate vitamin D levels may promote cardiovascular health by improving endothelial function and down-regulating inflammation . The objective of this pilot trial was to investigate the effects of vitamin D repletion on endothelial function and inflammation in patients with coronary artery disease ( CAD ) . Using a double-blind placebo wait-list control design , 90 subjects with CAD and vitamin D deficiency ( were r and omized 1:1 to 50,000 IU of oral ergocalciferol or placebo weekly for 12 weeks . Endothelial function ( reactive hyperemia peripheral arterial tonometry , RH-PAT ) , circulating adhesion molecules , and pro-inflammatory cytokines were measured at baseline and 12 weeks . The median increase in serum 25-vitamin D from baseline was 26 ± 17 ng/ml in the active group and 4 ± 8 ng/ml in the placebo group ( between-group difference = 22 ng/ml , p median within-subject change in RH-PAT score was 0.13 ± 0.73 with active treatment and −0.04 ± 0.63 with placebo ( between-group difference = 0.17 , p = 0.44 ) . Within-group and between-group differences in intercellular adhesion molecule levels were greater with placebo ( between-group difference = 6 ng/ml , p = 0.048 ) . Vascular cell adhesion molecule levels decreased in both groups by a similar magnitude ( median difference between groups = 8.5 ng/ml , p = 0.79 ) . There was no difference between groups in magnitude of reduction in interleukin (IL)-12 ( −8.6 ng/ml , p = 0.72 ) and interferon-gamma ( 0.52 ng/ml , p = 0.88 ) . No significant differences in blood pressure , e-selectin , high-sensitivity c-reactive protein , IL-6 or the chemokine CXCL-10 were found with treatment . In conclusion , repleting vitamin D levels in subjects with CAD failed to demonstrate any benefits on surrogate markers of cardiovascular health . These results question the role of vitamin D supplementation in modifying cardiovascular disease"
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Historically , low-carbohydrate ( CHO ) and very-low-CHO diets have been used for weight loss . Recently , these diets have been promoted for type 2 diabetes ( T2D ) management . This scientific statement provides a comprehensive review of the current evidence base available from recent systematic review s and meta-analyses on the effects of low-CHO and very-low-CHO diets on body weight , lipoprotein lipids , glycemic control , and other cardiometabolic risk factors . In addition , evidence on emerging risk factors and potential safety concerns of low-CHO and very-low-CHO diets , especially for high-risk individuals , such as those with genetic lipid disorders , was review ed . Based on the evidence review ed , low-CHO and very-low-CHO diets are not superior to other dietary approaches for weight loss . These diets may have advantages related to appetite control , triglyceride reduction , and reduction in the use of medication in T2D management . The evidence review ed showed mixed effects on low-density lipoprotein cholesterol levels with some studies showing an increase . There was no clear evidence for advantages regarding effects on other cardiometabolic risk markers . Minimal data are available regarding long-term ( > 2 years ) efficacy and safety . Clinicians are encouraged to consider the evidence discussed in this scientific statement when counseling patients on the use of low-CHO and very-low-CHO diets
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"Background Our aim was to compare the effects of a Paleolithic ( ' Old Stone Age ' ) diet and a diabetes diet as generally recommended on risk factors for cardiovascular disease in patients with type 2 diabetes not treated with insulin . Methods In a r and omized cross-over study , 13 patients with type 2 diabetes , 3 women and 10 men , were instructed to eat a Paleolithic diet based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts ; and a Diabetes diet design ed in accordance with dietary guidelines during two consecutive 3-month periods . Outcome variables included changes in weight , waist circumference , serum lipids , C-reactive protein , blood pressure , glycated haemoglobin ( HbA1c ) , and areas under the curve for plasma glucose and plasma insulin in the 75 g oral glucose tolerance test . Dietary intake was evaluated by use of 4-day weighed food records . Results Study participants had on average a diabetes duration of 9 years , a mean HbA1c of 6,6 % units by Mono-S st and ard and were usually treated with metformin alone ( 3 subjects ) or metformin in combination with a sulfonylurea ( 3 subjects ) or a thiazolidinedione ( 3 subjects ) . Mean average dose of metformin was 1031 mg per day . Compared to the diabetes diet , the Paleolithic diet result ed in lower mean values of HbA1c ( -0.4 % units , p = 0.01 ) , triacylglycerol ( -0.4 mmol/L , p = 0.003 ) , diastolic blood pressure ( -4 mmHg , p = 0.03 ) , weight ( -3 kg , p = 0.01 ) , BMI ( -1 kg/m2 , p = 0.04 ) and waist circumference ( -4 cm , p = 0.02 ) , and higher mean values of high density lipoprotein cholesterol ( + 0.08 mmol/L , p = 0.03 ) . The Paleolithic diet was mainly lower in cereals and dairy products , and higher in fruits , vegetables , meat and eggs , as compared with the Diabetes diet . Further , the Paleolithic diet was lower in total energy , energy density , carbohydrate , dietary glycemic load , saturated fatty acids and calcium , and higher in unsaturated fatty acids , dietary cholesterol and several vitamins . Dietary GI was slightly lower in the Paleolithic diet ( GI = 50 ) than in the Diabetic diet ( GI = 55 ) . Conclusion Over a 3-month study period , a Paleolithic diet improved glycemic control and several cardiovascular risk factors compared to a Diabetes diet in patients with type 2 diabetes . Trial registration Clinical Trials.gov NCT00435240",
"OBJECTIVE To investigate the relative efficacy of four popular weight-loss programmes on plasma lipids and lipoproteins as measures of CVD risk . DESIGN A multi-centred , r and omised , controlled trial of four diets - Dr Atkins ' New Diet Revolution , The Slim-Fast Plan , Weight Watchers Pure Points programme and Rosemary Conley 's ' Eat yourself Slim ' Diet and Fitness Plan - against a control diet , in parallel for 6 months . SETTING AND SUBJECTS The trial was conducted at five universities across the UK ( Surrey , Nottingham , Ulster ( Coleraine ) , Bristol and Edinburgh ( Queen Margaret University College ) ) and involved the participation of 300 overweight and obese males and females aged 21 - 60 years in a community setting . RESULTS Significant weight loss was achieved by all dieting groups ( 5 - 9 kg at 6 months ) but no significant difference was observed between diets at 6 months . The Weight Watchers and Rosemary Conley ( low-fat ) diets were followed by significant reductions in plasma LDL cholesterol ( both -12.2 % after 6 months , P Atkins ( low-carbohydrate ) and Weight Watchers diets were followed by marked reductions in plasma TAG ( -38.2 % and -22.6 % at 6 months respectively , P LDL particle size , a change that has been linked to reduced CVD risk . CONCLUSIONS Overall , these results demonstrate the favourable effects of weight loss on lipid-mediated CVD risk factors that can be achieved through commercially available weight-loss programmes . No detrimental effects on lipid-based CVD risk factors were observed in participants consuming a low-carbohydrate diet ",
"Context : Common concerns when using low-calorie diets as a treatment for obesity are the reduction in fat-free mass , mostly muscular mass , that occurs together with the fat mass ( FM ) loss , and determining the best method ologies to evaluate body composition changes . Objective : This study aim ed to evaluate the very-low-calorie ketogenic ( VLCK ) diet-induced changes in body composition of obese patients and to compare 3 different method ologies used to evaluate those changes . Design : Twenty obese patients followed a VLCK diet for 4 months . Body composition assessment was performed by dual-energy X-ray absorptiometry ( DXA ) , multifrequency bioelectrical impedance ( MF-BIA ) , and air displacement plethysmography ( ADP ) techniques . Muscular strength was also assessed . Measurements were performed at 4 points matched with the ketotic phases ( basal , maximum ketosis , ketosis declining , and out of ketosis ) . Results : After 4 months the VLCK diet induced a −20.2 ± 4.5 kg weight loss , at expenses of reductions in fat mass ( FM ) of −16.5 ± 5.1 kg ( DXA ) , −18.2 ± 5.8 kg ( MF-BIA ) , and −17.7 ± 9.9 kg ( ADP ) . A substantial decrease was also observed in the visceral FM . The mild but marked reduction in fat-free mass occurred at maximum ketosis , primarily as a result of changes in total body water , and was recovered thereafter . No changes in muscle strength were observed . A strong correlation was evidence d between the 3 methods of assessing body composition . Conclusion : The VLCK diet-induced weight loss was mainly at the expense of FM and visceral mass ; muscle mass and strength were preserved . Of the 3 body composition techniques used , the MF-BIA method seems more convenient in the clinical setting",
"OBJECTIVE Development of these guidelines is m and ated by the American Association of Clinical Endocrinologists ( AACE ) Board of Directors and the American College of Endocrinology ( ACE ) Board of Trustees and adheres to published AACE protocol s for the st and ardized production of clinical practice guidelines ( CPGs ) . METHODS Recommendations are based on diligent review of clinical evidence with transparent incorporation of subjective factors . RESULTS There are 9 broad clinical questions with 123 recommendation numbers that include 160 specific statements ( 85 [ 53.1 % ] strong [ Grade A ] ; 48 [ 30.0 % ] intermediate [ Grade B ] , and 11 [ 6.9 % ] weak [ Grade C ] , with 16 [ 10.0 % ] based on expert opinion [ Grade D ] ) that build a comprehensive medical care plan for obesity . There were 133 ( 83.1 % ) statements based on strong ( best evidence level [ BEL ] 1 = 79 [ 49.4 % ] ) or intermediate ( BEL 2 = 54 [ 33.7 % ] ) levels of scientific substantiation . There were 34 ( 23.6 % ) evidence -based recommendation grade s ( Grade s A-C = 144 ) that were adjusted based on subjective factors . Among the 1,790 reference citations used in this CPG , 524 ( 29.3 % ) were based on strong ( evidence level [ EL ] 1 ) , 605 ( 33.8 % ) were based on intermediate ( EL 2 ) , and 308 ( 17.2 % ) were based on weak ( EL 3 ) scientific studies , with 353 ( 19.7 % ) based on review s and opinions ( EL 4 ) . CONCLUSION The final recommendations recognize that obesity is a complex , adiposity-based chronic disease , where management targets both weight-related complications and adiposity to improve overall health and quality of life . The detailed evidence -based recommendations allow for nuanced clinical decision-making that addresses real-world medical care of patients with obesity , including screening , diagnosis , evaluation , selection of therapy , treatment goals , and individualization of care . The goal is to facilitate high- quality care of patients with obesity and provide a rational , scientific approach to management that optimizes health outcomes and safety . ABBREVIATIONS A1C = hemoglobin A1c AACE = American Association of Clinical Endocrinologists ACE = American College of Endocrinology ACSM = American College of Sports Medicine ADA = American Diabetes Association ADAPT = Arthritis , Diet , and Activity Promotion Trial ADHD = attention-deficit hyperactivity disorder AHA = American Heart Association AHEAD = Action for Health in Diabetes AHI = apnea-hypopnea index ALT = alanine aminotransferase AMA = American Medical Association ARB = angiotensin receptor blocker ART = assisted reproductive technology AUC = area under the curve BDI = Beck Depression Inventory BED = binge eating disorder BEL = best evidence level BLOOM = Behavioral Modification and Lorcaserin for Overweight and Obesity Management BLOSSOM = Behavioral Modification and Lorcaserin Second Study for Obesity Management BMI = body mass index BP = blood pressure C-SSRS = Columbia Suicidality Severity Rating Scale CAD = coronary artery disease CARDIA = Coronary Artery Risk Development in Young Adults CBT = cognitive behavioral therapy CCO = Consensus Conference on Obesity CHF = congestive heart failure CHO = carbohydrate CI = confidence interval COR-I = Contrave Obesity Research I CPG = clinical practice guideline CV = cardiovascular CVD = cardiovascular disease DASH = Dietary Approaches to Stop Hypertension DBP = diastolic blood pressure DEXA = dual-energy X-ray absorptiometry DPP = Diabetes Prevention Program DSE = diabetes support and education EL = evidence level ED = erectile dysfunction ER = extended release EWL = excess weight loss FDA = Food and Drug Administration FDG = 18F-fluorodeoxyglucose GABA = gamma-aminobutyric acid GERD = gastroesophageal reflux disease GI = gastrointestinal GLP-1 = glucagon-like peptide 1 HADS = Hospital Anxiety and Depression Scale HDL-c = high-density lipoprotein cholesterol HR = hazard ratio HTN = hypertension HUNT = Nord-Trøndelag Health Study ICSI = intracytoplasmic sperm injection IFG = impaired fasting glucose IGT = impaired glucose tolerance ILI = intensive lifestyle intervention IVF = in vitro fertilization LAGB = laparoscopic adjustable gastric b and ing LDL-c = low-density lipoprotein cholesterol LES = lower esophageal sphincter LSG = laparoscopic sleeve gastrectomy LV = left ventricle LVH = left ventricular hypertrophy LVBG = laparoscopic vertical b and ed gastroplasty MACE = major adverse cardiovascular events MAOI = monoamine oxidase inhibitor MI = myocardial infa rct ion MN RCT = meta- analysis of non-r and omized prospect i ve or case-controlled trials MRI = magnetic resonance imaging MUFA = monounsaturated fatty acid NAFLD = nonalcoholic fatty liver disease NASH = nonalcoholic steatohepatitis NES = night eating syndrome NHANES = National Health and Nutrition Examination Surveys NHLBI = National Heart , Lung , and Blood Institute NHS = Nurses ' Health Study NICE = National Institute for Health and Care Excellence OA = osteoarthritis OGTT = oral glucose tolerance test OR = odds ratio OSA = obstructive sleep apnea PHQ-9 = Patient Health Question naire PCOS = polycystic ovary syndrome PCP = primary care physician POMC = pro-opiomelanocortin POWER = Practice -Based Opportunities for Weight Reduction PPI = proton pump inhibitor PRIDE = Program to Reduce Incontinence by Diet and Exercise PSA = prostate specific antigen QOL = quality of life RA = receptor agonist RCT = r and omized controlled trial ROC = receiver operator characteristic RR = relative risk RYGB = Roux-en-Y gastric bypass SAD = sagittal abdominal diameter SBP = systolic blood pressure SCOUT = Sibutramine Cardiovascular Outcome Trial SG = sleeve gastrectomy SHBG = sex hormonebinding globulin SIEDY = Structured Interview on Erectile Dysfunction SNRI = serotonin-norepinephrine reuptake inhibitors SOS = Swedish Obese Subjects SS = surveillance study SSRI = selective serotonin reuptake inhibitors STORM = Sibutramine Trial on Obesity Reduction and Maintenance TCA = tricyclic antidepressant TONE = Trial of Nonpharmacologic Intervention in the Elderly TOS = The Obesity Society T2DM = type 2 diabetes mellitus UKPDS = United Kingdom Prospect i ve Diabetes Study U.S = United States VAT = visceral adipose tissue VLDL = very low-density lipoprotein WC = waist circumference WHO = World Health Organization WHR = waist-hip ratio WHtR = waist-to-height ratio WMD = weighted mean difference WOMAC = Western Ontario and McMaster Universities osteoarthritis index XENDOS = XEnical in the Prevention of Diabetes in Obese Subjects ",
"BACKGROUND Altering the macronutrient composition of the diet influences hunger and satiety . Studies have compared high- and low-protein diets , but there are few data on carbohydrate content and ketosis on motivation to eat and ad libitum intake . OBJECTIVE We aim ed to compare the hunger , appetite , and weight-loss responses to a high-protein , low-carbohydrate [ ( LC ) ketogenic ] and those to a high-protein , medium-carbohydrate [ ( MC ) nonketogenic ] diet in obese men feeding ad libitum . DESIGN Seventeen obese men were studied in a residential trial ; food was provided daily . Subjects were offered 2 high-protein ( 30 % of energy ) ad libitum diets , each for a 4-wk period-an LC ( 4 % carbohydrate ) ketogenic diet and an MC ( 35 % carbohydrate ) diet-r and omized in a crossover design . Body weight was measured daily , and ketosis was monitored by analysis of plasma and urine sample s. Hunger was assessed by using a computerized visual analogue system . RESULTS Ad libitum energy intakes were lower with the LC diet than with the MC diet [ P=0.02 ; SE of the difference ( SED ) : 0.27 ] at 7.25 and 7.95 MJ/d , respectively . Over the 4-wk period , hunger was significantly lower ( P=0.014 ; SED : 1.76 ) and weight loss was significantly greater ( P=0.006 ; SED : 0.62 ) with the LC diet ( 6.34 kg ) than with the MC diet ( 4.35 kg ) . The LC diet induced ketosis with mean 3-hydroxybutyrate concentrations of 1.52 mmol/L in plasma ( P=0.036 from baseline ; SED : 0.62 ) and 2.99 mmol/L in urine ( P hunger and lower food intake significantly more than do high-protein , medium-carbohydrate nonketogenic diets",
"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",
"BACKGROUND The optimal source and amount of dietary carbohydrate for managing type 2 diabetes ( T2DM ) are unknown . OBJECTIVE We aim ed to compare the effects of altering the glycemic index or the amount of carbohydrate on glycated hemoglobin ( HbA1c ) , plasma glucose , lipids , and C-reactive protein ( CRP ) in T2DM patients . DESIGN Subjects with T2DM managed by diet alone ( n=162 ) were r and omly assigned to receive high-carbohydrate , high-glycemic-index ( high-GI ) , high-carbohydrate , low-glycemic-index ( low-GI ) , or low-carbohydrate , high-monounsaturated-fat ( low-CHO ) diets for 1 y. RESULTS The high-GI , low-GI , and low-CHO diets contained , respectively , 47 % , 52 % , and 39 % of energy as carbohydrate and 31 % , 27 % , and 40 % of energy as fat ; they had GIs of 63 , 55 , and 59 , respectively . Body weight and HbA1c did not differ significantly between diets . Fasting glucose was higher ( P=0.041 ) , but 2-h postload glucose was lower ( P=0.010 ) after 12 mo of the low-GI diet . With the low-GI diet , overall mean triacylglycerol was 12 % higher and HDL cholesterol 4 % lower than with the low-CHO diet ( P ratio of total to HDL cholesterol disappeared by 6 mo ( time x diet interaction , P=0.044 ) . Overall mean CRP with the low-GI diet , 1.95 mg/L , was 30 % less than that with the high-GI diet , 2.75 mg/L ( P=0.0078 ) ; the concentration with the low-CHO diet , 2.35 mg/L , was intermediate . CONCLUSIONS In subjects with T2DM managed by diet alone with optimal glycemic control , long-term HbA1c was not affected by altering the GI or the amount of dietary carbohydrate . Differences in total : HDL cholesterol among diets had disappeared by 6 mo . However , because of sustained reductions in postpr and ial glucose and CRP , a low-GI diet may be preferred for the dietary management of T2DM",
"BACKGROUND The possible advantage for weight loss of a diet that emphasizes protein , fat , or carbohydrates has not been established , and there are few studies that extend beyond 1 year . METHODS We r and omly assigned 811 overweight adults to one of four diets ; the targeted percentages of energy derived from fat , protein , and carbohydrates in the four diets were 20 , 15 , and 65 % ; 20 , 25 , and 55 % ; 40 , 15 , and 45 % ; and 40 , 25 , and 35 % . The diets consisted of similar foods and met guidelines for cardiovascular health . The participants were offered group and individual instructional sessions for 2 years . The primary outcome was the change in body weight after 2 years in two-by-two factorial comparisons of low fat versus high fat and average protein versus high protein and in the comparison of highest and lowest carbohydrate content . RESULTS At 6 months , participants assigned to each diet had lost an average of 6 kg , which represented 7 % of their initial weight ; they began to regain weight after 12 months . By 2 years , weight loss remained similar in those who were assigned to a diet with 15 % protein and those assigned to a diet with 25 % protein ( 3.0 and 3.6 kg , respectively ) ; in those assigned to a diet with 20 % fat and those assigned to a diet with 40 % fat ( 3.3 kg for both groups ) ; and in those assigned to a diet with 65 % carbohydrates and those assigned to a diet with 35 % carbohydrates ( 2.9 and 3.4 kg , respectively ) ( P>0.20 for all comparisons ) . Among the 80 % of participants who completed the trial , the average weight loss was 4 kg ; 14 to 15 % of the participants had a reduction of at least 10 % of their initial body weight . Satiety , hunger , satisfaction with the diet , and attendance at group sessions were similar for all diets ; attendance was strongly associated with weight loss ( 0.2 kg per session attended ) . The diets improved lipid-related risk factors and fasting insulin levels . CONCLUSIONS Reduced-calorie diets result in clinical ly meaningful weight loss regardless of which macronutrients they emphasize . ( Clinical Trials.gov number , NCT00072995 .",
"BACKGROUND Few well-controlled studies have comprehensively examined the effects of very-low-carbohydrate diets on type 2 diabetes ( T2D ) . OBJECTIVE We compared the effects of a very-low-carbohydrate , high-unsaturated fat , low-saturated fat ( LC ) diet with a high-carbohydrate , low-fat ( HC ) diet on glycemic control and cardiovascular disease risk factors in T2D after 52 wk . DESIGN In this r and omized controlled trial that was conducted in an outpatient research clinic , 115 obese adults with T2D [ mean ± SD age : 58 ± 7 y ; body mass index ( in kg/m(2 ) ) : 34.6 ± 4.3 ; glycated hemoglobin ( HbA1c ) : 7.3 ± 1.1 % ; duration of diabetes : 8 ± 6 y ] were r and omly assigned to consume either a hypocaloric LC diet [ 14 % of energy as carbohydrate ( carbohydrate ] or an energy-matched HC diet [ 53 % of energy as carbohydrate , 17 % of energy as protein , and 30 % of energy as fat ( 10 % saturated fat ) ] combined with supervised aerobic and resistance exercise ( 60 min ; 3 d/wk ) . Outcomes were glycemic control assessed with use of measurements of HbA1c , fasting blood glucose , glycemic variability assessed with use of 48-h continuous glucose monitoring , diabetes medication , weight , blood pressure , and lipids assessed at baseline , 24 , and 52 wk . RESULTS Both groups achieved similar completion rates ( LC diet : 71 % ; HC diet : 65 % ) and mean ( 95 % CI ) reductions in weight [ LC diet : -9.8 kg ( -11.7 , -7.9 kg ) ; HC diet : -10.1 kg ( -12.0 , -8.2 kg ) ] , blood pressure [ LC diet : -7.1 ( -10.6 , -3.7)/-6.2 ( -8.2 , -4.1 ) mm Hg ; HC diet : -5.8 ( -9.4 , -2.2)/-6.4 ( -8.4 , -4.3 ) mm Hg ] , HbA1c [ LC diet : -1.0 % ( -1.2 % , -0.7 % ) ; HC diet : -1.0 % ( -1.3 % , -0.8 % ) ] , fasting glucose [ LC diet : -0.7 mmol/L ( -1.3 , -0.1 mmol/L ) ; HC diet : -1.5 mmol/L ( -2.1 , -0.8 mmol/L ) ] , and LDL cholesterol [ LC diet : -0.1 mmol/L ( -0.3 , 0.1 mmol/L ) ; HC diet : -0.2 mmol/L ( -0.4 , 0.03 mmol/L ) ] ( P-diet effect ≥ 0.10 ) . Compared with the HC-diet group , the LC-diet group achieved greater mean ( 95 % CI ) reductions in the diabetes medication score [ LC diet : -0.5 arbitrary units ( -0.7 , -0.4 arbitrary units ) ; HC diet : -0.2 arbitrary units ( -0.4 , -0.06 arbitrary units ) ; P = 0.02 ] , glycemic variability assessed by measuring the continuous overall net glycemic action-1 [ LC diet : -0.5 mmol/L ( -0.6 , -0.3 mmol/L ) ; HC diet : -0.05 mmol/L ( -0.2 , -0.1 mmol/L ) ; P = 0.003 ] , and triglycerides [ LC diet : -0.4 mmol/L ( -0.5 , -0.2 mmol/L ) ; HC diet : -0.01 mmol/L ( -0.2 , 0.2 mmol/L ) ; P = 0.001 ] and greater mean ( 95 % CI ) increases in HDL cholesterol [ LC diet : 0.1 mmol/L ( 0.1 , 0.2 mmol/L ) ; HC diet : 0.06 mmol/L ( -0.01 , 0.1 mmol/L ) ; P = 0.002 ] . CONCLUSIONS Both diets achieved substantial weight loss and reduced HbA1c and fasting glucose . The LC diet , which was high in unsaturated fat and low in saturated fat , achieved greater improvements in the lipid profile , blood glucose stability , and reductions in diabetes medication requirements , suggesting an effective strategy for the optimization of T2D management . This trial was registered at www.anzctr.org.au as ACTRN12612000369820",
"BACKGROUND Long-term weight loss and cardiometabolic effects of a very-low-carbohydrate , high-saturated-fat diet ( LC ) and a high-carbohydrate , low-fat diet ( LF ) have not been evaluated under isocaloric conditions . OBJECTIVE The objective was to compare an energy-controlled LC diet with an LF diet at 1 y. DESIGN Men and women ( n = 118 ) with abdominal obesity and at least one additional metabolic syndrome risk factor were r and omly assigned to either an energy-restricted ( approximately 6 - 7 MJ ) LC diet ( 4 % , 35 % , and 61 % of energy as carbohydrate , protein , and fat , respectively ) or an isocaloric LF diet ( 46 % , 24 % , and 30 % of energy as carbohydrate , protein , and fat , respectively ) for 1 y. Weight , body composition , and cardiometabolic risk markers were assessed . RESULTS Sixty-nine participants ( 59 % ) completed the trial : 33 in the LC group and 36 in the LF group . Both groups lost similar amounts of weight ( LC : -14.5 + /- 1.7 kg ; LF : -11.5 + /- 1.2 kg ; P = 0.14 , time x diet ) and body fat ( LC : -11.3 + /- 1.5 kg ; LF : -9.4 + /- 1.2 kg ; P = 0.30 ) . Blood pressure , fasting glucose , insulin , insulin resistance , and C-reactive protein decreased independently of diet composition . Compared with the LF group , the LC group had greater decreases in triglycerides ( -0.36 + /- 0.15 mmol/L ; 95 % CI : -0.67 , -0.05 mmol/L ; P = 0.011 ) , increases in HDL cholesterol ( 0.23 + /- 0.09 mmol/L ; 95 % CI : 0.06 , 0.40 mmol/L ; P = 0.018 ) and LDL cholesterol ( 0.6 + /- 0.2 mmol/L ; 95 % CI : 0.2 , 1.0 mmol/L ; P = 0.001 ) , and a greater but nonsignificant increase in apolipoprotein B ( 0.08 + /- 0.04 g/L ; 95 % CI : -0.004 , 0.171 g/L ; P = 0.17 ) . CONCLUSIONS Under planned isoenergetic conditions , as expected , both dietary patterns result ed in similar weight loss and changes in body composition . The LC diet may offer clinical benefits to obese persons with insulin resistance . However , the increase in LDL cholesterol with the LC diet suggests that this measure should be monitored . This trial was registered with the Australian New Zeal and Clinical Trials Registry at ( http://www.anzctr.org.au ) as ACTR 12606000203550",
"Very low-carbohydrate diets are often used to promote weight loss , but their effects on bowel health and function are largely unknown . We compared the effects of a very low-carbohydrate , high-fat ( LC ) diet with a high-carbohydrate , high-fibre , low-fat ( HC ) diet on indices of bowel health and function . In a parallel study design , ninety-one overweight and obese participants ( age 50.6 ( sd 7.5 ) years ; BMI 33.7 ( sd 4.2 ) kg/m(2 ) ) were r and omly assigned to either an energy-restricted ( about 6 - 7 MJ , 30 % deficit ) planned isoenergetic LC or HC diet for 8 weeks . At baseline and week 8 , 24 h urine and faecal collection s were obtained and a bowel function question naire was completed . Compared with the HC group , there were significant reductions in the LC group for faecal output ( 21 ( sd 145 ) v. - 61 ( sd 147 ) g ) , defecation frequency , faecal excretion and concentrations of butyrate ( - 0.5 ( sd 10.4 ) v. - 3.9 ( sd 9.7 ) mmol/l ) and total SCFA ( 1.4 ( sd 40.5 ) v. - 15.8 ( sd 43.6 ) mmol/l ) and counts of bifidobacteria ( P Urinary phenols and p-cresol excretion decreased ( P or = 0.25 ) . Faecal form , pH , ammonia concentration and numbers of coliforms and Escherichia coli did not change with either diet . No differences between the diets were evident for incidences of adverse gastrointestinal symptoms , which suggests that both diets were well tolerated . Under energy-restricted conditions , a short-term LC diet lowered stool weight and had detrimental effects on the concentration and excretion of faecal SCFA compared with an HC diet . This suggests that the long-term consumption of an LC diet may increase the risk of development of gastrointestinal disorders",
"BACKGROUND Both genetic and lifestyle factors contribute to individual-level risk of coronary artery disease . The extent to which increased genetic risk can be offset by a healthy lifestyle is unknown . METHODS Using a polygenic score of DNA sequence polymorphisms , we quantified genetic risk for coronary artery disease in three prospect i ve cohorts - 7814 participants in the Atherosclerosis Risk in Communities ( ARIC ) study , 21,222 in the Women 's Genome Health Study ( WGHS ) , and 22,389 in the Malmö Diet and Cancer Study ( MDCS ) - and in 4260 participants in the cross-sectional BioImage Study for whom genotype and covariate data were available . We also determined adherence to a healthy lifestyle among the participants using a scoring system consisting of four factors : no current smoking , no obesity , regular physical activity , and a healthy diet . RESULTS The relative risk of incident coronary events was 91 % higher among participants at high genetic risk ( top quintile of polygenic scores ) than among those at low genetic risk ( bottom quintile of polygenic scores ) ( hazard ratio , 1.91 ; 95 % confidence interval [ CI ] , 1.75 to 2.09 ) . A favorable lifestyle ( defined as at least three of the four healthy lifestyle factors ) was associated with a substantially lower risk of coronary events than an unfavorable lifestyle ( defined as no or only one healthy lifestyle factor ) , regardless of the genetic risk category . Among participants at high genetic risk , a favorable lifestyle was associated with a 46 % lower relative risk of coronary events than an unfavorable lifestyle ( hazard ratio , 0.54 ; 95 % CI , 0.47 to 0.63 ) . This finding corresponded to a reduction in the st and ardized 10-year incidence of coronary events from 10.7 % for an unfavorable lifestyle to 5.1 % for a favorable lifestyle in ARIC , from 4.6 % to 2.0 % in WGHS , and from 8.2 % to 5.3 % in MDCS . In the BioImage Study , a favorable lifestyle was associated with significantly less coronary-artery calcification within each genetic risk category . CONCLUSIONS Across four studies involving 55,685 participants , genetic and lifestyle factors were independently associated with susceptibility to coronary artery disease . Among participants at high genetic risk , a favorable lifestyle was associated with a nearly 50 % lower relative risk of coronary artery disease than was an unfavorable lifestyle . ( Funded by the National Institutes of Health and others . )",
"BACKGROUND & AIMS This 6-month prospect i ve , single-arm observational study was design ed to assess the effects of the KD on the nutritional status , resting energy expenditure ( REE ) , and substrate oxidation in patients with drug-resistant epilepsy . METHODS Eighteen patients with medically refractory epilepsy underwent assessment of body composition , REE , and substrate oxidation rates before and after 6 months of KD . RESULTS Compared with baseline , there were no statistically significant differences at 6 months in terms of height , weight , BMI z-scores , and REE . However , the respiratory quotient decreased significantly ( from 0.80 ± 0.06 to 0.72 ± 0.05 , p whereas fat oxidation was significantly increased ( from 50.9 ± 25.2 mg/min to 97.5 ± 25.7 mg/min , p increase in fat oxidation was the main independent predictor of the reduction in seizure frequency ( beta = -0.97 , t = -6.3 , p a KD for 6 months in patients with medically refractory epilepsy increases fat oxidation and decreases the respiratory quotient , without appreciable changes in REE",
"BACKGROUND AND AIMS The relationship between dietary macronutrient composition and appetite is controversial . We examined the effects of a year-long low-carbohydrate diet compared to a low-fat diet on appetite-related hormones and self-reported change in appetite . METHODS AND RESULTS A total of 148 adults with a body mass index 30 - 45 kg/m(2 ) , who were free of diabetes , cardiovascular disease and chronic kidney disease at baseline were r and omly assigned to either a low-carbohydrate diet ( carbohydrate [ excluding dietary fiber] g/day ; N = 75 ) or a low-fat diet ( , saturated fat ; N = 73 ) . Participants in both groups attended individual and group dietary counseling sessions where they were provided the same behavioral curriculum and advised to maintain baseline levels of physical activity . Appetite and appetite-related hormones were measured at 0 , 3 , 6 and 12 months of intervention . At 12 months , mean changes ( 95 % CI ) in peptide YY were -34.8 pg/mL ( -41.0 to -28.6 ) and in the low-carbohydrate group and -44.2 pg/mL ( -50.4 to -38.0 ) in the low-fat group ( net change : 9.54 pg/mL [ 0.6 to 18.2 ] ; p = 0.036 ) . Approximately 99 % of dietary effects on peptide YY are explained by differences in dietary macronutrient content . There was no difference in change in ghrelin or self-reported change in appetite between the groups . CONCLUSIONS A low-fat diet reduced peptide YY more than a low-carbohydrate diet . These findings suggest that satiety may be better preserved on a low-carbohydrate diet , as compared to a low fat diet . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00609271",
"BACKGROUND Very low-carbohydrate ( LC ) diets are often used to promote weight loss , but the long-term effects on psychological function remain unknown . METHODS A total of 106 overweight and obese participants ( mean [ SE ] age , 50.0 [ 0.8 ] years ; mean [ SE ] body mass index [ calculated as weight in kilograms divided by height in meters squared ] , 33.7 [ 0.4 ] ) were r and omly assigned either to an energy-restricted ( approximately 1433 - 1672 kcal [ to convert to kilojoules , multiply by 4.186 ] ) , planned isocaloric , very low-carbohydrate , high-fat ( LC ) diet or to a high-carbohydrate , low-fat ( LF ) diet for 1 year . Changes in body weight , psychological mood and well-being ( Profile of Mood States , Beck Depression Inventory , and Spielberger State Anxiety Inventory scores ) , and cognitive functioning ( working memory and speed of processing ) were assessed . RESULTS By 1 year , the overall mean ( SE ) weight loss was 13.7 ( 1.8 ) kg , with no significant difference between groups ( P = .26 ) . Over the course of the study , there were significant time x diet interactions for Spielberger State Anxiety Inventory , Beck Depression Inventory , and Profile of Mood States scores for total mood disturbance , anger-hostility , confusion-bewilderment , and depression-dejection ( P Working memory improved by 1 year ( P speed of processing remained largely unchanged , with no effect of diet composition on either cognitive domain . CONCLUSIONS Over 1 year , there was a favorable effect of an energy-restricted LF diet compared with an isocaloric LC diet on mood state and affect in overweight and obese individuals . Both diets had similar effects on working memory and speed of processing . Trial Registration anzctr.org.au Identifier : 12606000203550",
"Abstract . This study was conducted to assess whether the natriuresis occurring early in a fast , and the renal sodium retention setting in upon carbohydrate or protein refeeding , can be entirely accounted for on the basis of concomitant changes in renal ketone body and ammonia excretion . To this end , the renal excretion of sodium , 3‐hydroxybutyrate ( 3‐OHB ) and ammonium was determined in non‐diabetic obese subjects su bmi tted to total fast according to the following protocol s : ( 1 ) 6 day fast : considered as control group ( n= 11 ) ; ( 2 ) 8 day fast save for an isolated 100 g oral glucose load on day 4 ( n= 12 ) ; ( 3 ) 8 day fast with , on day 4 , the same glucose load followed by a 6 h infusion of glucagon , 1 mg in 500 ml 5 % glucose ( n= 7 ) ; ( 4 ) 5 day total fast followed by 3 days of protein refeeding ( 53 g protein daily ; n = 8) . All subjects were refed with a mixed 4.2 MJ diet at the end of the studies",
"BACKGROUND The carbohydrate-insulin model of obesity posits that habitual consumption of a high-carbohydrate diet sequesters fat within adipose tissue because of hyperinsulinemia and results in adaptive suppression of energy expenditure ( EE ) . Therefore , isocaloric exchange of dietary carbohydrate for fat is predicted to result in increased EE , increased fat oxidation , and loss of body fat . In contrast , a more conventional view that \" a calorie is a calorie \" predicts that isocaloric variations in dietary carbohydrate and fat will have no physiologically important effects on EE or body fat . OBJECTIVE We investigated whether an isocaloric low-carbohydrate ketogenic diet ( KD ) is associated with changes in EE , respiratory quotient ( RQ ) , and body composition . DESIGN Seventeen overweight or obese men were admitted to metabolic wards , where they consumed a high-carbohydrate baseline diet ( BD ) for 4 wk followed by 4 wk of an isocaloric KD with clamped protein . Subjects spent 2 consecutive days each week residing in metabolic chambers to measure changes in EE ( EEchamber ) , sleeping EE ( SEE ) , and RQ . Body composition changes were measured by dual-energy X-ray absorptiometry . Average EE during the final 2 wk of the BD and KD periods was measured by doubly labeled water ( EEDLW ) . RESULTS Subjects lost weight and body fat throughout the study corresponding to an overall negative energy balance of ∼300 kcal/d . Compared with BD , the KD coincided with increased EEchamber ( 57 ± 13 kcal/d , P = 0.0004 ) and SEE ( 89 ± 14 kcal/d , P and decreased RQ ( -0.111 ± 0.003 , P increased by 151 ± 63 kcal/d ( P = 0.03 ) . Body fat loss slowed during the KD and coincided with increased protein utilization and loss of fat-free mass . CONCLUSION The isocaloric KD was not accompanied by increased body fat loss but was associated with relatively small increases in EE that were near the limits of detection with the use of state-of-the-art technology . This trial was registered at clinical trials.gov as NCT01967563",
"BACKGROUND AND AIMS The effects of a low carbohydrate/high fat ( LCHF ) diet on health are debated . This study aims to explore the effects of a diet with less than 20 g carbohydrates per day ( LCHF ) on plasma low density lipoprotein cholesterol ( LDL-C ) in young and healthy adults . The secondary aim is the assessment of lipid profile and peripheral blood mononuclear cells ( P BMC ) gene expression . METHODS This was a r and omized controlled parallel- design ed intervention study . Participants were either assigned to a three-week LCHF diet or a control group continuing habitual diet ad libitum , in both groups . RESULTS In total , 30 healthy normal weight participants completed the study . Nine subjects did not complete it due to adverse events or withdrawn consent . In the LCHF diet group ( n = 15 ) , plasma LDL-C increased from ( mean ± SD ) 2.2 ± 0.4 mmol/l before intervention to 3.1 ± 0.8 after , while in the control group ( n = 15 ) , LDL-C remained unchanged : 2.5 ± 0.8 mmol/l ( p in apolipoprotein B , total cholesterol , high-density lipoprotein cholesterol , free fatty acids , uric acid and urea in the LCHF group versus controls . Plasma levels of triglycerides , lipoprotein ( a ) , glucose , C-peptide or C-reactive protein ( CRP ) , blood pressure , body weight or body composition did not differ between the groups . P BMC gene expression of sterol regulator element binding protein 1 ( SREBP-1 ) was increased in the LCHF group versus controls ( p ≤ 0.01 ) . The individual increase in LDL-C from baseline varied between 5 and 107 % in the LCHF group . CONCLUSIONS An LCHF diet for three weeks increased LDL-C with 44 % versus controls . The individual response on LCHF varied profoundly",
"Abstract Objective To determine the effects of diets varying in carbohydrate to fat ratio on total energy expenditure . Design R and omized trial . Setting Multicenter collaboration at US two sites , August 2014 to May 2017 . Participants 164 adults aged 18 - 65 years with a body mass index of 25 or more . Interventions After 12 % ( within 2 % ) weight loss on a run-in diet , participants were r and omly assigned to one of three test diets according to carbohydrate content ( high , 60 % , n=54 ; moderate , 40 % , n=53 ; or low , 20 % , n=57 ) for 20 weeks . Test diets were controlled for protein and were energy adjusted to maintain weight loss within 2 kg . To test for effect modification predicted by the carbohydrate-insulin model , the sample was divided into thirds of pre-weight loss insulin secretion ( insulin concentration 30 minutes after oral glucose ) . Main outcome measures The primary outcome was total energy expenditure , measured with doubly labeled water , by intention-to-treat analysis . Per protocol analysis included participants who maintained target weight loss , potentially providing a more precise effect estimate . Secondary outcomes were resting energy expenditure , measures of physical activity , and levels of the metabolic hormones leptin and ghrelin . Results Total energy expenditure differed by diet in the intention-to-treat analysis ( n=162 , P=0.002 ) , with a linear trend of 52 kcal/d ( 95 % confidence interval 23 to 82 ) for every 10 % decrease in the contribution of carbohydrate to total energy intake ( 1 kcal=4.18 kJ=0.00418 MJ ) . Change in total energy expenditure was 91 kcal/d ( 95 % confidence interval −29 to 210 ) greater in participants assigned to the moderate carbohydrate diet and 209 kcal/d ( 91 to 326 ) greater in those assigned to the low carbohydrate diet compared with the high carbohydrate diet . In the per protocol analysis ( n=120 , P pre-weight loss insulin secretion , the difference between the low and high carbohydrate diet was 308 kcal/d in the intention-to-treat analysis and 478 kcal/d in the per protocol analysis ( P was significantly lower in participants assigned to the low carbohydrate diet compared with those assigned to the high carbohydrate diet ( both analyses ) . Leptin was also significantly lower in participants assigned to the low carbohydrate diet ( per protocol ) . Conclusions Consistent with the carbohydrate-insulin model , lowering dietary carbohydrate increased energy expenditure during weight loss maintenance . This metabolic effect may improve the success of obesity treatment , especially among those with high insulin secretion . Trial registration Clinical Trials.gov NCT02068885",
"OBJECTIVE To comprehensively compare the effects of a very low-carbohydrate , high – unsaturated/low – saturated fat diet ( LC ) with those of a high – unrefined carbohydrate , low-fat diet ( HC ) on glycemic control and cardiovascular disease ( CVD ) risk factors in type 2 diabetes ( T2DM ) . RESEARCH DESIGN AND METHODS Obese adults ( n = 115 , BMI 34.4 ± 4.2 kg/m2 , age 58 ± 7 years ) with T2DM were r and omized to a hypocaloric LC diet ( 14 % carbohydrate [ or an energy-matched HC diet ( 53 % carbohydrate , 17 % protein , and 30 % fat [ for 24 weeks . The outcomes measured were as follows : glycosylated hemoglobin ( HbA1c ) , glycemic variability ( GV ; assessed by 48-h continuous glucose monitoring ) , antiglycemic medication changes ( antiglycemic medication effects score [ MES ] ) , and blood lipids and pressure . RESULTS A total of 93 participants completed 24 weeks . Both groups achieved similar completion rates ( LC 79 % , HC 82 % ) and weight loss ( LC −12.0 ± 6.3 kg , HC −11.5 ± 5.5 kg ) ; P ≥ 0.50 . Blood pressure ( −9.8/−7.3 ± 11.6/6.8 mmHg ) , fasting blood glucose ( −1.4 ± 2.3 mmol/L ) , and LDL cholesterol ( −0.3 ± 0.6 mmol/L ) decreased , with no diet effect ( P ≥ 0.10 ) . LC achieved greater reductions in triglycerides ( −0.5 ± 0.5 vs. −0.1 ± 0.5 mmol/L ) , MES ( −0.5 ± 0.5 vs. −0.2 ± 0.5 ) , and GV indices ; P ≤ 0.03 . LC induced greater HbA1c reductions ( −2.6 ± 1.0 % [ −28.4 ± 10.9 mmol/mol ] vs. −1.9 ± 1.2 % [ −20.8 ± 13.1 mmol/mol ] ; P = 0.002 ) and HDL cholesterol ( HDL-C ) increases ( 0.2 ± 0.3 vs. 0.05 ± 0.2 mmol/L ; P = 0.007 ) in participants with the respective baseline values HbA1c > 7.8 % ( 62 mmol/mol ) and HDL-C improvements for several clinical glycemic control and CVD risk markers . These improvements and reductions in GV and antiglycemic medication requirements were greatest with the LC compared with HC . This suggests an LC diet with low saturated fat may be an effective dietary approach for T2DM management if effects are sustained beyond 24 weeks",
"ABBREVIATIONS A1C = hemoglobin A1C ; AACE = American Association of Clinical Endocrinologists ; ACCORD = Action to Control Cardiovascular Risk in Diabetes ; ACCORD BP = Action to Control Cardiovascular Risk in Diabetes Blood Pressure ; ACE = American College of Endocrinology ; ACEI = angiotensin-converting enzyme inhibitor ; AGI = alpha-glucosidase inhibitor ; apo B = apolipoprotein B ; ARB = angiotensin II receptor blocker ; ASCVD = atherosclerotic cardiovascular disease ; BAS = bile acid sequestrant ; BMI = body mass index ; BP = blood pressure ; CCB = calcium channel blocker ; CGM = continuous glucose monitoring ; CHD = coronary heart disease ; CKD = chronic kidney disease ; DKA = diabetic ketoacidosis ; DPP4 = dipeptidyl peptidase 4 ; eGFR = estimated glomerular filtration rate ; EPA = eicosapentaenoic acid ; ER = extended release ; FDA = Food and Drug Administration ; GLP1 = glucagon-like peptide 1 ; HDL-C = high-density-lipoprotein cholesterol ; HeFH = heterozygous familial hypercholesterolemia ; LDL-C = low-density-lipoprotein cholesterol ; LDL-P = low-density-lipoprotein particle ; Look AHEAD = Look Action for Health in Diabetes ; NPH = neutral protamine Hagedorn ; OSA = obstructive sleep apnea ; PCSK9 = proprotein convertase subtilisin-kexin type 9 serine protease ; RCT = r and omized controlled trial ; SU = sulfonylurea ; SGLT2 = sodium-glucose cotransporter 2 ; SMBG = self-monitoring of blood glucose ; T2D = type 2 diabetes ; TZD = thiazolidinedione",
"AIMS Little is known about the long-term association between low-carbohydrate diets ( LCDs ) and mortality . We evaluated the link between LCD and overall or cause-specific mortality using both individual data and pooled prospect i ve studies . METHODS AND RESULTS Data on diets from the National Health and Nutrition Examination Survey ( NHANES ; 1999 - 2010 ) were analysed . Multivariable Cox proportional hazards were applied to determine the hazard ratios and 95 % confidence intervals ( CIs ) for mortality for each quartile of the LCD score , with the lowest quartile ( Q1-with the highest carbohydrates intake ) used as reference . We used adjusted Cox regression to determine the risk ratio ( RR ) and 95 % CI , as well as r and om effects models and generic inverse variance methods to synthesize quantitative and pooled data , followed by a leave-one-out method for sensitivity analysis . Overall , 24 825 participants from NHANES study were included ( mean follow-up 6.4 years ) . After adjustment , participants with the lowest carbohydrates intake ( quartile 4 of LCD ) had the highest risk of overall ( 32 % ) , cardiovascular disease ( CVD ) ( 50 % ) , cerebrovascular ( 51 % ) , and cancer ( 36 % ) mortality . In the same model , the association between LCD and overall mortality was stronger in the non-obese ( 48 % ) than in the obese ( 19 % ) participants . Findings on pooled data of nine prospect i ve cohort studies with 462 934 participants ( mean follow-up 16.1 years ) indicated a positive association between LCD and overall ( RR 1.22 , 95 % CI 1.06 - 1.39 , P CVD ( RR 1.13 , 95 % CI 1.02 - 1.24 , P cancer mortality ( RR 1.08 , 95 % CI 1.01 - 1.14 , P = 0.02 , I2 = 10.3 ) . These findings were robust in sensitivity analyses . CONCLUSION Our study suggests a potentially unfavourable association of LCD with overall and cause-specific mortality , based on both new analyses of an established cohort and by pooling previous cohort studies . Given the nature of the study , causality can not be proven ; we can not rule out residual bias . Nevertheless , further studies are needed to extend these important findings , which if confirmed , may suggest a need to rethink recommendations for LCD in clinical practice",
"BACKGROUND The high-fat ketogenic diet ( KD ) has become an increasingly popular diet not only in overweight/obese population s , or those with clinical conditions , but also in healthy non-overweight population s. OBJECTIVE Because there are concerns about the association between high-fat diets and cognitive decline , this study aim ed to determine the effects of a KD compared with an isocaloric high-carbohydrate , low-fat ( HCLF ) diet on cognitive function , sleep , and mood in healthy , normal-weight individuals . METHODS Eleven healthy , normal-weight participants ( mean age : 30 ± 9 y ) completed this r and omized , controlled , crossover study . Participants followed 2 isocaloric diets-an HCLF diet ( 55 % carbohydrate , 20 % fat , and 25 % protein ) and a KD ( 15 % carbohydrate , 60 % fat , and 25 % protein)-in a r and omized order for a minimum of 3 wk , with a 1-wk washout period between diets . Measures of β-hydroxybutyrate confirmed that all participants were in a state of nutritional ketosis during post-KD assessment s ( baseline : 0.2 ± 0.2 mmol/L ; KD : 1.0 ± 0.5 mmol/L ; washout : 0.2 ± 0.1 mmol/L ; and HCLF : 0.3 ± 0.2 mmol/L ) . Cognitive function was assessed using a vali date d , psychological computer-based test battery before and after each diet . Subjective measures of mood and sleep were also monitored throughout the study using vali date d scales . RESULTS Three weeks of sustained nutritional ketosis , compared with the HCLF diet , had no effect on speed and accuracy responses in tasks design ed to measure vigilance ( speed : P = 0.39 , Cohen 's d = 0.26 ; accuracy : P = 0.99 , Cohen 's d = 0.04 ) , visual learning and memory ( speed : P = 0.99 , Cohen 's d = 0.04 ; accuracy : P = 0.99 , Cohen 's d = 0.03 ) , working memory ( speed : P = 0.62 , Cohen 's d = 0.26 ; accuracy : P = 0.98 , Cohen 's d = 0.07 ) , and executive function ( speed : P = 0.60 , Cohen 's d = 0.31 ; accuracy : P = 0.90 , Cohen 's d = 0.19 ) . Likewise , mood , sleep quality , and morning vigilance did not differ ( P > 0.05 ) between the dietary interventions . CONCLUSION The results of our r and omized , crossover , controlled study suggest that 3 wk of sustained nutritional ketosis had no effect on cognitive performance , mood , or subjective sleep quality in a sample of healthy individuals . This trial was registered in the Pan African Clinical Trial Registry as PACTR201707002406306",
"This summer , 25 overweight and obese adults participating in a tightly controlled feeding study will take up fulltime residence for 3 months at a wooded lakefront center in Ashl and , Massachusetts . However , before checking in at Framingham State University ’s Warren Conference Center and Inn , they will have to lose 15 % of their body weight on a calorie-restricted diet with home-delivered meals . Those who pass this hurdle will be invited to the inn , where they ’ll be r and omly assigned to 1 of 3 equal-calorie diets : a lowfat , high-carbohydrate diet that ’s either high or low in added sugar or a very lowcarbohydrate , high-fat ketogenic diet that causes the body to switch from burning carbohydrates to burning fat . The group will be the first of 5 that will participate in the trial over 3 years . Changes in body fat mass and energy expenditure will be assessed to determine if any of the diets have a unique effect on metabolism , while controlling calorie intake , in people who have already lost weight . “ It ’s hard to lose weight , but it ’s much harder to maintain that weight loss because of well-described physiological adaptations , ” said coprincipal investigator David S. Ludwig , MD , PhD , a professor of pediatrics and nutrition at Harvard Medical School and Harvard T.H. Chan School of Public Health . After most diet-induced weight loss , “ hunger goes up and metabolic rate goes down , and tendency to restore fat increases . ” But there are hints that the ketogenic diet may be different . A meta- analysis of 13 r and omized controlled trials suggested that people on ketogenic diets tend to lose more weight and keep more of it off than people on low-fat diets . People placed on these diets often report decreased hunger , according to Amy Miskimon Goss , PhD , RD , an assistant professor at the University of Alabama at Birmingham ( UAB ) Nutrition Obesity Research Center . The appetitesuppressing powers of the diet are n’t fully understood but could have to do with the satiating properties of fat and protein , changes in appetite-regulating hormones on a low-carb diet , a direct hunger-reducing role of ketone bodies— the body ’s main fuel source on the diet — or other factors . Additionally , the ketogenic diet may not affect metabolism the same way other diets do . In a previous study , Ludwig found that metabolism slowed by more than 400 kcal/d on a low-fat diet while there was no significant decline in metabolic rate on a very low-carb diet . Medical News & Perspectives ........",
"Importance Dietary modification remains key to successful weight loss . Yet , no one dietary strategy is consistently superior to others for the general population . Previous research suggests genotype or insulin-glucose dynamics may modify the effects of diets . Objective To determine the effect of a healthy low-fat ( HLF ) diet vs a healthy low-carbohydrate ( HLC ) diet on weight change and if genotype pattern or insulin secretion are related to the dietary effects on weight loss . Design , Setting , and Participants The Diet Intervention Examining The Factors Interacting with Treatment Success ( DIETFITS ) r and omized clinical trial included 609 adults aged 18 to 50 years without diabetes with a body mass index between 28 and 40 . The trial enrollment was from January 29 , 2013 , through April 14 , 2015 ; the date of final follow-up was May 16 , 2016 . Participants were r and omized to the 12-month HLF or HLC diet . The study also tested whether 3 single-nucleotide polymorphism multilocus genotype responsiveness patterns or insulin secretion ( INS-30 ; blood concentration of insulin 30 minutes after a glucose challenge ) were associated with weight loss . Interventions Health educators delivered the behavior modification intervention to HLF ( n = 305 ) and HLC ( n = 304 ) participants via 22 diet-specific small group sessions administered over 12 months . The sessions focused on ways to achieve the lowest fat or carbohydrate intake that could be maintained long-term and emphasized diet quality . Main Outcomes and Measures Primary outcome was 12-month weight change and determination of whether there were significant interactions among diet type and genotype pattern , diet and insulin secretion , and diet and weight loss . Results Among 609 participants r and omized ( mean age , 40 [ SD , 7 ] years ; 57 % women ; mean body mass index , 33 [ SD , 3 ] ; 244 [ 40 % ] had a low-fat genotype ; 180 [ 30 % ] had a low-carbohydrate genotype ; mean baseline INS-30 , 93 & mgr;IU/mL ) , 481 ( 79 % ) completed the trial . In the HLF vs HLC diets , respectively , the mean 12-month macronutrient distributions were 48 % vs 30 % for carbohydrates , 29 % vs 45 % for fat , and 21 % vs 23 % for protein . Weight change at 12 months was −5.3 kg for the HLF diet vs −6.0 kg for the HLC diet ( mean between-group difference , 0.7 kg [ 95 % CI , −0.2 to 1.6 kg ] ) . There was no significant diet-genotype pattern interaction ( P = .20 ) or diet-insulin secretion ( INS-30 ) interaction ( P = .47 ) with 12-month weight loss . There were 18 adverse events or serious adverse events that were evenly distributed across the 2 diet groups . Conclusions and Relevance In this 12-month weight loss diet study , there was no significant difference in weight change between a healthy low-fat diet vs a healthy low-carbohydrate diet , and neither genotype pattern nor baseline insulin secretion was associated with the dietary effects on weight loss . In the context of these 2 common weight loss diet approaches , neither of the 2 hypothesized predisposing factors was helpful in identifying which diet was better for whom . Trial Registration clinical trials.gov Identifier :"
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41174150-06ff-11f0-808a-c43d1ab1c353
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Background The twelve-item Self-Report Habit Index ( SRHI ) is the most popular measure of energy-balance related habits . This measure characterises habit by automatic activation , behavioural frequency , and relevance to self-identity . Previous empirical research suggests that the SRHI may be abbreviated with no losses in reliability or predictive utility . Drawing on recent theorising suggesting that automaticity is the ‘ active ingredient ’ of habit-behaviour relationships , we tested whether an automaticity-specific SRHI subscale could capture habit-based behaviour patterns in self-report data . Methods A content validity task was undertaken to identify a subset of automaticity indicators within the SRHI . The reliability , convergent validity and predictive validity of the automaticity item subset was subsequently tested in secondary analyses of all previous SRHI applications , identified via systematic review , and in primary analyses of four raw data sets relating to energy‐balance relevant behaviours ( inactive travel , active travel , snacking , and alcohol consumption ) . Results A four-item automaticity subscale ( the ‘ Self-Report Behavioural Automaticity Index ’ ; ‘ SRBAI ’ ) was found to be reliable and sensitive to two hypothesised effects of habit on behaviour : a habit-behaviour correlation , and a moderating effect of habit on the intention-behaviour relationship . Conclusion The SRBAI offers a parsimonious measure that adequately captures habitual behaviour patterns . The SRBAI may be of particular utility in predicting future behaviour and in studies tracking habit formation or disruption
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"OBJECTIVE To evaluate the feasibility and effectiveness of a pilot family-based newsletter intervention to increase fruit and vegetable ( FV ) consumption among adolescents . DESIGN Family-based , two-group r and omised control trial with baseline , post-intervention and follow-up measures . The intervention group received two FV newsletter packs over a 1 month period by postal mail . Social cognitive and behavioural choice theories provide the theoretical framework for the design and development of intervention material s. Control families were provided with all intervention material s at the end of the study . Adolescent FV consumption was assessed by an FFQ . Adolescent-reported barriers to eating FV , FV habits and preferences were the secondary outcomes , along with parent FV consumption , and parents reported knowledge , encouragement , home availability and accessibility of FV . Repeated- measures ANOVA was used to detect differences in behavioural and psychosocial outcomes between groups , time and group-by-time . SETTING East Midl and s , UK . SUBJECTS Forty-nine parents and adolescents aged 12 - 14 years . RESULTS Process evaluation indicated high reach , dose acceptability and fidelity of the intervention . At post-intervention and 6 weeks later at follow-up , adolescents in the intervention group had significantly higher fruit : ( P ( P higher fruit ( P and reported higher accessibility of fruit and vegetables ( P Family-based , newsletter interventions promoting FV consumption to adolescents appear to be feasible and effective at increasing FV consumption",
"The authors tested and confirmed the hypothesis that priming a stereotype or trait leads to complex overt behavior in line with this activated stereotype or trait . Specifically , 4 experiments established that priming the stereotype of professors or the trait intelligent enhanced participants ' performance on a scale measuring general knowledge . Also , priming the stereotype of soccer hooligans or the trait stupid reduced participants ' performance on a general knowledge scale . Results of the experiments revealed ( a ) that prolonged priming leads to more pronounced behavioral effects and ( b ) that there is no sign of decay of the effects for at least 15 min . The authors explain their results by cl aim ing that perception had a direct and pervasive impact on overt behavior ( cf . J.A. Bargh , M. Chen , & L. Burrows , 1996 ) . Implication s for human social behavior are discussed",
"Background In recent years , there has been growing interest in theoretical studies integrating cognitions and environmental variables in the prediction of behaviour related to the obesity epidemic . This is the approach adopted in the present study in reference to the theory of planned behaviour . More precisely , the aim of this study was to determine the contribution of cognitive and environmental variables in the prediction of active commuting to get to and from work or school . Methods A prospect i ve study was carried out with 130 undergraduate and graduate students ( 93 females ; 37 males ) . Environmental , cognitive and socio-demographic variables were evaluated at baseline by question naire . Two weeks later , active commuting ( walking/bicycling ) to get to and from work or school was self-reported by question naire . Hierarchical multiple regression analyses were performed to predict intention and behaviour . Results The model predicting behaviour based on cognitive variables explained more variance than the model based on environmental variables ( 37.4 % versus 26.8 % ; Z = 3.86 , p intention , habit and age . Concerning intention , the same procedure yielded a final model explaining 78.2 % ( p perceived behavioural control , attitude and habit being the significant determinants . Conclusion The results showed that cognitive variables play a more important role than environmental variables in predicting and explaining active commuting . When environmental variables were significant , they were mediated by cognitive variables . Therefore , individual cognitions should remain one of the main focuses of interventions promoting active commuting among undergraduate and graduate students",
"Objective : To evaluate the efficacy of a simple weight loss intervention , based on principles of habit formation . Design : An exploratory trial in which overweight and obese adults were r and omized either to a habit-based intervention condition ( with two subgroups given weekly vs monthly weighing ; n=33 , n=36 ) or to a waiting-list control condition ( n=35 ) over 8 weeks . Intervention participants were followed up for 8 months . Participants : A total of 104 adults ( 35 men , 69 women ) with an average BMI of 30.9 kg m−2.Intervention : Intervention participants were given a leaflet containing advice on habit formation and simple recommendations for eating and activity behaviours promoting negative energy balance , together with a self-monitoring checklist . Main outcome measures : Weight change over 8 weeks in the intervention condition compared with the control condition and weight loss maintenance over 32 weeks in the intervention condition . Results : At 8 weeks , people in the intervention condition had lost significantly more weight ( mean=2.0 kg ) than those in the control condition ( 0.4 kg ) , with no difference between weekly and monthly weighing subgroups . At 32 weeks , those who remained in the study had lost an average of 3.8 kg , with 54 % losing 5 % or more of their body weight . An intention-to-treat analysis ( based on last-observation-carried-forward ) reduced this to 2.6 kg , with 26 % achieving a 5 % weight loss . Conclusions : This easily disseminable , low-cost , simple intervention produced clinical ly significant weight loss . In limited re source setting s it has potential as a tool for obesity management",
"OBJECTIVES Repeated action can lead to the formation of habits and identification as ' the kind of person ' that performs the behaviour . This has led to the suggestion that identity- relevance is a facet of habit . This study explores conceptual overlap between habit and identity , and examines where the two constructs fit into an extended Theory of Planned Behaviour ( TPB ) model of binge-drinking among university students . DESIGN Prospect i ve , question naire-based correlational design . METHODS A total of 167 UK university students completed baseline measures of past behaviour , self-identity , the Self-Report Habit Index ( SRHI ) , and TPB constructs . One week later , 128 participants completed a follow-up behaviour measure . RESULTS Factor analyses of the SRHI and four identity items revealed two correlated but distinct factors , relating to habit and identity , respectively . Hierarchical regression analyses of intention and behaviour showed that identity contributed over and above TPB constructs to the prediction of intention , whereas habit predicted behaviour directly , and interacted with intentions in predicting behaviour . Habits unexpectedly strengthened the intention-behaviour relation , such that strong intenders were more likely to binge-drink where they also had strong habits . CONCLUSIONS Identity and habit are conceptually discrete and impact differently on binge-drinking . Findings have implication s for habit theory and measurement . Recommendations for student alcohol consumption reduction initiatives are offered",
"Interventions to promote physical activity are important in preventing children from becoming overweight . Many projects have been developed but only a few showed ( moderate ) effects . JUMP-in is a systematic ally developed primary -school-based intervention that focuses on the use of theory , environmental changes , parental influences and cooperation with multi-level parties in intervention development . The effects of JUMP-in were evaluated with a quasi-experimental pre-test/post-test research design . In total , 510 children from Grade s 4 , 5 and 6 of four intervention schools and two control schools in Amsterdam were followed for an intervention period of one school year . Changes in physical activity as well as in the social cognitive determinants were assessed using self-reports . In addition , a process evaluation has been executed . The results show that JUMP-in was effective in influencing physical activity , especially among children from Grade 6 . Children in the control group decreased their level of physical activity considerably , while activity levels in intervention children from Grade 6 remained stable . The intervention effects could not be explained by changes in the measured social cognitive determinants . In contrast , process information illuminated differences in intervention effects between the participating schools . The results from the JUMP-in study show the importance of intervention design s that focus on a theory-based mix of relevant environmental and social cognitive factors",
"OBJECTIVE Habit might be usefully characterized as a form of automaticity that involves the association of a cue and a response . Three studies examined habitual automaticity in regard to different aspects of the cue-response relationship characteristic of unhealthy and healthy habits . DESIGN , MAIN OUTCOME MEASURES , AND RESULTS In each study , habitual automaticity was assessed by the Self-Report Habit Index ( SRHI ) . In Study 1 SRHI scores correlated with attentional bias to smoking cues in a Stroop task . Study 2 examined the ability of a habit cue to elicit an unwanted habit response . In a prospect i ve field study , habitual automaticity in relation to smoking when drinking alcohol in a licensed public house ( pub ) predicted the likelihood of cigarette-related action slips 2 months later after smoking in pubs had become illegal . In Study 3 experimental group participants formed an implementation intention to floss in response to a specified situational cue . Habitual automaticity of dental flossing was rapidly enhanced compared to controls . CONCLUSION The studies provided three different demonstrations of the importance of cues in the automatic operation of habits . Habitual automaticity assessed by the SRHI captured aspects of a habit that go beyond mere frequency or consistency of the behavior",
"OBJECTIVE To study predictors of fruit intake in a sample of 627 adults . DESIGN Potential predictors of fruit intake were assessed at baseline , and fruit intake was assessed at two-week follow-up with self-administered question naires distributed by e-mail . SETTING The study was conducted among Dutch adult members of an Internet research panel . PARTICIPANTS A r and om sample of 627 adults aged 18 - 78 . VARIABLES MEASURED Attitudes , subjective norms , self-efficacy , expected pros and cons , habit strength , intention , and fruit intake . Fruit intake was assessed with a vali date d food-frequency question naire . ANALYSIS Hierarchical linear and logistic regression analyses . Alpha self-efficacy expectations , and habit strength were significantly associated with the intention to eat two or more servings of fruit per day . Age , intentions , and habit strength were significant predictors of consumption of two or more servings of fruit per day . CONCLUSIONS AND IMPLICATION S The results confirm that Theory of Planned Behavior constructs predict fruit intake , and that habit strength and different self-efficacy expectations may be additional determinants relevant to fruit intake . Because habitual behavior is considered to be triggered by environmental cues , fruit promotion interventions should further explore environmental change strategies",
"Objective : This study examined whether matching implementation intentions to people ’s regulatory orientation affects the effectiveness of changing unhealthy snacking habits . Design : Participants ’ regulatory orientation was either measured ( as a chronic trait ) or manipulated ( as a situational state ) , and participants were r and omly assigned to implementation intention conditions to eat more healthy snacks or avoid eating unhealthy ones . Main outcome measures : A self-reported online food diary of healthy and unhealthy snacks over a two-day period . Results : Participants with weak unhealthy snacking habits consumed more healthy snacks when forming implementation intentions ( regardless of match or mismatch with their regulatory orientation ) , while participants with strong unhealthy snacking habits consumed more healthy snacks only when forming implementation intentions that matched their regulatory orientations . Conclusion : Results suggest that implementation intentions that match regulatory orientation heighten motivation intensity and put snacking under intentional control for people with strong unhealthy snacking habits "
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4117418c-06ff-11f0-808a-c43d1ab1c353
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& NA ; A growing body of evidence suggests that our diet is an important contributing factor in the development , management and prevention of a number of psychiatric illnesses . Tryptophan , an essential amino acid , is the sole precursor of neurotransmitter 5‐hydroxytryptamine ( 5‐HT ; serotonin ) . Administration of tryptophan can boost serotonin neurotransmission to produce therapeutically important effects in serotonin deficiency disorders . Anorexia nervosa ( AN ) an eating disorder associated with high levels of psychiatric comorbidity including psychosis , hyperactivity , depression and anxiety has highest lethality of all psychiatric illnesses . Evidence suggests that excessive dieting and food restriction can decrease brain tryptophan and serotonin in AN patients to precipitate depression , psychosis and hyperactivity . There are currently no FDA approved pharmacological treatments available for AN patients ; antidepressants and antipsychotics , largely used to treat associated psychiatric comorbidities are also not very effective . The aim of this non‐ systematic review article is to evaluate and document a potential importance of tryptophan supplementation in improving therapeutics in AN patients . Graphical abstract Excessive dieting‐induced nutritional deficiency of tryptophan : Effects on behavior and efficacy of antipsychotic and antidepressant medication . Figure . No caption available
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"CONTEXT Antidepressant medication is frequently prescribed for patients with anorexia nervosa . OBJECTIVE To determine whether fluoxetine can promote recovery and prolong time-to-relapse among patients with anorexia nervosa following weight restoration . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial . From January 2000 until May 2005 , 93 patients with anorexia nervosa received intensive inpatient or day-program treatment at the New York State Psychiatric Institute or Toronto General Hospital . Participants regained weight to a minimum body mass index ( calculated as weight in kilograms divided by the square of height in meters ) of 19.0 and were then eligible to participate in the r and omized phase of the trial . INTERVENTIONS Participants were r and omly assigned to receive fluoxetine or placebo and were treated for up to 1 year as out patients in double-blind fashion . All patients also received individual cognitive behavioral therapy . MAIN OUTCOME MEASURES The primary outcome measures were time-to-relapse and the proportion of patients successfully completing 1 year of treatment . RESULTS Forty-nine patients were assigned to fluoxetine and 44 to placebo . Similar percentages of patients assigned to fluoxetine and to placebo maintained a body mass index of at least 18.5 and remained in the study for 52 weeks ( fluoxetine , 26.5 % ; placebo , 31.5 % ; P = .57 ) . In a Cox proportional hazards analysis , with prer and omization body mass index , site , and diagnostic subtype as covariates , there was no significant difference between fluoxetine and placebo in time-to-relapse ( hazard ratio , 1.12 ; 95 % CI , 0.65 - 2.01 ; P = .64 ) . CONCLUSIONS This study failed to demonstrate any benefit from fluoxetine in the treatment of patients with anorexia nervosa following weight restoration . Future efforts should focus on developing new models to underst and the persistence of this illness and on exploring new psychological and pharmacological treatment approaches . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00288574",
"OBJECTIVE Selective serotonin reuptake inhibitor ( SSRI ) medication does not appear to be effective in ill , malnourished anorexia nervosa ( AN ) patients . However , it may be effective in preventing relapse after weight restoration . The purpose of this study was to determine whether nutritional supplements could potentiate the effects of fluoxetine in underweight AN subjects . METHOD Twenty-six subjects with AN participated in a trial of fluoxetine . In a double-blind , placebo-controlled manner , subjects received either nutritional supplements or a nutritional placebo . The nutritional supplement included tryptophan ( the precursor of serotonin ) , vitamins , minerals , and essential fatty acids believed to influence serotonin pathway function . RESULTS There was no significant difference in weight gain between subjects treated with fluoxetine plus nutritional supplements versus fluoxetine plus a nutritional placebo . Moreover , there were no significant differences between groups on mean changes in anxiety or obsessive and compulsive symptoms . DISCUSSION The results of this study suggest that supplement strategies are not a substitute for adequate nutrition and are ineffective in increasing the efficacy of fluoxetine in underweight AN subjects",
"UNLABELLED The salience network ( SN ) , a set of brain regions composed of the anterior fronto-insular cortex ( aFI ) and the anterior cingulate cortex ( ACC ) , is usually involved in interoception , self-regulating , and action selection . Accumulating evidence indicates that dysfunctions in this network are associated with various pathophysiological deficits in both schizophrenia and eating disorders , stemming mainly from dysfunctional information processing of internal or external stimuli . In addition , the metabolic side effects of some antipsychotics ( APs ) , as well as their pharmacological mechanisms of action , also suggest a link between the functional and neurophysiological changes in the brain in both schizophrenia and in eating disorders . Nevertheless , there is still a knowledge gap in explicitly and directly linking the metabolic side effects associated with AP treatment with the dysfunction in SN associated with processing of food-related information in schizophrenia . Here we provide neuroimaging evidence for such a link , by presenting data on a group of schizophrenia patients who followed 16 weeks of olanzapine treatment and undertook a passive viewing task while their brain activity was recorded . In response to food-related dynamic stimuli ( video clips ) , we observed a decreased activity in SN ( aFI and ACC ) after the treatment , which also correlated with ghrelin plasma concentration and a measure of dietary restraint . Taken together with past findings regarding the role of SN in both schizophrenia and eating disorders , our results suggest that enhancing the reactivity in the SN has the potential to be a treatment strategy in people with anorexia nervosa . CLINICAL TRIAL REGISTRATION NUMBER NCT 00290121",
"BACKGROUND The delivery of circulating tryptophan to the brain and its conversion to serotonin vary directly with plasma concentrations of tryptophan and inversely with those of other large neutral amino acids ( LNAAs ) . Although carbohydrate-rich , protein-free formula diets have been shown to elevate , and high-protein diets to depress , the tryptophan-LNAA ratio , few data are available about this ratio 's responses to actual meals . OBJECTIVE We determined whether carbohydrate-rich or protein-rich breakfasts , such as those Americans normally eat , produce substantial differences in the plasma tryptophan-LNAA ratio and in the corresponding ratio for tyrosine , the precursor of brain dopamine and norepinephrine . DESIGN Nine overnight-fasted subjects consumed , 3 - 7 d apart , a carbohydrate-rich ( 69.9 g carbohydrate and 5.2 g protein ) and a protein-rich ( 15.4 g carbohydrate and 46.8 g protein ) breakfast . Blood sample s collected at baseline and after 40 , 80 , 120 , and 240 min were assayed for tryptophan , tyrosine , the 5 other LNAAs , and insulin . RESULTS The carbohydrate-rich and protein-rich breakfasts had significantly different effects on both the plasma tryptophan-LNAA and tyrosine-LNAA ratios ( each P median difference for tryptophan : LNAA was 54 % ( range : 36 - 88 % ) and for tyrosine : LNAA was 28 % ( range : 10 - 64 % ) . Insulin concentrations rose significantly after the carbohydrate but not after the protein meal . CONCLUSIONS High-carbohydrate and high-protein breakfasts similar to those Americans normally eat can cause substantial differences in the plasma tryptophan ratio and thus , probably , in brain tryptophan concentrations and serotonin synthesis . Such meals also change the plasma tyrosine ratio and may thereby modify catecholamine synthesis",
"Anorexia nervosa ( AN ) is a life-threatening and difficult to treat mental illness with the highest mortality rates of any psychiatric disorder . We aim ed to garner preliminary data on the real-world use of olanzapine and aripiprazole as augmentation agents of Selective Serotonin Reuptake Inhibitors ( SSRIs ) in adult in patients affected by AN . We retrospectively evaluated the clinical charts of patients who were hospitalized between 2012 and 2014 . Patients were evaluated upon admission and discharge . We investigated eating symptomatology , and both general and eating psychopathology using : Hamilton Rating Scale for Anxiety , Hamilton Rating Scale for Depression , and Yale-Brown-Cornell Eating Disorders Scale . The charts of 75 patients were included in this study . The sample result ed equally distributed among those receiving SSRIs and either aripiprazole or olanzapine in addition to SSRIs . Notwithst and ing a few baseline clinical differences , upon discharge all groups were significantly improved on all measures . Interestingly , aripiprazole showed the greatest effectiveness in reducing eating-related preoccupations and rituals with a large effect size . The body of evidence on medication management in AN is in dismal condition . Augmentation therapy is a well-established approach to a variety of mental disorders and it is often used in every-day clinical practice with patients affected by AN as well . Nevertheless , to date very little data is available on this topic . Results from our sample yielded promising results on the effectiveness of aripiprazole augmentation in reducing eating-related obsessions and compulsions . R and omized controlled trials are warranted to confirm these encouraging findings"
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411741c8-06ff-11f0-808a-c43d1ab1c353
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This systematic review and meta- analysis aims to compare the effect of High-Glycemic Index ( GI ) versus Low-GI breakfasts on cognitive functions , including memory and attention , of children and adolescents . We systematic ally search ed the MEDLINE ( via PubMed ) , EMBASE , Cochrane Central Register of Controlled Trials , Cochrane Data base of Systematic Review s , and Web of Science data bases , from their inception until June 2019 . Articles comparing the effect of Low-GI versus High-GI breakfasts on the cognitive function ( i.e. , immediate memory , delayed memory , and attention ) of children and adolescents were included . The DerSimonian and Laird method was used to compute the pooled effect sizes ( ESs ) and their respective 95 % confidence intervals ( CIs ) . The pooled ESs were 0.13 ( 95 % CI : -0.11 , 0.37 ) for immediate memory and 0.07 ( 95 % CI : -0.15 , 0.28 ) for delayed memory . For attention , the pooled ES was -0.01 ( 95 % CI : -0.27 , 0.26 ) . In summary , GI breakfasts do not affect cognitive domains in children and adolescents
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"Abstract . Rationale : Previous investigations have demonstrated increased performance after the administration of a glucose-load on certain aspects of cognitive functioning in healthy young adults . Generally these studies have used a procedure where participants were tested in the morning after an overnight fast . Objective : The aim of the present study was , for the first time , to investigate the glucose cognitive facilitation effect under more natural testing times and with shorter duration of the previous fast . Methods : Measures of verbal and non-verbal memory performance were compared under different fasting intervals ( 2-h fast versus overnight fast ) , times ( morning versus afternoon ) and glycaemic conditions ( glucose versus aspartame drinks ) in healthy young participants . Results : There was a significant glucose facilitation effect on long-term verbal memory performance . In addition , glucose significantly enhanced long-term spatial memory performance . The effect of glucose was essentially equivalent whether it was given after an overnight fast or a 2-h fast following breakfast or lunch . There was no effect of drink and time of day on working memory performance . Conclusions : The results of this study further support the hypothesis that glucose administration can enhance certain aspects of memory performance in healthy young adults . More significantly , the findings indicate that this cognitive facilitation effect persists under more naturalistic conditions of glucose administration and is not restricted to long fast duration s or morning administration",
"The macronutrient composition of a breakfast that could facilitate performance after an overnight fast remains unclear . As glucose is the brain 's major energy source , the interest is in investigating meals differing in their blood glucose-raising potential . Findings vary due to unaccounted differences in glucoregulation , arousal and cortisol secretion . We investigated the effects of meals differing in glycaemic index ( GI ) and glycaemic load ( GL ) on cognition and mood in school children . A total of seventy-four school children were matched and r and omly allocated either to the high-GL or low-GL group . Within each GL group , children received high-GI and low-GI breakfasts . Cognitive function ( CF ) and mood were measured 95 - 140 min after breakfast . Blood glucose and salivary cortisol were measured at baseline , before and after the CF tests . Repeated- measures ANOVA was used to identify differences in CF , mood , glucose and cortisol levels between the breakfasts . Low-GI meals predicted feeling more alert and happy , and less nervous and thirsty ( P predicted feeling more confident , and less sluggish , hungry and thirsty ( P increased glucose levels 90 min after breakfast , and high-GI meals increased cortisol levels ( P baseline mood , glucose and cortisol levels were considered , low-GI meals predicted better declarative-verbal memory ( P = 0·03 ) , and high-GI meals better vigilance ( P . GI effects on cognition appear to be domain specific . On balance , it would appear that the low-GI high-GL breakfast may help to improve learning , and of potential value in informing government education policies relating to dietary recommendations and implementation concerning breakfast",
"The determine the effect of different foods on the blood glucose , 62 commonly eaten foods and sugars were fed individually to groups of 5 to 10 healthy fasting volunteers . Blood glucose levels were measured over 2 h , and expressed as a percentage of the area under the glucose response curve when the same amount of carbohydrate was taken as glucose . The largest rises were seen with vegetables ( 70 + /- 5 % ) , followed by breakfast cereals ( 65 + /- 5 % ) , cereals and biscuits ( 60 + /- 3 % ) , fruit ( 50 + /- 5 % ) , dairy products ( 35 + /- 1 % ) , and dried legumes ( 31 + /- 3 % ) . A significant negative relationship was seen between fat ( p less than 0.01 ) and protein ( p less than 0.001 ) and postpr and ial glucose rise but not with fiber or sugar content",
"Effects of skipping breakfast on speed and accuracy of response in a number of problem solving tasks were assessed in 9- to 11-yr-old , well-nourished children . The conceptual framework for this study was derived from an experimental model of the effects of mild environmental stress , e.g. , noise , on human performance . Plasma glucose , beta-hydroxybutyrate , lactate , and free fatty acids were used as indicators of the induced metabolic stress , and the extent of their association with the behavioral measures was determined . Fasting had an adverse effect on the accuracy of responses in problem solving , but it had a beneficial effect on immediate recall in short-term memory . Both effects are explained by a heightened arousal level associated with the brief experimental fast",
"Background / Objectives : Considering the importance of glucose as a brain substrate , the postpr and ial rate of glucose delivery to the blood could be expected to affect cognitive functions . The purpose was to evaluate to what extent the rate of glucose absorption affected measures of cognitive performance in the postpr and ial period . In addition , cognitive performance was evaluated in relation to individual glucoregulation . Subjects/ Methods : A white wheat bread ( WWB ) enriched with guar gum ( G-WWB ) with the capacity to produce a low but sustained blood glucose net increment was developed . The G-WWB was evaluated in the postpr and ial period after breakfast with respect to effects on cognitive function ( working memory and selective attention ( SA ) ) in 40 healthy adults ( 49–71 years , body mass index 20–29 kg/m2 ) , using a high glycaemic index WWB for comparison in a r and omised crossover design . Results : The G-WWB improved outcome in the cognitive tests ( SA test ) in the later postpr and ial period ( 75–225 min ) in comparison with the WWB ( P cognitive tests compared with subjects with worse glucoregulation ( P cognitive performance were observed with the G-WWB in the late postpr and ial period . The positive effect is suggested to emanate from improved insulin sensitivity , possibly in a combination with an enhanced neural energy supply . The results highlight the importance of carbohydrate foods that induces a low but sustained blood glucose profile in enhancing postpr and ial cognitive functions ",
"Twenty-nine schoolchildren were tested throughout the morning on 4 successive days , having a different breakfast each day ( either of the cereals Cheerios or Shreddies , glucose drink or No breakfast ) . A series of computerised tests of attention , working memory and episodic secondary memory was conducted prior to breakfast and again 30 , 90 , 150 and 210 min later . The glucose drink and No breakfast conditions were followed by declines in attention and memory , but the declines were significantly reduced in the two cereal conditions . This study provides objective evidence that a typical breakfast of cereal rich in complex carbohydrates can help maintain mental performance over the morning",
"Background / Objectives : The effect of Glycaemic Index ( GI ) and Load ( GL ) of breakfasts on satiety and aspects of cognitive function in children is inconclusive . We aim ed to assess if isocaloric breakfasts differing in GL ( by replacing high-GI carbohydrate foods with dairy protein foods ) acutely alter cognitive function and satiety in 10- to 12-year-old children . Subjects/ Methods : A total of 39 children , aged 11.6±0.7 years with body mass index 18.9±3.0 kg/m2 ( Mean±s.e . ) participated in a r and omised crossover trial of three isocaloric breakfasts ( 1.3 MJ ) : high GL ( HGL : 7 g protein , 9 g fat , 50 g carbohydrate , GL 33 ) ; medium GL ( MGL : 14 g protein , 9 g fat , 45 g carbohydrate , GL 24 ) and low GL ( LGL : 18 g protein , 10 g fat , 38 g carbohydrate , GL 18 ) . Blood glucose was recorded using a continuous glucose monitor . Subjective hunger and cognitive performance were measured before and hourly after consuming the test breakfast via a computer-delivered battery . Ad libitum intake at a buffet lunch meal was measured at 3 h at the end of testing . Results : Incremental area under the glucose curve ( iAUC ) was significantly different with HGL > MGL > LGL ( P ) . Glucose concentrations fell below baseline after 83±6 min for HGL , 63±5 min ( MGL ) and 67±5 min (LGL)(P=0.009 ) . Breakfast GL did not significantly alter changes in cognitive function or self-reported satiety throughout testing . Energy intake at lunch was not significantly different between treatments ( HGL 2943±168 kJ ; MGL 2949±166 kJ ; LGL 2993±191 kJ ) . Conclusions : Reducing breakfast GL by replacing carbohydrate with protein does not alter satiety or cognition over 3 h in 10- to 12-year-old children",
"The aim of the present study was to examine the combined effects of breakfast glycaemic index ( GI ) and a mid-morning bout of exercise on adolescents ' cognitive function . Participants were r and omly allocated to a high or low GI breakfast group in a mixed research design , where each participant completed two experimental trials ( exercise and resting ) . Forty-two adolescents ( 12.4±0.5 years old ) , undertook a bout of exercise ( ten repeats of level one of the multi-stage fitness test ; exercise trial ) or continued to rest ( resting trial ) following consumption of either a high or low GI breakfast . A battery of cognitive function tests ( visual search test , Stroop test and Sternberg paradigm ) was completed 30 min before and 45 min following the exercise . Average heart rate during exercise was 170±15 beats·min(-1 ) . On the complex level of the Stroop test , response times improved across the morning following the low GI breakfast on both the exercise and resting trials , though the improvement was greatest on the exercise trial . However , response times only improved on the resting trial following the high GI breakfast ( p=0.012 ) . On the 5 letter level of the Sternberg paradigm , response times improved across the morning following the low GI breakfast ( regardless of exercise ) and only on the exercise trial following the high GI breakfast ( p=0.019 ) . The findings of the present study suggest that the combined effects of breakfast GI and exercise in adolescents depend upon the component of cognitive function examined . A low GI breakfast and mid-morning bout of exercise were individually beneficial for response times on the Sternberg paradigm , whereas they conferred additional benefits for response times on the Stroop test",
"Rationale . Glucose is the main metabolic fuel of the brain . The rate of glucose delivery from food to the bloodstream depends on the nature of carbohydrates in the diet , which can be summarized as the glycaemic index ( GI ) . Objectives . To assess the benefit of a low versus high GI breakfast on cognitive performances within the following 4 h. Methods . The influence of the GI of the breakfast on verbal memory of young adults was measured throughout the morning in parallel to the assessment of blood glucose levels . The learning abilities of rats performing an operant-conditioning test 3 h after a breakfast-like meal of various GI was also examined . Results . A low GI rather than high GI diet improved memory in humans , especially in the late morning ( 150 and 210 min after breakfast ) . Similarly , rats displayed better learning performance 180 min after they were fed with a low rather than high GI diet . Conclusion . Although performances appeared to be only remotely related to blood glucose , our data provide evidence that a low GI breakfast allows better cognitive performances later in the morning",
"Previously it has been found that both missing breakfast and having poorer glucose tolerance were associated with better memory . The present study therefore examined the impact of eight breakfasts , in a factorial design , that contained either high or low levels of carbohydrate , fat or protein . The meals were design ed to vary the rate of release of glucose into the blood stream . Memory , reaction times and vigilance were assessed 30 , 75 and 120 min following breakfast . Using fasting blood glucose levels as a measure of glucose tolerance , better memory was found to be associated with better glucose tolerance and the consumption of meals that more slowly release glucose into the blood . The effects of the meals on reaction times and vigilance were opposite to those with memory in that higher levels of blood glucose tended to be associated with better performance . It was concluded that individual differences in glucose tolerance interact with the glycaemic load of a meal to influence cognitive functioning",
"There is evidence from animal studies that increased blood glucose levels are associated with improved memory and attention . Although previous studies have found human memory to be facilitated by the administration of glucose , attentional measures have been largely ignored . Therefore the impact of a glucose drink , or a placebo , on the Rapid Information Processing Task and the Stroop Task was examined . The reaction times of those taking the Rapid Information Processing Task were faster both during the baseline period and after a glucose drink if the blood glucose values were high . With the Stroop task the ability to perform the most cognitively dem and ing sub-test was selectively enhanced if blood glucose values were increasing prior to starting the test . The ability to recall words from a word list was greater if a glucose drink had been consumed , although primary and recency were not differentially influenced . The possibility is discussed that higher levels of brain glucose are associated with better memory and attention"
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41174204-06ff-11f0-808a-c43d1ab1c353
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Objective Irrigant activation has been cl aim ed to be beneficial in in vitro and clinical studies . This systematic review aims to investigate the clinical efficiency of mechanically activated irrigants and conventional irrigation . Methods A literature search ( PROSPERO registration number : CRD42018112595 ) was undertaken in PubMed , Cochrane and h and search . The inclusion criteria were clinical trials , in vivo/ex vivo on adult permanent teeth involving an active irrigation device and a control group of conventional irrigation . The exclusion criteria were studies done in vitro , animals and foreign language . Adult patients requiring endodontic treatment of permanent dentition and irrigant activation during the treatment were chosen as the participants and intervention respectively . Results After removal of duplicates , 89 articles were obtained , and 72 were excluded as they did not meet the selection criteria . 6 devices ( EndoVac , EndoActivator , Ultrasonic , MDA ( manual dynamic agitation ) , CUI ( Continuous Ultrasonic Irrigation ) and PUI ( Passive Ultrasonic Irrigation ) ) and 6 variables of interest ( Post-operative pain , periapical healing , antibacterial efficacy , canal and /or isthmus cleanliness , debridement efficacy and delivery up to working length ) were evaluated in the 17 included articles . The risk of bias and quality of the selected articles were moderate . Results showed that mechanical active irrigation reduces post-operative pain . It improved debridement , canal/isthmus cleanliness . It also improved delivery of irrigant up to working length . Bacterial count was more with active irrigation , though not significant . There is no effect on long-term periapical healing . Conclusion It may be concluded that mechanical active irrigation devices are beneficial in reducing post-operative pain and improving canal and isthmus cleanliness during Endodontics
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"INTRODUCTION The extrusion of irrigation solutions beyond the apical constriction may result in postoperative pain . Sodium hypochlorite can cause severe tissue irritation and necrosis outside the root canal system if extruded into the periodontal ligament ( PDL ) space . Different delivery techniques were discussed to reduce this potential risk . The aim of this study was to compare the postoperative level of pain after root canal therapy using either endodontic needle irrigation or a negative apical pressure device . MATERIAL AND METHODS In a prospect i ve r and omized clinical trial , 110 asymptomatic single-rooted anterior and premolar teeth were treated endodontically with two different irrigation techniques . The teeth were r and omly assigned to two groups . In the MP group ( n = 55 ) , procedures were performed using an endodontic irrigating syringe ( Max-i-Probe ; Dentsply Rinn , Elgin , IL ) . The EV group ( n = 55 ) used an irrigation device based on negative apical pressure ( EndoVac ; Discus Dental , Culver City , CA ) . Postoperatively , the patients were prescribed ibuprofen 200 mg to take every 8 hours if required . Pain levels were assessed by an analog scale question naire after 4 , 24 , and 48 hours . The amount of ibuprofen taken was recorded at the same time intervals . RESULTS During the 0- to 4- , 4- to 24- , and 24- to 48-hour intervals after treatment , the pain experience with the negative apical pressure device was significantly lower than when using the needle irrigation ( p hours , the intake of analgesics was significantly lower in the group treated by the negative apical pressure device ( p pain intensity and the amount of analgesics . CONCLUSION The outcome of this investigation indicates that the use of a negative apical pressure irrigation device can result in a significant reduction of postoperative pain levels in comparison to conventional needle irrigation",
"INTRODUCTION Oval-shaped root canals might represent a great challenge for proper disinfection . This study compared the capability of a newly developed instrument , the self-adjusting file ( SAF ) , and rotary nickel-titanium ( NiTi ) instrumentation to eliminate Enterococcus faecalis population s from long oval root canals of extracted human teeth . As a secondary purpose , the ability of a modification in sampling technique to recover bacteria lodged in recesses of oval canals was evaluated . METHODS Long oval canals from m and ibular incisors and maxillary second premolars were infected with E. faecalis ( ATCC 29212 ) for 30 days and then r and omly distributed into 2 experimental groups . In group 1 , canals were prepared up to a 40/04 rotary BioRaCe instrument by using irrigation with NaviTip needles ; in group 2 , canals were prepared by using the SAF system with continuous irrigation . NaOCl and ethylenediaminetetraacetic acid were used as irrigants . Bacteriologic sample s were taken before ( S1 ) and after preparation ( S2a and S2b ) . RESULTS Reduction in the bacterial population s was highly significant in both groups ( P Preparation of long oval canals with the SAF was significantly more effective than rotary NiTi instrumentation in reducing intracanal E. faecalis counts ( P = .01 ) . Frequency of positive cultures in S2 sample s was 11 of 20 ( 55 % ) for rotary instrumentation and 4 of 20 ( 20 % ) for SAF instrumentation ( P = .048 ) . S2b sample s ( modified method ) yielded more positive sample s than S2a ( 12/40 vs 5/40 ) , but this difference reached no statistical significance ( P > .05 ) . CONCLUSIONS The SAF system was significantly more effective than rotary NiTi instrumentation used with syringe/needle irrigation in disinfecting long oval root canals in vitro . A modified sampling technique might be necessary for oval canals",
"This in vivo , prospect i ve , r and omized , single-blinded study histologically compared biofilm/necrotic debridement efficiency of a h and /rotary technique versus a h and /rotary/1 min ultrasound technique in the mesial roots of necrotic , human m and ibular molars . The h and /rotary group consisted of 20 mesial roots . The h and /rotary/ultrasound group consisted of 20 mesial roots prepared with the same h and /rotary technique followed by 1 min of ultrasonic irrigation , per canal , utilizing an ultrasonic needle in a MiniEndo unit . Following extraction , histologic preparation and staining , 0.2 mum cross-sections from the 1- to 3-mm apical levels were evaluated for percentage of biofilm/necrotic debris removal . Cleanliness results at the 1- , 2- and 3-mm levels for the h and /rotary and h and /rotary/ultrasound techniques , respectively , were : Canals , 80 % versus 95 % , 92 % versus 99 % , and 95 % versus 100 % ; Isthmuses , 33 % versus 83 % , 31 % versus 86 % , 45 % versus 91 % . Statistical analysis revealed mean percent canal and isthmus cleanliness values to be significantly higher for h and /rotary/ultrasound technique at all levels evaluated",
"This study is to investigate the efficacy of different irrigant activation techniques on removal of accumulated hard tissue debris ( AHTD ) in mesial roots of human m and ibular molars . Extracted human m and ibular molars with an isthmus between the mesial root canals were selected based on micro-CT ( μCT ) scans . The mesial canals were instrumented to an apical diameter ISO30 using ProTaper rotary files . Teeth were r and omly assigned to three irrigant activation groups ( n = 10 ) : ultrasonically activated irrigation ( UAI ) using a size 20 Irrisafe for 3 × 20 s , laser-activated irrigation ( LAI ) with an Er : YAG laser ( 2940 nm ) and plain 300 μm fiber tip inside the canal ( 20 mJ , 20 Hz , 3 × 20 s ) , and laser-activated irrigation with identical parameters with a 400 μm photon-induced photoacoustic streaming ( PIPS ) tip held at the canal entrance . All teeth were scanned with μCT before and after instrumentation and after irrigant activation . After reconstruction and image processing , the canal system volume filled with hard tissue debris before and after irrigant activation was calculated . Changes in hard tissue debris volumes were compared between groups using one-way ANOVA . The percentage volume of hard tissue debris ( vol% ) was significantly lower after irrigant activation in all groups . Although the lowest debris values were observed in the laser groups , no significant differences in the vol% of accumulated hard tissue debris after activation were observed between groups . Accumulated hard tissue debris was reduced significantly in all activation groups . Ultrasonically and laser-activated irrigation regimens performed similarly in this respect . None of the tested methods was able to render the root canal systems free of debris",
"INTRODUCTION Studies using conventional endodontic protocol s show insufficient cleaning of root canal systems , often result ing in persistent infection and treatment failure . The GentleWave System ( GWS ; Sonendo , Inc , Laguna Hills , CA ) has been shown to result in a higher tissue dissolution rate in a study using bovine muscle . The purpose of this study was to compare the debridement efficacy of the GWS with a traditional method for cleaning root canals . METHODS Forty-five freshly extracted molars were r and omly separated into 3 treatment groups ( n = 15/group ) : group 1 , no treatment ; group 2 , conventional rotary instrumentation and needle irrigation ; and group 3 , minimal instrumentation and the GWS treatment . Roots were prepared per st and ard histologic tissue processing after hematoxylin-eosin staining ; sections were microscopically examined , and the percentage of soft tissue and debris remaining within the canals was morphometrically calculated . Images of the apical and middle regions of the roots were blindly analyzed . RESULTS Significant differences ( Welch 's t test ) were found between groups 2 and 3 in both apical ( P = .0015 ) and middle ( P = .0179 ) regions of the mesial roots of m and ibular molars and mesiobuccal roots of maxillary molars . Groups 2 and 3 result ed in cleaning 67.8 % and 97.2 % of the mesiobuccal and mesiolingual root canals of m and ibular molars and the mesiobuccal canals of maxillary molars , respectively , whereas the results were similar among groups 2 and 3 in the apical and middle regions of distal roots . Groups 2 and 3 revealed significantly less debris than group 1 ( P cleaning capacity and reduction in residual debris within the mesiobuccal and mesiolingual canals of m and ibular molars and the mesiobuccal canals of maxillary molars than those cleaned conventionally",
"Ninety-four single-canal roots were prepared using the step-down technique . Forty-two canals were irrigated with 2 % chlorhexidine , 42 canals with 5.25 % sodium hypochlorite ( NaOCl ) , and 10 control canals with phosphate-buffered saline ( PBS ) . The chlorhexidine and NaOCl groups were each then equally divided into a final irrigation group and a 1-min passive ultrasonic irrigation group . Canals were enlarged with a Parapost drill . The apical 3 - 5 mm was covered with nail polish . Canals were rinsed with PBS , dried , refilled with PBS , and stored . At 6 h , 20 microl of fluid was pipetted from each canal and placed into wells on agar plates , which were inoculated with Streptococcus sanguinis . The plates were incubated , and zones of inhibition were measured . Sampling was repeated at 24 , 48 , 72 , 96 , 120 , 144 , and 168 h. Residual antimicrobial activity with 2 % chlorhexidine was statistically significantly superior to 5.25 % NaOCl with irrigation alone and with final passive ultrasonic activation ( p Chlorhexidine experimental groups demonstrated residual antimicrobial activity for as long as 168",
"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",
"The purpose of this study was to evaluate and compare the postoperative level of pain after activation of irrigants using EndoActivator with conventional needle irrigation during root canal therapy . In this prospect i ve r and omised clinical trial , 72 symptomatic irreversible pulpitis patients were selected . Based on block r and omisation after routine root canal preparation , patients were assigned to two groups . In group EN , procedures were performed with endodontic irrigating needle ( n = 36 ) while group EA received activation using EndoActivator ( n = 36 ) in the final irrigation protocol . All the participants were called through phone at 8 , 24 and 48 h to analyse pain score using visual analogue scale . Those patients who developed pain were prescribed ibuprofen 200 mg . Pain score and frequency of tablet intake were recorded and statistically analysed . Results showed that group EA result ed in significantly less postoperative pain and analgesics intake than group EN . In conclusion , within the limitations of this study , the activation of irrigants using EndoActivator can be considered an effective method for reducing postoperative pain",
"The study involved 300 elderly patients with chronic periapical periodontitis . The patients were r and omly assigned into three groups . The treatment for group A used a Mtwo Ni-Ti rotary instrument combined with ultrasonic irrigation of a 2.5 % NaOCl solution . The group B used the same instrument combined with ultrasonic irrigation of an active silver ion antibacterial solution . The group C used the same instrument combined with syringe irrigation of a 2.5 % NaOCl solution . The root canal fillings were performed immediately after canal preparation . Twenty-four hours after the procedure , patients self-assessed pain levels according to the VAS table . The three groups returned after seven days so their postoperative acute reactions could be evaluated clinical ly . After six and twelve months , efficacy was evaluated . The self-assessed pain levels for group A and B were significantly lower than group C. The incidence of postoperative acute reactions after seven days for group A and B were significantly lower than those of group C. The effective rates after six and twelve months did not differ among these groups . The single-visit root canal treatment with a nickel-titanium rotary instrument combined with ultrasonic irrigation for elderly patients with chronic periapical periodontitis achieved short and long term efficacy and stability",
"INTRODUCTION Root canal irrigation carries a risk of extrusion of irrigant into the periapical tissues . The objective of this study was to compare different irrigation systems in matched pairs of teeth prepared to an apical size of 35.06 and 50.06 by measuring the frequency and extent of apical extrusion of sodium hypochlorite ( NaOCl ) into a simulated periapical environment . The None hypothesis was tested that there is no difference between systems . METHODS Bilaterally matched pairs ( n = 10 ) of single-canal extracted human anterior teeth were instrumented to an apical size of either 35.06 or 50.06 . Teeth were embedded in a gel containing the pH-sensitive dye M-cresol purple that changes from yellow at pH 7.4 to purple at pH 9 . Root canals were irrigated with 6 % NaOCl ( pH 11 ) by using EndoActivator ( EA ) , EndoVac ( EV ) , Rispi-Sonic/MicroMega 1500 ( MM ) , passive ultrasonic irrigation ( PUI ) , and syringe irrigation with a slot-tipped needle ( SN ) , so that each tooth underwent all irrigation procedures in a r and omized crossover design . Apical extrusion was evaluated by image analyses . RESULTS The frequency of extrusion was less in teeth with apical preparation size 35.06 ( 36 % ) compared with 50.06 ( 60 % ) ( P = .014 ) and was dependent on the irrigation system in 35.06 ( P = .039 ) but not 50.06 groups . In the 35.06 group the frequency of extrusion was less for EV than for MM and SN ( both P = .029 ) . The extent of extrusion was less for MM compared with PUI ( P = .024 ) and SN ( P = .046 ) in the 35.06 group and greater for SN compared with all other systems in the 50.06 group ( P frequency of apical extrusion of NaOCl was dependent on the type of root canal irrigation system and apical preparation size . The extent of extrusion depended on the irrigation system , with syringe and slotted-needle irrigation result ing in the greatest extent of extrusion",
"This study histologically compared the in vivo debridement efficacy of h and /rotary canal preparation versus a h and /rotary/ultrasound technique in mesial root canals of vital m and ibular molars . Group 1 consisted of 16 teeth prepared with a h and /rotary technique whereas group 2 consisted of 15 teeth prepared in similar fashion but followed by 1 min of ultrasonic irrigation , per canal , utilizing an ultrasonic needle in a MiniEndo unit . Five uninstrumented m and ibular molars served as histologic controls . After extraction and histologic preparation , 0.5 microm cross-sections , taken every 0.2 mm from the 1- to 3-mm apical levels , were evaluated for percentage of tissue removal . Nonparametric analysis revealed mean percent canal and isthmus cleanliness values to be significantly higher for group 2 at all levels evaluated , except one . In conclusion , the 1 min use of the ultrasonic needle after h and /rotary instrumentation result ed in significantly cleaner canals and isthmuses in the mesial roots of m and ibular molars",
"INTRODUCTION Recent in vitro studies that use an apical negative pressure irrigation system , EndoVac , have demonstrated promising results in the production of debris-free root canals , while also preventing potential extrusion of irrigants into the periapical region . We conducted a r and omized , controlled , prospect i ve clinical study to determine whether the use of EndoVac irrigation ( EndoVac group ) was more efficient compared with st and ard needle irrigation ( control group ) in obtaining canals from which microbes could not be cultivated . METHODS Routine endodontic therapy was performed in 48 patients with necrotic , single-rooted , single-canal teeth . The patients were r and omly assigned to either the EndoVac group ( n = 25 ) or control group ( n = 23 ) . Irrigation with either method was carried out with 0.5 % sodium hypochlorite . After surface disinfection , before instrumentation and on completion of chemomechanical preparation , intracanal microbial sample s were obtained and cultured under anaerobic conditions . The frequency of microbial cultivability by using either irrigation system was analyzed . RESULTS The frequency of obtaining culture-negative root canals was 90.9 % and 82.6 % for the control group and EndoVac group , respectively . There was no significant difference in the antimicrobial efficacy of either control group or EndoVac group ( Fisher exact test , P = .665 ) . Furthermore , no significant association between study variables and the irrigation systems ' antimicrobial efficacy was found ( P > .05 ) . CONCLUSIONS The results of this prospect i ve in vivo study demonstrate that the antimicrobial efficacy of EndoVac irrigation is comparable to that of st and ard irrigation",
"This study histologically compared the in vivo debridement efficacy of the step-back preparation versus a step-back/ultrasound preparation in the mesial root canals of vital m and ibular molars . Group 1 consisted of 17 teeth prepared with a step-back technique using intermittent irrigation with 5.25 % sodium hypochlorite . Group 2 consisted of 17 teeth prepared with a step-back technique as in group 1 followed by 3 min of ultrasonic instrumentation per canal utilizing a # 15 Endosonic file in an Enac unit set at 3.5 . An additional 6 ml/canal of 5.25 % sodium hypochlorite was used during the ultrasonic preparation . Eight uninstrumented m and ibular molars served as histological controls . Following extraction and histological preparation , 0.2-microns cross-sections from the 1- to 3-mm apical levels of the canal and isthmus were evaluated for percentage of tissue removal using an Olympus CUE-2 Image Analysis System . Factorial analysis of variance indicated canal and isthmus cleanliness values were significantly higher , at all 11 apical levels , with the ultrasonic technique . Sample values at the 1- , 2- , and 3-mm levels for the step-back and step-back/ultrasonic techniques , respectively , were : canal , 64 % versus 92 % , 81 % versus 97 % , and 90 % versus 99.9 % ; isthmus , 2 % versus 46 % , 15 % versus 60 % , and 16 % versus 83 %",
"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",
"The purpose of this prospect i ve , r and omized , single-blind study was to compare the in vivo antibacterial efficacy of a h and /rotary technique versus a h and /rotary/ultrasound technique in mesial root canals of necrotic m and ibular molars . The h and /rotary group consisted of 16 mesial roots prepared with a h and /rotary technique . The h and /rotary/ultrasound group consisted of 15 mesial roots prepared similarly , followed by 1 minute of ultrasonic irrigation per canal with an ultrasonic needle in a MiniEndo unit and 15 mL/canal of 6.0 % sodium hypochlorite . Canals were sample d before and after instrumentation and after 1 minute of ultrasonic irrigation . Sample s were incubated anaerobically on reduced blood agar for 7 days at 37 degrees C , and colony-forming units ( CFUs ) were counted . The addition of 1 minute of ultrasonic irrigation result ed in significant ( p = .0006 ) reduction in CFU count and positive cultures ( p = .0047 ) . Logistic regression analysis indicated the addition of ultrasonic irrigation was 7 times more likely to yield a negative culture",
"AIM To evaluate via a r and omized clinical trial the effect of continuous ultrasonic irrigation ( CUI ) on postoperative pain in m and ibular molars with nonvital pulps . METHODOLOGY Seventy m and ibular molars with nonvital pulps and apical periodontitis were treated endodontically using two different irrigation techniques . The patients were r and omly allocated to one of two groups , CUI ( n = 35 ) and syringe irrigation ( SI ) ( n = 35 ) . The CUI group received irrigant activation using a Proultra Piezoflow ultrasonic needle as the final irrigation protocol , whilst in the SI group , the final irrigation was performed using 27-gauge needle . All the patients were prescribed ibuprofen 400 mg to be taken every 8 h , if required . Postoperative pain using a visual analog scale and analgesic intake were recorded everyday for 7 days . Data were analysed using chi-Square , Mann-Whitney and multiple linear regression tests . RESULTS Mean postoperative pain was lower in the CUI as compared to SI group , but the difference was significant on the first day only ( P = 0.032 ) . The overall 24-h pain prevalence was 41.4 % . CUI had a lower incidence of pain ( 31.4 % ) as compared to the SI group ( 51.4 % ) , but the difference was not significant ( P > 0.05 ) . No significant difference was observed in analgesic consumption between the groups ( P > 0.05 ) . Regression analysis revealed a significant association of mean postoperative pain at 24 h with the irrigant protocol ( P = 0.017 ) and preoperative pain ( P = 0.000 ) . CONCLUSION A significant difference was observed between CUI and syringe irrigation on the first postoperative day following chemo-mechanical preparation . However , the benefit observed was not clinical ly relevant",
"OBJECTIVE Recent studies have shown that the apical negative-pressure irrigation system EndoVac ( Discus Dental ) produces better disinfection and cleanliness at the apical third of root canals than current irrigation methods using positive pressure . The aim of this histologic study was to compare the EndoVac system at two different exposure times to the traditional positive-pressure irrigation technique for root canal cleaning efficacy and to measure the volume of irrigation at the apical third . METHOD AND MATERIAL S Fifty extracted human incisors , canines , and premolars ( with one canal ) were used . All teeth were stored in sterile saline and then r and omly assigned to one of three experimental groups of 15 each . All teeth were cleaned and shaped at working length using Profile Series 29 ( Dentsply Tulsa ) to a size 6 ( ISO size 36 ) or larger depending on the first instrument to bind at the apical third . After working length was reached with the master apical file , apical irrigation was accomplished with 6 % sodium hypochlorite ( NaOCl ) over a predetermined time for each group as follows : group 1 , EndoVac for 210 seconds ; group 2 , EndoVac for 150 seconds ; group 3 , traditional positive-pressure irrigation for 210 seconds . The amount of debris left in the canals was quantified at 1 and 3 mm from working length . RESULTS No statistical differences were found at 3 mm from working length . At 1 mm from working length , an overall test of association was significant when comparing across the three groups ( P = .03 ) . CONCLUSION The apical negative-pressure irrigation system EndoVac has the potential to achieve significantly better root canal cleaning at the apical third of root canals and in less exposure time than required with traditional positive-pressure irrigation",
"Introduction : This study compared the effect of conventional needle irrigation ( positive pressure ) and the EndoVac system ( Discus Dental , Culver City , CA ) ( negative pressure ) on postoperative pain in m and ibular molar teeth with symptomatic irreversible pulpitis . Methods : One hundred sixteen patients with symptomatic irreversible pulpitis were selected . Teeth were r and omly assigned to 2 groups according to the irrigation methods performed during root canal preparation . In group 1 , root canal irrigation was performed using a syringe and a 31‐G side‐port needle ( NaviTip ; Ultradent , South Jordan , UT ) . In group 2 , the EndoVac system was used for irrigation . Teeth were then obturated with gutta‐percha and a resin‐based sealer using the cold lateral compaction technique . The presence of postoperative pain was assessed after 6 , 24 , 48 , and 72 hours and 1 week . Results : At 6‐ , 24‐ , and 48‐hour time intervals , group 1 patients reported more intense postoperative pain than patients in group 2 ( P .05 ) , and in both groups the intensity of postoperative pain decreased over time . Conclusions : Apical positive pressure irrigation caused greater postoperative pain after endodontic therapy of m and ibular molar teeth with symptomatic irreversible pulpitis compared with the apical negative pressure irrigation system",
"Introduction This study compared the effect of several final irrigation agitation techniques ( sonic agitation , passive ultrasonic irrigation , and manual dynamic agitation [ MDA ] ) in comparison with needle irrigation on postoperative pain in m and ibular molar teeth with symptomatic irreversible pulpitis . Methods One hundred sixty‐eight patients with a single tooth diagnosed as symptomatic irreversible pulpitis were selected . Teeth were r and omly assigned to 4 groups based on the final irrigation methods . In group 1 ( needle irrigation ) , irrigation was conducted without agitation with a side‐port needle ; in group 2 , sonic agitation was used ; in group 3 , passive ultrasonic irrigation was used ; and in group 4 , MDA was used . Teeth were then obturated with gutta‐percha and a resin‐based sealer using the cold lateral compaction technique . The presence of postoperative pain was assessed after 6 , 24 , 48 , and 72 hours and 1 week . Results At the 6‐ and 24‐hour time intervals , group 4 patients reported more intense postoperative pain than those patients in groups 1 , 2 , and 3 ( P .05 ) , and in all groups the intensity of postoperative pain decreased over time . Conclusions MDA caused greater postoperative pain after endodontic therapy in m and ibular molar teeth with symptomatic irreversible pulpitis compared with the other methods in the first 24 hours",
"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"
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4117424a-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES To review the clinical outcomes of combined diet and physical activity interventions for population s at high risk of type 2 diabetes . DESIGN Overview of systematic review s ( search date s April-December 2015 ) . SETTING Any level of care ; no geographical restriction . PARTICIPANTS Adults at high risk of diabetes ( as per measures of glycaemia , risk assessment or presence of risk factors ) . INTERVENTIONS Combined diet and physical activity interventions including ≥2 interactions with a healthcare professional , and ≥12 months follow-up . OUTCOME MEASURES Primary : glycaemia , diabetes incidence . Secondary : behaviour change , measures of adiposity , vascular disease and mortality . RESULTS 19 recent review s were identified for inclusion ; 5 with AMSTAR scores Most considered only r and omised controlled trials ( RCTs ) , and RCTs were the major data source in the remainder . Five trials were included in most review s. Almost all analyses reported that interventions were associated with net reductions in diabetes incidence , measures of glycaemia and adiposity , at follow-up duration s of up to 23 years ( typically Behaviour change , vascular disease and mortality outcome data were infrequently reported , and evidence of the impact of intervention on these outcomes was minimal . Evidence for age effect was mixed , and sex and ethnicity effect were little considered . CONCLUSIONS Relatively long- duration lifestyle interventions can limit or delay progression to diabetes under trial conditions . However , outcomes from more time-limited interventions , and those applied in routine clinical setting s , appear more variable , in keeping with the findings of recent pragmatic trials . There is little evidence of intervention impact on vascular outcomes or mortality end points in any context . ' Real-world ' implementation of lifestyle interventions for diabetes prevention may be expected to lead to modest outcomes
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"The YMCA ’s Diabetes Prevention Program gives you the skills you need and the support you deserve to make lasting healthy lifestyle changes . WHAT IS PREDIABETES ? Prediabetes occurs when blood sugar levels are higher than normal but not high enough for a type 2 diabetes diagnosis . Risk for developing type 2 diabetes may be reduced or eliminated by weight loss , healthier eating and increased physical activity",
"OBJECTIVE The Diabetes Prevention Program ( DPP ) demonstrated that weight loss from intensive lifestyle intervention ( ILI ) in adults with prediabetes could decrease progression to type 2 diabetes . Inner-city , low-income Hispanic women are at high risk for developing type 2 diabetes ; however , this type of intervention is not well established in this group . We hypothesized that a DPP intervention modified for a community health center ( CHC ) setting would decrease weight and improve metabolic measures in Hispanic women with prediabetes . RESEARCH DESIGN AND METHODS Women diagnosed with prediabetes on a screening oral glucose tolerance test were recruited from a CHC . Participants ( 90 % of whom were Hispanic ) were r and omized to either usual care ( age 43 ± 9.7 years , BMI 35.2 ± 7.3 kg/m2 ) or ILI ( age 43.8 ± 10.8 years , BMI 35.4 ± 8.5 kg/m2 ) , structured as 14 weeks of group sessions focused on food choices , behavior change , physical activity , and weight loss . One year after enrollment , 122 women repeated baseline measures . RESULTS Groups had similar baseline weight , BMI , and fasting and 2-h glucose . One year later , the ILI group had lost 3.8 kg ( 4.4 % ) , while the usual care group had gained 1.4 kg ( 1.6 % , P decreased 15 mg/dL ( 0.85 mmol/L ) in the ILI and 1 mg/dL ( 0.07 mmol/L ) in the usual care group ( P = 0.03 ) . Significant decreases favoring the ILI group were noted in BMI , percent body fat , waist circumference , and fasting insulin . CONCLUSIONS A 14-week ILI program based on the DPP can effectively be translated into a predominantly Hispanic CHC setting , result ing in decreased weight , improved fasting insulin , and smaller glucose excursions 1 year after enrolling in the program",
"BACKGROUND In the 2.8 years of the Diabetes Prevention Program ( DPP ) r and omised clinical trial , diabetes incidence in high-risk adults was reduced by 58 % with intensive lifestyle intervention and by 31 % with metformin , compared with placebo . We investigated the persistence of these effects in the long term . METHODS All active DPP participants were eligible for continued follow-up . 2766 of 3150 ( 88 % ) enrolled for a median additional follow-up of 5.7 years ( IQR 5.5 - 5.8 ) . 910 participants were from the lifestyle , 924 from the metformin , and 932 were from the original placebo groups . On the basis of the benefits from the intensive lifestyle intervention in the DPP , all three groups were offered group-implemented lifestyle intervention . Metformin treatment was continued in the original metformin group ( 850 mg twice daily as tolerated ) , with participants unmasked to assignment , and the original lifestyle intervention group was offered additional lifestyle support . The primary outcome was development of diabetes according to American Diabetes Association criteria . Analysis was by intention-to-treat . This study is registered with Clinical Trials.gov , number NCT00038727 . FINDINGS During the 10.0-year ( IQR 9.0 - 10.5 ) follow-up since r and omisation to DPP , the original lifestyle group lost , then partly regained weight . The modest weight loss with metformin was maintained . Diabetes incidence rates during the DPP were 4.8 cases per 100 person-years ( 95 % CI 4.1 - 5.7 ) in the intensive lifestyle intervention group , 7.8 ( 6.8 - 8.8 ) in the metformin group , and 11.0 ( 9.8 - 12.3 ) in the placebo group . Diabetes incidence rates in this follow-up study were similar between treatment groups : 5.9 per 100 person-years ( 5.1 - 6.8 ) for lifestyle , 4.9 ( 4.2 - 5.7 ) for metformin , and 5.6 ( 4.8 - 6.5 ) for placebo . Diabetes incidence in the 10 years since DPP r and omisation was reduced by 34 % ( 24 - 42 ) in the lifestyle group and 18 % ( 7 - 28 ) in the metformin group compared with placebo . INTERPRETATION During follow-up after DPP , incidences in the former placebo and metformin groups fell to equal those in the former lifestyle group , but the cumulative incidence of diabetes remained lowest in the lifestyle group . Prevention or delay of diabetes with lifestyle intervention or metformin can persist for at least 10 years . FUNDING National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK )",
"Background The Finnish Diabetes Prevention Study ( DPS ) was a r and omized controlled trial , which showed that it is possible to prevent type 2 diabetes by lifestyle changes . The aim of the present study was to examine whether the lifestyle intervention had an effect on the ten-year mortality and cardiovascular morbidity in the DPS participants originally r and omized either into an intervention or control group . Furthermore , we compared these results with a population -based cohort comprising individuals of varying glucose tolerance states . Methods and Findings Middle-aged , overweight people with IGT ( n = 522 ) were r and omized into intensive intervention ( including physical activity , weight reduction and dietary counseling ) , or control “ mini-intervention ” group . Median length of the intervention period was 4 years and the mean follow-up was 10.6 years . The population -based reference study cohort included 1881 individuals ( 1570 with normal glucose tolerance , 183 with IGT , 59 with screen-detected type 2 diabetes , 69 with previously known type 2 diabetes ) with the mean follow-up of 13.8 years . Mortality and cardiovascular morbidity data were collected from the national Hospital Discharge Register and Causes of Death Register . Among the DPS participants who consented for register linkage ( n = 505 ) , total mortality ( 2.2 vs. 3.8 per 1000 person years , hazard ratio HR = 0.57 , 95 % CI 0.21–1.58 ) and cardiovascular morbidity ( 22.9 vs. 22.0 per 1000 person years , HR = 1.04 , 95 % CI 0.72–1.51 ) did not differ significantly between the intervention and control groups . Compared with the population -based cohort with impaired glucose tolerance , adjusted HRs were 0.21 ( 95 % CI 0.09–0.52 ) and 0.39 ( 95 % CI 0.20–0.79 ) for total mortality , and 0.89 ( 95 % CI 0.62–1.27 ) and 0.87 ( 0.60–1.27 ) for cardiovascular morbidity in the intervention and control groups of the DPS , respectively . The risk of death in DPS combined cohort was markedly lower than in FINRISK IGT cohort ( adjusted HR 0.30 , 95 % CI 0.17–0.54 ) , but there was no significant difference in the risk of CVD ( adjusted HR 0.88 , 95 % CI 0.64–1.21 ) . Conclusions Lifestyle intervention among persons with IGT did not decrease cardiovascular morbidity during the first 10 years of follow-up . However , the statistical power may not be sufficient to detect small differences between the intervention and control groups . Low total mortality among participants of the DPS compared with individuals with IGT in the general population could be ascribed to a lower cardiovascular risk profile at baseline and regular follow-up . Trial Registration Clinical Trials.gov",
"Aims /hypothesisLifestyle modification helps in the primary prevention of diabetes in multiethnic American , Finnish and Chinese population s. In a prospect i ve community-based study , we tested whether the progression to diabetes could be influenced by interventions in native Asian Indians with IGT who were younger , leaner and more insulin resistant than the above population s. Methods We r and omised 531 ( 421 men 110 women ) subjects with IGT ( mean age 45.9±5.7 years , BMI 25.8±3.5 kg/m2 ) into four groups . Group 1 was the control , Group 2 was given advice on lifestyle modification ( LSM ) , Group 3 was treated with metformin ( MET ) and Group 4 was given LSM plus MET . The primary outcome measure was type 2 diabetes as diagnosed using World Health Organization criteria . Results The median follow-up period was 30 months , and the 3-year cumulative incidences of diabetes were 55.0 % , 39.3 % , 40.5 % and 39.5 % in Groups 1–4 , respectively . The relative risk reduction was 28.5 % with LSM ( 95 % CI 20.5–37.3 , p=0.018 ) , 26.4 % with MET ( 95 % CI 19.1–35.1 , p=0.029 ) and 28.2 % with LSM + MET ( 95 % CI 20.3–37.0 , p=0.022 ) , as compared with the control group . The number needed to treat to prevent one incident case of diabetes was 6.4 for LSM , 6.9 for MET and 6.5 for LSM + MET . Conclusions /interpretationProgression of IGT to diabetes is high in native Asian Indians . Both LSM and MET significantly reduced the incidence of diabetes in Asian Indians with IGT ; there was no added benefit from combining them",
"Aims : To compare data on cardiovascular risk factor changes in lipids , insulin , proinsulin , fibrinolysis , leptin and C-reactive protein , and on diabetes incidence , in relation to changes in lifestyle . Methods : The study was a r and omized lifestyle intervention trial conducted in northern Sweden between 1995 and 2000 , in 168 individuals with impaired glucose tolerance ( IGT ) and body mass index above 27 at start . The intensive intervention group ( n = 83 ) was subjected to a 1-month residential lifestyle programme . The usual care group ( n = 85 ) participated in a health examination ending with a single counselling session . Follow-up was conducted at 1 , 3 and 5 years . Results : At 1-year follow-up , an extensive cardio-metabolic risk factor reduction was demonstrated in the intensive intervention group , along with a 70 % decrease of progress to type 2 diabetes . At 5-year follow-up , most of these beneficial effects had disappeared . Reported physical activity and fibre intake as well as high-density lipoprotein cholesterol were still increased , and fasting insulin and proinsulin were lower . Conclusions : The intervention affected several important cardio-metabolic risk variables beneficially , and reduced the risk for type 2 diabetes , but the effects persisted only as long as the new lifestyle was maintained . Increased physical activity seemed to be the behaviour that was most easy to preserve",
"OBJECTIVES Prevention of type 2 diabetes ( T2DM ) is a priority in healthcare , but there is a lack of evidence investigating how to effectively translate prevention research into a UK primary care setting . We assessed whether a structured education programme targeting lifestyle and behaviour change was effective at preventing progression to T2DM in people with pre-diabetes . MATERIAL S AND METHODS Forty-four general practice s were r and omised to receive either st and ard care or a 6hour group structured education programme with an annual refresher course , and regular phone contact . Participants were followed up for 3years . The primary outcome was progression to T2DM . RESULTS Eight hundred and eighty participants were included ( 36 % female , mean age 64years , 16 % ethnic minority group ) ; 131 participants developed T2DM . There was a non-significant 26 % reduced risk of developing T2DM in the intervention arm compared to st and ard care ( HR 0.74 , 95 % CI 0.48 , 1.14 , p=0.18 ) . The reduction in T2DM risk when excluding those who did not attend the initial education session was also non-significant ( HR 0.65 , 0.41 , 1.03 , p=0.07 ) . There were statistically significant improvements in HbA1c ( -0.06 , -0.11 , -0.01 ) , LDL cholesterol ( -0.08 , -0.15 , -0.01 ) , sedentary time ( -26.29 , -45.26 , -7.32 ) and step count ( 498.15 , 162.10 , 834.20 ) when data were analysed across all time points . CONCLUSIONS This study suggests that a relatively low re source , pragmatic diabetes prevention programme result ed in modest benefits to biomedical , lifestyle and psychosocial outcomes , however the reduction to the risk of T2DM did not reach significance . The findings have important implication s for future research and primary care",
"Background / Objectives : To evaluate the effect of a 4.1-year ( range 3–6 years ) lifestyle intervention according to general public health recommendations on glucose tolerance and dropout in a Dutch population with impaired glucose tolerance (IGT).Subjects/ Methods : In the Study on Lifestyle intervention and Impaired glucose tolerance Maastricht , 147 Caucasian IGT subjects were r and omized to an intervention group ( INT : n=74 ; 38 male , 36 female ) and control group ( CON : n=73 ; 37 male , 36 female ) . Annually , subjects underwent measurements of body weight , anthropometry , glucose tolerance ( oral glucose tolerance test ) , insulin resistance ( homeostasis model assessment -insulin resistance ) , maximal aerobic capacity ( VO2 max ) , blood lipids and blood pressure . INT received individual advice regarding a healthy diet and physical activity . Results : INT decreased their saturated fat intake , increased their carbohydrate intake ( P and VO2 max ( P=0.04 ) compared with CON . Body weight did not change significantly ( P=0.20 ) between the groups . After an initial decrease , 2-h glucose levels overall increased in INT ( + 0.11 mmol/l ) , but significantly less than CON ( + 1.18 mmol/l ; P=0.04 ) . Diabetes incidence was lower in INT versus CON ( 30 versus 56 % , P=0.04 ) . Change in body weight was associated with change in 2-h glucose levels ( β=0.399 mmol/l per kg , P=0.02 ) . Dropouts had a lower aerobic fitness and socioeconomic status , and a higher body mass index ( BMI ) and 2-h glucose compared with non-dropouts . Conclusions : Prolonged feasible changes in diet and physical activity prevent deterioration of glucose tolerance and reduce diabetes risk . Low socioeconomic status , low aerobic fitness and high BMI and 2-h glucose are indicative of dropout to the program",
"AIM To evaluate the effectiveness of lifestyle interventions in people with impaired glucose tolerance ( IGT ) . METHODS Participants with IGT ( n=78 ) , diagnosed on two consecutive oral glucose tolerance tests ( OGTTs ) , were r and omly assigned to a 2-year lifestyle intervention or to a control group . Main outcome measures were changes from baseline in : nutrient intake ; physical activity ; anthropometry , glucose tolerance and insulin sensitivity . Measurements were repeated at 6 , 12 and 24 months follow-up . RESULTS After 24 months follow-up , there was a significant fall in total fat consumption ( difference in change between groups ( Delta intervention-Delta control)= -17.9 , 95 % confidence interval ( CI ) -33.6 to -2.1g/day ) as a result of the intervention . Body mass was significantly lower in the intervention group compared with controls after 6 months ( -1.6 , 95 % CI -2.9 to -0.4 kg ) and 24 months ( -3.3 , 95 % CI -5.7 to -0.89 kg ) . Whole body insulin sensitivity , assessed by the short insulin tolerance test ( ITT ) , improved after 12 months in the intervention group ( 0.52 , 95 % CI 0.15 - 0.89%/min ) . CONCLUSIONS These findings complement the findings of the Finnish Diabetes Prevention Study and the American Diabetes Prevention Study , both of which tested intensive interventions , by showing that pragmatic lifestyle interventions result in improvements in obesity and whole body insulin sensitivity in individuals with IGT , without change in other cardiovascular risk factors",
"BACKGROUND Lifestyle interventions among people with impaired glucose tolerance reduce the incidence of diabetes , but their effect on all-cause and cardiovascular disease mortality is unclear . We assessed the long-term effect of lifestyle intervention on long-term outcomes among adults with impaired glucose tolerance who participated in the Da Qing Diabetes Prevention Study . METHODS The study was a cluster r and omised trial in which 33 clinics in Da Qing , China-serving 577 adults with impaired glucose tolerance-were r and omised ( 1:1:1:1 ) to a control group or lifestyle intervention groups ( diet or exercise or both ) . Patients were enrolled in 1986 and the intervention phase lasted for 6 years . In 2009 , we followed up participants to assess the primary outcomes of cardiovascular mortality , all-cause mortality , and incidence of diabetes in the intention-to-treat population . FINDINGS Of the 577 patients , 439 were assigned to the intervention group and 138 were assigned to the control group ( one refused baseline examination ) . 542 ( 94 % ) of 576 participants had complete data for mortality and 568 ( 99 % ) contributed data to the analysis . 174 participants died during the 23 years of follow-up ( 121 in the intervention group vs 53 in the control group ) . Cumulative incidence of cardiovascular disease mortality was 11.9 % ( 95 % CI 8.8 - 15.0 ) in the intervention group versus 19.6 % ( 12.9 - 26.3 ) in the control group ( hazard ratio [ HR ] 0.59 , 95 % CI 0.36 - 0.96 ; p=0.033 ) . All-cause mortality was 28.1 % ( 95 % CI 23.9 - 32.4 ) versus 38.4 % ( 30.3 - 46.5 ; HR 0.71 , 95 % CI 0.51 - 0.99 ; p=0.049 ) . Incidence of diabetes was 72.6 % ( 68.4 - 76.8 ) versus 89.9 % ( 84.9 - 94.9 ; HR 0.55 , 95 % CI 0.40 - 0.76 ; p=0.001 ) . INTERPRETATION A 6-year lifestyle intervention programme for Chinese people with impaired glucose tolerance can reduce incidence of cardiovascular and all-cause mortality and diabetes . These findings emphasise the long-term clinical benefits of lifestyle intervention for patients with impaired glucose tolerance and provide further justification for adoption of lifestyle interventions as public health measures to control the consequences of diabetes . FUNDING Centers for Disease Control and Prevention , WHO , the China-Japan Friendship Hospital , Da Qing First Hospital "
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41174286-06ff-11f0-808a-c43d1ab1c353
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Obese patients have an increased prevalence of cardiovascular ( CV ) risk factors , which improve with bariatric surgery , but whether bariatric surgery reduces long-term CV events remains ill defined . A systematic review of published research was conducted , and CV risk models were applied in a validation cohort previously published . A st and ardized MEDLINE search using terms associated with obesity , bariatric surgery , and CV risk factors identified 6 test studies . The validation cohort consisted of a population -based , historical cohort of 197 patients who underwent Roux-en-Y gastric bypass and 163 control patients , identified through the Rochester Epidemiology Project . Framingham and Prospect i ve Cardiovascular Munster Heart Study ( PROCAM ) risk scores were applied to calculate 10-year CV risk . In the validation cohort , absolute 10-year Framingham risk score for CV events was lower at follow-up in the bariatric surgery group ( 7.0 % to 3.5 % , p PROCAM risk in the bariatric surgery group decreased from 4.1 % to 2.0 % ( p CV risk , with estimated relative risk reductions for bariatric surgery patients ranging from 18 % to 79 % using the Framingham risk score compared with 8 % to 62 % using the PROCAM risk score . In conclusion , bariatric surgery predicts long-term decreases in CV risk in obese patients
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"Background : Morbid obesity requires life-long treatment , and bariatric surgery provides the best results . Among the bariatric procedures , laparoscopic Roux-en-Y gastric bypass ( LRYGBP ) has been considered to be superior . However , it requires advanced laparoscopic skills and a learning curve . We analyzed our results in an initial series of 100 patients . Methods : Data of 100 consecutive patients who underwent LRYGBP for morbid obesity in a 2.5-year period were prospect ively collected and analyzed with emphasis on results and complications . Results : Mean age was 31±5 years . There were 63 woman and 37 men . Preoperative BMI was 50±9 kg/m2 . 33 patients were considered super-obese ( BMI > 50 ) . Mean operative time was 3.8 ± 0.7 hours . Two patients required conversion to open surgery . Mean hospital stay was 6 days . Complications occurred in 10 patients . Mortality rate was 2 % . Excess body weight loss was as follows : 33 ± 8 % at 3 months ( n=92 ) , 47 ± 2 % at 6 months ( n=82 ) , 62 ± 4 % at 1 year ( n= 70 ) , 66 ± 5 % at 18 months ( n= 63 ) and 67 ± 8 % at 2 years ( n= 35 ) . There was significant improvement in several co-morbid conditions , such as diabetes and hypertension . Conclusion : LRYGBP is a reproducible technique . It requires the combination of bariatric and laparoscopic expertise",
"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",
"A definitive model for predicting absolute risk of coronary heart disease ( CHD ) in male and female people with Type II diabetes is not yet available . This paper provides an equation for estimating the risk of new CHD events in people with Type II diabetes , based on data from 4540 U.K. Prospect i ve Diabetes Study male and female patients . Unlike previously published risk equations , the model is diabetes-specific and incorporates glycaemia , systolic blood pressure and lipid levels as risk factors , in addition to age , sex , ethnic group , smoking status and time since diagnosis of diabetes . All variables included in the final model were statistically significant ( P CHD risk required by current guidelines for the primary prevention of CHD in Type II diabetes",
"Abstract Objective To establish the predictive accuracy of the Framingham risk score for coronary heart disease in a representative British population . Design Prospect i ve cohort study . Setting 24 towns in the United Kingdom . Participants 6643 British men aged 40 - 59 years and free from cardiovascular disease at entry into the British regional heart study . Main outcome measures Comparison of observed 10 year coronary heart disease mortality and event rates with predicted rates for each individual , using the relevant Framingham risk equation . Results Of 6643 men , 2.8 % ( 95 % confidence interval 2.4 % to 3.2 % ) died from coronary heart disease compared with 4.1 % predicted ( relative overestimation 47 % , P fatal or non-fatal coronary heart disease event occurred in 10.2 % ( 9.5 % to 10.9 % ) of the men compared with 16.0 % predicted ( relative overestimation 57 % , P deaths from coronary heart disease and non-fatal events occurred in the 93 % of men classified at low risk ( absolute coronary risk assigned to individuals in the United Kingdom",
"AIMS To assess whether the Framingham and PROCAM risk functions were applicable to men in Belfast and France . METHODS AND RESULTS We performed an external validation study within the PRIME ( Prospect i ve Epidemiological Study of Myocardial Infa rct ion ) cohort study . It comprised men recruited in Belfast ( 2399 ) and France ( 7359 ) who were aged 50 to 59 years , free of CHD at baseline ( 1991 to 1993 ) and followed over 5 years for CHD events ( coronary death , myocardial infa rct ion , angina pectoris ) . We compared the relative risks of CHD associated with the classic risk factors in PRIME with those in Framingham and PROCAM cohorts . We then compared the number of predicted and observed 5-year CHD events ( calibration ) . Finally , we estimated the ability of the risk functions to separate high risk from low risk subjects ( discrimination ) . The relative risk of CHD calculated for the various factors in the PRIME population were not statistically different from those published in the Framingham and PROCAM risk functions . The number of CHD events predicted by these risk functions however clearly overestimated those observed in Belfast and France . The two risk functions had a similar ability to separate high risk from low risk subjects in Belfast and France ( c-statistic range : 0.61 - 0.68 ) . CONCLUSION The Framingham and PROCAM risk functions should not be used to estimate the absolute CHD risk of middle-aged men in Belfast and France without any CHD history because of a clear overestimation . Specific population risk functions are needed",
"Cardiovascular morbidity , including coronary artery disease and left ventricular hypertrophy , and mortality are high in patients following renal transplantation . Cardiovascular disease is thought to be due to traditional ( hypertension , hyperlipidemia , diabetes mellitus and smoking ) as well as nontraditional cardiovascular risk factors ( microinflammation ) . Furthermore , immunosuppressive drugs , namely , calcineurin inhibitors , sirolimus , and steroids , have been reported to adversely affect cardiovascular risk factors ( e.g. , hypertension , hyperlipidemia , hyperglycemia ) . Evidence from comparative trials and from conversion studies suggest that blood pressure , hyperlipidemia , and hyperglycemia after renal transplantation may be differentially affected by the calcineurin inhibitors cyclosporine and tacrolimus . In the European Tacrolimus versus Cyclosporin A Microemulsion Renal Transplantation Study , 557 patients were r and omly allocated to therapy with tacrolimus ( n = 286 ) versus cyclosporine ( n = 271 ) . In addition , to blood pressure , serum cholesterol , HDL cholesterol , triglycerides , and blood glucose , we estimated the 10-year risk of coronary heart disease ( Framingham risk score ) . Tacrolimus result ed in a significantly lower time-weighted average of serum cholesterol ( P mean arterial blood pressure ( P blood glucose ( P cyclosporine . Mean 10-year coronary artery disease risk estimate was significantly lower in men treated with tacrolimus , ( 10.0 % versus 13.2 % ; P Tacrolimus and cyclosporine microemulsion have compound-specific effects on cardiovascular risk factors that differentially affect the predicted rate of coronary artery disease",
"Objective To examine the validity of estimates of coronary heart disease ( CHD ) risk by the Framingham risk function , for European population s. Design Comparison of CHD risk estimates for individuals derived from the Framingham , prospect i ve cardiovascular Münster ( PROCAM ) , Dundee , and British regional heart ( BRHS ) risk functions . Setting Sheffield Hypertension Clinic . Patients —206 consecutive hypertensive men aged 35–75 years without preexisting vascular disease . Results There was close agreement among the Framingham , PROCAM , and Dundee risk functions for average CHD risk . For individuals the best correlation was between Framingham and PROCAM , both of which use high density lipoprotein ( HDL ) cholesterol . When Framingham was used to target a CHD event rate > 3 % per year , it identified men with mean CHD risk by PROCAM of 4.6 % per year and all had CHD event risks > 1.5 % per year . Men at lower risk by Framingham had a mean CHD risk by PROCAM of 1.5 % per year , with 16 % having a CHD event risk > 3.0 % per year . BRHS risk function estimates of CHD risk were fourfold lower than those for the other three risk functions , but with moderate correlations , suggesting an important systematic error . Conclusion There is close agreement between the Framingham , PROCAM , and Dundee risk functions as regards average CHD risk , and moderate agreement for estimates within individuals . Taking PROCAM as the external st and ard , the Framingham function separates high and low CHD risk groups and is acceptably accurate for northern European population s , at least in men",
"BACKGROUND Obesity is associated with increased mortality . Weight loss improves cardiovascular risk factors , but no prospect i ve interventional studies have reported whether weight loss decreases overall mortality . In fact , many observational studies suggest that weight reduction is associated with increased mortality . METHODS The prospect i ve , controlled Swedish Obese Subjects study involved 4047 obese subjects . Of these subjects , 2010 underwent bariatric surgery ( surgery group ) and 2037 received conventional treatment ( matched control group ) . We report on overall mortality during an average of 10.9 years of follow-up . At the time of the analysis ( November 1 , 2005 ) , vital status was known for all but three subjects ( follow-up rate , 99.9 % ) . RESULTS The average weight change in control subjects was less than + /-2 % during the period of up to 15 years during which weights were recorded . Maximum weight losses in the surgical subgroups were observed after 1 to 2 years : gastric bypass , 32 % ; vertical-b and ed gastroplasty , 25 % ; and b and ing , 20 % . After 10 years , the weight losses from baseline were stabilized at 25 % , 16 % , and 14 % , respectively . There were 129 deaths in the control group and 101 deaths in the surgery group . The unadjusted overall hazard ratio was 0.76 in the surgery group ( P=0.04 ) , as compared with the control group , and the hazard ratio adjusted for sex , age , and risk factors was 0.71 ( P=0.01 ) . The most common causes of death were myocardial infa rct ion ( control group , 25 subjects ; surgery group , 13 subjects ) and cancer ( control group , 47 ; surgery group , 29 ) . CONCLUSIONS Bariatric surgery for severe obesity is associated with long-term weight loss and decreased overall mortality",
"Statistical analysis of difference between groups in change for some variable , adjusting for initial value , is complicated by the presence of intra-individual variation in that variable . We estimate here the asymptotic bias that results from calculating the adjusted between-group difference by ordinary least squares ( OLS ) from observed data . We also present explicit formulae that use the OLS estimates , the difference between treatment groups in mean initial values , and a measure of the intra-individual variation to compute a corrected estimator and its variance . Alternatively , we can use OLS on transformed data to obtain unbiased estimates , in which we replace initial observed values by conditional Stein estimates of true values . We illustrate the results with data from an observational study and a clinical trial",
"OBJECTIVE To analyze the short-term effects of weight loss on the cardiovascular risk factors in morbidly obese patients . RESEARCH METHODS AND PROCEDURES Five metabolic cardiovascular risk factors ( blood glucose , blood pressure , total cholesterol , high-density lipoprotein (HDL)-cholesterol , and triglycerides ) were determined before and 15.3 + /- 2.1 months after laparoscopic gastric b and ing in 650 morbidly obese patients . Global cardiovascular risk was calculated according to the Prospect i ve Cardiovascular Münster ( PROCAM ) scoring system . RESULTS Mean weight loss was 22.7 + /- 20.4 kg . Normalization of the metabolic alteration was observed in 67.3 % of patients with diabetes , 38.3 % of patients with hypercholesterolemia , 72.5 % of patients with low HDL-cholesterol , 72.3 % of patients with hypertriglyceridemia , and 46.7 % of patients with hypertension . PROCAM score fell from 31.4 + /- 11.6 to 28.0 + /- 12.0 points ( p total cholesterol and blood pressure were unrelated to percentage weight loss . Percentage weight loss was significantly related to the reductions of fasting blood glucose , triglyceride level , and the PROCAM score and to the increase of HDL-cholesterol concentrations observed after surgery . However , the strength of these four relationships was generally low . The variations of HDL-cholesterol concentrations and blood pressure levels were more influenced by actual energy balance than by the extent of weight loss . DISCUSSION Weight loss observed in the first 12 to 18 months after gastric b and ing was associated with a significant improvement of single cardiovascular risk factors and global risk . On the other h and , the extent of weight loss was poorly related to the magnitude of improvement in cardiovascular risk",
"BACKGROUND As severe obesity becomes an increasing problem , it is important that the role of surgery in the management of the condition becomes better understood and recognised . This study reports the outcome of a large series of gastric bypass operations performed for severe obesity by a single surgeon . METHODS AND RESULTS Between 1990 - 2002 , 310 patients underwent gastric bypass surgery with all data being collected prospect ively and recorded on a computerised data base . Mean preoperative weight and percentage excess weight were 132 kg and 119 % , respectively . There was no 30-day mortality and only one life threatening complication . Re-operations were required in 43 patients , most of which were related to ring removal or staple line disruption seen in the earlier form of gastric bypass . These problems are largely overcome with the currently performed technique . Percentage excess weight loss at 1 , 2 , 3 , 4 and 5 years was 73 % , 73 % , 66 % , 64 % , and 59 % respectively . Forty-nine of the 52 patients with type 2 diabetes were cured following surgery and 87 % of those with hypertension resolved or improved their condition . Dyslipidaemia resolved or improved in 87 % and asthma was cured or improved in 89 % of those affected . 61 patients had symptoms of obstructive sleep apnoea prior to surgery and in 51 of these symptoms resolved following surgery . CONCLUSION This study confirms that gastric bypass is a very effective treatment for severe obesity and can be performed with a high level of safety . Gastric transection is an important component of the operation . The majority of important comorbidities seen before surgery either resolve or improve following surgery . Bariatric surgery is establishing itself as a very important and satisfying branch of upper gastrointestinal ( GI ) surgery",
"Increased prevalence of cardiovascular risk factors has been acknowledged in liver transplant recipients , and an increased incidence of cardiovascular events has been suspected . Individual risk determination , however , has not yet been established . Outpatient charts of 438 primary liver transplants have been review ed , and suspected cardiovascular risk factors were correlated with cardiovascular events observed during a follow-up period of 10 yr . Receiver operation characteristics curve ( ROC ) analysis was performed to vali date established cardiovascular risk scores . For calibration , the Hosmer-Lemeshow test was performed . A total of 303 of 438 patients were available for risk factor analysis at 6 months and demonstrated complete follow-up data ( 175 male , 128 female ) . A total of 40 of those 303 patients experienced fatal or nonfatal cardiovascular events ( 13.2 % ) . In univariate analysis , age ( P body mass index ( P = 0.018 ) , cholesterol ( P = 0.044 ) , creatinine ( P = 0.006 ) , diabetes mellitus ( P = 0.017 ) , glucose ( 0.006 ) , and systolic blood pressure ( P = 0.043 ) , but not cyclosporine A ( P = 0.743 ) , tacrolimus ( P = 0.870 ) , or steroid medication ( P = 0.991 ) , were significantly associated with cardiovascular events . Multivariate analysis , however , identified only age , gender , and cholesterol as independent predictors . In ROC analysis , corresponding areas under the curve for Systematic Coronary Risk Evaluation Project ( SCORE ) , Prospect i ve Cardiovascular Münster Study ( PROCAM ) , and Framingham risk scores ( FRSs ) were calculated with 0.800 , 0.778 , and 0.707 , respectively . Calibration demonstrated an improved goodness of fit for PROCAM compared to SCORE risk calculations . In conclusion , SCORE and PROCAM proved to be valuable in discriminating our liver transplant recipients for their individual risk of cardiovascular events . Furthermore , calibrated PROCAM risk estimates are required to calculate the number of patients needed to treat in the setup of prospect i ve intervention trials"
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The effects of telemedicine strategies on the management of diabetes is not clear . This study aim ed to investigate the impact of different telemedicine strategies on glycaemic control management of type 2 diabetes patients . A search was performed in 6 data bases from inception until September 2016 for r and omized controlled studies that examined the use of telemedicine in adults with type 2 diabetes . Studies were independently extracted and classified according to the following telemedicine strategies : teleeducation , telemonitoring , telecase-management , telementoring and teleconsultation . Traditional and network meta- analysis were performed to estimate the relative treatment effects . A total of 107 studies involving 20,501 participants were included . Over a median of 6 months follow-up , telemedicine reduced haemoglobin A1c ( HbA1c ) by a mean of 0.43 % ( 95 % CI : −0.64 % to −0.21 % ) . Network meta- analysis showed that all telemedicine strategies were effective in reducing HbA1c significantly compared to usual care except for telecase-management and telementoring , with mean difference ranging from 0.37 % and 0.71 % . Ranking indicated that teleconsultation was the most effective telemedicine strategy , followed by telecase-management plus telemonitoring , and finally teleeducation plus telecase-management . The review indicates that most telemedicine strategies can be useful , either as an adjunct or to replace usual care , leading to clinical ly meaningful reduction in HbA1c
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"OBJECTIVE This study was design ed to evaluate the impact of a teleassistance system on the metabolic control of type 2 diabetes patients . RESEARCH DESIGN AND METHODS We conducted a 1-year controlled parallel-group trial comparing patients r and omized ( 1 ) to an intervention group , assigned to a teleassistance system using real-time transmission of blood glucose results , with immediate reply when necessary , and telephone consultations , or ( 2 ) to a control group , being regularly followed-up at their healthcare center . Study subjects were type 2 diabetes patients > 30 years of age followed in the primary care setting . RESULTS A total of 328 type 2 diabetes patients were recruited from 35 family practice s in the province of Málaga , Spain . There was a reduction in hemoglobin A1c after 12 months from 7.62 + /- 1.60 % to 7.40 + /- 1.43 % ( P = 0.027 ) in the intervention group and from 7.44 + /- 1.31 % to 7.35 + /- 1.38 % ( P = 0.303 ) in the control group . The difference in the change between groups was not statistically significant . There was also a significant decrease in systolic and diastolic blood pressure , total cholesterol , low-density lipoprotein cholesterol , and body mass index in the intervention group . In the control group , the only significant decline was in low-density lipoprotein cholesterol . CONCLUSIONS A teleassistance system using real-time transmission of blood glucose results with an option to make telephone consultations is feasible in the primary care setting as a support tool for family physicians in their follow-up of type 2 diabetes patients",
"Objective To evaluate the impacts of using SMS on improving laboratory test levels and Knowledge , Attitude , Practice ( KAP ) and Self Efficacy ( SE ) of patients with type 2 diabetes mellitus ( DM ) in Iran . Material s and methods In this r and omized controlled trial study , a total of 81 type 2 diabetes patients were r and omly assigned into two groups exp . group ( n = 43 ) and cont . group ( n = 38 ) . Only exp . group received 4 messages weekly consisted of diet , exercise , medication taking and . The research ers provided the intervention for 12 weeks . Data were collected with results of laboratory tests and KAP , SE reliable and valid question naires and demographic characteristics list . Data gathering at the baseline of the study and after 3 months intervention and was analyzed by SPSS11.5 software using descriptive and inferential statistics methods . Results The results of this study showed that exp . group compared with cont . group improved significantly in HbA1C ( p = 0.024 ) , LDL ( p = 0.019 ) , cholesterol ( p = 0.002 ) , BUN ( p ≤ 0.001 ) , micro albumin ( p ≤ 0.001 ) , knowledge ( p ≤ 0.001 ) , practice ( p ≤ 0.001 ) and self efficacy ( p ≤ 0.001 ) . Conclusion The finding of this study demonstrate the effectiveness of intervention using SMS via mobile phone in the management of type 2 diabetes mellitus ( DM ) . Thus , further studies are recommended for wide usage of distance education with mobile phone utilization",
"BACKGROUND Telehome care has been proposed as a solution to the challenges of providing effective and affordable care for patients with diabetes . METHODS A total of 100 adult patients with type 2 diabetes-divided between insulin and noninsulin requiring-was enrolled in a r and omized , controlled trial aim ed at investigating the effects of telehome monitoring . The experimental group ( n = 50 ) received an in-home wireless glucose monitor and transmitter , whereas the control group ( n = 50 ) was instructed to follow the conventional arrangement . RESULTS There was an overall reduction in HbA1c values in both experimental and control groups after 6 months . A significant difference in HbA1c values between the groups was observed only among the noninsulin-requiring patients ( decline from 6.95 % ± 0.82 % to 6.66 % ± 0.86 % in IB vs. 7.21 % ± 2.02 % to 7.2 % ± 1.86 % in IIB ; p = 0.02 ) . The experimental group reported considerably less hyperglycemic and hypoglycemic events . The profile of the patient who benefited the most from telemonitoring consisted of older , more educated patient who had acquired the disease relatively recently , and who spends most of the time at home . The experimental group had higher overall scores on quality of life measures and sense of control over diabetes . There was a positive association between educational attainment and ability to use the telemonitoring system without help ( p = 0.045 ) . CONCLUSIONS Although not conclusive because of the small sample and short observation period , the study suggests that telehome monitoring is an effective tool in controlling type 2 diabetes in a primary care setting",
"Background Type 2 diabetes mellitus is a worldwide challenge . Practice guidelines promote structured self-monitoring of blood glucose ( SMBG ) for informing health care providers about glycemic control and providing patient feedback to increase knowledge , self-efficacy , and behavior change . Paired glucose testing — pairs of glucose results obtained before and after a meal or physical activity — is a method of structured SMBG . However , frequent access to glucose data to interpret values and recommend actions is challenging . A complete feedback loop— data collection and interpretation combined with feedback to modify treatment — has been associated with improved outcomes , yet there remains limited integration of SMBG feedback in diabetes management . Incorporating telehealth remote monitoring and asynchronous electronic health record ( EHR ) feedback from certified diabetes educators (CDEs)—specialists in glucose pattern management — employ the complete feedback loop to improve outcomes . Objective The purpose of this study was to evaluate a telehealth remote monitoring intervention using paired glucose testing and asynchronous data analysis in adults with type 2 diabetes . The primary aim was change in glycated hemoglobin (A1c)—a measure of overall glucose management — between groups after 6 months . The secondary aims were change in self-reported Summary of Diabetes Self-Care Activities ( SDSCA ) , Diabetes Empowerment Scale , and Diabetes Knowledge Test . Methods A 2-group r and omized clinical trial was conducted comparing usual care to telehealth remote monitoring with paired glucose testing and asynchronous virtual visits . Participants were aged 30 - 70 years , not using insulin with A1c levels between 7.5 % and 10.9 % ( 58 - 96 mmol/mol ) . The telehealth remote monitoring tablet computer transmitted glucose data and facilitated a complete feedback loop to educate participants , analyze actionable glucose data , and provide feedback . Data from paired glucose testing were analyzed asynchronously using computer-assisted pattern analysis and were shared with patients via the EHR weekly . CDEs called participants monthly to discuss paired glucose testing trends and treatment changes . Separate mixed-effects models were used to analyze data . Results Participants ( N=90 ) were primarily white ( 64 % , 56/87 ) , mean age 58 ( SD 11 ) years , mean body mass index 34.1 ( SD 6.7 ) kg/m2 , with diabetes for mean 8.2 ( SD 5.4 ) years , and a mean A1c of 8.3 % ( SD 1.1 ; 67 mmol/mol ) . Both groups lowered A1c with an estimated average decrease of 0.70 percentage points in usual care group and 1.11 percentage points in the treatment group with a significant difference of 0.41 percentage points at 6 months ( SE 0.08 , t159=–2.87 , P=.005 ) . Change in medication ( SE 0.21 , t157=–3.37 , P=.009 ) was significantly associated with lower A1c level . The treatment group significantly improved on the SDSCA subscales carbohydrate spacing ( P=.04 ) , monitoring glucose ( P=.001 ) , and foot care ( P=.02 ) . Conclusions An eHealth model incorporating a complete feedback loop with telehealth remote monitoring and paired glucose testing with asynchronous data analysis significantly improved A1c levels compared to usual care . Trial Registration Clinical trials.gov NCT01715649 ; https://www . clinical trials.gov/ct2/show/NCT01715649 ( Archived by WebCite at http://www.webcitation.org/6ZinLl8D0 )",
"OBJECTIVE To assess the effects of web-based care management on glucose and blood pressure control over 12 months in patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS For this study , 104 patients with diabetes and HbA(1c ) ( A1C ) > or = 9.0 % who received their care at a Department of Veterans Affairs medical center were recruited . All participants completed a diabetes education class and were r and omized to continue with their usual care ( n = 52 ) or receive web-based care management ( n = 52 ) . The web-based group received a notebook computer , glucose and blood pressure monitoring devices , and access to a care management website . The website provided educational modules , accepted uploads from monitoring devices , and had an internal messaging system for patients to communicate with the care manager . RESULTS Participants receiving web-based care management had lower A1C over 12 months ( P care . Persistent website users had greater improvement in A1C when compared with intermittent users ( -1.9 vs. -1.2 % ; P = 0.051 ) or education and usual care ( -1.4 % ; P website data uploads was associated with a larger decline in A1C ( highest tertile -2.1 % , lowest tertile -1.0 % ; P Hypertensive participants in the web-based group had a greater reduction in systolic blood pressure ( P HDL cholesterol rose and triglycerides fell in the web-based group ( P Web-based care management may be a useful adjunct in the care of patients with poorly controlled diabetes",
"BACKGROUND Cardiovascular disease ( CVD ) and diabetes account for one-third of the mortality difference between African American and white patients . We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes . METHODS We r and omized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention . The 12-month intervention provided monthly self-management support and quarterly medication management facilitation . Co primary outcomes were changes in systolic blood pressure ( SBP ) , hemoglobin A1c ( HbA1c ) , and low-density lipoprotein cholesterol ( LDL-C ) over 12 months . We estimated between-intervention group differences over time using linear mixed-effects models . The secondary outcome was self-reported medication adherence . RESULTS The sample was 72 % female ; 49 % had low health literacy , and 37 % had annual income Model-based estimates for mean baseline SBP , HbA1c , and LDL-C were 136.8 mm Hg ( 95 % CI 135.0 - 138.6 ) , 8.0 % ( 95 % CI 7.8 - 8.2 ) , and 99.1 mg/dL ( 95 % CI 94.7 - 103.5 ) , respectively . Intervention patients received 9.9 ( SD 3.0 ) intervention calls on average . Primary providers replied to 76 % of nurse medication management facilitation contacts , 18 % of these result ed in medication changes . There were no between-group differences over time for SBP ( P = .11 ) , HbA1c ( P = .66 ) , or LDL-C ( P = .79 ) . Intervention patients were more likely than those receiving usual care to report improved medication adherence ( odds ratio 4.4 , 95 % CI 1.8 - 10.6 , P = .0008 ) , but adherent patients did not exhibit relative improvement in primary outcomes . CONCLUSIONS This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes . Further research is needed to determine how to maximally impact CVD risk factors in African American patients",
"Introduction Diabetes self-management education interventions in community gathering places have been moderately effective , but very few studies of intervention effectiveness have been conducted among African Americans with type 2 diabetes . This paper describes a church-based diabetes self-management education intervention for African Americans , a r and omized controlled trial to evaluate the intervention , and baseline characteristics of study participants . Methods A New DAWN : Diabetes Awareness & Wellness Network was conducted among 24 churches of varying size in North Carolina . Each church recruited congregants with type 2 diabetes and design ated a diabetes advisor , or peer counselor , to be part of the intervention team . Participants were enrolled at each church and r and omized as a unit to either the special intervention or the minimal intervention . The special intervention included one individual counseling visit , twelve group sessions , three postcard messages from the participant 's diabetes care provider , and twelve monthly telephone calls from a diabetes advisor . Baseline data included measures of weight , hemoglobin A1c , blood pressure , physical activity , dietary and diabetes self-care practice s , and psychosocial factors . The study to evaluate the intervention ( from enrollment visit to last follow-up ) began in February 2001 and ended in August 2003 . Results Twenty-four churches ( with 201 total participants ) were r and omized . Sixty-four percent of the participants were women . On average , the participants were aged 59 years and sedentary . They had an average of 12 years of education , had been diagnosed with diabetes for 9 years , had a body mass index of 35 , had a hemoglobin A1c level of 7.8 % , and had a reported dietary intake of 39 % of calories from fat . Conclusion A New DAWN is a culturally sensitive , church-based diabetes self-management education program for African Americans with type 2 diabetes that is being evaluated for effectiveness in a r and omized controlled trial . The outcomes of A New DAWN will contribute to the literature on community-based interventions for minority population s and help to inform the selection of approaches to improve diabetes care in this population",
"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",
"BACKGROUND Telemonitoring interventions featuring transmission of home glucose records to healthcare providers have result ed in improved glycemic control in patients with diabetes . No research has addressed the intensity or duration of telemonitoring required to sustain such improvements . PURPOSE The DiaTel study ( 10 January 2005 to 1 November 2007 ) compared active care management ( ACM ) with home telemonitoring ( n=73 ) to monthly care coordination ( CC ) telephone calls ( n=77 ) among veterans with diabetes and suboptimal glycemic control . The purpose of the DiaTel Extension was to assess whether initial improvements could be sustained with interventions of the same or lower intensity among participants who re-enrolled in a 6-month extension of DiaTel . METHODS DiaTel participants receiving ACM were re-assigned r and omly to monthly CC calls with continued telemonitoring but no active medication management ( ACM-to-CCHT , n=23 ) or monthly CC telephone calls ( ACM-to-CC , n=21 ) . DiaTel participants receiving CC were re-assigned r and omly to continued CC ( CC-to-CC , n=28 ) or usual care ( UC , ie , CC-to-UC , n=29 ) . Hemaglobin A1c ( HbA1c ) was assessed at 3 and 6 months following re-r and omization . RESULTS Marked HbA1c improvements observed in DiaTel ACM participants were sustained 6 months after re-r and omization in both ACM-to-CCHT and ACM-to-CC groups . Lesser HbA1c improvements observed in DiaTel CC participants were sustained in both CC-to-CC and CC-to-UC groups . No benefit was apparent for continued transmission of glucose data among DiaTel ACM participants or continued monthly telephone calls among DiaTel CC participants 6 months after re-r and omization . CONCLUSION Significant improvements in HbA1c achieved using home telemonitoring and active medication management for 6 months were sustained 6 months later with interventions of decreased intensity in VA Health System-qualified veterans . CLINICAL TRIAL REG . NO : NCT00245882 , http://www . clinical trials.gov",
"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 )",
"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",
"OBJECTIVE To improve quality and efficiency of care for elderly patients with type 2 diabetes , we introduced elderly-friendly strategies to the clinical decision support system (CDSS)-based ubiquitous healthcare ( u-healthcare ) service , which is an individualized health management system using advanced medical information technology . RESEARCH DESIGN AND METHODS We conducted a 6-month r and omized , controlled clinical trial involving 144 patients aged > 60 years . Participants were r and omly assigned to receive routine care ( control , n = 48 ) , to the self-monitored blood glucose ( SMBG , n = 47 ) group , or to the u-healthcare group ( n = 49 ) . The primary end point was the proportion of patients achieving A1C without hypoglycemia at 6 months . U-healthcare system refers to an individualized medical service in which medical instructions are given through the patient ’s mobile phone . Patients receive a glucometer with a public switched telephone network-connected cradle that automatically transfers test results to a hospital-based server . Once the data are transferred to the server , an automated system , the CDSS rule engine , generates and sends patient-specific messages by mobile phone . RESULTS After 6 months of follow-up , the mean A1C level was significantly decreased from 7.8 ± 1.3 % to 7.4 ± 1.0 % ( P proportion of patients with A1C was 30.6 % in the u-healthcare group , 23.4 % in the SMBG group ( 23.4 % ) , and 14.0 % in the control group ( P u-healthcare service achieved better glycemic control with less hypoglycemia than SMBG and routine care and may provide effective and safe diabetes management in the elderly diabetic patients",
"OBJECTIVE Large amounts of time and effort are needed to implement an Internet-based glucose monitoring system ( IBGMS ) in the clinical setting . This study was design ed using research experience that was developed while implementing an IBGMS in Korea , and the research platform was modified to evaluate the efficacy of an IBGMS in controlling blood sugar in the Chinese population . METHODS A r and omized , open-label , parallel group design was used to evaluate the efficacy of an IBGMS among Chinese subjects with type 2 diabetes . Over a 6-month period , 182 subjects were evaluated in the IBGMS ( n = 92 ) or control ( n = 90 ) groups . RESULTS After 3 months , the control group 's HbA1c levels were reduced from 8.0 % ± 0.8 % to 7.3 % ± 1.2 % ( p and IBGMS groups were significant at the 3-month ( p = 0.002 ) and 6-month ( p HbA1c levels in the control group increased slightly ( 7.3 % ± 1.1 % to 7.4 % ± 1.3 % , p = 0.605 ) , and the HbA1c levels in the IBGMS group decreased slightly ( 6.9 % ± 0.7 % to 6.7 % ± 0.7 % , p = 0.081 ) . CONCLUSIONS The IBGMS was effective in improving blood sugar levels among patients with diabetes . Therefore , IBGMS experience can be effectively transferred between institutions and countries",
"Purpose The purpose of this study was to evaluate the effectiveness of integrative health ( IH ) coaching on psychosocial factors , behavior change , and glycemic control in patients with type 2 diabetes . Methods Fifty-six patients with type 2 diabetes were r and omized to either 6 months of IH coaching or usual care ( control group ) . Coaching was conducted by telephone for fourteen 30-minute sessions . Patients were guided in creating an individualized vision of health , and goals were self-chosen to align with personal values . The coaching agenda , discussion topics , and goals were those of the patient , not the provider . Preintervention and postintervention assessment s measured medication adherence , exercise frequency , patient engagement , psychosocial variables , and A1C . Results Perceived barriers to medication adherence decreased , while patient activation , perceived social support , and benefit finding all increased in the IH coaching group compared with those in the control group . Improvements in the coaching group alone were also observed for self-reported adherence , exercise frequency , stress , and perceived health status . Coaching participants with elevated baseline A1C ( ≥7 % ) significantly reduced their A1C . Conclusions A coaching intervention focused on patients ’ values and sense of purpose may provide added benefit to traditional diabetes education programs . Fundamentals of IH coaching may be applied by diabetes educators to improve patient self-efficacy , accountability , and clinical outcomes",
"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 Effective self-management of diabetes is essential for the reduction of diabetes-related complications , as global rates of diabetes escalate . Methods R and omised controlled trial . Adults with type 2 diabetes ( n = 120 ) , with HbA1c greater than or equal to 7.5 % , were r and omly allocated ( 4 × 4 block r and omised block design ) to receive an automated , interactive telephone-delivered management intervention or usual routine care . Baseline sociodemographic , behavioural and medical history data were collected by self-administered question naires and biological data were obtained during hospital appointments . Health-related quality of life ( HRQL ) was measured using the SF-36 . Results The mean age of participants was 57.4 ( SD 8.3 ) , 63 % of whom were male . There were no differences in demographic , socioeconomic and behavioural variables between the study arms at baseline . Over the six-month period from baseline , participants receiving the Australian TLC ( Telephone-Linked Care ) Diabetes program showed a 0.8 % decrease in geometric mean HbA1c from 8.7 % to 7.9 % , compared with a 0.2 % HbA1c reduction ( 8.9 % to 8.7 % ) in the usual care arm ( p = 0.002 ) . There was also a significant improvement in mental HRQL , with a mean increase of 1.9 in the intervention arm , while the usual care arm decreased by 0.8 ( p = 0.007 ) . No significant improvements in physical HRQL were observed . Conclusions These analyses indicate the efficacy of the Australian TLC Diabetes program with clinical ly significant post-intervention improvements in both glycaemic control and mental HRQL . These observed improvements , if supported and maintained by an ongoing program such as this , could significantly reduce diabetes-related complications in the longer term . Given the accessibility and feasibility of this kind of program , it has strong potential for providing effective , ongoing support to many individuals with diabetes in the future",
"Background The Whole Systems Demonstrator was a large , pragmatic , cluster r and omised trial that compared telehealth with usual care among 3,230 patients with long-term conditions in three areas of Engl and . Telehealth involved the regular transmission of physiological information such as blood glucose to health professionals working remotely . We examined whether telehealth led to changes in glycosylated haemoglobin ( HbA1c ) among the subset of patients with type 2 diabetes . Methods The general practice electronic medical record was used as the source of information on HbA1c . Effects on HbA1c were assessed using a repeated measures model that included all HbA1c readings recorded during the 12-month trial period , and adjusted for differences in HbA1c readings recorded before recruitment . Secondary analysis averaged multiple HbA1c readings recorded for each individual during the trial period . Results 513 of the 3,230 participants were identified as having type 2 diabetes and thus were included in the study . Telehealth was associated with lower HbA1c than usual care during the trial period ( difference 0.21 % or 2.3 mmol/mol , 95 % CI , 0.04 % to 0.38 % , p = 0.013 ) . Among the 457 patients in the secondary analysis , mean HbA1c showed little change for controls following recruitment , but fell for intervention patients from 8.38 % to 8.15 % ( 68 to 66 mmol/mol ) . A higher proportion of intervention patients than controls had HbA1c below the 7.5 % ( 58 mmol/mol ) threshold that was targeted by general practice s ( 30.4 % vs. 38.0 % ) . This difference , however , did not quite reach statistical significance ( adjusted odds ratio 1.63 , 95 % CI , 0.99 to 2.68 , p = 0.053 ) . Conclusions Telehealth modestly improved glycaemic control in patients with type 2 diabetes over 12 months . The scale of the improvements is consistent with previous meta-analyses , but was relatively modest and seems unlikely to produce significant patient benefit . Trial registration numberInternational St and ard R and omized Controlled Trial Number Register IS RCT N43002091",
"Numerous diabetes-management systems and programs for improving glycemic control to meet guideline targets have been proposed , using IT technology . But all of them allow only limited-or no-real-time interaction between patients and the system in terms of system response to patient input ; few studies have effectively assessed the systems ' usability and feasibility to determine how well patients underst and and can adopt the technology involved . DialBetics is composed of 4 modules : ( 1 ) data transmission module , ( 2 ) evaluation module , ( 3 ) communication module , and ( 4 ) dietary evaluation module . A 3-month r and omized study was design ed to assess the safety and usability of a remote health- data monitoring system , and especially its impact on modifying patient lifestyles to improve diabetes self-management and , thus , clinical outcomes . Fifty-four type 2 diabetes patients were r and omly divided into 2 groups , 27 in the DialBetics group and 27 in the non-DialBetics control group . HbA1c and fasting blood sugar ( FBS ) values declined significantly in the DialBetics group : HbA1c decreased an average of 0.4 % ( from 7.1 ± 1.0 % to 6.7 ± 0.7 % ) compared with an average increase of 0.1 % in the non-DialBetics group ( from 7.0 ± 0.9 % to 7.1 ± 1.1 % ) ( P = .015 ) ; The DialBetics group FBS decreased an average of 5.5 mg/dl compared with a non-DialBetics group average increase of 16.9 mg/dl ( P = .019 ) . BMI improvement-although not statistically significant because of the small sample size-was greater in the DialBetics group . DialBetics was shown to be a feasible and an effective tool for improving HbA1c by providing patients with real-time support based on their measurements and inputs",
"BACKGROUND We compared telecare and conventional self-monitored blood glucose ( SMBG ) programs for titrating the addition of one bolus injection of insulin glulisine in patients with type 2 diabetes uncontrolled on oral hypoglycemic agents for ≥3 months who were first titrated with basal insulin glargine . METHODS This r and omized , multicenter , parallel-group study included 241 patients ( mean screening glycosylated hemoglobin [ HbA(1c ) ] , 8.8 % [ 73 mmol/mol ] ) . In the run-in phase , any antidiabetes medication , except for metformin , was discontinued . Metformin was then up-titrated to 2 g/day ( 1 g twice daily ) until study completion . Following run-in , all patients started glargine for 8 - 16 weeks , targeting fasting plasma glucose ( FPG ) ≤5.6 mmol/L using conventional SMBG . Patients with FPG ≤7 mmol/L added a glulisine dose at the meal with the highest postpr and ial plasma glucose excursion , titrated to target 2-h postpr and ial plasma glucose level using telecare or SMBG for 24 weeks . Patients with FPG > 7 mmol/L at week 16 were withdrawn from the study . RESULTS After glargine titration , 224 patients achieved FPG ≤7 mmol/L , without any difference between telecare and SBMG groups ( mean±SD , 6.2±0.8 vs. 6.0±0 . 9 mmol/L , respectively ) . HbA(1c ) levels were lower following titration and were similar for telecare and SMBG ( 7.9±0.9 % vs. 7.8±0.9 % [ 63 vs. 62 mmol/mol ] , respectively ) . Adding glulisine further reduced HbA(1c ) in both groups ( -0.7 % vs. -0.7 % ) ; 45.2 % and 54.8 % ( P=0.14 ) , respectively , of patients achieved HbA(1c ) ≤7.0 % ( ≤53 mmol/mol ) . Weight change and hypoglycemia were similar between groups . CONCLUSIONS Patients adding one dose of glulisine at the meal with the highest postpr and ial plasma glucose excursion to titrated basal glargine achieved comparable improvements in glycemic control irrespective of traditional or telecare blood glucose monitoring",
"OBJECTIVE To determine whether a culturally appropriate clinic- and community-based intervention for African-American women with type 2 diabetes will increase moderate-intensity physical activity ( PA ) . RESEARCH DESIGN AND METHODS In this r and omized controlled trial conducted at seven practice s in central North Carolina , 200 African-American women , > or = 40 years of age with type 2 diabetes , were r and omized to one of three treatment conditions : clinic and community ( group A ) , clinic only ( group B ) , or minimal intervention ( group C ) . The clinic-based intervention ( groups A and B ) consisted of four monthly visits with a nutritionist who provided counseling to enhance PA and dietary intake that was tailored to baseline practice s and attitudes ; the community-based intervention ( group A ) consisted of three group sessions and 12 monthly phone calls from a peer counselor and was design ed to provide social support and reinforce behavior change goals ; and the minimal intervention ( group C ) consisted of educational pamphlets mailed to participants . The primary study outcome was the comparison of PA levels between groups assessed at 6 and 12 months by accelerometer , which was worn while awake for 7 days . RESULTS Totals of 175 ( 88 % ) and 167 ( 84 % ) participants completed PA assessment at 6 and 12 months , respectively . For comparison of PA , the P value for overall group effect was 0.014 . Comparing group A with C , the difference in the average adjusted mean for PA was 44.1 kcal/day ( 95 % CI 13.1 - 75.1 , P = 0.0055 ) . Comparing group B with C , the difference in the average adjusted mean was 33.1 kcal/day ( 95 % CI 3.3 - 62.8 , P = 0.029 ) . The intervention was acceptable to participants : 88 % were very satisfied with clinic-based counseling to enhance PA , and 86 % indicated that the peer counselor 's role in the program was important . CONCLUSIONS The intervention was associated with a modest enhancement of PA and was acceptable to participants",
"We conducted a r and omized controlled trial for 12 weeks in patients with type 2 diabetes living in a rural part of Korea . The intervention group ( n = 35 ) was managed by a diabetes centre which provided specialized management mediated by a primary health-care nurse who used a PDA-type blood glucometer with a bar code detector to measure the capillary glucose levels . The control group ( n = 36 ) received usual care . Compared with baseline , HbA1c was significantly reduced at three-month follow-up in the intervention group ( 8.0 % vs. 7.5 % ; P group . Total cholesterol was significantly reduced in the intervention group ( 10.7 mmol/L vs. 10.4 mmol/L ; P = 0.043 ) . Fasting plasma glucose and triglyceride levels were lower at follow-up in both groups , but the difference was not significant . The new system could be implemented widely and would contribute to improving the quality of diabetes care , even in isolated rural areas",
"OBJECTIVE To compare the effectiveness of a telephonic and a print intervention over 1 year to improve diabetes control in low-income urban adults . RESEARCH DESIGN AND METHODS A r and omized trial in Spanish and English comparing a telephonic intervention implemented by health educators with a print intervention . Participants ( N = 526 ) had an A1C ≥7.5 % and were prescribed one or more oral agents . All were members of a union/employer jointly sponsored health benefit plan . Health coverage included medications . Primary outcomes were A1C and pharmacy cl aims data ; secondary outcomes included self-report of two medication adherence measures and other self-care behaviors . RESULTS Participants were 62 % black and 23 % Hispanic ; 77 % were foreign born , and 42 % had annual family incomes . Baseline median A1C was 8.6 % ( interquartile range 8.0–10.0 ) . Insulin was also prescribed for 24 % of participants . The telephone group had mean ± SE decline in A1C of 0.23 ± 0.11 % over 1 year compared with a rise of 0.13 ± 0.13 % for the print group ( P = 0.04 ) . After adjusting for baseline A1C , sex , age , and insulin use , the difference in A1C was 0.40 % ( 95 % CI 0.10–0.70 , P = 0.009 ) . Change in medication adherence measured by cl aims data , but not by self-report measures , was significantly associated with change in A1C ( P = 0.01 ) . Improvement in medication adherence was associated ( P = 0.005 ) with the telephonic intervention , but only among those not taking insulin . No diabetes self-care activities were significantly correlated with the change in A1C . CONCLUSIONS A 1-year tailored telephonic intervention implemented by health educators was successful in significantly , albeit modestly , improving diabetes control compared with a print intervention in a low-income , insured , minority population",
"OBJECTIVE To conduct a 1-year r and omized clinical trial to evaluate a remote comprehensive diabetes self-management education ( DSME ) intervention , Diabetes TeleCare , administered by a dietitian and nurse/certified diabetes educator ( CDE ) in the setting of a federally qualified health center ( FQHC ) in rural South Carolina . RESEARCH DESIGN AND METHODS Participants were recruited from three member health centers of an FQHC and were r and omized to either Diabetes TeleCare , a 12-month , 13-session curriculum delivered using telehealth strategies , or usual care . RESULTS Mixed linear regression model results for repeated measures showed a significant reduction in glycated hemoglobin ( GHb ) in the Diabetes TeleCare group from baseline to 6 and 12 months ( 9.4 ± 0.3 , 8.3 ± 0.3 , and 8.2 ± 0.4 , respectively ) compared with usual care ( 8.8 ± 0.3 , 8.6 ± 0.3 , and 8.6 ± 0.3 , respectively ) . LDL cholesterol was reduced at 12 months in the Diabetes TeleCare group compared with usual care . Although not part of the original study design , GHb was reduced from baseline to 12 and 24 months in the Diabetes TeleCare group ( 9.2 ± 0.4 , 7.4 ± 0.5 , and 7.6 ± 0.5 , respectively ) compared with usual care ( 8.7 ± 0.4 , 8.1 ± 0.4 , and 8.1 ± 0.5 , respectively ) in a post hoc analysis of a subset of the r and omized sample who completed a 24-month follow-up visit . CONCLUSIONS Telehealth effectively created access to successfully conduct a 1-year remote DSME by a nurse CDE and dietitian that improved metabolic control and reduced cardiovascular risk in an ethnically diverse and rural population",
"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",
"Aims /hypothesisAfter achieving glycaemic control , many type 2 diabetic patients relapse to clinical ly significant levels of hyperglycaemia . We sought to determine the optimal frequency of telephone contact by nurse practitioners that was necessary to prevent glycaemic relapse . Methods This parallel , r and omised controlled trial ran from June 2002 to February 2006 at an academic medical centre , study ing 164 type 2 diabetic patients who had recently achieved glycaemic control . Participants were r and omly assigned by sequential , concealed , computer-generated allocation to a 2 year maintenance strategy consisting of : ( 1 ) routine follow-up ( n = 54 ) ; ( 2 ) routine follow-up and quarterly telephone contact ( n = 55 ) ; or ( 3 ) routine follow-up and monthly telephone contact ( n = 55 ) . Blinding was not possible . The primary outcome was cumulative incidence of glycaemic relapse , defined as an increase in HbA1c of ≥1 % ; all participants were analysed . Cumulative incidence and prevalent proportions were compared . Weight change and hypoglycaemia were also assessed . Results All participants r and omised were included in the analyses . The study was completed by 90 % of participants and intervention fidelity was high . At 24 months , the cumulative incidence of relapse was 41 % . At 12 months , prevalent proportions of relapse were 20 % , 14 % and 15 % for control , quarterly contact and monthly contact , respectively . At 24 months , they were 25 % , 21 % and 29 % , respectively . There was no statistically significant difference in cumulative incidence or prevalent proportions of relapse among the study arms . Adverse events did not differ between study arms . Conclusions /interpretationThis first r and omised controlled trial to test an intervention to prevent glycaemic relapse found that regularly scheduled telephone contact by a nurse practitioner was no more effective than routine follow-up care in preventing glycaemic relapse . Trial registration : Clinical Trials.gov NCT00362193 Funding : The research was supported by the National Institute of Diabetes and Digestive and Kidney Disease R18 DK 062258 , P60 DK 020593 and K24 DK 077875 . M. M. Huizinga was supported by National Institute of Environmental Health Sciences 1 K12 ES 015855 and National Center for Research Re sources 5 K12 RR 023266",
"OBJECTIVES To investigate the acceptability and feasibility of using short message services ( SMS ) via cell phones to ensure adherence to management prescriptions by diabetic patients . METHODS Type 2 diabetic patients with 5 or more years of diabetes and having HbA1c between 7.0 % to 10 % were r and omized to the control arm ( n = 105 ) to receive st and ard care and to the intervention arm ( SMS , n = 110 ) . Messages in English on principles of diabetes management were sent once in 3 days , the contents and frequencies varied as per the patients ' preferences . The study duration was 1 year . All participants were advised to report for quarterly clinic visits . A comparative assessment of the clinical , biochemical and anthropometric outcomes was made among the groups at the annual visit . RESULTS Annual review was possible in 71 % of intervention group and 63 % of control group . SMS was acceptable to the patients and the median number requested was 2 per week . HbA1c and plasma lipids improved significantly in the SMS group . CONCLUSIONS The pilot study showed that frequent communication via SMS was acceptable to diabetic patients and it helped to improve the health outcomes",
"Abstract Background : Overseeing proper insulin initiation and titration remains a challenging task in diabetes care . Recent advances in mobile technology have enabled new models of collaborative care between patients and healthcare providers ( HCPs ) . We hypothesized that the adoption of such technology could help individuals starting basal insulin achieve better glycemic control compared with st and ard clinical practice . Material s and Methods : This was a 12 ± 2-week r and omized controlled study with 40 individuals with type 2 diabetes who were starting basal insulin due to poor glycemic control . The control group ( n = 20 ) received st and ard face-to-face care and phone follow-up as needed in a tertiary center , whereas the intervention group ( n = 20 ) received care through the cloud-based diabetes management program where regular communications about glycemic control and insulin doses were conducted via patient self-tracking tools , shared decision-making interfaces , secure text messages , and virtual visits ( audio , video , and shared screen control ) instead of office visits . Results : By intention-to-treat analysis , the intervention group achieved a greater hemoglobin A1c decline compared with the control group ( 3.2 ± 1.5 % vs. 2.0 % ± 2.0 % ; P = 0.048 ) . The Diabetes Treatment Satisfaction Question naire showed a significant improvement in the intervention group compared with the control group ( an increase of 10.1 ± 11.7 vs. 2.1 ± 6.5 points ; P = 0.01 ) . HCPs spent less time with patients in the intervention group compared with those in the control group ( 65.9 min per subject vs. 81.6 min per subject ) . However , the intervention group required additional training time to use the mobile device . Conclusions : Mobile health technology could be an effective tool in sharing data , enhancing communication , and improving glycemic control while enabling collaborative decision making in diabetes care",
"Background Self-management is crucial in the daily management of type 2 diabetes . It has been suggested that mHealth may be an important method for enhancing self-management when delivered in combination with health counseling . Objective The objective of this study was to test whether the use of a mobile phone – based self-management system used for 1 year , with or without telephone health counseling by a diabetes specialist nurse for the first 4 months , could improve glycated hemoglobin A1c ( HbA1c ) level , self-management , and health-related quality of life compared with usual care . Methods We conducted a 3-arm prospect i ve r and omized controlled trial involving 2 intervention groups and 1 control group . Eligible participants were persons with type 2 diabetes with an HbA1c level ≥7.1 % ( ≥54.1 mmol/mol ) and aged ≥18 years . Both intervention groups received the mobile phone – based self-management system Few Touch Application ( FTA ) . The FTA consisted of a blood glucose – measuring system with automatic wireless data transfer , diet manual , physical activity registration , and management of personal goals , all recorded and operated using a diabetes diary app on the mobile phone . In addition , one intervention group received health counseling based on behavior change theory and delivered by a diabetes specialist nurse for the first 4 months after r and omization . All groups received usual care by their general practitioner . The primary outcome was HbA1c level . Secondary outcomes were self-management ( heiQ ) , health-related quality of life ( SF-36 ) , depressive symptoms ( CES-D ) , and lifestyle changes ( dietary habits and physical activity ) . Data were analyzed using univariate methods ( t test , ANOVA ) and multivariate linear and logistic regression . Results A total of 151 participants were r and omized : 51 to the FTA group , 50 to the FTA-health counseling ( FTA-HC ) group , and 50 to the control group . Follow-up data after 1 year were available for 120 participants ( 79 % ) . HbA1c level decreased in all groups , but did not differ between groups after 1 year . The mean change in the heiQ domain skills and technique acquisition was significantly greater in the FTA-HC group after adjusting for age , gender , and education ( P=.04 ) . Other secondary outcomes did not differ between groups after 1 year . In the FTA group , 39 % were substantial users of the app ; 34 % of the FTA-HC group were substantial users . Those aged ≥63 years used the app more than their younger counterparts did ( OR 2.7 ; 95 % CI 1.02 - 7.12 ; P=.045 ) . Conclusions The change in HbA1c level did not differ between groups after the 1-year intervention . Secondary outcomes did not differ between groups except for an increase in the self-management domain of skill and technique acquisition in the FTA-HC group . Older participants used the app more than the younger participants did",
"OBJECTIVES We tested the effectiveness of a culturally tailored , behavioral theory-based community health worker intervention for improving glycemic control . METHODS We used a r and omized , 6-month delayed control group design among 164 African American and Latino adult participants recruited from 2 health systems in Detroit , Michigan . Our study was guided by the principles of community-based participatory research . Hemoglobin A1c ( HbA1c ) level was the primary outcome measure . Using an empowerment-based approach , community health workers provided participants with diabetes self-management education and regular home visits , and accompanied them to a clinic visit during the 6-month intervention period . RESULTS Participants in the intervention group had a mean HbA1c value of 8.6 % at baseline , which improved to a value of 7.8 % at 6 months , for an adjusted change of -0.8 percentage points ( P mean HbA1c among the control group ( 8.5 % ) . Intervention participants also had significantly greater improvements in self-reported diabetes underst and ing compared with the control group . CONCLUSIONS This study contributes to the growing evidence for the effectiveness of community health workers and their role in multidisciplinary teams engaged in culturally appropriate health care delivery",
"This study was performed to evaluate the effects of a patient-centered , tablet computer-based self-monitoring system for chronic disease care . A 3-month r and omized controlled pilot trial was conducted to compare the use of a computer-based self-monitoring system in disease self-care ( intervention group ; n = 33 ) with a conventional self-monitoring method ( control group ; n = 30 ) in patients with type 2 diabetes mellitus and /or hypertension . The system was equipped with a 2-in-1 blood glucose and blood pressure monitor , a reminder feature , and video-based educational material s for the care of the two chronic diseases . The control patients were given only the 2-in-1 monitor for self-monitoring . The outcomes reported here included the glycated hemoglobin ( HbA1c ) level , fasting blood glucose level , systolic blood pressure , diastolic blood pressure , chronic disease knowledge , and frequency of self-monitoring . The data were collected at baseline and at 1- , 2- , and 3-month follow-up visits . The patients in the intervention group had a significant decrease in mean systolic blood pressure from baseline to 1 month ( p mean diastolic blood pressure were seen in the intervention group compared with the control group after 1 month ( p fasting blood glucose level , the HbA1c level , or chronic disease knowledge . The frequency of self-monitoring of blood glucose level and blood pressure was similar in both groups . The performances of the tablet computer-assisted and conventional disease self-monitoring appear to be useful to support/maintain blood pressure and diabetes control . The beneficial effects of the use of electronic self-care re sources and support provided via mobile technologies require further confirmation in longer-term , larger trials",
"AIMS We evaluate the efficacy of the \" Active Body Control ( ABC ) Program \" for weight reduction in patients with type 2 diabetes . METHODS The ABC program combines telemonitoring of the physical activity with a low-calorie diet also preferring carbohydrates with low glycemic indexes . In this 6-month , r and omized , clinical trial 35 patients ( aged 57 ± 9 years ; BMI = 35.3 ± 5.7 kg/m(2 ) ) were treated according to the ABC program and 35 control patients ( aged 58 ± 7 years ; BMI = 34.8 ± 5.9 kg/m(2 ) ) received st and ard therapy . RESULTS After 6 months the mean weight loss in the intervention group was 11.8 kg ± 8.0 kg . Glucose and HbA1c were lowered by respectively 1.0 mmol/l and 0.8 percentage points ( p=0.000 , respectively ) . The proportion of patients with HbA1c>7 % fell from 57 % to 26 % . Antidiabetic drugs were discontinued in 13 patients ( 39 % ) and reduced in 14 ( 42 % ) . The reduction of costs on medication per patient was € 83 in 6 months . In the control group , there were no relevant changes in body weight , laboratory values or drug treatment . CONCLUSIONS The ABC program effectively lowers body weight , Hb1Ac and antidiabetic drug use in patients with type 2 diabetes",
"OBJECTIVE To assess the magnitude and independence of the effects of routine blood pressure lowering and intensive glucose control on clinical outcomes in patients with long-st and ing type 2 diabetes . RESEARCH DESIGN AND METHODS This was a multicenter , factorial r and omized trial of perindopril-indapamide versus placebo ( double-blind comparison ) and intensive glucose control with a gliclazide MR – based regimen ( target A1C ≤6.5 % ) versus st and ard glucose control ( open comparison ) in 11,140 participants with type 2 diabetes who participated in the Action in Diabetes and Vascular Disease : Preterax and Diamicron MR Controlled Evaluation ( ADVANCE ) trial . Annual event rates and risks of major macrovascular and microvascular events considered jointly and separately , renal events , and death during an average 4.3 years of follow-up were assessed , using Cox proportional hazards models . RESULTS There was no interaction between the effects of routine blood pressure lowering and intensive glucose control for any of the prespecified clinical outcomes ( all P > 0.1 ) : the separate effects of the two interventions for the renal outcomes and death appeared to be additive on the log scale . Compared with neither intervention , combination treatment reduced the risk of new or worsening nephropathy by 33 % ( 95 % CI 12–50 % , P = 0.005 ) , new onset of macroalbuminuria by 54 % ( 35–68 % , P and new onset of microalbuminuria by 26 % ( 17–34 % ) . Combination treatment was associated with an 18 % reduction in the risk of all-cause death ( 1–32 % , P = 0.04 ) . CONCLUSIONS The effects of routine blood pressure lowering and intensive glucose control were independent of one another . When combined , they produced additional reductions in clinical ly relevant outcomes",
"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 We compared the short-term efficacy of home telemonitoring coupled with active medication management by a nurse practitioner with a monthly care coordination telephone call on glycemic control in veterans with type 2 diabetes and entry A1C ≥7.5 % . RESEARCH DESIGN AND METHODS Veterans who received primary care at the VA Pittsburgh Healthcare System from June 2004 to December 2005 , who were taking oral hypoglycemic agents and /or insulin for ≥1 year , and who had A1C ≥7.5 % at enrollment were r and omly assigned to either active care management with home telemonitoring ( ACM+HT group , n = 73 ) or a monthly care coordination telephone call ( CC group , n = 77 ) . Both groups received monthly calls for diabetes education and self-management review . ACM+HT group participants transmitted blood glucose , blood pressure , and weight to a nurse practitioner using the Viterion 100 TeleHealth Monitor ; the nurse practitioner adjusted medications for glucose , blood pressure , and lipid control based on established American Diabetes Association targets . Measures were obtained at baseline , 3-month , and 6-month visits . RESULTS Baseline characteristics were similar in both groups , with mean A1C of 9.4 % ( CC group ) and 9.6 % ( ACM+HT group ) . Compared with the CC group , the ACM+HT group demonstrated significantly larger decreases in A1C at 3 months ( 1.7 vs. 0.7 % ) and 6 months ( 1.7 vs. 0.8 % ; P ACM+HT group demonstrated significantly greater reductions in A1C by 3 and 6 months . However , both interventions improved glycemic control in primary care patients with previously inadequate control",
"OBJECTIVE We evaluated automated telephone disease management ( ATDM ) with telephone nurse follow-up as a strategy for improving diabetes treatment processes and outcomes in Department of Veterans Affairs ( VA ) clinics . We also compared the results with those of a prior ATDM trial conducted in a county health care system . RESEARCH DESIGN AND METHODS A total of 272 VA patients with diabetes using hypoglycemic medications were r and omized . During the 1-year study period , intervention patients received biweekly ATDM health assessment and self-care education calls , and a nurse educator followed up with patients based on their ATDM assessment reports . Telephone surveys were used to measure patients ' self-care , symptoms , and satisfaction with care . Outpatient service use was evaluated using electronic data bases and self-reports , and glycemic control was measured by HbA1c and serum glucose testing . RESULTS At 12 months , intervention patients reported more frequent glucose self-monitoring and foot inspections than patients receiving usual care and were more likely to be seen in podiatry and diabetes specialty clinics . Intervention patients also were more likely than control patients to have had a cholesterol test . Among patients with baseline HbA1c levels > or = 8 % , mean end-point values were lower among intervention patients than control patients ( 8.7 vs. 9.2 % , respectively ; P = 0.04 ) . Among intervention and control patients with baseline values > or = 9 % , mean end-point values were 9.1 and 10.2 % , respectively ( P = 0.04 ) . At follow-up , intervention patients reported fewer symptoms of poor glycemic control than control patients and greater satisfaction with their health care . CONCLUSIONS This intervention improved the quality of VA diabetes care . Intervention effects for most end points replicated findings from the prior county clinic trial , although intervention-control differences in the current study were smaller because of the relatively good self-care and health status among the current study 's enrollees",
" This article describes the design and implementation of an online diabetes self-management intervention for a sample of inner-city African Americans with diabetes . Study participants were r and omly assigned to the treatment ( 26 ) and control ( 21 ) conditions . The results indicate that treatment group participants were more likely to achieve positive outcomes in terms of lowered hemoglobin A1c and body mass index measurements than were control group members . These findings support the development of telehealth interventions to promote effective chronic disease management in medically underserved communities",
"CONTEXT Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions and lower access to care . OBJECTIVES To examine the effectiveness of a telemedicine intervention to achieve clinical management goals in older , ethnically diverse , medically underserved patients with diabetes . DESIGN , Setting , and Patients A r and omized controlled trial was conducted , comparing telemedicine case management to usual care , with blinded outcome evaluation , in 1,665 Medicare recipients with diabetes , aged > /= 55 years , residing in federally design ated medically underserved areas of New York State . Interventions Home telemedicine unit with nurse case management versus usual care . Main Outcome Measures The primary endpoints assessed over 5 years of follow-up were hemoglobin A1c ( HgbA1c ) , low density lipoprotein ( LDL ) cholesterol , and blood pressure levels . RESULTS Intention-to-treat mixed models showed that telemedicine achieved net overall reductions over five years of follow-up in the primary endpoints ( HgbA1c , p = 0.001 ; LDL , p systolic and diastolic blood pressure , p = 0.024 ; p HgbA1c , 3.84 ( -0.08 , 7.77 ) mg/dL for LDL cholesterol , and 4.32 ( 1.93 , 6.72 ) mm Hg for systolic and 2.64 ( 1.53 , 3.74 ) mm Hg for diastolic blood pressure . There were 176 deaths in the intervention group and 169 in the usual care group ( hazard ratio 1.01 [ 0.82 , 1.24 ] ) . CONCLUSIONS Telemedicine case management result ed in net improvements in HgbA1c , LDL-cholesterol and blood pressure levels over 5 years in medically underserved Medicare beneficiaries . Mortality was not different between the groups , although power was limited . Trial Registration http:// clinical trials.gov Identifier : NCT00271739",
"Background : Obesity increases the risk of many health complications such as hypertension , coronary heart disease and type 2 diabetes , needs long-lasting treatment for effective results and involves high public and private care-costs . Therefore , it is imperative that enduring and low-cost clinical programs for obesity and related co-morbidities are developed and evaluated . Information and communication technologies ( ICT ) can help clinicians to deliver treatment in a cost-effective and time-saving manner to a large number of obese individuals with co-morbidities . Objective : To examine ad interim effectiveness of a 12-month multidisciplinary telecare intervention for weight loss provided to obese patients with type 2 diabetes . Design , Setting , and Participants : A single-center r and omized controlled trial ( TECNOB study ) started in December 2008 . At present , 72 obese patients with type 2 diabetes have been recruited and r and omly allocated to the TECNOB program ( n=37 ) or to a control condition ( n=39 ) . However , only 34 participants have completed at least the 3-month follow-up and have been included in this ad interim analysis . 21 out of them have reached also the 6-month follow-up and 13 have achieved the end of the program . Study is still on-going . Intervention : All participants attended 1-month inpatient intensive program that involved individualized medical care , diet therapy , physical training and brief psychological counseling . At discharge , participants allocated to the TECNOB program were instructed to use a weight-loss web-site , a web-based videoconference tool , a dietary software installed into their cellular phones and an electronic armb and measuring daily steps and energy expenditure . Main Outcome Measures : Weight and disordered eating-related behaviors and cognitions ( EDI-2 ) at entry to hospital , at discharge from hospital , at 3,6 and 12 months . Results : Ad interim analysis of data from 34 participants showed no statistically significant difference between groups in weight change at any time-point . However , within-group analysis revealed significant reductions of initial weight at discharge from hospital , at 3 months , at 6 months but not at 12 months . Control group had higher scores in Interpersonal distrust at 12 months . Conclusion : This ad interim findings revealed that the effect of the inpatient treatment was high and probably overwhelmed the effect of the TECNOB intervention . Much statistical power and long-term follow-up may enhance the probability to detect the TECNOB effect over and above the great one exerted by the inpatient program",
"OBJECTIVE —To determine 1 ) whether participants in the Spanish Diabetes Self-Management Program ( SDSMP ) , when compared at 6 months to r and omized control subjects , would demonstrate improvements in health status , health behaviors , and self-efficacy ; and 2 ) whether SDSMP participants receiving monthly automated telephone reinforcement would maintain improvements at 18 months better than those not receiving reinforcement . RESEARCH DESIGN AND METHODS —A total of 567 Spanish-speaking adults with type 2 diabetes were r and omized to a usual-care control group or 6-week community-based , peer-led SDSMP . SDSMP participants were re-r and omized to receive 15 months of automated telephone messages or no reinforcement . A1C was measured at baseline and 6 and 18 months . All other data were collected by self-administered question naires . RESULTS —At 6 months SDSMP participants compared with control subjects demonstrated improvements in A1C ( −0.4 % ) , health distress , symptoms of hypo- and hyperglycemia , and self-efficacy ( P SDSMP participants also demonstrated improvements in self-rated health and communication with physicians , had fewer emergency room visits ( −0.18 visits in 6 months , P fewer visits to physicians . At 18 months the only difference between reinforced and nonreinforced participants was increased glucose monitoring for the reinforcement group . CONCLUSIONS —The SDSMP demonstrated effectiveness in lowering A1C and improving health status . Reinforcement did not add to its effectiveness . Given the high needs of the Spanish-speaking population , the SDSMP deserves consideration for implementation",
"OBJECTIVE Investigate the effectiveness of an educational intervention that used both the cellular phone with a short messaging service ( SMS ) and the Internet on the glycemic control of the patients with type 2 diabetes mellitus . METHODS Twenty-five patients were r and omly assigned to an intervention group and twenty-six to a control group . The intervention was applied for 12 months . The goal of the intervention was to keep blood glucose concentrations close to the normal range ( HbA(1)c access a website by using a cellular phone or to wiring the Internet and input their blood glucose levels weekly . Participants were sent the optimal recommendations by both cellular phone and the Internet weekly . RESULTS Participants in the intervention group had lower HbA(1)c over 12 months when compared with the control group . At 12 months the change from baseline in HbA(1)c was -1.32 in the intervention group versus + 0.81 in the control group . Two hours post-meal glucose ( 2HPMG ) had a significantly greater decline in the intervention group after 12 months when compared with the control group ( -100.0 versus + 18.1mg/dl ) . CONCLUSION This educational intervention using the Internet and a SMS by cellular phone rapidly improved and stably maintained the glycemic control of the patients with type 2 diabetes mellitus",
"This study evaluated the 12-month follow-up results and costs of a personalized , medical office-based intervention focused on behavioral issues related to dietary self-management . Two hundred and six adults having diabetes attending an internal medicine outpatient clinic visit were r and omized to either Usual Care or to Brief Intervention . The single session intervention involved touchscreen computer-assisted assessment that provided immediate feedback on key barriers to dietary self-management , goal setting and problem-solving counselling . Follow-up components included phone calls and videotape intervention relevant to each participant . Brief Intervention produced significantly greater improvement than Usual Care on multiple measures of change in dietary behaviour ( e.g. , covariate adjusted difference of 2.2 % of calories from fat ; p = 0.023 ) and on serum cholesterol levels ( covariate adjusted difference of 15 mg/dl ; p = 0.002 ) at 12-month follow-up . There were also significant differences favouring intervention on patient satisfaction ( p HbA1c levels . The costs of intervention ( $ 137 per patient ) were modest relative to many commonly used practice",
"OBJECTIVE —To investigate the long-term effectiveness of the Internet-based glucose monitoring system ( IBGMS ) on glucose control in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS —We conducted a prospect i ve , r and omized , controlled trial in 80 patients with type 2 diabetes for 30 months . The intervention group was treated with the IBGMS , while the control group made conventional office visits only . HbA1c ( A1C ) was performed at 3-month intervals . For measuring of the stability of glucose control , the SD value of A1C levels for each subject was used as the A1C fluctuation index ( HFI ) . RESULTS —The mean A1C and HFI were significantly lower in the intervention group ( n = 40 ) than in the control group ( n = 40 ) . ( A1C [ mean ± SD ] 6.9 ± 0.9 vs. 7.5 ± 1.0 % , P = 0.009 ; HFI 0.47 ± 0.23 vs. 0.78 ± 0.51 , P = 0.001 ; intervention versus control groups , respectively ) . Patients in the intervention group with a basal A1C ≥7 % ( n = 27 ) had markedly lower A1C levels than corresponding patients in the control group during the first 3 months and maintained more stable levels throughout the study ( P = 0.022 ) . Control patients with a basal A1C distribution of A1C levels , whereas the A1C levels in the intervention group remained stable throughout the study with low HFI . CONCLUSIONS —Long-term use of the IBGMS has proven to be superior to conventional diabetes care systems based on office visits for controlling blood glucose and achieving glucose stability ",
"Objective To evaluate the effectiveness of goal focused telephone coaching by practice nurses in improving glycaemic control in patients with type 2 diabetes in Australia . Design Prospect i ve , cluster r and omised controlled trial , with general practice s as the unit of r and omisation . Setting General practice s in Victoria , Australia . Participants 59 of 69 general practice s that agreed to participate recruited sufficient patients and were r and omised . Of 829 patients with type 2 diabetes ( glycated haemoglobin ( HbA1c ) > 7.5 % in the past 12 months ) who were assessed for eligibility , 473 ( 236 from 30 intervention practice s and 237 from 29 control practice s ) agreed to participate . Intervention Practice nurses from intervention practice s received two days of training in a telephone coaching programme , which aim ed to deliver eight telephone and one face to face coaching episodes per patient . Main outcome measures The primary end point was mean absolute change in HbA1c between baseline and 18 months in the intervention group compared with the control group . Results The intervention and control patients were similar at baseline . None of the practice s dropped out over the study period ; however , patient attrition rates were 5 % in each group ( 11/236 and 11/237 in the intervention and control group , respectively ) . The median number of coaching sessions received by the 236 intervention patients was 3 ( interquartile range 1 - 5 ) , of which 25 % ( 58/236 ) did not receive any coaching sessions . At 18 months ’ follow-up the effect on glycaemic control did not differ significantly ( mean difference 0.02 , 95 % confidence interval −0.20 to 0.24 , P=0.84 ) between the intervention and control groups , adjusted for HbA1c measured at baseline and the clustering . Other biochemical and clinical outcomes were similar in both groups . Conclusions A practice nurse led telephone coaching intervention implemented in the real world primary care setting produced comparable outcomes to usual primary care in Australia . The addition of a goal focused coaching role onto the ongoing generalist role of a practice nurse without prescribing rights was found to be ineffective . Trial registration Current Controlled Trials IS RCT N50662837",
"BACKGROUND Previous studies have provided limited guidance regarding the clinical efficacy and cost-effectiveness of interventions using \" telemedicine \" models in the management of diabetes mellitus . We conducted a study to determine if routine clinical assessment s of diabetes patients could be effectively conducted via computer and telephone interaction with patients and still provide clinical results similar to traditional office care . SUBJECTS AND METHODS We enrolled 100 subjects with diabetes in this 12-month , r and omized , controlled , non-inferiority study . Subjects were r and omized ( 1:1 ratio ) to a control group ( CG ) or study group ( SG ) . Baseline characteristics were similar . CG subjects participated in quarterly office visits ; SG subjects participated in two office visits ( months 6 and 12 ) and two telemedicine interactions ( months 3 and 9 ) . Changes in clinical measurements ( hemoglobin A1c [ HbA1c ] , blood pressure , lipids , body mass index [ BMI ] , and body weight ) and clinician time requirements were assessed . RESULTS Seventy subjects completed the study ( CG , n=37 ; SG , n=33 ) . No significant between-group differences in HbA1c , blood pressure , lipids , or BMI were seen at 12 months . SG subjects showed significantly greater reductions in mean ( SD ) body weight compared with CG subjects : -5.2 ( 1.6 ) pounds versus -0.7 ( 1.5 ) pounds , respectively ( P=0.04 ) . Clinician time requirements for SG subjects were reduced by > 40 % . CONCLUSIONS Our study demonstrated that use of a telemedicine-based treatment protocol in diabetes patients is feasible and efficient and yields similar clinical outcomes compared with traditional , clinic-based protocol s. Telemedicine applications of computer software can potentially exp and access to care for patients and may reduce costs for patients , providers , and payers",
"OBJECTIVE To investigate the effectiveness of shared care combined with telecare in type 2 diabetic patients in an underserved community in Asia . RESEARCH DESIGN AND METHODS In total , 95 patients with type 2 diabetes who had a glycosylated hemoglobin ( HbA1c ) level of > 7 % were recruited from six community health centers in remote areas in Changhua County , Taiwan . All patients were r and omly divided into intervention ( shared care combined with telecare ) and usual-care groups and followed up for 6 months . RESULTS The decrease in HbA1c level was significantly greater in the intervention group than in the usual-care group ( 0.7 ± 1.3 % versus 0.1 ± 1.0 % , p=0.03 ) . There were no significant differences in lipid profiles and blood pressure changes between the two groups . CONCLUSIONS Shared care combined with telecare could significantly reduce HbA1c levels in type 2 diabetic patients with poor glycemic control in underserved rural communities . Further studies should be conducted to clarify the target users and to develop cost-effective interventions",
"This study aim ed to test the effects of providing Web-based diabetes education to individuals with type 2 diabetes on the A1c level and health check attendance . The study participants comprised 122 individuals with type 2 diabetes , who had access to the Internet , had completed their basic diabetes education , and had similar basic situational factors . Using a r and omization method , these participants were chosen from the patients being monitored by the diabetes nurses . The experimental group ( n = 61 ) was monitored via the Web . From measurements recorded in the sixth month of monitoring , we found that A1c levels of the individuals with diabetes who were monitored through the Web decreased ( t = 6.63 ; P and the rate of attending health check visits increased ( z = 5.97 ; P < .05 ) , while no difference was detected in the control group ( t = −0.63 ; P = .534 ; z = −0.80 ; P = .426 ) . To maintain glycemic control , Web use could be adopted as a complementary tool for monitoring individuals with diabetes",
"OBJECTIVE To assess the effect of a specialist telemedicine intervention for improving diabetes care using the chronic care model ( CCM ) . PARTICIPANTS AND METHODS As part of the CCM , 97 primary care physicians at 6 primary care practice s in Rochester , MN , referred 639 patients to an on-site diabetes educator between July 1 , 2001 , and December 31 , 2003 . On first referral , physicians were central ly r and omized to receive a telemedicine intervention ( specialty advice and evidence -based messages regarding medication management for cardiovascular risk ) or no intervention , keeping outcome assessors and data analysts blinded to group assignment . After each subsequent clinical encounter , endocrinologists review ed an abstract from the patient 's electronic medical record and provided management recommendations and supporting evidence to intervention physicians via e-mail . Control physicians received e-mail with periodic generic information about cardiovascular risk reduction in diabetes . Outcome measures included diabetes care processes ( diabetes test completion ) , outcomes ( metabolic and cardiovascular risk factors , estimated coronary artery disease risk ) , and patient costs ( payer perspective ) . RESULTS During the intervention , 951 ( 70 % ) of the 1361 endocrinology review s detected performance gaps and result ed in a message ; primary care physicians reported using 49 % of messages in patient care . With a mean of 21 months ' follow-up , the intervention , compared with control , did not significantly enhance metabolic outcomes or reduce estimated risk of coronary artery disease ( adjusted mean difference , -1 % ; 95 % confidence interval , -19 % to 17 % ) . The intervention group incurred lower costs ( P=.02 ) but not in diabetes-related costs . CONCLUSION Specialty telemedicine did not significantly enhance the value of CCM in primary care",
"PURPOSE 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",
"Aims In 2011 , we demonstrated that an individualized health management system employing advanced medical information technology , design ated ubiquitous (u)-healthcare , was helpful in achieving glycemic control without hypoglycemia in patients with diabetes . Following this , we generated a new multidisciplinary u-healthcare system by upgrading our clinical decision support system ( CDSS ) rule engine and integrating a physical activity-monitoring device and dietary feedback into a comprehensive package . Methods In a r and omized , controlled clinical trial , patients with type 2 diabetes aged over 60 years were assigned r and omly to a self-monitored blood glucose ( SMBG ) group ( N = 50 ) or u-healthcare group ( N = 50 ) for 6 months . The primary endpoint was the proportion of patients achieving glycated hemoglobin ( HbA1c ) were also investigated . The u-healthcare group was educated to use a specially design ed glucometer and an activity monitor that automatically transferred test results to a hospital-based server . An automated CDSS rule engine generated and sent patient-specific messages about glucose , diet , and physical activity to their mobile phones and a Web site . Results After 6 months of follow-up , the HbA1c level was significantly decreased in the u-healthcare group [ 8.0 ± 0.7 % ( 64.2 ± 8.8 mmol/mol ) to 7.3 ± 0.9 % ( 56.7 ± 9.9 mmol/mol ) ] compared with the SMBG group [ 8.1 ± 0.8 % ( 64.9 ± 9.1 mmol/mol ) to 7.9 ± 1.2 % ( 63.2 ± 12.3 mmol/mol ) ] ( P . The proportion of patients with HbA1c was greater in the u-healthcare group ( 26 % ) than in the SMBG group ( 12 % ; P decreased and lipid profiles improved in the u-healthcare group but not in the SMBG group . Conclusion This u-healthcare service provided effective management for older patients with type 2 diabetes ( Clinical Trial . Gov : NCT01137058 )",
"Background Diabetes outcomes are worse for underserved patients from certain ethnic/racial minority population s. Telephonic disease management is a cost-effective strategy to deliver self-management services and possibly improve diabetes outcomes for such patients . Objective We conducted a trial to test the effectiveness of a supplemental telephonic disease management program compared to usual care alone for patients with diabetes cared for in a community health center . Design R and omized controlled trial . Participants All patients had type 2 diabetes , and the majority was Hispanic or African American . Most were urban-dwelling with low socioeconomic status , and nearly all had Medicaid or were uninsured . Measurements Clinical measures included glycemic control , blood pressure , lipid levels , and body mass index . Vali date d surveys were used to measure dietary habits and physical activity . Results A total of 146 patients were r and omized to the intervention and 149 to the control group . Depressive symptoms were highly prevalent in both groups . Using an intention to treat analysis , there were no significant differences in the primary outcome ( HbA1c ) between the intervention and control groups at 12 months . There were also no significant differences for secondary clinical or behavioral outcome measures including BMI , systolic or diastolic blood pressure , LDL cholesterol , smoking , or intake of fruits and vegetables , or physical activity . Conclusions A clinic-based telephonic disease management support for underserved patients with diabetes did not improve clinical or behavioral outcomes at 1 year as compared to patients receiving usual care alone",
"OBJECTIVE Internet and other interactive technology-based programs offer great potential for practical , effective , and cost-efficient diabetes self-management ( DSM ) programs capable of reaching large numbers of patients . This study evaluated minimal and moderate support versions of an Internet-based diabetes self-management program , compared to an enhanced usual care condition . RESEARCH DESIGN AND METHODS A three-arm practical r and omized trial was conducted to evaluate minimal contact and moderate contact versions of an Internet-based diabetes self-management program , offered in English and Spanish , compared to enhanced usual care . A heterogeneous sample of 463 type 2 patients was r and omized and 82.5 % completed a 4-month follow-up . Primary outcomes were behavior changes in healthy eating , physical activity , and medication taking . Secondary outcomes included hemoglobin A1c , body mass index , lipids , and blood pressure . RESULTS The Internet-based intervention produced significantly greater improvements than the enhanced usual care condition on three of four behavioral outcomes ( effect sizes [ d ] for healthy eating = 0.32 ; fat intake = 0.28 ; physical activity= 0.19 ) in both intent-to-treat and complete-cases analyses . These changes did not translate into differential improvements in biological outcomes during the 4-month study period . Added contact did not further enhance outcomes beyond the minimal contact intervention . CONCLUSIONS The Internet intervention meets several of the RE- AIM criteria for potential public health impact , including reaching a large number of persons , and being practical , feasible , and engaging for participants , but with mixed effectiveness in improving outcomes , and consistent results across different subgroups . Additional research is needed to evaluate longer-term outcomes , enhance effectiveness and cost-effectiveness , and underst and the linkages between intervention processes and outcomes",
"Objective : There is a need for practical , efficient and broad-reaching diabetes self-management interventions that can produce changes in lifestyle behaviours such as healthy eating and weight loss . The objective of this study was to evaluate such a computer-assisted intervention . Methods : Type 2 diabetes primary care patients ( n=335 ) from fee-for-service and health maintenance organization setting s were r and omized to social cognitive theory-based tailored self-management ( TSM ) or computer-aided enhanced usual care ( UC ) . Intervention consisted of computer-assisted self-management assessment and feedback , tailored goal - setting , barrier identification , and problem-solving , followed by health counsellor interaction and follow-up calls . Outcomes were changes in dietary behaviours ( fat and fruit/vegetable intake ) , haemoglobin A1c ( HbA1c ) , lipids , weight , quality of life , and depression . Results : TSM patients reduced dietary fat intake and weight significantly more than UC patients at the 2-month follow-up . Among patients having elevated levels of HbA1c , lipids or depression at baseline , there were consistent directional trends favouring intervention , but these differences did not reach significance . The intervention proved feasible and was implemented successfully by a variety of staff . Conclusions : This relatively low-intensity intervention appealed to a large , generally representative sample of patients , was well implemented , and produced improvement in targeted behaviours . Implication s of this practical clinical trial for dissemination are discussed",
"BACKGROUND Type 2 diabetes is an individual health challenge requiring ongoing self-management . Remote patient reporting of relevant health parameters and linked automated feedback via mobile telephone have potential to strengthen self-management and improve outcomes . This research involved development and evaluation of a mobile telephone-based remote patient reporting and automated telephone feedback system , guided by health behavior change theory , aim ed at improving self-management and health status in individuals with type 2 diabetes . SUBJECTS AND METHODS This research comprised a r and omized controlled trial . Inclusion criteria were diagnosis of type 2 diabetes , elevated glycosylated hemoglobin ( HbA1c ) levels ( range , 6.5 - 11 % ) or use of oral diabetes medication , and 30 - 70 years of age . Intervention subjects ( n=24 ) participated in remote patient reporting of health status parameters and linked health behavior change feedback . Control participants ( n=24 ) received st and ard of care including diabetes education and healthcare provider counseling . Patients were followed for approximately 10 months . RESULTS Intervention participants achieved , compared with controls and controlling for baseline , a significantly greater mean reduction in HbA1c of -0.40 % ( 95 % confidence interval [ CI ] -0.67 % to -0.14 % ) versus 0.036 % ( 95 % CI -0.23 % to 0.30 % ) ( P weight reduction of -2.1 kg ( 95 % CI -3.6 to -0.6 kg ) versus 0.4 kg ( 95 % CI -1.1 to 1.9 kg ) . Nonsignificant trends for greater intervention compared with control improvement in systolic and diastolic blood pressure were observed . CONCLUSIONS Sophisticated information technology platforms for remote patient reporting linked with theory-based health behavior change automated feedback have potential to improve patient outcomes in type 2 diabetes and merit scaled-up research efforts",
"Objective To assess the effectiveness of a coach-led motivational interviewing ( MI ) intervention in improving glycaemic control , as well as clinical , psychosocial and self-care outcomes of individuals with type 2 diabetes mellitus ( T2DM ) compared with usual care . Design Pragmatic cluster r and omised controlled trial ( RCT ) . Setting Community Health Stations ( CHSs ) in Fengtai district , Beijing , China . Participants Of the 41 r and omised CHSs ( 21 intervention and 20 control ) , 21 intervention CHSs ( 372 participants ) and 18 control CHSs ( 296 participants ) started participation . Intervention Intervention participants received telephone and face-to-face MI health coaching in addition to usual care from their CHS . Control participants received usual care only . Medical fees were waived for both groups . Outcome measures Outcomes were assessed at baseline , 6 and 12 months . Primary outcome measure was glycated haemoglobin ( HbA1c ) . Secondary outcomes included a suite of anthropometric , blood pressure ( BP ) , fasting blood , psychosocial and self-care measures . Results At 12 months , no differential treatment effect was found for HbA1c ( adjusted difference 0.02 , 95 % CI −0.40 to 0.44 , p=0.929 ) , with both treatment and control groups showing significant improvements . However , two secondary outcomes : psychological distress ( adjusted difference −2.38 , 95 % CI −4.64 to −0.12 , p=0.039 ) and systolic BP ( adjusted difference −3.57 , 95 % CI −6.08 to −1.05 , p=0.005 ) were robust outcomes consistent with significant differential treatment effects , as supported in sensitivity analyses . Interestingly , in addition to HbA1c , both groups displayed significant improvements in triglycerides , LDL cholesterol and HDL cholesterol . Conclusions In line with the current Chinese primary healthcare reform , this study is the first large-scale cluster RCT to be implemented within real-world CHSs in China , specifically addressing T2DM . Although a differential treatment effect was not observed for HbA1c , numerous outcomes ( including HbA1c ) improved in both groups , supporting the establishment of regular , free clinical health checks for people with T2DM in China . Trial registration number IS RCT N01010526 ; Pre- results",
"BACKGROUND Hypertension is a major risk factor for the long-term complications of diabetes . Mobile , self-measurement of blood pressure is emerging as a method to manage blood pressure in general , but its impact in patients with diabetes is unclear . METHODS We r and omized 137 patients with diabetes and hypertension to either mobile telemonitoring ( n = 72 ) or usual care ( n = 65 ) . Clinic blood pressure was recorded at baseline and after 6 months . Patients in the intervention arm transmitted weekly blood pressure readings wirelessly , using adapted sensors via mobile phones to a central server . Clinicians received the data in real-time and using a web-based application provided management advice to the patient and their physicians . RESULTS Systolic blood pressure fell significantly in the patients in the intervention group ( mean [ 95 % confidence interval ] , -6.5 [ -0.8 to -12.2 ] mm Hg ; P = 0.027 ) and remained unchanged in the control group ( 2.1 [ 9.3 to -5.0 ] mm Hg ; P = 0.57 ) . Patients within the intervention arm of African origin seemed to benefit more from the intervention . In addition , those who achieved a systolic blood pressure of average blood sugars than those with higher readings ( 7.8 [ SD 1.6 ] vs. 8.9 [ SD 2.2 ] mmol/L ; P = 0.02 ) . CONCLUSIONS In patients with diabetes , mobile telemonitoring has potential for delivering intensified care to improve blood pressure control , and its use may be associated with reduced exposure to hyperglycemia",
"AIM This paper reports a study comparing the outcomes of diabetic patients undergoing either early discharge or routine care . BACKGROUND The hospital is not the best place to monitor the glycaemic control of patients with diabetes with no other morbidity or complications . It is an unnatural environment in which diet is planned and the activity level is low . The hospital is also an expensive place in which to treat patients . METHODS This r and omized controlled trial was conducted in the medical department of a regional hospital in Hong Kong . A total of 101 patients who needed glycaemic monitoring , but who were otherwise fit for discharge , were recruited . The control group continued to receive routine hospital care . The study group was discharged early and received a follow-up programme which included a weekly or biweekly telephone call from a nurse . FINDINGS When compared with the control group , the study group had a greater decrease in HbA1c at 24 weeks , although the statistical difference was marginal ( 7.6 vs. 8.1 , P = 0.06 ) , a higher blood monitoring adherence score at both 12 weeks ( 5.4 vs. 3.6 , P higher exercise adherence score at 12 weeks ( 5.3 vs. 3.4 , P = 0.001 ) and 24 weeks ( 5.5 vs. 3.2 , P shorter hospital stay ( 2.2 vs. 5.9 , P savings were HK$11,888 per patient . CONCLUSION It is feasible to integrate treatment into the real life environments of patients with diabetes , and nurse-led transitional care is a practical and cost-effective model . Nurse follow-up is effective in maintaining optimal glycaemic control and enhancing adherence to health behaviours . Management of glycaemic control is better done in the community than in the hospital",
"BACKGROUND The emergence of the World Wide Web in the last decade has made it feasible for the Internet to be a vehicle for chronic disease management . METHODS A r and omized controlled trial ( n = 62 ) testing the effects of a 6-month web-based intervention plus usual care , compared with usual care alone , among adults 60 years of age and older with diabetes . The outcomes were hemoglobin A1c ( HbA1c ) , blood pressure , weight , cholesterol , and high-density lipoprotein ( HDL ) levels . RESULTS A multivariate analysis of covariance controlling for all baseline outcome variables , age , gender , and number of years with diabetes showed significant ( P = 0.001 ) reductions in HbA1c , weight , and cholesterol level and significant improvement in HDL levels in the intervention versus the control group . CONCLUSIONS Findings show a web-based intervention was effective in improving HbA1c , weight , cholesterol , and HDL levels at a 6-month follow-up . Future research is needed to investigate the long-term effectiveness of web-based interventions",
"PURPOSE The present study evaluated whether an intervention using the SMS by personal cellular phone and internet would improve the levels of plasma glucose of obese type 2 diabetes at 3 , 6 , 9 , and 12 months . METHODS This is a quasi-experimental design with pre- and follow-up tests . Participants were recruited from the endocrinology outpatient department of tertiary care hospital located in an urban city of South Korea . Eighteen patients were r and omly assigned to an intervention group and 16 to a control group . The goal of the intervention was to decrease body weight and keep blood glucose concentrations close to the normal range . Patients were requested to record their blood glucose level in a weekly diary on the website by personal cellular phones or computer internet . The research er sent optimal recommendations to each patient , by both the cellular phone and the Internet weekly . The intervention was applied for 1 year . RESULTS Glycosylated hemoglobin ( HbA(1)c ) decreased 1.22 percentage points at 3 months , 1.09 percentage points at 6 months , 1.47 percentage points at 9 months , and 1.49 percentage points at 12 months compared with baseline in the intervention group ( all time points , p 2-h post-pr and ial test ( 2HPPT ) of 120.1mg/dl at 3 months , 58.9 mg/dl at 6 months , 62.0mg/dl at 9 months , and 102.9 mg/dl at 12 months compared with baseline ( all time points , p web-based intervention using SMS of personal cellular phone and Internet improved HbA(1)c and 2HPPT at 3 , 6 , 9 , and 12 months in patients with obese type 2 diabetes",
"Introduction Good metabolic control is important in type 2 diabetes mellitus to improve quality of life , work ability and life expectancy , and the use of telemedicine has proved efficient as an add-on to the usual treatment . However , few studies in type 2 diabetes patients have directly compared telemedicine with conventional outpatient treatment , and we wanted to evaluate whether telemedicine , compared with st and ard care , provides equivalent clinical outcomes . Methods Forty patients with type 2 diabetes mellitus allocated from October 2011–July 2012 were r and omized to either treatment at home by video conferences only or st and ard outpatient treatment . Primary outcomes were HbA1c and blood glucose levels and secondary outcomes were 24-hour blood pressure , cholesterol levels and albuminuria . The video-telephone was a broadb and solution installed and serviced by the Danish Telephone Company ( TDC ) . Results The improvements in the two treatments , given as changes in percentage of telemedicine vs st and ard , showed significant differences in HbA1c ( −15 vs −11 % ) , mean blood glucose ( −18 vs −13 % ) and in cholesterol ( −7 vs −6 % ) . No differences in LDL ( −4 vs −6 % ) , weight ( −1 vs 2 % ) , diastolic diurnal blood pressure ( −1 vs −7 % ) , and systolic diurnal blood pressure ( 0 vs −1 % ) were found . Nine consultations were missed in the st and ard outpatient group and none in the telemedicine group . Conclusions In the direct comparison of home video consultations vs st and ard outpatient treatment in type 2 diabetes mellitus , telemedicine was a safe and available option with favourable outcomes after six months treatment",
"A mobile phone with a glucometer integrated into the battery pack ( the ‘ Diabetes Phone ’ ) was launched in Korea in 2003 . We compared its effect on management of type 2 diabetes to the Internet-based glucose monitoring system ( IBGMS ) , which had been studied previously . We conducted a r and omized trial involving 69 patients for three months . Participants were assigned to an Internet group or a phone group . The phone group communicated with medical staff through the mobile phone only . Their glucose-monitoring data were automatically transferred to individual , web-based charts and they received medical recommendations by short message service . The Internet group used the IBGMS . There were no significant differences between the groups at baseline . After three months ' intervention , HbA1c levels of both groups had decreased significantly , from 7.6 % to 6.9 % for the Internet group and from 8.3 % to 7.1 % for the phone group ( P Levels of patient satisfaction and adherence to medical advice were similar . Mobile , bidirectional communication between doctors and patients using the diabetes phone was as effective for glucose control as the previously-studied Internet-based monitoring system and it was good for patient satisfaction and adherence",
"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",
"OBJECTIVE To determine the effect of mobile phone intervention on HbA1c in type-2 Diabetes Mellitus ( DM ) patients living in rural areas of Pakistan . STUDY DESIGN R and omized controlled trial . PLACE AND DURATION OF STUDY Department of Endocrinology , Liaquat National Hospital , Karachi , from December 2013 to June 2014 . METHODOLOGY A total of 440 patients in intervention and control groups were enrolled . All patients between 18 - 70 years of age , residing in rural areas of Pakistan , HbA1c ³ 8.0 % and having personal functional mobile phone were included . The intervention group patients were called directly on mobile phone after every 15 days for a period of 4 months . They were asked about the self-monitoring blood glucose , intake of medications , physical activity , healthy eating and were physically examined after 4 months . However , the control group was examined initially and after 4 months physically in the clinic and there were no mobile phone contacts with these patients . RESULTS Patients in intervention group showed improvement ( p 0.001 ) in following diet plan from 17.3 % at baseline to 43.6 % at endline , however , the control group showed insignificant increase ( p=0.522 ) from 13.6 % at baseline to 15.9 % at endline . Intervention group ( RR = 2.71 , 95 % CI = 1.18 - 6.40 ) showed significant positive association with normalization of HbA1c levels . The relationship was adjusted for age , gender , socio-economic status , ethnicity , education , hypertension , medication , BMI , diet , LDL levels and physical activity . Dietary restriction and low LDL levels also showed significant associations with reduced HbA1c levels on multivariate analysis . CONCLUSION Mobile phone technology in rural areas of Pakistan was helpful in lowering HbA1c levels in intervention group through direct communication with the diabetic patients . Lowering LDL and following diabetic diet plan can reduce HbA1c in these patients and help in preventing future complications",
"The Diabetes Control and Complications Trial ( DCCT ) and the Kumamoto study [ 1 , 2 ] showed that near-normal glycemic control reduces the development and progression of microvascular and neuropathic complications by approximately 50 % in type 1 and type 2 diabetes mellitus . Additional analyses [ 3 - 5 ] indicate that therapy to achieve near normalization of blood glucose levels is cost-effective compared with other treatments . Thus , the American Diabetes Association has recommended that all persons with diabetes attempt to achieve near normalization of blood glucose levels [ 6 ] . This recommendation is not routinely followed in medical practice . In a 1989 national survey of physician practice behaviors in the United States , 64 % of physicians agreed that achieving target HbA1c values is very important but only 18 % reported that they ordered HbA1c tests every 2 to 3 months for patients with type 1 diabetes [ 7 ] . Although 98 % agreed that patient education improves glucose control , only 55 % reported that they routinely used a dietitian or a diabetes educator in patient care . Studies indicate that bringing clinical practice into line with scientific knowledge can be difficult . Methods used to achieve diabetes control in clinical trials are re source intensive . The American Diabetes Association currently recommends that patients with diabetes see their primary care physicians two to four times per year . Data from the National Health Interview Survey , a nationally representative survey [ 8 ] , indicate that most patients with diabetes are seen by nonspecialists and that 69 % of physician visits last less than 15 minutes . Algorithms for diabetes care exist but may be complex and difficult for physicians to follow , given patient load , diversity of patients seen , lack of information systems , and time constraints . Simple , low-cost methods of translating guidelines into clinical care are required . One solution may be to make greater use of personnel other than physicians . Nurse case management was an integral part of intensive therapy in the DCCT and has proven to be effective in reducing smoking and cholesterol levels after acute myocardial infa rct ion [ 3 , 9 ] . A nonr and omized study [ 10 ] of more than 700 patients with diabetes in a health maintenance organization suggests that nurse case management may be effective in improving metabolic control . Other studies [ 11 , 12 ] show a strong association between algorithm-directed nurse interventions and improved glycemic control . To our knowledge , no r and omized , controlled clinical trial of nurse case management in diabetes has yet been published . In a 12-month r and omized , controlled trial , we compared a nurse case management model of diabetes care with usual diabetes management in a primary care setting . Methods Patients Our study was approved by the institutional review board of the Prudential Center for Health Care Research , and all patients gave written informed consent . Participants were recruited from two of the largest clinics within the Jacksonville Health Care Group , which is the largest provider of primary care services for the Prudential HealthCare HMO plan of Jacksonville , Florida . The Jacksonville Health Care Group is a group of 43 primary care physicians who provide care in eight clinics to more than 75 000 Prudential HealthCare plan members . Potential study participants were identified through a data base used to support quality -improvement activities . Prudential HealthCare HMO members who had diabetes were included in the data base if they had visited a physician for diabetes ( International Classification of Diseases , 9th Revision , codes 250.0 to 250.9 ) , had had a hospital cl aim processed for diabetes , had been seen by the utilization management nurse , or had been referred to an ophthalmologist for a diabetic retinal examination . This data base is up date d regularly . A list with each member 's name , address , telephone number , medical record number , member identification number , age , sex , physician , and clinic was generated by merging the data from the data base with enrollment information . In addition , a list of members who may have had diabetes was created by using pharmacy data . Adult members with diabetes who were potential study participants each received a recruitment call and were invited to schedule an appointment with a research assistant to discuss participation in the study . We made a total of 14 calls at different times and on different days before coding a member as unavailable . After consent was given and the eligibility assessment was completed , baseline information was obtained and an HbA1c test was ordered if the result of one given within the previous 60 days was not available . Patients were ineligible for the study if they had a recent HbA1c value less than 7.0 % ; had uncontrolled hypertension ( blood pressure > 180/110 mm Hg ) ; had unstable angina ( class 4 ) ; had had a myocardial infa rct ion in the past 3 months ; had had two or more episodes of seizures ; had alcoholism or drug abuse documented in the chart ; had late-stage complications of diabetes or other chronic conditions , such as severe immunodeficiency or cirrhosis ; were pregnant or were planning to become pregnant in the next 12 months ; or were unable to perform self-management . Patients were r and omly assigned in blocks to either the nurse case management ( intervention ) group or the usual care group . R and omization was based on a 1:1 allocation ratio and a block size of three . Each block contained six patients , three in each study group . This r and omization scheme ensured that the desired allocation ratio-one intervention patient to one usual care patient-was maintained after sequential enrollment of every sixth patient . Outcome Measures Change in HbA1c value was the primary outcome measure . Decreased HbA1c values correlate directly with reduced risk for diabetes-related microvascular and neuropathic complications in type 1 and type 2 diabetes [ 1 , 3 ] . We also assessed health-related quality of life by using four generic questions developed by the Centers for Disease Control and Prevention for the Behavioral Risk Factor Surveillance System ( BRFSS ) [ 13 , 14 ] . These questions evaluate key conceptual domains of health-related quality of life : 1 ) patient-perceived general health status , 2 ) patient-perceived physical dysfunction during the previous 30 days , 3 ) patient-perceived mental dysfunction during the previous 30 days , and 4 ) patient-perceived functional incapacity during the previous 30 days for either mental or physical reasons . The BRFSS quality -of-life measures have been vali date d in a national sample of adults in the United States [ 15 ] . Patient-perceived health was found to be a good proxy indicator for chronic disease conditions . The other three domains further characterize general health functioning and quality of life [ 15 ] . In this analysis , we report findings related to the patient-perceived general health status domain . Intervention and Follow-up The nurse case manager was a registered nurse and a certified diabetes educator . She was trained to follow a set of detailed management algorithms under the direction of a board-certified family medicine physician and an endocrinologist who were responsible for all diabetes management decisions for patients in the intervention group but were not primary care providers for these patients . The algorithms were specific for type of diabetes and were developed by a multidisciplinary team on which endocrinology , family medicine , nursing , pharmacy , health services research , and epidemiology were represented . The algorithms progressively moved a patient toward improvement of glycemic control through adjustments in medication , meal planning , and reinforcement of exercise ( Figure 1 ) . Figure 1 . Algorithm for management of type 2 diabetes mellitus . Patients assigned to receive nurse case management met with the nurse for an initial assessment , were instructed about a blood glucose monitoring schedule , and returned for a follow-up visit 2 weeks later . The initial visit with the nurse averaged 45 minutes . At the 2-week follow-up visit , the nurse review ed the patient 's blood glucose log ; explained the algorithm step to which the patient had been assigned ; and used this information as the baseline for subsequent medication adjustments , meal planning , and exercise reinforcement . Patients receiving nurse case management were also referred to a 5-week , 12-hour diabetes education program that included individual counseling by a dietitian , individual counseling by an exercise therapist , and group diabetes education classes . Subsequent in-person follow-up visits occurred quarterly . Patients in the nurse case management group who were taking insulin received weekly follow-up telephone calls . After the nurse review ed the blood glucose log and discussed glucose values with the patient , medication regimens were adjusted as needed and meal planning and exercise were reinforced . Patients treated with oral agents or diet and exercise received follow-up telephone calls every 2 weeks . The nurse case manager met at least biweekly with the family medicine physician and the endocrinologist to review patient progress , medication adjustments , and other issues related to diabetes care . All medication adjustments or changes were communicated to the patients ' regular primary care physicians . Patients assigned to receive usual care were given blood glucose meters and strips , were encouraged to discuss enrollment in the diabetes education class with their physicians if they had not done so in the past year , and continued to receive diabetes care and follow-up from their primary care physicians . The 5-week diabetes education program is a st and ard , free-of-charge benefit for all HMO members with diabetes . All Jacksonville Health Care Group primary care physicians participate in an annual diabetes care seminar and undergo regular peer review of their adherence to published diabetes care st and ards . Tests to",
"AIM The objective of the current study is to assess the effectiveness of Mobile Short Message Service ( SMS ) intervention on education of basic self-care skills in patients with type 2 diabetes . Moreover , we aim ed to determine whether delivering individually-tailored educational messages can be more effective than general educational messages . METHODS A total of 150 patients with diabetes type 2 were r and omized into three groups : tailored SMS group , non-tailored SMS group , and the control group . Biochemical parameters including HbA1c , FBS , lipid profile were evaluated for the three groups at baseline and after 12 weeks . Moreover , self-care Inventory ( SCI ) , Diabetes Management Self-Efficacy Scale ( DMSES ) and Diabetes Self-Care Barriers assessment scale for Older Adults ( DSCB-OA ) were completed . In the tailored SMS group , each person received 75 % of their messages based on the top two barriers to adherence that they had experienced and reported in their scale . In the non-tailored SMS group , r and om messages were sent to every patient . RESULTS After 12 weeks , although HgA1c levels did not significantly change , significant decline was observed in FBS and mean BMI in both intervention groups . Mean SCI-R scores significantly increased and mean DSCB and DMSES scores significantly decreased in both tailored and non-tailored SMS groups . In the control group , mean SCI-R scores decreased and mean DSCB and DMSES scores significantly increased ( P short text messages as a method of education in conjunction with conventional diabetes treatment can improve glycemic control and positively influence other aspects of diabetes self-care . According to our findings , sending SMS regularly in particular times appears to be as effective as sending individually tailored messages",
"Background : Telehealth-supported clinical interventions may improve diabetes self-management . We explored the feasibility of stepwise self-titration of oral glucose-lowering medication guided by a mobile telephone-based telehealth platform for improving glycemic control in type 2 diabetes . Methods : We recruited 14 type 2 diabetes patients to a one-year feasibility study with 1:1 r and omization . Intervention group patients followed a stepwise treatment plan for titration of oral glucose-lowering medication with self-monitoring of glycemia using real-time graphical feedback on a mobile telephone and remote nurse monitoring using a Web-based tool . We carried out an interim analysis at 6 months . Results : We screened 3476 type 2 diabetes patients ; 94 % of the ineligible did not meet the eligibility criteria for hemoglobin A1c ( HbA1c ) or current treatment . Mean ( st and ard deviation ) patient age at baseline was 58 ( 11 ) years , HbA1c was 65 ( 12 ) mmol/mol ( 8.1 % [ 1.1 % ] ) , body mass index was 32.9 ( 6.4 ) kg/m2 , median [ interquartile range ( IQR ) ] diabetes duration was 2.6 ( 0.6 to 4.7 ) years , and 10 ( 71 % ) were men . The median ( IQR ) change in HbA1c from baseline to six months was −10 ( −21 to 3 ) mmol/mol ( −0.9 % [ -1.9 % to 0 % ] ) in the intervention group and −5 ( −13 to 6 ) mmol/mol ( −0.5 % [ -1.2 % to 0.6 % ] ) in the control group . Six out of seven intervention group patients and four out of seven control group patients changed their oral glucose-lowering medication ( p = .24 ) . Conclusions : Self-titration of oral glucose-lowering medication in type 2 diabetes with self-monitoring and remote monitoring of glycemia is feasible , and further studies using adapted recruitment strategies are required to evaluate whether it improves clinical outcomes ",
"Brief , cost-effective interventions to promote diabetes self-management are needed . This study evaluated the effects of a brief , regular , proactive , telephone “ coaching ” intervention delivered by paraprofessionals on diabetes adherence , glycemic control , diabetes-related medical symptoms , and depressive symptoms . Therapeutic mechanisms underlying the intervention ’s effect on the primary outcomes were also examined . Adults diagnosed with type 2 diabetes ( N = 62 ) were r and omly assigned to receive the “ coaching ” intervention and treatment as usual , or only treatment as usual . The intervention increased frequency of exercise and feet inspection , improved diet , reduced diabetes medical symptoms , and lowered depressive symptoms . Self-efficacy , reinforcement , and awareness of self-care goals mediated the treatment effect on depression , exercise , and feet inspection , respectively . A brief telephone intervention delivered by paraprofessionals had positive effects on type 2 diabetes patients",
"Background : This study examined whether mobile phone-based , one-way video messages about diabetes self-care improve hemoglobin A1c ( A1C ) and self-monitoring of blood glucose ( SMBG ) . Methods : This was a 1-year prospect i ve r and omized trial with two groups . The active intervention lasted 6 months . The study enrolled 65 people with A1C > 8.0 % who were established ( > 6 months ) patients in the endocrinology clinics of the Walter Reed Health Care System . Participants were r and omized to receive “ usual care ” or self-care video messages from their diabetes nurse practitioner . Video messages were sent daily to cell phones of study participants . Hemoglobin A1c and SMBG data were collected at 0 , 3 , 6 , 9 , and 12 months . Results : Participants who received the messages had a larger rate of decline in A1C than people who received usual care ( 0.2 % difference over 12 months , adjusting for covariates ; p = .002 and p = .004 for the interaction between time and group and for the quadratic effect of time by group , respectively ) . Hemoglobin A1c decline was greatest among participants who received video messages and viewed > 10 a month ( 0.6 % difference over 12 months , adjusting for covariates ; p Self-monitoring of blood glucose metrics were not related to the intervention . Conclusions : A one-way intervention using mobile phone-based video messages about diabetes self-care can improve A1C . Engagement with the technology is an important predictor of its success . This intervention is simple to implement and sustain",
"Background Adoptions of health behaviors are crucial for maintaining good health after type 2 diabetes mellitus ( T2DM ) diagnoses . However , adherence to glucoregulating behaviors like regular exercise and balanced diet can be challenging , especially for people living in lower-socioeconomic status ( SES ) communities . Providing cost-effective interventions that improve self-management is important for improving quality of life and the sustainability of health care systems . Objective To evaluate a health coach intervention with and without the use of mobile phones to support health behavior change in patients with type 2 diabetes . Methods In this noninferiority , pragmatic r and omized controlled trial ( RCT ) , patients from two primary care health centers in Toronto , Canada , with type 2 diabetes and a glycated hemoglobin/hemoglobin A1c ( HbA1c ) level of ≥7.3 % ( 56.3 mmol/mol ) were r and omized to receive 6 months of health coaching with or without mobile phone monitoring support . We hypothesized that both approaches would result in significant HbA1c reductions , although health coaching with mobile phone monitoring would result in significantly larger effects . Participants were evaluated at baseline , 3 months , and 6 months . The primary outcome was the change in HbA1c from baseline to 6 months ( difference between and within groups ) . Other outcomes included weight , waist circumference , body mass index ( BMI ) , satisfaction with life , depression and anxiety ( Hospital Anxiety and Depression Scale [ HADS ] ) , positive and negative affect ( Positive and Negative Affect Schedule [ PANAS ] ) , and quality of life ( Short Form Health Survey-12 [ SF-12 ] ) . Results A total of 138 patients were r and omized and 7 were excluded for a sub study ; of the remaining 131 , 67 were allocated to the intervention group and 64 to the control group . Primary outcome data were available for 97 participants ( 74.0 % ) . While both groups reduced their HbA1c levels , there were no significant between-group differences in change of HbA1c at 6 months using intention-to-treat ( last observation carried forward [ LOCF ] ) ( P=.48 ) or per- protocol ( P=.83 ) principles . However , the intervention group did achieve an accelerated HbA1c reduction , leading to a significant between-group difference at 3 months ( P=.03 ) . This difference was reduced at the 6-month follow-up as the control group continued to improve , achieving a reduction of 0.81 % ( 8.9 mmol/mol ) ( P=.001 ) compared with a reduction of 0.84 % ( 9.2 mmol/mol)(P=.001 ) in the intervention group . Intervention group participants also had significant decreases in weight ( P=.006 ) and waist circumference ( P=.01 ) while controls did not . Both groups reported improvements in mood , satisfaction with life , and quality of life . Conclusions Health coaching with and without access to mobile technology appeared to improve glucoregulation and mental health in a lower-SES , T2DM population . The accelerated improvement in the mobile phone group suggests the connectivity provided may more quickly improve adoption and adherence to health behaviors within a clinical diabetes management program . Overall , health coaching in primary care appears to lead to significant benefits for patients from lower-SES communities with poorly controlled type 2 diabetes . Trial Registration Clinical Trials.gov NCT02036892 ; http:// clinical trials.gov/ct2/show/NCT02036892 ( Archived by WebCite at http://www.webcitation.org/6b3cJYJOD",
"AIMS Care management may improve the quality of diabetes care by enhancing contact between high-risk patients and their providers . This prospect i ve , longitudinal , r and omized trial sought to investigate whether telephone or online care management improves diabetes-related outcomes over time compared with usual care supplemented with Internet access and training . SUBJECTS AND METHODS One hundred fifty-one adult subjects with type 2 diabetes mellitus and an elevated hemoglobin A1c ( A1c ) level ( ≥8.5 % ) were r and omly assigned to online care management ( n=51 ) , telephone-based care management ( n=51 ) , or Web training ( n=49 ) groups . Online and telephone participants interacted with a care manager through a diabetes education and care management Web site and by telephone , respectively . The Web training group was provided with online diabetes self-management re sources but no care management support . The primary outcome measure was A1c measured every 3 months for a year . RESULTS A1c declined significantly and substantially in all groups over 12 months . A1c declined linearly at a rate of 0.32 % ( P average absolute A1c difference of -1.5 % . The number of interactions with care providers was not significantly associated with the change in A1c . Blood pressure , weight , lipid levels , and diabetes distress did not differ among groups over time . CONCLUSIONS Online , telephone-based care management , and Web training for diabetes patients with elevated A1c were each associated with a substantial improvement in A1c over a 1-year period . Internet access and training alone may be as effective as care management in patients with poorly controlled diabetes",
"PURPOSE We sought to evaluate the effect of automated telephone assessment and self-care education calls with nurse follow-up on the management of diabetes . SUBJECTS AND METHODS We enrolled 280 English- or Spanish-speaking adults with diabetes who were using hypoglycemic medications and who were treated in a county health care system . Patients were r and omly assigned to usual care or to receive an intervention that consisted of usual care plus bi-weekly automated assessment and self-care education calls with telephone follow-up by a nurse educator . Outcomes measured at 12 months included survey-reported self-care , perceived glycemic control , and symptoms , as well as glycosylated hemoglobin ( Hb A1c ) and serum glucose levels . RESULTS We collected follow-up data for 89 % of enrollees ( 248 patients ) . Compared with usual care patients , intervention patients reported more frequent glucose monitoring , foot inspection , and weight monitoring , and fewer problems with medication adherence ( all P -0.03 ) . Follow-up Hb A , , levels were 0.3 % lower in the intervention group ( P = 0.1 ) , and about twice as many intervention patients had Hb A1c levels within the normal range ( P = 0.04 ) . Serum glucose levels were 41 mg/dL lower among intervention patients than usual care patients ( P = 0.002 ) . Intervention patients also reported better glycemic control ( P = 0.005 ) and fewer diabetic symptoms ( P symptoms of hyperglycemia and hypoglycemia . CONCLUSIONS Automated calls with telephone nurse follow-up may be an effective strategy for improving self-care behavior and glycemic control , and for decreasing symptoms among vulnerable patients with diabetes",
"BACKGROUND 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",
"BACKGROUND Telemedicine is one approach to managing patients with chronic illness . Several telephone-based monitoring studies of diabetes patients have shown improved glycosylated hemoglobin ( HbA1c ) , blood pressure ( BP ) , and low-density lipoprotein ( LDL ) levels . The purpose of this study was to evaluate an investigational in-home telemetry device for improving glucose and BP control over 6 months for patients with type 2 diabetes . The device was used to transmit weekly blood glucose , weight , and BP readings to a diabetes care manager . SUBJECTS AND METHODS We conducted a two-arm , parallel-comparison , single-blind , r and omized controlled trial among Kaiser Permanente Northern California members 18 - 75 years old with type 2 diabetes mellitus and entry HbA1c levels between 7.5 % and 10.0 % . Participants were r and omly assigned to either the telemonitoring arm or the usual care arm . RESULTS We observed very small , nonsignificant changes in fructosamine ( telemonitoring , -54.9 μmol ; usual care , -59.4 μmol ) and systolic BP ( telemonitoring , -6.3 mm Hg ; usual care , -3.2 mm Hg ) from baseline to 6 weeks in both groups . At 6 months , we observed no significant intergroup differences in change from baseline for HbA1c , fructosamine , or self-efficacy . However , LDL cholesterol in the telemonitoring arm decreased more than in the usual care arm ( -17.1 mg/dL versus -5.4 mg/dL ; P=0.045 ) . CONCLUSIONS Although HbA1c improved significantly over 6 months in both groups , the difference in improvement between the groups was not significant . This lack of significance may be due to the relatively healthy status of the volunteers in our study and to the high level of care provided by the care managers in the Santa Rosa , CA clinic . Further study in subgroups of less healthy diabetes patients is recommended",
"RATIONALE , AIMS AND OBJECTIVES Utilizing information technology , such as Internet and cellphones , holds great promise in enhancing diabetic care . Yet few studies have examined the impact of cellphone technology on type 2 diabetics ' self-care . The primary aim of the study is to examine the feasibility of utilizing this technology to assist with diabetes self-care in a clinic population as well as its impact on clinical outcomes . METHODS Thirty patients with a diagnosis of type 2 diabetes at two Community Health Centers were r and omized to intervention or control . Intervention patients participated in a brief intervention and received tailored daily messages via cellphone prompting them to enhance their diabetic self-care behaviour . Patients at the control site continued with their st and ard diabetes self-management . RESULTS A mean improvement in HbA1c levels was apparent ( -0.1 , SD = 0.3 % ; P = 0.1534 ) in the intervention group , compared with a mean deterioration in the control ( 0.3 , SD = 1.0 % ; P = 0.3813 ) , yet without statistical significance . Self-efficacy scores improved significantly in the intervention group ( -0.5 , SD = 0.6 ; P = 0.0080 ) compared with no improvement in the control ( 0.0 , SD = 1.0 ; P = 0.9060 ) . Participants encountered numerous technological barriers when attempting to adhere to the intervention protocol . CONCLUSION The results indicate the intervention had a positive impact on some clinical outcome and self-efficacy . Although the technology appears feasible in a clinical setting technology must be made more user-friendly before a larger phase II trial is conducted",
"AIM To determine whether a nurse telephone follow-up service could improve the level of adherence to a diabetes therapeutic regimen for patients with type 2 diabetes . METHODS A total of 61 patients attended a 3 day diabetes self-care program at the Iranian Diabetes Society . They were r and omly assigned to one of the experimental or control groups . A telephone follow-up program was applied to the experimental group for 3 months , twice per week for the first month and weekly for the second and third months . The data - collection instruments included a data sheet to record the glycosylated hemoglobin ( HbA1c ) level and a question naire . The data were collected at baseline and after 12 weeks . RESULTS There were significant differences between the control and the experimental groups in their adherence to a diabetic diet , exercise , foot care , blood glucose monitoring , and medication-taking . Also , the HbA1c levels differed significantly between the two groups after 3 months . CONCLUSION A nurse-led telephone follow-up was effective in enhancing the level of adherence to a diabetes therapeutic regimen , such that the HbA1c level decreased",
"PURPOSE To develop and evaluate a Web-based , patient-orientated diabetic education management ( POEM ) system . METHODS The POEM system has been developed to extend hospital patient education by integrating patients ' medical care data into their education program components and presenting them on the Web . Since most patients are concerned about their medical care data , the POEM system can provide the incentives for patients to continuously and persistently log in and learn the required knowledge and skills , improving their clinical outcomes . A quasi-experimental method that uses control groups and pretests was used to evaluate the outcomes of the system intervention . We recruited patients with type-2 diabetes and alternatively assigned them to intervention and control groups . We compared laboratory test results including fasting blood glucose , HbA1c , total cholesterol , triglyceride ( TG ) , and HDL between the two groups from the first visit through each follow-up visit . The study period progressed from September 2003 to May 2004 at the Metabolism Center of a medical teaching hospital in Taipei . RESULTS In this study , we recruited 274 participants : 134 ( 57 % males and 43 % females ) in the intervention group and 140 ( 46 % males and 54 % females ) in the control group . The patients ' laboratory test results from the first visit for fasting blood glucose , HbA1c , total cholesterol level , TG , and HDL in the intervention and control groups were respectively 187.54+/-77.10 and 189.99+/-73.49 mg/dl , 9.03 + /- 2.79 % and 8.95 + /- 2.23 % , 193.29 + /- 47.93 and 202.52 + /- 58.45 mg/dl , 152.48 + /- 70.85 and 157.37 + /- 74.88 mg/dl , and 44.97 + /- 12.09 and 45.32 + /- 12.08 mg/dl . There were three follow-up visits during the study period . We collected laboratory test results of the two groups through each of the following visits and analyzed them using ANCOVA . We discovered a significant difference in fasting blood glucose levels between intervention and control group as early as the first follow-up . At the second follow-up , both fasting blood glucose and HBA1c levels were significantly different between intervention and control group . At the third follow-up , there was a significant difference in fasting blood glucose , HBA1c , and total cholesterol between intervention and control group . We also monitored the number of logins for the patients in the intervention group during the follow-up period . The result showed the patients had consistently logged into the POEM system ( about 8.5 + /- 3.7 logins per person per month after 3 months enrollment ) . Thus , the patients in the intervention group had better control of their fasting blood glucose , HbA1c and total cholesterol levels than those in the control group due to the assistance of the system . CONCLUSIONS The POEM system can help patients control their glucose , HbA1c and total cholesterol levels to manage their diabetes , providing an easy and inexpensive way to extend hospital-based patient education services for community-based continuous patient education",
"BACKGROUND Increased emphasis is being placed on the critical need to control hypertension ( HTN ) in patients with diabetes . OBJECTIVE The objective of this study was to evaluate the efficacy of a nurse-managed home telehealth intervention to improve outcomes in veterans with comorbid diabetes and HTN . DESIGN A single-center , r and omized , controlled clinical trial design comparing two remote monitoring intensity levels and usual care in patients with type 2 diabetes and HTN being treated in primary care was used . MEASUREMENTS Primary outcomes were hemoglobin A1c and systolic blood pressure ( SBP ) ; secondary outcome was adherence . RESULTS Intervention subjects experienced decreased A1c during the 6-month intervention period compared with the control group , but 6 months after the intervention was withdrawn , the intervention groups were comparable with the control group . For SBP , the high-intensity subjects had a significant decrease in SBP compared with the other groups at 6 months and this pattern was maintained at 12 months . Adherence improved over time for all groups , but there were no differences among the three groups . LIMITATIONS Subjects had relatively good baseline control for A1c and SBP ; minorities and women were underrepresented . CONCLUSIONS Home telehealth provides an innovative and pragmatic approach to enhance earlier detection of key clinical symptoms requiring intervention . Transmission of education and advice to the patient on an ongoing basis with close surveillance by nurses can improve clinical outcomes in patients with comorbid chronic illness",
"The objective of this study was to evaluate the value of an intensive telephone follow-up as an additional component of a diabetes disease management program already shown to be effective in improving glycemic control , adherence with American Diabetes Association ( ADA ) st and ards of care , and health-related quality of life ( HRQOL ) . The study involved a r and omized controlled trial . The intervention group received a series of 12 weekly phone calls reinforcing base education and self-management skills . Five hundred and seven consenting patients , age 18 years or older , with type 1 or type 2 diabetes mellitus referred to the hospital- based disease management program who had telephones and were able to complete surveys in English or Spanish were enrolled . Outcomes were evaluated at 3 and 12 months follow- up . Adherence to ADA st and ards of care , specifically annual eye exams , physician foot exams , foot self-exams , and pneumonia vaccination were significantly better with the added telephone intervention , but there were no differences between the groups on glycemic control , HRQOL , or patient satisfaction . The effectiveness of the disease management program was replicated with sustained improvement in glycemic control , HRQOL , and adherence to ADA st and ards . The additional telephone intervention further improved adherence to ADA guidelines for self-care and medical care but did not affect glycemic control or HRQOL",
"This study was performed to investigate the effect of a telephone-delivered intervention on glycemic control and body mass index in Korean type 2 diabetic patients . 38 patients were r and omly selected , with 20 assigned to a telephone group and 18 to a control group . The goal of the intervention was to keep blood glucose concentrations close to the normal range . The intervention was applied to the telephone group for 12 weeks . It consisted of continuous education and reinforcement of diet , exercise and medication adjustment , as well as frequent self-monitoring of blood glucose levels . Telephone intervention was performed twice per week for the first month , and then weekly for the second and third months . Subjects were requested to write self- management logs , including blood glucose , diet and an exercise diary . The diet diaries were analyzed by a dietitian , and subjects instructed about the results by telephone counseling or mail . All medication adjustments were communicated to the subjects ' diabetes specialist . Glycosylated hemoglobin ( HbA1c ) , fasting blood glucose ( FBG ) and 2-hour postpr and ial glucose were measured before , and after , the intervention . Patients in the telephone group had a mean decrease of 1.2 % , with those in the control group having a mean increase of 0.6 % , in HbA1c . There were no significant differences in the body mass index ( BMI ) between the two groups . These findings indicated that a telephone-delivered intervention would improve HbA1c , but would not affect BMI",
"IMPORTANCE In type 2 diabetes mellitus ( T2DM ) , team management using protocol s with regular feedback improves clinical outcomes , although suboptimal self-management and psychological distress remain significant challenges . OBJECTIVE To investigate if frequent contacts through a telephone-based peer support program ( Peer Support , Empowerment , and Remote Communication Linked by Information Technology [ PEARL ] ) would improve cardiometabolic risk and health outcomes by enhancing psychological well-being and self-care in patients receiving integrated care implemented through a web-based multicomponent quality improvement program ( JADE [ Joint Asia Diabetes Evaluation ] ) . DESIGN , SETTING , AND PARTICIPANTS Between 2009 and 2010 , 628 of 2766 Hong Kong Chinese patients with T2DM from 3 publicly funded hospital-based diabetes centers were r and omized to the JADE + PEARL ( n = 312 ) or JADE ( n = 316 ) groups , with comprehensive assessment at 0 and 12 months . INTERVENTIONS Thirty-three motivated patients with well-controlled T2DM received 32 hours of training ( four 8-hour workshops ) to become peer supporters , with 10 patients assigned to each . Peer supporters called their peers at least 12 times , guided by a checklist . MAIN OUTCOMES AND MEASURES Changes in hemoglobin A(1c ) ( HbA(1c ) ) level ( primary ) , proportions of patients with attained treatment targets ( HbA(1c ) blood pressure mm Hg ; low-density lipoprotein cholesterol mmol/L [ to convert to milligrams per deciliter , divide by 0.0256 ] ) ( secondary ) , and other health outcomes at month 12 . RESULTS Both groups had similar baseline characteristics ( mean [ SD ] age , 54.7 [ 9.3 ] years ; 57 % men ; disease duration , 9.4 [ 7.7 ] years ; HbA(1c ) level , 8.2 % [ 1.6 % ] ; systolic blood pressure , 136 [ 19 ] mm Hg ; low-density lipoprotein cholesterol level , 2.89 [ 0.82 ] mmol/L ; 17.4 % cardiovascular-renal complications ; and 34.9 % insulin treated ) . After a mean ( SD ) follow-up period of 414 ( 55 ) days , 5 patients had died , 144 had at least 1 hospitalization , and 586 had repeated comprehensive assessment s. On intention-to-treat analysis , both groups had similar reductions in HbA(1c ) ( JADE + PEARL , 0.30 % [ 95 % CI , 0.12%-0.47 % ] , vs JADE , 0.29 % [ 95 % CI , 0.12%-0.47 % ] [ P = .97 ] ) and improvements in treatment targets and psychological-behavioral measures . In the JADE + PEARL group , 90 % of patients maintained contacts with their peer supporters , with a median of 20 calls per patient . Most of the discussion items were related to self-management . CONCLUSIONS AND RELEVANCE In patients with T2DM receiving integrated care , peer support did not improve cardiometabolic risks or psychological well-being . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00950716",
"PURPOSE The purpose of this pilot study was to determine the efficacy of a 6-month nurse-coaching intervention that was provided after diabetes education for women with type 2 diabetes . METHODS In this pilot study , 53 women were r and omized to the nurse-coaching intervention or a st and ard care control condition . The nurse-coaching intervention consisted of 5 individualized sessions and 2 follow-up phone calls over 6 months . The nurse-coaching sessions included educational , behavioral , and affective strategies . Data were collected on physiologic adaptation ( hemoglobin A1c [ A1C ] and body mass index [ BMI ] ) , self-management ( dietary and exercise ) , psychosocial adaptation ( diabetes-related distress and integration ) , and treatment satisfaction at baseline , 3 months , and 6 months . RESULTS Women in the treatment group demonstrated better diet self-management , less diabetes-related distress , better integration , and more satisfaction with care , and had trends of better exercise self-management and BMI . The A1C levels improved in both groups at 3 months , yet the difference between the groups was not significant . Attendance at nurse-coaching sessions was 96 % . CONCLUSIONS This nurse-coaching intervention demonstrates promise as a means of improving self-management and psychosocial outcomes in women with type 2 diabetes",
"Effective control of diabetes is known to delay or prevent the end-organ complications of this disease . Can telemedicine improve a patient 's ability to self-manage diabetes ? Twenty-eight patients entered a study comparing home telemedicine consultation with st and ard outpatient care . A nurse case manager contacted the telemedicine group once a week under the direction of a primary care physician , who contacted the telemedicine group once a month . Laboratory studies and total body weight were measured at the beginning and at the end of the 3-month study . The hemoglobin A1c ( HbA1c ) and total body weight improved significantly in the intervention ( telemedicine ) group , as shown by a 16 % reduction in mean HbA1c level ( from 9.5 to 8.2 % ) and a 4 % mean weight reduction ( from 214.3 to 206.7 pounds ) . Based on our experience , we present a functionally based telemedicine classification system to improve the application of electronic medicine in future studies",
"AIMS To evaluate the feasibility and effectiveness of a telemedicine system based on internet in the follow-up of patients with type 2 diabetes mellitus ( T2DM ) . METHODS A prospect i ve r and omized telemedicine study with two parallel groups was design ed . 114 patients diagnosed T2DM were r and omly divided into telemedicine group and traditional face-to-face visit group as control . 57 cases were included for each group . 108 patients completed the trial , in which 53 cases in telemedicine group and 55 cases in control group . Patients in telemedicine group were taught to use telemedicine software to upload their blood glucose and other metabolic information at home at least every 2 weeks , and the research ers gave proper advices according to patients ' key behaviors . The telemedicine interval is 3 months . RESULTS Compared to control group , telemedicine group exhibited better HbA1c and fasting blood glucose controlling ( P decreased hypoglycemia risk ( P = 0.044 ) , and contributed to levels of HbA1c less than 7 % which is the target of our study ( P = 0.049 ) . CONCLUSIONS Telemedicine system can provide a tighter glycemic control for the treatment of T2DM patients , especially in cases with difficulties to access to the medical centre",
"BACKGROUND Aggressive management of blood glucose reduces future diabetes-related complications , but this is difficult to achieve . METHODS This r and omized , controlled study tested the effect of using a wireless two-way pager-based automated messaging system to improve diabetes control through facilitated self-management . The system sent health-related messages to patients , with automatic forwarding of urgent patient responses to the health care team . RESULTS Participants in both the experimental ( pager ) and the control groups experienced an average hemoglobin A1c decrease of 0.1 - 0.3 % . More patients in the pager group were normotensive , and more felt that their health care was better by the end of the study . A total of 79 % of participants enjoyed using the pager , and 68 % wanted to continue using the system . CONCLUSIONS Utilizing a wireless , automated messaging system in clinical practice is a feasible , low-cost , interactive way to facilitate diabetes self-management , which is acceptable to patients . While providing a convenient way for patients and providers to communicate , this system can support automated recording and ready retrieval of these real-time interactions",
"We determined the impact of a remote blood glucose telemonitoring program with feedback in type 2 diabetes mellitus patients fasting during Ramadan compared to conventional self-monitoring method . A twelve-week cluster r and omised study , with 85 participants who wish to fast for at least 15 days during Ramadan was conducted . Self-measurement and transmission of blood glucose results were performed six times daily during Ramadan . Results were transmitted to a secure website for review with feedback from case manager if necessary . The control group received usual care . The main outcome was the number of participants experiencing hypoglycaemia during Ramadan and at the end of the study . During Ramadan , the number of participants reporting hypoglycaemia was significantly lower in the telemonitoring group [ Odds ratio ( OR ) : 0.186 , 95 % confidence interval : 0.04–0.936 ; p = 0.04 ] . Similarly , the proportion of participants reporting symptomatic hypoglycaemia at the end of the study was significantly lower in the telemonitoring group ( OR : 0.257 , 95 % CI : 0.07–0.89 ; p = 0.03 ) . A reduction of 1.07 % in glycated haemoglobin levels was observed in the telemonitoring group compared to 0.24 % in the control group ( p < 0.01 ) . Overall , telemonitoring was a useful adjunct to reduce the risk of hypoglycaemia during Ramadan with no deterioration in glycaemic",
"OBJECTIVE To determine whether Pro-Active Call Center Treatment Support ( PACCTS ) , using trained nonmedical telephonists supported by specially design ed software and a diabetes nurse , can effectively improve glycemic control in type 2 diabetes . RESEARCH DESIGN AND METHODS A r and omized controlled implementation trial of 1-year duration was conducted in Salford , U.K. The trial comprised 591 r and omly selected individuals with type 2 diabetes . By r and om allocation , 197 individuals were assigned to the usual care ( control ) group and 394 to the PACCTS ( intervention ) group . Lifestyle advice and drug treatment in both groups followed local guidelines . PACCTS patients were telephoned according to a protocol with the frequency of calls proportional to the last HbA(1c ) level . The primary outcome was absolute reduction in HbA(1c ) , and the secondary outcome was the proportion of patients reducing HbA(1c ) by at least 1 % . RESULTS A total of 332 patients ( 84 % ) in the PACCTS group and 176 patients ( 89 % ) in the control group completed the study . Final HbA(1c ) values were available in 374 patients ( 95 % ) in the PACCTS group and 180 patients ( 92 % ) in the usual care group . Compared with usual care , HbA(1c ) improved by 0.31 % ( 95 % CI 0.11 - 0.52 , P = 0.003 ) overall in the PACCTS patients . For patients with baseline HbA(1c ) > 7 % , the improvement increased to 0.49 % ( 0.21 - 0.77 , P achieving a > /=1 % reduction in HbA(1c ) significantly favored the PACCTS intervention : 10 % ( 4 - 16 , P 7 % . CONCLUSIONS In an urban Caucasian trial population with blood glucose HbA(1c ) > 7 % , PACCTS facilitated significant improvement in glycemic control . Further research should extend the validity of findings to rural communities and other ethnic groups , as well as to smoking and lipid and blood pressure control",
"BACKGROUND Type 2 diabetes mellitus is increasing in incidence and research has shown that normalization of blood glucose levels can moderate the risk of microvascular and neurological complications . AIM The purpose of this study was to investigate the effect of nurse telephone calls on glycosylated haemoglobin ( HbA1c ) levels and adherence to diabetes control recommendations . METHODS A r and omized design with control and experimental groups being assessed pre- and post intervention was used to assess the effectiveness of nurse telephone calls . Twenty patients were r and omly assigned to an intervention group and 16 to a control group . The goal of the intervention was to keep blood glucose concentrations close to the normal range ( HbA1c continued education and reinforcement of diet , exercise , medication adjustment recommendations , as well as frequent self-monitoring of blood glucose levels . Telephone intervention was performed twice per week for the first month and then weekly for the second and third month . Participants were requested to write self-management logs including blood glucose levels , diet and an exercise diary . A dietitian analysed the diet diaries and participants were informed about their results by telephone or mail . All medication adjustments were communicated to participants ' doctors . The HbA1c and diabetes adherence were measured before and after the intervention . RESULTS Patients in the intervention group had a mean decrease of 1.2 % in HbA1c levels and those in the control group had a mean increase of 0.6 % in HbA1c levels . The intervention group had greater diet and blood glucose testing adherence than the control group . CONCLUSION These findings indicate that a nurse telephone intervention can improve HbA1c , and diet and blood glucose testing adherence",
"AIMS The aim of this study was to test the feasibility and impact of an intervention consisting of self-monitored blood pressure , medicine review , a Digital Versatile Disc , and motivational interviewing telephone calls to help people with diabetes and kidney disease improve their blood pressure control and adherence to prescribed medications . BACKGROUND People with co-existing diabetes , kidney disease and hypertension require multiple medications to manage their health . About 50 % of people are non-adherent to their prescribed medications with non-adherence increasing in the presence of chronic conditions . DESIGN R and omized controlled trial . METHODS Patients aged ≥18 years with diabetes , chronic kidney disease and systolic hypertension were recruited from nephrology and diabetes out patients ' clinics of an Australian metropolitan hospital between 2008 - 2009 . Participants were r and omly allocated on a 1:1 basis to one of two groups in a r and omized controlled trial : the intervention delivered over 3 months ( n = 39 ) and usual care ( n = 41 ) , with follow-up at 3 , 6 and 9 months postintervention . People collecting data and assessing outcomes were blinded to group assignment . RESULTS Seventy-five participants completed the study . The intervention was acceptable and feasible for this cohort . There were no statistically significant differences between groups , although the mean systolic blood pressure reduction in the intervention group ( n = 36 ) was -6·9 mmHg 95 % CI ( -13·8 , -0·02 ) at 9 months postintervention . CONCLUSION The study was feasible and statistically significant differences may be determinable in a larger sample to overcome the variability between groups , paying attention to recommendations for further research . TRIAL REGISTRATION The trial was prospect ively registered with the Australian and New Zeal and Clinical Trials Register ( ACTRN12607000044426 )",
"ABSTRACT OBJECTIVE To compare physiological outcomes and satisfaction for followup care between an interactive diabetes internet program and Diabetes Education Centres . METHOD A r and omized , controlled trial with outcomes of glycosylated hemoglobin ( A1C ) , fasting blood glucose , total cholesterol , triglycerides ( TG ) , high-density lipoprotein cholesterol , lowdensity lipoprotein cholesterol and patient satisfaction . Enrollment was staggered , with individuals assessed at baseline , 3 , 6 and 12 months . RESULTS Fifty-seven participants completed the study ( 20 control , 37 internet ) . Physiological outcomes were not statistically different between the 2 groups . However , within-group comparisons demonstrated a significant improvement in the internet group 's A1C , TG and satisfaction levels from baseline to 3 and 6 months ( p the internet program in other applications for diabetes management is needed",
"AIM This pilot study evaluated the short-term benefits of a telemonitoring-supplemented focused diabetic education compared with education alone in participants with Type 2 diabetes who were fasting during Ramadan . METHODS In this pilot mixed- method study , we identified 37 participants and r and omly allocated them to either a telemonitoring group ( n = 18 ) or a group receiving Ramadan-focused pre-education only ( usual care ; n = 19 ) . The telemonitoring group received goal - setting and personalized feedback . RESULTS The telemonitoring group was less likely to experience hypoglycaemia than the usual care group ( odds ratio : 0.1273 ; 95 % confidence interval : 0.0267 - 0.6059 ) . No significant differences were noted in glycaemic control at the end of study . Participants viewed telemedicine as a more convenient alternative although technological barriers remain a concern . CONCLUSIONS The results of this study reinforce the need for monitoring as well as educational initiatives for Muslims with diabetes who fast during Ramadan . Telemonitoring offers an attractive option requiring further research . ( Clinical Trial Registry No. NCT02189135 )",
"A r and omized controlled trial was conducted to evaluate the impact of an automated telephone intervention on glycemic control in patients with type 2 diabetes . One hundred twenty participants were r and omly assigned to a treatment group that received a daily , automated telephone message regarding diabetes or to a control group that received usual care . The treatment group demonstrated a significant improvement in the frequency of self-monitoring of blood glucose levels compared with the control group ( P positive attitudes toward diabetes and a reduction in perceived monitoring and exercise barriers were seen in the intervention group compared with the control group",
"STUDY OBJECTIVE Increasingly , low-income inner-city patients with diabetes utilize emergency departments ( EDs ) for acute and chronic care . We seek to determine whether a scalable , low-cost , unidirectional , text message-based mobile health intervention ( TExT-MED ) improves clinical outcomes , increases healthy behaviors , and decreases ED utilization in a safety net population . METHODS We conducted an r and omized controlled trial of 128 adult patients with poorly controlled diabetes ( glycosylated hemoglobin [ Hb A1C ] level ≥8 % ) in an urban , public ED . The TExT-MED group received 2 daily text messages for 6 months in English or Spanish . The primary outcome was change in Hb A1C level . Secondary outcomes included changes in medication adherence , self-efficacy , performance of self-care tasks , quality of life , diabetes-specific knowledge , ED utilization , and patient satisfaction . RESULTS Hb A1C level decreased by 1.05 % in the TExT-MED group compared with 0.60 % in the controls ( Δ0.45 ; 95 % confidence interval [ CI ] -0.27 to 1.17 ) at 6 months . Secondary outcomes favored the TExT-MED group , with the most sizable change observed in self-reported medication adherence ( as measured by the Morisky Medication Adherence Scale , an 8-point vali date d scale with higher scores representing better adherence ) , which improved from 4.5 to 5.4 in the TExT-MED group compared with a net decrease of -0.1 in the controls ( Δ1.1 [ 95 % CI 0.1 to 2.1 ] ) . Effects were larger among Spanish speakers for both medication adherence ( 1.1 versus -0.3 ; Δ1.4 ; 95 % CI 0.2 to 2.7 ) and Hb A1C ( -1.2 % versus -0.4 % ) in the TExT-MED group . The proportion of patients who used emergency services trended lower in the TExT-MED group ( 35.9 % versus 51.6 % ; Δ15.7 % ; 95 % CI 9.4 % to 22 % ) . Overall , 93.6 % of respondents enjoyed TExT-MED and 100 % would recommend it to family/friends . CONCLUSION The TExT-MED program did not result in a statistically significant improvement in Hb A1C . However , trends toward improvement in the primary outcome of Hb A1C and other secondary outcomes , including quality of life , were observed , the most pronounced being improved medication adherence . TExT-MED also decreased ED utilization . These findings were magnified in the Spanish-speaking subgroup . Technologies such as TExT-MED represent highly scalable , low-cost , and widely accessible solutions for safety-net ED population",
"BACKGROUND Control of serum glucose levels is essential for the reduction of complications of diabetes . Telemedicine is one strategy through which serum glucose control can be improved . METHODS A total of 35 adult , insulin-treated patients with diabetes ( type 1 and type 2 ) were enrolled in the present study ( 63.0 + /- 10 years of age , 63 % female ) and r and omized to telemedicine monitoring ( including cordless , remote glucose monitor , and transmitter , n = 17 ) , or conventional follow-up ( n = 18 ) . Metabolic parameters were evaluated , and a quality of life question naire was administered both pre- and post-treatment . RESULTS Groups were similar at baseline in terms of demographic , quality of life , and metabolic parameters . Significant differences in post-treatment metabolic parameters were not observed , although serum glucose was marginally elevated in the control group compared to the telemedicine group ( 214 + /- 65 mg/dL vs. 171 + /- 77 mg/dL , P = 0.09 ) . On the other h and , being clinical ly symptom-free ( 71 % vs. 11 % , P = 0.003 ) , having no hypoglycemic events ( 82 % vs. 17 % , P = 0.0001 ) , and having no hyperglycemic events ( 65 % vs. 17 % , P = 0.004 ) were all significantly more frequently reported in the telemedicine group compared to the control group . Compared to the control group , the telemedicine group reported experiencing significantly less anxiety , treatment difficulty , depression , disease-associated life complications , and feelings of impotence or ineptitude and significantly greater improvement in personal control over glucose , weight , and overall diabetes . CONCLUSIONS Though post-treatment metabolic differences were not observed between treatment groups , the telemedicine group reported significantly greater post-treatment experiences of improved quality of life and sense of control over the disease . Thus patient satisfaction can be enhanced through the use of telemedicine",
"BACKGROUND The aim of this study is to evaluate the effect of a web-based comprehensive information system , consisting of Internet and cellular phone use , on blood glucose control . METHODS We established eMOD ( electronic Management of Diabetes ) , a web-based ubiquitous information system , for cell phone users along with a website for Internet users to provide diabetes education . We examined whether this information system has the same impact on glycemic control as conventional education for the diabetes patient . Forty volunteers were enrolled and r and omly assigned to either the eMOD experimental group ( n = 20 ) or the control group ( n = 20 ) . Blood glucose and glycated hemoglobin ( A1C ) levels were evaluated at baseline and after 6 months . RESULTS The two groups were homogeneous in terms of age , sex , and diabetes ' duration at baseline . A1C ( from 9.0 + /- 2.3 % to 7.5 + /- 1.4 % , P = 0.031 ) and postpr and ial glucose level ( 228.1 + /- 79.7 to 173.5 + /- 50.2 mg/dL , P = 0.030 ) were significantly decreased over time in the intervention group but not in the control group . There was a significant relationship between the change in A1C and the frequency of access to the eMOD system via cellular phone ( r = 0.766 , P = 0.03 ; coefficient -0.147 ) . CONCLUSIONS A1C was improved by a web-based intervention not only via computer but also via cellular phone at 6 months post-initiation in patients with type 2 diabetes . These results indicate that the use of a convenient web-based education system could be more effective for glycemic control than traditional education for diabetes patients",
"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",
"Background Physical activity ( PA ) is associated with reduced morbidity and mortality in individuals with type 2 diabetes mellitus ( T2DM ) ; however , most T2DM adults are insufficiently active . Purpose To explore the effectiveness of two innovative/theoretically based behavioral-change strategies to increase PA and reduce hemoglobin A1c ( A1c ) in T2DM adults . Methods Participants ( n = 287 ) were r and omly assigned to a control group or an intervention group ( i.e. , print-based material s/pedometer group or print-based material s/pedometer plus telephone-counseling group ) . Changes in PA and A1c and other clinical measures were examined by Linear Mixed Model analyses over 18 months , along with moderating effects for gender and age . Results PA and A1c levels did not significantly change in intervention groups . Step counts significantly increased in the print-based material s and pedometer plus telephone counseling group , for women . Conclusions No significant effects were found for PA or A1c levels for T2DM adults . The multi-component strategy including telephone counseling may have potential for women . The trial was registered on Clinical Trials.gov identifier : NCT00221234"
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411742fe-06ff-11f0-808a-c43d1ab1c353
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Background The Canadian Society for Exercise Physiology convened representatives of national organizations , research experts , method ologists , stakeholders , and end-users who followed rigorous and transparent guideline development procedures to create the Canadian 24-Hour Movement Guidelines for the Early Years ( 0–4 years ) : An Integration of Physical Activity , Sedentary Behaviour , and Sleep . These novel guidelines for children of the early years embrace the natural and intuitive integration of movement behaviours across the whole day ( 24-h period ) . Methods The development process was guided by the Appraisal of Guidelines for Research and Evaluation ( AGREE ) II instrument . Four systematic review s ( physical activity , sedentary behaviour , sleep , combined behaviours ) examining the relationships within and among movement behaviours and several health indicators were completed and interpreted by a Guideline Development Panel . The systematic review s that were conducted to inform the development of the guidelines , and the framework that was applied to develop the recommendations , followed the Grading of Recommendations Assessment , Development , and Evaluation ( GRADE ) methodology . Complementary compositional analyses were performed using data from the Canadian Health Measures Survey to examine the relationships between movement behaviours and indicators of adiposity . A review of the evidence on the cost effectiveness and re source use associated with the implementation of the proposed guidelines was also undertaken . A stakeholder survey ( n = 546 ) , 10 key informant interviews , and 14 focus groups ( n = 92 participants ) were completed to gather feedback on draft guidelines and their dissemination . Results The guidelines provide evidence -informed recommendations as to the combinations of light- , moderate- and vigorous-intensity physical activity , sedentary behaviours , and sleep that infants ( should achieve for a healthy day ( 24 h ) . Proactive dissemination , promotion , implementation , and evaluation plans were prepared to optimize uptake and activation of the new guidelines . Conclusions These guidelines represent a sensible evolution of public health guidelines whereby optimal health is framed within the balance of movement behaviours across the whole day , while respecting preferences of end-users . Future research should consider the integrated relationships among movement behaviours , and similar integrated guidelines for other age groups should be developed
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"OBJECTIVE To determine the television- , DVD- , and video-viewing habits of children younger than 2 years . DESIGN A telephone survey of 1009 parents of children aged 2 to 24 months . SETTING Parents in Minnesota and Washington state were surveyed . PARTICIPANTS A r and om sample of parents of children born in the previous 2 years was drawn from birth certificate records . Households in which English was not spoken were excluded , as were children with major disabilities . MAIN OUTCOME MEASURE The amount of regular television and DVD/video viewing by content , reasons for viewing , and frequency of parent-child coviewing . RESULTS By 3 months of age , about 40 % of children regularly watched television , DVDs , or videos . By 24 months , this proportion rose to 90 % . The median age at which regular media exposure was introduced was 9 months . Among those who watched , the average viewing time per day rose from 1 hour per day for children younger than 12 months to more than 1.5 hours per day by 24 months . Parents watched with their children more than half of the time . Parents gave education , entertainment , and babysitting as major reasons for media exposure in their children younger than 2 years . CONCLUSIONS Parents should be urged to make educated choices about their children 's media exposure . Parental hopes for the educational potential of television can be supported by encouraging those parents who are already allowing screen time to watch with their children",
"Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results",
"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 : We established a program of research to improve the development , reporting and evaluation of practice guidelines . We assessed the construct validity of the items and user ’s manual in the β version of the AGREE II . Methods : We design ed guideline excerpts reflecting high- and low- quality guideline content for 21 of the 23 items in the tool . We design ed two study packages so that one low- quality and one high- quality version of each item were r and omly assigned to each package . We r and omly assigned 30 participants to one of the two packages . Participants review ed and rated the guideline content according to the instructions of the user ’s manual and completed a survey assessing the manual . Results : In all cases , content design ed to be of high quality was rated higher than low- quality content ; in 18 of 21 cases , the differences were significant ( p appropriate , easy to use , and helpful in differentiating guidelines of varying quality , with all scores above the mid-point of the seven-point scale . Considerable feedback was offered on how the items and manual of the β-AGREE II could be improved . Interpretation : The validity of the items was established and the user ’s manual was rated as highly useful by users . We used these results and those of our study presented in part 1 to modify the items and user ’s manual . We recommend AGREE II ( available at www.agreetrust.org ) as the revised st and ard for guideline development , reporting and evaluation"
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4117433a-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Physical activity has been shown to be beneficial for the prevention and management of hypertension . In the general population , physical activity has been shown to decrease mortality . PURPOSE The purpose of this systematic review was to identify and synthesize the literature examining the impact of physical activity on mortality in patients with high blood pressure ( BP ) . METHODS An extensive search was conducted by two independent authors using Medline , Embase and Cochrane Library electronic data bases ( between 1985 and January 2012 ) and manual search from the reference list of relevant articles . Inclusion criteria were as follows : longitudinal design with minimum 1-year follow-up ; hypertensive status of the cohort was indicated ; and BP , physical activity , and mortality were measured . RESULTS Six articles evaluating a combined total of 48 , 448 men and 47 , 625 women satisfied the inclusion criteria . Cardiovascular and /or all-cause mortality were shown to be inversely related to physical activity in all studies . For example , patients with high BP who participated in any level of physical activity had a reduced risk ( by 16 - 67 % ) of cardiovascular mortality , whereas a greater than two-fold increase in risk of mortality was noted in nonactive individuals . However , activity classification and parameters , such as frequency , duration , intensity , and volume , as well as BP status , were not consistent across studies . CONCLUSIONS Regular physical activity is beneficial for reducing mortality in patients with high BP . More research is needed to establish the impact of specific kinds of physical activity and whether any differences exist between sexes
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"It has been postulated that platelet function plays an important role in the initiation of atherosclerosis . Currently there are no definitive data on the longer-term effects of regular physical exercise on platelet function in humans . We assessed the influence of regular moderate-intensity physical exercise ( brisk walking to slow jogging ) on platelet aggregation in a population -based sample of middle-aged , overweight , mildly hypertensive men in eastern Finl and . In this controlled study , we evaluated the net effect of exercise on platelet aggregation by study ing changes in optical density and ATP release in platelet-rich plasma . A significant inhibition of secondary platelet aggregation from 27 % to 36 % was observed in the men taking regular exercise . These findings give new insight into the possible protective effects of exercise against the risk of ischemic heart disease",
"Background —In stable coronary artery disease ( CAD ) , exercise training has well-documented positive effects on arterial endothelial function . NO derived from endothelial NO synthase ( eNOS ) is regarded as a protective factor against atherosclerosis . The aim of the present study was to investigate the effects of exercise training on the endothelial function in relation to the expression of eNOS and Akt-dependent eNOS phosphorylation in the left internal mammary artery ( LIMA ) of patients with stable CAD . Methods and Results —In 17 training patients ( T ) and 18 control patients ( C ) , endothelium-dependent vasodilation and average peak flow velocity ( APV ) in response to acetylcholine were measured invasively at study beginning and after 4 weeks in the LIMA . In LIMA tissue sample d during bypass surgery , eNOS expression and content of pospho-eNOS-Ser1177 , Akt , and phospho-Akt were determined by Western blot and quantitative reverse transcriptase – polymerase chain reaction . After exercise training , LIMA APV in response to acetylcholine was increased by 56±8 % ( from + 48±8 % at beginning to + 104±11 % after 4 weeks , P higher eNOS protein expression ( T 1.0±0.7 versus C 0.5±0.3 arbitrary units , P higher eNOS Ser1177-phosphorylation levels in LIMA-endothelium ( 1.2±0.9 versus 0.3±0.2 arbitrary units , P between Akt phosphorylation and phospho-eNOS levels ( R = 0.80 , P between phospho-eNOS and & Dgr ; APV ( R = 0.59 , P Conclusions —Exercise training in stable CAD leads to an improved agonist-mediated endothelium-dependent vasodilatory capacity . The change in acetylcholine-induced vasodilatation was closely related to a shear stress – induced/Akt-dependent phosphorylation of eNOS on Ser1177",
"OBJECTIVE To test whether weight loss may improve endothelial dysfunction in human obesity , we recruited 28 healthy obese subjects , aged 30 - 46 years , with BMI 30 - 43 kg/m(2 ) . RESEARCH DESIGN AND METHODS Endothelium-dependent and -independent vasodilation were investigated by intra-arterial infusion of increasing doses of acetylcholine ( ACh ; 7.5 , 15 , and 30 microg x ml(-1 ) x min(-1 ) ) and sodium nitroprusside ( 0.8 , 1.6 , and 3.2 microg x ml(-1 ) x min(-1 ) ) . Insulin resistance was estimated by homeostasis model assessment ( HOMA ) . Weight loss was obtained by caloric restriction and physical activity . RESULTS We observed a significant reduction in BMI ( from 33.1 + /- 4.2 to 27.5 + /- 4.5 kg/m(2 ) , -16.9 % , P waist circumference ( from 108.2 + /- 12.1 to 96.8 + /- 12.9 cm , -10.5 % , P Weight loss was also associated with a significant increase in ACh-stimulated forearm blood flow ( FBF ) , from 7.4 + /- 2.8 to 12.9 + /- 3.4 ml . 100 ml(-1 ) of tissue x min(-1 ) kg/m(2 ) ( P FBF was HOMA , accounting for 44.5 % of the variation , whereas the addition of BMI explained another 2.3 % of the variation . CONCLUSIONS Our data demonstrate that energy-restricted diet associated with physical activity induce a significant and clinical ly relevant improvement in ACh-stimulated vasodilation in obese healthy subjects",
"Abstract — Prospect i ve studies on physical activity in relation to the risk for hypertension are scant , particularly in women . This study aim ed at finding out whether regular physical activity can reduce the risk of hypertension in both men and women , and in subjects with and without overweight . We prospect ively followed 8302 Finnish men and 9139 women aged 25 to 64 years without a history of antihypertensive drug use , coronary heart disease , stroke , and heart failure at baseline . Both single and joint associations of physical activity and body mass index with the risk of hypertension were examined using Cox proportional hazard models . During a mean followup of 11 years , there were 1600 incident cases of drug-treated hypertension . Multivariate-adjusted hazards ratios of hypertension associated with light , moderate , and high physical activity were 1.00 , 0.63 , and 0.59 in men ( Ptrend Multivariate-adjusted hazards ratios of hypertension based at different levels of body mass index ( for baseline systolic blood pressure did not affect the protective effect associated with physical activity , but it weakened markedly the association between body mass index and hypertension . The present study indicates that regular physical activity and weight control can reduce the risk of hypertension . The protective effect of physical activity was observed in both sexes regardless of the level of obesity",
"BACKGROUND Physical activity is associated with low mortality in men , but little is known about the association in women , different age groups , and everyday activity . OBJECTIVE To evaluate the relationship between levels of physical activity during work , leisure time , cycling to work , and sports participation and all-cause mortality . DESIGN Prospect i ve study to assess different types of physical activity associated with risk of mortality during follow-up after the subsequent examination . Mean follow-up from examination was 14.5 years . SETTING Copenhagen University Hospital , Copenhagen , Denmark . PARTICIPANTS Participants were 13,375 women and 17,265 men , 20 to 93 years of age , who were r and omly selected . Physical activity was assessed by self-report , and health status , including blood pressure , total cholesterol level , triglyceride levels , body mass index , smoking , and educational level , was evaluated . MAIN OUTCOME MEASURE All-cause mortality . RESULTS A total of 2,881 women and 5,668 men died . Compared with the sedentary , age- and sex-adjusted mortality rates in leisure time physical activity groups 2 to 4 were 0.68 ( 95 % confidence interval , 0.64 - 0.71 ) , 0.61 ( 95 % confidence interval , 0.57 - 0.66 ) , and 0.53 ( 95 % confidence interval , 0.41 - 0.68 ) , respectively , with no difference between sexes and age groups . Within the moderately and highly active persons , sports participants experienced only half the mortality of non participants . Bicycling to work decreased risk of mortality in approximately 40 % after multivariate adjustment , including leisure time physical activity . CONCLUSIONS Leisure time physical activity was inversely associated with all-cause mortality in both men and women in all age groups . Benefit was found from moderate leisure time physical activity , with further benefit from sports activity and bicycling as transportation",
"OBJECTIVES Physical activity ( PA ) is a preventive strategy for cardiovascular disease and for managing cardiovascular risk factors . There is little information on the effectiveness of PA for the prevention of cardiovascular outcomes once cardiovascular disease is present . Thus , we studied the relationship between PA at baseline and cardiovascular events in a high-risk population . DESIGN A prespecified analyses of observational data in a prospect i ve , r and omized hypertension study . SETTING Losartan Intervention For Endpoint reduction in hypertension ( LIFE ) study . SUBJECTS Hypertension and left ventricular hypertrophy ( LVH ) ( n = 9,193 ) . INTERVENTIONS Losartan versus atenolol . MAIN OUTCOME MEASURES Reported level of PA : never exercise , exercise 30 min twice per week at baseline and after a mean of 4.8 years of treatment with losartan- versus atenolol-based therapy . Risk reductions were calculated by level of PA for the primary composite end-point and its components cardiovascular death , stroke and myocardial infa rct ion , and also all-cause mortality and new-onset diabetes . RESULTS A modest level of PA ( > 30 min twice per week ) was associated with significant reductions in risk for the primary composite end-point [ adjusted hazard ratio ( aHR ) 0.70 , P all-cause mortality ( aHR 0.65 , P new-onset diabetes ( aHR 0.66 , P 30 min twice per week ) in patients with hypertension and LVH in the LIFE study was associated with significant reductions in risk for the primary composite end-point and its components of cardiovascular death , stroke , and myocardial infa rct ion , all-cause mortality , and new-onset diabetes",
"OBJECTIVE To ascertain the relationship of physical inactivity and short-term all-cause mortality in a prospect i ve cohort of r and omly selected managed care organization members aged 40 years and older who have multiple chronic diseases . METHODS Clinical data bases were used to identify all health plan members aged 40 years and older with 2 or more chronic health conditions ( hypertension , coronary heart disease , diabetes mellitus , or dyslipemia ) in 1994 . A r and om sample of 2336 members was surveyed by mail and telephone interview regarding their health-related behaviors . Survey data were linked to mortality data from the 1995 to 1997 Minnesota Death Index . Cox proportional hazards regression was used to ascertain the association between physical inactivity and subsequent all-cause mortality , adjusting for potential confounders . RESULTS Members who reported less than 30 minutes a week of physical activity at baseline had a subsequent mortality risk ratio of 2.82 ( P mortality risk persisted ( mortality risk ratio , 2.15 ; P adults with chronic diseases , the physically inactive had higher observed mortality within a 42-month period . If physical inactivity reflects an independent mortality risk , efforts to maintain physical activity in such patients may yield significant clinical benefits within a short period . By contrast , if inactivity is primarily a proxy for other factors that elevate mortality risks , a simple physician inquiry regarding inactivity may help to identify patients at risk of death",
"The benefits of aerobic exercise ( AE ) training on blood pressure ( BP ) and arterial stiffness are well established , but the effects of resistance training are less well delineated . The purpose of this study was to determine the impact of resistance vs aerobic training on haemodynamics and arterial stiffness . Thirty pre- or stage-1 essential hypertensives ( 20 men and 10 women ) , not on any medications , were recruited ( age : 48.2±1.3 years ) and r and omly assigned to 4 weeks of either resistance ( RE ) or AE training . Before and after training , BP , arterial stiffness ( pulse wave velocity ( PWV ) ) and vasodilatory capacity ( VC ) were measured . Resting systolic BP ( SBP ) decreased following both training modes ( SBP : RE , pre 136±2.9 vs post 132±3.4 ; AE , pre 141±3.8 vs post 136±3.4 mm Hg , P=0.005 ; diastolic BP : RE , pre 78±1.3 vs post 74±1.6 ; AE , pre 80±1.6 vs post 77±1.7 mm Hg , P=0.001 ) . Central PWV increased ( P=0.0001 ) following RE ( 11±0.9–12.7±0.9 m s−1 ) but decreased after AE ( 12.1±0.8–11.1±0.8 m s−1 ) . Peripheral PWV also increased ( P=0.013 ) following RE ( RE , pre 11.5±0.8 vs post 12.5±0.7 m s−1 ) and decreased after AE ( AE , pre 12.6±0.8 vs post 11.6±0.7 m s−1 ) . The VC area under the curve ( VCAUC ) increased more with RE than that with AE ( RE , pre 76±8.0 vs post 131.1±11.6 ; AE , pre 82.7±8.0 vs post 110.1±11.6 ml per min per s per 100 ml , P=0.001 ) . Further , peak VC ( VCpeak ) increased more following resistance training compared to aerobic training ( RE , pre 17±1.9 vs post 25.8±2.1 ; AE , pre 19.2±8.4 vs post 22.9±8.4 ml per min per s per 100 ml , P=0.005 ) . Although both RE and AE training decreased BP , the change in pressure may be due to different mechanisms",
"BACKGROUND Blood pressure reduction achieved with beta-blockers and diuretics is the best recorded intervention to date for prevention of cardiovascular morbidity and death in patients with hypertension . Left ventricular hypertrophy ( LVH ) is a strong independent indicator of risk of cardiovascular morbidity and death . We aim ed to establish whether selective blocking of angiotensin II improves LVH beyond reducing blood pressure and , consequently , reduces cardiovascular morbidity and death . METHODS We did a double-masked , r and omised , parallel-group trial in 9193 participants aged 55 - 80 years with essential hypertension ( sitting blood pressure 160 - 200/95 - 115 mm Hg ) and LVH ascertained by electrocardiography ( ECG ) . We assigned participants once daily losartan-based or atenolol-based antihypertensive treatment for at least 4 years and until 1040 patients had a primary cardiovascular event ( death , myocardial infa rct ion , or stroke ) . We used Cox regression analysis to compare regimens . FINDINGS Blood pressure fell by 30.2/16.6 ( SD 18.5/10.1 ) and 29.1/16.8 mm Hg ( 19.2/10.1 ) in the losartan and atenolol groups , respectively . The primary composite endpoint occurred in 508 losartan ( 23.8 per 1000 patient-years ) and 588 atenolol patients ( 27.9 per 1000 patient-years ; relative risk 0.87 , 95 % CI 0.77 - 0.98 , p=0.021 ) . 204 losartan and 234 atenolol patients died from cardiovascular disease ( 0.89 , 0.73 - 1.07 , p=0.206 ) ; 232 and 309 , respectively , had fatal or non-fatal stroke ( 0.75 , 0.63 - 0.89 , p=0.001 ) ; and myocardial infa rct ion ( non-fatal and fatal ) occurred in 198 and 188 , respectively ( 1.07 , 0.88 - 1.31 , p=0.491 ) . New-onset diabetes was less frequent with losartan . Interpretation Losartan prevents more cardiovascular morbidity and death than atenolol for a similar reduction in blood pressure and is better tolerated . Losartan seems to confer benefits beyond reduction in blood pressure",
"OBJECTIVE To determine whether self-reported physical activity predicts a decreased rate of coronary heart disease ( CHD ) and all-cause mortalities in middle-aged men when rates are adjusted for known confounders . DESIGN Cohort Analytic Study of Israeli government employees in 1963 . SUBJECTS Eight thous and four hundred sixty-three Israeli male government employees , aged 40 years or older , representing six areas of birth , excluding those with known cardiovascular disease in either 1963 or 1965 , from an original cohort of 10,059 . MAIN OUTCOME MEASURE Comparison of rates of death due to CHD and all causes , determined from death certificates in 21 years of follow-up , for subjects with different baseline levels of self-reported leisure-time and work-related physical activities measured in 1965 . RESULTS Self-reported leisure-time but not work-related physical activity was inversely related to both CHD ( adjusted relative risk , 0.79 ; 95 % confidence interval , 0.66 to 0.95 ) and all-cause mortalities ( adjusted relative risk , 0.91 ; 95 % confidence interval , 0.83 to 0.99 ) . Most of the apparent benefit accrued was from light physical activity on less than a daily basis . These inverse relationships persisted after adjustment for age , systolic blood pressure , cigarette smoking , total and high-density lipoprotein cholesterol levels , body mass index , psychosocial factors , and other potential confounders . CONCLUSION Baseline levels of self-reported leisure-time physical activity predicted a decreased rate of CHD and all-cause mortalities in employed middle-aged Israeli men followed up prospect ively for 21 years",
"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",
"The treatment of hypertension mainly with diuretics and beta blockers reduces cardiovascular mortality and morbidity , largely due to a decreased incidence of stroke , whereas the beneficial effects of antihypertensive therapy on the occurrence of coronary events have been less than expected from epidemiological studies . Furthermore , treated hypertensive patients still have a higher cardiovascular complication rate , compared with matched normotensives . This is particularly evident in patients with left ventricular hypertrophy ( LVH ) , a major independent risk indicator for cardiovascular disease . In addition to elevating blood pressure , angiotensin II ( A-II ) exerts an important influence on cardiac structure and function , stimulating cell proliferation and growth . Thus , to further reduce morbidity and mortality when treating hypertensive patients , it may be important to effectively block the effects of A-II . This can be achieved directly at the A-II receptor level by losartan , the first of a new class of antihypertensive agents . It therefore seems pertinent to investigate whether selective A-II receptor blockade with losartan not only lowers blood pressure but also reduces LVH more effectively than current therapy , and thus improves prognosis . The Losartan Intervention For Endpoint reduction ( LIFE ) in Hypertension study is a double-blind , prospect i ve , parallel group study design ed to compare the effects of losartan with those of the beta-blocker atenolol on the reduction of cardiovascular morbidity and mortality in approximately 8,300 hypertensive patients ( initial sitting diastolic blood pressure 95 to 115 mm Hg or systolic blood pressure 160 to 200 mm Hg ) with electrocardiographically documented LVH . The study , which will continue for at least 4 years and until 1,040 patients experience one primary endpoint , has been design ed with a statistical power that will detect a difference of at least 15 % between groups in the incidence of combined cardiovascular morbidity and mortality . It is also the first prospect i ve study with adequate power to link reversal of LVH to reduction in major cardiovascular events . The rationale of the study , which will involve more than 800 clinical centers in Sc and inavia , the United Kingdom , and the United States , is discussed , and the major features of its design and general organization are described . On April 30 , 1997 , when inclusion was stopped , 9,218 patients had been r and omized",
"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",
"Aim /hypothesisLeisure-time physical activity can reduce the risk of Type 2 diabetes , but the potential effect of different types of physical activity is still uncertain . This study is to examine the relationship of occupational , commuting and leisure-time physical activity with the incidence of Type 2 diabetes . Methods We prospect ively followed 6898 Finnish men and 7392 women of 35 to 64 years of age without a history of stroke , coronary heart disease , or diabetes at baseline . Hazards ratios of incidence of Type 2 diabetes were estimated by levels of occupational , commuting , and leisure-time physical activity . Results During a mean follow-up of 12 years , there were 373 incident cases of Type 2 diabetes . In both men and women combined , the hazards ratios of diabetes associated with light , moderate and active work were 1.00 , 0.70 and 0.74 ( p=0.020 for trend ) after adjustment for confounding factors ( age , study year , sex , systolic blood pressure , smoking , education , the two other types of physical activity and BMI ) . The multivariate-adjusted hazards ratios of diabetes with none , 1 to 29 , and more than 30 min of walking or cycling to and from work were 1.00 , 0.96 , and 0.64 ( p=0.048 for trend ) . The multivariate-adjusted hazards ratios of diabetes for low , moderate , high levels of leisure-time physical activity were 1.00 , 0.67 , and 0.61 ( p=0.001 for trend ) ; after additional adjustment for BMI , the hazards ratio was no longer significant . Conclusions /interpretationModerate and high occupational , commuting or leisure-time physical activity independently and significantly reduces risk of Type 2 diabetes among the middle-aged general population",
"AIMS Given that studies of individuals with Type 2 diabetes or impaired glucose tolerance indicate that physical activity has a normalizing effect on several indices of coronary heart disease ( CHD ) risk-including body weight , blood pressure , blood lipids , and cardiorespiratory fitness-it is plausible that activity may reduce CHD incidence in this group in the long term . The aim of the present analysis was to explore this hypothesis using data from a prospect i ve observational study . METHODS We examined the relation of two indices of physical activity-walking pace and leisure activity-to total mortality , CHD , and other cardiovascular diseases in a 25-year follow-up of 6408 male British Civil Servants who underwent an oral glucose tolerance test at study entry . RESULTS In 352 men who were identified as having Type 2 diabetes or impaired glucose tolerance ( diabetes/IGT ) at baseline , 215 had died at follow-up and , in 6056 normoglycaemics , 2550 deaths had occurred . The two indices of physical activity were inversely related to all-cause , CHD , and other cardiovascular disease mortality in both normoglycaemics and in men with diabetes/IGT . Although these associations were attenuated somewhat after statistical adjustment for a range of covariates , the majority held , suggesting an independent effect for physical activity . The gradient of the activity-mortality association was steeper in individuals with diabetes/IGT in comparison with the normoglycaemics , with the linear trend across activity levels for CHD risk differing markedly in the analyses of both walking pace ( P-value for interaction test = 0.05 ) and leisure activity ( P-value = 0.02 ) . CONCLUSIONS The findings of the present analysis of men with Type 2 diabetes/IGT provide support for those from a small number of other studies of persons with Type 2 diabetes suggesting that this group may benefit from physical activity in terms of CHD risk reduction",
"The relation of leisure time and occupational physical activity to the risk of death from ischemic heart disease was investigated in a cohort of 15,088 persons aged 30 - 59 years who had no history of cardiovascular disease or other condition which hindered physical activity . Two population sample s were r and omly chosen from eastern Finl and . During a six-year follow-up , persons who were sedentary in leisure time ( relative risk = 1.3 , 95 % confidence interval ( CI ) = 1.1 - 1.6 ) or at work ( relative risk = 1.3 , 95 % CI = 1.1 - 1.6 ) had an excess risk of ischemic heart disease death when adjusted for age , health status , family history , and body mass index in multivariate logistic models . Adjustment for years of education , social network participation , cigarette consumption , serum cholesterol level , and blood pressure level weakened the residual association of low leisure time physical activity with the risk of ischemic heart disease death ( relative risk = 1.2 , 95 % CI = 1.0 - 1.5 ) , whereas the association for low occupational physical activity remained unchanged . The lack of leisure time physical activity and a sedentary occupation are associated with an increased risk of ischemic heart disease death , and the excess risk due to lack of leisure time physical activity is , in part , accounted for by other ischemic heart disease risk factors",
"PURPOSE The purpose of this study was to examine the long-term relationships between total physical activity and mortality from all causes and coronary heart disease ( CHD ) in the general population . METHODS A prospect i ve design was used , following participants for 29 years , beginning in 1960 . The study population consisted of a r and omly selected sample of white male ( n = 698 ) and female ( n = 763 ) residents of Buffalo , New York with a 79.0 % participation rate and follow-up rates of 96.0 % and 90.2 % in males and females , respectively . At baseline , comprehensive information was obtained regarding participants ' usual physical activity at work and during leisure time . RESULTS As of December 31 , 1989 , three hundred and two ( 43.3 % ) men and 276 ( 41.0 % ) women died , 109 ( 15.6 % ) and 81 ( 10.6 % ) from CHD , respectively . In men , a significant interaction was found between activity and body mass index ( BMI ) for both outcomes . In women , a significant activity by age interaction was observed . In non-obese men ( BMI 27.02 ) , activity was inversely associated with all-cause [ relative risk ( RR ) = 0.59 ; 95 % confidence interval ( CI ) , 0.39 - 0.89 ] and CHD mortality ( RR = 0.39 ; 95 % CI , 0.18 - 0.83 ) , independent from the effects of age and education . No such associations were found in obese men and increased risks could not be ruled out . Among women , younger participants ( age had a significantly reduced risk of CHD death with increased activity ( RR = 0.26 ; 95 % CI , 0.07 - 0.99 ) . No other significant associations were observed . CONCLUSIONS Physical activity favorably influences mortality risks in non-obese men and younger women . Gender-specific factors should be considered for potential effect modification",
"OBJECTIVE No previous long-term prospect i ve studies have examined if workers with low cardiorespiratory fitness have an increased risk of cardiovascular mortality due to high physical work dem and s. We tested this hypothesis . METHOD We carried out a 30-year follow-up of the Copenhagen Male Study of 5249 employed men aged 40 - 59 years . We excluded from follow-up 274 men with a history of myocardial infa rct ion , prevalent symptoms of angina pectoris , or intermittent claudication . We estimated physical fitness [ maximal oxygen consumption ( VO (2)Max ) ] using the Astr and cycling test and determined physical work dem and s with two self-reported questions . RESULTS In the Copenhagen Male Study , 587 men ( 11.9 % ) died due to ischaemic heart disease ( IHD ) . Using men with low physical work dem and s as the reference group , Cox analyses -- adjusted for age , blood pressure , smoking , alcohol consumption , body mass index , diabetes , and hypertension -- showed that high physical work dem and s were associated with an increased risk of IHD mortality in the least fit [ VO (2)Max range 15 - 26 , N=892 , hazard ratio ( HR ) 2.04 , 95 % confidence interval ( 95 % CI ) 1.20 - 3.49 ] and moderately fit ( VO (2)Max range 27 - 38 , N=3037 , HR 1.75 , 95 % CI 1.24 - 2.46 ) , but not among the most fit men ( VO (2)Max range 39 - 78 , N=1014 , HR 1.08 , 95 % CI 0.52 - 2.17 ) . We found a similar , although slightly weaker , relationship with respect to all-cause mortality . CONCLUSIONS The hypothesis was supported . Men with low and medium physical fitness have an increased risk of cardiovascular and all-cause mortality if exposed to high physical work dem and s. Ours observations suggest that , among men with high physical work dem and s , being physically fit protects against adverse cardiovascular effects",
"OBJECTIVE A 2-year follow-up study of a cohort of 200 historically disadvantaged older South Africans was conducted to : ( i ) characterise current levels of habitual physical activity ; ( ii ) relate physical activity to current risk factors for chronic disease ; and ( iii ) identify risk factors associated with 2-year mortality . The baseline sample , drawn in 1993 , was found to have a high prevalence of hypertension ( 71.7 % ) . RESEARCH DESIGN Retrospective cohort study . METHODS A baseline sample of 200 persons aged > or = 65 years , resident in the Cape Peninsula , was r and omly drawn by means of a two-stage cluster design . Baseline measurements included : anthropometry , waist/hip ratio , systolic and diastolic blood pressure , body mass index ( BMI ) , serum albumin , serum ferritin , haemoglobin and fasting plasma glucose levels , plasma lipid profiles , oral glucose tolerance test and self-reported health status . Subjects were revisited after 2 years , at which time an adapted version of the Yale Physical Activity Survey was administered and measurements of blood pressure and anthropometry were repeated . STATISTICAL ANALYSES Spearman 's rank-order correlations were used to describe relationships between various current risk factors and physical activity . Logistic regression was used to determine predictors of 2-year mortality from baseline data . RESULTS At follow-up , 142 of the subjects ( 66 men , 76 women ) were traced and measurements collected . Thirty-two subjects were reported to have died by relatives living in the same household ( 22 men , 10 women ) . Levels of reported physical activity in the survivors were two-thirds lower than those reported in a sample of North Americans of similar age . There was an inverse association between age and physical activity ( r = -0.31 ; P BMI and physical activity ( r = 0.29 ; P physical activity and systolic or diastolic blood pressure . In men , BMI in the lower tertile ( P = 0.07 ) and serum ferritin levels were positively associated with increased mortality . Serum albumin levels were protective over the 2-year follow-up period ( OR = 0.85 ; P Physical activity levels in this sample of older historically disadvantaged South Africans were habitually low . Simple anthropometric assessment s incorporating weight and waist/hip ratio , together with serum albumin measurements , may be useful to screen general health risk for older adults at primary care level and provide indications for social or medical intervention . Further , strategies for earlier detection and effective management of diabetes , particularly in older women , may reduce premature mortality in this population",
"-Losartan was the first available orally administered selective antagonist of the angiotensin II type 1 receptor developed for the treatment of hypertension . The Losartan Intervention For Endpoint ( LIFE ) Reduction in Hypertension Study is a double-blind , prospect i ve , parallel group study design ed to compare the effects of losartan with those of the beta-blocker atenolol on the reduction of cardiovascular morbidity and mortality . Patients with essential hypertension , aged between 55 and 80 years , and ECG-documented left ventricular hypertrophy ( LVH ) were included . Altogether , 9223 patients in Sc and inavia , the United Kingdom , and the United States were r and omized from June 1995 through April 1997 , and 9194 remain after exclusion of a study center at which irregularities were discovered . This population of hypertensives ( mean systolic/diastolic blood pressure , 174.4/97.8 mm Hg ) with LVH comprises women ( 54.1 % ) and men , mostly retired from active work ( mean age , 66.9 years ) , with a high prevalence of overweight ( mean body mass index , 28.0 kg/m2 ) , diabetes mellitus ( 12.3 % ) , lipid disorders ( 18.0 % ) , and symptoms or signs of coronary heart disease ( 15.1 % ) . There were fewer current smokers ( than in the general population , and approximately 7 % were nonwhite . Almost 30 % of participants had been untreated for at least 6 months when screened for the study . Only 1557 persons who entered the placebo run-in period of 14 days were excluded , predominantly because of sitting blood pressures above or below the predetermined range of 160 - 200/95 - 115 mm Hg and ECG-LVH criteria not met . By application of simple 12-lead ECG criteria for LVH ( Cornell voltage QRS duration product formula plus Sokolow-Lyon voltage read by a core laboratory ) , hypertensive patients with LVH with an average 5-year coronary heart disease risk of 22.3 % according to the Framingham score were identified . This population is now being treated ( goal , < 140/90 mm Hg ) in adherence with the protocol for at least 4 years after final enrollment ( ie , through April 2001 ) and until at least 1040 patients suffer myocardial infa rct ion , stroke , or cardiovascular death",
"Background Exercise lowers blood pressure and improves cardiovascular function , but little is known about whether exercise impacts cardiovascular morbidity and mortality independent of left ventricular hypertrophy ( LVH ) and LV geometry . Design Observational analysis of prospect ively obtained echocardiographic data within the context of a r and omized trial of antihypertensive treatment . Methods A total of 937 hypertensive patients with ECG LVH were studied by echocardiography in the Losartan Intervention For Endpoint reduction in hypertension study . Baseline exercise status was categorized as sedentary ( never exercise ) , intermediate ( ≤ 30 min twice/week ) , or physically active ( > 30 min twice/week ) . During 4.8-year follow-up , 105 patients suffered the primary composite endpoint of myocardial infa rct ion ( MI ) , stroke , or cardiovascular death . Ml occurred in 39 , stroke in 60 , and cardiovascular death in 33 patients . Results Sedentary individuals ( n = 212 ) had , compared with those physically active ( n = 511 ) , higher heart rate ( P weight ( P body surface area ( P = 0.02 ) , body mass index ( P LV mass ( LVM , P = 0.04 ) , LVM indexed for height or body surface area ( P = 0.004 ) ; thicker ventricular septum ( P = 0.012 ) and posterior wall ( P = 0.016 ) ; and larger left atrium ( P = 0.006 ) . Systolic variables did not differ . In Cox regression analysis , physically active compared with sedentary patients had lower risk of primary composite endpoint [ odds ratio ( OR ) : 0.42 , 95 % confidence interval ( CI ) : 0.26 - 0.68 , P ] , cardiovascular death ( OR : 0.50 , 95 % CI : 0.22 - 0.1.10 , NS ) , and stroke ( OR : 0.26 , 95 % CI : 0.13 - 0.49 , P for Ml ( OR : 0.79 , 95 % CI : 0.35 - 1.75 , NS ) independent of systolic blood pressure , LVM index , or treatment . Conclusion In hypertensive patients with LVH , physically active patients had improved prognosis for cardiovascular endpoints , mortality , and stroke that was independent of LVM . Eur J Cardiovasc Prev Rehabil 16:242 - 248 © 2009 The European Society of",
"BACKGROUND Regular exercise has been associated in prospect i ve studies with reduced incidence of cardiovascular disease ( CVD ) and death . OBJECTIVE To assess in a cohort study whether there is a similar protective effect of regular exercise among hypertensive individuals . DESIGN Population -based prospect i ve cohort study . Spare time physical activity was assessed by structured interview . SETTING Malmo , Sweden . PARTICIPANTS Healthy men ( n = 642 ) born in 1914 . A baseline examination took place in 1969 - 1970 . MAIN OUTCOME MEASURES All-cause and cardiovascular mortality rates during 25 years of follow-up in relation to blood pressure and other risk factors for atherosclerosis . RESULTS One-hundred ( 16 % ) men reported vigorous spare time physical activity . In this group , 31 had hypertension ( blood pressure > 160/95 mm Hg or treatment for hypertension ) , 47 were smokers and 39 had hyperlipidaemia . Among the 173 men with hypertension , vigorous physical activity was associated with markedly reduced rates of all-cause ( 17.3 versus 40.0 deaths per 1000 person-years ) and cardiovascular mortality ( 6.3 versus 21.0 deaths per 1000 person-years ) . The risk reductions associated with exercise remained statistically significant after adjustment for smoking , systolic blood pressure and antihypertensive therapy . The relative risk was 0.43 ( confidence interval 0.22 - 0.82 ) for total mortality and 0.33 ( confidence interval 0.11 -0.94 ) for CVD mortality . CONCLUSION People who regularly perform physical activity constitute a heterogeneous group with regard to their exposure to known cardiovascular risk factors . Our results support the view that regular physical activity is associated with a reduced incidence of cardiovascular disease and death and suggest that this protective effect may be enhanced among hypertensive individuals"
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41174376-06ff-11f0-808a-c43d1ab1c353
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STUDY DESIGN Systematic review . OBJECTIVES To establish the effectiveness of school-based spinal health interventions in terms of : 1 ) improving knowledge about the spine/spinal care ; 2 ) changing spinal care behaviors ; and 3 ) decreasing the prevalence of spinal pain . SUMMARY OF BACKGROUND DATA Spinal pain is a significant problem in children and adolescents that has been addressed through school-based spinal health interventions . No systematic review has been carried out on this topic to date . METHODS A systematic literature review sought studies that evaluated school-based spinal health interventions . Using clearly defined study inclusion criteria , 11 data bases were search ed from their inception to March 2004 . To identify further literature , three relevant journals were h and search ed , reference lists were checked , and authors of included papers were contacted . Two review ers independently appraised the quality of identified papers and extracted data regarding intervention and study characteristics , statistical analyses performed , and study results . Data were examined using a narrative synthesis of results , and the outcomes of interest were considered individually ( knowledge , behaviors , pain prevalence ) . RESULTS Twelve papers were included in this review ; all papers received a " weak " quality rating . Results of these studies indicate that school-based spinal health interventions may be effective in increasing spinal care knowledge and decreasing the prevalence of spinal pain . However , overall the evidence is inconclusive regarding spinal care behaviors . CONCLUSIONS The poor quality of the review ed studies limits the conclusions that can be made regarding the effectiveness of school-based spinal health interventions
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"Study Design . A prevalence survey of 101 r and omly selected elementary schools in the Israel Central District . Objectives . To identify and describe risk factors for low back pain that exist in the elementary school environment . Summary of Background Data . Recent surveys report a high prevalence of low back pain in children and adolescents that increases with age , with a correlation between low back pain in adolescence and that experienced in adulthood . Environmental risk factors have been associated with the development of low back pain in children . Because of the significant amount of time children spend in their school environment , risk factors need to be identified in this environment . Methods . A question naire , completed by school nurses , measured risk factors among 10,000 children in elementary schools in Israel . These included backpack and student weight , the availability of storage facilities , the appropriateness of chair and desk height to student height , seating arrangements during frontal lessons , and physical activity at recess . Results . Between 30 % and 54 % of students carried > 15 % of their body weight . Nearly 15 % of the first grade rs and 20 % of sixth grade rs had inappropriate chairs . In 74 % of the classes , students sat with their side facing the teacher and in 35 % students sat with their backs . In 6 % of schools , no physical activity is offered at recess . Conclusions . Shortcomings were found in all areas investigated . There is an urgent need for health promotion programs to increase awareness and reduce risks in the school environment",
"Study Design . Cross-sectional survey with personal interviews . Objective . To study national differences in subjective health , back pain , and self-perceived disability between the United Kingdom and Germany . Summary of Background Data . Back pain is a leading health problem in most Western population s , causing enormous costs to the national health systems . Different prevalence rates were reported from many countries , but rarely as a result of a direct comparison based on an identical study design . Methods . A total of 6,235 male and female participants 50 to 79 years of age ( population -based stratified r and om sample s ) were recruited in 6 British and 8 German study centers . The interviewer administered st and ardized question naire included a section about presence and severity of back pain . Results . Past and current back pain was more frequent among German participants and different between East and West German centers . The differences in back pain prevalence rates could not be explained by less favorable risk profiles among German respondents . Conclusions . Intercultural differences in perceiving or reporting back pain can be hypothesized as the most likely explanation of the markedly different prevalence rates of the disorder in the United Kingdom and East and West Germany",
"AIMS The School Health and Alcohol Harm Reduction Project ( SHAHRP study ) aim ed to reduce alcohol-related harm in secondary school students . DESIGN The study used a quasi-experimental research design in which r and omly selected and allocated intervention and comparison groups were assessed at eight , 20 and 32 months after baseline . SETTING Metropolitan , government secondary schools in Perth , Western Australia . PARTICIPANTS The sample involved over 2300 students . The retention rate was 75.9 % over 32 months . INTERVENTION The evidence -based intervention , a curriculum programme with an explicit harm minimization goal , was conducted in two phases over a 2-year period . MEASURES Knowledge , attitude , total alcohol consumption , risky consumption , context of use , harm associated with own use and harm associated with other people 's use of alcohol . FINDINGS There were significant knowledge , attitude and behavioural effects early in the study , some of which were maintained for the duration of the study . The intervention group had significantly greater knowledge during the programme phases , and significantly safer alcohol-related attitudes to final follow-up , but both scores were converging by 32 months . Intervention students were significantly more likely to be non-drinkers or supervised drinkers than were comparison students . During the first and second programme phases , intervention students consumed 31.4 % and 31.7 % less alcohol . Differences were converging 17 months after programme delivery . Intervention students were 25.7 % , 33.8 % and 4.2 % less likely to drink to risky levels from first follow-up onwards . The intervention reduced the harm that young people reported associated with their own use of alcohol , with intervention students experiencing 32.7 % , 16.7 % and 22.9 % less harm from first follow-up onwards . There was no impact on the harm that students reported from other people 's use of alcohol . CONCLUSIONS The results of this study support the use of harm reduction goals and classroom approaches in school drug education",
"OBJECTIVES To determine the prevalence ranges of low back pain ( LBP ) together with any related disability in Australian adults . DESIGN A population -based survey . METHODS The survey was mailed in June 2001 to a stratified r and om sample of 3000 Australian adults selected from the Electoral Roll . Demographic variables of respondents were compared with the Australian population . Selective response bias was investigated using wave analysis . A range of prevalence data was derived , as were disability scores using the Chronic Pain Grade . RESULTS There was a 69 % response rate . There was little variation between the sample and the Australian adult population . There was no significant selective response bias found . The sample point prevalence was estimated at 25.6 % ( 95 % confidence interval [ CI ] , 23.6 - 27.5 ) , 12-month prevalence was 67.6 % ( 95 % CI , 65.5 - 69.7 ) , and lifetime prevalence was 79.2 % , ( 95 % CI , 77.3 - 81.0 ) . In the previous 6-month period , 42.6 % ( 95 % CI , 40.4 - 44.8 ) of the adult population had experienced low-intensity pain and low disability from it . Another 10.9 % ( 95 % CI , 9.6 - 12.3 ) had experienced high intensity-pain but still low disability from this pain . However , 10.5 % ( 95 % CI , 9.2 - 11.9 ) had experienced high-disability LBP . CONCLUSION LBP is a common problem in the Australian adult population , yet most of this is low-intensity and low-disability pain . Nevertheless , over 10 % had been significantly disabled by LBP in the past 6 months . Data from this study will provide a better underst and ing of the magnitude of the LBP problem in Australia , the need for access to health care re sources , and also strategic research directions",
"Abstract . There is increasing evidence that non-specific low back pain ( LBP ) is common among children and adolescents , but there are few longitudinal studies on this subject . This is a longitudinal prospect i ve study aim ed at finding factors associated with the prediction of low back pain in schoolchildren aged 9–12 years , which is a younger age group than has previously been studied . This study was performed on school children in the city of Antwerp , Belgium . A total of 287 children filled out a question naire and were examined at the beginning of the study ( T1 ) and 2 years later ( T2 ) . The question naire asked about back pain , general health , health perceptions , quality of life perceptions , sports , leisure , daily life , school life ( weight of satchel ... ) and some issues related to parents ( smoking , LBP ) . The question naire reliability was tested . Logistic regression was used to analyse the data . No predictors for LBP in children could be identified . Using logistic regression techniques , we analysed the children who reported no lifetime episode of LBP at both T1 and T2 , the children who did report a lifetime episode at both T1 and T2 and also those who reported a history of LBP at T2 only ( New LBP ) . At T2 there were 51 children ( 17.8 % ) reporting suffering at least one lifetime episode of LBP who had not reported such an episode at T1 . Only one parameter showed a statistical difference : New LBP was observed significantly more frequently in children who do not walk to school ( P children who had reported a history of LBP at T1 did not do so at T2 . It may be that LBP in children is so benign and its natural history so favourable that the memory of the episode fades away . It is extremely interesting to note that among the few significant variables , those related to general well-being and self-perception of health , are prominent . It appears , therefore , that psychological factors play a role in the experience of LBP in a similar way to what has been reported in adults . Poor self-perception of health ( health belief ) could be a factor behind the reporting of LBP . Some variables linked to consequences of LBP ( absence from school or from gym and visit to a doctor ) play a significant role in reporting LBP , which suggests that those \" health care \" factors may reinforce a feeling of disease severity",
"STUDY DESIGN A prospect i ve study of personal risk factors for first-time low back pain . OBJECTIVES To construct and vali date a multivariate model to predict low back pain . SUMMARY OF BACKGROUND DATA Various physical and psychological factors have been reported to increase the risk of low back pain , but conflicting results may be attributable to inaccurate \" clinical \" measures and to poorly vali date d statistical models . METHODS A total of 403 health care workers aged 18 - 40 years volunteered for the study . None had any history of \" serious \" back pain requiring medical attention or time off work . The volunteers completed the following question naires : the modified somatic perception question naire , the Zung depression scale , and the Health Locus of Control . Anthropometric factors were quantified using st and ard techniques . The 3Space Isotrak device ( Polhemus , VT ) was used to measure lumbar curvature and hip and lumbar spine mobility . Leg and back strength and back muscle fatiguability were measured in functional postures . Postal follow-up question naires , sent after 6 , 12 , 18 , 24 , 30 , and 36 months , inquired about back pain , and multivariate logistic regression was used to identify risk factors at each follow-up . RESULTS The response rate fell from 99 % at 12 months to 90 % at 36 months , at which time 90 volunteers reported \" serious \" back pain and 266 reported \" any \" back pain . The following were consistent predictors of serious back pain : reduced range of lumbar lateral bending , a long back , reduced lumbar lordosis , increased psychological distress , and previous nonserious low back pain . Only the latter three were consistent predictors of \" any \" back pain . Physical factors had the most influence in a sub- population of volunteers who were new to the job . CONCLUSIONS Personal risk factors explained up to 12 % of first-time low back pain",
"PURPOSE The effect of education on proper wearing of a backpack was studied to determine whether or not a middle school population would improve posture during load carriage by maintaining a more natural posture and to determine if schoolchildren would comply with proper backpack wearing . METHOD 17 middle school children with a mean age of 12.7 years were r and omized into control and intervention groups . Participants were videotaped in four conditions from an anterior view and from a lateral view . Members of both groups participated in Sessions A and C , which consisted of videotaping of the four conditions . Intervention members additionally participated in Session B , consisting of education on how to wear a backpack properly . All participants were interviewed concerning their participation and its effect on how they wore their backpack . Video footage was analyzed to calculate the change in skeletal angles as a result of different methods of load carriage . Interview data was coded and analyzed . RESULTS No quantitative significance was found between control and intervention groups in regards to education on proper backpack wearing improving posture . Interviews revealed that intervention group members benefited from the education on proper wearing of a backpack . 87.5 % of the intervention group members proceeded to continue wearing the backpack properly after the education intervention . CONCLUSIONS Education regarding proper wearing of a backpack may impact the middle school aged child by improving quality of life as noted through decrease in reports of musculoskeletal pain by participants",
"This r and omized controlled trial evaluated the effectiveness of a multicomponent Health Promoting Schools ( HPS ) intervention program in improving self-reported smoking outcomes among a cohort of adolescents in 22 public secondary schools in the Hunter Region of New South Wales , Australia . Pre-test surveys were completed by students in the first 2 years of secondary school , with a 2-year post-test survey . Multivariate analyses examined intervention effect for the main outcome , post-test smoking behavior , controlling for pre-test smoking status , school and other confounders . The sample comprised the cohort of 1852 students who completed both surveys . The results demonstrated that the HPS program failed to improve smoking behavior over the 2 years ( equal increase of 10 % in both groups ) . The program was successful in improving smoking knowledge , but not attitudes , in intervention versus control group ( P pre-test smoking [ odds ratio ( OR ) = 5.44 ; 95 % confidence interval ( CI ) = 3.20 - 9.28 ] , being female ( OR = 0.55 ; CI = 0.35 - 0.87 ) , having more close friends who smoked ( OR = 1.42 ; CI = 1.33 - 1.52 ) , peer group having no clear opinion about smoking ( OR = 3.23 ; CI = 1.27 - 8.27 ) , having more positive and less negative attitudes towards smoking , and being less involved in school activities . We discuss method ological issues in multicomponent community-based interventions , and highlight the strengths and limitations of this study",
"BACKGROUND Nonspecific back pain in children is nearly as common as in adults but is associated with a number of age-specific risk factors including female gender , a family history of low back pain , a high level of physical activity , and prolonged sitting . OBJECTIVE To investigate potential school-related risk factors for back pain in children , most notably schoolbag weight expressed as a percentage of body weight ( relative schoolbag weight ) , whether the schoolbag is carried by h and or by a shoulder harness , how the child travels to and from school , and sitting positions . PATIENTS AND METHODS 123 eighth- grade rs , 58 girls and 65 boys , with a mean age of 14 + /- 0.6 years , completed an anonymous self- question naire during a school day involving six hours of classes . Their schoolbag was weighed on the same day . RESULTS Most respondents traveled to and from school in a vehicle ( 70 % ) , made one trip in each direction each day ( 75 % ) , and carried their schoolbag by the shoulder harness ( 92 % ) . The prevalence of back pain on the study day was 27.6 % , whereas the cumulative prevalence for the last 12 months was 82.9 % with 16.3 % of respondents reporting a single episode of pain , 57.7 % recurrent pain , and 8.9 % chronic pain . A need for a physician visit for back pain was reported in 18.7 % of cases , and 14.6 % of respondents had missed school and /or sporting activities because of back pain . Female gender was associated with current back pain ( odds ratio [ OR ] , 2.7 ; 95 % confidence interval [ CI ] , 1.2 - 6.1 ) . A relative schoolbag weight of 20 % or more was associated with a history of back pain ( OR , 3.1 ; 95 % CI , 1.0 - 9.2 ) , and this effect was larger in children who traveled to and from school on foot and in those who carried their schoolbag in their h and . Sitting on the edge of the chair while completing the question naire was significantly associated with a history of a physician visit for back pain ( OR , 3.1 ; 95 % CI , 1.0 - 9.5 ) . Neither h and edness nor the position of the question naire on the table were significantly associated with back pain in our study population . CONCLUSIONS The findings from this cross-sectional study indicate a need for a longitudinal prospect i ve study design ed to identify etiologic and prognostic factors of back pain in adolescents , with the goal of devising preventive strategies likely to reduce the risk of low back pain in adulthood",
"This paper describes the development , implementation and evaluation of a school- and family-based intervention to prevent obesity in children aged 5 - 7 years . In addition , the efficacy of three different intervention programmes was compared . Children aged 5 - 7 years ( n=213 ) were recruited from three primary schools in Oxford and r and omly allocated to a control group or one of three intervention groups : nutrition group , physical activity group , and combined nutrition and physical activity group . The setting for the interventions was lunchtime clubs , where an interactive and age-appropriate nutrition and /or physical activity curriculum was delivered . The intervention lasted for 20 weeks over four school terms ( approximately 14 months ) . Children 's growth , nutrition knowledge , diet and physical activity were assessed at baseline and at the end of the intervention . Significant improvements in nutrition knowledge were seen in all children ( p fruit and vegetable intake increased significantly ( p rates of overweight and obesity were seen as a result of the intervention . Gender differences were not detected in the majority of assessment s and there was no clear effect of programme type per se . This pilot study has demonstrated that school may be a suitable setting for the promotion of healthy lifestyles in children , but requires replication in other social setting s. Future initiatives should be long-lasting , multi-faceted and sustainable , involving all children in a school , and should target the whole environment and be behaviourally focused . The ultimate goal of any such programme is to lead to positive behaviour change which will have a beneficial effect on long-term health . Successful targeting of the family remains a challenge to such interventions",
"Study Design . This was a prospect i ve 3-year follow-up study of r and omized matched subgroups of 15-year-old school children with or without low back pain initially . Objective . In addition to low back pain and leisure time physical activity , spinal mobility , trunk muscle strength , and early degenerative findings of the lumbar spine were evaluated . Summary of Background Data . Reliable epidemiologic studies on the prevalence of low back pain and development of early degenerative changes of the lumbar spine in young persons have been sparse . Along with several other characteristics , the relationship of these changes to frequent low back pain in young persons is not known . Methods . After a question naire-based survey was administered , subjects with or without low back pain were examined initially and at follow-up with special reference to leisure time physical activity , anthropometry , spinal mobility , trunk muscle strength , and magnetic resonance imaging findings of the lumbar spine . Results . At baseline and at follow-up , those subjects with initial low back pain were characterized by a low frequency of physical activity and decreased spinal function . During follow-up , the occurrence of disc degeneration increased significantly more in the original group with low back pain than among asymptomatic subjects . Furthermore , disc degeneration at baseline significantly predicted future frequent low back pain . Initial disc protrusion also predicted future frequent low back pain . Conclusion . After the rapid physical growth period , there seemed to be a causal relationship between the early evolution of the degenerative processes of the lower lumbar discs and frequent low back pain in several subjects",
"Study Design . A quasi-experimental study with 3 × 4 design was performed . Objective . To improve the level of knowledge and motor skills and thereby avert the development of painful symptoms . Summary of Background Data . Despite the fact that low back pain affects a high percentage of the population , little research has been carried out to prevent low back pain through health education . Methods . The participants in this study were 106 third- grade ( 9-year-old ) students . The program included 11 sessions . The teacher attended the placebo group sessions . No intervention was used with the control group . Results . The level of knowledge and motor skills in the experimental group showed a significant increase immediately after the intervention finished , and at 6- and 12-month intervals after completion of the postural hygiene program ( P = 0.00 ) . Some positive changes were generalized to natural situations ( P = 0.00 ) . In an independent health check carried out by the local school health services 4 years after application of the postural hygiene program , the results tended slightly to favor the experimental condition over the control conditions ( placebo + no intervention ) . A greater number of the control subjects required medical treatment for low back pain , although this difference was only marginally significant ( P = 0.07 ) . Conclusions . The findings from this study support the hypothesis that programs involving practice and motivating strategies impart health knowledge and habits more efficiently than those restricted to the mere transmission of information",
"A back education program for Belgian elementary school children was evaluated using self-reported question naires before intervention and at three follow-up points during one year . Most children found the program interesting , important , and amusing . Intervention children ( n = 347 ) showed better back care knowledge than control children ( n = 359 ) , and knowledge gained was retained over a period of one year . Back education did not result in increased fear-avoidance beliefs about physical activity , and intervention children reported more checking of their book bag weight than controls at all test moments . Self-reported behavior in relation to posture-related and back care related self-efficacy were affected only minimally by the program , possibly due to poor self-judgment . Involvement , fear-avoidance beliefs , and back care knowledge of teachers and parents of the intervention children showed low correlation with the children 's perceptions and knowledge . Sufficient promise exists to justify further development and evaluation of early back education",
"Study Design . A cross-sectional study comprising the first phase of an ongoing , longitudinal prospect i ve study was conducted . Objective . To investigate the relation between backpack use and back pain in adolescents . Summary of Background Data . The prevalence of nonspecific back pain increases dramatically during adolescence from less than 10 % in the pre – teen-age years up to 50 % in 15- to 16-year-olds . There is widespread concern that heavy backpacks carried by adolescents contribute to the development of back pain . Methods . A total of 1126 children , ages 12 to 18 years , participated by completing a question naire about their health , activities , and backpack use . Each child ’s body weight , height , and backpack weight were measured . A child was classified as having back pain if one or more of the following were reported during the preceding month : neck or back pain that had interfered with school or leisure , neck or back pain with a severity rating of 2 or more on a scale 0 to 10 , a visit to a physician or therapist for neck or back pain , or exemption from physical education or sports because of neck or back pain . Results . Of 1122 backpack users , 74.4 % were classified as having back pain , vali date d by significantly poorer general health , more limited physical functioning , and more bodily pain . As compared with no or low use of backpacks at school , heavy use ( odds ratio , 1.98;P back pain . Female gender and larger body mass index also were significantly associated with back pain . As compared with adolescents who had no back pain , adolescents with back pain carried significantly heavier backpacks that represented a significantly greater percentage of their body weights . Conclusion . The use of backpacks during the school day and backpack weights are independently associated with back pain",
"This study investigated the efficacy of guidelines for a motivated class teacher to enhance the application of back care principles , taught by a physical therapist , in fifth- grade elementary schoolchildren . Testing consisted of a practical test before and a practical test , knowledge test and c and i d camera evaluation 11 weeks after the program . Three groups were compared : an intervention group of 38 pupils , with extra guidelines for the teacher , an intervention group of 48 pupils , without extra guidelines and 34 controls . The intervention plus guidelines group , compared to the intervention group without extra teacher guidelines , obtained significantly higher posttest-pretest gain scores for five of the seven practical test items and scored significantly higher for seven of the nine items of the c and i d camera evaluation . Knowledge test scores did not differ significantly between the two intervention groups . Study results indicate that guidelines to a motivated class teacher improve efficacy of back care education in elementary schoolchildren"
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CONTEXT The most recent summary of the European Association of Urology ( EAU ) guidelines on prostate cancer ( PCa ) was published in 2011 . OBJECTIVE To present a summary of the 2013 version of the EAU guidelines on screening , diagnosis , and local treatment with curative intent of clinical ly organ-confined PCa . EVIDENCE ACQUISITION A literature review of the new data emerging from 2011 to 2013 has been performed by the EAU PCa guideline group . The guidelines have been up date d , and levels of evidence and grade s of recommendation have been added to the text based on a systematic review of the literature , which included a search of online data bases and bibliographic review s. EVIDENCE SYNTHESIS A full version of the guidelines is available at the EAU office or online ( www.uroweb.org ) . Current evidence is insufficient to warrant widespread population -based screening by prostate-specific antigen ( PSA ) for PCa . Systematic prostate biopsies under ultrasound guidance and local anesthesia are the preferred diagnostic method . Active surveillance represents a viable option in men with low-risk PCa and a long life expectancy . A biopsy progression indicates the need for active intervention , whereas the role of PSA doubling time is controversial . In men with locally advanced PCa for whom local therapy is not m and atory , watchful waiting ( WW ) is a treatment alternative to and rogen-deprivation therapy ( ADT ) , with equivalent oncologic efficacy . Active treatment is recommended mostly for patients with localized disease and a long life expectancy , with radical prostatectomy ( RP ) shown to be superior to WW in prospect i ve r and omized trials . Nerve-sparing RP is the approach of choice in organ-confined disease , while neoadjuvant ADT provides no improvement in outcome variables . Radiation therapy should be performed with ≥ 74 Gy in low-risk PCa and 78 Gy in intermediate- or high-risk PCa . For locally advanced disease , adjuvant ADT for 3 yr results in superior rates for disease-specific and overall survival and is the treatment of choice . Follow-up after local therapy is largely based on PSA and a disease-specific history , with imaging indicated only when symptoms occur . CONCLUSIONS Knowledge in the field of PCa is rapidly changing . These EAU guidelines on PCa summarize the most recent findings and put them into clinical practice . PATIENT SUMMARY A summary is presented of the 2013 EAU guidelines on screening , diagnosis , and local treatment with curative intent of clinical ly organ-confined prostate cancer ( PCa ) . Screening continues to be done on an individual basis , in consultation with a physician . Diagnosis is by prostate biopsy . Active surveillance is an option in low-risk PCa and watchful waiting is an alternative to and rogen-deprivation therapy in locally advanced PCa not requiring immediate local treatment . Radical prostatectomy is the only surgical option . Radiation therapy can be external or delivered by way of prostate implants . Treatment follow-up is based on the PSA level
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"BACKGROUND Although there is r and omized evidence that radical prostatectomy improves survival , there are few data on how benefit varies by baseline risk . OBJECTIVE We aim ed to create a statistical model to calculate the decrease in risk of death associated with surgery for an individual patient , using stage , grade , prostate-specific antigen , and age as predictors . DESIGN , SETTING , AND PARTICIPANTS A total of 695 men with T1 or T2 prostate cancer participated in the Sc and inavian Prostate Cancer Group 4 trial ( SPCG-4 ) . INTERVENTION Patients in SPCG-4 were r and omized to radical prostatectomy or conservative management . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Competing risk models were created separately for the radical prostatectomy and the watchful waiting group , with the difference between model predictions constituting the estimated benefit for an individual patient . RESULTS AND LIMITATIONS Individualized predictions of surgery benefit varied widely depending on age and tumor characteristics . At 65 yr of age , the absolute 10-yr risk reduction in prostate cancer mortality attributable to radical prostatectomy ranged from 4.5 % to 17.2 % for low- versus high-risk patients . Little expected benefit was associated with surgery much beyond age 70 . Only about a quarter of men had an individualized benefit within even 50 % of the mean . A limitation is that estimates from SPCG-4 have to be applied cautiously to contemporary patients . CONCLUSIONS Our model suggests that it is hard to justify surgery in patients with Gleason 6 , T1 disease or in those patients much above 70 yr of age . Conversely , surgery seems unequivocally of benefit for patients who have Gleason 8 , or Gleason 7 , stage T2 . For patients with Gleason 6 T2 and Gleason 7 T1 , treatment is more of a judgment call , depending on patient preference and other clinical findings , such as the number of positive biopsy cores and comorbidities",
"BACKGROUND High-intensity focused ultrasound ( HIFU ) is an emerging treatment for select patients with localized prostate cancer ( PCa ) . OBJECTIVES To report the oncologic outcome of HIFU as a primary care option for localized prostate cancer from a multicenter data base . DESIGN , SETTING , AND PARTICIPANTS Patients with localized PCa treated with curative intent and presenting at least a 2-yr follow-up from February 1993 were considered in this study . Previously irradiated patients were excluded from this analysis . In case of any residual or recurrent PCa , patients were systematic ally offered a second session . Kaplan-Meier analysis was performed to determine disease-free survival rates ( DFSR ) . MEASUREMENTS Prostate-specific antigen ( PSA ) , clinical stage , and pathologic results were measured pre- and post-HIFU . RESULTS AND LIMITATIONS A total of 803 patients from six urologic departments met the inclusion criteria . Stratification according to d'Amico 's risk group was low , intermediate , and high in 40.2 % , 46.3 % , and 13.5 % of patients , respectively . Mean follow-up was 42+/-33 mo . Mean PSA nadir was 1.0+/-2.8 ng/ml with 54.3 % reaching a nadir of overall and cancer-specific survival rates at 8 yr were 89 % and 99 % , respectively . The metastasis-free survival rate at 8 yr was 97 % . Initial PSA value and Gleason score value significantly influence the DFSR . The 5- and 7-yr biochemical-free survival rates ( Phoenix criteria ) were 83 - 75 % , 72 - 63 % , and 68 - 62 % ( p=0.03 ) and the additional treatment-free survival rates were 84 - 79 % , 68 - 61 % , and 52 - 54 % ( p PSA nadir was a major predictive factor for HIFU success : negative biopsies , stable PSA , and no additional therapy . CONCLUSIONS Local control and DFSR achieved with HIFU were similar to those expected with conformal external-beam radiation therapy ( EBRT ) . The excellent cancer-specific survival rate is also explained by the possibility to repeat HIFU and use salvage EBRT",
"3 Background : Radiotherapy ( RT ) and long term and rogen blockade ( AB ) is st and ard treatment for patients with high risk prostate cancer . However , the optimal duration of AB is not yet defined . The purpose of this r and omized study was to compare outcomes between 36 vs. 18 months of AB in high risk prostate cancer treated with RT ( PCS IV trial , Clinical Trials.gov , # NCT00223171 ) . METHODS PCS IV r and omized patients with node negative high risk prostate cancer ( T3 - 4 , PSA > 20 ng/ml or Gleason score > 7 ) , to pelvic RT ( whole pelvis 44 Gy/4 ½ weeks , prostate 70 Gy/7 weeks ) and 36 ( arm 1 ) vs. 18 months ( arm 2 ) of AB ( neo adjuvant , concomitant , adjuvant ) . AB consisted of bicalutamide 50 mg for one month plus goserelin 10.8 mg every three months for 36 vs. 18 months . Overall survival was the primary end point . Overall and cancer specific survival rates were compared between arms with Kaplan-Meier log rank test and Cox regression . RESULTS From October 2000 to January 2008 , 310 patients were r and omized to arm 1 and 320 to arm 2 . Patients ' characteristics were well balanced between the two arms ( median age 71 years , median PSA 16 ng/ml , median Gleason score 8) . Most patients had T2 - 3 disease . At a median follow-up of 77 months , 71/310 patients ( 22.9 % ) in arm 1 and 76/320 ( 23.8 % ) in arm 2 had died ( p=0.802 ) . Overall , 116 patients died of causes other than prostate cancer . Overall and cancer specific survival hazard ratios were 1.15 ( 0.83 - 1.59 ) , p=0.398 and 1.13 ( 0.61 - 2.08 ) , p=0.153 , respectively . 5 year overall and disease specific survival rates were 92.1 % ( 89.1 - 95.1 ) vs. 86.8 % ( 83.0 - 90.6 ) , p=0.052 and 97.6 % ( 95.9 - 99.4 ) vs. 96.4 % ( 94.2 - 98.6 ) , p=0.473 and 10 year overall and disease specific survival rates were 63.6 % ( 55.7 - 71.5 ) vs. 63.2 % ( 54.7 - 71.7 ) , p=0.429 and 87.2 % ( 81.0 - 93.3 ) vs. 87.2 % ( 80.9 - 93.6 ) , p=0.838 for arm 1 and arm 2 , respectively . There were no significant differences in the rates of biochemical , regional or distant failure between arms . CONCLUSIONS Our study shows that long term AB can be safely reduced from 36 to 18 months without compromising outcomes . Analysis of treatment impact on quality of life is now under review . SOURCE OF FUNDING AstraZeneca Pharmaceuticals Grant . CLINICAL TRIAL INFORMATION Clinical Trials.gov , # NCT00223171",
"BACKGROUND Several trials evaluating the effect of prostate-specific antigen ( PSA ) testing on prostate-cancer mortality have shown conflicting results . We up date d prostate-cancer mortality in the European R and omized Study of Screening for Prostate Cancer with 2 additional years of follow-up . METHODS The study involved 182,160 men between the ages of 50 and 74 years at entry , with a predefined core age group of 162,388 men 55 to 69 years of age . The trial was conducted in eight European countries . Men who were r and omly assigned to the screening group were offered PSA-based screening , whereas those in the control group were not offered such screening . The primary outcome was mortality from prostate cancer . RESULTS After a median follow-up of 11 years in the core age group , the relative reduction in the risk of death from prostate cancer in the screening group was 21 % ( rate ratio , 0.79 ; 95 % confidence interval [ CI ] , 0.68 to 0.91 ; P=0.001 ) , and 29 % after adjustment for noncompliance . The absolute reduction in mortality in the screening group was 0.10 deaths per 1000 person-years or 1.07 deaths per 1000 men who underwent r and omization . The rate ratio for death from prostate cancer during follow-up years 10 and 11 was 0.62 ( 95 % CI , 0.45 to 0.85 ; P=0.003 ) . To prevent one death from prostate cancer at 11 years of follow-up , 1055 men would need to be invited for screening and 37 cancers would need to be detected . There was no significant between-group difference in all-cause mortality . CONCLUSIONS Analyses after 2 additional years of follow-up consoli date d our previous finding that PSA-based screening significantly reduced mortality from prostate cancer but did not affect all-cause mortality . ( Current Controlled Trials number , IS RCT N49127736 . )",
"BACKGROUND The optimal upper limit of the normal range for prostate-specific antigen ( PSA ) is unknown . We investigated the prevalence of prostate cancer among men in the Prostate Cancer Prevention Trial who had a PSA level of 4.0 ng per milliliter or less . METHODS Of 18,882 men enrolled in the prevention trial , 9459 were r and omly assigned to receive placebo and had an annual measurement of PSA and a digital rectal examination . Among these 9459 men , 2950 men never had a PSA level of more than 4.0 ng per milliliter or an abnormal digital rectal examination , had a final PSA determination , and underwent a prostate biopsy after being in the study for seven years . RESULTS Among the 2950 men ( age range , 62 to 91 years ) , prostate cancer was diagnosed in 449 ( 15.2 percent ) ; 67 of these 449 cancers ( 14.9 percent ) had a Gleason score of 7 or higher . The prevalence of prostate cancer was 6.6 percent among men with a PSA level of up to 0.5 ng per milliliter , 10.1 percent among those with values of 0.6 to 1.0 ng per milliliter , 17.0 percent among those with values of 1.1 to 2.0 ng per milliliter , 23.9 percent among those with values of 2.1 to 3.0 ng per milliliter , and 26.9 percent among those with values of 3.1 to 4.0 ng per milliliter . The prevalence of high- grade cancers increased from 12.5 percent of cancers associated with a PSA level of 0.5 ng per milliliter or less to 25.0 percent of cancers associated with a PSA level of 3.1 to 4.0 ng per milliliter . CONCLUSIONS Biopsy-detected prostate cancer , including high- grade cancers , is not rare among men with PSA levels of 4.0 ng per milliliter or less -- levels generally thought to be in the normal range",
"PURPOSE Active surveillance for favorable risk prostate cancer is an approach that may reduce the risk of overtreatment of clinical ly insignificant prostate cancer . In fact , some patients with favorable risk disease at diagnosis harbor more aggressive disease and may be at risk for prostate cancer mortality despite close monitoring . This is a detailed report of 5 of 453 patients on surveillance who died of prostate cancer . MATERIAL S AND METHODS A large phase 2 prospect i ve trial of active surveillance in patients with favorable risk prostate cancer was initiated in 1995 . Eligible patients had favorable risk prostate cancer ( prostate specific antigen 10 ng/ml or less , Gleason 6 or less , T1c/T2a ) . Epstein criteria for clinical ly insignificant prostate cancer ( a third or less of cores positive , 50 % or less involvement of any 1 core , and prostate specific antigen density less than 0.15 ) were used for men younger than 55 years . Patients were followed with serial prostate specific antigen determinations every 3 months for 2 years and then every 6 months if stable . Biopsies were performed at 1 year and then every 3 to 4 years . Radical intervention was offered if prostate specific antigen doubling time was less than 3 years or Gleason 3 + 4 pattern disease was identified on repeat biopsy . For the first 5 years of the study patients older than 70 years were eligible if they had Gleason 3 + 4 or less , or prostate specific antigen less than 15 ng/ml . RESULTS The rate of intervention with radiation or surgery was 38 % at 10 years ( actuarial ) . All 5 patients had a prostate specific antigen doubling time of 1.6 years or less triggering a recommendation of radical therapy . Radical intervention was performed in 3 of the 5 patients . Patients 1 and 4 received radiation and patient 3 underwent radical prostatectomy . Of the 2 patients who did not receive definitive treatment 1 was lost to followup ( patient 2 ) and was treated conservatively by his family doctor . Patient 5 elected and rogen deprivation therapy rather than radical treatment . CONCLUSIONS The low prostate cancer mortality in our surveillance cohort provides support for an active surveillance approach to favorable risk prostate cancer . Only 1 of the 5 patients presented with favorable disease and experienced a theoretically preventable death . The absence of preventable deaths suggests that the basic approach is sound . Two patients had a trigger for intervention but did not receive it . This reinforces the importance of close monitoring and of definitive treatment for those in whom disease is reclassified as higher risk over time",
"In the Sc and inavian Prostate Cancer Group Trial Number 4 ( SPCG-4 ) , 347 men were r and omly assigned to radical prostatectomy and 348 to watchful waiting . In the most recent analysis ( median follow-up time = 12.8 years ) , the cumulative mortality curves had been stable over the follow-up . At 15 years , the absolute risk reduction of dying from prostate cancer was 6.1 % following r and omization to radical prostatectomy , compared with watchful waiting . Hence , 17 need to be r and omized to operation to avert one death . Data on self-reported symptoms , stress from symptoms , and quality of life were collected at 4 and 12.2 years of median follow-up . These question naire studies show an intricate pattern of symptoms evolving after surgery , hormonal treatments , signs of tumor progression , and also from natural aging . This article discusses some of the main findings of the SPCG-4 study",
"BACKGROUND Previous r and omised trials demonstrated that adjuvant radiation therapy ( aRT ) improves cancer control in patients with pT3 prostate cancer ( PCa ) . However , there is currently no evidence supporting early salvage radiation therapy ( eSRT ) as equivalent to aRT in improving freedom from biochemical recurrence ( BCR ) after radical prostatectomy ( RP ) . OBJECTIVE To evaluate BCR-free survival for aRT versus observation followed by eSRT in cases of relapse in patients undergoing RP for pT3pN0 , R0-R1 PCa . DESIGN , SETTING , AND PARTICIPANTS Using a European multi-institutional cohort , 890 men with pT3pN0 , R0-R1 PCa were identified . INTERVENTION All patients underwent RP . Subsequently , patients were stratified into two groups : aRT versus initial observation followed by eSRT in cases of relapse . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES : Propensity-matched analysis was employed , and patients were stratified into two groups : aRT versus observation and eventual eSRT , defined as RT given at a postoperative serum prostate-specific antigen ( PSA ) ≤ 0.5 ng/ml at least 6 mo after RP . BCR , defined as PSA > 0.20 ng/ml and rising after administration of RT , was compared between aRT and initial observation followed by eSRT in cases of relapse using Kaplan-Meier and Cox regression methods . RESULTS AND LIMITATIONS Overall , 390 ( 43.8 % ) and 500 ( 56.2 % ) patients were treated with aRT and initial observation , respectively . Within the latter group , 225 ( 45.0 % ) patients experienced BCR and underwent eSRT . In the postpropensity-matched cohort , the 2- and 5-yr BCR-free survival rates were 91.4 % and 78.4 % in aRT versus 92.8 % and 81.8 % in patients who underwent initial observation and eSRT in cases of relapse , respectively ( p=0.9 ) . No differences in the 2- and 5-yr BCR-free survival rates were found , even when patients were stratified according to pT3 substage and surgical margin status ( all p ≥ 0.4 ) . These findings were also confirmed in multivariable analyses ( p=0.6 ) . Similar results were achieved when the cut-off to define eSRT was set at 0.3 ng/ml ( all p ≥ 0.5 ) . CONCLUSIONS The current study suggests that timely administration of eSRT is comparable to aRT in improving BCR-free survival in the majority of pT3pN0 PCa patients . Therefore , eSRT may not compromise cancer control but significantly reduces overtreatment associated with aRT",
"BACKGROUND The effectiveness of surgery versus observation for men with localized prostate cancer detected by means of prostate-specific antigen ( PSA ) testing is not known . METHODS From November 1994 through January 2002 , we r and omly assigned 731 men with localized prostate cancer ( mean age , 67 years ; median PSA value , 7.8 ng per milliliter ) to radical prostatectomy or observation and followed them through January 2010 . The primary outcome was all-cause mortality ; the secondary outcome was prostate-cancer mortality . RESULTS During the median follow-up of 10.0 years , 171 of 364 men ( 47.0 % ) assigned to radical prostatectomy died , as compared with 183 of 367 ( 49.9 % ) assigned to observation ( hazard ratio , 0.88 ; 95 % confidence interval [ CI ] , 0.71 to 1.08 ; P=0.22 ; absolute risk reduction , 2.9 percentage points ) . Among men assigned to radical prostatectomy , 21 ( 5.8 % ) died from prostate cancer or treatment , as compared with 31 men ( 8.4 % ) assigned to observation ( hazard ratio , 0.63 ; 95 % CI , 0.36 to 1.09 ; P=0.09 ; absolute risk reduction , 2.6 percentage points ) . The effect of treatment on all-cause and prostate-cancer mortality did not differ according to age , race , coexisting conditions , self-reported performance status , or histologic features of the tumor . Radical prostatectomy was associated with reduced all-cause mortality among men with a PSA value greater than 10 ng per milliliter ( P=0.04 for interaction ) and possibly among those with intermediate-risk or high-risk tumors ( P=0.07 for interaction ) . Adverse events within 30 days after surgery occurred in 21.4 % of men , including one death . CONCLUSIONS Among men with localized prostate cancer detected during the early era of PSA testing , radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality , as compared with observation , through at least 12 years of follow-up . Absolute differences were less than 3 percentage points . ( Funded by the Department of Veterans Affairs Cooperative Studies Program and others ; PIVOT Clinical Trials.gov number , NCT00007644 . )",
"BACKGROUND Several studies have shown the efficacy of endocrine therapy in combination with radiotherapy in high-risk prostate cancer . To assess the effect of radiotherapy , we did an open phase III study comparing endocrine therapy with and without local radiotherapy , followed by castration on progression . METHODS This r and omised trial included men from 47 centres in Norway , Sweden , and Denmark . Between February , 1996 , and December , 2002 , 875 patients with locally advanced prostate cancer ( T3 ; 78 % ; PSA were central ly r and omly assigned by computer to endocrine treatment alone ( 3 months of total and rogen blockade followed by continuous endocrine treatment using flutamide ; 439 patients ) , or to the same endocrine treatment combined with radiotherapy ( 436 patients ) . The primary endpoint was prostate-cancer-specific survival , and analysis was by intention to treat . This study is registered as an international st and ard r and omised controlled trial , number IS RCT N01534787 . FINDINGS After a median follow-up of 7.6 years , 79 men in the endocrine alone group and 37 men in the endocrine plus radiotherapy group had died of prostate cancer . The cumulative incidence at 10 years for prostate-cancer-specific mortality was 23.9 % in the endocrine alone group and 11.9 % in the endocrine plus radiotherapy group ( difference 12.0 % , 95 % CI 4.9 - 19.1 % ) , for a relative risk of 0.44 ( 0.30 - 0.66 ) . At 10 years , the cumulative incidence for overall mortality was 39.4 % in the endocrine alone group and 29.6 % in the endocrine plus radiotherapy group ( difference 9.8 % , 0.8 - 18.8 % ) , for a relative risk of 0.68 ( 0.52 - 0.89 ) . Cumulative incidence at 10 years for PSA recurrence was substantially higher in men in the endocrine-alone group ( 74.7%vs 25.9 % , p urinary , rectal , and sexual problems were slightly more frequent in the endocrine plus radiotherapy group . INTERPRETATION In patients with locally advanced or high-risk local prostate cancer , addition of local radiotherapy to endocrine treatment halved the 10-year prostate-cancer-specific mortality , and substantially decreased overall mortality with fully acceptable risk of side-effects compared with endocrine treatment alone . In the light of these data , endocrine treatment plus radiotherapy should be the new st and ard",
"Prostate biopsy is usually performed without anesthesia . We evaluated the patient ’s perception of pain/discomfort experienced during the procedure in terms of the type of anesthesia used : periprostatic infiltration with 2 % lidocaine , or intrarectal instillation of lidocaine-prilocain cream . A total of 198 patients were divided into three groups : group 1 ( control group , n=40 ) received sonographic gel intrarectally prior to biopsy , group 2 ( n=75 ) were given intrarectal instillation of lidocaine-prilocain cream , and group 3 ( n=80 ) received periprostatic anesthesia by injecting 10 ml of 2 % lidocaine . Pain after each biopsy was assessed using an 11-point linear visual analog pain scale . The mean pain scores were 5.1 in group 1 , 4.8 in group 2 , and 2.5 in group 3 , result ing in a significant difference between group 3 and both groups 1 and 2 , but not between groups 1 and 2 . The incidence of biopsy-related adverse events did not differ among groups . Transrectal ultrasonographic guided periprostatic anesthesia is superior to intarectal instillation of lidocaine-prilocain cream",
"BACKGROUND Composite endpoints can be problematic in the presence of competing risks when a treatment does not affect events comprising the endpoint equally . METHODS We conducted secondary analysis of SWOG 8794 trial of adjuvant radiation therapy ( RT ) for high-risk post-operative prostate cancer . The primary outcome was metastasis-free survival ( MFS ) , defined as time to first occurrence of metastasis or death from any cause ( competing mortality ( CM ) ) . We developed separate risk scores for time to metastasis and CM using competing risks regression . We estimated treatment effects using Cox models adjusted for risk scores and identified an enriched subgroup of 75 patients at high risk of metastasis and low risk of CM . RESULTS The mean CM risk score was significantly lower in the RT arm vs. control arm ( p=0.001 ) . The effect of RT on MFS ( HR 0.70 ; 95 % CI , 0.53 - 0.92 ; p=0.010 ) was attenuated when controlling for metastasis and CM risk ( HR 0.76 ; 95 % CI , 0.58 - 1.00 ; p=0.049 ) , and the effect of RT on overall survival ( HR 0.73 ; 95 % CI , 0.55 - 0.96 ; p=0.02 ) was no longer significant when controlling for metastasis and CM risk ( HR 0.80 ; 95 % CI , 0.60 - 1.06 ; p=0.12 ) . Compared to the whole sample , the enriched subgroup had the same 10-year incidence of MFS ( 40 % ; 95 % CI , 22 - 57 % ) , but a higher incidence of metastasis ( 30 % ( 95 % CI , 15 - 47 % ) vs. 20 % ( 95 % CI , 15 - 26 % ) ) . A r and omized trial in the subgroup would have achieved 80 % power with 56 % less patients ( 313 vs. 709 , respectively ) . CONCLUSION Stratification on competing event risk may improve the efficiency of clinical trials",
"BACKGROUND The effect of screening with prostate-specific-antigen ( PSA ) testing and digital rectal examination on the rate of death from prostate cancer is unknown . This is the first report from the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial on prostate-cancer mortality . METHODS From 1993 through 2001 , we r and omly assigned 76,693 men at 10 U.S. study centers to receive either annual screening ( 38,343 subjects ) or usual care as the control ( 38,350 subjects ) . Men in the screening group were offered annual PSA testing for 6 years and digital rectal examination for 4 years . The subjects and health care providers received the results and decided on the type of follow-up evaluation . Usual care sometimes included screening , as some organizations have recommended . The numbers of all cancers and deaths and causes of death were ascertained . RESULTS In the screening group , rates of compliance were 85 % for PSA testing and 86 % for digital rectal examination . Rates of screening in the control group increased from 40 % in the first year to 52 % in the sixth year for PSA testing and ranged from 41 to 46 % for digital rectal examination . After 7 years of follow-up , the incidence of prostate cancer per 10,000 person-years was 116 ( 2820 cancers ) in the screening group and 95 ( 2322 cancers ) in the control group ( rate ratio , 1.22 ; 95 % confidence interval [ CI ] , 1.16 to 1.29 ) . The incidence of death per 10,000 person-years was 2.0 ( 50 deaths ) in the screening group and 1.7 ( 44 deaths ) in the control group ( rate ratio , 1.13 ; 95 % CI , 0.75 to 1.70 ) . The data at 10 years were 67 % complete and consistent with these overall findings . CONCLUSIONS After 7 to 10 years of follow-up , the rate of death from prostate cancer was very low and did not differ significantly between the two study groups . ( Clinical Trials.gov number , NCT00002540 .",
"Summary Background Whether the addition of radiation therapy ( RT ) improves overall survival in men with locally advanced prostate cancer managed with and rogen deprivation therapy ( ADT ) is unclear . Our aim was to compare outcomes in such patients with locally advanced prostate cancer . Methods Patients with : locally advanced ( T3 or T4 ) prostate cancer ( n=1057 ) ; or organ-confined disease ( T2 ) with either a prostate-specific antigen ( PSA ) concentration more than 40 ng/mL ( n=119 ) or PSA concentration more than 20 ng/mL and a Gleason score of 8 or higher ( n=25 ) , were r and omly assigned ( done central ly with stratification and dynamic minimisation , not masked ) to receive lifelong ADT and RT ( 65–69 Gy to the prostate and seminal vesicles , 45 Gy to the pelvic nodes ) . The primary endpoint was overall survival . The results presented here are of an interim analysis planned for when two-thirds of the events for the final analysis were recorded . All efficacy analyses were done by intention to treat and were based on data from all patients . This trial is registered at controlledtrials.com as IS RCT N24991896 and Clinical trials.gov as NCT00002633 . Results Between 1995 and 2005 , 1205 patients were r and omly assigned ( 602 in the ADT only group and 603 in the ADT and RT group ) ; median follow-up was 6·0 years ( IQR 4·4–8·0 ) . At the time of analysis , a total of 320 patients had died , 175 in the ADT only group and 145 in the ADT and RT group . The addition of RT to ADT improved overall survival at 7 years ( 74 % , 95 % CI 70–78 vs 66 % , 60–70 ; hazard ratio [ HR ] 0·77 , 95 % CI 0·61–0·98 , p=0·033 ) . Both toxicity and health-related quality -of-life results showed a small effect of RT on late gastrointestinal toxicity ( rectal bleeding grade > 3 , three patients ( 0·5 % ) in the ADT only group , two ( 0·3 % ) in the ADT and RT group ; diarrhoea grade > 3 , four patients ( 0·7 % ) vs eight ( 1·3 % ) ; urinary toxicity grade > 3 , 14 patients ( 2·3 % ) in both groups ) . Interpretation The benefits of combined modality treatment — ADT and RT — should be discussed with all patients with locally advanced prostate cancer . Funding Canadian Cancer Society Research Institute , US National Cancer Institute , and UK Medical Research Council",
"BACKGROUND We report the long-term results of a trial of immediate postoperative irradiation versus a wait- and -see policy in patients with prostate cancer extending beyond the prostate , to confirm whether previously reported progression-free survival was sustained . METHODS This r and omised , phase 3 , controlled trial recruited patients aged 75 years or younger with untreated cT0 - 3 prostate cancer ( WHO performance status 0 or 1 ) from 37 institutions across Europe . Eligible patients were r and omly assigned central ly ( 1:1 ) to postoperative irradiation ( 60 Gy of conventional irradiation to the surgical bed for 6 weeks ) or to a wait- and -see policy until biochemical progression ( increase in prostate-specific antigen > 0·2 μg/L confirmed twice at least 2 weeks apart ) . We analysed the primary endpoint , biochemical progression-free survival , by intention to treat ( two-sided test for difference at α=0.05 , adjusted for one interim analysis ) and did exploratory analyses of heterogeneity of effect . This trial is registered with Clinical Trials.gov , number NCT00002511 . FINDINGS 1005 patients were r and omly assigned to a wait- and -see policy ( n=503 ) or postoperative irradiation ( n=502 ) and were followed up for a median of 10·6 years ( range 2 months to 16·6 years ) . Postoperative irradiation significantly improved biochemical progression-free survival compared with the wait- and -see policy ( 198 [ 39·4 % ] of 502 patients in postoperative irradiation group vs 311 [ 61·8 % ] of 503 patients in wait- and -see group had biochemical or clinical progression or died ; HR 0·49 [ 95 % CI 0·41 - 0·59 ] ; p ( any type of any grade ) were more frequent in the postoperative irradiation group than in the wait- and -see group ( 10 year cumulative incidence 70·8 % [ 66·6 - 75·0 ] vs 59·7 % [ 55·3 - 64·1 ] ; p=0.001 ) . INTERPRETATION Results at median follow-up of 10·6 years show that conventional postoperative irradiation significantly improves biochemical progression-free survival and local control compared with a wait- and -see policy , supporting results at 5 year follow-up ; however , improvements in clinical progression-free survival were not maintained . Exploratory analyses suggest that postoperative irradiation might improve clinical progression-free survival in patients younger than 70 years and in those with positive surgical margins , but could have a detrimental effect in patients aged 70 years or older . FUNDING Ligue Nationale contre le Cancer ( Comité de l'Isère , Grenoble , France ) and the European Organisation for Research and Treatment of Cancer ( EORTC ) Charitable Trust",
" A recent r and omized trial to compare external beam radiation therapy ( EBRT ) to cryoablation for localized disease showed cryoablation to be noninferior to external beam EBRT in disease progression and overall and disease‐specific survival . We report on the quality of life ( QOL ) outcomes for this trial",
"PURPOSE Radiation Therapy Oncology Group ( RTOG ) Protocol 92 - 02 was a r and omized trial testing long-term ( LT ) adjuvant and rogen deprivation ( AD ) after initial AD with external-beam radiotherapy ( RT ) in patients with locally advanced prostate cancer ( PC ; T2c-4 ) and with prostate-specific antigen level less than 150 ng/mL. PATIENTS AND METHODS Patients received a total of 4 months of goserelin and flutamide , 2 months before and 2 months during RT . A radiation dose of 65 to 70 Gy was given to the prostate and a dose of 44 to 50 Gy to the pelvic lymph nodes . Patients were r and omly assigned to receive no additional therapy ( short-term [ST]AD-RT ) or 24 months of goserelin ( LTAD-RT ) ; 1,554 patients were entered onto the study . RESULTS The LTAD-RT arm showed significant improvement in all efficacy end points except overall survival ( OS ; 80.0 % v 78.5 % at 5 years , P = .73 ) , compared with the STAD-RT arm . In a subset of patients not part of the original study design , with tumors assigned Gleason scores of 8 to 10 by the contributing institutions , the LTAD-RT arm had significantly better OS ( 81.0 % v 70.7 % , P = .044 ) . There was a small but significant increase in the frequency of late radiation grade s 3 , 4 , and 5 gastrointestinal toxicity ascribed to the LTAD-RT arm ( 2.6 % v 1.2 % at 5 years , P = .037 ) , the cause of which is not clear . CONCLUSION The RTOG 92 - 02 trial supports the addition of LT adjuvant AD to STAD with RT for T2c-4 PC . In the exploratory subset analysis of patients with Gleason scores 8 to 10 , LT adjuvant AD result ed in a survival advantage ",
"OBJECTIVES Transperineal and transrectal prostate biopsy are both used for prostate cancer detection . However , which approach is superior remains unknown . In this study , we performed a prospect i ve r and omized study to compare the efficacy of transperineal versus transrectal 12-core initial prostate biopsy . METHODS From May 2003 to October 2005 , a prospect i ve r and omized study of transperineal versus transrectal 12-core biopsy ( 126 and 120 patients , respectively ) was conducted in 246 patients with a prostate-specific antigen level of 4.0 to 20.0 ng/mL. All procedures were performed with the patient in the lithotomy position , with the transperineal and transrectal approach performed with spinal anesthesia ( 0.5 % bupivacaine ) or a caudal block ( 1 % lidocaine ) , respectively . With both approaches , eight biopsy specimens were obtained systematic ally from the peripheral zone , including the apex , and four from the transition zone . RESULTS The cancer detection rate was 42.1 % ( 53 of 126 patients ) with the transperineal approach and 48.3 % ( 58 of 120 patients ) with the transrectal approach ( P = 0.323 ) . For all patients undergoing transperineal and transrectal biopsy , the cancer core rate ( cancer core number/biopsy core number ) was 13.7 % ( 207 of 1512 cores ) and 14.4 % ( 208 of 1440 cores ) , respectively ( P = 0.566 ) . Apart from headache , presumably related to the spinal anesthesia , no significant differences were found in the complications between the two groups . CONCLUSIONS No significant differences were found in the cancer detection rate , cancer core rate , or complications between the two approaches . We believe that the preferred approach as an initial prostate biopsy is the transrectal approach , which does not require spinal anesthesia or another burdensome process",
"PURPOSE More than 1 million prostate biopsies are performed annually among Medicare beneficiaries . We determined the risk of serious complications requiring hospitalization . We hypothesized that with emerging multidrug resistant organisms there may be an increasing risk of infectious complications . MATERIAL S AND METHODS In a 5 % r and om sample of Medicare participants in SEER ( Surveillance , Epidemiology and End Results ) regions from 1991 to 2007 we compared 30-day hospitalization rates and ICD-9 primary diagnosis codes for admissions between 17,472 men who underwent prostate biopsy and a r and om sample of 134,977 controls . Multivariate logistic and Poisson regression were used to examine the risk and predictors of serious infectious and noninfectious complications with time . RESULTS The 30-day hospitalization rate was 6.9 % within 30 days of prostate biopsy , which was substantially higher than the 2.7 % in the control population . After adjusting for age , race , SEER region , year and comorbidities prostate biopsy was associated with a 2.65-fold ( 95 % CI 2.47 - 2.84 ) increased risk of hospitalization within 30 days compared to the control population ( p risk of infectious complications requiring hospitalization after biopsy was significantly greater in more recent years ( p(trend ) = 0.001 ) . Among men undergoing biopsy , later year , nonwhite race and higher comorbidity scores were significantly associated with an increased risk of infectious complications . CONCLUSIONS The risk of hospitalization within 30 days of prostate biopsy was significantly higher than in a control population . Infectious complications after prostate biopsy have increased in recent years while the rate of serious noninfectious complications is relatively stable . Careful patient selection for prostate biopsy is essential to minimize the potential harms",
"The aim of this study is to eluci date the diagnostic efficacy between transperineal and transrectal 12-core prostate biopsy for prostate cancer . We prospect ively r and omized 200 consecutive men into two groups to undergo systematic prostate biopsy . Overall positivity for cancer was similar ( 47 % by transperineal and 53 % by transrectal ; P=0.480 ) . However , in case with ‘ gray zone ’ PSA ( from 4.1 to 10.0 ng/ml ) , significantly more cores were positive when approach was transperineal , especially among transition zone cores . Therefore , urologist preferences are sufficient for choosing an approach , except for a possible small advantage of transperineal biopsy when PSA is in gray zone",
"PURPOSE To retrospectively determine whether endorectal magnetic resonance ( MR ) imaging findings contribute incremental value to the Kattan nomogram for predicting seminal vesicle invasion ( SVI ) in patients with prostate cancer . MATERIAL S AND METHODS The institutional review board issued a waiver of authorization , which included a waiver of informed consent , for this HIPAA-compliant study . From October 2000 through January 2005 , 573 patients ( mean age , 58.3 years ; age range , 36 - 86 years ) underwent endorectal MR imaging before prostate cancer surgery . The endorectal MR imaging results had been prospect ively interpreted by seven radiologists , and the likelihood of SVI was retrospectively scored on the basis of radiologists ' written reports . MR imaging findings , individual clinical variables ( serum prostate-specific antigen [ PSA ] level , Gleason grade , clinical stage , greatest percentage of cancer in all biopsy cores , percentage of positive cores in all biopsy cores , and perineural invasion ) , and the Kattan nomogram were evaluated with respect to SVI prediction ; surgical pathologic analysis was used as the reference st and ard . Logistic regression and receiver operating characteristic ( ROC ) curve analyses were performed . RESULTS At pathologic analysis , 28 ( 4.9 % ) of 573 patients had SVI . At univariate analysis , endorectal MR imaging results and all clinical variables except the percentage of positive biopsy cores were significantly associated with SVI ( P endorectal MR imaging ( 0.76 ) had a larger area under the ROC curve ( AUC ) than any clinical variable ( 0.62 - 0.73 ) . At multivariate analysis , endorectal MR imaging results , Gleason grade , PSA level , and the percentage of cancer in all biopsy cores were significantly associated with SVI ( P endorectal MR imaging ( 0.87 ) had a significantly larger ( P AUC than either endorectal MR imaging alone ( 0.76 ) or the Kattan nomogram alone ( 0.80 ) . CONCLUSION The addition of endorectal MR imaging contributes significant incremental value to the Kattan nomogram for predicting SVI",
"PURPOSE To assess the benefit and toxicity and quality -of-life ( QOL ) outcomes of pelvic nodes irradiation in nonmetastatic prostate carcinoma patients . PATIENTS AND METHODS Between December 1998 and June 2004 , 444 patients with T1b-T3 , N0 pNx , M0 prostate carcinoma were r and omly assigned to either pelvic and prostate radiotherapy or prostate radiotherapy only . Patients were stratified according to the prognostic factor of lymph node involvement ( LNI ) . Short-term 6-month neoadjuvant and concomitant hormonal therapy was allowed only for patients in the high-risk group . The pelvic dose was 46 Gy . The total dose recommended to the prostate was changed during the course of the study from 66 Gy to 70 Gy . Criteria for progression-free survival ( PFS ) included biologic prostate-specific antigen recurrences or a local or metastatic evolution . Acute and late toxicities were recorded according to the Radiation Therapy Oncology Group and Late Effects in Normal Tissues Subjective , Objective , Management , and Analytic scales , respectively . The QOL outcome was recorded with the European Organisation for Research and Treatment of Cancer Quality of Life Question naire C30 , the International Prostatic Symptom Score , and the Sexual Function Index scales . RESULTS With a 42.1-month median follow-up time , the 5-year PFS and overall survival were similar in the two treatment arms for the whole series and for each stratified group . On multivariate analysis , low LNI risk and hormonal therapy were statistically associated with increased PFS . However , subgroup analyses based on these factors did not show any benefit for pelvic irradiation . There were no significant differences in acute and late digestive toxicities and in QOL outcomes . CONCLUSION Pelvic node irradiation was well tolerated but did not improve PFS",
"PURPOSE A urinary assay for PCA3 , an mRNA that is highly over expressed in prostate cancer cells , has shown usefulness as a diagnostic test for this common malignancy . We further characterized PCA3 performance in different groups of men and determined whether the PCA3 score could synergize with other clinical information to predict biopsy outcome . MATERIAL S AND METHODS Prospect ively urine was collected following st and ardized digital rectal examination in 570 men immediately before prostate biopsy . Urinary PCA3 mRNA levels were quantified and then normalized to the amount of prostate derived RNA to generate a PCA3 score . RESULTS The percent of biopsy positive men identified increased directly with the PCA3 score . PCA3 assay performance was equivalent in the first vs previous negative biopsy groups with an area under the ROC curve of 0.70 and 0.68 , respectively . Unlike serum prostate specific antigen the PCA3 score did not increase with prostate volume . PCA3 assay sensitivity and specificity were equivalent at serum prostate specific antigen less than 4 , 4 to 10 and more than 10 ng/ml . A logistic regression algorithm using PCA3 , serum prostate specific antigen , prostate volume and digital rectal examination result increased the AUC from 0.69 for PCA3 alone to 0.75 ( p = 0.0002 ) . CONCLUSIONS PCA3 is independent of prostate volume , serum prostate specific antigen level and the number of prior biopsies . The quantitative PCA3 score correlated with the probability of positive biopsy . Logistic regression results suggest that the PCA3 score could be incorporated into a nomogram for improved prediction of biopsy outcome . The results of this study provide further evidence that PCA3 is a useful adjunct to current methods for prostate cancer diagnosis",
"OBJECTIVES Controversy exists about the preferred treatment of patients with high-risk or locally advanced prostate cancer . We examined the intermediate-term cancer control and quality -of-life outcomes after radical retropubic prostatectomy ( RRP ) in selected patients . METHODS From 1984 to 2003 , 288 men with Stage cT2b ( Gleason score 8 to 10 or a prostate-specific antigen level greater than 15 ng/mL ) or T3 disease underwent RRP by a single surgeon . The 7 and 10-year actuarial progression-free survival ( PFS ) , cancer-specific survival ( CSS ) , overall survival ( OS ) , potency , and continence rates were recorded . RESULTS The actuarial 7-year PFS , CSS , and OS rate after surgery was 39 % , 92 % , and 91 % , respectively . The corresponding actuarial 10-year rates were 35 % , 88 % , and 74 % . Only OS differed significantly by age group . On multivariate analysis , the pathologic stage was a significant independent predictor of progression . Ultimately , 31 men ( 11 % ) required hormonal therapy , 58 ( 20 % ) underwent postoperative radiotherapy , and 67 ( 23 % ) received both . Potency and continence were preserved in 64 % and 92 % , respectively . CONCLUSIONS Overall , RRP offers excellent intermediate-term cancer control for selected men of all ages who present with high-risk or locally advanced disease . The PFS was significantly greater for men with high-risk Stage cT2b than for those with cT3 disease , but the CSS and OS were similar . Both continence and potency were preserved in most patients , although the potency rates were significantly greater for the younger men . RRP with appropriate postoperative radiotherapy and /or hormonal therapy is a reasonable treatment option for selected men with high-risk or locally advanced disease",
"PURPOSE Local failure after radical prostatectomy ( RP ) is common in patients with cancer extending beyond the capsule . Two r and omized trials demonstrated an advantage for adjuvant radiotherapy ( RT ) compared with a wait- and -see policy . We conducted a r and omized , controlled clinical trial to compare RP followed by immediate RT with RP alone for patients with pT3 prostate cancer and an undetectable prostate-specific antigen ( PSA ) level after RP . METHODS After RP , 192 men were r and omly assigned to a wait- and -see policy , and 193 men were assigned to immediate postoperative RT . Eligible patients had pT3 pN0 tumors . Patients who did not achieve an undetectable PSA after RP were excluded from treatment according to r and om assignment ( n = 78 ; 20 % ) . Of the remaining 307 patients , 34 patients on the RT arm did not receive RT and five patients on the wait- and -see arm received RT . Therefore , 114 patients underwent RT and 154 patients were treated with a wait- and -see policy . The primary end point was biochemical progression-free survival . RESULTS Biochemical progression-free survival after 5 years in patients with undetectable PSA after RP was significantly improved in the RT group ( 72 % ; 95 % CI , 65 % to 81 % ; v 54 % , 95 % CI , 45 % to 63 % ; hazard ratio = 0.53 ; 95 % CI , 0.37 to 0.79 ; P = .0015 ) . On univariate analysis , Gleason score more than 6 and less than 7 , PSA before RP , tumor stage , and positive surgical margins were predictors of outcome . The rate of grade 3 to 4 late adverse effects was 0.3 % . CONCLUSION Adjuvant RT for pT3 prostate cancer with postoperatively undetectable PSA significantly reduces the risk of biochemical progression . Further follow-up is needed to assess the effect on metastases-free and overall survival",
"BACKGROUND Radiotherapy combined with and rogen-deprivation therapy ( ADT ) is superior to radiotherapy alone in localised prostate cancer ; however , data comparing ADT alone are somewhat limited . OBJECTIVE To compare 3-yr ADT plus radiotherapy with ADT alone in locally advanced prostate cancer patients . DESIGN , SETTING , AND PARTICIPANTS A multicentre r and omised open controlled phase 3 trial in 264 histologically confirmed T3 - 4 or pT3N0M0 prostate cancer patients r and omised from March 2000 to December 2003 . INTERVENTION ADT ( 11.25 mg subcutaneous depot injection of leuprorelin every 3 mo for 3 yr ) plus external-beam radiotherapy or ADT alone . Flutamide ( 750 g/d ) was administered for 1 mo . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary objective was 5 yr progression-free survival ( PFS ) according to clinical or biologic criteria , using the American Society for Therapeutic Radiology and Oncology ( ASTRO ) and the newer ( Phoenix ) definition ( nadir plus 2 ng/ml ) , by intention to treat . Secondary objectives included time to locoregional recurrence and distant metastases , and overall and disease-specific survival . Our Analyses : intent-to-treat analysis , multivariate analyses using a Cox model with a 5 % threshold from univariate analysis , and Kaplan-Meier estimates . RESULTS AND LIMITATIONS ADT alone was administered to 130 patients and combined therapy to 133 . With a median follow-up of 67 mo , 5-yr PFS was 60.9 % for combined therapy versus 8.5 % with ADT alone ( ASTRO ; p Locoregional progression was reported in 9.8 % of combined-therapy patients versus 29.2 % with ADT alone ( p Overall survival was 71.4 % with combined therapy versus 71.5 % with ADT alone ; disease-specific survival was 93.2 % versus 86.2 % . Limitations included the relatively small population and a relatively short follow-up period . CONCLUSIONS Combined therapy strongly favoured improved PFS , locoregional control , and metastasis-free survival . Longer follow-up is needed to assess the potential survival impact",
"PURPOSE Untreated stage pTxN+ prostate cancer is associated with a poor outcome . Monotherapy ( surgery , radiation , hormonal therapy ) alone is associated with a high progression rate . We evaluate whether radical prostatectomy and pelvic lymphadenectomy plus early adjuvant orchiectomy impart a survival advantage compared to pelvic lymphadenectomy and orchiectomy alone in a matched cohort of patients . MATERIAL S AND METHODS Between 1966 and 1995 , 382 and 79 patients with stage pTxN+ prostate cancer underwent pelvic lymphadenectomy and radical prostatectomy plus early adjuvant orchiectomy ( within 3 months of prostatectomy ) , and pelvic lymphadenectomy and orchiectomy only , respectively . We selected 79 matched controls from the prostatectomy plus orchiectomy group for the orchiectomy group . Patients were matched according to the number of positive nodes , clinical grade , clinical stage , age , year of surgery and preoperative prostate specific antigen ( after 1987 ) . The Kaplan-Meier method and stratified Cox proportional hazards model were used to estimate overall and cause specific survival for the 2 groups . RESULTS There was an overall survival advantage at 10 years for the prostatectomy plus orchiectomy ( 66+/-6 % ) compared to the orchiectomy ( 28+/-6 % ) group ( p cause specific survival at 10 years in the prostatectomy plus orchiectomy ( 79+/-5 % ) versus the orchiectomy ( 39+/-7 % ) group ( p apparent survival advantage at 5 years with radical prostatectomy was smaller ( 79+/-8 versus 63+/-9 % orchiectomy ) and not significant ( p = 0.19 ) . CONCLUSIONS This retrospective study of patients with stage pTxN+ PC suggests that radical prostatectomy with early adjuvant orchiectomy may provide a significant advantage in overall and cause specific survival compared to orchiectomy alone",
"PURPOSE Controversy exists as to whether current pretreatment prostate-specific antigen ( PSA ) dynamics enhance outcome prediction in patients undergoing treatment for prostate cancer . We assessed whether pretreatment PSA velocity ( PSAV ) or doubling time ( PSADT ) predicted outcome in men undergoing radical prostatectomy and whether any definition enhanced accuracy of an outcome prediction model . PATIENTS AND METHODS The cohort included 2,938 patients with two or more PSA values before radical prostatectomy . Biochemical recurrence ( BCR ) occurred in 384 patients , and metastases occurred in 63 patients . Median follow-up for patients without BCR was 2.1 years . We used univariate Cox proportional hazards regression to evaluate associations between published definitions of PSADT and PSAV with BCR and metastasis . Predictive accuracy was assessed using the concordance index . RESULTS On univariate analysis , two of 12 PSADT and four of 10 PSAV definitions were univariately associated with both BCR and metastasis ( P predictive accuracy for BCR over PSA alone , and four PSAV definitions improved prediction of metastasis . However , the improvements in predictive accuracy were small , associated with wide CIs , and markedly reduced if additional predictors of stage and grade were included alongside PSA . Modeling with r and om variables suggests that similar results would be expected by chance . CONCLUSION We found no clear evidence that any definition of PSA dynamics substantially enhances the predictive accuracy of a single pretreatment PSA alone",
"Objectives To determine the effect of antibiotic prophylaxis on infective complications after transrectal needle biopsy of the prostate",
"Localized prostate cancer can be treated several different ways , but head‐to‐head comparisons of treatments are infrequent . The authors of this report conducted a r and omized , unblinded , noninferiority trial to compare cryoablation with external beam radiotherapy in these patients",
"BACKGROUND Appropriate timing of and rogen deprivation treatment ( ADT ) for prostate cancer is controversial . Our aim was to determine whether immediate ADT extends survival in men with node-positive prostate cancer who have undergone radical prostatectomy and pelvic lymphadenectomy compared with those who received ADT only once disease progressed . METHODS Eligible patients from 36 institutes in the USA were r and omly assigned in 1988 - 93 to receive immediate ADT ( n=47 ) or to be observed ( n=51 ) , with ADT to be given on detection of distant metastases or symptomatic recurrences . Patients were followed up every 3 months for the first year and every 6 months thereafter . The primary endpoint was progression-free survival ; secondary endpoints were overall and disease-specific survival . Analysis was by intention to treat . To ensure that the treatment groups were comparable , we did a retrospective central pathology review of slides and re grade d the Gleason scores for available sample s. This trial pre date s the requirement for clinical trial registration . FINDINGS At median follow-up of 11.9 years ( range 9.7 - 14.5 for surviving patients ) , men assigned immediate ADT had a significant improvement in overall survival ( hazard ratio 1.84 [ 95 % CI 1.01 - 3.35 ] , p=0.04 ) , prostate-cancer-specific survival ( 4.09 [ 1.76 - 9.49 ] , p=0.0004 ) , and progression-free survival ( 3.42 [ 1.96 - 5.98 ] , p ADT , 30 observation ) , 16 were down grade d from the original Gleason score ( between groups or = 8) and five were up grade d. We recorded similar proportions of score changes in each group ( p=0.68 ) , and no difference in score distribution by treatment ( p=0.38 ) . After adjustment for score , associations were still significant between treatment and survival ( overall , p=0.02 ; disease-specific , p=0.002 ; progression-free survival , p ADT benefits patients with nodal metastases who have undergone prostatectomy and lymphadenectomy , compared with those who receive deferred treatment . The beneficial effects of early ADT , rather than an imbalance in risk factors , are likely to explain the differences in outcomes between treatments",
"PURPOSE Assessment of and rogen deprivation therapy ( ADT ) benefits for prostate cancer treated with dose-escalated radiotherapy ( RT ) . METHODS AND MATERIAL S From 1991 to 2004 , 1,044 patients with intermediate- ( n = 782 ) or high-risk ( n = 262 ) prostate cancer were treated with dose-escalated RT at William Beaumont Hospital . Patients received external-beam RT ( EBRT ) alone , brachytherapy ( high or low dose rate ) , or high dose rate brachytherapy plus pelvic EBRT . Intermediate-risk patients had Gleason score 7 , prostate-specific antigen ( PSA ) 10.0 - 19.9 ng/mL , or Stage T2b-T2c . High-risk patients had Gleason score 8 - 10 , PSA ≥20 , or Stage T3 . Patients were additionally divided specifically by Gleason score , presence of palpable disease , and PSA level to further define subgroups benefitting from ADT . RESULTS Median follow-up was 5 years ; 420 patients received ADT + dose-escalated RT , and 624 received dose-escalated RT alone . For all patients , no advantages in any clinical endpoints at 8 years were associated with ADT administration . No differences in any endpoints were associated with ADT administration based on intermediate- vs. high-risk group or RT modality when analyzed separately . Patients with palpable disease plus Gleason ≥8 demonstrated improved clinical failure rates and a trend toward improved survival with ADT . Intermediate-risk patients treated with brachytherapy alone had improved biochemical control when ADT was given . CONCLUSION Benefits of ADT in the setting of dose-escalated RT remain poorly defined . This question must continue to be addressed in prospect i ve study",
"PURPOSE To determine the impact of adjuvant and rogen deprivation therapy ( ADT ) for patients who have node-positive prostate cancer in the prostate-specific antigen ( PSA ) era . PATIENTS AND METHODS We used linked Surveillance , Epidemiology and End Results -Medicare data to construct a cohort of men who underwent radical prostatectomy ( RP ) between 1991 and 1999 and who had positive regional lymph nodes . We classified men as receiving adjuvant ADT if they received ADT within 120 days of RP , and we compared them to the men who had not received adjuvant ADT . We used propensity scores to balance potential confounders of receiving adjuvant ADT ( ie , tumor characteristics , extent of nodal disease , demographics , receipt of radiation therapy ) and Cox proportional hazard methods to measure the impact of adjuvant ADT on overall survival ( OS ) , stratified by propensity score quintile . We conducted a sensitivity analysis that used 90 , 150 , 180 , and 365 days as the definition for adjuvant ADT . RESULTS A total of 731 men were identified , 209 of whom received ADT within 120 days of RP . There was no statistically significant difference in OS between the adjuvant ADT and non-ADT group ( HR , 0.97 ; 95 % CI , 0.71 to 1.27 ) . There was no statistically significant survival difference with 90 , 150 , 180 , and 365 days as the adjuvant ADT definition . CONCLUSION Deferring immediate ADT in men with positive lymph nodes after RP may not significantly compromise survival . Because observational studies should be considered hypothesis-generating studies , these results should be vali date d in a prospect i ve fashion in a similar patient population",
"From 1978 to 1983 the Radiation Therapy Oncology Group conducted a study to evaluate the role of elective pelvic lymph node irradiation in carcinoma of the prostate . Eligible patients were those with clinical Stage A2 ( occult disease with more than 3 positive chips and poorly differentiated tumor ) and Stage B without clinical ( lymphangiogram ) or biopsy evidence of lymph node involvement . The patients were r and omized to receive 6.5 weeks of either prostatic bed irradiation only 6500 cGy at 180 - 200 cGy per treatment or pelvic node irradiation to 4500 cGy with a boost of 2000 cGy to the prostatic bed bringing the total dose to 6500 cGy . As of February , 1988 , the median follow up has been 7 years and there were 445 analyzable cases who were evaluated for local control , incidence of distant metastases , ned ( no evidence of disease ) survival and survival . The results of the study revealed no statistically significant benefit of elective pelvic irradiation",
"PURPOSE We assessed the outcome of a watchful-waiting protocol with selective delayed intervention by using clinical prostate-specific antigen ( PSA ) , or histologic progression as treatment indications for clinical ly localized prostate cancer . PATIENTS AND METHODS This was a prospect i ve , single-arm , cohort study . Patients were managed with an initial expectant approach . Definitive intervention was offered to those patients with a PSA doubling time of less than 3 years , Gleason score progression ( to 4 + 3 or greater ) , or unequivocal clinical progression . Survival analysis and Cox proportional hazard model were applied to the data . Results A total of 450 patients have been observed with active surveillance . Median follow-up was 6.8 years ( range , 1 to 13 years ) . Overall survival was 78.6 % . The 10-year prostate cancer actuarial survival was 97.2 % . Overall , 30 % of patients have been reclassified as higher risk and have been offered definitive therapy . Of 117 patients treated radically , the PSA failure rate was 50 % , which was 13 % of the total cohort . PSA doubling time of 3 years or less was associated with an 8.5-times higher risk of biochemical failure after definitive treatment compared with a doubling time of more than 3 years ( P hazard ratio for nonprostate cancer to prostate cancer mortality was 18.6 at 10 years . CONCLUSION We observed a low rate of prostate cancer mortality . Among the patients who were reclassified as higher risk and who were treated , PSA failure was relatively common . Other-cause mortality accounted for almost all of the deaths . Additional studies are warranted to improve the identification of patients who harbor more aggressive disease despite favorable clinical parameters at diagnosis",
"PURPOSE This trial was design ed to test the hypothesis that total and rogen suppression and whole pelvic radiotherapy ( WPRT ) followed by a prostate boost improves progression-free survival ( PFS ) by > or = 10 % compared with total and rogen suppression and prostate only RT ( PORT ) . This trial was also design ed to test the hypothesis that neoadjuvant hormonal therapy ( NHT ) followed by concurrent total and rogen suppression and RT improves PFS compared with RT followed by adjuvant hormonal therapy ( AHT ) by > or = 10 % . METHODS AND MATERIAL S Patients eligible for the study included those with clinical ly localized adenocarcinoma of the prostate and an elevated prostate-specific antigen level of 15 % . RESULTS The difference in overall survival for the four arms was statistically significant ( p = 0.027 ) . However , no statistically significant differences were found in PFS or overall survival between NHT vs. AHT and WPRT compared with PORT . A trend towards a difference was found in PFS ( p = 0.065 ) in favor of the WPRT + NHT arm compared with the PORT + NHT and WPRT + AHT arms . CONCLUSIONS Unexpected interactions appear to exist between the timing of hormonal therapy and radiation field size for this patient population . Four Phase III trials have demonstrated better outcomes when NHT was combined with RT compared with RT alone . The Radiation Therapy Oncology Group 9413 trial results have demonstrated that when NHT is used in conjunction with RT , WPRT yields a better PFS than does PORT . It also showed that when NHT + WPRT results in better overall survival than does WPRT + short-term AHT . Additional studies are warranted to determine whether the failure to demonstrate an advantage for NHT + WPRT compared with PORT + AHT is chance or , more likely , reflects a previously unrecognized biologic phenomenon",
"OBJECTIVE Our aim was to present a summary of the 2010 version of the European Association of Urology ( EAU ) guidelines on the screening , diagnosis , and treatment of clinical ly localised cancer of the prostate ( PCa ) . METHODS The working panel performed a literature review of the new data emerging from 2007 to 2010 . The guidelines were up date d , and level of evidence and grade of recommendation were added to the text based on a systematic review of the literature , which included a search of online data bases and bibliographic review s. RESULTS A full version is available at the EAU office or Web site ( www.uroweb.org ) . Current evidence is insufficient to warrant widespread population -based screening by prostate-specific antigen ( PSA ) for PCa . A systematic prostate biopsy under ultrasound guidance and local anaesthesia is the preferred diagnostic method . Active surveillance represents a viable option in men with low-risk PCa and a long life expectancy . PSA doubling time in a biopsy progression indicates the need for active intervention . In men with locally advanced PCa in whom local therapy is not m and atory , watchful waiting ( WW ) is a treatment alternative to and rogen-deprivation therapy ( ADT ) with equivalent oncologic efficacy . Active treatment is mostly recommended for patients with localised disease and a long life expectancy with radical prostatectomy ( RP ) shown to be superior to WW in a prospect i ve r and omised trial . Nerve-sparing RP represents the approach of choice in organ-confined disease ; neoadjuvant and rogen deprivation demonstrates no improvement of outcome variables . Radiation therapy should be performed with at least 74 Gy and 78 Gy in low-risk and intermediate/high-risk PCa , respectively . For locally advanced disease , adjuvant ADT for 3 yr results in superior disease-specific and overall survival rates and represents the treatment of choice . Follow-up after local therapy is largely based on PSA , and a disease-specific history with imaging is indicated only when symptoms occur . CONCLUSIONS The knowledge in the field of PCa is rapidly changing . These EAU guidelines on PCa summarise the most recent findings and put them into clinical practice",
"CONTEXT The initial report of the Selenium and Vitamin E Cancer Prevention Trial ( SELECT ) found no reduction in risk of prostate cancer with either selenium or vitamin E supplements but a statistically nonsignificant increase in prostate cancer risk with vitamin E. Longer follow-up and more prostate cancer events provide further insight into the relationship of vitamin E and prostate cancer . OBJECTIVE To determine the long-term effect of vitamin E and selenium on risk of prostate cancer in relatively healthy men . DESIGN , SETTING , AND PARTICIPANTS A total of 35,533 men from 427 study sites in the United States , Canada , and Puerto Rico were r and omized between August 22 , 2001 , and June 24 , 2004 . Eligibility criteria included a prostate-specific antigen ( PSA ) of 4.0 ng/mL or less , a digital rectal examination not suspicious for prostate cancer , and age 50 years or older for black men and 55 years or older for all others . The primary analysis included 34,887 men who were r and omly assigned to 1 of 4 treatment groups : 8752 to receive selenium ; 8737 , vitamin E ; 8702 , both agents , and 8696 , placebo . Analysis reflect the final data collected by the study sites on their participants through July 5 , 2011 . INTERVENTIONS Oral selenium ( 200 μg/d from L-selenomethionine ) with matched vitamin E placebo , vitamin E ( 400 IU/d of all rac-α-tocopheryl acetate ) with matched selenium placebo , both agents , or both matched placebos for a planned follow-up of a minimum of 7 and maximum of 12 years . MAIN OUTCOME MEASURES Prostate cancer incidence . RESULTS This report includes 54,464 additional person-years of follow-up and 521 additional cases of prostate cancer since the primary report . Compared with the placebo ( referent group ) in which 529 men developed prostate cancer , 620 men in the vitamin E group developed prostate cancer ( hazard ratio [ HR ] , 1.17 ; 99 % CI , 1.004 - 1.36 , P = .008 ) ; as did 575 in the selenium group ( HR , 1.09 ; 99 % CI , 0.93 - 1.27 ; P = .18 ) , and 555 in the selenium plus vitamin E group ( HR , 1.05 ; 99 % CI , 0.89 - 1.22 , P = .46 ) . Compared with placebo , the absolute increase in risk of prostate cancer per 1000 person-years was 1.6 for vitamin E , 0.8 for selenium , and 0.4 for the combination . CONCLUSION Dietary supplementation with vitamin E significantly increased the risk of prostate cancer among healthy men . TRIAL REGISTRATION Clinical trials.gov Identifier : NCT00006392",
"BACKGROUND The combination of radiotherapy plus long-term medical suppression of and rogens ( > or = 2 years ) improves overall survival in patients with locally advanced prostate cancer . We compared the use of radiotherapy plus short-term and rogen suppression with the use of radiotherapy plus long-term and rogen suppression in the treatment of locally advanced prostate cancer . METHODS We r and omly assigned patients with locally advanced prostate cancer who had received external-beam radiotherapy plus 6 months of and rogen suppression to two groups , one to receive no further treatment ( short-term suppression ) and the other to receive 2.5 years of further treatment with a luteinizing hormone-releasing hormone agonist ( long-term suppression ) . An outcome of noninferiority of short-term and rogen suppression as compared with long-term suppression required a hazard ratio of more than 1.35 for overall survival , with a one-sided alpha level of 0.05 . An interim analysis showed futility , and the results are presented with an adjusted one-sided alpha level of 0.0429 . RESULTS A total of 1113 men were registered , of whom 970 were r and omly assigned , 483 to short-term suppression and 487 to long-term suppression . After a median follow-up of 6.4 years , 132 patients in the short-term group and 98 in the long-term group had died ; the number of deaths due to prostate cancer was 47 in the short-term group and 29 in the long-term group . The 5-year overall mortality for short-term and long-term suppression was 19.0 % and 15.2 % , respectively ; the observed hazard ratio was 1.42 ( upper 95.71 % confidence limit , 1.79 ; P=0.65 for noninferiority ) . Adverse events in both groups included fatigue , diminished sexual function , and hot flushes . CONCLUSIONS The combination of radiotherapy plus 6 months of and rogen suppression provides inferior survival as compared with radiotherapy plus 3 years of and rogen suppression in the treatment of locally advanced prostate cancer . ( Clinical Trials.gov number , NCT00003026 .",
"CONTEXT Comorbidities may increase the negative effects of specific anticancer treatments such as and rogen suppression therapy ( AST ) . OBJECTIVES To compare 6 months of AST and radiation therapy ( RT ) to RT alone and to assess the interaction between level of comorbidity and all-cause mortality . DESIGN , SETTING , AND PATIENTS At academic and community-based medical centers in Massachusetts , between December 1 , 1995 , and April 15 , 2001 , 206 men with localized but unfavorable-risk prostate cancer were r and omized to receive RT alone or RT and AST combined . All-cause mortality estimates stratified by r and omized treatment group and further stratified in a postr and omization analysis by the Adult Comorbidity Evaluation 27 comorbidity score were compared using a log-rank test . MAIN OUTCOME MEASURE Time to all-cause mortality . RESULTS As of January 15 , 2007 , with a median follow-up of 7.6 ( range , 0.5 - 11.0 ) years , 74 deaths have occurred . A significant increase in the risk of all-cause mortality ( 44 vs 30 deaths ; hazard ratio [ HR ] , 1.8 ; 95 % confidence interval [ CI ] , 1.1 - 2.9 ; P = .01 ) was observed in men r and omized to RT compared with RT and AST . However , the increased risk in all-cause mortality appeared to apply only to men r and omized to RT with no or minimal comorbidity ( 31 vs 11 deaths ; HR , 4.2 ; 95 % CI , 2.1 - 8.5 ; P men with moderate or severe comorbidity , those r and omized to RT alone vs RT and AST did not have an increased risk of all-cause mortality ( 13 vs 19 deaths ; HR , 0.54 ; 95 % CI , 0.27 - 1.10 ; P = .08 ) . CONCLUSIONS The addition of 6 months of AST to RT result ed in increased overall survival in men with localized but unfavorable-risk prostate cancer . This result may pertain only to men without moderate or severe comorbidity , but this requires further assessment in a clinical trial specifically design ed to assess this interaction . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00116220",
"BACKGROUND Previous prospect i ve r and omised trials have shown a positive impact of adjuvant radiation therapy ( RT ) in patients with locally advanced prostate cancer . However , none of these trials included patients with lymph node invasion ( LNI ) . OBJECTIVE The aim of this study was to assess the impact of combination adjuvant hormonal therapy ( HT ) and RT on the survival of patients with prostate cancer and histologically documented lymph node metastases ( pN+ ) . DESIGN , SETTING , AND PARTICIPANTS Data on 703 consecutive patients with LNI treated with radical prostatectomy , pelvic lymph node dissection , and adjuvant treatments between September 1986 and November 2002 at two large academic institutions were review ed . MEASUREMENTS For study purpose s , patients treated with adjuvant HT plus RT and patients treated with adjuvant HT alone were matched for age at surgery , pathologic T stage and Gleason score , number of nodes removed , surgical margin status , and length of follow-up . Differences in cancer-specific survival ( CSS ) and overall survival ( OS ) were compared using the Kaplan-Meier method and life table analyses . RESULTS AND LIMITATIONS Following the matching process , 117 pT2 - 4 pN1 patients of 171 ( 68.4 % ) treated with adjuvant HT plus RT ( group 1 ) were compared with 247 pT2 - 4 pN1 patients of 532 ( 46.4 % ) receiving adjuvant HT alone ( group 2 ) . After matching , the two groups of patients were comparable in terms of pre- and postoperative characteristics ( all p ≥ 0.07 ) . Mean follow-up was 100.8 mo ( median : 95.1 mo ; range : 3.5 - 229.3 mo ) . Overall , prostate CSS and OS rates at 5 , 8 , and 10 yr were 90 % , 82 % , and 75 % , and 85 % , 70 % , and 60 % , respectively . Patients treated with adjuvant RT plus HT had significantly higher CSS and OS rates compared with patients treated with HT alone at 5 , 8 , and 10 yr after surgery ( 95 % , 91 % , and 86 % vs 88 % , 78 % , and 70 % , and 90 % , 84 % , and 74 % vs 82 % , 65 % , and 55 % , respectively ; p = 0.004 and p higher survival rates associated with the combination of HT plus RT were found when patients were stratified according to the extent of nodal invasion ( namely , two or fewer vs more than two positive nodes ; all p ≤ 0.006 ) . Lack of st and ardised HT and RT protocol s represents the main limitations of our retrospective study . CONCLUSIONS Adjuvant RT plus HT significantly improved CSS and OS of pT2 - 4 pN1 patients , regardless of the extent of nodal invasion . These results reinforce the need for a multimodal approach in the treatment of node-positive prostate cancer"
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The aim of this systematic review was to determine the attitudes and beliefs of doctors to acute low back pain , and the factors that influence these . The review comprised three phases : a method ological assessment of data bases ( Medline , EMBASE , Psychinfo , BIOSIS , CINAHL , and the Cochrane Central Register of Controlled Trials ) identified potential papers ; these were screened for inclusion criteria by two independent review ers , the extraction of data and the rating of internal validity and strength of the evidence , using valid and reliable scales from accepted papers . Themes were then identified from the accepted literature . The search generated a total of 15 papers of both qualitative ( n=3 ) and quantitative ( n=12 ) method ologies . Themes that emerged included doctors ' attitudes and beliefs , and four factors that influenced attitudes and beliefs : doctors ' specialty , demographic factors , personal beliefs and education . There was consistent evidence that doctors ' specialty impacted their attitudes and beliefs : lack of consensus regarding the natural history of LBP , around treatment options , and issues regarding work . There was inconsistent evidence that demographic factors ( age ) and level of education impacted doctors ' attitudes and beliefs . Strategies to address/ modify these attitudes and beliefs are required , as in some cases they are at odds with guideline recommendations . Long term , these changes in these areas have the potential to maximise patient-care , and reduce costs to health services
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"BACKGROUND AND PURPOSE An active strategy was developed for the implementation of the clinical guidelines on physical therapy for patients with low back pain . The effect of this strategy on patients ' physical functioning , coping strategy , and beliefs regarding their low back pain was studied . SUBJECTS One hundred thirteen primary care physical therapists treated a total of 500 patients . METHODS The physical therapists were r and omly assigned to 1 of 2 groups . The control group received the guidelines by mail ( st and ard passive method of dissemination ) . The intervention group , in contrast , received an additional active training strategy consisting of 2 sessions with education , group discussion , role playing , feedback , and reminders . Patients with low back pain , treated by the participating therapists , completed question naires on physical functioning , pain , sick leave , coping , and beliefs . RESULTS Physical functioning and pain in the 2 groups improved substantially in the first 12 weeks . Multilevel longitudinal analysis showed no differences between the 2 groups on any outcome measure during follow-up . DISCUSSION AND CONCLUSION The authors found no additional benefit to applying an active strategy to implement the physical therapy guidelines for patients with low back pain . Active implementation strategies are not recommended if patient outcomes are to be improved",
"Study Design . A baseline study of the general population and the health care providers in 3 Norwegian counties . Objective . To investigate if beliefs about low back pain ( LBP ) are related to personal experiences and profession sought for care . Summary of Background Data . Myths about LBP that are ab and oned by health professionals are still alive in the public . Such myths represent pain avoidance beliefs and passive coping strategies that may hinder normal spontaneous recovery from an episode of LBP . Methods . A sample of 1502 r and omly selected people was interviewed by telephone , and all the 1105 physicians , physiotherapists , and chiropractors in the area were sent a question naire in April 2002 . All respondents gave their responses in terms of degree of agreement to 6 statements reflecting beliefs about LBP . Results . Personal back pain experiences were important for beliefs about LBP . People with a history of previous back pain had more faith in the 2 statements “ Back pain recovers best by itself ” ( 52.2 % ) and “ In most cases back pain recovers by itself in a couple of weeks ” ( 32.5 % ) than those with current pain ( 36.9 % and 20.9 % , respectively , P beliefs between physicians and the chiropractors concerning the same 2 statements , and these differences were also reflected in the beliefs of patients treated by the different professional groups . Conclusions . Belief in spontaneous recovery from LBP seems to be positively correlated to previous experience with LBP without current pain . Patients of the various health care providers seem to have a faith in spontaneous recovery similar to that of their health care provider . These differences may frustrate the public and patients who visit more than one provider , and hinder collaboration among professional groups",
"The primary purpose of this study was to examine the extent to which specific patient attitudes and beliefs about medical care and self-care for back pain predict future healthcare use . An automated data base allowed examination of the predictive relationships in two primary care patient sample s. In general , beliefs that physicians should find a definitive cause and permanent cure for back pain predicted neither physician visits nor prescription medication fills . Patient attitudes endorsing the benefits of medical treatment for back pain ( as opposed to a permanent cure ) predicted the use of these specific healthcare services . In a third sample of primary care back pain patients , we assessed whether a four-session self-care intervention modified those attitudes and beliefs shown to predict future healthcare use . The group intervention was associated with changes in attitudes about use of physician services but not medication use . A secondary purpose was to examine initial psychometric properties of a proposed back pain Self-Care Orientation Scale made up of the original 11 items . Factor analyses of the item set yielded three factors , but inconclusive results ; the internal consistency of the identified sub-scales was only moderate . However , findings that a subset of items predicted physician visits and prescriptions medication fills , and was sensitive to change following a self-care intervention , suggest avenues for improving measurement of self-care orientation . These findings help clarify specific patient attitudes and beliefs that are related to healthcare utilization and suggest that a subset of these beliefs can be modified through a brief educational intervention",
"We r and omly surveyed 100 specialists in rehabilitation medicine and 100 rheumatologists concerning their perceptions of the value of 11 different physical modalities -- cold , active and passive exercise , interferential current , laser , magnetotherapy , microwave , shortwave diathermy , traction , ultrasound and transcutaneous nerve stimulation in the treatment of seven different musculoskeletal conditions -- acute arthritis , joint contracture , neck pain , back pain , tendinitis , reflex sympathetic dystrophy and frozen shoulder . There were significant differences in the perceived benefits of modalities which varied by modality and condition . Overall , rehabilitation medicine specialists regarded modalities to be helpful more often than rheumatologists ( P < 0.001 )",
"& NA ; Psychosocial factors have been shown to play an important role in the development of chronic low back pain ( LBP ) . In our recently completed cluster‐r and omized trial we found , however , no evidence of an effect of our minimal intervention strategy ( MIS ) aim ed at psychosocial factors , over usual care ( UC ) in patients with (sub)acute LBP . To explore the reasons why , this paper presents an evaluation of the processes presumably underlying the effectiveness of MIS . General practitioner ( GP ) attitude was evaluated by the Pain Attitudes and Beliefs Scale and two additional questions . GP behaviour was evaluated by analysing treatment registration forms and patients ' responses to items regarding treatment content . Patients also scored items on satisfaction and compliance . Modification of psychosocial measures was evaluated by analysing changes after 6 and 52 weeks on the Fear Avoidance and Beliefs Question naire , the Coping Strategies Question naire and the 4‐Dimensional Symptom Question naire . A total of 60 GPs and 314 patients participated in the study . GPs in the MIS‐group adopted a less biomedical orientated attitude than in the UC‐group , but were only moderately successful in identification of psychosocial factors . Treatment contents as perceived by the patient and patient satisfaction differed significantly between both groups . Changes on psychosocial measures , however , did not differ between groups . The suboptimal identification of psychosocial factors in the MIS‐group and the absence of a relevant impact on psychosocial factors may explain why MIS was not more effective than UC ",
"There are no national low back pain ( LBP ) clinical guidelines in Irel and , and neither the level of adherence of General Practitioners ( GPs ) to the European guidelines , nor the cost of LBP to the patient and the state , have been investigated . A prospect i ve pilot study was conducted on 54 consenting patients ( 18 M , 36F : mean age ( SD ) : 40.5 ( 14.3 ) years ) with a new episode of acute LBP ( Baseline demographic , LBP classification [ i.e. simple back ache ( SBA ) , nerve root pain ( NRP ) , serious spinal pathology ( SSP ) ] and primary care management data were recorded over a three month period . Adherence and costs were estimated based on : medication prescription , referral for investigations , treatment or consultations , and wage replacement costs ( time signed off work ) . For both SBA and NRP , medication prescriptions were consistent with European guideline recommendations , but not for referral for further treatment ( 39 % of SBA patients were referred on first visit ) , secondary care ( 54 % of NRP patients were referred on first visit ) , or discontinuation of work ( 50 % NRP patients on first GP visit ) . The average total cost ( direct and wage replacement ) for a single episode of LBP over 12 weeks was 20,531 Euros ( 20,300 - 20,762 ) . Direct costs accounted for 43 % [ 8874.36 Euros , ( 8643.37 - 9105.37 Euros ) ] and wage replacement costs 57 % ( 11,657 Euros ) . In conclusion , management of acute LBP in a cohort of GPs in Irel and was not consistent with European clinical guideline recommendations , and warrants higher levels of postgraduate education among GPs , as well as restructuring of primary care services , which should improve patient outcome and reduce costs",
"Concepts of disease , illness ( being ill ) , and criteria for issuing sickness certificate for musculoskeletal pain have been investigated by a postal survey based on case histories . Question naires were filled in by 898 individuals ; 194 General Practitioners , 76 medical consultants working for the National Insurance Administration , 307 insurance clerks , and a representative sample ( N = 321 ) of the general public . The concepts disease and illness are meaningful and used consistently by medical doctors for infectious disease and somatic problems . Discrepancies between the medical profession representatives and the general public were , in general , attributable to differences in information and knowledge about these somatic conditions . However , for musculoskeletal pain all groups had conceptual problems . In particular , there was a lack of consensus for issuing sickness certificates . For musculoskeletal pain conditions the doctors , as a group , seemed to score at r and om or 50 - 50 level for sickness certification . All groups , including medical doctors , were reluctant to accept depression and social problems as diseases , or to accept social problems as reasons for sickness certification . The decision criteria should be identified and systematized in order to establish whether it is possible to reach a consensus for subjective complaints"
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41174434-06ff-11f0-808a-c43d1ab1c353
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Aims The purpose of this research was to investigate the effectiveness of telemonitoring for chronic obstructive pulmonary disease . Methods We search ed MEDLINE , EMBASE , the Cochrane Central Register of Controlled Trials and CINAHL up to September 2018 . We selected r and omised controlled trials comparing telemonitoring and control groups for chronic obstructive pulmonary disease management . Two review ers independently examined articles based on eligibility , extracted data and evaluated the risk of bias . The Cochrane tool was applied for assessing the risk of bias . The 95 % confidence interval was calculated . Results A total of 28 r and omised controlled trials were included . Meta- analysis revealed that there were no variables showing a statistically significant difference between telemonitoring and control groups . Chronic obstructive pulmonary disease exacerbation rate ( six studies ) was not different between two groups ( risk ratio 0.67 , 95 % confidence interval 0.31–1.42 ) . Subgroup analysis showed that telemonitoring reduced exacerbation rates when the intervention continued for longer than six months or pulmonary function was monitored . No differences between groups were noticed for mortality ( seven studies , risk ratio 0.89 , 95 % confidence interval 0.60–1.34 ) . Similarly , no differences between groups were observed in the patient-reported outcomes ( St George ’s Respiratory Question naire , Chronic Respiratory Disease Question naire-Dyspnea score ) and for health service utilization ( length of hospital stay , number of hospital admissions , number of emergency room visits ) . Conclusions Telemonitoring for chronic obstructive pulmonary disease was unlikely to result in statistically significant improvements in health outcomes . However , our novel finding was that at least six months of intervention duration and monitoring of pulmonary function play roles in activating the effects of telemonitoring
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"Chronic obstructive pulmonary disease ( COPD ) is the leading cause of death worldwide , and poses a substantial economic and social burden . Telemonitoring has been proposed as a solution to this growing problem , but its impact on patient outcome is equivocal . This r and omized controlled trial aim ed to investigate effectiveness of telemonitoring in improving COPD patient outcome . In total , 106 subjects were r and omly assigned to the telemonitoring ( n = 53 ) or usual care ( n = 53 ) group . During the two months following discharge , telemonitoring group patients had to report their symptoms daily using an electronic diary . The primary outcome measure was time to first re-admission for COPD exacerbation within six months of discharge . During the follow-up period , time to first re-admission for COPD exacerbation was significantly increased in the telemonitoring group than in the usual care group ( p = 0.026 ) . Telemonitoring was also associated with a reduced number of all-cause re-admissions ( 0.23 vs. 0.68/patient ; p = 0.002 ) and emergency room visits ( 0.36 vs. 0.91/patient ; p = 0.006 ) . In conclusion , telemonitoring intervention was associated with improved outcomes among COPD patients admitted for exacerbation in a country characterized by a small territory and high accessibility to medical services . The findings are encouraging and add further support to implementation of telemonitoring as part of COPD care",
"Objective To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care . Design Research er blind , multicentre , r and omised controlled trial . Setting UK primary care ( Lothian , Scotl and ) . Participants Adults with at least one admission for chronic obstructive pulmonary disease ( COPD ) in the year before r and omisation . We excluded people who had other significant lung disease , who were unable to provide informed consent or complete the study , or who had other significant social or clinical problems . Interventions Participants were recruited between 21 May 2009 and 28 March 2011 , and central ly r and omised to receive telemonitoring or conventional self monitoring . Using a touch screen , telemonitoring participants recorded a daily question naire about symptoms and treatment use , and monitored oxygen saturation using linked instruments . Algorithms , based on the symptom score , generated alerts if readings were omitted or breached thresholds . Both groups received similar care from existing clinical services . Main outcome measures The primary outcome was time to hospital admission due to COPD exacerbation up to one year after r and omisation . Other outcomes included number and duration of admissions , and vali date d question naire assessment s of health related quality of life ( using St George ’s respiratory question naire ( SGRQ ) ) , anxiety or depression ( or both ) , self efficacy , knowledge , and adherence to treatment . Analysis was intention to treat . Results Of 256 patients completing the study , 128 patients were r and omised to telemonitoring and 128 to usual care ; baseline characteristics of each group were similar . The number of days to admission did not differ significantly between groups ( adjusted hazard ratio 0.98 , 95 % confidence interval 0.66 to 1.44 ) . Over one year , the mean number of COPD admissions was similar in both groups ( telemonitoring 1.2 admissions per person ( st and ard deviation 1.9 ) v control 1.1 ( 1.6 ) ; P=0.59 ) . Mean duration of COPD admissions over one year was also similar between groups ( 9.5 days per person ( st and ard deviation 19.1 ) v 8.8 days ( 15.9 ) ; P=0.88 ) . The intervention had no significant effect on SGRQ scores between groups ( 68.2 ( st and ard deviation 16.3 ) v 67.3 ( 17.3 ) ; adjusted mean difference 1.39 ( 95 % confidence interval −1.57 to 4.35 ) ) , or on other question naire outcomes . Conclusions In participants with a history of admission for exacerbations of COPD , telemonitoring was not effective in postponing admissions and did not improve quality of life . The positive effect of telemonitoring seen in previous trials could be due to enhancement of the underpinning clinical service rather than the telemonitoring communication . Trial registration IS RCT N96634935 . Funding : The trial was funded by an NHS applied research programme grant from the Chief Scientist Office of the Scottish government ( ARPG/07/03 ) . The funder had no role in study design and the collection , analysis , and interpretation of data and the writing of the article and the decision to su bmi t it for publication . NHS Lothian supported the telemonitoring service and the clinical services",
"Background We conducted a r and omized controlled trial of a digital health system supporting clinical care through monitoring and self-management support in community-based patients with moderate to very severe chronic obstructive pulmonary disease ( COPD ) . Objective The aim of this study was to determine the efficacy of a fully automated Internet-linked , tablet computer-based system of monitoring and self-management support ( EDGE ‚ sElf-management anD support proGrammE ) in improving quality of life and clinical outcomes . Methods We compared daily use of EDGE with usual care for 12 months . The primary outcome was COPD -specific health status measured with the St George ’s Respiratory Question naire for COPD ( SGRQ-C ) . Results A total of 166 patients were r and omized ( 110 EDGE , 56 usual care ) . All patients were included in an intention to treat analysis . The estimated difference in SGRQ-C at 12 months ( EDGE−usual care ) was −1.7 with a 95 % CI of −6.6 to 3.2 ( P=.49 ) . The relative risk of hospital admission for EDGE was 0.83 ( 0.56 - 1.24 , P=.37 ) compared with usual care . Generic health status ( EQ-5D , EuroQol 5-Dimension Question naire ) between the groups differed significantly with better health status for the EDGE group ( 0.076 , 95 % CI 0.008 - 0.14 , P=.03 ) . The median number of visits to general practitioners for EDGE versus usual care were 4 versus 5.5 ( P=.06 ) and to practice nurses were 1.5 versus 2.5 ( P=.03 ) , respectively . Conclusions The EDGE clinical trial does not provide evidence for an effect on COPD -specific health status in comparison with usual care , despite uptake of the intervention . However , there appears to be an overall benefit in generic health status ; and the effect sizes for improved depression score , reductions in hospital admissions , and general practice visits warrants further evaluation and could make an important contribution to supporting people with COPD . Trial registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 40367841 ; http://www.is rct n.com/IS RCT N40367841 ( Archived by WebCite at http://www.webcitation.org/6pmfIJ9KK",
"Rationale : Early detection of chronic obstructive pulmonary disease ( COPD ) exacerbations using telemonitoring of physiological variables might reduce the frequency of hospitalization . Objectives : To evaluate the efficacy of home monitoring of lung mechanics by the forced oscillation technique and cardiac parameters in older patients with COPD and comorbidities . Methods : This multicenter , r and omized clinical trial recruited 312 patients with Global Initiative for Chronic Obstructive Lung Disease grade s II to IV COPD ( median age , 71 yr [ interquartile range , 66‐76 yr ] ; 49.6 % grade II , 50.4 % grade s III‐IV ) , with a history of exacerbation in the previous year and at least one nonpulmonary comorbidity . Patients were r and omized to usual care ( n = 158 ) or telemonitoring ( n = 154 ) and followed for 9 months . All telemonitoring patients self‐assessed lung mechanics daily , and in a subgroup with congestive heart failure ( n = 37 ) cardiac parameters were also monitored . An algorithm identified deterioration , triggering a telephone contact to determine appropriate interventions . Measurements and Main Results : Primary outcomes were time to first hospitalization ( TTFH ) and change in the EuroQoL EQ‐5D utility index score . Secondary outcomes included : rate of antibiotic/corticosteroid prescription ; hospitalization ; the COPD Assessment Tool , Patient Health Question naire‐9 , and Minnesota Living with Heart Failure question naire scores ; quality ‐adjusted life years ; and healthcare costs . Telemonitoring did not affect TTFH , EQ‐5D utility index score , antibiotic prescriptions , hospitalization rate , or question naire scores . In an exploratory analysis , telemedicine was associated with fewer repeat hospitalizations ( −54 % ; P = 0.017 ) . Conclusions : In older patients with COPD and comorbidities , remote monitoring of lung function by forced oscillation technique and cardiac parameters did not change TTFH and EQ‐5D . Clinical trial registered with www . clinical trials.gov ( NCT 01960907 )",
"The objective of this pilot study was to investigate the use of and satisfaction with a chronic obstructive pulmonary disease ( COPD ) telehealth program applied in both primary and secondary care . The program consisted of four modules : 1 ) activity coach for ambulant activity monitoring and real-time coaching of daily activity behavior , 2 ) web-based exercise program for home exercising , 3 ) self-management of COPD exacerbations via a triage diary on the web portal , including self-treatment of exacerbations , and 4 ) teleconsultation . Twenty-nine COPD patients were r and omly assigned to either the intervention group ( telehealth program for 9 months ) or the control group ( usual care ) . Page hits on the web portal showed the use of the program , and the Client Satisfaction Question naire showed satisfaction with received care . The telehealth program with decision support showed good satisfaction ( mean 26.4 , maximum score 32 ) . The program was accessed on 86 % of the treatment days , especially the diary . Patient adherence with the exercise scheme was low ( 21 % ) . Health care providers seem to play an important role in patients ’ adherence to telehealth in usual care . Future research should focus on full-scale implementation in daily care and investigating technological advances , like gaming , to increase adherence",
"AIMS To investigate the feasibility , acceptance and potential effectiveness of delivering a telecare service on the health outcomes and hospital service utilization of community-dwelling patients with chronic obstructive pulmonary disease . METHODS Eligible participants were older people , with moderate or severe chronic obstructive pulmonary disease , and who had been admitted to hospital at least once for exacerbation during the previous year . The participants were r and omly assigned to the intervention or control group . Participants in the intervention group received a telecare device kit and they were asked to monitor their oxygen saturation , pulse rate and respiration rate using the device and to transmit the data to an online network platform . A medication and purse-lip breathing reminder with a feedback function is also provided in the device kit . A community nurse monitors changes in the physiological parameters and takes immediate action to address the patients ' needs . Participants in the control group received no other extra care . Study outcomes include user satisfaction , health-related quality of life , pulmonary function , hospital re-admission and use of emergency room services . RESULTS Twenty-two participants in the intervention group and 18 in the control group were included in the analysis . The mean age of all 40 participants was 72.93 years . Overall , the participants in the intervention group expressed satisfaction with the telecare service . Some patients reported difficulty in reading the screen of the mobile phone and manipulating the tiny key-in buttons . No significant differences were found between the two time points ( baseline and post-test period ) with regard to health-related quality of life . No significant differences in pulmonary function and in the number of emergency department visits and hospital re-admissions between the study groups were found . CONCLUSION The high level of user satisfaction indicated the feasibility of conducting a large-scale r and omized control trial to evaluate the effects of a telecare service on health outcomes of patients with chronic obstructive pulmonary disease",
"Background Although a number of studies have suggested that the use of Telemonitoring ( TM ) in patients with Chronic Obstructive Pulmonary Disease ( COPD ) can be useful and efficacious , its real utility in detecting Acute Exacerbation ( AE ) signaling the need for prompt treatment is not entirely clear . The current study aim ed to investigate the benefits of a TM system in managing AE in advanced-stage COPD patients to improve their Health-Related Quality of Life ( HRQL ) and to reduce utilization of healthcare services . Methods A 12-month R and omised Controlled Trial ( RCT ) was conducted in the Veneto region ( Italy ) . Adult patients diagnosed with Class III-IV COPD in accordance with the Global Initiative for Chronic Obstructive Lung Disease ( GOLD ) classification were recruited and provided a TM system to alert the clinical staff via a trained operator whenever variations in respiratory parameters fell beyond the individual ’s normal range . The study ’s primary endpoint was HRQL , measured by the Italian version of the two Short Form 36-item Health Survey ( SF36v2 ) . Its secondary endpoints were : scores on the Hospital Anxiety and Depression Scale ( HADS ) ; the number and duration of hospitalizations ; the number of readmissions ; the number of appointments with a pulmonary specialist ; the number of visits to the emergency department ; and the number of deaths . Results Three hundred thirty-four patients were enrolled and r and omized into two groups for a 1 year period . At its conclusion , changes in the SF36 Physical and Mental Component Summary scores did not significantly differ between the TM and control groups [ ( -2.07 ( 8.98 ) vs -1.91 ( 7.75 ) ; p = 0.889 and -1.08 ( 11.30 ) vs -1.92 ( 10.92 ) ; p = 0.5754 , respectively ] . Variations in HADS were not significantly different between the two groups [ 0.85 ( 3.68 ) vs 0.62 ( 3.6 ) ; p = 0.65 and 0.50 ( 4.3 ) vs 0.72 ( 4.5 ) ; p = 0.71 ] . The hospitalization rate for AE COPD and /or for any cause was not significantly different in the two groups [ IRR = 0.89 ( 95 % CI 0.79–1,04 ) ; p = 0.16 and IRR = 0.91 ( 95 % CI 0,75 – 1.04 ) ; p = 0.16 , respectively ] . The readmission rate for AE COPD and /or any cause was , however , significantly lower in the TM group with respect to the control one [ IRR = 0.43 ( 95 % CI 0.19–0.98 ) ; p = 0.01 and 0.46 ( 95 % CI 0.24–0.89 ) ; p = 0.01 , respectively ] . ConclusionS tudy results showed that in areas where medical services are well established , TM does not significantly improve HRQL in patients with COPD who develop AE . Although not effective in reducing hospitalizations , TM can nevertheless facilitate continuity of care during hospital-to-home transition by reducing the need for early readmission . Trial registration Retrospectively registered on January 2012 , Clinical Trials.gov Identifier : NCT01513980",
"Summary We investigated the effect of daily real-time teleconsultations for one week between hospital-based nurses specialised in respiratory diseases and patients with severe COPD discharged after acute exacerbation . Patients admitted with acute exacerbation of chronic obstructive pulmonary disease ( AE COPD ) at two hospitals were recruited at hospital discharge . They were r and omly assigned to intervention or control . The telemedicine equipment consisted of a briefcase with built-in computer including a web camera , microphone and measurement equipment . The primary outcome was the mean number of total hospital readmissions within 26 weeks of discharge . A total of 266 patients ( mean age 72 years ) were allocated to either intervention ( n = 132 ) or control ( n = 134 ) . There was no significant difference in the unconditional total mean number of hospital readmissions after 26 weeks : mean 1.4 ( SD 2.1 ) in the intervention group and 1.6 ( SD 2.4 ) in the control group . In a secondary analysis , there was no significant difference between the two groups in mortality , time to readmission , mean number of total hospital readmissions , mean number of readmissions with AE COPD , mean number of total hospital readmission days or mean number of readmission days with AE COPD calculated at 4 , 8 , 12 and 26 weeks . Thus the addition of one week of teleconsultations between hospital-based nurses and patients with severe COPD discharged after hospitalisation did not significantly reduce readmissions or affect mortality",
"Chronic respiratory patients requiring oxygen or home mechanical ventilation experience frequent exacerbations and hospitalisations with related costs . Strict monitoring and care have been recommended . The aim of the present study was to primarily evaluate reduction in hospitalisations and , secondly , exacerbations , general practitioner ( GP ) calls and related cost-effectiveness of tele-assistance ( TA ) for these patients . A total of 240 patients ( 101 with chronic obstructive pulmonary disease ( COPD ) ) were r and omised to two groups : an intervention group entered a 1-yr TA programme while controls received traditional care . No anthropometric and clinical differences were found between groups both in baseline and in mortality ( 18 % for TA , 23 % for controls ) . Compared with controls , the TA group experienced significantly fewer hospitalisations ( -36 % ) , urgent GP calls ( -65 % ) and acute exacerbations ( -71 % ) . Only COPD patients , as a separate group , had fewer hospitalisations , emergency room admissions , urgent GP calls or exacerbations . Each patient referred to staff a mean±sd 36±25 times . After deduction of TA costs , the average overall cost for each patient was 33 % less than that for usual care . In chronic respiratory failure patients on oxygen or home mechanical ventilation , a nurse-centred tele-assistance prevents hospitalisations while it is cost-effective . The chronic obstructive pulmonary disease group seems to have a greater advantage from tele-assistance ",
"We studied the effect of telemonitoring in addition to usual care compared to usual care alone in patients with chronic obstructive pulmonary disease ( COPD ) . A total of 110 patients with moderate to severe COPD were recruited from a specialist respiratory service in Northern Irel and . Patients had at least two of : emergency department admissions , hospital admissions or emergency general practitioner ( GP ) contacts in the 12 months before the study . Exclusion criteria were patients who had any respiratory disorder other than COPD , or were cognitively unable to learn the process of monitoring . Patients were r and omised to receive six months of home telemonitoring with usual care , or six months of usual care . The primary outcome measure was disease-specific quality of life , as measured by the St George ’s Respiratory Question naire for COPD patients ( SGRQ-C ) . Of 100 patients completing the study , 48 patients were r and omised to telemonitoring and 52 patients were r and omised to the control group . The SGRQ-C scores improved significantly in the intervention group compared to usual care ( P = 0.001 ) . The HADS anxiety score was significantly higher in the telehealth group compared to the usual care group ( P = 0.01 ) . There were significantly more contacts with the Community Respiratory Team in the telemonitoring group compared to the control group ( P = 0.029 ) . There were no significant between group differences in EQ-5D scores , HADS depression scores , GP activity , emergency department visits , hospital admissions or exacerbations . The total cost to the health service of the intervention over the 6-month study period was £ 2039 , giving an estimated ICER of £ 203,900 . In selected patients with COPD , telemonitoring was effective in improving health-related quality of life and anxiety , but was not a cost-effective intervention",
"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",
"We conducted a pilot study of the effectiveness of home telehealth for patients with advanced chronic obstructive pulmonary disease treated with long-term oxygen therapy . Patients were r and omized into a telehealth group ( n = 24 ) and a control group ( n = 21 ) who received usual care . Patients in the telehealth group measured their vital signs on weekdays and performed spirometry on two days per week . The data were transmitted automatically to a clinical call centre . After four months of monitoring the mean number of accident and emergency department visits in the telehealth group was slightly lower than in the control group ( 0.29 versus 0.43 , P = 0.25 ) . The mean number of hospital admissions was 0.38 in the telehealth group and 0.14 in the control group ( P = 0.47 ) . During the study a total of 40 alerts were detected . The clinical triage process detected eight clinical exacerbations which were escalated by the case manager for a specialist consultation . There were clinical ly important differences in health-related quality of life in both groups . The mean score on the SGRQ was 10.9 versus 4.5 in the control group ( P = 0.53 ) . The EuroQol-5D score improved by 0.036 in the telehealth group and by 0.003 in the control group ( P = 0.68 ) . Both patients and healthcare professionals showed a high level of satisfaction with the telehealth programme",
"Objectives To assess the effect of telecare on health related quality of life , self-care , hospital use , costs and the experiences of patients , informal carers and health care professionals . Methods Patients were r and omly assigned either to usual care or to additionally entering their data into a commercially-available electronic device that uploaded data once a day to a nurse-led monitoring station . Patients had congestive heart failure ( Site A ) , chronic obstructive pulmonary disease ( Site B ) , or any long-term condition , mostly diabetes ( Site C ) . Site C contributed only intervention patients – they considered a usual care option to be unethical . The study took place in New Zeal and between September 2010 and February 2012 , and lasted 3 to 6 months for each patient . The primary outcome was health-related quality of life ( SF36 ) . Data on experiences were collected by individual and group interviews and by question naire . Results There were 171 patients ( 98 intervention , 73 control ) . Quality of life , self-efficacy and disease-specific measures did not change significantly , while anxiety and depression both decreased significantly with the intervention . Hospital admissions , days in hospital , emergency department visits , outpatient visits and costs did not differ significantly between the groups . Patients at all sites were universally positive . Many felt safer and more cared-for , and said that they and their family had learned more about managing their condition . Staff could all see potential benefits of telecare , and , after some initial technical problems , many staff felt that telecare enabled them to effectively monitor more patients . Conclusions Strongly positive patient and staff experiences and attitudes complement and contrast with small or non-significant quantitative changes . Telecare led to patients and families taking a more active role in self-management . It is likely that subgroups of patients benefitted in ways that were not measured or visible within the quantitative data , especially feelings of safety and being cared-for . Trial Registration Australian New Zeal and Clinical Trials Registry",
"Background People with chronic obstructive pulmonary disease ( COPD ) continue to experience dyspnea with activities of daily living ( ADL ) despite optimal medical management . Information and communication technologies may facilitate collaborative symptom management and could potentially increase the reach of such interventions to those who are unable to attend face-to-face pulmonary rehabilitation or self-management programs . Objective The purpose of this r and omized study was to test the efficacy of two 6-month dyspnea self-management programs , Internet-based ( eDSMP ) and face-to-face ( fDSMP ) , on dyspnea with ADL in people living with COPD . Methods We r and omly assigned 50 participants with moderate to severe COPD who were current Internet users to either the eDSMP ( n = 26 ) or fDSMP ( n = 24 ) group . The content of the two programs was similar , focusing on education , skills training , and ongoing support for dyspnea self-management , including independent exercise . The only difference was the mode ( Internet/personal digital assistant [ PDA ] or face-to-face ) in which the education sessions , reinforcement contacts , and peer interactions took place . Participants returned to one of two academic clinical sites for evaluation at 3 and 6 months . The primary outcome of dyspnea with ADL was measured with the Chronic Respiratory Question naire . Secondary outcomes of exercise behavior , exercise performance , COPD exacerbations , and mediators , such as self-efficacy and social support , were also measured . A satisfaction survey was administered and a semistructured exit interview was conducted at the final visit . Results The study was stopped early due to multiple technical challenges with the eDSMP , but follow-up was completed on all enrolled participants . Data were available for 39 participants who completed the study ( female : 44 % ; age : 69.5 ± 8.5 years ; percent predicted forced expiratory volume in 1 s : 49.6 ± 17.0 % ) . The fDSMP and eDSMP showed similar clinical ly meaningful changes in dyspnea with ADL from baseline to 3 months ( fDSMP : + 3.3 points ; eDSMP : + 3.5 points ) and sustained these improvements at 6 months ( fDSMP : + 4.0 points ; eDSMP : + 2.5 points ; time effects P P = .51 ) . Self-reported endurance exercise time ( P = .001 ) , physical functioning ( P = .04 ) , and self-efficacy for managing dyspnea ( P = .02 ) also showed positive improvements over time in both groups with no significant differences with respect to program modality . Participants who completed the study reported favorable satisfaction with the programs . Conclusions Although there were numerous technical challenges with the eDSMP , both dyspnea self-management programs were effective in reducing dyspnea with ADL in the short term . Our findings will need to be confirmed in a larger r and omized trial with more mature Web and personal digital assistant tools , use of a control group , and longer follow-up . Trial registration clinical trials.gov NCT00102401 ,",
"Background Chronic obstructive pulmonary disease ( COPD ) is a highly prevalent condition associated with a high health care re source consumption and health care expenditures , driven mainly by exacerbations-related hospitalizations . Telemedicine has been proposed as a mean for timely detection of exacerbation , but the available evidence is inadequate to provide conclusive information on its efficacy . The aim of this study is to evaluate the efficacy of a telemonitoring system in reducing COPD -related hospitalizations in an elderly population with COPD . Methods This is a parallel arms , r and omized trial including patients aged 65 or older with COPD in GOLD stages II and III enrolled in a Pulmonary Medicine outpatient facility . Patients were r and omly assigned to receive a non-invasive system able to telemonitor vital signs ( oxygen saturation , heart rate , near-body temperature , overall physical activity ) or st and ard care , and were followed up for 9 months . The outcome measures were the number of exacerbations and exacerbation-related hospitalization . Results Fifty patients were included in the telemonitoring group and 49 in the control group . The incidence rate of respiratory events was 28/100 person/years in the telemonitoring group vs. 42/100 person/years in the control group ( incidence rate ratio : 0.67 , 95 % CI : 0.32 – 1.36 ) . The corresponding figures for hospital admissions where 13/100 person/years and 20/100 person/years , respectively ( IRR : 0.66 , 95 % CI : 0.21 – 1.86 ) . Conclusions In our study , COPD patients followed up with the aid of a multiparametric remote monitoring system experienced a lower rate of exacerbations and COPD -related hospitalizations compared to patients followed up using the st and ard model of care . These results need to be replicated in larger studies before they can be applied to the general COPD population . Trial registration number : NCT01481506 ( clinical trials.gov ) . Funding : co-financed by Lazio Region and Intersistemi",
"Background The increasing prevalence and associated cost of treating chronic obstructive pulmonary disease ( COPD ) is unsustainable , and focus is needed on self-management and prevention of hospital admissions . Telehealth monitoring of patients ’ vital signs allows clinicians to prioritise their workload and enables patients to take more responsibility for their health . This paper reports the results of a pilot r and omised controlled trial ( RCT ) of Telehealth-supported care within a community-based COPD supported-discharge service . Methods A two-arm pragmatic pilot RCT was conducted comparing the st and ard service with a Telehealth-supported service and assessed the potential for progressing into a full RCT . The co- primary outcome measures were the proportion of COPD patients readmitted to hospital and changes in patients ’ self-reported quality of life . The objectives were to assess the suitability of the methodology , produce a sample size calculation for a full RCT , and to give an indication of cost-effectiveness for both pathways . Results Sixty three participants were recruited ( n = 31 St and ard ; n = 32 Telehealth ) ; 15 participants were excluded from analysis due to inadequate data completion or withdrawal from the Telehealth arm . Recruitment was slow with significant gaps in data collection , due predominantly to an unanticipated 60 % reduction of staff capacity within the clinical team . The sample size calculation was guided by estimates of clinical ly important effects and COPD readmission rates derived from the literature . Descriptive analyses showed that the st and ard service group had a lower proportion of patients with hospital readmissions and a greater increase in self-reported quality of life compared to the Telehealth-supported group . Telehealth was cost-effective only if hospital admissions data were excluded . Conclusions Slow recruitment rates and service reconfigurations prevented progression to a full RCT . Although there are advantages to conducting an RCT with data collection conducted by a frontline clinical team , in this case , challenges arose when re sources within the team were reduced by external events . Gaps in data collection were resolved by recruiting a research nurse . This study reinforces previous findings regarding the difficulty of undertaking evaluation of complex interventions , and provides recommendations for the introduction and evaluation of complex interventions within clinical setting s , such as prioritisation of research within the clinical remit . Trial registration Current Controlled Trials IS RCT N68856013 , registered Nov 2010",
"Self-management strategies improve a variety of health-related outcomes for patients with chronic obstructive pulmonary disease ( COPD ) . These strategies , however , are primarily design ed to improve chronic disease management and have not focused on early detection and early treatment of exacerbations . In COPD , the majority of exacerbations go unreported and treatment is frequently delayed , result ing in worsened outcomes . Therefore , a r and omised clinical trial was design ed to determine whether integration of self-management education with proactive remote disease monitoring would improve health-related outcomes . A total of 40 Global Initiative for Chronic Obstructive Lung Disease stage 3 or 4 COPD patients were r and omised to receive proactive integrated care ( PIC ) or usual care ( UC ) over a 3-month period . The primary and secondary outcomes were change in quality of life , measured by the St George ’s Respiratory Question naire ( SGRQ ) , and change in healthcare costs . PIC dramatically improved SGRQ by 10.3 units , compared to 0.6 units in the UC group . Healthcare costs declined in the PIC group by US$ 1,401 , compared with an increase of US$ 1,709 in the UC group , but this was not statistically significant . PIC uncovered nine exacerbations , seven of which were unreported . Therefore , proactive integrated care has the potential to improve outcomes in chronic obstructive pulmonary disease patients through effects of self-management , as well as early detection and treatment of exacerbations",
"Background A home based tele-monitoring system was developed to assess the effects of heat stress ( days > 25 ° C ) on clinical and functional status in patients with chronic obstructive pulmonary disease ( COPD ) . Methods Sixty-two COPD patients ( GOLD II – IV ) were r and omized into a tele-monitoring Group ( TG , N = 32 ) or Control Group ( CG , N = 30 ) . Tele-monitoring included 1 ) daily clinical status ( COPD Assessment Test-CAT ) , 2 ) daily lung function and 3 ) weekly 6-minute walk test ( 6MWT ) . Duration of monitoring lasted a total of nine months ( 9 M ) . Results From June 1st – August 31st 2012 , 32 days with heat stress ( 29.0 ± 2.5 ° C ) were recorded and matched with 32 thermal comfort days ( 21.0 ± 2.9 ° C ) . During heat stress , the TG showed a significant reduction in lung function and exercise capacity ( FEV1 % predicted : 51.1 ± 7.2 vs. 57.7 ± 5.0 % ; P increase in CAT scores ( 19.2 ± 7.9 vs. 16.2 ± 7.2 ; P suffered exacerbation of COPD compared to CG patients ( 3 vs. 14 ; P = 0.006 ) . Over entire 9 M follow-up , the TG group had fewer exacerbations compared to CG ( 7 vs. 22 ; P = 0.012 ) , shorter cumulative hospital stay ( 34 vs. 97 days ) and 43 % fewer specialist consultations ( 24 . vs. 42 ; P = 0.04 ) . Conclusion Heat stress affects clinical and functional status in COPD . Tele-monitoring reduces exacerbation frequency and health care utilization during heat stress and other periods of the year . Trial registration DRKS-ID : DRK00000705",
"BACKGROUND Remote in-home monitoring ( RM ) of symptoms and physiological variables may allow early detection and treatment of exacerbations of chronic obstructive pulmonary disease ( COPD ) . It is unclear whether RM improves patient outcomes or healthcare re source utilization . This study determined whether RM is feasible in patients with COPD and if RM reduces hospital admissions or length of stay ( LOS ) or improves health-related quality of life ( HRQOL ) . SUBJECTS AND METHODS Forty-four patients were r and omized to st and ard best practice care ( SBP ) ( n=22 ) or SBP+RM ( n=22 ) . RM involved daily recording of physiological variables , symptoms , and medication usage . RESULTS There were no differences ( mean±SD , SBP versus SBP+RM ) in age ( 68±8 versus 70±9 years ) , gender ( male : female 10:12 in both groups ) , or previous computer familiarity ( 59 % versus 50 % ) between groups . The SBP group had a lower forced expiratory volume in 1 s ( 0.66±0.24 versus 0.91±0.34 L , p in number of COPD -related admissions/year ( 1.5±1.8 versus 1.3±1.7 , p=0.76 ) , COPD -related LOS days/year ( 15.6±19.4 versus 11.4±19.6 , p=0.66 ) , total admissions/year ( 2.2±2.1 versus 2.0±2.3 , p=0.86 ) , total LOS days/year ( 22.1±29.9 versus 21.6±30.4 , p=0.88 ) , or HRQOL between the two groups . CONCLUSIONS The addition of RM to SBP was feasible but did not reduce healthcare utilization or improve quality of life in this group of patients already receiving comprehensive respiratory care",
"The purpose of this study was to compare the performance of measures of health-related quality of life in a r and omized controlled trial of respiratory rehabilitation versus conventional community care for patients with chronic airflow limitation . The study included 89 stable patients with moderate to severe chronic airflow limitation with measurement of health status at 12 , 18 , and 24 weeks . Outcomes included two disease-specific ( the Oxygen Cost Diagram and the Chronic Respiratory Question naire [ CRQ ] ) measures , a generic health profile ( the Sickness Impact Profile [ SIP ] ) , and two utility measures ( the St and ard Gamble and the Quality of Well-Being index [ QWB ] ) . Of the measures , only the four domains of the CRQ ( dyspnea , fatigue , mastery , and emotional function ) showed statistically significant differences ( P CRQ and change in other relevant measures , including the 6-minute walk test and global ratings of change in dyspnea , fatigue , and emotional function were generally weak to moderate ( from 0.19 to 0.51 ) . All correlations between change in the QWB , SIP , and St and ard Gamble and other measures were very weak or weak ( up to 0.30 ) . Correlation between change in the three generic measures were all very weak ( health-related quality of life in controlled trials in chronic diseases , they risk misleading conclusions about the effect of treatments on health status",
"We conducted a six-month r and omised controlled trial of home telemonitoring for patients with chronic obstructive pulmonary disease ( COPD ) . A total of 40 stable patients with moderate to severe COPD who had completed pulmonary rehabilitation took part . They were r and omised to receive st and ard care ( controls ) or st and ard care plus home telemonitoring ( intervention ) . During the monitoring period , patients in the telemonitoring group recorded their symptoms and physical observations twice daily . The data were transmitted automatically at night via the home telephone line . Nurses could access the data through a website and receive alerting email messages if certain conditions were detected . The patients completed the St George 's Respiratory Question naire , Hospital Anxiety and Depression and the EuroQoL EQ-5D quality of life scores before and after pulmonary rehabilitation , and then periodically during the trial . There were significant and clinical ly important improvements in the scores immediately following pulmonary rehabilitation , but thereafter there were no differences in quality of life scores between the groups at any time , or consistently within either group over time . The study showed that telemonitoring was safe but , despite being well used , it was not associated with changes in quality of life in patients who had stable COPD",
"We studied whether preventive home monitoring of patients with chronic obstructive pulmonary disease ( COPD ) could reduce the frequency of hospital admissions and lower the cost of hospitalization . Patients were recruited from a health centre , general practitioner ( GP ) or the pulmonary hospital ward . They were r and omized to usual care or tele-rehabilitation with a telehealth monitoring device installed in their home for four months . A total of 111 patients were suitable for inclusion and consented to be r and omized : 60 patients were allocated to intervention and three were lost to follow-up . In the control group 51 patients were allocated to usual care and three patients were lost to follow-up . In the tele-rehabilitation group , the mean hospital admission rate was 0.49 per patient per 10 months compared to the control group rate of 1.17 ; this difference was significant ( P = 0.041 ) . The mean cost of admissions was € 3461 per patient in the intervention group and € 4576 in the control group ; this difference was not significant . The Kaplan-Meier estimates for time to hospital admission were longer for the intervention group than the controls , but the difference was not significant . Future work requires large-scale studies of prolonged home monitoring with more extended follow-up",
"We conducted a systematic review of the evidence on the costs and cost-effectiveness of telehealth for patients with chronic obstructive pulmonary disease ( COPD ) . A literature search identified six relevant economic evaluations that were assessed according to the Consensus Health Economic Criteria list ( CHEC list ) . Three studies were from North America and three studies were from Europe . All studies reported the use of home monitoring devices that measured and transmitted different physical indicators to nurses who provided personalised feedback to patients during weekdays . The six studies involved a total of 559 COPD patients of whom 281 were r and omised to telehealth . The review demonstrated a potential for cost savings . All six studies reported a lower average cost per patient with telehealth plus usual care compared with usual care alone . However , the quality of the economic evidence was poor . Five studies were evaluated as low quality and one study was evaluated as moderate quality , with CHEC list scores of 21–68 % . Caution is advised for healthcare decision-makers seeking large-scale implementation of telehealth in routine clinical practice . The clinical effectiveness of such implementations with follow-up exceeding 12 months has not yet been demonstrated",
"BACKGROUND AND OBJECTIVE Telemedicine , care provided by electronic communication , may serve as an alternative or extension to traditional outpatient visits . This pilot study determined the effects of telemedicine on health-care utilization and health status of chronic obstructive pulmonary disease ( COPD ) patients . METHODS One hundred and one patients were r and omized , 52 patients received telemedicine care and 49 had traditional outpatient visits . The primary outcome was COPD -specific health status , measured with the Clinical COPD Question naire ( CCQ ) . Secondary outcomes included St. George 's Respiratory Question naire ( SGRQ ) and the Short Form-36 ( SF-36 ) and re source use in primary and secondary care . RESULTS The mean age of the participants was 68 ± 9 years and the mean per cent of predicted forced expiratory volume in 1 s was 40.4 ± 12.5 . The CCQ total score deteriorated by 0.14 ± 0.13 in the telemedicine group , and improved by -0.03 ± 0.14 in the control group ( difference 0.17 ± 0.19 , 95 % confidence interval ( CI ) : -0.21 - 0.55 , P = 0.38 ) . The CCQ symptom domain showed a significant and clinical ly relevant difference in favour of the control group , 0.52 ± 0.24 ( 95 % CI : 0.04 - 0.10 , P = 0.03 ) . Similar results were found for the SGRQ , whereas results for SF-36 were inconsistent . Patients in the control group had significantly fewer visits to the pulmonologist in comparison to patients in the telemedicine group ( P = 0.05 ) . The same trend , although not significant , was found for exacerbations after 6 months . CONCLUSIONS This telemedicine model of initiated phone calls by a health-care provider had a negative effect on health status and re source use in primary and secondary care , in comparison with usual care and therefore can not be recommended in COPD patients in its current form",
"ABSTRACT Aim . To see if home telemonitors reduce healthcare use in those with optimized chronic obstructive pulmonary disease ( COPD ) . Methods . We r and omized 40 stable patients with moderate to severe COPD , who had completed at least 12 sessions of outpatient pulmonary rehabilitation ( PR ) , to receive st and ard care ( Controls ) for 52 weeks or st and ard care plus Docobo HealthHUB monitors at home for 26 weeks followed by 26 weeks st and ard care ( Tm Group ) . During the monitoring period , the Tm Group completed symptoms and physical observations twice daily which were stored and then uploaded at 2 am through a freephone l and line . Nurses could access the data through a secure web site and received alerting e-mails if certain combinations of data occurred . Results . There were fewer primary care contacts for chest problems ( p emergency room visits , hospital admissions , days in hospital or contacts to the specialist COPD community nurse team , during the monitoring period . After the monitors were removed , there were no differences between the groups for any of the health care contacts ( p > 0.20 throughout ) . Conclusion . In stable , optimized COPD patients who have already completed PR , telemonitoring in addition to best care , reduces primary care chest contacts but not hospital or specialist team utilization",
"OBJECTIVE To determine if self-monitoring via home-based telehealth equipment could , when combined with ongoing remote monitoring by a nurse , reduce the incidence of hospitalizations and emergency department ( ED ) presentations for people with chronic obstructive pulmonary disease ( COPD ) . SUBJECTS AND METHODS A r and omized controlled trial was used to compare the outcomes for participants receiving the telehealth equipment and monitoring with those for participants in an information-only control group , over a period of 6 months . Participants receiving the telehealth intervention were taught to measure and record their vital signs ( blood pressure , weight , temperature , pulse , and oxygen saturation levels ) on a daily basis . These were then transmitted automatically via telephone to a secure Web site where they were monitored each day by the telehealth nurse . RESULTS The telehealth group had fewer ED presentations and hospital admissions and a reduced length of stay in comparison with the control group . These results were not statistically significant . However , the reduction in health service use was large enough to result in significant cost savings , with the annual cost savings of the telehealth group compared with the control group being $ 2,931 per person . CONCLUSIONS Telehealth monitoring of patient vital signs reduced health service utilization for individuals with COPD and result ed in significant cost savings . In terms of individual health benefits , improvements in participants ' self-management behaviors and control over their condition was evident",
"Objective : First , to investigate the effects of a telerehabilitation intervention on health status and activity level of patients with Chronic Obstructive Pulmonary Disease ( COPD ) , compared to usual care . Second , to investigate how patients comply with the intervention and whether compliance is related to treatment outcomes . Design : a r and omized controlled pilot trial Subjects : Thirty-four patients diagnosed with COPD . Intervention : The telerehabilitation application consists of an activity coach ( 3D-accelerometer with smartphone ) for ambulant activity registration and real-time feedback , complemented by a web portal with a symptom diary for self-treatment of exacerbations . The intervention group used the application for 4 weeks . The control group received usual care . Main measures : Activity level measured by a pedometer ( in steps/day ) , health status by the Clinical COPD Question naire at baseline and after intervention . Compliance was expressed as the time the activity coach was worn . Results : Fourteen intervention and 16 control patients completed the study . Activity level ( steps/day ) was not significantly affected by the intervention over time . There was a non-significant difference in improvement in health status between the intervention ( −0.34±0.55 ) and control group ( 0.02±0.57 , p=0.10 ) . Health status significantly improved within the intervention group ( p=0.05 ) . The activity coach was used more than prescribed ( 108 % ) and compliance was related to the increase in activity level for the first two feedback weeks ( r=0.62 , p=0.03 ) . Conclusions : This pilot study shows the potential of the telerehabilitation intervention : compliance with the activity coach was high , which directly related to an improvement in activity levels "
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Background Physical activity ( PA ) plays an important role in the prevention and management of a number of chronic conditions . Aim : to investigate the evidence for effectiveness of pedometer-driven walking programs to promote physical activity among patients with musculoskeletal disorders ( MSDs ) . Method A comprehensive systematic review was performed using 11 electronic data bases up to 20 February 2014 . Keywords and MeSH terms included “ musculoskeletal disorders ” , “ walking ” , and “ pedometer ” . R and omized controlled trials , published in English , that examined the effects of a pedometer-based walking intervention to increase physical activity levels and improve physical function and pain in patients with musculoskeletal disorders were included . Result Of the 1996 articles retrieved , seven studies ranging in date of publication from 1998 to 2013 met the inclusion criteria , allowing data extraction on 484 participants with an age range of 40 to 82 years . Interventions lasted from 4 weeks to 12 months and the results across studies showed significant increases in step count ( p mean increase in PA of 1950 steps per day relative to baseline . Four studies reported improved scores for pain and /or physical function at the intervention completion point relative to controls . Conclusion This study provides strong evidence for the effectiveness of pedometer walking interventions in increasing PA levels for patients with MSDs . Our findings suggest that a combination of interventions is likely to be the most effective strategy to maximize health benefits in the short term . Further research should include larger sample sizes , and longer intervention duration s are required to support the role of pedometer walking interventions as a long term intervention for management of musculoskeletal disorders
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"Background Most public health guidelines recommend that adults participate in 30 minutes of moderate intensity physical activity on most days of the week . Establishing new ways to achieve these targets in sedentary population s need to be explored . This research evaluated whether the daily use of pedometers could increase physical activity and improve health outcomes in sedentary overweight and obese women . Methods Twenty six overweight and obese middle-aged women were r and omized into two groups : The control group was not able to record their steps daily , whilst the pedometer group , were asked to record the number of steps on a daily basis for 12 weeks . Results Our data showed that the pedometer group significantly increased their steps/day , by 36 % , at the end of the 12 weeks , whereas the control group 's physical activity levels remained unchanged . There was no significant difference in weight or body fat composition in the pedometer group compared to the control group . However , there was a significant decrease in systolic blood pressure in the pedometer group ( 112.8 ± 2.44 mm Hg ) compared to the control group ( 117.3 ± 2.03 mm Hg ) ( p = 0.003 ) . Conclusion In conclusion , this pilot study shows that the combination of having step goals and immediate feedback from using a pedometer was effective in increasing physical activity levels in sedentary overweight and obese women . Trial registration",
"Background Despite considerable knowledge about musculoskeletal disorders ( MSD ) and physical , psychosocial and individual risk factors there is limited knowledge about physical activity as a factor in preventing MSD . In addition , studies of physical activity are often limited to either leisure activity or physical activity at work . Studies among military personnel on the association between physical activity at work and at leisure and MSD are lacking . This study was conducted to find the prevalence of MSD among personnel in the Royal Norwegian Navy and to assess the association between physical activity at work and at leisure and MSD . Methods A question naire about musculoskeletal disorders , physical activity and background data ( employment status , age , gender , body mass index , smoking , education and physical stressors ) was completed by 2265 workers ( 58 % ) 18 to 70 years old in the Royal Norwegian Navy . Multiple logistic regression with 95 % confidence intervals was used to assess the relationship between physical activity and musculoskeletal disorders . Results A total of 32 % of the workers reported musculoskeletal disorders often or very often in one or more parts of the body in the past year . The most common musculoskeletal disorders were in the lower back ( 15 % often or very often ) , shoulders ( 12 % often or very often ) and neck ( 11 % often or very often ) . After adjustment for confounders , physical activity was inversely associated with musculoskeletal disorders for all body sites except elbows , knees and feet . Conclusion The one-year prevalence of musculoskeletal disorders among workers in the Royal Norwegian Navy was rather low . A physically active lifestyle both at work and at leisure was associated with fewer musculoskeletal disorders among personnel in the Royal Norwegian Navy . Prospect i ve studies are necessary to confirm the cause and effect in this association",
"OBJECTIVE To determine whether high exercise adherence improved physical function among older adults with knee osteoarthritis ( OA ) who were overweight or obese . METHODS Associations between exercise adherence , changes in 6-minute walking distance in meters , and self-reported disability ( Western Ontario and McMaster Universities Osteoarthritis Index function subscale ) after 6 and 18 months were examined among an Arthritis , Diet , and Activity Promotion Trial sub sample ( n = 134 ) using multiple linear regression models . RESULTS Higher exercise adherence was associated with greater improvements in 6-minute walking distance after 6 and 18 months and in disability after 6 months . Pain and body mass index ( BMI ) contributed , to some extent , to explaining the link between exercise adherence and changes in physical performance and self-reported disability . CONCLUSION Higher exercise adherence is associated with improved physical function in overweight and obese older adults with knee OA . This indicates that promoting adherence is clinical ly relevant when prescribing exercise regimens that also focus on decreasing pain and BMI",
"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",
"Purpose The purpose of this study was to evaluate the effectiveness of a self-help physical activity program for persons with type 2 diabetes . Effectiveness was measured by cardiovascular indicators , hemoglobin A1C , anthropometric indicators , and activity levels . Methods This intervention study included 53 individuals with type 2 diabetes . Participants were r and omly assigned . Participants in the intervention group attended the usual Diabetes Self-Management Education Program ( DSMEP ) and received a copy of the book , Manpo-kei ; a concise h and out summarizing the key points of Manpo-kei ; and a pedometer . Participants not assigned to the intervention attended the usual DSMEP only . Data collection was completed at the beginning of the study and 3 months later using a lifestyle and diabetes question naire , a physical activity question naire , and cardiovascular and anthropometric measures . Results Those who participated in the intervention demonstrated a significant decrease in hemoglobin A1C , weight , and body fat . In addition , they increased their number of daily steps as measured by the pedometer . The control group also demonstrated a significant decrease in hemoglobin A1C and weight . Both groups demonstrated increases in their regular weekly activity . At the end of the study period , the intervention group had a significantly lower diastolic blood pressure than the control group . Conclusions Pedometers can be a helpful strategy to motivate persons with diabetes to increase physical activity . However , it appears that attendance at DSMEP alone may be enough to increase physical activity for persons with type 2 diabetes",
"Introduction Management of osteoarthritis ( OA ) includes the use of non-pharmacological and pharmacological therapies . Although walking is commonly recommended for reducing pain and increasing physical function in people with OA , glucosamine sulphate has also been used to alleviate pain and slow the progression of OA . This study evaluated the effects of a progressive walking program and glucosamine sulphate intake on OA symptoms and physical activity participation in people with mild to moderate hip or knee OA . Methods Thirty-six low active participants ( aged 42 to 73 years ) were provided with 1500 mg glucosamine sulphate per day for 6 weeks , after which they began a 12-week progressive walking program , while continuing to take glucosamine . They were r and omized to walk 3 or 5 days per week and given a pedometer to monitor step counts . For both groups , step level of walking was gradually increased to 3000 steps/day during the first 6 weeks of walking , and to 6000 steps/day for the next 6 weeks . Primary outcomes included physical activity levels , physical function ( self-paced step test ) , and the WOMAC Osteoarthritis Index for pain , stiffness and physical function . Assessment s were conducted at baseline and at 6- , 12- , 18- , and 24-week follow-ups . The Mann Whitney Test was used to examine differences in outcome measures between groups at each assessment , and the Wilcoxon Signed Ranks Test was used to examine differences in outcome measures between assessment s. Results During the first 6 weeks of the study ( glucosamine supplementation only ) , physical activity levels , physical function , and total WOMAC scores improved ( P people with hip or knee OA , walking a minimum of 3000 steps ( ~30 minutes ) , at least 3 days/week , in combination with glucosamine sulphate , may reduce OA symptoms . A more robust study with a larger sample is needed to support these preliminary findings .Trial Registration Australian Clinical Trials Registry ACTRN012607000159459",
"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",
"Background People over the age of 70 carry the greatest burden of chronic disease , disability and health care use . Participation in physical activity is crucial for health , and walking accounts for much of the physical activity undertaken by sedentary individuals . Pedometers are a useful motivational tool to encourage increased walking and they are cheap and easy to use . The aim of this pilot study was to evaluate the feasibility of the use of pedometers plus a theory-based intervention to assist sedentary older women to accumulate increasing amounts of physical activity , mainly through walking . Methods Female participants over the age of 70 were recruited from primary care and r and omised to receive either pedometer plus a theory-based intervention or a theory-based intervention alone . The theory-based intervention consisted of motivational techniques , goal - setting , barrier identification and self-monitoring with pedometers and daily diaries . The pedometer group were further r and omised to one of three target groups : a 10 % , 15 % or 20 % monthly increase in step count to assess the achievability and acceptability of a range of targets . The primary outcome was change in daily activity levels measured by accelerometry . Secondary outcome measures were lower limb function , health related quality of life , anxiety and depression . Results 54 participants were recruited into the study , with an average age of 76 . There were 9 drop outs , 45 completing the study . All participants in the pedometer group found the pedometers easy to use and there was good compliance with diary keeping ( 96 % in the pedometer group and 83 % in the theory-based intervention alone group ) . There was a strong correlation ( 0.78 ) between accelerometry and pedometer step counts i.e. indicating that walking was the main physical activity amongst participants . There was a greater increase in activity ( accelerometry ) amongst those in the 20 % target pedometer group compared to the other groups , although not reaching statistical significance ( p = 0.192 ) . Conclusion We have demonstrated that it is feasible to use pedometers and provide theory-based advice to community dwelling sedentary older women to increase physical activity levels and a larger study is planned to investigate this further",
"PURPOSE The purpose of this study was to compare the step values of multiple br and s of pedometers over a 24-h period . The following 13 electronic pedometers were assessed in the study : Accusplit Alliance 1510 ( AC ) , Freestyle Pacer Pro ( FR ) , Colorado on the Move ( CO ) , Kenz Lifecorder ( KZ ) , New-Lifestyles NL-2000 ( NL ) , Omron HJ-105 ( OM ) , Oregon Scientific PE316CA ( OR ) , Sportline 330 ( SL330 ) and 345 ( SL345 ) , Walk4Life LS 2525 ( WL ) , Yamax Skeletone EM-180 ( SK ) , Yamax Digi-Walker SW-200 ( YX200 ) , and the Yamax Digi-Walker SW-701 ( YX701 ) . METHODS Ten males ( 39.5 + /- 16.6 yr , mean + /- SD ) and 10 females ( 43.3 + /- 16.6 yr ) ranging in BMI from 19.8 to 35.4 kg.m-2 wore two pedometers for a 24-h period . The criterion pedometer ( YX200 ) was worn on the left side of the body , and a comparison pedometer was worn on the right . Steps counted by each device were recorded at the end of the day for each of the thirteen pedometers . RESULTS Subjects took an average of 9244 steps.d-1 . The KZ , YX200 , NL , YX701 , and SL330 yielded mean values that were not significantly different from the criterion . The FR , AC , SK , CO , and SL345 significantly underestimated steps ( P overestimated steps ( P underestimated by 25 % whereas others overestimated by 45 % . CONCLUSION The KZ , YX200 , NL , and YX701 appear to be suitable for most research purpose s. Given the potential for pedometers in physical activity research , it is necessary that there be consistency across studies in the measurement of \" steps per day .",
"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 )",
"Background Current evidence supports the use of exercise-based treatment for chronic low back pain that encourages the patient to assume an active role in their recovery . Walking has been shown it to be an acceptable type of exercise with a low risk of injury . However , it is not known whether structured physical activity programmes are any more effective than giving advice to remain active . Methods / Design The proposed study will test the feasibility of using a pedometer-driven walking programme , as an adjunct to a st and ard education and advice session in participants with chronic low back pain . Fifty adult participants will be recruited via a number of different sources . Baseline outcome measures including self reported function ; objective physical activity levels ; fear-avoidance beliefs and health-related quality of life will be recorded . Eligible participants will be r and omly allocated under strict , double blind conditions to one of two treatments groups . Participants in group A will receive a single education and advice session with a physiotherapist based on the content of the ' Back Book ' . Participants in group B will receive the same education and advice session . In addition , they will also receive a grade d pedometer-driven walking programme prescribed by the physiotherapist . Follow up outcomes will be recorded by the same research er , who will remain blinded to group allocation , at eight weeks and six months post r and omisation . A qualitative exploration of participants ' perception of walking will also be examined by use of focus groups at the end of the intervention . As a feasibility study , treatment effects will be represented by point estimates and confidence intervals . The assessment of participant satisfaction will be tabulated , as will adherence levels and any recorded difficulties or adverse events experienced by the participants or therapists . This information will be used to modify the planned interventions to be used in a larger r and omised controlled trial . Discussion This paper describes the rationale and design of a study which will test the feasibility of using a structured , pedometer-driven walking programme in participants with chronic low back pain . Trial Registration [ IS RCT N67030896",
"Background Chronic back pain is a significant problem worldwide and may be especially prevalent among patients receiving care in the U.S. Department of Veterans Affairs healthcare system . Back pain affects adults at all ages and is associated with disability , lost workplace productivity , functional limitations and social isolation . Exercise is one of the most effective strategies for managing chronic back pain . Yet , there are few clinical programs that use low cost approaches to help patients with chronic back pain initiate and maintain an exercise program . Methods / Design We describe the design and rationale of a r and omized controlled trial to assess the efficacy of a pedometer-based Internet mediated intervention for patients with chronic back pain . The intervention uses an enhanced pedometer , website and e-community to assist these patients with initiating and maintaining a regular walking program with the primary aim of reducing pain-related disability and functional interference . The study specific aims are : 1 ) To determine whether a pedometer-based Internet-mediated intervention reduces pain-related functional interference among patients with chronic back pain in the short term and over a 12-month timeframe . 2 ) To assess the effect of the intervention on walking ( measured by step counts ) , quality of life , pain intensity , pain related fear and self-efficacy for exercise . 3 ) To identify factors associated with a sustained increase in walking over a 12-month timeframe among patients r and omized to the intervention . Discussion Exercise is an integral part of managing chronic back pain but to be effective requires that patients actively participate in the management process . This intervention is design ed to increase activity levels , improve functional status and make exercise programs more accessible for a broad range of patients with chronic back pain . Trial Registration",
"Background This r and omised , single-blind controlled pilot trial aim ed to determine the effectiveness of a physiotherapy program , including exercise and manual therapy , in reducing impairments and improving physical function and health-related quality of life in people with a history of painful osteoporotic vertebral fracture . Methods 20 participants were r and omly allocated to an intervention ( n = 11 ) or control ( n = 9 ) group . The intervention group attended individual sessions with an experienced clinician once a week for 10 weeks and performed daily home exercises with adherence monitored by a self-report diary . The control group received no treatment . Blinded assessment was conducted at baseline and 11 weeks . Question naires assessed self-reported changes in back pain , physical function , and health-related quality of life . Objective measures of thoracic kyphosis , back and shoulder muscle endurance ( Timed Loaded St and ing Test ) , and function ( Timed Up and Go test ) were also taken . Results Compared with the control group , the intervention group showed significant reductions in pain during movement ( mean difference ( 95 % CI ) -1.8 ( -3.5 to -0.1 ) ) and at rest ( -2.0 ( -3.8 to -0.2 ) ) and significantly greater improvements in Qualeffo physical function ( -4.8 ( -9.2 to -0.5 ) ) and the Timed Loaded St and ing test ( 46.7 ( 16.1 to 77.3 ) secs ) . For the perceived change in back pain over the 10 weeks , 9/11 ( 82 % ) participants in the intervention group rated their pain as ' much better ' compared with only 1/9 ( 11 % ) participants in the control group . Conclusion Despite the modest sample size , these results support the benefits of exercise and manual therapy in the clinical management of patients with osteoporotic vertebral fractures , but need to be confirmed in a larger sample .Trail registration",
"Background Flexed posture commonly increases with age and is related to musculoskeletal impairment and reduced physical performance . The purpose of this clinical study was to systematic ally compare the effects of a physical activity program that specifically address the flexed posture that marks a certain percentage of elderly individuals with a non specific exercise program for 3 months . Methods Participants were r and omly divided into two groups : one followed an Adapted Physical Activity program for flexed posture and the other one completed a non-specific physical activity protocol for the elderly . A multidimensional clinical assessment was performed at baseline and at 3 months including anthropometric data , clinical profile , measures of musculoskeletal impairment and disability . The instrumental assessment of posture was realized using a stereophotogrammetric system and a specific biomechanical model design ed to describe the reciprocal position of the body segments on the sagittal plane in a upright posture . Results The Adapted Physical Activity program determined a significant improvement in several key parameters of the multidimensional assessment in comparison to the non-specific protocol : decreased occiput-to-wall distance , greater lower limb range of motion , better flexibility of pectoralis , hamstrings and hip flexor muscles , increased spine extensor muscles strength . Stereophotogrammetric analysis confirmed a reduced protrusion of the head and revealed a reduction in compensative postural adaptations to flexed posture characterized by knee flexion and ankle dorsiflexion in the participants of the specific program . Conclusion The Adapted Physical Activity program for flexed posture significantly improved postural alignment and musculoskeletal impairment of the elderly . The stereophotogrammetric evaluation of posture was useful to measure the global postural alignment and especially to analyse the possible compensatory strategies at lower limbs in flexed posture",
"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 1 . To demonstrate that combining pedometer use with cognitive and behavioral support material s has a positive effect on physical activity ( PA ) and attitudes towards pedometer use . 2 . To investigate how familiar the study sample is with pedometers and the ' 10,000 steps/day ' recommendation . METHODS From a r and om sample , drawn from the phone book , 304 volunteered ( 18 - 75 year ) to complete a question naire about familiarity with pedometers and the ' 10,000 steps/day ' recommendation . A sample of 103 participants agreed to wear a pedometer for 3 weeks , and was r and omly assigned to a condition with cognitive and behavioral support material s ( n=51 ) or without these material s ( n=52 ) . Participants completed the International Physical Activity Question naire before and after 21 days of pedometer use and an additional question naire on the attitudes towards pedometer use . RESULTS More than 58 % had never heard of a pedometer . In both conditions , walking ( F=10 , p=0.002 ) , moderate PA ( F=11 , p=0.001 ) , and vigorous PA ( F=14 , p interaction effects could be found . Significantly more participants in the condition with support material s had a positive attitude towards pedometer use . CONCLUSION Wearing a pedometer , with or without support material s , may increase PA . In our study , cognitive and behavioral support material s only affected attitudes towards pedometer use . PRACTICE IMPLICATION S More research is needed to investigate the effect of combining pedometer use with support material s on a longer time base and in less motivated people",
"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",
"The authors prospect ively studied the effect of leisure-time physical activity level on hip fracture risk along with the influence of within-subject changes in activity levels , while taking possible confounding by other health behaviors and poor health into account . Analyses were based on pooled data from three population studies conducted in Copenhagen , Denmark . Among 13,183 women and 17,045 men , 1,121 first hip fractures were identified during follow-up . In comparison with being sedentary , the relative risk ( RR ) of hip fracture associated with being moderately physically active 2 - 4 hours per week was 0.72 ( 95 % confidence interval ( CI ) : 0.59 , 0.89 ) in women and 0.75 ( 95 % CI : 0.55 , 1.03 ) in men after adjustment for confounders . Being in the most active leisure activity category did not decrease the risk of hip fracture further . Adjustment for poor health affected the risk estimates only modestly . Subjects who , during follow-up , reduced their physical activity level from the highest or the intermediate activity level to a sedentary level had a higher risk of hip fracture than did those who remained moderately physically active at the intermediate level ( multivariate adjusted RR = 2.19 , 95 % CI : 1.00 , 4.84 and RR = 1.89 , 95 % CI : 1.21 , 2.95 , for reduction from the highest and intermediate levels , respectively ) . There was no evidence of a fracture-protective effect from increasing physical activity . In conclusion , moderate levels of physical activity appear to provide protection against later hip fracture . Decline in the physical activity level over time is an important risk factor for hip fracture",
"BACKGROUND Physical activity contributes to improve health and quality of life . However , the prevalence of sedentary lifestyle is elevated after an acute coronary syndrome . METHODS A r and omized controlled trial was performed to evaluate the impact of a pedometer-based program associated with a socio-cognitive intervention on physical activity behaviour , cardiovascular risk factors , and quality of life during the year after an acute coronary syndrome event . During hospitalization , we r and omized 32 patients to an experimental group and 33 patients to a usual care group . The experimental intervention included 6 consultations with a clinical nurse specialist during 12 months . RESULTS Groups characteristics were comparable . At baseline , the percentage of participants considered in the active range category was similar between groups ( 31 % vs 41 % ; P = 0.915 ) . However , the proportion of participants who were still active was greater in the experimental group than in the usual care group at 6 , 9 , and 12 months follow-up ( 75 % vs 41 % ; 68 % vs 36 % , and 83 % vs 55 % , respectively ; P overall quality of life and in health and the functioning scores were different between groups ( interaction effects [ groups by time ] P = 0.048 and P = 0.036 , respectively ) . CONCLUSIONS The use of a pedometer concomitantly with a socio-cognitive intervention improves adherence to physical activity and quality of life during the year after an acute coronary syndrome event . This finding is relevant because physical activity and quality of life are a great concern in preventive cardiology . These results support applying this innovative approach in cardiac rehabilitation programs",
"PURPOSE This study examined the effects of walking speed on the accuracy and reliability of 10 pedometers : Yamasa Skeletone ( SK ) , Sportline 330 ( SL330 ) and 345 ( SL345 ) , Omron ( OM ) , Yamax Digiwalker SW-701 ( DW ) , Kenz Lifecorder ( KZ ) , New Lifestyles 2000 ( NL ) , Oregon Scientific ( OR ) , Freestyle Pacer Pro ( FR ) , and Walk4Life LS 2525 ( WL ) . METHODS Ten subjects ( 33 + /- 12 yr ) walked on a treadmill at various speeds ( 54 , 67 , 80 , 94 , and 107 m x min-1 ) for 5-min stages . Simultaneously , an investigator determined steps by a h and counter and energy expenditure ( kcal ) by indirect calorimetry . Each br and was measured on the right and left sides . RESULTS Correlation coefficients between right and left sides exceeded 0.81 for all pedometers except OR ( 0.76 ) and SL345 ( 0.57 ) . Most pedometers underestimated steps at 54 m x min-1 , but accuracy for step counting improved at faster speeds . At 80 m x min-1 and above , six models ( SK , OM , DW , KZ , NL , and WL ) gave mean values that were within + /- 1 % of actual steps . Six pedometers displayed the distance traveled . Most of them estimated mean distance to within + /- 10 % at 80 m x min-1 but overestimated distance at slower speeds and underestimated distance at faster speeds . Eight pedometers displayed kilocalories , but except for KZ and NL , it is unclear whether this should reflect net or gross kilocalories . If one assumes they display net kilocalories , the general trend was an overestimation of kilocalories at every speed . If one assumes they display gross kilocalorie , then seven of the eight pedometers were accurate to within + /-30 % at all speeds . CONCLUSION In general , pedometers are most accurate for assessing steps , less accurate for assessing distance , and even less accurate for assessing kilocalories",
"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",
"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",
"OBJECTIVES We sought to estimate the effects of recreational physical activity and back exercises on low back pain , related disability , and psychological distress among patients r and omized to chiropractic or medical care in a managed care setting . METHODS Low back pain patients ( n=681 ) were r and omized and followed for 18 months . Participation in recreational physical activities , use of back exercises , and low back pain , related disability , and psychological distress were measured at baseline , at 6 weeks , and at 6 , 12 , and 18 months . Multivariate logistic regression modeling was used to estimate adjusted associations of physical activity and back exercises with concurrent and subsequent pain , disability , and psychological distress . RESULTS Participation in recreational physical activities was inversely associated -- both cross-sectionally and longitudinally -- with low back pain , related disability , and psychological distress . By contrast , back exercise was positively associated -- both cross-sectionally and longitudinally -- with low back pain and related disability . CONCLUSIONS These results suggest that individuals with low back pain should refrain from specific back exercises and instead focus on nonspecific physical activities to reduce pain and improve psychological health",
"OBJECTIVE To investigate whether a 12-week pedometer-based exercise counseling strategy is feasible and effectively enhances daily physical activity in outclinic Chronic Obstructive Pulmonary Disease ( COPD ) patients who do not participate in a rehabilitation program in a controlled way . METHODS 35 outclinic COPD patients ( 21 males , mean age 62 years , GOLD I-III , mean FEV(1)% predicted 64.7 ) were r and omized for a 12-week individual pedometer-based exercise counseling program promoting daily physical activities or usual care . Daily physical activity ( DigiWalker SW-200 ) , physical fitness , health-related quality of life , self-efficacy , fatigue , depression and motivation to be physically active were assessed before and after the intervention . RESULTS After the intervention , COPD patients in the exercise counseling group showed a significant increase in their mean number of steps/day ( from 7087 to 7872 ) , whereas the usual care group showed a decrease ( from 7539 to 6172 ) . Significant differences favoring the exercise counseling group were demonstrated in arm strength , leg strength , health-related quality of life and intrinsic motivation to be physically active . CONCLUSION Our study shows that a 12-week pedometer-based exercise counseling strategy is feasible and effectively enhances daily physical activity , physical fitness , health-related quality of life and intrinsic motivation in outclinic COPD patients who do not participate in a rehabilitation program . PRACTICE IMPLICATION S The feasibility of our exercise counseling strategy is good and patients were motivated to participate",
"STUDY OBJECTIVE To examine the effects of 30 min of self-paced , non-supervised , brisk walking , 5 days per week on the health and fitness of people aged 50 - 65 years . DESIGN R and omized controlled trial . Members of the intervention group ( n = 21 ) were directed to walk briskly for 30 min , 5 days per week , for 12 weeks . Individuals were given the choice to complete the 30 min of walking in one session or in shorter bouts of no less than 10 min . They were asked to record in a diary the time spent walking and the number of steps taken during a single walk using a pedometer . Participants in the control group ( n = 10 ) were asked to maintain their habitual lifestyle and not change their activity or dietary habits . Measurements of body mass index ( BMI ) , waist/hip ratio ( WHR ) , blood pressure , functional capacity , total cholesterol , triglyceride , and lipoprotein subfractions were taken before and after the program . Changes in 10-year risk estimate for coronary heart disease and stroke were calculated using Framingham risk equations . SETTING Three urban general practice s patients : 31 healthy , sedentary 50- to 65-year-old participants recruited following contact by their general practitioner . MAIN RESULTS The mean time spent walking by the intervention group was 27.72 ( + /-9.79 ) min/day : their adherence to the protocol was 90.3 % . Significant decreases in systolic and diastolic blood pressure , reduction in stroke risk , and increased functional capacity were found within the walking group between baseline and 12-week measurements . No changes were found in these parameters within the control group . Significant reductions in 10-year risk of CHD were observed in both groups . No significant changes were found in lipid levels or anthropometric measurements in either group . CONCLUSIONS The study provides evidence for the benefit to fitness and cardiovascular risk of the \" 30-min brisk walking , 5 days a week \" message to people aged 50 - 65 years who participated in an unsupervised home-based walking program . Further study to overcome the problem of poor recruitment and determine the minimum effective dose of exercise to improve cardiovascular risk prediction scores is required"
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The objective of this study is to provide a critical overview of available instruments to assess impairments in patients with rheumatic disorders , and to recommend reliable and valid instruments for use in allied health care and rehabilitation medicine . A computer-aided literature search ( 1982–2004 ) in several data bases was performed to identify studies focusing on the clinimetric properties of instruments design ed to assess impairments in function in patients with rheumatic disorders . Data on intra-rater reliability , inter-rater reliability and construct validity were extracted in a st and ardized way . Explicit criteria were applied for reliability and validity . Results : The search identified a total of 49 instruments to assess impairments in functions in patients with rheumatic disorders ; 19 met the criteria for reliability , 22 met the criteria for validity , and 11 out of the 49 appeared to meet the criteria for both reliability and validity . In summary , evidence of both reliability and validity was only found for 11 out of 49 instruments for the assessment of impairments in patients with rheumatic disorders . Only a limited number of the identified instruments for the assessment of impairments is both reliable and valid . Allied health care professionals should be cautious in the selection of measurement instruments to assess their patients
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"Health status measures are conceptually relevant to the assessment of clinical outcome in the rheumatic diseases , but their ability to detect meaningful changes in health has not been clearly demonstrated . This report describes the performance of a self-administered health status question naire in a r and omized , double-blind , 21-week comparison of placebo , oral gold , and injectable gold in rheumatoid arthritis patients . Outcome was assessed by st and ard clinical measures , including joint count , grip strength , and laboratory tests , and by the Arthritis Impact Measurement Scales , a reliable and valid health status measure that assesses physical disability , psychological status , and pain . Data from the clinical and health status measures produced highly similar conclusions : injectable and oral gold are more effective than placebo for rheumatoid arthritis , and injections are slightly more effective than oral gold . The health status measure was thus quite sensitive to clinical ly meaningful drug-induced improvements . These findings provide justification for the further application of health status measures to clinical trials of chronic disease",
"OBJECTIVE To determine the discriminant validity of the core set of outcome measures proposed by the American College of Rheumatology ( ACR ) and the Outcome Measures in Clinical Trials ( OMERACT ) conference committee to be used in clinical trials of rheumatoid arthritis ( RA ) . METHODS Utilizing data from a multicenter r and omized double-blind clinical trial of low-dose cyclosporine and placebo in RA , we estimated the relative efficiency ( RE ) of measures to detect a treatment effect ( relative to tender joint count , which was assigned a value of 1 ) . Four pain measures ( 10-cm visual analog scale [ VAS ] , 5-point categorical scale , Health Assessment Question naire [ HAQ ] pain index , Arthritis Impact Measurement Scales [ AIMS ] pain score ) and 3 quality -of-life measures ( Problem Elicitation Technique [ PET ] , HAQ , AIMS ) were compared . RESULTS Physician and patient global measures were the most responsive instruments , although neither was statistically superior to tender joint count . Swollen joint count , grip strength , pain measured on a 10-cm VAS , and functional status as measured by the PET and HAQ were all of intermediate responsiveness . Morning stiffness , 5-point pain scale , and erythrocyte sedimentation rate were the least responsive instruments . CONCLUSION This study provides further evidence to support the core set of outcome measures proposed by the ACR and OMERACT",
"Observational and longitudinal observational studies ( LOS ) provide essential information about the course and outcome of rheumatic disorders that can not be provided by r and omized controlled trials , and they constitute the major clinical scientific communication in rheumatology . There has been no consensus as to the full and appropriate content of LOS . This report defines a core set of domains and reporting requirements for LOS . At the 1998 OMERACT IV Conference a consensus process evaluated the literature of rheumatology in light of the constructs , variables , and outcomes of rheumatology by using introductory lectures , nominal groups , and plenary sessions . The result of this process was to identify 5 \" core \" domains that should be included in every LOS : Health Status , Disease Process , Damage , Mortality , and Toxicity/Adverse Reactions . Two additional domains , Work Disability and Costs , were recognized as important , but need not be used in all LOS . Eleven subdomains were identified that divided the domains into convenient clinical and conceptual units . A set of reporting requirements was also determined . The core recommendations , which follow on the WHO ICIDH-2 outline , are not disease-specific ; the substitution of different \" disease process \" and \" damage \" measures make them suitable for many rheumatic disorders . The core set is intended to serve as a core for LOS in almost all rheumatic conditions",
"Is the modified aneroid sphygmomanometer a valid instrument to measure isometric quadriceps strength ? Three techniques were compared : the cuff method , in which the original cuff and bladder were folded then secured by rubber b and s ; the bag method , in which the folded bladder was secured in a sewn bag ; and a st and ard method , employing weights . Using a design to control for method and order of measurement , five physiotherapists measured quadriceps muscle strength in five rheumatoid patients . The design features explained 97 % of the variation amongst the measurements . Order of observation and the observers had no effect on the measurements . Patients were quite different and methods of measurement were different . The cuff and bag methods obtained higher readings than the weights , and the bag readings were higher than the cuff . Compared to the st and ard weights , the sphygmomanometer methods were : equally sensitive and reproducible , performed in 16th of the time , independent of gravity and potentially adaptable to 24 different muscle groups",
"OBJECTIVE To determine the reliability , validity , and responsiveness of the modified Kap and ji index ( MKI ) . DESIGN Prospect i ve study . A cohort of patients planned for surgery of the wrist and /or fingers was evaluated within 48 hours before surgery and at least 6 months after surgery . SETTING Patients were in hospitalized or private care in France . PARTICIPANTS Patients with rheumatoid arthritis according to criteria of the American College of Rheumatology . Forty-two patients ( 36 women ; mean age , 57.5y ; range , 22 - 80y ) were included in the reliability study . Fifty patients ( 42 women ; mean age , 54.18y ; range , 19 - 77y ) were included in the validity study . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Clinical outcome measures included the MKI , the overall mobility score of the wrist and fingers , the finger mobility score , a visual analog scale ( VAS ) of pain in the h and s and wrists , morning stiffness duration , total score of tenderness , total score of swelling , grip and pinch strength , the H and Functional Index ( HFI ) , and the Cochin rheumatoid h and disability scale . Reliability was studied with the intraclass correlation coefficient ( ICC ) and the Bl and and Altman method . Convergent and divergent validity were assessed with the Spearman correlation coefficient . Responsiveness was assessed by the paired t test , the effect size , and the st and ardized response mean ( SRM ) . RESULTS Interobserver reliability was good with an ICC of.90 , and the Bl and and Altman analysis showed homogeneous distribution of the differences , with no systematic trend . The MKI correlated well with the other mobility measures ( HFI , the finger mobility score measured with the finger goniometer ) , indicating a good convergent validity , and the expected divergent validity with the other outcome measures ( grip and pinch strength , total score of swelling , total score of Ritchie Articular Index , Cochin scale , VAS of pain ) was observed . The 50 patients in the validity study were evaluated twice , before and after surgery , at a mean interval + /- st and ard deviation of 7.16+/-2.10 months ( range , 6 - 15mo ) . Thirty-six patients ( 72 % ) were very satisfied or satisfied with the results of surgery , 7 ( 14 % ) were not satisfied or dissatisfied , and 7 ( 14 % ) were dissatisfied or very dissatisfied . The SRM and effect size values of the MKI were -.19 and -.10 , respectively . Individual changes in the score had the best correlation ( r(s)=.51 ) with overall patient satisfaction . CONCLUSIONS The MKI has excellent validity and reliability . Individual changes in the score are clinical ly relevant . This index can be used in clinical practice and in therapeutic trials ; it needs further study concerning its use for h and surgery",
"OBJECTIVES To determine the agreement of scores on the original visual analog scale ( VAS ) or Likert scale of the Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , Bath Ankylosing Spondylitis Functional Index ( BASFI ) , and Dougados Functional Index ( DFI ) with scores on a numerical rating scale ( NRS ) . To assess the reproducibility and responsiveness of the instruments with the original scale and NRS . METHODS Five hundred thirty-six patients with ankylosing spondylitis from the Netherl and s , Mexico , and Switzerl and completed a question naire in which all questions from the BASDAI , BASFI , and DFI were presented twice in r and om order with an 11-point NRS and either a 10-cm VAS ( BASDAI and BASFI ) or a 5-point Likert scale ( DFI ) . Agreement of scores using Bl and -Altman plots and intraclass correlation coefficients ( ICCs ) , reproducibility using ICCs , and responsiveness were assessed . RESULTS Large variability between the scores on the original scales and the NRS was found in individual questions of all 3 question naires , although total scores showed ICCs of at least 0.88 . Reproducibility of all answer modalities showed low ICCs in individual questions , but moderate to good ICCs in total scores ( Dutch group 0.62 - 0.89 ; Mexican group 0.53 - 0.72 ) . Moderate to large effects ( 0.48 - 1.04 ) were found in responsiveness scores in the 3 question naires . No major differences in reproducibility and responsiveness between the answer modalities were found . CONCLUSION Although large variability between the scores on the original answer scales and the NRS was observed , the BASDAI , BASFI , and DFI can be administered with an NRS , which does not show important differences compared with the original scales",
"An articular index was devised for the sequential assessment of patients with osteoarthritis ( OA ) . Forty-eight joint units , chosen to reflect the characteristic pattern of the disease , were scored for tenderness on pressure or movement on a 4-point scale . Four observers examined patients to assess inter- and intraobserver error . The index was highly reproducible both within and between observers ; intraobserver error was , however , significantly smaller . In a double-blind , cross-over trial the index was sufficiently sensitive to detect a statistically significant difference between the responses of patients with OA to an anti-inflammatory agent and to a simple analgesic . It is likely to be a useful addition to current methods of measurement in osteoarthritis",
"To assess the effect of grading of tenderness on the interrater reliability of the Ritchie articular index ( RAI ) , 3 physicians recorded independent joint scores on each of 18 patients , examined in r and om order . Our results indicate that close agreement ( Intraclass Correlation Coefficient = 0.85 ) can be achieved on global RAI scores , and that raters can achieve reasonable agreement ( kappa = 0.40 - 0.59 ) on the absolute presence or absence of tenderness of individual joints . By contrast , interrater agreement hardly exceeds the chance level ( kappa = 0.008 - 0.148 ) when degree of tenderness is independently assessed . The grading system of the RAI may thus be implicated as an important source of the instrument 's interrater error",
"This study represents a long-term effort to find optimal techniques for evaluating outcome in patients who have undergone total joint arthroplasty . Sensitivity of five health status question naires was studied in a longitudinal evaluation of orthopedic surgery . The question naires ( Arthritis Impact Measurement Scales [ AIMS ] , Functional Status Index [ FSI ] , Health Assessment Question naire [ HAQ ] , Index of Well Being [ IWB ] , and Sickness Impact Profile [ SIP ] ) were administered to 38 patients with end-stage arthritis at three points in time : two weeks before hip or knee arthroplasty , and at three-month and 12- to 15-month follow-up . Response values ( i.e. , changes within patients ) were calculated on four scales : global health , pain , mobility , and social function . By the three-month follow-up , most instruments detected large mean responses in global health , pain scores , and mobility . Smaller changes on these scales were found between three and 12 to 15 months . Social function showed small to modest gains at successive follow-ups . St and ardized response means were calculated to assess sensitivity to detect change . Confidence intervals for these indices were constructed using a jackknife procedure , and significance tests were performed by pairing selected indices . Finally , the study projected sample sizes required to assess a new therapy , using each response . These statistical tools facilitated comparisons among instruments and may prove useful in other setting",
"Summary A simple pressure dolorimeter for the detection and quantification of joint tenderness is described and evaluated . The pressure dolorimeter was more sensitive than a modified Ritchie Index in measuring degree of joint tenderness and as sensitive in detecting tender joints . The interobserver error of the pressure dolorimeter was low , and in a drug withdrawal study , the pressure dolorimeter was able to detect change in joint tenderness whereas the conventional Ritchie Index was not . These results suggest that the pressure dolorimeter is a simple , reliable and sensitive instrument for measuring joint tenderness in patients with inflammatory joint disease . It is also inexpensive and readily available",
"Five health status instruments were administered in r and om order to 50 arthritis patients before and after total joint arthroplasty . Relative efficiency and sensitivity in measurement of change in pain , mobility and physical function , social role and social activity , and global health were assessed . The instruments had highly correlated scores , but had differences in certain dimensions . Inter-instrument differentials were larger for social and global outcomes than for pain or mobility . NO single instrument consistently outperformed the others . A method for determining relative efficiency is described",
"OBJECTIVE Evaluation of joint range of motion ( ROM ) is important in the therapeutic approach to patients with rheumatoid arthritis ( RA ) . The reliability , construct validity and sensitivity to change of the Escola Paulista de Medicina (EPM)--range of motion scale that measures 10 distinct movements of small and large joints were examined . METHODS Fifty patients with active RA who were participating in an inpatient multidisciplinary treatment program were examined by 2 investigators . Twenty-five of the patients were examined both at admission and at discharge from the hospital . RESULTS The mean EPM-ROM score at study entry was 11.52 ( SD + /- 3.80 ) . The intra and inter-observer reliability of the EPM-ROM scale was high , with correlations of r = 0.91 and r = 0.85 , respectively . There was a good correlation between the EPM-ROM scale and measures of functional ability . Correlations with measures of disease activity were poor . After a mean duration of the treatment program of 4.2 weeks , patients generally improved in variables of functional status and disease activity . The improvement of the EPM-ROM score ( mean difference 1.58 , 95 % CI 0.84 - 2.32 ) was generally larger than improvement in other variables of functional status . CONCLUSION The EPM-ROM scale is a reliable instrument , and according to its correlation with measures of functional status , relevant to the performance of activities of daily living . It showed a good response to improvement of functional status and disease activity and was more sensitive to changes than other variables of functional status",
"Three widely used depression scales -- the Beck Depression Inventory ( BDI ) , Center for Epidemiological Studies Depression scale ( CES-D ) , and General Well-Being Schedule depression subscale (GWB-D)--were studied in rheumatoid arthritis ( RA ) . Twenty-three rheumatologists identified 19 of the 45 items on these three question naires as likely to differ in patients with RA and control subjects because of the presence of RA , regardless of psychological status . Responses to 13 of these 19 individual scale items , design ated as \" RA-related items , \" differed significantly in 41 RA patients versus 57 age-matched control subjects . Only three of the other 26 items differed significantly in the two groups . These data extend evidence that responses of people with RA on widely used depression scales might be affected by somatic disease regardless of psychological status",
"Health status measures are being used with increasing frequency in clinical research . Up to now the emphasis has been on the reliability and validity of these measures . Less attention has been given to the sensitivity of these measures for detecting clinical change . As health status measures are applied more frequently in the clinical setting , we need a useful way to estimate and communicate whether particular changes in health status are clinical ly relevant . This report considers effect sizes as a useful way to interpret changes in health status . Effect sizes are defined as the mean change found in a variable divided by the st and ard deviation of that variable . Effect sizes are used to translate “ the before and after changes ” in a “ one group ” situation into a st and ard unit of measurement that will provide a clearer underst and ing of health status results . The utility of effect sizes is demonstrated from four different perspectives using three health status data sets derived from arthritis population s administered the Arthritis Impact Measurement Scales ( AIMS ) . The first perspective shows how general and instrument-specific benchmarks can be developed and how they can be used to translate the meaning of clinical change . The second perspective shows how effect sizes can be used to compare traditional clinical measures with health status measures in a st and ard clinical drug trial . The third application demonstrates the use of effect sizes when comparing two drugs tested in separate drug trials and shows how they can facilitate this type of comparison . Finally , our health status results show how effect sizes can supplement st and ard statistical testing to give a more complete and clinical ly relevant picture of health status change . We conclude that effect sizes are an important tool that will facilitate the use and interpretation of health status measures in clinical research in arthritis and other chronic diseases",
"The intra-observer , inter-observer , day-to-day , week-to-week and diurnal variations in grip strength measurement have been studied in patients with rheumatoid arthritis . In addition , the changes in grip strength measurements in a double-blind , cross-over trial of Sodium Salicylate and Prednisolone are reported . An intra-observer error of up to 9 mmHg was found and , in addition , there was also considerable variation in grip strength measurements between different observers . Grip strength is responsive to Sodium Salicylate and Prednisolone therapy but the change in association with the former was minimal — indicating insensitivity of the test . In clinical trials , measurement of grip strength should not only be performed by one observer for each patient but measurements should be made at the same time of day because of its diurnal variation . The inherent errors in the method should be considered when interpreting results of grip strength measurement in such trials",
" We describe an index of functional impairment and a system of scoring joint tenderness for use in the assessment of ankylosing spondylitis . The functional index consists of 20 questions and the articular index is based on the scoring of a total of 10 joint responses after movement or firm digital pressure . These indices are simple to establish and not time consuming . They have a high degree of intra- and interobserver reproducibility . The indices showed changes in short term clinical trials of antiinflammatory drugs ; these changes were highly correlated with the patient 's overall assessment of his own clinical condition",
"The histopathological characteristic of ankylosing spondylitis ( AS ) is the presence of chronic enthesitis . Our aim was to develop a clinical measurement of the severity of tenderness over entheses . The scoring system was based on the patients ' response to palpation over entheses easily accessible to examination . The enthesis index ( EI ) correlated with pain ( r = 0.67 , p less than 0.01 ) and stiffness ( r = 0.46 , p less than 0.05 ) scores . A single , blind , crossover study was conducted to determine the sensitivity of the index to change in clinical state associated with non-steroidal antirheumatic drug therapy and to record the interobserver variability . The index showed significantly lower scores after one week 's drug treatment ( p less than 0.05 ) . The EI is a convenient , non-invasive measure of disease severity in patients with AS . Potential applications include the assessment of enthesitis in other polyarthritides and a means of distinguishing clinical ly between severity of enthesitis and synovitis in different types of polyarthritis ",
"A simple method of assessing ' index of disease activity ' ( IDA ) in rheumatoid arthritis ( RA ) using a multivariate analysis ( MVA ) comprising morning stiffness ( MS ) , pain scale ( PS ) , grip strength ( GS ) , articular index ( AI ) , haemoglobin ( Hb ) and erythrocyte sedimentation rate ( ESR ) is described . The IDA of 99 patients with RA was assessed using MVA . The method could be used reliably and readily for r and om or longitudinal assessment , in drug trials and for comparing disease activity with other objective indices",
"We assessed whether a disease-specific , self-administered question naire could replace a generic instrument as an outcome tool after total hip replacement , and tested the validity and reliability of the Swedish WOMAC osteoarthritis index . 58 patients operated on with total hip arthroplasty 2 - 10 years ago were r and omized to the study . All patients were asked to answer one disease-specific question naire ( WOMAC osteoarthritis index ) and two generic instruments ( NHP and SF-36 ) in the same week . The procedure was repeated after 4 weeks . We tested content validity , construct validity , criterion validity , test-retest reliability and internal consistency reliability according to total score , domains and items . We found that both the generic instruments ( NHP and SF-36 ) and the disease-specific test ( WOMAC ) had a high validity , i.e. , measuring what they were supposed to measure ( high validity ) . The question naires were also reproducible over time ( high reliability ) . We suggest the Swedish WOMAC to be used after total hip arthroplasty in future studies",
"OBJECTIVE To test the precision of a new electronic method for measuring joint tenderness . METHOD Joint tenderness was measured in 30 patients with rheumatoid arthritis , using an electronic dolorimeter . The results were compared with joint tenderness counts , which were made according to the American Rheumatism Association ( ARA ) methods . RESULTS The intra-observer variability using the electronic method was significantly decreased compared with the conventional ARA joint tenderness counts . CONCLUSION The electronic method is more efficient for use in clinical trials than is the conventional ARA joint tenderness count",
"OBJECTIVE To investigate the validity of the 28-joint count for assessment of joint involvement in patients with rheumatoid arthritis ( RA ) . METHODS Joint involvement as determined by the 28- and the 66/68-joint count was compared using data from 735 prospect ively studied RA patients . RESULTS The joints included in the 28-joint count were more commonly involved than other joints , and findings from the 28-joint count correlated highly with those from the 66/68-joint count in all analyses . CONCLUSION The 28-joint count is a reliable and valid measure for joint assessment . It is easier to perform than the 66/68-joint count , and it addresses the joints that are critically involved"
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411744e8-06ff-11f0-808a-c43d1ab1c353
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Policy Points Social policies might not only improve economic well-being , but also health . Health policy experts have therefore advocated for investments in social policies both to improve population health and potentially reduce health system costs . Since the 1960s , a large number of social policies have been experimentally evaluated in the United States . Some of these experiments include health outcomes , providing a unique opportunity to inform evidence -based policymaking . Our comprehensive review and meta- analysis of these experiments find suggestive evidence of health benefits associated with investments in early life , income support , and health insurance interventions . However , most studies were underpowered to detect health outcomes . CONTEXT Insurers and health care providers are investing heavily in nonmedical social interventions in an effort to improve health and potentially reduce health care costs . METHODS We performed a systematic review and meta- analysis of all known r and omized social experiments in the United States that included health outcomes . We review ed 5,880 papers , reports , and data sources , ultimately including 61 publications from 38 r and omized social experiments . After synthesizing the main findings narratively , we conducted risk of bias analyses , power analyses , and r and om-effects meta-analyses where possible . Finally , we used multivariate regressions to determine which study characteristics were associated with statistically significant improvements in health outcomes . FINDINGS The risk of bias was low in 17 studies , moderate in 11 , and high in 33 . Of the 451 parameter estimates reported , 77 % were underpowered to detect health outcomes . Among adequately powered parameters , 49 % demonstrated a significant health improvement , 44 % had no effect on health , and 7 % were associated with significant worsening of health . In meta-analyses , early life and education interventions were associated with a reduction in smoking ( odds ratio [ OR ] = 0.92 , 95 % confidence interval [ CI ] 0.86 - 0.99 ) . Income maintenance and health insurance interventions were associated with significant improvements in self-rated health ( OR = 1.20 , 95 % CI 1.06 - 1.36 , and OR = 1.38 , 95 % CI 1.10 - 1.73 , respectively ) , whereas some welfare-to-work interventions had a negative impact on self-rated health ( OR = 0.77 , 95 % CI 0.66 - 0.90 ) . Housing and neighborhood trials had no effect on the outcomes included in the meta-analyses . A positive effect of the trial on its primary socioeconomic outcome was associated with higher odds of reporting health improvements . We found evidence of publication bias for studies with None findings . CONCLUSIONS Early life , income , and health insurance interventions have the potential to improve health . However , many of the included studies were underpowered to detect health effects and were at high or moderate risk of bias . Future social policy experiments should be better design ed to measure the association between interventions and health outcomes
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"BACKGROUND The question of whether neighborhood environment contributes directly to the development of obesity and diabetes remains unresolved . The study reported on here uses data from a social experiment to assess the association of r and omly assigned variation in neighborhood conditions with obesity and diabetes . METHODS From 1994 through 1998 , the Department of Housing and Urban Development ( HUD ) r and omly assigned 4498 women with children living in public housing in high-poverty urban census tracts ( in which ≥40 % of residents had incomes below the federal poverty threshold ) to one of three groups : 1788 were assigned to receive housing vouchers , which were redeemable only if they moved to a low-poverty census tract ( where counseling on moving ; 1312 were assigned to receive unrestricted , traditional vouchers , with no special counseling on moving ; and 1398 were assigned to a control group that was offered neither of these opportunities . From 2008 through 2010 , as part of a long-term follow-up survey , we measured data indicating health outcomes , including height , weight , and level of glycated hemoglobin ( HbA(1c ) ) . RESULTS As part of our long-term survey , we obtained data on body-mass index ( BMI , the weight in kilograms divided by the square of the height in meters ) for 84.2 % of participants and data on glycated hemoglobin level for 71.3 % of participants . Response rates were similar across r and omized groups . The prevalences of a BMI of 35 or more , a BMI of 40 or more , and a glycated hemoglobin level of 6.5 % or more were lower in the group receiving the low-poverty vouchers than in the control group , with an absolute difference of 4.61 percentage points ( 95 % confidence interval [ CI ] , -8.54 to -0.69 ) , 3.38 percentage points ( 95 % CI , -6.39 to -0.36 ) , and 4.31 percentage points ( 95 % CI , -7.82 to -0.80 ) , respectively . The differences between the group receiving traditional vouchers and the control group were not significant . CONCLUSIONS The opportunity to move from a neighborhood with a high level of poverty to one with a lower level of poverty was associated with modest but potentially important reductions in the prevalence of extreme obesity and diabetes . The mechanisms underlying these associations remain unclear but warrant further investigation , given their potential to guide the design of community-level interventions intended to improve health . ( Funded by HUD and others . )",
"The research design of the r and omised controlled trial is primarily associated today with medicine . It tends either to be ignored or regarded with suspicion by many in such disciplines as health promotion , public policy , social welfare , criminal justice , and education . However , all professional interventions in people 's lives are subject to essentially the same questions about acceptability and effectiveness . As the social reformers Sidney and Beatrice Webb pointed out in 1932 , there is far more experimentation going on in “ the world sociological laboratory in which we all live ” than in any other kind of laboratory , but most of this social experimentation is “ wrapped in secrecy ” and thus yields “ nothing to science.”1 # # # Summary points Many social scientists argue that r and omised controlled trials are inappropriate for evaluating social interventions , but they ignore a considerable history , mainly in the United States , of the use of r and omised controlled trials to assess different approaches to public policy and health promotion A tradition of experimental sociology was well established by the 1930s , built on the early use of controlled experiments in psychology and education From the early 1960s to early 1980s r and omised experiments were considered the optimal design for evaluating public policy interventions in the United States , and major evaluations using this design were carried out This approach became less popular as policy makers reacted negatively to evidence of “ near zero ” effects Lessons to be learnt about implementing r and omised controlled trials in real life setting s include the difficulty of assessing complex multi-level interventions and the challenge of integrating qualitative data The Webbs argued for a more “ scientific ” social policy , with social scientists being trained in experimental methods and evaluations of social interventions being carried out by independent investigators . They were apparently unaware that a strong tradition in experimental sociology had already been established , mainly in the United States .",
"INTRODUCTION Lower-income Americans are suffering from declines in income , health , and longevity over time . Income and employment policies have been proposed as a potential non-medical solution to this problem . METHODS An interrupted time series analysis of state-level incremental supplements to the Earned Income Tax Credit ( EITC ) program was performed using data from 1993 to 2010 Behavioral Risk Factor Surveillance System surveys and state-level life expectancy . The cost effectiveness of state EITC supplements was estimated using a microsimulation model , which was run in 2015 . RESULTS Supplemental EITC programs increased health-related quality of life and longevity among the poor . The program costs about $ 7,786/ quality -adjusted life-year gained ( 95 % CI=$4,100 , $ 13,400 ) for the average recipient . This ratio increases with larger family sizes , costing roughly $ 14,261 ( 95 % CI=$8,735 , $ 19,716 ) for a family of three . CONCLUSIONS State supplements to EITC appear to be highly cost effective , but r and omized trials are needed to confirm these findings",
"Opportunity NYC-Family Rewards was the first conditional cash transfer , r and omized controlled trial for low-income families in the United States . From 2007 to 2010 , Family Rewards offered 2,377 New York City families cash transfers that were conditional upon their investments in education , preventive health care , and parental employment . Their health and other outcomes were compared to those of a control group of 2,372 families . The experiment led to a modest improvement in health insurance coverage and a large increase in the use of preventive dental care . It improved parents ' perception of their own health and levels of hope , mainly through improvements in reported financial well-being . While the program 's impacts on physical health were weaker , our study might not have captured effects on chronic disease risk that take longer to accrue . In the context of New York City 's operating social-safety-net programs , conditional cash transfers may have led to positive , albeit modest , improvements in the health of poor families",
"Abstract The r and omized controlled trial is commonly used by both epidemiologists and economists to test the effectiveness of public health interventions . Yet we have noticed differences in practice between the two disciplines . In this article , we propose that there are some underlying differences between the disciplines in the way trials are used , how they are conducted and how results from trials are reported and disseminated . We hypothesize that evidence -based public health could be strengthened by underst and ing these differences , harvesting best- practice across the disciplines and breaking down communication barriers between economists and epidemiologists who conduct trials of public health interventions",
"Policy Points : We take advantage of Oregon 's Medicaid lottery to gauge the causal effects of Medicaid coverage on mental health care , how effectively it addresses unmet needs , and how those effects differ for those with and without a history of depression . Medicaid coverage reduced the prevalence of undiagnosed depression by almost 50 % and untreated depression by more than 60 % . It increased use of medications and reduced the share of respondents reporting unmet mental health care needs by almost 40 % . There are likely to be substantial mental health consequences of policy decisions about Medicaid coverage for vulnerable population s. CONTEXT Exp and ing Medicaid to previously uninsured adults has been shown to increase detection and reduce the prevalence of depression , but the ways that Medicaid affects mental health care , how effectively it addresses unmet needs , and how those effects differ for those with and without a history of depression remain unclear . METHODS We take advantage of Oregon 's Medicaid lottery to gauge the causal effects of Medicaid coverage using a r and omized-controlled design , drawing on both primary and administrative data sources . FINDINGS Medicaid coverage reduced the prevalence of undiagnosed depression by almost 50 % and untreated depression by more than 60 % . It increased use of medications frequently prescribed to treat depression and related mental health conditions and reduced the share of respondents reporting unmet mental health care needs by almost 40 % . The share of respondents screening positive for depression dropped by 9.2 percentage points overall , and by 13.1 for those with preexisting depression diagnoses , with greatest relief in symptoms seen primarily in feeling down or hopeless , feeling tired , and trouble sleeping-consistent with the increase observed not just in medications targeting depression but also in those targeting sleep . CONCLUSIONS Medicaid coverage had significant effects on the diagnosis , treatment , and outcomes of a population with substantial unmet mental health needs . Coverage increased access to care , reduced the prevalence of untreated and undiagnosed depression , and substantially improved the symptoms of depression . There are likely to be substantial mental health consequences of policy decisions about Medicaid coverage for vulnerable population ",
"OBJECTIVES We examined whether Jobs First , a multicenter r and omized trial of a welfare reform program conducted in Connecticut , demonstrated increases in employment , income , and health insurance relative to traditional welfare ( Aid to Families with Dependent Children ) . We also investigated if higher earnings and employment improved mortality of the participants . METHODS We revisited the Jobs First r and omized trial , successfully linking 4612 participant identifiers to 15 years of prospect i ve mortality follow-up data through 2010 , producing 240 deaths . The analysis was powered to detect a 20 % change in mortality hazards . RESULTS Significant employment and income benefits were realized among Jobs First recipients relative to traditional welfare recipients , particularly for the most disadvantaged groups . However , although none of these reached statistical significance , all participants in Jobs First ( overall , across centers , and all subgroups ) experienced higher mortality hazards than traditional welfare recipients . CONCLUSIONS Increases in income and employment produced by Jobs First relative to traditional welfare improved socioeconomic status but did not improve survival",
"OBJECTIVES We used 37 years of follow-up data from a r and omized controlled trial to explore the linkage between an early educational intervention and adult health . METHODS We analyzed data from the High/Scope Perry Preschool Program ( PPP ) , an early school-based intervention in which 123 children were r and omized to a prekindergarten education group or a control group . In addition to exploring the effects of the program on health behavioral risk factors and health outcomes , we examined the extent to which educational attainment , income , family environment , and health insurance access mediated the relationship between r and omization to PPP and behavioral and health outcomes . RESULTS The PPP led to improvements in educational attainment , health insurance , income , and family environment Improvements in these domains , in turn , lead to improvements in an array of behavioral risk factors and health ( P = .01 ) . However , despite these reductions in behavioral risk factors , participants did not exhibit any overall improvement in physical health outcomes by the age of 40 years . CONCLUSIONS Early education reduces health behavioral risk factors by enhancing educational attainment , health insurance coverage , income , and family environments . Further follow-up will be needed to determine the long-term health effects of PPP",
"During the 1990s reforms to the US welfare system introduced new time limits on people 's eligibility to receive public assistance . These limits were developed to encourage welfare recipients to seek employment . Little is known about how such social policy programs may have affected participants ' health . We explored whether the Florida Family Transition Program r and omized trial , a welfare reform experiment , led to long-term changes in mortality among participants . The Florida program included a 24 - 36-month time limit for welfare participation , intensive job training , and placement assistance . We linked 3,224 participants from the experiment to 17 - 18 years of prospect i ve mortality follow-up data and found that participants in the program experienced a 16 percent higher mortality rate than recipients of traditional welfare . If our results are generalizable to national welfare reform efforts , they raise questions about whether the cost savings associated with welfare reform justify the additional loss of life",
"BACKGROUND Supported housing , integrating clinical and housing services , is a widely advocated intervention for homeless people with mental illness . In 1992 , the US Department of Housing and Urban Development ( HUD ) and the US Department of Veterans Affairs ( VA ) established the HUD-VA Supported Housing ( HUD-VASH ) program . METHODS Homeless veterans with psychiatric and /or substance abuse disorders or both ( N = 460 ) were r and omly assigned to 1 of 3 groups : ( 1 ) HUD-VASH , with Section 8 vouchers ( rent subsidies ) and intensive case management ( n = 182 ) ; ( 2 ) case management only , without special access to Section 8 vouchers ( n = 90 ) ; and ( 3 ) st and ard VA care ( n = 188 ) Primary outcomes were days housed and days homeless . Secondary outcomes were mental health status , community adjustment , and costs from 4 perspectives . RESULTS During a 3-year follow-up , HUD-VASH veterans had 16 % more days housed than the case management-only group and 25 % more days housed than the st and ard care group ( P housed than the st and ard care group ( P = .29 ) . The HUD-VASH group also experienced 35 % and 36 % fewer days homeless than each of the control groups ( P measures of psychiatric or substance abuse status or community adjustment , although HUD-VASH clients had larger social networks . From the societal perspective , HUD-VASH was 6200 US dollars ( 15 % ) more costly than st and ard care . Incremental cost-effectiveness ratios suggest that HUD-VASH cost 45 US dollars more than st and ard care for each additional day housed ( 95 % confidence interval , -19 US dollars to 108 US dollars ) . CONCLUSIONS Supported housing for homeless people with mental illness results in superior housing outcomes than intensive case management alone or st and ard care and modestly increases societal costs",
"Look After the Child Investing in children has been demonstrated to improve their lives , both during the school-age years and afterward , as assessed by outcomes such as employment and income ; furthermore , these investments often help those in the most need . Campbell et al. ( p. 1478 ) report that these investments can also lead to improved adult health . Results from a r and omized and intensive intervention that involved 122 children in four cohorts recruited in the 1970s suggest that full-day child care for the first 5 years of life has produced adults in their 30s with better metabolic and cardiovascular health measures . Large investments in preschool children ’s education , health care , and nutrition provide long-term health benefits . High- quality early childhood programs have been shown to have substantial benefits in reducing crime , raising earnings , and promoting education . Much less is known about their benefits for adult health . We report on the long-term health effects of one of the oldest and most heavily cited early childhood interventions with long-term follow-up evaluated by the method of r and omization : the Carolina Abecedarian Project ( ABC ) . Using recently collected biomedical data , we find that disadvantaged children r and omly assigned to treatment have significantly lower prevalence of risk factors for cardiovascular and metabolic diseases in their mid-30s . The evidence is especially strong for males . The mean systolic blood pressure among the control males is 143 millimeters of mercury ( mm Hg ) , whereas it is only 126 mm Hg among the treated . One in four males in the control group is affected by metabolic syndrome , whereas none in the treatment group are affected . To reach these conclusions , we address several statistical challenges . We use exact permutation tests to account for small sample sizes and conduct a parallel bootstrap confidence interval analysis to confirm the permutation analysis . We adjust inference to account for the multiple hypotheses tested and for nonr and om attrition . Our evidence shows the potential of early life interventions for preventing disease and promoting health",
"Does free medical care lead to better health than insurance plans that require the patient to shoulder part of the cost ? In an effort to answer this question , we studied 3958 people between the ages of 14 and 61 who were free of disability that precluded work and had been r and omly assigned to a set of insurance plans for three or five years . One plan provided free care ; the others required enrollees to pay a share of their medical bills . As previously reported , patients in the latter group made approximately one-third fewer visits to a physician and were hospitalized about one-third less often . For persons with poor vision and for low-income persons with high blood pressure , free care brought an improvement ( vision better by 0.2 Snellen lines , diastolic blood pressure lower by 3 mm Hg ) ; better control of blood pressure reduced the calculated risk of early death among those at high risk . For the average participant , as well as for subgroups differing in income and initial health status , no significant effects were detected on eight other measures of health status and health habits . Confidence intervals for these eight measures were sufficiently narrow to rule out all but a minimal influence , favorable or adverse , of free care for the average participant . For some measures of health in subgroups of the population , however , the broader confidence intervals make this conclusion less certain",
"Do children whose families bear a percentage of their health care costs reduce their use of ambulatory care compared with those families who receive free care ? If so , does the reduction affect their health ? To answer these questions , 1,844 children aged 0 to 13 years were r and omly assigned ( for a period of 3 or 5 years ) to one of 14 insurance plans . The plans differed in the percentage of their medical bills that families paid . One plan provided free care . The others required up to 95 % coinsurance subject to a + 1,000 maximum . Children whose families paid a percentage of costs reduced use by up to one third . For the typical child in the study , this reduction caused no significant difference in either parental perceptions of their child 's health or in physiologic measures of health . Confidence intervals are sufficiently narrow for most measures to rule out the possibility that large true differences went undetected . Nor were statistically significant differences observed for children at risk of disease . Wider confidence intervals for these comparisons , however , mean that clinical ly meaningful differences , if present , could have been undetected in certain subgroups",
"OBJECTIVE : Leverage an experimental study to determine whether gender or recent crime victimization modify the mental health effects of moving to low-poverty neighborhoods . METHODS : The Moving to Opportunity ( MTO ) study r and omized low-income families in public housing to an intervention arm receiving vouchers to subsidize rental housing in lower-poverty neighborhoods or to controls receiving no voucher . We examined 3 outcomes 4 to 7 years after r and omization , among youth aged 5 to 16 years at baseline ( n = 2829 ) : lifetime major depressive disorder ( MDD ) , psychological distress ( K6 ) , and Behavior Problems Index ( BPI ) . Treatment effect modification by gender and family ’s baseline report of recent violent crime victimization was tested via interactions in covariate-adjusted intent-to-treat and instrumental variable adherence-adjusted regression models . RESULTS : Gender and crime victimization significantly modified treatment effects on distress and BPI ( P Female adolescents in families without crime victimization benefited from MTO treatment , for all outcomes ( Distress B = –0.19 , P = .008 ; BPI B = –0.13 , P = .06 ; MDD B = –0.036 , P = .03 ) . Male adolescents in intervention families experiencing crime victimization had worse distress ( B = 0.24 , P = .004 ) , more behavior problems ( B = 0.30 , P higher MDD ( B = 0.022 , P = .16 ) versus controls . Other subgroups experienced no effect of MTO treatment . Instrumental variable estimates were similar but larger . CONCLUSIONS : Girls from families experiencing recent violent crime victimization were significantly less likely to achieve mental health benefits , and boys were harmed , by MTO , suggesting need for cross-sectoral program supports to offset multiple stressors",
"OBJECTIVES The health consequences of neighborhood poverty are a public health problem . Data were obtained to examine links between neighborhood residence and mental health outcomes . METHODS Moving to Opportunity was a r and omized , controlled trial in which families from public housing in high-poverty neighborhoods were moved into private housing in near-poor or nonpoor neighborhoods , with a subset remaining in public housing . At the 3-year follow-up of the New York site , 550 families were reinterviewed . RESULTS Parents who moved to low-poverty neighborhoods reported significantly less distress than parents who remained in high-poverty neighborhoods . Boys who moved to less poor neighborhoods reported significantly fewer anxious/depressive and dependency problems than did boys who stayed in public housing . CONCLUSIONS This study provides experimental evidence of neighborhood income effects on mental health",
"Analyses of data from a r and omized field experiment with 1,801 participants ( A.D. Vinokur , R.H. Price . & Y.Schul , 1995 ) examined the long-term effects of a job- search workshop ( JOBS ) and the independent effects of demographic and psychological factors on reemployment and mental health outcomes . Two years after the JOBS workshop , the experimental group had significantly higher levels of reemployment and monthly income , lower levels of depressive symptoms , lower likelihood of experiencing a major depressive episode in the last year , and better role and emotional functioning compared with the control group . Baseline job- search motivation and sense of mastery had both direct and interactive effects ( with experimental condition ) on reemployment and mental health outcomes , respectively . The interactive effects demonstrated larger benefits for those who had initial low levels of job- search motivation and mastery",
"Adult ( age 30 ) educational , economic , and social-emotional adjustment outcomes were investigated for participants in the Abecedarian Project , a r and omized controlled trial of early childhood education for children from low-income families . Of the original 111 infants enrolled ( 98 % African American ) , 101 took part in the age 30 follow-up . Primary indicators of educational level , economic status , and social adjustment were examined as a function of early childhood treatment . Treated individuals attained significantly more years of education , but income-to-needs ratios and criminal involvement did not vary significantly as a function of early treatment . A number of other indicators were described for each domain . Overall , the findings provide strong evidence for educational benefits , mixed evidence for economic benefits , and little evidence for treatment-related social adjustment outcomes . Implication s for public policy are discussed",
"The Oregon Medicaid lottery provided a unique opportunity to assess the causal impacts of health insurance on cancer screening rates within the framework of a r and omized controlled trial . Prior studies regarding the impacts of health insurance have almost always been limited to observational evidence , which can not be used to make causal inferences",
"Is no evidence better than any evidence when controlled studies are unethical ? Rigorous evidence on the health effects of social interventions is scarce1 2 despite calls for more evidence from r and omised studies .3 One reason for the lack of such experimental research on social interventions may be the perception among research ers , policymakers , and others that r and omised design s belong to the biomedical world and that their application to social interventions is both unethical and simplistic.4 Applying experimental design s to social interventions may be problematic but is not always impossible and is a desirable alternative to uncontrolled experimentation.3 However , even when r and omised design s have been used to evaluate social interventions , opportunities to incorporate health measures have often been missed.5 For example , income supplementation is thought to be a key part of reducing health inequalities,6 but rigorous evidence to support this is lacking because most r and omised controlled trials of income supplementation have not included health measures .5 Current moves to increase uptake of benefits offer new opportunities to establish the effects of income supplements on health . In attempting to design such a study , however , we found that r and omised or other controlled trials were difficult to justify ethically , and our eventual design was rejected by funders . # # # # Box 1 Attendance allowance A pilot study carried out by one of us ( RH ) showed substantial health gains among elderly people after receipt of attendance allowance . We therefore decided to pursue a full scale study of the health effects of income supplementation . ",
"IMPORTANCE Mothers and children living in adverse context s are at risk of premature death . OBJECTIVE To determine the effect of prenatal and infant/toddler nurse home visiting on maternal and child mortality during a 2-decade period ( 1990 - 2011 ) . DESIGN , SETTING , AND PARTICIPANTS A r and omized clinical trial was design ed originally to assess the home visiting program 's effect on pregnancy outcomes and maternal and child health through child age 2 years . The study was conducted in a public system of obstetric and pediatric care in Memphis , Tennessee . Participants included primarily African American women and their first live-born children living in highly disadvantaged urban neighborhoods , who were assigned to 1 of 4 treatment groups : treatment 1 ( transportation for prenatal care [ n = 166 ] ) , treatment 2 ( transportation plus developmental screening for infants and toddlers [ n = 514 ] ) , treatment 3 ( transportation plus prenatal/postpartum home visiting [ n = 230 ] ) , and treatment 4 ( transportation , screening , and prenatal , postpartum , and infant/toddler home visiting [ n = 228 ] ) . Treatments 1 and 3 were included originally to increase statistical power for testing pregnancy outcomes . For determining mortality , background information was available for all 1138 mothers assigned to all 4 treatments and all but 2 live-born children in treatments 2 and 4 ( n = 704 ) . Inclusion of children in treatments 1 and 3 was not possible because background information was missing on too many children . INTERVENTIONS Nurses sought to improve the outcomes of pregnancy , children 's health and development , and mothers ' health and life-course with home visits beginning during pregnancy and continuing through child age 2 years . MAIN OUTCOMES AND MEASURES All-cause mortality in mothers and preventable-cause mortality in children ( sudden infant death syndrome , unintentional injury , and homicide ) derived from the National Death Index . RESULTS The mean ( SE ) 21-year maternal all-cause mortality rate was 3.7 % ( 0.74 % ) in the combined control group ( treatments 1 and 2 ) , 0.4 % ( 0.43 % ) in treatment 3 , and 2.2 % ( 0.97 % ) in treatment 4 . The survival contrast of treatments 1 and 2 combined with treatment 3 was significant ( P = .007 ) ; the contrast of treatments 1 and 2 combined with treatment 4 was not significant ( P = .19 ) , and the contrast of treatments 1 and 2 combined with treatments 3 and 4 combined was significant ( post hoc P = .008 ) . At child age 20 years , the preventable-cause child mortality rate was 1.6 % ( 0.57 % ) in treatment 2 and 0.0 % ( SE not calculable ) in treatment 4 ; the survival contrast was significant ( P = .04 ) . CONCLUSIONS AND RELEVANCE Prenatal and infant/toddler home visitation by nurses is a promising means of reducing all-cause mortality among mothers and preventable-cause mortality in their first-born children living in highly disadvantaged setting s. TRIAL REGISTRATION clinical trials.gov Identifier : NCT00708695",
"In 1992 , the US Department of Housing and Urban Development ( HUD ) and the US Department of Veterans Affairs ( VA ) established the HUD-VA Supported Housing ( HUD-VASH ) Program to provide integrated clinical and housing services to homeless veterans with psychiatric and /or substance abuse disorders at 19 sites . At four sites , 460 subjects were r and omly assigned to one of the three groups : ( 1 ) HUD-VASH , with both Section 8 vouchers and intensive case management ; ( 2 ) case management only ; and ( 3 ) st and ard VA care . A previous publication found HUD-VASH result ed in superior housing outcomes but yielded no benefits on clinical outcomes . Since many participants missed prescheduled visits during the follow-up period and follow-up rates were quite different across the groups , we reanalyzed these data using multiple imputation statistical methods to account for the missing observations . Significant benefits were found for HUD-VASH in drug and alcohol abuse outcomes that had not previously been identified",
"OBJECTIVE People with psychiatric impairments ( primarily schizophrenia or a mood disorder ) are the largest and fastest-growing group of Social Security Disability Insurance ( SSDI ) beneficiaries . The authors investigated whether evidence -based supported employment and mental health treatments can improve vocational and mental health recovery for this population . METHOD Using a r and omized controlled trial design , the authors tested a multifaceted intervention : team-based supported employment , systematic medication management , and other behavioral health services , along with elimination of barriers by providing complete health insurance coverage ( with no out-of-pocket expenses ) and suspending disability review s. The control group received usual services . Paid employment was the primary outcome measure , and overall mental health and quality of life were secondary outcome measures . RESULTS Overall , 2,059 SSDI beneficiaries with schizophrenia , bipolar disorder , or depression in 23 cities participated in the 2-year intervention . The teams implemented the intervention package with acceptable fidelity . The intervention group experienced more paid employment ( 60.3 % compared with 40.2 % ) and reported better mental health and quality of life than the control group . CONCLUSIONS Implementation of the complex intervention in routine mental health treatment setting s was feasible , and the intervention was effective in assisting individuals disabled by schizophrenia or depression to return to work and improve their mental health and quality of life",
"When the GUIDE TO COMMUNITY PREVENTIVE SERVICES : Systematic Review s and Evidence -Based Recommendations ( the Guide ) is published in 2001 , it will represent a significant national effort in encouraging evidence -based public health practice in defined population s ( e.g. , communities or members of specific managed care plans ) . The Guide will make recommendations regarding public health interventions to reduce illness , disability , premature death , and environmental hazards that impair community health and quality of life . The Guide is being developed under the guidance of the Task Force on Community Preventive Services ( the Task Force)-a 15-member , nonfederal , independent panel of experts . Subject matter experts , method ologists , and scientific staff are supporting the Task Force in using explicit rules to conduct systematic literature review s of evidence of effectiveness , economic efficiency , and feasibility on which to base recommendations for community action . Contributors to the Guide are building on the experience of others to confront method ologic challenges unique to the assessment of complex multicomponent intervention studies with nonexperimental or nonr and omized design s and diverse measures of outcome and effectiveness . Persons who plan , fund , and implement population -based services and policies to improve health at the state and local levels are invited to scrutinize the work in progress and to communicate with contributors . When the Guide is complete , readers are encouraged to consider critically the value and relevance of its contents , the implementation of interventions the Task Force recommends , the ab and onment of interventions the Task Force does not recommend , and the need for rigorous evaluation of the benefits and harms of promising interventions of unknown effectiveness",
"Drawing on coping re sources theory , we evaluate the impact of a job search intervention on depressive symptoms in a r and omized field experiment at three follow-up periods covering two and one-half years . Baseline depressive symptoms , low social assertiveness , and financial hardship were identified as significant risk variables predicting depressive symptoms at follow-up . These variables then were used to identify high- and low-risk individuals in both experimental and control groups . Results indicated that the job search intervention had its primary impact on persons identified as being at higher risk for depression . Furthermore , the intervention had an impact on both the incidence and prevalence of more severe depressive symptoms among high-risk individuals",
"Background . Early education interventions have been forwarded as a means for reducing social disparities in income and health in adulthood . We explore whether a successful early education intervention , which occurred between 1985 and 1989 , improved the employment rates , earnings and health of blacks relative to whites through 2008 . Methods . We used data from Project STAR ( Student Teacher Achievement Ratio ) , a four-year multi-center r and omized controlled trial of reduced class sizes in Tennessee involving 11,601 students . Students were initially r and omized within 79 schools to classes with 22 - 25 or 13 - 17 students . We linked subject records to Social Security Administration ( SSA ) earnings and disability data collected between 1997 and 2008—when the majority of subjects were between the ages of 18 and 28 . We focused our analysis on annual , rather than cumulative , measures of earnings and employment because educational attainment after high school might reduce earnings through age 23 . We considered three or more years of statistically significant positive ( or negative ) annual impacts to be a meaningful effect . Results . Project STAR improved cognition and high school graduation rates . These benefits were primarily realized among low-income and minority students . These early education benefits did not translate into reduced disability cl aims in adulthood for treated subjects . However , exposure to small class size increased employment for blacks , and increased earnings for black males ( p in earnings for white males . However , white females exposed to small classes experienced a net decline in earnings and employment across the later years of follow up ( p earnings and employment for black males and earnings for white males , while reducing employment and earnings among white females",
"Limiting the number of students per classroom in the early years has been shown to improve educational outcomes . Improved education is , in turn , hypothesized to improve health . The authors examined whether smaller class sizes affect mortality through age 29 years and whether cognitive factors play a role . They used data from the Project Student Teacher Achievement Ratio , a 4-year multicenter r and omized controlled trial of reduced class sizes in Tennessee involving 11,601 students between 1985 and 1989 . Children r and omized to small classes ( 13 - 17 students ) experienced improved measures of cognition and academic performance relative to those assigned to regular classes ( 22 - 25 students ) . As expected , these cognitive measures were significantly inversely associated with mortality rates ( P mortality rates than those r and omized to regular size classes ( hazard ratio ( HR ) = 1.58 , 95 % confidence interval ( CI ) : 1.07 , 2.32 ) . The groups at risk included males ( HR = 1.73 , 95 % CI : 1.05 , 2.85 ) , whites/Asians ( HR = 1.68 , 95 % CI : 1.04 , 2.72 ) , and higher income students ( HR = 2.20 , 95 % CI : 1.06 , 4.57 ) . The authors speculate that small classes might produce behavior changes that increase mortality through young adulthood that are stronger than the protective effects of enhanced cognition",
"Homelessness affects HIV risk and health , but little is known about the longitudinal effects of rental assistance on the housing status and health of homeless and unstably housed people living with HIV/AIDS . Homeless/unstably housed people living with HIV/AIDS ( N = 630 ) were r and omly assigned to immediate Housing Opportunities for People with AIDS ( HOPWA ) rental assistance or customary care . Self-reported data , CD4 , and HIV viral load were collected at baseline , 6 , 12 , and 18 months . Results showed that housing status improved in both groups , with greater improvement occurring in the treatment group . At 18 months , 51 % of the comparison group had their own housing , limiting statistical power . Intent-to-treat analyses demonstrated significant reductions in medical care utilization and improvements in self-reported physical and mental health ; significant differential change benefiting the treatment group was observed for depression and perceived stress . Significant differences between homeless and stably housed participants were found in as-treated analyses for health care utilization , mental health , and physical health . HOPWA rental assistance improves housing status and , in some cases , health outcomes of homeless and unstably housed people living with HIV/AIDS",
"Background : Under current law , most Social Security Disability Insurance ( SSDI ) beneficiaries are not eligible for Medicare until 29 months after the Social Security Administration determines the onset of their disability . During this waiting period , > 1 in 5 lacks health insurance . This study investigated the effects of providing health care benefits on the health , employment , and other services of uninsured beneficiaries . Methods : New SSDI beneficiaries without health insurance were r and omly assigned to receive health care benefits , health care benefits plus additional supports , or a control group . Results : Compared with a control group , those provided health care benefits used more health care , had fewer unmet medical needs , spent less out of pocket on health care , and reported improved health . In addition , those provided the additional supports were more likely to look for work , but the supports did not affect work or SSDI benefits at this very early period . Conclusions : The results provide rigorous evidence that health care benefits can increase health care use and health outcomes . Longer-term follow-up is needed to fully assess the program ’s effects on its ultimate benefits and costs , including its long-term effects on health , employment , and benefit receipt",
"OBJECTIVES The purpose of this study was to test whether early education intervention influences maternal employment , education , fertility , and receipt of public assistance and health insurance . METHODS The Infant Health and Development Program is a r and omized trial of the efficacy of early education on the outcomes of 985 low-birthweight , premature children . Families in eight sites received either pediatric follow-up and referral ( follow-up only group ) or pediatric services plus early intervention services ( intervention group ) for the first 3 years of the child 's life . RESULTS Mothers in the intervention group were employed more months and returned to the work force earlier than those in the follow-up only group . Fertility and education were not associated with treatment . Mothers who had some college education received more months of public assistance in the intervention group compared with the follow-up only group . Mothers who were employed received more public assistance and public health insurance in the intervention group compared with the follow-up only group , when maternal employment was controlled . CONCLUSIONS Findings are discussed in terms of the recent emphasis on two-generational programs directed to providing health , welfare , and child care services to young children and their families",
"The relationship between depressive symptoms in young adults , the quality of the early home environment , and early educational child care was investigated in young adults r and omly assigned to receive early childhood intervention in the Abecedarian study . Of the original 111 infants enrolled ( 98 % African American ) , 104 participated in an age-21 follow-up . Those who had early treatment reported fewer depressive symptoms . The protective effects of the early childhood program were further supported by a significant home environment by treatment interaction . Negative effects of lower quality home environments on young adult depressive symptoms were almost entirely offset by preschool treatment , whereas depressive symptoms increased as the quality of the early home environment decreased for those in the control group",
"There is a common view among social and public health scientists that there is an evidence -based medicine ( EBM ) juggernaut , a powerful , naive , and overweening attempt to impose an inappropriately narrow and medical model of experimentation onto a complex social world . We have both frequently come across hostility among social scientists , and public health or health promotion practitioners or theorists , to attempts to apply EBM principles ( for example , systematic review s or experimental design s ) in social or public health setting s ( for example , sex education in schools , health promotion campaigns , or community development1 ) . We believe such hostility to be misplaced , and to be based on a number of misconceptions . The first misconception is that systematic review s and experimental design s have a wholly biomedical provenance . As Ann Oakley has pointed out , the use of experimental design s was well established in United States by the 1930s , and from the early 1960s to early 1980s there were many r and omised experiments for evaluating public policy interventions in United States , these being considered the optimum design . Much of the early literature on experimental design s ( including blinding ) came from the social sciences , as a response to the perceived need to be able to make valid causal inferences.2 The second misconception is that the “ real world ” is too complex , messy ,",
"In a retrospective survey , 487 research projects approved by the Central Oxford Research Ethics Committee between 1984 and 1987 , were studied for evidence of publication bias . As of May , 1990 , 285 of the studies had been analysed by the investigators , and 52 % of these had been published . Studies with statistically significant results were more likely to be published than those finding no difference between the study groups ( adjusted odds ratio [ OR ] 2.32 ; 95 % confidence interval [ Cl ] 1.25 - 4.28 ) . Studies with significant results were also more likely to lead to a greater number of publications and presentations and to be published in journals with a high citation impact factor . An increased likelihood of publication was also associated with a high rating by the investigator of the importance of the study results , and with increasing sample size . The tendency towards publication bias was greater with observational and laboratory-based experimental studies ( OR = 3.79 ; 95 % Cl = 1.47 - 9.76 ) than with r and omised clinical trials ( OR = 0.84 ; 95 % Cl = 0.34 - 2.09 ) . We have confirmed the presence of publication bias in a cohort of clinical research studies . These findings suggest that conclusions based only on a review of published data should be interpreted cautiously , especially for observational studies . Improved strategies are needed to identify the results of unpublished as well as published studies",
"CONTEXT Extensive observational evidence indicates that youth in high-poverty neighborhoods exhibit poor mental health , although not all children may be affected similarly . OBJECTIVE To use experimental evidence to assess whether gender and family health problems modify the mental health effects of moving from high- to low-poverty neighborhoods . DESIGN R and omized controlled trial . SETTING Volunteer low-income families in public housing in 5 US cities between 1994 - 1997 . PARTICIPANTS We analyze 4- to 7-year outcomes in youth aged 12 to 19 years ( n = 2829 , 89 % effective response rate ) in the Moving to Opportunity Study . INTERVENTION Families were r and omized to remain in public housing ( control group ) or to receive government-funded rental subsidies to move into private apartments ( experimental group ) . Intention-to-treat analyses included intervention interactions by gender and health vulnerability ( defined as prer and omization health/developmental limitations or disabilities in family members ) . MAIN OUTCOME MEASURES Past-year psychological distress ( Kessler 6 scale [ K6 ] ) and the Behavioral Problems Index ( BPI ) . Supplemental analyses used past-year major depressive disorder ( MDD ) . RESULTS Male gender ( P = .02 ) and family health vulnerability ( P = .002 ) significantly adversely modified the intervention effect on K6 scores ; male gender ( P = .01 ) , but not health vulnerability ( P = .17 ) , significantly adversely modified the intervention effect on the BPI . Girls without baseline health vulnerabilities were the only subgroup to benefit on any outcome ( K6 : β = -0.21 ; 95 % CI , -0.34 to -0.07 ; P = .003 ; MDD : odds ratio = 0.42 ; 95 % CI , 0.20 to 0.85 ; P = .02 ) . For boys with health vulnerabilities , intervention was associated with worse K6 ( β = 0.26 ; 95 % CI , 0.09 to 0.44 ; P = .003 ) and BPI ( β = 0.24 ; 95 % CI , 0.09 to 0.40 ; P = .002 ) values . Neither girls with health vulnerability nor boys without health vulnerability experienced intervention benefits . Adherence-adjusted instrumental variable analysis found intervention effects twice as large . Patterns were similar for MDD , but estimates were imprecise owing to low prevalence . CONCLUSIONS Although some girls benefited , boys and adolescents from families with baseline health problems did not experience mental health benefits from housing mobility policies and may need additional program supports",
"BACKGROUND Despite the imminent expansion of Medicaid coverage for low-income adults , the effects of exp and ing coverage are unclear . The 2008 Medicaid expansion in Oregon based on lottery drawings from a waiting list provided an opportunity to evaluate these effects . METHODS Approximately 2 years after the lottery , we obtained data from 6387 adults who were r and omly selected to be able to apply for Medicaid coverage and 5842 adults who were not selected . Measures included blood-pressure , cholesterol , and glycated hemoglobin levels ; screening for depression ; medication inventories ; and self-reported diagnoses , health status , health care utilization , and out-of-pocket spending for such services . We used the r and om assignment in the lottery to calculate the effect of Medicaid coverage . RESULTS We found no significant effect of Medicaid coverage on the prevalence or diagnosis of hypertension or high cholesterol levels or on the use of medication for these conditions . Medicaid coverage significantly increased the probability of a diagnosis of diabetes and the use of diabetes medication , but we observed no significant effect on average glycated hemoglobin levels or on the percentage of participants with levels of 6.5 % or higher . Medicaid coverage decreased the probability of a positive screening for depression ( -9.15 percentage points ; 95 % confidence interval , -16.70 to -1.60 ; P=0.02 ) , increased the use of many preventive services , and nearly eliminated catastrophic out-of-pocket medical expenditures . CONCLUSIONS This r and omized , controlled study showed that Medicaid coverage generated no significant improvements in measured physical health outcomes in the first 2 years , but it did increase use of health care services , raise rates of diabetes detection and management , lower rates of depression , and reduce financial strain",
"OBJECTIVES We explored whether a successful r and omized controlled trial of early education , the Carolina Abecedarian Project ( ABC ) , which enrolled infants from 1972 to 1977 at the Frank Porter Graham Child Development Institute in Chapel Hill , North Carolina , improved health outcomes and behaviors by 21 years of age . METHODS ABC r and omized 111 infants to receive an intensive early education program or nutritional supplements and parental counseling alone ; participants have been followed to the present day . We examined the effect of ABC on health outcomes and behavioral risk factors when participants were aged 21 years , and then explored the mediators of this relationship . RESULTS Relative to the control group , the ABC treatment group was previously found to have improved cognition and educational attainment . We found that the intervention also improved heath ( P = .05 ) and health behaviors ( P = .03 ) when participants were aged 21 years . These improvements in behaviors were not mediated by IQ , math and reading scores at 15 years of age , educational attainment , or health insurance . CONCLUSIONS Effective early education programs may improve health and reduce risky health behaviors in adulthood"
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Background and Objectives : The aim of this systematic review was to examine the effect of 2 % chlorhexidine following acid etching on the microtensile bond strength of resin restorations for different follow-up times . Material s and Methods : A thorough search of PubMed , Scopus , and Embase data bases were conducted . In vitro experimental studies or in vivo studies published up to December 2018 with an experimental group treated with a 2 % chlorhexidine solution following acid etching and a control group were included , wherein the final restoration used a resin composite in both the groups . Results : Twenty-one articles were identified for qualitative analysis and 18 for meta- analysis . The difference in the means of microtensile bond strength between the two groups was calculated for the different follow-up times . The differences were significant for 6 months ( 4.30 MPa ; 95 % CI 2.72 - 5.89 ) , 12 months ( 8.41 MPa ; 95 % CI 4.93 - 11.88 ) , and 2 - 5 years including aged and thermocycling sample s ( 9.08 MPa ; 95 % CI 5.36 - 12.81 ) . There were no significant differences for the type of adhesive used . A meta-regression model showed a significant effect of time on the microtensile bond strength . Conclusions : The application of a 2 % chlorhexidine solution after acid etching increased the microtensile bond strength significantly for follow-up times of 6 months or more . The adhesive type had no influence
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"This study evaluated the effect of 2 % chlorhexidine ( CHX ) pretreatment of dentin on the immediate and aged microtensile bond strength ( μTBS ) of different adhesives to dentin in vivo and in vitro . Class I cavities were prepared in 80 caries-free human third molars of 40 patients in a split-mouth fashion . In each tooth pair , one tooth received 2 % CHX pretreatment after which both teeth were r and omly assigned to one of the following groups with respect to the type of adhesive system applied : Adper Single Bond 2 ( etch- and -rinse ) , Clearfil SE Bond ( two-step self-etch ) , Clearfil S(3 ) Bond ( one-step self-etch ) , and Adper Prompt-L-Pop ( all-in-one self-etch ) . The teeth were restored with resin composite and extracted for μTBS testing either immediately or after six months in function . In vitro specimen pairs were prepared as with the clinical protocol in intact , freshly extracted human molars , and thereafter , subjected to testing immediately or after 5000 × thermocycling . Data were analyzed with four-way analysis of variance ( ANOVA ) . Bonferroni test was utilized for pair-wise comparisons . The immediate bond strength values were significantly higher than \" aged \" ones for all tested adhesives ( p=0.00 ) . The in vitro immediate bond strength values were statistically higher than in vivo bond strength values ( p the bond strength of in vitro aged , CHX-treated sample s were higher than their in vivo counterparts ( p0.05 ) . In the absence of CHX pretreatment , all adhesives showed significantly higher immediate bond strength values than CHX-treated groups , while all \" aged \" , non-pretreated adhesives exhibited significantly lower bond strength values ( both p contrast , chlorhexidine pretreatment result ed in significantly higher aged bond strengths , regardless of the adhesive system and testing condition . Aging-associated decline in dentin bond strength of etch- and rinse and self-etch adhesives can be counteracted by chlorhexidine application",
"The purpose of this study was to investigate the influence of chlorhexidine ( CHX ) concentration on the microtensile bond strength ( muTBS ) of contemporary adhesive systems . Eighty bovine central incisors were used in this study . The facial enamel surface of the crowns was abraded with 600-grit silicon carbide paper to expose flat , mid-coronal dentin surfaces . The tested material s were Scotchbond Multi purpose ( SMP ) , Single-Bond ( SB ) , Clearfil SE Bond ( CSEB ) and Clearfil Tri S Bond ( CTSB ) . All the material s were applied according to manufacturer 's instructions and followed by composite application ( Z250 ) . The teeth were r and omly divided into 16 groups : for the etch- and -rinse adhesives ( SMP and SB ) , 0.12 % or 2 % CHX was applied prior to or after the acid etching procedure . For the self-etch adhesives ( CSEB and CTSB ) 0.12 % or 2 % CHX was applied prior to the primer . Control groups for each one of the adhesive systems were also set up . The specimens were immediately su bmi tted to muTBS testing and the data were analyzed using Analysis of Variance and the Tukey post hoc test ( alpha = .01 ) . The failure patterns of the specimens were observed using scanning electron microscopy . The effects of 2 % CHX were statistically significant ( p CHX-based cavity disinfectants in concentrations higher than 0.12 % should be avoided prior to the self-etch adhesive systems evaluated in this study to diminish the possibilities of reduction in bond strength",
"PURPOSE To evaluate the effect of 2 % chlorhexidine on the microtensile bond strength of composite resin to dentin treated with three dentin bonding systems . MATERIAL S AND METHODS Flat dentinal surfaces were prepared in 24 extracted human third molars . Teeth were r and omly divided into 8 distinct experimental groups according to the adhesive applied ( Prime & Bond NT , Single Bond and Clearfil SE Bond ) , the application ( yes/no ) of chlorhexidine , and the time point at which it was applied ( before or after acid etching the dentin ) . Composite resin blocks were built up over treated surfaces , and teeth were then stored in water at 37 degrees C for 24 h. Sample s were thermocycled , stored under the same conditions , and then vertically sectioned , thus obtaining specimens with 1.0 + /- 0.1 mm2 cross-sectional area . Specimens were stressed in tension at 0.5 mm/min crosshead speed . Bond strength results were evaluated using a one-way ANOVA ( p failures were verified using optical microscopy . Dentin disks were obtained from 3 additional teeth treated in the same manner for observation under SEM . The most representative sample s of fractured specimens were also observed under SEM . RESULTS No statistically significant differences of bond strength values were found between any groups . Failures occurred mainly within the bond ; exclusively adhesive fractures ( adhesive-dentin ) were not observed . CONCLUSION The 2 % chlorhexidine solution , applied before or after acid etching of the dentin , did not interfere with the microtensile bond strength of composite resin to the dentin treated with Prime & Bond NT , Single Bond , or Clearfil SE Bond bonding systems",
"Incompletely infiltrated collagen fibrils in acid-etched dentin are susceptible to degradation . We hypothesize that degradation can occur in the absence of bacteria . Partially demineralized collagen matrices ( DCMs ) prepared from human dentin were stored in artificial saliva . Control specimens were stored in artificial saliva containing proteolytic enzyme inhibitors , or pure mineral oil . We retrieved them at 24 hrs , 90 and 250 days to examine the extent of degradation of DCM . In the 24-hour experimental and 90- and 250-day control specimens , we observed 5- to 6-μm-thick layers of DCM containing b and ed collagen fibrils . DCMs were almost completely destroyed in the 250-day experimental specimens , but not when incubated with enzyme inhibitors or mineral oil . Functional enzyme analysis of dentin powder revealed low levels of collagenolytic activity that was inhibited by protease inhibitors or 0.2 % chlorhexidine . We hypothesize that collagen degradation occurred over time , via host-derived matrix metalloproteinases that are released slowly over time",
"Dentine rods measuring approx . 0.7 x 0.7 x 5.0 mm were prepared from the crowns of extracted human third molars . The specimens were demineralized in 0.5 M EDTA ( pH 7.0 ) for 3 days and their volume measured with a digital micrometer under a dissecting microscope . The specimens were r and omly assigned to experimental groups and were chemically dehydrated in acetone . Next they were dried using either hexamethyldisilazane , Peldri II , or critical-point drying techniques . The dimensions of the specimens were measured again after each step and the changes in volume were expressed as a percentage of the original demineralized volume . The effects of fixing the specimens in 10 % buffered formalin before dehydration with acetone were also investigated for every drying procedure . Dehydration in acetone caused a small but significant reduction in the volume of demineralized formalin-fixed specimens but unfixed specimens did not change significantly . In general , all three drying procedures caused some shrinkage in demineralized dentine specimens . Unfixed specimens exhibited a volumetric shrinkage of approx . 15 - 20 % after drying with any of the methods . Fixed specimens shrank more than unfixed specimens after drying ( 25 - 35 % ) . Regardless of the drying technique , the specimens shrank a further 10 - 20 % when measured in the vacuum chamber of the scanning electron microscope . Among the three drying techniques employed , hexamethyldisilazane seems to be a very useful alternative to critical-point drying for the preparation of dentine specimens for scanning electron microscopy",
"OBJECTIVES To examine the effect of adjunctive application of chlorhexidine ( CHX ) and ethanol-wet bonding ( EWB ) on bond durability and nanoleakage of hydrophobic adhesive to sound ( SD ) and caries-affected dentine ( CAD ) . METHODS Dentine surfaces of molars were etched after caries removal and r and omly allocated to four groups ( n=12 ) . In Groups 1 and 2 , dentine surfaces were saturated with either 2 ml of 100 % ethanol or 2 ml of ethanol with 2 % CHX for 60s . In Groups 3 and 4 , dentine surfaces were saturated with either 15 μL of distilled water or 15 μL of distilled water with 2 % CHX for 60s . Two coats of primer , followed by neat resin were applied and light-cured for 40s . Resin composite build-ups were placed and bonded specimens were sectioned for bond strength testing after 24 h and 12 months ' storage in artificial saliva . Bond strength data were analyzed using 3-way ANOVA and SNK tests . Interfacial nanoleakage was evaluated after 24 h and 12 months using a field-emission scanning electron microscopy and data were analyzed using Kruskal-Wallis test . RESULTS Significant differences were observed for the three factors : \" substrate \" ( p \" rewetting agents \" ( p and \" time \" ( p on bond strength . Incorporation of 2 % CHX to EWB preserved bond strength to SD and CAD and reduced interfacial nanoleakage after 12 months . Incorporation of 2 % CHX to WWB also preserved bond strength to SD after ageing . CONCLUSIONS Incorporation of chlorhexidine to ethanol-wet bonding has an interaction effect on preservation of bond durability to sound and caries-affected dentine . CLINICAL SIGNIFICANCE Incorporation of chlorhexidine to ethanol-wet bonding with hydrophobic adhesive enhances the success rate of aesthetic bonded restorations",
"Background The effect of chlorhexidine on bond durability of universal adhesives is not clear . The aim of this study was to evaluate the effect of chlorhexidine on 6-month water storage bond strength of adhesive systems . Material and Methods 72 freshly sound human extracted molars were selected . In each tooth both buccal and lingual sides were prepared by bur to reach superficial dentin and r and omly divided into 6 groups and 12 sub-groups and bonded with Scotchbond Universal ( SBU ) or Scotchbond Multi- purpose ( SBMP ) with/without chlorhexidine ( CHX ) usage . Group 1 : SBU , group2 : SBU+CHX , group3 : Etch+SBU , group4 : Etch+CHX+SBU , group5 : Etch+SBMP , group6 : Etch+CHX+SBMP . After composite curing , water storage and thermocycling was done . Each group was divided into two subgroups . One was tested immediately , and the other was thermocycled for 5000 cycles ( 5 - 55 ° C ) ( it was equivalent to 6 months of storage in distilled water ) . Shear bond strength test was done and failure modes were determined by Stereomicroscope . The data were analyzed by one-way ANOVA , Tukey post-hoc test and Paired Two test with P Results Shear bond strength in late SBU ( Self etch ) was significantly lower than late SBU [ Etch and rinse ( ER ) ] , P value= 0.0001 , also shear bond strength in late SBU [ self-etch ( SE ) ] was significantly lower than immediate SBU ( SE ) , P value= 0.01 . There were no significant differences between other sub-groups and conditions . The most failure mode was adhesive in all the groups . Conclusions Long term bonding durability of SBU(ER ) was better than SBU ( SE ) . CHX usage had prevented bond strength decrease in SBU and SBMP in long term . CHX usage did not have any effect on immediate shear bond strength of SBU and SBMP . Immediate and late shear bond strength of SBMP with/without CHX usage was similar to SBU(SE , ER ) . Key words : Dentin Bonding , Shear Bond Strength , chlorhexidine , 6-month storage",
"STATEMENT OF THE PROBLEM With Institutional Review Board approval , 39 patients who needed restoration of noncarious cervical lesions ( NCCLs ) were enrolled in this study . A total of 125 NCCLs were selected and r and omly assigned to four groups : 1 ) a three-step etch- and -rinse adhesive , Adper Scotchbond Multi- Purpose ( MP , 3 M ESPE , St Paul , MN , USA ) ; 2 ) a two-step etch- and -rinse adhesive , Adper Single Bond Plus ( SB , 3 M ESPE ) ; 3 ) a two-step self-etch adhesive , Adper Scotchbond SE ( SE , 3 M ESPE ) ; and 4 ) a one-step self-etch adhesive , Adper Easy Bond ( EB , 3 M ESPE ) . A nanofilled composite resin was used for all restorations . Restorations were evaluated at six months and 18 months using modified U.S. Public Health Service ( USPHS ) parameters . RESULTS At six months after initial placement , 107 restorations ( 85.6 % recall rate ) were evaluated . At 18 months , 94 restorations ( 75.2 % recall rate ) were available for evaluation . The 6 mo/18 mo overall retention rates ( % ) were 100/90.9 for MP ; 100/91.7 for SB ; 100/90.9 for SE ; and 96.4/92.3 for EB with no statistical difference between any pair of groups at each recall . Sensitivity to air decreased significantly for all adhesives from the preoperative to the postoperative stage and was stable thereafter . Interfacial staining did not change statistically from baseline to six months ; however , interfacial staining at the enamel margins was statistically worse at 18 months than at baseline for the two self-etch adhesives EB and SE . Marginal adaptation was statistically worse at 18 months compared with baseline only for EB . This tendency was already significant at the six-month recall . CONCLUSION Although 18-month retention was similar for the different adhesion strategies , enamel marginal deficiencies were more prevalent for the self-etch adhesives"
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41174560-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Intermittent claudication ( IC ) is a common and debilitating symptom of peripheral arterial disease and is associated with a significant reduction in a sufferer 's quality of life . Guidelines recommend a supervised exercise program ( SEP ) as the primary treatment option ; however , anecdotally there is a low participation rate for exercise in this group of patients . We undertook a systematic review of the uptake and adherence rates to SEPs for individuals with IC . METHODS The MEDLINE , Embase , and PubMed data bases were search ed up to January 2015 for terms related to supervised exercise in peripheral arterial disease . The review had 3 aims : first , to establish the rates of uptake to SEPs , second , the rates of adherence to programs , and finally to determine the reasons reported for poor uptake and adherence . Separate inclusion and /or exclusion criteria were applied in selecting reports for each aim of the review . RESULTS Only 23 of the 53 potentially eligible articles for uptake analysis identified on literature search es reported any details of screened patients ( n = 7,517 ) with only 24.2 % of patients subsequently recruited to SEPs . Forty-five percent of screen failures had no reason for exclusion reported . Sixty-seven articles with 4,012 patients were included for analysis of SEP adherence . Overall , 75.1 % of patients reportedly completed an SEP ; however , only one article defined a minimal attendance required for SEP completion . Overall , 54.1 % of incomplete adherence was due to patient withdrawal and no reason for incomplete adherence was reported for 16 % of cases . CONCLUSIONS Reporting of SEP trials was poor with regard to the numbers of subjects screened and reasons for exclusions . Only approximately 1 in 3 screened IC patients was suitable for and willing to undertake SEP . Levels of adherence to SEPs and definitions of satisfactory adherence were also lacking in most the current literature . Current clinical guidelines based on this evidence base may not be applicable to most IC patients and changes to SEPs may be needed to encourage and /or retain participants
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"BACKGROUND This prospect i ve , r and omized controlled clinical trial determined whether an optimal exercise program length exists to efficaciously change claudication onset time ( COT ) and peak walking time ( PWT ) in patients with peripheral artery disease and claudication . METHODS The study r and omized 142 patients to supervised exercise ( n = 106 ) or a usual care control group ( n = 36 ) , with 80 completing the exercise program and 27 completing the control intervention . The exercise program consisted of intermittent walking to nearly maximal claudication pain 3 days per week . COT and PWT were the primary outcomes obtained from a treadmill exercise test at baseline and bimonthly during the study . RESULTS After exercise , changes in COT ( P PWT ( P exercise program , COT and PWT increased from baseline to month 2 ( P .05 ) . When changes were expressed per mile walked during the first 2 months , middle 2 months , and final 2 months of exercise , COT and PWT only increased during the first 2 months ( P gains in COT and PWT occur rapidly within the first 2 months of exercise rehabilitation and are maintained with further training . The clinical significance is that a relatively short 2-month exercise program may be preferred to a longer program to treat claudication because adherence is higher , costs associated with personnel and use of facilities are lower per patient , and more patients can be trained for a given amount of personnel time and re source utilization",
"BACKGROUND In patients with intermittent claudication , a supervised walking exercise program increases peak exercise performance and community-based functional status . Patients with peripheral arterial disease also have muscle weakness in the affected extremity that may contribute to the walking impairment . However , the potential benefits of training modalities other than walking exercise , such as strength training , have not been critically evaluated in this patient population . The present study tested the hypothesis that a strength training program would be as effective as treadmill walking exercise and that combinations of strengthening and walking exercise would be more effective than either alone in improving exercise performance . METHODS AND RESULTS Twenty-nine patients with disabling claudication were r and omized to 12 weeks of supervised walking exercise on a treadmill ( 3 h/wk at a work intensity sufficient to produce claudication ) , strength training ( 3 h/wk of resistive training of five muscle groups of each leg ) , or a nonexercising control group . Grade d treadmill testing was performed to maximally tolerated claudication pain to define changes in peak exercise performance . After 12 weeks , patients in the treadmill training program had a 74 + /- 58 % increase in peak walking time as well as improvements in peak oxygen consumption ( VO2 ) and the onset of claudication pain . Patients in the strength-trained group had a 36 + /- 48 % increase in peak walking time but no change in peak VO2 or claudication onset time . Control subjects had no changes in any of these measures over the 12-week period . After the first 12 weeks , patients in the initial walking exercise group continued for 12 more weeks of supervised treadmill training . This result ed in an additional 49 + /- 53 % increase in peak walking time ( total of 128 + /- 99 % increase over the 24 weeks ) . After the initial 12 weeks , patients in the strength-trained group began 12 weeks of supervised treadmill training , and patients in the control group participated in a 12-week combined program of strengthening and treadmill walking exercise . The combined strength and treadmill training program and treadmill training after 12 weeks of strength training result ed in increases in peak exercise performance similar to those observed with 12 weeks of treadmill training alone . CONCLUSIONS A supervised treadmill walking exercise program is an effective means to improve exercise performance in patients with intermittent claudication , with continued improvement over 24 weeks of training . In contrast , 12 weeks of strength training was less effective than 12 weeks of supervised treadmill walking exercise . Finally , strength training , whether sequential or concomitant , did not augment the response to a walking exercise program",
"Patients with atherosclerotic peripheral arterial disease ( PAD ) of the lower extremities have impaired walking ability due to exercise-induced muscle ischemia and the result ant pain of intermittent claudication . To evaluate the benefit of exercise training as a treatment for patients with PAD , as well as possible mechanisms associated with improvement , we r and omly assigned 19 men with disabling claudication to treated and control groups . Treatment consisted of supervised treadmill walking ( 1 hr/day , 3 days/wk , for 12 weeks ) with progressive increases in speed and grade as tolerated . Grade d treadmill testing was performed to maximal toleration of claudication pain on entry and after 12 weeks of training to define changes in peak exercise performance . After 12 weeks , treated subjects had increased their peak walking time 123 % , peak oxygen consumption 30 % , and pain-free walking time 165 % ( all p less than 0.05 ) . Control subjects had no change in peak oxygen consumption , but after 12 weeks , peak walking time increased 20 % ( p less than 0.05 ) . In treated subjects , maximal calf blood flow ( measured by a plethysmograph ) increased 38 + /- 45 % ( p less than 0.05 ) , but the change in flow was not correlated to the increase in peak walking time . Elevated plasma concentrations of acylcarnitines have been associated with the functional impairment of PAD and may reflect the metabolic state of ischemic skeletal muscle . In treated subjects , a 26 % decrease in resting plasma short-chain acylcarnitine concentration was correlated with improvement in peak walking time ( r = -0.78 , p less than 0.05 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE Exercise advice is the main treatment for symptom relief in the UK for patients with mild to moderate Intermittent Claudication ( IC ) . Would a weekly exercise and motivation class for 6 months offer adjuvant benefit over written and verbal exercise advice alone ? PATIENTS AND METHODS Fifty-nine patients attending a regional vascular centre for whom IC was the main factor affecting mobility were r and omised to either exercise advice alone ( n=30 ) or exercise advice with a once a week 45 min supervised exercise/motivation class ( n=29 ) . The mean age was 68 years . Baseline and 6-month assessment included a Quality of Life Question naire -- the Short-Form-36 , the Charing Cross Symptom Specific Claudication Question naire ( CCCQ ) and treadmill walking distance ( 3.5 km/h 12 % ) . RESULTS At 6-month follow-up the supervised exercise group had improved their treadmill walking by 129 % compared to 69 % in the advice alone group ( p=0.001 ) . This significant improvement was maintained at the subsequent 9 and 12-month follow-up assessment s. By the 9-month stage the advice only group CCCQ score had improved 16 % from baseline , while the supervised exercise group had a significantly better 43 % improvement in base line score ( p Self reported frequency of walks was higher in the exercise class group being significant for improvement in CCCQ score . CONCLUSION A weekly , supervised exercise and motivation class for a 6-month period provides a significant improvement in patients ' symptoms , quality of life , and distance walked compared with advice alone and this improvement continues after attendance at class has ceased",
"The aim of this study was to explore the effects during 12 months follow-up of 12 weeks of supervised exercise therapy ( SET ) after percutaneous transluminal angioplasty ( PTA ) compared to PTA alone on physical function , limb hemodynamics and health-related quality of life ( HRQoL ) in patients with intermittent claudication . Fifty patients were r and omised to an intervention or a control group . Both groups received usual post-operative care and follow-up measurements at three , six and 12 months after PTA . The intervention group performed 12 weeks of SET after PTA . The control group did not receive any additional follow-up regarding exercise . During the 12 months ’ follow-up , the members of the intervention group had significantly better walking distance than the control group . The intervention group had a significantly higher HRQoL score in the physical component score of the SF-36 , and the domains of physical function , bodily pain and vitality . For limb hemodynamics , there was a non-significant trend towards better results in the intervention group compared to the control group . Conclusion : SET after PTA yielded statistically significantly better results for walking distance and HRQoL in the intervention group than the control group during the 12 months of follow-up",
"Objective —Peripheral artery disease ( PAD ) is characterized by impaired blood flow to the lower extremities , causing claudication and exercise intolerance . The mechanism(s ) by which exercise training improves functional capacity is not understood . This study tested the hypothesis that in PAD patients who undergo supervised exercise training , increases in capillary density ( CD ) in calf muscle take place before improvements in peak oxygen uptake ( VO2 ) . Methods and Results —Thirty-five PAD patients were r and omly assigned to 12 weeks of directly supervised or home-based exercise training . Peak VO2 testing and gastrocnemius muscle biopsies were performed at baseline and after training . CD ( endothelial cells/mm2 ) was measured using immunofluorescence staining . After 3 weeks of directly supervised training , patients had an increase in CD ( 216±66 versus 284±77 , P increase in peak VO2 . However , after 12 weeks , peak VO2 increased ( 15.3±2.8 versus 16.8±3.8 , P CD remained increased over baseline , but there were no changes in markers of oxidative capacity . Within subjects , CD was related to peak VO2 before and after directly supervised training . Conclusion —Changes in CD in ischemic muscle with training may modulate the response to training , and those changes precede the increase in VO2",
"PURPOSE : The purpose of this study was to compare the effects of a 24-week walking with poles rehabilitation program with a traditional 24-week walking program on physical function in patients with peripheral arterial disease ( PAD ) . METHODS : Patients with PAD ( n = 103 , age = 69.7 ± 8.9 years , ankle-brachial index were r and omized into a rehabilitation program of traditional walking ( n = 52 ) or walking with poles ( n = 51 ) . Patients exercised 3 times per week for 24 weeks . Exercise endurance was measured by time walked on a constant work rate treadmill test at 6 , 12 , and 24 weeks . Perceived physical function was measured by the Medical Outcomes Study Short Form-36 and Walking Impairment Question naire . Tissue oxygenation was measured using near-infrared spectroscopy . RESULTS : Patients assigned to the traditional walking group walked longer at 24 weeks than those assigned to the pole walking group ( 21.10 ± 17.07 minutes and 15.02 ± 12.32 minutes , respectively , P = .037 ) . There were no differences between the groups in tissue oxygenation . However , there was a significant lengthening of time for which it took to reach minimum tissue oxygenation values ( P in perceived physical function as measured by the Physical Function subscale on the Medical Outcomes Study Short Form-36 or perceived walking distance as measured by the Walking Distance subscale on the Walking Impairment Scale . CONCLUSIONS : Traditional walking was superior to walking with poles in increasing walking endurance on a constant work rate treadmill test for patients with PAD",
"PURPOSE The effects of upper-limb ( arm cranking ) and lower-limb ( leg cranking ) exercise training on walking distances in patients with intermittent claudication was assessed . METHODS Sixty-seven patients ( 33 to 82 years old ) with moderate to severe intermittent claudication were recruited , and the maximum power generated during incremental upper- and lower-limb ergometry tests was determined , as were pain-free and maximum walking distances ( by using a shuttle walk test ) . Patients were r and omly assigned to an upper-limb training group ( n = 26 ) or a lower-limb training group ( n = 26 ) . An additional untrained group ( n = 15 ) was recruited on an ad hoc basis in parallel with the main trial by using identical inclusion criteria . This group was subsequently shown to possess a similar demographic distribution to the two exercise groups . Supervised training sessions were held twice weekly for 6 weeks . RESULTS Both training programs significantly improved the maximum power generated during the incremental upper- and lower-limb ergometry tests ( P central cardiovascular function that was independent of the training mode . More importantly , pain-free and maximum walking distances also improved in both training groups ( P upper-limb exercise training may result , in part , from systemic cardiovascular effects rather than localized metabolic or hemodynamic changes . CONCLUSION Carefully prescribed upper-limb exercise training can evoke a rapid symptomatic improvement in patients with claudication , while avoiding the physical discomfort experienced when performing lower-limb weight-bearing exercise",
"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 ",
"OBJECTIVES The main aims of treatment in patients with intermittent claudication ( IC ) are to improve the clinical indicators of lower limb ischaemia and patients ' quality of life ( QoL ) . The aims of this study were assess the clinical and cost effectiveness of a supervised exercise programme ( SEP ) in patients with IC . DESIGN Non-r and omised , controlled trial . SETTING University teaching hospital . PATIENTS AND METHODS Two groups of patients with IC were studied . Seventy patients were sequentially recruited before and after the establishment of a Supervised Exercise Programme at our unit . Thirty-seven patients ( median age 69 years , 26 men ) received conservative medical therapy ( CMT ) and 33 patients ( median age 67 years , 22 men ) received CMT plus a 3 month SEP of graduated physical exercise for sixty minutes , three times each week . Patients were assessed prior to and at 6 months following treatment . At each assessment patient reported walking distances ( PRWD ) , treadmill claudication and maximal distances ( ICD and MWD ) , ankle brachial pressure indices ( ABPI ) pre & post exercise and patient reported QoL using the SF36 question naire were assessed . RESULTS Prior to intervention the two groups were well matched . Following treatment , CMT patients demonstrated no significant change in PRWD or ICD but did record a small but significant improvement in MWD . CMT was also associated with a negative effect size in the SF36 index and in 7 of the 8 SF36 QoL domains , effect size > -0.5 for the domains of Physical Function and Emotional Role . SEP patients demonstrated significant improvement in PRWD , ICD and MWD . SEP was associated with a positive effect size in the SF36 index and in 2 SF36 QoL domains but a negative effect size in a further 2 domains . However , all QoL effect sizes following SEP were 0.5 for the SF36 domains of Physical Function , Physical Role , Emotion Role and SF36 index . SEP result ed in a 0.027 quality adjusted life year ( QALY ) gain over CMT in the first year post-treatment thus the cost/QALY gained of SEP is pound1780 at 1 year . CONCLUSIONS Compared to CMT , SEP increases walking distances , improves QoL and is a highly cost-effective treatment for IC",
"PURPOSE To determine if improvements in physical function and peripheral circulation after 6 months of exercise rehabilitation could be sustained over a subsequent 12-month maintenance exercise program in older patients with intermittent claudication . METHODS Seventeen patients r and omized to exercise rehabilitation and 14 patients r and omized to usual care control completed this 18-month study . Patients exercised three times per week during the first 6 months of a progressive exercise program , followed by two times per week during the final 12 months of a maintenance program . Patients were studied at baseline , 6 months , and 18 months during the study . RESULTS Eighteen months of exercise rehabilitation increased the initial claudication distance by 373 meters ( 189 % ) ( P absolute claudication distance by 358 meters ( 80 % ) ( P walking economy by 11 % ( P 6-minute walk distance by 10 % ( P daily physical activity by 31 % , and maximal calf blood flow by 18 % ( P exercise rehabilitation ( P = NS ) , and were significantly greater than the changes in the control group throughout the study ( P Improvements in claudication distances , walking economy , 6-minute walk distance , physical activity level , and peripheral circulation after 6 months of exercise rehabilitation are sustained for an additional 12 months in older patients with intermittent claudication using a less frequent exercise maintenance program",
"AIMS To determine if type 2 diabetes mellitus ( T2D ) differentiates endothelial function and plasma nitrite response ( a marker of nitric oxide bioavailability ) during exercise in peripheral arterial disease ( PAD ) subjects prior to and following 3 months supervised exercise training ( SET ) . METHODS In subjects with T2D+PAD ( n = 13 ) and PAD-only ( n = 14 ) , endothelial function was measured using brachial artery flow-mediated dilation . On a separate day , venous blood draws were performed at rest and 10 min following a symptom-limited grade d treadmill test ( SL-GXT ) . Plasma sample s were snap-frozen for analysis of nitrite by reductive chemiluminescence . All testing was repeated following 3 months of SET . RESULTS Prior to training both groups demonstrated endothelial dysfunction , which was correlated with a net decrease in plasma nitrite following a SL-GXT ( p ≤ 0.05 ) . Following SET , the PAD-only group demonstrated an improvement in endothelial function ( p ≤ 0.05 ) and COT ( p ≤ 0.05 ) , which was related to a net increase in plasma nitrite following the SL-GXT ( both p ≤ 0.05 ) . The T2D+PAD group had none of these increases . CONCLUSIONS T2D in the presence of PAD attenuated improvements in endothelial function , net plasma nitrite , and COT following SET . This suggests that T2D maybe associated with an inability to endogenously increase vascular NO bioavailability to SET",
"OBJECTIVE To examine the influence of peripheral arterial disease ( PAD ) on heart rate variability ( HRV ) in patients , and to examine the influence of an intense long-term ( 12 months ) exercise program on HRV in PAD patients . METHODS This study involved ambulatory patients attending a local hospital and university center . Participants were twenty-five patients with diagnosed PAD and intermittent claudication and 24 healthy , age-matched adults . Interventions involved r and om allocation of PAD patients to 12 months of conservative medical treatment ( Conservative ) or medical treatment with supervised treadmill walking ( Exercise ) . The main outcome measures were time- and frequency-domain , nonlinear HRV measures during supine rest , and maximal walking capacity prior to and following the intervention . RESULTS Despite significantly worse walking capacity ( 285 ± 190 m vs 941 ± 336 m ; P , Exercise patients exhibited a significantly greater improvement in walking capacity ( 183 % ± 185 % vs 57 % ± 135 % ; P = .03 ) with similar small nonsignificant changes in HRV compared with Conservative patients . CONCLUSIONS The current study demonstrated that PAD patients exhibited similar resting HRV to healthy adults with 12 months of intense supervised walking producing similar HRV changes to that of conservative medical treatment . The greater walking capacity of healthy adults and PAD patients following supervised exercise does not appear to be associated with enhanced HRV",
"PURPOSE The purpose of this r and omized trial was to compare the efficacy of a low-intensity exercise rehabilitation program vs a high-intensity program in changing physical function , peripheral circulation , and health-related quality of life in peripheral arterial disease ( PAD ) patients limited by intermittent claudication . METHODS Thirty-one patients r and omized to low-intensity exercise rehabilitation and 33 patients r and omized to high-intensity exercise rehabilitation completed the study . The 6-month exercise rehabilitation programs consisted of intermittent treadmill walking to near maximal claudication pain 3 days per week at either 40 % ( low-intensity group ) or 80 % ( high-intensity group ) of maximal exercise capacity . Total work performed in the two training regimens was similar by having the patients in the low-intensity group exercise for a longer duration than patients in the high-intensity group . Measurements of physical function , peripheral circulation , and health-related quality of life were obtained on each patient before and after the rehabilitation programs . RESULTS After the exercise rehabilitation programs , patients in the two groups had similar improvements in these measures . Initial claudication distance increased by 109 % in the low-intensity group ( P absolute claudication distance increased by 61 % ( P peak oxygen uptake , ischemic window , and health-related quality of life . CONCLUSION The efficacy of low-intensity exercise rehabilitation is similar to high-intensity rehabilitation in improving markers of functional independence in PAD patients limited by intermittent claudication , provided that a few additional minutes of walking is accomplished to elicit a similar volume of exercise",
"BACKGROUND The prothrombotic , hypofibrinolytic state that develops in patients with intermittent claudication ( IC ) upon walking due to ischemia-reperfusion injury ( IRI ) of the leg muscles may contribute to the high incidence of life- and limb-threatening thrombotic events observed in this patient group . Treatments , such as angioplasty , that obtund the IRI also ameliorate the procoagulant diathesis . The effect on this diathesis of supervised exercise and cilostazol , both of which provide symptomatic benefit in IC , but without significantly obtunding IRI , is unknown . METHODS Thirty-four patients ( 27 men and 7 women ; median age , 67 years ; range , 63 - 72 years ) were r and omized to receive best medical therapy ( BMT ) plus supervised exercise ( n = 9 ) , BMT plus cilostazol ( n = 9 ) , BMT plus supervised exercise plus cilostazol ( n = 7 ) , or BMT alone ( n = 9 ) in a 2 x 2 factorial design . Thrombin-antithrombin complex and prothrombin fragments 1 and 2 , both markers of thrombin generation ; plasminogen activator inhibitor antigen and tissue plasminogen activator antigen , both markers of fibrinolysis ; ankle-brachial pressure index ( ABPI ) ; and initial and absolute claudication distance ( ACD ) were measured at baseline and then 3 and 6 months after r and omization . RESULTS At 6 months , when compared with receiving BMT only , supervised exercise and cilostazol result ed in improvements in ABPI of 18 % and 13 % and in ACD of 40 % and 64 % , respectively . The effects on ABPI and ACD of combining supervised exercise and cilostazol were additive . Supervised exercise , cilostazol , and supervised exercise combined with cilostazol had no significant effect on any of the four hemostatic markers . CONCLUSIONS Treatment of IC by supervised exercise or cilostazol results in significant improvements in ABPI and ACD but has no demonstrable effect on the prothrombotic diathesis . This suggests that supervised exercise and cilostazol , unlike angioplasty , are unlikely to have a long-term beneficial effect on the thrombotic risks faced by these patients",
"PURPOSE To compare clinical success , functional capacity , and quality of life during 12 months after revascularization or supervised exercise training in patients with intermittent claudication . MATERIAL S AND METHODS This study had institutional review board approval , and all patients gave written informed consent . Between September 2002 and September 2005 , 151 consecutive patients who presented with symptoms of intermittent claudication were r and omly assigned to undergo either endovascular revascularization ( angioplasty-first approach ) ( n = 76 ) or hospital-based supervised exercise ( n = 75 ) . The outcome measures were clinical success , functional capacity , and quality of life after 6 and 12 months . Clinical success was defined as improvement in at least one category in the Rutherford scale above the pretreatment level . Significance of differences between the groups was assessed with the unpaired t test , chi(2 ) test , or Mann-Whitney U test . To adjust outcomes for imbalances of baseline values , multivariable regression analysis was performed . RESULTS Immediately after the start of treatment , patients who underwent revascularization improved more than patients who performed exercise in terms of clinical success ( adjusted odds ratio [ OR ] , 39 ; 99 % confidence interval [ CI ] : 11 , 131 ; P signs of ipsilateral symptoms at 6 months compared with patients in the exercise group ( adjusted OR , 0.4 ; 99 % CI : 0.2 , 0.9 ; P functional capacity and quality of life scores increased after 6 and 12 months , but no significant differences between the groups were demonstrated . CONCLUSION After 6 and 12 months , patients with intermittent claudication benefited equally from either endovascular revascularization or supervised exercise . Improvement was , however , more immediate after revascularization",
"OBJECTIVES To compare the effect of unsupervised exercise , supervised exercise and intermittent pneumatic foot and calf compression ( IPC ) on the claudication distance , lower limb arterial haemodynamics and quality of life of patients with intermittent claudication . METHODS Thirty-four eligible patients with stable intermittent claudication were r and omised to IPC ( n = 13 , 3h/d for 6 months ) , supervised exercise ( n = 12 , three hourly sessions/week for 6 months ) or unsupervised exercise ( n = 9 ) . In each patient , initial claudication distance ( ICD ) , absolute claudication distance ( ACD ) , resting ankle brachial pressure index ( ABPI ) , and resting hyperaemic calf arterial inflow were measured before , 6 weeks , 6 months and 1 year after r and omisation . Quality of life was assessed with the short form (SF)-36 , walking impairment ( WIQ ) and intermittent claudication question naires ( ICQ ) . RESULTS Compared with unsupervised exercise , both IPC and supervised exercise , increased ICD and ACD , up to 2.83 times . IPC increased arterial inflow ( p ABPI . Supervised exercise decreased arterial inflow and increased ABPI ( p Unsupervised exercise had no effect on arterial inflow or ABPI . IPC improved significantly the ICQ score and the speed score of the WIQ , while supervised exercise improved the WIQ claudication severity score . At 1 year clinical effectiveness of supervised exercise and IPC was largely preserved . CONCLUSIONS IPC , by augmenting leg perfusion , achieved improvement in walking distance comparable with supervised exercise . Long-term results in a larger number of patients will provide valuable information on the optimal treatment modality of intermittent claudication",
"In a non-r and omized , open-label study results after a structured institution-based peripheral arterial occlusive disease ( PAD ) rehabilitation program were compared with the results of training at home . Three groups were compared : group 1 ( n = 19 ) PAD rehabilitation ; group 2 ( n = 19 ) PAD rehabilitation + clopidogrel 75 mg once daily ; group 3 ( n = 21 ) home-based training . The training period was 3 months for all groups , which was followed by a 3-month observation phase ( without prescribed training ) . The rehabilitation program consisted of 3 training hours per week . Background variables , demographics , and baseline claudication distances were comparable between groups . After 3 months of training the absolute claudication distances ( ACD ) improved by 82.7 % , 131.4 % , and 5.4 % for groups 1 , 2 and 3 . The initial claudication distances ( ICD ) changed by 163.8 % , 200.6 % , and 44.4 % , respectively . All changes , except the ACD result for group 3 , were statistically significant ( p 0.05 ) . Structured training groups ( 1 and 2 ) performed significantly better than group 3 ( p 0.05 ) . When results from groups 1 and 2 were pooled , ACDs changed from 493.3 218.1 to 1026.0 468.9 m , 546.0 378.8 m [ 95 % CI 417.8 - 674.2 m ] ; p 0.05 . ICDs improved from 175.3 110.8 m to 493.1 326.7 m , 320.8 315.9 m [ 95 % CI 213.9 - 427.7 m ] ; p 0.05 . The difference between the pooled mean results of the structured training groups and the results of group 3 amounted to 474.3 m [ 95 % CI 270.2 - 678.4 m ] and 242.4 m [ 95 % CI 99.0 - 385.7 m ] , for ACD and ICD , respectively . Structured , supervised PAD rehabilitation is a highly efficacious treatment for intermittent claudication and may be regarded as the present gold st and ard among conservative treatment options",
"PURPOSE This study was performed to test the efficacy of a supervised , hospital-based exercise program compared with a home-based exercise program involving minimal supervision , for both walking ability and quality of life measures in patients with exercise-limiting intermittent leg claudication . METHODS Twenty-one patients were assigned r and omly to 12 weeks of supervised exercise or to a home-based exercise group . After 12 weeks the participants in the supervised group transitioned to a home-based program . Both groups were then reevaluated at the end of 24 weeks . The initial claudication distance ( ICD ) and absolute claudication distance ( ACD ) on progressive treadmill exercise was measured at baseline , 12 weeks , and 24 weeks . Additionally , self-reported quality of life status was evaluated using the MOS SF-36 question naire . RESULTS Each group improved ( P ACD from baseline to 12 weeks , which was sustained at the 24-week follow-up . Both groups experienced similar long-term improvements ( P ACD ( 521.5 + /- 253.4 meters to 741.9 + /- 365.6 meters for the supervised group , 532.2 + /- 263.5 meters to 715.0 + /- 394.4 meters in the home group , P not significant , between groups ) . The supervised group experienced a greater improvement ( P ICD after 12 weeks than the home group but not at 24 weeks . The on-site group also experienced significant improvements in ICD after 24 weeks ( P self-reported physical function or mental health as assessed by the MOS SF-36 . CONCLUSION A structured exercise program was more effective in improving the ICD over a 24-week period than a less formal , home-based program . However , if patients are screened properly and receive adequate instruction , a home-based program can be a safe , low-cost alternative providing similar long-term ( 24 weeks ) exercise benefits in ACD",
"OBJECTIVES to compare the effect of surgery , exercise and simple observation on maximum exercise power in claudicants . DESIGN prospect i ve , r and omised study . METHODS a total of 264 unselected claudicants were r and omised to supervised exercise training , invasive treatment ( open surgical or endovascular procedures ) or observation . One year treatment outcomes were analysed on an intention to-treat basis . RESULTS invasively treated patients showed a significant improvement in maximum walking power , stopping distance , post-ischaemic blood flow and big toe pressure at one year . Patients r and omised to physical exercise training or to the control group did not improve in any outcome measure . CONCLUSION invasive treatment increased walking capacity , leg blood pressure and flow . Supervised physical exercise training offered no therapeutic advantage compared to untreated controls",
"BACKGROUND Although there have been many studies showing that exercise training is beneficial for patients with peripheral vascular occlusive disease ( PVOD ) , there is little research comparing various modes of training . Previous studies showed that exercise tests performed on a StairMaster ( StairMaster Sports/Medical Products , Kirkl and , WA ) produce responses similar to those elicited by treadmill tests . The purpose of this study was to compare these modes of exercise in a training program for patients with PVOD . METHODS Of the 23 eligible individuals who began the exercise program , 11 did not complete the regimen due to various complications . Thus , 12 patients were r and omly assigned to train for 12 weeks on either a StairMaster ( n = 6 ) or a treadmill ( n = 6 ) . Patients underwent progressive and single-stage exercise tests on both exercise modalities before and after training . RESULTS Mean exercise time before the onset of claudication pain for all tests rose significantly after training ( P treadmill exercise performance with less improvement noted when tested on the StairMaster , and vice versa ) . Exercise time to maximal pain increased for the training apparatus only ( P foot transcutaneous oxygen tension or the ankle-brachial blood pressure index . CONCLUSIONS Both StairMaster and treadmill training improve the exercise capacity of PVOD patients . The training effect is most apparent for the specific training apparatus , but there is some cross-over improvement to the other exercise modality . Thus , StairMaster training is appropriate and can be part of the exercise prescription for treatment of these patients",
"PURPOSE In patients with intermittent claudication ( IC ) a structured walking exercise program improves exercise performance . However , few studies have evaluated the effects of exercise training on functional status during daily activities . We hypothesized that a supervised exercise training program would improve functional status in patients with IC , with 24 weeks of training more beneficial than 12 weeks . A secondary aim was to evaluate the effects of strength training and combinations of strength and treadmill training on functional status . METHODS Twenty-nine men with disabling IC were r and omized to 12 weeks of either supervised treadmill training ( 3 hr/wk at a work intensity sufficient to produce claudication ) , strength training ( 3 hr/wk of resistive training of six muscle groups of each leg ) , or to a nonexercising control group . Functional status was assessed by question naires characterizing walking ability ( Walking Impairment Question naire , WIQ ) , habitual physical activity level ( Physical Activity Recall , PAR ) , and physical , social , and role functioning , well-being , and overall health ( Medical Outcomes Study SF-20 , MOS ) . Patients alos had their activity levels monitored with an activity monitor ( Vitalog ) . RESULTS After 12 weeks of treadmill training PAR scores increased by 48 metabolic equivalent hr/wk , the MOS physical functioning score by 24 percentage points , and the number of bouts of walking activity measured by the Vitalog by 4.5 bouts/hr ( all p WIQ scores . After 12 additional weeks of treadmill training improvements initially observed in the PAR , MOS , and Vitalog scores were maintained , and in addition the ability to walk distances ( WIQ ) improved by 31 percentage points , and the IC severity score had improved by 29 percentage points ( both p strength training patients improved their WIQ walking speed , stair climbing scores , and MOS well-being scores with no other changes in functional status . Subjects in the control group did not improve functional status by any measure . Twelve weeks of treadmill training after the strength training program maintained WIQ walking speed scores , and activity level defined by Vitalog improved . Twelve weeks of combined treadmill and strength training after the control period had no effect on functional status . CONCLUSIONS A supervised treadmill training program improved functional status during daily activities , with 24 weeks more effective than 12 . In addition , treadmill training alone was more effective in improving functional status in patients with IC than strength training or combinations of the training modalities",
"PURPOSE Exercise training is established for the treatment of peripheral artery disease ; however the additional benefit of pharmacologic therapy with exercise has not been studied . This trial tested the hypothesis that propionyl-L-carnitine ( PLC ) , in combination with monitored home-based exercise training , would improve treadmill peak walking time ( PWT ) over exercise training alone . METHODS Subjects with claudication were r and omized to 6 months of therapy with PLC ( 2 g daily , n = 32 ) or matching placebo ( n = 30 ) . After supervised exercise instruction , all subjects performed exercise training sessions 3 times a week for 30 to 50 minutes/session and compliance was monitored by activity monitors and diary . Change in PWT was the primary outcome measure with other functional assessment s predefined as secondary endpoints . RESULTS After 6 months of treatment , patients r and omized to training and placebo had an increase in PWT of 218 ± 367 seconds , while those r and omized to training plus PLC had an increase of 266 ± 243 seconds , P = .258 . Across the total study cohort , the dose of exercise training ( total number of minutes of exercise of at least moderate intensity ) was correlated with the change in PWT ( r = 0.259 , P = .048 ) , suggesting that the monitored exercise was effective in improving walking performance in both treatment arms . CONCLUSIONS In all subjects , the increase in PWT from baseline to month 6 was correlated with the amount of exercise training . However , although favoring PLC , the combination of exercise training and PLC did not result in a statistically significant benefit in peak treadmill performance or quality of life compared with exercise alone",
"Mika P , Spodaryk K , Cencora A , Unnithan VB , Mika A : Experimental model of pain-free treadmill training in patients with claudication . Am J Phys Med Rehabil 2005;84:756–762 . Objective : Treadmill training in claudication is often based on walking exercise to a pain threshold or longer to the maximum muscle pain of the lower limbs . This kind of exercise may cause an inflammatory response . The purpose of this study was to determine whether pain-free treadmill training using walking exercise to 85 % of the distance to onset of claudication pain can significantly improve pain-free walking distance in patients with intermittent claudication and to evaluate whether this kind of program may induce an inflammatory response leading to the progression of atherosclerosis . Design : A total of 98 patients aged 50–70 yrs with stable intermittent claudication were r and omized into a supervised treadmill training program or a comparison group . Patients in the treatment group participated in 12 wks of supervised treadmill training . We examined the effects of 12 wks of pain-free treadmill training on pain-free walking distance , total leukocyte count , neutrophil count , and microalbuminuria in patients with claudication . Results : A total of 80 participants completed the program . Exercise rehabilitation increased the time to onset of claudication pain by 119.2 % , from 87.4 ± 38 m to 191.6 ± 94.8 m ( P in total leukocyte count , neutrophil count , or microalbuminuria after 12 wks of treadmill exercise ( P > 0.05 ) Conclusion : A pain-free training program can be used in the treatment of claudication as a low-risk program , increasing walking ability without potential harmful effects of ischemia – reperfusion injury",
"BACKGROUND Supervised exercise training ( SET ) is recommended as initial treatment to improve walking capacity in peripheral arterial disease ( PAD ) patients with intermittent claudication . Various mechanisms by which SET yields beneficial effects are postulated , however data regarding its influence on angiogenesis are scarce . Thus , we design ed a prospect i ve r and omized controlled trial to study the impact of SET on markers of angiogenesis and endothelial function in PAD . METHODS Forty PAD patients were r and omized to SET on top of best medical treatment ( SET+BMT ) for 6 months versus best medical treatment ( BMT ) only . Endothelial progenitor cells ( EPC ) were assessed by whole-blood flow cytometry ( co-expression of CD34 + CD133 + KDR+ ) and cell culture assays ( endothelial cell-colony forming units , circulating angiogenic cells , migration assay ) at baseline , 3 , 6 and 12-months after inclusion . Changes of plasma levels of asymmetric dimethylarginine ( ADMA ) , vascular endothelial growth factor ( VEGF ) , stromal cell-derived factor-1 ( SDF-1 ) and maximum walking distance were determined . RESULTS EPC - measured by flow cytometric and cell culture techniques - increased significantly upon training paralleled by a significant decrease of ADMA when compared to the BMT group ( p beneficial effect of SET on EPC diminished , but maximum walking distance was significantly improved compared to baseline and controls ( p VEGF and SDF-1 plasma levels in time course . CONCLUSIONS SET increases circulating EPC counts and decreases ADMA levels reflecting enhanced angiogenesis and improved endothelial function , which might contribute to cardiovascular risk reduction",
"BACKGROUND In this prospect i ve study we evaluated the effects of treadmill training on patients ' walking ability , as well as endothelial function , high-sensitivity C-reactive protein ( hs-CRP ) , and fibrinogen concentration . METHODS A total of 67 patients with stable intermittent claudication were included in a 12-week supervised training program . An observational follow-up period then lasted a mean of 37 weeks . Forty patients completed follow-up . Changes in blood pressure , flow-mediated dilatation ( FMD ) , and treadmill walking performance expressed as maximal walking time ( MWT ) were assessed before and after the training program and during the follow-up period . Moreover , ankle/brachial index ( ABI ) , plasma levels of hs-CRP , fibrinogen , as well as a lipid profile were assessed before and after the training program . RESULTS Maximal walking time improved significantly after treadmill training by 90 % ( p FMD values increased by 43 % ( p training program , and by 29 % ( p=0.058 ) after follow-up , compared to baseline . We noticed a significant decrease in hs-CRP concentration ( p=0.025 ) and an increase in ABI values ( p=0.039 ) in response to the treadmill training program . No effect on lipid profile was observed . CONCLUSIONS The 12-week treadmill training program prolonged the asymptomatic walking distance . The improvement in FMD indicates a systemic effect of the treadmill program on endothelial function . The supervised treadmill training provides an effective and safe treatment option in patients with PAD . The effects of unsupervised exercise during follow-up period after treadmill programs remain tentative and underestimated",
"Introduction : Peripheral atherosclerotic disease ( PAD ) is a condition characterized by low functional capacity which is associated with impaired free living , ambulation and low exercise tolerance . The purpose of this r and omized controlled study was to evaluate whether changes in maximal walking time are associated with adaptations in cardiovascular function following supervised exercise",
"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 assess the effect of pain-free treadmill training on changes of plasma fibrinogen , haematocrit , lipid profile , and walking ability in patients with claudication . Design : R and omized control trial . Methods : Sixty-eight patients with peripheral obstructive arterial disease and intermittent claudication ( Fontaine stage II ) were r and omly assigned into the treadmill training ( repetitive intervals to onset of claudication pain , three times a week ) or a control group ( no change in physical activity ) over 3 months . Both groups performed treadmill test to assess pain-free walking time ( PFWT ) and maximal walking time ( MWT ) and had blood analyses [ for haematocrit , fibrinogen , triglycerides , and cholesterol : total , high-density lipoprotein ( HDL ) and low-density lipoprotein ( LDL ) ] done at baseline and after 6 and 12 weeks of the study . Results : Total and LDL cholesterol levels in the training group decreased ( p Significant ( p ( 19 % ) in the training group but changes of all these lipids were insignificant in the control group over the 3 months . Haematocrit and fibrinogen changes were insignificant in both groups . PFWT was prolonged by 109 % and MWT increased by 54 % in the training group ( p pain-free treadmill training parallels with progressive normalization of lipid profiles in patients with claudication",
"Arm cranking is a useful alternative exercise modality for improving walking performance in patients with intermittent claudication ; however , the mechanisms of such an improvement are poorly understood . The main aim of the present study was to investigate the effects of arm-crank exercise training on lower-limb O2 delivery in patients with intermittent claudication . A total of 57 patients with intermittent claudication ( age , 70+/-8 years ; mean+/-S.D. ) were r and omized to an arm-crank exercise group or a non-exercise control group . The exercise group trained twice weekly for 12 weeks . At baseline and 12 weeks , patients completed incremental tests to maximum exercise tolerance on both an arm-crank ergometer and a treadmill . Respiratory variables were measured breath-by-breath to determine peak VO2 ( O2 uptake ) and ventilatory threshold . Near-IR spectroscopy was used in the treadmill test to determine changes in calf muscle StO2 ( tissue O2 saturation ) . Patients also completed a square-wave treadmill-walking protocol to determine VO2 kinetics . A total of 51 patients completed the study . In the exercise group , higher maximum walking distances ( from 496+/-250 to 661+/-324 m ) and peak VO2 values ( from 17.2+/-2.7 to 18.2+/-3.4 ml.kg-1 of body mass.min-1 ) were recorded in the incremental treadmill test ( P time to minimum StO2 ( from 268+/-305 s to 410+/-366 s ) , a speeding of VO2 kinetics ( from 44.7+/-10.4 to 41.3+/-14.4 s ) and an increase in submaximal StO2 during treadmill walking ( P walking performance after arm-crank exercise training in patients with intermittent claudication is attributable , at least in part , to improved lower-limb O2 delivery",
"OBJECTIVE To determine the effects of a 6-month exercise program on ambulatory function , free-living daily physical activity , peripheral circulation , and health-related quality of life ( QOL ) in disabled older patients with intermittent claudication . DESIGN Prospect i ve , r and omized controlled trial . SETTING University Medical ( Center and Veterans Affairs Medical Center , Baltimore , Maryl and . PARTICIPANTS Thirty-one of 61 patients with Fontaine stage II peripheral arterial occlusive disease ( PAOD ) were r and omized to exercise rehabilitation and 30 to usual-care control . Three patients from the exercise group and six patients from the control group dropped out , leaving 28 and 24 patients , respectively , completing the study in each group . INTERVENTION Six months of exercise rehabilitation . MEASUREMENTS Treadmill distance walked to onset of claudication and to maximal claudication , ambulatory function , peripheral circulation , perceived QOL , and daily physical activity . RESULTS Compliance with the exercise program was 73 % of the possible sessions . Exercise rehabilitation increased treadmill distance walked to onset of claudication by 134 % ( P maximal claudication by 77 % ( P walking economy by 12 % ( P = .003 ) , 6-minute walk distance by 12 % ( P maximal calf blood flow by 30 % ( P Changes in distance walked to maximal pain correlated with changes in walking economy ( r = -.50 , P = .013 ) and changes in maximal calf blood flow ( r = .38 , P = .047 ) . Exercise rehabilitation increased accelerometer-derived daily physical activity by 38 % ( P distance walked to maximal pain ( r = .45 , P = .020 ) . These improvements were significantly better than the changes in the control group ( P exercise rehabilitation in older PAOD patients are dependent on improvements in peripheral circulation and walking economy . Improvement in treadmill claudication distances in these patients translated into increased accelerometer-derived physical activity in the community , which enabled the patients to become more functionally independent",
"OBJECTIVES To investigate the effects of a 24-week program of upper- and lower-limb aerobic exercise training on walking performance in patients with symptomatic peripheral arterial disease ( PAD ) and to study the mechanisms that could influence symptomatic improvement . METHODS After approval from the North Sheffield Local Research Ethics Committee , 104 patients ( median age , 69 years ; range , 50 to 85 years ) with stable PAD were r and omized into an upper- or lower-limb aerobic exercise training group ( UL-Ex or LL-Ex ) , or to a nonexercise training control group . Training was performed twice weekly for 24 weeks at equivalent relative exercise intensities . An incremental arm- and leg-crank test ( ACT and LCT ) to maximum exercise tolerance was performed before and at 6 , 12 , 18 , and 24 weeks of the intervention to determine peak oxygen consumption ( VO(2 ) ) . Walking performance , defined as the claudicating distance ( CD ) and maximum walking distance ( MWD ) achieved before intolerable claudication pain , was assessed at the same time points by using a shuttle-walk protocol . Peak blood lactate concentration , Borg ratings of perceived exertion ( RPE ) and pain category ratio ( CR-10 ) were recorded during all assessment s. RESULTS CD and MWD increased over time ( P CD had improved by 51 % and 57 % , and MWD had improved by 29 % and 31 % ( all P peak heart rate at MWD in the UL-Ex group ( 109 + /- 4 vs 115 + /- 4 beats/min ; P amount of pain experienced in both groups ( P cardiovascular stress and an increased intensity of claudication pain before test termination after training . Patients assigned to exercise training also showed an increase in LCT peak VO2 at the 24-week time point in relation to baseline ( P ACT peak VO2 was only improved in the UL-Ex group ( P upper-limb aerobic exercise training in patients with PAD . Furthermore , that both arm- and leg-crank training could be useful exercise training modalities for improving cardiovascular function , walking performance , and exercise pain tolerance in patients with symptomatic PAD",
"BACKGROUND Treatment for claudication that is due to aortoiliac peripheral artery disease ( PAD ) often relies on stent revascularization ( ST ) . However , supervised exercise ( SE ) is known to provide comparable short-term ( 6-month ) improvements in functional status and quality of life . Longer-term outcomes are not known . OBJECTIVES The goal of this study was to report the longer-term ( 18-month ) efficacy of SE compared with ST and optimal medical care ( OMC ) . METHODS Of 111 patients with aortoiliac PAD r and omly assigned to receive OMC , OMC plus SE , or OMC plus ST , 79 completed the 18-month clinical and treadmill follow-up assessment . SE consisted of 6 months of SE and an additional year of telephone-based exercise counseling . Primary clinical outcomes included objective treadmill-based walking performance and subjective quality of life . RESULTS Peak walking time improved from baseline to 18 months for both SE ( 5.0 ± 5.4 min ) and ST ( 3.2 ± 4.7 min ) significantly more than for OMC ( 0.2 ± 2.1 min ; p significant ( p = 0.16 ) . Improvement in claudication onset time was greater for SE compared with OMC , but not for ST compared with OMC . Many disease-specific quality -of-life scales demonstrated durable improvements that were greater for ST compared with SE or OMC . CONCLUSIONS Both SE and ST had better 18-month outcomes than OMC . SE and ST provided comparable durable improvement in functional status and in quality of life up to 18 months . The durability of claudication exercise interventions merits its consideration as a primary PAD claudication treatment",
"Objectives To assess the effect of pain-free treadmill training on red blood cell deformability and walking distance in patients with claudication . Design R and omized-controlled trial of exercise training . Setting Patients were recruited from the primary care , vascular outpatient clinic . Patients A total of 60 patients with peripheral arterial occlusive disease ( stage II according to Leriche-Fontaine ) were r and omized into the treadmill program or a control group . Fifty-five patients completed the study ( 27 in the exercising group and 28 in the control group ) . Interventions Patients in the exercising group were walking on the treadmill 3 times a week for 3 months . Each session consisted of 1 hour repetitive walking [ performed to 85 % of the pain-free walking time ( PFWT ) ] was supervised by a qualified physiotherapist . Main Outcome Measurements Changes in erythrocyte deformability and treadmill walking performance ( PFWT , maximal walking time ) were assessed in both groups before the study and after 3 months . Results After 3 months of treadmill training , red blood cell deformability in the exercising group significantly increased ( P the erythrocyte deformability in the control group . PFWT was prolonged by 102 % from 191±34 to 386±60 seconds ( P ) , and maximal walking time increased by 49 % from 438±62 to 656±79 seconds ( P 3 months of pain-free treadmill training is associated with a significant increase in red cell deformability in patients with claudication",
"Abstract The efficacy of treadmill walking training to improve pain-free ( PFWD ) and maximal ( MWD ) walking distance in patients with claudication is well documented . The effects of aerobic arm-ergometry to improve PFWD and MWD compared to treadmill walking or usual care are not known . Forty-one participants ( 29 male , 12 female , mean age 67.7 years , 92.7 % smoking history , 36.6 % with diabetes ) with lifestyle-limiting claudication were r and omized to 12 weeks of 3 hours/week of supervised exercise training using either arm-ergometry , treadmill walking , or a combination , versus control . PFWD and MWD were assessed before and after training , and after 12 weeks of follow-up . The 12-week MWD increased significantly in the arm-ergometry ( + 53 % ) , treadmill ( + 69 % ) , and combination ( + 68 % ) groups ( p 24-week MWD was maintained in the arm-ergometry ( p = 0.009 ) and treadmill ( p = 0.019 ) groups , whereas the combination group declined ( p = 0.751 ) versus control . The 12-week PFWD increased significantly in the arm-ergometry group ( + 82 % ; p = 0.025 versus control ) . Change in PFWD in treadmill ( + 54 % ; p = 0.196 versus control ) and combination ( + 60 % ; p = 0.107 versus control ) groups did not reach statistical significance . PFWD improvement was maintained in the arm-ergometry group after a 12-week follow-up ( + 123 % ; p = 0.011 versus control ) . In conclusion , these pilot data demonstrate for the first time that dynamic arm exercise training can improve walking capability in people with peripheral arterial disease (PAD)-induced claudication compared to participants receiving usual care and that improvement was not different from that seen with treadmill walking exercise training . Dynamic arm exercise may be a therapeutic exercise option for patients with PAD",
"OBJECTIVES To assess the efficacy of whole-body progressive resistance training ( PRT ) as a treatment for the symptoms of peripheral arterial disease ( PAD ) in older adults . DESIGN R and omized controlled pilot trial . SETTING University clinical weight training facility in Sydney , Australia . PARTICIPANTS Twenty-two older adults with symptomatic PAD . INTERVENTIONS The efficacy of supervised whole-body high-intensity PRT ( H-PRT ) with low-intensity nonprogressive resistance training ( L-RT ) and a usual care control group that performed unsupervised walking for 6 months was compared . MEASUREMENTS Pilot outcome measures included 6-minute walk ( 6 MW ) outcomes , body composition , dynamic muscle strength and endurance , and performance-based tests of function . RESULTS Mean age was 71.1 ± 7.2 . Mean ankle brachial index was 0.55 ± 0.13 . Exercise adherence was similar in all groups ( P = .29 ) . H-PRT ( n = 8) improved total 6MW distance ( mean difference ( MD ) 62.6 ± 58.0 m , P = .02 ) significantly more than L-RT ( n = 7 ; MD=-48.2 ± 67.6 m ) and controls ( n = 7 ; MD=-9.9 ± 52.9 m ) . Change in 6MW onset of claudication was significantly and independently related to change in bilateral calf endurance ( correlation coefficient ( r ) = 0.65 , P = .03 ) , and change in 6MW distance was significantly and independently related to change in bilateral hip extensor endurance ( r = 0.71 , P = .02 ) in all groups . CONCLUSION H-PRT significantly improved 6MW ability in older adults with intermittent claudication from PAD , whereas L-RT and unsupervised walking did not . Improvement in walking ability was significantly related to improvements in bilateral calf and hip extensor endurance , supporting further investigations targeted at musculoskeletal impairment in this cohort",
"OBJECTIVE To determine the effects of 12-week exercise programme on ambulatory function , free-living daily physical activity and health-related quality of life in disabled older patients with intermittent claudication . DESIGN Prospect i ve , r and omized controlled trial . SETTING University Medical Center and Veterans Affairs Medical Center , Taipei , Taiwan . SUBJECTS Thirty-two of 64 patients with Fontaine stage II peripheral arterial occlusive disease ( PAOD ) were r and omized to exercise training and 32 to usual care control . Five patients from the exercise group and six patients from the control group dropped out , leaving 27 and 26 patients , respectively , completing the study in each group . INTERVENTIONS Twelve weeks of treadmill exercise training . MAIN OUTCOME MEASURES Treadmill walking time to onset of claudication pain and to maximal claudication pain , 6-min walk distance , self-reported ambulatory ability and perceived health-related quality of life ( QOL ) . RESULTS Compliance of exercise programme was 83 % of the possible sessions . Exercise training increased treadmill walking time to onset of claudication pain by 88 % ( P time to maximal pain by 70 % ( P 6-min walk distance by 21 % ( P Perception of health-related QOL improved from 12 % to 178 % in the exercise group . These improvements were significantly better than the changes in the control group ( P claudication following 12-week exercise training in elderly PAOD patients were observed . Increase in treadmill walking time to maximal claudication pain in these patients translated into the improvement of perceived physical health , which enabled the patients to become more functionally independent",
"OBJECTIVE / BACKGROUND Intermittent claudication ( IC ) is associated with a reduction in physical activity ( PA ) and a more rapid functional decline leading to a higher mortality rate compared with healthy individuals . Supervised exercise therapy ( SET ) is known to increase the walking capacity of patients with IC . However , it is unclear whether SET increases PA . The aim of this study was to investigate the effect of SET on PA levels and ambulatory activities in patients with IC . METHODS Patients newly diagnosed with IC were requested to wear an activity monitor 1 week prior to and 1 week immediately after 3 months of SET . The primary outcome was the percentage of patients meeting the minimum recommendations of PA ( American College of Sports Medicine [ACSM]/American Heart Association [ AHA ] recommendation for public health of ≥ 67 metabolic equivalents [METs]/min/day , in bouts of ≥ 10 min ) at baseline and after 3 months of SET . Additionally , daily PA level ( METs/min ) , duration of ambulatory activities , daily number of steps , pain free walking distance ( PFWD ) , maximal walking distance ( MWD ) , and Short Form Health Survey ( SF-36 ) health surveys were compared before and after SET . RESULTS Data from 41 participants were available for analysis . A higher number of participants met the ACSM minimum recommendation for PA at the 3 month follow up ( baseline : 43 % ; 3 months : 63 % ; p = .003 ) . Despite significant increases in PFWD ( baseline : 210 m ; 3 months : 390 m ; p = .001 ) , MWD ( baseline : 373 m ; 3 months : 555 m ; p = .002 ) and physical functioning score ( SF-36 ) following SET , no increase in the mean daily PA level was found ( 395 ± 220 vs. 411 ± 228 METs/min ; p = .43 ) . Furthermore , the total number of steps and time spent in ambulatory activities did not change following SET . CONCLUSION Three months of SET for IC leads to more patients meeting the ACSM/AHA public health minimum recommendations for PA . Assessment of PA could be incorporated as an outcome parameter in future research comparing different treatment modalities for peripheral arterial disease",
"BACKGROUND Uncertainty exists on whether there is adjuvant benefit of percutaneous transluminal angioplasty ( PTA ) over supervised exercise and best medical therapy in the treatment of intermittent claudication . METHODS Patients with symptoms of stable mild to moderate intermittent claudication ( MIMIC ) were r and omised in two multi-centre trials , for femoropopliteal and aortoiliac arterial disease , to receive either PTA or no PTA against a background of supervised exercise and best medical therapy and followed up for 24 months . Initial claudication distance ( ICD ) and absolute walking distance ( AWD ) on treadmill were compared between r and omised groups adjusting for the corresponding measure at baseline . Secondary outcomes included ankle-brachial pressure index ( ABPI ) and quality of life . FINDINGS A total of 93 patients were r and omised into the femoropopliteal trial ( 48 into PTA ) and 34 into the aortoiliac trial ( 19 to PTA ) . The mean ( st and ard deviation , SD ) age was 66(9 ) years for the femoropopliteal trial ( 63 % male ) and 63(9 ) for the aortoiliac trial ( 65 % male ) . At 24 months , there were significant improvements in both AWD and ICD in the PTA groups for both trials . The adjusted AWD was 38 % greater in the PTA group for the femoropopliteal trial ( 95 % ; CI 1 - 90 ) ( p=0.04 ) and 78 % greater in the PTA group for the aortoiliac trial ( 95 % ; CI 0 - 216 ) ( p=0.05 ) . Further benefits were demonstrated for ABPI but not for quality of life . INTERPRETATION PTA confers adjuvant benefit over supervised exercise and best medical therapy in terms of walking distances and ABPI 24 months after PTA in patients with stable mild to moderate intermittent claudication",
"The mechanisms by which exercise training improves intermittent claudication remain unclear . In this article , the effects of local and systemic physiological factors on improved exercise tolerance after a supervised exercise program in claudicants are investigated . A total of 60 patients were r and omized to 3 months of supervised exercise followed by 3 months of unsupervised exercise , or to exercise advice alone ( control ) . Supervised exercise increased both pain-free and maximal walking distances . Heart rate during submaximal exercise and resting mean arterial pressure were lower after supervised exercise at 6 months . Serum lactate at maximum claudication increased significantly after 3 months in the supervised exercise group but this change had resolved by 6 months . Symptomatic improvement was accompanied by modest reductions in mean arterial pressure and submaximal heart rate on exercise . Increased serum lactate at maximum claudication subsequently declined despite continued improvement in walking distance , suggesting local adaptations to improve efficiency of muscle oxygen delivery and /or utilization",
"Objective . Current guidelines for treatment of intermittent claudication ( IC ) do not include a specific recommendation for the intensity of exercise therapy . Thus , the purpose of this study was to determine the relative effectiveness of high versus low intensity exercise for patients with IC , and further to study the effect of such training on blood flow to the legs during exercise . Design . The effect of eight weeks of supervised endurance training was examined in 16 patients with IC . The patients were r and omly assigned to training at intensities corresponding to either 60 % or 80 % of their peak oxygen consumption ( VO2peak ) , respectively . Results . VO2peak and time to exhaustion increased significantly ( 9 % and 16 % , respectively ) more in the high intensity group ( p Blood flow to the legs did not change after training in any of the groups . Conclusion . High intensity training gave larger improvements in VO2peak and time to exhaustion than low intensity training . As blood flow did not change after the exercise program , it is likely that the observed different increase of VO2peak was due to changed mitochondrial oxidative capacity and /or skeletal muscle diffusive capacity",
"OBJECTIVE The initial treatment for intermittent claudication is supervised exercise therapy ( SET ) . Owing to limited capacity and patient transports costs of clinic-based SET , a concept of SET provided by local physiotherapists was developed . We hypothesized that provision of daily feedback with an accelerometer in addition to SET would further increase walking distance . METHODS This multicenter r and omized trial was set in vascular surgery outpatient clinics and included 304 patients with intermittent claudication . Patients were r and omized to exercise therapy in the form of \" go home and walk \" advice ( WA ) , SET , or SET with feedback . Local physiotherapists provided SET . The primary outcome measure was the change in absolute claudication distance . Secondary outcomes were the change in functional claudication distance and results on the Walking Impairment Question naire ( WIQ ) and Short-Form 36 ( SF-36 ) Health Survey after 12 months . RESULTS In 11 centers , 102 , 109 , and 93 patients were included , respectively , in the WA , SET , and SET with feedback groups , and data for 83 , 93 , and 76 , respectively , could be analyzed . The median ( interquartile range ) change in walking distance between 12 months and baseline in meters was 110 ( 0 - 300 ) in the WA group , 310 ( 145 - 995 ) in the SET group , and 360 ( 173 - 697 ) in the SET with feedback group ( P WIQ scores and relevant domains of the SF-36 improved statistically significantly in the SET groups . CONCLUSIONS SET is more effective than WA in improving walking distance , WIQ scores , and quality of life for patients with intermittent claudication . Additional feedback with an accelerometer did not result in further improvement . SET programs should be made available for all patients with intermittent claudication",
"Objectives : To evaluate whether a combination of supervised exercise training and ginkgo biloba treatment is a better treatment than exercise training alone for patients with peripheral arterial disease . Design : A 24-week double-blind , placebo-controlled ginkgo biloba trial with the first 12-week period as a non-exercise control stage and the second 12-week period as an exercise training stage . Setting : Exercise physiology laboratory . Subjects : Twenty-two subjects with peripheral arterial disease . Interventions : The subjects were r and omly allocated into a ginkgo or a placebo group . During the first stage , the ginkgo group ingested st and ardized ginkgo biloba tablets with a daily dosage of 240 mg , while the placebo group received placebo tablets . During the second stage , all subjects engaged in a supervised treadmill-walking programme while continuing to take the same dosage of ginkgo biloba or placebo tablets . Main measures : Walking capacity on treadmill , oxygen consumption during exercise , peripheral haemodynamics and blood viscosity were measured at baseline , and after the first and the second stages of treatment . Results : The ginkgo group did not show significant changes in most of the measured variables after each stage of treatment , except that the maximal walking time was significantly increased after the combined treatment ( from 236 ± 112 seconds to 557 ± 130 seconds , P the placebo group after exercise training ( from 384 ± 125 seconds to 820 ± 146 seconds , P Conclusion : Supervised exercise training combined with ginkgo biloba treatment did not produce greater beneficial effects than exercise training alone in patients with peripheral arterial disease",
"The purpose of this study was to examine the effects of a 12month exercise program on lower limb movement variability in patients with peripheral arterial disease ( PAD ) . Participants ( n=21 ) with an appropriate history of PAD and intermittent claudication ( IC ) volunteered for this study and were r and omly allocated to either a control group ( CPAD-IC ) ( n=11 ) , which received normal medical therapy and a treatment group ( TPAD-IC ) ( n=10 ) , which received normal medical therapy treatment and a 12month supervised exercise program . All participants underwent 2D joint angular kinematic analysis during normal walking to assess lower limb movement variability and walking speed . Between-group differences were analyzed via mixed measures ANOVA . The 12month supervised exercise program made no significant impact on the lower limb movement variability or walking speed of the TPAD-IC group as determined by either intralimb joint coordination or single joint analysis techniques . Long term supervised exercise programs do not appear to influence the lower limb movement variability of PAD-IC patients ",
"Previous studies have demonstrated that supervised strength training ( ST ) or walking training ( WT ) improve walking capacity in patients with claudication . However , it remains unknown whether these improvements would be sustained over a subsequent unsupervised period . This article reports the findings of a study to analyze whether the improvements in walking capacity , achieved with a supervised ST or WT , would be sustained over a subsequent unsupervised therapy period in patients with claudication . Patients were initially r and omized to supervised exercise consisting of ST ( n = 15 ) or WT ( n = 15 ) for 12 weeks . After this period , 12 patients in each group consented to be followed for an additional 12 weeks of unsupervised therapy . Initial claudication distance ( ICD ) and total walking distance ( TWD ) were measured at baseline , after the supervised period ( Week 12 ) and after the unsupervised period ( Week 24 ) . In comparison with baseline values , both groups similarly increased ICD and TWD at Week 12 . From Week 12 to Week 24 , both groups similarly decreased ICD ( ST : -55 ± 110 m and WT : -82 ± 142 m , P = .04 ) and TWD ( ST : -68 ± 186 m and WT : -128 ± 112 m , P groups , ICD ( ST : + 126 ± 149 m and WT : + 50 ± 167 m , P = .01 ) and TWD ( ST : + 104 ± 162 m and WT : + 45 ± 139 m , P = .01 ) at Week 24 remained greater than baseline values . The conclusion is that supervised ST or WT followed by an unsupervised therapy period similarly decreased walking capacity in patients with claudication . However , after the unsupervised period , walking capacity remained at a higher level than before the onset of the supervised exercise-training period",
"OBJECTIVE This study describes the results and functioning of community-based supervised exercise therapy ( SET ) at one year of follow-up . METHODS We conducted a prospect i ve cohort study of community-based SET in regional physiotherapeutic practice s. Consecutive patients with intermittent claudication referred for community-based SET were included . Exclusion criteria for SET were pain at rest or tissue loss . All patients received a diagnostic workup consisting of an ankle-brachial index at rest and after exercise . Interventions were exercise therapy according to the guidelines of the Royal Dutch Society for Physiotherapy . The primary outcome measurement was the increase in absolute claudication distance ( ACD ) , assessed using a st and ardized treadmill protocol by a physiotherapist at baseline and at four , 12 , 26 , and 52 weeks of SET . RESULTS From January 2005 through September 2006 , 349 patients were referred by vascular surgeons for community-based SET . A total of 272 patients with intermittent claudication began the program . Of the 349 initially referred patients , 52 could not perform a st and ard treadmill test but did start community-based SET at a lower level , and 25 patients never started the program . At one year , 129 of the original 272 patients who began community-based SET ( 47.4 % ) were available for analysis of walking distance . In the interim , 143 patients discontinued the program for the following reasons : satisfaction with the acquired walking distance ( n = 19 ) ; unsatisfying results ( n = 26 ) ; not motivated ( n = 22 ) ; (non)vascular intercurrent disease ( n = 48 ) ; and other reasons ( n = 28 ) . ACD increased significantly from a median of 400 m at baseline to 1100 m after 12 months of follow-up ( P Community-based SET seems as effective as SET in a hospital-based approach in improving walking distance , however , it has a high dropout rate",
"Abstract The CLaudication : Exercise Vs Endoluminal Revascularization ( CLEVER ) study is the first r and omized , controlled , clinical , multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication . In this report , the methods and dissemination techniques of the supervised exercise training intervention are described . A total of 217 participants are being recruited and r and omized to one of three arms : ( 1 ) optimal medical care ; ( 2 ) aortoiliac revascularization with stent ; or ( 3 ) supervised exercise training . Of the enrolled patients , 84 will receive supervised exercise therapy . Supervised exercise will be administered according to a protocol design ed by a central CLEVER exercise training committee based on vali date d methods previously used in single center r and omized control trials . The protocol will be implemented at each site by an exercise committee member using training methods developed and st and ardized by the exercise training committee . The exercise training committee review s progress and compliance with the protocol of each participant weekly . In conclusion , a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy , safety and cost-effectiveness for patients with claudication due to peripheral arterial disease ( PAD ) is being evaluated for the first time in CLEVER . The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication result ing from PAD and provide st and ardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice"
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STUDY DESIGN Systematic literature review and meta- analysis . OBJECTIVE To evaluate studies that used arthritis self-management education alone or with exercise to improve Arthritis Self-Efficacy Scale scores of patients with knee osteoarthritis . BACKGROUND Increasing self-efficacy may improve patient knee osteoarthritis symptom management and function . METHODS MEDLINE ( 1946-March 2013 ) , CINAHL ( 1981-March 2013 ) , and PsycINFO ( 1967-March 2013 ) data bases were search ed . RESULTS Twenty-four studies , including 3163 subjects ( women , n = 2547 [ 80.5 % ] ; mean ± SD age , 65.3 ± 6.5 years ) , met the inclusion criteria . A meta- analysis was performed to compare the st and ardized mean difference effect sizes ( Cohen d ) of r and omized controlled studies that used the Arthritis Self-Efficacy Scale pain ( 13 studies , n = 1906 ) , other symptoms ( 13 studies , n = 1957 ) , and function ( 5 studies , n = 399 ) subscales . Cohen d effect sizes were also calculated for cohort studies that used the Arthritis Self-Efficacy Scale pain ( 10 studies , n = 1035 ) , other symptoms ( 9 studies , n = 913 ) , and function ( 3 studies , n = 141 ) subscales . Both r and omized controlled studies and cohort studies were grouped by intervention type ( intervention 1 , arthritis self-management education alone ; intervention 2 , arthritis self-management education with exercise ) , and effect sizes were compared ( Mann-Whitney U tests , P used arthritis self-management education with exercise displayed higher method ological quality scale scores ( 76.8 ± 13.1 versus 61.6 ± 19.6 , P = .03 ) . Statistically significant st and ardized effect-size differences between intervention 1 and intervention 2 were not observed . CONCLUSION Small to moderate effect sizes were observed regardless of whether the intervention included exercise . Exercise interventions used in conjunction with arthritis self-management education programs need to be developed to better enhance the self-efficacy of patients with knee osteoarthritis . LEVEL OF EVIDENCE Therapy , level 2b-
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"AIM This paper is a report of a study to assess the effect of an adapted arthritis self-management programme with an added focus on exercise practice among osteoarthritic knee sufferers . BACKGROUND Osteoarthritis of the knee is a major source of loss of function in older people . Previous studies have found self-management programmes to be effective in increasing arthritis self-efficacy and in mastery of self-management practice . METHOD A r and omized control trial was carried out from December 2002 to May 2003 and 120 participants ( 65.9 % , including 67 in intervention group and 53 in control group ) completed the 16-week postintervention assessment s. Outcome measures included arthritis self-efficacy , use of self-management techniques , pain intensity and daily activity . FINDINGS At 16 weeks , there was a ' statistically ' significant improvement in the arthritis self-efficacy level ( P self-management skills , i.e. use of cold and hot compresses , in two of three joint protective practice s ( P duration of light exercise practice ( P current arthritis pain ( P ability to perform daily activities ( P sufferers of chronic conditions to live with their illness",
"PURPOSE S 1 ) To evaluate the effects of a 12-wk high-intensity knee extensor and flexor resistance training program on strength , pain , and adherence in patients with advanced knee osteoarthritis and varus malalignment and 2 ) to generate pilot data for change in dynamic knee joint load , patent-reported outcomes , and self-efficacy after training . METHODS Fourteen patients ( 48.35 + /- 6.51 yr ) with radiographically confirmed medial compartment knee osteoarthritis and varus malalignment of the lower limb were recruited from a surgical waiting list for high tibial osteotomy . Participants completed a high-intensity isokinetic resistance training program three times per week for 12 wk . Knee extensor and flexor strength were assessed every third week , whereas pain and adherence were recorded at every training session . The external knee adduction moment during the gait , the 6-min-walk test , the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) , and the Arthritis Self-Efficacy Scale ( ASES ) were also evaluated before and after training . RESULTS Significant improvements in knee extensor and flexor strength were observed without increases in pain during or after training . Adherence to the high-intensity program was high . No significant changes were observed for dynamic knee joint load or the KOOS . There was a significant increase in the function subscale of the ASES only . CONCLUSIONS These findings suggest that patients with advanced knee osteoarthritis and malalignment can experience substantial gains in strength after a high-intensity resistance training program without concomitant increases in pain , adverse events , or compromised adherence . These findings provide support for future clinical trials with longer-term outcomes",
"OBJECTIVE Fit and Strong ! is an award winning , evidence -based , multiple-component physical activity/behavior change intervention . It is a group- and facility-based program that meets for 90 minutes 3 times per week for 8 weeks ( 24 sessions total ) . We originally tested Fit and Strong ! using physical therapists ( PTs ) as instructors but have transitioned to using nationally certified exercise instructors ( CEIs ) as part of an effort to translate Fit and Strong ! into community-based setting s , and have tested the impact of this shift in instruction type on participant outcomes . METHODS We used a 2-group design . The first 161 participants to sequentially enroll received instruction from PTs . The next 190 sequential enrollees received instruction from CEIs . All participants were assessed at baseline , at the conclusion of the 8-week Fit and Strong ! program , and at the 6-month followup . RESULTS We saw no significant differences by group on outcomes at 8 weeks or 6 months . Participants in both groups improved significantly with respect to lower-extremity strength , aerobic capacity , pain , stiffness , and physical function . Significant differences favoring the PT-led classes were seen on 2 of 5 mediators , self-efficacy for exercise and barriers adherence efficacy . Participant evaluations rated both types of instruction equally highly , attendance was identical , and no untoward health events were observed or reported under either instruction mode . CONCLUSION Outcomes under the 2 types of instruction are remarkably stable . These findings justify the use of CEIs in the future to extend the reach of the Fit and Strong ! program",
"Background Osteoarthritis ( OA ) is a degenerative disease , considered to be one of the major public health problems . Research suggests that patient education is feasible and valuable for achieving improvements in quality of life , in function , well-being and improved coping . Since 1994 , Primary Health Care in Malmö has used a patient education programme directed towards OA . The aim of this study was to evaluate the effects of this education programme for patients with OA in primary health care in terms of self-efficacy , function and self-perceived health . Method The study was a single-blind , r and omized controlled trial ( RCT ) in which the EuroQol-5D and Arthritis self-efficacy scale were used to measure self-perceived health and self-efficacy and function was measured with Grip Ability Test for the upper extremity and five different functional tests for the lower extremity . Results We found differences between the intervention group and the control group , comparing the results at baseline and after 6 months in EuroQol-5D ( p leg eyes closed ( p = 0.02 ) in favour of the intervention group . No other differences between the groups were found . Conclusion This study has shown that patient education for patients with osteoarthritis is feasible in a primary health care setting and can improve self-perceived health as well as function in some degree , but not self-efficacy . Further research to investigate the effect of exercise performance on function , as well as self-efficacy is warranted . Trial registration The trial is registered with Clinical Trials.gov . Registration number :",
"OBJECTIVE To examine effects of activity strategy training ( AST ) , a structured rehabilitation program taught by occupational therapists and design ed to teach adaptive strategies for symptom control and engagement in physical activity ( PA ) . METHODS A r and omized controlled pilot trial was conducted at 4 sites ( 3 senior housing facilities and 1 senior center ) in southeastern , lower Michigan . Fifty-four older adults with hip or knee osteoarthritis ( mean + /- SD age 75.3+/-7.1 years ) participated . At each site , older adults were r and omly assigned to 1 of 2 programs : exercise plus AST ( Ex + AST ) or exercise plus health education ( Ex + Ed ) . The programs involved 8 sessions over 4 weeks with 2 followup sessions over a 6-month period , and were conducted concurrently within each site . Pain , total PA and PA intensity ( measured objective ly by actigraphy and subjectively by the Community Healthy Activities Model Program for Seniors question naire ) , arthritis self-efficacy , and physical function were assessed at baseline and posttest . RESULTS At posttest , participants who received Ex + AST had significantly higher levels of objective peak PA ( P=0.02 ) compared with participants who received Ex + Ed . Although not statistically significant , participants in Ex + AST tended to have larger pain decreases , increased total objective and subjective PA , and increased physical function . No effects were found for arthritis self-efficacy . CONCLUSION Although participants were involved in identical exercise programs , participants who received AST tended to have larger increases in PA at posttest compared with participants who received health education . Future studies will be needed to examine larger sample s and long-term effects of AST",
"Background COMP ( Cartilage oligomeric matrix protein ) is a matrix protein , which is currently studied as a potential serum marker for cartilage processes in osteoarthritis ( OA ) . The influence of physical exercise on serum COMP is not fully eluci date d . The objective of the present study was to monitor serum levels of COMP during a r and omised controlled trial of physical exercise vs. st and ardised rest in individuals with symptomatic and radiographic knee OA . Methods Blood sample s were collected from 58 individuals at predefined time points before and after exercise or rest , one training group and one control group . The physical exercise consisted of a one-hour supervised session twice a week and daily home exercises . In a second supplementary study 7 individuals were subjected to the same exercise program and sampling of blood was performed at fixed intervals before , immediately after , 30 and 60 minutes after the exercise session and then with 60 minutes interval for another five hours after exercise to monitor the short-term changes of serum COMP . COMP was quantified with a s and wich-ELISA ( AnaMar Medical , Lund , Sweden ) . Results Before exercise or rest no significant differences in COMP levels were seen between the groups . After 60 minutes exercise serum COMP levels increased ( p serum levels decreased ( p = 0.003 ) . Median serum COMP values in sample s obtained prior to exercise or rest at baseline and after 24 weeks did not change between start and end of the study . In the second study serum COMP was increased immediately after exercise ( p = 0.018 ) and had decreased to baseline levels after 30 minutes . ConclusionS erum COMP levels increased during exercise in individuals with knee OA , whereas levels decreased during rest . The increased serum COMP levels were normalized 30 minutes after exercise session , therefore we suggest that sample s of blood for analysis of serum COMP should be drawn after at least 30 minutes rest in a seated position . No increase was seen after a six-week exercise program indicating that any effect of individualized supervised exercise on cartilage turnover is transient",
"Background Studies on exercise in knee osteoarthritis ( OA ) have focused on elderly subjects . Subjects in this study were middle-aged with symptomatic and definite radiographic knee osteoarthritis . The aim was to test the effects of a short-term , high-intensity exercise program on self-reported pain , function and quality of life . Methods Patients aged 36–65 , with OA grade III ( Kellgren & Lawrence ) were recruited . They had been referred for radiographic examination due to knee pain and had no history of major knee injury . They were r and omized to a twice weekly supervised one hour exercise intervention for six weeks , or to a non-intervention control group . Exercise was performed at ≥ 60 % of maximum heart rate ( HR max ) . The primary outcome measure was the Knee injury and Osteoarthritis Outcome Score ( KOOS ) . Follow-up occurred at 6 weeks and 6 months . Results Sixty-one subjects ( mean age 56 ( SD 6 ) , 51 % women , mean BMI 29.5 ( SD 4.8 ) ) were r and omly assigned to intervention ( n = 30 ) or control group ( n = 31 ) . No significant differences in the KOOS subscales assessing pain , other symptoms , or function in daily life or in sport and recreation were seen at any time point between exercisers and controls . In the exercise group , an improvement was seen at 6 weeks in the KOOS subscale quality of life compared to the control group ( mean change 4.0 vs. -0.7 , p = 0.05 ) . The difference between groups was still persistent at 6 months ( p = 0.02 ) . Conclusion A six-week high-intensive exercise program had no effect on pain or function in middle-aged patients with moderate to severe radiographic knee OA . Some effect was seen on quality of life in the exercise group compared to the control group",
"PURPOSE This study assessed the impact of a low cost , multicomponent physical activity intervention for older adults with lower extremity osteoarthritis . DESIGN AND METHODS A r and omized controlled trial compared the effects of a facility-based multiple-component training program followed by home-based adherence ( n = 80 ) to a wait list control group ( n = 70 ) . Assessment s were conducted at baseline and at 2 and 6 months following r and omization . The training program consisted of range of motion , resistance training , aerobic walking , and education-group problem solving regarding self-efficacy for exercise and exercise adherence . All training group participants developed individualized plans for posttraining adherence . RESULTS Relative to the persons in the control group , individuals who participated in the exercise program experienced a statistically significant improvement in exercise efficacy , a 48.5 % increase in exercise adherence , and a 13.3 % increase in 6-min distance walk that were accompanied by significant decreases in lower extremity stiffness at 2 and 6 months . Program participants also experienced a significant decrease in lower extremity pain and a borderline significant improvement in efficacy to adhere to exercise over time at 6 months ( p = .052 ) . In contrast , persons in the control group deteriorated over time on the efficacy and adherence measures and showed no change on the other measures . No adverse health effects were encountered . IMPLICATION S These benefits indicate that this low-cost intervention may hold great promise as one of a growing number of public health intervention strategies for older adults in the United States with osteoarthritis",
"The purpose of this study was to assess the relative effects of coping self-efficacy and catastrophizing on physical functioning . Over a 9-month period , study ing changes in self-efficacy as possible mediator between catastrophizing changes and physical functioning changes might provide evidence for the most promising treatment target . Data came from a r and omized , longitudinal controlled trial comparing exercise , self-management and the two combined to treat 254 individuals with early knee osteoarthritis . A secondary analysis using a bootstrapped linear mixed-effects mediational model produced estimates of both the direct and indirect effects . Results indicated that self-efficacy partially mediated the effect between catastrophizing and physical functioning suggesting that self-efficacy was the more direct treatment target compared to catastrophizing . Treatments targeting both self-efficacy and catastrophizing may have greater impact on physical functioning compared to treatments that focus on only one",
"To evaluate the effects of a revised 6‐week walking program for adults with arthritis , Walk With Ease ( WWE ) , delivered in 2 formats , instructor‐led group or self‐directed",
"The objective of this study was to determine whether the Arthritis Self-Management Programme ( ASMP ) improves perceptions of control , health behaviours and health status , and changes use of health care re sources . The design was a pragmatic r and omized controlled study ; participants were allocated to ASMP ( Intervention Group ) or a 4-month waiting-list Control Group . The Intervention Group completed a 12-month follow-up . In total , 544 people with arthritis were recruited from the community--311 in the Intervention Group and 233 in the Control Group . Main outcome measures included : arthritis self-efficacy , health behaviours ( exercise , cognitive symptom management , diet and relaxation ) and health status ( pain , fatigue , anxiety , depression and positive affect ) . At 4 months follow-up , the ASMP had a significant effect on arthritis self-efficacy for other symptoms and pain subscales . Performance of a range of health behaviours ( cognitive symptom management , communication with physicians , dietary habit , exercise and relaxation ) was significantly greater among the Intervention Group . The Intervention Group were significantly less depressed and had greater positive mood . In addition , trends towards decreases on fatigue and anxiety were noted . Physical functioning , pain and GP visits remained stable at 4 months . A similar pattern of findings was found at 12 months follow-up for the Intervention Group . Furthermore , a significant improvement was found on pain and visits to GPs had decreased . Apart from a small improvement on physical functioning among the Intervention Group participants with osteoarthritis 12 months , all effects were independent of the type of arthritis . The findings suggest that the ASMP is effective in promoting improvements in perception of control , health behaviours and health status , when delivered in UK setting ",
"OBJECTIVES To assess whether OA patients attending a clinical nurse specialist ( CNS ) clinic gain ' additional benefit ' compared with those attending a traditional junior hospital doctor ( JHD ) clinic . METHODS A total of 100 patients with OA attending rheumatology clinics at a UK teaching hospital were r and omly allocated to a CNS or JHD clinic and seen at 0 , 16 , 32 and 48 weeks . The study assessed ( i ) non-inferiority of the CNS with respect to clinical outcomes ( pain , morning stiffness , self-efficacy , physical function and psychological status ) and ( ii ) superiority of the CNS in terms of patient knowledge and satisfaction . RESULTS Average pain at follow-up was lower in the CNS group : unadjusted mean difference for the JHD group minus the CNS group was 5.3 ( 95 % CI -4.6 , 15.2 ) ; adjusted was 1.6 ( 95 % CI -5.7 , 8.9 ) . The corresponding effect size estimates were 0.20 ( 95 % CI -0.17 , 0.57 ) and 0.06 ( 95 % CI -0.21 , 0.33 ) , respectively . There were similar outcomes in morning stiffness , physical function and self-efficacy . Patient knowledge and satisfaction were statistically significant at the 5 % level attaining moderate to large effect sizes in favour of the CNS . CONCLUSIONS Our findings demonstrate that the clinical outcome of CNS care is not inferior to that of JHD care , and patients attending CNS gain additional benefit in that they are better informed about their disease and significantly more satisfied with care than are their counterparts",
"OBJECTIVE To examine the effects of aerobic and resistance exercise on self-efficacy beliefs in older adults with knee osteoarthritis ( OA ) and to determine whether self-efficacy and knee pain mediated the effects of the treatments on stair time performance and health perceptions . METHODS Measures of self-efficacy , knee pain , stair climbing performance , and health perceptions were collected prior to r and omization and again at an 18-month followup in older adults with knee OA who were assigned to 1 of 3 treatment conditions : aerobic exercise , resistance training , or health education control . All analyses were conducted on the intention-to-treat principle . RESULTS Both exercise treatments increased self-efficacy for stair climbing in comparison to the health education control group . Both knee pain and self-efficacy mediated the effect of the treatments on stair climb time , whereas only knee pain mediated health perceptions . CONCLUSIONS The findings suggest that control beliefs and changes in physical symptoms such as knee pain are important outcomes in physical activity programs with patients who have OA of the knee . Moreover , these variables mediate the effects that such programs have on disability and health perceptions",
"OBJECTIVE Studies have shown that patients with knee pain are not well informed of their potential treatment options and that patient preferences are often discordant with physician practice s. The objective of this pilot study was to test the efficacy of a computer tool to improve informed decision-making for patients with knee pain in an outpatient primary care clinic setting . METHODS Patients with knee pain were r and omized to receive an information pamphlet or to perform a computer task . The latter was design ed to elicit preferences based on patient tradeoffs for route of administration , benefits , and side effects of commonly used treatment options for knee pain . After performing the task , participants were given a printed h and out illustrating their preferences . RESULTS In total , 87 patients were r and omized . Decisional self-efficacy , preparedness to participate in decision-making , and arthritis self-efficacy were greater in participants r and omized to the intervention arm compared to those receiving the information pamphlet ( p awareness of choice and evaluate the tradeoffs related to available treatment options were more confident in their ability to obtain information about available treatment options , were better prepared to participate in their visit , and had better arthritis related self-efficacy compared to patients receiving an information pamphlet . The results of this pilot study justify future large-scale trials to determine the effectiveness of similar interventions",
"OBJECTIVE To determine the effects of T'ai Chi training on arthritis self-efficacy , quality of life indicators , and lower extremity functional mobility in older adults with osteoarthritis . DESIGN A prospect i ve , r and omized , controlled clinical trial . Intervention length was 12 weeks , with outcomes measured before and after intervention using blinded testers . Group ( T'ai Chi vs Control ) x time ( 2 x 2 ) mixed factorial ANOVA . SETTING Allied Health Sciences Center at Springfield College , Springfield , MA PARTICIPANTS : A total of 33 community-dwelling participants ( mean age 68 ) diagnosed with lower extremity osteoarthritis and having no prior T'ai Chi training longer than 2 weeks . INTERVENTION T'ai Chi training included two 1-hour T'ai Chi classes per week for 12 weeks . MEASUREMENTS Arthritis self-efficacy ( Arthritis Self-Efficacy Scale ) , quality of life indicators ( Arthritis Impact Measurement Scale ) , functional outcomes ( one-leg st and ing balance , 50-foot walking speed , time to rise from a chair ) . RESULTS T'ai Chi participants experienced significant ( P self-efficacy for arthritis symptoms , total arthritis self-efficacy , level of tension , and satisfaction with general health status . CONCLUSIONS A moderate T'ai Chi intervention can enhance arthritis self-efficacy , quality of life , and functional mobility among older adults with osteoarthritis . T'ai Chi training is a safe and effective complementary therapy in the medical management of lower extremity osteoarthritis",
"OBJECTIVE To evaluate the long-term effects of a spouse-assisted coping skills intervention in patients with osteoarthritis ( OA ) of the knees , and to evaluate how pre- to posttreatment changes in marital adjustment and self-efficacy relate to long-term improvements in pain , psychological disability , physical disability , pain coping , and pain behavior . METHODS A followup study was conducted with 88 OA patients who had been r and omly assigned to 1 of 3 treatment conditions : 1 ) spouse-assisted coping skills training ( spouse-assisted CST ) , 2 ) a conventional CST intervention with no spouse involvement , and 3 ) an arthritis education-spousal support ( AE-SS ) control condition . To evaluate long-term outcome , comprehensive measures of self-efficacy , marital adjustment , pain , psychological disability , physical disability , pain coping , and pain behavior were collected from these individuals at 6 and 12 months posttreatment . RESULTS Data analysis revealed that , at 6-month followup , patients in the spouse-assisted CST condition scored higher on measures of coping and self-efficacy than those in the AE-SS control group . At 6-month followup , patients who received CST without spouse involvement showed a significantly higher frequency of coping attempts and reported higher levels of marital adjustment than those in the AE-SS control group . At 12-month followup , patients in the spouse-assisted CST condition had significantly higher overall self-efficacy than those in the AE-SS control condition . In addition , patients in both the spouse-assisted CST and CST only conditions tended to show improvements in physical disability at the 12-month followup . Individual differences in outcome were noted at the 12-month followup . Patients in the spouse-assisted CST condition who reported initial ( pre- to posttreatment ) increases in marital adjustment had lower levels of psychological disability , physical disability , and pain behavior at 12-month followup . However , for patients in the conventional CST and AE-SS control conditions , increases in marital adjustment occurring over the initial phase of treatment were related to increases in pain and decreases in scores on the Pain Control in Rational Thinking factor of the Coping Strategies Question naire . Finally , patients in the spouse-assisted CST condition who showed pre- to posttreatment increases in self-efficacy were more likely to show decreases in pain , psychological disability , and physical disability at 12-month followup . CONCLUSIONS These findings suggest that spouse-assisted CST can enhance self-efficacy and improve the coping abilities of OA patients in the long term . Individual differences in the long-term outcome of spouse-assisted CST were noted , with some patients ( those showing increases in marital satisfaction and self-efficacy ) showing much better outcomes than others",
"OBJECTIVE To examine changes in mobility-related self efficacy following exercise and dietary weight loss interventions in overweight and obese older adults with knee osteoarthritis ( OA ) , and to determine if self efficacy and pain mediate the effects of the interventions on mobility task performance . METHODS The Arthritis , Diet , and Activity Promotion Trial was an 18-month , single-blind , r and omized , controlled trial comparing the effects of exercise alone , dietary weight loss alone , a combination of exercise plus dietary weight loss , and a healthy lifestyle control intervention in the treatment of 316 overweight or obese older adults with symptomatic knee OA . Participants completed measures of stair-climb time and 6-minute walk distance , self efficacy for completing each mobility task , and self-reported pain at baseline , 6 months , and 18 months during the trial . RESULTS Mixed model analyses of covariance of baseline adjusted change in the outcomes demonstrated that the exercise + dietary weight loss intervention produced greater improvements in mobility-related self efficacy ( P = 0.0035 ) , stair climb ( P = 0.0249 ) and 6-minute walk performance ( P = 0.00031 ) , and pain ( P = 0.09 ) when compared with the healthy lifestyle control intervention . Mediation analyses revealed that self efficacy and pain served as partial mediators of the beneficial effect of exercise + dietary weight loss on stair-climb time . CONCLUSION Exercise + dietary weight loss results in improved mobility-related self efficacy ; changes in these task-specific control beliefs and self-reported pain serve as independent partial mediators of the beneficial effect of exercise + dietary weight loss on stair-climb performance",
"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",
"OBJECTIVE To evaluate the effects of moderate exercise on glycosaminoglycan ( GAG ) content in knee cartilage in subjects at high risk of knee osteoarthritis ( OA ) . METHODS Forty-five subjects ( 16 women , mean age 46 years , mean body mass index 26.6 kg/m(2 ) ) who underwent partial medial meniscus resection 3 - 5 years previously were r and omized to undergo a regimen of supervised exercise 3 times weekly for 4 months or to a nonintervention control group . Cartilage GAG content , an important aspect of the biomechanical properties of cartilage , was estimated by delayed gadolinium-enhanced magnetic resonance imaging of cartilage ( dGEMRIC ) , with results expressed as the change in the T1 relaxation time in the presence of Gd-DTPA ( T1[Gd ] ) . RESULTS Thirty of 45 patients were examined by dGEMRIC at baseline and followup . The exercise group ( n = 16 ) showed an improvement in the T1(Gd ) compared with the control group ( n = 14 ) ( 15 msec versus -15 msec ; P = 0.036 ) . To study the dose response , change in the T1(Gd ) was assessed for correlation with self-reported change in physical activity level , and a strong correlation was found in the exercise group ( n = 16 , r(S ) = 0.70 , 95 % confidence interval [ 95 % CI ] 0.31 - 0.89 ) and in the pooled group of all subjects ( n = 30 , r(S ) = 0.74 , 95 % CI 0.52 - 0.87 ) . CONCLUSION This in vivo cartilage monitoring study in patients at risk of knee OA who begin exercising indicates that adult human articular cartilage has a potential to adapt to loading change . Moderate exercise may be a good treatment not only to improve joint symptoms and function , but also to improve the knee cartilage GAG content in patients at high risk of developing OA",
"PURPOSE We present final outcomes from the multiple-component Fit and Strong ! intervention for older adults with lower extremity osteoarthritis . DESIGN AND METHODS A r and omized controlled trial compared the effects of this exercise and behavior-change program followed by home-based reinforcement ( n=115 ) with a wait list control ( n=100 ) at 2 , 6 , and 12 months . Fit and Strong ! combined flexibility , aerobic walking , and resistance training with education and group problem solving to enhance self-efficacy for exercise and maintenance of physical activity . All participants developed individualized plans for long-term maintenance . RESULTS Relative to controls , treatment participants experienced statistically significant improvements in self-efficacy for exercise ( p=.001 ) , minutes of exercise per week ( p=.000 ) , and lower extremity stiffness ( p=.018 ) at 2 months . These benefits were maintained at 6 months and were accompanied by increased self-efficacy for adherence to exercise over time ( p=.001 ) , reduced pain ( p=.040 ) , and a marginally significant increase in self-efficacy for arthritis pain management ( p=.052 ) . Despite a substantially smaller sample size at 12 months , significant treatment-group effects were maintained on self-efficacy for exercise ( p=.006 ) and minutes of exercise per week ( p=.001 ) , accompanied by marginally significant reductions in lower extremity stiffness ( p=.056 ) and pain ( p=.066 ) . No adverse health effects were seen . Effect sizes for self-efficacy for exercise and for maintenance of physical activity were 0.798 and 0.713 , and 0.905 and 0.669 , respectively , in the treatment group at 6 and 12 months . IMPLICATION S This consistent pattern of benefits indicates that this low-cost intervention is efficacious for older adults with lower extremity osteoarthritis",
"BACKGROUND Osteoarthritis ( OA ) of the knee is associated with a number of physical and psychological impairments . Unfortunately , very few treatment strategies are capable of addressing both types of impairments concurrently . We performed a pilot , r and omized controlled , proof of principle trial investigating the feasibility and effects of an intervention combining physical exercise and pain coping skills training ( PCST ) . METHODS Twenty patients with a clinical and radiographical diagnosis of tibiofemoral OA were r and omized to receive either 10 weeks of physiotherapist supervised exercises ( lower limb strengthening and walking ) combined with non-directive counseling ( NDC ) or the same exercise program delivered concurrently with PCST . Primary outcomes included self-reported pain and pain coping , while secondary outcomes included self efficacy and self-reported physical function . RESULTS Ten participants were r and omized to each group and both groups exhibited significant improvements in isometric knee strength , self-reported knee pain and physical function , self efficacy for control of pain management and other arthritis symptoms . Only those in the exercise + PCST group reported statistically significant improvements in pain control coping and rational thinking . No between-group differences existed in any outcome ( 0.07 , 63 participants per group would be needed for future large-scale studies using similar outcome measures and design . CONCLUSIONS Our study showed that an intervention that combines exercise and PCST within the same treatment session and delivered by specially-trained physiotherapists is feasible and can improve both physical and psychological outcomes in individuals with knee OA . LEVEL OF EVIDENCE Level II Clinical Trials Registry number : ACTRN12609000623291",
"OBJECTIVES The prospect i ve relationships between self-efficacy beliefs , in conjunction with measures of knee pain and knee strength , and subsequent decline in both physical performance and self-reported disability among older adults with knee pain were examined . METHODS In this prospect i ve epidemiological trial , 480 men and women aged 65 years and older who had knee pain on most days of the week and difficulty with daily activity were followed for 30 months . RESULTS There was a significant interaction of baseline self-efficacy with baseline knee strength in predicting both self-reported disability and stair climb performance . Participants who had low self-efficacy and low strength at baseline had the largest 30-month decline in these outcomes . DISCUSSION These data underscore the important role that self-efficacy beliefs play in underst and ing functional decline with chronic disease and aging . Self-efficacy beliefs appear to be most important to functional decline in older adults when they are challenged by muscular weakness in the lower extremities",
"OBJECTIVE Evaluation of a self-management program for patients with osteoarthritis ( OA ) of the hip or knee . The program , which consisted of 6 weekly sessions of 2 hours , included health education by a peer and physical exercises taught by a physical therapist . METHODS R and omized controlled trial . Inclusion criteria were diagnosis of OA of the hip or knee according to ACR clinical and radiographic criteria and age 55 to 75 years . EXCLUSION CRITERIA on waiting list for joint replacement . There were pretest , posttest , and followup ( 6 months ) assessment s. The experimental group consisted of 56 patients , the control group 49 . Outcome variables were pain , quality of life , activity restrictions , knowledge about OA , self-efficacy , body mass index ( BMI ) , and mobility measures . Attention was also paid to effects on health care utilization and lifestyle behavior . RESULTS Significant MANOVA group x time effects ( p pain , quality of life , strength of the left M. quadriceps , knowledge , self-efficacy , BMI , physically active lifestyle , and visits to the physical therapist . Most effects were moderate at posttest assessment and smaller at followup . No effects were found for range of motion and functional tasks . CONCLUSION The program was reasonably effective , but more attention should be paid to proactive followup interventions and to the selection of participants",
"Aims : To establish ( 1 ) the efficacy of a six-week chronic disease management programme for knee osteoarthritis and ( 2 ) whether previous physiotherapy or being wait listed for surgery moderated the outcome of the programme . Design : A pretest , posttest design with multivariate statistical modelling . Participants : One hundred and twenty-one people with severe osteoarthritis who were waiting , or being considered , for surgery . Methods and measures : Western Ontario Osteoarthritis Index ( WOMAC ) scores , arthritis self-efficacy , distress and a patient-rated global indicator of response were collected at baseline , 6 and 12 weeks . History of previous physiotherapy , waiting list status , symptom duration , New Zeal and disease severity score , radiographic changes and self-perceived need for surgery were recorded at baseline . Results : There were moderate improvements in most outcomes ; WOMAC function decreased by 0.29 , WOMAC pain by 0.27 , pain self-efficacy by 4.4 , function self-efficacy by 5.6 and visual analogue scale ( VAS ) distress by 0.2 ( effect sizes ranging from 0.3 to 0.5 at 12 weeks ) . Waiting list status was a significant modifier for function , pain , distress and self-related outcomes . Participants on the waiting list for surgery experienced lesser improvements . Previous physiotherapy was associated with greater improvements in WOMAC scores at six weeks , but not at 12 weeks . Conclusion : The chronic disease management programme could be considered for people with severe knee osteoarthritis , but should be given prior to referral and placement on the waiting list for surgery . Previous physiotherapy should not preclude people from participating in a chronic disease management programme",
"ABSTRACT The primary objective of the present study was to examine the role of pain‐related psychological factors in predicting pain and disability following Total Knee Arthroplasty ( TKA ) . The study sample consisted of 75 ( 46 women , 29 men ) individuals with osteoarthritis of the knee who were scheduled for TKA . Measures of pain severity , pain catastrophizing , depression , and pain‐related fears of movement were completed prior to surgery . Participants completed measures of pain severity and self‐reported disability 6 weeks following surgery . Consistent with previous research , cross‐sectional analyses revealed significant correlations among measures of pre‐surgical pain severity , pain catastrophizing , depression and pain‐related fears of movement . Prospect i ve analyses revealed that pre‐surgical pain severity and pain catastrophizing were unique predictors of post‐surgical pain severity ( 6‐week follow‐up ) . Pain‐related fears of movement were predictors of post‐surgical functional difficulties in univariate analyses , but not when controlling for pre‐surgical co‐morbidities ( e.g. back pain ) . The results of this study add to a growing literature highlighting the prognostic value of psychological variables in the prediction of post‐surgical health outcomes . The results support the view that the psychological determinants of post‐surgical pain severity differ from the psychological determinants of post‐surgical disability . The results suggest that interventions design ed to specifically target pain‐related psychological risk factors might improve post‐surgical outcomes"
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Background The impact of sarcopenia on the outcome of gastrointestinal ( GI ) oncological patients is still controversial . We aim to discuss the prevalence of sarcopenia and its relation to the oncological outcome . Methods Embase , Medline , PubMed , and the Cochrane library were systematic ally search ed for related keywords . Studies using CT to assess sarcopenia and evaluate its relationship with the outcome of GI oncological patients were included . Long-term outcomes , including overall survival and disease-free survival , were compared by hazard ratios ( HRs ) with 95 % confidence intervals ( CIs ) . Short-term outcomes , including total complications and major complications ( Clavien-Dindo ≥IIIa ) after curable surgery , were compared by the risk ratio ( RR ) and 95 % CI . Results A total of 70 studies including 21,875 patients were included in our study . The median incidence of sarcopenia was 34.7 % ( range from 2.1 to 83.3 % ) . A total of 88.4 % of studies used skeletal muscle index ( SMI ) in the third lumbar level on CT to define sarcopenia , and a total of 19 cut-offs were used to define sarcopenia . An increasing trend was found in the prevalence of sarcopenia when the cut-off of SMI increased ( β = 0.22 , 95 % CI = 0.12–0.33 , p increased risk of overall mortality ( HR = 1.602 , 95 % CI = 1.369–1.873 , P with disease-free mortality ( HR = 1.461 , 95 % CI = 1.297–1.646 , P for both total complications ( RR = 1.188 , 95 % CI = 1.083–1.303 , P and major complications ( RR = 1.228 , 95 % CI = 1.042–1.448 , P = 0.014 ) . Conclusion The prevalence of sarcopenia depends mostly on the diagnostic cut-off points of different criteria . Preoperative sarcopenia is a risk factor for both long-term and short-term outcomes
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"Background Despite the positive survival results of cytoreductive surgery ( CRS ) plus hyperthermic intraperitoneal chemotherapy ( HIPEC ) , criticisms have been put forward regarding the safety of this treatment as a result of a high morbidity rate . Muscle depletion ( sarcopenia ) is associated with the occurrence of postoperative complications . The purpose of this study was to determine the association between sarcopenia and postoperative morbidity after CRS-HIPEC for peritoneal carcinomatosis from colorectal cancer by distinguishing the complications linked to CRS itself and those associated with chemotherapy ( HIPEC ) toxicities . Methods Data concerning 97 consecutive patients who had undergone CRS-HIPEC were recorded . We analyzed the events occurring within 30 days after surgery that were prospect ively recorded in a data base . Sarcopenia was assessed using the L3 muscle index on computed tomography performed during the 2 months preceding surgery . Results The sarcopenic patients experienced significantly more chemotherapy toxicities ( 57 vs. 26 % ; p = 0.004 ) and especially neutropenia ( 36 vs. 17 % ; p = 0.04 ) than their nonsarcopenic counterparts . There was no difference in complications linked to the CRS procedure between sarcopenic and nonsarcopenic patients . In the multivariate analysis , sarcopenia was the only parameter independently associated with the risk of chemotherapy toxicity ( odds ratio 3.97 ; 95 % confidence interval 1.52–10.39 ; p = 0.005 ) . Conclusions Despite the local administration of chemotherapy , systemic toxicity was observed in sarcopenic patients after CRS-HIPEC . This relationship favors new treatment strategies with white blood cell growth factors or chemotherapy dosing based on muscle value",
"Objective : The aim of this article was to study the prevalence and significance of sarcopenia in the multimodal management of locally advanced esophageal cancer ( LAEC ) , and to assess its independent impact on operative and oncologic outcomes . Summary of Background Data : Sarcopenia in cancer may confer negative outcomes , but its prevalence and impact on modern multimodal regimens for LAEC have not been systematic ally studied . Methods : Two hundred fifty-two consecutive patients were studied . Lean body mass ( LBM ) , skeletal muscle index ( SMI ) , and fat mass ( FM ) were determined pre-treatment , preoperatively , and 1 year postoperatively . Sarcopenia was defined by computed tomography ( CT ) at L3 as SMI comprehensive complications index ( CCI ) , Clavien-Dindo complication ( CDC ) , and pulmonary complications ( PPCs ) . Multivariable linear , logistic , and Cox regression analysis was performed . Results : In-hospital mortality was 1 % , and CCI was 21 ± 19 . Sarcopenia increased ( P = 0.02 ) from 16 % at diagnosis to 31 % post-neoadjuvant therapy , with loss of LBM ( -3.0 ± 5.4 kg , P not FM ( -0.3 ± 2.7 kg , P= 0.31 ) during treatment . On multivariable analysis , preoperative sarcopenia was associated with CCI ( P = 0.043 ) , and CDC ≥IIIb ( P = 0.003 ) . PPCs occurred in 36 % nonsarcopenic versus 55 % sarcopenic patients ( P = 0.01 ) . Sarcopenia did not impact disease-specific ( P = 0.14 ) or overall survival ( P = 0.11 ) after resection . At 1 year , 35 % had sarcopenia , significantly associated with pre-treatment BMI ( P = 0.013 ) but not complications ( P = 0.20 ) . Conclusions : Sarcopenia increases through multimodal therapy , is associated with an increased risk of major postoperative complications , and is prevalent in survivorship . These data highlight a potentially modifiable marker of risk that should be assessed and targeted in modern multimodal care pathways",
"Background This study aim ed to determine the relationship between intra-abdominal infection ( IAI ) and sarcopenia prospect ively and to construct a nomogram to identify patients at a high risk of IAI . Methods We conducted a prospect i ve study of 682 consecutive patients with gastric cancer who underwent radical gastrectomy . The sarcopenia elements , including lumbar skeletal muscle index , h and grip strength , and gait speed , were measured before surgery . Factors contributing to IAI were determined through univariate and multivariate analysis . A nomogram consisting of the independent risk factors was constructed to quantify the individual risk of IAI . Results Of the 682 patients enrolled in this study , 132 patients were diagnosed with sarcopenia and 61 were diagnosed with IAI . Logistic analysis revealed that sarcopenia , tumor size , pathological type , and multivisceral resection were independent prognostic factors for IAI . The nomogram model for IAI was able to reliably quantify the risk of IAI with a strong optimism-adjusted discrimination ( concordance index , 0.736 ) . Conclusions Sarcopenia is an independent predictor of IAI . Our nomogram was a simple and practical instrument to quantify the individual risk of IAI and could be used to identify patients at a high risk",
"Background / objectives The aim of this study was to examine the impact of visceral fat on surgical complications and long-term survival for patients undergoing radical gastrectomy . Subjects/ methods From 2009 to 2013 , 859 patients who underwent curative resection for gastric cancer were enrolled from a prospect ively maintained data base . Visceral fat area ( VFA ) was assessed by preoperative CT scans . Patients were divided into two groups by VFA . Perioperative variables and postoperative outcomes were compared between the high VFA group and low VFA group . Univariable and multivariable analysis were performed to investigate independent risk factors of postoperative complications and survival . Results Some 859 patients were included in the study , 308 of whom were classified as high VFA . High VFA was correlated with advance age ( P = 0.020 ) , higher albumin levels ( P = 0.001 ) , hemoglobin levels ( P longer surgical duration s ( P = 0.004 ) , higher rate of postoperative complications ( P = 0.004 ) , and longer hospital stays ( P = 0.004 ) . High VFA was identified as the only determinant for surgical complications by logistic regression analysis ( OR , 2.236 , 95 % CI , 1.537–3.254 ; P VFA and overall survival ( OS ) or disease-free survival ( DFS ) . Conclusions Increased VFA independently predicts surgical complications in patients after gastrectomy . However , VFA is not a prognostic biomarker of OS or DFS in patients with gastric cancer",
"BACKGROUND & AIMS Profound weight loss and malnutrition subsequent to severe dysphagia and cancer cachexia are cardinal symptoms in oesophageal cancer ( OC ) . Low muscle mass/sarcopenia has been linked to toxicity during neo-adjuvant therapy in other cancers , with worser effects in sarcopenic obesity . In this study the association between sarcopenia and /or sarcopenic obesity and dose limiting toxicity ( DLT ) during cycle one chemotherapy in resectable OC patients was evaluated . METHODS Body composition was assessed from computed tomography scans of 72 consecutively diagnosed OC patients . Lean body mass and body fat mass were estimated . Patients were grouped as sarcopenic or non-sarcopenic based on pre-defined gender-specific cut-offs for sarcopenia , and as underweight/normal ( BMI developing toxicity were ascertained using multiple logistic regression . RESULTS Of 72 patients , 85 % ( n = 61 ) were males . Sarcopenia and sarcopenic obesity were present in 31 ( 43 % ) and 10 ( 14 % ) , respectively , prior to chemotherapy . Sarcopenic patients had significantly lower adipose tissue index ( p = 0.02 ) compared to non-sarcopenic patients . Patients with DLT ( n = 24 ) had lower skeletal muscle mass ( p = 0.04 ) than those without DLT . Sarcopenic patients ( OR = 2.47 ; 95 % CI : 0.88 - 6.93 ) showed a trend towards increased DLT risk ( p higher DLT risk in sarcopenic patients with normal BMI ( OR = 1.60 ; 95 % CI 0.30 - 8.40 ) , but was non-significant . In the sarcopenic obese , risk of DLT increased significantly ( OR = 5.54 ; 95 % CI 1.12 - 27.44 ) . CONCLUSIONS Sarcopenic and sarcopenic obese OC patients may be at a higher risk for developing DLT during chemotherapy compared to non-sarcopenic OC patients",
"Background With the increased prevalence of obesity and sarcopenia , those patients with both visceral obesity and sarcopenia were at higher risk of adverse outcomes . Aim The aim of this study was to ascertain the combined impact of visceral obesity and sarcopenia on short-term outcomes in patients undergoing colorectal cancer surgery . Methods We conducted a prospect i ve study from July 2014 to February 2017 . Patients ’ demographic , clinical characteristics , physical performance , and postoperative short-term outcomes were collected . Patients were classified into four groups according to the presence of sarcopenia or visceral obesity . Clinical variables were compared . Univariate and multivariate analyses evaluating the risk factors for postoperative complications were performed . Results A total of 376 patients were included ; 50.8 and 24.5 % of the patients were identified as having “ visceral obesity ” and “ sarcopenia , ” respectively . Patients with sarcopenia and visceral obesity had the highest incidence of total , surgical , and medical complications . Patients with sarcopenia or/ and visceral obesity all had longer hospital stays and higher hospitalization costs . Age ≥ 65 years , visceral obesity , and sarcopenia were independent risk factors for total complications . Rectal cancer and visceral obesity were independent risk factors for surgical complications . Age ≥ 65 years and sarcopenia were independent risk factors for medical complications . Laparoscopy-assisted operation was a protective factor for total and medical complications . Conclusion Patients with both visceral obesity and sarcopenia had a higher complication rate after colorectal cancer surgery . Age ≥ 65 years , visceral obesity , and sarcopenia were independent risk factors for total complications . Laparoscopy-assisted operation was a protective factor",
"BACKGROUND Computed tomography ( CT ) can be used for accurate estimation of whole-body muscle mass and muscle density and for detection of sarcopenia . The goal of this study was to evaluate the additional value of CT measured sarcopenia and muscle attenuation alongside the Malnutrition Universal Screening Tool ( MUST ) for the prediction of post-operative morbidity after oncological colorectal resection , whilst correcting for known risk factors . METHODS A prospect i ve cohort study of 80 patients undergoing elective colorectal surgery in the Netherl and s. Patients were screened for nutritional risk upon admission using the MUST . Additionally , preoperative CT scans were used to determine skeletal muscle mass for the detection of sarcopenia and muscle attenuation . Univariate and multivariable analyses were performed to evaluate associations between the MUST , muscle attenuation and sarcopenia on the one h and and post-operative complications measured by the Clavien-Dindo score on the other h and . RESULTS American Society of Anesthesiology-classification ( ASA ) ≥3 , age ≥70 , MUST ≥2 and lower than median muscle attenuation were significantly associated with a higher risk for postoperative complications ( Clavien-Dindo score ≥2 ) ( p ≤ 0.05 ) , whereas sarcopenia was not ( p = 0.59 ) . Multivariate analyses showed that only MUST ≥2 remained significantly associated with postoperative complications when corrected for age ( p = 0.03 , OR 5.8 , 95%CI 1.1 - 29.6 ) , but not when corrected for age ≥70 and ASA ≥3 . Muscle attenuation and sarcopenia were not significantly associated with postoperative complications . CONCLUSION Our results suggest that using CT measured sarcopenia may have only little additional value over the MUST for the prediction of increased short-term post-operative morbidity after oncological colorectal surgery . It also underlines the importance of currently implemented easy-to-use nutritional screening tools ( MUST ) and raises the question of the evaluation of muscle quality versus quantity in body composition imaging . However , further research is needed to investigate the role of sarcopenia for predicting outcome after colorectal surgery , and investigate the role of muscle attenuation measurements for the prediction of muscle function . CATEGORY OF SU BMI SSION : observational study",
"Purpose Preoperative chemo(radio)therapy for oesophageal cancer ( OC ) may have an attritional impact on body composition and functional status , impacting postoperative outcome . Physical decline with skeletal muscle loss has not been previously characterised in OC and may be amenable to physical rehabilitation . This study characterises skeletal muscle mass and physical performance from diagnosis to post-neoadjuvant therapy in patients undergoing preoperative chemo(radio)therapy for OC . Methods Measures of body composition ( axial computerised tomography ) , muscle strength ( h and grip ) , functional capacity ( walking distance ) , anthropometry ( weight , height and waist circumference ) , physical activity , quality -of-life and nutritional status were captured prospect ively . Sarcopenia status was defined as pre-sarcopenic ( low muscle mass only ) , sarcopenic ( low muscle mass and low muscle strength or function ) or severely sarcopenic ( low muscle mass and low muscle strength and low muscle function ) . Results Twenty-eight participants were studied at both time points ( mean age 62.86 ± 8.18 years , n = 23 male ) . Lean body mass reduced by 4.9 ( 95 % confidence interval 3.2 to 6.7 ) kg and mean grip strength reduced by 4.3 ( 2.5 to 6.1 ) kg from pre- to post-neoadjuvant therapy . Quality -of-life scores capturing gastrointestinal symptoms improved . Measures of anthropometry , walking distance , physical activity and nutritional status did not change . There was an increase in sarcopenic status from diagnosis ( pre-sarcopenic n = 2 ) to post-treatment ( pre-sarcopenic n = 5 , severely sarcopenic n = 1 ) . Conclusions Despite maintenance of body weight , functional capacity and activity habits , participants experience declines in muscle mass and strength . Interventions involving exercise and /or nutritional support to build muscle mass and strength during preoperative therapy , even in patients who are functioning normally , are warranted",
"Background The association between sarcopenia and postoperative outcomes for patients with gastrointestinal malignancies remains controversial . This study aim ed to assess the impact of sarcopenia on short- and long-term outcomes after surgery for esophagogastric junction cancer ( EGJC ) or upper gastric cancer ( UGC ) . Methods The study review ed 148 patients with EGJC or UGC who underwent surgical resection . The patients were categorized into the sarcopenia group or the non-sarcopenia group according to their skeletal muscle index calculated using abdominal computed tomography images . The study compared clinicopathologic factors , postoperative complications , and prognosis between the two groups . Results Sarcopenia was present in 19 patients ( 32.2 % ) with EGJC and 23 patients ( 25.8 % ) with UGC . The 5-year overall survival ( OS ) and recurrence-free survival ( RFS ) rates were significantly poorer in the sarcopenia group than in the non-sarcopenia group ( OS 85.5 vs 54.8 % , P = 0.0010 ; RFS 78.7 vs 51.7 % , P = 0.0054 ) . The development of postoperative complications did not differ significantly between the two groups . Both the uni- and multivariate analyses showed that N stage ( P sarcopenia ( P = 0.0024 and 0.0293 , respectively ) were independent poor prognostic factors for OS . Conclusions Sarcopenia was strongly associated with a poor long-term prognosis for patients with EGJC or UGC who underwent surgery . The results suggest that special attention might be needed during the development of treatment strategies for patients with sarcopenia who intend to undergo operations for EGJC and UGC",
"Abstract Currently , the association between sarcopenia and long-term prognosis after gastric cancer surgery has not been investigated . Moreover , the association between sarcopenia and postoperative complications remains controversial . This large-scale retrospective study aims to ascertain the prevalence of sarcopenia and assess its impact on postoperative complications and long-term survival in patients undergoing radical gastrectomy for gastric cancer . From December 2008 to April 2013 , the clinical data of all patients who underwent elective radical gastrectomy for gastric cancer were collected prospect ively . Only patients with available preoperative abdominal CT scan within 30 days of surgery were considered for analysis . Skeletal muscle mass was determined by abdominal ( computed tomography ) CT scan , and sarcopenia was diagnosed by the cut-off values obtained by means of optimum stratification . Univariate and multivariate analyses evaluating risk factors of postoperative complications and long-term survival were performed . A total of 937 patients were included in this study , and 389 ( 41.5 % ) patients were sarcopenic based on the diagnostic cut-off values ( 34.9 cm2/m2 for women and 40.8 cm2/m2 for men ) . Sarcopenia was an independent risk factor for severe postoperative complications ( OR = 3.010 , P total complications . However , sarcopenia did not show significant association with operative mortality . Moreover , sarcopenia was an independent predictor for poorer overall survival ( HR = 1.653 , P disease-free survival ( HR = 1.620 , P sarcopenia remained an independent risk factor for overall survival and disease-free survival in patients with TNM stage II and III , but not in patients with TNM stage I.Sarcopenia is an independent predictive factor of severe postoperative complications after radical gastrectomy for gastric cancer . Moreover , sarcopenia is independently associated with overall and disease-free survival in patients with TNM stage II and III , but not in patients with TNM stage",
"BACKGROUND Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength . This study aims to explore the prevalence of sarcopenia in overweight and obese gastric cancer ( GC ) patients and figured out the impacts of sarcopenia on the postoperative complication of overweight and obese GC patients . METHODS According to the recommended body-mass index ( BMI ) for Asian population s by WHO , we conducted a prospect i ve study of overweight and obese gastric cancer patients ( BMI ≥ 23 kg/m2 ) under curative gastrectomy from August 2014 to December 2015 . Including lumbar skeletal muscle index , h and grip strength and gait speed as the sarcopenic components were measured before surgery . Patients were followed up after gastrectomy to gain the actual clinical outcomes . Factors contributing to postoperative complications were analyzed by univariate and multivariate analysis . RESULTS Total of 206 overweight or obese patients were enrolled in this study , 14 patients were diagnosed sarcopenia and were demonstrated having significantly association with higher risk of postoperative complications , higher hospital costs , and higher rate of 30-days readmission compared with the non-sarcopenic ones . On the basis of univariate and multivariate analysis , sarcopenia was an independent risk factor for postoperative complication of overweight and obese patients with gastric cancer ( P = 0.002 ) . CONCLUSION Sarcopenia is an independent predictor of postoperative complications in overweight or obese patients with gastric cancer after radical gastrectomy",
"Purpose One-year mortality is vital for elderly oncologic patients undergoing surgery . Recent studies have demonstrated that sarcopenia can predict outcomes after major abdominal surgeries , but the association of sarcopenia and 1-year mortality has never been investigated in a prospect i ve study . Methods We conducted a prospect i ve study of elderly patients ( ≥65 years ) who underwent curative gastrectomy for gastric cancer from July 2014 to July 2015 . Sarcopenia was determined by the measurements of muscle mass , h and grip strength , and gait speed . Univariate and multivariate analyses were used to identify the risk factors associated with 1-year mortality . Results A total of 173 patients were included , in which 52 ( 30.1 % ) patients were identified as having sarcopenia . Twenty-four ( 13.9 % ) patients died within 1 year of surgery . Multivariate analysis showed that sarcopenia was an independent risk factor for 1-year mortality . Area under the receiver operating characteristic curve demonstrated an increased predictive power for 1-year mortality with the inclusion of sarcopenia , from 0.835 to 0.868 . Solely low muscle mass was not predictive of 1-year mortality in the multivariate analysis . Conclusions Sarcopenia is predictive of 1-year mortality in elderly patients undergoing gastric cancer surgery . The measurement of muscle function is important for sarcopenia as a preoperative assessment tool",
"OBJECTIVE To determine the association of sarcopenia with postoperative morbidity and mortality after colorectal surgery . BACKGROUND Functional compromise in elderly colorectal surgical patients is considered as a significant factor of impaired postoperative recovery . Therefore , the predictive value of preoperative functional compromise assessment was investigated . Sarcopenia is a hallmark of functional compromise . METHODS A total of 310 consecutive patients who underwent oncologic colorectal surgery were included in a prospect i ve digital data base . Sarcopenia was assessed using the L3 muscle index utilizing Osirix on preoperative computed tomography . Groningen Frailty Indicator and Short Nutritional Assessment Question naire scores were used to assess frailty and nutritional compromise . Predictors for anastomotic leakage , sepsis , and mortality were analyzed by logistic regression analysis . RESULTS Age was an independent predictor of mortality [ P = 0.04 ; odds ratio , 1.17 ; 95 % confidence interval ( CI ) , 1.01 - 1.37 ] . Thirty-day/in-hospital mortality rate in sarcopenic patients was 8.8 % versus 0.7 % in nonsarcopenic patients ( P = 0.001 ; odds ratio , 15.5 ; 95 % CI , 2.00 - 120 ) . Sarcopenia was not predictive for anastomotic leakage or sepsis . Combination of high Short Nutritional Assessment Question naire score , high Groningen Frailty Indicator score , and sarcopenia strongly predicted sepsis ( P = 0.001 ; odds ratio , 25.1 ; 95 % CI , 5.11 - 123 ) , sensitivity , 46 % ; specificity , 97 % ; positive likelihood ratio , 13 ( 95 % CI , 4.4 - 38 ) ; negative likelihood ratio , 0.57 ( 95 % CI , 0.33 - 0.97 ) . CONCLUSIONS Functional compromise in colorectal cancer surgery is associated with adverse postoperative outcome . Assessment of functional compromise by means of a nutritional question naire ( Short Nutritional Assessment Question naire ) , a frailty question naire ( Groningen Frailty Indicator ) , and sarcopenia measurement ( L3 muscle index ) can accurately predict postoperative sepsis",
"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",
"OBJECTIVES This study examined the association of ( change in ) physical activity and decline in mobility performance in older men and women . DESIGN A 3-year prospect i ve study using data of the Longitudinal Aging Study . SETTING Netherl and s. PARTICIPANTS Two thous and one hundred nine men and women aged 55 to 85 . MEASUREMENTS Total physical activity ( expressed as hours per day and kilocalories per day ) and sports participation were measured using a vali date d , interviewer-administered question naire . Mobility performance was assessed using two timed tests : 6-meter walk and repeated chair st and s. RESULTS Mobility performance declined for 45.6 % of the sample . At baseline , the mean time + /- st and ard deviation spent on total physical activity was 3.0 + /- 2.1 h/d or 719 + /- 543 kcal/d , and 56.6 % of the sample participated in sports . Sports participation and a higher level of total physical activity , walking , or household activity were associated with a smaller mobility decline . After 3 years , total physical activity declined , and only 53.4 % of those reporting sports at baseline continued doing so . Continuation of physical activity over time was associated with the smallest decline in mobility . The observed associations were similar for those with and without chronic disease ( P > 0.3 ) . The conclusions did not change after adjustment for potential confounders , including demographic and lifestyle variables , depression , and cognitive status . CONCLUSIONS Physical activity , and especially a regularly active lifestyle , may slow the decline in mobility performance . A beneficial effect was observed for sports and nonsports activities , independent of the presence of chronic disease",
"Background Sarcopenia is characterized by decreased skeletal muscle plus low muscle strength and /or physical performance . This study was performed to determine the association of sarcopenia with short-term postoperative outcomes after gastrectomy for gastric cancer . Methods We conducted a prospect i ve study of 255 consecutive patients with gastric cancer who underwent curative gastrectomy . The sarcopenia elements , including lumbar skeletal muscle index , h and grip strength , and gait speed , were measured before surgery . Patients were followed up after gastrectomy to gain the actual clinical outcomes . Factors contributing to postoperative complications were analyzed by univariate and multivariate analysis . Results Sarcopenia was present in 32 of 255 patients ( 12.5 % ) , and was significantly correlated with advance age , lower body mass index , higher nutritional risk screening ( NRS ) 2002 score , and lower preoperative serum albumin and hemoglobin . Compared with non-sarcopenic patients , sarcopenic patients had a higher risk of postoperative complications , longer postoperative hospital stay , and more hospital costs . In univariate analysis , sarcopenia ( p , nutritional risk ( NRS 2002 score ≥3 ; p = 0.003 ) , advanced age ( ≥75 years ; p = 0.014 ) , anemia ( p = 0.012 ) , hypoalbuminemia ( p = 0.029 ) , and diabetes ( p = 0.014 ) were associated with postoperative complications . Multivariable analysis revealed that sarcopenia ( p Sarcopenia is an independent predictor of postoperative complications in patients with gastric cancer after gastrectomy",
"Background Previous reports suggest that body composition parameters can be used to predict outcomes for patients with gastrointestinal ( GI ) cancers . However , evidence for an association with long-term survival is conflicting , with much of the data derived from patients with advanced disease . This study examined the effect of body composition on survival in primary operable GI cancer . Methods Patients with resectable adenocarcinoma of the GI tract ( esophagus , stomach , colon , rectum ) between 2006 and 2014 were identified from a prospect i ve data base . Computed tomography ( CT ) scans were analyzed using a transverse section at L3 to calculate sex-specific body composition indices for skeletal muscle , visceral fat , and subcutaneous fat . Kaplan – Meier and log-rank analysis were used to compare unadjusted survival . Multivariate survival analyses were performed using a proportional hazards model . Results The study enrolled 447 patients ( 191 woman and 256 men ) with esophagogastric ( OG ) ( n = 108 ) and colorectal ( CR ) ( n = 339 ) cancer . Body composition did not predict survival for the OG cancer patients . Among the CR cancer patients , survival was shorter for those with sarcopenia ( p = 0.017 ) or low levels of subcutaneous fat ( p = 0.005 ) . Older age ( p = 0.046 ) and neutrophilia ( p = 0.013 ) were associated with sarcopenia in patients with CR . Tumor stage ( p = 0.033 ) , neutrophil count ( p = 0.011 ) , and hypoalbuminemia ( p = 0.023 ) were associated with sarcopenia in OG cancer patients . In the multivariate analysis , no single measure of body composition was an independent predictor of reduced survival . ConclusionS arcopenia and reduced subcutaneous adiposity are associated with reduced survival for patients with primary operable CR cancer . However , in this study , no parameter of body composition was an independent prognostic marker when considered with age , tumor stage , and systemic inflammation",
"Background . The association between sarcopenia and postoperative outcomes has been well reported . However , the impact of different sarcopenia stages on postoperative outcomes has never been investigated . Methods . We conducted a large , prospect i ve study of patients who underwent radical gastrectomy for gastric cancer from August 2014 to December 2015 . Sarcopenia was staged as “ presarcopenia , ” “ sarcopenia , ” and “ severe sarcopenia ” according to the definition of the European Working Group on Sarcopenia in Older People . Univariate and multivariate analyses evaluating the risk factors for total , surgical , and medical complications were performed . Results . A total of 470 patients were included , in which 20.6 % , 10 % , and 6.8 % of the patients were identified as having “ presarcopenia , ” “ sarcopenia , ” and “ severe sarcopenia , ” respectively . Postoperative complications , duration of hospital stays , and costs increased with advancing sarcopenia stages . Severe sarcopenia , visceral fat area to total abdominal muscle area ratio , American Society of Anesthesiologists grade III , and tumor located at the cardia were independent risk factors for total complications . Visceral fat area to total abdominal muscle area ratio and tumor located at the cardia were independent risk factors for operative complications . Presarcopenia , sarcopenia , and severe sarcopenia were all identified as independent risk factors for medical complications , as well as age ≥75 years and Charlson Comorbidity Index . Conclusion . Patients had worse postoperative outcomes after gastric cancer operation with advancing sarcopenia stages . Severe sarcopenia , but not presarcopenia or sarcopenia , was an independent risk factor for total postoperative complications . The 3 sarcopenia stages independently influence medical but not surgical complications . Recognizing sarcopenia stages is important for preoperative risk stratification",
"BACKGROUND A geriatric assessment is needed to identify high-risk elderly patients with gastric cancer . However , the current geriatric assessment has been considered to be either time-consuming or subjective . The present study aim ed to investigate the predictive effect of sarcopenia on the postoperative complications for elderly patients who underwent radical gastrectomy . MATERIAL S AND METHODS We conducted a prospect i ve study of patients who underwent radical gastrectomy from August 2014 to December 2015 . Computed tomography-assessed lumbar skeletal muscle , h and grip strength , and gait speed were measured to define sarcopenia . RESULTS Sarcopenia was present in 69 of 240 patients ( 28.8 % ) and was associated with lower body mass index , lower serum albumin , lower hemoglobin , and higher nutritional risk screening 2002 scores . Postoperative complications significantly increased in the sarcopenic patients ( 49.3 % versus 24.6 % , P sarcopenia ( odds ratio : 2.959 , 95 % CI : 1.629 - 5.373 , P the Charlson comorbidity index ≥2 ( odds ratio : 3.357 , 95 % CI : 1.144 - 9.848 , P = 0.027 ) were independent risk factors for postoperative complications . CONCLUSIONS Sarcopenia , presented as a new geriatric assessment factor , was a strong and independent risk factor for postoperative complications of elderly patients with gastric cancer",
"BACKGROUND Preoperative low skeletal muscle mass and density are associated with increased postoperative morbidity in patients undergoing curative colorectal cancer ( CRC ) surgery . However , the long-term effects of low skeletal muscle mass and density remain uncertain . METHODS Patients with stage I-III CRC undergoing surgery , enrolled in a prospect i ve observational cohort study , were included . Skeletal muscle mass and density were measured on CT . Patients with high and low skeletal muscle mass and density were compared regarding postoperative complications , disease-free survival ( DFS ) , overall survival ( OS ) , and cancer-specific survival ( CSS ) . RESULTS In total , 816 patients ( 53.9 % males , median age 70 ) were included ; 50.4 % had low skeletal muscle mass and 64.1 % low density . The severe postoperative complication rate was significantly higher in patients with low versus high skeletal muscle and density ( 20.9 % versus 13.6 % , p = 0.006 ; 20.0 % versus 11.8 % , p = 0.003 ) . Low skeletal muscle mass ( OR 1.91 , p = 0.018 ) and density ( OR 1.87 , p = 0.045 ) were independently associated with severe postoperative complications . Ninety-day mortality was higher in patients with low skeletal muscle mass and density compared with patients with high skeletal muscle mass and density ( 3.6 % versus 1.7 % , p = 0.091 ; 3.4 % versus 1.0 % , p = 0.038 ) . No differences in DFS were observed . After adjustment for covariates such as age and comorbidity , univariate differences in OS and CSS diminished . CONCLUSIONS Low skeletal muscle mass and density are associated with short-term , but not long-term , outcome in patients undergoing CRC surgery . These findings recommend putting more emphasis on preoperative management of patients at risk for surgical complications , but do not support benefit for long-term outcome",
"Objective This study aim ed to determine the risk of severe postoperative complications ( SPCs ) in patients with gastric cancer and to construct a nomogram based on independently related factors to identify high-risk patients . Methods We conducted a prospect i ve study of 636 consecutive patients with gastric cancer who underwent radical gastrectomy . Degrees of sarcopenia and obesity were calculated before surgery . Factors contributing to SPCs were determined using univariate and multivariate analysis . A nomogram consisting of the independent risk factors was constructed to quantify the individual risk of SPCs . Results Logistic analysis revealed that sarcopenic obesity , age , open surgery , and combined resection were independent prognostic factors for SPCs . Sarcopenic obese patients have the highest risk in all patients ( sarcopenic obesity vs normal , OR = 6.575 p = 0.001 ; sarcopenic obesity vs obesity , OR = 5.833 p = 0.001 ; sarcopenic obesity vs sarcopenia , OR = 2.571 p = 0.032 ) , while obese patients share the similar rate of SPCs with normal people ( obesity vs normal , OR = 1.056 p = 0.723 ) . The nomogram we constructed was able to quantify the risk of SPCs reliably ( c-index , 0.737 ) . Conclusions Sarcopenic obesity , together with age , open surgery , and combined resection are independent predictors of SPCs . Obesity will significantly increase the risk of SPCs in sarcopenic patient with gastric cancer , but it will not bring higher risk to normal patients . Our nomogram is a simple and practical instrument to identify patients at high risk of surgical complications",
"Background There is increasing interest in the influence of body composition on oncological outcomes . We evaluated the role of skeletal muscle and fat among patients with gastric cancer ( GC ) who underwent gastrectomy with or without adjuvant chemotherapy , as well as those changes ’ associations with survival outcomes . Methods The present study evaluated 136 patients with GC who were enrolled in the CLASSIC Trial at Yonsei Cancer Center . Baseline body compositions including skeletal muscle area , Hounsfield units ( HU ) , visceral fat area , and subcutaneous fat area were measured by preoperative computed tomography ( CT ) . CT before and after the gastrectomy were used to determine the 6-month relative changes in body composition parameters . Continuous variables were dichotomized according to the best cutoff values by Contal and O’Quigley method . Results Seventy-three patients ( 53.7 % ) underwent surgery alone , and 63 patients ( 46.3 % ) underwent surgery followed by adjuvant chemotherapy . The baseline body composition parameters were not associated with disease-free survival ( DFS ) or overall survival ( OS ) . Except for the HU , the marked loss of muscle , visceral fat , or subcutaneous fat significantly predicted shorter DFS and OS . Patients with a marked loss in at least one significant body composition parameter had significantly shorter DFS ( hazard ratio 2.9 , 95 % confidence interval 1.7–4.8 , P OS ( hazard ratio 2.9 , 95 % confidence interval 1.7–5.0 , P body composition parameters significantly predicted shorter DFS and OS among patients with GC who underwent gastrectomy . Postoperative nutrition and active healthcare interventions could improve the prognosis of these GC patients",
"Purpose Sarcopenia is distinguished by decreased skeletal muscle plus low muscle strength and /or physical performance . This study was design ed to demonstrate the relationship between sarcopenia and systemic inflammatory response ( neutrophil/lymphocyte ratio [ NLR ] , platelet/lymphocyte ratio [ PLR ] , and large platelet/lymphocyte ratio [ LPLR ] ) prior to radical gastrectomy for gastric cancer . Patients and methods We conducted a prospect i ve study of gastric cancer patients who underwent radical gastrectomy . The clinical utility of the NLR , PLR , and LPLR was evaluated by receiver operating characteristic curves . Sarcopenia components including skeletal muscle index , h and grip strength , and 6 m usual gait speed were measured . Logistic analysis was used to identify the independent indices associated with sarcopenia . Results A total of 670 patients were included , representing 504 men and 166 women . Of these , 104 patients ( 15.5 % ) were diagnosed with sarcopenia and 567 ( 84.5 % ) were non-sarcopenia . PLR has a diagnostic sensitivity of 91.3 % for sarcopenia . In addition to the indicators of preoperative age , nutritional risk screening , body mass index , preoperative albumin , and diabetes , the NLR and PLR were independent predictors for sarcopenia ( P patients with operable gastric cancer . Due to the complex assessment of muscle condition , PLR may be used as a primary screening test for sarcopenia . How systemic inflammatory response influences changes in sarcopenia may provide new therapeutic perception toward improving outcomes",
"BACKGROUND : Computed tomography-derived body composition parameters are emerging prognostic factors in colorectal cancer . OBJECTIVE : This study aim ed to determine the roles of sarcopenia , myosteatosis , and obesity as independent and overlapping parameters in stage I to III colorectal cancer . DESIGN : This is a retrospective cohort study from a prospect ively collected data base . Multivariate Cox proportional hazards models were performed to assess the associations between body composition parameters and survival . SETTING S : All patients were seen in a tertiary care cancer center . PATIENTS : Adult patients with stage I to III colorectal cancer , undergoing curative resection from 2007 to 2009 , were included . INTERVENTION : Computed tomography-derived quantification of skeletal muscle and adipose tissues was used to determine population -specific cutoffs for sarcopenia , myosteatosis , and total adiposity . MAIN OUTCOME MEASURES : Primary outcome measures were overall , recurrence-free , and cancer-specific survival . RESULTS : In the 968 patients included , there were a total of 254 disease recurrences and 350 deaths . Body mass index and CT-derived measures of adiposity did not result in worse survival outcomes . Sarcopenia was independently predictive of worse overall ( HR , 1.45 ; 95 % CI , 1.16 - 1.84 ) , recurrence-free ( HR , 1.32 ; 95 % CI , 1.00–1.75 ) , and cancer-specific survival ( HR , 1.46 ; 95 % CI , 1.09–1.94 ) in a multivariate model . Myosteatosis was also independently predictive of overall survival ( HR , 1.53 ; 95 % CI , 1.19–1.97 ) . In a model considering joint effects of sarcopenia and myosteatosis , the presence of both predicted the worst overall ( HR , 2.23 ; 95 % CI , 1.62–3.06 ) , recurrence-free ( HR , 1.53 ; 95 % CI , 1.06–2.21 ) , and cancer-specific survival ( HR , 2.40 ; 95 % CI , 1.69–3.42 ) in a multivariate model . LIMITATIONS : The limitations of this study are inherent in retrospective observational studies . CONCLUSIONS : Sarcopenia and myosteatosis are independent predictors of worse survival in stage I to III colorectal cancer , and their joint effect is highly predictive of reduced overall , recurrence-free , and cancer-specific survival . See Video Abstract at http://links.lww.com/DCR/A923",
"AIM To develop a simple screening test to identify older adults at high risk for sarcopenia . METHODS We studied 1971 functionally independent , community-dwelling adults aged 65 years or older r and omly selected from the resident register of Kashiwa city , Chiba , Japan . Data collection was carried out between September and November 2012 . Sarcopenia was defined based on low muscle mass measured by bioimpedance analysis and either low muscle strength characterized by h and grip or low physical performance characterized by slow gait speed . RESULTS The prevalence of sarcopenia was 14.2 % in men and 22.1 % in women . After the variable selection procedure , the final model to estimate the probability of sarcopenia included three variables : age , grip strength and calf circumference . The area under the receiver operating characteristic curve , a measure of discrimination , of the final model was 0.939 with 95 % confidence interval ( CI ) of 0.918 - 0.958 for men , and 0.909 with 95 % CI of 0.887 - 0.931 for women . We created a score chart for each sex based on the final model . When the sum of sensitivity and specificity was maximized , sensitivity , specificity , and positive and negative predictive values for sarcopenia were 84.9 % , 88.2 % , 54.4 % , and 97.2 % for men , 75.5 % , 92.0 % , 72.8 % , and 93.0 % for women , respectively . CONCLUSIONS The presence of sarcopenia could be detected using three easily obtainable variables with high accuracy . The screening test we developed could help identify functionally independent older adults with sarcopenia who are good c and i date s for intervention"
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PURPOSE This systematic review examines the efficacy of pharmacological therapy for obsessive-compulsive disorder ( OCD ) , addressing two major issues : which treatment is most effective in treating the patient 's symptoms and which is beneficial for maintaining remission . DATA SOURCES Seven data bases were used to acquire articles . The key words used to search for the relative topics published from 1996 to 2007 were " obsessive-compulsive disorder " and " Yale-Brown obsession-compulsion scale . " Based on the inclusion and exclusion criteria , 25 studies were selected from 57 potentially relevant studies . CONCLUSIONS The effects of treatment with clomipramine and selective serotonin reuptake inhibitors ( SSRIs : fluvoxamine , sertraline , fluoxetine , citalopram , and escitalopram ) proved to be similar , except for the lower adherence rate in case of clomipramine because of its side effects . An adequate drug trial involves administering an effective daily dose for a minimum of 8 weeks . An augmentation strategy proven effective for individuals refractory to monotherapy with SSRI treatment alone is the use of atypical antipsychotics ( risperidone , olanzapine , and quetiapine ) . IMPLICATION S FOR PRACTICE Administration of fluvoxamine or sertraline to patients for an adequate duration is recommended as the first-line prescription for OCD , and augmentation therapy with risperidone , olanzapine , or quetiapine is recommended for refractory OCD
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"The purpose of this study was to evaluate the comparative efficacy and tolerability of sertraline and fluoxetine in the treatment of obsessivecompulsive disorder ( OCD ) . Out patients meeting DSM-IV criteria for OCD , with a Yale-Brown Obsessive-Compulsive ( Y-BOCS ) total score ≥ 17 , an NIMH Global Obsessive-Compulsive ( NIMH-OC ) scale score ≥ 7 , and a CGI-Severity score ≥ 4 were r and omized to 24 weeks of double-blind treatment with sertraline ( N = 77 ) or fluoxetine ( N = 73 ) . Primary efficacy measures consisted of the Y-BOCS , the NIMH-OC scale , and the CGI-Severity ( CGI-S ) and Improvement ( CGI-I ) scales . Equivalent and significant ( p in Y-BOCS and NIMH-OC scale scores for sertraline and fluoxetine . After 12 weeks , 49.2 % of patients on sertraline were rated on the CGI-S scale as being mildly ill or not ill compared to 24.6 % on fluoxetine ( p on sertraline to have a statistically nonsignificant 42 % greater likelihood of achieving a response by week 12 ( CGI-I , much or very much improved ; 95 % CI , 0.85 , 2.38;p = 0.18 ) . Sertraline treatment also result ed in a higher proportion of remissions than fluoxetine ( defined as a CGI-I ≤ 2 and a Y-BOCS score ≤ 11 ) , both at week 12 ( 20 % vs. 8 % ; χ2 , 3.95;df 1;p = 0.047 ) and week 24 ( 36 % vs. 22 % ; χ2 , 3.18;df , 1;p = 0.075 ) . Both medications were welltolerated and demonstrated significant efficacy in the treatment of out patients with moderate to severe OCD with the subjects treated with sertraline showing a greater likelihood of remission as well as an earlier improvement on some but not all efficacy",
"Background Although serotonin reuptake inhibitors are effective in the treatment of OCD , many patients fail to respond to these agents . Growing evidence from open-label and placebo-controlled trials suggests a role for augmentation of SRIs with atypical antipsychotics in OCD . Quetiapine is generally well tolerated and previous open-label data has produced mixed results in OCD and additional controlled data is needed . Methods We undertook a double-blind , r and omised , parallel-group , flexible-dose , placebo-controlled study of quetiapine augmentation in subjects who had responded inadequately to open-label treatment with an SRI for 12 weeks . Following informed consent and screening , forty-two subjects were r and omised to either placebo or quetiapine for six weeks . Results There was significant improvement from baseline to endpoint on the Yale-Brown Obsessive-Compulsive Scale in both the quetiapine and placebo groups ( quetiapine , n = 20 , p placebo , n = 21 , p = 0.001 ) with 40 % ( n = 8) of quetiapine and 47.6 % ( n = 10 ) of placebo treated subjects being classified as responders . Quetiapine did not demonstrate a significant benefit over placebo at the end of the six-week treatment period ( p = .636 ) . Similarly quetiapine failed to separate from placebo in the subgroup of subjects ( n = 10 ) with co-morbid tics . Quetiapine was generally well tolerated . Conclusions In this study , quetiapine augmentation was no more effective than placebo augmentation of SRIs . A number of limitations in study design make comparisons with previous studies in this area difficult and probably contributed to our negative findings . Future work in this important clinical area should address these limitations",
"BACKGROUND AND METHODS The adverse effects and potential clinical value of risperidone as augmentation to selective serotonin reuptake inhibitor ( SSRI ) treatment in treatment resistant severe adolescent OCD patients were examined in 17 adolescents ( 15 - 19 years old , 8 males and 9 females ) in an open label trial of risperidone 1 - 2 mg daily . RESULTS After 12 weeks of augmenting treatment , statistically significant improvements were reflected in OCD symptom ratings ( mean total Y-BOCS/CY-BOCS scores after treatment with second SSRI 24.2 + /- 2.6 versus 19.9 + /- 2.9 , p global assessment scores ( mean CGAS , 69.4 + /- 11.4 versus 74.7 + /- 9.6 , p Y-BOCS scores in OCD symptoms . Further 10 patients had a reduction of 10 - 25 % in total score , indicating slight improvement . One patient ( 6 % ) dropped from clinical OCD to a sub clinical level of OCD ( Y-BOCS total score worsened during augmentation treatment . Eight cases had weight gain and sedation was reported in four cases . CONCLUSION These preliminary findings suggest that augmentation with risperidone in dosages up to 2 mg daily might be efficient in adolescents with treatment resistant OCD",
"To examine the efficacy and tolerability of escitalopram in the prevention of relapse in patients with OCD , 468 patients with OCD were treated with open label escitalopram ( 10 mg or 20 mg ) for 16 weeks , after which the 320 responders ( Y-BOCS total score decrease > or = 25 % ) were r and omised to placebo or escitalopram ( at the assigned dose ) for 24 weeks double-blind treatment . The primary analysis ( time to relapse ) showed a significant advantage for escitalopram ( p proportion of patients who relapsed was statistically significantly higher in the placebo group ( 52 % ) than in the escitalopram group ( 23 % ) ( p risk of relapse was 2.74 times higher for placebo compared to escitalopram . Escitalopram was well tolerated and improvements in obsessive-compulsive symptoms reported during the open label period were sustained during the double-blind extension of treatment with active drug . These results demonstrate that escitalopram is effective for long-term treatment and relapse prevention in OCD",
"Despite the effectiveness of clomipramine and selective serotonin reuptake inhibitors ( SSRIs ) in the treatment of obsessive-compulsive disorder ( OCD ) , 40 % to 60 % of patients who receive an adequate treatment with these agents have significant persisting symptoms . Newer atypical antipsychotic drugs showed efficacy as augmenting agents in patients with OCD resistant to serotonin reuptake inhibitors ( SRIs ) . The objective of this study was to evaluate the efficacy and safety of amisulpiride augmentation in treatment resistant OCD . A total of 20 patients diagnosed with OCD according to DSM-IV criteria and having a history of resistance to treatment with SRIs were included in the study . Amisulpiride 200 mg/day was added to ongoing SRI treatment and titrated up to 600 mg/day in flexible doses . The mean amisulpiride dose was 325 + /- 106 mg/day . The patients were assessed with the Yale-Brown obsessive-compulsive scale ( Y-BOCS ) at baseline and at week 12 of amisulpiride treatment . Side effects were monitored by the UKU side effect rating scale . The reduction in Y-BOCS scores between the baseline ( 26.7 + /- 6.3 ) and the end of the treatment ( 12.5 + /- 2.8 ) was statistically significant ( p=0.0001 ) . The most commonly observed side effects included weight gain ( 14 patients , 70 % ) , mild sedation ( 13 patients , 65 % ) and asthenia ( 7 patients , 35 % ) . This study has several limitations and , hence , the results are preliminary and require confirmation in a r and omized controlled trial . In conclusion , this study suggests that amisulpiride may be a promising option as an augmentation strategy in treatment resistant OCD",
"Background : Two thirds of patients with obsessive-compulsive disorder ( OCD ) respond to treatment with selective serotonin reuptake inhibitors ( SSRIs ) . The neurobiological mechanisms of SSRI action and failure to respond to SSRI treatment remain to be eluci date d. Objectives : The aim of this pilot study was to quantify changes in the availability of serotonin transporter ( SERT ) in the course of SSRI treatment and to relate these changes to improvements of clinical symptoms . Methods : Ten patients with OCD were investigated at baseline and 5 of them after 1 year of SSRI treatment with citalopram 60 mg per day using brain single photon emission computed tomography and [123I]β-CIT . Specific-to-nondisplaceable [123I]β-CIT binding ratios ( V3″ ) were calculated in SERT-rich brainstem , midbrain and thalamus using a magnetic resonance imaging-based region of interest ( ROI ) analysis . Symptom severity was evaluated with the Yale-Brown Obsessive-Compulsive Scale ( Y-BOCS ) . Results : V3″ differed significantly between pretreatment and follow-up scans in all three brain regions , thalamus , midbrain as well as in brainstem . In thalamic ROI , differ ences in SERT availability and Y-BOCS ratings correlated . In midbrain , a trend toward a significant association was found . In brainstem , no relationship was revealed . Conclusions : Higher occupancy of SERT by citalopram seems to be associated with better clinical response after 1 year of SSRI treatment of patients with OCD",
"BACKGROUND To date , only 1 controlled study has found a drug ( haloperidol ) to be efficacious in augmenting response in patients with obsessive-compulsive disorder ( OCD ) refractory to serotonin reuptake inhibitor ( SRI ) monotherapy ; patients with comorbid chronic tic disorders showed a preferential response . This report describes the first controlled study of risperidone addition in patients with OCD refractory to treatment with SRI alone . METHODS Seventy adult patients with a primary DSM-IV diagnosis of OCD received 12 weeks of treatment with an SRI . Thirty-six patients were refractory to the SRI and were r and omized in a double-blind manner to 6 weeks of risperidone ( n = 20 ) or placebo ( n = 16 ) addition . Behavioral ratings , including the Yale-Brown Obsessive Compulsive Scale , were obtained at baseline and throughout the trial . Placebo-treated patients subsequently received an identical open-label trial of risperidone addition . RESULTS For study completers , 9 ( 50 % ) of 18 risperidone-treated patients were responders ( mean daily dose , 2.2 + /-0.7 mg/d ) compared with 0 of 15 in the placebo addition group ( P risperidone addition responded . Risperidone addition was superior to placebo in reducing OCD ( P , depressive ( P and anxiety ( P = .003 ) symptoms . There was no difference in response between OCD patients with and without comorbid diagnoses of chronic tic disorder or schizotypal personalty disorder . Other than mild , transient sedation , risperidone was well tolerated . CONCLUSION These results suggest that OCD patients with and without comorbid chronic tic disorders or schizotypal personality disorder may respond to the addition of low-dose risperidone to ongoing SRI therapy",
"There is evidence of the clinical efficacy and safety of clomipramine and the newer selective serotonin reuptake inhibitors ( SSRIs ) for the treatment of obsessive-compulsive disorder ( OCD ) . In the present study , we have compared the efficacy and safety of 40 mg/day of fluoxetine and 150 mg/day of clomipramine in patients with OCD , diagnosed according to DSM-IIIR . A total of 55 patients entered this 8-week , double-blind controlled study . Efficacy for both drugs was comparable . The primary efficacy criterion , the Y-BOCS Total score , did not show any significant differences between treatment arms . Response rate was higher with clomipramine , using a 25 % decrease in Y-BOCS Total score as response threshold , but there were no significant differences between treatment arms using a 35 % threshold . Overall safety and tolerability were good for both drugs , being slightly better for fluoxetine",
"The aim of this study was to compare the efficacy , safety , and tolerability of sertraline and clomipramine in the treatment of obsessive-compulsive disorder ( OCD ) . Out patients with DSM-III-R defined OCD for 1 year or longer and scores of > /=20 on the YaleBrown Obsessive Compulsive Scale ( Y-BOCS ) , > /=7 on the National Institute of Mental Health Global Obsessive-Compulsive Scale ( NIMH-OC ) , > /=4 on the Clinical Global Impression Severity of Illness Scale ( CGI-S ) and Hamilton Depression Scale ( 17 item HAMD ) were r and omized to sertraline ( n = 86 ) or clomipramine ( n = 82 ) once daily for 16 weeks . Initial daily doses of sertraline and clomipramine were 50 mg . After a minimum of 4 weeks , these doses could be increased by 50 mg increments every 2 weeks to a maximum of 200 mg daily if the response was thought inadequate . Efficacy was assessed at the end of 1 , 2 , 4 , 6 , 8 , 12 and 16 weeks of therapy using the Y-BOCS , NIMH-OC , CGI-S , CGI Improvement Scale ( CGI-I ) and Clinical Anxiety Scale ( CAS ) . One hundred sixty-eight patients were r and omized and received at least one dose of double-blind medication ; 86 received sertraline and 82 clomipramine . Mean final daily doses at final visit were clomipramine 90 mg ( efficacy evaluable patients 101 mg , completers 110 mg ) , and sertraline 129 mg ( efficacy evaluable patients 132 mg , completers 136 mg ) . Mean baseline Y-BOCS , NIMH-OC and CGI-S totals were 27.7 , 10.1 and 5.5 , respectively , for sertraline and 27.4 , 9.9 and 5.5 , respectively , for clomipramine . Sertraline demonstrated greater efficacy than clomipramine in the intent-to-treat patient group : mean baseline to final visit changes were 50.8 % ( Y-BOCS ) , 41.9 % ( NIMH-OC ) and 37.7 % ( CGI-S ) for sertraline and 42.9 % ( Y-BOCS ) , 33.8 % ( NIMH-OC ) and 30.0 % ( CGI-S ) for clomipramine ( P withdrawing because of adverse events was substantially greater for clomipramine ( 26 % ) than sertraline ( 11 % ) ( P adverse events for clomipramine were dry mouth ( 20 % ) , anxiety ( 17 % ) , constipation ( 16 % ) , nausea ( 15 % ) and somnolence ( 11 % ) , and for sertraline , diarrhea ( 12 % ) and nausea ( 12 % ) . In this study , sertraline was more effective than clomipramine in the intent-to-treat analysis . The difference in efficacy between the treatments is almost wholly accounted for by a greater number of clomipramine withdrawals due to the poor patient acceptance of clomipramine . The superior tolerability of sertraline and the lower rate of premature treatment withdrawal relative to clomipramine may offer considerable quality of life and compliance benefits in the long-term management of a chronic disorder such as OCD",
"OBJECTIVE The aim of this 12-week , double-blind , flexible-dose , placebo-controlled , parallel-arm , multicenter trial was to determine the safety and efficacy of fluvoxamine in a controlled-release ( CR ) formulation in adult out patients with obsessive-compulsive disorder ( OCD ) . METHOD 253 adult out patients with DSM-IV OCD were r and omly assigned to receive 100 to 300 mg of fluvoxamine CR ( N = 127 ) or placebo ( N = 126 ) once daily for 12 weeks . Intent-to-treat analyses of efficacy assessment s with the Yale-Brown Obsessive Compulsive Scale ( YBOCS ) , Clinical Global Impressions-Severity of Illness scale ( CGI-S ) , and Clinical Global Impressions-Improvement scale ( CGI-I ) were conducted . RESULTS Fluvoxamine CR was significantly ( p YBOCS total score beginning at week 2 . This early response was sustained at all subsequent visits . At endpoint , there was a mean decrease of 8.5 + /- 0.7 ( 31.7 % ) in the YBOCS total score compared with baseline in the fluvoxamine CR treatment group versus a mean decrease of 5.6 + /- 0.7 ( 21.2 % ) in the placebo group ( p = .001 ) . Fluvoxamine CR was also significantly superior to placebo in lowering the severity of illness ( CGI-S , p = .002 ) and in producing clinical improvement ( CGI-I , p fluvoxamine CR treatment was associated with a statistically significant and clinical ly relevant reduction in OCD severity and was found to be safe and well tolerated . The early onset of therapeutic effect , starting from week 2 , was of particular interest",
"According to previous data , the addition of risperidone in obsessive-compulsive patients refractory to serotonin reuptake inhibitors ( SRIs ) is shown to be a safe and effective treatment strategy . The aims of our study were to evaluate the efficacy of risperidone addition , in comparison to placebo , in fluvoxamine-refractory obsessive-compulsive patients and to investigate whether risperidone could boost the efficacy of fluvoxamine in fluvoxamine-responder patients . Subjects were 45 obsessive-compulsive in patients , consecutively recruited at the Department of Neurosciences at the San Raffaele Hospital , Milan . Thirty-nine patients completed the study . All patients received 12 weeks of a st and ardized open-label fluvoxamine monotherapy and then continued for 6 weeks with placebo or risperidone in a double-blind design . Results showed a significant effect of risperidone addition , at the end of the double-blind phase ( 18th week ) , only for fluvoxamine-refractory patients . Five patients on risperidone ( 50 % ) and two ( 20 % ) on placebo became responders , with a Yale-Brown Obsessive-Compulsive Scale ( Y-BOCS ) decrease > or = 35 % . Risperidone was generally well tolerated , except for a mild transient sedation and a mild increase in appetite . This preliminary study suggests that even very low ( 0.5 mg ) risperidone doses are effective in OC patients who were nonresponders to a st and ardized treatment with fluvoxamine",
"OBJECTIVE Obsessive-compulsive disorder ( OCD ) typically begins early in life and has a chronic course . Despite the need for long-term treatment , the authors found no placebo-controlled studies that have examined the relapse-prevention efficacy of maintenance therapy . METHOD Patients who met criteria for response after 16 and 52 weeks of a single-blind trial of sertraline were r and omly assigned to a 28-week double-blind trial of 50 - 200 mg/day of sertraline or placebo . Primary outcomes after the double-blind trial were full relapse , dropout due to relapse or insufficient response , or acute exacerbation of OCD symptoms . RESULTS Of 649 patients at baseline , 232 completed 52 weeks of the single-blind trial and met response criteria . Among the 223 patients in the double-blind phase of the study , sertraline had significantly greater efficacy than placebo on two of three primary outcomes : dropout due to relapse or insufficient clinical response ( 9 % versus 24 % , respectively ) and acute exacerbation of symptoms ( 12 % versus 35 % ) . Sertraline result ed in improvement in quality of life during the initial 52-week trial and continued improvement , significantly superior to placebo , during the subsequent 28-week double-blind trial . Long-term treatment with sertraline was well tolerated . Over the entire study period , less than 20 % of the patients stopped treatment because of adverse events . CONCLUSIONS Sertraline demonstrated sustained efficacy among patients responding to treatment and was generally well tolerated during the 80-week study . During the study 's last 28 weeks , sertraline demonstrated greater efficacy than placebo in preventing dropout due to relapse or insufficient clinical response and acute exacerbation of OCD symptoms",
"The efficacy and tolerability of fluvoxamine ( 100 - 300 mg/day ) and clomipramine ( 100 - 250 mg/day ) were compared in a r and omized , double-blind , parallel-group study of 79 patients with obsessive-compulsive disorder ( OCD ) without coexisting major depression . After a 2-week placebo lead-in period , patients were r and omized to fluvoxamine ( 37 patients ) or clomipramine ( 42 patients ) for 10 weeks . Efficacy was evaluated with the Yale-Brown Obsessive-Compulsive Scale ( Y-BOCS ) , the National Institute of Mental Health Obsessive-Compulsive scale , and Patient and Clinical Global Improvement scales . Hamilton Rating Scale for Depression scores and somatic symptoms were also assessed . Seventy-eight percent of fluvoxamine patients and 64 % of clomipramine patients completed the study . At the end of treatment , 56 % of fluvoxamine patients were classified as responders ( > or = 25 % decrease in Y-BOCS score ) , compared with 54 % of clomipramine patients . Both groups showed steady improvement throughout the study ; no statistically significant differences were observed between the groups for any efficacy variable at any time . A similar percentage of patients in both groups withdrew because of adverse events . No serious adverse events related to drug occurred with either drug . Insomnia , nervousness , and dyspepsia were more statistically frequent with fluvoxamine ; dry mouth and postural hypotension were more frequent with clomipramine . In this study , fluvoxamine and clomipramine were equally effective in reducing OCD symptoms over a 10-week treatment period but displayed different side effect profiles",
"This study aim ed to determine the efficacy and tolerability of adding quetiapine to a serotonin reuptake inhibitor in treatment-resistant obsessive – compulsive disorder ( OCD ) . Twenty-one adult treatment-resistant OCD patients were r and omized to 16 weeks of augmentation with either quetiapine ( n=11 ) or placebo ( n=10 ) . Patients with significant comorbidities , including tic-spectrum disorders , were not included . The treatment was well tolerated , with only one premature dropout in each treatment-group . The primary analysis showed that individuals in the quetiapine-treated group showed a 14 % mean improvement in baseline Yale – Brown Obsessive – Compulsive Scale scores at study endpoint compared with a 6 % improvement in those treated with placebo , but this difference did not reach statistical significance ( F quetiapine met criteria for clinical response , compared to one patient who was treated with placebo . Larger studies are needed to explore the efficacy of second generation antipsychotics , such as quetiapine , when used as adjunct treatment in resistant OCD",
"This double blind , r and omized , parallel , placebo-controlled study investigates whether clonazepam accelerates and / or increases the overall response in patients with obsessive compulsive disorder ( OCD ) who are treated with sertraline . Thirty-seven patients were r and omized with 20 in the sertraline and clonazepam group and 17 in the sertraline and placebo groups . Male and female out patients , age 18 - 65 years , met criteria for a primary diagnosis of obsessive compulsive disorder according to DSM-IV , as determined by the structured clinical MINI interview . Appropriate safety and efficacy parameters were measured throughout the study . The determination of efficacy was based primarily on changes from baseline to the last observation taken through week 12 . Analysis revealed no significant difference between groups at endpoint on the main scale",
"Recently , atypical antipsychotics have been used for the management of the patients with refractory obsessive – compulsive disorder ( OCD ) . The aim of the present study was to evaluate the results of quetiapine augmentation to a serotonin reuptake inhibitor ( SRI ) in the patients with refractory OCD . Fifty-two patients with OCD according to DSM-IV entered 3 months of an open-label phase treatment with a SRI with or without concomitant adjunctive treatment regimen . Of them , 27 patients were refractory OCD . These patients were r and omly divided into two groups , SRI plus quetiapine and SRI plus placebo , for an 8-week single-blind phase . The course of OCD was evaluated by Yale – Brown Obsession – Compulsion ( Y-BOCS ) and Clinical Global Impression – Severity of Illness and Improvement ( CGI-SI and I ) Scales every other week for 8 weeks . Of the 14 patients in group I , nine ( 64.4 % ) showed significant improvement with 60 % or greater improvement on the Y-BOCS and one ( 7.1 % ) partial improvement with 30 % or greater improvement on the Y-BOCS , whereas no improvement was observed in group II . The addition of quetiapine to ongoing SRI therapy has been found to be effective and well-tolerated approach in patients with refractory OCD",
"Some meta-analyses have suggested that the selective serotonin reuptake inhibitors ( SSRIs ) are less effective than clomipramine in the treatment of obsessive-compulsive disorder ( OCD ) . The aim of this double-blind , r and omised , multicentre study was to directly compare the efficacy and safety of fluvoxamine and clomipramine in patients with OCD . A total of 227 patients were r and omised to flexible doses of fluvoxamine or clomipramine ( both 150 - 300 mg/day ) for 10 weeks . Fluvoxamine and clomipramine were both clinical ly effective and there were no statistically significant differences between the two treatment groups , at any visit , on the National Institute of Mental Health Obsessive-Compulsive global rating scale , the Yale-Brown Obsessive-Compulsive scale ( total score and obsession and compulsion subscores ) , the Clinical Global Impression severity of illness and global improvement subscales , the Clinical Anxiety Scale and the 17-item Hamilton Depression Rating Scale . However , there were differences in safety between the two treatments . Compared with fluvoxamine-treated patients , those treated with clomipramine had more anticholinergic side effects ( dry mouth , constipation and tremor ) and premature withdrawals due to adverse events ( 18 versus 9 ) . The results from this controlled study indicate that fluvoxamine is as effective as clomipramine in the treatment of OCD but has a better tolerability profile . Copyright 2001 John Wiley & Sons ,",
"The aim of the present study was to investigate the effect of adjunctive olanzapine in patients with obsessive-compulsive disorder ( OCD ) refractory to paroxetine . Twenty-one patients unresponsive to treatment with paroxetine , administered for at least 12 weeks at the dose of 60 mg/day , participated to a 12-week open-label , add-on trial with olanzapine ( 10 mg/day ) . The psychopathological state was evaluated by the Yale-Brown Obsessive-Compulsive Scale ( Y-BOCS ) and by Clinical Global Impression ( CGI ) . Three patients did not complete the 12-week adjunctive treatment with olanzapine . In the 18 completers , the mean Y-BOCS score decreased significantly from 27.1+/-4.0 at baseline to 20.1+/-3.9 at final evaluation ( P Steady-state plasma concentrations of paroxetine were not modified during olanzapine coadministration . The drug combination was generally well tolerated and initial sedation and weight gain were the most frequent unwanted effects . Our findings confirm the results of previous studies and indicate that the addition of olanzapine to ongoing treatment with serotonin reuptake inhibitors ( SRI ) may be beneficial in some patients unresponsive to SRI monotherapy",
"The present study reports the results of an open-label trial on the use of the combination of olanzapine ( an atypical antipsychotic ) serotonin reuptake inhibitors ( SRIs ) in 26 resistant out patients affected by resistant obsessive-compulsive disorder ( OCD ) . All patients had been suffering from OCD , according to DSM IV criteria , for at least 2 years and had different comorbid disorders ; they had been treated with an SRI at adequate dosages for at least 6 months , or had tried different augmentation strategies with no or poor response . As a result , olanzapine was added and continued for 1 year . After 12 weeks of this regimen , most of the patients ( 17 ) had shown a reduction in OC symptoms , as assessed by a decrease in the Yale-Brown Obsessive Compulsive Scale total score , which continued throughout subsequent months . Only mild side-effects were recorded and no patient halted the treatment . The addition of olanzapine would appear to be a useful short- and long-term strategy for augmenting SRI effectiveness in resistant OCD patients , especially in those presenting comorbidity with bipolar disorders "
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4117465a-06ff-11f0-808a-c43d1ab1c353
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Introduction and hypothesisIntravesical botulinum toxin A ( BTX-A ) is emerging as a potential new treatment for refractory interstitial cystitis ( IC ) . However , there has been conflicting evidence on this treatment 's effectiveness . The aim of our systematic review was to assess the effectiveness and adverse effects of intravesical BTX-A in IC . Methods R and omised controlled trials ( RCTs ) and prospect i ve studies of relevance were identified , assessed for inclusion and then analysed by two independent review ers . Results Ten ( three RCTs and seven prospect i ve cohort ) studies with a total of 260 participants were included . Eight studies reported improvement in symptoms . Urodynamic parameters were variable . Meta- analysis was not performed due to heterogeneity in reporting of outcomes . Some adverse events , e.g. dysuria and voiding difficulty , were noted ( 19 out of 260 were required to self-catheterise at anytime postoperatively ) . Conclusions The evidence from the studies thus far suggests a trend towards short-term benefit with intravesical BTX-A injections in refractory IC , but further robust evidence should be awaited
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"OBJECTIVES To present clinical evidence with botulinum toxin A ( BTX-A ) suggesting an antinociceptive role in patients with interstitial cystitis ( IC ) . Intriguing evidence in a somatic pain model has suggested that BTX-A injection may have an antinociceptive effect on both acute and chronic ( inflammatory ) pain . METHODS Thirteen female patients ( 6 in the United States and 7 in Pol and ) with IC according to the criteria of the National Institute of Diabetes , Digestive and Kidney Disease were included . Under short general anesthesia or sedation , 100 to 200 U of Dysport ( Polish patients ) or Botox ( U.S. patients ) was injected through a cystoscope into 20 to 30 sites submucosally in the trigone and floor of the bladder . Patients were evaluated with the O'Leary-Sant vali date d IC question naire or with voiding charts and a visual analog pain scale 1 month postoperatively and at subsequent 3-month intervals . The Polish patients also underwent pretreatment and post-treatment urodynamic evaluations . RESULTS Overall , 9 ( 69 % ) of 13 patients noted subjective improvement after BTX-A treatment . The Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index mean scores improved by 71 % and 69 % , respectively ( P Daytime frequency , nocturia , and pain by visual analog scale decreased by 44 % , 45 % , and 79 % , respectively ( P first desire to void and maximal cystometric capacity increased by 58 % and 57 % , respectively ( P BTX-A has an antinociceptive effect on bladder afferent pathways in patients with IC , producing both symptomatic and functional ( ie , urodynamic ) improvements",
"OBJECTIVES To investigate the level of nerve growth factor ( NGF ) mRNA in bladder tissue and the effect of botulinum toxin A ( BTX-A ) treatment in patients with interstitial cystitis ( IC ) . METHODS A total of 19 patients with IC were treated with 100 U or 200 U of intravesical BTX-A injections followed by cystoscopic hydrodistension 2 weeks later . Bladder mucosa biopsies were performed before BTX-A injection and immediately after hydrodilation and in 12 controls . The NGF mRNA and protein levels in bladder tissues were assessed by real-time polymerase chain reaction and immunohistochemistry studies to determine differences in NGF expression between patients with IC before and after BTX-A treatment and compare with controls . RESULTS At 3 months , 14 patients had symptomatic improvement ( responders ) and 5 did not ( nonresponders ) . The NGF mRNA levels at baseline in the overall IC patient group were significantly greater than those in the controls ( 0.65 + /- 0.33 versus 0.42 + /- 0.25 , P = 0.046 ) . At 2 weeks after BTX-A treatment , the NGF mRNA levels had decreased to 0.47 + /- 0.23 ( P = 0.002 , compared with baseline ) and were no longer significantly different from those of the controls . The NGF mRNA levels decreased significantly in responders and were significantly decreased after BTX-A in 11 patients with a visual analog pain scale reduction of 2 or more . The immunoreactivity study of bladder tissue from patients with IC showed greater NGF density at baseline compared with controls , but the difference was no longer significant after successful BTX-A treatment . CONCLUSIONS Intravesical BTX-A injections plus hydrodistension reduce bladder pain in patients with IC . The NGF levels in the bladder tissue were significantly increased in patients with IC and decreased to normal level after treatment in responders",
"PURPOSE We evaluated the 1-year efficacy and tolerability of botulinum A toxin intravesically injected in patients with painful bladder symptoms associated with increased urinary frequency , refractory to conventional treatments . MATERIAL S AND METHODS Three men and 12 women were prospect ively included in the study . Under short general anesthesia the patients were given injections of 200 U commercially available botulinum A toxin diluted in 20 ml 0.9 % NaCl . Injections were performed submucosally in the bladder trigone and lateral walls under cystoscopic guidance . A voiding chart and the visual analog scale for pain were used , and urodynamics were performed before treatment , and 1 , 3 , 5 and 12 months later . RESULTS Overall 13 patients ( 86.6 % ) reported subjective improvement at the 1 and 3-month followups . The mean visual analog scale score , and daytime and nighttime urinary frequency were significantly decreased ( p beneficial effects persisted in 26.6 % of cases but increased daytime and nighttime urinary frequency , and an increased visual analog scale score were observed compared to baseline . At 12 months after treatment pain recurred in all patients . Nine patients complained of dysuria 1 month after treatment . Dysuria persisted in 4 cases at the 3-month followup and in 2 at the 5-month followup . CONCLUSIONS Intravesically injected botulinum toxin A is effective for short-term management of refractory painful bladder syndrome . The beneficial effects decreased progressively within a few months after treatment . Thus , repeat injections of the neurotoxin are required for efficacious treatment in patients with the disease"
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41174696-06ff-11f0-808a-c43d1ab1c353
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The assessment of root canal curvature is essential for clinical and research purpose s. This systematic review presents an overview of the published techniques for the measurement of root canal curvature features using imaging and to provide a critique of their clinical application . A data base search in PubMed , PubMed Central , Embase , Scopus , EBSCO Dentistry & Oral Sciences Source and Virtual Health Library was conducted , using appropriate key words to identify measurement methods for root canal curvatures . The search strategy retrieved 10594 records in total , and 31 records fulfilled the inclusion criteria . From 2D image acquisitions , eleven studies measured exclusively the angle of curvature , an additional thirteen measured other curvature features ( level , height , radius , length and shape ) . Seven reports described methods from 3D imaging ( CBCT , μCT ) . Root canal curvatures should be measured , for clinical proposes , to facilitate endodontic treatment planning , and in research , to reduce the risk of selection bias . This review has revealed that there are many methods described in the literature ; however , no consensus exists on which method should be used . Some of the method ologies have potential clinical translation , whereas others are suitable for research purpose only , as they require a specific software or radiographic exposure in the mesiodistal direction
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"INTRODUCTION Nickel-titanium rotary instruments reduce procedural errors and the time required to finish root canal preparation . The goal of this study was to evaluate the effectiveness of a manual glide path on the preparation of curved root canals with Mtwo rotary system . METHODS Forty buccal root canals with angles of curvature between 25 to 76 degrees were r and omly divided into 4 groups ( n = 10 ) ; 2 groups were instrumented with Mtwo instruments to the full length , and in the other 2 groups a glide path with # 08 - 15 K files was performed before instrumentation with Mtwo system . Digital double radiographic technique was used to determine apical transportation and the change in angle of curvature . Also working time was calculated . RESULTS No statistically significant differences in the angle of canal curvature , apical transportation , and the working time were found between groups with glide path and no glide path . No significant differences were found when comparing the results of 3 variables between degrees of curvature . CONCLUSION The use of a manual glide path before Mtwo rotary system did not influence the apical transportation in curved root canals",
"The degree and configuration of canal curvature was studied in the mesial roots of 100 r and omly selected m and ibular first and second molars . The teeth were radiographed in buccolingual ( clinical ) and mesiodistal ( proximal ) directions with # 8 K files in place . One hundred percent of the specimens demonstrated curvature in both views . No correlation in degree of curvature was found to exist between the clinical and proximal views . Secondary curvature , in a direction opposite to that of the principle curve , was seen more frequently in the proximal view . In the proximal view , canals exhibited greater mean curvature than in the clinical view 38 % of the time . Weine type II morphology ( two canals , one foramen ) demonstrated the greatest range in canal curvature when viewed from the proximal . Coronal flaring with Canal Master rotary instruments to a level just coronal to the curve significantly reduced the severity of curvatures in both views for most cases",
"The aim of this paper is to present a new method based on numeric calculus to provide data on any type of root canal curvature at any point of the long axis of the canal . Twenty severely curved , simulated root canals were prepared with rotary FlexMaster and Profile instruments in the crown-down technique and manually in the step-back technique . The inner and outer curvatures were registered in a system of coordinates before and after preparation in increments of 0.5 mm . Using an equalising function , the curvatures were first represented in graphic and algebraic form . The maximum and the mean curvature as well as the length of the arc from the apical foramen to the point of maximum curvature were determined mathematically . An increase in maximum curvature was registered for all four shaping systems investigated . The radius of the inner curvature decreased by 0.5 - 1.2 mm in the manual systems as a result of the preparation . The Profile system displayed the smallest changes in radius ( -0.9 mm ) even with the outer curvature , and manual preparation with stainless steel files the most pronounced change ( -1.8 mm ) . The point of maximum curvature at the inner curvature was displaced by 1.6 mm to the apical foramen through manual preparation with Ni-Ti files . At the outer curvature , the maximum displacement ( 1.8 mm ) recorded was also the result of preparation with Ni-Ti h and files , while a displacement of only 0.3 mm to the apical foramen was recorded with the other systems . The method offers a means of determining curvatures precisely without r and om specification of reference points . The method is also capable of registering only minor changes in curvature in the two-dimensional long axis of the canal",
"INTRODUCTION X-ray computed micro-tomography scanning allows high-resolution 3-dimensional imaging of small objects . In this study , micro-CT scanning was used to compare the ability of manual and mechanical glide path to maintain the original root canal anatomy . METHODS Eight extracted upper first permanent molars were scanned at the TOMOLAB station at ELETTRA Synchrotron Light Laboratory in Trieste , Italy , with a microfocus cone-beam geometry system . A total of 2,400 projections on 360 ° have been acquired at 100 kV and 80 μA , with a focal spot size of 8 μm . Buccal root canals of each specimen ( n = 16 ) were r and omly assigned to PathFile ( P ) or stainless-steel K-file ( K ) to perform glide path at the full working length . Specimens were then microscanned at the apical level ( A ) and at the point of the maximum curvature level ( C ) for post-treatment analyses . Curvatures of root canals were classified as moderate ( ≤35 ° ) or severe ( ≥40 ° ) . The ratio of diameter ratios ( RDRs ) and the ratio of cross-sectional areas ( RAs ) were assessed . For each level of analysis ( A and C ) , 2 balanced 2-way factorial analyses of variance ( P significance of the instrument factor and of canal curvature factor as well as the interactions of the factors both with RDRs and RAs . RESULTS Specimens in the K group had a mean curvature of 35.4 ° ± 11.5 ° ; those in the P group had a curvature of 38 ° ± 9.9 ° . The instrument factor ( P and K ) was extremely significant ( P both the RDR and RA parameters , regardless of the point of analysis . CONCLUSIONS Micro-CT scanning confirmed that NiTi rotary PathFile instruments preserve the original canal anatomy and cause less canal aberrations",
"A new radiographic technique was used to compare apical transportation in four Ni-Ti rotary instrumentation sequences . Mesiobuccal canals of 60 extracted m and ibular molars were r and omly divided into four groups . Groups 1 and 3 were instrumented by crown-down and groups 2 and 4 by step-back technique with 0.06 ProFiles series 29 to size 6 . In groups 3 and 4 Greater Taper files were first used in a crown-down manner . The central axes of initial and final instruments were radiographically superimposed to measure loss of working length ( WL ) and transportation at 0 , 0.5 , 1 , 3 , and 5 mm from WL . ANOVA test showed no significant differences among groups regarding degree of transportation or loss of WL . Transportation was negatively correlated with radius of curvature at 0.5 and 5 mm from WL . The results indicate that the operational sequence of ProFiles or preinstrumentation with GT files has no effect on degree of transportation and loss of WL",
"The objective of this study was to evaluate the shaping characteristics of different root canal instruments in teeth with different root canal forms . A total of 420 extracted human roots were embedded in resin blocks . The embedded roots were divided into three groups , i.e. , roots with ( i ) straight ( I form ) , ( ii ) apically curved ( J form ) , and ( iii ) entirely curved canals ( C form ) with reference to the Schneider 's angle and the length of the radius of arc of the curvature of the root canals . Each of the three groups containing 140 roots were r and omly divided into seven subgroups prior to preparation . The canals were enlarged manually with traditional and flexible h and instruments , three different engine driven instruments and sonically and ultrasonically powered instruments . The shortcomings of the seven preparation methods were assessed by superimposition of projected radiographs taken in bucco-lingual and mesio-distal views before and after preparation . Results showed that observation of perforation , incidence of elbow and of asymmetrical preparation of the root canals depended on root canal configuration . It was striking that the coronal transposition of the apical stop , uneven wall contour , ledge formation and incidence of zip were independent of root canal morphology . Evaluation of data of asymmetry of preparation ( canal transposition ) revealed significant differences ( p Asymmetry of preparation was the most frequent aberration of the prepared root canals and it was possible to study it with precision . It was concluded that this measurement should be a priority for future instrument testing . The shaping characteristics of h and and engine driven instruments was modified by root canal morphology , but that of sonic and ultrasonic instruments was less dependent on the original anatomical form of root canals",
"The objective of this study was to evaluate the shaping characteristics of various root canal instruments using human teeth . A total of 420 extracted human roots were embedded in resin blocks . The embedded roots were divided into three groups , i.e. roots with ( i ) straight , ( ii ) apically curved , and ( iii ) whole-length curved canals according to the Schneider 's angle and the length of the radius of arc fitting the curvature of root canals . Each of the three groups containing 140 roots were r and omly divided into seven subgroups prior to preparation . The canals were prepared manually with traditional and flexible instruments , engine driven Racer-type , Giro-type , r and omly vibrating instruments and with sonic and ultrasonic instruments . The shortcomings of the seven preparation methods were assessed by the superimposition of projected radiographs taken in bucco-lingual and mesio-distal views before and after the preparation . The prepared straight canals showed a high percentage ( 75.7 % ) of apical asymmetry . Coronal transposition of the apical stop was grade d with higher scores in all canal forms prepared with Racer-type and Giro-type instruments , which could have occurred through packing of debris towards the apical constriction . The majority of the prepared curved canals were asymmetrical in shape . The location of the aberrations depended on the original shape of the canal but the method of shaping also had a decisive effect on the post-operative form of the canal . Large differences were found between the incidence of elbow ( 11.7 - 40.0 % ) and zip ( 75.7 - 80.0 % ) . K-Flex files produced minor canal aberrations and significantly less asymmetry ( P MM 1400 h and piece and ultrasonic instruments were associated with less aberration and significantly less asymmetry than the other instruments tested . The Excalibur appeared to be superior to the conventional h and instruments in straight canals , but its shaping characteristics were similar to conventional instruments in curved canals . Under the conditions of this study , canal shaping with Cavi Endo , MM 1400 and K-Flex files appeared to be superior to that achieved with conventional h and instruments Excalibur , Intra Lux Endo Kopf 3LDSY , and 3LD instruments",
" Canal curvatures of 700 permanent human teeth were determined by measuring the angle and the radius of the curvatures and the length of the curved part of the canal . For each type of tooth ( except third molars ) 50 were selected at r and om and were investigated . Size 08 silver points were inserted into the canals , and the teeth were radiographed from a facial and proximal view by using a st and ardized technique . All radiographs were analyzed by a computerized digital image processing system . Of the 1163 root canals examined , 980 ( 84 % ) were curved and 65 % showed an angle or = 27 degrees with radii angles between 27 degrees and 35 degrees with radii not greater than 15 mm , and 9 % of all canals that were investigated had curves > 35 degrees with the greatest radius of 13 mm . The greatest angle of all the teeth was 75 degrees with a radius of 2 mm . To define the canal curvature mathematically and unambiguously , the angle , the radius , and the length of the curve should be given",
"AIM The purpose of this study was to compare the shaping characteristics of Ni-Ti K-files and Ni-Ti S-files manipulated by h and . METHODOLOGY A total of 60 extracted human roots were embedded in resin blocks . The embedded roots were divided into three groups : ( i ) roots with straight ; ( ii ) apically curved ; and ( iii ) continuously curved canals . Each of the three groups was r and omly divided into two subgroups ; one subgroup in each group was prepared with Ni-Ti K-files and the other with Ni-Ti S-files . The files were used with a step-back technique and enlarged so that the master apical file was size 30 , and the canals were stepped back to size 40 . The performance of the files was assessed by the superimposition of projected radiographs taken in bucco-lingual and mesio-distal directions before and after the preparation . The results were analysed statistically using analysis of covariance and Duncan 's multiple range test . RESULTS Although canal preparation using Ni-Ti K-files was quicker , there were no statistically significant differences between file types . The Ni-Ti S-file removed significantly more material at the most coronal level ( P Ni-Ti S-files was significantly more dentine removed from the outer aspect of the curvature ( P Ni-Ti S-files removed more dentine from the inner aspect of the curvature in those roots with apically curved canals . CONCLUSIONS Under the conditions of this study , preparation with Ni-Ti K-files produced more appropriate shapes in roots with apically curved canals than Ni-Ti S-files",
"The purpose of this study was to compare three engine driven ( nickel-titanium ) NiTi instrument systems with h and files for their effect on canal transportation . Mesial roots of mature lower first molars with separate canals were paired on the basis of curvature and morphology . Canal lengths were st and ardized to 11 mm from orifice to apical foramen . Profile , Lightspeed , McXIM , and Flex-R h and filing techniques respectively were r and omly assigned to one of the four canals of each tooth pair . The roots were mounted and sectioned at 1 mm , 3 mm , and 5 mm from working length using a modified Bramante technique . All sections were video imaged preoperatively after instrumentation to size # 30 and after final instrumentation to size # 40 . The images were computer analyzed for changes in canal area and centering at each stage of instrumentation . Preparation time was also recorded . Data were analyzed using ANOVA . The NiTi systems remained better centered in the canal than stainless steel h and files . There were no significant differences among the NiTi systems at any level . The difference between h and filing and the NiTi techniques was more pronounced at size # 40 than at size # 30 . The NiTi systems were all significantly faster than h and filing . No significant differences in preparation were found between the NiTi systems when canals were instrumented to the size nearest # 40",
"Straightening of curved canals is one of the most common procedural errors in endodontic instrumentation . This problem is commonly encountered when dental students perform molar endodontics . The purpose of this study was to compare the effect of the type of instrument used by these students on the extent of straightening and on the incidence of other endodontic procedural errors . Nickel-titanium 0.02 taper h and files were compared with traditional stainless-steel 0.02 taper K-files . Sixty molar teeth comprised of maxillary and m and ibular first and second molars were treated by senior dental students . Instrumentation was with either nickel-titanium h and files or stainless-steel K-files . Preoperative and postoperative radiographs of each tooth were taken using an XCP precision instrument with a customized bite block to ensure accurate reproduction of radiographic angulation . The radiographs were scanned and the images stored as TIFF files . By superimposing tracings from the preoperative over the postoperative radiographs , the degree of deviation of the apical third of the root canal filling from the original canal was measured . The presence of other errors , such as strip perforation and instrument breakage , was established by examining the radiographs . In curved canals instrumented by stainless-steel K-files , the average deviation of the apical third of the canals was 14.44 degrees ( + /- 10.33 degrees ) . The deviation was significantly reduced when nickel-titanium h and files were used to an average of 4.39 degrees ( + /- 4.53 degrees ) . The incidence of other procedural errors was also significantly reduced by the use of nickel-titanium h and files"
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411746d2-06ff-11f0-808a-c43d1ab1c353
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Stroke has a devastating impact on individuals and families . Risk factors for recurrence include lifestyle behaviours such as smoking , excessive alcohol consumption , an unhealthy diet and physical inactivity . This article describes a programme of research that aims to gather and synthesis e the evidence required to inform the development and evaluation of a family centred , behavioural intervention design ed to address lifestyle risk factors for recurrent stroke . We present an overview of the research undertaken to develop the evidence base . This included a survey of stroke nurse practice , a focus group study with people who had had a stroke as well as their family members , and a systematic review of the efficacy of lifestyle interventions
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"Objective : To assess the rate , degree , and predictors of recovery from a disabled to nondisabled state in patients disabled after recurrent ischemic stroke . Methods : Patients with ischemic stroke enrolled in the Management of Atherothrombosis with Clopidogrel in High Risk Patients ( MATCH ) Study underwent prospect i ve assessment of their modified Rankin score ( mRS ) at 1 , 3 , 6 , 12 , and 18 months after enrollment and after recurrent stroke . Patients disabled ( defined as mRS ≥ 3 ) after recurrence were analyzed for recovery ( defined as mRS Three hundred forty-five ( 54 % ) of 637 patients were disabled after recurrent ischemic stroke ; 115 ( 33 % ) patients had been disabled and 230 ( 66 % ) nondisabled before stroke recurrence . At recurrence , the degree of disability was moderate ( mRS 3 ) in 135 ( 39 % ) patients , severe ( mRS 4 ) in 139 ( 40 % ) , and very severe ( mRS 5 ) in 71 ( 21 % ) . After 12 months ' median follow-up , 117 ( 34 % , 95 % CI : 29 to 39 % ) had recovered : 68 ( 50 % , 42 to 59 % ) of 135 moderately disabled , 45 ( 32 % , 25 to 41 % ) of 139 severely disabled , and 4 ( 6 % , 2 to 14 % ) of 71 very severely disabled ; 70 ( 20.3 % ) patients died . From recurrence , median time to recovery was 6 months ( mRS 3 ) and 18 months ( mRS 4 ) ; 94 % with very severe disability had not recovered at 18 months . Independent predictors of recovery were moderate disability at recurrence ( mRS 3 ) compared with severe ( mRS 4 : hazard ratio [ HR ] 1.5 ; 95 % CI 1.04 to 2.3 ) or very severe disability ( mRS 5 : HR 7.6 ; 2.7 to 20 ) and a nondisabled vs disabled state before recurrence ( HR 4.0 ; 2.3 to 6.8 ) . Conclusions : The rate of recovery from recurrent ischemic stroke was greatest in the first 6 months ; one-third of patients recovered within 12 months . The significant predictors of recovery were a nondisabled state before recurrence and increasing severity of the recurrent stroke",
"BACKGROUND Our aim was to investigate whether a nurse-coordinated multidisciplinary , family-based preventive cardiology programme could improve st and ards of preventive care in routine clinical practice . METHODS In a matched , cluster-r and omised , controlled trial in eight European countries , six pairs of hospitals and six pairs of general practice s were assigned to an intervention programme ( INT ) or usual care ( UC ) for patients with coronary heart disease or those at high risk of developing cardiovascular disease . The primary endpoints-measured at 1 year-were family-based lifestyle change ; management of blood pressure , lipids , and blood glucose to target concentrations ; and prescription of cardioprotective drugs . Analysis was by intention to treat . The trial is registered as IS RCT N 71715857 . FINDINGS 1589 and 1499 patients with coronary heart disease in hospitals and 1189 and 1128 at high risk were assigned to INT and UC , respectively . In patients with coronary heart disease who smoked in the month before the event , 136 ( 58 % ) in the INT and 154 ( 47 % ) in the UC groups did not smoke 1 year afterwards ( difference in change 10.4 % , 95 % CI -0.3 to 21.2 , p=0.06 ) . Reduced consumption of saturated fat ( 196 [ 55 % ] vs 168 [ 40 % ] ; 17.3 % , 6.4 to 28.2 , p=0.009 ) , and increased consumption of fruit and vegetables ( 680 [ 72 % ] vs 349 [ 35 % ] ; 37.3 % , 18.1 to 56.5 , p=0.004 ) , and oily fish ( 156 [ 17 % ] vs 81 [ 8 % ] ; 8.9 % , 0.3 to 17.5 , p=0.04 ) at 1 year were greatest in the INT group . High-risk individuals and partners showed changes only for fruit and vegetables ( p=0.005 ) . Blood-pressure target of less than 140/90 mm Hg was attained by both coronary ( 615 [ 65 % ] vs 547 [ 55 % ] ; 10.4 % , 0.6 to 20.2 , p=0.04 ) and high-risk ( 586 [ 58 % ] vs 407 [ 41 % ] ; 16.9 % , 2.0 to 31.8 , p=0.03 ) patients in the INT groups . Achievement of total cholesterol of less than 5 mmol/L did not differ between groups , but in high-risk patients the difference in change from baseline to 1 year was 12.7 % ( 2.4 to 23.0 , p=0.02 ) in favour of INT . In the hospital group , prescriptions for statins were higher in the INT group ( 810 [ 86 % ] vs 794 [ 80 % ] ; 6.0 % , -0.5 to 11.5 , p=0.04 ) . In general practice s in the intervention groups , angiotensin-converting enzyme inhibitors ( 297 [ 29 % ] INT vs 196 [ 20 % ] UC ; 8.5 % , 1.8 to 15.2 , p=0.02 ) and statins ( 381 [ 37 % ] INT vs 232 [ 22 % ] UC ; 14.6 % , 2.5 to 26.7 , p=0.03 ) were more frequently prescribed . INTERPRETATION To achieve the potential for cardiovascular prevention , we need local preventive cardiology programmes adapted to individual countries , which are accessible by all hospitals and general practice s caring for coronary and high-risk patients",
"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"
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41174718-06ff-11f0-808a-c43d1ab1c353
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We aim ed to investigate the potential association between vitamin D and serum leptin levels by pooling together the results from observational studies and clinical trials . A systematic literature search of PubMed , Scopus and Google Scholar was conducted up to March 2015 . The analysis of observational studies was conducted on six papers that reported nine correlation coefficients using Fisher ’s Z and its st and ard error . Then , effect sizes of eligible trials were pooled using r and om-effects models ( the DerSimonian-Laird estimator ) . Results of observational studies showed an inverse association between leptin and 25-hydroxyvitamin D ( 25(OH)D ) ( Fisher ’s Z=−0.93 , 95 % CI : −0.95 , −0.91 ) . After combining trials , pooled mean difference ( PMD ) for 25(OH)D was 24.06 ng/ml ( 95 % CI , 17.27–30.85 ; P increase in leptin level ( PMD=4.60 ng/ml , 95 % CI , 0.55–8.66 , P=0.026 ) with significant heterogeneity ( P Population with diabetes ( PMD : 13.63 ng/ml ) , age younger than 50 years ( PMD : 1.884 ng/ml ) , doses less than 1000 IU/day ( PMD : 1.53 ng/ml ) , duration less than 24 weeks ( PMD : 14.668 ng/ml ) and baseline 25(OH)D inverse association between leptin level and 25(OH)D concentration was observed in observational studies , which was not demonstrated in intervention studies with high heterogeneity . Clearly , there is a need for properly design ed and large prospect i ve dose – response trials with long-term follow-up to assess the sources of heterogeneity
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"Background Heart and coronary calcifications in hemodialysis patients are of very common occurrence and linked to cardiovascular events and mortality . Several studies have been published with similar results . Most of them were mainly cross-sectional and some of the prospect i ve protocol s were aim ed to evaluate the results of the control of altered biochemical parameters of mineral disturbances with special regard to serum calcium , phosphate and CaxP with the use of calcium containing and calcium free phosphate chelating agents . The aim of the present study was to evaluate in hemodialysis patients classic and some non classic risk factors as predictors of calcification changes after one year and to evaluate the impact of progression on survival . Methods 81 patients on hemodialysis were studied , with a wide age range and HD vintage . Several classic parameters and some less classic risk factors were studied like fetuin-A , CRP , 25-OHD and leptin . Calcifications , as Agatston scores , were evaluated with Multislice CT basally and after 12 - 18 months . Results Coronary artery calcifications were observed in 71 of 81 patients . Non parametric correlations between Agatston scores and Age , HD Age , PTH and CRP were significant . Delta increments of Agatston scores correlated also with serum calcium , CaxP , Fetuin-A , triglycerides and serum albumin . Logistic regression analysis showed Age , PTH and serum calcium as important predictors of Delta Agatston scores . LN transformation of the not normally distributed variables restricted the significant correlations to Age , BMI and CRP . Considering the Delta Agatston scores as dependent , significant predictors were Age , PTH and HDL . A strong association was found between basal calcification scores and Delta increment at one year . By logistic analysis , the one year increments in Agatston scores were found to be predictors of mortality . Diabetic and hypertensive patients have significantly higher Delta scores . Conclusions Progression of calcification is of common occurrence , with special regard to elevated basal scores , and is predictive of survival . Higher predictive value of survival is linked to the one year increment of calcification scores . Some classic and non classic risk factors play an important role in progression . Some of them could be controlled with appropriate management with possible improvement of mortality",
"Background It is undetermined whether calcium supplementation has an effect on obesity or body composition in postmenopausal women . The purpose of the study is to detect the effect of calcium supplementation on indices of obesity and body composition . Methods This is a secondary analysis of data from a population -based , double-blind , placebo-controlled , r and omized trial design ed to determine the effects of calcium and vitamin D on osteoporotic fractures . The cohort included 1179 postmenopausal women who were r and omly assigned into one of three groups : 1 ) supplemental calcium ( 1400 mg/d or 1500 mg/d ) plus vitamin D placebo ( Ca-only group ) ; 2 ) supplemental calcium ( 1400 mg/d or 1500 mg/d ) plus supplemental vitamin D3 ( 1100 IU/d ) ( Ca + D group ) ; or , 3 ) two placebos ( placebo group ) . After applying the exclusion criteria for this analysis , 870 subjects were included in this study . The primary outcomes for the present study were changes in body mass index , trunk fat , trunk lean , and percentage of trunk fat after calcium supplementation . Results Changes in trunk fat , trunk lean , and percentage of trunk fat were significantly different between the calcium intervention groups ( Ca-only group or Ca + D group ) and the placebo group during the trial ( P calcium intervention groups gained less trunk fat and maintained more trunk lean when compared to the placebo group . No significant difference was observed for body mass index between groups . Conclusion Calcium supplementation over four years has a beneficial effect on body composition in postmenopausal women",
"OBJECTIVE The aim of this study was to explore the effects of cholecalciferol supplementation on vitamin D levels , bone mineral density ( BMD ) , body fat distribution and insulin sensitivity in vitamin D-deficient HIV-1-infected patients . METHODS Twenty vitamin D-deficient HIV-1-infected patients were prospect ively treated with 2000 IU cholecalciferol/day for 14 weeks , whereafter treatment was continued with half this dosage until 48 weeks . BMD , body fat distribution , 1,25-dihydroxy vitamin D(3 ) ( 1,25(OH)2D3 ) , fasting glucose , insulin , adiponectin , leptin , interleukin (IL)-6 and tumour necrosis factor (TNF)-alpha were measured at baseline , and at 24 and 48 weeks . Parathyroid hormone ( PTH ) , 25-hydroxy vitamin D(3 ) [ 25(OH)D(3 ) ] , cholesterol and triglycerides were measured at baseline , and at 12 , 24 and 48 weeks . RESULTS After 24 weeks , cholecalciferol supplementation significantly increased 25(OH)D3 and 1,25(OH)2D3 levels and decreased PTH and insulin sensitivity . After 48 weeks , however , only 25(OH)D3 levels remained significantly different from baseline , while the other parameter levels returned to baseline , suggesting a dose-response effect . Cholecalciferol had no effect on BMD , adipokines and triglycerides . CONCLUSIONS The effect of cholecalciferol treatment in this cohort appears to be dose dependent . Cholecalciferol dosages of > or = 2000 IU are necessary to achieve 1,25(OH)2D3 levels that significantly decrease PTH , but also negatively affect insulin sensitivity . The results of this hypothesis-driven explorative study need to be confirmed in larger clinical trials",
"Aim /hypothesisLeptin has been shown to regulate angiogenesis in animal and in vitro studies by upregulating the production of several pro-angiogenic factors , but its role in regulating angiogenesis has never been studied in humans . Methods The potential angiogenic effect of two doses of metreleptin ( 50 and 100 ng/ml ) was evaluated in vitro , using a novel three-dimensional angiogenesis assay . Fifteen healthy , normoleptinaemic volunteers were administered both a physiological ( 0.1 mg/kg ) and a pharmacological ( 0.3 mg/kg ) single dose of metreleptin , in vivo , on two different inpatient admissions separated by 1–12 weeks . Serum was collected at 0 , 6 , 12 and 24 h after metreleptin administration . Twenty lean women , with leptin levels , were r and omised in a 1:1 fashion to receive either physiological replacement doses of metreleptin ( 0.04–0.12 mg/kg q.d . ) or placebo for 32 weeks . Serum was collected at 0 , 8 , 20 and 32 weeks after r and omisation . Proteomic angiogenesis array analysis was performed to screen for angiogenic factors . Circulating concentrations of angiogenin , angiopoietin-1 , platelet derived endothelial factor (PDGF)-AA , matrix metalloproteinase ( MMP ) 8 and 9 , endothelial growth factor ( EGF ) and vascular EGF ( VEGF ) were also measured . Results Both metreleptin doses failed to induce angiogenesis in the in vitro model . Although leptin levels increased significantly in response to both short-term and long-term metreleptin administration , circulating concentrations of angiogenesis markers did not change significantly in vivo . Conclusions /interpretationsThis is the first study that examines the effect of metreleptin administration in angiogenesis in humans . Metreleptin administration does not regulate circulating angiogenesis related factors in humans . Clinical trial registration : Clinical Trials.gov NCT00140205 and NCT00130117 . Funding : This study was supported by National Institutes of Health-National Center for Research Re sources grant M01-RR-01032 ( Harvard Clinical and Translational Science Center ) and grant number UL1 RR025758 . Funding was also received from the National Institute of Diabetes and Digestive and Kidney Diseases grants 58785 , 79929 and 81913 , and AG032030",
"There is increasing epidemiological evidence linking sub-optimal vitamin D status with overweight and obesity . Although increasing BMI and adiposity have also been negatively associated with the change in vitamin D status following supplementation , results have been equivocal . The aim of this r and omised , placebo-controlled study was to investigate the associations between anthropometric measures of adiposity and the wintertime serum 25-hydroxycholecalciferol ( 25(OH)D ) response to 15 μg cholecalciferol per d in healthy young and older Irish adults . A total of 110 young adults ( 20 - 40 years ) and 102 older adults ( ≥ 64 years ) completed the 22-week intervention with > 85 % compliance . The change in 25(OH)D from baseline was calculated . Anthropometric measures of adiposity taken at baseline included height , weight and waist circumference ( WC ) , along with skinfold thickness measurements to estimate fat mass ( FM ) . FM was subsequently expressed as FM ( kg ) , FM ( % ) , FM index ( FMI ( FM kg/height m2 ) ) and as a percentage ratio to fat-free mass ( FFM ) . In older adults , vitamin D status was inversely associated with BMI ( kg/m2 ) , WC ( cm ) , FM ( kg and % ) , FMI ( kg/m2 ) and FM : FFM ( % ) at baseline ( r - 0·33 , - 0·36 , - 0·33 , - 0·30 , - 0·33 and - 0·27 , respectively , all P values BMI in older adults was also negatively associated with the change in 25(OH)D following supplementation ( β - 1·27 , CI - 2·37 , - 0·16 , P = 0·026 ) ; however , no such associations were apparent in younger adults . Results suggest that adiposity may need to be taken into account when determining an adequate wintertime dietary vitamin D intake for healthy older adults residing at higher latitudes",
"Observational studies have suggested that 25-hydroxyvitamin D ( 25(OH)D ) levels are associated with inflammatory markers . Most trials reporting significant associations between vitamin D intake and inflammatory markers used specific patient groups . Thus , we aim ed to determine the effect of supplementary vitamin D using secondary data from a population -based , r and omised , placebo-controlled , double-blind trial ( Pilot D-Health trial 2010/0423 ) . Participants were 60- to 84-year-old residents of one of the four eastern states of Australia . They were r and omly selected from the electoral roll and were r and omised to one of three trial arms : placebo ( n 214 ) , 750 μg ( n 215 ) or 1500 μg ( n 215 ) vitamin D3 , each taken once per month for 12 months . Post-intervention blood sample s for the analysis of C-reactive protein ( CRP ) , IL-6 , IL-10 , leptin and adiponectin levels were available for 613 participants . Associations between intervention group and biomarker levels were evaluated using quantile regression . There were no statistically significant differences in distributions of CRP , leptin , adiponectin , leptin : adiponectin ratio or IL-10 levels between the placebo group and either supplemented group . The 75th percentile IL-6 level was 2·8 pg/ml higher ( 95 % CI 0·4 , 5·8 pg/ml ) in the 1500 μg group than in the placebo group ( 75th percentiles:11·0 v. 8·2 pg/ml ) , with a somewhat smaller , non-significant difference in 75th percentiles between the 750 μg and placebo groups . Despite large differences in serum 25(OH)D levels between the three groups after 12 months of supplementation , we found little evidence of an effect of vitamin D supplementation on cytokine or adipokine levels , with the possible exception of IL-6",
"The aim of this study was to assess the effects of single oral bolus of 300,000 IU Vitamin D3 on serum levels and on bone and metabolic parameters in diabetic patients . This study is a Phase IV , r and omized , double-blind , placebo-controlled , monocenter clinical trial . Thirty patients , 60 years or older , with type 2 diabetes mellitus , and diabetic foot complications , were enrolled and monitored for 24 weeks : 14 were treated with Vitamin D3 and 16 with placebo . Parameters including glucose , adiponectin , leptin , osteoprotegerin ( OPG ) , 25-hydroxyvitamin D [ 25(OH)D ] , beta-CrossLaps , osteocalcin , bone-specific isoenzyme of alkaline phosphatase , tumor necrosis factor-α and parathyroid hormone were measured at screening and baseline and 12 and 24 weeks after treatment . Analysis of covariance was used to compare treatment groups . Analysis of the data detected a significant increase in 25(OH)D serum levels both at 12 and 24 weeks with respect to baseline values only in the treated patients . Significant variations with respect to baseline values were noted in OPG ( P = 0.0085 ) and in leptin ( P = 0.0442 ) levels : these were lower in the placebo group at week 24 but higher in the treated group . Vitamin D3 supplementation significantly increased serum leptin and OPG levels . Further , large-scale clinical trials are warranted to confirm these results",
"CONTEXT To the best of our knowledge , no study has examined the effects of vitamin D-calcium cosupplementation on inflammatory biomarkers and adipocytokines in vitamin D-insufficient type 2 diabetics . OBJECTIVE This study was performed to assess the effects of vitamin D and calcium supplementation on inflammatory biomarkers and adipocytokines in vitamin D-insufficient people with type 2 diabetes . METHODS Totally , 118 diabetic patients were enrolled in this r and omized , placebo-controlled clinical trial . After matching for age , sex , body mass index , type and dose of hypoglycemic agents , and duration of diabetes , subjects were r and omly assigned into 4 groups receiving the following : 1 ) 50000 IU/wk vitamin D + calcium placebo ; 2 ) 1000 mg/d calcium + vitamin D placebo ; 3 ) 50 000 IU/wk vitamin D + 1000 mg/d calcium ; or 4 ) vitamin D placebo + calcium placebo for 8 weeks . Blood sampling was done for the quantification of inflammatory biomarkers and adipocytokines at the study baseline and after 8 weeks of intervention . RESULTS Calcium ( changes from baseline : -75 ± 19 ng/ml , P = .01 ) and vitamin D alone ( -56 ± 19 ng/mL , P = .01 ) and joint calcium-vitamin D supplementation ( -92 ± 19 ng/mL , P = .01 ) result ed in a significant reduction in serum leptin levels compared with placebo ( -9 ± 18 ng/mL ) . This was also the case for serum IL-6 , such that calcium ( -2 ± 1 pg/mL , P and vitamin D alone ( -4 ± 1 pg/mL , P the calcium ( -3.1 ± 1.3 , P , vitamin D ( -3.1 ± 1.3 , P joint calcium-vitamin D groups ( -3.4 ± 1.3 , P reductions in serum TNF-α concentrations compared with placebo ( 0.1 ± 1.2 ) . Individuals who received joint calcium-vitamin D supplements tended to have a decrease in serum high-sensitivity C-reactive protein levels compared with placebo after controlling for baseline levels ( -1.14 ± 0.25 vs 0.02 ± 0.24 ng/mL , P = .09 ) . CONCLUSION Joint calcium-vitamin D supplementation might improve systemic inflammation through decreasing IL-6 and TNF-α concentrations in vitamin D-insufficient people with type 2 diabetes",
"Background : Since tumor necrosis factor-α ( TNF-α ) could be one of the risk factors at the development of diabetes complications ; as well as serum leptin deficiency is related to increased susceptibility to infections in diabetic patients , they are potential indices from the preventive medicine viewpoint . This study was conducted to represent the effect of supplemental vitamin D3 on serum leptin , TNF-α and adiposity in type 2 diabetic patients . Methods : In this r and omized double-blind placebo-controlled trial , study sample was selected through type 2 diabetic patients ( n = 51 ) . A total of 26 patients were orally supplemented by vitamin D3 ( 400 IU/d ) ( vitamin D group ) and 25 patients by placebo ( placebo group ) for 14 weeks . The blood glycated hemoglobin ( HbA1c ) and the serum ionized Ca , leptin , TNF-α , and serum 25-hydroxyvitamin D ( 25[OH ] D ) were measured at the two groups in the baseline and postintervention stages . Results : It was shown that despite of theplacebo group , serum 25(OH ) D and serum leptin was significantly increased ( P = 0.001 and P = 0.002 , respectively ) , while serum TNF-α was decreased significantly ( P = 0.001 ) in vitamin D group . The remaining parameters , including body fat mass and HbA1c had no alterations between baseline and postintervention stages in vitamin D group . Conclusions : This study may advocate vitamin D supplementation among type 2 diabetic patients due to its beneficial effects on prevention of diabetes complications",
"OBJECTIVES Osteocalcin , a small peptide secreted by osteoblasts , has been recently described as a circulating hormone involved in the regulation of energy metabolism . In addition , experimental data suggest a regulation of adipocytes by bone , with a stimulation of adiponectin synthesis by osteocalcin and an inverse relationship between serum adiponectin level and bone mineral density ( BMD ) . However , this relationship has not been explored during chronic kidney disease ( CKD ) . METHODS Osteocalcin , adiponectin and leptin were prospect ively measured in a cohort of 61 CKD patients . A new non-invasive 3D bone imaging technique was performed ( high-resolution peripheral quantitative computed tomography , HR-pQCT ) , measuring volumetric BMD ( vBMD ) and microarchitecture parameters at the distal tibia . RESULTS Patients ' mean age was 67.2 + /- 13.9 years and mean GFR 33 + /- 12 mL/min/1.73 m(2 ) . We found a positive association between serum osteocalcin and adiponectin ( r = 0.29 , P = 0.021 ) . Univariate analysis showed inverse correlations between serum adiponectin and total vBMD ( r = -0.33 , P = 0.01 ) , cortical thickness ( r = -0.34 , P = 0.008 ) and trabecular vBMD ( r = -0.27 , P = 0.04 ) . These associations remained significant in multivariate analysis between serum adiponectin and total vBMD , cortical vBMD and cortical thickness . CONCLUSION We report for the first time an inverse relationship between bone density and adiponectin , as well as a positive association between osteocalcin and adiponectin in CKD II-IV patients",
"BACKGROUND & AIMS Vitamin D supplementation has the potential to alleviate the cardiovascular damage in diabetic patients . The present study was design ed to evaluate long term impact of high doses of vitamin D on arterial properties , glucose homeostasis , adiponectin and leptin in patients with type 2 diabetes mellitus . METHODS AND RESULTS In r and omized , placebo-controlled study 47 diabetic patients were assigned into two groups : Group 1 received oral daily supplementation with vitamin D at a dose of 1000 U/day for 12 months . Group 2 received matching placebo capsules . Blood sampling for metabolic parameters , including fasting glucose , lipid profile , HbA1C , insulin , hs-CRP , 25 OH Vit D , adiponectin and leptin was performed at baseline and at the end of the study . Insulin resistance was assessed by homeostasis model assessment ( HOMA-IR ) . Central aortic augmentation index ( AI ) was evaluated using SphygmoCor . RESULTS The two groups were similar at baseline in terms of hemodynamic parameters . After 12 months , AI decreased significantly during the treatment period in patients received vitamin D ( p Glucose homeostasis parameters , leptin as well as leptin adiponectin ratio did not change in both groups . 25 OH Vit D level significantly increased ( p = 0.022 ) and circulating adiponectin marginally increased ( p = 0.065 ) during 12 month treatment period in active treatment and did not change in placebo group . CONCLUSIONS High doses of vitamin D supplementation in diabetic patients was associated with significant decrease in AI during one year treatment . This beneficial vascular effect was not associated with improvement in glucose homeostasis parameters",
"AIMS To test whether a single large dose of vitamin D2 can improve endothelial function in patients with Type 2 diabetes mellitus and low serum 25-hydroxyvitamin D levels . METHODS Double-blind , parallel group , placebo-controlled r and omized trial . A single dose of 100,000 IU vitamin D2 or placebo was administered to patients with Type 2 diabetes over the winter , when levels of circulating 25-hydroxyvitamin D were likely to be lowest . Patients were enrolled if their baseline 25-hydroxyvitamin D level was Endothelial function and blood pressure were measured and fasting blood sample s were taken at baseline and 8 weeks after administration of vitamin D. RESULTS Forty-nine per cent of subjects screened had 25-hydroxyvitamin D levels Vitamin D supplementation increased 25-hydroxyvitamin D levels by 15.3 nmol/l relative to placebo and significantly improved flow mediated vasodilatation ( FMD ) of the brachial artery by 2.3 % . The improvement in FMD remained significant after adjusting for changes in blood pressure . Vitamin D supplementation significantly decreased systolic blood pressure by 14 mmHg compared with placebo ; this did not correlate with change in FMD . CONCLUSIONS Vitamin D insufficiency is common in patients with Type 2 diabetes during winter in Scotl and . A single large dose of oral vitamin D2 improves endothelial function in patients with Type 2 diabetes and vitamin D insufficiency",
"Purpose The serum 25-hydroxyvitamin D ( 25(OH)D ) levels are lower in obese than lean subjects . The present study examines the cross-sectional and longitudinal relations between body mass index ( BMI ) and serum 25(OH)D , and the serum 25(OH)D response to vitamin D supplementation in relation to BMI . Methods The Tromsø study is a longitudinal population -based multi purpose study . The fourth survey was conducted in 1994 and the sixth in 2008 . The intervention study was a 1-year placebo-controlled r and omized intervention trial , where the results from the 93 subjects given 40,000 IU per week are presented . Results A total of 10,229 subjects were included in the 2008 cross-sectional study . There was a significant negative association between serum 25(OH)D levels and BMI which was also present during the winter months . Serum 25(OH)D levels varied through seasons , but not BMI . In the longitudinal study from 1994 to 2008 which included 2,656 subjects , change in BMI was a significant negative predictor of change in 25(OH)D. In the intervention study , there was a significant and negative correlation between BMI and serum 25(OH)D both at baseline and at the end of the study . The increase in serum 25(OH)D after 1 year was significantly and inversely related to baseline BMI . Conclusions We have confirmed the strong association between serum 25(OH)D and BMI . The very obese need higher vitamin D doses than lean subjects to achieve the same serum 25(OH)D levels",
"CONTEXT Vitamin D receptors are present in many tissues . Hypovitaminosis D is considered to be a risk factor for atherosclerosis . OBJECTIVE This study explores the effects of vitamin D replacement on insulin sensitivity , endothelial function , inflammation , oxidative stress , and leptin in vitamin D-deficient subjects . DESIGN , SETTING , AND PATIENTS Twenty-three asymptomatic vitamin D-deficient subjects with 25-hydroxyvitamin D [ 25(OH)D ] levels below 25 nmol/liter were compared with a control group that had a mean 25(OH)D level of 75 nmol/liter . The vitamin D-deficient group received 300,000 IU i m monthly for 3 months . The following parameters were evaluated before and after treatment : vitamin D metabolites , leptin , endothelial function by brachial artery flow mediated dilatation ( FMD ) , insulin sensitivity index based on oral glucose tolerance test , and lipid peroxidation as measures of thiobarbituric acid reactive substances ( TBARS ) . RESULTS FMD measurements were significantly lower in 25(OH)D-deficient subjects than controls ( P = 0.001 ) and improved after replacement therapy ( P = 0.002 ) . Posttreatment values of TBARS were significantly lower than pretreatment levels ( P FMD and 25(OH)D ( r = 0.45 ; P = 0.001 ) and a negative correlation between FMD and TBARS ( r = -0.28 ; P leptin levels after therapy , and the leptin levels were positively correlated with 25(OH)D levels ( r = 0.45 ; P vitamin D has favorable effects on endothelial function . Vitamin D deficiency can be seen as an independent risk factor of atherosclerosis . Hypovitaminosis D-associated endothelial dysfunction may predispose to higher rates of cardiovascular disease in the winter",
"Background : Prolactin-raising antipsychotics , risperidone ( antidopaminergic activity ) , may be associated with low bone mass . On the other h and , risperidone may cause an increase in body weight thought to be favorable for bone . Objectives : ( 1 ) To determine bone remodeling parameters and bone mass in patients with schizophrenia on long-term treatment with long-acting injectable risperidone ( LAIR ) in naturalistic setting s , and ( 2 ) to evaluate the change in body weight , metabolic profile and neuroendocrine status in these patients . Design : This was a prospect i ve , cross-sectional study . Patients : Patients included 26 out patients with controlled schizophrenia in real-life conditions ( age 31.3 ± 1.3 years , BMI 28.1 ± 1.0 ) on long-term maintenance therapy with LAIR for a mean of 18.0 ± 1.6 months ( range 6–36 ) with a mean dose of 38 ± 2 mg . 35 subjects matched for sex , age , BMI and education served as healthy controls . Methods : Serum osteocalcin , C-terminal telopeptide of type I collagen ( CTx ) , vitamin D , leptin , prolactin , sex steroids , and parathyroid hormone were assessed . Indices of insulin sensitivity and resistance were determined following an oral glucose tolerance test ( OGTT ) . Bone mineral density ( BMD ) was measured by dual X-ray absorptiometry at the lumbar spine ( LS ) and femoral neck ( FN ) . Results : Mild to moderate hyperprolactinemia ( 1,000–2,000 mU/l ) was associated with asymptomatic hypogonadism . Prolactin values > 2,000 mU/l occurred in a few female patients . Hypogonadism leads to a slight increase ( upper limit of normal ) in bone resorption marker ( CTx ) in patients with schizophrenia ( p = 0.023 ) . As for bone mass , although lower at the spine than in healthy subjects , it did not reach statistical significance ( p = 0.094 ) , while at the FN , BMD was not different from healthy subjects . Body weight increased on average 8.7 ± 1.6 kg in more than 50 % of patients . Leptin levels adjusted for BMI in females were significantly higher in patients than in healthy female subjects ( p = 0.018 ) , while in males there was no difference between the groups ( p = 0.833 ) . A high prevalence of low vitamin D levels and more current smokers were found in patients with schizophrenia . As for the metabolic profile during treatment with risperidone , the low Matsuda index of insulin sensitivity ( p = 0.039 ) confirmed insulin resistance in these patients . Conclusion : A potential long-term consequence of asymptomatic hypogonadism due to risperidone-induced hyperprolactinemia might cause a slight rise in bone resorption marker ( CTx ) . On the other h and , by increasing body weight , risperidone could have a protective effect on the bone and thus no change in bone mass was recorded when compared with healthy controls"
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41174754-06ff-11f0-808a-c43d1ab1c353
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Background Vitamin D is essential for maintaining optimal bone health . The prevalence of vitamin D inadequacy in athletes is currently unclear . Objective The objective of this study is to determine the prevalence of vitamin D inadequacy in athletes . Methods We conducted a systematic review and meta- analysis . Multiple data bases were search ed and studies assessing serum 25-hydroxyvitamin D [ 25(OH)D ] status in athletes were identified . Serum 25(OH)D is measured to clinical ly determine vitamin D status . Review ers independently selected the eligible articles , assessed the method ological quality , and extracted data . Disagreements were resolved by consensus . Weighted proportions of vitamin D inadequacy [ serum 25(OH)D Twenty-three studies with 2,313 athletes [ mean ( st and ard deviation ) age 22.5 ( 5.0 ) years , 76 % male ] were included . Of 2,313 athletes , 56 % ( 44–67 % ) had vitamin D inadequacy that significantly varied by geographical location ( p UK and in the Middle East . The risk significantly increased for winter and spring seasons ( RR 1.85 ; 95 % CI 1.27–2.70 ) , indoor sport activities ( RR 1.19 ; 95 % CI 1.09–1.30 ) , and mixed sport activities ( RR 2.54 ; 95 % CI 1.03–6.26 ) . The risk was slightly higher for > 40 ° N latitude [ RR 1.14 ( 95 % CI 0.91–1.44 ) ] but it increased significantly [ RR 1.85 ( 1.35–2.53 ) ] after excluding the Middle East as an outlier . Seven studies with 359 athletes reported injuries . The prevalence of injuries in athletes was 43 % ( 95 % CI 20–68 ) [ bone related = 19 % ( 95 % CI 7–36 ) ; muscle and soft-tissue = 37.5 % ( 95 % CI 11.5–68.5 ) ] . Conclusion Despite the limitations of the current evidence , the prevalence of vitamin D inadequacy in athletes is prominent . The risk significantly increases in higher latitudes , in winter and early spring seasons , and for indoor sport activities . Regular investigation of vitamin D status using reliable assays and supplementation is essential to ensure healthy athletes . The prevalence of injuries in athletes is notable but its association with vitamin D status is unclear . A well- design ed longitudinal study is needed to answer this possible association
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"Objectives : To study the prevalence of hypovitaminosis D , the effect of vitamin D supplementation on serum 25-hydroxyvitamin D [ S-25(OH)D ] , and the intakes of vitamin D and calcium in Finnish 9− to 15-year-old athletic and nonathletic girls . Design : 1-year follow-up study ( February 1997-March 1998 ) with three months of vitamin D supplementation ( 10 μg/d ) from October to January . Setting : Turku University Central Hospital , Finl and .Subjects : 191 female volunteers aged 9–15 y ( 131 athletes and 60 controls ) . Methods : Vitamin D and calcium intakes were estimated by a four-day food recording and a semi-quantitative food frequency question naire ( FFQ ) . S-25(OH)D was followed by radioimmunoassay ( RIA ) . Results : At baseline the mean S-25(OH)D concentration was 33.9 nmol/l among all girls . In winter severe hypovitaminosis D ( S-25(OH)D occurred in 13.4 % of the participants and in 67.7 % S-25(OH)D was below 37.5 nmol/l . By the next summer the mean S-25(OH)D concentration was 62.9 nmol/l and in 1.6 % of the subjects it was below 37.5 nmol/l . The prevalence of severe hypovitaminosis D was not significantly reduced by three months of vitamin D ( 10 μg/d ) supplementation . At baseline , the mean intake of vitamin D was 2.9 μg/d by food recording and 4.3 μg/d by FFQ . The mean calcium intake was 1256 mg/d and 1580 mg/d , respectively . The intakes of vitamin D and calcium remained unchanged during the follow-up period . The athletes consumed more calcium than nonathletic controls , whereas the intake of vitamin D was quite similar among both groups . The vitamin D intake by FFQ correlated with the S-25(OH)D concentration in wintertime ( r=0.28 , P Finnish girls in the wintertime , and three months of vitamin D supplementation with 10 μg/d was insufficient in preventing hypovitaminosis D. The daily dietary vitamin D intake was insufficient ( < 5 μg/d ) in the majority of participants , while the calcium intake was usually sufficient . Sponsorship : Supported by the Yrjö Jahnsson Foundation , The Turku University Foundation , and the Medical Research Foundation of the Turku University Central Hospital",
"BACKGROUND Hypovitaminosis D is common worldwide , even in sunny regions . OBJECTIVES To assess the prevalence and determinants of vitamin D deficiency in toddlers . METHODS A cross-sectional prospect i ve study was conducted in healthy Jewish children aged 1.5 - 6 years at five primary care pediatric clinics in the Jerusalem area during the period October 2009 to November 2010 . Parents were interviewed regarding personal and demographic data and sun exposure . Blood sample s were obtained for serum 25-hydroxyvitamin D [ 25-OHD ] level . Vitamin D deficiency and insufficiency were defined as 25-OHD 247 children studied , 188 ( 76 % ) were ultra-Orthodox and 59 ( 24 % ) were Orthodox , traditional or secular . Mean ( + /- SD ) 25-OHD level was 25.7 + /- 10 ng/ml . Only 73 children ( 29.6 % ) had sufficient 25-OHD levels , 104 ( 42.1 % ) had insufficiency , and 70 ( 28.3 % ) had 25-OHD deficiency . The difference between ultra-Orthodox and others was insignificant ( 25 + /- 10 vs. 27.8 + /- 10.5 ng/ml respectively , P = 0.062 ) . Children aged 1.5 - 3 years had higher 25-OHD levels than those aged 3 - 6 years ( 28.6 + /- 10.7 and 24 + /- 9.2 ng/ml respectively , P Vitamin D deficiency was more common in winter ( 53 % ) and autumn ( 360 % ) than in summer ( 19 % ) and spring ( 16 % ) . Toddlers attending long-day kindergartens had higher 25-OHD level than those staying at home or at short-day kindergartens ( 28.8 + /- 11.5 and 24.7 + /- 9.6 ng/ml respectively , P toddlers in our study , mainly in older children and in the winter and autumn . We recommend routine supplementation of vitamin D for children beyond the age of one year",
"UNLABELLED Low vitamin D level may predict rickets , osteomalacia , or osteoporosis . We examined serum 25(OH)D concentration as a predisposing factor for bone stress fracture in 756 military recruits . The average serum 25(OH)D concentration was significantly lower in the group with fracture , suggesting a relationship between vitamin D and fatigue bone stress fracture . INTRODUCTION Low vitamin D level may predict rickets , osteomalacia , or osteoporosis . Fatigue bone stress fracture is one of the most frequently seen types of overuse injuries in athletes and military recruits . An association was recently shown between vitamin D and BMC . A correlation has also been found between low femoral BMD and stress fractures . We measured serum 25(OH)D concentration in a population sample of military recruits to determine if vitamin D is a predisposing factor for fatigue bone stress fracture . MATERIAL S AND METHODS We prospect ively followed 800 r and omly selected , healthy Finnish military recruits with a mean age of 19 years for developing stress fractures in homogenous circumstances . Blood for serum 25(OH)D concentration was drawn at entry into military service , and the weight , height , body mass index ( BMI ) , muscle strength , and 12-minute running were measured for all subjects . Serum 25(OH)D concentrations were measured with enzyme immunoassay . At end of the 90-day follow-up , 756 subjects completed the study . Subjects without fracture constituted controls . RESULTS Twenty-two recruits with stress fracture were identified ( 2.9 % ) , the incidence being 11.6 ( 95 % CI : 6.8 - 16.5 ) per 100 person-years . In the final multivariate analysis , the significant risk factor for stress fracture in conscripts was a below median serum 25(OH)D level ( 75.8 nM ) , OR being 3.6 ( 95 % CI : 1.2 - 11.1 ) . No significant associations between BMI ( p = 0.255 ) , age ( p = 0.216 ) , or smoking ( p = 0.851 ) and bone stress fracture were found in this study population . CONCLUSIONS A lower level of serum 25(OH)D concentration may be a generally predisposing element for bone stress fractures . Considering the obvious need of additional vitamin D in prevention of stress fractures , the effects of vitamin D fortification of foods and supplementation will be subjects of interest for future research",
"The purpose of this 6-month r and omized , placebo-controlled trial was to determine the effect of season-long ( September-March ) vitamin D supplementation on changes in vitamin D status , which is measured as 25(OH ) D , body composition , inflammation , and frequency of illness and injury . Forty-five male and female athletes were r and omized to 4,000 IU vitamin D ( n = 23 ) or placebo ( n = 22 ) . Bone turnover markers ( NTx and BSAP ) , 25(OH)D , and inflammatory cytokines ( TNF-alpha , IL-6 , and IL1-β ) were measured at baseline , midpoint , and endpoint . Body composition was assessed by DXA and injury and illness data were collected . All athletes had sufficient 25(OH)D ( > 32 ng/ml ) at baseline ( mean : 57 ng/ml ) . At midpoint and endpoint , 13 % and 16 % of the total sample had 25(OH)D respectively . 25(OH)D was not positively correlated with bone mineral density ( BMD ) in the total body , proximal dual femur , or lumbar spine . In men , total body ( p = .04 ) and trunk ( p = .04 ) mineral-free lean mass ( MFL ) were positively correlated with 25(OH)D. In women , right femoral neck BMD ( p = .02 ) was positively correlated with 25(OH)D. 25(OH)D did not correlate with changes in bone turnover markers or inflammatory cytokines . Illness ( n = 1 ) and injury ( n = 13 ) were not related to 25(OH)D ; however , 77 % of injuries coincided with decreases in 25(OH)D. Our data suggests that 4,000 IU vitamin D supplementation is an inexpensive intervention that effectively increased 25(OH)D , which was positively correlated to bone measures in the proximal dual femur and MFL . Future studies with larger sample sizes and improved supplement compliance are needed to exp and our underst and ing of the effects of vitamin D supplementation in athletes",
"Background Vitamin D deficiency is common in the general public and athletic population s and may impair skeletal muscle function . We therefore assessed the effects of vitamin D3 supplementation on serum 25[OH]D concentrations and physical performance . Methods 30 club-level athletes were block r and omised ( using baseline 25[OH]D concentrations ) into one of three groups receiving either a placebo ( PLB ) , 20 000 or 40 000 IU/week oral vitamin D3 for 12 weeks . Serum 25[OH]D and muscle function ( 1-RM bench press and leg press and vertical jump height ) were measured presupplementation , 6 and 12 weeks postsupplementation . Vitamin D deficiency was defined in accordance with the US Institute of Medicine guideline ( 57 % of the subject population were vitamin D deficient at baseline ( mean±SD value 51±24 nmol/l ) . Following 6 and 12 weeks supplementation with 20 000 IU ( 79±14 and 85±10 nmol/l , respectively ) or 40 000 IU vitamin D3 ( 98±14 and 91±24 nmol/l , respectively ) , serum vitamin D concentrations increased in all participants , with every individual achieving concentrations greater than 50 nmol/l . In contrast , vitamin D concentration in the PLB group decreased at 6 and 12 weeks ( 37±18 and 41±22 nmol/l , respectively ) . Increasing serum 25[OH]D had no significant effect on any physical performance parameter ( p>0.05 ) . Conclusions Both 20 000 and 40 000 IU vitamin D3 supplementation over a 6-week period elevates serum 25[OH]D concentrations above 50 nmol/l , but neither dose given for 12 weeks improved our chosen measures of physical performance ",
"Abstract Incidence of vitamin D deficiency is increasing worldwide . The purpose of this study was to determine if supplementation with vitamin D2 from Portobello mushroom powder would enhance skeletal muscle function and attenuate exercise-induced muscle damage in low vitamin D status high school athletes . Participants were r and omised to Portobello mushroom powder ( 600 IU/d vitamin D2 ) or placebo for 6 weeks . Participants then completed a 1.5-h exercise session design ed to induce skeletal muscle damage . Blood sample s and measures of skeletal muscle function were taken pre-supplementation , post-supplementation/pre-exercise and post-exercise . Six weeks supplementation with vitamin D2 increased serum 25(OH)D2 by 9.9-fold and decreased serum 25(OH)D3 by 28 % . Changes in skeletal muscle function and circulating markers of skeletal muscle damage did not differ between groups . In conclusion , 600 IU/d vitamin D2 increased 25(OH)D2 with a concomitant decrease in 25(OD)D3 , with no effect on muscular function or exercise-induced muscle damage in high school athletes",
"Purpose This paper visualizes the available data on vitamin D status on a global map , examines the existing heterogeneities in vitamin D status and identifies research gaps . Methods A graphical illustration of global vitamin D status was developed based on a systematic review of the worldwide literature published between 1990 and 2011 . Studies were eligible if they included sample s of r and omly selected males and females from the general population and assessed circulating 25-hydroxyvitamin D [ 25(OH)D ] levels . Two different age categories were selected : children and adolescents ( 1–18 years ) and adults ( > 18 years ) . Studies were chosen to represent a country based on a hierarchical set of criteria . Results In total , 200 studies from 46 countries met the inclusion criteria , most coming from Europe . Forty-two of these studies ( 21 % ) were classified as representative . In children , gaps in data were identified in large parts of Africa , Central and South America , Europe , and most of the Asia/Pacific region . In adults , there was lack of information in Central America , much of South America and Africa . Large regions were identified for which the mean 25(OH)D levels were below 50 nmol/L. Conclusions This study provides an overview of 25(OH)D levels around the globe . It reveals large gaps in information in children and adolescents and smaller but important gaps in adults . In view of the importance of vitamin D to musculoskeletal growth , development , and preservation , and of its potential importance in other tissues , we strongly encourage new research to clearly define 25(OH)D status around the world"
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41174790-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Pharmacological treatments have been successfully used to treat Generalized Anxiety Disorder ( GAD ) . The mainstay for the pharmacological treatment of GAD in past decades has been the use of benzodiazepine and non benzodiazepine anxiolytics . Data emerging over the last two decades have shown that antidepressants may be equally effective to anxiolytics for treating GAD . The use of antidepressants for treating GAD may be advantageous , due to the fact that GAD presents a high co morbidity ratio with major depressive disorder ( 62 % ) and dysthymia ( 37 % ) . OBJECTIVES To assess the efficacy and acceptability of antidepressants for treating generalized anxiety disorder . SEARCH STRATEGY Cochrane Collaboration Depression , Anxiety and Neurosis Controlled Trials Register - CCDANCTR ( up to May 2002 ) , Anxiety Neurosis ( up to May 2002 ) and Cochrane Controlled Trials Register ( CENTRAL /CCTR ) ( up to May 2002 ) , MEDLINE ( 1966 to May 2002 ) , LILACS ( 1982 to May 2002 ) ; reference search ing ; personal communication ; conference abstract s and book chapters on the treatment of generalized anxiety disorder . SELECTION CRITERIA R and omised controlled trials were included . Exclusion criteria were : non r and omised studies ; studies which included patients with generalized anxiety disorder and another Axis I co-morbidity . DATA COLLECTION AND ANALYSIS The data from studies were extracted independently by two review ers and relative risks , weighted mean difference and number needed to treat were estimated . People who died or dropped out were regarded as having had no improvement . MAIN RESULTS Antidepressants ( imipramine , venlafaxine and paroxetine ) were found to be superior to placebo in treating GAD . The calculated NNT for antidepressants in GAD is 5.15 . Dropout rates did not differ between antidepressants . Only one study presented data on imipramine and trazodone . Imipramine was chosen as the reference drug and , therefore , data on trazodone could not be included in the meta analysis . Only one study was conducted among children and adolescents ( Rynn 2001 ) . The latter study showed very promising results of sertraline in children and adolescents with GAD , which warrants its replication in larger sample s. REVIEW ER 'S CONCLUSIONS The available evidence suggests that antidepressants are superior to placebo in treating GAD . There is evidence from one trial suggesting that paroxetine and imipramine have a similar efficacy and tolerability . There is also evidence from placebo-controlled trials suggesting that these drugs are well tolerated by GAD patients . Further trials of antidepressants for GAD will help to demonstrate which antidepressants should be used for which patients
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"Two hundred and forty neurotic out- patients were allocated to no diagnostic category but were rated in terms of observer and self ratings of both depression and anxiety at weekly intervals during a 4-week trial of amitriptyline , diazepam , amitriptyline and diazepam , and placebo . The sample could not be divided into anxious and depressed groups on the basis of the clinical picture . The outcome tended to be good irrespective of medication but the significant drug effects found were due to amitriptyline and concerned measures of anxiety as well as depression . It is concluded that a distinction between anxiety and depression in neurotic out- patients is of no practical value with regard to drug treatment",
"OBJECTIVE This study evaluated the efficacy and safety of fixed doses of once-daily extended-release ( XR ) venlafaxine in out patients with generalized anxiety disorder without concomitant major depressive disorder . METHOD Adult out patients with generalized anxiety disorder but not major depressive disorder with total scores of 18 or higher on the Hamilton Rating Scale for Anxiety and scores of 2 or higher on its anxious mood and tension factors were eligible . Patients were r and omly assigned to receive placebo or venlafaxine XR ( 75 , 150 , or 225 mg/day ) for 8 weeks . Primary efficacy variables were final total and psychic anxiety factor scores on the Hamilton anxiety scale and final severity and global improvement item scores on the Clinical Global Impression ( CGI ) scale . RESULTS Of the 377 patients entering the study , 370 were included in a safety analysis and 349 in an efficacy analysis . Adjusted mean scores at 8 weeks ( last-observation-carried-forward analysis ) were significantly lower for one or more of the venlafaxine XR groups in four of four primary and three of four secondary outcome measures than for the placebo group . These included a change of 1.7 ( versus 1.3 ) from baseline on CGI severity item scores and a final score of 2.2 ( versus 2.6 ) on the CGI global improvement item . All doses of venlafaxine XR were well tolerated . CONCLUSIONS Venlafaxine XR is an effective and well-tolerated option for the short-term treatment of generalized anxiety disorder in out patients without major depressive disorder",
"OBJECTIVE This report examines the impact of panic disorder and /or generalized anxiety disorder on quality of life and the implication s of these findings on nosological categories . METHOD A total of 357 subjects with a current episode of panic disorder and /or generalized anxiety disorder were diagnosed according to DSM-III-R criteria , using structured clinical interviews , as part of a prospect i ve , naturalistic , longitudinal , multicenter study of a clinical population with anxiety disorders . RESULTS There was a high degree of coexistence of anxiety disorders and major depressive disorder . Subjects with generalized anxiety disorder almost universally had other disorders , were the most likely to have at least one other anxiety disorder or major depressive disorder at intake , had the earliest age at onset , and had the worst emotional health rating . Subjects with panic disorder without agoraphobia had the most likelihood of a history of alcohol abuse . Nine percent of the subjects had a history of suicide attempts or gestures . CONCLUSIONS The subjects showed significant impairment in quality of life . The highly frequent coexistence of other anxiety disorders with generalized anxiety disorder and the overall lack of differences on many quality of life measures raise questions of nosology , particularly for generalized anxiety disorder",
"BACKGROUND The objective of this r and omized , double-blind study was to compare the efficacy and safety of venlafaxine extended release ( XR ) and buspirone in out patients with generalized anxiety disorder ( GAD ) but without concomitant major depressive disorder . METHOD Male and female out patients at least 18 years old who met the DSM-IV criteria for GAD and had scores of 18 or higher on the Hamilton Rating Scale for Anxiety ( HAM-A ) were r and omly assigned to treatment with either venlafaxine XR ( 75 or 150 mg/day ) , buspirone ( 30 mg/day in 3 divided doses ) , or placebo for 8 weeks . The primary efficacy variables were changes in anxiety as determined by final on-therapy HAM-A total and psychic anxiety scores and Clinical Global Impressions scale ( CGI ) scores . Other key efficacy variables were HAM-A anxious mood and tension scores and the anxiety subscale scores of the patient-rated Hospital Anxiety and Depression scale ( HAD ) . RESULTS The efficacy analysis included 365 patients and the safety analysis , 405 . At week 8 , adjusted mean HAM-A psychic anxiety , anxious mood , and tension scores were significantly lower for venlafaxine XR-treated patients than for placebo-treated patients . On the HAD anxiety subscale , venlafaxine XR , 75 or 150 mg/day , was significantly more efficacious than placebo at all time points except weeks 1 ( both dosages ) and 2 ( 150-mg/day dosage only ) and significantly more efficacious than buspirone at all time points except week 1 . On the CGI-Improvement scale , scores for venlafaxine XR ( both dosages ) and buspirone were numerically superior to those for placebo at all time points , and statistical significance was observed at weeks 3 , 4 , 6 , and 8 for venlafaxine XR and at weeks 6 and 8 for buspirone . The adverse events were not essentially different between treatment groups . CONCLUSION Venlafaxine XR is an effective , safe , and well-tolerated once-daily anxiolytic agent in patients with GAD without comorbid major depressive disorder . This agent was significantly superior to buspirone on the HAD anxiety subscale . Buspirone demonstrated statistical significance versus placebo on a measure of anxiolytic response",
"BACKGROUND The diagnostic category of generalised anxiety disorder ( GAD ) was originally intended to describe residual anxiety states . Over the years clinical criteria have been refined in an attempt to describe a unique diagnostic entity . Given these changes , little is known about the clinical course of this newly defined disorder . This study investigates the longitudinal course , including remission and relapse rates , for patients with DSM-III-R defined GAD . METHOD Analysis of the 164 patients with GAD participating in the Harvard Anxiety Research Program . Patients were assessed with a structured clinical interview at intake and re-examined at six month intervals for two years and then annually for one to two years . Psychiatric Status Ratings were assigned at each interview point . Kaplan-Meier curves were constructed to assess likelihood of remission . RESULTS Comorbidity was high , with panic disorder and social phobia as the most frequently found comorbid disorders . The likelihood of remission was 0.15 after one year and 0.25 after two years . The probability of becoming asymptomatic from all psychiatric symptoms was only 0.08 . CONCLUSIONS This prospect i ve study confirms the chronicity associated with GAD and extends this finding to define the one and two year remission rates for the disorder . Likelihood of remission for GAD and any other comorbid condition after one year was half the annual remission rate for GAD alone",
"In a 4 week study of the response of neurotic out patients to treatment with amitriptyline , diazepam , amitriptyline and diazepam , or placebo , clinical and psychophysiological variables and plasma levels of the drug were assessed . Clinical improvements were substantial in all treatment groups but clear relationships between clinical change , psychophysiological change and plasma levels of the drugs were not established . There was no relationship between plasma levels of the drugs and cigarette smoking . It is concluded that neither plasma levels of amitriptyline and diazepam nor change in skin conductance responsivity offer a useful guide to clinical response to drug treatment",
"Recently , there has been a renewed interest in alternatives to the benzodiazepines for the treatment of generalized anxiety disorder ( GAD ) . The aim of the present study was to compare the efficacy of paroxetine vs. imipramine and 2′‐chlordesmethyldiazepam in 81 patients with a DSM‐IV diagnosis of GAD . Approximately two‐thirds of the patients who completed the study improved greatly or moderately on all three active drugs . During the first 2 weeks of treatment , 2′‐chlordesmethyldiazepam treatment result ed in the greatest improvement in anxiety ratings . Both paroxetine and imipramine treatment result ed in more improvement than 2′‐chlordesmethyldiazepam by the fourth week of treatment . Paroxetine and imipramine affect predominantly psychic symptoms , whereas 2′‐chlordesmethyldiazepam affects predominantly somatic symptoms . Our results suggest that paroxetine is effective for the treatment of GAD ",
"OBJECTIVE Patients with generalized anxiety disorder ( N=107 ) who had been long-term benzodiazepine users ( average duration of use=8.5 years ) were enrolled in a benzodiazepine discontinuation program that assessed the effectiveness of concomitant imipramine ( 180 mg/day ) and buspirone ( 38 mg/day ) compared to placebo in facilitating benzodiazepine discontinuation . METHOD After a benzodiazepine stabilization period taking either diazepam , lorazepam , or alprazolam , patients were treated for 4 weeks with imipramine , buspirone , or placebo under double-blind conditions while benzodiazepine intake was kept stable ( treatment phase ) . Patients then entered a 4 - 6 week benzodiazepine taper and a 5-week posttaper phase with imipramine , buspirone , and placebo treatment being continued until 3 weeks into the posttaper phase , at which time all patients were switched to placebo for 2 weeks . Benzodiazepine plasma levels were assayed weekly . Benzodiazepine-free status was assessed 3 and 12 months posttaper . RESULTS Study subjects were long-term benzodiazepine users with an average of three unsuccessful prior taper attempts . The success rate of the taper in this study was significantly higher for patients who received imipramine ( 82.6 % ) , and nonsignificantly higher for patients who received buspirone ( 67.9 % ) , than for patients who received placebo ( 37.5 % ) . The imipramine effect remained highly significant even after the analysis adjusted for three other independent predictors of taper success : benzodiazepine dose , level of anxious symptoms at baseline , and duration of benzodiazepine therapy . CONCLUSIONS Management of benzodiazepine discontinuation can be facilitated significantly by co-prescribing imipramine before and during the benzodiazepine taper . Daily benzodiazepine dose , severity of baseline symptoms of anxiety and depression , and duration of benzodiazepine use were additional significant predictors of successful taper outcome",
"OBJECTIVE The current study examines whether antidepressants , contrary to current thinking , are safe and effective treatments for generalized anxiety disorder ( GAD ) not complicated by depression or panic disorder . DESIGN R and omized , double-blind , placebo-controlled , flexible-dose , 8-week treatment study comparing imipramine hydrochloride ( mean maximum daily dose , 143 mg ) , trazodone hydrochloride ( 255 mg ) , and diazepam ( 26 mg ) . PATIENTS Two hundred thirty patients with a DSM-III diagnosis of GAD in whom major depression and panic disorder has been excluded , and who had a Hamilton Anxiety Scale total score of at least 18 . SETTING Seventy-five percent of patients were treated in family practice setting s in the community , with the remainder treated in psychiatric practice s , either academic or private . RESULTS Patients treated with diazepam showed the most improvement in anxiety ratings during the first 2 weeks of treatment , with somatic symptoms being most responsive . From week 3 through week 8 trazodone achieved comparable , and imipramine somewhat better , anxiolytic efficacy when compared with diazepam , with psychic symptoms of tension , apprehension , and worry being more responsive to the antidepressants . Among completers , moderate to marked improvement was reported by 73 % of patients treated with imipramine , 69 % of patients treated with trazodone , 66 % of patients treated with diazepam , but only 47 % of patients treated with placebo . Overall , patients treated with antidepressants reported a higher rate of adverse effects than diazepam-treated patients , but attention rates were the same across all treatments . CONCLUSIONS The results of the study need replication , but suggest a potentially important role for antidepressants , particularly imipramine , in patients suffering from GAD",
"BACKGROUND The objective of this r and omized , double-blind , placebo-controlled study was to investigate the efficacy and safety of paroxetine in out patients with generalized anxiety disorder ( GAD ) . METHOD Male and female out patients 18 years and older who met DSM-IV criteria for GAD and had baseline scores of at least 20 on the Hamilton Rating Scale for Anxiety ( HAM-A ) were r and omly assigned to treatment with paroxetine ( 20 - 50 mg/day ) or placebo for 8 weeks . The primary efficacy variable was the mean change from baseline in the total score of the HAM-A. Additional key efficacy variables were the change from baseline in the scores of the HAM-A items anxious mood and tension , the anxiety subscale of the Hospital Anxiety and Depression Scale , and the Sheehan Disability Scale ( SDS ) . The proportions of patients fulfilling response and remission criteria at week 8 were also determined . RESULTS The intent-to-treat population included 324 patients . At week 8 , compared with the placebo group ( N = 163 ) , the paroxetine group ( N = 161 ) had a significantly greater reduction of GAD symptoms on all of the above-mentioned efficacy variables . On the HAM-A anxious mood item , which encompasses the cardinal symptoms of GAD , significantly greater efficacy was observed from week 1 and on the SDS significantly greater improvement was documented in the domain \" social life \" as early as week 4 for paroxetine compared with placebo . In both the last-observation-carried-forward and completer data sets , significantly greater proportions of paroxetine-treated patients achieved response or remission by week 8 . Treatment with paroxetine was well tolerated , and the number and type of adverse events recorded in the paroxetine group correspond to the known safety profile of this medication . CONCLUSION Paroxetine in doses of 20 to 50 mg once daily is effective in the treatment of patients with GAD . Improvement of core symptoms of GAD occurs early and is associated with significant reduction in disability after only 8 weeks of treatment",
"OBJECTIVE The study compared the safety and efficacy of sertraline , a selective serotonin reuptake inhibitor , and placebo in the treatment of generalized anxiety disorder in children and adolescents . METHOD The study subjects were 22 children and adolescents age 5 - 17 years who met the DSM-IV criteria for generalized anxiety disorder according to the Anxiety Disorders Interview Schedule for Children-Revised and who had a Hamilton Anxiety Rating Scale score > or = 16 . The patients underwent a 2 - 3-week pre study evaluation period , followed by a 9-week double-blind treatment phase in which they were r and omly assigned in blocks of four to receive either sertraline or pill placebo . The maximum dose of sertraline was 50 mg/day . Primary outcome measures were the Hamilton anxiety scale and the Clinical Global Impression scale . RESULTS The Hamilton anxiety scale total score , psychic factor , and somatic factor and the Clinical Global Impression severity and improvement scales showed significant differences with treatment in favor of sertraline over placebo beginning at week 4 . Self-report measures reflected these results at the end of treatment . CONCLUSIONS The results of this double-blind , placebo-controlled trial suggest that sertraline at the daily dose of 50 mg is safe and efficacious for the treatment of generalized anxiety disorder in children and adolescents",
"BACKGROUND Generalised anxiety disorder ( GAD ) has received less study than other anxiety disorders , particularly its long-term treatment . AIMS To assess the efficacy and safety of venlafaxine extended release ( ER ) in patients with GAD . METHOD A total of 541 out- patients , 18 - 86 years old , were recruited to this 24-week , placebo-controlled , double-blind study of three fixed doses ( 37.5 , 75 and 150 mg/day ) of venlafaxine ER . RESULTS All doses of venlafaxine ER showed efficacy superior to placebo , apparent from week 2 , that was sustained throughout the 24-week study for the two higher doses . The discontinuation rate did not differ significantly among the treatment groups . CONCLUSIONS Venlafaxine ER is an effective and safe treatment for GAD for up to 6 months",
"CONTEXT Generalized anxiety disorder ( GAD ) is a chronic disorder that is associated with debilitating psychic and somatic symptoms . Venlafaxine extended-release ( XR ) capsules have been shown to be effective in short-term treatment of patients with GAD without major depressive disorder ( MDD ) , but long-term data are needed to establish whether this agent confers persistent benefits . OBJECTIVE To compare the 6-month efficacy and safety of a flexible dosage of venlafaxine XR in out patients with GAD without associated MDD . DESIGN Six-month , r and omized , double-blind , placebo-controlled , parallel-group trial conducted May 1996 to October 1997 . SETTING Fourteen outpatient clinics and private psychiatric practice s in the United States . PARTICIPANTS A total of 251 out patients aged 18 years or older who met Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition ( DSM-IV ) criteria for GAD , had sufficient symptoms to require treatment , and did not have coexisting MDD . INTERVENTIONS Participants were r and omly assigned to receive either placebo ( n=127 ) or venlafaxine XR ( 75 , 150 , or 225 mg/d , as required to control symptoms ; n=124 ) for 28 weeks . MAIN OUTCOME MEASURES Changes from baseline in the Hamilton Rating Scale for Anxiety ( HAM-A ) total score , the HAM-A psychic anxiety factor score , and the Clinical Global Impressions ( CGI ) scale Severity of Illness and Global Improvement scores , compared by intervention group . RESULTS During weeks 6 through 28 , response rates in the venlafaxine XR group were 69 % or higher compared with rates of 42 % to 46 % in the placebo group ( P venlafaxine XR compared with placebo significantly improved anxiety scores from week 1 or 2 through week 28 on all primary efficacy measures , including the HAM-A total ( P the HAM-A psychic anxiety factor ( P the CGI scale scores ( P venlafaxine XR -13.4 , placebo -8.7 ( P HAM-A psychic anxiety score , venlafaxine XR -7.4 , placebo -4.2 ( P CGI-Improvement , venlafaxine XR 2.2 , placebo 3.0 ( P adverse event was nausea , followed by somnolence and dry mouth . CONCLUSIONS This study is the first placebo-controlled demonstration of the long-term efficacy of any drug class in treating out patients with DSM-IV-diagnosed GAD . Venlafaxine XR is an effective , rapidly acting , safe , once-daily agent for both the short- and long-term treatment of anxiety and may provide an important alternative to currently available anxiolytics . JAMA . 2000",
" We r and omly assigned 425 out patients , independently classified as primarily depressed by two trained psychiatrists , to double-blind treatment with Imipramine hydrochloride , chlordiazepoxide hydrochloride , or placebo . Those patients who remained at least moderately depressed ( following a two-week placebo washout period ) were treated for an additional eight weeks . An endpoint analysis of 387 patients who completed two or more weeks of medication disclosed early therapeutic advantages of chlordiazepoxide . By week 4 of treatment , however , imipramine produced more improvement than did placebo and chlordiazepoxide . By six and eight weeks a general , marked therapeutic advantage was found for imipramine relative to placebo and to chlordiazepoxide on measures of depression , anxiety , anger-hostility , interpersonal sensitivity , and global improvement . Chlordiazepoxide-treated patients generally did significantly better on sleep difficulty but significantly worse on anger-hostility and interpersonal sensitivity than did imipramine- or placebo-treated patients"
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411747cc-06ff-11f0-808a-c43d1ab1c353
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Objective : To assess the effectiveness of aquatic physical therapy in the treatment of fibromyalgia . Data sources : The search strategy was undertaken using the following data bases , from 1950 to December 2012 : MEDLINE , EMBASE , CINAHL , LILACS , SCIELO , WEB OF SCIENCE , SCOPUS , SPORTD iscus , Cochrane Library Controlled Trials Register , Cochrane Disease Group Trials Register , PEDro and DARE . Review methods : The studies were separated into groups : Group I – aquatic physical therapy × no treatment , Group II – aquatic physical therapy × l and -based exercises and Group III – aquatic physical therapy × other treatments . Results : Seventy-two abstract s were found , 27 of which met the inclusion criteria . For the functional ability ( Fibromyalgia Impact Question naire ) , three studies were considered with a treatment time of more than 20 weeks and a mean difference ( MD ) of −1.35 [ −2.04 ; −0.67 ] , P = 0.0001 was found in favour of the aquatic physical therapy group versus no treatment . The same results were identified for stiffness and the 6-minute walk test where two studies were pooled with an MD of −1.58 [ −2.58 ; −0.58 ] , P = 0.002 and 43.5 ( metres ) [ 3.8 ; 83.2 ] , P = 0.03 , respectively . Conclusion : Three meta-analyses showed statistically significant results in favour of the aquatic physical therapy ( Fibromyalgia Impact Question naire , stiffness and the 6-minute walk test ) during a period of longer than 20 weeks . Due to the low method ological rigor , the results were insufficient to demonstrate statistical and clinical differences in most of the outcomes
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"OBJECTIVE To evaluate the feasibility of 8 months of supervised exercise therapy in warm water and its effects on the impact of fibromyalgia on physical and mental health and physical fitness in affected women . METHODS Thirty women with fibromyalgia were r and omly assigned to an exercise therapy group ( n = 15 ) or a control group ( inactive ) ( n = 15 ) . The impact of fibromyalgia on physical and mental health was assessed using the Fibromyalgia Impact Question naire and the anxiety state with State-Trait Anxiety Inventory . Physical fitness was measured using the following tests : Canadian Aerobic Fitness ; h and -grip dynamometry ; 10-metre walking ; 10-step stair-climbing and blind 1-leg stance . RESULTS After 8 months of training , the exercise therapy group improved compared with the control group in terms of physical function ( 20 % ) , pain ( 8 % ) , stiffness ( 53 % ) , anxiety ( 41 % ) , depression ( 27 % ) , Fibromyalgia Impact Question naire total scores ( 18 % ) , State-Trait Anxiety Inventory score ( 22 % ) , aerobic capacity ( 22 % ) , balance ( 30 % ) , functional capacity for walking ( 6 % ) , stair-climbing with no extra weight ( 14 % ) and stair-climbing 10 kg-weighted ( 25 % ) . CONCLUSION Eight months of supervised exercise in warm water was feasible and led to long-term improvements in physical and mental health in patients with fibromyalgia at a similar magnitude to those of shorter therapy programmes",
"The present study tested the hypothesis that perceived exertion during prolonged exercise in hot environments is associated with changes in cerebral electrical activity rather than changes in the electromyogram ( EMG ) of the exercising muscles . Therefore , electroencephalogram ( EEG ) in three positions ( frontal , central , and occipital cortex ) , EMG , rating of perceived exertion ( RPE ) , and core temperature were measured in 14 subjects during submaximal exercise in normal ( 18 degrees C , control ) and hot ( 40 degrees C , hyperthermia ) environments . RPE increased from 11 + /- 1 units at 5 min to 20 + /- 0 units at exhaustion ( 50 + /- 3 min ) in the trial with progressive hyperthermia , whereas exercise in the control trial was maintained with a stable core temperature for 1 h without exhausting the subjects . Altered EEG activity was observed in all electrode positions , and stepwise forward-regression analysis identified core temperature and a frequency index of the EEG over the frontal cortex as the best predictors of RPE . In contrast , there were no significant correlations between RPE and any of the measured EMG parameters ( median spectral frequency , root mean square , or amplitude ) , and the EMG parameters were not different in hyperthermia compared with control . Thus hyperthermia does not seem to affect the activation pattern of the muscles . Rather , the linear correlation among core temperature , EEG frequency index , and RPE indicates that alterations in cerebral activity may be associated with the hyperthermia-induced development of fatigue during prolonged exercise in hot environments",
"Objective : To evaluate the efficacy of a treatment programme for patients with fibromyalgia ( FM ) based on self management , using pool exercises and education . Methods : R and omised controlled trial with a 6 month follow up to evaluate an outpatient multidisciplinary programme ; 164 patients with FM were allocated to an immediate 6 week programme ( n = 84 ) or to a waiting list control group ( n = 80 ) . The main outcomes were changes in quality of life , functional consequences , patient satisfaction and pain , using a combination of patient question naires and clinical examinations . The question naires included the Fibromyalgia Impact Question naire ( FIQ ) , Psychological General Well-Being ( PGWB ) index , regional pain score diagrams , and patient satisfaction measures . Results : 61 participants in the treatment group and 68 controls completed the programme and 6 month follow up examinations . Six months after programme completion , significant improvements in quality of life and functional consequences of FM were seen in the treatment group as compared with the controls and as measured by scores on both the FIQ ( total score p = 0.025 ; fatigue p = 0.003 ; depression p = 0.031 ) and PGWB ( total score p = 0.032 ; anxiety p = 0.011 ; vitality p = 0.013 , ) . All four major areas of patient satisfaction showed greater improvement in the treatment than the control groups ; between-group differences were statistically significant for “ control of symptoms ” , “ psychosocial factors ” , and “ physical therapy ” No change in pain was seen . Conclusion : A 6 week self management based programme of pool exercises and education can improve the quality of life of patients with FM and their satisfaction with treatment . These improvements are sustained for at least 6 months after programme completion",
"OBJECTIVE To evaluate the effectiveness and tolerability of two pool-based physical therapies , stretching and Ai Chi , in fibromyalgia symptomatology and sleep quality . METHODS Eighty-one patients , r and omly assigned to stretching ( n=39 ) or Ai Chi ( n=42 ) , received 18 physiotherapy sessions and were evaluated at baseline , at treatment termination , and after 4 and 12 weeks of follow-up . Main outcome measures were the Fibromyalgia Impact Question naire ( FIQ ) and the Pittsburgh Sleep Quality Index ( PSQI ) . Secondary outcome measures included the Beck Depression Inventory ( BDI ) , the State and Trait Anxiety Inventory ( STAI ) , and the SF-12 Health Survey ( SF-12 ) . Data analysis was done with repeated measures ANOVA and effect size estimation . RESULTS No differences were found between groups but significant reduction in the FIQ and the PSQI scores were observed in Ai Chi but not in stretching group , with larger effect sizes and longer effect duration on sleep measures . BDI scores decreased in stretching but not in Ai Chi group with small effect sizes . Trait-anxiety scores decreased in both groups also with small effect sizes . The mental component summary of the SF-12 increased only in stretching group with effect sizes moderate to large . CONCLUSIONS Although no global differences were found between groups , Ai Chi significantly improved fibromyalgia symptomatology and sleep quality , whereas stretching only improved subjects ' psychological well-being",
"We investigated whether fatigue during prolonged exercise in uncompensable hot environments occurred at the same critical level of hyperthermia when the initial value and the rate of increase in body temperature are altered . To examine the effect of initial body temperature [ esophageal temperature ( Tes ) = 35.9 + /- 0.2 , 37.4 + /- 0 . 1 , or 38.2 + /- 0.1 ( SE ) degrees C induced by 30 min of water immersion ] , seven cyclists ( maximal O2 uptake = 5.1 + /- 0.1 l/min ) performed three r and omly assigned bouts of cycle ergometer exercise ( 60 % maximal O2 uptake ) in the heat ( 40 degrees C ) until volitional exhaustion . To determine the influence of rate of heat storage ( 0.10 vs. 0.05 degrees C/min induced by a water-perfused jacket ) , four cyclists performed two additional exercise bouts , starting with Tes of 37.0 degrees C. Despite different initial temperatures , all subjects fatigued at an identical level of hyperthermia ( Tes = 40 . 1 - 40.2 degrees C , muscle temperature = 40.7 - 40.9 degrees C , skin temperature = 37.0 - 37.2 degrees C ) and cardiovascular strain ( heart rate = 196 - 198 beats/min , cardiac output = 19.9 - 20.8 l/min ) . Time to exhaustion was inversely related to the initial body temperature : 63 + /- 3 , 46 + /- 3 , and 28 + /- 2 min with initial Tes of approximately 36 , 37 , and 38 degrees C , respectively ( all P exhaustion at similar Tes and muscle temperature ( 40.1 - 40.3 and 40 . 7 - 40.9 degrees C , respectively ) , but with significantly different skin temperature ( 38.4 + /- 0.4 vs. 35.6 + /- 0.2 degrees C during high vs. low rate of heat storage , respectively , P Time to exhaustion was significantly shorter at the high than at the lower rate of heat storage ( 31 + /- 4 vs. 56 + /- 11 min , respectively , P Increases in heart rate and reductions in stroke volume paralleled the rise in core temperature ( 36 - 40 degrees C ) , with skin blood flow plateauing at Tes of approximately 38 degrees C. These results demonstrate that high internal body temperature per se causes fatigue in trained subjects during prolonged exercise in uncompensable hot environments . Furthermore , time to exhaustion in hot environments is inversely related to the initial temperature and directly related to the rate of heat storage",
"Aim Previous systematic review s have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome ( FMS ) . The aim of this systematic review was to summarize the components of hydrotherapy programs used in r and omized controlled trials . Method A systematic review of r and omized controlled trials was conducted . Only trials that have reported significant FMS-related outcomes were included . Data relating to the components of hydrotherapy programs ( exercise type , duration , frequency and intensity , environmental factors , and service delivery ) were analyzed . Results Eleven r and omized controlled trials were included in this review . Overall , the quality of trials was good . Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component . Great variability was noted in both the environmental components of hydrotherapy programs and service delivery . Conclusions Aerobic exercise , warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes . Treatment duration of 60 minutes , frequency of three sessions per week and an intensity equivalent to 60%–80 % maximum heart rate were the most commonly reported exercise components . Exercise appears to be the most important component of an effective hydrotherapy program for FMS , particularly when considering mental health-related outcomes",
"Introduction Physical therapy in warm water has been effective and highly recommended for persons with fibromyalgia , but its efficiency remains largely unknown . Should patients or health care managers invest in this therapy ? The aim of the current study was to assess the cost-utility of adding an aquatic exercise programme to the usual care of women with fibromyalgia . Methods Costs to the health care system and to society were considered in this study that included 33 participants , r and omly assigned to the experimental group ( n = 17 ) or a control group ( n = 16 ) . The intervention in the experimental group consisted of a 1-h , supervised , water-based exercise sessions , three times per week for 8 months . The main outcome measures were the health care costs and the number of quality -adjusted life-years ( QALYs ) using the time trade-off elicitation technique from the EuroQol EQ-5D instrument . Sensitivity analyses were performed for variations in staff salary , number of women attending sessions and time spent going to the pool . The cost effectiveness acceptability curves were created using a non-parametric bootstrap technique . Results The mean incremental treatment costs exceeded those for usual care per patient by € 517 for health care costs and € 1,032 for societal costs . The mean incremental QALY associated with the intervention was 0.131 ( 95 % CI : 0.011 to 0.290 ) . Each QALY gained in association with the exercise programme cost an additional € 3,947/QALY ( 95 % CI : 1,782 to 47,000 ) for a health care perspective and € 7,878/QALY ( 3,559 to 93,818 ) from a societal perspective . The curves showed a 95 % probability that the addition of the water-based programme is a cost-effective strategy if the ceiling of inversion is € 14,200/QALY from a health care perspective and € 28,300/QALY from a societal perspective . Conclusion The addition of an aquatic exercise programme to the usual care regime for fibromyalgia in women is cost effective in terms of both health care costs and societal costs . However , the characteristics of facilities ( distance from the patients ' homes and number of patients that can be accommo date d per session ) are major determinants to consider before investing in such a programme . Trial registration Current controlled trials IS RCT N53367487",
"OBJECTIVE To evaluate the effects of 6 months of pool exercise combined with a 6 session education program for patients with fibromyalgia syndrome ( FM ) . METHODS The study population comprised 58 patients , r and omized to a treatment or a control group . Patients were instructed to match the pool exercises to their threshold of pain and fatigue . The education focused on strategies for coping with symptoms and encouragement of physical activity . The primary outcome measurements were the total score of the Fibromyalgia Impact Question naire ( FIQ ) and the 6 min walk test , recorded at study start and after 6 mo . Several other tests and instruments assessing functional limitations , severity of symptoms , disabilities , and quality of life were also applied . RESULTS Significant differences between the treatment group and the control group were found for the FIQ total score ( p = 0.017 ) and the 6 min walk test ( p physical function , grip strength , pain severity , social functioning , psychological distress , and quality of life . CONCLUSION The results suggest that a 6 month program of exercises in a temperate pool combined with education will improve the consequences of FM",
"The aim of this study was to evaluate the effectiveness of aerobic exercise in water pool compared with aerobic exercise performed in sea by women with fibromyalgia ( FM ) . A total of 46 patients were r and omly allocated into two groups : pool group ( 23 patients ) and sea group ( 23 patients ) that performed the same aerobic exercise program . Patients were evaluated baseline and after 12 weeks using : VAS , number of tender points , FIQ , SF-36 , PSQI , and BDI . Both groups improved significantly in post-treatment for all the evaluated variables . There were no significant differences between two groups , except for BDI ( F = 2.418 , P Aerobic exercise program performed in water ( pool or sea ) was effective for patients with FM . However , sea water exercises have been shown to bring more advantages related to emotional aspects . Then , exercise performed sea water ( thalassotherapy ) is an option for effective treatment with low cost for patients with FM",
"OBJECTIVE To measure mood and physical function of individuals with fibromyalgia , 6 and 12 months following 23 weeks of supervised aerobic exercise . METHODS This is a followup report of individuals who were previously enrolled in 23 weeks of l and -based and water-based aerobic exercise classes . Outcomes included the 6-minute walk test , Beck Depression Inventory ( BDI ) , State-Trait Anxiety Inventory , Arthritis Self-Efficacy Scale ( ASES ) , Fibromyalgia Impact Question naire ( FIQ ) , tender point count , patient global assessment score , and exercise compliance . Outcomes were measured at the start and end of the exercise classes and 6 and 12 months later . RESULTS Analyses were conducted on 29 ( intent-to-treat ) or 18 ( efficacy ) subjects . Six-minute walk distances and BDI total scores were improved at followup ( all analyses ) . BDI cognitive/affective scores were improved at the end of 23 weeks of exercise ( both analyses ) and at the 12-month followup ( efficacy analysis only ) . BDI somatic scores were improved at 6-month ( both analyses ) and 12-month followup ( intent-to-treat only ) . FIQ and ASES function were improved at all followup points . ASES pain was improved in efficacy analyses only ( all followup points ) . Tender points were unchanged after 23 weeks of exercise and at followup . Exercise duration at followup ( total minutes of aerobic plus anaerobic exercise in the preceding week ) was related to gains in physical function ( 6- and 12-month followup ) and mood ( 6-month followup ) . CONCLUSION Exercise can improve physical function , mood , symptom severity , and aspects of self efficacy for at least 12 months . Exercising at followup was related to improvements in physical function and perhaps mood",
"OBJECTIVES To evaluate the effects of a 16-week exercise therapy in a chest-high pool of warm water through applicable tests in the clinical practice on the global symptomatology of women with fibromyalgia ( FM ) and to determine exercise adherence levels . DESIGN A r and omized controlled trial . SETTING Testing and training were completed at the university . PARTICIPANTS Middle-aged women with FM ( n=60 ) and healthy women ( n=25 ) . INTERVENTION A 16-week aquatic training program , including strength training , aerobic training , and relaxation exercises . MAIN OUTCOME MEASURES Tender point count ( syringe calibrated ) , health status ( Fibromyalgia Impact Question naire ) ; sleep quality ( Pittsburgh Sleep Quality Index ) ; physical ( endurance strength to low loads tests ) , psychologic ( State Anxiety Inventory ) , and cognitive function ( Paced Auditory Serial Addition Task ) ; and adherence 12 months after the completion of the study . RESULTS For all the measurements , the patients showed significant deficiencies compared with the healthy subjects . Efficacy analysis ( n=29 ) and intent-to-treat analysis ( n=34 ) of the exercise therapy was effective in decreasing the tender point count and improving sleep quality , cognitive function , and physical function . Anxiety remained unchanged during the follow-up . The exercise group had a significant improvement of health status , not associated exclusively with the exercise intervention . There were no changes in the control group . Twenty-three patients in the exercise group were exercising regularly 12 months after completing the program . CONCLUSIONS An exercise therapy 3 times a week for 16 weeks in a warm pool could improve most of the symptoms of FM and cause a high adherence to exercise in unfit women with heightened FM symptomatology . The therapeutic intervention 's effects can be assessed through applicable tests in the clinical practice",
"OBJECTIVE To evaluate the efficacy of a 6-week exercise and educational program for patients with fibromyalgia . METHODS Forty-one subjects were r and omly assigned to the program or served as waiting list controls . Program outcome was assessed with a 6-minute walk test , the Fibromyalgia Impact Question naire , a Self-Efficacy Scale , and a \" knowledge \" question naire ( based on information provided during the educational sessions ) . Waiting list control subjects subsequently completed the program . Program outcome was reassessed 3 or 6 months post-program . RESULTS The program produced significant improvements in 6-minute walk distance , well-being , fatigue , self-efficacy ( for controlling pain and other symptoms ) , and knowledge . At followup , immediate gains in walk distance , well-being , and self-efficacy were maintained , but gains in fatigue and knowledge were lost . CONCLUSION Short-term exercise and educational programs can produce immediate and sustained benefits for patients with fibromyalgia . The benefits of our program may be due to exercise or education since both interventions were given",
"OBJECTIVE To analyze the long-term efficacy of 2 interventions for female fibromyalgia ( FM ) patients : 1 ) cognitive-behavioral therapy ( CBT ) , and 2 ) a physical exercise (PE)-based strategy . METHODS We conducted a prospect i ve , long-term , r and omized , parallel clinical trial . The outcome variables are physical activity , aerobic capacity , and results of the Fibromyalgia Impact Question naire ( FIQ ) , Short Form 36 , Beck Anxiety and Depression Inventory , Chronic Pain Self-Efficacy Scale , and Chronic Pain Coping Inventory . All were measured at baseline , posttreatment , 6 months , and 1 year . The duration of both treatments was 8 weeks . RESULTS Some items of the FIQ and some strategies to cope with pain improved significantly in both groups after treatment . All variables measuring functional capacity improved significantly in the PE group , whereas only physical activity of the vertebral column improved in the CBT group . There were no differences in anxiety , depression , and self efficacy after treatment in either group . After 1 year of followup , most of the parameters had returned to baseline values in both groups . However , in the PE group , functional capacity remained significantly better . CONCLUSIONS PE and CBT improve clinical manifestations in FM patients only for short periods of time . Improvement in self efficacy and physical fitness are not associated with improvement in clinical manifestations",
"Objective . To follow patients with fibromyalgia six and 24 months after they finished a six-month treatment programme . The programme comprised pool exercise therapy , adjusted to the patients ' limitations , and education based on their health problems . Methods . Twenty-six patients were examined six and 24 months after the completion of the treatment programme with the Fibromyalgia Impact Question naire ( FIQ ) , SF-36 , the 6-minute walk test , and the Grippit measure . The values obtained at the follow-up examinations were compared with the baseline and post-treatment values . Results . As compared with baseline , symptom severity ( FIQ , SF-36 ) , physical function ( FIQ , SF-36 , 6-minute walk test ) and quality of life ( SF-36 ) still showed improvements six months after the completion of treatment ( p Pain ( FIQ , SF-36 ) , fatigue ( FIQ , SF-36 ) , walking ability , and social function ( SF-36 ) still showed improvements 2 years after the completion of the programme as compared with the baseline values ( p symptom severity , physical function and social function were still found six and 24 months after the completed treatment programme",
"Objective The aim of this study was to compare pool-based exercise and balneotherapy in fibromyalgia syndrome ( FMS ) patients . Methods Fifty female patients diagnosed with FMS according to the American College of Rheumatism ( ACR ) criteria were r and omly assigned to two groups : group 1 ( n=25 ) with pool-based exercise , and in group 2 ( n=25 ) balneotherapy was applied in the same pool without any exercise for 35 min three times a week for 12 weeks . In both groups , pre- ( week 0 ) and post-treatment ( weeks 12 and 24 ) evaluation was performed by one of the authors , who was blind to the patient group . Evaluation parameters included pain , morning stiffness , sleep , tender points , global evaluation by the patient and the physician , fibromyalgia impact question naire , chair test , and Beck depression inventory . Statistical analysis was done on data collected from three evaluation stages . Results Twenty-four exercise and 22 balneotherapy patients completed the study . Pretreatment ( week 0 ) measurements did not show any difference between the groups . In group 1 , statistically significant improvement was observed in all parameters ( P chair test at both weeks 12 and 24 . In group 2 , week 12 measurements showed significant improvement in all parameters ( P chair test and Beck depression inventory . Week 24 evaluation results in group 2 showed significant improvements in pain and fatigue according to visual analogue scale ( VAS ) , 5-point scale , number of tender points , algometric and myalgic scores , and patient and physician global evaluation ( P morning stiffness , sleep , fibromyalgia impact question naire ( FIQ ) , chair test , and Beck depression inventory parameters in this group . Comparison of the two groups based on the post-treatment ( weeks 12 and 24 ) percent changes and difference scores relative to pretreatment ( week 0 ) values failed to show a significant difference between the groups for any parameter except Beck depression inventory ( P pool-based exercise had a longer-lasting effect on some of the FMS symptoms , but statistical analysis failed to show a significant superiority of pool-based exercise over balneotherapy without exercise . While we believe that exercise is a gold st and ard in FMS treatment , we also suggest in light of our results that balneotherapy is among the valid treatment options in FMS , and further research regarding the type and duration of the exercise programs is necessary",
"OBJECTIVE To evaluate the short- and long-term efficacy of exercise therapy in a warm , waist-high pool in women with fibromyalgia . METHODS Thirty-four women ( mean + /- SD tender points 17 + /- 1 ) were r and omly assigned to either an exercise group ( n = 17 ) to perform 3 weekly sessions of training including aerobic , proprioceptive , and strengthening exercises during 12 weeks , or to a control group ( n = 17 ) . Maximal unilateral isokinetic strength was measured in the knee extensors and flexors in concentric and eccentric actions at 60 degrees /second and 210 degrees /second , and in the shoulder abductors and adductors in concentric contractions . Health-related quality of life ( HRQOL ) was assessed using the EQ-5D question naire ; pain was assessed on a visual analog scale . All were measured at baseline , posttreatment , and after 6 months . RESULTS The strength of the knee extensors in concentric actions increased by 20 % in both limbs after the training period , and these improvements were maintained after the de-training period in the exercise group . The strength of other muscle actions measured did not change . HRQOL improved by 93 % ( P = 0.007 ) and pain was reduced by 29 % ( P = 0.012 ) in the exercise group during the training , but pain returned close to the pretraining level during the subsequent de-training . However , there were no changes in the control group during the entire period . CONCLUSION The therapy relieved pain and improved HRQOL and muscle strength in the lower limbs at low velocity in patients with initial low muscle strength and high number of tender points . Most of these improvements were maintained long term",
"OBJECTIVE To compare hydrotherapy ( HT ) and conventional physiotherapy ( CP ) in the treatment of fibromyalgia ( FM ) , regarding quality of life ( QOL ) , total sleep time ( TST ) , and total nap time ( TNT ) . METHODS Fifty out patients , all female , 30 - 60 years old , diagnosed with FM , were r and omly assigned to two groups to carry out 3 weeks of treatment with HT or CP . In the beginning and in the end of treatment , patients were evaluated with the SF-36 question naire to measure QOL and the sleep diary for TST and TNT . Data analyses were blind . RESULTS All 24 HT patients increased 1h in TST compared to 19 CP patients . TNT decreased in the HT group . QOL improved for the two groups in all domains when pre- and post-intervention were compared , but there was no difference between groups . CONCLUSION HT is more effective than CP to improve TST and to decrease TNT in FM patients",
"OBJECTIVES To compare the cognitive function performance in patients with fibromyalgia ( FM ) with respect healthy controls and to evaluate the short-term efficacy of exercise therapy in a warm , chest-high pool on pain and cognitive function in women with FM . METHODS Sixty middle-aged women with FM were r and omly assigned to either an exercise training group ( n = 35 ) to perform 3 sessions per week of aquatic training ( 32 degrees C ) including mobility , aerobic , strengthening , and relaxation exercises for 16 weeks , or a control group ( n = 25 ) . Twenty-five healthy women matched for age , weight , body mass index , and educational and physical activity levels were recruited . Pain was assessed in patients using a syringe calibrated like a pressure dolorimeter , and a visual analog scale . The severity of FM was evaluated using the Fibromyalgia Impact Question naire . Cognitive function was measured in healthy individuals and patients using several st and ardized neuropsychological tests . All patients were measured at baseline and post-treatment . RESULTS At baseline , the healthy group evidence d cognitive performance that was significantly superior to the group of patients with FM in all of the neuropsychological tests . The exercise group significantly improved their pain threshold , tender point count , self-reported pain , severity of FM , and cognitive function , while in the control group the differences were not significant . CONCLUSION An exercise therapy three times per week for 16 weeks in a warm-water pool is an adequate treatment to decrease the pain and severity of FM well as to improve cognitive function in previously unfit women with FM and heightened painful symptomatology",
"OBJECTIVE To compare the clinical effectiveness of aerobic exercise in the water with walking/jogging for women with fibromyalgia ( FM ) . METHODS Sixty sedentary women with FM , ages 18 - 60 years , were r and omly assigned to either deep water running ( DWR ) or l and -based exercises ( LBE ) . Patients were trained for 15 weeks at their anaerobic threshold . Visual analog scale of pain , Fibromyalgia Impact Question naire ( FIQ ) , Beck Depression Inventory , Short Form 36 Health Survey ( SF-36 ) , and a patient 's global assessment of response to therapy ( PGART ) were measured at baseline , week 8 , and week 15 . Statistical analysis included all patients . RESULTS Four patients dropped out from each group . Both groups improved significantly at week 15 compared with baseline , with an average 36 % reduction in pain intensity . For PGART , 40 % of the DWR group and 30 % of the LBE group answered \" much better \" at posttreatment . FIQ total score and FIQ depression improvements in the DWR group were faster ( week 8) than the LBE group and kept improving ( week 15 ; P improvements in SF-36 role emotional ( P = 0.006 ) . No significant between-group differences were observed for peak oxygen uptake and other outcomes . CONCLUSION DWR is a safe exercise that has been shown to be as effective as LBE regarding pain . However , it has been shown to bring more advantages related to emotional aspects . Aerobic gain was similar for both groups , regardless of symptom improvement . Therefore , DWR could be studied as an exercise option for patients with FM who have problems adapting to LBE or lower limbs limitations",
"OBJECTIVE To evaluate the effect of exercise on mood and physical function in individuals with fibromyalgia . METHODS Subjects were r and omly assigned to an exercise ( EX ) or control ( CTL ) group . EX subjects participated in 3 30-minute exercise classes per week for 23 weeks . Subjects were tested at entry and at 6 , 12 , and 23 weeks . Tests included the Beck Depression Inventory ( BDI ) , 6-minute walk , State-Trait Anxiety Inventory ( STAI ) , Mental Health Inventory ( MHI ) , Fibromyalgia Impact Question naire ( FIQ ) , Arthritis Self-Efficacy Scale ( ASES ) , and a measure of tender points and knee strength . RESULTS Fifty subjects ( 27 EX , 23 CTL ) completed the study , and 31 ( 15 EX , 16 CTL ) met criteria for efficacy analyses . In efficacy analyses , significant improvements were seen for EX subjects in 6-minute walk distances , BDI ( total , cognitive/ affective ) , STAI , FIQ , ASES , and MHI ( 3 of 5 subscales ) scores . These effects were reduced but remained during intent-to-treat analyses . CONCLUSION Exercise can improve the mood and physical function of individuals with fibromyalgia",
"PURPOSE To evaluate the effects of a 12-wk period of aquatic training and subsequent detraining on health-related quality of life ( HRQOL ) and physical fitness in females with fibromyalgia . METHODS Thirty-four females with fibromyalgia were r and omly assigned into two groups : an exercise group , who exercised for 60 min in warm water , three times a week ( N = 17 ) ; and a control group , who continued their habitual leisure-time activities ( N = 17 ) . HRQOL was assessed using the Short Form 36 question naire and the Fibromyalgia Impact Question naire . Physical fitness was measured using the following tests : Canadian Aerobic Fitness , h and grip dynamometry , 10-m walking , 10-step stair climbing , and blind one-leg stance . Outcomes were measured at baseline , after treatment , and after 3 months of detraining . RESULTS After 12 wk of aquatic exercise , significant positive effects of aquatic training were found in physical function , body pain , general health perception , vitality , social function , role emotional problems and mental health , balance , and stair climbing . After the detraining period , only the improvements in body pain and role emotional problems were maintained . CONCLUSION The present water exercise protocol improved some components of HRQOL , balance , and stair climbing in females with fibromyalgia , but regular exercise and higher intensities may be required to preserve most of these gains",
"OBJECTIVE To evaluate whether changes in muscle strength due to 32 weeks of supervised aquatic training predicted improvements on health-related quality of life ( HRQOL ) . METHODS Thirty women with FM aged 50.8 + /- 8.7 years were r and omly assigned to an experimental group ( n = 15 ) , performing 3 weekly sessions of 60 min of warm-water exercise ; or to a control group ( n = 15 ) . HRQOL was evaluated using the Short Form 36 Health Survey ( SF-36 ) . Maximal unilateral isokinetic strength was measured at 60 degrees/s and 210 degrees/s in the knee extensors and flexors in concentric action and at 60 degrees/s in knee extensors eccentric action . Postural balance was evaluated using the one-leg stance , eyes closed . RESULTS After 32 weeks of water exercise therapy , statistically significant improvements occurred in concentric knee flexors and extensors strength at 60 degrees/s , in eccentric knee extensors and in postural balance . The treatment led to additional improvements in physical function , role physical problems , body pain , general health , vitality , role emotional problems and mental health dimensions of SF-36 . Gains in the concentric knee flexors strength predicted improvements in role of physical problems , whereas those in concentric knee extensors did the same for mental health and role emotional problems . Gains in eccentric knee extensors strength predicted improvements in postural balance . CONCLUSIONS A long-lasting exercise therapy in warm water produced relevant gains in muscle strength at low velocities of movements , some of which predicted improvements in physical problems , emotional problems , mental health and balance . TRIAL REGISTRATION International St and ard R and omized Controlled Trial Number IS RCT N53367487 , information available in http://www.controlled-trials.com/IS RCT N53367487",
"The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . To encourage dissemination of the CONSORT 2010 Statement , this article is freely accessible on bmj.com and will also be published in the Lancet , Obstetrics and Gynecology , PLoS Medicine , Annals of Internal Medicine , Open Medicine , Journal of Clinical Epidemiology , BMC Medicine , and Trials"
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Given accumulating evidence indicating that acute and chronic physical activity and cardiorespiratory fitness are related to modulation of the P3b-ERP component , this systematic review provides an overview of the field across the last 30 + years and discusses future directions as the field continues to develop . A systematic review was conducted on studies of physical activity and cardiorespiratory fitness on P3b . PubMed , Web of Science , and Scopus were search ed from data base inception to March 28 , 2018 . Search results were limited to peer- review ed and English-written studies investigating typically developed individuals . Seventy-two studies were selected , with 39 studies examining cross-sectional relationships between chronic physical activity ( n = 19 ) and cardiorespiratory fitness ( n = 20 ) with P3b , with 16 and 17 studies reporting associations of P3b with physical activity and cardiorespiratory fitness , respectively . Eight studies investigated the effects of chronic physical activity interventions , and all found effects on P3b . Eight studies investigating P3b during acute bouts of physical activity showed inconsistent results . Nineteen of 23 studies demonstrated acute modulation of P3b following exercise cessation . Conclusions drawn from this systematic review suggest that physical activity and cardiorespiratory fitness are associated with P3b modulation during cognitive control and attention tasks . Acute and chronic physical activity interventions modulate the P3b component , suggesting short- and long-term functional adaptations occurring in the brain to support cognitive processes . These summary findings suggest physical activity and cardiorespiratory fitness are beneficial to brain function and that P3b may serve as a biomarker of covert attentional processes to better underst and the relationship of physical activity and cognition
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"To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results",
"OBJECTIVE : To assess the effect of a physical activity ( PA ) intervention on brain and behavioral indices of executive control in preadolescent children . METHODS : Two hundred twenty-one children ( 7–9 years ) were r and omly assigned to a 9-month afterschool PA program or a wait-list control . In addition to changes in fitness ( maximal oxygen consumption ) , electrical activity in the brain ( P3-ERP ) and behavioral measures ( accuracy , reaction time ) of executive control were collected by using tasks that modulated attentional inhibition and cognitive flexibility . RESULTS : Fitness improved more among intervention participants from pretest to posttest compared with the wait-list control ( 1.3 mL/kg per minute , 95 % confidence interval [ CI ] : 0.3 to 2.4 ; d = 0.34 for group difference in pre-to-post change score ) . Intervention participants exhibited greater improvements from pretest to posttest in inhibition ( 3.2 % , 95 % CI : 0.0 to 6.5 ; d = 0.27 ) and cognitive flexibility ( 4.8 % , 95 % CI : 1.1 to 8.4 ; d = 0.35 for group difference in pre-to-post change score ) compared with control . Only the intervention group increased attentional re sources from pretest to posttest during tasks requiring increased inhibition ( 1.4 µV , 95 % CI : 0.3 to 2.6 ; d = 0.34 ) and cognitive flexibility ( 1.5 µV , 95 % CI : 0.6 to 2.5 ; d = 0.43 ) . Finally , improvements in brain function on the inhibition task ( r = 0.22 ) and performance on the flexibility task correlated with intervention attendance ( r = 0.24 ) . CONCLUSIONS : The intervention enhanced cognitive performance and brain function during tasks requiring greater executive control . These findings demonstrate a causal effect of a PA program on executive control , and provide support for PA for improving childhood cognition and brain health",
"The purpose of this study was to investigate the effect of moderate strength and endurance training on cognition evaluated by event-related potentials ( ERP ) in older people . Thirty-six adults , aged 60 - 85 years , were r and omly divided into three groups : sedentary control ( C ) , strength training ( ST ) , and endurance training ( ET ) . Participants performed functional fitness tests and ERP data were recorded before and after nine weeks of training . Training involved three sessions per week . Functional fitness test performance improved significantly in the ST and ET groups . The latencies of the N1 , N2 , and P2 components and the amplitudes of the N1P2 , P2N2 , and N2P3 components differed significantly between groups ( p latencies of the P2 and N2 components at the Fz and Cz sites , decreased significantly , and the amplitudes of the N1P2 , P2N2 , and N2P3 components at the Fz site and the N1P2 and N2P3 components at the Cz site , increased significantly in the ST group compared with the ET group . After training , the latencies of N1 , N2 , and P2 components shortened significantly , and the amplitudes of the N1P2 , P2N2 , and N2P3 components increased significantly in the ST group compared with the C group . The latencies of the N2 and P2 components shortened significantly in the ET group compared with the C group , although the amplitudes of the ERP recordings did not differ significantly between groups . These data suggest that strength training might facilitate early sensory processing and cognitive functioning in older individuals . Key PointsStrength training may have facilitating effects on early information processing and cognition in older people . It is interesting that only small improvements in functional fitness affected cognitive performance . More research is needed to determine how the different exercise regimens contribute to discrete changes in CNS functioning and how such changes affect the P3 component of the ERP",
"Importance Objective physical fitness measures , such as h and grip strength , are associated with physical , mental , and cognitive outcomes in the general population . Although people with mental illness experience reduced physical fitness and cognitive impairment , the association between muscular strength and cognition has not been examined to date . Objective To determine associations between maximal h and grip strength and cognitive performance in people with major depression or bipolar disorder and in healthy controls . Design , Setting , and Participants In a multicenter , population -based study conducted between February 13 , 2005 , and October 1 , 2010 , in the United Kingdom , cross-sectional analysis was conducted of baseline data from 110 067 participants in the UK Biobank . Data analysis was performed between August 3 and August 18 , 2017 . Invitations were mailed to approximately 9.2 million UK homes , recruiting 502 664 adults , all aged 37 to 73 years . Clinical ly vali date d measures were used to identify individuals with major recurrent depression ( moderate or severe ) or bipolar disorder ( type I or type II ) and healthy controls ( those with no indication of present or previous mood disorders ) . Main Outcomes and Measures H and grip dynamometry was used to measure muscular function . Cognitive functioning was assessed using computerized tasks of reaction time , visual memory , number memory , reasoning , and prospect i ve memory . Generalized linear mixed models assessed the association between h and grip strength and cognitive performance , controlling for age , educational level , sex , body weight , and geographic region . Results Of the 110 067 participants , analyses included 22 699 individuals with major depression ( mean [ 95 % range ] age , 55.5 [ 41 - 68 ] years ; 7936 [ 35.0 % ] men ) , 1475 with bipolar disorder ( age , 54.4 [ 41 - 68 ] years ; 748 [ 50.7 % ] men ) , and 85 893 healthy controls ( age , 53.7 [ 41 - 69 ] years ; 43 000 [ 50.0 % ] men ) . In those with major depression , significant positive associations ( P maximal h and grip strength and improved performance on all 5 cognitive tasks were found , including visual memory ( coefficient , −0.146 ; SE , 0.014 ) , reaction time ( coefficient , −0.036 ; SE , 0.002 ) , reasoning ( coefficient , 0.213 ; SE , 0.02 ) , number memory ( coefficient , 0.160 ; SE , 0.023 ) , and prospect i ve memory ( coefficient , 0.341 ; SE , 0.024 ) . Similar results were found in healthy controls . Among participants with bipolar disorder , h and grip strength was positively associated with improved visual memory ( coefficient , −0.129 ; SE , 0.052 ; P = .01 ) , reaction time ( coefficient , −0.047 ; SE , 0.007 ; P .001 ) , prospect i ve memory ( coefficient , 0.262 ; SE , 0.088 ; P = .003 ) , and reasoning ( coefficient , 0.354 ; SE , 0.08 ; P people with major depression and bipolar disorder . Future research should investigate causality , assess the functional implication s of h and grip strength in psychiatric population s , and examine how interventions to improve muscular fitness affect neurocognitive status and socio-occupational functioning",
"Acute bouts of aerobic physical exercise can modulate subsequent cognitive task performance and oscillatory brain activity measured with electroencephalography ( EEG ) . Here , we investigated the sequencing of these modulations of perceptual and cognitive processes using scalp recorded EEG acquired during exercise . Twelve participants viewed pseudo-r and om sequences of frequent non-target stimuli ( cars ) , infrequent distractors ( obliquely oriented faces ) and infrequent targets that required a simple detection response ( obliquely oriented faces , where the angle was different than the infrequent distractors ) . The sequences were presented while seated on a stationary bike under three conditions during which scalp recorded EEG was also acquired : rest , low-intensity exercise , and high-intensity exercise . Behavioral target detection was faster during high-intensity exercise compared to both rest and low-intensity exercise . An event-related potential ( ERP ) analysis of the EEG data revealed that the mean amplitude of the visual P1 component evoked by frequent non-targets measured at parietal-occipital electrodes was larger during low-intensity exercise compared to rest . The P1 component evoked by infrequent targets also peaked earlier during low-intensity exercise compared to rest and high-intensity exercise . The P3a ERP component evoked by infrequent distractors measured at parietal electrodes peaked significantly earlier during both low- and high-intensity exercise when compared to rest . The modulation of the visual P1 and the later P3a components is consistent with the conclusion that exercise modulates multiple stages of neural information processing , ranging from early stage sensory processing ( P1 ) to post-perceptual target categorization ( P3a )",
"Recently , virtual environments ( VEs ) are suggested to encourage users to exercise regularly . The benefits of chronic exercise on cognitive performance are well documented in non-VE neurophysiological and behavioural studies . Based on event-related potentials ( ERP ) such as the N200 and P300 , cognitive processing may be interpreted on a neuronal level . However , exercise-related neuroelectric adaptation in VE remains widely unclear and thus characterizes the primary aim of the present study . Twenty-two healthy participants performed active ( moderate cycling exercise ) and passive ( no exercise ) sessions in three VEs ( control , front , surround ) , each generating a different sense of presence . Within sessions , conditions were r and omly assigned , each lasting 5 min and including a choice reaction-time task to assess cognitive performance . According to the international 10:20 system , EEG with real-time triggered stimulus onset was recorded , and peaks of N200 and P300 components ( amplitude , latency ) were exported for analysis . Heart rate was recorded , and sense of presence assessed prior to and following each session and condition . Results revealed an increase in ERP amplitudes ( N200 : p 0.001 ) and latencies ( N200 : p sense of presence ( p ERP were not modulated by exercise ( each p > 0.05 ) . Hypothesized to mirror cognitive processing , decreases of cognitive performance ’s accuracy and reaction time failed significance . With respect to previous research , the present neuroelectric adaptation gives reason to believe in compensative neuronal re sources that balance dem and ing cognitive processing in VE to avoid behavioural inefficiency",
" Older and younger aerobically trained and sedentary adults participated in an S1-S2-S3 paradigm design ed to elicit event-related potential ( ERP ) and behavioral responses to determine the influence of cardiovascular fitness on cognitive and motor processes . The paradigm provided warning ( S1 ) as to the difficulty level of an upcoming decision task ( S2 ) . Participants had to decide the taller of two bars on presentation of S2 but hold their response until S3 , to which they indicated their choice motorically . Results revealed age-related differences for ERP measures as older participants showed increased amplitude of the stimulus preceding negativity ( SPN ) prior to S2 , and longer latencies and equipotentiality of P3 in response to S2 . Fitness effects were also observed for the contingent negative variation ( CNV ) with decreased amplitude for fit relative to sedentary individuals . Age interacted with fitness for P3 latency to S2 as older sedentary individuals showed the longest latency followed by older fit and both younger groups . No significant group differences were observed for reaction time ( RT ) to S3 . Therefore , physical fitness is associated with attenuation of cognitive decline in older individuals and greater economy of motor preparation for both young and older participants",
"This study had the following two aims : First , to explore the effects of acute resistance exercise ( RE , i.e. , using exercise machines to contract and stretch muscles ) on behavioral and electrophysiological performance when performing a cognitive task involving executive functioning in young male adults ; Second , to investigate the potential biochemical mechanisms of such facilitative effects using two neurotrophic factors [ i.e. , growth hormone ( GH ) and insulin-like growth factor-1 ( IGF-1 ) ] and the cortisol levels elicited by such an exercise intervention mode with two different exercise intensities . Sixty young male adults were recruited and r and omly assigned to a high-intensity ( HI ) exercise group , moderate-intensity ( MI ) exercise group , and non-exercise-intervention ( NEI ) group . Blood sample s were taken , and the behavioral and electrophysiological indices were simultaneously measured when individuals performed a Go/No-Go task combined with the Erikson Flanker paradigm at baseline and after either an acute bout of 30 min of moderate- or high-intensity RE or a control period . The results showed that the acute RE could not only benefit the subjects ' behavioral ( i.e. , RTs and accuracy ) performance , as found in previous studies , but also increase the P3 amplitude . Although the serum GH and IGF-1 levels were significantly increased via moderate or high intensity RE in both the MI and HI groups , the increased serum levels of neurotrophic factors were significantly decreased about 20 min after exercise . In addition , such changes were not correlated with the changes in cognitive ( i.e. , behavioral and electrophysiological ) performance . In contrast , the serum levels of cortisol in the HI and MI groups were significantly lower after acute RE , and the changes in cortisol levels were significantly associated with the changes in electrophysiological ( i.e. , P3 amplitude ) performance . The findings suggest the beneficial effects of acute RE on executive functioning could be due to changes in arousal , possibly modulated by the serum cortisol levels",
"This study aim ed to explore the effects of open- and closed-skill exercise interventions on the neurocognitive performance of executive functions in the elderly . Sixty-four healthy elderly males were r and omly assigned to either a closed-skill ( bike riding or brisk walking/jogging , n = 22 ) , open-skill ( table tennis , n = 21 ) , or control ( n = 21 ) group . Various neuropsychological [ e.g. , accuracy rates ( AR ) and reaction time ( RT ) ] and electrophysiological [ e.g. , event-related potential ( ERP ) P3 component ] measures were assessed during a variant of the task-switching paradigm , as well as an N-back task at baseline and after either a 6-month exercise intervention or control period . The results showed that , when performing the task-switching paradigm , the two exercise groups relative to control group showed significantly faster RTs in the switch trials after the exercise intervention . However , the RT facilitation in the non-switch and switch trials post-exercise relative to pre-exercise only emerged in the open-skill group . In terms of the N-back task , the two exercise groups significantly increased ARs in the 1-back condition after the exercise intervention , and the beneficial AR effect on the 2-back condition only emerged in the closed-skill group . In addition , the two exercise groups exhibited significantly larger P3 amplitudes on the frontal-to-parietal cortex areas after the exercise intervention relative to the baseline when performing the two cognitive tasks . These neurocognitive results still remained unchanged even when the confounding factors ( e.g. , cardiorespiratory fitness , social participation , and BMI ) were controlled for . The present study concluded that , although 6-month open- and closed-skill exercise interventions facilitate overall electrophysiological effects ( i.e. , increased ERP P3 amplitudes ) on the frontal-to-parietal cortices in the elderly , the two exercise modes produced different levels of neuropsychologically beneficial effects on RTs of the task-switching paradigm ( i.e. , lessened RTs ) and ARs of the N-back task ( i.e. , enhanced ARs ) . The distinctive neurocognitive changes induced by open- and closed-skill exercise have implication s for task switching and working memory in elderly individuals , especially with such cognitive functioning impairments",
"The influence of exercise intensity on information processing in the central nervous system was investigated using P300 and no-go P300 event-related potentials . Twelve subjects ( 22–33 years ) performed a go/no-go reaction time task in a control condition , and again after high- , medium- , and low-intensity pedaling exercises . Compared to the control condition , P300 amplitude decreased after high-intensity pedaling exercise and increased after medium-intensity pedaling exercise . There was no change after low-intensity pedaling exercise . These results suggested that the amount of attentional re sources devoted to a given task decreased after high-intensity exercise and increased after medium-intensity exercise . The findings also suggest that changes in P300 amplitude are an inverted U-shaped behavior of differences in exercise intensity . In addition , no-go P300 amplitude showed the same changes as P300 amplitude at different exercise intensities . This indicates that differences in exercise intensity influenced not only the intensity of processing the requirement for a go response , but also processing of the need for a no-go response . It is concluded that differences in exercise intensity influenced information processing in the CNS",
"Abstract Background : We report the first controlled study of Tai Chi effects on the P300 event-related potential , a neuroelectric index of human executive function . Tai Chi is a form of exercise and moving meditation . Exercise and meditation have been associated with enhanced executive function . This cross-sectional , controlled study utilized the P300 event-related potential ( ERP ) to compare executive network neural function between self-selected long-term Tai Chi , meditation , aerobic fitness , and sedentary groups . We hypothesized that because Tai Chi requires moderate aerobic and mental exertion , this group would show similar or better executive neural function compared to meditation and aerobic exercise groups . We predicted all health training groups would outperform sedentary controls . Methods : Fifty-four volunteers ( Tai Chi , n=10 ; meditation , n=16 ; aerobic exercise , n=16 ; sedentary , n=12 ) were tested with the Rockport 1-mile walk ( estimated VO2 Max ) , a well-vali date d measure of aerobic capacity , and an ecologically valid visuo-spatial , r and omized , alternating runs Task Switch test during dense-array electroencephalographic ( EEG ) recording . Results : Only Tai Chi and meditation plus exercise groups demonstrated larger P3b ERP switch trial amplitudes compared to sedentary controls . Conclusions : Our results suggest long-term Tai Chi practice , and meditation plus exercise may benefit the neural substrates of executive function",
"Electrophysiological effects of aerobic fitness and maximal aerobic exercise were investigated by comparing P300 and N400 before and after a maximal cycling test . Event-related potentials ( ERPs ) were obtained from 20 students divided into two matched groups defined by their aerobic fitness level ( cyclists vs. sedentary subjects ) . The session of postexercise ERPs was performed immediately after body temperature and heart rate returned to preexercise values . At rest , no significant differences were observed in ERP parameters between cyclists and sedentary subjects . This finding argued against the hypothesis that ERP modifications may be directly assumed by aerobic fitness level . The postexercise session of ERPs showed a significant P300 amplitude increase and a significant P300 latency decrease in all subjects . Similarly , N400 effect increased significantly after the maximal exercise in all subjects . ERP changes were of the same magnitude in the two groups . The present study argues for a general arousing effect of maximal aerobic exercise , independently of the aerobic fitness level",
"OBJECTIVES To examine the effects of a structured exercise program implemented during school break-time on working memory maintenance and neurophysiological indices of task preparation processes in adolescents . DESIGN Using class-wise r and om allocation , participants from four classes were divided into an exercise ( n=20 ) and a wait-list control group ( n=16 ) . Over a period of eight weeks , the exercise group engaged in 20min of combined aerobic and coordinative exercise on each school day . METHODS Prior to and after the intervention period , participants performed a computer-based Sternberg task for the assessment of working memory performance . Simultaneously , the contingent negative variation ( CNV ) of event-related potentials was measured . RESULTS The exercise group demonstrated a larger decrease in reaction time from pre- to post-test relative to the control group , F(1 , 31)=13.5 , p accuracy on the Sternberg task across groups . Using cluster-based permutation testing , the analysis of event-related potentials revealed a significant increase of the initial CNV from pre- to post-test in the exercise group , cluster value=-2376.2 , p=0.006 , which was most pronounced for the fronto- central region , with no such effect observed for the control group . CONCLUSIONS Daily engagement in a short combined aerobic and coordinative exercise program following the school lunch time break elicits benefits for working memory in adolescents . These changes are accompanied by improvements of task preparation processes , which allow the selection of a more appropriate cognitive control strategy",
"Objective We investigated the effects of six months vitamin E administration on cognition evaluated by event-related potentials in exercising older subjects . Design R and omised controlled trial . Setting Retirement home in Antalya , Turkey . Participants Fifty-seven adults aged 60–85 years were r and omly assigned to one of four groups : sedentary control ( C ) , vitamin E ( V ) , exercise training ( E ) and vitamin E under training (EV).InterventionV and EV groups were received vitamin E at a dose of 900 IU/day P.O. for 6 months . Trained groups were subjected to walking exercise involved 3 sessions per week for 6 months . Walking duration was gradually increased during 8 weeks , and stayed constant until the end of training period . Participants were begun walking at % 70 heart rate reserve for 20 min/day at the first two weeks , and walking duration was increased by 5 minutes/day of each week until subjects were reached a level of 50 min/day by week 8 . Measurements Plasma vitamin E concentration , total antioxidant capacity and two parameters of event-related potentials namely P3 latency and amplitude were performed on all study groups both before and after training . Results Significant improvement in P3 latency was found in exercising groups . However , no significant differences were found between vitamin and other groups for P3 latency . Amplitude measurements were found unaltered among all groups . Conclusion We concluded that although six months training results improvement in P3 latency , vitamin E supplementation does not affect cognitive function evaluated by event-related potentials in older subjects"
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Background The clinical effectiveness of intensive lifestyle interventions in preventing or delaying diabetes in people at high risk has been established from r and omised trials of structured , intensive interventions conducted in several countries over the past two decades . The challenge is to translate them into routine clinical setting s. The objective of this review is to determine whether lifestyle interventions delivered to high-risk adult patients in routine clinical care setting s are feasible and effective in achieving reductions in risk factors for diabetes . Methods Data sources : MEDLINE ( PubMed ) , EMBASE , CINAHL , The Cochrane Library , Google Scholar , and grey literature were search ed for English- language articles published from January 1990 to August 2009 . The reference lists of all articles collected were checked to ensure that no relevant suitable studies were missed . Study selection : We included RCTs , before/after evaluations , cohort studies with or without a control group and interrupted time series analyses of lifestyle interventions with the stated aim of diabetes risk reduction or diabetes prevention , conducted in routine clinical setting s and delivered by healthcare providers such as family physicians , practice nurses , allied health personnel , or other healthcare staff associated with a health service . Outcomes of interest were weight loss , reduction in waist circumference , improvement of impaired fasting glucose or oral glucose tolerance test ( OGTT ) results , improvements in fat and fibre intakes , increased level of engagement in physical activity and reduction in diabetes incidence . Results Twelve from 41 potentially relevant studies were included in the review . Four studies were suitable for meta- analysis . A significant positive effect of the interventions on weight was reported by all study types . The meta- analysis showed that lifestyle interventions achieved weight and waist circumference reductions after one year . However , no clear effects on biochemical or clinical parameters were observed , possibly due to short follow-up periods or lack of power of the studies meta-analysed . Changes in dietary parameters or physical activity were generally not reported . Most studies assessing feasibility were supportive of implementation of lifestyle interventions in routine clinical care . Conclusion Lifestyle interventions for patients at high risk of diabetes , delivered by a variety of healthcare providers in routine clinical setting s , are feasible but appear to be of limited clinical benefit one year after intervention . Despite convincing evidence from structured intensive trials , this systematic review showed that translation into routine practice has less effect on diabetes risk reduction
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"BACKGROUND AND OBJECTIVE To develop a checklist of items measuring the quality of reports of r and omized clinical trials ( RCTs ) assessing nonpharmacological treatments ( NPTs ) . STUDY DESIGN AND SETTING The Delphi consensus method was used to select and reduce the number of items in the checklist . A total of 154 individuals were invited to participate : epidemiologists and statisticians involved in the field of methodology of RCTs ( n = 55 ) , members of the Cochrane Collaboration ( n = 41 ) , and clinicians involved in planning NPT clinical trials ( n = 58 ) . Participants ranked on a 10-point Likert scale whether an item should be included in the checklist . RESULTS Fifty-five experts ( 36 % ) participated in the survey . They were experienced in systematic review s ( 68 % were involved in the Cochrane Collaboration ) and in planning RCTs ( 76 % ) . Three rounds of the Delphi method were conducted to achieve consensus . The final checklist contains 10 items and 5 subitems , with items related to the st and ardization of the intervention , care provider influence , and additional measures to minimize the potential bias from lack of blinding of participants , care providers , and outcome assessors . CONCLUSIONS This tool can be used to critically appraise the medical literature , design NPT studies , and assess the quality of trial reports included in systematic review",
"Background R and omised controlled trials demonstrate a 60 % reduction in type 2 diabetes incidence through lifestyle modification programmes . The aim of this study is to determine whether such programmes are feasible in primary health care . Methods An intervention study including 237 individuals 40–75 years of age with moderate or high risk of developing type 2 diabetes . A structured group programme with six 90 minute sessions delivered during an eight month period by trained nurses in Australian primary health care in 2004–2006 . Main outcome measures taken at baseline , three , and 12 months included weight , height , waist circumference , fasting plasma glucose and lipids , plasma glucose two hours after oral glucose challenge , blood pressure , measures of psychological distress and general health outcomes . To test differences between baseline and follow-up , paired t-tests and Wilcoxon rank sum tests were performed . Results At twelve months participants ' mean weight reduced by 2.52 kg ( 95 % confidence interval 1.85 to 3.19 ) and waist circumference by 4.17 cm ( 3.48 to 4.87 ) . Mean fasting glucose reduced by 0.14 mmol/l ( 0.07 to 0.20 ) , plasma glucose two hours after oral glucose challenge by 0.58 mmol/l ( 0.36 to 0.79 ) , total cholesterol by 0.29 mmol/l ( 0.18 to 0.40 ) , low density lipoprotein cholesterol by 0.25 mmol/l ( 0.16 to 0.34 ) , triglycerides by 0.15 mmol/l ( 0.05 to 0.24 ) and diastolic blood pressure by 2.14 mmHg ( 0.94 to 3.33 ) . Significant improvements were also found in most psychological measures . Conclusion This study provides evidence that a type 2 diabetes prevention programme using lifestyle intervention is feasible in primary health care setting s , with reductions in risk factors approaching those observed in clinical trials . Trial NumberCurrent Controlled Trials IS RCT",
"Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design",
"D iabetes is one of the most costly and burdensome chronic diseases of our time and is a condition that is increasing in epidemic proportions in the U.S. and throughout the world ( 1 ) . The complications result ing from the disease are a significant cause of morbidity and mortality and are associated with the damage or failure of various organs such as the eyes , kidneys , and nerves . Individuals with type 2 diabetes are also at a significantly higher risk for coronary heart disease , peripheral vascular disease , and stroke , and they have a greater likelihood of having hypertension , dyslipidemia , and obesity ( 2–6 ) . There is also growing evidence that at glucose levels above normal but below the diabetes threshold diagnostic now referred to as pre-diabetes , there is a substantially increased risk of cardiovascular disease ( CVD ) and death ( 5,7–10 ) . In these individuals , CVD risk factors are also more prevalent ( 5–7,9,11–14 ) , which further increases the risk but is not sufficient to totally explain it . In contrast to the clear benefit of glucose lowering to prevent or retard the progression of microvascular complications associated with diabetes ( 15– 18,21 ) , it is less clear whether the high rate of CVD in people with impaired glucose homeostasis , i.e. , those with impaired fasting glucose ( IFG ) , impaired glucose tolerance ( IGT ) , or diabetes , is caused by elevated blood glucose levels or will respond to treatments that lower blood glucose . Epidemiological studies have shown a clear relationship ( 19,20 ) , whereas intervention trials in people with diabetes suggest , but have not demonstrated , a clear benefit of glycemic control ( 15,16,21,22 ) . Additionally , there are no studies that have investigated a benefit of glucose lowering on macrovascular disease in subjects with only pre-diabetes ( IFG or IGT ) but not diabetes . Although the treatment of diabetes has become increasingly sophisticated , with over a dozen pharmacological agents available to lower blood glucose , a multitude of ancillary supplies and equipment available , and a clear recognition by health care professionals and patients that diabetes is a serious disease , the normalization of blood glucose for any appreciable period of time is seldom achieved ( 23 ) . In addition , in well-controlled socalled “ intensively ” treated patients , serious complications still occur ( 15–18,21 ) , and the economic and personal burden of diabetes remains . Furthermore , microvascular disease is already present in many individuals with undiagnosed or newly diagnosed type 2 diabetes ( 11,24– 28 ) . Given these facts , it is not surprising that studies have been initiated in the last decade to determine the feasibility and benefit of various strategies to prevent or delay the onset of type 2 diabetes . Two early reports ( 29,30 ) suggested that changes in lifestyle can prevent diabetes , but weaknesses in study design limited their general relevance . Recently , however , four well- design ed r and omized controlled trials have been reported ( 31–35 ) . In the Finnish study ( 31 ) , 522 middleaged ( mean age 55 years ) obese ( mean BMI 31 kg/m ) subjects with IGT were r and omized to receive either brief diet and exercise counseling ( control group ) or intensive individualized instruction on weight reduction , food intake , and guidance on increasing physical activity ( intervention group ) . After an average follow-up of 3.2 years , there was a 58 % relative reduction in the incidence of diabetes in the intervention group compared with the control subjects . A strong correlation was also seen between the ability to stop the progression to diabetes and the degree to which subjects were able to achieve one or more of the following : lose weight ( goal of 5.0 % weight reduction ) , reduce fat intake ( goal of 30 % of calories ) , reduce saturated fat intake ( goal of 10 % of calories ) , increase fiber intake ( goal of 15 g/1,000 kcal ) , and exercise ( goal of 150 min/week ) . No untoward effects of the lifestyle interventions were observed . In the Diabetes Prevention Program ( DPP ) ( 32–34 ) , the 3,234 enrolled subjects were slightly younger ( mean age 51 years ) and more obese ( mean BMI 34 kg/m ) but had nearly identical glucose intolerance compared with subjects in the Finnish study . About 45 % of the participants were from minority groups ( e.g , AfricanAmerican , Hispanic ) , and 20 % were 60 years of age . Subjects were r and omized to one of three intervention groups , which included the intensive nutrition and exercise counseling ( “ lifestyle ” ) group or either of two masked medication treatment groups : the biguanide metformin group or the placebo group . The latter interventions were combined with st and ard diet and exercise recommendations . After an average follow-up of 2.8 years ( range 1.8–4.6 years ) , a 58 % relative reduction in the progression to diabetes was observed in the lifestyle group ( absolute incidence 4.8 % ) , and a 31 % relative reduction in the progression of diabetes was observed in the metformin group ( absolute incidence 7.8 % ) compared with control subjects ( absolute incidence 11.0 % ) . ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●",
"The YMCA ’s Diabetes Prevention Program gives you the skills you need and the support you deserve to make lasting healthy lifestyle changes . WHAT IS PREDIABETES ? Prediabetes occurs when blood sugar levels are higher than normal but not high enough for a type 2 diabetes diagnosis . Risk for developing type 2 diabetes may be reduced or eliminated by weight loss , healthier eating and increased physical activity",
"Prevention of type 2 diabetes by intensive lifestyle intervention design ed to achieve and maintain ideal body weight was assessed in subjects with impaired glucose tolerance ( IGT ) . Male subjects with IGT recruited from health-screening examinees were r and omly assigned in a 4:1 ratio to a st and ard intervention group ( control group ) and intensive intervention group ( intervention group ) . The final numbers of subjects were 356 and 102 , respectively . The subjects in the control group and in the intervention group were advised to maintain body mass index ( BMI ) of 24.0 kg/m2 and of , respectively , by diet and exercise . In the intervention group , detailed instructions on lifestyle were repeated every 3 - 4 months during hospital visits . Diabetes was judged to have developed when two or more consecutive fasting plasma glucose ( FPG ) values exceeded 140 mg/dl . A 100 g oral glucose tolerance test was performed every 6 months to detect improvement of glucose tolerance . The subjects were seen in an ordinary outpatient clinic . The cumulative 4-year incidence of diabetes was 9.3 % in the control group , versus 3.0 % in the intervention group , and the reduction in risk of diabetes was 67.4 % ( P Body weight decreased by 0.39 kg in the control group and by 2.18 kg in the intervention group ( P decrease in body weight . The incidence of diabetes was positively correlated with the changes in body weight , and the improvement in glucose tolerance was negatively correlated . Subjects with higher FPG at baseline developed diabetes at a higher rate than those with lower FPG . Higher 2h plasma glucose values and higher BMI values at baseline were also associated with a higher incidence of diabetes , but the differences were not significant . Subjects with a low insulinogenic index ( DeltaIRI/DeltaPG 30 min after an oral glucose load ) developed diabetes at a significantly higher rate than those with a normal insulinogenic index . Comparison of the BMI data and incidence of diabetes in five diabetes prevention studies by lifestyle intervention revealed a linear correlation between the incidence of diabetes and the BMI values , with the exception of the DaQing Study . However , the slope of the reduction in incidence of diabetes in the intensive intervention groups was steeper than expected simply on the basis of the reduction of BMI , suggesting that the effect of lifestyle intervention can not be solely ascribed to the body weight reduction . We conclude that lifestyle intervention aim ed at achieving ideal body weight in men with IGT is effective and can be conducted in an outpatient clinic setting",
"OBJECTIVE The aim of this study was to assess the effectiveness of a new dietary education ( NDE ) program in reducing plasma glucose ( PG ) levels in Japanese male workers at high risk for type 2 diabetes through a r and omized controlled trial . RESEARCH DESIGN AND METHODS We r and omly assigned 173 high-risk men ( mean age , 55 years ) to either the NDE or the control ( conventional dietary education ) group . Each subject in the NDE group received two individualized interventions especially aim ed at reducing total energy intake at dinner by modifying dietary intake . The control group received conventional group counseling . An \" overintake/underintake fraction \" for total energy intake was used to measure the status of dietary intake . Our hypothesis was that the NDE group would have a 10 % decrease in 2-h PG 1 year after the start of the education . Outcome measures were compared with ANCOVA by adjusting for baseline values . RESULTS The NDE group had a significantly lower total energy intake at dinner and daily than the control group . The adjusted differences in changes from baseline in the absolute value of the ' overintake/underintake fraction ' were -15.3 % ( 95 % CI -24.6 to -6.0 % , P = 0.002 ) for dinner and -6.0 % ( -9.8 to -2.2 % , P = 0.002 ) for daily [ corrected ] . The NDE group had a decreased 2-h PG after 1 year , whereas that value was increased in the control group . The adjusted difference in the percent change of 2-h PG was significant ( -15.2 % , -22.0 to -8.4 % , P glucose levels in high-risk subjects for type 2 diabetes ",
"BACKGROUND Current cancer prevention recommendations include reducing consumption of fat and increasing consumption of fruits and vegetables . METHODS Healthy women health maintenance organization members ( n = 616 ) ages 40 - 70 were r and omly assigned to either a nutrition intervention or a control intervention unrelated to diet . Intervention included two 45-min counseling sessions plus two brief follow-up telephone contacts . Counseling sessions included a 20-min , interactive , computer-based intervention using a touch-screen format . Intervention goals were reducing dietary fat and increasing fruit and vegetable consumption . Outcome measures included a food frequency question naire and the Fat and Fiber Behavior Question naire ( FFBQ ) . Total serum cholesterol was also measured at baseline and 12 months . RESULTS Twelve-month follow-up data showed improvements on all dietary outcome variables . Compared to the control , intervention participants reported significantly less fat consumption ( 3.75 points less for percentage of energy from fat ) , significantly greater consumption of fruit and vegetables combined ( 0.93 more servings per day ) , and a significant reduction in a behavioral measure of fat consumption ( 0.20 point change in the FFBQ ) . Group differences in total serum cholesterol , while in the desired direction , were not significant . CONCLUSIONS In appropriate circumstances , moderate-intensity dietary interventions can show significant effects for periods of at least 1 year",
"Background : Research on the translation of efficacious lifestyle change programs to prevent type 2 diabetes into community or clinical setting s is needed . Objective : The objective of this study was to examine the reach , implementation , and efficacy of a 6-month lifestyle program implemented in primary care by nurse practitioners ( NPs ) for adults at risk of type 2 diabetes . Methods : The NP sites ( n = 4 ) were r and omized to an enhanced st and ard care program ( one NP and one nutrition session ) or a lifestyle program ( enhanced st and ard care and six NP sessions ) . These NPs recruited adults at risk of diabetes from their practice ( n = 58 ) , with an acceptance rate of 70 % . Results : The program reached a diverse , obese , and moderately low income sample . The NPs were able to successfully implement the protocol s. The average length of the program was 9.3 months . Attendance was high ( 98 % ) , and attrition was low ( 12 % ) . The NPs were able to adopt the educational , behavioral , and psychosocial strategies of the intervention easily . Motivational interviewing was more difficult for NPs . Mixed-model repeated- measures analysis indicated significant trends or improvement in both groups for nutrition and exercise behavior . Participants of the lifestyle program demonstrated trends for better high-density lipoprotein ( HDL ) and exercise behavior compared with the enhanced st and ard care participants . Twenty-five percent of lifestyle participants met treatment goals of 5 % weight loss compared with 11 % of st and ard care participants . Discussion : A lifestyle program can be implemented in primary care by NPs , reach the targeted population , and be modestly successful . Further research is indicated",
"BACKGROUND In the 2.8 years of the Diabetes Prevention Program ( DPP ) r and omised clinical trial , diabetes incidence in high-risk adults was reduced by 58 % with intensive lifestyle intervention and by 31 % with metformin , compared with placebo . We investigated the persistence of these effects in the long term . METHODS All active DPP participants were eligible for continued follow-up . 2766 of 3150 ( 88 % ) enrolled for a median additional follow-up of 5.7 years ( IQR 5.5 - 5.8 ) . 910 participants were from the lifestyle , 924 from the metformin , and 932 were from the original placebo groups . On the basis of the benefits from the intensive lifestyle intervention in the DPP , all three groups were offered group-implemented lifestyle intervention . Metformin treatment was continued in the original metformin group ( 850 mg twice daily as tolerated ) , with participants unmasked to assignment , and the original lifestyle intervention group was offered additional lifestyle support . The primary outcome was development of diabetes according to American Diabetes Association criteria . Analysis was by intention-to-treat . This study is registered with Clinical Trials.gov , number NCT00038727 . FINDINGS During the 10.0-year ( IQR 9.0 - 10.5 ) follow-up since r and omisation to DPP , the original lifestyle group lost , then partly regained weight . The modest weight loss with metformin was maintained . Diabetes incidence rates during the DPP were 4.8 cases per 100 person-years ( 95 % CI 4.1 - 5.7 ) in the intensive lifestyle intervention group , 7.8 ( 6.8 - 8.8 ) in the metformin group , and 11.0 ( 9.8 - 12.3 ) in the placebo group . Diabetes incidence rates in this follow-up study were similar between treatment groups : 5.9 per 100 person-years ( 5.1 - 6.8 ) for lifestyle , 4.9 ( 4.2 - 5.7 ) for metformin , and 5.6 ( 4.8 - 6.5 ) for placebo . Diabetes incidence in the 10 years since DPP r and omisation was reduced by 34 % ( 24 - 42 ) in the lifestyle group and 18 % ( 7 - 28 ) in the metformin group compared with placebo . INTERPRETATION During follow-up after DPP , incidences in the former placebo and metformin groups fell to equal those in the former lifestyle group , but the cumulative incidence of diabetes remained lowest in the lifestyle group . Prevention or delay of diabetes with lifestyle intervention or metformin can persist for at least 10 years . FUNDING National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK )",
"OBJECTIVE —The purpose of this study was to assess the effectiveness of a low – re source -intensive lifestyle modification program incorporating resistance training and to compare a gymnasium-based with a home-based resistance training program on diabetes diagnosis status and risk . RESEARCH DESIGN AND METHODS —A quasi-experimental two-group study was undertaken with 122 participants with diabetes risk factors ; 36.9 % had impaired glucose tolerance ( IGT ) or impaired fasting glucose ( IFG ) at baseline . The intervention included a 6-week group self-management education program , a gymnasium-based or home-based 12-week resistance training program , and a 34-week maintenance program . Fasting plasma glucose ( FPG ) and 2-h plasma glucose , blood lipids , blood pressure , body composition , physical activity , and diet were assessed at baseline and week 52 . RESULTS —Mean 2-h plasma glucose and FPG fell by 0.34 mmol/l ( 95 % CI −0.60 to −0.08 ) and 0.15 mmol/l ( −0.23 to −0.07 ) , respectively . The proportion of participants with IFG or IGT decreased from 36.9 to 23.0 % ( P = 0.006 ) . Mean weight loss was 4.07 kg ( −4.99 to −3.15 ) . The only significant difference between resistance training groups was a greater reduction in systolic blood pressure for the gymnasium-based group ( P = 0.008 ) . CONCLUSIONS —This intervention significantly improved diabetes diagnostic status and reduced diabetes risk to a degree comparable to that of other low – re source -intensive lifestyle modification programs and more intensive interventions applied to individuals with IGT . The effects of home-based and gymnasium-based resistance training did not differ significantly",
"Background Increasing prevalence of obesity and disorders associated with sedentary living constitute a major global public health problem . While previous evaluations of interventions to increase physical activity have involved communities or individuals with established disease , less attention has been given to interventions for individuals at risk of disease . Methods / design ProActive aims to evaluate the efficacy of a theoretical , evidence - and family-based intervention programme to increase physical activity in a sedentary population , defined as being at-risk through having a parental family history of diabetes . Primary care diabetes or family history registers were used to recruit 365 individuals aged 30–50 years , screened for activity level . Participants were assigned by central r and omisation to three intervention programmes : brief written advice ( comparison group ) , or a psychologically based behavioural change programme , delivered either by telephone ( distance group ) or face-to-face in the family home over one year . The protocol -driven intervention programme is delivered by trained facilitators , and aims to support increases in physical activity through the introduction and facilitation of a range of self-regulatory skills ( e.g. goal setting ) . The primary outcome is daytime energy expenditure and its ratio to resting energy expenditure , measured at baseline and one year using individually calibrated heart rate monitoring . Secondary measures include self-report of individual and family activity , psychological mediators of behaviour change , physiological and biochemical correlates , acceptability , and costs , measured at baseline , six months and one year . The primary intention to treat analysis will compare groups at one-year post r and omisation . Estimation of the impact on diabetes incidence will be modelled using data from a parallel ten-year cohort study using similar measures . Discussion ProActiveis the first efficacy trial of an intervention programme to promote physical activity in a defined high-risk group accessible through primary care . The intervention programme is based on psychological theory and evidence ; it introduces and facilitates the use of self-regulatory skills to support behaviour change and maintenance . The trial addresses a range of method ological weaknesses in the field by careful specification and quality assurance of the intervention programme , precise characterisation of participants , year-long follow-up and objective measurement of physical activity . Due to report in 2005 , ProActivewill provide estimates of the extent to which this approach could assist at-risk groups who could benefit from changes in behaviours affecting health , and inform future pragmatic trials",
"OBJECTIVE To determine whether reducing dietary fat would reduce body weight and improve long-term glycemia in people with glucose intolerance . RESEARCH DESIGN AND METHODS A 5-year Follow-up of a 1-year r and omized controlled trial of a reduced-fat ad libitum diet versus a usual diet . Participants with glucose intolerance ( 2-h blood glucose 7.0 - 11.0 mmol/l ) were recruited from a Workforce Diabetes Survey . The group that was r and omized to a reduced-fat diet participated in monthly small-group education sessions on reduced-fat eating for 1 year . Body weight and glucose tolerance were measured in 136 participants at baseline 6 months , and 1 year ( end of intervention ) , with follow-up at 2 years ( n = l04 ) , 3 years ( n = 99 ) , and 5 years ( n = 103 ) . RESULTS Compared with the control group , weight decreased in the reduced-fat-diet group ( P Glucose tolerance also improved in patients on the reduced-fat diet ; a lower proportion had type 2 diabetes or impaired glucose tolerance at 1 year ( 47 vs. 67 % , P fasting and 2-h glucose at 5 years ( P = 0.041 and P = 0.026 respectively ) compared with control subjects . CONCLUSIONS The natural history for people at high risk of developing type 2 diabetes is weight gain and deterioration in glucose tolerance . This process may be ameliorated through adherence to a reduced fat",
"OBJECTIVE —The objective of this study was to determine if a community-based modified Diabetes Prevention Program Group Lifestyle Balance ( GLB ) intervention , for individuals with metabolic syndrome , was effective in decreasing risk for type 2 diabetes and cardiovascular disease ( CVD ) in an urban medically underserved community , and subsequently to determine if improvements in clinical outcomes could be sustained in the short term . RESEARCH DESIGN AND METHODS —This nonr and omized prospect i ve intervention study used a one-group design to test the effectiveness of a community-based GLB intervention . Residents from 11 targeted neighborhoods were screened for metabolic syndrome ( n = 573 ) and took part in a 12-week GLB intervention ( n = 88 ) that addressed safe weight loss and physical activity . RESULTS —A marked decline in weight ( 46.4 % lost ≥5 % and 26.1 % lost ≥7 % ) was observed in individuals after completion of the intervention . Of these subjects , 87.5 % ( n = 28 ) and 66.7 % ( n = 12 ) sustained the 5 % and 7 % reduction , respectively , at the 6-month re assessment . Over one-third of the population ( 43.5 % , n = 30 ) experienced improvements in one or more component of metabolic syndrome , and 73.3 % ( n = 22 ) sustained this improvement at the 6-month re assessment . Additional improvements occurred in waist circumference ( P ) and blood pressure levels ( P = 0.04 ) after adjustment for age , sex , race , mean number of GLB classes attended , and time . CONCLUSIONS —Adults in an urban medically underserved community can decrease their risk for type 2 diabetes and CVD through participation in a GLB intervention , and short-term sustainability is feasible . Future research will include long-term follow-up of these subjects",
"Aims /hypothesisLifestyle modification helps in the primary prevention of diabetes in multiethnic American , Finnish and Chinese population s. In a prospect i ve community-based study , we tested whether the progression to diabetes could be influenced by interventions in native Asian Indians with IGT who were younger , leaner and more insulin resistant than the above population s. Methods We r and omised 531 ( 421 men 110 women ) subjects with IGT ( mean age 45.9±5.7 years , BMI 25.8±3.5 kg/m2 ) into four groups . Group 1 was the control , Group 2 was given advice on lifestyle modification ( LSM ) , Group 3 was treated with metformin ( MET ) and Group 4 was given LSM plus MET . The primary outcome measure was type 2 diabetes as diagnosed using World Health Organization criteria . Results The median follow-up period was 30 months , and the 3-year cumulative incidences of diabetes were 55.0 % , 39.3 % , 40.5 % and 39.5 % in Groups 1–4 , respectively . The relative risk reduction was 28.5 % with LSM ( 95 % CI 20.5–37.3 , p=0.018 ) , 26.4 % with MET ( 95 % CI 19.1–35.1 , p=0.029 ) and 28.2 % with LSM + MET ( 95 % CI 20.3–37.0 , p=0.022 ) , as compared with the control group . The number needed to treat to prevent one incident case of diabetes was 6.4 for LSM , 6.9 for MET and 6.5 for LSM + MET . Conclusions /interpretationProgression of IGT to diabetes is high in native Asian Indians . Both LSM and MET significantly reduced the incidence of diabetes in Asian Indians with IGT ; there was no added benefit from combining them",
"OBJECTIVE It is well established that the risk of developing type 2 diabetes is closely linked to the presence and duration of overweight and obesity . A reduction in the incidence of type 2 diabetes with lifestyle changes has previously been demonstrated . We hypothesized that adding a weight-reducing agent to lifestyle changes may lead to an even greater decrease in body weight , and thus the incidence of type 2 diabetes , in obese patients . RESEARCH DESIGN AND METHODS In a 4-year , double-blind , prospect i ve study , we r and omized 3,305 patients to lifestyle changes plus either orlistat 120 mg or placebo , three times daily . Participants had a BMI > /=30 kg/m2 and normal ( 79 % ) or impaired ( 21 % ) glucose tolerance ( IGT ) . Primary endpoints were time to onset of type 2 diabetes and change in body weight . Analyses were by intention to treat . RESULTS Of orlistat-treated patients , 52 % completed treatment compared with 34 % of placebo recipients ( P cumulative incidence of diabetes was 9.0 % with placebo and 6.2 % with orlistat , corresponding to a risk reduction of 37.3 % ( P = 0.0032 ) . Exploratory analyses indicated that the preventive effect was explained by the difference in subjects with IGT . Mean weight loss after 4 years was significantly greater with orlistat ( 5.8 vs. 3.0 kg with placebo ; P orlistat recipients with impaired ( 5.7 kg ) or normal glucose tolerance ( NGT ) ( 5.8 kg ) at baseline . A second analysis in which the baseline weights of subjects who dropped out of the study was carried forward also demonstrated greater weight loss in the orlistat group ( 3.6 vs. 1.4 kg ; P orlistat plus lifestyle changes result ed in a greater reduction in the incidence of type 2 diabetes over 4 years and produced greater weight loss in a clinical ly representative obese population . Difference in diabetes incidence was detectable only in the IGT subgroup ; weight loss was similar in subjects with IGT or NGT [ correction ]",
"BACKGROUND This study assessed the clinical impact of lifestyle change education on chronic disease risk factors within a community . DESIGN R and omized clinical trial . SETTING / PARTICIPANTS Participants included 337 volunteers age 43 to 81 years from the Rockford , IL , metropolitan area . INTERVENTION The intervention group attended a 40-hour educational course delivered over a 4-week period . Participants learned the importance of making healthful lifestyle choices and how to make improvements in nutrition and physical activity . MAIN OUTCOME MEASURES Changes in health knowledge , nutrition , and physical activity behavior , and several chronic disease risk factors were assessed at baseline and 6 weeks . RESULTS Beneficial mean changes in scores tended to be significant for the intervention group but not for the control group . Variables with improved scores included health knowledge , percent body fat , total steps per week , and most nutrition variables . Clinical improvements were seen in resting heart rate , total cholesterol , low-density lipoprotein cholesterol , and systolic and diastolic blood pressure . The control group experienced comparatively small but significant improvements in health knowledge , systolic and diastolic blood pressure , glucose , and in some nutrition variables . For almost all variables , the intervention group showed significantly greater improvements . CONCLUSIONS This lifestyle modification program is an efficacious nutrition and physical activity intervention in the short term and has the potential to dramatically reduce the risks associated with common chronic diseases in the long term",
"BACKGROUND Lifestyle interventions can prevent the deterioration of impaired glucose tolerance to manifest type 2 diabetes , at least as long as the intervention continues . In the extended follow-up of the Finnish Diabetes Prevention Study , we assessed the extent to which the originally-achieved lifestyle changes and risk reduction remain after discontinuation of active counselling . METHODS Overweight , middle-aged men ( n=172 ) and women ( n=350 ) with impaired glucose tolerance were r and omly assigned to intensive lifestyle intervention or control group . After a median of 4 years of active intervention period , participants who were still free of diabetes were further followed up for a median of 3 years , with median total follow-up of 7 years . Diabetes incidence , bodyweight , physical activity , and dietary intakes of fat , saturated fat , and fibre were measured . FINDINGS During the total follow-up , the incidence of type 2 diabetes was 4.3 and 7.4 per 100 person-years in the intervention and control group , respectively ( log-rank test p=0.0001 ) , indicating 43 % reduction in relative risk . The risk reduction was related to the success in achieving the intervention goals of weight loss , reduced intake of total and saturated fat and increased intake of dietary fibre , and increased physical activity . Beneficial lifestyle changes achieved by participants in the intervention group were maintained after the discontinuation of the intervention , and the corresponding incidence rates during the post-intervention follow-up were 4.6 and 7.2 ( p=0.0401 ) , indicating 36 % reduction in relative risk . INTERPRETATION Lifestyle intervention in people at high risk for type 2 diabetes result ed in sustained lifestyle changes and a reduction in diabetes incidence , which remained after the individual lifestyle counselling was stopped",
"Summary From a previously reported 5-year screening programme of 6,956 47–49-year-old Malmö males , a series of 41 subjects with early-stage Type 2 ( non-insulin-dependent ) diabetes mellitus and 181 subjects with impaired glucose tolerance were selected for prospect i ve study and to test the feasibility aspect of long-term intervention with an emphasis on life-style changes . A 5-year protocol , including an initial 6-months ( r and omised ) pilot study , consisting of dietary treatment and /or increase of physical activity or training with annual check-ups , was completed by 90 % of subjects . Body weight was reduced by 2.3–3.7 % among participants , whereas values increased by 0.5–1.7 % in non-intervened subjects with impaired glucose tolerance and in normal control subjects ( p oxygen uptake ( ml · min−1 · kg−1 ) was increased by 10–14 % vs decreased by 5–9 % , respectively ( p was normalized in > 50 % of subjects with impaired glucose tolerance , the accumulated incidence of diabetes was 10.6 % , and more than 50 % of the diabetic patients were in remission after a mean follow-up of 6 years . Blood pressure , lipids , and hyperinsulinaemia were reduced and early insulin responsiveness to glucose loading preserved . Improvement in glucose tolerance was correlated to weight reduction ( r=0.19 , p ) and increased fitness ( r=0.22 , p ) . Treatment was safe , and mortality was low ( in fact 33 % lower than in the remainder of the cohort ) . We conclude that long-term intervention in the form of diet and physical exercise is feasible even on a large scale , and that substantial metabolic improvement can be achieved which may contribute to prevent or postpone manifest diabetes",
"OBJECTIVE To assess the effect of lifestyle intervention over 2 years on changes in weight , coronary heart disease ( CHD ) risk factors , and incidence of diabetes in overweight individuals with a parental history of diabetes . RESEARCH DESIGN AND METHODS Participants ( n = 154 ) , who were 30–100 % over ideal body weight , had one or both parents with diabetes , and were currently nondiabetic , were r and omly assigned to 2-year treatments focused on diet ( decreasing calories and fat intake ) , exercise ( goal of 1,500 kcal/week of moderate activity ) , or the combination of diet plus exercise or to a no-treatment control group . Subjects were reassessed at 6 months , 1 year , and 2 years . RESULTS At 6 months , the groups differed significantly on measures of eating , exercise , and fitness ; weight losses in the diet and diet-plus-exercise groups were significantly > in the exercise and control conditions . Weight losses were associated with positive changes in CHD risk factors . After 6 months , there was gradual deterioration of behavioral and physiological changes , so that at 2 years , almost no between-group differences were maintained . Differences between groups in risk of developing diabetes were of borderline significance ( P = 0.08 ) . Strongest predictors were impaired glucose tolerance at baseline , which was positively related to risk of developing diabetes , and weight loss from baseline to 2 years , which was negatively related ; in all treatment groups , a modest weight loss of 4.5 kg reduced the risk of type 2 diabetes by ∼ 30 % compared with no weight loss . CONCLUSIONS Although initially successful , the interventions studied here were not effective in producing long-term changes in behavior , weight , or physiological parameters . However , weight loss from 0 to 2 years reduced the risk of developing type 2 diabetes . Since modest weight loss significantly reduced risk of type 2 diabetes , further research is needed to determine how best to increase the percentage of subjects achieving at least a modest weight loss ",
"OBJECTIVE To determine whether diet and endurance exercise improved adiposity-related measurements in Japanese Americans with impaired glucose tolerance ( IGT ) . RESEARCH DESIGN AND METHODS This study compared the effects of an American Heart Association ( AHA ) step 2 diet ( on BMI , body composition ( % fat ) , and body fat distribution at 6 and 24 months of follow-up in 64 Japanese American men and women with IGT , 58 of whom completed the study . RESULTS At 6 months , the treatment group showed significantly greater reduction in percent , body fat ( -1.4 + /- 0.4 vs. -0.3 + /- 0.3 % ) ; BMI ( -1.1 + /- 0.2 vs. -0.4 + /- 0.1 kg/m(2 ) ) ; subcutaneous fat by computed tomography at the abdomen ( -29.3 + /- 4.2 vs. -5.7 + /- 5.9 cm(2 ) ) , thigh ( -13.2 + /- 3.6 vs. -3.6 + /- 3.0 cm(2 ) ) , and thorax ( -19.6 + /- 3.6 vs. -8.9 + /- 2.6 cm(2 ) ) ; and skinfold thickness at the bicep ( -2.0 + /- 0.6 vs. 1.1 + /- 0.6 mm ) and tricep ( -3.7 + /- 0.8 vs. -0.9 + /- 0.6 mm ) , which continued despite moving to home-based exercise for the last 18 months . CONCLUSIONS Diet and endurance exercise improved BMI , body composition , and body fat distribution and , thus , may delay or prevent type 2 diabetes in Japanese Americans with IGT",
"We have assessed the impact of a 2-year pilot church-base diabetes risk reduction programme on major lifestyle predictors of future Type 2 diabetes mellitus : exercise and weight control in a prospect i ve non-r and omized controlled study of a modular lifestyle and diabetes awareness intervention programme using a community development model . The study involved two complete church congregations from an ethnic group at high risk of diabetes ( Western Samoans ) ( intervention church n = 78 ; control church n = 144 ) . Weight remained stable ( 0+/-4.8 kg ) in the intervention church but increased by 3.1+/-9.8 kg in the control church ( p = 0.05 ) . In the intervention church , there was an associated reduction in waist circumference ( -4+/-10 cm vs + 2+/-7 cm in control , p diabetes knowledge ( 46+/-26 % vs 4+/-17 % in control , p increase in the proportion exercising regularly ( + 22 % vs -8 % in control , p Consumption of key fatty foods was also reduced in the intervention church . We conclude that diabetes risk reduction programmes based upon lifestyle change , diabetes awareness , and empowerment of high risk communities can significantly reduce risk factors for future Type 2 diabetes",
"Thirty-one subjects with impaired glucose tolerance were r and omly allocated to a group receiving advice to improve their diet and physical activity levels over 6 months ( n = 23 ) or to a control group ( n = 8) . At 6 months , 18 of the 23 subjects receiving ' healthy living ' advice were re-examined ( five subjects had withdrawn ) . Fourteen of the 18 subjects showed an alteration in diet or an increase in exercise . The 18 subjects re-evaluated showed a reduction in systolic blood pressure ( 118 + /- 15 vs 124 + /- 15 mmHg , p less than 0.05 ) and decrease in total plasma cholesterol ( 4.5 + /- 1 vs 5.2 + /- 1 mmol l-1 , p less than 0.01 ) and LDL-cholesterol levels ( 2.8 + /- 0.9 vs 3.2 + /- 0.9 mmol l-1 , p less than 0.05 ) . Plasma glucose levels were unchanged . One subject withdrew from the control group . At 6 months , the seven control subjects examined showed no significant change in metabolic parameters , with little measurable change in diet or exercise . At 2 years , 17 of the 23 ' healthy living ' subjects were reassessed . Nine of the subjects had continued to exercise or maintained a decreased weight compared to baseline . Fasting plasma glucose levels had increased ( 6.0 + /- 1.2 vs 5.5 + /- 0.6 mmol l-1 , p less than 0.05 ) , with the only continued improvement being a reduced LDL level ( 2.8 + /- 0.7 vs 3.1 + /- 0.9 mmol l-1 , p less than 0.05 ) . At 2 years , a similar proportion of the control group were taking regular exercise compared with the ' healthy living ' group . ( ABSTRACT TRUNCATED AT 250 WORDS",
"AIMS : Important risk factors for the progression from impaired glucose tolerance to type II diabetes mellitus are obesity , diet and physical inactivity . The aim of this study is to evaluate the effect of a lifestyle-intervention programme on glucose tolerance in Dutch subjects with impaired glucose tolerance ( IGT ) . METHODS : A total of 102 subjects were studied , r and omised into two groups . Subjects in the intervention group received regular dietary advice , and were stimulated to lose weight and to increase their physical activity . The control group received only brief information about the beneficial effects of a healthy diet and increased physical activity . Before and after the first year , glucose tolerance was measured and several other measurements were done . RESULTS : Body weight loss after 1 y was higher in the intervention group . The 2-h blood glucose concentration decreased 0.8±0.3 mmol/l in the intervention group and increased 0.2±0.3 mmol/l in the control group ( P . Body weight loss and increased physical fitness were the most important determinants of improved glucose tolerance and insulin sensitivity . CONCLUSION : A lifestyle-intervention programme according to general recommendations is effective and induces beneficial changes in lifestyle , which improve glucose tolerance in subjects with IGT . Body weight loss and increased physical fitness were the most important determinants of improved glucose tolerance and insulin sensitivity ",
"OBJECTIVE Individuals with impaired glucose tolerance ( IGT ) have a high risk of developing NIDDM . The purpose of this study was to determine whether diet and exercise interventions in those with IGT may delay the development of NIDDM , i.e. , reduce the incidence of NIDDM , and thereby reduce the overall incidence of diabetic complications , such as cardiovascular , renal , and retinal disease , and the excess mortality attributable to these complications . RESEARCH DESIGN AND METHODS In 1986 , 110,660 men and women from 33 health care clinics in the city of Da Qing , China , were screened for IGT and NIDDM . Of these individuals , 577 were classified ( using World Health Organization criteria ) as having IGT . Subjects were r and omized by clinic into a clinical trial , either to a control group or to one of three active treatment groups : diet only , exercise only , or diet plus exercise . Follow-up evaluation examinations were conducted at 2-year intervals over a 6-year period to identify subjects who developed NIDDM . Cox 's proportional hazard analysis was used to determine if the incidence of NIDDM varied by treatment assignment . RESULTS The cumulative incidence of diabetes at 6 years was 67.7 % ( 95 % CI , 59.8–75.2 ) in the control group compared with 43.8 % ( 95 % CI , 35.5–52.3 ) in the diet group , 41.1 % ( 95 % CI , 33.4–49.4 ) in the exercise group , and 46.0 % ( 95 % CI , 37.3–54.7 ) in the diet-plus-exercise group ( P relative decrease in rate of development of diabetes in the active treatment groups was similar when subjects were stratified as lean or overweight ( BMI baseline BMI and fasting glucose , the diet , exercise , and diet-plus-exercise interventions were associated with 31 % ( P risk of developing diabetes , respectively . CONCLUSIONS Diet and /or exercise interventions led to a significant decrease in the incidence of diabetes over a 6-year period among those with IGT",
"Objective : Following unblinding of the Diabetes Prevention Program ( DPP ) results , a 16-session lifestyle intervention program was offered to all study participants , including those who had initially been r and omized to lifestyle treatment . This study compares the effects of the lifestyle program between participants who had previous exposure and those who had not . Design : A 16-session behavioral intervention was conducted in groups at each of the 27 DPP sites during a transitional ( bridge ) period from the DPP trial to the DPP Outcomes Study ( DPPOS ) . Session participation for this 6-month behavioral weight loss program was confirmed by originally r and omized treatment groups . Subjects and measurements : Independently assessed weight measurements were available within a 7-month period before and after the program for 2808 ethnically diverse participants . Results : Participants from the lifestyle group in the DPP were the least likely to attend a repeat offering of a 16-session behavioral weight loss program conducted in groups . Weight loss during the transitional lifestyle program was strongly related to the duration of attendance in the three groups that were participating in the program for the first time ( metformin , placebo and troglitazone ) , but not related to amount of earlier weight loss . Conclusion : Individuals who were naive to the behavioral program lost a greater amount of weight and this was strongly related to their degree of participation . A second exposure to a behavioral weight loss program result ed in unsatisfactory low attendance rates and weight loss",
"Self-referred subjects ( N = 227 ) thought to be at risk of developing non-insulin-dependent diabetes mellitus ( NIDDM ) and with fasting plasma glucose ( FPG ) in the range of 5.5 to 7.7 mmol . L-1 on two consecutive tests 2 weeks apart were r and omized to reinforced or basic healthy-living advice . They were simultaneously allocated either to a sulfonylurea group or a control group in a two-by-two factorial design . A total of 201 subjects in three English and two French centers completed 1 year 's follow-up study . Reinforced advice recommending dietary modification and increased exercise was given every 3 months , and basic advice was given once at the initial visit . Glycemia was monitored by FPG , dietary compliance by body weight and food diaries , and fitness compliance by bicycle ergometer assessment and exercise diaries . Both reinforced and basic advice groups had a significant mean reduction in body weight ( 1.5 kg ) at 3 months , although the weight subsequently returned to baseline . After 1 year , subjects allocated to reinforced advice versus basic advice ( 1 ) reported a lower fat intake ( 34.1 % v 35.8 % , P = .04 ) with no difference in lipid profiles , ( 2 ) had improved fitness as shown by increased calculated maximal oxygen uptake ( [ Vo2max ] 2.39 v 2.18 L.min-1 , P = .007 ) with no change in insulin sensitivity , ( 3 ) showed no change in FPG , glucose tolerance , or hemoglobin A1c ( HbA1c ) , and ( 4 ) showed a greater tendency to withdraw from the study ( 16 % v 7 % , P = .03 ) . In conclusion , reinforced healthy-living advice given to self-referred subjects with increased FPG did not encourage sufficiently pronounced life-style changes for significantly greater effects on body weight and glycemia in a 1-year study than basic healthy-living advice",
"BACKGROUND Type 2 diabetes affects approximately 8 percent of adults in the United States . Some risk factors -- elevated plasma glucose concentrations in the fasting state and after an oral glucose load , overweight , and a sedentary lifestyle -- are potentially reversible . We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes . METHODS We r and omly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo , metformin ( 850 mg twice daily ) , or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week . The mean age of the participants was 51 years , and the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 34.0 ; 68 percent were women , and 45 percent were members of minority groups . RESULTS The average follow-up was 2.8 years . The incidence of diabetes was 11.0 , 7.8 , and 4.8 cases per 100 person-years in the placebo , metformin , and lifestyle groups , respectively . The lifestyle intervention reduced the incidence by 58 percent ( 95 percent confidence interval , 48 to 66 percent ) and metformin by 31 percent ( 95 percent confidence interval , 17 to 43 percent ) , as compared with placebo ; the lifestyle intervention was significantly more effective than metformin . To prevent one case of diabetes during a period of three years , 6.9 persons would have to participate in the lifestyle-intervention program , and 13.9 would have to receive metformin . CONCLUSIONS Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk . The lifestyle intervention was more effective than metformin",
"OBJECTIVES The purpose of this study was to determine the feasibility of implementing a diabetes prevention program ( DPP ) in a rural African-American church . METHODS A six-session DPP , modeled after the successful National Institutes of Health ( NIH ) DPP , was implemented in a rural African-American church . Adult members of the church identified as high risk for diabetes , based on results of a risk question naire , were screened with a fasting glucose . Persons with prediabetes , a fasting glucose of 100 - 125 mg/dL , participated in the six-session , Lifestyle Balance Church DPP . The primary outcomes were attendance rates and changes in fasting glucose , weight and body mass index measured at baseline , six- and 12-month follow-up . RESULTS Ninety-nine adult church members were screened for diabetes risk . Eleven had impaired fasting glucose . Ten of 11 participated in the six-session intervention , for an attendance rate of 78 % . After the intervention and 12-month follow-up , there was a mean weight loss of 7.9 lbs and 10.6 lbs , respectively . CONCLUSIONS This pilot project suggests that a modified six-session DPP can be translated to a group format and successfully implemented in a church setting . Further r and omized studies are needed to determine the effectiveness of such an intervention",
"BACKGROUND Weight-loss medications are recommended as an adjunct to a comprehensive program of diet , exercise , and behavior therapy but are typically prescribed with minimal or no lifestyle modification . This practice is likely to limit therapeutic benefits . METHODS In this one-year trial , we r and omly assigned 224 obese adults to receive 15 mg of sibutramine per day alone , delivered by a primary care provider in eight visits of 10 to 15 minutes each ; lifestyle-modification counseling alone , delivered in 30 group sessions ; sibutramine plus 30 group sessions of lifestyle-modification counseling ( i.e. , combined therapy ) ; or sibutramine plus brief lifestyle-modification counseling delivered by a primary care provider in eight visits of 10 to 15 minutes each . All subjects were prescribed a diet of 1200 to 1500 kcal per day and the same exercise regimen . RESULTS At one year , subjects who received combined therapy lost a mean ( + /-SD ) of 12.1+/-9.8 kg , whereas those receiving sibutramine alone lost 5.0+/-7.4 kg , those treated by lifestyle modification alone lost 6.7+/-7.9 kg , and those receiving sibutramine plus brief therapy lost 7.5+/-8.0 kg ( P combined-therapy group who frequently recorded their food intake lost more weight than those who did so infrequently ( 18.1+/-9.8 kg vs. 7.7+/-7.5 kg , P=0.04 ) . CONCLUSIONS The combination of medication and group lifestyle modification result ed in more weight loss than either medication or lifestyle modification alone . The results underscore the importance of prescribing weight-loss medications in combination with , rather than in lieu of , lifestyle modification",
"Introduction Chronic diseases such as cancer , cardiovascular disease , stroke , and diabetes are responsible for most deaths in the United States . Lifestyle factors — poor nutrition , sedentary living , and tobacco use — appear to play a prominent role in the development of many chronic diseases . This study determined the behavioral and clinical impact of a therapeutic lifestyle-modification intervention on a group of community volunteers . Methods Participants included 348 volunteers aged 24 to 81 years from the Rockford , Ill , metropolitan area who participated in a r and omized clinical trial . The intervention group attended a 40-hour educational course delivered as lectures during a 4-week period . Participants learned the importance of making better lifestyle choices and how to make improvements in nutrition and physical activity . Changes in nutrition , physical activity behavior , and several chronic disease risk factors were assessed at baseline and 6 months . Results Intervention participants showed significant 6-month improvement in all nutrition and physical activity measures except calories from protein and whole-grain servings and all clinical measures except blood glucose , total cholesterol , triglycerides , and high-sensitivity C-reactive protein . Total cholesterol and low-density lipoprotein cholesterol were worse after 6 months in both groups but only significantly worse in the control group . The control group experienced small but significant improvements in systolic and diastolic blood pressure and high-density lipoproteins . Change-score comparisons between the intervention and control groups were significant for all nutrition and physical activity variables except total steps per week and daily sodium intake and were also significant for the clinical measures of weight , body fat , and body mass index . Conclusion This therapeutic lifestyle-modification program can significantly improve nutrition and physical activity behavior and can reduce many of the risk factors associated with common chronic diseases",
"OBJECTIVES We evaluated the effectiveness of a minimal intervention physical activity strategy ( physician-based assessment and counseling for exercise [ PACE ] ) applied in general practice setting s in the Netherl and s. METHODS R and omization took place at the general practice level . Participants were patients aged 18 - 70 years of age who had been diagnosed with hypertension , hypercholesterolemia , or non-insulin-dependent diabetes and had not been regularly physically active in the past 6 months . Outcome measures were assessed at baseline and at 8-week , 6-month , and 1-year follow-ups . RESULTS No significant intervention effect over time was observed on physical activity level or stage of change for regular physical activity , and an inverse intervention effect was observed for waist circumference . However , the study population as a whole exhibited a significant increase in physical activity and a borderline significant decrease in body weight at the 1-year follow-up . CONCLUSIONS Positive effects on physical activity level and body weight were observed , but the PACE intervention was not more effective than the st and ard physical activity advice",
"BACKGROUND Around 10 - 15 % of adults aged over 40 years have pre-diabetes , which carries a high risk of progression to type 2 diabetes . Intensive lifestyle intervention reduces progression by as much as 58 % . However , the cost and personnel requirements of these interventions are major obstacles to delivery in NHS primary care . AIM To assess the effectiveness of a low-cost intervention , delivered in primary care by non-NHS staff , to reduce the risk of diabetes through weight loss and physical activity . DESIGN OF STUDY Pragmatic single-blind r and omised controlled trial with research ers and statistician blinded to group allocation . SETTING UK primary care . METHOD One-hundred and forty-one participants with a body mass index of 28 kg/m2 or more , but without diabetes or heart disease , received either information leaflets or individual behavioural counselling using motivational interviewing techniques . The intervention was delivered by five counsellors recruited from the local community . The primary outcomes were the proportions of participants meeting predefined targets for weight loss ( 5 % ) and moderate physical activity ( 150 minutes/week ) after 6 months . RESULTS Using intention-to-treat analysis , more people in the intervention group achieved the weight-loss target ( 24 % versus 7 % for controls ; odds ratio [OR]=3.96 ; 95 % confidence interval [Cl]=1.4 to 11.4 ; number needed to treat [NNT]=6.1 ( 95 % Cl=4 to 21 ) . The proportion achieving the physical activity target did not increase significantly ( 38 % versus 28 % for controls ; OR=1.6 ; 95 % Cl=0.7 to 3.8 ) . CONCLUSION Short-term weight loss , at a level which , if sustained , is clinical ly meaningful for reducing diabetes risk , is achievable in primary care , without excessive use of NHS monetary or personnel re sources",
"AIM To evaluate the effectiveness of lifestyle interventions in people with impaired glucose tolerance ( IGT ) . METHODS Participants with IGT ( n=78 ) , diagnosed on two consecutive oral glucose tolerance tests ( OGTTs ) , were r and omly assigned to a 2-year lifestyle intervention or to a control group . Main outcome measures were changes from baseline in : nutrient intake ; physical activity ; anthropometry , glucose tolerance and insulin sensitivity . Measurements were repeated at 6 , 12 and 24 months follow-up . RESULTS After 24 months follow-up , there was a significant fall in total fat consumption ( difference in change between groups ( Delta intervention-Delta control)= -17.9 , 95 % confidence interval ( CI ) -33.6 to -2.1g/day ) as a result of the intervention . Body mass was significantly lower in the intervention group compared with controls after 6 months ( -1.6 , 95 % CI -2.9 to -0.4 kg ) and 24 months ( -3.3 , 95 % CI -5.7 to -0.89 kg ) . Whole body insulin sensitivity , assessed by the short insulin tolerance test ( ITT ) , improved after 12 months in the intervention group ( 0.52 , 95 % CI 0.15 - 0.89%/min ) . CONCLUSIONS These findings complement the findings of the Finnish Diabetes Prevention Study and the American Diabetes Prevention Study , both of which tested intensive interventions , by showing that pragmatic lifestyle interventions result in improvements in obesity and whole body insulin sensitivity in individuals with IGT , without change in other cardiovascular risk factors"
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4117488a-06ff-11f0-808a-c43d1ab1c353
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Taking performance-enhancing drugs ( PEDs ) can cause serious and irreversible health consequences , which can ultimately lead to premature death . Some young people may take PEDs without fully underst and ing the ramifications of their actions or based on the advice from others . The purpose of this systematic review was to identify the main factors that predicted doping among young people . The literature was systematic ally review ed using search engines , manually search ing specialist journals , and pearl growing . Fifty-two studies , which included 187,288 young people aged between 10 and 21 years of age , 883 parents of adolescent athletes , and 11 adult coaches , who were interviewed regarding young athletes , were included in this review . Nine factors predicted doping among young people : gender ; age ; sports participation ; sport type ; psychological variables ; entourage ; ethnicity ; nutritional supplements ; and health harming behaviors . In regards to psychological variables , 22 different constructs were associated with doping among young people . Some psychological constructs were negatively associated with doping ( e.g. , self-esteem , resisting social pressure , and perfectionist strivings ) , whereas other were positively associated with doping ( e.g. , suicide risk , anticipated regret , and aggression ) . Policy makers and National Anti-Doping Organizations could use these findings to help identify athletes who are more at risk of doping and then expose these individuals to anti-doping education . Based on the current findings , it also appears that education programs should commence at the onset of adolescence or even late childhood , due to the young age in which some individuals start doping
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[
"Eight-hundred seventy-three Indiana high school football players were surveyed to investigate the use of anabolic- and rogenic steroids ( AAS ) . Subjects were varsity football players that were r and omly selected from 27 high schools throughout Indiana . Out of a possible 1,325 subjects , 873 or 66 % participated in the study . Subjects completed a 50 item question naire that measured demographic information , perceived use of AAS , reasons for use , and how AAS are taken . The results indicate that 6.3 % of Indiana high school football players were current or former AAS users . The average age at time of first use of AAS was 14 years and 15 % began taking before the age of ten . Almost half of respondents indicated they could obtain AAS if they so desired , and that other athletes , physicians , and coaches were listed as sources for AAS . Athletic trainers can play a vital role in disseminating accurate information about AAS abuse , including the long-term adverse health risks . These messages should begin with students and athletes as early as the fourth and fifth grade s and delivered as often as possible throughout the school years",
"OBJECTIVE To assess the prevalence of use of anabolic- and rogenic steroids and other presumed performance-enhancing drugs and the associated knowledge , attitudes , and behavior of school-aged Canadians . DESIGN A national survey was conducted using a self-report question naire distributed r and omly to schools within each of five Canadian regions . SETTING Canada . SUBJECTS The subjects were 16,119 Canadian students , in the sixth grade and above , from 107 schools drawn r and omly from five Canadian regions . MAIN OUTCOME MEASUREMENTS The number of students reporting the use of anabolic- and rogenic steroids and other performance-enhancing drugs in the year before the survey , the nature of such drug-taking activities , and the attitudes underlying the decision to take anabolic- and rogenic steroids . RESULTS More than 83,000 young Canadians ( 2.8 % of the respondents ) are estimated to have used anabolic- and rogenic steroids in the year before the survey . Of those taking such drugs , 29.4 % reported that they injected them ; of the latter group , 29.2 % reported sharing needles in the course of injecting anabolic- and rogenic steroids . Significant numbers of respondents reported using other substances ( caffeine , 27 % ; extra protein , 27 % ; alcohol , 8.6 % ; painkillers , 9 % ; stimulants , 3.1 % ; \" doping methods , \" 2.3 % ; beta-blockers , 1 % ) in attempts to improve sport performance . CONCLUSIONS The use of anabolic- and rogenic steroids is more widespread than may have been assumed and is often accompanied by high-risk needle-sharing . Anabolic- and rogenic steroid use is often intended to alter body build as opposed to accentuating sport performance . Many young Canadians use a variety of other substances in attempts to improve sport performance . Drug-taking of this kind represents a special challenge for educators , health professionals , and sport authorities",
"PURPOSE To prospect ively study the stability of anabolic and rogenic steroid ( AAS ) use and predictors of AAS use , and to investigate whether AAS use alters the risk of later emotional and behavioral problems . METHODS Survey of a national sample of Norwegian high school students ( age 15 - 19 ) in 1994 followed up in 1999 ( N = 2924 ) . Measures of frequent alcohol intoxication ( 50 + times per 12 months ) , cannabis use ( 12 months ) , hard drug use ( 12 months ) , being offered cannabis , eating problems , conduct problems , sexual debut before age 15 , BMI , involvement in power sports , perceived physical appearance , and satisfaction with body parts were obtained . RESULTS Life-time prevalence of AAS use were 1.9 and 0.8 % in the follow-up period . Multivariate logistic regression revealed that future AAS use was predicted by young age , male gender , previous AAS use , involvement in power sports , and frequent alcohol intoxication . AAS use did not predict future emotional or behavioral problems other than reducing the risk of future frequent alcohol intoxication . CONCLUSION Frequent alcohol intoxication and involvement in power sports appear to predict future AAS use . At the population level there was little stability in individual AAS use from adolescence to early adulthood . No detrimental effects of AAS use could be detected in this study , but low statistical power limits this conclusion",
"There is evidence to suggest that the prevalence of anabolic- and rogenic steroids ( AAS ) is higher among young people than the general population . The purpose of the current study was to examine the proportion of students who reported lifetime and past-year AAS use , explore other drug use among those who reported AAS use , and investigate demographic correlates of AAS use . Data was taken from a cross-sectional survey of a representative sample of Australian secondary students . A stratified two-stage probability sampling methodology was employed and schools were r and omly sample d from each Australian State and Territory . A total of 376 schools participated in the survey . Lifetime AAS use was reported by 2.4 % of 12 - 17-year-old students ; use was more common among 12 - 15-year olds then 16 - 17-year olds . Regardless of age , being male , speaking a language other than English at home , not be at school on the previous school day , and rating own scholastic ability as below average were all associated with a greater likelihood of using AAS in their lifetime and in the past year . Those who reported AAS use also reported the use of a range of other substances , suggesting that AAS use may be part of a broader experimentation with substances . Interventions towards these groups regarding AAS may best be placed within a larger substance use intervention rather than being AAS-specific . In light of the low levels of AAS use among this group , more detailed research into AAS use among adolescent sporting groups may be warranted",
"OBJECTIVE To develop and test a school-based intervention to prevent anabolic and rogenic steroid use among high-risk adolescent athletes . DESIGN Nonr and om controlled trial . SETTING Two urban high schools . PARTICIPANTS Fifty-six adolescent football players at the experimental school and 24 players at the control school . INTERVENTION Eight weekly , 1-hour classroom sessions delivered by the coach and adolescent team leaders , and eight weight-room sessions delivered by research staff . The intervention addressed sports nutrition and strength training as alternatives to steroid use , drug refusal role play , and antisteroid media campaigns . OUTCOME MEASURES A preintervention and postintervention question naire that assessed attitudes toward and intent to use steroids and other drugs ; knowledge of drug effects ; and diet , exercise , and related constructs . RESULTS Compared with controls , experimental subjects were significantly less interested in trying steroids after the intervention , were less likely to want to use them even if their friends used them , were less likely to believe steroid use was a good idea , believed steroids were more dangerous , had better knowledge of alternatives to steroid use , had improved body image , increased their knowledge of diet supplements , and had less belief in these supplements as beneficial . CONCLUSIONS Significant beneficial effects were found despite the sample size , suggesting that the effects of the intervention was large . This outcome trial demonstrates an effective anabolic and rogenic steroid prevention program for adolescent athletes , and the potential of team-based interventions to enhance adolescents ' health",
"Objective : To describe the prevalence of doping and its progression in a cohort of preadolescent athletes during a 4-year follow-up . Design and setting s : Prospect i ve cohort study . Self- question naire survey . Participants : All of the pupils entering the first year of secondary school ( sixth grade ) in the Vosges Département ( east France ) and followed for 4 years . Main outcome measurements : Drug use ( prohibited substances , tobacco , alcohol , cannabis ) , intention to use , reported health hazards , perceived drug effectiveness , self-esteem , trait anxiety . Results : At the beginning of the study , 1.2 % ( 95 % CI 0.8 to 1.6 ) stated that they had taken doping agents at least once in the preceding 6 months , and this had risen to 3.0 % ( 95 % CI 2.3–3.7 ) 4 years later ( p doping agents , 4 % reported that they had experienced a health problem related to doping , and 44 % reported that they had won at least one sports event as a result of using the drug . Use of doping agents is linked to the number of hours of practice per week , intention to use , use of other drugs , self-esteem and trait anxiety . Conclusions : The results show that doping does exist in preadolescent athletes who train every day . This fact should to be taken into account in preventive actions",
"OBJECTIVE This study examined the relationships between anabolic-steroid use and the use of other drugs , sports participation , strength training , and school performance among a nationally representative sample of US high school students . DESIGN R and omized survey data from the 1991 Centers for Disease Control and Prevention Youth Risk Behavior Survey . SETTING Public and private schools in the 50 United States and District of Columbia . PATIENTS A total of 12,272 9th through 12th grade students . MAIN OUTCOME MEASURED Prevalence of anabolic-steroid use . RESULTS The frequency of anabolic-steroid use was significantly associated with the frequency of use of cocaine , the use of other drugs such as amphetamines and heroin , tobacco smoking , and alcohol use . The weighted prevalences of anabolic-steroid use were higher among male ( 4.08 % ) than female students ( 1.2 % ) . Students living in the South ( 3.46 % ) reported higher prevalences than students in the Midwest ( 3.0 % ) , West ( 2.02 % ) , or Northeast ( 1.71 % ) . Students with self-perceived below-average academic performances ( 5.10 % ) and students reporting injected drug use also reported higher anabolic-steroid use ( 51.57 % ) . Based on a multiple logistic regression , the following variables were found to be significant predictors of anabolic-steroid use : injectable drug use ( odds ratio [ OR ] , 17.86 ) , use of other drugs ( OR , 4.19 ) , male gender ( OR , 2.79 ) , alcohol use ( OR , 1.38 ) , and strength training ( OR , 1.73 ) . The variables that were significantly associated with anabolic-steroid use varied by gender and by region of the country . CONCLUSION These data suggest that adolescent anabolic-steroid users in this country are more likely to engage in strength training , injected drug use , and the use of multiple drugs , even after controlling for sports participation and poorer academic performance . These data confirm previous findings of an association between multiple drug use and anabolic-steroid use . Also , engaging in strength-training exercises continued to be associated with anabolic-steroid use after controlling for drug use and other predictors",
"The opinions ( level of agreement ) of high school varsity football players with regard to reported effects of anabolic steroids were assessed before and after two different education interventions . Lectures and h and outs of a balanced education program ( potential risks and benefits ) were compared with a risks-only ( negative or \" scare tactics \" ) presentation , in a controlled manner . Those receiving the balanced review significantly increased their agreement with 5 of 10 targeted adverse effects , while no change occurred for any risks among those taught by the negative intervention . A teaching model that only emphasizes the untoward consequences of anabolic steroids is ineffective , even in the short-term . A balanced education approach can improve underst and ing of the potential adverse effects of these drugs . Additional strategies may be required to change young athletes ' attitudes toward anabolic and rogenic steroid use"
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411748c6-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES This review documented the range and nature of reported outcome measures in the context of adult auditory rehabilitative research . DESIGN A scoping review conducted as a part of the development of a systematic review of the effect of interventions to improve hearing aid use . The authors search ed the Cochrane Ear , Nose and Throat Disorders Group Trials Register ; the Cochrane Central Register of Controlled Trials ; PubMed ; EMBASE ; CINAHL ; Web of Science ; Cambridge Scientific Abstract s ; ICTRP ; and additional sources for published and unpublished r and omized control trials . The date of the search was November 6 , 2013 . Outcomes were grouped using a framework suggested by the Cochrane Effective Practice and Organization of Care group . RESULTS Patient outcomes included adherence to hearing aid use , daily hours of aid use , hearing h and icap , hearing aid benefit , quality of life , and communication and psychological outcome . Satisfaction and speech perception were frequent secondary outcomes . There was diversity in measures used to report patient outcomes . Outcome categories other than patient health status and behavior were rarely reported . The timing of outcome measurement was often short term ( 1 year ) . CONCLUSIONS This review has highlighted considerable diversity in patient-reported outcome measurements in r and omized control trials in the context of adult auditory rehabilitation . In addition , there are gaps in the literature with respect to measurement of other outcome types of potential interest to stakeholders , including policymakers and commissioners . Long-term outcome assessment is rare
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"This paper addresses the development and effectiveness of a home education program . The program , design ed for hearing-impaired elders and their significant others ( SO ) , deals with communication strategies and speech reading . Participants were r and omly assigned to a training group ( hearing aid fitting + home education program ) or a control group ( hearing aid fitting ) . The training group included 24 hearing-impaired subjects and 24 SO 's . Controls were 24 affected individuals and 22 SO 's . Question naires addressing emotional response , communication strategies and the IOI-HA , IOI-AI and IOI-SO were used . A repeated measures analysis of variance was applied to test group differences between pre , post , and 6-months follow-up measures . Increased awareness of benefits of speech reading and improved interaction with the SO were observed in the training group only ( p ‘ emotional response ’ was found . IOI-AI and IOI-SO demonstrated favorable attitudes towards the program . Follow-up measures showed improved quality of life and satisfaction in the training group , while a decrease was observed among the controls ( p < 0.05 ) . Some effects differed between first-time and experienced hearing aid users . Addition of services to amplification and involvement of the SO are relevant in aural rehabilitation",
"BACKGROUND Audiologic rehabilitation aims to improve communication for people with hearing impairment . Education is widely regarded as an integral part of rehabilitation , but the effect of the delivery method of an educational program on the experience of hearing problems has rarely been investigated in controlled trials . PURPOSE The purpose of this study was to examine the short-term effects of complementing an educational program for hearing aid users with telephone consultations , delivered through weekly discussion s with the subjects about information obtained from a book on hearing and hearing aids . RESEARCH DESIGN This study used a r and omized , controlled design . STUDY SAMPLE In total , 69 hearing aid users were r and omly assigned to an intervention group ( n = 33 ) or a control group ( n = 36 ) . INTERVENTION The intervention group had access to a book and received weekly topic-based reading instructions related to the different chapters of the book . Five telephone calls were made to the members of the intervention group . During the calls , an audiologist discussed new information with the participant as needed . The control participants also read the book , but they did not discuss the contents of the book with a professional . DATA COLLECTION AND ANALYSIS The Hearing H and icap Inventory for the Elderly ( HHIE ) , the Hospital Anxiety and Depression Scale ( HADS ) , and the International Outcome Inventory for Hearing Aids ( IOI-HA ) were used to measure the outcomes of this study . RESULTS Participants in the intervention group had a reduction in self-reported hearing h and icap , while there were no significant changes in the control group . In the intervention group , 45 % of the participants showed an improvement of ≥36 % on the HHIE , while only 17 % of the control group showed an improvement of ≥36 % . There were also improvements on the HADS total and the depression subscale for the intervention group . No changes occurred on the IOI-HA . CONCLUSIONS Reading about hearing and hearing aids can reduce the hearing h and icap and reported anxiety in hearing aid users . In this study , discussing the content of the book that was provided with a professional during weekly telephone consultations and having weekly home assignments further improved emotional well-being , as demonstrated by the HHIE ( emotional scale ) and HADS ( depression scale ) , but these activities had no effect on hearing aid outcomes as measured by the IOI-HA",
"Auditory training has long been advocated to enhance communication but has never been time or cost-effective . This article describes the concepts underlying the development of a home-based , interactive adaptive computer program design ed to engage the adult hearing-impaired listener in the hearing-aid-fitting process , provide listening strategies , build confidence , and address cognitive changes characteristic of the aging process . An investigation using a between-group , within-subject design with pre- and post-test objective and subjective measures was conducted at five clinical sites . Sixty-five subjects were r and omly placed into two groups , one receiving LACE ( Listening and Communication Enhancement ) immediately following baseline testing and one serving as a control for one month and then receiving training as a crossover group . Results showed statistically significant improvements for the trained subjects on all but one of the outcome measures . Barriers facing the widespread implementation of home-based aural rehabilitation are discussed",
"Objective : To examine short- and long-term subjective benefits of providing a counseling-oriented audiological rehabilitation ( AR ) program as an adjunct to hearing aid intervention for individuals with adult-onset hearing loss . Design : One hundred six veterans ( 68 men and 38 women ) , fit binaurally with digitally programmable analog hearing aids , participated . The Communication Profile for the Hearing Impaired ( CPHI ; Demorest & Erdman , 1987 ) was administered to all participants before hearing aid fitting . Half the patients were r and omly assigned to receive hearing aids alone ( i.e. , control ) ; the other patients were assigned to participate in a 4-wk group AR program in conjunction with receiving hearing aids ( i.e. , HA+AR ) . At the end of the AR program , the CPHI was again administered to all participants to assess short-term benefit and at 6 mo and 1 yr after hearing aid fitting to assess long-term benefit . Results : A separate repeated- measures version of the general linear model was used to examine short- and long-term benefits for the CPHI factor scores ( communication importance , communication performance , adjustment , interaction , and reaction ) and for individual importance ratings and scale scores . Hearing aid use improved both short- and long-term self-perception of communication performance , with no additional benefits from participation in the AR program . Consistent with the goals of a counseling-oriented AR program , differential short-term treatment effects were found for communication strategy usage , which led to differential short-term benefits for the interaction and reaction factors . Although failing to reach strict criteria for statistical significance , there was an observable difference in short-term outcomes between the two groups for the adjustment factor , with greater improvements occurring for the HA+AR group . Over the course of the year , benefits measured for the HA+AR group remained stable , whereas scores for the control group continued to increase , result ing in no differences in factor scores between groups at 1 yr after intervention . Conclusions : The finding of a short-term differential treatment benefit for AR in terms of interaction and reaction , and possibly for adjustment , was important , as better outcomes in these areas may be important in the decision to keep hearing aids . If this is the case , then the data support the inclusion of a counseling-oriented AR program . Differential treatment effects in interaction and reaction appeared to result from communication strategy use , indicating that the AR program is meeting many of its goals in this area . The lack of long-term differential effects appeared as the result of continued changes in adjustment , interaction , and reaction with continued hearing aid experience ",
"PURPOSE To attempt to determine whether group audiologic rehabilitation ( AR ) content affected psychosocial outcomes . METHOD A r and omized controlled trial with at least 17 participants per group was completed . The 3 treatment groups included a communication strategies training group , a communication strategies training plus psychosocial exercise group , and an informational lecture plus psychosocial exercise group . Evaluations were conducted preclass , postclass , and 6-months postclass ; they included hearing loss-related and generic quality of life scales , and a class evaluation form . RESULTS All treatment groups demonstrated short- and long-term improvement on the hearing loss-related quality of life scale . Minimal differences were measured across treatment groups . A significant difference was observed between the lecture plus psychosocial exercise group and the communication strategies training group for 1 hearing loss-related quality of life subscale . Better outcomes were measured for the 2 groups with psychosocial exercises versus the communication strategies training group on 1 generic quality of life subscale . The results for the class evaluation did not discriminate among the treatment groups . CONCLUSIONS Class content had only a minimal influence on treatment outcomes . Recommended AR class content includes a mix of interventions including information , training , and psychosocial exercises",
"Results of this study demonstrate the advantages of both pre- and postfitting hearing aid orientation ( HAO ) sessions . This study demonstrated that HAO counseling is helpful in expediting hearing aid benefit and satisfaction through the education of our clients and that this benefit and satisfaction is age dependent as measured by the Glasgow Hearing Aid Benefit Profile ( GHABP ) ( Gatehouse , 1997 ) . Patients with greater initial disability , as identified by item 1 of the GHABP , receive significant benefit from prefitting and /or postfitting counseling as compared to patients receiving no counseling . Implication s of these findings are discussed",
"BACKGROUND Since the psychosocial effects of hearing loss are different in the spouse ( SP ) than in the person with hearing loss ( PHL ) , it seems reasonable that rehabilitation programs design ed for PHLs may need to be adapted to benefit SPs . PURPOSE To evaluate the effectiveness of training in communication strategies and psychosocial exercises for SPs of PHLs by determining whether SPs who completed the group class had improved mood , reduced stress , improved marital communication , and greater awareness of their partners ' hearing loss-related quality of life ( HL-QOL ) in comparison with SPs who did not participate in a group class . Additionally , to determine whether PHLs of SPs who participated in a group audiological rehabilitation ( AR ) class had significantly improved mood , reduced stress , improved marital communication , and better HL-QOL scores in comparison with PHLs whose SPs did not participate in a group class . RESEARCH DESIGN A r and omized controlled study . STUDY SAMPLE A total of 72 individuals participated in the study , 36 PHLs and 36 SPs . The PHLs were hearing aid users or cochlear implant users ; the SPs had normal or near normal hearing . INTERVENTION PHLs in the control group participated in a traditional group AR program while their SPs received no treatment . PHLs in the experimental group also participated in a traditional group AR program while their SPs participated in a treatment program design ed for SPs of PHLs . Classes consisted of 90 min sessions meeting once a week for four weeks . DATA COLLECTION AND ANALYSIS All participants completed question naires measuring HL-QOL ( the SPs filled out third-party reports of HL-QOL ) , stress , mood ( positive affect and negative affect ) , and communication in the marriage . Scales were completed three times : prior to the AR program , within two weeks after completing the AR program , and 6 mo later . SP awareness of their PHL 's HL-QOL was measured by comparing preclass and 6 mo scores with reported critical difference values . Preclass , postclass and 6 mo data were examined with repeated measures ANOVAs . RESULTS All SPs reported significant improvements in third-party HL-QOL between the preclass and postclass visit . At the 6 mo visit , these reports remained consistent in the control SPs but declined in the experimental SPs . Awareness of HL-QOL in PHLs was improved in SPs who participated in AR classes and remained consistent in SPs who did not . All SPs demonstrated a trend ( moderate effect sizes ) for decreased stress and decreased negative affect after they and /or their partners completed the AR program . All PHLs demonstrated significant improvements in HL-QOL , significant reductions in stress , significant decreases in negative affect , and significant improvements in marital communication . There were no differences in outcome across the experimental and control PHLs . CONCLUSIONS When PHLs participate in an AR program , they receive significant improvements in QOL ( quality of life ) . Congruence ( as defined by similar scores ) between SP and PHL assessment s of HL-QOL improved in the experimental group , suggesting that the principal impact of the AR program on SPs was improved underst and ing of PHL experiences with hearing loss",
"PURPOSE This study attempted to determine whether auditory-only and auditory-visual speech perception could be trained in a group format . METHOD A r and omized controlled trial with at least 16 participants per group was completed . A training-only group completed at least 5 hr of group speech perception training ; a training plus psychosocial group completed at least 5 hr of group speech perception training and psychosocial exercises ; and a control group did not receive training . Evaluations were conducted before and after training and included analytic and synthetic measures of speech perception , hearing loss-related and generic quality of life scales , and a class evaluation form . RESULTS No significant group changes were measured on any of the analytic auditory-only or auditory-visual measures of speech perception , yet the majority of training participants ( regardless of training group ) reported improvement in auditory and auditory-visual speech perception . The training participants demonstrated a significant reduction on the emotional subscale of the hearing loss-related quality of life scale , while the control participants did not demonstrate a change on this subscale . CONCLUSIONS Benefits of group audiologic rehabilitation classes may not result from an actual improvement in auditory or visual speech perception abilities , but participants still perceive training in these areas as useful",
"We assessed the effects of perceptual training of syllable identification in noise on nonsense syllable test ( NST ) performance of new ( Experiment 1 ) and experienced ( Experiment 2 ) hearing aid ( HA ) users with sensorineural hearing loss . In Experiment 1 , new HA users were r and omly assigned to either immediate training ( IT ) or delayed training ( DT ) groups . IT subjects underwent 8 weeks of at-home syllable identification training and in-laboratory testing , whereas DT subjects underwent identical in-laboratory testing without training . Training produced large improvements in syllable identification in IT subjects , whereas spontaneous improvement was minimal in DT subjects . DT subjects then underwent training and showed performance improvements comparable with those of the IT group . Training-related improvement in NST scores significantly exceeded improvements due to amplification . In Experiment 2 , experienced HA users received identical training and testing procedures as users in Experiment 1 . The experienced users also showed significant training benefit . Training-related improvements generalized to untrained voices and were maintained on retention tests . Perceptual training appears to be a promising tool for improving speech perception in new and experienced HA users",
"Two methods of fine tuning the initial setting s of hearing aids were compared : An audiologist-driven approach––using real ear measurements and a patient-driven fine-tuning approach––using feedback from real-life situations . The patient-driven fine tuning was conducted by employing the Amplifit ® II system using audiovideo clips . The audiologist-driven fine tuning was based on the NAL-NL1 prescription rule . Both setting s were compared using the same hearing aids in two 6-week trial periods following a r and omized blinded cross-over design . After each trial period , the setting s were evaluated by insertion-gain measurements . Performance was evaluated by speech tests in quiet , in noise , and in time-reversed speech , presented at 0 ° and with spatially separated sound sources . Subjective results were evaluated using extensive question naires and audiovisual video clips . A total of 73 participants were included . On average , higher gain values were found for the audiologist-driven setting s than for the patient-driven setting s , especially at 1000 and 2000 Hz . Better objective performance was obtained for the audiologist-driven setting s for speech perception in quiet and in time-reversed speech . This was supported by better scores on a number of subjective judgments and in the subjective ratings of video clips . The perception of loud sounds scored higher than when patient-driven , but the overall preference was in favor of the audiologist-driven setting s for 67 % of the participants",
"UNLABELLED It is of paramount importance to install hearing rehabilitation programs for the elderly . AIM To check the efficacy of a forma auditory training program for elderly patients fitted with hearing aids for at least three months , by means of speech recognition tests and self- assessment question naires . METHODS Longitudinal contemporary cohort study . We selected 13 elderly hearing aid users , using intra-canal hearing aids in both ears , from both genders , with average age of 65.3 years . This group was r and omly divided in Experiment Group and Control Group . The Experiment Group underwent seven formal auditory training sessions , aim ing at stimulating their hearing skills for hearing closing , memory , attention , background figure and binaural integration . The participants were assessed by three behavioral tests and one self assessment question naire . RESULTS The elderly from the Experiment Group had significantly better performance in the assessment s after auditory training in comparison to the Control Group . CONCLUSION The formal auditory training program in a soundproof booth , associated with the use of hearing aids , improves speech recognition performance and reduces the perception of auditory h and icap for the elderly who use intra-canal hearing aids",
"BACKGROUND By using the Internet in the audiological rehabilitation process , it might be possible in a cost-effective way to include additional rehabilitation components by informing and guiding hearing aid users about such topics as communication strategies , hearing tactics , and how to h and le hearing aids . PURPOSE To evaluate the effectiveness of an online education program for adult experienced hearing aid users including professional guidance by an audiologist and compare it with the effects of participation in an online discussion forum without any professional contact . RESEARCH DESIGN A r and omized controlled study with two groups of participants . Repeated measures at pre study , immediate follow-up , and a 6 mo follow-up . STUDY SAMPLE Fifty-nine experienced hearing aid users participated in the study , ranging in age from 24 to 84 yr ( mean 63.5 yr ) . INTERVENTION The intervention group ( N = 29 ) underwent a five-week rehabilitative online education in which activities for each week included information , tasks , and assignments , and contact with a professional audiologist was included . The participants in the control group ( N = 30 ) were referred to an online discussion forum without any audiologist contact . DATA COLLECTION AND ANALYSIS A set of question naires administered online were used as outcome measures : ( 1 ) Hearing H and icap Inventory for the Elderly , ( 2 ) International Outcome Inventory for Hearing Aids , ( 3 ) Satisfaction with Amplification in Daily Life , and ( 4 ) Hospital Anxiety and Depression Scale . RESULTS Significant improvements measured by the Hearing H and icap Inventory for the Elderly were found in both groups of participants , and the effects were maintained at the 6 mo follow-up . The results on the Hospital Anxiety and Depression Scale showed that the participants in the intervention group showed reduced symptoms of depression immediately/6 mo after the intervention . At the 6 mo follow-up participants in the control group reported fewer symptoms of anxiety than they did before the intervention started . CONCLUSIONS This study provides preliminary evidence that the Internet can be used to deliver education to experienced hearing aid users who report residual hearing problems such that their problems are reduced by the intervention . The study also suggests that online discussion forums could be used in rehabilitation . A combination of online professional supervised education and online informal discussion s could be a promising rehabilitation tool",
"The purpose of this study was to determine whether periodic clinician-initiated telephone contact would reduce the number of unresolved complaints and increase satisfaction , use , and perceived benefit at 4 mo postfitting . Thirty subjects were contacted at 6 , 9 , and 12 wk postfitting to address questions and to encourage them to return to the clinic to resolve hearing aid-related problems . A control group of 30 subjects was encouraged to contact the center if problems arose at the time of dispensing only . All subjects were interviewed at 4 mo following receipt of the aids , and were sent the Hearing H and icap Inventory for the Elderly at the same time as well as at the time of dispensing . Results revealed a significant reduction in perceived h and icap in general , but no significant difference between groups on measures of satisfaction , use , or benefit . There was no significant difference between groups in the number of unresolved complaints at the time of the interview ; however , a trend toward fewer complaints in the experimental group was noted . A significantly greater number of complaints were raised for the first time in the control group than in the experimental group at the time of the interview , indicating that more problems remained unaddressed in the absence of clinician-initiated intervention . Therefore , the continued investigation of aggressive , and efficient , postfitting management schemes is warranted",
"BACKGROUND Numerous studies have demonstrated that improving the ability to underst and speech in noise can be a difficult task for adults with hearing aids ( HAs ) . If HA users want to improve their speech underst and ing ability , specific training may be needed . Auditory training ( AT ) is one type of intervention that may enhance speech recognition abilities for adult HA users . PURPOSE The purpose of this study was to examine the behavioral effects of an AT program called Listening and Communication Enhancement ( LACE ) in the DVD format in new and experienced HA users . While some research has been conducted using the computer version of this program , no research to date has been conducted on the efficacy of the DVD version of the LACE training program in both new and experienced HA users . RESEARCH DESIGN An experimental , prospect i ve repeated measures group design , with r and om assignment . STUDY SAMPLE Twenty-nine adults with hearing loss were assigned to one of three groups : new HA plus training , experienced HA plus training , or control ( new HA users with no training during the study but provided with training afterward ) . New HA aid users were r and omly assigned to either the training or control group . INTERVENTION Participants in the training groups completed twenty 30 min training lessons from the LACE DVD program at home over a period of 4 wk . DATA COLLECTION Participants in both training groups were evaluated at baseline , after 2 wk of training and again after 4 wk of training . Participants in the control group were evaluated at baseline and after 4 wk of HA use . Several objective listening measures were administered including speech in noise , rapid speech , and competing sentences tasks . Subjective measures included evaluating the participants ' perception of the intervention as well as their perceptions of functional listening abilities . RESULTS Findings indicate that both new and experienced users improved their underst and ing of speech in noise , underst and ing of competing sentences , and communication function after training in comparison to a control group . Effect size calculations suggested that a larger training effect was observed for new HA users compared to experienced HA users . New HA users also reported greater benefit from training compared to experienced users . AT with the LACE DVD format should be encouraged , particularly among new HA users , to improve underst and ing in difficult listening conditions",
"Rehabilitation of the majority of hearing h and icapped in Sweden consists of hearing aid fitting , provision of technical devices and information during about four visits to a Hearing Centre . Generally there is no structured guidance of the hearing h and icapped on how to proceed with the hearing aid at home between appointments . A programme of active fitting ( AF ) of hearing aids , with a task-oriented diary , ' Try Your Hearing Aid ' as a basic part , was therefore developed . We conducted a series of studies from 1985 to 1988 with the aim of investigating the benefit and applicability of the programme . A total of 128 new hearing aid c and i date s participated in three studies at the Sahlgrens hospital and at four other hearing centres in smaller Swedish towns . In a controlled study the AF group was more positive to their hearing aids and to the fitting period after 10 months . They used their hearing aids more frequently and felt psychologically more secure with them . It was established that the AF programme could well be applied in the clinical routine for a majority of new hearing aid patients . Old age per se was not found to be a relevant exclusion criterion . The positive outcome of the AF programme has stimulated the Swedish Institute of the H and icapped to print ' Try Your Hearing Aid ' with a manual , and to introduce it to all hearing centres in Sweden",
"PURPOSE To evaluate teleconsultation 's efficacy for hearing aid fitting . METHODS Fifty hearing impaired individuals with ages ranging from 39 to 88 years and mean audiometric thresholds between 30 and 68.75 dBHL participated in this study . Participants were divided into two groups ( stratified r and omization ) : control group ( n=25 ) , su bmi tted to face-to-face procedures , and experimental group ( n=25 ) , su bmi tted to synchronous teleconsultation with interactive video and remote applicative control . The hearing aids were programmed and verified ( with microphone probe ) , and the subjects received instructions regarding use and care for the device . Time taken for the procedures was measured . Following the consultations , an evaluator ( blind to the groups ) applied the Hearing in Noise Test ( HINT-Brazil ) . Approximately one month after consultations , the daily time of hearing aid use was verified , and the International Outcome Inventory for Hearing Aids ( IOI-HA ) was administered . RESULTS A greater time for programming and verification and a smaller time for orientation were observed for the experimental group . No difference was found between groups for the total consultation time . The real ear measures ' matching to their respective targets was similar for both groups . No difference was observed between groups for the HINT results ( silence and noise ) , the daily amount of use of hearing aids in hours , and the IOI-HA scores . CONCLUSION Teleconsultation is an efficient procedure for hearing aid programming , verification and fitting when face-to-face services are not available",
"BACKGROUND Data suggest that having high expectations about hearing aids results in better overall outcome . However , some have postulated that excessively high expectations will result in disappointment and thus poor outcome . It has been suggested that counseling patients with unrealistic expectations about hearing aids prior to fitting may be beneficial . Data , however , are mixed as to the effectiveness of such counseling , in terms of both changes in expectations and final outcome . PURPOSE The primary purpose of this study was to determine whether supplementing prefitting counseling with demonstration of real-world listening can ( 1 ) alter expectations of new hearing aid users and ( 2 ) increase satisfaction over verbal-only counseling . Secondary goals of the study were to examine ( 1 ) the relationship between prefitting expectations and postfitting outcome , and ( 2 ) the effect of hearing aid fine-tuning on hearing aid outcome . RESEARCH DESIGN Sixty new hearing aid users were fitted binaurally with Beltone Oria behind-the-ear digital hearing aids . Forty participants received prefitting counseling and demonstration of listening situations with the Beltone AVE ( Audio Verification Environment ) system ; 20 received prefitting counseling without a demonstration of listening situations . Hearing aid expectations were measured at initial contact and following prefitting counseling . Reported hearing aid outcome was measured after eight to ten weeks of hearing aid use . STUDY SAMPLE Sixty new hearing aid users aged between 55 and 81 years with symmetrical sensorineural hearing loss . INTERVENTION Participants were r and omly assigned to one of three experimental groups , between which the prefitting counseling and follow-up differed : Group 1 received prefitting counseling in combination with demonstration of listening situations . Additionally , if the participant had complaints about sound quality at the follow-up visit , the hearing aids were fine-tuned using the Beltone AVE system . Group 2 received prefitting counseling in combination with demonstration of listening situations with the Beltone AVE system , but no fine-tuning was provided at follow-up . Group 3 received prefitting hearing aid counseling that did not include demonstration of listening , and the hearing aids were not fine-tuned at the follow-up appointment . RESULTS The results showed that prefitting hearing aid counseling had small but significant effects on expectations . The two forms of counseling did not differ in their effectiveness at changing expectations ; however , anecdotally , we learned from many participants that that they enjoyed listening to the auditory demonstrations and that they found them to be an interesting listening exercise . The data also show that positive expectations result in more positive outcome and that hearing aid fine-tuning is beneficial to the user . CONCLUSIONS We conclude that prefitting counseling can be advantageous to hearing aid outcome and recommend the addition of prefitting counseling to address expectations associated with quality of life and self-image . The data emphasize the need to address unrealistic expectations prior to fitting hearing aids cautiously , so as not to decrease expectations to the extent of discouraging and demotivating the patient . Data also show that positive expectations regarding the impact hearing aids will have on psychosocial well-being are important for successful hearing aid outcome",
"We design ed this noninferiority r and omized trial to determine ( 1 ) if group hearing aid fitting visits and group hearing aid follow-up visits were at least as effective as individual visits in terms of hearing-related function ( measured with the Inner Effectiveness of Auditory Rehabilitation [ EAR ] scale ) and adherence , and ( 2 ) if group visits were less costly over the 6 mo post-fitting period . For 644 participants r and omized to receive their hearing aid visits in an individual or group format at the Department of Veterans Affairs Puget Sound Health Care System , 6 mo outcomes showed no significant differences in Inner EAR scores between individual and group fitting ( p = 0.53 ) or follow-up ( p = 0.11 ) , or in the number of hours per day hearing aids were worn between individual and group fitting ( p = 0.90 ) or follow-up ( p = 0.24 ) . We found significantly higher cost for individual compared with group fitting ( p < 0.001 ) and follow-up ( p < 0.001 ) . We conclude that outcomes for group hearing aid fitting and hearing aid follow-up visits were not inferior to individual hearing aid fitting and follow-up visits , with group fitting and follow-up visits yielding cost savings",
"Nineteen elderly hearing impaired subjects participated in an experimental treatment study and received either behavioural hearing tactics or served as untreated controls . Treatment was supplied in the form of a self-help treatment manual supplied with telephone contacts during 4 consecutive weeks . The treatment manual included applied relaxation , communication strategies training , advice to relatives , information , and coping skills . Assessment s ( pre-post ) were conducted in a structured interview measuring coping behaviour . In order to evoke behavioural compensation small acoustic provocations were included in the interview . Pre-post assessment s also included question naires , daily registered hearing problems , and hours of daily hearing aid use . Results showed significant beneficial effects in favour of the treatment in terms of self-assessed problems and behaviour change",
"Many centres include a communication course as part of their auditory rehabilitation . These usually take the form of a small group and include discussion of the effects of hearing loss , use of the hearing aid , hearing tactics and lip reading . To investigate the efficacy of such a rehabilitation programme a r and omized , controlled trial of a communication course was undertaken . All subjects were first time hearing aid users ; h and icap was measured using the Quantified Denver Scale of Communication Function ( QDS ) at the time of hearing aid fitting , and then 13 weeks later . All subjects had a hearing aid follow-up appointment , but the treatment group ( n = 22 ) also underwent a four-week communication course , while the control group ( n = 25 ) had no further rehabilitation . The reduction in h and icap measured by the change in QDS was significantly greater for the treatment group than for the control group ( Mann Whitney U test , tied p value = 0.014 ) . This indicates that such a communication course is efficacious in reducing h and icap . Further research is required to identify the population s that will benefit most from such a course",
"BACKGROUND Reduced hearing in elderly people is important because it is disabling and potentially treatable . We aim ed to assess the prevalence of reduced hearing in elderly people and levels of ownership of hearing aids and use . METHODS We have done a cross-sectional survey of people aged at least 75 years in 106 family practice s in the UK . We obtained self-reported data on hearing difficulties for 32,656 people and gave 14,877 a whispered voice test ( response rate 78 % ) . FINDINGS 2537 ( 8 % ) of 32,656 participants reported a lot of difficulty hearing and 13,630 ( 42 % ) a little or a lot of difficulty . 3795 ( 26 % ) of 14877 participants who completed the whispered voice test ( 95 % CI 23 - 29 ) failed the test , the proportion rising sharply with age . Following wax removal , 343 passed a retest , leaving 3452 ( 23 % , 20 - 26 ) who failed the test , even after wax removal if present . 998 ( 46 % ) of 2180 people wearing a hearing aid at the time of testing failed the whispered voice test . More than half the people who failed the test did not own a hearing aid . 2200 ( 60 % ) of 3846 people who owned a hearing aid said they used it regularly . Level of use was strongly related to perceived benefit . INTERPRETATION Reduced hearing is common and provision of hearing aids inadequate in elderly people . Many people who own a hearing aid do not use it regularly , and even when wearing their aid many still have socially disabling levels of hearing loss . A major source of morbidity in elderly people could be alleviated by improvements in detection and management of reduced hearing",
" Twenty-four elderly hearing impaired Ss participated in an experimental treatment study and received either behavioural group treatment or served as untreated controls . The treatment package included applied relaxation , video self-modelling , exposure , information and various coping skills . Assessment s ( pre-post ) were conducted using a structured video-interview measuring coping behaviour . In order to evoke behavioural compensation small acoustic provocations were included in the interview . The edited videos were then rated blindly by two trained observers . Pre-post assessment s also included daily registered hearing problems on visual analogue scales and a question naire . Finally , a one month follow-up blind telephone interview was conducted . Results showed significant beneficial effects in favour of the treatment package and support the implementation of a behavioural approach in audiological rehabilitation research",
"OBJECTIVE To develop a new scale of hearing-related function and quality of life in patients with hearing aids that addresses overlooked concerns , such as hearing-aid comfort , convenience , and cosmetic appearance , that may influence hearing-aid adherence while maintaining brevity and sensitivity to clinical change . DESIGN Prospect i ve , multicenter instrument validation . SETTING Four diverse sites in Washington State , including 2 private practice s , 1 university setting , and 1 Veterans Affairs hospital . PATIENTS Seventy-eight patients with hearing aids . INTERVENTIONS We created 2 modules in the Effectiveness of Auditory Rehabilitation ( EAR ) scale . The first module ( Inner EAR ) covers intrinsic hearing issues such as hearing in quiet and hearing in noise and is administered both before and after treatment . The second module ( Outer EAR ) covers extrinsic ( hearing-aid related ) issues such as comfort , appearance , and convenience and is administered after hearing-aid fitting . MAIN OUTCOME MEASURES Both scales were developed and vali date d in 3 stages . Stage 1 used a qualitative approach from multiple data sources to develop preliminary instruments . Stage 2 used approaches from classic test theory to reduce the number of items and psychometrically vali date the instruments . Stage 3 examined the responsiveness or sensitivity to clinical change . RESULTS A 10-item Inner EAR module and a 10-item Outer EAR module were created and vali date d. Internal consistency of individual domains ( Cronbach alpha = 0.85 and 0.72 , respectively ) and test-retest reliability ( intraclass correlation coefficients = 0.76 and 0.81 , respectively ) were excellent . Evidence of construct validity included concurrent validity with other hearing scales and global visual analog scales , discriminant validity with dizziness h and icap , correlation with hearing-aid adherence , and confirmatory factor analyses . Both scales had strong evidence of responsiveness ( sensitivity to change ) , with higher effect sizes and Guyatt responsiveness statistics than the 2 widely used hearing scales in this study . The scales took an average of 5 minutes to complete . CONCLUSIONS The EAR scale is a valid and reliable measure of the effectiveness of amplification in the treatment of sensorineural hearing loss . It addresses the range of issues that are of importance to hearing-aid patients . The scales have excellent psychometric properties , are more responsive than several widely used hearing scales , and are minimally burdensome for patients to complete . The EAR may be a valuable outcome measure in future studies of both existing hearing aids and newer hearing-aid technologies , such as bone-anchored aids or middle ear implants",
"Effects of behavioral counselling of subjects with an acquired hearing loss were evaluated in an experimental design . The study included a group of 20 hearing-impaired subjects who were assessed and r and omly allocated to a treatment or control group . Behavioural counselling , individualized according to the results of functional analysis , was then given to 10 subjects and included the teaching of ' hearing tactics ' . The groups were measured three times , pre-counselling and post-counselling and at a 15-month follow-up , after which treatment results were analysed . Significant ( time x treatment ) interactions were followed by post-hoc testing revealing that the treated group had improved in several areas of functioning while controls had not . These results were in agreement with interview data . The findings indicate that a behavioural counselling approach to hearing tactics is beneficial in the underst and ing and rehabilitation of hearing loss , especially over time",
"The effect of a short instructional session on people 's knowledge of hearing tactics was tested on a sample of hearing-aid users 65 years of age and over . They had had their hearing aids for 3 months . A question naire was administered before and after the instruction session and the difference in score taken as a measure of the effect of instruction . A high score on the question naire indicated a lack of appropriate knowledge . Only those who scored incorrectly on one or more questions were given instruction . People were allocated at r and om either into an instructed group or a control group not so instructed . A substantial proportion ( 45 % ) had low initial scores on the question naire . The instruction significantly improved the scores of the experimental groups . The differences in score changes within age groups were not significant but men tended to improve more than women . The re source implication s of the instructional methods are discussed"
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Children obesity is considered a serious public health problem around the world . In Spain , the prevalence of overweight/obesity is reaching alarming figures , exceeding 35 % of the children . Several hypotheses suggest that the energy balance model does not fit very well when analyzing the causes of the current obesity epidemic and , although genetics seems to explain up to 30 % of the likelihood to become obese in infancy , has been suggested that genetics might be influenced by environment factors including vigorous physical activity ( PA ) . Some recent systematic review s indicate that there is enough evidence about the effectiveness of interventions to prevent obesity in children 6 - 12 years old ; however , the heterogeneity of the effect , and the potential selection , information and publication biases that undermine the validity of these studies , thus their results should be interpreted with caution . In Spain , an extracurricular PA program of leisuretime ( MOVI ) has evidence d some effectiveness on reducing the adiposity and on improving the lipid profile in schoolchildren . To overcome some weakness of MOVI program , a second edition of this study was design ed . The objectives of this review are twofold : 1 ) to analyze latest data of the obesity epidemic in Spain ; and 2 ) to describe the main features of MOVI-2 program , and overall of the successful interventions to prevent children obesity
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"OBJECTIVE To evaluate the impact of a school-based health behavior intervention known as Planet Health on obesity among boys and girls in grade s 6 to 8 . DESIGN R and omized , controlled field trial with 5 intervention and 5 control schools . Outcomes were assessed using preintervention ( fall 1995 ) and follow-up measures ( spring 1997 ) , including prevalence , incidence , and remission of obesity . PARTICIPANTS A group of 1295 ethnically diverse grade 6 and 7 students from public schools in 4 Massachusetts communities . INTERVENTION Students participated in a school-based interdisciplinary intervention over 2 school years . Planet Health sessions were included within existing curricula using classroom teachers in 4 major subjects and physical education . Sessions focused on decreasing television viewing , decreasing consumption of high-fat foods , increasing fruit and vegetable intake , and increasing moderate and vigorous physical activity . MAIN OUTCOME MEASURES Obesity was defined as a composite indicator based on both a body mass index and a triceps skinfold value greater than or equal to age- and sex-specific 85th percentiles . Because schools were r and omized , rather than students , the generalized estimating equation method was used to adjust for individual-level covariates under cluster r and omization . RESULTS The prevalence of obesity among girls in intervention schools was reduced compared with controls , controlling for baseline obesity ( odds ratio , 0.47 ; 95 % confidence interval , 0.24 - 0.93 ; P = .03 ) , with no differences found among boys . There was greater remission of obesity among intervention girls vs. control girls ( odds ratio , 2.16 ; 95 % confidence interval , 1.07 - 4.35 ; P = .04 ) . The intervention reduced television hours among both girls and boys , and increased fruit and vegetable consumption and result ed in a smaller increment in total energy intake among girls . Reductions in television viewing predicted obesity change and mediated the intervention effect . Among girls , each hour of reduction in television viewing predicted reduced obesity prevalence ( odds ratio , 0.85 ; 95 % confidence interval , 0.75 - 0.97 ; P = .02 ) . CONCLUSION Planet Health decreased obesity among female students , indicating a promising school-based approach to reducing obesity among youth",
"Objective : To assess the efficacy of a school-based intervention programme to reduce the prevalence of overweight in 6 to 10-year-old children . Design : Cluster-r and omized , controlled study .Subjects : A total of 3135 boys and girls in grade s 1–4 were included in the study . Methods : Ten schools were selected in Stockholm county area and r and omized to intervention ( n=5 ) and control ( n=5 ) schools . Low-fat dairy products and whole-grain bread were promoted and all sweets and sweetened drinks were eliminated in intervention schools . Physical activity ( PA ) was aim ed to increase by 30 min day−1 during school time and sedentary behaviour restricted during after school care time . PA was measured by accelerometry . Eating habits at home were assessed by parental report . Eating disorders were evaluated by self-report . Results : The prevalence of overweight and obesity decreased by 3.2 % ( from 20.3 to 17.1 ) in intervention schools compared with an increase of 2.8 % ( from 16.1 to 18.9 ) in control schools ( P analysis of BMI sds changes . However , a larger proportion of the children who were initially overweight reached normal weight in the intervention group ( 14 % ) compared with the control group ( 7.5 % ) , P=0.017 . PA did not differ between intervention and control schools after cluster adjustment . Eating habits at home were found to be healthier among families with children in intervention schools at the end of the intervention . There was no difference between children in intervention and control schools in self-reported eating disorders . Conclusions : A school-based intervention can reduce the prevalence of overweight and obesity in 6 to 10-year-old children and may affect eating habits at home . The effect of the intervention was possibly due to its effect on healthy eating habits at school and at home rather than on increased levels of PA ",
"OBJECTIVE To evaluate the effect of a 3-year after-school physical activity ( PA ) intervention on aerobic fitness and percent body fat ( % BF ) . METHODS In total , 18 schools were r and omized into intervention or control arms . Measurements were made at the beginning and end of the third , fourth and fifth grade s. Fitness was measured with heart rate response to a bench-stepping task.%BF and bone density were measured with dual-energy x-ray absorptiometry . The intervention included 40 min of academic enrichment activities , during which healthy snacks were provided , and 80 min of moderate-to-vigorous PA ( MVPA ) . RESULTS Data analyses were performed on 206 youths who remained in the same schools for the 3-year period , who were measured at all six time points and , for the intervention group , who attended at least 40 % of the sessions in each of the 3 years . The group by time interactions were significant for fitness ( p Children in intervention schools improved in fitness and % BF during the school years and returned to levels similar to those in control schools during the summers . Over the six measurement points , the intervention group increased more than the control group in bone density ( p fat-free soft tissue ( p weight ( p height ( p body mass index ( p fitness and body composition . During the summers , the beneficial effect of the previous year 's participation on fitness and % BF was lost . This highlights the importance of year-round programs to promote healthy growth in youths",
"CONTEXT Some observational studies have found an association between television viewing and child and adolescent adiposity . OBJECTIVE To assess the effects of reducing television , videotape , and video game use on changes in adiposity , physical activity , and dietary intake . DESIGN R and omized controlled school-based trial conducted from September 1996 to April 1997 . SETTING Two sociodemographically and scholastically matched public elementary schools in San Jose , Calif. PARTICIPANTS Of 198 third- and fourth- grade students , who were given parental consent to participate , 192 students ( mean age , 8.9 years ) completed the study . INTERVENTION Children in 1 elementary school received an 18-lesson , 6-month classroom curriculum to reduce television , videotape , and video game use . MAIN OUTCOME MEASURES Changes in measures of height , weight , triceps skinfold thickness , waist and hip circumferences , and cardiorespiratory fitness ; self-reported media use , physical activity , and dietary behaviors ; and parental report of child and family behaviors . The primary outcome measure was body mass index , calculated as weight in kilograms divided by the square of height in meters . RESULTS Compared with controls , children in the intervention group had statistically significant relative decreases in body mass index ( intervention vs control change : 18.38 to 18.67 kg/m2 vs 18.10 to 18.81 kg/m2 , respectively ; adjusted difference -0.45 kg/m2 [ 95 % confidence interval [ CI ] , -0.73 to -0.17 ] ; P = .002 ) , triceps skinfold thickness ( intervention vs control change : 14.55 to 15.47 mm vs 13.97 to 16.46 mm , respectively ; adjusted difference , -1.47 mm [ 95 % CI , -2.41 to -0.54 ] ; P=.002 ) , waist circumference ( intervention vs control change : 60.48 to 63.57 cm vs 59.51 to 64.73 cm , respectively ; adjusted difference , -2.30 cm [ 95 % CI , -3.27 to -1.33 ] ; P waist-to-hip ratio ( intervention vs control change : 0.83 to 0.83 vs 0.82 to 0.84 , respectively ; adjusted difference , -0.02 [ 95 % CI , -0.03 to -0.01 ] ; P children 's reported television viewing and meals eaten in front of the television . There were no statistically significant differences between groups for changes in high-fat food intake , moderate-to-vigorous physical activity , and cardiorespiratory fitness . CONCLUSIONS Reducing television , videotape , and video game use may be a promising , population -based approach to prevent childhood obesity",
"Background Childhood obesity and physical inactivity are increasing dramatically worldwide . Children of low socioeconomic status and /or children of migrant background are especially at risk . In general , the overall effectiveness of school-based programs on health-related outcomes has been disappointing . A special gap exists for younger children and in high risk groups . Methods / Design This paper describes the rationale , design , curriculum , and evaluation of a multicenter preschool r and omized intervention study conducted in areas with a high migrant population in two out of 26 Swiss cantons . Twenty preschool classes in the German ( canton St. Gallen ) and another 20 in the French ( canton Vaud ) part of Switzerl and were separately selected and r and omized to an intervention and a control arm by the use of opaque envelopes . The multidisciplinary lifestyle intervention aim ed to increase physical activity and sleep duration , to reinforce healthy nutrition and eating behaviour , and to reduce media use . According to the ecological model , it included children , their parents and the teachers . The regular teachers performed the majority of the intervention and were supported by a local health promoter . The intervention included physical activity lessons , adaptation of the built infrastructure ; promotion of regional extracurricular physical activity ; playful lessons about nutrition , media use and sleep , funny homework cards and information material s for teachers and parents . It lasted one school year . Baseline and post-intervention evaluations were performed in both arms . Primary outcome measures included BMI and aerobic fitness ( 20 m shuttle run test ) . Secondary outcomes included total ( skinfolds , bioelectrical impedance ) and central ( waist circumference ) body fat , motor abilities ( obstacle course , static and dynamic balance ) , physical activity and sleep duration ( accelerometry and question naires ) , nutritional behaviour and food intake , media use , quality of life and signs of hyperactivity ( question naires ) , attention and spatial working memory ability ( two vali date d tests ) . Research ers were blinded to group allocation . Discussion The purpose of this paper is to outline the design of a school-based multicenter cluster r and omized , controlled trial aim ing to reduce body mass index and to increase aerobic fitness in preschool children in culturally different parts of Switzerl and with a high migrant population .Trial Registration Trial Registration : clinical trials.gov",
"INTRODUCTION AND OBJECTIVES The MOVI physical activity program has been shown to reduce adiposity and to improve serum lipid profiles in schoolchildren . However , MOVI may have not achieved its maximum potential effectiveness , as increased physical activity on weekdays may have been offset by more sedentary behavior at weekends . We therefore developed the MOVI-2 program , which includes physical activity at weekends as well . This paper reports the rationale and methods of a trial to assess the effectiveness of MOVI-2 in preventing overweight and reducing cardiovascular risk in 1200 4th- and 5th- grade primary schoolchildren in Cuenca , Spain . METHODS Ten schools were r and omly assigned to MOVI-2 and 10 schools to the control group . MOVI-2 consisted of recreational physical activity in after-school time , including two 90-min sessions on weekdays and one 150-min session on Saturdays , during each week of one academic year . The control group was expected to follow their usual patterns of physical activity . The primary end points , which were assessed at the start and the end of the MOVI-2 program , were weight and height , waist circumference , skinfold thickness , body fat percentage , blood pressure , lipid profile , and insulin resistance . Secondary end points were physical activity , fitness , health-related quality of life , sleep quality , academic performance , enjoyment with physical activity , and physical self-concept . CONCLUSIONS This study will assess whether MOVI-2 overcomes some potential limitations of physical activity interventions in children ( Clinical trials.gov number NCT01277224 )",
"Objective To assess the effectiveness of a school based physical activity programme during one school year on physical and psychological health in young schoolchildren . Design Cluster r and omised controlled trial . Setting 28 classes from 15 elementary schools in Switzerl and r and omly selected and assigned in a 4:3 ratio to an intervention ( n=16 ) or control arm ( n=12 ) after stratification for grade ( first and fifth grade ) , from August 2005 to June 2006 . Participants 540 children , of whom 502 consented and presented at baseline . Intervention Children in the intervention arm ( n=297 ) received a multi-component physical activity programme that included structuring the three existing physical education lessons each week and adding two additional lessons a week , daily short activity breaks , and physical activity homework . Children ( n=205 ) and parents in the control group were not informed of an intervention group . For most outcome measures , the assessors were blinded . Main outcome measures Primary outcome measures included body fat ( sum of four skinfolds ) , aerobic fitness ( shuttle run test ) , physical activity ( accelerometry ) , and quality of life ( question naires ) . Secondary outcome measures included body mass index and cardiovascular risk score ( average z score of waist circumference , mean blood pressure , blood glucose , inverted high density lipoprotein cholesterol , and triglycerides ) . Results 498 children completed the baseline and follow-up assessment s ( mean age 6.9 ( SD 0.3 ) years for first grade , 11.1 ( 0.5 ) years for fifth grade ) . After adjustment for grade , sex , baseline values , and clustering within classes , children in the intervention arm compared with controls showed more negative changes in the z score of the sum of four skinfolds ( −0.12 , 95 % confidence interval −0.21 to −0.03 ; P=0.009 ) . Likewise , their z scores for aerobic fitness increased more favourably ( 0.17 , 0.01 to 0.32 ; P=0.04 ) , as did those for moderate-vigorous physical activity in school ( 1.19 , 0.78 to 1.60 ; P ( 0.44 , 0.05 to 0.82 ; P=0.03 ) , and total physical activity in school ( 0.92 , 0.35 to 1.50 ; P=0.003 ) . Z scores for overall daily physical activity ( 0.21 , −0.21 to 0.63 ) and physical quality of life ( 0.42 , −1.23 to 2.06 ) as well as psychological quality of life ( 0.59 , −0.85 to 2.03 ) did not change significantly . Conclusions A school based multi-component physical activity intervention including compulsory elements improved physical activity and fitness and reduced adiposity in children . Trial registration Current Controlled Trials IS RCT N15360785",
"Cardiovascular disease begins early in life but might be prevented or delayed by primary prevention programs design ed for children and adolescents . Regular physical activity is an important part of primary prevention programs , and school physical education programs have potential for the promotion of regular physical activity . Cardiovascular disease is the major cause of death among Hispanics and African Americans in the United States . Low levels of fitness and increased body mass index are common in African American and Hispanic adolescents . Increased physical activity and the adoption of healthy eating habits would increase fitness and reduce body mass index among these adolescents . The purpose of the study was to undertake a small-scale controlled trial to determine if Dance for Health , an intervention program design ed to provide an enjoyable aerobic program for African American and Hispanic adolescents , has a significant effect on improving aerobic capacity , helping students maintain or decrease weight , and on improving attitudes toward physical activity and physical fitness . In the first year of the program ( 1990 - 91 ) , approximately 110 boys and girls ages 10 - 13 years participated in an aerobic dance pilot program three times per week for 12 weeks . Dance for Health was revised and continued in the 1992 - 93 school year with seventh grade students and an added culturally sensitive health curriculum . Forty-three students were r and omized to Dance for Health and 38 to usual physical activity . Those in the intervention class received a health education curriculum twice a week and a dance oriented physical education class three times a week . The usual physical activity consisted mostly of playground activities . Students in the intervention had a significantly greater lowering in body mass index and resting heart rate than students in regular physical activity",
"BACKGROUND Physical Activity Across the Curriculum ( PAAC ) was a three-year cluster r and omized controlled trial to promote physical activity and diminish increases in overweight and obesity in elementary school children . METHODS Twenty-four elementary schools were cluster r and omized to the Physical Activity Across the Curriculum intervention or served as control . All children in grade s two and three were followed to grade s four and five . Physical Activity Across the Curriculum promoted 90 min/wk of moderate to vigorous intensity physically active academic lessons delivered by classroom teachers . Body Mass Index was the primary outcome , daily Physical activity and academic achievement were secondary outcomes . RESULTS The three-year change in Body Mass Index for Physical Activity Across the Curriculum was 2.0+/-1.9 and control 1.9+/-1.9 , respectively ( NS ) . However , change in Body Mass Index from baseline to 3 years was significantly influenced by exposure to Physical Activity Across the Curriculum . Schools with > or = 75 min of Physical Activity Across the Curriculum/wk showed significantly less increase in Body Mass Index at 3 years compared to schools that had Physical Activity Across the Curriculum schools had significantly greater changes in daily Physical activity and academic achievement scores . CONCLUSIONS The Physical Activity Across the Curriculum approach may promote daily Physical activity and academic achievement in elementary school children . Additionally , 75 min of Physical Activity Across the Curriculum activities may attenuate increases in Body Mass Index",
"OBJECTIVE To assess the impact of a 2-year recreational physical activity program in 1044 fourth- and fifth- grade primary schoolchildren from the Province of Cuenca , Spain . STUDY DESIGN Cluster-r and omized controlled trial with 10 intervention and 10 control schools . The program consisted of 3 90-minute sessions of physical activity per week , during 28 weeks every year . Changes in endpoints between baseline ( September 2004 ) and the end of follow-up ( June 2006 ) were compared between the control and intervention group by using mixed regression models , with adjustment for the baseline endpoint value , age , and the school . RESULTS Compared with control subjects , intervention girls reduced the frequency of overweight ( odds ratio , 0.55 ; 95 % CI , 0.39 - 0.78 ; P percentage of body fat in boys ( 0.97 % ; 95 % CI , 0.14 - 1.81 ; P=.02 ) . Girls in the intervention group had lower total cholesterol level ( -6.86 mg/dL ; 95 % CI , -9.70 - -4.01 ; P apolipoprotein B level ( -3.61 mg/dL ; 95 % CI , -6.27 - -0.95 ; P=.008 ) than control subjects . Results were similar in boys . CONCLUSION In 2 years , the physical activity program lowered the frequency of overweight in girls and reduced total cholesterol and apolipoprotein B in both girls and boys",
"Objective : To analyse prevailing food patterns among Spanish children and young people and their relationship to sociodemographic and lifestyle factors . Design : Cross-sectional population survey . Setting : Population study . Data were collected at participants ' home addresses . Subjects : R and om sample of the Spanish population aged 2–24 y ( n=3534 ; 1629 boys and 1905 girls ) . Interventions : Food consumption was assessed by means of a 24-h recall and a food frequency question naire . Sociodemographic and lifestyle related data were collected by specially design ed question naires , previously pretested and vali date d. All the information was collected during a personal interview by trained dietitians . Data collection : May 1998–April 2000 . Results : Average consumption of fruit and vegetables was low . The youngest age group ( 2–5 y ) showed the lowest proportions of inadequacy for the dairy group ( P dietary patterns . The ‘ Snacky ’ pattern was characterised by more frequent and higher consumption of bakery products ( buns , cakes and biscuits ) , sweets , salted snacks and soft drinks . Higher intakes of fruit , vegetables and fish were associated to the ‘ Healthy ’ pattern . Children whose mother had a low level of education and those who spent more than 2 h daily watching TV were more likely to follow the ‘ Snacky ’ pattern . Girls were more likely to follow the ‘ Healthy ’ pattern , while children and young people whose mother had a lower level of education were less likely . Conclusion : Results from this study highlight the importance of enhancing school-based and community-based actions to promote healthy eating and physical activity addressed to children and young people . Sponsorship : This study was supported by Kellogg 's Spain",
"Objectives : To evaluate the effectiveness of an intervention to prevent excess weight gain , reduce time spent in screen behaviours , promote participation in and enjoyment of physical activity ( PA ) , and improve fundamental movement skills among children . Participants : In 2002 , 311 children ( 78 % response ; 49 % boys ) , average age 10 years 8 months , were recruited from three government schools in low socioeconomic areas of Melbourne , Australia . Design : Group-r and omized controlled trial . Children were r and omized by class to one of the four conditions : a behavioural modification group ( BM ; n=66 ) ; a fundamental movement skills group ( FMS ; n=74 ) ; a combined BM/FMS group ( BM/FMS ; n=93 ) ; and a control ( usual curriculum ) group ( n=62 ) . Data were collected at baseline , post intervention , 6- and 12-month follow-up periods . Results : BMI data were available for 295 children at baseline and 268 at 12-month follow-up . After adjusting for food intake and PA , there was a significant intervention effect from baseline to post intervention on age- and sex-adjusted BMI in the BM/FMS group compared with controls ( −1.88 kg m−2 , P overweight/obese between baseline and post intervention ( adjusted odds ratio (AOR)=0.36 , P recorded higher levels and greater enjoyment of PA ; and BM children recorded higher levels of PA and TV viewing across all four time points . Gender moderated the intervention effects for participation in and enjoyment of PA , and fundamental movement skills . Conclusion : This programme represents a promising approach to preventing excess weight gain and promoting participation in and enjoyment of PA . Examination of the mediators of this intervention and further tailoring of the programme to suit both genders is required"
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Abstract Background : The role of probiotics in the treatment of atopic dermatitis ( AD ) remains controversial . A recent systematic review of the available evidence called for further clinical trials with new probiotic formulations . Objective : To assess the clinical efficacy and impact of Lactobacillus acidophilus DDS-1 , Bifidobacterium lactis UABLA-12 with fructo-oligosaccharide on peripheral blood lymphocyte subsets in preschool children with moderate-to-severe AD . Method : R and omized , double-blind , placebo-controlled , prospect i ve trial of 90 children aged 1–3 years with moderate-to-severe AD who were treated with a mixture of L. acidophilus DDS-1 , B. lactis UABLA-12 with fructo-oligosaccharide at a dosage of 5 billion colony-forming units twice daily for 8 weeks versus placebo . The primary outcome measure was the percentage change in Scoring of Atopic Dermatitis ( SCORAD ) value . Other outcome measures were changes in Infant Dermatitis Quality Of Life ( IDQOL ) and Dermatitis Family Impact ( DFI ) scores , frequency and amount of topical corticosteroid used , and lymphocyte subsets in peripheral blood measured by laser flow cytometry . Results : At the final visit , the percentage decrease in SCORAD was 33.7 % in the probiotic group compared with 19.4 % in the placebo group ( p = 0.001 ) . Children receiving probiotic showed a greater decrease in the mean [ SD ] SCORAD score than did children from the placebo group at week 8 ( −14.2 [ 9.9 ] vs −7.8 [ 7.7 ] , respectively ; p = 0.001 ) . IDQOL and DFI scores decreased significantly from baseline by 33.0 % and 35.2 % in the probiotic group and by 19.0 % and 23.8 % in the placebo group , respectively ( p = 0.013 , p = 0.010 ) . Use of topical corticosteroids during the 8-week trial period averaged 7.7 g less in probiotic patients ( p = 0.006 ) . CD3 , CD16 , and CD22 lymphocyte subsets remained unchanged , whereas the percentage of CD4 , and the percentage and absolute count of CD25 decreased , and the percentage and absolute count of CD8 increased in the probiotic group at week 8 ( p between CD4 percentage , CD25 percentage , CD25 absolute count , and SCORAD values ( r = 0.642 , r = 0.746 , r = 0.733 , respectively ; p probiotic mixture containing L. acidophilus DDS-1 , B. lactis UABLA- 12 , and fructo-oligosaccharide was associated with significant clinical improvement in children with AD , with corresponding lymphocyte subset changes in peripheral blood . The efficacy of probiotic therapy in adults with AD requires further investigation
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"BACKGROUND The gastrointestinal microflora is an important constituent of the gut mucosal defense barrier . We have previously shown that a human intestinal floral strain , Lactobacillus GG ( ATCC 53103 ) , promotes local antigen-specific immune responses ( particularly in the IgA class ) , prevents permeability defects , and confers controlled antigen absorption . OBJECTIVE The aim of this study was to evaluate the clinical and immunologic effects of cow 's milk elimination without ( n = 14 ) and with ( n = 13 ) the addition of Lactobacillus GG ( 5 x 10(8 ) colony-forming units/gm formula ) in an extensively hydrolyzed whey formula in infants with atopic eczema and cow 's milk allergy . The second part of the study involved 10 breast-fed infants who had atopic eczema and cow 's milk allergy . In this group Lactobacillus GG was given to nursing mothers . METHODS The severity of atopic eczema was assessed by clinical scoring . The concentrations of fecal alpha 1- antitrypsin , tumor necrosis factor-alpha , and eosinophil cationic protein were determined as markers of intestinal inflammation before and after dietary intervention . RESULTS The clinical score of atopic dermatitis improved significantly during the 1-month study period in infants treated with the extensively hydrolyzed whey formula fortified with Lactobacillus GG . The concentration of alpha 1-antitrypsin decreased significantly in this group ( p = 0.03 ) but not in the group receiving the whey formula without Lactobacillus GG ( p = 0.68 ) . In parallel , the median ( lower quartile to upper quartile ) concentration of fecal tumor necrosis factor-alpha decreased significantly in this group , from 709 pg/gm ( 91 to 1131 pg/gm ) to 34 pg/gm ( 19 to 103 pg/gm ) ( p = 0.003 ) , but not in those receiving the extensively hydrolyzed whey formula only ( p = 0.38 ) . The concentration of fecal eosinophil cationic protein remained unaltered during therapy . CONCLUSION These results suggest that probiotic bacteria may promote endogenous barrier mechanisms in patients with atopic dermatitis and food allergy , and by alleviating intestinal inflammation , may act as a useful tool in the treatment of food allergy",
"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",
"Probiotic bacteria are proposed to alleviate intestinal inflammation in infants with atopic eczema/dermatitis syndrome ( AEDS ) and food allergy . In such infants we investigated effects of probiotic bacteria on faecal IgA , and on the intestinal inflammation markers tumour necrosis factor-alpha ( TNF-alpha ) , alpha1-antitrypsin ( AT ) , and eosinophil cationic protein ( ECP ) . A total of 230 infants with AEDS and suspected cow 's milk allergy ( CMA ) received in a r and omized double-blinded manner , concomitant with elimination diet , Lactobacillus GG ( LGG ) , a mixture of four probiotic strains ( MIX ) , or placebo for 4 wk . Four weeks after treatment , CMA was diagnosed with a double-blind placebo-controlled milk challenge . Faecal sample s of 102 infants , r and omly chosen for analysis , were collected before treatment , after 4-wk treatment , and on the first day of milk challenge . After treatment , IgA levels tended to be higher in probiotic groups than in the placebo group ( LGG vs. placebo , p=0.064 ; MIX vs. placebo , p=0.064 ) , and AT decreased in the LGG group , but not in other treatment groups . After challenge in IgE-associated CMA infants , faecal IgA was higher for LGG than for placebo ( p=0.014 ) , and TNF-alpha was lower for LGG than for placebo , but non-significantly ( p=0.111 ) . In conclusion , 4-wk treatment with LGG may alleviate intestinal inflammation in infants with AEDS and CMA",
"BACKGROUND In the past 20 - 30 years , there has been an increase in prevalence of allergic respiratory diseases , particularly amongst children . This study is a prospect i ve analysis of the postnatal maturation of T-helper cell ( Th ) responses to aeroallergens in atopic and non-atopic infants . METHODS We measured mononuclear-cell proliferative and cytokine responses to specific allergens and tetanus toxoid in blood sample s from atopic and non-atopic infants every 6 months from birth to 2 years of age . Cytokine analyses of responses to housedust-mite allergen used ELISA and reverse-transcriptase PCR . We also measured responses to Fel d1 ( cat allergen ) and tetanus toxoid . FINDINGS Sample s from 18 atopic and 13 non-atopic infants showed low-level Th2-skewed allergen-specific responses at birth , with little accompanying specific interferon-gamma production . Neonatal Th2 responses were lower in the atopic group than in the non-atopic group ; the differences were significant for interleukin-4 ( mRNA : beta-actin ratio 0.48 [ SE 0.15 ] vs 0.15 [ 0.06 ] , p=0.049 ) , interleukin-6 ( 4750 [ 48 ] vs 1352 [ 51 ] pg/mL culture fluid , p=0.003 ) , interleukin-10 ( 1162 [ 228 ] vs 485 [ 89 ] , p=0.015 ) , and interleukin-13 ( 7.1 [ 0.9 ] vs 0.9 [ 0.3 ] , p=0.008 ) . There was rapid suppression of Th2 responses during the first year of life in non-atopic children , but there was consolidation of responses in atopic children , associated with defective neonatal interferon-gamma production . INTERPRETATION The continuation of fetal allergen-specific Th2 responses during infancy is a defining feature of the inductive phase of atopic disease , and is associated with decreased capacity for production of the Th1 cytokine interferon y by atopic neonates . These findings provide a plausible mechanism for persistence of the fetal Th2 responses during early childhood in atopic individuals and subsequent expression of disease",
"Over the last two decades the incidence of allergic diseases has increased in industrialized countries , and consequently new approaches have to be explored",
"Patient education has been regarded as having a key role in the self-management of atopic eczema . However , the relationship between the educational interventions and clinical outcomes including severity of eczema , quality of life , and family impact has not been rigorously examined . The purpose of this longitudinal r and omized controlled study was to evaluate the impact of an intensive education program with a focus on dermatology and immunology design ed for parents and children diagnosed with atopic eczema . The intention of this study was not to change treatment regimes prescribed by the patient 's physician . The Scoring Atopic Dermatitis rating system was used for assessment of disease impact , and the impact on quality of life was quantified by using the Children 's Dermatology Life Quality Index , Infants ' Dermatology Quality of Life Index , and Dermatitis Family Impact . A total of 61 pediatric patients ( 0 - 16 years ) diagnosed with atopic eczema from the metropolitan area of Adelaide were r and omized to either the control or intervention group . Results of the study showed that the intervention group had a significant improvement in the scoring atopic dermatitis measure when compared to the control group at week 4 and week 12 . Quality of life measures did not significantly improve with decreased severity of eczema except in the group of children aged 5 - 16 years which , despite small numbers , showed a significant improvement in quality of life scores . These findings suggest that education provides an important role in decreasing the severity of eczema",
" Oral Lactobacillus rhamnosus GG ingestion for 5 days to 4 weeks has been shown to alleviate clinical symptoms of gastrointestinal inflammation and atopic dermatitis",
"BACKGROUND The role of probiotics in prevention of allergic disease is still not clearly established , although early reports suggested Lactobacillus GG halved the risk of eczema at 2 years . OBJECTIVE To determine whether probiotic supplementation in early life could prevent development of eczema and atopy at 2 years . METHODS Double-blind , r and omized placebo-controlled trial of infants at risk of allergic disease . Pregnant women were r and omized to take Lactobacillus rhamnosus HN001 ( L rhamnosus ) , Bifidobacterium animalis subsp lactis strain HN019 or placebo daily from 35 weeks gestation until 6 months if breast-feeding , and their infants were r and omized to receive the same treatment from birth to 2 years ( n = 474 ) . The infant 's cumulative prevalence of eczema and point prevalence of atopy , using skin prick tests to common allergens , was assessed at 2 years . RESULTS Infants receiving L rhamnosus had a significantly ( P = .01 ) reduced risk of eczema ( hazard ratio [ HR ] , 0.51 ; 95 % CI , 0.30 - 0.85 ) compared with placebo , but this was not the case for B animalis subsp lactis ( HR , 0.90 ; 95 % CI , 0.58 - 1.41 ) . There was no significant effect of L rhamnosus ( HR , 0.74 ; 95 % CI , 0.46 - 1.18 ) or B animalis subsp lactis ( HR , 0.82 ; 95 % CI , 0.52 - 1.28 ) on atopy . L rhamnosus ( 71.5 % ) was more likely than B animalis subsp lactis ( 22.6 % ) to be present in the feces at 3 months , although detection rates were similar by 24 months . CONCLUSION We found that supplementation with L rhamnosus , but not B animalis subsp lactis , substantially reduced the cumulative prevalence of eczema , but not atopy , by 2 years . Underst and ing how Lactobacilli act to prevent eczema requires further investigation",
"BACKGROUND Allergic diseases have been linked to abnormal patterns of immune development , and this has stimulated efforts to define the precise patterns of cytokine dysregulation that are associated with specific atopic phenotypes . OBJECTIVE Cytokine-response profiles were prospect ively analyzed over the first year of life and compared with the clinical and immunologic expressions of atopy . METHODS Umbilical cord and 1-year P BMC s were obtained from 285 subjects from allergic families . PHA-stimulated cytokine-response profiles ( IL-5 , IL-10 , IL-13 , and IFN-gamma ) were compared with blood eosinophil counts and total and specific IgE levels ( dust mites , cat , egg , Alternaria species , peanut , milk , and dog ) at age 1 year and at the development of atopic dermatitis and food allergy . RESULTS For the cohort as a whole , cytokine responses did not evolve according to a strict TH1 or TH2 polarization pattern . PHA-stimulated cord blood cells secreted low levels of IL-5 ( 2.1 pg/mL ) , moderate levels of IFN-gamma ( 57.4 pg/mL ) , and greater amounts of IL-13 ( 281.8 pg/mL ) . From birth to 1 year , IL-5 responses dramatically increased , whereas IL-13 and IFN-gamma responses significantly decreased . Reduced cord blood secretion of IL-10 and IFN-gamma was associated with subsequent sensitization to egg . In addition , there was evidence of TH2 polarization ( increased IL-5 and IL-13 levels ) associated with blood eosinophilia and increased total IgE levels by age 1 year . CONCLUSION These findings demonstrate that cytokine responses change markedly during the first year of life and provide further evidence of a close relationship between TH2 skewing of immune responses and the incidence of atopic manifestations in children"
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BACKGROUND It has been suggested that vitamin D status or supplementation is important for maintaining or improving muscle strength and mobility in older adults . The study results , however , do not provide consistent results . We therefore aim ed to summarise the available evidence systematic ally , including only studies conducted in community-dwelling older persons . METHODS A systematic search of the literature was performed in April of 2016 . The systematic review includes studies that used vitamin D with or without calcium supplementation as the exposure variable and various measurements of muscle strength and mobility . The meta- analysis was limited to studies using h and grip strength ( HGS ) and timed-up- and -go test as the outcome variables . RESULTS A total of 15 studies out of 2408 articles from the literature search were included in the systematic review , providing 2866 participants above the age of 65 years . In the majority of studies , no improvement in muscle strength and mobility was observed after administration of vitamin D with or without calcium supplements . In the meta- analysis , we observed a nonsignificant change in HGS [ + 0.2 kg ( 95 % confidence interval = -0.25 to 0.7 kg ; seven studies ) ] and a small , significant increase in the timed-up- and -go test [ 0.3 s ( 95 % confidence interval = 0.1 to 0.5 s ; five studies ) ] after vitamin D supplementation . The meta-analyses showed a high degree of heterogeneity between the studies . CONCLUSIONS In conclusion , we observed no improvement in muscle strength after the administration of vitamin D with or without calcium supplements . We did find a small but significant deterioration of mobility . However , this is based on a limited number of studies and participants
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"An unexplained loss of muscle strength occurs with aging . Vitamin D deficiency can cause myopathy and administration of 1,25-dihydroxyvitamin D3 [ 1,25-(OH2)D3 ] to persons with low serum concentrations can improve strength . To test the hypothesis that the weakness associated with aging is in part due to inadequate serum concentrations of [ 1,25-(OH2)D3 ] , we conducted a r and omized , controlled , double blinded trial in 98 men and women volunteers over 69 yr old . Treatment consisted of 0.25 micrograms 1,25-(OH)2D3 , orally , twice per day or identical placebo for 6 months . Leg muscle strength of the quadriceps was measured with an isokinetic dynamometer . There was no difference between the two groups at 1 week , 1 month , or 6 months of treatment in any of the measures of muscle strength . We conclude that oral administration of 0.5 micrograms 1,25-(OH)2D3/day does not improve muscle strength in older persons . Further research is needed to determine the etiology of the decline in muscle strength associated with aging",
"Summary On September 29 , 2011 , acknowledged experts in the field of vitamin D , mainly European , were brought together in order to discuss the recent scientific advances in relation to vitamin D : the current requirements and associations with various health outcomes . In this article , the discussion s result ing from the meeting are summarized . Introduction Several groups at risk for developing vitamin D insufficiency have been identified . Accordingly , review s indicate that a significant percentage of the population worldwide have serum 25-hydroxyvitamin D levels below 50 nmol/l . In addition to the role of vitamin D in bone health , recent studies suggest that it may play a pivotal role in other systems , e.g. , the cardiovascular system , pancreas , muscle , immune system and brain . Most evidence , however , is obtained from observational studies and yet inconclusive . Methods To exchange and broaden knowledge on the requirements for vitamin D and its effect on various health outcomes , a workshop entitled “ Vitamin D Expert Meeting : Do we get enough ? ” , was organized . Results Despite low vitamin D levels worldwide , consensus on the definition of deficiency is not yet reached . In order to define cut-off points for vitamin D whilst taking into account extraskeletal health effects , r and omized controlled trials in these fields are warranted . The experts do emphasize that there is evidence to suggest an important role for vitamin D in the maintenance of optimal bone health at all ages and that vitamin D supplementation , in most studies co-administered with calcium , reduces fracture risk in the senior population . Conclusion To reach a serum 25-hydroxyvitamin D level of 50 nmol/l older adults aged ≥65 years are therefore recommended to meet a mean daily vitamin D intake of 20 μg ( 800 IU ) , which is best achieved with a supplement",
"CONTEXT Observational studies show an association between low vitamin D status assessed by circulating 25-hydroxyvitamin D and cardiovascular events and mortality . Data from r and omized controlled trials are limited . OBJECTIVE The aim of this study was to test whether daily doses of vitamin D(3 ) at 400 or 1000 IU/d for 1 yr affected conventional markers of cardiovascular disease ( CVD ) risk . DESIGN We conducted a parallel-group , double-blind , placebo-controlled r and omized controlled trial . R and omization was computer generated . Participants and study investigators were blinded to intervention groupings throughout the trial . SETTING The study was conducted at the Clinical Research Facility , University of Aberdeen , United Kingdom . PARTICIPANTS A total of 305 healthy postmenopausal women aged 60 - 70 yr were recruited for the study . INTERVENTION Each woman received a daily capsule of 400 or 1000 IU vitamin D(3 ) or placebo r and omly allocated . MAIN OUTCOME MEASURES Primary outcomes were serum lipid profile [ total , high-density lipoprotein , and low-density lipoprotein cholesterol ; triglycerides ; and apolipoproteins A-1 and B100 ] , insulin resistance ( homeostatic model assessment ) , inflammatory biomarkers ( high-sensitivity C-reactive protein , IL-6 , soluble intracellular adhesion molecule-1 ) , and blood pressure . RESULTS A total of 265 ( 87 % ) participants completed all study visits . Small differences between groups for serum apolipoprotein B100 change [ repeated measures ANOVA , P=0.04 ; mean ( sd ) , -1.0 ( 10.0 ) mg/dl ( 400 IU ) ; -1.0 ( 10.0 ) mg/dl ( 1000 IU ) ; and + 0.02 ( 10.0 ) mg/dl ( placebo ) ] were not considered clinical ly significant . Other systemic markers for CVD risk remained unchanged . There was significant seasonal variation in systolic and diastolic blood pressure independent of vitamin D dose ( P ( sd ) reduction in systolic blood pressure from winter to summer was -6.6 ( 10.8 ) mm Hg . CONCLUSIONS Improving vitamin D status through dietary supplementation is unlikely to reduce CVD risk factors . Confounding of seasonality should be recognized and addressed in future studies of vitamin",
"INTRODUCTION Muscle morphology and architecture changes in response to 6 weeks of progressive resistance training were examined in healthy older adults . METHODS In this r and omized , controlled design , muscle strength , quality , and architecture were evaluated with knee extension , DEXA , and ultrasound , respectively , in 25 older adults . RESULTS Resistance training result ed in significant increases in strength and muscle quality of 32 % and 31 % , respectively . Cross-sectional area of the vastus lateralis increased by 7.4 % ( p ≤ 0.05 ) . Physiological cross-sectional area ( PCSA ) of the thigh , a composite measure of muscle architecture , was related significantly to strength ( r = 0.57 ; p ≤ 0.01 ) and demonstrated a significant interaction after training ( p ≤ 0.05 ) . Change in PCSA of the vastus lateralis was associated with change in strength independent of any other measure . CONCLUSIONS Six weeks of resistance training was effective at increasing strength , muscle quality , and muscle morphology in older adult men and women",
"Aims : To investigate the effects of a 6-month supplementation with calcium and cholecalciferol on biochemical parameters and muscle strength of institutionalized elderly . Methods : This prospect i ve , double-blind , placebo-controlled , r and omized trial included Brazilian institutionalized people ≥60 years of age receiving a 6-month supplementation ( December to May ) of daily calcium plus monthly placebo ( calcium/placebo group ) or daily calcium plus oral cholecalciferol ( 150,000 IU once a month during the first 2 months , followed by 90,000 IU once a month for the last 4 months ; calcium/vitamin D group ) . Fasting blood sample s for 25(OH)D , PTH and calcium determination were collected ( n = 56 ) and muscle tests were performed ( n = 46 ) to measure the strength of hip flexors ( SHF ) and knee extensors ( SKE ) before ( baseline ) and after the 6-month intervention ( 6 months ) . Results : Due to seasonal variations , serum 25(OH)D significantly enhanced in both groups after treatment , but the calcium/vitamin D group had significantly higher 25 (OH)D levels than the calcium/placebo group ( 84 vs. 33 % , respectively ; p of hypercalcemia were observed . While the calcium/placebo group showed no improvement in SHF and SKE at 6 months ( p = 0.93 and p = 0.61 , respectively ) , SHF was increased in the calcium/vitamin D group by 16.4 % ( p = 0.0001 ) and SKE by 24.6 % ( p = 0.0007 ) . Conclusions : The suggested cholecalciferol supplementation was safe and efficient in enhancing 25(OH)D levels and lower limb muscle strength in the elderly , in the absence of any regular physical exercise practice",
"The aim was to assess the effects of resistance training and vitamin D supplementation on physical performance of healthy elderly subjects . Ninety-six subjects , aged 70 years or more with 25 OH vitamin D levels of 16 ng/ml or less , were r and omized to a resistance training or control group . Trained and control groups were further r and omized to receive in a double blind fashion , vitamin D 400 IU plus 800 mg of calcium per day or calcium alone . Subjects were followed for nine months . Serum 25 OH vitamin D increased from 12.4+/-2.2 to 25.8+/-6.5 ng/ml among subjects supplemented with vitamin D. Trained subjects had significant improvements in quadriceps muscle strength , the short physical performance test and timed up and go . The latter improved more in trained subjects supplemented with vitamin D. At the end of the follow up , gait speed was higher among subjects supplemented with vitamin ( whether trained or not ) than in non-supplemented subjects ( 838+/-147 and 768+/-127 m/12 min , respectively , p=0.02 ) . Romberg ratio was lower among supplemented controls than non-supplemented trained subjects ( 128+/-40 % and 144+/-37 % , respectively , p=0.05 ) . In conclusion , vitamin D supplementation improved gait speed and body sway , and training improved muscle strength",
"Abstract Aim : To observe the efficacy and safety of Rocaltrol ( calcitriol ) and /or Caltrate D ( calicum carbonate plus vitamin D ) in elderly Chinese women with osteopenia or osteoporosis . Methods : One hundred fifty Chinese women aged over 65 years with osteopenia or osteoporosis from three centers were r and omly divided into two groups . Seventy-six participants received Caltrate D as one pill daily ; the other 74 participants received 0.25 μg Caltrate D plus Rocaltrol daily . The changes in bone mineral density ( BMD ) served as primary end-points . Height changes , the presence of new vertebral fractures , muscle strength and balance were evaluated . Results : The following are the mean percentage changes ( and SD ) in BMD over 12 months : at L2-L4 , 0.83±3.88 in the Caltrate D group and 2.84±4.04 in the Rocaltrol+Caltrate D group ( P=0.003 , by ANCOVA ) ; at the femoral neck , 0.04±3.94 in the Caltrate D group and 2.01±5.45 in the Rocaltrol+Caltrate D group ( P=0.085 , by ANCOVA ) ; and in the trochanter , 1.59±4.57 in the Caltrate D group and 3.76±6.25 in the Rocaltrol+Caltrate D group ( P=0.053 , by ANCOVA ) . The st and and maximal forward reach test ( SMFRT ) was significantly enhanced in both groups during the 12 months of treatment , but no significant differences were found between these two groups . No severe adverse event related to these medications occurred throughout the study . Conclusion : Treatment with Rocaltrol plus Caltrate D or Caltrate D for 12 months in elderly Chinese postmenopausal women effectively increased BMD at the lumbar spine . Rocaltrol plus Caltrate D was more effective at the lumbar spine than Caltrate D alone ",
"Background Calcium ( Ca ) is an essential nutrient for the human body . Despite lively research , there is uncertainty about Ca requirements in terms of desirable health outcomes including an upper intake level above which the potential for harm increases . Objectives The aim was to conduct a review to up date requirements and desirable or harmful health effects of Ca on the current scientific evidence . Methods We search ed Medline and Swemed from January 2000 to December 2011 and included all systematic review s that reported Ca supplementation or usual Ca intake on health outcomes . Meta-analyses , r and omized clinical trials and cohort studies were included in the second search between May 2009 and March 2011 and an additional search covering studies till the end of 2011 . This review concentrated on studies reporting independent effects of Ca , although a few recent trials report sole effects of Ca on health outcomes , most trials use Ca in combination with vitamin D vs. placebo . Results In total , we review ed 38 studies addressing the effects of Ca on bone , pregnancy-related outcomes , cancers , cardiovascular outcomes , obesity , and mortality . There was a lot of heterogeneity in the study protocol s , which made it difficult to draw any strong conclusions . According to the literature , high Ca intake seems to have a small positive effect on bone mineral content ( BMC ) or bone mineral density ( BMD ) in children and postmenopausal women . We did not find any consistent evidence on the effects of Ca on bone health in premenopausal women or men . Also , the evidence that Ca supplementation reduces fracture incidence is scarce and inconsistent . Maternal diet may influence the peak bone mass of offspring but more studies are required . There was no overall effect of Ca intake on cancers . Ca was associated with a decreased risk of breast cancer and a slightly increased risk of prostate cancer in two of the three studies . No associations were found with other cancers . We found no consistent association between cardiovascular outcomes and Ca intake except for blood pressure . A small decrease of 2–4 mmHg in systolic blood pressure was found in pregnant and in hypertensive subjects with Ca supplementation . Review ed studies did not show consistent evidence relating Ca intake to either mortality or obesity . Conclusion Based on this evidence , there is no need to change the Nordic recommendations for Ca intake . However , due to heterogeneity in the studies it is difficult to interpret the results and provide single summary statement",
"The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . 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 .",
"CONTEXT Improving vitamin D status may be an important modifiable risk factor to reduce falls and fractures ; however , adherence to daily supplementation is typically poor . OBJECTIVE To determine whether a single annual dose of 500,000 IU of cholecalciferol administered orally to older women in autumn or winter would improve adherence and reduce the risk of falls and fracture . DESIGN , SETTING , AND PARTICIPANTS A double-blind , placebo-controlled trial of 2256 community-dwelling women , aged 70 years or older , considered to be at high risk of fracture were recruited from June 2003 to June 2005 and were r and omly assigned to receive cholecalciferol or placebo each autumn to winter for 3 to 5 years . The study concluded in 2008 . INTERVENTION 500,000 IU of cholecalciferol or placebo . MAIN OUTCOME MEASURES Falls and fractures were ascertained using monthly calendars ; details were confirmed by telephone interview . Fractures were radiologically confirmed . In a sub study , 137 r and omly selected participants underwent serial blood sampling for 25-hydroxycholecalciferol and parathyroid hormone levels . RESULTS Women in the cholecalciferol ( vitamin D ) group had 171 fractures vs 135 in the placebo group ; 837 women in the vitamin D group fell 2892 times ( rate , 83.4 per 100 person-years ) while 769 women in the placebo group fell 2512 times ( rate , 72.7 per 100 person-years ; incidence rate ratio [ RR ] , 1.15 ; 95 % confidence interval [ CI ] , 1.02 - 1.30 ; P = .03 ) . The incidence RR for fracture in the vitamin D group was 1.26 ( 95 % CI , 1.00 - 1.59 ; P = .047 ) vs the placebo group ( rates per 100 person-years , 4.9 vitamin D vs 3.9 placebo ) . A temporal pattern was observed in a post hoc analysis of falls . The incidence RR of falling in the vitamin D group vs the placebo group was 1.31 in the first 3 months after dosing and 1.13 during the following 9 months ( test for homogeneity ; P = .02 ) . In the sub study , the median baseline serum 25-hydroxycholecalciferol was 49 nmol/L. Less than 3 % of the sub study participants had 25-hydroxycholecalciferol levels lower than 25 nmol/L. In the vitamin D group , 25-hydroxycholecalciferol levels increased at 1 month after dosing to approximately 120 nmol/L , were approximately 90 nmol/L at 3 months , and remained higher than the placebo group 12 months after dosing . CONCLUSION Among older community-dwelling women , annual oral administration of high-dose cholecalciferol result ed in an increased risk of falls and fractures . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12605000658617 ; is rct n.org Identifier : IS RCT N83409867",
"OBJECTIVE The purpose of this study was to evaluate the efficacy of alfacalcidol and calcium on the improvement of muscle strength in ambulatory elderly Thai women in age group of 65 or more who have hypovitaminosis D. MATERIAL AND METHOD Seventy-two postmenopausal women age 65 years or more were enrolled to this study . Blood was collected from all participants for measured of 25(OH)D3 , intact PTH and vitamin D receptor ( VDR ) genotypes . After blood collection , the quadriceps muscle strength was measured using the isokinetic dynamometer device . There were 42 subjects who satisfy the eligible criteria and agreed to participate in the experimental r and omized controlled study . These subjects were r and omized into two groups , one received calcium 1500 g/day combined with alfacalcidol 0.5 mg/day . Another group received calcium 1500 g/day with placebo . RESULTS After 12 weeks of intervention , 40 subjects had the second muscle strength measurement ( 2 dropped out ) . By ANCOVA analysis , there were significant improvement of muscle strength in the group that received alfacalcidol compared to placebo in both 30 degrees/sec ( 20.28 vs.16.29 , p = 0.025 ) and 60 degrees/sec ( 20.32 vs. 15.05 , p = 0.002 ) angular velocities . CONCLUSION Daily doses of 0.5 mg alfacalcidol with calcium effectively improved muscle strength in elderly Thai women who had low level of 25(OH)D3 compared to calcium alone",
"Background Sarcopenia is strongly associated with an inadequate intake of dietary protein . Dietary protein supplementation boosts muscle-protein synthesis and increases muscle mass in the elderly . This study tested whether adding a protein-rich food , ricotta cheese , to the habitual diet increased total appendicular skeletal muscle mass and strength in elderly people . Methods Participants ( n = 40 ) , were sarcopenic elderly men and women over 60 years of age . Two comparison groups were formed at r and om and followed for 3 months : the intervention group received 210 g/day of ricotta cheese plus the habitual diet , while the control group followed the habitual diet with no additional intervention . Total appendicular skeletal muscle ( TASM ) was assessed by dual-energy X-ray absorptiometry , while strength was measured using a h and held dynamometer at baseline and after the intervention period . The primary outcomes were the percentage of relative change in TASM and strength . Results The percentage of relative change in TASM was not significant between the groups after the intervention period . Muscle strength improved in the intervention group , but showed only a tendency towards significance ( P = 0.06 ) . Secondary analysis showed that the men in the intervention group gained 270 g in TASM compared to those in the control group , and improved their fasting insulin levels ( P = 0.05 ) , muscle strength , lean body mass in the arms , and body weight variables . Conclusion The results of this study indicate that a nutritional intervention using a high- quality protein food , specifically ricotta cheese , in order to increase the amount of protein intake might not be regarded as fully promising in elderly men and women with sarcopenia . However , the gender effects on muscle strength , lean tissue in the arms , homeostatic assessment of insulin resistance , and body weight detected in this study suggest that additional research is needed on elderly male subjects with sarcopenia",
"Summary Daily dosing with vitamin D often fails to achieve optimal outcomes , and it is uncertain what the target level of 25-hydroxyvitamin D should be . This study found that large loading doses of vitamin D3 rapidly and safely normalize 25OHD levels , and that monthly dosing is similarly effective after 3–5 months . With baseline 25OHD > 50 nmol/L , vitamin D supplementation does not reduce PTH levels . Introduction There is concern that vitamin D supplementation doses are frequently inadequate , and that compliance with daily medication is likely to be suboptimal . Methods This r and omized double-blind trial compares responses to three high-dose vitamin D3 regimens and estimates optimal 25-hydroxyvitamin D ( 25OHD ) levels , from changes in parathyroid hormone ( PTH ) , and procollagen type I amino-terminal propeptide ( P1NP ) in relation to baseline 25OHD . Sixty-three elderly participants were r and omized to three regimens of vitamin D supplementation : a 500,000-IU loading dose ; the loading dose plus 50,000 IU/month ; or 50,000 IU/month . Results The Loading and Loading + Monthly groups showed increases in 25OHD of 58 ± 28 nmol/L from baseline to 1 month . Thereafter , levels gradually declined to plateaus of 69 ± 5 nmol/L and 91 ± 4 nmol/l , respectively . In the Monthly group , 25OHD reached a plateau of ~80 ± 20 nmol/L at 3–5 months . There were no changes in serum calcium concentrations . PTH and P1NP were only suppressed by vitamin D treatment in those with baseline 25OHD levels of vitamin D3 rapidly and safely normalize 25OHD levels in the frail elderly . Monthly dosing is similarly effective and safe , but takes 3–5 months for plateau 25OHD levels to be reached",
"Objective The aim of this study was to investigate the additive effect of the active form of vitamin D3 on the gain in back extensor strength through a back extensor exercise . Design A total of 107 postmenopausal women with osteoporosis were r and omly divided into two groups : the D3 group and the control group . Both groups were treated with calcium and alendronate and undertook the back extensor exercise . Alfacalcidol was prescribed only to the D3 group . Results There was no significant difference in the demographic data between the two groups . Ninety-four participants who completed a 4-mo intervention were subjected to per- protocol analysis . There was no significant difference in the improvement in back extensor strength between two the groups ( P = 0.349 ) . All subjects were further categorized into two subgroups by age . In the older subgroup ( ≥68 yrs ) , no significant difference was found in the improvement in back extensor strength ( P = 0.316 ) . In the younger subgroup ( , the back extensor strength in the D3 group was significantly more improved than in the control group ( P = 0.034 ) . Conclusions The results of this study suggest that the administration of the active form of vitamin D3 enhances the beneficial effects of the back extensor exercise in patients younger than those in their late 60s",
"BACKGROUND vitamin D supplementation reduces the incidence of fractures in older adults . This may be partly mediated by effects of vitamin D on neuromuscular function . OBJECTIVE to determine the effects of vitamin D supplementation on aspects of neuromuscular function known to be risk factors for falls and fractures . DESIGN r and omised , double-blind , placebo-controlled study . SETTING falls clinic taking referrals from general practitioners and accident and emergency department . SUBJECTS 139 ambulatory subjects ( > /=65 years ) with a history of falls and 25-hydroxyvitamin D ( 25OHD ) INTERVENTION patients were r and omised to receive a single intramuscular injection of 600,000 i.u . ergocalciferol or placebo . OUTCOME MEASURES assessment s including biochemistry , postural sway , choice reaction time ( CRT ) , aggregate functional performance time ( AFPT ) , and quadriceps strength were carried out at baseline and 6 months post-intervention . RESULTS baseline characteristics were comparable between both groups . 25OHD in the treatment group increased significantly at 6 months . AFPT deteriorated in the control group and improved in the intervention group , representing a significant difference between groups ( + 6.6 s versus -2.0 s , t = 2.80 , P CRT ( -0.06 s versus + 0.41 s , t = -2.52 , P postural sway ( + 0.0025 versus -0.0138 , t = 2.35 , P muscle strength change between groups ( -10 N versus -2 N , t = -1.26 , ns ) . A significant correlation between change in AFPT and change in 25OHD levels was observed ( r = 0.19 , P = 0.03 ) . There was no significant difference in the number of falls ( 0.39 versus 0.24 , t = 1.08 , P = 0.28 ) or fallers ( 14 versus 11 , P = 0.52 ) between two groups . CONCLUSIONS vitamin D supplementation , in fallers with vitamin D insufficiency , has a significant beneficial effect on functional performance , reaction time and balance , but not muscle strength . This suggests that vitamin D supplementation improves neuromuscular or neuroprotective function , which may in part explain the mechanism whereby vitamin D reduces falls and fractures",
"BACKGROUND Vitamin D insufficiency , which is prevalent in older individuals , is associated with bone and muscle weakness and falls . OBJECTIVE We examined the effects of a weekly dose of 8400 IU vitamin D(3 ) on postural stability , muscle strength , and safety . DESIGN In this double-blind trial , subjects aged > or = 70 y with serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations or = 6 ng/mL were r and omly assigned to receive a weekly dose of 8400 IU vitamin D(3 ) ( n = 114 ) or a placebo ( n = 112 ) . Mediolateral body sway with eyes open ( assessed with the AccuSway(PLUS ) platform ; Advanced Medical Technology Inc , Watertown , MA ) was the primary endpoint . Secondary endpoints included the short physical performance battery ( SPPB ) and serum 25(OH)D concentrations . An analysis of covariance model was used for treatment comparisons . Safety and tolerability were monitored . RESULTS Serum 25(OH)D concentrations rose significantly ( from 13.9 to 26.2 ng/mL , P placebo . After 16 wk , neither mediolateral sway nor SPPB differed significantly between treatment groups . However , in the post hoc analysis of patients subgrouped by baseline sway ( > or = 0.46 compared with sway compared with treatment with placebo ( P = 0.047 ) in patients with elevated baseline sway but not in patients with normal baseline sway . Adverse experiences and incidences of hypercalcemia , hypercalciuria , and elevated creatinine were similar with both treatments . In patients treated with 8400 IU vitamin D(3 ) , but not in placebo-treated patients , parathyroid hormone decreased significantly . CONCLUSIONS Weekly treatment with 8400 IU vitamin D(3 ) raised 25(OH)D concentrations in elderly , vitamin D-insufficient individuals . Treatment with 8400 IU vitamin D(3 ) did not reduce mediolateral sway significantly compared with treatment with placebo in this population , although in post hoc analysis , treatment with 8400 IU vitamin D(3 ) reduced sway in the subgroup of patients who had elevated sway at baseline . Weekly treatment with 8400 IU vitamin D(3 ) was well tolerated . This trial was registered at clinical trials.gov as NCT00242476",
"Summary Vitamin D can improve muscle function and reduce falls , but whether it can strengthen neural connections within the brain and nervous system is not known . This 10-week r and omised controlled trial indicates that treatment with 2,000 IU/day vitamin D3 does not significantly alter neuroplasticity relative to placebo in older adults . Introduction The purpose of this study was to examine the effects of vitamin D supplementation on neuroplasticity , serum brain-derived neurotrophic factor ( BDNF ) and muscle strength and function in older adults . Methods This was a 10-week double-blinded , placebo-controlled r and omised trial in which 26 older adults with 25-hydroxyvitamin D [ 25OHD ] concentrations 25–60 nmol/L were r and omised to 2,000 IU/day vitamin D3 or matched placebo . Single- and paired-pulse transcranial magnetic stimulation applied over the motor cortex was used to assess changes in motor-evoked potentials ( MEPs ) and short-interval intracortical inhibition ( SICI ) , as measures of corticospinal excitability and inhibition respectively , by recording electromyography ( EMG ) responses to stimulation from the wrist extensors . Changes in muscle strength , stair climbing power , gait ( timed-up- and -go ) , dynamic balance ( four square step test ) , serum 25(OH)D and BDNF concentrations were also measured . Results After 10 weeks , mean 25(OH)D levels increased from 46 to 81 nmol/L in the vitamin D group with no change in the placebo group . The vitamin D group experienced a significant 8–11 % increase in muscle strength and a reduction in cortical excitability ( MEP amplitude ) and SICI relative to baseline ( all P vitamin D on muscle power , function or BDNF . Conclusions Daily supplementation with 2,000 IU vitamin D3 for 10 weeks had no significant effect on neuroplasticity compared to placebo , but the finding that vitamin D treatment alone was associated with a decrease in corticospinal excitability and intracortical inhibition warrants further investigation as this suggests that it may improve the efficacy of neural transmission within the corticospinal pathway",
"OBJECTIVE Vitamin D supplementation is suggested to reduce the risk of falls among ambulatory or institutionalized elderly subjects . The present study was undertaken to address the reduced risk of falls and hip fractures in patients with long-st and ing stroke by vitamin D supplementation . METHODS Ninety-six elderly women with poststroke hemiplegia were followed for two years . Patients were r and omly assigned to one of the two groups , and 48 patients received 1,000 IU ergocalciferol daily , and the remaining 48 received placebo . The number of falls per person and incidence of hip fractures were compared between the two groups . Strength and tissue ATPase of skeletal muscles on the nonparetic side were assessed before and after the study . RESULTS At baseline , serum 25-hydroxyvitamin D levels were in the deficient range ( vitamin D treatment enhanced serum 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D levels . Vitamin D treatment accounted for a 59 % reduction in falls ( 95 % CI , 28 - 81 % ; p = 0.003 ) . There were increases in the relative number and size of type II muscle fibers and improved muscle strength in the vitamin D-treated group . Hip fractures occurred in 4 of 48 placebo group and 0 in 48 vitamin D2 group during the 2-year study period ( log-rank , p = 0.049 ) . CONCLUSION Vitamin D may increase muscle strength by improving atrophy of type II muscle fibers , which may lead to decreased falls and hip fractures",
"Objective To determine if sarcopenia modulates the response to a physical activity intervention in functionally limited older adults . Design Secondary analysis of a r and omized controlled trial . Setting Three academic centers . Participants Elders aged 70 to 89 years at risk for mobility disability who underwent dualenergy x-ray absorptiometry ( DXA ) for body composition at enrollment and follow-up at twelve months ( N = 177 ) . InterventionS ubjects participated in a physical activity program ( PA ) featuring aerobic , strength , balance , and flexibility training , or a successful aging ( SA ) educational program about healthy aging . Measurements Sarcopenia as determined by measuring appendicular lean mass and adjusting for height and total body fat mass ( residuals method ) , Short Physical Performance Battery score ( SPPB ) , and gait speed determined on 400 meter course . Results At twelve months , sarcopenic and non-sarcopenic subjects in PA tended to have higher mean SPPB scores ( 8.7±0.5 and 8.7±0.2 points ) compared to sarcopenic and non-sarcopenic subjects in SA ( 8.3±0.5 and 8.4±0.2 points , p = 0.24 and 0.10 ) , although the differences were not statistically significant . At twelve months , faster mean gait speeds were observed in PA : 0.93±0.4 and 0.95±0.03 meters/second in sarcopenic and non-sarcopenic PA subjects , and 0.89±0.4 and 0.91±0.03 meters/second in sarcopenic and non-sarcopenic SA subjects ( p = 0.98 and 0.26 ) , although not statistically significant . There was no difference between the sarcopenic and non-sarcopenic groups in intervention adherence or number of adverse events . Conclusion These data suggest that older adults with sarcopenia , who represent a vulnerable segment of the elder population , are capable of improvements in physical performance after a physical activity intervention ",
"Background and aims : Insufficient vitamin D status , commonly found in older people , has been associated with muscle weakness which , in old age , impairs mobility and is a risk factor for falling . In a r and omized , double-blind placebo-controlled trial , we tested the hypothesis that vitamin D + calcium supplementation improves muscle strength and mobility , compared with calcium mono-therapy in vitamin D-insufficient female geriatric patients . Methods : Seventy female geriatric patients > 65 years of age with serum 25-hydroxyvitamin D3 ( 25OHD ) concentrations between 20 and 50 nmol/L , visiting an outpatient geriatric department , were included . Participants received either cholecalciferol 400 IU/day + calcium 500 mg/day ( D/Cal group ) or a placebo + calcium 500 mg/day ( Plac/Cal group ) for 6 months . At baseline and 6 months , muscle strength , power and functional mobility were tested . Results : At baseline , 25OHD was significantly ( p with knee extension strength ( r=0.42 ) , h and grip strength ( r=0.28 ) , leg extension power ( r=0.34 ) , Timed Get Up and Go ( r=−0.31 ) and Modified Cooper test ( r=0.44 ) . At 6 months , a significant difference in 25OHD ( 77.2 vs 41.6 nmol/L , p and 1,25OHD was found between the two groups . Significantly improving vitamin D status in the D/Cal group compared with the Plac/Cal group did not result in a significant difference in strength or functional mobility between the two groups . Conclusions : Daily 400IU vitamin D + 500 mg calcium supplementation is not enough to significantly improve strength or mobility in vitamin D-insufficient female geriatric patients",
"Daily vitamin D in addition to calcium supplementation reduces falls and fractures in older women . However , poor adherence to therapy is a common clinical problem . To examine the effects of supervised oral 3-monthly vitamin D therapy on falls , muscle strength , and mobility , we conducted a 9-month r and omized , double-blind , placebo-controlled trial in 686 community-dwelling ambulant women aged over 70 years . Participants received either oral cholecalciferol 150,000 IU every 3 months ( n = 353 ) or an identical placebo ( n = 333 ) . All participants were advised to increase dietary calcium intake . Falls data were collected 3-monthly . At baseline , 3 , 6 , and 9 months , muscle strength was measured by a h and held dynamometer and mobility by the Timed Up and Go ( TUG ) test . Serum 25 hydroxyvitamin D ( 25OHD ) was measured in a subgroup of 40 subjects . Mean age at baseline was 76.7 ± 4.1 years . The average serum 25OHD value at baseline was 65.8 ± 22.7 nmol/L. By 3 , 6 , and 9 months after supplementation , 25OHD levels of the vitamin D group were approximately 15 nmol/L higher than the placebo group . Calcium intake did not change significantly between baseline ( 864 ± 412 mg/day ) and 9 months ( 855 ± 357 mg/day ) . Faller rates in the two groups did not differ : vitamin D group , 102 of 353 ( 29 % ) ; placebo group , 89 of 333 ( 27 % ) . At 9 months , compared to placebo or baseline , muscle strength , and TUG were not altered by vitamin D. In conclusion , oral cholecalciferol 150,000 IU therapy administered 3-monthly had neither beneficial nor adverse effects on falls or physical function . These data together with previous findings confirm that intermittent large doses of vitamin D are ineffective or have a deleterious effect on falls . Thus despite adherence issues with daily vitamin D replacement , an intermittent , high-dose vitamin D regimen can not be supported as a strategy to reduce falls and fractures",
"The age-related change in hormone concentrations has been hypothesized to play a role in the loss of muscle mass and muscle strength with aging , also called sarcopenia . The aim of this prospect i ve study was to investigate whether low serum 25-hydroxyvitamin D ( 25-OHD ) and high serum PTH concentration were associated with sarcopenia . In men and women aged 65 yr and older , participants of the Longitudinal Aging Study Amsterdam , grip strength ( n = 1008 ) and appendicular skeletal muscle mass ( n = 331 , using dual-energy x-ray absorptiometry ) were measured in 1995 - 1996 and after a 3-yr follow-up . Sarcopenia was defined as the lowest sex-specific 15th percentile of the cohort , translating into a loss of grip strength greater than 40 % or a loss of muscle mass greater than 3 % . After adjustment for physical activity level , season of data collection , serum creatinine concentration , chronic disease , smoking , and body mass index , persons with low ( 25-OHD levels were 2.57 ( 95 % confidence interval 1.40 - 4.70 , based on grip strength ) and 2.14 ( 0.73 - 6.33 , based on muscle mass ) times more likely to experience sarcopenia , compared with those with high ( > 50 nmol/liter ) levels . High PTH levels ( > or=4.0 pmol/liter ) were associated with an increased risk of sarcopenia , compared with low PTH ( grip strength , odds ratio = 2.35 ( 1.05 - 5.28 ) based on muscle mass . The associations were similar in men and women . The results of this prospect i ve , population -based study show that lower 25-OHD and higher PTH levels increase the risk of sarcopenia in older men and women",
"Summary In 242 community-dwelling seniors , supplementation with either 1000 mg of calcium or 1000 mg of calcium plus vitamin D result ed in a decrease in the number of subjects with first falls of 27 % at month 12 and 39 % at month 20 . Additionally , parameters of muscle function improved significantly . Introduction The efficacy of vitamin D and calcium supplementation on risk of falling in the elderly is discussed controversially . R and omized controlled trials using falls as primary outcome are needed . We investigated long-term effects of calcium and vitamin D on falls and parameters of muscle function in community-dwelling elderly women and men . Methods Our study population consisted of 242 individuals recruited by advertisements and mailing lists ( mean [ ± SD ] age , 77 ± 4 years ) . All serum 25-hydroxyvitamin D ( 25[OH]D ) levels were below 78 nmol/l . Individuals received in a double blinded fashion either 1000 mg of calcium or 1000 mg of calcium plus 800 IU of vitamin D per day over a treatment period of 12 months , which was followed by a treatment-free but still blinded observation period of 8 months . Falls were documented using diaries . The study took place in Bad Pyrmont , Germany ( latitude 52 ° ) and Graz , Austria ( latitude 46 ° ) . Results Compared to calcium mono , supplementation with calcium plus vitamin D result ed in a significant decrease in the number of subjects with first falls of 27 % at month 12 ( RR = 0.73 ; CI = 0.54–0.96 ) and 39 % at month 20 ( RR = 0.61 ; CI = 0.34–0.76 ) . Concerning secondary endpoints , we observed significant improvements in quadriceps strength of 8 % , a decrease in body sway of 28 % , and a decrease in time needed to perform the TUG test of 11 % . Discussion Combined calcium and vitamin D supplementation proved superior to calcium alone in reducing the number of falls and improving muscle function in community-dwelling older individuals",
"OBJECTIVE The adequate dose of vitamin D supplementation for community-dwelling elderly people has not been thoroughly investigated . This study aims to determine the efficacy of a low-dose and a higher dose of vitamin D3 in maintaining 25-hydroxyvitamin D [ 25(OH)D ] levels at or above 30 ng/mL. METHODS This was a single site , double-blind , r and omized exploratory clinical trial that enrolled adults 65 years of age and older . Within strata of baseline 25(OH)D levels ( subjects were r and omized in a 1:2 ratio to receive either 400 or 2,000 IU vitamin D3 daily for 6 months . The main outcome measures were changes in serum 25(OH)D levels according to baseline 25(OH)D levels and dose of vitamin D3 . RESULTS At baseline , 41 of 105 participants ( 39 % ) had low 25(OH)D levels ( months of vitamin D3 supplementation , 21 of 32 participants ( 66 % ) receiving 400 IU and 14 of 59 participants ( 24 % ) receiving 2,000 IU of vitamin D3 still had low 25(OH)D levels . The largest increases in serum 25(OH)D levels were observed in subjects with baseline levels persons 65 years of age and older , 6-month vitamin D3 supplementation with 400 IU daily result ed in low 25(OH)D in most individuals , while 2,000 IU daily maintained 25(OH)D levels within an acceptable range in most people on this regimen",
"Summary Vitamin D may affect skeletal muscle function . In a double-blind , r and omised , placebo-controlled trial , we found that vitamin D3 supplementation ( 400 or 1,000 I.U. vs. placebo daily for 1 year with bimonthly study visits ) does not improve grip strength or reduce falls . Introduction This study aim ed to test the supplementation effects of vitamin D3 on physical function and examine associations between overweight/obesity and the biochemical response to treatment . Methods In a parallel group double-blind RCT , healthy postmenopausal women from North East Scotl and ( latitude—57 ° N ) aged 60–70 years ( body mass index ( BMI ) , 18–45 kg/m2 ) were assigned ( computer r and omisation ) to daily vitamin D3 ( 400 I.U. ( n = 102)/1,000 I.U. ( n = 101 ) ) or matching placebo ( n = 102 ) ( 97 , 96 and 100 participants analysed for outcomes , respectively ) from identical coded containers for 1 year . Grip strength ( primary outcome ) , falls , diet , physical activity and ultraviolet B radiation exposure were measured bimonthly , as were serum 25(OH)D , adjusted calcium ( ACa ) and phosphate . Fat/lean mass ( dual energy X-ray absorptiometry ) , anthropometry , 1,25-dihydroxyvitamin D and parathyroid hormone were measured at baseline and 12 months . Participants and research ers were blinded throughout intervention and analysis . Results Treatment had no effect on grip strength ( mean change (SD)/year = −0.5 ( 2.5 ) , −0.9 ( 2.7 ) and −0.4 ( 3.3 ) kg force for 400/1,000 I.U. vitamin D3 and placebo groups , respectively ( P = .10 , ANOVA ) ) or falls ( P = .65 , chi-squared test ) . Biochemical responses were similar across BMI categories ( in serum ACa in overweight compared to non-overweight participants ( P = .01 , ANOVA ; 1,000 I.U. group ) . In the placebo group , 25(OH)D peak concentration change ( winter to summer ) was negatively associated with weight ( r = −.268 ) , BMI ( r = −.198 ) , total ( r = −.278 ) and trunk fat mass ( r = −.251 ) , with total and trunk fat mass predictive of winter to summer 25(OH)D change ( P = .01/.004 respectively , linear regression ) . Conclusion We found no evidence of an improvement in physical function following vitamin D3 supplementation for 1 year",
"There is an increase in the incidence of falls with aging and about 10 % of falls lead to fractures . Nearly all hip fractures are due to falls and hip fractures are the most severe of the osteoporotic fractures because they lead to a 20 % mortality rate and a loss of independent living in 50 % of cases . Although there are multiple factors associated with falls , our interest is the role that vitamin D metabolism plays in the pathogenesis of falls . Recent clinical trials show that both vitamin D and the metabolite calcitriol reduce the number of falls by 30 - 40 % in elderly subjects . This should also reduce the number of fractures . In European studies , the decrease in falls could be attributed to an improvement in the muscle weakness that often accompanies vitamin D deficiency . However , in the studies using calcitriol there was no vitamin D deficiency , so the mechanism of its efficacy is less clear . It could be due to increased muscle strength , an improvement in the neurological control of balance or both . Underst and ing these mechanisms would allow us to search for analogs of vitamin D that act more selectively on muscle and on the central nervous system",
"OBJECTIVES To study the effects of vitamin D supplementation in healthier population s of men . DESIGN : R and omized , controlled trial . SETTING General clinical research center . PARTICIPANTS Sixty-five healthy , community-dwelling men ( mean age+/-st and ard deviation=76+/-4 , range 65 - 87 ) . INTERVENTION Cholecalciferol ( 1,000 IU/d ) or placebo supplementation for 6 months ; all received 500 mg supplemental calcium . MEASUREMENTS Upper and lower extremity muscle strength and power , physical performance and activity , health perception , calcium and vitamin D intake , and biochemical assessment , including 25-hydroxyvitamin D ( 25OHD ) , parathyroid hormone ( PTH ) , and ionized calcium levels . RESULTS The levels of 25OHD increased and PTH decreased in the cholecalciferol group , whereas there were no significant changes in the control group ( P Baseline 25OHD levels correlated with baseline single-leg stance time and physical activity score . Baseline PTH levels correlated with baseline 8-foot walk time and physical activity score . No significant difference in strength , power , physical performance , or health perception was found between groups . CONCLUSION The 25OHD or PTH levels correlated with physical activity and physical performance in older , community-dwelling men with normal 25OHD status . Vitamin D supplementation increased 25OHD levels and decreased PTH levels but did not increase muscle strength or improve physical performance or health perception in this group of healthy , older men . Further investigations of the effects of vitamin D supplementation should focus on individuals with low levels of vitamin",
"There is an ongoing debate over the role of serum 25(OH ) vitamin D [ 25(OH)D ] levels in maintaining or improving physical performance and muscle strength . Much of the controversy is because of the variability between studies in participants ' characteristics , baseline serum 25(OH)D levels , and baseline physical functioning . The aim of this ancillary study conducted within a r and omized controlled clinical trial was to investigate whether supplementation with 400 or 2000 IU vitamin D3 daily for 6 months would improve measures of physical performance and muscle strength in a community-dwelling elderly population aged 65 to 95 years . Those with the slowest gait speed improved their ability to do chair-st and tests after vitamin D supplementation . This finding remained significant after controlling for potential confounding variables . There was also an inverse correlation between serum 25(OH)D levels and fat mass index ( FMI ) among women , suggesting that higher supplementation with vitamin D is needed as weight increases . The results of this study suggest that supplementation with vitamin D may be most beneficial in older population s who have low baseline physical functioning",
"BACKGROUND Older adults may be more prone to developing vitamin D deficiency than younger adults . Dietary requirements for vitamin D in older adults are based on limited evidence . OBJECTIVE The objective was to establish the dietary intake of vitamin D required to maintain serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations above various cutoffs between 25 and 80 nmol/L during wintertime , which accounted for the effect of summer sunshine exposure and diet . DESIGN A r and omized , placebo-controlled , double-blind , 22-wk intervention was conducted in men and women aged > /=64 y ( n = 225 ) at supplemental levels of 0 , 5 , 10 , and 15 microg vitamin D(3)/d from October 2007 to March 2008 . RESULTS Clear dose-related increments ( P serum 25(OH)D were observed with increasing supplemental vitamin D(3 ) intakes . The slope of the relation between total vitamin D intake and serum 25(OH)D was 1.97 nmol . L(-1 ) . microg intake(-1 ) . The vitamin D intake that maintained serum 25(OH)D concentrations > 25 nmol/L in 97.5 % of the sample was 8.6 microg/d . Intakes were 7.9 and 11.4 microg/d in those who reported a minimum of 15 min daily summer sunshine exposure or less , respectively . The intakes required to maintain serum 25(OH)D concentrations of > 37.5 , > 50 , and > 80 nmol/L in 97.5 % of the sample were 17.2 , 24.7 , and 38.7 microg/d , respectively . CONCLUSION To ensure that the vitamin D requirement is met by the vast majority ( > 97.5 % ) of adults aged > /=64 y during winter , between 7.9 and 42.8 microg vitamin D/d is required , depending on summer sun exposure and the threshold of adequacy of 25(OH)D. This trial was registered at http://www.controlled-trials.com/IS RCT N20236112 as IS RCT N registration no. IS RCT N20236112",
"OBJECTIVES To determine the effectiveness of vitamin D and home-based quadriceps resistance exercise on reducing falls and improving the physical health of frail older people after hospital discharge . DESIGN Multicenter , r and omized , controlled trial with a factorial design . SETTING Five hospitals in Auckl and , New Zeal and , and Sydney , Australia . PARTICIPANTS Two hundred forty-three frail older people . INTERVENTIONS Patients were r and omized to receive a single dose of vitamin D ( calciferol , 300,000 IU ) or placebo tablets and 10 weeks of high-intensity home-based quadriceps resistance exercise or frequency-matched visits . MEASUREMENTS The primary endpoints were physical health according to the short-form health survey at 3 months and falls over 6 months . Physical performance and self-rated function were secondary endpoints . Assessment s took place in the participants ' homes at 3 and 6 months after r and omization and were performed by blinded assessors . RESULTS There was no effect of either intervention on physical health or falls , but patients in the exercise group were at increased risk of musculoskeletal injury ( risk ratio = 3.6 , 95 % confidence interval = 1.5 - 8.0 ) . Vitamin D supplementation did not improve physical performance , even in those who were vitamin D deficient ( vitamin D supplementation nor a home-based program of high-intensity quadriceps resistance exercise improved rehabilitation outcomes in frail older people after hospitalization . There was no effect of vitamin D on physical performance , and the exercises increased the risk of musculoskeletal injury . These findings do not support the routine use of these interventions at these dosages in the rehabilitation of frail older people",
"OBJECTIVES To evaluate the effects of vitamin D treatment on muscle strength and mobility in older women with vitamin D insufficiency . DESIGN One-year population -based , double-blind , r and omized , controlled trial . SETTING Perth , Australia ( latitude 32 ° S ) . PARTICIPANTS Three hundred two community-dwelling ambulant elderly women aged 70 to 90 with a serum 25-hydroxyvitamin D ( 25(OH)D ) concentration less than 24 ng/mL. INTERVENTION Vitamin D(2 ) 1,000 IU/d or identical placebo ; calcium citrate ( 1 g calcium/d ) in both groups . MEASUREMENTS Lower limb muscle strength and mobility as assessed using the Timed Up and Go Test ( TUAG ) . RESULTS At baseline , mean ± st and ard deviation serum 25(OH)D was 17.7 ± 4.2 ng/mL ; this increased to 24.0 ± 5.6 ng/mL in the vitamin D group after 1 year but remained the same in the placebo group . For hip extensor and adductor strength and TUAG , but not for other muscle groups , a significant interaction between treatment group and baseline values was noted . In those with baseline values in the lowest tertile , vitamin D improved muscle strength and TUAG more than calcium alone ( mean ( st and ard error ) : hip extensors 22.6 % ( 9.5 % ) ; hip adductors 13.5 % ( 6.7 % ) , TUAG 17.5 % ( 7.6 % ) , P .05 ) . Baseline 25(OH)D levels did not influence patient response to supplementation . CONCLUSION Vitamin D therapy was observed to increase muscle function in those who were the weakest and slowest at baseline . Vitamin D should be given to people with insufficiency or deficiency to improve muscle strength and mobility",
"OBJECTIVES The Women 's Health Initiative ( WHI ) r and omized trial of calcium/vitamin D supplementation found reduced bone loss with active treatment compared to placebo . Now we examine whether the treatment affected self-reported physical functioning and objective measures of physical functioning . DESIGN A r and omized , double-blind , placebo-controlled trial of 1,000 mg calcium carbonate plus 400 IU vitamin D(3 ) per day or matching placebo pills . SUBJECTS/ SETTING The study included 33,067 women ( 50 to 79 years old ) at 40 US study centers . MAIN OUTCOME MEASURES Physical functioning was assessed by question naire at enrollment in WHI , 1 year prior to calcium/vitamin D trial r and omization and at study close-out ( average follow-up 7.1 years ) . Objective physical performance and self-reported exercise measures were collected at WHI baseline ( 1 year prior to calcium/vitamin D enrollment ) and 2 years and 4 years after calcium/vitamin D trial enrollment in a sub sample ( n=3,137 ) . STATISTICAL ANALYSES PERFORMED Calcium/vitamin D effects were tested in unadjusted and interaction linear models for each of the physical function measures . Covariates were baseline total calcium intake , fracture risk score , treatment arm in the hormone therapy and dietary modification trials ( ie , active drug or placebo , low-fat diet intervention or usual diet , respectively ) and age . RESULTS Neither intention to treat nor high adherence analyses produced substantial effects of calcium/vitamin D compared to placebo on physical functioning or performance . The interaction analyses also did not result in differences because of calcium/vitamin D. CONCLUSIONS As the first long-term r and omized trial to examine the effectiveness of calcium and vitamin D in protecting against decline of physical functioning in older women , the results did not support benefit",
"To test the effect of 25(OH)D(3 ) ( HyD ) compared to vitamin D(3 ) on serum 25-hydroxyvitamin D levels ( 25(OH)D ) , lower extremity function , blood pressure , and markers of innate immunity . Twenty healthy postmenopausal women with an average 25(OH)D level of 13.2 ± 3.9 ng/mL ( mean ± SD ) and a mean age of 61.5 ± 7.2 years were r and omized to either 20 µg of HyD or 20 µg ( 800 IU ) of vitamin D(3 ) per day in a double-blind manner . We measured on 14 visits over 4 months , 25(OH)D serum levels , blood pressure , and seven markers of innate immunity ( eotaxin , interleukin [IL]-8 , IL-12 , interferon gamma-induced protein 10 kDa [ IP-10 ] , monocyte chemotactic protein-1 [ MCP-1 ] , macrophage inflammatory protein beta [ MIP-1β ] , and \" Regulated upon Activation , Normal T-cell Expressed , and Secreted \" [ RANTES ] ) . At baseline and at 4 months , a test battery for lower extremity function ( knee extensor and flexor strength , timed up and go , repeated sit-to-st and ) was assessed . All analyses were adjusted for baseline measurement , age , and body mass index . Mean 25(OH)D levels increased to 69.5 ng/mL in the HyD group . This rise was immediate and sustained . Mean 25(OH)D levels increased to 31.0 ng/mL with a slow increase in the vitamin D(3 ) group . Women on HyD compared with vitamin D(3 ) had a 2.8-fold increased odds of maintained or improved lower extremity function ( odds ratio [ OR ] = 2.79 ; 95 % confidence interval [ CI ] , 1.18 - 6.58 ) , and a 5.7-mmHg decrease in systolic blood pressure ( p = 0.0002 ) . Both types of vitamin D contributed to a decrease in five out of seven markers of innate immunity , significantly more pronounced with HyD for eotaxin , IL-12 , MCP-1 , and MIP-1 β . There were no cases of hypercalcemia at any time point . Twenty micrograms ( 20 µg ) of HyD per day result ed in a safe , immediate , and sustained increase in 25(OH)D serum levels in all participants , which may explain its significant benefit on lower extremity function , systolic blood pressure , and innate immune response compared with vitamin D(3 )",
"CONTEXT Studies examining whether vitamin D supplementation increases muscle mass or muscle-specific vitamin D receptor ( VDR ) concentration are lacking . OBJECTIVE Our objective was to determine whether vitamin D₃ 4000 IU/d alters muscle fiber cross-sectional area ( FCSA ) and intramyonuclear VDR concentration over 4 months . DESIGN AND SETTING This was a r and omized , double-blind , placebo-controlled study in a single center . PARTICIPANTS Participants were 21 mobility-limited women ( aged ≥ 65 years ) with serum 25-hydroxyvitamin D ( 25OHD ) levels of 22.5 to 60 nmol/L. MAIN OUTCOME MEASURES Baseline and 4-month FCSA and intramyonuclear VDR were measured from vastus lateralis muscle cross-sections probed for muscle fiber type ( I/IIa/IIx ) and VDR using immunofluorescence . RESULTS At baseline , mean ( ±SD ) age was 78 ± 5 years ; body mass index was 27 ± 5 kg/m² , 25OHD was 46.3 ± 9.5 nmol/L , and a short physical performance battery score was 7.95 ± 1.57 out of 12 . At 4 months , 25OHD level was 52.5 ± 17.1 ( placebo ) vs 80.0 ± 11.5 nmol/L ( vitamin D [ VD ] ; P , and change in 25OHD level was strongly associated with percent change in intramyonuclear VDR concentration-independent of group ( r = 0.87 , P change in intramyonuclear VDR concentration was 7.8 % ± 18.2 % ( placebo ) vs 29.7 % ± 11.7 % ( VD ; P = .03 ) with a more pronounced group difference in type II vs I fibers . Percent change in total ( type I/II ) FCSA was -7.4 % ± 18.9 % ( placebo ) vs 10.6 % ± 20.0 % ( VD ; P = .048 ) . CONCLUSION Vitamin D₃ supplementation increased intramyonuclear VDR concentration by 30 % and increased muscle fiber size by 10 % in older , mobility-limited , vitamin D-insufficient women . Further work is needed to determine whether the observed effect of vitamin D on fiber size is mediated by the VDR and to identify which signaling pathways are involved"
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The Dietary Approach to Stop Hypertension ( DASH ) is recommended to lower blood pressure ( BP ) , but its effects on cardiometabolic biomarkers are unclear . A systematic review and meta- analysis of r and omised controlled trials ( RCT ) was conducted to determine the effects of the DASH diet on cardiovascular risk factors . Medline , Embase and Scopus data bases were search ed from inception to December 2013 . Inclusion criteria were as follows : ( 1 ) DASH diet ; ( 2 ) RCT ; ( 3 ) risk factors including systolic and diastolic BP and glucose , HDL , LDL , TAG and total cholesterol concentrations ; ( 4 ) control group . R and om-effects models were used to determine the pooled effect sizes . Meta-regression analyses were carried out to examine the association between effect sizes , baseline values of the risk factors , BMI , age , quality of trials , salt intake and study duration . A total of twenty articles reporting data for 1917 participants were included in the meta- analysis . The duration of interventions ranged from 2 to 24 weeks . The DASH diet was found to result in significant decreases in systolic BP ( - 5·2 mmHg , 95 % CI - 7·0 , - 3·4 ; P ( - 2·6 mmHg , 95 % CI - 3·5 , - 1·7 ; P ( - 0·20 mmol/l , 95 % CI - 0·31 , - 0·10 ; P LDL ( - 0·10 mmol/l , 95 % CI - 0·20 , - 0·01 ; P= 0·03 ) . Changes in both systolic and diastolic BP were greater in participants with higher baseline BP or BMI . These changes predicted a reduction of approximately 13 % in the 10-year Framingham risk score for CVD . The DASH diet improved cardiovascular risk factors and appeared to have greater beneficial effects in subjects with an increased cardiometabolic risk . The DASH diet is an effective nutritional strategy to prevent CVD
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"BACKGROUND The Dietary Approaches to Stop Hypertension ( DASH ) diet , which emphasizes fruits , vegetables , and low fat dairy products , significantly lowers blood pressure ( BP ) . We conducted a clinical trial to assess the BP response to the DASH diet with an antihypertensive medication , losartan , in participants with essential hypertension . METHODS A total of 55 hypertensive participants were r and omly assigned to 8 weeks of controlled feeding with either a control diet or the DASH diet . Within each diet arm , participants received losartan 50 mg daily or placebo for 4 weeks each , in double blind , r and omized , cross-over fashion . Twenty-four-hour ambulatory BP ( ABP ) was measured at the end of a 2-week run-in period ( baseline ) and after each 4-week intervention period . RESULTS There was no significant change in ABP during the placebo period on the control diet ( n = 28 ) ( -2.3 + /- 1.5/-1.6 + /- 1.0 mm Hg ) , but there was a significant reduction in systolic ABP ( -5.3 + /- 1.5 mm Hg , P DBP ( -2.5 + /- 1.0 mm Hg ) on the DASH diet ( n = 27 ) . Losartan significantly reduced ABP on the control diet ( -6.7 + /- 1.5/-3.7 + /- 1.0 mm Hg , P in African Americans . On the DASH diet , DeltaSBP on losartan was inversely related to basal plasma renin activity ( n = -0.53 , P = .004 ) . CONCLUSIONS The DASH diet enhances the ABP response to losartan in essential hypertension . This effect is particularly marked in African Americans",
"Background —The Dietary Approaches to Stop Hypertension ( DASH ) diet is recommended in the 2005 US Dietary Guidelines . To underst and the potential benefits of DASH on coronary heart disease ( CHD ) , we applied the Framingham risk equations to calculate 10-year risk of developing CHD using data from the DASH trial . Methods and Results —In the DASH trial , 459 individuals with prehypertension or stage-1 hypertension not taking antihypertensive medication were r and omly assigned to 1 of 3 diets : control , fruits and vegetables ( F/V ) , or DASH ( rich in fruits , vegetables , low-fat dairy , and reduced in fats and cholesterol ) . Weight was held constant . Estimated 10-year CHD risk was the primary outcome of this secondary analysis . Among 436 participants with complete data , mean ( SD ) age was 44.7 ( 10.7 ) years , 51 % were male , and 60 % were African-American . Median 10-year CHD risk was 0.98 % at baseline and decreased in all groups . Compared with control , the relative risk ratio comparing 8-week with baseline 10-year CHD risk was 0.93 ( 95 % confidence interval , 0.85 to 1.02 ; P=0.12 ) for F/V and 0.82 ( 95 % confidence interval , 0.75 to 0.90 ; P relative risk ratio was 0.89 ( 95 % confidence interval , 0.81 to 0.97 ; P=0.012 ) . With the exception of an interaction between dietary pattern and race suggesting a greater risk reduction in blacks than whites ( P for interaction=0.038 ) , results were similar across subgroups . Conclusions —Compared with control and F/V , the DASH diet reduced estimated 10-year CHD risk by 18 % and 11 % , respectively . In addition to reducing blood pressure , the DASH diet should substantially reduce the risk of CHD . Clinical Trial Registration —URL : http:// clinical trials.gov . Unique identifier : NCT00000544",
"BACKGROUND Weight loss reduces blood pressure , and the Dietary Approaches to Stop Hypertension ( DASH ) diet has also been shown to lower blood pressure . OBJECTIVE Our goal was to assess the effect on blood pressure of 2 weight-reduction diets : a low-fat diet ( LF diet ) and a moderate-sodium , high-potassium , high-calcium , low-fat DASH diet ( WELL diet ) . DESIGN After baseline measurements , 63 men were r and omly assigned to either the WELL or the LF diet for 12 wk , and both diet groups undertook 0.5 h of moderate physical activity on most days of the week . RESULTS Fifty-four men completed the study . Their mean ( + /-SD ) age was 47.9 + /- 9.3 y ( WELL diet , n = 27 ; LF diet , n = 27 ) , and their mean baseline home systolic and diastolic blood pressures were 129.4 + /- 11.3 and 80.6 + /- 8.6 mm Hg , respectively . Body weight decreased by 4.9 + /- 0.6 kg ( + /-SEM ) in the WELL group and by 4.6 + /- 0.6 kg in the LF group ( P blood pressure in the WELL group than in the LF group [ between-group difference ( week 12 -baseline ) in both SBP ( 5.5 + /- 1.9 mm Hg ; P = 0.006 ) and DBP ( 4.4 + /- 1.2 mm Hg ; P = 0.001 ) ] . CONCLUSIONS For a comparable 5-kg weight loss , a diet high in low-fat dairy products , vegetables , and fruit ( the WELL diet ) result ed in a greater decrease in blood pressure than did the LF diet . This dietary approach to achieving weight reduction may confer an additional benefit in reducing blood pressure in those who are overweight",
"A diet rich in fruits , vegetables , and low-fat dairy foods has been shown to lower blood pressure ( BP ) when all foods are provided . We compared the effect on BP ( measured at home ) of 2 different self-selected diets : a low-sodium , high-potassium diet , rich in fruit and vegetables ( LNAHK ) and a high-calcium diet rich in low-fat dairy foods ( HC ) with a moderate-sodium , high-potassium , high-calcium DASH-type diet , high in fruits , vegetables and low-fat dairy foods ( OD ) . Subjects were r and omly allocated to 2 test diets for 4 wk , the OD and either LNAHK or HC diet , each preceded by a 2 wk control diet ( CD ) . The changes in BP between the preceding CD period and the test diet period ( LNAHK or HC ) were compared with the change between the CD and the OD periods . Of the 56 men and 38 women that completed the OD period , 43 completed the LNAHK diet period and 48 the HC diet period . The mean age was 55.6 + /- 9.9 ( + /-SD ) years . There was a fall in systolic pressure between and the CD and OD [ -1.8 + /- 0.5 mm Hg ( P OD , systolic and diastolic BPs fell during the LNAHK diet period [ -3.5 + /- 1.0 ( P HC diet period [ + 3.1 + /- 0.9 ( P low-sodium , high-potassium diet result ed in a greater fall in BP than a multifaceted OD , confirming the beneficial effect of dietary intervention on BP in a community setting",
"Objective To develop and vali date version two of the QRISK cardiovascular disease risk algorithm ( QRISK2 ) to provide accurate estimates of cardiovascular risk in patients from different ethnic groups in Engl and and Wales and to compare its performance with the modified version of Framingham score recommended by the National Institute for Health and Clinical Excellence ( NICE ) . Design Prospect i ve open cohort study with routinely collected data from general practice , 1 January 1993 to 31 March 2008 . Setting 531 practice s in Engl and and Wales contributing to the national Q RESEARCH data base . Participants 2.3 million patients aged 35 - 74 ( over 16 million person years ) with 140 000 cardiovascular events . Overall population ( derivation and validation cohorts ) comprised 2.22 million people who were white or whose ethnic group was not recorded , 22 013 south Asian , 11 595 black African , 10 402 black Caribbean , and 19 792 from Chinese or other Asian or other ethnic groups . Main outcome measures First ( incident ) diagnosis of cardiovascular disease ( coronary heart disease , stroke , and transient ischaemic attack ) recorded in general practice records or linked Office for National Statistics death certificates . Risk factors included self assigned ethnicity , age , sex , smoking status , systolic blood pressure , ratio of total serum cholesterol : high density lipoprotein cholesterol , body mass index , family history of coronary heart disease in first degree relative under 60 years , Townsend deprivation score , treated hypertension , type 2 diabetes , renal disease , atrial fibrillation , and rheumatoid arthritis . Results The validation statistics indicated that QRISK2 had improved discrimination and calibration compared with the modified Framingham score . The QRISK2 algorithm explained 43 % of the variation in women and 38 % in men compared with 39 % and 35 % , respectively , by the modified Framingham score . Of the 112 156 patients classified as high risk ( that is , ≥20 % risk over 10 years ) by the modified Framingham score , 46 094 ( 41.1 % ) would be reclassified at low risk with QRISK2 . The 10 year observed risk among these reclassified patients was 16.6 % ( 95 % confidence interval 16.1 % to 17.0%)—that is , below the 20 % treatment threshold . Of the 78 024 patients classified at high risk on QRISK2 , 11 962 ( 15.3 % ) would be reclassified at low risk by the modified Framingham score . The 10 year observed risk among these patients was 23.3 % ( 22.2 % to 24.4%)—that is , above the 20 % threshold . In the validation cohort , the annual incidence rate of cardiovascular events among those with a QRISK2 score of ≥20 % was 30.6 per 1000 person years ( 29.8 to 31.5 ) for women and 32.5 per 1000 person years ( 31.9 to 33.1 ) for men . The corresponding figures for the modified Framingham equation were 25.7 per 1000 person years ( 25.0 to 26.3 ) for women and 26.4 ( 26.0 to 26.8 ) for men ) . At the 20 % threshold , the population identified by QRISK2 was at higher risk of a CV event than the population identified by the Framingham score . Conclusions Incorporating ethnicity , deprivation , and other clinical conditions into the QRISK2 algorithm for risk of cardiovascular disease improves the accuracy of identification of those at high risk in a nationally representative population . At the 20 % threshold , QRISK2 is likely to be a more efficient and equitable tool for treatment decisions for the primary prevention of cardiovascular disease . As 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 advised",
"This study examined the effects of the Dietary Approaches to Stop Hypertension ( DASH ) diet on insulin sensitivity and lipids . In a r and omized control trial , 144 overweight ( body mass index : 25 to 40 ) men ( n=47 ) and women ( n=97 ) with high blood pressure ( 130 to 159/85 to 99 mm Hg ) were r and omly assigned to one of the following groups : ( 1 ) DASH diet alone ; ( 2 ) DASH diet with aerobic exercise and caloric restriction ; or ( 3 ) usual diet controls ( UC ) . Body composition , fitness , insulin sensitivity , and fasting lipids were measured before and after 4 months of treatment . Insulin sensitivity was estimated on the basis of glucose and insulin levels in the fasting state and after an oral glucose load . Participants in the DASH diet with aerobic exercise and caloric restriction condition lost weight ( −8.7 kg [ 95 % CI : −2.0 to −9.7 kg ] ) and exhibited a significant increase in aerobic capacity , whereas the DASH diet alone and UC participants maintained their weight ( −0.3 kg [ 95 % CI : −1.2 to 0.5 kg ] and + 0.9 kg [ 95 % CI : 0.0 to 1.7 kg ] , respectively ) and had no improvement in exercise capacity . DASH diet with aerobic exercise and caloric restriction demonstrated lower glucose levels after the oral glucose load , improved insulin sensitivity , and lower total cholesterol and triglycerides compared with both DASH diet alone and UC , as well as lower fasting glucose and low-density lipoprotein cholesterol compared with UC . DASH diet alone participants generally did not differ from UC in these measures . Combining the DASH diet with exercise and weight loss result ed in significant improvements in insulin sensitivity and lipids . Despite clinical ly significant reductions in blood pressure , the DASH diet alone , without caloric restriction or exercise , result ed in minimal improvements in insulin sensitivity or lipids ",
"OBJECTIVE To determine the effects of the Dietary Approaches to Stop Hypertension ( DASH ) eating pattern on cardiometabolic risks in type 2 diabetic patients . RESEARCH DESIGN AND METHODS A r and omized crossover clinical trial was undertaken in 31 type 2 diabetic patients . For 8 weeks , participants were r and omly assigned to a control diet or the DASH eating pattern . RESULTS After following the DASH eating pattern , body weight ( P = 0.007 ) and waist circumference ( P = 0.002 ) reduced significantly . Fasting blood glucose levels and A1C decreased after adoption of the DASH diet ( −29.4 ± 6.3 mg/dl ; P = 0.04 and −1.7 ± 0.1 % ; P = 0.04 , respectively ) . After the DASH diet , the mean change for HDL cholesterol levels was higher ( 4.3 ± 0.9 mg/dl ; P = 0.001 ) and LDL cholesterol was reduced ( −17.2 ± 3.5 mg/dl ; P = 0.02 ) . Additionally , DASH had beneficial effects on systolic ( −13.6 ± 3.5 vs. −3.1 ± 2.7 mmHg ; P = 0.02 ) and diastolic blood pressure ( −9.5 ± 2.6 vs. −0.7 ± 3.3 mmHg ; P = 0.04 ) . CONCLUSIONS Among diabetic patients , the DASH diet had beneficial effects on cardiometabolic risks",
"Abstract — Evidence suggests that obesity may raise blood pressure ( BP ) through oxidative stress – sensitive mechanisms and that the Dietary Approaches to Stop Hypertension combination diet ( DASH-CD ) may decrease BP by enhancing antioxidant capacity . To address this question , 12 obese patients with high-normal – to – stage 1 hypertension ( hypertensives ) and 12 lean normotensives were studied on their usual diets and after following the DASH-CD and a low-antioxidant diet in r and om sequence for 4 weeks each . Acute oxidative stress was induced by a 4-hour infusion of intralipid and heparin . Ferric-reducing activity of plasma ( FRAP ) and plasma F2-isoprostanes were measured as biomarkers of antioxidant capacity and oxidative stress , respectively . BP was lower in obese hypertensives on the DASH-CD than on the usual and low-antioxidant diets ( −8.1±1.5/−7.4±1.6 mm Hg , P ) . BP did not change significantly in lean normotensives after 4 weeks on the DASH-CD but tended to rise on the low-antioxidant diet . FRAP on usual diets was higher in lean subjects than in obese subjects . FRAP increased in obese but not lean volunteers on the DASH-CD compared with usual diet , and the group difference disappeared . F2-isoprostanes increased from baseline during intralipid and heparin in both groups on the low-antioxidant diet but not in obese hypertensives on the DASH-CD . Among free-living obese hypertensives , the DASH-CD raises antioxidant capacity , lowers BP , and reduces oxidative stress induced by acute hyperlipidemia . The findings are consistent with evidence that elevated BP in obese subjects may reflect an imbalance between antioxidant capacity and oxidative stress that is improved by the DASH-CD ",
"The mechanism underlying blood pressure ( BP ) reduction in the high fruits and vegetables arm of the Dietary Approaches to Stop Hypertension ( DASH ) study is unknown but may include potassium , magnesium and fibre . This study was design ed to separate minerals and fibre from other components of DASH on BP in abdominally obese individuals with metabolic syndrome with pre-hypertension to stage 1 hypertension ( obese hypertensives ) . A total of 15 obese hypertensives and 15 lean normotensives were studied on a st and ardized usual diet , r and omized to DASH or usual diet supplemented with potassium , magnesium and fibre to match DASH , then crossed over to the complementary diet . All diets were 3 weeks long , isocaloric and matched for sodium and calcium . In obese hypertensives , BP was lower after 3 weeks on DASH than usual diet ( −7.6±1.4/−5.3±1.4 mm Hg , P ) , whereas BP was not significantly different on usual and supplemented diets . BP values were not different among the three diets in lean normotensives . Small artery elasticity was lower in obese hypertensives than in lean normotensives on the usual and supplemented diets ( P . This index of endothelial function improved in obese hypertensives ( P0.50 ) . DASH is more effective than potassium , magnesium and fibre supplements for lowering BP in obese hypertensives , which suggest that high fruits and vegetables DASH lowers BP and improves endothelial function in this group by nutritional factors in addition to potassium , magnesium and fibre",
"This pilot study aims to provide effect size confidence intervals , clinical trial and intervention feasibility data , and procedural material s for a full-scale r and omized controlled trial that will determine the efficacy of Dietary Approaches to Stop Hypertension ( DASH ) as adjunct therapy to st and ard care for adults with uncontrolled asthma . The DASH diet encompasses foods ( e.g. , fresh fruit , vegetables , and nuts ) and antioxidant nutrients ( e.g. , vitamins A , C , E , and zinc ) with potential benefits for persons with asthma , but it is unknown whether the whole diet is beneficial . Participants ( n = 90 ) will be r and omized to receive usual care alone or combined with a DASH intervention consisting of 8 group and 3 individual sessions during the first 3 months , followed by at least monthly phone consultations for another 3 months . Follow-up assessment s will occur at 3 and 6 months . The primary outcome measure is the 7-item Juniper Asthma Control Question naire , a vali date d composite measure of daytime and nocturnal symptoms , activity limitations , rescue medication use , and percentage predicted forced expiratory volume in 1 second . We will explore changes in inflammatory markers important to asthma pathophysiology ( e.g. , fractional exhaled nitric oxide ) and their potential to mediate the intervention effect on disease control . We will also conduct pre-specified subgroup analyses by genotype ( e.g. , polymorphisms on the glutathione S transferase gene ) and phenotype ( e.g. , atopy , obesity ) . By evaluating a dietary pattern approach to improving asthma control , this study could advance the evidence base for refining clinical guidelines and public health recommendations regarding the role of dietary modifications in asthma management",
"Background Dietary Approaches to Stop Hypertension ( DASH ) has been shown to successfully reduce systolic ( SBP ) and diastolic blood pressure ( DBP ) when evaluated in clinical ly controlled environments but there is a lack of information regarding the efficacy of the original DASH diet when it is applied in a free-living environment . Purpose To provide descriptive data as to the changes in blood pressure individuals could expect to achieve when following the DASH diet in a free-living environment for 4-weeks with no additional behavioral modifications . Methods Twenty , pre- and stage 1 hypertensive participants were r and omly split into 2 groups ; DASH ( males N = 5 , females N = 5 , age = 38.5 ± 10.8 ) and control ( males N = 7 , females N = 3 , age = 38.1 ± 11.1 ) . The DASH group was instructed on how to follow the DASH diet on their own for 4-weeks while the control group continued their normal diet . SBP , DBP , body weight , 3-day food diaries and physical activity recall question naire data were collected pre and post intervention using a traditional person-to-person instructional technique . Results Two-way ANOVA demonstrated that there was a significant group ( DASH , control ) by time ( pre , post ) interaction for SBP ( P = 0.003 ) and no significant effects for DBP . The interaction was due to a significant reduction ( P in SBP in the DASH group ( pre : 141.3 ± 11.3 mmHg vs. post : 130.7 ± 9.1 mmHg ) over the course of the intervention with no change in SBP in the control group ( pre : 133.5 ± 6.6 mmHg vs. post : 131.9 ± 8.9 mmHg ) . Pearson 's correlation analyses revealed that changes in potential moderators of blood pressure including body weight , BMI , sodium intake and total kilocalories were each not associated with changes in SBP ( r ≤ 0.14 , P ≥ 0.5 ) or DBP ( r physical activity during the intervention . Conclusion DASH diet followed in a free-living environment significantly reduced SBP but not DBP . However , the changes in SBP and DBP were very similar to those noted in controlled clinical feeding evaluations of the DASH diet . Presently , none of the potential moderators of blood pressure that were assessed were independently associated with the observed changes in blood pressure which may be due to our small sample size or the possibility that it is the combined change in multiple factors that lead to reductions in blood pressure when following the DASH diet",
"OBJECTIVE To our knowledge , no reports are available indicating the effects of the dietary approaches to stop hypertension ( DASH ) eating plan on insulin resistance , inflammation , and oxidative stress among pregnant women with gestational diabetes mellitus ( GDM ) . This study was design ed to investigate the effects of the DASH diet on insulin resistance , serum high-sensitivity C-reactive protein ( hs-CRP ) and biomarkers of oxidative stress among pregnant women with GDM . METHODS This r and omized controlled clinical trial was performed with 32 pregnant women diagnosed with GDM at 24 to 28 wk gestation . Participants were r and omly assigned to consume either the control ( n = 16 ) or DASH diet ( n = 16 ) for 4 wk . The DASH diet was rich in fruits , vegetables , whole grains , and low-fat dairy products and was low in saturated fats , total fats , cholesterol , refined grains , and sweets , with a total of 2400 mg/d of sodium . The control diet contained 40 % to 55 % of its energy as carbohydrates , 10 % to 20 % as proteins , and 25 % to 30 % as total fats . Fasting blood sample s were taken at baseline and after 4 wk of intervention to measure fasting plasma glucose ( FPG ) , serum insulin , and hs-CRP , homeostasis model of assessment -insulin resistance ( HOMA-IR ) , plasma total antioxidant capacity ( TAC ) , and total glutathione levels ( GSH ) . RESULTS Consumption of the DASH diet compared with the control diet result ed in decreased FPG ( -7.62 versus 3.68 mg/dL ; P = 0.02 ) , serum insulin levels ( -2.62 versus 4.32 μIU/mL , P = 0.03 ) , and HOMA-IR score ( -0.8 versus 1.1 ; P = 0.03 ) . Increased concentrations of plasma TAC ( 45.2 versus -159.2 mmol/L ; P of serum hs-CRP levels between the two diets . Within-group comparisons revealed significant reductions in plasma TAC and GSH levels in the control diet , while a significant increase in these biomarkers in the DASH diet . CONCLUSION Consumption of the DASH diet in pregnant women with GDM had beneficial effects on FPG , serum insulin levels , HOMA-IR score , plasma TAC , and total GSH levels . The effects of this dietary pattern on pregnancy outcomes need to be investigated in future studies",
"Abstract —Blood pressure-lowering mechanisms of the Dietary Approaches to Stop Hypertension ( DASH ) diet , rich in fruits , vegetables , and low-fat dairy foods , were analyzed based on the pressure-natriuresis relationship . Participants ( n=375 ) were r and omly assigned to control or DASH diet groups by using a parallel-group design . They then ate their assigned diet for 3 consecutive 30-day intervention feeding periods , during which sodium intake varied among 3 levels by a r and omly assigned sequence . Urinary sodium excretion rate and mean arterial pressure were measured at the end of each sodium intake level . Mean arterial pressure and urinary sodium excretion were plotted on x and y axes , respectively , for participants eating control and DASH diets and were modeled as linear relationships for simplicity to allow the estimation of the extrapolated x-intercept and slope of the relationships . The DASH diet steepened the slope of the relationship ( 29.5±3.4 vs 64.9±13.1 [mmol/d]/mm Hg , P = 0.0002 ) without significantly shifting the x-intercept ( 94.1±0.5 vs 93.2±0.6 mm Hg , NS ) of the relationship . These data suggest a natriuretic action of the DASH diet",
"BACKGROUND It is known that obesity , sodium intake , and alcohol consumption factors influence blood pressure . In this clinical trial , Dietary Approaches to Stop Hypertension , we assessed the effects of dietary patterns on blood pressure . METHODS We enrolled 459 adults with systolic blood pressures of less than 160 mm Hg and diastolic blood pressures of 80 to 95 mm Hg . For three weeks , the subjects were fed a control diet that was low in fruits , vegetables , and dairy products , with a fat content typical of the average diet in the United States . They were then r and omly assigned to receive for eight weeks the control diet , a diet rich in fruits and vegetables , or a \" combination \" diet rich in fruits , vegetables , and low-fat dairy products and with reduced saturated and total fat . Sodium intake and body weight were maintained at constant levels . RESULTS At base line , the mean ( + /-SD ) systolic and diastolic blood pressures were 131.3+/-10.8 mm Hg and 84.7+/-4.7 mm Hg , respectively . The combination diet reduced systolic and diastolic blood pressure by 5.5 and 3.0 mm Hg more , respectively , than the control diet ( P systolic blood pressure by 2.8 mm Hg more ( P diastolic blood pressure by 1.1 mm Hg more than the control diet ( P=0.07 ) . Among the 133 subjects with hypertension ( systolic pressure , > or = 140 mm Hg ; diastolic pressure , > or = 90 mm Hg ; or both ) , the combination diet reduced systolic and diastolic blood pressure by 11.4 and 5.5 mm Hg more , respectively , than the control diet ( P 326 subjects without hypertension , the corresponding reductions were 3.5 mm Hg ( P blood pressure . This diet offers an additional nutritional approach to preventing and treating hypertension",
"Potential blood pressure- ( BP- ) lowering mechanisms of the DASH dietary pattern were measured in 20 unmedicated hypertensive adults in a controlled feeding study . At screening , participants averaged 44.3 ± 7.8 years , BMI 33.9 ± 6.6 Kg/m2 , and BP 144.2 ± 9.38/88.5 ± 6.03 mmHg . All consumed a control diet for one week , then were r and omized to control or DASH for another two weeks ( week one and two ) . With DASH , but not controls , SBP fell by 10.65 ± 12.89 ( P = 0.023 ) and 9.60 ± 11.23 ( P = 0.039 ) mmHg and DBP by 5.95 ± 8.01 ( P = 0.069 ) and 8.60 ± 9.13 mmHg ( P = 0.011 ) at the end of week one and two , respectively . Univariate regressions showed that changes in urinary sodium/potassium ratio ( β = 1.99 ) and plasma renin activity ( β = −15.78 ) and percent change in plasma nitrite after hyperemia were associated with SBP changes at week one ( all P following hyperemia showed a treatment effect ( P = 0.014 ) and increased at week two ( P = 0.001 ) . Pulse wave velocity decreased over time with DASH ( trend P = 0.019 ) , and reached significance at week two ( P = 0.026 ) . This response may be mediated by an improvement in upregulation of nitric oxide bioavailability . Early natriuresis and reductions in oxidative stress can not be ruled out . Future studies are needed to verify these findings , assess the possibility of earlier effects , and examine other potential mediators",
"Salt induces oxidative stress in salt-sensitive ( SS ) animals and man . It is not known whether in SS subjects the low-sodium dietary approaches to stop hypertension ( LS-DASH ) reduces oxidative stress more than DASH , which is high in antioxidants . To assess the effects of DASH and LS-DASH on oxidative stress , 19 volunteers were studied after 3 weeks of a st and ardized usual low fruits and vegetables diet ( ULFV ) , followed by 3 weeks on DASH ( both diets ∼120 mmol Na+ per day ) , then 3 weeks on LS-DASH ( 60 mmol Na+ per day ) . SS was defined as systolic blood pressure ⩾5 mm Hg lower on LS-DASH than DASH . In SS subjects ( N=9 ) , systolic blood pressure was lower on LS-DASH ( 111.0±2.0 mm Hg ) than DASH ( 118.0±2.2 , P ) . In salt-resistant ( SR ) volunteers ( N=10 ) , systolic blood pressure was lower on DASH ( 113.0±1.6 ) than ULFV ( 119.0±1.8 , P ) . Urine F2-isoprostanes , a marker of oxidative stress , were lower in SS subjects on LS-DASH ( 1.69±0.24 ) than ULFV ( 3.09±0.50 , P P were not different among the three diets in SR volunteers ( 2.18±0.29 , 2.06±0.29 , 2.27±0.53 , respectively ) . Aortic augmentation index , a measure of vascular stiffness , was lower in SS subjects on LS-DASH than either DASH or ULFV , and lower on DASH than ULFV in SR volunteers . In SS but not SR subjects , LS-DASH is associated with lower values for F2-isoprostanes and the aortic augmentation index . The results suggest that LS-DASH decreases oxidative stress , improves vascular function and lowers blood pressure in SS but not SR volunteers",
"Low-sodium Dietary Approaches to Stop Hypertension ( DASH ) diets are base producing but restrict red meat without clear justification . We hypothesized that a vitality diet ( VD ) , a low-sodium DASH-type diet with a low dietary acid load containing 6 servings of 100 g cooked lean red meat per week , would be more effective in reducing blood pressure ( BP ) compared with a higher acid load reference healthy diet ( RHD ) based on general dietary guidelines to reduce fat intake and increase intake of breads and cereals . A r and omized , parallel dietary intervention study was conducted to compare the BP-lowering effect of these 2 diets in postmenopausal women with high/normal BP . Women were r and omly assigned to follow either VD or RHD for 14 weeks . Home BP was measured daily with an automated BP monitor under st and ard conditions . Of 111 women commencing the study , 95 completed ( 46 VD , 49 RHD ) . Systolic BP ( SBP ) throughout the intervention was lower in the VD group compared to the RHD group ( repeated- measures analysis of variance time by diet , P = .04 ) , such that at the end of the study , the VD had a fall of SBP by 5.6 + /- 1.3 mm Hg ( mean + /- SEM ) compared with a fall of 2.7 + /- 1.0 mm Hg in the RHD ( group difference , P = .08 ) . When only those taking antihypertensive medications were assessed , the VD ( n = 17 ) had a significant fall of 6.5 + /- 2.5 mm Hg SBP ( P = .02 ) and 4.6 + /- 1.4 mm Hg diastolic BP ( P = .005 ) after 14 weeks , and their BP was lower than that of the RHD group ( n = 18 ) throughout the study ( P low-sodium DASH diet with a low dietary acid load , which also included lean red meat on most days of the week , was effective in reducing BP in older women , particularly in those taking antihypertensive medications",
"We tested whether lowering of blood pressure ( BP ) on the dietary approaches to stop hypertension ( DASH ) diet was associated with changes in peripheral vascular function : endothelial function , assessed by flow-mediated vasodilatation ( FMD ) of the brachial artery , and subcutaneous adipose tissue blood flow ( ATBF ) . We also assessed effects on heart rate variability ( HRV ) as a measure of autonomic control of the heart . We allocated 27 men and women to DASH diet and control groups . We measured FMD , ATBF and HRV on fasting and after ingestion of 75 g glucose , before and after 30 days on dietary intervention , aim ing for weight maintenance . The control group did not change their diet . The DASH-diet group complied with the diet as shown by significant reductions in systolic ( P and diastolic ( P=0.005 ) BP , and in plasma C-reactive protein ( P LDL-cholesterol ( P apolipoprotein B ( P=0.001 ) , a novel finding . Body weight changed by FMD , or in ATBF , in the DASH-diet group , although heart rate fell ( P Glucose and insulin concentrations did not change . In this small-scale study , the DASH diet lowered BP independently of peripheral mechanisms",
"BACKGROUND Although the DASH ( Dietary Approaches to Stop Hypertension ) diet has been shown to lower blood pressure ( BP ) in short-term feeding studies , it has not been shown to lower BP among free-living individuals , nor has it been shown to alter cardiovascular biomarkers of risk . OBJECTIVE To compare the DASH diet alone or combined with a weight management program with usual diet controls among participants with prehypertension or stage 1 hypertension ( systolic BP , 130 - 159 mm Hg ; or diastolic BP , 85 - 99 mm Hg ) . DESIGN AND SETTING R and omized , controlled trial in a tertiary care medical center with assessment s at baseline and 4 months . Enrollment began October 29 , 2003 , and ended July 28 , 2008 . PARTICIPANTS Overweight or obese , unmedicated out patients with high BP ( N = 144 ) . INTERVENTIONS Usual diet controls , DASH diet alone , and DASH diet plus weight management . OUTCOME MEASURES The main outcome measure is BP measured in the clinic and by ambulatory BP monitoring . Secondary outcomes included pulse wave velocity , flow-mediated dilation of the brachial artery , baroreflex sensitivity , and left ventricular mass . RESULTS Clinic-measured BP was reduced by 16.1/9.9 mm Hg ( DASH plus weight management ) ; 11.2/7.5 mm ( DASH alone ) ; and 3.4/3.8 mm ( usual diet controls ) ( P ambulatory BP ( P pulse wave velocity , baroreflex sensitivity , and left ventricular mass ( all P overweight or obese persons with above-normal BP , the addition of exercise and weight loss to the DASH diet result ed in even larger BP reductions , greater improvements in vascular and autonomic function , and reduced left ventricular mass . CLINICAL TRIAL REGISTRATION clinical trials.gov Identifier : NCT00571844",
"Although gestational diabetes mellitus ( GDM ) is associated with an increased risk of maternal and neonatal morbidity , there is no consensus as to the optimal approach of nutritional management in these patients . The present study was design ed to assess the effect of the Dietary Approaches to Stop Hypertension ( DASH ) eating plan on glucose tolerance and lipid profiles of pregnant women with GDM . The present r and omised controlled clinical trial was performed among thirty-four women diagnosed with GDM at 24 - 28 weeks of gestation . Subjects were r and omly assigned to consume either the control diet ( n 17 ) or the DASH eating pattern ( n 17 ) for 4 weeks . The control diet was design ed to contain 45 - 55 % carbohydrates , 15 - 20 % protein and 25 - 30 % total fat . The macronutrient composition of the DASH diet was similar to the control diet ; however , the DASH diet was rich in fruits , vegetables , whole grains and low-fat dairy products , and contained lower amounts of saturated fats , cholesterol and refined grains with a total of 2400 mg Na/d . Fasting blood sample s were taken at baseline and after 4 weeks of intervention to measure fasting plasma glucose , glycated Hb ( HbA1c ) and lipid profiles . Participants underwent a 3 h oral glucose tolerance tests and blood sample s were collected at 60 , 120 and 180 min to measure plasma glucose levels . Adherence to the DASH eating pattern , compared with the control diet , result ed in improved glucose tolerance such that plasma glucose levels reduced at 60 ( 21·86 v. 20·45 mmol/l , Pgroup = 0·02 ) , 120 ( 22·3 v. 0·2 mmol/l , Pgroup = 0·001 ) and 180 min ( 21·7 v. 0·22 mmol/l , Pgroup = 0·002 ) after the glucose load . Decreased HbA1c levels ( 20·2 v. 0·05 % , Pgroup = 0·001 ) was also seen in the DASH group compared with the control group . Mean changes for serum total ( 20·42 v. 0·31 mmol/l , Pgroup = 0·01 ) and LDL-cholesterol ( 20·47 v. 0·22 mmol/l , Pgroup = 0·005 ) , TAG ( 20·17 v. 0·34 mmol/l , Pgroup = 0·01 ) and total : HDL-cholesterol ratio ( 20·6 ( SD 0·9 ) v. 0·3 ( SD 0·8 ) , Pgroup = 0·008 ) were significantly different between the two diets . Additionally , consumption of the DASH diet favourably influenced systolic blood pressure ( 22·6 v. 1·7 mmHg , Pgroup = 0·001 ) . Mean changes of fasting plasma glucose ( 20·29 v. 0·15 mmol/l , Pgroup = 0·09 ) were nonsignificant comparing the DASH diet with the control diet . In conclusion , consumption of the DASH eating pattern for 4 weeks among pregnant women with GDM result ed in beneficial effects on glucose tolerance and lipid profiles compared with the control diet",
"BACKGROUND The Dietary Approaches to Stop Hypertension ( DASH ) diet is widely promoted in the USA for the prevention and treatment of high blood pressure . It is high in fruit and vegetables , low-fat dairy and wholegrain foods and low in saturated fat and refined sugar . To our knowledge , the use of this dietary pattern has not been assessed in a free-living UK population . METHODS The DASH diet was adapted to fit UK food preferences and portion sizes . Fourteen healthy subjects followed the adapted DASH diet for 30 days in which they self-selected all food and beverages . Dietary intake was assessed by 5-day food diaries completed before and towards the end of the study . Blood pressure was measured at the beginning and end of the study to assess compliance to the DASH style diet . RESULTS The DASH diet was easily adapted to fit with UK food preferences . Furthermore , it was well tolerated and accepted by subjects . When on the DASH style diet , subjects reported consuming significantly ( P carbohydrate and protein and less total fat ( 5 % , 6 % and 9 % total energy , respectively ) . Sodium intakes decreased by 860 mg day(-1 ) ( P Systolic and diastolic blood pressure decreased significantly ( P DASH style diet . CONCLUSIONS The DASH style diet was well accepted and was associated with a decrease in blood pressure in normotensive individuals and should be considered when giving dietary advice to people with elevated blood pressure in the UK",
"Abstract —We evaluated the effect on serum lipids of sodium intake in 2 diets . Participants were r and omly assigned to a typical American control diet or the Dietary Approaches to Stop Hypertension ( DASH ) diet , each prepared with 3 levels of sodium ( targeted at 50 , 100 , and 150 mmol/d per 2100 kcal ) . The DASH diet is increased in fruits , vegetables , and low-fat dairy products and is reduced in saturated and total fat . Within assigned diet , participants ate each sodium level for 30 days . The order of sodium intake was r and om . Participants were 390 adults , age 22 years or older , with blood pressure of 120 to 159 mm Hg systolic and 80 to 95 mm Hg diastolic . Serum lipids were measured at baseline and at the end of each sodium period . Within each diet , sodium intake did not significantly affect serum total cholesterol , LDL cholesterol , HDL cholesterol , or triglycerides . On the control diet , the ratio of total cholesterol-to-HDL cholesterol increased by 2 % from 4.53 on higher sodium to 4.63 on lower sodium intake ( P = 0.04 ) . On the DASH diet , sodium intake did not affect this ratio . There was no dose-response of sodium intake on serum lipids or the cholesterol ratio in either diet . At each sodium level , total cholesterol , LDL cholesterol , and HDL cholesterol were lower on the DASH diet versus the typical American diet . There were no significant interactions between the effects of sodium and the DASH diet on serum lipids . In conclusion , changes in dietary sodium intake over the range of 50 to 150 mmol/d did not affect blood lipid concentrations",
"CONTEXT Weight loss , sodium reduction , increased physical activity , and limited alcohol intake are established recommendations that reduce blood pressure ( BP ) . The Dietary Approaches to Stop Hypertension ( DASH ) diet also lowers BP . To date , no trial has evaluated the effects of simultaneously implementing these lifestyle recommendations . OBJECTIVE To determine the effect on BP of 2 multicomponent , behavioral interventions . DESIGN , SETTING , AND PARTICIPANTS R and omized trial with enrollment at 4 clinical centers ( January 2000-June 2001 ) among 810 adults ( mean [ SD ] age , 50 [ 8.9 ] years ; 62 % women ; 34 % African American ) with above-optimal BP , including stage 1 hypertension ( 120 - 159 mm Hg systolic and 80 - 95 mm Hg diastolic ) , and who were not taking antihypertensive medications . INTERVENTION Participants were r and omized to one of 3 intervention groups : ( 1 ) \" established , \" a behavioral intervention that implemented established recommendations ( n = 268 ) ; ( 2 ) \" established plus DASH,\"which also implemented the DASH diet ( n = 269 ) ; and ( 3 ) an \" advice only \" comparison group ( n = 273 ) . MAIN OUTCOME MEASURES Blood pressure measurement and hypertension status at 6 months . RESULTS Both behavioral interventions significantly reduced weight , improved fitness , and lowered sodium intake . The established plus DASH intervention also increased fruit , vegetable , and dairy intake . Across the groups , gradients in BP and hypertensive status were evident . After subtracting change in advice only , the mean net reduction in systolic BP was 3.7 mm Hg ( P systolic BP difference between the established and established plus DASH groups was 0.6 mm Hg ( P = .43 ) . Compared with the baseline hypertension prevalence of 38 % , the prevalence at 6 months was 26 % in the advice only group , 17 % in the established group ( P = .01 compared with the advice only group ) , and 12 % in the established plus DASH group ( P optimal BP ( plus DASH group ( P Individuals with above-optimal BP , including stage 1 hypertension , can make multiple lifestyle changes that lower BP and reduce their cardiovascular disease risk",
"Few studies exist regarding the effects of the Dietary Approaches to Stop Hypertension ( DASH ) diet on novel cardiovascular risk factors among type 2 diabetic patients . We evaluated the effects of the DASH eating pattern on C-reactive protein ( CRP ) level , coagulation abnormalities , and hepatic function tests in type 2 diabetic patients . In this r and omized , crossover clinical trial , 31 type 2 diabetic patients consumed a control diet or the DASH diet for 8 wk . The DASH diet was rich in fruits , vegetables , whole grains , and low-fat dairy products and low in saturated fat , total fat , cholesterol , refined grains , and sweets , with a total of 2400 mg/d sodium . The control diet was a st and ard diet for diabetic patients . There was a 4-wk washout between the 2 trial phases . The main outcome measures were CRP level , coagulation indices , and hepatic function tests . The mean percent change for plasma CRP level was -26.9 ± 3.5 % after the DASH diet period and -5.1 ± 3.8 % after the control diet period ( P = 0.02 ) . Decreases in both alanine aminotransferase and aspartate aminotransferase levels were greater after consuming the DASH diet compared with the control diet ( -14.8 ± 3.0 % vs -6.6 ± 3.4 % ; P = 0.001 ; -29.4 ± 3.7 % vs -5.9 ± 1.4 % ; P = 0.001 , respectively ) . The decrease in the plasma fibrinogen level during the DASH diet period ( -11.4 ± 3.6 % ) was greater than that during the control diet ( 0.5 ± 3.4 % ) ( P = 0.03 ) . Among diabetic patients , the DASH diet can play an important role in reducing inflammation , plasma levels of fibrinogen , and liver aminotransferases . Future longer term studies are recommended"
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Context Current dietary guidelines for cardiovascular disease risk management recommend restricting intake of saturated fatty acids ( SFAs ) . However , the optimal macronutrient profile , in the context of a low-SFA diet , remains controversial . The blood-pressure effect of replacing SFAs in diets with monounsaturated fatty acids ( MUFAs ) compared with carbohydrate has not been quantified to date . Objective To synthesize the evidence for the effect of substituting a high-carbohydrate ( high-CHO ) diet for a high-monounsaturated fatty acid ( high-MUFA ) diet on blood pressure , a systematic review and meta- analysis of r and omized clinical trials in a population without health restrictions was conducted . Data Sources MEDLINE , EMBASE , and Cochrane Central Register of Controlled Clinical Trials were search ed through June 7 , 2017 . R and omized controlled trials of > 3 weeks duration that assessed the effect of high-MUFA diets in isocaloric substitution for high-CHO diets on systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) were included . Data Extraction Data were pooled using the generic-inverse variance method with r and om effects models and expressed as mean differences ( MDs ) with 95 % confidence intervals ( CIs ) . Heterogeneity was assessed by Cochran Q statistic and quantified by the I2 statistic . The quality of the evidence was assessed with the Grading of Recommendations Assessment , Development , and Evaluation ( GRADE ) system . Results Fourteen trials ( n = 980 participants ) were included in the analysis . Comparatively , the high-MUFA diets in isocaloric substitution for high-CHO diets did not demonstrate a greater reduction in blood pressure ( SBP : MD , -0.08 mmHg [ 95%CI , -1.01 to 0.84 ] , P = 0.86 ; DBP : MD = 0.01 mmHg [ 95%CI , -0.73 to 0.75 ] , P = 0.98 ) . The overall quality of the evidence was assessed as moderate . Conclusions In the context of low SFAs , high-MUFA diets in isocaloric substitution for high-CHO diets did not affect blood pressure in individuals with and without hypertension . Large-scale trials achieving higher MUFA targets are required to support these findings . Clinical Trials.gov ID NCT02626325
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"CONTEXT Reduced intake of saturated fat is widely recommended for prevention of cardiovascular disease . The type of macronutrient that should replace saturated fat remains uncertain . OBJECTIVE To compare the effects of 3 healthful diets , each with reduced saturated fat intake , on blood pressure and serum lipids . DESIGN , SETTING , AND PARTICIPANTS R and omized , 3-period , crossover feeding study ( April 2003 to June 2005 ) conducted in Baltimore , Md , and Boston , Mass. Participants were 164 adults with prehypertension or stage 1 hypertension . Each feeding period lasted 6 weeks and body weight was kept constant . INTERVENTIONS A diet rich in carbohydrates ; a diet rich in protein , about half from plant sources ; and a diet rich in unsaturated fat , predominantly monounsaturated fat . MAIN OUTCOME MEASURES Systolic blood pressure and low-density lipoprotein cholesterol . RESULTS Blood pressure , low-density lipoprotein cholesterol , and estimated coronary heart disease risk were lower on each diet compared with baseline . Compared with the carbohydrate diet , the protein diet further decreased mean systolic blood pressure by 1.4 mm Hg ( P = .002 ) and by 3.5 mm Hg ( P = .006 ) among those with hypertension and decreased low-density lipoprotein cholesterol by 3.3 mg/dL ( 0.09 mmol/L ; P = .01 ) , high-density lipoprotein cholesterol by 1.3 mg/dL ( 0.03 mmol/L ; P = .02 ) , and triglycerides by 15.7 mg/dL ( 0.18 mmol/L ; P diet , the unsaturated fat diet decreased systolic blood pressure by 1.3 mm Hg ( P = .005 ) and by 2.9 mm Hg among those with hypertension ( P = .02 ) , had no significant effect on low-density lipoprotein cholesterol , increased high-density lipoprotein cholesterol by 1.1 mg/dL ( 0.03 mmol/L ; P = .03 ) , and lowered triglycerides by 9.6 mg/dL ( 0.11 mmol/L ; P = .02 ) . Compared with the carbohydrate diet , estimated 10-year coronary heart disease risk was lower and similar on the protein and unsaturated fat diets . CONCLUSION In the setting of a healthful diet , partial substitution of carbohydrate with either protein or monounsaturated fat can further lower blood pressure , improve lipid levels , and reduce estimated cardiovascular risk . Clinical Trials Registration Clinical Trials.gov Identifier : NCT00051350",
"BACKGROUND Hemostasis is the result of a complex equilibrium between coagulation and fibrinolysis , and the influence of different dietary models on this equilibrium is not entirely known . OBJECTIVE The objective was to compare the effects of the chronic intake of different dietary models on postpr and ial hemostasis . DESIGN In a r and omized crossover design , 20 healthy men consumed for 28 d each diets rich in monounsaturated fatty acids ( MUFAs ) , saturated fatty acids ( SFAs ) , and carbohydrates plus n-3 fatty acids ( CHO/N3 ) . Fasting and postpr and ial hemostatic factors ( factor VII coagulant activity , plasminogen activator inhibitor-1 , tissue-type plasminogen activator , d-dimer , and thromboxane B(2 ) ) were measured ; meal tests for the postpr and ial measures were based on butter , virgin olive oil , and walnuts for the SFA , MUFA , and CHO/N3 diets , respectively . RESULTS There were no differences in the fasting variables after the dietary periods . After the 3 fatty meals were consumed , we observed an increase in thromboxane B(2 ) and d-dimer and a reduction in tissue plasminogen activator , irrespective of the dietary model . The MUFA or CHO/N3 meals lowered postpr and ial concentrations of factor VII coagulant activity , although the reduction was greater after the MUFA-enriched meal . The concentration of plasminogen activator inhibitor-1 was greater after the SFA meal than after the other 2 meals . CONCLUSIONS The administration of a fatty meal induces a postpr and ial procoagulant tendency , irrespective of the type of fat consumed . However , the use of a dietary model rich in SFA creates a more procoagulant environment than does a model that includes MUFA or CHO/N3 as the source of fatty acids",
"The effects of a low-fat , carbohydrate-rich and a high-fat , olive-oil-rich diet on blood pressure were studied under strict dietary control . Forty-seven healthy normotensive men and women were fed a diet high in saturated fatty acids ( 20 en% ) and total fat ( 38 en% ) for 17 d. Twenty-four subjects then received a low-fat , carbohydrate-rich diet ( total fat 22 en% ) and the other 23 a high-fat , olive-oil-rich diet ( oleic acid 24 en% , total fat 41 en% ) for 36 d. Both test diets had the same level of saturated fatty acids ( 7 - 10 en% ) and linoleic acid ( 4 en% ) . Systolic blood pressure fell by 2.3 and diastolic by 4.7 mm Hg in the carbohydrate group and by 2.7 and 4.4 mm Hg in the olive-oil group , respectively ( differences between diets groups not significant ) . These results suggest that a high-fat diet rich in monounsaturated fatty acids has no deleterious effect on blood pressure in healthy normotensive subjects in comparison with a low-fat , carbohydrate-rich diet",
"Background —Although recent studies have indicated that nut consumption may improve levels of blood lipids , nuts are not generally recommended as snacks for hyperlipidemic subjects because of their high fat content . Furthermore , the effective dose is still unknown . Methods and Results —The dose-response effects of whole almonds , taken as snacks , were compared with low-saturated fat ( in the therapeutic diets of hyperlipidemic subjects . In a r and omized crossover study , 27 hyperlipidemic men and women consumed 3 isoenergetic ( mean 423 kcal/d ) supplements each for 1 month . Supplements provided 22.2 % of energy and consisted of full-dose almonds ( 73±3 g/d ) , half-dose almonds plus half-dose muffins , and full-dose muffins . Fasting blood , expired air , blood pressure , and body weight measurements were obtained at weeks 0 , 2 , and 4 . Mean body weights differed reduction in levels of blood lipids . Significant reductions from baseline were seen on both half- and full-dose almonds for LDL cholesterol ( 4.4±1.7 % , P = 0.018 , and 9.4±1.9 % , P and LDL : HDL cholesterol ( 7.8±2.2 % , P = 0.001 , and 12.0±2.1 % , P for lipoprotein(a ) ( 7.8±3.5 % , P = 0.034 ) and oxidized LDL concentrations ( 14.0±3.8 % , P seen in pulmonary nitric oxide between treatments . Conclusions —Almonds used as snacks in the diets of hyperlipidemic subjects significantly reduce coronary heart disease risk factors , probably in part because of the nonfat ( protein and fiber ) and monounsaturated fatty acid components of the nut",
"Background : It is uncertain whether saturated fatty acids ( SFAs ) impair endothelial function and contribute to arterial stiffening . Objective : We tested the effects of replacing SFAs with monounsaturated fatty acids ( MUFAs ) or carbohydrates on endothelial function and arterial stiffness . Design : With the use of a parallel- design ed r and omized controlled trial in 121 insulin-resistant men and women , we measured vascular function after 1 mo of consumption of a high-SFA ( HS ) diet and after 24 wk after r and om assignment to the HS diet or diets that contained The primary outcome was a change in flow-mediated dilation ( FMD ) , and secondary outcomes were changes in carotid to femoral pulse wave velocity ( PWV ) and plasma 8-isoprostane F2α-III concentrations . Results : For 112 participants with data available for analysis on the specified outcomes , no significant differences were shown . FMD with the HS reference diet was 6.7 ± 2.2 % , and changes ( 95 % CIs ) after 6 mo of intervention were + 0.3 ( −0.4 , 1.1 ) , −0.2 ( −0.8 , 0.5 ) , and −0.1 ( −0.6 , 0.7 ) with HS , high-MUFA ( HM ) , and high-carbohydrate ( HC ) diets , respectively . After consumption of the HS reference diet , the geometric mean ( ±SD ) PWV was 7.67 ± 1.62 m/s , and mean percentages of changes ( 95 % CIs ) were −1.0 ( −6.2 , 4.3 ) with the HS diet , 2.7 ( −1.4 , 6.9 ) with the HM diet , and −1.0 ( −5.5 , 3.4 ) with the HC diet . With the HS reference diet , the geometric mean ( ±SD ) plasma 8-isoprostane F2α-III concentration was 176 ± 85 pmol/L , and mean percentage of changes ( 95 % CIs ) were 1 ( −12 , 14 ) with the HS diet , 6 ( −5 , 16 ) with the HM diet , and 4 ( −7 , 16 ) with the HC diet . Conclusion : The replacement of SFAs with MUFAs or carbohydrates in healthy subjects does not affect vascular function . This trial was registered at Current Controlled Trials ( http://www.controlled-trials.com/IS RCT N ) as IS RCT N 29111298",
"A currently ongoing r and omized trial has revealed that the Mediterranean diet , rich in virgin olive oil or nuts , reduces systolic blood pressure in high-risk cardiovascular patients . Here , we present a structural sub study to assess the effect of a Mediterranean-style diet supplemented with nuts or virgin olive oil on erythrocyte membrane properties in 36 hypertensive participants after 1 year of intervention . Erythrocyte membrane lipid composition , structural properties of reconstituted erythrocyte membranes , and serum concentrations of inflammatory markers are reported . After the intervention , the membrane cholesterol content decreased , whereas that of phospholipids increased in all of the dietary groups ; the diminishing cholesterol : phospholipid ratio could be associated with an increase in the membrane fluidity . Moreover , reconstituted membranes from the nuts and virgin olive oil groups showed a higher propensity to form a nonlamellar inverted hexagonal phase structure that was related to an increase in phosphatidylethanolamine lipid class . These data suggest that the Mediterranean-style diet affects the lipid metabolism that is altered in hypertensive patients , influencing the structural membrane properties . The erythrocyte membrane modulation described provides insight in the structural bases underlying the beneficial effect of a Mediterranean-style diet in hypertensive subjects",
"Context Some experts attribute a low incidence of heart disease in Mediterranean countries to dietary habits . Contribution In this multicenter , 3-group trial , investigators r and omly assigned 772 adults at high risk for cardiovascular disease to a low-fat diet or to a Mediterranean diet supplemented with either virgin olive oil ( 1 L per week ) or nuts ( 30 g per day ) . After 3 months , the Mediterranean diet groups had lower mean plasma glucose level , systolic blood pressure , and total cholesterolhigh-density lipoprotein cholesterol ratio than the low-fat diet group . Caution s The Mediterranean diet groups received more nutritional education than the low-fat diet group . Implication s Mediterranean diets supplemented with olive oil or nuts may improve cardiovascular risk factors . The Editors Cardiovascular disease is the main cause of death in industrialized countries , but incidence rates have marked geographic differences . The low incidence of coronary heart disease ( CHD ) in Mediterranean countries has been partly ascribed to dietary habits ( 1 - 3 ) . Recent findings from large European cohort studies ( 4 - 6 ) suggest that a high degree of adherence to the Mediterranean diet is associated with a reduction in mortality . In small clinical studies , the Mediterranean diet or some of its components have reduced blood pressure ( 7 ) and have improved lipid profiles ( 8 , 9 ) and endothelial function ( 10 ) . Moreover , a recent cross-sectional study ( 11 ) and a 2-year feeding trial ( 12 ) have shown that adherence to the Mediterranean diet is associated with reduced markers of vascular inflammation . These beneficial effects on surrogate markers of cardiovascular risk add biological plausibility to the epidemiologic evidence that supports a protective effect of the Mediterranean diet . Olive oil , a rich source of monounsaturated fatty acids , is a main component of the Mediterranean diet . Virgin olive oil retains all the lipophilic components of the fruit , -tocopherol , and phenolic compounds with strong antioxidant and anti-inflammatory properties ( 13 , 14 ) . Tree nuts , which are also typical in the Mediterranean diet , have a favorable fatty acid profile and are a rich source of nutrients and other bioactive compounds that may beneficially influence the risk for CHD , such as fiber , phytosterols , folic acid , and antioxidants ( 15 ) . Frequent nut intake has been associated with decreased CHD rates in prospect i ve studies ( 15 ) . Walnuts differ from all other nuts through their high content of polyunsaturated fatty acids , particularly -linolenic acid , a plant n-3 fatty acid ( 16 ) , which may confer additional antiatherogenic properties ( 17 ) . Therefore , we design ed a large-scale feeding trial in high-risk participants to assess the effects of 2 Mediterranean diets , one supplemented with virgin olive oil and the other supplemented with mixed nuts , compared with a low-fat diet on cardiovascular outcomes . We report the results of a 3-month intervention on intermediate markers of cardiovascular risk in the first 772 participants who were recruited into the trial . Supplement . Original Version ( PDF ) Methods Study Design The Prevencin con Dieta Mediterrnea ( PREDIMED ) Study is a large , parallel-group , multicenter , r and omized , controlled , 4-year clinical trial that aims to assess the effects of the Mediterranean diet on the primary prevention of cardiovascular disease ( www.predimed.org ) . An estimated 9000 high-risk participants ( > 5000 participants are already recruited ) will be assigned to 3 interventions : Mediterranean diet with virgin olive oil , Mediterranean diet with mixed nuts , or low-fat diet . The main outcome is an aggregate of cardiovascular events ( cardiovascular death , nonfatal myocardial infa rct ion , or nonfatal stroke ) . The anticipated completion date of the trial is December 2010 . We design ed our present study to assess the 3-month effects of the dietary interventions on surrogate markers of cardiovascular risk in participants entering the study during the first 6 months of recruitment . The institutional review boards of the 10 participating centers approved the study protocol . Participants and Recruitment From October 2003 to March 2004 , we selected 930 potential participants in primary care centers affiliated with 10 teaching hospitals across Spain . Eligible participants were community-dwelling men , 55 to 80 years of age , and women , 60 to 80 years of age , who fulfilled at least 1 of 2 criteria : type 2 diabetes or 3 or more CHD risk factors ( current smoking , hypertension [ blood pressure > 140/90 mm Hg or treatment with antihypertensive drugs ] , low-density lipoprotein [ LDL ] cholesterol level 4.14 mmol/L [ 160 mg/dL ] [ or treatment with hypolipidemic drugs ] , high-density lipoprotein [ HDL ] cholesterol level 1.04 mmol/L [ 40 mg/dL ] , body mass index [ BMI ] 25 kg/m2 , or a family history of premature CHD ) . Exclusion criteria were history of cardiovascular disease , any severe chronic illness , drug or alcohol addiction , history of allergy or intolerance to olive oil or nuts , or low predicted likelihood of changing dietary habits according to the stages-of-change model ( 18 ) . The primary care physicians based participants ' eligibility on review of clinical records and a screening visit . They obtained a list of c and i date s from computer-based records of patients who attended each participating center and review ed their clinical records to exclude those who did not meet eligibility criteria . They then invited suitable c and i date s by telephone to attend a screening visit . The visit included an interview with administration of a 26-item question naire to inquire about medical conditions and risk factors related to eligibility . Of the eligible c and i date s who met entry requirements , 95 % agreed to participate and provided informed consent . R and omization and Intervention After the screening visit , each center r and omly assigned eligible participants to 1 of 3 diet groups by using a computer-generated r and om-number sequence . The coordinating center constructed the r and omization table , and participants were r and omly assigned into blocks of 50 participants balanced by center , sex , and age group ( . We concealed allocation into the intervention groups by using closed envelopes with correlative numbers by prespecified subgroups of sex and age . The baseline examination included the administration of a 14-item question naire , an extension of a previously vali date d question naire ( 19 ) , that assessed the degree of adherence to the traditional Mediterranean diet . We assigned values of 0 or 1 to each item ( Appendix Table 1 ) . We also administered a 137-item vali date d food frequency question naire ( 20 ) ; the vali date d Spanish version ( 21 ) of the Minnesota Leisure Time Physical Activity Question naire ; and a 47-item question naire about education , lifestyle , history of illnesses , and medication use . We performed anthropometric and blood pressure measurements and obtained sample s of fasting blood and spot urine . We repeated all examinations at 3 months . The same dietitian delivered the interventions to the 3 r and omized groups in each center . On the basis of the assessment of individual Mediterranean diet scores , the dietitian gave personalized dietary advice during a 30-minute session to each participant , with recommendations on the desired frequency of intake of specific foods . We advised participants who were allocated to the low-fat diet to reduce intake of all types of fat , and we gave them a leaflet with written recommendations according to the American Heart Association guidelines ( 22 ) . For total fat intake , these recommendations were opposite to those given to participants in the 2 Mediterranean diet groups , who received instructions intended to increase the 14-item Mediterranean diet score , including increased consumption of vegetable fats and oils . We did not suggest any energy restriction . While the participants who were allocated to the low-fat diet did not receive further intervention , those assigned the 2 Mediterranean diet groups had access to more intense intervention in 2 ways . First , they were given a free provision of typical Mediterranean fatty foods ( olive oil or nuts ) . Depending on group assignment , participants were given either free virgin olive oil ( 15 L [ 1 L/wk ] for 3 months ) or free sachets of walnuts , hazelnuts , and almonds ( 1350 g of walnuts [ 15 g/d ] , 675 g of hazelnuts [ 7.5 g/d ] , and 675 g of almonds [ 7.5 g/d ] for 3 months ) . To improve adherence and account for family needs , participants in the corresponding Mediterranean diet groups were given excess olive oil or additional 1000-g packets of nuts . We analyzed the nutrient composition of the olive oil and nuts used in the study by st and ard methods in a reference laboratory ( Appendix Table 2 ) ) . Second , 1 week after inclusion , the dietitian delivered a 1-hour group session with up to 20 participants , with separate sessions for each Mediterranean diet group . Each group session consisted of informative talks and provision of written material s with elaborate descriptions of typical Mediterranean foods and seasonal shopping lists , meal plans , and cooking recipes . Throughout the study , all participants had free and continuous access to their center dietitian for advice and consultation . Measurements Trained personnel measured weight and height by using calibrated scales and a wall-mounted stadiometer , respectively ; waist circumference midway between the lowest rib and the iliac crest by using an anthropometric tape ; and blood pressure in triplicate with a vali date d semiautomatic oscillometer ( Omron HEM-705CP , Hoofddorp , the Netherl and s ) . We calculated energy and nutrient intake from Spanish food composition tables ( 23 ) . At the 3-month visit and when consulted by participants , dietitians assessed any adverse effects from the interventions by administering a checklist of symptoms and gave advice on how to remedy them . The checklist included mouth symptoms ; bloating , fullness , or indigestion ; altered bowel",
"Background —Postpr and ial hypertriglyceridemia and hyperglycemia are considered risk factors for cardiovascular disease . Evidence suggests that postpr and ial hypertriglyceridemia and hyperglycemia induce endothelial dysfunction through oxidative stress ; however , the distinct role of these two factors is a matter of debate . Methods and Results —Thirty type 2 diabetic patients and 20 normal subjects ate 3 different meals : a high-fat meal ; 75 g glucose alone ; and high-fat meal plus glucose . Glycemia , triglyceridemia , nitrotyrosine , and endothelial function were assayed during the tests . Subsequently , diabetics took 40 mg/d simvastatin or placebo for 12 weeks . The 3 tests were performed again at baseline , between 3 to 6 days after the start , and at the end of each study . High-fat load and glucose alone produced a decrease of endothelial function and an increase of nitrotyrosine in normal and diabetic subjects . These effects were more pronounced when high fat and glucose were combined . Short-term simvastatin treatment had no effect on lipid parameters but reduced the effect on endothelial function and nitrotyrosine observed during each different test . Long-term simvastatin treatment was accompanied by a lower increase in postpr and ial triglycerides , which was followed by smaller variations of endothelial function and nitrotyrosine during the tests . Conclusions —This study shows an independent and cumulative effect of postpr and ial hypertriglyceridemia and hyperglycemia on endothelial function , suggesting oxidative stress as common mediator of such effect . Simvastatin shows a beneficial effect on oxidative stress and endothelial dysfunction , which may be ascribed to a direct effect as well as the lipid-lowering action of the drug",
"OBJECTIVE To compare the effects of a eucaloric diet higher in carbohydrate/lower in fat versus lower in carbohydrate/higher in monounsaturated fat on postmeal triglyceride ( TG ) concentrations and other cardiovascular disease risk factors in nonobese subjects with type 1 diabetes and in good glycemic control . RESEARCH DESIGN AND METHODS In a parallel group design study , 30 subjects were r and omly assigned and completed one of the two eucaloric diets . Assessment s included : BMI , blood pressure , A1C , plasma lipids , and markers of oxidation , thrombosis , and inflammation . At 6 months , subjects were hospitalized for 24 h to measure plasma TG excursions . RESULTS There were no significant differences between groups other than decreased plasminogen activator inhibitor 1 ( PAI-1 ) levels and weight gain in the lower-carbohydrate/higher – monounsaturated fat group . During the 24-h testing , the lower-carbohydrate/higher – monounsaturated fat group had a lower plasma TG profile . CONCLUSIONS A diet lower in carbohydrate/higher in monounsaturated fat could offer an appropriate choice for nonobese type 1 diabetic individuals with good metabolic and weight control ",
"We compared the effects on blood pressure ( BP ) of three isocaloric diets with reduced total fat and saturated fatty acid ( SAFA ) contents but with different proportions of monounsaturated ( MUFA ) and polyunsaturated fatty acids ( PUFA ) . Diet LF ( low fat ) provided 20 en% fat ( 7.9 % SAFA , 7.8 % MUFA , 3.0 % PUFA ) ; diet HP ( high PUFA ) 26 en% fat ( 7.5 % SAFA , 8.2 % MUFA , 8.1 % PUFA ) , and diet HM ( high MUFA ) 26 en% fat ( 7.3 % SAFA , 14.1 % MUFA , 3.2 % PUFA ) . The diets were consumed for 8 weeks ( intervention ) preceded by 2 weeks and followed by 8 weeks on a habitual diet ( baseline/ switchback ) with 33–34 en% fat ( 13–14 % SAFA , 12 % MUFA , 6 % PUFA ) . Forty-five free-living couples were r and omly allocated into the three diet groups , and 43 men and 44 women completed the study . BP was measured weekly with an automatic device . Compliance to diet was monitored by repeated food records , serum fatty acid compositions , and weekly visits to a nutritionist . Both systolic BP ( SBP ) and diastolic BP ( DBP ) remained unchanged throughout the study in all three groups . The weight-adjusted mean ( s.e.m . ) BP values showed changes in SBP of + 1.7 ( 1.8 ) , −0.4 ( 1.7 ) , and + 1.9 ( 1.9 ) mm Hg on the LF , HP , and HM diets , respectively ( difference NS ) , and DBP of + 0.1 ( 1.0 ) , + 0.6 ( 1.0 ) , and −0.3 ( 1.0 ) mm Hg , respectively ( difference NS ) between the last 2 weeks of the baseline and intervention periods . The expected fatty acid intakes were achieved , and there were no between-group differences in change of body weight , intake of dietary fibre and potassium , and 24-h sodium excretion . A reduction in total fat and SAFA intake and changes in the proportions of dietary MUFA and PUFA did not affect the BP levels of this normotensive population with an adequate intake of PUFA at baseline",
"OBJECTIVE To compare concentrations of factor VII coagulant activity ( factor VIIc ) , fibrinogen , plasminogen activator inhibitor-1 , and blood lipids on a saturated fat-rich diet with one rich in monounsaturated fat . DESIGN Subjects were r and omly allocated to two groups . The study design was an ABB/BAA extra-period crossover . One group consumed a diet rich in saturated fatty acid ( SFA ) with fat making up 20.8 % of total energy , for 5 weeks and then one rich in monounsaturated fatty acid ( MUFA ) , with fat making up 20.3 % of total energy for 10 weeks . The other group consumed the MUFA diet for 5 weeks followed by the SFA diet for 10 weeks . SUBJECTS/ SETTING Men and women aged 35 to 69 years who were nonsmokers with no chronic illness and not on any medication were recruited to participate . Eighteen subjects were recruited and 15 ( 5 men , 10 women ) completed the community-based study . INTERVENTION Blood was sample d at the beginning and end point of each 5-week diet period for analysis of coagulation and fibrinolysis factors and blood lipids . Subjects kept 3-day food diaries twice during each of the three diet periods and were weighed on each visit for blood collection . Analysis of plasma fatty acids was used to indicate dietary compliance . MAIN OUTCOME MEASURES Differences in fasting factor VIIc , fibrinogen , plasminogen activator inhibitor-1 , insulin , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , triglycerides , apolipoproteins A-1 and B , and plasma oleic acid levels while receiving the SFA diet vs MUFA diet . STATISTICAL ANALYSIS A general linear model allowing for the ABB/BAA extra-period crossover , was used for each of the outcome measures . RESULTS Factor VIIc was lower on the MUFA diet ( P fibrinogen and insulin concentrations and plasminogen activator inhibitor-1 activity did not differ between diets . Low-density lipoprotein cholesterol ( P triglyceride ( P . A significant increase in both plasma phospholipid and neutral lipid oleic acid ( P blood lipids and factor VIIc . This oil presents another useful source of MUFA for diets aim ed at prevention of heart disease",
"OBJECTIVE To examine the effects of a high-carbohydrate low-fat ( HCLF ) and a modified-fat ( MF ) diet on body weight and metabolic control in subjects with non-insulin-dependent diabetes mellitus ( NIDDM ) living at home . RESEARCH DESIGN AND METHODS Twenty-four NIDDM patients followed HCLF and MF diets alternately and in r and om order for a 3-month period while at home , with a 1-month baseline and washout between diets . Before and after each diet , fasting glucose and lipids , HbAlc , blood pressure , and body weight were measured . Dietary preferences were assessed by question naire . RESULTS Subjects consumed 50 % of energy as carbohydrate and 23 % as fat on the HCLF diet and 40 % of energy as carbohydrate and 36 % as fat ( over half of which was monounsaturated fat ) on the MF diet . Subjects lost weight on both HCLF and MF diets ( mean loss 0.7 and 1.3 kg , respectively ) . Although the MF diet result ed in a small decrease in fasting glucose levels , there was no significant change in HbA1c . Similarly , there was no significant difference between the diets in changes in blood pressure or fasting blood lipids . Most subjects ( 65 % ) preferred the MF diet . CONCLUSIONS Although the MF diet is not a low-fat diet , it did not appear to facilitate weight gain in subjects with NIDDM living at home . The MF diet provides an alternative for individuals unable to comply with HCLF diets",
"OBJECTIVE To compare the influence on blood pressure , glucose , and lipid levels of a diet rich in monounsaturated fatty acids with an isocaloric , highcarbohydrate diet in 15 NIDDM subjects . RESEARCH DESIGN AND METHODS A crossover design with diet interventions and wash-out periods of 3 wk was applied . The patients were r and omly assigned to a 3-wk treatment with a high-carbohydrate diet containing 50 % of energy as carbohydrate and 30 % of energy as fat ( 10 % of energy as monounsaturated fatty acids ) or an isocaloric diet with 30 % of energy as carbohydrate and 50 % of energy as fat ( 30 % of energy as monounsaturated fatty acids ) . On the last day of the two diets , 24-h ambulatory blood pressure was measured and day profiles of glucose , hormones , and lipids were performed to a test menu rich in carbohydrates . RESULTS The diet rich in monounsaturated fat reduced daytime systolic ( 131 ± 3 vs. 137 ± 3 mmHg , P and 24-h systolic blood pressure ( 126 ± 8 vs. 130 ± 10 mmHg , P well as daytime diastolic ( 78 ± 2 vs. 84 ± 2 mmHg , P 0.02 ) and diurnal diastolic blood pressure ( 75 ± 6 vs. 78 ± 5 mmHg , P lowered blood glucose levels on the high-monounsaturated diet compared with the highcarbohydrate diet were found with lower fasting blood glucose ( 6.1 ± 0.3 vs. 6.8 ± 0.5 mM , P 0.05 ) , lower average blood glucose levels ( 7.4 ± 0.5 vs. 8.2 ± 0.6 mM , P responses ( 9.9 ± 0.6 vs. 11.3 ± 0.7 mM , P effects on blood pressure and glucose metabolism , whereas no adverse effects on lipid composition in NIDDM subjects is detected",
"OBJECTIVE To investigate whether blood pressure is different in type 2 diabetic patients on a diet rich in carbohydrates versus a diet rich in cis-monounsaturated fatty acids . Data on the dietary effects on these diets ' glucose and lipid metabolism have been previously published . RESEARCH DESIGN AND METHODS The study compared the effect of feeding 42 type 2 diabetic patients a carefully controlled isoenergic high-carbohydrate ( high-carb ; 55 % energy as carbohydrate , 30 % as fat , and 10 % as monounsaturated fat ) and high-monounsaturated fat ( high-mono ; 45 % energy as fat , 25 % as monounsaturated fat , and 40 % as carbohydrate ) diet for 6 weeks each in a four-center , r and omized , cross-over study on blood pressure . Twenty-one patients continued the diet they received during the second phase for an additional 8 weeks . RESULTS According to repeated- measures ANOVA , blood pressure during the last 3 days of each phase was similar after 6 weeks of the high-carb and high-mono diets ( systolic blood pressure : 128 + /- 16 vs. 127 + /- 15 mmHg , P = 0.9 ; diastolic blood pressure : 75 + /- 7 vs. 75 + /- 8 mmHg , P = 0.7 ) . However , after 14 weeks of the high-carb diet ( n = 13 ) , there was a significant increase in blood pressure compared with 6 weeks of the high-mono diet ( systolic blood pressure : 132 + /- 13 vs. 126 + /- 11 mmHg , P = 0.04 ; diastolic blood pressure : 83 + /- 6 vs. 76 + /- 7 mmHg , P = 0.002 ) . After 14 weeks of the high-mono diet ( n = 8) , the reduction in blood pressure was not significant compared with 6 weeks of the high-carb diet ( systolic blood pressure : 118 + /- 14 vs. 121 + /- 16 mmHg , P = 0.4 ; diastolic blood pressure : 71 + /- 8 vs. 75 + /- 10 mmHg , P = 0.3 ) . CONCLUSION Although the exchange of carbohydrates with monounsaturated fats may not affect blood pressure in the short term , long-term consumption of a high-carbohydrate diet may modestly raise blood pressure in type 2 diabetic patients",
"BACKGROUND Public health strategies to lower cardiovascular disease ( CVD ) risk involve reducing dietary saturated fatty acid ( SFA ) intake to ≤10 % of total energy ( % TE ) . However , the optimal type of replacement fat is unclear . OBJECTIVE We investigated the substitution of 9.5 - 9.6%TE dietary SFAs with either monounsaturated fatty acids ( MUFAs ) or n-6 ( ω-6 ) polyunsaturated fatty acids ( PUFAs ) on vascular function and other CVD risk factors . DESIGN In a r and omized , controlled , single-blind , parallel-group dietary intervention , 195 men and women aged 21 - 60 y from the United Kingdom with moderate CVD risk ( ≥50 % above the population mean ) followed one of three 16-wk isoenergetic diets ( % TE target compositions , total fat : SFA : MUFA : n-6 PUFA ) that were rich in SFAs ( 36:17:11:4 , n = 65 ) , MUFAs ( 36:9:19:4 , n = 64 ) , or n-6 PUFAs ( 36:9:13:10 , n = 66 ) . The primary outcome measure was flow-mediated dilatation ; secondary outcome measures included fasting serum lipids , microvascular reactivity , arterial stiffness , ambulatory blood pressure , and markers of insulin resistance , inflammation , and endothelial activation . RESULTS Replacing SFAs with MUFAs or n-6 PUFAs did not affect the percentage of flow-mediated dilatation ( primary endpoint ) or other measures of vascular reactivity . Of the secondary outcome measures , substitution of SFAs with MUFAs attenuated the increase in night systolic blood pressure ( -4.9 mm Hg , P = 0.019 ) and reduced E-selectin ( -7.8 % , P = 0.012 ) . Replacement with MUFAs or n-6 PUFAs lowered fasting serum total cholesterol ( -8.4 % and -9.2 % , respectively ) , low-density lipoprotein cholesterol ( -11.3 % and -13.6 % ) , and total cholesterol to high-density lipoprotein cholesterol ratio ( -5.6 % and -8.5 % ) ( P ≤ 0.001 ) . These changes in low-density lipoprotein cholesterol equate to an estimated 17 - 20 % reduction in CVD mortality . CONCLUSIONS Substitution of 9.5 - 9.6%TE dietary SFAs with either MUFAs or n-6 PUFAs did not significantly affect the percentage of flow-mediated dilatation or other measures of vascular function . However , the beneficial effects on serum lipid biomarkers , blood pressure , and E-selectin offer a potential public health strategy for CVD risk reduction . This trial was registered at www . clinical trials.gov as NCT01478958",
"BACKGROUND The relationship between macronutrients and cardiovascular disease and mortality is controversial . Most available data are from European and North American population s where nutrition excess is more likely , so their applicability to other population s is unclear . METHODS The Prospect i ve Urban Rural Epidemiology ( PURE ) study is a large , epidemiological cohort study of individuals aged 35 - 70 years ( enrolled between Jan 1 , 2003 , and March 31 , 2013 ) in 18 countries with a median follow-up of 7·4 years ( IQR 5·3 - 9·3 ) . Dietary intake of 135 335 individuals was recorded using vali date d food frequency question naires . The primary outcomes were total mortality and major cardiovascular events ( fatal cardiovascular disease , non-fatal myocardial infa rct ion , stroke , and heart failure ) . Secondary outcomes were all myocardial infa rct ions , stroke , cardiovascular disease mortality , and non-cardiovascular disease mortality . Participants were categorised into quintiles of nutrient intake ( carbohydrate , fats , and protein ) based on percentage of energy provided by nutrients . We assessed the associations between consumption of carbohydrate , total fat , and each type of fat with cardiovascular disease and total mortality . We calculated hazard ratios ( HRs ) using a multivariable Cox frailty model with r and om intercepts to account for centre clustering . FINDINGS During follow-up , we documented 5796 deaths and 4784 major cardiovascular disease events . Higher carbohydrate intake was associated with an increased risk of total mortality ( highest [ quintile 5 ] vs lowest quintile [ quintile 1 ] category , HR 1·28 [ 95 % CI 1·12 - 1·46 ] , ptrend=0·0001 ) but not with the risk of cardiovascular disease or cardiovascular disease mortality . Intake of total fat and each type of fat was associated with lower risk of total mortality ( quintile 5 vs quintile 1 , total fat : HR 0·77 [ 95 % CI 0·67 - 0·87 ] , ptrend ) . Higher saturated fat intake was associated with lower risk of stroke ( quintile 5 vs quintile 1 , HR 0·79 [ 95 % CI 0·64 - 0·98 ] , ptrend=0·0498 ) . Total fat and saturated and unsaturated fats were not significantly associated with risk of myocardial infa rct ion or cardiovascular disease mortality . INTERPRETATION High carbohydrate intake was associated with higher risk of total mortality , whereas total fat and individual types of fat were related to lower total mortality . Total fat and types of fat were not associated with cardiovascular disease , myocardial infa rct ion , or cardiovascular disease mortality , whereas saturated fat had an inverse association with stroke . Global dietary guidelines should be reconsidered in light of these findings . FUNDING Full funding sources listed at the end of the paper ( see Acknowledgments )",
"Objectives : To examine the effect of dietary lipid modification on 24-h ambulatory blood pressure , cardiovascular reactivity and sympathetic activity in man Design : Twenty-four normal volunteers consumed either a high-fat or a low-fat diet for 2 weeks in an open , r and omized , crossover study of duration 6 weeks . Diets were isocaloric and balanced for sodium and potassium content Methods : Cardiovascular reactivity was assessed by measurement of blood pressure responses to incremental infusions of angiotensin II and noradrenaline , and to sympathetic reflex testing . Plasma noradrenaline spillover and clearance rates were estimated using [3H]-noradrenaline infusion Results : Total plasma cholesterol and low-density lipoprotein-cholesterol levels both fell significantly on the low-fat compared with the high-fat diet , as did heart rate and mean arterial pressure ( recorded by 24-h ambulatory monitoring ) . These changes were accompanied by reductions in blood pressure responses to cold pressor testing and to noradrenaline infusion on the low-fat diet . Plasma noradrenaline spillover and clearance rates did not change . Post hoc analysis showed an association between oral contraceptive use and increased noradrenaline sensitivity on the high-fat diet among the females tested . Conclusion : Dietary fat intake alters heart rate , blood pressure and cardiovascular reactivity to noradrenaline in man without changes in basal noradrenaline metabolism",
"ABCD : Appropriate Blood pressure Control in Diabetes ABI : ankle – brachial index ABPM : ambulatory blood pressure monitoring ACCESS : Acute C and esartan Cilexetil Therapy in Stroke Survival ACCOMPLISH : Avoiding Cardiovascular Events in Combination Therapy in Patients Living with Systolic Hypertension ACCORD : Action to Control Cardiovascular Risk in Diabetes ACE : angiotensin-converting enzyme ACTIVE I : Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events ADVANCE : Action in Diabetes and Vascular Disease : Preterax and Diamicron-MR Controlled Evaluation AHEAD : Action for HEAlth in Diabetes ALLHAT : Antihypertensive and Lipid-Lowering Treatment to Prevent Heart ATtack ALTITUDE : ALiskiren Trial In Type 2 Diabetes Using Cardio-renal Endpoints ANTIPAF : ANgioTensin II Antagonist In Paroxysmal Atrial Fibrillation APOLLO : A R and omized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People ARB : angiotensin receptor blocker ARIC : Atherosclerosis Risk In Communities ARR : aldosterone renin ratio ASCOT : Anglo-Sc and inavian Cardiac Outcomes Trial ASCOT-LLA : Anglo-Sc and inavian Cardiac Outcomes Trial — Lipid Lowering Arm ASTRAL : Angioplasty and STenting for Renal Artery Lesions A-V : atrioventricular BB : beta-blocker BMI : body mass index BP : blood pressure BSA : body surface area CA : calcium antagonist CABG : coronary artery bypass graft CAPPP : CAPtopril Prevention Project CAPRAF : C And esartan in the Prevention of Relapsing Atrial Fibrillation CHD : coronary heart disease CHHIPS : Controlling Hypertension and Hypertension Immediately Post-Stroke CKD : chronic kidney disease CKD-EPI : Chronic Kidney Disease — EPIdemiology collaboration CONVINCE : Controlled ONset Verapamil INvestigation of CV Endpoints CT : computed tomography CV : cardiovascular CVD : cardiovascular disease D : diuretic DASH : Dietary Approaches to Stop Hypertension DBP : diastolic blood pressure DCCT : Diabetes Control and Complications Study DIRECT : DIabetic REtinopathy C and esartan Trials DM : diabetes mellitus DPP-4 : dipeptidyl peptidase 4 EAS : European Atherosclerosis Society EASD : European Association for the Study of Diabetes ECG : electrocardiogram EF : ejection fraction eGFR : estimated glomerular filtration rate ELSA : European Lacidipine Study on Atherosclerosis ESC : European Society of Cardiology ESH : European Society of Hypertension ESRD : end-stage renal disease EXPLOR : Amlodipine – Valsartan Combination Decreases Central Systolic Blood Pressure more Effectively than the Amlodipine – Atenolol Combination FDA : U.S. Food and Drug Administration FEVER : Felodipine EVent Reduction study GISSI-AF : Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-Atrial Fibrillation HbA1c : glycated haemoglobin HBPM : home blood pressure monitoring HOPE : Heart Outcomes Prevention Evaluation HOT : Hypertension Optimal Treatment HRT : hormone replacement therapy HT : hypertension HYVET : HYpertension in the Very Elderly Trial IMT : intima-media thickness I-PRESERVE : Irbesartan in Heart Failure with Preserved Systolic Function INTERHEART : Effect of Potentially Modifiable Risk Factors associated with Myocardial Infa rct ion in 52 Countries INVEST : INternational VErapamil SR/T Tr and olapril ISH : Isolated systolic hypertension JNC : Joint National Committee JUPITER : Justification for the Use of Statins in Primary Prevention : an Intervention Trial Evaluating Rosuvastatin LAVi : left atrial volume index LIFE : Losartan Intervention For Endpoint Reduction in Hypertensives LV : left ventricle/left ventricular LVH : left ventricular hypertrophy LVM : left ventricular mass MDRD : Modification of Diet in Renal Disease MRFIT : Multiple Risk Factor Intervention Trial MRI : magnetic resonance imaging NORDIL : The Nordic Diltiazem Intervention study OC : oral contraceptive OD : organ damage ONTARGET : ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial PAD : peripheral artery disease PATHS : Prevention And Treatment of Hypertension Study PCI : percutaneous coronary intervention PPAR : peroxisome proliferator-activated receptor PREVEND : Prevention of REnal and Vascular ENdstage Disease PROFESS : Prevention Regimen for Effectively Avoiding Secondary Strokes PROGRESS : Perindopril Protection Against Recurrent Stroke Study PWV : pulse wave velocity QALY : Quality adjusted life years RAA : renin-angiotensin-aldosterone RAS : renin-angiotensin system RCT : r and omized controlled trials RF : risk factor ROADMAP : R and omized Olmesartan And Diabetes MicroAlbuminuria Prevention SBP : systolic blood pressure SCAST : Angiotensin-Receptor Blocker C and esartan for Treatment of Acute STroke SCOPE : Study on COgnition and Prognosis in the Elderly SCORE : Systematic COronary Risk Evaluation SHEP : Systolic Hypertension in the Elderly Program STOP : Swedish Trials in Old Patients with Hypertension STOP-2 : The second Swedish Trial in Old Patients with Hypertension SYSTCHINA : SYSTolic Hypertension in the Elderly : Chinese trial SYSTEUR : SYSTolic Hypertension in Europe TIA : transient ischaemic attack TOHP : Trials Of Hypertension Prevention TRANSCEND : Telmisartan R and omised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease UKPDS : United Kingdom Prospect i ve Diabetes Study VADT : Veterans ' Affairs Diabetes Trial VALUE : Valsartan Antihypertensive Long-term Use Evaluation WHO : World Health Organization # # # 1.1 Principles The 2013 guidelines on hypertension of the European Society of Hypertension ( ESH ) and the European Society of Cardiology",
"BACKGROUND & AIMS Non-alcoholic fatty liver disease ( NAFLD ) affects up to 30 % of the population and signifies increased risk of liver fibrosis and cirrhosis , type 2 diabetes , and cardiovascular disease . Therapies are limited . Weight loss is of benefit but is difficult to maintain . We aim ed at examining the effect of the Mediterranean diet ( MD ) , a diet high in monounsaturated fatty acids , on steatosis and insulin sensitivity , using gold st and ard techniques . METHODS Twelve non-diabetic subjects ( 6 Females/6 Males ) with biopsy-proven NAFLD were recruited for a r and omised , cross-over 6-week dietary intervention study . All subjects undertook both the MD and a control diet , a low fat-high carbohydrate diet ( LF/HCD ) , in r and om order with a 6-week wash-out period in- between . Insulin sensitivity was determined with a 3-h hyperinsulinemic-euglycemic clamp study and hepatic steatosis was assessed with localized magnetic resonance (1)H spectroscopy ( (1)H-MRS ) . RESULTS At baseline , subjects were abdominally obese with elevated fasting concentrations of glucose , insulin , triglycerides , ALT , and GGT . Insulin sensitivity at baseline was low ( M=2.7 ± 1.0 mg/kg/min(-1 ) ) . Mean weight loss was not different between the two diets ( p=0.22 ) . There was a significant relative reduction in hepatic steatosis after the MD compared with the LF/HCD : 39 ± 4 % versus 7 ± 3 % , as measured by (1)H-MRS ( p=0.012 ) . Insulin sensitivity improved with the MD , whereas after the LF/HCD there was no change ( p=0.03 between diets ) . CONCLUSIONS Even without weight loss , MD reduces liver steatosis and improves insulin sensitivity in an insulin-resistant population with NAFLD , compared to current dietary advice . This diet should be further investigated in subjects with NAFLD"
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A systematic review was undertaken to examine all available evidence to develop and support clinical recommendations regarding the use of fulvestrant ( Faslodex ® ) as systemic therapy of locally advanced or metastatic breast cancer in postmenopausal women . MEDLINE , EMBASE , American Society of Clinical Oncology Annual Meeting proceedings , San Antonio Breast Cancer Symposia proceedings , and the Cochrane Library were search ed through to April of 2008 for reports of r and omized controlled trials that met established inclusion criteria . Four relevant Phase III trials were available for inclusion based on established criteria . Three of four Phase III superiority trials found no significant difference between fulvestrant and control , either anastrozole or exemestane , across efficacy and safety endpoints following prior endocrine therapy failure , with two trials further confirming non-inferiority of fulvestrant to anastrozole retrospectively . Fulvestrant can therefore be considered as alternative therapy to anastrozole or exemestane in postmenopausal women with locally advanced or metastatic breast cancer that has recurred on prior adjuvant endocrine therapy or progressed on prior endocrine therapy for advanced disease . There are , however , important method ological concerns across review ed trials that should be taken under consideration as they may limit the strength of such a conclusion
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"The r and omized clinical trial ( RCT ) is the gold st and ard for definitive evaluation of new therapies . RCTs design ed to show that the therapeutic efficacy of a new therapy is not unacceptably inferior to that of st and ard therapy are called noninferiority trials . Traditionally , noninferiority trials have required very large sample sizes . Sometimes , a new treatment regimen with a favorable toxicity and /or tolerability profile is also expected to have some modest improvement in efficacy . In such specialized setting s we describe a hybrid trial- design approach that requires a dramatically smaller sample size than that of a st and ard noninferiority design . This hybrid design can naturally incorporate a formal test of superiority as well as noninferiority",
"Objective To characterise the pharmacokinetics of a long-acting formulation of fulvestrant following intramuscular administration of single and multiple doses . Study design : Pharmacokinetic investigations of single and multiple doses of fulvestrant were conducted within two global phase III efficacy studies that compared intramuscular fulvestrant with oral anastrozole in postmenopausal women with hormone-sensitive advanced breast cancer ( study 0020 , conducted in Europe , Australia and South Africa , and study 0021 , conducted in North America ) . Methods Patients received once-monthly intramuscular injections of fulvestrant 250 mg ( 1 × 5mL for ≤21 months in study 0020 ; 2 × 2.5mL for ≤30 months in study 0021 ) . Serial blood sample s were collected for the first 28 days after the initial dose and immediately prior to all subsequent monthly doses . Plasma fulvestrant concentrations were determined by high-performance liquid chromatography-t and em mass spectrometry . Patients Twenty-six ( study 0020 ) and 193 ( study 0021 ) postmenopausal women , comprising the pharmacokinetic subgroups of the phase III efficacy trials , were studied . Patients had shown disease progression or recurrence following previous hormonal therapy for advanced disease or had relapsed after adjuvant endocrine therapy with a nonsteroidal antiestrogen . Outcome measures and results For single-dose fulvestrant 250 mg , area under the concentration-time curve from time zero to 28 days ( AUC28 ) , maximum observed plasma concentration ( Cmax ) , minimum observed plasma concentration at 28 days ( Cmin ) and time to maximum plasma concentration ( tmax ) were determined . For multiple-dose fulvestrant 250 mg once monthly , steady-state trough concentrations ( Ctrough ) were determined . Plasma fulvestrant concentrations reached a peak at a median of 7 days ( range 2–8 days ) postdose , and declined biexponentially with a slower phase commencing approximately 2–3 weeks postdose . Intersubject variability in Cmax and AUC28 was approximately 6-fold and 4-fold , respectively . Mean parameters for single-dose fulvestrant were : AUC28 , 148 μg · day/L ; Cmax , 8.2 μg/L ; Cmin , 2.6 μg/L ; tmax , 7.0 days . Geometric mean Ctrough increased from 2.57 to 6.15 μg/L ( study 0020 ) and from 2.38 to 6.52 μg/L ( study 0021 ) over the first 6 months , reaching steady-state concentrations of approximately 6–7 μg/L ( study 0020 ) or 9 μg/L ( study 0021 ) . Preliminary pharmacokinetic analysis , using a naive pooled data approach , suggests that observed single- and multiple-dose plasma profiles can be adequately described with a two-compartment kinetic model . Model-generated steady-state AUC28 values were approximately 300 μg · day/L. Conclusions The intramuscular formulation of fulvestrant displays predictable kinetics and approximately 2-fold accumulation on administration once monthly . At the proposed therapeutic dosage ( 250 mg once monthly ) , plasma fulvestrant concentrations are maintained within a narrow range throughout the administration interval , thus ensuring stable systemic drug exposure during long-term treatment",
"737 Background : Fulvestrant ( Faslodex ) is an estrogen receptor antagonist with no agonist effects . Two phase III trials have compared the efficacy of fulvestrant 250 mg ( once-monthly , intramuscular injection ) and anastrozole ( 1 mg/daily , p.o . ) in patients with advanced breast cancer progressing on prior endocrine therapy . Fulvestrant was at least as effective as anastrozole for the primary endpoint of time to progression and the secondary endpoint of objective response ( OR ) . Here , we report a retrospective analysis of duration of response ( DOR ) by categorical time period ( ≥1 year ) in patients experiencing an OR ( complete [ CR ] or partial response [ PR ] ) or clinical benefit ( CB ; CR + PR + stable disease [ SD ] ≥24 weeks ) in these two trials . METHODS Duration of OR and CB was calculated from r and omization until disease progression and percentages were calculated using the total number of patients per treatment group as the denominator ( fulvestrant n=428 ; anastrozole n=423 ) . RESULTS Median follow-up was 22.1 months . A total of 186 patients receiving fulvestrant had CB ( CR : n=20 ; PR : n=62 ; SD ≥24 weeks : n=104 ) compared with 173 patients receiving anastrozole ( CR : n=11 ; PR : n=59 ; SD ≥24 weeks : n=103 ) . A numerically greater proportion of patients receiving fulvestrant achieved OR and CB for ≥1 year than those receiving anastrozole . CONCLUSION Fulvestrant has benefits in terms of the numbers of patients with prolonged duration of response . These data support the initial DOR findings in these trials . [ Figure : see text ] [ Table : see text ]",
"Abstract Purpose . This retrospective evaluation of data from two r and omized , multicenter trials examined whether tumor responses to further endocrine therapy were seen in postmenopausal women with advanced breast cancer who had progressed on both initial endocrine therapy , usually tamoxifen , and on the estrogen receptor ( ER ) antagonist fulvestrant ( ' Faslodex ' ) . Patients and methods . A combined total of 423 patients received fulvestrant 250 mg as a monthly intramuscular injection . After progression on fulvestrant , some patients received another endocrine therapy . Responses to subsequent endocrine therapy were assessed using a question naire sent to the trial investigators . Best responses were classified as a complete or partial response ( CR or PR ) , stable disease ( SD ) lasting ≥24 weeks , or disease progression . Results . Follow-up data were available for 54 patients who derived clinical benefit ( CB , defined as CR , PR or SD ) from fulvestrant and who received subsequent endocrine therapy , result ing in a PR in 4 patients , SD in 21 patients , and disease progression in 29 patients . Data were available for 51 patients who derived no CB from fulvestrant and who received further endocrine therapy , result ing in a PR in 1 patient , SD in 17 patients , and disease progression in 33 patients . Aromatase inhibitors were used as subsequent endocrine therapy in > 80 % of patients . Conclusions . After progression on fulvestrant , patients may retain sensitivity to other endocrine agents . Fulvestrant provides an additional option to existing endocrine therapies for the treatment of advanced or metastatic breast cancer in postmenopausal women , and may provide the opportunity to extend the sequence of endocrine regimens before cytotoxic chemotherapy is required",
"The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , including a checklist and a flow diagram , was developed to help authors improve their reporting of r and omized controlled trials . Its primary focus was on individually r and omized trials with 2 parallel groups that assess the possible superiority of one treatment compared with another but is now being extended to other trial design s. Noninferiority and equivalence trials have method ological features that differ from superiority trials and present particular difficulties in design , conduct , analysis , and interpretation . Although the rationale for such trials occurs frequently , those design ed and described specifically as noninferiority or equivalence trials appear less commonly in the medical literature . The quality of reporting of those that are published is often inadequate . In this article , we present an adapted CONSORT checklist for reporting noninferiority and equivalence trials and provide illustrative examples and explanations for those items amended from the original CONSORT checklist . The intent is to improve reporting of noninferiority and equivalence trials , enabling readers to assess the validity of their results and conclusions",
"The aim of this study was to compare the efficacy and tolerability of the new aromatase inhibitor ' ARIMIDEX ' ( anastrozole ) with megestrol acetate in the treatment of advanced breast cancer in postmenopausal women . Anastrozole is a new potent and highly selective non-steroidal aromatase inhibitor . We conducted a prospect i ve r and omised trial comparing two doses of anastrozole ( 1 and 10 mg orally once daily ) with megestrol acetate ( 40 mg orally four times daily ) in postmenopausal patients with advanced breast cancer who progressed after prior tamoxifen therapy . All patients were analysed for efficacy as r and omised ( intention to treat ) and for tolerability as per treatment received . Of the 378 patients who entered the study , 135 were r and omised to anastrozole 1 mg , 118 to anastrozole 10 mg , and 125 patients to megestrol acetate . After a median follow-up of 192 days , response rate which included complete response , partial response and patients who had disease stabilisation for 6 months or more was 34 % for anastrozole 1 mg , 33.9 % for anastrozole 10 mg and 32.8 % for megestrol acetate . There were no statistically significant differences between either dose of anastrozole and megestrol acetate in terms of objective response rate , time to objective progression of disease or time to treatment failure . The three treatments were generally well tolerated , but more patients on megestrol acetate reported weight gain , oedema and dyspnoea as adverse events while more patients on anastrozole reported gastro-intestinal disorders , usually in the form of mild transient nausea . Patients on anastrozole did not report higher incidences of oestrogen withdrawal symptoms . Anastrozole is an effective and well tolerated treatment for postmenopausal patients with advanced breast cancer . The higher 10 mg dose did not result in additional clinical benefit , but was well tolerated reflecting the good therapeutic margin with anastrozole . Based on this data , anastrozole 1 mg should be the recommended therapeutic dose",
"PURPOSE To compare the efficacy and tolerability of tamoxifen with that of letrozole , an oral aromatase inhibitor , with tamoxifen as first-line therapy in postmenopausal women with advanced breast cancer . PATIENTS AND METHODS Nine hundred seven patients were r and omly assigned letrozole 2.5 mg once daily ( 453 patients ) or tamoxifen 20 mg once daily ( 454 patients ) . Patients had estrogen receptor- and /or progesterone receptor-positive tumors , or both receptors were unknown . Recurrence during adjuvant antiestrogen therapy or within the following 12 months or prior endocrine therapy for advanced disease precluded enrollment . One prior chemotherapy regimen for metastatic disease was allowed . The primary end point was time to progression ( TTP ) . Secondary end points included overall objective response rate ( ORR ) , its duration , rate and duration of clinical benefit , time to treatment failure ( TTF ) , overall survival , and tolerability . RESULTS TTP was significantly longer for letrozole than for tamoxifen ( median , 41 v 26 weeks ) . Treatment with letrozole reduced the risk of progression by 30 % ( hazards ratio , 0.70 ; 95 % confidence interval , 0.60 to 0.82 , P = .0001 ) . TTP was significantly longer for letrozole irrespective of dominant site of disease , receptor status , or prior adjuvant antiestrogen therapy . Similarly , TTF was significantly longer for letrozole ( median , 40 v 25 weeks ) . ORR was higher for letrozole ( 30 % v 20 % ; P = .0006 ) , as was the rate of clinical benefit ( 49 % v 38 % ; P = .001 ) . Survival data are currently immature and not reported here . Both treatments were well tolerated . CONCLUSION Letrozole was significantly superior to tamoxifen in TTP , TTF , ORR , and clinical benefit rate . Our results support its use as first-line endocrine therapy in postmenopausal women with advanced breast cancer",
"Purpose To compare the pharmacokinetics of two different dosing methods of fulvestrant ( ' Faslodex ' ) , an estrogen receptor antagonist with no known agonist activity , for the treatment of advanced breast cancer . Methods Postmenopausal women with advanced breast cancer were r and omly assigned to receive a single 5-ml intramuscular injection of 250 mg fulvestrant , or two 2.5-ml intramuscular injections with a total of 250 mg fulvestrant . Blood sample s were taken for pharmacokinetic analysis up to 28 days after injection . Results Plasma concentrations of fulvestrant were measurable up to 28 days after both dosing methods . The concentration-time profiles were relatively shallow , spanning an approximate threefold range from 3 h after dosing to Cmin measured on day 28 . Peak plasma concentrations ( Cmax ) of fulvestrant occurred between 1 and 11 days after dosing , with mean Cmax values of 6.0 and 6.2 ng/ml following one 5-ml injection and two 2.5-ml injections , respectively . The plasma concentration-time profiles were very similar in terms of duration and concentration , and overall exposure to fulvestrant was similar in both dosing groups ( the ratio of the AUC0–28 of the single-injection group to that of the double-injection group was 1.01 ; 95 % confidence interval 0.68–1.51 ) . Conclusion This study found no evidence of any pharmacokinetic difference between one 5-ml injection and two 2.5-ml injections . The two methods can be used interchangeably , depending on which is more convenient in any particular clinical setting",
"Fulvestrant is an estrogen receptor antagonist with no agonist effects . In the second‐line treatment of advanced breast carcinoma , fulvestrant was shown previously to be as effective as the third‐generation aromatase inhibitor , anastrozole , in terms of time to disease progression and objective response rates . The authors reported the overall survival results from these studies",
"PURPOSE To compare the efficacy and tolerability of anastrozole ( Arimidex ; AstraZeneca , Wilmington , DE , and Macclesfield , United Kingdom ) with that of tamoxifen as first-line therapy for advanced breast cancer ( ABC ) in postmenopausal women . PATIENTS AND METHODS This r and omized , double-blind , multicenter study evaluated the efficacy of anastrozole 1 mg once daily relative to tamoxifen 20 mg once daily in patients with tumors that were hormone receptor-positive or of unknown receptor status who were eligible for endocrine therapy . The primary end points were time to progression ( TTP ) , objective response ( OR ) , and tolerability . RESULTS A total of 668 patients ( 340 in the anastrozole arm and 328 in the tamoxifen arm ) were r and omized to treatment and followed-up for a median of 19 months . Median TTP was similar for both treatments ( 8.2 months in patients who received anastrozole and 8.3 months in patients who received tamoxifen ) . The tamoxifen : anastrozole hazards ratio was 0.99 ( lower one-sided 95 % confidence limit , 0.86 ) , demonstrating that anastrozole was at least equivalent to tamoxifen . Anastrozole was also as effective as tamoxifen in terms of OR ( 32.9 % of anastrozole and 32.6 % of tamoxifen patients achieved a complete response [ CR ] or partial response [ PR ] ) . Clinical benefit ( CR + PR + stabilization of > or = 24 weeks ) rates were 56.2 % and 55.5 % for patients receiving anastrozole and tamoxifen , respectively . Both treatments were well tolerated . However , incidences of thromboembolic events and vaginal bleeding were reported in fewer patients treated with anastrozole than with tamoxifen ( 4.8 % v 7.3 % [ thromboembolic events ] and 1.2 % v 2.4 % [ vaginal bleeding ] , respectively ) . CONCLUSION Anastrozole satisfied the predefined criteria for equivalence to tamoxifen . Together with the lower observed incidence of thromboembolic events and vaginal bleeding , these findings indicate that anastrozole should be considered as first-line therapy for postmenopausal women with ABC",
"Summary There is a need for new endocrine agents that lack cross-resistance with currently available treatments to extend the endocrine treatment window and delay the need for cytotoxic chemotherapy . This retrospective analysis evaluated the response of postmenopausal patients with previously untreated metastatic/locally advanced breast cancer to further endocrine treatment following progression on first-line fulvestrant or tamoxifen . Patients received fulvestrant 250 mg ( intramuscular injection every 28 days ) plus matching tamoxifen placebo ( once daily ) , or tamoxifen 20 mg ( orally once daily ) plus matching fulvestrant placebo ( every 28 days ) in a double-blind , r and omized , phase III trial . Treatment continued until disease progression or withdrawal , when further endocrine therapy was initiated ( at the treating physician ’s discretion ) . Information regarding subsequent therapies and responses was obtained by follow-up question naire . Two-hundred- and -forty-five question naires were returned ( from 587 patients ) , 149 of which yielded follow-up data on patients receiving second-line endocrine therapy following fulvestrant ( n=83 ) and tamoxifen ( n=66 ) . Second-line therapy produced objective responses ( OR ) in 6/44 ( 13.6 % ) and clinical benefit ( CB ) in 25/44 ( 56.8 % ) patients who had CB with fulvestrant and produced OR in 5/41 ( 12.2 % ) patients and CB in 27/41 ( 65.8 % ) patients who had CB with first-line tamoxifen . For patients deriving no CB from trial therapy , second-line therapy produced OR in 3/39 ( 7.7 % ) and CB in 15/39 ( 38.5 % ) patients in the fulvestrant group and OR in 4/25 ( 16.0 % ) and CB in 12/25 ( 48.0 % ) patients in the tamoxifen group . Results from this question naire-based study suggest that postmenopausal women with advanced breast cancer who respond to first-line fulvestrant or tamoxifen retain sensitivity to subsequent endocrine therapy",
"PURPOSE To evaluate the efficacy and tolerability of fulvestrant ( Faslodex ; AstraZeneca Pharmaceuticals LP , Wilmington , DE ) , a new estrogen receptor ( ER ) antagonist that downregulates ER and has no agonist effects , versus tamoxifen , an antiestrogen with agonist and antagonist effects , for the treatment of advanced breast cancer in postmenopausal women . PATIENTS AND METHODS In this multicenter , double-blind , r and omized trial , patients with metastatic/locally advanced breast cancer previously untreated for advanced disease were r and omly assigned to receive either fulvestrant ( 250 mg , via intramuscular injection , once monthly ; n = 313 ) or tamoxifen ( 20 mg , orally , once daily ; n = 274 ) . Patients ' tumors were positive for ER ( ER+ ) and /or progesterone receptor ( PgR+ ) , or had an unknown receptor status . RESULTS At a median follow-up of 14.5 months , there was no significant difference between fulvestrant and tamoxifen for the primary end point of time to progression ( TTP ; median TTP , 6.8 months and 8.3 months , respectively ; hazard ratio , 1.18 ; 95 % CI , 0.98 to 1.44 ; P = .088 ) . In a prospect ively planned subset analysis of patients with known ER+ and /or PgR+ tumors ( approximately 78 % ) , median TTP was 8.2 months for fulvestrant and 8.3 months for tamoxifen ( hazard ratio , 1.10 ; 95 % CI , 0.89 to 1.36 ; P = .39 ) . The objective response rate for the overall population was 31.6 % with fulvestrant and 33.9 % with tamoxifen , and 33.2 % and 31.1 % , respectively , in the known hormone receptor-positive subgroup . Both treatments were well tolerated . CONCLUSION In the overall population , between-group differences in efficacy end points favored tamoxifen , and statistical noninferiority of fulvestrant could not be demonstrated . However , in patients with hormone receptor-positive tumors , fulvestrant had similar efficacy to tamoxifen and was well tolerated",
"BACKGROUND Anastrozole is a new oral aromatase inhibitor with highly potent and selective activity for the aromatase enzyme . In a Phase III trial , the efficacy and tolerability of anastrozole , given in doses of 1 and 10 mg orally once daily , and megestrol acetate , given in doses of 40 mg orally 4 times daily , were compared in 386 postmenopausal women with advanced breast carcinoma who progressed after tamoxifen therapy . METHODS The trial was r and omized , double blind for anastrozole , open label for megestrol acetate , parallel group , and multicenter . Patients were r and omly assigned to receive anastrozole , 1 mg ( n = 128 ) ; anastrozole , 10 mg ( n = 130 ) ; or megestrol acetate ( n = 128 ) . The primary efficacy measures were time to progression and tumor response ; secondary measures were time to treatment failure , duration of response , quality of life , and time to death . RESULTS With a median duration of follow-up of 6 months , there was no statistical evidence of a difference between either 1 or 10 mg doses of anastrozole and megestrol acetate for any efficacy endpoint . According to rigid response criteria , 10 % , 6 % , and 6 % of patients in the anastrozole 1 mg , anastrozole 10 mg , and megestrol acetate groups , respectively , had an objective response ( complete response or partial response ) and 27 % , 24 % , and 30 % of patients in the respective groups had stable disease for a duration of 24 weeks or longer . Quality -of-life assessment s revealed that anastrozole in a 1-mg dose was associated with better physical scores and anastrozole in a 10-mg dose with better psychologic scores than megestrol acetate . Both anastrozole and megestrol acetate were generally well tolerated . Among anticipated adverse events , gastrointestinal disturbance was more common among patients in the anastrozole groups , whereas weight gain occurred more frequently among patients in the megestrol acetate groups . Weight increases of 5 % or more and 10 % or more were more common among megestrol acetate-treated patients ; moreover , patients in this group continued to gain weight over time . CONCLUSIONS Anastrozole , given in doses of 1 and 10 mg once daily , represents a well tolerated and effective therapeutic option for the treatment of postmenopausal women with advanced breast carcinoma who progress after tamoxifen treatment",
"PURPOSE This phase III , double-blind , r and omized , multicenter study evaluated the efficacy , pharmacodynamics , and safety of the oral aromatase inactivator exemestane ( EXE ) versus megestrol acetate ( MA ) in postmenopausal women with progressive advanced breast cancer who experienced failure of tamoxifen . PATIENTS AND METHODS A total of 769 patients were r and omized to EXE 25 mg/d ( n = 366 ) or MA ( n = 403 ) 40 mg four times daily . Tumor response , duration of tumor control , tumor-related signs and symptoms ( TRSS ) , quality of life ( QOL ) , survival , and tolerability were evaluated . RESULTS Overall objective response ( OR ) rates were higher in patients treated with EXE than in those treated with MA ( 15.0 % v 12.4 % ) ; a similar trend was noted in patients with visceral metastases ( 13.5 % v 10.5 % ) . Median survival time was significantly longer with EXE ( median not reached ) than with MA ( 123.4 weeks ; P = .039 ) , as were the median duration of overall success ( OR or stable disease > or = 24 weeks ; 60.1 v 49.1 weeks ; P = .025 ) , time to tumor progression ( 20.3 v 16.6 weeks ; P = .037 ) , and time to treatment failure ( 16.3 v 15.7 weeks ; P = .042 ) . Compared with MA , there were similar or greater improvements in pain , TRSS , and QOL with EXE . Both drugs were well tolerated . Grade 3 or 4 weight changes were more common with MA ( 17.1 % v 7.6 % ; P = .001 ) . CONCLUSION EXE prolongs survival time , time to tumor progression , and time to treatment failure compared with MA and offers a well-tolerated treatment option for postmenopausal women with progressive advanced breast cancer who experienced failure of tamoxifen",
"PURPOSE To compare the efficacy and tolerability of anastrozole ( 1 and 10 mg once daily ) , a selective , oral , nonsteroidal aromatase inhibitor , and megestrol acetate ( 40 mg four times daily ) , in postmenopausal women who progressed following tamoxifen treatment . PATIENTS AND METHODS Two r and omized , double-blind for anastrozole , open-label for megestrol acetate , parallel-group , multicenter trials were conducted in 764 patients . Because both trials were identical in design , an analysis of the combined results was performed to strengthen interpretation of results from each trial . RESULTS The median follow-up duration was approximately 6 months . The estimated progression hazards ratios were 0.97 ( 97.5 % confidence interval [ CI ] , 0.75 to 1.24 ) for anastrozole 1 mg versus megestrol acetate and 0.92 ( 97.5 % CI , 0.71 to 1.19 ) for anastrozole 10 mg versus megestrol acetate . The overall median time to progression was approximately 21 weeks . Approximately one third of patients in each group benefited from treatment . Twenty-seven patients ( 10.3 % ) in the anastrozole 1-mg group , 22 ( 8.9 % ) in the anastrozole 10-mg group , and 20 ( 7.9 % ) in the megestrol acetate group had a complete or partial response , and 66 ( 25.1 % ) , 56 ( 22.6 % ) , and 66 ( 26.1 % ) patients , respectively , had stable disease for > or = 24 weeks . For all end points , individual trial results were similar to the results of the combined analysis . Anastrozole and megestrol acetate were well tolerated . Gastrointestinal disturbance was more common among patients in the anastrozole groups than the megestrol acetate group ; the difference between the anastrozole 10 mg and megestrol acetate groups was significant ( P = .005 ) . Significantly fewer patients in the anastrozole 1-mg ( P weight gain than in the megestrol acetate group . More than 30 % of megestrol acetate-treated patients had weight gain > or = 5 % , and 10 % of patients had weight gain > or = 10 % . Patients who received megestrol acetate continued to gain weight over time . CONCLUSION Anastrozole , 1 and 10 mg once daily , is well tolerated and as effective as megestrol acetate in the treatment of postmenopausal women with advanced breast cancer who progressed following tamoxifen treatment . Moreover , anastrozole therapy avoids the weight gain associated with megestrol acetate treatment",
"PURPOSE To compare the efficacy and tolerability of fulvestrant ( formerly ICI 182,780 ) with anastrozole in the treatment of advanced breast cancer in patients whose disease progresses on prior endocrine treatment . PATIENTS AND METHODS In this double-blind , double-dummy , parallel-group study , postmenopausal patients were r and omized to receive either an intramuscular injection of fulvestrant 250 mg once monthly or a daily oral dose of anastrozole 1 mg . The primary end point was time to progression ( TTP ) . Secondary end points included objective response ( OR ) rate , duration of response ( DOR ) , and tolerability . RESULTS Patients ( n = 400 ) were followed for a median period of 16.8 months . Fulvestrant was as effective as anastrozole in terms of TTP ( hazard ratio , 0.92 ; 95.14 % confidence interval [ CI ] , 0.74 to 1.14 ; P = .43 ) ; median TTP was 5.4 months with fulvestrant and 3.4 months with anastrozole . OR rates were 17.5 % with both treatments . Clinical benefit rates ( complete response + partial response + stable disease > or = 24 weeks ) were 42.2 % for fulvestrant and 36.1 % for anastrozole ( 95 % CI , -4.00 % to 16.41 % ; P = .26 ) . In responding patients , median DOR ( from r and omization to progression ) was 19.0 months for fulvestrant and 10.8 months for anastrozole . Using all patients , DOR was significantly greater for fulvestrant compared with anastrozole ; the ratio of average response duration s was 1.35 ( 95 % CI , 1.10 to 1.67 ; P tolerated . CONCLUSION Fulvestrant was at least as effective as anastrozole , with efficacy end points slightly favoring fulvestrant . Fulvestrant represents an additional treatment option for postmenopausal women with advanced breast cancer whose disease progresses on tamoxifen therapy",
"PURPOSE To analyze overall survival ( OS ) and up date efficacy data for letrozole versus tamoxifen as first-line therapy in postmenopausal women with locally advanced or metastatic breast cancer . PATIENTS AND METHODS This multicenter phase III trial r and omly assigned 916 patients with hormone receptor-positive or unknown tumors letrozole 2.5 mg ( n = 458 ) or tamoxifen 20 mg ( n = 458 ) daily until disease progression . Optional cross-over was permitted at the treating physician 's discretion . This report up date s efficacy at a median follow-up of 32 months . RESULTS The superiority of letrozole to tamoxifen was confirmed for time to progression ( median , 9.4 v 6.0 months , respectively ; P time to treatment failure ( median , 9 v 5.7 months , respectively ; P overall objective response rate ( 32 % v 21 % , respectively ; P = .0002 ) , and overall clinical benefit . Median OS was slightly prolonged for the r and omized letrozole arm ( 34 v 30 months , respectively ) . Although this difference in OS is not significant , survival was improved in the r and omized letrozole arm over the first 2 years of the study . Approximately one half of the patients in each arm crossed over . Total duration of endocrine therapy ( \" time to chemotherapy \" ) was significantly longer ( P = .005 ) for patients initially on letrozole ( median , 16 months ) than for patients initially on tamoxifen ( median , 9 months ) . Time to worsening of Karnofsky performance score was significantly delayed with letrozole compared with tamoxifen ( P = .001 ) . CONCLUSION This study documents the superiority of letrozole over tamoxifen in first-line endocrine therapy in postmenopausal women with advanced breast cancer",
"We present an initial survival analysis and an up date of the safety data of the North American and Tamoxifen or Arimidex R and omized Group Efficacy and Tolerability ( TARGET ) double-blind , r and omised , multicentre studies which compared anastrozole with tamoxifen as first-line treatment in postmenopausal patients with oestrogen receptor and /or progesterone receptor-positive ( ER+/PR+ ) or receptor-unknown advanced breast cancer ( ABC ) . At a median follow-up of 43.7 months , 56.0 % of patients in the anastrozole group and 56.1 % of patients in the tamoxifen group had died . The proportion of patients dead at 2 years was 31.1 and 32.0 % in the anastrozole and tamoxifen groups , respectively . In the ER+/PR+ subgroup , 55.1 and 55.9 % of patients had died and median time to deaths ( TTD ) were 40.8 and 41.3 months in the anastrozole and tamoxifen groups , respectively . Both agents remained well tolerated , with fewer reports of vaginal bleeding ( anastrozole versus tamoxifen , 1.0 % versus 2.5 % ) and thromboembolic events ( anastrozole versus tamoxifen , 5.3 % versus 9.0 % ) in the anastrozole group versus the tamoxifen group . Hot flushes and vaginal dryness were reported marginally less in the tamoxifen group compared with the Anastrozole group . Although no improvement in survival was observed , the favourable profile of anastrozole with respect to efficacy ( TTP ) and tolerability [ Cancer 92 ( 2001 ) 2247 ] support the use of anastrozole in advance of tamoxifen as the first-line therapy choice in postmenopausal women with ABC",
"PURPOSE The efficacy and tolerability of anastrozole ( Arimidex ; AstraZeneca , Wilmington , DE , and Macclesfield , United Kingdom ) and tamoxifen were compared as first-line therapy for advanced breast cancer in 353 postmenopausal women . PATIENTS AND METHODS The r and omized , double-blind , multicenter study was design ed to evaluate anastrozole 1 mg once daily relative to tamoxifen 20 mg once daily in patients with hormone receptor-positive tumors or tumors of unknown receptor status who were eligible for endocrine therapy . Primary end points were objective response ( OR ) , defined as complete ( CR ) or partial ( PR ) response , time to progression ( TTP ) , and tolerability . RESULTS Anastrozole was as effective as tamoxifen in terms of OR ( 21 % v 17 % of patients , respectively ) , with clinical benefit ( CR + PR + stabilization > or = 24 weeks ) observed in 59 % of patients on anastrozole and 46 % on tamoxifen ( two-sided P = .0098 , retrospective analysis ) . Anastrozole had a significant advantage over tamoxifen in terms of TTP ( median TTP of 11.1 and 5.6 months for anastrozole and tamoxifen , respectively ; two-sided P = .005 ) . The tamoxifen : anastrozole hazards ratio was 1.44 ( lower one-sided 95 % confidence limit , 1.16 ) . Both treatments were well tolerated . However , thromboembolic events and vaginal bleeding were reported in fewer patients who received anastrozole compared with those who received tamoxifen ( 4.1 % v 8.2 % [ thromboembolic events ] and 1.2 % v 3.8 % [ vaginal bleeding ] , respectively ) . CONCLUSION Anastrozole satisfied the predefined criteria for equivalence to tamoxifen . Furthermore , we observed both a significant increase in TTP and a lower incidence of thromboembolic events and vaginal bleeding with anastrozole . These findings indicate that anastrozole should be considered as first-line therapy for postmenopausal women with advanced breast cancer",
"This report presents the results of a survival up date based on the combined data from two studies that compared the efficacy and tolerability of anastrozole ( 1 or 10 mg once daily ) , a selective , nonsteroidal aromatase inhibitor administered orally , and megestrol acetate ( 40 mg 4 times daily ) in the treatment of postmenopausal women with advanced breast carcinoma whose disease had progressed after treatment with tamoxifen",
"PURPOSE To compare two doses of letrozole and megestrol acetate ( MA ) as second-line therapy in postmenopausal women with advanced breast cancer previously treated with antiestrogens . PATIENTS AND METHODS Five hundred fifty-one patients with locally advanced , locoregionally recurrent or metastatic breast cancer were r and omly assigned to receive letrozole 2.5 mg ( n = 174 ) , letrozole 0.5 mg ( n = 188 ) , or MA 160 mg ( n = 189 ) once daily in a double-blind , multicenter trial . Data were analyzed for tumor response and safety variables up to 33 months of follow-up evaluation and for survival up to 45 months . RESULTS Letrozole 2.5 mg produced a significantly higher overall objective response rate ( 24 % ) compared with MA ( 16 % ; logistic regression , P = .04 ) or letrozole 0.5 mg ( 13 % ; P = .004 ) . Duration of objective response was significantly longer for letrozole 2.5 mg compared with MA ( Cox regression , P = .02 ) . Letrozole 2.5 mg was significantly superior to MA and letrozole 0.5 mg in time to treatment failure ( P = .04 and P = .002 , respectively ) . For time to progression , letrozole 2.5 mg was superior to letrozole 0.5 mg ( P = .02 ) , but not to MA ( P = .07 ) . There was a significant dose effect in overall survival in favor of letrozole 2.5 mg ( P = .03 ) compared with letrozole 0.5 mg . Letrozole was significantly better tolerated than MA with respect to serious adverse experiences , discontinuation due to poor tolerability , cardiovascular side effects , and weight gain . CONCLUSION The data show letrozole 2.5 mg once daily to be more effective and better tolerated than MA in the treatment of postmenopausal women with advanced breast cancer previously treated with antiestrogens",
"The r and omized , double-blind , placebo-controlled trial is the optimum method for clinical evaluation of new treatments , as assessed by clinicians and statisticians . However , if a known st and ard of therapy exists , it may be difficult to prove that a new therapy is superior . Equivalence and noninferiority clinical trial design s are now frequently utilized in clinical medical research . This article review s the statistical differences between superiority , equivalence , and noninferiority design schemes , which pose specific ethical questions and have important implication s for interpretation and clinical application of trial results . A guideline is proposed as a st and ard approach for reporting to facilitate qualitative assessment of the methodology of these trials",
"PURPOSE To compare the efficacy and tolerability of fulvestrant ( formerly ICI 182,780 ) and anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment . PATIENTS AND METHODS Patients ( n = 451 ) with advanced breast cancer were r and omized to receive fulvestrant 250 mg as a once-monthly ( one x 5 mL ) intramuscular injection or an oral dose of anastrozole 1 mg in this open , parallel-group , multicenter trial . The primary end point was time to progression ( TTP ) . Secondary end points included objective response ( OR ) rates , defined as complete response ( CR ) or partial response ( PR ) , duration of response ( DOR ) , and tolerability . RESULTS Patients were followed for a median period of 14.4 months . In terms of TTP , fulvestrant was as effective as anastrozole ( hazard ratio , 0.98 ; confidence interval [ CI ] , 0.80 to 1.21 ; P = .84 ) . Median TTP was 5.5 months for fulvestrant and 5.1 months for anastrozole . OR rates showed a numerical advantage for fulvestrant ( 20.7 % ) over anastrozole ( 15.7 % ) ( odds ratio , 1.38 ; CI , 0.84 to 2.29 ; P = .20 ) . Clinical benefit rates ( CR + PR + stable disease > or = 24 weeks ) were 44.6 % for fulvestrant and 45.0 % for anastrozole . Median DOR was 14.3 months for fulvestrant and 14.0 months for anastrozole . Both treatments were well tolerated , with 3.2 % and 1.3 % of fulvestrant- and anastrozole-treated patients , respectively , withdrawn from treatment because of an adverse event . CONCLUSION Fulvestrant was as effective as anastrozole . These data confirm that fulvestrant is an additional , effective , and well-tolerated treatment for advanced breast cancer in postmenopausal women whose disease progressed on prior endocrine therapy"
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41174a7e-06ff-11f0-808a-c43d1ab1c353
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Objective To evaluate the prevalence and clinical impact of new-onset arrhythmias in patients following transcatheter aortic valve implantation ( TAVI ) . Method We systematic ally identified studies reporting new-onset arrhythmias after TAVI other than atrioventricular conduction disturbances . We summarised monitoring strategies , type and prevalence of arrhythmias and estimated their effect on risk of death or cerebrovascular events by using r and om-effects meta- analysis . The study is registered withInternational prospect i ve register of systematic review s ( PROSPERO ) ( CRD42017058053 ) . Results Sixty-five studies ( 43 506 patients ) reported new-onset arrhythmias following TAVI . The method of arrhythmia detection was specified only in 31 studies ( 48 % ) . New-onset atrial fibrillation ( NOAF ) ( 2641 patients ) , bradyarrhythmias ( 182 patients ) , supraventricular arrhythmias ( 29 patients ) , ventricular arrhythmias ( 28 patients ) and non-specified major arrhythmias ( 855 patients ) were reported . In most studies ( 52 out of 65 ) , new-onset arrhythmia detection was limited to the first month following TAVI . The most frequently documented arrhythmia was NOAF with trend of increasing summary prevalence of 11 % , 14 % , 14 % and 25 % during inhospital , 30-day , 1-year and 2-year follow-ups , respectively ( P for trend=0.011 ) . Summary prevalence estimates of NOAF at 30-day follow-up differ significantly between studies of prospect i ve and retrospective design ( 8 % and 21 % , respectively , P=0.002 ) . New episodes of bradyarrhythmias were documented with a summary crude prevalence of 4 % at 1-year follow-up . NOAF increased the risk of death ( relative risk 1.61 , 95 % CI 1.35 to 1.98 , I2=47 % ) and cerebrovascular events ( 1.79 , 95 % CI 1.24 to 2.64 , I2=0 % ) . No study commented on therapeutic modifications following the detection of new-onset arrhythmias . Conclusions Systematic identification of new-onset arrhythmias following TAVI may have considerable impact on subsequent therapeutic management and long-term prognosis in this patient population
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"BACKGROUND After the approval of transcatheter aortic valve replacement ( TAVR ) for high-risk or inoperable patients with severe aortic stenosis ( AS ) , many low- and moderate-volume TAVR programs were initiated . Contemporary outcomes from these newly initiated centres remain unknown . METHODS In March 2013 , our institution was authorized by the Québec Ministry of Health to perform 30 TAVR procedures . After thorough clinical screening and imaging evaluation , suitable patients underwent transfemoral TAVR with the balloon-exp and able SAPIEN XT ( Edwards Lifesciences , Irvine , CA ) transcatheter heart valve ( THV ) . In-hospital and 30-day outcomes were prospect ively collected and reported according to Valve Academic Research Consortium 2 guidelines . RESULTS From April 2013 to January 2014 , 30 consecutive high-risk ( n = 16 [ 53.3 % ] ) or inoperable ( n = 14 [ 46.7 % ] ) patients ( mean age , 84.6 years ; mean Society of Thoracic Surgery score , 7 ) with symptomatic severe AS underwent transfemoral TAVR . No catastrophic intraprocedural complications such as annulus rupture , valve embolization , aortic dissection , or coronary occlusion occurred , and there were no deaths at 30 days . Disabling stroke occurred in 1 ( 3.3 % ) patient 48 hours after THV implantation . Major vascular complications and major bleeding occurred in 1 ( 3.3 % ) patient . No moderate or severe paravalvular leak was observed . The median length of stay was 2 ( 1 - 3 ) days , with 8 ( 26.7 % ) patients discharged within 24 hours after the procedure . CONCLUSIONS Excellent outcomes can be achieved in newly initiated relatively low-volume centres , which compares favorably to previously published large series . Important considerations include appropriate team training , rigorous patient screening , use of multimodality imaging techniques , a heart team approach , constant integration of lessons learned from larger published experiences , and maintaining a recommended minimum volume of 25 cases per year",
"INTRODUCTION Little is known about the early and late performance of the 31 mm CoreValve Revalving System ( CRS , Medtronic Inc. , Galway , Irel and ) . Our aim was to compare acute and long-term results of the 31 mm CRS with other valve sizes . METHODS Consecutive patients undergoing transcatheter aortic valve implantation ( TAVI ) with CRS in nine Italian centers were prospect ively included and dichotomized according to prosthesis size in two different groups , as follows : 31 mm and other valve sizes ( i.e. , 23 , 26 , and 29 mm combined ) . End points were defined according to Valve Academic Research Consortium definitions . Propensity score matching was performed . RESULTS In total , 2069 patients ( n=169 [ 8 % ] in the 31 mm group and n=1900 [ 92 % ] in the other valve sizes group ) were included . After propensity matching , the implantation of the 31 mm valve was associated with lower rates of procedural- ( 91.3 % vs. 98.1 % , p=0.030 ) and device-success ( 88.5 % vs. 97.1 % , p=0.016 ) , longer procedural time ( 120 [ 80 - 180 ] min . vs. 90 [ 60 - 120 ] min . , p rates of implantation of a second valve ( 10.6 % vs. 2.9 % , respectively , p=0.027 ) . The rates of permanent pacemaker implantation in the 31 mm group were higher but not statistically different from other valve sizes ( 41.7 % vs. 30.9 % , respectively , p=0.149 ) . Significant improvement , without between-group differences , was observed in NYHA functional class . Cardiovascular death was lower in the 31 mm valve group through 2-years ( 3.8 % vs. 13.5 % , respectively , p=0.014 ) . CONCLUSIONS The acute performance of the 31 mm CRS was worse than other valve sizes but no negative impact was observed in long-term outcomes",
"OBJECTIVES This study sought to evaluate the incidence , predictive factors , and prognostic value of new-onset atrial fibrillation ( NOAF ) following transcatheter aortic valve implantation ( TAVI ) . BACKGROUND Very few data exist on the occurrence of NOAF following TAVI . METHODS A total of 138 consecutive patients with no prior history of atrial fibrillation ( AF ) underwent TAVI with a balloon-exp and able valve . Patients were on continuous electrocardiogram monitoring until hospital discharge , and NOAF was defined as any episode of AF lasting > 30 s. All clinical , echocardiographic , procedural , and follow-up data were prospect ively collected . RESULTS NOAF occurred in 44 patients ( 31.9 % ) at a median time of 48 h ( interquartile range : 0 to 72 h ) following TAVI . The predictive factors of NOAF were left atrial ( LA ) size ( odds ratio [ OR ] : 1.21 for each increase in 1 mm/m(2 ) , 95 % confidence interval [ CI ] : 1.09 to 1.34 , p transapical approach ( OR : 4.08 , 95 % CI : 1.35 to 12.31 , p = 0.019 ) . At 30-day follow-up , NOAF was associated with a higher rate of stroke/systemic embolism ( 13.6 % vs. 3.2 % , p = 0.021 , p = 0.047 after adjustment for baseline differences between groups ) , with no differences in mortality rate between groups ( NOAF : 9.1 % , no-NOAF : 6.4 % , p = 0.57 ) . At a median follow-up of 12 months ( interquartile range : 5 to 20 months ) , a total of 27 patients ( 19.6 % ) had died , with no differences between the NOAF ( 15.9 % ) and no-NOAF ( 21.3 % ) groups , p = 0.58 . The cumulative rate of stroke and stroke/systemic embolism at follow-up were 13.6 % and 15.9 % , respectively , in the NOAF group versus 3.2 % in the no-NOAF group ( p = 0.039 , adjusted p = 0.037 for stroke ; p = 0.020 , adjusted p = 0.023 for stroke/systemic embolism ) . CONCLUSIONS NOAF occurred in about one-third of the patients with no prior history of AF undergoing TAVI and its incidence was increased in patients with larger LA size and those undergoing transapical TAVI . NOAF was associated with a higher rate of stroke/systemic embolism , but not a higher mortality , at 30 days and at 1-year follow-up",
"INTRODUCTION Transcatheter aortic valve implantation ( TAVI ) is an effective treatment for high-risk or inoperative patients with severe aortic stenosis . Given the unique characteristics of Asian population s , questions regarding mid-term outcomes in Asians undergoing TAVI have yet to be addressed . We evaluated the two-year clinical outcomes of TAVI in an Asian population using Valve Academic Research Consortium-2 definitions . METHODS This prospect i ve study recruited 59 patients from a major academic medical centre in Singapore . The main outcomes were two-year survival rates , peri-procedural complications , symptom improvement , valvular function and assessment of learning curve . RESULTS Mean age was 76.8 years ( 61.0 % male ) , mean body surface area 1.6 m2 and mean logistic EuroSCORE 18.7 % . Survival was 93.2 % , 86.0 % and 79.1 % at 30 days , one year and two years , respectively . At 30 days post TAVI , the rate of stroke was 1.7 % , life-threatening bleeding 5.1 % , acute kidney injury 25.0 % , major vascular complication 5.1 % , and new permanent pacemaker implantation 6.8 % . 29.3 % of TAVI patients were rehospitalised ( 47.1 % cardiovascular-related ) within one year . These composite outcomes were measured : device success ( 93.2 % ) ; early safety ( 79.7 % ) ; clinical efficacy ( 66.1 % ) ; and time-related valve safety ( 84.7 % ) . Univariate analysis found these predictors of two-year all-cause mortality : logistic EuroSCORE ( hazard ratio [ HR ] 1.07 ; p baseline estimated glomerular filtration rate ( HR 0.97 ; p = 0.048 ) ; and acute kidney injury ( HR 5.33 ; p = 0.022 ) . Multivariate analysis identified non-transfemoral TAVI as a predictor of cardiovascular-related two-year mortality ( HR 14.64 ; p = 0.008 ) . CONCLUSION Despite the unique clinical differences in Asian population s , this registry demonstrated favourable mid-term clinical and safety outcomes in Asians undergoing TAVI",
"BACKGROUND Recent miniaturization of an insertable cardiac monitor ( ICM ) may make it possible to move device insertion from a hospital to office setting . However , the safety of this strategy is unknown . OBJECTIVES The primary objective was to compare the safety of inserting the Reveal LINQ ICM in an office vs a hospital environment . Ancillary objectives included summarizing device- and procedure-related adverse events and responses to a physician question naire . METHODS Five hundred twenty-one patients indicated for an ICM were r and omized ( 1:1 ratio ) to undergo ICM insertion in a hospital or office environment at 26 centers in the United States in the Reveal LINQ In-Office 2 study ( Clinical Trials.gov identifier NCT02395536 ) . Patients were followed for 90 days . RESULTS ICM insertion was successful in all 482 attempted patients ( office : 251 ; hospital : 231 ) . The untoward event rate ( composite of unsuccessful insertion and ICM- or insertion-related complications ) was 0.8 % ( 2 of 244 ) in the office and 0.9 % ( 2 of 227 ) in the hospital ( 95 % confidence interval , -3.0 % to 2.9 % ; 5 % noninferiority : P adverse events occurred during 2.5 % ( 6 of 244 ) of office and 4.4 % ( 10 of 227 ) of hospital insertions ( 95 % confidence interval [ office minus inhospital rates ] , -5.8 % to 1.9 % ; 5 % noninferiority : P fewer delays > 15 minutes ( 16 % vs 35 % ; P response was more often \" very positive . \" Physicians considered the office location \" very convenient \" more frequently than the hospital location ( 85 % vs 27 % ; P safety profile for the insertion of the Reveal LINQ ICM is excellent irrespective of insertion environment . These results may exp and site of service options for LINQ insertion",
"OBJECTIVES The study sought to examine the safety and performance of transcatheter aortic valve replacement ( TAVR ) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR . BACKGROUND Although women comprise 50 % of patients with symptomatic severe aortic stenosis undergoing TAVR , the optimal treatment strategy remains undetermined . METHODS The WIN-TAVI ( Women 's INternational Transcatheter Aortic Valve Implantation ) registry is a multinational , prospect i ve , observational registry of women undergoing TAVR for aortic stenosis , conducted without any external funding . The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days ( composite of mortality , stroke , major vascular complication , life-threatening bleeding , stage 2 or 3 acute kidney injury , coronary artery obstruction , or repeat procedure for valve-related dysfunction ) . RESULTS Between January 2013 and December 2015 , 1,019 women were enrolled across 19 European and North American centers . The mean patient age was 82.5 ± 6.3 years , mean EuroSCORE I was 17.8 ± 11.7 % and mean Society of Thoracic Surgeons score was 8.3 ± 7.4 % . TAVR was performed via transfemoral access in 90.6 % and new-generation devices were used in 42.1 % . In more than two-thirds of cases , an Edwards SAPIEN 23 mm ( Edwards Lifesciences , Irvine , California ) or Medtronic CoreValve ≤26 mm ( Medtronic Inc. , Minneapolis , Minnesota ) device was implanted . The 30-day VARC-2 composite endpoint occurred in 14.0 % with 3.4 % all-cause mortality , 1.3 % stroke , 7.7 % major vascular complications , and 4.4 % VARC life-threatening bleeding . The independent predictors of the primary endpoint were age ( odds ratio [ OR ] : 1.04 ; 95 % confidence interval [ CI ] : 1.00 to 1.08 ) , prior stroke ( OR : 2.02 ; 95 % CI : 1.07 to 3.80 ) , left ventricular ejection fraction Women enrolled in this first ever all-female TAVR registry with collection of female sex-specific baseline parameters , were at intermediate-high risk and experienced a 30-day VARC-2 composite safety endpoint of 14.0 % with a low incidence of early mortality and stroke . R and omized assessment of TAVR versus surgical aortic valve replacement in intermediate risk women is warranted to determine the optimal strategy",
"Background —Atrial fibrillation ( AF ) is an important risk factor for stroke and is common among elderly patients undergoing transcatheter aortic valve implantation . The aim of this study was to assess the impact of AF on clinical outcomes among patients undergoing transcatheter aortic valve implantation . Methods and Results —Between August 2007 and October 2011 , a total of 389 high-risk patients undergoing transcatheter aortic valve implantation were included into a prospect i ve registry . AF was recorded in 131 patients ( 33.7 % ) with a mean CHA2DS2–VASC score of 4.5±1.2 and was paroxysmal in 26 ( 25.0 % ) , persistent in 8 ( 7.7 % ) , and permanent in 70 patients ( 67.3 % ) . Patients with and without AF had similar baseline characteristics except for fewer revascularization procedures ( coronary artery bypass grafting : 12 % versus 22 % ; P=0.03 ) among AF patients . At 1 year , all-cause mortality was higher among patients with AF ( 30.9 % ) compared with those without AF ( 13.9 % ; hazard ratio [ HR ] , 2.36 ; 95 % confidence interval [ CI ] , 1.43–3.90 ; P=0.0008 ) . This was observed irrespective of the type of AF ( permanent , HR , 2.47 ; 95 % CI , 1.40–4.38 ; persistent , HR , 3.60 ; 95 % CI , 1.10–11.78 ; paroxysmal , HR , 2.88 ; 95 % CI , 1.37–6.05 ) . Mortality gradually increased with higher CHA2DS2–VASC scores ( score 1–3 : HR , 2.20 ; 95 % CI , 0.92–5.27 ; score 6–8 : HR , 4.12 ; 95 % CI , 2.07–8.20 ) . The risks of stroke ( 3.9 % versus 5.1 % ; HR , 0.76 ; 95 % CI , 0.23–1.96 ; P=0.47 ) and life-threatening bleeding ( 19.8 % versus 14.7 % ; HR , 1.37 ; 95 % CI , 0.86–2.19 ; P=0.19 ) were similar among patients with and without AF . Conclusions —AF is common among high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation and is associated with a > 2-fold increased risk of all-cause and cardiovascular mortality , irrespective of the type of AF . The gradient of risk directly correlates with the CHA2DS2–VASC score",
"OBJECTIVES This analysis presents the first report of 1-year outcomes of the 120 patients enrolled in the REPRISE II ( Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance ) study . BACKGROUND The fully repositionable and retrievable Lotus Valve ( Boston Scientific , Marlborough , Massachusetts ) was design ed to facilitate accurate positioning , early valve function , and hemodynamic stability during deployment and to minimize paravalvular regurgitation in patients undergoing transcatheter aortic valve replacement . METHODS The study enrolled 120 symptomatic patients 70 years of age or older at 14 centers in Australia and Europe . Patients had severe calcific aortic stenosis and were deemed to be at high or extreme risk of surgery based on assessment by the heart team . RESULTS The mean age was 84.4 ± 5.3 years , 57 % ( 68 of 120 ) of patients were women , and the mean Society of Thoracic Surgeons score was 7.1 ± 4.6 . The mean baseline aortic valve area was 0.7 ± 0.2 cm(2 ) , and the mean transvalvular pressure gradient was 46.4 ± 15.0 mm Hg . All patients were successfully implanted with a Lotus Valve , and 1-year clinical follow-up was available for 99.2 % ( 119 of 120 of patients ) . The mean 1-year transvalvular aortic pressure gradient was 12.6 ± 5.7 mm Hg , and the mean valve area was 1.7 ± 0.5 cm(2 ) . A total of 88.6 % patients had no or trivial paravalvular aortic regurgitation at 1 year by independent core lab adjudication , and 97.1 % of patients were New York Heart Association functional class I or II . At 1 year , the all-cause mortality rate was 10.9 % ( 13 of 119 patients ) , disabling stroke rate was 3.4 % ( 4 of 119 patients ) , disabling bleeding rate was 5.9 % ( 7 of 119 patients ) , with no repeat procedures for valve-related dysfunction . A total of 31.9 % ( 38 of 119 patients ) underwent new permanent pacemaker implantation at 1 year . CONCLUSIONS At 1 year of follow-up , the Lotus Valve demonstrated excellent valve hemodynamics , no moderate or severe paravalvular regurgitation , and significant and sustained improvement in New York Heart Association functional class status , with good clinical outcomes . ( Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance [ REPRISE II ] ; NCT01627691 )",
"BACKGROUND There is limited data from Australia and New Zeal and comparing transcatheter aortic valve implantation ( TAVI ) with conventional surgical aortic valve replacement ( sAVR ) . METHODS Between 2009 and 2015 , 64 patients underwent TAVI and 669 underwent sAVR at a single centre . Patients ' peri-operative details were analysed and compared between groups . Propensity-score matching was performed for risk adjustment . RESULTS Patients receiving TAVI were older ( mean age in years TAVI : 83.9±4.6 vs. sAVR : 71±9.9 , P female ( TAVI : 67 % , 43/64 , vs. sAVR : 32 % , 217/669 , P 0.001 ) . Unadjusted 30-day mortality was comparable between groups ( 2/64 , 3 % vs. 22/669 , 3 % , P > 0.99 ) . The matched analysis revealed comparable 30-day mortality ( TAVI : 2/44 , 5 % vs. sAVR : 2/44 , 5 % , P > 0.99 ) . New atrial arrhythmia occurred more frequently within the sAVR cohort ( TAVI : 1/44 , 2 % vs. sAVR 18/44 , 41 % , P was more frequent amongst the TAVI cohort ( TAVI : 10/44 , 23 % vs. sAVR 2/44 , 5 % , P=0.039 ) . At two years , survival was comparable between groups ( TAVI : 74±1.7 vs. sAVR : 80±0.1 % , P=0.65 ) . CONCLUSION This single centre experience suggests that TAVI is a valuable treatment option for high-risk surgical patients with comparable survival",
"Mortality after transcatheter aortic valve implantation ( TAVI ) has been reported to range up to 3 years . However , long-term mortality remains underexplored . The aims of this study were to determine long-term mortality in patients who undergo TAVI and to identify correlates of long-term death . From a single institution 's prospect ively collected TAVI data base , all patients who underwent TAVI with a maximum follow-up duration of 5 years were analyzed . The population was analyzed on the basis of access route ( transapical TAVI or transfemoral TAVI ) . Cox regression and Kaplan-Meier survival analysis were conducted . A total of 511 patients who underwent TAVI were included in the analysis ( transapical TAVI n = 115 , transfemoral TAVI n = 396 ) . The mean Society of Thoracic Surgeons score was 9.6 ± 4 . Mortality at 30 days ( 18 % vs 6 % , p . Long-term survival probability was 0.33 ) . Vascular complications ( hazard ratio [ HR ] 2.14 , 95 % confidence interval [ CI ] 1.38 to 3.33 , p = 0.001 ) , more than mild aortic insufficiency ( HR 1.81 , 95 % CI 1.15 to 2.83 , p = 0.01 ) , atrial fibrillation ( HR 1.87 , 95 % CI 1.36 to 2.57 , p ) , and in-hospital stroke ( HR 2.35 , 95 % CI 1.39 to 4.00 , p = 0.002 ) were independently associated with long-term death . The survival probability of patients at high surgical risk versus those who were inoperable was similar in the long term ( log-rank p = 0.53 ) . In conclusion , the overall long-term survival of patients with aortic stenosis who were approved to undergo TAVI was reducing in-hospital stroke , vascular complications , and aortic regurgitation are still needed , as these variables are correlates of long-term mortality",
"INTRODUCTION AND OBJECTIVES Transcatheter aortic valve implantation is used as an alternative to surgical valve replacement in patients with severe aortic stenosis who are considered high-surgical-risk or inoperable . Two of the main areas of uncertainty in this field are valve durability and long-term survival . METHODS This prospect i ve single-center registry study from a tertiary hospital included all consecutive patients who underwent percutaneous aortic valve implantation between 2008 and 2012 . Clinical follow-up lasted a minimum of 2.5 years and a maximum of 6.5 years . Valve Academic Research Consortium-2 definitions were used . RESULTS Seventy-nine patients were included , with an immediate success rate of 94.9 % . The median survival was 47.6 months ( 95 % confidence intervals , 37.4 - 57.9 months ) , ie , 4 years . One quarter of deaths occurred in the first month , and most were of cardiovascular cause . After the first month , most deaths were due to noncardiovascular causes . The mean values of valve gradients did not increase during follow-up . The cumulative rate of prosthetic valve dysfunction was 15.3 % , with no cases of repeat valve replacement . CONCLUSIONS Half of the patients with aortic stenosis who underwent transcatheter aortic valve implantation were alive 4 years after the procedure . There was a 15.3 % prosthetic valve dysfunction rate in cumulative follow-up , with no cases of repeat valve replacement",
"BACKGROUND We compared transcatheter aortic-valve replacement ( TAVR ) , using a self-exp and ing transcatheter aortic-valve bioprosthesis , with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery . METHODS We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center . Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors . Eligible patients were r and omly assigned in a 1:1 ratio to TAVR with the self-exp and ing transcatheter valve ( TAVR group ) or to surgical aortic-valve replacement ( surgical group ) . The primary end point was the rate of death from any cause at 1 year , evaluated with the use of both noninferiority and superiority testing . RESULTS A total of 795 patients underwent r and omization at 45 centers in the United States . In the as-treated analysis , the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group ( 14.2 % vs. 19.1 % ) , with an absolute reduction in risk of 4.9 percentage points ( upper boundary of the 95 % confidence interval , -0.4 ; P TAVR was noninferior with respect to echocardiographic indexes of valve stenosis , functional status , and quality of life . Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke . CONCLUSIONS In patients with severe aortic stenosis who are at increased surgical risk , TAVR with a self-exp and ing transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement . ( Funded by Medtronic ; U.S. CoreValve High Risk Study Clinical Trials.gov number , NCT01240902 . )",
"Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies",
"Introduction The impact of coronary artery disease ( CAD ) on outcomes after transcatheter aortic valve implantation ( TAVI ) has not been clarified . Furthermore , less is known about the indication and strategy of revascularization in these high risk patients . Aims This study sought to determine the prevalence and prognostic impact of CAD in patients undergoing TAVI , and to assess the safety and feasibility of percutaneous coronary intervention ( PCI ) before TAVI . Methods Patients with severe aortic stenosis ( AS ) undergoing TAVI were included into a prospect i ve single center registry from 2007 to 2012 . Clinical outcomes were compared between patients with and without CAD . In some patients with CAD , it was decided to perform elective PCI before TAVI after decision by the Heart team . The primary endpoints were 30-day and 2-year all-cause mortality . Results A total of 91 consecutive patients with mean age of 79 ± 9 years ( 52 % men ) underwent TAVI with a median follow-up duration of 16 months ( interquartile range of 27.6 months ) . CAD was present on 46 patients ( 51 % ) . At 30-day , the incidences of death were similar between CAD and non-CAD patients ( 9 and 5 % , p = 0.44 ) , but at 2 years were 50 % in CAD patients and 24 % in non-CAD patients [ crude hazard ratio with CAD , 2.2 ; 95 % confidence interval ( CI ) , 1.1–4.6 ; p = 0.04 ] . Adjusting for age , gender , left ventricular ejection fraction , and glomerular filtration rate , the hazard of death was 2.6-fold higher in patients with CAD ( 95 % CI , 1.1–6.0 ; p = 0.03 ) . Elective PCI before TAVI was performed in 13 patients ( 28 % of CAD patients ) . There were no more adverse events in patients who underwent TAVI + PCI when compared with those who underwent isolated TAVI . Conclusion In severe symptomatic AS who underwent TAVI , CAD is frequent and adversely impacts long-term outcomes , but not procedure outcomes . In selected patients , PCI before TAVI appears to be feasible and safe ",
"OBJECTIVES This study sought to determine whether outcomes for transfemoral ( TF ) transcatheter aortic valve replacement ( TAVR ) differ between the r and omized controlled trial ( RCT ) and the subsequent NRCA ( Nonr and omized Continued Access ) registry of the PARTNER ( Placement of AoRTic TraNscathetER Valves ) trial . BACKGROUND The PARTNER RCT demonstrated that TAVR with the Edwards Sapien valve ( Edwards Lifesciences , Irvine , California ) is noninferior to surgery in high-risk patients and superior to st and ard therapy for inoperable patients . METHODS The inclusion and exclusion criteria , data collection , monitoring , and core laboratories were the same for the RCT and NRCA registry . Baseline characteristics , procedural results , and 1-year outcomes were compared between patients undergoing TF-TAVR as part of the RCT and as part of the NRCA registry . RESULTS In the RCT , 415 patients underwent TF-TAVR , whereas in the NRCA , 1,023 patients did . At 30 days , death , cardiac death , stroke , and transient ischemic attacks were not different in the NRCA registry than in the RCT . Major vascular complications ( 8.0 % vs. 15.7 % , p major bleeding ( 6.8 % vs. 15.3 % , p death rates were significantly lower in the NRCA cohort ( 19.0 % vs. 25.3 % , p = 0.009 ) and cardiac death tended to be lower ( 8.4 % vs. 11.1 % , p = 0.12 ) . Stroke or transient ischemic attack ( 6.2 % vs. 8.7 % , p = 0.10 ) and stroke alone ( 5.0 % vs. 7.1 % , p = 0.13 ) also tended to be lower . CONCLUSIONS The large NRCA registry demonstrates further improvement in procedural and longer-term outcomes after TF-TAVR when compared with the favorable results from the PARTNER RCT . ( THE PARTNER TRIAL : Placement of AoRTic TraNscathetER Valve Trial ; NCT00530894 )",
"AIMS This study sought to investigate outcomes of transcatheter aortic valve implantation ( TAVI ) with the SAPIEN 3 transcatheter heart valve ( THV ) in patients at intermediate risk for surgery . The 30-day results of the transfemoral cohort are reported . METHODS AND RESULTS The SAPIEN 3 European approval trial intermediate-risk cohort included a total of 101 patients with severe , symptomatic aortic stenosis , at intermediate risk for surgery suitable for TAVI via the transfemoral route ( TF ) . Outcomes were adjudicated by a clinical events committee . Echocardiography , computed tomography and electrocardiography exams were analysed in core laboratories . The mean STS-PROM score and logistic EuroSCORE of the study population were 5.2±1.7 and 13.2±3.8 , respectively . A completely percutaneous procedure was performed in 90.1 % of patients and conscious sedation and /or local anaesthesia was utilised in 54.5 % . Technical success was achieved in 98.0 % of patients . At 30 days , mortality was 1.0 % , with stroke in 3.0 % and a new permanent pacemaker in 4.0 % ( 4.3 % of patients without pre-procedural permanent pacemaker ) . No patients had severe aortic regurgitation after the procedure , only one patient had moderate aortic regurgitation , and 70.8 % of patients had no or trace aortic regurgitation . CONCLUSIONS TF-TAVI using the SAPIEN 3 THV in patients at intermediate risk for surgery is associated with a very low risk of death and complications , including new pacemakers and paravalvular leaks . Although compelling , these initial results are being confirmed in larger global studies before exp and ing the indications for TAVI in severe aortic stenosis",
"Background —The Nordic Aortic Valve Intervention ( NOTION ) trial was the first to r and omize all-comers with severe native aortic valve stenosis to either transcatheter aortic valve replacement ( TAVR ) with the CoreValve self-exp and ing bioprosthesis or surgical aortic valve replacement ( SAVR ) , including a lower-risk patient population than previous trials . This article reports 2-year clinical and echocardiographic outcomes from the NOTION trial . Methods and Results —Two-hundred eighty patients from 3 centers in Denmark and Sweden were r and omized to either TAVR ( n=145 ) or SAVR ( n=135 ) with follow-up planned for 5 years . There was no difference in all-cause mortality at 2 years between TAVR and SAVR ( 8.0 % versus 9.8 % , respectively ; P=0.54 ) or cardiovascular mortality ( 6.5 % versus 9.1 % ; P=0.40 ) . The composite outcome of all-cause mortality , stroke , or myocardial infa rct ion was also similar ( 15.8 % versus 18.8 % , P=0.43 ) . Forward-flow hemodynamics were improved following both procedures , with effective orifice area significantly more improved after TAVR than SAVR ( effective orifice area , 1.7 versus 1.4 cm2 at 3 months ) . Mean valve gradients were similar after TAVR and SAVR . When patients were categorized according to Society of Thoracic Surgeons Predicted Risk of Mortality ( STS-PROM ) ( lower-risk patients . Longer-term data are needed to verify the durability of this procedure in this patient population . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT01057173",
"OBJECTIVES The aim of this study was to determine the impact of pre-existing right bundle branch block ( RBBB ) on clinical outcomes after transcatheter aortic valve replacement ( TAVR ) . BACKGROUND The impact of pre-existing RBBB on clinical outcomes after TAVR is unknown . METHODS Between October 2013 and August 2015 , 749 patients undergoing TAVR using the Edwards SAPIEN XT prosthesis were prospect ively enrolled in the OCEAN-TAVI ( Optimized Transcatheter Valvular Intervention ) registry from 8 Japanese centers . Electrocardiograms were obtained at baseline . After the procedure , follow-up outpatient visits or telephone interviews were conducted at 30 days , 6 months , and yearly . RESULTS A total of 102 patients ( 13.6 % ) had pre-existing RBBB . The incidence of new pacemaker implantation was significantly higher in the RBBB group ( 17.6 % vs. 2.9 % ; p cardiovascular survival probability was significantly lower in the RBBB group than the no-RBBB group ( log-rank p risk for cardiovascular mortality in the early phase after discharge , and patients with RBBB and pacemakers had higher cardiovascular mortality at mid-term follow-up ( log-rank p = 0.01 ) . A multivariate Cox regression model indicated that pre-existing RBBB ( hazard ratio : 2.59 ; 95 % confidence interval : 1.15 to 5.85 ; p of cardiovascular mortality . CONCLUSIONS Patients with RBBB demonstrated an increased risk for cardiovascular mortality after TAVR , and patients with RBBB and without pacemakers were at higher risk for cardiac death early after discharge . Patients with prior RBBB should be carefully monitored after undergoing TAVR",
"BACKGROUND Acute kidney injury ( AKI ) after transcatheter aortic valve implantation ( TAVI ) is frequent and is associated with adverse outcomes . Past studies have attributed AKI to impaired kidney function at baseline , amount of contrast medium used , major bleeding , and hemodynamic instability during the procedure . Because major bleeding might play a role in the development of AKI , we analyzed the relationship between periprocedural bleeding and the development of AKI and assessed the impact of these 2 important procedure-related complications on outcome . METHODS Consecutive patients undergoing transfemoral TAVI for severe aortic stenosis were prospect ively recruited . AKI and bleeding events during hospitalization were recorded , defined , and classified according to the Valve Academic Research Consortium 2 definitions . Logistic and Cox regression was used for predictor and survival analyses . RESULTS We recruited 422 consecutive patients who underwent TAVI ; the mean follow-up duration was 576 ± 400 days . AKI occurred in 66 ( 15.6 % ) patients . No patient required dialysis . Fifty patients ( 12 % ) had major or life-threatening bleeding . Periprocedural major or life-threatening bleeding was a strong predictor of the development of AKI ( odds ratio , 3.19 ; 95 % confidence interval [ CI ] , 1.38 - 7.1 ; P = 0.006 ) . Major bleeding was a strong independent predictor for both 30-day and long-term mortality ( hazard ratio [ HR ] , 6.67 ; 95 % CI , 2.2 - 19.8 ; P = 0.001 and HR , 3.3 , 95 % CI , 1.2 - 9.0 ; P = 0.02 , respectively ) , whereas AKI was not independently associated with increased mortality after TAVI . CONCLUSIONS In patients undergoing transfemoral TAVI , periprocedural bleeding is a strong risk factor for the development of AKI and a major determinant of short- and long-term mortality ",
"BACKGROUND Temporal development of new-onset atrial fibrillation ( NOAF ) after aortic valve replacement is unclear , and opportunistic screening has limited diagnostic accuracy . This is the first study to investigate the incidence and temporal development of NOAF detected by implantable loop recorder ( ILR ) in patients with aortic stenosis , r and omized to surgical aortic valve replacement ( SAVR ) or transcatheter aortic valve replacement ( TAVR ) . METHOD An ILR was implanted in a subgroup of patients without pre-procedural atrial fibrillation ( AF ) , r and omized to SAVR or TAVR in the NOTION trial . Data from the ILR were transmitted in intervals of 2weeks for 12weeks post-procedurally and analyzed . RESULTS The study included 25 and 27 patients who underwent SAVR and TAVR , respectively . The cumulative rate of NOAF was 100 % and 81.5 % for patients undergoing SAVR and TAVR , respectively ( P=0.06 ) . TAVR patients without NOAF 6weeks post-procedurally remained free from NOAF . The prevalence of AF after SAVR decreased significantly after 8weeks when compared with the first 2weeks ( 50.0 % vs. 84.0 % , respectively ; P prevalence of AF after TAVR did not change significantly during follow-up . The median AF burden ( percentage of time with AF ) was 2.8 % and 0.04 % during the first 2weeks after SAVR and TAVR , respectively ( P=0.01 ) and it decreased significantly over time after SAVR but not after TAVR . CONCLUSION NOAF subsided 6weeks after TAVR . AF prevalence and burden decreased significantly over time after SAVR , but remained stable after TAVR . These findings may be considered for post-procedural anti-coagulation strategy",
"AIMS Transcatheter aortic valve implantation ( TAVI ) is a therapeutic treatment for patients with severe aortic stenosis ( AS ) at high surgical risk . Although the procedure is associated with a reduction in total mortality , there are no data regarding changing in the incidence of premature ventricular contractions ( PVCs ) and ventricular arrhythmias ( VAs ) after TAVI . The aim of this study was to assess the incidence of VAs before and after TAVI . METHODS AND RESULTS We enrolled 237 patients who underwent TAVI at our centre . Ninety-one patients were excluded for the following reasons : presence of prior permanent pacemaker ( PPM ) ( n = 20 ) , new PPM implant after TAVI ( n = 48 ) , death during the follow-up period ( n = 16 ) , and lost at follow-up ( n = 7 ) . Finally , 146 patients were included in our analysis . The presence of VAs was evaluated in all patients recording a 24 h Holter monitoring before the procedure and after 1 and 12 months . Ventricular arrhythmias were classified according to a modified Lown grading system . Before the procedure , isolates PVCs ( grade 1 - 2 of Lown grading system ) were present in 34.9 % of patients ( n = 51 ) . Complex PVCs ( grade 3 - 4a-4b of Lown grading system ) were present in 48.6 % of the population ( multifocal PVCs in 32 patients , 21.9 % ; pairs in 25 patients , 17.1 % ; ventricular tachycardia in 14 patients , 9.6 % ) . One month after the procedure , we observed statistically significant incidence decrease of arrhythmias of grade 3 ( from 21.9 to 17.1 % ) and grade 4 ( pairs from 17.1 to 12.3 % ; ventricular tachycardia from 9.6 to 4.8 % ) . After 12 months , there was a further significant reduction in the frequency and severity of PVCs . In particular , 45.8 % of patients had isolates PVCs ( frequency of complex arrhythmias was reduced to 16.4 % ( multifocal PVCs in 13 patients , 9 % ; couplets 8 patients , 5.5 % and ventricular tachycardia in 3 patients , 2.0 % ) . The difference was statistically significant ( P VAs are common in patients with AS . We observed a significant decrease in the incidence and severity of PVCs since the first month after TAVI . Furthermore , after 1 year follow-up there was a further and significant reduction in the frequency of complex PVCs . This may be related to the benefits determined by valve replacement on left ventricular function",
"BACKGROUND Previous trials have shown that among high-risk patients with aortic stenosis , survival rates are similar with transcatheter aortic-valve replacement ( TAVR ) and surgical aortic-valve replacement . We evaluated the two procedures in a r and omized trial involving intermediate-risk patients . METHODS We r and omly assigned 2032 intermediate-risk patients with severe aortic stenosis , at 57 centers , to undergo either TAVR or surgical replacement . The primary end point was death from any cause or disabling stroke at 2 years . The primary hypothesis was that TAVR would not be inferior to surgical replacement . Before r and omization , patients were entered into one of two cohorts on the basis of clinical and imaging findings ; 76.3 % of the patients were included in the transfemoral-access cohort and 23.7 % in the transthoracic-access cohort . RESULTS The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group ( P=0.001 for noninferiority ) . At 2 years , the Kaplan-Meier event rates were 19.3 % in the TAVR group and 21.1 % in the surgery group ( hazard ratio in the TAVR group , 0.89 ; 95 % confidence interval [ CI ] , 0.73 to 1.09 ; P=0.25 ) . In the transfemoral-access cohort , TAVR result ed in a lower rate of death or disabling stroke than surgery ( hazard ratio , 0.79 ; 95 % CI , 0.62 to 1.00 ; P=0.05 ) , whereas in the transthoracic-access cohort , outcomes were similar in the two groups . TAVR result ed in larger aortic-valve areas than did surgery and also result ed in lower rates of acute kidney injury , severe bleeding , and new-onset atrial fibrillation ; surgery result ed in fewer major vascular complications and less paravalvular aortic regurgitation . CONCLUSIONS In intermediate-risk patients , TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke . ( Funded by Edwards Lifesciences ; PARTNER 2 Clinical Trials.gov number , NCT01314313 . )",
"BACKGROUND / OBJECTIVES To determine pacemaker ( PM ) dependency at follow-up visit in patients who underwent new permanent pacemaker implantation ( PPI ) following transcatheter aortic valve implantation ( TAVI ) . METHODS Single center prospect i ve observational study including 167 patients without previous PM implantation who underwent TAVI with the self-exp and ing Medtronic CoreValve System ( MCS ) between November 2005 and February 2011 . PM dependency was defined by the presence of a high degree atrioventricular block ( HDAVB ; second [ AV2 ] and third degree [ AV3B ] ) , or a slow ( ventricular escape rhythm during follow-up PM interrogation . RESULTS A total of 36 patients ( 21.6 % ) received a new PM following TAVI . The indication for PM was AV2B ( n=2 , 5.6 % ) , AV3B ( n=28 , 77.8 % ) , postoperative symptomatic bradycardia ( n=3 , 8.3 % ) , brady-tachy syndrome ( n=1 , 2.8 % ) , atrial fibrilation with slow response ( n=1 , 2.8 % ) and left bundle branch block ( n=1 , 2.8 % ) . Long term follow-up was complete for all patients and ranged from 1 to 40 months ( median ( IQR ) : 11.5 ( 5.0 - 18.0 months ) . Of those patients with a HDAVB , 16 out of the 30 patients ( 53.3 % ) were PM independent at follow-up visit ( complete or partial resolution of the AV conduction abnormality ) . Overall , 20 out of the 36 patients ( 55.6 % ) who received a new PM following TAVI were PM independent at follow-up . CONCLUSION Partial and even complete resolution of peri-operative AV conduction abnormalities after MCS valve implantation occurred in more than half of the patients",
"OBJECTIVES This study sought to determine the incidence of new-onset atrial fibrillation ( AF ) associated with different methods of isolated aortic valve replacement (AVR)-transfemoral ( TF ) , transapical ( TA ) , and transaortic ( TAo ) catheter-based valve replacement and conventional surgical approaches . BACKGROUND The relative incidences of AF associated with the various access routes for AVR have not been well characterized . METHODS In this single-center , retrospective cohort study , we evaluated a total of 231 consecutive patients who underwent AVR for degenerative aortic stenosis ( AS ) between March 2010 and September 2012 . Patients with a history of paroxysmal , persistent , or chronic AF , with bicuspid aortic valves , and patients who died within 48 h after AVR were excluded . A total of 123 patients ( 53 % of total group ) qualified for inclusion . Data on documented episodes of new-onset AF , along with all clinical , echocardiographic , procedural , and 30-day follow-up data , were collated . RESULTS AF occurred in 52 patients ( 42.3 % ) . AF incidence varied according to the procedural method . AF occurred in 60 % of patients who underwent surgical AVR ( SAVR ) , in 53 % after TA-TAVR , in 33 % after TAo-TAVR cases , and 14 % after TF-TAVR . The episodes occurred at a median time interval of 53 ( 25th to 75th percentile , 41 to 87 ) h after completion of the procedure . Procedures without pericardiotomy had an 82 % risk reduction of AF compared with those with pericardiotomy ( adjusted odds ratio : 0.18 ; 95 % confidence interval : 0.05 to 0.59 ) . CONCLUSIONS AF was a common complication of AVR with a cumulative incidence of > 40 % in elderly patients with degenerative AS who underwent either SAVR or TAVR . AF was most common with SAVR and least common with TF-TAVR . Procedures without pericardiotomy were associated with a lower incidence of AF",
"BACKGROUND The use of a balloon-exp and able transcatheter heart valve previously result ed in a greater rate of device success compared with a self-exp and able transcatheter heart valve . OBJECTIVES The aim of this study was to evaluate clinical and echocardiographic outcome data at longer term follow-up . METHODS The investigator-initiated trial r and omized 241 high-risk patients with symptomatic severe aortic stenosis and anatomy suitable for treatment with both balloon- and self-exp and able transcatheter heart valves to transfemoral transcatheter aortic valve replacement with either device . Patients were followed-up for 1 year , with assessment of clinical outcomes and echocardiographic evaluation of valve function . RESULTS At 1 year , the rates of death of any cause ( 17.4 % vs. 12.8 % ; relative risk [ RR ] : 1.35 ; 95 % confidence interval [ CI ] : 0.73 to 2.50 ; p = 0.37 ) and of cardiovascular causes ( 12.4 % vs. 9.4 % ; RR : 1.32 ; 95 % CI : 0.63 to 2.75 ; p = 0.54 ) were not statistically significantly different in the balloon- and self-exp and able groups , respectively . The frequencies of all strokes ( 9.1 % vs. 3.4 % ; RR : 2.66 ; 95 % CI : 0.87 to 8.12 ; p = 0.11 ) and repeat hospitalization for heart failure ( 7.4 % vs. 12.8 % ; RR : 0.58 ; 95 % CI : 0.26 to 1.27 ; p = 0.19 ) did not statistically significantly differ between the 2 groups . Elevated transvalvular gradients during follow-up were observed in 4 patients in the balloon-exp and able group ( 3.4 % vs. 0 % ; p = 0.12 ) ; all were resolved with anticoagulant therapy , suggesting a thrombotic etiology . More than mild paravalvular regurgitation was more frequent in the self-exp and able group ( 1.1 % vs. 12.1 % ; p = 0.005 ) . CONCLUSIONS Despite the higher device success rate with the balloon-exp and able valve , 1-year follow-up of patients in CHOICE ( R and omized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis : Medtronic CoreValve Versus Edwards SAPIEN XT Trial ) , with limited statistical power , revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with both balloon- and self-exp and able prostheses that were not statistically significantly different . ( A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis : The CHOICE Trial ; NCT01645202 )"
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The suitable duration of antibiotic use following appendectomy for advanced appendicitis in children is still debated . A systematic review was performed , including published experimental and observational data of antibiotic use in children who had undergone appendectomy for advanced appendicitis . Data were extracted and analyzed according to predefined criteria . Twenty-eight studies were selected that included 2,284 patients . There was no consistency among the protocol s regarding length of antibiotic use , discharge criteria , or use of home antibiotics following discharge . Limiting duration of antibiotic use to3 days did not appear to be associated with higher rates of intraabdominal abscess or wound infection . In the absence of higher-level evidence , shortening of antibiotic regimens following surgery for pediatric complicated appendicitis appears to be safe
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"BACKGROUND Intraperitoneal culturing during appendectomy is a routine procedure . Significant decrease in the mortality and dramatic improvement in the morbidity were achieved by using antibiotics perioperatively . The value of intraoperative abdominal cavity culture was assessed in our study . METHODS A total of 499 patients formed two groups , those with acute nonperforated appendicitis ( group A ) and those with perforated appendicitis ( group B ) . Intraoperative abdominal cavity culture were taken r and omly in both groups . The perioperative morbidity , the validity , and the impact of positive culture on the antibiotic treatment were examined in both groups . RESULTS Clinical diagnosed perforation was confirmed histologically in 176 patients ( 98.3 % accuracy ) . Intraperitoneal cultures were obtained in 30.1 % of the patients in group A and in 67.1 % of group B. The majority of the patients in group A were treated preoperatively and postoperatively by a single antibiotic agent whereas 58.0 % of the patients in group B were started on triple-agent antibiotics for significantly longer periods ( 22.4 + /- 9.4 versus 5.7 + /- 7.4 doses , respectively ; P postoperative complication rate ( wound infection , intra-abdominal abscess and small bowel obstruction ) whether intra-abdominal culture was obtained or not ( 5.9 % versus 4.7 % in group A and 21.2 % versus 21.9 % in group B ; P > 0.05 ) . CONCLUSION Traditional intraoperative abdominal cavity culture can be ab and oned . In perforated appendicitis , colonic flora can be predicted , and antibiotic therapy should begun without any abdominal cavity culture results . This practical approach will save money and reduce laboratory work without affecting the patient 's morbidity",
"Sulbactam is a beta-lactamase inhibitor , which when administered with ampicillin , increases the latter agents antibacterial activity against beta-lactamase producing organisms . One hundred children between the ages of 5 and 14 undergoing emergency appendectomy were entered into a prospect i ve r and omized trial comparing sulbactam and ampicillin ( SA ) with metronidazole and cefotaxime ( MC ) as prophylaxis against postoperative wound infection . Patients in whom the appendix was perforated or gangrenous received a 72-hour course of antibiotics , others received a single dose only . The overall wound infection rate was 8 % ( 14 % in patients with perforation or gangrene and 4 % in those without ) . There was no difference in infection rate between the two antibiotic groups ; there were three wound infections and one subphrenic abscess in patients receiving SA and four wound infections in patients receiving MC . SA , therefore , appears to be a suitable antibiotic combination for use as prophylaxis in appendicitis in children",
"A prospect i ve r and omised study ( I ) was carried out on 130 children undergoing laparotomy for perforated appendicitis . The present study evaluates the therapeutic effectiveness of different antibiotic regimens in modifying the rate of post-operative complications ( intraabdominal abscess , ileus , wound infiltration or abscess ) . During the first year of this study two treatment groups were used . Group A consisted of 29 children treated with Sulfometrol/Trimethoprim ; the rate of postoperative complications was 44.8 % . Group B consisted of 36 children treated with mezlocillin , the rate of complications being 13.8 % . However , the same treatment with mezlocillin during the second year of the prospect i ve study showed an increase of this rte to 39 % ( 28 children -- group C ) . The final group of 37 children was treated during the second year with mezlocillin and metronidazole ( group D ) . The postoperative rate of complications was 10.8 % . A retrospective analysis of further 80 children ( study II ) with perforated appendicitis treated with mezlocillin and metronidazole showed a consistent low rate of postoperative complications at 10.2 % . In 6.8 % of children studied , an operative intervention was necessary ( four cases of ileus , four wound abscesses ) . The mean postoperative hospitalisation period decreased from 22.7 days in group A to 15.2 days in group D and finally to 14 days in study II . The present study shows that an effective and persistent attenuation of the rate of postoperative complications after perforated appendicitis in children depends on an early onset of therapy and on the appropriate choice of antibiotic drugs that are effective against aerobic and anaerobic microorganisms",
"A prospect i ve , r and omized , double-blind clinical trial was undertaken comparing gentamicin , ampicillin , and clindamycin ( GAC ) to gentamicin , ampicillin , and placebo ( GAP ) in children with complicated appendicitis . Of the 64 patients enrolled in this study , 33 were assigned to the GAC group and 31 received GAP . A single GAC patient ( 3 % ) was considered a therapeutic failure in comparison to seven children ( 23 % ) in the GAP group ( P less than 0.05 ) . Duration of fever was significantly prolonged in the GAP patients ( 4.7 + /- .8 days versus 2.9 + /- .5 days ) when compared to the clindamycin treated children ( P less than 0.05 ) . Duration of leukocytosis was 3.2 + /- .4 days for GAC patients and 4.9 + /- .9 days for those on the GAP protocol ( P = 0.08 ) . On the basis of this experience the routine use of gentamicin , ampicillin , and clindamycin is recommended for all children with complicated appendicitis",
"A prospect i ve study was conducted on 344 children aged from 3 months to 16 years with acute appendicitis . Most children presented with typical features of acute appendicitis ( 70 % ) or peritonitis ( 28 % ) . Atypical presentation was uncommon and occurred only in seven young children , masquerading as intestinal obstruction , gastroenteritis or urinary tract infection . Prolonged delay in surgery was associated with a rise in incidence of late appendicitis ( gangrenous and perforated appendicitis ) . This rise was especially marked 37 h after onset of symptoms . The main causes of delay were inability of the parents and primary care medical practitioners to recognize the disease early . Surgeons contributed very little to the delay . High risk factors for postappendectomy sepsis were young children under 6 years old , late appendicitis , obese patients , inferior systemic antibiotic regimes and inexperienced surgeons . Young children had high postoperative sepsis mainly because of the high incidence of late appendicitis due to their inability to express their symptoms properly . They were not especially prone to postappendectomy sepsis ; they had the same degree of appendicitis compared with older children . Measures to decrease the postappendectomy morbidity are suggested",
" 60 consecutive children operated for perforated appendicitis were treated r and omly with either penicillin and streptomycin or with clindamycin and gentamycin . Suppurative complications occurred somewhat more often and were definitely more severe in the former group . The number of hospital days spent in the treatment of these complications were three times as great in the former than in the latter group . Bacteroides fragilis could be isolated in most of the severe infections treated without clindamycin . Two out of 28 patients treated with clindamycin presented with severe diarrhoea",
"BACKGROUND / PURPOSE Controversy persists in the management of perforated appendicitis with regard to antibiotic choice and duration , operative timing , drain utilization , and wound closure . For 2 decades at the authors ' institution , patients were treated with ampicillin , gentamicin , and clindamycin for 10 inpatient days , with drains in the abdomen , result ing in lower complication rates than most other published series . Managed care pressures have led to less aggressive medical management regimens with length of stay and financial factors viewed as principal outcome measures with little emphasis on clinical outcomes . In addition , there are little prospect i ve data on clinical outcomes . The authors sought to determine whether our previously documented excellent quality outcomes could be maintained when modifications aim ed at decreasing cost and length of stay in our protocol were instituted . METHODS The authors monitored prospect ively clinical outcomes in patients with perforated appendicitis treated according to their clinical practice guidelines over a 43-month period . Patients received a single antibiotic , piperacillin-tazobactam , intravenously for 10 days . They were permitted to go home with a percutaneous intravenous catheter for the final 5 days if medical and social criteria were met . Other practice s from our earlier protocol were continued , including immediate operation , placement of Penrose drains , and primary wound closure . RESULTS Of 150 patients treated on our protocol , major complications included intraabdominal abscess in 5 ( 3.3 % ) , cecal fistula in 2 ( 1.3 % ) , phlegmon in 3 ( 2.0 % ) , wound infection in 4 ( 2.7 % ) , and no small bowel obstructions requiring operation . None of these complications , nor their aggregate , were significantly more common than those reported in 373 patients treated over 11 years on the authors ' prior protocol ( chi2 , P > .05 ) . CONCLUSIONS Prospect i ve outcome analysis of our protocol shows that a single broad-spectrum antibiotic ( allowing portions of therapy to be delivered less expensively on an outpatient basis ) effectively can treat postoperative appendicitis with very few infectious complications . These outcome data provide baseline against which future protocol s can be compared . All treatment modifications aim ed at decreasing costs must be analyzed to ensure quality of care is not unduly compromised",
"In a multicentre trial we compared the clinical efficacy of amoxicillin/clavulanate used as a single-agent therapy with that of the three-agent combination usually prescribed in the post-operative period for appendicular peritonitis in children . Only bacteriologically documented peritoneal infections were included . Sixty-four patients were r and omly distributed between two groups : Group A ( 29 cases ) treated with amoxicillin/clavulanate , first administered iv ( 100 mg/kg/d ) , followed by conversion to the oral route ( 50 mg/kg/d ) once the patient had been afebrile for 48 hours ; Group B ( 35 cases ) first treated by the iv route with benzylpenicillin ( 100,000 IU/kg/d ) plus netilmicin ( 5 mg/kg/d ) plus metronidazole ( 30 mg/kg/d ) , followed by conversion to the oral route for metronidazole ( 30 mg/kg/d ) . In both groups , the total duration of parenteral and oral treatment was not less than 5 days . One hundred and seventy nine bacterial strains were recovered from peritoneal fluid sample s obtained during surgery ; 86 % of these were sensitive to amoxicillin/clavulanate . Clinical efficacy , assessed on the basis of time until return to normal temperature and gut transit and duration of hospitalization , was identical in both groups , with follow-up monitoring on day 30 showing recovery in all cases . Cure was obtained without any problems of infection in 25/29 patients in group A and in 34/35 patients in group B ( non significant difference ) . Tolerance was excellent and identical in the two groups with the exception of three cases of thrombophlebitis which occurred in group B. The results of this study suggest that amoxicillin/clavulanate may be useful as single-agent therapy as a first-line curative treatment for appendicular peritonitis in children",
"Optimal management of children with perforated appendicitis remains a controversial clinical problem . Until very recently , the criteria for hospital discharge on our surgical service included the absence of fever and leukocytosis for a period of 48 hours following completion of antimicrobial therapy , uncomplicated wound healing , a normal rectal examination , and unimpaired gastrointestinal function . With the introduction of cost-containment programs , the necessity for the period of inpatient observation following cessation of antibiotics was question ed . The records of 87 consecutive children with perforated appendicitis were analyzed prospect ively in order to determine if our discharge policies were medically sound and cost-effective . Seventy-five patients ( 86 % ) recovered uneventfully while 12 children required prolonged hospitalization for management of various postoperative complications . The 12 patients who developed complications were all identifiable early in the postoperative period because of persistent fever , leukocytosis , and elevated b and counts . Of the 75 children who recovered uneventfully , all met st and ard discharge criteria on the final day of antibiotic therapy with the exception of completing the m and atory 48-hour period of inpatient observation . These children were maintained in the hospital a total of 142 additional days following discontinuation of antibiotics . The average cost per patient day for children with perforated appendicitis during the study period was $ 506.32 , which represented unnecessary hospital charges of $ 71,897.44 . It was concluded that inpatient observation following cessation of antibiotic therapy in children who experience an uneventful recovery from perforated appendicitis is neither necessary nor cost-effective . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Although single antimicrobials with broad-spectrum aerobic and anaerobic coverage are effective in patients with appendicitis , many general surgeons continue to use multiple agents . A prospect i ve , doubleblind , r and omized trial was design ed to detect any clinical correlate of in vitro susceptibility advantage of multiple antimicrobials as adjunctive therapy for 114 patients undergoing operation for complicated appendicitis . There was clinical resolution of intraabdominal infections with no occurrence of postoperative infectious complications in 90 % ( 36 of 40 ) of the cefotetan group and 86 % ( 31 of 36 ) of the clindamycin/amikacin group ( p=0.11 ) . The number of patients who had changes in antibiotic therapy due to postoperative complications was higher in the clindamycin/amikacin group : five ( 12.5 % ) , compared to one ( 2.8 % ) in the cefotetan group ( p=0.07 ) . Although Bacteroides fragilis group organisms resistant to cefotetan were identified , none was responsible for the postoperative infections . Adverse drug events in 28 % of the cefotetan group and 26 % of the clindamycin/amikacin group consisted primarily of transient elevations of liver function tests . Monotherapy with a second-generation , broad-spectrum cephalosporin , such as cefotetan , given twice a day is an economical and effective adjunctive regimen in patients with complicated appendicitis for which operation is the definitive treatment . Aminoglycosides and other , more potent antimicrobials should be reserved for resistant organisms or nosocomial infections . RésuméBien qu'un seul antibiotique avec un large spectre couvrant les germes aérobies et anaérobies soit reconnu comme efficace dans l'appendicite , beaucoup de chirurgiens continuent d'utiliser une polyantibiothérapie . Dans un essai contrôlé en double aveugle , nous avons testé la corrélation clinique avec la sensibilité in vitro d'une association de plusieurs antibiotiques comme traitement complémentaire chez 114 patients ayant eu une appendicite compliquée . Quatre-vingt pour-cent ( 36/40 ) des patients ayant eu du céfotétan et 86 % ( 31/36 ) des patients ayant eu l'association clindamycine/amikacíne n'ont pas eu de complications infectieuses postopératoires ( p=0.11 ) . II a été nécessaire de changer les antibiotiques en raison d'une complication postopératoire plus souvent chez les patients ayant eu l'association clindamycine/amikacine , 5 ( 12 % ) comparé à 1 ( 2 % ) dans le groupe céfotétan ( p=0.07 ) . On a identifié des organismes Bacteroides fragilis résistants au céfotétane mais aucun n'était responsable d'infection postopératoire . II y a eu des effets secondaires non désirables , essentiellement une perturbation des tests de la fonction hépatique , chez 28 % et chez 26 % des patients ayant pris respectivement du céfotétane et l'assocíation clindamycine/amikacine , respectivement . Une monothérapie avec une céphalosporine de deuxième génération du type céfotétan , donnée deux fois par jour , est ffficace et économique dans le traitement de l'appendicite compliquée mais opéréc . Les aminosides et les autres antibiotiques plus puissants doivent être réservés pour les germes résistants ou les infections nosocomiales . ResumenAunque los antibióticos únicos de amplio espectro de cobertura aeróbica y anaeróbica son eficaces en la apendicitis , muchos cirujanos continúan utiliz and o agentes múltiples . Se diseñó un ensayo clínico prospect ivo , doble ciego y aleatorizado con el fin de correlacionar la susceptibilidad in vitro de agentes antimicrobianos múltiples como terapia adyuvante en el manejo de 114 pacientes sometidos a operación por apendicitis complicada . 90 % ( 36/40 ) de los pacientes en el Grupo de cefotetan y 86 % ( 31/36 ) en el Grupo que recibió clindamicina/amikacina tuvieron resolución clínica de sus infecciones intraabdominales sin recurrencia de complicaciones sépticas postoperatorias ( P=0.11 ) . El número de pacientes que tuvieron cambio en la terapia antibiótica por complicaciones postoperatorias fue más alto en el Grupo clindamicina/amikacina , 5 ( 12 % ) comparados con 1 ( 2 % ) en el Grupo cefotetan ( P=0.07 ) . Aunque se identifícaron microorganismos del Grupo de los Bacteroides fragilis resistentes a cefotetan , ninguno fue responsable de infecciones postoperatorias . Se presentaron reacciones farmacológicas adversas en 28 % del Grupo cefotetan y en 26 % del Grupo clindamicina/amikacina , las cuales consistieron primordialmente en elevaciones pasajeras de los valores de las pruebas de función hepática . La monoterapia con una cefalosporina de amplio espectro de segunda generación , tal como el cefotetan , administrado en dos dosis diarias constituye un régimen económico y eficaz en la apendicitis complicada en la cual la cirugía representa el tratamiento definitivo . Los aminoglucósidos y otros agentes antimicrobianos más potentes deben ser reservados para el tratamiento de infecciones nosocomiales por microorganismos resistentes",
"A prospect i ve r and omized study was undertaken to compare the use of the combination of gentamicin and clindamycin with single agent , cefoxitin , in the treatment of perforated appendicitis in the pediatric patient . In a 3-year period from 1986 to 1989 , 56 patients with perforated appendicitis were r and omized . Twenty-nine patients received cefoxitin , and 27 patients received gentamicin and clindamycin . Antibiotics were started before operation and continued for a minimum of 6 days after operation . Skin and subcutaneous tissues were left open at surgery and closed secondarily after day 3 , if they appeared to be clean . Wounds were considered infected if they developed increased purulence with positive wound cultures . Age range was similar in both groups , with a mean of 9 years ( range , 1 to 17 years ) ; 28 were boys and 28 were girls . No changes in antibiotics were required for reasons of susceptibility . No adverse drug reactions occurred in either group . The most common organisms were Escherichia coli in 35 cases ( 62 % ) and Bacteroides species in 26 cases ( 46 % ) . No difference was noted in infection complications in the two groups nor in length of hospital stay . Therefore , no difference is evident in the use of cefoxitin versus gentamicin and clindamycin in the treatment of perforated appendicitis in terms of disease or drug-related complications",
"Abstract . We evaluated the morbidity associated with primary closure by interrupted subcuticular absorbable sutures following emergency appendectomy . In a prospect i ve clinical trial over a 12-month period , 216 children who underwent emergency appendectomy had skin closure using subcuticular interrupted absorbable polyglactin 4 - 0 sutures . Preoperative prophylactic antibiotics consisting of metronidazole alone or in combination with gentamicin were used in patients with suspected phlegmonous appendicitis ; a combination of metronidazole , gentamicin , and ampicillin was used when perforation of the appendix was suspected . Postoperatively , in patients with phlegmonous appendicitis metronidazole was given for 24 hours , whereas in those with peritonitis the triple antibiotics were continued for 7 to 10 days . All patients were assessed for complications result ing from the technique of wound closure . No intraabdominal abscesses or serious complications were recorded . The overall incidence of wound infection was 1.8 % . Among children with a perforated appendix the rate of superficial wound infection was 5.7 % . There was no difference in the rate of wound infection between patients who received metronidazole alone or metronidazole plus gentamicin preoperatively . All the patients and their families were satisfied with the cosmetic results and with the fact that removal of skin sutures was unnecessary . We conclude that the use of prophylactic antibiotics permits st and ard skin closure by interrupted absorbable subcuticular suture",
"BACKGROUND Children with a perforated or gangrenous appendix become clinical ly stable after medical and /or surgical therapy but often remain in the hospital solely to complete parenteral antibiotic therapy . This prospect i ve study investigates the outcomes when children who meet specified criteria are discharged to complete parenteral antibiotic therapy at home . METHODS Children age 1 to 17 years with appendicitis complicated by generalized peritonitis or intraabdominal abscess were eligible to participate . Subjects whose fever was decreasing , who were able to tolerate oral liquids and for whom further parenteral antibiotic therapy was deemed necessary were discharged from the hospital to receive outpatient parenteral antiinfective therapy ( OPAT ) with meropenem . Therapy was administered by a family member and supervised by home care nurses . Study personnel visited the home daily to collect data on adverse events , compliance and re source utilization . Pa tients served as their own controls in models of reduced hospitalization and net cost savings . RESULTS Discharged on average on the fourth postoperative day , 87 children received 4.5 + /- 2.1 days of OPAT . Six ( 7 % ) children were subsequently readmitted for complications including bowel obstruction ( 4 children ) , intraabdominal abscess ( 1 child ) and pleural effusion ( 1 child ) . Another child developed a viral syndrome during OPAT . All other patients recovered uneventfully . Six ( 7 % ) children discontinued meropenem prematurely because of rash ( 4 patients ) or diarrhea ( 2 patients ) . According to models in which each day of OPAT replaced a day of inpatient care , discharge to OPAT reduced hospitalization by 42 + /- 15 % and saved a median of $ 2908 ( 10th to 90th percentile range , $ 1,077 to $ 4,707 ) per patient . CONCLUSION Convalescent phase OPAT is a cost-effective alternative to continued hospitalization for children with complicated appendicitis who are clinical ly stable yet require further parenteral antibiotic therapy",
"Sulbactam is a beta-lactamase inhibitor that , when combined with ampicillin , gives the latter antibiotic a broad spectrum of activity , making it suitable for use as a prophylactic agent in acute appendicitis . In a single-blind , r and omized trial , the efficacy of sulbactam plus ampicillin was compared with that of metronidazole plus cefotaxime . Thirty-five children undergoing appendectomy received intravenous sulbactam and ampicillin , while 38 children received metronidazole and cefotaxime . Single doses were given unless the appendix was considered gangrenous or perforated , in which case the drugs were administered for 72 hr . There were three wound infections in the group given sulbactam and ampicillin and five in the group given metronidazole and cefotaxime . The combination of sulbactam and ampicillin was well tolerated and appeared to be at least as effective as that of metronidazole and cefotaxime in the prevention of sepsis following appendectomy",
"The efficacy of imipenem-cilastatin was compared with that of tobramycin and metronidazole for the treatment of appendicitis-associated abdominal infections in children in an open , r and omized trial . Two hundred eighteen patients between 2.5 and 16.8 years of age hospitalized for appendectomy because of suspected acute appendicitis were allocated to 5 treatment groups . The appendix was perforated in 54 ( 33.8 % ) of the 160 cases with appendicitis . All patients responded favorably to treatment . Infection in the wound coccurred in 15 of 125 ( 12.0 % ) of those without preoperative",
"A prospect i ve study on the management of severe acute appendicitis with gangrene and perforation was carried out using protocol s that included schematized treatment . The schemes emphasized adequate preoperative treatment , meticulous operative technique of peritoneal toileting , generous use of appropriate antibiotics in combinations , and early grade d patient 's ambulation in the postoperative period . The average hospital stay was seven days , wound infection was of mild degree and less than 1 % , and there was a low morbidity . Follow-up has shown no serious complications",
"Appendectomy for the diagnosis of appendicitis was prospect ively performed upon 133 children from 1 July 1982 to 30 June 1985 with no mortality . The pathologic diagnosis revealed 11 normal appendices ( 8.3 per cent ) , 54 instances of acute appendicitis ( 40.6 per cent ) , 16 instances of gangrenous appendicitis ( 12.0 per cent ) and 52 instances of perforated appendicitis ( 39.1 per cent ) . There were no complications in those patients with normal appendices , acute appendicitis and gangrenous appendicitis and the mean length of hospitalization for these groups was 3.27 , 3.37 and 4.75 days , respectively . The mean length of hospitalization for patients with perforated appendicitis was significantly longer , 9.45 days ( p less than 0.05 ) . Thirteen complications developed in 11 patients with perforated appendicitis . Eight patients required a reoperation ( a major morbidity rate of 15.4 per cent ) . There was only one readmission which occurred three and one-half weeks after discharge for intestinal obstruction . Early appendectomy in children with a presumed diagnosis of either acute or perforated appendicitis result ed in low morbidity rates and is more cost effective than nonoperative management proposed by others due to shorter hospitalization and no planned readmission",
"HYPOTHESIS For children with perforated appendicitis , the use of a prolonged course of intravenous ( i.v . ) antibiotics is equivalent to a short course of i.v . antibiotics followed by sequential conversion to oral ( PO ) antibiotics . DESIGN Prospect i ve , r and omized , clinical trial . SETTING Multicenter study in tertiary children 's hospitals . PATIENTS Children ( aged 5 - 18 years ) with perforated appendicitis found at laparotomy . INTERVENTION Children were r and omized after appendectomy either to a 10-day course of a combination of i.v . ampicillin , gentamicin sulfate , and clindamycin ( n = 10 ) ; or to a short course of a combination of i.v . ampicillin , gentamicin , and clindamycin , followed by conversion to a combination of p.o . amoxicillin and clavulanate potassium plus metronidazole ( n = 16 ) . MAIN OUTCOME MEASURES The primary outcome measure was clinical success , which was rated as complete , partial , or failure . Secondary outcome measures included return of oral intake , duration of fever , return of normal white blood cell count , and patient charges . Treatment equivalence was determined using confidence interval analysis . RESULTS We found treatment equivalence between the i.v . and i.v./p.o . groups , with 6 ( 60 % ) complete and 4 ( 40 % ) partial successes for the 10 patients in the i.v . group and 15 ( 94 % ) complete and 1 ( 6 % ) partial successes for the 16 patients in the i.v./p.o . group ( P return of oral intake , duration of fever , or return of normal white blood cell count between the groups . Conversion to oral therapy results in savings of approximately $ 1500 per case . CONCLUSION There is treatment equivalence between prolonged i.v . therapy and i.v . therapy followed by conversion to oral antibiotic therapy in children with perforated appendicitis",
"OBJECTIVE To compare the therapeutic efficacy of four antibiotic regimens : penicillin , tobramycin , and clindamycin ; penicillin , tobramycin , and ornidazole ; piperacillin alone ; and ceftriaxone and ornidazole in the treatment of children operated on for perforated appendicitis . DESIGN Prospect i ve r and omised study . SETTING Teaching hospital , Turkey . SUBJECTS 200 patients aged between 1 and 16 years treated from December 1991 to December 1995 who were r and omly assigned to one of four groups each consisting of 50 patients . INTERVENTIONS Preoperative antibiotics given intravenously , peritoneal drainage by Penrose drains without irrigation , appendicectomy with the inversion of the stump by a purse string , taking peritoneal swabs , and primary skin closure . MAIN OUTCOME MEASURES Comparability of the groups , duration of fever , leucocytosis , antibiotic treatment , stay in hospital , nasogastric intubation , and drainage , as well as results of cultures and complications . RESULTS There were no significant differences between the groups for any variable studied . The predominant bacterial species were Escherichia coli , Klebsiella spp , Pseudomonas spp , Fusobacteria , and Peptostreptococci which were appropriately covered by all the antibiotic regimens . Fourteen patients had complications including wound infections ( n = 10 ) , prolonged ileus ( n = 2 ) and intra-abdominal abscess ( n = 2 ) all of which were treated conservatively . There was no mortality and no major complications . All regimens had the same clinical and bacteriological efficacy . CONCLUSION There is no gold st and ard for antimicrobial chemotherapy in perforated appendicitis . Different antibiotic combinations or a single broad spectrum antibiotic , which include both aerobic and anaerobic coverage , can safely be used in children with perforated appendicitis",
"St and ard therapy for childhood ruptured appendicitis includes combination antibiotic therapy with ampicillin , gentamicin and clindamycin . Complicated dosing schedules and the possibility of aminoglycoside toxicity make alternatives desirable . One such alternative is Timentin ( a combination agent of ticarcillin disodium and clavulanate potassium ) . This agent has a more convenient dose schedule than st and ard therapy and eliminates the possibility of aminoglycoside ototoxicity and nephrotoxicity . It is active in vitro against most pathogens associated with ruptured appendicitis in children . The preliminary results of an ongoing prospect i ve , open label , r and omized trial comparing ticarcillin and clavulanate with ampicillin , gentamicin and clindamycin in childhood ruptured appendicitis are reported herein . While further evaluation is necessary , we have found single agent therapy with ticarcillin and clavulanate to be equivalent in safety and efficacy to st and ard combination therapy . Also discussed are the relative merits of immediate versus delayed primary closure of the abdominal wound after appendectomy",
"One hundred children with peritonitis result ing from a perforated appendix were treated with ceftazidime or netilmicin . Metronidazole was added to both groups to treat the anaerobic organisms commonly associated with the infecting aerobic organisms in peritonitis . Escherichia coli was the most common aerobe found in peritoneal pus . Wound infection occurred in nine patients of the netilmicin group and in none treated with ceftazidime ( P less than 0.01 ) . No bacterial resistance was evident in the ceftazidime group , but gram-positive streptococci found in eight patients were resistant to netilmicin . Thus it is recommended that an antibiotic of the penicillin group be added if netilmicin is used to treat peritonitis . The results indicate that ceftazidime was more effective than netilmicin in the treatment of children with peritonitis result ing from a perforated appendix"
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41174af6-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Allergies and food reactions in infants and children are common and may be associated with a variety of foods including adapted cow 's milk formula . Soy based formulas have been used to treat infants with allergy or food intolerance . However , it is unclear whether they can help prevent allergy and food intolerance in infants without clinical evidence of allergy or food intolerance . OBJECTIVES To determine the effect of feeding adapted soy formula compared to human milk , cow 's milk formula or a hydrolysed protein formula on preventing allergy or food intolerance in infants without clinical evidence of allergy or food intolerance . SEARCH STRATEGY The st and ard search strategy of the Cochrane Neonatal Review Group was used . Up date d search es were performed of the Cochrane Central Register of Controlled Trials ( CENTRAL , The Cochrane Library , Issue 1 , 2006 ) , MEDLINE ( 1966-March 2006 ) , EMBASE ( 1980-March 2006 ) , CINAHL ( 1982-March 2006 ) and previous review s including cross references . SELECTION CRITERIA R and omised and quasi-r and omised trials that compare the use of an adapted soy formula to human milk , an adapted cow 's milk or a hydrolysed protein formula for feeding infants without clinical allergy or food intolerance in the first six months of life . Only trials with > 80 % follow up of participants and reported in group of assignment were eligible for inclusion . DATA COLLECTION AND ANALYSIS Eligibility of studies for inclusion , method ological quality and data extraction were assessed independently by each review author . Primary outcomes included clinical allergy , specific allergies and food intolerance . Where no heterogeneity of treatment effect was found , the fixed effect model was used for meta- analysis . Where significant or apparent heterogeneity was found , results were reported using the r and om effects model and potential causes of the heterogeneity were sought . MAIN RESULTS Three eligible studies enrolling high risk infants with a history of allergy in a first degree relative were included . No eligible study enrolled infants fed human milk . No study examined the effect of early , short term soy formula feeding . All compared prolonged soy formula to cow 's milk formula feeding . One study was of adequate methodology and without unbalanced allergy preventing co- interventions in treatment groups . One study with unclear allocation concealment and 19.5 % losses reported a significant reduction in infant allergy , asthma and allergic rhinitis . However , no other study reported any significant benefits from the use of a soy formula . Meta- analysis found no significant difference in childhood allergy incidence ( 2 studies ; typical RR 0.73 , 95 % CI 0.37 , 1.44 ) . No significant difference was reported in one study in infant asthma ( RR 1.10 , 95 % CI 0.86 , 1.40 ) , infant eczema ( RR 1.20 , 95 % CI 0.95 , 1.52 ) , childhood eczema prevalence ( RR 1.10 , 95 % CI 0.73 , 1.68 ) , infant rhinitis ( RR 0.94 , 95 % CI 0.76 , 1.16 ) or childhood rhinitis prevalence ( RR 1.20 , 95 % CI 0.73 , 2.00 ) . Meta- analysis found no significant difference in childhood asthma incidence ( 3 studies , 728 infants ; typical RR 0.71 , 95 % CI 0.26 , 1.92 ) , childhood eczema incidence ( 2 studies , 283 infants ; typical RR 1.57 , 95 % CI 0.90 , 2.75 ) or childhood rhinitis incidence ( 2 studies , 283 infants ; typical RR 0.69 , 95 % CI 0.06 , 8.00 ) . One study reported no significant difference in infant CMPI ( RR 1.09 , 95 % CI 0.45 , 2.62 ) , infant CMA ( RR 1.09 , 95 % CI 0.24 , 4.86 ) , childhood soy protein allergy incidence ( RR 3.26 , 95 % CI 0.36 , 29.17 ) and urticaria . No study compared soy formula to hydrolysed protein formula . AUTHORS ' CONCLUSIONS Feeding with a soy formula can not be recommended for prevention of allergy or food intolerance in infants at high risk of allergy or food intolerance . Further research may be warranted to determine the role of soy formulas for prevention of allergy or food intolerance in infants unable to be breast fed with a strong family history of allergy or cow 's milk protein intolerance
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"AIMS Different protein sources could determine differences in the maturation of the exocrine pancreas in humans during the first months after birth ; however , no studies have been carried out in man to evaluate the effect of a hydrolyzed protein diet on exopancreatic function . Our aim was therefore to determine the effect of two different milk formulas on pancreatic secretion in patients with cow 's milk protein allergy ( CMPA ) . METHODS We selected 12 infants ( median age , 3.0 months ) , fed for 6 weeks with a hydrolyzed casein-based formula , and 14 infants ( median age , 3.0 months ) who received a soy-protein based formula over the same period . As controls , two groups of age-matched infants with no gastrointestinal disease and receiving a free diet were studied . In the patients with CMPA a secretin-cerulein test was performed at the commencement of the diet and after 6 weeks ; in the controls the same test was performed only once . Enzyme concentrations and outputs of trypsin , chymotrypsin , lipase , and phospholipase were assayed . RESULTS No significant difference was observed between the two groups of patients with CMPA for any of the enzymes studied , either at base line or after 6 weeks of diet . No difference was recorded between CMPA patients and age-matched controls on a free diet either . In both CMPA groups there was a significant increase over basal values in trypsin , chymotrypsin , and lipase concentrations after 6 weeks . Furthermore , there was a significant positive correlation between the age of the patients and enzyme concentrations . Mean daily weight gain was 27.4 + /- 3.9 g with hydrolyzed casein and 27.2 + /- 3.5 g in soyfed patients . CONCLUSIONS It is suggested that the diets with different protein content used in subjects with CMPA did not determine any difference in the stimulation of proteolytic and lipolytic pancreatic enzymes",
"Background Immunologic development of soy-fed infants has not been extensively studied . Early studies of soy flour – based formulas showed decreased immunoglobulin production when soy protein intake was limited . However , there were no significant differences in rotavirus vaccine responses between breast-fed and soy protein isolate – based formula-fed infants . Nucleotides added to milk-based formula benefit infant immune status , but reports of the immunologic effects of adding nucleotides to soy-based formula are not available . This study evaluated immune status and morbidity of infants fed soy protein isolate formulas with and without added nucleotides for 1 year . Methods Newborn , term infants enrolled in a masked 12-month feeding trial were assigned r and omly to groups fed soy formula with or without added nucleotides ( n = 94 , n = 92 ) . A nonr and omized human milk/formula cohort ( n = 81 ) was concurrently enrolled . Recommended immunizations were administered at 2 , 4 , and 6 months . Immune status was determined from antibody responses to Haemophilus influenzae type b , tetanus , diphtheria , and poliovirus vaccines at 6 , 7 , and 12 months . Parents and physicians reported morbidity data . Results All vaccine responses were within normal ranges . No response differences were observed between infants fed soy formula and those fed nucleotide-supplemented soy . However , antibody to H. influenzae type b at 7 and 12 months was higher in infants fed nucleotide-supplemented soy than in infants fed human milk/formula ( P = 0.007 , P = 0.008 , respectively ) . Human milk/formula-fed infants had higher poliovirus neutralizing antibody at 12 months than did soy-fed infants ( P = 0.016 ) . Morbidity analyses showed that only physician-reported diarrhea was different among groups ( groups fed human milk/formula had less diarrhea than did soy groups , P = 0.011 ) . Conclusions Term infants fed soy protein isolate – based formulas have normal immune development as measured by antibody responses to childhood immunizations",
"Abstract Objectives : To investigate the association between the duration of exclusive breast feeding and the development of asthma related outcomes in children at age 6 years . Design : Prospect i ve cohort study . Setting : Western Australia . Subjects : 2187 children ascertained through antenatal clinics at the major tertiary obstetric hospital in Perth and followed to age 6 years . Main outcome measures : Unconditional logistic regression to model the association between duration of exclusive breast feeding and outcomes related to asthma or atopy at 6 years of age , allowing for several important confounders : sex , gestational age , smoking in the household , and early childcare . Results : After adjustment for confounders , the introduction of milk other than breast milk before 4 months of age was a significant risk factor for all asthma and atopy related outcomes in children aged 6 years : asthma diagnosed by a doctor ( odds ratio 1.25 , 95 % confidence interval 1.02 to 1.52 ) ; wheeze three or more times since 1 year of age ( 1.41 , 1.14 to 1.76 ) ; wheeze in the past year ( 1.31 , 1.05 to 1.64 ) ; sleep disturbance due to wheeze within the past year ( 1.42 , 1.07 to 1.89 ) ; age when doctor diagnosed asthma ( hazard ratio 1.22 , 1.03 to 1.43 ) ; age at first wheeze ( 1.36 , 1.17 to 1.59 ) ; and positive skin prick test reaction to at least one common aeroallergen ( 1.30 , 1.04 to 1.61 ) . Conclusion : A significant reduction in the risk of childhood asthma at age 6 years occurs if exclusive breast feeding is continued for at least the 4 months after birth . These findings are important for our underst and ing of the cause of childhood asthma and suggest that public health interventions to optimise breast feeding may help to reduce the community burden of childhood asthma and its associated traits . Key messages Asthma is the leading cause of admission to hospital in Australian children and its prevalence is increasing Whether breast feeding protects against asthma or atopy , or both , is controversial Asthma is a complex disease , and the relative risks between breast feeding and asthma or atopy are unlikely to be large ; this suggests the need for investigation in a large prospect i ve birth cohort with timely assessment of atopic outcomes and all relevant exposures Exclusive breast feeding for at least 4 months is associated with a significant reduction in the risk of asthma and atopy at age 6 years and with a significant delay in the age at onset of wheezing and asthma being diagnosed by a doctor Public health interventions to promote an increased duration of exclusive breast feeding may help to reduce the morbidity and prevalence of childhood asthma and",
"OBJECTIVES To determine the prevalence of soy allergy in IgE-associated cow 's milk allergy ( CMA ) . STUDY DESIGN Children were evaluated for soy allergy by double-blind , placebo-controlled food challenge , open challenge , or convincing previous history of an anaphylactic reaction to soy . Children tolerant to soy at entry received soy formula and were followed up for 1 year . RESULTS Of this IgE-associated CMA cohort ( ages 3 to 41 months ) , 14 % ( 95 % CI = 7 . 7%-22.7 % ) were determined to have soy allergy , 12 definitely at entry and 1 possibly after 1 year of soy ingestion . The latter child experienced severe failure to thrive at enrollment and exhibited improved growth while receiving soy during follow-up but was diagnosed with eosinophilic esophagitis at study completion . Improved growth ( P soy formula ( 579 31 mL/d ) during the year of follow-up . CONCLUSIONS Soy allergy occurs in only a small minority of young children with IgE-associated CMA . As such , soy formula may provide a safe and growth-promoting alternative for the majority of children with IgE-associated CMA shown to be soy tolerant at the time of introduction of soy formula",
"A recent increase in the prevalence of atopic disorders and the enormous costs of management of atopic patients have prompted attempts at prevention . We have examined the effect of exclusive breast feeding and of feeding different infant formulas on incidence of atopic disease in a prospect i ve r and omized controlled study . Seventy-two infants were recruited into each of the following groups : cow milk whey hydrolysate formula ( NAN/HA ) conventional cow milk formula ( Similac ) , soy-based formula ( Isomil ) , and exclusive breast feeding for greater than 4 months . The cumulative incidence of atopic eczema , recurrent wheezing , rhinitis , gastrointestinal symptoms , and colic were noted . Skin prick tests and radioallergosorbent tests for IgE antibodies to milk and soy were performed . At 12 and 18 months of age , the incidence of atopic eczema as also that of all atopic symptoms was significantly lower and similar in the breast-fed and whey hydrolysate groups , compared with the cow milk and soy formula groups . IgE antibodies were detected more often in the cow milk and soy formula groups , especially the former . Among symptomatic infants , fewer skin positive prick tests were seen in the soy group compared with the cow milk group . Our observations show that among infants at high risk of developing atopic disease because of positive family history , exclusive breast feeding or whey hydrolysate formula is associated with a lower incidence and thus a delay in the occurrence of allergic disorders compared with groups fed conventional cow milk or soy formulas",
"BACKGROUND Allergy is a common cause of illness . The effect of feeding different infant formulas on the incidence of atopic disease and food allergy was assessed in a prospect i ve r and omized double-blind study of high-risk infants with a family history of atopy . METHODS 216 high-risk infants whose mothers had elected not to breast-feed were r and omized to receive exclusively a partial whey hydrolysate formula or a conventional cow 's milk formula or a soy formula until 6 months of age . Seventy-two high risk infants breast-fed for > or = 4 months were also studied . RESULTS Follow-up until 5 years of age showed a significant lowering in the cumulative incidence of atopic disease in the breast-fed ( odds ratio 0.422 [ 0.200 - 0.891 ] ) and the whey hydrolysate ( odds ratio 0.322 [ 0.159 - 0.653 ) groups , compared with the conventional cow 's milk group . Soy formula was not effective ( odds ratio 0.759 [ 0.384 - 1.501 ] ) . The occurrence of both eczema and asthma was lowest in the breast-fed and whey hydrolysate groups and was comparable in the cow 's milk and soy groups . Similar significant differences were noted in the 18 - 60 month period prevalence of eczema and asthma . Eczema was less severe in the whey hydrolysate group compared with the other groups . Double-blind placebo-controlled food challenges showed a lower prevalence of food allergy in the whey hydrolysate group compared with the other formula groups . CONCLUSIONS Exclusive breast-feeding or feeding with a partial whey hydrolysate formula is associated with lower incidence of atopic disease and food allergy . This is a cost-effective approach to the prevention of allergic disease in children",
"The determinants of wheezing and allergy were investigated in 453 children with a family history of allergic disease . A r and omised controlled trial examined the effects of withholding cows ' milk protein during the first three months of life and replacing cows ' milk with soya milk . The children were followed up to the age of 7 years . Withholding cows ' milk did not reduce the incidence of allergy or wheezing . Children who had ever been breast fed had a lower incidence of wheeze than those who had not ( 59 % and 74 % respectively ) . The effect persisted to age 7 years in the non-atopics only , the risk of wheeze being halved in the breast fed children after allowing for employment status , sex passive smoking , and overcrowding . Allergic disease was not associated with exposure to tobacco smoke , house dust mite antigen , or cats . Breast feeding may confer long term protection against respiratory infection",
" Forty‐eight children with a biparental history of atopic disease were followed from birth to 4 years of age . One group was fed soy and the other cow 's milk from weaning to 9 months of age . Two‐thirds of the children developed symptoms of atopic disease with no significant difference between the groups . No difference was found in the serum immunoglobulins ( IgE antibodies , IgA , IgG and IgM ) during the observation period . The soy fed children showed transiently lower levels of IgG antibodies to cow 's milk but higher levels of IgG antibodies to soy protein . Six children showed cow 's milk intolerance and a further five had symptoms possibly related to the use of cow 's milk . Withholding cow 's milk during the first 9 months did not reduce the incidence of symptoms of cow 's milk intolerance from birth to 4 years of age . Thus , no benefit was found from replacing cows ' milk with soy . A prolonged breast feeding seems most rational for infants at risk of developing atopic disease , even if the present study did not show evidence of a prophylactic effect of breast milk against the development of atopic disease ",
"BACKGROUND One hundred twenty children , identified before birth as being at high risk for atopy , were prenatally assigned to prophylactic or control groups . METHODS The infants in the prophylactic group either received breast milk from mothers on an exclusion diet or an extensively hydrolyzed formula . Their bedrooms and living rooms were treated repeatedly with an acaricide , and they used polyvinyl-covered mattresses with vented head areas . The infants in the control group were fed conventionally , and no environmental control was recommended . RESULTS A significant advantage , first demonstrated at 1 year of age , persists for children in the prophylactic group . They have less of any allergy or eczema , but the reduced prevalence of asthma is no longer significant . Only three children in the prophylactic group had positive skin prick test results compared with 16 in the control group , suggesting a significant reduction in sensitization . CONCLUSION A dual approach to allergen avoidance , focusing on foods and aeroallergens , appears to be beneficial in selected high-risk infants . Avoidance of potent allergens in early life increases the threshold for sensitization in these high-risk infants . Whether sensitization has been avoided or merely deferred has yet to be proved",
"IN 1953 Glaser and Johnstone1 reported on the use of soybean milk as an aid in the prophylaxis of allergic disease in children . They concluded that if one withheld cow 's milk , beef , egg and wheat from the diets of potentially allergic children from the time of birth until the age of six to nine months , only one quarter as many of these children acquired major respiratory allergies compared to their siblings and another nonrelated control group . They also reported that the incidence of atopic eczema in infants on the restricted diet was only one fourth as great as in the . .",
"The possible role of cows milk intolerance in the aetiology of infant colic was evaluated in 19 babies presenting to their health visitor or general practitioner in one town . Over a three week period a st and ard modified cows milk formula was compared with a soya milk formula on a double blind basis . The duration of colic symptoms was significantly reduced during the week on soya milk ( P less than 0.01 ) , with 11 out of 19 babies fulfilling the diagnostic criteria for cows milk intolerance . Four babies whose symptoms failed to improve either spontaneously or with soya milk were given a hydrolysed protein milk with a positive response in two , confirmed by challenge testing . Thus in 13 out of 19 babies ( 68 % ) the symptoms of infant colic resolved almost completely with dietary change",
"Background Infants fed a soy protein isolate – based formula have immunization responses similar to breast-fed infants . However , cellular aspects of the immunologic development of soy-fed infants have not been studied extensively . Nucleotides added to milk-based formula benefit infant immune status , but reports of the immunologic effects of adding nucleotides to soy-based formula are not available . This study examines immune cell population s of infants fed soy protein isolate formulas with and without added nucleotides for 1 year . Methods Newborn , term infants studied in a masked 12-month feeding trial were assigned r and omly to soy formula groups with and without added nucleotides ( n = 94 , n = 92 ) . A nonr and omized human milk/formula-fed cohort ( n = 81 ) , was concurrently enrolled . Blood sample s were collected at 6 , 7 , and 12 months . Thirty-two immune cell population s were characterized using three-color flow cytometry . Cellular markers were chosen to assess general pediatric immune status , emphasizing maturation and activation of B , T , and NK lymphocytes . Results All cell population s , number and percentages , were within age-related normal ranges . The only significant difference found between soy formula and human milk/formula-fed infants was the percentage of CD57 + NK T cells at 12 months ( human milk/formula > soy formula , P = 0.034 ) . There were significant differences at some time points between human milk/formula-fed and nucleotide-supplemented soy formula – fed infants in population s of lymphocytes , eosinophils , total T , helper T , naive helper , memory/effector helper , CD57−T , and CD11b+CD8+NK cells . None of the cell population s differed between infants fed soy formula versus soy plus nucleotides . Conclusions Infants fed this commercial soy formula demonstrated immune cell status similar to human milk/formula-fed infants , consistent with normal immune system development . The addition of nucleotides to soy formula did not significantly change specific individual immune cell population s but tended to increase numbers and percentages of T cells and decreased numbers and percentages of NK cells",
" Abstract . 1079 of 1548 newborn infants were followed during their first year . 328 were prospect ively contacted once a month . 751 were followed up at child welfare clinics . Altogether 20 were diagnosed as being cow 's milk protein intolerant ( 1.9 % ) . Symptoms from the gastrointestinal tract and the skin predominated . Only 2 had respiratory symptoms . Ten had their symtpoms within one week after the introduction of cow 's milk , 3 of them at their first cow 's milk‐containing meal . A further 4 already had symptoms when fed only human milk . The others ( 6 infants ) showed symptoms after more than one week on a cow 's milk containing diet . Before 2 years of age , 13 had recovered . Twelve of the cow 's milk protein intolerant infants also showed adverse reactions to other foods , soy‐protein intolerance being the most common ( 7 infants ) . A family history of allergy was found in 35 % ( 116 ) of the 328 infants and in 70 % ( 14 ) of those with cow 's milk protein intolerance",
"There is much evidence that the development of allergic disorders may be related to early exposure of allergens , including those in breastmilk . We have tried to find out whether avoidance of food and inhaled allergens in infancy protects against the development of allergic disorders in high-risk infants . In a prenatally r and omised , controlled study 120 infants with family history of atopy and high ( greater than 0.5 kU/l ) cord-blood concentrations of total IgE were allocated r and omly to prophylactic and control groups . In the prophylactic group ( n = 58 ) , lactating mothers avoided allergenic foods ( milk , egg , fish , and nuts ) and avoided feeding their infants these foods and soya , wheat , and orange up to the age of 12 months ; the infants ' bedrooms and living rooms were treated with an acaricidal powder and foam every 3 months , and concentrations of Dermatophagoides pteronyssinus antigen(Der p l ) in dust sample s were measured by enzyme-linked immunosorbent assay . In the control group ( n = 62 ) , the diet of mothers and infants was unrestricted ; no acaricidal treatment was done and Der p l concentrations were measured at birth and at 9 months . A paediatric allergy specialist unaware of group assignment examined the infants for allergic disorders at 10 - 12 months . Odds ratios were calculated by logistic regression analysis for various factors with control for other confounding variables . At 12 months , allergic disorders had developed in 25 ( 40 % ) control infants and in 8 ( 13 % ) of the prophylactic group ( odds ratio 6.34 , 95 % confidence intervals 2.0 - 20.1 ) . The prevalences at 12 months of asthma ( 4.13 , 1.1 - 15.5 ) and eczema ( 3.6 , 1.0 - 12.5 ) were also significantly greater in the control group . Parental smoking was a significant risk factor for total allergy at 12 months whether only one parent smoked ( 3.97 , 1.2 - 13.6 ) or both parents smoked ( 4.72 , 1.2 - 18.2 )",
"BACKGROUND The relationship between infant feeding and childhood asthma is controversial . This study tested the hypothesis that the relation between breast feeding and childhood asthma is altered by the presence of maternal asthma . METHODS Healthy non-selected newborn infants ( n=1246 ) were enrolled at birth . Asthma was defined as a physician diagnosis of asthma plus asthma symptoms reported on ⩾2 question naires at 6 , 9 , 11 or 13 years . Recurrent wheeze ( ⩾4 episodes in the past year ) was reported by question naire at seven ages in the first 13 years of life . Duration of exclusive breast feeding was based on prospect i ve physician reports or parental question naires completed at 18 months . Atopy was assessed by skin test responses at the age of 6 years . RESULTS The relationship between breast feeding , asthma , and wheeze differed with the presence or absence of maternal asthma and atopy in the child . After adjusting for confounders , children with asthmatic mothers were significantly more likely to have asthma if they had been exclusively breast fed ( OR 8.7 , 95 % CI 3.4 to 22.2 ) . This relationship was only evident for atopic children and persisted after adjusting for confounders . In contrast , the relation between recurrent wheeze and breast feeding was age dependent . In the first 2 years of life exclusive breast feeding was associated with significantly lower rates of recurrent wheeze ( OR 0.45 , 95 % CI 0.2 to 0.9 ) , regardless of the presence or absence of maternal asthma or atopy in the child . Beginning at the age of 6 years , exclusive breast feeding was unrelated to prevalence of recurrent wheeze , except for children with asthmatic mothers in whom it was associated with a higher odds ratio for wheeze ( OR 5.7 , 95 % CI 2.3 to 14.1 ) , especially if the child was atopic . CONCLUSION The relationship between breast feeding and asthma or recurrent wheeze varies with the age of the child and the presence or absence of maternal asthma and atopy in the child . While associated with protection against recurrent wheeze early in life , breast feeding is associated with an increased risk of asthma and recurrent wheeze beginning at the age of 6 years , but only for atopic children with asthmatic mothers",
"Background : Chronic diarrhea is the most common gastrointestinal symptom of intolerance of cow 's milk among children . On the basis of a prior open study , we hypothesized that intolerance of cow 's milk can also cause severe perianal lesions with pain on defecation and consequent constipation in young children . Methods : We performed a double-blind , crossover study comparing cow 's milk with soy milk in 65 children ( age range , 11 to 72 months ) with chronic constipation ( defined as having one bowel movement every 3 to 15 days ) . All had been referred to a pediatric gastroenterology clinic and had previously been treated with laxatives without success ; 49 had anal fissures and perianal erythoma or edema . After 15 days of observation , the patients received cow 's milk or soy milk for 2 weeks . After a one week washout period , the feedings were reversed . A response was defined as eight or more bowel movements during a treatment period . Results : Forty-four of the 65 children ( 68 percent ) had a response while receiving soy milk . Anal fissures and pain with defecation resolved . None of the children who received cow 's milk had a response . In all 44 children with a response , the response was confirmed with a double blind challenge with cow 's milk . Children with a response had a higher frequency of coexistent rhinitis , dermatitis , or bronchospasm than those with no response ( 11 of 44 children vs. 1 of 21 , P = 0.05 ) ; they were also more likely to have anal fissures and erythema or edema at base line ( 40 of 44 vs. 9 of 21 , P inflammation of the rectal mucosa on biopsy ( 26 of 44 vs. 5 of 21 , P = 0.008 ) , and signs of hypersensitivity , such as specific IgE antibodies to cow's-milk antigens ( 31 of 44 vs. 4 of 21 , p In young children , chronic constipation can be a manifestation of intolerance of cow 's milk",
"The effect of withholding cows ' milk was examined in 487 infants at high risk of allergic disease . Before birth they were r and omly allocated either to a control group , most of whom received cows ' milk preparations , or to an intervention group , who were offered a soya based substitute . Eczema and wheezing occurred to a similar extent in the two groups during the first year of life , although napkin rash , diarrhoea , and oral thrush were commoner in the intervention group , especially during the first three months . Breast feeding for any length of time was associated with a reduced incidence of wheezing and diarrhoea",
"BACKGROUND Cow 's milk allergy ( CMA ) is a common disease of infancy and childhood . An appropriate cow 's milk ( CM ) substitute is necessary for feeding babies with CMA . CM substitutes are soy formulas and casein- or whey-based extensively hydrolyzed formulas . In several countries , including Italy , goat 's milk ( GM ) formulas are available , and some physicians recommend them for feeding babies with CMA . OBJECTIVE We sought to investigate , in vitro and in vivo , the allergenicity of GM in 26 children with proven IgE-mediated CMA . METHODS All the children underwent skin tests with CM and GM ; detection of specific serum IgE to CM and GM ; and double-blind , placebo-controlled , oral food challenges ( DBPCOFCs ) with fresh CM , GM , and , as placebo , a soy formula ( Isomil , Abbott , Italy ) . CAP inhibition and immunoblotting inhibition assays were also carried out in 1 of 26 and 4 of 26 children with positive RAST results to both CM and GM , respectively . RESULTS All the children had positive skin test responses and CAP results to both CM and GM , all had positive DBPCOFC results to CM , and 24 of 26 had positive DBPCOFCs to GM . In CAP inhibition tests , preincubation of serum with CM or GM strongly inhibited IgE either to CM or to GM . In immunoblotting inhibition assays , preincubation with CM completely extinguished reactivity to GM , whereas GM partially inhibited reactivity to CM . CONCLUSIONS These data strongly indicate that GM is not an appropriate CM substitute for children with IgE-mediated CMA . A warning on the lack of safety of GM for children with CMA should be on the label of GM formulas to prevent severe allergic reactions in babies with CMA",
" This study examined 120 infants , aged 3–12 weeks , with severe colics and compared the results of a specific hypoallergenic diet ( group A ) with those of pharmacological treatment ( group B ) . Non‐breastfed group A infants received soy milk and if unresponsive , hydrolyzed milk formulas ; mothers of breast‐fed infants received a diet without cow 's milk , eggs or fish . Breast‐fed and non‐breast‐fed group B infants received dicyclomine hydrochloride 3 mg/kg/day . Results , based on quantitative measurements of crying . indicated that in breast‐fed infants there was no significant improvement between group A ( 62.5 % ) and group B ( 66.6 % ) infants . Among formula‐fed infants , comparison of positive results using soy milk ( 65.9 % ) with positive results using dicyclomine ( 53.3 % ) was not significant ; positive results using soy milk and hydrolyzed milk formulas in non‐responders to soy milk , provided an improvement in 95.4 % of cases . Pharmacological treatment provided an improvement in 53.3 % ) of cases . The diffcrence was significant ( p<0.01 )",
"OBJECTIVE Palm and palm olein ( PO ) oils are used in some infant formula fat blends to match the fatty acid profile of human milk , but their presence has been shown to lower calcium and fat absorption . We aim ed to determine if the reported differences in calcium absorption could affect skeletal development by comparing bone mineral accretion in healthy term infants fed a milk-based formula with ( PMF ) or without PO . METHODS Whole body bone mineralization was evaluated in healthy term infants fed 1 of 2 coded , commercially available , ready-to-feed infant formulas in a r and omized , double-blind , parallel study . Subjects were fed either 1 ) . PMF formula ( Enfamil with iron ; Mead Johnson Division of Bristol Myers , Evansville , IN ; N = 63 ) containing PO/coconut/soy/high-oleic sunflower oils ( 45/20/20/15 % oil ) ; or 2 ) . milk-based formula without PO ( Similac with iron ; Ross Products Division Abbott Laboratories , Columbus , OH ; N = 65 ) , containing high-oleic safflower/coconut/soy oils ( 40/30/30 % oil ) from enrollment by 2 weeks after birth until 6 months . Anthropometrics and formula intake were determined monthly ; total body bone mineral content ( BMC ) and bone mineral density ( BMD ) were measured at baseline , 3 , and 6 months of age using dual energy x-ray absorptiometry . RESULTS Intent-to-treat analyses indicated no significant differences between feeding groups in weight , length , head circumference , or formula intake throughout the study . BMC and BMD were not different at baseline but repeated measures analyses show that infants fed PMF had significantly lower BMC and BMD at 3 and 6 months . CONCLUSIONS Healthy term infants fed a formula containing PO as the predominant oil in the fat blend had significantly lower BMC and BMD than those fed a formula without PO . The inclusion of PO in infant formula at levels needed to provide a fatty acid profile similar to that of human milk leads to lower bone mineralization",
"Background : In patients with cow 's milk protein intolerance ( CMPI ) , delayed clinical reactions to cow 's milk ( CM ) ingestion may be misdiagnosed if the clinical symptoms are not “ classical ” and there is a long time lapse between ingestion of CM and the clinical reaction . The aim was to evaluate the clinical outcome of CMPI in a cohort of CM‐intolerant children , with particular attention to the occurrence of clinical manifestations beyond 72 h after CM challenge ",
"The aim of the study was to compare , during the first month of life , growth parameters , biochemical indices of protein metabolism and plasma amino acid concentrations in newborn infants fed either human milk ( n = 23 ) , three different whey hydrolysate formulae ( WHF 1 , n = 13 ; WHF 2 , n = 10 ; WHF 3 , n = 13 ) , a soy-collagen hydrolysate formula ( SCHF n = 18 ) or a whey-casein hydrolysate formula ( WCHF , n = 20 ) . Growth parameters and the various protein concentrations determined in the infants fed WHF 1 and WHF 2 were similar to the values observed with human milk . With WHF 3 , growth in weight , length and head circumference and serum total protein concentrations were reduced significantly whereas blood urea nitrogen was increased . With SCHF , growth in weight and length as well as serum total protein and transferrin concentration were decreased significantly , whereas serum IgG concentration was increased . With WCHF growth in length and serum transferrin concentration were decreased compared to the human milk group . In the various groups , the plasma amino acid pattern reflected the amino acid content of the formula . Whey hydrolysate formula induced mainly an increase in threonine and a decrease in tyrosine concentrations . Soy-collagen hydrolysate formula led to an increase of non-essential amino acids , such as glycine and hydroxyproline , and a decrease in plasma lysine and cystine . Whey-casein hydrolysate formula induced a plasma amino acid pattern close to the profile observed with human milk . Nevertheless , the plasma concentrations of most of the various amino acids were higher . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Objective : Quantitative balance studies were performed to compare fat and calcium absorption in healthy , full term infants fed casein hydrolysate-based ( CHF ) and soy protein-based ( SPF ) infant formulas with or without palm olein ( PO ) . Previous studies have reported that PO significantly reduced absorption of both fat and calcium in cow ’s milk-based formulas in which most of the calcium is inherent in the milk protein . In both SPF and CHF virtually all calcium is added as calcium salts . Methods : Two r and omized , blinded , crossover balance studies were conducted in normal term infants using a three-day home balance method . One study evaluated 10 infants fed commercially available CHF with or without PO , and the other study evaluated 12 infants fed commercially available SPF with or without PO . Fat and calcium absorption were determined based on the weight of formula intake , weight of stools , and measured calcium and fat in formula and stools . Results : Fat and calcium intake did not differ between the groups fed CHF . However , infant ’s calcium and fat absorption was less , 41 ± 6 % ( Mean ± SEM ) and 92.0 ± 0.8 % , respectively , when fed CHF with PO compared to 66 ± 5 % and 96.6 ± 1.1 % , respectively , when fed CHF without PO , ( p , fat and calcium intake did not differ between the feeding groups . Mean calcium absorption was also significantly less when infants were fed SPF with PO , 22 ± 3 % , than when fed SPF with no PO , 37 ± 4 % ( p 0.05 ) . Fat absorption did not differ between the two SPFs . Conclusion : This study demonstrates that PO , as the predominant fat , is associated with significantly lower absorption of calcium from infant formulas in which calcium salts are the source of calcium . These findings corroborate previous reports of this negative effect of PO in cow milk-based infant formulas in which most of the calcium is a component of the cow milk protein source",
"One hundred and sixty‐two women with respiratory allergy to animal d and ers and /or pollens were r and omly allocated to a diet consisting of either a very low ingestion of hens ' egg and cows ' milk or a daily ingestion of one hens ' egg and about 11 of cows ' milk during the last 3 months of pregnancy . One hundred and sixty‐three infants were followed prospect ively up to 18 months of age when the cumulated incidence of atopic disease in each child was evaluated blindly . No significant differences in the distribution of atopic disease were found among the infants in relation to the maternal diet during late pregnancy . The numbers of skin‐prick tests positive to ovalbumin , ovomucoid , β‐lactoglobulin and cows ' milk were likewise not influenced by differences in the maternal diet during late pregnancy . Genetic factors rather than maternal diet during the perinatal period probably have a greater effect on the incidence of atopic diseases during early infancy",
"Growth parameters , biochemical indice of protein metabolism and plasma Amino acid ( AA ) concentrations were investigated during the first month of life in term infants ( n = 61 ) fed various protein hydrolysate formulas ( whey ( WHF , n = 3 ) , soy collagen ( SCHF , n = 1 ) and whey-casein hydrolysate formulas ( WCHF , n = 1 ) ) . In addition , metabolic balance studies were performed in 10 infants fed WHF and in 5 fed WCHF . Comparatively to breast fed infants , growth reduction and decrease in plasma protein concentrations were observed with the use of one of the WHF and in a lesser extent with the SCHF and the WCHF . Plasma amino acid pattern reflected the AA content of the formulas . Whey hydrolysate formulas induced mainly an increase in threonine and a decrease in tyrosine concentrations . Soy-collagen hydrolysate formula led to an increase of non-essential amino acids , such as glycine and hydroxyproline and a decrease in plasma lysine and cystine . Whey-casein hydrolysate formula induced a plasma amino acid pattern close to the profile observed in breast fed infant . Metabolic balance studies showed a relative reduction in nitrogen absorption and utilisation in the infants fed the WHF and the WCHF . In addition a drastic reduction in fat , calcium and phosphorus absorption was also observed with the use of the WCHF . In preterm infants ( n = 19 ) fed whey predominant hydrolysed preterm formulas ( n = 3 ) , metabolic balance studies an plasma AA concentration were evaluated at the end of the first month of life at 34 weeks of gestation age . Comparatively to similar preterm infants fed conventional preterm formulas , a relative reduction in nitrogen absorption ( 83 % vs 90 % ) and retention ( 64 vs 70 % ) as well as in phosphorus absorption ( 78 vs 89 % ) was observed . Calcium retention was similar ( 48 vs 45 mg/kg/d ) but calcium intake was significantly higher in infants fed hydrolysate formulas 120 vs 91 mg/kg/d . Plasma amino acid concentrations were related to amino acid composition of the formulas . Compared with the st and ard preterm formulas , all three protein hydrolysate formulas led to a significant increase in plasma threonine and a decrease in tyrosine and phenylalanine concentrations . In addition , there was a reduction in plasma histidine , valine , leucine , cystine , methionine and /or tryptophane with some of the hydrolysate formulas used . In conclusion , these studies provide evidence that protein hydrolysed formulas are not equivalent to whole protein formulas in terms of nutritional efficiency for preterm and term infants . Therefore further extensive nutritional studies on growth , biochemical indices of protein metabolism and metabolic balance , including minerals and trace elements , appear to be necessary before maintaining and promoting the use of such formulas for teh potential benefits on atopic disease in preterm and in full-term newborn infants",
"The soybean protein isolate used in powdered soybean formula is hydrolyzed more extensively than the isolate which is used in liquid soybean formula in most commercial soybean formulas . Previous in vitro studies have shown differences in human antibody response to these soybean protein isolates . Therefore , a prospect i ve clinical study was undertaken to determine if there were differences in adverse reaction rates to these soybean protein isolates . Forty-three patients with possible milk- and /or soy-protein enterocolitis were enrolled in this study . Patients had 3 separate oral food challenges ; using milk formula , soybean powder formula and soybean liquid formula . Ten ( 23 % ) patients challenged with milk had positive challenges . Fourteen ( 33 % ) patients challenged with powdered soy formula had positive challenges while thirteen ( 30 % ) challenged with liquid soy formula had positive challenges . In the 10 patients with positive milk challenges , 6 ( 60 % ) had a positive soy challenge . In the group with positive soy challenges , 5 reacted to the powdered soy challenge done first , but not the second challenge with the liquid soy formula , and 4 patients reacted to the liquid soy formula challenge done first , but not the second challenge with the powdered soy formula . These results indicate that a significant number of patients with milk protein enterocolitis have soy protein enterocolitis . In addition , an order effect can be demonstrated in the soy challenges because of the tendency to react to the first soy challenge regardless of the type of isolate . These results suggest that a local immune effect caused by the protein may be present",
"It has been reported that the feeding of cow 's milk may enhance the development of atopy in predisposed infants . A prospect i ve study following children from birth through 15 years of age in a private pediatric practice was design ed to determine if the food ingested during the first months of life is related to the development of atopy in the offspring of allergic families . Each of 328 children with a positive family history of allergy was assigned to one of three groups . according to the feeding preference of the parents : 48 were fed breast milk ; 79 , soy-based formula ; and 201 , cow 's milk formula . All groups had egg , citrus , tomato , and wheat restrictions as well as inhalant allergen avoidance . These were compared to a control group of 580 children with no family history of allergy . Breast fed infants were found to have approximately one-half the incidence of atopy of cow 's milk or soy formula fed infants from atopic families when followed for up to 15 years . Soy feeding produced no advantage over cow 's milk in the prophylaxis of allergic disease . There was a threefold increase in clinical ly apparent atopic disease in offspring of allergic families when compared to controls but only a two-fold increase if the infant was breast fed . These results support the hypothesis that breast feeding and delay of exposure to known allergens may reduce the frequency of clinical allergic disease in the offspring of allergic families",
"OBJECTIVE The objective of this study was to examine the effects of soy formulas with and without added soy fiber in children who developed diarrhea while receiving antibiotics . DESIGN In a masked , r and omized parallel study , older infants and toddlers were fed commercial soy formulas with or without added soy fiber for 10 days on occurrence of diarrhea during the administration of antibiotics . Subjects were stratified by feeding ( formula versus cow 's milk ) . The primary variables were duration of diarrhea , stool characteristics , and intake . Secondary variables were weight and spit-up . RESULTS All 45 children who completed the 10-day study received > 30 % of their caloric intake from formula . Fiber intake from other foods did not differ between groups and averaged 0.5 g/day . Total median fiber intake of the group fed the formula with added fiber was 6.53 g/day . The mean duration of diarrhea was 25.1 + /- 5.2 hours for children fed the formula with added fiber and 51.6 + /- 10.7 hours for those fed the regular formula ( P = .0013 ) . CONCLUSION The duration of antibiotic-induced diarrhea in children fed the soy formula with added soy fiber was significantly reduced",
"The effect of feeding different infant formulas on incidence of atopic disease was assessed in a prospect i ve double-blind r and omized controlled trial among \" high risk \" infants with family history of atopy among first-degree relatives . The incidence of atopic eczema , wheezing , rhinitis , gastrointestinal symptoms , and colic was noted and serum IgE antibodies to milk were estimated . Seventy-two infants were recruited into each of the following groups : cow milk whey hydrolysate formula ( NAN/HA ) , conventional cow milk formula ( Similac ) , soy-based formula ( Isomil ) , and exclusive breast feeding for greater than or equal to 4 months . The number of infants who exited for reasons other than atopy and were excluded from analysis were 4 , 5 , 4 , and 12 in the four groups , respectively . The incidence of one or more symptoms of possible allergic etiology was five of 68 infants fed NAN/HA , 24 of 67 infants fed Similac , 25 of 68 infants fed Isomil , and 12 of 60 breast-fed infants . Among symptomatic infants , skin prick test to milk proteins was positive in four out of five infants fed NAN/HA , 16 of 24 fed Similac , 2 of 25 fed Isomil , and 7 of 12 breast-fed . IgE antibodies to milk were found in 2 of 68 , 9 of 67 , 0 of 68 , and 6 of 60 infants in the four groups , respectively . It is concluded that exclusive breast feeding for more than 4 months is partially protective against the development of atopic disease among high risk infants . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE The purpose of this study was to compare growth and protein status of healthy term infants from 2 to 112 days of age fed a commercially available soy-based formula ( IS ) and a similar formula ( EF ) containing less protein ( 2.91 vs 2.45 g/100 kcal ) . DESIGN A controlled , r and omized , blind parallel clinical trial was conducted in 32 male and 32 female infants . Infants were enrolled at 2 days of age , and their assigned formula was their only feeding to 112 days of age . At this time their weight , length , and head circumference were measured . Weight , length , and head circumference were measured and formula intake , formula intolerance and stool characteristics were recorded at 8 , 28 , 56 , and 112 days of age . Plasma urea nitrogen ( PUN ) , total protein , albumin , and transthyretin were determined at 56 and 112 days . RESULTS There were no statistically significant differences in weight , length , head circumference , or gains in these measures . PUN concentration was significantly lower in infants fed EF than IS at 56 and 112 days . Plasma total protein , albumin , and transthyretin concentrations were not different between the two feeding groups at the two testing periods . Tolerance to the two formulas was similar . Stool characteristics did not differ between the two groups . CONCLUSION A soy-based formula containing 2.45 g protein/100 kcal and approximately 640 mumol of total sulfur containing amino acids/100 kcal adequately meets the protein needs of term infants from 2 to 112 days of age",
"Treating the infant colic syndrome by counseling the parents concerning more effective responses to the infant crying is compared to the elimination of soy or cow 's milk protein from the infant 's diet in a r and omized clinical trial . Because symptoms of vomiting and diarrhea are not part of the infant colic syndrome , infants with these gastrointestinal symptoms were excluded from the study . Dietary changes were accomplished by either feeding the infants a hydrolyzed casein formula or by requiring mothers to eliminate milk from their diets . In phase 1 of the study , the group receiving counseling ( n = 10 ) had a decrease in crying from 3.21 + /- 1.10 h/d to 1.08 + /- 0.70 h/d ( P = .001 ) . The crying in the group that received dietary changes ( n = 10 ) decreased from 3.19 + /- 0.69 h/d to 2.03 + /- 1.07 h/d ( P = .01 ) , a level still greater than twice normal . The decrease in those receiving counseling was faster and greater than that of those given dietary changes ( P less than .02 ) . In the second phase of the study , group 2 infants were reexposed to cow 's milk or soy protein and the parents received counseling . In this phase , counseling again decreased crying significantly from 2.09 + /- 1.07 h/d to 1.19 + /- 0.60 h/d ( P = .05 ) . No infant in the study who improved with changes in his or her diet had a significant increase in crying , with reexposure to soy or cow 's milk protein . ( ABSTRACT TRUNCATED AT 250 WORDS",
" Infants ( n = 18 ) with intolerance to extensively hydrolyzed formulas and soy who responded to an L-amino acid-based elemental formula ( AAF ) were studied until 3 years of age . By 2 years of age most tolerated non-formula foods , and by 3 years only 3 required AAF . Growth normalized during AAF feeding in 4 infants with failure to thrive",
"The protective effect of breast feeding against atopic disease ( AD ) has been confirmed in several prospect i ve studies , while some retrospective studies have yielded controversial results . We have evaluated the prophylactic effect of prolonged breast feeding on the development of AD in 101 newborns at hereditary risk for allergic disease . The study design also included a strict dietary avoidance regimen of the nursing mothers . Our data demonstrate that breast feeding or breast feeding supplemented with soy milk exert a prophylactic effect on the development of AD in these at-risk infants . Mechanisms by which breast feeding protects from atopy are discussed",
"For 16 years the double-blind , placebo-controlled food challenge ( DBPCFC ) has been used at the National Jewish Center for Immunology and Respiratory Medicine to determine whether adverse reactions to foods do occur in children . The objective of these studies was to explore these reproducible adverse reactions and to characterize them . Although skin testing was performed on all subjects , a history of an adverse reaction to food and to subsequent DBPCFC were the only criteria for entry into this study . Of 480 children studied , 185 ( 39 % ) have had positive DBPCFC results . In these 480 children , 245 ( 24 % ) of 1014 DBPCFCs showed positive results . Egg , peanut , and cow milk accounted for 73 % of the positive DBPCFC reactions , but many foods produced reactions . Skin test results were positive in most children with a positive DBPCFC reaction , but the large number of patients with asymptomatic hypersensitivity limited the accuracy of a positive skin test result alone as a predictor of clinical symptoms during food ingestion . Evaluation of results in this large number of children for a prolonged period revealed reproducible patterns of symptoms , timing , and incriminated foods . Placebo reactions were rare . The procedure was safe . Twelve youngsters with a negative DBPCFC result subsequently had positive reactions to open challenges when large amounts of the challenge food were used . In each of these cases the reactions were limited to areas of direct contact with the food or could be explained by the larger amount of food ingested during the open challenge . Multiple food hypersensitivity has been a rare finding . The DBPCFC should be the \" gold st and ard \" for both research and clinical diagnostic evaluations until it is superseded by methods that have yet to be developed",
"For a minimum of one month ( mean , 54 days ) , 287 infants and children less than 8 years of age were fed an isolated soy-protein formula . Prior to entry into the study , a cow 's milk formula was being fed to 71 % , a soy formula to 9 % , and cow 's milk or other formulas to 20 % . Intolerance to cow 's milk was reported in 35 % of the patients , symptoms indicative of cow 's milk intolerance in 23 % , diarrhea or gastroenteritis in 18 % , a family history of allergy in 13 % , and insufficient weight gain , intolerance to other formulas , or constipation in 11 % . The patients showed normal increases in weight and length during the study . A significant decrease in the following symptoms were reported in the patients from before to after treatment : abdominal cramps , bloating or gas , colic , diarrhea , fussiness , rashes or eczema , spitting up , waking up crying at night , wheezing , and vomiting . It is concluded that , while receiving soy formula , infants and children continued to thrive normally and that the formula was well tolerated . After receiving soy formula , the frequency of undesirable feeding-related symptoms was reduced in the majority of infants and children",
"In an attempt to prevent or reduce the manifestations of atopic disease , a group of infants considered to be genetically at high risk of atopy was entered in a prenatally r and omized , controlled study . A prophylactic group ( n= 58 ) was either breast‐fed with their mothers excluding foods regarded as highly antigenic from their diets , or given an extensively hydrolysed formula . In addition , strenuous efforts were made to reduce exposure to the house‐dust mite by application of acaricide to the bedroom and living room carpets and upholstered furniture . A control group ( n= 62 ) was fed conventionally by breast or on formula , and no specific environmental measures were taken . The results ( previously reported ) after 1 year showed significantly less total allergy , asthma , and eczema in the prophylactic group . Similar results were obtained at 2 years although the reduction in asthma no longer achieved statistical significance . However , there was significantly less sensitization , as shown by a battery of skin prick tests ( SPTs ) , to both dietary allergens and aeroallergens in the prophylactic group . A11 the children have now been review ed at the age of 4 years , and SPTs to a wide range of dietary allergens and aeroallergens have been performed . The control group continues to show more total allergy ( odds ratio [ OR ] 2.73 , 95 % confidence interval [ CI ] 1.21–6.13 , P definite allergy ( allergic symptoms plus positive SPT ) ( OR 5.6 , CI 1.8–17.9 , P and eczema ( OR 3.4 , CI 1.2–10.1 , P positive SPTs ( OR 3.7 , CI 1.3–10.0 , P reduces the risk of atopic disease . This should be reserved for infants considered at very high risk of atopy , and close medical and dietetic supervision must be available",
"The role of cow 's milk in infantile colic in formula-fed infants was estimated in a double-blind study . Sixty colicky infants were given a cow 's milk-containing formula ( Enfamil ) and a cow 's milk-free formula based on soy ( ProSobee ) . Eleven infants ( 18 % ) were free of symptoms while receiving soy formula . Symptoms of 32 infants ( 53 % ) were unchanged or worse when they were fed cow 's milk formula and soy formula , but symptoms disappeared when they were fed a formula containing hydrolyzed casein ( Nutramigen ) . Symptoms of 17 infants ( 29 % ) could not be related to the diet ; these infants were permitted to continue on a cow 's milk-based formula . A challenge with cow 's milk-based formula after one month ( at approximately age 3 months ) produced symptoms of infantile colic in 22 infants ( 36 % ) . At age 6 months , a challenge with cow 's milk was positive in 11 infants ( 18 % ) with epidermal and gastrointestinal symptoms . Eight infants ( 13 % ) at 12 months of age and five infants ( 8 % ) at 16 months of age were still intolerant to cow 's milk . Cow 's milk seems to be a major cause of infantile colic in formula-fed infants . A dietary treatment is suggested for moderate or severe forms of the colic . Cow 's milk protein intolerance is common later in infancy in these infants",
"STUDY OBJECTIVE : To identify environmental determinants of six symptoms associated with allergic disease in infancy . DESIGN : Infants were participants in a prospect i ve r and omised controlled trial of feeding practice s in families with a history of atopy . SETTING : Infants were recruited in two maternity hospitals in S Wales and followed up in the community for 1 year . PARTICIPANTS : Mothers of 519 infants agreed to participate , but 36 were excluded ( mainly for moving home or failing to attend for follow-up ) , leaving 483 in the study ( 253 male , 230 female ) . Infants were followed up and examined for evidence of allergic disease at 3 , 6 , and 12 months . MEASUREMENTS AND MAIN RESULTS : At each examination , mothers were question ed about episodes of illness in the infant , and the data presented relate to ( reported and observed ) eczema and nasal discharge , and ( reported ) wheeze , prolonged colds , diarrhoea and vomiting . Mothers kept a diary with details of feeding for the first 6 months . All homes were visited by a nurse who took sample s of dust for dust mite antigen analysis . Extensive socio-demographic data were collected . None of the factors studied showed a convincing relationship with eczema . In a multiple logistic regression analysis breast feeding appeared to protect against wheeze , nasal discharge , colds , vomiting and diarrhoea . Having more siblings increased the likelihood of prolonged colds , and ( together with overcrowding ) of wheeze and nasal discharge . Maternal smoking and low social class were associated with wheeze , and house dust antigen with prolonged colds . Respiratory symptoms were associated with some aspects of housing but these could not be distinguished clearly from other social factors . Babies born in Autumn were at increased risk of wheeze , vomiting and diarrhoea . CONCLUSIONS : Environmental factors play an important part in determining risk of symptoms in potentially atopic babies . These factors are in principle open to manipulation",
"OBJECTIVES We conducted a prospect i ve , r and omized study to evaluate the cumulative incidence of allergy or other adverse reactions to soy formula and to extensively hydrolyzed formula up to the age of 2 years in infants with confirmed cow 's milk allergy . STUDY DESIGN Infants ( n = 170 ) with documented cow 's milk allergy were r and omly assigned to receive either a soy formula or an extensively hydrolyzed formula . If it was suspected that the formula caused symptoms , a double-blind , placebo-controlled challenge ( DBPCFC ) with the formula was performed . The children were followed to the age of 2 years , and soy-specific immunoglobulin E antibodies were measured at the time of diagnosis and at the ages of 1 and 2 years . RESULTS An adverse reaction to the formula was confirmed by challenge in 8 patients ( 10 % ; 95 % confidence interval , 4.4%-18.8 % ) r and omly assigned to soy formula and in 2 patients ( 2.2 % ; 95 % confidence interval , 0.3 % to 7.8 % ) r and omly assigned to extensively hydrolyzed formula . Adverse reactions to soy were similar in IgE-associated and non-IgE-associated cow 's milk allergy ( 11 % and 9 % , respectively ) . IgE to soy was detected in only 2 infants with an adverse reaction to soy . Adverse reactions to soy formula were more common in younger ( Soy formula was well tolerated by most infants with IgE-associated and non-IgE-associated cow 's milk allergy . Development of IgE-associated allergy to soy was rare . Soy formula can be recommended as a first-choice alternative for infants > or=6 months of age with cow 's milk allergy",
"BACKGROUND Distinct wheezing disorders co-exist in young ( preschool ) children , some of which ( early transient wheeze and viral wheeze ) are thought to be unrelated to atopy . Investigation of changes in prevalence of wheezing disorders in preschool children could provide important clues about underlying mechanisms responsible for increasing prevalence of asthma in schoolchildren . METHODS Repeated population surveys of the prevalence of respiratory symptoms were done by parent-completed postal question naires in r and om sample s of 1650 ( 1990 ) and 2600 ( 1998 ) caucasian children aged 1 - 5 years living in the county of Leicestershire , UK . FINDINGS The response rates were 86 % ( 1422 of 1650 ) in 1990 and 84 % ( 2127 of 2522 ) in 1998 . Between 1990 and 1998 , there was a significant increase in the prevalance of reported wheeze ever ( 16 % to 29 % , p current wheeze ( 12 % to 26 % , p diagnosis of asthma ( 11 % to 19 % , p treatment for wheeze ( 15 % to 26 % , p admission for wheeze or other chest trouble ( 6 % to 10 % , p transient early wheezers ( 3 % to 5 % ) , persistent wheezers ( 5 % to 13 % ) , and late-onset wheezers ( 6 % to 8 % ) , and in all severity groups . The increase could not be accounted for by putative household risk factors because these declined between the 2 years . INTERPRETATION The fact that all preschool wheezing disorders increased ( including viral wheeze ) makes it probable that factors unrelated to atopy are implicated in the changing epidemiology of wheeze in childhood",
"Retraction On 28 October 2015 , The BMJ retracted this article , published in 1989 : Ch and ra RK , Puri S , Hamed A. Influence of maternal diet during lactation and use of formula feeds on development of atopic eczema in high risk infants . BMJ 1989;299:228–30 . The BMJ has retracted the article after receiving a copy of an inquiry into the research of R K Ch and ra , which was conducted by the Memorial University of Newfoundl and and completed in August 1995 . The university did not publish the inquiry report at the time . Nor did it notify the editors of journals that had published articles by Ch and ra that were considered in the report . The BMJ obtained a copy of the report when it came into the public domain as a result of Ch and ra taking and losing a legal action against the Canadian Broadcasting Corporation ( CBC ) , which aired television programmes about Ch and ra in 2006 . The inquiring committee experienced great difficulty with its work , but its final conclusion was that “ scientific misconduct has been committed by Dr Ch and ra . ” It looked at three studies and found that : “ absolutely no raw data ( or files ) of any kind were exhibited ” “ the Committee can not identify anyone who did the recruiting , can not identify anyone who did or remembers a significant amount of work ” “ the coauathors had little or very likely nothing to do with the work ” “ it is unbelievable that there are essentially no hospital records to support the study in question ” “ the committee can not accept that the Carnation study was done anywhere near to completeness or with the accuracy reported in the Annals of Allergy and Journal of Clinical Nutrition , For that matter , the same can probably be said for the Mead Johnson work published in the British Medical Journal . ” When asked by The BMJ in 2015 why it had not published the report in 1995 , Memorial University of Newfoundl and said that the report “ was the product of a flawed investigation process and could not be relied upon . ” In the CBC programmes , however , a university spokesman said that the university had not acted on the report because of legal threats from Ch and ra . The university further told The BMJ : “ In the spirit of being helpful , we acknowledge that over the years serious questions have been raised about the 1989 publication , leading to much controversy . If [ The ] BMJ decides to retract the paper on the basis of evidence apart from the findings of the 1995 report , then we would underst and your decision in this regard . ” The BMJ is retracting the paper because of the 1995 report , and because of the convincing evidence given in the CBC television programmes and the court case that the work of R K Ch and ra is not to be trusted . For more information , see The BMJ 's feature article(1 ) and editorial,(2 ) published on 28 October 2015"
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AIMS Evidence to support dietary modifications to improve glycemia during pregnancy is limited , and the benefits of diet beyond limiting gestational weight gain is unclear . Therefore , a systematic review and network meta- analysis of r and omized trials was conducted to compare the effects of various common diets , stratified by the addition of gestational weight gain advice , on fasting glucose and insulin , hemoglobin A1c ( HbA1c ) , and homeostatic model assessment for insulin resistance ( HOMA-IR ) in pregnant women . METHODS MEDLINE , EMBASE , Cochrane data base , and reference lists of published studies were search ed through April 2017 . R and omized trials directly comparing two or more diets for ≥2-weeks were eligible . Bayesian network meta- analysis was performed for fasting glucose . Owing to a lack of similar dietary comparisons , a st and ard pairwise meta- analysis for the other glycemic outcomes was performed . The certainty of the pooled effect estimates was assessed using the GRADE tool . RESULTS Twenty-one trials ( 1,865 participants ) were included . In general , when given alongside gestational weight gain advice , fasting glucose improved in most diets compared to diets that gave gestational weight gain advice only . However , fasting glucose increased in high unsaturated or monounsaturated fatty acids diets . In the absence of gestational weight gain advice , fasting glucose improved in DASH-style diets compared to st and ard of care . Although most were non-significant , similar trends were observed for these same diets for the other glycemic outcomes . Dietary comparisons ranged from moderate to very low in quality of evidence . CONCLUSION /INTERPRETATION Alongside with gestational weight gain advice , most diets , with the exception of a high unsaturated or a high monounsaturated fatty acid diet , demonstrated a fasting glucose improvement compared with gestational weight gain advice only . When gestational weight gain advice was not given , the DASH-style diet appeared optimal on fasting glucose . However , a small number of trials were identified and most dietary comparisons were underpowered to detect differences in glycemic outcomes . Further studies that are high in quality and adequately powered are needed to confirm these findings . REGISTRATION PROSPERO CRD42015026008
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"Balanced glucose metabolism ensures optimal fetal growth with long-term health implication s conferred on both mother and child . We examined whether supplementation of probiotics with dietary counselling affects glucose metabolism in normoglycaemic pregnant women . At the first trimester of pregnancy 256 women were r and omised to receive nutrition counselling to modify dietary intake according to current recommendations or as controls ; the dietary intervention group was further r and omised to receive probiotics ( Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 ; diet/probiotics ) or placebo ( diet/placebo ) in a double-blind manner , whilst the control group received placebo ( control/placebo ) . Blood glucose concentrations were lowest in the diet/probiotics group during pregnancy ( baseline-adjusted means 4.45 , 4.60 and 4.56 mmol/l in diet/probiotics , diet/placebo and control/placebo , respectively ; P = 0.025 ) and over the 12 months ' postpartum period ( baseline-adjusted means 4.87 , 5.01 and 5.02 mmol/l ; P = 0.025 ) . Better glucose tolerance in the diet/probiotics group was confirmed by a reduced risk of elevated glucose concentration compared with the control/placebo group ( OR 0.31 ( 95 % CI 0.12 , 0.78 ) ; P = 0.013 ) as well as by the lowest insulin concentration ( adjusted means 7.55 , 9.32 and 9.27 mU/l ; P = 0.032 ) and homeostasis model assessment ( adjusted means 1.49 , 1.90 and 1.88 ; P = 0.028 ) and the highest quantitative insulin sensitivity check index ( adjusted means 0.37 , 0.35 and 0.35 ; P = 0.028 ) during the last trimester of pregnancy . The effects observed extended over the 12-month postpartum period . The present study demonstrated that improved blood glucose control can be achieved by dietary counselling with probiotics even in a normoglycaemic population and thus may provide potential novel means for the prophylactic and therapeutic management of glucose disorders",
"Objective To determine if a low glycaemic index diet in pregnancy could reduce the incidence of macrosomia in an at risk group . Design R and omised controlled trial . Setting Maternity hospital in Dublin , Irel and . Participants 800 women without diabetes , all in their second pregnancy between January 2007 to January 2011 , having previously delivered an infant weighing greater than 4 kg . Intervention Women were r and omised to receive no dietary intervention or start on a low glycaemic index diet from early pregnancy . Main outcomes The primary outcome measure was difference in birth weight . The secondary outcome measure was difference in gestational weight gain . Results No significant difference was seen between the two groups in absolute birth weight , birthweight centile , or ponderal index . Significantly less gestational weight gain occurred in women in the intervention arm ( 12.2 v 13.7 kg ; mean difference −1.3 , 95 % confidence interval −2.4 to −0.2 ; P=0.01 ) . The rate of glucose intolerance was also lower in the intervention arm : 21 % ( 67/320 ) compared with 28 % ( 100/352 ) of controls had a fasting glucose of 5.1 mmol/L or greater or a 1 hour glucose challenge test result of greater than 7.8 mmol/L ( P=0.02 ) . Conclusion A low glycaemic index diet in pregnancy did not reduce the incidence of large for gestational age infants in a group at risk of fetal macrosomia . It did , however , have a significant positive effect on gestational weight gain and maternal glucose intolerance . Trial registration Current Controlled Trials IS RCT N54392969",
"OBJECTIVE The present study aim ed to compare the effects of a general dietary intervention and an intervention with low glycaemic load ( GL ) on glycaemic control , blood lipid metabolism and pregnancy outcomes in women with gestational diabetes mellitus . DESIGN Participants were r and omly assigned to two groups , receiving either an individualized general dietary intervention ( Control group ) or an intensive low-GL intervention ( Low-GL group ) every two weeks , from 24 - 26 weeks of gestation to delivery . SETTING The Center of Maternal Primary Care in Guangdong General Hospital , China . SUBJECTS Ninety-five women with gestational diabetes mellitus were enrolled from June 2008 to July 2009 . RESULTS After the intervention , both groups significantly decreased their dietary intakes of energy , fat and carbohydrate . The Low-GL group had significantly lower values for GL ( 122 v. 136 ) and glycaemic index ( 50 v. 54 ) but greater dietary fibre intake ( 33 v. 29 g/d ) than did the Control group ( all P greater decreases in fasting plasma glucose ( -0·33 v. -0·02 mmol/l , P glucose ( -2·98 v. -2·51 mmol/l , P , significantly lower increases in total cholesterol ( 0·12 v. 0·23 mmol/l ) and TAG ( 0·41 v. 0·56 mmol/l ) and a significantly lower decrease in HDL cholesterol ( -0·01 v. -0·11 mmol/l ) were also observed in the Low-GL group compared with the Control group ( all P differences in body weight gain , birth weight or other maternal-fetal perinatal outcomes between the two groups . CONCLUSIONS The low-GL targeted dietary intervention outperformed the general dietary intervention in glycaemic control and the improvement of blood lipid levels in women with gestational diabetes mellitus",
"OBJECTIVE Dietary interventions can improve pregnancy outcomes in women with gestational diabetes mellitus ( GDM ) . We compared the effect of a low – glycemic index ( GI ) versus a conventional high-fiber ( HF ) diet on pregnancy outcomes , birth weight z score , and maternal metabolic profile in women at high risk of GDM . RESEARCH DESIGN AND METHODS One hundred thirty-nine women [ mean ( SD ) age 34.7 ( 0.4 ) years and prepregnancy BMI 25.2 ( 0.5 ) kg/m2 ] were r and omly assigned to a low-GI ( LGI ) diet ( n = 72 ; target GI ∼50 ) or a high-fiber , moderate-GI ( HF ) diet ( n = 67 ; target GI ∼60 ) at 14–20 weeks ’ gestation . Diet was assessed by 3-day food records and infant body composition by air-displacement plethysmography , and pregnancy outcomes were assessed from medical records . RESULTS The LGI group achieved a lower GI than the HF group [ mean ( SD ) 50 ( 5 ) vs. 58 ( 5 ) ; P in glycosylated hemoglobin , fructosamine , or lipids at 36 weeks or differences in birth weight [ LGI 3.4 ( 0.4 ) kg vs. HF 3.4 ( 0.5 ) kg ; P = 0.514 ] , birth weight z score [ LGI 0.31 ( 0.90 ) vs. HF 0.24 ( 1.07 ) ; P = 0.697 ] , ponderal index [ LGI 2.71 ( 0.22 ) vs. HF 2.69 ( 0.23 ) kg/m3 ; P = 0.672 ] , birth weight centile [ LGI 46.2 ( 25.4 ) vs. HF 41.8 ( 25.6 ) ; P = 0.330 ] , % fat mass [ LGI 10 ( 4 ) vs. HF 10 ( 4 ) ; P = 0.789 ] , or incidence of GDM . CONCLUSIONS In intensively monitored women at risk for GDM , a low-GI diet and a healthy diet produce similar pregnancy outcomes",
"OBJECTIVE Diet therapy in gestational diabetes mellitus ( GDM ) has focused on carbohydrate restriction but is poorly substantiated . In this pilot r and omized clinical trial , we challenged the conventional low-carbohydrate/higher-fat ( LC/CONV ) diet , hypothesizing that a higher – complex carbohydrate/lower-fat ( CHOICE ) diet would improve maternal insulin resistance ( IR ) , adipose tissue ( AT ) lipolysis , and infant adiposity . RESEARCH DESIGN AND METHODS At 31 weeks , 12 diet-controlled overweight/obese women with GDM were r and omized to an isocaloric LC/CONV ( 40 % carbohydrate/45 % fat/15 % protein ; n = 6 ) or CHOICE ( 60%/25%/15 % ; n = 6 ) diet . All meals were provided . AT was biopsied at 37 weeks . RESULTS After ∼7 weeks , fasting glucose ( P = 0.03 ) and free fatty acids ( P = 0.06 ) decreased on CHOICE , whereas fasting glucose increased on LC/CONV ( P = 0.03 ) . Insulin suppression of AT lipolysis was improved on CHOICE versus LC/CONV ( 56 vs. 31 % , P = 0.005 ) , consistent with improved IR . AT expression of multiple proinflammatory genes was lower on CHOICE ( P 0.01 ) . Infant adiposity trended lower with CHOICE ( 10.1 ± 1.4 vs. 12.6 ± 2 % , respectively ) . CONCLUSIONS A CHOICE diet may improve maternal IR and infant adiposity , challenging recommendations for a LC/CONV diet",
"Background The importance of maternal dietary choline for fetal neural development and later cognitive function has been well-documented in experimental studies . Although choline is an essential dietary nutrient for humans , evidence that low maternal choline in pregnancy impacts neurodevelopment in human infants is lacking . We determined potential associations between maternal plasma free choline and its metabolites betaine and dimethylglycine in pregnancy and infant neurodevelopment at 18 months of age . Methodology This was a prospect i ve study of healthy pregnant women and their full-term , single birth infants . Maternal blood was collected at 16 and 36 weeks of gestation and infant neurodevelopment was assessed at 18 months of age for 154 mother-infant pairs . Maternal plasma choline , betaine , dimethylglycine , methionine , homocysteine , cysteine , total B12 , holotranscobalamin and folate were quantified . Infant neurodevelopment was evaluated using the Bayley Scales of Infant Development – III . Multivariate regression , adjusting for covariates that impact development , was used to determine the associations between maternal plasma choline , betaine and dimethylglycine and infant neurodevelopment . Results The maternal plasma free choline at 16 and 36 weeks gestation was median ( interquartile range ) 6.70 ( 5.78–8.03 ) and 9.40 ( 8.10–11.3 ) µmol/L , respectively . Estimated choline intakes were ( mean ±SD ) 383±98.6 mg/day , and lower than the recommended 450 mg/day . Betaine intakes were 142±70.2 mg/day . Significant positive associations were found between infant cognitive test scores and maternal plasma free choline ( B = 6.054 , SE = 2.283 , p = 0.009 ) and betaine ( B = 7.350 , SE = 1.933 , p = 0.0002 ) at 16 weeks of gestation . Maternal folate , total B12 , or holotranscobalamin were not related to infant development . Conclusion We show that choline status in the first half of pregnancy is associated with cognitive development among healthy term gestation infants . More work is needed on the potential limitation of choline or betaine in the diets of pregnant women",
"OBJECTIVE To our knowledge , no reports are available indicating the effects of the dietary approaches to stop hypertension ( DASH ) eating plan on insulin resistance , inflammation , and oxidative stress among pregnant women with gestational diabetes mellitus ( GDM ) . This study was design ed to investigate the effects of the DASH diet on insulin resistance , serum high-sensitivity C-reactive protein ( hs-CRP ) and biomarkers of oxidative stress among pregnant women with GDM . METHODS This r and omized controlled clinical trial was performed with 32 pregnant women diagnosed with GDM at 24 to 28 wk gestation . Participants were r and omly assigned to consume either the control ( n = 16 ) or DASH diet ( n = 16 ) for 4 wk . The DASH diet was rich in fruits , vegetables , whole grains , and low-fat dairy products and was low in saturated fats , total fats , cholesterol , refined grains , and sweets , with a total of 2400 mg/d of sodium . The control diet contained 40 % to 55 % of its energy as carbohydrates , 10 % to 20 % as proteins , and 25 % to 30 % as total fats . Fasting blood sample s were taken at baseline and after 4 wk of intervention to measure fasting plasma glucose ( FPG ) , serum insulin , and hs-CRP , homeostasis model of assessment -insulin resistance ( HOMA-IR ) , plasma total antioxidant capacity ( TAC ) , and total glutathione levels ( GSH ) . RESULTS Consumption of the DASH diet compared with the control diet result ed in decreased FPG ( -7.62 versus 3.68 mg/dL ; P = 0.02 ) , serum insulin levels ( -2.62 versus 4.32 μIU/mL , P = 0.03 ) , and HOMA-IR score ( -0.8 versus 1.1 ; P = 0.03 ) . Increased concentrations of plasma TAC ( 45.2 versus -159.2 mmol/L ; P of serum hs-CRP levels between the two diets . Within-group comparisons revealed significant reductions in plasma TAC and GSH levels in the control diet , while a significant increase in these biomarkers in the DASH diet . CONCLUSION Consumption of the DASH diet in pregnant women with GDM had beneficial effects on FPG , serum insulin levels , HOMA-IR score , plasma TAC , and total GSH levels . The effects of this dietary pattern on pregnancy outcomes need to be investigated in future studies",
"OBJECTIVE A low – glycemic index diet is effective as a treatment for individuals with diabetes and has been shown to improve pregnancy outcomes when used from the first trimester . A low – glycemic index diet is commonly advised as treatment for women with gestational diabetes mellitus ( GDM ) . However , the efficacy of this advice and associated pregnancy outcomes have not been systematic ally examined . The purpose of this study was to determine whether prescribing a low – glycemic index diet for women with GDM could reduce the number of women requiring insulin without compromise of pregnancy outcomes . RESEARCH DESIGN AND METHODS All women with GDM seen over a 12-month period were considered for inclusion in the study . Women ( n = 63 ) were r and omly assigned to receive either a low – glycemic index diet or a conventional high-fiber ( and higher glycemic index ) diet . RESULTS Of the 31 women r and omly assigned to a low – glycemic index diet , 9 ( 29 % ) required insulin . Of the women r and omly assigned to a higher – glycemic index diet , a significantly higher proportion , 19 of 32 ( 59 % ) , met the criteria to commence insulin treatment ( P = 0.023 ) . However , 9 of these 19 women were able to avoid insulin use by changing to a low – glycemic index diet . Key obstetric and fetal outcomes were not significantly different . CONCLUSIONS Using a low – glycemic index diet for women with GDM effectively halved the number needing to use insulin , with no compromise of obstetric or fetal outcomes",
"Background . Due to the higher prevalence of obesity and diabetes mellitus ( DM ) , more pregnant women complicated with diabetes are in need of clinical care . Purpose . Compare the effect of including only low glycemic index ( GI ) carbohydrates ( CHO ) against all types of CHO on maternal glycemic control and on the maternal and newborn 's nutritional status of women with type 2 DM and gestational diabetes mellitus ( GDM ) . Methods . Women ( n = 107 , ≤29 weeks of gestation ) were r and omly assigned to one of two nutrition intervention groups : moderate energy and CHO restriction ( Group 1 : all types of CHO , Group 2 : low GI foods ) . Results . No baseline differences in clinical data were observed . Capillary glucose concentrations throughout pregnancy were similar between groups . Fewer women in Group 2 exceeded weight gain recommendations . Higher risk of prematurity was observed in women in Group 2 . No differences in glycemic control were observed between women with type 2 DM and those with GDM . Conclusions . Inclusion of low GI CHO as part of a comprehensive nutrition intervention is equally effective in improving glycemic control as compared to all types of CHO . This strategy had a positive effect in preventing excessive maternal weight gain but increased the risk of prematurity",
"Although gestational diabetes mellitus ( GDM ) is associated with an increased risk of maternal and neonatal morbidity , there is no consensus as to the optimal approach of nutritional management in these patients . The present study was design ed to assess the effect of the Dietary Approaches to Stop Hypertension ( DASH ) eating plan on glucose tolerance and lipid profiles of pregnant women with GDM . The present r and omised controlled clinical trial was performed among thirty-four women diagnosed with GDM at 24 - 28 weeks of gestation . Subjects were r and omly assigned to consume either the control diet ( n 17 ) or the DASH eating pattern ( n 17 ) for 4 weeks . The control diet was design ed to contain 45 - 55 % carbohydrates , 15 - 20 % protein and 25 - 30 % total fat . The macronutrient composition of the DASH diet was similar to the control diet ; however , the DASH diet was rich in fruits , vegetables , whole grains and low-fat dairy products , and contained lower amounts of saturated fats , cholesterol and refined grains with a total of 2400 mg Na/d . Fasting blood sample s were taken at baseline and after 4 weeks of intervention to measure fasting plasma glucose , glycated Hb ( HbA1c ) and lipid profiles . Participants underwent a 3 h oral glucose tolerance tests and blood sample s were collected at 60 , 120 and 180 min to measure plasma glucose levels . Adherence to the DASH eating pattern , compared with the control diet , result ed in improved glucose tolerance such that plasma glucose levels reduced at 60 ( 21·86 v. 20·45 mmol/l , Pgroup = 0·02 ) , 120 ( 22·3 v. 0·2 mmol/l , Pgroup = 0·001 ) and 180 min ( 21·7 v. 0·22 mmol/l , Pgroup = 0·002 ) after the glucose load . Decreased HbA1c levels ( 20·2 v. 0·05 % , Pgroup = 0·001 ) was also seen in the DASH group compared with the control group . Mean changes for serum total ( 20·42 v. 0·31 mmol/l , Pgroup = 0·01 ) and LDL-cholesterol ( 20·47 v. 0·22 mmol/l , Pgroup = 0·005 ) , TAG ( 20·17 v. 0·34 mmol/l , Pgroup = 0·01 ) and total : HDL-cholesterol ratio ( 20·6 ( SD 0·9 ) v. 0·3 ( SD 0·8 ) , Pgroup = 0·008 ) were significantly different between the two diets . Additionally , consumption of the DASH diet favourably influenced systolic blood pressure ( 22·6 v. 1·7 mmHg , Pgroup = 0·001 ) . Mean changes of fasting plasma glucose ( 20·29 v. 0·15 mmol/l , Pgroup = 0·09 ) were nonsignificant comparing the DASH diet with the control diet . In conclusion , consumption of the DASH eating pattern for 4 weeks among pregnant women with GDM result ed in beneficial effects on glucose tolerance and lipid profiles compared with the control diet",
"AIM The objectives of this pilot study were to determine the feasibility and effect on glycaemic control of a low-glycaemic-index ( GI ) diet in women with gestational diabetes or impaired glucose tolerance of pregnancy . METHODS participants , recruited from the Diabetes-in-Pregnancy Clinic of an inner-city teaching hospital serving a predominantly non-Caucasian population , were r and omized to a low-GI ( n=23 ) or control ( n=24 ) diet and followed from 28 weeks gestation until delivery . Self-monitored-blood-glucose ( SMBG ) , maternal and infant weight were collected from medical charts . Dietary intakes were assessed using diet records and question naires . RESULTS diet GI on control ( 58 , 95 % CI : 56,60 ) was significantly higher than on low-GI ( 49 , 95 % CI : 47,51 ; p=0.001 ) . Glycaemic control improved on both diets , but more postpr and ial glucose values were within target on low-GI ( 58.4 % of n=1891 ) than control ( 48.7 % of n=1834 ; p SMBG post-breakfast was directly related to pre-pregnancy BMI in the control , but not the low-GI group ( BMI * diet interaction ; p=0.021 ) . Participants accepted the study foods and were willing to consume them post-intervention . CONCLUSIONS a low-GI diet was feasible and acceptable in this sample and facilitated control of postpr and ial glucose . A larger study is needed to determine the effect of a low-GI diet on maternal and infant outcomes",
"Summary : A r and omised controlled trial was design ed to determine the effect of moderate 30 % maternal dietary energy restriction on the requirement for maternal insulin therapy and the incidence of macrosomia in gestational diabetes . Although the control group restricted their intake to a level similar to that of the intervention group ( 6845 kiloJoules ( kJ ) versus 6579 kJ ) , the result ing cohort could not identify any adverse effect of energy restriction in pregnancy . Energy restriction did not alter the frequency of insulin therapy ( 17.5 % in the intervention group and 16.9 % in the control group ) . Mean birth weight ( 3461 g in the intervention group and 3267 g in the control group ) was not affected . There was a trend in the intervention group towards later gestational age at commencement of insulin therapy ( 33 weeks versus 31 weeks ) and lower maximum daily insulin dose ( 23 units versus 60 units ) which did not reach statistical significance . Energy restriction did not cause an increase in ketonemia",
"OBJECTIVE This study aims to determine the impact of increasing polyunsaturated fatty acid intake on blood glucose , lipid metabolism , and pregnancy outcomes of pregnant women with gestational diabetes mellitus . METHODS Under constant total energy and protein intake , 84 pregnant women with gestational diabetes mellitus were r and omly divided into the experimental and control groups , which were given oil-rich and conventional low-oil meals , respectively . RESULTS After the dietary intervention , the intake and energy supply of fat and the three fatty acids were significantly higher in the experimental group than the control group ( p intake and energy supply of polyunsaturated fatty acids increased significantly post-intervention in the experimental group but did not change in the control group . In both the intervention and the control group , fasting blood glucose , 2 h postpr and ial plasma glucose , and the insulin resistance index decreased significantly post-intervention ( p lipid changes were consistent between groups . Pregnancy outcomes did not differ significantly between the two groups ( p>0.05 ) . CONCLUSIONS An appropriate increase in polyunsaturated fatty acid intake benefits pregnant women with gestational diabetes mellitus as well as fetuses , as long as the diet therapy follows basic recommendations and total energy intake is strictly controlled",
"BACKGROUND Women with gestational diabetes mellitus are rarely treated with a sulfonylurea drug , because of concern about teratogenicity and neonatal hypoglycemia . There is little information about the efficacy of these drugs in this group of women . METHODS We studied 404 women with singleton pregnancies and gestational diabetes that required treatment . The women were r and omly assigned between 11 and 33 weeks of gestation to receive glyburide or insulin according to an intensified treatment protocol . The primary end point was achievement of the desired level of glycemic control . Secondary end points included maternal and neonatal complications . RESULTS The mean ( + /-SD ) pretreatment blood glucose concentration as measured at home for one week was 114+/-19 mg per deciliter ( 6.4+/-1.1 mmol per liter ) in the glyburide group and 116+/-22 mg per deciliter ( 6.5+/-1.2 mmol per liter ) in the insulin group ( P=0.33 ) . The mean concentrations during treatment were 105+/-16 mg per deciliter ( 5.9+/-0.9 mmol per liter ) in the glyburide group and 105+/-18 mg per deciliter ( 5.9+/-1.0 mmol per liter ) in the insulin group ( P=0.99 ) . Eight women in the glyburide group ( 4 percent ) required insulin therapy . There were no significant differences between the glyburide and insulin groups in the percentage of infants who were large for gestational age ( 12 percent and 13 percent , respectively ) ; who had macrosomia , defined as a birth weight of 4000 g or more ( 7 percent and 4 percent ) ; who had lung complications ( 8 percent and 6 percent ) ; who had hypoglycemia ( 9 percent and 6 percent ) ; who were admitted to a neonatal intensive care unit ( 6 percent and 7 percent ) ; or who had fetal anomalies ( 2 percent and 2 percent ) . The cord-serum insulin concentrations were similar in the two groups , and glyburide was not detected in the cord serum of any infant in the glyburide group . CONCLUSIONS In women with gestational diabetes , glyburide is a clinical ly effective alternative to insulin therapy",
"INTRODUCTION Nutrition therapy is an integral part of the management of gestational diabetes mellitus ( GDM ) . Most women with GDM are treated by nutritional management alone . The goal of our study was to compare low and high carbohydrate diets in their effectiveness , safety and tolerability in women with GDM . MATERIAL AND METHODS The study group consisted of 30 Caucasian women newly diagnosed with GDM , with a mean age of 28.7 + /- 3.7 years and pregnancy duration of 29.2 + /- 5.4 weeks . The patients were r and omised into two groups : those on a low and those on a high carbohydrate diet ( 45 % vs. 65 % respectively of energy supply coming from carbohydrates ) . The presence of urine ketones was controlled every day . After two weeks daily glucose profiles and compliance with the recommended diets were analysed . RESULTS Glucose concentration before implementation of the diet regimen did not differ between groups . No changes in fasting blood glucose were noticed in the group that had followed a low carbohydrate diet , although a significant decrease in glucose concentration was observed after breakfast ( 102 + /- 16 vs. 94 + /- 11 mg/dl ) , lunch ( 105 + /- 12 vs. 99 + /- 9 mg/dl ) and dinner ( 112 + /- 16 vs. 103 + /- 13 mg/dl ) ( p high carbohydrate diet group fasting and after-breakfast glucose concentration did not change . A significant decrease in glycaemia was noticed after lunch ( 106 + /- 15 vs. 96 + /- 7 mg/dl ) and dinner ( 107 + /- 12 vs. 97 + /- 7 mg/dl ) ( p Ketonuria was not observed in either group . Obstetrical outcomes did not differ between groups . CONCLUSIONS Both high and low carbohydrate diets are effective and safe . A diet with carbohydrate limitation should be recommended to women who experience the highest glycaemia levels after breakfast",
"Five quantitative measures of diabetic control [ HbA1c determinations , mean 24-h plasma glucose values , mean amplitude of glycemic excursions ( MAGE ) , mean 24-h urinary loss of glucose , and daily exogenous insulin requirement ] were compared in 20 pregnant women who were r and omly assigned to either a high-carbohydrate , high-fiber diet ( HCF ) that was low in fat or to a control diet commonly prescribed for pregnancy . Eleven women followed the HCF diet and nine subjects , the control diet , from baseline entry into the study until delivery . Dietary compliance was excellent , with 78 % of the women in each group rated good or acceptable . HbA1c values were similar in both groups at baseline ( HCF : 11.0 ± 0.5 % versus control : 10.2 ± 0.6 % ) , with no different predelivery values ( 8.6 ± 0.4 % ) . Mean 24-h plasma glucose levels improved in patients on both diets , with lower values noted in the HCF group at predelivery . MAGE values and st and ard deviations did not differ significantly in the two groups . Glycosuria decreased markedly in both dietary groups , but differences between groups were not significant . Improved control of diabetes on the HCF diet was achieved with significantly lower increments in insulin dose during gestation ( HCF baseline : 32 ± 8 U/24 h to 66 ± 10 U/24 h versus control baseline : 27 ± 9 U/24 h to 108 ± 12 U/24 h , P 0.03 ) . Outcome of pregnancy did not differ in the two groups of patients , but women on the HCF diet gained less weight than those on the control diet ( 26 ± 3 lb versus 35 ± 5 lb , P was similar in the two groups ( HCF : 37.2 ± 0.7 wk versus control : 36.5 ± 0.7 wk ) . Mean birth weight in infants of HCF mothers ± was 3809 ± 248 g versus 3313 ± 278 g in infants of control mothers ( P on the HCF diet achieved better control of diabetes with significantly lower increments in exogenous insulin",
"Background : A low-glycemic index diet is effective in blood glucose control of diabetic subjects , reduces insulin requirement in women with gestation diabetes mellitus ( GDM ) and improves pregnancy outcomes when used from beginning of the second trimester . However there are limited reports to examine the effect of low glycemic load ( LGL ) diet and fiber on blood glucose control and insulin requirement of women with GDM . Therefore , the aim of this study was to examine the effect of low glycemic load diet with and without fiber on reducing the number of women with GDM requiring insulin . Material s and Methods : All GDM women ( n = 31 ) were r and omly allocated to consume either a LGL diet with Fiber or LGL diet . Results : We found that 7 ( 38.9 % ) of 18 women with GDM in Fiber group and 10 ( 76.9 % ) in “ Without Fiber ” group required insulin treatment . Conclusion : The LGL diet with added fiber for women with GDM dramatically reduced the number needing for insulin treatment"
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41174b6e-06ff-11f0-808a-c43d1ab1c353
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The aim of this systematic review is to evaluate whether the use of probiotics has any effect on the components of metabolic syndrome ( MetS ) before patients develop type 2 diabetes . A qualitative systematic review , following the Cochrane methodology , and a comprehensive literature search of r and omized controlled trials ( RCTs ) were conducted in PubMed and Scopus from inception until 4 July 2019 . According to our inclusion criteria , nine clinical studies were finally analyzed , corresponding to six RCTs . Probiotics intake in patients with MetS result ed in improvements in body mass index , blood pressure , glucose metabolism , and lipid profile in some studies . Regarding inflammatory biomarkers , probiotics also positively affected the soluble vascular cell adhesion molecule 1 ( sVCAM-1 ) , interleukine-6 ( IL-6 ) , tumor necrosis factor α ( TNF-α ) , vascular endothelial growth factor ( VEGF ) , and thrombomodulin . Despite the diversity of the published studies , the intake of probiotics for patients with MetS may offer a discrete improvement in some of the clinical characteristics of the MetS and a decrease in inflammatory biomarkers . Nevertheless , these beneficial effects seem to be marginal compared to drug therapy and a healthy lifestyle and clinical ly non-relevant
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"Background Gut lactobacilli can affect the metabolic functions of healthy humans . We tested whether a 1500 kcal/d diet supplemented with cheese containing the probiotic Lactobacillus plantarum TENSIA ( Deutsche Sammlung für Mikroorganismen , DSM 21380 ) could reduce some symptoms of metabolic syndrome in Russian adults with obesity and hypertension . Methods In this 3-week , r and omized , double-blind , placebo-controlled , parallel pilot study , 25 subjects ingested probiotic cheese and 15 ingested control cheese . Fifty grams of each cheese provided 175 kcal of energy . Blood pressure ( BP ) , anthropometric characteristics , markers of liver and kidney function , metabolic indices ( plasma glucose , lipids , and cholesterol ) , and urine polyamines were measured . Counts of fecal lactobacilli and L. plantarum TENSIA were evaluated using molecular methods . The data were analyzed by t-test for independent sample s and Spearman ’s partial correlation analysis . Results The probiotic L. plantarum TENSIA was present in variable amounts ( 529.6 ± 232.5 gene copies ) in 16/25 ( 64 % ) study subjects . Body mass index ( BMI ) was significantly reduced ( p = 0.031 ) in the probiotic cheese group versus the control cheese group . The changes in BMI were closely associated with the water content of the body ( r = 0.570 , p = 0.0007 ) when adjusted for sex and age . Higher values of intestinal lactobacilli after probiotic cheese consumption were associated with higher BMI ( r = 0.383 , p = 0.0305 ) and urinary putrescine content ( r = 0.475 , p = 0.006 ) . In patients simultaneously treated with BP-lowering drugs , similar reductions of BP were observed in both groups . A positive association was detected between TENSIA colonization and the extent of change of morning diastolic BP ( r = 0.617 , p = 0.0248 ) and a trend toward lower values of morning systolic BP ( r = −0.527 , p = 0.0640 ) at the end of the study after adjusting for BMI , age , and sex . Conclusion In a pilot study of obese hypertensive patients , a hypocaloric diet supplemented with a probiotic cheese helps to reduce BMI and arterial BP values , recognized symptoms of metabolic syndrome . Trial registration Current Controlled Trials IS RCT",
"Obesity in the postmenopausal period is associated with an increased risk of cardiovascular diseases in women . One of the key drivers of cardiovascular risk is endothelial dysfunction ; thus , this is also a crucial point for studies on new therapeutic methods of cardioprotective properties . The aim of the current study was to evaluate the effect of two doses of multispecies probiotic Ecologic ® Barrier supplement on functional ( primary endpoint ) and biochemical parameters ( secondary endpoint ) of endothelial dysfunction in obese postmenopausal women in a 12-week r and omized , placebo-controlled clinical trial . A total of 81 obese Caucasian women participated in the trial . The subjects were r and omly assigned to three groups that received a placebo , a low dose ( LD ) ( 2.5 × 109 colony forming units ( CFU ) per day ) , or a high dose ( HD ) ( 1 × 1010 CFU per day ) of lyophilisate powder containing live multispecies probiotic bacteria . The probiotic supplement was administered each day for 12 weeks in two equal portions . A high dose probiotic supplementation for 12 weeks decreased systolic blood pressure , vascular endothelial growth factor , pulse wave analysis systolic pressure , pulse wave analysis pulse pressure , pulse wave analysis augmentation index , pulse wave velocity , interleukin-6 , tumor necrosis factor alpha , and thrombomodulin . Low doses of probiotic supplementation decreased the systolic blood pressure and interleukin-6 levels . The mean changes in the estimated parameters , compared among the three groups , revealed significant differences in the vascular endothelial growth factor , the pulse wave analysis systolic pressure , the pulse wave analysis augmentation index , the pulse wave velocity , the tumor necrosis factor alpha , and thrombomodulin . The post hoc tests showed significant differences for all parameters between HD and the placebo group , and HD and LD ( besides pulse wave analysis augmentation index ) . We show for the first time that supplementation with multispecies probiotic Ecologic ® Barrier favorably modifies both functional and biochemical markers of vascular dysfunction in obese postmenopausal women"
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41174baa-06ff-11f0-808a-c43d1ab1c353
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Background / Objectives : Numerous r and omised controlled trials ( RCTs ) published in first tier medical journals have evaluated the health effects of diets high in protein . We conducted a rigorous systematic review of RCTs comparing higher- and lower-protein diets . Methods : We search ed several electronic data bases up to July 2011 for studies focusing on patient-important outcomes ( for example , cardiovascular disease ) and secondary outcomes such as risk factors for chronic disease ( for example , adiposity ) . Results : We identified 111 articles reporting on 74 trials . Pooled effect sizes using st and ardised mean differences ( SMDs ) were small to moderate and favoured higher-protein diets for weight loss ( SMD −0.36 , 95 % confidence interval ( CI ) −0.56 to −0.17 ) , body mass index ( −0.37 , CI −0.56 to 0.19 ) , waist circumference ( −0.43 , CI −0.69 to −0.16 ) , blood pressure ( systolic : −0.21 , CI −0.32 to −0.09 and diastolic : −0.18 , CI −0.29 to −0.06 ) , high-density lipoproteins ( HDL 0.25 , CI 0.07 to 0.44 ) , fasting insulin ( −0.20 , CI −0.39 to −0.01 ) and triglycerides ( −0.51 , CI −0.78 to −0.24 ) . Sensitivity analysis of studies with lower risk of bias abolished the effect on HDL and fasting insulin , and reduced the effect on triglycerides . We observed nonsignificant effects on total cholesterol , low-density lipoproteins , C-reactive protein , HbA1c , fasting blood glucose , and surrogates for bone and kidney health . Adverse gastrointestinal events were more common with high-protein diets . Multivariable meta-regression analysis showed no significant dose response with higher protein intake . Conclusions : Higher-protein diets probably improve adiposity , blood pressure and triglyceride levels , but these effects are small and need to be weighed against the potential for harms
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"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",
"CONTEXT Reduced intake of saturated fat is widely recommended for prevention of cardiovascular disease . The type of macronutrient that should replace saturated fat remains uncertain . OBJECTIVE To compare the effects of 3 healthful diets , each with reduced saturated fat intake , on blood pressure and serum lipids . DESIGN , SETTING , AND PARTICIPANTS R and omized , 3-period , crossover feeding study ( April 2003 to June 2005 ) conducted in Baltimore , Md , and Boston , Mass. Participants were 164 adults with prehypertension or stage 1 hypertension . Each feeding period lasted 6 weeks and body weight was kept constant . INTERVENTIONS A diet rich in carbohydrates ; a diet rich in protein , about half from plant sources ; and a diet rich in unsaturated fat , predominantly monounsaturated fat . MAIN OUTCOME MEASURES Systolic blood pressure and low-density lipoprotein cholesterol . RESULTS Blood pressure , low-density lipoprotein cholesterol , and estimated coronary heart disease risk were lower on each diet compared with baseline . Compared with the carbohydrate diet , the protein diet further decreased mean systolic blood pressure by 1.4 mm Hg ( P = .002 ) and by 3.5 mm Hg ( P = .006 ) among those with hypertension and decreased low-density lipoprotein cholesterol by 3.3 mg/dL ( 0.09 mmol/L ; P = .01 ) , high-density lipoprotein cholesterol by 1.3 mg/dL ( 0.03 mmol/L ; P = .02 ) , and triglycerides by 15.7 mg/dL ( 0.18 mmol/L ; P diet , the unsaturated fat diet decreased systolic blood pressure by 1.3 mm Hg ( P = .005 ) and by 2.9 mm Hg among those with hypertension ( P = .02 ) , had no significant effect on low-density lipoprotein cholesterol , increased high-density lipoprotein cholesterol by 1.1 mg/dL ( 0.03 mmol/L ; P = .03 ) , and lowered triglycerides by 9.6 mg/dL ( 0.11 mmol/L ; P = .02 ) . Compared with the carbohydrate diet , estimated 10-year coronary heart disease risk was lower and similar on the protein and unsaturated fat diets . CONCLUSION In the setting of a healthful diet , partial substitution of carbohydrate with either protein or monounsaturated fat can further lower blood pressure , improve lipid levels , and reduce estimated cardiovascular risk . Clinical Trials Registration Clinical Trials.gov Identifier : NCT00051350",
"Weight loss causes bone mineral loss . Higher protein diets continue to be criticized for further potential harmful bone effects , including elevated urinary calcium , but may promote bone health if protein sources include dairy . Overweight middle-aged subjects ( n = 130 , 59 males ) were r and omized to a diet providing 1.4 g.kg(-1).d(-1 ) protein and 3 daily servings of dairy ( PRO ) or 0.8 g.kg(-1).d(-1 ) protein and 2 daily servings of dairy ( CARB ) for 4 mo of weight loss plus 8 mo of weight maintenance . Diets prescribed 6276 kJ/d for females and 7113 kJ/d for males . Bone mineral content and density ( BMD ) for whole body ( WB ) , lumbar spine ( LS ) and total hip ( TH ) were measured using dual X-ray absorptiometry , and dietary intake using 3-d weighed food records . Urinary calcium was measured using 24-h collection at 0 and 8 mo for a sub sample ( n = 42 ) . Participants lost body weight ( mean , 95 % CI ) of 8.2 % ( 7.5 - 8.9 % ) at 4 mo , 10.6 % ( 9.5 - 11.8 % ) at 8 mo , and 10.5 % ( 8.9 - 12.0 % ) at 12 mo without differences between groups at any time ( P = 0.64 ) . At 12 mo , PRO BMD was higher by 1.6 % ( 0.3 - 3.0 % ) at WB , 2.1 % ( 0.6 - 3.7 % ) at LS , and 1.4 % ( 0.2 - 2.5 % ) at TH compared with CARB . PRO calcium intake was higher ( PRO : 1140 + /- 58 mg/d , CARB : 766 + /- 46 ; P urinary calcium ( PRO : 163 + /- 15 mg/d , CARB : 100 + /- 9.2 ; P reduced-energy diet supplying 1.4 g.kg(-1).d(-1 ) protein and 3 dairy servings increased urinary calcium excretion but provided improved calcium intake and attenuated bone loss over 4 mo of weight loss and 8 additional mo of weight maintenance",
"BACKGROUND The possible advantage for weight loss of a diet that emphasizes protein , fat , or carbohydrates has not been established , and there are few studies that extend beyond 1 year . METHODS We r and omly assigned 811 overweight adults to one of four diets ; the targeted percentages of energy derived from fat , protein , and carbohydrates in the four diets were 20 , 15 , and 65 % ; 20 , 25 , and 55 % ; 40 , 15 , and 45 % ; and 40 , 25 , and 35 % . The diets consisted of similar foods and met guidelines for cardiovascular health . The participants were offered group and individual instructional sessions for 2 years . The primary outcome was the change in body weight after 2 years in two-by-two factorial comparisons of low fat versus high fat and average protein versus high protein and in the comparison of highest and lowest carbohydrate content . RESULTS At 6 months , participants assigned to each diet had lost an average of 6 kg , which represented 7 % of their initial weight ; they began to regain weight after 12 months . By 2 years , weight loss remained similar in those who were assigned to a diet with 15 % protein and those assigned to a diet with 25 % protein ( 3.0 and 3.6 kg , respectively ) ; in those assigned to a diet with 20 % fat and those assigned to a diet with 40 % fat ( 3.3 kg for both groups ) ; and in those assigned to a diet with 65 % carbohydrates and those assigned to a diet with 35 % carbohydrates ( 2.9 and 3.4 kg , respectively ) ( P>0.20 for all comparisons ) . Among the 80 % of participants who completed the trial , the average weight loss was 4 kg ; 14 to 15 % of the participants had a reduction of at least 10 % of their initial body weight . Satiety , hunger , satisfaction with the diet , and attendance at group sessions were similar for all diets ; attendance was strongly associated with weight loss ( 0.2 kg per session attended ) . The diets improved lipid-related risk factors and fasting insulin levels . CONCLUSIONS Reduced-calorie diets result in clinical ly meaningful weight loss regardless of which macronutrients they emphasize . ( Clinical Trials.gov number , NCT00072995 .",
"Context Low-carbohydrate weight reduction diets are popular despite a dearth of data on long-term efficacy and adverse effects . Contribution Community-dwelling hyperlipidemic persons were r and omly assigned to either a low-carbohydrate , ketogenic diet or a low-fat , low-cholesterol , reduced-calorie diet for 24 weeks . Compared to the low-fat group , patients in the low-carbohydrate group lost more weight , had a greater decrease in triglyceride levels , and had higher high-density lipoprotein cholesterol levels . Levels of low-density lipoprotein cholesterol remained stable in both groups . Side effects were more common in the low-cholesterol group but were generally mild . Caution s While the study suggests the efficacy and relative safety of the low-cholesterol diet , the high dropout rate , self-directed adherence to the diet , and relatively short observation period challenge the generalizability of the findings . The Editors As the prevalence of obesity has increased over the past 20 years ( 1 ) , the difficulties faced by overweight patients and their health care practitioners have become apparent . Fewer than 25 % of Americans who attempt to lose weight actually reduce caloric intake and increase exercise as currently recommended ( 2 ) . Persons who successfully lose weight have difficulty maintaining their weight loss ( 3 ) . Therefore , it is not surprising that consumers spend $ 33 billion yearly on weight loss products and services in search of effective therapies ( 2 ) . Because many weight loss interventions are unproven and untested , practitioners often lack information with which to recommend a certain therapy or to monitor a patient once a therapy is chosen . One approach to weight loss that has gained recognition in the face of modest supportive scientific evidence is the low-carbohydrate diet . A popular version of this diet recommends extreme restriction of carbohydrate intake to less than 20 g/d initially ( 4 ) . This level of carbohydrate restriction can induce serum and urinary ketones and weight loss ( 5 , 6 ) . However , until recently , available data on low-carbohydrate diets came from small studies of short duration , most of which were uncontrolled ( 5 , 7 - 10 ) . We examined body weight , body composition , serum lipid levels , and adverse effects over 24 weeks in hyperlipidemic persons who were r and omly assigned to follow a low-carbohydrate , ketogenic diet or a low-fat , low-cholesterol , reduced-calorie diet commonly used to induce weight loss and decrease serum lipid levels . Methods Participants Generally healthy persons were recruited from the community . Inclusion criteria were age 18 to 65 years , body mass index of 30 to 60 kg/m2 , desire to lose weight , elevated lipid levels ( total cholesterol level > 5.17 mmol/L [ > 200 mg/dL ] , low-density lipoprotein [ LDL ] cholesterol level > 3.36 mmol/L [ > 130 mg/dL ] , or triglyceride level > 2.26 mmol/L [ 200 mg/dL ] ) , and no serious medical condition . Exclusion criteria were use of any prescription medication in the previous 2 months ( except for oral contraceptives , estrogen therapy , and stable thyroid medication ) , pregnancy or breastfeeding , use of any weight loss diet or diet pills in the previous 6 months , and baseline ketonuria . All participants provided written informed consent , and the institutional review board of Duke University Health System approved the study . Participants received no monetary incentive . Interventions By using a computer-generated simple r and omization list , participants were allocated to receive the low-carbohydrate diet or low-fat diet . The intervention for both groups included group meetings , diet instruction , and an exercise recommendation . Group meetings took place at an outpatient research clinic twice monthly for 3 months , then monthly for 3 months . These meetings typically lasted 1 hour and consisted of diet instruction , supportive counseling , question naires , and biomedical measurements . During the study , participants selected their own menus and prepared or bought their own meals according to the guidelines presented to them . Participants were encouraged to exercise for 30 minutes at least 3 times weekly , but no formal exercise program or incentives were provided . Low-Carbohydrate Diet Using a popular diet book published by a lay press and additional h and outs , trained research staff instructed participants to restrict intake of carbohydrates to less than 20 g/d ( 4 ) . Participants were permitted unlimited amounts of animal foods ( meat , fowl , fish , and shellfish ) , unlimited eggs , 4 oz of hard cheese , 2 cups of salad vegetables ( such as lettuce , spinach , or celery ) , and 1 cup of low-carbohydrate vegetables ( such as broccoli , cauliflower , or squash ) daily . Participants were encouraged to drink 6 to 8 glasses of water daily . When participants were halfway to their goal body weight ( determined at the week 10 visit with assistance from research personnel ) , they were advised to add approximately 5 g of carbohydrates to their daily intake each week until they reached a level at which body weight was maintained . To simulate the practice of the study sponsor , the low-carbohydrate diet group also received daily nutritional supplements ( multivitamin , essential oils , diet formulation , and chromium picolinate ; for a list of the composition of these supplements , see the Appendix ) ( 6 ) . Low-Fat Diet Using a commonly available booklet and additional h and outs , a registered dietitian instructed participants in a diet consisting of less than 30 % of daily energy intake from fat , less than 10 % of daily energy intake from saturated fat , and less than 300 mg of cholesterol daily ( 11 , 12 ) . The recommended energy intake was 2.1 to 4.2 MJ ( 500 to 1000 kcal ) less than the participant 's calculated energy intake for weight maintenance ( body weight in pounds 10 ) ( 13 ) . Primary Outcome Measure Body weight and body mass index were the primary outcome measures . At each visit , participants were weighed on the same calibrated scale while wearing lightweight clothing and no shoes . Body mass index was calculated as body weight in kilograms divided by height in meters squared . Secondary Outcome Measures Adherence Adherence to the diet was measured by self-report , food records , and , for the low-carbohydrate diet group , urinary ketone assessment . Diet Composition All participants completed a 24-hour recall of food intake at baseline and take-home food records ( 5 consecutive days , including a weekend ) that were collected at each meeting during the study . Participants were instructed on how to document food intake and were given h and outs with examples of how to complete the records . A sample of participants ( 13 in the low-carbohydrate diet group and 7 in the low-fat diet group ) who completed the study was selected for food record analysis by the research staff on the basis of adequacy of detail in their records . A registered dietitian analyzed the food records by using a nutrition software program ( Nutritionist Five , version 1.6 [ First Data Bank , Inc. , San Bruno , California ] ) . Ketonuria Restriction of dietary intake of carbohydrates to less than 40 g/d typically results in ketonuria that is detectable by dipstick analysis , which can be used to monitor adherence to the low-carbohydrate diet ( 14 , 15 ) . At each return visit , participants provided a fresh urine specimen for analysis . The following semi-quantitative scale was used to categorize ketone content : none , trace ( up to 0.9 mmol/L [ 5 mg/dL ] ) , small ( 0.9 to 6.9 mmol/L [ 5 to 40 mg/dL ] ) , moderate ( 6.9 to 13.8 mmol/L [ 40 to 80 mg/dL ] ) , large80 ( 13.8 to 27.5 mmol/L [ 80 to 160 mg/dL ] ) , and large160 ( > 27.5 mmol/L [ > 160 mg/dL ] ) . Body Composition Body composition was estimated by using bioelectric impedance ( model TBF-300A [ Tanita Corp. , Arlington Heights , Illinois ] ) at approximately the same time of day ( afternoon or evening ) at each return visit . In a subset of 33 participants , the percentage of body fat as measured by bioelectric impedance had excellent correlation with the percentage as measured by dual-energy x-ray absorptiometry ( r = 0.93 [ 95 % CI , 0.87 to 0.97 ] ) . Vital Signs Blood pressure and pulse rate were measured in the nondominant arm by using an automated digital cuff ( model HEM-725C [ Omron Corp. , Vernon Hills , Illinois ] ) after the participant had been sitting for 3 minutes . Two measurements were taken at each visit and averaged for the analysis . Serum Lipids and Lipoproteins Serum specimens for lipid measurement were obtained in the morning after at least 8 hours of fasting at the screening visit and at 8 , 16 , and 24 weeks . Other Metabolic Effects Serum tests for sodium , potassium , chloride , urea nitrogen , creatinine , calcium , phosphorus , total protein , albumin , uric acid , total bilirubin , alanine aminotransferase , aspartate aminotransferase , alkaline phosphatase , thyroid-stimulating hormone , iron , hemoglobin , leukocyte count , and platelet count were obtained at the screening visit and at 8 , 16 , and 24 weeks . The glomerular filtration rate was estimated by using an equation that included age ; sex ; race ; and serum levels of albumin , creatinine , and urea nitrogen ( Modification of Diet in Renal Disease Study equation ) ( 16 ) . Adverse Effects At all return visits , participants completed an open-ended question naire on side effects . At the 20- and 24-week visits , participants completed a checklist of the side effects that were most often mentioned during the study . Statistical Analysis Analyses were performed by using S-PLUS software , version 6.1 ( Insightful Corp. , Seattle , Washington ) , or SAS software , version 8.02 ( SAS Institute , Inc. , Cary , North Carolina ) . For categorical outcomes , groups were compared by using the chi-square test or Fisher exact test , as appropriate . For all primary and secondary continuous outcomes , linear mixed-effects models ( PROC MIXED procedure in SAS software ) that included fixed and r and om effects were used to determine expected mean values at each time point and to test hypotheses of group differences . In most body weight and",
"Objective : To determine the effect of high-protein diets , which have recently been promoted for their health benefits , on urinary calcium losses and bone turnover in older subjects . Design : R and omized controlled cross-over study . Setting : Teaching hospital and university . Subjects : Twenty hyperlipidemic men and postmenopausal women ( age 56±2 y ) completed the study . Interventions : One-month test and control phases during which subjects consumed equi-energy metabolic diets high in calcium ( 1578 and 1593 mg/day , respectively ) . On the test diet 11 % of total dietary energy from starch in the control bread was replaced by protein ( wheat gluten ) , result ing in 27 % of energy from protein on the test diet vs 16 % on the control diet . Main outcome measure : Urinary calcium excretion . Results : Compared with the control diet , at week 4 , the test diet increased mean ( ±s.e.m . ) 24 h urinary output of calcium ( 139±15 vs 227±21 mg , P=0.004 ) . The treatment difference in urinary calcium loss correlated with the serum anion gap as a marker of metabolic acid production ( r=0.57 , P=0.011 ) . Serum calcium levels were marginally lower 2.41±0.02 vs 2.38±0.02 mmol/l ( P=0.075 ) , but there was no significant treatment difference in calcium balance , possibly related to the high background calcium intake on both diets . Conclusions : In the presence of high dietary calcium intakes the vegetable protein gluten does not appear to have a negative effect on calcium balance despite increased urinary calcium loss . Sponsorship : The University-Industry Research Partnership Program of the Natural Sciences and Engineering Research Council of Canada , Loblaw Br and s Limited , Toronto , ON , and Kraft Canada Inc. Don Mills , ON . DJAJ is funded as a Canada Research Chair in Metabolism and Nutrition at the University of Toronto by the Federal Government of Canada , Ottawa",
"Objective : To assess the effects of a diet rich in protein of animal origin in comparison to one with a protein intake of about 15 % of the total daily calories on body composition and arterial function . Design : R and omized prospect i ve study with parallel groups . Body weight ( BW ) , blood pressure ( BP ) , main parameters of carbohydrate and lipid metabolism , body mass composition by bioelectrical impedance analysis , forearm blood flow at rest and in the postischaemic phase by strain gauge plethysmography and flow-mediated dilation of the brachial artery by echography were measured at baseline and after 6 months of the dietary intervention . Subjects : In total , 15 clinical ly healthy male volunteers , regularly performing a mixed training three times weekly for 90 min . Intervention : The participants were r and omly prescribed a diet with high ( 1.9 g/kg BW ) or normal ( 1.3 g/kg BW ) protein content . Statistical analysis : Differences between means were evaluated by the t-tests for paired or unpaired data and by one way analysis of variance . The strength of correlation between variables was investigated by bivariate Pearson correlation . Results : Serum cholesterol significantly decreased with both diets in comparison to baseline values , whereas BW was slightly but significantly reduced only by the high-protein ( HP ) diet . No change was detected in BP and the other metabolic parameters . Body mass composition was not significantly modified by either diet . On the other h and , postischaemic flow-mediated dilation of the brachial artery was enhanced by the sole normal protein ( NP ) diet , whereas no change in the forearm blood flow , both at rest and in the postischaemic phase , was detected . Conclusions : These preliminary results indicate that HP diet was found to be not useful in increasing the muscle mass in comparison to a NP intake . In contrast to this , the latter diet seems to enhance the endothelial function of the arterial vessels with a more pronounced dilatation of the lumen in response to the increase in blood flow",
"BACKGROUND : We have previously reported that a fat-reduced high-protein diet had more favourable effects on body weight loss over 6 months than a medium-protein diet . OBJECTIVE : To extend this observation by a further 6–12 months less stringent intervention and a 24 months follow-up . DESIGN : A r and omised 6 months strictly controlled dietary intervention followed by 6–12 months dietary counselling period , and a subsequent 24 months follow-up , comparing an ad libitum , fat-reduced diet ( 30 % of energy ) either high in protein ( 25 % of energy , HP ) or medium in protein ( 12 % of energy , MP).SUBJECTS : A total of 50 overweight and obese subjects ( age : 19–55 y ; BMI : 26–34 kg/m2 ) . MEASUREMENTS : Change in body weight , body composition and blood parameters . RESULTS : After 6 months , the HP group ( n=23 ) achieved a greater weight loss than the MP group ( n=23 ) ( 9.4 vs 5.9 kg ) ( P the weight loss was not significantly greater among the subjects in the HP group ( 6.2 and 4.3 kg ) , but they had a 10 % greater reduction in intra-abdominal adipose tissue and more in the HP group ( 17 % ) lost > 10 kg than in the MP ( P 12 months weight loss , but more than 50 % were lost to follow-up . CONCLUSION : A fat-reduced diet high in protein seems to enhance weight loss and provide a better long-term maintenance of reduced intra-abdominal fat stores ",
"Influence of diet composition on mood during weight-reducing diets was studied in healthy young women of normal weight . A broad range of macronutrient intake was achieved by means of divergent dietary instructions for the composition of a 1,000 kcal per day diet adhered to for six weeks . Global mood during the last three weeks of the diet was significantly better in the “ vegetarian ” than in the “ mixed ” diet group . During this time a significant correlation was observed between relative carbohydrate intake and global mood ( r=−0.74 ; p the ratio of plasma tryptophan to other large neutral amino acids ( a predictor of tryptophan flow into brain ) and global mood ( r=− 0.52 ; p carbohydrate intake . It is hypothesized that impairment of central serotonergic function due to reduced tryptophan availability can prompt mood deterioration in situations of relatively low carbohydrate intake",
"A frequently cited concern of very-low-carbohydrate diets is the potential for increased risk of renal disease associated with a higher protein intake . However , to date , no well-controlled r and omized studies have evaluated the long-term effects of very-low-carbohydrate diets on renal function . To study this issue , renal function was assessed in 68 men and women with abdominal obesity ( age 51.5+/-7.7 years , body mass index [ calculated as kg/m(2 ) ] 33.6+/-4.0 ) without preexisting renal dysfunction who were r and omized to consume either an energy-restricted ( approximately 1,433 to 1,672 kcal/day ) , planned isocaloric very-low-carbohydrate ( 4 % total energy as carbohydrate [ 14 g ] , 35 % protein [ 124 g ] , 61 % fat [ 99 g ] ) , or high-carbohydrate diet ( 46 % total energy as carbohydrate [ 162 g ] , 24 % protein [ 85 g ] , 30 % fat [ 49 g ] ) for 1 year . Body weight , serum creatinine , estimated glomerular filtration rate and urinary albumin excretion were assessed before and after 1 year ( April 2006-July 2007 ) . Repeated measures analysis of variance was conducted . Weight loss was similar in both groups ( very-low-carbohydrate : -14.5+/-9.7 kg , high-carbohydrate : -11.6+/-7.3 kg ; P=0.16 ) . By 1 year , there were no changes in either group in serum creatinine levels ( very-low-carbohydrate : 72.4+/-15.1 to 71.3+/-13.8 mumol/L , high-carbohydrate : 78.0+/-16.0 to 77.2+/-13.2 mumol/L ; P=0.93 time x diet effect ) or estimated glomerular filtration rate ( very-low-carbohydrate : 90.0+/-17.0 to 91.2+/-17.8 mL/min/1.73 m(2 ) , high-carbohydrate : 83.8+/-13.8 to 83.6+/-11.8 mL/min/1.73 m(2 ) ; P=0.53 time x diet effect ) . All but one participant was classified as having normoalbuminuria at baseline , and for these participants , urinary albumin excretion values remained in the normoalbuminuria range at 1 year . One participant in high-carbohydrate had microalbuminuria ( 41.8 microg/min ) at baseline , which decreased to a value of 3.1 microg/min ( classified as normoalbuminuria ) at 1 year . This study provides preliminary evidence that long-term weight loss with a very-low-carbohydrate diet does not adversely affect renal function compared with a high-carbohydrate diet in obese individuals with normal renal function",
"CONTEXT Consolidation and maintenance of peak bone mass in young adulthood may be compromised by inactivity , low dietary calcium , and diet-induced weight loss . OBJECTIVE We aim ed to determine whether higher intakes of dairy foods , dietary calcium , and protein during diet- and exercise-induced weight loss affected markers of bone health . PARTICIPANTS Participants included premenopausal overweight and obese women . DESIGN /INTERVENTION Ninety participants were r and omized into three groups ( n = 30 per group ) : high protein and high dairy ( HPHD ) , adequate protein and medium dairy ( APMD ) , and adequate protein and low dairy ( APLD ) , differing in dietary protein ( 30 , 15 , or 15 % of energy , respectively ) , dairy foods ( 15 , 7.5 , or and dietary calcium ( ∼1600 , ∼1000 , or MEASURES Serum and urine bone turnover biomarkers , serum osteoprotegerin ( OPG ) , receptor activator of nuclear factor-κB lig and ( RANKL ) , PTH , 25-hydroxyvitamin D , leptin , and adiponectin measured at 0 and 16 wk . RESULTS All groups lost equivalent body weight ( P 0.05 ) . N-telopeptide , C-telopeptide ( CTX ) , urinary deoxypyridinoline , and osteocalcin increased in APLD ( P , osteocalcin and procollagen 1 amino-terminal propeptide ( P1NP ) increased ( P all resorption markers remained unchanged . P1NP to CTX and OPG to RANKL ratios increased in HPHD ( P , and P1NP to CTX ratio decreased in APLD ( P 0.05 ) . PTH decreased in HPHD and APMD vs. APLD ( P ) , and 25-hydroxyvitamin D increased in HPHD ( P ) . Leptin decreased and adiponectin increased in APMD and HPHD only ( P < 0.001 ) . CONCLUSIONS Hypoenergetic diets higher in dairy foods , dietary calcium , and protein with daily exercise , favorably affected important bone health biomarkers vs. diets with less of these bone-supporting nutrients",
"OBJECTIVE The long-term effect of dietary protein on bone mineralization is not well understood . RESEARCH METHODS AND PROCEDURES Sixty-five overweight ( body mass index , 25 to 29.9 kg/m(2 ) ) or obese ( > or = 30 kg/m(2 ) ) subjects were enrolled in a r and omized , placebo-controlled , 6-month dietary-intervention study comparing two controlled ad libitum diets with matched fat contents : high protein ( HP ) or low protein ( LP ) . Body composition was assessed by DXA . RESULTS In the HP group , dietary-protein intake increased from 91.4 g/d to a 6-month intervention mean of 107.8 g/d ( p Total weight loss after 6 months was 8.9 kg in the HP group , 5.1 kg in the LP group , and none in the control group . After 6 months , bone mineral content ( BMC ) had declined by 111 + /- 13 g ( 4 % ) in the HP group and by 85 + /- 13 g ( 3 % ) in the LP group ( not significant ) . Loss of BMC was more positively correlated with loss of body fat mass ( r = 0.83 ; p loss of body weight . Six-month BMC loss , adjusted for differences in fat loss , was greater in the LP group than in the HP group [ difference in LP vs. HP , 44.8 g ( 95 % confidence interval , 16 to 73.8 g ) ; p body weight and composition during the intervention , highprotein intake was associated with a diminished loss of BMC ( p Body-fat loss was the major determinant of loss of BMC , and we found no adverse effects of 6 months of high-protein intake on BMC",
"OBJECTIVE The ability to accurately identify articles about therapy in large bibliographic data bases such as EMBASE is important for research ers and clinicians . Our study aim ed to develop optimal search strategies for detecting sound treatment studies in EMBASE in the year 2000 . METHODS H and search es of journals were compared with retrievals from EMBASE for c and i date search strategies . Six trained research assistants review ed fifty-five journals indexed in EMBASE and rated articles using purpose and quality indicators . C and i date search strategies were developed for identifying treatment articles and then tested , and the retrievals were compared with the h and - search data . The operating characteristics of the strategies were calculated . RESULTS Three thous and eight hundred fifty articles were original studies on treatment , of which 1,256 ( 32.6 % ) were method ologically sound . Combining search terms revealed a top performing strategy ( r and om:.tw . OR clinical trial:.mp . OR exp health care quality ) with sensitivity of 98.9 % and specificity of 72.0 % . Maximizing specificity , a top performing strategy ( double-blind:.mp . OR placebo:.tw . OR blind : .tw . ) achieved a value over 96.0 % , but with compromised sensitivity at 51.7 % . A 3-term strategy achieved the best optimization of sensitivity and specificity ( r and om:.tw . OR placebo:.mp . OR double-blind:.tw . ) , with both these values over 92.0 % . CONCLUSION Search strategies can achieve high performance for retrieving sound treatment studies in EMBASE",
"BACKGROUND Very low-carbohydrate ( LC ) diets are often used to promote weight loss , but the long-term effects on psychological function remain unknown . METHODS A total of 106 overweight and obese participants ( mean [ SE ] age , 50.0 [ 0.8 ] years ; mean [ SE ] body mass index [ calculated as weight in kilograms divided by height in meters squared ] , 33.7 [ 0.4 ] ) were r and omly assigned either to an energy-restricted ( approximately 1433 - 1672 kcal [ to convert to kilojoules , multiply by 4.186 ] ) , planned isocaloric , very low-carbohydrate , high-fat ( LC ) diet or to a high-carbohydrate , low-fat ( LF ) diet for 1 year . Changes in body weight , psychological mood and well-being ( Profile of Mood States , Beck Depression Inventory , and Spielberger State Anxiety Inventory scores ) , and cognitive functioning ( working memory and speed of processing ) were assessed . RESULTS By 1 year , the overall mean ( SE ) weight loss was 13.7 ( 1.8 ) kg , with no significant difference between groups ( P = .26 ) . Over the course of the study , there were significant time x diet interactions for Spielberger State Anxiety Inventory , Beck Depression Inventory , and Profile of Mood States scores for total mood disturbance , anger-hostility , confusion-bewilderment , and depression-dejection ( P Working memory improved by 1 year ( P speed of processing remained largely unchanged , with no effect of diet composition on either cognitive domain . CONCLUSIONS Over 1 year , there was a favorable effect of an energy-restricted LF diet compared with an isocaloric LC diet on mood state and affect in overweight and obese individuals . Both diets had similar effects on working memory and speed of processing . Trial Registration anzctr.org.au Identifier : 12606000203550"
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BACKGROUND Mild-moderate hypertension during pregnancy is common . Antihypertensive drugs are often used in the belief that lowering blood pressure will prevent progression to more severe disease , and thereby improve outcome . OBJECTIVES To assess the effects of antihypertensive drug treatments for women with mild to moderate hypertension during pregnancy . SEARCH STRATEGY Relevant trials were identified in the register of trials maintained by the Cochrane Pregnancy and Childbirth Group . In addition , the Cochrane Controlled Trial Register , MEDLINE , and EMBASE were search ed . Date of last search : October 2000 . SELECTION CRITERIA All r and omised trials evaluating any antihypertensive drug treatment for mild to moderate hypertension during pregnancy , defined whenever possible as systolic blood pressure 140 - 169 mmHg and diastolic blood pressure 90 - 109 mmHg . Comparisons were of one or more antihypertensive drug(s ) with placebo , with no antihypertensive drug , or with another antihypertensive drug , and where treatment was planned to continue for at least seven days . DATA COLLECTION AND ANALYSIS Data were extracted independently by two review ers . MAIN RESULTS Overall , this review includes 40 studies ( 3797 women ) , 24 of which compared an antihypertensive drug with placebo/no antihypertensive drug ( 2815 women ) . There is a halving in the risk of developing severe hypertension associated with the use of antihypertensive drug(s ) [ 17 trials , 2155 women ; relative risk ( RR ) 0.52 ( 95 % confidence interval ( CI ) 0.41 to 0.64 ) ; risk difference ( RD ) -0.09 ( -0.12 to -0.06 ) ; number needed to treat ( NNT ) 12 ( 9 to 17 ) ] but little evidence of a difference in the risk of pre-eclampsia [ 19 trials , 2402 women ; RR 0.99 ( 0.84 to 1.18 ) ] . Similarly , there is no clear effect on the risk of the baby dying [ 23 trials , 2727 women ; RR 0.71(0.46 to 1.09 ) ] , preterm birth [ 12 trials , 1738 women ; RR 0.98 ( 0.85 to 1.13 ) ] , or small for gestational age babies [ 17 trials , 2159 women ; RR 1.13 ( 0.91 to 1.42 ) ] . There were no clear differences in any other outcomes . Seventeen trials ( 1182 women ) compared one antihypertensive drug with another . There is no clear difference between any of these drugs in the risk of developing severe hypertension , and proteinuria/pre-eclampsia . Other antihypertensive agents seem better than methyldopa for reducing the risk of the baby dying [ 14 trials , 1010 subjects , RR 0.49 ( 0.24 to 0.99 ) ; RD -0.02 ( -0.04 to 0.00 ) ; NNT 45 ( 22 to 1341 ) ] . Other outcomes were only reported by a small proportion of studies , and there were no clear differences . REVIEW ER 'S CONCLUSIONS It remains unclear whether antihypertensive drug therapy for mild-moderate hypertension during pregnancy is worthwhile
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"OBJECTIVE --To compare the effects of uteroplacental circulation of two beta adrenoceptor blockers , atenolol ( cardioselective ) and pindolol ( non-selective with intrinsic sympathomimetic activity ) . DESIGN --Controlled double blind double dummy study . SETTING --Departments of obstetrics and gynaecology in two Swedish university hospitals . SUBJECTS--29 women with pregnancy induced hypertension in the third trimester , 13 r and omised to atenolol and 16 to pindolol . MAIN OUTCOME MEASURES --Pulsatility index in fetal aorta , umbilical artery , and maternal arcuate artery . Volumetric blood flow in fetal aorta and umbilical vein . RESULTS --Mean arterial blood pressure decreased by 9.0 ( 95 % confidence interval -13.0 to -5.0 ) mm Hg in the atenolol group and by 7.8 ( -11.4 to -4.2 ) mm Hg in the pindolol group . During atenolol treatment the pulsatility index increased significantly from 1.82 ( SD 0.20 ) to 2.07 ( 0.32 ) in the fetal thoracic descending aorta , from 1.44 ( 0.28 ) to 1.79 ( 0.27 ) in the abdominal aorta , and from 0.93 ( 0.17 ) to 1.05 ( 0.19 ) in the umbilical artery ; the volumetric blood flow in the umbilical vein decreased from 106 ( 28.8 ) to 84 ( 22.6 ) ml/min/kg . No such changes were seen after treatment with pindolol . Birth weight was similar in the two groups but placental weight was significantly different ( 529 ( 122 ) g in atenolol group v 653 ( 136 ) g in pindolol group ; p = 0.03 ) . CONCLUSION --The hypotensive effect was similar with both drugs , but only the beta 1 blocker atenolol had significant effects on fetal haemodynamics , although within normal ranges . The implication s of these findings can be only speculative , but negative fetal consequences of beta 1 adrenoceptor blockade can not be excluded",
"OBJECTIVE Our purpose was to study the effects of isradipine , a dihydropyridine calcium channel blocker , on mother and fetus in the treatment of hypertensive disorders of pregnancy . STUDY DESIGN The investigation was performed as a two-group , parallel , double-blind multicenter study of isradipine versus placebo . Fifty-four women were r and omized to treatment with isradipine slow-release capsules given orally 5 mg twice a day and 57 to a placebo group . RESULTS Isradipine lowered the maternal mean arterial blood pressure effectively in women with nonproteinuric hypertension but did not do so in women with proteinuria at recruitment or appearing during treatment . Blood flow in the umbilical artery and maternal renal and liver function were not influenced by treatment . Isradipine had few side effects and was well tolerated . CONCLUSION Calcium channel blockade with isradipine is effective for treatment of nonproteinuric hypertension but not in preeclampsia",
" 195 ( 97.5 % ) children born to hypertensive women participating in a trial of methyldopa treatment during pregnancy were followed from birth and were extensively examined at the age of 7 1/2 years . The frequency of problems with health , physical or mental h and icap , sight , hearing , and behaviour was the same in children of treated and untreated women . Sons of the untreated women were heavier and taller than those of treated women , as were their mothers . Among children of women who entered the trial between 16 and 20 weeks ' gestation , sons of untreated women had larger heads than sons of treated women , but there was no difference in mean intelligence quotients . There were no significant differences between the children in the treated and untreated groups in st and ing and supine blood pressures , or fourteen tests of ability . Methyldopa therefore seems safe to use in pregnancy and is probably preferable to other drugs from the point of view of the neonate and child",
"One hundred and eighty three hypertensive pregnant women were r and omly assigned to antihypertensive treatment with oxprenolol ( 96 women ) or methyldopa ( 87 women ) . Control of hypertension was equivalent in both treatment groups , and in 64 ( 35 % ) cases hydralazine had to be added to the treatment to achieve the therapeutic goal ( diastolic blood pressure below 85 mm Hg ) . Five perinatal deaths occurred , one in the oxprenolol group and four in the methyldopa group . Detailed analysis confirmed a previous report of greater fetal growth in the group treated with oxprenolol ; this trend was present regardless of severity of hypertension and parity . With increasing duration of treatment the differences between the two groups diminished , and there was no difference after 10 weeks of treatment , a finding that may explain some of the reported discrepancies among therapeutic studies . As hypertension in pregnancy may pursue an accelerated course , necessitating urgent delivery , and there is no satisfactory method of predicting the duration of treatment in individual patients fetal benefit is most likely to be achieved by treatment with oxprenolol , provided that there is no maternal contraindication to treatment with beta blockers",
"OBJECTIVE The effects of two antihypertensive drugs , methyldopa and isradipine , on fetal heart rate pattern were analyzed by computerized cardiotocography . STUDY DESIGN The first part of the study was a prospect i ve , r and omized , controlled trial of 19 women with preeclampsia in the third trimester given 2.5 mg of oral slow-release isradipine twice a day or 250 mg of methyldopa three times a day . In a second part of the study 23 women with preeclampsia in the third trimester given 5 mg of oral slow-release isradipine twice a day were compared with 23 matched controls without medication . Main outcome measures were maternal blood pressure and mean baseline fetal heart rate , fetal movements , number of accelerations , periods of high and low baseline variability , and mean baseline heart rate variability . RESULTS Compared with the pretreatment value , the mean arterial blood pressure decreased significantly in all drug treatment groups . Fetal heart rate characteristics were not significantly changed during drug treatment or bed rest . CONCLUSION The various features of the fetal heart rate pattern evaluated by computerized methods were not influenced by treatment with methyldopa or isradipine",
"To test the effects of calcium dobesilate ( Doxium ) in pregnancies complicated with pregnancy-induced hypertension or mild/moderate pre-eclampsia a double-blind , placebo-controlled pilot study was carried out . Primigravida patients ( gestational age ≤34 weeks ) daily took 2 g Doxium or placebo until delivery . Twelve patients received placebo for 53 days , and 11 patients took the drug for 57 days on average . At the start of the study 2 patients in the placebo group ( PG ) and 8 in the Doxium group ( DG ) had pre-eclampsia . The mean arterial pressure ( mean ± SD ) significantly decreased from 118 ± 7 to 99 ± 9 mm Hg in the DG ( p = 0.003 ) , while in the PG it had slightly increased by the end of the study . Proteinuria was higher in the DG at the start but not at the end ; however , significant changes of this parameter were detected in neither of the groups throughout the study . Fibronectin decreased significantly in both groups but it was more pronounced in the DG ( 23.8 vs. 9.4 % ) . Changes of platelet count , plasma and blood viscosity , and erythrocyte deformability were favourable in the DG but in the PG these parameters had deteriorated although the alterations were not significant . No marked differences were found between the two groups regarding fetal well-being , courses of deliveries , and the neonatal period . Neither maternal nor fetal/neonatal side effects were noticed . It seems that Doxium favourably influences the blood pressure and consequently decreases the requirement for medication and hospitalisation in cases of mild to moderate midtrimester hypertension",
"In a prospect i ve study , women who were hypertensive before the 28th wk of gestation were r and omly allocated into two groups : those who received specific hypotensive therapy ( Ht ) and those who did not ( Hu ) . The outcome was compared with a r and om sample of the hospital population ( S ) ascertained after delivery . In both hypertensive groups there was a higher incidence of clinical signs of possible fetal distress and instrumental delivery . Although there was no difference between the groups in the distribution of birthweight above and below the mean for gestational age , the treated hypertensive group had an excess of infants with relatively smaller head circumferences for their gestational age compared with both the untreated hypertensive group and the hospital sample . Tube-feeding was also more frequent in the treated hypertensive group . In the untreated hypertensive group there were more infants whose neurological status was categorized as question able or abnormal in the neonatal period , compared with the sample . The different problems encountered by infants in the two hypertensive groups emphasized the need for further study of these babies . Their development during the first year of life will be examined in a subsequent paper",
"OBJECTIVE The main purpose of our study was to analyse efficacy and safety of acebutolol ( Sectral ) in the treatment of hypertension in pregnancy . DESIGN Cohort clinical study comparing efficacy and safety of acebutolol with other antihypertensive drugs by 77 patients and their 81 newborns . The number of 48 patients were treated by acebutolol . SETTING Internal Medicine and Clinical Pharmacology Department , Regional Hospital , Nitra and The Faculty of Health Service and Social Work , University of Trnava ; Department of Gynaecology and Obstetrics , Regional Hospital Nitra and The Faculty of Health Service and Social Work , University of Trnava ; Institute of Pharmacology , The Faculty of Medicine , Komenského University , Bratislava ; Environment , a.s . Nitra . METHODS During the period of 6 years our patients were divided into subgroups according to the type of hypertension in pregnancy and the severity of the illness which was the basis for used antihypertensive drugs . One of the topics of the study was to provide monitoring of adverse events by mother and possible drug influence on their new-born has been evaluated by investigating the week of birth , weight and length of the new-born and evaluating of Apgar score . RESULTS In the subgroup of 48 women treated by acebutolol we have confirmed the efficacy and safety of this antihypertensive drug without any clinical ly significant effect on the quality of life of their new-born and evaluating of Apgar score . CONCLUSION With regard to the results of our clinical study we can consider acebutolol to be effective and safe antihypertensive drug in the treatment of hypertension in pregnancy",
"OBJECTIVE --To determine the effect of atenolol on the outcome of pregnancy in women with essential hypertension . DESIGN -- Prospect i ve , r and omised , double blind , placebo controlled study . SETTING --Hospital clinic . PATIENTS --33 Women with mild essential hypertension ( systolic blood pressure 140 - 170 mm Hg or diastolic pressure 90 - 110 mm Hg on two occasions at least 24 hours apart ) consecutively referred to two obstetric medical clinics . Four patients in the placebo group were withdrawn from the study : control of blood pressure was inadequate in two , one developed breathlessness , and one changed her mind about participating . The mean gestation in the 29 remaining women on entry to the study was 15.9 weeks . MAIN OUTCOME MEASURES --Blood pressure and birth weight . INTERVENTION--14 Women received placebo . 15 Women received atenolol 50 mg daily initially , increasing until either the blood pressure was less than 140/90 mm Hg or a dose of 200 micrograms daily was reached . RESULTS --The mean blood pressure on entry was 148/86 mm Hg in the group given atenolol and 144/86 mm Hg in the group given placebo . During treatment the mean diastolic pressure was significantly reduced by atenolol compared with placebo ( to 74 v 81 mm Hg ; difference in means ( 95 % confidence interval ) 7.0 ( 2.9 to 10.0 ) mm Hg ) but the effect on systolic pressure was marginal ( 132 v 136 mm Hg ; 4.0 ( -1.4 to 8.6 ) mm Hg ) . Babies in the atenolol group had a significantly lower birth weight than those in the placebo group ( 2620 g v 3530 g ; 910 ( 440 to 1380)g ) . CONCLUSION --Atenolol given from the end of the first trimester in patients with mild hypertension is associated with intrauterine growth retardation . When taken in conjunction with the results of a previous study in which methyldopa was given these findings indicate that benefit is unlikely to result from treating mild essential hypertension in pregnancy",
" A placebo-controlled trial was used to assess the antihypertensive efficacy of indoramin in the management of pregnancy hypertension . Sixty patients were recruited into the study and only 17 attained satisfactory blood pressure control . In the doses of drugs administered indoramin was not shown to be more effective than alpha-methyldopa",
"OBJECTIVE To determine the haemostatic status in preeclampsia and to investigate the effects of short-term use of anti-hypertensive drugs , methyldopa and isradipine . METHODS Thirty preeclamptic ( PE ) women admitted to the hospital for observation and treatment were r and omized to receive either methyldopa or isradipine for 2 weeks . Their blood pressure were monitored for 24 h before treatment and again at 7 days and 14 days after treatment using the programmable automated ambulatory blood pressure ( ABP ) monitoring system . Blood sampling was performed before commencement of anti-hypertensive treatment , 7 days and 14 days after treatment and the haemostatic parameters studied was compared before treatment with normal pregnancy and the effect of anti-hypertensive treatment . Nineteen normal pregnant subjects with a total of 30 blood sampling at various gestation and good pregnancy outcome served as controls . The following haemostatic parameters were determined ; thrombelastography , fibrinogen , antithrombin III ( ATIII ) , thrombin-antithrombin (TAT)-complex , beta-thromboglobulin ( beta-TG ) , plasminogen activators ( t-PA , u-PA ) , plasminogen activator inhibitors ( PAI-1 , PAI-2 ) , and plasminogen . RESULTS Significant lowering of blood pressure was evident at Days 7 and 14 of therapy with either methyldopa or isradipine . Increased mean plasma fibrinogen and decreased ATIII levels were seen in preeclampsia together with decreased u-PA and t-PA activity levels in contrast to increased t-PA antigen and beta-TG . No significant differences were seen for TAT-complex , PAI-1 , plasminogen and D-dimer levels although their mean levels were higher than observed in non-pregnant subject except for PAI-2 , the level was significantly reduced when compared with normal pregnancy . Two-way analysis of variance showed no significant alteration on all haemostatic parameters studied in preeclamptic women receiving either methyldopa or isradipine after 7 and 14 days of therapy . CONCLUSION Enhance activation of coagulation was observed together with raised fibrinolysis in normal pregnancy and PE . However , in PE a further reduction in ATIII , u-PA and PAI-2 with increased fibrinogen and platelet activation could lead to an imbalance in the coagulation/fibrinolysis equilibrium which favours fibrin deposition . All these changes seen in PE including the coagulation kinetics were not altered by the short term effects of methyldopa and isradipine even though significantly lowered blood pressure were observed during therapy",
"OBJECTIVE To assess the efficacy and safety of labetalol compared with methyldopa in the management of mild and moderate cases of pregnancy-induced hypertension ( PIH ) . METHODS One hundred four primigravidas with PIH were r and omly allocated to receive either labetalol ( group A ) or methyldopa ( group B ) . The dose of the drugs was doubled every 48 h to maintain a mean arterial blood pressure Clinico-biochemical effects and frequency of side effects were studied . The statistical level of significance was taken at P significant proteinuria ( > 30 mg/dl ) whereas none developed proteinuria in group A. Labetalol was quicker and more efficient at controlling blood pressure , having a beneficial effect on renal functions and causing fewer side effects compared with methyldopa . The rate of induction of labor and rate of cesarean section for uncontrolled PIH was less in group A ( 48 % and 1 % , respectively ) compared with group B ( 63.0 % and 5.6 % , respectively ) . Moreover a higher Bishop score at induction of labor was noticed in group A. CONCLUSIONS Labetalol is better tolerated than methyldopa , gives more efficient control of blood pressure and may have a ripening effect on the uterine cervix",
"Twenty-five patients whose pregnancies were complicated by chronic hypertension were entered in a double-blind study and r and omly allocated to treatment with methyldopa ( Aldomet ) or placebo . Thirteen patients were in the treatment group and 12 in the placebo group . The two groups showed no significant difference in demographic and pretreatment laboratory profiles . Methyldopa-treated patients registering in the first trimester had a significant reduction in the mean arterial pressure ( MAP ) during the second and third trimesters ( P less than 0.025 ) . No significant differences in birth weight ( BW ) , ponderal index ( PI ) were found when results were corrected for gestational age ( GA ) , race , and sex . The mean GA was significantly prolonged in the methyldopa-treated group by 10.3 days ( P less than 0.05 ) . The frequency of superimposed pre-eclampsia was similar in both groups ( 33.3 % vs. 38.4 % ) . However , 75 % of the superimposed pre-eclampsia occurred antepartum in the placebo group , while 80 % of the methyldopa-treated group developed superimposed pre-eclampsia intrapartum . The results of this small study suggest that the treatment of hypertension in pregnancy may reduce MAP and possibly delay the occurrence of superimposed pre-eclampsia and thus afford a prolongation of the pregnancy",
"The patients with preeclampsia undergoing emergent cesarean section is always a challenge to an anesthesiologist , because severe hypertensive response after laryngoscopy and tracheal intubation may result in life-threatening complication such as cerebral hemorrhage . Most of these patients receive magnesium sulfate for the prevention of convulsion . An ideal anti-hypertensive drug for preeclampsia should be effective , limited fall in blood pressure , rapid onset , maintaining uteroplacental blood flow , and less maternal and fetal side effects . We studied the efficacy of 10 mg sublingual nifedipine in attenuating the pressor response to intubation . We were also concerned about whether this calcium antagonist may inhibit uterine contraction and increase intra and postpartum hemorrhage when it is used with magnesium sulfate and general anesthesia . There were thirty-three patients in our study ( 16 in nifedipine group and 17 in control group ) . This study revealed that nifedipine attenuate the hypertensive response effectively . Uterine contraction response to oxytocic drugs was quite well in both groups . There was no significant difference in blood loss between nifedipine and control group . And no severe maternal and fetal adverse effect",
"Summary . The effect of nifedipine on uteroplacental blood flow was investigated in nine hypertensive women in the third trimester of pregnancy and compared with the effects of a placebo in nine similar hypertensive women . An index of uteroplacental blood flow was obtained , twice before treatment and once after treatment , by measuring the increase in radioactivity in the region of the placenta with a gamma camera following an intravenous injection of indium‐113 m . There was no significant change in the blood flow index in either the nifedipine‐ or the placebo‐treated groups despite a significant fall in blood pressure with nifedipine . Nifedipine lowers the blood pressure without any apparent reduction in uteroplacental blood flow",
"Summary . Intravenous treatment with 10 mg of hydralazine or 100 mg of labetalol was r and omly allocated to 30 hypertensive pregnant women . Umbilical artery flow velocity waveforms were recorded using a pulsed Doppler duplex scanner ( ATL Mk V ) and umbilical artery pulsatility index ( PI ) and fetal heart rate ( FHR ) were derived from these recordings . Maternal blood pressure decreased significantly after both drugs . Maternal pulse rate increased after hydralazine but did not change significantly after labetalol . FHR did not change significantly after hydralazine but decreased after labetalol . PI decreased after hydralazine and increased after labetalol‐most fetuses showed little change but a few in each group showed large changes in PI , as did two of five additional patients studied . We attributed the decrease in PI in some fetuses after hydralazine to vasodilation , and the increase in PI in some fetuses after labetalol to vasoconstriction in the fetoplacental circulation , suggesting that fetal beta‐blockade may occur after maternal treatment with labetalol ",
"Atenolol was compared with placebo in a r and omised and double-blind prospect i ve study of 120 women with mild to moderate pregnancy-associated hypertension who were also initially managed conventionally by bed rest . Atenolol given once daily significantly reduced blood-pressure , prevented proteinuria , and reduced the number of hospital admissions . Loss of blood-pressure control leading to withdrawal from the study was commoner among the placebo group , whose babies had a high morbidity . Respiratory distress syndrome occurred only in the placebo group . Intrauterine growth retardation , neonatal hypoglycaemia , and hyperbilirubinaemia occurred with the same frequency in the two groups . Neonatal bradycardia was more common after atenolol but the systolic blood-pressure of the babies was the same in both groups . There was no difference between the groups in maternal symptoms which could have been attributed to beta-blocker therapy . Thus atenolol is more effective than conventional obstetric management in this form of hypertension and does not adversely affect mother or baby",
"The effect of nifedipine 5 mg administered sublingually to pregnant hypertensive patients was examined in a r and omised controlled double-blind study . The effect on maternal blood pressure and the fetal umbilical artery Doppler waveform was studied for 30 minutes before and 30 minutes after administration of the drug or placebo . This dose result ed in a significant drop in maternal blood pressure 30 minutes after administration and did not result in a significant change in the Doppler umbilical artery waveform ( in fetuses with normal waveforms ) when compared with a control group",
"The objective of this study was to evaluate the effect of low dose magnesium supplement upon maternal and fetal serum levels of mineral status in pregnancies complicated with hypertension ( PIH ) . Twenty-five patients with PIH agreed to participate and were r and omly allocated , in a double-blind manner , either to intravenous magnesium for 2 days followed by oral magnesium ( n = 12 ) until delivery or placebo ( n = 13 ) . In women supplemented with magnesium the level of magnesium increased from 0.74 to 1.02 mmol/l during the first 24 h of inclusion and simultaneously we observed an increased urinary loss of magnesium . Serum level and the urinary excretion of magnesium returned to pretreatment level at delivery . Maternal magnesium supplement increased the concentrations of magnesium in umbilical cord and neonatal blood 1 day after delivery . Serum ionized calcium did not change during the study period despite a significant increased loss of calcium during the first 24 h of inclusion . Low dose maternal magnesium treatment did not cause neonatal hypocalcemia",
"Ninety‐seven women with moderate to severe preeclampsia ( PE ) were allocated at r and om to labetalol or hydralazine treatment . Of these , 22 women with severe PE gave birth to neonates with VLBW ( very low birth weight ≥ 1500 g ) . Seven were allocated to labetalol treatment ( Group A ) , eight to hydralazine treatment ( Group B ) and seven women received both drugs due to poor blood pressure control with a single drug therapy ( Group C ) . No difference in cesarean section rate or in the indication for operative delivery could be seen . Gestational age was 29.9 weeks ( 25.4–32.5 ) in Group A. 28.6 weeks ( 26.6–33.4 ) in Group B and 27.3 weeks ( 26.7–31.1 ) in Group C ( median and range ) . Birth weight did not differ between groups and 13 of the 22 infants weighed below 1000 g. There was a tendency to lower Apgar scores at five minutes in the hydralazine group . Time spent in the neonatal intensive care unit did not differ between groups . Five of the 11 neonates with gestational age (GA)≥28 weeks and three of the seven neonates in GA 29–30 weeks died . Neither the number of infants requiring intermittent positive pressure ventilation or duration of O2‐treatment , nor number of infants with respiratory distress syndrome differed between groups . We did not find any difference in the outcome of the VLBW infants when the hypertensive mother had been treated with either hydralazine or labetalol ",
"Fifty-one women with pregnancy-induced hypertension ( PIH ) were r and omly allocated to one of three treatment groups : A : hydralazine ( 13 ) ; B : hydralazine and propranolol ( 17 ) ; and C : hydralazine and pindolol ( 19 ) . All women fulfilled the pretreatment criteria and were of similar age , numbers of previous pregnancies and had systolic blood pressure ( SBP ) of between 140 and 160 mmHg and diastolic blood pressure ( DBP ) of between 95 and 110 mmHg . Hypertension was treated equally well by all three regimens ( mean SBP was 133.6 , 130 and 134 mmHg , respectively ) . Heart rate was significantly higher than baseline in group A and lower in groups B and C , as is to be expected with beta-blocker treatment . Side-effects were more frequent in group A than in groups B and C , 62 % of the patients on hydralazine monotherapy complained of palpitations compared to 35 % on combination treatment . Fetal outcome differed in the various groups . Birth weight was significantly lower in group B , where regimen included propranolol , compared to that of group C , for whom the regimen included pindolol ( 3,044.7 + /- 443.8 and 2,709.6 + /- 485.5 gm , p Mean blood glucose of the newborns were similar in groups A and C ( 76.5 + /- 16.5 and 78.6 + /- 15 gm% ) and significantly lower in group B ( 62.6 + /- 14 gm% , p blood pressure was equally well treated in all three treatment groups . However , more maternal side-effects occurred in group A , the group treated with hydralazine monotherapy , while propranolol in combination with hydrazaline ( group B ) had some negative effects on fetal development which did not occur in pindolol/hydrazaline combination",
"The obstetric implication s of the use of the beta-adrenoceptor antagonist atenolol have been evaluated in a prospect i ve , r and omized , double-blind , and placebo-controlled study involving 120 women with pregnancy-associated hypertension . The clinical interpretation of antenatal and intrapartum cardiotocographs was uninfluenced by atenolol . Human placental lactogen concentration fell in the atenolol group , but this was not an indicator of subsequent fetal distress . Other obstetric indices , such as urinary estriol excretion , were the same in both groups . Spontaneous premature labor occurred in five women receiving placebo but in none who received atenolol . Together with previously reported findings on pregnancy outcome , our study leads us to conclude that beta-blockers such as atenolol can appropriately be used in the management of hypertension during pregnancy",
"We compared propranolol with methyldopa in a r and omized prospect i ve study of 28 women with pregnancy associated hypertension . Both drugs were equally effective in controlling maternal hypertension . There was no significant difference in the birthweights of the babies in each group . However one infant born to a mother receiving propranolol had symptomatic hypoglycaemia . The mean peak levels of propranolol , propranolol glucuronide , 4-hydroxypropranolol , and 4-hydroxypropranolol glucuronide were not significantly different in the first , second , third trimesters and at least 3 months post partum . The mean peak plasma level of naphthoxylactic acid however was significantly less in the third trimester compared with post partum levels . Propranolol and its metabolites were found to cross into breast milk with the maximum dose likely to be ingested by the infant as either propranolol or propranolol glucuronide being 7 micrograms of propranolol per 100 g of breast milk , being approximately 0.1 % of the maternal dose",
"A controlled prospect i ve evaluation of pregnancy complicated by chronic hypertension is proposed and preliminary data on population selection and pregnancy outcome are presented . Sixty-three women with evidence of underlying hypertensive disease were followed prospect ively throughout pregnancy . Twenty-three patients were followed in a protocol of intensified prenatal care and r and omized assignment of antihypertensive agents : placebo , hydralazine , or methyldopa . Forty patients were followed in the high-risk pregnancy clinics at Duke University . The incidence of preeclampsia in the r and omized prophylactic antihypertensive group was statistically lower than that in the nonr and omized group ( 8.7 versus 32.5 % ; P 63 hypertensive women had a high incidence of diabetes mellitus diagnosed during pregnancy ( 49.2 % ) as compared to the authors ' general obstetric population ( 8.1 % )",
"Atenolol and bisoprolol , two beta-1-selective blockers , were compared in patients with mild and medium severe hypertension . Forty patients with a diastolic blood pressure of 95 - 115 mm Hg were two weeks after discontinuation of treatment divided at r and om into two groups treated with 50 mg atenolol and 5 mg bisoprolol . If the blood pressure was not affected by this dosage , the dose was raised to 100 mg atenolol and 10 mg bisoprolol . The blood pressure readings , heart rate , side effects of the drugs , laboratory and echocardiographic values were followed up for a period of three months . The authors recorded a marked decline of pressure and heart rate after the first week of therapy , the pressure readings in an upright position did not differ statistically from values in a sitting position , orthostatic hypotension was not recorded . The rate of success of bisoprolol was 85 % , of atenolol 75 % . During treatment no serious side-effects were observed . The biochemical parameters and echocardiographic values were not altered significantly by treatment . Atenolol and bisoprolol are two effective beta-1-selective blockers with a comparable effect in the treatment of mild and medium severe hypertension . They are useful in monotherapy as well as in combination with other antihypertensive drugs . In hypertension associated with diabetes mellitus , incipient bronchopulmonary disease and pregnancy they are also indicated . They are well tolerated also by elderly patients , an advantage of bisoprolol may be that it has a smaller impact on pressure and heart rate during the night",
"Our objective was to determine if maternal urinary calcium excretion is altered during treatment of mild preeclampsia remote from term with the calcium channel blocker nifedipine . One hundred forty-eight women with mild preeclampsia were r and omly allocated to treatment with either bed rest alone ( n=64 ) or in combination with nifedipine ( n=84 ) at 26 - 36 weeks ' gestation . All women had 24 hr urine sample s collected for creatinine clearance and calcium excretion determination prior to therapy and during treatment . There was no difference in gestational age at the time of urine collection between the two groups . There were no differences in 24-hr creatinine clearance and calcium excretion between the groups prior to therapy . When followed longitudinally , there was a significant reduction in calcium excretion within each group ( p=0.0005 control group , p reduction in calcium excretion was noted following nifedipine therapy ( 62+/-94 mg Ca/24 hr ) compared to the control group ( 143+/-153 mg Ca/24 hr ) , p progressive hypocalciuria is a feature of preeclampsia . Further , urinary calcium excretion decreased despite nifedipine therapy . Altered urinary calcium excretion may be less reflective of the progression in severity of preeclampsia in patients treated with nifedipine",
"In a double blind study , 20 gravidas with pre-eclampsia were r and omly allocated to treatment with either propranolol 120 mg/day or pindolol 15 mg/day for 7 days . Flow velocimetry was performed before and after treatment to assess the influence of these two regimens of beta blocker on the feto-placental circulation . A continuous wave Doppler unit was used to measure umbilical and uterine artery flow velocity waveforms . The systolic/diastolic ( A/B ) ratio and the systolic minus diastolic divided by systolic (A-B)/A ratio ( resistance index ) were used as indexes of blood flow resistance in the umbilical and uterine arteries , respectively . A resistance to flow in the uteroplacental circulation was significantly less in patients treated with pindolol compared to those treated with propranolol ( P less than 0.01 ) . The same pattern was also found in umbilical velocimetry , although the statistical significance was borderline ( P = 0.06 ) . Although both drugs were equally effective in reducing blood pressure at rest , their effect on the peripheral resistance was different . Pindolol appears to act in part through a peripheral vascular mechanism . Our data support this assumption because the flow in the uteroplacental bed , as reflected by a decrease in resistance index , improved when patients were treated with the drug pindolol",
"OBJECTIVE To assess the effects of nimodipine on retinal blood flow in patients with pregnancy induced hypertension ( PIH ) . METHODS Fourteen patients were studied with color flow Doppler before and after 30 mg nimodipine administered orally , while other fourteen patients received intravenous magnesium sulfate as control group . Central retinal artery flow velocity waveforms were measured and pulse index ( PI ) were calculated . RESULTS Nimodipine reduced the central retinal artery PI significantly from 0.92 + /- 0.14 to 0.75 + /- 0.22 . It also reduced systolic blood pressure from 20.7 + /- 2.5 kPa to 19.8 + /- 1.5 kPa and diastolic blood pressure from 14.4 + /- 2.3 kPa to 13.6 + /- 1.9 kPa . CONCLUSIONS Nimodipine may dilate central retinal arteries . Changes in pulsatility index in retinal arteries maybe indicative of similar changes in other cerebral vessels . Nimodipine may be another choice of PIH therapy",
"Calcium channel blockers have been used successfully in the treatment of pregnancy hypertension and premature labor . Only limited information related to their effect on uterine blood flow during pregnancy is available . In this study we measured the ratio between peak systolic to end-diastolic flow velocity ( S/D ratio ) in the ascending branch of the uterine artery in nine pregnant patients prior to and following a 10-mg dose of sublingual nifedipine . Another group of seven matched patients who received a placebo served as a control group . All studies were performed between 17 and 22 weeks gestation . The S/D ratio decreased shortly after sublingual nifedipine , but the change was not significant . It increased gradually afterward so that by 60 minutes it returned to the control value . The mean systolic blood pressure decreased by 8.6 % to its lowest value after 25 minutes ( P less than 0.01 ) . The mean diastolic blood pressure decreased by 15.7 % to its lowest value after 35 minutes ( P less than 0.002 ) . Maternal heart rate did not change significantly . No significant changes were observed in any of the measured variables in the placebo group . In conclusion , nifedipine does not induce significant changes in uterine arterial resistance in midtrimester and may be considered during pregnancy , providing that large fluctuations in maternal blood pressure are avoided",
"OBJECTIVE The objective of our study was to test the hypothesis that treatment with nifedipine for mild preeclampsia remote from term reduces the number of days of maternal hospitalization and improves pregnancy outcome . STUDY DESIGN A total of 200 patients at 26 to 36 weeks ' gestation were r and omly allocated to treatment with either bed rest alone ( n = 100 ) or bed rest in combination with nifedipine ( n = 100 ) . RESULTS Patients receiving nifedipine had significantly lower systolic ( p diastolic ( p blood pressures during therapy . Severe hypertension as an indication for delivery was significantly ( p maternal hospitalization ( 12.6 + /- 7.9 vs 12.3 + /- 10.3 ) and pregnancy prolongation ( 22.3 + /- 13.5 vs 22.5 + /- 15.7 ) . There were no differences between groups with respect to birth weight , incidences of small-for-gestational-age infants and preterm birth , number of days spent in special care unit , or cord blood gas measurement . CONCLUSION Nifedipine therapy for preeclampsia reduces maternal blood pressure but does not reduce number of days of maternal hospitalization or improve perinatal outcome",
"In a controlled trial pregnant women who were hypertensive before the 28th week of gestation were r and omly allocated to treatment with methyldopa or no anti‐hypertensive treatment . The children from these pregnancies have been re‐examined at four years of age and their development compared with a r and om sample from the same maternity hospital population . Their health , height , weight , and the incidence of sight , hearing and speech problems did not differ . None had gross neurological abnormalities . Boys in the treated hypertensive group had significantly smaller heads than in the other two groups , but there was no correlation between head circumference and developmental score in this group ( r = 0.020 ) . On average the children in the r and om sample were the most advanced when assessed a global score of development . In each developmental sector the mean score for the treated hypertensive group was consistently higher than the untreated hypertensive group . We conclude that maternal hypertension is associated with slight developmental delay in early childhood . There are some indications that treatment with methyldopa may reduce this effect",
"Two hundred primigravid women with mild preeclampsia at 26 - 35 weeks ' gestation were r and omly allocated to treatment with hospitalization alone or combined with labetalol . There were no differences between the two groups in mean systolic or diastolic pressures , mean gestational age , or initial laboratory findings at time of entry . Patients in the labetalol group demonstrated a statistically significant ( P less than .005 ) decrease in blood pressure during treatment . No such decrease occurred in the hospitalization-alone group . Both groups exhibited significant deterioration in proteinuria , creatinine , and uric acid . The average days of pregnancy prolongation ( mean + /- SD ) were 21.3 + /- 13 and 20.1 + /- 14 days in the hospitalization and labetalol groups , respectively . There were no differences between the groups regarding any of the following : gestational age at delivery , birth weight , number of infants admitted to the special care unit , or cord blood gas measurements . However , the incidence of small-for-gestational-age infants was significantly higher in the labetalol group ( 19 versus 9 % , P less than .05 ) . There were no stillbirths , but one neonatal death in the labetalol group . Treatment of maternal blood pressure in preeclamptic pregnancies with labetalol did not improve perinatal outcome , and was associated with a higher frequency of fetal growth retardation",
"Abstract . in an open , controlled trial , treatment with a combination of metoprolol and hydralazine was compared with non‐pharmacological management of mild and moderate hypertension in pregnancy . One hundred and sixty‐one women participated in the study . the drug‐treated group showed significantly better blood pressure control than the group not given antihypertensives . Induction of labor before term , because of maternal or fetal complications , was somewhat more frequent in the control group . Nine women in the treatment group and 5 in the control group developed albuminuria . Three infants in the drug‐treated group died perinatally , and one in the control group . the outcome for the newborns was similar in both groups concerning birth weight , head circumference and Apgar score and in the frequencies of respiratory distress , bradycardia and hypoglycemia . the better blood pressure control achieved with these drugs makes it possible to treat the patient at home and reduce the risk of emergency delivery , but treatment does not seem to be m and atory for a good outcome of the pregnancy in cases of mild and moderate hypertension during pregnancy",
"The therapeutic effect of the calcium antagonist ; Nifedipine was assessed in 30 patients with pre-eclampsia . Cases were r and omly allocated into two groups ; a study group ( n = 20 ) who received Nifedipine capsules ( 20 mg every 8 h for 7 days ) and a control group ( n = 10 ) who received placebo capsules with the same regimen . After Nifedipine administration , there was a significant decrease in blood pressure , serum urea and creatinine and 24 h urinary proteins . No significant difference was found in FHR and S/D ratio of the umbilical artery between study and control groups or between initial values and after Nifedipine administration . Preliminary results indicated that Nifedipine decreased blood pressure and improved kidney functions without affecting the umbilical artery blood flow in cases of pre-eclampsia",
"OBJECTIVE To study the effect of prepared rhubarb in treating patients with pregnancy induced hypertension ( PIH ) and its therapeutic mechanisms . METHODS Prepared rhubarb and nifedipine were given to the study group , while the nifedipine was given to the control group alone . The blood lipid , renal function , blood coagulation , fibrinolysis and immunological parameters were monitored . RESULTS In the study group , ( 1 ) Levels of triglycerides ( TG ) and low density lipoprotein-cholesterol ( LDL-C ) decreased and high density lipoprotein-cholesterol ( HDL-C ) level increased significantly ; ( 2 ) Plasma level of fibronectin ( FN ) and plasminogen activator inhibitor ( PAI ) lowered significantly , plasma antithrombin ( AT-III ) level unchanged ; ( 3 ) Serum beta 2 microglobulin ( beta 2-MG ) level and urinary level of N-acetyl-beta-D-glucosaminidase ( NAG ) and interleukin-6 ( IL-6 ) decreased significantly ; ( 4 ) CD8 of blood increased , CD4/CD8 and circulating immune complex ( CIC ) of blood reduced obviously . All of the above-mentioned parameters in the study group were significantly different from that of the control group . CONCLUSION The prepared rhubarb could reduce the vascular endothelial cell 's damage significantly and alter the immune balance , which is effective in treating the PIH",
"The placenta and the umbilical cord obtained from 18 women with pregnancy‐induced hypertension were investigated by light microscopy . The umbilical artery was studied by electron microscopy . 10 placentae and umbilical cords from normal pregnancies served as controls . The study was performed as a double‐blind r and omized controlled study in which 11 women were allocated to magnesium and 7 to placebo treatment . The treatment comprised a 48‐hour intravenous magnesium/placebo infusion followed by daily oral magnesium/placebo intake until one day after delivery . Magnesium supplement increased birth weight and placental weight significantly . Light microscopic study of the placentae and the umbilical cord arteries showed no difference between the three groups concerning the occurrence of infa rct ions , cytotrophoblastic hyperplasia , vasculo‐syncytial membranes , basement membrane thickening , stromal fibrosis or intervillous fibrin . Ultrastructurally , the endothelial cells of the umbilical arteries from women with pregnancy‐induced hypertension showed a significant increase in the amount of dilated endoplasmatic reticulum and basal laminae thickness when all 18 cases were compared with the controls . There was no significant difference when the magnesium group , the placebo group and the control group were compared separately . The present study suggests that magnesium supplement has a benefical effect on fetal growth in pregnancy‐induced hypertension . With regard to the light and electron microscopic changes we were unable to demonstrate any significant difference between the magnesium , placebo and control groups",
"A total of 242 women with moderate hypertension in pregnancy completed a controlled trial of methyldopa ( Aldomet ) . The hypotensive effect of methyldopa was similar to its action in non‐pregnant individuals and greatly reduced the frequency of severe hypertension occurring antenatally and in labour . As pregnancy advanced , an increasing daily dose of methyldopa was needed and there was a greater use of additional hypotensive therapy . Seventeen ( 14·5 per cent ) women assigned to methyldopa had to be transferred to another drug or had to stop treatment completely because of minor side effects , of which the commonest were lack of energy and dizziness . No serious side effects were encountered . Nine per cent of the untreated women developed severe hypertension which required treatment later in their pregnancies . Six weeks after delivery , nearly all the patients were able to stop",
"Forty-four consecutive patients referred for treatment because of hypertension ( greater than 150/90 mmHg ) occurring during pregnancy were r and omly allocated to one of two treatment groups , hydralazine alone ( n = 21 ) or hydralazine combined with pindolol ( n = 23 ) . Satisfactory blood pressure control ( diastolic pressure less than 90 mmHg ) was achieved in 86 % of patients receiving hydralazine alone and 91 % of those on combined therapy . Although the treatment did not lower the overall incidence of hypertensive complications it appeared to delay the onset of such complications until successful surgical intervention was possible . Fetal outcome was similar in both groups and there was no perinatal mortality in this high-risk population . Although blood pressure control was similar in both groups of patients , combined therapy with hydralazine and pindolol can be considered to be superior to hydralazine monotherapy , since in patients treated with the combination the incidence and intensity of troublesome side-effects was markedly lower",
"Objective To compare the effect of routine treatment with the calcium channel blocker nifedipine in mild to moderate hypertension in pregnancy",
"Summary . Two treatment strategies were compared in 155 women with pregnancy‐induced hypertension who were also given comprehensive non‐pharmacological care . The mean gestation at entry was 28 weeks . As long as the diastolic blood pressure ( DBP ) remained below 106 mmHg , oxprenolol , or oxprenolol plus dihydralazine , were given to the early treatment group , and matching placebos to the control group . Open antihypertensive treatment was provided for patients whose DBP rose above 105 mmHg . Proteinuria occurred in seven women in each group . In the early treatment group , 13 of the 78 women were delivered by caesarean section ; the corresponding numbers in the control group were 27 of 76 ( 17 vs 36 % , 95 % confidence interval ( CI ) of difference : 5‐33 % ) ; the sections included seven and 16 in the early treatment and control groups , respectively , for severe hypertension and /or fetal distress . There were five perinatal deaths , two in the early treatment group and three in the control group . Early treatment did not influence gestational age at birth or birthweight . Respiratory distress syndrome occurred in four infants in the early treated group and in 10 in the control group ; 14 infants in the former group and 26 in the latter were in hospital for more than 10 days ( 18 vs 35 % ; 95 % CI of difference 4.32 % ) . These results indicate that early antihypertensive treatment with oxprenolol is safe for the fetus and newborn in pregnancy‐induced hypertension , but has no advantage over non‐pharmacological care in terms of fetal growth . However , it may prevent acute hypertension in late pregnancy and associated fetal distress , and thus reduce the number of caesarean sections",
"This is a prospect i ve r and omised controlled study in 21 women admitted with preeclampsia in the third trimester . The mean arterial blood pressure decreased by 11.1 mmHg ( 95 % confidence interval -14.9 to -7.3 mmHg ) in the methyldopa group , and by 9.3 mmHG ( 95 % confidence interval-14.4 to -4.2 mmHG ) in the isradipine group . The maternal heart rate decreased by 6.9 beats per min ( 95 % confidence interval -11.6 to -2.2 bpm ) during methyldopa treatment , and by 2.5 beats per min ( 95 % confidence interval -9.2 to 4.3 ) during isradipine treatment . Pulsatility index in maternal and fetal vessels was not affected by either of the two drugs . The birth weight and placental weight and neonatal outcome were similar and uneventful . The hypotensive effect was similar for methyldopa and isradipine . Except reduced maternal heart rate on methyldopa , fetal and uteroplacental hemodynamics were not altered during treatment of preeclampsia with methyldopa or isradipine",
"OBJECTIVE To determine the efficacy of Nifedipine on postpartum blood Loss in patients with Pregnancy Induced Hypertension ( PIH ) . METHODS 64 cases of PIH were r and omly divided into study group ( n = 32 ) and control group ( n = 32 ) . Before labor Nifedipine 10 mg-20 mg was given three time daily for all cases . In study group Nifedipine was taken orally every 6 hours during the labor course until the end of second stage . In control group Nifedipine was not given in the labor stages . The postpartum blood loss was collected and measured carefully within 2 hours after delivery . RESULTS The amount of pastpartum hemorrhage was ( 359.1 + /- 136.6 ) ml in study group which was significantly higher than that of control group ( 268.5 + /- 110.7 ) ml P postpartum hemorrhage rate in study and control group was 43.75 % and 18.75 % respectively . The difference was statistically significant ( P Nifedipine for PIH cases can increase the amount of postpartum blood loss and rate of postpartum hemorrnage",
"We compared the flow velocity waveforms of uterine and umbilical arteries in normotensive and pre-eclamptic patients at mid-gestation . In a r and omised controlled trial we tested the effects of isosorbide dinitrate ( ISDN , nitric oxide donor ) patch therapy on the flow velocity waveform of pre-eclamptic patients at mid-gestation . The resistance indices ( RI ) of human uterine and umbilical arteries were higher in pre-eclamptic patients compared to the normotensive patients . ISDN patch therapy significantly reduced the increased RI values of the umbilical artery in pre-eclamptic patients without any change in systemic blood pressures , but the RI values of the uterine artery were not significantly attenuated . The change of the umbilical artery might be due to the improvement of end-diastolic flow velocity . These results suggest that the feto-placental circulation in pre-eclampsia , perhaps due to the disturbance of the endothelium-dependent vaso-relaxation system , and that ISDN therapy may improve the impaired endothelium dependent nitric oxide system",
"> Objective : To determine the effects of ketanserin given from early in the midtrimester of pregnancy on fetal heart rate parameters later in pregnancy . Methods : Patients with diastolic blood pressure persistently higher than 80 mm Hg between 12 and 20 weeks ' gestational age were r and omized to receive either ketanserin or placebo . Both groups also got 75 mg of aspirin per day . The fetal heart rate was monitored once every fortnight from 28 weeks ' gestation and weekly from 36 weeks onward . Recordings were made with the Sonicaid System 8000 and continued until the Dawes and Redman criteria were met . Results : The Dawes and Redman criteria were met within 10 min in 54 % of recordings in both study groups , whereas they were not met in 4.5 and 3.3 % of recordings in the ketanserin group and placebo group , respectively ( P = 0.58 ) . The mean time to meet these criteria duration per recording was 16.9 min in the ketanserin group and 16.2 min in the placebo group ( P = 0.83 ) . There were no significant differences between the two study groups in fetal heart rate variability , accelerations , or decelerations before 38 weeks ' gestation . Thereafter the mean minute range and short-term and baseline variability were significantly higher in the ketanserin group , and significantly more accelerations of the fetal heart were recorded in the ketanserin group . Conclusions . Ketanserin does not influence the fetal heart rate adversely and may even be associated with improved recordings late in pregnancy",
"Twentysix women with pregnancy-induced hypertension have been r and omly treated with either labetalol or Aldomet . A more satisfactory control of blood pressure was obtained with labetalol with minimal side-effects . After two weeks of treatment with labetalol renal function had significantly improved with a markedly lower incidence of proteinuria . More patients went into spontaneous labour following labetalol than following Aldomet ; the Bishop score was also higher in this group . No adverse effects attributable to labetalol were noted in the baby either ante- or post-natally",
"It is the development of proteinuria in pregnancy-induced hypertension which is associated with an increased perinatal mortality . There is some evidence to suggest that labetalol may diminish the amount of proteinuria in patients who have already developed proteinuric pre-eclampsia . A r and omised controlled study design was used to investigate whether labetalol treatment , started when a persistent diastolic blood pressure greater than 90 mmHg was observed , influenced the subsequent development of proteinuria . One hundred and fourteen women with singleton pregnancies and hypertension in the absence of proteinuria were r and omised to receive either labetalol or no antihypertensive therapy . At recruitment maternal age , blood pressure and gestation were similar in both the labetalol and control groups . There was no difference in the frequency , quantity or timing of subsequent proteinuria between treatment and control groups . Overall 34 % of primigravidae and 10 % of parous women developed proteinuria . Labetalol did , however , control the blood pressure in 45 of the 51 treated women ( 88 % ) within 24 h. This effect was often shortlived requiring dose escalation after 3 to 5 days in the majority of cases . Labetalol was well tolerated and no significant maternal toxicity was noted",
"OBJECTIVE To compare nifedipine ( group 1 ) with methyldopa ( group 2 ) in the management of pregnancy induced hypertension ( PIH ) . DESIGN A prospect i ve clinical trial . SETTING Obstetric Unit , General Hospital , Peradeniya . PATIENTS A total of 126 patients with PIH were allocated alternately to either group . The patients in group 1 received nifedipine 30 to 90 mg/day and in group 2 methyldopa 750 to 2000 mg/day . MEASUREMENTS Blood pressure , the extra days added to the pregnancy , number of patients treated for acute hypertensive episodes , maturity of fetus at birth , mode of delivery , birth weight , intrauterine deaths , Apgar score , maternal side effects and complications . RESULTS The two groups on admission to the study had similar periods of gestation ( group 1 , 33.6 + 5.9 , group 2 , 34.1 + 4.2 ) , systolic blood pressure in mmHg ( 151 + 22 , and 154 + 24 ) and diastolic blood pressure ( 108 + 12 , and 108 + 12 ) . The results showed no differences between the two groups , with respect to maturity of fetus at delivery ( 35.1 + 5.5 , and 35.7 + 2.9 ) , mode of delivery , number of intrauterine deaths , average systolic blood pressure in mmHg ( 148 + 14 and 152 + 16 ) , average diastolic blood pressure ( 102 + 8 and 104 + 9 ) , highest systolic blood pressure ( 169 + 24 and 167 + 30 ) , highest diastolic blood pressure ( 115 + 12 and 116 + 11 ) , birth weight in kg ( 2.015 + 0.957 , and 1.922 + 0.660 ) and number of days added to the pregnancy ( 7 + 7 , 9 + 11 ) . The Apgar score for group 2 was better than in group 1 , and less patients in group 2 required treatment for acute hypertension during the period of study . CONCLUSIONS The results of our study indicate that nifedipine is as effective as methyldopa in the treatment of PIH",
"This is an evaluation of the methodology of blood pressure measurement in a high-risk obstetric clinic . Blood pressure values were obtained from 149 patients by the clinic staff and the research project coordinator . The project coordinator using the r and om-zero sphygmomanometer measured lower systolic and higher diastolic values . The diastolic and systolic values increased after 30 weeks of pregnancy up to term . Agreement among observers is low for diastolic blood pressure . The clinic staff measured about 50 % of the values with a zero terminal digit as compared with only 14 % by the project coordinator . The fourth Korotkoff sound can be recorded in 83 % of the patients . The mean diastolic blood pressures obtained with the fourth sound are significantly higher than when the fifth sound is used . Recommendations are offered for blood pressure measuring during pregnancy , and it is strongly suggested that the same method ologic rigor be used as in any other medical procedure",
"Objective To compare the effects of treatment with nicardipine and metoprolol in patients with hypertension during pregnancy",
"Thirty patients matched for age , parity , socioeconomic status and severity of pregnancy induced hypertension ( PIH ) were r and omly allocated to treatment with metoprolol or methyldopa . The average fall in diastolic blood pressure was significant in the group treated with metoprolol as compared with the methyldopa group ( p less than 0.01 ) . There were 3 perinatal deaths in the methyldopa group and 1 in the metoprolol group ; the mean birth weight of the babies was higher in cases treated with metoprolol . The results suggest metoprolol to be more efficacious with regard to control of hypertension and fetal outcome in cases of pregnancy induced hypertension",
"OBJECTIVES To evaluate the efficacy of methyldopa in the treatment of mild pre-eclampsia , to prevent its progress and to investigate its effect on the pregnancy outcomes . DESIGN S R and omised clinical trial . SETTING Wad Medani Hospital in the central Sudan . SUBJECTS Seventy primigravidae with single , alive baby of 28 - 36 weeks gestational age suffering from true mild pre-eclampsia were enrolled . The patients were r and omised in two groups , treatment group who received methyldopa 750 - 4000 mg/day ( n=34 ) and a control group who received no treatment ( n=36 ) . All the ( treatment and control ) patients were drug followed as in- patients till the delivery , seen with their babies on the days 7 , 42 after the delivery . MAIN OUTCOMES MEASURES The outcomes examined were , rise of the diastolic blood pressure to 110 mm Hg or more , occurrence of imminent eclampsia or the eclampsia , if the maturity could be achieved , occurrence of intrauterine growth retardation , abruptio placentae , mode of delivery , birth weight , placental weight , perinatal death , Apgar score and referral of the babies to the pediatrician . RESULTS Three out of 34 ( 8.8 % ) of the treatment group had a rise in the diastolic blood pressure of 110 mm Hg , 18/36 ( 50 % ) of the control had a rise in the diastolic blood pressure of 110 mmHg ( p imminent eclampsia , while 10/36 ( 27.8 ) of the control group developed imminent eclampsia ( p maturity was achieved in 82.3 % and 88.8 % of the treatment and the control , respectively ( p > 0.05 ) . There were ten ( 14.2 % ) perinatal deaths , four of them in the treatment group , while six in the control ( p > 0.05 ) . There was no difference regarding birth weight , occurrence of intrauterine growth retardation , placental weight , mode of delivery , Apgar score , referral of the babies to the paediatrician . No patient developed eclampsia or abruptio placenta ; there was no maternal death in both groups . CONCLUSION Methyldopa can prevent the progress of the mild pre-eclampsia to severe pre-eclampsia , without affecting the maturity , birthweight or the neonatal outcomes",
"One hundred pregnant women with hypertension ( defined as diastolic blood pressure at or above 95 mm Hg ) were allocated at r and om to treatment with methyldopa or oxprenolol and were compared with nonhypertensive controls matched according to parity and gestation at delivery . The patients were also stratified into those entering the study early ( before 32 weeks ' gestation ) and those entering late ( after 32 weeks ' gestation ) . Although there were no differences in diastolic blood pressure between the hypertensive groups before or during treatment , in the early entry group the systolic blood pressure at entry of those allocated to oxprenolol was significantly higher than that of those receiving methyldopa ; this difference remained throughout the treatment period . Also in the early entry group further increments of drug treatment were required to control blood pressure of patients receiving oxprenolol than in those receiving methyldopa . The eventual fetal outcome for all patients treated with methyldopa was the same as that for those treated with oxprenolol ; birth weight , placental weight , head circumference , and Apgar score were not significantly different and there were no stillbirths in either group",
"The objective of the present study is to compare the effectiveness of transdermal glyceryl-trinitrate versus oral nifedipine in lowering blood pressure in patients affected by pregnancy-induced hypertension ( PIH ) . Thirty-six consecutive pregnant women have been evaluated at different gestational ages after the diagnosis of PIH or preeclampsia ( PE ) . After a 24-h ambulatory blood pressure monitoring , patients were allocated to three groups : those receiving oral nifedipine and those receiving transdermal glyceryl-trinitrate in a continuous ( 24 h/day ) or intermittent ( 16 h/day ) administration . A second blood pressure monitoring was performed after 2 weeks of treatment . Systolic and diastolic blood pressure were compared by using the Cosinor method looking at mesor , amplitude , and acrophase . Baseline systolic and diastolic blood pressure was similar among the three groups . Neither the transdermal glyceryl-trinitrate administered for 24 or 16 h nor oral nifedipine affected systolic and diastolic blood pressure . Analysis of variance showed that the posttreatment values were similar among the groups . Further studies are needed to verify the possible use of transdermal glyceryl-trinitrate as an antihypertensive drug during pregnancy",
" 1 . This study evaluates the perinatal outcome of infants born to ninety‐five mothers with hypertension in pregnancy whose blood pressure was treated in a double blind trial comparing clonidine hydrochloride ( C ) and α‐methyldopa ( A )",
"Objectives : Although magnesium is now the drug of choice for the prevention of eclamptic seizures only few studies have evaluated whether magnesium may reduce blood pressure in pregnancies complicated with hypertension . Methods : A total of 33 patients with pregnancy-induced hypertension were r and omized to either magnesium or methyldopa treatment . Of these 16 received magnesium and 17 methyldopa . The treatment comprised a 48-hour magnesium infusion followed by oral magnesium tablets until 3 days after delivery or 250 mg methyldopa 4 times a day in a similar period . Results : Patients treated with magnesium had 1 day after inclusion a statistically significantly lower systolic blood pressure compared to the level in the methyldopa group ( 138.1 ± 11 vs. 147.6 ± 11 mm Hg ; p observed in diastolic blood pressure ( 92.0 ± 6.6 vs. 96.0 ± 10.1 mm Hg ; NS ) . From the 5th day of inclusion and until delivery both systolic and diastolic blood pressure were significantly lower in the magnesium group ( p all blood pressure measurements in a single analysis showed that both systolic ( 138 ± 13 vs. 148 ± 15 mm Hg ; p 0.0001 ) and diastolic ( 92 ± 10 vs. 94 ± 10 mm Hg ; p were lower in the magnesium group compared to the methyldopa group . There was no difference between the two groups regarding gestational age at delivery , birth weight , Apgar scores and pH in umbilical cord blood . Conclusion : This preliminary study demonstrates that magnesium treatment lowers blood pressure in pregnancies complicated with hypertension . The effect is without any adverse effect on maternal and neonatal well-being",
" The growth and development of three groups of infants were prospect ively assessed from birth to 12 mth . In two groups the mothers had been hypertensive before the 28th wk of gestation ; one group was r and omly allocated to specific hypotensive therapy , the other group was allocated to no specific treatment . The third group was a sample of the hospital population . General health , and the incidence of sight and hearing problems did not differ . Infants in the treated hypertensive group had had more perinatal problems , and there was an excess of infants with relatively small heads for their gestational age at birth . At 6 mth their heads were still smaller than the hospital sample , but by the age of 1 yr the difference was no longer present . The neurological status of infants in the untreated hypertensive group was less favourable in the neonatal period , and there was still an excess of infants in this group rated question able on neurological assessment at the age of 12 mth . In both hypertensive groups there was an excess of infants with delayed fine-motor function at 6 mth , and in the untreated group there was an excess with delayed gross-motor function at 12 mth compared with the hospital sample . Our varied findings draw attention to the dangers of assessing the effects of different pregnancy conditions in terms of neonatal mortality and morbidity alone . Our date indicate that follow-up should extend for longer than 12 mth when the effects of adverse pregnancy factors and their management are under consideration . Further evaluation will be made when these children are 4 yr old",
"A prospect i ve , double-blind , r and omized controlled trial was carried out , comparing α-methyldopa and clonidine hydrochloride in 100 pregnant women with hypertension . There was no difference in hypotensive effect or reported maternal side effects with either agent . There was one neonatal loss in each group ( 98 % survival ) . Neither drug caused clinical ly significant hypotension nor rebound hypertension in the neonates . Clonidine hydrochloride , like methyldopa , appears to be a safe antihypertensive agent in pregnancy",
"Abstract . A review is presented as regards the neonatal effects of beta‐blocking agents in hypertension during pregnancy . Experience points to low fetal and neonatal risks , but firmly based data concerning the neonates are very scanty . An on‐going double‐blind study is presented in which pregnant women with hypertension are r and omly allocated to either metoprolol or placebo treatment . One of the aims is to study the postnatal adaptation of the infants . The following measurements , recordings and examinations are performed : anthropometric measurements , Apgar score , blood gases and acid‐base status in umbilical ( venous and arterial ) blood , lactate and hypoxanthine in umbilical venous blood , catecholamines in umbilical arterial blood , pulse rate , blood glucose and a quantitative neurobehavioral assessment in the neonatal period",
"The antihypertensive efficacy of acute treatment with the serotonin receptor antagonist , ketanserin , in women with preeclampsia has been recently documented . The purpose of this study was to determine the safety and efficacy of chronic ketanserin treatment in a group of 20 hypertensive pregnant women : 10 received daily oral doses of ketanserin ( 20 - 80 mg ) , and 10 were treated with oral alpha-methyldopa ( 500 - 2000 mg ) . This study includes ( a ) patients with a sustained elevation of systolic blood pressure higher than 159 mm Hg and /or diastolic blood pressure higher than 99 mm Hg at bed rest , and ( b ) hypertensive patients with systolic blood pressure higher than 140 mm Hg or diastolic blood pressure higher than 90 mm Hg with superimposed symptoms such as headaches , stomach aches , and neurological disturbances . A significant and comparable decrease in blood pressure was noted in both groups , in relation with pretreatment levels ; no adverse affects were observed in mother or fetus from the ketanserin and alpha-methyldopa groups",
"BACKGROUND Ketanserin , a selective serotonin-2 receptor antagonist , decreases systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) in non-pregnant patients with hypertension , but not in normotensive subjects . Its effect on longitudinal blood pressure ( BP ) patterns in pregnant women has not been documented . OBJECTIVES To assess how ketanserin , given orally , influences maternal BP during pregnancy . DESIGN A double-blind r and omised controlled trial where patients with DBP > or = 80 mmHg between 12 and 20 weeks ' gestation received either ketanserin or placebo . SETTING Tygerberg Hospital , a tertiary referral unit in the Western Cape . SUBJECTS One hundred and two patients who received their study drug for at least 140 days during pregnancy . Patients requiring additional antihypertensive medication were excluded from the analysis . OUTCOME MEASURES Changes in SBP and DBP in relation to gestational age and days since entering the study . RESULTS The mean DBP over the total period was significantly lower in the ketanserin group ( 77 + /- 8.7 mmHg v. 80.8 + /- 9.1 mmHg ) . The decline in DBP was 9.2 mmHg in the ketanserin group and 5.3 mmHg in the placebo group . These differences were detected from within 7 days of therapy and persisted for most of the pregnancy . The mean SBP did not differ at any stage , although the mean fall in SBP was significantly greater in the ketanserin group ( 8.6 + /- 16.7 v. 4.1 + /- 17.1 mmHg ) . CONCLUSIONS Ketanserin decreased DBP during pregnancy significantly more than placebo",
"Cord blood IgE levels and the development of allergy were studied in 29 children born by mothers who had been treated with the beta-adrenergic receptor blocking agent , metoprolol , during the pregnancy and in 23 children of placebo-treated mothers . In 13 ( 45 % ) of the former and 3 ( 15 % ) of the placebo group elevated cord blood IgE levels , i.e. more than 0.9 kU/l and /or obvious or probable allergy developed ( p = 0.03 ) . The findings support previous experimental observations that beta-blocking agents may enhance IgE antibody formation . It also adds to the number of environmental factors that may increase the risk for atopic disease in children",
" 242 women completed a controlled trial of methyldopa ( ' Aldomet ' ) for moderate hypertension in pregnancy . Active treatment was associated with a significantly improved fetal outcome , due in part to a reduced number of mid-pregnancy abortions . There were 9 pregnancy losses in the control group , which included 4 mid-pregnancy abortions , and 1 fetal loss in the treated group . The birthweight and maturity of viable infants were similar in treated and control groups , and a detailed multivariate analysis confirmed that hypotensive treatment had no effect on fetal growth in utero . The better outcome associated with treatment was not due to the prevention of pre-eclampsia , and may be partly due to a direct or indirect effect of methyldopa on uterine activity . Methyldopa is safe to use for the treatment of hypertension in pregnancy in the context of close medical and obstetric supervision",
"Objective To determine the need for , and efficacy of , treatment with labetalol in women with mild‐to‐moderate pregnancy induced hypertension ( PIH )",
"We describe the results of a prospect i ve study in which 120 women who developed hypertension in the last trimester of pregnancy were r and omly allocated in double blind manner to atenolol or placebo . The mean duration of treatment was five weeks . The only difference between groups during the neonatal period was in respiratory distress syndrome , mainly related to spontaneous premature labour , which occurred in six placebo group babies but in none from the atenolol group . Fifty five children from each group have been followed to 1 year of age . All in the atenolol group are developing normally but one child from the placebo group is brain damaged . These findings do not suggest any short or medium term paediatric complications after the use of beta blockers in pregnancy",
"The safety of use of the calcium channel blocker nifedipine in pregnancy as it affects child development has not been well evaluated . We report the results , with regard to the safety for children of use of nifedipine in pregnancy , on children followed up at 18 months of age born from women recruited in a study comparing routine treatment with nifedipine compared with no treatment 1",
"BACKGROUND Pre-eclampsia is associated with extensive endothelial-cell damage and platelet activation , result ing in lower production of vasodilator prostagl and ins and increased release of the vasoconstrictors thromboxane A2 and serotonin . Damage to endothelial-cell serotonin-1 receptors leaves vasoconstriction and platelet aggregation mediated by serotonin-2 receptors unopposed . We investigated the role of ketanserin , a selective serotonin-2-receptor antagonist , in lowering the rate of pre-eclampsia among pregnant women with mild to moderate hypertension . METHODS We recruited 138 pregnant women into a double-blind , r and omised , placebo-controlled trial . They had diastolic blood pressure persistently more than 80 mm Hg before 20 weeks ' gestation . 69 women received ketanserin and 69 received placebo . Both groups also received aspirin . Patients were initially given two tablets daily , increased to four tablets daily in diastolic blood pressure was more than 90 mm Hg . Primary outcomes were the development of pre-eclampsia and severe hypertension , and perinatal mortality . FINDINGS There were significantly fewer cases of pre-eclampsia ( two vs 13 ; relative risk 0.15 [ 95 % CI 0.04 - 0.66 ] , p = 0.006 ) and severe hypertension ( six vs 17 ; p = 0.02 ) in the ketanserin than in the placebo group . There was also a trend towards less perinatal mortality ( one vs six deaths ) but this was not significant ( p = 0.28 ) . Rates of abruptio placentae and pre-eclampsia before 34 weeks ' gestation were lower in the ketanserin group , and mean birthweight was significantly higher . INTERPRETATION We found an association between the addition of ketanserin to aspirin and a decrease in the number of cases of pre-eclampsia and severe hypertension , as well as improved pregnancy outcome among patients with mild to moderate midtrimester hypertension",
"The effects of magnesium were compared with those of placebo in a r and omized double‐blind controlled study of 58 patients with pregnancy‐induced hypertension , of whom 27 received magnesium and 31 placebo . Twenty patients in each group were Noneiparas . The treatment comprised 48 h of either intravenous magnesium or placebo infusion followed by daily oral magnesium or placebo tablets until one day after delivery . Magnesium supplementation significantly reduced maternal mean arterial blood pressure ( MAP ) . The gestational age at delivery was the same in both groups , whereas the relative fetal birth weight among Noneiparas was reduced in the placebo group . Unbalanced analyses of variance suggested an influence of magnesium supplement on birth weight . The infants in the magnesium supplemented group spent fewer days in the neonatal intensive care unit . There were no perinatal deaths . Magnesium appeared to be beneficial in the management of pregnancy‐induced hypertension . The better outcome associated with magnesium supplementation may not have been due to reduction of MAP and further studies are needed to clarify whether magnesium influences birth weight",
"OBJECTIVE To evaluate the short-term effects of intravenously given atenolol and pindolol on utero- and umbilicoplacental vascular impedance , fetal hemodynamics and cardiac function in patients suffering from pregnancy-induced hypertension . STUDY DESIGN A total of 24 women were r and omized to receive atenolol or pindolol infusion . By using pulsed color Doppler techniques , uterine , placental arcuate , umbilical fetal middle cerebral and renal arteries were examined before , at the end and 30 min after the end of infusion . Pulsatility indices ( PI ) were calculated to assess vascular impedance . Fetal myocardial function was evaluated by using pulsed Doppler and M-mode echocardiography . Peak systolic velocities from the ascending aorta and pulmonary trunk , and also inner diameters and fractional shortenings of both ventricles were measured . RESULTS Both drugs significantly decreased maternal blood pressure . Immediately after the infusion , maternal heart rate was significantly decreased in both groups ; but the decrease was clearer and lasted longer in the atenolol group . Pindolol caused no changes in utero- or umbilicoplacental vascular impedance , while atenolol increased it in the nonplacental uterine artery . After atenolol infusion , PI in the umbilical artery was higher than after pindolol . Pindolol had no effects on fetal hemodynamics , while atenolol decreased PI value in the fetal renal artery . Peak systolic velocity in the pulmonary trunk was decreased after atenolol . Pindolol did not affect the fetal cardiac function . In subgroups with originally increased utero- or umbilicoplacental vascular impedance , the responses in uterine and umbilical vascular impedance and in fetal hemodynamics and cardiac function after atenolol and pindolol were different compared to whole groups . CONCLUSION Differently acting antihypertensive agents seem to affect differently uteroplacental vascular impedance . Atenolol may have some direct effects on fetal hemodynamics and cardiac function . According to our results , pindolol seems to be more preferable in the treatment of pregnancy-induced hypertension than atenolol",
"In a r and om controlled trial of methyldopa for the treatment of hypertension in pregnancy presenting before 28 weeks gestation , the newborn in the treated group had relatively smaller head circumferences . This difference persisted at two months of age when correction had been made for birth weight , gestation and sex , but was no longer detectable at six or twelve months . Within the treated group no relationship was found between neonatal head circumference and the total amount or duration of methyldopa received during pregnancy . Comparison of treated and untreated groups according to the time of entry to the study showed that significant differences in neonatal head circumference were only present in patients who entered between 16 and 20 weeks gestation . It is possible that this could be a sensitive period for the interaction of fetal head growth and the onset of specific treatment in hypertensive pregnancy",
"OBJECTIVE AND DESIGN The aim of this study was to evaluate treatment of mild to moderate hypertension ( less than 170/110 mmHg ) in pregnancy in a prospect i ve , r and omised , double-blind trial . SETTING AND PATIENTS Pregnancy outcome was studied for 52 primigravid women , managed in hospital from early in the third trimester . INTERVENTIONS Patients were r and omly allocated either to placebo or to active treatment ( clonidine plus hydralazine ) . MAIN OUTCOME MEASURES AND RESULTS Maternal deterioration dictated withdrawal from trial therapy for eight patients receiving placebo , but for only one receiving active treatment . Maternal proteinuria occurred only in the placebo group . Intention-to-treat analysis showed a significant increase in premature delivery for complications in the placebo group ( P less than 0.05 ) , despite active blood pressure treatment for those withdrawn from the group because of severe hypertension ( 170/110 mmHg or higher ) . Neonatal respiratory distress requiring intensive care occurred only in babies born to women in the placebo group . There were no perinatal deaths and no adverse effects of treatment in the neonates . CONCLUSIONS The study indicates that early control of mild hypertension in pregnancy can prevent progression to emergency premature delivery",
"Thirty-two consecutive women with pregnancy-induced hypertension of early onset were r and omly allocated to treatment with pindolol or methyldopa . There was no difference between the groups in regard to the average time of delivery ( 36.33 vs. 36.6 weeks ) and weight of the newborn ( 2850 vs. 2870 g ) . A significant drop in systolic ( P less than 0.005 ) and diastolic ( P less than 0.05 ) blood pressure was observed in the group of patients treated with pindolol as compared with the methyldopa group . In the pindolol group an improvement in renal function was observed as determined by CCT and serum creatinine . There were no side effects from the drugs in the mother or in the newborn",
"Abstract A controlled trial of bendrofluazide and methyldopa in 100 patients with hypertension in pregnancy is reported . In patients developing hypertension before twenty weeks of pregnancy treatment seemed to improve the chances of a successful outcome to the pregnancy . In those developing late hypertension treatment was of no value in the presence of proteinuria . The presence or absence of proteinuria seemed to be of more importance than the level of the diastolic pressure",
"Fifty-three pregnant women with moderately severe hypertension were r and omly allocated to treatment with methyldopa or oxprenolol . There were no significant differences between the groups in age , height , weight , parity , or stage of gestation at the start of treatment . The outcome of pregnancy was better in the group treated with oxprenolol , with greater maternal plasma volume expansion and placental and fetal growth . No intrauterine deaths occurred in either group , and antepartum fetal distress , detected by oxytocin challenge testing , was evident in only one patient , who received methyldopa . This infant , and one other in the methyldopa group , died in the neonatal period . No neonatal deaths occurred in the oxprenolol-treated group . Even in this small number of patients these results were considerably better than those in untreated women with hypertension of similar severity . Apgar scores in both groups were equivalent at birth , while blood sugar concentrations were higher in the oxprenolol group . Oxprenolol appears to be safe and effective in controlling hypertension during pregnancy . There was no evidence of harmful effects on the fetus , and oxprenolol may offer a selective advantage over methyldopa for fetal growth and wellbeing in utero"
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PURPOSE To systematic ally review lifestyle interventions for women with prior Gestational Diabetes Mellitus ( GDM ) to report study characteristics , intervention design and study quality and explore changes in 1 ) diet , physical activity and sedentary behaviour ; 2 ) anthropometric outcomes and ; 3 ) glycaemic control and diabetes risk . METHODS Data bases ( Web of Science , CC RCT , EMBASE and Science DIRECT ) were search ed ( 1980 to April 2014 ) using keywords for controlled or pre-post design trials of lifestyle intervention targeting women with previous GDM reporting at least one behavioural , anthropometric or diabetes outcome . Selected studies were narratively synthesized with anthropometric and glycaemic outcomes synthesized using meta- analysis . RESULTS Three of 13 included studies were rated as low bias risk . Recruitment rates were poor but study retention good . Six of 11 studies reporting on physical activity reported favourable intervention effects . All six studies reporting on diet reported favourable intervention effects . In meta- analysis , significant weight-loss was attributable to one Chinese population study ( WMD = - 1.06 kg ( 95 % CI = - 1.68 , - 0.44 ) ) . Lifestyle interventions did not change fasting blood glucose ( WMD = - 0.05 mmol/L , 95 % CI = - 0.21 , 0.11 ) or type 2 diabetes risk . CONCLUSIONS Lack of method ologically robust trials gives limited evidence for the success of lifestyle interventions in women with prior GDM . Recruitment into trials is challenging
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"OBJECTIVE To pilot , among women with gestational diabetes mellitus ( GDM ) , the feasibility of a prenatal/postpartum intervention to modify diet and physical activity similar to the Diabetes Prevention Program . The intervention was delivered by telephone , and support for breastfeeding was addressed . RESEARCH DESIGN AND METHODS The goal was to help women return to their prepregnancy weight , if it was normal , or achieve a 5 % reduction from prepregnancy weight if overweight . Eligible participants were identified shortly after a GDM diagnosis ; 83.8 % consented to be r and omly assigned to intervention or usual medical care ( 96 and 101 women , respectively ) . The retention was 85.2 % at 12 months postpartum . RESULTS The proportion of women who reached the postpartum weight goal was higher , although not statistically significant , in the intervention condition than among usual care ( 37.5 vs. 21.4 % , absolute difference 16.1 % , P = 0.07 ) . The intervention was more effective among women who did not exceed the recommended gestational weight gain ( difference in the proportion of women meeting the weight goals : 22.5 % , P = 0.04 ) . The intervention condition decreased dietary fat intake more than the usual care ( condition difference in the mean change in percent of calories from fat : −3.6 % , P = 0.002 ) and increased breastfeeding , although not significantly ( condition difference in proportion : 15.0 % , P = 0.09 ) . No differences in postpartum physical activity were observed between conditions . CONCLUSIONS This study suggests that a lifestyle intervention that starts during pregnancy and continues postpartum is feasible and may prevent pregnancy weight retention and help overweight women lose weight . Strategies to help postpartum women overcome barriers to increasing physical activity are needed",
"To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results",
"Background Gestational diabetes mellitus ( GDM ) is defined as glucose intolerance with its onset or first recognition during pregnancy . Post-GDM women have a life-time risk exceeding 70 % of developing type 2 diabetes mellitus ( T2DM ) . Lifestyle modifications reduce the incidence of T2DM by up to 58 % for high-risk individuals . Methods / Design The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program ( MAGDA-DPP ) is a r and omized controlled trial aim ing to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women . This trial has an intervention group participating in a diabetes prevention program ( DPP ) , and a control group receiving usual care from their general practitioners during the same time period . The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals , and two follow-up telephone calls . A total of 574 women will be recruited , with 287 in each arm . The women will undergo blood tests , anthropometric measurements , and self-reported health status , diet , physical activity , quality of life , depression , risk perception and healthcare service usage , at baseline and 12 months . At completion , primary outcome ( changes in diabetes risk ) and secondary outcome ( changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors ) will be assessed in both groups . Discussion This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women . The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population .Trial registration Australian New Zeal and Clinical Trials Registry ANZCTRN",
"Background Women with gestational diabetes ( GDM ) are at high risk of developing diabetes later in life . After a GDM diagnosis , women receive prenatal care to control their blood glucose levels via diet , physical activity and medications . Continuing such lifestyle skills into early motherhood may reduce the risk of diabetes in this high risk population . In the Gestational Diabetes ’ Effects on Moms ( GEM ) study , we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management design ed for pregnant/postpartum women with GDM and delivered at the health system level . Methods / Design The GEM study is a pragmatic cluster r and omized clinical trial of 44 medical facilities at Kaiser Permanente Northern California r and omly assigned to either the intervention or usual care conditions , that includes 2,320 women with a GDM diagnosis between March 27 , 2011 and March 30 , 2012 . A Diabetes Prevention Program-derived print/telephone lifestyle intervention of 13 telephonic sessions tailored to pregnant/postpartum women was developed . The effectiveness of this intervention added to usual care is to be compared to usual care practice s alone , which includes two pages of printed lifestyle recommendations sent to postpartum women via mail . Primary outcomes include the proportion of women who reach a postpartum weight goal and total weight change . Secondary outcomes include postpartum glycemia , blood pressure , depression , percent of calories from fat , total caloric intake and physical activity levels . Data were collected through electronic medical records and surveys at baseline ( soon after GDM diagnosis ) , 6 weeks ( range 2 to 11 weeks ) , 6 months ( range 12 to 34 weeks ) and 12 months postpartum ( range 35 to 64 weeks ) . Discussion There is a need for evidence regarding the effectiveness of lifestyle modification for the prevention of diabetes in women with GDM , as well as confirmation that a diabetes prevention program delivered at the health system level is able to successfully reach this population . Given the use of a telephonic case management model , our Diabetes Prevention Program-derived print/telephone intervention has the potential to be adopted in other setting s and to inform policies to promote the prevention of diabetes among women with GDM.Trial registration Clinical Trials.gov number , NCT01344278",
"Background Postnatal women ( are at increased risk of physical inactivity . Purpose To evaluate the efficacy and feasibility of a theory-based physical activity ( PA ) intervention delivered to postnatal women primarily via mobile telephone short message service ( SMS ) . Methods Eighty-eight women were r and omized to the intervention ( n = 45 ) or minimal contact control ( n = 43 ) condition . The 12-week intervention consisted of a face-to-face PA goal - setting consultation , a goal - setting magnet , three to five personally tailored SMS/week and a nominated support person who received two SMS per week . SMS content targeted constructs of social cognitive theory . Frequency ( days/week ) and duration ( min/week ) of PA participation and walking for exercise were assessed via self-report at baseline , 6 and 13 weeks . Results Intervention participants increased PA frequency by 1.82 days/week ( SE ± 0.18 ) by 13 weeks ( F(2,85 ) = 4.46 , p = 0.038 ) and walking for exercise frequency by 1.08 days/week ( SE ± 0.24 ) by 13 weeks ( F(2,85 ) = 5.38 , p = 0.02 ) . Positive trends were observed for duration ( min/week ) of PA and walking for exercise . Conclusions Intervention exposure result ed in increased frequency of PA and walking for exercise in postnatal women",
"Background Gestational Diabetes Mellitus ( GDM ) increases risks for type 2 diabetes and weight management is recommended to reduce the risk . Conventional dietary recommendations ( energy-restricted , low fat ) have limited success in women with previous GDM . The effect of lowering Glycaemic Index ( GI ) in managing glycaemic variables and body weight in women post-GDM is unknown . Objective To evaluate the effects of conventional dietary recommendations administered with and without additional low-GI education , in the management of glucose tolerance and body weight in Asian women with previous GDM . MethodS eventy seven Asian , non-diabetic women with previous GDM , between 20- 40y were r and omised into Conventional healthy dietary recommendation ( CHDR ) and low GI ( LGI ) groups . CHDR received conventional dietary recommendations only ( energy restricted , low in fat and refined sugars , high-fibre ) . LGI group received advice on lowering GI in addition . Fasting and 2-h post-load blood glucose after 75 g oral glucose tolerance test ( 2HPP ) were measured at baseline and 6 months after intervention . Anthropometry and dietary intake were assessed at baseline , three and six months after intervention . The study is registered at the Malaysian National Medical Research Register ( NMRR ) with Research ID : 5183 . Results After 6 months , significant reductions in body weight , BMI and waist-to-hip ratio were observed only in LGI group ( P changes were significantly different between groups ( LGI vs. CHDR : -0.6 vs. 0 kg/m2 , P= 0.03 ) . More subjects achieved weight loss ≥5 % in LGI compared to CHDR group ( 33 % vs. 8 % , P=0.01 ) . Changes in 2HPP were significantly different between groups ( LGI vs. CHDR : median ( IQR ) : -0.2(2.8 ) vs. + 0.8 ( 2.0 ) mmol/L , P=0.025 ) . Subjects with baseline fasting insulin≥2 μIU/ml had greater 2HPP reductions in LGI group compared to those in the CHDR group ( −1.9±0.42 vs. + 1.31±1.4 mmol/L , P showed significantly lower GI ( 57±5 vs. 64±6 , P ) . Caloric intakes were comparable between groups . Conclusion In women post-GDM , lowering GI of healthy diets result ed in significant improvements in glucose tolerance and body weight reduction as compared to conventional low-fat diets with similar energy prescription",
"CONTEXT A past history of gestational diabetes mellitus ( GDM ) confers a very high risk of postpartum development of diabetes , particularly type 2 diabetes . OBJECTIVE The Diabetes Prevention Program ( DPP ) sought to identify individuals with impaired glucose tolerance ( IGT ) and intervene in an effort to prevent or delay their progression to diabetes . This analysis examined the differences between women enrolled in DPP with and without a reported history of GDM . DESIGN The DPP was a r and omized , controlled clinical trial . SETTING The study was a multicenter , National Institutes of Health-sponsored trial carried out at 27 centers including academic and Indian Health Services sites . PATIENTS A total of 2190 women were r and omized into the DPP and provided information for past history of GDM . This analysis addressed the differences between those 350 women providing a past history of GDM and those 1416 women with a previous live birth but no history of GDM . INTERVENTIONS Subjects were r and omized to either st and ard lifestyle and placebo or metformin therapy or to an intensive lifestyle intervention . MAIN OUTCOMES The primary outcome was the time to development of diabetes ascertained by semiannual fasting plasma glucose and annual oral glucose tolerance testing . Assessment s of insulin secretion and insulin sensitivity were also performed . RESULTS Whereas entering the study with similar glucose levels , women with a history of GDM r and omized to placebo had a crude incidence rate of diabetes 71 % higher than that of women without such a history . Among women reporting a history of GDM , both intensive lifestyle and metformin therapy reduced the incidence of diabetes by approximately 50 % compared with the placebo group , whereas this reduction was 49 and 14 % , respectively in parous women without GDM . These data suggest that metformin may be more effective in women with a GDM history as compared with those without . CONCLUSIONS Progression to diabetes is more common in women with a history of GDM compared with those without GDM history despite equivalent degrees of IGT at baseline . Both intensive lifestyle and metformin are highly effective in delaying or preventing diabetes in women with IGT and a history of GDM",
"Optimal strategies to prevent progression towards overt diabetes in women with recent gestational diabetes remain ill defined . We report a pilot study of a convenient , home based exercise program with telephone support , suited to the early post-partum period . Twenty eight women with recent gestational diabetes were enrolled at six weeks post-partum into a 12 week r and omised controlled trial of Usual Care ( n = 13 ) versus Supported Care ( individualised exercise program with regular telephone support ; n = 15 ) . Baseline characteristics ( Mean ± SD ) were : Age 33 ± 4 years ; Weight 80 ± 20 kg and Body Mass Index ( BMI ) 30.0 ± 9.7 kg/m2 . The primary outcome , planned physical activity { Median ( Range ) } , increased by 60 ( 0–540 ) mins/week in the SC group versus 0 ( 0–580 ) mins/week in the UC group ( P = 0.234 ) . Walking was the predominant physical activity . Body weight , BMI , waist circumference , % body fat , fasting glucose and insulin did not change significantly over time in either group . This intervention design ed to increase physical activity in post-partum women with previous gestational diabetes proved feasible . However , no measurable improvement in metabolic or biometric parameters was observed over a three month period",
"AIMS Women with remote histories of gestational diabetes mellitus can reduce their diabetes risk through lifestyle changes , but the effectiveness of interventions in women with more recent histories of gestational diabetes has not been reported . Therefore , we conducted a pilot study of a low-intensity web-based pedometer programme targeting glucose intolerance among women with recent gestational diabetes . METHODS Women with a gestational diabetes delivery within the past 3 years were r and omized to a 13-week intervention consisting of a structured web-based pedometer programme which gave personalized steps-per-week goals , pedometers and education regarding lifestyle modification , or to a letter about diabetes risk reduction and screening after delivery for gestational diabetes ( control condition ) . The main outcome measures were change in fasting plasma glucose and 2-h glucose levels on a 75-g oral glucose tolerance test between baseline and 13-week follow-up . Weight was a secondary outcome and behavioural constructs ( self-efficacy , social support , risk perception ) were also assessed . RESULTS Forty-nine women were enrolled . At 13-week follow-up , women r and omized to the intervention did not have significant changes in behavioural constructs , physical activity or anthropometrics compared with women in the control group . Changes in fasting plasma glucose ( -0.046 mmol/l vs. 0.038 mmol/l , P = 0.65 ) , 2-h glucose values ( -0.48 mmol/l vs. -0.42 mmol/l , P = 0.91 ) and weight ( -0.14 kg vs. -1.5 kg , P = 0.13 ) were similar between the control and intervention groups , respectively . CONCLUSIONS Structured web-based education utilizing pedometers is feasible although uptake may be low . Such programmes may need to be supplemented with additional measures in order to be effective for reduction of diabetes risk",
"IMPORTANCE Women with a history of gestational diabetes mellitus ( GDM ) are at substantially increased risk of type 2 diabetes mellitus ( T2DM ) . The identification of important modifiable factors could help prevent T2DM in this high-risk population . OBJECTIVE To examine the role of physical activity and television watching and other sedentary behaviors , and changes in these behaviors in the progression from GDM to T2DM . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 4554 women from the Nurses ' Health Study II who had a history of GDM , as part of the ongoing Diabetes & Women 's Health Study . These women were followed up from 1991 to 2007 . EXPOSURES Physical activity and television watching and other sedentary behaviors were assessed in 1991 , 1997 , 2001 , and 2005 . MAIN OUTCOMES AND MEASURE Incident T2DM identified through self-report and confirmed by supplemental question naires . RESULTS We documented 635 incident T2DM cases during 59,287 person-years of follow-up . Each 5-metabolic equivalent hours per week ( MET-h/wk ) increment of total physical activity , which is equivalent to 100 minutes per week of moderate-intensity physical activity , was related to a 9 % lower risk of T2DM ( adjusted relative risk [ RR ] , 0.91 ; 95 % CI , 0.88 - 0.94 ) ; this inverse association remained significant after additional adjustment for body mass index ( BMI ) . Moreover , an increase in physical activity was associated with a lower risk of developing T2DM . Compared with women who maintained their total physical activity levels , women who increased their total physical activity levels by 7.5 MET-h/wk or more ( equivalent to 150 minutes per week of moderate-intensity physical activity ) had a 47 % lower risk of T2DM ( RR , 0.53 ; 95 % CI , 0.38 - 0.75 ) ; the association remained significant after additional adjustment for BMI . The multivariable adjusted RRs ( 95 % CIs ) for T2DM associated with television watching of 0 to 5 , 6 to 10 , 11 to 20 , and 20 or more hours per week were 1 ( reference ) , 1.28 ( 1.04 - 1.59 ) , 1.41 ( 1.11 - 1.79 ) , and 1.77 ( 1.28 - 2.45 ) , respectively ( P value for trend T2DM . These findings suggest a hopeful message to women with a history of GDM , although they are at exceptionally high risk for T2DM , promoting an active lifestyle may lower the risk",
"BACKGROUND Women with children are less likely to engage in adequate physical activity ( PA ) than women without children . This study aim ed to evaluate the efficacy of two strategies for promoting increased PA among mothers of preschool-aged children , and to explore the mediators of any result ing change in PA behavior . DESIGN Controlled intervention trial incorporating repeated data collection from 554 women , r and omized to one of three experimental conditions . Intervention Group 1 served as a control , while women in Groups 2 and 3 were given print information about overcoming PA barriers . Women in Group 3 were also invited to discuss the development of local strategies for the promotion of PA among mothers of young children . The primary strategies included increasing partner support , social advocacy , and capacity building , and were implemented through collaboration among participants , research ers , and community organizations . MAIN OUTCOME MEASURES Adequate physical activity ( PA ) , self-efficacy ( SE ) and partner support ( PS ) . RESULTS Following the intervention , women in Group 3 were significantly more likely to meet guidelines for PA than controls ( odds ratio [OR]=1.71 , confidence interval [CI]=1.05 - 2.77 ) ] after controlling for age and PA at baseline . After controlling for baseline PA , residualized change in SE ( OR=1.86 , CI=1.17 - 2.94 ) and PS ( OR=2.29 , CI=1.46 - 3.58 ) significantly predicted meeting guidelines . After controlling for residual change in PS and SE , the significant intervention effect was attenuated ( Group 3 OR=1.40 , CI=0.76 - 2.36 ) , indicating that partner support and self-efficacy may be mediators of physical activity behavior change . CONCLUSIONS The findings indicate that community participation approaches that facilitate increased self-efficacy and partner support can be effective in increasing PA among mothers of young children",
"BACKGROUND In the 2.8 years of the Diabetes Prevention Program ( DPP ) r and omised clinical trial , diabetes incidence in high-risk adults was reduced by 58 % with intensive lifestyle intervention and by 31 % with metformin , compared with placebo . We investigated the persistence of these effects in the long term . METHODS All active DPP participants were eligible for continued follow-up . 2766 of 3150 ( 88 % ) enrolled for a median additional follow-up of 5.7 years ( IQR 5.5 - 5.8 ) . 910 participants were from the lifestyle , 924 from the metformin , and 932 were from the original placebo groups . On the basis of the benefits from the intensive lifestyle intervention in the DPP , all three groups were offered group-implemented lifestyle intervention . Metformin treatment was continued in the original metformin group ( 850 mg twice daily as tolerated ) , with participants unmasked to assignment , and the original lifestyle intervention group was offered additional lifestyle support . The primary outcome was development of diabetes according to American Diabetes Association criteria . Analysis was by intention-to-treat . This study is registered with Clinical Trials.gov , number NCT00038727 . FINDINGS During the 10.0-year ( IQR 9.0 - 10.5 ) follow-up since r and omisation to DPP , the original lifestyle group lost , then partly regained weight . The modest weight loss with metformin was maintained . Diabetes incidence rates during the DPP were 4.8 cases per 100 person-years ( 95 % CI 4.1 - 5.7 ) in the intensive lifestyle intervention group , 7.8 ( 6.8 - 8.8 ) in the metformin group , and 11.0 ( 9.8 - 12.3 ) in the placebo group . Diabetes incidence rates in this follow-up study were similar between treatment groups : 5.9 per 100 person-years ( 5.1 - 6.8 ) for lifestyle , 4.9 ( 4.2 - 5.7 ) for metformin , and 5.6 ( 4.8 - 6.5 ) for placebo . Diabetes incidence in the 10 years since DPP r and omisation was reduced by 34 % ( 24 - 42 ) in the lifestyle group and 18 % ( 7 - 28 ) in the metformin group compared with placebo . INTERPRETATION During follow-up after DPP , incidences in the former placebo and metformin groups fell to equal those in the former lifestyle group , but the cumulative incidence of diabetes remained lowest in the lifestyle group . Prevention or delay of diabetes with lifestyle intervention or metformin can persist for at least 10 years . FUNDING National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK )",
"Background Women who are diagnosed with gestational diabetes mellitus ( GDM ) are at increased risk for developing prediabetes and type 2 diabetes mellitus ( T2DM ) . To date , there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM . This paper describes the rationale , design and methodology of a 2-year , r and omized , controlled study being conducted in North Carolina . Methods / Design Using a two-group , repeated measures , experimental design , we will test a 14- week intensive intervention on the benefits of breastfeeding , underst and ing gestational diabetes and risk of progression to prediabetes and T2DM , nutrition and exercise education , coping skills training , physical activity ( Phase I ) , educational and motivational text messaging and 3 months of continued monthly contact ( Phase II ) . A total of 100 African American , non-Hispanic white , and bilingual Hispanic women between 22–36 weeks of pregnancy who are diagnosed with GDM and their infants will be r and omized to either the experimental group or the wait-listed control group . The first aim of the study is to determine the feasibility of the intervention . The second aim of study is to test the effects of the intervention on maternal outcomes from baseline ( 22–36 weeks pregnant ) to 10 months postpartum . Primary maternal outcomes will include fasting blood glucose and weight ( BMI ) from baseline to 10 months postpartum . Secondary maternal outcomes will include clinical , adiposity , health behaviors and self-efficacy outcomes from baseline to 10 months postpartum . The third aim of the study is to quantify the effects of the intervention on infant feeding and growth . Infant outcomes will include weight status and breastfeeding from birth through 10 months of age . Data analysis will include general linear mixed-effects models . Safety endpoints include adverse event reporting . Discussion Findings from this trial may lead to an effective intervention to assist women diagnosed with GDM to improve maternal glucose homeostasis and weight as well as stabilize infant growth trajectory , reducing the burden of metabolic disease across two generations . Trial registration",
"OBJECTIVE To assess whether lifestyle intervention can reduce type 2 diabetes risk in women with prior GDM in the Tianjin Gestational Diabetes Mellitus ( GDM ) Prevention Program . METHODS 1180 women who were diagnosed with GDM from 2005 to 2009 were r and omly assigned to either a lifestyle intervention ( n=586 ) or a control group ( n=594 ) . Major elements of the intervention include six face-to-face meetings with study dietitians in the first year , and two additional sessions and two telephone calls in second year . RESULTS During the first year , average body weight loss in the first 404 subjects was 1.40 kg ( 2.1 % ) in the intervention group vs 0.21 kg ( 0.3 % ) in the control group ( P=0.001 ) , and the decrease was more significant among baseline overweight women ( body bass index [ BMI ] ≥24 kg/m² ) in the intervention ( 2.91 kg/4.2 % ) compared with that in the control group ( 0.51 kg/0.7 % ) ( P have decreased BMI , body fat , waist circumference , and plasma insulin levels , and have improved behaviors including increased leisure time activity and dietary fiber intake and decreased sedentary time and fat consumptions . CONCLUSION The interim results support the efficacy and feasibility of the lifestyle intervention program",
"Summary : Women with impaired glucose tolerance are at high risk of developing noninsulin dependent diabetes mellitus ( NIDDM ) . The Mercy Hospital for Women has a long‐term follow‐up programme for women with gestational diabetes , which identifies many women with impaired glucose tolerance . Two hundred of these women were entered into a r and omized controlled trial of intensive versus routine dietary advice . Seven women were lost to follow‐up . The annual incidence rates of diabetes mellitus for the 2 groups were 6.1 % ( intervention ) and 7.3 % ( control ) , an incident rate ratio of 0.83 , 95 % confidence interval 0.47–1.48 , p = 0.50 . Overall , there was a return to normal glucose tolerance in 44 % of patients . Multivariate analysis showed that body mass index , fasting and 2‐hour plasma glucose levels at trial entry were significantly associated with an increased risk of diabetes mellitus . Impaired glucose tolerance is an important condition that should be treated with advice about lifestyle modification ( diet and /or exercise ) . We consider that future trials in the management of women with previous gestational diabetes who have impaired glucose tolerance should investigate the effect of pharmacological intervention in addition to diet and /or exercise , the latter providing a therapy that it would be unethical to exclude on the evidence presently available",
" Forty-three women were recruited into a 1-year r and omised controlled trial to test the feasibility of a structured behavioural intervention to increase physical activity after gestational diabetes . Increases in achievement of physical activity targets were not attained . Recruitment and subject retention were identified as major challenges"
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BACKGROUND : Enhanced surgical recovery protocol s are design ed to reduce hospital length of stay and health care costs . OBJECTIVE : This study aims to systematic ally review and summarize evidence from r and omized and controlled clinical trials comparing enhanced recovery protocol s versus usual care in adults undergoing elective colorectal surgery with emphasis on recent trials , protocol components , and subgroups for surgical approach and colorectal condition . DATA SOURCES : MEDLINE from 2011 to July 2017 ; reference lists of existing systematic review s and included studies were review ed to identify all eligible trials published before 2011 . STUDY SELECTION : English language trials comparing a protocol of preadmission , preoperative , intraoperative , and postoperative components with usual care in adults undergoing elective colorectal surgery were selected . INTERVENTION : The enhanced recovery protocol for colorectal surgery was investigated . MAIN OUTCOME MEASURES : Length of stay , perioperative morbidity , mortality , readmission within 30 days , and surgical site infection were the primary outcomes measured . RESULTS : Twenty-five trials of open or laparoscopic surgery for cancer or noncancer conditions were included . Enhanced recovery protocol s consisted of 4 to 18 components . Few studies fully described the various components . Length of stay ( mean reduction , 2.6 days ; 95 % CI , –3.2 to –2.0 ) and risk of overall perioperative morbidity ( risk ratio , 0.66 ; 95 % CI , 0.54–0.80 ) were lower in enhanced recovery protocol groups than in usual care groups ( moderate- quality evidence ) . All-cause mortality ( rare ) , readmissions , and surgical site infection rates were similar between protocol groups ( low- quality evidence ) . In predefined subgroup analyses , findings did not vary by surgical approach ( open vs laparoscopic ) or colorectal condition . LIMITATIONS : Protocol s varied across studies and little information was provided regarding compliance with , or implementation of , specific protocol components . CONCLUSIONS : Enhanced recovery protocol s for adults undergoing colorectal surgery improve patient outcomes with no increase in adverse events . Evidence was insufficient regarding which components , or component combinations , are key to improving patient outcomes . PROSPERO registration number : CRD42017067991
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"AIM Fast track protocol ( FTP ) showed to improve perioperative care . The study aims to evaluate the impact of the FTP in the open extraperitoneal rectal cancer ( ERC ) surgical treatment without a primary derivative stoma ( DS ) and the QoL in patients with or without a secondary DS . PATIENTS AND METHODS 50 patients affected by ERC were enrolled and operated on with open low anterior resection without a primary DS . They were r and omized in two groups : one was treated perioperativelly in the traditional way ( group T ) , the other using a modif ed FTP ( group FT ) . A QoL question naire was administered prior to discharge and at 1-month follow-up . RESULTS Five courses ( 10 % ) were complicated by anastomotic leakage : 3 ( 12 % ) in the FT group ( 2 minor and 1 maior ) and 2 ( 8 % ) in the T group ( 1 minor and 1 maior ) ( p = n.s . ) . All the maiors and one minor were treated with a DS . Patients of the group FTP were considered dischargeable earlier that those of group T ( p Patients with DS had a significantly lower QoL score ( p FTP with minor modifications is feasible and safe in the ERC open surgery without using a DS . Better results were obtained without increasing complication rate . A secondary DS impacts detrimentally on",
" The aim of this r and omized clinical trial was to compare patients treated using a multimodal approach [ enhanced recovery after surgery ( ERAS ) ] , with a special focus on counselling , to patients treated in a st and ard conventional care pathway , who underwent elective colorectal resection",
"BACKGROUND / AIMS Fast track ( IT ) rehabilitation programmes have demonstrated advantages over traditional perioperative care after open colonic surgery ; however . their contribution in recovery after laparoscopic colonic surgery is not clearly defined . This study was conducted to estimate the value of FT rehabilitation programme in laparoscopic colonic resections . METHODOLOGY This is a r and omized prospect i ve controlled clinical trial . Ninety-nine consecutive patients underwent elective laparoscopic colonic resection between February 2008 and March 2009 . Forty-nine patients received FT multimodal rehabilitation programme as FT group and 50 patients underwent traditional perioperative care as non-FT group . Postoperative hospital stay , return of gastrointestinal function , postoperative complications were recorded . RESULTS Postoperative hospital stay was shorter in the FT group , a median duration of 4.0 days versus 5.0 days in the non-FT group ( p Gastrointestinal functional recovery occurred 1 day earlier in FT group ( passage of flatus after 2.0 days vs. 3.0 days , p significant differences in complications within 30 postoperative days ( 12 % in FT group vs. 20 % in non-FT group , p=0.295 ) . CONCLUSIONS When applied after laparoscopic colonic surgery , FT rehabilitation programme is feasible , safe and may lead to accelerated functional recovery and reductions in postoperative hospital stay",
"BACKGROUND Studies have shown the value of using fast-track postoperative recovery . St and ard procedures ( non-fast-track strategies ) remain in common use for perioperative care . Few prospect i ve reports exist on the outcome of fast-tracking in Central Europe . The aim of our study was to assess the effect and safety of our own fast-track protocol with regard to the postoperative period after open bowel resection . PATIENTS AND METHODS One hundred and five patients with ASA score I-II scheduled for open intestinal resection in the period April 2005-December 2007 were r and omly selected for the fast-track group ( FT ) and non-fast-track group ( non-FT ) . A design ed protocol was used in the FT group with the emphasis on an interdisciplinary approach . The control group ( non-FT ) was treated by st and ard established procedures . Postoperative pain , rehabilitation , gastrointestinal functions , postoperative complications , and post-op length of stay were recorded . RESULTS Of 105 patients , 103 were statistically analyzed . Patients in the FT group ( n=51 ) and non-FT group ( n=52 ) did not differ in age , surgical diagnosis , or procedure . The fast-track procedure led to significantly better control of postoperative pain and faster restoration of GI functions ( bowel movement after 1.3 days vs. 3.1 , p Food tolerance was significantly better in the FT group and rehabilitation was also faster . Hospital stay was shorter in the FT group - median seven days ( 95 % CI 7.0 - 7.7 ) versus ten days ( 95 % CI 9.5 - 11.3 ) in non-FT ( p Postoperative complications within 30 postoperative days were also significantly lower in the FT group ( 21.6 vs. 48.1 % , p=0.003 ) . There were no deaths and no patients were readmitted within 30 days . CONCLUSIONS Following the FT protocol helped to reduce frequency of postoperative complications and reduced hospital stay . We conclude that the FT strategy is safe and effective in improving postoperative outcomes",
"STUDY OBJECTIVE To study the application of a fast-track care protocol in colorectal surgery for deep infiltrating endometriosis . Bowel endometriosis is an infrequent but not rare condition that often needs intestinal surgery and imposes a high economic burden on society . DESIGN Prospect i ve r and omized trial ( Canadian Task Force classification I ) . SETTING Tertiary referral center . PATIENTS Two hundred twenty-seven patients with preoperative evidence of bowel endometriosis . INTERVENTIONS We r and omly assigned 227 patients with preoperative evidence of bowel endometriosis to a fast-track protocol ( no preoperative bowel preparation , early restoration of diet , no postoperative antibiotics , and early postoperative mobilization ) or conventional care for laparoscopic intestinal surgery . R and omization was obtained on a double-blind , date -based schedule , and all procedures were performed by a homogenous group of expert surgeons . Surgical outcomes and a health economic evaluation were assessed . MEASUREMENTS AND MAIN RESULTS The primary outcome was hospital stay . Patient 's well-being and intraoperative and postoperative complications up to 30 days after surgery were also assessed . Subsequently , direct medical costs were analyzed . Patients assigned to the fast-track protocol were discharged earlier ( median 3 vs 7 days , p subjective well-being ( p = .55 ) . Operative details , postoperative complications , and need of temporary ileostomy were similar ( p = .89 ) between groups as well as readmission rates within 30 days ( p = .69 ) . The application of a fast-track protocol result ed in an overall significant reduction of costs ( USD 6699 vs 8674 , p fast-track care protocol for laparoscopy in cases of pelvic and intestinal endometriosis does not increase the risk of complications and ensures a reduction of medical costs",
"Objective Enhanced recovery after surgery ( ERAS ) integrates evidence -based interventions to reduce surgical stress and accelerate rehabilitation . Our study was to compare the short-term quality of life ( QOL ) in patients undergoing open colonic surgery using ERAS program or conventional management . Methods A prospect i ve study of 57 patients using ERAS program and 60 patients using conventional management was conducted . The clinical characteristics of all patients were recorded . QOL was evaluated longitudinally using the question naires ( EORTC QLQ-C30 and QLQ-CR29 ) pre- and postoperatively . Generalized estimating equation was used to do the analysis in order to determine the effective impact of correlative factors on the postoperative QOL , including age , sex , BMI , ASA grade , tumor location , tumor size , pTNM stage , recovery program and length of time after surgery . Results The morbidity in ERAS and control group was 17.5 versus 26.7 % ( p = 0.235 ) . The patients in ERAS group had much faster rehabilitation and less hospital stay . In the primary statistical analysis , the scores of global QOL ( on POD3 , POD6 , POD10 , POD14 , POD21 ) , physical functioning ( on POD3 , POD6 , POD10 , POD14 , POD21 ) , role functioning ( on POD6 , POD10 , POD14 , POD21 ) , emotional functioning ( on POD3 , POD6 , POD10 , POD14 , POD21 ) , cognitive functioning ( on POD3 , POD6 ) and social functioning ( on POD3 , POD6 , POD10 , POD14 , POD21 , POD28 ) were higher in ERAS group than in control group , which suggested that the patients in ERAS group had a better life status . However , the scores of pain ( on POD10 , POD14 , POD21 ) , appetite loss ( on POD3 , POD6 ) , constipation ( on POD3 , POD6 , POD10 ) , diarrhea ( on POD3 , POD10 ) , financial difficulties ( on POD10 , POD14 , POD21 ) , perspective of future health ( on POD6 , POD10 , POD14 ) , gastrointestinal tract problems ( on POD3 , POD6 , POD10 ) and defecation problems ( on POD6 , POD10 , POD14 ) were lower in ERAS group than in control group , which revealed that the patients in ERAS group suffered less symptoms . In the further generalized estimating equation analysis , the result showed that recovery program and length of time after surgery had independently positive impact on the patient ’s postoperative QOL . ConclusionS hort-term QOL in patients undergoing colonic cancer using ERAS program was better than that using conventional management",
"The value of fast-track ( FT ) multimodal recovery programs in improving hospitalization of surgical patients has been widely proved . The application of FT protocol s to laparoscopic colorectal surgery seems to maximize the effects of the minimally invasive approach . The objectives of this r and omized-controlled trial are to compare the short-term outcomes ( bowel function , return to oral nutrition , day of discharge , fatigue , time to resume normal activities , functional capabilities , and readmission rate ) of patients undergoing elective laparoscopic high anterior resection ( HAR ) following either a FT or a st and ard program . The prospect i ve r and omized-controlled trial included 52 consecutive patients undergoing elective laparoscopic HAR . Group 1 was treated with a FT rehabilitation program , and group 2 was treated with a st and ard care ( SC ) program . Patients were interviewed 14 and 30 days postoperatively . One patient in each group was excluded from the study . Mean hospital stay , time of first bowel movement , and bowel function resumption were significantly shorter in the FT group ( P pain in day 0 versus patients in the SC group ( P Fatigue was significantly reduced at day 14 in the FT group compared with the SC group ( P ability to resume the normal preoperative attitude ( walking stairs , cooking , housekeeping , shopping , and walking outdoors ) was significantly better at day 14 in the FT group ( P no significant difference between the 2 groups at day 30 for the same parameters . There were no readmissions in both the groups and no need for consultations from general practitioners . FT multimodal program is a safe approach effective on postoperative short-term outcome significantly reducing hospital stay . Early postoperative pain control needs to be optimized",
"Purpose The aim of this multi-institutional study was to prospect ively evaluate the safety and efficacy of an enhanced recovery after surgery ( ERAS ) protocol for colonic surgery . Methods The subjects of this study were 320 patients with an American Society of Anesthesiologists ( ASA ) grade I or II physical status . Patients underwent elective open or laparoscopic colonic resection or high anterior resection between April 2011 and January 2014 at one of six institutions . Three hospitals implemented an ERAS protocol ( n = 159 ) , and three administered conventional care ( n = 161 ) . The primary outcome measure was the surgical complication rate . Results Most operations , irrespective of group , were performed laparoscopically . The incidence of a surgical complication was 17.0 % in the ERAS group vs. 16.1 % in the conventional group ( P = 0.842 ) , in which several non-surgical complications also arose . Oral food intake was implemented earlier for the ERAS group vs. the conventional group , after a median ( range ) of 1 ( 1–31 ) vs. 3 ( 1–9 ) days for the ERAS vs. conventional care groups , respectively ( P 0.001 ) . The median length of postoperative hospital stay was reduced by 5.5 days for the ERAS group , being 8.5 ( 5–41 ) vs. 14 ( 7–56 ) days for the ERAS vs. conventional care groups , respectively ( P efficient , without increasing the complication risk ",
"Objective This study aims to investigate the role of fast-track surgery in preventing the development of postoperative delirium and other complications in elderly patients with colorectal carcinoma . Methods A total of 240 elderly patients with colorectal carcinoma ( aged ≥70 years ) undergoing open colorectal surgery was r and omly assigned into two groups , in which the patients were managed perioperatively either with traditional or fast-track approaches . The length of hospital stay ( LOS ) and time to pass flatus were compared . The incidence of postoperative delirium and other complications were evaluated . Serum interleukin-6 ( IL-6 ) levels were determined before and after surgery . Results The LOS was significantly shorter in the fast-track surgery ( FTS ) group than that in the traditional group . The recovery of bowel movement ( as indicated by the time to pass flatus ) was faster in the FTS group . The postoperative complications including pulmonary infection , urinary infection and heart failure were significantly less frequent in the FTS group . Notably , the incidence of postoperative delirium was significantly lower in patients with the fast track therapy ( 4/117 , 3.4 % ) than with the traditional therapy ( 15/116 , 12.9 % ; p = 0.008 ) . The serum IL-6 levels on postoperative days 1 , 2 , and 3 in patients with the fast-track therapy were significantly lower than those with the traditional therapy ( p , fast-track surgery decreases the LOS , facilitates the recovery of bowel movement , and reduces occurrence of postoperative delirium and other complications in elderly patients with colorectal carcinoma . The lower incidence of delirium is at least partly attributable to the reduced systemic inflammatory response mediated by IL-6",
"The aim of this trial was to compare multimodal optimization with conventional perioperative management in a consecutive series of patients undergoing a wide range of colorectal procedures",
"Background Fast-track protocol s are followed by an enhanced recovery , early return to bowel function and to complete nutrition , and a reduced hospital stay . Our study was design ed to implement fast-track protocol in our university hospital . Methods The 96 consecutive patients with colorectal neoplasm included in the study were r and omized in two equal groups : group 1 ( FT ) included patients undergoing colorectal surgery in a fast-track protocol , and group 2 ( C ) included patients undergoing colorectal surgery with a conventional care protocol . As with other fast-track protocol s , our protocol included carbohydrate fluids load before operation , early mobilization and oral feeding , regular prokinetics , and multimodal postoperative analgesia . Time to restoration of bowel function , to complete mobilization and feeding , length of hospital stay , and incidence of complications and readmissions were monitored . Results Time to mobilization , restoring of bowel function , and complete oral feeding were significantly shorter with fast-track protocol ( p = 0.001 , p = 0.042 , and p = 0.01 , respectively ) . Hospital stay also was shorter in the fast-track group ( p = 0.001 ) . The incidence of complications did not significantly differ with the study groups . Conclusions In our study , fast-track protocol result ed in a shorter time to mobilization , complete feeding , and discharge from hospital . Fast-track protocol did not increase the incidence of complications . However , we consider that our data require further confirmation with powered multicenter national studies",
"INTRODUCTION Colorectal surgery has been associated with a complication rate of 15 - 20 % and mean post-operative inpatient stays of 6 - 11 days . The principles of enhanced recovery after surgery ( ERAS ) are well established and have been developed to optimise peri-operative care and facilitate discharge . The purpose of this systematic review is to present an up date d review of peri-operative care in colorectal surgery from the available evidence and ERAS group recommendations . METHODS Systematic search es of the PubMed and Embase ™ data bases and the Cochrane library were conducted . A h and search of bibliographies of identified studies was conducted to identify any additional articles missed by the initial search strategy . RESULTS A total of 59 relevant studies were identified . These included six r and omised controlled trials and seven clinical controlled trials that fulfilled the inclusion criteria . These studies showed reductions in duration of inpatient stays in the ERAS groups compared with more traditional care as well as reductions in morbidity and mortality rates . CONCLUSIONS Review ing the data reveals that ERAS protocol s have a role in reducing post-operative morbidity and result in an accelerated recovery following colorectal surgery . Similarly , both primary and overall hospital stays are reduced significantly . However , the available evidence suggests that ERAS protocol s do not reduce hospital readmissions or mortality . These findings help to confirm that ERAS protocol s should now be implemented as the st and ard approach for peri-operative care in colorectal surgery",
"Background Few clinical studies or r and omized clinical trial results have reported the impact of fast-track surgery on human immunity . This study aim ed to investigate the clinical and immune impact of fast-track surgery in colorectal cancer patients undergoing elective open surgery . Methods A controlled r and omized clinical trial was conducted from November 2008 to January 2009 with a 1-month postdischarge follow-up . A total of 70 patients with colorectal carcinoma requiring colorectal resection were r and omized into two groups : a fast-track group ( 35 cases ) and a conventional care group ( 35 cases ) . All included patients underwent elective open colorectal resection with combined tracheal intubation and general anesthesia . Clinical parameters and markers of immune function were evaluated in both groups postoperatively . Results In all , 62 patients completed the study : 32 in the fast-track group and 30 in the conventional care group . Our findings revealed a significantly shorter postoperative hospital stay and faster return of gastrointestinal function in patients undergoing fast-track rehabilitation . In addition , we found a quicker response of white blood cells in the fast-track group than in the conventional care group . We also found that blood levels of globulin , immunoglobulin G , and complement 4 on postoperative day 3 were higher in the fast-track group than in the conventional care group . Conclusions Fast-track surgery accelerates clinical recovery and improves postoperative immunity after elective open surgery for colorectal carcinoma",
"Objective It has been demonstrated that colon operation combined with fast-track ( FT ) surgery and laparoscopic technique can shorten the length of hospital stay , accelerate recovery of intestinal function , and reduce the occurrence of post-operative complications . However , there are no reports regarding the combined effects of FT colon operation and laparoscopic technique on humoral inflammatory cellular immunity . Methods This was a prospect i ve , controlled study . One hundred sixty-three colon cancer patients underwent the traditional protocol and open operation ( traditional open group , n = 42 ) , the traditional protocol and laparoscopic operation ( traditional laparoscopic group , n = 40 ) , the FT protocol and open operation ( FT open group , n = 41 ) , or the FT protocol and laparoscopic operation ( FT laparoscopic group , n = 40 ) . Blood sample s were taken prior to operation as well as on days 1 , 3 , and 5 after operation . The number of lymphocyte sub population s was determined by flow cytometry , and serum interleukin-6 and C-reactive protein levels were measured . Post-operative hospital stay , post-operative morbidity , readmission rate , and in-hospital mortality were recorded . Results Compared with open operation , laparoscopic colon operation effectively inhibited the release of post-operative inflammatory factors and yielded good protection via post-operative cell immunity . FT surgery had a better protective role with respect to the post-operative immune system compared with traditional peri-operative care . Inflammatory reactions , based on interleukin-6 and C-reactive protein levels , were less intense following FT laparoscopic operation compared to FT open operation ; however , there were no differences in specific immunity ( CD3 + and CD4 + counts , and the CD4+/CD8 + ratio ) during these two types of surgical procedures . Post-operative hospital stay in patients r and omized to the FT laparoscopic group was significantly shorter than in the other three treatment groups ( P Post-operative complications in patients who underwent FT laparoscopic treatment were less than in the other three treatment groups ( P readmission rate and in-hospital mortality . Conclusions The laparoscopic technique and FT surgery rehabilitation program effectively inhibited release of post-operative inflammatory factors with a reduction in peri-operative trauma and stress , which together played a protective role on the post-operative immune system . Combining two treatment measures during colon operation produced better protective effects via the immune system . The beneficial clinical effects support that the better-preserved post-operative immune system may also contribute to the improvement of post-operative results in FT laparoscopic patients ",
"Objective The objective of this study is to explore the effects of the fast-track surgery ( FTS ) program on inflammation and immunity in patients undergoing colorectal surgery . Methods From August 2014 to March 2015 , a prospect i ve and r and omized controlled trial of 230 patients who underwent colorectal surgery was performed . The patients were r and omly assigned to an FTS group ( 116 patients ) or a traditional group ( 114 patients ) . Inflammatory mediators , immunological indicators , postoperative recovery indexes , and complications were compared between the two groups . Results The inflammatory mediators ( CRP , IL-6 , TNF-α ) were lower in the FTS group than in the traditional group ( P the immunological indicators ( IgG , IgA , C3 , C4 ) of the FTS group were superior to those of the traditional group ( P The time to first aerofluxus , defecation , oral intake , and ambulation after surgery was shorter in the FTS group than in the traditional group ( P the duration of postoperative hospitalization did not differ significantly between the two groups ( P > 0.05 ) . The total complications were significantly lower in the FTS group than in the traditional group ( P Conclusion The FTS program can decrease inflammation , maintain immune homeostasis , and improve rehabilitation effects in colorectal surgery patients",
"Introduction A ‘ fast-track protocol ’ in surgery suggests the application of evidence -based practice s to expedite patient recovery . It has shown to reduce hospital stay , hasten recovery as well as facilitate earlier return to work . It has a considerable impact in reducing healthcare costs . The basic tenet is to treat the patient ’s disease by minimal disturbance of their physiology . The protocol encompasses pre-operative , intra-operative and post-operative interventions which when carried out together would show maximal benefits . The surgeon is usually the leader of the team managing the patient , but it can not be over-emphasised that this is a multi-disciplinary team approach . Material s and Methods We conducted a prospect i ve interventional study to investigate whether ‘ fast-track ’ surgery protocol s improve patient outcome when compared to traditional peri-operative care followed at our institute . By doing so , we observed that the patients who underwent ‘ fast tracking ’ required lesser analgesia , had earlier ambulation , earlier return of intestinal motility , were free from tubes , catheters and drains earlier and lastly were discharged earlier . This was achieved without a rise in complications or re-admissions . Results / Conclusion The results have proved that implementing the fast-track protocol for gastrointestinal surgeries is not only safe and effective , but also improves patient outcome",
"Background The aim of this trial was to compare the Enhanced Recovery After Surgery ( ERAS ) program with conventional perioperative management in patients who underwent radical resection for colorectal cancer . Methods A combination of evidence -based and consensus methodology was used to develop the ERAS protocol . Five hundred ninety-seven consecutive patients who underwent elective colorectal resection were r and omized to either the ERAS ( n = 299 ) or the control group ( n = 298 ) . Outcomes relating to nutrition and metabolism index , stress index , and recovery index were measured and recorded . Results Demographic and operative data were similar between the two groups . Patients in the ERAS group showed improved nutritional status when compared with those of the control group . On postoperative day ( POD ) 1 , the HOMA-IR ( insulin resistance index ) of the ERAS group was lower than that of the control group ( p The cortisol level of the control group was elevated on both POD 1 ( p = 0.007 ) and POD 5 ( p = 0.002 ) compared to the preoperative level . However , the cortisol level of the ERAS group was not increased until POD 5 ( p = 0.001 ) . Reduced levels of TNF-α , IL-1β , IL-6 , and IFN-γ in the ERAS group indicated less postoperative stress responses . In addition , ERAS was associated with accelerated recovery of gastrointestinal function . The postoperative length of stay ( p ERAS protocol attenuates the surgical stress response and accelerates postoperative recovery without compromising patient safety",
" Multimodal optimization of surgical care has been associated with reduced hospital stay and improved physical function . The aim of this r and omized trial was to compare multimodal optimization with st and ard care in patients undergoing colonic resection",
"Objective : To investigate which perioperative treatment , ie , laparoscopic or open surgery combined with fast track ( FT ) or st and ard care , is the optimal approach for patients undergoing segmental resection for colon cancer . Summary Background Data : Important developments in elective colorectal surgery are the introduction of laparoscopy and implementation of FT care , both focusing on faster recovery . Methods : In a 9-center trial , patients eligible for segmental colectomy were r and omized to laparoscopic or open colectomy , and to FT or st and ard care , result ing in 4 treatment groups . Primary outcome was total postoperative hospital stay ( THS ) . Secondary outcomes were postoperative hospital stay ( PHS ) , morbidity , reoperation rate , readmission rate , in-hospital mortality , quality of life at 2 and 4 weeks , patient satisfaction and in-hospital costs . Four hundred patients were required to find a minimum difference of 1 day in hospital stay . Results : Median THS in the laparoscopic/FT group was 5 ( interquar-tile range : 4–8 ) days ; open/FT 7 ( 5–11 ) days ; laparoscopic/st and ard 6 ( 4.5–9.5 ) days , and open/st and ard 7 ( 6–13 ) days ( P Median PHS in the laparoscopic/FT group was 5 ( 4–7 ) days ; open/FT 6 ( 4.5–10 ) days ; laparoscopic/st and ard 6 ( 4–8.5 ) days and open/st and ard 7 ( 6–10.5 ) days ( P reduce hospital stay and morbidity . Conclusions : Optimal perioperative treatment for patients requiring segmental colectomy for colon cancer is laparoscopic resection embedded in a FT program . If open surgery is applied , it is preferentially done in FT care . This study was registered under NTR222 ( www.trialregister.nl )",
"Objective : A prospect i ve r and omized controlled trial ( RCT ) of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer . Aims : This study evaluates the use of a multimodal package in colorectal cancer surgery in the context of an RCT . Methods : Patients for elective resection for colorectal cancer were offered trial entry . Participants were stratified by sex and requirement for a total mesorectal excision and central ly r and omized . Multimodal patients received intravenous fluid restriction , unrestricted oral intake with prokinetic agents , early ambulation , and fixed regimen epidural analgesia . Control patients received intravenous fluids to prevent oliguria , restricted oral intake until return of bowel motility , and weaning regimen epidural analgesia . Adherence to both regimens was reinforced using a daily checklist and protocol guidance sheets . Discharge decision was made using preagreed criteria . The primary endpoint was postoperative stay , and achievement of independence milestones . Secondary endpoints were postoperative complications , readmission rates , and mortality . Analysis was by intention to treat . Results : Seventy patients were recruited . Approximately one fourth underwent TME . Median ages were similar ( 69.3 vs. 73.0 years ) . The median stay was significantly reduced in the multimodal group ( 5 vs. 7 days ; P control arm were 2.5 times as likely to require a postoperative stay of more than 5 days . Patients in the multimodal group had less cardiorespiratory and anastomotic complications but more readmissions . There were 2 deaths , both controls . Conclusions : This RCT provides level 1b evidence that a multimodal management protocol can significantly reduce postoperative stay following colorectal cancer surgery . Morbidity and mortality are not increased",
"Aim : Enhanced recovery after surgery ( ERAS ) is a multimodal approach that aims to optimize perioperative treatment . Whether elderly patients receiving colorectal surgery can adhere to and benefit from an ERAS approach is uncertain . The aim of this study was to compare patients in different age groups participating in an ERAS program . Method : In this sub study of a r and omized controlled trial , we analyzed the interventional ERAS arm of adult patients eligible for laparoscopic or open colorectal resection with regard to the importance of age . Patients were divided into three groups based on age : ≤65 years ( n = 79 ) , 66 - 79 years ( n = 56 ) , and ≥80 years ( n = 19 ) . The primary end point was total postoperative hospital stay ( THS ) . Secondary end points were postoperative hospital stay , postoperative complications , postoperative C-reactive protein levels , readmission rate , mortality , and patient adherence to the different ERAS elements . All parameters and measuring the adherence to the ERAS protocol were recorded before surgery , on the day of the operation , and daily until discharge . Results : There were no significant differences in length of THS between age groups ( ≤65 years , median 5 [ range 2 - 47 ] days ; 66 - 79 years , median 5.5 [ range 2 - 36 ] days ; ≥80 years , median 7 [ range 3 - 50 ] days ; p = .53 ) . All secondary outcomes were similar between age groups . Patient adherence to the ERAS protocol was as good in the elderly as it was in the younger patients . Conclusion : Elderly patients adhered to and benefited from an ERAS program , similar to their younger counterparts",
"ERAS program applied to colorectal laparoscopic surgery is well known to reduce hospitalization improving short terms outcomes and minimizing the Surgical Stress Response . However its effectiveness in elderly population is yet to be demonstrated . The primary aim of this study is to compare the level of immune and nutritional serum indexes across surgery in patients aged over 70 years old undergoing elective colorectal laparoscopic surgery within an ERAS protocol or according to a St and ard program . 83 patients undergoing colorectal laparoscopic surgery were enrolled and r and omized in two groups ( ERAS Group 40 , St and ard Group 43 ) within a larger r and omized trial on a general population . Surgical stress parameters were collected preoperatively , 1 , 3 and 5 days after surgery . Nutritional parameters were collected preoperatively , 1 and 5 days after surgery . Short Term Outcomes were also prospect ively assessed . IL-6 levels were lower in the EG on 1 , 3 , and 5 days post-operatively ( p 0.05 ) . IL-6 levels in the Enhanced group returned to pre operative level 3 days after surgery . C-reactive protein level was lower in the Enhanced group on day 1 , 3 , and 5 ( p 0.05 ) . There was no difference in Cortisol and Prolactin levels between groups . Prealbumin serum level was higher on day 5 ( p 0.05 ) compared to st and ard group . Postoperative outcomes in terms of normal bowel function and length of hospital stay were significantly improved in the ERAS group . Colorectal laparoscopic surgery within an ERAS prototcol in elderly patients affects Surgical Stress Response , decreasing IL-6 and CRP levels postoperatively and improving Prealbumin post operative synthesis",
"Background : Enhanced Recovery After Surgery ( ERAS ) program applied to colorectal laparoscopic surgery is well known to reduce hospitalization improving short-terms outcomes . Its goal is to minimize the surgical stress response in order to maintain the physiological homeostasis altered by surgery . However , there is little knowledge about the involved dynamics in the reduction of the surgical stress that these programs allow . The primary aim of this study was to compare the level of immune and nutritional serum investigators across surgery in patients undergoing elective colorectal laparoscopic surgery within an ERAS protocol or according to a st and ard care program . Material s and Methods : One hundred forty patients undergoing major colorectal laparoscopic surgery were enrolled and r and omized in 2 groups ( 70 per arm ) . Cortisol , C-reactive protein ( CRP ) , white blood cell count , prolactin , interleukin (IL)-6 levels were collected preoperatively , 1 , 3 , and 5 days after surgery . Transferrin , prealbumin , albumin , and triglyceride level were collected preoperatively , 1 and 5 days after surgery . Short-term outcomes were also prospect ively assessed . Results : IL-6 levels were lower in the ERAS group on 1 , 3 , and 5 days postoperatively ( P IL-6 levels in the enhanced group , differently from control group , returned to preoperative level 3 days after surgery . CRP level was lower in the enhanced group on day 1 , 3 , and 5 ( P cortisol and prolactin levels between groups . Prealbumin serum level was higher on day 5 ( P ERAS protocol applied to colorectal laparoscopic surgery affects surgical stress response , decreasing IL-6 and CRP levels postoperatively and improving prealbumin postoperative synthesis",
"Background This review aims to present a consensus for optimal perioperative care in colonic surgery and to provide grade d recommendations for items for an evidence d-based enhanced perioperative protocol . Methods Studies were selected with particular attention paid to meta-analyses , r and omised controlled trials and large prospect i ve cohorts . For each item of the perioperative treatment pathway , available English- language literature was examined , review ed and grade d. A consensus recommendation was reached after critical appraisal of the literature by the group . Results For most of the protocol items , recommendations are based on good- quality trials or meta-analyses of good- quality trials ( quality of evidence and recommendations according to the GRADE system ) . Conclusions Based on the evidence available for each item of the multimodal perioperative care pathway , the Enhanced Recovery After Surgery ( ERAS ) Society , International Association for Surgical Metabolism and Nutrition ( IASMEN ) and European Society for Clinical Nutrition and Metabolism ( ESPEN ) present a comprehensive evidence -based consensus review of perioperative care for colonic surgery"
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Background In the general population , at least 50 % of time awake is spent in sedentary behaviours . Sedentary behaviours are activities that expend less energy than 1.5 metabolic equivalents , such as sitting . The amount of time spent in sedentary behaviours is a risk factor for diseases such as type 2 diabetes , cardiovascular disease , and death from all causes . Even individuals meeting physical activity guidelines are at a higher risk of premature death and adverse metabolic outcomes if they sit for extended intervals . The associations between sedentary behaviour with type 2 diabetes and with impaired glucose tolerance are stronger for women than for men . It is not known whether sedentary behaviour in pregnancy influences pregnancy outcomes , but if those negative outcomes observed in general adult population also occur in pregnancy , this could have implication s for adverse outcomes for mothers and offspring . We aim ed to determine the proportion of time spent in sedentary behaviours among pregnant women , and the association of sedentary behaviour with pregnancy outcomes in mothers and offspring . Methods Two research ers independently performed the literature search using 5 different electronic bibliographic data bases . Studies were included if sedentary behaviours were assessed during pregnancy . Two review ers independently assessed the articles for quality and bias , and extracted the relevant information . Results We identified 26 studies meeting the inclusion criteria . Pregnant women spent more than 50 % of their time in sedentary behaviours . Increased time in sedentary behaviour was significantly associated with higher levels of C Reactive Protein and LDL Cholesterol , and a larger newborn abdominal circumference . Sedentary behaviours were significantly higher among women who delivered macrosomic infants . Discrepancies were found in associations of sedentary behaviour with gestational weight gain , hypertensive disorders , and birth weight . No consistent associations were found between sedentary behaviour and other variables such as gestational diabetes . There was considerable variability in study design and methods of assessing sedentary behaviour . Conclusions Our review highlights the significant time spent in sedentary behaviour during pregnancy , and that sedentary behaviour may impact on pregnancy outcomes for both mother and child . The considerable heterogeneity in the literature suggests future studies should use robust methodology for quantifying sedentary behaviour
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"Objective . To evaluate the relationship of physical activity ( PA ) and sedentary behaviour with gestational weight gain ( GWG ) and birth weight . Design . Combined data from two prospect i ve studies : ( 1 ) Noneiparous pregnant women without BMI restrictions and ( 2 ) overweight and obese pregnant women at risk for gestational diabetes . Methods . Daily PA and sedentary behaviour were measured with an accelerometer around 15 and at 32–35 weeks of gestation . The association between time spent in moderate-to-vigorous PA ( MVPA ) and in sedentary activities with GWG and birth weight was determined . Main outcome measures were GWG between 15 and 32 weeks of gestation , average GWG per week , and birth weight . Results . We studied 111 women . Early in pregnancy , 32 % of women spent ≥30 minutes/day in at least moderate PA versus 12 % in late pregnancy . No significant associations were found between time spent in MVPA or sedentary behaviour with GWG or birth weight . Conclusions . We found no relation between MVPA and sedentary behaviour with GWG or birth weight . The small percentage of women meeting the recommended levels of PA indicates the need to inform and support pregnant women to maintain regular PA , as there seems to be no adverse effect on birth weight and maintaining PA increases overall health",
"The potential relationship between daily physical activity and pregnancy outcome remains unclear because of the wide variation in study design s and physical activity assessment measures . We sought to prospect ively quantify the potential effects of the various domains of physical activity on selected birth outcomes in a large unselected population . The sample consisted of 11,759 singleton pregnancies from the Avon longitudinal study of parents and children , United Kingdom . Information on daily physical activity was collected by postal question naire for self-report measures . Main outcome measures were birth weight , gestational age at delivery , preterm birth and survival . After controlling for confounders , a sedentary lifestyle and paid work during the second trimester of pregnancy were found to be associated with a lower birth weight , while ‘ bending and stooping ’ and ‘ working night shifts ’ were associated with a higher birth weight . There was no association between physical exertion and duration of gestation or survival . Repetitive boring tasks during the first trimester was weakly associated with an increased risk of preterm birth ( of preterm birth ( adjusted OR = 0.73 , 95 % CI 0.63–0.84 ) . Dem and ing physical activities do not have a harmful effect on the selected birth outcomes while a sedentary lifestyle is associated with a lower birth weight . In the absence of either medical or obstetric complications , pregnant women may safely continue their normal daily physical activities should they wish to do so",
"Background Physical activity ( PA ) interventions design ed to prevent prenatal complications have focused on increasing moderate PA yielding conflicting results . Minimal attention has focused on the evaluation of sleep , sedentary behavior ( SB ) , light activity or total daily PA during pregnancy . The purpose of this prospect i ve , longitudinal study was to 1 ) objective ly quantify and compare habitual PA and SB during the 2nd and 3rd trimester ; and 2 ) evaluate differences in activity patterns for women meeting prenatal PA guidelines versus those that did not . Methods Forty-six participants wore 2 PA monitors ( SenseWear ® Mini and activPAL ™ ) during week 18 and week 35 of pregnancy . We compared differences in sleep duration , postural allocation , daily steps , and PA between the 2nd and 3rd trimester and for women who met and did not meet PA guidelines . Results During the 2nd trimester , 30 % of the women ’s day ( 24-hours ) was total sleep ; 52 % SB ; 13 % light ; 3 % moderate ; and 0 % vigorous PA . Light ( P = 0.05 ) , vigorous ( P = 0.02 ) , and moderate-vigorous PA ( MET-minutes ; P = 0.02 ) , decreased with a trend in increased SB ( P = 0.07 ) . Activity of other intensities and sleep duration did not significantly change . Only 39 % and 37 % of participants slept between 7–9 hours/night at week 18 and 35 , respectively . Forty-six percent ( n = 21 ) and 28 % ( n = 13 ) of participants met prenatal PA guidelines during the 2nd and 3rd trimester , respectively . At week 18 , no differences in total sleep , SB , or light PA existed for women who met PA guidelines versus those who did not ; total PA was significantly greater for women who met guidelines . At week 35 , women that met PA guidelines had significantly less SB ( P pregnant women spend the majority of their day in SB . Significant reductions in total activity across pregnancy may be attributed , in part to shifts in light PA and increased SB . Based on the lifestyle of our sample , regardless of meeting PA guidelines in mid-pregnancy , no significant difference exists in time spent in SB , however meeting PA recommendations in late pregnancy may reduce SB . Future interventions should target reducing SB by increasing light and moderate PA beyond volitional exercise",
"Objective To determine the effect of antenatal dietary and lifestyle interventions on health outcomes in overweight and obese pregnant women . Design Multicentre r and omised trial . We utilised a central telephone r and omisation server , with computer generated schedule , balanced variable blocks , and stratification for parity , body mass index ( BMI ) category , and hospital . Setting Three public maternity hospitals across South Australia . Participants 2212 women with a singleton pregnancy , between 10 + 0 and 20 + 0 weeks ’ gestation , and BMI ≥25 . Interventions 1108 women were r and omised to a comprehensive dietary and lifestyle intervention delivered by research staff ; 1104 were r and omised to st and ard care and received pregnancy care according to local guidelines , which did not include such information . Main outcome measures Incidence of infants born large for gestational age ( birth weight ≥90th centile for gestation and sex ) . Prespecified secondary outcomes included birth weight > 4000 g , hypertension , pre-eclampsia , and gestational diabetes . Analyses used intention to treat principles . Results 2152 women and 2142 liveborn infants were included in the analyses . The risk of the infant being large for gestational age was not significantly different in the two groups ( lifestyle advice 203/1075 ( 19 % ) v st and ard care 224/1067 ( 21 % ) ; adjusted relative risk 0.90 , 95 % confidence interval 0.77 to 1.07 ; P=0.24 ) . Infants born to women after lifestyle advice were significantly less likely to have birth weight above 4000 g ( lifestyle advice 164/1075 ( 15 % ) v st and ard care 201/1067 ( 19 % ) ; 0.82 , 0.68 to 0.99 ; number needed to treat ( NNT ) 28 , 15 to 263 ; P=0.04 ) . There were no differences in maternal pregnancy and birth outcomes between the two treatment groups . Conclusions For women who were overweight or obese , the antenatal lifestyle advice used in this study did not reduce the risk delivering a baby weighing above the 90th centile for gestational age and sex or improve maternal pregnancy and birth outcomes . Trial registration Australian and New Zeal and Clinical Trials Registry ( ACTRN12607000161426 )",
"BACKGROUND Behavioural interventions might improve clinical outcomes in pregnant women who are obese . We aim ed to investigate whether a complex intervention addressing diet and physical activity could reduce the incidence of gestational diabetes and large-for-gestational-age infants . METHODS The UK Pregnancies Better Eating and Activity Trial ( UPBEAT ) is a r and omised controlled trial done at antenatal clinics in eight hospitals in multi-ethnic , inner-city locations in the UK . We recruited pregnant women ( 15 - 18 weeks plus 6 days of gestation ) older than 16 years who were obese ( BMI ≥30 kg/m(2 ) ) . We r and omly assigned participants to either a behavioural intervention or st and ard antenatal care with an internet-based , computer-generated , r and omisation procedure , minimising by age , ethnic origin , centre , BMI , and parity . The intervention was delivered once a week through eight health trainer-led sessions . Primary outcomes were gestational diabetes ( diagnosed with an oral glucose tolerance test and by criteria from the International Association of Diabetes in Pregnancy Study Groups ) and large-for-gestational-age infants ( ≥90th customised birthweight centile ) . Analysis was by intention to treat . This trial is registered with Current Controlled Trials , ISCRTN89971375 . Recruitment and pregnancy outcomes are complete but childhood follow-up is ongoing . FINDINGS Between March 31 , 2009 , and June 2 , 2014 , we assessed 8820 women for eligibility and recruited 1555 , with a mean BMI of 36·3 kg/m(2 ) ( SD 4·8 ) . 772 were r and omly assigned to st and ard antenatal care and 783 were allocated the behavioural intervention , of which 651 and 629 women , respectively , completed an oral glucose tolerance test . Gestational diabetes was reported in 172 ( 26 % ) women in the st and ard care group compared with 160 ( 25 % ) in the intervention group ( risk ratio 0·96 , 95 % CI 0·79 - 1·16 ; p=0·68 ) . 61 ( 8 % ) of 751 babies in the st and ard care group were large for gestational age compared with 71 ( 9 % ) of 761 in the intervention group ( 1·15 , 0·83 - 1·59 ; p=0·40 ) . Thus , the primary outcomes did not differ between groups , despite improvements in some maternal secondary outcomes in the intervention group , including reduced dietary glycaemic load , gestational weight gain , and maternal sum-of-skinfold thicknesses , and increased physical activity . Adverse events included neonatal death ( two in the st and ard care group and three in the intervention group ) and fetal death in utero ( ten in the st and ard care group and six in the intervention group ) . No maternal deaths were reported . Incidence of miscarriage ( 2 % in the st and ard care group vs 2 % in the intervention group ) , major obstetric haemorrhage ( 1 % vs 3 % ) , and small-for-gestational-age infants ( ≤5th customised birthweight centile ; 6 % vs 5 % ) did not differ between groups . INTERPRETATION A behavioural intervention addressing diet and physical activity in women with obesity during pregnancy is not adequate to prevent gestational diabetes , or to reduce the incidence of large-for-gestational-age infants . FUNDING National Institute for Health Research , Guys and St Thomas ' Charity , Chief Scientist Office Scotl and , Tommy 's Charity",
"In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias",
"UNLABELLED Studies conducted among nonpregnant population s have observed an association between sedentary behavior and glucose intolerance . Few studies have investigated this association during pregnancy , particularly among Latina women , a population with higher rates of sedentary behavior and abnormal glucose tolerance ( AGT ) as compared with non-Latina white women . OBJECTIVE The purpose of this study was to estimate the association between sedentary behavior and AGT . RESEARCH DESIGN AND METHODS We used data from the Latina gestational diabetes mellitus study , a prospect i ve cohort of 1231 Latina prenatal care patients in western Massachusetts . Sedentary behavior was assessed by bilingual interviewers using a modified version of the Kaiser Physical Activity Survey in prepregnancy , early pregnancy , and midpregnancy and defined as hours spent TV watching , frequency of sitting at work , and participation in sports or exercise activity as well as a derived composite of total sedentary activity . AGT was measured at 24 - 28 wk of gestation and abstract ed from medical records after delivery . Multivariate logistic regression was used to calculate odds ratios and 95 % confidence intervals . RESULTS A total of 12 % ( n = 119 ) of participants were classified as having AGT . After adjusting for AGT risk factors , sedentary behaviors in prepregnancy or in early pregnancy were not associated with AGT . However , in midpregnancy , low levels of participation in sports or exercise ( odds ratio = 2.01 , 95 % CI = 1.01 - 4.02 ) and increasing total sedentary activity ( Ptrend = 0.003 ) were associated with increased risk for AGT . CONCLUSIONS Findings suggest an association between sedentary activity in midpregnancy and risk of AGT in this understudied population",
"PURPOSE Although moderate-to-vigorous physical activity is related to premature mortality , the relationship between sedentary behaviors and mortality has not been fully explored and may represent a different paradigm than that associated with lack of exercise . We prospect ively examined sitting time and mortality in a representative sample of 17,013 Canadians 18 - 90 yr of age . METHODS Evaluation of daily sitting time ( almost none of the time , one fourth of the time , half of the time , three fourths of the time , almost all of the time ) , leisure time physical activity , smoking status , and alcohol consumption was conducted at baseline . Participants were followed prospect ively for an average of 12.0 yr for the ascertainment of mortality status . RESULTS There were 1832 deaths ( 759 of cardiovascular disease ( CVD ) and 547 of cancer ) during 204,732 person-yr of follow-up . After adjustment for potential confounders , there was a progressively higher risk of mortality across higher levels of sitting time from all causes ( hazard ratios ( HR ) : 1.00 , 1.00 , 1.11 , 1.36 , 1.54 ; P for trend Age-adjusted all-cause mortality rates per 10,000 person-yr of follow-up were 87 , 86 , 105 , 130 , and 161 ( P for trend sitting time and mortality from all causes and CVD , independent of leisure time physical activity . In addition to the promotion of moderate-to-vigorous physical activity and a healthy weight , physicians should discourage sitting for extended periods",
"Even when adults meet physical activity guidelines , sitting for prolonged periods can compromise metabolic health . Television ( TV ) time and objective measurement studies show deleterious associations , and breaking up sedentary time is beneficial . Sitting time , TV time , and time sitting in automobiles increase premature mortality risk . Further evidence from prospect i ve studies , intervention trials , and population -based behavioral studies is required",
"Objective Hispanic women have high rates of excessive and inadequate gestational weight gain ( GWG ) according to Institute of Medicine ( IOM ) guidelines . Observational studies suggest that physical activity may be associated with GWG but have been conflicting and were largely conducted in non-Hispanic white population s. Design and Methods We prospect ively evaluated the association between physical activity and compliance with GWG guidelines , total GWG , and rate of GWG among 1,276 Hispanic participants in Proyecto Buena Salud , a cohort study in Western Massachusetts . The Pregnancy Physical Activity Question naire was used to assess pre , early , mid , and late pregnancy physical activity according to both intensity ( i.e. , sedentary , moderate , and vigorous ) and type ( i.e. , housework/caregiving , occupational , and sports/exercise ) . Results A total of 26.9 % of women gained within IOM guidelines , 21.2 % had inadequate GWG , and 51.9 % experienced excessive GWG . Overall , we did not observe statistically significant associations between type or intensity of physical activity during pre , early , mid , and late pregnancy and inadequate or excessive GWG , total GWG , or rate of GWG . Conclusions In this prospect i ve cohort study of Hispanic women , after controlling for important risk factors , pregnancy physical activity did not appear to be associated with GWG",
"Objective : Prior studies of the association between physical activity and hypertensive disorders of pregnancy have been conflicting ; the majority focused on leisure-time activity only , did not use physical activity question naires vali date d for pregnancy , and were conducted in primarily non-Hispanic white population s. Methods : We prospect ively evaluated this association among 1240 Hispanic women in Proyecto Buena Salud . The Pregnancy Physical Activity Question naire , vali date d for use in pregnancy , was used to assess pre- and early pregnancy sports/exercise , household/caregiving , occupational and transportation activity . Diagnoses of hypertensive disorders of pregnancy were based on medical record abstract ion and confirmed by the study obstetrician . Results : A total of 49 women ( 4.0 % ) were diagnosed with a hypertensive disorder of pregnancy , including 32 women ( 2.6 % ) with pre-eclampsia . In age-adjusted analyses , high levels of early pregnancy household/caregiving activity were associated with reduced risk of total hypertensive disorders ( OR = 0.4 , 95 % CI 0.1–0.9 ) and pre-eclampsia ( OR = 0.3 , 95 % CI 0.1–0.9 ) relative to low levels ; however , these findings were no longer statistically significant in multivariable models . Pre-pregnancy activity and pattern of activity from pre- to early-pregnancy were not significantly associated with risk . Finally , sedentary behavior was not significantly associated with hypertensive disorders . Conclusion : Findings from this prospect i ve study of Hispanic women were consistent with those of prior prospect i ve cohorts indicating that physical activity prior to and during early pregnancy does not significantly reduce risk of hypertensive disorders of pregnancy",
"CONTEXT Current public health campaigns to reduce obesity and type 2 diabetes have largely focused on increasing exercise , but have paid little attention to the reduction of sedentary behaviors . OBJECTIVE To examine the relationship between various sedentary behaviors , especially prolonged television ( TV ) watching , and risk of obesity and type 2 diabetes in women . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study conducted from 1992 to 1998 among women from 11 states in the Nurses ' Health Study . The obesity analysis included 50 277 women who had a body mass index ( BMI ) of less than 30 and were free from diagnosed cardiovascular disease , diabetes , or cancer and completed questions on physical activity and sedentary behaviors at baseline . The diabetes analysis included 68 497 women who at baseline were free from diagnosed diabetes mellitus , cardiovascular disease , or cancer . MAIN OUTCOME MEASURES Onset of obesity and type 2 diabetes mellitus . RESULTS During 6 years of follow-up , 3757 ( 7.5 % ) of 50 277 women who had a BMI of less than 30 in 1992 became obese ( BMI > or = 30 ) . Overall , we documented 1515 new cases of type 2 diabetes . Time spent watching TV was positively associated with risk of obesity and type 2 diabetes . In the multivariate analyses adjusting for age , smoking , exercise levels , dietary factors , and other covariates , each 2-h/d increment in TV watching was associated with a 23 % ( 95 % confidence interval [ CI ] , 17%-30 % ) increase in obesity and a 14 % ( 95 % CI , 5%-23 % ) increase in risk of diabetes ; each 2-h/d increment in sitting at work was associated with a 5 % ( 95 % CI , 0%-10 % ) increase in obesity and a 7 % ( 95 % CI , 0%-16 % ) increase in diabetes . In contrast , st and ing or walking around at home ( 2 h/d ) was associated with a 9 % ( 95 % CI , 6%-12 % ) reduction in obesity and a 12 % ( 95 % CI , 7%-16 % ) reduction in diabetes . Each 1 hour per day of brisk walking was associated with a 24 % ( 95 % CI , 19%-29 % ) reduction in obesity and a 34 % ( 95 % CI , 27%-41 % ) reduction in diabetes . We estimated that in our cohort , 30 % ( 95 % CI , 24%-36 % ) of new cases of obesity and 43 % ( 95 % CI , 32%-52 % ) of new cases of diabetes could be prevented by adopting a relatively active lifestyle ( or = 30 min/d of brisk walking ) . CONCLUSIONS Independent of exercise levels , sedentary behaviors , especially TV watching , were associated with significantly elevated risk of obesity and type 2 diabetes , whereas even light to moderate activity was associated with substantially lower risk . This study emphasizes the importance of reducing prolonged TV watching and other sedentary behaviors for preventing obesity and diabetes",
"Background : Obesity in pregnancy is associated with fetal macrosomia , a raised neonatal fat mass and an increased risk of obesity and poor metabolic health in childhood which persists into adulthood . The offspring of obese women are more likely to be obese than the offspring of lean women when they become pregnant themselves , perpetuating a cycle of obesity and its associated negative metabolic consequences . Increasing physical activity during pregnancy could improve insulin sensitivity and reduce the risk of maternal and offspring adverse outcomes . The UK Pregnancy Better Eating and Activity Trial ( UPBEAT ) is a trial of a complex intervention design ed to improve pregnancy outcomes through dietary changes and physical activity . Data from the pilot trial of 183 women were available for analysis . The relationship between the time spent at different physical activity levels and maternal and infant pregnancy outcomes was examined . Key Messages : Strong evidence exists that physical activity improves insulin sensitivity in non-pregnant population s , and lifestyle interventions of proven effectiveness in non-pregnant population s have been developed . Women who are active in pregnancy demonstrate better glucose control and favourable pregnancy outcomes . There is a lack of effective interventions to support obese pregnant women to be physically active . Conclusions : No difference was detected in objective ly measured physical activity between women r and omised to the intervention and control arms of the UPBEAT pilot trial . Light-intensity physical activity was lower in early pregnancy in women who delivered macrosomic infants . Maternal sedentary time at 35 - 36 weeks ' gestation was positively associated and moderate-intensity physical activity was inversely associated with neonatal abdominal circumference . Maternal physical activity is associated with infant birth weight and abdominal circumference and is an appropriate target for intervention to improve infant outcomes . The challenge remains to develop an effective intervention to support obese pregnant women to be physically active",
"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 A growing body of evidence suggests that physical activity during pregnancy can reduce risk of pregnancy complications . However , factors influencing activity in pregnant Hispanic women , who have high rates of sedentary activity as compared to non-Hispanic whites , are not well characterized . PURPOSE To assess patterns and correlates of physical activity among 1355 participants in Proyecto Buena Salud , a prospect i ve cohort of pregnant Hispanic women in Massachusetts from 2006 to 2011 . METHODS Analyses were conducted in 2012 . Pre- , early- , mid- , and late-pregnancy physical activity were assessed using the Pregnancy Physical Activity Question naire . Women reported the frequency and duration of household/caregiving , occupational , sports/exercise , and transportation activities and were classified according to compliance with American College of Obstetricians and Gynecologists guidelines for physical activity . RESULTS Household/caregiving activity was the primary mode of pregnancy activity ranging from 56 % to 60 % of total activity while sports/exercise contributed the least ( become inactive at any time during pregnancy ( OR=0.15 , 95 % CI=0.04 , 0.56 , p-trend their total physical activity on average 9.73±2.04 MET-hours/week and 12.04±2.39 MET-hours/week , respectively , with the onset of pregnancy ( p levels of total physical activity prior to pregnancy were 87 % less likely to become inactive with the onset of pregnancy than those who were inactive prior to pregnancy ( OR=0.13 , 95 % CI= 0.05 , 0.29 ) . CONCLUSIONS Findings can inform culturally appropriate interventions design ed to reduce pregnancy complications through the promotion of physical activity during pregnancy",
"OBJECTIVES We examined the impact of a prenatal exercise intervention on physical activity in 260 women at risk for gestational diabetes mellitus . METHODS We r and omized participants in the Behaviors Affecting Baby and You ( BABY ) Study , which took place from 2007 to 2012 , to either a 12-week individually tailored , motivationally matched exercise intervention ( n=132 ) or to a comparison health and wellness intervention ( n=128 ) . We assessed physical activity with the Pregnancy Physical Activity Question naire . We used linear mixed models to evaluate the impact of the interventions on change in physical activity according to intensity and type , total walking , and sedentary behavior . RESULTS Compared with the health and wellness arm , the exercise arm had significantly greater increases in sports or exercise activity ( 0.3 vs 5.3 metabolic equivalent of task [ MET ] hours/week ; P total activity ( -42.7 vs -2.1 MET hours/week ; P=.02 ) and activities of moderate to vigorous intensity ( -30.6 vs -10.6 MET hours/week ; P=.05 ) , and was more likely to achieve recommended guidelines for physical activity ( odds ratio=2.12 ; 95 % confidence interval=1.45 , 3.10 ) . CONCLUSIONS These findings extend the previous literature by demonstrating the benefits of a clinical ly feasible exercise intervention in an ethnically and socio-economically diverse population . Given the increased risk of adverse maternal health outcomes in ethnic minority groups , these findings may have important implication s for reducing health disparities"
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Background Testosterone therapy is increasingly promoted . No r and omized placebo-controlled trial has been implemented to assess the effect of testosterone therapy on cardiovascular events , although very high levels of and rogens are thought to promote cardiovascular disease . Methods A systematic review and meta- analysis was conducted of placebo-controlled r and omized trials of testosterone therapy among men lasting 12 + weeks reporting cardiovascular-related events . We search ed PubMed through the end of 2012 using “ ( “ testosterone ” or “ and rogen ” ) and trial and ( “ r and om * ” ) ” with the selection limited to studies of men in English , supplemented by a bibliographic search of the World Health Organization trial registry . Two review ers independently search ed , selected and assessed study quality with differences resolved by consensus . Two statisticians independently abstract ed and analyzed data , using r and om or fixed effects models , as appropriate , with inverse variance weighting . Results Of 1,882 studies identified 27 trials were eligible including 2,994 , mainly older , men who experienced 180 cardiovascular-related events . Testosterone therapy increased the risk of a cardiovascular-related event ( odds ratio ( OR ) 1.54 , 95 % confidence interval ( CI ) 1.09 to 2.18 ) . The effect of testosterone therapy varied with source of funding ( P-value for interaction 0.03 ) , but not with baseline testosterone level ( P-value for interaction 0.70 ) . In trials not funded by the pharmaceutical industry the risk of a cardiovascular-related event on testosterone therapy was greater ( OR 2.06 , 95 % CI 1.34 to 3.17 ) than in pharmaceutical industry funded trials ( OR 0.89 , 95 % CI 0.50 to 1.60 ) . Conclusions The effects of testosterone on cardiovascular-related events varied with source of funding . Nevertheless , overall and particularly in trials not funded by the pharmaceutical industry , exogenous testosterone increased the risk of cardiovascular-related events , with corresponding implication s for the use of testosterone therapy
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"BACKGROUND Enzalutamide ( formerly called MDV3100 ) targets multiple steps in the and rogen-receptor-signaling pathway , the major driver of prostate-cancer growth . We aim ed to evaluate whether enzalutamide prolongs survival in men with castration-resistant prostate cancer after chemotherapy . METHODS In our phase 3 , double-blind , placebo-controlled trial , we stratified 1199 men with castration-resistant prostate cancer after chemotherapy according to the Eastern Cooperative Oncology Group performance-status score and pain intensity . We r and omly assigned them , in a 2:1 ratio , to receive oral enzalutamide at a dose of 160 mg per day ( 800 patients ) or placebo ( 399 patients ) . The primary end point was overall survival . RESULTS The study was stopped after a planned interim analysis at the time of 520 deaths . The median overall survival was 18.4 months ( 95 % confidence interval [ CI ] , 17.3 to not yet reached ) in the enzalutamide group versus 13.6 months ( 95 % CI , 11.3 to 15.8 ) in the placebo group ( hazard ratio for death in the enzalutamide group , 0.63 ; 95 % CI , 0.53 to 0.75 ; P enzalutamide over placebo was shown with respect to all secondary end points : the proportion of patients with a reduction in the prostate-specific antigen ( PSA ) level by 50 % or more ( 54 % vs. 2 % , P soft-tissue response rate ( 29 % vs. 4 % , P quality -of-life response rate ( 43 % vs. 18 % , P time to PSA progression ( 8.3 vs. 3.0 months ; hazard ratio , 0.25 ; P radiographic progression-free survival ( 8.3 vs. 2.9 months ; hazard ratio , 0.40 ; P time to the first skeletal-related event ( 16.7 vs. 13.3 months ; hazard ratio , 0.69 ; P Rates of fatigue , diarrhea , and hot flashes were higher in the enzalutamide group . Seizures were reported in five patients ( 0.6 % ) receiving enzalutamide . CONCLUSIONS Enzalutamide significantly prolonged the survival of men with metastatic castration-resistant prostate cancer after chemotherapy . ( Funded by Medivation and Astellas Pharma Global Development ; AFFIRM Clinical Trials.gov number , NCT00974311 . )",
"CONTEXT Steroid 5α-reductase inhibitors are used to treat benign prostatic hyperplasia and and rogenic alopecia , but the role of 5α-dihydrotestosterone ( DHT ) in mediating testosterone 's effects on muscle , sexual function , erythropoiesis , and other and rogen-dependent processes remains poorly understood . OBJECTIVE To determine whether testosterone 's effects on muscle mass , strength , sexual function , hematocrit level , prostate volume , sebum production , and lipid levels are attenuated when its conversion to DHT is blocked by dutasteride ( an inhibitor of 5α-reductase type 1 and 2 ) . DESIGN , SETTING , AND PATIENTS The 5α-Reductase Trial was a r and omized controlled trial of healthy men aged 18 to 50 years comparing placebo plus testosterone enthanate with dutasteride plus testosterone enanthate from May 2005 through June 2010 . INTERVENTIONS Eight treatment groups received 50 , 125 , 300 , or 600 mg/wk of testosterone enanthate for 20 weeks plus placebo ( 4 groups ) or 2.5 mg/d of dutasteride ( 4 groups ) . MAIN OUTCOME MEASURES The primary outcome was change in fat-free mass ; secondary outcomes : changes in fat mass , muscle strength , sexual function , prostate volume , sebum production , and hematocrit and lipid levels . RESULTS A total of 139 men were r and omized ; 102 completed the 20-week intervention . Men assigned to dutasteride were similar at baseline to those assigned to placebo . The mean fat-free mass gained by the dutasteride groups was 0.6 kg ( 95 % CI , -0.1 to 1.2 kg ) when receiving 50 mg/wk of testosterone enanthate , 2.6 kg ( 95 % CI , 0.9 to 4.3 kg ) for 125 mg/wk , 5.8 kg ( 95 % CI , 4.8 to 6.9 kg ) for 300 mg/wk , and 7.1 kg ( 95 % CI , 6.0 to 8.2 kg ) for 600 mg/wk . The mean fat-free mass gained by the placebo groups was 0.8 kg ( 95 % CI , -0.1 to 1.7 kg ) when receiving 50 mg/wk of testosterone enanthate , 3.5 kg ( 95 % CI , 2.1 to 4.8 kg ) for 125 mg/wk , 5.7 kg ( 95 % CI , 4.8 to 6.5 kg ) for 300 mg/wk , and 8.1 kg ( 95 % CI , 6.7 to 9.5 kg ) for 600 mg/wk . The dose-adjusted differences between the dutasteride and placebo groups for fat-free mass were not significant ( P = .18 ) . Changes in fat mass , muscle strength , sexual function , prostate volume , sebum production , and hematocrit and lipid levels did not differ between groups . CONCLUSION Changes in fat-free mass in response to grade d testosterone doses did not differ in men in whom DHT was suppressed by dutasteride from those treated with placebo , indicating that conversion of testosterone to DHT is not essential for mediating its anabolic effects on muscle . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00493987",
"BACKGROUND Testosterone in Older Men with Mobility Limitations Trial found an increased incidence of cardiovascular events in men r and omized to testosterone , result ing in enrollment cessation by trial 's Data and Safety Monitoring Board . We evaluated changes in gonadal hormones and markers of inflammation and coagulation to eluci date risk factors associated with cardiovascular events . METHODS Men aged 65 years or more , with mobility limitation , total testosterone 100 - 350 ng/dL , or free testosterone less than 50 pg/mL , were r and omized to placebo or 10 g testosterone gel daily for 6 months . Changes in total and free testosterone , estradiol and estrone , C-reactive protein , interleukin 6 , fibrinogen , plasminogen activator inhibitor-1 , and pro-brain naturetic peptide were compared between groups and within the testosterone group between subjects who experienced cardiovascular events and those who did not . RESULTS Of 209 men r and omized ( mean age 74 years ) , gonadal hormones and biomarkers were available in 179 men . Baseline body mass index , gonadal hormones , lipids , Framingham risk scores , and other biomarkers were similar in the two treatment groups . Within the testosterone group , the 6-month increase in free testosterone was significantly greater in men who experienced cardiovascular events than in those who did not [ mean ( 95 % confidence interval ) , 10.6 ( 4.6 - 16.7 ) vs 5.2 ( 3.0 - 7.5 ) ng/dL , p = .05 ] . In multivariable logistic regression analysis , the change in the serum levels of free testosterone was associated with cardiovascular events . CONCLUSION Mobility-limited older men who experienced cardiovascular events had greater increases in serum free testosterone levels than those who did not",
"The association of sex hormone levels with mortality over a median of 16 years of follow-up was evaluated in a prospect i ve cohort study . The study included 1,114 US men who participated in phase 1 ( 1988 - 1991 ) of the Third National Health and Nutrition Examination Survey Mortality Study and had no history of cardiovascular disease or cancer at baseline . Multivariable adjusted hazard ratios for all-cause mortality associated with a decrease in hormone concentration equal to the difference between the 90th and 10th percentiles of the sex hormone distributions were estimated by using proportional hazards regression . The hazard ratios associated with low free testosterone and low bioavailable testosterone levels were 1.43 ( 95 % confidence interval ( CI ) : 1.09 , 1.87 ) and 1.52 ( 95 % CI : 1.15 , 2.02 ) , respectively , for follow-up between baseline and year 9 ; they were 0.94 ( 95 % CI : 0.51 , 1.72 ) and 0.98 ( 95 % CI : 0.56 , 1.72 ) , respectively , for follow-up between year 9 and year 18 . Men with low free and bioavailable testosterone levels may have a higher risk of mortality within 9 years of hormone measurement . Future studies should be conducted to fully characterize the association of low free and bioavailable testosterone concentrations and mortality in men and to describe the mechanism underlying the association",
"BACKGROUND The incidence of thrombotic cardiovascular disease is greater in men than in premenopausal women . Testosterone has been implicated as a significant risk factor for cardiovascular disease and for acute myocardial infa rct ions and strokes in young male athletes who abuse anabolic steroids . Thromboxane A2 ( TXA2 ) is a vasoconstrictor and platelet proaggregatory agent that has been implicated in the pathogenesis of cardiovascular disease . We therefore tested the hypothesis that testosterone regulates the expression of human platelet TXA2 receptors . METHODS AND RESULTS In a double-blind , placebo-controlled , r and omized , parallel-group study , we determined the effects of testosterone cypionate 200 mg IM given twice , 2 weeks apart , or saline placebo in 16 healthy men . Platelet TXA2 receptor density ( Bmax ) and dissociation constant ( Kd ) were measured by use of the TXA2 mimetic 125I-BOP . Platelet aggregation responses to I-BOP and to thrombin and plasma testosterone concentrations were measured before treatment ( pretreatment phase ) , at 2 and 4 weeks ( active phase ) , and again at 8 weeks ( recovery phase ) . Treatment with testosterone was associated with an increase in the Bmax value from 0.95 + /- 0.13 to 2.10 + /- 0.4 pmol/mg protein ( n = 9 ) , with a peak effect at 4 weeks ( P = .001 ) , returning to baseline by 8 weeks . There was no significant change in Bmax values in the saline-treated group . The Kd values were unchanged . Testosterone treatment was associated with a significant increase in the maximum platelet aggregation response to I-BOP ( P EC50 values were not significantly changed . Platelet TXA2 receptor density was positively correlated ( r = .56 , P Testosterone regulates the expression of platelet TXA2 receptors in humans . This may contribute to the thrombogenicity of and rogenic steroids",
"Older men , particularly those with low serum testosterone ( T ) levels , might benefit from T therapy to improve bone mineral density ( BMD ) and reduce fracture risk . Concerns exist , however , about the impact of T therapy on the prostate in older men . We hypothesized that the combination of T and finasteride ( F ) , a 5 alpha-reductase inhibitor , might increase BMD in older men without adverse effects on the prostate . Seventy men aged 65 yr or older , with a serum T less than 12.1 nmol/liter on two occasions , were r and omly assigned to receive one of three regimens for 36 months : T enanthate , 200 mg i m every 2 wk with placebo pills daily ( T-only ) ; T enanthate , 200 mg every 2 wk with 5 mg F daily ( T+F ) ; or placebo injections and pills ( placebo ) . Low BMD was not an inclusion criterion . We obtained serial measurements of BMD of the lumbar spine and hip by dual x-ray absorptiometry . Prostate-specific antigen ( PSA ) and prostate size were measured at baseline and during treatment to assess the impact of therapy on the prostate . Fifty men completed the 36-month protocol . By an intent-to-treat analysis including all men for as long as they contributed data , T therapy for 36 months increased BMD in these men at the lumbar spine [ 10.2 + /- 1.4 % ( mean percentage increase from baseline + /- SEM ; T-only ) and 9.3 + /- 1.4 % ( T+F ) vs. 1.3 + /- 1.4 % for placebo ( P hip [ 2.7 + /- 0.7 % ( T-only ) and 2.2 + /- 0.7 % ( T+F ) vs. -0.2 + /- 0.7 % for placebo , ( P increases in BMD were seen also in the intertrochanteric and trochanteric regions of the hip . After 6 months of therapy , urinary deoxypyridinoline ( a bone-resorption marker ) decreased significantly compared with baseline in both the T-only and T+F groups ( P PSA increased significantly from baseline in the T-only group ( P Prostate volume increased in all groups during the 36-month treatment period , but this increase was significantly less in the T+F group compared with both the T-only and placebo groups ( P = 0.02 ) . These results demonstrate that T therapy in older men with low serum T increases vertebral and hip BMD over 36 months , both when administered alone and when combined with F. This finding suggests that dihydrotestosterone is not essential for the beneficial effects of T on BMD in men . In addition , the concomitant administration of F with T appears to attenuate the impact of T therapy on prostate size and PSA and might reduce the chance of benign prostatic hypertrophy or other prostate-related complications in older men on T therapy . These findings have important implication s for the prevention and treatment of osteoporosis in older men with low T levels",
"And rogen-deprivation therapy ( ADT ) is a widely used treatment for prostate cancer . Recently , several studies have reported an association between ADT and an increased risk of cardiovascular events , including myocardial infa rct ion and cardiovascular mortality.1 - 5 These reports have led to increased interest and discussion regarding the metabolic effects of ADT and its possible association with increased cardiovascular risk . In addition , likely as a result of these reports , internists , endocrinologists , and cardiologists are now being consulted regarding the evaluation and management of patients in whom ADT is being initiated . Most of these physicians are not aware of the possible effects of ADT on cardiovascular risk factors or the issues regarding ADT and cardiovascular disease . Therefore , this multidisciplinary writing group has been commissioned to review and summarize the metabolic effects of ADT , to evaluate the data regarding a possible relation between ADT and cardiovascular events in patients with prostate cancer , and to generate suggestions regarding the evaluation and management of patients , both with and without known cardiac disease , in whom ADT is being initiated ( Table 1 ) . TABLE 1 Prospect i ve Studies of the Effects of ADT on Cardiac Risk Factors ADT was first used in prostate cancer for patients with overt metastatic disease,7 and it remains the mainstay of therapy for this group . ADT combined with external-beam radiation therapy is a st and ard of care in the treatment of men with high-risk prostate cancer , on the basis of evidence that shows a survival benefit in multiple r and omized controlled trials.8 - 13 However , ADT is also often used for other prostate cancer states ( eg , for prostate volume reduction in men planning to undergo definitive local therapy with brachytherapy , or in the case of rising prostate-specific antigen after definitive local treatment),14,15 and in these cases , its role in prolonging survival is less certain",
"BACKGROUND A large proportion of men over 65 years of age have bioavailable testosterone levels below the reference range of young adult men . The impact of this on musculoskeletal health and the potential for improvement in function in this group with testosterone supplementation require investigation . METHODS Sixty-seven men ( mean age 76 + /- 4 years , range 65 - -87 ) with bioavailable testosterone levels below 4.44 nmol/l ( lower limit for adult normal range ) were r and omized to receive transdermal testosterone ( two 2.5-mg patches per day ) or placebo patches for 1 year . All men received 500 mg supplemental calcium and 400 IU vitamin D. Outcome measures included sex hormones ( testosterone , bioavailable testosterone , sex-hormone binding globulin [ SHBG ] , estradiol , and estrone ) , bone mineral density ( BMD ; femoral neck , Ward 's triangle , trochanter , lumbar spine , and total body ) , bone turnover markers , lower extremity muscle strength , percent body fat , lean body mass , hemoglobin , hematocrit , prostate symptoms , and prostate specific antigen ( PSA ) levels . RESULTS Twenty-three men ( 34 % ) withdrew from the study ; 44 men completed the trial . In these men , bioavailable testosterone levels increased from 3.2 + /- 1.2 nmol/l ( SD ) to 5.6 + /- 3.5 nmol/l ( p estradiol levels in either group , estrone levels increased in the testosterone group ( 103 + /- 26 pmol/l to 117 + /- 33 pmol/l ; p femoral neck BMD , whereas the control group lost 1.6 % over 12 months ( p = .015 ) . No significant changes were seen in markers of bone turnover in either group . Improvements in muscle strength were seen in both groups at 12 months compared with baseline scores . Strength increased 38 % ( p = .017 ) in the testosterone group and 27 % in the control group ( p = .06 ) , with no statistical difference between the groups . In the testosterone group , body fat decreased from 26.3 + /- 5.8 % to 24.6 + /- 6.5 % ( p = .001 ) , and lean body mass increased from 56.2 + /- 5.3 kg to 57.2 + /- 5.1 kg ( p = .001 ) , whereas body mass did not change . Men receiving testosterone had an increase in PSA from 2.0 + /- 1.4 microg/l to 2.6 + /- 1.8 microg/l ( p = .04 ) , whereas men receiving placebo had an increase in PSA from 1.9 + /- 1.0 microg/l to 2.2 + /- 1.5 microg/l ( p = .09 ) . No significant differences between groups were seen in hemoglobin , hematocrit , symptoms or signs of benign prostate hyperplasia , or PSA levels . CONCLUSIONS Transdermal testosterone ( 5 mg/d ) prevented bone loss at the femoral neck , decreased body fat , and increased lean body mass in a group of healthy men over age 65 with low bioavailable testosterone levels . In addition , both testosterone and placebo groups demonstrated gains in lower extremity muscle strength , possibly due to the beneficial effects of vitamin D. Testosterone did result in a modest increase in PSA levels but result ed in no change in signs or symptoms of prostate hyperplasia",
"The indication for testosterone therapy in aging hypogonadal men without hypothalamic , pituitary , or testicular disease remains to be eluci date d. The aim of this study was to investigate the effect of testosterone therapy on insulin sensitivity , substrate metabolism , body composition , and lipids in aging men with low normal bioavailable testosterone levels using a predefined cutoff level for bioavailable testosterone . A r and omized , double-blinded , placebo-controlled study of testosterone treatment ( gel ) was done on 38 men , aged 60–78 years , with bioavailable testosterone 94 cm . Insulin-stimulated glucose disposal ( Rd ) and substrate oxidation were assessed by euglycemic hyperinsulinemic clamps combined with indirect calorimetry . Lean body mass ( LBM ) and total fat mass ( TFM ) were measured by dual x-ray absorptiometry , and serum total testosterone was measured by t and em mass spectrometry . Bioavailable testosterone was calculated . Coefficients ( b ) represent the placebo-controlled mean effect of intervention . LBM ( b = 1.9 kg , p = 0.003 ) increased while HDL – cholesterol ( b = −0.12 mmol/l , p = 0.043 ) and TFM decreased ( b = −1.2 kg , p = 0.038 ) in the testosterone group compared to placebo . Basal lipid oxidation ( b = 5.65 mg/min/m2 , p = 0.045 ) increased and basal glucose oxidation ( b = −9.71 mg/min/m2 , p = 0.046 ) decreased in response to testosterone therapy even when corrected for changes in LBM . No significant changes in insulin-stimulated Rd was observed ( b = −0.01mg/min/m2 , p = 0.92 ) . Testosterone therapy increased muscle mass and lipid oxidation in aging men with low normal bioavailable testosterone levels ; however , our data did not support an effect of testosterone on whole-body insulin sensitivity using the euglycemic hyperinsulinemic clamp technique",
"Long-term glucocorticoid therapy in men is associated with loss of bone and muscle mass as well as a decrease in serum testosterone . We tested the effect of two and rogens , testosterone and its minimally aromatizable analog n and rolone , on muscle mass ( dual x-ray absorptiometry ) , muscle strength ( knee flexion and extension by isokinetic dynamometry ) , bone mineral density ( BMD ) , and quality of life ( Qualeffo-41 question naire ) in 51 men on a mean daily prednisone dose of 12.6 + /- 2.2 mg . Men were r and omized , double blind , to testosterone ( 200 mg mixed esters ) , n and rolone decanoate ( 200 mg ) , or placebo given every fortnight by i m injection for 12 months . At 12 months , both and rogens increased muscle mass ( mean change from baseline + 3.5 % , + 5.8 % , and -0.9 % in testosterone , n and rolone , and placebo groups , respectively , P muscle strength ( P Lumbar spine BMD increased significantly only in men treated with testosterone ( 4.7 + /- 1.1 % , P hip or total body BMD . Testosterone , but not n and rolone or placebo , improved overall quality of life ( P and rogen therapy may have a role in ameliorating adverse effects of glucocorticoid therapy such as muscle and bone loss and aromatization is necessary for and rogen action on bone but not on muscle",
"INTRODUCTION Male hypogonadism is a significant and growing problem that can be successfully treated with testosterone replacement therapy . A new formulation of testosterone gel ( 1.62 % ) was developed with increased viscosity , reduced volume of application , and increased skin permeation compared with other currently available testosterone gels . AIM To evaluate the efficacy and safety of titrated doses of 1.62 % testosterone gel after daily application to the skin of hypogonadal men for 182 days . METHODS This was a multicenter , r and omized , double-blind , placebo-controlled study in hypogonadal men ( 234 active ; 40 placebo ) , 18 to 80 years of age with average serum total testosterone concentrations Topical testosterone gel ( 1.62 % ) , 1.25 g , 2.5 g , 3.75 g , and 5.0 g , or placebo gel was applied once daily to either upper arms/shoulders or abdomen . Dose adjustments were made on days 14 , 28 , and 42 . Main Outcome Measures . The percentage of subjects with serum total testosterone average concentrations ( C(av ) ) within the normal range of 300 - 1,000 ng/dL on study days 14 , 56 , 112 , and 182 . RESULTS Following titration , significantly ( P testosterone C(av ) values ( range 81.6 % to 82.5 % ) within the eugonadal range compared with placebo ( range 28.6 % to 37.0 % ) on all study days . The 1.62 % gel was safe and well tolerated . CONCLUSIONS In this study , treatment with 1.62 % testosterone gel was safe and efficacious , result ing in an acceptable percentage of hypogonadal males achieving eugonadal serum testosterone levels",
"High quality r and omised trials provide unbiased estimates of the effects of health interventions , but the findings of a single trial are rarely conclusive . Usually data from several similar trials must be pooled together to draw firm conclusions about the effectiveness of an intervention . This article considers how to determine whether data from existing trials are conclusive and , if not , whether a further trial is justified .",
"As men age , their serum testosterone concentrations decrease , as do their bone densities . Because bone density is also low in hypogonadal men , we hypothesized that increasing the serum testosterone concentrations of men over 65 yr to those found in young men would increase their bone densities . We r and omized 108 men over 65 yr of age to wear either a testosterone patch or a placebo patch double blindly for 36 months . We measured bone mineral density by dual energy x-ray absorptiometry before and during treatment . Ninety-six men completed the entire 36-month protocol . The mean serum testosterone concentration in the men treated with testosterone increased from 367 + /- 79 ng/dL ( + /-SD ; 12.7 + /- 2.7 nmol/L ) before treatment to 625 + /- 249 ng/dL ( 21.7 + /- 8.6 nmol/L ; P mean bone mineral density of the lumbar spine increased ( P placebo-treated ( 2.5 + /- 0.6 % ) and testosterone-treated ( 4.2 + /- 0.8 % ) groups , but the mean changes did not differ between the groups . Linear regression analysis , however , demonstrated that the lower the pretreatment serum testosterone concentration , the greater the effect of testosterone treatment on lumbar spine bone density from 0 - 36 months ( P = 0.02 ) . This analysis showed a minimal effect ( 0.9 + /- 1.0 % ) of testosterone treatment on bone mineral density for a pretreatment serum testosterone concentration of 400 ng/dL ( 13.9 nmol/L ) , but an increase of 5.9 + /- 2.2 % for a pretreatment testosterone concentration of 200 ng/dL ( 6.9 nmol/L ) . Increasing the serum testosterone concentrations of normal men over 65 yr of age to the midnormal range for young men did not increase lumbar spine bone density overall , but did increase it in those men with low pretreatment serum testosterone concentrations",
"Background Experimental studies suggest that and rogens induce coronary vasodilatation . We performed this pilot project to examine the clinical effects of long-term low-dose and rogens in men with angina . Methods and Results Forty-six men with stable angina completed a 2-week , single-blind placebo run-in , followed by double-blind r and omization to 5 mg testosterone daily by transdermal patch or matching placebo for 12 weeks , in addition to their current medication . Time to 1-mm ST-segment depression on treadmill exercise testing and hormone levels were measured and quality of life was assessed by SF-36 at baseline and after 4 and 12 weeks of treatment . Active treatment result ed in a 2-fold increase in and rogen levels and an increase in time to 1-mm ST-segment depression from ( mean±SEM ) 309±27 seconds at baseline to 343±26 seconds after 4 weeks and to 361±22 seconds after 12 weeks . This change was statistically significant compared with that seen in the placebo group ( from 266±25 seconds at baseline to 284±23 seconds after 4 weeks and to 292±24 seconds after 12 weeks;P = 0.02 between the 2 groups by ANCOVA ) . The magnitude of the response was greater in those with lower baseline levels of bioavailable testosterone ( r = −0.455 , P changes in prostate specific antigen , hemoglobin , lipids , or coagulation profiles during the study . There were significant improvements in pain perception ( P = 0.026 ) and role limitation result ing from physical problems ( P = 0.024 ) in the testosterone-treated group . Conclusions Low-dose supplemental testosterone treatment in men with chronic stable angina reduces exercise-induced myocardial ischemia ",
"BACKGROUND Many men older than 50 years have bioavailable testosterone levels below the reference range for young adult men . The impact of the decreased and rogen levels on cognition and health perception has received little attention . METHODS Sixty-seven men ( mean age 76 + /- 4 years , range 65 - 87 ) with bioavailable testosterone levels below 128 ng/dl ( lower limit for adult normal range ) were r and omized to receive transdermal testosterone ( 2 - 2.5 mg patches/d ) or placebo patches for 1 year . All men received 500 mg supplemental calcium and 400 IU vitamin D. Outcome measures included sex hormones [ testosterone , bioavailable testosterone , sex hormone binding globulin ( SHBG ) , estradiol , and estrone ] , cognitive tests ( Digit Symbol , Digit Span , Trailmaking A and B ) , health perception ( Medical Outcome Survey Short-form 36 or SF-36 ) , lower extremity muscle strength and power , and calcium intake . RESULTS Twenty-three men ( 34 % ) withdrew from the study ; 44 men completed the trial . Bioavailable testosterone levels increased from 93 + /- 34 ( SD ) to 162 + /- 100 ng/dl ( p estradiol levels in either group , estrone levels increased in the testosterone group ( 28 + /- 7 to 32 + /- 9 pg/dl , p = .017 ) . Scores on the Digit Symbol test improved in both the testosterone and placebo groups . Scores on Trailmaking B improved in men treated with testosterone ( p Trailmaking B for the entire group were correlated with 12-month testosterone levels ( p = .016 ) . Scores for health perception measured by SF-36 did not change significantly , though scores of mental and general health declined in both groups during the 12-month intervention . Twelve-month bioavailable testosterone scores were directly correlated with scores for physical role ( p = .022 ) , vitality ( p = .036 ) , and the physical composite score ( p = .010 ) . CONCLUSIONS Transdermal testosterone treatment in men with low bioavailable testosterone levels does not impair and may improve cognitive function . Treatment did not improve health perception but this may have been due to the side effects of skin irritation suggested by similar reactions in both the testosterone and placebo groups",
"Thirty-five male patients , aged 34 - 79 yr , with definite rheumatoid arthritis ( RA ) were recruited from out-patient clinics and r and omized to receive monthly injections of testosterone enanthate 250 mg or placebo as an adjunct therapy for 9 months . Endpoints included disease activity parameters and bone mineral density ( BMD ) . At baseline , there were negative correlations between the ESR and serum testosterone ( r = -0.42 , P BMD ( hip , r = -0.65 , P vertebral fracture , most having multiple fractures . Back pain , however , was not more prevalent in fracture patients ( 55 % vs 50 % ) . Disease activity was significantly higher in the fracture group ( joint score P Thirty patients completed the trial , 15 receiving testosterone and 15 receiving placebo . There were significant rises in serum testosterone , dihydrotestosterone and oestradiol in the treatment group . There was no significant effect of treatment on disease activity overall , five patients receiving testosterone underwent a \" flare ' . Differences in mean BMD following testosterone or placebo were non-significant ( spine : + 1.2 % vs -1.1 % ; femur : -0.3 % vs + 0.3 % ) . There was no suggestion of a positive effect of testosterone on disease activity in men with RA",
"BACKGROUND Sex hormones are known to affect cholesterol levels and vascular tone in women . The effects of testosterone on cholesterol and vascular tone in men are less well understood . Low testosterone levels have been associated with higher cholesterol levels in epidemiologic studies , but testosterone replacement has result ed in variable changes in cholesterol levels . Similarly , clinical studies suggest that testosterone may be vasodilatory , but few studies have directly evaluated the effects of testosterone on vascular tone . METHODS Sixty-seven men ( mean age 76 + /- 4 years , range 65 - 87 ) with bioavailable testosterone levels below 4.44 nmol/l ( lower limit for adult normal range ) were r and omized to receive transdermal testosterone ( 2 - 2.5 mg patches/d ) or placebo patches for 1 year . Twenty-three men ( 34 % ) withdrew from the study ; 44 men completed the trial . RESULTS While total cholesterol , triglyceride , and low-density lipoprotein cholesterol levels did not significantly change during the year of therapy , high-density lipoprotein ( HDL ) levels ( p = .004 ) and , specifically , HDL(2 ) subfraction ( p = .02 ) decreased in men receiving testosterone supplementation . Vascular tone was measured by brachial artery reactivity in 36 men . Endothelium-dependent brachial artery reactivity did not change from baseline measurements in men receiving transdermal testosterone ( 0.3 + /- 6.7 % to 1.6 + /- 4.6 % ; p = .58 ) or in the placebo group ( 3.2 + /- 5.5 % to 0.7 + /- 5.5 % ; p = .23 ) . CONCLUSIONS Transdermal testosterone decreased HDL(2 ) cholesterol but did not affect vascular reactivity in men older than 65 years selected for low testosterone levels . No study to date has addressed the direct relationship between testosterone replacement and cardiovascular events",
"BACKGROUND Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men . The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied . METHODS Community-dwelling men , 65 years of age or older , with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter ( 3.5 to 12.1 nmol per liter ) or a free serum testosterone level of less than 50 pg per milliliter ( 173 pmol per liter ) were r and omly assigned to receive placebo gel or testosterone gel , to be applied daily for 6 months . Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification . The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group . RESULTS A total of 209 men ( mean age , 74 years ) were enrolled at the time the trial was terminated . At baseline , there was a high prevalence of hypertension , diabetes , hyperlipidemia , and obesity among the participants . During the course of the study , the testosterone group had higher rates of cardiac , respiratory , and dermatologic events than did the placebo group . A total of 23 subjects in the testosterone group , as compared with 5 in the placebo group , had cardiovascular-related adverse events . The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period . As compared with the placebo group , the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load . CONCLUSIONS In this population of older men with limitations in mobility and a high prevalence of chronic disease , the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events . The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy . ( Clinical Trials.gov number , NCT00240981 .",
"AIMS Chronic heart failure is associated with maladaptive and prolonged neurohormonal and pro-inflammatory cytokine activation causing a metabolic shift favouring catabolism , vasodilator incapacity , and loss of skeletal muscle bulk and function . In men , and rogens are important determinants of anabolic function and physical strength and also possess anti-inflammatory and vasodilatory properties . METHODS AND RESULTS We conducted a r and omized , double-blind , placebo-controlled parallel trial of testosterone replacement therapy ( 5 mg And roderm ) at physiological doses in 76 men ( mean+/-SD , age 64+/-9.9 ) with heart failure ( ejection fraction 32.5+/-11 % ) over a maximum follow-up period of 12 months . The primary endpoint was functional capacity as assessed by the incremental shuttle walk test ( ISWT ) . At baseline , 18 ( 24 % ) had serum testosterone below the normal range and bioavailable testosterone correlated with distance walked on the initial ISWT ( r=0.3 , P=0.01 ) . Exercise capacity significantly improved with testosterone therapy compared with placebo over the full study period ( mean change + 25+/-15 m ) corresponding to a 15+/-11 % improvement from baseline ( P=0.006 ANOVA ) . Symptoms improved by at least one functional class on testosterone in 13 ( 35 % ) vs. 3 ( 8 % ) on placebo ( P=0.01 ) . No significant changes were found in h and grip strength , skeletal muscle bulk by cross-sectional computed tomography , or in tumour necrosis factor levels . Testosterone therapy was safe with no excess of adverse events although the patch preparation was not well tolerated by the study patients . CONCLUSION Testosterone replacement therapy improves functional capacity and symptoms in men with moderately severe heart failure",
"Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists",
"PURPOSE Determine the independent and combined effects of progressive resistance muscle strength training ( PRMST ) and testosterone on strength , muscle mass , and function in hypogonadal elderly male recuperative care patients . METHODS Between 1999 and 2004 , 71 subjects ( mean age 78.2 + /- 6.4 yr , 86 % white ) were enrolled . After baseline one-repetition maximum ( 1RM ) strength testing and then r and omization to one of four treatment groups ( low-resistance ( 20 % of the 1RM ) exercises and weekly injections of either 100 mg of testosterone enanthate or placebo or high-intensity PRMST ( > or = 80 % 1RM ) and weekly injections ) , each subject received training and injections for 12 wk . RESULTS Ten subjects withdrew from the study before its completion . Based on intent-to-treat analyses , strength improved in all groups , but was greater with high-intensity PRMST compared with low-resistance exercise ( e.g. , leg press , ( mean + /- SE ) , 28 + /- 4 vs 13 + /- 4 % , P = 0.009 ) . Although testosterone led to significantly greater increases in midthigh cross-sectional muscle area compared with placebo ( 7.9 + /- 1.3 vs 2.4 + /- 1.4 % , P = 0.005 ) , it produced only a nonsignificant trend toward greater strength gains ( e.g. , leg press 25 + /- 4 vs 16 + /- 4 % , P = 0.144 ) . Change in aggregate functional performance score ( the sum of 4 functional performance test scores ) did not differ between the four intervention groups nor with high-intensity PRMST compared with low-resistance exercise ( 7 + /- 5 vs 15 + /- 5 % , P = 0.263 ) . There was not a significant interaction between exercise and testosterone for any outcome . CONCLUSION High-intensity PRMST is as safe and well tolerated as a similarly structured low-resistance exercise regimen for very frail elderly patients , but produces greater muscle strength improvements . The addition of testosterone leads to greater muscle size and a trend toward greater strength but did not produce a synergistic interaction with exercise . Neither intervention had a significant effect on functional performance",
"Clinical studies suggest there may be a threshold concentration of serum testosterone below which replacement will result in skeletal and psychological benefit . We evaluated the response to testosterone in men with borderline hypogonadism . A r and omized double-blind placebo-controlled trial in 39 men over age 40 years presenting with sexual dysfunction and a borderline low testosterone level ( total testosterone Patients were r and omized to Testoderm TTS body patch ( 5 mg/day , n = 20 ) or a placebo patch ( n = 19 ) for 6 months , followed by open-label testosterone replacement for a further 6 months in all patients . During the placebo-controlled phase of the study serum testosterone increased significantly on testosterone vs. placebo treatment ( p = 0.004 ) ; this was associated with a decrease in total body fat mass ( p = 0.019 ) and increase in haemoglobin level ( p = 0.036 ) . There were no significant changes in lean body mass , markers of bone turnover , and measures of bone mineral density ( BMD ) . There was evidence of difference in quality of life according to the Male Erectile Dysfunction Quality of Life question naire ( MEDQoL score , p = 0.017 ) , mainly accounted for by deterioration in the placebo arm . When the active treatment period was combined for placebo and testosterone groups , the within-patient analysis showed a significant effect of testosterone to decrease markers of bone resorption ( uNTX/Cr , p = 0.007 ; iFDPD/Cr , p = 0.0006 ) and to increase lean body mass ( p = 0.001 ) . There was little convincing evidence from this study that testosterone replacement is likely to have major benefit in men over age 40 years with borderline hypogonadism and sexual dysfunction . However , there was evidence of suppression in bone resorption and hence longer and larger studies are needed to examine its effect on BMD",
"BACKGROUND Reports of clinical trials usually emphasize efficacy results , especially when results are statistically significant . Poor safety reporting can lead to misinterpretation and inadequate conclusions about the interventions assessed . Our aim was to describe the reporting of harm-related results from r and omized controlled trials ( RCTs ) . METHODS We search ed the MEDLINE data base for reports of RCTs published from January 1 , 2006 , through January 1 , 2007 , in 6 general medical journals with a high impact factor . Data were extracted by use of a st and ardized form to appraise the presentation of safety results in text and tables . RESULTS Adverse events were mentioned in 88.7 % of the 133 reports . No information on severe adverse events and withdrawal of patients owing to an adverse event was given in 27.1 % and 47.4 % of articles , respectively . Restrictions in the reporting of harm-related data were noted in 43 articles ( 32.3 % ) with a description of the most common adverse events only ( n = 17 ) , severe adverse events only ( n = 16 ) , statistically significant events only ( n = 5 ) , and a combination of restrictions ( n = 5 ) . The population considered for safety analysis was clearly reported in 65.6 % of articles . CONCLUSION Our review reveals important heterogeneity and variability in the reporting of harm-related results in publications of RCTs",
"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",
"BACKGROUND The role of sex hormones in the prevention of cognitive decline is uncertain . Animal studies suggest mechanisms for sex hormones including testosterone to maintain optimal cognitive function . But , there are studies to suggest that endogenous testosterone levels are associated with aggression in men with cognitive impairment . METHODS In this pilot study , 11 men ( mean age 80 + /- 5 years , range 73 - 87 years ) with early cognitive decline and bioavailable testosterone levels below 128 ng/dl ( lower limit for adult normal range ) were r and omized to receive intramuscular testosterone ( 200 mg every 3 weeks ) or placebo for 12 weeks . Outcome measures included sex hormones ( testosterone , bioavailable testosterone , sex hormone binding globulin , estradiol , and estrone ) , Behave AD Question naire , Katz Activities of Daily Living , Geriatric Depression Scale , Digit Span , Clock Face Drawing , Clock Face Perception , Verbal Fluency , Trail-Making B , and International Prostate Symptom Score at baseline , 4 weeks , and 10 weeks . RESULTS All men completed the study . Total and bioavailable testosterone , estrone , and estradiol levels increased in men receiving testosterone , but no changes were detected in men receiving placebo . No significant changes were found in behavior following testosterone supplementation , nor was there evidence of change in depression or activities of daily living . No discernable changes were found in any of the cognitive tests . Symptoms of prostate hyperplasia remained unchanged in the testosterone ( 6.6 + 5.8 to 5.2 + 3.6 ; p = .39 ) and placebo ( 8.8 + 6.4 to 6.4 + 3.8 ; p = .15 ) groups , and prostate-specific antigen levels did not change significantly . CONCLUSION No significant changes in behavior , function , depression , or cognitive performance occurred following 12 weeks of testosterone replacement in men with low testosterone levels and early-to-moderate cognitive impairment . This pilot work suggests that testosterone can be given to men with early cognitive impairment without significant concern about worsening aggressive or unwanted behaviors",
"Studies on regional differences of adipose tissue metabolism have mainly been performed in vitro . To allow measurements of lipid uptake in vivo in man , radioactive label from [9,10 - 3H]oleic acid in 80 g orally administered milk fat was measured after 4 h in abdominal and femoral sc adipose tissues in 28 middle-aged , abdominally obese men . Radioactivity was measured in adipose tissue triglycerides extracted from needle biopsies . Lipoprotein lipase ( LPL ) activity was also measured . Uptake of label in triglycerides and LPL activity were higher ( 20 % and 15 % , respectively ; P testosterone ( T ) , dihydrotestosterone , or placebo , for 9 months . After 2 months of treatment , the procedure of administration of label was repeated , this time using [U-14C]oleic acid as a marker . Measurements of radioactive label was then performed after 4 h and monthly up to 7 months . Supplementation with T was followed by an inhibited uptake of label in triglycerides ( 34 % ; P LPL activity ( 48 % ; P shorter t1/2 ( 30 % ; P triglyceride uptake , LPL activity , or t1/2 was found in sc femoral adipose tissue . It was concluded that the turnover rate of depot triglycerides is more rapid in abdominal compared to femoral sc adipose tissue in men . Furthermore , T supplementation inhibits triglyceride uptake and LPL activity and causes a more rapid turnover of triglycerides only in the sc abdominal adipose tissue region . These results demonstrate the marked effects of T on adipose tissue metabolism in vivo and suggest that T is an important regulator of the proportion of depot fat mass in central and peripheral adipose tissue in men",
"The objective of the study was to investigate the effects of dihydrotestosterone ( DHT ) gel on general well-being , sexual function , and the prostate in aging men . A total of 120 men participated in this r and omized , placebo-controlled study ( 60 DHT and 60 placebo ) . All subjects had nocturnal penile tumescence once per week or less , and ropause symptoms , and a serum T level of 15 nmol/liter or less and /or a serum SHBG level greater than 30 nmol/liter . The mean age was 58 yr ( range , 50 - 70 yr ) . Of these subjects , 114 men completed the study . DHT was administered transdermally for 6 months , and the dose varied from 125 - 250 mg/d . General well-being symptoms and sexual function were evaluated using a question naire , and prostate symptoms were evaluated using the International Prostate Symptoms Score , transrectal ultrasonography , and assay of serum prostate-specific antigen . Early morning erections improved transiently in the DHT group at 3 months of treatment ( P ability to maintain erection improved in the DHT group compared with the placebo group ( P general well-being between the placebo and the DHT group . Serum concentrations of LH , FSH , E2 , T , and SHBG decreased significantly during DHT treatment . Treatment with DHT did not affect liver function or the lipid profile . Hemoglobin concentrations increased from 146.0 + /- 8.2 to 154.8 + /- 11.4 g/liter , and hematocrit from 43.5 + /- 2.5 % to 45.8 + /- 3.4 % ( P Prostate weight and prostate-specific antigen levels did not change during the treatment . No major adverse events were observed . Transdermal administration of DHT improves sexual function and may be a useful alternative for and rogen replacement . As estrogens are thought to play a role in the pathogenesis of prostate hyperplasia , DHT may be beneficial , compared with aromatizing and rogens , in the treatment of aging men",
"BACKGROUND Hypogonadism and anemia are common comorbid conditions in dialysis patients . Testosterone replacement may improve such clinical parameters as anemia , sarcopenia , and low libido . Additionally , by increasing hemoglobin levels , testosterone replacement may allow for a dose reduction in recombinant human erythropoietin ( rHuEPO ) , thereby reducing cost . METHODS This phase IV , single-center , placebo-controlled , double-blind study assessed the effect of transdermal testosterone on serum testosterone levels , rHuEPO dose required to maintain hemoglobin level , bone mineral content , lean body mass and fat content , cholesterol level , sexual function , and mood . Forty hypogonadal male hemodialysis patients who were administered rHuEPO were r and omly assigned to 100 mg of topical 1 % testosterone gel ( Testim ; Auxilium Pharmaceuticals , Norristown , PA ) or placebo , applied daily for 6 months . RESULTS Forty men with a mean age of 56 years and baseline serum testosterone level less than 300 ng/dL ( In men assigned to administration of transdermal testosterone , there was an increase beyond that in the placebo group in mean serum testosterone ( 77.1 ng/dL [ 2.7 nmol/L ] ) , dihydrotestosterone ( DHT ; 0.8 nmol/L ) , and estradiol levels ( 6.3 pg/mL [ 23.0 pmol/L ] ) and a decrease in mean serum luteinizing hormone levels ( -3.1 IU/L ) . Compared with subjects administered placebo , participants on testosterone replacement therapy did not show an appreciable change in rHuEPO dose ( mean difference adjusted for baseline values , 12.6 U/kg/wk ; P = 0.73 ) , bone mineral density , lean body mass or fat content , cholesterol level , sexual function , or mood . CONCLUSION Daily administration of 100 mg of topical 1 % testosterone gel for 6 months failed to significantly increase serum testosterone or DHT levels in hypogonadal men with end-stage renal disease . Treatment with transdermal testosterone did not impact on rHuEPO requirement or clinical parameters in this small placebo-controlled study . Greater serum testosterone levels may be required to show clinical benefit in men with end-stage renal disease",
"As men age , serum testosterone concentrations decrease , the percentage of body mass that is fat increases , the percentage of lean body mass decreases , and muscle strength decreases . Because these changes are similar to those that occur in hypogonadal men , we hypothesized that increasing the serum testosterone concentration of men over 65 yr of age to that in young men would decrease their fat mass , increase their lean mass , and increase their muscle strength . We r and omized 108 men over 65 yr of age to wear either a testosterone patch or a placebo patch in a double blind study for 36 months . We measured body composition by dual energy x-ray absorptiometry and muscle strength by dynamometer before and during treatment . Ninety-six men completed the entire 36-month protocol . Fat mass decreased ( -3.0+/-0.5 kg ) in the testosterone-treated men during the 36 months of treatment , which was significantly different ( P = 0.001 ) from the decrease ( -0.7+/-0.5 kg ) in the placebo-treated men . Lean mass increased ( 1.9+/-0.3 kg ) in the testosterone-treated men , which was significantly different ( P decrease in fat mass in the testosterone-treated men was principally in the arms ( -0.7+/-0.1 kg ; P lean mass was principally in the trunk ( 1.9+/-0.3 kg ; P strength of knee extension and flexion at 60 degrees and 180 degrees angular velocity during treatment , however , was not significantly different between the two groups . We conclude that increasing the serum testosterone concentrations of normal men over 65 yr of age to the midnormal range for young men decreased fat mass , principally in the arms and legs , and increased lean mass , principally in the trunk , but did not increase the strength of knee extension and flexion , as measured by dynamometer",
"A decline in testicular function is recognized as a common occurrence in older men . However data are sparse regarding the effects of hypogonadism on age-associated physical and cognitive declines . This study was undertaken to examine the year-long effects of testosterone administration in this patient population . Fifteen hypogonadal men ( mean age 68 + /- 6 yr ) were r and omly assigned to receive a placebo , and 17 hypogonadal men ( mean age 65 + /- 7 yr ) were r and omly assigned to receive testosterone . Hypogonadism was defined as a bioavailable testosterone placebo or 200 mg testosterone cypionate biweekly for 12 months . The main outcomes measured included grip strength , hemoglobin , prostate-specific antigen , leptin , and memory . Testosterone improved bilateral grip strength ( P hemoglobin ( P testosterone had greater decreases in leptin than those assigned to the control group ( mean + /- SEM : -2.0 + /- 0.9 ng/dL vs. 0.8 + /- 0.7 ng/dL ; P prostate-specific antigen or memory . Three subjects receiving placebo and seven subjects receiving testosterone withdrew from the study . Three of those seven withdrew because of an abnormal elevation in hematocrit . Testosterone supplementation improved strength , increased hemoglobin , and lowered leptin levels in older hypogonadal men . Testosterone may have a role in the treatment of frailty in males with hypogonadism ; however , older men receiving testosterone must be carefully monitored because of its potential risks",
"CONTEXT Physical frailty is associated with reduced muscle strength , impaired physical function , and quality of life . Testosterone ( T ) increases muscle mass and strength in hypogonadal patients . It is unclear whether T has similar effects in intermediate-frail and frail elderly men with low to borderline-low T. OBJECTIVE Our objective was to determine the effects of 6 months T treatment in intermediate-frail and frail elderly men , on muscle mass and strength , physical function , and quality of life . DESIGN AND SETTING We conducted a r and omized , double-blind , placebo-controlled , parallel-group , single-center study . PARTICIPANTS PARTICIPANTS were community-dwelling intermediate-frail and frail elderly men at least 65 yr of age with a total T at or below 12 nmol/liter or free T at or below 250 pmol/liter . METHODS Two hundred seventy-four participants were r and omized to transdermal T ( 50 mg/d ) or placebo gel for 6 months . Outcome measures included muscle strength , lean and fat mass , physical function , and self-reported quality of life . RESULTS Isometric knee extension peak torque improved in the T group ( vs. placebo at 6 months ) , adjusted difference was 8.6 ( 95 % confidence interval , 1.3 - 16.0 ; P = 0.02 ) Newton-meters . Lean body mass increased and fat mass decreased significantly in the T group by 1.08 + /- 1.8 and 0.9 + /- 1.6 kg , respectively . Physical function improved among older and frailer men . Somatic and sexual symptom scores decreased with T treatment ; adjusted difference was -1.2 ( -2.4 to -0.04 ) and -1.3 ( -2.5 to -0.2 ) , respectively . CONCLUSIONS T treatment in intermediate-frail and frail elderly men with low to borderline-low T for 6 months may prevent age-associated loss of lower limb muscle strength and improve body composition , quality of life , and physical function . Further investigations are warranted to extend these results",
"PURPOSE Because the effects of and rogen replacement on lipoprotein levels are uncertain , we sought to determine the effect of transdermal testosterone treatment on serum lipid and apolipoprotein levels in elderly men . SUBJECTS AND METHODS One hundred and eight healthy men more than 65 years of age who had serum testosterone concentrations > 1 SD below the mean for young men were r and omly assigned to receive either testosterone ( 54 men ; 6 mg/day ) or placebo ( 54 men ) transdermally in a double-blind fashion for 36 months . Serum concentrations of lipids and apolipoproteins were measured , and cardiovascular events recorded . RESULTS Serum total cholesterol concentrations decreased in both the testosterone-treated men and placebo-treated men , but the 3-year mean ( + /- SD ) decreases in the two groups ( testosterone treated , -17 + /- 29 mg/dL ; placebo treated , -12 + /- 38 mg/dL ) were not significantly different from each other ( P = 0.4 ) . Similarly , serum low-density lipoprotein ( LDL ) cholesterol levels decreased in both treatment groups , but the decreases in the two groups ( testosterone treated , -16 + /- 24 mg/dL ; placebo treated , -16 + /- 33 mg/dL ) were similar ( P = 1.0 ) . Levels of high-density lipoprotein ( HDL ) cholesterol , triglycerides , and apolipoproteins A-I and B did not change . Lipoprotein(a ) levels increased in both groups by similar amounts ( testosterone treated , 3 + /- 9 mg/dL ; placebo treated , 4 + /- 6 mg/dL ; P = 1.0 ) . The number of cardiovascular events was small and did not differ significantly between the testosterone-treated men ( 9 events ) and the placebo-treated men ( 5 events ) during the 3-year study ( relative risk = 1.8 ; 95 % confidence interval : 0.7 to 5.0 ) . CONCLUSIONS As compared with placebo , transdermal testosterone treatment of healthy elderly men for 3 years did not affect any of the lipid or apolipoprotein parameters that we measured . The effect of testosterone treatment on cardiovascular events was unclear , because the number of events was small",
"In 1991 , Stampfer and Colditz , 1 review ing epidemiological studies of the effect of postmenopausal oestrogen on coronary heart disease concluded that : ‘ … the bulk of evidence strongly supports a protective effect of estrogens that is unlikely to be explained by confounding factors … ’ Their best estimate of the relative risk of coronary heart disease ( CHD ) in postmenopausal oestrogen users was calculated using meta-analytical techniques applied to the epidemiological studies they deemed to be of high quality based on their design s— prospect i ve studies with internal controls and angiographic studies . This estimate was 0.50 . The CI was narrow � 0.43 to 0.56",
"A double-blind , placebo-controlled multicenter trial was conducted to determine the efficacy of oral testosterone treatment ( 200 mg three times daily ) in men with alcoholic cirrhosis . By skewed r and omization ( 3:2 ) , 134 patients received testosterone and 87 placebo . Patients were followed from 8 to 62 months ( median = 28 months ) . In the testosterone group , 33 patients died ( 25 % ; 95 % confidence limits = 18 to 33 % ) as compared to 18 ( 21 % ; 95 % confidence limits = 13 to 31 % ) in the placebo group . Taking age and significant prognostic variables into consideration , this corresponds with a relative mortality risk of 1.17 ( 95 % confidence limits = 0.65 to 2.15 ) in the testosterone group vs. the placebo group . Testosterone treatment did not significantly affect liver biochemistry , prevalence of complications to cirrhosis or causes of death . Patients treated with testosterone developed significantly ( p less than 0.05 ) higher serum testosterone and blood hemoglobin concentrations and significantly ( p less than 0.05 ) lower plasma IgM concentrations as compared to the placebo group . The prevalence of gynecomastia decreased significantly ( p less than 0.05 ) in the testosterone group as compared to the placebo group . We conclude that oral testosterone treatment has no beneficial effect on survival and liver biochemistry in men with alcoholic cirrhosis , and adverse effects can not be excluded",
"Objective To explore why reports that seem to describe r and omised controlled trials are sometimes not indexed ( “ tagged ” ) with RCT ( r and omised controlled trial ) [ pt ] ( publication type ) in Medline . Design Cross sectional study . Setting The Cochrane Collaboration and US National Library of Medicine worked together to identify and retag records of r and omised controlled trials with RCT [ pt ] , 1994 to 2006 . Data source Published reports entered into Medline in 2005 . Main outcome measures Type of trial information presented ( for example , main results , design , and methods ) , trial design , and other Medline indexing terms applied . Results 572/591 ( 97 % ) untagged records and 578/594 ( 97 % ) tagged records contained information from r and omised controlled trials . Type of trial information and design differed between untagged and tagged reports . Fewer than half ( 234/572 , 41 % , 95 % confidence interval 37 % to 45 % ) of untagged reports but most tagged reports ( 526/578 , 91 % , 89 % to 93 % ) described the main results of the trial . Untagged reports were more likely than tagged reports to contain information on design and methods , baseline characteristics , long term follow-up , and secondary analyses . Untagged reports of main results were more likely than tagged reports to be from trials using a crossover design ( 36 % v 10 % , difference 25 % , 95 % confidence interval 19 % to 32 % ) . The Medical Subject Heading “ R and omized Controlled Trials ” was the most common clinical trial term applied to untagged reports , although more than half of untagged reports had no indexing related to trials . Conclusion Based on the results for 2005 , at least 3000 records describing r and omised controlled trials but not indexed using RCT [ pt ] may have been entered into Medline between 2006 and 2011 . Research ers and healthcare decision makers relying on using RCT [ pt ] may be missing important evidence in their search es , particularly for design and methods , baseline characteristics , long term follow-up , and secondary data analyses",
"BACKGROUND Dehydroepi and rosterone ( DHEA ) and testosterone are widely promoted as antiaging supplements , but the long-term benefits , as compared with potential harm , are unknown . METHODS We performed a 2-year , placebo-controlled , r and omized , double-blind study involving 87 elderly men with low levels of the sulfated form of DHEA and bioavailable testosterone and 57 elderly women with low levels of sulfated DHEA . Among the men , 29 received DHEA , 27 received testosterone , and 31 received placebo . Among the women , 27 received DHEA and 30 received placebo . Outcome measures included physical performance , body composition , bone mineral density ( BMD ) , glucose tolerance , and quality of life . RESULTS As compared with the change from baseline to 24 months in the placebo group , subjects who received DHEA for 2 years had an increase in plasma levels of sulfated DHEA by a median of 3.4 microg per milliliter ( 9.2 micromol per liter ) in men and by 3.8 microg per milliliter ( 10.3 micromol per liter ) in women . Among men who received testosterone , the level of bioavailable testosterone increased by a median of 30.4 ng per deciliter ( 1.1 nmol per liter ) , as compared with the change in the placebo group . A separate analysis of men and women showed no significant effect of DHEA on body-composition measurements . Neither hormone altered the peak volume of oxygen consumed per minute , muscle strength , or insulin sensitivity . Men who received testosterone had a slight increase in fat-free mass , and men in both treatment groups had an increase in BMD at the femoral neck . Women who received DHEA had an increase in BMD at the ultradistal radius . Neither treatment improved the quality of life or had major adverse effects . CONCLUSIONS Neither DHEA nor low-dose testosterone replacement in elderly people has physiologically relevant beneficial effects on body composition , physical performance , insulin sensitivity , or quality of life . ( Clinical Trials.gov number , NCT00254371 [ Clinical Trials.gov ] . )",
"The efficacy and safety of and rogen supplementation in older men remains controversial . Despite biochemical evidence of partial and rogen deficiency in older men , controlled studies using T demonstrate equivocal benefits . Furthermore , the importance of aromatization and 5alpha reduction in and rogen actions among older men remains unclear . Dihydrotestosterone is the highest potency natural and rogen with the additional features that it is neither aromatizable nor susceptible to potency amplification by 5alpha reduction . Therefore , the effects of dihydrotestosterone may differ from those of T in older men . This study evaluated the efficacy and safety of 3 months treatment with transdermal dihydrotestosterone gel on muscle strength , mobility , and quality of life in ambulant , community-dwelling men aged 60 yr or older . Eligible men ( plasma T were r and omized to undergo daily dermal application of 70 mg dihydrotestosterone gel ( n = 18 ) or vehicle ( n = 19 ) and were studied before , monthly during , and 1 month after treatment . Among 33 ( 17 dihydrotestosterone , 16 placebo ) men completing the study with a high degree of compliance , dihydrotestosterone had significant effects on circulating hormones ( increased dihydrotestosterone ; decreased total and free testosterone , LH , and FSH ; unchanged SHBG and estradiol ) , lipid profiles ( decreased total and low-density lipoprotein cholesterols ; unchanged high-density lipoprotein cholesterol and triglycerides ) , hematopoiesis ( increased hemoglobin , hematocrit , and red cell counts ) , and body composition ( decreased skinfold thickness and fat mass ; unchanged lean mass and waist to hip ratio ) . Muscle strength measured by isokinetic peak torque was increased in flexion of the dominant knee but not in knee extension or shoulder contraction , nor was there any significant change in gait , balance , or mobility tests , in cognitive function , or in quality of life scales . Dihydrotestosterone treatment had no adverse effects on prostate ( unchanged prostate volumes and prostate-specific antigen ) and cardiovascular ( no adverse change in vascular reactivity or lipids ) safety markers . We conclude that 3 months treatment with transdermal dihydrotestosterone gel demonstrates expected and rogenic effects , short-term safety , and limited improvement in lower limb muscle strength but no change in physical functioning or cognitive function",
"OBJECTIVES This study investigated the effect of a 12-week long-acting testosterone administration on maximal exercise capacity , ventilatory efficiency , muscle strength , insulin resistance , and baroreflex sensitivity ( BRS ) in elderly patients with chronic heart failure ( CHF ) . BACKGROUND CHF is characterized by a metabolic shift favoring catabolism and impairment in skeletal muscle bulk and function that could be involved in the pathophysiology of heart failure . METHODS Seventy elderly patients with stable CHF-median age 70 years , ejection fraction 31.8 + /- 7%-were r and omly assigned to receive testosterone ( n = 35 , intramuscular injection every 6 weeks ) or placebo ( n = 35 ) , both on top of optimal medical therapy . At baseline and at the end of the study , all patients underwent echocardiogram , cardiopulmonary exercise test , 6-min walk test ( 6MWT ) , quadriceps maximal voluntary contraction ( MVC ) , and isokinetic strength ( peak torque ) and BRS assessment ( sequences technique ) . RESULTS Baseline peak oxygen consumption ( VO(2 ) ) and quadriceps isometric strength showed a direct relation with serum testosterone concentration . Peak VO(2 ) significantly improved in testosterone but was unchanged in placebo . Insulin sensitivity was significantly improved in testosterone . The MVC and peak torque significantly increased in testosterone but not in placebo . The BRS significantly improved in testosterone but not in placebo . Increase in testosterone levels was significantly related to improvement in peak VO(2 ) and MVC . There were no significant changes in left ventricular function either in testosterone or placebo . CONCLUSIONS These results suggest that long-acting testosterone therapy improves exercise capacity , muscle strength , glucose metabolism , and BRS in men with moderately severe CHF . Testosterone benefits seem to be mediated by metabolic and peripheral effects",
"OBJECTIVES To investigate the effects of testosterone supplementation on bone , body composition , muscle , physical function , and safety in older men . DESIGN Double-blind , r and omized , placebo-controlled trial . SETTING A major medical institution . PARTICIPANTS One hundred thirty-one men ( mean age 77.1 + /- 7.6 ) with low testosterone , history of fracture , or bone mineral density ( BMD ) T-score less than -2.0 and frailty . INTERVENTION Participants received 5 mg/d of testosterone or placebo for 12 to 24 months ; all received calcium ( 1500 mg/d diet and supplement ) and cholecalciferol ( 1,000 IU/d ) . MEASUREMENTS BMD of hip , lumbar spine , and mid-radius ; body composition ; sex hormones , calcium-regulating hormones ; bone turnover markers ; strength ; physical performance ; and safety parameters . RESULTS Ninety-nine men ( 75.6 % ) completed 12 months , and 62 ( 47.3 % ) completed end therapy ( mean 23 months ; range 16 - 24 months for 62 who completed therapy ) . Study adherence was 54 % , with 40 % of subjects maintaining 70 % or greater adherence . Testosterone and bioavailable testosterone levels at 12 months were 583 ng/dL and 157 ng/dL , respectively , in the treatment group . BMD on testosterone increased 1.4 % at the femoral neck and 3.2 % at the lumbar spine ( P=.005 ) and decreased 1.3 % at the mid-radius ( P lean mass and a decrease in fat mass in the testosterone group but no differences in strength or physical performance . There were no differences in safety parameters . CONCLUSION Older , frail men receiving testosterone replacement increased testosterone levels and had favorable changes in body composition , modest changes in axial BMD , and no substantial changes in physical function",
"OBJECTIVE To investigate the effects of oral testosterone undecanoate ( TU ) on symptoms associated with late-onset hypogonadism ( LOH ) . Design Multicenter , r and omized , double-blind , placebo-controlled . METHODS The study was performed in 14 study centers in seven European countries . Men > or = 50 years ( n=322 ) with symptoms of hypogonadism and testosterone deficiency ( calculated free testosterone and treated for 12 months with placebo or oral TU 80 , 160 or 240 mg/day . Primary outcome was the total score on the Aging Males ' Symptoms ( AMS ) rating scale after six months of treatment . RESULTS Treatment of mild-to-moderate LOH symptoms in subjects with borderline hypogonadism with oral TU result ed in an improved total AMS score at month 6 , but differences between groups were not statistically significant . There was greater improvement in subjects when compared with subjects > or = 60 years ( P=0.001 ) , but baseline testosterone level had no influence on treatment response . The AMS sexual symptoms domain improved with oral TU 160 mg/day at months 6 ( P=0.008 ) and 12 ( P=0.012 ) compared with placebo , but not with 80 and 240 mg/day . Treatment was well-tolerated and there were no between-group differences in adverse events or drop-out rates . CONCLUSIONS In one of the largest placebo-controlled studies of testosterone therapy in LOH , oral TU did not improve total AMS score in subjects with mild-to-moderate symptoms compared with placebo , except the sexual symptom sub-domain where a modest improvement was reported with oral TU 160 mg/day",
"BACKGROUND Erectile dysfunction and low testosterone levels frequently occur together . OBJECTIVE To determine whether addition of testosterone to sildenafil therapy improves erectile response in men with erectile dysfunction and low testosterone levels . DESIGN R and omized , double-blind , parallel , placebo-controlled trial . ( Clinical Trials.gov registration number : NCT00512707 ) SETTING Outpatient academic research center . PARTICIPANTS Men aged 40 to 70 years with scores of 25 or less for the erectile function domain ( EFD ) of the International Index of Erectile Function , total testosterone levels less than 11.45 nmol/L ( free testosterone levels less than 173.35 pmol/L ( INTERVENTION Sildenafil dose was optimized , and 140 participants were then r and omly assigned to 14 weeks of daily transdermal gel that contained 10-g testosterone for 70 participants and placebo for the remaining 70 participants . All participants were included in the primary analysis , although 10 in the testosterone group and 12 in the placebo group did not complete the study . RESULTS At baseline , the 2 groups had similar EFD scores . Administration of sildenafil alone was associated with a substantial increase in EFD score ( mean , 7.7 [ 95 % CI , 6.5 to 8.8 ] ) , but change in EFD score after r and omization did not differ between the groups ( difference , 2.2 [ CI , -0.8 to 5.1 ] ; P = 0.150 ) . The findings were similar for other domains of sexual function in younger men , more obese men , and men with lower baseline testosterone levels or an inadequate response to sildenafil alone . Frequency of adverse events was similar for testosterone and placebo groups . LIMITATION Whether testosterone could improve erectile function without sildenafil was not studied . CONCLUSION Sildenafil plus testosterone was not superior to sildenafil plus placebo in improving erectile function in men with erectile dysfunction and low testosterone levels . PRIMARY FUNDING SOURCE National Institute of Child Health and Human Development"
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Background Physical activity ( PA ) is a component of cardiac rehabilitation ( CR ) . However , life-long engagement in PA is required to maintain benefits gained . Wearable PA monitoring devices ( WPAM ) are thought to increase PA . There appear to be no review s which investigate the effect of WPAM in cardiac population s. We firstly aim ed to systematic ally review r and omised controlled trials within the cardiac population that investigated the effect WPAM had through the maintenance phase of CR . We specifically examined the effect on cardiorespiratory fitness ( CRF ) , amount and intensity of daily PA , and sedentary time . Secondly , we aim ed to collate outcome measures reported , reasons for drop out , adverse events , and psychological impact from utilising a WPAM . Methods A systematic search ( up to January 2019 ) of relevant data bases was completed , followed by a narrative synthesis , meta- analysis and qualitative analysis . Results Nine studies involving 1,352 participants were included . CRF was improved to a greater extent in participants using WPAM with exercise prescription or advice compared with controls ( MD 1.65 mL/kg/min;95 % confidence interval [ CI ; 0.64–2.66 ] ; p = 0.001 ; I2 = 0 % ) . There was no significant between group difference in six-minute walk test distance . In 70 % of studies , step count was greater in participants using a WPAM with exercise prescription or advice , however the overall effect was not significant ( SMD 0.45;95 % [ CI ; − 0.17 - 1.07 ] p = 0.15 ; I2 = 81 % ) . A sensitivity analysis result ed in significantly greater step counts in participants using a WPAM with exercise prescription or advice and reduced the heterogeneity from 81 to 0 % ( SMD 0.78;95 % [ CI;0.54–1.02 ] ; p significantly increased time spent in moderate and moderate-vigorous intensity PA . No difference between groups was found for sedentary time . Three of six studies reported improved psychological benefits .No cardiac adverse events related to physical activity were reported and 62 % of non-cardiac adverse events were primarily musculoskeletal injuries . Reasons for dropping out included medical conditions , lack of motivation , loss of interest , and technical difficulties . Conclusions Our meta- analysis showed WPAM with exercise prescription or advice are superior to no device in improving CRF in the maintenance phase of CR and no cardiac adverse events were reported with WPAM use . Our qualitative analysis showed evidence in favour of WPAM with exercise prescription or advice for both CRF and step count . WPAM with exercise prescription or advice did not change sedentary time . Psychological health and exercise intensity may potentially be enhanced by WPAM with exercise prescription or advice , however further research would strengthen this conclusion .Trial registration PROSPERO Registration Number : CRD42019106591
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"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",
"Objective A recent meta- analysis surmised pedometers were a useful panacea to independently reduce sedentary time ( ST ) . To further test and exp and on this deduction , we analyzed the ability of a consumer-wearable activity tracker to reduce ST and prolonged sedentary bouts ( PSB ) . We originally conducted a 12-month r and omized control trial where 800 employees from 13 organizations were assigned to control , activity tracker , or one of two activity tracker plus incentive groups design ed to increase step count . The primary outcome was accelerometer measured moderate-to-vigorous physical activity . Results We conducted a secondary analysis on accelerometer measured daily ST and PSB bouts . A general linear mixed model was used to examine changes in ST and prolonged sedentary bouts , followed by between-group pairwise comparisons . Regression analyses were conducted to examine the association of changes in step counts with ST and PSB . The changes in ST and PSB were not statistically significant and not different between the groups ( P Increases in step counts were concomitantly associated with decreases in ST and PSB , regardless of intervention ( P consumer-wearable activity trackers as a means to reduce sedentary behavior . Trial registration NCT01855776 Registered : August 8 ,",
"BACKGROUND Despite the increasing popularity of activity trackers , little evidence exists that they can improve health outcomes . We aim ed to investigate whether use of activity trackers , alone or in combination with cash incentives or charitable donations , lead to increases in physical activity and improvements in health outcomes . METHODS In this r and omised controlled trial , employees from 13 organisations in Singapore were r and omly assigned ( 1:1:1:1 ) with a computer generated assignment schedule to control ( no tracker or incentives ) , Fitbit Zip activity tracker , tracker plus charity incentives , or tracker plus cash incentives . Participants had to be English speaking , full-time employees , aged 21 - 65 years , able to walk at least ten steps continuously , and non-pregnant . Incentives were tied to weekly steps , and the primary outcome , moderate-to-vigorous physical activity ( MVPA ) bout min per week , was measured via a sealed accelerometer and assessed on an intention-to-treat basis at 6 months ( end of intervention ) and 12 months ( after a 6 month post-intervention follow-up period ) . Other outcome measures included steps , participants meeting 70 000 steps per week target , and health-related outcomes including weight , blood pressure , and quality -of-life measures . This trial is registered at Clinical Trials.gov , number NCT01855776 . FINDINGS Between June 13 , 2013 , and Aug 15 , 2014 , 800 participants were recruited and r and omly assigned to the control ( n=201 ) , Fitbit ( n=203 ) , charity ( n=199 ) , and cash ( n=197 ) groups . At 6 months , compared with control , the cash group logged an additional 29 MVPA bout min per week ( 95 % CI 10 - 47 ; p=0·0024 ) and the charity group an additional 21 MVPA bout min per week ( 2 - 39 ; p=0·0310 ) ; the difference between Fitbit only and control was not significant ( 16 MVPA bout min per week [ -2 to 35 ; p=0·0854 ] ) . Increases in MVPA bout min per week in the cash and charity groups were not significantly greater than that of the Fitbit group . At 12 months , the Fitbit group logged an additional 37 MVPA bout min per week ( 19 - 56 ; p=0·0001 ) and the charity group an additional 32 MVPA bout min per week ( 12 - 51 ; p=0·0013 ) compared with control ; the difference between cash and control was not significant ( 15 MVPA bout min per week [ -5 to 34 ; p=0·1363 ] ) . A decrease in physical activity of -23 MVPA bout min per week ( 95 % CI -42 to -4 ; p=0·0184 ) was seen when comparing the cash group with the Fitbit group . There were no improvements in any health outcomes ( weight , blood pressure , etc ) at either assessment . INTERPRETATION The cash incentive was most effective at increasing MVPA bout min per week at 6 months , but this effect was not sustained 6 months after the incentives were discontinued . At 12 months , the activity tracker with or without charity incentives were effective at stemming the reduction in MVPA bout min per week seen in the control group , but we identified no evidence of improvements in health outcomes , either with or without incentives , calling into question the value of these devices for health promotion . Although other incentive strategies might generate greater increases in step activity and improvements in health outcomes , incentives would probably need to be in place long term to avoid any potential decrease in physical activity result ing from discontinuation . FUNDING Ministry of Health , Singapore",
"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 Although many wearable devices for monitoring and tracking physical activity are available to consumers , relatively few research studies have been conducted to determine their efficacy in promoting health . Methods In this article , data on the use of consumer wearable devices in promoting healthy behaviors are summarized based upon bibliographic search es in PubMed and Psychology and Behavioral Sciences Collection with relevant search terms through September 2016 . Results A total of 274 articles were identified in the bibliographic search es . By screening abstract s or full-text articles , six pre/post test trials and seven r and omized controlled trials were identified . In initial trials , consumer wearable devices have been shown to increase physical activity and help users lose weight . However , the number of studies completed to date is small and limited by small sample sizes , short study duration s , and uncertain generalizability of the findings . Conclusions Future studies should utilize r and omized controlled trial research design s , larger sample sizes , and longer study periods to better establish the efficacy of wearable devices in promoting physical activity . Additional research is needed to determine the feasibility and effectiveness of wearable devices in promoting physical activity and weight loss in community setting s including communities affected by health disparities . Studies focusing on children and adolescents are also needed",
"QUESTIONS Does the PEDro scale measure only one construct ie , the method ological quality of clinical trials ? What is the hierarchy of items of the PEDro scale from least to most adhered to ? Is there any effect of year of publication of trials on item adherence ? Are PEDro scale ordinal scores equivalent to interval data ? DESIGN Rasch analysis of two independent sample s of 100 clinical trials from the PEDro data base scored using the PEDro scale . RESULTS Both sample s of PEDro data showed fit to the Rasch model with no item misfit . The PEDro scale item hierarchy was the same in both sample s , ranging from the most adhered to item r and om allocation , to the least adhered to item therapist blinding . There was no differential item functioning by year of publication . Original PEDro ordinal scores were highly correlated with transformed PEDro interval scores ( r = 0.99 ) . CONCLUSION The PEDro scale is a valid measure of the method ological quality of clinical trials . It is valid to sum PEDro scale item scores to obtain a total score that can be treated as interval level measurement and subjected to parametric statistical analysis",
"Background Given the global prevalence of insufficient physical activity ( PA ) , effective interventions that attenuate age-related decline in PA levels are needed . Mobile phone interventions that positively affect health ( mHealth ) show promise ; however , their impact on PA levels and fitness in young people is unclear and little is known about what makes a good mHealth app . Objective The aim was to determine the effects of two commercially available smartphone apps ( Zombies , Run and Get Running ) on cardiorespiratory fitness and PA levels in insufficiently active healthy young people . A second aim was to identify the features of the app design that may contribute to improved fitness and PA levels . Methods Apps for IMproving FITness ( AIM FIT ) was a 3-arm , parallel , r and omized controlled trial conducted in Auckl and , New Zeal and . Participants were recruited through advertisements in electronic mailing lists , local newspapers , flyers posted in community locations , and presentations at schools . Eligible young people aged 14 - 17 years were allocated at r and om to 1 of 3 conditions : ( 1 ) use of an immersive app ( Zombies , Run ) , ( 2 ) use of a nonimmersive app ( Get Running ) , or ( 3 ) usual behavior ( control ) . Both smartphone apps consisted of a fully automated 8-week training program design ed to improve fitness and ability to run 5 km ; however , the immersive app featured a game-themed design and narrative . Intention-to-treat analysis was performed using data collected face-to-face at baseline and 8 weeks , and all regression models were adjusted for baseline outcome value and gender . The primary outcome was cardiorespiratory fitness , objective ly assessed as time to complete the 1-mile run/walk test at 8 weeks . Secondary outcomes were PA levels ( accelerometry and self-reported ) , enjoyment , psychological need satisfaction , self-efficacy , and acceptability and usability of the apps . Results A total of 51 participants were r and omized to the immersive app intervention ( n=17 ) , nonimmersive app intervention ( n=16 ) , or the control group ( n=18 ) . The mean age of participants was 15.7 ( SD 1.2 ) years ; participants were mostly NZ Europeans ( 61 % , 31/51 ) and 57 % ( 29/51 ) were female . Overall retention rate was 96 % ( 49/51 ) . There was no significant intervention effect on the primary outcome using either of the apps . Compared to the control , time to complete the fitness test was –28.4 seconds shorter ( 95 % CI –66.5 to 9.82 , P=.20 ) for the immersive app group and –24.7 seconds ( 95 % CI –63.5 to 14.2 , P=.32 ) for the nonimmersive app group . No significant intervention effects were found for secondary outcomes . Conclusions Although apps have the ability to increase reach at a low cost , our pragmatic approach using readily available commercial apps as a st and -alone instrument did not have a significant effect on fitness . However , interest in future use of PA apps is promising and highlights a potentially important role of these tools in a multifaceted approach to increase fitness , promote PA , and consequently reduce the adverse health outcomes associated with insufficient activity . Trial Registration Australian New Zeal and Clinical Trials Registry : ACTRN12613001030763 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?ACTRN=12613001030763 ( Archived by WebCite at http://www.webcitation.org/6aasfJVTJ )",
"BACKGROUND Patients who have completed Phase II cardiac rehabilitation have low rates of maintenance of exercise after program completion , despite the importance of sustaining regular exercise to prevent future cardiac events . PURPOSE The efficacy of a home-based intervention to support exercise maintenance among patients who had completed Phase II cardiac rehabilitation versus contact control was evaluated . DESIGN An RCT was used to evaluate the intervention . Data were collected in 2005 - 2010 and analyzed in 2010 . SETTING / PARTICIPANTS One hundred thirty patients ( mean age=63.6 years [ SD=9.7 ] , 20.8 % female ) were r and omized to exercise counseling ( Maintenance Counseling group , n=64 ) or contact control ( Contact Control group , n=66 ) . INTERVENTION Maintenance Counseling group participants received a 6-month program of exercise counseling ( based on the transtheoretical model and social cognitive theory ) delivered via telephone , as well as print material s and feedback reports . MAIN OUTCOME MEASURES Assessment s of physical activity ( 7-Day Physical Activity Recall ) , motivational readiness for exercise , lipids , and physical functioning were conducted at baseline , 6 months , and 12 months . Objective accelerometer data were collected at the same time points . Fitness was assessed via maximal exercise stress tests at baseline and 6 months . RESULTS The Maintenance Counseling group reported significantly higher exercise participation than the Contact Control group at 12 months ( difference of 80 minutes , 95 % CI=22 , 137 ) . Group differences in exercise at 6 months were nonsignificant . The intervention significantly increased the probability of participants ' exercising at or above physical activity guidelines and attenuated regression in motivational readiness versus the Contact Control Group at 6 and 12 months . Self-reported physical functioning was significantly higher in the Maintenance Counseling group at 12 months . No group differences were seen in fitness at 6 months or lipid measures at 6 and 12 months . CONCLUSIONS A telephone-based intervention can help maintain exercise , prevent regression in motivational readiness for exercise , and improve physical functioning in this patient population",
"Background : Site‐based cardiac rehabilitation ( CR ) provides supervised exercise , education and motivation for patients . Graduates of CR have improved exercise tolerance . However , when participation in CR ceases , adherence to regular physical activity often declines , consequently leading to worsening risk factors and clinical events . Therefore , the purpose of this pilot study was to evaluate if a mHealth program could sustain the fitness and physical activity levels gained during CR . Methods and Results : A 12‐week mHealth program was implemented using physical activity trackers and health coaching . Twenty‐five patients were r and omized into mHealth or usual care after completing CR . The combination of a 4.7 ± 13.8 % increase in the mHealth and a 8.5 ± 11.5 % decrease in the usual care group result ed in a difference between groups ( P ≤ .05 ) for absolute peak VO2 . Usual care decreased the amount of moderate‐low physical activity minutes per week ( 117 ± 78 vs 50 ± 53 ; P .05 ) as well as moderate‐high ( 111 ± 87 vs 65 ± 64 ; P ( 138 ± 113 vs 159 ± 156 ; NS ) . The divergent changes between mHealth and usual care in moderate‐high physical activity minutes/week result ed in a difference between groups ( 21 ± 103 vs – 46 ± 36 ; P mHealth program of physical activity trackers and health coaching following CR graduation can sustain the gains in peak VO2 and physical activity achieved by site‐based CR",
"Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists",
"Objective To compare the long-term effectiveness of hospital versus telephone-monitored home-based exercise training during cardiac rehabilitation ( CR ) on exercise capacity and habitual physical activity . Design Six-year follow-up of patients who participated in a r and omised controlled trial of hospital versus monitored home-based exercise training during CR after coronary artery bypass graft surgery . Setting Outpatient CR centre in Central -South Ontario , Canada . Participants 196 Patients who participated in the original r and omised controlled trial and who attended an evaluation 1 year after CR . Interventions 6 months of home or hospital-based exercise training during CR . Main outcome measures Peak oxygen uptake ( peak Vo2 ) , Physical Activity Scale in the Elderly ( PASE ) to assess habitual activity , semi-structured interviews to assess vital status , demographic and descriptive information . Results Of the 196 eligible patients , 144 ( 75.5 % ; 74 Hospital , 70 Home ) were available for participation . Patients were predominantly male ( n=120 ; 83.3 % ) aged 70±9.5 years . Clinical and sociodemographic outcomes were similar in both groups . While exercise performance declined over time , there were significant between-group differences in peak Vo2 ( 1506±418 ml/min vs 1393±341 ml/min ; p=0.017 ) and PASE scores ( 166.7±90.2 vs 139.7±66.5 ; p=0.001 ) at 6-year follow-up in favour of the home group . Conclusions Home and hospital-based exercise training maintained exercise capacity above pre-CR levels 6 years after CR . Exercise training initiated in the home environment in low-risk patients undergoing coronary artery bypass graft surgery conferred greater long-term benefit on Vo2 and persistent physical activity compared with traditional hospital-based CR ",
"BACKGROUND Physical activity contributes to improve health and quality of life . However , the prevalence of sedentary lifestyle is elevated after an acute coronary syndrome . METHODS A r and omized controlled trial was performed to evaluate the impact of a pedometer-based program associated with a socio-cognitive intervention on physical activity behaviour , cardiovascular risk factors , and quality of life during the year after an acute coronary syndrome event . During hospitalization , we r and omized 32 patients to an experimental group and 33 patients to a usual care group . The experimental intervention included 6 consultations with a clinical nurse specialist during 12 months . RESULTS Groups characteristics were comparable . At baseline , the percentage of participants considered in the active range category was similar between groups ( 31 % vs 41 % ; P = 0.915 ) . However , the proportion of participants who were still active was greater in the experimental group than in the usual care group at 6 , 9 , and 12 months follow-up ( 75 % vs 41 % ; 68 % vs 36 % , and 83 % vs 55 % , respectively ; P overall quality of life and in health and the functioning scores were different between groups ( interaction effects [ groups by time ] P = 0.048 and P = 0.036 , respectively ) . CONCLUSIONS The use of a pedometer concomitantly with a socio-cognitive intervention improves adherence to physical activity and quality of life during the year after an acute coronary syndrome event . This finding is relevant because physical activity and quality of life are a great concern in preventive cardiology . These results support applying this innovative approach in cardiac rehabilitation programs",
"INTRODUCTION Direct-to-consumer mHealth devices are a potential asset to behavioral research but rarely tested as intervention tools . This trial examined the accelerometer-based Fitbit tracker and website as a low-touch physical activity intervention . The purpose of this study is to evaluate , within an RCT , the feasibility and preliminary efficacy of integrating the Fitbit tracker and website into a physical activity intervention for postmenopausal women . METHODS Fifty-one inactive , postmenopausal women with BMI ≥25.0 were r and omized to a 16-week web-based self-monitoring intervention ( n=25 ) or comparison group ( n=26 ) . The Web-Based Tracking Group received a Fitbit , instructional session , and follow-up call at 4 weeks . The comparison group received a st and ard pedometer . All were asked to perform 150 minutes/week of moderate to vigorous physical activity ( MVPA ) . Physical activity outcomes were measured by the ActiGraph GT3X+ accelerometer . RESULTS Data were collected and analyzed in 2013 - 2014 . Participants were aged 60 ( SD=7 ) years with BMI of 29.2 ( 3.5 ) kg/m(2 ) . Relative to baseline , the Web-Based Tracking Group increased MVPA by 62 ( 108 ) minutes/week ( p ) ; 10-minute MVPA bouts by 38 ( 83 ) minutes/week ( p=0.008 ) ; and steps by 789 ( 1,979 ) ( p=0.01 ) , compared to non-significant increases in the Pedometer Group ( between-group p=0.11 , 0.28 , and 0.30 , respectively ) . The Web-Based Tracking Group wore the tracker on 95 % of intervention days ; 96 % reported liking the website and 100 % liked the tracker . CONCLUSIONS The Fitbit was well accepted in this sample of women and associated with increased physical activity at 16 weeks . Leveraging direct-to-consumer mHealth technologies aligned with behavior change theories can strengthen physical activity interventions",
"Background Little is known about physical activity levels in patients with coronary artery disease ( CAD ) who are not engaged in cardiac rehabilitation . We explored the trajectory of physical activity after hospitalization for CAD , and examined the effects of demographic , medical , and activity-related factors on the trajectory . Design A prospect i ve cohort study . Methods A total of 782 patients were recruited during CAD-related hospitalization . Leisure-time activity energy expenditure ( AEE ) was measured 2 , 6 and 12 months later . Sex , age , education , reason for hospitalization , congestive heart failure ( CHF ) , diabetes , and physical activity before hospitalization were assessed at recruitment . Participation in cardiac rehabilitation was measured at follow-up . Results AEE was 1948 ± 1450 , 1676 ± 1290 , and 1637 ± 1486 kcal/week at 2 , 6 and 12 months , respectively . There was a negative effect of time from 2 months post-hospitalization on physical activity ( P previous level of physical activity ( those active before hospitalization more active after ; P Coronary artery bypass graft patients were more active than percutaneous coronary intervention ( PCI ) patients ( P = 0.033 ) . Conclusions Physical activity levels declined from 2 months after hospitalization . Specific subgroups ( e.g. less educated , younger ) were at greater risk of decline and other subgroups ( e.g. women , and PCI , CHF , and diabetic patients ) demonstrated lower physical activity . These groups need tailored interventions",
"Low adherence to cardiac rehabilitation ( CR ) might be improved by remote monitoring systems that can be used to motivate and supervise patients and tailor CR safely and effectively to their needs . The main objective of this study was to evaluate the feasibility of a smartphone-guided training system ( GEX ) and whether it could improve exercise capacity compared to CR delivered by conventional methods for patients with coronary artery disease ( CAD ) . A prospect i ve , r and omized , international , multi-center study comparing CR delivered by conventional means ( CG ) or by remote monitoring ( IG ) using a new training steering/feedback tool ( GEx System ) . This consisted of a sensor monitoring breathing rate and the electrocardiogram that transmitted information on training intensity , arrhythmias and adherence to training prescriptions , wirelessly via the internet , to a medical team that provided feedback and adjusted training prescriptions . Exercise capacity was evaluated prior to and 6 months after intervention . 118 patients ( 58 ± 10 years , 105 men ) with CAD referred for CR were r and omized ( IG : n = 55 , CG : n = 63 ) . However , 15 patients ( 27 % ) in the IG and 18 ( 29 % ) in the CG withdrew participation and technical problems prevented a further 21 patients ( 38 % ) in the IG from participating . No training-related complications occurred . For those who completed the study , peak VO2 improved more ( p = 0.005 ) in the IG ( 1.76 ± 4.1 ml/min/kg ) compared to CG ( −0.4 ± 2.7 ml/min/kg ) . A newly design ed system for home-based CR appears feasible , safe and improves exercise capacity compared to national CR . Technical problems reflected the complexity of applying remote monitoring solutions at an international level",
"OBJECTIVE To assess the efficacy of a strategy , based on telephone support oriented by accelerometer measurements , on the adherence to physical activity ( PA ) recommendations in cardiac patients not achieving PA recommendations . DESIGN Prospect i ve and r and omized study . SETTING A cardiac rehabilitation program ( CRP ) at a clinic . PARTICIPANTS Stable , noncompliant cardiac ( coronary artery disease , heart failure , post-cardiovascular surgery ) patients ( weekly moderate-intensity PA control group ( n=10 ) . INTERVENTIONS The intervention group wore an accelerometer for 8 weeks . Every 15 days , feedback and support were provided by telephone . The control group wore the accelerometer during the 8th week of the intervention only . MAIN OUTCOME MEASURES Active energy expenditure ( EE ) ( in kilocalories ) and the time spent doing light , moderate , or intense PA ( minutes per week ) . RESULTS In the intervention group , the time spent at moderate-intensity PA increased from 95.6±80.7 to 137.2±87.5 min/wk between the 1st and 8th week ( P=.002 ) , with 36.8 % of the sample achieving the target amount of moderate-intensity PA . During the 8th week , the EE averaged 543.7±144.1 kcal and 266.7±107.4 kcal in the intervention group and control group , respectively ( P=.004 ) . CONCLUSIONS Telephone support based on accelerometer recordings appeared to be an effective strategy to improve adherence to PA in noncompliant patients . This intervention could be implemented after a CRP as an inexpensive , modern , and easy-to-use strategy",
"Background Following publication of the PRISMA statement , the UK Centre for Review s and Dissemination ( CRD ) at the University of York in Engl and began to develop an international prospect i ve register of systematic review s with health-related outcomes . The objectives were to reduce unplanned duplication of review s and provide transparency in the review process , with the aim of minimizing reporting bias . Methods An international advisory group was formed and a consultation undertaken to establish the key items necessary for inclusion in the register and to gather views on various aspects of functionality . This article describes the development of the register , now called PROSPERO , and the process of registration . Results PROSPERO offers free registration and free public access to a unique prospect i ve register of systematic review s across all areas of health from all around the world . The dedicated web-based interface is electronically search able and available to all prospect i ve registrants . At the moment , inclusion in PROSPERO is restricted to systematic review s of the effects of interventions and strategies to prevent , diagnose , treat , and monitor health conditions , for which there is a health-related outcome .Ideally , registration should take place before the research ers have started formal screening against inclusion criteria but review s are eligible as long as they have not progressed beyond the point of completing data extraction .The required data set captures the key attributes of review design as well as the administrative details necessary for registration .Su bmi tted registration forms are checked against the scope for inclusion in PROSPERO and for clarity of content before being made publicly available on the register , rejected , or returned to the applicant for clarification . The public records include an audit trail of major changes to planned methods , details of when the review has been completed , and links to result ing publications when provided by the authors . Conclusions There has been international support and an enthusiastic response to the principle of prospect i ve registration of protocol s for systematic review s and to the development of PROSPERO .In October 2011 , PROSPERO contained 200 records of systematic review s being undertaken in 26 countries around the world on a diverse range of interventions",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"OBJECTIVE To determine the effectiveness of a pedometer-based telephone intervention on the physical activity levels of cardiac patients who did not attend a CRP . METHODS A r and omised controlled trial was conducted with 215 patients referred to a CRP but who could not or chose not to attend . The 6-week intervention included self-monitoring of physical activity using a pedometer and step calendar ; and behavioural counselling and goal setting sessions . Data were collected at baseline , 6 weeks and 6 months . RESULTS Study groups did not differ significantly at baseline . After 6 weeks , improvements in total physical activity time ( p=0.027 ) , total physical activity sessions ( p=0.003 ) , walking time ( p=0.013 ) and walking sessions ( p=0.002 ) in the intervention group were significantly greater than the control group after adjusting for baseline differences , and remained significant at 6 months . CONCLUSION The findings that the pedometer-based telephone intervention was successful in increasing physical activity levels in cardiac patients who did not attend a CRP could result in major health benefits for this group of people . PRACTICAL IMPLICATION S The pedometer-based telephone intervention could be offered as an effective and accessible option for patients not attending a CRP to increase and maintain their physical activity levels after hospitalisation",
"Background Exercise rehabilitation after cardiac surgery has beneficial effects , especially on a long-term basis . Rehabilitative programs with telemedicine plus appropriate technology might satisfy the needs of performing rehabilitation at home . Objective The purpose of this study was to compare exercise capacity after home-based cardiac rehabilitation ( HBCR ) or in-hospital rehabilitation in patients at low to medium risk for early mortality ( EuroSCORE 0–5 ) following cardiac surgery . Design A quasi-experimental study was conducted . Methods At hospital discharge , patients were given the option to decide whether to enroll in the HBCR program . Clinical examinations ( electrocardiography , cardiac echo color Doppler , chest radiography , blood sample s ) of patients in the HBCR group were collected during 4 weeks of rehabilitation , and exercise capacity ( assessed using the Six-Minute Walk Test [ 6MWT ] ) was assessed before and after rehabilitation . A group of patients admitted to the in-hospital rehabilitation program was used as a comparison group . Patients in the HBCR group were supervised at home by a medical doctor and telemonitored daily by a nurse and physical therapist by video conference . Periodic home visits by health staff also were performed . Results One hundred patients were recruited into the HBCR group . An equal number of patients was selected for the comparison group . At the end of the 4-week study , the 2 groups showed improvement from their respective baseline values only in the 6MWT . No difference was found in time × group interaction . Limitations Because patients self-selected to enroll in the HBCR program and because they were enrolled from a single clinical center , the results of the study can not be generalized . Conclusions In patients who self-selected HBCR , the program was found to be effective and comparable to the st and ard in-hospital rehabilitative approach , indicating that rehabilitation following cardiac surgery can be implemented effectively at home when coadministered with an integrated telemedicine service",
"BACKGROUND Cardiac rehabilitation is widely recognized as a medical management procedure that reduces mortality , but the cardiovascular safety of exercise training has not been clearly established . Published data are retrospective or out date d , as patient management has substantially progressed in recent years . The aim of this prospect i ve registry was to determine the current complication rate during exercise performed in the course of cardiac rehabilitation . METHODS This study was conducted by the Functional Evaluation and Cardiac Rehabilitation Working Group of the French Society of Cardiology . During a 1-year period , 65 cardiac rehabilitation centers reported that serious events had occurred during or 1 hour after an exercise stress test or a training session . Severe cardiovascular events were vali date d by a scientific committee . RESULTS A total of 25,420 patients ( 78 % men ; mean age , 61.3 years ) were included in the study . Initial indications for cardiac rehabilitation were post-cardiac surgery ( coronary bypass , 34.3 % ; valvular surgery , 18.4 % ) ; recent percutaneous coronary intervention ( 21.6 % ) ; and other coronary ( 13.2 % ) and noncoronary ( 12.5 % ) conditions . The study population underwent 42,419 exercise stress tests and 743,471 patient-hours of exercise training . Twenty severe cardiac events were reported : 5 were related to exercise testing and 15 were related to exercise training . The event rate was 1 per 8484 exercise stress tests and 1 per 49,565 patient-hours of exercise training ; the cardiac arrest rate was 1.3 per million patient-hours of exercise . Neither fatal complications nor emergency defibrillations were reported . CONCLUSION The frequency of major cardiovascular complications during supervised exercise training in France is quite low",
"BACKGROUND Despite proven benefits of cardiac rehabilitation ( CR ) , adherence to CR remains suboptimal . This trial aim ed to assess the impact of the patient education ' Learning and Coping Strategies ' ( LC ) on patient adherence to an eight-week CR program . METHODS 825 patients with ischaemic heart disease or heart failure were open label r and omised to either the LC arm ( LC plus CR ) or the control arm ( CR alone ) across three hospital units in Denmark . Both arms received same amount of training and education hours . LC consisted of individual clarifying interviews , participation of experienced patients as co-educators , situational , reflective and inductive teaching . The control arm received structured deductive teaching . The primary outcomes were patient adherence to at least 75 % of the exercise training or education sessions . We tested for subgroup effects on the primary outcomes using interaction terms . The primary outcomes were compared across arms using logistic regression . RESULTS More patients in the LC arm adhered to at least 75 % of the exercise training sessions than control ( 80 % versus 73 % , adjusted odds ratio (OR):1.48 ; 95 % CI:1.07 to 2.05 , P=0.018 ) and 75 % of education sessions ( 79 % versus 70 % , adjusted OR:1.61 , 1.17 to 2.22 , P=0.003 ) . Some evidence of larger effects of LC on adherence was seen for patients with heart failure , low education and household income . CONCLUSIONS Addition of LC strategies improved adherence in rehabilitation both in terms of exercise training and education . Patients with heart failure , low levels of education and household income appear to benefit most from this adherence promoting intervention . TRIAL REGISTRATION www . clinical trials.gov identifier NCT01668394",
"PURPOSE In Australia , patient adherence to physical activity after a cardiac rehabilitation program ( CRP ) is poor . This study evaluated the efficacy of a pedometer-based intervention to increase physical activity after CRP . METHODS Patients ( n = 110 ) who had attended a CRP were r and omized into an intervention or a control group . The 6-week intervention included self-monitored physical activity using a pedometer and step calendar and 2 behavioral counseling and goal - setting sessions . Self-reported physical activity and psychosocial status were collected at baseline , 6 weeks , and 6 months . Participant exercise capacity was measured using a gas exchange analysis system . RESULTS Study groups were not significantly different at baseline , except for occupation . At 6 weeks and 6 months , improvements in total physical activity sessions ( P = .002 and P = .016 , respectively ) , walking minutes ( P = .013 , 6 weeks only ) , and walking sessions ( P total physical activity minutes in the intervention group also increased significantly more than those in the control group ( P = .044 ) . These self-reported behavioral changes were corroborated by improvements in cardiorespiratory fitness at 6 months in the intervention group ( P = .01 ) . There were also significant improvements in psychosocial health at 6 weeks and 6 months in the intervention group . CONCLUSION The pedometer-based intervention was successful in increasing physical activity in cardiac patients after a CRP . This intervention could be given to patients to promote adherence to physical activity guidelines after a CRP , particularly in centers where maintenance programs are not available",
"BACKGROUND Measuring adherence to exercise is important to clinicians and research ers because inadequate adherence can adversely affect the effectiveness of an exercise program and cloud the relationship between exercise and clinical outcomes . Hence , assessment strategies for adherence to exercise , as with assessment strategies for other outcomes , must have demonstrated validity if they are to be employed with confidence . We conducted this study to determine the validity of pedometers as a measure of exercise adherence to a home-based walking program in heart failure patients . METHODS AND RESULTS Exercise adherence was measured using pedometers in 38 patients ( 74 % men ) age 54.1 + /- 11.7 years who participated in a 12-month home-based walking program . A comparison of functional status as measured by the 6-minute walk distance and peak oxygen uptake ( VO2 max ) at 6 months into the exercise training program was made between 2 groups of participants who were thought to represent adherers and nonadherers : participants who demonstrated > or = 10 % change in pedometer scores ( n = 20 ) and those who showed no change in pedometer scores ( n = 18 ) from baseline to 6 months . Patients who showed improvements in their pedometer scores over 6 months had better functional status at 6 months ( 6-minute walk distance 1718 + /- 46 versus 1012 + /- 25 meters , F = 5.699 , P = .022 ; VO 2 max 17 + /- 0.7 versus 10 + /- 0.5 units , F = 7.162 , P = .011 ) when compared with patients whose pedometers reflected minimal change in distance walked ( ie , Pedometers are inexpensive and readily available to both clinicians and research ers . The results of this study suggest that they may be a valid indicator of exercise adherence in heart failure patients who participate in a home-based walking program",
"BACKGROUND To evaluate the long-term cost-effectiveness of two home-based cardiac rehabilitation ( CR ) interventions ( Healthy Weight ( HW ) and Physical Activity ( PA ) ) for patients with cardiovascular disease ( CVD ) , who had been referred to cardiac rehabilitation ( CR ) but had not attended . The interventions consisted of pedometer-based telephone coaching sessions on weight , nutrition and physical activity ( HW group ) or physical activity only ( PA group ) and were compared to a control group who received information brochures about physical activity . METHODS A cost-effectiveness analysis was conducted using data from two r and omised controlled trials . One trial compared HW to PA ( PANACHE study ) , and the second compared PA to usual care . A Markov model was developed which used one risk factor , body mass index ( BMI ) to determine the CVD risk level and mortality . Patient-level data from the trials were used to determine the transitions to CVD states and healthcare related costs . The model was run for separate cohorts of males and females . Univariate and probabilistic sensitivity analysis were conducted to test the robustness of the results . RESULTS Given a willingness-to-pay threshold of $ 50,000/QALY , in the long run , both the HW and PA interventions are cost-effective compared with usual care . While the HW intervention is more effective , it also costs more than both the PA intervention and the control group due to higher intervention costs . However , the HW intervention is still cost-effective relative to the PA intervention for both men and women . Sensitivity analysis suggests that the results are robust . CONCLUSION The results of this paper provide evidence of the long-term cost-effectiveness of home-based CR interventions for patients who are referred to CR but do not attend . Both the HW and PA interventions can be recommended as cost-effective home-based CR programs , especially for people lacking access to hospital services or who are unable to participate in traditional CR programs",
"BACKGROUND St and ard cardiac rehabilitation ( CR ) is insufficient to help patients achieve an active lifestyle . The effects of two advanced and extended behavioral CR interventions on physical activity ( PA ) and sedentary behavior ( SB ) were assessed . METHODS In total , 731 patients with ACS were r and omized to 1 ) 3months of st and ard CR ( CR-only ) ; 2 ) 3months of st and ard CR with three pedometer-based , face-to-face PA group counseling sessions followed by 9months of aftercare with three general lifestyle , face-to-face group counseling sessions ( CR+F ) ; or 3 ) 3months of st and ard CR , followed by 9months of aftercare with five to six general lifestyle , telephonic counseling sessions ( CR+T ) . An accelerometer recorded PA and SB at r and omization , 3months , 12months , and 18months . RESULTS The CR+F group did not improve their moderate-to-vigorous intensity PA ( MVPA ) or SB time compared to CR-only ( between-group difference=0.24 % MVPA , P=0.349 ; and 0.39 % SB , P=0.529 ) . However , step count ( between-group difference=513 steps/day , P=0.021 ) and time in prolonged MVPA ( OR=2.14 , P=0.054 ) improved at 3months as compared to CR-only . The improvement in prolonged MVPA was maintained at 18months ( OR=1.91 , P=0.033 ) . The CR+T group did not improve PA or SB compared to CR-only . CONCLUSIONS Adding three pedometer-based , face-to-face group PA counseling sessions to st and ard CR increased daily step count and time in prolonged MVPA . The latter persisted at 18months . A telephonic after-care program did not improve PA or SB . Although after-care should be optimized to improve long-term adherence , face-to-face group counseling with objective PA feedback should be added to st and ard CR",
"This study examined the use of activity trackers alone or combined with weekly communication through email to improve activity and body composition over one academic year in medical students . This r and omized clinical trial conducted at the New York Institute of Technology from July 7 , 2016 through June 4 , 2017 enrolled 120 medical students . The first group ( Fitbit-Plus ) wore activity trackers and received weekly emails offering fitness challenges and lifestyle modification challenges . The second group ( Fitbit-Only ) received only activity trackers and did not receive weekly emails . The third group ( Control ) was asked not to purchase an activity tracker of any kind throughout the study . All groups had a body composition analysis prior to the start of the academic year and at the end of the first academic year . Outcome measures included step count and body composition ( body fat percentage and lean body mass ) . The results showed the overall mean daily steps were greater in the Fitbit-Plus group than the Fitbit-Only group for the academic year ( 7429 ± 2833 vs. 6483 ± 2359 ) with only months April and May showing a significant difference between the groups ( p = 0.011 ; p = 0.044 ) . Body fat percentage decreased in the Fitbit-Plus overweight women ( 2.1 ± 1.6 % ) lean body mass increased in the Fitbit-Plus group in overweight men ( 2.4 ± 4.6 lbs . ) . A subsequent finding of this study showed improved body composition in a small sub-group of over-weight students . Weekly behavioral challenges combined with an activity tracker increased step count in medical students compared to an activity tracker alone . Clinical trials.gov Identifier : NCT02778009",
"Background Community-dwelling older adults living in rural areas are in a less favorable environment for health care compared with urban older adults . We believe that intermittent coaching through wearable devices can help optimize health care for older adults in medically limited environments . Objective We aim ed to evaluate whether a wearable device and mobile-based intermittent coaching or self-management could increase physical activity and health outcomes of small groups of older adults in rural areas . Methods To address the above evaluation goal , we carried out the “ Smart Walk ” program , a health care model wherein a wearable device is used to promote self-exercise particularly among community-dwelling older adults managed by a community health center . We r and omly selected older adults who had enrolled in a population -based , prospect i ve cohort study of aging , the Aging Study of Pyeongchang Rural Area . The “ Smart Walk ” program was a 13-month program conducted from March 2017 to March 2018 and included 6 months of coaching , 1 month of rest , and 6 months of self-management . We evaluated differences in physical activity and health outcomes according to frailty status and conducted pre- and postanalyses of the Smart Walk program . We also performed intergroup analysis according to adherence of wearable devices . Results We recruited 22 participants ( 11 robust and 11 prefrail older adults ) . The two groups were similar in most of the variables , except for age , frailty index , and Short Physical Performance Battery score associated with frailty criteria . After a 6-month coaching program , the prefrail group showed significant improvement in usual gait speed ( mean 0.73 [ SD 0.11 ] vs mean 0.96 [ SD 0.27 ] , P=.02 ) , International Physical Activity Question naire scores in kcal ( mean 2790.36 [ SD 2224.62 ] vs mean 7589.72 [ SD 4452.52 ] , P=.01 ) , and European Quality of Life-5 Dimensions score ( mean 0.84 [ SD 0.07 ] vs mean 0.90 [ SD 0.07 ] , P=.02 ) , although no significant improvement was found in the robust group . The average total step count was significantly different and was approximately four times higher in the coaching period than in the self-management period ( 5,584,295.83 vs 1,289,084.66 , P increased body weight and body mass index by mean 0.65 ( SD 1.317 ) and mean 0.097 ( SD 0.513 ) , respectively , compared with the other groups . Conclusions Our “ Smart Walk ” program improved physical fitness , anthropometric measurements , and geriatric assessment categories in a small group of older adults in rural areas with limited re sources for monitoring . Further validation through various rural public health centers and in a large number of rural older adults is required"
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AIM The effects of nutrient-based treatments , including adjunctive vitamin or antioxidant supplementation , have been explored extensively in long-term schizophrenia . However , no systematic evaluation of trials in " first-episode psychosis " ( FEP ) has been conducted , despite the potential benefits of using these treatments during the early stages of illness . Therefore , we aim ed to review all studies examining efficacy , tolerability and the biological mechanisms of action , of nutrient supplementation in FEP . METHODS A systematic review of electronic data bases was conducted from inception to July 2017 . All information on feasibility , clinical outcomes and mechanistic findings from nutrient supplementation clinical trials was extracted and systematic ally synthesized . RESULTS Eleven studies with a total of 451 patients with FEP ( from 8 independent r and omized controlled trials ) were eligible for inclusion . Six studies examined omega-3 fatty acids , with inconsistent effects on psychiatric symptoms . However , mechanistic studies found significant improvements in hippocampal neuronal health and brain glutathione . Antioxidants " n-acetyl cysteine " ( n = 1 ) and vitamin C ( n = 2 ) also improved oxidative status in FEP , which was associated with reduced psychiatric symptoms . No benefits were found for vitamin E ( n = 1 ) . Finally , one study trialling the amino acid taurine , showed significant improvements in positive symptoms and psychosocial functioning . CONCLUSION There is preliminary evidence that taurine improves outcomes in FEP , whereas effects of omega-3 and antioxidant vitamins/amino-acids are inconsistent ; perhaps mainly benefitting patients with high levels of oxidative stress . Future studies should evaluate multifaceted dietary and supplementation interventions in FEP ; targeting-specific nutritional deficits and the range of aberrant biological processes implicated in the disorder
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"Abstract Haloperidol treatment has been shown to produce oxidative stress in patients with acute psychosis . Oxidative stress has also been implicated in the extrapyramidal symptoms ( EPS ) produced by haloperidol . Supporting the oxidative stress hypothesis , vitamin E ( antioxidant ) has demonstrated therapeutic efficacy in idiopathic parkinsonism . The prophylactic efficacy of vitamin E ( antioxidant ) on haloperidol-induced EPS was examined in a r and omized controlled trial . The sample consisted of 24 acute psychotic patients hospitalized for a 2-week trial . All patients received oral haloperidol 10 mg/day . The sample was equally r and omized to receive either haloperidol alone or haloperidol + vitamin E ( 3200 IU/day ) . EPS was rated at recruitment , both live and with video records , and on days 3 , 7 , 10 and 14 . Psychopathology was rated at recruitment and weekly thereafter . Vitamin E had no prophylactic effect on drug-induced EPS , though it did not interfere with the therapeutic efficacy of haloperidol",
"Abstract Biomarker-guided treatments are needed in psychiatry , and previous data suggest oxidative stress may be a target in schizophrenia . A previous add-on trial with the antioxidant N-acetylcysteine ( NAC ) led to negative symptom reductions in chronic patients . We aim to study NAC ’s impact on symptoms and neurocognition in early psychosis ( EP ) and to explore whether glutathione (GSH)/redox markers could represent valid biomarkers to guide treatment . In a double-blind , r and omized , placebo-controlled trial in 63 EP patients , we assessed the effect of NAC supplementation ( 2700 mg/day , 6 months ) on PANSS , neurocognition , and redox markers ( brain GSH [ GSHmPFC ] , blood cells GSH levels [ GSHBC ] , GSH peroxidase activity [ GPxBC ] ) . No changes in negative or positive symptoms or functional outcome were observed with NAC , but significant improvements were found in favor of NAC on neurocognition ( processing speed ) . NAC also led to increases of GSHmPFC by 23 % ( P = .005 ) and GSHBC by 19 % ( P = .05 ) . In patients with high-baseline GPxBC compared to low-baseline GPxBC , subgroup explorations revealed a link between changes of positive symptoms and changes of redox status with NAC . In conclusion , NAC supplementation in a limited sample of EP patients did not improve negative symptoms , which were at modest baseline levels . However , NAC led to some neurocognitive improvements and an increase in brain GSH levels , indicating good target engagement . Blood GPx activity , a redox peripheral index associated with brain GSH levels , could help identify a subgroup of patients who improve their positive symptoms with NAC . Thus , future trials with antioxidants in EP should consider biomarker-guided treatment",
"OBJECTIVE Taurine is an inhibitory neuromodulatory amino acid in the central nervous system that activates the GABA- and glycine-insensitive chloride channel and inhibits the N-methyl-D-aspartate receptor . It also functions as a neuroprotective agent and has a role in neural development and neurogenesis . The aim of this study was to determine the efficacy of adjunctive taurine in improving symptomatology and cognition among patients with a DSM-IV first-episode psychotic disorder . METHODS 121 patients with first-episode psychosis , aged 18 - 25 years , attending early intervention services consented to participate in this r and omized , double-blind , placebo-controlled trial conducted from January 2007 to May 2009 . Patients taking low-dose antipsychotic medication were r and omly assigned to receive once-daily taurine 4 g or placebo for 12 weeks . The co primary outcomes were change in symptomatology ( measured by the Brief Psychiatric Rating Scale [ BPRS ] total score ) and change in cognition ( measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia [ MATRICS ] Consensus Cognitive Battery composite score ) at 12 weeks . Secondary outcomes included tolerability and safety and additional clinical and functioning measures . RESULTS 86 participants ( n = 47 taurine ; n = 39 placebo ) were included in the final analysis . Taurine significantly improved symptomatology measured by the BPRS total score ( 95 % CI , 1.8 - 8.5 ; P = .004 ) and psychotic subscale ( 95 % CI , 0.1 - 1.5 ; P = .026 ) compared to placebo . Additionally , improvements were observed in the Calgary Depression Scale for Schizophrenia ( 95 % CI , 0.1 - 3.0 ; P = .047 ) and Global Assessment of Functioning ( 95 % CI , 0.3 - 8.8 ; P = .04 ) scores . There was no group difference in composite cognitive score ( 95 % CI , -1.7 to 1.0 ; P = .582 ) . A significant group difference was found on one safety and tolerability item ( psychic item 2 , asthenia/lassitude/increased fatigability ) of the Udvalg for Kliniske Undersogelser , with the taurine group showing a more favorable outcome ( P = .006 ) . CONCLUSIONS Adjunctive taurine did not improve cognition , but it appears to improve psychopathology in patients with first-episode psychosis . The use of taurine warrants further investigation in larger r and omized studies , particularly early in the course of psychosis . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00420823",
"BACKGROUND While antipsychotics are effective in the maintenance treatment of schizophrenia they have safety and tolerability risks . We investigated whether a combination of omega-3 polyunsaturated fatty acids ( ω-3 PUFAs ) and a metabolic antioxidant , alpha-lipoic acid ( α-LA ) , is effective in preventing relapse after antipsychotic discontinuation in subjects who were successfully treated for 2 - 3 years after a first-episode of schizophrenia , schizo-affective or schizophreniform disorder . METHODS In this r and omized , double-blind , placebo controlled study antipsychotic treatment was tapered and discontinued and participants received either ω-3 PUFAs ( eicosapentaenoic acid 2g/day and docosahexaenoic acid 1g/day)+α-LA 300 mg/day or placebo . Subjects were followed up for two years , or until relapse . RESULTS Recruitment was terminated prematurely due to the high relapse rates in both treatment groups as well as the severity of some of the relapse episodes . Of the 33 participants , 19/21(90 % ) r and omized to ω-3 PUFAs+α-LA relapsed and one ( 5 % ) completed two years without relapse ( p=0.6 ) ; and 9/12 ( 75 % ) r and omized to placebo relapsed and none completed two years without relapse . Mean times to relapse were 39.8 ± 25.4 and 38.3 ± 26.6 weeks for the ω-3 PUFAs+α-LA and placebo groups , respectively ( p=0.9 ) . There were no significant differences between the groups in relapse symptom severity . CONCLUSIONS We found no evidence that ω-3 PUFAs+α-LA could be a suitable alternative to maintenance antipsychotic treatment in relapse prevention , in this small study . Antipsychotic discontinuation after a single episode of schizophrenia carries a very high risk of relapse , and treatment guidelines endorsing this practice should be revised",
"After devastating flooding in southern Alberta in June 2013 , we attempted to replicate a New Zeal and r and omised trial that showed that micronutrient ( minerals , vitamins ) consumption after the earthquakes of 2010 - 11 result ed in improved mental health . Residents of southern Alberta were invited to participate in a study on the potential benefit of nutrient supplements following a natural disaster . Fifty-six adults aged 23 - 66 were r and omised to receive a single nutrient ( vitamin D , n=17 ) , a few-nutrients formula ( B-Complex , n=21 ) , or a broad-spectrum mineral/vitamin formula ( BSMV , n=18 ) . Self-reported changes in depression , anxiety and stress were monitored for six weeks . Although all groups showed substantial decreases on all measures , those consuming the B-Complex and the BSMV formulas showed significantly greater improvement in stress and anxiety compared with those consuming the single nutrient , with large effect sizes ( Cohen 's d range 0.76 - 1.08 ) . There were no group differences between those consuming the B-Complex and BSMV . The use of nutrient formulas with multiple minerals and /or vitamins to minimise stress associated with natural disasters is now supported by three studies . Further research should be carried out to evaluate the potential population benefit that might accrue if such formulas were distributed as a post-disaster public health measure",
"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",
"Long-chain omega-3 polyunsaturated fatty acids ( PUFAs ) are essential for neural development and function . As key components of brain tissue , omega-3 PUFAs play critical roles in brain development and function , and a lack of these fatty acids has been implicated in a number of mental health conditions over the lifespan , including schizophrenia . We have previously shown that a 12-week intervention with omega-3 PUFAs reduced the risk of progression to psychotic disorder in young people with subthreshold psychotic states for a 12-month period compared with placebo . We have now completed a longer-term follow-up of this r and omized , double-blind , placebo-controlled trial , at a median of 6.7 years . Here we show that brief intervention with omega-3 PUFAs reduced both the risk of progression to psychotic disorder and psychiatric morbidity in general in this study . The majority of the individuals from the omega-3 group did not show severe functional impairment and no longer experienced attenuated psychotic symptoms at follow-up",
"BACKGROUND Brain glutathione levels are decreased in schizophrenia , a disorder that often is chronic and refractory to treatment . N-acetyl cysteine ( NAC ) increases brain glutathione in rodents . This study was conducted to evaluate the safety and effectiveness of oral NAC ( 1 g orally twice daily [ b.i.d . ] ) as an add-on to maintenance medication for the treatment of chronic schizophrenia over a 24-week period . METHODS A r and omized , multicenter , double-blind , placebo-controlled study . The primary readout was change from baseline on the Positive and Negative Symptoms Scale ( PANSS ) and its components . Secondary readouts included the Clinical Global Impression ( CGI ) Severity and Improvement scales , as well as general functioning and extrapyramidal rating scales . Changes following a 4-week treatment discontinuation were evaluated . One hundred forty people with chronic schizophrenia on maintenance antipsychotic medication were r and omized ; 84 completed treatment . RESULTS Intent-to-treat analysis revealed that subjects treated with NAC improved more than placebo-treated subjects over the study period in PANSS total [ -5.97 ( -10.44 , -1.51 ) , p = .009 ] , PANSS negative [ mean difference -1.83 ( 95 % confidence interval : -3.33 , -.32 ) , p = .018 ] , and PANSS general [ -2.79 ( -5.38 , -.20 ) , p = .035 ] , CGI-Severity ( CGI-S ) [ -.26 ( -.44 , -.08 ) , p = .004 ] , and CGI-Improvement ( CGI-I ) [ -.22 ( -.41 , -.03 ) , p = .025 ] scores . No significant change on the PANSS positive subscale was seen . N-acetyl cysteine treatment also was associated with an improvement in akathisia ( p = .022 ) . Effect sizes at end point were consistent with moderate benefits . CONCLUSIONS These data suggest that adjunctive NAC has potential as a safe and moderately effective augmentation strategy for chronic schizophrenia",
"OBJECTIVE To investigate if ethyl-eicosapentaenoic acid ( E-EPA ) augmentation improves antipsychotic efficacy and tolerability in first-episode psychosis ( FEP ) . METHOD We performed a 12-week , r and omized , double-blind , placebo-controlled trial of 2-g E-EPA augmentation in 80 FEP patients . Sixty-nine patients were eligible for analysis ; a post hoc analysis was computed for a subgroup of nonaffective FEP patients ( N = 53 ) . The first participant was included in November 2000 and the last participant completed the trial in August 2003 . Primary outcome measures were symptom change scores and time to first response , while tolerability measures and cumulative antipsychotic dose were secondary outcome measures . RESULTS Analysis of covariance controlling for baseline symptoms found no significant mean difference between E-EPA and placebo at week 12 for symptom change scores . Cox regression analysis revealed a significant treatment by diagnosis interaction ( p = .024 ) for time to first response favoring E-EPA in nonaffective psychosis . Post hoc analysis for cumulative response rates further confirmed a higher response rate at week 6 ( 42.9 % [ 15/35 ] vs. 17.6 % [ 6/34 ] for all participants , p = .036 ; 54.2 % [ 13/24 ] vs. 17.2 % [ 5/29 ] for the nonaffective psychosis subset , p = .008 ) ; however , the difference at week 12 was no longer significant . Analysis of secondary outcome measures revealed that E-EPA-augmented participants needed 20 % less antipsychotic medication between weeks 4 through 6 ( p = .03 ) , had less extrapyramidal side effects in the initial 9 weeks ( p constipation ( p = .011 ) and fewer sexual side effects ( p = .016 ) than those treated with antipsychotic medication alone . CONCLUSION The findings suggest that E-EPA may accelerate treatment response and improve the tolerability of antipsychotic medications . However , it was not possible to demonstrate a sustained symptomatic benefit of E-EPA in early psychosis , possibly due to a ceiling effect , since a high proportion of first-episode patients already achieve symptomatic remission with antipsychotic medication alone . Further controlled trials in nonaffective early psychosis seem warranted . TRIAL REGISTRATION Australian Clinical Trials Registry identifier 12605000267651 ( http://actr.org.au )",
"Background The possible therapeutic impact of dietary changes on existing mental illness is largely unknown . Using a r and omised controlled trial design , we aim ed to investigate the efficacy of a dietary improvement program for the treatment of major depressive episodes . Methods ‘ SMILES ’ was a 12-week , parallel-group , single blind , r and omised controlled trial of an adjunctive dietary intervention in the treatment of moderate to severe depression . The intervention consisted of seven individual nutritional consulting sessions delivered by a clinical dietician . The control condition comprised a social support protocol to the same visit schedule and length . Depression symptomatology was the primary endpoint , assessed using the Montgomery – Åsberg Depression Rating Scale ( MADRS ) at 12 weeks . Secondary outcomes included remission and change of symptoms , mood and anxiety . Analyses utilised a likelihood-based mixed-effects model repeated measures ( MMRM ) approach . The robustness of estimates was investigated through sensitivity analyses . Results We assessed 166 individuals for eligibility , of whom 67 were enrolled ( diet intervention , n = 33 ; control , n = 34 ) . Of these , 55 were utilising some form of therapy : 21 were using psychotherapy and pharmacotherapy combined ; 9 were using exclusively psychotherapy ; and 25 were using only pharmacotherapy . There were 31 in the diet support group and 25 in the social support control group who had complete data at 12 weeks . The dietary support group demonstrated significantly greater improvement between baseline and 12 weeks on the MADRS than the social support control group , t(60.7 ) = 4.38 , p . Remission , defined as a MADRS score 10 , was achieved for 32.3 % ( n = 10 ) and 8.0 % ( n = 2 ) of the intervention and control groups , respectively ( χ2 ( 1 ) = 4.84 , p = 0.028 ) ; number needed to treat ( NNT ) based on remission scores was 4.1 ( 95 % CI of NNT 2.3–27.8 ) . A sensitivity analysis , testing departures from the missing at r and om ( MAR ) assumption for dropouts , indicated that the impact of the intervention was robust to violations of MAR assumptions . Conclusions These results indicate that dietary improvement may provide an efficacious and accessible treatment strategy for the management of this highly prevalent mental disorder , the benefits of which could extend to the management of common co-morbidities . Trial registration Australia and New Zeal and Clinical Trials Register ( ANZCTR ) : ACTRN12612000251820 . Registered on 29 February 2012",
"OBJECTIVE Based on clues from epidemiology and animal experiments , low vitamin D during early life has been proposed as a risk factor for schizophrenia . The aim of this study was to explore the association between the use of vitamin D supplements during the first year of life and risk of developing schizophrenia . METHOD Subjects were drawn from the Northern Finl and 1966 Birth Cohort ( n=9,114 ) . During the first year of life , data were collected about the frequency and dose of vitamin D supplementation . Our primary outcome measures were schizophrenia , psychotic disorders other than schizophrenia , and nonpsychotic disorders as diagnosed by age 31 years . Males and females were examined separately . RESULTS In males , the use of either irregular or regular vitamin D supplements was associated with a reduced risk of schizophrenia ( Risk ratio (RR)=0.08 , 95 % CI 0.01 - 0.95 ; RR=0.12 , 95 % CI 0.02 - 0.90 , respectively ) compared with no supplementation . In males , the use of at least 2000 IU of vitamin D was associated with a reduced risk of schizophrenia ( RR=0.23 , 95 % CI 0.06 - 0.95 ) compared to those on lower doses . There were no significant associations between either the frequency or dose of vitamin D supplements and ( a ) schizophrenia in females , nor with ( b ) nonpsychotic disorder or psychotic disorders other than schizophrenia in either males or females . CONCLUSION Vitamin D supplementation during the first year of life is associated with a reduced risk of schizophrenia in males . Preventing hypovitaminosis D during early life may reduce the incidence of schizophrenia",
"This study explores whether inflammatory biomarkers act as moderators of clinical response to omega-3 ( n-3 ) fatty acids in subjects with major depressive disorder ( MDD ) . One hundred fifty-five subjects with Diagnostic and Statistical Manual of Mental Disorders , 4th Edition ( DSM-IV ) MDD , a baseline 17-item Hamilton Depression Rating Scale ( HAM-D-17 ) score ⩾15 and baseline biomarker data ( interleukin (IL)-1ra , IL-6 , high-sensitivity C-reactive protein ( hs-CRP ) , leptin and adiponectin ) were r and omized between 18 May 2006 and 30 June 2011 to 8 weeks of double-blind treatment with eicosapentaenoic acid (EPA)-enriched n-3 1060 mg day−1 , docosahexaenoic acid (DHA)-enriched n-3 900 mg day−1 or placebo . Outcomes were determined using mixed model repeated measures analysis for ‘ high ’ and ‘ low ’ inflammation groups based on individual and combined biomarkers . Results are presented in terms of st and ardized treatment effect size ( ES ) for change in HAM-D-17 from baseline to treatment week 8 . Although overall treatment group differences were negligible ( ES=−0.13 to + 0.04 ) , subjects with any ‘ high ’ inflammation improved more on EPA than placebo ( ES=−0.39 ) or DHA ( ES=−0.60 ) and less on DHA than placebo ( ES=+0.21 ) ; furthermore , EPA-placebo separation increased with increasing numbers of markers of high inflammation . Subjects r and omized to EPA with ‘ high ’ IL-1ra or hs-CRP or low adiponectin ( ‘ high ’ inflammation ) had medium ES decreases in HAM-D-17 scores vs subjects ‘ low ’ on these biomarkers . Subjects with ‘ high ’ hs-CRP , IL-6 or leptin were less placebo-responsive than subjects with low levels of these biomarkers ( medium to large ES differences ) . Employing multiple markers of inflammation facilitated identification of a more homogeneous cohort of subjects with MDD responding to EPA vs placebo in our cohort . Studies are needed to replicate and extend this proof-of-concept work",
"The onset and early course of schizophrenia is associated with subtle loss of grey matter which may be responsible for the evolution and persistence of symptoms such as apathy , emotional blunting , and social withdrawal . Such ‘ negative ’ symptoms are unaffected by current antipsychotic therapies . There is evidence that the antibiotic minocycline has neuroprotective properties . We investigated whether the addition of minocycline to treatment as usual ( TAU ) for 1 year in early psychosis would reduce negative symptoms compared with placebo . In total , 144 participants within 5 years of first onset in Brazil and Pakistan were r and omised to receive TAU plus placebo or minocycline . The primary outcome measures were the negative and positive syndrome ratings using the Positive and Negative Syndrome Scale . Some 94 patients completed the trial . The mean improvement in negative symptoms for the minocycline group was 9.2 and in the placebo group 4.7 , an adjusted difference of 3.53 ( s.e . 1.01 ) 95 % CI : 1.55 , 5.51 ; p minocycline to TAU early in the course of schizophrenia predominantly improves negative symptoms . Whether this is mediated by neuroprotective , anti-inflammatory or others actions is under investigation",
"Rationale Several investigators implicated role of free radical-mediated pathology in schizophrenia . No study has ever examined the effect of vitamin C with atypical antipsychotics in the treatment of schizophrenia . Objective The aim of this study was to examine the effect of oral vitamin C with atypical antipsychotics on serum malondialdehyde ( MDA ) , plasma ascorbic acid levels , and brief psychiatric rating scale ( BPRS ) score in schizophrenic patients . Method Forty schizophrenic patients participated in a prospect i ve , double-blind , placebo-controlled , noncrossover , 8-week study . The patients with schizophrenia were divided r and omly into placebo and vitamin C group of 20 each . Serum MDA and plasma ascorbic acid were estimated by methods of Nischal and Aye , respectively . Result Increased serum MDA and decreased plasma ascorbic acid levels were found in schizophrenic patients . These levels were reversed significantly after treatment with vitamin C along with atypical antipsychotics compared to placebo with atypical antipsychotics . BPRS change scores at 8 weeks improved statistically significant with vitamin C as compared to placebo . Conclusion Oral supplementation of vitamin C with atypical antipsychotic reverses ascorbic acid levels , reduces oxidative stress , and improves BPRS score , hence both the drugs in combination can be used in the treatment of schizophrenia",
"A r and omized trial ( VITACOG ) in people with mild cognitive impairment ( MCI ) found that B vitamin treatment to lower homocysteine slowed the rate of cognitive and clinical decline . We have used data from this trial to see whether baseline omega-3 fatty acid status interacts with the effects of B vitamin treatment . 266 participants with MCI aged ≥70 years were r and omized to B vitamins ( folic acid , vitamins B6 and B12 ) or placebo for 2 years . Baseline cognitive test performance , clinical dementia rating ( CDR ) scale , and plasma concentrations of total homocysteine , total docosahexaenoic and eicosapentaenoic acids ( omega-3 fatty acids ) were measured . Final scores for verbal delayed recall , global cognition , and CDR sum-of-boxes were better in the B vitamin-treated group according to increasing baseline concentrations of omega-3 fatty acids , whereas scores in the placebo group were similar across these concentrations . Among those with good omega-3 status , 33 % of those on B vitamin treatment had global CDR scores > 0 compared with 59 % among those on placebo . For all three outcome measures , higher concentrations of docosahexaenoic acid alone significantly enhanced the cognitive effects of B vitamins , while eicosapentaenoic acid appeared less effective . When omega-3 fatty acid concentrations are low , B vitamin treatment has no effect on cognitive decline in MCI , but when omega-3 levels are in the upper normal range , B vitamins interact to slow cognitive decline . A clinical trial of B vitamins combined with omega-3 fatty acids is needed to see whether it is possible to slow the conversion from MCI to AD ",
"Objectives Despite the burden of negative symptoms on quality of life in schizophrenic patients , no completely effective treatment has been developed to address such symptoms yet . Abnormalities in oxidative stress pathways have been recently demonstrated to be involved in the pathophysiology of schizophrenia , and a growing interest in antioxidant agents is emerging for targeting negative symptoms of schizophrenia . N-Acetylcysteine ( NAC ) is a potent antioxidant with neuroprotective properties . This study aim ed to evaluate the possible effects of NAC as an adjunct to risperidone in treating negative symptoms of schizophrenia . Material s and Methods In this r and omized , double-blind , placebo-controlled , parallel-group study , 42 patients with chronic schizophrenia and a score of 20 or greater on the negative subscale of positive and negative syndrome scale ( PANSS ) were enrolled in the active phase of their illness . The participants were equally r and omized to receive NAC ( up to 2 g/d ) or placebo , in addition to risperidone ( up to 6 mg/d ) for 8 weeks . The participants were rated using PANSS every 2 weeks , and the decrease of PANSS negative subscale score was considered as our primary outcome . Results By the study end point , NAC-treated patients showed significantly greater improvement in the PANSS total ( P = 0.006 ) and negative subscale ( P placebo group , but this difference was not significant for positive and general psychopathology subscales . There was no significant difference between the 2 groups in the frequency of adverse effects . Conclusions NAC add-on therapy showed to be a safe and effective augmentative strategy for alleviating negative symptoms of schizophrenia",
"Short-term clinical trials of omega-3 polyunsaturated fatty acids ( n-3 PUFA ) as add-on therapy in patients with schizophrenia revealed mixed results . The majority of these studies used an 8- to 12-week intervention based on ethyl-eicosapentaenoic acid . A r and omized placebo-controlled trial was design ed to compare the efficacy of 26-week intervention , composed of either 2.2 g/day of n-3 PUFA , or olive oil placebo , with regard to symptom severity in first-episode schizophrenia patients . Seventy-one patients ( aged 16 - 35 ) were enrolled in the study and r and omly assigned to the study arms . The primary outcome measure of the clinical evaluation was schizophrenia symptom severity change measured by the Positive and Negative Syndrome Scale ( PANSS ) . Mixed models repeated measures analysis revealed significant differences between the study arms regarding total PANSS score change favouring n-3 PUFA ( p = 0.016 ; effect size ( ES ) = 0.29 ) . A fifty-percent improvement in symptom severity was achieved significantly more frequently in the n-3 PUFA group than in the placebo group ( 69.4 vs 40.0 % ; p = 0.017 ) . N-3 PUFA intervention was also associated with an improvement in general psychopathology , measured by means of PANSS ( p = 0.009 ; ES = 0.32 ) , depressive symptoms ( p = 0.006 ; ES = 0.34 ) , the level of functioning ( p = 0.01 ; ES = 0.31 ) and clinical global impression ( p = 0.046 ; ES = 0.29 ) . The findings suggest that 6-month intervention with n-3 PUFA may be a valuable add-on therapy able to decrease the intensity of symptoms and improve the level of functioning in first-episode schizophrenia patients",
"Intervention studies of n-3 polyunsaturated fatty acids ( n-3 PUFA ) as add-on therapy in patients with schizophrenia have not examined changes in oxidative stress . A r and omized placebo-controlled trial of a 26-week intervention composed of 2.2g/day of n-3 PUFA was found to reduce symptom severity in first-episode schizophrenia patients . The present study is an extension of our previous report , whose secondary aim was to assess the association between the clinical effect of n-3 PUFA and changes in oxidative stress indices . Seventy-one patients aged 16 - 35 were enrolled in the study and r and omly assigned to the study arms . Total plasma antioxidant capacity and 8-epi-isoprostane F2α content were assessed at baseline and at weeks 8 and 26 of the study as secondary outcome measures . Significant changes in oxidative stress indices favouring the intervention group were observed : decreases in 8-isoprostane F2α ( p and increases in total plasma antioxidant capacity ( p between changes in clinical scores relevant to symptom severity and changes in oxidative indices were observed . The results of the present study hence suggest that the efficacy of a six-month intervention with n-3 PUFA observed in first-episode schizophrenia may be related to improvement in oxidative stress indices ",
"We used magnetic resonance imaging to examine the effect of ethyl-eicosapentaenoic acid ( E-EPA ) on hippocampal T(2 ) relaxation time in first episode psychosis patients at baseline and after 12 weeks of follow-up . There was an increase in T(2 ) in the placebo group but not in the E-EPA group , suggesting a neuroprotective effect of E-EPA treatment . In addition , the smaller the increase in T(2 ) , the greater the improvement in negative symptoms"
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41174da8-06ff-11f0-808a-c43d1ab1c353
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QUESTION In people who have been discharged from hospital after a total hip replacement , do rehabilitation exercises directed by a physiotherapist improve strength , gait , function and quality of life ? Are these exercises as effective in an unsupervised home-based setting as they are in a supervised outpatient setting ? DESIGN Systematic review with meta- analysis of r and omised trials . PARTICIPANTS Adult patients after elective total hip replacement . INTERVENTION Physiotherapist-directed rehabilitation exercises after discharge from hospital following total hip replacement . OUTCOME MEASURES Hip and knee strength , gait parameters , functional measures , and quality of life . RESULTS Five studies comprising 234 participants were included in the review . Sufficient data for meta- analysis were only obtained for hip and knee strength , gait speed and cadence . Physiotherapy rehabilitation improved hip abductor strength by a mean of 16Nm ( 95 % CI 10 to 22 ) , gait speed by 6 m/min ( 95 % CI 1 to 11 ) and cadence by 20 steps/min ( 95 % CI 8 to 32 ) . Favourable but non-significant improvements in strength were noted for other muscle groups at the hip and knee . Function and quality of life could not be meta-analysed due to insufficient data and heterogeneity of measures , but functional measures tended to favour the physiotherapy rehabilitation group . Most outcomes were similar between outpatient and home-based exercise programs . CONCLUSION Physiotherapy rehabilitation improves hip abductor strength , gait speed and cadence in people who have been discharged from hospital after total hip replacement . Physiotherapist-directed rehabilitation exercises appear to be similarly effective whether they are performed unsupervised at home or supervised by a physiotherapist in an outpatient setting
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"OBJECTIVE To examine the physical function , gait , and quality of life of patients after total hip replacement ( THR ) r and omly assigned to either a targeted home- or center-based exercise program . DESIGN R and omized controlled trial . SETTING Rehabilitation research center in Australia . PARTICIPANTS Twenty-three patients with unilateral THR were r and omly assigned to a supervised center-based exercise group ( n=11 ) or an unsupervised home-based exercise group ( n=12 ) . INTERVENTION The center-based group completed an 8-week targeted exercise program while under the direct supervision of a physiotherapist . After initial instruction , the home-based group completed the 8-week targeted exercise program at home without further supervision . MAIN OUTCOME MEASURES Quality of life , physical function , and spatiotemporal measures of gait . RESULTS No significant interaction ( group by time ) or main effects of grouping were found . Within each group , quality of life , and stair climbing improved significantly ( P Up & Go test and 6-minute walk test performances ( P Walking speed increased by 16 cm/s ( P cadence by 8 steps/min ( P step length by 4.7 cm ( P double-support time reduced by a factor of 16 % . Step length symmetry showed significant improvement ( P Step length differential between the affected and unaffected limbs reduced from 4.0 to 2.7 cm . CONCLUSIONS The targeted strengthening program was effective for both the home- and center-based groups . No group differences were found in the majority of the outcome measures . This finding is important because it shows that THR patients can achieve significant improvements through a targeted strengthening program delivered at a center or at home",
"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",
"UNLABELLED Coulter CL , Weber JM , Scarvell JM . Group physiotherapy provides similar outcomes for participants after joint replacement surgery as 1-to-1 physiotherapy : a sequential cohort study . OBJECTIVES To compare effectiveness and time efficiency of physiotherapy rehabilitation provided within a group with an individualized program provided at home for improving participants ' outcomes after total joint replacement surgery . DESIGN Quasiexperimental sequential cohort trial with 12-week follow-up . SETTING A tertiary acute care hospital . PARTICIPANTS Consecutive patients ( N=51 ) having hip or knee replacement surgery in an 8-month period and who were able to weight-bear postoperatively . INTERVENTIONS The first group admitted to the study entered the exercise group , and patients in the following 4 months entered the home physiotherapy group . MAIN OUTCOME MEASURES Primary outcome measures included the Western Ontario McMaster 's University Osteoarthritis Index ( WOMAC ) , Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) , Timed Up & Go ( TUG ) test , and knee range of motion ( ROM ) . Secondary measures included the 6-m walk test and a patient evaluation question naire . Staff time costs were recorded . Outcomes were recorded preoperatively or at hospital discharge , and 5 and 12 weeks postoperatively . RESULTS There was no difference between the 2 groups for either the WOMAC or SF-36 scores , 6-m walk test , TUG test , or ROM measures at 12 weeks ( P>.05 ) , although both groups of patients improved between hospital discharge and 12 weeks . The class group accessed more frequent physiotherapy than the home group ( mean , 7.5 and 3.96 visits , respectively ) . The physiotherapist 's time was less per patient per visit for the class group ( mean , 27min direct and 10min indirect ) than for the home visits ( mean , 38min direct and 26min indirect ) . CONCLUSIONS This trial suggests that the class-based exercise rehabilitation was the most efficient method of delivery of the physiotherapy service , without cost to patient outcomes",
"OBJECTIVE To determine the minimal perceptible clinical improvement ( MPCI ) in patients with osteoarthritis ( OA ) with the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) question naire , and patient and investigator global assessment of disease status in r and omized clinical trials for treatment of OA . METHODS Subjects with OA of the knee or hip were r and omized to receive either rofecoxib 12.5 or 25 mg once daily , ibuprofen 800 mg 3 times daily , or placebo for 6 weeks . The WOMAC and global assessment s were completed at baseline and Weeks 2 , 4 , and 6 . A patient global assessment of response to therapy ( 0 to 4 scale ) was used to \" anchor \" the WOMAC scores . MPCI was defined as the difference in mean change from baseline in WOMAC ( 100 mm normalized visual analog scale , VAS ) between patients with 0 = \" None \" global response to therapy and patients with 1 = \" Poor \" global response to therapy . RESULTS MPCI was determined to be 9.7 , 9.3 , and 10.0 mm for the WOMAC pain , physical function and stiffness subscales , respectively , and 11.1 mm for WOMAC question 1 : Pain walking on a flat surface . The MPCI for the investigator was 0.4 with investigator assessment of disease status reported on a 0 to 4 Likert scale . Of note , the estimated MPCI for the WOMAC and investigator globals were similar irrespective of treatment , sex , age , or geographic region . CONCLUSION In this analysis , mean changes of roughly 9 to 12 mm ( 100 mm normalized VAS ) on WOMAC scales were perceptible changes to patients with hip and knee OA . A mean decrease of 0.4 in global disease status ( 0 to 4 Likert scale ) as assessed by the investigator corresponded to the patients ' MPCI . Underst and ing the minimal perceptible differences may permit a better assessment of the clinical relevance of therapeutic interventions in OA",
"Organized physiotherapy starting two months after uncomplicated total hip replacements for primary arthrosis did not improve the rehabilitation . Six months after surgery there were no significant differences between 14 patients with and 16 patients without physiotherapy regarding improvement of passive hip motion , or hip or knee muscle strength of the operated limb . Neither were there any differences in walking ability or activities of daily living",
"OBJECTIVE To investigate the effects of a late-phase exercise program for patients who underwent total hip arthroplasty ( THA ) 4 to 12 months earlier . DESIGN A single-blind , r and omized controlled trial . SETTING Exercises were performed in subjects ' homes . Exercise instruction and measurements taken before and after the trial were performed in an outpatient research and treatment center . PARTICIPANTS Convenience sample of 34 adults 4 to 12 months post-THA r and omly allocated to experimental or control groups . Twenty-eight subjects completed the study . INTERVENTION An 8-week , hip-exercise intervention , during which the control group received basic isometric and active range of motion exercises ; the experimental group received strength and postural stability exercises . MAIN OUTCOME MEASURES Score on the 12-Item Hip Question naire ; fear of falling ; hip flexor , extensor , abductor , and knee extensor muscle torque ; and postural stability in single stance . RESULTS There was a statistically significant improvement in all measures of self-perceived function , muscle strength ( hip flexors , 24.4 % ; hip extensors , 47.8 % ; hip abductors , 41.2 % ; knee extensors , 23.4 % ) , and postural stability ( 36.8 % ) in the experimental group and no significant change in the control group . Neither group had statistically significant changes in fear of falling measures . CONCLUSIONS An exercise program emphasizing weight bearing and postural stability significantly improved muscle strength , postural stability , and self-perceived function in patients 4 to 12 months after THA",
"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",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"OBJECTIVE To study the effect of a home program of physical therapy . DESIGN Nonr and omized control trial . SETTING Home based . PATIENTS Subjects had total hip arthroplasty ( THA ) for hip osteoarthritis ( hip-OA ) without THA failure , or cardiopulmonary , neurological , or cognitive problems . Twenty-three subjects ( mean age 63.4 years ; mean post-THA period 793 days , 6 to 48 months ) were divided into 3 groups matching with age , gender , and postoperative periods . INTERVENTION The 6-week home program included range of motion ( ROM ) exercises , and low resistance isometric and eccentric exercises of hip abductors . Physical therapists prescribed ROM and isometric exercises for group A , all programs for group B , and no programs for the control group . The programs were modified every 2 weeks as necessary . MAIN OUTCOME MEASURE Hip ROM , maximum isometric hip abduction torque measured by Cybex II , gait speed , and cadence were evaluated . RESULTS The practice ratio of the program was about 70 % for both groups . Maximum isometric torque improved in the THA side of group A ( p Gait speed and cadence also improved significantly . No correlation coefficient existed between practice days and the improvement ratio of the maximum torque . CONCLUSION The home program was effective in long-term post-THA",
"Objective : To evaluate the effect of home versus in-hospital exercise ( under supervision ) programmes on hip strength , gait speed and cadence in patients with total hip arthroplasty at least one year after operation . Setting : Physical therapy and rehabilitation department . Subjects : Twenty-six patients who had had a total hip arthroplasty operation 12—24 months prior to the study were enrolled . Interventions : The patients were r and omized into three groups : group 1 patients were assigned a home exercise programme , group 2 patients exercised under physiotherapist supervision in hospital , and group 3 served as the control group , with no specific intervention . The study duration was six weeks . Main measures : Maximum isometric abduction torque of operated hip muscle , gait speed and cadence were measured before and after the study . Results : Maximum isometric abduction torques of the hip abductor muscles improved in groups 1 and 2 , but not in group 3 ( 30 ± 12 to 38 ± 11 ft.lb in group 1 , 18 ± 10 to 30 ± 9.8 ft.lb in group 2 ) . Gait speed improved from 67.8 ± 23 to 74.35 ± 24 m/min in group 1 , from 48.53 ± 4 to 56.7 ± 5 m/min in group 2 and from 58.01 ± 12 to 59.8 ± 14 m/min in group 3 . Cadence also improved , from 97.7 ± 18 to 111 ± 17 steps/min in group 1 , from 90.75 ± 6 to 104.75 ± 7 steps/min in group 2 , and from 87 ± 16 to 88.22 ± 16 steps/min in group 3 . When the three groups were compared , group 2 showed the best improvement ( P = 0.006 ) only in maximum isometric abduction torque . Conclusion : Our findings suggest that both home and supervised exercise programmes are effective one year after total hip arthroplasty . Home exercise programmes with close follow-up could be recommended"
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41174de4-06ff-11f0-808a-c43d1ab1c353
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Zinc plays critical roles during embryogenesis , fetal growth , and milk secretion , which increase the zinc need for pregnancy and lactation . Increased needs can be met by increasing the dietary zinc intake , along with making homeostatic adjustments in zinc utilization . Potential homeostatic adjustments include changes in circulating zinc , increased zinc absorption , decreased zinc losses , and changes in whole body zinc kinetics . Although severe zinc deficiency during pregnancy has devastating effects , systematic review s and meta- analysis of the effect of maternal zinc supplementation on pregnancy outcomes have consistently shown a limited benefit . We hypothesize , therefore , that zinc homeostatic adjustments during pregnancy and lactation improve zinc utilization sufficiently to provide the increased zinc needs in these stages and , therefore , mitigate immediate detrimental effects due to a low zinc intake . The specific questions addressed are the following : How is zinc utilization altered during pregnancy and lactation ? Are those homeostatic adjustments influenced by maternal zinc status , dietary zinc , or zinc supplementation ? These questions are addressed by critically review ing results from published human studies on zinc homeostasis during pregnancy and lactation carried out in different population s worldwide
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"BACKGROUND Adjustments in zinc absorption and endogenous excretion maintain zinc homeostasis in nonpregnant adults fed low-zinc diets . The effects on zinc homeostasis of a low zinc intake during pregnancy and lactation have not been described in a longitudinal study . OBJECTIVE We examined longitudinal changes in fractional zinc absorption ( FZA ) and zinc kinetics in 10 healthy Brazilian women who habitually consumed a marginal zinc diet ( approximately 9 mg Zn/d ) . DESIGN Zinc status was measured at 10 - 12 ( early pregnancy ; EP ) and 34 - 36 ( late pregnancy ; LP ) wk of pregnancy and at 7 - 8 wk after delivery ( early lactation ; EL ) . Zinc kinetics and FZA were studied by using stable isotopic tracers . RESULTS Zinc intake averaged 9 + /- 3 mg/d throughout the study . FZA increased from 29 + /- 6 % at EP to 43 + /- 10 % at LP and to 39 + /- 13 % at EL ( P FZA was inversely related to plasma zinc at EL ( r = -0.73 , P = 0.02 ) and LP ( r = -0.72 , P = 0.07 ) . Plasma zinc mass was 23 % greater at LP than at EP or EL ( P amount of zinc ( mg/d ) that fluxed between plasma and the most-rapidly-turning-over extravascular pool was 53 % greater at LP than at EP or EL ( P zinc flux between plasma and the less-rapidly-turning-over zinc pool at EL was 27 % greater than that at EP or LP , but this difference was not significant . CONCLUSIONS FZA increased significantly in women with marginal zinc intakes during pregnancy and lactation ; the increase was higher in women with low plasma zinc . Plasma zinc was distributed into a different exchangeable pool at LP than at EL",
"Prenatal iron supplements may adversely influence zinc absorption during pregnancy . To examine the impact of prenatal iron supplements on supplemental zinc absorption , fractional zinc absorption was measured in 47 pregnant Peruvian women during the third trimester of pregnancy ( 33 + /- 1 wk gestation ) . Of these 47 women , 30 received daily prenatal supplements from wk 10 - 24 of pregnancy until delivery . Supplements contained 60 mg of Fe and 250 microg of folate without [ iron group ( Fe ) , n = 16 ] or with [ iron and zinc supplemented group ( Fe + Zn ) , n = 14 ] 15 mg of Zn . The remaining 17 women [ unsupplemented control group ( C ) ] received no prenatal supplementation . Zinc concentrations were measured in plasma , urine and cord blood and percentage zinc absorption was determined following dosing with oral ( (67)Zn ) and intravenous ( (70)Zn ) stable zinc isotopes . Percentage zinc absorption was significantly lower than controls in fasting women receiving iron- containing prenatal supplements ( 20.5 + /- 6.4 vs. 20.2 + /- 4.6 vs. 47.0 + /- 12.6 % , Fe , Fe + Zn and C groups , respectively , P : Plasma zinc concentrations were also significantly lower in the Fe group compared to the C group ( 8.2 + /- 2.2 vs. 9.2 + /- 2.2 vs. 10.9 + /- 1 . 8 micromol/L , Fe , Fe + Zn and C groups , respectively , P : = 0.002 ) , and cord zinc concentrations were significantly related to maternal plasma Zn levels ( y = 6.383 + 0.555x , r = 0.486 , P : = 0.002 ) . The inclusion of zinc in prenatal supplements may reduce the potential for iron supplements to adversely influence zinc status in population s at risk for deficiency of both these nutrients",
" Postpartum lactating ( n = 12 ) and nonlactating ( n = 11 ) women and never pregnant women ( n = 14 ) collected urine sample s and diet records 2 d each month for 6 mo to determine whether postpartum women conserved urinary calcium , magnesium , or zinc . Mean daily excretions were analyzed by repeated- measures analysis of variance and covariance to assess group and time effects . Lactating women excreted less urinary calcium ( 1 - 6 mo ) than never pregnant ( n = 8) and nonlactating ( n = 4 ) women who did not use oral contraceptives ( P urinary calcium than the other women ( P Lactating women excreted less urinary zinc ( 1 - 6 mo ) than did control and non-lactating women ( P depress urinary calcium for > or = 2 mo and urinary zinc < or = 6 mo postpartum",
"To estimate the effect of maternal zinc deficiency on pregnancy outcomes , we conducted a zinc supplementation trial in an urban shantytown in Lima , Peru , a population with habitual low zinc intakes . Beginning at 10 - 24 wk gestation , 1295 mothers were r and omly assigned to receive prenatal supplements containing 60 mg iron and 250 ( g folate , with or without 15 mg zinc . Women were followed up monthly during pregnancy . At birth , newborn weight was recorded , and crownheel length , head circumference and other circumferences and skinfold thicknesses were assessed on d 1 . At delivery , 1016 remained in the study ; duration of pregnancy was known for all women , and birth weight information was available for 957 newborns . No differences were noted in duration of pregnancy ( 39.4 + /- 2.2 vs. 39 . 5 + /- 2.0 wk ) or birth weight ( 3267 + /- 461 vs. 3300 + /- 498 g ) by prenatal supplement type ( iron + folate + zinc vs. iron + folate ; P > 0.05 ) , and there were no differences in the rates of preterm ( post-term ( > 42 wk ) delivery , low birth weight ( high birth weight ( > 4000 g ) . Finally , there were no differences by prenatal supplement type in newborn head circumference , crownheel length , chest circumference , mid-upper arm circumference , calf circumference or skinfold thickness at any of three sites . Adjustment for covariates and confounding factors did not alter these results . Adding zinc to prenatal iron and folate tablets did not affect duration of pregnancy or size at birth in this population",
"BACKGROUND Maternal zinc deficiency during pregnancy may be widespread among women in developing countries , but few data are available on whether prenatal zinc supplementation improves maternal and neonatal zinc status . OBJECTIVE We studied whether maternal zinc supplementation improved the zinc status of mothers and neonates participating in a supplementation trial in a shantytown in Lima , Peru . DESIGN Beginning at gestation week 10 - 24 , 1295 mothers were r and omly assigned to receive prenatal supplements containing 60 mg Fe and 250 microg folate , with or without 15 mg Zn . Venous blood and urine sample s were collected at enrollment , at gestation week 28 - 30 , and at gestation week 37 - 38 . At birth , a sample of cord vein blood was collected . We measured serum zinc concentrations in 538 women , urinary zinc concentrations in 521 women , and cord zinc concentrations in 252 neonates . RESULTS At 28 - 30 and 37 - 38 wk , mothers receiving zinc supplements had higher serum zinc concentrations than mothers who did not receive zinc ( 8.8 + /- 1.9 compared with 8.4 + /- 1.5 micromol/L and 8.6 + /- 1.5 compared with 8.3 + /- 1.4 micromol/L , respectively ) . Urinary zinc concentrations were also higher in mothers who received supplemental zinc ( P cord zinc concentrations than neonates of mothers who did not receive zinc ( 12.7 + /- 2.3 compared with 12.1 + /- 2.1 micromol/L ) . Despite supplementation , maternal and neonatal zinc concentrations remained lower than values reported for well-nourished population s. CONCLUSION Adding zinc to prenatal iron and folate tablets improved maternal and neonatal zinc status , but higher doses of zinc are likely needed to further improve maternal and neonatal zinc status in this population",
"BACKGROUND Little is known about how maternal zinc intake influences growth in utero and in postnatal life in humans . OBJECTIVE We aim ed to assess the effect of maternal zinc supplementation during pregnancy on infant growth through age 1 y. DESIGN A double-blind , r and omized controlled trial of prenatal zinc supplementation was conducted from 1995 to 1997 in Lima , Peru . Women ( n = 1295 ) were enrolled at 15.6 + /- 4.6 wk gestation and assigned to receive daily supplements with zinc ( 15 mg Zn + 60 mg Fe + 250 microg folic acid ) or without zinc ( 60 Fe + 250 microg folic acid ) through pregnancy to 1 mo after delivery . At birth , 546 infants were followed for 12 mo to assess growth . Anthropometric measures of body size and composition were collected monthly , and morbidity and dietary intake surveillance was carried out weekly . RESULTS No differences in maternal socioeconomic characteristics by treatment group or follow-up period were found . Infants born to mothers prenatally supplemented with zinc had significantly ( P average growth measures beginning in month 4 and continuing through month 12 . In longitudinal regression modeling , prenatal zinc was associated with greater weight ( by 0.58 + /- 0.12 kg ; P calf circumference ( by 1.01 + /- 0.21 cm ; P chest circumference ( by 0.60 + /- 0.20 cm ; P = 0.002 ) , and calf muscle area ( by 35.78 + /- 14.75 mm(2 ) ; P = 0.01 ) after adjustment for a range of covariates . No effect was observed for linear growth . CONCLUSION Maternal zinc supplementation in this population was associated with offspring growth , which is suggestive of lean tissue mass accretion",
"BACKGROUND There is a major increase in endogenous zinc excretion , specifically via the mammary gl and , in early human lactation . Whereas fractional absorption of dietary zinc has been reported to increase in early human lactation , it is not known to what extent adaptive mechanisms may maintain zinc homeostasis , especially when dietary zinc intake is relatively low . OBJECTIVE The objective of this study was to quantitate major variables of zinc homeostasis during early lactation in subjects from a population whose habitual dietary zinc intake is low . DESIGN We studied 18 free-living lactating women from a rural community of northeast China whose infants were exclusively breast-fed . The subjects were studied at approximately 2 mo of lactation with use of stable isotopes of zinc and metabolic collection techniques . Milk volume was measured with use of a deuterium enrichment method . RESULTS The mean ( + /-SD ) secretion of zinc in milk was 2.01 + /- 0.97 mg/d , the intake of zinc was 7.64 + /- 1.61 mg/d , and the fractional absorption of zinc was 0.53 + /- 0.09 , for a total daily zinc absorption of 4.00 + /- 0.71 mg/d . Endogenous zinc excretion in urine and feces was 0.30 + /- 0.10 and 1.66 + /- 0.97 mg/d , respectively . CONCLUSIONS Zinc balance , including zinc secreted in breast milk , was maintained at approximately 2 mo of lactation in women whose habitual diet was low in zinc . Homeostasis was achieved by high fractional absorption of zinc and intestinal conservation of endogenous fecal zinc",
"Dietary zinc ( Zn ) intake and selected biochemical indices of Zn status were studied longitudinally at monthly intervals in 46 pregnant middle-income women , 10 of whom received a daily supplement of 15 mg Zn . Mean dietary Zn intake for the nonsupplemented subjects ( group A ) was 11.3 + /- 4.1 mg/day ( 56 % of the Recommended Dietary Allowances ) , and for the Zn-supplemented subjects ( group B ) was 21.7 mg/day ( 109 % of the Recommended Dietary Allowance ) , including an average intake of 11.1 mg/day as supplemental Zn . The mean plasma Zn concentration of group A at 2 months gestation , 71.4 + /- 9.8 micrograms/dl , was 17 % lower than that of nonpregnant control women , and continued to decline significantly ( p less than 0.01 ) between 2 and 10 months gestation . Plasma Zn of group B did not differ significantly from group A at any stage of gestation . Mean serum alkaline phosphatase activity of group B was higher than that of group A at 7 of 8 months studied ( p less than 0.05 ) . The level of prenatal iron supplementation in group A was negatively correlated with alkaline phosphatase activity and plasma Zn in the 2nd and 3rd trimesters , respectively . It is concluded that an early and progressive decline in plasma Zn which is not influenced by Zn intake occurs during gestation . Tentative st and ards for lower limits of normal at monthly intervals have been suggested . The higher alkaline phosphatase activity of group B compared with group A suggested that the dietary Zn intake of the latter was suboptimal . Prenatal supplemental iron may adversely affect maternal Zn status",
"Forty lactating women were r and omly assigned to four treatment groups . Beginning at 1-d postpartum the women in each group received a daily vitamin-mineral supplement for 9 mo . The treatments differed only in the amount of vitamin B-6 ( 0.5 or 4.0 mg pyridoxine ) and zinc ( 0 or 25 mg ) included in the supplements . The 4.0-mg pyridoxine supplements significantly increased plasma total vitamin B-6 , plasma pyridoxal phosphate ( PLP ) , and milk total vitamin B-6 , thus showing that maternal intake exerts a significant effect on vitamin B-6 concentration in milk . There was no effect of vitamin B-6 intake on plasma , erythrocyte , or milk zinc concentration . The 25-mg zinc supplement also had no effect on plasma , erythrocyte , or milk zinc concentration , suggesting that maternal zinc intake is not a major regulator of milk zinc concentration",
"We studied zinc nutrition in exclusively breast-fed infants whose growth deviated from the norm . Their number fell from 200 at birth to 116 at the age of 6 months and 36 at the age of 9 months . The mothers received 0 , 20 , or 40 mg Zn+ + as sulfate daily . Breast milk intake and concentrations of zinc in milk as well as in maternal and infant serum were measured . Individual zinc concentrations in milk showed channeling . The 20-mg supplement had no effect on the parameters measured . In contrast , 40 mg increased the maternal serum zinc concentration by 2 months and slowed the normal decline of milk zinc concentration by 6 months . Maternal supplementation had no effect on infant serum concen-trations ; they remained lower than adult levels throughout the 1st year of life . Zinc intake was low ( about one-tenth of RDA ) , but it seemed to be adequate ; the serum concentrations of the infants were stable after the age of 2 months . Low zinc concentrations in serum were not associated with impaired growth . On the contrary , the infants with the highest rates of growth had the lowest zinc concentrations . The infant serum zinc concentrations were channeled , but they were also influenced by the zinc intake . Reference values for breast-fed infants are given",
"OBJECTIVE To evaluate whether zinc supplementation during pregnancy is associated with an increase in birth weight . DESIGN A r and omized double-blind placebo-controlled trial . SETTING Outpatient clinic and delivery service at the University of Alabama at Birmingham . PATIENTS Five hundred eighty medically indigent but otherwise healthy African-American pregnant women with plasma zinc levels below the median at enrollment in prenatal care , r and omized at 19 weeks ' gestational age . Women were subdivided by the population median body mass index of 26 kg/m2 into two groups for additional analyses . INTERVENTION Women who were taking a non-zinc-containing prenatal multivitamin/mineral tablet were r and omized to receive either a daily dose of 25 mg of zinc or a placebo until delivery . MAIN OUTCOME MEASURES Birth weight , gestational age at birth , and head circumference at birth . RESULTS In all women , infants in the zinc supplement group had a significantly greater birth weight ( 126 g , P = .03 ) and head circumference ( 0.4 cm , P = .02 ) than infants in the placebo group . In women with a body mass index less than 26 kg/m2 , zinc supplementation was associated with a 248-g higher infant birth weight ( P = .005 ) and a 0.7-cm larger infant head circumference ( P = .007 ) . Plasma zinc concentrations were significantly higher in the zinc supplement group . CONCLUSIONS Daily zinc supplementation in women with relatively low plasma zinc concentrations in early pregnancy is associated with greater infant birth weights and head circumferences , with the effect occurring predominantly in women with a body mass index less than 26 kg/m2",
"Women in different trimesters of pregnancy ( Group B ; n = 106 ) were administered 200 mg zinc sulphate ( elemental Zn 45 mg ) orally/day from the day of reporting till delivery . Untreated group of 62 served as control . Levels of zinc in maternal serum , umbilical cord blood serum , and urine were estimated . Pregnancy outcome was assessed in terms of incidence of prematurity , IUGR , birth weight ; apgar score and gestational age . Serum zinc levels in Gp . A declined significantly from 113.00 + /- 2.80 ug/dl in I trimester to 83.78 + /- 2.20 ug/dl in III ( P zinc supplementation ( Gp . B ) serum zinc levels increased significantly from 109.70 + 3.23 micrograms/dl to 205.40 + /- 4.47 micrograms/dl ( P Urinary excretion of zinc in Gp . A declined significantly with increase in the period of gestation . However in Gp . B , elimination of Zn increased significantly in proportion with the serum levels ( P cord blood serum zinc level was normal irrespective of maternal serum Zn levels . Following oral Zn supplementation , levels increased significantly from below 127.0 micrograms/dl to above 158.0 micrograms/dl in Gp . B ( P Maternal serum and cord blood serum zinc ratios were fairly constant in Gp . A as well as in Gp . B. Birth weight of babies born with Zn supplementation was significantly higher than control and was related to duration of oral zinc supplementation ( P age of babies in Gp . B was significantly higher than respective controls when Zn supplementation was given for more than 3 months ( P < 0.01 ) , and was related to duration of zinc therapy ( P < 0.05 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Effects of stage of lactation , nutrient intake , and cultural differences on the composition of human milk were examined during the first 6 mo of lactation in American and Egyptian women . In both population groups zinc levels in milk decreased from 1 to 6 months of lactation . American women supplemented with Zn had higher levels of Zn in their milk than did unsupplemented American or Egyptian women . Concentrations of calcium and magnesium were not significantly different in milk of American and Egyptian women except at month 6 of lactation . Ca levels in milk of both population groups increased from 1 to 2 - 3 mo of lactation and then decreased at 6 mo ; Mg concentrations increased from 1 to 3 mo and then reached a plateau . Similarities in the longitudinal decrease observed in Zn levels of milk in Zn supplemented and unsupplemented subjects suggested physiological regulation",
"The effects of a zinc supplement on maternal zinc status and milk zinc concentrations through > or = 7 mo of lactation were examined . Seventy-one lactating women received either a daily 15-mg zinc supplement ( ZS , n = 40 ) or placebo ( NZS , n = 31 ) started by 2 wk postpartum in a double-blind , r and omized design . Overall mean zinc intakes were 13.0 + /- 3.4 mg/d for the NZS group and 25.7 + /- 3.9 mg/d ( including supplement ) for the ZS group . Plasma zinc concentrations of the ZS group were significantly higher than those of the NZS group ( P = 0.05 ) . Milk zinc concentrations declined significantly over the course of the study for all subjects but were not affected by zinc supplementation . The mean dietary zinc intake observed in the nonsupplemented group was adequate to maintain normal maternal zinc status and milk zinc concentrations through > or = 7 mo lactation . Similar controlled intervention trials in less well-nourished population s will be required to assess the impact of lower zinc intakes on milk zinc concentrations"
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OBJECTIVES Uncertainty remains about whether personal financial incentives could achieve sustained changes in health-related behaviors that would reduce the fast-growing global non-communicable disease burden . This review aims to estimate whether : i. financial incentives achieve sustained changes in smoking , eating , alcohol consumption and physical activity ; ii . effectiveness is modified by ( a ) the target behavior , ( b ) incentive value and attainment certainty , ( c ) recipients ' deprivation level . METHODS Multiple sources were search ed for trials offering adults financial incentives and assessing outcomes relating to pre-specified behaviors at a minimum of six months from baseline . Analyses included r and om-effects meta-analyses and meta-regressions grouped by timed endpoints . RESULTS Of 24,265 unique identified articles , 34 were included in the analysis . Financial incentives increased behavior-change , with effects sustained until 18months from baseline ( OR : 1.53 , 95 % CI 1.05 - 2.23 ) and three months post-incentive removal ( OR : 2.11 , 95 % CI 1.21 - 3.67 ) . High deprivation increased incentive effects ( OR : 2.17 ; 95 % CI 1.22 - 3.85 ) , but only at > 6 - 12months from baseline . Other assessed variables did not independently modify effects at any time-point . CONCLUSIONS Personal financial incentives can change habitual health-related behaviors and help reduce health inequalities . However , their role in reducing disease burden is potentially limited given current evidence that effects dissipate beyond three months post-incentive removal
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"Objective : We sought to assess whether either a low-cost educational intervention or small monetary incentive is more effective than usual care in lowering low-density lipoprotein ( LDL ) cholesterol among employees . Methods : Employees with an LDL-C > 130 mg/dL were eligible . After receiving on-line educational material s , subjects were assigned to three groups : group 1 received $ 100 if they reduced their LDL-C by 15 % within 6 months , group 2 participated in a multi-disciplinary educational program , and group 3 received no further intervention . Results : In total , 171 employees participated . Baseline mean LDL-C was 156 mg/dL. Approximately 6 months after r and omization , mean LDL-C was reduced 17.9 mg/dL ( 11.3 % ) in group 1 , 17.9 mg/dL ( 11.5 % ) in group 2 , and 5.5 mg/dL ( 3.5 % ) in group 3 . Reductions in groups 1 and 2 were statistically superior to group 3 ( P = 0.02 ) . Conclusions : Both an employer directed low-cost educational program and small monetary incentives similarly lowered LDL-C compared with usual care",
"INTRODUCTION The efficacy of contingency-management ( CM ) and motivational enhancement therapy ( MET ) for college student smoking cessation was examined . METHODS Nontreatment-seeking daily smokers ( N = 110 ) were r and omly assigned to 3 weeks of CM versus noncontingent reinforcement ( NR ) and to three individual sessions of MET versus a relaxation control in a 2 x 2 experimental design . Expired carbon monoxide ( CO ) sample s were collected twice daily for 3 weeks . Participants earned 5 US dollars for providing each sample ; additionally , those r and omized to CM earned escalating monetary rewards based on CO reductions ( Week 1 ) and smoking abstinence ( Weeks 2 - 3 ) . RESULTS Compared with NR , CM result ed in significantly lower CO levels and greater total and consecutive abstinence during the intervention . Those in the CM and MET groups reported greater interest in quitting smoking posttreatment , but rates of confirmed abstinence at follow-up were very low ( 4 % at 6-month follow-up ) and did not differ by group . DISCUSSION Findings support the short-term efficacy of CM for reducing smoking among college students . Future research should explore enhancements to CM in this population , including a longer intervention period and the recruitment of smokers who are motivated to quit",
"BACKGROUND The relation between cigarette smoking and several malignancies is still unclear . We examined the association of cigarette smoking with death attributed to 15 cancer sites , 7 of which are regarded as having an uncertain relation with tobacco . PATIENTS AND METHODS The original Whitehall study is a prospect i ve cohort of 17 363 London-based male government employees ( age 40 - 69 years ) who were examined in the late 1960s and then followed up for a maximum of 38 years . RESULTS Following adjustment for demographic characteristics , risk factors , and prevalent disease , established positive cigarette smoking -- cancer gradients were confirmed for carcinoma of the lung , stomach , pancreas , bladder , upper aero-digestive ( including oesophagus ) , and liver , and for myeloid leukaemia . Among the cancers of uncertain relation with smoking , mortality rates for malignancy of the colon , rectum and prostate and for lymphatic leukaemia were elevated in current and /or former smokers . There was essentially no apparent relation between smoking and mortality from carcinoma of the brain or from lymphoma . CONCLUSION In this study , cigarette smoking appears to be a risk factor for several malignancies of previously unclear association with tobacco use ",
"Exercise is the best predictor of long-term weight loss . This study evaluated two strategies for improving exercise adherence and long-term weight loss in obese out patients . Obese men and women ( N = 193 ) were r and omized to 1 of 5 treatment groups for 18 months : st and ard behavior therapy ( SBT ) ; SBT with supervised walks ( SW ) 3 times per week ; SBT + SW with personal trainers ( PT ) , who walked with participants , made phone reminders , and did make-up SW ; SBT + SW with monetary incentives ( I ) for completing SW ; and SBT + SW + PT + I. Both PT and I enhanced attendance at SWs , the combination producing the best adherence . Increased walk attendance did not result in higher overall energy expenditure , however , and long-term weight loss was also not improved . Post hoc analyses suggest that the level of exercise needed for successful long-term weight loss is much higher than that usually recommended in behavioral treatment programs",
"Background — The impact of overall dietary patterns that reflect actual eating behaviors on mortality caused by cardiovascular or other chronic diseases is largely unknown . Methods and Results — We prospect ively evaluated the relation between dietary patterns and risk of cardiovascular , cancer , and all-cause mortality among 72 113 women who were free of myocardial infa rct ion , angina , coronary artery surgery , stroke , diabetes mellitus , or cancer and were followed up from 1984 to 2002 . Dietary patterns were derived by factor analysis based on vali date d food frequency question naires administered every 2 to 4 years . Two major dietary patterns were identified : High prudent pattern scores represented high intakes of vegetables , fruit , legumes , fish , poultry , and whole grains , whereas high Western pattern scores reflected high intakes of red meat , processed meat , refined grains , french fries , and sweets/desserts . During 18 years of follow-up , 6011 deaths occurred , including 1154 cardiovascular deaths and 3139 cancer deaths . After multivariable adjustment , the prudent diet was associated with a 28 % lower risk of cardiovascular mortality ( 95 % confidence interval [ CI ] , 13 to 40 ) and a 17 % lower risk of all-cause mortality ( 95 % CI , 10 to 24 ) when the highest quintile was compared with the lowest quintile . In contrast , the Western pattern was associated with a higher risk of mortality from cardiovascular disease ( 22 % ; 95 % CI , 1 to 48 ) , cancer ( 16 % ; 95 % CI , 3 to 30 ) , and all causes ( 21 % ; 95 % CI , 12 to 32 ) . Conclusion — Greater adherence to the prudent pattern may reduce the risk of cardiovascular and total mortality , whereas greater adherence to the Western pattern may increase the risk among initially healthy women",
"ABSTRACT BACKGROUND Previous efforts to use incentives for weight loss have result ed in substantial weight regain after 16 weeks . OBJECTIVE To evaluate a longer term weight loss intervention using financial incentives . DESIGN A 32-week , three-arm r and omized controlled trial of financial incentives for weight loss consisting of a 24-week weight loss phase during which all participants were given a weight loss goal of 1 pound per week , followed by an 8-week maintenance phase . PARTICIPANTS Veterans who were patients at the Philadelphia Veterans Affairs Medical Center with BMI s of 30–40.INTERVENTION Participants were r and omly assigned to participate in either a weight-monitoring program involving a consultation with a dietician and monthly weigh-ins ( control condition ) , or the same program with one of two financial incentive plans . Both incentive arms used deposit contracts ( DC ) in which participants put their own money at risk ( matched 1:1 ) , which they lost if they failed to lose weight . In one incentive arm participants were told that the period after 24 weeks was for weight-loss maintenance ; in the other , no such distinction was made . MAIN MEASUREWeight loss after 32 weeks . KEY RESULTS Results were analyzed using intention-to-treat . There was no difference in weight loss between the incentive arms ( P = 0.80 ) . Incentive participants lost more weight than control participants [ mean DC = 8.70 pounds , mean control = 1.17 , P = 0.04 , 95 % CI of the difference in means ( 0.56 , 14.50 ) ] . Follow-up data 36 weeks after the 32-week intervention had ended indicated weight regain ; the net weight loss between the incentive and control groups was no longer significant ( mean DC = 1.2 pounds , 95 % CI , -2.58–5.00 ; mean control = 0.27 , 95 % CI , -3.77–4.30 , P = 0.76 ) . CONCLUSIONS Financial incentives produced significant weight loss over an 8-month intervention ; however , participants regained weight post-intervention",
"Behavioral treatments for obesity seek to modify eating and exercise behaviors by a change in their antecedents and consequences . More direct modification of antecedents and consequences by ( a ) the provision of food to patients and ( b ) the provision of financial rewards for weight loss was hypothesized to improve treatment outcomes . Two hundred two men and women were r and omly assigned to no treatment , st and ard behavioral treatment ( SBT ) , SBT plus food provision , SBT plus incentives , or SBT plus food provision and incentives . The major finding was that food provision significantly enhanced weight loss . Weight losses with SBT averaged 7.7 , 4.5 , and 4.1 kg at 6 , 12 , and 18 months , respectively , compared with 10.1 , 9.1 , and 6.4 kg , respectively , at the same intervals with the addition of food . Food provision also enhanced attendance , completion of food records , quality of diet , and nutrition knowledge . We conclude that the provision of food to weight-loss patients is a promising methodology that deserves further exploration",
"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",
"Reports of studies relating physical activity to stroke and cancer sub-types indicate inconsistent findings . Some are hampered by low statistical power , owing to a low number of events , and a failure to adjust for potential confounding variables . The purpose of this study was to relate physical activity to 12 mortality endpoints in a prospect i ve cohort study of 11,663 men aged 40–64 years who responded to an enquiry about travel activity during a baseline medical examination conducted between 1967 and 1969 . During 25 years of follow-up there were 4672 deaths . Travel activity was inversely related to mortality attributable to all-causes , coronary heart disease , respiratory disease and lung cancer , whereas the association with stroke was positive . There was evidence for attenuation of some of these associations on adjustment for potentially confounding variables . Our simplistic measure of physical activity may , in part , explain the weak associations seen",
"BACKGROUND Smoking is the leading preventable cause of premature death in the United States . Previous studies of financial incentives for smoking cessation in work setting s have not shown that such incentives have significant effects on cessation rates , but these studies have had limited power , and the incentives used may have been insufficient . METHODS We r and omly assigned 878 employees of a multinational company based in the United States to receive information about smoking-cessation programs ( 442 employees ) or to receive information about programs plus financial incentives ( 436 employees ) . The financial incentives were $ 100 for completion of a smoking-cessation program , $ 250 for cessation of smoking within 6 months after study enrollment , as confirmed by a biochemical test , and $ 400 for abstinence for an additional 6 months after the initial cessation , as confirmed by a biochemical test . Individual participants were stratified according to work site , heavy or nonheavy smoking , and income . The primary end point was smoking cessation 9 or 12 months after enrollment , depending on whether initial cessation was reported at 3 or 6 months . Secondary end points were smoking cessation within the first 6 months after enrollment and rates of participation in and completion of smoking-cessation programs . RESULTS The incentive group had significantly higher rates of smoking cessation than did the information-only group 9 or 12 months after enrollment ( 14.7 % vs. 5.0 % , P Incentive-group participants also had significantly higher rates of enrollment in a smoking-cessation program ( 15.4 % vs. 5.4 % , P completion of a smoking-cessation program ( 10.8 % vs. 2.5 % , P smoking cessation within the first 6 months after enrollment ( 20.9 % vs. 11.8 % , P financial incentives for smoking cessation significantly increased the rates of smoking cessation . ( Clinical Trials.gov number , NCT00128375 .",
"AIMS This study examined whether voucher-based reinforcement therapy ( VBRT ) contingent upon smoking abstinence during pregnancy is an effective method for decreasing maternal smoking during pregnancy and improving fetal growth . DESIGN , SETTING AND PARTICIPANTS A two-condition , parallel-groups , r and omized controlled trial was conducted in a university-based research clinic . A total of 82 smokers entering prenatal care participated in the trial . INTERVENTION Participants were assigned r and omly to either contingent or non-contingent voucher conditions . Vouchers exchangeable for retail items were available during pregnancy and for 12 weeks postpartum . In the contingent condition , vouchers were earned for biochemically verified smoking abstinence ; in the non-contingent condition , vouchers were earned independent of smoking status . MEASUREMENTS Smoking outcomes were evaluated using urine-toxicology testing and self-report . Fetal growth outcomes were evaluated using serial ultrasound examinations performed during the third trimester . FINDINGS Contingent vouchers significantly increased point-prevalence abstinence at the end-of-pregnancy ( 41 % versus 10 % ) and at the 12-week postpartum assessment ( 24 % versus 3 % ) . Serial ultrasound examinations indicated significantly greater growth in terms of estimated fetal weight , femur length and abdominal circumference in the contingent compared to the non-contingent conditions . CONCLUSIONS These results provide further evidence that VBRT has a substantive contribution to make to efforts to decrease maternal smoking during pregnancy and provide new evidence of positive effects on fetal health",
"Low response rates , especially among physicians , are a common problem in mailed survey research . We conducted a r and omized trial to examine the effects of cash and lottery incentives on response rates . A total of 4,850 subjects were r and omized to one of three interventions accompanying a mailed survey-no incentive ( n = 1,700 ) , cash payment [ three levels of Hong Kong dollars ( HKD ) $ 10 , $ 20 , and $ 40 ; N = 50 in each subgroup ] , or entry into a lottery ( three levels of HKD$1,000 , $ 2,000 , and $ 4,000 ; N = 1,000 in each subgroup ) on receipt of the completed question naire . The response rates were higher among those offered incentives than those without ( 19.8 % vs. 16.8 % , P = .012 ) . Cash was the more effective incentive compared to lottery ( 27.3 % vs. 19.4 % , P = .017 ) . Response also increased substantially between the first and second mailings ( 14.2 % vs. 18.8 % , P > .001 ) . In addition , those with specialist qualifications were more willing to participate in mailed surveys . We found no significant differences in response outcomes among the various incentive arms . Cash reward at the $ 20 level was the most cost-effective intervention , in terms of cost per responder . Further systematic examination of the effects of different incentive strategies in epidemiologic studies should be encouraged",
"BACKGROUND Physical activity is associated with low mortality in men , but little is known about the association in women , different age groups , and everyday activity . OBJECTIVE To evaluate the relationship between levels of physical activity during work , leisure time , cycling to work , and sports participation and all-cause mortality . DESIGN Prospect i ve study to assess different types of physical activity associated with risk of mortality during follow-up after the subsequent examination . Mean follow-up from examination was 14.5 years . SETTING Copenhagen University Hospital , Copenhagen , Denmark . PARTICIPANTS Participants were 13,375 women and 17,265 men , 20 to 93 years of age , who were r and omly selected . Physical activity was assessed by self-report , and health status , including blood pressure , total cholesterol level , triglyceride levels , body mass index , smoking , and educational level , was evaluated . MAIN OUTCOME MEASURE All-cause mortality . RESULTS A total of 2,881 women and 5,668 men died . Compared with the sedentary , age- and sex-adjusted mortality rates in leisure time physical activity groups 2 to 4 were 0.68 ( 95 % confidence interval , 0.64 - 0.71 ) , 0.61 ( 95 % confidence interval , 0.57 - 0.66 ) , and 0.53 ( 95 % confidence interval , 0.41 - 0.68 ) , respectively , with no difference between sexes and age groups . Within the moderately and highly active persons , sports participants experienced only half the mortality of non participants . Bicycling to work decreased risk of mortality in approximately 40 % after multivariate adjustment , including leisure time physical activity . CONCLUSIONS Leisure time physical activity was inversely associated with all-cause mortality in both men and women in all age groups . Benefit was found from moderate leisure time physical activity , with further benefit from sports activity and bicycling as transportation",
"AIMS To evaluate relapse prevention ( relapse prevention ) and contingency management ( contingency management ) for optimizing smoking cessation outcomes using nicotine replacement therapy for methadone-maintained tobacco smokers . DESIGN Experimental , 2 ( relapse prevention)x2 ( contingency management ) repeated measures design using a platform of nicotine replacement therapy featuring a 2-week baseline period , followed by r and omization to 12 weeks of treatment , and 6- and 12-month follow-up visits . SETTING Three narcotic treatment centers in Los Angeles . PARTICIPANTS One hundred and seventy-five participants who met all inclusion and no exclusion criteria . INTERVENTION Participants received 12 weeks of nicotine replacement therapy and assignment to one of four conditions : patch-only , relapse prevention + patch , contingency management + patch and relapse prevention + contingency management + patch . MEASUREMENTS Thrice weekly sample s of breath ( analyzed for carbon monoxide ) and urine ( analyzed for metabolites of opiates and cocaine ) and weekly self-reported numbers of cigarettes smoked . FINDINGS Participants ( 73.1 % ) completed 12 weeks of treatment . During treatment , those assigned to receive contingency management showed statistically higher rates of smoking abstinence than those not assigned to receive contingencies ( F3,4680=6.3 , P=0.0003 ) , with no similar effect observed for relapse prevention . At follow-up evaluations , there were no significant differences between conditions . Participants provided more opiate and cocaine-free urines during weeks when they met criteria for smoking abstinence than during weeks when they did not meet these criteria ( F1,2054=14.38 , P=0.0002 ; F1,2419=16.52 , P Contingency management optimized outcomes using nicotine replacement therapy for reducing cigarette smoking during treatment for opiate dependence , although long-term effects are not generally maintained . Findings document strong associations between reductions in cigarette smoking and reductions in illicit substance use during treatment",
"In this cluster r and omised trial ( N=1060 ) , we tested the impact of financial incentives ( £ 5 voucher vs. £ 200 lottery ) framed as a gain or loss to promote Chlamydia screening in students aged 18 - 24 years , mimicking the st and ard outreach approach to student in halls of residence . Compared to the control group ( 1.5 % ) , the lottery increased screening to 2.8 % and the voucher increased screening to 22.8 % . Incentives framed as gains were marginally more effective ( 10.5 % ) that loss-framed incentives ( 7.1 % ) . This work fundamentally contributes to the literature by testing the predictive validity of Prospect Theory to change health behaviour in the field",
"Smoking causes chronic obstructive pulmonary disease ( COPD ) , but few controlled studies have tested anti-smoking treatments in COPD . With procedures likely to attract unmotivated persons we recruited 49 quite-ill , smoking COPD patients . During one or two daily home visits for 85 days , breath carbon monoxide ( CO ) and self-reports of daily smoking were obtained . Patients , given quit date s and nicotine gum ( 2-mg pieces , up to 30 per day ) , were assigned r and omly to three groups : Experimentals were reinforced with lottery tickets for CO were reinforced for reporting no smoking that day . Controls received non-contingent payments . Each group 's mean CO level fell at the quit date . Thereafter , reinforced patients maintained significantly lower CO levels than Controls . Although many more 24-h abstentions occurred in the intervention period than in baseline , few patients sustained abstinence ; the groups did not differ in that regard . Outcome was predicted by decisions to throw away cigarettes when intervention began , but not by motivation scales nor Fagerstrom dependence scores . Pay schedules apparently exaggerated self-reports of reduced smoking . Although results are statistically significant , there is still no proven , practical treatment for smoking in advanced COPD",
"Exercise is important for long-term weight loss , but few studies have examined ways to improve exercise adherence in overweight subjects participating in a behavioral weight loss program . This paper presents two studies , one conducted at the University of Pittsburgh and one at the University of Minnesota , that sought to improve exercise adherence by exerting more direct control over the environmental antecedents and consequences controlling exercise . Study 1 investigated the use of a personal trainer who called participants regularly and met them at their home or office at scheduled times for a walk . Study 2 investigated the effect of a lottery incentive for exercise adherence . In both studies , the effect of these manipulations was examined in the context of a 24-week st and ard behavioral weight control program with three supervised exercise sessions per week . Neither intervention achieved statistically significant improvements in exercise adherence compared to control conditions , perhaps due in part to the limited statistical power of the studies . Future studies should focus on better underst and ing the barriers to exercise and design ing behavioral interventions that address these barriers",
"This study examined the relative contribution of contingent payment and worksite CO monitoring to the long-term maintenance of smoking abstinence . Forty-seven hospital employees who had abstained from smoking for five days ( confirmed by CO analysis ) were r and omly assigned to one of three follow-up groups : ( a ) contingent payment/frequent monitoring ( n = 17 ) ; ( b ) noncontingent payment/frequent monitoring ( n = 16 ) ; or ( c ) non-contingent payment/infrequent monitoring ( n = 14 ) . Contingent payment combined with frequent CO monitoring delayed but did not ultimately prevent subjects relapse to smoking by the end of the six month follow-up . Contingent subjects maintained CO values less than or equal to 11 ppm significantly longer than did either the Non-contingent or the Control subjects ( p = .03 ) . CO monitoring alone had no effect on abstinence outcomes ; both Noncontingent and Control subjects showed high rates of early relapse",
"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",
"A 2 × 2 r and omized , factorial pretest/posttest group design was used to evaluate the effectiveness of self-help smoking cessation methods at the worksite . The study investigated the effect of a multicomponent health education and skill intervention versus the effect of a monetary incentive to the employee for quitting . All employees received , in addition , a st and ardized self-help smoking cessation manual and maintenance manual . Following agreement to participate and a baseline smoking history , all participants were followed for 6 weeks , 6 months , and 12 months . Saliva was obtained for thiocyanate ( SCN ) analysis of smoking status . Of the estimated 2000 smokers at the site , 387 smokers were recruited . Employees were r and omly assigned to one of four groups . Results of this r and om trial indicate that those employees receiving a multicomponent program were most successful in quitting and remaining abstinent . The monetary incentive appears to have no effect on quit rate",
"We report results from a pilot study examining the use of vouchers redeemable for retail items as incentives for smoking cessation during pregnancy and postpartum . Of 100 study -eligible women who were still smoking upon entering prenatal care , 58 were recruited from university-based and community obstetric practice s to participate in a smoking cessation study . Participants were assigned to either contingent or noncontingent voucher conditions . Vouchers were available during pregnancy and for 12 weeks postpartum . In the contingent condition , vouchers were earned for biochemically verified smoking abstinence . In the noncontingent condition , vouchers were earned independent of smoking status . Abstinence monitoring and associated voucher delivery was conducted daily during the initial 5 days of the cessation effort , gradually decreased to every other week antepartum , increased to once weekly during the initial 4 weeks postpartum , and then decreased again to every other week for the remaining 8 weeks of the postpartum intervention period . Contingent vouchers increased 7-day point-prevalence abstinence at the end-of-pregnancy ( 37 % vs. 9 % ) and 12-week postpartum ( 33 % vs. 0 % ) assessment s. That effect was sustained through the 24-week postpartum assessment ( 27 % vs. 0 % ) , which was 12 weeks after discontinuation of the voucher program . Total mean voucher earnings across antepartum and postpartum were 397 US dollars ( SD=414 US dollars ) and 313 US dollars ( SD=142 dollars ) in the contingent and noncontingent conditions , respectively . The magnitude of these treatment effects exceed levels typically observed with pregnant and recently postpartum smokers , and the maintenance of effects through 24 weeks postpartum extends the duration beyond those reported previously",
"This study evaluated the impact of a year-long incentives-based worksite smoking-cessation program . Nineteen moderate-sized worksites , employing a total of approximately 1100 smokers , were r and omized to Incentive or No Incentive conditions . All identified smokers in the worksite were considered as subjects , whether or not they participated in the intervention . Analyses were conducted at both the worksite and individual level , and using both self-reported and biochemically vali date d cessation as endpoints . The incentive program did not significantly improve cessation rates at either the 1-year or 2-year follow-up assessment s. We conclude that more broadly focused interventions that also address worksite smoking policies , skills training , and cessation re sources , or programs that target additional risk factors are needed to substantially enhance quit rates",
"Abstract Adults with any DSM-IV diagnosed mental illness smoke nearly half of the cigarettes consumed in the U.S. ( Lasser et al. 2000 ) . This study compared two smoking cessation interventions for persons with schizophrenia or other serious mental illness because national data suggests that : ( 1 ) they smoke at two to three times the rate of the general population ; ( 2 ) cessation interventions for this population are understudied ; ( 3 ) most cessation studies exclude persons with serious mental illness ; and ( 4 ) cessation results in public health care savings and disposable income savings for clients . This study included a large number of persons with serious mental illness ( N = 181 ) who were r and omly assigned to one of three groups : contingent reinforcement ( CR ) , CR plus nicotine patch ( 21 mg , CR+NRT ) for 16 weeks , and a minimal intervention , self-quit control group . These participants were followed for 36 weeks . CR was accomplished with escalating financial compensation for achieving and maintaining abstinence as verified by expired carbon monoxide ( CO ) . Quit rates , as measured by expired CO , were higher and discordant with saliva cotinine quit rates . Cotinine showed lower quit rates and small differences between intervention and control partici pants at weeks 20 and 36 . There was , however , evidence of reduced smoking and importantly , no evidence of psychiatric exacerbation",
"Smoking cessation interventions have posed significant challenges for health professionals , particularly when directed at high risk , low income , pregnant smokers . Typical quit rates for pregnant women who receive publicly financed obstetrical care have rarely exceeded 12–16%.1 As many as 70 % of women who quit smoking during pregnancy relapse within one year of delivery.2 Two areas that have received particular attention as possible adjuncts to behaviour change are the use of reinforcements and social supports . Reinforcement in the form of incentives/rewards for positive behaviours has been controversial as an intervention strategy . Some argue that the “ overjustification effect ” of external rewards may cause subjects to lose internal motivation to modify behaviour over the long term.3 However , results of several studies , including two meta-analyses on reinforcement , provide compelling evidence that positive reinforcement provides positive behavioural changes.4 - 8 A second area of study that has been explored in the behaviour change research is the role of social support in motivating and sustaining selected behaviour change . Recent studies have empirically linked tobacco quit rates with daily interaction with a supportive “ other , ” preferably one who did not smoke.9 10 The primary objective of our intervention was to determine whether the combination of bolstered social support and financial incentives had an effect in significantly reducing smoking behaviour among low income , high risk , pregnant and postpartum women who participate in Oregon 's Women , Infants , and Children ( WIC ) program . The Significant Other Supporter ( SOS ) program was a r and omised , experimentally design ed smoking cessation study implemented in four Oregon WIC program sites . Criteria for entry into the study included the following : age 15 years or older ; self reported smoker ( “ even a puff in the last seven days ” ) ; English speaker/reader ; WIC eligible ; and 28 weeks gestation or less . Eligible subjects were r and omised into one of two groups , and were",
"OBJECTIVES This study examined the effect of program format and incentives on participation and cessation in worksite smoking cessation programs . METHODS Twenty-four worksites were r and omized to 6 conditions that differed in cessation program format and the use of incentives . Programs were offered for 18 months in each worksite . A total of 2402 cigarette smokers identified at baseline were surveyed 12 and 24 months later to assess participation in programs and cessation . RESULTS A total of 407 ( 16.9 % ) of the smoker cohort registered for programs ; on the 12- and 24-month surveys , 15.4 % and 19.4 % of the cohort , respectively , reported that they had not smoked in the previous 7 days . Registration for programs in incentive sites was almost double that of no-incentive sites ( 22.4 % vs 11.9 % ) , but increased registration did not translate into significantly greater cessation rates . Program type did not affect registration or cessation rates . CONCLUSIONS Although incentives increase rates of registration in worksite smoking cessation programs , they do not appear to increase cessation rates . Phone counseling seems to be at least as effective as group programs for promoting smoking cessation in worksites",
"OBJECTIVES This study reports an efficacy trial of four work-site health promotion programs . It was predicted that strategies making use of behavioral counseling would produce a greater reduction in cardiovascular disease risk factors than screening and educational strategies . METHODS Twenty-eight work sites were r and omly allocated to a health risk assessment , risk factor education , behavioral counseling , or behavioral counseling plus incentives intervention . Participants were assessed before the intervention and at 3 , 6 , and 12 months . RESULTS Compared with the average of the health risk assessment and risk factor education conditions , there were significantly higher vali date d continuous smoking cessation rates and smaller increases in body mass index and estimated percentage of body fat in the two behavioral counseling conditions . The behavioral counseling condition was associated with a greater reduction in mean blood pressure than was the behavioral counseling plus incentives condition . On average among all groups , there was a short-term increase in aerobic capacity followed by a return to baseline levels . CONCLUSIONS Work-site interventions that use behavioral approaches can produce lasting changes in some cardiovascular risk factors and , if implemented routinely , can have a significant public health impact",
"OBJECTIVE To evaluate the impact of a health fair and incentive program on the reduction of serum cholesterol levels among participants . DESIGN Pretest-posttest control group design , with a 6-month delay between pretest and posttest screenings . SETTING Health fair program for employees of a large midwestern school district . PARTICIPANTS Volunteer sample among persons with serum cholesterol levels above 5.17 mmol/L ( 200 mg/dL ) . Participants were r and omly assigned to experimental ( N = 29 ) and comparison groups ( N = 34 ) . INTERVENTION The intervention consisted of four components : a health fair , health risk information , announcement of follow-up screening , and an incentive program . The incentive program consisted of five $ 100 cash prizes for reducing serum cholesterol levels by 20 % or below 5.17 mmol/L ( 200 mg/dL ) . The comparison group received only the first three components . MAIN OUTCOME MEASURE Serum cholesterol levels were measured by a venipuncture , nonfasting , chemical analysis process . RESULTS The experimental group showed a 13.2 % reduction in serum cholesterol levels , and the comparison group exhibited an 11.3 % reduction ( P health fair , consisting of information on the level of risk and how to reduce risk , and announcement of follow-up screening and incentives can reduce the risk for cardiovascular disease",
"Mailed invitations to participate in weight loss and /or smoking cessation correspondence programs to 31,400 households in a suburban community . Two programs were offered to r and omized subsets of households , a 6-month correspondence program costing + 5 and the same program for free but requiring a + 60 deposit to be refunded based on success in weight loss or smoking cessation . Overall , sign-up included 1,304 people for weight loss and 142 for smoking cessation . The + 5 program was about 5 times as popular as the incentive program . Vali date d weight change after 6 months averaged about 4 lb for the + 5 program and 8 lb for the incentive program . Corresponding rates of smoking cessation were about 9 % and 20 % , respectively . We conclude that correspondence programs for the promotion of weight control and smoking cessation are potentially cost-effective methods for reaching individuals in the community at large , many of whom would not be interested in clinic-based programs . Issues meriting further research include recruitment , especially of smokers , and evaluation of the relative trade-offs in recruitment success versus efficacy of differing treatment approaches"
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41174e66-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES Despite nanofill and su bmi cron composites ' aim to provide high initial polishing combined with superior smoothness and gloss retention , the question still remains whether clinicians should consider using these new material s over traditional microhybrids . The aim of this paper was to systematic ally review the literature on how nanofills and su bmi crons react to polishing procedures and surface challenges in vitro compared with microhybrids . The paper has also given an overview of the compositional characteristics of all resin composites and polishing systems whose performance was presented herein . DATA The data base search for the effect of filler size on surface smoothness and gloss of commercial composites retrieved 702 eligible studies . After deduplication , 438 records were examined by the titles and abstract s ; 400 studies were excluded and 38 articles were assessed for full-text reading . An additional 11 papers were selected by h and - search ing . In total , 28 articles met inclusion criteria and were included in the study . SOURCES The data bases analyzed were MEDLINE / PubMed , ISI Web of Science , and SciVerse Scopus . STUDY SELECTION Papers were selected if they presented a comparison between nanofill or su bmi cron and microhybrid composites with quantitative analysis of smoothness and /or gloss on baseline and /or after any aging protocol to assess smoothness and gloss retention . Only in vitro studies written in English were included . CONCLUSIONS There is no in vitro evidence to support the choice for nanofill or su bmi cron composites over traditional microhybrids based on better surface smoothness and /or gloss , or based upon maintenance of those superficial characteristics after surface challenges
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"OBJECTIVE The purpose of this study was to evaluate surface finish and gloss of a two-step composite finishing/polishing ( F/P ) disc system compared with two multistep systems on five composites . METHODS Seventy-five disc-shaped composite specimens ( D=10.0 mm , 2 mm thick , n=15 per composite ) were made of microfill ( Durafill-D ) , nanofill ( Filtek Supreme-FS ) , nanohybrid ( Premise-PR ) , and microhybrids ( Filtek Z250-FZ , Esthet-EX ) . One side of each specimen was initially finished with a carbide bur . Five specimens of each resin composite were r and omly assigned to receive full F/P by each of the disc systems : two-step ( Enhance Flex NST-EF ) and four-step ( Sof-Lex-SL , Super-Snap-SS ) . Surface gloss was measured with a glossmeter and surface roughness was measured with a profilometer . Results were analyzed by two-way analysis of variance (ANOVA)/Tukey 's ( α No difference in gloss was noted among the three F/P systems when used with D and EX ; no difference between SL and EF when used with any composite , except for FS ; and no difference between SL and SS when used with any composite . SL and EF showed similar surface roughness when used on all composites , except for EX . EF and SS showed similar surface roughness on PR . SL and SS showed similar surface roughness values on every composite , except for FZ . CONCLUSIONS EF was capable of providing similar gloss and surface roughness to SL on four composites evaluated but was not able to produce as glossy or as smooth a surface as SS for three of the five composites",
"OBJECTIVES The aim of this in vitro study was to evaluate the effects of different finishing and polishing techniques on the surface roughness and color stability of nanocomposites . METHODS Two nanohybrid ( Gr and io , Aelite Aesthetic Enamel ) , two nanofill ( Filtek Supreme XT Dentin and Translucent ) , and a microhybrid ( Filtek Z250 ) composites were used . Two hundred and eighty disc-shaped specimens were cured under a mylar strip . Seven specimens of each resin composite were r and omly assigned to one of the seven polishing systems . A profilometer was used for assessing surface roughness . ΔE was calculated with a colorimeter at baseline and 48 h after storage in a coffee solution . The results were analysed by two-way ANOVA and Tukey 's HSD test ( α=0.05 ) . Regression analysis was used to examine the correlation between surface roughness and color stability ( α=0.01 ) . RESULTS There was no significant difference in R(a ) values between mylar strips and Sof-Lex polishing discs ( p>0.05 ) . The highest ΔE and R(a ) values were obtained from Gr and io ( p ΔE values ( p lowest color differences among all the finishing systems . The highest ΔE values were found in the composite resin groups under mylar strips and finished with diamond burs ( p lowest surface roughness , the Enhance Polishing system provided the most stain-resistant groups . Gr and io presented the highest surface roughness and staining susceptibility after storage in coffee solution . Aelite Aesthetic Enamel , which did not include TEGDMA in its composition , showed the least discoloration . CLINICAL SIGNIFICANCE The composites with smaller filler size did not necessarily show low surface roughness and discoloration . Staining of composite resins was dependent on monomer structure , as well as surface irregularities",
"Objectives : The aim of this study was to investigate the superficial texture of composite restorations after different bleaching protocol s. Methods : Filtek Supreme ( S ) , Filtek Z350 ( F ) , and Gr and io ( G ) were compared to Opallis ( O ) and Filtek Z250 ( Z ) ( control microhybrid composites ) and to bovine enamel using three different bleaching agents : 35 % hydrogen peroxide Whiteness HP ( WHP ) , 35 % Whiteness HP MAXX ( WMAXX ) and 16 % carbamide peroxide Whiteness St and ard ( WS ) . Six specimens from each composite were treated using each bleaching agent , according to the manufacturers ’ instructions . Three r and om sites were measured for superficial roughness ( Hommel Tester T 1000 ) weekly for each sample . Data were analyzed for each bleaching system using two-way ANOVA and Bonferroni tests at 5 % significance level . Results : WHP treatment significantly altered the Filtek Supreme composite over time . When WMAXX was used , Gr and io displayed the most significant alterations in surface roughness throughout the evaluation period , which was not observed for the other nanocomposites . Using WS , Filtek Z250 presented significant surface alterations over time , which was not seen in the nanofilled material s. Conclusions : Surface roughness alteration was material and time-dependent . The bleaching gels affected nanofilled and microhybrid composite resins . Enamel was the surface less affected by bleaching",
"This study evaluated the effects of acidic medicines ( Dimetapp ® and Claritin ® ) , under pH-cycling conditions , on the surface degradation of four composite resins ( microhybrid : TPH , Concept , Opallis and Nanofilled : Supreme ) . Thirty disc-shaped specimens ( Ø = 5.0 mm / thickness = 2.0 mm ) of each composite were r and omly assigned to 3 groups ( n = 10 ) : a control and two experimental groups , according to the acidic medicines evaluated . The specimens were finished and polished with aluminum oxide discs , and the surface roughness was measured by using a profilometer . After the specimens were su bmi tted to a pH-cycling regimen and immersion in acidic medicines for 12 days , the surface roughness was measured again . Two specimens for each material and group were analyzed by scanning electron microscopy ( SEM ) before and after pH-cycling . Data were analyzed by the Student's-t test , ANOVA , Duncan 's multiple range test and paired t-test ( α=0.05 ) . Significant increase in roughness was found only for TPH in the control group and TPH and Supreme immersed in Claritin ® ( p underwent erosion and surface degradation after being subjected to the experimental conditions . In conclusion , although the roughness was slightly affected , the pH-cycling and acidic medicines caused surface degradation of the composite resins evaluated . Titratable acidity seemed to play a more crucial role on surface degradation of composite resins than",
"AIMS The aims of this study were to evaluate the effect of various finishing and polishing procedures on the surface roughness of six different composite resin material s ( Artemis Enamel , TPH Spectrum , Filtek A-110 , Filtek Supreme Enamel , Solitaire 2 , and Filtek P-60 ) as well as to evaluate the effectiveness of the surface sealant application ( BisCover ) on the surface roughness after finishing and polishing procedures of tested composites . METHODS AND MATERIAL S Specimens ( n=168 ) measuring 5 mm in diameter x 2 mm in thickness were fabricated in a plexiglass well covered with a Mylar strip using six composite resins . A control group of seven specimens of each material received no polishing after being cured under the Mylar strip . Twenty-one specimens for each composite were r and omly divided among three finishing and polishing groups ( n=7 ) . Each group was polished using a different system : Carbide bur/Sof-Lex disc , Carbide bur/Enhance disc with polishing paste , and Carbide bur/Edenta composite finishing kit . The average surface roughness ( Ra , microm ) of the control and treated specimens were measured with the Mitutoyo Surftest-402 Surface Roughness tester . After a surface sealant ( BisCover ) was applied to all treated specimens , according to manufacturer 's instructions , the average roughness ( Ra ) was measured again . Results were statistically analyzed using analysis of variance ( ANOVA ) and the post-hoc Scheffe 's test at a p surface roughness ( p0.05 ) . The Mylar strip group was not significantly different from the Sof-Lex/BisCover and Edenta/BisCover groups . The ranking of mean Ra values by material s was as follows : Filtek Supreme Enamel mean Ra values by polishing systems was as follows : Enhance/BisCover Mylar Strip surfaces were recorded for the Enhance/BisCover and the Mylar strip-formed surface groups . The composite finishing kit Edenta significantly increased the Ra for all tested composites ( p ( BisCover ) significantly improved the surface smoothness of all tested composites ( p BisCover surface sealant on anterior and posterior resin composite restorations after finishing and polishing procedures is recommended",
"OBJECTIVES Application of acidulated phosphate fluoride ( APF ) gels has long been considered to cause deterioration of composite surfaces . The aims of this study were to demonstrate that nanocomposite surfaces were not affected by some APF gels and to investigate the possible underlying mechanisms . METHODS The elemental composition and viscosity of 3 acidulated phosphate fluoride ( APF ) agents ( 60 Second Taste Gel , Topex , and Zap ) and 1 neutral fluoride agent ( pH7 Gel ) were analyzed . Subsequently , 320 specimens of 3 nanocomposites ( Premisa , Filtek Z350 , and Gr and io ) and a microhybrid composite ( Estelite Sigma ) with 80 specimens for each composite were r and omly divided into 5 groups ( n=16 ) and treated with 4 fluoride gels as well as distilled water which served as the control . Fluoride gels were applied on composite resin surfaces 4 times , 30 min each time . The roughness and microhardness were measured after treatments . Qualitative examination of the surface degradation of the composites was carried out with Fourier transforming infrared spectroscopy ( FTIR ) and scanning electron microscopy ( SEM ) . RESULTS Topex and Zap did not cause surface changes of composite resins , the possible reason being ascribed to the presence of magnesium aluminum silicate ( MAS ) clays . In contrast , 60 Second Taste Gel treatments caused significant roughness increase , microhardness decrease , more prominent filler dissolution , and IR spectral changes of Premisa , Filtek Z350 , and Gr and io . Estelite Sigma was less affected by the 4 fluoride gels . SIGNIFICANCE The composite surfaces were not affected by Topex or Zap even after extended treatments . These two APF gels may be more suitable for clinical applications",
"PURPOSE The purpose of this in vitro study was to evaluate the surface finish and gloss of five direct resin composites polished with six polishing systems . MATERIAL S AND METHODS One hundred and fifty disk-shaped composite specimens ( D=10.0 mm , 2-mm-thick , N=30 per material ) were made . One side of each specimen was finished with a 16-fluted carbide finishing bur and then polished . Five specimens of each resin composite were r and omly assigned to one of the six polishing systems . The surface roughness and gloss were measured with a surface profilometer and a glossmeter . The results were analyzed by two-way analysis of variance and Tukey 's t-test ( p surface roughness ( p=0.059 ) . The order of surface roughness ranked according to composite was : Durafill Esthet-X Supreme ; and the ranking for the polishing system was : Pogo gloss values between the composites and the polishing systems ( p highest gloss value was recorded for Supreme + Pogo ; the lowest was recorded for Z100 + Jiffy . Pogo showed the highest gloss values for all composites . CLINICAL SIGNIFICANCE The nanofill ( Supreme ) and minifill ( Esthet-X ) composites presented a surface roughness comparable to a microfill ( Durafill ) , independent of the polishing system used , and a gloss comparable to a microfill , when polished with a one-step system ( Pogo ) . As compared with the multiple-step systems , the smoothest surfaces and the highest gloss values were achieved using the one-step system ( Pogo ) for all the evaluated composites",
"OBJECTIVES This in vitro study evaluated the surface roughness and microhardness of nanocomposites that contain nanoparticles and a microhybrid composite finished and polished with two different one-step polishing systems and a conventional multi-step polishing system . METHODS AND MATERIAL S The material s evaluated were Filtek Supreme XT , Gr and io , Ceram X , Aelite Aesthetic Enamel , Tetric EvoCeram and Filtek Z250 . A total of 240 specimens ( 10-mm in diameter , 2 mm thick ) were fabricated for both tests ( n=120 each test ) in a plexiglass mold covered with a Mylar strip . After polymerization , five specimens per group received no polishing treatment and served as the control for both tests . For each composite group ( n=15 ) , the specimens were r and omly divided into three polishing systems : PoGo , OptraPol and Sof-Lex . All polishing systems were applied according to the manufacturers ' instructions after being ground wet with 1200 grid silicon carbide paper . The surface roughness values were determined using a profilometer . The microhardness measurements were performed using a digital microhardness tester ( load 500 g ; dwell time 15 seconds ) . The data were analyzed using the one-way ANOVA test at a significance level of 0.05 for both tests . Multiple comparison was performed with the Duncan Multiple Range test . RESULTS The smoothest surfaces were achieved under Mylar strips in all composite groups ( p surface roughness ( p>0.05 ) . In the Tetric EvoCeram group , Sof-Lex exhibited the highest roughness values . No statistically significant differences were evaluated between polishing systems ( p>0.05 ) ; whereas , the surfaces under Mylar Strip showed statistically significant lower values than the polished surfaces in terms of microhardness ( p<0.05 ) . CONCLUSION One-step polishing systems may be successfully used for polishing nanocomposites",
"AIM This study evaluated differences in surface roughness of a microhybrid ( Gradia Direct , GC America ) and a nanofil ( Filtek Supreme , 3 M ESPE ) composite using four polishing systems : PoGo/Enhance ( DENTSPLY/Caulk ) , Sof-Lex ( 3 M ESPE ) , Astropol ( Ivoclar Vivadent ) , and Optidisc ( KerrHawe ) . METHODS AND MATERIAL S An aluminum mold was used to prepare 2 X 60 composite disks ( 10 mm X 2 mm ) . Composite was packed into the mold , placed between two glass slabs , and polymerized for 40 seconds from the top and bottom surfaces . Specimens were finished to a st and ard rough surface using Moore 's disks with six brushing strokes . Specimens were rinsed and stored in artificial saliva in individual plastic bags at 36 degrees C for 24 hours prior to testing . Specimens were r and omly assigned to one of the four polishing systems and were polished for 30 seconds ( 10 seconds per grit ) with brushing strokes according to the manufacturer 's instructions . Mean surface roughness ( Ra ) was recorded with a surface-analyzer 24 hours after storage in artificial saliva , both before and after polishing . Means were analyzed using two-way and one-way analysis of variance ( ANOVA ) and Tukey multiple comparison tests at p smoother surface ( Ra=0.80 + /- 0.21 ) than Optidisc ( Ra=0.93 + /- 0.28 ) , Astropol ( Ra=1.15 + /- 0.24 ) , and Pogo/Enhance ( Ra=1.39 + /- 0.39 ) . For Gradia , Sof-Lex provided a significantly smoother surface ( Ra=0.47 + /- 0.09 ) and Astropol provided a significantly rougher surface ( Ra=1.39 + /- 0.19 ) than Pogo/Enhance ( Ra=1.11 + /- 0.20 ) and Optidisc ( Ra=1.15 + /- 0.18 ) . There was no significant difference in roughness between composites for individual polishing systems ( p=0.3991 ) . CONCLUSION Filtek specimens were smoother than Gradia specimens after baseline roughening . Sof-Lex provided the smoothest final surface when used with either composite . Astropol provided a rough surface for Gradia specimens",
"The purpose of this study was to evaluate the effect of several finishing and polishing procedures on the surface roughness of nanofill and nanohybrid composites and ormocer-based dental restorative material s. The material s included a nanofill composite ( Supreme ) ; a nanohybrid composite ( Gr and io ) ; and an ormocer ( organically modified ceramic ) ( Admira ) . Forty specimens of each material were prepared using a Mylar strip ( polyester strip ) and r and omly divided into four finishing and polishing groups ( n 1/4 10 ) : ( I ) Diamondbur/Super-snapRainbowTechniqueKit(Al2O2-coated , grade d abrasive discs ) ; ( II ) Diamond bur/Astropol and Astrobrush system ( silicone abrasive polishers and brush system ) ; ( III ) Tungsten carbide bur/Super-snap Rainbow Technique Kit ; and ( IV ) Tungsten carbide bur/Astropol and Astro-brush system . The average surface roughness ( Ra ) in micrometers was measured using a “ Mahr Perthometer S4P ” Surface Roughness Tester and the data were compared using ANOVA at P 0.05 . The results of this study indicated that the Mylar strip produced the smoothest surface on all material s and among the finishing-polishing methods the first and the third methods performed significantly smoother surfaces than the second and the fourth methods for the three restoratives . Ormocer ( Admira ) performed the lowest variability in initial surface roughness among the tested material s . This study has shown that Super-snap abrasive discs produced a smoother surface than the Astropol and Astrobrush silicone polishers for composite and ormocer-based restorative material s , but the results would be valid clinical ly for readily accessible and flat surfaces i.e. , not for all areas in the mouth . Therefore silicone polishers are necessary for posterior areas and for concave and convex surfaces",
"BACKGROUND Surface quality of dental restorations is one of the important factors that determine the success of the restoration . Unfortunately , exterior discoloration is still a problem for dental resin composites . PURPOSE The purpose of the study was to investigate the influential factors on stain resistance of dental resin composites . MATERIAL S AND METHODS Filtek Supreme ( nanocomposite ) , Filtek A110 ( microfilled composite ) , Filtek Z250 ( microhybrid composite ) , and Filtek P60 ( microhybrid composite ) ( all products from 3 M ESPE , St. Paul , MN , USA ) were tested . Thirty-six specimens per material were prepared and r and omly assigned to 6 groups . The specimens in 5 groups were polished against 1,000- , 1,200- , 1,500- , 2,000- , and 2,500-grit s and paper , respectively . The specimens in a sixth group were polished with 2,500-grit or 1,200-grit s and paper and used as controls . Surface roughness ( Ra ) and gloss of the specimens were measured with a profilometer and a glossmeter , respectively . Specimens were immersed in a coffee solution ( control group in distilled water ) and kept in a 37 degrees C incubator . Color was measured by a spectrophotometer at baseline , 3 days , 7 days , and 14 days , and color change ( DeltaE*(ab ) ) was calculated . RESULTS Coffee , material , Ra , and the interaction of material x Ra had statistically significant influences on the stain resistance of the dental composites tested . For most material s in coffee solution , time squared and Ra had significant effects on the discoloration . CONCLUSIONS Coffee had a significant influence on discoloration of the dental resin composite material s tested . The different composites behaved differently in coffee solution . Discoloration increased as Ra increased for the composites tested , except with Filtek A110 . The discoloration process was accelerated with time"
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In order to determine the impact of garlic on total cholesterol ( TC ) , TAG levels , as well as LDL and HDL , and establish if any variables have an impact on the magnitude of this effect , a meta- analysis was conducted . A systematic literature search of MEDLINE , CINAHL and the Cochrane Data base from the earliest possible date through to November 2007 was conducted to identify r and omised , placebo-controlled trials of garlic that reported effects on TC , TAG concentrations , LDL or HDL . The weighted mean difference of the change from baseline ( with 95 % CI ) was calculated as the difference between the means in the garlic groups and the control groups using a r and om-effects model . Subgroup and sensitivity analyses were performed to determine the effects on type , br and and duration of garlic therapy as well as baseline TC and TAG levels , the use of dietary modification , and study quality on the meta- analysis 's conclusions . Twenty-nine trials were included in the analysis . Upon meta- analysis garlic was found to significantly reduce TC ( - 0.19 ; 95 % CI - 0.33 , - 0.06 mmol/l ) and TAG ( - 0.11 ; 95 % CI - 0.19 , - 0.06 mmol/l ) but exhibited no significant effect on LDL or HDL . There was a moderate degree of statistical heterogeneity for the TC and TAG analyses . Garlic reduces TC to a modest extent , an effect driven mostly by the modest reductions in TAG , without appreciable LDL lowering or HDL elevation . Higher baseline line TC levels and the use of dietary modification may alter the effect of garlic on these parameters . Future studies should be conducted evaluating the impact of adjunctive garlic therapy with fibrates or statins on TAG concentrations
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"The hypolipidemic effect of Kwai , a preparation based on garlic powder ( Allium sativum ) , depended on the initial content of cholesterol and /or triglycerides . This effect was most pronounced in patients with coronary heart disease with initial cholesterol > 7.0 mmol/liter and triglyceride > 1.92 mmol/liter . After treatment with Kwai the correlation between triglyceride content and leukocyte count remained unchanged , the correlation between cholesterol content and leukocyte count disappeared , fibrinogen concentration decreased by 11 % , and no correlation was found between fibrinogen content and leukocyte count",
"BACKGROUND Garlic ( Allium Sativum ) has been used in herbal medicine for centuries for various ailments . In recent years garlic has been the focus of serious medical and clinical attention because of beneficial effects on several cardiovascular risk factors like reduction of serum lipids , blood pressure and plasma viscosity . There is also wide spread belief among general public that garlic has beneficial effects on cardiovascular system . The purpose of present study was to evaluate the effects of garlic on one of the major cardiovascular risk factors i.e. dyslipidemia in patients with type 2 diabetes mellitus . METHOD This 12 week r and omized , single-blind , placebo controlled study was conducted on Type 2 diabetic patients with newly diagnosed dyslipidemia ( n=70 ) . Patients were selected from Diabetic OPD of Jinnah Post Graduate Medical Centre , Karachi and were divided into two groups each comprising of 35 patients , they were given tablet garlic ( Garlex-Bosch Pharmaceuticals ) 300 mg ( containing 1.3 % allicin ) twice daily and identical placebo tablets respectively . Both groups were given diet and exercise plan . RESULTS After 12 weeks the garlic treated group ( n = 33 ) had a significant reduction in total cholesterol ( -28 mg/dl , - 12.03 % P= LDL - C ( -30 mg/dl , - 17.99 % P= placebo treated group ( n=32 ) had a non significant decrease in total cholesterol ( - 2 mg/dl , - 0.9 % p= ns ) and LDL-C ( -3 mg/dl , -1.6 % p = ns ) . HDL cholesterol was significantly increased in patients treated with garlic ( 3.35 mg/dl , 8.81 % P= triglyceride was observed between two groups . CONCLUSION This study suggests possible small short term benefits of garlic on dyslipidemia in type 2 diabetic patients . Garlic significantly reduced serum total cholesterol and LDL cholesterol and moderately raised HDL cholesterol as compared to placebo . Controlled Clinical Trials of longer duration are needed to assess the long term benefit of garlic on vascular and circulatory disease processes",
"BACKGROUND Garlic powder tablets have been reported to lower serum cholesterol levels . There is widespread belief among the general public that garlic powder tablets aid in controlling cholesterol levels . However , much of the prior data demonstrating the cholesterol-lowering effect of garlic tablets involved studies that were inadequately controlled . OBJECTIVE To determine the lipid-lowering effect of garlic powder tablets in patients with hypercholesterolemia . METHODS This was a r and omized , double-blind , placebo-controlled , 12-week , parallel treatment study carried out in 2 outpatient lipid clinics . Entry into the study after 8 weeks of diet stabilization required a mean low-density lipoprotein cholesterol level on 2 visits of 4.1 mmol/L ( 160 mg/dL ) or lower and a triglyceride level of 4.0 mmol/L ( 350 mg/dL ) or lower . The active treatment arm received tablets containing 300 mg of garlic powder ( Kwai ) 3 times per day , given with meals ( total , 900 mg/d ) . This is equivalent to approximately 2.7 g or approximately 1 clove of fresh garlic per day . The placebo arm received an identical-looking tablet , also given 3 times per day with meals . The main outcome measures included levels of total cholesterol , triglycerides , low-density lipoprotein cholesterol , and high-density lipoprotein cholesterol after 12 weeks of treatment . RESULTS Twenty-eight patients ( 43 % male ; mean + /- SD age , 58 + /- 14 years ) received garlic powder treatment and 22 ( 68 % male ; mean + /- SD age , 57 + /- 13 years ) received placebo treatment . There were no significant lipid or lipoprotein changes in either the placebo- or garlic-treated groups and no significant difference between changes in the placebo-treated group compared with changes in the garlic-treated patients . CONCLUSION Garlic powder ( 900 mg/d ) treatment for 12 weeks was ineffective in lowering cholesterol levels in patients with hypercholesterolemia",
"Our aim was to define any effects of confirmed garlic supplementation on the resistance of low density lipoprotein ( LDL ) to oxidation , on LDL sub-fraction composition including levels of lipoprotein(a ) , and on levels of circulating antibody to oxidised LDL , variables of interest in relation to cardiovascular risk . Additional tests were performed on sample s collected from a double blind , r and omised 6-month parallel trial in which 900 mg Kwai garlic or placebo was taken by moderately hypercholesterolaemic volunteers . Final data was analysed for 20 garlic and 11 placebo subjects with compliance of at least 75 % as determined by repeat tablet counting . EDTA plasma stabilised by sucrose was stored at -70 degrees C for up to 12 months . Lipids and apolipoproteins were determined by st and ard methods , lipoprotein(a ) by an ELISA method and LDL fraction composition by non-gradient gel electrophoresis . Oxidative resistance of LDL purified after isolation by density gradient centrifugation was assessed from oxidative resistance to copper ions determined spectrophotometrically , antibodies to oxidised LDL were determined by a microtitre plate assay and vitamin E content of plasma by HPLC . Overall lipid/lipoprotein profiles including lipoprotein(a ) were unchanged as with the parent group . LDL composition showed a trend to less dense material in both placebo and garlic groups , all differences not significant . Lag time as a marker of oxidative resistance also increased in both groups , without change in vitamin E content , all differences not significant and consistent with a placebo effect . Levels of antibodies to oxidised LDL were unchanged . The results of this study do not support the hypothesis that dietary garlic supplementation decreases the susceptibility of isolated LDL to oxidation and that patterns of LDL tractions in plasma might be involved . Levels of lipoprotein(a ) in plasma were also not changed . Other mechanisms of cardiovascular benefit are however not excluded",
"BACKGROUND Little is known about the long-term effects of garlic or micronutrient supplementation on total , HDL , and LDL cholesterol in disease-free persons . OBJECTIVE We aim ed to assess the effects of long-term supplementation with garlic and micronutrients and of short-term amoxicillin and omeprazole treatment on serum total , HDL , and LDL cholesterol in a rural Chinese population . DESIGN We conducted a r and omized , double-blind , placebo-controlled , 2 x 2 x 2 and 2 x 2 factorial study of precancerous gastric lesions in 3411 subjects in Linqu County , Sh and ong Province , China . Thirty-four subjects were r and omly selected from each of 12 treatment strata . Sera were analyzed at 3.3 and 7.3 y to measure effects on total , HDL , and LDL cholesterol after 2-wk twice-daily treatment with 1 g amoxicillin and 20 mg omeprazole and supplementation throughout the study with 1 ) 2 capsules twice daily , each containing 200 mg aged garlic extract and 1 mg steam-distilled garlic oil , or 2 ) twice-daily micronutrient capsules containing 250 mg vitamin C , 100 IU vitamin E , and 37.5 mg selenium . RESULTS Regressions adjusted for covariates indicated increases of 0.22 mmol total cholesterol/L ( P = 0.01 ) and 0.19 mmol LDL/L ( P = 0.02 ) after 7.3 y of micronutrient supplementation , but no effect of garlic supplementation or short-term amoxicillin and omeprazole treatment . CONCLUSIONS In this rural Chinese population with low meat intake and moderate cholesterol concentrations , long-term garlic supplementation had no effect on lipid profiles , whereas micronutrient supplementation was associated with small but significant increases in total and LDL-cholesterol concentrations at 7.3",
"Interventions which make serum lipoproteins less susceptible to oxidation may be antiatherogenic . The antioxidant properties of garlic which have been demonstratedin vitro led us to investigate the effects of garlic supplements on lipoprotein oxidation susceptibility in humans . Ten healthy volunteers were given 600 mg/d of garlic powder ( 6 tablets of Kwai ® ) for two weeks in a placebo-controlled , r and omized , double-blind crossover trial . We found that although serum lipid and lipoprotein levels were not lowered in this short time period , theex vivo susceptibility of apolipoprotein B-containing lipoproteins to oxidation was significantly decreased ( −34 % ) . Because garlic has been reported to beneficially affect serum lipid levels , platelet function , fibrinolysis and blood pressure , this additional effect of retarding lipoprotein oxidation may contribute to the potential antiatherosclerotic effect of garlic",
"BACKGROUND Epidemiologic studies suggest that garlic may have beneficial effects on risk factors associated with cardiovascular disease ( CVD ) . However , these findings are not unambiguously supported by r and omized placebo-controlled clinical trials . OBJECTIVE We sought to investigate the effects of a chemically well-characterized garlic preparation on biomarkers for inflammation , endothelial function , and lipid metabolism in subjects with risk factors for CVD . DESIGN This was a double-blind , r and omized , placebo-controlled trial in 90 overweight [ body mass index ( in kg/m2 ) > 24.5 ] subjects aged 40 - 75 y who smoked > 10 cigarettes/d . The subjects were r and omly assigned to 3 parallel treatment groups : garlic powder ( 2.1 g/d ) , atorvastatin ( 40 mg/d ) , or placebo . Duplicate measurements were performed at baseline and after 1 and 3 mo of treatment . Treatments were compared with analysis of covariance with baseline as the covariate , and differences between the treatments were reported as mean percentage difference and corresponding 97.5 % CI . RESULTS None of the variables showed significant differences between the garlic-treated and the placebo groups . In contrast , compared with the placebo group , atorvastatin treatment result ed in significantly lower plasma concentrations of C-reactive protein ( 20.2 % ; 1.7 % , 35.3 % ) , total cholesterol ( 37.2 % ; 33.1 % , 41.1 % ) , LDL cholesterol ( 52.7 % ; 47.9 % , 57.1 % ) , triacylglycerols ( 31.9 % ; 20.8 % , 41.5 % ) , and tumor necrosis factor alpha ( TNF-alpha ; 41.9 % ; 19.0 % , 58.3 % ) and increased the ratio of ex vivo whole blood lipopolysaccharide-stimulated to nonstimulated TNF-alpha concentrations ( 109.7 % ; 37.9 % , 218.9 % ) . CONCLUSION We conclude that a chemically well-characterized garlic preparation has no significant effect on inflammatory biomarkers , endothelial function , or lipid profile in normolipidemic subjects with risk factors for CVD",
"Early trials of garlic preparations on blood lipids mainly supported a lipid-lowering effect , whereas later well- design ed garlic tablet trials were mainly entirely None . However , enteric simulation tests suggest that this discordance may result from ineffective delivery of bioactive agents from the br and s of garlic powder ( GP ) and cyclodextrin-bound garlic oil ( GO ) tablets tested in some recent negative trials . In contrast , enteric simulation tests show that the preformed bioactive agents present in \" traditional \" gelatin capsules of GO are efficiently released , although such capsules have rarely been investigated in lipid-lowering trials . It was hypothesized that gelatin capsules of GO given to normal subjects would improve specified coronary heart disease risk factors . Effects of a GP preparation were also investigated . Subjects ( n = 51 ; men and women , mean age 27 y ) were r and omly assigned to receive either 8.2 mg/d of GO ( allyl sulfides ) or placebo for 11 wk . Another 27 subjects received garlic powder ( GP ) of similar biopotential ( 7.8 mg allicin/d ) . Outcome measures were 95 % confidence intervals ( CI ) between GO and placebo groups for differences between baseline and subsequent sample times . Men and women combined showed no significant differences save for an improved total antioxidant capacity at 6 wk ( P = 0.01 ) . Hence , no benefit from GO after 11 wk is one plausible conclusion . However , there were significant differences in effect of GO between men and women for HDL cholesterol ( HDL-C ) ( P = 0.004 ) and total cholesterol (TC)/HDL-C ( P = 0.003 ) . Women showed favorable effects in terms of CHD risk factors ( i.e. , increases in HDL-C and reductions in TC/HDL-C ) , whereas men had small adverse effects . There was a significant difference in the GO effect for glucose ( P = 0.006 ) , with a reduction seen for men and an increase for women . The gender effects were unexpected and such analyses were not planned in advance . Confirmation of these findings with larger numbers of subjects would have importance for the use of garlic against CHD and for the design of future garlic studies",
"This study examined the effects of garlic and fish-oil supplementation ( alone and in combination ) on fasting serum lipids and lipoproteins in hypercholesterolemic subjects . After an initial run-in phase , 50 male subjects with moderate hypercholesterolemia were r and omly assigned for 12 wk to one of four groups : 1 ) 900 mg garlic placebo/d + 12 g oil placebo/d ; 2 ) 900 mg garlic/d + 12 g oil placebo/d ; 3 ) 900 mg garlic placebo/d + 12 g fish oil/d , providing 3.6 g n-3 fatty acids/d ; and 4 ) 900 mg garlic/d + 12 g fish oil/d . In the placebo group , mean serum total cholesterol , low-density-lipoprotein cholesterol ( LDL-C ) , and triacylglycerols were not significantly changed in relation to baseline . Mean group total cholesterol concentrations were significantly lower with garlic+fish oil ( -12.2 % ) and with garlic ( -11.5 % ) after 12 wk but not with fish oil alone . Mean LDL-C concentrations were reduced with garlic+fish oil ( -9.5 % ) and with garlic ( -14.2 % ) but were raised with fish oil ( + 8.5 % ) . Mean triacylglycerol concentrations were reduced with garlic+fish oil ( -34.3 % ) and fish oil alone ( -37.3 % ) . The garlic groups ( with and without fish oil ) had significantly lower ratios of total cholesterol to high-density-lipoprotein cholesterol ( HDL-C ) and LDL-C to HDL-C. In summary , garlic supplementation significantly decreased both total cholesterol and LDL-C whereas fish-oil supplementation significantly decreased triacylglycerol concentrations and increased LDL-C concentrations in hypercholesterolemic men . The combination of garlic and fish oil reversed the moderate fish-oil-induced rise in LDL-C. Coadministration of garlic with fish oil was well-tolerated and had a beneficial effect on serum lipid and lipoprotein concentrations by providing a combined lowering of total cholesterol , LDL-C , and triacylglycerol concentrations as well as the ratios of total cholesterol to HDL-C and LDL-C to",
"The study was conducted on two groups of individuals . Group A consisted of 20 healthy volunteers who were fed garlic for 6 months and then followed for another 2 months without garlic . Garlic administration significantly lowered the serum cholesterol and triglycerides while raising the high-density lipoproteins . Group B consisted of 62 patients with coronary heart disease with elevated serum cholesterol . They were r and omly divided into two subgroups : B1 was fed garlic for 10 months while B2 served as a control . Garlic decreased the serum cholesterol ( p less than 0.05 ) , triglycerides ( p less than 0.05 ) and low density lipoprotein ( p less than 0.05 ) while increasing the high-density fraction ( p less than 0.001 ) . The change reached statistically significant levels at the end of 8 months and persisted for the next 2 months of follow-up . Thus , the essential oil of garlic has shown a distinct hypolipidemic action in both healthy individuals and patients of coronary heart disease",
"A double-blind crossover study comparing the effect of aged garlic extract with a placebo on blood lipids was performed in a group of 41 moderately hypercholesterolemic men [ cholesterol concentrations 5.7 - 7.5 mmol/L ( 220 - 290 mg/dL ) ] . After a 4-wk baseline period , during which the subjects were advised to adhere to a National Cholesterol Education Program Step I diet , they were started on 7.2 g aged garlic extract per day or an equivalent amount of placebo as a dietary supplement for a period of 6 mo , then switched to the other supplement for an additional 4 mo . Blood lipids , blood counts , thyroid and liver function measures , body weight , and blood pressure were followed over the entire study period . The major findings were a maximal reduction in total serum cholesterol of 6.1 % or 7.0 % in comparison with the average concentration during the placebo administration or baseline evaluation period , respectively . Low-density-lipoprotein cholesterol was also decreased by aged garlic extract , 4 % when compared with average baseline values and 4.6 % in comparison with placebo period concentrations . In addition , there was a 5.5 % decrease in systolic blood pressure and a modest reduction of diastolic blood pressure in response to aged garlic extract . We conclude that dietary supplementation with aged garlic extract has beneficial effects on the lipid profile and blood pressure of moderately hypercholesterolemic subjects",
"BACKGROUND The beneficial effect of 3-hydroxy-3-methylglutyaryl co-enzyme A reductase inhibitors on cardiovascular risk reduction has been clearly established . Concerns have been raised that lowering blood cholesterol by other hypolipidemic drugs or by a non-pharmacologic approach may have deleterious effects on psychopathologic parameters . Garlic is one of the most commonly used herbal remedies and is considered to have hypocholesterolemic as well as other cardioprotective properties . Its effect on psychopathologic parameters has never been reported . OBJECTIVE To evaluate the effect of garlic on lipid parameters and depression , impulsivity , hostility and temperament in patients with primary type 2 hyperlipidemia . METHODS In a 16 week prospect i ve double-blind placebo-controlled study , 33 patients with primary hypercholesterolemia and no evidence of cardiovascular disease were r and omly assigned to receive either garlic or placebo . Garlic in the form of alliin 22.4 mg/day was given to 13 patients , and placebo to 20 . Both groups received individual dietary counseling . The changes in lipid profile and the various psychopathologic parameters were determined at the beginning and end of the trial . The differences in lipid parameters were evaluated by Student 's t-test . The psychological data were analyzed by one-way analysis of variance ( ANOVA ) with repeated measures and Neuman-Keuls test . RESULTS No significant changes were observed in levels of total cholesterol , low density lipoprotein-cholesterol , high density lipoprotein-cholesterol and triglycerides , or in the psychopathologic parameters evaluated . CONCLUSION Short-term garlic therapy in adults with mild to moderate hypercholesterolemia does not affect either lipid levels or various psychopathologic parameters",
"BACKGROUND Aged Garlic Extract ( AGE ) reduces multiple cardiovascular risk factors , including blood pressure , cholesterol , platelet aggregation and adhesion , while stimulating nitric oxide generation in endothelial cells . However , no study has evaluated the ability of AGE to inhibit vascular calcification , a marker of plaque formation in human coronary arteries . OBJECTIVE To assess the efficacy of Aged Garlic Extract ( AGE ) on changing the rate of atherosclerosis progression as compared to placebo . DESIGN A placebo-controlled , double-blind , r and omized pilot study to determine whether the atherosclerotic plaque burden detected by electron beam tomography ( EBT ) will change at a different rate under the influence of AGE as compared to placebo . Twenty-three patients were enrolled , and 19 patients completed the study protocol . AGE 4 ml or the equivalent amount of placebo was given to subjects . Duration of the study was 1 year . S-allylcysteine ( SAC ) , one of the active compound of AGE , was measured in the blood as a compliance marker . RESULTS The mean change of the calcium score ( volumetric method ) for the AGE group ( n = 9 ) was 7.5 + /- 9.4 % over 1 year . The placebo group ( n = 10 ) demonstrated an average increase in calcium scores of 22.2 + /- 18.5 % , significantly greater than the treated cohort ( P = 0.046 ) . There were no significant differences in individual cholesterol parameters or C reactive protein between the groups . In patients r and omized to AGE , there was a nonsignificant trend for improving cholesterol/high-density lipoprotein ratio ( P = 0.07 ) and homocysteine level ( P = 0.08 ) . CONCLUSIONS This small pilot study indicates the potential ability of AGE to inhibit the rate of progression of coronary calcification , as compared to placebo over 1 year . Should these findings be extended and confirmed in larger studies , garlic may prove useful for patients who are at high risk of future cardiovascular events",
"Background hyperlipidemia as a major risk factor of atherosclerosis is treated with different drugs . Concerning length of therapy and vast majority of side effects , herbal medication may be suitable substitute for these drugs . Methods In this single-blind , placebo controlled study , lipid profiles of 150 hyperlipidemic patients in cardiology outpatient department of Shiraz University of Medical Sciences were checked at same conditions . They were divided into three equal groups r and omly ( each composing of 50 patients ) . They were given enteric-coated garlic powder tablet ( equal to 400 mg garlic , 1 mg allicin ) twice daily , anethum tablet ( 650 mg ) twice daily , and placebo tablet . All patients were put on NCEP type Π diet and Six weeks later , lipid profiles were checked . Results In garlic group : total cholesterol ( decreased by 26.82 mg/dl , 12.1 % reduction , and P-value : .000 ) , and LDL-cholesterol ( decreased by 22.18 mg/dl , 17.3 % reduction , and P-value : .000 ) dropped . HDL-cholesterol ( increased by 10.02 mg/dl , 15.7 % increase , and P-value : .000 ) increased . Although triglyceride dropped by 13.72 mg/dl ( 6.3 % ) but this was not significant statistically ( P-value : .222 ) . In anethum group : surprisingly , triglyceride increased by 14.74 mg/dl ( 6.0 % ) . Anethum could reduce total cholesterol by 0.4 % and LDL-cholesterol by 6.3 % but these were not significant statistically ( P-value : .828 , and .210 , respectively ) . Conclusion Anethum has no significant effect on lipid profile , but garlic tablet has significant favorable effect on cholesterol , LDL-cholesterol , and HDL-cholesterol . Garlic may play an important role in therapy of hypercholesterolemia",
"Garlic has been known to have antiplatelet properties . Because of the lack of major clinical data regarding the safety of concomitant use of garlic supplements and anticoagulants , we decided to evaluate the safety of using garlic extract along with oral anticoagulation therapy . During this project we tested aged garlic extract ( AGE ) , a commercial garlic preparation , with warfarin ( Coumadin ) . Sixty-six ( 66 ) patients were screened for a double-blind , r and omized , placebo-controlled pilot study . Fifty-two ( 52 ) patients were r and omized for the project . Forty-eight patients ( 30 men and 18 women , with a mean age of 56+/-10 years ) completed the study . Eighteen patients ( 14 before r and omization , 4 after r and omization ) were dropped from the study . The study medication ( AGE or placebo ) was administered at a dose of 5 mL twice a day for 12 wk . Potential bleeding and thromboembolic episodes were monitored . There was no evidence of increased hemorrhage in either the placebo or the AGE group . Adverse events included headache , fatigue , colds , and dizziness . However , no significant difference was found in the incidence of these minor adverse events between the groups . Thus , the adverse events are unlikely to be attributable to AGE . The results suggest that AGE is relatively safe and poses no serious hemorrhagic risk for closely monitored patients on warfarin oral anticoagulation therapy . Although the risk-benefit ratio of AGE use needs to be considered carefully when warfarin therapy is necessary , its positive effects may be beneficial to people with a high-risk background or who are taking cardiovascular medications",
"The present study aim ed at investigating the cholesterol-lowering and side effects of garlic enteric coated tablets in comparison with placebo tablets . The study is a r and omized double-blinded crossover design involving 116 volunteers . However , 16 of them did not complete the study . The remaining 100 volunteers were divided into two groups : 45 were in the trial group and the remaining 55 in the control group . The volunteers in the trial group were asked to take garlic tablets in the first three months , placebo in the second three months and discontinue all tablets in the last three months , while the volunteers in the control group started with three months of placebo followed by three months of garlic tablets and ended up with three months of tablets discontinuity . The results showed that there were no significant differences in the total serum cholesterol levels between the two groups at the end of three months or six months of the study . Side effects included headache , itching and complaints of garlic smell . No serious side effects relating to liver , kidney functions or hematologic side effects were",
"OBJECTIVE To determine whether garlic extract therapy is efficacious and safe in children with hypercholesterolemia . DESIGN R and omized , double-blind , placebo-controlled clinical trial . SETTING Specialized pediatric lipid disorders ambulatory clinic . PARTICIPANTS Thirty pediatric patients , aged 8 to 18 years , who had familial hyperlipidemia and a minimum fasting total cholesterol level greater than 4.8 mmol/L ( > 185 mg/dL ) . INTERVENTION An 8-week course of a commercially available garlic extract ( Kwai [ Lichtwer Pharma , Berlin , Germany ] , 300 mg , 3 times a day ) or an identical placebo . MAIN OUTCOME MEASURES Absolute and relative changes in fasting lipid profile parameters . RESULTS The groups were equivalent at baseline and compliance was similar in the 2 groups ( P = .45 ) . There was no significant relative attributable effect of garlic extract on fasting total cholesterol ( + 0.6 % [ 95 % confidence interval , -5.8 % to + 6.9%1 ) or low-density lipoprotein cholesterol ( -0.5 % [ 95 % confidence interval , -8.7 % to + 7.6 % ] ) . The lower limits of the confidence intervals did not include -10 % , the minimum relative attributable effect believed to be clinical ly important . Likewise , no significant effect was seen on the levels of high-density lipoprotein , triglycerides , apolipoprotein B-100 , lipoprotein ( a ) , fibrinogen , homocysteine , or blood pressure . There was a small effect on apolipoprotein A-I ( + 10.0 % [ 95 % confidence interval , + 1.2 % to + 16.5 % ] P=.03 ) . There were no differences in adverse effects between groups . CONCLUSION Garlic extract therapy has no significant effect on cardiovascular risk factors in pediatric patients with familial hyperlipidemia",
"Lipid management is well established as an effective preventive and management tool for cardiovascular disease ( CVD ) . Health cl aims regarding the cholesterol lowering benefits of garlic are widespread . However , the clinical trial data are inconsistent . The effect of two doses of a commercial garlic preparation on plasma lipids were evaluated , compared to a placebo , in moderately hypercholesterolemic adults ( baseline low density lipoprotein cholesterol (LDL-C)=157 . 4+/-18.7 , mean+/-S.D. ) . Fifty-one adults , aged 51.8+/-8.3 years participated in a double-blind , placebo-controlled , parallel treatment trial conducted in an outpatient research clinic . They were r and omized to a placebo or a garlic botanical blend providing 500 or 1000 mg dehydrated garlic powder/day ( three groups , 16 - 18 subjects per group ) . Plasma lipids were assessed every 2 weeks for 12 weeks . The study was design ed with sufficient power to detect a 10 % relative decline in LDL-C. The absolute mean changes in LDL-C over 12 weeks were 0.0+/-4.3 , + 1.4+/-4.8 , and -10.1+/-6.8 mg/dl for the placebo , half-dose and full-dose , respectively . In the full-dose group , the LDL-C decrease of 6.1 % was not significantly different from the other groups ( P=0.5 ) . No significant differences were observed for total- or high-density lipoprotein cholesterol ( HDL-C ) , or triacylglycerol levels . In conclusion , the garlic powder preparation used in this study among moderately hypercholesterolemic adults did not significantly effect plasma lipids levels . There was no indication of a grade d affect by garlic dose over the range of 0 , 500 and 1000 mg/day . A small ( LDL-C levels or a threshold effect requiring larger doses are not eliminated by this study",
"PURPOSE To assess the effects of st and ardized garlic powder tablets on serum lipids and lipoproteins , glucose , and blood pressure . SUBJECTS AND METHODS Forty-two healthy adults ( 19 men , 23 women ) , mean age of 52 + /- 12 years , with a serum total cholesterol ( TC ) level of greater than or equal to 220 mg/dL received , in a r and omized , double-blind fashion , either 300 mg three times a day of st and ardized garlic powder in tablet form or placebo . Diets and physical activity were unchanged . This study was conducted in an outpatient , clinical research unit . RESULTS The baseline serum TC level of 262 + /- 34 mg/dL was reduced to 247 + /- 40 mg/dL ( p st and ard garlic treatment . Corresponding values for placebo were 276 + /- 34 mg/dL before and 274 + /- 29 mg/dL after placebo treatment . Low-density lipoprotein cholesterol ( LDL-C ) was reduced by 11 % by garlic treatment and 3 % by placebo ( p high-density lipoprotein cholesterol , triglycerides , serum glucose , blood pressure , and other monitored parameters . CONCLUSIONS Treatment with st and ardized garlic 900 mg/d produced a significantly greater reduction in serum TC and LDL-C than placebo . The garlic formulation was well tolerated without any odor problems",
"OBJECTIVE The authors assessed the effects of an enteric-coated Thai garlic extract tablet st and ardized for allicin-releasing potential on serum lipid levels in hypercholesterolemic subjects . SUBJECTS AND METHOD The authors performed a r and omized , double-blind , placebo-controlled trial in 136 hypercholesterolemic subjects ( cholesterol concentrations > or = 5.2 mmol/L ; mean age + /- SD : 47.0 + /- 6.6 yr ) . All subjects were given dietary advice to lower fat intake within 4 weeks and were advised to eat normally during the study period . The subjects were r and omly assigned to receive an enteric-coated Thai garlic extract tablet once daily ( st and ardized to 1.12 % allicin or 5.6 mg/tablet ) , or placebo after the evening meal for 12 weeks . Seventy subjects ( 32.9 % male ; mean age + /- SD and BMI of 47.0 + /- 6.6 yr and 24.6 + /- 3.3 kg/m2 ) received the garlic extract treatment while 66 subjects ( 37.9 % male , mean age + /- SD and BMI of 47.0 + /- 6.0 yr and 24.3 + /- 3.4 kg/m2 ) received placebo . RESULTS There were no statistically significant changes in serum total cholesterol , triglycerides , low-density lipoprotein ( LDL ) cholesterol and high-density lipoprotein ( HDL ) cholesterol after the 12-week treatment as analyzed on repeated measures by analysis of variance . In addition , no changes in plasma glucose , liver and renal functions were found . CONCLUSIONS Treatment with an enteric garlic-coated Thai garlic extract and dietary advice did not produce any significant changes in lipid levels in subjects with hypercholesterolemia",
"The ingestion of garlic has been reported to have many cardiovascular effects , including a reduction in plasma cholesterol concentration and the susceptibility of LDL to oxidation . A double-blind , placebo-controlled , r and omised crossover study was conducted in subjects with mild to moderate hypercholesterolaemia who were subject to strict dietary supervision and assessment . After a baseline dietary period of 28 days , subjects took Kwai garlic powder tablets 300 mg three times daily or matching placebo for 12 weeks , followed by 28 days washout , followed by a 12 weeks crossover on the alternative preparation . In the analysis hypercholesterolaemia was defined as those subjects in the range 5.5 - 8.05 mmol/l . Three subjects were withdrawn , one allocated to garlic and complaining of garlic body odour , one using placebo having intercurrent health problems , and one with a baseline cholesterol below 5.5 mmol/l , yielding analysable results in 28 subjects . Comparing the period on garlic with that on placebo , there were no significant differences in plasma cholesterol , LDL cholesterol , HDL cholesterol , plasma triglycerides , lipoprotein(a ) concentrations , or blood pressure . Mean LDL cholesterol concentration was 4.64 + /- 0.52 mmol/l on garlic and 4.60 + /- 0.59 mmol/l on placebo . There was no demonstrable effect of garlic on oxidisability of LDL , on the ratio of plasma lathosterol/cholesterol ( a measure of cholesterol synthesis ) , nor on LDL receptor expression in lymphocytes . This study found no demonstrable effect of garlic ingestion on lipids and lipoproteins",
"OBJECTIVE This study was design ed to determine the effect of garlic tablet ( Garlet ) on plasma lipids , and platelet aggregation and the efficacy of this treatment in the prevention of preeclampsia . STUDY DESIGN In a r and omized , single-blind , placebo-controlled study , 100 primigravidas with positive roll-over test were treated with daily doses of 800 mg Garlet/day ( n=50 ) or 800mg/day placebo ( n=50 ) during the third trimester of pregnancy . Serum total cholesterol , LDL- and HDL-cholesterol , triglyceride , and platelet aggregation were measured before and after the treatment . Blood pressure , weight , and edema were also examined during the entire study period . RESULTS In the case group , there was no significant difference in the means of total cholesterol , HDL , LDL , and triglyceride before and after the experiment . Furthermore , the inhibition of platelet aggregation did not show any significant difference before and after the treatment . There were not any significant difference in the means of HDL , LDL , triglyceride , inhibition of platelet aggregation , the means of systolic and diastolic blood pressure and the mean arterial blood pressure ( MAP ) , between the two groups , but there was a significant difference in the means of total cholesterol ( P=0.038 ) and hypertension alone ( P=0.043 ) . CONCLUSION The administration of 800mg/day of Garlet during the third trimester of pregnancy was effective in reducing the occurrence of hypertension alone , but it was no effective in preventing of preeclampsia",
"BACKGROUND Garlic is widely promoted as a cholesterol-lowering agent , but efficacy studies have produced conflicting results . Garlic supplements differ in bioavailability of key phytochemicals . We evaluated the effect of raw garlic and 2 commonly used garlic supplements on cholesterol concentrations in adults with moderate hypercholesterolemia . METHODS In this parallel- design trial , 192 adults with low-density lipoprotein cholesterol ( LDL-C ) concentrations of 130 to 190 mg/dL ( 3.36 - 4.91 mmol/L ) were r and omly assigned to 1 of the following 4 treatment arms : raw garlic , powdered garlic supplement , aged garlic extract supplement , or placebo . Garlic product doses equivalent to an average-sized garlic clove were consumed 6 d/wk for 6 months . The primary study outcome was LDL-C concentration . Fasting plasma lipid concentrations were assessed monthly . Extensive chemical characterization of study material s was conducted throughout the trial . RESULTS Retention was 87 % to 90 % in all 4 treatment arms , and chemical stability of study material s was high throughout the trial . There were no statistically significant effects of the 3 forms of garlic on LDL-C concentrations . The 6-month mean ( SD ) changes in LDL-C concentrations were + 0.4 ( 19.3 ) mg/dL ( + 0.01 [ 0.50 ] mmol/L ) , + 3.2 ( 17.2 ) mg/dL ( + 0.08 [ 0.44 ] mmol/L ) , + 0.2 ( 17.8 ) mg/dL ( + 0.005 [ 0.46 ] mmol/L ) , and -3.9 ( 16.5 ) mg/dL ( -0.10 [ 0.43 ] mmol/L ) for raw garlic , powdered supplement , aged extract supplement , and placebo , respectively . There were no statistically significant effects on high-density lipoprotein cholesterol , triglyceride levels , or total cholesterol-high-density lipoprotein cholesterol ratio . CONCLUSIONS None of the forms of garlic used in this study , including raw garlic , when given at an approximate dose of a 4-g clove per day , 6 d/wk for 6 months , had statistically or clinical ly significant effects on LDL-C or other plasma lipid concentrations in adults with moderate hypercholesterolemia",
"Summary For the first time , a weak clinical efficacy of a 12-week therapy with garlic powder ( daily dose , 800 mg ) is demonstrated in patients with peripheral arterial occlusive disease stage II . The increase in walking distance in the verum group by 46 m ( from 161.0 ± 65.1 to 207.1 ± 85.0 m ) was significantly higher ( P physical therapy twice a week . The diastolic blood pressure , spontaneous thrombocyte aggregation , plasma viscosity , and cholesterol concentration also decreased significantly . Body weight was maintained . It is quite interesting that the garlic-specific increase in walking distance did not appear to occur until the 5th week of treatment , connected with a simultaneous decrease in spontaneous thrombocyte aggregation . Therefore , garlic may be an appropriate agent especially for the long-term treatment of an incipient intermittent claudication",
"A double-blind study of 40 hypercholesterolaemic out- patients was carried out over a period of four months to examine the effects of a garlic powder preparation*. The drug group received 900 mg garlic powder per day , equivalent to 2,700 mg of fresh garlic . During the therapy , the drug group showed significantly lower total cholesterol , triglycerides and blood pressure than those of the placebo group . In addition , results of a self-evaluation question naire indicated that patients in the drug group had a greater feeling of ' well-being '",
"OBJECTIVES To test the hypothesis that a garlic supplement alters plasma lipoproteins , postpr and ial lipemia , low-density lipoprotein ( LDL ) size and high-density lipoprotein ( HDL ) subclass distribution differently in 50 moderately hypercholesterolemic subjects classified as LDL subclass pattern A or B. BACKGROUND Garlic has been variably reported to reduce or not affect plasma cholesterol values . Low-density lipoprotein pattern B is a common inherited disorder of lipoprotein metabolism that has been shown to have a significantly greater response to several lipid lowering treatments including low fat diet when compared with LDL pattern A individuals . METHODS A double blind , r and omized , placebo controlled trial in an outpatient lipid research clinic was performed and included fifty moderately hypercholesterolemic subjects ( mean LDL cholesterol = 166 + /- 22 mg/dl ) classified as LDL subclass pattern A ( predominantly large LDL , n = 22 ) or B ( predominantly small LDL , n = 28 ) . Following a two-month stabilization period , subjects were r and omly assigned to a placebo or 300 mg three times a day of a st and ardized garlic tablet for three months . RESULTS For all subjects , LDL pattern A and B subjects combined , garlic treatment for three months result ed in no significant change in total cholesterol , LDL cholesterol , HDL cholesterol , HDL subclass distribution , postpr and ial triglycerides , apolipoprotein B , lipoprotein ( a ) ( Lp[a ] ) , LDL peak particle diameter or LDL subclass distribution . There was no significant difference in response for the same parameters among subjects classified as LDL pattern A or B with the exception of significantly greater ( p = 0.01 ) reduction in mean peak particle diameter in pattern A subjects treated with either garlic or placebo . There was no significant change in LDL subclass distribution . CONCLUSIONS This investigation confirms that garlic therapy has no effect on major plasma lipoproteins and further , that it has no impact on HDL subclasses , Lp(a ) , apolipoprotein B , postpr and ial triglycerides or LDL subclass distribution . Garlic may have a greater effect on LDL particle diameter in LDL pattern A compared with pattern B subjects . This difference was not reflected in other plasma lipid measurements",
"Recent studies have cast doubt on the proposed lipid-lowering and blood pressure-lowering effects of garlic . We tested the effect of dried garlic ( Allium sativum ) powder on blood lipids , blood pressure and arterial stiffness in a 12-week r and omised , double-blind , placebo-controlled trial . Seventy-five healthy , normo-lipidaemic volunteers ( men and women aged 40 - 60 years ) were assigned to dried garlic powder tablets ( 10.8 mg alliin ( 3-(2-propenylsulfinyl)-L-alanine)/d , corresponding to about three garlic cloves ) or placebo . Sixty-two subjects were eligible for the per- protocol analysis . The primary outcome measure was serum total cholesterol concentration . Secondary outcome measures were LDL-cholesterol , HDL-cholesterol and triacylglycerol concentrations , blood pressure and arterial stiffness ( assessed by pulse wave velocity ) . No significant differences between the garlic and placebo groups were detected for any of the outcome measures . However , garlic powder was associated with a near-significant decrease ( 12 % ) in triacylglycerol concentration ( P=0.07 ) . In conclusion , garlic powder tablets have no clinical ly relevant lipid-lowering and blood pressure-lowering effects in middle-aged , normo-lipidaemic individuals . The putative anti-atherosclerotic effect of garlic may be linked to risk markers other than blood lipids",
"Clinical trials have shown that garlic can reduce elevated blood cholesterol levels . No information , however , exist on its effects on normal lipid patterns . Therefore a r and omised , double-blind , placebo-controlled trial was conducted to determine the effects on blood lipids of 15 weeks ' medication of garlic ( 600 mg dried garlic powder per day , Kwai , Lichtwer Pharma Berlin , st and ardised on 1.3 % allicin ) in 68 normal volunteers . During a two week \" wash-out \" period all measurements were stable . There was a significant drop ( from 223 to 214mg/dl ) in total cholesterol after 10 weeks ' medication , triglycerides decreased numerically ( from 124 to 118mg/dl ) without reaching the level of significance . Blood pressure remained constant throughout . No changes occurred in the placebo group . It is concluded that the medication of garlic induces changes in blood lipids , even if these variables had been normal to start with",
"The effects of dried garlic on blood lipids , apolipoproteins and blood coagulation parameters in hyperlipemic patients were studies in two controlled , r and omized , double-blind studies . Both studies comprised placebo and therapy periods of 6 weeks each . The doses administered were 3 X 198 mg in Study I ( 34 patients ) and 3 X 450 mg in Study II ( 51 patients ) . In both studies , the following serum parameters were measured every 3 weeks : total cholesterol , HDL ( high density lipoprotein)- and LDL ( low density lipoprotein)-cholesterol , triglycerides and several safety parameters . In addition , apolipoproteins A and B , euglobulin lysis time , fibrin split products , prothrombin time , whole blood coagulation time and fibrinogen levels were determined in the second study only . The results indicated that neither dosage of dried garlic showed any significant effect on any of the parameters measured . It is therefore concluded that , if there is any effect of garlic on the parameters measured , it is not apparent when using a dried preparation in the dosage studied",
"Endothelium-dependent vasodilation is impaired and predicts the risk of a coronary event in patients with coronary artery disease ( CAD ) . Oxidant stress and increased systemic inflammation may contribute to this endothelial dysfunction . Aged garlic extract ( AGE ) contains antioxidant compounds and increases nitric oxide production and decreases the output of inflammatory cytokines from cultured cells . The aim of this study was to test the effect of treatment with AGE on brachial artery flow mediated endothelium-dependent dilation ( FMD ) and circulating markers of oxidative stress and systemic inflammation . The trial included 15 men with angiographically proven CAD in a r and omized , placebo-controlled , cross-over design with 2-week treatment and washout periods . During AGE supplementation , FMD increased ( 44 % ) significantly ( p = 0.04 ) from the baseline and mainly in men with lower baseline FMD . Levels of FMD at the end of AGE treatment were significantly ( p = 0.03 ) higher compared with the corresponding levels at the end of placebo treatment when the variation in baseline body weight was taken into account . Markers of oxidant stress ( plasma oxidized low density lipoprotein and peroxides ) , systemic inflammation ( plasma C-reactive protein ad interleukin-6 ) and endothelial activation ( VCAM-1 ) did not change significantly during the study . These data suggest that short-term treatment with AGE may improve impaired endothelial function in men with CAD treated with aspirin and a statin . Whether improvement in endothelial function decreases the risk of future cardiovascular events remains to be determined",
"Objective : To evaluate the hypocholesterolemic effect of an enteric-coated garlic supplement st and ardized for allicin-releasing potential in mild to moderate hypercholesterolemic patients . Methods : A double-blind r and omized , placebo-controlled intervention study was conducted in 46 hypercholesterolemic subjects who had failed or were not compliant with drug therapy . Each subject was given dietary counseling to lower fat intake and enteric-coated Australian garlic powder tablets with 9.6 mg allicin-releasing potential or matching placebo tablets . Results : After 12 weeks , the garlic supplement group ( n=22 ) had a significant reduction in total cholesterol ( TC , −0.36 mmol/L , −4.2 % ) and LDL-cholesterol ( LDL-C , −0.44 mmol/L , −6.6 % ) while the placebo group ( n=24 ) had a non-significant increase in TC ( 0.13 mmol/L , 2.0 % ) and LDL-C ( 0.18 mmol/L , 3.7 % ) . HDL-cholesterol was significantly increased in the placebo group ( 0.09 mmol/L , 9.1 % ) , compared to the garlic group ( −0.02 mmol/L , −0.9 % ) , and no significant difference in triglycerides or in LDL/HDL ratio was observed between groups . Conclusions : The study demonstrates that enteric-coated garlic powder supplements with 9.6 mg allicin-releasing potential may have value in mild to moderate hypercholesterolemic patients when combined with a low fat diet . Taken with other evidence , the efficacy of garlic for lipoprotein metabolism might require allicin bioavailability to be enhanced through the use of , for example , an enteric-coated dose form . If this is the case , the possibility remains that greater hypocholesterolemic efficacy may be evident at a higher allicin dose . Also noteworthy in this study was a small reduction in energy intake with garlic compared with placebo , attributable to reduction in fat , carbohydrate and alcohol intakes . This may also have contributed to the effects on blood lipids . This study suggests that garlic supplementation has a cholesterol-lowering effect , which may be mediated by direct action of a biologically active compound or compounds and in part through the effect on food and nutrient intake",
"Thirty patients with coronary artery disease ( CAD ) were administered garlic ( study group ) while another 30 patients received the placebo ( control group ) . Various risk parameters were determined at 1.5 and 3 months of garlic administration . Garlic , administered in a daily dose of 2 x 2 capsules ( each capsule containing ethyl acetate extract from 1 g peeled and crushed raw garlic ) , reduced significantly total serum cholesterol and triglycerides , and increased significantly HDL-cholesterol and fibrinolytic activity . There was no effect on the fibrinogen and glucose levels . In vitro effects of the garlic oil on platelet aggregation ( PAg ) and eicosanoid metabolism were examined ; it inhibited PAg induced by several platelet agonists , and also platelet thromboxane formation . Two important paraffinic polysulphides - diallyl disulphide ( DADS ) and diallyl trisulphide ( DATS ) - derived from garlic and are usual constituents of garlic oil , showed antiplatelet activity , and also inhibited platelet thromboxane formation . In this respect DATS was more potent than DADS . The nature of inhibition of PAg by DATS was found to be reversible",
"Significant positive effects could be achieved in a placebo-controlled double-blind study through the administration of 800 mg of garlic powder over a period of four weeks . Spontaneous thrombocyte aggregation disappeared , the microcirculation of the skin increased by 47.6 % ( from 0.63 + /- 0.13 to 0.93 + /- 0.22 mm/s ) , plasma viscosity decreased by 3.2 % ( from 1.25 + /- 0.34 to 1.21 + /- 0.43 mPas ) , diastolic blood pressure by 9.5 % ( from 74 + /- 9 to 67 + /- 5 mmHg ) , and blood glucose concentration by 11.6 % ( from 89.4 + /- 8.8 to 79.0 + /- 11.9 mg/dl ) . The vascular protection of garlic as atherosclerosis prevention by influencing the mentioned risk parameters for cardiovascular diseases must be pointed out . Especially interesting is the thrombocyte aggregation inhibiting effect . Thus , the application of garlic may be useful in case of acetylsalicyclic acid intolerance",
"Forty-seven non-hospitalised patients with mild hypertension took part in a r and omised , placebo-controlled , double-blind trial conducted by 11 general practitioners . The patients who were admitted had diastolic blood pressures between 95 and 104 mmHg after a two-week acclimatization phase . The patients then took either a preparation of garlic powder ( Kwai ) or a placebo of identical appearance for 12 weeks . Blood pressure and plasma lipids were monitored during treatment after four , eight and 12 weeks . Significant differences between the placebo and the drug group were found during the course of therapy . For example , the supine diastolic blood pressure in the group having garlic treatment fell from 102 to 91 mmHg after eight weeks ( p less than 0.05 ) and to 89 mmHg after 12 weeks ( p less than 0.01 ) . The serum cholesterol and triglycerides were also significantly reduced after eight and 12 weeks of treatment . In the placebo group , on the other h and , no significant changes occurred",
"Most trials of bulb garlic and garlic powder tablets indicate reduced coronary heart disease ( CHD ) risk in elevated-risk subjects . Most persons taking garlic supplements lack overt risk of CHD . However , no trials have tested steam-distilled garlic oil ( GO ) capsules with healthy subjects . The objectives of the present r and omized , double-blind , placebo-controlled study were to determine whether GO capsules reduce CHD risk in trained male runners . Twenty-seven volunteers ( mean age , 28.8 years ) completed the study . Each took 12.3 mg/day GO ( or placebo ) capsules for 16 weeks . Main outcome measures were 95 % confidence intervals ( CIs ) between GO and placebo groups for differences in changes of blood pressure ( BP ) , plasma lipids , total antioxidant status ( TAS ) , low-density lipoprotein ( LDL ) composition and blood clotting factors . Principal results as mean differences ( 95 % CI ) between GO and placebo are : pulse , 2.9 beats/min ( −0.8 to 6.7 ) , P= 0.12 ; systolic BP , −4.5 mmHg ( −10.8 to 1.9 ) , P= 0.16 ; plasma total cholesterol , 0.01 mmol/l ( −0.34 to 0.37 ) , P= 0.95 ; plasma triglycerides , −0.20 mmol/l ( −0.43 to 0.03 ) , P= 0.09 ; plasma TAS , 45 μmol Trolox equivalent/l ( −35 to 124 ) , P= 0.26 ; LDL density , 0.0019 g/ml ( −0.0005 to 0.0043 ) , P= 0.12 ; LDL triglycerides/protein , −0.078 mg/mg ( −0.149 to −0.007 ) , P= 0.03 ; LDL cholesterol/protein , −0.24 mg/mg ( −0.69 to 0.22 ) , P= 0.3 ; LDL TAS/triglycerides , 29 nmol/mg ( 11 , 68 ) , P= 0.15 ; prothrombin time , 0.99 s ( −0.36 to 2.35 ) , P= 0.14 ; partial thromboplastin time , 3.0 s ( −1.0 to 7.1 ) , P= 0.13 . Results were None statistically . Trends with GO were mostly towards lower CHD risk , and a larger study ( ~150 subjects ) is required to test their validity",
"This study evaluated the effect of a dried garlic powder preparation , st and ardised to 1.3 % alliin , on the composition of plasma lipoproteins and erythrocyte membranes . Forty volunteers , aged 70 years and over , took 600 mg of garlic powder per day for three months . In participants with initially normal plasma cholesterol levels ( CH less than 200 mg/dl ; n = 11 ) after three months of garlic tablet administration , little or no change in CH values was registered , as for most of the other parameters . In contrast , in volunteers with initially elevated CH levels ( CH greater than 200 mg/dl , n = 29 ) , the CH levels were reduced by -7.7 % ( p less than 0.001 ) . This reduction took place primarily in the esterified cholesterol fraction ( -12 % , p less than 0.001 ) , whereas free cholesterol concentrations were not altered significantly . Triglycerides ( -15.9 % , p less than 0.05 ) and plasma choline phospholipids ( -4.6 % , p less than 0.01 ) were also reduced . No change of the plasma LDL-CH to HDL-CH ratio was observed in this group . Based on the weight of lyophilised , haemoglobin-free erythrocytes , the mean membrane concentration of phospholipids and cholesterol in the total cohort ( n = 40 ) increased by 5.7 % ( p less than 0.001 ) and 6.1 % ( p less than 0.01 ) , respectively . These increases were more pronounced the lower the body mass indices ( kg/m2 ) were , and the longer the duration of garlic administration was . The molar ratio of membrane phospholipids to cholesterol remained unchanged . The results are discussed with regard to a possible role of the garlic-induced membrane effects in the plasma lipid-lowering potency of garlic and preparations made from it"
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BACKGROUND After cardiac surgery , physical therapy is a routine procedure delivered with the aim of preventing postoperative pulmonary complications . OBJECTIVES To determine if preoperative physical therapy with an exercise component can prevent postoperative pulmonary complications in cardiac surgery patients , and to evaluate which type of patient benefits and which type of physical therapy is most effective . SEARCH METHODS Search es were run on the Cochrane Central Register of Controlled Trials ( CENTRAL ) on the Cochrane Library ( 2011 , Issue 12 ) ; MEDLINE ( 1966 to 12 December 2011 ) ; EMBASE ( 1980 to week 49 , 2011 ) ; the Physical Therapy Evidence Data base ( PEDro ) ( to 12 December 2011 ) and CINAHL ( 1982 to 12 December 2011 ) . SELECTION CRITERIA R and omised controlled trials or quasi-r and omised trials comparing preoperative physical therapy with no preoperative physical therapy or sham therapy in adult patients undergoing elective cardiac surgery . DATA COLLECTION AND ANALYSIS Data were collected on the type of study , participants , treatments used , primary outcomes ( postoperative pulmonary complications grade 2 to 4 : atelectasis , pneumonia , pneumothorax , mechanical ventilation > 48 hours , all-cause death , adverse events ) and secondary outcomes ( length of hospital stay , physical function measures , health-related quality of life , respiratory death , costs ) . Data were extracted by one review author and checked by a second review author . Review Manager 5.1 software was used for the analysis . MAIN RESULTS Eight r and omised controlled trials with 856 patients were included . Three studies used a mixed intervention ( including either aerobic exercises or breathing exercises ) ; five studies used inspiratory muscle training . Only one study used sham training in the controls . Patients that received preoperative physical therapy had a reduced risk of postoperative atelectasis ( four studies including 379 participants , relative risk ( RR ) 0.52 ; 95 % CI 0.32 to 0.87 ; P = 0.01 ) and pneumonia ( five studies including 448 participants , RR 0.45 ; 95 % CI 0.24 to 0.83 ; P = 0.01 ) but not of pneumothorax ( one study with 45 participants , RR 0.12 ; 95 % CI 0.01 to 2.11 ; P = 0.15 ) or mechanical ventilation for > 48 hours after surgery ( two studies with 306 participants , RR 0.55 ; 95 % CI 0.03 to 9.20 ; P = 0.68 ) . Postoperative death from all causes did not differ between groups ( three studies with 552 participants , RR 0.66 ; 95 % CI 0.02 to 18.48 ; P = 0.81 ) . Adverse events were not detected in the three studies that reported on them . The length of postoperative hospital stay was significantly shorter in experimental patients versus controls ( three studies with 347 participants , mean difference -3.21 days ; 95 % CI -5.73 to -0.69 ; P = 0.01 ) . One study reported a reduced physical function measure on the six-minute walking test in experimental patients compared to controls . One other study reported a better health-related quality of life in experimental patients compared to controls . Postoperative death from respiratory causes did not differ between groups ( one study with 276 participants , RR 0.14 ; 95 % CI 0.01 to 2.70 ; P = 0.19 ) . Cost data were not reported on . AUTHORS ' CONCLUSIONS Evidence derived from small trials suggests that preoperative physical therapy reduces postoperative pulmonary complications ( atelectasis and pneumonia ) and length of hospital stay in patients undergoing elective cardiac surgery . There is a lack of evidence that preoperative physical therapy reduces postoperative pneumothorax , prolonged mechanical ventilation or all-cause deaths
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"AIMS To compare 19 risk score algorithms with regard to their validity to predict 30-day and 1-year mortality after cardiac surgery . METHODS AND RESULTS Risk factors for patients undergoing heart surgery between 1996 and 2001 at a single centre were prospect ively collected . Receiver operating characteristics ( ROC ) curves were used to describe the performance and accuracy . Survival at 1 year and cause of death were obtained in all cases . The study included 6222 cardiac surgical procedures . Actual mortality was 2.9 % at 30 days and 6.1 % at 1 year . Discriminatory power for 30-day and 1-year mortality in cardiac surgery was highest for logistic ( 0.84 and 0.77 ) and additive ( 0.84 and 0.77 ) European System for Cardiac Operative Risk Evaluation ( EuroSCORE ) algorithms , followed by Clevel and Clinic ( 0.82 and 0.76 ) and Magovern ( 0.82 and 0.76 ) scoring systems . None of the other 15 risk algorithms had a significantly better discriminatory power than these four . In coronary artery bypass grafting (CABG)-only surgery , EuroSCORE followed by New York State ( NYS ) and Clevel and Clinic risk score showed the highest discriminatory power for 30-day and 1-year mortality . CONCLUSION EuroSCORE , Clevel and Clinic , and Magovern risk algorithms showed superior performance and accuracy in open-heart surgery , and EuroSCORE , NYS , and Clevel and Clinic in CABG-only surgery . Although the models were originally design ed to predict early mortality , the 1-year mortality prediction was also reasonably accurate",
"The role of pre-operative short-term pulmonary rehabilitation in patients with chronic obstructive pulmonary disease who undergo coronary artery bypass graft surgery has been assessed for the first time prospect ively . Forty-five patients posted for coronary artery bypass graft surgery were r and omised to receive either short-term pulmonary rehabilitation ( group I ) or no such programme ( group II ) . Patients of both the groups were evenly matched with respect to age , sex , body surface area , duration and severity of chronic obstructive pulmonary disease and coronary artery disease . Normal individuals who evenly matched with the study group were assessed for normal respiratory function parameters . Pre-operative and post-operative peak expiratory flow rate , inspiratory capacity , post-operative ventilation time , post-operative pulmonary complication and hospital stay were determined in both the groups . Peak expiratory flow rate ( 220.0 + /- 12.9 and 324.3 + /- 84.3 in group I , 218.0 + /- 16.4 and 260.5 + /- 35.2 in group II ) and inspiratory capacity ( 844.0 + /- 147.4 and 1100.0 + /- 158.1 in group I , 830.0 + /- 117.4 and 1090 + /- 137 in group II ) were significantly lower before and after surgery respectively in both groups compared to normal values . Even though both groups showed a significant rise in post-operative peak expiratory flow rate and inspiratory capacity after surgery , the post-operative peak expiratory flow rate and inspiratory capacity in group I was significantly higher than in group II . In group I , the post-operative ventilation time ( 24.5 + /- 6.00 hours ) , post-operative complications ( n = 4 ) and hospital stay ( 12.4 + /- 3.6 days ) were significantly lower than in group II ( 35.2 + /- 22.3 hours , n = 11 , 18.8 + /- 6.6 days respectively ) . These data suggest that short-term pulmonary rehabilitation is feasible and effective in improving pulmonary functions before and after surgery and in reducing surgical morbidity and cost of medical care significantly",
"CONTEXT Postoperative pulmonary complications ( PPCs ) after coronary artery bypass graft ( CABG ) surgery are a major source of morbidity and mortality , and increase length of hospital stay and re source utilization . The prehospitalization period before CABG surgery may be used to improve a patient 's pulmonary condition . The efficacy of preoperative inspiratory muscle training ( IMT ) in reducing the incidence of PPCs in high-risk patients undergoing CABG surgery has not yet been determined . OBJECTIVE To evaluate the prophylactic efficacy of preoperative IMT on the incidence of PPCs in high-risk patients scheduled for elective CABG surgery . DESIGN , SETTING , AND PATIENTS A single-blind , r and omized clinical trial conducted at the University Medical Center Utrecht , Utrecht , the Netherl and s , with enrollment between July 2002 and August 2005 . Of 655 patients referred for elective CABG surgery , 299 ( 45.6 % ) met criteria for high risk of developing PPCs , of whom 279 were enrolled and followed up until discharge from hospital . INTERVENTION Patients were r and omly assigned to receive either preoperative IMT ( n = 140 ) or usual care ( n = 139 ) . Both groups received the same postoperative physical therapy . MAIN OUTCOME MEASURES Incidence of PPCs , especially pneumonia , and duration of postoperative hospitalization . RESULTS Both groups were comparable at baseline . After CABG surgery , PPCs were present in 25 ( 18.0 % ) of 139 patients in the IMT group and 48 ( 35.0 % ) of 137 patients in the usual care group ( odds ratio [ OR ] , 0.52 ; 95 % confidence interval [ CI ] , 0.30 - 0.92 ) . Pneumonia occurred in 9 ( 6.5 % ) of 139 patients in the IMT group and in 22 ( 16.1 % ) of 137 patients in the usual care group ( OR , 0.40 ; 95 % CI , 0.19 - 0.84 ) . Median duration of postoperative hospitalization was 7 days ( range , 5 - 41 days ) in the IMT group vs 8 days ( range , 6 - 70 days ) in the usual care group by Mann-Whitney U statistic ( z = -2.42 ; P = .02 ) . CONCLUSION Preoperative IMT reduced the incidence of PPCs and duration of postoperative hospitalization in patients at high risk of developing a pulmonary complication undergoing CABG surgery . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N17691887",
"This study evaluated the efficacy of the relaxation response on the post-operative recovery of 27 cardiac surgery patients r and omly assigned to one of two groups . Thirteen experimental group patients received educational information and practice d eliciting the relaxation response before and after surgery . The 14 patients in the control group received only information . Experimental and control groups were compared before and after surgery on both physiological and psychological recovery variables . There were no initial differences between experimental and control groups on demographic , physiological , and most psychological variables . The experimental group had lower incidence of postoperative supraventricular tachycardia ( SVT ) than the control group ( p = .04 ) despite having had the same occurrence previously . Experimental and control groups did not significantly differ over the course of study on any other physiological variables . Patients practicing the relaxation response had greater decreases in psychological tension ( p = .04 ) and anger ( p = .04 ) than those who received only educational information . The decreases in psychological tension may have been a result of regression to the mean because the experimental group started with elevated tension relative to the control group ( p = .04 ) . We conclude that practicing the relaxation response before and after surgery may reduce SVT , tension , and anger",
"BACKGROUND Postoperative pneumonia ( PP ) is a major complication that has been linked to microaspiration of pathogens originating in the gastrointestinal tract . This prospect i ve study was performed to define the role of gastric bacterial aspiration in the development of PP . METHODS Informed consent was obtained before operations from 140 veterans scheduled for major elective procedures requiring nasogastric tubes , and cultures were obtained of the gastric contents and sputum twice daily after operation . RESULTS PP developed in 26 ( 18.6 % ) of 140 patients . The patients who had PP did not differ from those with no pneumonia after operation except for a history of chronic obstructive pulmonary disease , which was found in 38.5 % of those with PP compared with 20 % of patients with no pneumonia ( p Morbidity was increased in association with PP , because length of stay in the surgical intensive care unit ( 6.2 vs 2.6 days ) , days intubated ( 2.7 vs 0.6 ) , total postoperative days ( 15.3 vs 8.4 ) , and mortality rates ( 19.2 % vs 1.7 % ) were greater than in patients with no pneumonia . Gastric pathogens were present on entry in 38 % of patients , and 32 % of these had PP compared with 13 % whose initial gastric cultures were sterile ( p = 0.01 ) . Colonization of sputum for greater than 24 hours with gastric pathogens occurred in 28 % of patients . These patients had a 40 % incidence of PP compared with 12 % in patients without such evidence of microaspiration ( p < 0.01 ) . CONCLUSIONS PP is a morbid postoperative complication associated with not only chronic obstructive pulmonary disease but also the presence of gastric bacteria during operation and transmission of gastric bacteria to the pulmonary tree after operation",
"In Ontario , Canada , the discrepancy between the high dem and for coronary artery bypass graft surgery ( CABG ) and the low immediate supply results in waiting lists . In 1990 , a consensus panel of cardiologists and surgeons developed criteria to ensure that high-risk patients were given priority for this procedure ( 1 ) . Each patient receives an acuity score that corresponds to a recommended maximum delay . Aggregated acuity scores of 4 , 5 , 6 , and 7 indicate elective status and represent a waiting time ranging from greater than 14 days to a maximum of 6 months . The mortality rate for patients awaiting CABG has been shown to be remarkably stableapproximately 0.5 % to 0.6 % per year over the past 10 years ( 2 ) . Despite this , however , evidence shows that patients ' functional and psychological status can deteriorate during the wait for surgery ( 3 - 5 ) . Through its effects on the autonomic nervous system , emotional stress also influences catecholamines , myocardial oxygen dem and , and platelet aggregation ; this may affect morbidity during the waiting period ( 6 - 8 ) . Such factors as preoperative anxiety and little social support have adverse psychological effects during extended preoperative waiting periods and , in addition , have been found to predict poor physical recovery from heart surgery ( 9 ) . Therefore , psychological factors and physical deconditioning , both of which occur during the waiting period ( 10 - 12 ) , may negatively affect patients ' in-hospital course , including length of stay . Because waiting for health services will probably continue to be a reality in publicly funded health care systems that value universal access , careful study of simple , affordable methods to improve patient outcomes during the waiting period is warranted . We examined the effect of a minimum 8-week , multidimensional , preoperative intervention on the presurgery and postsurgery outcomes of patients awaiting elective CABG . We hypothesized that a combination of exercise training , education , and social support would affect patients ' physical and psychological readiness for surgery and thereby reduce postoperative length of hospital stay . We further hypothesized that the effectiveness of the preoperative intervention would be sustained into the first 6 months of the postoperative period . Methods Patients Patients were recruited from the waiting lists of all seven cardiovascular surgeons operating in the Hamilton Health Sciences Corporation surgical center , Hamilton , Ontario , Canada . Each year , approximately 1300 open-heart surgeries are performed in this center . Roughly 60 % of patients awaiting CABG have elective status and are placed on the waiting list . During the time of our study , elective waiting times ranged from 3 weeks to greater than 20 weeks . Approximately 40 % of elective patients are usually awaiting first-time CABG ( nonvalve replacement ) . Only patients awaiting a first CABG whose surgery date s were at least 10 weeks away were approached to participate in our study . Patients were excluded if they were having combined CABG and valve surgery , if their ejection fractions were less than 0.40 , if they could not attend the exercise classes because of geographic inaccessibility , or if they were unable to participate because of physical limitations . After these inclusion and exclusion criteria were applied , our pool of potential participants was approximately 250 patients per year . We intended to select low-risk patients because it is not common to test an exercise intervention in patients awaiting CABG . Design We design ed a two-group r and omized , controlled trial . Eligible patients were r and omly assigned to 8 weeks of multidimensional preoperative intervention or to usual care . Those assigned to usual care were followed by their primary care physicians , cardiologists , or surgeons . During the waiting period , the intervention group received individualized , prescribed exercise training twice per week in a supervised environment ; education and reinforcement ; and monthly nurse-initiated telephone calls to answer questions and provide reassurance . After surgery , patients in both the treatment and control groups were given the opportunity to join the existing cardiac rehabilitation program ( Appendix ) . Outcomes The primary outcome was postoperative length of hospital stay . Secondary outcomes were peak exercise performance , health-related quality of life , social support , anxiety , and utilization of health care services . Measurements were taken at baseline , 1 week before surgery , 6 to 8 weeks after surgery , and 6 months after surgery . All of the secondary outcome variables were measured at baseline and 1 week before surgery . At 6 weeks and 6 months after surgery , only exercise performance , quality of life , and social support were measured . Determination of Sample Size Sample size was determined by using 19941995 data on length of stay in our surgical center . According to a r and om sample of 20 patients undergoing elective CABG , the mean total length of stay SD was 9.4 3.5 days . On the basis of these data , and accounting for a loss of 10 % to 15 % of patients , we determined that a sample size of 125 patients per group had sufficient power ( 0.8 ) to detect a 1-day reduction in hospital stay ( = 0.05 ) . Procedures The Research Ethics Board of McMaster University ( Hamilton , Ontario ) and the study hospital approved the study . On a weekly basis , staff at each of the surgeon 's offices supplied the names of patients who were scheduled to wait at least 10 weeks for surgery . Patients were telephoned , and the study was explained to them . The recruitment officer was completely c and i d about the r and om assignment and the treatments that would be offered to each group . Within 1 week after giving verbal consent , patients came to the clinic to provide written informed consent . At this visit , we collected complete baseline data and patients underwent an exercise test . Baseline data included demographic information ( age , sex , socioeconomic status , living arrangements , education , and employment status ) ; medical history ; past and present smoking status ; and history of myocardial infa rct ion , angina , congestive heart failure , and diabetes . Baseline data were also collected on anxiety , health-related quality of life , utilization of health care services , and social support . Data later obtained from medical records included total length of hospital stay , length of postoperative stay , number of hours spent in the intensive care unit ( ICU ) before receiving a discharge order , and actual hours spent in the ICU . R and omization and Blinding The study coordinator r and omly assigned patients to study groups by using a concealed r and omization process . A consultant prepared the r and omization schedule , and assignments were sealed in opaque envelopes that were opened in sequence after consent and baseline data were obtained . Patients were not blinded to their group assignments . However , the patients ' physicians ( cardiologists , surgeons , and general practitioners ) were blinded to group assignment and were not informed of it at any point in the study by patients or health care staff . Persons involved in offering the intervention ( nurses , kinesiologists , dietitians ) were aware of the patients ' group assignments but had no role in determining the patients ' readiness for discharge from the ICU or from the hospital ; therefore , they did not directly affect the primary outcome . Assessment of Outcomes Data on length of stay were collected by individual chart review . Total length of stay and total length of ICU stay were easily determined by using admission and discharge date s. However , after discussion with the cardiovascular surgeons before the study began , we realized that total length of ICU stay would misrepresent patients ' postoperative progress . On many occasions , the patient is ready for discharge from the ICU but bed or staffing issues substantially delay his or her actual departure . Therefore , we collected data on length of ICU stay in hours and , more particularly , in hours until order for ICU discharge . This required detailed chart review to locate time in and time out information as well as the time that the physician 's discharge order was given . Although the physicians often did not record the times of their orders , these data were found in nurses ' ICU notes . In approximately 5 % of cases , the data were not retrievable and the mean time until order for discharge was imputed . Exercise performance was measured by using a symptom-limited , upright-cycle ergometer exercise test . General health-related quality of life was measured by using the Medical Outcomes Study 36-item Short Form Survey ( SF-36 ) ( 13 ) . Social support was measured by using the Interpersonal Support Evaluation List ( 14 ) , and the total scale score was used in analysis . Anxiety was measured with the Spielberger StateTrait Anxiety Inventory ( 15 ) , from which both a trait score and a state anxiety score were computed . The total score from the Health Services Utilization Question naire ( 16 ) was computed and used in the analysis ( Appendix ) . Statistical Analysis All analyses were performed by using the SPSS statistical package ( 17 ) , versions 6.0 and 8.0 ( SPSS , Inc. , Chicago , Illinois ) . We analyzed data on patients whose status was elective from study entry until 1 week before surgery ( n = 220 ) . Data were complete for the primary outcome variables . When a measurement tool did not supply an approach for dealing with missing data , we used an imputation strategy , the hot deck approach ( 18 ) , in which the score from a matched patient in the same group is substituted for the missing score . The defining characteristics for matching patients were age , sex , and number of bypasses required . At the measurement point 6 months after surgery , 78 % of patients returned for all final assessment s. Follow-up to establish vital status was complete for all patients . Data on length of stay are usually positively skewed . Therefore , we selected the MannWhitney test for",
"Objective An investigation into the incidence of post-operative complications after thoracic surgery with 3 different physiotherapy masks . Design A prospect i ve , consecutive , r and omized comparison . Setting Department of Thoracic and Heart Surgery at a University Hospital . The treatments were performed by experienced and specially trained physiotherapists . Patients 160 patients were evaluated . 60 patients undergoing heart surgery , 59 patients having pulmonary resection , and 41 patients with exploratory thoractomy . Interventions In each operative category the patients were treated with one of three face mask systems used in addition to routine chest physiotherapy . These were either continuous positive airway pressure ( CPAP ) , positive expiratory pressure ( PEP ) , or inspiratory resistance — positive expiratory pressure ( IR-PEP ) . Measurements and results Post-operative pulmonary complications were assessed by forced vital capacity ( FVC ) , arterial oxygen tension ( PaO2 ) , and chest X-ray examination , all measured pre-operatively and on the fourth and ninth post-operative day . The patients filled in a question naire expressing their opinion about their mask treatment . There was an equal decrease in FVC , FVC% , and PaO2 , and equal frequency of atelectasis in the 3 mask treatments . More patients with the PEP mask favoured their system than did those with the other 2 systems . Conclusion There was no statistically significant difference between the treatments : continuous positive airway pressure ( CPAP ) , positive expiratory pressure ( PEP ) , and inspiratory resistance — positive expiratory pressure ( IR-PEP ) on post-operative complications . Any of the three treatments may be used as supplement to st and ard chest physiotherapy",
"Abstract Objective . To investigate the efficiency of inspiratory muscle training ( IMT ) on postoperative respiratory muscle strength , functional capacity , quality of life , and psychosocial status in patients with coronary artery bypass graft ( CABG ) surgery . Design . Forty-three patients undergoing CABG surgery were r and omly assigned to the one of two groups . All subjects received usual care . In addition , subjects in the intervention group received IMT training pre- and postoperatively . Pulmonary function testing , six minute walk test ( 6MWT ) , quality of life and psychosocial parameters were assessed preoperatively and the fifth day after the surgery . Results . The mean inspiratory muscle strength increased from 82.64 cmH2O at baseline to 95.45 cmH2O five days postoperatively in the intervention group . The intervention group ( 319.55 ± 72.17 m before and 387.91 ± 65.69 m after surgery ) covered further distance during the 6MWT than usual care ( 355.43 ± 56.08 m before and 357.69 ± 43.42 m after surgery ) . The improvement in quality of life was greater in the intervention group for the dimension of sleep . The anxiety scores were significantly lower in the intervention group than the usual care group . The length of intensive care unit stay was significantly shorter in the intervention group than the usual care group ( p Conclusion . IMT results in faster recovery of inspiratory muscle strength , functional capacity , intensive care unit stay , quality of life and psychosocial status after CABG",
"This is a prospect i ve study of 500 consecutive patients having coronary artery bypass surgery ; mean hospital charge from time of surgery to discharge was + 11,900 + /- 12,700 . Multiple regression analysis was performed using preoperative variables and postoperative complications . No preoperative clinical feature was a significant predictor of higher average charge . Sternal wound infection ( p = 0.0001 ) , respiratory failure ( p = 0.0001 ) and left ventricular failure ( p = 0.017 ) were associated with higher average hospital charge . The absence of any complication predicted a lower average charge , and postoperative death ( 4.4 + /- 4.5 days after surgery ) was also associated with lower average charge . A cost equation was developed : hospital charge equalled $ 11,217 + $ 41,559 of sternal wound infection , + $ 28,756 for respiratory failure , + $ 5,186 for left ventricular failure , - $ 1,798 for no complication and - $ 6,019 for death . Recognition of the influence of complications on charges suggests that low average charges can only be achieved by surgical programs with a low complication rate",
"AIM A variety of chest radiograph abnormalities are recognized after coronary artery bypass grafting ( CABG ) . This study analyzes the appearance of preoperative and postoperative chest radiographs in two groups of patients undergoing myocardial revascularization with or without the use of cardiopulmonary bypass ( CPB ) . METHODS Chest radiographs ( preoperative and at 1 day , 6 days and 6 to 8 weeks post operatively ) were analyzed according to a detailed protocol in cases of conventional CABG on CPB ( n=60 ) or off-pump coronary artery bypass ( OPCAB ) ( n=60 ) surgery . On each film 17 different major potential postoperative abnormalities were analyzed . RESULTS Clinical findings were similar in the two groups . Patients undergoing OPCAB surgery had decreased blood loss , decreased red cell and platelet transfusion , significantly lower intubation time and required less postoperative inotropic support compared with patients undergoing CPB . The CPB group had a significantly higher incidence of left b and atelectasis than the OPCAB group ( 37.6 % vs 17.5 % , p=0.01 ) at 6 days postoperatively . There was no other statistically significant difference in any of the 16 remaining major chest radiograph findings between the two groups . CONCLUSION Although OPCAB surgery is associated with improved clinical outcome compared with conventional CABG surgery , the analysis of postoperative chest radiographs demonstrated only a minor benefit as shown by a reduced degree of left b and atelectasis in the OPCAB group",
" Two hundred patients who had suffered an acute myocardial infa rct ion 4 - 6 weeks before entered a r and omised controlled trial of exercise treatment at a community sports centre supervised by a general practitioner . Eighty one per cent of the treatment group continued to exercise until they returned to work and 73 % completed three months ' exercise . There were no serious complications of the exercise course . The prevalence of angina pectoris fell by 10 % in the treatment group but rose by 60 % in the control group . The perceived energy level rose by significantly more in the treatment group than in the controls . The rise in predicted maximum oxygen uptake was significantly greater in the treatment group than in the control group as was the reduction in the double product ( a reflection of myocardial workload ) at peak exercise . Coronary rehabilitation in the community can be both safe and effective",
"Pulmonary complications after cardiac surgery are a leading cause of postoperative morbidity and mortality . Respiratory muscle weakness may contribute to the postoperative pulmonary abnormalities . We hypothesized that : inspiratory muscle strength ( PImax at RV ) and endurance ( PmPeak/PImax ) decrease following coronary artery bypass grafting ( CABG ) ; that this weakness is associated with impaired pulmonary function tests ( PFT ) , impaired gas exchange and a higher rate of pulmonary complications ; and that prophylactic inspiratory muscle training ( PIMT ) will prevent these changes . 30 c and i date s for CABG , ranging in age from 33 to 79 , were evaluated and r and omized into 2 groups : 15 received PIMT using a threshold trainer for 30 min/day for 1 month before operation , while 15 served as controls and received sham training . There was a significant decrease in respiratory muscle function , PFT , and gas exchange in the control group following CABG , while in the trained group these parameters where similar to those before entering the study . The differences between the groups were statistically significant . In addition , 4 ( 27 % ) in the control group , but only 1 ( 7 % ) in the trained group had postoperative pulmonary complications . We conclude that CABG is followed by significant deterioration in inspiratory muscle function , PFT and arterial blood gases . Decrease in these parameters can be prevented by PIMT , which may also prevent postoperative pulmonary complications",
"Preoperative cardiac surgical teaching done on a preadmission vs postadmission basis did not affect subjects ' perception of importance of preoperative information or preparation . Hospital teaching methods must be examined so that patient learning is individualized and available when the patient is ready to learn . Preoperative teaching on a preadmission basis may also facilitate admission of the cardiac surgical patient the day of surgery , which could shorten the length of stay",
"Background Sometimes a high intrapulmonary shunt occurs after cardiac surgery , and impairment of lung function and oxygenation can persist for 1 week after operation . Animal studies have shown that postoperative shunt can be explained by atelectasis . In this study the authors tried to determine if atelectasis can explain shunt in patients who have had cardiac surgery . Methods Nine patients having coronary artery bypass graft surgery and nine patients having mitral valve surgery were examined using the multiple inert gas elimination technique before and after operation . On the first postoperative day , computed tomography scans were made at three levels of the thorax . Results Before anesthesia , the average shunt was low ( 2 + /‐ 3 % ; range , 0–13 % ) , but on the first postoperative day shunt had increased to 12 + /‐ 6 % ( range , 3–28 % ) . The computed tomography scans showed bilateral dependent densities in all patients but one . The mean area of the densities was 8 + /‐ 8 % ( range , 0–37 % ) of total lung area , corresponding to a calculated fraction of collapsed lung tissue of 20 + /‐ 14 % ( range , 0–59 % ) . In the basal region , the calculated amount of collapsed tissue was 28 + /‐ 19 % ( range , 0–73 % ) . One mitral valve patient was an outlier and had a large shunt both before and after the operation . Conclusions Large atelectasis in the dorsal part of the lungs was found on the first postoperative day after cardiac surgery . However , there was no clear correlation between atelectasis and measured shunt fraction",
"Background In rats , low-frequency electroneuro-stimulation ( ENS ) of the ear afferent vagus endings and bramstem structures via transauricular electro-acupuncture increases the parasympathetic tone of the autonomic nervous system . We examined the effects of ENS applied in the preoperative period in patients with coronary artery disease ( CAD ) who underwent coronary artery bypass grafting operations Methods ENS was performed in a group of 10 patients with CAD who were classified as Canadian Cardiovascular Society class IV before operation . A second group of 10 patients with a similar degree of CAD compnsed a control group . The efficacy of the procedure was evaluated on the basis of improvement in the patient 's clinical course before and after operation . The presence of major inducible stress protein ( HSP 70i ) and the ATP content of the myocardium was determined in atrial tissue ( part of the right heart auricle ) from both groups of patients . Tissue from patients with Wolff-Parkinson-White ( WPW ) syndrome served as a control , non-ischemic , cardiac tissue . Results A course of 10 ENS procedures improved the patients ' preoperative clinical course , producing a rapid reduction in their angina . By the end of the course , the patients no longer developed angina either at rest or after a moderate physical load , and their dependence on treatment with vasodilators had decreased considerably . Atnal tissue from patients with CAD who were treated with ENS was similar to that from patients with WPW in leaking HSP 70i and in ATP content . In contrast , tissue from the control group of patients with CAD contained HSP 70i and had an increased content of ATP . The antianginal effect of neurostimulation lasted for at least 2–3 weeks after completion of the procedures . The postoperative recovery of patients treated with ENS was characterized by stable hemodynamics and sinus rhythm . Conclusion We conclude that ENS had a central vagotonic/sympatholytic influence on the heart , leading to the development of three main effects in patients with CAD : relief of anginal symptoms , diminution of some biochemical myocardial signs of the disease , and an increase in the heart 's tolerance of operative reperfusion damage"
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ABSTRACT Anemia is a worldwide public health problem that can be related to many causes , including vitamin A deficiency . The aim of this study was to assess and estimate the effect of vitamin A supplementation ( VAS ) on iron status biomarkers and anemia in humans . Six data bases , including Cochrane , EMBASE , LILACS , Pubmed , Scopus and Web of Science , were search ed for clinical trials and cohort studies that investigated the effect of vitamin A supplementation alone on iron status and anemia , without time-restriction . The search yielded 23 eligible studies , 21 clinical trials and 2 cohort studies , with children , teenagers , pregnant or lactating women . The meta- analysis of the clinical trials showed that VAS reduces the risk of anemia by 26 % and raises hemoglobin levels , compared to non-treated group , independent of the life stage . VAS did not alter the prevalence of iron deficiency among the clinical trials conducted with children and teenagers ( RR 0.82 , 95 % CI 0.60 to 1.12 , p = 0.204 ) , whereas a significant increase in serum ferritin levels was observed in trials conducted with pregnant and lactating women ( WMD 6.61 μg/L ; 95 % CI 6.00 to 7.21 μg/L ; p Therefore , vitamin A supplementation alone may reduce the risk of anemia , by improving hemoglobin and ferritin levels in individuals with low serum retinol levels
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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",
"We conducted a r and omized controlled trial of the effects of dietary supplements on anemia , weight and height in 136 anemic school children from a low socioeconomic background in Bagamoyo District schools in Tanzania . The aim of the current study was to investigate the impact of dietary supplements on anemia and anthropometric indices of anemic school children . The supplements were vitamin A alone , iron and vitamin A , iron alone or placebo , administered in a double-blinded design for 3 mo . All supplements were provided with local corn meals . Hemoglobin concentration , body weight and height were measured at baseline and at follow-up after supplementation . Vitamin A supplementation increased the mean hemoglobin concentration by 13.5 g/L compared with 3.5 g/L for placebo [ P mean body weight by 0.6 kg compared with 0.2 kg for placebo ( P mean height by 0.4 cm compared with 0.1 cm for placebo ( P = 0.0009 , 95 % CI 0.08 - 0.42 ) . However , the group of children who received combined vitamin A and iron supplementation had the greatest improvements in all indicators compared with placebo ( 18.5 g/L , P hemoglobin , weight and height , respectively ) . It is likely that vitamin A supplementation may have a useful role in combating the problems of vitamin A deficiency and anemia , as well as in improving children 's growth , in developing countries",
"In Indonesia , deficiencies of vitamin A and iron are of public health concern during pregnancy . We sought to determine the effects of vitamin A and iron supplementation on the vitamin A and iron status of pregnant Indonesian women . The women ( n = 27 ) were r and omly assigned to four groups . The modified relative dose response ( MRDR ) test for vitamin A status and hemoglobin , hematocrit and ferritin values were determined at baseline . Thereafter , daily supplements were administered : placebo [ Pl ] ( n = 7 ) , 8.4 micromol vitamin A [ A ] ( n = 7 ) , 1.07 mmol iron [ Fe ] ( n = 5 ) , and 8.4 micromol vitamin A plus 1.07 mmol iron [ A + Fe ] ( n = 8) . Post-treatment tests were performed after 8 wk . The MRDR value was reduced , i.e. , vitamin A status improved , more markedly by the combination of vitamin A and iron than by either nutrient alone ( P = 0.034 ) . The decrease in the MRDR relative to baseline was significant in the A + Fe group ( P = 0.008 ) . Iron status was also significantly improved in these women ( P iron and vitamin A supplementation . The mechanism of the enhancing effect of iron on the vitamin A-induced reduction in the MRDR is not known",
"BACKGROUND Iron deficiency is the most common micronutrient deficiency and affects > 2 billion persons worldwide , leading to anemia in > 40 % of women of reproductive age in the developing world . OBJECTIVE The objective was to determine whether weekly supplementation with iron and folate would reduce the frequency of anemia in teenage women in urban Bangladesh before they became pregnant . DESIGN Participants with a hemoglobin concentration of 80 - 120 g/L were entered into a r and omized , double-blind , placebo-controlled trial and received supplements of placebo , vitamin A , iron + folic acid , or iron + folic acid + vitamin A weekly for 12 wk . The supplements contained 2.42 mg vitamin A ( retinol ) as retinyl palmitate , 120 mg elemental Fe as ferrous sulfate , and 3.5 mg folic acid . RESULTS Hemoglobin concentrations increased significantly more after supplementation with iron + folic acid or iron + folic acid + vitamin A than after either the placebo or vitamin A alone . There was a significantly greater increase in hemoglobin after iron + folic acid + vitamin A than after iron + folic acid , but the additional effect disappeared after adjustment for baseline hemoglobin , serum vitamin A , and ferritin and the number of supplements taken . Those with the lowest baseline hemoglobin had the greatest increase in hemoglobin . Compared with the placebo , iron + folic acid + vitamin A reduced anemia by 92 % , iron deficiency by 90 % , and vitamin A deficiency by 76 % . CONCLUSION There may be significant health benefits from a program that enhances the nutritional status of iron , folate , and vitamin A in poor urban young women before they become pregnant",
"BACKGROUND The pathophysiology of anemia in coastal East Africa is complex . Impaired erythropoietin production is one possible mechanism . Plasmodium falciparum malaria has been found to blunt erythropoietin production , whereas vitamin A stimulates erythropoietin production in vitro . OBJECTIVE We investigated the 72-h effects of vitamin A and the antimalarial drug sulfadoxine pyramethamine ( SP ) on erythropoietin production in severely anemic ( hemoglobin We hypothesized that both treatments would stimulate erythropoietin production directly , within 72 h , before a change in hemoglobin would occur . DESIGN One hundred forty-one severely anemic children were identified during the baseline assessment of a morbidity sub study of a community-based micronutrient supplementation trial . All severely anemic children were r and omly assigned to receive either vitamin A ( 100,000 or 200,000 IU depending on age ) or SP at baseline ; 72 h later they received the opposite treatment plus daily hematinic syrup for 90 d. Erythropoietic and parasitic indicators were assessed at baseline and again after 72 h. RESULTS After 72 h , SP reduced the malaria parasite density ( by 5029 parasites/microL ; P CRP concentrations ( by 10.6 mg/L ; P = 0.001 ) , and the proportion of children infected with malaria ( by 32.4 % ; P Vitamin A reduced CRP ( by 9.6 mg/L ; P = 0.011 ) , serum ferritin ( by 18.1 microg/L ; P = 0.042 ) , and erythropoietin ( by 194.7 mIU/mL ; P = 0.011 ) concentrations and increased the reticulocyte production index ( by 0.40 ; P = 0.041 ) . CONCLUSIONS Contrary to our hypothesis , vitamin A significantly decreased erythropoietin concentration . The most important effect of both vitamin A and SP was the rapid reduction of inflammation . Vitamin A also mobilized iron from stores and stimulated the production of new erythrocytes",
"Ninety-nine anemic children aged 1 - 8 y were divided into four groups . Each group was supplemented for 2 mo with vitamin A , iron , vitamin A plus Fe , or a placebo . Clinical , hematological , and Fe biochemical evaluations were performed at the beginning and end of the study . Vitamin A supplementation produced significant elevations in the serum levels of retinol , blood hemoglobin , hematocrit , erythrocytes , serum Fe , and percent transferrin saturation ( % TS ) and had no effect on total Fe binding capacity ( TIBC ) or serum ferritin . Fe supplementation did not affect serum retinol . However , it improved hematological and Fe nutrition indicators , including TIBC and serum ferritin . The simultaneous administration of vitamin A and Fe result ed in a better response of serum Fe and % TS than when the supplement consisted only of vitamin A or Fe alone . Vitamin A benefits hematological condition and Fe metabolism",
"BACKGROUND Anemia is prevalent in infants in developing countries . Its etiology is multifactorial and includes vitamin A deficiency . OBJECTIVE Our primary aim was to measure the effect of maternal or neonatal vitamin A supplementation ( or both ) on hemoglobin and anemia in Zimbabwean infants . Our secondary aim was to identify the underlying causes of postnatal anemia . DESIGN A r and omized , placebo-controlled trial was conducted in 14 110 mothers and their infants ; 2854 infants were r and omly selected for the anemia sub study , of whom 1592 were successfully observed for 8 - 14 mo and formed the study sample . Infants were r and omly assigned within 96 h of delivery to 1 of 4 treatment groups : mothers and infants received vitamin A ; mothers received vitamin A and infants received placebo ; mothers received placebo and infants received vitamin A ; and mothers and infants received placebo . The vitamin A doses were 400,000 and 50,000 IU in the mothers and infants , respectively . RESULTS Vitamin A supplementation had no effect on hemoglobin or anemia ( hemoglobin anemia risk > 6-fold . Additional predictors of anemia in HIV-negative and -positive infants were male sex and lower total body iron at birth . In addition , in HIV-positive infants , the risk of anemia increased with early infection , low maternal CD4 + lymphocyte count at recruitment , and frequent morbidity . Six-month plasma ferritin concentrations < 12 microg/L were a risk factor in HIV-negative but not in HIV-positive infants . Maternal HIV infection alone did not cause anemia . CONCLUSION Prevention of infantile anemia should include efforts to increase the birth endowment of iron and prevent HIV infection",
"OBJECTIVE Evidence from animal experiments and observational studies in humans suggests that vitamin A plays a fundamental role in physical growth . However , results from vitamin A supplementation trials in children are inconsistent ; whereas some did not find an overall effect on growth , others found benefits only among specific groups , including children with low concentrations of serum retinol or short duration of breastfeeding . The apparent lack of an overall effect of vitamin A on growth could be attributed to context -specific distribution of conditions that affect both growth and the response to supplementation , eg , baseline vitamin A status , deficiency of other nutrients ( fat , zinc ) , and the presence of infectious diseases . Human immunodeficiency virus ( HIV ) infection , malaria , and diarrheal disease adversely affect growth and are associated with increased prevalence of vitamin A deficiency . We hypothesize that vitamin A supplementation could ameliorate the adverse effect of these infections on child growth . METHODS We conducted a r and omized , clinical trial among 687 Tanzanian children who were 6 to 60 months of age and admitted to the hospital with pneumonia . Children were assigned to oral doses of 200 000 IU vitamin A ( half that dose if or placebo on the day of admission , a second dose on the following day , and third and fourth doses at 4 and 8 months after discharge from the hospital , respectively . Anthropometric measurements were obtained at baseline and at monthly visits to the study clinics during 12 months after the initial hospitalization . Surveillance on the incidence and severity of diarrhea and respiratory infections was conducted during biweekly visits , alternately at a study clinic and the child 's home , using a pictorial diary that the mothers were trained to use . A blood specimen was drawn at baseline for determination of HIV status , malaria infection , and hemoglobin levels . We used mixed effects models to compare estimated total weight and height increases after 1 year of follow-up between treatment arms , overall and within levels of HIV status , malaria , and other possible baseline effect modifiers . We also assessed the potential modulating effect of vitamin A on the risk of stunting ( height-for-age relative risks and 95 % confidence intervals ( CI ) , treating episodes of infection as time-dependent covariates . RESULTS A total of 554 children had at least 2 follow-up measurements of height or weight and constituted the study base . Baseline characteristics did not differ significantly by treatment arm . Seventy-three percent of the children were % were 31 % were stunted at baseline and 9 % were wasted . Malaria ( Plasmodium falciparum ) and HIV infection were found in 24 % and 9 % of the children , respectively . Median duration of follow-up was 351 days , with 10 measurements /child , on average , irrespectively of treatment assignment . Supplementation with vitamin A among children who had HIV infection and were result ed in a significant length increase . Four months after the first dose , infants who were HIV positive in the vitamin A arm had gained , on average , 2.8 cm ( 95 % CI : 1.0 - 4.6 ) more than children who received placebo , whereas no effect was observed among infants who were HIV negative ( difference at 4 months : -0.2 cm ; 95 % CI : -0.8 - 0.5 ) . Children who were at enrollment experienced a 747-g ( 95 % CI : 71 - 1423 ) higher yearly weight gain attributable to vitamin A ; among children without malaria , however , the supplements did not have a significant effect ( -57 g ; 95 % CI : -461 - 348 ) . These results remained unchanged after controlling for indicators of the socioeconomic and nutritional status at baseline . Linear growth was also improved by vitamin A among children from households with poor water supply ( 0.8 cm/year ; 95 % CI : 0 - 1.5 ) but not in children with tap water in the house or compound ( -1.0 cm/year ; 95 % CI : -1.9 - 0 ) . Weight gain was greater among children with mid-upper arm circumference below the 25th percentile of the age-specific distribution at baseline ( 458 g/year ; 95 % CI : 1 - 905 ) , but no benefit was evident among children with higher mid-upper arm circumference . The risk of stunting associated with episodes of persistent diarrhea ( lasting 14 or more days ) during follow-up was virtually eliminated by vitamin A supplements . Among children in the placebo group , the average risk of stunting associated with 1 or more episodes of persistent diarrhea between 2 consecutive visits was 5.2 times higher ( 95 % CI : 2.4 - 11.2 ) than that of children without diarrhea or with acute episodes . In contrast , among children who received vitamin A , there was virtually no risk of stunting associated with persistent diarrhea ( relative risk : 1.0 ; 95 % CI : 0.3 - 1.3 ) . This effect was slightly attenuated after controlling for the number of household possessions , gender , baseline low arm circumference , HIV infection , and presence of malaria parasites in blood . Vitamin A supplements did not modify the associations between respiratory infections and the risk of stunting or wasting . CONCLUSIONS Vitamin A supplementation improves linear and ponderal growth in infants who are infected with HIV and malaria , respectively , and decreases the risk of stunting associated with persistent diarrhea . Supplementation could constitute a low-cost , effective intervention to decrease the burden of growth retardation in setting s where infectious diseases are highly prevalent",
"BACKGROUND Vitamin A deficiency impairs iron metabolism ; vitamin A supplementation of vitamin A-deficient population s may reduce anemia . The mechanism of these effects is unclear . In vitro and in animal models , vitamin A treatment increases the production of erythropoietin ( EPO ) , a stimulant of erythropoiesis . OBJECTIVE We measured the effect of vitamin A supplementation on hemoglobin , iron status , and circulating EPO concentrations in children with poor iron and vitamin A status . DESIGN In a double-blind , r and omized trial , Moroccan schoolchildren ( n = 81 ) were given either vitamin A ( 200,000 IU ) or placebo at baseline and at 5 mo . At baseline , 5 mo , and 10 mo , hemoglobin , indicators of iron and vitamin A status , and EPO were measured . RESULTS At baseline , 54 % of children were anemic ; 77 % had low vitamin A status . In the vitamin A group at 10 mo , serum retinol improved significantly compared with the control group ( P Vitamin A treatment increased mean hemoglobin by 7 g/L ( P anemia from 54 % to 38 % ( P Vitamin A treatment increased mean corpuscular volume ( P serum transferrin receptor ( P . Vitamin A decreased serum ferritin ( P overall body iron stores remained unchanged . In the vitamin A group at 10 mo , we observed an increase in EPO ( P slope of the regression line of log10(EPO ) on hemoglobin ( P children deficient in vitamin A and iron , vitamin A supplementation mobilizes iron from existing stores to support increased erythropoiesis , an effect likely mediated by increases in circulating EPO",
"Laboratory tests used in the diagnosis of iron status lack specificity in defining iron deficiency anaemia ( IDA ) and anaemia of inflammation ( AI ) . The serum transferrin receptor ( sTfR ) may provide more information in this regard . The iron status of 561 pre‐school children was determined and classified using the conventional measurements . The value of the concentration of sTfR , the ratio of sTfR ( µg/ml ) to LogSF ( µg/l ) ( TfR‐Index ) , and the Log of the ratio of sTfR ( µg/l ) to SF ( µg/l ) − ( LogTfR : Fer ratio ) , in the classification of the iron status were determined by comparing their distributions across the classification of iron status . Although there were significant differences in sTfR and TfR‐Index across the categories of iron status , there was considerable overlap . All subjects with iron deficiency had LogTfR : Fer ratio > 2·55 , whereas in all subjects classified as AI it was The LogTfR : Fer ratio was not able to exclude IDA in the presence of inflammation . However , in cases of combined IDA and AI the LogTfR : Fer ratio was 2·55 after resolution of the inflammation . This novel method of calculating the LogTfR : Fer ratio may provide a more precise classification of the iron status of children",
"Preschool children in developing countries are likely to have multiple , concurrent micronutrient deficiencies . This study was design ed to evaluate the effectiveness of different combinations of nutritional fortified diet to improve the blood levels of iron , vitamin A and other essential micronutrients in the preschool population of Banan District of Chongqing , China . From December 2005 to June 2006 , a total of 226 2 - 6 y old preschool children were recruited from three nurseries in the area , and they were r and omly assigned to three different fortified diet groups for 6 mo . Group I was fortified with vitamin A ; groups II and III were fortified with vitamin A plus iron and vitamin A plus iron , thiamine , riboflavin , folic acid , niacinamide , zinc and calcium , respectively . Subjects ' weight and height were measured for assessing the children 's growth and development . Blood sample s were taken at the beginning and the end of the 6-mo study period for measuring serum levels of micronutrients . Group III with the multiple micronutrient fortified diet was the most effective to improve the serum level of retinol from [ media ( P25 , P75 ) : 1.06 ( 0.89 , 1.32 ) ] micromol/L to 1.29 ( 1.04 , 1.39 ) micromol/L ( p retinol binding protein from 17.0 ( 12.6 , 25.6 ) mg/L to 31.6 ( 24.4 , 44.0 ) mg/L ( p mobilize the stored iron in the liver ( p hemoglobin levels were elevated from 117.0 ( 109.0 , 124.1 ) g/L , 114.0 ( 109.2 , 119.7 ) g/L and 115.0 ( 109.5 , 122.7 ) g/L to 125.7 ( 119.2 , 133.1 ) g/L , 126.5 ( 122.2 , 135.9 ) g/L and 125.1 ( 119.8 , 131.6 ) g/L over the 6 mo of intervention period , but there were no difference among the three groups ( p>0.05 ) . Nevertheless , unexpected results were obtained when comparing the effects on growth status among the different supplement groups . Our study has demonstrated that a multiple micronutrient fortified diet for 6 mo is more effective to improve the levels of hemoglobin , serum retinol , and RBP as well as to facilitate the mobilization of iron storage in preschool children",
"Iron deficiency anaemia ( IDA ) is the most common nutritional deficiency in the world including developed and developing countries . Despite intensive efforts to improve the quality of life of rural and aboriginal communities in Malaysia , anaemia and IDA are still major public health problems in these communities particularly among children . A r and omized , double-blind , placebo-controlled trial was conducted on 250 Orang Asli ( aboriginal ) schoolchildren in Malaysia to investigate the effects of a single high-dose of vitamin A supplementation ( 200,000 IU ) on iron status indices , anaemia and IDA status . The effect of the supplement was assessed after 3 months of receiving the supplements ; after a complete 3-day deworming course of 400 mg/day of albendazole tablets . The prevalence of anaemia was found to be high : 48.5 % ( 95 % CI = 42.3 , 54.8 ) . Moreover , 34 % ( 95 % CI = 28.3 , 40.2 ) of the children had IDA , which accounted for 70.1 % of the anaemic cases . The findings showed that the reduction in serum ferritin level and the increments in haemoglobin , serum iron and transferrin saturation were found to be significant among children allocated to the vitamin A group compared to those allocated to the placebo group ( p IDA by almost 22 % than prevalence at baseline was reported among children in the vitamin A group compared with only 2.3 % reduction among children in the placebo group . In conclusion , vitamin A supplementation showed a significant impact on iron status indices and IDA among Orang Asli children . Hence , providing vitamin A supplementation and imparting the knowledge related to nutritious food should be considered in the efforts to improve the nutritional and health status of these children as a part of efforts to improve the quality of life in rural and aboriginal communities",
"To assess the prevalence of vitamin A deficiency in anemic Pakistani children and investigate the hematologic response to vitamin A supplementation , 4 - 8 year old primary school children from the slum areas of Karachi were surveyed for anemia . Of 101 anemic children selected , 16 % had low level of vitamin A ( Serum Retinol level showed positive associated with serum iron , ferritin , hemoglobin , hematocrit and Mean cell hemoglobin concentration . A non-r and omized control trial was then carried out . Oral vitamin A capsules were given to 42 children and 53 children served as controls . After 6 weeks , there were significant differences between the two groups for Retinol , Retinol-Binding-Protein and Hematocrit . However , no significant difference could be found for Hemoglobin , RBC count , Mean Corpuscular Volume , Mean Corpuscular Hemoglobin , Mean Corpuscular Hemoglobin Concentration , Serum iron , ferritin or transferrin . A single vitamin A supplement improved the hematocrit in 6 weeks . Long-term studies are needed to find if the WHO recommended periodic massive doses of vitamin A besides improving the morbidity and mortality will also improve the overall picture of anemia in children",
"Background and objective In re source -poor setting s , micronutrient deficiencies such as vitamin A deficiency may co-exist with iron-deficiency . In this study we assessed the iron and vitamin A status of schoolchildren and the association between vitamin A and iron status . Methods A cross-sectional design using the baseline data of a dietary intervention trial conducted among r and omly selected 5–12 years old schoolchildren ( n = 224 ) from 2 rural schools in northern Ghana . Hemoglobin ( Hb ) , serum ferritin ( SF ) and serum transferrin receptor ( sTfR ) concentrations were used as measures of iron status . Retinol binding protein ( RBP ) was used as a measure of vitamin A status . Sub clinical inflammation ( SCI ) was measured using C-reactive protein ( CRP ) and α1-acid glycoprotein ( AGP ) concentrations . We examined the cross-sectional association between vitamin A and iron status biomarkers with multiple linear regressions . Results The proportions of schoolchildren with anemia ( WHO criteria ) , iron-deficiency ( ID , SF > 8.5mg/l ) and iron-deficiency anemia ( IDA , concurrent anemia and ID ) were 63.8 % , 68.3 % and 46.4 % respectively . Low or marginal vitamin A status ( 0.70 μmol/l ≤ RBP vitamin A deficiency ( VAD , RBP SCI as well as concurrent VAD and ID were 48.7 % and 25 % respectively . RBP was associated with Hb ( β = 7.2 , P = 0.05 ) but not SF ( β = 20.7 , P = 0.33 ) and sTfR concentration ( β = 12.0 , P = 0.63 ) . In the presence of SCI , RBP was not associated with hemoglobin status but a significant positive association was observed among children without SCI . Conclusions The study shows that RBP is significantly associated with Hb concentration but not with SF and sTfR. The observed relationship between RBP and Hb is only significant in the absence of SCI",
"BACKGROUND It is not known whether daily consumption of vitamin A-containing foods is efficacious for treating nightblindness . OBJECTIVE We assessed the effect of supplementation with vitamin A from food or synthetic sources on dark adaptation and plasma retinol concentrations in nightblind pregnant Nepali women . DESIGN Nightblind pregnant women were r and omly assigned to 1 of 6 treatment groups to receive 6 d/wk for 6 wk either 850 microg retinol equivalents/d as retinyl palmitate , vitamin A-fortified rice , goat liver , amaranth leaves , or carrots or 2000 microg retinol equivalents/d as retinyl palmitate . Dark adaptation was assessed weekly by using the pupillary threshold ( PT ) test ; plasma retinol concentrations were measured before and after the intervention . These outcomes were also assessed in a comparison group of nonnightblind pregnant women . RESULTS In the nightblind women , the mean PT improved significantly ( P Improvement in dark adaptation was greater in the liver group than in the vitamin A-fortified rice group ( P Plasma retinol concentrations increased significantly ( P plasma retinol response was greater in the higher-dose capsule and liver groups than in the vegetable groups and significantly greater in the liver group than in the vitamin A-fortified rice group ( both : P dark adaptation did not differ significantly between women who received vitamin A as liver , amaranth leaves , carrots , or retinyl palmitate",
"To investigate the effect of vitamin A and Zn supplementation on vitamin A status , haemoglobin level and defecation of children with persistent diarrhea , a total of 160 paediatric patients were r and omly assigned to one of four intervention groups : daily supplementation of 1,500 IU VA for 14 days ; daily Zn supplementation for 14 days ; daily supplementation with both VA and Zn for 14 days ; no supplementation . One hundred twenty-seven children with persistent diarrhea finished intervention ( 33 were lost to follow-up ) . Among the 127 children , 41 ( 32.28 % ) had anaemia , 104 ( 81.89 % ) had a VA deficiency and 38 ( 29.92 % ) had an iron insufficiency . Supplementation with VA or VA + Zn enhanced the serum VA levels and ameliorated anaemia . Supplementation with Zn and VA + Zn for 5 days significantly improved defecation , where the VA + Zn treatment result ed in superior outcomes . After 14 days of intervention , the total effectiveness rates were 93.94 % , 96.77 % and 96.67 % in the three groups , significantly greater than that of the non-supplementation group ( 72.73 % ) . These results indicate that single VA or concurrent VA + Zn supplementation can improve vitamin A status , haemoglobin level and defecation . However , concurrent VA + Zn supplementation is the optimal option and can shorten the duration of persistent diarrhea and markedly improve nutritional status . ( www . clinical trials.gov registration number : ChiCTR-IOR-14005498",
"The associations of hemoglobin , hematocrit , and packed cell volume with socioeconomic factors , malaria , human immunodeficiency virus ( HIV ) infection , and nutritional status were examined among 687 children admitted to hospital with pneumonia participating in a double blind , placebo-controlled trial of vitamin A supplementation . Children were r and omized to receive 2 doses of vitamin A ( 200,000 IU ) or placebo at baseline , and additional doses at 4 and 8 months after discharge from hospital . Hemoglobin levels were measured at enrollment and , on a subset of 161 children , during follow-up . At baseline , hemoglobin concentration was positively associated with the number of possessions in the household , maternal level of education and quality of water supply , and inversely related to malaria infection after controlling for potential confounding variables . Children infected with HIV experienced a significant fall in mean hemoglobin levels over time . The risk of developing severe anemia ( severe anemia than did children without the diagnosis ( 95 % CI = 1.3 , 13.5 ; P = 0.02 ) . Vitamin A supplements were associated with an overall nonsignificant reduction of 14 % in the risk of developing severe anemia ( adjusted prevalence ratio = 0.86 , 95 % CI = 0.37 , 1.99 ; P = 0.73 ) . We conclude that malaria , HIV infection , low socioeconomic status , and short duration of breastfeeding are strong and independent determinants of adverse hematologic profiles in this population",
"Background / Objectives : Iron deficiency anemia is a major public health problem in developing countries and may affect school performance and physical work capacity in nonpregnant adolescents , and may increase the risk of anemia during subsequent teenage pregnancies . We assessed the effect of weekly iron ( 120 mg elemental iron ) and vitamin A ( 25 000 IU ) supplementation on hemoglobin , iron status and malaria and nonmalaria morbidity in adolescent schoolgirls . Subjects/ Methods : A total of 279 schoolgirls aged 12–18 years from public primary schools in Kisumu , western Kenya . Double-blind r and omized placebo-controlled trial using a factorial design . Results : Five months of iron supplementation was associated with a 0.52 g dl−1 ( 0.21 , 0.82 ) greater increase in hemoglobin relative to iron placebo . The effect was only observed in girls with iron deficiency on enrollment ( 1.34 g dl−1 ( 0.79 , 1.88 ) ) , but not in iron-replete girls ( −0.20 g dl−1 ( −0.59 , 0.18 ) ) . Similar differences in treatment effect were seen between menstruating and nonmenstruating girls . The effect of iron was independent of vitamin A. The baseline prevalence of vitamin A deficiency was low ( 6.7 % ) and no sustained increase in hemoglobin was seen with weekly vitamin A ( −0.07 g dl−1 ( −0.38 , 0.25 ) ) . Incidence of malaria parasitemia was higher in the iron than iron-placebo groups ( Rate ratio 1.33 ( 0.94 , 1.88 ) ) . Conclusions : Weekly iron supplementation results in substantial increases in hemoglobin concentration in adolescent schoolgirls in western Kenya , which may outweigh possible risks caused by malaria , but only in iron-deficient or menstruating girls and not in iron-replete and nonmenstruating girls",
"To explore the effect of vitamin A supplements on iron metabolic homeostasis for preschoolers . This was a r and omized , placebo-controlled and blinded intervention trial with 3- to 6-y old preschoolers . A total of 445 subjects were r and omly divided into four groups : a vitamin A supplementation group ( group 1 , a single oral dose of vitamin A as retinol 200,000 IU ) , an iron supplement group ( group 2 , daily oral supplement with the elemental iron 1 - 2 mg/kg/d for 5 d a week , lasting for 6 mo ) a combined vitamin A and iron ( group 3 ) and administration of no vitamin A or iron as a placebo-control ( group 4 ) . A total of 387 ( 95 , 98 , 90 and 104 from groups 1 , 2 , 3 and 4 ) children completed the intervention . After intervention , serum retinol levels of children in group 1 and group 3 was markedly higher than those of children in groups 2 and 4 ( p serum ferritin level of children in group 1 significantly decreased after intervention ( p sTfR-SF index ( TFR-F ) and total body iron content ( BTIC ) showed the same change after intervention . In group 2 and group 3 , the levels of TRF-F index and BTIC had statistically increased to the same degree after intervention ( p vitamin A intervention on iron metabolic homeostasis was mainly manifested in storage and mobilization ; there was no direct effect on total body iron content or iron absorption in the intestine",
"Objective : High prevalences of vitamin A deficiency and anaemia among adolescents warrant interventions . This study evaluated the effectiveness of school-based supplementation to reduce anaemia and improve vitamin A status . Design : School-based , grade -r and omized , intervention . Subjects and setting : In all , 1757 girls and 1859 boys , aged 12–15 y , in 24 Junior High Schools . Interventions : Weekly supplementation for 14 weeks with 60 mg iron and 250 μg folate ( Fe group ; n=978 ) , 10 000 IU vitamin A ( VA group ; n=970 ) or both ( VAFe group ; n=1042 ) to subjects in 15 schools , compared to subjects in nine other schools not receiving supplements ( control ; n=626 ) . Results : The baseline anaemia prevalence ( Hb girls was 20 % ( prepubertal ) and 26 % ( pubertal ) , and in boys 24 % ( pre-pubertal ) and 11 % ( pubertal ) . Serum retinol concentrations were low ( did not increase haemoglobin concentrations . Serum retinol concentration of boys , but not girls , in the VA group increased ( 0.33 vs 0.07 μmol/l in controls ; P serum retinol concentration were lower baseline serum retinol concentration ( OR 0.02–0.03 ) with , for girls , nightblindness at baseline ( OR 5.88 ) , and for boys , not receiving vitamin A ( OR control : 1.00 ; VA : 0.37 ; Fe : 0.77 ; VAFe : 0.34 ) and maternal illiteracy ( OR mother never attended school 1.00 , mother received any formal education 0.17–0.33 ) . Conclusions : Supplementation with vitamin A increased serum retinol concentration of boys . Iron supplementation did not change Hb . This appeared to be due to poor compliance , and partly related to side effects . Sponsorship : This study was funded by USAID through the OMNI Project",
"OBJECTIVE To investigate the efficacy of biscuits fortified with different doses of vitamin A on improving vitamin A deficiency ( VAD ) , anaemia and physical growth of pre-school children . DESIGN A r and omised double-masked population -based field interventional trial with a positive control group . SETTING Banan district of Chongqing , China . SUBJECTS A total of 580 pre-school children aged 3 - 6 years were r and omly recruited into four groups . Children in groups I and II were given biscuits fortified with vitamin A at 30 % of the recommended daily intake ( RDA ) and 100 % of the RDA once a day for 9 and 3 months , respectively . Children in group III received biscuits containing 20,000 IU of vitamin A once a week for 3 months . Initially , the children in group IV received a 200,000 IU vitamin A capsule just once . At the beginning and end of the study , blood sample s were collected to measure Hb , serum retinol , retinol-binding protein and prealbumin , and weight and height were measured . RESULTS All the fortification types significantly decreased the prevalence of VAD and anaemia in each group ( P Z-scores of height-for-age , weight-for-age and weight-for-height in all groups increased markedly compared with baseline ( P vitamin A-fortified biscuits with daily 100 % RDA for 3 months has the same effect on the improvement of VAD , anaemia and physical growth as did the weekly 20,000 IU and single 200,000 IU administration in pre-school children",
"The aim of this study was to explore the effect of single-dose albendazole and vitamin A intervention on the anaemic status and Fe metabolism of pre-school children . This study was a r and omised , placebo-controlled and double-blinded intervention trial . All eligible anaemic pre-school children were r and omly divided into three groups : group 1 received no intervention , which served as the control group , group 2 received 400 mg single-dose albendazole administration and group 3 received a 60000 μg vitamin A capsule combined with 400 mg single-dose albendazole at the beginning of the study . The follow-up period was for 6 months . Anthropometry and biochemical index about Fe metabolism were measured before and after intervention . A total of 209 pre-school anaemic children were r and omly divided into three intervention groups ( sixty-four , sixty-two and sixty for groups 1 , 2 and 3 , respectively ) . The mean age of the children in the study was 4·4 ( sd 0·7 ) years and 50·5 % of the children were female ( 94/186 ) . After a follow-up period of 6 months , the levels of serum retinol , ferritin , transferrin receptor-ferritin index and body total Fe content of children in group 3 were significantly higher compared with children in groups 1 and 2 ( P proportion of vitamin A deficiency , marginal vitamin A deficiency and Fe deficiency among children in group 3 were markedly lower compared with children in groups 1 and 2 ( P ) . Albendazole plus vitamin A administration showed more efficacy on the improvement of serum retinol and Fe metabolic status",
"OBJECTIVE The aim of this study was to evaluate the effectiveness of a widespread vitamin A supplementation programme and to describe indicators of compliance with the programme in Indonesia . DESIGN Prospect i ve cohort study . Children 's anthropometric data were gathered at baseline ( June 2000 ) and 4 months later ( 2 months after supplementation in August 2000 ) . Serum retinol , haemoglobin , ferritin , alpha1-acid glycoprotein and C-reactive protein were measured at baseline and at follow-up . Caregivers of the children were interviewed using a question naire . SETTING Semi-urban and rural areas of Semarang district , Central Java , Indonesia . SUBJECTS Children aged 1 - 5 years . RESULTS After the supplementation , the proportion of children with a low concentration of retinol decreased in recipients from 18.8 to 14.5 % . However , in non-recipients , the prevalence of vitamin A deficiency increased from 31.9 to 37.5 % , this prevalence being significantly higher than in recipients . A significant decrease occurred in the proportion of recipients with low ferritin ( 26.5 to 16.2 % ) and haemoglobin ( 25.7 to 15.3 % ) , whereas the proportions did not show a significant change after supplementation for non-recipients . Modest linear growth was detected in recipients after supplementation but there was no effect on ponderal growth . The coverage rate of the supplementation in the study areas was 60 % . There was an association between compliance of the caregivers and their knowledge about the potential benefit of vitamin A supplementation , the place where sick children were taken and age of the children . CONCLUSIONS The vitamin A supplementation programme marginally decreased the proportion of vitamin A deficiency and had a marginal effect on the nutritional status of recipients . More than one micronutrient intervention is needed to increase the effectiveness of the supplementation programme . To increase compliance and coverage in the supplementation programme , nutrition communication and private healthcare practice s need to be included in the programme",
"The objective of this study was to determine the impact of Vitamin A supplementation on health status and absenteeism of school children . A r and omized double blind placebo controlled trial over a period of 13 months was conducted in a rural area of Sri Lanka involving 613 school children attending Grade s 1 - 5 ( aged 5 to 13 years ) . Children were assigned to either 200,000 IU of Vitamin A ( n=297 ) or placebo ( n=316 ) once every 4 months . Socio-demographic data were obtained at baseline , and anthropometry and haemoglobin concentrations were assessed at baseline and post intervention . Serum vitamin A concentrations were assayed by HPLC in a subgroup of children ( n=193 ) before administration of each dose . School absenteeism was recorded . The two groups of children were similar at baseline in all variables . The subgroup of children was comparable to the main study population . The prevalence of vitamin A deficiency ( Changes in anthropometric indices and haemoglobin concentrations were similar in the two groups . The major causes for absenteeism were non-health causes and supplemented children lost a fewer number of school days due to illness than placebo children ( p=0.053 ) . Vitamin A concentrations improved with each dose and the improvement was greater with better compliance . Vitamin A supplementation with 200,000 IU every 4 months over 13 months improved vitamin A status and school attendance but not anthropometric status of these children",
"Pregnancy exacerbates vitamin A ( VA ) deficiency and anaemia among women in developing countries . Improving circulating haemoglobin ( Hb ) requires erythrocyte production and availability of iron . Insulin-like growth factor- 1 ( IGF-1 ) functions in erythropoiesis , but its association with VA status and pregnancy-associated anaemia has not been studied . The aim of this study was to examine the relationship between serum retinol , IGF-1 , and Hb among pregnant women in extant sample s collected during a placebo-controlled trial of VA and beta-carotene ( BC ) supplementation in rural Nepal conducted from 1994 to 1997 . Mid-pregnancy serum IGF-1 was measured in serum from n=589 r and omly selected women of n=1186 in whom anthropometric , VA ( retinol ) and iron ( Hb , erythrocyte zinc protoporphyrin ( ZP ) , and ferritin ) status data were available . Associations of IGF-1 with retinol , Hb or anaemia , and iron status were determined using multiple linear and logistic regression . Path analysis was used to explore the role of IGF-1 as a mediator between retinol and Hb , accounting for iron status . A 2.6 g/L increase in IGF-1 was observed per 0.1 mol/L increment in retinol ( p Hb increased with each quartile of IGF-1 , and odds of anaemia declined 68.8 % from the 1st to 4th quartile . Improved iron status indicators explained only 29.1 % of the association between IGF-1 and Hb , while IGF-1 explained 25.6 % of the association between retinol and Hb . Increasing IGF-1 was likely one mechanism by which retinol improved circulating Hb in pregnant women of rural Nepal , although IGF-1 worked primarily through pathways independent of improved iron status indicators , perhaps by stimulating erythrocyte production",
"About 450 pregnant women from a low-income group were recruited to study the effect of vitamin A supplementation on plasma vitamin A levels in the mother and cord and on the birth weights of the neonates . Results showed that supplementation with 1800 micrograms vitamin A/d for more than 12 weeks prevented the decline in plasma vitamin A that otherwise occurs during the last few weeks of pregnancy . This improvement in maternal values for vitamin A at a critical time of development favourably affected availability to the fetus , as reflected by the marked elevation in cord levels . Supplementation for a period of 12 weeks was found to be sufficient , since subsequent discontinuation did not alter the beneficial response . Apart from increasing maternal and cord vitamin A levels , vitamin A supplementation along with iron prevented , in this study , the significant decline in haemoglobin occurring at 26 - 28 weeks of gestation . The birth weights were not altered by vitamin A supplementation",
"Nutritional anaemia , thought to be caused by iron deficiency , affects 50 - 70 % of pregnant women in the developing world . The influence of vitamin A and iron supplementation was studied in anaemic pregnant women in West Java , in a r and omised , double-masked , placebo-controlled field trial . 251 women aged 17 - 35 years , parity 0 - 4 , gestation 16 - 24 weeks , and haemoglobin between 80 and 109 g/L were r and omly allocated to four groups : vitamin A ( 2.4 mg retinol ) and placebo iron tablets ; iron ( 60 mg elemental iron ) and placebo vitamin A ; vitamin A and iron ; or both placebos , all daily for 8 weeks . Maximum haemoglobin was achieved with both vitamin A and iron supplementation ( 12.78 g/L , 95 % Cl 10.86 to 14.70 ) , with one-third of the response attributable to vitamin A ( 3.68 g/L , 2.03 to 5.33 ) and two-thirds to iron ( 7.71 g/L , 5.97 to 9.45 ) . After supplementation , the proportion of women who became non-anaemic was 35 % in the vitamin-A-supplemented group , 68 % in the iron-supplemented group , 97 % in the group supplemented with both , and 16 % in the placebo group . Improvement in vitamin A status may contribute to the control of anaemic pregnant women",
"Lack of protein and vitamin A influences the growth of student in impoverished mountain areas . The aim of the study was to assess the effects of egg and vitamin A supplementation on hemoglobin , serum retinol and anthropometric indices of 10 - 18 years old students of a low socioeconomic status . A total number of 288 students from four boarding schools were r and omly selected by using cluster sampling method in Chongqing , and they were assigned into supplement group and control group non-r and omly . Students in supplement group received a single 200,000 international units vitamin A and 1 egg/day ( including weekends ) for 6 months . The control group did not receive any supplementation . We measured hemoglobin , serum retinol and height and weight at baseline and after supplementation . The supplementation increased the mean hemoglobin concentration by 7.13 g/L compared with 1.38 g/L in control group ( p mean serum retinol concentration by 0.31 μmol/L compared with 0.09 μmol/L in the control group ( p=0.005 ) , the mean height-for-age z score by 0.05 compared with 0.03 in the control group ( p=0.319 ) , the mean weight-for-age z score by 0.05 compared with -0.12 in the control group ( p that egg and vitamin A supplementation is an effective , convenient , and practical method to improve the levels of hemoglobin , serum retinol and prevent the deterioration of growth in terms of weight for primary and middle school students from outlying poverty-stricken areas . Our intervention did not have a beneficial effect on linear growth",
"INTRODUCTION Although studies suggest that vitamin A or its metabolites influence the synthesis of erythropoietin in vitro and in animal models , it is unclear whether vitamin A supplementation increases plasma erythropoietin concentrations in humans . OBJECTIVE To determine whether daily vitamin A supplementation increases plasma erythropoietin concentrations in pregnant women with a high prevalence of anaemia . METHODS A r and omized , double-blind , controlled clinical trial was conducted to examine the effect of daily vitamin A ( 3000 microg retinol equivalent ) , iron ( 30 mg ) , and folate ( 400 microg ) versus iron ( 30 mg ) and folate ( 400 microg ) ( control ) on haemoglobin and plasma erythropoietin concentrations in 203 pregnant women in Malawi , Africa . RESULTS Mean gestational age at enrollment was 23 wk , at which time 50 % of the women were anaemic ( haemoglobin g/L ) . Mean ( + /-SEM ) change in haemoglobin from enrollment to 38 wk was 4.7+/-1.6 g/L ( p=0.003 ) and 7.3+/-2.3 g/L ( p=0.003 ) in the vitamin A and control groups , respectively . Mean change in plasma erythropoietin concentrations from enrollment to 38 wk was 2.39+/-5.00 ( p=0.63 ) and -2.87+/-3.92 IU/L ( p=0.46 ) in the vitamin A and controls groups , respectively . There were no significant differences between vitamin A and control groups in the slope of the regression line between log10 erythropoietin and haemoglobin at enrollment or 38 wk , and between enrollment and follow-up within either group . CONCLUSIONS Vitamin A supplementation does not appear to increase haemoglobin and plasma erythropoietin concentrations among pregnant women with a high prevalence of anaemia in Malawi"
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BACKGROUND Palm oil ( PO ) may be an unhealthy fat because of its high saturated fatty acid content . OBJECTIVE The objective was to assess the effect of substituting PO for other primary dietary fats on blood lipid-related markers of coronary heart disease ( CHD ) and cardiovascular disease ( CVD ) . DESIGN We performed a systematic review and meta- analysis of dietary intervention trials . Studies were eligible if they included original data comparing PO-rich diets with other fat-rich diets and analyzed at least one of the following CHD/CVD biomarkers : total cholesterol ( TC ) , low-density lipoprotein ( LDL ) cholesterol , high-density lipoprotein ( HDL ) cholesterol , TC/HDL cholesterol , LDL cholesterol/HDL cholesterol , triacylglycerols , apolipoprotein A-I and B , very-low-density lipoprotein cholesterol , and lipoprotein(a ) . RESULTS Fifty-one studies were included . Intervention times ranged from 2 to 16 wk , and different fat substitutions ranged from 4 % to 43 % . Comparison of PO diets with diets rich in stearic acid , monounsaturated fatty acids ( MUFAs ) , and polyunsaturated fatty acids ( PUFAs ) showed significantly higher TC , LDL cholesterol , apolipoprotein B , HDL cholesterol , and apolipoprotein A-I , whereas most of the same biomarkers were significantly lower when compared with diets rich in myristic/lauric acid . Comparison of PO-rich diets with diets rich in trans fatty acids showed significantly higher concentrations of HDL cholesterol and apolipoprotein A-I and significantly lower apolipoprotein B , triacylglycerols , and TC/HDL cholesterol . Stratified and meta-regression analyses showed that the higher concentrations of TC and LDL cholesterol , when PO was substituted for MUFAs and PUFAs , were not significant in young people and in subjects with diets with a lower percentage of energy from fat . CONCLUSIONS Both favorable and unfavorable changes in CHD/CVD risk markers occurred when PO was substituted for the primary dietary fats , whereas only favorable changes occurred when PO was substituted for trans fatty acids . Additional studies are needed to provide guidance for policymaking
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"We have compared the effects of three different margarines , one based on palm oil ( PALM-margarine ) , one based on partially hydrogenated soybean oil ( TRANS-margarine ) and one with a high content of polyunsaturated fatty acids ( PUFA-margarine ) , on serum lipids in 27 young women . The main purpose of the study was to test if replacement of trans fatty acids in margarine by palmitic acid results in unfavorable effects on serum lipids . The sum of saturated fatty acids ( 12∶0 , 14∶0 , 16∶0 ) was 36.3 % of total fatty acids in the PALM-diet , the same as the sum of saturated ( 12∶0 , 14∶0 , 16∶0 ) ( 12.5 % ) and trans ( 23.1 % ) fatty acids in the TRANS-diet . This sum was 20.7 % in the PUFA-diet . The content of oleic acid was 37.9 , 35.2 , and 38.6 % , respectively , in the three diets , whereas linoleic acid amounted to 16 , 13.5 , and 27.3 % , respectively . Total fat provided 30–31 % and the test margarines 26 % of total energy in all three diets . The subjects consumed each of the diets for 17 d in a Latin-square crossover design . There were no significant differences in total cholesterol , low density lipoprotein (LDL)-cholesterol and apolipoprotein B ( apoB ) between the TRANS- and the PALM-diets . High density lipoprotein (HDL)-cholesterol and apoA-I were significantly higher on the PALM-diet compared to the TRANS-diet whereas the ratio of LDL-cholesterol to HDL-cholesterol was lower , although not significantly ( P=0.077 ) on the PALM-diet . Total cholesterol , LDL-cholesterol , and apoB were significantly lower on the PUFA-diet compared to the two other diets . HDL-cholesterol was not different on the PALM- and the PUFA-diets but it was significantly lower on the TRANS-diet compared to the PUFA diet . Compared to the PUFA-diet the ratio of LDL-to HDL-cholesterol was higher on both the PALM- and the TRANS-diets whereas apoA-I was not different . Triglycerides and lipoprotein ( a ) were not significantly different among the three diets . We concluded that nutritionally , palmitic acid from palm oil may be a reasonable alternative to trans fatty acids from partially hydrogenated soybean oil in margarine if the aim is to avoid trans fatty acids . A palm oil-based margarine is , however , less favorable than one based on a more polyunsaturated vegetable oil",
"Knowledge about the effects of dietary fats on sub clinical inflammation and cardiovascular disease risk are mainly derived from studies conducted in Western population s. Little information is available on South East Asian countries . This current study investigated the chronic effects on serum inflammatory markers , lipids , and lipoproteins of three vegetable oils . Healthy , normolipidemic subjects ( n = 41 ; 33 females , 8 males ) completed a r and omized , single-blind , crossover study . The subjects consumed high oleic palm olein ( HOPO diet : 15 % of energy 18:1n-9 , 9 % of energy 16:0 ) , partially hydrogenated soybean oil ( PHSO diet : 7 % of energy 18:1n-9 , 10 % of energy 18:1 trans ) and an unhydrogenated palm stearin ( PST diet : 11 % of energy 18:1n-9 , 14 % of energy 16:0 ) . Each dietary period lasted 5 weeks with a 7 days washout period . The PHSO diet significantly increased serum concentrations of high sensitivity C-reactive protein compared to HOPO and PST diets ( by 26 , 23 % , respectively ; P decreased interleukin-8 ( IL-8 ) compared to PST diet ( by 12 % ; P PHSO diet , and also PST diet , significantly increased total : HDL cholesterol ratio compared to HOPO diet ( by 23 , 13 % , respectively ; P PST diet having a lesser effect than the PHSO diet ( by 8 % ; P < 0.05 ) . The use of vegetable oils in their natural state might be preferred over one that undergoes the process of hydrogenation in modulating blood lipids and inflammation",
"BACKGROUND Structured lipids are being incorporated into foods to reduce their energy value . One such lipid is rich in stearic acid . OBJECTIVE The objective of this study was to compare the effects on plasma lipids of a stearic acid-rich triacylglycerol and a fat rich in palmitic acid in hypercholesterolemic subjects . DESIGN Fifteen subjects with an average plasma cholesterol concentration of 6.13 + /- 0.80 mmol/L initially ate a low-fat diet for 2 wk ( run-in period ) , followed in r and om order and blinded fashion by 2 high-fat diets ( for 5 wk each ) containing foods derived from margarines rich either in palmitic acid or in the structured , stearic acid-rich triacylglycerol . RESULTS Plasma cholesterol concentrations with the low-fat , the stearic acid-rich , and the palmitic acid-rich diets were not significantly different ( 5.35 + /- 0.83 , 5.41 + /- 0.78 , and 5.52 + /- 0.68 mmol/L , respectively ) but were significantly lower ( P HDL cholesterol nor plasma triacylglycerol differed significantly among the 3 study diets . CONCLUSION A similar increase in the intake of stearic and palmitic acids ( differing by approximately 5 % of total energy ) to ensure a high fat intake result ed in plasma total and LDL-cholesterol concentrations that did not differ significantly from concentrations measured during a period of low-fat intake",
"Although dietary trans fatty acids can affect plasma lipoproteins negatively in humans , no direct comparison with specific saturated fatty acids has been reported , even though trans fatty acids were design ed to replace saturates in foods and food processing . In this study , dietary trans 18:1 [ elaidic acid at 5.5 % energy ( en ) ] was specifically exchanged for cis 18:1 , 16:0 or 12:0 + 14:0 in 27 male and female subjects consuming moderate fat ( 31 % en ) , low cholesterol ( whole food diets during 4-wk diet periods in a crossover design . The trans-rich fat significantly elevated total cholesterol and LDL cholesterol relative to the 16:0-rich and 18:1-rich fats and uniquely depressed HDL cholesterol relative to all of the fats tested . Trans fatty acids also elevated lipoprotein ( a ) [ Lp(a ) ] values relative to all dietary treatments . Furthermore , identical effects on lipoproteins were elicited by 16:0 and cis 18:1 in these subjects . The current results suggest that elaidic acid , one of the principal trans isomers produced during industrial hydrogenation of edible oils , adversely affects plasma lipoproteins . Thus , the negative effect of elaidic acid on the lipoprotein profile of humans appears to be unmatched by any other natural fatty acid(s )",
"BACKGROUND The fatty acid content and saturation degree of the diet can modulate HDL composition and cholesterol efflux . OBJECTIVE We studied the modifications in plasma lipoprotein particles and serum capacity to stimulate cholesterol efflux induced by different fatty acids . DESIGN Seventeen women and 24 men followed in the same sequence 4 diets containing 35 % of total energy as fat . The saturated fat diet contained 17 % palm oil ; the monounsaturated fat diet , 20.9 % olive oil ; the n-6 polyunsaturated fat diet , 12.5 % sunflower oil ; and the n-3 polyunsaturated fat diet , sunflower oil supplemented with 4 - 4.5 g fish oil/d . Each phase lasted 4 - 5 wk . RESULTS In both sexes , apolipoprotein ( apo ) A-I concentrations were significantly lower with unsaturated fat diets than with the saturated fat diet , but concentrations of lipoproteins containing only apo A-I ( Lp A-I ) were lower only in the men . Concentrations of lipoproteins containing both apo A-I and apo A-II ( Lp A-I : A-II ) were lower with both polyunsaturated fat diets in the women but significantly higher in the men . Lp E concentrations were significantly higher with the 2 polyunsaturated fat diets . Lp E non-B particle concentrations were not modified in the men but were significantly higher in the women in both polyunsaturated fat phases . Lp C-III concentrations were higher with the saturated fat diet only in the men . The serum sample s taken after the n-3 polyunsaturated fat phase were the most efficient for extracting cellular cholesterol in both sexes . CONCLUSIONS The monounsaturated and polyunsaturated fat diets were healthier , producing a better lipid profile . The n-3 polyunsaturated fat diet increased the capacity of serum to promote the efflux of cholesterol from cells in culture",
"The effect of fats high in individual , prevalent saturated dietary fatty acids on lipoproteins and hemostatic variables in young healthy subjects was evaluated in a r and omized strictly controlled metabolic feeding study . Three experimental diets : shea butter ( S ; 42 % stearic acid ) , palm oil ( P ; 43 % palmitic palmitic acid ) , and palm-kernel oil with high-oleic sunflower oil ( ML ; 10 % myristic acid , 30 % lauric acid ) were served to 15 men for 3 wk each , separated by washout periods . Diet S compared with diet P result ed in significant reduction in plasma cholesterol ( 22 % ) LDL cholesterol ( 26 % ) , apolipoprotein B ( 18 % ) , HDL cholesterol ( 12 % ) , apolipoprotein A-I ( 13 % ) , and a 13 % lower factor VII coagulant activity ( P = 0.001 ) . Similar differences were observed between diets S and ML . In conclusion , intake of shea butter high in stearic acid favorably affects blood lipids and factor VII coagulant activity in young men , compared with fats high in saturated fatty acids with 12 - 16 carbons",
"The hypothesis that myristic acid ( C14:0 ) has a stronger cholesterol-increasing potential than does palmitic acid is based on very few experimental observations . A r and omized , strictly controlled dietary study was therefore design ed to investigate the effect of a synthetic fat that was high in myristic acid , and palm oil , which is high in palmitic acid , on lipoproteins and hemostatic variables . Twelve men were served two diets ( 40 % of energy as fat ) with 41 % of fat as myristic ( diet M ) or palmitic acid ( diet P ) for 3 wk with 1 mo between the two dietary schedules . Plasma HDL cholesterol was 8 % higher with diet M than with diet P : 1.10 + /- 0.06 ( mean + /- SEM ) vs 1.01 + /- 0.05 mmol/L ( P factor VII coagulant ( F VIIc ) activity to 98 % ( 77 - 117 % ) vs 96 % ( 71 - 109 % ) ( medians and ranges ) after diet P ( P = 0.02 ) . Total and LDL-cholesterol concentrations did not differ between the diets . In conclusion , the myristic acid test fat was not more cholesterolemic than was palm oil , but it did induce a minor rise in F VIIc activity",
"Twenty-one healthy normocholesterolemic young adults , men and women , completed a r and omized 30-d/30-d crossover comparison of the effect of palmolein and olive oil on plasma lipids . The subjects were free-living volunteers who changed to low-fat diets to which one of the test oils was added ( used as a spread , for baking , or for frying ) in turn . Complete food records were kept throughout : the test oils were compared at 17 % of total dietary energy . Under the conditions of this experiment plasma total and low-density-lipoprotein ( LDL ) cholesterol were almost identical with the two oils , so that when the palmitic acid ( 16:0 ) in palm oil replaced oleic acid ( 18:1 ) in olive oil the expected increase in LDL cholesterol was not seen . These results indicate that 16:0 , though saturated , is not always a plasma cholesterol-raising fatty acid . Palmolein is rich in vitamin E , alpha-tocopherol , and especially tocotrienols , but the latter were barely detectable in plasma",
"In a double-blind crossover study , 17 normocholesterolemic male volunteers were fed carefully design ed whole-food diets in which 5 % of energy was exchanged between palmitic ( 16:0 ) and lauric + myristic acids ( 12:0 + 14:0 ) whereas all other fatty acids were held constant . Resident males received each diet during separate 4-wk periods . The test diets supplied approximately 30 % of energy as fat and 200 mg cholesterol/d . Compared with the 12:0 + 14:0-rich diet , the 16:0-rich diet produced a 9 % lower serum cholesterol concentration , reflected primarily by a lower ( 11 % ) low-density-lipoprotein-cholesterol concentration and , to a lesser extent , high-density-lipoprotein cholesterol . No diet-induced changes were noted in the cholesterol content of other lipoproteins , nor did exchange of saturated fatty acids affect the triglyceride concentration in serum or lipoprotein fractions . These data indicate that a dietary 12:0 + 14:0 combination produces a higher serum cholesterol concentration than does 16:0 in healthy normocholesterolemic young men fed a low-cholesterol diet",
"We examined the effect of the positional distribution of fatty acids within dietary triglycerides on serum lipoproteins . Sixty subjects consumed two diets of equal fatty acid composition for 3 wk each . In the palm oil diet 82 % of palmitic acid was attached to the outer two carbon atoms of glycerol , and 18 % to the middle carbon . In the diet rich in enzymatically modified palm oil these figures were 35 % and 65 % , respectively . On the modified-fat diet , average lipoprotein concentrations showed nonsignificant ( P > 0.13 ) increases of 0.06 mmol/L for total , 0.03 mmol/L for HDL , and 0.04 mmol/L for LDL cholesterol compared with palm oil . The small increases in total and LDL cholesterol were statistically significant in the men ( n = 23 ) but not in the women ( n = 37 ) . The ratio of HDL to LDL cholesterol and serum triglyceride concentrations were unchanged . Thus , a large difference in dietary fatty acid configuration had little effect on lipoprotein concentrations in humans",
"Palm oil and soybean oil are the 2 most widely used cooking oils in the world . Palm oil is consumed mainly in developing countries , where morbidity and mortality due to cardiovascular disease ( CVD ) are on the rise . Although cl aims about adverse or protective effects of these oils are commonly made , there are no epidemiologic studies assessing the association between these oils and cardiovascular disease endpoints . We examined whether consumption of palm oil relative to soybean oil and other unsaturated oils ( predominantly sunflower ) is associated with myocardial infa rct ion ( MI ) in Costa Rica . The cases ( n = 2111 ) were survivors of a first acute MI and were matched to r and omly selected population controls ( n = 2111 ) . Dietary intake was assessed with a vali date d semiquantitative FFQ . Adipose tissue profiles of essential fatty acids were assessed to vali date cooking oil intake and found to be consistent with self-reported major oils used for cooking . The data were analyzed using conditional logistic regression . Palm oil users were more likely to have an MI than users of soybean oil [ odds ratio ( OR ) = 1.33 ; 95 % CI : 1.08 - 1.63 ] or other cooking oils ( OR = 1.23 ; CI : 0.99 - 1.52 ) , but they did not differ from users of soybean oil with a high trans-fatty acid content ( OR = 1.14 ; CI : 0.84 - 1.56 ) . These data suggest that as currently used in Costa Rica , and most likely in many other developing countries , the replacement of palm oil with a polyunsaturated nonhydrogenated vegetable oil would reduce the risk of MI",
"The degree to which different saturated fatty acids exert their cholesterol-raising effects is still unknown . Therefore , we studied the effect on serum lipids and lipoproteins of diets rich in lauric , palmitic , or oleic acids . Eighteen women and 14 men consumed in r and om order three experimental diets , each for 6 wk . The diets consisted of solid foods and contained 40 % of energy as fat , of which 28 % was supplied by the experimental fats . The fat high in lauric acid was a mixture of palm kernel oil ( 75 % ) and a high-oleic acid sunflower oil ( 25 % ) ; the fat high in palmitic acid consisted of dairy fat ( 55 % ) , palmstearin ( 36 % ) , and sunflower oil ( 9 % ) ; and the fat high in oleic acid consisted of dairy fat ( 37 % ) and sunflower oil ( 63 % ) . The calculated nutrient composition was the same in each diet except for approximately equal to 8.5 % of energy , which was provided by lauric , palmitic , or oleic acids . With the lauric acid diet the subjects ' serum total cholesterol concentration increased by 0.22 mmol/L ( P = 0.0121 ; 95 % CI : 0.02 , 0.41 mmol/L ) as compared with the palmitic acid diet and by 0.48 mmol/L ( P oleic acid diet . Total cholesterol concentrations with the palmitic acid diet were 0.26 mmol/L ( P = 0.0012 ; 95 % CI : 0.07 , 0.46 mmol/L ) higher than with the oleic acid diet . High-density-lipoprotein (HDL)-cholesterol concentrations increased by 0.12 mmol/L ( P = 0.006 ; 95 % CI : 0.04 , 0.20 mmol/L ) with the lauric acid compared with the palmitic acid diet and by 0.14 mmol/L ( P oleic acid diet . HDL-cholesterol concentrations with the palmitic acid and the oleic acid diet were the same . No effects were seen in serum triacylglycerol and lipoprotein(a ) concentrations . We conclude that both lauric and palmitic acids are hypercholesterolemic compared with oleic acid . Lauric acid raises total cholesterol concentrations more than palmitic acid , which is partly due to a stronger rise in HDL cholesterol",
"Increased HDL-cholesterol levels have been associated with lower coronary heart disease ( CHD ) risk . However , HDL are heterogeneous lipoproteins , and particles enriched in apolipoprotein ( Apo ) AII have been associated with increased CHD risk . We examined the effect of dietary intervention on HDL composition in 14 postmenopausal women subjected to two consecutive diet periods , i.e. , an oleic acid sunflower oil diet followed by a palmolein diet , each lasting 4 wk . The linoleic acid was kept at 4 % total energy and the cholesterol intake at 400 mg/d . The palmolein diet increased serum total cholesterol ( TC ) ( P phospholipids ( P Apo AII ( P HDL cholesterol ( P HDL lipids ( P HDL proteins ( P HDL total mass ( P HDL cholesterol/Apo AI ratio was increased 22.0 % ( P HDL cholesterol/Apo AII and the Apo AI/Apo AII ratios were decreased 19.4 % ( P cholesterolemia status ( 6.2 mmol/L ) , the most significant changes ( P Apo AII levels . Moreover , a significant dietary oil by cholesterol level interaction was found for Apo AII and the HDL cholesterol/Apo AII ratio . In summary , a palmolein diet increased TC and HDL cholesterol compared with oleic acid sunflower oil diet ; however , the increase in Apo AII but not in Apo AI suggests the impairment of reverse cholesterol transport and potentially an increase in CHD risk . This effect was more marked in women with serum TC > 6.2",
"The aim was to establish whether interesterification of oils , an alternative to the use of trans fatty acids in margarine manufacture , adversely affects plasma lipids . Twenty-seven hypercholesterolemic men participated in a double-blind , crossover trial of three margarines : 1 ) high-linoleic acid , moderate trans fatty acids ; 2 ) high-palm oil blend ( predominantly lauric , myristic , palmitic , oleic , and linoleic acids ) ; and 3 ) an interesterified form of the high-palm oil margarine . Both high-palm oil margarines led to similar low-density-lipoprotein ( LDL ) cholesterol concentrations ( 4.43 + /- 0.94 and 4.54 + /- 0.88 mmol/L , respectively ) , which were significantly higher than the LDL concentrations after the high-linoleic acid margarine ( 4.02 + /- 0.85 mmol/L , P plasma chylomicrons . This study shows that interesterification of oils used to harden margarines does not raise plasma cholesterol more than does the margarine 's constituent fatty acids",
"The effects on serum lipids of palm oil ( PA ) used in Chinese diets were compared with those of soybean oil ( SO ) , peanut oil ( PE ) and lard ( LA ) in normocholesterolemic subjects and with that of PE in hypercholesterolemic subjects . Normocholesterolemic subjects [ 120 men , 18 - 25 y , total cholesterol ( TC ) 2.8 - 5.0 mmol/L ] were assigned to four groups to consume test diets for six consecutive weeks after a run-in period of 3 wk . About 30 % of dietary energy was derived from fat , 75 - 80 % of which came from test oils . In comparison with the entry level , the average serum TC and LDL cholesterol ( LDL-C ) were 6.7 and 13.1 % lower , respectively , in the PA group and 22.8 and 30.7 % higher , respectively , ( P serum TC , LDL-C and the ratio of TC/HDL cholesterol ( HDL-C ) in the PA group were significantly lower than those of the LA group . Hypercholesterolemic subjects ( 31 men , 20 women , 32 - 68 y , TC 5.5 - 7.0 mmol/L ) were divided into two groups . For 6 wk , one group ( 15 men , 10 women ) consumed the PA diet ; another group ( 16 men , 9 women ) consumed the PE diet . After a 3-wk interval , the two groups interchanged diets for another 6 wk . The test diets again contained about 30 % energy from fat , 60 - 65 % of which came from test oils . Compared with entry values , the PA diet caused significant reductions in serum TC , LDL-C and TC/HDL-C during the first 6 wk and also a significant reduction in TC/HDL-C during the second 6 wk . The PE diet had no significant influence on serum lipids in either experimental period",
"Although medium-chain triacylglycerols ( MCTs , composed of medium-chain fatty acids 8:0 and 10:0 ) have long been described as having neutral effects on serum cholesterol concentrations , experimental evidence supporting this cl aim is limited . In a r and omized , crossover , metabolic-ward study , we compared the lipid effects of a natural food diet supplemented with either MCTs , palm oil , or high oleic acid sunflower oil in nine middle-aged men with mild hypercholesterolemia . Rather than having a neutral effect , MCT oil produced total cholesterol concentrations that were not significantly different from those produced by palm oil ( MCT oil : 5.87 + /- 0.75 mmol/L ; palm oil : 5.79 + /- 0.72 mmol/L ) but significantly higher than that produced by high oleic acid sunflower oil ( 5.22 + /- 0.52 mmol/L ) . Low-density-lipoprotein (LDL)-cholesterol concentrations paralleled those of total cholesterol . MCT oil tended to result in higher triacylglycerol concentrations than either palm oil or high oleic acid sunflower oil , but this difference was not significant . There were no differences in high-density-lipoprotein cholesterol concentrations . The palmitic acid and total saturated fatty acid content of plasma triacylglycerols in the MCT-oil diet was not significantly different from that in the palm oil diet . On the basis of percentage of energy , this study suggests that medium-chain fatty acids have one-half the potency that palmitic acid has at raising total and LDL-cholesterol concentrations",
"The effects of lauric acid ( C12:0 ) on plasma lipids and lipoproteins were compared with the effects of palmitic acid ( C16:0 ) and oleic acid ( C18:1 ) in a metabolic-diet study of 14 men by using liquid-formula diets fed for 3 wk each in r and om order . Lauric acid was supplied in a synthetic high-lauric oil , palmitic acid was provided by palm oil and oleic acid in oleic-rich sunflower seed oil . The high-lauric oil result ed in higher concentrations of plasma total cholesterol ( 4.94 + /- 0.75 mmol/L [ mean + /- SE ] ) and LDL cholesterol ( 3.70 + /- 0.57 mmol/L ) when compared with high-oleic sunflower oil ( 4.44 + /- 0.54 and 3.31 + /- 0.44 mmol/L , respectively ) , but did not raise total and LDL cholesterol concentrations as much as did palm oil ( 5.17 + /- 0.65 and 3.93 + /- 0.51 mmol/L , respectively ) . No differences were noted in plasma triglycerides or HDL cholesterol . Lauric acid raises total and LDL cholesterol concentrations compared with oleic acid , but is not as potent for increasing cholesterol concentrations as is palmitic acid",
"The effects of two strictly controlled diets , one rich in complex carbohydrates , the other rich in olive oil , on serum lipids were studied in healthy men and women . Serum cholesterol levels fell on average by 0.44 mmol/l in the carbohydrate group and 0.46 mmol/l in the olive oil group . HDL cholesterol levels fell by 0.19 mmol/l in the carbohydrate group and rose by 0.03 mmol/l in the olive oil group . Serum triglycerides rose by 0.19 mmol/l in the carbohydrate group and fell by 0.06 mmol/l in the olive oil group . The changes in both HDL and triglycerides were larger in men than in women . These results clearly show that the olive-oil-rich diet , unlike the complex-carbohydrate-rich diet , caused a specific fall in non-HDL cholesterol while leaving serum triglyceride levels virtually unchanged",
"BACKGROUND Experimental studies have suggested both atherogenic and thrombogenic properties of lipoprotein(a ) [ Lp(a ) ] , depending on Lp(a ) plasma concentrations and varying antifibrinolytic capacity of apolipoprotein(a ) [ apo(a ) ] isoforms . Epidemiological studies may contribute to assessment of the relevance of these findings in the general population . METHODS AND RESULTS This study prospect ively investigated the association between Lp(a ) plasma concentrations , apo(a ) phenotypes , and the 5-year progression of carotid atherosclerosis assessed by high-resolution duplex ultrasound in a r and om sample population of 826 individuals . We differentiated early atherogenesis ( incident nonstenotic atherosclerosis ) from advanced ( stenotic ) stages in atherosclerosis that originate mainly from atherothrombotic mechanisms . Lp(a ) plasma concentrations predicted the risk of early atherogenesis in a dose-dependent fashion , with this association being confined to subjects with LDL cholesterol levels above the population median ( 3.3 mmol/L ) . Apo(a ) phenotypes were distributed similarly in subjects with and without early carotid atherosclerosis . In contrast , apo(a ) phenotypes of low molecular weight emerged as one of the strongest risk predictors of advanced stenotic atherosclerosis , especially when associated with high Lp(a ) plasma concentrations ( odds ratio , 6.4 ; 95 % CI , 2.8 to 14 . 9 ) . CONCLUSIONS Lp(a ) is one of the few risk factors capable of promoting both early and advanced stages of atherogenesis . Lp(a ) plasma concentrations predicted the risk of early atherogenesis synergistically with high LDL cholesterol . Low-molecular-weight apo(a ) phenotypes with a putatively high antifibrinolytic capacity in turn emerged as one of the leading risk conditions of advanced stenotic stages of atherosclerosis",
"The objective of this study was to compare the effects of linoleic acid ( cis , cis-C18:2(n-6 ) ) and its hydrogenation products elaidic ( trans-C18:1(n-9 ) ) and stearic acid ( C18:0 ) on serum lipoprotein levels in humans . Twenty-six men and 30 women , all normolipemic and apparently healthy , completed the trial . Three experimental diets were supplied to every subject for 3 weeks each , in r and om order ( multiple cross-over ) . The Linoleate-diet provided 12.0 % of total energy intake as linoleic acid , 2.8 % as stearic acid , and 0.1 % as trans fatty acids . The Stearate-diet supplied 3.9 energy % as linoleic acid , 11.8 % stearic acid , and 0.3 % trans fatty acids . The Trans-diet provided 3.8 energy % as linoleic acid , 3.0 % stearic acid , and 7.7 % as monounsaturated trans fatty acids , largely elaidic acid ( trans-C18:1(n-9 ) ) . Other nutrients were constant . Fasting blood was sample d at the end of each dietary period . Mean ( + /- SD ) serum LDL cholesterol was 109 + /- 24 mg/dl ( 2.83 + /- 0.63 mmol/l ) on the Linoleate-diet . It rose to 116 + /- 27 mg/dl ( 3.00 + /- 0.71 mmol/l ) on the Stearate-diet ( change , 7 mg/dl or 0.17 mmol/l , P = 0.0008 ) and to 119 + /- 25 mg/dl ( 3.07 + /- 0.65 mmol/l ) on the Trans-diet ( change , 9 mg/dl or 0.24 mmol/l , P less than 0.0001 ) . High density lipoprotein ( HDL ) cholesterol decreased by 2 mg/dl ( 0.06 mmol/l , P less than 0.0001 ) on the Stearate-diet and by 4 mg/dl ( 0.10 mmol/l , P less than 0.0001 ) on the Trans-diet , both relative to linoleic acid . Our findings show that 7.7 % of energy ( mean , 24 g/day ) of trans fatty acids in the diet significantly lowered HDL cholesterol and raised LDL cholesterol relative to linoleic acid . Combination with earlier results ( Mensink , R. P. , and M. B. Katan . 1990 . N. Engl . J. Med . 323 : 439 - 445 ) suggests a linear dose-response relation . Replacement of linoleic acid by stearic acid also caused somewhat lower HDL cholesterol and higher LDL cholesterol levels . Hydrogenation of linoleic acid to either stearic or trans fatty acids produces fatty acids that may increase LDL and decrease HDL cholesterol relative to linoleic acid itself",
"BACKGROUND Despite the high content of palmitic acid , palm olein has been shown to have a neutral effect on plasma cholesterol concentrations when compared with olive oil , which is suggested to be attributable to palmitic acid in the sn-1 and sn-3 position . In contrast , palmitic acid is in the sn-2 position in lard . OBJECTIVE The objective was to investigate the effects of a diet rich in palm olein , fractionated palm oil , olive oil , and lard on plasma blood lipids , inflammatory markers , glucose , and insulin . DESIGN A controlled double-blinded , r and omized 3 × 3 wk crossover dietary intervention study included 32 healthy men who daily replaced part of their habitual dietary fat intake with ~ 17 % of energy from palm olein , olive oil , or lard , respectively . RESULTS Compared with intake of olive oil , palm olein and lard increased total cholesterol and LDL cholesterol ( P ) . Palm olein result ed in a lower plasma triacylglycerol concentration than did olive oil ( P in plasma HDL-cholesterol , high-sensitivity C-reactive protein , plasminogen activator-1 , insulin , and glucose concentrations . CONCLUSIONS The current study did not support the previous finding that the effect of palm olein on total plasma cholesterol and LDL cholesterol in healthy individuals with normal plasma cholesterol concentrations is neutral compared with that of olive oil . Thus , sn-positioning was not confirmed to be important with regard to the effect on plasma cholesterol . The relatively lower plasma triacylglycerol concentration after the palm olein diet than after the olive oil diet was unexpected . This trial is registered at clinical trials.gov as NCT00743301",
"The effect of additional dietary trans fatty acids ( 7 % energy ) on plasma lipids was assessed in a double-blind comparison of four separate diets : 1 , enriched with butter fat ( lauric-myristic-palmitic ) ; 2 , oleic acid-rich ; 3 , elaidic acid-rich ; 4 , palmitic acid-rich . The total dietary period was 11 weeks and comprised normal foods plus specific fat supplements . In 27 mildly hypercholesterolemic men , total and LDL cholesterol were significantly lower during the 3-week oleic acid-rich diet , and were similar during the other three diets . For the four diets LDL cholesterol levels were in mg/dl : 1 , 163 ; 2 , 151 ; 3 , 165 ; 4 , 161 . HDL cholesterol was significantly higher with the palmitic acid-rich diet , 42 mg/dl , compared with elaidic acid , 38 mg/dl , which in turn was not lower than with oleic acid , 38 mg/dl . Plasma elaidic acid concentration rose seven-fold with the trans fatty acid diet but did not increase the vulnerability of LDL to oxidative change . The elaidic acid-rich diet led to significant elevations in the level of Lp[a ] compared to all the other test diets . The Lp[a ] level increased to 296 + /- 220 U/l in the elaidic acid-rich period from 235 + /- 182 ( mean + /- SD ) in the first ( \" butter \" ) period ( P less than 0.001 ) compared with 249 + /- 204 in the palmitic acid period ( P less than 0.001 ) and 236 + /- 201 in the oleic acid period ( NS ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The cholesterol-raising effect of dietary saturated fatty acids is largely accounted for by lauric , myristic , and palmitic acids . Dairy fat is a major source of myristic acid , and palm oil is especially rich in palmitic acid . Myristic acid is suspected of being much more cholesterolemic than palmitic acid , but direct comparisons have been lacking . We therefore fed 36 women and 23 men three diets that differed from each other in palmitic , oleic , and myristic acid content by about 10 % of total energy . We used palm oil , high-oleic acid sunflower oil , and a specially produced high-myristic acid fat to achieve these differences . Each diet was consumed for 3 weeks in r and om order . Mean serum cholesterol was 4.53 mmol/L on the high-oleic acid diet , 4.96 mmol/L on the palmitic acid diet , and 5.19 mmol/L on the myristic acid diet ( P acid raised low-density lipoprotein ( LDL ) cholesterol by 0.11 mmol/L , high-density lipoprotein ( HDL ) cholesterol by 0.12 mmol/L , and apolipoprotein ( apo ) A-I by 7.2 mg/dL relative to palmitic acid ; increases relative to oleic acid were 0.50 mmol/L for LDL cholesterol , 0.15 mmol/L for HDL cholesterol , 6.0 mg/dL for apoB , and 8.9 mg/dL for apoA-I ( P HDL cholesterol and apoA-I levels on the palmitic and oleic acid diets were the same . None of the responses differed significantly between woman and men . Myristic acid and palmitic acid both caused high LDL cholesterol and apoB levels and low HDL to LDL ratios . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Objective : To determine whether healthy males who consumed increased amounts of dietary stearic acid compared with increased dietary palmitic acid through the consumption of commercially available foods , exhibited any changes in plasma lipids , platelet aggregation or platelet activation status . Design : A r and omised cross-over dietary intervention . Subjects and interventions : Nine free-living healthy males consumed two experimental diets ( stearic acid enriched , diet S , and palmitic acid enriched , diet P ) for 3 weeks in a r and omised cross-over design separated by a 3 week washout phase . The diets consisted of ∼30 % of energy as fat ( 30 % of which was derived from the treatment diets ) providing ∼13 g/day as stearic acid and 17 g/day as palmitic acid on diet S and ∼7 g/day as stearic acid and 22 g/day as palmitic acid on diet P. The dietary ratio of stearic to palmitic acids was 0.76 on diet S compared with 0.31 on diet P. Blood sample s were collected on days 0 and 21 of each dietary period . Results : LDL cholesterol levels and platelet aggregation response to the agonist ADP were significantly decreased ( P in plasma lipids , platelet aggregation , mean platelet volume and platelet reactivity between diets . There were no significant changes in stearic or palmitic acid levels in plasma phospholipid or triacylglycerol . There was a significant difference in palmitic acid levels in platelet phospholipids between the two diets . Conclusions : Use of commonly available foods led to a 27 % increase in stearic acid ( diet S ) and a 19 % increase in palmitic acid ( diet P ) , on diets S and P respectively , and no significant differences between the two diets in plasma lipoprotein concentrations , platelet aggregation or platelet activation status . Sponsorship : Grant and chocolate donated from Effem Foods , Pty Ltd , Australia",
"In a prospect i ve epidemiologic study of 1001 middle-aged men , we examined the relation between dietary information collected approximately 20 years ago and subsequent mortality from coronary heart disease . The men were initially enrolled in three cohorts : one of men born and living in Irel and , another of those born in Irel and who had emigrated to Boston , and the third of those born in the Boston area of Irish immigrants . There were no differences in mortality from coronary heart disease among the three cohorts . In within- population analyses , those who died of coronary heart disease had higher Keys ( P = 0.06 ) and modified Hegsted ( P = 0.02 ) dietary scores than did those who did not ( a high score indicates a high intake of saturated fatty acids and cholesterol and a relatively low intake of polyunsaturated fatty acids ) . These associations were significant ( P = 0.03 for the Keys and P = 0.04 for the modified Hegsted scores ) after adjustment for other risk factors for coronary heart disease . Fiber intake ( P = 0.04 ) and a vegetable-foods score , which rose with increased intake of fiber , vegetable protein , and starch ( P = 0.02 ) , were lower among those who died from coronary heart disease , though not significantly so after adjustment for other risk factors . A higher Keys score carried an increased risk of coronary heart disease ( relative risk , 1.60 ) , and a higher fiber intake carried a decreased risk ( relative risk , 0.57 ) . Overall , these results tend to support the hypothesis that diet is related , albeit weakly , to the development of coronary heart disease",
"Despite a high content of saturated fat , evidence from observational studies indicates that the consumption of dairy products may have a neutral effect or may be inversely associated with the risk of CVD . We aim ed to examine whether milk minerals modify the effect of saturated fat on serum lipid profile . We present data from two studies . Study I had a r and omised , blinded , parallel design ( n 24 pigs ) with a 10 d adaptation period during which a high-fat diet was fed to the pigs and a 14 d intervention period during which the same diet either enriched with milk minerals ( MM group ) or placebo ( control group ) was fed to the pigs . Study II had a r and omised cross-over design ( n 9 men ) where the subjects were fed either a high-fat diet enriched with milk minerals ( MM period ) or a regular diet ( control period ) . In both the studies , blood variables were measured before and after the intervention and faecal and urine sample s were collected at the end of the dietary periods . The increase in plasma total cholesterol and LDL-cholesterol concentrations but not in HDL-cholesterol concentration was markedly lowered by milk minerals in both the studies . In the animal study , baseline adjusted total cholesterol and LDL-cholesterol concentrations in the MM group were 11 % ( P = 0.004 ) and 13 % ( P = 0.03 ) lower compared with those in the control group after the intervention . Similarly in the human study , baseline adjusted total cholesterol and LDL-cholesterol concentrations were 6 % ( P = 0.002 ) and 9 % ( P = 0.03 ) lower after the MM period compared with those in the control period . HDL-cholesterol concentration was not lowered by milk minerals . These short-term studies indicate that the addition of milk minerals to a high-fat diet to some extent attenuates the increase in total cholesterol and LDL-cholesterol concentrations , without affecting HDL-cholesterol concentration",
"The effect of dietary intake of high palmitic acid levels in combination with other fatty acids in normal subjects was assessed . Palmitic acid ( 10 % of energy ) was fed in conjunction with decreasing levels of linoleic acid to determine if a threshold level of linoleic acid prevented palmitic acid from being hypercholesterolaemic . Healthy subjects received each of the diet treatments for 21 days , followed by washout periods of 7 days . In a second experiment , the effect of exchanging palmitic acid for trans fatty acids on plasma lipoprotein cholesterol levels and on rates for endogenous synthesis of cholesterol in normal subjects was investigated . Diet treatment lasted for 30 days . On day 30 of each diet treatment , a priming dose of deuterium was consumed , followed by a subsequent blood sample at 24 h. Blood cholesterol fractions were isolated and analysed by isotope ratio mass spectrometry to measure cholesterol fractional synthetic rates . In the first experiment , total plasma cholesterol levels increased as the percentage of linoleic acid decreased . The data indicated that high levels of palmitic acid were not hypercholesterolaemic if intake of linoleic acid was greater than 4.5 % of energy . When the diet contained trans fatty acids plasma total and low-density lipoprotein-cholesterol increased and cholesterol synthesis increased with a decrease in high-density lipoprotein-cholesterol",
"Background Dietary trans-rich and interesterified fats were compared to an unmodified saturated fat for their relative impact on blood lipids and plasma glucose . Each fat had melting characteristics , plasticity and solids fat content suitable for use as hardstock in margarine and other solid fat formulations . Methods Thirty human volunteers were fed complete , whole food diets during 4 wk periods , where total fat ( ~31 % daily energy , > 70 % from the test fats ) and fatty acid composition were tightly controlled . A crossover design was used with 3 r and omly-assigned diet rotations and repeated- measures analysis . One test fat rotation was based on palm olein ( POL ) and provided 12.0 percent of energy ( % en ) as palmitic acid ( 16:0 ) ; a second contained trans-rich partially hydrogenated soybean oil ( PHSO ) and provided 3.2 % en as trans fatty acids plus 6.5 % en as 16:0 , while the third used an interesterified fat ( IE ) and provided 12.5 % en as stearic acid ( 18:0 ) . After 4 wk the plasma lipoproteins , fatty acid profile , as well as fasting glucose and insulin were assessed . In addition , after 2 wk into each period an 8 h postpr and ial challenge was initiated in a subset of 19 subjects who consumed a meal containing 53 g of test fat . Results After 4 wk , both PHSO and IE fats significantly elevated both the LDL/HDL ratio and fasting blood glucose , the latter almost 20 % in the IE group relative to POL . Fasting 4 wk insulin was 10 % lower after PHSO ( p > 0.05 ) and 22 % lower after IE ( p the glucose incremental area under the curve ( IAUC ) following the IE meal was 40 % greater than after either other meal ( p depressed insulin and C-peptide ( p PHSO and IE fats altered the metabolism of lipoproteins and glucose relative to an unmodified saturated fat when fed to humans under identical circumstances",
"Objective : To investigate the association between dietary patterns and risk of a first nonfatal acute myocardial infa rct ion ( MI ) in Costa Rican adults . Design : Population -based case – control study .Subjects : A total of 496 incident MI cases and 518 population -based r and omly selected controls matched to the cases by age ( ±5 years ) , gender , and county of residence . Subjects were interviewed with a vali date d food frequency question naire . Dietary patterns were identified by factor analysis . Odds ratios ( OR ) and 95 % confidence intervals ( CI ) were obtained using multivariate conditional logistic regression adjusted for several recognized risk factors for MI . Results : Two diet patterns were identified , ‘ vegetable ’ characterized by increased intake of vegetables and fruits , and ‘ staple ’ , characterized by an increased use of palm oil for cooking , and intake of refined grains ( mostly white rice and white bread ) , legumes , coffee , added sugar , and red meat . Compared to the lowest quintile of the staple diet pattern , the highest quintile was associated with an increased risk of MI ( OR : 3.70 , 95 % CI : 2.30–5.97 ) . Adjusting for potential confounders did not change the results ( OR : 3.53 , 95 % CI : 1.98–6.31 ) . Consistently , an increasing staple pattern score was associated with lower HDL cholesterol ( P for trend and α-linolenic acid in adipose tissue ( P for trend with MI . Conclusions : The staple dietary pattern of Costa Rican adults is associated with low plasma HDL cholesterol , low α-linolenic acid in adipose tissue , and increased risk of MI.Sponsorship : This study was funded by grants HL 60692 and HL 49086 from the US National Institutes of Health",
"The effects of palmitic and stearic acid-enriched diets on serum lipids , lipoproteins , apolipoproteins ( apo ) A-I and B , and plasma cholesteryl ester transfer protein ( CETP ) activity were examined in 12 healthy young women . Subjects followed the two experimental diets for 4 weeks according to a r and omized crossover design . Both experimental diet periods were preceded by consumption of a baseline diet for 2 weeks . The diets provided 37 % of total energy intake ( E% ) as fat , and differed only with respect to fatty acid composition . There was a substitution of 5E% of palmitic acid or stearic acid in the experimental diets for 5E% of monounsaturated fatty acids in the baseline diet . After the palmitic acid diet , serum total and high-density lipoprotein ( HDL ) cholesterol and apo A-I concentrations were higher ( 8 % , P = .015 , 9 % , P = .040 , and 11%,P = .011 , respectively ) and mean serum low-density lipoprotein ( LDL ) cholesterol concentration tended to be higher ( 8 % , P = .077 ) as compared with values after the stearic acid diet . Plasma CETP activity increased in the palmitic acid diet as compared with the stearic acid diet ( 12 % , P = .006 ) . In conclusion , palmitic acid and stearic acid-enriched diets had different effects on serum lipids and lipoproteins and also on plasma CETP activity in young healthy women",
"Plasma lipoprotein[a ] ( Lp[a ] ) is associated with atherogenesis and thrombogenesis . We examined how plasma Lp[a ] in healthy young men was affected by fats high in stearic ( C18 ) , palmitic ( C16 ) , and lauric+myristic ( C12 + C14 ) acid ( experiment I , 15 subjects ) , and by fats high in myristic ( C14 ) and palmitic ( C16 ) acid ( experiment II , 12 subjects ) . Strictly controlled isocaloric diets with 36 % of energy from test fats were served in r and om order for 3 weeks separated by wash-out period(s ) . Diets high in C18 gave significantly higher levels of Lp[a ] ( 51(12 - 560 ) mg/L ) than diets high in C16 ( 38(12 - 533 mg/L ) ( P = 0.020 ) and C12 + C14 ( 34(12 - 534 ) mg/L ) ( P = 0.002 ) . These differences were observed in several of the subjects in experiment I. In experiment II we saw no difference in plasma Lp[a ] after diets high in C16 and C14 . Our observations suggest that a fat high in stearic acid might affect Lp[a ] in a different way than fats high in palmitic and myristic+lauric acid . Lp[a ] concentrations were not associate with changes in tissue-plasminogen activator ( t-PA ) activity , factor VII coagualant activity , or plasma LDL cholesterol",
"Little is known about the physiological effects of red palm olein ( RPO ) . The effects of red palm olein and palm olein ( POL ) compared to sunflower oil ( SFO ) , on lipids , haemostatic factors and fibrin network characteristics in hyperfibrinogenaemic volunteers were investigated . Fifty-nine free-living , hyperfibrinogenaemic volunteers participated in this r and omized , controlled , single blind parallel study . After a 4-week run-in , during which subjects received sunflower oil products , they were paired and r and omly assigned to one of three intervention groups receiving products containing 25 g/day ( approximately 12 % of total energy intake ) of either red palm olein , palm olein or sunflower oil for another 4 weeks . Anthropometric measurements , blood sample s and dietary intakes were measured before run-in , and before and after intervention . The differences in changes in total serum cholesterol response between palm olein and red palm olein ( + 0.59 vs. + 0.18 mmol/l ; p=0.053 ) , and between palm olein and sunflower oil ( + 0.59 vs. -0.003 mmol/l ; p low-density lipoprotein cholesterol ( LDLC ) response in the palm olein- and sunflower oil-groups also differed significantly ( + 0.42 vs. -0.11 mmol/l ; p Tissue plasminogen activator antigen ( tPA(ag ) ) decreased significantly in the red palm olein group compared to the palm olein- and sunflower oil-groups . No effects were found in other haemostatic variables . Palm olein and red palm olein had no independent effect on fibrin network characteristics . In conclusion , compared to palm olein , red palm olein had less detrimental effects on the lipid profile and decreased tissue plasminogen activator antigen . Studies in larger groups are advised for confirmation of results , elucidation of mechanisms and effects of nonglyceride constituents of red palm oil ( PO )",
"Background : Many studies have shown that trans fatty acids have unfavorable effects on the serum lipoprotein profile . In general , however , fats were compared with different functional characteristics , which lower the practical applications of the results . Objective : The major aim of this study was to compare the effects of a high-palmitic acid , trans-free semiliquid fat with those of a high-oleic acid , low-trans semiliquid fat on the serum lipoprotein profile of healthy subjects . Subjects and design : Forty-four subjects ( 33 women and 11 men ) consumed , in r and om order , two experimental diets , each for 3 weeks . Diets provided 40 energy percent ( En% ) from fat , while 15 En% was supplied by the experimental fats . At the end of each intervention period , concentrations of serum lipoproteins , C-reactive protein , glucose and insulin were measured . Results : When subjects consumed the high-oleic acid , low-trans semiliquid fat , intakes of stearic acid ( + 1.3 En% ) , oleic acid ( + 2.9 En% ) , α-linolenic acid ( + 0.1 En% ) and trans fatty acids ( + 0.6 En% ) were higher and that of palmitic acid ( −4.2 En% ) lower . Serum concentration of low-density lipoprotein cholesterol decreased by 0.34±0.39 mmol/l ( mean±s.d . ; 95 % confidence interval ( CI ) , −0.46 to −0.23 mmol/l ; P ) and high-density lipoprotein ( HDL ) cholesterol by −0.06±0.17 mmol/l ( 95 % CI , −0.11 to −0.01 mmol/l ; P=0.021 ) . Also , the total to HDL cholesterol ratio was lower ( −0.15±0.34 ; 95 % CI , −0.25 to −0.05 ; P=0.006 ) . Other parameters did not change . Conclusions : A high-oleic acid , low-trans semiliquid fat has a more favorable effect on the serum lipoprotein profile than a trans-free semiliquid fat with comparable functional characteristics , but high in palmitic acid",
"OBJECTIVE Effects of red palm oil on major plasma carotenoids , tocopherol , retinol and serum lipids were evaluated when used in Chinese diet . METHODS Red palm oil group ( RPO ) composed of 20 male subjects(aged 18 - 32 ) and soybean oil group ( SBO ) composed of 22 male subjects ( aged 18 - 32 ) . Dietary fat provided about 28 % of total calories , and the test oil accounted for about 60 % of total dietary fat . In the 3 weeks of pretest period , diets were prepared with soybean oil , and then in the next 6 weeks subjects in each group consumed the diet prepared by test oil . RESULTS Plasma alpha-carotene , beta-carotene and lycopene concentration of RPO group significantly increased at the time of interim ( 21 days ) and of the end ( 42 days ) ( P alpha-tocopherol concentration significantly increased at the time of the end ( 42 days ) in this study . Though Chinese plasma retinol level was relatively low when compared with that of Westerners , red palm oil diet showed no significant effect on adult Chinese plasma retinol level . Serum concentration of total cholesterol , triglyceride , high density lipoprotein cholesterol , apolipoprotein AI and apolipoprotein B of all subjects showed no significant changes in RPO group during the study . CONCLUSIONS The data in our study suggest that red palm oil is a good source of carotenoids and vitamin E when used in Chinese diet preparation , and it can significantly increase plasma concentration of alpha-carotene , beta-carotene , lycopene and alpha-tocopherol",
"We previously found no difference in healthy young adults ' plasma cholesterols between palmolein and olive oil as the major dietary lipid , although the former is high in palmitic acid ( 16:0 ) but the latter in oleic acid ( 18:1 cis ) . In the experiment reported here we compared the effects of palmolein against another monounsaturated oil , highly oleic sunflower oil ( HOSO ) , on plasma cholesterol in both young and middle-aged healthy adults . The test oils were provided as frying oil of potato crisps ( 150 g/day in men ; 100 g/day in women ) against low-fat background diets in free-living motivated volunteers . The design was a r and omised double-blind 4-week/3-week crossover trial . Compliance was monitored with continuous dietary diaries and by measuring ( fasting ) plasma lipid fatty-acid pattern . Plasma lipids and vitamin-E compounds were measured at the start and twice at the end of each test period . In combined young plus older subjects ( n = 42 ) mean plasma total and low-density-lipoprotein cholesterol ( LDL-c ) values were both 7 % ( significantly ) lower on HOSO than on palmolein , but because high-density-lipoprotein cholesterol ( HDL-c ) was also 5 % lower , the LDL-c/HDL-c ratio was only 3 % lower on HOSO than on palmolein . The difference between the present results with HOSO and previous results with olive oil both compared against palmolein suggest that olive oil is associated with higher plasma cholesterols than other monounsaturated oils . In both the young and older subgroup , LDL-c was lower on HOSO but because HDL-c moved down too in the young subgroup , the LDL-c/HDL-c ratio was lower on HOSO only in the older subjects . Palmolein has an unusual pattern of E vitamins , with a high content of tocotrienols , notably the gamma-isomer . Unlike alpha-tocopherol however , there was no sign of these tocotrienols in subjects ' plasmas",
"Palmitoleic acid is a minor monounsaturated fatty acid in the human diet and in blood plasma . Because macadamia oil is at least one potentially large source of palmitoleic acid , we tested its effect on plasma lipid levels against two other dietary fatty acids , oleic acid and palmitic acid . The dietary adjustments , through the use of supplements , provided comparisons of the three test fatty acids in which palmitoleic could be judged as behaving either like a saturated or a monounsaturated acid . Thirty-four hypercholesterolemic men ate the three test diets in r and om order in 3-week periods . Plasma total cholesterol and low density lipoprotein ( LDL ) cholesterol concentrations were similar with palmitic and palmitoleic acids and significantly higher than with oleic acid . High density lipoprotein ( HDL ) cholesterol was significantly lower with palmitoleic than with palmitic acid . The study confirms that , at least in hypercholesterolemic men , a modest increase in palmitic acid ( + 4 % en ) raises LDL cholesterol relative to oleic acid ( + 3 % en ) , even when dietary cholesterol is low ( acid ( + 4 % en ) behaves like a saturated and not a monounsaturated fatty acid in its effect on LDL cholesterol",
"Thirty-eight male volunteers participated in a double-blind cross-over trial evaluating the effect of replacing the usual sources of saturated fat in the Dutch diet ( animal fats and hydrogenated oils ) by palm oil , which is virtually free of cholesterol and trans-fatty acids , on serum lipids , lipoproteins and apolipoproteins . Maximum ( about 70 % ) replacement had no significant effect on serum total cholesterol or most lipoprotein fractions , but result ed in an 11 % increase in serum high-density-lipoprotein (HDL)2-cholesterol relative to the control ( P2 = 0.01 ) . The palm-oil diet also caused an 8 % decrease in low-density-lipoprotein (LDL):HDL2 + HDL3-cholesterol ratio ( P2 = 0.02 ) as well as a 9 % decrease in triacylglycerols in the low-density-lipoprotein fractions ( P2 = 0.01 ) . Palm oil consumption result ed in a 4 % increase in serum apolipoprotein AI ( P2 = 0.008 ) and a 4 % decrease in apolipoprotein B ( P2 = 0.01 ) relative to the control diet ; the B : AI apolipoprotein ratio was decreased by 8 % ( P2 lipoprotein E phenotypes of the volunteers . Although the observed differences were relatively modest , the present study , nonetheless , indicates that dietary palm oil , when replacing a major part of the normal fat content in a Dutch diet , may slightly reduce the lipoprotein- and apolipoprotein-associated cardiovascular risk profiles",
"OBJECTIVE To compare the effects on lipid levels , glycemic control , and diurnal blood pressure of two diets rich in one of the two quantitatively most important saturated fatty acids , stearic and palmitic acid , with a carbohydrate-rich diet in NIDDM patients . RESEARCH DESIGN AND METHODS A total of 15 NIDDM patients participated in a r and omized crossover study with three 3-week diet interventions separated by 2-week washout periods . Patients started with a diet rich in stearic acid ( 44 E% [ percent of total energy ] fat [ 13 E% stearic acid ] , 40 E% carbohydrate , 15 E% protein ) , palmitic acid ( 45 E% fat [ 16 E% palmitic acid ] , 40 E% carbohydrate , 15 E% protein ) , or carbohydrate ( 29 E% fat , 51 E% carbohydrate , and 18 E% protein ) , then were shifted to the other two diets in a r and omized block design . At the start and end of each intervention period , fasting blood sample s were drawn for analysis of lipids and blood glucose . In addition , diurnal blood pressure was measured . RESULTS At the end of the 3-week interventions , total cholesterol was significantly higher after the palmitic acid-rich diet than after the stearic acid-rich or carbohydrate-rich diets ( 5.3 ± 1.3 vs. 5.0 ± 1.2 and 4.9 ± 1.2 mmol/l , respectively ; P = 0.03 ) . No significant differences in triglyceride , LDL , or HDL cholesterol levels were seen after the three intervention diets . No difference in effects between the diet periods were seen for fructosamine , HbA1c , fasting blood glucose , or diurnal blood pressure . CONCLUSIONS For the first time , it has been demonstrated that a diet rich in palmitic acid was not as effective in lowering cholesterol levels as carbohydrate-rich and stearic acid-rich diets in NIDDM patients . No deleterious effects were seen on diurnal blood pressure , triglyceride levels , and glycemic control . Development of foods containing stearic acid rather than the more atherogenic saturated fatty acids may allow a wider choice of acceptable foods to NIDDM patients",
"OBJECTIVE To evaluate the relation between intake and adipose tissue composition of fatty acids and acute myocardial infa rct ion in Portuguese men . DESIGN Case-control study . Diet was assessed using a semiquantitative food frequency question naire . In 49 case and 49 control subjects , adipose tissue composition was assessed by gas-liquid chromatography . SUBJECTS/ SETTING Population -based ; subjects were 297 consecutively admitted cases of first acute myocardial infa rct ion in a tertiary care hospital who were aged > or=40 years . Three hundred ten community controls were selected by r and om-digit dialing . MAIN OUTCOME MEASURE Odds ratio ( OR ) . STATISTICAL ANALYSIS PERFORMED Logistic regression , adjusting for age , education , family history of acute myocardial infa rct ion , smoking , physical activity , body mass index , and energy intake . RESULTS Total fat intake ( OR 0.45 , fourth quartile , P=0.02 ) , lauric acid ( OR 0.44 , fourth quartile , P=0.02 ) , palmitic acid ( OR 0.58 , fourth quartile , P=0.03 ) , and oleic acid ( OR 0.42 , fourth quartile , P=0.03 ) were inversely associated with acute myocardial infa rct ion . No significant effects were found for the remaining fatty acids . In the adipose tissue composition data , the adjusted risk estimates of acute myocardial infa rct ion for the highest vs the lowest tertile were 0.16 , 0.14 , and 0.04 for lauric , oleic , and trans-fatty acids , respectively . A significant direct association was found for palmitic and linoleic acids ( adjusted ORs for the highest tertile were 9.02 and 3.63 , respectively ) . CONCLUSIONS Low intake of total fat and lauric acid from dairy products was associated with acute myocardial infa rct ion . The association of polyunsaturated fatty acids with risk of acute myocardial infa rct ion was nonsignificant after adjustment for energy intake and confounders . Recommendations on fatty acid intake should aim for both an upper and lower limit",
"We studied the metabolic effects of stearic acid ( 18:0 ) on plasma lipoprotein levels in 11 subjects during three dietary periods of three weeks each . The three liquid-formula diets , which were used in r and om order , were high in palmitic acid ( 16:0 ) , stearic acid , and oleic acid ( 18:1 ) , respectively . Caloric intakes were the same during the three periods . As compared with the values observed when the subjects were on the high-palmitic-acid diet , plasma total cholesterol decreased by an average of 14 percent during consumption of the high-stearic-acid diet ( P less than 0.005 ) and by 10 percent during consumption of the high-oleic-acid diet ( P less than 0.02 ) . Low-density lipoprotein cholesterol levels fell by 21 percent in subjects on the high-stearic-acid diet ( P less than 0.005 ) and by 15 percent in subjects on the high-oleic-acid diet ( P less than 0.005 ) . No significant differences were observed in the plasma levels of triglycerides or high-density lipoprotein cholesterol among the three diets . Measurements of the intestinal absorption of palmitic , stearic , and oleic acids revealed essentially complete absorption of each during the three dietary periods . The oleic acid content of plasma triglycerides and cholesteryl esters increased significantly during the high-stearic-acid period , suggesting that stearic acid is rapidly converted to oleic acid . We conclude that stearic acid appears to be as effective as oleic acid in lowering plasma cholesterol levels when either replaces palmitic acid in the diet",
"The effects of a diet containing soybean oil ( SBO ) , rice bran oil ( RBO ) , palm oil ( PO ) or a RBO/PO ( 3:1 ) mixture on the composition and oxidation of small dense low-density lipoproteins ( sdLDL ) in 16 hypercholesterolaemic women were investigated . During the 8-week control period , participants consumed a free-choice weight-maintaining diet comprising carbohydrate ( 55 % energy ) , protein ( 15 % energy ) and fat ( 30 % energy ) with During each 10-week study period , participants consumed this same diet but with the addition of one of the three test oils or the RBO/PO mixture . Total cholesterol and low-density lipoprotein (LDL)-cholesterol levels were significantly reduced during SBO , RBO and RBO/PO consumption , while high-density lipoprotein cholesterol was significantly decreased by SBO consumption . There was a significant reduction in sdLDL-cholesterol levels only after using SBO and it tended to be reduced during RBO/PO consumption , whereas it was significantly increased following PO consumption . The sdLDL oxidation lag time was significantly increased during PO , RBO/PO and RBO consumption , but significantly reduced following SBO . The results for the RBO/PO mixture suggest that this oil mixture might further reduce the risk of atherosclerosis",
"Summary . Partial hydrogenation of oil results in fats containing unusual isomeric fatty acids characterized by cis and trans configurations . Hydrogenated fats containing trans fatty acids increase plasma total cholesterol ( TC ) and LDL-cholesterol while depressing HDL-cholesterol levels . Identifying the content of trans fatty acids by food labeling is overshadowed by a reluctance of health authorities to label saturates and trans fatty acids separately . Thus , it is pertinent to compare the effects of trans to saturated fatty acids using stable isotope methodology to establish if the mechanism of increase in TC and LDL-cholesterol is due to the increase in the rate of endogenous synthesis of cholesterol . Ten healthy normocholesterolemic female subjects consumed each of two diets containing approximately 30 % of energy as fat for a fourweek period . One diet was high in palmitic acid ( 10.6 % of energy ) from palm olein and the other diet exchanged 5.6 % of energy as partially hydrogenated fat for palmitic acid . This fat blend result ed in monounsaturated fatty acids decreasing by 4.9 % and polyunsaturated fats increasing by 2.7 % . The hydrogenated fat diet treatment provided 3.1 % of energy as elaidic acid . For each dietary treatment , the fractional synthesis rates for cholesterol were measured using deuterium-labeling procedures and blood sample s were obtained for blood lipid and lipoprotein measurements . Subjects exhibited a higher total cholesterol and LDL-cholesterol level when consuming the diet containing trans fatty acids while also depressing the HDL-cholesterol level . Consuming the partially hydrogenated fat diet treatment increased the fractional synthesis rate of free cholesterol . Consumption of hydrogenated fats containing trans fatty acids in comparison to a mixtur e of palmitic and oleic acids increase plasma cholesterol levels apparently by increasing endogenous synthesis of cholesterol"
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41174f9c-06ff-11f0-808a-c43d1ab1c353
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Although several studies have evaluated the inhibitory effect of probiotics on halitosis , findings are inconsistent . This systematic review and meta- analysis of r and omized clinical trials ( RCT ) was conducted to summarize the evidence on the effect of probiotics on halitosis . RCT on any type of probiotic treatment with at least 2-week duration were identified through electronic data bases ( PubMed , EMBASE , Web of Science , and the Cochrane Central Register of Controlled Trials ) and h and search ed between 1946 and January 17 , 2017 . Primary outcomes were organoleptic ( OLT ) scores and volatile sulfur compounds ( VSC ) . St and ardized mean difference ( SMD ) and 95 % confidence interval ( CI ) were calculated . Meta- analysis was conducted to synthesize the evidence . Of the 153 articles identified , three met the inclusion criteria . Meta- analysis revealed that OLT scores ( SMD = − 1.93 , 95 % CI − 2.85 to − 1.02 , P subjects who received probiotics than in placebo groups , but no significant difference was observed at the VSC concentration ( SMD = − 0.02 , 95 % CI − 2.12 to 2.07 , P = 0.98 ) . Current evidence is supportive of recommending probiotics for the management of halitosis . Based on this review , transient ( average of 2 weeks ) dosing with probiotics ( mainly Lactobacillus strains ) has a moderate effect on halitosis regarding OLT scores , but we could not confirm the effects of probiotics on the VSC reduction . The available evidence is quantitatively and qualitatively insufficient for further recommendations , especially with regard to administration strategies and pretreatment . Future studies should aim for longer follow-up and st and ardized administration methods to prove or refute the effect of probiotics on halitosis
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"PURPOSE The aim of this study was to examine the effect of chlorhexidine disinfection , as a chemical method of oral hygiene practice , and subsequent use of probiotics on halitosis in children . The effects of mechanical and chemical oral hygiene practice methods on the severity of halitosis were also assessed . MATERIAL S AND METHODS 208 children with organoleptic test ( OLT ) scores of 2 or more were r and omly assigned to four groups : A : conventional oral hygiene practice s ( COH ) including toothbrushing and flossing ; B : COH + tongue scraping ( TS ) ; C : COH + TS + chlorhexidine ; D : COH + TS + chlorhexidine + probiotics . OLT was performed at 1-week and 3-month follow-ups . RESULTS A significant and stable number of participants showed major and moderate levels of improvement in OLT scores in group D ( p improvement of OLT scores in group C was also significant ( p the OLT scores were detected in groups A and B through follow-ups ( p > 0.05 ) . CONCLUSION Probiotic therapy following oral disinfection with chlorhexidine may reduce the severity of halitosis over longer periods",
"OBJECTIVE Streptococcus salivarius K12 ( BLIS K12 ) is a probiotic strain strongly antagonistic to the growth of Streptococcus pyogenes , the most important bacterial cause of pharyngeal infections in humans . Shown to colonize the oral cavity and to be safe for human use , BLIS K12 has previously been reported to reduce pharyngo-tonsillitis episodes in children or adults known to have experienced recurrent streptococcal infection . The present study was focussed upon evaluating the role of BLIS K12 in the control of streptococcal disease and acute otitis media in children attending the first year of kindergarten . PATIENTS AND METHODS By r and omization , 222 enrolled children attending the first year of kindergarten were divided into a treated group ( N = 111 ) receiving for 6 months a daily treatment with BLIS K12 ( Bactoblis ® ) and a control group ( N = 111 ) who were monitored as untreated controls . During the 6 months of treatment and 3 months of follow-up , the children were evaluated for treatment tolerance , and for episodes of streptococcal pharyngo-tonsillitis , scarlet fever and acute otitis media . RESULTS During the 6-month trial ( N = 111 per group ) the incidence of streptococcal pharyngo-tonsillitis , scarlet fever and acute otitis media was approximately 16 % , 9 % and 44 % respectively in the treated group and 48 % , 4 % and 80 % in the control group . During the 3-months follow-up ( N = 29 per group ) the corresponding rates of infection were 15 % , 0 % and 12 % in the treated group and 26 % , 6 % and 36 % in the controls . No apparent side effects were detected in the treated group either during treatment or follow-up . All of the enrolled children completed the study . CONCLUSIONS The daily administration of BLIS K12 to children attending their first year of kindergarten was associated with a significant reduction in episodes of streptococcal pharyngitis and acute otitis media . No protection against scarlet fever was detected",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"Objective : Periodontitis is known to have multifactorial etiology , involving interplay between environmental , host and microbial factors . The current treatment approaches are aim ed at reducing the pathogenic microorganisms . Administration of beneficial bacteria ( probiotics ) has emerged as a promising concept in the prevention and treatment of periodontitis . Thus , the aim of the present study is to evaluate the efficacy of the local use of probiotics as an adjunct to scaling and root planing ( SRP ) in the treatment of patients with chronic periodontitis and halitosis . Methods : This is a r and omized , placebo-controlled , double-blinded trial involving 32 systemically healthy chronic periodontitis patients . After SRP , the subjects were r and omly assigned into the test and control groups . Test group ( SRP + probiotics ) received subgingival delivery of probiotics and probiotic mouthwash , and control group ( SRP + placebo ) received subgingival delivery of placebo and placebo mouthwash for 15 days . Plaque index ( PI ) , modified gingival index ( MGI ) , and bleeding index ( BI ) were assessed at baseline , 1 and 3 months thereafter , whereas probing depth ( PD ) and clinical attachment level were assessed at baseline and after 3 months . Microbial assessment using N-benzoyl-DL-arginine-naphthylamide ( BANA ) and halitosis assessment using organoleptic scores ( ORG ) was done at baseline , 1 and 3 months . Findings : All the clinical and microbiological parameters were significantly reduced in both groups at the end of the study . Inter-group comparison of PD reduction ( PDR ) and clinical attachment gain ( CAG ) revealed no statistical significance except for PDR in moderate pockets for the test group . Test group has shown statistically significant improvement in PI , MGI , and BI at 3 months compared to control group . Inter-group comparison revealed a significant reduction in BANA in test group at 1 month . ORG were significantly reduced in test group when compared to control group . Conclusion : Within the limitations of the study , the present investigation showed that the adjunctive use of probiotics offers clinical benefit in terms of pocket depth reduction in moderate pockets and reduced oral malodor parameters",
"The aim of this r and omized clinical trial was to evaluate whether a recently described multi-sensor approach called BIONOTE ® is accurate enough to verify the efficacy of treatment of patients with halitosis . A treatment with Lactobacillus brevis (CD2)–containing lozenges , compared with placebo was tested . The BIONOTE ® was compared with traditional techniques used to detect halitosis : OralChroma ™ and two calibrated odor judges enrolled for the organoleptic assessment s. Twenty patients ( 10 treated and 10 placebo ) , suffering from active phase halitosis were included in the study . Treatment consisted of Lactobacillus brevis (CD2)—containing lozenges or placebo , 4 tablets/day for 14 days . t0 was before the beginning of the study ; t1 was day 7 and t2 was day 14 . The effectiveness of treatment was assessed through : ( 1 ) Rosenberg score ; ( 2 ) Winkel tongue coating index ( WTCI ) anterior and posterior ; ( 2 ) OralChroma ™ ; ( 3 ) the new developed multi-sensor approach , called BIONOTE ® ( test technique ) . Only the WTCI anterior revealed statistically significant changes between t0 and t2 data ( p = 0.014 ) in the treated group . Except for the WTCI anterior , all diagnostic methods revealed the lack of effectiveness for halitosis of a 14-days treatment with Lactobacillus brevis (CD2)–containing lozenges . The BIONOTE ® multisensor system seems accurate in addition to OralChroma ™ to assess the initial condition of halitosis and its mitigation during treatment",
"BACKGROUND Morning breath odor is an often-encountered complaint . This double-blind , crossover , r and omized study aim ed to examine the bad breath-inhibiting effect of 3 commercially available mouthrinses on morning halitosis during an experimental period of 12 days without mechanical plaque control . METHODS Twelve medical students with a healthy periodontium refrained from all means of mechanical plaque control during 3 experimental periods of 12 days ( with intervening washout periods of at least 3 weeks ) . A professional oral cleaning preceded each period . During each experimental period , as the only oral hygiene measure allowed , the students rinsed twice a day with one of the following formulations in a r and omized order : CHX-Alc ( a 0.2 % chlorhexidine [ CHX ] solution ) ; CHX-NaF ( CHX 0.12 % plus sodium fluoride 0.05 % ) ; or CHX-CPC-Zn ( CHX 0.05 % plus cetylpyridinium chloride 0.05 % plus zinc lactate 0.14 % ) . After 12 days , morning breath was scored via volatile sulfur compound ( VSC ) level measurements of the mouth air and organoleptic ratings of the mouth air , the expired air , and a scraping of the tongue coating . At the 12-day visit , a question naire ( subjective ratings ) was completed and sample s taken from both the tongue coating and the saliva for anaerobic and aerobic culturing and vitality staining . The de novo supragingival plaque formation was also recorded . All parameters were correlated with the baseline registration s. RESULTS Although oral hygiene during the 3 experimental periods was limited to oral rinses , bad breath parameters systematic ally improved , with the exception of a slight increase in VSC levels while using CHX-Alc , a finding which was associated with the direct influence of the CHX on the sulfide monitor . The oral microbial load after the use of CHX-NaF remained unchanged , while for the CHX-Alc and CHX-CPC-Zn , significant reductions in both aerobic and anaerobic colony forming units (CFU)/ml were noticed in comparison with baseline data for both tongue coating and saliva sample s. The composition of microflora , on the other h and , did not reveal significant changes . The supragingival plaque formation was inhibited , in descending order , by CHX-Alc , CHX-CPC-Zn , and CHX-NaF. The subjective scores for the rinses indicated a higher appreciation for CHX-CPC-Alc and CHX-NaF because of a better taste and fewer side effects . CONCLUSIONS The results of this study demonstrate that morning halitosis can be successfully reduced via daily use of mouthrinses . CHX-Alc and CHX-CPC-Zn mouthrinses result in a significant reduction of the microbial load of tongue and saliva",
"OBJECTIVES Halitosis is a result of overactivity of Gram-negative bacteria for which protein amino acids are the major source of energy . Therefore , statistical correlation between concentrations of volatile sulphur compounds ( VSCs ) and low-molecular-weight amines should be expected . MATERIAL S AND METHODS Eighty-four patients suffering from halitosis and 40 healthy volunteers aged 20 - 62 years ( average 39.7 ) participated in the study . In all subjects low-molecular-weight amines were evaluated by the ninhydrin method . Patients with halitosis were r and omized into treatment groups . Zinc tablets , tablets and mouthwash containing chlorhexidine or lyophilized lactic acid-forming bacteria were used . RESULTS Analysis showed that the level of amines was highest in subjects with halitosis ( 0.39 , s.d . + /- 0.06 , P VSC measurement and organoleptic scores ( P Reduction of amine levels after treatment was statistically significant ( P amine levels began to increase ( 0.37 , s.d . + /- 0.05 ) . The amine levels in healthy controls were lower ( 0.29 , s.d . + /- 0.07 ) and remained at a stable level . CONCLUSION The salivary amine levels significantly correlated with VSC levels and organoleptic scores . Therefore , the ninhydrin method of detecting salivary amines may be an alternative or additional method of diagnosing halitosis . This method may also be used to evaluate treatment efficacy",
"Abstract Objective . To evaluate the effect of chewing gums containing probiotic bacteria on oral malodour . The None hypothesis was that no difference would be displayed compared with placebo gums . Material s and methods . Twenty-five healthy young adults with self-reported malodorous morning breath completed this r and omized double-blind placebo-controlled cross-over trial . The design included run-in and wash-out periods interspersed by two intervention periods of 14 days each . The subjects were instructed to chew one gum in the morning and one in the evening containing either two strains of probiotic lactobacilli ( L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 ) or placebo . The outcome measures were ( i ) organoleptic scores ( 0–5 ) by a certified test panel , ( ii ) concentration of volatile sulphur compounds ( VSC ) measured with a Halimeter and ( iii ) concentration of VSC after a cysteine rinse . Registration s were made at baseline and after each intervention period . Differences between the groups were assessed by non-parametric paired statistics and chi-square test . Results . The median organoleptic score was similar ( score 2 ) in both groups at baseline . After 14 days of treatment , the organoleptic scores were significantly lower in the probiotic group compared with the placebo group ( p the VSC levels displayed no significant differences between the groups , either before or after rinsing with L-cysteine . No adverse effects were registered . Conclusion . The results demonstrated that probiotic chewing gums may have some beneficial effect on oral malodour assessed by organoleptic scores . The results indicate that the probiotic gum may affect bacteria that produce malodourous compounds other than VSCs",
"OBJECTIVE This study evaluated the effect of probiotic intervention using lactobacilli on oral malodor . STUDY DESIGN We conducted a 14-day , double-blind , placebo-controlled , r and omized crossover trial of tablets containing Lactobacillus salivarius WB21 ( 2.0 × 10(9 ) colony-forming units per day ) or placebo taken orally by patients with oral malodor . RESULTS Organoleptic test scores significantly decreased in both the probiotic and placebo periods compared with the respective baseline scores ( P the concentration of volatile sulfur compounds ( VSCs ) ( P = .019 ) and the average probing pocket depth ( P = .001 ) decreased significantly in the probiotic period compared with the placebo period . Bacterial quantitative analysis found significantly lower levels of ubiquitous bacteria ( P = .003 ) and Fusobacterium nucleatum ( P = .020 ) in the probiotic period . CONCLUSIONS These results indicated that daily oral consumption of tablets containing probiotic lactobacilli could help to control oral malodor and malodor-related factors ",
"OBJECTIVE The objective of this study was to evaluate whether oral administration of lactobacilli alters the degree of halitosis and clinical conditions associated with halitosis . STUDY DESIGN Twenty patients with genuine halitosis were given 2.0 x 10(9)Lactobacillus salivarius WB21 and xylitol in tablet form daily . Oral malodor and clinical parameters were evaluated at the same time of day for each patient after 2 and 4 weeks . RESULTS All 20 patients were positive for L. salivarius DNA in their saliva at 2 weeks , although 12 patients were negative for this organism at baseline . Oral malodor parameters significantly decreased at 2 weeks in the subjects with physiologic halitosis . The scores of an organoleptic test and bleeding on probing significantly decreased at 4 weeks in the subjects with oral pathologic halitosis . CONCLUSIONS Oral administration of probiotic lactobacilli primarily improved physiologic halitosis and also showed beneficial effects on bleeding on probing from the periodontal pocket"
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41174fd8-06ff-11f0-808a-c43d1ab1c353
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Background Several studies have evaluated the effect of inositol supplementation on lipid profiles among population with metabolic diseases ; however , the findings are controversial . This review of r and omized controlled trials ( RCTs ) was performed to summarize the evidence of the effects of inositol supplementation on lipid profiles among population with metabolic diseases . Methods Relevant RCTs studies were search ed in Cochrane Library , EMBASE , MEDLINE , and Web of Science until October 2017 . Two research ers assessed study eligibility , extracted data , and evaluated risk of bias of included primary studies , independently . To check for the heterogeneity among included studies Q-test and I2 statistics were used . Data were pooled by using the r and om-effect model and st and ardized mean difference ( SMD ) was considered as summary of the effect size . Results Overall , 14 RCTs were included into meta- analysis . Pooled results showed that inositol supplementation among patients with metabolic diseases significantly decreased triglycerides ( SMD − 1.24 ; 95 % CI , − 1.84 , − 0.64 ; P ( SMD − 1.09 ; 95 % CI , − 1.83 , − 0.55 ; P 0.001 ) , and LDL-cholesterol levels ( SMD − 1.31 ; 95 % CI , − 2.23 , − 0.39 ; P = 0.005 ) . There was no effect of inositol supplementation on HDL-cholesterol levels ( SMD 0.20 ; 95 % CI , − 0.27 , 0.67 ; P = 0.40 ) . Conclusions Inositol supplementation may result in reduction in triglycerides , total- and LDL-cholesterol levels , but did not affect HDL-cholesterol levels among patients with metabolic diseases . Additional prospect i ve studies regarding the effect of inositol supplementation on lipid profiles in patients with metabolic diseases are necessary
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"Objective : To assess the effects of soybean-derived pinitol on glycaemic control and cardiovascular risk factors in Korean patients with type II diabetes mellitus . Design : R and omized , double-blind , placebo-controlled , parallel-group trial . Setting : Pusan Paik Hospital , Pusan , Republic of Korea . Interventions : A total of 30 patients with type II diabetes received an oral dose of 600 mg soybean-derived pinitol or placebo twice daily for 13 weeks . Results : Pinitol significantly decreased mean fasting plasma glucose , insulin , fructosamine , HbA1c , and the homeostatic model assessment insulin resistance index ( HOMA-IR , P Pinitol significantly decreased total cholesterol , LDL-cholesterol , the LDL/HDL-cholesterol ratio , and systolic and diastolic blood pressure and increased HDL-cholesterol ( P soybean-derived pinitol may be beneficial in reducing cardiovascular risk in Korean type II diabetes . Sponsorship : This study was supported by a grant of the Korea Health 21 R&D Project , Ministry of Health & Welfare , Republic of Korea ( HMP 02-PJ1-PG3 - 22005 - 0011 )",
"OBJECTIVE To determine whether the administration of D-chiro-inositol , a putative insulin-sensitizing drug , would affect the concentration of circulating insulin , the levels of serum and rogens , and the frequency of ovulation in lean women with the polycystic ovary syndrome . METHODS In 20 lean women ( body mass index , 20.0 to 24.4 kg/m 2 ) who had the polycystic ovary syndrome , treatment was initiated with either 600 mg of D-chiro-inositol or placebo orally once daily for 6 to 8 weeks . We performed oral glucose tolerance tests and measured serum sex steroids before and after therapy . To monitor for ovulation , we determined serum progesterone concentrations weekly . RESULTS In the 10 women given D-chiro-inositol , the mean ( + /- st and ard error ) area under the plasma insulin curve after oral administration of glucose decreased significantly from 8,343 + /- 1,149 mU/mL per min to 5,335 + /- 1,792 mU/mL per min in comparison with no significant change in the placebo group ( P = 0.03 for difference between groups ) . Concomitantly , the serum free testosterone concentration decreased by 73 % from 0.83 + /- 0.11 ng/dL to 0.22 + /- 0.03 ng/dL , a significant change in comparison with essentially no change in the placebo group ( P = 0.01 ) . Six of the 10 women ( 60 % ) in the D-chiro-inositol group ovulated in comparison with 2 of the 10 women ( 20 % ) in the placebo group ( P = 0.17 ) . Systolic ( P = 0.002 ) and diastolic ( P = 0.001 ) blood pressures , as well as plasma triglyceride concentrations ( P = 0.001 ) , decreased significantly in the D-chiro-inositol group in comparison with the placebo group , in which these variables either increased ( blood pressure ) or decreased minimally ( triglycerides ) . CONCLUSION We conclude that , in lean women with the polycystic ovary syndrome , D-chiro-inositol reduces circulating insulin , decreases serum and rogens , and ameliorates some of the metabolic abnormalities ( increased blood pressure and hypertriglyceridemia ) of syndrome",
"Introduction Statins are at the forefront of strategies to manage dyslipidemia , although they are not always well tolerated . At 6–7 months after the drug was supplied , discontinuation rates averaged 30 % . Alternate agents to statins have been studied . Some nutraceuticals demonstrated an efficacy in reducing cholesterol concentrations . However , there are no data regarding the use of nutraceuticals in elderly dyslipidemic patients . The purpose of this study was to examine the efficacy , safety , and tolerability of a nutraceutical-based protocol in elderly hypercholesterolemic patients previously intolerant to statins . Methods This study was performed as a r and omized , prospect i ve , parallel group , single-blind study . Patients were included in the study if they had high total cholesterolemia , high low-density lipoprotein cholesterol ( LDL-C ) , > 75 years of age , statin-intolerant , and were refusing other pharmaceutical treatments for hypercholesterolemia . At the baseline visit , eligible patients were r and omized to either nutraceutical-combined pill ( containing berberine 500 mg , policosanol 10 mg , red yeast rice 200 mg , folic acid 0.2 mg , coenzyme Q10 2.0 mg , and astaxanthin 0.5 mg ) or placebo , and the first dose was dispensed . The efficacy , safety , and tolerability of the proposed treatment were fully assessed after 3 , 6 , and 12 months of treatment . Results Out of 106 consecutive patients screened , 80 eligible patients were r and omized to receive either nutraceutical-combined pill ( 40 patients ) or placebo ( 40 patients ) . No patients were lost and no deaths occurred during the follow-up . There was a statistically significant reduction in total cholesterolemia ( −20 % ) , LDL-C ( −31 % ) , and insulin resistance ( −10 % ) with nutraceutical treatment . No significant changes were detected for plasma high-density lipoprotein cholesterol ( HDL-C ) . Furthermore , no statistical differences were found between baseline and end- study safety parameters . Medication compliance and tolerability were high . Conclusion In this study the authors have demonstrated that combined nutraceuticals significantly reduce cholesterolemia and achieved acceptable plasma LDL-C levels in elderly hypercholesterolemic patients who were previously statin-intolerant . Combined nutraceuticals is also safe and well tolerated in these patients",
"Background and Aim . Cardiovascular risk is increased in women with menopause and metabolic syndrome . Aim of this study was to test the effect of a new supplement formula , combining cocoa polyphenols , myo-inositol , and soy isoflavones , on some biomarkers of cardiovascular risk in postmenopausal women with metabolic syndrome . Methods and Results . A total of 60 women were enrolled and r and omly assigned ( n = 30 per group ) to receive the supplement ( NRT : 30 mg of cocoa polyphenols , 80 mg of soy isoflavones , and 2 gr of myo-inositol ) , or placebo for 6 months . The study protocol included three visits ( baseline , 6 , and 12 months ) for the evaluation of glucose , triglycerides , and HDL-cholesterol ( HDL-C ) , adiponectin , visfatin , resistin , and bone-specific alkaline phosphatase ( bone-ALP ) . At 6 months , a significant difference between NRT and placebo was found for glucose ( 96 ± 7 versus 108 ± 10 mg/dL ) , triglycerides ( 145 ± 14 versus 165 ± 18 mg/dL ) , visfatin ( 2.8 ± 0.8 versus 3.7 ± 1.1 ng/mL ) , resistin ( 27 ± 7 versus 32 ± 8 µg/L ) , and b-ALP ( 19 ± 7 versus 15 ± 5 µg/mL ) . No difference in HDL-C concentrations nor in adiponectin levels between groups was reported at 6 months . Conclusions . The supplement used in this study improves most of the biomarkers linked to metabolic syndrome . This Trial is registered with NCT01400724",
"BACKGROUND AND AIMS Prospect i ve studies have demonstrated that the risk of death due to ischaemic heart disease is strongly correlated with blood cholesterol ( TC ) levels . Diet is the basic treatment for all dyslipidaemia . If diet alone proves inadequate , supplements can be used to try to reduce cholesterol levels . These substances are indicated in moderate dyslipidaemia , as they are able to induce a moderate reduction in blood cholesterol . The objective of our study was to investigate the effects of a dietary supplement containing Omega-3 , Policosanol , Resveratrol , L-carnitine , Monascus purpureus , Coenzyme Q10 , Vitamin B6 and Vitamin B12 on TC ( primary end point ) and LDL , triglycerides and HDL ( secondary endpoints ) . PATIENTS AND METHODS The study involved 40 men and 40 women recruited from the outpatient section of our Department r and omly assigned to the treatment group ( A ) or the control group ( B ) . RESULTS There was a statistically significant reduction in TC 6 months after the end of treatment in both groups . In Group A , there was also a statistically significant change in HDL , LDL and TG , while in group B , there was no statistically significant change in HDL , LDL or TG . CONCLUSIONS The dietary supplement used in our study , in combination with a balanced diet and physical exercise , was found to induce a significant reduction in TC and LDL-C and an improvement in HDL-C. In contrast , while a balanced diet together with physical exercise but without the dietary supplement produced a significant reduction in TC , it had no significant effect on the other lipid parameters tested",
"BACKGROUND Obese women with polycystic ovary syndrome ( PCOS ) manifest impaired insulin-stimulated release of a d-chiro-inositol-containing inositolphosphoglycan ( DCI-IPG ) insulin mediator during oral glucose tolerance testing ( OGTT ) , which appears to be restored by the administration of metformin . This suggests that either obesity or PCOS is associated with a defect in the coupling of the stimulation of the insulin receptor by insulin to the release of the DCI-IPG mediator . The objective of this study was to compare the release of bioactive DCI-IPG between normal nonobese women and obese PCOS women during stimulation with two different concentrations of insulin when glucose levels are clamped . METHODS We performed a cross-sectional case-control study at the clinical research center of an academic medical center . A two-step euglycemic-hyperinsulinemic clamp was carried out in 8 nonobese normal and 8 obese PCOS women , during which DCI-IPG bioactivity was monitored . RESULTS At baseline , PCOS women were significantly more obese , hyperinsulinemic , and insulin resistant than the controls . During the clamp studies , DCI-IPG bioactivity increased significantly over the first 45 min of the low-insulin step of the clamp in normal nonobese women ( P = 0.046 ) and then decreased to baseline levels ; DCI-IPG increased again after initiation of the high-insulin step ( P = 0.029 ) . Despite higher insulin levels during the clamp in PCOS women , DCI-IPG bioactivity remained flat throughout both insulin steps and was thus significantly lower than in controls during the initial periods of both steps . CONCLUSIONS The coupling between insulin action and the release of the DCI-IPG mediator is selectively impaired in obese PCOS women , which may contribute to the insulin resistance in these women",
"DESIGN AND PURPOSE The supplemental administration of myo-inositol , D-chiro-inositol , folic acid and manganese ( MDFM ) was tested in a prospect i ve , r and omized , double-blind , placebo controlled clinical trial , pilot study , to test the hypothesis that its supplemental administration in the second trimester of pregnancy would improve glucose and glycemic parameters and blood pressure . SUBJECTS AND METHODS Non-obese uniparous healthy pregnant women between 13th and 24th week of pregnancy were divided into two groups : group I , control group with placebo , and the group II , women in treatment with myo-inositol , D-chiro-inositol , folic acid and manganese . The main outcome measures were the comparative analysis of the parameters analyzed at time 0 , after 30 days and 60 days ; secondary outcome measure was the overall analysis of investigated parameters . RESULTS 24 women were allocated to receive MDFM and 24 the placebo . The two groups did not significantly differ for demographic , lipidic and glycemic parameter and blood pressure . After 30 days , significantly lower cholesterol ( p = 0.0001 ) , significantly lower LDL ( p = 0.0013 ) , lower TG ( p lower glycemia ( p = 0.0021 ) were observed all favoring group II . No significant difference was observed for HDL , diastolic and systolic blood pressure . After 60 days , significant difference was observed for cholesterol ( p = 0.0001 ) , LDL ( p = 0.0001 ) , HDL ( p = 0.0001 ) , TG ( p = 0.0001 ) , glycemia ( p = 0.0064 ) , all favoring the group treated with MDFM . No significant differences were observed for systolic ( p = 0.12 ) and diastolic blood pressure ( p = 0.42 ) . When examining for overall differences between the two groups , a significant difference was observed for examined parameters at time 0 and at time 60 ; cholesterol ( p = 0.0001 ) , LDL ( p = 0.0001 ) , HDL ( p = 0.047 ) , TG ( p = 0.0001 ) and glycemia ( p = 0.019 ) were reduced in the MDFM group . A significant reduction was also observed in group II for systolic blood pressure after 60 days of intervention ( p = 0.0092 ) , but not for diastolic blood pressure ( p = 0.29 ) . CONCLUSIONS MDFM administration after 30 days in pregnancy improved glycemic and lipidic parameters , with significant gain after 60 days , without affecting diastolic blood pressure levels",
"AIM To test the hypothesis that myoinositol supplementation will improve insulin sensitivity as measured by markers of insulin resistance such as homeostasis model assessment of insulin resistance and adiponectin in women with gestational diabetes . METHODS The trial was carried out in diet-treated patients with gestational diabetes diagnosed in our department between April 2008 and September 2009 . Subjects were r and omly assigned to receive either myoinositol supplementation ( 4 g daily ) plus folic acid ( 400 μg daily)-the study group-or folic acid only ( 400 μg daily)-the control group . Both groups received the same diet prescription . Homeostasis model assessment of insulin resistance and adiponectin were assayed while fasting at the time of the diagnostic oral glucose tolerance test and after 8 weeks of treatment . RESULTS There were 69 evaluable patients , 24 in the study group and 45 in the control group . Fasting glucose and insulin , and consequently homeostasis model assessment of insulin resistance , decreased in both groups ( 50 % in the study group vs. 29 % in the control group ) , but the decline in the study group was significantly greater than that in the control group ( P = 0.0001 ) . Adiponectin increased in the myoinositol group while it decreased in the control group ( P = 0.009 ) . CONCLUSION Myoinositol improves insulin resistance in patients with gestational diabetes"
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Context Carbohydrate-restricted diets may increase low-density lipoprotein cholesterol and thereby cardiovascular risk . Objective A systematic review and meta-analyses were conducted to compare the effects of very low , low , and moderate carbohydrate , higher fat diets versus high-carbohydrate , low-fat diets on low-density lipoprotein cholesterol and other lipid markers in overweight/obese adults . Data Sources Medline , PubMed , Cochrane Central , and CINAHL Plus were search ed to identify large r and omized controlled trials ( n > 100 ) with duration ≥ 6 months . Data Extraction Eight r and omized controlled trials ( n = 1633 ; 818 carbohydrate-restricted diet , 815 low-fat diet ) were included . Data Analysis Quality assessment and risk of bias , a r and om effects model , and sensitivity and subgroup analyses based on the degree of carbohydrate restriction were performed using Cochrane Review Manager . Results were reported according to the Preferred Reporting Items for Systematic Review s and Meta- Analysis Protocol . Results Carbohydrate-restricted diets showed no significant difference in low-density lipoprotein cholesterol after 6 , 12 , and 24 months . Although an overall pooled analysis statistically favored low-fat diets ( 0.07 mmol/L ; 95 % confidence interval [ CI ] , 0.02 - 0.13 ; P = 0.009 ] , this was clinical ly insignificant . High-density lipoprotein cholesterol and plasma triglycerides at 6 and 12 months favored carbohydrate-restricted diets ( 0.08 mmol/L ; 95%CI , 0.06 - 0.11 ; P with carbohydrate restriction appear superior in improving lipid markers when compared with low-fat diets . Dietary guidelines should consider carbohydrate restriction as an alternative dietary strategy for the prevention/management of dyslipidemia for population s with cardiometabolic risk
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"BACKGROUND & AIMS Data regarding the role of kidney adiposity , its clinical implication s , and its dynamics during weight-loss are sparse . We investigated the effect of long-term weight-loss induced intervention diets on dynamics of renal-sinus-fat , an ectopic fat depot , and % renal-parenchymal-fat , lipid accumulation within the renal parenchyma . METHODS We r and omized 278 participants with abdominal obesity/dyslipidemia to low-fat or Mediterranean/low-carbohydrate diets , with or without exercise . We quantified renal-sinus-fat and % renal-parenchymal-fat by whole body magnetic-resonance-imaging . RESULTS Participants ( age = 48 years ; 89 % men ; body-mass-index = 31 kg/m2 ) had 86 % retention to the trial after 18 months . Both increased renal-sinus-fat and % renal-parenchymal-fat were directly associated with hypertension , and with higher abdominal deep-subcutaneous-adipose-tissue and visceral-adipose-tissue ( p of trend estimated-glomerular-filtration-rate and with higher microalbuminuria and % HbA1C beyond body weight . After 18 months of intervention , overall renal-sinus-fat ( -9 % ; p renal-parenchymal-fat ( -1.7 % ; p = 0.13 vs. baseline ) significantly decreased , and similarly across the intervention groups . Renal-sinus-fat and % renal-parenchymal-fat changes were correlated with weight-loss per-se ( p decreased pancreatic , hepatic and cardiac fats ( p decreased cholesterol/high-density lipoprotein-cholesterol ( HDL-c ) ( β = 0.13 ; p = 0.05 ) , triglycerides/HDL-c ( β = 0.13 ; p = 0.05 ) , insulin ( β = 0.12 ; p = 0.05 ) and gamma glutamyl transpeptidase ( β = 0.24 ; p = 0.001 ) , but not with improved renal function parameters or blood pressure . Decreased intake of sodium was associated with a reduction in % renal-parenchymal-fat , after adjustment for 18 months weight-loss ( β = 0.15 ; p = 0.026 ) and hypertension ( β = 0.14 ; p = 0.04 ) . CONCLUSIONS Renal-sinus-fat and renal-parenchymal-fat are fairly related to weight-loss . Decreased renal-sinus-fat is associated with improved hepatic parameters , independent of changes in weight or hepatic fat , rather than with improved renal function or blood pressure parameters . CLINICAL TRIALS . GOVIDENTIFIER NCT01530724",
"CONTEXT Popular diets , particularly those low in carbohydrates , have challenged current recommendations advising a low-fat , high-carbohydrate diet for weight loss . Potential benefits and risks have not been tested adequately . OBJECTIVE To compare 4 weight-loss diets representing a spectrum of low to high carbohydrate intake for effects on weight loss and related metabolic variables . DESIGN , SETTING , AND PARTICIPANTS Twelve-month r and omized trial conducted in the United States from February 2003 to October 2005 among 311 free-living , overweight/obese ( body mass index , 27 - 40 ) nondiabetic , premenopausal women . INTERVENTION Participants were r and omly assigned to follow the Atkins ( n = 77 ) , Zone ( n = 79 ) , LEARN ( n = 79 ) , or Ornish ( n = 76 ) diets and received weekly instruction for 2 months , then an additional 10-month follow-up . MAIN OUTCOME MEASURES Weight loss at 12 months was the primary outcome . Secondary outcomes included lipid profile ( low-density lipoprotein , high-density lipoprotein , and non-high-density lipoprotein cholesterol , and triglyceride levels ) , percentage of body fat , waist-hip ratio , fasting insulin and glucose levels , and blood pressure . Outcomes were assessed at months 0 , 2 , 6 , and 12 . The Tukey studentized range test was used to adjust for multiple testing . RESULTS Weight loss was greater for women in the Atkins diet group compared with the other diet groups at 12 months , and mean 12-month weight loss was significantly different between the Atkins and Zone diets ( P 12-month weight loss was as follows : Atkins , -4.7 kg ( 95 % confidence interval [ CI ] , -6.3 to -3.1 kg ) , Zone , -1.6 kg ( 95 % CI , -2.8 to -0.4 kg ) , LEARN , -2.6 kg ( -3.8 to -1.3 kg ) , and Ornish , -2.2 kg ( -3.6 to -0.8 kg ) . Weight loss was not statistically different among the Zone , LEARN , and Ornish groups . At 12 months , secondary outcomes for the Atkins group were comparable with or more favorable than the other diet groups . CONCLUSIONS In this study , premenopausal overweight and obese women assigned to follow the Atkins diet , which had the lowest carbohydrate intake , lost more weight at 12 months than women assigned to follow the Zone diet , and had experienced comparable or more favorable metabolic effects than those assigned to the Zone , Ornish , or LEARN diets [ corrected ] While questions remain about long-term effects and mechanisms , a low-carbohydrate , high-protein , high-fat diet may be considered a feasible alternative recommendation for weight loss . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00079573",
"Background / objectives : Small dense low-density lipoprotein ( LDL ) particles and apolipoprotein ( apo ) CIII are risk factors for cardiovascular disease ( CVD ) that can be modulated by diet , but there is little information regarding the effects of dietary saturated fat on their plasma levels . We tested the effects of high vs low saturated fat intake in the context of a high beef protein diet on levels and composition of LDL subclasses and on apoCIII levels in plasma and LDL.Subjects/ methods : Following consumption of a baseline diet ( 50 % carbohydrate ( CHO ) , 13 % protein , 38 % total fat , 15 % saturated fat ) for 3 weeks , 14 healthy men were r and omly assigned to two reduced CHO high beef protein diets ( 31 % CHO , 31 % protein , 38 % fat ) that differed in saturated fat content ( 15 % vs 8 % ) for 3 weeks each in a crossover design . Results : The high saturated fat ( HSF ) diet result ed in higher mass concentrations of buoyant LDL I , medium density LDL II and dense LDL III , but not the very dense LDL IV ; and significant increases in plasma and LDL apoCIII concentration of 9.4 % and 33.5 % , respectively . The saturated fat-induced changes in LDL apoCIII were specifically correlated with changes in apoCIII content of LDL IV . Conclusions : Taken together with previous observations , these findings suggest that , at least in the context of a lower CHO high beef protein diet , HSF intake may increase CVD risk by metabolic processes that involve apoCIII",
"BACKGROUND The effects of a carbohydrate-restricted diet on weight loss and risk factors for atherosclerosis have been incompletely assessed . METHODS We r and omly assigned 132 severely obese subjects ( including 77 blacks and 23 women ) with a mean body-mass index of 43 and a high prevalence of diabetes ( 39 percent ) or the metabolic syndrome ( 43 percent ) to a carbohydrate-restricted ( low-carbohydrate ) diet or a calorie- and fat-restricted ( low-fat ) diet . RESULTS Seventy-nine subjects completed the six-month study . An analysis including all subjects , with the last observation carried forward for those who dropped out , showed that subjects on the low-carbohydrate diet lost more weight than those on the low-fat diet ( mean [ + /-SD ] , -5.8+/-8.6 kg vs. -1.9+/-4.2 kg ; P=0.002 ) and had greater decreases in triglyceride levels ( mean , -20+/-43 percent vs. -4+/-31 percent ; P=0.001 ) , irrespective of the use or nonuse of hypoglycemic or lipid-lowering medications . Insulin sensitivity , measured only in subjects without diabetes , also improved more among subjects on the low-carbohydrate diet ( 6+/-9 percent vs. -3+/-8 percent , P=0.01 ) . The amount of weight lost ( P triglyceride levels and insulin sensitivity . CONCLUSIONS Severely obese subjects with a high prevalence of diabetes or the metabolic syndrome lost more weight during six months on a carbohydrate-restricted diet than on a calorie- and fat-restricted diet , with a relative improvement in insulin sensitivity and triglyceride levels , even after adjustment for the amount of weight lost . This finding should be interpreted with caution , given the small magnitude of overall and between-group differences in weight loss in these markedly obese subjects and the short duration of the study . Future studies evaluating long-term cardiovascular outcomes are needed before a carbohydrate-restricted diet can be endorsed",
"Background — Nuclear magnetic resonance ( NMR ) spectroscopy measures the number and size of lipoprotein particles instead of their cholesterol or triglyceride content , but its clinical utility is uncertain . Methods and Results — Baseline lipoproteins were measured by NMR in 27 673 initially healthy women followed up for incident cardiovascular disease ( n=1015 ) over an 11-year period . After adjustment for nonlipid risk factors , hazard ratios and 95 % confidence intervals for the top versus the bottom quintile of NMR-measured lipoprotein particle concentration ( measured in particles per liter ) were 2.51 ( 1.91 to 3.30 ) for low-density lipoprotein ( LDLNMR ) , 0.91 ( 0.75 to 1.12 ) for high-density lipoprotein ( HDLNMR ) , 1.71 ( 1.38 to 2.12 ) for very low – density lipoprotein ( VLDLNMR ) , and 2.25 ( 1.80 to 2.81 ) for the LDLNMR/HDLNMR ratio . Similarly adjusted results for NMR-measured lipoprotein particle size ( measured in nanometers ) were 0.64 ( 0.52 to 0.79 ) for LDLNMR size , 0.65 ( 0.51 to 0.81 ) for HDLNMR size , and 1.37 ( 1.10 to 1.70 ) for VLDLNMR size . Hazard ratios for NMR measures were comparable but not superior to st and ard lipids ( total cholesterol 2.08 [ 1.63 to 2.67 ] , LDL cholesterol 1.74 [ 1.40 to 2.16 ] , HDL cholesterol 0.52 [ 0.42 to 0.64 ] , triglycerides 2.58 [ 1.95 to 3.41 ] , non-HDL cholesterol 2.52 [ 1.95 to 3.25 ] , total/HDL cholesterol ratio 2.82 [ 2.23 to 3.58 ] ) and apolipoproteins ( B100 2.57 [ 1.98 to 3.33 ] , A-1 0.63 [ 0.52 to 0.77 ] , and B100/A-1 ratio 2.79 [ 2.21 to 3.54 ] ) . Essentially no reclassification improvement was found with the addition of the LDLNMR particle concentration or apolipoprotein B100 to a model that already included the total/HDL cholesterol ratio and nonlipid risk factors ( net reclassification index 0 % and 1.9 % , respectively ) , nor did the addition of either variable result in a statistically significant improvement in the c-index . Conclusions — In this prospect i ve study of healthy women , cardiovascular disease risk prediction associated with lipoprotein profiles evaluated by NMR was comparable but not superior to that of st and ard lipids or apolipoproteins",
"Context In 2003 , the authors reported that severely obese adults lost more weight and had better serum lipid patterns after 6 months of a low-carbohydrate diet rather than a conventional low-fat diet . Contribution After 1 year , these same patients still had more favorable triglyceride and high-density lipoprotein cholesterol levels on the low-carbohydrate diet than on the conventional diet . However , weight loss and the other metabolic parameters were similar in the 2 diet groups . Caution s The effect of the modest improvements in high-density lipoprotein cholesterol and triglyceride levels on the development of diabetes and cardiovascular disease is unknown . The Editors The prevalence of obesity and its associated metabolic abnormalities has increased markedly over the past 2 decades ( 1 , 2 ) . Although guidelines to follow a highcomplex carbohydrate , low-fat , energy-deficient diet to achieve weight loss are generally accepted ( 3 ) , considerable public interest has focused on low-carbohydrate diets ( 4 ) . We recently reported that persons with severe obesity lost more weight and had greater improvements in triglyceride levels , insulin sensitivity , and glycemic control after 6 months of a low-carbohydrate diet as compared with a conventional weight loss diet based on calorie and fat restriction ( 5 ) . However , these findings were preliminary because of the short duration of that study ( 6 ) . A simultaneously published study by Foster and colleagues suggested that persons on a low-carbohydrate diet tended to regain weight by 1 year ( 7 ) . These findings were limited , however , because few participants completed the study and because the study used a self-help approach , which is less effective than direct counseling for maintaining weight loss ( 8) . Foster and colleagues also excluded persons with diabetes , which is highly prevalent in the obese population . During the development of this study , we decided to analyze and report preliminary results at 6 months and final results at 1 year . We thought that the short-term results would be important , given the high-risk nature of our study sample , but that long-term outcomes would provide more information about the sustainability of any diet-related outcomes . We now report our findings 1 year after r and omization to a low-carbohydrate diet versus a low-fat weight loss diet ( conventional diet ) in severely obese adults with a high prevalence of diabetes or the metabolic syndrome . Methods Study Participants The study design has been previously described ( 5 ) . Participants were recruited from the outpatient practice s of the Philadelphia Veterans Affairs Medical Center and included persons 18 years of age and older with a body mass index ( BMI ) of 35 kg/m2 or greater . The exclusion criteria were a serum creatinine level greater than 133 mol/L ( > 1.5 mg/dL ) , hepatic disease , severe life-limiting medical illness , inability to self-monitor glucose levels , or active use of a weight loss program or weight loss medication . Between May 2001 and November 2001 , 132 persons were r and omly assigned to either a low-carbohydrate diet ( n = 64 ) or a conventional diet ( n = 68 ) . The Institutional Review Committee at the Philadelphia Veterans Affairs Medical Center approved the study , and all participants provided written informed consent . Interventions Diet groups met in weekly counseling sessions for 4 weeks , followed by 11 monthly sessions . Participants on the low-carbohydrate diet were instructed only to reduce carbohydrate intake to less than 30 g per day . Participants on the conventional diet were instructed to reduce caloric intake by 500 calories per day , with less than 30 % of calories derived from fat , in accordance with the National Heart , Lung , and Blood Institute guidelines ( 3 ) . Outcome Measures We collected data , including weight ( single calibrated scale , SR Instruments , Inc. , Tonaw and a , New York ) , medical history ( self-reported ) , and blood pressure , at baseline , 6 months , and 1 year . Fasting blood specimens were obtained for glucose , hemoglobin A1c , and serum lipid levels ( Synchron LX20 , Beckman Coulter , Inc. , Fullerton , California ) . Low-density lipoprotein ( LDL ) cholesterol level was calculated by using the Friedewald formula ( 9 ) . We defined the presence of diabetes by a historical fasting blood glucose level greater than 6.94 mmol/L ( > 125 mg/dL ) or use of antidiabetic medications . The metabolic syndrome was considered present if a participant had 3 or more of the following ( 10 ) : central obesity , fasting blood glucose level of 6.11 mmol/L ( 110 mg/dL ) or greater , fasting triglyceride level of 1.70 mmol/L ( 150 mg/dL ) or greater , high-density lipoprotein ( HDL ) cholesterol level less than 1.04 mmol/L ( blood pressure of 130/85 mm Hg or greater , or antihypertensive therapy . We assumed that all participants had central obesity because of the uniform severity of their obesity ( BMI range , 35.0 to 79.4 kg/m2 ) . Serum insulin was measured by radioimmunoassay ( Laboratory Corporation of America Holdings [ LabCorp ] , Burlington , North Carolina ] ) . Insulin resistance in nondiabetic persons was estimated by the quantitative insulin sensitivity check ( QUICK ) index : 1/[(log ( fasting insulin ( U/mL ) ) + ( log fasting glucose(mg/dL ) ) ] . Statistical Analysis Our primary end point was total weight loss at 1 year . Secondary analyses included the change from baseline in serum lipid levels , insulin sensitivity , and glycemic control . We estimated that we would need 100 persons ( 50 per group ) , assuming a 2-sided type I error of 5 % , for the study to have 80 % power to detect a 5-kg greater mean weight loss in the low-carbohydrate group than in the conventional diet group . These calculations were based on an anticipated maximum weight loss by 6 months , with weight stabilization in both diet groups between 6 months and 1 year . To compensate for an anticipated dropout rate of 25 % , we set our enrollment target at 135 persons . R and omization was performed by using a pre-established algorithm generated from a r and om set of numbers that was constructed and held in a separate center and concealed from those enrolling persons during r and omization . We used stratified r and omization , with blocking within strata , to ensure assignment of approximately equal numbers of women , diabetic persons , and severely obese persons ( BMI 40 kg/m2 ) to each study group . Changes in weight , dietary intake , and metabolic data were compared between the 2 diets by r and om-coefficient analysis ( 11 ) . This type of analysis was selected to allow for a variable number of observations for participants and to take into account that the repeated observations of the outcome variables over time for individuals were correlated . The r and om-coefficient analysis model takes these correlations into account by allowing the intercept to vary r and omly among persons . We used a restricted maximum likelihood analysis , which assumed that changes were distributed according to a bivariate normal distribution and that data were missing at r and om . The outcome variables were changes from baseline in weight , dietary macronutrient consumption , and metabolic measurements . For all of these analyses , the covariates included an indicator variable for time ( 6 months and 1 year ) , diet group , and a diet group by time interaction term . This diet group by time interaction term was kept in the model , regardless of its statistical significance ( P = 0.063 for the weight loss analysis ) . Separate analyses to adjust for baseline differences between diet groups were also made by entering the following covariates to each of these models : age ; race ( white or African American ) ; sex ; baseline BMI ; baseline caloric intake ; and the presence or absence of hypertension , use of lipid-lowering therapy , diabetes , active smoking , and sleep apnea ( 12 ) . All variables were assessed for normality before entry into the analyses . Triglyceride , insulin , and glucose levels were skewed and thus were log-transformed before the analyses . Baseline differences between diet groups were compared by chi-square analysis for dichotomous variables and by the unpaired t-test for continuous variables . All P values are 2-sided , and a P value of 0.05 was considered statistically significant . Analyses were performed with SPSS statistical software , version 11.1 ( SPSS , Inc. , Chicago , Illinois ) . Missing Data Of the 132 enrolled persons , follow-up was done at 6 months for 79 persons and at 1 year for 87 persons . For measurements at 6 months , we retrieved weights on an additional 16 persons on the low-carbohydrate diet and 23 persons on the conventional diet ( total , 39 persons at a mean [ SD ] of 6.6 1.2 months ) . For measurements at 1 year , we retrieved weights on 18 persons on the low-carbohydrate diet and 21 persons on the conventional diet ( total , 39 persons at a mean [ SD ] of 13.5 3.2 months ) . Thus , we had 6-month weights on 118 of 132 persons ( 89 % ) and 1-year weights on 126 of 132 persons ( 96 % ) . Of the 18 persons who missed the 6-month visit but returned for the 1-year visit ( 6 in the low-carbohydrate group and 12 in the conventional diet group ) , all but 2 had 6-month weights retrieved from medical records . Of the 6 persons for whom no 1-year weights were available , 2 were in the low-carbohydrate group and 4 in the conventional diet group . The weights retrieved from medical records were obtained on scales that were different from those used for the study and were probably obtained in a nonuniform manner with regard to clothing . We used several approaches to h and le the 45 participants with missing data for diet recall and metabolic measurements . For the primary analysis by r and om-coefficient analysis , we assumed data were missing at r and om . To verify this assumption , we performed sensitivity analyses based on comparisons of baseline characteristics and weight loss differences between those who dropped out and those who completed the study . We also performed 2 additional sensitivity",
"OBJECTIVE To investigate the relative efficacy of four popular weight-loss programmes on plasma lipids and lipoproteins as measures of CVD risk . DESIGN A multi-centred , r and omised , controlled trial of four diets - Dr Atkins ' New Diet Revolution , The Slim-Fast Plan , Weight Watchers Pure Points programme and Rosemary Conley 's ' Eat yourself Slim ' Diet and Fitness Plan - against a control diet , in parallel for 6 months . SETTING AND SUBJECTS The trial was conducted at five universities across the UK ( Surrey , Nottingham , Ulster ( Coleraine ) , Bristol and Edinburgh ( Queen Margaret University College ) ) and involved the participation of 300 overweight and obese males and females aged 21 - 60 years in a community setting . RESULTS Significant weight loss was achieved by all dieting groups ( 5 - 9 kg at 6 months ) but no significant difference was observed between diets at 6 months . The Weight Watchers and Rosemary Conley ( low-fat ) diets were followed by significant reductions in plasma LDL cholesterol ( both -12.2 % after 6 months , P Atkins ( low-carbohydrate ) and Weight Watchers diets were followed by marked reductions in plasma TAG ( -38.2 % and -22.6 % at 6 months respectively , P LDL particle size , a change that has been linked to reduced CVD risk . CONCLUSIONS Overall , these results demonstrate the favourable effects of weight loss on lipid-mediated CVD risk factors that can be achieved through commercially available weight-loss programmes . No detrimental effects on lipid-based CVD risk factors were observed in participants consuming a low-carbohydrate diet ",
"Hypoenergetic very low-carbohydrate and low-fat diets are both commonly used for short-term weight loss ; however , few studies have directly compared their effect on blood lipids , with no studies to our knowledge comparing postpr and ial lipemia , an important independently identified cardiovascular risk factor . The primary purpose of this study was to compare the effects of a very low-carbohydrate and a low-fat diet on fasting blood lipids and postpr and ial lipemia in overweight men . In a balanced , r and omized , crossover design , overweight men ( n = 15 ; body fat > 25 % ; BMI , 34 kg/m(2 ) ) consumed 2 experimental diets for 2 consecutive 6-wk periods . One was a very low-carbohydrate ( Blood was drawn from fasting subjects on separate days and an oral fat tolerance test was performed at baseline , after the very low-carbohydrate diet period , and after the low-fat diet period . Both diets had the same effect on serum total cholesterol , serum insulin , and homeostasis model analysis -insulin resistance ( HOMA-IR ) . Neither diet affected serum HDL cholesterol ( HDL-C ) or oxidized LDL ( oxLDL ) concentrations . Serum LDL cholesterol ( LDL-C ) was reduced ( P Fasting serum triacylglycerol ( TAG ) , the TAG/HDL-C ratio , and glucose were significantly reduced only by the very low-carbohydrate diet ( -44 , -42 , and -6 % , respectively ) . Postpr and ial lipemia was significantly reduced when the men consumed both diets compared with baseline , but the reduction was significantly greater after intake of the very low-carbohydrate diet . Mean and peak LDL particle size increased only after the very low-carbohydrate diet . The short-term hypoenergetic low-fat diet was more effective at lowering serum LDL-C , but the very low-carbohydrate diet was more effective at improving characteristics of the metabolic syndrome as shown by a decrease in fasting serum TAG , the TAG/HDL-C ratio , postpr and ial lipemia , serum glucose , an increase in LDL particle size , and also greater weight loss ( P < 0.05 )",
"BACKGROUND The optimal dietary content and type of fat and carbohydrate for weight management has been debated for decades . OBJECTIVE The objective was to compare the effects of 3 ad libitum diets on the maintenance of an initial weight loss of > or=8 % and risk factors for CVD and diabetes during a 6-mo controlled dietary intervention . DESIGN Nondiabetic overweight or obese [ mean + /- SD body mass index ( in kg/m(2 ) ) : 31.5 + /- 2.6 ] men ( n = 55 ) and women ( n = 76 ) aged 28.2 + /- 4.8 y were r and omly assigned to a diet providing a moderate amount of fat ( 35 - 45 % of energy ) and > 20 % of fat as monounsaturated fatty acids ( MUFA diet ; n = 54 ) , to a low-fat ( 20 - 30 % of energy ) diet ( LF diet ; n = 51 ) , or to a control diet ( 35 % of energy as fat ; n = 26 ) . Protein constituted 10 - 20 % of energy in all 3 diets . All foods were provided free of charge from a purpose -built supermarket . RESULTS More subjects dropped out of the MUFA ( 28 % ) group than out of the LF group ( 16 % ) and control group ( 8 % ) ( MUFA compared with control : P regained weight ( MUFA : 2.5 + /- 0.7 kg ; LF : 2.2 + /- 0.7 kg ; and control : 3.8 + /- 0.8 kg ; NS ) . Body fat regain was lower in the LF ( 0.6 + /- 0.6 % ) and MUFA ( 1.6 + /- 0.6 % ) groups than in the control group ( 2.6 + /- 0.5 % ) ( P fasting insulin decreased by 2.6 + /- 3.5 pmol/L , the homeostasis model assessment of insulin resistance by 0.17 + /- 0.13 , and the ratio of LDL to HDL by 0.33 + /- 0.13 ; in the LF group , these variables increased by 4.3 + /- 3.0 pmol/L ( P Dietary adherence was high on the basis of fatty acid changes in adipose tissue . CONCLUSIONS Diet composition had no major effect on preventing weight regain . However , both the LF and MUFA diets produced less body fat regain than did the control diet , and the dropout rate was lowest in the LF diet group , whereas fasting insulin decreased and the homeostasis model assessment of insulin resistance and ratio of LDL to HDL improved with the MUFA diet . This trial was registered at clinical trials.gov as NCT00274729",
"We tested whether nutrient intakes estimated from 4-d diet records were associated with plasma lipoprotein subclasses in 103 men who were r and omly assigned to a low-fat ( 24 % fat ) and a high-fat ( 46 % fat ) diet for 6 wk each in a crossover design . Postheparin plasma lipoprotein lipase ( LPL ) and hepatic lipase ( HL ) activities were also determined in a subset of 43 men . Changes in intake ( ie , high fat minus low fat ) of total saturated fatty acids , as well as myristic ( 14:0 ) and palmitic ( 16:0 ) acids , were positively correlated ( P large LDL particles [ measured by analytic ultra-centrifugation as mass of lipoproteins of flotation rate ( Sf ) 7 - 12 ] and with LDL peak particle diameter and flotation rate , but not with changes in LDL-cholesterol concentration . Changes in total saturated fatty acids as well as myristic and palmitic acids were also inversely associated with changes in HL activity ( P high-fat diet only , variation in dietary total saturated fatty acid intake was inversely correlated ( P small , dense LDL of Sf 0 - 5 . This correlation was significant specifically for myristic acid ( P Stearic acid ( 18:0 ) , monounsaturates , and polyunsaturates showed no significant associations with lipoprotein concentrations . These data indicate that a high saturated fat intake ( especially 14:0 and 16:0 ) is associated with increased concentrations of larger , cholesterol-enriched LDL and this occurs in association with decreased HL activity",
"BACKGROUND The possible advantage for weight loss of a diet that emphasizes protein , fat , or carbohydrates has not been established , and there are few studies that extend beyond 1 year . METHODS We r and omly assigned 811 overweight adults to one of four diets ; the targeted percentages of energy derived from fat , protein , and carbohydrates in the four diets were 20 , 15 , and 65 % ; 20 , 25 , and 55 % ; 40 , 15 , and 45 % ; and 40 , 25 , and 35 % . The diets consisted of similar foods and met guidelines for cardiovascular health . The participants were offered group and individual instructional sessions for 2 years . The primary outcome was the change in body weight after 2 years in two-by-two factorial comparisons of low fat versus high fat and average protein versus high protein and in the comparison of highest and lowest carbohydrate content . RESULTS At 6 months , participants assigned to each diet had lost an average of 6 kg , which represented 7 % of their initial weight ; they began to regain weight after 12 months . By 2 years , weight loss remained similar in those who were assigned to a diet with 15 % protein and those assigned to a diet with 25 % protein ( 3.0 and 3.6 kg , respectively ) ; in those assigned to a diet with 20 % fat and those assigned to a diet with 40 % fat ( 3.3 kg for both groups ) ; and in those assigned to a diet with 65 % carbohydrates and those assigned to a diet with 35 % carbohydrates ( 2.9 and 3.4 kg , respectively ) ( P>0.20 for all comparisons ) . Among the 80 % of participants who completed the trial , the average weight loss was 4 kg ; 14 to 15 % of the participants had a reduction of at least 10 % of their initial body weight . Satiety , hunger , satisfaction with the diet , and attendance at group sessions were similar for all diets ; attendance was strongly associated with weight loss ( 0.2 kg per session attended ) . The diets improved lipid-related risk factors and fasting insulin levels . CONCLUSIONS Reduced-calorie diets result in clinical ly meaningful weight loss regardless of which macronutrients they emphasize . ( Clinical Trials.gov number , NCT00072995 .",
"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 Long-term weight loss and cardiometabolic effects of a very-low-carbohydrate , high-saturated-fat diet ( LC ) and a high-carbohydrate , low-fat diet ( LF ) have not been evaluated under isocaloric conditions . OBJECTIVE The objective was to compare an energy-controlled LC diet with an LF diet at 1 y. DESIGN Men and women ( n = 118 ) with abdominal obesity and at least one additional metabolic syndrome risk factor were r and omly assigned to either an energy-restricted ( approximately 6 - 7 MJ ) LC diet ( 4 % , 35 % , and 61 % of energy as carbohydrate , protein , and fat , respectively ) or an isocaloric LF diet ( 46 % , 24 % , and 30 % of energy as carbohydrate , protein , and fat , respectively ) for 1 y. Weight , body composition , and cardiometabolic risk markers were assessed . RESULTS Sixty-nine participants ( 59 % ) completed the trial : 33 in the LC group and 36 in the LF group . Both groups lost similar amounts of weight ( LC : -14.5 + /- 1.7 kg ; LF : -11.5 + /- 1.2 kg ; P = 0.14 , time x diet ) and body fat ( LC : -11.3 + /- 1.5 kg ; LF : -9.4 + /- 1.2 kg ; P = 0.30 ) . Blood pressure , fasting glucose , insulin , insulin resistance , and C-reactive protein decreased independently of diet composition . Compared with the LF group , the LC group had greater decreases in triglycerides ( -0.36 + /- 0.15 mmol/L ; 95 % CI : -0.67 , -0.05 mmol/L ; P = 0.011 ) , increases in HDL cholesterol ( 0.23 + /- 0.09 mmol/L ; 95 % CI : 0.06 , 0.40 mmol/L ; P = 0.018 ) and LDL cholesterol ( 0.6 + /- 0.2 mmol/L ; 95 % CI : 0.2 , 1.0 mmol/L ; P = 0.001 ) , and a greater but nonsignificant increase in apolipoprotein B ( 0.08 + /- 0.04 g/L ; 95 % CI : -0.004 , 0.171 g/L ; P = 0.17 ) . CONCLUSIONS Under planned isoenergetic conditions , as expected , both dietary patterns result ed in similar weight loss and changes in body composition . The LC diet may offer clinical benefits to obese persons with insulin resistance . However , the increase in LDL cholesterol with the LC diet suggests that this measure should be monitored . This trial was registered with the Australian New Zeal and Clinical Trials Registry at ( http://www.anzctr.org.au ) as ACTR 12606000203550",
"BACKGROUND Low-carbohydrate diets are popular for weight loss , but their cardiovascular effects have not been well-studied , particularly in diverse population s. OBJECTIVE To examine the effects of a low-carbohydrate diet compared with a low-fat diet on body weight and cardiovascular risk factors . DESIGN A r and omized , parallel-group trial . ( Clinical Trials.gov : NCT00609271 ) . SETTING A large academic medical center . PARTICIPANTS 148 men and women without clinical cardiovascular disease and diabetes . INTERVENTION A low-carbohydrate ( Both groups received dietary counseling at regular intervals throughout the trial . MEASUREMENTS Data on weight , cardiovascular risk factors , and dietary composition were collected at 0 , 3 , 6 , and 12 months . RESULTS Sixty participants ( 82 % ) in the low-fat group and 59 ( 79 % ) in the low-carbohydrate group completed the intervention . At 12 months , participants on the low-carbohydrate diet had greater decreases in weight ( mean difference in change , -3.5 kg [ 95 % CI , -5.6 to -1.4 kg ] ; P = 0.002 ) , fat mass ( mean difference in change , -1.5 % [ CI , -2.6 % to -0.4 % ] ; P = 0.011 ) , ratio of total-high-density lipoprotein ( HDL ) cholesterol ( mean difference in change , -0.44 [ CI , -0.71 to -0.16 ] ; P = 0.002 ) , and triglyceride level ( mean difference in change , -0.16 mmol/L [ -14.1 mg/dL ] [ CI , -0.31 to -0.01 mmol/L { -27.4 to -0.8 mg/dL } ] ; P = 0.038 ) and greater increases in HDL cholesterol level ( mean difference in change , 0.18 mmol/L [ 7.0 mg/dL ] [ CI , 0.08 to 0.28 mmol/L { 3.0 to 11.0 mg/dL } ] ; P low-carbohydrate diet was more effective for weight loss and cardiovascular risk factor reduction than the low-fat diet . Restricting carbohydrate may be an option for persons seeking to lose weight and reduce cardiovascular risk factors . PRIMARY FUNDING SOURCE National Institutes of Health",
"Overweight and obese men and women ( 24 - 61 yr of age ) were recruited into a r and omized trial to compare the effects of a low-fat ( LF ) vs. a low-carbohydrate ( LC ) diet on weight loss . Thirty-one subjects completed all 10 wk of the diet intervention ( retention , 78 % ) . Subjects on the LF diet consumed an average of 17.8 % of energy from fat , compared with their habitual intake of 36.4 % , and had a result ing energy restriction of 2540 kJ/d . Subjects on the LC diet consumed an average of 15.4 % carbohydrate , compared with habitual intakes of about 50 % carbohydrate , and had a result ing energy restriction of 3195 kJ/d . Both groups of subjects had significant weight loss over the 10 wk of diet intervention and nearly identical improvements in body weight and fat mass . LF subjects lost an average of 6.8 kg and had a decrease in body mass index of 2.2 kg/m2 , compared with a loss of 7.0 kg and decrease in body mass index of 2.1 kg/m2 in the LC subjects . The LF group better preserved lean body mass when compared with the LC group ; however , only the LC group had a significant decrease in circulating insulin concentrations . Group results indicated that the diets were equally effective in reducing systolic blood pressure by about 10 mm Hg and diastolic pressure by 5 mm Hg and decreasing plasminogen activator inhibitor-1 bioactivity . Blood beta-hydroxybutyrate concentrations were increased in the LC only , at the 2- and 4-wk time points . These data suggest that energy restriction achieved by a very LC diet is equally effective as a LF diet strategy for weight loss and decreasing body fat in overweight and obese adults",
"OBJECTIVE Low-fat hypocaloric diets reduce insulin resistance and prevent type 2 diabetes in those at risk . Low-carbohydrate , high-fat diets are advocated as an alternative , but reciprocal increases in dietary fat may have detrimental effects on insulin resistance and offset the benefits of weight reduction . RESEARCH DESIGN AND METHODS We investigated a low-fat ( 20 % fat , 60 % carbohydrate ) versus a low-carbohydrate ( 60 % fat , 20 % carbohydrate ) weight reduction diet in 24 overweight/obese subjects ( [ mean ± SD ] BMI 33.6 ± 3.7 kg/m2 , aged 39 ± 10 years ) in an 8-week r and omized controlled trial . All food was weighed and distributed , and intake was calculated to produce a 500 kcal/day energy deficit . Insulin action was assessed by the euglycemic clamp and insulin secretion by meal tolerance test . Body composition , adipokine levels , and vascular compliance by pulse-wave analysis were also measured . RESULTS Significant weight loss occurred in both groups ( P ( P = 0.40 ) . Peripheral glucose uptake increased , but there was no difference between groups ( P = 0.28 ) , and suppression of endogenous glucose production was also similar between groups . Meal tolerance – related insulin secretion decreased with weight loss with no difference between groups ( P = 0.71 ) . The change in overall systemic arterial stiffness was , however , significantly different between diets ( P = 0.04 ) ; this reflected a significant decrease in augmentation index following the low-fat diet , compared with a nonsignificant increase within the low-carbohydrate group . CONCLUSIONS This study demonstrates comparable effects on insulin resistance of low-fat and low-carbohydrate diets independent of macronutrient content . The difference in augmentation index may imply a negative effect of low-carbohydrate diets on vascular risk",
"CONTEXT The results of clinical trials involving diet in the treatment of obesity have been inconsistent , possibly due to inherent physiological differences among study participants . OBJECTIVE To determine whether insulin secretion affects weight loss with 2 popular diets . DESIGN , SETTING , AND PARTICIPANTS R and omized trial of obese young adults ( aged 18 - 35 years ; n = 73 ) conducted from September 2004 to December 2006 in Boston , Mass , and consisting of a 6-month intensive intervention period and a 12-month follow-up period . Serum insulin concentration at 30 minutes after a 75-g dose of oral glucose was determined at baseline as a measure of insulin secretion . Outcomes were assessed at 6 , 12 , and 18 months . Missing data were imputed conservatively . INTERVENTIONS A low-glycemic load ( 40 % carbohydrate and 35 % fat ) vs low-fat ( 55 % carbohydrate and 20 % fat ) diet . MAIN OUTCOME MEASURES Body weight , body fat percentage determined by dual-energy x-ray absorptiometry , and cardiovascular disease risk factors . RESULTS Change in body weight and body fat percentage did not differ between the diet groups overall . However , insulin concentration at 30 minutes after a dose of oral glucose was an effect modifier ( group x time x insulin concentration at 30 minutes : P = .02 for body weight and P = .01 for body fat percentage ) . For those with insulin concentration at 30 minutes above the median ( 57.5 microIU/mL ; n = 28 ) , the low-glycemic load diet produced a greater decrease in weight ( -5.8 vs -1.2 kg ; P = .004 ) and body fat percentage ( -2.6 % vs -0.9 % ; P = .03 ) than the low-fat diet at 18 months . There were no significant differences in these end points between diet groups for those with insulin concentration at 30 minutes below the median level ( n = 28 ) . Insulin concentration at 30 minutes after a dose of oral glucose was not a significant effect modifier for cardiovascular disease risk factors . In the full cohort , plasma high-density lipoprotein cholesterol and triglyceride concentrations improved more on the low-glycemic load diet , whereas low-density lipoprotein cholesterol concentration improved more on the low-fat diet . CONCLUSIONS Variability in dietary weight loss trials may be partially attributable to differences in hormonal response . Reducing glycemic load may be especially important to achieve weight loss among individuals with high insulin secretion . Regardless of insulin secretion , a low-glycemic load diet has beneficial effects on high-density lipoprotein cholesterol and triglyceride concentrations but not on low-density lipoprotein cholesterol concentration . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00130299",
"Background Optimal macronutrient distribution of weight loss diets has not been established . The distribution of energy from carbohydrate and fat has been observed to promote differential plasma lipid responses in previous weight loss studies , and insulin resistance status may interact with diet composition and affect weight loss and lipid responses . Methods and Results Overweight and obese women ( n=245 ) were enrolled in a 1‐year behavioral weight loss intervention and r and omly assigned to 1 of 3 study groups : a lower fat ( 20 % energy ) , higher carbohydrate ( 65 % energy ) diet ; a lower carbohydrate ( 45 % energy ) , higher fat ( 35 % energy ) diet ; or a walnut‐rich , higher fat ( 35 % energy ) , lower carbohydrate ( 45 % energy ) diet . Blood sample s and data available from 213 women at baseline and at 6 months were the focus of this analysis . Triglycerides , total cholesterol , and high‐ and low‐density lipoprotein cholesterol were quantified and compared between and within groups . Triglycerides decreased in all study arms at 6 months ( P increased high‐density lipoprotein cholesterol more than either the lower fat or lower carbohydrate diet ( P reduced low‐density lipoprotein cholesterol in insulin‐sensitive women , whereas the lower fat diet reduced both total cholesterol and high‐density lipoprotein cholesterol in insulin‐sensitive women ( P ) . Insulin sensitivity and C‐reactive protein levels also improved . Conclusions Weight loss was similar across the diet groups , although insulin‐sensitive women lost more weight with a lower fat , higher carbohydrate diet versus a higher fat , lower carbohydrate diet . The walnut‐rich , higher fat diet result ed in the most favorable changes in lipid levels . Clinical Trial Registration URL : http://www . clinical trials.gov . Unique identifier : NCT01424007",
"OBJECTIVE Long-term dietary intervention frequently induces a rapid weight decline followed by weight stabilization/regain . Here , we sought to identify adipokine biomarkers that may reflect continued beneficial effects of dieting despite partial weight regain . RESEARCH DESIGN AND METHODS We analyzed the dynamics of fasting serum levels of 12 traditional metabolic biomarkers and novel adipokines among 322 participants in the 2-year Dietary Intervention R and omized Controlled Trial ( DIRECT ) of low-fat , Mediterranean , or low-carbohydrate diets for weight loss . RESULTS We identified two distinct patterns : Pattern A includes biomarkers ( insulin , triglycerides , leptin , chemerin , monocyte chemoattractant protein 1 , and retinol-binding protein 4 ) whose dynamics tightly correspond to changes in body weight , with the trend during the weight loss phase ( months 0–6 ) going in the opposite direction to that in the weight maintenance/regain phase ( months 7–24 ) ( P ( high molecular weight adiponectin , HDL cholesterol [ HDL-C ] , high-sensitivity C-reactive protein [ hsCRP ] , fetuin-A , progranulin , and vaspin ) that displayed a continued , cumulative improvement ( P leptin ( pattern A ) was most closely linked to weight change and that the dynamic of hsCRP best typified pattern B. CONCLUSIONS hsCRP , HDL-C , adiponectin , fetuin-A , progranulin , and vaspin levels display a continued long-term improvement despite partial weight regain . This may likely reflect either a delayed effect of the initial weight loss or a continuous beneficial response to switching to healthier dietary patterns",
"Context Low-carbohydrate weight reduction diets are popular despite a dearth of data on long-term efficacy and adverse effects . Contribution Community-dwelling hyperlipidemic persons were r and omly assigned to either a low-carbohydrate , ketogenic diet or a low-fat , low-cholesterol , reduced-calorie diet for 24 weeks . Compared to the low-fat group , patients in the low-carbohydrate group lost more weight , had a greater decrease in triglyceride levels , and had higher high-density lipoprotein cholesterol levels . Levels of low-density lipoprotein cholesterol remained stable in both groups . Side effects were more common in the low-cholesterol group but were generally mild . Caution s While the study suggests the efficacy and relative safety of the low-cholesterol diet , the high dropout rate , self-directed adherence to the diet , and relatively short observation period challenge the generalizability of the findings . The Editors As the prevalence of obesity has increased over the past 20 years ( 1 ) , the difficulties faced by overweight patients and their health care practitioners have become apparent . Fewer than 25 % of Americans who attempt to lose weight actually reduce caloric intake and increase exercise as currently recommended ( 2 ) . Persons who successfully lose weight have difficulty maintaining their weight loss ( 3 ) . Therefore , it is not surprising that consumers spend $ 33 billion yearly on weight loss products and services in search of effective therapies ( 2 ) . Because many weight loss interventions are unproven and untested , practitioners often lack information with which to recommend a certain therapy or to monitor a patient once a therapy is chosen . One approach to weight loss that has gained recognition in the face of modest supportive scientific evidence is the low-carbohydrate diet . A popular version of this diet recommends extreme restriction of carbohydrate intake to less than 20 g/d initially ( 4 ) . This level of carbohydrate restriction can induce serum and urinary ketones and weight loss ( 5 , 6 ) . However , until recently , available data on low-carbohydrate diets came from small studies of short duration , most of which were uncontrolled ( 5 , 7 - 10 ) . We examined body weight , body composition , serum lipid levels , and adverse effects over 24 weeks in hyperlipidemic persons who were r and omly assigned to follow a low-carbohydrate , ketogenic diet or a low-fat , low-cholesterol , reduced-calorie diet commonly used to induce weight loss and decrease serum lipid levels . Methods Participants Generally healthy persons were recruited from the community . Inclusion criteria were age 18 to 65 years , body mass index of 30 to 60 kg/m2 , desire to lose weight , elevated lipid levels ( total cholesterol level > 5.17 mmol/L [ > 200 mg/dL ] , low-density lipoprotein [ LDL ] cholesterol level > 3.36 mmol/L [ > 130 mg/dL ] , or triglyceride level > 2.26 mmol/L [ 200 mg/dL ] ) , and no serious medical condition . Exclusion criteria were use of any prescription medication in the previous 2 months ( except for oral contraceptives , estrogen therapy , and stable thyroid medication ) , pregnancy or breastfeeding , use of any weight loss diet or diet pills in the previous 6 months , and baseline ketonuria . All participants provided written informed consent , and the institutional review board of Duke University Health System approved the study . Participants received no monetary incentive . Interventions By using a computer-generated simple r and omization list , participants were allocated to receive the low-carbohydrate diet or low-fat diet . The intervention for both groups included group meetings , diet instruction , and an exercise recommendation . Group meetings took place at an outpatient research clinic twice monthly for 3 months , then monthly for 3 months . These meetings typically lasted 1 hour and consisted of diet instruction , supportive counseling , question naires , and biomedical measurements . During the study , participants selected their own menus and prepared or bought their own meals according to the guidelines presented to them . Participants were encouraged to exercise for 30 minutes at least 3 times weekly , but no formal exercise program or incentives were provided . Low-Carbohydrate Diet Using a popular diet book published by a lay press and additional h and outs , trained research staff instructed participants to restrict intake of carbohydrates to less than 20 g/d ( 4 ) . Participants were permitted unlimited amounts of animal foods ( meat , fowl , fish , and shellfish ) , unlimited eggs , 4 oz of hard cheese , 2 cups of salad vegetables ( such as lettuce , spinach , or celery ) , and 1 cup of low-carbohydrate vegetables ( such as broccoli , cauliflower , or squash ) daily . Participants were encouraged to drink 6 to 8 glasses of water daily . When participants were halfway to their goal body weight ( determined at the week 10 visit with assistance from research personnel ) , they were advised to add approximately 5 g of carbohydrates to their daily intake each week until they reached a level at which body weight was maintained . To simulate the practice of the study sponsor , the low-carbohydrate diet group also received daily nutritional supplements ( multivitamin , essential oils , diet formulation , and chromium picolinate ; for a list of the composition of these supplements , see the Appendix ) ( 6 ) . Low-Fat Diet Using a commonly available booklet and additional h and outs , a registered dietitian instructed participants in a diet consisting of less than 30 % of daily energy intake from fat , less than 10 % of daily energy intake from saturated fat , and less than 300 mg of cholesterol daily ( 11 , 12 ) . The recommended energy intake was 2.1 to 4.2 MJ ( 500 to 1000 kcal ) less than the participant 's calculated energy intake for weight maintenance ( body weight in pounds 10 ) ( 13 ) . Primary Outcome Measure Body weight and body mass index were the primary outcome measures . At each visit , participants were weighed on the same calibrated scale while wearing lightweight clothing and no shoes . Body mass index was calculated as body weight in kilograms divided by height in meters squared . Secondary Outcome Measures Adherence Adherence to the diet was measured by self-report , food records , and , for the low-carbohydrate diet group , urinary ketone assessment . Diet Composition All participants completed a 24-hour recall of food intake at baseline and take-home food records ( 5 consecutive days , including a weekend ) that were collected at each meeting during the study . Participants were instructed on how to document food intake and were given h and outs with examples of how to complete the records . A sample of participants ( 13 in the low-carbohydrate diet group and 7 in the low-fat diet group ) who completed the study was selected for food record analysis by the research staff on the basis of adequacy of detail in their records . A registered dietitian analyzed the food records by using a nutrition software program ( Nutritionist Five , version 1.6 [ First Data Bank , Inc. , San Bruno , California ] ) . Ketonuria Restriction of dietary intake of carbohydrates to less than 40 g/d typically results in ketonuria that is detectable by dipstick analysis , which can be used to monitor adherence to the low-carbohydrate diet ( 14 , 15 ) . At each return visit , participants provided a fresh urine specimen for analysis . The following semi-quantitative scale was used to categorize ketone content : none , trace ( up to 0.9 mmol/L [ 5 mg/dL ] ) , small ( 0.9 to 6.9 mmol/L [ 5 to 40 mg/dL ] ) , moderate ( 6.9 to 13.8 mmol/L [ 40 to 80 mg/dL ] ) , large80 ( 13.8 to 27.5 mmol/L [ 80 to 160 mg/dL ] ) , and large160 ( > 27.5 mmol/L [ > 160 mg/dL ] ) . Body Composition Body composition was estimated by using bioelectric impedance ( model TBF-300A [ Tanita Corp. , Arlington Heights , Illinois ] ) at approximately the same time of day ( afternoon or evening ) at each return visit . In a subset of 33 participants , the percentage of body fat as measured by bioelectric impedance had excellent correlation with the percentage as measured by dual-energy x-ray absorptiometry ( r = 0.93 [ 95 % CI , 0.87 to 0.97 ] ) . Vital Signs Blood pressure and pulse rate were measured in the nondominant arm by using an automated digital cuff ( model HEM-725C [ Omron Corp. , Vernon Hills , Illinois ] ) after the participant had been sitting for 3 minutes . Two measurements were taken at each visit and averaged for the analysis . Serum Lipids and Lipoproteins Serum specimens for lipid measurement were obtained in the morning after at least 8 hours of fasting at the screening visit and at 8 , 16 , and 24 weeks . Other Metabolic Effects Serum tests for sodium , potassium , chloride , urea nitrogen , creatinine , calcium , phosphorus , total protein , albumin , uric acid , total bilirubin , alanine aminotransferase , aspartate aminotransferase , alkaline phosphatase , thyroid-stimulating hormone , iron , hemoglobin , leukocyte count , and platelet count were obtained at the screening visit and at 8 , 16 , and 24 weeks . The glomerular filtration rate was estimated by using an equation that included age ; sex ; race ; and serum levels of albumin , creatinine , and urea nitrogen ( Modification of Diet in Renal Disease Study equation ) ( 16 ) . Adverse Effects At all return visits , participants completed an open-ended question naire on side effects . At the 20- and 24-week visits , participants completed a checklist of the side effects that were most often mentioned during the study . Statistical Analysis Analyses were performed by using S-PLUS software , version 6.1 ( Insightful Corp. , Seattle , Washington ) , or SAS software , version 8.02 ( SAS Institute , Inc. , Cary , North Carolina ) . For categorical outcomes , groups were compared by using the chi-square test or Fisher exact test , as appropriate . For all primary and secondary continuous outcomes , linear mixed-effects models ( PROC MIXED procedure in SAS software ) that included fixed and r and om effects were used to determine expected mean values at each time point and to test hypotheses of group differences . In most body weight and",
"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",
"Little is known about whether cholesteryl ester transfer protein ( CETP ) genetic variation may modify the effect of weight-loss diets varying in fat content on changes in lipid levels . We analyzed the interaction between the CETP variant rs3764261 and dietary interventions on changes in lipid levels among 732 overweight/obese adults from a 2 year r and omized weight-loss trial [ Preventing Overweight Using Novel Dietary Strategies ( POUNDS LOST ) ] , and replicated the findings in 171 overweight/obese adults from an independent 2 year weight-loss trial [ Dietary Intervention R and omized Controlled Trial ( DIRECT ) ] . In the POUNDS LOST , participants with the CETP rs3764261 CC genotype on the high-fat diet had larger increases in HDL cholesterol ( P = 0.001 ) and decreases in triglycerides ( P = 0.007 ) than those on the low-fat diet at 6 months , while no significant difference between these two diets was observed among participants carrying other genotypes . The gene-diet interactions on changes in HDL-cholesterol and triglycerides were replicated in the DIRECT ( pooled P for interaction ≤ 0.01 ) . Similar results on trajectory of changes in HDL cholesterol and triglycerides over the 2 year intervention were observed in both trials . Our study provides replicable evidence that individuals with the CETP rs3764261 CC genotype might derive greater effects on raising HDL cholesterol and lowering triglycerides by choosing a low-carbohydrate/high-fat weight-loss diet instead of a low-fat diet",
"CONTEXT The scarcity of data addressing the health effects of popular diets is an important public health concern , especially since patients and physicians are interested in using popular diets as individualized eating strategies for disease prevention . OBJECTIVE To assess adherence rates and the effectiveness of 4 popular diets ( Atkins , Zone , Weight Watchers , and Ornish ) for weight loss and cardiac risk factor reduction . DESIGN , SETTING , AND PARTICIPANTS A single-center r and omized trial at an academic medical center in Boston , Mass , of overweight or obese ( body mass index : mean , 35 ; range , 27 - 42 ) adults aged 22 to 72 years with known hypertension , dyslipidemia , or fasting hyperglycemia . Participants were enrolled starting July 18 , 2000 , and r and omized to 4 popular diet groups until January 24 , 2002 . INTERVENTION A total of 160 participants were r and omly assigned to either Atkins ( carbohydrate restriction , n=40 ) , Zone ( macronutrient balance , n=40 ) , Weight Watchers ( calorie restriction , n=40 ) , or Ornish ( fat restriction , n=40 ) diet groups . After 2 months of maximum effort , participants selected their own levels of dietary adherence . MAIN OUTCOME MEASURES One-year changes in baseline weight and cardiac risk factors , and self-selected dietary adherence rates per self-report . RESULTS Assuming no change from baseline for participants who discontinued the study , mean ( SD ) weight loss at 1 year was 2.1 ( 4.8 ) kg for Atkins ( 21 [ 53 % ] of 40 participants completed , P = .009 ) , 3.2 ( 6.0 ) kg for Zone ( 26 [ 65 % ] of 40 completed , P = .002 ) , 3.0 ( 4.9 ) kg for Weight Watchers ( 26 [ 65 % ] of 40 completed , P low-density lipoprotein/high-density lipoprotein ( HDL ) cholesterol ratio by approximately 10 % ( all P blood pressure or glucose at 1 year . Amount of weight loss was associated with self-reported dietary adherence level ( r = 0.60 ; P total/HDL cholesterol , C-reactive protein , and insulin were significantly associated with weight loss ( mean r = 0.36 , 0.37 , and 0.39 , respectively ) with no significant difference between diets ( P = .48 , P = .57 , P = .31 , respectively ) . CONCLUSIONS Each popular diet modestly reduced body weight and several cardiac risk factors at 1 year . Overall dietary adherence rates were low , although increased adherence was associated with greater weight loss and cardiac risk factor reductions for each diet group",
"Examining predictors of blood-pressure ( BP ) response to weight-loss diets might provide insight into mechanisms and help guide clinical care . We examined whether certain baseline patient characteristics ( e.g. diet , medical history and laboratory tests ) predicted BP response to two weight-loss diet approaches that differ in macronutrient content . One hundred and forty-six overweight adult out patients were r and omized to either a low-carbohydrate diet ( N = 72 ) or orlistat plus a low-fat diet ( N = 74 ) for 48 weeks . Predictors of BP reduction were evaluated using a structured approach and r and om effects regression models . Participants were 56 % African-American , 72 % male and 53 ( ±10 ) years-old . Of the variables considered , low baseline high-density lipoprotein ( HDL ) predicted greater reduction in BP in those patients who received the low-carbohydrate diet ( p = 0.03 for systolic BP ; p = 0.03 for diastolic BP and p = 0.02 for mean arterial pressure ) . A low HDL level may identify patients who will have greater BP improvement on a low-carbohydrate diet",
"OBJECTIVE Low-carbohydrate diets have become a popular alternative to st and ard diets for weight loss . Our aim was to compare the cost-effectiveness of these two diets . RESEARCH METHODS AND PROCEDURES The patient population included 129 severely obese subjects ( BMI = 42.9 ) from a r and omized trial ; participants had a high prevalence of diabetes or metabolic syndrome . We compared within-trial costs , quality -adjusted life years ( QALYs ) , and the incremental cost-effectiveness ratio ( CER ) for the two study groups . We imputed missing values for QALYs . The CER was bootstrapped to derive 95 % confidence intervals and to define acceptability cut-offs . We took a societal perspective for our analysis . RESULTS Total costs during the one year of the trial were 6742 dollars + /- 6675 and 6249 dollars + /- 5100 for the low-carbohydrate and st and ard groups , respectively ( p = 0.78 ) . Participants experienced 0.64 + /- 0.02 and 0.61 + /- 0.02 QALYs during the one year of the study , respectively ( p = 0.17 for difference ) . The point estimate of the incremental CER was -1225 dollars/QALY ( i.e. , the low-carbohydrate diet dominated the st and ard diet ) . However , in the bootstrap analysis , the wide spread of CERs caused the 95 % confidence interval to be undefined . The probabilities that the low-carbohydrate diet was acceptable , using cut-offs of 50,000 dollars/QALY , 100,000 dollars/QALY , and 150,000 dollars/QALY , were 72.4 % 78.6 % , and 79.8 % , respectively . DISCUSSION The low-carbohydrate diet was not more cost-effective for weight loss than the st and ard diet in the patient population studied . Larger studies are needed to better assess the cost-effectiveness of dietary therapies for weight loss",
"BACKGROUND Despite the popularity of the low-carbohydrate , high-protein , high-fat ( Atkins ) diet , no r and omized , controlled trials have evaluated its efficacy . METHODS We conducted a one-year , multicenter , controlled trial involving 63 obese men and women who were r and omly assigned to either a low-carbohydrate , high-protein , high-fat diet or a low-calorie , high-carbohydrate , low-fat ( conventional ) diet . Professional contact was minimal to replicate the approach used by most dieters . RESULTS Subjects on the low-carbohydrate diet had lost more weight than subjects on the conventional diet at 3 months ( mean [ + /-SD ] , -6.8+/-5.0 vs. -2.7+/-3.7 percent of body weight ; P=0.001 ) and 6 months ( -7.0+/-6.5 vs. -3.2+/-5.6 percent of body weight , P=0.02 ) , but the difference at 12 months was not significant ( -4.4+/-6.7 vs. -2.5+/-6.3 percent of body weight , P=0.26 ) . After three months , no significant differences were found between the groups in total or low-density lipoprotein cholesterol concentrations . The increase in high-density lipoprotein cholesterol concentrations and the decrease in triglyceride concentrations were greater among subjects on the low-carbohydrate diet than among those on the conventional diet throughout most of the study . Both diets significantly decreased diastolic blood pressure and the insulin response to an oral glucose load . CONCLUSIONS The low-carbohydrate diet produced a greater weight loss ( absolute difference , approximately 4 percent ) than did the conventional diet for the first six months , but the differences were not significant at one year . The low-carbohydrate diet was associated with a greater improvement in some risk factors for coronary heart disease . Adherence was poor and attrition was high in both groups . Longer and larger studies are required to determine the long-term safety and efficacy of low-carbohydrate , high-protein , high-fat diets",
"Background —Oxidized LDL ( oxLDL ) is thought to play a key role in the inflammatory response in the arterial vessel wall . Methods and Results —In a prospect i ve , nested , case-control study , the association between plasma oxLDL and risk of an acute coronary heart disease ( CHD ) event was investigated in men without prevalent CHD or diabetes mellitus at baseline . Subjects came from 2 population -based MONICA/KORA Augsburg surveys conducted in the years 1989–1990 and 1994–1995 with follow-up in 1998 ( mean±SD follow-up time , 5.6±2.6 years ) . OxLDL was determined by ELISA in 88 men with incident CHD and in 258 age- and survey-matched controls . Hazard ratios ( HRs ) were estimated from conditional logistic-regression models with matching for age and survey . Baseline mean plasma oxLDL concentrations were significantly higher in subjects who subsequently experienced an event compared with controls ( mean±SD , 110±32 versus 93±28 U/L ; P≤0.001 ) . After adjustment for smoking , hypertension , obesity , physical activity , education , and alcohol consumption , the HR for a future CHD event in a comparison of the upper tertile of the oxLDL distribution with the lower tertile was 4.25 ( 95 % confidence interval , 2.09 to 8.63 ; P . Plasma oxLDL was the strongest predictor of CHD events compared with a conventional lipoprotein profile and other traditional risk factors for CHD . When both oxLDL and C-reactive protein were simultaneously assessed in the same model , they still predicted future CHD events even after multivariable adjustment . Conclusions —Elevated concentrations of oxLDL are predictive of future CHD events in apparently healthy men . Thus , oxLDL may represent a promising risk marker for clinical CHD complications and should be evaluated in further studies",
"Background We investigated whether macronutrient composition of energy-restricted diets influences the efficacy of a telemedically guided weight loss program . Methods Two hundred overweight subjects were r and omly assigned to a conventional low-fat diet and a low-carbohydrate diet group ( target carbohydrate content : > 55 % energy and weekly nutrition education program and dietary counselling by telephone , and had to transfer actual body weight data to our clinic weekly with added Bluetooth ® technology by mobile phone . Various fatness and fat distribution parameters , energy and macronutrient intake , and various biochemical risk markers were measured at baseline and after 6 , and 12 months . Results In both groups , energy intake decreased by 400 kcal/d compared to baseline values within the first 6 months and slightly increased again within the second 6 months . Macronutrient composition differed significantly between the groups from the beginning to month 12 . At study termination , weight loss was 5.8 kg ( SD : 6.1 kg ) in the low-carbohydrate group and 4.3 kg ( SD : 5.1 kg ) in the low-fat group ( p = 0.065 ) . In the low-carbohydrate group , triglyceride and HDL-cholesterol levels were lower at month 6 and waist circumference and systolic blood pressure were lower at month 12 compared with the low-fat group ( P = 0.005–0.037 ) . Other risk markers improved to a similar extent in both groups . Conclusion Despite favourable effects of both diets on weight loss , the carbohydrate-reduced diet was more beneficial with respect to cardiovascular risk factors compared to the fat-reduced diet . Nevertheless , compliance with a weight loss program appears to be even a more important factor for success in prevention and treatment of obesity than the composition of the diet . Trial registration Clinical trials.gov as",
"Our aim was to determine whether short-term weight loss on a low-carbohydrate/low-saturated fat diet improved endothelial function compared with a conventional high-carbohydrate diet , as this diet is expected to lower both blood glucose and LDL-cholesterol . In a r and omised parallel design of two energy-restricted diets in an outpatient setting , thirty-six subjects ( BMI 33 ( sem 4 ) kg/m2 ) were r and omised to a low- or high-carbohydrate diet both low in saturated fat . Flow-mediated dilatation ( FMD ) , fasting glucose , insulin , lipids , adiponectin and adhesion molecules were measured at baseline , during weight loss and at 52 weeks . FMD did not change with either diet ( 5.2 ( sem 0.6 ) to 5.5 ( sem 0.6 ) % ) despite weight loss of 5 % and significant reductions in glucose and insulin and LDL-cholesterol and was not different after sustained weight loss of 5 % at 52 weeks . Adiponectin fell by 6 % at 12 weeks ( P = 0.1 ) with weight loss but rose by 17 % at 12 months ( P weight loss . There were no effects of diet . In contradistinction , adhesion molecules fell at 12 weeks , vascular cell adhesion molecule-1 by 14 % and intracellular adhesion molecule-1 by 13 % ( both P in HDL ( r 0.778 , P glucose ( r - 0.563 , P = 0.057 ) . In summary , weight loss does not improve FMD . Novel cardiovascular risk factors improved at 12 weeks but the improvement in adiponectin was delayed",
"CONTEXT Evidence is conflicting regarding the performance of apolipoproteins vs traditional lipids for predicting coronary heart disease ( CHD ) risk . OBJECTIVES To compare performance of different lipid measures for CHD prediction using discrimination and calibration characteristics and reclassification of risk categories ; to assess incremental utility of apolipoproteins over traditional lipids for CHD prediction . DESIGN , SETTING , AND PARTICIPANTS Population -based , prospect i ve cohort from , Framingham , Massachusetts . We evaluated serum total cholesterol , high-density lipoprotein cholesterol ( HDL-C ) , low-density lipoprotein cholesterol ( LDL-C ) , non-HDL-C , apolipoprotein ( apo ) A-I and apo B , and 3 lipid ratios ( total cholesterol : HDL-C , LDL-C : HDL-C , and apo B : apo A-I ) in 3322 middle-aged white participants who attended the fourth offspring examination cycle ( 1987 - 1991 ) and were without cardiovascular disease . Fifty-three percent of the participants were women . MAIN OUTCOME MEASURE Incidence of first CHD event ( recognized or unrecognized myocardial infa rct ion , angina pectoris , coronary insufficiency , or coronary heart disease death ) . RESULTS After a median follow-up of 15.0 years , 291 participants , 198 of whom were men , developed CHD . In multivariate models adjusting for nonlipid risk factors , the apo B : apo A-I ratio predicted CHD ( hazard ratio [ HR ] per SD increment , 1.39 ; 95 % confidence interval [ CI ] , 1.23 - 1.58 in men and HR , 1.40 ; 95 % CI , 1.16 - 1.67 in women ) , but risk ratios were similar for total cholesterol : HDL-C ( HR , 1.39 ; 95 % CI , 1.22 - 1.58 in men and HR , 1.39 ; 95 % CI , 1.17 - 1.66 in women ) and for LDL-C : HDL-C ( HR , 1.35 ; 95 % CI , 1.18 - 1.54 in men and HR , 1.36 ; 95 % CI 1.14 - 1.63 in women ) . In both sexes , models using the apo B : apo A-I ratio demonstrated performance characteristics comparable with but not better than that for other lipid ratios . The apo B : apo A-I ratio did not predict CHD risk in a model containing all components of the Framingham risk score including total cholesterol : HDL-C ( P = .12 in men ; P = .58 in women ) . CONCLUSIONS In this large , population -based cohort , the overall performance of apo B : apo A-I ratio for prediction of CHD was comparable with that of traditional lipid ratios but did not offer incremental utility over total cholesterol : HDL-C. These data do not support measurement of apo B or apo A-I in clinical practice when total cholesterol and HDL-C measurements are available",
"OBJECTIVES This study was design ed to test the hypothesis that at any low-density lipoprotein cholesterol ( LDL-C ) level , other lipid parameters such as non-high-density lipoprotein cholesterol ( HDL-C ) levels , triglyceride ( TG ) levels , and the total cholesterol (TC)/HDL-C are still associated with an increased coronary heart disease ( CHD ) risk . BACKGROUND Although LDL-C is considered to be the primary target of lipid-lowering therapy , other parameters of the lipoprotein-lipid profile may more closely associated with CHD risk . METHODS In the EPIC ( European Prospect i ve Investigation Into Cancer and Nutrition)-Norfolk prospect i ve population study , 21,448 participants without diabetes or CHD between age 45 and 79 years were followed for 11.0 years . A total of 2,086 participants developed CHD during follow-up . RESULTS Among individuals with low LDL-C levels ( 130 mg/dl had a hazard ratio ( HR ) for future CHD of 1.84 ( 95 % confidence interval [ CI ] : 1.12 to 3.04 ) when compared with those with non-HDL-C levels TG levels > 150 mg/dl had an HR of 1.63 ( 95 % CI : 1.02 to 2.59 ) when compared with those with TG levels TC/HDL-C ratio > 5 had an HR of 2.19 ( 95 % CI : 1.22 to 3.93 ) when compared with those with a TC/HDL-C ratio plasma LDL-C levels , participants with high non-HDL-C levels , high TG levels , or with an elevated TC/HDL-C ratio were at increased CHD risk . CHD risk assessment algorithms as well as lipid targets of lipid-lowering trials may also need to consider other easily available parameters such as",
"BACKGROUND Two potent weight loss therapies , a low-carbohydrate , ketogenic diet ( LCKD ) and orlistat therapy combined with a low-fat diet ( O + LFD ) , are available to the public but , to our knowledge , have never been compared . METHODS Overweight or obese out patients ( n = 146 ) from the Department of Veterans Affairs primary care clinics in Durham , North Carolina , were r and omized to either LCKD instruction ( initially , , 120 mg orally 3 times daily , plus low-fat diet instruction ( 30 % energy from fat , 500 - 1000 kcal/d deficit ) delivered at group meetings over 48 weeks . Main outcome measures were body weight , blood pressure , fasting serum lipid , and glycemic parameters . RESULTS The mean age was 52 years and mean body mass index was 39.3 ( calculated as weight in kilograms divided by height in meters squared ) ; 72 % were men , 55 % were black , and 32 % had type 2 diabetes mellitus . Of the study participants , 57 of the LCKD group ( 79 % ) and 65 of the O + LFD group ( 88 % ) completed measurements at 48 weeks . Weight loss was similar for the LCKD ( expected mean change , -9.5 % ) and the O + LFD ( -8.5 % ) ( P = .60 for comparison ) groups . The LCKD had a more beneficial impact than O + LFD on systolic ( -5.9 vs 1.5 mm Hg ) and diastolic ( -4.5 vs 0.4 mm Hg ) blood pressures ( P High-density lipoprotein cholesterol and triglyceride levels improved similarly within both groups . Low-density lipoprotein cholesterol levels improved within the O + LFD group only , whereas glucose , insulin , and hemoglobin A(1c ) levels improved within the LCKD group only ; comparisons between groups , however , were not statistically significant . CONCLUSION In a sample of medical out patients , an LCKD led to similar improvements as O + LFD for weight , serum lipid , and glycemic parameters and was more effective for lowering blood pressure . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00108524",
"PURPOSE To compare the effects of a low-carbohydrate diet and a conventional ( fat- and calorie-restricted ) diet on lipoprotein subfractions and inflammation in severely obese subjects . METHODS We compared changes in lipoprotein subfractions and C-reactive protein levels in 78 severely obese subjects , including 86 % with either diabetes or metabolic syndrome , who were r and omly assigned to either a low-carbohydrate or conventional diet for 6 months . RESULTS Subjects on a low-carbohydrate diet experienced a greater decrease in large very low-density lipoprotein ( VLDL ) levels ( difference = -0.26 mg/dL , p = .03 ) but more frequently developed detectable chylomicrons ( 44 % vs 22 % , p = .04 ) . Both diet groups experienced similar decreases in the number of low-density lipoprotein ( LDL ) particles ( difference = -30 nmol/L , p = .74 ) and increases in large high-density lipoprotein ( HDL ) concentrations ( difference = 0.70 mg/dL , p = .63 ) . Overall , C-reactive protein levels decreased modestly in both diet groups . However , patients with a high-risk baseline level ( > 3 mg/dL , n = 48 ) experienced a greater decrease in C-reactive protein levels on a low-carbohydrate diet ( adjusted difference = -2 mg/dL , p = .005 ) , independent of weight loss . CONCLUSIONS In this 6-month study involving severely obese subjects , we found an overall favorable effect of a low-carbohydrate diet on lipoprotein subfractions and on inflammation in high-risk subjects . Both diets had similar effects on LDL and HDL subfractions . ( Am J Med . 2004;117:398 - 405 . )",
"Untested alternative weight loss diets , such as very low carbohydrate diets , have unsubstantiated efficacy and the potential to adversely affect cardiovascular risk factors . Therefore , we design ed a r and omized , controlled trial to determine the effects of a very low carbohydrate diet on body composition and cardiovascular risk factors . Subjects were r and omized to 6 months of either an ad libitum very low carbohydrate diet or a calorie-restricted diet with 30 % of the calories as fat . Anthropometric and metabolic measures were assessed at baseline , 3 months , and 6 months . Fifty-three healthy , obese female volunteers ( mean body mass index , 33.6 + /- 0.3 kg/m(2 ) ) were r and omized ; 42 ( 79 % ) completed the trial . Women on both diets reduced calorie consumption by comparable amounts at 3 and 6 months . The very low carbohydrate diet group lost more weight ( 8.5 + /- 1.0 vs. 3.9 + /- 1.0 kg ; P body fat ( 4.8 + /- 0.67 vs. 2.0 + /- 0.75 kg ; P low fat diet group . Mean levels of blood pressure , lipids , fasting glucose , and insulin were within normal ranges in both groups at baseline . Although all of these parameters improved over the course of the study , there were no differences observed between the two diet groups at 3 or 6 months . beta- Hydroxybutyrate increased significantly in the very low carbohydrate group at 3 months ( P = 0.001 ) . Based on these data , a very low carbohydrate diet is more effective than a low fat diet for short-term weight loss and , over 6 months , is not associated with deleterious effects on important cardiovascular risk factors in healthy women",
"BACKGROUND Adipocytokines are associated with insulin resistance and cardiovascular disease and can be modified with weight loss . While we previously demonstrated weight loss and a reduction in leptin in obese adults who followed a low-carbohydrate diet for 6 months , the long-term effects of this diet on adipocytokines are unknown . METHODS 132 obese adults with a body mass index of > or = 35 kg/m2 were r and omized to receive one year of dietary counseling to follow either a low-carbohydrate diet ( reduced by 500 calories/day with Weight , leptin , adiponectin , TNF-alpha , CRP , and insulin were measured at 0 , 6 , and 36 months ( 24 months post-counseling ) . Follow-up data at was collected for 53 participants who returned at 36 months . RESULTS Mean weight change from baseline was not different between the groups at 36 months . Between 6 and 36 months weight was unchanged for LF , while LC appeared to regain weight [ + 4.84 + /- 35.6 kg ( + 3.0 % ) ] . This difference , however , was not significant ( p = 0.08 ) . Leptin was unchanged in LF at both 6 and 36 months . In LC leptin decreased by 8.49 + /- 6.4 ng/mL or 22.7 % at 6 months ( p insulin , adiponectin , TNF-alpha , or CRP between the groups . CONCLUSIONS Favorable changes in leptin that accompany weight loss are not sustained in individuals who followed a low-carbohydrate diet for one year . A low-carbohydrate diet had no significant effect on insulin , adiponectin , TNF-alpha , or CRP compared to a low-fat diet at 36 months",
"CONTEXT : Long-term success in weight loss with dietary treatment has been elusive . OBJECTIVE : To evaluate a diet moderate in fat based on the Mediterranean diet compared to a st and ard low-fat diet for weight loss when both were controlled for energy . DESIGN : A r and omized , prospect i ve 18 month trial in a free-living population . PATIENTS : A total of 101 overweight men and women ( 26.5–46 kg/m2).INTERVENTION : ( 1 ) Moderate-fat diet ( 35 % of energy ) ; ( 2 ) low-fat diet ( 20 % of energy).MAIN OUTCOME MEASUREMENTS : Change in body weight . RESULTS : After 18 months , 31/50 subjects in the moderate-fat group , and 30/51 in the low fat group were available for measurements . In the moderate-fat group , there were mean decreases in body weight of 4.1 kg , body mass index of 1.6 kg/m2 , and waist circumference of 6.9 cm , compared to increases in the low-fat group of 2.9 kg , 1.4 kg/m2 and 2.6 cm , respectively ; P≤0.001 between the groups . The difference in weight change between the groups was 7.0 kg . ( 95 % CI 5.3 , 8.7 ) . Only 20 % ( 10/51 ) of those in the low-fat group were actively participating in the weight loss program after 18 months compared to 54 % ( 27/50 ) in the moderate-fat group , ( P moderate-fat diet group was continued for an additional year . The mean weight loss after 30 months compared to baseline was 3.5 kg ( n=19 , P=0.03 ) . CONCLUSIONS : A moderate-fat , Mediterranean-style diet , controlled in energy , offers an alternative to a low-fat diet with superior long-term participation and adherence , with consequent improvements in weight loss",
"BACKGROUND Low-carbohydrate , ketogenic diets ( LCKD ) are effective for weight loss , but concerns remain regarding cardiovascular risk . The purpose of this study was to determine the effect of an LCKD program on serum lipoprotein subclasses . METHODS This was a r and omized , two-arm clinical trial in an outpatient research clinic involving overweight , hyperlipidemic community volunteers motivated to lose weight . Subjects were r and omized to either an LCKD ( n = 59 ) and nutritional supplementation ( including fish , borage and flaxseed oil ) , or a low-fat , reduced-calorie diet ( LFD , n = 60 ) . The main outcomes were fasting serum lipoprotein subclasses determined by nuclear magnetic resonance analysis . RESULTS The mean age of subjects was 44.9 years , the mean BMI was 34.4 kg/m(2 ) , and 76 % were women . Comparing baseline to 6 months , the LCKD group had significant changes in large VLDL ( -78 % ) , medium VLDL ( -60 % ) , small VLDL ( -57 % ) , LDL particle size ( + 2 % ) , large LDL ( + 54 % ) , medium LDL ( -42 % ) , small LDL ( -78 % ) , HDL particle size ( + 5 % ) , large HDL ( + 21 % ) , and LDL particle concentration ( -11 % ) . Compared with the LFD group , the LCKD group had greater reductions in medium VLDL ( p = 0.01 ) , small VLDL ( p = 0.01 ) and medium LDL ( p = 0.02 ) , and greater increases in VLDL particle size ( p = 0.01 ) , large LDL ( p = 0.004 ) , and HDL particle size ( p = 0.05 ) . CONCLUSIONS The LCKD with nutritional supplementation led to beneficial changes in serum lipid subclasses during weight loss . While the LCKD did not lower total LDL cholesterol , it did result in a shift from small , dense LDL to large , buoyant LDL , which could lower cardiovascular disease risk",
"OBJECTIVES The purpose of this study was to assess the impact of on-treatment triglycerides ( TG ) on coronary heart disease ( CHD ) risk after an acute coronary syndrome ( ACS ) . BACKGROUND The PROVE IT-TIMI ( Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis In Myocardial Infa rct ion ) 22 trial demonstrated that low-density lipoprotein cholesterol ( LDL-C ) evaluated 4,162 patients hospitalized for ACS and r and omized to atorvastatin 80 mg or pravastatin 40 mg daily . The relationship between on-treatment levels of TG and LDL-C and the composite end point of death , myocardial infa rct ion ( MI ) , and recurrent ACS were assessed 30 days after initial presentation . RESULTS Low on-treatment TG ( reduced CHD risk compared with higher TG in univariate analysis ( hazard ratio [ HR ] 0.73 , 95 % confidence interval [ CI ] 0.62 to 0.87 ; p the incidence of death , MI , and recurrent ACS was lower by 1.6 % or 1.4 % after adjustment for LDL-C or non-high-density lipoprotein cholesterol and other covariates ( p Lower CHD risk was also observed with TG low on-treatment TG , LDL-C , and C-reactive protein ( lower risk of recurrent CHD events , lending support to the concept that achieving low TG may be an additional consideration beyond low LDL-C in patients after ACS",
"Previous studies have shown that multiple features of atherogenic dyslipidemia are improved by replacement of dietary carbohydrate with mixed sources of protein and that these lipid and lipoprotein changes are independent of dietary saturated fat content . Because epidemiological evidence suggests that red meat intake may adversely affect cardiovascular disease risk , we tested the effects of replacing dietary carbohydrate with beef protein in the context of high- vs. low-saturated fat intake in 40 healthy men . After a 3-wk baseline diet [ 50 % daily energy ( E ) as carbohydrate , 13 % E as protein , 15 % E as saturated fat ] , participants consumed for 3 wk each in a r and omized crossover design two high-beef diets in which protein replaced carbohydrate ( 31 % E as carbohydrate , 31 % E as protein , with 10 % E as beef protein ) . The high-beef diets differed in saturated fat content ( 8 % E vs. 15 % E with exchange of saturated for monounsaturated fat ) . Two-week washout periods were included following the baseline diet period and between the r and omized diets periods . Plasma TG concentrations were reduced after the 2 lower carbohydrate dietary periods relative to after the baseline diet period and these reductions were independent of saturated fat intake . Plasma total , LDL , and non-HDL cholesterol as well as apoB concentrations were lower after the low-carbohydrate , low-saturated fat diet period than after the low-carbohydrate , high-saturated fat diet period . Given our previous observations with mixed protein diets , the present findings raise the possibility that dietary protein source may modify the effects of saturated fat on atherogenic lipoproteins",
"BACKGROUND AND AIMS The relationship between dietary macronutrient composition and appetite is controversial . We examined the effects of a year-long low-carbohydrate diet compared to a low-fat diet on appetite-related hormones and self-reported change in appetite . METHODS AND RESULTS A total of 148 adults with a body mass index 30 - 45 kg/m(2 ) , who were free of diabetes , cardiovascular disease and chronic kidney disease at baseline were r and omly assigned to either a low-carbohydrate diet ( carbohydrate [ excluding dietary fiber] g/day ; N = 75 ) or a low-fat diet ( , saturated fat ; N = 73 ) . Participants in both groups attended individual and group dietary counseling sessions where they were provided the same behavioral curriculum and advised to maintain baseline levels of physical activity . Appetite and appetite-related hormones were measured at 0 , 3 , 6 and 12 months of intervention . At 12 months , mean changes ( 95 % CI ) in peptide YY were -34.8 pg/mL ( -41.0 to -28.6 ) and in the low-carbohydrate group and -44.2 pg/mL ( -50.4 to -38.0 ) in the low-fat group ( net change : 9.54 pg/mL [ 0.6 to 18.2 ] ; p = 0.036 ) . Approximately 99 % of dietary effects on peptide YY are explained by differences in dietary macronutrient content . There was no difference in change in ghrelin or self-reported change in appetite between the groups . CONCLUSIONS A low-fat diet reduced peptide YY more than a low-carbohydrate diet . These findings suggest that satiety may be better preserved on a low-carbohydrate diet , as compared to a low fat diet . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00609271",
"BACKGROUND AND AIM Very low carbohydrate ad libitum diets have been shown to enhance weight loss without increasing cardiometabolic risk factors but no kilojoule-controlled trials have been conducted relative to no intervention . The aim of this study was to compare the changes in weight and other cardiovascular risk factors in 3 isocaloric energy-restricted diets to no-intervention control after 1 year . METHODS AND RESULTS One hundred and thirteen subjects ( age 47 ± 10 years , BMI 32 ± 6 kg/m(2 ) with one additional cardiovascular risk factor ) were r and omly allocated to one of three isocaloric diets ( VLC-very low carbohydrate , 60 % fat , 4 % carbohydrate , n=30 ; VLF-very low fat , 10 % fat , n = 30 ; HUF-high unsaturated fat , 30 % fat , n = 30 ) with intensive support for 3 months followed by minimal support for 12 months compared to a control group ( no intervention , n = 23 ) . The estimated weight change was -3.0 ± 0.2 kg for VLC , -2.0 ± 0.1 kg for VLF , -3.7 ± 0.01 kg for HUF and 0.8 ± 0.5 kg for controls ( P=0.065 ) . After correcting for baseline values , decreases in body weight and diastolic blood pressure in the diet groups ( -2.9 ± 5.2 ) were significantly different to the increase in the control group ( 0.8 ± 5.0 ) ( P differences in cardiovascular risk factors were observed between the diet groups . CONCLUSION Significant cardiometabolic risk factor reduction was observed equally with VLC , VLF and HUF diets after 15 months , compared to an exacerbation of risk factors in the control group . At a modest level of adherence , 3 months of intensive support on these dietary patterns confer an improvement in cardiometabolic profile compared to no dietary intervention after 15 months",
"BACKGROUND Low-carbohydrate diets are effective for weight reduction in people without diabetes , but there is limited evidence for people with Type 2 diabetes . Aims To assess the impact of a low-carbohydrate diet on body weight , glycated haemoglobin ( HbA(1c ) ) , ketone and lipid levels in diabetic and non-diabetic subjects . METHODS Thirteen Type 2 diabetic subjects ( on diet or metformin ) and 13 non-diabetic subjects were r and omly allocated to either a low-carbohydrate diet ( or = 40 g carbohydrate/day ) or a healthy-eating diet following Diabetes UK nutritional recommendations and were seen monthly for 3 months . Subjects ( 25 % male ) were ( mean + /- sd ) age 52 + /- 9 years , weight 96.3 + /- 16.6 kg , body mass index 35.1 kg/m(2 ) , HbA(1c ) 6.6 + /- 1.1 % , total cholesterol 5.1 + /- 1.1 mmol/l , high-density lipoprotein cholesterol 1.3 + /- 0.4 mmol/l , low-density lipoprotein cholesterol 3.1 + /- 0.9 mmol/l , triglycerides ( geometric mean ) 1.55 ( 1.10 , 2.35 ) mmol/l and ketones range 0.0 - 0.2 mmol/l . RESULTS Analysis was by intention to treat with last observation carried forward . Twenty-two of the participants ( 85 % ) completed the study . Weight loss was greater ( 6.9 vs. 2.1 kg , P = 0.003 ) in the low-carbohydrate group , with no difference in changes in HbA(1c ) , ketone or lipid levels . CONCLUSIONS The diet was equally effective in those with and without diabetes"
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BACKGROUND Fluoxetine is a serotonin reuptake inhibitor indicated for major depression . It is also thought to affect weight control : this seems to happen through appetite changes result ing in decreased food intake and normalisation of unusual eating behaviours . However , the benefit-risk ratio of this off-label medication is unclear . OBJECTIVES To assess the effects of fluoxetine for overweight or obese adults . SEARCH METHODS We search ed the Cochrane Library , MEDLINE , Embase , LILACS , the ICTRP Search Portal and Clinical Trials.gov and World Health Organization ( WHO ) ICTRP Search Portal . The last date of the search was December 2018 for all data bases , to which we applied no language restrictions . SELECTION CRITERIA We included r and omised controlled trials ( RCTs ) comparing the administration of fluoxetine versus placebo , other anti-obesity agents , non-pharmacological therapy or no treatment in overweight or obese adults without depression , mental illness or abnormal eating patterns . DATA COLLECTION AND ANALYSIS Two review authors independently screened abstract s and titles for relevance . Screening for inclusion , data extraction and risk of bias assessment was performed by one author and checked by the second . We assessed trials for the overall certainty of the evidence using the GRADE instrument . For additional information we contacted trial authors by email . We performed r and om-effects meta-analyses and calculated the risk ratio ( RR ) with 95 % confidence intervals ( 95 % CI ) for dichotomous outcomes and the mean difference ( MD ) with 95 % CI for continuous outcomes . MAIN RESULTS We identified 1036 records , scrutinized 52 full-text articles and included 19 completed RCTs ( one trial is awaiting assessment ) . A total of 2216 participants entered the trials , 1280 participants were r and omly assigned to fluoxetine ( 60 mg/d , 40 mg/d , 20 mg/d and 10 mg/d ) and 936 participants were r and omly assigned to various comparison groups ( placebo ; the anti-obesity agents diethylpropion , fenproporex , mazindol , sibutramine , metformin , fenfluramine , dexfenfluramine , fluvoxamine , 5-hydroxy-tryptophan ; no treatment ; and omega-3 gel ) . Within the 19 RCTs there were 56 trial arms . Fifteen trials were parallel RCTs and four were cross-over RCTs . The participants in the included trials were followed up for periods between three weeks and one year . The certainty of the evidence was low or very low : the majority of trials had a high risk of bias in one or more of the risk of bias domains . For our main comparison group - fluoxetine versus placebo - and across all fluoxetine dosages and duration s of treatment , the MD was -2.7 kg ( 95 % CI -4 to -1.4 ; P The MD in body mass index ( BMI ) reduction across all fluoxetine dosages compared with placebo was -1.1 kg/m² ( 95 % CI -3.7 to 1.4 ; 3 trials , 97 participants ; very low certainty evidence ) . Only nine placebo-controlled trials reported adverse events . A total of 399 out of 627 participants ( 63.6 % ) receiving fluoxetine compared with 352 out of 626 participants ( 56.2 % ) receiving placebo experienced an adverse event . R and om-effects meta- analysis showed an increase in the risk of having at least one adverse event of any type in the fluoxetine groups compared with placebo ( RR 1.18 , 95 % CI 0.99 to 1.42 ; P = 0.07 ; 9 trials , 1253 participants ; low-certainty evidence ) . The 95 % prediction interval ranged between 0.74 and 1.88 . Following fluoxetine treatment the adverse events of dizziness , drowsiness , fatigue , insomnia and nausea were observed approximately twice as often compared to placebo . A total of 15 out of 197 participants ( 7.6 % ) receiving fluoxetine compared with 12 out of 196 participants ( 6.1 % ) receiving placebo experienced depression . The RR across all fluoxetine doses compared with placebo was 1.20 ( 95 % CI 0.57 to 2.52 ; P = 0.62 ; 3 trials , 393 participants ; very low certainty evidence ) . All-cause mortality , health-related quality of life and socioeconomic effects were not reported . The comparisons of fluoxetine with other anti-obesity agents ( 3 trials , 234 participants ) , omega-3 gel ( 1 trial , 48 participants ) and no treatment ( 1 trial , 60 participants ) showed inconclusive results ( very low certainty evidence ) . AUTHORS ' CONCLUSIONS Low-certainty evidence suggests that off-label fluoxetine may decrease weight compared with placebo . However , low-certainty evidence suggests an increase in the risk for dizziness , drowsiness , fatigue , insomnia and nausea following fluoxetine treatment
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"Health risks associated with obesity are well known and compliance with st and ard regimens for weight reduction is frequently unsatisfactory . Fluoxetine is a specific inhibitor of serotonin re-uptake with very minimal affinity for serotonergic or other receptors . It causes a decrement in food intake in animals . Placebo or fluoxetine was given for up to 8 weeks to non-depressed , otherwise healthy , obese patients given minimal dietary advice . Patients given fluoxetine lost 4.5 + /- 4.0 kg , significantly more than those receiving placebo , 1.4 + /- 0.1 kg . The weight loss was correlated with the degree of obesity in the fluoxetine-treated patients . Asthenia was the only event reported significantly more frequently by fluoxetine-treated patients ( 23 percent ) than by those treated with placebo ( 3 percent ) ( P less than 0.01 ) . Fluoxetine appears to be safe and effective in inducing weight loss over periods of up to 8 weeks",
"Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged",
"Background : Obesity is a very important risk factor for cardiovascular disease , type 2 diabetes mellitus , hypertension , osteoarthritis , fatty liver , metabolic syndrome and respiratory problems . Many weight-reducing drugs can not be used in obese patients because of numerous complications . Fluoxetine , an antidepressant , and metformin , an antidiabetic drug , reduce weight as their side effect , but the potency of each drug is not always enough . Here , we studied the effects of combination therapy of them for weight reduction in obese women . Material s and methods : This study was design ed as an open , prospect i ve , controlled clinical trial . Obese and overweight patients referred to obesity clinics were first put under a diet and behavior therapy education program before being invited to this study . The patients who accepted drug therapy were put in the case group . Those who did not accept drug therapy were put in the control group . Fluoxetine , 20 mg daily , and metformin , 500 mg three times daily , were prescribed to the participants . Weight and body mass index ( BMI ) changes within case and control groups were analyzed by paired t-tests and between groups by t-testing . Side effects were evaluated by interview and question naire . Subjects : Two hundred and three patients were referred to obesity clinics . Of these , 177 were female with 91 being volunteers for this study . Of this 91 , 66 were in the case group and 25 in the control group . Results : In a 6.68-month period , a 7.89 kg decrease in weight ( 9.32 % ) and a 3.43 U decrease in BMI ( 10.14 % ) were observed in participants of the case group that was statistically significant ( P decrease in weight ( 0.52 % ) and a 0.11 U decrease in BMI ( 0.42 % ) . This was not significant . No serious side effects of the drugs were observed in the case group . Conclusion : This open-label pilot study of combination therapy of metformin and fluoxetine gave encouraging weight reduction , and these results suggest the need for a r and omized double-blind clinical trial comparing the two components and the combination to placebo",
"PURPOSE We aim ed to assess the impact of spin ( ie , reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results ) on the interpretation of results of abstract s of r and omized controlled trials ( RCTs ) in the field of cancer . METHODS We performed a two-arm , parallel-group RCT . We selected a sample of published RCTs with statistically nonsignificant primary outcome and with spin in the abstract conclusion . Two versions of these abstract s were used-the original with spin and a rewritten version without spin . Participants were clinician corresponding authors of articles reporting RCTs , investigators of trials , and review ers of French national grants . The primary outcome was clinicians ' interpretation of the beneficial effect of the experimental treatment ( 0 to 10 scale ) . Participants were blinded to study hypothesis . RESULTS Three hundred clinicians were r and omly assigned using a Web-based system ; 150 clinicians assessed an abstract with spin and 150 assessed an abstract without spin . For abstract s with spin , the experimental treatment was rated as being more beneficial ( mean difference , 0.71 ; 95 % CI , 0.07 to 1.35 ; P = .030 ) , the trial was rated as being less rigorous ( mean difference , -0.59 ; 95 % CI , -1.13 to 0.05 ; P = .034 ) , and clinicians were more interested in reading the full-text article ( mean difference , 0.77 ; 95 % CI , 0.08 to 1.47 ; P = .029 ) . There was no statistically significant difference in the clinicians ' rating of the importance of the study or the need to run another trial . CONCLUSION Spin in abstract s can have an impact on clinicians ' interpretation of the trial results",
"Humans lose weight when administered fluoxetine , an inhibitor of serotonin reuptake by nerve terminals . To determine whether increased energy expenditure contributes to this weight loss we admitted 20 nondepressed obese women to a metabolic unit where they were r and omly assigned to 3 wk of a 1.76-MJ/d formula diet and either 60 mg fluoxetine/d or a placebo . Resting energy expenditure of the control subjects fell below normal after 5.6 + /- 0.6 d of energy restriction , whereas that of the fluoxetine-treated subjects increased by 4.4 + /- 1.8 % ( P resting energy expenditure then reversed and fell below normal after 9.8 + /- 0.9 d of energy restriction . Basal body temperature of the control subjects decreased insignificantly during the period of energy restriction , but that of the fluoxetine-treated subjects increased by 0.28 + /- 0.10 degrees C ( P Urinary norepinephrine excretion and the serum triiodothyronine concentration decreased equally in both groups . Despite identical energy intakes and equal nitrogen balance , the fluoxetine-treated subjects lost weight faster than the control subjects during the final week of energy restriction ( P energy expenditure by increasing basal body temperature",
" Forty-five obese subjects with a mean weight of 102.9 kg and a body mass index ( in kg/m2 ) of 37.6 were r and omly assigned to a fluoxetine-diet group ( n = 23 ) or a placebo-diet group ( n = 22 ) for 52 wk . At week 29 , 14 subjects on fluoxetine who completed the study attained their maximum weight loss of 12.4 kg , an amount significantly greater than the maximum weight loss of 4.5 kg for the 16 on placebo who completed the study . The fluoxetine group 's significantly greater mean weight loss continued through week 45 . However , those on fluoxetine regained a mean of 4.2 kg from their lowest weight ( P less than 0.001 ) whereas the placebo group did not . By the end of the study , each group weighed significantly less than they did at baseline ( fluoxetine : -8.2 kg ; placebo : -4.5 kg ; P less than 0.05 ) although the difference between groups was no longer significant ( P greater than 0.05 ) . Several factors were considered as possible causes for the regain with fluoxetine",
"OBJECTIVE The study aims to provide information about variance components of psychosocial outcomes : within and between-participant variance , within-participant correlation and for cluster r and omised trials , the intra-cluster correlation ( ICC ) and , also , to demonstrate how estimates of these variance components and ICCs can be used to design r and omised trials and cluster r and omised trials . METHOD Data from 15 longitudinal multi-centre psycho-oncology studies were analysed , and variance components including ICCs were estimated . Studies with psychosocial outcomes that had at least one measurement post-baseline including individual r and omised controlled trials , cluster r and omised trials and observational studies were included . RESULTS Variance components and ICCs from 87 outcome measures were estimated . The unadjusted , single timepoint ( first post-baseline ) ICCs ranged from 0 to 0.16 , with a median value of 0.022 and inter-quartile range 0 to 0.0605 . The longitudinal ICCs ranged from 0 to 0.09 with a median value of 0.0007 and inter-quartile range 0 to 0.018 . CONCLUSIONS Although the magnitude of variance components and ICCs used for sample -size calculation can not be known in advance of the study , published estimates can help reduce the uncertainty in sample -size calculations . Psycho-oncology research ers should be conservative in their sample -size calculations and use approaches that improve efficiency in their design and analysis",
"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",
"AIMS Nicotine replacement therapy ( NRT ) is an established aid in stopping smoking , while the role of antidepressants remains uncertain . Antidepressants added to NRT might improve abstinence rates . Our aim was to determine the efficacy of nicotine inhaler and fluoxetine vs. nicotine inhaler and placebo in attempts to quit smoking . DESIGN A r and omized , double-blind , placebo-controlled trial . SETTING A smoker 's cessation clinic . PARTICIPANTS One hundred volunteers smoking 10 cigarettes/day or more . INTERVENTIONS Subjects were instructed to start taking a daily dose of 10 mg of fluoxetine or placebo 16 days before stopping smoking , then 20 mg 10 days before quitting , continuing for up to at least 3 months . Subjects were instructed to use 6 - 12 units per day of nicotine inhalers after stopping smoking for up to 6 months . MEASUREMENTS Continuous abstinence rates recorded at various time points up to 12 months from the quit date . FINDINGS The sustained abstinence rate for the inhaler-fluoxetine group was 54 % , 40 % , 29 % and 21 % after 1.5 , 3 , 6 and 12 months , respectively , compared to 48 % , 40 % , 32 % and 23 % for the inhaler-placebo group . The differences were not significant at any time point . Abstinence up to 3 months was more likely in older smokers , those with a lower Beck Depression Inventory Score ( BDI ) , lower Fagerström Test of Nicotine Dependence ( FTND ) score and no history of alcoholism . Fluoxetine appeared to increase abstinence rates among high BDI smokers compared to high BDI smokers assigned placebo . Serum levels of nicotine during treatment in the inhaler-fluoxetine group were lower than in the inhaler-placebo group so that fluoxetine may have reduced inhaler use through a common site of action . CONCLUSIONS We found no evidence that fluoxetine treatment when used as an adjunct to NRT in unselected smokers is effective , but there may be an advantage to using it in depressed smokers",
"OBJECTIVE To compare the effectiveness of two interventions in the treatment of obese patients : hypocaloric diet and hypocaloric diet plus serotoninergic medication . DESIGN R and omised clinical trial . SETTING Primary Care . Out-patient Endocrinology clinic . PATIENTS The trial included 60 obese adults , assigned at r and om to two groups of 30 each . Both groups were comparable for sex , age , weight and Body Mass Index . Weight controls were performed at 2 , 4 and 6 months . RESULTS There were no significant differences in weight losses at the times studied ( 2 , 4 and 6 months ) between the Control ( Hypocaloric diet ) and Study ( Hypocaloric diet plus medication ) groups . There were significant weight losses in both groups analysed between 2 and 4 months , with a Body Mass Index which went down from 36.2 to 34.12 and from 35.52 to 33.57 ( p obese patients between a hypocaloric diet supplemented by serotoninergic medication and a hypocaloric diet",
"CONTEXT As of 2005 , the International Committee of Medical Journal Editors required investigators to register their trials prior to participant enrollment as a precondition for publishing the trial 's findings in member journals . OBJECTIVE To assess the proportion of registered trials with results recently published in journals with high impact factors ; to compare the primary outcomes specified in trial registries with those reported in the published articles ; and to determine whether primary outcome reporting bias favored significant outcomes . DATA SOURCES AND STUDY SELECTION MEDLINE via PubMed was search ed for reports of r and omized controlled trials ( RCTs ) in 3 medical areas ( cardiology , rheumatology , and gastroenterology ) indexed in 2008 in the 10 general medical journals and specialty journals with the highest impact factors . DATA EXTRACTION For each included article , we obtained the trial registration information using a st and ardized data extraction form . RESULTS Of the 323 included trials , 147 ( 45.5 % ) were adequately registered ( ie , registered before the end of the trial , with the primary outcome clearly specified ) . Trial registration was lacking for 89 published reports ( 27.6 % ) , 45 trials ( 13.9 % ) were registered after the completion of the study , 39 ( 12 % ) were registered with no or an unclear description of the primary outcome , and 3 ( 0.9 % ) were registered after the completion of the study and had an unclear description of the primary outcome . Among articles with trials adequately registered , 31 % ( 46 of 147 ) showed some evidence of discrepancies between the outcomes registered and the outcomes published . The influence of these discrepancies could be assessed in only half of them and in these statistically significant results were favored in 82.6 % ( 19 of 23 ) . CONCLUSION Comparison of the primary outcomes of RCTs registered with their subsequent publication indicated that selective outcome reporting is prevalent",
"Pharmacologic measures which increase serotonergic activity in the brain decrease food consumption and lead to decreased weight in animals . Fluoxetine , an inhibitor of serotonin reuptake , decreases food intake in animals and is associated with weight loss in depressed and otherwise healthy obese patients . To determine the most effective daily fixed dose which causes weight loss in nondepressed obese patients , fluoxetine ( 10 , 20 , 40 or 60 mg ) or placebo was administered once daily for 8 weeks to 655 patients consisting primarily of women ( mean age 40 years , mean weight 95 kg ) . Diet and activity were not controlled . The placebo-treated patients lost 0.6 + /- 2.3 kg . With the 60-mg fluoxetine dose , patients lost an average of 4.0 + /- 3.9 kg ( P less than 0.001 ) , with intermediate responses at the lower doses . Weight loss was proportional to the initial body mass index ( weight/height squared ) . There were no statistically significant differences between any fluoxetine treatment group and placebo for discontinuations from the study . There were statistically significant dose-dependent increases in reports of asthenia , somnolence and sweating . Thus , fluoxetine 60 mg daily appears to be potentially effective for use in weight reduction",
"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",
"Obesity is a major health care concern because of its associated medical complications and increased mortality . Despite a myriad of short-term weight loss strategies and the motivation of improving health , patients have difficulty maintaining reduced weight . Pharmacologic agents , such as fluoxetine , a selective serotonin uptake inhibitor , have been investigated as adjunctive therapy to st and ard weight management programs . Extended therapy with fluoxetine has demonstrated clinical ly meaningful benefits on weight loss and obesity-associated medical conditions in double-blind placebo-controlled studies . However , the magnitude of these benefits for individuals vary . Such findings are consistent with the belief that the obesity syndrome has differing etiologies . Accordingly not all patients are likely to benefit from a particular therapy . Studies should identify patient subgroups that are more likely to respond to a specific therapy . In this study of 719 fluoxetine-treated and 722 placebo treated patients in four multicenter , r and omized , double-blind , long-term clinical trials , we investigated possible predictors of a beneficial long-term outcome from fluoxetine therapy . Patients ' age , current smoking activity , and baseline uric acid concentration were predictors of a meaningful long-term treatment effect . Further review of the weight loss patterns of patients achieving long-term success provided the basis for a treatment monitor . Use of the predictors and the treatment monitor are strategies to maximize the benefits of therapy through improved patient selection and monitoring during a therapeutic program",
"Data from two large , fixed-dose trials support the efficacy of a fixed 20 mg/day dose of fluoxetine in the treatment of depression . Data pooled from these two studies suggest a dose relationship for adverse events during fluoxetine therapy . At a fixed 20 mg/day dose , only nausea and insomnia were reported by a significantly greater percentage of patients ( p less than .05 ) than those treated with placebo . However , at 60 mg/day , nausea , anxiety , dizziness , and insomnia were reported by a significantly greater percentage of patients ( p less than .05 ) than those treated with placebo . The potential relationship of response rate [ Hamilton Rating Scale for Depression ( HAM-D ) total decrease greater than or equal to 50 % ] to plasma concentrations of fluoxetine , norfluoxetine , and fluoxetine plus norfluoxetine was evaluated in one study which excluded early responders ( less than or equal to 3 weeks of therapy ) . No significant relationship was found . Furthermore , adverse events were not related to plasma concentrations",
"Context : No long-term studies have compared central ly acting drugs for treating obesity . Objective : To compare the efficacy and safety of diethylpropion ( DEP ) , fenproporex ( FEN ) , mazindol ( MZD ) , fluoxetine ( FXT ) and sibutramine ( SIB ) in promoting weight loss . Design and Setting : A prospect i ve , r and omized , placebo (PCB)-controlled study conducted at a single academic institution . Patients : A total of 174 obese premenopausal women . Intervention : Participants r and omly received DEP 75 mg ( n=28 ) , FEN 25 mg ( n=29 ) , MZD 2 mg ( n=29 ) , SIB 15 mg ( n=30 ) , FXT 20 mg ( n=29 ) or PCB ( n=29 ) daily over 52 weeks . Diet and physical activity were encouraged . Main Outcome Measures : The primary endpoints were changes in body weight and the proportion of women who achieved at least 5 % weight loss by week 52 in the intent-to-treat population . Other measurements included anthropometry , safety , metabolic and cardiovascular parameters . Results : Weight loss was greater than PCB ( −3.1±4.3 kg ) with DEP ( −10.0±6.4 kg ; P more adverse events compared with PCB ( P , constipation was more prevalent with DEP , SIB and MZD ( P ) ; anxiety was more prevalent with DEP ( P=0.01 ) ; and irritability occurred more frequently with DEP and FEN ( P=0.02 ) . Significant improvements in the depression and anxiety scores , binge-eating episodes and quality of life correlated with weight loss . CONCLUSION : The central ly acting drugs DEP , FEN , MZD and SIB were more effective than PCB in promoting weight loss in obese premenopausal women , with a satisfactory benefit – risk profile",
"Smoking cessation attempts are often complicated by dysphoria/depression , weight gain , craving , and other nicotine withdrawal symptoms . Fluoxetine 's antidepressant and anorectant properties , along with its capacity to attenuate compulsive behavior , suggest that this medication might facilitate smoking cessation treatment . We examined the effect of fluoxetine on smoking cessation in the context of a program that included group cognitive-behavioral therapy ( six weeks ) and transdermal nicotine patch(ten weeks ) . In a double-blind r and omized trial of fluoxetine for smoking cessation , 150 daily smokers were assigned to placebo ( n=48 ) , 20 mg ( n=51 ) , or 40 mg fluoxetine ( n=51 ) . Fluoxetine did not significantly improve smoking cessation rates , either for those with or without major depressive disorder(MDD)histories or elevated current depression . Our results suggest that fluoxetine may moderate withdrawal symptoms , even if that was not manifested in improved smoking cessation rates . Our results , however , clearly favor the use of fluoxetine if weight gain is a major clinical obstacle to smoking cessation",
"Because current weight-reduction treatments have considerable recidivism , a therapy that could help patients maintain weight loss would be of benefit . A six-center , r and omized , double-blind trial compared the effects of the specific serotonin uptake inhibitor , fluoxetine hydrochloride , and placebo on maintenance of weight loss . Obese out patients who had lost > or = 3.6 kg after 8 weeks of single-blind fluoxetine 60 mg/day in the qualification phase ( N=317 [ 70.4 % of patients entered ] ; mean + /- st and ard deviation [ SD ] weight loss , 6.8 + /- 2.8 kg ) were r and omly assigned to fluoxetine 20 mg/day ( N=104 ) , fluoxetine 60 mg/day ( N=106 ) , or placebo ( N=107 ) for 40 weeks ( maintenance phase ) . Patients received minimal nutrition/dietary counseling . Qualification phase clinic visits were biweekly ; maintenance phase visits were monthly for 4 months , then bimonthly for 6 months . Patients treated with fluoxetine 60 mg/day continued to lose weight for 8 additional weeks ( 16 weeks total ; maximum mean + /- SD weight loss , 7.2 + /- 4.6 kg ) ; those treated with fluoxetine 20 mg/day or placebo began to regain weight . Mean weights remained below baseline values at week 48 ( all groups ) ; treatment differences were not statistically significant . Study completion rates were comparable ( fluoxetine 20 mg/day , 67.3 % ; fluoxetine 60 mg/day , 56.6 % ; placebo , 67.3 % ; p = 0.175 ) . Among commonly reported adverse events ( > 10 % incidence ) , only asthenia was reported statistically significantly ( p fluoxetine than with placebo . Few patients discontinued for any single adverse event . Fluoxetine 60 mg/day was effective for a longer period than fluoxetine 20 mg/day or placebo in maintaining weight loss . Overall , fluoxetine was safe and well tolerated",
"BACKGROUND There has been a paucity of well- design ed studies comparing selective serotonin reuptake inhibitor ( SSRI ) medications in the treatment of depression in the elderly . This multicenter study was design ed to examine the efficacy and safety of sertraline and fluoxetine in depressed elderly out patients . A secondary objective was to examine the effects of SSRI treatment on quality of life and cognitive function . METHOD Two hundred thirty-six out patients 60 years of age and older who met DSM-III-R criteria for major depressive disorder received 1 week of single-blind placebo before being r and omly assigned to 12 weeks of double-blind , parallel-group treatment with flexible daily doses of either sertraline ( range , 50 - 100 mg ) or fluoxetine ( range , 20 - 40 mg ) . Primary efficacy measures consisted of the 24-item Hamilton Rating Scale for Depression and Clinical Global Impressions scale ratings . Secondary outcome assessment s included clinician- and patient-rated measures of depression symptoms and factors , cognitive functioning , and quality of life , as well as plasma drug concentrations , which were correlated with clinical response . RESULTS Both drugs produced a similarly positive response on the primary efficacy measures , with 12-week responder rates of 73 % for sertraline and 71 % for fluoxetine . Sertraline-treated patients showed statistically greater cognitive improvement on several measures . Both drugs were safe and well tolerated . CONCLUSION Data indicate that both drugs are effective antidepressants for the treatment of depressed elderly out patients . Differences in cognitive performance effects deserve further investigation",
"In this paper we investigated the effect of fluoxetine ( 60 mg/d ) on serum lipids , glucose and insulin concentrations and blood pressure by means of a r and omized , double-blind placebo controlled trial . Thirty-eight overweight ( BMI : 26 - 30 kg/m2 ) , nondiabetic , nonhypertensive men with an abdominal fat distribution ( waist/hip ratio : > 0.97 ) received dietary advice and placebo or fluoxetine for 12 weeks . The changes in serum parameters and blood pressure in the fluoxetine treated group were not different from the placebo treated group , despite a significantly larger weight loss in the fluoxetine group . In both groups serum total-cholesterol concentrations , serum LDL-cholesterol concentrations and the HDL/LDL ratio were significantly improved after treatment . Reductions in fasting glucose concentration and systolic blood pressure were only significant in the placebo group . A reduction of serum triglycerides and an increase of HDL-cholesterol were found in the fluoxetine treated group . In the total study population the changes in serum lipids seemed to be more strongly related to the change in total body fat or subcutaneous abdominal fat ( assessed by MRI ) compared to the change in visceral fat . The improvement of most of the serum lipids was related to the change in total body fat independent of the mechanism for attaining this fat loss . Our results indicate that fluoxetine treatment has no specific effect beyond that expected for weight loss on serum lipid , glucose and insulin concentrations , and blood pressure in overweight men",
"OBJECTIVE Fluoxetine has been associated with weight loss during acute treatment , but no controlled studies of weight change during long-term treatment with fluoxetine or other selective serotonin reuptake inhibitors have been reported . Weights were assessed for patients whose depressive symptoms had disappeared with acute fluoxetine treatment . Patients were then r and omly assigned to continuation treatment with fluoxetine or placebo . METHOD Patients whose illness had remitted after 12 weeks of treatment with fluoxetine , 20 mg/day , were r and omly assigned to receive up to 38 weeks of treatment with fluoxetine or placebo . Weight was assessed at each visit . Change in weight was analyzed during the initial 12 weeks of acute treatment and after 14 , 26 , and 38 weeks . Relationships between weight change and body mass index and between weight change and appetite change were assessed . RESULTS During the initial 4 weeks of therapy , a mean absolute weight decrease of 0.4 kg was observed for all patients . Among patients who completed 50 weeks of therapy , the mean absolute weight increase during continuation treatment was similar for both the placebo- and fluoxetine-treated groups . Weight increase was not related to initial body mass index but was related to both poor appetite at study entry and to improvement in appetite after recovery . No patients discontinued therapy because of weight gain . CONCLUSIONS Acute therapy with fluoxetine is associated with modest weight loss . After remission of depressive symptoms , weight gain for patients taking fluoxetine for longer periods is not different from that for patients taking placebo and is most likely related to recovery from depression",
"Obesity is one of the most important health problems , which many people suffer from it . As a chronic disease , it is a precipitating factor for many medical conditions like hypertension , diabetes mellitus , hyperlipidemia , coronary artery disease , sleep apnea syndrome and some malignancies ( breast , uterus , prostate and colon carcinoma ) . With attention to this fact that obesity is an independent risk factor associated with significant increase in morbidity and mortality , treatment of overweight individuals is very important . One of the medications for short-term weight loss is fluoxetin . In this clinical trial study , fluoxetin effect on weight loss induction during 8 weeks was investigated . 201 cases with BMI between 25–42 were selected r and omly ( 113 female and 88 male ) and all received fluoxetine ( 40 mg daily ) for 8 weeks . Measurement was carried out after the 4th and 8th week of administration and 4 weeks after end of treatment . Management of 9 cases ( 4 due to weight gain and 5 due to headache ) were discontinued after 4 weeks of treatment . Data assessment s were performed using t-test and SPSS program . Mean body weight at first visit was 89.32±13.30 kg . At the 4th , 8th week of treatment and 4 weeks after study , the mean body weight of cases reached 86.09±13.27 ( p=0.00 ) , 82.69±11.31 ( p=0.00 ) and 81.97±13.26 ( p=0.00 ) respectively . Mean BMI at first visit was 34.90±5.20kg/m2 . At 4th , 8th weeks of treatment it was 33.72±5.20kg/m2 and 32.40±5.18kg/m2 respectively . Mean weight loss at 4th and 8th weeks of treatment was 3.24 kg and 6.67 kg respectively without any weight gain at the end of the 4th week after discontinuation of the drug . Fluoxetine is an effective , well-tolerated and relatively safe drug for short-term treatment of obesity",
"One hundred and eight patients with major depression were treated with fluoxetine 20 mg/day for 3 weeks . Patients who failed to respond to this open-label treatment were r and omly assigned either to receive fluoxetine 60 mg/day for 5 weeks or to continue treatment with fluoxetine 20 mg/day for an additional 5 weeks . Both treatment groups demonstrated a statistically significant reduction in depressive symptoms , indicating that continued treatment with low-dose fluoxetine may be as effective as an increase in dose in achieving a favorable clinical outcome",
"Eleven healthy male subjects of normal body weight received either 60 mg of the 5-HT re-uptake inhibitor fluoxetine ( FXT ) or matching placebo daily for two weeks , with a minimum one month wash-out period between treatments . Subjects attended on days 1 , 8 and 15 from 08.50 h to 15.15 h in each treatment period when food and fluid intake , body weight , pulse and blood pressure , pupil diameter and plasma levels of FXT and NorFXT were measured and visual analogue scales ( VAS ) for subjective ratings of hunger , satiety , thirst , mood , arousal , nausea and gastric discomfort were completed . The trial was of a double-blind r and omised crossover design , each subject acting as his own control . FXT reduced food intake by 15.7 per cent on day 1 ; by 12.6 per cent on day 8 but not on day 15 . Hunger ratings were lowered by FXT on days 8 and 15 but not on day 1 . Subjects were less thirsty when taking FXT but there was no concomitant reduction in fluid intake . FXT produced some mydriasis and slowed heart rate . In two weeks treatment with FXT there was a statistically significant weight loss of 1.07 kg compared to a mean weight gain of 0.15 kg on placebo . The incidence of reported side effects was low , drowsiness and stomach discomfort were reported by some subjects on days 8 and 15",
"A key component of the Cochrane Collaboration 's risk of bias tool for critically evaluating r and omised trials is the consideration of whether baseline characteristics of the treatment groups being compared are systematic ally different . Considered under the domain of ' selection bias ' , this is currently evaluated by looking at the methods of r and omisation and specifically at the generation of the r and omised allocation sequence and the concealment of this sequence during the process of r and omisation . Assessment of the actual similarity of baseline variables across groups in demographic and clinical characteristics is seldom performed . Even when performed , the link with selection bias is sometimes not considered . Methods of r and omisation and allocation concealment are often poorly reported in published trials , yet baseline data tables are presented in a large majority of trial reports . In this article , we propose that assessment of trial baseline data should form a key and prominent part of selection bias judgements when using the risk of bias tool . We outline the possible benefits from using this approach , including reduced uncertainty in systematic review conclusions , reduced risk of chance findings being ascribed to treatment effects and better use of available evidence by a more considered approach to evaluating studies using imperfect r and omisation and allocation methods",
"Frequent mood and sleep disorders and increased appetite leading to obesity are observed in postmenopausal women . Due to the limitations of hormone replacement therapy the research ers look for other treatment regimes . The aim of the study was to evaluate the efficacy of fluoxetine and melatonin in the treatment of these disorders . The study included 64 overweight postmenopausal women , aged 54 - 65 years , with increased appetite . They were r and omly assigned in 2 groups . In group I ( n = 30 ) fluoxetine ( 20 mg in the morning ) and placebo ( in the evening ) were administered for 24 weeks . Group II ( n = 34 ) received fluoxetine ( 20 mg in the morning ) and melatonin ( 5 mg in the evening ) in the same period of time . Hamilton anxiety rating scale ( HARS ) , Beck depression scale ( BDI ) , the insomnia severity index ( ISI ) and body mass index ( BMI ) were used to assess the health status and the treatment efficacy . After 24 weeks , comparable and statistically significant reduction in the level of anxiety and depression was obtained in both groups . In group I , the ISI decreased from 14.9 ± 2.5 points to 10.9 ± 1.9 points ( P no reduction in BMI was achieved whereas in group II this index decreased from 30.9 ± 3.1 to 26.3 ± 3.2 ( P of fluoxetine and melatonin was useful option to treat mood , sleep and appetite disorders in postmenopausal women",
"BACKGROUND The effect of extended anti-depressant treatment on weight has been poorly investigated . Also unknown is whether different compounds have differential effects . The aim of the present study was to assess changes in weight in obsessive-compulsive disorder ( OCD ) patients treated for 2.5 years with clomipramine or selective serotonin reuptake inhibitors . METHOD 138 DSM-IV OCD patients who responded to 6-month acute treatment at the Mood and Anxiety Disorders Unit , Department of Neuroscience , University of Turin , Italy , were followed-up for 2 years while receiving open-label clomipramine , citalopram , fluoxetine , fluvoxamine , paroxetine , or sertraline . Patients were consecutively recruited and followed from May 1998 to March 2003 . The mean percentage change in weight was compared for each group , as was the proportion of patients who had a > or = 7 % weight increase from baseline . RESULTS At the end of the 2.5-year study period , patients had gained a mean of 2.5 % of their body weight with respect to baseline ( 1.58 kg ) ; 14.5 % of the total sample experienced a significant ( > or = 7 % ) weight increase . Within each but the fluoxetine treatment group , paired t tests showed a significant increase in weight from baseline to final visit . Analysis of variance showed a significant difference between treatment groups ( p = .009 ) , with clomipramine being associated with the highest weight increase and fluoxetine and sertraline with the lowest . A higher proportion of clomipramine-treated patients ( 34.8 % ) gained > or = 7 % in weight as compared with sertraline and fluoxetine , which accounted for the lowest percentage of patients with a significant weight gain ( 4.5 % and 8.7 % , respectively ) , although this difference was not statistically significant . CONCLUSION Risk of weight gain during extended serotonin reuptake inhibitor treatment for OCD differs depending on which compound is used . The differences among antiobsessive drugs may affect compliance with medication and health risks",
"OBJECTIVE To report second-year results from the 2-year maintenance phase of a long-term study to evaluate the efficacy and safety of venlafaxine extended release ( ER ) in preventing recurrence of depression . METHOD Out patients with recurrent unipolar depression ( DSM-IV criteria ; N = 1096 ) were r and omly assigned in a 3:1 ratio to 10 weeks of treatment with venlafaxine ER or fluoxetine . Responders ( 17-item Hamilton Rating Scale for Depression [ HAM-D(17 ) ] total score or= 50 % decrease from baseline ) entered a 6-month , double-blind continuation phase on the same medication . Continuation-phase responders were enrolled into maintenance treatment consisting of 2 consecutive 12-month phases . At the start of each maintenance phase , venlafaxine ER responders were r and omly assigned to receive double-blind treatment with venlafaxine ER or placebo , and fluoxetine responders were continued for each period . The second 12-month maintenance phase compared the time to recurrence of depression with venlafaxine ER ( 75 to 300 mg/day ) versus placebo as the primary efficacy measure . The primary definition of recurrence was a HAM-D(17 ) total score > 12 and time to recurrence was evaluated using Kaplan-Meier methods and compared between the venlafaxine ER and placebo groups using log-rank tests . Secondary outcome measures included rates of response and remission ( defined as HAM-D(17 ) cumulative probabilities of recurrence through 12 months in the venlafaxine ER ( N = 43 ) and placebo ( N = 40 ) groups were 8.0 % ( 95 % CI = 0.0 to 16.8 ) and 44.8 % ( 95 % CI = 27.6 to 62.0 ) , respectively ( p rate of response or remission was significantly higher in the venlafaxine ER group ( 93 % ) than in the placebo group ( 63 % ; p = .002 ) . Overall discontinuation rates were 28 % and 63 % in the venlafaxine ER and placebo groups , respectively . Adverse events were the primary reason for discontinuation for 1 patient ( 2 % ) in the venlafax-ine ER group and 4 ( 10 % ) in the placebo group . An analysis of the combined maintenance phases , which compared the risk of recurrence over 24 months for patients assigned to venlafaxine ER ( N = 129 ) or placebo ( N = 129 ) for the first maintenance phase , showed a significantly greater cumulative probability of recurrence through 24 months for the placebo group ( 47.3 % [ 95 % CI = 36.4 to 58.2 ] ) than for the venlafaxine ER group ( 28.5 % [ 95 % CI = 18.3 to 38.7 ] ; p = .005 ) . CONCLUSION In this study , an additional 12 months of maintenance therapy with venlafaxine ER was effective in preventing recurrence of depression in patients who had been responders to venlafaxine ER after acute ( 10 weeks ) , continuation ( 6 months ) , and initial maintenance ( 12 months ) therapy . TRIAL REGISTRATION Clinical Trials.gov identifier NCT00046020 ( http://www . clinical trials.gov )",
"Twelve nondepressed healthy female obese subjects ( BMI > 30 kg/m2 ) took part in a study which conformed to a double-blind r and omized crossover design . Each subject acted as her own control across 2 weeks of treatment with either 60 mg of the 5-HT reuptake inhibitor fluoxetine or matching placebo . On days 7 and 14 of both treatment phases subjects were provided with fixed energy lunch meals high in either CHO or fat . The effect of these meals on satiety during the fluoxetine and placebo phases was assessed by a battery of procedures . Subjects felt less hungry after consuming the high CHO meal than after consuming the high-fat meal . They also felt less hungry when taking fluoxetine than when taking the placebo . Analysis of energy intake from the test meal revealed a main effect of prior lunch meal type ( high CHO or high fat ) and a main effect of drug treatment . Subjects consumed an average of 574 kcal following the high CHO meal compared to 689 kcal following the high-fat meal . Subjects also consumed an average of 532 kcal when taking fluoxetine compared to 730 kcal when taking the placebo . Fluoxetine did not exert any significant effects on macronutrient selection . Mean daily energy intake , calculated from food diary records , was 1881 kcal when subjects were taking the placebo compared to 1460 kcal when taking fluoxetine ( a reduction of 22.4 % ) . Fluoxetine treatment produced a significant weight loss of 1.97 kg over the two weeks of treatment compared to a weight loss of only 0.04 kg on placebo",
"This study assessed the effect of fluoxetine 20 mg/day on weight loss in older patients treated for major depression in a multicenter , double-blind placebo-controlled , 6-week clinical trial . Thirty U.S. outpatient clinics affiliated with psychiatric programs participated in the study that involved 671 medically stable out patients at least 60 years old who had normal cognition and met DSM-III-R criteria for major depression . Weight was recorded at weekly visits . As a measure of adiposity , patients were categorized into two groups , high and low/normal body mass index ( BMI ) groups . Analyses were done for each group . The high BMI group , but not the low/normal BMI group , had a statistically greater proportion of fluoxetine-treated patients who lost at least 5 % of their baseline weight . Overall mean weight change for the fluoxetine-treated patients was about 1 % compared with essentially no change for placebo-treated patients . Only one patients , who was treated with fluoxetine and in the low/normal BMI group , discontinued from the study because of weight loss . Although 5 % weight loss occurred in more fluoxetine-treated than placebo-treated patients , most of the patients who lost weight had higher adiposity at baseline . There was not a statistically significant difference in the proportion of fluoxetine-treated and placebo-treated patients in the low/normal group who had at least 5 % weight loss . Medically relevant weight loss in older patients treated with fluoxetine was uncommon",
"Studies focusing on the prevalence of obesity in Major Depressive Disorder ( MDD ) , or the impact of excess body fat on the treatment of MDD are lacking . The aim of the present work is to systematic ally study obesity in MDD out patients . A total of 369 MDD out patients enrolled in an 8-wk trial of 20 mg fluoxetine had height and weight measured at baseline . We then examined : ( 1 ) the prevalence of being overweight or obese , ( 2 ) the relationship between obesity and a number of demographic and clinical variables , and , ( 3 ) the relationship between relative body weight and obesity with clinical response . We found that more than 50 % of patients were overweight [ body mass index ( BMI ) > or = 2 5 kg/m2 ] , while 20 % were obese ( BMI > or = 30 kg/m2 ) . Obese patients presented with worse somatic well-being scores than non-obese MDD patients , but they did not differ with respect to depression severity , anxiety , somatic complaints , hopelessness or hostility . Greater relative body weight , but not obesity , predicted non-response . In conclusion , greater relative body weight was found to place MDD out patients at risk for fluoxetine resistance",
"Current evidence demonstrates that pharmacologic agents , alone or in combination produce short-term weight-loss and may remain effective for extended periods of time in obese patients . We have evaluated the weight loss of a selective inhibitor of serotonin uptake , fluoxetine , alone as compared with combined therapeutic trial with another serotoninergic drug , dexfenfluramine . Thirty-three patients were r and omly assigned in a double-blind r and omized clinical trial divided to two groups : Group I [ Fluoxetine 40 mg and placebo ( n = 13 ) ] and Group II [ Fluoxetine 40 mg plus dexfenfluramine 15 mg at night ( n = 20 ) ] . Both groups had a significant weight loss at the end of 8 months ( Group I , mean + /- SEM 6.2 + /- 2.8 kg and Group II 13.4 + /- 6.3 kg , p greater weight loss as compared with Group I both in terms of mean weight loss in kg and BMI in kg/m2 . However significance between Group I and II related to BMI mean values and weight mean values were only achieved after , respectively , 4 and 6 months of treatment . At laboratory level there was an elevation of HDL-cholesterol and lowering of serum lipids values ( cholesterol and triglycerides ) in both groups . Side effects were relatively minor and no altered clinical vital signs or abnormal laboratory values were observed . We concluded that the combination of fluoxetine ( daytime ) and dexfenfluramine ( at night ) may be more effective than fluoxetine alone in weight reduction although the small size of this study does not permit broad generalization",
"Discriminant function analysis of data from a double-blind comparative trial of lofepramine ( a noradrenaline-specific reuptake inhibitor ) and fluoxetine ( a serotonin-specific reuptake inhibitor ) , involving 183 patients was used to identify predictors of response . Psychic anxiety significantly predicted a positive response to antidepressant medication , whereas psychomotor retardation , observed sadness , subjective lassitude and somatic complaints were significant predictors of nonresponse . Age , gender , endogenicity , duration of illness and number of previous episodes were not predictive of response . Significant differences were found between predictors of response to fluoxetine and lofepramine ( P psychic anxiety predicted responders whilst observed sadness , psychomotor retardation , lassitude , inability to feel and somatic complaints predicted nonresponders . In contrast , baseline weight loss predicted response to fluoxetine , whereas anxiety , reduced insight and a tendency to blame others significantly predicted nonresponse . Such findings have practical implication s for the management of depressive illness",
"The authors evaluated the efficacy of fluoxetine hydrochloride ( Prozac ; Eli Lilly and Company , Indianapolis , IN ) as an adjunct to behavioral treatment for smoking cessation . Sixteen sites r and omized 989 smokers to 3 dose conditions : 10 weeks of placebo , 30 mg , or 60 mg fluoxetine per day . Smokers received 9 sessions of individualized cognitive-behavioral therapy , and biologically verified 7-day self-reported abstinence follow-ups were conducted at 1 , 3 , and 6 months posttreatment . Analyses assuming missing data counted as smoking observed no treatment difference in outcomes . Pattern-mixture analysis that estimates treatment effects in the presence of missing data observed enhanced quit rates associated with both the 60-mg and 30-mg doses . Results support a modest , short-term effect of fluoxetine on smoking cessation and consideration of alternative models for h and ling missing data",
"Rationale Fluoxetine improves affect in clinical syndromes such as depression and premenstrual dysphoric disorder . Little is known about fluoxetine ’s influence on mood changes after quitting smoking , which often resemble sub- clinical depression . Objectives The present study , a re- analysis of previously published data ( Niaura et al. 2002 ) , examined fluoxetine ’s effect on changes in negative and positive affect following quitting smoking . Methods Adult smokers ( n=175 ) without clinical ly significant depression were r and omized on a double-blind basis to receive fluoxetine hydrochloride ( 30 or 60 mg daily ) or placebo for 10 weeks in combination with cognitive-behavioral therapy ( CBT ) for smoking cessation . We postulated that fluoxetine would beneficially influence post-cessation changes in positive and negative affect . Results Mood change across treatment was analyzed using mixed linear modeling controlling for initial level of nicotine dependence , plasma fluoxetine metabolites , and change in cotinine ( a nicotine metabolite ) at each visit . Relative to placebo , those on 60 mg fluoxetine experienced an elevation in positive affect that increased across time [ t(526)=2.50 , P=0.01 ] , and a reduction in negative affect that returned to baseline across time [ t(524)=2.26 , P=0.02 ] . There were no differences between 30 mg and placebo on changes in positive or negative affect . Conclusions Results indicate that 60 mg of fluoxetine improves both positive and negative mood states after quitting smoking and that diminished positive affect may be an overlooked affective response to smoking cessation",
"The effect of fluoxetine on body weight and spontaneous food choice was studied in twenty-three healthy , non-depressed , obese females on an outpatient basis . After a one week placebo run-in period , subjects were r and omized to receive either fluoxetine ( FXT ) 60 mg daily ( n = 11 ) or placebo ( P ) ( n = 12 ) for 6 weeks in a double blind study design . BMI ( 35.2 + /- 0.8 vs 36.4 + /- 1.3 kg/m2 , mean + /- s.e.m . ) and age ( 38.1 + /- 239 vs 37.3 + /- 2.7 years ) were not different in either group . No specific diet was prescribed . On four separate days per 14 days food records were collected . Data were analysed with the use of food composition tables . Statistical analysis was performed using Student 's t test for independent sample s for data on body weight and calorie intake . Macro-nutrient composition of the diet was analysed using multivariate analysis of variance and post hoc Student 's t test for independent sample s. All subjects lost weight during fluoxetine treatment . Mean ( + /- s.e.m . ) weight loss in the fluoxetine treated group was 3.6 + /- 0.5 kg , compared to a mean weight gain of 0.3 + /- 0.5 kg in the placebo treated group ( P less than 0.001 ) . In all patients food intake was reduced during fluoxetine treatment and this reduction could fully account for the observed weight loss . The mean total caloric intake per day was significantly lower during fluoxetine treatment compared with placebo ( FXT 1123 + /- 118 kcal vs P 1845 + /- 87 kcal , P less than 0.001 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Fluoxetine 's effect ( 30 mg , 60 mg , and placebo ) on postcessation weight gain was studied among participants from a r and omized , double-blind 10-week smoking cessation trial who met strict criteria for abstinence and drug levels . It was hypothesized that ( a ) fluoxetine would dose-dependently suppress postcessation weight gain and ( b ) drug discontinuation would produce dose-dependent weight rebound . During the on-drug phase , placebo participants gained weight linearly ( M = 2.61 kg ) . exceeding both fluoxetine groups ( 30-mg group M = 1.33 kg , 60-mg group M = 1.25 kg ) . Weight suppression was initially greater for 60 mg than 30 mg , but both were followed by weight gain . Six months off drug produced greater dose-dependent weight rebound for 60 mg than 30 mg or placebo . Considering both on- and off-drug phases , weight gain for 60 mg of fluoxetine ( M = 6.5 kg ) was comparable with that for placebo ( M = 4.7 kg ) but greater than that for 30 mg ( M = 3.6 kg ) . Fluoxetine appears to forestall postcessation weight gain , allowing time for the weight-conscious smoker to focus on quitting smoking rather than on preventing weight gain",
"OBJECTIVE The purpose of this study was to determine prospect ively the optimal length of therapy in a long-term , placebo-controlled continuation study of patients who responded to acute fluoxetine treatment for major depression ( defined by DSM-III-R ) . METHOD The study was conducted at five outpatient psychiatric clinics in the United States . Patients who met criteria for remission after 12 or 14 weeks of open-label acute fluoxetine therapy , 20 mg/day ( N=395 of 839 patients ) , were r and omly assigned to one of four arms of a double-blind treatment study ( 50 weeks of placebo , 14 weeks of fluoxetine and then 36 weeks of placebo , 38 weeks of fluoxetine and then 12 weeks of placebo , or 50 weeks of fluoxetine ) . Relapse rate was the primary outcome measure . Both Kaplan-Meier estimates and observed relapse rates were assessed in three fixed 12-week intervals after double-blind transfers from fluoxetine to placebo at the start of the double-blind period and after 14 and 38 weeks of continued fluoxetine treatment . RESULTS Relapse rates ( Kaplan-Meier estimates ) were lower among the patients who continued to take fluoxetine compared with those transferred to placebo in both the first interval , after 24 total weeks of treatment ( fluoxetine , 26.4 % ; placebo , 48.6 % ) , and the second interval , after 38 total weeks of treatment ( fluoxetine , 9.0 % ; placebo , 23.2 % ) . In the third interval , after 62 total weeks of treatment , rates were not significantly different between the groups ( fluoxetine , 10.7 % ; placebo , 16.2 % ) . CONCLUSIONS Patients treated with fluoxetine for 12 weeks whose depressive symptoms remit should continue treatment with fluoxetine for at least an additional 26 weeks to minimize the risk of relapse",
" A total of 27 subjects began active treatment in this double-blind study comparing the efficacy and safety of trazodone and fluoxetine in geriatric depressed patients , but only 13 completed 6 weeks on study medication . Both agents were effective according to weekly and endpoint analyses , and there was no evidence of significant effects on blood pressure , pulse , or weight . Separate analysis of patients who had received an adequate trial of medication indicated a trend toward relatively more fluoxetine-treated patients meeting clinical criteria for resolved depression . ( J Geriatr Psychiatry Neurol 1989;2:208 - 214 .",
"Our study aims at assessing the efficacy and safety of fluoxetine as compared with placebo in the treatment of obesity using a double-blind crossover design . We studied 42 obese women ( body mass index 35.9 + /- 5.3 kg/m2 ) . The obese patients were r and omized to start treatment with fluoxetine ( group A ) or placebo ( group B ) for 3 months ( period 1 ) . After a 1-month washout period , treatment was crossed for the following 3 months ( period 2 ) . There was no significant difference in weight loss when the patients were treated with fluoxetine ( group A period 1 and group B period 2 ) as compared with patients treated with placebo ( group B period 1 and group A period 2 ) . There were no significant differences in monthly weight reduction during both treatments . In conclusion , we demonstrated that serotoninergic drugs such as fluoxetine need further investigation before being used indiscriminately in obese subjects"
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To investigate if there is evidence for a ‘ legacy effect ’ for blood pressure ( BP ) lowering treatment , that is , worse health outcomes from not initiating drug treatment at a systolic BP threshold of 140 mmHg in middle-age adults . We systematic ally review ed studies comparing the effects of delayed BP treatment ( placebo/untreated during the trial or no previous treatment at trial entry ) vs. early treatment ( actively treated during the trial or previous BP treatment at trial entry ) on mortality in the short term ( 5-year in-trial period ) and long term ( ≥10 years in total period ) . The data were pooled using Peto ORs . A subgroup analysis by 10-year Framingham risk score was performed . Three studies ( ALLHAT , Oslo and PREVEND-IT ) involving 4746 participants were included . The results were heavily influenced by the ALLHAT trial . We found no significant difference in all-cause mortality between ‘ delayed BP ’ and ‘ early treatment ’ in the short-term OR 0.95 ( 95 % CI 0.68–1.32 ) or long-term OR 0.90 ( 95 % CI 0.78–1.04 ) , with similar results for mortality from cardiovascular disease ( CVD ) . The effects of delayed BP lowering treatment on long-term all-cause and CVD mortality did not vary with baseline risk of CVD . The review showed no clinical ly adverse ‘ legacy effect ’ on mortality or major CVD event from not treating middle-aged adults at a systolic BP threshold of 140 mmHg or over . The results were consistent for all CVD risk subgroups . Although these studies are non-r and omised post-hoc analyses , they may allay concerns that early treatment of elevated systolic BP is necessary to prevent CVD events in primary prevention population
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"BACKGROUND The PREVEND IT investigated whether treatment targeted at lowering urinary albumin excretion ( UAE ) would reduce adverse cardiovascular events . We obtained extended follow-up data to approximately 10 years to investigate the long-term effects of fosinopril 20 mg and pravastatin 40 mg on cardiovascular outcomes in subjects with UAE > 15 mg per 24 hours . METHODS The original PREVEND IT consisted of 864 participants and 839 survivors after 4 years . For every survivor , the primary end point determined by the combined incidence of cardiovascular mortality and hospitalization for cardiovascular morbidity was registered in several national data bases and electronic hospital systems . RESULTS Mean total follow-up of the extended PREVEND IT was 9.5 years ( range 9.4 - 10.7 years ) . Four years of treatment with fosinopril was not associated with a reduction in the primary end point compared with placebo ( hazard ratio 0.87 , 95 % CI 0.61 - 1.24 [ P = .42 ] ) during long-term follow-up . After 9.5 years , subjects with a baseline UAE in the upper quintile ( > 50 mg/24 hours ) had a total event rate of 29.5 % and were at a higher risk for developing cardiovascular disease compared with less UAE ( hazard ratio 2.03 , 95 % CI 1.38 - 2.97 [ P ≤ .01 ] ) . In addition , 4 years of fosinopril treatment result ed in a risk reduction of 45 % ( 95 % CI 6%-75 % [ P = .04 ] ) in this group compared with placebo . Subjects originally assigned to pravastatin had no overall risk reduction in the primary end point ( P = .99 ) . CONCLUSIONS Elevated UAE is associated with increased cardiovascular mortality and morbidity after 9.5 years of follow-up , with a doubling of the risk if the UAE is > 50 mg per 24 hours . In this group , the benefits of 4-year treatment with fosinopril were sustained during posttrial follow-up for cardiovascular mortality and morbidity . We propose that UAE be used to estimate risk in the general population and that large clinical trials be design ed to confirm the hypothesis that angiotensin-converting enzyme-inhibitor treatment may be beneficial in patients with mildly elevated UAE despite the absence of other comorbidities",
"Background Many national and international guidelines recommend that the initiation of blood pressure (BP)-lowering drug treatment for the primary prevention of cardiovascular disease ( CVD ) should no longer be based on BP level alone , but on absolute cardiovascular risk . While BP-lowering drug treatment is beneficial in high-risk individuals at any level of elevated BP , clinicians are concerned about legacy effects on patients with low-to-moderate risk and mildly elevated BP who remain “ untreated ” . Objective We aim to investigate the legacy effect of delayed BP-lowering pharmacotherapy in middle-aged individuals ( 45 - 65 years ) with mildly elevated BP ( systolic BP 140 - 159 mmHg and /or diastolic BP 90 - 99 mmHg ) stratified by absolute risk for primary prevention of CVD , but particularly in the low-risk ( Methods R and omized trials of BP-lowering therapy versus placebo or pretreated subjects in active comparator studies with posttrial follow-up will be identified using a 2-step process . First , r and omized trials of BP-lowering therapy will be identified by ( 1 ) retrieving the references of trials included in published systematic review s of BP-lowering therapy , ( 2 ) retrieving studies published by the Blood Pressure Lowering Treatment Trialists ’ Collaboration ( BPLTTC ) , and ( 3 ) checking studies referenced in the 1993 World Health Organization/International Society of Hypertension meeting memor and um on BP management . Posttrial follow-up studies will then be identified by forward citation search ing the r and omized trials identified in step 1 through Web of Science . The search will include r and omized controlled trials with at least 1-year in-trial period and a posttrial follow-up phase . Age is the major determinant of absolute cardiovascular risk , so the participants in our review will be restricted to middle-aged adults who are more likely to have a lower cardiovascular risk profile . The primary outcome will be all-cause mortality . Secondary outcomes will include cardiovascular mortality , fatal stroke , fatal myocardial infa rct ion , and death due to heart failure . Results The search es for existing systematic review s and BPLTTC studies were piloted and modified . The study is expected to be completed before June 2018 . Conclusions The findings of this study will contribute to the body of knowledge concerning the beneficial , neutral , or harmful effects of delayed BP-lowering drug treatment on the primary prevention of CVD in patients with mildly elevated BP and low-to-moderate CVD risk . Trial Registration PROSPERO International Prospect i ve Register of Systematic Review s : CRD42017058414 ; https://www.crd.york.ac.uk/ PROSPERO /display_record.asp?ID = CRD42017058414 ( Archived by WebCite ® at http://www.webcitation.org/6t6sa8O2Q",
"Objectives In many current guidelines , blood pressure (BP)-lowering drug treatment for primary prevention of cardiovascular disease ( CVD ) is based on absolute risk . However , in clinical practice , therapeutic decisions are often based on BP levels alone . We sought to investigate which approach was superior by conducting a post hoc analysis of the Australian National Blood Pressure ( ANBP ) cohort , a seminal study establishing the efficacy of BP lowering in ‘ mild hypertensive ’ persons . Design A post hoc subgroup analysis of the ANBP trial results by baseline absolute risk tertile . Setting and participants 3244 participants aged 35–69 years in a community-based r and omised placebo controlled trial of blood pressure-lowering medication . Interventions Chlorothiazide500 mg versus placebo . Primary outcome measures All-cause mortality and non-fatal events ( non-fatal CVD , congestive cardiac failure , renal failure , hypertensive retinopathy or encephalopathy ) . Results Treatment effects were assessed by HR , absolute risk reduction and number needed to treat . Participants had an average 5-year CVD risk in the intermediate range ( 10.5±6.5 ) with moderately elevated BP ( mean 159/103 mmHg ) and were middle aged ( 52±8 years ) . In a subgroup analysis , the relative effects ( HR ) and absolute effects ( absolute risk reduction and number needed to treat ) did not statistically differ across the three risk groups except for the absolute benefit in all-cause mortality ( p for heterogeneity=0.04 ) . With respect to absolute benefit , drug treatment significantly reduced the number of events in the high-risk group regarding any event with a number needed to treat of 18 ( 10 to 64 ) , death from any cause with 45 ( 25 to 196 ) and major CVD events with 23 ( 12 to 193 ) . Conclusion Our analysis confirms that the benefit of treatment was substantial only in the high-risk tertile , reaffirming the rationale of treating elevated blood pressure in the setting of all risk factors rather than in isolation",
"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 ",
"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 Previous studies have suggested that blockade of the renin-angiotensin system may prevent diabetes in people with cardiovascular disease or hypertension . METHODS In a double-blind , r and omized clinical trial with a 2-by-2 factorial design , we r and omly assigned 5269 participants without cardiovascular disease but with impaired fasting glucose levels ( after an 8-hour fast ) or impaired glucose tolerance to receive ramipril ( up to 15 mg per day ) or placebo ( and rosiglitazone or placebo ) and followed them for a median of 3 years . We studied the effects of ramipril on the development of diabetes or death , whichever came first ( the primary outcome ) , and on secondary outcomes , including regression to normoglycemia . RESULTS The incidence of the primary outcome did not differ significantly between the ramipril group ( 18.1 % ) and the placebo group ( 19.5 % ; hazard ratio for the ramipril group , 0.91 ; 95 % confidence interval [ CI ] , 0.81 to 1.03 ; P=0.15 ) . Participants receiving ramipril were more likely to have regression to normoglycemia than those receiving placebo ( hazard ratio , 1.16 ; 95 % CI , 1.07 to 1.27 ; P=0.001 ) . At the end of the study , the median fasting plasma glucose level was not significantly lower in the ramipril group ( 102.7 mg per deciliter [ 5.70 mmol per liter ] ) than in the placebo group ( 103.4 mg per deciliter [ 5.74 mmol per liter ] , P=0.07 ) , though plasma glucose levels 2 hours after an oral glucose load were significantly lower in the ramipril group ( 135.1 mg per deciliter [ 7.50 mmol per liter ] vs. 140.5 mg per deciliter [ 7.80 mmol per liter ] , P=0.01 ) . CONCLUSIONS Among persons with impaired fasting glucose levels or impaired glucose tolerance , the use of ramipril for 3 years does not significantly reduce the incidence of diabetes or death but does significantly increase regression to normoglycemia . ( Clinical Trials.gov number , NCT00095654 [ Clinical Trials.gov ] . )",
"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 ] . )",
"Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies",
"Background To assess the impact of immediate versus delayed antihypertensive treatment on the outcome of older patients with isolated systolic hypertension , we extended the double-blind placebo-controlled Systolic Hypertension in Europe ( Syst-Eur ) trial by an open-label follow-up study lasting 4 years . Methods The Syst-Eur trial included 4695 r and omized patients with minimum age of 60 years and an untreated blood pressure of 160–219 mmHg systolic and below 95 mmHg diastolic . The double-blind trial ended after a median follow-up of 2.0 years ( range 1–97 months ) . Of 4409 patients still alive , 3517 received open-label treatment consisting of nitrendipine ( 10–40 mg daily ) with the possible addition of enalapril ( 5–20 mg daily ) , hydrochlorothiazide ( 12.5–25 mg daily ) , or both add-on drugs . Non- participants ( n = 892 ) were also followed up . Results Median follow-up increased to 6.1 years . Systolic pressure decreased to below 150 mmHg ( target level ) in 2628 participants ( 75.0 % ) . During the 4-year open-label follow-up , stroke and cardiovascular complications occurred at similar frequencies in patients formerly r and omized to placebo and those continuing active treatment . These rates were similar to those previously observed in the active-treatment group during the double-blind trial . Considering the total follow-up of 4695 r and omized patients , immediate compared with delayed antihypertensive treatment reduced the occurrence of stroke and cardiovascular complications by 28 % ( P = 0.01 ) and 15 % ( P = 0.03 ) , respectively , with a similar tendency for total mortality ( 13 % , P = 0.09 ) . In 492 diabetic patients , the corresponding estimates of long-term benefit ( P blood pressure control in most older patients with isolated systolic hypertension . Immediate compared with delayed treatment prevented 17 strokes or 25 major cardiovascular events per 1000 patients followed up for 6 years . These findings underscore the necessity of early treatment of isolated systolic hypertension",
"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 .",
"The Oslo Hypertension Study began in 1972 ; patients were followed for an average of 66 months ( range : 60 to 78 ) . A total of 785 healthy men , aged 40 to 49 , with mild hypertension was r and omly assigned to either a drug-treated group or to an untreated control group . Hydrochlorothiazide was used alone in 36 percent of patients , in combination with propranolol in 26 percent , and with methyldopa in 20 percent . Other drugs , including combinations with hydrochlorothiazide , were used in 18 percent . A total of 95 percent of patients in the drug-treated group received hydrochlorothiazide . Complications of hypertension such as stroke and aneurysm occurred only in the control group . Coronary events were more numerous in the drug-treated group ; thus , the total incidence of cardiovascular complications did not significantly differ between the treated and untreated groups . After five and 10 years , total mortality was the same in both groups . However , the coronary heart disease mortality rate at 10 years was significantly greater in the drug-treated group than in the untreated control group ( 14 versus three , p less than 0.01 ) . This article presents possible reasons for the failure of antihypertensive drug therapy to prevent coronary heart disease . The adverse effect of diuretics and beta-adrenergic blockers , both on lipid and carbohydrate metabolism , is contrasted with the effect of the alpha-adrenergic blocker prazosin , which has been shown to have no adverse effect on the blood lipid profile . In a short-term trial that was part of the Oslo Study , prazosin was found to reduce total serum cholesterol by 9 percent , low-density lipoprotein and very-low-density lipoprotein cholesterol by 10 percent , and total triglycerides by 16 percent . All these changes are statistically significant",
"BACKGROUND In the Oslo cardiovascular study of 1972 - 3 a 5-year r and omized trial in mild to moderate hypertension was performed . Several changes in treatment practice s have been recommended since that time . We followed the mortality patterns up to 40 years . METHODS Invited to the Oslo study screening were 25,915 middle-aged men and 16,203 ( 63 % ) participated . Reexaminations were done to select suitable participants into the trial . Men had blood pressure 150 - 179/95 - 109 mm Hg and the active group ( n=406 ) was treated with thiazides , alpha-methyldopa and propranolol versus untreated controls ( n=379 ) . Cox regression analysis was used for statistical analyses . RESULTS There was no trend towards reduction in total mortality by treatment . A nominally significant increase in risk of death at first myocardial infa rct ion was observed in the trial treatment group across the follow-up period , HR=1.51 ( 1.01 - 2.25 ) ; ( P=0.042 ) . The excess risk developed rapidly during the first 15 years , but the gap between the groups diminished to a large extent during the next 15 years , but the curves stayed at a certain distance for the last 10 years . Cerebrovascular death tended to be non-significantly reduced , HR=0.85 ( 0.52 - 1.41 ) . CONCLUSIONS Drug treatment of mild hypertensive men initiated in the 1970s did not reduce mortality at first MI or total mortality . However , during the period ( late 1980s and whole 1990s ) , when large changes in hypertension treatment practice s occurred into regimes with more use of combination therapies including metabolically neutral drugs at lower doses , beneficial effects on MI mortality could be observed",
"Objectives : Current blood pressure ( BP ) management guidelines recommend that treatment thresholds for BP be based on absolute cardiovascular disease ( CVD ) risk rather than on elevated BP levels alone . Clinicians are concerned that delayed pharmacotherapy in individuals with high BP , but low CVD risk , may increase long-term CVD events . To investigate this , we examined differences in CVD events within the Second Australian National BP study ( ANBP2 ) for those previously on pharmacotherapy and those who were not , as well as fatal events in the 6-year post-trial period . Methods : Population consisted of ANBP2 participants without a prior CVD event . Adjusted Cox-regression hazard models were used to assess the effects of prior BP pharmacotherapy use on cardiovascular endpoints within ANBP2 . An extended 6-year follow-up analysis for cardiovascular and all-cause mortality was also conducted . Results : We found a higher in-trial CVD and all-cause mortality rate and incidence of new-onset diabetes for those on previous treatment versus those who were treatment-naive . We investigated whether this was an effect of the in-trial protocol , but this did not explain the observed differences . No difference in CVD or all-cause mortality at 10 years was observed between ‘ treatment-naive ’ and ‘ previous treatment ’ groups . Conclusion : We found no long-term adverse mortality associated with treatment naivety of elevated BP in an elderly hypertensive cohort , but this finding is likely to be confounded as seen by the lower in-trial mortality in the ‘ treatment-naive ’ group . Legacy effects need to be explored in r and omized trials of middle-aged population s where the clinical concern lies",
"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",
"CONTEXT In the Systolic Hypertension in the Elderly Program ( SHEP ) trial , conducted between 1985 and 1990 , antihypertensive therapy with chlorthalidone-based stepped-care therapy result ed in a lower rate of cardiovascular events than placebo but effects on mortality were not significant . OBJECTIVE To study the gain in life expectancy of participants r and omized to active therapy at the 22-year follow-up . DESIGN , SETTING , AND PARTICIPANTS A National Death Index ascertainment of death in the long-term follow-up of a r and omized , placebo-controlled , clinical trial ( SHEP ) of patients aged 60 years or older with isolated systolic hypertension . Recruitment was between March 1 , 1985 , and January 15 , 1988 . After the end of a 4.5-year r and omized phase of the SHEP trial , all participants were advised to receive active therapy . The time interval between the beginning of recruitment and the ascertainment of death by National Death Index ( December 31 , 2006 ) was approximately 22 years ( 21 years 10 months ) . MAIN OUTCOME MEASURES Cardiovascular death and all-cause mortality . RESULTS At the 22-year follow-up , life expectancy gain , expressed as the area between active ( n = 2365 ) and placebo ( n = 2371 ) survival curves , was 105 days ( 95 % CI , -39 to 242 ; P = .07 ) for all-cause mortality and 158 days ( 95 % CI , 36 - 287 ; P = .009 ) for cardiovascular death . Each month of active treatment was therefore associated with approximately 1 day extension in life expectancy . The active treatment group had higher survival free from cardiovascular death vs the placebo group ( hazard ratio [ HR ] , 0.89 ; 95 % CI , 0.80 - 0.99 ; P = .03 ) but similar survival for all-cause mortality ( HR , 0.97 ; 95 % CI , 0.90 - 1.04 ; P = .42 ) . There were 1416 deaths ( 59.9 % ) in the active treatment group and 1435 deaths ( 60.5 % ) in the placebo group ( log-rank P = .38 , Wilcoxon P = .24 ) . Cardiovascular death was lower in the active treatment group ( 669 deaths [ 28.3 % ] ) vs the placebo group ( 735 deaths [ 31.0 % ] ; log-rank P = .03 , Wilcoxon P = .02 ) . Time to 70th percentile survival was 0.56 years ( 95 % CI , -0.14 to 1.23 ) longer in the active treatment group vs the placebo group ( 11.53 vs 10.98 years ; P = .03 ) for all-cause mortality and 1.41 years ( 95 % CI , 0.34 - 2.61 ; 17.81 vs 16.39 years ; P = .01 ) for survival free from cardiovascular death . CONCLUSION In the SHEP trial , treatment of isolated systolic hypertension with chlorthalidone stepped-care therapy for 4.5 years was associated with longer life expectancy at 22 years of follow-up",
"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"
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OBJECTIVES The purpose of this study was to evaluate the antihypertensive efficacy of hydrochlorothiazide ( HCTZ ) by ambulatory blood pressure ( BP ) monitoring . BACKGROUND HCTZ is the most commonly prescribed antihypertensive drug worldwide . More than 97 % of all HCTZ prescriptions are for 12.5 to 25 mg per day . The antihypertensive efficacy of HCTZ by ambulatory BP monitoring is less well defined . METHODS A systematic review was made using Medline , Cochrane , and Embase for all the r and omized trials that assessed 24-h BP with HCTZ in comparison with other antihypertensive drugs . RESULTS Fourteen studies of HCTZ dose 12.5 to 25 mg with 1,234 patients and 5 studies of HCTZ dose 50 mg with 229 patients fulfilled the inclusion criteria . The decrease in 24-h BP with HCTZ dose 12.5 to 25 mg was systolic 6.5 mm Hg ( 95 % confidence interval : 5.3 to 7.7 mm Hg ) and diastolic 4.5 mm Hg ( 95 % confidence interval : 3.1 to 6.0 mm Hg ) and was inferior compared with the 24-h BP reduction of angiotensin-converting enzyme inhibitors ( mean BP reduction 12.9/7.7 mm Hg ; p systolic ( p = 0.30 ) and diastolic ( p = 0.15 ) 24-h BP reduction between HCTZ 12.5 mg ( 5.7/3.3 mm Hg ) and HCTZ 25 mg ( 7.6/5.4 mm Hg ) . However , with HCTZ 50 mg , the reduction in 24-h BP was significantly higher ( 12.0/5.4 mm Hg ) and was comparable to that of other agents . CONCLUSIONS The antihypertensive efficacy of HCTZ in its daily dose of 12.5 to 25 mg as measured in head-to-head studies by ambulatory BP measurement is consistently inferior to that of all other drug classes . Because outcome data at this dose are lacking , HCTZ is an inappropriate first-line drug for the treatment of hypertension
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"Background The efficacy of angiotensin-converting enzyme ( ACE ) inhibitors in decreasing blood pressure in African patients is controversial . Objective We examined the ambulatory blood pressure ( ABP ) response to a diuretic and an ACE inhibitor in hypertensive patients of East African descent and evaluated the individual characteristics that determined treatment efficacy . Design A single-blind r and omized AB/BA crossover design . Setting Hypertensive families of East African descent from the general population in the Seychelles . Participants Fifty-two ( 29 men and 23 women ) out of 62 eligible hypertensive patients were included . Main outcome measures ABP response to 20 mg lisinopril ( LIS ) daily and 25 mg hydrochlorothiazide ( HCT ) daily given for a 4-week period . Results The daytime systolic/diastolic ABP response to HCT was 4.9 [ 95 % confidence interval ( CI ) 1.2–8.6]/3.6 ( 1.0–6.2 ) mmHg for men and 12.9 (9.2–16.6)/6.3 ( 3.7–8.8 ) mmHg for women . With LIS the response was 18.8 (15.0–22.5)/14.6 ( 12.0–17.1 ) mmHg for men and 12.4 (8.7–16.2)/7.7 ( 5.1–10.2 ) mmHg for women . The night-time systolic/diastolic response to HCT was 5.0 (0.6–9.4)/2.7 [ (−0.4)–5.7 ] mmHg for men and 11.5 (7.1–16.0)/5.7 ( 2.6–8.8 ) mmHg for women , and to LIS was 18.7 (14.2–22.1)/15.4 ( 12.4–18.5 ) mmHg for men and 3.5 [(−1.0)–7.9]/2.3 [ (−0.8)–5.4 ] mmHg for women . Linear regression analyses showed that gender is an independent predictor of the ABP responses to HCT and to LIS . Conclusions Hypertensive patients of African descent responded better to LIS than to HCT . Men responded better to LIS than to HCT and women responded similarly to both drugs",
"Low-dose thiazide-type diuretics are recommended as initial therapy for most hypertensive patients . Chlorthalidone has significantly reduced stroke and cardiovascular end points in several l and mark trials ; however , hydrochlorothiazide remains favored in practice . Most clinicians assume that the drugs are interchangeable , but their antihypertensive effects at lower doses have not been directly compared . We conducted a r and omized , single-blinded , 8-week active treatment , crossover study comparing chlorthalidone 12.5 mg/day ( force-titrated to 25 mg/day ) and hydrochlorothiazide 25 mg/day ( force-titrated to 50 mg/day ) in untreated hypertensive patients . The main outcome , 24-hour ambulatory blood pressure ( BP ) monitoring , was assessed at baseline and week 8 , along with st and ard office BP readings every 2 weeks . Thirty patients completed the first active treatment period , whereas 24 patients completed both . An order – drug – time interaction was observed with chlorthalidone ; therefore , data from only the first active treatment period was considered . Week 8 ambulatory BPs indicated a greater reduction from baseline in systolic BP with chlorthalidone 25 mg/day compared with hydrochlorothiazide 50 mg/day ( 24-hour mean = −12.4±1.8 mm Hg versus −7.4±1.7 mm Hg ; P=0.054 ; nighttime mean = −13.5±1.9 mm Hg versus −6.4±1.8 mm Hg ; P=0.009 ) . Office systolic BP reduction was lower at week 2 for chlorthalidone 12.5 mg/day versus hydrochlorothiazide 25 mg/day ( −15.7±2.2 mm Hg versus −4.5±2.1 mm Hg ; P=0.001 ) ; however , by week 8 , reductions were statistically similar ( −17.1±3.7 versus −10.8±3.5 ; P=0.84 ) . Within recommended doses , chlorthalidone is more effective in lowering systolic BPs than hydrochlorothiazide , as evidence d by 24-hour ambulatory BPs . These differences were not apparent with office BP measurements ",
"Office , home , and ambulatory blood pressure ( BP ) demonstrate variable associations with outcomes . The authors sought to compare office BP ( OBP ) , home BP ( HBP ) , and ambulatory BP ( ABP ) for measuring responses to hydrochlorothiazide ( HCTZ ) , atenolol , and their combination . After completing washout , eligible patients were r and omized to atenolol 50 mg or HCTZ 12.5 mg daily . Doses were doubled after 3 weeks and the alternate drug was added after 6 weeks if BP was > 120/70 mm Hg ( chosen to allow maximum opportunity to assess genetic associations with dual BP therapy in the parent study ) . OBP ( in triplicate ) , HBP ( twice daily for 5 days ) , and 24-hour ABP were measured at baseline , after monotherapy , and after combination therapy . BP responses were compared between OBP , HBP , and ABP for each monotherapy and combination therapy . In 418 patients , OBP overestimated BP response compared with HBP , with an average 4.6 mm Hg greater reduction in systolic BP ( P diastolic BP ( P atenolol and HCTZ monotherapy . ABP response was more highly correlated with HBP response ( r=0.58 ) than with OBP response ( r=0.47 ; P=.04 ) . In the context of a r and omized clinical trial , the authors have identified significant differences in HBP , OBP , and ABP methods of measuring BP response to atenolol and HCTZ monotherapy",
"BACKGROUND Treatment of hypertension with diuretics , beta-blockers , or both leads to improved outcomes . It has been postulated that agents that inhibit the renin-angiotensin system confer benefit beyond the reduction of blood pressure alone . We compared the outcomes in older subjects with hypertension who were treated with angiotensin-converting-enzyme ( ACE ) inhibitors with the outcomes in those treated with diuretic agents . METHODS We conducted a prospect i ve , r and omized , open-label study with blinded assessment of end points in 6083 subjects with hypertension who were 65 to 84 years of age and received health care at 1594 family practice s. Subjects were followed for a median of 4.1 years , and the total numbers of cardiovascular events in the two treatment groups were compared with the use of multivariate proportional-hazards models . RESULTS At base line , the treatment groups were well matched in terms of age , sex , and blood pressure . By the end of the study , blood pressure had decreased to a similar extent in both groups ( a decrease of 26/12 mm Hg ) . There were 695 cardiovascular events or deaths from any cause in the ACE-inhibitor group ( 56.1 per 1000 patient-years ) and 736 cardiovascular events or deaths from any cause in the diuretic group ( 59.8 per 1000 patient-years ; the hazard ratio for a cardiovascular event or death with ACE-inhibitor treatment was 0.89 [ 95 percent confidence interval , 0.79 to 1.00 ] ; P=0.05 ) . Among male subjects , the hazard ratio was 0.83 ( 95 percent confidence interval , 0.71 to 0.97 ; P=0.02 ) ; among female subjects , the hazard ratio was 1.00 ( 95 percent confidence interval , 0.83 to 1.21 ; P=0.98 ) ; the P value for the interaction between sex and treatment-group assignment was 0.15 . The rates of nonfatal cardiovascular events and myocardial infa rct ions decreased with ACE-inhibitor treatment , whereas a similar number of strokes occurred in each group ( although there were more fatal strokes in the ACE-inhibitor group ) . CONCLUSIONS Initiation of antihypertensive treatment involving ACE inhibitors in older subjects , particularly men , appears to lead to better outcomes than treatment with diuretic agents , despite similar reductions of blood pressure",
"This placebo-controlled multifactorial design trial assessed the antihypertensive efficacy of nebivolol , a novel cardioselective beta 1-blocker with vasodilating properties , and hydrochlorothiazide monotherapy and in combination . After a 4-week placebo period , 240 white patients with a mean daytime ambulatory blood pressure of > or = 90 mm Hg were r and omized to receive either placebo , nebivolol ( 1 , 5 , or 10 mg ) , hydrochlorothiazide ( 12.5 or 25 mg ) , or one of the six possible combinations of nebivolol and hydrochlorothiazide for 12 weeks . A dose-related reduction in clinic and ambulatory blood pressure was demonstrated for each drug as monotherapy and for the two drugs in combination . Nebivolol , 5- and 10-mg doses , showed a larger effect than hydrochlorothiazide doses on clinic blood pressure and over the 24-h interval . Moreover , the combination doses had substantial antihypertensive effects that were sustained over the entire 24-h profile with a greater effect observed with the higher dose combinations . The reduction in ambulatory blood pressure was further substantiated by the reduction of blood pressure loads ( % of BP > 140/90 mm Hg awake and > 120/80 mm Hg asleep ) to as low as 11.5 % with 10 mg of nebivolol combined with 25 mg of hydrochlorothiazide . Nebivolol and hydrochlorothiazide were well tolerated . We provided evidence that nebivolol , given as monotherapy or in combination with low dose of hydrochlorothiazide , is effective in reducing clinic and 24-h ambulatory blood pressure in patients with ambulatory hypertension . The results provided further evidence for the use of ambulatory blood pressure monitoring and factorial design s when investigating new antihypertensive agents",
"Diuretic-based therapy is less effective in reducing the cardiac complications of hypertension than the risk of stroke and may be less effective in reducing left ventricular ( LV ) mass than is therapy with angiotensin converting enzyme ( ACE ) inhibition . In view of the strong association of LV hypertrophy with cardiovascular risk , this study was design ed to compare the impact of therapy with a diuretic and ACE inhibition on cardiac and vascular structure . Fifty essential hypertensives ( 74 % male , 88 % nonwhite ) participated in a double-blind study for 6 months and were r and omized to either ramipril or hydrochlorothiazide ( HCTZ ) . Echocardiography , carotid ultrasonography , and ambulatory blood pressure ( BP ) monitoring were performed at baseline and 3 and 6 months after initiation of therapy . The 22 ramipril patients were comparable to the 28 HCTZ patients at baseline in age , race , and 24-h BP . Although HCTZ result ed in a greater reduction in 24-h BP , only treatment with ramipril result ed in a decrease in LV mass ( 193 to 179 g , P wall thicknesses but not in chamber diameter . In multivariate analysis , both change in BP and treatment group were independent predictors of change in LV mass . Importantly , although neither drug reduced carotid artery cross-sectional area , relative wall thickness increased due to a tendency for vessel diameter to decrease and wall thickness to increase , particularly in the diuretic group . Ramipril caused a sustained fall in plasma angiotensin II , whereas HCTZ increased angiotensin II levels . Although diuretic therapy was more effective in lowering ambulatory BP in this predominantly nonwhite population , only therapy with ACE inhibition was associated with regression of LV mass . Vascular geometry was altered consistent with the reduction in distending pressure result ing in vascular remodelling",
"Antihypertensive efficacy , effects on left ventricular mass index ( LVMI ) and tolerability of telmisartan , an angiotensin II receptor blocker , were compared with those of hydrochlorothiazide ( HCTZ ) . Adult patients with mild-to-moderate hypertension and an optimal acoustic window by two-dimensional echocardiography were r and omised at baseline to 12 months ' double-blind , once-daily treatment with telmisartan 80 mg or HCTZ 25 mg . Two-dimensional echocardiography and freeh and precordial three-dimensional echocardiography and 24-h ambulatory blood pressure monitoring were performed at baseline and after treatment . Of the 41 telmisartan group patients and 28 HCTZ group patients , 40 and 25 , respectively , completed the study . Following treatment , 24-h mean SBP ( telmisartan 157 ± 11 vs 133 ± 7 mmHg , P HCTZ 154 ± 10 vs 144 ± 11 mmHg , P ) and DBP ( telmisartan 96 ± 6 vs 83 ± 5 mmHg , P ; HCTZ 95 ± 7 vs 87 ± 8 mmHg , P significantly reduced . Telmisartan produced significantly greater 24-h mean SBP and DBP reductions than HCTZ ( P was significantly reduced by telmisartan ( 141 ± 16 vs 125 ± 19 g/m2 , P by HCTZ ( 139 ± 20 vs 135 ± 22 g/m2 ) . Incidences of adverse events in both the treatment groups were low ; two cases of hypokalaemia occurred with HCTZ . In conclusion , telmisartan 80 mg was well tolerated and significantly reduced SBP , DBP and LVMI after 12 months ' treatment compared with HCTZ ",
"Because obesity-associated hypertension has unique hemodynamic and hormonal profiles , certain classes of antihypertensive agents may be more effective than others as monotherapy . Thus , we compared the efficacy and safety of the angiotensin-converting enzyme inhibitor lisinopril and the diuretic hydrochlorothiazide in a 12-week , multicenter , double-blind trial in 232 obese patients with hypertension . Patients with an office diastolic pressure between 90 and 109 mm Hg were r and omized to treatment with daily doses of lisinopril ( 10 , 20 , or 40 mg ) , hydrochlorothiazide ( 12.5 , 25 , or 50 mg ) , or placebo . Mean body mass indexes were similar for all patients . At week 12 , lisinopril and hydrochlorothiazide effectively lowered office diastolic ( -8.3 and -7.7 versus -3.3 mm Hg , respectively ; P systolic ( -9.2 and -10.0 versus -4.6 mm Hg , respectively ; P pressures compared with placebo . Ambulatory blood pressure monitoring confirmed that lisinopril and hydrochlorothiazide effectively lowered 24-hour blood pressure compared with placebo ( P lisinopril had an office diastolic pressure Responses to therapies differed with both race and age . Neither treatment significantly affected insulin or lipid profiles ; however , plasma glucose increased significantly after 12 weeks of hydrochlorothiazide therapy compared with lisinopril ( + 0.31 versus -0.21 mmol/L ; P Hydrochlorothiazide also decreased serum potassium levels by 0.4 mmol/L from baseline . In conclusion , lisinopril was as effective as hydrochlorothiazide in treating obese patients with hypertension . Treatment with angiotensin-converting enzyme inhibitors may show greater efficacy as monotherapy at lower doses compared with thiazide diuretics , may have a more rapid rate of response , and may offer advantages in patients at high risk of metabolic disorders",
"To compare the effects of exercise training and hydrochlorothiazide on left ventricular ( LV ) geometry and mass , blood pressure ( BP ) , and hyperinsulinemia in older hypertensive adults , we studied 28 patients r and omized either to a group ( age 66.4 + /- 1.3 yr ; n = 16 ) that exercised or to a group ( age 65.3 + /- 1.2 yr ; n = 12 ) that received hydrochlorothiazide for 6 mo . Endurance exercise training induced a 15 % increase in peak aerobic power . The reduction in systolic BP was twofold greater with thiazide than with exercise ( 26.6 + /- 12.2 vs. 11.5 + /- 10.9 mmHg ) . Exercise and thiazide reduced LV wall thickness , LV mass index ( 14 % in each group ) , and the LV wall thickness-to-radius ratio ( h/r ) similarly ( exercise : before 0.48 + /- 0.2 , after 0.42 + /- 0.01 ; thiazide : before 0.47 + /- 0.04 , after 0.40 + /- 0.04 ; P = 0.017 ) . The reductions in systolic BP and h/r were correlated in the exercise group ( r = 0.70 , P = 0.005 ) but not in the thiazide group . Exercise training reduced glucose-stimulated hyperinsulinemia ( before : 13.65 + /- 2.6 vs. 9.84 + /- 1.5 mU.ml(-1).min ; P = 0.04 ) and insulin resistance . Thiazide did not affect plasma insulin levels . The results suggest that although exercise is less effective in reducing systolic BP than thiazide , it can induce regression of LV hypertrophy similar in magnitude to thiazide . Unlike hydrochlorothiazide , exercise training can improve insulin resistance and aerobic capacity in older hypertensive people",
"OBJECTIVE To evaluate whether the additional antihypertensive efficacy of the nifedipine-thiazide combination depends on the sequence of drug administration and whether the natriuretic effect of thiazide persists when co-administered with nifedipine . METHODS Double blind , r and omised , crossover , placebo-controlled study , in 12 salt-sensitive hypertensive black patients ( SSH ) . Evaluation of the antihypertensive ( 24 h ambulatory monitoring ) and natriuretic effects of placebo ( PL ) , of nifedipine-GITS ( NIF , 30 mg/d ) and of hydrochlorothiazide ( HCTZ , 25 mg/d ) given alone and in combination within two separate therapeutic sequences : PL-->NIF-->NIF + HCTZ and PL-->HCTZ-->HCTZ + NIF ( 1 month for each therapeutic regimen ) . RESULTS NIF induced greater ( p 24 h mean arterial pressure ( MAP ) ( -15.9 + /- 1.9 mm Hg , v PL ) than HCTZ ( -9.0 + /- 1.3 mm Hg ) . The association of NIF to HCTZ induced a greater ( p MAP-24 h ( 9.7 + /- 2.2 mm Hg ) than that produced by the association of HCTZ to NIF ( 4.1 + /- 1.3 mm Hg ) . NIF alone and in combination did not modify the diuresis-natriuresis observed with the previous treatment , whereas HCTZ alone and in combination always increased diuresis ( by 25 % ) and natriuresis ( by 53 % ) . There was a significant negative correlation ( r = -0.71 , p blood pressure ( BP ) reduction induced by the drug administered first ( NIF or HCTZ ) and the additional BP reduction obtained by the association of the second drug . CONCLUSIONS In most of the SSH the NIF-GITS was more potent than HCTZ . NIF did not modify the diuretic-natriuretic effect of PL and of HCTZ . The greater potency of NIF may explain why in most patients the combination HCTZ to NIF induced a lower hypotensive effect than that of the association of NIF to HCTZ . Independently of the sequence of the drug administration , the lower the hypotensive effect of the drug administered first the greater the additional hypotensive effect that was observed by adding the second drug",
"1 . Thirty-eight patients with mild to moderate essential hypertension ( seated diastolic 95 - 110 mm Hg ) were r and omized double-blind to treatment with either zofenopril ( n = 19 ) or hydrochlorothiazide ( n = 19 ) over a period of 12 weeks . 2 . Office blood pressure , heart rate , side effects and metabolic changes were assessed at the end of the run-in period on placebo and after 4 , 8 , 12 weeks treatment at the same time , 22 - 24 h after the last dosing . Ambulatory recordings over 14 h ( 8 h to 22 h ) were performed at the end of placebo period and after active treatment for 12 weeks . 3 . The two regimes reduced office blood pressures equally with minimal additional effect seen on increasing the dose . Both zofenopril and hydrochlorothiazide lowered average baseline ambulatory blood pressure , but zofenopril had greater efficacy in reducing BP during some working hours . 4 . Adverse reactions were mild and transient with both drugs . There were no significant changes in laboratory values . 5 . Thus hydrochlorothiazide and zofenopril given once daily at low dosage both reduce office and ambulatory blood pressures and are well tolerated",
"BACKGROUND Thiazides are recommended to initiate antihypertensive drug treatment in black subjects . OBJECTIVE To test the efficacy of this recommendation in a South African black cohort . METHODS Men and women ( N = 409 ) , aged 18 to 70 years , with a mean ambulatory daytime diastolic blood pressure between 90 and 114 mm Hg , were r and omized to 13 months of open-label treatment starting with the nifedipine gastrointestinal therapeutic system ( 30 mg/d , n = 233 ) , sustained-release verapamil hydrochloride ( 240 mg/d , n = 58 ) , hydrochlorothiazide ( 12.5 mg/d , n = 58 ) , or enalapril maleate ( 10 mg/d , n = 60 ) . If the target of reducing daytime diastolic blood pressure below 90 mm Hg was not attained , the first-line drugs were titrated up and after 2 months other medications were added to the regimen . RESULTS While receiving monotherapy ( 2 months , n = 366 ) , the patients ' systolic and diastolic decreases in daytime blood pressure averaged 22/14 mm Hg for nifedipine , 17/11 mm Hg for verapamil , 12/8 mm Hg for hydrochlorothiazide , and 5/3 mm Hg for enalapril . At 2 months the blood pressure of more patients treated with nifedipine was controlled : 133 ( 63.3 % , P verapamil , 21 ( 40.4 % ) receiving hydrochlorothiazide , and 11 ( 20.8 % ) receiving enalapril . At 13 months ( n = 257 ) , more patients ( P nifedipine ( 94/154 [ 61.0 % ] ) or verapamil ( 22/35 [ 62.9 % ] ) than hydrochlorothiazide ( 10/39 [ 25.6 % ] ) or enalapril ( 1/29 [ 3.4 % ] ) . A sustained decrease of left ventricular mass ( P blood pressure and reduce left ventricular mass",
"OBJECTIVES The present study investigated whether initiating therapy with a combination of losartan ( L ) and hydrochlorothiazide ( HCTZ ) allows for faster blood pressure ( BP ) control and fewer medications than the usual stepped-care approach in patients with stage 2 or 3 hypertension and ambulatory systolic hypertension . METHODS Patients with a mean daytime systolic ambulatory BP ( ABP ) of 135 mmHg or higher were r and omly assigned to receive L 50 mg plus HCTZ 12.5 mg titrated to L 100 mg plus HCTZ 25 mg versus HCTZ 12.5 mg plus atenolol 50 mg . Amlodipine 5 mg was then added , if needed , to achieve a BP goal of less than 130 mmHg . Treatment titration was based on ABP . RESULTS Significantly more patients r and omly assigned to L/HCTZ ( 63.5 % ) than stepped-care ( 37.5 % ; P=0.008 ) achieved the primary end point ( daytime systolic BP of less than 130 mmHg ) . Initial L/HCTZ induced significantly greater decreases in ABP during each 24 h period after six weeks of therapy . Although reductions in systolic and diastolic ABP were not statistically different at the end of the study , ABP reduction was significantly greater ( P L/HCTZ-based regimen . Twice as many patients in the L/HCTZ group achieved the goal ABP with no more than two drugs ( 30.0 % versus 14.7 % ; P=0.03 ) . Moreover , tolerability was significantly better ( P=0.006 ) in the L/HCTZ group , with a 40.0 % incidence of adverse events , versus 65.6 % in the stepped-care group . CONCLUSION Initiating antihypertensive therapy with the combination of L/HCTZ in patients with stage 2 or 3 hypertension and ambulatory systolic hypertension reaches a target BP faster in a higher proportion of patients , with fewer adverse events and less need for a third drug regimen than the conventional stepped-care approach",
"OBJECTIVES We sought to determine the efficacy of isradipine in reducing left ventricular ( LV ) mass and wall thickness in hypertensive patients . BACKGROUND LV hypertrophy on the echocardiogram is a strong predictor of cardiovascular events . Reduction of LV mass may be a desirable goal of drug therapy for hypertension . However , although thiazide diuretic drugs have been advocated as first-line therapy for hypertension , their efficacy in reducing LV mass has been question ed . METHODS Patients with mild to moderate diastolic hypertension and LV mass in excess of 1 SD of normal values were r and omized to isradipine ( n = 89 ) or hydrochlorothiazide therapy ( n = 45 ) . Evaluations were obtained at baseline , after 3 and 6 months of treatment and 2 weeks after treatment was stopped . RESULTS At 6 months , LV mass decreased by 43 + /- 45 g ( mean + /- SD ) with hydrochlorothiazide ( p isradipine ( p = NS ; between-group comparison , p LV mass remained 24 + /- 41 g lower than that at baseline in the hydrochlorothiazide group ( p = 0.003 ) but only 7 + /- 50 g lower in the isradipine group ( p = NS ) . Septal and posterior wall thicknesses were significantly and equally reduced with both isradipine and hydrochlorothiazide . Greater LV mass reduction with hydrochlorothiazide was related to a 2.8 + /- 3.3-mm reduction of LV cavity size with hydrochlorothiazide but no reduction with isradipine . At 6 months of treatment , diastolic blood pressure ( BP ) by design was equally reduced in both treatment groups . At 3 months , systolic BP was reduced by 17 + /- 15 mm Hg with isradipine and by 26 + /- 15 and 25 + /- 17 mm Hg at 3 and 6 months , respectively , with hydrochlorothiazide ( p = 0.003 , between-group comparison ) . However , on stepwise multivariable regression analysis , treatment selection ( partial r2 = 0.082 , p = 0.001 ) , change in average 24-h systolic BP ( partial r2 = 0.032 , p = 0.029 ) and change in average sitting systolic BP ( partial r2 = 0.017 , p = 0.096 ) were predictive of LV mass reduction . CONCLUSIONS Despite an equivalent reduction of diastolic BP , 6 months of therapy with hydrochlorothiazide is associated with a substantial reduction of LV mass , greater than that with isradipine . The superior efficacy of hydrochlorothiazide for LV mass reduction is associated with a greater reduction of systolic BP as well as drug selection itself . These data may have important therapeutic implication",
"The Multiple Risk Factor Intervention Trial ( MRFIT ) is a r and omized primary prevention trial that tested the effect of a multifactor intervention program on coronary heart disease ( CHD ) mortality in 12,866 high-risk men aged 35 - 57 years . Men were r and omly assigned to either a special intervention ( SI ) program , which consisted of dietary advice for lowering blood cholesterol levels , counseling aim ed at cessation for cigarette smokers , and stepped-care treatment for hypertension for those with elevated blood pressure , or to their usual sources of health care within the community ( UC ) . Among the 12,866 r and omized men , 8,012 ( 62 % ) were hypertensive at baseline . For this subgroup , mortality rates with 10.5 years of follow-up were lower for the SI than for the UC group by 15 % ( p = 0.19 ) for CHD and 11 % ( p = 0.13 ) for all causes . These results reflected more favorable outcomes for SI compared with UC hypertensive men during the 3.8 posttrial years ( March 1982 through December 1985 ) than during the preceding 6 - 8 years ( through February 1982 ) . During the posttrial years , death rates were lower for SI than for UC men by 26 % ( p = 0.09 ) for CHD and 23 % ( p = 0.02 ) for all causes . For those with diastolic blood pressure equal to or more than 100 mm Hg , this posttrial trend was a continuation of a trend during the trial ; therefore , with 10.5 years of follow-up , death rates were markedly lower for SI than for UC by 36 % ( p = 0.07 ) for CHD and 50 % ( p = 0.0001 ) for all causes . Similarly , for those without baseline resting electrocardiographic abnormalities , the favorable posttrial outcome for the SI group was a continuation of a trend during the trial . In contrast , for those with baseline diastolic blood pressure of 90 - 99 mm Hg and for those with baseline resting electrocardiographic abnormalities , the favorable posttrial mortality findings for the SI group were a reversal of unfavorable trends recorded during the trial . Two factors appear to have contributed to this more favorable mortality trend for the SI group : 1 ) a change in the diuretic treatment protocol for SI men about 5 years after r and omization , which involved replacement of hydrochlorothiazide with chlorthalidone at a daily maximum dose of 50 mg ; and 2 ) a favorable effect of intervention on nonfatal cardiovascular events during the trial years . In addition , delay until the full impact of beneficial effects on mortality end points from smoking cessation and cholesterol lowering could have contributed . ( ABSTRACT TRUNCATED AT 400 WORDS",
"In this study , using 24-hour ambulatory blood pressure ( BP ) monitoring , the authors assessed the potential for BP control using hydrochlorothiazide ( HCTZ , 12.5 mg daily ) , given as a monotherapy over 12 months to 49 black South African patients with mild to moderate hypertension ( mean day diastolic blood pressure [ DBP ] > or = 90 and received fixed combination of quinapril/HCTZ 10/12.5 , 20/12.5 , and 20/25 mg , with dose titration at 3 monthly intervals if BP control was not achieved ( day DBP profound and sustained BP reduction was observed at the end of the study . The 24-hour BP decreased from 151 + /- 14/98 + /- 7 to 136 + /- 15/87 + /- 9 mmHg ( p mean day BP decreased from 155 + /- 14/104 + /- 7 to 140 + /- 15/91 + /- 10 mmHg ( p or = 10 mmHg ) rates were 49 % and 61 % , respectively . At the end of the study , only 2 patients ( 4 % ) remained on treatment with HCTZ . Out of the initial 12 patients controlled on HCTZ at 3 months ( 12/49 , 24 % ) , 5 patients remained controlled at 6 months and only 1 patient at 12 months . In contrast , quinapril/HCTZ combinations maintained their antihypertensive effect up to 9 months , with a significant number of patients ( 22/49 , 45 % ) requiring the highest dose of the combination ( 20/25 mg daily ) . In conclusion , low-dose HCTZ should not be recommended as monotherapy in black patients with mild to moderate hypertension due to the fact that the BP-lowering effect is attenuated already at 6 months of treatment , with most patients requiring the addition of the ACE inhibitor",
"We compared the effects of atenolol ( 50 mg ) , amlodipine ( 5 mg ) , enalapril ( 20 mg ) , hydrochlorothiazide ( 25 mg ) , and losartan ( 50 mg ) given in once-daily oral doses on office and ambulatory blood pressures ( BPs ) in patients with hypertension and obstructive sleep apnea ( OSA ) . Each of 40 r and omized patients was treated in sequence with two of the five agents ( balanced incomplete block design ) . Treatment periods lasted 6 wk and were separated by a 3-wk washout period . Changes in BP from baseline with the study substances were compared through analysis of variance . Office diastolic BP , our primary outcome variable , was most effectively lowered by atenolol , with all four post hoc differences between atenolol and the remaining substances being statistically significant . Reductions in office systolic and daytime ambulatory BP were not significantly different among the five compounds . However , atenolol reduced mean nighttime ambulatory diastolic and systolic BP more effectively than did amlodipine , enalapril , or losartan ( but not hydrochlorothiazide ) . Severity of sleep-disordered breathing and well-being during the day were not significantly influenced by any of the study compounds . Our findings are in accordance with the hypothesis that an overactivity of the sympathetic nervous system is an important mechanism behind the development or maintenance of hypertension in patients with OSA",
"BACKGROUND Differences between the antihypertensive responses to drug therapy measured by office blood pressure ( OBP ) and ambulatory blood pressure monitoring ( ABPM ) techniques have been noted but rarely analyzed . We studied whether the OBP and 24-h ABPM responses to hydrochlorothiazide differ and , if so , the relevance of these differences . METHODS The OBP and ABPM responses to hydrochlorothiazide ( 25 mg/d , for 4 weeks ) were measured in 228 subjects with essential hypertension , and mean responses were compared between methods using the Student paired t test . To assess variation in the agreement between OBP and ABPM responses among subjects , the limits of agreement were calculated as the mean difference between OBP and ABPM responses + /-2 st and ard deviations . RESULTS The mean systolic OBP response was 4.8 mm Hg greater than the response measured by ABPM ( -14.3 v -9.5 mm Hg , P diastolic OBP response was 2.1 mm Hg greater than the response measured by ABPM ( -7.5 v -5.5 , P OBP and ABPM responses ranged from -18.7 to + 28.2 mm Hg for systolic response and from -12.9 to + 17.1 mm Hg for diastolic response . The systolic and diastolic OBP and ABPM responses were in opposite directions in 22.8 % and 23.7 % of the subjects , respectively . CONCLUSIONS Compared to ABPM , OBP overestimates the mean systolic and mean diastolic blood pressure responses to hydrochlorothiazide . Variation among subjects in the magnitude and direction of responses renders OBP an unreliable predictor of ABPM responses",
"During a 12-week , multicenter study to evaluate the efficacy and safety of lisinopril and hydrochlorothiazide ( HCTZ ) for the treatment of obesity-related hypertension , ambulatory blood pressure ( ABP ) monitoring was performed both at baseline and at study completion in 124 patients . Patients were r and omized to three groups : placebo , lisinopril ( 10 , 20 , or 40 mg/day ) , or HCTZ ( 12.5 , 25 , or 50 mg/day ) . All groups were matched with regard to sex , race , age , body mass index , and waist/hip ratio . The primary analysis of ABP data revealed that both lisinopril and HCTZ effectively lowered mean 24-h systolic ( SBP ) and diastolic ( DBP ) blood pressure compared with placebo , ( mean change from baseline SBP/DBP : -12.0/-8.2 , -10.6/-5.5 , and -0.3/-0.5 mm Hg , respectively ) ; however , lisinopril lowered DBP better than HCTZ ( P responded better to lisinopril than HCTZ ( -11.9/-7.3 v -6.6/-3.5 mm Hg , respectively ) , whereas women responded well to both drugs . White patients responded better to lisinopril than HCTZ , whereas black patients showed a significant response to HCTZ only . Response to treatment was also influenced by patient classification of 24-h blood pressure profiles , ie , \" dipper \" or \" nondipper . \" Overall , the majority of obese hypertensives were nondippers . Nondippers ( n = 82 ) responded well to both drugs ( -10.4/-6.9 v -12.5/-5.7 mm Hg , P lisinopril ( -11.7/ -9.4 mm Hg , P HCTZ ) , but not HCTZ ( -5.6/-4.1 mm Hg , P = NS v placebo ) . Results of 24-h ABP data show that both lisinopril and HCTZ are effective therapies for obesity-related hypertension and that response to treatment is influenced by sex , race , and dipper/nondipper status",
"Angiotensin-converting enzyme inhibitors combined with higher doses of hydrochlorothiazide ( HCT ) , that is , 25 mg daily , have been recognized as an effective form of antihypertensive therapy . To evaluate the coadministration of 20 mg ramipril with 25 mg HCT , we carried out a r and omized , double-blind , controlled trial with two dose schedules of ramipril ( 20 mg q.d . and 10 mg b.i.d . ) and HCT monotherapy arms as comparators in 354 patients with stage 2 hypertension . The clinic blood pressure ( BP ) was assessed using a semiautomatic digital device and 24-h BP was measured using ambulatory BP recordings at baseline and after 8 weeks of therapy . At baseline , the demographics and baseline BP values were similar in the four treatment groups ( age : 51–53 years , 52–58 % male , 64–68 % non-black , clinic BP : 155–158/103–104 mm Hg ) . Ramipril – HCT induced significantly greater reductions in both the clinic and ambulatory BP than the HCT and ramipril monotherapy treatments ( for example , additional reductions in ambulatory BP on ramipril-HCT ranged from −7.3/−5.2 to −10.3/−7.4 mm Hg compared to the monotherapies , all P Reductions from baseline were still numerically greater for the clinic BPs derived from device measurements than those for the BP values derived from 24-h ambulatory BP measurements ( changes in clinic diastolic BP ranged from −8.5 to −15.5 mm Hg across treatment groups , whereas changes in ambulatory diastolic BP were −4.7 to −12.0 mm Hg for the same groups ) . Thus , these data support the use of ambulatory BP monitoring even when automated BP devices are used for the assessment of clinical BP in trials that attempt to differentiate BP responses among active comparator groups . In conclusion , based on its efficacy and tolerability profile the combination of ramipril and HCT was shown to be effective therapy for the treatment of stage 2 hypertension",
"OBJECTIVES To assess , using ambulatory blood pressure monitoring ( ABPM ) , the antihypertensive efficacy of hydrochlorothiazide 12.5 mg and indapamide 2.5 mg given as a monotherapy over 3 months to black patients with mild to moderate essential hypertension . DESIGN Single-centre , prospect i ve , r and omised open pilot study in three phases : ( i ) 1-week drug-free washout period ; ( ii ) 2-week placebo run-in phase ; and ( iii ) 3-month prospect i ve open-label active treatment period . RESULTS Forty-two black patients with mean daytime diastolic BP ( DBP ) > or = 90 mmHg and Overall , a profound and sustained BP reduction was achieved with indapamide at 3 months ( N = 20 ) . The 24-hour BP decreased from 150 + /- 17/94 + /- 6 mmHg to 130 + /- 19/82 + /- 9 mmHg ( P systolic BP ( SBP ) and DBP at 3 months versus baseline ) ; the mean daytime BP decreased from 155 + /- 15/98 + /- 6 mmHg to 134 + /- 18/87 + /- 10 mmHg ( P SBP and DBP at 3 months versus baseline ) . The overall control ( mean daytime DBP or = 10 mmHg ) rates achieved with indapamide were 10/20 ( 50 % ) and 13/20 ( 65 % ) , respectively . In contrast , monotherapy with hydrochlorothiazide result ed in more modest BP reduction and control and response rates at 3 months ( N = 22 ) . The 24-hour BP decreased from 147 + /- 14/94 + /- 7 mmHg to 139 + /- 19/88 + /- 2 mmHg ( P mean daytime BP decreased from 151 + /- 14/98 + /- 5 mmHg to 144 + /- 16/93 + /- 10 mmHg ( P hydrocholorothiazide and indapamide caused significant hypokalaemia . CONCLUSIONS Monotherapy with indapamide is associated with greater BP reduction and control and response rates than monotherapy with low-dose hydrochlorothiazide and may be an appropriate choice of antihypertensive diuretic therapy in black South African patients with mild to moderate hypertension",
"PURPOSE Treatment of hypertension in the elderly decreases cardiovascular morbidity and mortality . We hypothesized that nitrendipine would be efficacious in the treatment of hypertension in the elderly . We evaluated potential differences between nitrendipine and the commonly used drug hydrochlorothiazide ( HCTZ ) . PATIENTS AND METHODS The study was conducted as a double-blind r and omized clinical trial of nitrendipine or HCTZ . Thirty hypertensive subjects over age 60 with a median sitting blood pressure greater than or equal to 95 mm of Hg were recruited into the study . A diastolic blood pressure with treatment of less than 95 mm Hg with a 5 mm Hg or greater decrease from baseline was considered a successful response . RESULTS Nitrendipine decreased mean ( + /- SEM ) blood pressure from 163 + /- 3/102 + /- 1 to 142 + /- 2/89 + /- 2 mm Hg , and HCTZ decreased it from 164 + /- 4/102 + /- 1 to 143 + /- 5/91 + /- 2 mm Hg . A greater proportion of patients had a successful response with nitrendipine ( 81 percent ) than with HCTZ ( 64 percent ) . The antihypertensive effect of nitrendipine twice daily appeared to be sustained for 24 hours . Blood pressure response to exercise was attenuated with both drugs . HCTZ caused gout , leg pains , muscle aches , hypokalemia , increased uric acid levels , and increased total cholesterol and triglyceride levels . Nitrendipine caused edema and tachycardia . CONCLUSION Nitrendipine significantly reduces blood pressure with few side effects and no adverse metabolic effects , and offers a reasonable alternative for treating hypertension in the elderly",
"BACKGROUND The efficacy of losartan ( L ) in combination with hydrochlorothiazide ( HCTZ ) has been demonstrated to reduce blood pressure . However , there are limited data on the effects of L/HCTZ combinations versus HCTZ monotherapies in reducing ambulatory systolic blood pressure . The aim of this study was to compare the effects of these treatment approaches in patients with ambulatory systolic hypertension . METHODS Patients were r and omized to receive L 50 mg ( n = 60 ) or HCTZ 12.5 mg ( n = 60 ) for 6 weeks . Patients were then force-titrated to L 50/HCTZ 12.5 mg and to L 100/HCTZ 25 mg or were sham-titrated to HCTZ 12.5 mg and force-titrated to HCTZ 25 mg , respectively . Clinic and 24-h ambulatory blood pressure ( ABP ) were measured at baseline and after each 6-week treatment period . RESULTS We found that L 50 and HCTZ 12.5 induced significant and similar decreases in clinic and ABP . The combinations of L 50/HCTZ 12.5 and L 100/HCTZ 25 provided significantly greater decreases in clinic and ABP than did HCTZ monotherapies . The L 50/HCTZ 12.5 and L 100/HCTZ 25 combinations provided significant additional decreases in systolic/diastolic ABP during daytime ( -5.3/-2.0 mm Hg ; P ABP reductions . CONCLUSIONS Combinations of L 50/HCTZ 12.5 and L 100/HCTZ 25 provided greater reductions in clinic and ABP than HCTZ monotherapies , with a clear dose-response relationship with regard to ABP . These results support the use of ABP monitoring when assessing the efficacy of antihypertensive therapies",
"BACKGROUND Only a minority of hypertensive individuals is adequately controlled for their hypertension , partially because reliable predictors for efficient antihypertensive drug therapy are lacking . METHODS In a prospect i ve , r and omized , double-blind , cross-over , placebo-controlled study ( The GENRES Study ) , 208 moderately hypertensive Finnish men ( aged 35 to 60 years ) were treated for 4 weeks with antihypertensive drugs from four different classes : amlodipine ( 5 mg ) , bisoprolol ( 5 mg ) , hydrochlorothiazide ( 25 mg ) , or losartan ( 50 mg ) daily . Each individual received each of the four monotherapies in a r and omized order . Four-week placebo periods were included before and between drug treatment periods . Antihypertensive responses were assessed with 24-h ambulatory and office measurements and analyzed according to age , body mass index , triceps skin fold thickness , waist-to-hip ratio , duration of hypertension , number of previous antihypertensive drugs , number of affected parents , and blood pressure ( BP ) levels , and profiles during placebo periods . RESULTS The median BP responses in 24-h ambulatory recordings ( systolic/diastolic ) were 11/8 mm Hg for bisoprolol , 9/6 mm Hg for losartan , 7/5 mm Hg for amlodipine , and 5/2 mm Hg for hydrochlorothiazide . The highest pairwise within-subject correlations in BP responses were seen for the combinations of bisoprolol-losartan and amlodipine-hydrochlorothiazide . The BP responses to bisoprolol and losartan did not vary according to the variables . Amlodipine and hydrochlorothiazide responses were positively correlated with age , placebo BP level , and lower night-time dipping on placebo . CONCLUSIONS Baseline clinical and BP parameters may be used to predict the efficacy of antihypertensive therapies . The GENRES Study material should provide an excellent platform for future pharmacogenetic analyses of antihypertensive drug responsiveness",
"Aim : We investigated the efficacy and safety of daily c and esartan 8/16 mg and hydrochlorothiazide 12.5 mg as monotherapy and in combination in older patients with systolic hypertension . Methods : The study used a double-blind r and omized placebo-controlled crossover design . Treatment phases were of 6 weeks duration . For inclusion , patients were aged 55 - 84 years with sitting systolic blood pressure ( SBP ) 160 - 210 mmHg and diastolic blood pressure ( DBP ) Major findings : Compared with the placebo phase , clinic and ambulatory SBP was significantly reduced with both dose-adjusted c and esartan and fixed-dose hydrochlorothiazide as monotherapy , the effect of c and esartan being greater than that of hydrochlorothiazide . In combination , the effects of the two drugs were additive . Both drugs were well tolerated either as monotherapy or in combination . Conclusion : Both c and esartan and a low dose of hydrochlorothiazide are effective and well-tolerated antihypertensive agents in isolated systolic hypertension with additive effects in combination . C and esartan was more effective than hydrochlorothiazide , although it is possible that dose adjustment only of c and esartan could have enhanced its relative effectiveness",
"The efficacy of low dose ( 12.5 to 25 mg daily ) hydrochlorothiazide ( HCTZ ) was evaluated by ambulatory blood pressure monitoring ( ABPM ) in 19 mild to moderate hypertensive ( mean daytime 12-h diastolic BP > or = 90 mm Hg and After a 3-week placebo run-in period , HCTZ was administered for 8 weeks as monotherapy . The mean daytime ABPM was reduced from 159 + /- 13/105 + /- 6 to 145 + /- 11/97 + /- 10 mm Hg ( P BP control . The 24-h BP load fell from 69 % at baseline , to 53 % with 12.5 mg HCTZ and to 47 % with 25 mg HCTZ daily . There were no side effects but the increase of HCTZ to 25 mg daily was followed by adverse changes ( P serum potassium levels . It is concluded that low dose of HCTZ monotherapy has only a moderate effect on the BP control and 24-h BP load while the higher 25 mg dose is associated with significant decrease in serum potassium level",
"The benefit of antihypertensive therapy in reducing cardiovascular morbidity and mortality associated with isolated systolic hypertension has now been established by the Systolic Hypertension in the Elderly Program . However , there is little information about the relative effectiveness of different drug regimens in this condition . This study compared the efficacy and tolerability of 50 mg of atenolol , 10 mg of enalapril , 25 mg of hydrochlorothiazide and 2.5 mg of isradipine in the treatment of isolated systolic hypertension . After a 3-week placebo run-in phase , 24 subjects were r and omized into a 4-period double-blind crossover study by use of an orthogonal latin square design . Treatment periods were of 6 weeks ' duration with titration to a higher dose after 4 weeks in those not reaching goal blood pressure ( BP ) . Each active treatment was followed by a 3-week placebo washout . Casual clinic and 24-hour ambulatory BP ( Accutracker II ) were measured at the end of each treatment phase . Routine biochemistry was also performed after the placebo run-in , at the end of each active treatment phase , and after the placebo run-out . Of the 24 subjects entered ( mean age 72.3 years , 38 % men ) 20 completed the whole study . Mean + /- st and ard deviation of supine clinic and daytime ambulatory BP on entry were 181/79 + /- 21/9 mm Hg and 165/82 + /- 23/15 mm Hg , respectively . All drugs reduced mean casual and ambulatory BP significantly relative to placebo but only hydrochlorothiazide and enalapril produced a consistent hypotensive effect throughout the entire 24-hour period . Isradipine and enalapril exhibited a relatively greater effect on reducing systolic BP than either hydrochlorothiazide or atenolol . ( ABSTRACT TRUNCATED AT 250 WORDS",
"This study evaluated the anti-hypertensive efficacy , tolerability and effects on left ventricular mass of losartan , a selective angiotensin II receptor antagonist , after 22 months in patients with essential hypertension . The study included 77 hypertensive patients who were r and omised at baseline to 22 months double-blind once-daily treatment with losartan 50 mg ( L group n = 44 patients , mean age 54 ± 9 years ) or hydrochlorothiazide 25 mg ( HCTZ group , n = 33 patients , mean age 56 ± 7 years ) . Routine haematology , blood chemistry , st and ard electrocardiography , echocardiography and ambulatory non-invasive 24-h blood pressure ( BP ) monitoring were performed at baseline and after 10 and 22 months . The results showed good tolerability and a significant mean systolic and diastolic BP reduction in all groups ( L group : 22 mm Hg and 11 mm Hg ; HCTZ group : 11 mm Hg and 7 mm Hg , respectively for systolic and diastolic mean BP ) . Moreover , a remarkable reduction in left ventricular mass index was reached after 10 and 22 months only in the L group ( L group : Δ = –11 g/m2 , P a significant reduction in BP and left ventricular mass in hypertensive",
"Recent studies and authorities have advocated the use of low-dose thiazide diuretics as first-line treatment agents in elderly hypertensives . However , these recommendations were based solely on blood pressure ( BP ) measured in the clinic . The objective of the present 32-week double-blind study was to compare the effects of hydrochlorothiazide ( HCTZ ) and amlodipine ( AML ) in elderly patients with confirmed ambulatory hypertension . After a 4-week placebo washout period , 42 ( 25 men , 17 women ) patients ( mean age , 69 years ) with clinic sitting diastolic BP of 95 to 114 mm Hg and daytime ambulatory diastolic BP of > or = 90 mm Hg were r and omized double-blind to receive AML 5 to 10 mg ( n = 21 ) or HCTZ 12.5 to 25 mg ( n = 21 ) once daily . After 8 weeks of monotherapy , patients in whom clinic diastolic BP remained > or = 90 mm Hg were given combination therapy with the other agent . Amlodipine monotherapy induced significant reductions in clinic , mean 24-h , daytime and sleep systolic/diastolic BPs whereas only clinic BP decreased significantly in patients treated with HCTZ monotherapy . Moreover , 19/21 versus 8/21 patients on AML and HCTZ monotherapies achieved adequate BP control . At the end of the 32-week treatment period , combination therapy in the HCTZ group result ed in statistically significant reductions in clinic as well as in 24-h , daytime and sleep ambulatory BPs that were similar to those observed in the AML monotherapy group . In conclusion , the administration of AML monotherapy induced significant reductions in both clinic and ambulatory BPs in elderly patients whereas only clinic BP was significantly decreased by HCTZ monotherapy . Moreover , the addition of AML to HCTZ in patients inadequately controlled by monotherapy has permitted statistically significant decrements in clinic as well as in ambulatory BP . Consequently , the results of the present study suggest that the use of HCTZ in doses of up to 25 mg daily is inadequate for ambulatory BP control in the elderly despite official recommendations",
"The antihypertensive effects of four different antihypertensive medications ( beta-blocking agent , atenolol 50 mg ; calcium-antagonist , isradipine SRO [ slow release ] 2.5 mg ; diuretic , hydrochlorothiazide [ HCTZ ] 25 mg ; and angiotension converting enzyme-inhibitor , spirapril 6 mg ) on obese patients with sleep disordered breathing and hypertension were compared by the ambulatory blood pressure measurement ( ABPM ) . Eighteen patients were r and omized in a double-blind , crossover fashion to receive each of the four different medications for 8 weeks . ABPM was performed at baseline and after an 8-week treatment with these medications . A 2- to 3-week washout period occurred both at baseline and between each of the four medications . Three patients were omitted from statistical analysis because of technical problems of ABPM . Atenolol , isradipine SRO , and spirapril decreased significantly ( P mean 24-h systolic blood pressure , whereas HCTZ did not . The mean 24-h diastolic blood pressure decreased significantly after all four medications : 12 ( SD+/-14 ) mm Hg with atenolol , 7 ( SD+/-10 ) mm Hg with isradipine SRO , 3 mm Hg ( SD+/-14 ) with HCTZ , and 6 ( SD+/-15 ) mm Hg with spirapril ( P mean diastolic or systolic blood pressure significantly . According to the 24-h blood pressure curve the influence of these four medications during the whole measurement period was not similar . Atenolol and spirapril lost their antihypertensive effect during the early morning hours . The antihypertensive effect of HCTZ varied markedly from hour to hour . The trough-to-peak ratio of no medication was > 0.50 . Negative correlation was observed between the apnea time and the mean systolic 24-h ( r = -0.604 , P = NS ) and the mean systolic nocturnal blood pressure change ( r = -0.590 , P = NS ) . Our study revealed that the daytime high blood pressure was quite easily controlled by the ordinary monotherapy in these patients with partial upper airway obstruction and hypertension . Instead none of the medications used decreased nocturnal high blood pressure markedly",
"BACKGROUND Blood pressure ( BP ) is controlled by a variety of systems , the activities of which vary throughout the day . As drugs are developed that selectively block these systems , the fall in BP may not be consistent over 24 h. METHODS A total of 24 patients ( aged > 65 years ) with systolic BP ( SBP ; > 150 mm Hg ) that had not been treated entered a sub study of a larger study performed in 74 patients . In a double blind , crossover study with a balanced design , they received placebo , atenolol 50 mg , perindopril 8 mg , felodipine 10 mg , or hydrochlorothiazide 50 mg . The study periods were 2 months . Ambulatory BP monitoring was performed at the end of each period , and was divided into awake periods ( 9:00 AM to 10:00 PM ) , sleep periods ( 12:00 AM to 6:00 AM ) , and morning periods ( 6:00 AM to 9:00 AM ) . Medication was taken at 9:00 AM . RESULTS The four drug classes lowered 24-h mean SBP ( P fall with atenolol was less than with the other drugs . The fall in awake BP with perindopril was less than with felodipine or hydrochlorothiazide . Atenolol caused no significant fall in sleep or morning SBP , and the falls with the other three drugs were significant and were greater than the fall with atenolol . The fall in sleep BP with perindopril was greater than with the other drug classes . The awake-sleep difference in SBP increased with perindopril , stayed the same with felodipine and hydrochlorothiazide , and was reduced by atenolol . CONCLUSIONS In this study , the response to the different drug classes differed . The response to drugs that work relatively nonspecifically ( diuretics , calcium blockers ) was relatively consistent over 24 h. The response to beta blockers and to angiotensin converting enzyme inhibitors reflected the activity of control systems . This finding supports the concept of multiple drug therapy that may need to be tailored to the time of day",
"Objective To compare with placebo the efficacies of once-daily administrations of lacidipine and hydrochlorothiazide separately and in combination to elderly patients with systolic hypertension . Design and methods Nineteen elderly subjects ( five men and 14 women , median age 71 years , range 62–79 years ) participated in the study , which had a r and omized double-blind crossover design . For each subject there were four treatment phases , each of duration 4 weeks . The initial treatments in each phase were 2 mg lacidipine once a day and 25 mg hydrochlorothiazide once a day , separately and in combination , and placebo . Doses of each agent could be doubled after 2 weeks in each phase if the patient 's goal systolic blood pressure had not been achieved . The numbers of subjects administered the higher dose of each treatment were 13 for placebo , 14 for lacidipine , 11 for hydrochlorothiazide and eight for lacidipine plus hydrochlorothiazide . Results End-of-phase mean clinic blood pressures were 164/85 mmHg with placebo , 159/82 mmHg with lacidipine , 157/84 mmHg with hydrochlorothiazide and 152/82 mmHg with lacidipine plus hydrochlorothiazide . Systolic blood pressure was significantly reduced during all active treatment phases compared with placebo and that for the lacidipine plus hydrochlorothiazide phase was also significantly less than those for both of the other active treatment phases . There was no difference between sitting and st and ing blood pressure for any phase . Factorial analysis of the main effects of treatment indicated that the effects of lacidipine and hydrochlorothiazide on clinic blood pressure were additive and also that heart rate was higher when hydrochlorothiazide had been administered . Ambulatory blood pressure monitoring confirmed the pattern of the responses of blood pressure and showed that administration of hydrochlorothiazide had a significantly greater effect on systolic blood pressure and a longer duration of action than did administration of lacidipine . There was no difference in the frequency of adverse effects among any of the phases . Conclusions In treating elderly systolic hypertensives the diuretic hydrochlorothiazide is a more effective antihypertensive agent with a longer duration of action than is the calcium channel antagonist lacidipine . In combination the effects of these two drugs on blood pressure are additive",
"Objective Individual blood pressure responses to antihypertensive therapy are difficult to predict . To improve optimization of antihypertensive therapy , we analyzed correlations of relevant laboratory tests with blood pressure responses to four antihypertensive monotherapies . Methods In the GENRES study , 208 Finnish men aged 35–60 years with moderate hypertension used amlodipine 5 mg , bisoprolol 5 mg , hydrochlorothiazide 25 mg and losartan 50 mg daily , each for 4 weeks as a monotherapy in a double-blind , r and omized , placebo-controlled crossover study ; that is , each subject received each type of monotherapy in a r and om order . The treatment periods were preceded and separated by 4-week placebo periods . Ambulatory 24-h and office blood pressure measurements were carried out after all study periods . Data from several biochemical tests were correlated to antihypertensive drug responses . Results Serum total calcium concentration was negatively correlated with blood pressure responses to amlodipine ( P values 0.001–0.002 ) . Plasma renin activity was positively correlated with blood pressure responses to losartan ( P values 0.001–0.005 ) and bisoprolol ( P values 0.03–0.17 ) , and negatively with blood pressure responses to hydrochlorothiazide ( P values 0.01–0.07 ) . Daily urinary excretion of sodium was negatively correlated with ambulatory blood pressure responses to amlodipine ( P values 0.001–0.01 ) . Conclusions In this carefully controlled study , marked individual variations in antihypertensive drug responsiveness were found to correlate to several baseline laboratory parameters . The negative correlation between serum calcium levels and amlodipine responses is intriguing and suggests an underlying mechanistic association . Collectively , our data imply that laboratory tests may have some value in prediction of the efficacy of various antihypertensive drug therapies , although great patient-to-patient variation remains an obstacle for exact predictive classification",
"Background and Purpose — The Plaque Hypertension Lipid-Lowering Italian Study ( PHYLLIS ) tested whether ( 1 ) the angiotensin-converting enzyme ( ACE ) inhibitor fosinopril ( 20 mg per day ) was more effective on carotid atherosclerosis progression than the diuretic hydrochlorothiazide ( 25 mg per day ) , ( 2 ) pravastatin ( 40 mg per day ) was more effective than placebo when added to either hydrochlorothiazide or fosinopril , and ( 3 ) there were additive effects of ACE inhibitor and lipid-lowering therapies . Methods — A total of 508 hypertensive , hypercholesterolemic patients with asymptomatic carotid atherosclerosis were r and omized to : ( A ) hydrochlorothiazide ; ( B ) fosinopril ; ( C ) hydrochlorothiazide plus pravastatin ; and ( D ) fosinopril plus pravastatin , and followed up blindly for 2.6 years . B-Mode carotid scans were performed yearly by certified sonographers in 13 hospitals and read central ly . Corrections for drift were calculated from readings repeated at study end . Primary outcome was change in mean maximum intima-media thickness of far and near walls of common carotids and bifurcations bilaterally ( CBMmax ) . Results — CBMmax significantly progressed ( 0.010±0.004 mm per year ; P=0.01 ) in group A ( hydrochlorothiazide alone ) but not in groups B , C , and D. CBMmax changes in groups B , C , and D were significantly different from changes in group A. Changes in group A were concentrated at the bifurcations . “ Clinic ” and “ ambulatory ” blood pressure reductions were not significantly different between groups , but total and low-density lipoprotein cholesterol decreased by ≈1 mmol/L in groups C and D. Conclusions — Progression of carotid atherosclerosis occurred with hydrochlorothiazide but not with fosinopril . Progression could also be avoided by associating pravastatin with hydrochlorothiazide "
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CONTEXT : Late-onset sepsis ( LOS ) is a major cause of mortality and morbidity in preterm infants . Despite various preventive measures , its incidence continues to remain high , hence the urgent need for additional approaches . One such potential strategy is supplementation with probiotics . The up date d Cochrane Review ( 2014 ) did not find benefits of probiotics in reducing the risk of LOS in preterm infants ( 19 studies , N = 5338 ) . Currently there are > 30 r and omized controlled trials ( RCTs ) of probiotics in preterm infants that have reported on LOS . OBJECTIVES : To conduct a systematic review including all relevant RCTs . DATA SOURCES : PubMed , Embase , Cochrane Central Register of Controlled Trials , Cumulative Index of Nursing and Allied Health Literature , and E- abstract s from the Pediatric Academic Society meetings and other pediatric and neonatal conference proceedings were search ed in June and August 2015 . STUDY SELECTION : RCTs comparing probiotics versus placebo/no probiotic were included . DATA EXTRACTION : Relevant data were extracted independently by 3 review ers . RESULTS : Pooled results from 37 RCTs ( N = 9416 ) using fixed effects model meta analysis showed that probiotics significantly decreased the risk of LOS ( 675/4852 [ 13.9 % ] vs 744/4564 [ 16.3 % ] ; relative risk , 0.86 ; 95 % confidence interval , 0.78–0.94 ; P = .0007 ; I2 = 35 % ; number needed to treat , 44 ) . The results were significant even after excluding studies with high risk of bias . CONCLUSIONS : Probiotic supplementation reduces the risk of LOS in preterm infants
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"UNLABELLED The aim of the study is to compare the role of killed ( KP ) Lactobacillus acidophilus with living ( LP ) in reducing incidence of sepsis ( NS ) and necrotizing enterocolitis ( NEC ) in neonates . R and omized double blind placebo study , included 150 neonates admitted to NICU at day 1 , sixty received oral ( LP ) and 60 received ( KP ) and 30 received placebo . One gram of stools was collected on admission , at day 7 , at end of the study , as well as on suspected NEC or NS and was sent for culture . RESULTS LP and KP were preventive factors for NEC with absolute risk reduction ( AAR ) 16 , 15 % , respectively and 18 % for NS compared to placebo . Incidence of NEC and NS did not differ significantly between neonates supplemented with LP and those with KP . Preterm neonates supplemented with KP showed significantly lower incidence of NEC compared to placebo , while incidence of NS showed no significant difference between both groups . There is significant reduction in NS and NEC among neonates with positive Lactobacillus colonization of gut compared to those none colonized at day 7 ( 27.9 vs. 85.9 % , 0 vs. 7.8 % ) and at day 14 ( 48.7 vs. 91.7 % for NS and 0 vs. 20.8 % for NEC ) . Overall comparison between the three groups showed statistical significant reduction in the incidence of NEC . Present conclusions are that early gut colonization with beneficial bacteria lowers the incidence of NEC and NS . KP retained similar benefits to live bacteria",
"Background : The increase in invasive fungal infections ( IFIs ) in neonatal intensive care unit ( NICU ) is jeopardizing the survival of preterm neonates . Probiotics modulating the intestinal microflora of preterm neonates may minimize enteral fungal colonization . Aims : This study was to examine whether probiotic supplementation in neonates reduced fungal septicemia . Material s and Methods : This prospect i ve , r and omized , double blind trial investigating the supplementation of preterm infants with a probiotic was done from May 2012 to April 2013 , with 112 subjects r and omized into two groups . Primary outcome : Decreased fungal colonization in gastrointestinal tract . Others : Incidence of late onset septicemia ; duration of the primary hospital admission ; number of days until full enteral feeds established . Results : Full feed establishment was earlier in probiotics group compared to placebo group ( P = 0.016 ) . The duration of hospitalization was less in the probiotic group ( P = 0.002 ) . Stool fungal colonization , an important outcome parameter was 3.03 ± 2.33 × 105 colony formation units ( CFU ) in the probiotics group compared to 3 ± 1.5 × 105 CFU in the placebo group ( P = 0.03 ) . Fungal infection is less in the study group ( P = 0.001 ) . Conclusion : The key features of our study were reduced enteral fungal colonization , reduce invasive fungal sepsis , earlier establishment of full enteral feeds , and reduced duration of hospital stay in the probiotics group",
"BACKGROUND & AIMS Recent studies have suggested that the gut microflora has metabolic effects . We aim ed to evaluate postnatal growth in preterm infants who received different probiotic supplements , and to assess the safety of probiotic administration . METHODS This prospect i ve , r and omized , double-blind , controlled trial was performed at three tertiary care neonatal units . Preterm infants were r and omly assigned to receive daily supplementation over 4 - 6 weeks with placebo ( group C ) or probiotics ( group P ) . Group P comprised three subgroups : P1 received Bifidobacterium lactis , P2 received Bifidobacterium longum , and P3 received B. lactis and B. longum . We assessed postnatal growth during the supplementation period and up to a corrected gestational age ( GA ) of 41 weeks when body composition was assessed using whole-body dual-energy X-ray absorptiometry . Aerobic and anaerobic blood cultures were performed on suspicion of late-onset sepsis . RESULTS The study comprised 199 preterm infants with a mean GA of 29.1 ± 1.4 weeks and a mean birth weight of 1173 ± 210 g , who received a placebo ( group C , n = 52 ) or probiotics ( group P , n = 147 ) from the first week of life . At the end of the supplementation period , no statistically significant differences were seen between the groups in relation to the mean body weight ( group C = 1906 ± 23 g , group P = 1875 ± 14 g , p = 0.25 ) , length , or head circumference . The incidence rates of necrotizing enterocolitis and late-onset sepsis were similar in the two groups . At the corrected GA of 41 weeks , there were no differences between the groups with respect to anthropometric measurements or body composition analysis . CONCLUSIONS Preterm infants receiving Bifidobacterium supplements did not exhibit better postnatal growth compared with those who received placebo treatment . No adverse effects were associated with probiotic administration . Registered under Clinical Trials.gov Identifier no. NCT01379417",
"BACKGROUND Probiotics have strain specific effects and the effects of fungi in preventing diseases in preterm infants have been investigated poorly . Saccharomyces boulardii is a yeast which acts both as a probiotic and a polyamine producer . AIM The objective of this study was to investigate the efficacy of S. boulardii in preventing necrotizing enterocolitis ( NEC ) or sepsis in very low birth weight infants . STUDY DESIGN AND SUBJECTS A prospect i ve , double blind , placebo controlled trial was conducted in preterm infants ( ≤ 32 GWs , ≤ 1500 g birth weight ) . They were r and omized either to receive feeding supplementation with S. boulardii 50 mg/kg every 12 h or placebo , starting with the first feed until discharged . OUTCOME MEASURES Necrotizing enterocolitis ( NEC ) or sepsis and NEC or death . RESULTS Birth weight and gestational age of the study ( n = 104 ) and the control ( n = 104 ) groups were 1126 ± 232 vs 1162 ± 216 g and 28.8 ± 2.2 vs 28.7 ± 2.1 weeks , respectively . Neither the incidence of stage ≥ 2 NEC or death nor stage ≥ 2 NEC or late onset culture proven sepsis was significantly lower in the study group when compared with the control group ( 9.6 % vs 7.7 % , p = 0.62 ; 28.8 % vs 23 % , p = 0.34 ) . Time to reach 100 mL/kg/day of enteral feeding ( 11.9 ± 7 vs 12.6 ± 7 days , p = 0.37 ) was not different between the groups . CONCLUSIONS Saccharomyces boulardii did not decrease the incidence of NEC or sepsis",
"Objective : To evaluate the efficacy of probiotics in the prevention of gastrointestinal colonization by C and ida species , of late-onset sepsis and neurological outcome in preterm newborns . Study Design : A prospect i ve study was conducted in 249 preterms who were subdivided into three groups : one group ( n=83 ) was supplemented with Lactobacillus ( L. ) reuteri , one group with L. rhamnosus ( n=83 ) and the other with no supplementation ( n=83 ) . The fungal colonization in the gastrointestinal tract , the late onset of sepsis and clinical parameters were recorded . A neurological structured assessment was further performed at 1 year of age . Result : C and ida stool colonization was significantly higher ( P L. reuteri group presented a significantly higher reduction in gastrointestinal symptoms than did the L. rhamnosus and control groups . Infants treated with probiotics showed a statistically significant lower incidence of abnormal neurological outcome than did the control group . Conclusion : The use of both probiotics seems to be effective in the prevention of gastrointestinal colonization by C and ida , in the protection from late-onset sepis and in reducing abnormal neurological outcomes in preterms",
"BACKGROUND AND OBJECTIVE : It has been suggested that probiotics may decrease infant mortality and nosocomial infections because of their ability to suppress colonization and translocation of bacterial pathogens in the gastrointestinal tract . We design ed a large double-blinded placebo-controlled trial using Lactobacillus reuteri to test this hypothesis in preterm infants . METHODS : Eligible infants were r and omly assigned during the first 48 hours of life to either daily probiotic administration or placebo . Infants in the intervention group were administered enterally 5 drops of a probiotic preparation containing 108 colony-forming units of L reuteri DSM 17938 until death or discharge from the NICU . RESULTS : A total of 750 infants ≤2000 g were enrolled . The frequency of the primary outcome , death , or nosocomial infection , was similar in the probiotic and placebo groups ( relative risk 0.87 ; 95 % confidence interval : 0.63–1.19 ; P = .376 ) . There was a trend toward a lower rate of nosocomial pneumonia in the probiotic group ( 2.4 % vs 5.0 % ; P = .06 ) and a nonsignificant 40 % decrease in necrotizing enterocolitis ( 2.4 % vs 4.0 % ; P = .23 ) . Episodes of feeding intolerance and duration of hospitalization were lower in infants ≤ 1500 g ( 9.6 % vs 16.8 % [ P = .04 ] ; 32.5 days vs 37 days [ P = .03 ] ) . CONCLUSIONS : Although L reuteri did not appear to decrease the rate of the composite outcome , the trends suggest a protective role consistent with what has been observed in the literature . Feeding intolerance and duration of hospitalization were decreased in premature infants ≤1500",
"Background : Nosocomial infections endanger preterm infants . Objective : The aim of the present controlled r and omized trial was to investigate whether Bifidobacterium lactis reduces the incidence of nosocomial infections in infants with very low birth weight ( VLBW ; Patients and Methods : In a r and omized controlled trial , 183 VLBW infants were stratified according to gestational age ( 23–26 and 27–29 weeks ) and early antibiotic therapy ( days 1–3 , yes or no ) and r and omly assigned to have their milk feedings supplemented with B. lactis ( 6 × 2.0 × 109 CFU/kg/day , 12 billion CFU/kg/day ) or placebo for the first 6 weeks of life . Primary outcome was the ‘ incidence density ’ of nosocomial infections defined as periods of elevated C-reactive protein ( > 10 mg/l ) from day 7 after initiation of milk feedings until the 42nd day of life ( number of nosocomial infections/total number of patient days ) . The main secondary outcome was necrotizing enterocolitis ( NEC ; ≧stage 2 ) . Results : There were 93 infants in the B. lactis group and 90 in the placebo group . There was no significant difference between the two groups with regard to the incidence density of nosocomial infections ( 0.021 vs. 0.016 ; p = 0.9 , χ2 test ) . There were 2 cases of NEC in the B. lactis group and 4 in the placebo group . None of the blood cultures grew B. lactis . Conclusion : In the present setting , B. lactis at a dosage of 6 × 2.0 × 109 CFU/kg/day ( 12 billion CFU/kg/day ) did not reduce the incidence density of nosocomial infections in VLBW infants . No adverse effect of B. lactis was observed",
"BACKGROUND AND OBJECTIVE : Late-onset sepsis frequently complicates prematurity , contributing to morbidity and mortality . Probiotics may reduce mortality and necrotizing enterocolitis ( NEC ) in preterm infants , with unclear effect on late-onset sepsis . This study aim ed to determine the effect of administering a specific combination of probiotics to very preterm infants on culture-proven late-onset sepsis . METHODS : A prospect i ve multicenter , double-blinded , placebo-controlled , r and omized trial compared daily administration of a probiotic combination ( Bifidobacterium infantis , Streptococcus thermophilus , and Bifidobacterium lactis , containing 1 × 109 total organisms ) with placebo ( maltodextrin ) in infants born before 32 completed weeks ’ gestation weighing The primary outcome was at least 1 episode of definite late-onset sepsis . RESULTS : Between October 2007 and November 2011 , 1099 very preterm infants from Australia and New Zeal and were r and omized . Rates of definite late-onset sepsis ( 16.2 % ) , NEC of Bell stage 2 or more ( 4.4 % ) , and mortality ( 5.1 % ) were low in controls , with high breast milk feeding rates ( 96.9 % ) . No significant difference in definite late-onset sepsis or all-cause mortality was found , but this probiotic combination reduced NEC of Bell stage 2 or more ( 2.0 % versus 4.4 % ; relative risk 0.46 , 95 % confidence interval 0.23 to 0.93 , P = .03 ; number needed to treat 43 , 95 % confidence interval 23 to 333 ) . CONCLUSIONS : The probiotics B infantis , S thermophilus , and B lactis significantly reduced NEC of Bell stage 2 or more in very preterm infants , but not definite late-onset sepsis or mortality . Treatment with this combination of probiotics appears to be safe",
"OBJECTIVE To determine whether routine probiotic administration to very preterm infants would reduce the incidence of necrotizing enterocolitis ( NEC ) without adverse consequences . STUDY DESIGN Since the end of July 2011 , we have administered a probiotic mixture to all admitted infants of We give 0.5 g of a mixture of 4 bifidobacteria ( Bifidobacterium breve , bifidum , infantis , and longum ) and Lactobacillus rhamnosus HA-111 [ corrected ] ( 2 × 10(9 ) colony-forming units ) per day , starting with the first feed , until the infant reaches 34 weeks . We compared complications among infants admitted during the first 17 months of routine use with those admitted during the previous 17 months . RESULTS Two hundred ninety-four infants received probiotics , and 317 infants formed the comparison group . Introduction of probiotics was associated with a reduction in NEC ( from 9.8 % to 5.4 % , P in death ( 9.8 % to 6.8 % ) , and a significant reduction in the combined outcome of death or NEC ( from 17 % to 10.5 % , P ( OR for NEC , 0.51 ; 95 % CI , 0.26 - 0.98 ; OR for death or NEC , 0.56 ; 95 % CI , 0.33 - 0.93 ) . There was no effect of probiotics on health care-associated infection . DISCUSSION A product that is readily available in North America , that has excellent quality control , and that contains strains similar to those that have been shown effective in r and omized controlled trials substantially reduced the frequency of NEC in our neonatal intensive care unit",
"Background A r and omised , double-blind clinical trial was undertaken in order to assess the effectiveness of probiotics in the prevention of necrotising enterocolitis ( NEC ) in newborns weighing Methods We studied a group of 150 patients who were r and omised in two groups after parental consent was obtained , to receive either a daily feeding supplementation with a multispecies probiotic ( Lactobacillus acidophilus , Lactobacillus rhamnosus , Lactobacillus casei , Lactobacillus plantarum , Bifidobacteruim infantis , Streptococcus thermophillus ) 1 g per day plus their regular feedings or to receive their regular feedings with nothing added ( control group ) , over the period of January 2007 through June 2010 . Clinicians in care of the infants were blinded to the group assignment . Results The primary outcome was the development of NEC . Both groups were comparable , with no differences during hospitalisation , including the type of nutrition received . Blood cultures obtained from cases that developed sepsis did not reveal lactobacillus or Bifidobacteria growth . No differences were detected in terms of NEC risk reduction ( RR : 0.54 , 95 % CI 0.21 to 1.39 ) although we did observe a clear trend in the reduction of NEC frequency in the studied cases : 6 ( 8 % ) versus 12 ( 16 % ) in the control group . When the combined risk of NEC or death was calculated as a post hoc analysis , we found a significantly lower risk ( RR : 0.39 , 95 % CI 0.17 to 0.87 ) for the study group . Conclusions Probiotics may offer potential benefits for premature infants and are a promising strategy in the reduction of the risk of NEC in preterm newborns",
"BACKGROUND Saccharomyces boulardii ( SB ) is a yeast that acts both as a probiotic and as a polyamine producer . Probiotics prevent the overgrowth of pathogens in the gut while polyamines enhance intestinal maturation . The aim of this r and omized study was to investigate the ability of SB to modify the gut microbial ecology and its function . METHODS A total of 87 healthy babies with gestational age 28 - 32 weeks were studied . They were r and omly assigned to receive a preterm formula to which SB or maltodextrins was added for 30 days . Evaluations were made on the following : SB tolerance and weight gain , faecal flora analysis , intestinal D-xylose absorption and faecal lipid excretion . RESULTS SB was well tolerated by the infants . There was no difference in weight gain between the two groups . Median log of colony forming units per gram of faeces for Escherichia coli and enterococci was significantly lower in the SB group [ E. coli : 2.67 ( 0.045 ) vs. 2.75 ( 0.058 ) , P number of bifidobacteria and staphylococci in the stools was significantly higher in the SB group [ bifidobacteria : 2.65 ( 0.083 ) vs. 2.27 ( 0.075 ) , P D-Xylose and lipid absorption was not improved by SB [ median blood D-xylose : 1.5 ( 0.4 ) mmol/l vs. 1.35 ( 0.3 ) mmol/l , P>0.1 ; median stool steatocrit : 64 % ( 3.05 % ) vs. 65 % ( 2.72 % ) P>0.5 ] . CONCLUSIONS An SB-supplemented formula is well tolerated by preterm infants , it has a beneficial effect on stool flora bringing it closer to that of breast fed babies but it does not improve D-xylose or lipid gut absorption",
"Objective To evaluate the effect of oral Lactobacillus reuteri ( L reuteri ) first on the incidence and severity of Necrotising enterocolitis ( NEC ) and second on sepsis . Design Prospect i ve r and omised controlled study . Setting Tertiary neonatal intensive care unit . Patients and interventions Preterm infants with a gestational age of ≤32 weeks and a birth weight of ≤1500 g were included ( n=400 ) . Infants in the first group were given 100 million CFU/day ( 5 drops ) of lyophilised L reuteri ( DSM 17938 ) mixed in breast milk or formula , starting from first feeding until discharge . Participants in the control group were given a placebo . Main outcome measures To determine and compare the frequency of NEC and /or death after 7 days , frequency of proven sepsis , rates of feeding intolerance and duration of hospital stay . Results There was no statistically significant difference between groups in terms of frequency of NEC stage ≥2 ( 4 % vs 5 % ; p=0.63 ) or overall NEC or mortality rates ( 10 % vs 13.5 % ; p=0.27 ) . Frequency of proven sepsis was significantly lower in the probiotic group compared to the control group ( 6.5 % vs 12.5 % ; p=0.041 ) . A significant difference was also observed with regard to rates of feeding intolerance ( 28 % vs 39.5 % ; p=0.015 ) and duration of hospital stay ( 38 ( 10–131 ) vs 46 ( 10–180 ) days ; p=0.022 ) . Conclusions Our results show that oral L reuteri does not seem to affect the overall rates of NEC and /or death in preterm infants followed up in the neonatal intensive care unit , and significant reductions were observed in the frequency of proven sepsis , rates of feeding intolerance and duration of hospital stay . Trial registration number NCT01531179",
"Background Probiotic supplementation significantly reduces the risk of necrotising enterocolitis ( NEC ) and all cause mortality in preterm neonates . Independent quality assessment is important before introducing routine probiotic supplementation in this cohort . Aim To assess product quality , and confirm that Bifidobacterium breve ( B. breve ) M-16V supplementation will increase fecal B. breve counts without adverse effects . Methods and Participants Strain identity ( 16S rRNA gene sequencing ) , viability over 2 year shelf-life were confirmed , and microbial contamination of the product was ruled out . In a controlled trial preterm neonates ( Gestation were r and omly allocated to either B. breve M-16V ( 3 × 109 cfu/day ) or placebo ( dextrin ) supplementation until the corrected age 37 weeks . Stool sample s were collected before ( S1 ) and after 3 weeks of supplementation ( S2 ) for study ing fecal B. breve levels using quantitative PCR ( Primary outcome ) . Secondary outcomes included total fecal bifidobacteria and NEC≥Stage II . Categorical and continuous outcomes were analysed using Chi-square and Mann-Whitney tests , and McNemar and Wilcoxon signed-rank tests for paired comparisons . Results A total of 159 neonates ( Probiotic : 79 , Placebo : 80 ) were enrolled . Maternal and neonatal demographic characteristics were comparable between the groups . The proportion of neonates with detectable B. breve increased significantly post intervention : Placebo : [ S1:2/66 ( 3 % ) , S2 : 25/66 ( 38 % ) , p : [ S1 : 29/74 ( 40 % ) , S2 : 67/74 ( 91 % ) , p in both groups were below detection ( There were no adverse effects including probiotic sepsis and no deaths . NEC≥Stage II occurred in only 1 neonate ( placebo group ) . Conclusion B. breve M-16V is a suitable probiotic strain for routine use in preterm neonates . Trial Registration Australia New Zeal and Clinical Trial Registry ACTRN",
"Background This study evaluated the benefit of Bifidobacterium bifidum OLB6378 ( B. bifidum ) in very low-birthweight ( VLBW ) infants ( birthweight for the acceleration of enteral feeding . Methods A cluster-r and omized , double-blind , placebo-controlled trial was conducted in 19 hospitals , divided into two groups : the B group ( n = 10 hospitals ; B. bifidum given to infants within 48 h of birth ) and the P group ( n = 9 hospitals ; infants received a placebo ) . The primary outcome was establishment of enteral feeding after birth , defined as the postnatal day at which enteral feeding exceeded 100 mL/(kg/day ) . Secondary outcomes were defined as incidence of morbidity and somatic growth before discharge . Results Overall , 283 VLBW infants were enrolled in the study : B group , n = 153 ; and P group , n = 130 . Enteral feeding was established within 21 days after birth in 233 infants , of whom 119 received B. bifidum and 114 received placebo until their bodyweight reached 2000 g. Enteral feeding was established significantly earlier in the B group , at 11.0 ± 3.6 days versus 12.1 ± 3.8days in P group ( P unit was not different between groups , but the incidence of late-onset sepsis among all enrolled infants was significantly lower in the B group ( 3.9 % , 6/153 ) than in the P group ( 10.0 % , 13/130 ; P in the incidence of other adverse outcomes including mortality . Conclusions B. bifidum in VLBW infants accelerated the establishment of enteral feeding after birth without increasing the incidence of adverse effects ",
"The objectives of this study were to determine whether or not the probiotic Lactobacillus GG can colonise the immature bowel of premature infants and if so , does colonisation result in a reduction of the size of the bowel reservoir of nosocomial pathogens such as enterobacteriaceae , enterococci , yeasts or staphylococci , and does colonisation with Lactobacillus GG have any effect on the clinical progress and outcome . Twenty preterm infants with a gestational age of 33 weeks or less who were resident on a neonatal unit were studied from the initiation of milk feeds until discharge . The infants were r and omised to receive either milk feeds or milk feeds supplemented with Lactobacillus GG 10(8 ) colony forming units twice a day for two weeks . The clinical features of the two groups of infants were similar . Orally administered Lactobacillus GG was well tolerated and did colonise the bowel of premature infants . However , colonisation with Lactobacillus GG did not reduce the faecal reservoir of potential pathogens and there was no evidence that colonisation had any positive clinical benefit for this particular group of infants",
"BACKGROUND OF THE STUDY Preterm infants are managed with antibiotics for sepsis , including suspected or probable sepsis . This leads to a delayed and abnormal colonization of the gut with potentially pathogenic organisms and a microbiome , which lacks biodiversity and increases the risk for late-onset sepsis ( LOS ) . Probiotics have been proven to reduce the risk for necrotizing enterocolitis , but evidence for prevention of LOS is inconclusive . Probiotic effect depends also on the strain used , dose and indication for use . This study evaluated Bacillus clausii probiotic administered prophylactically to preterm neonates for prevention of LOS . OBJECTIVES To study B.clausii given prophylactically to preterm neonates for prevention of LOS . DESIGN Double-blinded , placebo-controlled , r and omized trial . SETTING S Tertiary care neonatal unit in India . PARTICIPANTS Consecutive preterm neonates INTERVENTION R and omized to receive either probiotic or placebo for 6 weeks , discharge from hospital , death or occurrence of sepsis , whichever was earlier . PRIMARY OUTCOME Incidence of definite and probable LOS in probiotic group compared with placebo . RESULTS Of 326 eligible preterm infants , 244 were enrolled and 82 were excluded . Of these , 120 were stratified as extreme preterm and r and omized to receive placebo ( n = 59 ) and probiotic ( n = 61 ) . Of 124 babies stratified as very preterm , an equal number was r and omized to receive placebo ( n = 62 ) and probiotic ( n = 62 ) . There was no significant difference in the incidence of LOS between the two arms in the extreme preterm group [ 29 % vs. 23 % ; relative risk ( RR ) 1.27 ; 95 % confidence interval ( CI ) 0.88 - 1.66 ; p = 0.36 ] and the very preterm group ( 13 % vs. 10 % ; RR 1.33 ; 95 % CI 0.96 - 1.70 ; p = 0.32 ) . Full feeds were achieved significantly faster in the probiotic group in both the extreme preterm ( RR 0.82 ; 95 % CI 0.74 - 0.88 ) and the very preterm ( RR 0.67 ; 95 % 0.32 - 0.77 ) . CONCLUSIONS Prophylactic administration of B.clausii to preterm neonates did not result in a significant difference in the incidence of LOS as compared with placebo ",
"OBJECTIVE To study the efficacy and safety of probiotics for the prevention of feeding intolerance in low birth weight ( LBW ) premature infants . METHODS Sixty eligible LBW premature infants were r and omly divided into probiotics and conventional treatment groups ( n=30 each ) . Both groups received treatment of the primary disease . Additionally , the probiotics treatment group was administered with probiotics ( 0.25 g , twice daily ) . The incidence of feeding intolerance , the time to regain birth weight and to reach full enteral nutrition and the length of hospitalization were compared between the two groups . The occurrence of adverse reactions was recorded . RESULTS The incidence of feeding intolerance in the probiotics treatment group was lower than that in the conventional treatment group ( 4 % vs 14 % ; P The time to regain birth weight ( 6.8±1.2 days vs 7.7±1.6 days ; P the time to reach full enteral nutrition ( 8.0±1.4 days vs 9.0±2.0 days ; P . No adverse reactions were observed in the probiotics treatment group . CONCLUSIONS Probiotics can reduce the incidence of feeding intolerance in LBW premature infants , can promote weight gain and shorten the time to reach full enteral nutrition . The application of probiotics appears to be safe in LBW premature infants",
"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",
"BACKGROUND Preterm infants have increased intestinal permeability which can render them susceptible to infections from enterobacteriae . OBJECTIVES The primary objective was to investigate whether probiotic administration to preterm infants decreases intestinal permeability . Secondary outcomes studied were : somatic growth , tolerance , rates of sepsis and necrotizing enterocolitis . METHODS In a prospect i ve r and omized case-control study 41 stable preterm infants of 27 to 36 weeks gestation and 34 matched comparison infants consecutively admitted to the neonatal unit were studied . The study group received a preterm formula supplemented with Bifidobacter lactis ( 2 x 10(7 ) cfu/g of dry milk ) while the control group received the same formula but without supplementation . Intestinal permeability was measured within two days of birth and then seven and thirty days later using the sugar absorption test . Additionally anthropometric parameters were recorded throughout the study as well as acceptance and tolerance of the formula . RESULTS All infants tolerated the study formula well . Median counts of stool bifidobacteria and lactulose/mannitol ratios at baseline were comparable . After 7 days of supplementation median bifidobacteria counts were significantly higher in the study group than in the control group ( p=0.0356 ) and they remained higher to the end of the study ( p at day 30=0.075 ) . The L/M ratio in the study group was significantly lower at day 30 of the study as compared to the control group ( p=0.003 ) . Head growth was significantly higher in the study group ( p=0.001 ) . CONCLUSIONS The administration of a bifidobacter supplemented infant formula decreases intestinal permeability of preterm infants and leads to increased head growth",
"OBJECTIVE To study the possible roles of probiotics in decreasing intestinal bacterial colonization rate and the incidence of enterogenic infections in premature infants . METHODS Seventy premature infants were r and omly assigned to two groups : probiotics and conventional treatment groups ( control ) ( n=35 each ) . The probiotics treatment group was administered with oral Clostridium butyricum powder ( 250 mg , twice daily up to discharge ) 24 hrs after birth except conventional treatment . Rectal swab cultures were done at admission , 5 and 12 days after admission , and before discharge . Clinical and laboratory findings were compared between the two groups . RESULTS The intestinal bacterial colonization rate in the probiotics treatment group was lower than that in the control group 12 days after admission ( 60 % vs 83 % ; p Klebsiella pneumoniae , Escherichia coli and Enterococcus faecium were common colonization bacteria in the two groups . Diarrhea occurred in 7 cases ( 20 % ) in the probiotics treatment group compared with 16 cases ( 46 % ) in the control group ( p sepsis in the probiotics treatment group compared with 9 cases ( 26 % ) in the control group ( p intestinal bacterial colonization rate and the incidence of diarrhea and sepsis in premature infants",
"OBJECTIVE To evaluate the effect of oral administration of probiotics on intestinal colonization with drug-resistant bacteria among preterm infants in the neonatal intensive care unit ( NICU ) . METHODS A double-blind , r and omized , placebo-controlled trial was carried out in the preterm infants who were transferred to the NICU immediately after birth . These infants were stratified by whether they were breastfed and then r and omized into test group and control group . The test group was given probiotics from the day when enteral feeding began , while the control group was treated conventionally without probiotics . The two groups were compared in terms of the colonization with extended-spectrum beta-lactamase-producing bacteria , as assessed by rectal swabs on days 1 , 3 , 7 , and 14 after birth , and the incidence of diseases . RESULTS Rectal colonization with drug-resistant bacteria was found in the test group ( n=119 ) and control group ( n=138 ) on days 1 , 3 , 7 , and 14 after birth . There were no significant differences in the incidence of late-onset sepsis and necrotizing enterocolitis between the two groups ( P>0.05 ) . Among non-breastfed infants , the test group had significantly decreased rectal colonization with drug-resistant bacteria compared with the control group on day 14 after birth ( 71.1 % vs 88.9 % ; P=0.04 ) . No probiotic-related adverse events were observed in the study . CONCLUSIONS Oral administration of probiotics may reduce rectal colonization with drug-resistant bacteria in preterm infants under certain conditions and shows good safety",
"OBJECTIVE To evaluate the impact of early prebiotic and probiotic intervention on preterm infants ' well-being , crying , growth , and microbiological programming . STUDY DESIGN Ninety-four preterm infants ( gestational age 32 - 36 weeks and birth weight > 1500 g ) r and omized to receive prebiotics ( mixture of galacto-oligosaccharide and polydextrose 1:1 ) , probiotics ( Lactobacillus rhamnosus GG ) , or placebo during the first 2 months of life were followed up for 1 year . Infants were categorized based on the extent of crying and irritability during the first 2 months of life , and their gut microbiota was investigated by fluorescence in situ hybridization ( n = 66 ) and quantitative polymerase chain reaction ( n = 63 ) . RESULTS A total of 27 of 94 infants ( 29 % ) infants were classified as excessive criers , significantly less frequently in the prebiotic and the probiotic groups than in the placebo group ( 19 % vs 19 % vs 47 % , respectively ; P = .02 ) . The placebo group had a higher percentage of Clostridium histolyticum group bacteria in their stools than did the probiotic group ( 13.9 % vs 8.9 % , respectively ; P = .05 ) . There were no adverse events related to either supplementation . CONCLUSIONS Early prebiotic and probiotic supplementation may alleviate symptoms associated with crying and fussing in preterm infants . This original finding may offer new therapeutic and preventive measures for this common disturbance in early life",
"Background : It has been suggested that probiotics can reduce the overgrowth of pathogens in the bowels of preterm infants and contribute to the reduction of the incidence of nosocomial infections in neonatal intensive care units ( NICUs ) . The purpose of this study was to evaluate the effectiveness of Lactobacillus GG supplementation in reducing the incidence of urinary tract infections ( UTIs ) , bacterial sepsis and necrotizing enterocolitis ( NEC ) in preterm infants . Methods : A double-blind study was conducted in 12 Italian NICUs . Newborn infants with a gestational age were r and omized to receive st and ard milk feed supplemented with Lactobacillus GG ( Dicoflor ® , Dicofarm , Rome , Italy ) in a dose of 6 × 109 colony-forming units ( cfu ) once a day until discharge , starting with the first feed or placebo . Results : Five hundred eighty-five patients were studied . The probiotics group ( n = 295 ) and the placebo group ( n = 290 ) exhibited similar clinical characteristics . The duration of Lactobacillus GG and placebo supplementation was 47.3 ± 26.0 and 48.2 ± 24.3 days , respectively . Although UTIs ( 3.4 vs. 5.8 % ) and NEC ( 1.4 vs. 2.7 % ) were found less frequently in the probiotic group compared to the control group , these differences were not significant . Bacterial sepsis was more frequent in the probiotics group ( 4.4 % , n = 11 ) than in the placebo group ( 3.8 % , n = 9 ) , but the difference was not significant . Conclusion : Seven days of Lactobacillus GG supplementation starting with the first feed is not effective in reducing the incidence of UTIs , NEC and sepsis in preterm infants . Further studies are required to confirm our results in lower birthweight population",
"Objective : The objective of this trial was to test whether probiotic-supplemented feeding to extremely low-birth-weight ( ELBW ) infants will improve growth as determined by decreasing the percentage of infants with weight below the 10th percentile at 34 weeks postmenstrual age ( PMA ) . Other important outcome measures , such as improving feeding tolerance determined by tolerating larger volume of feeding per day and reducing antimicrobial treatment days during the first 28 days from the initiation of feeding supplementation were also evaluated . Study Design : We conducted a multicenter r and omized controlled double-blinded clinical study . The probiotics-supplementation ( PS ) group received Lactobacillus rhamnosus GG and Bifidobacterium infantis added to the first enteral feeding and continued once daily with feedings thereafter until discharge or until 34 weeks ( PMA ) . The control ( C ) group received unsupplemented feedings . Infant weight and feeding volumes were recorded daily during the first 28 days of study period . Weights were also recorded at 34 weeks PMA . Result : A total of 101 infants were enrolled ( PS 50 versus C 51 ) . There was no difference between the two groups in the percentage of infants with weight below the 10th percentile at 34 weeks PMA ( PS group 58 % versus C group 60 % , ( P value 0.83 ) ) or in the average volume of feeding during 28 days after study entry ( PS group 59 ml kg−1 versus C group 71 ml kg−1 , ( P value 0.11 ) ) . Calculated growth velocity was higher in the PS group compared with the C group ( 14.9 versus 12.6 g per day , ( P value 0.05 ) ) . Incidences of necrotizing enterocolitis ( NEC ) , as well as mortality were similar between the two groups . Conclusion : Although probiotic-supplemented feedings improve growth velocity in ELBW infants , there was no improvement in the percentage of infants with growth delay at 34 weeks PMA . There were no probiotic-related adverse events reported",
"BACKGROUND Colonization by C and ida species is the most important predictor of the development of invasive fungal disease in preterm neonates , and the enteric reservoir is a major site of colonization . We evaluated the effectiveness of an orally supplemented probiotic ( Lactobacillus casei subspecies rhamnosus ; Dicoflor [ Dicofarm spa ] ; 6 x 10(9 ) cfu/day ) in the prevention of gastrointestinal colonization by C and ida species in preterm , very low birth weight ( i.e. , METHODS Over a 12-month period , a prospect i ve , r and omized , blind , clinical trial that involved 80 preterm neonates with a very low birth weight was conducted in a large tertiary neonatal intensive care unit . During the first 3 days of life , the neonates were r and omly assigned to receive either an oral probiotic added to human ( maternal or pooled donors ' ) milk ( group A ) or human milk alone ( group B ) for 6 weeks or until discharge from the NICU , if the neonate was discharged before 6 weeks . On a weekly basis , specimens obtained from various sites ( i.e. , oropharyngeal , stool , gastric aspirate , and rectal specimens ) were collected from all patients for surveillance culture , to assess the occurrence and intensity of fungal colonization in the gastrointestinal tract . RESULTS The incidence of fungal enteric colonization ( with colonization defined as at least 1 positive culture result for specimens obtained from at least 1 site ) was significantly lower in group A than in group B ( 23.1 % vs. 48.8 % ; relative risk , 0.315 [ 95 % confidence interval , 0.120 - 0.826 ] ; P = .01 ) . The numbers of fungal isolates obtained from each neonate ( P = .005 ) and from each colonized patient ( P = .005 ) were also lower in group A than in group B. L. casei subspecies rhamnosus was more effective in the subgroup of neonates with a birth weight of 1001 - 1500 g. There were no changes in the relative proportions of the different C and ida strains . No adverse effects potentially associated with the probiotic were recorded . CONCLUSIONS Orally administered L. casei subspecies rhamnosus significantly reduces the incidence and the intensity of enteric colonization by C and ida species among very low birth weight neonates",
"OBJECTIVES To evaluate data for the period 2004 - 2013 to identify changes in demographics , pathogens , and outcomes in a single , level IV neonatal intensive care unit . STUDY DESIGN Sepsis episodes were identified prospect ively and additional information obtained retrospectively from infants with sepsis while in the neonatal intensive care unit from 2004 to 2013 . Demographics , hospital course , and outcome data were collected and analyzed . Sepsis was categorized as early ( ≤3 days of life ) or late-onset ( > 3 days of life ) . RESULTS Four hundred fifty-two organisms were identified from 410 episodes of sepsis in 340 infants . Ninety percent of cases were late-onset . Rates of early-onset sepsis remained relatively static throughout the study period ( 0.9 per 1000 live births ) . For the first time in decades , most ( 60 % ) infants with early-onset sepsis were very low birth weight and Escherichia coli ( 45 % ) replaced group B streptococcus ( 36 % ) as the most common organism associated with early-onset sepsis . Rates of late-onset sepsis , particularly due to coagulase-negative staphylococci , decreased significantly after implementation of several infection-prevention initiatives . Coagulase-negative staphylococci were responsible for 31 % of all cases from 2004 to 2009 but accounted for no cases of late-onset sepsis after 2011 . CONCLUSIONS The epidemiology and microbiology of early- and late-onset sepsis continue to change , impacted by targeted infection prevention efforts . We believe the decrease in sepsis indicates that these interventions have been successful , but additional surveillance and strategies based on evolving trends are necessary",
"Background / Objective : The identification of probiotic species involved in gut homeostasis and their potential therapeutic benefits have led to an interest in their use for preventing necrotizing enterocolitis ( NEC ) . Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials . Lactobacillus sporogenes has not been used in the prevention of NEC in very low-birth weight infants yet . The objective of this study was to evaluate the efficacy of orally administered L sporogenes in reducing the incidence and severity of NEC in very low-birth weight ( VLBW ) infants . Subjects/ Methods : A prospect i ve , blinded , r and omized controlled trial was conducted in preterm infants with a gestational age of The infants in the study group were given L. sporogenes with a dose of 350 000 000 c.f.u . added to breast milk or formula , once a day , starting with the first feed until discharged . The infants in the control group were fed without L. sporogenes supplementation . The primary outcome measurement was death or NEC ( Bell 's stage ⩾2 ) . Results : A total of 221 infants were studied : 110 in the study group and 111 in the control group . There was no significant difference in the incidence of death or NEC between the groups . Feeding intolerance was significantly lower in the probiotics group than in the control group ( 44.5 % ( n : 49 ) vs 63.1 % ( n : 70 ) , respectively ; P=0.006 ) . Conclusions : L. sporogenes supplementation at the dose of 350 000 000 c.f.u/day is not effective in reducing the incidence of death or NEC in VLBW infants , however , it could improve the feeding tolerance ",
"OBJECTIVE To test the efficacy of probiotic and prebiotic , alone or combined ( synbiotic ) , on the prevention of necrotizing enterocolitis ( NEC ) in very low birth weight ( VLBW ) infants . STUDY DESIGN A prospect i ve , r and omized , controlled trial was conducted at 5 neonatal intensive care units in Turkey . VLBW infants ( n = 400 ) were assigned to a control group and 3 study groups that were given probiotic ( Bifidobacterium lactis ) , prebiotic ( inulin ) , or synbiotic ( Bifidobacterium lactis plus inulin ) added to breastmilk or formula for a maximum of 8 weeks before discharge or death . The primary outcome was NEC ( Bell stage ≥2 ) . RESULTS The rate of NEC was lower in probiotic ( 2.0 % ) and synbiotic ( 4.0 % ) groups compared with prebiotic ( 12.0 % ) and placebo ( 18.0 % ) groups ( P The times to reach full enteral feeding were faster ( P the rates of clinical nosocomial sepsis were lower ( P = .004 ) , stays in the neonatal intensive care unit were shorter , ( P = .002 ) , and mortality rates were lower ( P = .003 ) for infants receiving probiotics , prebiotics , or synbiotic than controls . The use of antenatal steroid ( OR 0.5 , 95 % CI 0.3 - 0.9 ) and postnatal probiotic ( alone or in synbiotic ) ( OR 0.5 , 95 % CI 0.2 - 0.8 ) decreased the risk of NEC , and maternal antibiotic exposure increased this risk ( OR 1.9 , 95 % CI 1.1 - 3.6 ) . CONCLUSIONS In VLBW infants , probiotic ( Bifidobacterium lactis ) and synbiotic ( Bifidobacterium lactis plus inulin ) but not prebiotic ( inulin ) alone decrease NEC",
"BACKGROUND Late-onset sepsis is a relatively common complication particularly of preterm birth that affects approximately a quarter of very low birth weight infants . AIM We aim ed to determine the motor , cognitive , and behavioural outcome at school age of preterm children with late-onset sepsis compared to matched controls . STUDY DESIGN AND SUBJECTS A prospect i ve case-control study that included preterm infants ( gestational age OUTCOME MEASURES At school age we assessed motor skills , intelligence , visual perception , visuomotor integration , verbal memory , attention , executive functioning , and behaviour . RESULTS At 6 - 9years , 21 of 32 children with late-onset sepsis ( 68 % ) had borderline or abnormal motor outcome with most problems in fine motor skills . Their total IQ was 89 compared to 98 in controls . In addition , verbal memory and attention were affected compared to controls ( 0.61 st and ard deviations ( SD ) , 95 % confidence interval ( CI ) 0.04 - 1.17 , p=0.033 and 0.94 SD , 95 % CI 0.32 - 1.62 , p=0.011 , respectively ) . Multiple episodes of sepsis and gram-negative sepsis were risk factors for worse cognitive outcome . CONCLUSIONS At school age , a majority of preterm children with late-onset sepsis had motor problems . Their IQ was considerably lower than matched controls , and memory and attention were specifically impaired . Outcome at school age of preterm children with late-onset sepsis was worse than previously thought",
"BACKGROUND Although recent reports suggest that supplementation with probiotics may enhance intestinal function in premature infants , the mechanisms are unclear , and questions remain regarding the safety and efficacy of probiotics in extremely low-birth-weight infants . OBJECTIVE The objective was to evaluate the efficacy of probiotics on the digestive tolerance to enteral feeding in preterm infants born with a very low or extremely low birth weight . DESIGN In a bicentric , double-blind , r and omized controlled clinical trial that was stratified for center and birth weight , 45 infants received enteral probiotics ( Bifidobacterium longum BB536 and Lactobacillus rhamnosus GG ; BB536-LGG ) and 49 received placebo . The primary endpoint was the percentage of infants receiving > 50 % of their nutritional needs via enteral feeding on the 14th day of life . A triangular test was used to perform sequential analysis . RESULTS The trial was discontinued after the fourth sequential analysis concluded a lack of effect . The primary endpoint was not significantly different between the probiotic ( 57.8 % ) and placebo ( 57.1 % ) groups ( P = 0.95 ) . However , in infants who weighed > 1000 g , probiotic supplementation was associated with a shortening in the time to reach full enteral feeding ( P = 0.04 ) . Other than colonization by the probiotic strains , no alteration in the composition of intestinal microbiota or changes in the fecal excretion of calprotectin was observed . No colonization by probiotic strains was detected in infants who weighed gastrointestinal tolerance to enteral feeding in very-low-birth-weight infants but may improve gastrointestinal tolerance in infants weighing > 1000 g. This trial was registered at clinical trials.gov as NCT 00290576",
"AIM To investigate the colonisation withBifidobacterium breve of the bowels of very low birthweight ( VLBW ) infants . METHODS The adverse effects of B breve were examined in 66 VLBW infants ( preliminary study ) . A prospect i ve r and omised clinical study of 91 VLBW infants was also completed and these infants were followed up for three years . Precise viable bacterial counts of serial stool specimens were examined for the first eight weeks after birth in 10 infants . The colonisation rates of administered bacteria were examined using immunohistochemical staining of stool specimens with a B breve specific monoclonal antibody . RESULTS In the preliminary study there were no side effects attributable to the bacteria . Immunohistochemical staining of stool specimens showed that the colonisation rates of the administered bacteria were 73 % at 2 weeks of age , but only 12 % in the control group . Early administration of B brevesignificantly decreased aspirated air volume from the stomach and improved weight gain . CONCLUSIONS B breve can colonise the immature bowel very effectively and is associated with fewer abnormal abdominal signs and better weight gain in VLBW infants , probably as a result of stabilisation of their intestinal flora and accelerated feeding schedules",
"OBJECTIVE To compare the effectiveness of two antibiotic regimens among neonates with late onset sepsis ( LOS ) . METHODS This r and omized controlled trial conducted in a tertiary care teaching hospital , South India , included 90 babies with LOS . Detailed history , examination and appropriate investigations were done for all the babies . Cloxacillin + Amikacin were administered to 40 and Cefotaxime + Gentamicin to 50 babies . Outcomes including mortality , complications and treatment failure were evaluated . Chi-square test was used for categorical variables and Student 's unpaired t-test for continuous variables . RESULTS LOS had a male preponderance , and median time of onset was 13 days . Mortality was more among low birth weight babies irrespective of the antibiotics . Predominant bacteria isolated were coagulase-negative staphylococci ( 26.67 % ) , Escherichia coli ( 13.33 % ) and Streptococcus pneumoniae ( 13.33 % ) . Complications , mortality and cost were similar in both regimens . CONCLUSION There was no significant difference between the two antibiotic regimens with regard to outcome of LOS",
"Objective : The objective of this study is to determine the prevalence , causes and outcome of sepsis in hospitalized neonates in the largest neonatal unit in central Vietnam . Study Design : A 1-year prospect i ve cohort study of newborns admitted to the neonatal unit in Da Nang . A sepsis work-up including blood culture was undertaken before commencing antibiotics for neonates with suspected sepsis . Result : Of 2555 neonatal admissions , 616 neonates had 729 episodes of suspected invasive sepsis . A pathogen was isolated from blood in 115 ( 16 % ) episodes in 106 neonates . The prevalence of early-onset sepsis ( EOS ) was 8 ( 95 % confidence interval ( CI ) : 4 to 11 ) per 1000 admissions , and of late-onset sepsis ( LOS ) was 34 ( 95 % CI : 27 to 41 ) per 1000 admissions . Of 86 neonates with LOS , 69 ( 80 % ) also fulfilled the criteria for nosocomial sepsis . The commonest bacterial causes of EOS were coagulase-negative Staphylococcus ( CoNS ) and Staphylococcus aureus , and of LOS were Acinetobacter , CoNS and Klebsiella pneumoniae . Fungal sepsis occurred in 35 neonates of which most were nosocomial sepsis . In vitro resistance to multiple antibiotics was common among Gram-negative bacteria . Antibiotics were prescribed and given to 68 % of all admissions , and 14 % of all admissions received four or more different antibiotics . The case fatality rate for confirmed sepsis was 46 % . Conclusion : Late-onset , nosocomial sepsis was common and associated with a high mortality in hospitalized newborns in the largest neonatal unit in central Vietnam . These findings highlighted the need for improved infection control measures and antibiotic stewardship , which have since been implemented",
"BACKGROUND Necrotizing enterocolitis ( NEC ) is the most serious gastrointestinal problem in very low birth weight preterm infants . Multiple risk factors activate the inflammatory cascade leading to high expressions of pro-inflammatory mediators causing bowel injury in NEC . The anti-inflammatory effect of probiotics is due to the inhibition and reduction of inflammatory signal in intestinal epithelium . OBJECTIVE To evaluate the efficacy of probiotics supplementation in the prevention of NEC among very low birth weight preterm infants . STUDY DESIGN A prospect i ve r and omized controlled trial . MATERIAL AND METHOD All preterm infants with gestational age less than or equal to 34 weeks and birth weight less than or equal to 1,500 grams admitted in neonatal care unit , Queen Sirikit National Institute of Child Health during June 1st , 2012 and January 31th , 2013 were enrolled in this study . They were r and omized into two groups , study and control group . Infants in the study group were fed Infloran ( Lactobacillus acidophilus 1 x 10(9 ) and Bifidobacterium bifidum 1 x 10(9 ) organisms ) dose 125 mg/kg/dose twice a day with breast milk or premature formula from the start of feeding until 6 weeks or discharge . Infants in the control group were fed with either breast milk or premature formula alone . The primary outcome was NEC stage ≥ 2 . RESULTS Sixty infants completed the study , 31 infants in the study group and 29 infants in the control group . The baseline characteristic data of infants were similar except for more males in the present study group . Incidence of NEC stage ≥ 2 were similar in both the groups , 3.2 vs. 3.4 % ( p = 0.74 ) . There were no deaths during the study period . Days to reach full feeding , 150 ml/kg/day , were no differences between the two groups , 12.03 ± 5.49 days vs. 13.76 ± 8.25 days ( p = 0.31 ) . No adverse effects such as sepsis , flatulence or diarrhea were noted . CONCLUSION In this study , there was no difference in incidence of NEC stage ≥ 2 between the two groups . No adverse effects of probiotics supplementation were observed",
"OBJECTIVE To compare stool colonization among premature infants receiving high-dose probiotics versus st and ard dose . STUDY DESIGN This blinded , r and omized , placebo-controlled trial was conducted in a Level III neonatal unit . Eligibility criteria were gestational age 27 - 33 weeks , age malformations and necrotizing enterocolitis/sepsis were exclusions . A total of 149 subjects were r and omly allocated to groups A through D ( received 12-hourly probiotic supplements of 10(10 ) cells for 21 days , 10(10 ) cells for 14 days , 10(9 ) cells for 21 days and placebo , respectively ) . Key outcome was stool colonization by a probiotic organism at 28 days . RESULTS Colonization with Lactobacillus and Bifidobacterium was significantly higher in groups A , B , and C versus placebo respectively , but groups A through C did not differ from each other . There were trends toward more colony forming unit ( cfu ) of Lactobacillus and Bifidobacterium per milliliter of stool in group A versus B and B versus C. Groups A and B and spontaneous preterm labor ( SPL ) independently predicted high Lactobacillus counts on day 28 ; groups A , B , and C and SPL predicted high Bifidobacterium counts . CONCLUSION Proportion of infants colonized with probiotic species was similar with high-dose and st and ard dose regimes",
"Objective Neonatal sepsis is a major cause of neonatal deaths in Asia but data remain scarce . We aim ed to investigate the causative organisms and antibiotic resistance in neonatal care units in China , Malaysia , Hong Kong and Thail and . Methods Prospect i ve cohort study of neonatal sepsis defined as positive culture of a single potentially pathogenic organism from blood or cerebrospinal fluid differentiated into early-onset sepsis ( EOS ) occurring days of birth and late-onset sepsis ( LOS ) ≥3 days after birth . Results During the study period , there were 963 episodes of neonatal sepsis . The incidence of EOS was 0.62 ( 95 % CI 0.45 to 0.82 ) per 1000 live births or 4.91 ( 95 % CI 4.22 to 5.68 ) per 1000 admissions while the incidence of LOS was 5.00 ( 95 % CI 4.51 to 5.53 ) per 1000 live births or 21.22 ( 95 % CI 19.79 to 22.77 ) per 1000 admissions . The incidence of Group B Streptococcus ( GBS ) sepsis was low but remained the most common single pathogen for EOS among inborn babies . Klebsiella spp . was the most common Gram-negative organism causing most deaths . The case-fatality was 7.0 % ( 95 % CI 3.9 % to 12.0 % ) for EOS and 16.0 % ( 95 % CI 13.7 % to 19.0 % ) for LOS , and was significantly different between participating units after adjusting for potential confounders . Of all Gram-negative organisms , 47 % , 37 % and 32 % were resistant to third-generation cephalosporins , gentamicin or both , respectively . Conclusions The pattern of EOS in Asian setting s is similar to that in industrialised countries with low incidence of GBS sepsis . The important features of neonatal sepsis in Asia are the burden of Klebsiella spp . and high level of antibiotic resistance . These should be addressed while developing measures to reduce neonatal mortality due to infection",
"To assess the impact of a h and hygiene protocol , using h and washing , alcohol h and rub and gloves when caring for preterm infants born after 31 weeks of gestation , on the incidence of neonatal late onset sepsis ( LOS )"
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BACKGROUND Vasomotor symptoms , such as hot flushes and night sweats , are very common during the menopausal transition . Hormone therapy has traditionally been used as a highly effective treatment , but concerns about increased risk of some chronic diseases have markedly increased the interest of women in alternative treatments . Some of the most popular of these treatments are foods or supplements enriched with phytoestrogens-plant-derived chemicals that have estrogenic action . OBJECTIVES To assess the efficacy , safety and acceptability of food products , extracts and dietary supplements containing high levels of phytoestrogens when compared with no treatment , placebo or hormone therapy for the amelioration of vasomotor menopausal symptoms ( such as hot flushes and night sweats ) in perimenopausal and postmenopausal women . SEARCH METHODS Search es targeted the following electronic data bases : the Cochrane Menstrual Disorders and Subfertility Group Specialised Register of r and omised trials ( 29 July 2013 ) , the Cochrane Register of Controlled Trials ( CENTRAL ; 29 July 2013 ) , MEDLINE ( inception to 29 July 2013 ) , EMBASE ( inception to 29 July 2013 ) , AMED ( 1985 to 29 July 2013 ) , PsycINFO ( inception to 29 July 2013 ) and CINAHL ( inception to 29 July 2013 ) . Attempts were made to access grey literature by sending letters to pharmaceutical companies and performing search es of ongoing trial registers . Reference lists of included trials were also search ed . SELECTION CRITERIA Studies were included if they were r and omised , included perimenopausal or postmenopausal participants with vasomotor symptoms ( hot flushes or night sweats ) , lasted at least 12 weeks and provided interventions such as foods or supplements with high levels of phytoestrogens ( not combined with other herbal treatments ) . Trials that included women who had breast cancer or a history of breast cancer were excluded . DATA COLLECTION AND ANALYSIS Selection of trials , extraction of data and assessment of quality were undertaken by at least two review authors . Most trials were too dissimilar for their results to be combined in a meta- analysis , so these findings are provided in narrative ' Summary of results ' tables . Studies were grouped into broad categories : dietary soy , soy extracts , red clover extracts , genistein extracts and other types of phytoestrogens . Five trials used Promensil , a red clover extract ; results of these trials were combined in a meta- analysis , and summary effect measures were calculated . MAIN RESULTS A total of 43 r and omised controlled trials ( 4,364 participants ) were included in this review . Very few trials provided data suitable for inclusion in a meta- analysis . Among the five trials that yielded data assessing the daily frequency of hot flushes suitable for pooling , no significant difference overall was noted in the incidence of hot flushes between participants taking Promensil ( a red clover extract ) and those given placebo ( mean difference ( MD ) -0.93 , 95 % confidence interval ( CI ) -1.95 to 0.10 , I(2 ) = 31 % ) . No evidence indicated a difference in percentage reduction in hot flushes in two trials between Promensil and placebo ( MD 20.15 , 95 % CI -12.08 to 52.38 , I(2 ) = 82 % ) . Four trials that were not combined in meta-analyses suggested that extracts with high ( > 30 mg/d ) levels of genistein consistently reduced the frequency of hot flushes . Individual results from the remaining trials were compared in broad subgroups such as dietary soy , soy extracts and other types of phytoestrogens that could not be combined . Some of these trials found that phytoestrogen treatments alleviated the frequency and severity of hot flushes and night sweats when compared with placebo , but many trials were small and were determined to be at high risk of bias . A strong placebo effect was noted in most trials , with a reduction in frequency ranging from 1 % to 59 % with placebo . No indication suggested that discrepant results were due to the amount of isoflavone in the active treatment arm , the severity of vasomotor symptoms or trial quality factors . Also , no evidence indicated that these treatments caused oestrogenic stimulation of the endometrium or the vagina or other adverse effects when used for up to two years . AUTHORS ' CONCLUSIONS No conclusive evidence shows that phytoestrogen supplements effectively reduce the frequency or severity of hot flushes and night sweats in perimenopausal or postmenopausal women , although benefits derived from concentrates of genistein should be further investigated
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"The aim of this study was to test the hypothesis that increased dietary intake of phytoestrogens reduces the health impact of the menopause . To test this hypothesis , a double-blind , r and omized , entry-exit , cross-over study was conducted to assess the effects of three dietary manipulations -- soy and linseed diets ( high in phytoestrogens ) and a wheat diet ( low in phytoestrogens ) . Postmenopausal women were recruited and r and omly assigned to one of the three dietary regimens . Urinary phytoestrogen concentrations , hot flush rate , vaginal smears , bone mineral density and bone mineral content were assessed for two 12-week periods . Comparative analysis showed no significant differences , but , when analyzed separately , groups consuming high phytoestrogen diets had between 10 and 30 times higher urinary excretion of phytoestrogens compared to those consuming the low phytoestrogen diet ( p Study participants consuming soy , linseed and wheat diets had a 22 % ( not significant , n.s . ) , 41 % ( p hot flush rate ; a 103 % ( p vaginal cytology maturation index ; and a 5.2 % ( p bone mineral content , respectively . No changes were detected in bone mineral density . The differential effects of high phytoestrogen dietary manipulations on outcomes may represent tissue-specific responses to isoflavones and lignans contained in soy and linseed , respectively . Whilst health outcome measures were not significantly different between groups , the data obtained from separate analysis suggest that phytoestrogens in soy and linseed may be of use in ameliorating some of the symptoms of menopause . Furthermore , the significant decrease in hot flush rate in the wheat group can not be attributable to phytoestrogens measured in this study . Due to subject variability , larger studies are still needed to evaluate population benefit",
"BACKGROUND Concerns regarding the risk of estrogen replacement have result ed in a significant increase in the use of soy products by menopausal women who , despite the lack of evidence of the efficacy of such products , seek alternatives to menopausal hormone therapy . Our goal was to determine the efficacy of soy isoflavone tablets in preventing bone loss and menopausal symptoms . METHODS The study design was a single-center , r and omized , placebo-controlled , double-blind clinical trial conducted from July 1 , 2004 , through March 31 , 2009 . Women aged 45 to 60 years within 5 years of menopause and with a bone mineral density T score of -2.0 or higher in the lumbar spine or total hip were r and omly assigned , in equal proportions , to receive daily soy isoflavone tablets , 200 mg , or placebo . The primary outcome was changes in bone mineral density in the lumbar spine , total hip , and femoral neck at the 2-year follow-up . Secondary outcomes included changes in menopausal symptoms , vaginal cytologic characteristics , N -telopeptide of type I bone collagen , lipids , and thyroid function . RESULTS After 2 years , no significant differences were found between the participants receiving soy tablets ( n = 122 ) and those receiving placebo ( n = 126 ) regarding changes in bone mineral density in the spine ( -2.0 % and -2.3 % , respectively ) , the total hip ( -1.2 % and -1.4 % , respectively ) , or the femoral neck ( -2.2 % and -2.1 % , respectively ) . A significantly larger proportion of participants in the soy group experienced hot flashes and constipation compared with the control group . No significant differences were found between groups in other outcomes . CONCLUSIONS In this population , the daily administration of tablets containing 200 mg of soy isoflavones for 2 years did not prevent bone loss or menopausal symptoms . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00076050",
"OBJECTIVE To evaluate the efficacy comparison of Pueraria mirifica ( PM ) , name in Thai is Kwao Kruea Khao , against conjugated equine estrogen ( CEE ) with/without medroxyprogesterone acetate ( MPA ) in the treatment of perimenopuasal women with climacteric symptoms . MATERIAL AND METHOD Perimenopausal women attending the Menopausal clinic of Hat Yai Regional Hospital were voluntarily recruited . The vasomotor symptoms such as hot flushes and night sweats , as well as other unpleasant symptoms , urogenital and psychological symptoms , were also assessed . Patients were voluntarily enrolled and r and omly received daily 50 mg raw material of PM , Group A , or daily 0.625 mg of conjugated equine estrogen ( CEE ) with/without 2.5 mg of medroxyprogesterone acetate ( MPA ) , Group B , depend on non-hysterectomized/hysterectomized condition . RESULTS Seventy-one patients were enrolled . Eleven of those were excluded for failing to complete the initial work-up and follow-up . Sixty cases were evaluated , 30 cases in Group A and 30 cases in Group B. After medication , the mean of modified Greene climacteric scale ( MGCS ) in Group A/Group B had decreased from 29.0/32.26 to 17.86/18.1 , 12.56/9.57 and 9.9/8.16 at 1- , 3- , and 6- month respectively . The clinical satisfaction using MGCS was not statistically significant between PM ( Group A ) and CEE with/without MPA ( Group B ) in the alleviation of climacteric symptoms ( p-value > 0.05 ) . There were no statistically significant changes of three serum markers : estradiol , follicle-stimulating hormone ( FSH ) , and luteinizing hormone ( LH ) between both groups . CONCLUSION PM , containing phytoestrogens , has estrogenic effect as similar as CEE , and can alleviate the climacteric symptoms in perimenopausal women . PM demonstrates great promise in the treatment of climacteric symptoms . However , optimal doses should be clinical ly assessed to meet appropriate individual responses",
"CONTEXT The effects of continuous combined hormone therapy on gynecologic cancers have not been investigated previously in a r and omized trial setting . OBJECTIVE To determine the possible associations of estrogen plus progestin on gynecologic cancers and related diagnostic procedures . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial of 16 608 postmenopausal women , who had not had a hysterectomy at baseline and who had been recruited from 40 US clinical centers between September 1993 and October 1998 ( average follow-up , 5.6 years ) . INTERVENTION One tablet per day containing 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate ( n = 8506 ) or placebo ( n = 8102 ) . MAIN OUTCOME MEASURE Incident invasive cancer of the ovary and endometrium . RESULTS In 5.6 years of follow-up , there were 32 cases of invasive ovarian cancer , 58 cases of endometrial cancer , 1 case of nonendometrial uterine cancer , 13 cases of cervical cancer , and 7 cases of other gynecologic cancers . The hazard ratio ( HR ) for invasive ovarian cancer in women assigned to estrogen plus progestin compared with placebo was 1.58 ( 95 % confidence interval [ CI ] , 0.77 - 3.24 ) . The HR for endometrial cancer was 0.81 ( 95 % CI , 0.48 - 1.36 ) . No appreciable differences were found in the distributions of tumor histology , stage , or grade for either cancer site . The incidence of other gynecologic cancers was low and did not differ by r and omization assignment . More women taking estrogen plus progestin required endometrial biopsies ( 33 % vs 6 % ; P risk of ovarian cancer while producing endometrial cancer rates similar to placebo . The increased burden of endometrial biopsies required to assess vaginal bleeding further limits the acceptability of this regimen . These data provide additional support for caution in the use of continuous combined hormones",
"Objective : To determine the safety and efficacy of an oral soy isoflavone extract for relief of menopausal hot flushes . Design : This was a double‐blind , r and omized , parallel group , outpatient , multicenter ( 15 sites ) study . A total of 177 postmenopausal women ( mean age = 55 years ) who were experiencing five or more hot flushes per day were r and omized to receive either soy isoflavone extract ( total of 50 mg genistin and daidzin per day ) or placebo . Physical examinations and endometrial and biochemical evaluations were performed upon admission and completion . Body weight , symptoms , and safety were evaluated at all visits . Results : Relief of vasomotor symptoms was observed in both groups . Decreases in the incidence and severity of hot flushes occurred as soon as 2 weeks in the soy group , whereas the placebo group experienced no relief for the first 4 weeks . Differences between evaluable subjects in both groups were statistically significant over 6 weeks ( p = 0.03 ) . Over 12 weeks , between‐group differences approached significance ( p = 0.08 ) . Endometrial thickness evaluated by ultrasound , lipoproteins , bone markers , sex hormone‐binding globulin and follicle‐stimulating hormone , and vaginal cytology did not change in either group . Conclusions : Soy isoflavone extract was effective in reducing frequency and severity of flushes and did not stimulate the endometrium . Soy isoflavone extracts provide an attractive addition to the choices available for relief of hot flushes . ( Menopause 2000;7:236‐242 . © 2000 , The North American Menopause Society .",
"Background : Due to symptoms and its complications , menopause influences the mental , psychological and physical health , social performance and familial relationships . Because of the undesirable side effects of hormone replacement therapy , tendency and desire toward alternative treatments in relieving menopausal symptoms have increased . Among the alternative therapies are herbs and among those , herbs with phytoestrogens are more preferable . Red clover is a rich source of phytoestrogens . The present study investigated the effect of red clover on quality of life in post-menopausal women . Material s and Methods : In a r and omized , triple-blind , placebo-controlled clinical trial , 72 menopausal women who at least obtained 15 scores in Kupperman Menopausal Index , after two weeks of monitoring , were r and omly allocated to receive either placebo or 45 mg of red clover isoflavones for eight weeks . Before the treatment and at the end of the study , menopause-specific quality of life question naire ( MENQOL ) was completed in the two groups . Findings : A total of 55 women completed the study , 28 subjects in red clover and 27 in placebo group . Mean score of total quality of life ( p mean score of quality of life in vasomotor domain ( p psycho-social domain ( p physical domain ( p total quality of life nor for its domains . Red clover had no side effects and all the subjects in the red clover group were satisfied with the prescribed administration Conclusions : In the present study , the effect of red clover supplementation on menopausal women 's quality of life showed no difference with the placebo . Further clinical trials are recommended",
"Objective To assess the effect of daily dietary supplementation of soy protein isolate powder on hot flushes in post-menopausal women . Methods We carried out a double-blind , parallel , multi-center , r and omized placebo-controlled trial of 104 post-menopausal women . Fifty-one patients ( age range 48–61 years ) took 60 g of isolated soy protein daily and 53 patients ( age range 45–62 years ) took 60 g of placebo ( casein ) daily . The study lasted 12 weeks . Using analysis of covariance , we analyzed changes from baseline in mean number of moderate to severe hot flushes ( including night sweats ) during treatment . Results Soy was significantly superior to placebo ( P reducing the mean number of hot flushes per 24 hours after 4 , 8 , and 12 weeks of treatment . In particular , women taking soy had a 26 % reduction in the mean number of hot flushes by week 3 and a 33 % reduction by week 4 ( P soy had a 45 % reduction in their daily hot flushes versus a 30 % reduction obtained with the placebo ( P The overall rates of adverse effects were similar for soy and casein-placebo . Twenty-five patients dropped out of the study : 11 in the soy group and 14 in the placebo group . Gastrointestinal side effects were the most common cause of premature withdrawal from the study ( seven patients in each group ) . Conclusion Soy protein isolate added daily to the diet substantially reduced the frequency of hot flushes in climacteric women",
"Objective : To evaluate in a 12-month , prospect i ve , r and omized , double-blind , placebo-controlled study whether pure administration of the phytoestrogen genistein ( 54 mg/d ) might reduce the number and severity of hot flushes in postmenopausal women with no adverse effect on the endometrium . Design : A total of 389 participants met the main study criteria and were r and omly assigned to receive the phytoestrogen genistein ( n = 198 ) or placebo ( n = 191 ) . About 40 % of participants in both groups did not suffer from hot flushes , and the evaluation was performed in a subgroup of 247 participants ( genistein , n = 125 ; placebo , n = 122 ) . Reductions from baseline in the frequency and severity of hot flushes were the principal criteria of efficacy . Endometrial thickness was evaluated by ultrasonography . The maturation value was also used to determine hormonal action on the vaginal cells . Results : There were no significant differences in age , time since menopause , body mass index , and vasomotor symptoms between groups at baseline ( 4.4 ± 0.33 hot flushes per day in the genistein group and 4.2 ± 0.35 hot flushes per day in the control group ) . The effect was already evident in the first month and reached its peak after 12 months of genistein therapy ( −56.4 % reduction in the mean number of hot flushes ) . Furthermore , there was a significant difference between the two groups at each evaluation time ( 1 , 3 , 6 , and 12 months ) . No significant difference was found in mean endometrial thickness and maturation value score between the two groups , either at baseline or after 12 months . Conclusions : The phytoestrogen genistein has been shown to be effective on vasomotor symptoms without an adverse effect on endometrium",
"Purpose To compare Pueraria mirifica 25 and 50 mg dosages to relieve menopausal symptoms . Methods A double-blind study was conducted on 52 hysterectomized women with menopausal symptoms who had an indication for hormone therapy . The women were r and omly allocated into two groups receiving either Pueraria mirifica 25 mg tablet ( Arm A ; n = 26 ) or Pueraria mirifica 50 mg ( Arm B ; n = 26 ) for 6 months . Menopausal symptoms , physical examination findings , and laboratory data were recorded at baseline . Symptoms were reevaluated at 3 and 6 months , while physical and laboratory examinations were evaluated at 1 month and at the end of treatment . A modified Green climacteric scale was used to evaluate menopausal symptoms ; a score of ≥15 indicated estrogen deficiency . Results All women completed the study . Mean baseline climacteric scores of women who received 25 and 50 mg were : 24.19 ± 9.11 versus 23.19 ± 7.89 , respectively ( p = 0.674 ) . After 3 and 6 months of treatment , scores were 17.92 ± 10.40 versus 15.35 ± 8.44 ( p = 0.332 ) and 14.08 ± 10.30 versus 12.46 ± 6.38 ( p = 0.500 ) , respectively . No significant side effects were observed with Pueraria mirifica 25 or 50 mg . Conclusions Both dosages of Pueraria mirifica were similarly effective and safe in the treatment of menopausal symptoms",
"OBJECTIVE To evaluate the preliminary efficacy and safety of Pueraria mirifica ( Kwao Keur Kao ) , phytoestrogen , for the alleviation of climacteric symptoms . MATERIAL AND METHOD Perimenopausal women attending with climacteric symptoms , such as hot flushes and night sweats , were invited to join the present study , conducted at the Menopausal Clinic , Hat Yai Regional Hospital . The patients were voluntarily enrolled and r and omly received the raw material of Pueraria mirifica , oral 50 and 100 mg capsule , once daily for six months , as an open-label study . RESULTS Of the 10 enrolled patients , 8 cases were completely evaluated . The modified Greene climacteric scale ( MGCS ) was satisfactorily decreased in both groups . The average scale declined from 44.1 at baseline , to be 26 , 17 , and 11.1 at 1- , 3- , and 6- month follow-up respectively . No other laboratory abnormalities , except one case had transiently increased the creatinine level , and one case of increased blood urea nitrogen . The mean serum estradiol was slightly increased , while the mean serum follicle-stimulating hormone ( FSH ) and luteinizing hormone ( LH ) were nearly stable . CONCLUSION Pueraria mirifica is relatively safe and preliminarily alleviates the climacteric symptoms in perimenopausal . women , but the data is insufficient to draw definite conclusions regarding the estrogenic effect",
"Introduction Isoflavones are hypothesized to protect against breast cancer , but it is not clear whether they act as oestrogens or anti-oestrogens in breast tissue . Our aim was to determine the effects of taking a red clover-derived isoflavone supplement daily for 1 year on mammographic breast density . Effects on oestradiol , follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , lymphocyte tyrosine kinase activity and menopausal symptoms were also assessed . Methods A total of 205 women ( age range 49–65 years ) with Wolfe P2 or DY mammographic breast patterns were r and omly assigned to receive either a red clover-derived isoflavone tablet ( 26 mg biochanin A , 16 mg formononetin , 1 mg genistein and 0.5 mg daidzein ) or placebo . Change in mammographic breast density , serum oestradiol , FSH , LH , menopausal symptoms and lymphocyte tyrosine kinase activity from baseline to 12 months were assessed . Results A total of 177 women completed the trial . Mammographic breast density decreased in both groups but the difference between the treatment and placebo was not statistically significant . There was a significant interaction between treatment group and oestrogen receptor ( ESR1 ) PvuII polymorphism for the change in estimated percentage breast density ( mean ± st and ard deviation ) : TT isoflavone 1.4 ± 12.3 % and TT placebo -9.6 ± 14.2 % ; CT isoflavone -5.2 ± 12.0 % and CT placebo -2.8 ± 10.3 % ; and CC isoflavone -3.4 ± 9.7 % and CC placebo -1.1 ± 9.5 % . There were no statistically significant treatment effects on oestradiol , FSH , or LH ( assessed only in postmenopausal women ) , or on lymphocyte tyrosine kinase activity . Baseline levels of menopausal symptoms were low , and there were no statistically significant treatment effects on frequency of hot flushes or other menopausal symptoms . Conclusion In contrast to studies showing that conventional hormone replacement therapies increase mammographic breast density , the isoflavone supplement did not increase mammographic breast density in this population of women . Furthermore , there were no effects on oestradiol , gonadotrophins , lymphocyte tyrosine kinase activity , or menopausal symptoms ",
"BACKGROUND Soy isoflavones are naturally occurring phytochemicals with weak estrogenic cellular effects . Despite numerous clinical trials of short-term isoflavone supplementation , there is a paucity of data regarding longer-term outcomes and safety . OBJECTIVE Our aim was to evaluate the clinical outcomes of soy hypocotyl isoflavone supplementation in healthy menopausal women as a secondary outcome of a trial on bone health . DESIGN A multicenter , r and omized , double-blind , placebo-controlled 24-mo trial was conducted to assess the effects of daily supplementation with 80 or 120 mg aglycone equivalent soy hypocotyl isoflavones plus calcium and vitamin D on the health of 403 postmenopausal women . At baseline and after 1 and 2 y , clinical blood chemistry values were measured and a well-woman examination was conducted , which included a mammogram and a Papanicolaou test . A cohort also underwent transvaginal ultrasound measurements to assess endometrial thickness and fibroids . RESULTS The baseline characteristics of the groups were similar . After 2 y of daily isoflavone exposure , all clinical chemistry values remained within the normal range . The only variable that changed significantly was blood urea nitrogen , which increased significantly after 2 y ( P = 0.048 ) but not after 1 y ( P = 0.343 ) in the supplementation groups . Isoflavone supplementation did not affect blood lymphocyte or serum free thyroxine concentrations . No significant differences in endometrial thickness or fibroids were observed between the groups . Two serious adverse events were detected ( one case of breast cancer and one case of estrogen receptor-negative endometrial cancer ) , which was less than the expected population rate for these cancers . CONCLUSION Daily supplementation for 2 y with 80 - 120 mg soy hypocotyl isoflavones has minimal risk in healthy menopausal women . This trial was registered at clinical trials.gov as NCT00665860",
"Plants contain compounds with oestrogen -- like action called phytoestrogens . Soy contains daidzin , a potent phytoestrogen , and wheat flour contains less potent enterolactones . We aim ed to show in 58 postmenopausal women ( age 54 , range 30 - 70 years ) with at least 14 hot flushes per week , that their daily diet supplemented with soy flour ( n = 28 ) could reduce flushes compared with wheat flour ( n = 30 ) over 12 weeks when r and omised and double blind . Hot flushes significantly decreased in the soy and wheat flour groups ( 40 % and 25 % reduction , respectively Menopausal symptom score decreased significantly in both groups ( P Urinary daidzein excretion confirmed compliance . Vaginal cell maturation , plasma lipids and urinary calcium remained unchanged . Serum FSH decreased and urinary hydroxyproline increased in the wheat flour group",
"INTRODUCTION In recent years , considerable attention has been paid to isoflavones and their proprieties to alleviate the climacteric symptoms . The goal of this study was to evaluate the efficacy of st and ardized isoflavones extract ( Soyfem ) in moderate and medium-severe climacteric syndrome . MATERIAL AND METHODS 555 postmenopausal women were recruited for the study . Out of this group , 169 women completed the study ( 12-month observation period ) . The patients were classified according to the intensity of climacteric symptoms ( tablets of Soyfem were administered twice a day . RESULTS A regular decrease of Kupperman index value and improvement of life quality were observed in the group of 169 postmenopausal women . We have noted a decrease in the intensity and number of hot flushes , diaphoresis ( p diminished sleep disturbances ( p decreased headache , dizziness , and arthrosis pain . The diminished intensity of tiredness , palpitation and breathlessness have been also observed ( p regression of paresthesis , 20 % indicated the decreased number of paresthesis ( p Soyfem on the variability and moderation of depressive mood ( p Soyfem in the dosage 52 to 104 mg/24 hours ( 2 times daily 1 or 2 tablets ) is a safe and effective therapy in the postmenopausal women with moderate and medium-severe climacteric syndrome evaluated according to the Kupperman index . Administration of Soyfem is connected with a good compliance and correlated with well-being in the investigated women allowing a long-term administration",
"OBJECTIVE To evaluate the effect of soy isoflavones on menopausal symptoms in women who do and who do not produce equol , a daidzein metabolite . METHOD A r and omized , double-blind , placebo-controlled clinical trial was conducted over 6 months with 96 healthy menopausal women . After taking take 135 mg of isoflavones daily for 1 week , the women in the study group were assigned to the equol-producing ( EP ) or the non-EP group according to the presence or absence of equol in their urine . Menopausal symptoms were evaluated using a modified Kupperman Index . RESULT Compared with the placebo group , the scores for hot flashes and excessive sweating were significantly reduced after 3 months , and the scores for weakness , palpitations , limb paresthesia , and total symptoms after 6 months , in the EP group only . CONCLUSIONS Isoflavone supplementation improves menopausal symptoms only in women with the ability to produce equol",
"UNLABELLED In climacteric women with contraindications and fear or lack of compliance for taking hormonal replacement therapy as well as in those cases where risks exceed benefits , the use of phytoestrogens is appropriate having in mind their especially good effect on neurovegetative symptoms . AIM The present r and omized prospect i ve study is aim ed at estimating the possibility for ameliorating climacteric symptoms with Melbrosia and at assessment of its effect on different symptoms in order to individualize the therapeutical approach . PATIENTS AND METHODS Two groups of women with climacteric complaints were followed-up -- control group ( n = 32 ) and treatment group ( n = 34 ) . Climateric symptoms were assessed in the beginning and at the end of the study using Kupperman menopausal index . The levels of FSH , LH , oestradiol as well as some parameters of lipid metabolism were determined . RESULTS A significant decrease of Kupperman index was observed in Melbrosia treatment group in contrast to the control group . No significant changes in gonadotropins , oestradiol and lipid parameters were found in both groups . CONCLUSION The preparation Melbrosia , consisting of phytoestrogens and amino acids exerts a good therapeutic effect on climacteric symptoms mainly on the nervousness , anxiety , irritability , headache , and hot flashes",
"OBJECTIVE To investigate the effects of st and ardized soy extract on climacteric symptoms , lipid profiles , bone markers , and serum isoflavone concentration in healthy Taiwanese postmenopausal women . MATERIAL S AND METHODS A multicenter , open-labeled , r and omized , prospect i ve , comparative study design was used . A total of 130 out patients who had undergone natural menopause were r and omly administered either 70 mg or 35 mg soy extract daily for 24 weeks . RESULTS The evidence suggests that the soy extract treatment that was administered to both groups for 1 month could help reduce climacteric scores ( reductions of 19.66 % [ p total cholesterol ( reductions of 4.50 % [ p low density lipoprotein cholesterol levels ( reductions of 4.67 % [ p cholesterol > 200 mg/dL after 6 months of treatment . In patients with high bone turnover ( urinary deoxypyridinoline/creatinine > 7.4 nM/mM ) , soy extract treatment reduced the deoxypyridinoline/creatinine level by 10.53 % ( p Serum levels of isoflavone increased in both groups after 6 months of treatment . CONCLUSION Soy extract is highly efficacious at relieving menopausal symptoms and demonstrates a positive effect on the cardiovascular system and skeleton",
"OBJECTIVE To investigate the relationship between levels of phytoestrogens in blood and urine and symptom control in postmenopausal women whose diets were supplemented with soy containing high levels of phytoestrogen . METHODS Phytoestrogen levels in blood and urine were correlated with the number of hot flushes and vaginal maturation indices in 104 postmenopausal women whose diets were supplemented with 60 g of soy powder daily for 3 months in a double-masked , parallel , placebo-controlled trial . The effect of soy supplementation on menopausal symptoms in this study population was reported previously . RESULTS Serum levels of genistin , daidzin , and equol were significantly higher in women after soy diet supplementation ( + 756 % , + 593 % , + 1008 % , and 57 % respectively ) . The concentration of enterolactone in the soy group was increased by 57 % compared with baseline , but the difference with placebo was not statistically significant . The increase in phytoestrogen levels in the soy group in blood or urine did not correlate with fewer hot flushes . Vaginal maturation indices did not change in the soy group . CONCLUSION Phytoestrogen levels increased in women who consumed soy supplement , but that does not fully explain climacteric symptom reduction . It is possible that other types of yet unknown phytoestrogens or components in soy other than phytoestrogen influence hot flushes",
"Objective : The Hilo Women 's Health Survey was design ed and administered to gather baseline data on women 's health in Hilo , HI . This r and omized , cross-sectional study allowed for a focus on ethnic differences in symptom reporting . The results presented here focus on hot flash and night sweat experience among Japanese-American and European-American women . Design : Survey packets were mailed to street addresses associated with parcel numbers pulled r and omly from Hilo tax maps . Of the 6,401 survey packets delivered to households , 1,824 question naires were completed and returned . The results reported here are based on 869 women aged 40 to 60 , of whom 249 described themselves to be 100 % Japanese and 203 described themselves to be 100 % European-American . Logistic regression analyses were used to examine whether the relationship between ethnicity and vasomotor symptoms persisted after controlling for other variables . Results : European-American participants were more likely to have ever experienced a hot flash as compared with Japanese-American participants ( 72 % vs 53 % , P hot flashes ( P night sweats ( P hot flashes ( odds ratio = 1.858 ) and night sweats ( odds ratio = 2.672 ) . Conclusions : The results , based on self-reporting of menopausal symptoms , indicate that Japanese-American women report fewer hot flashes and night sweats than European-American women . Japanese-American women reported a higher intake of soy , but soy intake was not associated with fewer vasomotor symptoms",
"Context Since 1998 , 2 large trials have drastically changed the evidence for the preventive health benefits of postmenopausal hormone replacement therapy . However , changes in practice often lag behind changes in evidence . Contribution Among mammography recipients in San Francisco , California , the use of hormone replacement therapy decreased 1 % per quarter after publication of the Heart and Estrogen/progestin Replacement Study and 18 % per quarter after publication of results from the Women 's Health Initiative ( WHI ) . Reduction in use was unrelated to a woman 's age , hysterectomy status , or race or ethnicity . Implication s The WHI result ed in more dramatic changes in practice than are often associated with changes in evidence . The vigorous media coverage of the WHI may have contributed to rapid changes in practice . The Editors In 1995 , approximately 38 % of postmenopausal women in the United States were taking hormone therapy ( 1 ) . At that time , several observational studies had suggested that hormone therapy offered women some protection against coronary heart disease and osteoporosis ( 2 - 5 ) . A decision analysis published in 1997 concluded that the benefits of hormone therapy outweighed its risks for nearly all women ( 6 ) . More recently , the results from 2 large r and omized clinical trials , the Heart and Estrogen/progestin Replacement Study ( HERS ) ( 7 ) and the Women 's Health Initiative ( WHI ) , have been published ( 8) . These clinical trials demonstrated that the risks associated with hormone therapy outweigh the benefits for women taking continuous estrogen and progestin regimens . As a result of these trial results , the U.S. Food and Drug Administration required new warning labels for all estrogen products ( 9 ) , and the U.S. Preventive Services Task Force revised its assessment of hormone therapy to recommend against the routine use of estrogen and progestin for the prevention of chronic conditions in postmenopausal women ( 10 ) . It is important to underst and whether this new scientific evidence is changing the use of hormone therapy . Of note , the results of the WHI were widely disseminated . Despite this publicity , differential access to new information , varied interpretations of study findings , and individual perceptions of menopausal symptoms and hormone side effects may have result ed in different patterns of use . An underst and ing of how use is changing over time provides important information about the dissemination of clinical trial results to women . We design ed our analysis to examine whether the use of hormone therapy has changed among postmenopausal women as a result of the publication of the results from HERS and the WHI . We were also interested in examining whether patterns of use differ by patient characteristics . Because HERS examined the outcomes of older women , we hypothesized that there would be earlier and more substantial declines in hormone therapy use among this group . We also expected that there would be variation in use by race or ethnicity because white women may have better access to new information ( 11 ) . Finally , because the WHI study results were specific to women taking continuous estrogen plus progestin , we hypothesized that hormone use would be more stable among women who had had hysterectomies because such women typically take only estrogen and may believe that the findings do not apply to them . Methods Sample The San Francisco Mammography Registry is a population -based registry of women undergoing mammography in San Francisco , California . It is 1 of 7 registries participating in the National Cancer Institute Breast Cancer Surveillance Consortium ( 12 ) . This registry began to prospect ively collect patient data and mammography results in 1995 and currently captures about 90 % of mammography examinations performed in San Francisco . Data from 11 mammography facilities are included in this analysis . Women were eligible for this analysis if they were between the ages of 50 to 74 years , were postmenopausal , did not report a personal history of breast cancer , and underwent screening or diagnostic mammography between January 1997 and 19 May 2003 . Women 55 years of age and older were assumed to be menopausal . Women 50 to 54 years of age were considered to be menopausal if both ovaries had been removed or if they reported that their periods had stopped permanently . For women who had mammography more than once in any calendar year , we included only the first instance of mammography in that year to prevent overrepresentation of women undergoing an evaluation of an abnormal mammogram because this experience may influence use of hormone therapy . Our final sample included 15 1862 mammograms received by 71 219 women . Data At the facilities that participate in the San Francisco Mammography Registry , each woman completes a brief , scannable question naire at the time of mammography . This question naire collects information about current use of hormone therapy and several personal characteristics , including race or ethnicity ( categorized as white , African American , Latina , Chinese , Filipina , other Asian , other ) , family history of breast cancer ( including mother , sisters , and daughters ) , history of childbirth , whether the woman had undergone a hysterectomy , menopausal status , history of breast biopsy ( including fine-needle aspiration , core biopsy , and surgical biopsy ) . Information about age at the time of mammography , date of mammography , and ZIP code of residence is reported by the facility . Data from the year 2000 U.S. Census was used to assign median income for each woman 's ZIP code of residence as a proxy for socioeconomic status . Variables Our outcome variable for this analysis was the current use of hormone therapy . Date of mammography was represented as a linear term . Binary variables were created for the publication date s of HERS ( before 19 August 1998 vs. that date or later ) and the publication of the principal findings from the WHI ( before 17 July 2002 vs. that date or later ) . Other independent variables examined were age at the time of mammography , race or ethnicity , median income of the ZIP code of residence , history of childbirth , family history of breast cancer , history of breast biopsy , and previous hysterectomy . Statistical Analysis Because some of the women in this sample had more than 1 mammogram represented in this data set , which spanned a 7-year period , we conducted a repeated- measures logistic regression to adjust the variance estimates for clustering of hormone therapy use over time for individual women and for the clustering of women within mammography facilities ( 13 ) . Generalized estimating equations were implemented by using the SUDAAN statistical package , version 8.0.0 ( Research Triangle Institute , Research Triangle Park , North Carolina ) assuming an exchangeable correlation matrix . These models included a linear term indicating quarter from January 1997 to the first quarter of 2003 to control for temporal trends ( the last quarter included mammograms through 19 May 2003 ) , the variables specified above to indicate the date s of publication of HERS and the WHI , and an interaction term between each of these publication indicators and the time ( in quarters ) following each of these publications to measure changes in use after the publication of these clinical trials . These models also controlled for the individual characteristics described earlier ( that is , age , race or ethnicity , history of childbirth , family history of breast cancer , history of breast biopsy , previous hysterectomy , median income for the ZIP code of residence ) . To specifically test our hypotheses about differential changes in the use of hormone therapy for subgroups of women on the basis of age , hysterectomy status , and race or ethnicity , we examined interaction terms to test for effect modification . For the main effects , a P value less than 0.05 was considered statistically significant , and for the interaction terms , a P value less than 0.01 was considered to be statistically significant . The likelihood ratio test compared the None model with the fitted model . Role of the Funding Source This work was supported by a National Cancer Institutefunded Breast Cancer Surveillance Consortium agreement . The funding source did not participate in the design , conduct , or reporting of this analysis or in the decision to su bmi t the manuscript for publication . Results The Table shows the characteristics of the sample for each of the study years . Over the time period of the study , the median age decreased from 61 years to 59 years . The racial and ethnic composition of the sample also changed somewhat across the study years . Fewer women undergoing mammography in 2003 reported a history of childbirth ( 71.7 % vs. 75.2 % ) or hysterectomy than did women undergoing mammography in 1997 . Conversely , more women reported a family history of breast cancer ( 17.1 % vs. 11.8 % ) or a personal history of a previous breast biopsy or aspiration . The average number of mammograms obtained for each woman in our sample across the 7-year study period was 2.1 ( range , 1 to 7 ) . Table . Description of the Sample ( 151 862 Mammograms ) The Figure shows the unadjusted rates of current hormone therapy use by month for all of the women in the sample . Among menopausal women who had received mammography , we estimated that the average proportion reporting the current use of hormone therapy was 41 % in 1997 . In 1997 , hormone use was highest among white women ( 52.6 % ) and lowest among African-American women ( 34.1 % ) , Latina women ( 33.9 % ) , Chinese women ( 32.2 % ) , and Filipina women ( 29.6 % ) . In 1997 , hormone use was higher among younger women than older women ( 48.7 % vs. 28.7 % ; P Rates of hormone therapy use among postmenopausal women , 1997 to 2003 HERS WHI The adjusted multivariate model estimates that before the publication of HERS , the use of hormone",
"Background and objectives : The potential of soy isoflavones to interfere with thyroid function has been reported . However , there are limited data regarding their effect on thyroid function and autoimmunity in surgical menopausal women . The present study aim ed to evaluate the effect of isoflavones on thyroid function and autoimmunity , menopausal symptoms , serum follicle stimulating hormone ( FSH ) and estradiol levels in oophorectomised women . Methods : A r and omized , double blind , placebo-controlled trial was conducted in 43 oophorectomised women to evaluate the effect of soy isoflavones ( 75 mg/day for 12 wk ) on serum thyroid profile ( free T3 , free T4 , TSH , TBG and anti-TPO antibody titres ) assessed at baseline , 6 and 12 wk after r and omization . Assessment was also done for menopause symptom score ( MSS ) three weekly , and FSH and estradiol levels at baseline and at study completion . Results : There was a significant alteration in free T 3 levels in the group receiving isoflavones ( 4.05 ± 0.36 , 4.12 ± 0.69 and 3.76 ± 0.55 pmol/l at baseline , 6 and 12 wk , respectively ; P=0.02 ) . However , the mean change in various thyroid parameters at 12 wk from baseline was not significantly different between the two groups . MSS was also significantly decreased at 9 and 12 wk from baseline with isoflavones ( 12.47 ± 8.15 , 9.35 ± 5.23 and 9 ± 5.14 at baseline , 9 and 12 wk respectively ; P=0.004 ) with significant improvement in urogenital symptoms compared to placebo . Isoflavones did not significantly affect other parameters during study period . There were no serious adverse events reported and the proportion of patients experiencing adverse events was similar between the two groups . Interpretation and conclusions : Modest reduction in serum free T3 levels in the isoflavone group in the absence of any effect on other thyroid parameters might be considered clinical ly unimportant",
"Context Caution about taking estrogen for treating postmenopausal vasomotor symptoms has led to increasing substitution of herbal regimens despite few tests of their effectiveness . Contribution The authors r and omly assigned 351 perimenopausal or postmenopausal women to herbal treatments ( black cohosh , multibotanicals , or multibotanicals plus counseling about dietary soy ) , estrogen with or without progesterone , or placebo . At 3 , 6 , and 12 months , patients receiving the herbal interventions had the same change in vasomotor symptoms as those receiving placebo ( except for more severe symptoms at 12 months for patients taking multibotanicals plus dietary soy ) . Estrogen substantially decreased vasomotor symptoms . Caution s Most participants were white and were well-educated . Implication s Herbal regimens did not reduce postmenopausal vasomotor symptoms in this sample of women . The Editors Hormone therapy remains the recommended treatment for vasomotor symptoms , but trials have shown serious risks with even short-term use ( 1 , 2 ) . The use of herbs , particularly black cohosh , multibotanical supplements , and dietary soy for menopausal symptoms has grown dramatically ( 36 ) . Few of these approaches have been scientifically evaluated . Women and providers are seeking safe , effective alternatives to hormone therapy . We design ed the Herbal Alternatives for Menopause Trial ( HALT ) to provide rigorous evidence on the efficacy and short-term safety of commonly used naturopathic approaches for management of vasomotor symptoms . Methods Design Overview and Setting HALT was a 1-year double-blind , r and omized , controlled trial design ed to investigate the effects of 3 naturopathic approaches for vasomotor symptom relief and hormone therapy compared with placebo . Study methods have been described elsewhere ( 7 ) . The Group Health Institutional Review Board approved this study , and a data and safety monitoring committee monitored it . The study was conducted at Group Health , an integrated health plan in Washington State . Participants Eligibility criteria were as follows : age 45 to 55 years ; late menopausal transition ( 1 skipped menses within the preceding 12 months ) or postmenopausal ( no bleeding within 12 months , or follicle-stimulating hormone level > 20 IU/mL if patient had undergone hysterectomy without bilateral oophorectomy ) ; and 2 or more vasomotor symptoms per day over 2 weeks ( 6 moderate to severe symptoms ) . Women in menopausal transition were included because many are highly symptomatic and trial data are lacking for this group . Exclusion criteria were the following : contraindications to hormone therapy ; use of hormone therapy or oral contraceptives within 3 months before the trial ; use of herbal medicines for menopausal symptoms within 1 month before the trial ; soy allergy ; bilateral oophorectomy ; history of breast cancer ; and nonadherence during the run-in period ( 80 % of capsules taken ) . From May 2001 through August 2003 , women were recruited by using direct mail . Screening calls determined initial eligibility . Women attended an orientation visit at which eligibility was confirmed , physical measurements were collected , and placebo medication and question naires for the 2-week run-in period were provided . R and omization and Interventions Participants were r and omly assigned by using SAS software ( SAS Institute , Inc. , Cary , North Carolina ) , stratified by previous hormone therapy and hysterectomy ; block sizes within strata ranged from 5 to 25 . Treatment assignments were sent to the University of Washington Research Pharmacy , where medications were bottled and labeled with a sequential identification number without treatment group indication . At the r and omization visit , vasomotor symptom diaries and medication counts were examined to confirm eligibility and adherence . The study nurse determined the appropriate stratum , assigned the participant the next study number in that stratum without knowledge of group assignment , and distributed study medications . The publication of results from the Women 's Health Initiative ( WHI ) estrogenprogestin trial ( 2 ) raised new concerns about the safety of estrogen therapy . New study participants were given the choice of 5-arm ( including hormone therapy ) versus 4-arm ( no hormone therapy ) r and omization . Current participants gave consent again , incorporating risk estimates from the WHI , and were given the option of finding out whether they had been assigned to hormone therapy ; 16 were unblinded , 1 discontinued use of the study drug , and all remained enrolled . Following publication of the WHI Memory Study ( 8 , 9 ) , we informed participants of those findings and restricted r and omization to herbs and placebo . No further women were unblinded or discontinued use of the study drug . Naturopathic medicine provided the model for study interventions . The herbal products , doses , and soy diet were based on approaches used by naturopaths when the study was design ed ( 7 ) . The study groups were as follows : 1 ) black cohosh ( Actaea racemosa or Cimicifuga racemosa , 160 mg daily ; 2.5 % triterpene glycosides ; 70 % ethanol extract ) ; 2 ) multibotanical ; 3 ) multibotanical plus soy diet counseling ; 4 ) conjugated equine estrogen , 0.625 mg daily , with ( for women with a uterus ) or without ( for women without a uterus ) medroxyprogesterone acetate , 2.5 mg ; and 5 ) placebo . The multibotanical delivered daily doses of the following : black cohosh , 200 mg ; alfalfa ( Medicago sativa ) , 400 mg ; boron , 4 mg ; chaste tree ( Vitex agnus-castus ) , 200 mg ; dong quai ( Angelica sinensis ) , 400 mg ; false unicorn ( Chamaelirium luteum ) , 200 mg ; licorice ( Glycyrrhiza glabra ) , 200 mg ; oats ( Avena sativa ) , 400 mg ; pomegranate ( Punica granatum ) , 400 mg ; Siberian ginseng ( Eleutherococcus senticosus , st and ardized constituents 0.8 % eleutherosides E and B ) , 400 mg . Black cohosh was provided by Pure World , Inc. , ( Hackensack , New Jersey ) . The multibotanical , ProGyne , was purchased from Progena Professional Formulations ( Albuquerque , New Mexico ) and encapsulated to study specifications . Both companies follow current good manufacturing practice s , and single batches were used . ConsumerLab.com ( White Plains , New York ) tested the products after the study commenced . Dong quai , false unicorn , and pomegranate were not detected , suggesting that they were of poor quality or did not contain the tested marker compounds . Other marker compounds were detected in the approximate doses as labeled ( 7 ) . The Appendix Table describes the herbal products in detail . Appendix Table . Consoli date d St and ards of Reporting Trials ( CONSORT ) Requirements for Controlled Trials of Herbal Interventions To facilitate blinding , medications and lactose placebo were encapsulated to provide 2 white and 2 blue capsules to each woman , and medication boxes were labeled with a unique identification number that did not indicate study group . The soy food intervention was modeled after a successful 5-a-day intervention ( 10 ) . We chose soy foods because of uncertainty about the efficacy of isoflavone supplements and because naturopaths commonly recommend whole soy foods . Participants received 5 telephone calls from a clinical dietitian and a 34-page booklet recommending 2 soy food servings per day ( 12 to 20 g of soy protein ) ( 7 ) . Other participants received 1 telephone call and a similar booklet reinforcing fruit and vegetable intake . Participants were instructed not to discuss dietitian calls with study nurses and were unaware that soy counseling was linked to the multibotanical . Outcomes and Measurements The primary outcomes were change from baseline ( measured over 2-week run-in period ) to 3 , 6 , and 12 months ( each measured for 4 weeks ) and change from baseline to the average for all follow-ups with regard to the mean frequency and intensity of vasomotor symptoms ( daytime hot flashes plus night sweats ) and the mean Wiklund Vasomotor Symptom Subscale score ( 11 , 12 ) . We also evaluated change from baseline to follow-up ( months 3 , 6 , and 12 and average change ) for daytime hot flash rate , night sweat rate , and the total Wiklund Menopause Symptom Scale score . Symptom diaries and global ratings of menopause symptoms are almost universally used in studies of vasomotor symptoms . Participants used a vasomotor symptom diary to record daytime hot flashes and night sweats , rating intensity as mild , moderate , or severe ( scale , 1 to 3 ) , as recommended by the U.S. Food and Drug Administration ( 13 ) . Women completed the Wiklund Menopause Symptom Scale , rating the severity of 13 menopausal symptoms ( sweats , hot flashes , sleep disturbance , fatigue , vaginal dryness , depression , headache , irritability , muscle/joint pain , breast tenderness , nervousness , palpitations , and dizziness/fainting on a scale of 0 ( none ) to 10 ( severe ) ( 11 ) . Soy food intake was monitored by using a self-reported , vali date d soy food question naire ( 14 ) . Follow-up Procedures Participants returned to the research clinic at 3 , 6 , and 12 months . Question naires were collected , and study medication was dispensed . Medication adherence counts were conducted by staff without participant contact and without knowledge of treatment assignment . Study nurses encouraged adherence and monitored adverse events during monthly telephone calls and at visits . Adverse events were identified through participants ' responses to the question , Have you had any medical problems or been hospitalized ? Responses were recorded and adverse events were followed until they were resolved . The study nurse determined intensity ( mild , moderate , or severe ) and whether the event was serious ( yes or no ) . Events were review ed by the study physician , who determined whether the event was study related , without knowledge of group assignment . Adverse events were coded by using the Coding Symbols for Thesaurus of Adverse Reaction Terms ( 15 ) . The Data and Safety Monitoring Committee review ed study progress and unblinded outcome and safety data 5 times . Statistical Analysis The study was powered to detect an effect of",
"AIM The aim of the present study was to assess the efficacy and safety of a st and ardized compound based on an extract of soy phytoestrogens , with high doses of isoflavones in the management of menopausal hot flushes . METHODS A total of 180 women aged 40 - 65 years with a minimum of five moderate-to-severe hot flushes in the last 7 days at baseline and absence of menstruation for at least 6 months participated in a 12-week prospect i ve , r and omized , double-blind , placebo-controlled multicenter trial . After a 2-week run-in period , women received one tablet a day of 80 mg isoflavones ( corresponding to 60 mg of genistein ) or a matching placebo . RESULTS The mean daily number of moderate-to-severe hot flushes decreased in both study groups , but the reduction was greater in the isoflavones arm at 6 ( 36.2 % ) and 12 weeks ( 41.2 % ) than in the placebo arm ( 24.0 % at 6 weeks , 29.3 % at 12 weeks ) , with a difference of 1.1 ( 95 % CI [ -2.0 to -0.06 ] ) ( P = 0.038 ) at 6 weeks and 1.1 ( 95 % CI [ -2.05 to -0.15 ] ) ( P = 0.023 ) at 12 weeks . Similar findings were obtained for hot flushes of any intensity . The Kupperman index decreased in both study groups . Relief of hot flushes was greater when time to menopause was > or=12 months and in cases of BMI > or=27 kg/m(2 ) . CONCLUSION In daily practice conditions , high doses of isoflavones , particularly genistein , can be used for the management of hot flushes in postmenopausal women not treated with hormone replacement therapy due to their superior efficacy to placebo and very good safety profile",
"The aim of our study was to evaluate the effects of isoflavones on climacteric-related symptoms and on the endometrium in postmenopausal women , in a prospect i ve , open , r and omized , clinical trial performed at the Menopause Clinic of our Department . Seventy postmenopausal women were r and omly assigned to two treatment groups receiving 12 cycles of treatment with genistein ( group A ) or calcium ( group B ) . In all patients ultrasonographic endometrial thickness and Kupperman Index ( KI ) were evaluated at baseline and after 6 and 12 cycles of treatment . At baseline no significant difference was detected in endometrial thickness and in KI between groups A and B. After 6 and 12 cycles of treatment , no significant difference was observed in endometrial thickness between or within groups . Endometrial thickness was lower than 5 mm in all cases before and during treatment except in two cases in group B and in one case in group A after 12 months . At 6 and 12 months , the KI was significantly ( p climacteric symptoms in postmenopausal women and does not increase endometrial thickness",
"Phytoestrogens are increasingly incorporated into the diet of menopausal women . However , there are limited data on the efficacy of flaxseed on the consequences of estrogen deficiency in menopausal women . The purpose of the study was to assess the effects of flaxseed incorporation into the diet of healthy menopausal women . One hundred and ninety-nine menopausal women were r and omly assigned to consume 40 g flaxseed/d ( n = 101 ) or wheat germ placebo ( n = 98 ) for 12 months . At baseline and at month 12 , serum levels of lipids , bone mineral density ( BMD ) , and menopausal symptoms were evaluated . Statistical analysis was performed under the intention to treat principle . Flaxseed reduced serum total ( -0.20 + /- 0.51 mmol/liter ; P = 0.012 ) and high-density lipoprotein ( -0.08 + /- 0.24 mmol/liter ; P = 0.031 ) cholesterol concentrations compared with wheat germ placebo . BMD did not differ significantly between the two arms . Both flaxseed and wheat germ reduced ( P severity scores of menopausal symptoms , but no statistical difference was found between the two arms . Our findings suggest that 1-yr incorporation of flaxseed into the diet produced a favorable , but not clinical ly significant , effect on blood cholesterol and caused no significant change in BMD or symptoms in healthy menopausal women",
"Objective : We evaluated and compared the effects of the phytoestrogen genistein , estrogen-progestogen therapy ( EPT ) , and placebo on hot flushes and endometrial thickness in postmenopausal women . Design : Ninety healthy , postmenopausal women , 47 to 57 years of age , were r and omly assigned to receive for 1 year continuous EPT ( n = 30 ; 1 mg 17β-estradiol combined with 0.5 mg norethisterone acetate ) , the phytoestrogen genistein ( n = 30 ; 54 mg/day ) , or placebo ( n = 30 ) . Endometrial safety was evaluated by intravaginal ultrasounds at baseline , 6 and 12 months . Results : By comparison with placebo , daily flushes reduced significantly by a mean of 22 % ( 95 % CI : −38 to −6.2 ; P treatment . Flush score decreased by a mean of 53 % ( 95 % CI : −79 to −26 ; P placebo . No side effect was observed on the uterus of the participants . Conclusions : The present study confirms that genistein might have positive effects on hot flushes without a negative impact on endometrial thickness and suggests a future role of this phytoestrogen as a strategically therapeutic alternative in the management of postmenopausal symptoms",
"OBJECTIVES To examine the efficacy of a hop extract enriched in 8-prenylnaringenin ( 8-PN , the phytoestrogen in hops , Humulus lupulus L. ) on relief of menopausal discomforts . METHODS A prospect i ve , r and omized , double-blind , placebo-controlled study over 12 weeks with 67 menopausal women , who were administered a hop extract st and ardized on 8-PN ( 100 or 250 microg ) . The responses were determined by means of a modified Kupperman index ( KI ) and a patients ' question naire . RESULTS All groups , including placebo , showed a significant reduction of the KI both after 6 weeks and after 12 weeks . The hop extract at 100 microg 8-PN was significantly superior to placebo after 6 weeks ( P=0.023 ) but not after 12 weeks ( P=0.086 ) . No dose-response relationship could be established , as the higher dose ( 250 microg ) was less active than the lower dose both after 6 weeks and after 12 weeks . Still , a trend for a more rapid decrease of KI was noticed for both active groups as compared to placebo . In particular , the decrease in hot flush score ( isolated from the KI ) was found significant for both treatment groups after 6 weeks ( P placebo . Results of the patients ' question naire were consistent with those of the KI , with the most pronounced effects being observed for the 100-microg treatment . CONCLUSIONS Daily intake of a hop extract , st and ardized on 8-PN as a potent phytoestrogen , exerted favorable effects on vasomotor symptoms and other menopausal discomforts . Hop-derived prenylated flavonoids may provide an attractive addition to the alternative treatments available for relief of hot flushes and other menopausal discomforts",
"Objective : Postmenopausal estrogen decline is implicated in several age-related physical and psychological changes in women , including decreases in perceived quality of life ( QoL ) . A number of trials with hormone therapy showed beneficial effects of the intervention on parameters of quality of life . However , because of known or suspected serious side-effects of conventional hormone therapy there is a need for alternatives . Design : We conducted a double-blind r and omized placebo-controlled trial with soy protein , containing 52 mg genistein , 41 mg daidzein , and 6 mg glycitein ( aglycone weights ) , or milk protein ( placebo ) daily for 1 year . For this trial , we recruited 202 postmenopausal women aged 60 to 75 years . Results : At baseline and at final visit , participants filled in the Short Form of 36 questions ( SF-36 ) , the Question naire on Life Satisfaction Modules ( QLSM ) , and the Geriatric Depression Scale ( GDS ) . For the placebo group scores on all dimensions of the SF-36 and the QLSM decreased during the intervention year , except for the dimension \" role limitations caused by physical problems . \" The soy group showed increases on two dimensions of the SF-36 ( \" social functioning \" and \" role limitations caused by physical problems \" ) and on one dimension of the QLSM . There were however no statistically significant differences in changes of scores between the two intervention groups . For the GDS similarly , no significant differences were found between the groups . Conclusions : In conclusion , the findings in this r and omized trial do not support the presence of a marked effect of soy protein substitution on quality of life ( health status , life satisfaction , and depression ) in elderly postmenopausal women",
"Objective To investigate the effect of an oral soy isoflavone extract ( Phytosoya ) on hot flushes in menopausal women . Design The study was conducted on out patients according to a multicenter , r and omized , double-blind , placebo-controlled , parallel-group design . A total of 75 patients in natural or surgical menopause suffering from at least seven hot flushes per day were r and omized to receive during 4 months either soy isoflavone extract ( total of 70 mg genistin and daidzin per day ) or placebo . Results There is evidence to suggest that 16 weeks of treatment with soy extract can help reduce the mean number of hot flushes per 24 hours in menopausal women . Withdrawals during this trial made it difficult to obtain an unbiased estimate of the true treatment effect , but numerous sensitivity analyses lend support to the suggestion that taking soy extract can be beneficial in the treatment of hot flushes . In particular , women taking soy extract had a 38 % reduction in the mean number of hot flushes by week 4 and a 51 % reduction by week 8 . By the end of week 16 , patients taking soy extract had a 61 % reduction in their daily hot flushes versus a 21 % reduction obtained with the placebo . “ Responders ” ( defined as patients whose hot flushes were reduced by at least 50 % at the end of treatment period ) were 65.8 % in the soy extract group and 34.2 % in the placebo group ( p isoflavone extract may help to reduce the frequency of hot flushes in climacteric women and provides an attractive addition to the choices available for relief of hot flushes",
"Objective Estrogen therapy is , to date , the most effective treatment of menopausal syndrome and also has a favorable effect on lipid profiles . Because of its potential adverse effects , however , a more acceptable alternative therapy needs to be identified . This study examines the effect of soy germ isoflavones on menopausal symptoms and serum lipids . Methods Ninety early postmenopausal Chinese women , aged 45 to 60 years , were r and omly assigned to three treatment groups ( 30 each ) receiving daily doses of 0 ( placebo ) , 84 , and 126 mg of soy germ isoflavones . Hot flush frequency , Kupperman scores , serum 17&bgr;-estradiol , follicle-stimulating hormone , luteinizing hormone , and serum lipids , including triglyceride , total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , apolipoprotein A-I , and apolipoprotein B100 , were assessed at baseline and at 12 and 24 weeks after treatment . Results Both the frequency of hot flushes and the Kupperman index score decreased in all three treatment groups during the intervention period , but the percentage decreases in both were significantly greater in the two isoflavone groups ( 44.3 ± 19.1 and 57.8 ± 37.4 [ 84 mg isoflavones ] ; 48.5 ± 27.2 and 56.7 ± 26.7 [ 126 mg isoflavones ] ) than in the placebo group ( 27.8 ± 15.5 and 34.6 ± 46.2 ; p changes in estradiol , follicle-stimulating hormone , and luteinizing hormone among the three treatment groups during the study , and no significant differences were observed in the lipid components . Conclusions A daily supplement of 84 or 126 mg soy germ isoflavones may improve menopausal symptoms , although neither dose was found to affect lipid profiles in early postmenopausal Chinese women after 24 weeks of treatment . The favorable effects are unlikely to be associated with female hormones",
"OBJECTIVE To determine the effect of soy-derived isoflavones on hot flushes , endometrial thickness , and the vascular reactivity of uterine and cerebral arteries . DESIGN Double-blind , r and omized , placebo-controlled trial . SETTING Healthy volunteers in an academic research environment . PATIENT(S ) Sixty-two postmenopausal women aged 45 - 60 years attending the Outpatient Menopause Clinic of our gynecological departments . INTERVENTION(S ) The patients were administered 72 mg of soy-derived isoflavones or placebo under double-blind conditions . The daily number of hot flushes was recorded in a diary . Endometrial thickness was measured by means of transvaginal ultrasound ; the uterine , internal carotid , and middle cerebral arteries were evaluated using Doppler ultrasound . MAIN OUTCOME MEASURE(S ) The daily number of hot flushes , endometrial thickness , and arterial pulsatility index ( PI ) . RESULT ( S ) Both treatments led to a 40 % reduction in the number of hot flushes . Soy-derived isoflavones had no effect on endometrial thickness or the PI of the uterine and cerebral arteries . CONCLUSION ( S ) The daily administration of 72 mg of soy-derived isoflavones is no more effective than placebo in reducing hot flushes in postmenopausal women . It also has no effect on endometrial thickness or the PI of the uterine and cerebral arteries",
"Objective To evaluate the effect of 90 mg of daily genistein on markers of bone turnover and menopausal symptoms . Design This was a cross-over , placebo-controlled study involving 100 postmenopausal women . Subjects were r and omly assigned to daily genistein or placebo for 6 weeks and crossed over to the alternative preparation for the following 6 weeks . Pure genistein was processed and encapsulated in accordance with British Pharmacopoeia st and ards . Each capsule contained 90 mg of pure genistein while the placebo contained just the eccipients . Results In women with significant hot flushes ( score ( intensity × number ) ≥ 9 ) , genistein reduced symptoms by 30 % compared to baseline and the difference compared to placebo was statistically significant . No effect was observed on biochemical markers of bone turnover , possibly due to the short duration of each arm of the study . Genistein reduced osteocalcin , a marker of bone formation , by 3.6 % compared to baseline and 0.31 % compared to placebo ( p = 0.81 and 0.40 , respectively ) . Genistein increased cross-link telopeptide , a marker of bone resorption , by 1.8 % compared to baseline and 0.29 % compared to placebo ; both differences were not statistically significant ( p = 0.078 and 0.88 , respectively ) . Conclusion Pure genistein at a dose of 90 mg per day appears to reduce the number of hot flushes in postmenopausal women but the effect is mild",
"CONTEXT The timing of initiation of hormone therapy may influence its effect on cardiovascular disease . OBJECTIVE To explore whether the effects of hormone therapy on risk of cardiovascular disease vary by age or years since menopause began . DESIGN , SETTING , AND PARTICIPANTS Secondary analysis of the Women 's Health Initiative ( WHI ) r and omized controlled trials of hormone therapy in which 10,739 postmenopausal women who had undergone a hysterectomy were r and omized to conjugated equine estrogens ( CEE ) or placebo and 16,608 postmenopausal women who had not had a hysterectomy were r and omized to CEE plus medroxyprogesterone acetate ( CEE + MPA ) or placebo . Women aged 50 to 79 years were recruited to the study from 40 US clinical centers between September 1993 and October 1998 . MAIN OUTCOME MEASURES Statistical test for trend of the effect of hormone therapy on coronary heart disease ( CHD ) and stroke across categories of age and years since menopause in the combined trials . RESULTS In the combined trials , there were 396 cases of CHD and 327 cases of stroke in the hormone therapy group vs 370 [ corrected ] cases of CHD and 239 cases of stroke in the placebo group . For women with less than 10 years since menopause began , the hazard ratio ( HR ) for CHD was 0.76 ( 95 % confidence interval [ CI ] , 0.50 - 1.16 ) ; 10 to 19 years , 1.10 ( 95 % CI , 0.84 - 1.45 ) ; and 20 or more years , 1.28 ( 95 % CI , 1.03 - 1.58 ) ( P for trend = .02 ) . The estimated absolute excess risk for CHD for women within 10 years of menopause was -6 per 10,000 person-years ; for women 10 to 19 years since menopause began , 4 per 10,000 person-years ; and for women 20 or more years from menopause onset , 17 per 10,000 person-years . For the age group of 50 to 59 years , the HR for CHD was 0.93 ( 95 % CI , 0.65 - 1.33 ) and the absolute excess risk was -2 per 10,000 person-years ; 60 to 69 years , 0.98 ( 95 % CI , 0.79 - 1.21 ) and -1 per 10,000 person-years ; and 70 to 79 years , 1.26 ( 95 % CI , 1.00 - 1.59 ) and 19 per 10,000 person-years ( P for trend = .16 ) . Hormone therapy increased the risk of stroke ( HR , 1.32 ; 95 % CI , 1.12 - 1.56 ) . Risk did not vary significantly by age or time since menopause . There was a nonsignificant tendency for the effects of hormone therapy on total mortality to be more favorable in younger than older women ( HR of 0.70 for 50 - 59 years ; 1.05 for 60 - 69 years , and 1.14 for 70 - 79 years ; P for trend = .06 ) . CONCLUSIONS Women who initiated hormone therapy closer to menopause tended to have reduced CHD risk compared with the increase in CHD risk among women more distant from menopause , but this trend test did not meet our criterion for statistical significance . A similar nonsignificant trend was observed for total mortality but the risk of stroke was elevated regardless of years since menopause . These data should be considered in regard to the short-term treatment of menopausal symptoms . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00000611",
"Objective Pueraria lobata ( PL ) is used as a traditional Chinese herbal remedy for menopausal symptoms , as well as an ingredient in preparations for conditions affecting menopausal women , such as osteoporosis , coronary heart disease , and some hormone-dependent cancers . The scientific basis for its action may be its action as a phytoestrogen . Design To examine the effects of PL in comparison with hormone replacement therapy ( HRT ) on lipid profile , sex hormone levels , bone turnover markers , and indices of cognitive function . For the study , 127 community-living , postmenopausal women aged 50 to 65 years were r and omized to receive HRT ( n = 43 ) , PL ( equivalent to 100 mg isoflavone ; n = 45 ) , or no treatment ( n = 39 ) for 3 months . The following measurements were carried out at baseline and after 3 months for all participants : menopausal symptoms question naire ; neuropsychological tests covering memory , attention , motor speed , and word-finding ability ; quality of life ( SF36 ) ; lipid profile ; urinary deoxypyridinoline ; dietary phytoestrogen intake and urinary phytoestrogen ; estradiol ; follicle-stimulating hormone ; and luteinizing hormone . Results Only participants in the HRT group showed a mean reduction in cholesterol and low-density lipoprotein cholesterol that was significantly different from that of the control group . No significant changes in lipid profile or follicle-stimulating hormone and luteinizing hormone were observed in the PL group compared with the controls . However , both the HRT and PL groups showed an improvement in Mini-Mental State Examination score and attention span compared with the case of participants receiving no treatment . HRT and PL had different effects on cognitive function ; HRT improved delayed recall , whereas flexible thinking seemed improved in the PL group . Conclusions This study was unable to demonstrate a scientific basis for the use of PL for improving the health of postmenopausal women in general . However , the effect of PL on cognitive function deserves further study",
"OBJECTIVE To investigate the efficacy of soy isoflavone on climacteric symptoms in postmenopausal women . DESIGN In this double-blind , r and omized , placebo-controlled study , a total of 80 women ( mean age = 55.1 years ) , who reported 5 or more hot flush episodes per day , were r and omized to receive either 250 mg of st and ardized soy extract ( Glycine max AT ) a total of 100mg/day of isoflavone ( n = 40 ) or placebo ( n = 40 ) . Exclusion criteria included : contra-indication for hormone therapy ( HT ) , chronic gastrointestinal diseases , and users of HT within the preceding 6-months . For 10-months , climacteric symptoms were evaluated using a score card and the menopausal Kupperman index . Compliance and safety were also assessed . At baseline and the end of the study , lipid and hormonal profiles , as well as vaginal , mammographic and ultrasonographic parameters were measured . The t-test , Wilcoxon test and ANOVA were used in the statistical analysis . RESULTS At baseline , the mean number of hot flushes was 9.6 + /- 3.9 per day in the isoflavone group and 10.1+/-4.9 in the placebo group ( p>0.05 ) . After 10 months , there was a significant reduction in frequency of hot flushes among isoflavone users when compared to those on placebo ( 3.1 + /- 2.3 and 5.9 + /- 4.3 , respectively ) ( p Kupperman index mean values showed a significant reduction in both groups . However , soy isoflavone was significantly superior to placebo , in reducing hot flush severity ( 69.9 % and 33.7 % , respectively ) ( p Endometrial thickness , mammography , vaginal cytology , lipids and hormonal profile did not change in both groups . No serious adverse event related to isoflavone treatment was reported . CONCLUSIONS The soy isoflavone extract exerted favorable effects on vasomotor symptoms and good compliance , providing a safe and effective alternative therapeutic for postmenopausal women",
"We tested the hypothesis that postmenopausal women on a soy-supplemented diet show estrogenic responses . Ninety-seven postmenopausal women were r and omized to either a group that was provided with soy foods for 4 weeks or a control group that was instructed to eat as usual . Changes in urinary isoflavone concentrations served as a measure of compliance and phytoestrogen dose . Changes in serum FSH , LH , sex hormone binding globulin , and vaginal cytology were measured to assess estrogenic response . The percentage of vaginal superficial cells ( indicative of estrogenicity ) increased for 19 % of those eating the diet compared with 8 % of controls ( P = 0.06 when tested by ordinal logistic regression ) . FSH and LH did not decrease significantly with dietary supplementation as hypothesized , nor did sex hormone binding globulin increase . Little change occurred in endogenous estradiol concentration or body weight during the diet . Women with large increases in urinary isoflavone concentrations were not more likely to show estrogenic responses than were women with more modest increases . On the basis of published estimates of phytoestrogen potency , a 4-week , soy-supplemented diet was expected to have estrogenic effects on the liver and pituitary in postmenopausal women , but estrogenic effects were not seen . At most , there was a small estrogenic effect on vaginal cytology",
"PURPOSE Vasomotor symptoms , such as hot flashes and night sweats , in breast cancer survivors are often worsened by chemotherapy and tamoxifen , and /or the discontinuation of hormone replacement therapy at diagnosis . This study evaluated the acceptability and effectiveness of a soy beverage containing phytoestrogens as a treatment for hot flashes in postmenopausal women with breast cancer . METHODS A r and omized , placebo-controlled , double-blind clinical trial was conducted in postmenopausal women with moderate hot flashes who were previously treated for early-stage breast cancer . Women were stratified for tamoxifen use and r and omized to a soy beverage ( n = 59 ) containing 90 mg of isoflavones or to a placebo rice beverage ( n = 64 ) . Women recorded the number and severity of hot flashes daily with a daily menopause diary for 4 weeks at baseline and for 12 weeks while consuming 500 mL of a soy or placebo beverage . RESULTS There were no significant differences between the soy and placebo groups in the number of hot flashes or hot flash scores . However , presumably because of a strong placebo effect , both groups had significant reductions in hot flashes . Mild gastrointestinal side effects were experienced by both groups but occurred with greater frequency and severity with soy . The mean serum genistein concentration at 6 weeks was significantly higher in women who consumed soy ( 0.61 + /- 0.43 micromol/L ) compared with placebo ( 0.43 + /- 0.37 micromol/L ) ( P = .02 ) . Overall acceptability and compliance were high and similar in both groups . CONCLUSION The soy beverage did not alleviate hot flashes in women with breast cancer any more than did a placebo . Future research into other compounds is recommended to identify safe and effective therapies for hot flashes in breast cancer survivors",
"OBJECTIVE To evaluate the effects of a non-prescription red clover extract ( MF11 RCE , Melbrosin International , Vienna , Austria ) on selected sex hormones and endometrium in postmenopausal women . PATIENTS AND METHODS One-hundred and nine postmenopausal women with an age > or = 40 years were r and omly assigned to one of two groups either two capsules of MF11RCE ( 80 mg isoflavone ) per day for a 90 day period , or placebo of equal design . After a 7 day washout period , medication was crossed-over for another 90 days . RESULTS Combined evaluation demonstrated that supplementation with MF11RCE ( verum ) , in contrast to placebo , significantly increased plasma testosterone levels and decreased endometrial thickness . CONCLUSION MF11RCE exerts a moderate effect on testosterone levels in postmenopausal women , while estradiol levels remained unchanged . The observed reduction of endometrial thickness provides further support for a safe role for isoflavones in terms of endometrial hyperplasia",
"OBJECTIVE To evaluate the effect of a soy-rich diet on urogenital symptoms , vaginal health index , and vaginal cytology in perimenopausal and postmenopausal women . MATERIAL S AND METHODS Thirty-six perimenopausal and postmenopausal women ( mean age 52.5+/-5.1 years ) participated in a r and omized , cross-over trial with two 12-week diet periods and two 4-week washout periods before and between treatments . The study diet consisted of a control diet ( soy-free diet ) and an isocaloric soy-rich diet ( 25 g soy protein in various forms of soy food containing more than 50 mg/day of isoflavones substituted for an equivalent amount of animal protein ) . Subjects were assessed for urogenital symptoms , vaginal health index , vaginal pH and vaginal cytology . The single physician and the single cytopathologist were blinded with regard to onset , period and r and omization number . Statistical analyses were performed using paired t-test or Wilcoxon Signed Ranks Test , significance was set as P serum levels of daidzein and genistein during the soy-rich diet period . The symptoms of urge incontinence and vaginal dryness had significantly increased after 12-week of soy-free diet . All other urogenital symptoms did not change in both periods . The vaginal health index , the vaginal pH , the karyopyknotic index , and the maturation value were not significantly changed in both periods . CONCLUSION A soy-rich diet did not relieve the urogenital symptoms or restore the vaginal epithelium or improve the vaginal health in perimenopausal and postmenopausal Thai women",
"Objective : A phase I double-blind clinical trial was conducted to evaluate the effects of a high oral dose of soy isoflavones administered daily for 84 days to healthy postmenopausal women . Principal outcome measures included DNA damage , apoptosis , and changes indicative of estrogenic stimulation . Design : After eligibility and equol-producer status were determined , stratified r and omization was used to assign women to the isoflavone ( active ) or placebo group . Of the 30 women who completed the study , 18 were in the active group . DNA damage was assessed via COMET and apurinic/apyrimidinic site assays in lymphocytes . Apoptosis was evaluated via terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling and activated caspase-3 assays in lymphocytes . Estrogenic/antiestrogenic effects were assessed using a self-report question naire and by assaying for estrogen , follicle-stimulating hormone , luteinizing hormone , and sex hormone-binding globulin in blood . Results : In treated postmenopausal women , there was no indication that high doses of soy isoflavones caused DNA str and breakage , increased apurinic/apyrimidinic sites , or increased apoptosis in peripheral lymphocytes . There were no significant changes in mean values for estrogenic effects or other laboratory measurements . Very few adverse events occurred , and the only drug-related adverse events were mild or grade 1 in severity . Conclusions : Unconjugated soy isoflavones appear to be safe and well tolerated in healthy postmenopausal women at doses of 900 mg/day",
"Objectives : Equol , a metabolite of the isoflavone daidzein , is hypothesized to play a major role in the health benefits of soy . We examined the effect of a new S-equol supplement on menopausal symptoms and mood states . Design : We conducted a r and omized , double-blind , placebo-controlled trial with our new equol supplement for 12 weeks with 134 Japanese women ( aged 40 - 59 years ) . They were r and omly assigned to three groups : placebo ( n = 44 ) , 10 mg of equol per day ( EQ-1 ; n = 44 ) , and 10 mg of equol three times per day ( EQ-3 ; n = 46 ) . Habitual isoflavone intake was limited to 20 mg/d . Participants completed menopausal symptom and Profile of Mood States question naires at baseline and postintervention . Physical examination and blood and 24-hour urine collection were performed at baseline and postintervention . Results : At baseline , total menopausal symptom score varied by menopausal and equol producer status ( 34.3 % producers ) . A total of 127 participants ( 94.8 % ) completed the trial . No adverse effects were reported , except for a systemic rash in one EQ-3 woman . The anxiety scores of equol producers were lower than those of nonproducers ( P anxiety , somatic , and total scores . After the EQ-3 intervention , perimenopausal/postmenopausal equol nonproducers showed significant decreases from baseline in all menopausal symptom scores except depression ( P depression scores ( P Tension-Anxiety ( P Depression-Dejection ( P Fatigue ( P increases in Vigor ( P S-equol supplement improved mood-related symptoms in perimenopausal/postmenopausal equol nonproducers",
"OBJECTIVE To examine the change in menopausal symptoms and cardiovascular risk factors in response to 4 months of daily 100‐mg soy isoflavone in postmenopausal women . METHODS In this double‐blind , placebo‐controlled study , 80 women were r and omly assigned to isoflavone ( n = 40 ) and placebo ( n = 40 ) treatment . The menopausal Kupperman index was used to assess change in menopausal symptoms at baseline and after 4 months of treatment . Cardiovascular risk factors were assessed by evaluating plasma lipid levels , body mass index , blood pressure , and glucose levels in the participants . To examine the effects of this regime on endogenous hormone levels , follicle‐stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , and 17β‐estradiol were measured . Transvaginal sonography was performed to quantify endometrial thickness . RESULTS The data showed a decrease in menopausal symptoms ( P groups ) . Total cholesterol and low‐density lipoprotein decreased significantly in the isoflavone group compared with the baseline or placebo group ( P The isoflavone treatment appeared to have no effect on blood pressure , plasma glucose , and high‐density lipoprotein and triglyceride levels . CONCLUSION This study suggests that isoflavone 100‐mg regime treatment may be a safe and effective alternative therapy for menopausal symptoms and may offer a benefit to the cardiovascular system",
"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",
"OBJECTIVE The objective of this clinical trial was to examine the efficacy of a supplement containing natural S-(-)equol , a daidzein metabolite , in reducing menopausal symptoms . METHODS In this multicenter , double-blind placebo-controlled trial , 160 equol nonproducing , postmenopausal Japanese women who experienced at least 1 hot flush/day were r and omly assigned to consume 10 mg/day S-(-)equol ( n=77 women ) or placebo ( n=83 women ) for 12 weeks . Participants completed a st and ardized menopausal symptom checklist and rated five common menopause symptoms by a visual analog scale at baseline , week 12 , and week 18 ( 6-week postintervention ) . Physical , blood , and urine examinations were conducted . One hundred twenty-six women completed the study . RESULTS At baseline , daily hot flush frequency was 2.9±2.1 for the S-(-)equol group and 3.2±2.4 for the placebo group . After the 12-week intervention , the S-(-)equol group had a greater decrease from baseline in hot flush frequency compared with the placebo group ( -1.9±1.8/day , -58.7 % , vs. -1.0±2.0/day , -34.5 % , p=0.009 ) . The severity of hot flushes and neck or shoulder muscle stiffness significantly decreased in the S-(-)equol group compared with the placebo group . No changes in clinical parameters or serious adverse effects were reported . CONCLUSIONS This is the first trial to show beneficial effects of a 10-mg natural S-(-)equol supplement consumed daily for 12 weeks on major menopausal symptoms , specifically , hot flushes and neck or shoulder muscle stiffness , in postmenopausal Japanese women . This supplement offers a promising alternative for management of menopausal symptoms ",
"Objective : To evaluate in a 24-month , prospect i ve , r and omized , double-blind , placebo-controlled study whether pure administration of the phytoestrogen genistein ( 54 mg/d ) might reduce the number and severity of hot flushes in postmenopausal women , with no adverse effect on the endometrium and vagina . Methods : A total of 389 participants met the parent study criteria and were r and omly assigned to receive the phytoestrogen genistein ( n = 198 ) or placebo ( n = 191 ) . About 40 % of participants in both groups did not experience hot flushes , and the evaluation was performed in a subgroup of 236 participants ( genistein , n = 119 ; placebo , n = 117 ) . Reductions from the baseline in the frequency and severity of hot flushes were the principal criteria of efficacy . Endometrial thickness was evaluated by ultrasonography . The maturation value was also used to determine hormonal action on the vaginal cells . Results : There were no significant differences in vasomotor symptoms between groups at the baseline ( 4.4 ± 0.33 hot flushes per day in the genistein group and 4.2 ± 0.35 hot flushes per day in the control group ) . After 12 months of genistein therapy , there was a significant reduction ( −56.4 % ) in the mean number of hot flushes , with a significant difference compared with the control group . After 24 months , there was no further decrease in the number of hot flushes in both groups . No significant difference was found in mean endometrial thickness and the maturation value score between the two groups , either at the baseline or after 24 months . Conclusions : The phytoestrogen genistein has been shown to be effective on vasomotor symptoms without an adverse effect on the endometrium and vagina , but after the first year , there was no further improvement in the decrease in hot flushes",
"OBJECTIVE To investigate the efficacy-safety balance of the isopropanolic extract of Actaea ( = Cimicifuga ) racemosa ( iCR , Remifemin ) in comparison with tibolone in Chinese women with climacteric complaints . METHOD The r and omized , double-blind , controlled 3-month study in 5 centers of 3 cities in China enrolled 244 menopausal patients aged 40 - 60 years and with a Kupperman Menopause Index (KMI)>or=15 . The participants were assigned to either iCR corresponding to 40 mg crude drug/day ( N=122 ) or tibolone 2.5mg/day ( N=122 ) orally . The primary endpoint was the combination of the Mann-Whitney values ( MWV ) of the KMI and the frequency of adverse events ( benefit-risk balance ) at end of treatment ( MWV>0.5 shows superiority ; MWV>0.36 shows non-inferiority ) . RESULTS KMI decreased from 24.7+/-6.1 to 11.2+/-6.2 and 7.7+/-5.8 ( iCR ) and to 11.2+/-7.2 and 7.5+/-6.8 ( tibolone ) at 4 and 12 weeks . This remarkable and clinical ly relevant improvement was similar in both treatment groups ( MWV=0.47 ; 95 % CI=0.39 - 0.54 ; p(non-inferiority)=0.002 ) showing statistical significant non-inferiority of iCR to tibolone . The KMI-responder rate was similar in both groups ( 84 % and 85 % ) . The safety evaluation showed for both groups a good safety and tolerability profile , however , there is a significant lower incidence of adverse events ( p vaginal bleeding in contrast to tibolone ( 17 cases ) . Breast and abdominal pain as well as leukorrhea was mostly observed in the tibolone group ( p=0.015 , p=0.008 , p=0.002 ) . No serious adverse event was observed in the iCR-group , however , two occurred in the tibolone-group . The benefit-risk balance for iCR was significantly ( p=0.01 ) superior to tibolone ( MWV=0.56 ; 95 % confidence interval [ 0.51 - 0.62 ] ) . CONCLUSION The efficacy of iCR ( medicinal product Remifemin ) is as good as tibolone for the treatment of climacteric complaints , even for moderate to severe symptoms , whereby iCR is clearly superior regarding the safety profile . This iCR containing medicinal product is an excellent option for treatment of climacteric complaints which has now for the first time been verified in Asian women",
"Objective : To compare the effects of daily ingestion of soy flour ( S ) , ground flaxseed ( F ) , or wheat flour ( W ) muffins , on quality of life and hot flash frequency and severity in postmenopausal women . Design : This was a double-blind , r and omized , controlled , intention-to-treat trial . Ninety-nine women , 1 to 8 years after menopause , ingested muffins with 25 g of flaxseed ( 50 mg of lignans ) , 25 g of soy ( 42 mg of isoflavones ) , or wheat ( control ) daily for 16 weeks . Subjects completed the Menopause-specific Quality of Life instrument monthly along with daily hot flash frequency and severity diaries . Compliance measures included a 3-day food diary and urinary isoflavone and lignan analyses at weeks 0 and 16 and returned muffin counts monthly . Results : Eighty-seven women ( 28 , ground flaxseed muffins ; 31 , soy flour muffins ; and 28 , wheat flour muffins ) completed the trial . Multivariate analysis of variance of all quality -of-life domains yielded an insignificant treatment × time interaction ( F46,122 = 0.92 , P = 0.62 ) but a significant time main effect ( P quality -of-life domains and hot flash measures except severity . Hot flashes were less severe with flaxseed ( P = 0.001 ) compared to placebo ; however , the group × by time interaction was not significant . Phytoestrogen excretion analysis showed treatment group exposure as allocated and no contamination . Conclusion : Neither dietary flaxseed nor soy flour significantly affected menopause-specific quality of life or hot flash symptoms in this study",
"This study is a double-blind , r and omized , placebo-controlled trial to assess the effects of high amounts of phytoestrogens on bone mineral density , cardiovascular diseases , cognitive function , performance in activities of daily life and well being . Participants were healthy postmenopausal women , aged 60 - 75 years . Between March and September 2000 , 202 women were recruited , and , after completion of the baseline measurements , r and omized to either soy protein , containing 99 mg naturally occurring isoflavones or placebo ( milk protein ) daily for 1 year . Analysis of the endpoints will be based on the difference between baseline measurements and measurements at the end of the intervention period with group allocation as independent variable",
"OBJECTIVE To investigate the effect of soy protein supplementation with known levels of phytoestrogens on cardiovascular disease risk factors and menopausal symptoms in perimenopausal women . METHODS A r and omized , double-blind crossover trial was conducted in 51 women consuming isocaloric supplements containing 20 g of complex carbohydrates ( comparison diet ) , 20 g of soy protein containing 34 mg of phytoestrogens given in a single dose , and 20 g of soy protein containing 34 mg of phytoestrogens split into two doses . Women were r and omly assigned to one of the three diets for 6-week periods and subsequently were r and omized to the remaining two interventions to determine whether differences existed between the treatment diets for cardiovascular disease risk factors , menopausal symptoms , adherence , and potential adverse effects . RESULTS Significant declines in total cholesterol ( 6 % lower ) and low density lipoprotein cholesterol ( 7 % lower ) were observed in both soy diets compared with the carbohydrate placebo diet . A significant decline in diastolic blood pressure ( 5 mm Hg lower ) was noted in the twice-daily soy diet , compared with the placebo diet . Although nonsignificant effects were noted for a number of measures of quality of life , a significant improvement was observed for the severity of vasomotor symptoms and for hypoestrogenic symptoms in the twice-daily group compared with the placebo group . No significant effects were noted for triglycerides , high density lipoprotein cholesterol or frequency of menopausal symptoms . Adherence was excellent in all groups . CONCLUSIONS Soy supplementation in the diet of nonhypercholesterolemic , nonhypertensive , perimenopausal women result ed in significant improvements in lipid and lipoprotein levels , blood pressure , and perceived severity of vasomotor symptoms . These data corroborate the potential importance of soy supplementation in reducing chronic disease risk in Western population",
"OBJECTIVE To evaluate the effects of treatment with Trifolium pratense on climacteric symptoms and sexual satisfaction in postmenopausal women . METHODS This is a prospect i ve , r and omized , double-blind , placebo-controlled study . Initially , 120 women aged 45 - 65 years with menopausal symptoms , more than 12-month amenorrhea and no treatment in the past six months were selected . The participants were then divided into two groups : TG – receiving 40 mg Trifolium pratense , 1 capsule/day ; PG – receiving placebo capsules containing lactose ( control ) , 1 capsule/day . The duration of treatment was 12 months . The patients underwent clinical and laboratory evaluation before treatment and at four , eight and 12 months of treatment . The Kupperman Menopausal Index and the Golombok Rust Inventory of Sexual Satisfaction ( GRISS ) were used . At the end of the study , each group comprised 50 patients . RESULTS According to the Kupperman Menopausal Index , there was significant improvement in menopausal symptoms after four months of treatment , especially in relation to hot flashes , when compared to baseline data in both groups . However , no significant differences were observed between groups . There was no improvement in sexual satisfaction after treatment . CONCLUSION A 12-month treatment with a daily dose of 40 mg Trifolium pratense did not yield a significant improvement in menopausal symptoms and sexual satisfaction ",
"Venous thromboembolism , including thrombosis of the deep veins of the legs and embolism to the pulmonary arteries , is a serious and potentially fatal event . Venous thromboembolism is uncommon in the general population , occurring in about 1 to 4 per 1000 adults annually ( 1 , 2 ) . However , the risk is increased in persons with previous venous thromboembolism ( 3 ) , recent surgical procedures ( 4 , 5 ) , immobilization , fracture of a lower extremity ( 4 , 6 , 7 ) , cancer ( 4 , 6 , 7 ) , and inherited coagulation disorders ( 8 , 9 ) . Use of oral contraceptive pills increases risk for venous thromboembolism ( 1 , 2 ) . This increased risk is thought to be due to estrogen and to be dose related ( 3 , 4 ) . The biological potency of the estrogens generally used in postmenopausal hormone therapy is about one-fourth to one-fifth that of the estrogens in modern oral contraceptives . Until recently , there has been little evidence that low-dose estrogen therapy is associated with increased risk for venous thromboembolism ( 5 - 8 ) . Recent observational studies have suggested that postmenopausal hormone therapy causes a twofold to fourfold increase in risk for idiopathic deep venous thrombosis and pulmonary embolism ( 9 - 13 ) . However , these findings may be biased if women taking estrogen are more likely to be evaluated for nonspecific symptoms suggestive of venous thromboembolism . The Heart and Estrogen/progestin Replacement Study ( HERS ) was a r and omized , blinded , placebo-controlled trial of the effect of daily conjugated equine estrogen , 0.625 mg , plus medroxyprogesterone acetate , 2.5 mg , on the rate of new coronary events in 2763 postmenopausal women with established coronary heart disease ( 14 ) . One of the specified secondary outcomes of this trial was venous thromboembolism . An increased risk for venous thromboembolism among women assigned to hormone therapy was noted by the HERS Data and Safety Monitoring Board . The Board instructed the HERS investigators to inform participants and the scientific community of this risk and to institute measures to reduce risk . At a mean follow-up of 3.3 years , the HERS investigators notified participants to discontinue study medication in situations associated with increased risk for venous thromboembolism , such as surgery , hospitalization , fracture , and cancer , and published a letter noting the increased risk ( 15 ) . This report presents the full analysis of the findings . Methods Participants in HERS were postmenopausal women younger than 80 years of age who had coronary disease ( myocardial infa rct ion , coronary artery bypass surgery , percutaneous coronary revascularization , or angiographic evidence of at least 50 % narrowing of one or more major coronary arteries ) and had not had a hysterectomy . Women were excluded if their coronary event occurred within 6 months of r and omization ; they had used hormone therapy within 3 months of r and omization ; they had a history or baseline findings suggestive of venous thromboembolism , breast cancer , or endometrial cancer ; or they had uncontrolled hypertension , diabetes , or other life-threatening diseases ( 16 ) . The protocol was approved by the institutional review board at each of the 20 HERS clinical centers , and all participants provided written informed consent . Participants were r and omly assigned to take one tablet daily of conjugated equine estrogen , 0.625 mg , plus medroxyprogesterone acetate , 2.5 mg , or placebo that was identical in appearance . R and omization was stratified by clinical center and performed in blocks of 4 . To prevent unblinding of clinical center staff , HERS participants reported breast discomfort and vaginal bleeding directly to gynecology staff , who were located separately from the clinical center staff , did not communicate with clinical center personnel about breast or gynecologic problems , and did not participate in ascertainment of outcomes . Follow-up visits to the clinical centers occurred at 4-month intervals . Coronary events ( nonfatal myocardial infa rct ion and coronary death ) were the primary outcome of the trial ( 14 ) . At each visit , clinic staff asked participants if they had been told by a physician that they had a blood clot in the legs or lungs . Women were also asked whether they had been hospitalized , and records were review ed to determine whether venous thromboembolism had occurred . Women were not routinely asked about symptoms of venous thrombosis , such as lower-extremity edema . Diagnosis of deep venous thrombosis required documentation of thrombosis of the popliteal or more proximal veins of the legs by venography , impedance plethysmography , or sonography . Pulmonary embolism required documentation by a nuclear lung scan that suggested a high probability of pulmonary embolism ( segmental or larger perfusion defect with ventilation mismatch ) or by pulmonary angiography that revealed a constant intraluminal filling defect on multiple films . Suspected venous thromboembolism was adjudicated independently and without knowledge of treatment assignment by two physicians at the HERS Coordinating Center , located at the University of California , San Francisco ; disagreements were resolved by consensus . Persons who analyzed data were also blinded to participants ' treatment status . Data were collected on events that occurred during the trial that might be predictors of venous thromboembolism , including fractures , nonfatal myocardial infa rct ion , congestive heart failure , stroke , and transient ischemic attack ( 16 ) . Venous thromboembolism was classified as idiopathic in women who did not have concomitant cancer , nonfatal myocardial infa rct ion , congestive heart failure , or stroke and did not have a fracture , inpatient surgery , or hospitalization in the 3 months before the venous thromboembolic event . In the primary analysis , an unadjusted Cox proportional-hazards model for time to first event was used to compare the rate of venous thromboembolism among women assigned to hormone therapy with the rate among women assigned to placebo . The primary analysis was intention-to-treat ; participants were categorized according to treatment assignment regardless of compliance . Participants who were lost to follow-up ( 33 women in the hormone therapy group and 36 in the placebo group ) were censored at the last date at which they were known to be alive without venous thromboembolism ; vital status was known for all women at the end of the trial . We also performed an as-treated analysis , in which inclusion in the risk sets was limited to women in both treatment groups whose average compliance with therapy during the trial ( measured by pill count ) was at least 80 % . Relative hazards were also estimated by year since r and omization ( women with events in earlier years were censored ) , and continuous trend in the log relative hazard was examined in a companion model . We repeated the main analyses separately for idiopathic and nonidiopathic venous thromboembolism . Potential risk factors for venous thromboembolism were first examined by using univariate proportional hazards models adjusted for treatment assignment . In these models , postr and omization events and medication use were represented by time-dependent indicators , which reverted to zero 90 days after fracture , surgery , or hospitalization or when therapy was discontinued . Variables associated with venous thromboembolism for which the associated P value was less than 0.2 in univariate analyses were considered for inclusion in multivariate models and retained in the model if the P value remained less than 0.2 . Statistical analyses were performed by using SAS software , version 6.12 ( SAS Institute , Inc. , Cary , North Carolina ) . Results The 20 HERS centers enrolled 2763 women between February 1993 and September 1994 ; of these , 1380 were assigned to the hormone therapy group and 1383 to the placebo group . Participants ranged in age from 44 to 79 years ( mean age [ SD ] , 67 7 years ) . At baseline , the treatment groups did not differ significantly ( Table 1 ) . Table 1 . Baseline Characteristics of HERS Participants At the end of the first year , 82 % of women in the hormone therapy group and 91 % in the placebo group reported taking study medication ; by the end of the third year , these proportions had decreased to 75 % and 81 % , respectively . Cumulative incidence curves for all venous thromboembolic events ( deep venous thrombosis and pulmonary embolism ) are shown in the Figure . During 10 985 woman-years of follow-up , 47 women experienced a venous thromboembolic event : 34 in the hormone-treated group ( 6.2 per 1000 woman-years ) and 13 in the placebo group ( 2.3 per 1000 woman-years ) ( relative hazard , 2.7 [ 95 % CI , 1.4 to 5.0 ] [ P = 0.003 ] ; excess risk , 3.9 per 1000 woman-years [ CI , 1.4 to 6.4 per 1000 woman-years ] ; number needed to treat for harm , 256 [ CI , 157 to 692 ] ) . The relative hazard of venous thromboembolism did not differ significantly among the 20 clinical centers . Figure . Kaplan-Meier estimates of the cumulative incidence of venous thromboembolic events ( top ) , deep venous thrombosis ( middle ) , and pulmonary embolism ( bottom ) . More women in the hormone therapy group than in the placebo group experienced deep venous thrombosis ( 25 compared with 9 ; relative hazard , 2.8 [ CI , 1.3 to 6.0 ] ; P = 0.008 ) and pulmonary embolism ( 11 compared with 4 ; relative hazard , 2.8 [ CI , 0.9 to 8.7 ] ; P = 0.08 ) ( Table 2 ) . Two women , both in the hormone therapy group , died of pulmonary embolism . The relative hazard was increased for idiopathic ( relative hazard , 3.1 [ CI , 0.8 to 11.3 ] ) and nonidiopathic venous thromboembolic events ( relative hazard , 2.5 [ CI , 1.2 to 5.3 ] ) . The overall results were unchanged in an as-treated analysis that was limited to women who reported taking more than 80 % of their assigned study medication ( relative hazard , 3.2 [ CI , 1.5 to 6.9 ] ; P = 0.003 ) . Table 2 . Venous Thrombolic Events by Treatment Group and Year of R and omization Table 2 shows relative hazards for venous thromboembolism by year since r and omization . The number of episodes of pulmonary",
"Objective : The onset of climacteric symptoms ( hot flashes and night sweats ) is the primary reason for perimenopausal women to start hormone therapy . The association of a lower incidence of postmenopausal symptoms with high intake of soybeans in Asian women suggests that phytoestrogens are an alternative to estrogen therapy . The main effective compounds in soybean are isoflavones , which have a higher binding affinity to estrogen receptor & bgr ; than to estrogen receptor & agr;. The aim of present study was to evaluate the effects of isoflavone treatment in postmenopausal women . Design : This was a double-blind prospect i ve study . Sixty healthy postmenopausal women were r and omly assigned by computer into two groups to receive 60 mg isoflavones or placebo daily for 3 months . Before and after treatment , climacteric symptoms were recorded ; serum was collected to measure the levels of lipoprotein lipids , estradiol , and follicle-stimulating hormone ; and biopsy specimens from endometrium and breast were analyzed to investigate the expression level of steroid receptors and proliferation . Endometrial thickness was measured by ultrasound . Results : Fifty-one women finished the 12-week study . In women receiving 60 mg isoflavones daily , hot flashes and night sweats were reduced by 57 % and 43 % , respectively . The treatment did not change the levels of circulating estradiol or follicle-stimulating hormone . Immunohistochemical staining of endometrial and breast biopsy specimens revealed that isoflavones did not affect expression levels of steroid receptors ; estrogen receptors & agr ; , & bgr ; , and & bgr;cx ; progesterone receptors A and B ; or the proliferation marker Ki67 . No side effects on body weight or lipoprotein lipids were observed . Conclusions : This short-term prospect i ve study implies that isoflavones could be used to relieve acute menopausal symptoms",
"OBJECTIVES To investigate the effect on hot flushes of a soy isoflavone extract alone ( Study A ) and with the addition of a supplement of polyunsaturated fatty acids , PUFAs ( Study B ) . METHODS Subjects were postmenopausal women ( 29 in Study A , 28 in Study B ) with more than five troublesome hot flushes per day . Both studies were double-blind r and omized placebo-controlled trials with cross-over design , of 24-week duration . After a 2-week observation period , they were r and omized to receive two capsules per day providing 60 mg of isoflavones or placebo for 12 weeks ; thereafter , women who had taken isoflavones were given placebo for a second 12-week period , and vice-versa . Women in the Study B were given also two capsules per day containing a PUFA supplement for the entire 24-week test period . RESULTS Both studies showed the isoflavone extract to have no greater efficacy on hot flushes than the placebo . During the 24 weeks of the Study B there was a progressive and highly significant reduction in the number of hot flushes , independent of whether the women had begun with isoflavones or with placebo . CONCLUSION In these two trials the isoflavone extract did not show greater efficacy on the hot flushes than the placebo . The reduction of hot flushes observed in the Study B might be due to the PUFA supplement . PUFAs , particularly Omega ( Omega ) 3-fatty acids , could reduce hot flushes through their influence on neuronal membranes and /or the modulation of the neurotransmitter function and the serotoninergic system . Studies specifically design ed to document the action of PUFAs on hot flushes would be welcome",
"We previously reported that a high soya diet improved memory and frontal lobe function in young volunteers , and since soya isoflavones are agonists at oestrogen receptors , they may improve these functions in postmenopausal women . Thirty-three postmenopausal women ( 50 - 65 years ) not receiving conventional hormone replacement therapy ( HRT ) were r and omly allocated in a double-blind parallel study to receive a soya supplement ( 60 mg total isoflavone equivalents/day ) or placebo for 12 weeks . They received a battery of cognitive tests and completed analogue rating scales of mood and sleepiness , and a menopausal symptoms question naire before the start of treatment and then after 12 weeks of treatment . Those receiving the isoflavone supplement showed significantly greater improvements in recall of pictures and in a sustained attention task . The groups did not differ in their ability to learn rules , but the isoflavone supplement group showed significantly greater improvements in learning rule reversals . They also showed significantly greater improvement in a planning task . There was no effect of treatment on menopausal symptoms , self-ratings of mood , bodily symptoms or sleepiness . Thus , significant cognitive improvements in postmenopausal women can be gained from 12 weeks of consumption of a supplement containing soya isoflavones that are independent of any changes in menopausal symptoms , mood or sleepiness",
"Objective Preliminary data suggest that flaxseed , a rich source of dietary lignans , may be a potentially effective treatment of hot flashes . A phase III , r and omized , placebo , controlled trial was conducted to evaluate the efficacy of flaxseed in reducing hot flashes . Methods Postmenopausal women with or without breast cancer were r and omly assigned to a flaxseed bar ( providing 410 mg of lignans ) for 6 weeks versus a placebo bar . Participants completed daily , prospect i ve , hot flash diaries during the baseline week , and then ate one study bar per day for 6 weeks while recording their daily hot flashes . The intraparticipant difference in hot flash activity between baseline and the last treatment week was the primary endpoint . Adverse effects were evaluated through a self-report and the Common Terminology Criteria assessment . Results A total of 188 women were enrolled in this trial . The mean hot flash score was reduced 4.9 in the flaxseed group and 3.5 in the placebo group ( P = 0.29 ) . In both groups , slightly more than a third of the women received a 50 % reduction in their hot flash score . Only one adverse effect was significantly different between groups , grade 1 pruritus , which was more common in the placebo group ( 8 % vs 1 % ) . Both groups reported abdominal distension , flatulence , diarrhea , and nausea . Adherence and ability to detect treatment assignment did not differ between groups . Conclusions The results of this trial do not support the use of 410 mg of lignans for the reduction of hot flashes . The bars were fairly well tolerated , with both groups reporting gastrointestinal effects , probably due to the fiber content",
"Background . The unexpected results of the Women 's Health Initiative study have decreased the use of conventional hormone therapy ( HT ) , changing physicians ' and patients ' attitudes towards HT and increasing their interest in alternative options . Objective . The present study aim ed to evaluate the effect of isoflavones contained in red clover extracts ( Trifolium pratense ) on menopausal symptoms , lipids and vaginal cytology in menopausal women . Methods . Sixty postmenopausal women aged > 40 years , non-users of HT , with Kupperman index score ⩾15 , were double-blindly r and omized to receive either a commercially available red clover isoflavone supplement ( 80 mg/day ) or placebo for 90 days . Subsequently , after a 7-day washout period , subjects switched to receive the opposite treatment for a further 90 days . Kupperman index score was determined and fasting blood and vaginal cytologic sampling performed at baseline , 90 and 180 days . Results . Fifty-three women ( 88.3 % ) completed the trial . Mean age was 51.3 ± 3.5 years , 69.7 % of the women were aged 50 years or more . There was no significant effect on body mass index , weight or blood pressure after either treatment phase . Baseline Kupperman index score decreased significantly after each treatment phase , with the decrease more pronounced after the isoflavone phase ( baseline : 27.2 ± 7.7 ; after isoflavone : 5.9 ± 3.9 ; after placebo : 20.9 ± 5.3 , p supplementation significantly decreased the rate of menopausal symptoms and had a positive effect on vaginal cytology as expressed by improvement in karyopyknotic , cornification and basal cell maturation indices . Mean total cholesterol , low-density lipoprotein-cholesterol and triglyceride levels also decreased ; however , only the latter was significantly lower compared with placebo . Conclusions . Compared with placebo , red clover isoflavone supplementation in postmenopausal women significantly decreased menopausal symptoms and had a positive effect on vaginal cytology and triglyceride levels ",
"Objective . To evaluate the effect of red clover isoflavone supplementation over vasomotor and overall menopausal symptoms in postmenopausal women . Methods . One hundred and nine postmenopausal women aged 40 or more were assigned to r and omly receive either two daily capsules of the active compound ( 80 mg red clover isoflavones , Group A ) or placebo of equal appearance ( Group B ) for a 90-day period . After a washout period of 7 days , medication was crossed over and taken for 90 days more . Daily hot flush and night sweat frequency and overall menopausal symptom intensity ( Kupperman Index ) were measured at baseline , 90 , 97 and 187 days . Results . Daily hot flush/night sweat frequency and Kupperman Index values were similar in both studied groups at baseline . All indices significantly decreased after red clover phase in Group A , corresponding , respectively to a 73.5 % , 72.2 % and 75.4 % average decrement . These decrements were significantly higher than those observed for Group B after placebo phase ( 8.2 % , 0.9 % and 6.7 % respectively ) . In Group A , after washout and placebo phases all values significantly increased . In Group B , all indices remained similar after placebo and washout phases , however significantly dropping after red clover treatment . These values were also significantly lower than those observed in Group A after placebo phase . No side effects were encountered after treatment with the active compound or placebo . Conclusion . Red clover isoflavone supplementation was more effective than placebo in reducing daily vasomotor frequency and overall menopausal intensity in postmenopausal women",
"BACKGROUND The isoflavones genistein , daidzein , and their glycosides , found in high concentrations in soybeans and soy-protein foods , may have beneficial effects in the prevention or treatment of many hormone-dependent diseases . Because these bioactive phyto-oestrogens possess a wide range of hormonal and non-hormonal activities , it has been suggested that adverse effects may occur in infants fed soy-based formulas . METHODS To evaluate the extent of infant exposure to phyto-oestrogens from soy formula , the isoflavone composition of 25 r and omly selected sample s from five major br and s of commercially available soy-based infant formulas were analysed , and the plasma concentrations of genistein and daidzein , and the intestinally derived metabolite , equol , were compared in 4-month-old infants fed exclusively soy-based infant formula ( n = 7 ) , cow-milk formula ( n = 7 ) , or human breast-milk ( n = 7 ) . FINDINGS All of the soy formulas contained mainly glycosides of genistein and daidzein , and the total isoflavone content was similar among the five formulas analysed and was related to the proportion of soy isolate used in their manufacture . From the concentrations of isoflavones in these formulas ( means 32 - 47 micrograms/mL ) , the typical daily volume of milk consumed , and average bodyweight , a 4-month-old infant fed soy formula would be exposed to 28 - 47 per day , or about 4.5 - 8.0 mg/kg bodyweight per day , of total isoflavones . Mean ( SD ) plasma concentrations of genistein and daidzein in the seven infants fed soy-based formulas were 684 ( 443 ) ng/mL and 295 ( 60 ) ng/mL , respectively , which was significantly greater ( p Circulating concentrations of isoflavones in the seven infants fed soy-based formula were 13000 - 22000 times higher than plasma oestradiol concentrations in early life , and may be sufficient to exert biological effects , whereas the contribution of isoflavones from breast-milk and cow-milk is negligible",
"OBJECTIVE To test the hypothesis that increasing the intake of isoflavones by dietary supplementation may produce a therapeutic effect in reducing the incidence and severity of hot flushes in menopausal women . METHODS Fifty-one postmenopausal women were r and omized to placebo and active ( one tablet per day of a 40-mg isoflavone supplement ) groups in a cross-over design trial . After a 1-week run-in period , subjects were commenced on a 12-week period of treatment ( active or placebo ) , followed by a 1-month placebo wash-out period , then crossed over to the alternative treatment regimen for a further 14 weeks . Symptom diaries were maintained throughout the trial and at the start and end of treatment . Plasma sex hormone binding globulin ( SHBG ) assay , full blood count , biochemical profiles , vaginal swabs and vaginal ultrasound scans were performed and isoflavones determined in 24-h urine collection s by high-pressure liquid chromatography ( HPLC ) analysis . RESULTS There was no significant difference between active and placebo groups in the reduction in hot flushes between start and finish time-points . Analysis performed on interim data time-points revealed a substantially greater reduction in flushing in the active group than placebo at 4 and 8 weeks after commencement of treatment , but this was not statistically significant . There were no significant differences between groups for Greene scores or in SHBG levels , hematological or biochemical parameters and vaginal swab or ultrasound findings . The combined values for all subjects , regardless of treatment group , revealed a strong negative correlation between the level of urinary isoflavone excretion and the incidence of hot flushes . CONCLUSIONS These data do not indicate a therapeutic benefit from dietary supplementation with isoflavones in women experiencing menopausal symptoms , but do indicate that the apparent placebo effect in many studies of menopausal symptoms may be attributable to dietary sources of isoflavones . The study also demonstrates that 3 months of isoflavone supplementation did not cause adverse events or endometrial changes",
"OBJECTIVE To evaluate the effect of soy isoflavones and melatonin in relieving menopausal symptoms . METHODS Double-blind , multicenter , r and omized trial performed according to a 2 x 2 factorial design . Treatment groups : ( 1 ) soy isoflavones+melatonin ; ( 2 ) soy isoflavones alone ; ( 3 ) melatonin alone ; ( 4 ) placebo . 80 mg of soy isoflavones , 3 mg of pure melatonin or placebo were supplemented to participants for 3 months . Severity of menopausal symptoms was recorded at baseline and after 3 months using the Greene Climacteric Scale . RESULTS 388 consecutive women were screened : not eligible 98 , refused informed consent 28 . R and omized 262 and analyzed 232 ; twelve women withdrew because of adverse events . Median percent differences between basal and final scores were 39 % in the isoflavones + melatonin group , 38 % in the isoflavones alone group , 26 % in the melatonin alone group and 38 % in the placebo group . Placebo response was much higher than planned , making it meaningless to perform any statistical test . With regard to somatic and vasomotor symptoms , outcome was similar among the four groups , whereas improvement of psychological symptoms was higher in the isoflavones+melatonin group than in the other three . CONCLUSIONS Present data do not show any advantage of isoflavones or melatonin over placebo for the relief of menopausal symptoms . However , the effect in psychological symptoms in the isoflavones + melatonin group should be further investigated",
"Objective : The aim of this study was to evaluate the safety and efficacy of black cohosh and red clover compared with placebo for the relief of menopausal vasomotor symptoms . Methods : This study was a r and omized , four-arm , double-blind clinical trial of st and ardized black cohosh , red clover , placebo , and 0.625 mg conjugated equine estrogens plus 2.5 mg medroxyprogesterone acetate ( CEE/MPA ; n = 89 ) . Primary outcome measures were reduction in vasomotor symptoms ( hot flashes and night sweats ) by black cohosh and red clover compared with placebo ; secondary outcomes included safety evaluation , reduction of somatic symptoms , relief of sexual dysfunction , and overall improvement in quality of life . Results : Reductions in number of vasomotor symptoms after a 12-month intervention were as follows : black cohosh ( 34 % ) , red clover ( 57 % ) , placebo ( 63 % ) , and CEE/MPA ( 94 % ) , with only CEE/MPA differing significantly from placebo . Black cohosh and red clover did not significantly reduce the frequency of vasomotor symptoms as compared with placebo . Secondary measures indicated that both botanicals were safe as administered . In general , there were no improvements in other menopausal symptoms . Conclusions : Compared with placebo , black cohosh and red clover did not reduce the number of vasomotor symptoms . Safety monitoring indicated that chemically and biologically st and ardized extracts of black cohosh and red clover were safe during daily administration for 12 months",
"OBJECTIVE To evaluate the effects of isoflavones on vasomotor symptoms and blood lipids in postmenopausal women with contraindication for conventional hormone replacement therapy ( HRT ) . METHODS This prospect i ve , double-blind and placebo-controlled study included 50 postmenopausal women r and omly divided into two groups : 25 women on soy germ isoflavones ( 60 mg per day , capsules ) and 25 women on placebo . Inclusion criteria included : non-vegetarian , non-asian women whose last menstruation date d at least 12 months prior to the beginning of the study , with FSH > 40 mIU/ml , hot flushes and contraindication for HRT , not using tamoxifen or antibiotic and no disease of the gastrointestinal tract . For 6 months , the Kupperman menopausal index ( KMI ) , the vaginal cytological maturation value ( MV ) and both hormonal and lipid profiles were assessed . The t-test and analysis of variance ( ANOVA ) were employed to compare the two groups . RESULTS In both groups , a decreased KI rate was observed . However , isoflavone was significantly superior to placebo in reducing hot flushes ( 44 % versus 10 % , respectively ) ( P estradiol levels with unchanged FSH , LH , and vaginal cytology , and a reduction of 11.8 % in LDL and an increase of 27.3 % in HDL ( P MV was observed after 6 months ( P Soy germ isoflavone exerted favorable effects on vasomotor symptoms and lipid profile , showing itself to be an interesting alternative therapy for the postmenopausal women with contraindication for conventional HRT",
"Objective : To evaluate vaginal , endometrial , and reproductive hormone effects of three herbal regimens compared with placebo and hormone therapy ( HT ) . Design : This was a 1-year , r and omized , double-blind , placebo-controlled trial of 351 women , ages 45 to 55 , with two or more vasomotor symptoms per day . Women were r and omly assigned to ( 1 ) black cohosh , ( 2 ) a multibotanical containing black cohosh , ( 3 ) the same multibotanical plus dietary soy counseling , ( 4 ) HT , or ( 5 ) placebo . Women were ineligible if they had used HT in the previous 3 months or menopausal herbal therapies in the previous month . Data on vaginal cytology and dryness were collected ( at baseline and 3 and 12 mo ) . Daily menstrual diaries were maintained by 313 women with a uterus , and abnormal bleeding was evaluated . Serum estradiol , follicle-stimulating hormone , luteinizing hormone , and steroid hormone-binding globulin were assessed ( baseline and 12 mo ) among 133 postmenopausal women . Gynecologic outcomes of the five groups were compared . Results : The five groups did not vary in baseline vaginal cytology profiles , vaginal dryness , menstrual cyclicity , or hormone profiles . The HT group had a lower percentage of parabasal cells and vaginal dryness than the placebo group at 3 and 12 months ( P Abnormal bleeding occurred in 53 of 313 ( 16.9 % ) women . There were no differences in frequency of abnormal bleeding between any of the herbal and placebo groups , whereas women in the HT group had a greater risk than those in the placebo group ( P HT significantly decreased follicle-stimulating hormone and increased estradiol ; none of the herbal interventions showed significant effects on any outcomes at any time point . Conclusion : Black cohosh , used alone or as part of a multibotanical product with or without soy dietary changes , had no effects on vaginal epithelium , endometrium , or reproductive hormones",
"Objective : To evaluate the effect of Pueraria mirifica on lipid profiles and biochemical markers of bone turnover rates in healthy postmenopausal women and to evaluate the safety of Pueraria mirifica on endometrium ; breast tissue ; and hematologic , hepatic , and renal systems . Design : This was a r and omized , double-blind , placebo-controlled study in a university hospital of healthy postmenopausal women aged 45 to 60 years old . Women were enrolled voluntarily and r and omly received 20 , 30 , or 50 mg Pueraria mirifica in capsules or identical placebo once daily for 24 weeks . Outcome measures were lipid profiles , bone-specific alkaline phosphatase level , endometrial thickness , endometrial histology , breast ultrasonography , complete blood count , liver function test , and renal function test . Results : After 24 weeks of treatment , 71 women were evaluated . Of the 71 women , 51 r and omly received varying doses of Pueraria mirifica and 20 received placebo . Pueraria mirifica and placebo significantly increased triglyceride levels by 15 % from baseline levels ( P The Pueraria mirifica group showed a significant decrease in bone-specific alkaline phosphatase levels after 24 weeks of treatment compared with the placebo group ; from 0.22 ± 0.18 U/L to 0.13 ± 0.01 U/L in the Pueraria mirifica group and from 0.20 ± 0.10 U/L to 0.20 ± 0.14 U/L in the placebo group . Endometrial thickness did not change after treatment in both groups ( P > 0.05 ) . No endometrial proliferation or hyperplasia was reported after 24 weeks of treatment in both groups . There were no significant differences in adverse effects on breast tissue , complete blood count , and liver and renal function tests between the Pueraria mirifica and placebo groups in this study . Conclusion : Pueraria mirifica at a dose of 20 , 30 , and 50 mg/d for a 24-week period demonstrated an estrogen-like effect on bone turnover rate . Pueraria mirifica did not demonstrate an estrogen-like effect on endometrial thickness and endometrial histology . Mild adverse effects occurred after Pueraria mirifica and placebo treatment",
"OBJECTIVES To examine the efficacy of a hop extract ( st and ardized at 100mug 8-prenylnaringenin per day ) for relief of menopausal discomforts . METHODS A 16-week r and omized , double-blind , placebo-controlled , cross-over study was conducted with 36 menopausal women . The participants were r and omly allocated to either placebo or active treatment ( hop extract ) for a period of eight weeks after which treatments were switched for another eight weeks . The Kupperman Index ( KI ) , the Menopause Rating Scale ( MRS ) and a multifactorial Visual Analogue Scale ( VAS ) were assessed at baseline , and after eight and sixteen weeks . RESULTS After 8 weeks , both active treatment and placebo significantly improved all outcome measures when compared to baseline with somewhat higher average reductions for placebo than for the active treatment . After 16 weeks only the active treatment after placebo further reduced all outcome measures , whereas placebo after active treatment result ed in an increase for all outcome measures . Although , the overall estimates of treatment efficacy ( active treatment-placebo ) based on linear mixed models do not show a significant effect , time-specific estimates of treatment efficacy indicate significant reductions for KI ( P = 0.02 ) and VAS ( P = 0.03 ) and a marginally significant reduction ( P = 0.06 ) for MRS after 16 weeks . CONCLUSIONS Whereas the first treatment period result ed in similar reductions in menopausal discomforts in both treatment groups , results from the second treatment period suggest superiority of the st and ardized hop extract over placebo . Thus , phytoestrogen preparations containing this st and ardized hop extract may provide an interesting alternative to women seeking relief of mild vasomotor symptoms ",
"Objective . To determine the efficacy and safety of the herbal formula Phyto-Female Complex ( SupHerb , Netanya , Israel ; ingredients : st and ardized extracts of black cohosh , dong quai , milk thistle , red clover , American ginseng , chaste-tree berry ) for the relief of menopausal symptoms . Methods . A r and omized , double-blind , placebo-controlled trial in 50 healthy pre and postmenopausal women , aged 44–65 years , to whom oral Phyto-Female Complex or matched placebo was prescribed twice daily for 3 months . A structured question naire on the frequency and intensity of menopausal symptoms was administered weekly from one week before throughout the 3-month treatment period , followed by biochemical tests , breast check , and transvaginal ultrasonography . Results . The women receiving Phyto-Female Complex reported a significantly superior mean reduction in menopausal symptoms than the placebo group . The effect of treatment improvements in menopausal symptoms increased over time ; by 3 months there was a 73 % decrease in hot flushes and a 69 % reduction of night sweats , accompanied by a decrease in their intensity and a significant benefit in terms of sleep quality . Hot flushes ceased completely in 47 % of women in the study group compared with only 19 % in the placebo group . There were no changes in findings on vaginal ultrasonography or levels of relevant hormones ( estradiol , follicle-stimulating hormone ) , liver enzymes or thyroid-stimulating hormone in either group . Conclusion . Phyto-Female Complex is safe and effective for the relief of hot flushes and sleep disturbances in pre- and postmenopausal women , at least for 3 months ' use",
"Objective : The aim of this study was to determine the effect of DRIs on hot flash symptoms in menopausal women . Design : This was a r and omized , double-blind , placebo-controlled trial of menopausal women , aged 38 to 60 years , who experienced 4 to 14 hot flashes per day . After a 1-week run-in period , a total of 190 menopausal women were r and omized to receive a placebo or 40 or 60 mg/day of a DRI for 12 weeks . The primary outcome was the mean changes from baseline to week 12 in the frequency of hot flashes recorded in the participant diary . The secondary outcomes included changes in quality of life and hormonal profiles . Results : A total of 147 women ( 77 % ) completed the study . It was found that 40 and 60 mg of DRI improved hot flash frequency and severity equally . At 8 weeks hot flash frequency was reduced by 43 % in the 40-mg DRI group and by 41 % in the 60-mg DRI group , compared with 32 % in the placebo group ( P = not significant vs placebo ) . The corresponding numbers for 12 weeks were 52 % , 51 % , and 39 % , respectively ( P = 0.07 and 0.09 vs placebo ) . When comparing the two treatment groups with the placebo group , there were significant reductions in mean daily hot flash frequency . The supplement ( either 40 or 60 mg ) reduced hot flash frequency by 43 % at 8 weeks ( P = 0.1 ) and 52 % at 12 weeks ( P = 0.048 ) but did not cause any significant changes in endogenous sex hormones or thyroid hormones . Menopausal quality of life improved in all three groups , although there were no statistically significant differences between groups . Conclusions : DRI supplementation may be an effective and acceptable alternative to hormone treatment for menopausal hot flashes",
"OBJECTIVES To investigate the effectiveness and safety of a red clover isoflavone dietary supplement ( Promensil , Novogen Ltd. , Australia ) versus placebo on the change in hot flush frequency in postmenopausal women . METHODS In this r and omized , double blind , placebo-controlled trial 30 women with more than 12 months amenorrhoea and experiencing more than five flushes per day were enrolled . All received single blind placebo tablets for 4 weeks and were subsequently r and omized to either placebo or 80 mg isoflavones for a further 12 weeks . Efficacy was measured by the decrease in number of hot flushes per day and changes in Greene Climacteric Scale Score . RESULTS During the first 4 weeks of placebo the frequency of hot flushes decreased by 16 % . During the subsequent double blind phase , a further , statistically significant decrease of 44 % was seen in isoflavones group ( P Greene score decreased in the active group by 13 % and remained unchanged in the placebo group . CONCLUSION In this study , treatment with 80 mg isoflavones ( Promensil ) per day result ed in a significant reduction in hot flushes from baseline . At the end of the study there was a significant decrease in hot flushes of 44 % between the active and placebo group , demonstrating the effectiveness of Promensil in the management of hot flushes",
"The present study aim ed to evaluate the short-term effects of a combination of isoflavones , lignans and Cimicifuga racemosa on acute climacteric-related symptoms in postmenopausal women in a double-blind , r and omized , placebo-controlled trial performed at the menopause clinic of our department . Eighty healthy postmenopausal women were r and omly assigned to two treatment groups – one receiving the combination ( group A , n = 40 ) , the other receiving calcium supplements ( group B , n = 40 ) – for three cycles of 28 days . Climacteric-related symptoms were evaluated by the Kupperman index ( KI ) at baseline and after the three cycles of treatment . At baseline no significant difference was detected in KI between groups A and B ; however , after three cycles of treatment , KI was significantly ( p of isoflavones , lignans and C. racemosa already reduces acute climacteric symptoms in postmenopausal women after 3 months of treatment . This prompt effect is probably due to the different pharmacokinetic properties of isoflavones and lignans ; isoflavones are absorbed faster than lignans , while lignans are removed later . The combination of these molecules can guarantee a better reduction of postmenopausal symptoms over a 24-h period",
"Objective To assess the effects of a red clover-derived isoflavone extract on the Ki-67 proliferative marker of endometrial biopsies in 45-to 50-year-old perimenopausal women . We hypothesized that we would be able to detect a decrease in the Ki-67 proliferative index during the late follicular phase after a 3-month course of ∼50 mg red clover isoflavones . Isoflavones have been found to have some antiestrogenic effects , and an antiproliferative effect during the perimenopausal period may be especially useful owing to the excessive endometrial proliferation often characteristic of this period . Design In a double-blind , r and omized , controlled study , 30 women between the ages of 45 and 50 years consented to an endometrial biopsy before and after a 3-month course of either placebo or active isoflavone extract . The biopsies were timed as close as possible to days 7–11 of the menstrual cycle , and simultaneous measurements of transvaginal endometrial thickness , uterine artery Doppler , hormone profiles , lipids , and bone markers were performed . Results Of 30 women , 2 did not return for a second biopsy , and a third had an unsuccessful second biopsy . Four subjects were excluded from the Intention to Treat analysis because they did not have a menstrual bleed within the time frame of the study ( 3 subjects ) or were tested on day 13 instead of between days 7 and 11 of the cycle ( 1 subject ) . There was no change in the Ki-67 proliferation index after treatment in either group . Eight subjects in the placebo group and eight in the P-07 group had proliferative endometrial biopsies that were synchronized with estradiol levels at baseline and post-treatment , and analysis of these subjects revealed no detectable change in the relationship between estradiol levels and Ki-67 with treatment in either group . There was no change in fasting lipids , bone markers , uterine Doppler resistance , or pulsatility index . Conclusion In this small pilot study , we did not find , using immunohistochemical quantification of the Ki-67 antigen , that red clover isoflavones had an antiproliferative effect in the endometrium . Small sample size , examination of a relatively short interval in the menstrual cycle , and isoflavone formulation may have contributed to our lack of findings ; however , we believe that the issue of isoflavones and their possible antiproliferative effect is deserving of further study . A simpler physiological model with less hormonal variability , such as healthy , recently menopausal women on predetermined doses of estrogen , may prove to be more informative",
"OBJECTIVE To determine the effects of soy-derived isoflavones on vaginal epithelium and the endometrium . DESIGN Double-blind , r and omized , placebo-controlled crossover trial . SETTING Outpatient clinic of a university hospital . PATIENT(S ) Sixty-four postmenopausal women with a history of breast cancer . INTERVENTION(S ) The women took ( in a r and omized order ) 114 mg of isolated isoflavonoids or placebo in tablets daily for 3 months ; the treatment regimens were crossed over after a 2-month washout period . The subjects were studied before and on the last day of each treatment period . MAIN OUTCOME MEASURE(S ) Vaginal dryness , maturation index ( MI ) of vaginal epithelium , endometrial thickness , histology , and expression of estrogen ( E ) and progesterone ( P ) receptors and the proliferation marker Ki-67 in the endometrium . RESULT ( S ) Isolated isoflavones did not relieve vaginal dryness . Maturation index values remained unchanged during the isoflavone regimen , but decreased during the placebo regimen . No changes were found in any of the variables measured in the endometrium . CONCLUSION ( S ) Daily administration of 114 mg of isolated isoflavones for 3 months had no effect on the subjective perception of vaginal dryness or on objective findings in the vagina or endometrium . This implies safety with regard to the endometrium",
"OBJECTIVE To evaluate the efficacy of synthetic genistein for reducing the frequency and severity of hot flushes . STUDY DESIGN A 12 week r and omized double-blind , placebo-controlled study in which 84 postmenopausal women received placebo or a single 30 mg dose of synthetic genistein . Outcome measures primary : percentage change in the number of daily hot flushes from pre-treatment to week 12 . Secondary : duration and severity of daily hot flushes , Greene Climacteric Scale score , serum follicle stimulating hormone ( FSH ) , 17β-estradiol and endometrial thickness . RESULTS Genistein supplemented subjects completing at least 4 weeks on trial ( n=40 ) demonstrated a 51 % reduction ( 9.4 - 4.7/day ) in the number of hot flushes by week 12 compared to a 27 % reduction in the placebo group ( 9.9 - 7.1/day ) ( p=0.026 ) . Subjects in the genistein group also reported significantly fewer hot flushes per day ( p=0.010 ) and a decrease in total duration of hot flushes per day ( p=0.009 ) at week 12 versus placebo . Subjects on genistein ( n=32 ) completing 12 weeks on trial demonstrated a 51 % reduction ( 9.7 - 4.7/day ) in the number of hot flushes by week 12 ( p=0.049 ) compared to 30 % reduction in the placebo group ( 9.8 - 7.0/day ) and had fewer hot flushes per day and a decrease in total duration of hot flushes per day at week 12 compared to placebo ( p=0.020 and p=0.017 , respectively ) . There were no differences between groups in Greene Climacteric Scale , FSH , 17β-estradiol , endometrial thickness or adverse events . CONCLUSIONS The current study provides the first evidence that a single daily dose of 30 mg of synthetic genistein reduces hot flush frequency and duration ",
"BACKGROUND A traditional asiatic phytoestrogen-rich diet is associated with a lower incidence of estrogen-dependent cancers and clinical consequences of postmenopausal estrogen deficiency . First Wilcox in 1990 , showed an increase of the vaginal cell maturation with phytoestrogens on postmenopausal women , but this has not been confirmed in some subsequent studies . METHODS In this study , we analyzed the effects of a 6-month soy-rich diet on the vaginal epithelium of asymptomatic postmenopausal women in a r and omized clinical trial . 187 women were recruited for the study and divided into three groups : a phytoestrogen rich diet group ; a hormonal replacement group , and a control group . A vaginal sample for hormonal cytology was taken before and at the end of the study , and sent unnamed to a cytologist . RESULTS The karyopycnotic index ( KI ) increased significantly in the diet group and in the HRT group but not in the control group . The maturation value ( MV ) had an identical trend to the KI . CONCLUSION We conclude that a soy rich diet is efficacious in increasing the maturation indices of vaginal cells . This effect could be a useful marker of the efficacy of a dietary intervention with phytoestrogen rich foods , and should be considered during preventive interventions against menopausal effects and vaginal atrophy",
"Objective To investigate the efficacy of dietary soy proteins containing differing amounts of isoflavones on the number and severity of vasomotor symptoms ( hot flashes and night sweats ) in peri- and postmenopausal women . Design A double-masked , r and omized , controlled , clinical trial was conducted . A total of 241 community-dwelling women reporting vasomotor symptoms at baseline were r and omized into one of three groups . In all groups , participants consumed a daily supplement containing 25 g of soy protein and were r and omly assigned to one of three groups : ( a ) isoflavone extracted soy protein ( control ) , ( b ) soy protein with a medium dose of isoflavones ( 42 mg/day ) , or ( c ) soy protein with a higher dose of isoflavones ( 58 mg/day ) . The primary outcome measure in this trial was change in reported vasomotor symptoms . Results A reduction in the number and severity of vasomotor symptoms was observed in all three treatment groups . No significant differences in the number and severity of vasomotor symptoms were observed among the high isoflavone , middle isoflavone , or control groups . The lack of a between-treatment group effect was observed even after stratified by number of baseline symptoms and use of traditional hormone replacement therapy . Conclusions These data suggest that soy protein containing 42 or 58 mg of isoflavones is no more effective than isoflavone-extracted soy protein for improving the number and severity of vasomotor symptoms in peri- and postmenopausal women",
"Subgroup analyses can pose serious multiplicity concerns . By testing enough subgroups , a false-positive result will probably emerge by chance alone . Investigators might undertake many analyses but only report the significant effects , distorting the medical literature . In general , we discourage subgroup analyses . However , if they are necessary , research ers should do statistical tests of interaction , rather than analyse every separate subgroup . Investigators can not avoid interim analyses when data monitoring is indicated . However , repeatedly testing at every interim raises multiplicity concerns , and not accounting for multiplicity escalates the false-positive error . Statistical stopping methods must be used . The O'Brien-Fleming and Peto group sequential stopping methods are easily implemented and preserve the intended alpha level and power . Both adopt stringent criteria ( low nominal p values ) during the interim analyses . Implementing a trial under these stopping rules resembles a conventional trial , with the exception that it can be terminated early should a treatment prove greatly superior . Investigators and readers , however , need to grasp that the estimated treatment effects are prone to exaggeration , a r and om high , with early stopping",
"STUDY OBJECTIVE To describe the impact of the results of the Women 's Health Initiative ( WHI ) on hormone replacement therapy ( HRT ) discontinuation rates . DESIGN Retrospective chart review . SETTING University-based family medicine clinic . SUBJECTS Ninety-eight postmenopausal women ( aged 50 - 79 yrs ) with an intact uterus who were receiving HRT . MEASUREMENTS AND MAIN RESULTS Two study periods were defined : pre-WHI ( July 9 , 2001-January 9 , 2002 ) and post-WHI ( July 9 , 2002-January 9 , 2003 ) . Patient demographics and HRT discontinuation or persistence data were collected . Seven women were eligible for only for pre-WHI , 13 only for post-WHI , and 78 were eligible for both groups based on HRT use during both time periods . Forty-two of the 78 women were r and omized to the pre-WHI group and 36 to the post-WHI group to yield equal groups of 49 each . No significant demographic differences existed between the groups . Time-to-event analysis revealed an increased probability of HRT discontinuation after WHI versus before WHI ( log-rank test , p of 85 women taking HRT 1 year before WHI were followed for 18 months . Discontinuation rates were 8 % ( 7 of 85 patients ) during the 12 months before WHI and 38 % ( 30 of 78 ) during the 6 months after WHI , with 80 % ( 24 of 30 ) of these patients discontinuing within 3 months . CONCLUSION Increased HRT discontinuation was temporally associated with release of WHI data , which implies that highly publicized , negative outcomes data can quickly influence pharmacotherapy decisions",
"Previous studies have reported a 20—30 % reduction of climacteric symptoms with placebo and additional reductions of 10—20 % using soy preparations providing 30—104 mg/day of isoflavones . However most studies were based on data from postmenopausal women . Their hormone status was quite different when compared to women undergoing menopause transition ( MT ) . A single center prospect i ve and r and omized study was conducted to investigate the effect of insoflavone supplements with different doses in climacteric symptoms in women undergoing MT . After initial screening 48 women were recruited and assigned to two groups 35 mg and 70 mg groups with treatment duration of 6 weeks . Isoflavone supplements were prepared from soy extract in 325 mg capsules containing 17.5 mg of isoflavones per capsule ( Phyto Soya Arkopharma Laboratories Pharmaceutique France ) . Modified Greene ’s climacteric scale with three additional symptoms ( frequency incontinence and vaginal dryness ) was used to assess climacteric symptoms . ( excerpt",
"Objective The purpose of this study was to assess the effect of soy isoflavone supplementation on quality of life in postmenopausal women . Methods A multicenter , r and omized , double-blind , placebo-controlled 24-month trial was conducted to assess the effect of 80 or 120 mg of daily aglycone hypocotyl soy isoflavone supplementation on quality of life in 403 postmenopausal women using a vali date d Menopause-Specific Quality of Life question naire . Results Menopause-Specific Quality of Life domain scores at 1 year and 2 years were similar to baseline . There were no differences in domain scores among treatment groups . Conclusions Soy isoflavone supplementation offers no benefit to quality of life in postmenopausal women",
"Objective To compare the effects of raloxifene and soy phytoestrogens on endothelial function in healthy , postmenopausal women . Design R and omized , double-blind , placebo-controlled , cross-over trial . Subjects ( n = 22 ; mean age 58.5 years ) underwent endothelial function testing at baseline and following 6 weeks of daily raloxifene 60 mg , soy phytoestrogens 55 mg , and placebo in r and om sequence with intervening 6-week wash-out periods . Endothelial function was assessed as flow-mediated vasodilatation ( FMD ) of the brachial artery using high-resolution ultrasound ; digital flux was measured with laser Doppler velocimetry . Results Baseline ( pretreatment ) FMD was almost within normal range at 9.6 % ( ±6.4 ) . FMD did not change from baseline within any treatment group , and no between-group differences were detected . FMD values following treatment with raloxifene , soy , and placebo were 10.3 % ( ±12.3 ) , 8.3 % ( ±7.7 ) , and 9.5 % ( ±4.4 ) , respectively . Area under curve ratios showed no treatment differences for digital velocimetry . Conclusions In this study , neither raloxifene nor soy enhanced endothelial function in postmenopausal women . However , the cohort had relatively normal endothelial function at baseline . Further study is required to determine if particular subgroups of postmenopausal women derive vascular benefit from the use of selective estrogen receptor modulators or soy phytoestrogens",
"In order to evaluate the efficacy of soya isoflavones ( genistein and daidzein ) in the treatment of the principal menopausal disorders , a double blind r and omized study was performed on a sample of 50 women ( with an average age of 53.3 + /- 3.1 years ) with Climacteric syndrome referred to the I Clinica Ostetrica e Ginecologica , Policlinico Umberto I , Roma . The research protocol involved the r and om subdivision of the enrolled sample into two groups of 25 women , group 1 ( with an average age of 53.3 + /- 3.5 years , and an average menopausal age of 51.6 + /- 1.8 years ) and group 2 ( with an average age of 53.1 + /- 2.9 years , and an average menopausal age of 51.3 + /- 1.2 years ) , who were to receive treatment for three months with the product being studied and with a placebo . After the three-month period , as an additional check , the group initially treated with the placebo would move to the phyto-oestrogens and viceversa . All of the patients were subjected to a series of clinical and instrumental examinations and were asked to fill in a question naire concerning their complaints , at the start , at halfway ( third month ) and at the end ( sixth month ) of the trial . The results of the evaluation of the question naires performed on the 47 patients who had completed the trial showed , in the first three months , an improvement in the symptoms ( hot flushes ) in 11 patients treated with phyto-oestrogens against 6 patients from the group that received only the placebo . In the second three-month period the hot flushes reappeared in 4 of the 11 patients who had previously seen improvements and had then passed to the placebo . In contrast , the group that passed to the phyto-oestrogens , after treatment with the placebo , experienced the disappearance of hot flushes in 11 women , including the 6 who had already improved in the first three months . There was no significant reduction in anxiety , insomnia or vaginal dryness . None of the enrolled patients indicated complaints linked to the treatment . It can be concluded that the use of a product based on phyto-oestrogens , such as the one experimented , can lead to a significant reduction in some of the disorders linked with the menopause , especially hot flushes",
"The aim of this study was to evaluate the efficacy of a food supplement combination based on isoflavones and berberine ( ISB ) in the treatment of menopausal symptoms and dyslipidaemia . Isoflavones are extracted from soy and absorbed in the body after being activated by lactobacillus . Berberine , extracted from the plant Berberis aristata , lowers plasma cholesterol and triglycerides ( TG ) by increasing low-density lipoprotein ( LDL ) receptors and reducing hepatic synthesis of TG . One hundred twenty women with a mean age of 54.8 ± 0.6 years were enrolled and r and omized to treatment with ISB ( estromineral lipid [ EL ] = 60 cases ) or calcium and vitamin D3 ( CaD = 60 cases ) . Menopausal symptoms , plasma cholesterol , and TG were evaluated at baseline , and after 4 and 12 weeks . EL treatment significantly lowered plasma total cholesterol ( −13.5 % ± 0.7 vs −0.2 % ± 0.5 ) , LDL cholesterol ( −12.4 % ± 1.5 vs + 0.8 % ± 0.7 ) and TG ( −18.9 % ± 2.5 vs −1.3 % ± 1.2 ) and improved menopausal symptoms compared with CaD treatment . Safety parameters were unchanged during the study . The combination of berberine and isoflavones was effective in lowering cardiovascular ( CV ) risk factors in menopausal women with moderate dyslipidaemia and in improving their quality of life ",
"Otolaryngol Head Neck Surg 1988;114 : 887 - 90 . 9 Jacobson JT , Morehouse CR . A comparison of auditory brain stem response and behavioural screening in high risk and normal newborn infants . Ear Hear 1984;5:247 - 53 . 10 Mahoney TM , Eichwald JG . The ups and \" downs \" of high risk screening : the Utah statewide program . Seminars in Hearing 1987;8:155 - 63 . 11 Stein L , Clark S , Kraus N. The hearing impaired infant : patterns of identification and habilitation . Ear Hear 1983;4:232 - 6 . 12 Elssmann SF , Matkin ND , Sabo MP . Early identification of sensorineural hearing impairment . The HearingJournal 1987;40:13 - 7 . 13 American Speech-Hearing- Language Association . Guidelines for the identification of hearing impairment in at risk infants age birth to 6 months . ASHA 1988;30:61 - 4 . 14 Hendricks-Munoz KD , Walton JP . Hearing loss in infants with persistent fetal circulation . Pediatrics 1988;81:650 - 6 . 15 Naulty CM , Weiss IP , Herer GR . Progressive sensorineural hearing loss in survivors of persistent fetal circulation . Ear Hear 1986;7:74 - 7 . 16 Hall DMB , ed . Screening for hearing impairment . In : Health for all children . Oxford : Oxford Medical Publications , 1989:59 - 67",
"Objective : To investigate the efficacy and safety of the special extract ERr 731 from the roots of Rheum rhaponticum compared to placebo in perimenopausal women with climacteric complaints . Design : A multicenter , prospect i ve , r and omized , double-blind , placebo-controlled , clinical trial in which 109 women with climacteric complaints received either one enteric-coated tablet of ERr 731 ( n = 54 ) or placebo ( n = 55 ) daily for 12 weeks . Primary outcome criterion for efficacy was the change in Menopause Rating Scale II ( MRS II ) total score after 12 weeks . Other efficacy assessment s analyzed number and severity of hot flushes , menopause-specific quality of life , number of bleeding/spotting days , and treatment outcome . Results : By 12 weeks , the MRS II total score and each MRS II symptom significantly decreased in the ERr 731 group compared to the placebo group ( P 731 also significantly decreased the number and severity of hot flushes ( P overall menopause-specific quality of life was significantly better in women treated with ERr 731 compared with placebo ( P ERr 731 group , and ERr 731 was better tolerated than placebo . There were no differences in gynecological findings including endometrial biopsies , bleeding , weight , blood pressure , pulse , and laboratory safety parameters between the treatment groups . No adverse events were classified as being related to the investigational medication . Conclusions : Compared to placebo , ERr 731 significantly reduces the occurrence and severity of climacteric complaints in perimenopause . It is also safe and well tolerated",
"OBJECTIVE To establish the changes in lipid and hormone levels , as well as in symptoms , after topical application of a cream with phytoestrogens in postmenopausal women . METHODS 30 postmenopausal women were studied . At baseline and 1 month after the beginning of treatment , levels of FSH , estradiol , estrone , testosterone , and rostenedione , dehydroepi and rosterone , total cholesterol , HDL-C , LDL-C , and triglycerides were measured . Climacteric symptoms were evaluated with a modified Kupperman 's index ( KI ) . The subjects received a cream with phytoestrogens ( n = 15 ) or placebo ( cold cream ) ( n = 15 ) in a r and omized , double-blind manner . Statistically significant differences were determined by Student 's t test . RESULTS No differences were found in hormones , lipids , or in KI between the groups . When comparing each group separately , only a significant decrease in KI was found , in both groups , at the end of the treatment . CONCLUSIONS This cream with phytoestrogens had an effect only in climacteric symptoms , but similar to the placebo . The lack of effect in the other variables was probably due to the administration route , or to a lack of effect of this product",
"OBJECTIVE To evaluate whether ovarian stromal blood flow velocity after pituitary suppression is predictive of ovarian response and the outcome of IVF treatment in patients with normal basal serum FSH levels and to compare the predictive value of this test with age , early follicular phase serum FSH level , E2 level , and FSH : LH ratio . DESIGN Prospect i ve observational study of women undergoing IVF treatment . SETTING A tertiary referral center for assisted reproduction . PATIENT(S ) Eighty-eight women who received the long buserelin acetate treatment protocol . INTERVENTION(S ) Transvaginal color and pulsed Doppler measurement of the ovarian stromal peak systolic velocity ( PSV ) after pituitary suppression and measurement of the basal serum FSH level , E2 level , and FSH : LH ratio . MAIN OUTCOME MEASURE(S ) Number of mature oocytes retrieved and pregnancy rate . RESULT ( S ) Ovarian stromal PSV was the most important single independent predictor of ovarian response in patients with a normal basal serum FSH level , when compared with age , basal FSH level , E2 level , or FSH : LH ratio . Patients in group 2 ( PSV > or = 10 cm/s ) had a significantly higher median number of mature oocytes retrieved ( 11 versus 5.5 ) and a higher clinical pregnancy rate ( 35.3 % versus 11.3 % ) than patients in group 1 ( PSV < 10 cm/s ) , even after controlling for age . CONCLUSION ( S ) Ovarian stromal blood flow velocity , after pituitary suppression is confirmed , is predictive of ovarian responsiveness and the outcome of IVF treatment",
"OBJECTIVES To compare the effects of daily ingestion of dietary soy supplementation , low-dose hormone therapy ( HT ) and placebo on psychological , somatic and urogenital symptoms in postmenopausal women . STUDY DESIGN A double-blind , r and omized , controlled trial . Sixty healthy , symptomatic , postmenopausal women of 40 - 60 years of age were allocated to use dietary soy supplementation ( containing 90 mg of isoflavone ) or HT ( 1 mg estradiol and 0.5 mg norethisterone acetate ) or placebo . MAIN OUTCOME MEASURES the Menopause Rating Scale ( MRS ) was used to assess menopausal symptoms at baseline and after 16 weeks of treatment . Intention-to-treat analyses were performed using the chi-square test , Fisher 's exact test , the Kruskal-Wallis non-parametric test and analysis of variance ( ANOVA ) . RESULTS No statistically significant differences were found between the groups with respect to baseline clinical and sociodemographic characteristics . The psychological , somatic and urogenital symptoms analyzed in the MRS improved during treatment in all the groups , except for urogenital symptoms in the placebo group in which no significant changes were detected . Comparison between groups revealed a statistically significant improvement in somatic symptoms ( hot flashes and muscle pain ) in the users of HT ( -45.6 % ) and dietary soy supplementation ( -49.8 % ) . Urogenital symptoms ( vaginal dryness ) improved significantly in HT users ( -38.6 % ) and in users of the dietary soy supplementation ( -31.2 % ) . There was no statistically significant difference between the groups with respect to overall MRS score or to scores obtained in the psychological symptoms subscale . CONCLUSION Dietary soy supplementation may constitute an effective alternative therapy for somatic and urogenital symptoms of the menopause",
"OBJECTIVE The aim of this study was to evaluate the effects of isoflavone on the climacteric symptoms ( Kupperman Menopausal index ) , vaginal pH , vaginal cytology ( vaginal maturation index ) and endometrium ( evaluated by ultrasound and biopsy ) in postmenopausal women . METHODS It was a single-center , 6-month , r and omized , double-blind , estrogen-controlled trial . Seventy-nine women were r and omly assigned to one of the two treatment groups : isoflavone ( n=40 ) : 300 mg of the st and ardized soy extract with a medium dose of 120 mg isoflavones/day as glycoside and aglycone ( 60 mg twice a day ) , or estrogen ( n=39 ) : one capsule of 0.625 mg conjugated equine estrogens and other capsule with glucose 0.625 mg ( placebo ) . RESULTS After treatment , there was a decrease in the symptomatology in both estrogen and isoflavone groups . There was a significant decrease in vaginal pH , an increase in superficial vaginal cells and endometrium proliferation after 3 and 6 months of treatment in the estrogen group , but no differences were observed in the isoflavone group for these variables . CONCLUSIONS We concluded that the daily st and ardized soy extract with 120 mg isoflavones ' effect on symptoms was similar to that from estrogen . Soy isoflavone has no effect on endometrium and vaginal mucosa during the treatment",
"Objective To assess the effects of an oral soy isoflavone extract ( Phytosoya ® ) on endometrium and breast in postmenopausal women treated for 3 years . Methods A total of 395 postmenopausal women were included in this international prospect i ve , open-label study . The number of patients who completed the 3-year study was 197 . The women were treated for 3 years with a specific , st and ardized soy isoflavone extract ( total 70 mg/day ) . Endometrial biopsy , transvaginal ultrasonography and mammography were performed before and after 3 years of treatment . Results No case of hyperplasia/cancer was diagnosed among the 192 interpretable biopsies at 3 years . Only one case of simple hyperplasia was diagnosed among 197 post-baseline interpretable biopsies . The endometrial safety of this extract has been demonstrated ( point estimate 0.5 % ) . There was no statistically significant change in endometrial thickness after 3 years ( 98.4 % inactive or atrophic and 0.3 % proliferative endometrium at 1 year ) . Mammography results showed no notable change from baseline . No patient in any set developed an ACR classification of 4 or 5 after 3 years of treatment . The global safety was rated as either ‘ excellent ’ or ‘ good ’ by 99.1 % of investigators and 99.0 % of patients after 3 years of treatment . The adverse events were as follows : eight patients had metrorrhagia and seven patients had at least one breast adverse event : three patients had ‘ breast pain ’ , two patients reported ‘ breast tenderness ’ and two patients had ‘ hypertrophic breast ’ ( most of them were possibly treatment-related ) . Conclusions As no case of hyperplasia was diagnosed among the 301 interpretable biopsies at 1 year and there was only one case of simple hyperplasia in the 197 post-baseline biopsies at 3 years , the endometrial safety of this extract has been demonstrated . Furthermore , as demonstrated by the lack of change in endometrial thickness associated with the histologic results , we suggest that this extract does not exert a mitogenic effect on the endometrium . These results suggest that daily administration of 70 mg of a specific , st and ardized isoflavone extract for 3 years could be a safe treatment for both endometrium and breast",
"Soy isoflavones have been hypothesized to exert hormonal effects in postmenopausal women . To test this hypothesis , we studied the effects of three soy powders containing different levels of isoflavones in 18 postmenopausal women . Isoflavones were consumed relative to bodyweight [ control : 0.11 + /- 0.01 ; low isoflavone ( low-iso ) : 1.00 + /- 0.01 ; high isoflavone ( high-iso ) : 2.00 + /- 0.02 mg/kg/day ] for 93 days each in a r and omized crossover design . Blood was collected on day 1 of the study ( baseline ) and days 36 - 38 , 64 - 66 , and 92 - 94 of each diet period , for analysis of estrogens , and rogens , gonadotropins , sex hormone binding globulin ( SHBG ) , prolactin , insulin , cortisol , and thyroid hormones . Vaginal cytology specimens were obtained at baseline and at the end of each diet period , and endometrial biopsies were performed at baseline and at the end of the high-iso diet period , to provide additional measures of estrogen action . Overall , compared with the control diet , the effects of the low-iso and high-iso diets were modest in degree . The high-iso diet result ed in a small but significant decrease in estrone-sulfate ( E1-S ) , a trend toward lower estradiol ( E2 ) and estrone ( E1 ) , and a small but significant increase in SHBG . For the other hormones , the few significant changes noted were also small and probably not of physiological importance . There were no significant effects of the low-iso or high-iso diets on vaginal cytology or endometrial biopsy results . These data suggest that effects of isoflavones on plasma hormones per se are not significant mechanisms by which soy consumption may exert estrogen-like effects in postmenopausal women . These data also show that neither isoflavones nor soy exert clinical ly important estrogenic effects on vaginal epithelium or endometrium",
"AIM The purpose of the present study was to carry out a comparative histological analysis of the endometrium in postmenopausal women who made use of phytoestrogens in order to assess the efficacy and possible side effects of this therapy . METHODS This study was carried out by forming 2 groups in order to compare the results . One group was given a dietary supplement of phytoestrogens for 24 months , whereas the other was given a placebo for the same period of time . At the beginning of this study endometrial bioptical sample s were taken from those patients who had been previously selected at our University Centre . This study was started only with those postmenopausal patients whose bioptical sample was histologically suitable , and it was neither hyperplastic , nor cancerous and nor secretive . During these 24 months there have been frequent contacts aim ed at verifying the st and ard therapeutic behaviour , symptoms and appearance of side effects . At the end of the study new and final bioptical sample s of endometrium were taken from both groups . RESULTS One-hundred and forty-one patients completed the study . Five patients ( 3.4 % ) who were su bmi tted to phytoestrogens therapy showed a weak proliferative endometrium bioptical sample . All the other biopsies at the beginning and at the end of the study showed an atrophic and inactive sample . Hot flushes , night sweats , vaginal dryness and dyspareunia improved at the end of the study for the group treated with phytoestrogens as compared to the one treated with a placebo . Although there have not been very significant differences ias to symptoms and side effects , it was noted that insomnia was the most common symptom in the group treated with non-hormonal therapy based on phytoestrogens . CONCLUSIONS Phytoestrogens did not cause any sensitive and worrisome stimulation of the endometrial mucosa . Insomnia was more frequent in the group treated pharmacologically in the 24 months of the study , whereas hot flushes , night sweats , vaginal dryness and dyspareunia persisted or increased as compared to the beginning of the study in the group treated with a placebo , but this did not occur for the group treated with phytoestrogens",
"PURPOSE Hot flashes represent a significant clinical problem for some breast cancer survivors . Safe , effective treatment is needed for this prominent clinical problem . Although it has been shown that estrogen or progesterone replacement therapy can alleviate this problem , there are continued safety concerns regarding the use of hormonal therapies in these women . Based on anecdotal information , we hypothesized that soy-derived phytoestrogens , weak estrogen-like substances in the soybean that demonstrate estrogen agonist and /or antagonist effects when they bind to estrogen receptors , could alleviate hot flashes . This current trial was design ed to investigate this hypothesis . PATIENTS AND METHODS This double-blind clinical trial involved breast cancer survivors with substantial hot flashes . After r and omization , patients underwent a 1-week baseline period with no therapy . This was followed by 4 weeks of either soy tablets or placebo . The patients then crossed over to the opposite arm in a double-blind manner for the last 4 weeks . Patients completed a daily question naire documenting hot flash frequency , intensity , and perceived side effects . RESULTS Of the 177 women who were r and omized and started the study substance , 155 ( 88 % ) provided useable data over the first 5 weeks ; 149 provided usable data over the entire 9 weeks . There was no suggestion that the soy product was more effective in reducing hot flashes than the placebo . At study completion , patients preferred the soy product 33 % of the time , the placebo 37 % of the time , and neither substance 31 % of the time . No toxicity was observed . CONCLUSION The soy product did not alleviate hot flashes in breast cancer survivors",
"BACKGROUND S-equol , a metabolite of the soy isoflavone daidzein , has been proposed as having potential for relief of menopausal symptoms . This study compared the efficacy of the natural S-equol supplement , SE5-OH , with isoflavones for relieving hot flashes and other menopausal symptoms . METHODS An 8-week r and omized , double-blind , active comparator trial with SE5-OH was conducted in postmenopausal women ( aged 45 - 65 years ) , who experienced ≥5 hot flashes/day . Participants ( n=102 ) were assigned to one of four treatment groups : 10 ( n=24 ) , 20 ( n=27 ) , or 40 ( n=25 ) mg S-equol/day or soy isoflavones ( n=26 ) . Participants recorded their hot flash frequency and rated their menopause symptom severity . RESULTS Reductions in hot flash frequency at week 8 were similar for all treatment groups . However , based on analyses of the cumulative effect for the 8-week period , 40 mg/day S-equol had a greater reduction of hot flash frequency compared to isoflavones ( p=0.021 ) . A subgroup analysis further indicated that for subjects with > 8 hot flashes/day at baseline , 20 and 40 mg/day S-equol were superior to isoflavones in reducing hot flash frequency ( p=0.045 and p=0.001 , respectively ) . In addition , 10 and 20 mg/day S-equol improved muscle and joint pain score compared with isoflavones ( p=0.003 and p=0.005 , respectively ) . CONCLUSIONS S-equol , 10 mg/day , appears to be as effective as soy isoflavones at reducing hot flash frequency and more effective for relieving muscle and joint pain in postmenopausal women . S-equol , ≥20 mg/day , alleviates hot flashes to a greater extent than soy isoflavones in those women who experience > 8 hot flashes/day",
"Objective This double‐blind , r and omized study was aim ed at evaluating comparatively , in postmenopausal women , the activity of a st and ardized soy extract ( SOYSELECT ) and placebo when given alone or in combination with conjugated equine estrogens ( CEE ) on early climacteric symptoms . Lipid profile , pituitary hormones , osteocalcin and endothelin levels , and vaginal and endometrial parameters were also evaluated . Design Participants in the control group were given placebo , and participants in the treated group were given 400 mg/day of a st and ardized soy extract , corresponding to 50 mg/daily of isoflavones . After 6 weeks of treatment , CEE was also then given to each participant at a dose of 0.625 mg/day for 4 weeks . At the end of this period , soy and placebo treatment were suspended , and , until the end of the study ( week 12 ) , participants were administered 10 mg/day of medroxyprogesterone acetate in association with CEE ( 0.625 mg/day ) . Results When compared with pretreatment data , on week 6 of the study , a significant ( p the mean number of hot flushes per week was observed in participants who were receiving the st and ardized soy extract , whereas a more marked relief was observed in both soy and placebo groups during CEE administration . Concurrently , the severity of hot flushes , assessed by means of the Greene climacteric scale , was also reduced in the soy group participants ( p on vaginal cytology , endometrial thickness , uterine artery pulsatility index , or metabolic and hormonal parameters tested . Finally , CEE‐related changes on genital tract , uterine vascular compartment , and pituitary hormones were not modified by soy treatment . Conclusions SOYSELECT may be a safe and efficacious therapy for relief of hot flushes in women who refuse or have contraindications for hormone replacement therapy . ( Menopause 2000;7:105‐111 . © 2000 , The North American Menopause Society .",
"Objective We examined the change in menopausal symptoms in response to 24 weeks of isoflavone-rich ( 80.4 mg/day ) and isoflavone-poor ( 4.4 mg/day ) soy protein isolate treatment in perimenopausal women . Design In this double-blind 24-week study , 69 women were r and omized to treatment : isoflavone-rich soy protein ( n = 24 ) , isoflavone-poor soy protein ( n = 24 ) , or whey protein control ( n = 21 ) . A Menopausal Index was used to assess change in hot flushes and night sweats , as well as other symptoms , at baseline , week 12 , and week 24 . Results Repeated measures analysis of variance indicated no treatment effect on change in hot flush ( p = 0.18 ) and night sweat ( p = 0.92 ) frequency , whereas there was a significant decline in hot flush ( p = 0.0003 ) and night sweat ( p = 0.0007 ) frequency with time in all treatment groups . & khgr;2 analyses indicated no treatment effect on severity of hot flushes or night sweats at any time point , as well as no treatment effect on frequency or severity of other vasomotor symptoms . At the completion of the study , we found no treatment effect on retrospective perception of frequency , duration , or severity of hot flushes or night sweats . Since time had a significant effect on symptoms with all groups reporting a decline in overall symptoms , this indicated either a placebo effect or simply an improvement in symptoms during the study . Conclusion In this study , we found no evidence that isoflavone-rich or isoflavone-poor soy protein provided relief of vasomotor or of other menopausal symptoms",
"OBJECTIVES The primary aim was to assess whether the use of an isoflavone extract containing 40 mg or 160 mg of total isoflavones affects the frequency of menopausal flushes and other symptoms . The secondary aims were assessment s of possible effects on menopause symptom scores and biological measures of estrogen activity . METHODS A r and omized , double-blind , placebo-controlled prospect i ve trial of 37 postmenopausal women with symptoms of estrogen deficiency was performed over a 12-week period . The women were r and omized to three treatment groups : placebo , 40 mg or 160 mg , delivered in tablet form . RESULTS There was no significant difference in the incidence of flushes between the three groups at trial conclusion . There was no difference between the groups in Greene Menopause Symptom Scores , vaginal pH , levels of follicle stimulating hormone ( FSH ) , sex hormone binding globulin ( SHBG ) or total cholesterol , liver function or blood parameters . A statistically significant increase in high-density lipoprotein ( HDL ) cholesterol of 18.1 % ( p = 0.038 ) occurred in the 40-mg group . CONCLUSION A large placebo response and inadvertent use of dietary isoflavones in the placebo group may have obscured a significant change in flushing frequency . Previous uncontrolled studies cl aim ing a beneficial effect of foods with a high isoflavone content on menopausal symptoms may have been confounded by a large placebo response",
"Objective : To investigate the effects of a novel dietary supplement containing soy isoflavones and Actaea racemosa Linnaeus ( formerly called Cimicifuga racemosa L. ) on climacteric symptoms in healthy perimenopausal women . Design : In a multicenter , r and omized , placebo-controlled , double-blind study , 124 women experiencing at least five vasomotor symptoms every 24 hours were r and omized to receive daily either a phytoestrogen-containing supplement ( n = 60 ) or placebo ( n = 64 ) for 12 weeks . The modified Kupperman Index and Greene Climacteric Scale , a visual analogue scale design ed to measure quality of life and the daily number and severity of hot flushes , was used in the screening period and in weeks 6 and 12 . Changes in these scores from baseline were calculated . Results : At weeks 6 and 12 , all scores in both groups had improved compared with baseline , though the overall difference in scores between the groups was not statistically significant . Conclusion : The supplement containing soy isoflavones and A racemosa L. had no statistically significant effect on climacteric symptoms in perimenopausal women experiencing at least five vasomotor symptoms per day",
"OBJECTIVES To evaluate the preliminary efficacy and safety of Pueraria mirifica in the treatment of vasomotor symptoms . DESIGN Open-label study . SETTING Hat Yai Regional Hospital , Thail and . SUBJECTS Pre and postmenopausal women with vasomotor symptoms , such as hot flushes and night sweats . Other unpleasant symptoms , urogenital and psychological symptoms , were also evaluated . MATERIAL AND METHOD Patients were enrolled voluntarily and r and omly received 50 mg or 100 mg of Pueraria mirifica in capsules , once daily for six months . RESULTS Of the 48 enrolled patients , 11 cases were excluded for failing to complete the initial work-up . Thirty-seven cases were evaluated . 20 of 37 ( 54.1 % ) r and omly received a dose of 50 mg/day of Pueraria mirifica ( Group A ) , and 17 of 37 ( 45.9 % ) received 100 mg/day of Pueraria mirifica ( Group B ) . The mean of the modified Greene climacteric scale decreased from 35.6 to 26.6 , 17.2 and 15.1 in group A , while group B , declined from 32.6 to 21.0 , 14.8 and 13.6 at 1- , 3- and 6-month respectively . The mean serum estradiol , fluctuated from the baseline of 76.6 to 55.4 , 56.7 , 72.5 , 69.2 , 114.2 and 74.5 pg/ml at 1- , 2- , 3- , 4- , 5- and 6-month respectively . Whereas the mean serum follicle-stimulating hormone (FSH)/luteinizing hormone ( LH ) was stable in the range of ; 27.1/12.6 , 28.3/12.9 and 22.5/11.4 mIU/ml at baseline , 3- and 6-month respectively . CONCLUSIONS Pueraria mirifica , containing phytoestrogens , relatively alleviated the climacteric symptoms in perimenopausal women . The transient negative profiles occurred in a small number of subjects that included anemia , and liver profiles . While there was a slight decrease in lipoproteins and an increase in hormonal profiles , Pueraria mirifica demonstrates great promise in the treatment of climacteric symptoms among perimenopausal women . However , optimal doses should be clinical ly assessed , to meet appropriate individual responses",
"Objective To analyze the impact of soy protein dietary supplements containing phytoestrogens on menopausal symptoms in healthy postmenopausal women . Methods A double-blind , placebo-controlled trial was conducted in 94 healthy postmenopausal women aged 50–75 years , with 44 r and omized to soy supplements containing 118 mg of isoflavones ( daidzein , genistein , glycitein and their respective glycosides ) , and 50 to an identically presented casein placebo . A vali date d question naire on menopausal symptoms was administered at baseline and at 3 months of treatment . Compliance was assessed by high-performance liquid chromatography assay of urinary phytoestrogens . Statistical analysis was completed using non-parametric statistical methods and multivariate analysis . Results At baseline 80 % of women recruited were experiencing menopausal symptoms , although symptom severity was mild . Those consuming phytoestrogen supplements had 13- and 17-fold increases in urinary excretion of genistein and daidzein , respectively , with no change in the placebo group . Active soy supplements did not significantly alter either individual symptoms or specific symptom category scores when compared to placebo . Within-group comparisons revealed that the active group reported a significant improvement in vaginal dryness ( p = 0.01 ) , libido ( p = 0.009 ) , facial hair ( p = 0.04 ) and dry skin ( p = 0.027 ) . However , similarly , those on placebo reported an improvement in libido ( p = 0.015 ) , facial hair ( p = 0.014 ) and dry skin ( p = 0.011 ) but not vaginal dryness . Conclusions In this group of 94 older postmenopausal women with a high frequency of mild menopausal symptoms , 3 months of soy supplements containing phytoestrogens did not provide symptomatic relief compared with placebo ",
"Objective : This study was design ed to assess endometrial histology in postmenopausal women not taking hormone replacement therapy , to evaluate side effects and efficacy of phytoestrogens in treating menopause-associated symptoms , and to determine whether 6 months of phytoestrogen supplementation altered endometrial histology . Methods : We performed a prospect i ve , double-blinded , r and omized , placebo-controlled trial comparing the effects of 6 months of dietary phytoestrogen supplemtation versus placebo in postmenopausal women . Baseline endometrial biopsies were performed and , if adequate , nonhyperplastic , noncancerous , and non-ovulatory , subjects were r and omly assigned to receive daily placebo or soy cereal supplementation for 6 months . Study subjects completed baseline and weekly dietary , symptom , and side effect logs . Repeat endometrial biopsies were obtained at 6 months . Results : Subjects were recruited from January 1998 through June 2000 . Twenty-seven subjects were r and omized , and 19 completed the study . One ( 3.7 % ) baseline endometrial sample was weakly proliferative . All other baseline and final biopsies were consistent with atrophic , inactive endometrium . The maximum risk of endometrial stimulation with phytoestrogens is 35 % . Hot flushes , night sweats , and vaginal dryness were significantly less severe at the final week of the study compared with baseline in the placebo group . Insomnia was more common in the treated group . There were no other statistically significant differences in symptoms or side effects . Conclusion : Phytoestrogens did not cause stimulation of the endometrium . Insomnia was more frequent over the 6-month study in the soy group , whereas hot flushes , night sweats , and vaginal dryness improved from baseline in the placebo group but not in the soy group",
"OBJECTIVES To assess the efficacy of a product containing isoflavones and other plant extracts ( BIO ) on whole menopausal symptomatology and plasma lipids profile . METHODS Multicentre , r and omized , double blind , placebo controlled clinical investigation on 125 menopausal women r and omly assigned to two groups treated for 6 months with placebo or one tablet daily of an herbal product containing 72 mg/dose of isoflavones of different plants origin and other plant extracts ( BIO ) . Primary end-point : Kupperman Menopause Index ( KI ) variations ; secondary end-point : activity on plasma lipids profile and clinical global impression ( CGI ) on efficacy and tolerability by investigators and patients . The usual parametric test ( paired Student t test ) was performed to evaluate the significance . In case of non-applicability of parametric tests , the non-parametric Mann-Whitney U test was used . The differences where considered significant at p KI showed a significant decrease ( p KI reduction was significantly higher ( p=0.0265 ) than in the placebo group after 4 and 6 months of treatment . In the BIO treated patients the LDL cholesterol showed a borderline but not significant reduction compared to placebo ( p=0.0608 ) and triglyceride ( TG ) a significant ( p=0.0151 ) decrease compared to placebo . The investigator 's and patient 's CGI on BIO group where superior as compared to placebo . Clinical tolerability was good in booth groups . CONCLUSION On the basis of positive effects on KI and lipids profile as well as of good clinical tolerability , BIO can be considered one of the possible alternative therapy for conventional HRT",
"AIM Dietary soy supplementation may reduce the incidence of hot flushes in postmenopausal women due to the presence of phytoestrogens in soy foods . The aim of this study was to assess the effects of a 3-month administration of different doses of either oral or transdermal soy isoflavones on climacteric complaints in postmenopausal women . METHODS Sixty postmenopausal women were assigned r and omly to one of the following groups : groups A and B received 50 mg/day or 75 mg/day of oral isoflavones respectively , while groups C and D received 6 mg/day or 12 mg/day of transdermal isoflavones . A control group ( group E ) was composed of 15 patients that did not receive any treatment . Hot flushes , Kupper-man index and vaginal dryness at baseline and then after 5 , 9 and 13 weeks were evaluated . RESULTS The isoflavone treatment led to a progressive significant ( p number of hot flushes in the groups A , B and D with a dose-related effect in group D. At week 13 , the Kupperman index and hot flush score decreased significantly in all the treated groups , while vaginal dryness score was reduced only in group B. CONCLUSION Our findings suggest that both oral and transdermal soy isoflavones are effective to attenuate slight to moderate menopausal neurovegetative symptoms with a dose-related effect",
"It has been well documented that the frequency of vasomotor menopausal symptoms , such as hot flashes and night sweats , of Japanese menopausal women is less than that of Western women . High intake of soy isoflavones in the traditional Japanese diet has been postulated as the possible explanation of the difference . Epidemiological studies have reported that the content of equol , which is a biologically active metabolite of the isoflavone , daidzein , is lower in the women who complain of severe vasomotor symptoms . To investigate the involvement of equol in the manifestation of menopausal symptoms , especially vasomotor symptoms , and the possible therapeutic role of a supplement containing equol ( natural S-equol developed by Otsuka Pharmaceutical ) on the menopausal symptoms of Japanese women , 3 r and omized clinical trials were conducted . The studies indicated that a daily dose of 10 mg of natural S-equol improved menopausal symptoms . In the confirmation study , menopausal women who were equol nonproducers who consumed 10 mg/d of natural S-equol for 12 wk had significantly reduced severity and frequency of hot flashes as well as a significant reduction in the severity of neck or shoulder stiffness . The equol-ingesting group also showed trends of improvement in sweating and irritability and a significant improvement in the somatic category symptoms . Thus , it is concluded that the supplement containing natural S-equol , a novel soybean-derived functional component , has a promising role as an alternative remedy in the management of menopausal symptoms",
"OBJECTIVE To determine the effects of 5 years of treatment with soy phytoestrogens on histological characteristics of endometrium in postmenopausal women . DESIGN R and omized , double-blind , placebo-controlled study . SETTING Centre of Perinatal and Reproductive Medicine , Department of Gynecological , Obstetrical , and Pediatric Sciences , University of Perugia , Italy . PATIENT(S ) Three hundred seventy-six postmenopausal healthy women , all with intact uterus . INTERVENTION(S ) Women were distributed in two different groups using r and omized criteria : group A ( n = 179 ) patients received soy tablets ( 150 mg of isoflavones per day ) for 5 years ; group B ( n = 197 ) patients received identical appearing placebo tablets for 5 years . MAIN OUTCOME MEASURE(S ) Results of endometrial histology from biopsies obtained at baseline , 30 months , and 5 years after the beginning of the treatment . RESULT ( S ) Two hundred ninety-eight women completed the 5-year treatment . No cases of malignancy were detected during biopsy . Seventy percent of women undergoing treatment with soy phytoestrogens had an endometrium classified as atrophic or nonassessable versus 81 % receiving placebo . The occurrence of endometrial hyperplasia was significantly higher in group A ( 3.37 % vs. 0 % ) . CONCLUSION ( S ) Long-term treatment ( up to 5 years ) with soy phytoestrogens was associated with an increased occurrence of endometrial hyperplasia . These findings call into question the long-term safety of phytoestrogens with regard to the endometrium",
"The objective of this study was to evaluate the efficacy of flaxseed meal and flaxseed extract in reducing climacteric symptoms of menopausal women . Ninety menopausal women were r and omly distributed into three study groups : group I received 1 g per day of flaxseed extract containing at least 100 mg of secoisolariciresinol diglucoside ( SDG ) , group II received 90 g per day of flaxseed meal containing at least 270 mg of SDG , and group III received 1 g per day of collagen ( placebo group ) . Subjects were assessed for menopausal symptoms by the Kupperman index at the beginning and at the end of the 6 months of treatment . Subjects were also assessed for endometrial thickness and vaginal cytology . The Kupperman index values at the beginning and end of the treatments were analyzed using the paired t-test . Both the flaxseed extract ( P=.007 ) and the flaxseed meal ( P=.005 ) were effective in reducing the menopausal symptoms when compared with the placebo control ( P=.082 ) . Alternatively , the changes in Kupperman index were also computed and su bmi tted to analysis of variance . In this case , no significant differences were found ( P=.084 ) although the data indicate a decreasing tendency for the Kupperman index by both the flaxseed extract and the flaxseed meal groups . Neither the flaxseed extract nor the flaxseed meal exerted clinical ly important estrogenic effects on the vaginal epithelium or endometrium as revealed by the absence of changes in the blood levels of follicle stimulating hormone and estradiol , as well as in the endometrial thickness , and vaginal epithelial maturation value . No serious adverse events related to the treatments were reported . Although the results of the present study do not allow an unequivocal conclusion about the action of flaxseed on the menopausal symptoms , they suggest that it could be premature to conclude that no such action exists . Clearly the matter still deserves further experimental attention"
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